UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
(Mark One)
☐
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
For the fiscal year ended December 31, 2017
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
☐
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of event requiring this shell company report: Not applicable
For the transition period from ____ to _____
Commission file number 001-35548
Kamada Ltd.
(Exact name of registrant as specified in its charter)
N/A
(Translation of Registrant’s name into English)
State of Israel
(Jurisdiction of incorporation or organization)
2 Holzman St.
Weizmann Science Park
P.O Box 4081
Rehovot 7670402
Israel
(Address of principal executive offices)
Amir London, Chief Executive Officer
2 Holzman St., Weizmann Science Park
Rehovot 7670402, Israel
+972 8 9406472
Securities registered or to be registered pursuant to Section 12(b) of the Act.
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Title of Each Class
Ordinary Shares, par value NIS 1.00 each
Name of Each Exchange on which Registered
The NASDAQ Stock Market LLC
Securities registered or to be registered pursuant to Section 12(g) of the Act. None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.
As of December 31, 2017, the Registrant had 40,262,819 Ordinary Shares outstanding.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
☐ Yes ☒ No
If this report is an annual report or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
☐ Yes ☒ No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
☒ Yes ☐ No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
☒ Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer”,
“accelerated filer”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☐ Emerging growth company ☒
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐
†The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP ☐
International Financing Reporting Standards as issued by the
International Accounting Standards Board ☒
Other ☐
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Item 17 ☐ Item 18 ☐
☐ Yes ☒ No
TABLE OF CONTENTS
PART I
Item 1. Identity of Directors, Senior Management and Advisers
Item 2. Offer Statistics and Expected Timetable
Item 3. Key Information
Item 4. Information on the Company
Item 4A. Unresolved Staff Comments
Item 5. Operating and Financial Review and Prospects
Item 6. Directors, Senior Management and Employees
Item 7. Major Shareholders and Related Party Transactions
Item 8. Financial Information
Item 9. The Offer and Listing
Item 10. Additional Information
Item 11. Quantitative and Qualitative Disclosures About Market Risk
Item 12. Description of Securities Other Than Equity Securities
PART II
Item 13. Defaults, Dividend Arrearages and Delinquencies
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds
Item 15. Controls and Procedures
Item 16A. Audit committee financial expert
Item 16B. Code of Ethics
Item 16C. Principal Accountant Fees and Services
Item 16D. Exemptions from the Listing Standards for Audit Committees
Item 16E. Purchase of Equity Securities by the Issuer and Affiliated Purchasers
Item 16F. Change in Registrant's Certifying Accountant
Item 16G. Corporate Governance
Item 16H. Mine Safety Disclosure
PART III
Item 17. Financial Statements
Item 18. Financial Statements
Item 19. Exhibits
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129
129
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148
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149
149
149
149
150
150
150
151
152
152
152
In this Annual Report on Form 20-F (“Annual Report”), unless the context indicates otherwise, references to “NIS” are to the legal currency of Israel, “U.S. dollars,” “$” or “dollars” are to
United States dollars, and the terms “we,” “us,” “our company,” “our,” and “Kamada” refer to Kamada Ltd., along with its consolidated subsidiaries.
This Annual Report contains forward-looking statements that relate to future events or our future financial performance, which express the current beliefs and expectations of our management.
Such statements involve a number of known and unknown risks, uncertainties and other factors that could cause our actual future results, performance or achievements to differ materially from any future
results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements include all statements that are not historical facts and can be identified by
words such as, but without limitation, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “target,” “likely,” “will,” “would,” “could,” and similar expressions or phrases. We have based
these forward-looking statements largely on our management’s current expectations and future events and financial trends that we believe may affect our financial condition, results of operation, business
strategy and financial needs. Forward-looking statements include, but are not limited to, statements about:
·
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Our focus in the Alpha-1 Antitrypsin (“AAT”) deficiency ("AATD") field, and becoming the innovator in this field by developing different therapeutic approaches to AATD independently
and through collaborations with strategic partners;
our expectation that our revenues will grow by approximately 13-17% in 2018 compared to our revenues for 2017 and that we will achieve our revenue goal of $116-120 million in 2018;
our belief that our relationships with our strategic partners will lead to increased revenues and other benefits in the future and that such relationships, including with Shire plc.
(“Shire”), and Kedrion S.p.A ("Kedrion") will continue without disruption;
our expectation that the minimum aggregate revenue for Glassia for the years 2018 to 2020 under our agreement with Shire will reach approximately $177 million and may be expanded
to $228 million during that period;
our expectation that our product offerings in our Proprietary Products segment will increase until 2020 (thereafter, Shire has no obligation to purchase a minimum amount of Glassia),
that Shire will begin selling Glassia produced in its own manufacturing facility as early as 2021 and pay us royalties and that Shire will have an FDA approved production facility by
2021;
our expectation that as Shire transitions to producing Glassia in its own facilities, we will incur a substantial reduction in revenues (as well as costs of goods sold), driven by the
reduction in Glassia manufacturing, and our intent to partially offset such decrease in revenues by income from royalty payments from Shire on sales of Glassia and continued increased
sales of Glassia in rest of the world countries through local distributors and the KEDRAB product in the United States;
our ability to launch our anti-rabies immunoglobulin product for prophylaxis treatment of rabies disease in the United States in 2018 in collaboration with Kedrion (under the
trademark "KEDRAB" in the U.S.) and our expectations regarding future sales of the product in the U.S. and in other territories (under the trademark "KamRAB"), including that a
recently signed supply agreement from November 2017 for marketing of KamRAB will generate total revenues through 2020 for our Company in the total amount of approximately $13
million;
our belief that receiving FDA approval for marketing of our anti-rabies immunoglobulin (under the trademark "KEDRAB" in the U.S.) will assist us in our efforts to register the product
in additional countries where it is not currently registered, and our belief that this would lead to additional sales worldwide;
1
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·
·
·
·
·
·
·
·
·
·
our belief that we will be able to continue to meet our customers' demand for AAT and anti-rabies immunoglobulin;
our belief that U.S-based and other healthcare providers would seek to diversify their source of anti-rabies immunoglobulin, using our product;
our ability to procure adequate quantities of plasma and fraction IV from our suppliers, which are acceptable for use in our manufacturing processes;
our ability to maintain compliance with government regulations and licenses;
our ability to identify growth opportunities for existing products and our ability to identify and develop new product candidates;
our belief that the market opportunity for AAT products will grow;
the beneficial characteristics of Inhaled AAT for AATD, which we believe may result in our increased profitability;
our expectations are that our discussions with the U.S. Food and Drug Administration (the “FDA”) regarding the clinical and regulatory pathway for registration in the United States of
Inhaled AAT for AATD, will materialize by mid-2018 and will lead to receiving the FDA approval for our Investigational New Drug (“IND”) application, which will enable us to initiate
a pivotal study for registration thereafter. We intend to use the data from this study, if successful, to resubmit a Marketing Authorization Application ("MAA") in the European Union with
the European Medicines Agency (the “EMA”);
our belief that Inhaled AAT for AATD will increase patient convenience and reduce the need for patients to use intravenous infusions of AAT products, thereby decreasing the need for
clinic visits or nurse home visits and reducing medical costs;
our belief that Inhaled AAT for AATD will enable us to treat significantly more patients from the same amount of plasma and production capacity and therefore increase our profitability;
the various uses of AAT products to potentially be effective against various diseases, including Graft versus Host Disease ("GvHD"), type-1 diabetes ("T1D") and prevention of lung
transplantation rejection, and our ability to generate the needed data to potentially attract strategic partner(s) to collaborate in the further development of these indications;
our expectation that we will report interim results from the Phase II clinical study of our intravenous AAT product to prevent lung transplantation rejection in the second half of 2018
and top-line results in the second half of 2019;
the timing of, and our ability to, obtain and/or maintain regulatory approvals for our products and new product candidates, the rate and degree of market acceptance, and the clinical
utility of our products;
2
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·
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·
the potential market opportunities for our products and product candidates;
our plan to develop a recombinant AAT product;
our expectations regarding the potential actions or inactions of existing and potential competitors of our products;
legislation or regulation in countries where we sell our products that affect product pricing, reimbursement, access or distribution channels;
the impact of geographic and product mix on our total revenues and gross profit;
our ability to obtain and maintain protection for the intellectual property relating to or incorporated into our technology and products;
the impact of our research and development expenses on our financial results as we continue developing product candidates;
our expectations regarding our ability to utilize Israeli tax incentives against future income; and
our expectations regarding taxation, including that we will not be classified as a passive foreign investment company for the taxable year ending December 31, 2017.
All forward-looking statements involve risks, assumptions and uncertainties. You should not rely upon forward-looking statements as predictors of future events. The occurrence of the events
described, and the achievement of the expected results, depend on many events, some or all of which may not be predictable or within our control. Actual results may differ materially from expected
results. See the sections “Item 3. Key Information — D. Risk Factors” and “Item 5. Operating and Financial Review and Prospectus”, as well as elsewhere in this Annual Report, for a more complete
discussion of these risks, assumptions and uncertainties and for other risks and uncertainties. These risks, assumptions and uncertainties are not necessarily all of the important factors that could cause
actual results to differ materially from those expressed in any of our forward-looking statements. Other unknown or unpredictable factors also could harm our results.
All of the forward-looking statements we have included in this Annual Report are based on information available to us on the date of this Annual Report. We undertake no obligation, and
specifically decline any obligation, to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In light of these risks, uncertainties and
assumptions, the forward-looking events discussed in this Annual Report might not occur.
The audited consolidated financial statements for the years ended December 31, 2017, 2016 and 2015 included in this Annual Report have been prepared in accordance with the international
financial reporting standards (“IFRS”) as issued by the international accounting standards board (“IASB”). None of the financial information in this Annual Report has been prepared in accordance with
accounting principles generally accepted in the United States (“U.S. GAAP”).
Unless otherwise noted, NIS amounts presented in this Annual Report are translated at the rate of $1.00 = NIS 3.467, the exchange rate published by the Bank of Israel as of December 31, 2017.
3
PART I
Item 1. Identity of Directors, Senior Management and Advisers
Not applicable.
Item 2. Offer Statistics and Expected Timetable
Not applicable.
Item 3. Key Information
A. Selected Financial Data
The following table summarizes our consolidated financial data. We have derived the summary consolidated statements of operations data for the years ended December 31, 2017, 2016 and 2015
and the consolidated balance sheets data as of December 31, 2017 and 2016 from our audited consolidated financial statements included elsewhere in this Annual Report. We have derived the summary
consolidated statements of operations data for the years ended December 31, 2014 and 2013 and the summary consolidated balance sheet data as of December 31, 2015, 2014 and 2013 from our audited
consolidated financial statements not included in this Annual Report.
We have included, in our opinion, all adjustments, consisting only of normal recurring adjustments that we consider necessary for a fair presentation of the financial information set forth in those
summary consolidated statements. Our historical results are not necessarily indicative of the results that should be expected in the future, and our interim results are not necessarily indicative of the results
that should be expected for the full year.
4
The summary of our consolidated financial data set forth below should be read together with our consolidated financial statements and the related notes, as well as the section entitled “Item 5.
Operating and Financial Review and Prospects,” included elsewhere in this Annual Report.
$
$
$
$
$
Consolidated Statements of Operations Data:
Revenues from Proprietary Products
Revenues from Distribution
Total revenues
Cost of revenues from Proprietary Products
Cost of revenues from Distribution
Total cost of revenues
Gross profit
Research and development expenses
Selling and marketing expenses
General and administrative expenses
Operating income (loss)
Financial income
Income (expense) in respect of currency exchange and translation differences
and derivatives instruments, net
Income (expense) in respect of revaluation of warrants to fair value
Financial expense
Income (loss) before taxes on income
Taxes on income
Net income (loss)
Income (loss) attributable to equity holders
Income (loss) per share attributable to equity holders:
Basic
Diluted
Weighted-average number of ordinary shares used to compute income (loss)
per share attributable to equity holders:
Basic
Diluted
Consolidated Statements of Cash Flows:
Cash flows from operating activities
Cash flows from investing activities
Cash flows from financing activities
Consolidated Balance Sheet Data:
Cash, cash equivalents, restricted cash and short-term investments
Trade receivables
Working capital (1)
Total assets
Total liabilities
Total shareholders’ equity
Other Data:
Adjusted net income (loss)(2) (3)
Adjusted EBITDA(2)
____________
2017
2016
Year Ended December 31,
2015
(in thousands, except per share data)
2014
2013
$
79,559
23,266
102,825
51,335
19,402
70,737
32,088
11,973
4,398
8,273
7,444
500
(612)
-
(162)
7,170
269
6,901
6,901
0.18
$
0.18
$
$
55,958
21,536
77,494
37,723
18,411
56,134
21,360
16,245
3,243
7,353
(5,481)
469
127
-
(126)
(5,011)
1,722
(6,733) $
(6,733) $
(0.18) $
(0.18) $
$
42,952
26,954
69,906
30,901
23,640
54,541
15,365
16,530
3,652
6,607
(11,424)
463
625
-
(934)
(11,270)
-
(11,270) $
(11,270) $
(0.31) $
(0.31) $
$
44,389
26,676
71,065
32,617
23,406
56,023
15,042
16,030
2,898
7,593
(11,479)
404
-
-
(2,086)
(13,161)
52
(13,213) $
(13,213) $
(0.37) $
(0.37) $
50,658
19,965
70,623
27,104
17,112
44,216
26,407
12,745
2,100
7,862
3,700
278
(369)
-
(3,142)
467
24
443
443
0.01
0.01
37,970,697
38,045,097
36,418,833
36,418,833
36,245,813
36,245,813
35,971,335
35,971,335
32,714,631
33,385,651
$
3,608
(15,608)
15,320
$
43,019
30,662
67,486
122,110
32,618
89,492
$
1,897
1,637
1,490
$
28,632
19,788
49,871
99,696
32,953
66,743
(13,979) $
11,253
(6,355)
$
28,306
23,071
57,655
101,992
29,485
72,507
(9,918) $
(26,819)
(7,640)
$
51,896
17,514
66,206
119,140
38,723
80,417
$
$
7,384
11,450
$
$
(5,663) $
(909) $
(9,363) $
(6,290) $
(9,462) $
(4,940) $
(3,854)
(3,903)
49,208
74,177
17,882
85,108
139,379
49,409
89,970
9,414
3,156
(1)
(2)
Working capital is defined as total current assets minus total current liabilities.
We present adjusted net income (loss) and adjusted EBITDA because we use these non-IFRS financial measures to assess our operational performance, for financial and operational decision-
making, and as a means to evaluate period-to-period comparisons on a consistent basis. Management believes these non-IFRS financial measures are useful to investors because: (1) they
allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making; and (2) they exclude the impact of non-cash items that are
not directly attributable to our core operating performance and that may obscure trends in the core operating performance of the business.
5
Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, our IFRS results. We expect to continue reporting
non-IFRS financial measures, adjusting for the items described below, and we expect to continue to incur expenses similar to certain of the non-cash, non-IFRS adjustments described below.
Accordingly, unless otherwise stated, the exclusion of these and other similar items in the presentation of non-IFRS financial measures should not be construed as an inference that these
items are unusual, infrequent or non-recurring. Adjusted net income (loss) and adjusted EBITDA are not recognized terms under IFRS and do not purport to be an alternative to IFRS net
income (loss) as an indicator of operating performance or any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of adjusted
net income (loss) or adjusted EBITDA may not be comparable to other similarly titled measures of other companies.
Adjusted net income (loss) is defined as net income (loss), plus non-cash share-based compensation expenses and plus a one-time management compensation payment associated with our
successful U.S. initial public offering. Our management believes that excluding non-cash charges related to share-based compensation provides useful information to investors because of its
non-cash nature, varying available valuation methodologies among companies and the subjectivity of the assumptions and the variety of award types that a company can use under the
relevant accounting guidance, which may obscure trends in our core operating performance. Our management believes that excluding the one-time management compensation payment
associated with our successful U.S. initial public offering is useful to investors because of the extraordinary, non-recurring nature of the expense.
(3)
Adjusted EBITDA is defined as net income (loss), plus income tax expense, plus financial expense, net, plus depreciation and amortization expense, plus non-cash share-based compensation
expenses, plus or minus income or expense in respect of exchange and translation differences and derivatives instruments not designated as hedging, and plus one-time management
compensation payment. Management believes that adjusted EBITDA provides useful information to investors for the same reasons discussed above for adjusted net income (loss).
The following tables set forth adjusted net income (loss) and adjusted EBITDA and also reconcile these figures to the IFRS measure net income (loss):
Net income (loss)
Non-cash share-based compensation expenses
One-time management compensation payment
Adjusted net income (loss)
Net income (loss)
Income tax expense
Financial expense, net
Depreciation and amortization expense
Non-cash share-based compensation expenses
Income (expense) in respect of translation differences and derivatives
instruments, net
One-time management compensation payment
Adjusted EBITDA
$
$
$
2017
2016
Year Ended December 31,
2015
(in thousands)
2014
2013
6,901
483
-
7,384
$
$
(6,733) $
1,071
-
(5,663) $
(11,270) $
1,907
-
(9,363) $
(13,213) $
3,751
-
(9,462) $
2017
2016
Year Ended December 31,
2015
(in thousands)
2014
2013
$
6,901
269
(338)
3,523
483
612
(6,733) $
1,722
(343)
3,501
1,071
(127)
-
(909) $
(11,270) $
-
471
3,227
1,907
(625)
-
(6,290) $
(13,213) $
52
1,682
2,788
3,751
-
-
(4,940) $
443
1,327
1,386
3,156
443
24
2,864
3,001
1,327
369
1,386
9,414
$
11,450
$
6
B. Capitalization and Indebtedness
Not applicable.
C. Reasons for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
You should consider carefully the risks and uncertainties described below, together with all of the other information in this Annual Report, including the consolidated financial statements and the related
notes included elsewhere in this Annual Report. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently
believe are not material, may also become important factors that adversely affect our business. If any of the following risks actually occurs, our business, financial condition, results of operations, and
future prospects could be materially and adversely affected.
Risks Related to Our Proprietary Products Segment
Our business is currently highly concentrated on our flagship product, Glassia, and our largest geographic region, the United States. Any adverse market event with respect to such product or the
United States would have a material adverse effect on our business.
We rely heavily upon the sales of our AAT intravenous product, Glassia. Revenue from our intravenous AAT products for the treatment of AATD comprised approximately 64%, 56% and 43% of
our total revenues for the years ended December 31, 2017, 2016 and 2015 respectively. If Glassia were to lose significant sales, or was substantially or completely displaced in the market, we would lose a
significant and material source of our total revenues. Similarly, if Glassia were to become the subject of litigation and/or an adverse governmental ruling requiring us to cease the manufacturing, export or
sales of Glassia, our business would be adversely affected.
In addition, we have a partnership arrangement with Shire, pursuant to which Shire is the sole distributor of Glassia in the United States, Canada, Australia and New Zealand. Shire is a global
specialty biopharmaceutical public company listed on the Nasdaq and London Stock Exchanges. The partnership agreement was originally executed in 2010 with Baxter International Inc. ("Baxter").
During 2015, Baxter assigned all its rights under the partnership agreement to Baxalta US Inc. ("Baxalta"), an independent public company which spun-off from Baxter. In 2016, Shire completed its
acquisition of Baxalta, and as a result, all of Baxalta's rights under the partnership agreement were assigned to Shire. Revenue derived from our partnership with Shire, which consists of sales of Glassia
and milestone revenue, accounted for approximately 59%, 52% and 37% of our total revenues in the years ended December 31, 2017, 2016 and 2015, respectively. Additionally, we depend upon Shire for
the supply of fraction IV plasma for our production of Glassia to be sold in the United States. If our relationship with Shire were to deteriorate, our business would be adversely affected. See “—In our
Proprietary Products segment, we currently rely on one of our strategic partners that accounts for a significant portion of our total sales and our distribution plan for our principal product candidate relies
on another strategic partner, and any disruption to our relationships with these distributors would have an adverse effect on our results of operations and profitability.”
7
In our Proprietary Products segment, we currently rely on Shire, which accounts for a significant portion of our total sales, and any disruption to our relationships with Shire would have an adverse
effect on our results of operations and profitability.
Pursuant to our partnership arrangement with Shire, Shire is the sole distributor of Glassia in the United States, Canada, Australia and New Zealand. Sales to Shire accounted for approximately
59%, 52% and 37% of our total revenues in the years ended December 31, 2017, 2016 and 2015, respectively. We also depend upon Shire for the supply of fraction IV plasma for our production of
Glassia to be sold in the United States. See “—We would become supply-constrained and our financial performance would suffer if we were unable to obtain adequate quantities of source plasma or
plasma derivatives or specialty ancillary products approved by the FDA, the EMA, or the regulatory authorities in Israel, or if our suppliers were to fail to modify their operations to meet regulatory
requirements or comply with such requirements or comply with such requirements.”
If we fail to maintain our relationship with Shire, we could face significant costs in finding a replacement distributor for the markets Shire serves for Glassia and a replacement supplier of fraction
IV plasma for Glassia. Delays in establishing a relationship with a new distributor and supplier could lead to a decrease in our sales and a deterioration in our market share compared to one or more of our
competitors. Any of the foregoing developments could have an adverse effect upon our sales, margins and profitability.
Currently, revenue derived from our relationship with Shire consists of sales of Glassia. Pursuant to the Exclusive Manufacturing, Supply and Distribution Agreement, as amended, after 2020,
Shire has no obligation to purchase a minimum amount of Glassia. Additionally, we estimate that Shire will begin selling Glassia produced in its own manufacturing facility as early as 2021, and pay us
royalties. As Shire transitions to producing Glassia in its own facilities, we will incur substantial reduction in revenues (as well as costs of goods sold), driven by the reduction in Glassia manufacturing.
While we will receive royalty payments from Shire based on its Glassia sales until 2040, and we may be able to partially offset the decrease in revenues by expanding sales of other products and in other
territories, our revenues and our operating results would be adversely impacted as we would continue to incur fixed costs relating to our manufacturing facility.
In our Proprietary Products segment, we rely on Kedrion for the sales of our KEDRAB product in the United States, and any disruption to our relationships with Kedrion would have an adverse
effect on our future results of operations and profitability.
Pursuant to the strategic distribution and supply agreement with Kedrion for the clinical development and marketing in the United States of KEDRAB, Kedrion is the sole distributor of
KEDRAB in the United States. Based on receiving the FDA approval for KEDRAB in August 2017, we expect to launch KEDRAB in the United States in 2018. As the sales of KEDRAB in the United
States become material, we will become dependent on Kedrion for its marketing and sales of KEDRAB in the United States.
We also depend upon a subsidiary of Kedrion for the supply of the Hyper-immune plasma which is used for the production of KEDRAB to be sold in the United States. See “—We would become
supply-constrained and our financial performance would suffer if we were unable to obtain adequate quantities of source plasma or plasma derivatives or specialty ancillary products approved by the
FDA, the EMA or the regulatory authorities in Israel, or if our suppliers were to fail to modify their operations to meet regulatory requirements or if prices of the source plasma or plasma derivatives were
to raise significantly.”
If we fail to maintain our relationship with Kedrion, we could face significant costs in finding a replacement distributor for the sales of KEDRAB in the United States and a replacement supplier
of the Hyper-immune plasma which is used for the production of KEDRAB. Delays in establishing a relationship with a new distributor and supplier could lead to a decrease in our sales and a
deterioration in our market share compared to one or more of our competitors. Any of the foregoing developments could have an adverse effect upon our sales, margins and profitability.
8
Our Proprietary Products segment operates in a highly competitive market.
We compete with well-established drug companies, including two to four large competitors for each of our products in the Proprietary Products segment. These large competitors include CSL
Behring Ltd., Shire, Emergent BioSolutions (which acquired Cangene Corporation) and Grifols S.A., which acquired a previous competitor, Talecris Biotherapeutics, Inc., in 2011. We compete against
these companies for, among other things, licenses, expertise, clinical trial patients and investigators, consultants and third-party strategic partners. We also compete with these companies for market share
for certain products in the Proprietary Products segment. Our large competitors have advantages in the market because of their size, financial resources, markets and the duration of their activities and
experience in the relevant market, especially in the United States and countries of the European Union. As a result, they may be able to devote more funds to research and development and new
production technologies, as well as to the promotion of their products and business. These competitors may also be able to sustain for longer periods a deliberate substantial reduction in the price of their
products or services. Some of them also have an additional advantage regarding the availability of raw materials, as they own companies that collect plasma and/or plants which fractionate plasma.
Our products generally do not benefit from patent protection and compete against similar products produced by other providers. Additionally, the development by a competitor of a similar or
superior product or increased pricing competition may result in a reduction in our net sales or a decrease in our profit margins. For example, we believe that our two main competitors in the AAT market
are Grifols and CSL. We estimate that Grifols’ AAT by infusion product for the treatment of AATD, Prolastin A1PI, accounts for at least 50% market share in the United States and more than 70% of sales
in the worldwide market for the treatment of AATD, which also includes sales of Prolastin in different European countries. Apart from its sales through Talecris’ historical business, Grifols is also a local
producer of the product in the Spanish market and operates in Brazil. CSL’s intravenous AAT product is mainly sold in the United States. In 2015, CSL’s intravenous AAT product was granted centralized
marketing authorization in Europe and CSL launched the product in a few European countries during 2016. There is another, smaller local producer in the French market, LFB S.A. In addition, we
estimate that each of Grifols and CSL owns approximately 150 operating plasma collection centers located across the United States.
Similarly, if a new AAT formulation or a new route of administration with a significantly improved characteristics is adopted (including, for example, aerosol inhalation), the market share of our
current AAT product, Glassia, could be negatively impacted. While we are in the process of developing Inhaled AAT for AATD, our competitors may also be attempting to develop similar products or
products that could be substitutions for AAT products, such as gene therapy. For example, Grifols has completed a limited clinical trial for the development of an inhaled formulation of AAT for the
indication of cystic fibrosis. While we believe that these products are in the early stages of development, they may eventually be successfully developed and launched. Furthermore, even if we are able to
commercialize Inhaled AAT for AATD prior to the development of comparable products by our competitors, sales of Inhaled AAT for AATD, subject to approval of such product by the applicable
regulatory authorities, could adversely impact our revenue and growth of sales of Glassia or Glassia related royalties
In addition, our plasma-derived protein therapeutics face, or may face in the future, competition from existing non-plasma products and other courses of treatments. New treatments, such as small
molecules, monoclonal or recombinant products, may also be developed for indications for which our products are now used. We do not currently sell any recombinant products. We have begun
developing recombinant version of AAT, but we cannot be certain that such product will ever be approved or commercialized. See “Item 4. Information on the Company — Our Product Pipeline and
Development Program — Recombinant AAT.” The main advantage of recombinant AAT is its potentially wider availability, and ease of large scale manufacturing. As a result, our product offerings may
remain plasma-derived, even if our competitors offer competing recombinant or other non-plasma products or treatments.
9
Our products involve biological intermediates that are susceptible to contamination, which could adversely affect our operating results.
Plasma and its derivatives, such as fraction IV, are raw materials that are susceptible to damage and contamination and may contain microorganisms that cause diseases in humans, commonly
known as human pathogens, any of which would render such materials unsuitable as raw material for further manufacturing. Almost immediately after collection from a donor, plasma and plasma
derivatives must be stored and transported at temperatures that are at least -20 degrees Celsius (-4 degrees Fahrenheit). Improper storage or transportation of plasma or plasma derivatives by us or third-
party suppliers may require us to destroy some of our raw material. In addition, plasma and plasma derivatives are also suitable for use only for certain periods of time once removed from storage. If
unsuitable plasma or plasma derivatives are not identified and discarded prior to release to our manufacturing processes, it may be necessary to discard intermediate or finished products made from such
plasma or plasma derivatives, or to recall any finished product released to the market, resulting in a charge to cost of goods sold and harm to our brand and reputation. Furthermore, if we distribute
plasma-derived protein therapeutics that are produced from unsuitable plasma because we have not detected contaminants or impurities, we could be subject to product liability claims and our reputation
would be adversely affected.
Despite overlapping safeguards, including the screening of donors and other steps to remove or inactivate viruses and other infectious disease-causing agents, the risk of transmissible disease
through plasma-derived protein therapeutics cannot be entirely eliminated. If a new infectious disease was to emerge in the human population, the regulatory and public health authorities could impose
precautions to limit the transmission of the disease that would impair our ability to manufacture our products. Such precautionary measures could be taken before there is conclusive medical or scientific
evidence that a disease poses a risk for plasma-derived protein therapeutics. In recent years, new testing and viral inactivation methods have been developed that more effectively detect and inactivate
infectious viruses in collected plasma. There can be no assurance, however, that such new testing and inactivation methods will adequately screen for, and inactivate, infectious agents in the plasma or
plasma derivatives used in the production of our plasma-derived protein therapeutics. Additionally, this could trigger the need for changes in our existing inactivation and production methods, including
the administration of new detection tests, which could result in delays in production until the new methods are in place, as well as increased costs that may not be readily passed on to our customers.
Plasma and plasma derivatives can also become contaminated through the manufacturing process itself, such as through our failure to identify and purify contaminants through our manufacturing
process or failure to maintain a high level of sterility within our manufacturing facilities.
Once we have manufactured our plasma-derived protein therapeutics, they must be handled carefully and kept at appropriate temperatures. Our failure, or the failure of third parties that supply,
ship, store or distribute our products, to properly care for our plasma-derived products, may result in the requirement that such products be destroyed.
While we expect to write off small amounts of work-in-process inventories in the ordinary course of business because of the complex nature of plasma and plasma derivatives, our processes and
our plasma-derived protein therapeutics, unanticipated events may lead to write-offs and other costs materially in excess of our expectations. We have, in the past, experienced situations that have caused
us to write off the value of our products. Such write-offs and other costs could materially adversely affect our operating results. Furthermore, contamination of our plasma-derived protein therapeutics
could cause consumers or other third parties with whom we conduct business to lose confidence in the reliability of our manufacturing procedures, which could materially adversely affect our sales and
operating results.
Our ability to continue manufacturing and distributing our plasma-derived protein therapeutics depends on our continued adherence to current Good Manufacturing Practice regulations.
The manufacturing processes for our products are governed by detailed written procedures and regulations that set forth current Good Manufacturing Practice standards (“cGMP”) requirements
for blood products, including plasma and plasma derivative products. Failure to adhere to established procedures or regulations, or to meet a specification set forth in cGMP requirements, could require
that a product or material be rejected and destroyed. There are relatively few opportunities for us to rework, reprocess or salvage nonconforming materials or products. Any failure in cGMP inspection
will affect marketing in other territories, including the U.S. and Israel.
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Our adherence to cGMP regulations and the effectiveness of our quality control systems are periodically assessed through inspections of our manufacturing facility in Beit Kama, Israel by the
FDA, the Israeli Ministry of Health (“IMOH”) and regulatory authorities of other countries. Such inspections could result in deficiency citations, which would require us to take action to correct those
deficiencies to the satisfaction of the applicable regulatory authorities. If serious deficiencies are noted or if we are unable to prevent recurrences, we may have to recall products or suspend operations
until appropriate measures can be implemented. The FDA could also stop the import of products into the United States if there are potential deficiencies. Such deficiencies may also affect our ability to
obtain government contracts in the future. We are required to report certain deviations from procedures to the FDA. Even if we determine that the deviations were not material, the FDA could require us
to take certain measures to address the deviations. Since cGMP reflects ever-evolving standards, we regularly need to update our manufacturing processes and procedures to comply with cGMP. These
changes may cause us to incur additional costs and may adversely impact our profitability. For example, more sensitive testing assays (if and when they become available) may be required or existing
procedures or processes may require revalidation, all of which may be costly and time-consuming and could delay or prevent the manufacturing of a product or launch of a new product.
The biologic properties of plasma and plasma derivatives are variable, which may adversely impact our levels of product yield from our plasma or plasma derivative supply.
Due to the nature of plasma, there will be variations in the biologic properties of the plasma or plasma derivatives we purchase that may result in fluctuations in the obtainable yield of desired
fractions, even if cGMP is followed. Lower yields may limit production of our plasma-derived protein therapeutics because of capacity constraints. If these batches of plasma with lower yields impact
production for extended periods, we may not be able to fulfill orders on a timely basis and the total capacity of product that we are able to market could decline and our cost of goods sold could increase,
thus reducing our profitability.
Usage of our products may lead to serious and unexpected side effects, which could materially adversely affect our business and may, among other factors, lead to our products being recalled and
our reputation being harmed, resulting in an adverse effect on our operating results.
The use of our plasma-derived protein therapeutics may produce undesirable side effects or adverse reactions or events. For the most part, these side effects are known, are expected to occur at
some frequency and are described in the products’ labeling. Known side effects of a number of our plasma-derived protein therapeutics include headache, nausea and additional common protein infusion
related events, such as flu-like symptoms, dizziness and hypertension. The occurrence of known side effects on a large scale could adversely affect our reputation and public image, and hence also our
operating results.
In addition, the use of our plasma-derived protein therapeutics may be associated with serious and unexpected side effects, or with less serious reactions at a greater than expected frequency. This
may be especially true when our products are used in critically ill patient populations. When these unexpected events are reported to us, we typically make a thorough investigation to determine causality
and implications for product safety. These events must also be specifically reported to the applicable regulatory authorities, and in some cases, also to the public by media channels. If our evaluation
concludes, or regulatory authorities perceive, that there is an unreasonable risk associated with one of our products, we would be obligated to withdraw the impacted lot or lots of that product or, in certain
cases, to withdraw the product entirely. Furthermore, it is possible that an unexpected side effect caused by a product could be recognized only after extensive use of the product, which could expose us to
product liability risks, enforcement action by regulatory authorities and damage to our reputation.
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We are subject to a number of existing laws and regulations in multiple jurisdictions, non-compliance with which could adversely affect our business, financial condition and results of operations,
and we are susceptible to a changing regulatory environment, which could increase our compliance costs or reduce profit margins.
Any new product must undergo lengthy and rigorous testing and other extensive, costly and time-consuming procedures mandated by the FDA and similar authorities in other jurisdictions,
including the EMA and the regulatory authorities in Israel. Our facilities must be approved and licensed prior to production and remain subject to inspection from time to time thereafter. Failure to comply
with the requirements of the FDA or similar authorities in other jurisdictions, including a failed inspection or a failure in our reporting system for adverse effects of our products experienced by the users
of our products, or any other non-compliance, could result in warning letters, product recalls or seizures, monetary sanctions, injunctions to halt the manufacture and distribution of products, civil or
criminal sanctions, import or export restrictions, refusal or delay of a regulatory authority to grant approvals or licenses, restrictions on operations or withdrawal of existing approvals and licenses. In
addition, we rely to a large extent on Shire for purposes of most of our regulatory compliance for Glassia and product development and approvals in the United States relating to Glassia. Any failure by
Shire to properly advise us regarding, or properly perform tasks related to, regulatory compliance requirements, could adversely affect us. If our relationship with Shire terminated for any reason, we may
be unable to maintain regulatory compliance on a cost-effective basis, if at all. Any of these actions could cause direct liabilities, a loss in our ability to market Glassia, or a loss of customer confidence in
us or Glassia, which could materially adversely affect our sales, future revenues, reputation, and results of operations. Similarly, we rely on other third-party vendors, for example, in the production,
handling, and distributions of Glassia. If any of these companies incur enforcement action from regulatory authorities due to noncompliance, this could negatively affect product sales, our reputation and
results of operations. In addition, we rely on other distributors of our products, such as Kedrion in the United States, for purposes of our regulatory compliance for the products they distribute in the
territories in which they operate. Any failure by such distributors to properly advise us regarding, or properly perform tasks related to, regulatory compliance requirements, could adversely affect us.
Any changes in our production processes for our products must be approved by the FDA and/or similar authorities in other jurisdictions. Failure to comply with any requirements as to production
process changes dictated by the FDA or similar authorities in other jurisdictions could also result in warning letters, product recalls or seizures, monetary sanctions, injunctions to halt the manufacture and
distribution of products, civil or criminal sanctions, refusal or delay of a regulatory authority to grant approvals or licenses, restrictions on operations or withdrawal of existing approvals and licenses.
In addition, changes in the regulation of our activities, such as increased regulation affecting safety requirements or new regulations such as limitations on the prices charged to customers in the
United States, Israel or other jurisdictions in which we operate, could materially adversely affect our business. In addition, the requirements of different jurisdictions in which we operate may become less
uniform, creating a greater administrative burden and generating additional compliance costs, which would have a material adverse effect on our profit margins.
We would become supply-constrained and our financial performance would suffer if we were unable to obtain adequate quantities of source plasma or plasma derivatives or specialty ancillary
products approved by the FDA, the EMA or the regulatory authorities in Israel, or if our suppliers were to fail to modify their operations to meet regulatory requirements or if prices of the source
plasma or plasma derivatives were to raise significantly.
Our products that generate the majority of our revenues depend on our access to U.S. or European source plasma or its derivative, fraction IV. Our plasma and fraction IV are purchased from
third-party licensed suppliers, which are also responsible for the fractionation process, pursuant to multiple purchase agreements. We have entered into a number of plasma supply agreements with various
third parties in the United States and Europe, some of which are also strategic partners in the distribution of our proprietary products. These agreements contain various termination provisions, including
upon a material breach of either party, force majeure and, with respect to supply agreements with strategic partners, the failure or delay on the part of either party to obtain the applicable regulatory
approvals or the termination of the principal strategic relationship. If we are unable to obtain adequate quantities of source plasma or fraction IV plasma approved by the FDA, the EMA or the regulatory
authorities in Israel from these providers, we may be unable to find an alternative cost-effective source.
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In order for plasma and fraction IV plasma to be used in the manufacturing of our plasma-derived protein therapeutics, the individual centers at which the plasma is collected must be licensed and
approved by the relevant regulatory authorities, such as the FDA or the EMA. When a new plasma collection center is opened, and on an ongoing basis after its licensure, it must be inspected by the FDA,
the EMA or the regulatory authorities in Israel for compliance with cGMP and other regulatory requirements. An unsatisfactory inspection could prevent a new center from being licensed or lead to the
suspension or revocation of an existing license. If we or relevant regulatory authorities determine that a plasma collection center did not comply with cGMP in collecting plasma, we may be unable to use
and may ultimately destroy plasma collected from that center, which may impact on our ability to timely meet our manufacturing and supply obligations. Additionally, if noncompliance in the plasma
collection process is identified after the impacted plasma has been pooled with compliant plasma from other sources, entire plasma pools, in-process intermediate materials and final products could be
impacted, such as through product destruction or rework. Consequently, we could experience significant inventory impairment provisions and write-offs, which could adversely affect our business and
financial results.
In addition, the plasma supplier’s fractionation process must also meet standards of the FDA, the EMA or the regulatory authorities in Israel. If a plasma supplier is unable to meet such standards,
we will not be able to use the plasma derivatives provided by such supplier, which may impact on our ability to timely meet our manufacturing and supply obligations.
If we were unable to obtain adequate quantities of source plasma or plasma derivatives approved by the FDA, the EMA or the regulatory authorities in Israel, we would be limited in our ability to
maintain or increase current manufacturing levels of our plasma derivative products, as well as in our ability to conduct the research required to maintain our product pipeline. As a result, we could
experience a substantial decrease in total revenues or profit margins, a potential breach of distribution agreements, a loss of customers, a negative effect on our reputation as a reliable supplier of plasma
derivative products or a substantial delay in our production and strategic growth plans.
The ability to increase plasma collections may be limited, our supply of plasma and plasma derivatives could be disrupted or the cost of plasma and plasma derivatives could increase
substantially, as a result of numerous factors, including a reduction in the donor pool, increased regulatory requirements, decreased number of plasma supply sources due to consolidation and new
indications for plasma-derived protein therapeutics, which could increase demand for plasma and plasma derivatives and lead to shortages.
We are also dependent on a number of suppliers who supply specialty ancillary products used in the production process, such as specific gels and filters. Each of these specialty ancillary products
is provided by a single, exclusive supplier. If these suppliers were unable to provide us with these specialty ancillary products, if our relationships with these suppliers deteriorate, or these suppliers’
operations are negatively affected by regulatory enforcement due to noncompliance, the manufacture and distribution of our products would be materially adversely affected, which would adversely affect
our sales and results of operations. See “—If we experience equipment difficulties or if the suppliers of our equipment or disposable goods fail to deliver key product components or supplies in a timely
manner, our manufacturing ability would be impaired and our product sales could suffer.”
In addition, regulatory requirements, including cGMP regulations, continually evolve. Failure of our plasma suppliers to adjust their operations to conform to new standards as established and
interpreted by applicable regulatory authorities would create a compliance risk that could impair our ability to sustain normal operations.
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In addition, if the purchase prices of the source plasma or plasma derivatives that we use to manufacture our proprietary products were to raise significantly, we may not be able to pass along
these increased plasma and plasma-derivative prices to our customers. Prices in many of our principal markets are subject to local regulation and certain pharmaceutical products, such as plasma-derived
protein therapeutics, are subject to price controls. Any inability to pass costs on to our customers due to these factors or others would reduce our profit margins. In addition, most of our competitors have
the ability to produce their own source plasma or plasma derivatives, and therefore their products' prices would not be impacted by such prices raise, and as a result any pricing changes by us in order to
pass higher costs on to our customers could render our products noncompetitive in certain territories.
We have been required to conduct post-approval clinical trials of Glassia and KamRAB as a condition to continuing marketing such products in the United States, and we may be required to conduct
post-approval clinical trials as a condition to licensing or distributing other products.
When a new product is approved, the FDA or other regulatory authorities may require post-approval clinical trials, sometimes called Phase IV clinical trials. For example, the FDA has required
that we conduct Phase IV clinical trials of Glassia, which began in 2015, and for KamRAB. Such Phase IV clinical trials are aimed at collecting additional safety data, such as the immune response in the
body of a human or animal, commonly referred to as immunogenicity, viral transmission, levels of the protein in the lung, or epithelial lining fluid, and certain efficacy endpoints requested by the FDA. If
the results of such trials are unfavorable and demonstrate a previously undetected risk or provide new information that puts patients at risk, or if we fail to complete such trials as instructed by the FDA,
this could result in receiving a warning letter from the FDA and the loss of the approval to market the product in the United States and other countries, or the imposition of restrictions, such as additional
labeling, with a resulting loss of sales. Other products we develop may face similar requirements, which would require additional resources and which may not be successful. We may also receive
approval, which is conditional on successful additional data or clinical development, and failure in such further development may require similar changes to our product label or result in revocation of our
marketing authorization.
The nature of producing plasma-derived protein therapeutics may prevent us from responding in a timely manner to market forces and effectively managing our production capacity.
The production of plasma-derived protein therapeutics is a lengthy and complex process. Our ability to match our production of plasma-derived protein therapeutics to market demand is
imprecise and may result in a failure to meet the market demand for our plasma-derived protein therapeutics or potentially in an oversupply of inventory. Failure to meet market demand for our plasma-
derived protein therapeutics may result in customers transitioning to available competitive products, resulting in a loss of segment share or distributor or customer confidence. In the event of an
oversupply in the market, we may be forced to lower the prices we charge for some of our plasma-derived protein therapeutics, record asset impairment charges or take other action which may adversely
affect our business, financial condition and results of operations.
Risks Related to Our Distribution Segment
Our Distribution segment is dependent on a few suppliers, and any disruption to our relationship with these suppliers, or their inability to supply us with the products we sell, in a timely manner, in
adequate quantities and/or at a reasonable cost, would have a material adverse effect on our business, financial condition and results of operations.
Sales of products supplied by Bio Products Laboratories Ltd. ("BPL") and Biotest A.G., which are sold in our Distribution segment, together represented approximately 17%, 24% and 33% of
our total revenues for the years ended December 31, 2017, 2016 and 2015, respectively. While we have distribution agreements with each of our suppliers, these agreements do not obligate these suppliers
to provide us with minimum amounts of our Distribution segment products. Purchases of our Distribution segment products from our suppliers are typically on a purchase order basis. We work closely
with our suppliers to develop annual forecasts, but these forecasts are not obligations or commitments. However, if we fail to submit purchase orders that meet our annual forecasts or if we fail to meet our
minimum purchase obligations, we could lose exclusivity or, in certain cases, the distribution agreement could be terminated.
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These suppliers may experience capacity constraints that result in their being unable to supply us with products in a timely manner, in adequate quantities and/or at a reasonable cost. Contributing
factors to supplier capacity constraints include, among other things, industry or customer demands in excess of machine capacity, labor shortages and changes in raw material flows. These suppliers may
also choose not to supply us with products at their discretion or raise prices to a level that would render our products noncompetitive. Any significant interruption in the supply of these products could
result in us being unable to meet the demands of our customers, which would have a material adverse effect on our business, financial condition and results of operations as a result of being required to
pay of fines or penalties, be subject to claims of reach of contract, loss of reputation or even termination of agreement.
Additionally, if our relationship with either deteriorated, our distribution sales could be adversely affected. If we fail to maintain our existing relationships with these suppliers, we could face
significant costs in finding a replacement supplier, and delays in establishing a relationship with a new supplier could lead to a decrease in our sales and a deterioration in our market share compared to
one or more of our competitors.
Sales in our Distribution segment rely primarily on our ability to win tender bids based on the price and availability of our products in annual public tender processes.
Sales in our Distribution segment rely primarily on our ability to win tender bids during the annual tender process in Israel, and our ability to win such bids may be materially adversely affected
by competitive conditions in such bid process. Our existing and new competitors may also have significantly greater financial resources than us, which they could use to promote their products and
business. Greater financial resources would also enable our competitors to substantially reduce the price of their products or services. If our competitors are able to offer prices lower than us, our ability to
win tender bids during the annual tender process will be materially affected, and could reduce our total revenues or decrease our profit margins.
Certain of our products in both segments have historically been subject to price fluctuations as a result of changes in the production capacity available in the industry, the availability and pricing
of plasma, development of competing products and the availability of alternative therapies. Higher prices for plasma-derived protein therapeutics have traditionally spurred increases in plasma production
and collection capacity, resulting over time in increased product supply and lower prices. As demand continues to grow, if plasma supply and manufacturing capacity do not commensurately expand,
prices tend to increase. Additionally, consolidation in plasma companies has led to a decrease in the number of plasma suppliers in the world, as either manufacturers of plasma-based pharmaceuticals
purchase plasma suppliers or plasma suppliers are shut down in response to the number of manufacturers of plasma-based pharmaceuticals decreasing, which may lead to increased prices. We may not be
able to pass along these increased plasma and plasma-derivative prices to our customers, which would reduce our profit margins.
Sales of our Distribution segment products are made through public tenders of Israeli hospitals and health maintenance organizations on an annual basis or in the private market based on detailing
activity made by our medical representatives. The prices we can offer, as well as the availability of products, are key factors in the tender process. If our suppliers in the Distribution segment cannot sell us
products at a competitive price or cannot guarantee sufficient quantities of products, we may lose the tenders.
Risk Related to Development, Regulatory Approval and Commercialization of Products Candidates
There can be no assurance that our current ongoing discussions with the FDA regarding the continued development of our Inhaled AAT for AATD product candidate will materialize and result in
FDA allowing our pivotal clinical study to proceed under an IND
We completed a Phase II clinical trial of our Inhaled AAT for AATD in the United States, which met its primary endpoint. However, when we presented the data from the European Phase II/III
study to the FDA in April 2016, the FDA expressed concerns and questions about that data, primarily related to the safety and efficacy of Inhaled AAT for the treatment of AATD and the risk/benefit
balance to patients based on that data. The FDA’s questions and concerns need to be resolved before the agency will allow us to proceed with additional clinical development of Inhaled AAT in the United
States. See also“—We may not be able to commercialize our product candidates in development for numerous reasons.” In order to address the FDA’s concerns and questions, in April 2017, we submitted
to the agency the results of the U.S. Phase II data together with a proposed Phase III synopsis. The FDA then provided us with guidance for further development of the synopsis and requested that we
submit a complete proposed study protocol for the next phase prior to enabling us to continue clinical development and initiate the Phase III study in the United States. In July 2017, we submitted a full
study protocol, and in August 2017, in response to the study protocol and previous submission, the FDA issued a letter stating that it continues to have concerns and questions about the safety and efficacy
of the Inhaled AAT for AATD. We have since, commenced discussions with the FDA and revised the protocol based on its feedback as well as are in the process of providing additional requested
information to the agency. We will need to receive authorization from the FDA in order to proceed with the clinical development of Inhaled AAT in the United States, including our proposed Phase III
clinical trial. However, the FDA may decide that the risk/benefit balance to patients based on the comprehensive data we plan to submit to the FDA does not ease the FDA’s concerns and accordingly, the
FDA will not approve the IND for our planned Phase III study in the United States of our Inhaled AAT for AATD product candidate.
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We may not be able to commercialize our product candidates in development for numerous reasons.
Due to Clinical and Preclinical Related Reasons:
Before obtaining regulatory approval for the sale of our product candidates, including Inhaled AAT for AATD, or for the marketing of existing products for new indications, we must conduct, at
our own expense, extensive preclinical tests to demonstrate the safety of our product candidates in animals and clinical trials to demonstrate the safety and efficacy of our product candidates in humans.
We cannot predict how long the approval processes of the FDA, the EMA, the regulatory authorities in Israel or any other applicable regulatory authority or agency for any of our product candidates will
take or whether any such approvals ultimately will be granted. The FDA, the EMA, the regulatory authorities in Israel and other regulatory agencies have substantial discretion in the relevant drug
approval process over which they have authority, and positive results in preclinical testing or early phases of clinical studies offer no assurance of success in later phases of the approval process. The
approval process varies from country to country and the requirements governing the conduct of clinical trials, product manufacturing, product licensing, pricing and reimbursement vary greatly from
country to country.
Preclinical and clinical testing is expensive, is difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more of our clinical trials can
occur at any stage of testing. For example, the Phase II/III clinical trial in Europe for Inhaled AAT for AATD did not meet its primary or secondary endpoints and we subsequently withdrew the MAA in
Europe for our Inhaled AAT for AATD.
We have experienced other unforeseen events that have delayed our ability to receive regulatory approval for certain of our product candidates, and may in the future experience similar or other
unforeseen events during, or as a result of, preclinical testing or the clinical trial process that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates,
including that:
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delays may occur in obtaining our clinical materials;
our preclinical tests or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional preclinical testing or clinical
trials or to abandon strategic projects;
the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower or more difficult than we anticipate, or participants
may withdraw from our clinical trials at higher rates than we anticipate;
delays may occur in reaching agreement on acceptable clinical trial agreement terms with prospective sites or obtaining institutional review board approval;
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our strategic partners may not achieve their clinical development goals and/or comply with their relevant regulatory requirements;
we may be forced to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks or if any participant experiences an unexpected serious
adverse event;
regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
regulators may not authorize us to commence or conduct a clinical trial within a country or at a prospective trial site, or according to the clinical trial outline we propose;
undetected or concealed fraudulent activity by a clinical researcher, if discovered, could preclude the submission of clinical data prepared by that researcher, lead to the suspension or
substantive scientific review of one or more of our marketing applications by regulatory agencies, and result in the recall of any approved product distributed pursuant to data determined
to be fraudulent;
the cost of our clinical and preclinical trials may be greater than we anticipate;
an audit of preclinical tests or clinical studies by the FDA, the EMA, the regulatory authorities in Israel or other regulatory authorities may reveal noncompliance with applicable
regulations, which could lead to disqualification of the results of such studies and the need to perform additional tests and studies; and
our product candidates may not achieve the desired clinical benefits, or may cause undesirable side effects, or the product candidates may have other unexpected characteristics.
If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we contemplate, if we are unable to successfully complete our clinical trials or
other testing, if the results of these trials or tests are not positive or are only modestly positive or if safety concerns arise, we may:
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be delayed in obtaining regulatory or marketing approval for our product candidates;
be unable to obtain regulatory and marketing approval;
decide to halt the clinical trial or other testing;
be required to conduct additional trials under a conditional approval;
be unable to obtain reimbursement for our products in all or some countries;
only obtain approval for indications that are not as broad as we initially intend;
have the product removed from the market after obtaining marketing approval from the FDA, the EMA, the regulatory authorities in Israel or other regulatory authorities; and
be delayed in, or prevented from, the receipt of clinical milestone payments from our strategic partners.
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Our product development costs will also increase if we experience delays in testing or approvals. There can be no assurance that any preclinical test or clinical trial will begin as planned, not need
to be restructured or be completed on schedule, if at all. Because we generally apply for patent protection for our product candidates during the development stage, significant preclinical or clinical trial
delays also could lead to a shorter patent protection period during which we may have the exclusive right to commercialize our product candidates, if approved, or could allow our competitors to bring
products to market before we do, impairing our ability to commercialize our products or product candidates. For example, in the past, we have experienced delays in the commencement of clinical trials,
such as a delay in patient enrollment for our clinical trials in Europe for Inhaled AAT for AATD and a delay in receiving approval for the commencement of Phase II trials in the United States for Inhaled
AAT for AATD until further preclinical testing results were submitted. Furthermore, we will need to address the questions and concerns that the FDA expressed relating to the data from the European
Phase II/III study, primarily related to the safety and efficacy and the risk/benefit balance to patients based on that data, before the FDA will allow us to proceed with additional clinical development of
Inhaled AAT in the United States, including our planned Phase III pivotal study.
Pre-clinical studies, including studies of our product candidates in animal models of disease, may not accurately predict the result of human clinical trials of those product candidates. In
particular, new indications for our AAT products that are entering into Phase I and II clinical trials may be found not to be safe and/or efficacious when studied further in Phase III trials. To satisfy FDA or
other applicable regulatory approval standards for the commercial sale of our product candidates, we must demonstrate in adequate and controlled clinical trials that our product candidates are safe and
effective. Success in early clinical trials, including Phase II trials, does not ensure that later clinical trials will be successful. Initial results from Phase I and II clinical trials also may not be confirmed by
later analysis or subsequent larger clinical trials. A number of companies in the pharmaceutical industry, including us, have suffered significant setbacks in advanced clinical trials, even after obtaining
promising results in earlier clinical trials.
Due to Regulatory Related Reasons:
Even if preclinical and clinical trials are successful, we still may be unable to commercialize a product because of difficulties in obtaining regulatory approval for its production process or
problems in scaling that process to commercial production. In addition, the regulatory requirements for product approval may not be explicit, may evolve over time and may diverge among jurisdictions
and our third-party contractors, such as contract research organizations, may fail to comply with regulatory requirements or meet their contractual obligations to us.
Due to Commercial Reasons:
Even if we are successful in our development and regulatory strategies, we cannot provide assurance that any products we may seek to develop or are currently developing, such as Inhaled AAT
for AATD, will ever be successfully commercialized. We may not be able to successfully address patient needs, persuade physicians and payors of the benefit of our product, and lead to usage and
reimbursement. If such products are not eventually commercialized, the significant expense and lack of associated revenue could materially adversely affect our business.
We may not be able to successfully build and implement a commercial organization or commercialization program, with or without collaborating partners. The scale-up from research and
development to commercialization requires significant time, resources, and expertise, which will rely, to a large extent, on third parties for assistance to help us in our efforts. Such assistance includes, but
is not limited to, persuading physicians and payors of the benefit of our product to lead to utilization and reimbursement, developing a healthcare compliance program, and complying with post-marketing
regulatory requirements.
If we are unable to successfully introduce new products and indications or fail to keep pace with advances in technology, our business, financial condition and results of operations may be adversely
affected.
We operate in highly innovative businesses. We currently rely on sales of Glassia for the treatment of AATD for a significant portion of our total revenues. However, our continued growth
depends in large part on our ability to develop and obtain regulatory approvals of new products, new enhancements and/or new indications for our products and product candidates. Obtaining regulatory
approval in any jurisdiction, including from the EMA or the FDA, involves significant uncertainty and may be time consuming and require significant expenditures. See “—Research and development
efforts invested in our pipeline of specialty and other products may not achieve expected results.” We have experienced delays at various stages of obtaining regulatory approval in the past, and failure to
obtain regulatory approval of the Inhaled AAT for AATD product or of any of our other product candidates or additional indications in a timely manner or at all would materially adversely impact our
business prospects. For example, the Phase II/III clinical trial in Europe for Inhaled AAT for AATD did not meet its primary or other pre-defined endpoints and, following our discussions with the EMA in
regards to the study results, in June 2017, we withdrew the MAA in Europe for our Inhaled AAT for AATD. When we presented the data from the European Phase II/III study to the FDA, the agency
expressed concerns and questions about that data, primarily related to the safety and efficacy of our Inhaled AAT for AATD and the risk/benefit balance to patients based on that data. Those questions and
concerns will need to be resolved before the FDA will allow us to proceed with additional clinical development of Inhaled AAT in the United States, including our planned Phase III pivotal study. See also
“—We may not be able to commercialize our product candidates in development for numerous reasons.”
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The development of innovative products and technologies that improve efficacy, safety, patients’ and clinicians’ ease of use and cost-effectiveness, involve significant technical and business
risks. The success of new product offerings will depend on many factors, including our ability to properly anticipate and satisfy customer needs, adapt to new technologies, obtain regulatory approvals on
a timely basis, demonstrate satisfactory clinical results, manufacture products in an economic and timely manner, engage qualified distributors for different territories and establish our sales force to sell
our products, and differentiate our products from those of our competitors. If we cannot successfully introduce new products, adapt to changing technologies or anticipate changes in our current and
potential customers’ requirements, our products may become obsolete and our business could suffer.
Research and development efforts invested in our pipeline of specialty and other products may not achieve expected results.
We must invest increasingly significant resources to develop specialty products through our own efforts and through collaborations with third parties in the form of partnerships or otherwise. The
development of specialty pharmaceutical products involves high-level processes and expertise and carries a significant risk of failure. For example, the average time from the pre-clinical phase to the
commercial launch of a specialty pharmaceutical product can be 15 years or longer, and involves multiple stages: not only intensive preclinical and clinical testing, but also highly complex, lengthy and
expensive regulatory approval processes, which can vary from country to country. The longer it takes to develop a pharmaceutical product, the longer it may take for us to recover our development costs
and generate profits, and, depending on various factors, we may not be able to ever recover such costs or generate profits.
During each stage of development, we may encounter obstacles that delay the development process and increase expenses, leading to significant risks that we will not achieve our goals and may
be forced to abandon a potential product in which we have invested substantial amounts of time and money. These obstacles may include the following: preclinical-study failures; difficulty in enrolling
patients in clinical trials; delays in completing formulation and other work needed to support an application for approval; adverse reactions or other safety concerns arising during clinical testing;
insufficient clinical trial data to support the safety or efficacy of a product candidate; other failures to obtain, or delays in obtaining, the required regulatory approvals for a product candidate or the
facilities in which a product candidate is manufactured; regulatory restrictions which may delay or block market penetration and the failure to obtain sufficient intellectual property rights for our products.
Accordingly, there can be no assurance that the continued development of our IV AAT (Glassia) for the treatment of T1D, GvHD and lung transplantation rejection will be successful and will
result in an FDA and/or EMA approvable indication.
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Because of the amount of time and expense required to be invested in augmenting our pipeline of specialty and other products, including the unique know-how which may be required for such
purpose, we may seek partnerships or joint ventures with third parties from time to time, and consequently face the risk that some or all of these third parties may fail to perform their obligations, or that
the resulting arrangement may fail to produce the levels of success that we are relying on to meet our revenue and profit goals.
We rely on third parties to conduct our preclinical and clinical trials. The failure of these third parties to successfully carry out their contractual duties or meet expected deadlines could substantially
harm our business because we may not obtain regulatory approval for, or commercialize, our product candidates in a timely manner or at all.
We rely upon third-party contractors, such as university researchers, physicians and contract research organizations (“CROs”), to conduct, monitor and manage data for our current and future
preclinical and clinical programs. We expect to continue to rely on these parties for execution of our preclinical and clinical trials, and we control only certain aspects of their activities. Nevertheless, we
are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on such third-party contractors
does not relieve us of our regulatory responsibilities. With respect to clinical trials, we and our CROs are required to comply with current Good Clinical Practices ("GCP"), which are regulations and
guidelines enforced by the FDA, the EMA and comparable foreign regulatory authorities for all of our products in clinical development. Regulatory authorities enforce these GCP through periodic
inspections of trial sponsors, principal investigators and trial sites. If we or any of our CROs fail to comply with applicable GCP, the clinical data generated in our clinical trials may be deemed unreliable
and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a
given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP requirements.
These third-party contractors are not our employees, we cannot effectively control whether or not they devote sufficient time and resources to our ongoing clinical, nonclinical and preclinical
programs, and except for remedies available to us under our agreements with such third-party contractors, we may be unable to recover losses that result from any inadequate work on such programs. If
such third-party contractors do not successfully carry out their contractual duties or obligations or meet expected deadlines or if the quality or accuracy of the data they obtain is compromised due to the
failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our development efforts and clinical trials may be extended, delayed or terminated and we may not be able to obtain
regulatory approval for or successfully commercialize our product candidates. As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs
could increase and our ability to generate revenues could be delayed. To the extent we are unable to successfully identify and manage the performance of such third-party contractors in the future, our
business may be adversely affected.
We may not obtain orphan drug status for our products, or we may lose orphan drug designations, which would have a material adverse effect on our business.
One of the incentives provided by an orphan drug designation is market exclusivity for seven years in the United States and ten years in the European Union for the first product in a class
approved for the treatment of a rare disease. Although several of our products and product candidates, including Inhaled AAT for AATD, have been granted the designation of an orphan drug, we may not
be the first product licensed for the treatment of particular rare diseases in the future or our approved indication may vary from that subject to the orphan designation. In such cases, then with limited
exception, we would not be able to take advantage of market exclusivity and instead another sponsor would receive such exclusivity.
Additionally, although the marketing exclusivity of an orphan drug would prevent other sponsors from obtaining approval of the same drug compound for the same indication, such exclusivity
would not apply in the case that a subsequent sponsor could demonstrate clinical superiority or a market shortage occurs and would not prevent other sponsors from obtaining approval of the same
compound for other indications or the use of other types of drugs for the same use as the orphan drug. In the event we are unable to fill demand for any orphan drug, it is possible that the FDA or the EMA
may view such unmet demand as a market shortage, which could impact our market exclusivity.
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The FDA and the EMA may also, in the future, revisit any orphan drug designation that they have respectively conferred upon a drug and retain the ability to withdraw the relevant designation at
any time. Additionally, the U.S. Congress has considered, and may consider in the future, legislation that would restrict the duration or scope of the market exclusivity of an orphan drug, and, thus, we
cannot be sure that the benefits to us of the existing statute in the United States will remain in effect.
If we lose our orphan drug designations or fail to obtain such designations for our new products and product candidates, our ability to successfully market our products could be significantly
affected, resulting in a material adverse effect on our business and results of operations.
The commercial success of the products that we may develop, if any, will depend upon the degree of market acceptance by physicians, patients, healthcare payors, opinion leaders, patients’
organizations and others in the medical community that any such product obtains.
Any products that we bring to the market may not gain market acceptance by physicians, patients, healthcare payors, opinion leaders, patients’ organizations and others in the medical community.
If these products do not achieve an adequate level of acceptance, we may not generate material product revenue and we may not sustain profitability. The degree of market acceptance of our product
candidates, if approved for commercial sale, will depend on a number of factors, some of which are beyond our control, including:
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the prevalence and severity of any side effects;
the efficacy, potential advantages and timing of introduction to the market of alternative treatments;
our ability to offer our product candidates for sale at competitive prices;
relative convenience and ease of administration of our products;
the willingness of physicians to prescribe our products;
the willingness of patients to use our products;
the strength of marketing and distribution support; and
third-party coverage or reimbursement.
If we are not successful in achieving market acceptance for any new products that we have developed and that have been approved for commercial sale, we may be unable to recover the large
investment we will have made and have committed ourselves to making in research and development efforts and our growth strategy will be adversely affected.
Each inhaled formulation of AAT, including Inhaled AAT for AATD, is being developed with a specific nebulizer produced by PARI, and the occurrence of an adverse market event or PARI’s non-
compliance with its obligations would have a material adverse effect on the commercialization of any inhaled formulation of AAT.
We are dependent upon PARI GmbH ("PARI") for the commercialization of any inhaled formulation of AAT, including our second generation AATD product, Inhaled AAT for AATD. We have
an agreement with PARI, pursuant to which it is required to obtain the appropriate clearance to market PARI’s eFlow device, which is a device required for the administration of inhaled formulation of
AAT, from the EMA and FDA for use with Inhaled AAT for AATD. See “Item 4. Information on the Company — Strategic Partnerships — PARI.” Failure of PARI to achieve these authorizations will
have a material adverse effect on the commercialization of any inhaled formulation of AAT, including Inhaled AAT for AATD, which would harm our growth strategy.
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Additionally, pursuant to the agreement, PARI is obligated to manufacture and supply all of the market demand for the eFlow device for use in conjunction with any inhaled formulation of AAT
and we are required to purchase all of our volume requirements from PARI. Any event that permanently, or for an extended period, prevents PARI from supplying the required quantity of devices would
have an adverse effect on the commercialization of any inhaled formulation of AAT, including Inhaled AAT for AATD.
Risks Related to Our Financial Position and Capital Resources
We have incurred significant losses since our inception and while we were profitable in the year ended December 31, 2017 we may continue to incur losses in the future and thus may never achieve
sustained profitability.
As of December 31, 2017, our cash and cash equivalents and short-term investments were $43 million. Since inception, we have incurred significant operating losses. Our net profit was $6.9
million for the year ended December 31, 2017, while for the years ended December 31, 2016 and 2015 we incurred net losses of $6.7 million and $11.3 million respectively. As of December 31, 2017, we
had an accumulated deficit of $104.6 million. There can be no assurance that we could continue to generate profitability in future years.
Our business requires substantial capital, including potential investments in large capital projects, to operate and grow and to achieve our strategy of realizing increased operating leverage.
In order to obtain FDA, EMA and other regulatory approvals for product candidates and new indications for existing products, we may be required to enhance the facilities in which and processes
by which we manufacture existing products, to develop new product delivery mechanisms for existing products, to develop innovative product additions and to conduct clinical trials. We face a number of
obstacles that we will need to overcome in order to achieve our operating goals, including but not limited to the successful development of experimental products for use in clinical trials, the design of
clinical study protocols acceptable to the FDA, the EMA and other regulatory authorities, the successful outcome of clinical trials, scaling our manufacturing processes to produce commercial quantities
or successfully transition technology, obtaining FDA, EMA and other regulatory approvals of the resulting products or processes and successfully marketing an approved or new product with applicable
new processes. To finance these various activities, we may need to incur future debt or issue additional equity. We may not be able to structure our debt obligations on favorable economic terms and any
offering of additional equity would result in a dilution of the equity interests of our current shareholders. A failure to fund these activities may harm our growth strategy, competitive position, quality
compliance and financial condition.
In addition, any enhancements to our manufacturing facilities necessary to obtain FDA or EMA approval for product candidates or new indications for existing products could require large
capital projects. We may also undertake such capital projects in order to maintain compliance with cGMP or expand capacity. Capital projects of this magnitude involve technology and project
management risks. Technologies that have worked well in a laboratory or in a pilot plant may cost more or not perform as well, or at all, in full scale operations. Projects may run over budget or be
delayed. We cannot be certain that any such project will be completed in a timely manner or that we will maintain our compliance with cGMP, and we may need to spend additional amounts to achieve
compliance. Additionally, by the time multi-year projects are completed, market conditions may differ significantly from our initial assumptions regarding competitors, customer demand, alternative
therapies, reimbursement and public policy, and as a result capital returns may not be realized. In addition, to fund large capital projects, we may similarly need to incur future debt or issue additional
dilutive equity. A failure to fund these activities may harm our growth strategy, competitive position, quality compliance and financial condition.
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Our current working capital may not be sufficient to complete our research and development with respect to any or all of our pipeline products or to commercialize our products.
As of December 31, 2017, we had cash and short-term investments of approximately $43.0 million, compared to cash and short-term investments of approximately $28.6 million as of December
31, 2016. Historically, we have funded our operations primarily through cash flow from operations (including sales of our approved proprietary products and sales of distributional products), payments
received in connection with strategic partnerships (including milestone payments from collaborating agreements), sales of ordinary shares (including our 2005 initial public offering on the Tel-Aviv Stock
Exchange, our 2013 initial public offering on NASDAQ and our ordinary share offering which closed in August 2017), and the issuance of convertible debentures, our ordinary shares and warrants to
purchase our ordinary shares. We plan to fund our future operations through continued sale and distribution of our proprietary and distributed products, commercialization and or out-licensing of our
pipeline product candidates, and raising additional capital through the sale of equity or debt. These amounts may not be sufficient to complete the research and development of all of our candidates, and
there can be no assurances of the financial success of our commercialization activities or our ability to access the equity and debt capital markets on terms acceptable to us, if at all. To the extent we are
unable to fund our research and development, our future product development activities could be materially adversely affected.
Raising additional capital would cause dilution to our existing shareholders, and may restrict our operations or require us to relinquish rights.
On November 28, 2016, we filed a registration statement on Form F-3 with the U.S. Securities and Exchange Commission (“SEC”) utilizing a “shelf” registration process. Under this shelf
registration process, we may offer from time to time up to an aggregate of $100,000,000 of our ordinary shares in one or more offerings. Pursuant to such shelf registration statement, in August 2017, we
issued an aggregate of 3,833,334 ordinary shares in an underwritten public offering (including the exercise of the over-allotment option). To the extent that we raise additional funds through the sale of
equity or securities that are convertible into or exchangeable for, or that represent the right to receive, ordinary shares or substantially similar securities, your ownership interest will be diluted, and the
terms may include liquidation or other preferences that adversely affect your rights as a shareholder. Debt financing, if available, would result in increased fixed payment obligations and may involve
agreements that include covenants limiting or restricting our ability to take specific actions such as incurring debt, making capital expenditures or declaring dividends. If we raise additional funds through
collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates, or grant licenses
on terms that are not favorable to us.
Risks Related to Our Business and Industry
Product liability claims or product recalls involving our products, or products we distribute, could have a material adverse effect on our business.
Our business exposes us to the risk of product liability claims that are inherent in the manufacturing, distribution and sale of plasma-derived therapeutic protein products and other drug products.
We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and an even greater risk when we commercially sell any products, including
those manufactured by others that we distribute in Israel. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, or if the indemnities we have
negotiated do not adequately cover losses, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
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decreased demand for our plasma-derived protein therapeutics and any product candidates that we may develop;
injury to our reputation;
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difficulties in recruitment of new participants to our future clinical trials and withdrawal of current clinical trial participants;
costs to defend the related litigation;
substantial monetary awards to trial participants or patients;
difficulties in finding distributors for our products;
difficulties in entering into strategic partnerships with third parties;
diversion of management’s attention;
loss of revenue;
the inability to commercialize any products that we may develop; and
higher insurance premiums.
Plasma is biological matter that is capable of transmitting viruses and pathogens, whether known or unknown. Therefore, plasma derivative products, if not properly tested, inactivated, processed,
manufactured, stored and transported, could cause serious disease and possibly death to the patient. Further, even when such steps are properly effected, viral and other infections may escape detection
using current testing methods and may not be susceptible to inactivation methods. Any transmission of disease through the use of one of our products or third-party products sold by us could result in
claims against us by or on behalf of persons allegedly infected by such products.
In addition, we sell and distribute third-party products in Israel, and the laws of Israel could also expose us to product liability claims for those products. Furthermore, the presence of a defect (or
a suspicion of a defect) in a product could require us to carry out a recall of such product. A product liability claim or a product recall could result in substantial financial losses, negative reputational
repercussions, loss of business and an inability to retain customers. Although we maintain insurance for certain types of losses, claims made against our insurance policies could exceed our limits of
coverage or be outside our scope of coverage. Additionally, as product liability insurance is expensive and can be difficult to obtain, a product liability claim could increase our required premiums or
otherwise decrease our access to product liability insurance on acceptable terms. In turn, we may not be able to maintain insurance coverage at a reasonable cost and may not be able to obtain insurance
coverage that will be adequate to satisfy liabilities that may arise.
Regulatory approval for our products is limited by the FDA and similar authorities in other jurisdictions to those specific indications and conditions for which clinical safety and efficacy have been
demonstrated, and the prescription or promotion of off-label uses could adversely affect our business.
Any regulatory approval of our products is limited to those specific diseases and indications for which our products have been deemed safe and effective by the FDA or similar authorities in other
jurisdictions. In addition to the regulatory approval required for new formulations, any new indication for an approved product also requires regulatory approval. Once we produce a plasma-derived
protein therapeutic, we rely on physicians to prescribe and administer it as the product label directs and for the indications described on the labeling. To the extent any off-label (i.e., unapproved) uses and
departures from the approved administration directions become pervasive and produce results such as reduced efficacy or other adverse effects, the reputation of our products in the marketplace may
suffer. In addition, off-label uses may cause a decline in our revenues or potential revenues, to the extent that there is a difference between the prices of our product for different indications.
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Furthermore, while physicians may choose to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those approved by regulatory authorities, our
ability to promote the products is limited to those indications that are specifically approved by the FDA or other regulators. Although regulatory authorities generally do not regulate the behavior of
physicians, they do restrict communications by companies on the subject of off-label use. If our promotional activities fail to comply with these regulations or guidelines, we may be subject to warnings
from, or enforcement action by, these authorities. In addition, failure to follow FDA rules and guidelines relating to promotion and advertising can lead to other negative consequences that could hurt us,
such as the suspension or withdrawal of an approved product from the market, enforcement letters, and corrective actions. Other regulatory authorities may impose separately penalties including, but not
limited to, fines, disgorgement of money, operating restrictions, or criminal prosecution.
The loss of one or more of our key employees could harm our business.
We depend on the continued service and performance of our key employees, including Amir London, our Chief Executive Officer and our other senior management. We have entered into
employment agreements with all of our senior management, including Mr. London, and other key employees. Either party, however, can terminate these agreements for any reason. The loss of key
members of our executive management team could disrupt our operations or product development and have an adverse effect on our ability to grow our business.
Our ability to attract, recruit, retain and develop qualified employees is critical to our success and growth.
We compete in a market that involves rapidly changing technological and regulatory developments that require a wide ranging set of expertise and intellectual capital. In order for us to
successfully compete and grow, we must attract, recruit, retain and develop the necessary personnel who can provide the needed expertise across the entire spectrum of our intellectual capital needs. While
we have a number of our key personnel who have substantial experience with our operations, we must also develop and exercise our personnel to provide succession plans capable of maintaining
continuity in the midst of the inevitable unpredictability of human capital. However, the market for qualified personnel is competitive, and we may not succeed in recruiting additional experienced or
professional personnel, retaining current personnel or effectively replacing current personnel who depart with qualified or effective successors. Many of the companies with which we compete for
experienced personnel have greater resources than us.
Our effort to retain and develop personnel may also result in significant additional expenses, which could adversely affect our profitability. There can be no assurance that qualified employees
will continue to be employed or that we will be able to attract and retain qualified personnel in the future. Failure to retain or attract qualified personnel could have a material adverse effect on our
business, financial condition and results of operations.
We are subject to risks associated with doing business globally.
Our operations are subject to risks inherent to conducting business globally and under the laws, regulations and customs of various jurisdictions and geographies. These risks include fluctuations
in currency exchange rates, changes in exchange controls, loss of business in government and public tenders that are held annually in many cases, nationalization, expropriation and other governmental
actions, availability of raw materials, changes in taxation, importation limitations, export control restrictions, changes in or violations of applicable laws, including the U.S. Foreign Corrupt Practices Act
(“FCPA”), the U.K. Bribery Act of 2010, pricing restrictions, economic and political instability, disputes between countries, diminished or insufficient protection of intellectual property, and disruption or
destruction of operations in a significant geographic region regardless of cause, including war, terrorism, riot, civil insurrection or social unrest. Failure to comply with, or material changes to, the laws
and regulations that affect our global operations could have an adverse effect on our business, financial condition or results of operations.
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Laws and regulations governing the conduct of international operations may negatively impact our development, manufacture and sale of products outside of the United States and require us to
develop and implement costly compliance programs.
We must comply with numerous laws and regulations in Israel and in each of the other jurisdictions in which we operate or plan to operate. The creation and implementation of any required
compliance programs is costly, and the programs are often difficult to enforce, particularly where we must rely on third parties.
For example, the FCPA prohibits any U.S. individual or business from paying, offering, authorizing payment or offering anything of value, directly or indirectly, to any foreign official, political
party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also requires companies
whose securities are listed in the United States to comply with certain accounting provisions. For example, such companies must maintain books and records that accurately and fairly reflect all
transactions of the company, including international subsidiaries, and devise and maintain an adequate system of internal accounting controls for international operations. The anti-bribery provisions of the
FCPA are enforced primarily by the U.S. Department of Justice, and the SEC is involved with enforcement of the books and records provisions of the FCPA.
Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the
pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in
connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.
The failure to comply with laws governing international business practices may result in substantial penalties, including suspension or debarment from government contracting. Violation of the
FCPA can result in significant civil and criminal penalties. Indictment alone under the FCPA can lead to suspension of the right to do business with the U.S. government until the pending claims are
resolved. Conviction of a violation of the FCPA can result in long-term disqualification as a government contractor. The termination of a government contract or relationship as a result of our failure to
satisfy any of our obligations under laws governing international business practices would have a negative impact on our operations and harm our reputation and ability to procure government contracts.
Additionally, the SEC also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions.
We are subject to foreign currency exchange risk.
We receive payment for our sales and make payments for resources in a number of different currencies. While our sales and expenses are primarily denominated in U.S. dollars, our financial
results may be adversely affected by fluctuations in currency exchange rates as a portion of our sales and expenses are denominated in other currencies, including the NIS and the Euro. Market volatility
and currency fluctuations may limit our ability to cost-effectively hedge against our foreign currency exposure and, in addition, our ability to hedge our exposure to currency fluctuations in certain
emerging markets may be limited. Hedging strategies may not eliminate our exposure to foreign exchange rate fluctuations and may involve costs and risks of their own, such as devotion of management
time, external costs to implement the strategies and potential accounting implications. Foreign currency fluctuations, independent of the performance of our underlying business, could lead to materially
adverse results or could lead to positive results that are not repeated in future periods.
Events in global credit markets may impact our ability to obtain financing or increase the cost of future financing, including interest rate fluctuations based on macroeconomic conditions that are
beyond our control.
During periods of volatility and disruption in the U.S., European, or global credit markets, obtaining additional or replacement financing may be more difficult and the cost of issuing new debt
could be higher than the costs we incur under our current debt. The higher cost of new debt may limit our ability to have cash on hand for working capital, capital expenditures and acquisitions on terms
that are acceptable to us.
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Developments in the economy may adversely impact our business.
Our operating and financial performance may be adversely affected by a variety of factors that influence the general economy in the United States, Europe and worldwide, including global and
local economic slowdowns, challenges faced banks and the health of markets for the sovereign debt. Many of our largest markets, including the United States and Europe, previously experienced dramatic
declines in the housing market, high levels of unemployment and underemployment, and reduced earnings, or, in some cases, losses, for businesses across many industries, with reduced investments in
growth.
A recessionary economic environment may adversely affect demand for our plasma-derived protein therapeutics. As a result of job losses, patients in the U.S. may lose medical insurance and be
unable to purchase needed medical products or may be unable to pay their share of deductibles or co-payments. Hospitals may steer patients adversely affected by the economy to less costly therapies,
resulting in a reduction in demand, or demand may shift to public health hospitals, which purchase our products at a lower government price. A recessionary economic environment may also lead to price
pressure for reimbursement of new drugs, which may adversely affect the demand for our future plasma-derived protein therapeutics.
If our manufacturing facility in Beit Kama, Israel were to suffer a serious accident, contamination, force majeure event materially affecting our ability to operate and produce saleable plasma-
derived protein therapeutics, all of our manufacturing capacity could be shut down for an extended period.
We rely on a single manufacturing facility in Beit Kama, which is located in southern Israel, approximately 20 miles from the Gaza Strip. All of our revenues in our Proprietary Products segment
are derived from products manufactured at this facility and some of the products that are imported by us under our Distribution segment, are packed and stored in this manufacturing facility. If this facility
were to suffer an accident or a force majeure event such as war, terrorist attack, earthquake, major fire or explosion, major equipment failure or power failure lasting beyond the capabilities of our backup
generators or similar event, or contamination, our revenues would be materially adversely affected. In this situation, our manufacturing capacity could be shut down for an extended period, we could
experience a loss of raw materials, work in process or finished goods and imported products inventory and our ability to operate our business would be harmed. In addition, in any such event, the
reconstruction of our manufacturing facility and storage facilities, and the regulatory approval of the new facilities could be time-consuming. During this period, we would be unable to manufacture our
plasma-derived protein therapeutics.
Our insurance against property damage and business interruption insurance may be insufficient to mitigate the losses from any such accident or force majeure event. We may also be unable to
recover the value of the lost plasma or work-in-process inventories, as well as the sales opportunities from the products we would be unable to produce or distribute, or the loss of customers during such
period.
Failure to adequately or timely adapt our manufacturing capacity to match changes in demand for our manufactured products may have a material adverse effect on our business.
As our product offerings in our Proprietary Products segment is predicted to increase until 2020, until such date we will be required to produce in higher volumes compare to previous years. A
failure to increase our manufacturing volume as needed may lead to an inability to supply products, may have an adverse effect on our business and could cause substantial harm to our business reputation
and result in breach of our sales agreements and the loss of future customers and orders.
After 2020, Shire has no obligation to purchase a minimum amount of Glassia, and we estimate that Shire will begin selling Glassia produced in its own manufacturing facility as early as 2021
and paying us royalties. As Shire transitions to producing Glassia in its own facilities, we will incur a substantial reduction in revenues (as well as costs of goods sold) driven by the reduction in Glassia
manufacturing. Our revenues and our operating results may be adversely impacted if we are unable to reduce fixed costs relating to our manufacturing facility in line with any reduction in demand.
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If we experience equipment difficulties or if the suppliers of our equipment or disposable goods fail to deliver key product components or supplies in a timely manner, our manufacturing ability
would be impaired and our product sales could suffer.
For certain equipment and supplies, we depend on a limited number of companies that supply and maintain our equipment and provide supplies such as chromatography resins, filter media, glass
bottles and stoppers used in the manufacture of our plasma-derived protein therapeutics. If our equipment were to malfunction, or if our suppliers stop manufacturing or supplying such machinery,
equipment or any key component parts, the repair or replacement of the machinery may require substantial time and cost, and could disrupt our production and other operations. Alternative sources for
key component parts or disposable goods may not be immediately available. In addition, any new equipment or change in supplied materials may require revalidation by us or review and approval by the
FDA, the EMA, the regulatory authorities in Israel or other regulatory authorities, which may be time-consuming and require additional capital and other resources. We may not be able to find an adequate
alternative supplier in a reasonable time period, or on commercially acceptable terms, if at all. As a result, shipments of affected products may be limited or delayed. Our inability to obtain our key source
supplies for the manufacture of products may require us to delay shipments of products, harm customer relationships and force us to curtail operations.
If our shipping or distribution channels were to become inaccessible due to an accident, act of terrorism, strike or any other force majeure event, our supply, production and distribution processes
could be disrupted.
Our plasma raw materials must be transported at a temperature of -20 degrees Celsius (-4 degrees Fahrenheit) to ensure the preservation of their proteins. Not all shipping or distribution channels
are equipped to transport plasma at these temperatures. If any of our shipping or distribution channels become inaccessible because of a serious accident, act of terrorism, strike or any other force majeure
event, we may experience disruptions in our continued supply of plasma and other raw materials, delays in our production process or a reduction in our ability to distribute our plasma-derived protein
therapeutics to our customers.
A breakdown in our information technology (IT) systems could result in a significant disruption to our business.
Our operations are highly dependent on our information technology (IT) systems. If we were to suffer a breakdown in our systems, storage, distribution or tracing, we could experience significant
disruptions affecting all our areas of activity, including our manufacturing, research, accounting and billing processes and potentially cause disruptions to our manufacturing process for products currently
in production. We may also suffer from partial loss of information and data due to such disruption.
Our business and operations would suffer in the event of computer system failures, cyber-attacks on our systems or deficiency in our cyber security measures.
Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, unauthorized
access, malware, natural disasters, fire, terrorism, war and telecommunication, electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization,
or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign
governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. To the extent that any
disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability due to lost revenues
resulting from the unauthorized use or theft of sensitive business information, remediation costs, and litigation risks including potential regulatory action by governmental authorities. In addition, any
such disruption, security breach or other incident could delay the further development of our future product candidates due to theft or corruption of our proprietary data or other loss of information. Our
business and operations could also be harmed by any reputational damage with customers, investors or third parties with whom we work, and our competitive position could be adversely impacted.
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Uncertainty surrounding and future changes to healthcare law in the United States may adversely affect our business.
The healthcare regulatory environment in the U.S. is currently subject to significant uncertainty and the industry may in the future continue to experience fundamental change as a result of
regulatory reform. In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010
(collectively, the “healthcare reform law”), a sweeping measure intended to expand healthcare coverage within the United States, primarily through the imposition of health insurance mandates on
employers and individuals and expansion of the Medicaid program. The healthcare reform law, among other things: (i) addressed a new methodology by which rebates owed by manufacturers under the
Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; (ii) increased the minimum Medicaid rebates owed by manufacturers under the Medicaid
Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations; (iii) established annual fees and taxes on manufacturers of certain branded
prescription drugs; (iv) expands the availability of lower pricing under the 340B drug pricing program by adding new entities to the program; and (v) established a new Medicare Part D coverage gap
discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a
condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D. On April 1, 2016, final regulations issued by the Centers for Medicare and Medicaid Services to implement the
changes to the Medicaid Drug Rebate Program under the healthcare reform law became effective. In addition, the new law established an abbreviated licensure pathway for products that are drugs made
by a living organism or derived from a living organism, commonly referred to as biosimilars, to become FDA-approved biological products, with provisions covering exclusivity periods and a specific
reimbursement methodology for biosimilars.
However, some provisions of the healthcare reform law have yet to be fully implemented, and President Donald Trump has vowed to repeal the healthcare reform law. On January 20, 2017,
President Trump signed an executive order stating that the administration intended to seek prompt repeal of the healthcare reform law, and, pending repeal, directed the U.S. Department of Health and
Human Services and other executive departments and agencies to take all steps necessary to limit any fiscal or regulatory burdens of the healthcare reform law. On October 12, 2017, President Trump
signed another executive order directing certain federal agencies to propose regulations or guidelines to permit small businesses to form association health plans, expand the availability of short-term,
limited duration insurance, and expand the use of health reimbursement arrangements, which may circumvent some of the requirements for health insurance mandated by the healthcare reform law. The
U.S. Congress has also made several attempts to repeal or modify the healthcare reform law. There is no guarantee whether the healthcare reform law will remain in effect or be repealed or replaced. In the
coming years, additional changes could be made to U.S. governmental healthcare programs and U.S. healthcare laws that could significantly impact the success of our products. We cannot predict what
other legislation relating to our business or to the health care industry may be enacted, or what effect such legislation may have on our business, prospects, operating results and financial condition.
In addition, federal, state and foreign governmental authorities are likely to continue efforts to control the price of drugs and reduce overall healthcare costs. These efforts could have an adverse
impact on our ability to market products and generate revenues in the United States and foreign countries.
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Certain of our business practices could become subject to scrutiny by regulatory authorities, as well as to lawsuits brought by private citizens under federal and state laws. Failure to comply with
applicable law or an adverse decision in lawsuits may result in adverse consequences to us.
The laws governing our conduct in the United States are enforceable by criminal, civil and administrative penalties. Violations of laws such as the Federal Food, Drug and Cosmetic Act (the
“FDCA”), the Federal False Claims Act (the “FCA”), the Public Health Service Act (the “PHS Act”), the Physician Payments Sunshine Act or a provision of the U.S. Social Security Act known as the
“Anti-Kickback Law,” or any regulations promulgated under their authority may result in jail sentences, fines or exclusion from federal and state health care programs, as may be determined by the
Department of Health and Human Services, the Department of Defense, other federal and state regulatory authorities and the federal and state courts. There can be no assurance that our activities will not
come under the scrutiny of regulators and other government authorities or that our practices will not be found to violate applicable laws, rules and regulations or prompt lawsuits by private citizen
“relators” under federal or state false claims laws.
For example, under the Anti-Kickback Law, and similar state laws and regulations, even common business arrangements, such as discounted terms and volume incentives for customers in a
position to recommend or choose drugs and devices for patients, such as physicians and hospitals, can result in substantial legal penalties, including, among others, exclusion from Medicare and Medicaid
programs, if those business arrangements are not appropriately structured; therefore, our arrangements with referral sources must be structured with care to comply with applicable requirements. Also,
certain business practices, such as payment of consulting fees to healthcare providers, sponsorship of educational or research grants, charitable donations, interactions with healthcare providers that
prescribe products for uses not approved by the FDA and financial support for continuing medical education programs, must be conducted within narrowly prescribed and controlled limits and in
accordance with the Physician Payments Sunshine Act to avoid any possibility of wrongfully influencing healthcare providers to prescribe or purchase particular products or as a reward for past
prescribing. Significant enforcement activity has been the result of actions brought by relators, who file complaints in the name of the United States (and if applicable, particular states) under federal and
state False Claims Act statutes and can be entitled to receive a significant portion (often as great as 30%) of total recoveries. Also, violations of the False Claims Act can result in treble damages, and each
false claim submitted can be subject to a penalty of up to $22,363 per claim. The healthcare reform law imposes new reporting and disclosure requirements for pharmaceutical and medical device
manufacturers with regard to a broad range of payments, ownership interests, and other transfers of value made to certain U.S. physicians and teaching hospitals. A number of states have similar laws in
place. Additional and stricter prohibitions could be implemented by federal and state authorities. On the other hand, as President Trump has vowed to repeal the healthcare reform law, it is uncertain
whether such data collection obligations would be repealed or replaced with new regulations. Where practices have been found to involve improper incentives to use products, government investigations
and assessments of penalties against manufacturers have resulted in substantial damages and fines. Many manufacturers have been required to enter into consent decrees, corporate integrity agreements, or
orders that prescribe allowable corporate conduct. Failure to satisfy requirements under the FDCA can also result in penalties, as well as requirements to enter into consent decrees or orders that prescribe
allowable corporate conduct.
To market and sell our products outside the United States, we must obtain and maintain regulatory approvals and comply with regulatory requirements in such jurisdictions. The approval
procedures vary among countries in complexity and timing. We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all, and in such case, we would be
precluded from commercializing products in those markets. In addition, some countries, particularly the countries of the European Union, regulate the pricing of prescription pharmaceuticals. In these
countries, pricing discussions with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some
countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. Such trials may be time-consuming and expensive and
may not show an advantage in cost-efficacy for our products. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, in either the United
States or the European Union, we could be adversely affected. Also, under the FCPA, the United States has regulated conduct by U.S. businesses occurring outside of the United States, generally
prohibiting remuneration to foreign officials for the purpose of obtaining or retaining business.
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To enhance compliance with applicable health care laws, and mitigate potential liability in the event of noncompliance, regulatory authorities, such as the Department of Health and Human
Services’ Office of Inspector General (“OIG”), have recommended the adoption and implementation of a comprehensive health care compliance program that generally contains the elements of an
effective compliance and ethics program described in Section 8B2.1 of the U.S. Sentencing Commission Guidelines Manual. Increasing numbers of U.S.-based pharmaceutical companies have such
programs. We have not adopted U.S. healthcare compliance and ethics programs that generally incorporate the HHS OIG’s recommendations. Even if we do, having such a program can be no assurance
that we will avoid any compliance issues.
We could be adversely affected if other government or private third-party payors decrease or otherwise limit the amount, price, scope or other eligibility requirements for reimbursement for the
purchasers of our products.
Prices in many of our principal markets are subject to local regulation and certain pharmaceutical products, such as plasma-derived protein therapeutics, are subject to price controls. In the United
States, where pricing levels for our products are substantially established by third-party payors, a reduction in the payors’ amount of reimbursement for a product may cause groups or individuals
dispensing the product to discontinue administration of the product, to administer lower doses, to substitute lower cost products or to seek additional price-related concessions. These actions could have a
negative effect on our financial results, particularly in cases where our products command a premium price in the marketplace or where changes in reimbursement rates induce a shift in the site of
treatment. The existence of direct and indirect price controls and pressures over our products has affected, and may continue to materially adversely affect, our ability to maintain or increase gross
margins.
Also, the intended use of a drug product by a physician can affect pricing. Physicians frequently prescribe legally available therapies for uses that are not described in the product’s labeling and
that differ from those tested in clinical studies and approved by the FDA or similar regulatory authorities in other countries. These off-label uses are common across medical specialties, and physicians
may believe such off-label uses constitute the preferred treatment or treatment of last resort for many patients in varied circumstances. If reimbursement for off-label uses of products is not allowed by
Medicare or other third-party payors, including those in the United States or the European Union, we could be adversely affected. For example, CMS could initiate an administrative procedure known as a
National Coverage Determination (“NCD”), by which the agency determines which uses of a therapeutic product would be reimbursable under Medicare and which uses would not. This determination
process can be lengthy, thereby creating a long period during which the future reimbursement for a particular product may be uncertain.
Current and future accounting pronouncements and other financial reporting standards, especially but not only concerning revenue recognition, might negatively impact our financial results.
We regularly monitor our compliance with applicable financial reporting standards and review new pronouncements and drafts thereof that are relevant to us. As a result of new standards,
changes to existing standards (including the new IFRS 15 on revenue from contracts with customers that we will need to adopt in 2018) and changes in their interpretation, we might be required to change
our accounting policies, particularly concerning revenue recognition, to alter our operational policies so that they reflect new or amended financial reporting standards, or to restate our published financial
statements. Such changes might have an adverse effect on our reputation, business, financial position, and profit, or cause an adverse deviation from our revenue and operating profit target.
We are subject to extensive environmental, health and safety, and other laws and regulations.
Our business involves the controlled use of hazardous materials, various biological compounds and chemicals. The risk of accidental contamination or injury from these materials cannot be
eliminated. If an accident, spill or release of any regulated chemicals or substances occurs, we could be held liable for resulting damages, including for investigation, remediation and monitoring of the
contamination, including natural resource damages, the costs of which could be substantial. We are also subject to numerous environmental, health and workplace safety laws and regulations, including
those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials and chemicals. Although we maintain workers’ compensation insurance to cover the
costs and expenses that may be incurred because of injuries to our employees resulting from the use of these materials, this insurance may not provide adequate coverage against potential liabilities.
Additional or more stringent federal, state, local or foreign laws and regulations affecting our operations may be adopted in the future. We may incur substantial capital costs and operating expenses and
may be required to obtain consents to comply with any of these or certain other laws or regulations and the terms and conditions of any permits required pursuant to such laws and regulations, including
costs to install new or updated pollution control equipment, modify our operations or perform other corrective actions at our respective facilities. In addition, fines and penalties may be imposed for
noncompliance with environmental, health and safety and other laws and regulations or for the failure to have, or comply with the terms and conditions of, required environmental or other permits or
consents. We are subject to future audits by the Environmental Health Department of the Regional Health Bureau of the IMOH and the Ministry of Environmental Protection of Israel and may be required
to perform certain actions from time to time in order to comply with these guidelines and their requirements. We do not expect the costs of complying with these guidelines to be material to our business.
See “Item 4. Information on the Company — Environmental.”
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Under the Israeli Restrictive Trade Practices Law, 5758-1988 (the “Restrictive Trade Practices Law”), a company that supplies or acquires more than 50% of any product or service in Israel in a
relevant market may be deemed to be a monopoly. A monopolist is prohibited from participating in certain business practices, including unreasonably refusing to sell products or provide services over
which a monopoly exists, charging unfair prices for such products or services, and abusing its position in the market in a manner that might reduce business competition or harm the public. In addition, the
General Director of the Israeli Antitrust Authority may determine that a company is a monopoly and has the right to order such company to change its conduct in matters that may adversely affect
business competition or the public, including by imposing restrictions on its conduct. Depending on the analysis and the definition of the relevant product markets in which we operate, we may be deemed
to be a “monopoly” under the Israeli Restrictive Trade Practices Law with respect to certain of our products. Furthermore, following an amendment to the Restrictive Trade Practices Law that became
effective in August 2015, which repealed the statutory exemption that existed under the Restrictive Trade Practices Law for restrictive arrangements that were mutually exclusive arrangements, we may
face difficulties in certain cases negotiating new distribution agreements with foreign pharmaceutical manufacturers and may need to amend previously executed agreements or seek a specific exemption
from the Israeli Antitrust Authority for such arrangements, and we may not be successful in negotiating such new agreements or amending such agreements or receiving such exemptions.
We have entered into a collective bargaining agreement with the employees' committee and the Histadrut (General Federation of Labor in Israel), and we could incur labor costs or experience work
stoppages or labor strikes as a result of any disputes in connection with such agreement.
In December 2013, we signed a collective bargaining agreement with the employees' committee established by our employees at our Beit Kama facility and the Histadrut (General Federation of
Labor in Israel), which expired in December 2017. We are currently in the process of negotiating the renewal of the collective bargaining agreement. In the process of negotiating the initial collective
bargaining agreement in 2013, two work stoppages occurred, and additional work stoppages may occur during the current process of negotiating the renewal of the collective bargaining agreement. In
October 2016, the General Federation of Labor in Israel authorized our employees' committee to declare a labor dispute, which led to short-term work stoppages and if such disputes are authorized in the
future it may lead to the occurrence of work stoppages or labor strikes. Although work stoppages have not had a material adverse effect on our business or financial condition in the past, any future
disputes with the committee and the Histadrut over the implementation or the interpretation or the renewal of the collective bargaining agreement may lead to additional labor costs and/or work stoppages,
which could adversely affect our business operations, including through a loss of revenue and strained relationships with customers.
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Recently enacted tax legislation in the United States may impact our business.
On December 22, 2017, the U.S. President signed into law federal tax legislation commonly referred to as the Tax Cuts and Jobs Act. The Tax Cuts and Jobs Act provides for significant and
wide-ranging changes to the U.S. Internal Revenue Code. The reforms are complex, and it will take some time to assess the implications thoroughly. While we are not currently a U.S. tax filer there can be
no assurance that these tax reforms will not give rise to significant consequences, both immediately and going forward in terms of the our taxation expense. The Tax Cuts and Jobs Act could be subject to
potential amendments and technical corrections, any of which could lessen or increase adverse impacts of the law.
Risks Related to Intellectual Property
Our success depends in part on our ability to obtain and maintain protection in the United States and other countries for the intellectual property relating to or incorporated into our technology and
products, including the patents protecting our manufacturing process.
Our success depends in large part on our ability to obtain and maintain protection in the United States and other countries for the intellectual property covering or incorporated into our technology
and products, especially intellectual property related to our manufacturing processes. At present, we consider our two patents relating to our manufacturing process to be material to the operation of our
business as a whole.
However, the patent landscape in the biotechnology and pharmaceutical fields is highly complicated and uncertain and involves complex legal, factual and scientific questions. Changes in either
patent laws or in the interpretation of patent laws in the United States and other countries may diminish the value and strength of our intellectual property or narrow the scope of our patent protection. In
addition, we may fail to apply for or be unable to obtain patents necessary to protect our technology or products or enforce our patents due to lack of information about the exact use of our processes by
third parties. Even if patents are issued to us or to our licensors, they may be challenged, narrowed, invalidated, held to be unenforceable or circumvented, which could limit our ability to prevent
competitors from using similar technology or marketing similar products, or limit the length of time our technologies and products have patent protection. Additionally, many of our patents relate to the
processes we use to produce our products, not to the products themselves. In many cases, the plasma-derived products we produce or develop in the future will not, in and of themselves, be patentable.
Since many of our patents relate to processes or uses thereof , if a competitor is able to utilize a process that does not rely on our protected intellectual property, that competitor could sell a plasma-derived
product similar to one we have developed or sell it without infringing these patents.
Patent rights are territorial; thus, any patent protections we have will only be enforceable in those countries in which we have secured patents. In addition, the laws of certain countries do not
protect our intellectual property rights to the same extent as do the laws of the U.S. and the European Union. Competitors may successfully challenge our patents, produce similar drugs or products that do
not infringe our patents, or produce drugs in countries where we have not applied for patent protection or that do not recognize or provide enforcement mechanisms for our patents. Furthermore, it is not
possible to know the scope of claims that will be allowed in published applications or which claims of granted patents, if any, will be deemed enforceable in a court of law.
Due to the extensive time needed to develop, test and obtain regulatory approval for our therapeutic candidates or any product we may sell or market, any patents that protect our therapeutic
candidates or any product we may sell or market may expire early during commercialization. This may reduce or eliminate any market advantages that such patents may give us. Following patent
expiration, we may face increased competition through the entry of generic products into the market and a subsequent decline in market share and profits.
In some cases we may rely on our licensors or partners to conduct patent prosecution, patent maintenance or patent defense on our behalf. Therefore, our ability to ensure that these patents are
properly prosecuted, maintained, or defended may be limited, which may adversely affect our rights in our therapeutic candidates and potential approved for marketing products. Any failure by our
licensors or development or commercialization partners to properly conduct patent prosecution, maintenance, enforcement, or defense could materially harm our ability to obtain suitable patent protection
covering our therapeutic candidates or products or ensure freedom to commercialize the products in view of third-party patent rights, thereby materially reducing our potential profits.
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Our patents also may not afford us protection against competitors or other third parties with similar technology. Because patent applications in the United States and many other jurisdictions are
typically not published until 18 months after their filing, if at all, and because publications of discoveries in scientific literature often lag behind actual discoveries, neither we nor our licensors can be
certain that we or they were the first to make the inventions claimed in our or their issued patents or pending patent applications, or that we or they were the first to file for protection of the inventions set
forth in such patent applications. As a result, the patents we own and license may be invalidated in the future, and the patent applications we own and license may not be granted. For example, if a third
party has also filed a patent application covering an invention similar to one covered in one of our patent applications, we may be required to participate in an adversarial proceeding, known as an
“interference proceeding,” declared by the U.S. Patent and Trademark Office ("USPTO") or its foreign counterparts to determine priority of invention. In 2012, the Leahy-Smith America Invents Act
(“AIA”) created a new legal proceeding, the inter partes review petition, that allows third parties to challenge the validity of patents before the Patent Trials and Appeals Board.
The costs of these proceedings could be substantial and our efforts in them could be unsuccessful, resulting in a loss of our anticipated patent position. In addition, if a third party prevails in such
a proceeding and obtains an issued patent, we may be prevented from practicing technology or marketing products covered by that patent. Additionally, patents and patent applications owned by third
parties may prevent us from pursuing certain opportunities such as entering into specific markets or developing or commercializing certain products or reduce the cost effectiveness of the relevant
business as a result of needing to make royalty payments or other business conciliations. Finally, we may choose to enter into markets where certain competitors have patents or patent protection over
technology that may impede our ability to compete effectively.
Our patents expire at various dates between 2018 and 2027. However, because of the extensive time required for development, testing and regulatory review of a potential product, it is possible
that, before any of our products can be commercialized, any related patent may expire or remain in force for only a short period following commercialization, thereby limiting advantages of the patent.
Our pending and future patent applications may not lead to the issuance of patents or, if issued, the patents may not be issued in a form that will provide us with any competitive advantage. We also cannot
guarantee that: any of our present or future patents or patent claims or other intellectual property rights will not lapse or be invalidated, circumvented, challenged or abandoned; our intellectual property
rights will provide competitive advantages or prevent competitors from making or selling competing products; our ability to assert our intellectual property rights against potential competitors or to settle
current or future disputes will not be limited by our agreements with third parties; any of our pending or future patent applications will be issued or have the coverage originally sought; our intellectual
property rights will be enforced in jurisdictions where competition may be intense or where legal protection may be weak; or we will not lose the ability to assert our intellectual property rights against, or
to license our technology to, others and collect royalties or other payments. In addition, our competitors or others may design around our patents or protected technologies. Effective protection of our
intellectual property rights may also be unavailable, limited or not applied in some countries, and even if available, we may fail to pursue or obtain necessary intellectual property protection in such
countries. In addition, the legal systems of certain countries do not favor the aggressive enforcement of patents and other intellectual property rights, and the laws of foreign countries may not protect our
rights to the same extent as the laws of the United States. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or
identical to ours. In order to preserve and enforce our patent and other intellectual property rights, we may need to make claims, apply certain patent or other regulatory procedures or file lawsuits against
third parties. Such proceedings could entail significant costs to us and divert our management’s attention from developing and commercializing our products. Lawsuits may ultimately be unsuccessful, and
may also subject us to counterclaims and cause our intellectual property rights to be challenged, narrowed, invalidated or held to be unenforceable.
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Additionally, unauthorized use of our intellectual property may have occurred or may occur in the future, including, for example, in the production of counterfeit versions of our products.
Counterfeit products may use different and possibly contaminated sources of plasma and other raw materials, and the purification process involved in the manufacture of counterfeit products may raise
additional safety concerns, over which we have no control. Although we have taken steps to minimize the risk of unauthorized uses of our intellectual property, including for the production of counterfeit
products, any failure to identify unauthorized use of, and otherwise adequately protect, our intellectual property could adversely affect our business, including reducing the demand for our products.
Additionally, any reported adverse events involving counterfeit products that purported to be our products could harm our reputation and the sale of our products in particular and consumer willingness to
use plasma-derived therapeutics in general. Moreover, if we are required to commence litigation related to unauthorized use, whether as a plaintiff or defendant, such litigation would be time-consuming,
force us to incur significant costs and divert our attention and the efforts of our management and other employees, which could, in turn, result in lower revenue and higher expenses.
In addition to patented technology, we rely on our unpatented proprietary technology, trade secrets, processes and know-how.
We rely on proprietary information (such as trade secrets, know-how and confidential information) to protect intellectual property that may not be patentable, or that we believe is best protected
by means that do not require public disclosure. We generally seek to protect this proprietary information by entering into confidentiality agreements, or consulting, services, material transfer agreements or
employment agreements that contain non-disclosure and non-use provisions, as well as ownership provisions, with our employees, consultants, service providers, contractors, scientific advisors and third
parties. However, we may fail to enter into the necessary agreements, and even if entered into, these agreements may be breached or otherwise fail to prevent disclosure, third-party infringement or
misappropriation of our proprietary information, may be limited as to their term and may not provide an adequate remedy in the event of unauthorized disclosure or use of proprietary information. We
have limited control over the protection of trade secrets used by our third-party manufacturers, suppliers, other third parties which are granted with license to use our know-how and former employees and
could lose future trade secret protection if any unauthorized disclosure of such information occurs. In addition, our proprietary information may otherwise become known or be independently developed
by our competitors or other third parties. To the extent that our employees, consultants, service providers, contractors, scientific advisors and other third parties use intellectual property owned by others in
their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our
proprietary rights, and failure to obtain or maintain protection for our proprietary information could adversely affect our competitive business position. Furthermore, laws regarding trade secret rights in
certain markets where we operate may afford little or no protection to our trade secrets.
We also rely on physical and electronic security measures to protect our proprietary information, but we cannot provide assurance that these security measures will not be breached or provide
adequate protection for our property. There is a risk that third parties may obtain and improperly utilize our proprietary information to our competitive disadvantage. We may not be able to detect or
prevent the unauthorized use of such information or take appropriate and timely steps to enforce our intellectual property rights. See-"Our business and operations would suffer in the event of computer
system failures, cyber-attacks on our systems or deficiency in our cyber security measures."
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Changes in either U.S. or foreign patent law or in the interpretation of such laws could diminish the value of patents in general, thereby impairing our ability to protect our products.
Our success, like the success of many other biotechnology companies, is heavily dependent on intellectual property and on patents in particular. The procurement and enforcement of patents in
the biotechnology industry is complex from a technological and legal standpoint, and the process is therefore costly, time-consuming and inherently uncertain. In addition, on September 16, 2011, the AIA
was signed into law. The AIA included a number of significant changes to U.S. patent law, including provisions that affect the way patent applications are prosecuted. An important change introduced by
the AIA is that, as of March 16, 2013, the United States transitioned to a “first-to-file” system for deciding which party should be granted a patent when two or more patent applications are filed by
different parties claiming the same invention. A third party that files a patent application with the USPTO after that date but before us could therefore be awarded a patent covering an invention of ours
even if we had made the invention before it was made by the third party. As a result of this change of law, if we do not promptly file a patent application at the time of a new product’s invention, and if a
third party subsequently invented and patented such product, we would lose our right to patent such invention.
The AIA also introduced new limitations on where a patentee may file a patent infringement suit and new opportunities for third parties to challenge any issued patent in the USPTO. Such
changes apply to all of our U.S. patents, even those issued before March 16, 2013. Because of a lower evidentiary standard necessary to invalidate a patent claim in USPTO proceedings compared to the
evidentiary standard in U.S. federal court, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would
be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have
been invalidated if first challenged by the third party as a defendant in a district court action.
Depending on decisions by the U.S. Congress, federal courts, the USPTO, or similar authorities in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable
ways that would weaken our ability to obtain new patents and enforce our existing and future patents.
If we are unable to protect our trademarks from infringement, our business prospects may be harmed.
We own trademarks that identify certain of our products, our business name and our logo, and have registered these trademarks in certain key markets. Although we take steps to monitor the
possible infringement or misuse of our trademarks, it is possible that third parties may infringe, dilute or otherwise violate our trademark rights. Any unauthorized use of our trademarks could harm our
reputation or commercial interests. In addition, our enforcement against third-party infringers or violators may be unduly expensive and time-consuming, and the outcome may be an inadequate remedy.
Even if trademarks are issued to us or to our licensors, they may be challenged, narrowed, cancelled, held to be unenforceable or circumvented.
We may be subject to claims that we infringe, misappropriate or otherwise violate the intellectual property rights of third parties.
The conduct of our business, our products or product candidates may infringe or be accused of infringing one or more claims of an issued patent or may fall within the scope of one or more
claims in a published patent application that may be subsequently issued and to which we do not hold a license or other rights. For example, certain of our competitors and other third parties own patents
and patent applications in areas relating to critical aspects of our business and technology, including the separation and purification of proteins, the composition of AAT and the use of AAT for different
indications, and these competitors may in the future allege that we are infringing on their patent rights. We may also be subject to claims that we are infringing, misappropriating or otherwise violating
other intellectual property rights, such as trademarks, copyrights or trade secrets. Third parties could therefore bring claims against us or our strategic partners that would cause us to incur substantial
expenses and, if successful against us, could cause us to pay substantial damages. Further, if such a claim were brought against us or our strategic partners, we or they could be forced to permanently or
temporarily stop or delay manufacturing, exportation or sales of the product or product candidate that is the subject of the dispute or suit.
In addition, we are a party to certain license agreements that may impose various obligations upon us as a licensee, including the obligation to bear the cost of maintaining the patents subject to
the license and to make milestone and royalty payments. If we fail to comply with these obligations, the licensor may terminate the license, in which event we might not be able to market any product that
is covered by the licensed intellectual property.
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If we are found to be infringing, misappropriating or otherwise violating the patent or other intellectual property rights of a third party, or in order to avoid or settle claims, we or our strategic
partners may choose or be required to seek a license, execute cross-licenses or enter into a covenant not to sue agreement from a third party and be required to pay license fees or royalties or both, which
could be substantial. These licenses may not be available on acceptable terms, or at all. Even if we or our strategic partners were able to obtain a license, the rights may be nonexclusive, which could result
in our competitors gaining access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations, if, as a
result of actual or threatened claims, we or our strategic partners are unable to enter into licenses on acceptable terms.
There have been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. In addition, to the extent
that we gain greater visibility and market exposure as a public company in the United States, we face a greater risk of being involved in such litigation. In addition to infringement claims against us, we
may become a party to other patent litigation and other proceedings, including interference, opposition, cancellation, re-examination and similar proceedings before the USPTO and its foreign
counterparts and other regulatory authorities, regarding intellectual property rights with respect to our products. The cost to us of any patent litigation or other proceeding, even if resolved in our favor,
could be substantial. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace or to conduct our
business in accordance with our plans and budget, and patent litigation and other proceedings may also absorb significant management time.
Some of our employees, consultants and service providers, were previously employed or hired at universities, medical institutes, or other biotechnology or pharmaceutical companies, including
our competitors or potential competitors. While we take steps to prevent them from using the proprietary information or know-how of others in their work for us, we may be subject to claims that we or
they have inadvertently or otherwise used or disclosed intellectual property, trade secrets or other proprietary information of any such employee’s former employer or former ordering service or that they
have breached certain non-compete obligations to their former employers. Litigation may be necessary to defend against these claims and, even if we are successful in defending ourselves, could result in
substantial costs to us or be distracting to our management. If we fail to defend any such claims successfully, in addition to paying monetary damages, we may lose valuable intellectual property rights or
personnel.
Risks Related to Our Ordinary Shares
The requirements of being a public company in the United States, as well as in Israel, may strain our resources and distract our management, which could make it difficult to manage our business,
particularly after we are no longer an “emerging growth company.”
As a public company whose shares are being traded in the United States, as well as in Israel, we are required to comply with various regulatory and reporting requirements, including those
required by the SEC. Complying with these reporting and regulatory requirements is time consuming, and may result in increased costs to us and could have a negative effect on our business, results of
operations and financial condition.
As a public company in the United States, we are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and the requirements of the
Sarbanes-Oxley Act of 2002 (“SOX”). These requirements may place a strain on our systems and resources. The Exchange Act requires that we file annual and current reports with respect to our business
and financial condition. SOX requires that we maintain effective disclosure controls and procedures and internal controls over financial reporting. To maintain and improve the effectiveness of our
disclosure controls and procedures, we may need to commit significant resources, hire additional staff and provide additional management oversight. These activities may divert management’s attention
from other business concerns, which could have a material adverse effect on our business, financial condition and results of operations.
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As an “emerging growth company,” as defined in the JOBS Act, we take advantage of certain temporary exemptions from various reporting requirements, including, but not limited to, not being
required to comply with the auditor attestation requirements of Section 404 of SOX (and the rules and regulations of the SEC thereunder). When these exemptions cease to apply, we expect to incur
additional expenses and devote increased management effort toward ensuring compliance with them. We will cease to be an emerging growth company on or before December 31, 2018 (See “—We are
an “emerging growth company” with reduced reporting requirements that may make our ordinary shares less attractive to investors.”).
Our share price may be volatile.
The market price of our ordinary shares is highly volatile and could be subject to wide fluctuations in price as a result of various factors, some of which are beyond our control. These factors
include:
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actual or anticipated fluctuations in our financial condition and operating results;
overall conditions in the specialty pharmaceuticals market;
loss of significant customers or changes to agreements with our strategic partners;
changes in laws or regulations applicable to our products;
actual or anticipated changes in our growth rate relative to our competitors’;
announcements of clinical trial results, technological innovations, significant acquisitions, strategic alliances, joint ventures or capital commitments by us or our competitors;
changes in key personnel;
fluctuations in the valuation of companies perceived by investors to be comparable to us;
the issuance of new or updated research reports by securities analysts;
disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain intellectual property protection for our technologies;
announcement of, or expectation of, additional financing efforts;
sales of our ordinary shares by us or our shareholders, including pursuant to the registration statement on Form F-3 that we filed in November 2016;
share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
recalls and/or adverse events associated with our products;
the expiration of contractual lock-up agreements with our executive officers and directors; and
general political, economic and market conditions.
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Furthermore, the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market price of equity securities of many companies. Broad
market and industry fluctuations, as well as general economic, political and market conditions, may negatively impact the market price of our ordinary shares.
In the past, companies that have experienced volatility in the market price of their shares have been subject to securities class action litigation or derivative actions. We, as well as our directors
and officers, may also be the target of these types of litigation and actions in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other
business concerns, which could seriously harm our business.
If equity research analysts issue unfavorable commentary or downgrade our ordinary shares, the price of our ordinary shares could decline.
The trading market for our ordinary shares relies in part on the research and reports that equity research analysts publish about us and our business. The price of our ordinary shares could decline
if one or more securities analysts downgrade our ordinary shares or if those analysts issue other unfavorable commentary or cease publishing reports about us or our business.
Future sales of our ordinary shares in the public market could cause our share price to fall.
Sales by us or the shareholders of a substantial number of our ordinary shares in the public market, either on the Tel Aviv Stock Exchange (the “TASE”) or Nasdaq, or the perception that these
sales might occur, could depress the market price of our ordinary shares and could impair our ability to raise capital through the sale of additional equity securities. As of December 31, 2017, we had
40,262,819 ordinary shares outstanding.
On November 28, 2016, we filed a registration statement on Form F-3 with the SEC utilizing a “shelf” registration process. Under this shelf registration process, we may offer from time to time
up to an aggregate of $100,000,000 of our ordinary shares in one or more offerings. In August 2017, pursuant to such shelf registration statement, we completed an underwritten public offering of an
aggregate of 3,833,334 ordinary shares for total gross proceeds of approximately $17.3 million.
Furthermore, except for shares held by our affiliates as contemplated by Rule 144 under the U.S. Securities Act of 1933, as amended (the “Securities Act”), all of the ordinary shares that are
outstanding as of December 31, 2017, as well as the 2,572,372 ordinary shares issuable upon exercise of outstanding options and the 76,512 restricted shares granted to certain managers, are freely
tradable in the United States without restrictions or further registration under the Securities Act. Approximately 21% of our outstanding ordinary shares are beneficially owned by affiliates. These entities
could resell the shares into the public markets in the United States in the future in accordance with the requirements of Rule 144, which include certain limitations on volume.
In addition, according to the provisions of a certain registration rights agreement, Damar Chemicals Inc., a company registered in Panama (“Damar”), Leon Recanati, Gov Financial Holdings
Ltd., a company organized under the laws of the State of Israel (“Gov”) and wholly-owned by Mr. Recanati, and David Tsur and their respective affiliates, are entitled, until no later than June 2018, to
require that we register their 8,386,561 ordinary shares under the Securities Act for resale into the public markets in the United States. All shares sold pursuant to an offering covered by such registration
statement will be freely tradable in the United States, except for shares purchased by affiliates.
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The significant share ownership positions of Leon Recanati, the current Chairman of our board of directors, and the Hahn family may limit our shareholders’ ability to influence corporate matters.
Leon Recanati, the Chairman of our board of directors, and the Hahn family (including Jonathan Hahn, a member of our board of directors), owned, directly and indirectly, 9.1% and 8.35% of
our outstanding ordinary shares, respectively, as of December 31, 2017. Accordingly, if Leon Recanati and the Hahn family vote the shares that they own or control together, they will be able to
significantly influence the outcome of matters required to be submitted to our shareholders for approval, including decisions relating to the election of our board of directors and the outcome of any
proposed merger or consolidation of our company. Their interests may not be consistent with those of our other shareholders. In addition, these parties’ significant interest in us may discourage third
parties from seeking to acquire control of us, which may adversely affect the market price of our shares. On March 6, 2013, a shareholders agreement was entered into, effective March 4, 2013, pursuant
to which Mr. Recanati and any company controlled by him (collectively, the “Recanati Group”), on the one hand, and Damar, TUTEUR S.A.C.I.F.I.A (“Tuteur”) (companies controlled by the Hahn
family) and their affiliates (collectively, the “Damar Group”), on the other hand, have each agreed to vote the ordinary shares beneficially owned by them in favor of the election of director nominees
designated by the other group as follows: (i) three director nominees, so long as the other group beneficially owns at least 7.5% of our outstanding share capital, (ii) two director nominees, so long as the
other group beneficially owns at least 5.0% (but less than 7.5%) of our outstanding share capital, and (iii) one director nominee, so long as the other group beneficially owns at least 2.5% (but less than
5.0%) of our outstanding share capital. In addition, to the extent that after the designation of the foregoing director nominees there are additional director vacancies, each of the Recanati Group and Damar
Group have agreed to vote the ordinary shares beneficially owned by them in favor of such additional director nominees designated by the party who beneficially owns the larger voting rights in our
Company. We are not party to such agreement or bound by its terms.
Our ordinary shares are traded on more than one market and this may result in price variations.
Our ordinary shares have been traded on the TASE since August 2005, and on Nasdaq since May 2013. Trading in our ordinary shares on these markets takes place in different currencies (U.S.
dollars on Nasdaq and NIS on the TASE), and at different times (as a result of different time zones, trading days and public holidays in the United States and Israel). The trading prices of our ordinary
shares on these two markets may differ due to these and other factors. Any decrease in the price of our ordinary shares on the TASE could cause a decrease in the trading price of our ordinary shares on
Nasdaq, and a decrease in the price of our ordinary shares on Nasdaq could likewise cause a decrease in the trading price of our ordinary shares on the TASE.
Our U.S. shareholders may suffer adverse tax consequences if we are characterized as a passive foreign investment company.
Generally, if, for any taxable year, at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable to assets that produce passive income or are held for
the production of passive income, we would be characterized as a passive foreign investment company (“PFIC”) for U.S. federal income tax purposes. If we are characterized as a PFIC, our U.S.
shareholders may suffer adverse tax consequences, including having gains realized on the sale of our ordinary shares treated as ordinary income, rather than capital gain, the loss of the preferential rate
applicable to dividends received on our ordinary shares by individuals who are U.S. Holders (as defined in “Item 10. Additional Information — E. Taxation — United States Federal Income Taxation”),
and having interest charges apply to distributions by us and the proceeds of share sales. See “Item 10. Additional Information — E. Taxation — United States Federal Income Taxation.”
We are a “foreign private issuer” and have disclosure obligations that are different from those of U.S. domestic reporting companies.
We are a foreign private issuer and are not subject to the same requirements that are imposed upon U.S. domestic issuers by the SEC. Under the Exchange Act, we are subject to reporting
obligations that, in certain respects, are less detailed and less frequent than those of U.S. domestic reporting companies. For example, we are not required to issue quarterly reports, proxy statements that
comply with the requirements applicable to U.S. domestic reporting companies, or individual executive compensation information that is as detailed as that required of U.S. domestic reporting companies.
We also have four months after the end of each fiscal year to file our annual reports with the SEC and are not required to file current reports as frequently or promptly as U.S. domestic reporting
companies. Furthermore, our officers, directors and principal shareholders are exempt from the requirements to report short-swing profit recovery contained in Section 16 of the Exchange Act.
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As we are a “foreign private issuer” and follow certain home country corporate governance practices, our shareholders may not have the same protections afforded to shareholders of companies that
are subject to all Nasdaq corporate governance requirements.
As a foreign private issuer, we have the option to follow Israeli corporate governance practices rather than certain corporate governance requirements of Nasdaq, except to the extent that such
laws would be contrary to U.S. securities laws, and provided that we disclose the requirements we are not following and describe the home country practices we follow instead. We have relied on this
“foreign private issuer exemption” with respect to all the items listed under the heading “Item 16G. Corporate Governance”, including with respect to shareholder approval requirements in respect of
equity issuances and equity-based compensation plans, the requirement to have independent oversight on our director nominations process and to adopt a formal written charter or board resolution
addressing the nominations process, the quorum requirement for meetings of our shareholders and the Nasdaq requirement to have a formal charter for the compensation committee. We may in the future
elect to follow home country practices in Israel with regard to other matters. As a result, our shareholders may not have the same protections afforded to shareholders of companies that are subject to all
Nasdaq corporate governance requirements. See “Item 16G. Corporate Governance.”
We have never paid cash dividends on our ordinary shares and we do not anticipate paying any dividends in the foreseeable future. Consequently, any gains from an investment in our ordinary
shares will likely depend on whether the price of our ordinary shares increases, which may not occur.
We have not recently declared or paid any cash dividends on our ordinary shares and do not intend to pay any cash dividends. Any agreements that we may enter into in the future may contain
terms prohibiting or limiting the amount of dividends that may be declared or paid on our ordinary shares. In addition, Israeli law limits our ability to declare and pay dividends, and may subject our
dividends to Israeli withholding taxes. We anticipate that we will retain all of our future earnings for use in the development of our business and for general corporate purposes. Any determination to pay
dividends in the future will be at the discretion of our board of directors. Accordingly, investors must rely on sales of their ordinary shares after price appreciation, which may never occur, as the only way
to realize any future gains on their investments.
We are an “emerging growth company” with reduced reporting requirements that may make our ordinary shares less attractive to investors.
We are an “emerging growth company,” as defined in the JOBS Act, and have taken advantage of certain exemptions from various reporting requirements that are applicable to public companies
generally. For example, for so long as we remain an emerging growth company, we have elected not to have our independent registered public accounting firm provide an attestation report on the
effectiveness of our internal control over financial reporting, as would otherwise be required by Section 404(b) of SOX. This may increase the risk that we fail to detect and remedy any weaknesses or
deficiencies in our internal control over financial reporting.
In general, these reduced reporting requirements allow us to refrain from disclosing information that you may find important. It is also possible that investors may generally find our ordinary
shares less attractive because of our status as an emerging growth company and our more limited disclosure. Any of the foregoing could adversely affect the price and liquidity of our ordinary shares.
We anticipate taking advantage of these disclosure exemptions until we are no longer an “emerging growth company.” We will cease to be an “emerging growth company” upon the earliest of:
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December 31, 2018, which is the last day of the fiscal year in which the fifth anniversary of our initial public offering in the United States has occurred;
the last day of the fiscal year in which our annual gross revenues are $1.07 billion or more;
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the date on which we have, during the previous three-year period, issued more than $1 billion in non-convertible debt securities; or
the date we qualify as a “large accelerated filer” with at least $700 million of equity securities held by non-affiliates.
Risks Relating to Our Incorporation and Location in Israel
Conditions in Israel could adversely affect our business.
We are incorporated under Israeli law and our principal offices and manufacturing facilities are located in Israel. Accordingly, political, economic and military conditions in Israel directly affect
our business. Since the State of Israel was established in 1948, a number of armed conflicts have occurred between Israel and its Arab neighbors. Although Israel has entered into various agreements with
Egypt, Jordan and the Palestinian Authority, there has been terrorist activity with varying levels of severity over the years. During July and August 2014, Israel engaged in an armed conflict with Hamas in
the Gaza Strip, resulting in thousands of rockets being fired from the Gaza Strip and missile strikes against civilian targets in various parts of Israel, which disrupted most day-to-day civilian activity,
particularly in southern Israel, the location of our manufacturing facility. In the event that our facilities are damaged as a result of hostile action or hostilities otherwise disrupt the ongoing operation of our
facilities or the airports and seaports on which we depend to import and export our supplies and products, our ability to manufacture and deliver products to customers could be materially adversely
affected. Additionally, the operations of our Israeli suppliers and contractors may be disrupted as a result of hostile action or hostilities, in which event our ability to deliver products to customers may be
materially adversely affected.
Several countries, principally in the Middle East, restrict doing business with Israel and Israeli companies, and additional countries may impose restrictions on doing business with Israel and
Israeli companies if hostilities in Israel or political instability in the region continues or increases. These restrictions may limit materially our ability to obtain raw materials from these countries or sell our
products to companies in these countries. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners, or significant downturn in the economic
or financial condition of Israel, could adversely affect our operations and product development, cause our sales to decrease and adversely affect the share price of publicly traded companies having
operations in Israel, such as us.
Our operations may be disrupted by the obligations of personnel to perform military service.
As of December 31, 2017, we had 413 employees, all of whom were based in Israel. Certain of our employees may be called upon to perform up to 36 days (and in some cases more) of annual
military reserve duty until they reach the age of 40 (and in some cases, up to 45 or older) and, in emergency circumstances, could be called to active duty. In response to increased tension and hostilities,
there have been since September 2000 occasional call-ups of military reservists, including in connection with the conflicts with Hamas in July and August 2014, and it is possible that there will be
additional call-ups in the future. Our operations could be disrupted by the absence of a significant number of our employees related to their, or their spouse’s, military service or the absence for extended
periods of one or more of our key employees for military service. Such disruption could materially adversely affect our business and results of operations. Additionally, the absence of a significant number
of the employees of our Israeli suppliers and contractors related to military service or the absence for extended periods of one or more of their key employees for military service may disrupt their
operations, in which event our ability to deliver products to customers may be materially adversely affected.
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The tax benefits that are available to us require us to continue to meet various conditions and may be terminated or reduced in the future, which could increase our costs and taxes.
One of our Israeli facilities was granted “Approved Enterprise” status by the Investment Center of the Ministry of Economy and Industry (formerly named the Ministry of Industry, Trade and
Labor) of the State of Israel (the “Investment Center”), under the Israeli Law for the Encouragement of Capital Investments, 1959 (the “Investment Law”), which made us eligible for a grant and certain
tax benefits under that law for a certain investment program. The investment program provided us with a grant in the amount of 24% of our approved investments, in addition to certain tax benefits, which
will apply to the turnover resulting from the operation of such investment program, for a period of up to ten consecutive years from the first year in which we generated taxable income. The tax benefits
under the Approved Enterprise status expired at the end of 2017.
Additionally, we have obtained a tax ruling from the Israeli Tax Authority according to which, among other things, our activity has been qualified as an “industrial activity,” as defined in the
Investment Law, and is also eligible for tax benefits as a “Privileged Enterprise,” which will apply to the turnover attributed to such enterprise, for a period of up to ten years from the first year in which
we generated taxable income. The tax benefits under the Privileged Enterprise status are scheduled to expire at the end of 2020 and 2023.
In order to remain eligible for the tax benefits of a Privileged Enterprise, we must continue to meet certain conditions stipulated in the Investment Law and its regulations, as amended, and must
also comply with the conditions set forth in the tax ruling. These conditions include, among other things, that the production, directly or through subcontractors, of all our products should be performed
within certain regions of Israel. If we do not meet these requirements, the tax benefits would be reduced or canceled and we could be required to refund any tax benefits that we received in the past, in
whole or in part, linked to the Israeli consumer price index, together with interest. Further, these tax benefits may be reduced or discontinued in the future. For example, while we do not expect that the
transfer of manufacturing of Glassia to Shire, or the grant to Shire of the right to use our technology for such manufacturing, would result in the reduction or loss of these tax benefits, according to the tax
ruling that we obtained, we may lose those benefits if it is determined that we do not comply with the conditions set forth in the tax ruling. If these tax benefits are canceled, our Israeli taxable income
would be subject to regular Israeli corporate tax rates. The standard corporate tax rate for Israeli companies was 26.5% for 2014 and 2015, it decreased to 25% in 2016 and 24% in 2017, and has further
decreased to 23% in 2018. For more information about applicable Israeli tax regulations, see “Item 10. Additional Information — E. Taxation — Israeli Tax Considerations and Government Programs.”
In the future, we may not be eligible to receive additional tax benefits under the Investment Law if we increase certain of our activities outside of Israel. Additionally, in the event of a distribution
of a dividend from the abovementioned tax exempt income, in addition to withholding tax at a rate of 20% effective as of 2014 (or a reduced rate under an applicable double tax treaty), we will be subject
to tax on the otherwise exempt income (grossed-up to reflect the pre-tax income that we would have had to earn in order to distribute the dividend) at the corporate tax rate applicable to our
Approved/Privileged Enterprise’s income, which would have been applied had we not enjoyed the exemption. Similarly, in the event of our liquidation or a share buyback, we will be subject to tax on the
grossed up amount distributed or paid at the corporate tax rate which would have been applied to our Privileged Enterprise’s income had we not enjoyed the exemption. For more information about
applicable Israeli tax regulations, see “Item 10. Additional Information — E. Taxation — Israeli Tax Considerations and Government Programs.”
It may be difficult to enforce a U.S. judgment against us and our officers and directors in Israel or the United States, or to assert U.S. securities laws claims in Israel or serve process on our officers
and directors.
We are incorporated in Israel. Substantially all of our directors and executives officers and the Israeli experts named in this Annual Report reside outside the United States. The majority of our
assets and the assets of these persons are located outside the United States. Therefore, it may be difficult for an investor, or any other person or entity, to enforce a U.S. court judgment based upon the civil
liability provisions of the U.S. federal securities laws against us or any of these persons in a U.S. or Israeli court, or to effect service of process upon these persons in the United States. Additionally, it may
be difficult for an investor, or any other person or entity, to assert U.S. securities law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on an alleged violation of
U.S. securities laws on the grounds that Israel is not the most appropriate forum in which to bring such a claim. Even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S.
law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact by expert witnesses, which can be a time-consuming and costly process.
Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel addressing the matters described above.
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Your rights and responsibilities as our shareholder are governed by Israeli law, which may differ in some respects from the rights and responsibilities of shareholders of U.S. corporations.
Since we are incorporated under Israeli law, the rights and responsibilities of our shareholders are governed by our articles of association and Israeli law. These rights and responsibilities differ in
some respects from the rights and responsibilities of shareholders of U.S.-based corporations. In particular, a shareholder of an Israeli company has a duty to act in good faith and in a customary manner in
exercising its rights and performing its obligations towards the company and other shareholders and to refrain from abusing its power in the company, including, among other things, in voting at the
general meeting of shareholders on certain matters, such as an amendment to the company’s articles of association, an increase of the company’s authorized share capital, a merger of the company and
approval of related party transactions that require shareholder approval. A shareholder also has a general duty to refrain from discriminating against other shareholders. In addition, a controlling
shareholder or a shareholder who knows that it possesses the power to determine the outcome of a shareholders vote, or to appoint or prevent the appointment of an office holder in the company has a duty
to act in fairness towards the company. However, Israeli law does not define the substance of this duty of fairness. See “Item 6. Directors, Senior Management and Employees — Fiduciary Duties and
Approval of Specified Related Party Transactions under Israeli Law — Duties of Shareholders.” There is limited case law available to assist us in understanding the nature of this duty or the implications
of these provisions. These provisions may be interpreted to impose additional obligations and liabilities on our shareholders that are not typically imposed on shareholders of U.S. corporations.
Provisions of Israeli law and our articles of association may delay, prevent or make undesirable an acquisition of all or a significant portion of our shares or assets.
Certain provisions of Israeli law and our articles of association could have the effect of delaying or preventing a change in control and may make it more difficult for a third party to acquire us or
for our shareholders to elect different individuals to our board of directors, even if doing so would be beneficial to our shareholders, and may limit the price that investors may be willing to pay in the
future for our ordinary shares. For example, Israeli corporate law regulates mergers and requires that a tender offer be effected when more than a specified percentage of shares in a company are
purchased. Under our articles of association, a merger shall require the approval of two-thirds of the voting rights represented at a meeting of our shareholders and voting on the matter, in person or by
proxy, and any amendment to such provision shall require the approval of 60% of the voting rights represented at a meeting of our shareholders and voting on the matter, in person or by proxy. Further,
Israeli tax considerations may make potential transactions undesirable to us or to some of our shareholders whose country of residence does not have a tax treaty with Israel granting tax relief to such
shareholders from Israeli tax. With respect to certain mergers, Israeli tax law may impose certain restrictions on future transactions, including with respect to dispositions of shares received as
consideration, for a period of two years from the date of the merger. See “Item 10. Additional Information — B. Memorandum and Articles of Association — Acquisitions Under Israeli Law.”
Item 4. Information on the Company
Corporate Information
We were incorporated under the laws of the State of Israel on December 13, 1990 under the name Kamada Ltd. In August 2005, we successfully completed an initial public offering on the TASE.
In June 2013, we successfully completed an initial public offering in the United States on Nasdaq. The address of our principal executive office is 2 Holzman St., Weizmann Science Park, P.O. Box 4081,
Rehovot 7670402, Israel, and our telephone number is +972 8 9406472. Our website address is www.kamada.com. The reference to our website is intended to be an inactive textual reference and the
information on, or accessible through, our website is not intended to be part of this Annual Report.
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We have irrevocably appointed Puglisi & Associates as our agent to receive service of process in any action against us in any United States federal or state court. The address of Puglisi &
Associates is 850 Library Avenue, Suite 204, P.O. Box 885, Newark, Delaware 19715.
Emerging Growth Company
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”). Thus, we may take advantage of certain exemptions from various reporting
requirements that are applicable to public companies generally. For example, we have elected not to have our independent registered public accounting firm provide an attestation report on the
effectiveness of our internal control over financial reporting, as would otherwise be required by Section 404(b) of the Sarbanes-Oxley Act (“SOX”).
We will cease to be an “emerging growth company” upon the earliest of:
·
·
·
·
December 31, 2018, which is the last day of the fiscal year in which the fifth anniversary of our initial public offering in the United States has occurred;
the last day of the fiscal year in which our annual gross revenues are $1.07 billion or more;
the date on which we have, during the previous three-year period, issued more than $1 billion in non-convertible debt securities; or
the date we qualify as a “large accelerated filer” with at least $700 million of equity securities held by non-affiliates.
The JOBS Act also provides that an “emerging growth company” can utilize the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised
accounting standards. However, we have chosen to “opt out” of such extended transition period, and, as a result, we will comply with new or revised accounting standards on the relevant dates on which
adoption of such standards is required for companies that are not “emerging growth companies.” Section 107 of the JOBS Act provides that our decision to opt out of the extended transition period for
complying with new or revised accounting standards is irrevocable.
Capital Expenditures
For a discussion of our capital expenditures, see “Item 5. Operating and Financial Review and Prospects—Liquidity and Capital Resources.”
Business Overview
We are a plasma-derived protein therapeutics company with an existing marketed product portfolio and a late-stage product pipeline. Our proprietary products are produced using our advanced
proprietary technologies and know-how for the separation and purification of proteins derived from human plasma. We produce our plasma-derived protein therapeutics in our advanced cGMP compliant,
FDA-approved, large scale production facility located in Beit Kama, Israel. We use our proprietary platform technology and know-how for the extraction and purification of proteins from human plasma
to produce AAT in a high purity, liquid form, as well as other plasma-derived proteins. AAT is a protein derived from human plasma with known and newly discovered therapeutic roles given its immuno-
modulatory, anti-inflammatory, tissue protective and antimicrobial properties.
45
During 2017 we established a Strategy Committee at the board, which, with the assistance of an external consulting firm, performed a strategic review of our business. Based on that analysis, we
decided to focus our resources in the AATD field, as we believe we have developed extensive commercial, scientific, clinical and regulatory experience (based on multiple clinical trials we performed in
the United States and Europe) in that field. Accordingly, we aim to become the innovator in this field by developing different therapeutic approaches to AATD independently, or through collaborations
with strategic partners. In addition, we decided that the development of AAT for indications other than AATD, such as GvHD, T1D, lung transplantation rejection, etc. will be performed through strategic
collaborations. For that purpose we plan to continue investing in the additional indications, only to the point of developing sufficient data to potentially attract such strategic partners.
Our flagship product, Glassia, is the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA (Glassia is also approved for self-administration). We market
Glassia through a strategic partnership with Shire in the United States, under which the minimum aggregate revenue for Glassia for the years 2018 to 2020 is expected to reach approximately $177 million
and may be expanded to $228 million during that period. Pursuant to the Exclusive Manufacturing, Supply and Distribution Agreement, as amended, after 2020, Shire has no obligation to purchase a
minimum amount of Glassia. Additionally, we estimate that Shire will begin selling Glassia produced in its own manufacturing facility as early as 2021, and pay us royalties. We also market Glassia in
other counties through local distributors. Glassia is an intravenous AAT product that is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to AATD. AAT is a
naturally occurring protein found in a derivative of plasma known as fraction IV. AAT regulates the activity of certain white blood cells known as neutrophils and reduces cell inflammation. Patients with
genetic AATD suffer from a chronic inflammatory state, lung tissue damage and a decrease in lung function.
In addition to Glassia, we are developing Inhaled AAT for AATD. We believe that this second generation AAT product is currently the only aerosolized AATD treatment in advanced stages of
clinical development. We believe that Inhaled AAT for AATD will increase patient convenience and reduce the need for patients to use intravenous infusions of AAT products, thereby further reducing the
risk of infection, decreasing the need for clinic visits or nurse home visits and reducing medical costs. In addition, because Inhaled AAT for AATD would be delivered directly to the affected tissue
through a nebulizer using a lower dosage, we believe that this product, if approved, will enable us to treat significantly more patients from the same amount of plasma and production capacity and
therefore increase our profitability.
We completed a pivotal Phase II/III clinical trial for Inhaled AAT for AATD in Europe and filed the Marketing Authorization Application ("MAA") with the EMA in March 2016. The Phase
II/III clinical trial in Europe, however, did not meet its primary or other pre-defined endpoints. Following our discussions with the EMA in regards to the study results, in July 2017, we withdrew the
MMA in Europe for our Inhaled AAT for AATD, which relied on this single pivotal clinical trial. Following extensive discussions with the EMA, we concluded that the EMA did not view the data
submitted as sufficient, in terms of safety and efficacy, for approval of the MAA, and that the supplementary data needed for approval required an additional clinical trial.
In the United States, we completed a Phase II clinical trial of our Inhaled AAT for AATD, which met its primary endpoint. However, when we presented the data from the European Phase II/III
study to the FDA in April 2016, the FDA expressed concerns and questions about that data, primarily related to the safety and efficacy of Inhaled AAT for the treatment of AATD and the risk/benefit
balance to patients based on that data. We understood that the FDA’s questions and concerns need to be resolved before the agency would allow us to proceed with additional clinical development of
Inhaled AAT in the United States. In order to address the FDA’s concerns and questions, in April 2017, we submitted to the agency the results of the U.S. Phase II data together with a proposed Phase III
synopsis. The FDA then provided us in June 2017 with guidance for further development of the synopsis and requested that we submit a complete proposed study protocol for the next phase prior to
enabling us to continue clinical development and initiate the Phase III study in the United States. In July 2017, we submitted a full study protocol, and in August 2017, in response to the study protocol
and previous submission, the FDA issued a letter stating that it continues to have concerns and questions about the safety and efficacy of the Inhaled AAT. We will need to receive authorization from the
FDA in order to proceed with the clinical development of Inhaled AAT in the United States, including our proposed Phase III clinical trial.
Following, and subject to, receiving IND approval for such trial from the FDA, we plan to initiate an additional pivotal Phase III clinical trial in the United States and resubmit the MAA after
such clinical trial is successfully completed, with the data to be collected in such clinical trial. We may seek to attract partners in this development program. However, it is not certain when we will initiate
such Phase III clinical trial, as the FDA expressed concerns and questions regarding the safety and efficacy of the treatment, and we are currently in discussions with the FDA regarding the regulatory path
forward. See “—Our Product Pipeline and Development Program—Inhaled Formulations of AAT—AATD” and “Risk Factors— Risk Related to Development, Regulatory Approval and
Commercialization of New Products Candidates Including Inhaled AAT.”
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In July 2011, we signed a strategic distribution and supply agreement with Kedrion for the clinical development and marketing in the United States of KamRAB, and in August 2017 we received
FDA approval for anti-rabies immunoglobulin as a post-exposure prophylaxis against rabies infection. We expect to launch KamRAB in the United States, under the trademark "KEDRAB," in 2018.
In November 2017, we signed a supply agreement for marketing of KamRAB with an undisclosed international organization. The agreement extends through 2020 and is expected to generate
total revenues through 2020 for our Company in the total amount of approximately $13 million.
Additionally, in November 2017, we reported the top-line results from the Phase II clinical study conducted in Israel for the indication of newly diagnosed T1D patients. While in the overall
study population no significant treatment effect was observed, in the pre-determined subgroup of patients between the ages of 12 and 18 years old, a trend toward better efficacy was demonstrated in the
high dose arm of AAT (120 mg/kg) represented in terms of beta-cell function preservation, lower average of total daily insulin usage and a better glycemic control measured by lower average HbA1c.
In November 2016, we initiated a Phase II/III clinical trial for the treatment of aGvHD in collaboration with Shire in the United States. In June 2017, Shire informed us of its decision not to
continue with the study. As the result of this decision, the study was halted. In January 2018, we announced a collaboration with a consortium of prominent hospitals led by Mount Sinai Hospital to
evaluate our AAT product for preemption of steroid refractory aGvHD.
We have also initiated a Phase II clinical study with our intravenous AAT product to prevent lung transplantation rejection, and in January 2018, we announced interim results from this study,
which showed that our intravenous AAT demonstrated favorable safety and tolerability profile in 10 patients during first six months of treatment, consistent with previously observed results in other
indications. We also announced that the next interim report is expected in the second half of 2018, following completion of one year of treatment, and top-line results are anticipated in the second half of
2019. We have also completed Phase II clinical studies in Israel for additional novel indications, using formulations of AAT through Inhalation for cystic fibrosis in 2008 and bronchiectasis in 2009. At
present, the development of cystic fibrosis and bronchiectasis products is suspended as we prioritize other products.
With respect to the development of our AAT product for T1D, GvHD and prevention of lung transplantation rejection, our continued investment would be limited to the point where such further
development could generate sufficient data to potentially attract strategic partner(s) to collaborate in the further development of those programs.
We operate in two segments: the Proprietary Products segment, in which we develop and manufacture plasma-derived therapeutics and have a product line consisting of approximately eight
pharmaceutical products that we market in more than 15 countries; and the Distribution segment, in which we leverage our expertise and presence in the Israeli market by distributing drugs manufactured
by third-parties for use in Israel, most of which are produced from plasma or its derivative products. Our product sales in our Proprietary Products segment are predicted to increase until 2020; thereafter,
Shire has no obligation to purchase a minimum amount of Glassia, and we estimate that Shire will begin selling Glassia produced in its own manufacturing facility as early as 2021, and pay us royalties.
As Shire transitions to producing Glassia in its own facilities, we will incur a substantial reduction in revenues (as well as costs of goods sold), driven by the reduction in Glassia manufacturing.
We derived approximately 59%, 52% and 38% of our total revenues in the years ended December 31, 2017, 2016 and 2015, respectively, from sales in the United States, approximately 5%, 5%
and 5% of our total revenues in the years ended December 31, 2017, 2016 and 2015, respectively, from sales in Europe, approximately 5%, 4% and 4% of our total revenues in the years ended December
31, 2017, 2016 and 2015, respectively, from sales in Asia (excluding Israel) and 5%, 5% and 9% of our total revenues in the years ended December 31, 2017, 2016 and 2015, respectively, from sales in
Latin America.
Our Product Portfolio
Our products include plasma-derived protein therapeutics that are either produced in our Proprietary Products segment or marketed and sold in our Distribution segment.
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Proprietary Products Segment
Our products in the Proprietary Products segment consist of plasma-derived protein therapeutics that are administered by injection or infusion. We also manufacture certain products from raw
materials derived from animal sources.
We currently have products that target four product categories: respiratory, immunoglobulins, critical care and other. Our flagship product in the Proprietary Products segment is Glassia, sales of
which, for the years ended December 31, 2017, 2016 and 2015, accounted for approximately 83%, 77% and 70% of our total revenues, in the Proprietary Products segment, respectively. Revenue from
our intravenous AATD products comprised approximately 64%, 56%, and 43% of our total revenues for the years ended December 31, 2017, 2016 and 2015, respectively. Sales of KamRAB and KamRho
(D) for the years ended December 31, 2017, 2016 and 2015 accounted for the substantial balance of total revenues in the Proprietary Products segment.
Product
Respiratory
Glassia (or Ventia in certain countries)
Indication
Intravenous AATD
Immunoglobulins
KamRAB
Prophylaxis of rabies disease
KamRho (D) IM
Prophylaxis of hemolytic disease of newborns
Active Ingredient
Geography
Alpha-1 Antitrypsin (human) United States, Israel, Russia, Brazil,
Argentina, Turkey, Colombia**
Anti-rabies immunoglobulin
(human)
Rho(D) immunoglobulin
(human)
Rho(D) immunoglobulin
(human)
Israel, India, Thailand, El Salvador*, South
Africa, Bosnia, Afghanistan, Russia*,
Mexico*, Georgia*, Ukraine** and South
Korea
Israel, Brazil, India, Argentina, Paraguay,
Chile*, Russia, Kenya, Nigeria, Sri Lanka,
Thailand** and the Palestinian Authority
Israel, India*, Sri Lanka and Argentina*
KamRho (D) IV
Snake bite antiserum
Other Products
Heparin Lock Flush
Kamacaine 0.5%
Treatment of immune thermobocytopunic purpura
Treatment of snake bites by the Vipera palaestinae and the Echis
coloratus
Anti-snake venom
Israel*
To maintain patency of indwelling IV catheter designed for
Heparin sodium
intermittent injection therapy or blood sampling
Local or regional anesthesia or analgesia during surgery,
diagnostic and therapeutic procedures and obstetrical procedures.
Spinal anesthesia for surgery
Bupivacaine HCl
Israel*
Israel
Human transferrin (diagnostical grade)
Not for human use
___________
* We have regulatory approval, but did not market the product in this country in 2017.
** Product was registered, but we have not yet started sales.
Transferrin
United States, Israel, and France
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Respiratory — Glassia
Glassia is an intravenous AAT product produced from fraction IV plasma that is indicated by the FDA for chronic augmentation and maintenance therapy in adults with emphysema due to
congenital AATD. While Glassia does not cure AATD, it supplements the patient’s insufficient physiological levels of AAT and is administered as a chronic treatment. As such, the patient must take
Glassia indefinitely over the course of his or her life in order to maintain the benefits provided by it.
In the United States and Europe, we believe that AATD is currently significantly under-diagnosed and under-treated, as we estimate that only approximately 6% and 2.5% of all potential cases of
AATD are treated in the United States and Europe, respectively, with an aggregate of up to an estimated 180,000 to 190,000 patients suffering from AATD, of which less than 10% have been diagnosed.
According to a 2013 report of the Marketing Research Bureau, the annual cost to the patient of AATD treatment is between $80,000 and $100,000 per patient. In the United States, in some of the
European countries and in Israel, we believe that the majority of the cost of treatment is covered by medical insurance programs.
We estimate that the potential world market for AAT products is significantly larger than current consumption indicates. We believe that the primary reasons for this are the non-availability of
AAT products in many countries, under diagnosis of patients suffering from AATD, expensive and protracted registration processes required to commence sales of AAT products in new markets and the
absence of insurance reimbursement in various countries. As AATD can be diagnosed with a simple blood test, we expect diagnosis of AATD to increase going forward as awareness of AAT increases.
Glassia is the first AAT product in the world that is approved for use in a high purity liquid state, which is ready for infusion and does not require reconstitution and mixing before injection, as is
required from most other competing products. Additionally, in June 2016, the FDA approved an expanded label of Glassia for self-infusion at home after appropriate training. Glassia has a number of
advantages over other intravenous AAT products, including the reduction of the risk of contamination during the preparation and infection during the infusion, reduced potential for allergic reactions due
to the absence of stabilizing agents, simple and easy use by the patient or nurse, and the possible reduction of the nurse’s time during home visits, in the clinic or in the hospital and the ability to self-
infusion at home.
Currently, Glassia has been approved in seven countries. It is sold in five of those countries and also is sold in one additional country, where it has not been approved, on a non-registered named-
patient basis. The majority of sales of Glassia are in the United States, where Glassia was approved by the FDA in July 2010 and sales began in September 2010. As part of the approval, the FDA
requested that we conduct post-approval Phase IV clinical trials, as is common in the pharmaceutical industry, aimed at collecting additional safety and efficacy data for Glassia. In 2010, we submitted our
proposed Phase IV clinical trials to the FDA. Such Phase IV clinical trials began in 2015. Pursuant to our agreement with Shire, the Phase IV clinical trials are financed and managed by Shire, provided
that if the cost of such Phase IV clinical trials exceeds a pre-defined amount, we will participate in financing such trial up to a certain amount by offsetting such amounts from future milestones, sales of
Glassia or royalties from Shire.
We market Glassia in the United States through our partnership with Shire. We market Glassia in Israel by ourselves and in the other countries through our local distributors. Sales to Shire
accounted for approximately 59%, 52% and 37% of our total revenues in the years ended December 31, 2017, 2016 and 2015, respectively. We plan to submit Glassia for marketing approval in additional
countries. Revenues from our intravenous AATD products have grown from approximately $0.6 million in 2009 to $65.93 million in 2017, representing 80% compound annual growth rate.
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Immunoglobulins
KamRAB
KamRAB is a prophylactic treatment against rabies infection that is administered to patients after exposure to an animal suspected of being infected with rabies. KamRAB is a protein therapeutic
derived from hyper-immune plasma, which is plasma that contains high levels of antibodies from donors that have been previously vaccinated by an active rabies vaccine. KamRAB is administered by a
one-time injection, and the precise dosage is a function of the patient’s weight.
According to the World Health Organization, each year, more than 10 million people worldwide are exposed to potential rabies infection. We believe that there are market opportunities for
KamRAB in developing countries, as well as in the United States and Canada. In many developing countries, patients do not receive treatment for suspected rabies due to the lack of availability of
healthcare resources. In the United States, there are currently two registered anti-rabies immunoglobulin, with one of them controlling the market share and we believe that healthcare providers would
seek to diversify their source of supply with our product as an additional FDA approved high-quality product.
We began selling KamRAB in certain countries in Asia and Latin America in 2003, where sales of the product have steadily increased. We sell KamRAB in nine countries, received regulatory
approval to market KamRAB in four other countries, including, since August 2017, in the United States. In July 2011, we signed a strategic distribution and supply agreement with Kedrion for the clinical
development and marketing in the United States of KamRAB, pursuant to which Kedrion agreed to bear all the costs required for the Phase II/III clinical trials. See “— Strategic Partnerships — Kedrion.”
We expect to launch KamRAB in the United States (under the trademark "KEDRAB" in the United States) in 2018 through our collaboration with Kedrion. We believe that receiving the FDA approval
for marketing the product will assist us in our efforts to register KamRAB in additional countries where KamRAB is not currently registered, which we believe would lead to additional sales worldwide.
In November 2017, we signed a supply agreement for sales of KamRAB ex-US with an undisclosed international organization. The agreement extends through 2020 and is expected to generate
total revenues for our company in the total amount of approximately $13 million through 2020.
KamRho (D)
KamRho (D) is indicated for (i) the prevention of hemolytic disease of the newborn (“HDN”), which is a blood disease that occurs where the blood type of the mother is incompatible with the
blood type of the fetus; and (ii) the treatment of immune thrombocytopenic purpura (“ITP”), which is thought to be an autoimmune blood disease in which the immune system destroys the blood’s
platelets, which are necessary for normal blood clotting. KamRho (D) is produced from hyper-immune plasma and is administered through intra-muscular injection (KamRho (D) IM) or through
intravenous infusion (KamRho (D) IV).
According to academic research, approximately 15% of Caucasian women are Rh-negative and, if left untreated, HDN would affect one percent of all newborns and would be responsible for the
death of one baby out of every 2,200 births. In addition, academic research estimates that ITP affects approximately five out of every 100,000 children per year, and two of every 100,000 adults per year
worldwide, although some will recover without treatment. We have completed the registration process for Kam Rho (D), and are selling it in ten countries in Israel, Latin America, Asia, Africa and
Eastern Europe.
Snake Bite Antiserum
Our snake bite antiserum product is used for the treatment of humans that have been bitten by the most common Israeli viper (Vipera palaestinae) and by the Israeli Echis (Echis coloratus). The
venom of these snakes is poisonous and causes, among other symptoms, severe immediate pain with rapid swelling. These snake bites can lead to death if left untreated. Our snake bite antiserum is
produced from hyper-immune serum that has been derived from horses that were immunized against Israeli viper and Israeli Echis venom. This product is the only treatment on the market for Vipera
palaestinae and Echis coloratus snake bites in Israel.
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We developed the snake bite antiserum pursuant to an agreement with the IMOH entered into in March 2009. We completed construction of the production facilities and laboratories for the
product, and successfully passed the IMOH inspections. We began production in August 2011 and commenced sales to the IMOH in 2012. The agreement with the IMOH is automatically renewable for
up to ten additional one-year periods until December 31, 2020, unless the IMOH has provided us with a prior notice of non-renewal of the agreement, prior any automatic renewal term.
Other Products
We also sold additional critical care products including Heparin, an anticoagulant, and Kamacaine, an anesthetic for surgery or obstetric procedures and Transferrin, which is used as a cultural
medium for diagnostic assays and cell cultures. Due to low demand, Heparin was not sold in 2017.
Distribution Segment
Our primary products in the Distribution segment include pharmaceuticals for critical use delivered by injection, infusion or inhalation. We leverage our expertise and presence in the plasma-
derived protein therapeutics market to distribute products in Israel that we believe complement our products in the Proprietary Products segment. Most of the products in our Distribution segment are
produced from plasma or plasma-derivatives, and are manufactured by European companies. IVIG is our primary product in the Distribution segment, comprising approximately 54%, 61% and 61% of
total revenues in the Distribution segment for the years ended December 31, 2017, 2016 and 2015, respectively. Sales of IVIG accounted for approximately 12%, 17% and 24% of our total revenues for
the years ended December 31, 2017, 2016 and 2015, respectively.
The following table sets forth our primary products in our Distribution segment.
Product
Respiratory
Bramitob
Indication
Active Ingredient
Management of chronic pulmonary infection due to pseudomonas aeruginosa in patients six years and older
Tobramycin
with cystic fibrosis
FOSTER
Regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting
Beclomethasone dipropionate, Formoterol fumarate
beta2-agonist) is appropriate
Immunoglobulins
IVIG 5%
Varitect
Zutectra
Hepatect CP
Megalotect
Critical Care
Heparin sodium injection
Treatment of various immunodeficiency-related conditions
Preventive treatment after exposure to the virus that causes chicken pox and zoster herpes
Prevention of hepatitis B virus (HBV) re-infection in HBV-DNA negative patients 6 months after liver
Gamma globulins (IgG) (human)
Varicella zoster immunoglobulin (human)
Human hepatitis B immunoglobulin
transplantation for hepatitis B induced liver failure
Prevent contraction of Hepatitis B by adults and children older than two years
Contains antibodies that neutralize cytomegalovirus viruses and prevent their spread in immunologically
Hepatitis B immunoglobulin (human)
CMV immunoglobulin (human)
impaired patients
Treatment of thrombo-embolic disorders such as deep vein thrombosis, acute arterial embolism or
thrombosis, thrombophlebitis, pulmonary embolism, fat embolism. Prophylaxis of deep vein thrombosis and
thromboembolic events
Heparin sodium
Albumin and Albumin 4%
Maintains a proper level in the patient’s blood plasma
Human serum Albumin
Coagulation Factors
Factor VIII
Factor IX
Vaccinations
IXIARO
Treatment of Hemophilia Type A diseases
Treatment of Hemophilia Type B disease
Coagulation Factor VIII (human)
Coagulation Factor IX (human)
Active immunization against Japanese encephalitis in adults, adolescents, children and infants aged 2
Japanese encephalitis purified inactivated vaccine
months and older
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Our Product Pipeline and Development Program
We are in various stages of clinical development of new product candidates for our Proprietary Products segment. The following table sets forth our primary product pipeline in our Proprietary
Products segment and each such product’s stage of clinical trials:
* Recombinant AAT for AAT Deficiency in early development stages
1. Orphan drug designation (US & EU)
2. Orphan drug designation (US only)
Inhaled Formulations of AAT
We are in the process of development of inhaled formulations of AAT administered through the use of a nebulizer. The nebulizer was developed by PARI for several indications in the respiratory
field, including the treatment of AATD, cystic fibrosis and bronchiectasis.
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AATD
We have been able to leverage our expertise gained from the production of Glassia to develop a stable, high purity Inhaled AAT for AATD, an inhaled AAT product candidate for the treatment of
AATD. Existing treatment for AATD require weekly intravenous infusions of AAT therapeutics. We believe that Inhaled AAT for AATD will significantly improve the patient’s disease condition and the
quality of life of the patients versus current invasive weekly treatment that requires uncomfortable infusion, consumption of time and administration by a medical professional. If approved, Inhaled AAT
for AATD is estimated to be the first AAT product that is not required to be delivered intravenously but, instead is administered by a user-friendly, lightweight and silent nebulizer in up to two short daily
sessions. We believe that Inhaled AAT for AATD will increase patient convenience and reduce or replace the need for patients to use intravenous infusions of AAT products, decreasing the need for clinic
visits or nurse home visits and reducing medical costs. Because of the smaller amount of AAT product used in Inhaled AAT for AATD (since it is applied directly to the site of action rather than
administered systematically) we believe that this product, if approved, will enable us to treat significantly more patients from the same amount of plasma and production capacity and therefore increase
our profitability.
The current standard care for AATD in the United States and in certain European countries is intravenous infusion of an AAT therapeutic. We estimate that only 2% of the AAT dose reaches the
lung when administered intravenously. We have conducted a U.S. phase II clinical study demonstrating that administration of inhaled formulations of AAT through inhalation results in greater dispersion
of AAT to the target lung tissue including the lower lobes and lung periphery. Accordingly, we believe that an inhaled formulation of AAT would require a significantly lower therapeutic dose and would
be more effective in reducing inflammation of the lung tissue and inhibiting the uncontrolled neutrophil elastase that causes the breakdown of the lung tissue and the emphysema. In addition, self-
administration by inhalation is more convenient than intravenous infusion and would also reduce the burden on healthcare providers to administer treatments.
Inhaled AAT for AATD has been designated as an orphan drug for the treatment of AATD in the United States and Europe.
A double blind placebo controlled and randomized Phase II/III pivotal trial, under EMA guidance, started in January 2010 and was completed at the end of 2013. A total of 168 patients
participated in the trial in seven countries in Europe and Canada. Subjects in this trial were administered with a daily dose of Inhaled AAT for AATD or equivalent dose of placebo for 50 consecutive
weeks. The primary endpoint for the trial was the time from randomization to the first event-based exacerbation with a severity of moderate or severe. Other endpoints, which were secondary and tertiary,
included other exacerbation measures, lung function, CT scan and quality of life. The trial was 80% powered based on the number of exacerbation events collected in the study, in order to detect a
difference between the two groups one year later. A 20% difference between the two groups was required to prove efficacy and is considered to be clinically meaningful and would allow the decision to
prescribe treatment. An open label extension of an additional 50 weeks on active drug was offered to study participants in most sites once they completed the initial 50 week period. Treatment in the open
label extension of the trial was completed in November 2014.
Results from our double blind part of the trial indicated that the primary endpoint was not met, although a potentially encouraging signal was seen in lung function measurement. We reported in
September 2014 the results of the study, stating that the primary endpoint of “time to the first moderate or severe exacerbation event” did not show a statistically significant difference between inhaled
formulation of AAT and placebo in the Intent-to-Treat (“ITT”) population and that the study did not show statistically significant differences between inhaled formulation of AAT and placebo in the
secondary exacerbation endpoints measured in the ITT population.
Despite not meeting the primary or secondary endpoints for the ITT population, lung function parameters, including Forced Expiratory Volume in One Second (“FEV1”) % of Slow Vital
Capacity (“SVC”), FEV1 % predicted, FEV1 (liters) and Diffusing capacity (“DLCO”), which were collected to support safety endpoints, showed concordance of a potential treatment effect in the
reduction of the inflammatory injury to the lung that is known to be associated with a reduced loss of respiratory function.
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Our inhaled formulation of AAT therapy showed clinically relevant changes in various lung function measurements for the entire ITT population, a few of which were statistically significant.
This suggests evidence of potential therapeutic activity resulting in a clinically relevant and meaningful effect.
Based on such results, we held pre-submission meetings with the European rapporteur and co-rapporteur in December 2014 with regard to filing MAA with the EMA for our Inhaled AAT for
AATD. The co-rapporteurs advised that they would consider the entire study data once submitted, including post hoc analysis and will not reject the application simply because the primary endpoint of the
study was not met. They agreed that the application fulfills the requirements relating to unmet medical need and benefit to public health and that it may meet the scope of approval if we convincingly
prove the positive benefit-risk balance of the product, by the time of MAA filing. The co-rapporteurs have requested the addition of supplemental data analyses that may address the benefit-risk balance
and support the already available safety and efficacy data.
We performed these post hoc analyses in accordance with guidance received following the meeting with the European rapporteur and co-rapporteur. Results of the post hoc analyses indicate that
after one year of daily inhalation of our Inhaled AAT for AATD, clinically and statistically significant improvements were seen in spirometric measures of lung function, particularly in bronchial airflow
measurements FEV1 (L), FEV1% predicted and FEV1/SVC. These favorable results were even more evident when analyzing the overall treatment effect throughout the full year.
For lung function, overall one year effect:
·
·
·
FEV1 (L) rose significantly in AAT treated patients and decreased in placebo treated patients (+15ml for AAT vs. -27ml for placebo, a 42 ml difference, p=0.0268)
There was a trend towards better FEV1% predicted (0.54% for AAT vs. -0.62% for placebo, a 1.16% difference, p=0.065)
FEV1/SVC% rose significantly in AAT treated patients and decreased in placebo treated patients (0.62% for AAT vs. -0.87% for placebo, a 1.49% difference, p=0.0074)
For lung function change at week 50 vs. baseline:
·
·
·
There was a trend towards reduced FEV1 (L)decline (-12ml for AAT vs. -62ml for placebo, a 50 ml difference, p=0.0956)
There was a trend towards a reduced decline in FEV1% predicted (-0.1323% for AAT vs. -1.6205% for placebo, a 1.4882% difference, p=0.1032)
FEV1/SVC% rose significantly in AAT treated patients and decreased in placebo treated patients (0.61% for AAT vs. -1.07% for placebo, a 1.68% difference, p=0.013)
Additional data collected throughout the trial for exacerbation symptom score and well-being score. The changes in symptoms of dyspnea and well-being are suggested as those that most
influence the change in patients’ health, and quality of life status and determine the need for additional therapy. The results showed trends in favor of the AAT-treated group for both dyspnea and well-
being but were not statistically significant. The improvement in dyspnea and well-being further correlates with the fact that patients inhaling AAT had better preserved airflow than patients inhaling
placebo.
During March 2014, we initiated Phase II trials in the United States. The trial was completed in May 2016. This trial was intended to serve as a supplementary trial to the European Phase II/III
trial and was designed to incorporate parameters required by the FDA. This Phase II, double-blind, placebo-controlled study explored the ELF and plasma concentration as well as safety of Inhaled AAT
in AATD subjects. The subjects received one of two doses of Inhaled AAT or placebo. The study involved the inhalation of 80 mg or 160 mg of human AAT or placebo twice daily via the eFlow® device
for 12 weeks. Following the 12 week double blind period, the subjects were offered to participate in an additional 12 weeks open label period during which they receive only Inhaled AAT therapy. In
December 2015, we completed the enrollment of patients for the U.S. Phase II clinical trial, and in August 2016, we reported positive top-line results, according to which we met the primary endpoint.
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AATD patients treated with our Inhaled AAT product in such U.S. Phase II clinical trial, demonstrated a significant increase in endothelial lining fluid (ELF) AAT antigenic level compared to the
placebo group [median increase 4551 nM, p-value<0.0005 (80 mg/day, n=12), and 13454 nM, p-value<0.002 (160mg/day, n=12)]. These results are more than twice the increase of ELF antigenic AAT
level (+2600 nM) observed in Kamada’s previously completed intravenous (IV) AAT pivotal study (60mg/kg/week). Antigenic AAT represents the total amount of AAT in the lung, both active and
inactive. The study results also showed that our Inhaled AAT is the most efficient way of delivering therapeutic amounts of AAT to the primary sites of potential lung injury. In addition, ELF Anti-
Neutrophil Elastase inhibitory (ANEC) level also increased significantly [median increase 2766 nM, p-value<0.0005 (80mg/day) and 3557 nM., p-value<0.004 (160 mg/day)]. The increase in ELF ANEC
level was also more than twice that demonstrated in our previously completed IV AAT pivotal study. The ANEC level represents the active AAT that can counterbalance further damage by neutrophil
elastase.
The updated data included in our poster presentation of May 2017 demonstrated that ELF-AAT, neutrophil elastase (NE)-AAT and ANEC complexes concentration significantly increased in
subjects receiving the 80 mg and 160 mg doses, (median increase of 38.7 neutrophil migration (nM), p-value<0.0005 (80 mg/day, n=12), and median increase of 46.2 nM, p-value<0.002 (160 mg/day,
n=10)). This is a specific measure of the anti-proteolytic effect in the ELF and represents the amount of NE that was broken down by AAT. The increase in levels of functional AAT was six times higher
(160 mg per day) than is achievable with intravenous (IV) AAT. In addition, ELF NE decreased significantly. Also, the 80 mg data demonstrated a significant reduction in the percentage of neutrophils.
Finally, aerosolized M-specific AAT was detected in the plasma of all subjects receiving Inhaled AAT, consistent with what was seen in the Phase II/III clinical trial of our Inhaled AAT conducted in the
EU.
We filed the MAA for our Inhaled AAT for AATD during the first quarter of 2016 and in June 2017 we withdrew the MAA, as following extensive discussions with the EMA, we concluded that
the EMA did not view the data submitted as sufficient, in terms of safety and efficacy, for approval of the MAA, and that the supplementary data needed for approval required an additional clinical trial.
While the post-hoc data provided by us from the European clinical trial showed a statistically significant and clinically meaningful improvement in lung function, the EMA was of the opinion that an
overall positive conclusion on the effect of Inhaled AAT for AATD could not be reached based on that post-hoc analysis, and that the treatment of AATD patients with our Inhaled AAT product should be
further evaluated in the clinic in order to obtain comprehensive long-term efficacy and safety data. The EMA was of the opinion that the study failed to show beneficial effects in the population studied. In
addition, there were concerns about the tolerability and safety profile of the AAT, mainly in patients with severe lung disease. In addition, the EMA raised concerns about the high rate of patients with
antibodies (ADA) responding to AAT, which might reduce its effects or make patients more prone to allergic reactions, despite evidence that none of the patients with such ADA response had allergic
reaction nor a lower level of AAT in the serum.
When we presented the data from the European Phase II/III study to the FDA , the FDA expressed concerns and questions about that data, related to the safety and efficacy of Inhaled AAT for the
treatment of AATD and the risk/benefit balance to patients based on that data. The FDA’s questions and concerns need to be resolved before the agency would allow us to proceed with additional clinical
development of Inhaled AAT in the United States. In order to address the agency’s concerns and questions, in April 2017, we submitted to the agency the results of the U.S. Phase II data together with a
proposed Phase III synopsis. In July 2017, we submitted to the FDA for review a proposed pivotal Phase III protocol for our Inhaled AAT product. In August 2017, in response to the study protocol and
previous submission, the FDA issued a letter to us stating that it continues to have concerns and questions about the safety and efficacy of the Inhaled AAT. We are currently in discussions with the FDA
with respect to the pivotal Phase III study for Inhaled AAT for AATD, which is designed to address both FDA and EMA concerns regarding the safety and efficacy. The proposed Phase III pivotal study is
intended to treat AATD subjects with Inhaled AAT at a dose of 80 mg once daily for a period of two years, with a placebo arm at a 1:1 ratio. If FDA authorizes our IND, the study is planned to include
approximately 220 patients, and is expected to measure lung function as a primary endpoint and lung density as a secondary endpoint.
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Upon conclusion of these discussions and subject to FDA’s authorizing our IND, we intend to initiate the new pivotal Phase III clinical trial in the United States in the second half of 2018, and
resubmit the MAA after such clinical trial is successfully completed, with the data to be collected in such clinical trial.
Recombinant AAT
According to our strategic decision to focus on AATD, and in preparation for future increased demand for AAT resulting from greater awareness of AAT deficiency, as well as potential additional
indications for Alpha 1 Antitrypsin, which are currently in clinical development, we have initiated development activities in the recombinant human Alpha 1 Antitrypsin ("rhAAT") field.
To ensure the success of this project, we have previously developed analytical methods (physicochemical, biochemical, in-vitro, and in-vivo) that will help identify and characterize functional
rhAAT. In addition, we have established a significant understanding of a favorable expression system and growth conditions required to successfully develop an effective rhAAT and we are exploring
potential collaborations with third parties in the development of rhAAT.
AAT by Infusion for Treatment of Graft-Versus-Host Disease
GvHD is a common complication following an allogeneic tissue transplant. It is commonly associated with stem cell transplant, but the term also applies to other forms of tissue graft. Immune
cells (white blood cells) in the tissue (the graft) recognize the recipient (the host) as "foreign". The transplanted immune cells then attack the host's body cells.
GvHD occurs in 30-70% of patients who undergo a medical procedure of allogeneic hematopoietic stem cell transplantation (HSCT), usually as a treatment to leukemia or other blood cancer or
blood conditions. HSCT is a stem cell transplantation that is usually derived from an external (allogeneic) bone marrow donor. One of the most common and dangerous complications of HSCT is GvHD.
GvHD is expressed in damage to the recipients’ tissues including damage to the liver, gastrointestinal system, skin and mucosal tissues, and is a major cause of death in these patients.
Intravenously administered glucocorticoids, such as prednisone, are the standard treatment in acute GvHD and chronic GvHD. The use of these glucocorticoids is designed to suppress the T-cell-
mediated immune onslaught on the host tissues; however, in high doses, this immune-suppression raises the risk of infections and cancer relapse. In addition, more than 50% of patients do not respond
well to steroids and consequently have very low survival rates.
Preliminary human and animal studies indicate that AAT may reduce the severity of GvHD, which is one of the key, life threatening complications of allogeneic stem cell transplantation. GvHD
could result in significant damage to the recipients’ tissues including damage to the liver, gastrointestinal tract, skin and mucosal membranes. The immuno-modulatory effect of AAT may attenuate
inflammation by lowering levels of pro-inflammatory mediators such as cytokines, chemokines and proteases that are associated with this severe disease. GvHD is a disease of unmet medical need and
both the disease and current therapy options carry considerable side effects. Given the favorable safety profile of our intravenous AAT product, we will continue to support the clinical development of this
potential indication and for possible regulatory submission.
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The European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the EMA, has designated our proprietary human IV AAT as an orphan
medicinal product to treat GvHD. We received Orphan Drug designation from the FDA for our AAT by IV to treat GvHD. The orphan designation allows the awarded pharmaceutical company to benefit
from incentives offered by the European Union to develop the designated medicine for the rare indication.
In November 2016, we initiated a Phase II/III clinical trial in aGvHD in collaboration with Shire. This Phase II/III clinical trial was planned to be a two-part, multi-center, prospective study to
evaluate the safety and efficacy of our AAT IV as an add-on biopharmacotherapy to conventional steroid treatment in up to 168 patients with acute GvHD with lower gastrointestinal involvement (LGI-
aGvHD). However, in June 2017, Shire informed us of its decision not to continue with the study. As the result of this decision, the study was halted.
In January 2018, we announced a collaboration with the Mount Sinai Acute GvHD International Consortium (MAGIC) for the conduct of a clinical trial assessing the safety and preliminary
efficacy of our AAT product as preemptive therapy for patients at high-risk for the development of steroid-refractory acute GvHD (SR-aGvHD). The study will be conducted in five U.S. centers, all of
which are members of MAGIC, which consists of 23 Bone Marrow Transplantation (BMT) centers in the United States, Europe and Asia, and conducts clinical trials to prevent and treat GvHD following
BMT. This is an investigator-initiated study, co-funded by Mount Sinai and our company, and is sponsored by the Icahn School of Medicine at Mount Sinai (ISMMS). The study will be initiated in the
first quarter of 2018. This study replaces the previously-planned Phase II/III clinical trial that was designed to evaluate IV AAT as a first-line treatment for aGvHD patients.
The open-label, single-arm study will include 30 high-risk patients who will be treated with our IV AAT for 8 weeks with a follow-up period of one year after undergoing BMT. The primary
endpoint will measure the proportion of patients who develop SR-aGvHD by day 100 post-BMT. Other endpoints will include safety, severity of GvHD and mortality.
The Principal Investigator of the study is John Levine, M.D., M.S., Professor of Pediatrics and Medicine, Hematology and Medical Oncology at the Tisch Cancer Institute at ISMMS and Co-
Director of MAGIC. The laboratory aspects of the study will be led by James L.M. Ferrara, M.D., Professor of Pediatrics, Oncological Sciences and Medicine, Hematology and Medical Oncology at the
Tisch Cancer Institute at ISMMS, and Co-Director of MAGIC.
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The study is based on an innovative approach of early intervention driven by biomarkers. Drs. Ferrara and Levine have developed an algorithm to diagnose patients at risk for non-relapse
mortality on day seven following BMT. The MAGIC algorithm utilizes proprietary biomarkers for prediction of mortality risk. Non-relapse mortality is closely related to non-responsiveness to steroids,
which are the current standard of care for aGvHD. Early intervention, based on risk prediction and prior to the development of the clinical symptoms of aGvHD, could prevent patients from further
disease deterioration. To date, the MAGIC database includes data from over 2,500 BMT recipients. Pursuant to the agreement with ISMMS, we received the exclusive right to develop and commercialize
AAT for GvHD using the MAGIC biomarkers.
Further development of this indication would be subject to the trial results, while considering prospective development partners.
AAT for Treatment of Lung Transplantation Rejection
Lung transplantation rejection occurs when the recipient’s immune system attacks the transplanted lung resulting in destruction of the transplanted lung tissue. Around 20% of lung transplant
recipients will experience an episode of acute rejection within the first year and approximately 48% and 76% of the recipients will experience chronic rejection within five and 10 years respectively.
Chronic rejection is also known as BOS (Bronchiolitis Obliterans Syndrome).
A lung transplant is considered only for people with severe, end-stage lung disease, when patients will most likely die without the surgery and no other options are available. The most common
lung diseases for which people undergo lung transplant are Chronic Obstructive Pulmonary Disease, Idiopathic pulmonary fibrosis, cystic fibrosis and Idiopathic Pulmonary Arterial Hypertension.
To protect the new lung, patients are prescribed a variety of medications which suppress the body's natural immune response. These medications are called "immunosuppressants," and they are
intended to trick the immune system into believing that the new organ is not foreign, and therefore it is not attacked. After transplantation, the patient will have to take immunosuppressant medications for
the rest of the patient's life.
In 2015, we entered into collaboration with Shire on a Phase II clinical trial of our proprietary alpha-1 antitrypsin (AAT) treatment for the prevention of lung transplantation rejection that is
currently performed in Israel. Under the agreement, Shire and we collaborate in the development and funding of the study.
This Phase II study was initiated in April 2016 and in January 2018, we reported the interim results for such Phase II study. Topline results are expected to be published in the second half of 2019.
The study is a randomized, open-label, single-site study of 30 lung transplant recipients to evaluate the safety and efficacy of IV AAT on top of standard-of-care (SOC) versus SOC. The study is
randomized 2:1 with 20 patients in the treatment group receiving IV AAT treatment every other day for 14 days, then once every two weeks until week eight, followed thereafter by monthly treatments.
The ten patients in the control group will be treated with SOC, which includes systemic corticosteroids and immunosuppressants. Following one year of AAT treatment, there will be a one-year follow-up.
The primary endpoints of the study include safety and tolerability, the incidence of acute lung transplantation rejection and changes in Forced Expiratory Volume (FEV1) from baseline and overall effect
(a measure of Bronchiolitis Obliterans (chronic rejection)). Additional endpoints measured will include various inflammatory biomarkers and functional capacity.
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The principal investigator in this study is Prof. Mordechai R. Kramer, M.D., Director of the Institute of Pulmonary Medicine, Rabin Medical Center - Beilinson Hospital. Prof. Kramer, a
renowned expert in pulmonary care and a top specialist in his field, is a full Professor at Tel Aviv University, Sackler Faculty of Medicine. He completed several fellowships in the U.S. in pulmonary care
and lung transplantation, and has published many articles in leading scientific publications.
In May 2017, the last patient of the 30 patients to be recruited entered the study and began treatment. In January 2018, we reported interim results which summarize data from the first six months
of treatment for the initial 16 patients in the study. Ten of these 16 patients were in the AAT+SOC group, and six were in the SOC arm. To date, six patients have died (four patients in the AAT+SOC arm,
and two in the SOC group) from common transplant-related complications unrelated to treatment with IV AAT.
Out of the 10 total patients who lived throughout the six-month treatment period, four experienced acute rejection post transplantation, but survived and their situation improved and stabilized.
Two of the patients who experienced the acute rejections were in the AAT+SOC arm, but their situation resolved without the need to change treatment; the other two patients were in the SOC group and
their situation resolved, with one of them changing treatment. Moreover, pulmonary function, which is a key indicator of acute or chronic rejection, improved and was found to be stable in all 10 patients
who are alive following six months of treatment.
Our AAT demonstrated a favorable safety and tolerability profile, consistent with the results observed in previous clinical studies in different indications. None of the adverse events (AEs) or
serious adverse events (SAEs) observed to date were considered to be related to treatment with IV AAT. During the six months of treatment, the six patients in the SOC group had a total of 28 AEs, while
the 10 patients in the AAT+SOC arm had a total of 36 AEs. This represents a rate of 3.6 AEs and 2.5 AEs per 100 days of treatment in the SOC and AAT+SOC arms, respectively. Out of the 28 AEs in the
SOC group, four were SAEs, while out of the 36 AEs in the AAT+SOC arm, three were SAEs. This represents a rate of 0.51 SAEs and 0.2 SAEs per 100 days of treatment in the SOC and AAT+SOC
arms, respectively.
AAT by Infusion for Treatment of Newly Diagnosed Type-1 Diabetes
Type 1 Diabetes is an autoimmune disease in which the pancreatic beta cells responsible for secretion of insulin are attacked and destroyed by the immune system. According to estimates by the
U.S. Centers for Disease Control, more than 10 million people throughout the world suffer from Type-1 Diabetes with 100,000 new patients diagnosed annually. According to estimates by the American
Association for Type-1 Diabetes, approximately three million people in the United States suffer from Type-1 Diabetes, with 30,000 new patients diagnosed annually.
Studies have demonstrated that even though the level of AAT protein in Type-1 Diabetes patients may be normal, the activity of the AAT protein in these patients is significantly lower than in
healthy people. Because AAT has proven anti-inflammatory responses, we believe that treatment by AAT protein in the initial stages after diagnosis of Type-1 Diabetes may prevent or may delay the
inflammation that is caused by the autoimmune destruction of the pancreatic cells. As a result, we believe that AAT therapeutics may slow the progression of the development of newly diagnosed Type-1
Diabetes and improve prognosis.
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In November 2017, we reported topline results of a phase II clinical trial. The 70 patients enrolled in the study, ranging in age from 8 to 25 years old, and recruited within 100 days of diagnosis of
T1D, were randomized to three treatment groups in a 1:1:1 ratio; placebo and two doses of AAT, 60 mg/kg or 120 mg/kg. The study’s duration was 56 weeks and included three treatment periods. During
the first 12 weeks, a once-weekly treatment was given, followed by 8 weeks of treatment given every two weeks, then a follow-up period of 26 weeks, followed by a once-weekly treatment given for 6
weeks, and a final 4-week follow-up period. Study endpoints included beta cell function assessment as measured by change in C-peptide parameters, glycemic control represented by HbA1C levels and
insulin daily dose. The key results for the 12- to 18-year-old patient subgroup treated included:
· Better preservation of beta-cell function, demonstrated as a smaller decline of the average (± SEM) Area Under the Curve (AUC) of stimulated (MMTT) C-peptide secretion over time (- 0.18 ±
0.15nmol/L for AAT 120 mg/kg, -0.47 ±0.13 nmol/L for 60 mg/kg, and -0.34 ±0.10 nmol/L for the placebo group; p =0.543), suggesting a slower decline in pancreatic function for the 120 mg/kg
treatment arm. Similar differences were noted for Cmax (defined as maximum or peak serum concentration).
· Lower average HbA1c (AAT 120 mg/kg: 6.66±0.32%, AAT 60 mg/kg: 7.85±0.45%, placebo: 8.29±0.52%, p=0.052, in addition the p-value of the comparison between AAT 120 mg/kg and
placebo was p=0.048) and a higher percentage of patients who achieved the clinically meaningful target of HbA1c ≤7% (AAT 120 mg/kg: 70%, AAT 60 mg/kg: 29%, placebo: 25%, p=0.073).
· In a post-hoc analysis of insulin daily dose intake a beneficial favorable effect trend was found in the AAT 120 mg/kg treatment group versus placebo, p=0.086.
We are currently seeking a strategic partner for collaboration in further product development.
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Strategic Partnerships
We currently have strategic partnerships with a number of different companies regarding the development and/or distribution of our products in both the Proprietary Products and Distribution
segments. Certain of the strategic partnerships relating to our Proprietary Products segment are discussed below.
Shire (Glassia)
On August 23, 2010, we entered into a strategic partnership with Baxter International Inc. ("Baxter"). During 2015, Baxter assigned all its rights under the partnership agreement to Baxalta US
Inc. ("Baxalta"), an independent public company which spun- off from Baxter. In 2016, Shire completed the acquisition of Baxalta, and as a result, all Baxalta's rights under the partnership agreement
have been assigned to Shire.
The partnership arrangement with Shire includes three main agreements: (1) a distribution agreement, pursuant to which Shire is the sole distributor of Glassia in the United States, Canada,
Australia and New Zealand; (2) a licensing agreement, which grants Shire licenses to use our knowledge and patents to produce, develop and sell Glassia and other products administered by transfusion;
and (3) an agreement for Shire to supply us with fraction IV plasma, a plasma derivative, produced by Shire, as discussed under “— Manufacturing and Supply — Raw Materials — Fraction IV plasma
for Glassia.” As between us and Shire, we retain all rights, including distribution rights, to any inhaled formulation of AAT in development, including Inhaled AAT for AATD. On October 5, 2016, we
signed a fifth amendment to the distribution agreement with Shire to extend the period of minimum purchases by Shire of Glassia until the end of 2020 and increase the minimum purchases under the
distribution agreement. Following the amendment, the minimum aggregate revenue for Glassia under such extended agreement for the years 2018 to 2020 is expected to reach approximately $177 million
and may be expanded to $228 million during that period, excluding any potential royalty payments under the licensing agreement, which are not expected to begin prior to 2021.
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Sales to Shire accounted for approximately 59%, 52% and 37% of our total revenues for the years ended December 31, 2017, 2016 and 2015, respectively.
Distribution Agreement
Pursuant to the distribution agreement, we received an upfront and milestone payments of $25 million in total related to distribution rights. Additionally, Shire is obligated to purchase a minimum
amount of Glassia per year until the end of 2020. Pursuant to Shire’s minimum purchase obligations, from 2017 until the end of 2020, we are entitled to receive minimum revenues of between $56.8
million and $63.1 million per year from Shire. We expect that from 2021, Shire will start marketing Glassia in the United States to be produced at its production facility and pay us royalties, in accordance
with the terms of the technology license agreement. According to the terms of the distribution agreement, following its compliance with its purchasing obligations until the end of 2020, Shire will have no
further obligation to purchase a minimum amount of Glassia; however, Shire’s failure to purchase a specified minimum amount of Glassia over a period of 24 consecutive months until the expiration of
the agreement provides us with the right to terminate the agreement. Shire is also obligated to fund required Phase IV clinical trials related to Glassia up to a specified amount. If the costs of such clinical
trials are in excess of this amount, we have agreed to fund a portion of the costs. We do not expect that the cost of the trials will exceed the specified amount. In May 2016 and June 2017, we received
milestone payments from Shire as a result of Shire achieving an undisclosed sales milestone for Glassia. We have committed to reimburse Shire for its Glassia marketing efforts up to a limited amount
during the years 2017-2020.
The distribution agreement expires in 2040. In addition to customary termination provisions, either party may terminate the agreement, subject to certain exceptions, in whole or solely with
respect to one or more countries covered by the distribution agreement, if regulatory approval in one or more countries covered by the distribution agreement is withdrawn or rejected and not reversed.
Shire has the right to terminate the agreement, upon prior written notice and after a period of time, in the event that Glassia is determined to materially infringe upon a third party’s intellectual property
rights. In addition to the minimum purchase termination right discussed above, we have the right to terminate the agreement upon prior written notice if Shire infringes upon our intellectual property.
Following termination of the agreement, Shire is obligated to cease marketing, promoting or otherwise using Glassia and, at our election, sell all remaining inventory of Glassia in the market or
back to us at the relevant purchase price.
Technology License Agreement
The technology license agreement provides an exclusive license to Shire, with the right to sub-license to certain manufacturing parties, of our intellectual property and know-how regarding the
manufacture and additional development of Glassia for use in Shire’s production and sale of Glassia in the United States, Canada, Australia and New Zealand. Shire agreed to pay us royalties at the rates
specified in the agreement, which are in the low double digits during the first 15 years of the agreement and decreasing to less than 10% for the remainder of the period, once it begins to sell Glassia of its
own production. We do not expect that such production will begin prior to 2021. The technology license agreement sets forth a minimum amount of royalty payments of $5.0 million required to be made
by Shire per year beginning on the first year of commercial sales of Glassia produced by Shire.
Pursuant to the technology license agreement, we are entitled to receive payments for the achievement of certain milestones for an aggregate of up to $20.0 million, of which we have already
received $14.5 million. Of the milestone payments, $15.0 million are development-based milestones related to the transfer of technology to Shire and $5.0 million are sales-based milestones.
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The intellectual property rights for any improvements on the manufacturing process or formulations that we disclose to Shire belong to the party that develops the improvements, with each party
agreeing to cross-license the developed improvements to the other party. We retain an option to license any intellectual property developed by Shire under the agreement that is not considered an
improvement on the licensed technology. Additionally, Shire owns any intellectual property it develops using the licensed technology for new indications for the intravenous AAT product, for which we
retain an option to license at rates to be negotiated. Any technology related to new indications for the intravenous AAT product developed by us during the royalty payments period will be part of the
licensed technology covered by the technology license agreement.
The technology license agreement expires in 2040. Either party may terminate the agreement, in whole or solely with respect to one or more countries covered by the distribution agreement,
pursuant to customary termination provisions. Shire also has the right to terminate the agreement, upon prior written notice, in the event that: (i) our manufacturing process technology for Glassia is
determined to materially infringe upon a third party’s intellectual property rights, and we have not obtained a license to such third party’s intellectual property or provided an alternative non-infringing
manufacturing process; (ii) there are certain decreases in Glassia sales in the United States unless such decreases are due to transfers to Inhaled AAT for AATD; or (iii) the regulatory approval process in
the United States has been withdrawn or rejected as a result of our inaction or lack of diligent effort, provided such withdrawal or rejection was not primarily caused by the breach by Shire of its
obligations. We have the right to terminate the agreement, upon prior written notice: (i) if Shire contests or infringes upon our intellectual property; (ii) if regulatory approval in one or more countries
covered by the technology license agreement is withdrawn or rejected and not reversed, provided it was not primarily caused by the breach by us of our obligations; (iii) in the event that Glassia produced
by Shire, other than as a result of our manufacturing process technology, is determined to materially infringe upon a third party’s intellectual property rights, provided that the termination right is limited
only to the country in which such judgment is binding; or (iv) if the first sale of Glassia produced by Shire did not occur by June 15, 2017 and Shire has not used commercially reasonable efforts to sell by
that date. Following any termination, other than expiration of the agreement, all licensed rights will revert to us. Upon expiration of the agreement, we are obligated to grant to Shire a non-exclusive,
perpetual, royalty free license.
Chiesi Farmaceutici S.p.A ("Chiesi") (Inhaled AAT for AATD product)
On August 2, 2012, we entered into an exclusive distribution agreement with Chiesi, pursuant to which we granted Chiesi the exclusive right to commercialize Inhaled AAT for AATD in the
European Union and Turkey, as well as certain other European and Asian countries, including certain ex-Soviet Union countries.
In November 2017, we and Chiesi mutually agreed to terminate the exclusive distribution agreement. Following the withdrawal of the MAA for the Inhaled AAT for AATD product candidate
with the EMA, a European distribution agreement within the pact’s defined timeframe was not warranted. We maintain full, worldwide commercial rights in Inhaled AAT for AATD. There were no
financial implications related to the termination of such agreement and we are not required to return any payment previously granted to us by Chiesi in the scope of the exclusive distribution agreement
which was terminated.
PARI
On November 16, 2006, we entered into a license agreement with PARI (the “Original PARI Agreement”) regarding the clinical development of an inhaled formulation of AAT, including Inhaled
AAT for AATD, using PARI’s “eFlow” nebulizer. Under the Original PARI Agreement, we received an exclusive worldwide license, subject to certain preexisting rights, including the right to grant sub-
licenses, to use the “eFlow” nebulizer, including the associated technology and intellectual property, for the clinical development, registration and commercialization of inhaled formulations of AAT to
treat AATD and respiratory deterioration, and to commercialize the device for use with such inhaled formulations. The agreement also provided for PARI’s cooperation with us during the pre-clinical
phase and Phase I clinical trials of inhaled formulations of AAT, where each of us was responsible for developing and adapting our own product and bore the costs involved.
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Pursuant to the Original PARI Agreement, we agreed to pay PARI royalties from sales of inhaled formulations of AAT, after certain deductions, at the rates specified in the agreement. We have
agreed to pay PARI tiered royalties ranging from the low single digits up to the high single digits based on the annual net sales of inhaled formulations of AAT for the applicable indications. The royalties
will be paid for each country separately, until the later of (1) the expiration of the last of certain specified patents covering the “eFlow” nebulizer, or (2) 15 years following the first commercial sale of an
inhaled formulation of AAT in that country (the “PARI royalties period”). During the PARI royalties period, PARI is obligated to pay us specified percentages of its annual sales of the “eFlow” nebulizer
for use with inhaled formulations of AAT above a certain threshold defined in the agreement and after certain deductions. On February 21, 2008, we entered into an addendum to the Original PARI
Agreement (together with the Original PARI Agreement, the “PARI Agreement”), which extended the exclusive global license granted to us to use the “eFlow” nebulizer, including the associated
technology and intellectual property, for the clinical development, registration and commercialization of inhaled formulations of AAT for two additional indications of lung disease, namely cystic fibrosis
and bronchiectasis. At present, the development of cystic fibrosis and bronchiectasis products is suspended as we prioritize other products. Pursuant to the addendum, each party will be responsible for
developing and adapting its own product for the additional indications and will bear the costs involved. Additionally, we and PARI will supply, each at its own expense, inhaled formulations of AAT and
the “eFlow” nebulizers, respectively, and in the quantities required for all phases of clinical studies worldwide. In addition, PARI will provide to us, at its expense, technical and regulatory support
regarding the “eFlow” nebulizer. Sales of the inhaled formulation of AAT for the additional indications will be added to sales of the first two indications covered by the original agreement as the basis for
calculating the royalties to be paid by us to PARI.
The PARI Agreement expires when the PARI royalties period ends. Either party can terminate the PARI Agreement upon customary termination provisions. Additionally, upon the occurrence of
any one of the following events, PARI has the right to negotiate with us in good faith about whether to continue our collaboration: (i) PARI’s costs of the required clinical trials exceed a certain amount,
unless we or a third party incurs such expenses on behalf of PARI; (ii) an inhaled formulation of AAT is not successfully registered with any regulatory authorities by 2016; (iii) there are no commercial
sales of inhaled formulations of AAT within a certain period after successful registration with any regulatory authority; or (iv) we cease development of inhaled formulations of AAT for a certain period of
time. If, within 180 days of PARI’s request to negotiate, we do not agree to continue the collaboration, PARI has the option either to render the license they grant to us non-exclusive or to terminate the
agreement. We have the right to terminate the agreement, upon prior written notice, (i) in the event that the “eFlow” nebulizer is determined to infringe upon a third party’s intellectual property rights, (ii)
an injunction barring the use of the “eFlow” nebulizer has been in place for a certain period of time, (iii) a clinical trial for inhaled formulations of AAT fails as a result of, after a cure period, the “eFlow”
nebulizer not conforming to specifications or PARI’s inability to supply the “eFlow” nebulizer; or (iv) failure by PARI to register the “eFlow” nebulizer within a certain period of time after receiving
Phase III results for Inhaled AAT for AATD.
Following any termination, all licensed rights will revert to PARI, unless we terminate the agreement as a result of PARI’s bankruptcy, payment failure or material breach, in which case we retain
the license rights to the “eFlow” nebulizer as long as we continue making royalty payments.
In addition, on February 21, 2008, we signed a commercialization and supply agreement with PARI that provides for the supply of the “eFlow” nebulizer and its spare parts to patients who are
treated with the inhaled formulation of AAT, either through its own distributors, our distributors or independent distributors in countries where PARI does not have a distributor. The commercialization
and supply agreement expires upon the earlier of (1) the end of four years from (x) the end of the last PARI royalties period, or (y) the termination of the PARI Agreement by one party due to the other
party declaring bankruptcy, failing to make a payment after a 30-day cure period or breach of a material provision after a 30-day cure period, or (2) the termination of the PARI Agreement pursuant to its
terms, other than for reasons as previously described, in which case the commercialization and supply agreement terminates simultaneously with the PARI Agreement provided that PARI ensures
availability of the “eFlow” nebulizer and its associated spare parts and service to anyone being treated with the inhaled formulation of AAT at the time of such termination, for the warranty period of the
device or for a longer period, if required by the applicable law or the relevant regulatory authority.
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Kedrion (KamRAB)
On July 18, 2011, we signed an agreement with Kedrion, an international pharmaceutical company engaged in the manufacture of life saving drugs based on human plasma which complement
our products, and which are marketed in Europe, the United States and approximately 40 other countries worldwide. The agreement provides for exclusive cooperation on completing the clinical
development, and marketing and distribution of our anti-rabies pharmaceutical, KamRAB, in the United States, if the product is approved. Pursuant to the agreement, Kedrion will bear all the costs of the
Phase III clinical trials in the United States of our product for rabies. Costs related to any Phase IV clinical trials, if required, and the FDA Prescription Drug User fee that is required for all FDA new drug
approvals, will be divided equally between us and Kedrion. An addendum to the agreement was executed dated as of October 15, 2016, with respect to the performance of a safety clinical trial for the
treatment of pediatric patients which we intend to initiate in the United States. According to such addendum, Kedrion and we agreed to equally share the cost of such trial.
In 2014, the Phase III trial was completed and successfully met the trial’s primary endpoint of non-inferiority when measured against an IgG reference product, and in September 2016, the BLA
was submitted to the FDA. In August 2017, we received FDA approval of anti-rabies immunoglobulin as a post-exposure prophylaxis against rabies infection. We expect to launch KamRAB in the United
States in first half of 2018 under the trademark "KEDRAB". See “Item 4. Information on the Company — immunoglobulins — KamRAB”.
The agreement provides exclusive rights to Kedrion to market and sell KEDRAB in the United States. We retain intellectual property rights to KamRAB. Kedrion is obligated to purchase a
minimum amount of KEDRAB per year during the term of the agreement.
The term of the agreement is for six years following the receipt of FDA approval, subject to Kedrion’s option to extend the agreement by two years. In addition to customary termination
provisions, either party can terminate the agreement for any reason prior to the commencement of clinical trials for FDA approval. Kedrion also has the right to terminate the agreement, upon prior written
notice, (i) for any reason after receipt of FDA approval, (ii) in the event that the FDA Biologics License Application is suspended or revoked and cannot be reinstated within a certain period of time, or
(iii) a major regulatory change occurs that materially and adversely increases the clinical trial costs. We have the right to terminate the agreement in the event that (i) a major regulatory change occurs that
materially and adversely increases the manufacturing costs of KEDRAB, (ii) a major regulatory change occurs that poses considerable difficulties on submission of an application for FDA approval or (iii)
clinical trials are not initiated within a certain time after either receipt by Kedrion of enough product or FDA approval to begin clinical trials.
Manufacturing and Supply
We have a production plant located in Beit Kama, Israel, which we believe is fully cGMP compliant. We operate the main production facility on schedules so that at any time the facility is
assigned to produce only one product. The division of facility time among the various products is determined based on orders received, sales forecasts and development needs. During 2014, we
completed a new logistic facility in our plant in Beit Kama that will support our activities during the coming years. During each year we have routine maintenance shut downs of our plant, which may last
up to a few weeks.
Our production plant passed inspection by the FDA in 2010, and our plant and laboratories also successfully passed a quality assurance audit by the Russian Ministry of Health and similar
authorities in Brazil, Kenya and Mexico. In July 2011, a cGMP audit was conducted by the IMOH, following which the plant’s main production facility was reapproved, as well as the new facility to
produce our snake bite antiserum product, which was planned and constructed between the years 2009 and 2011 with IMOH funding and began operating in August 2011. In each of July 2013 and
February 2016, the IMOH completed additional successful cGMP audits of our facility and concluded that we comply with cGMP requirements of the IMOH. In February 2017, the EMA completed a
successful cGMP audit of our facility in connection with our Inhaled AAT Product with no critical observations, and in March 2017, the FDA completed a successful audit of our facility in connection
with our products Glassia and KEDRAB with no critical observations.
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Any changes in our production processes for our products must be approved by the FDA and/or similar authorities in other jurisdictions. In 2014, as part of our on-going effort to increase
efficiency and profitability, we received approval from the FDA to make changes to the production processes for Glassia, which scale-up the output of our manufacturing facility, and began to produce
Glassia using the improved processes.
Raw Materials
The main raw materials in our Proprietary Products segment are plasma and fraction IV. We also use other raw materials, including both natural and synthetic materials. We purchase raw
materials from suppliers who are regulated by the FDA, EMA and other regulatory authorities. Our suppliers are approved in their countries of origin and by the IMOH. The raw materials must comply
with strict regulatory requirements. We require our raw materials suppliers to comply with the cGMP rules, and we audit our suppliers from time to time. We are dependent on the regular supply and
availability of raw materials in our Proprietary Products segment.
Other than Shire, in the years ended December 31, 2017, 2016 and 2015, there were two suppliers who accounted for 10% or more of the total purchases of raw materials in our Proprietary
Products Segment. We maintain relationships with several suppliers in order to ensure availability and reduce reliance on specific suppliers. We are dependent, however, on a number of suppliers who
supply specialty ancillary products prepared for the production process, such as specific gels and filters. See “Item 3. Key Information — D. Risk Factors — We would become supply-constrained and our
financial performance would suffer if we were unable to obtain adequate quantities of source plasma or plasma derivatives or specialty ancillary products approved by the FDA, the EMA or the regulatory
authorities in Israel, or if our suppliers were to fail to modify their operations to meet regulatory requirements.”
In the years ended December 31, 2017, 2016 and 2015, we incurred $19.9 million $18.4 million and $19.0 million of expenses for the purchase of raw materials, respectively.
Fraction IV Plasma for Glassia
On August 23, 2010, in conjunction with the cooperation arrangement with Shire, we signed an agreement with Shire for the supply of fraction IV plasma for use in the production of Glassia to
be sold in the United States. Under this agreement, Shire also supplies us with fraction IV plasma to continue the development and trials of Glassia and for the production, sale and distribution of Glassia
in jurisdictions other than those which are covered under the exclusive distribution agreement. Shire receives no payment for the supply of fraction IV plasma to be used by us for the manufacture of
Glassia to be sold to Shire. If we require fraction IV for other purposes, we are entitled to purchase it from Shire at a predetermined price. While we are dependent on Shire for the supply of fraction IV
plasma, Shire is currently dependent on us to produce Glassia for sale in the United States, as it does not have its own FDA approved production facility for Glassia. We assume that Shire will have an
FDA approved production facility by 2021. The supply agreement terminates on August 23, 2040, subject to an option for earlier termination in the event of a material breach.
In December 2012, we signed an additional agreement with Shire to supply additional fraction IV plasma manufactured in its Vienna plant to be used as the raw material in the production of our
AAT product. Shire is obligated to make available to us yearly minimum quantity of fraction IV plasma. The agreement remains in effect until December 31, 2021, subject to earlier termination in the case
of a breach, and may be renewed for two consecutive two year periods upon mutual agreement of both parties. Either party may terminate the agreement for any reason with twelve months prior written
notice to the other party, provided that as a condition to such termination by Shire, Shire is obligated to provide us, upon our request, with fraction IV plasma in the amount equivalent to the previous
year’s total amount of fraction IV plasma sold to us in addition to the fraction IV plasma to be sold during the last year of the agreement.
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We have an additional fraction IV plasma supplier, which supplies us with fraction IV plasma that is used for production of Glassia marketed in non-U.S. countries. We are in the process of
entering into long-term supply agreements for fraction IV plasma with additional companies.
Hyper-immune Plasma
We have a number of suppliers in the United States for hyper-immune plasma with which we have long-term supply agreements. Hyper-immune plasma is used for the production of KamRAB
and KamRho(D). In addition to long-term supply agreements, we work to secure availability of hyper-immune plasma on an annual basis by providing forecasts to our suppliers based on our customers’
actual and forecasted orders. We continue to seek to enter into long-term supply agreements for hyper-immune plasma with additional plasma-collection companies.
Research and Development
Our research and development activity in the Proprietary Products segment includes conducting pre-clinical and clinical trials, development activities in the recombinant human Alpha 1
Antitrypsin ("rhAAT") field, advanced understanding of the mechanism of action of AAT, improving existing products and processes, development work at the request of regulatory authorities and
strategic partners, as well as communication with regulatory authorities related to our commercial products as well as clinical programs. We incurred approximately $12 million, $16.2 million and $16.5
million research and development expenses in the years ended December 31, 2017, 2016 and 2015, respectively.
Marketing and Distribution
In the Proprietary Products segment, we receive orders for plasma-derived protein therapeutics and, other than for Glassia, requests for participation in tenders for the supply of plasma-derived
protein therapeutics from potential distributors and from existing distributors. We sell Glassia to Shire and to other distributors in additional Non-U.S. countries.
For our other products, we market, in most cases, by means of agreements with local distributors in each country through a tender process and the private market. The tender process is conducted
on a regular basis by the distributors, sometimes on an annual basis. For existing customers, our existing relationship does not guarantee additional orders from the same customers in these tenders. The
decisive parameter is generally the price proposed in the tender. The distributor purchases plasma-derived protein therapeutics from us and sells them to its customers (either directly or by means of sub-
distributors). In most cases, we do not sign agreements with the end users, and as such, we do not fix the price to the end user or its terms of payment and are not exposed to credit risks of the end users. In
the vast majority of cases, our agreements with the local distributors award the various distributors exclusivity in the distribution of our plasma-derived protein therapeutics in the relevant country. The
distribution agreements are, in most cases, made for a specific initial period and are subsequently renewed for one-year periods, where the parties have the right to cancel or renew the agreements with
prior notice of a number of months. In these markets, we do not actively participate in the marketing to the end users, except for supplying marketing assistance where the cost is negligible or participation
in marketing costs as a part of incentives for distributors. In Israel, we market our plasma-derived protein therapeutics independently to the end user, healthcare providers and medical centers or through a
partner company that specializes in the supply of equipment and pharmaceuticals to healthcare providers.
Most of our sales outside of Israel are made against open credit and some in documentary credit or cash in advance. Most of our sales inside Israel are made against open credit or cash. The credit
given to some of our customers abroad (except for sales in documentary credit or cash) is mostly secured by means of a credit insurance policy.
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In the Distribution segment, we market our products in Israel to health maintenance organizations and hospitals on our own or by our third party logistic associates. We sell our Distribution
segment products through offers to participate in public tenders that occur on an annual basis or through direct orders. The public tender process involves health maintenance organizations and hospitals
soliciting bids from several potential suppliers, including us, and selecting the winning bid based on several attributes, whereas the primarily attributes are, price and availability. The annual public tender
process is also used by our existing customers to determine their suppliers. As a result, our existing relationships with customers in our Distribution segment do not guarantee additional orders from such
customers year to year.
We have distribution agreements with each of our two largest suppliers in our Distribution segment to be their exclusive distributor in Israel for a number of their manufactured products;
however, we purchase our Distribution segment products from our suppliers on a purchase order basis. We work closely with our suppliers to develop annual forecasts, but these forecasts do not obligate
our suppliers to provide us with their products. Additionally, one of our suppliers has the right to convert the agreement into a non-exclusive agreement or terminate the agreement if we do not meet our
annual forecasts.
Customers
For the year ended December 31, 2017, sales to Shire and Kupat Holim Clalit, an Israeli healthcare provider, accounted for 59% and 9%, respectively, of our total revenues. For the year ended
December 31, 2016, sales to Shire and Kupat Holim Clalit accounted for 52% and 13%, respectively, of our total revenues. For the year ended December 31, 2015, sales to Shire and Kupat Holim Clalit
accounted for 37% and 15%, respectively, of our total revenues. No other customer accounted for greater than 10% of our total revenues in the year ended December 31, 2017, 2016 and 2015.
Shire is our major customer in the Proprietary Products segment. Our other customers in the Proprietary Products segment are our distributors in Brazil, Argentina, Russia, Thailand and India, as
well as healthcare providers and medical centers in Israel. In other geographies, most of the sales of our products are conducted through local distributors. These arrangements are further described above
under “— Marketing and Distribution.”
Our primary customers in the Distribution segment are health maintenance organizations and hospitals in Israel, including Kupat Holim Clalit and Kupat Holim Maccabi.
Competition
The worldwide market for pharmaceuticals in general, and biopharmaceutical and plasma products in particular, has in recent years undergone a process of mergers and acquisitions among
companies active in such markets. This trend has led to a reduction in the number of competitors in the market, but the strengthening of the remaining competitors, mainly for specific immunoglobulin
products.
Proprietary Products Segment
We believe that there are two to four large competitors for each of our products in the Proprietary Products segment. These large competitors include CSL Behring Ltd., Grifols S.A., which
acquired a previous competitor, Talecris Biotherapeutics, Inc. in 2011, and Kedrion. We have not seen significant changes in the activities of our competitors in recent years. Additionally, our strategic
alliance with Shire in the United States has strengthened our AAT competitive positioning in the market.
Our large competitors have advantages in the market because of their size, financial resources, markets and the duration of their activities and experience in the relevant market, especially in the
United States and countries of the European Union. Some of them have an additional advantage regarding the availability of raw materials, as they fractionate plasma internally and own plasma collection
centers and/or companies that collect or produce raw materials such as plasma.
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The following describes details known to us about our most significant competitors for each of our main Proprietary Products segment products.
Glassia. We believe that Glassia has two main competitors: Grifols and CSL. We estimate that Grifols’ AAT by infusion product for the treatment of AATD, Prolastin, accounts for at least 50%
market share in the United States and more than 70% of sales worldwide, and until 2015 it was the only AAT product that was approved for sale in both – key European countries and the United States. In
September 2017 Grifols announced that the FDA approved a liquid formulation of its AAT product. CSL’s AAT by IV product, Zemaira, is mainly sold in the United States, and during 2015 received
centralized marketing authorization approval in the European Union. CSL launched the product in few selected EU markets during 2016 under the brand name Respreeza. Apart from its sales of the past
Talecris product, Grifols is also a local producer of an additional AAT product, Trypsone, which is marketed in Spain and in some Latin American countries, including Brazil. While Shire is our strategic
partner for sales of Glassia, it also serves existing patients in the United States with its own proprietary product, Aralast. As far as we know Shire is currently proactively marketing only Glassia in the
United States, while maintaining existing patients on Aralast. In addition, we are aware of a smaller local producer of AAT in the French market, Laboratoire Français du Fractionnement et des
Biotechnologies, S.A ("LFB"). We do not believe any new suppliers are expected to enter the United States market for AAT by infusion in the near future. As part of the approval of our competitors’
intravenous AAT products for the treatment of AATD, they (like us) were required by the FDA to conduct Phase IV clinical trials aimed to collect efficacy data. CSL has released results from its Phase IV
trial. As far as we know those results were not accepted by the FDA as prove of required efficacy. To the best of our knowledge, to date, our other competitors have not completed their trials or their
results have not been published.
KamRAB. We believe that there are two main competitors for this anti-rabies product worldwide: Grifols, whose product we estimate comprises over 90% of the anti-rabies market in the United
States, and CSL, which sells its anti-rabies product in Europe and elsewhere. Sanofi Pasteur, the vaccines division of Sanofi S.A., has a product registered for the United States market, but the product is
primarily sold in Europe and not currently sold in significant quantities in the United States. There are a number of local producers in other countries that make similar anti-rabies products. Most of these
products are based on equine serum, which we believe results in inferior products, as compared to products made from human plasma.
KamRho(D). While Kedrion is one of our strategic partners for KamRAB, it is also one of our competitors for this product. In addition to its sales in the United States, Kedrion also markets a
competing product in Italy and has begun to expand into other markets. We believe there are three additional main suppliers of competitive products in this market: Aptevo, Grifols and CSL. There are
also local producers in other countries that make similar products mostly intended for local markets.
Distribution Segment
We believe that there are a number of companies active in the Israeli market distributing the products of several manufacturers whose comparable products compete with our products in the
Distribution segment. In the Plasma area, these manufacturers include Grifols, Shire, CSL, Omrix Biopharmaceuticals Ltd. (a Johnson & Johnson company) and Emergent BioSolutions, while in other
specialties we may be competing against products produced by some of largest pharmaceutical manufacturers in the world, such as, Novartis AG, AstraZeneca AB, Sanofi UK and GlaxoSmithKline.
These competing manufacturers have advantages of size, financial resources, market share, broad product selection and extensive experience in the market, although we believe that we have greater
expertise in the Israeli market. Each of these competitors sells its products through local representatives in Israel.
Government Regulation
Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture,
quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of products such as
those we sell and are developing. Except for compassionate use or non-registered named-patient cases, any pharmaceutical candidate that we develop must be approved by the FDA before it may be
legally marketed in the United States and by the appropriate foreign regulatory agency before it may be legally marketed in foreign countries.
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U.S. Drug Development Process
In the United States, pharmaceutical products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act and other laws, including, in the case of biologics, the Public Health
Service Act. All of our products for human use and product candidates in the United States, including Glassia, are regulated by the FDA as biologics. Biologics require the submission of a Biologics
License Application (“BLA”) and approval or license by the FDA prior to being marketed in the United States. Manufacturers of biologics may also be subject to state regulation. Failure to comply with
regulatory requirements, both before and after product approval, may subject us and/or our partners, contract manufacturers and suppliers to administrative or judicial sanctions, including FDA delay or
refusal to approve applications, warning letters, product recalls, product seizures, import restrictions, total or partial suspension of production or distribution, fines and/or criminal prosecution.
The steps required before a biologic drug may be approved for marketing for an indication in the United States generally include:
1.
2.
3.
4.
5.
6.
preclinical laboratory tests and animal tests;
submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may commence;
adequate and well-controlled human clinical trials to establish the safety and efficacy of the product;
submission to the FDA of a BLA or supplemental BLA;
FDA pre-approval inspection of product manufacturers; and
FDA review and approval of the BLA or supplemental BLA.
Preclinical studies include laboratory evaluation, as well as animal studies to assess the potential safety and efficacy of the product candidate. Preclinical safety tests must be conducted in
compliance with FDA regulations regarding good laboratory practices. The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of
an IND which must become effective before human clinical trials may be commenced. The IND will automatically become effective 30 days after receipt by the FDA, unless the FDA before that time
raises concerns about the drug candidate or the conduct of the trials as outlined in the IND. The IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can proceed. There
can be no assurance that submission of an IND will result in FDA authorization to commence clinical trials or that, once commenced, other concerns will not arise that could lead to a delay or a hold on
the clinical trials.
Clinical trials involve the administration of the investigational product to healthy volunteers or to patients, under the supervision of qualified principal investigators. Each clinical study at each
clinical site must be reviewed and approved by an independent institutional review board, prior to the recruitment of subjects.
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Clinical trials are typically conducted in three sequential phases, but the phases may overlap and different trials may be initiated with the same drug candidate within the same phase of
development in similar or differing patient populations.
·
·
·
Phase I studies may be conducted in a limited number of patients, but are usually conducted in healthy volunteer subjects. The drug is usually tested for safety and, as appropriate, for
absorption, metabolism, distribution, excretion, pharmacodynamics and pharmacokinetics.
Phase II usually involves studies in a larger, but still limited, patient population to evaluate preliminarily the efficacy of the drug candidate for specific, targeted indications; to determine
dosage tolerance and optimal dosage; and to identify possible short-term adverse effects and safety risks.
Phase III trials are undertaken to further evaluate clinical efficacy of a specific endpoint and to test further for safety within an expanded patient population at geographically dispersed
clinical study sites.
Phase I, Phase II or Phase III testing may not be completed successfully within any specific time period, if at all, with respect to any of our product candidates. Results from one trial are not
necessarily predictive of results from later trials, the FDA may require additional testing or a larger pool of subjects beyond what we proposed as the clinical development process proceeds, thereby
requiring more time and resources to complete the trials. Furthermore, the FDA may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being
exposed to an unacceptable health risk, or may not allow the importation of the clinical trial materials if there is non-compliance with applicable laws.
The results of the preclinical studies and clinical trials, together with other detailed information, including information on the manufacture and composition of the product, are submitted to the
FDA as part of a BLA requesting approval to market the product candidate for a proposed indication. Under the Prescription Drug User Fee Act, as amended, the fees payable to the FDA for reviewing a
BLA, as well as annual fees for commercial manufacturing establishments and for approved products, can be substantial. The BLA review fee alone can exceed $2,400,000, subject to certain limited
deferrals, waivers and reductions that may be available. Each BLA submitted to the FDA for approval is typically reviewed for administrative completeness and reviewability within 45 to 60 days
following submission of the application. If found complete, the FDA will “file” the BLA, thus triggering a full review of the application. The FDA may refuse to file any BLA that it deems incomplete or
not properly reviewable at the time of submission. The FDA’s established goals are to review and act on 90% of priority BLA applications and priority original efficacy supplements within six months of
the 60-day filing date and receipt date, respectively. The FDA’s goals are to review and act on 90% of standard BLA applications and standard original efficacy supplements within 10 months of the 60-
day filing date and receipt date, respectively. The FDA, however, may not be able to approve a drug within these established goals, and its review goals are subject to change from time to time. Further,
the outcome of the review, even if generally favorable, may not be an actual approval but an “action letter” that describes additional work that must be done before the application can be approved. Before
approving a BLA, the FDA may inspect the facilities at which the product is manufactured or facilities that are significantly involved in the product development and distribution process, and will not
approve the product unless cGMP compliance is satisfactory. The FDA may deny approval of a BLA if applicable statutory or regulatory criteria are not satisfied, or may require additional testing or
information, which can delay the approval process. FDA approval of any application may include many delays or never be granted. If a product is approved, the approval will impose limitations on the
indicated uses for which the product may be marketed, will require that warning statements be included in the product labeling, may impose additional warnings to be specifically highlighted in the
labeling (e.g., a Black Box Warning), which can significantly affect promotion and sales of the product, may require that additional studies be conducted following approval as a condition of the approval,
may impose restrictions and conditions on product distribution, prescribing or dispensing in the form of a risk management plan, or otherwise limit the scope of any approval. To market a product for
other uses, or to make certain manufacturing or other changes requires prior FDA review and approval of a BLA Supplement or new BLA. Further post-marketing testing and surveillance to monitor the
safety or efficacy of a product is required. Also, product approvals may be withdrawn if compliance with regulatory standards is not maintained or if safety or manufacturing problems occur following
initial marketing. In addition, new government requirements may be established that could delay or prevent regulatory approval of our product candidates under development.
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As part of the Patient Protection and Affordable Care Act (the “healthcare reform law”), Public Law No. 111-148, under the subtitle of Biologics Price Competition and Innovation Act of 2009
(“BPCIA”), a statutory pathway has been created for licensure, or approval, of biological products that are biosimilar to, and possibly interchangeable with, earlier biological products approved by the
FDA for sale in the United States. Also under the BPCIA, innovator manufacturers of original reference biological products are granted 12 years of exclusive use before biosimilars can be approved for
marketing in the United States. There have been proposals to shorten this period from 12 years to seven years. The objectives of the BPCI are conceptually similar to those of the Drug Price Competition
and Patent Term Restoration Act of 1984, commonly referred to as the “Hatch-Waxman Act,” which established abbreviated pathways for the approval of drug products. A biosimilar is defined in the
statute as a biological product that is highly similar to an already approved biological product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically
meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency. Under this approval pathway, biological products can be approved based on
demonstrating they are biosimilar to, or interchangeable with, a biological product that is already approved by the FDA, which is called a reference product. If we obtain approval of a BLA, the approval
of a biologic product biosimilar to one of our products could have a significant impact on our business. The biosimilar product may be significantly less costly to bring to market and may be priced
significantly lower than our products.
Both before and after the FDA approves a product, the manufacturer and the holder or holders of the BLA for the product are subject to comprehensive regulatory oversight. For example, quality
control and manufacturing procedures must conform, on an ongoing basis, to cGMP requirements, and the FDA periodically inspects manufacturing facilities to assess compliance with cGMP.
Accordingly, manufacturers must continue to spend time, money and effort to maintain cGMP compliance. In addition, a BLA holder must comply with post-marketing requirements, such as reporting of
certain adverse events. Such reports can present liability exposure, as well as increase regulatory scrutiny that could lead to additional inspections, labeling restrictions, or other corrective action to
minimize further patient risk.
Special Development and Review Programs
Orphan Drug Designation
The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than
200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making the drug for this type of disease or condition will be recovered from sales in the
United States. In the United States, orphan drug designation must be requested before submitting a BLA or supplemental BLA.
In the European Union, the Committee for Orphan Medicinal Products grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention or
treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the European Union community. Additionally, this designation is granted for products
intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug in the
European Union would be sufficient to justify the necessary investment in developing the drug or biological product.
We received an orphan drug designation in the United States and Europe for multiple indications. Inhaled AAT for AATD has received an orphan drug designation in the United States and
Europe. The inhaled formulation of AAT for the treatment of cystic fibrosis has received an orphan drug designation in the United States and Europe. The inhaled formulation of AAT for the treatment of
bronchiectasis has received an orphan drug designation in the United States. The additional indication for Glassia for the treatment of newly diagnosed cases of Type-1 Diabetes has received an orphan
drug designation in the United States. In addition, the indication for AAT for the treatment of Graft versus Host Disease has received an orphan drug designation in the United States and Europe, and the
indication for AAT for the treatment of Prophylactic Graft versus Host Disease has received an orphan drug designation in the United States.
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In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. In
addition, if a product and its active ingredients receive the first FDA approval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the
FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the
product with orphan exclusivity. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. In addition, the FDA may rescind
orphan drug designation and, even with designation, may decide not to grant orphan drug exclusivity even if a marketing application is approved. Furthermore, the FDA may approve a competitor
product intended for a non-orphan indication, and physicians may prescribe the drug product for off-label uses, which can undermine exclusivity and hurt orphan drug sales.
In the European Union, orphan drug designation also entitles a party to financial incentives such as reduction of fees or fee waivers and 10 years of market exclusivity is granted following drug or
biological product approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to
justify maintenance of market exclusivity or a safer, more effective or otherwise clinically superior product is available.
In the European Union, an application for marketing authorization can be submitted after the application for orphan drug designation has been submitted, while the designation is still pending,
but should be submitted prior to the designation application in order to obtain a fee reduction. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review
and approval process.
Post-Approval Requirements
Any drug products for which we receive FDA approvals are subject to continuing regulation by the FDA. Certain requirements include, among other things, record-keeping requirements,
reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information on an annual basis or more frequently for specific events, product sampling and
distribution requirements, complying with certain electronic records and signature requirements and complying with FDA promotion and advertising requirements. These promotion and advertising
requirements include, among others, standards for direct-to-consumer advertising, prohibitions against promoting drugs for uses or in patient populations that are not described in the drug’s approved
labeling (known as “off-label use”), and other promotional activities. Failure to comply with FDA requirements can have negative consequences, including the immediate discontinuation of noncomplying
materials, adverse publicity, warning letters from or other enforcement by the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties. Such enforcement
may also lead to scrutiny and enforcement by other government and regulatory bodies. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not encourage,
market or promote such off-label uses.
The manufacturing of our product candidates is required to comply with applicable FDA manufacturing requirements contained in the FDA’s cGMP regulations. Our product candidates are either
manufactured at our production plant in Beit Kama, Israel, or, for products where we have entered into a strategic partnership with a third party to cooperate on the development of a product candidate, at
a third-party manufacturing facility. These regulations require, among other things, quality control and quality assurance, as well as the corresponding maintenance of comprehensive records and
documentation. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are also required to register their establishments and list any products they make with
the FDA and to comply with related requirements in certain states. These entities are further subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP
and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a
product after approval may result in serious and extensive restrictions on a product, manufacturer or holder of an approved BLA, as well as lead to potential market disruptions. These restrictions may
include suspension of a product until the FDA is assured that quality standards can be met, continuing oversight of manufacturing by the FDA under a “consent decree,” which frequently includes the
imposition of costs and continuing inspections over a period of many years, as well as possible withdrawal of the product from the market. In addition, changes to the manufacturing process generally
require prior FDA approval before being implemented. Other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA
review and approval, including possible user fees.
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The FDA also may require a Boxed Warning (e.g., a specific warning in the label to address a specific risk, sometimes referred to as a “Black Box Warning”), which has marketing restrictions,
and post-marketing testing, or Phase IV testing, as well as a Risk Evaluation and Minimization Strategy (REMS) plans and surveillance to monitor the effects of an approved product or place conditions
on an approval that could otherwise restrict the distribution or use of the product.
Other U.S. Healthcare Laws and Compliance Requirements
In the United States, our activities are potentially subject to regulation and enforcement by various federal, state and local authorities in addition to the FDA, including the Centers for Medicare
and Medicaid Services (formerly the Health Care Financing Administration), other divisions of the United States Department of Health and Human Services (e.g., the Office of Inspector General), the
U.S. Department of Justice and individual United States Attorney's offices within the Department of Justice, state attorneys general and state and local governments. To the extent applicable, we must
comply with the fraud and abuse provisions of the Social Security Act, the federal False Claims Act, the privacy and security provisions of the Health Insurance Portability and Accountability Act, and
similar state laws, each as amended. Pricing and rebate programs must comply with the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990 and the Veterans Health Care Act
of 1992, each as amended, as well as the “Anti-Kickback Law” provisions of the Social Security Act. If products are made available to authorized users of the Federal Supply Schedule of the General
Services Administration, additional laws and requirements apply. Under the Veterans Health Care Act (“VHCA”), drug companies are required to offer certain pharmaceutical products at a reduced price
to a number of federal agencies, including the United States Department of Veterans Affairs and United States Department of Defense, the Public Health Service and certain private Public Health Service-
designated entities in order to participate in other federal funding programs including Medicare and Medicaid. Legislative changes have purported to require that discounted prices be offered for certain
United States Department of Defense purchases for its TRICARE program via a rebate system. Participation under the VHCA requires submission of pricing data and calculation of discounts and rebates
pursuant to complex statutory formulas, as well as the entry into government procurement contracts governed by the Federal Acquisition Regulations. Furthermore, the FCPA prohibits any U.S. individual
or business from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or
decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA presents particular challenges in the pharmaceutical industry, because, in many
countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other
work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions. The failure to comply with laws governing international business practices may result
in substantial penalties, including civil and criminal penalties.
In order to distribute products commercially, we must comply with state laws and regulations that require the registration of manufacturers and wholesale distributors of pharmaceutical products
in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. Some states also
impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new
technology capable of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical companies to establish marketing
compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register their sales representatives, as well
as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical companies for use in sales and marketing, and to prohibit certain other sales and
marketing practices. Additionally, the federal “Sunshine” law and implementing regulations promulgated pursuant to Section 6002 of the healthcare reform law requires the tracking and reporting of
certain transfers of value made to U.S. physicians and/or certain teaching hospitals as well as ownership by a physician or a physician’s family member in a pharmaceutical manufacturer. Finally, all of
our activities are potentially subject to federal and state consumer protection and unfair competition laws. These laws may affect our sales, marketing, and other promotional activities by imposing
administrative and compliance burdens on us. In addition, given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject to the penalty provisions of
the pertinent state, and federal authorities.
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Europe/Rest of World Government Regulation
In addition to regulations in the United States, we are subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales and
distribution of our products.
Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials
or marketing of the product in those countries. For example, in the European Union, a clinical trial application (“CTA”) must be submitted to each member state’s national health authority and an
independent ethics committee. The CTA must be approved by both the national health authority and the independent ethics committee prior to the commencement of a clinical trial in the member state.
The approval process varies from country to country and the time may be longer or shorter than that required for FDA approval. In addition, the requirements governing the conduct of clinical trials,
product licensing, pricing and reimbursement vary greatly from country to country. In all cases, clinical trials are conducted in accordance with GCP and the applicable regulatory requirements and the
ethical principles that have their origin in the Declaration of Helsinki.
To obtain marketing approval of a drug under European Union regulatory systems, we may submit marketing authorization applications either under a centralized, decentralized or national
procedure. The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union member states. The centralized procedure is compulsory for medicines
produced by certain biotechnological processes, products designated as orphan medicinal products, and products with a new active substance indicated for the treatment of certain diseases, and optional
for those products that are highly innovative or for which a centralized process is in the interest of patients. For our products and product candidates that have received or will receive orphan designation
in the European Union, they will qualify for this centralized procedure, under which each product’s marketing authorization application will be submitted to the EMA. Under the centralized procedure in
the European Union, the maximum time frame for the evaluation of a marketing authorization application is 210 days (excluding clock stops, when additional written or oral information is to be provided
by the applicant in response to questions asked by the Scientific Advice Working Party of the Committee of Medicinal Products for Human Use (“CHMP”)). Accelerated evaluation might be granted by
the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest, defined by three cumulative criteria: the seriousness of the disease, such as heavy disabling or
life-threatening diseases, to be treated; the absence or insufficiency of an appropriate alternative therapeutic approach; and anticipation of high therapeutic benefit. In this circumstance, the EMA ensures
that the opinion of the CHMP is given within 150 days.
The decentralized procedure provides possibility for approval by one or more other, or concerned, member states of an assessment of an application performed by one member state, known as the
reference member state. Under this procedure, an applicant submits an application, or dossier, and related materials, including a draft summary of product characteristics, and draft labeling and package
leaflet, to the reference member state and concerned member states. The reference member state prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid
application. Within 90 days of receiving the reference member state’s assessment report, each concerned member state must decide whether to approve the assessment report and related materials. If a
member state cannot approve the assessment report and related materials on the grounds of potential serious risk to public health, the disputed points may eventually be referred to the European
Commission, whose decision is binding on all member states.
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For other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing
and reimbursement vary from country to country. In all cases, again, the clinical trials are conducted in accordance with GCPs and the applicable regulatory requirements and the ethical principles that
have their origin in the Declaration of Helsinki.
If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of
products, operating restrictions and criminal prosecution.
Pharmaceutical Coverage, Pricing and Reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of product candidates for which we obtain regulatory approval. In the United States and markets in other countries, sales
of any products for which we receive regulatory approval for commercial sale will depend, in part, on the coverage and reimbursement decisions made by payors. In the United States, third-party payors
include government health administrative authorities, managed care providers, private health insurers and other organizations. The process for determining whether a payor will provide coverage for a
drug product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the drug product. Payors may limit coverage to specific drug products on an approved
list, or formulary, which might not include all of the FDA-approved drug products for a particular indication. Third-party payors are increasingly challenging the price and examining the medical necessity
and cost-effectiveness of medical products and services, in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical
necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. A
payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Adequate third-party reimbursement may not be available to enable us to
maintain price levels sufficient to realize an appropriate return on our investment in product development.
Several significant laws have been enacted in the United States which affect the pharmaceutical industry. For example, as a result of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (“MMA”), a Medicare prescription drug benefit (Medicare Part D) became effective at the beginning of 2006. Medicare is the federal health insurance program for people who
are 65 or older, certain younger people with disabilities, and people with End-Stage Renal Disease. Medicare coverage and reimbursement for some of the costs of prescription drugs may increase
demand for any products for which we receive FDA approval. However, we would be required to sell products to Medicare beneficiaries through entities called “prescription drug plans,” which will
likely seek to negotiate discounted prices for our products.
Federal, state and local governments in the United States continue to consider legislation to limit the growth of healthcare costs, including the cost of prescription drugs. Future legislation and
regulation could further limit payments for pharmaceuticals such as the product candidates that we are developing. In addition, court decisions have the potential to affect coverage and reimbursement for
prescription drugs. It is unclear whether future legislation, regulations or court decisions will affect the demand for our product candidates once commercialized.
As another example, in March 2010, President Obama signed into law the Patient Protection and Affordable Care Act and the Healthcare and Education Reconciliation Act of 2010 (collectively
referred to as the “health care reform law”). The health care reform law made significant changes to the United States healthcare system, such as imposing new requirements on health insurers, expanding
the number of individuals covered by health insurance, modifying healthcare reimbursement and delivery systems, and establishing new requirements designed to prevent fraud and abuse. In addition,
provisions in the health care reform law promote the development of new payment and healthcare delivery systems, such as the Medicare Shared Savings Program, bundled payment initiatives and the
Medicare pay for performance initiatives.
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The health care reform law and the related regulations, guidance and court decisions have had, and will continue to have, a significant impact on the pharmaceutical industry. In addition to the
general reforms briefly described above, provisions of the health care reform law directly address drugs. For example, the health care reform law:
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increases the minimum level of Medicaid rebates payable by manufacturers of brand-name drugs from 15.1% to 23.1%;
requires Medicaid rebates for covered outpatient drugs to be extended to Medicaid managed care organizations;
requires manufacturers of drugs covered under Medicare Part D to participate in a coverage gap discount program, under which they must agree to offer 50% point-of-sale discounts off
negotiated prices of applicable brand drugs to eligible Medicare beneficiaries during their coverage gap period; and
imposes a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” to specified federal government programs.
On April 1, 2016, final regulations issued by the Centers for Medicare and Medicaid Services to implement the changes to the Medicaid Drug Rebate Program under the healthcare reform law
became effective.
Some provisions of the healthcare reform law have yet to be fully implemented, and President Donald Trump has vowed to repeal the healthcare reform law. On January 20, 2017, President
Donald Trump signed an executive order stating that the administration intended to seek prompt repeal of the healthcare reform law, and, pending repeal, directed by the U.S. Department of Health and
Human Services and other executive departments and agencies to take all steps necessary to limit any fiscal or regulatory burdens of the healthcare reform law. On October 12, 2017, President Trump
signed another Executive Order directing certain federal agencies to propose regulations or guidelines to permit small businesses to form association health plans, expand the availability of short-term,
limited duration insurance, and expand the use of health reimbursement arrangements, which may circumvent some of the requirements for health insurance mandated by the healthcare reform law. The
U.S. Congress has also made several attempts to repeal or modify the healthcare reform law. It is uncertain whether new legislation will be enacted to replace the healthcare reform law and whether any
such legislation would affect coverage and reimbursement for prescription drugs or otherwise include provisions intended to limit the growth of healthcare costs.
Different pricing and reimbursement schemes exist in other countries. In the European Community, governments influence the price of pharmaceutical products through their pricing and
reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which
products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that
compare the cost-effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control
company profits. The downward pressure of healthcare costs in general, particularly prescription drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of
new products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.
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The marketability of any drug candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and
reimbursement. In addition, emphasis on managed care in the United States has increased and we expect will continue to increase the pressure on pharmaceutical pricing. Coverage policies and third-party
reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage
policies and reimbursement rates may be implemented in the future.
Intellectual Property
Our success depends, at least in part, on our ability to protect our proprietary technology and intellectual property, and to operate without infringing or violating the proprietary rights of others.
We rely on a combination of patent, trademark, trade secret and copyright laws, know-how, intellectual property licenses and other contractual rights (including confidentiality and invention assignment
agreements) to protect our intellectual property rights.
Patents
As of December 31, 2017, we owned for use within our field of business five families of patents or patent applications, which are registered or applied for in the United States and also in the
European Union, Russia, Turkey, Israel, certain Latin American countries, Canada, Australia and other countries, four PCT patent applications and five US provisional applications. At present, one patent
protecting our manufacturing process is considered to be material to the operation of our business as a whole. Such patent has been issued in a variety of jurisdictions, including Australia, Austria,
Belgium, Canada, Denmark, Estonia, Israel, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Slovenia, Poland, Spain, Portugal, Sweden, Switzerland, Turkey, the United Kingdom and the
United States, and expires in 2024.
Our patents generally relate to the separation and purification of proteins and their respective pharmaceutical compositions and are expected to expire at various dates between 2018 and 2027.
Our patent applications relate to the use of our products and their delivery methods. We also rely on trade secrets to protect certain aspects of our separation and purification technology.
The patent positions of companies like ours are generally uncertain and involve complex legal and factual questions. Our ability to maintain and solidify our proprietary position for our
technology will depend on our success in obtaining effective claims and enforcing those claims once granted. We do not know whether any of our patent applications or any patent applications that we
license will result in the issuance of any patents and there is no guarantee that patent applications that were filed with the patent offices, which are still pending, will be eventually granted and will be
registered. Additionally, our issued patents and those that may be issued in the future may be challenged, opposed, narrowed, circumvented or found to be invalid or unenforceable, which could limit our
ability to stop competitors from marketing related products or the length of term of patent protection that we may have for our products. We cannot be certain that we were the first to invent the inventions
claimed in our owned patents or patent applications and/or the first to file said patent applications. In addition, our competitors or other third parties may independently develop similar technologies that
don’t fall within the scope of the technology protected under our patents, or duplicate any technology developed by us, and the rights granted under any issued patents may not provide us with any
meaningful competitive advantages against these competitors. Furthermore, because of the extensive time required for research and development, testing and regulatory review of a potential product until
authorization for marketing, it is possible that, before any of our products can be commercialized, any related patent may expire or remain in force for only a short period following commercialization,
thereby reducing any advantage of the patent.
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Trademarks
We rely on trade names, trademarks and service marks to protect our name brands. Our registered trademarks in several countries, such as United States and the European Union, Israel, and
certain Latin American countries, include the trademarks GLASSIA, RESPIKAM, KAMRAB, KEDRAB, KAMADA RESPIRA, KamRHO VENTIA, KAMADA and Rebinolin.
Trade Secrets and Confidential Information
We rely on, among other things, confidentiality and invention assignment agreements to protect our proprietary know-how and other intellectual property that may not be patentable, or that we
believe is best protected by means that do not require public disclosure. For example, we require our employees, consultants and service providers to execute confidentiality agreements in connection with
their engagement with us. Under such agreement, they are required, during the term of the commercial relationship with us and thereafter, to disclose and assign to us inventions conceived in connection
with their services to us. However, there can be no assurance that these agreements will be fulfilled or shall be enforceable, or that these agreements will provide us with adequate protection. See “Item 3.
Key Information — D. Risk Factors — In addition to patented technology, we rely on our unpatented proprietary technology, trade secrets, processes and know-how.”
We may be unable to obtain, maintain and protect the intellectual property rights necessary to conduct our business, and may be subject to claims that we infringe or otherwise violate the
intellectual property rights of others, which could materially harm our business. For a more comprehensive summary of the risks related to our intellectual property, see “Item 3. Key Information — D.
Risk Factors.”
Property
Our production plant was built on land that Kamada Assets (2001) Ltd. (“Kamada Assets”), our 74%-owned subsidiary, leases from the Israel Land Administration pursuant to a capitalized long-
term lease. Kamada Assets subleases the property to us. The property covers an area of approximately 16,880 square meters. The initial sublease expires in 2058 and we have an option to extend the
sublease for an additional term of 49 years. The production plant includes our manufacturing facility, manufacturing support systems, packaging, warehousing and logistics areas, laboratory facilities and
an area for the manufacture of snake bite anti-serum, as well as office buildings.
Since January 2017, we have leased approximately 2,200 square meters of a building located in the Kiryat Weizmann Science Park in Rehovot, Israel, which replaced our former Ness Ziona
premises. This property houses our head office, our research and development laboratory and additional departments such as our research and development, clinical, medical, regulatory and business
development departments.
Environmental
We believe that our operations comply in material respects with applicable laws and regulations concerning the environment. While it is impossible to predict accurately the future costs
associated with environmental compliance and potential remediation activities, compliance with environmental laws is not expected to require significant capital expenditures and has not had, and is not
expected to have, a material adverse effect on our earnings or competitive position.
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Organizational Structure
Our significant subsidiaries are set forth below. All subsidiaries are either 100 percent owned by us or controlled by us. All companies are incorporated and registered in the country in which they
operate as listed below:
Legal Name
Kamada Biopharma Limited
Kamada Inc.
Bio-Kam Ltd.
Kamada Assets Ltd.
Legal Proceedings
Jurisdiction
England and Wales
Delaware
Israel
Israel
We are subject to various claims and legal actions during the ordinary course of our business. We believe that there are currently no claims or legal actions that would have a material adverse
effect on our financial position, operations or potential performance.
Item 4A. Unresolved Staff Comments
Not applicable.
Item 5. Operating and Financial Review and Prospects
The following discussion of our financial condition and results of operations should be read in conjunction with “Item 3. Key Information—Selected Financial Data” and our consolidated
financial statements and the related notes to those statements included elsewhere in this Annual Report. In addition to historical consolidated financial information, the following discussion and analysis
contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results and timing of selected events may differ materially from those anticipated in these forward-
looking statements as a result of many factors, including those discussed under “Item 3. Key Information—D. Risk Factors” and elsewhere in this Annual Report.
The audited consolidated financial statements for the years ended December 31, 2017, 2016 and 2015 in this Annual Report have been prepared in accordance with IFRS as issued by the IASB.
None of the financial information in this Annual Report has been prepared in accordance with U.S. GAAP.
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Overview
We are a plasma-derived protein therapeutics company with an existing marketed product portfolio and a late-stage product pipeline. We develop and produce specialty plasma-derived protein
therapeutics and currently market these products through strategic partners in the United States and directly, through local distributors, in several emerging markets. We use our proprietary platform
technology and know-how for the extraction and purification of proteins from human plasma to produce AAT in a high purity, liquid form, as well as other plasma-derived proteins. AAT is a protein
derived from human plasma with known and newly discovered therapeutic roles given its immuno-modulatory, anti-inflammatory, tissue protective and antimicrobial properties. Our flagship product,
Glassia, is the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA (Glassia is also approved for self-administration). We market Glassia through a strategic
partnership with Shire in the United States. In addition to Glassia, we have a product line consisting of eight other products which are marketed in more than 15 countries including Israel, Russia, Brazil,
India and other countries in Latin America and Asia. In August 2017, we received FDA approval for anti-rabies immunoglobulin as a post-exposure prophylaxis against rabies infection. We expect to
launch KamRAB in the United States, under the trademark "KEDRAB," in 2018. In addition to our propriety products we leverage our expertise and presence in the plasma-derived protein therapeutics
market by distributing more than 10 complementary products in Israel that are manufactured by third parties.
Our lead product in development is Inhaled AAT for AATD, for which we completed a pivotal Phase II/III clinical trial in Europe and filed the MAA with the EMA in the first quarter of 2016.
Following our discussions with the EMA in regards to the study results, in July 2017, we withdrew the MAA in Europe for our Inhaled AAT. Following extensive discussions with the EMA, we
concluded that the EMA did not view the data submitted as sufficient, in terms of safety and efficacy, for approval of the MAA, and that the supplementary data needed for approval required an additional
clinical trial. See “Item 4. Information on the Company—Our Product Pipeline and Development Program—Inhaled Formulations of AAT—AATD.” We have also completed a Phase II clinical trial with
our Inhaled AAT for AATD in the United States. We are currently in discussions with the FDA with respect to a new pivotal Phase III study for Inhaled AAT designed to address both FDA and EMA
concerns regarding the safety and efficacy. Upon conclusion of these discussions and subject to an approved IND we intend to initiate the new pivotal Phase III clinical trial in the United States, and
resubmit the MAA after such clinical trial is successfully completed, with the data to be collected in such clinical trial. However, it is not certain when we will initiate such Phase III clinical trial, as the
FDA expressed concerns and questions regarding safety and efficacy, and we are currently in discussions with the FDA regarding the IND approval. See “Risk Factors— Risk Related to Development,
Regulatory Approval and Commercialization of New Products Candidates Including Inhaled AAT.”
Our Segments
We operate in two segments: the Proprietary Products segment, in which we develop and manufacture plasma-derived therapeutics and market them in more than 15 countries, and the
Distribution segment, in which we distribute imported drugs in Israel, which are manufactured by third-parties, most of which are produced from plasma or its derivative products.
Segment performance is evaluated based on revenues and gross profit (loss). Items that are not allocated to our segments consist mainly of research and development costs, sales and marketing
expenses, general and administrative costs and financial expenses, net, each of which are managed on a group basis. For the year ended December 31, 2017, we derived $79.5 million of revenues from our
Proprietary Products segment, or 77% of total revenues, and $23.3 million of revenues from our Distribution segment, or 23% of total revenues. For the year ended December 31, 2016, we derived $56.0
million of revenues from our Proprietary Products segment, or 72% of total revenues, and $ 21.5 million of revenues from our Distribution segment, or 28% of total revenues. For the year ended
December 31, 2015, we derived $42.9 million of revenues from our Proprietary Products segment, or 61% of total revenues, and $27.0 million of revenues from our Distribution segment, or 39% of total
revenues.
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Factors Affecting Our Results of Operations
Demand for our Products
Over the past few years, we have seen an increase in demand for products in our Proprietary Products segment. In particular, in 2015, 2016 and 2017, our Glassia supplies to Shire increased by
more than 33% each year, and based on our agreement with Shire we expect Glassia supplies to continue and increase through 2020. We expect that our revenues will grow in a range of approximately
13% to 17% in 2018, allowing us to achieve our revenue goal of $116 to $120 million by 2018 through increased sales of our existing products in the Proprietary Products segment, mainly driven from
sales of Glassia and the launch of KEDRAB in the United States. as an anti-rabies prophylaxis treatment. As discussed below, after 2020, Shire has no obligation to purchase a minimum amount of
Glassia, and we expect that the resulting decrease in revenues will be partially offset by income from royalty payments from Shire on sales of Glassia and continued increased sales of Glassia in rest of the
world countries through local distributors and KEDRAB product in the United States.
The AAT augmentation market for AATD in the U.S., which is the primary market for Glassia, has grown by more than 8% annually in the last few years, and we expect that the overall market
for Glassia will continue to increase due to new patient identification. In the United States and Europe, we believe that AATD is currently significantly under-identified and under-treated, as we estimate
that only approximately 6% and 2.5% of all potential cases of AATD are treated in the United States and Europe, respectively, with an aggregate of up to an estimated 180,000-190,000 patients suffering
from AATD, of which less than 10% have been diagnosed. We expect that our market opportunity for our AAT products, including Glassia and Inhaled AAT for AATD (if approved), will continue to grow
as awareness of AATD expands due to factors such as marketing activities, inexpensive and effective diagnosis tools, and improved training. In addition, various awareness and patient identification
programs initiated by companies producing AATD treatments are expected to increase demand for Glassia and, once approved, Inhaled AAT for AATD.
Sales of our Distribution segment products are made through public tenders of Israeli hospitals and health maintenance organizations on an annual basis. The prices we can offer, as well as the
availability of products, are key factors in meeting the local demand of the Israeli market. Our Distribution segment experienced growth in sales in 2017 compared to 2016 despite the growing
competition. The Distribution segment may continue to grow if we will be able to increase our product portfolio or win more tenders.
Strategic Partnerships
In July 2010, we received FDA approval for the marketing of Glassia in the United States. Following this approval, we entered into a 30 year strategic arrangement with Shire (formerly Baxter
and Baxalta) for the marketing and distribution of Glassia in the United States, Canada, Australia and New Zealand and for the licensing of our technology, granting Shire rights to manufacture Glassia for
sales in these territories. We began recognizing revenues from sales of Glassia in the United States under this strategic arrangement with Shire in September 2010. From the inception of the strategic
arrangement through December 31, 2017, we have received $39.5 million from Shire for distribution rights, a portion of which has been accrued as deferred revenue, and for achieving milestones set forth
in the distribution and licensing agreements. We have recognized cumulative revenues until December 31, 2017 from Shire in the amount of $248 million. We currently generate revenues from sales of
Glassia to Shire, and incur cost of revenues to produce it. In accordance with the latest amendment to the manufacturing and distribution agreement, which became effective as of October 5, 2016, Shire
may begin producing Glassia in its own manufacturing facility as early as 2021, and pay us royalties. As Shire transitions to producing Glassia in its own facilities, we will incur a substantial reduction in
revenues (as well as costs of goods sold), driven by the reduction in Glassia manufacturing. Such decrease in revenues is expected to be partially offset by income from royalty payments from Shire on
sales of Glassia in the United States and continued increased sales of Glassia in the rest of the world countries through local distributors and by income from sales of KEDRAB in the United States. See
“Item 3. Key Information — D. Risk Factors — In our Proprietary Products segment, we currently rely on one of our strategic partners that accounts for a significant portion of our total sales and our
distribution plan for our principal product candidate relies on another strategic partner, and any disruption to our relationships with these distributors would have an adverse effect on our results of
operations and profitability.”
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In addition, in July 2011, we signed a strategic agreement with Kedrion to cooperate in the clinical development and exclusive marketing and sales in the United States of KEDRAB, our hyper-
immune anti-rabies prophlaxis treatment, which is expected to be launched in the United States in the first quarter of 2018. Kedrion markets its products in Europe, the United States and in approximately
40 other countries worldwide.
Product Development Costs
Since our company was founded, we have focused on developing a broad portfolio of plasma-derived protein therapeutics for a variety of indications. The development of plasma-derived protein
therapeutics is characterized by significant up-front product development costs, including, for example, costs for conducting pre-clinical and clinical trials to obtain regulatory approvals, regulatory
expenses, costs for materials for development, external consulting and services fees and opportunity costs for reallocating our production facility to produce clinical trial materials and conforming our
production processes for regulatory purposes. In order to reduce costs related to the development and regulatory approval of new protein therapeutics, in some cases we seek to share development costs
with strategic partners, such as Shire for the clinical trials for Glassia in the United States and Kedrion for the clinical trials for KEDRAB in the United States. See “Item 4. Information on the Company
— Strategic Partnerships — Shire (Glassia)” and “Business — Strategic Partnerships — Kedrion (KEDRAB).”
Product development costs may fluctuate from period to period, as our product candidates pass through various stages of development. For example, for the years ended December 31, 2017, 2016
and 2015, we incurred significant research and development expenses related to clinical trials related to Inhaled AAT for AATD in Europe and the United States and AAT for the treatment of newly
diagnosed Type-1 diabetes and lung transplantation rejection. We expect to continue to incur research and development expenses related to clinical trials, as well as other ongoing, planned or future
clinical trials with regards to our product pipeline. See “Item 4. Information on the Company — Our Product Pipeline and Development Program.”
Product Competition
The worldwide market for pharmaceuticals in general and biopharmaceutical and plasma products in particular has undergone a process of mergers and acquisitions among companies active in
such markets. This trend has led to a reduction in the number of competitors in the market, and the strengthening of the remaining competitors, mainly for specific immunoglobulin products.
While there are additional producers of AAT products approved in the United States and Europe, including Shire, we have not seen significant changes in these producers’ activities in the market.
Additionally, our strategic alliance with Shire has strengthened our competitive positioning in the market and we believe this will contribute to increased revenues in the future. However, this assumes the
continuation of our strategic partnership with Shire. See “Item 3. Key Information — D. Risk Factors — In our Proprietary Products segment, we currently rely on one of our strategic partners that
accounts for a significant portion of our total sales and our distribution plan for our principal product candidate relies on another strategic partner, and any disruption to our relationships with these
distributors would have an adverse effect on our results of operations and profitability.”
Costs of Raw Materials
In our Proprietary Products segment, a significant portion of our manufacturing costs are for raw materials consisting of plasma or fraction IV of plasma. The consolidation among plasma
companies has led to a decrease in the number of plasma suppliers in the world, as either manufacturers of plasma-based pharmaceuticals purchase plasma suppliers or plasma suppliers are shut down in
response to the number of manufacturers of plasma-based pharmaceuticals decreasing. In addition, in recent years, we have seen an increase in the development efforts for new plasma-derived products.
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Historically, we have not been subject to significant pricing fluctuations for plasma or fraction IV due to the consolidation of plasma suppliers or increased development efforts. Additionally, in
order to attempt to prevent future price fluctuations and ensure the availability of plasma and fraction IV, we have secured supply of plasma and fraction IV from multiple suppliers at fixed prices (subject
to adjustments for inflation or product concentration) for predetermined quantities.
In our Distribution segment, our costs are for the purchase of products for sale from our distributors. Our annual purchases are forecasted each year with each distributor, but individual product
purchases during the year are made on a purchase order basis. For these instances, we do not have minimum purchase obligations, and as such, are able to respond accordingly to pricing fluctuations that
occur year to year. Historically, we have not seen significant price fluctuations from our two largest suppliers. Unless absent of material changes in the market, such as a significant increase in the price of
plasma or plasma-derivatives shall occur, we do not expect a significant increase in the cost of purchasing products.
Key Components of Our Results of Operations
Revenues
In our Proprietary Products segment, we generate revenues from the sale of products to strategic partners and from the licensing of our technology. Historically, we have derived most of our
revenues from the sale of products and to a lesser extent from payments by the Israeli government related to our snake bite antiserum product. We derived a significant portion of our total revenues from
sales of Glassia to Shire. Sales to Shire accounted for approximately 59%, 52% and 37% of our total revenues in the years ended December 31, 2017, 2016 and 2015, respectively. Revenue from all sales
of Glassia comprised approximately 64%, 56% and 43% of our total revenues for the years ended December 31, 2017, 2016 and 2015, respectively. We expect revenues attributable to the sale of Glassia
to Shire will grow in the next three years, in line with the expected Glassia orders by Shire pursuant to the fifth amendment to the Manufacturing, Supply and Distribution Agreement, until Shire begins
production of Glassia, at which time our sales to Shire will be reduced and be replaced by royalties from Shire.
In our Distribution segment, we generate revenues from the sale in Israel of imported products produced by third parties. In the past three years, sales of IVIG have decreased due to growing
competition. Sales of IVIG accounted for approximately 12%, 17% and 24% of our total revenues for the years ended December 31, 2017, 2016 and 2015, respectively.
In the future, as we further commercialize our products, we expect to derive a greater percentage of our revenues from our Proprietary Products segment, mainly as a result of continued growth in
sales of our existing products, the expected launch of KEDRAB in the United States in 2018 and the potential launch, if approved, of new AAT products currently in different development phases.
Cost of Revenues and Gross Profit
Cost of revenues in our Proprietary Products segment includes expenses for the manufacturing of products such as raw materials, payroll, utilities, laboratory costs and depreciation. Cost of
revenues also includes provisions for write-downs of inventories and inventory write offs. Costs of revenues in our Distribution segment consists of costs of products acquired, packaging and labeling for
sales by us in Israel.
In addition to the successful strategic partnership with Shire and successful penetration to the U.S. market, we have focused during the years ended December 31, 2017, 2016 and 2015 on
increasing our production outputs and improving profitability. In addition, implementing significant technology improvements and streamlining our manufacturing process resulted in significantly
increased manufacturing capacity at our facility. The strategic partnership with Shire enabled us to achieve economies of scale and lower our per-unit costs, and we believe that the increase in production
capacity will lead to a further increase in profitability. We have been implementing production improvements for Glassia that we expect will lead to improved margins and higher productivity in
anticipation of increased demand for our existing products as well as for additional applications for AAT. Any changes in our Glassia production processes must be approved by the FDA.
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Gross profit is the difference between total revenues and the cost of revenues. Gross profit is mainly affected by volume of sales and launching new products, cost of raw materials and plant
maintenance and overhead. We have seen an increase in gross profitability in recent years as a result of the increase in our sales and the corresponding reduction in per unit costs attributable to greater
production output.
Our gross margins are generally higher in our Proprietary Products segment (35%, 33% and 28% for the years ended December 31, 2017, 2016 and 2015, respectively) than in our Distribution
segment (17%, 15%, 12% for the years ended December 31, 2017, 2016, and 2015, respectively). We expect that our overall gross margins will increase to the extent that our sales from Proprietary
Products segment increase as a percentage of our total sales, and we expect our gross margins in the Proprietary Products segment to increase further to the extent that our sales of Glassia (or other AAT
products) and KEDRAB increase as these products have higher gross margins than our immunoglobulin proprietary products sold in Rest of the World (“ROW”) countries.
Research and Development Expenses
Research and development expenses are incurred for the development of new products and processes and include conducting clinical trials, development materials, payroll, including scientists
and professionals for product registration and approval, external advisors and the allotted cost of our manufacturing facility for research and development purposes. While research and development
expenses are unallocated on a segment basis, the activities generally relate to our existing or in development proprietary products.
We expect our research and development expenses to increase in 2018 to reflect our plan to fund certain additional clinical trials for AAT for certain additional indications including Inhaled AAT
for AATD . However, actual spending could differ as our plans change and we invest in other drugs or potentially reduce our anticipated funding on research for existing products or partner with other
parties to fund development.
Selling and Marketing Expenses
Selling and marketing expenses principally consist of expenditures incurred for sales incentive, advertising, marketing or promotional activities, shipping and handling costs, product liability
insurance and business development activities, as well as marketing authorization fees to regulatory agencies. Due to our strategic partnerships in our Proprietary Products segment, we expect these costs
to remain at a similar level other than ongoing effort to increase sales of existing products. However, we may incur higher expenses in the future, as we have not entered into strategic partnerships for all
of our pipeline products, which we may decide to sell using our own direct sales force. We market our products in our Distribution segment to health maintenance organizations and hospitals in Israel and
recently also began to market products directly to patients.
General and Administrative Expenses
General and administrative expenses consist of compensation for employees in executive and administrative functions (including payroll, bonus, equity compensation and other benefits), office
expenses, professional consulting services, legal and audit fees as well as employee welfare costs. We expect general and administrative expenses to remain stable.
Financial Income
Financial income is comprised of interest income on amounts invested, in bank deposits and short-term investments and changes in fair value of financial instruments at fair value through profit
or loss.
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Income (expense) in respect of currency exchange differences and derivatives instruments
Income (expense) in respect of currency exchange differences and derivatives instruments are comprised of changes on balances in currencies other than our functional currency. Changes in the
fair value of derivatives instruments not designated as hedging instruments are reported to profit or loss.
Financial Expenses
Financial expenses are comprised of bank charges changes in the time value of provisions, changes in the fair value of financial assets or liabilities at fair value through profit and interest and
amortization of bank loans and capital leases.
Taxes on Income
We have not been required to pay income taxes since 1997 other than tax withheld in a foreign jurisdiction in 2012 and 2016 and payment made during 2016 of $1.3 million to the Israel Tax
Authority as a settlement agreement for the tax years 2004-2006.
One of our Israeli facilities has Approved Enterprise status granted by the Investment Center under the Investment Law, which made us eligible for a grant and certain tax benefits under that law
for a certain investment program. The investment program provided us with a grant in the amount of 24% of our approved investments, in addition to certain tax benefits, which will apply to the turnover
resulting from the operation of such investment program, for a period of up to ten consecutive years from the first year in which we generated taxable income. The tax benefits under the Approved
Enterprise status expired at the end of 2017. Additionally, we have obtained a tax ruling from the Israeli Tax Authority according to which, among other things, our activity has been qualified as an
“industrial activity,” as defined in the Investment Law, and is also eligible for tax benefits as a Privileged Enterprise, which will apply to the turnover attributed to such enterprise, for a period of up to ten
years from the first year in which we generated taxable income. The tax benefits under the Privileged Enterprise status are scheduled to expire at the end of 2020 and 2023. As of the date of this Annual
Report, we have not utilized any tax benefits under the Investment Law, other than the receipt of grants attributable to our Approved Enterprise status.
We may be subject to withholding taxes for payments we receive from foreign countries. If certain conditions are met, these taxes may be credited against future tax liabilities under tax treaties
and Israeli tax laws. However, due to our net operating loss carryforwards, it is uncertain whether we will be able to receive such credit and therefore, we may incur tax expenses.
We anticipate that as we further expand our sales into other countries, we could become subject to taxation based on such country’s statutory rates and our effective tax rate could fluctuate
accordingly.
As of December 31, 2017, we have net operating loss carryforwards of approximately $90.1 million. The net operating loss carryforwards have no expiration date. Following the full utilization of
our net operating loss carryforwards, we expect that our effective income tax rate in Israel will reflect the benefits discussed above.
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Results of Operations
The following table sets forth certain statement of operations data:
Revenues from Proprietary Products segment
Revenues from Distribution segment
Total revenues
Cost of revenues from Proprietary Products segment
Cost of revenues from Distribution segment
Total cost of revenues
Gross profit
Research and development expenses
Selling and marketing expenses
General and administrative expenses
Operating income (loss)
Financial income
Income (expense) in respect of currency exchange differences and derivatives instruments
Financial expense
Income (loss) before taxes on income
Taxes on income
Net income (loss)
Year Ended December 31, 2017 Compared to Year Ended December 31, 2016
Segment Results
Revenues:
Proprietary Products
Distribution
Total
Cost of Revenues:
Proprietary Products
Distribution
Total
Gross Profit:
Proprietary Products
Distribution
Total
$
2017
Year Ended December 31,
2016
(in thousands, except per share data)
2015
$
79,559
23,266
102,825
51,335
19,402
70,737
32,088
11,973
4,398
8,273
7,444
500
(612)
(162)
7,170
269
6,901
$
$
55,958
21,536
77,494
37,723
18,411
56,134
21,360
16,245
3,243
7,353
(5,481)
469
127
(126)
(5,011)
1,722
(6,733) $
42,952
26,954
69,906
30,901
23,640
54,541
15,365
16,530
3,652
6,607
(11,424)
463
625
(934)
(11,270)
-
(11,270)
Change
2017 vs. 2016
2017
2016
Amount
Percent
79,559
23,266
102,825
$
$
51,335
19,402
70,737
$
$
28,224
3,864
32,088
$
$
55,958
21,536
77,494
$
$
37,723
18,411
56,134
$
$
18,235
3,125
21,360
$
$
23,601
1,730
25,331
13,612
991
14,603
9,989
739
10,728
42.2%
8%
32.7%
36%
5.4%
26%
54.8%
23.7%
50.2%
$
$
$
$
$
$
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Revenues
In the year ended December 31, 2017, we generated $102.8 million of total revenues, compared to$77.5 million in the year ended December 31, 2016, an increase of $25.3 million, or
approximately 33%. This increase was primarily due to a 23.6 million increase in our Proprietary Products segment revenues, mainly due to an increase in sales of Glassia in United States, and a $1.7
million increase in our Distribution segment, mainly attributable to increased sales of new products and a different mix of sales.
Cost of Revenues
In the year ended December 31, 2017, we incurred $70.7 million of cost of revenues, compared to $56.1 million in the year ended December 31, 2016, an increase of $14.6 million, or
approximately 26%.The cost of revenues in our Proprietary Products segment increased by $13.6 million mainly due to an increase in volume of sales. The cost of revenues in our Distribution segment
increased by $1 million, primarily due to an increase in volume of sales.
Gross profit in our Proprietary Products segment increased by $10 million in 2017, primarily due to an increase in sales of Glassia in United States. Gross profit in our Distribution segment
increased by $0.7 million in 2017, primarily due to different mix of sales with higher gross margin. As a percentage of total revenues, gross margin increased to 31.2% for the year ended December 31,
2017 from 27.6% for the year ended December 31, 2016. Gross margin for the Proprietary Products segment, as a percentage of revenues from that segment, was 35.5% and 32.6% for the years ended
December 31, 2017 and 2016, respectively. Gross margin for the Distribution segment, as a percentage of revenues from that segment, was 16.6% and 14.5% for the years ended December 31, 2017 and
2016. The increase in gross profit margin was primarily driven by an increase in the Proprietary Products segment revenues.
Research and Development Expenses
In the year ended December 31, 2017, we incurred $12 million of research and development expenses, compared to $16.2 million in the year ended December 31, 2016, a decrease of $4.2
million, or approximately 26%. This decrease was primarily due to a $4.5 million decrease in clinical trial expenses, mainly attributed to a decrease in expenses in connection with the Inhaled AAT ,Type-
1 Diabetes and Anti Rabies clinical trials as a result of their deferral to 2018, partially offset by an increase in labor costs. Research and development expenses accounted for approximately 11.6% and
21.0% of total revenues for the years ended December 31, 2017 and 2016, respectively.
Set forth below are the research and development expenses associated with our major development programs in the years ended December 31, 2017 and 2016:
Inhaled AAT
AAT for newly diagnosed Type-1 Diabetes
AAT IV for lung transplantation rejection and for GvHD
Anti Rabies
Unallocated salary
Unallocated facility cost allocated to research and development
Unallocated other expenses
Total research and development expenses
88
Year ended December 31,
2016
2017
(in thousands)
949
475
734
340
6,413
2,325
737
11,973
$
$
2,695
2,320
194
1,772
5,237
3,244
783
16,245
$
$
Research and development expenses for Inhaled AAT for AATD decreased by $1.7 million in 2017 due to the completion of the clinical trial in 2016 and the withdrawal of the EMA application
for Inhaled Alpha1-Antitrypsin in 2017. Research and development expenses for Type-1 Diabetes decreased by $1.8 in 2017 due to the completion of the clinical trial. Research and development expenses
for Anti Rabies decreased by $1.4 million in 2017 as we received FDA approval of KEDRAB in 2017 for Post-Exposure Prophylaxis Against Rabies Infection. Unallocated expenses are expenses that are
not managed by project and are allocated between various tasks that are not always related to a major project. In the years ended December 31, 2017 and 2016, we incurred $6.4 million and $5.2 million,
respectively, of unallocated salary expenses, $2.3 million and $3.2 million, respectively, of facility costs allocated to improvements in processes and $0.7 million and $0.8 million, respectively, of
unallocated other expenses.
Our current intentions as to the short-term development timeline for our major development programs are described in “Business — Our Product Pipeline and Development Program,” and we
also have long-term development goals. However, we cannot determine with full certainty the duration and completion costs of the current or future clinical trials of our major development programs or if,
when, or to what extent we will generate revenues from the commercialization and sale of any product candidates. We or our strategic partners may never succeed in achieving marketing approval for any
product candidates. The duration, costs and timing of clinical trials and our major development programs will depend on a variety of factors, including the uncertainties of future clinical and preclinical
studies, uncertainties in clinical trial enrollment rates and significant and changing government regulation and whether our current or future strategic partners are committed to and make progress in
programs licensed to them, if any. In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial
viability. See “Item 3. Key Information — D. Risk Factors — Risk Related to Development, Regulatory Approval and Commercialization of New Products Candidates Including Inhaled AAT.”
We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each
product candidate's commercial potential. We cannot forecast with any degree of certainty which of our product candidates, if any, will be subject to future collaborations or how such arrangements would
affect our development plans or capital requirements.
Selling and Marketing Expenses
In the year ended December 31, 2017, we incurred $4.4 million of selling and marketing expenses, compared to $3.2 million in the year ended December 31, 2016, an increase of $1.2 million, or
approximately 37.5%. This increase was primarily due to a $0.2 million increase in marketing support to distributors and a $0.4 million increase in regulatory fees. Selling and marketing expenses
accounted for approximately 4.3% and 4.2% of total revenues for the years ended December 31, 2017 and 2016, respectively.
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General and Administrative Expenses
In the year ended December 31, 2017, we incurred $8.3 million of general and administrative expenses, compared to $7.4 million in the year ended December 31, 2016, an increase of $0.9
million, or approximately 12.1%. This increase was primarily due to an increase of $0.7 million in labor costs and employee related expenses. General and administrative expenses accounted for
approximately 8.0% and 9.5% of total revenues for the years ended December 31, 2017 and 2016, respectively.
Financial Income
In each of the years ended December 31, 2017 and December 31, 2016 we generated $0.5 million of financial income from our short term investment portfolio.
Expense in respect of currency exchange differences and derivatives instruments
In the year ended December 31, 2017, we incurred $0.6 million of expenses in respect of currency exchange differences on balances in other currencies versus the U.S. dollar compared to income
of $0.1 million in the year ended December 31, 2016.
Financial Expenses
In the year ended December 31, 2017, we incurred $0.2 million of financial expenses, compared to $0.1 million in the year ended December 31, 2016.
Taxes on Income
In the year ended December 31, 2017, we had $0.3 million taxes on income mainly due to surplus expenses. In the year the ended December 31, 2016, we had $1.7 million taxes on income
mainly due to a settlement agreement with the Israeli Tax Authorities for the tax years 2004-2006, pursuant to which we paid $1.3 million.
Year Ended December 31, 2016 Compared to Year Ended December 31, 2015
Segment Results
Revenues:
Proprietary Products
Distribution
Total
Cost of Revenues:
Proprietary Products
Distribution
Total
Gross Profit:
Proprietary Products
Distribution
Total
Change
2016 vs. 2015
2016
2015
Amount
Percent
55,958
21,536
77,494
$
$
$
37,723
18,411
56,134
$
$
$
18,235
3,125
21,360
$
$
$
42,952
26,954
69,906
$
$
30,901
23,640
54,541
$
$
12,051
3,314
15,365
$
$
13,006
(5,418)
7,588
6,822
(5,229)
1,593
6,184
(189)
5,995
30.2%
(20.1)%
10.8%
22%
(22.1)%
2.9%
51.3%
(5.7)%
39.0%
$
$
$
$
$
$
$
$
$
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Revenues
In the year ended December 31, 2016, we generated $77.5 million of total revenues, compared to $69.9 million in the year ended December 31, 2015, an increase of $7.6 million, or
approximately 10.9%. This increase was primarily due to a $13.0 million increase in our Proprietary Products segment revenues mainly due to an increase in sales of Glassia in United States, partially
offset by a decrease of $5.4 million in our Distribution segment mainly attributable to decrease in sales of IVIG products due to increased competition for these products.
Cost of Revenues
In the year ended December 31, 2016, we incurred $56.1 million of cost of revenues, compared to $54.5 million in the year ended December 31, 2015, an increase of $1.6 million or
approximately 3%. The cost of revenues in our Proprietary Products segment increased by $6.8 million, which was primarily due to increase of a $3.5 million in cost of products sold mainly due to
increase in volume of sales and $ 2.6 million resulting from unexpected temporary shutdown of our manufacturing plant following a routine planned maintenance shutdown and inventory write-off
occurred in the fourth quarter. The cost of revenues in our Distribution segment decreased by $5.2 million, which was primarily due to a decrease in volume of sales.
Gross profit in our Proprietary Products segment increased by $6.2 million in 2016, primarily due to an increase in sales of Glassia in United States, partially offset the unexpected temporary
shutdown of our manufacturing plant and inventory write-off occurred in the fourth quarter of 2016. Gross profit in our Distribution segment remained stable. As a percentage of total revenues, gross
margin increased to 27.6% from 21.97% for the years ended December 31, 2016 and 2015. Gross margin for the Proprietary Products segment, as a percentage of revenues from that segment, was 32.6%
and 28% for the years ended December 31, 2016 and 2015, respectively. Gross margin for the Distribution segment, as a percentage of revenues from that segment, was 14.5% and 12.3% for the years
ended December 31, 2016 and 2015. The increase in gross profit margin was primarily driven by an increase in the Proprietary Products segment revenues.
Research and Development Expenses
In the year ended December 31, 2016, we incurred $16.2 million of research and development expenses, compared to $16.5 million in the year ended December 31, 2015, a slight decrease of
$0.3 million, or approximately 2%. This decrease was primarily due to a $1.5 million decrease in facility costs allocated to research and development partially offset by an increase of $0.5 million in labor
costs and a $0.3 million increase in clinical trial and external consultant costs mainly relating the submission of the MAA to EMA and the BLA to FDA. . Research and development expenses accounted
for approximately 21.0% and 23.6% of total revenues for the years ended December 31, 2016 and 2015, respectively.
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Set forth below are the research and development expenses associated with our major development programs in the years ended December 31, 2016 and 2015:
Year ended December 31,
2015
2016
Inhaled AAT
AAT for newly diagnosed Type-1 Diabetes
AAT IV for lung transplantation rejection and for GvHD
Anti Rabies
Unallocated salary
Unallocated facility cost allocated to research and development
Unallocated other expenses
Total research and development expenses
$
$
$
(in thousands)
2,695
2,320
194
1,772
5,237
3,244
783
16,245
$
4,939
1,753
-
-
4,566
4,569
703
16,530
Research and development expenses for Inhaled AAT for AATD decreased by $2.2 million due to the completion of the clinical trial and registration in the European Union that occurred in 2016
and the completion of phase II clinical trial in the U.S. Research and development expenses for Type-1 Diabetes increased by $0.6 million. In 2016, we had a $1.7 million expense due to BLA submission
for our KamRAB product for Prophylaxis treatment of rabies disease in the United States. Unallocated expenses are expenses that are not managed by project and are allocated between various tasks that
are not always related to a major project. In the years ended December 31, 2016 and 2015, we incurred $5.2 million and $4.6 million, respectively, of unallocated salary expenses, $3.2 million and $4.6
million, respectively, of facility costs allocated to improvements in processes and $0.8 million and $0.7 million, respectively, of unallocated other expenses.
Selling and Marketing Expenses
In the year ended December 31, 2016, we incurred $3.2 million of selling and marketing expenses, compared to $3.7 million in the year ended December 31, 2015, a decrease of $0.5 million, or
approximately 13%. This decrease was primarily due to a $0.3 million decrease in marketing support to distributors and $0.2 million decrease in marketing expenses. Selling and marketing expenses
accounted for approximately 4.2% and 5.2% of total revenues for the years ended December 31, 2016 and 2015, respectively.
General and Administrative Expenses
In the year ended December 31, 2016, we incurred $7.4 million of general and administrative expenses, compared to $6.6 million in the year ended December 31, 2015, an increase of $0.8
million, or approximately 10.8%. This increase was primarily due to an increase of $0.5 million in labor costs. General and administrative expenses accounted for approximately 9.9% and 10.1% of total
revenues for the years ended December 31, 2016 and 2015, respectively.
Financial Income
In the years ended December 31, 2016, and December 31, 2015 we generated $0.5 million of financial income from our short term investment portfolio.
92
Expense in respect of currency exchange differences and derivatives instruments
In the year ended December 31, 2016, we incurred income of $0.1 million in respect of currency exchange differences on balances in other currencies versus the U.S. dollar compared to income
of $0.6 million in the year ended December 31, 2015.
Financial Expenses
In the year ended December 31, 2016, we incurred $0.1 million of financial expenses, compared to $0.9 million in the year ended December 31, 2015, a decrease of $0.8 million, or
approximately 88% associated with a decrease in financial expenses for our convertible debt which was fully repaid at the end of 2015.
Taxes on Income
In the year ended December 31, 2016, we had $1.7 million taxes on income mainly due to a settlement agreement with the Israeli Tax Authorities for the tax years 2004-2006, pursuant to which
we paid $1.3 million. In the year ended December 31, 2015 we had no taxes on income.
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Quarterly Results of Operations
The following tables set forth unaudited quarterly consolidated statements of operations data for the four quarters of fiscal years 2017 and 2016. We have prepared the statement of operations
data for each of these quarters on the same basis as the audited consolidated financial statements included elsewhere in this Annual Report and, in the opinion of management, each statement of operations
includes all adjustments, consisting solely of normal recurring adjustments, necessary for the fair statement of the results of operations for these periods. This information should be read in conjunction
with the audited consolidated financial statements and related notes included elsewhere in this Annual Report. These quarterly operating results are not necessarily indicative of our operating results for
any future period.
December 31,
2017
September 30,
2017
June 30, 2017
March 31,
2017
December 31,
2016
September 30,
2016
June 30, 2016
March 31,
2016
Three Months Ended
Revenues from Proprietary Products
Revenues from Distribution
Total revenues
Cost of revenues from Proprietary
$
Products
Cost of revenues from
Distribution
Total cost of revenues
Gross profit
Research and development expenses
Selling and marketing expenses
General and administrative expenses
Operating income (loss)
Financial income
Income (expense) in respect of
currency exchange differences and
derivatives, net
$
28,991
6,719
35,710
18,608
5,472
24,080
11,630
1,917
1,265
2,003
6,445
234
$
17,058
5,860
22,918
11,509
4,961
16,470
6,448
3,418
1,021
2,323
(314)
92
(133)
-
Financial expense
Income (loss) before taxes on income
Taxes on income
Net income (loss)
$
(112)
6,434
182
6,252
$
(14)
(236)
-
(236) $
Liquidity and Capital Resources
$
$
(in thousands)
6,636
5,012
11,648
5,165
4,185
9,350
2,298
3,151
1,028
1,830
(3,711)
78
26,874
5,675
32,549
16,053
4,784
20,837
11,712
3,487
1,084
2,117
5,024
96
$
17,688
6,570
24,258
13,880
5,700
19,580
4,678
4,221
686
1,665
(1,894)
81
$
15,044
4,329
19,373
$
12,106
6,960
19,066
9,433
7,479
3,644
13,097
6,276
4,415
866
2,014
(1,019)
90
5,958
13,437
5,629
3,502
856
1,861
(590)
133
(245)
(13)
4,862
-
4,862
$
(234)
259
(73)
90
(23)
(3,890)
87
(3,977) $
(20)
(1,574)
234
(1,808) $
(39)
(1,041)
-
(1,041) $
(30)
(397)
1,188
(1,585) $
11,120
3,677
14,797
6,931
3,089
10,020
4,777
4,107
835
1,813
(1,978)
165
(149)
(37)
(1,999)
300
(2,299)
Our primary uses of cash are to fund working capital requirements, research and development expenses and capital expenditures. Historically, we have funded our operations primarily through
cash flow from operations (including sales of our approved proprietary products and sales of distributional products), payments received in connection with strategic partnerships (including milestone
payments from collaborating agreements), sales of ordinary shares (including our 2005 initial public offering on the Tel-Aviv Stock Exchange, our 2013 initial public offering on NASDAQ and our
ordinary share offering which closed in August 2017), and the issuance of convertible debentures and warrants to purchase our ordinary shares. The balance of cash and cash equivalents and short-term
investments as of December 31, 2017, 2016 and 2015 totaled $43.0 million, $28.6 million and $28.6 million, respectively. We plan to fund our future operations through continued sale and distribution of
our proprietary and distributed products, commercialization and or out-licensing of our pipeline product candidates, and raising additional capital through the sale of equity or debt.
94
We have certain strategic partnership and distribution agreements under which we receive payments for the achievement of certain milestones. Since inception and through December 31, 2017,
we received an aggregate of $48.5 million in payments under these agreements, and there are $5.5 million in payments under these agreements that we could potentially receive if we achieve additional
milestones as set forth in such agreements. See “Item 4. Information on the Company— Strategic Partnerships — Shire (Glassia).”
In August 2017, we consummated an underwritten public offering of an aggregate of 3,833,334 ordinary shares (including the exercise of the underwriters’ overallotment option), at a price of
$4.50 per share. We received net proceeds from the offering of approximately $15.6 million.
Our capital expenditures for the years ended December 31, 2017, 2016 and 2015 were $4.1 million, $2.6 million and $2.7 million, respectively. Our capital expenditures currently relate primarily
to the maintenance and improvements of our facilities. We expect our capital expenditures to remain substantially similar in the near term as such capital expenditures are planned to be attributable mainly
to the maintenance and improvements of our facilities.
We believe our current cash and cash equivalents and short-term investments will be sufficient to satisfy our liquidity requirements for the next 12 months.
One of Cash Flows from Operating Activities
Net cash provided by operating activities was $3.6 million for the year ended December 31, 2017. This net cash provided by operating activities reflects a net income of $6.9 million and non-cash
expenses of $4.6 million and an increase in trade receivables of $9.9 million that were collected at the beginning of 2018.
Net cash provided by operating activities was $1.9 million for the year ended December 31, 2016. This net cash provided by operating activities reflects a net loss of $6.7 million and non-cash
expenses of $5.7 million and a decrease in trade receivables of $3.5 million that were collected during 2016.
Net cash used in operating activities was $14.0 million for the year ended December 31, 2015. This net cash used in operating activities reflects a net loss of $11.3 million and non-cash expenses
of $5.1 million partially offset by an increase in trade receivables of $5.6 million that were collected immediately after the end of 2015 and a decrease in deferred revenues of $2.4 million reflecting
revenues that were collected in advance of 2015.
Cash Flows from Investing Activities
Net cash used in investing activities was $15.6 million for the year ended December 31, 2017. This net cash used in investing activities reflects $11.5 million net cash invested in short term
investments and investment in property, plant and equipment of $4.2 million.
Net cash provided by investing activities was $1.6 million for the year ended December 31, 2016. This net cash provided by investing activities reflects $4.2 million net cash proceeds from sale
of short term investments, partially offset by investment in property, plant and equipment of $2.6 million.
Net cash provided by investing activities was $11.2 million for the year ended December 31, 2015. This net cash provided by investing activities reflects $13.9 million net cash proceeds from
sale of short term investments, partially offset by investment in property, plant and equipment of $2.7 million.
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Cash Flows from Financing Activities
Net cash provided by financing activities was $15.3 million for the year ended 2017. This net cash provided by financing activities reflects $15.6 million net proceeds from the issuance of shares
offset by a $0.5 million repayment of long-term loans.
Net cash provided by financing activities was $1.5 million for the year ended 2016. This net cash provided by financing activities reflects a $1.5 million net receipt of long term loans. The
Company has pledged specific assets which are the subject of those loans.
Net cash used by financing activities was $6.3 million for the year ended December 31, 2015. This net cash used by financing activities reflects a $7.8 million repayment of convertible
debentures offset by $1.2 million proceeds from the exercise of share options and by $0.2 million receipt of long term loan.
Contractual Obligations and Commitments
The following is a summary of our contractual obligations and commitments as of December 31, 2017 (in thousands):
Purchase commitments
Long-term debt obligations (1)
Operating lease obligations
Total
Total
37,948
2,095
6,432
46,475
Less than 1 Year
-
669
1,033
1,702
$
$
$
1 – 3 Years
4-5 Years
6 Year and
thereafter
-
1,166
1,504
2,670
-
260
1,354
1,614
-
-
2,541
2,541
(1)
Includes interest payments on our long term loans which bear annually fixed interest rate in the range of 3.15%-3.55%.
Purchase commitments are obligations under purchase agreement or purchase orders that are non-cancelable. Operating leases consist of contractual obligations from offices and vehicles leases
agreements.
We are also obligated to make certain severance or pension payments to our Israeli employees upon their retirement under Israeli law. Due to the uncertainty of the timing of future cash flows
associated with these payments (see Note 2r and Note 16 in our consolidated financial statements included in this Annual Report), we are unable to make reasonably reliable estimates for the period of
cash settlement, if any, with respect to such obligations.
Seasonality
We have experienced in the past, and expect to continue to experience, certain fluctuations in our quarterly revenues. Historically, our revenues have been strongest in our fourth quarter and
weaker in the rest of the quarters.
Off-Balance Sheet Arrangements
As of December 31, 2017, we have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial
condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
96
Critical Accounting Policies and Estimates
This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with IFRS as issued by the IASB.
The preparation of these financial statements requires management to make estimates that affect the reported amounts of our assets, liabilities, revenues and expenses. Significant accounting policies
employed by us, including the use of estimates, are presented in the notes to the consolidated financial statements included elsewhere in this Annual Report. We periodically evaluate our estimates, which
are based on historical experience and on various other assumptions that management believes to be reasonable under the circumstances. Critical accounting policies are those that are most important to
the portrayal of our financial condition and results of operations and require management’s subjective or complex judgments, resulting in the need for management to make estimates about the effect of
matters that are inherently uncertain. If actual performance should differ from historical experience or if the underlying assumptions were to change, our financial condition and results of operations may
be materially impacted. In addition, some accounting policies require significant judgment to apply complex principles of accounting to certain transactions, such as acquisitions, in determining the most
appropriate accounting treatment.
While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements appearing elsewhere in this Annual Report, we believe that the following
accounting policies are the most critical for fully understanding and evaluating our financial condition and results of operations.
Revenue Recognition
Revenues are recognized in profit or loss when the revenues can be measured reliably, it is probable that the economic benefits associated with the transaction will flow to us and the costs
incurred or to be incurred in respect of the transaction can be measured reliably. Revenues are measured at the fair value of the consideration received less any trade discounts, volume rebates and returns.
Revenues from the sale of goods are recognized when all the significant risks and rewards of ownership of the goods have passed to the buyer and the seller no longer retains continuing
managerial involvement. The delivery date is usually the date on which ownership passes.
We estimate provisions for returns in arrangements allowing the customers to return expired inventory, or inventory that is close to its end of shelf life, based on historical experience of product
returns and specific return exposure.
Milestone revenues are recognized when we meet the milestones.
Contracts that are multiple element arrangements
We entered into strategic alliance agreements under which we grant to our strategic alliance partner an exclusive license to intellectual property rights for the development and commercialization
of our proprietary products. The agreements contain multiple elements, including license fees, payments based on achievement of specified milestones, funding for research and development services and
royalties on sales of our products.
Based on the type of element, revenues from these agreements are allocated to the various accounting units and recognized for each accounting unit separately. An element constitutes a separate
accounting unit if and only if it has a separate value to the customer. Significant judgment is required to allocate elements to each accounting unit. Depending upon how such judgment is exercised, the
timing and amount of revenue recognized could differ significantly. Revenue in the various accounting units containing elements is recognized when the criteria for revenue recognition regarding the
elements of that accounting unit have been met according to their type and only to the extent of the consideration that is not contingent upon completion or performance of the remaining elements in the
contract.
97
Recognizing revenue on a gross or net basis
We recognize revenues from the distribution of drugs in Israel manufactured by third-parties for clinical uses. If we were to operate or act as an agent or broker without being exposed to the risks
and rewards associated with the transaction, our revenues would be presented on a net basis. However, we operate as a principal supplier and not as an agent or broker, and therefore, are exposed to the
risks and rewards associated with the transaction. As such, our revenues are presented on a gross basis.
Clinical Trial Accruals and Related Expenses
We accrue and expense costs for clinical trial activities performed by third parties (or CROs), based upon estimates made as of the reporting date of the work completed over the life of the
individual study in accordance with agreements established with the CRO. We determine the estimates of clinical activities incurred at the end of each reporting period through discussion with internal
personnel and outside service providers as to the progress or stage of completion of trials or services, as of the end of each reporting period, pursuant to contracts with numerous clinical trial centers and
CROs and the agreed upon fee to be paid for such services.
To date, we have not experienced significant changes in our estimates of clinical trial accruals after a reporting period. However, due to the nature of estimates, we cannot assure you that we will
not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical trials.
Inventories
Inventories are measured at the lower of cost and net realizable value. The cost of inventories is comprised of costs of purchase and shipping and handling. Net realizable value is the estimated
selling price in the ordinary course of business less the estimated costs of completion and the estimated selling costs.
We periodically evaluate the condition and age of inventories and make provisions for slow-moving inventories accordingly. Unfavorable changes in market conditions may result in a need for
additional inventory reserves that could adversely impact our gross margins. Conversely, favorable changes in demand could result in higher gross margins when we sell products.
Inventory that is produced following a change in manufacturing process prior to final approval of regulatory authorities is subject to our estimates as to the probability of receipt of such approval.
We periodically reassess the probability of such approval and the remaining shelf life of such inventory. If regulatory approval is not granted, the cost of this inventory will be charged to research and
development expenses.
Impairment of Non-financial Assets
We evaluate the need to record an impairment of the carrying amount of non-financial assets whenever events or changes in circumstances indicate that the carrying amount is not recoverable. If
the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their recoverable amount. The recoverable amount is the higher of fair value less costs of sale and
value in use. In measuring value in use, the expected future cash flows are discounted using a pre-tax discount rate that reflects the risks specific to the asset. The recoverable amount of an asset that does
not generate independent cash flows is determined for the cash-generating unit to which the asset belongs. Impairment losses are recognized in profit or loss.
An impairment loss of an asset, other than goodwill, is reversed only if there have been changes in the estimates used to determine the asset’s recoverable amount since the last impairment loss
was recognized. Reversal of an impairment loss, as above, will not be increased above the lower of the carrying amount that would have been determined (net of depreciation or amortization) had no
impairment loss been recognized for the asset in prior years and its recoverable amount. The reversal of impairment loss of an asset presented at cost is recognized in profit or loss.
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We had no impairment of non-financial assets in 2017.
Share-based Payment Transactions
Our employees and other service providers are entitled to remuneration in the form of equity-settled share-based payment transactions (options and restricted shares).
The cost of equity-settled transactions with employees is measured at the fair value of the equity instruments granted at grant date. We use the binomial model when estimating the grant date fair
value of equity settled share options. We selected the binomial option pricing model as the most appropriate method for determining the estimated fair value of our share-based awards without market
conditions. For options granted to service providers, the fair value is remeasured as the services are received. We use the share price at the grant date when estimating the grant date fair value of equity
settled restricted shares.
The determination of the grant date fair value of options using an option pricing model is affected by estimates and assumptions regarding a number of complex and subjective variables. These
variables include the expected volatility of our share price over the expected term of the options, share option exercise and cancellation behaviors, expected exercise multiple, risk-free interest rates,
expected dividends and the price of our ordinary shares on the TASE, which are estimated as follows:
·
·
·
·
·
·
Expected Life. The expected life of the share options is based on historical data, and is not necessarily indicative of the exercise patterns of share options that may occur in the future.
Volatility. The expected volatility of the share prices reflects the assumption that the historical volatility of the share prices on the TASE is reasonably indicative of expected future
trends.
Risk-free interest rate. The risk-free interest rate is based on the yields of non-index-linked Bank of Israel treasury bonds with maturities similar to the expected term of the options for
each option group.
Expected forfeiture rate. The post-vesting forfeiture rate is based on the weighted average historical forfeiture rate.
Dividend yield and expected dividends. We have not recently declared or paid any cash dividends on our ordinary shares and do not intend to pay any cash dividends. We have therefore
assumed a dividend yield and expected dividends of zero.
Share price on the TASE. The price of our ordinary shares on the TASE used in determining the grant date fair value of options is based on the price on the grant date.
If any of the assumptions used in the binomial model change significantly, share-based compensation for future awards may differ materially compared with the awards granted previously.
The cost of equity-settled transactions is recognized in profit or loss, together with a corresponding increase in equity, during the period which the performance and/or service conditions are to be
satisfied, ending on the date on which the relevant employees become fully entitled to the award. The cumulative expense recognized for equity-settled transactions at the end of each reporting period
until the vesting date reflects the extent to which the vesting period has expired and our best estimate of the number of equity instruments that will ultimately vest. The expense or income recognized in
profit or loss represents the change between the cumulative expense recognized at the end of the reporting period and the cumulative expense recognized at the end of the previous reporting period.
99
No expense is recognized for awards that do not ultimately vest, except for awards where vesting is conditional upon a market condition, which are treated as vesting irrespective of whether the
market condition is satisfied, provided that all other vesting conditions (service and/or performance) are satisfied.
If we modify the conditions on which equity-instruments were granted, an additional expense is recognized for any modification that increases the total fair value of the share-based payment
arrangement or is otherwise beneficial to the employee/other service provider at the modification date.
If a grant of an equity instrument is cancelled, it is accounted for as if it had vested on the cancellation date, and any expense not yet recognized for the grant is recognized immediately. However,
if a new grant replaces the cancelled grant and is identified as a replacement grant on the grant date, the cancelled and new grants are accounted for as a modification of the original grant, as described
above.
Post-employment Benefits Liabilities
Our post-retirement benefit plans are normally financed by contributions to insurance companies and classified as defined contribution plans or as defined benefit plans.
We operate a defined benefit plan in respect of severance pay pursuant to the Severance Pay Law. See Note 2r and Note 16 in our consolidated financial statements included in this Annual Report
for more details.
The present value of our severance pay depends on a number of factors that are determined on an actuarial basis using a number of assumptions. The assumptions used in determining the net cost
or income for severance pay and plan assets include a discount rate. Any changes in these assumptions will impact the carrying amount of severance pay and plan assets.
Other key assumptions inherent to the valuation include employee turnover, inflation, expected long term returns on plan assets and future payroll increases. The expected return on plan assets is
determined by considering the expected returns available on assets underlying the current investments policy. These assumptions are given a weighted average and are based on independent actuarial
advice and are updated on an annual basis. Actual circumstances may vary from these assumptions, giving rise to a different severance pay liability.
Accounting for Income Taxes
At the end of each reporting period, we are required to estimate our income taxes. There are transactions and calculations for which the ultimate tax determination is uncertain during the ordinary
course of business, determined according to complex tax laws and regulations. Where the effect of these laws and regulations is unclear, we use estimates in determining the liability for the tax to be paid
on our past profits, which we recognize in our financial statements. We believe the estimates, assumptions and judgments are reasonable, but this can involve complex issues which may take a number of
years to resolve. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences will impact the income tax and deferred income tax provisions in
the period in which such determination is made.
100
Short-term investments
Our short term bank investments include deposits that have a maturity of more than three months from the deposit date but less than one year, financial assets held for trading at fair value through
profit or loss that include equity investments and debt securities and Available for Sale (“AFS”) financial investments that include debt securities. Debt securities in the category of AFS are those that are
intended to be held for an indefinite period of time and that may be sold in response to needs for liquidity or in response to changes in the market conditions. After initial measurement, AFS financial
investments are subsequently measured at fair value with unrealized gains and losses recognized in OCI and credits in the AFS reserve until the investment is derecognized, at which time the cumulative
gain or loss is recognized in other operating income, or the investment is determined to be impaired, at which time the cumulative loss is reclassified from AFS reserve to the statement of profit or loss as
a finance cost. Interest earned while holding AFS financial investments is reported as interest income using the EIR (Effective Interest Rate) method. For AFS financial investments, we assess at each
reporting date whether there is objective evidence that an investment is impaired. We have classified all marketable securities as short-term, even though the stated maturity date may be one year or more
beyond the current balance sheet date, because we may sell these securities prior to maturity to meet liquidity needs or as part of a risk versus reward assessment.
Item 6. Directors, Senior Management and Employees
Executive Officers and Directors
The following table sets forth certain information relating to our executive officers and directors as of March 1, 2018.
Name
Executive Officers:
Amir London
Chaime Orlev
Liliana Bar, PhD
Yael Brenner
Shani Dotan
Eran Nir
Orit Pinchuk
Dr. Michal Stein
Dr. Naveh Tov
Directors:
Leon Recanati*
David Tsur
Dr. Michael Berelowitz*
Avraham Berger*
Asaf Frumerman*
Jonathan Hahn
Dr. Abraham Havron*
Prof. Itzhak Krinsky, Ph.D*
Gwen A. Melincoff *
Shmuel (Milky) Rubinstein*
___________
*
Age Position
49 Chief Executive Officer
47 Chief Financial Officer
63 Vice President, Research and Development and IP
54 Vice President, Quality
45 Vice President, Human Resources
45 Vice President, Operations
53 Vice President, Regulatory Affairs and PVG
44 Vice President, Medical Director for Immunology
53 Vice President, Clinical Development and Medical Director for Pulmonary Diseases
69 Chairman
67 Director, Active Deputy Chairman
73 Director
66 Director, Chairman of Audit Committee
33 Director
35 Director
70 Director, Chairman of Compensation Committee
66 Director
65 Director
78 Director
Independent director under the Nasdaq listing requirements.
101
Executive Officers
Amir London has served as our Chief Executive Officer since July 2015. Prior to that, Mr. London served as our Senior Vice President, Business Development since December 2013. Mr. London
brings with him over 20 years of senior management and international business development experience. From 2011 to 2013, Mr. London served as the Chief Operating Officer of Fidelis Diagnostics, a
U.S.-based provider of innovative in-office medical diagnostic services. Earlier in his career, from 2009 to 2011, Mr. London was the Chief Executive Officer of Promedico, a leading Israeli-based $350
million healthcare distribution company, and the General Manager of Cure Medical, from 2006 to 2009, providing contract manufacturing services for clinical studies, as well as home-care solutions.
From 1995 to 2006, Mr. London was a Partner with Tefen, an international publicly-traded operations management consulting firm, responsible for the firm's global biopharma practice. Mr. London holds
a B.Sc. degree in Industrial and Management Engineering from the Technion – Israel Institute of Technology.
Chaime Orlev has served as our Chief Financial Officer since December 2017. Prior to that, Mr. Orlev had served in senior finance roles for nearly 20 years, with approximately 12 years spent in
the life sciences industry. Most recently, from September 2016 to November 2017, Mr. Orlev served as Chief Financial Officer and Vice President Finance and Administration at Bioblast Pharma Ltd.
(NASDAQ: ORPN), a clinical-stage, orphan disease-focused biotechnology company. Prior to that, from 2010, Mr. Orlev served as Vice President Finance and Administration at Chiasma (NASDAQ:
CHMA), a clinical-stage biopharmaceutical company focused on treating rare and serious chronic diseases. In this role, Mr. Orlev helped lead the company’s 2015 over $100 million initial public offering
and listing on NASDAQ, and participated in the negotiations and closing of the licensing agreement for the company’s lead product to F. Hoffmann-La Roche. Previously, Mr. Orlev was Chief Financial
Officer at Oramed Pharmaceuticals Inc. (NASDAQ: ORMP), which has developed an innovative technology to transform injectable treatments into oral therapies. In this role, he led multiple capital
raises. Mr. Orlev is a certified public accountant in Israel, holds an MBA degree from the Leon Recanati Graduate School of Business Administration at the Tel Aviv University and a BA degree in
Business Administration from the College of Management in Israel.
Dr. Liliana Bar has served as our Vice President, Research and Development and IP since June 2012. Prior to joining us, Dr. Bar was Director of the Development and Base Business Unit and
Manager of the Development and Base Unit of Omrix from 2007. Dr. Bar holds a M.Sc. degree and PhD in Applied Chemistry from the Hebrew University of Jerusalem and was a Research Associate at
the Biochemistry Department at Hadassah Medical School at the Hebrew University of Jerusalem and a Research Associate at the Biochemistry Department of University of Virginia.
Yael Brenner has served as our Vice President, Quality since March 2015. Ms. Brenner has more than 20 years of experience in Quality Management, including Quality Assurance and Quality
Control managerial positions in the pharmaceutical industry. Prior to joining Kamada, from 2007 to 2015, Ms. Brenner was at Teva Pharmaceuticals Industries, lastly as Senior Director Quality Operations
of Teva Kfar Sava Site, managing over 400 employees in Quality Assurance, Quality Control and Regulatory Affairs. Ms. Brenner holds B.Sc. and M.Sc. degrees in Chemistry from the Technion - Israel
Institute of Technology, and in addition is a Certified Quality Engineer (CQE) from the American and Israeli Societies for Quality.
Shani Dotan has served as our Vice President, Human Resources since November 2013. Ms. Dotan has more than a decade of expertise in local and global organizations and in all HR aspects.
Prior to joining us, Ms. Dotan served as the Human Resources Manager at Teva Pharmaceuticals at the Jerusalem plant from 2010 to 2013 and a Training Manager at Teva Pharmaceuticals at two plants
from 2007 to 2010. Ms. Dotan holds an MA degree and a BA degree in Psychology, both from Ben-Gurion University.
Eran Nir has served as our Vice President, Operations since November 1, 2016. Mr. Nir has over 14 years of operations management experience in the pharmaceutical and medical industries. Mr.
Nir’s recent roles include management of TEVA's Pharmaceutical plant in Jerusalem from 2002 to 2011, VP Operations of Amelia Cosmetics from 2014 to 2015 and management of a medical equipment
plant of Philips Medical Systems from 2015 to 2016. Mr. Nir’s extensive experience spans across the management of large scale FDA and EMA- approved manufacturing facilities, tech-transfer of new
products from development to production and the implementation of world-class operational excellence systems. Mr. Nir holds a B.Sc. degree in Industrial and Management Engineering and a MBA
degree in Business Management, both from Ben-Gurion University.
102
Orit Pinchuk has served as our Vice President, Regulatory Affairs and PVG since October 2014. Ms. Pinchuk has experience of more than 20 years in the pharmaceutical industry, fulfilling key
positions that cover, among others, disciplines of Regulatory Affairs and Compliance. Prior to joining Kamada, Ms. Pinchuk was at Teva Pharmaceuticals Industries, from 1993 to 2014, where she served
as Director of Compliance and Regulatory Affairs, Operation Israel and Senior Director Regulatory Affairs, Research and Development and Operation Israel. Ms. Pinchuk has extensive experience with
FDA, EMA and CANADA Health Authorities. Ms. Pinchuk holds a B.Tech degree in Textile Chemistry from Shenkar College for Engineering and Design and M.Sc. degree in Applied Chemistry from
the Hebrew University of Jerusalem.
Dr. Michal Stein has served as our Vice President, Medical Director for Immunology, since June 2017. Prior to that, from 2013 to 2017 Dr. Stein served as Medical Director at Sanofi-Aventis
Israel Ltd. In this position, Dr. Stein led the medical affairs and pharmacovigilance departments, overseeing all aspects of product life-cycle management and compliance with pharmacovigilance
regulations. From 2009 through 2013, Dr. Stein held multiple positions of increasing responsibility at Merck Sharp & Dohme, including Pharmacovigilance Country Lead, Medical & Scientific Liaisons
Team Leader and Medical Affairs Manager, with expertise in vaccines, women’s health and HIV. From 2005 through 2009, Dr. Stein served as Medical Affairs Manager, with expertise in oncology, at
Roche Pharmaceuticals. Prior to that, from 2001 through 2005, Dr. Stein was a practicing physician in Israel, first at Rabin Medical Center, Belinson Campus, and then at Schneider Children’s Medical
Center. Dr. Stein holds an MD degree from Sackler school of Medicine, Tel Aviv University.
Dr. Naveh Tov has served as our Vice President, Clinical Development and Medical Director for Pulmonary Diseases, since July 2016. Prior to joining us, Dr. Tov has served as our Medical
Director in a part- time consultancy role, from 2007. Dr. Tov served in both active hospital academic and clinical positions at Bnei Zion Medical Center, Haifa, Israel from 1994 through 2016. Dr. Tov
specializes in Internal, Pulmonary and Sleep Medicine and served as Head of the Pulmonary Unit and as Deputy of Internal Ward C at Bnei Zion Medical Center, for 14 years from 2002 through 2016.
During these years, Dr. Tov served in academia and held appointments at the Ruth and Bruce Rappaport Faculty of Medicine of The Technion – Israel Institute of Technology. Dr. Tov is a member of the
American Thoracic Society and the European Respiratory Society. Dr. Tov holds an M.D. and a Ph.D. from the Ruth and Bruce Rappaport Faculty of Medicine of The Technion – Israel Institute of
Technology.
Directors
Leon Recanati has served on our board of directors since May 2005 and has served as Chairman since March 2013. Mr. Recanati currently serves as a board member of Evogene Ltd., a plant
genomics company listed on the TASE and New York Stock Exchange. Mr. Recanati is also a board member of the following private companies: GlenRock Israel Ltd., GlenRock Medical, Gov, Govli
Limited, Microbes Inc., RelTech Holdings Ltd., Legov Ltd., Insight Capital Ltd., and Shavit Capital Funds. He is currently Chairman and Chief Executive Officer of GlenRock. Previously, Mr. Recanati
was Chief Executive Officer and/or Chairman of IDB Holding Corporation; Clal Industries Ltd.; Azorim Investment Development and Construction Co Ltd.; Delek Israel Fuel Corporation; and Super-Sol
Ltd. Mr. Recanati also founded Clal Biotechnologies Industries Ltd., a biotechnology investment company operating in Israel. Mr. Recanati holds an MBA degree from the Hebrew University of
Jerusalem and Honorary Doctorates from the Technion – Israel Institute of Technology and Tel Aviv University.
David Tsur has served as Active Deputy Chairman of our board of directors since July 2015. Prior to that, Mr. Tsur served as our Chief Executive Officer and a director since our inception. Prior
to co-founding Kamada in 1990, Mr. Tsur served as Chief Executive Officer of Arad Systems and RAD Chemicals Inc. Since January 2018, Mr. Tsur serves as a Chairman of the Board of Directors in
CollPlant Ltd., a company listed on the TASE and OTC stock Exchanges. Mr. Tsur has also held various positions in the Israeli Ministry of Economy and Industry (formerly named the Ministry of
Industry and Trade), including Chief Economist and Commercial Attaché in Argentina and Iran. Mr. Tsur holds a BA degree in Economics and International Relations and an MBA in Business
Management from the Hebrew University of Jerusalem.
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Dr. Michael Berelowitz has served on our board of directors since August 2015. Dr. Berelowitz brings over 40 years of clinical development and academic research experience, including 15
years of pharmaceutical development experience with Pfizer, Inc. From 2011 through 2015, Dr. Berelowitz served as a member of the board of directors of Endocrine Fellows Foundation. Dr. Berelowitz
currently serves as the chair of the corporate governance and nominations committee and as a member of the audit committee of Recro Pharma, Inc. Dr. Berelowitz also currently serves as a member of
the compensation committee of Oramed Pharmaceuticals Inc., where he has served on the board since May 2010. Since February 2017, Dr. Berelowitz has served as a member of the audit committee of
Cellect Biotechnology Ltd. While at Pfizer, Dr. Berelowitz was Senior Vice President and Head of Clinical Development and Medical Affairs in the Specialty Care Business Unit. Dr. Berelowitz held
various other roles at Pfizer, beginning as a Medical Director in the Diabetes Clinical Research team and then assuming positions of increasing responsibility. Prior to that, Dr. Berelowitz spent a number
of years in academia and has held appointments at the University of Chicago, University of Cincinnati College of Medicine, SUNY at StonyBrook and, most recently, Mount Sinai School of Medicine. Dr.
Berelowitz holds a MBChB degree from University Of Cape Town- School of Medicine.
Avraham Berger has served on our board of directors since August 2016. Mr. Berger was initially elected as an external director (within the meaning of the Israeli Companies Law, 1999 (the
“Companies Law”)) and served in such capacity until January 30, 2017, since which time he has served as an ordinary (non-external) director. Until 2014, Mr. Berger served as a senior partner and chief
executive officer of PwC Israel, for more than 20 years. Mr. Berger joined PwC Israel in 1976 and led it from 1991. Mr. Berger has vast experience in mergers and acquisitions and complex public
offerings, both in Israel and abroad. Mr. Berger lectures at professional forums and has published several articles in the professional press. Mr. Berger also serves as Chairman of the board of directors of
TopAudio Ltd. and serves as director on the board of Weizmann Institute of Science. Mr. Berger holds a Bachelor’s degree in Accounting and Economics awarded from Tel Aviv University and is a
certified public accountant in Israel.
Asaf Frumerman has served on our board of directors since December 2017. Mr. Frumerman is a partner at Brosh Capital Partners L.P. Prior to that, Mr. Frumerman served as an analyst at The
Dragon Variation Fund, and as an accountant at A. Frumerman & Co., from 2011 to 2013. From 2010 to 2011, Mr. Frumerman served as a counsel at Ernst & Young (Israel) Ltd. Mr. Frumerman holds a
BA degree in Accounting and LLB degree from the College of Management.
Jonathan Hahn has served on our board of directors since March 2010. Mr. Hahn serves as the President and a director of Tuteur where he has been since 2013. Prior to that, Mr. Hahn served as
Strategic Planning Manager at Tuteur and held a business development position in Forest Laboratories, Inc., based in New York. Mr. Hahn holds a BA degree from San Andrés University and an MBA
degree from New York University — Stern School of Business, with specializations in Finance and Entrepreneurship.
Dr. Abraham Havron has served on our board of directors since March 2011. Mr. Havron was initially elected as an external director (within the meaning of the Companies Law) and served in
such capacity until January 30, 2017, since which time he has served as an ordinary (non-external) director. From 2005 to 2014, Dr. Havron served as the Chief Executive Officer and a director of
PROLOR Biotech Ltd., which in 2013 merged with OPKO Health Inc. Dr. Havron is a 35-year veteran of the biotechnology industry and was a member of the founding team and Director of Research and
Development of Interpharm Laboratories Ltd. (a subsidiary of Merck Serono S.A.) from 1980 to 1987. Dr. Havron served as Vice-President Manufacturing and Process-Development of BioTechnology
General Ltd., based in Rehovot, Israel (now, a subsidiary of Ferring Pharmaceuticals) from 1987 to 1999; and Vice President and Chief Technology Officer of Clal Biotechnology Industries Ltd. from
1999 to 2003. Since 2014, Dr. Havron has also served on the board of directors of MediWound Ltd. (Nasdaq: MDWD) and Enlivex Theraputics Ltd., a private company. Dr. Havron earned his PhD in
Bio-Organic Chemistry from the Weizmann Institute of Science, and served as a Research Fellow at the Harvard Medical School, Department of Radiology.
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Prof. Itzhak Krinsky, Ph.D, has served on our board of directors since December 2017. Mr. Krinsky has broad-based expertise in the pharmaceutical industry, years of experience in investment
banking, and a distinguished academic career in finance and business economics. Prof. Krinsky developed extensive knowledge of the pharmaceutical industry during his 12 years of working at Teva
Pharmaceutical Industries Ltd., from which he retired in 2017. During his tenure at Teva, Prof. Krinsky served as Executive Vice President, Corporate Business Development, a member of the Teva
Executive Committee, Chairman of Teva Japan, Chairman of Teva South Korea, and Head of Business Development Asia Pacific. Prior to joining Teva, Prof. Krinsky held various senior positions at
investment banks in New York City, including with Bankers Trust, Deutsche Bank, and the Silverfern Group, Inc. Before his career on Wall Street, Prof. Krinsky was a Professor of Finance and Business
Economics at the Michael G. DeGroote School of Business, McMaster University, Ontario, Canada. Prof. Krinsky has published more than 80 articles in leading peer reviewed academic journals. Prof.
Krinsky currently serves as a director at following companies: Wavelength Pharmaceuticals, since October 2017, Halo Pharmaceutical, Inc., since June 2017, Concordia International Corp., since May
2017, Achellos Therapeutics, since April 2017 and Exodos Life Sciences Limited Partnership, since April 2017. In 2014, Prof. Krinsky was named by SCRIP as one of the top 100 Global Leaders in the
Pharmaceutical Industry. Prof. Krinsky received BA and MA degrees in Economics from Tel Aviv University and a Ph.D. in Economics from McMaster University in Canada.
Gwen A. Melincoff has served on our board of directors since February 2017. Ms. Melincoff has over 25 years of leadership experience in the biotechnology and pharmaceutical industries. Her
experience has spanned public and private company boards, venture financing, business development, licensing, mergers and acquisitions, research operations, marketing, product management and project
management. Ms. Melincoff is an advisor to Phase 1 Ventures and Verge Genomics. From August 2014 to September 2016, she served as Vice President of Business Development at BTG International
Inc. a UK specialist healthcare company. From August 2004 to January 2013, Ms. Melincoff was Senior Vice President of Business Development at Shire Pharmaceuticals. Additionally, from 2010 to
2013 she led the Strategic Investment Group (SIG). Ms. Melincoff served as a board member/board observer at Tobira Therapeutics (acquired by Allergan), DBV Technologies, AM Pharma, ArmaGen
Technologies, Promethera Biosciencs, Naurex Inc. (acquired by Allergan), Enterome. She is currently a member of the audit committee of PhotoCure ASA. Ms. Melincoff was named a “Top Women in
Biotech 2013” by Fierce Biotech as well as being named to the Powerlist 100 of Corporate Venture Capital in 2012 and 2013. Prior to joining Shire, Ms. Melincoff held managerial and business
development position at various pharmaceutical companies such as Adolor Corporation. Ms. Melincoff has a B.S in Biology, a Master’s of Science in Management, and has attained the designation of the
Certified Licensing Professional (CLP™).
Shmuel (Milky) Rubinstein has served on our board of directors since December 2017. Mr. Rubinstein has served as an external director of Clal Biotechnology Industries Ltd. since 2011. In
addition, Mr. Rubinstein currently serves on the board of the directors of several companies, including Exalenz Breathtaking Solutions Ltd., since 2008, Medison Biotech Ltd., since 2011, Trima Pharma
Ltd., since 2015, the National Authority for Yiddish Culture since 2014, and Ichilov Health Corporation since September 2017. Mr. Rubinstein serves as a member of the advisory board of Sol-Gel Ltd.,
since 2016. Mr. Rubinstein served as the Chairman of the board of directors of Tiltan Pharma Ltd. from 2015 to June 2017. Mr. Rubinstein served as the Chief Executive Officer and General Manager at
Taro Pharmaceuticals Industries Ltd. (NYSE:TARO) from 1990 to 2010. Mr. Rubinstein also acts as a consultant to several companies, including startup companies and for BDO. In 2003, Mr. Rubinstein
received the Industry Award from the Manufacturers Association of Israel. Mr. Rubinstein is a graduate of the International Marketing Course of the Wharton School of Business, Philadelphia, the United
States.
On November 9, 2017, we entered into a letter agreement with Brosh Capital Partners, L.P. and certain of its affiliates regarding, among other things, amending the agenda for our 2017 annual
general meeting of shareholders with respect to director nominees and board composition. Pursuant to the terms of the letter agreement, we agreed to amend the agenda for the 2017 annual general
meeting to, among other things: (i) fix the size of our Board of Directors at ten members; (ii) add Mr. Asaf Frumerman as a nominee for election to the Board of Directors by the shareholders at the
meeting; and (iii) add two industry experts to be specified in a revised agenda for the meeting. Accordingly, we filed an amended agenda for the 2017 annual general meeting, which included Mr. Asaf
Frumerman and two industry experts, Prof. Itzhak Krinsky and Mr. Shmuel (Milky) Rubinstein, as director nominees for election by the shareholders at the meeting. For additional information regarding
the foregoing letter agreement, see “Item 7. Major Shareholders and Related Party Transactions — Related Party Transactions — Brosh Letter Agreement.” For information regarding the holdings of the
Brosh Capital Partners group, see “Item 7. Major Shareholders and Related Party Transactions — Major Shareholders.”
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Under a shareholders' agreement entered into on March 6, 2013, the Recanati Group, on the one hand, and the Damar Group, on the other hand, have each agreed to vote the ordinary shares
beneficially owned by them in favor of the election of director nominees designated by the other group as follows: (i) three director nominees, so long as the other group beneficially owns at least 7.5% of
our outstanding share capital, (ii) two director nominees, so long as the other group beneficially owns at least 5.0% (but less than 7.5%) of our outstanding share capital, and (iii) one director nominee, so
long as the other group beneficially owns at least 2.5% (but less than 5.0%) of our outstanding share capital. In addition, to the extent that after the designation of the foregoing director nominees there are
additional director vacancies, each of the Recanati Group and Damar Group have agreed to vote the ordinary shares beneficially owned by them in favor of such additional director nominees designated
by the party who beneficially owns the larger voting rights in our company. See “Item 7. Major Shareholders and Related Party Transactions — Related Party Transactions — Shareholder Agreement.”
Board of Directors
Under our articles of association, the number of directors on our board of directors must be no less than five and no more than 11. Our current board of directors consists of ten directors, eight of
whom qualify as “independent directors” under the Nasdaq listing requirements, such that we comply with the NASDAQ Listing Rule that requires that a majority of our board of directors be comprised
of independent directors, within the meaning of NASDAQ Listing Rules.
Our directors are elected by the vote of a majority of the ordinary shares present, in person or by proxy, and voting at a shareholders’ meeting. Each director will hold office until the first annual
general meeting of shareholders following his or her appointment, unless the tenure of such director expires earlier pursuant to the Companies Law or unless he or she is removed from office as described
below.
Vacancies on our board of directors, including vacancies resulting from there being fewer than the maximum number of directors permitted by our articles of association, may generally be filled
by a vote of a simple majority of the directors then in office.
A general meeting of our shareholders may remove a director from office prior to the expiration of his or her term in office by a resolution adopted by holders of a majority of our shares voting
on the proposed removal, provided that the director being removed from office is given a reasonable opportunity to present his or her case before the general meeting.
Alternate Directors
As permitted under the Companies Law, our articles of association provide that any director may, subject to the board of directors’ approval, by written notice to us, appoint another person who is
qualified to serve as a director to serve as an alternate director. Under the Companies Law, a person who is not qualified to be appointed as a director, a person who is already serving as a director or a
person who is already serving as an alternate director may not be appointed as an alternate director. Nevertheless, a director may be appointed as an alternate director for a member of a committee of the
board of directors so long as he or she is not already serving as a member of such committee. Similarly, an independent director within the meaning of the Companies Law may not appoint an alternate
director unless such alternate director is eligible to be an independent director within the meaning of the Companies Law. An alternate director may be appointed for one meeting of the board of directors
or until notice is given of the cancellation of the appointment.
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External Directors
Under the Companies Law, companies incorporated under the laws of the State of Israel that are “public companies,” must appoint at least two external directors who meet the qualification
requirements in the Companies Law.
However, according to a recent amendment to regulations promulgated under the Companies Law, a company whose shares are traded on certain stock exchanges outside Israel (including the
Nasdaq Global Select Market, such as our company) that does not have a controlling shareholder and that complies with the requirements of the laws of the foreign jurisdiction where the company’s
shares are listed, as they apply to domestic issuers, with respect to the appointment of independent directors and the composition of the audit committee and compensation committee, may elect to exempt
itself from the requirements of Israeli law with respect to (i) the requirement to appoint outside directors and that one outside director serve on each committee of the board of directors authorized to
exercise any of the powers of the board of directors; (ii) certain limitations on the employment or service of an outside director or his or her spouse, children or other relatives, following the cessation of
the service as an outside director, by or for the company, its controlling shareholder or an entity controlled by the controlling shareholder; (iii) the composition, meetings and quorum of the audit
committee; and (iv) the composition and meetings of the compensation committee. If a company has elected to avail itself from the requirement to appoint external directors and at the time a director is
appointed all members of the board of directors are of the same gender, a director of the other gender must be appointed. According to the exemption, an external director serving at the time a company
elects to adopt the exemption may continue to serve as an “ordinary” (non-external) director until the earlier of (i) the end of his/her term and (ii) the second annual general meeting after the adoption of
the exemption (and thereafter may be re-elected for multiple terms), despite the two year “cooling off period during which former external directors are generally prohibited from serving in any capacity
for an Israeli company following external director service.
On January 30, 2017, following analysis of our qualification to rely on the exemption, our board of directors determined to adopt the exemption, following which our external directors serving at
such time, Dr. Abraham Havron and Avraham Berger, continued to serve as ordinary (non-external) directors. In accordance with the exemption, Avraham Berger will continue to serve term as an
ordinary (non-external) director until our 2018 annual general meeting, and may thereafter be re-elected as a director in accordance with the Companies Law. Dr. Havron’s term as an external director was
scheduled to expire in January 2017, and therefore, he was appointed by our board of directors to serve as an ordinary (non-external) director until our 2017 annual general meeting, at which meeting he
was re-elected to serve as a director, and he may thereafter be re-elected as a director in accordance with the Israeli Companies Law. If in the future we were to have a controlling shareholder, we would
again be required to comply with the requirements relating to external directors and the composition of the audit committee and compensation committee under Israeli law.
Audit Committee
We have an audit committee consisting of Mr. Avraham Berger, Dr. Abraham Havron and Mr. Shmuel (Milky) Rubinstein. Mr. Avraham Berger serves as the chairman of the audit committee.
According to the recent amendment to regulations promulgated under the Companies Law described above, an Israeli company whose shares are traded on certain stock exchanges outside Israel
(including the Nasdaq Global Select Market, such as our company) that does not have a controlling shareholder (within the meaning of the Companies Law), such as ourselves, and that complies with the
requirements of the laws of the foreign jurisdiction where the company’s shares are listed, as they apply to domestic issuers, with respect to the appointment of independent directors and the composition
of the audit committee and compensation committee, may elect to exempt itself from the requirements of Companies Law with respect to (among other things) the composition, quorum and majority
requirements at meetings of the audit committee. On January 30, 2017, following analysis of our qualification to rely on the exemption, our Board of Directors determined to adopt the exemption.
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Under the Exchange Act and Nasdaq listing requirements, we are required to maintain an audit committee consisting of at least three independent directors, each of whom is financially literate
and one of whom has accounting or related financial management expertise. Our board of directors has affirmatively determined that each member of our audit committee qualifies as an “independent
director” for purposes of serving on an audit committee under the Exchange Act and Nasdaq listing requirements. Our board of directors has determined that Avraham Berger qualifies as an “audit
committee financial expert,” as defined in Item 407(d)(5) of Regulation S-K. All members of our audit committee meet the requirements for financial literacy under the applicable rules and regulations of
the SEC and Nasdaq.
Audit Committee Role
Our audit committee generally provides assistance to our board of directors in fulfilling its legal and fiduciary obligations in matters involving our accounting, auditing, financial reporting and
internal control functions by reviewing the services of our independent accountants and reviewing their reports regarding our accounting practices and systems of internal control over financial reporting.
Our audit committee also oversees the audit efforts of our independent accountants. Our audit committee also acts as a corporate governance compliance committee and oversees the implementation and
amendment, from time to time, of our policies for compliance with Israeli and U.S. securities laws and applicable Nasdaq corporate governance requirements, including non-use of inside information,
reporting requirements, our engagement with related parties, whistleblower complaints and protection, and is also responsible for the handling of any incidents that may arise in violation of our policies or
applicable securities laws. Our board of directors has adopted an audit committee charter setting forth the specific responsibilities of the audit committee consistent with the Companies Law, and the rules
and regulations of the SEC and the Nasdaq listing requirements, which include:
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oversight of our independent auditors and recommending the engagement, compensation or termination of engagement of our independent auditors to the board of directors or
shareholders for their approval, as applicable, in accordance with the requirements of the Companies Law;
pre-approval of audit and non-audit services to be provided by the independent auditors;
reviewing and recommending to the board of directors approval of our quarterly and annual financial reports; and
overseeing the implementation and amendment of our policies for compliance with Israeli and U.S. securities laws and applicable Nasdaq corporate governance requirements.
Additionally, under the Companies Law, the role of the audit committee includes: (1) determining whether there are delinquencies in the business management practices of our company,
including in consultation with our internal auditor or our independent auditor, and making recommendations to the board of directors to improve such practices; (2) determining whether to approve certain
related party transactions (including transactions in which an office holder has a personal interest) and whether any such transaction is an extraordinary or material transaction under the Companies Law;
(3) determining whether a competitive process must be implemented for the approval of certain transactions with controlling shareholders or in which a controlling shareholder has a personal interest
(whether or not the transaction is an extraordinary transaction), under the supervision of the audit committee or other party determined by the audit committee and in accordance with standards determined
by the audit committee, or whether a different process determined by the audit committee should be implemented for the approval of such transactions; (4) determining the process for the approval of
certain transactions with controlling shareholders that the audit committee has determined are not extraordinary transactions but are not immaterial transactions; (5) where the board of directors approves
the work plan of the internal auditor, examining such work plan before its submission to the board of directors and proposing amendments thereto; (6) examining our internal controls and internal
auditor’s performance, including whether the internal auditor has sufficient resources and tools to dispose of its responsibilities; (7) examining the scope of our auditor’s work and compensation and
submitting its recommendation with respect thereto to the corporate body considering the appointment thereof (either the board of directors or the shareholders at the general meeting); and (8) establishing
procedures for the handling of employees’ complaints as to the management of our business and the protection to be provided to such employees.
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Approval of Transactions with Related Parties
The approval of the audit committee is required for specified actions and transactions with office holders and controlling shareholders and their relatives, or in which they have a personal interest.
See “— Fiduciary Duties and Approval of Specified Related Party Transactions under Israeli Law.” The audit committee may not approve an action or a transaction with a controlling shareholder or with
an office holder unless at the time of approval the majority of the members of the audit committee are present, of whom a majority must be independent directors, and at least one of whom is an external
director, provided that this requirement shall not apply if a company has elected to avail itself from the requirement to appoint external directors under the Companies Law in accordance with an
exemption provided under a recent amendment to regulations promulgated under the Companies Law (as described above). The audit committee is also required to determine whether certain related party
transactions are “material” or “extraordinary” for purposes of determining which approvals are required for such transactions.
Compensation Committee
We have a compensation committee consisting of our Dr. Abraham Havron, Mr. Avraham Berger and Mr. Leon Recanati. Dr. Havron serves as the chairman of the compensation committee.
According to the recent amendment to regulations promulgated under the Companies Law described above, an Israeli company whose shares are traded on certain stock exchanges outside Israel
(including the Nasdaq Global Select Market, such as our company) that does not have a controlling shareholder and that complies with the requirements of the laws of the foreign jurisdiction where the
company’s shares are listed, as they apply to domestic issuers, with respect to the appointment of independent directors and the composition of the audit committee and compensation committee, may
elect to exempt itself from the requirements of the Companies Law with respect to (among other things) the composition and meetings of the compensation committee. On January 30, 2017, following
analysis of our qualification to rely on the exemption, our Board of Directors determined to adopt the exemption.
Under Nasdaq listing requirements, we are required to maintain a compensation committee consisting of at least two members, each of whom is an “independent director” under the Nasdaq
listing requirements. Our board of directors has affirmatively determined that each member of our compensation committee qualifies as an “independent director” under the Nasdaq listing requirements.
We rely on the “foreign private issuer exemption” with respect to the Nasdaq requirement to have a formal charter for the compensation committee.
Finance Committee
Our finance committee currently consists of Mr. David Tsur, Mr. Avraham Berger and Mr. Jonathan Hahn. Mr. David Tsur serves as the chairman of the finance committee.
Our finance committee is responsible for considering and making recommendations to the board of directors on the management of our financial resources and financial strategies and
transactions, including our capital structure and corporate finance activities, investment management and financial risk management (including foreign currency exchange and interest rate exposures).
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Strategy Committee
Our strategy committee currently consists of Mr. Jonathan Hahn, who serves as the chairman of the strategy committee, Mr. Leon Recanati, Mr. David Tsur, Ms. Gwen Melincoff, Dr. Michael
Berelowitz and Mr. Asaf Frumerman. Our strategy committee is responsible for assisting our management in carrying out its various responsibilities related to our company’s long-term strategy, financial
initiatives and strategic transactions.
Internal Auditor
Under the Companies Law, the board of directors of a public company must appoint an internal auditor recommended by the audit committee. The role of the internal auditor is, among other
things, to examine whether a company’s actions comply with applicable law and orderly business procedure. Under the Companies Law, the internal auditor may not be an “interested party” or an office
holder, or a relative of an interested party or of an office holder, nor may the internal auditor be the company’s independent accounting firm or anyone acting on its behalf. An “interested party” is defined
in the Companies Law as (i) a holder of 5% or more of the company’s outstanding shares or voting rights, (ii) any person or entity (or relative of such person) who has the right to designate one or more
directors or to designate the chief executive officer of the company, or (iii) any person who serves as a director or as a chief executive officer of the company. Linur Dloomy of Brightman Almagor Zohar
& Co. (a member firm of Deloitte Touche Tohmatsu) serves as our internal auditor.
Fiduciary Duties and Approval of Specified Related Party Transactions under Israeli Law
Fiduciary Duties of Office Holders
The Companies Law codifies the fiduciary duties that office holders owe to a company. Each person listed in the table under “Management — Executive Officers and Directors” is an office
holder under the Companies Law.
An office holder’s fiduciary duties consist of a duty of care and a duty of loyalty. The duty of care requires an office holder to act with the level of care with which a reasonable office holder in
the same position would have acted under the same circumstances. The duty of care includes, among other things, a duty to use reasonable means, in light of the circumstances, to obtain:
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information on the advisability of a given action brought for his or her approval or performed by virtue of his or her position; and
all other important information pertaining to such action.
The duty of loyalty requires an office holder to act in good faith and for the benefit of the company, and includes, among other things, the duty to:
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refrain from any act involving a conflict of interests between the performance of his or her duties to the company and his or her other duties or personal affairs;
refrain from any activity that is competitive with the business of the company;
refrain from exploiting any business opportunity of the company to receive a personal gain for himself or herself or others; and
disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her position as an office holder.
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We may approve an act specified above which would otherwise constitute a breach of the office holder’s duty of loyalty, provided that the office holder acted in good faith, the act or its approval
does not harm the company and the office holder discloses his or her personal interest a sufficient amount of time before the date for discussion of approval of such act.
Disclosure of Personal Interests of an Office Holder and Approval of Transactions
The Companies Law requires that an office holder promptly disclose to the company any “personal interest” that he or she may have, and all related material information or documents relating to
any existing or proposed transaction by the company. A “personal interest” is defined under the Companies Law as the personal interest of a person in an action or in a transaction of the company,
including the personal interest of such person’s relative or of any other corporate entity in which such person and/or such person’s relative is a director, general manager or chief executive officer, a holder
of 5% or more of the outstanding shares or voting rights, or has the right to appoint at least one director or the general manager, but excluding a personal interest arising solely from ownership of shares in
the company. A personal interest includes the personal interest of a person for whom the office holder holds a voting proxy and the personal interest of a person voting as a proxy, even when the person
granting such proxy has no personal interest. An interested office holder’s disclosure must be made promptly and no later than the first meeting of the board of directors at which the transaction is
considered. An office holder is not obliged to disclose such information if the personal interest of the office holder derives solely from the personal interest of his or her relative in a transaction that is not
considered as an “extraordinary transaction.”
An “extraordinary transaction” is defined under the Companies Law as any of the following:
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a transaction other than in the ordinary course of business;
a transaction that is not on market terms; or
a transaction that is likely to have a material impact on the company’s profitability, assets or liabilities.
Under the Companies Law, unless the articles of association of a company provide otherwise, a transaction with an office holder or with a third party in which the office holder has a personal
interest, and which is not an extraordinary transaction, requires approval by the board of directors. Our articles of association do not provide for a different method of approval. If the transaction
considered is an extraordinary transaction with an office holder or third party in which the office holder has a personal interest, then audit committee approval is required prior to approval by the board of
directors. For the approval of compensation arrangements with directors and officers who are controlling shareholders, see “— Disclosures of Personal Interests of a Controlling Shareholder and Approval
of Certain Transactions,” for the approval of compensation arrangements with directors, see “— Compensation of Directors” and for the approval of compensation arrangements with office holders who
are not directors, see “— Compensation of Executive Officers.”
Subject to certain exceptions, any person who has a personal interest in the approval of a transaction that is brought before a meeting of the board of directors or the audit committee may not be
present at the meeting, unless such person is an office holder and invited by the chairman of the board of directors or of the audit committee, as applicable, to present the matter being considered, and may
not vote on the matter. In addition, a director who has a personal interest in the approval of a transaction may be present at the meeting and vote on the matter if a majority of the directors or members of
the audit committee, as applicable, have a personal interest in the transaction. In such case, shareholder approval is also required.
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Disclosure of Personal Interests of a Controlling Shareholder and Approval of Certain Transactions
Pursuant to the Companies Law, the disclosure requirements regarding personal interests that apply to office holders also apply to a controlling shareholder of a public company. For this purpose,
a controlling shareholder is a shareholder who has the ability to direct the activities of a company, including a shareholder who owns 25% or more of the voting rights if no other shareholder owns more
than 50% of the voting rights. Two or more shareholders with a personal interest in the approval of the same transaction are deemed to be one shareholder.
Extraordinary transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, the terms of services provided by a controlling shareholder or his or her
relative, directly or indirectly (including through a corporation controlled by a controlling shareholder), the terms of employment of a controlling shareholder or his or her relative who is employed by the
company and who is not an office holder and the terms of service and employment, including exculpation, indemnification or insurance, of a controlling shareholder or his or her relative who is an office
holder , require the approval of each of the audit committee or the compensation committee with respect to terms of service and employment by the company as an office holder, employee or service
provider, the board of directors and the shareholders, in that order. In addition, the shareholder approval must fulfill one of the following requirements:
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at least a majority of the shares held by shareholders who have no personal interest in the transaction and who are present and voting at the meeting on the matter are voted in favor of
approving the transaction, excluding abstentions; or
the shares voted against the transaction by shareholders who have no personal interest in the transaction who are present and voting at the meeting represent no more than 2% of the
voting rights in the company.
Each shareholder voting on the approval of an extraordinary transaction with a controlling shareholder must inform the company prior to voting whether or not he or she has a personal interest in
the approval of the transaction, otherwise, the shareholder is not eligible to vote on the proposal and his or her vote will not be counted for purposes of the proposal.
Any extraordinary transaction with a controlling shareholder or in which a controlling shareholder has a personal interest with a term of more than three years requires approval every three years,
unless the audit committee determines that the duration of the transaction is reasonable given the circumstances related thereto.
Pursuant to regulations promulgated under the Companies Law, certain transactions with a controlling shareholder or his or her relative, or with directors, relating to terms of service or
employment, that would otherwise require approval of the shareholders may be exempt from shareholder approval upon certain determinations of the audit committee and board of directors.
Duties of Shareholders
Under the Companies Law, a shareholder has a duty to refrain from abusing his or her power in the company and to act in good faith and in a customary manner in exercising its rights and
performing its obligations to the company and other shareholders, including, among other things, when voting at meetings of shareholders on the following matters:
·
·
·
·
an amendment to the company’s articles of association;
an increase in the company’s authorized share capital;
a merger; and
the approval of related party transactions and acts of office holders that require shareholder approval.
112
A shareholder also has a general duty to refrain from discriminating against other shareholders.
In addition, certain shareholders have a duty to act with fairness towards the company. These shareholders include any controlling shareholder, any shareholder who knows that his or her vote can
determine the outcome of a shareholder vote, and any shareholder that, under a company’s articles of association, has the power to appoint or prevent the appointment of an office holder. The Companies
Law does not define the substance of this duty except to state that the remedies generally available upon a breach of contract will also apply in the event of a breach of the duty to act with fairness.
Approval of Significant Private Placements
Under the Companies Law, a significant private placement of securities requires approval by the board of directors and the shareholders by a simple majority. A private placement is considered a
significant private placement if it will cause a person to become a controlling shareholder or if:
·
·
·
the securities issued amount to 20% or more of the company’s outstanding voting rights before the issuance;
some or all of the consideration is other than cash or listed securities or the transaction is not on market terms; and
the transaction will increase the relative holdings of a shareholder who holds 5% or more of the company’s outstanding share capital or voting rights or that will cause any person to
become, as a result of the issuance, a holder of more than 5% of the company’s outstanding share capital or voting rights.
Compensation Policy
Under the Companies Law, a public company is required to adopt a compensation policy, which sets forth the terms of service and employment of office holders, including the grant of any
benefit, payment or undertaking to provide payment, any exemption from liability, insurance or indemnification, and any severance payment or benefit. Such compensation policy must comply with the
requirements of the Companies Law. The compensation policy must be approved at least once every three years, first, by our board of directors, upon recommendation of our compensation committee, and
second, by the shareholders by a special majority.
Our initial compensation policy was approved by our shareholders on January 28, 2014 and amended by our shareholders on June 30, 2015. On August 30, 2016, our shareholders approved and
adopted an amended and restated Compensation Policy, which was amended by our shareholders on November 30, 2017. Our compensation Policy applies to the following office holders: the chief
executive officer, members of our executive management, each person fulfilling such positions even if his or her title is different, and directors. The compensation policy has been drafted and approved in
accordance with the requirements of the Companies Law and determines (among other things) the amount of the compensation of our office holders, its components, the maximum values for the various
components of compensation, and the method for determining compensation.
113
Compensation of Directors
We pay our directors (other than Asaf Frumerman) an annual fee and per-meeting fees in the maximum amounts payable from time to time for such fees by us under the Second and Third
Addendums, respectively (or, to the extent any director is determined to have financial and accounting expertise and is deemed an expert director (in each case, within the meaning of the Companies Law
and the regulations thereunder), under the Fourth Addendum) to the Israeli Companies Regulations (Rules Regarding Compensation and Expense Reimbursement of External Directors), 2000, or the
Compensation Regulations. In accordance with the Compensation Regulations, we currently pay (i) Avraham Berger, a former external director who currently serves as an ordinary (non-external)
director, who is a financial expert under the Companies Law, an annual fee of NIS 114,155 (approximately $32,926), as well as a fee of NIS 4,390 (approximately $1,266) for each board or committee
meeting attended in person, NIS 2,634 (approximately $760) for each board or committee meeting attended via telephone or videoconference and NIS 2,195 (approximately $633) for participation by
written consent; and (ii) our other directors (other than Asaf Frumerman) an annual fee of NIS 85,705 (approximately $24,720), as well as a fee of NIS 3,300 (approximately $952) for each board or
committee meeting attended in person, NIS 1,980 (approximately $571) for each board or committee meeting attended via telephone or videoconference and NIS 1,650 (approximately $476) for
participation by written consent.
We pay Mr. Tsur, in consideration for his services as Active Deputy Chairman on a half-time basis, in which capacity he has served since July 1, 2015, a monthly gross salary of NIS 45,000
(approximately $12,980), in addition to the annual fee and per-meeting fees described above. Mr. Tsur is entitled to annual leave in accordance with Israeli law. Either Mr. Tsur or we may terminate Mr.
Tsur’s engagement as Active Deputy Chairman upon six months prior written notice (payment in lieu of such notice period is permitted at our discretion). In the event of termination of Mr. Tsur’s
engagement as Active Deputy Chairman by us other than for cause, Mr. Tsur shall be entitled to six gross monthly salaries, as well as additional deposits into his manager’s insurance policy.
From time to time, we grant options to directors. Most recently, in accordance with our shareholders’ approval, on November 30, 2017, we granted options to each of our directors serving in such
capacity prior to the 2017 annual general meeting and who were re-elected to serve as directors at the meeting or continued to serve following the meeting. The options shall be exercisable on a cashless
basis based on an exercise price of NIS 21.99 (approximately $6.26) per share (equal to the higher of (i) the average closing price of our ordinary shares on the TASE during the 30 trading days
immediately prior to the approval of the option grant by our board of directors plus 5%; and (ii) the closing price of our ordinary shares on the TASE on the date of the approval of the option grant by our
board of directors). The options will vest over a period of four years in 13 installments: 25% of the options will vest on the first anniversary of the grant date and 6.25% of the remaining options will vest
at the end of each quarter thereafter. The options will be exercisable for 6.5 years following the date of grant and all unexercised options will expire immediately thereafter. The options were granted
under the 2011 Israeli Share Option Plan. The foregoing terms are in accordance with our compensation policy, as amended by our shareholders at the general meeting held on November 30, 2017.
Except with respect to Mr. David Tsur, our Active Deputy Chairman, as described above, there are no arrangements or understandings between us, on the one hand, and any of our directors, on
the other hand, providing for benefits upon termination of their service as directors of our company.
To our knowledge, there are no agreements and arrangements between any director and any third party relating to compensation or other payment in connection with their candidacy or service on
our Board of Directors.
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Under the Companies Law, the compensation (including insurance, indemnification, exculpation and compensation) of our directors requires the approval of our compensation committee, the
subsequent approval of the board of directors and, unless exempted under the regulations promulgated under the Companies Law, the approval of the shareholders at a general meeting. The approval of
the compensation committee and board of directors must be in accordance with the compensation policy. In special circumstances, the compensation committee and board of directors may approve a
compensation arrangement that is inconsistent with the company’s compensation policy, provided that they have considered the same considerations and matters required for the approval of a
compensation policy in accordance with the Companies Law, in which case the approval of the company’s shareholders must be by a special majority (referred to as the “Special Majority for
Compensation”) that requires that either:
·
·
a majority of the shares held by shareholders who are not controlling shareholders and shareholders who do not have a personal interest in such matter and who are present and voting at
the meeting, are voted in favor of approving the compensation package, excluding abstentions; or
the total number of shares voted by non-controlling shareholders and shareholders who do not have a personal interest in such matter that are voted against the compensation package
does not exceed 2% of the aggregate voting rights in the company.
Where the director is also a controlling shareholder, the requirements for approval of transactions with controlling shareholders apply, as described above under “— Disclosure of Personal
Interests of a Controlling Shareholder and Approval of Certain Transactions.”
Compensation of Executive Officers
The aggregate compensation incurred by us in relation to our executive officers and our Active Deputy Chairman of the Board of Directors, including share-based compensation, for the year
ended December 31, 2017, was approximately $3.3 million. This amount includes approximately $110,255 set aside or accrued to provide pension, severance, retirement or similar benefits or expenses,
but does not include business travel, professional and business association dues and expenses reimbursed to executive officers, and other benefits commonly reimbursed or paid by companies in Israel.
The following table presents information regarding compensation accrued in our financial statements for our five most highly compensated office holders (within the meaning of the Companies
Law), namely our Chief Executive Officer, former Deputy Chief Executive Officer and Chief Financial Officer, Clinical Development and Medical Director for Pulmonary Diseases, Vice President,
Research and Development and IP and Vice President, Regulatory Affairs and PVG, as of December 31, 2017.
Name and Position
Salary
Bonus(1)
Value of Options
Granted(2)
(in thousands)
Other(3)
Total
Amir London
Chief Executive Officer
Gil Efron
Former Deputy Chief Executive Officer and Chief Financial Officer
Dr. Naveh Tov
Clinical Development and Medical Director for Pulmonary Diseases
David Tsur
Active Deputy Chairman of the Board of Directors
Eran Nir
Vice President Operations
$
$
$
$
$
293
$
252
$
222
$
210
$
192
$
127
$
146(4) $
39
$
-
$
35
$
79
$
35(5) $
26
$
48
$
31
$
26
$
22
$
21
$
42
$
23
$
525
455
308
300
281
(1)
The annual bonus is subject to the fulfillment of certain targets determined for each year by the compensation committee and board of directors.
115
(2)
(3)
(4)
(5)
The value of options is the expense recorded in our financial statements for the period ended December 31, 2017 with respect to all options granted to such executive officer.
Cost of use of company car.
Includes retirement grant, annual bonus and special bonus for issuance of ordinary shares in an underwritten public offering.
Includes Awards acceleration.
Compensation of Officers Other than the Chief Executive Officer
Pursuant to the Companies Law, the compensation (including insurance, indemnification and exculpation) of a public company’s office holders (other than directors, which is described above,
and the chief executive officer, which is described below) generally requires approval first by the compensation committee and second by the company’s board of directors, according to the company’s
compensation policy. In special circumstances the compensation committee and board of directors may approve a compensation arrangement that is inconsistent with the company’s compensation policy,
provided that they have considered the same considerations and matters required for the approval of a compensation policy in accordance with the Companies Law and such arrangement must be
approved by the company’s shareholders by the Special Majority for Compensation.
However, if the shareholders of the company do not approve a compensation arrangement with an executive officer that is inconsistent with the company’s compensation policy, the compensation
committee and board of directors may, in special circumstances, override the shareholders’ decision, subject to certain conditions.
Under the Companies Law, an amendment to an existing arrangement with an office holder (other than the chief executive officer) who is not a director requires only the approval of the
compensation committee, if the compensation committee determines that the amendment is not material in comparison to the existing arrangement. However, according to regulations promulgated under
the Companies Law, an amendment to an existing arrangement with an office holder (who is not a director) who is subordinate to the chief executive officer shall not require the approval of the
compensation committee, if (i) the amendment is approved by the chief executive officer and the company’s compensation policy determines that a non-material amendment to the terms of service of an
office holder (other than the chief executive officer) will be approved by the chief executive officer and (ii) the engagement terms are consistent with the company’s compensation policy.
Compensation of Chief Executive Officer
The compensation (including insurance, indemnification and exculpation) of a public company’s chief executive officer generally requires the approval of first, the company’s compensation
committee; second, the company’s board of directors; and third (except for limited exceptions), the company’s shareholders by the Special Majority for Compensation.
Under the Companies Law, if the shareholders of the company do not approve the compensation arrangement with the chief executive officer, the compensation committee and board of directors
may override the shareholders’ decision, subject to certain conditions. The compensation committee and board of directors approval should be in accordance with the company’s compensation policy;
however, in special circumstances, they may approve compensation terms of a chief executive officer that are inconsistent with such policy provided that they have considered the same considerations and
matters required for the approval of a compensation policy in accordance with the Companies Law and that shareholder approval was obtained by the Special Majority for Compensation.
Under certain circumstances, the compensation committee and board of directors may waive the shareholder approval requirement in respect of the compensation arrangements with a candidate
for chief executive officer if they determine that the compensation arrangements are consistent with the company’s stated compensation policy.
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However, an amendment to an existing arrangement with an executive officer (who is not a director) requires only the approval of the compensation committee, if the compensation committee
determines that the amendment is not material in comparison to the existing arrangement. Furthermore, according to regulations promulgated under the Companies Law, the renewal or extension of an
existing arrangement with a chief executive officer shall not require shareholder approval if (i) the renewal or extension is not beneficial to the chief executive officer as compared to the prior arrangement
or there is no substantial change in the terms and other relevant circumstances; and (ii) the engagement terms are consistent with the company’s compensation policy and the prior arrangement was
approved by the shareholders by the Special Majority for Compensation.
Where the office holder is also a controlling shareholder, the requirements for approval of transactions with controlling shareholders apply, as described above under “— Disclosure of Personal
Interests of a Controlling Shareholders and Approval of Certain Transactions.”
Exculpation, Insurance and Indemnification of Office Holders
Under the Companies Law, a company may not exculpate an office holder from liability for a breach of the duty of loyalty. An Israeli company may exculpate an office holder in advance from
liability to the company, in whole or in part, for damages caused to the company as a result of a breach of duty of care, but only if a provision authorizing such exculpation is included in the company’s
articles of association. Our articles of association include such a provision. However, we may not exculpate an office holder for an action or transaction in which a controlling shareholder or any other
office holder (including an office holder who is not the office holder we have undertaken to exculpate) has a personal interest (within the meaning of the Companies Law). We may also not exculpate in
advance a director from liability arising out of a prohibited dividend or distribution to shareholders.
Under the Companies Law, a company may indemnify an office holder for the following liabilities, payments and expenses incurred for acts performed by him or her, as an office holder, either
pursuant to an undertaking given by the company in advance of the act or following the act, provided its articles of association authorize such indemnification:
·
·
·
a monetary liability imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator’s award approved by a court. However, if an
undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of
directors, can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount, or according to criteria, determined by the board of directors
as reasonable under the circumstances. Such undertaking shall detail the foreseen events and amount or criteria mentioned above;
reasonable litigation expenses, including reasonable attorneys’ fees, incurred by the office holder (1) as a result of an investigation or proceeding instituted against him or her by an
authority authorized to conduct such investigation or proceeding, provided that (i) no indictment was filed against such office holder as a result of such investigation or proceeding; and
(ii) no financial liability was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed,
it was imposed with respect to an offense that does not require proof of criminal intent (mens rea); and (2) in connection with a monetary sanction; and
reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf, or
by a third party, or in connection with criminal proceedings in which the office holder was acquitted, or as a result of a conviction for an offense that does not require proof of criminal
intent (mens rea).
117
In addition, under the Companies Law, a company may insure an office holder against the following liabilities incurred for acts performed by him or her as an office holder, to the extent provided
in the company’s articles of association:
·
·
·
a breach of a duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;
a breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder; and
a monetary liability imposed on the office holder in favor of a third party.
Under the Companies Law, a company may not indemnify, exculpate or insure an office holder against any of the following:
·
·
·
·
a breach of the duty of loyalty, except for indemnification and insurance for a breach of the duty of loyalty to the company to the extent that the office holder acted in good faith and had
a reasonable basis to believe that the act would not harm the company;
a breach of the duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;
an act or omission committed with intent to derive illegal personal benefit; or
a fine or penalty levied against the office holder.
For the approval of exculpation, indemnification and insurance of office holders who are directors, see “— Compensation of Directors,” for the approval of exculpation, indemnification and
insurance of office holders who are not directors, see “—Compensation of Executive Officers” and for the approval of exculpation, indemnification and insurance of office holders who are controlling
shareholders, see “— Fiduciary Duties and Approval of Specified Related Party Transactions under Israeli Law — Disclosure of Personal Interests of a Controlling Shareholder and Approval of Certain
Transactions.”
Our articles of association permit us to exculpate, indemnify and insure our office holders to the fullest extent permitted under the Companies Law (other than indemnification for litigation
expenses in connection with a monetary sanction); provided that we may not exculpate an office holder for an action or transaction in which a controlling shareholder or any other office holder (including
an office holder who is not the office holder we have undertaken to exculpate) has a personal interest (within the meaning of the Companies Law).
We have entered into indemnification and exculpation agreements with each of our current office holders exculpating them from a breach of their duty of care to us to the fullest extent permitted
by the Companies Law (provided that we may not exculpate an office holder for an action or transaction in which a controlling shareholder or any other office holder (including an office holder who is not
the office holder we have undertaken to exculpate) has a personal interest (within the meaning of the Companies Law)) and undertaking to indemnify them to the fullest extent permitted by the Companies
Law (other than indemnification for litigation expenses in connection with a monetary sanction), to the extent that these liabilities are not covered by insurance. This indemnification is limited to events
determined as foreseeable by our board of directors based on our activities, as set forth in the indemnification agreements. Under such agreements, the maximum aggregate amount of indemnification that
we may pay to all of our office holders together is (i) for office holders who joined our company before May 31, 2013, the greater of 30% of the shareholders equity according to our most recent financial
statements (audited or reviewed) at the time of payment and NIS 20 million, and (ii) for office holders who joined our company after May 31, 2013, 25% of the shareholders equity according to our most
recent financial statements (audited or reviewed) at the time of payment.
118
We are not aware of any pending or threatened litigation or proceeding involving any of our office holders as to which indemnification is being sought, nor are we aware of any pending or
threatened litigation that may result in claims for indemnification by any office holder.
Agreements with Five Most Highly Compensated Senior Office Holders
We have entered into agreements with each of our five most highly compensated office holders (within the meaning of the Companies Law), listed below. The terms of employment or service of
such office holders are directed by our compensation policy. See “— Compensation Policy.” Each of these agreements contains provisions regarding non-competition, confidentiality of information and
assignment of inventions. The non-competition provision applies for a period that is generally 12 months following termination of employment. The enforceability of covenants not to compete in Israel
and the United States is subject to limitations. Except for David Tsur, our Active Deputy Chairman, such office holders are entitled to an annual bonus subject to the fulfillment of certain targets
determined for each year by the compensation committee and board of directors (for our chief executive officer) and by our chief executive officer (for the other office holders. In addition, all such
executive officers are entitled to a company car, as well as sick pay, convalescence pay, manager’s insurance and a study fund (“keren hishtalmut”), all in accordance with Israeli law, and annual leave.
Amir London, Chief Executive Officer. Mr. London has served as our Chief Executive Officer since July 2015. Prior to that and effective as of December 1, 2013, Mr. London served as our Vice
President, Business Development. Mr. London’s engagement terms as our Chief Executive Officer have been approved by our Compensation Committee, the Board of Directors and our shareholders.
According to the terms of the agreement, either party may terminate the agreement at any time upon three months' prior written notice to the other party, and we may terminate the agreement immediately
for cause in accordance with Israeli law.
Gil Efron, Former Deputy Chief Executive Officer and Chief Financial Officer. Mr. Efron served as our Deputy Chief Executive from July 2015 until November 30, 2017, along with the position
of Chief Financial Officer in which he served from 2011. Effective as of September 1, 2011, we entered into an employment agreement with Mr. Efron with respect to his employment as our chief
financial officer, which terminated on November 30, 2017. Following November 30, 2017, Mr. Efron shall remain employed by us until March 31, 2018.
Dr. Naveh Tov, Vice President, Clinical Development and Medical Director for Pulmonary Diseases. Effective as of July 2016, we entered into an employment agreement with Dr. Naveh Tov
with respect to his employment as our Vice President, Clinical Development and Medical Director for Pulmonary Diseases. Either party may terminate the agreement at any time upon three months' prior
written notice to the other party, and we may terminate the agreement immediately for cause in accordance with Israeli law.
David Tsur, Active Deputy Chairman of the Board of Directors. Mr. Tsur has served as our Active Deputy Chairman of the Board of Directors since July 2015, on a half-time basis. Prior to that,
Mr. Tsur served as our Chief Executive Officer and a director since our inception. Mr. Tsur’s engagement terms as our Active Deputy Chairman have been approved by our Compensation Committee, the
Board of Directors and our shareholders. According to the terms of the agreement, either party may terminate the agreement at any time upon six months' prior written notice to the other party (payment in
lieu of such notice period is permitted at our discretion), and we may terminate the agreement immediately for cause in accordance with Israeli law. In addition, in the event of termination of Mr. Tsur’s
engagement as Active Deputy Chairman by us other than for cause, Mr. Tsur shall be entitled to six gross monthly salaries, as well as additional deposits into his manager’s insurance policy.
119
Eran Nir, Vice President Operations. Effective as of November 1, 2016, we entered into an employment agreement with Mr. Eran Nir with respect to his employment as our Vice President,
Operations. Either party may terminate the agreement at any time upon two months' prior written notice to the other party, and we may terminate the agreement immediately for cause in accordance with
Israeli law.
Other Executive Officers
We have entered into written employment agreements with the rest of our executive officers. The terms of employment of our executive office holders are directed by our compensation policy.
See “— Compensation Policy.” Each of these agreements contains provisions regarding non-competition, confidentiality of information and assignment of inventions. The non-competition provision
applies for a period that is generally 12 months following termination of employment. The enforceability of covenants not to compete in Israel and the United States is subject to limitations. In addition,
we are required to provide up to three months’ notice prior to terminating the employment of such executive officers, other than in the case of a termination for cause. Each of our employment agreements
with such executive officers provides for annual bonuses, which are subject to the fulfillment of certain targets determined for each year, and the executive officers are also entitled to special bonuses upon
the achievement of certain company milestones.
Employees
As of December 31, 2017, we employed 413 employees, according to the following division: 199 in Operations, 104 in Quality, 21 in Research and Development, 20 in Regulation, 16 in
Business Development, 12 in Medical & Clinical, 16 in Human Resources & Administration and 25 in Finance (our Procurement Department merged into the Finance department). As of December 31,
2016, we employed 377 employees, according to the following division: 193 in Operations (including Procurement Department), 92 in Quality, 19 in Research and Development, 19 in Regulation, 17 in
Business Development, 8 in Medical, 14 in Human Resources and 15 in Finance. As of December 31, 2015, we employed 319 full-time employees, according to the following division: 159 in Operations
(including Procurement Department), 79 in Quality, 18 in Research and Development, 17 in Regulation, 14 in Business Development, 8 in Medical, 10 in Human Resources and 14 in Finance. As of
December 31, 2017, 2016 and 2015, all of our employees were located in Israel.
We signed a collective bargaining agreement with the Histadrut (General Federation of Labor in Israel) and the employees’ committee established by our employees at our Beit Kama facility in
December 2013, which expired in December 2017. Approximately 55% of our employees, all of whom are located at our Beit Kama facility, currently work under the collective bargaining agreement
signed in December 2013. The collective bargaining agreement governs certain aspects of our employee-employer relations, such as: firing procedures, annual salary raise, eligibility for certain
compensation terms and welfare. We are currently in the process of negotiating the renewal of the collective bargaining agreement.
Israeli labor laws govern the length of the workday, minimum wages for employees, procedures for hiring and dismissing employees, determination of severance pay, annual leave, sick days,
advance notice of termination of employment, equal opportunity and anti-discrimination laws and other conditions of employment. Subject to certain exceptions, Israeli law generally requires severance
pay upon the retirement, death or dismissal of an employee, and requires us and our employees to make payments to the National Insurance Institute, which is similar to the U.S. Social Security
Administration. Our employees have defined benefit pension plans that comply with the applicable Israeli legal requirements.
Extension orders issued by the Israel Ministry of Economy and Industry (formerly named the Ministry of Industry, Trade and Labor) apply to us and affect matters such as cost of living
adjustments to payroll, length of working hours and week, recuperation pay, travel expenses, and pension rights.
120
Share Ownership
The following table sets forth information with respect to the beneficial ownership of our ordinary shares by each of our directors and executive officers and all of current directors and executive
officers as a group.
The percentage of beneficial ownership of our ordinary shares is based on 40,262,819 ordinary shares outstanding as of March 5, 2018 Beneficial ownership is determined in accordance with the
rules of the SEC and generally includes voting power or investment power with respect to securities. All options exercisable into ordinary shares within 60 days of the date of this Annual Report are
deemed to be outstanding and beneficially owned by the shareholder holding such options for the purpose of computing the number of shares beneficially owned by such shareholder. They are not,
however, deemed to be outstanding and beneficially owned for the purpose of computing the percentage ownership of any other shareholder.
Name
Amir London (1)
Chaime Orlev (2)
Dr. Liliana Bar (3)
Yael Brenner (4)
Shani Dotan (5)
Eran Nir (6)
Orit Pinchuk (7)
Dr. Michal Stein (8)
Dr. Naveh Tov (9)
Leon Recanati (10)
David Tsur (11)
Dr. Michael Berelowitz (12)
Avraham Berger (13)
Asaf Frumerman (14)
Jonathan Hahn (15)
Dr. Abraham Havron (16)
Prof. Itzhak Krinsky, Ph.D
Gwen A. Melincoff
Shmuel (Milky) Rubinstein
Directors and Executive Officers as a group (19 persons)
________
* Less than 1% of our ordinary shares.
Number
Percentage
137,375
4,166
40,625
26,042
37,917
10,739
30,917
4,167
19,928
4,021,248
1,147,537
2,188
2,188
-
3,668,089
23,930
5,250
-
4,383
9,186,689
*
-
*
*
*
*
*
*
*
9.1%
2.8%
-
-
-
8.3%
*
*
-
*
18.6%
(1)
(2)
(3)
Includes 12,000 restricted shares and options to purchase 125,375 ordinary shares exercisable within 60 days of the date of this Annual Report, at a weighted average exercise price of NIS
26.90 (or $7.76) per share, which expire between May 15, 2020 and May 30, 2024. Does not include unvested options to purchase 58,125 ordinary shares that are not exercisable within 60
days of this Annual Report.
Represents 4,166 restricted shares. Does not include unvested options to purchase 12,500 ordinary shares that are not exercisable within 60 days of this Annual Report.
Includes options to purchase 40,625 ordinary shares exercisable within 60 days of the date of this Annual Report, at a weighted average exercise price of NIS 40.80 (or $11.77) per share,
which expire between February 28, 2019 and October 27, 2023. Does not include unvested options to purchase 1,875 ordinary shares that are not exercisable within 60 days of this Annual
Report.
121
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
Includes 4,667 restricted shares and options to purchase 21,375 ordinary shares exercisable within 60 days of the date of this Annual Report, at a weighted average exercise price of NIS
18.31 (or $5.28) per share, which expire between October 27, 2021 and January 31, 2024. Does not include unvested options to purchase 17,625 ordinary shares that are not exercisable
within 60 days of this Annual Report.
Includes 4,667 restricted shares and options to purchase 33,250 ordinary shares exercisable within 60 days of the date of this Annual Report, at an exercise price of NIS 47.18 (or $13.61) per
share, which expire between October 27, 2021 and January 31, 2024. Does not include unvested options to purchase 13,250 ordinary shares that are not exercisable within 60 days of this
Annual Report.
Represents 6,833 restricted shares and options to purchase 3,906 ordinary shares exercisable within 60 days of the date of this Annual Report, at an exercise price of NIS 22.08 (or $6.37) per
share, which expire between May 24, 2023 and January 31, 2024.. Does not include unvested options to purchase 16,594 ordinary shares that are not exercisable within 60 days of this
Annual Report.
Includes 2,667 restricted shares and options to purchase 28,250 ordinary shares exercisable within 60 days of the date of this Annual Report, at an exercise price of NIS 43.86 (or $12.65) per
share, which expire between July 13, 2020 and January 31, 2024. Does not include unvested options to purchase 13,250 ordinary shares that are not exercisable within 60 days of this Annual
Report.
Represents 4,167 restricted shares. Does not include unvested options to purchase 12,500 ordinary shares that are not exercisable within 60 days of this Annual Report.
Includes 6,834 restricted shares and options to purchase 13,094 ordinary shares exercisable within 60 days of the date of this Annual Report, at an exercise price of NIS 31.85 (or $9.19) per
share, which expire between May 14, 2020 and January 31, 2024. Does not include unvested options to purchase 23,406 ordinary shares that are not exercisable within 60 days of this Annual
Report.
Mr. Recanati holds 677,479 ordinary shares directly and 3,295,644 ordinary shares indirectly through Gov. Gov is wholly-owned by Mr. Recanati, the Chairman of our board of directors,
who exercises sole voting and investment power over the shares held by Gov. In addition includes options to purchase 48,125 ordinary shares exercisable within 60 days of the date of this
Annual Report, at an exercise price of NIS 50.17 (or $14.47) per share, which expire between May 14, 2020 and May 30, 2024. Does not include unvested options to purchase 11,875
ordinary shares that are not exercisable within 60 days of this Annual Report.
Mr. David Tsur directly holds 771,287 ordinary shares and options to purchase 376,250 ordinary shares exercisable within 60 days of the date of this Annual Report, at a weighted average
exercise price of NIS 43.94 (or $12.67) per share, which expire between June 8, 2018 and March 2, 2023. Does not include unvested options to purchase 5,625 ordinary shares that are not
exercisable within 60 days of this Annual Report.
Includes options to purchase 2,188 ordinary shares exercisable within 60 days of the date of this Annual Report, at a weighted average exercise price of NIS 15.20 (or $4.38) per share, which
expire between March 2, 2023 and May 30, 2024. Does not include unvested options to purchase 7,813 ordinary shares that are not exercisable within 60 days of this Annual Report.
Includes options to purchase 2,188 ordinary shares exercisable within 60 days of the date of this Annual Report, at a weighted average exercise price of NIS 15.20 (or $4.38) per share, which
expire at March 2, 2023 and May 30, 2024. Does not include unvested options to purchase 7,813 ordinary shares that are not exercisable within 60 days of this Annual Report.
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(14)
(15)
We were informed by Mr. Frumerman that he is a partner at Brosh Capital Partners L.P. For information regarding the holdings of the Brosh Capital Partners group, see “Item 7. Major
Shareholders and Related Party Transactions — Major Shareholders.”
Mr. Jonathan Hahn directly holds 313,841 ordinary shares and options to purchase 25,938 ordinary shares exercisable within 60 days of this Annual Report, at an exercise price of NIS 47.90
(or $13.82) per share, which expire between May 14, 2020 and May 5, 2024. In addition, we were informed that Mr. Hahn holds 25% of the shares of Sinara Financing S.A. (“Sinara”),
which holds 100% of the shares of Damar Chemicals Inc. (“Damar”), which directly holds 2,751,661 ordinary shares. We were informed that additional 50% of the shares of Sinara are held
by Mr. Hahn’s siblings, who also directly hold an aggregate 576,649 ordinary shares. Does not include unvested options to purchase 9,063 ordinary shares that are not exercisable within 60
days of this Annual Report.
(16)
Includes 1,742 shares owned by Operon Consultants Ltd., which is wholly-owned by Dr. Havron. Dr. Havron also holds options to purchase 22,188 ordinary shares exercisable within 60
days of the date of this Annual Report, at an exercise price of NIS 52.82 (or $15.24) per share, which expire between May 14, 2020 and March 02, 2023. Does not include unvested options
to purchase 2,813 ordinary shares that are not exercisable within 60 days of this Annual Report.
Equity Compensation Plans
In 2005, we adopted our 2005 Israeli Share Option Plan (the “2005 Plan”). We ceased to grant options under the 2005 Plan in 2010 and the 2005 Plan expired on July 5, 2015.
In July 2011, we adopted our 2011 Israeli Share Option Plan and in September 2016, we amended and renamed it as the 2011 Israeli Share Award Plan (the “2011 Plan”). Under the 2011 Plan,
we are authorized to grant options and restricted shares to directors, officers, employees, consultants and service providers of our company and subsidiaries. The 2011 Plan is intended to enhance our
ability to attract and retain desirable individuals by increasing their ownership interests in us. The 2011 Plan, which is effective until July 23, 2021, is designed to reflect the provisions of the Israeli Tax
Ordinance, which affords certain tax advantages to Israeli employees, officers and directors that are granted options in accordance with its terms. The 2011 Plan may be administered by our board of
directors either directly or upon the recommendation of the compensation committee.
We have granted options to our employees, officers and directors under the 2011 Plan. Each option granted under the 2011 Plan entitles the grantee to purchase one of our ordinary shares. In
general, the exercise price of each option granted under the 2011 Plan is equal to the average closing price of our ordinary shares on the TASE during the 30-TASE trading days immediately prior to board
approval of the grant of such options. The exercise price of options granted to directors and officers under the 2011 Plan is equal to the closing price of our ordinary shares on the TASE during the 30-
TASE trading days immediately prior to board approval of the grant of such options plus 5%. Options granted under the 2011 Plan are exercised by way of cashless exercise and accordingly, the grantee is
not required to pay the exercise price when exercising the options and instead, receives upon exercise such number of ordinary shares with a total fair market value equal to the difference between the total
fair market value of the ordinary shares underlying the exercised options and the total purchase price for such options.
The options granted under the 2011 Plan generally vest during a four-year period following the date of the grant in 13 installments: 25% of the options vest on the first anniversary of the grant
date and 6.25% of the remaining options vest at the end of each quarter thereafter. Options granted under the 2011 Plan are generally exercisable for 6.5 years following the date of grant and all
unexercised options will expire immediately thereafter. Options that have vested prior to the end of a grantee’s employment or services agreement with us may generally be exercised within 90 days from
the end of such grantee’s employment or services with us, unless such relationship was terminated for cause. Options which are not exercised during such 90-day period expire at the end of the period,
unless all of the 90-day period is a black-out period during which time the options may not be exercised, in which case our Chief Executive Officer or Chief Financial Officer is entitled to extend the
exercise period for specified periods. Options that have not vested on the date of the end of a grantee’s employment or services agreement with us, and, in the event of termination of employment or
services for cause, all unexercised options (whether vested or not), expire immediately upon termination.
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Beginning in 2016, we have also granted restricted shares to our officers. The restricted shares awarded under the 2011 Plan generally vest over a period of four years in 13 installments: 25% of
the restricted shares vest on the first anniversary of the grant date and 6.25% of the remaining restricted shares vest at the end of each quarter thereafter.
In the event of certain transactions, such as our being acquired, or a merger or reorganization or a sale of all or substantially all of our assets, awards then outstanding under the 2011 Plan shall be
assumed or substituted for shares or other securities of the surviving or acquiring entity as were distributed to our shareholders in connection and the transaction, subject to an appropriate adjustment to the
exercise price (if applicable). The board or the compensation committee may determine that the terms of certain awards under the 2011 Plan include a provision that their vesting schedules will be
accelerated such that they will be exercisable prior to the closing of such a transaction, if the awards are not assumed or substituted by the successor company.
Options and restricted shares granted to our employees under the 2011 Plan were granted pursuant to the provisions of Section 102 of the Israeli Income Tax Ordinance, under the capital gains
alternative. In order to comply with the capital gains alternative, all such options and restricted shares under the 2011 Plan are granted or issued to a trustee and are to be held by the trustee for at least two
years from the date of grant. Under the capital gains alternative, we are not allowed an Israeli tax deduction for the grant of the options or issuance of the shares issuable thereunder.
On April 27, 2015, our board of directors approved an increase in the number of ordinary shares reserved for issuance under the 2011 Plan by 500,000 ordinary shares, on May 8, 2016, our board
of directors approved a further increase in the number of ordinary shares reserved for issuance under the 2011 Plan by an additional 200,000 shares, and on December 14, 2017, our board of directors
approved a further increase in the number of ordinary shares reserved for issuance under the 2011 Plan by an additional 760,000 shares. As of December 31, 2017, an aggregate of 530,660 ordinary shares
were reserved for future issuance under the 2011 Plan (subject to certain adjustments specified in the 2011 Plan), and options to purchase 2,572,372 ordinary shares were outstanding under the 2011 Plan
and 76,512 restricted shares were outstanding under the 2011 Plan. Any ordinary shares underlying options that expire prior to exercise or restricted shares that are forfeited under the 2011 Plan will
become again available for issuance under the 2011 Plan.
Item 7. Major Shareholders and Related Party Transactions
Major Shareholders
The following table sets forth information with respect to the beneficial ownership of our ordinary shares by each person known to us to own beneficially more than 5% of our ordinary shares.
The percentage of beneficial ownership of our ordinary shares is based on 40,262,819 ordinary shares outstanding as of March 6, 2018. Beneficial ownership is determined in accordance with the
rules of the SEC and generally includes voting power or investment power with respect to securities. All options exercisable into ordinary shares within 60 days of the date of this Annual Report are
deemed to be outstanding and beneficially owned by the shareholder holding such options for the purpose of computing the number of shares beneficially owned by such shareholder. They are not,
however, deemed to be outstanding and beneficially owned for the purpose of computing the percentage ownership of any other shareholder.
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Except as described in the footnotes below, we believe each shareholder has voting and investment power with respect to the ordinary shares indicated in the table as beneficially owned.
Name
Meitav Dash Group (1)
Leon Recanati (2)
Hahn Family (3)
Brosh Capital Partners L.P (4).
The Phoenix Holding Ltd. (5)
_________________
Number
Percentage
3,691,595
4,021,248
3,668,089
3,094,721
2,785,010
9.2%
9.1%
8.3%
7.7%
6.9%
(1) Based solely upon, and qualified in its entirety with reference to, Schedule 13G filed with the SEC on January 8, 2018. According to the Schedule 13G, 2,803,229 of the ordinary shares are
beneficially owned by provident funds of Meitav Dash Investments Ltd. group (“Meitav Dash Group”), 447,942 of the ordinary shares are beneficially owned by mutual of funds of the Meitav Dash
Group and 440,424 of the ordinary shares are beneficially owned by ETFs of the Meitav Dash Group.
(2) Mr. Recanati holds 677,479 ordinary shares directly and 3,295,644 ordinary shares indirectly through Gov. Gov is wholly-owned by Mr. Recanati, the Chairman of our board of directors, who
exercises sole voting and investment power over the shares held by Gov. In addition, Mr. Recanati holds options to purchase 48,125 ordinary shares exercisable within 60 days of this Annual Report
at an exercise price of NIS 50.17 (or $14.47 per share, which expire between May 14, 2020 and May 30, 2024. Does not include unvested options to purchase 11,875 ordinary shares that are not
exercisable within 60 days of this Annual Report.
(3) Mr. Jonathan Hahn directly holds 313,841 ordinary shares and options to purchase 25,938 ordinary shares exercisable within 60 days of this Annual Report, at an exercise price of NIS 47.9 (or
$13.82) per share, which expire between May 14, 2020 and May 30, 2024. In addition, we were informed that Mr. Hahn holds 25% of the shares of Sinara Financing S.A. (“Sinara”), which holds
100% of the shares of Damar Chemicals Inc. (“Damar”), which directly holds 2,751,661 ordinary shares. We were informed that an additional 50% of the shares of Sinara are held by Mr. Hahn’s
siblings, who also directly hold an aggregate of 576,649 ordinary shares. Does not include unvested options to purchase 9,063 ordinary shares directly held by Mr. Jonathan Hahn that are not
exercisable within 60 days of this Annual Report.
(4) Based solely upon, and qualified in its entirety with reference to, Amendment No. 2 to Schedule 13D filed with the SEC on November 13, 2017. According to the Schedule 13D/A, (a) Brosh Capital
Partners, L.P., a Cayman Islands limited partnership (“Brosh”), beneficially owns 2,411,175 ordinary shares; (b) Exodus Management Israel Ltd., as the general partner of Brosh (“Exodus GP”) and as
portfolio manager for a certain managed account (the “Exodus Managed Account”), may be deemed the beneficial owner of the (i) 2,411,175 ordinary shares directly owned by Brosh and (ii) 155,719
ordinary shares held in the Exodus Managed Account; (c) Mr. Amir Efrati, as the portfolio manager of each of Brosh and Exodus GP and because of certain Power of Attorney Agreements between
him and each of Mr. Aharon Biram and Ms. Esther Deutsch, may be deemed the beneficial owner of the (i) 2,411,175 ordinary shares owned by Brosh, (ii) 155,719 ordinary shares held in the Exodus
Managed Account, (iii) 233,663 ordinary shares owned by Mr. Biram and (iv) 294,174 ordinary shares owned by Ms. Deutsch; (d) Mr. Aharon Biram beneficially owns 233,653 ordinary shares; and
(e) Ms. Esther Deutsch beneficially owns 294,174 ordinary shares.
(5) Based solely upon, and qualified in its entirety with reference to, Amendment No. 3 to Schedule 13G filed with the SEC on February 20, 2018. According to the Schedule 13G/A, the shares are
beneficially owned by various direct or indirect, majority or wholly-owned subsidiaries of the Phoenix Holding Ltd. The Phoenix Holding Ltd. is a majority-owned subsidiary of Delek Group
Ltd. The majority of Delek Group Ltd.’s outstanding shares and voting rights are owned, directly and indirectly, by Itshak Sharon (Tshuva) through private companies wholly-owned by him, and the
remainder is held by the public.
Each of the reporting persons disclaims beneficial ownership of the reported shares in excess of their actual pecuniary interest therein. To our knowledge, based on information provided to us by
our transfer agent in the United States, as of March 2, 2018, we had one shareholder of record who was registered with an address in the United States, holding approximately 25.5% of our outstanding
ordinary shares. Such number is not representative of the portion of our shares held in the United States nor is it representative of the number of beneficial holders residing in the United States, since such
ordinary shares were held of record by one U.S. nominee company, CEDE & Co.
125
To our knowledge, the only significant changes in the percentage ownership held by our major shareholders during the past three years have been the following: From January 1, 2015 to the date
of this Annual Report, the ownership percentage of Hahn family decreased by 4.0% from 12.35% to 8.35%. Mr. Leon Recanati's ownership percentage decreased by 1.96% from 11.04% to 9.08% during
such period. The Phoenix Holdings Group ownership percentage decreased by 0.16% from 7.06% to 6.90% during such period. The DS Apex group’s ownership percentage increased by 1.93% from
7.22% to 9.15% during such period. The Brosh Capital Partners group’s ownership percentage increased from less than 5% to 7.7% during such period.
None of our shareholders has different voting rights from other shareholders. We are not aware of any arrangement that may, at a subsequent date, result in a change of control of our company.
Related Party Transactions
Tuteur S.A.C.I.F.I.A.
In August 2011, we entered into a distribution agreement with Tuteur that amends and restates a distribution agreement we entered into in November 2001. Tuteur is a company organized under
the laws of Argentina and was formerly controlled by Mr. Ralf Hahn, the former Chairman of our board of directors. Mr. Hahn’s son, Mr. Jonathan Hahn, a director, is currently the President and a
director of Tuteur. The amendment to the agreement was made as an arm’s length transaction, in connection with the expected completion of Glassia’s registration in Argentina and the commencement of
its marketing in Argentina. On August 19, 2014, we entered into an amendment to the distribution agreement in order to add KamRho(D) as an additional product to be distributed by Tuteur and expanded
the territories to include Bolivia. Pursuant to the distribution agreement, as amended, Tuteur serves as the exclusive distributor of Glassia and KamRho(D), in Argentina, Paraguay and Bolivia. Tuteur is
obligated under the agreement to commence marketing, sales and distribution of the products within each country covered by the agreement within two months after the grant of regulatory approval in
each such country. Commencing the second year following the date that Tuteur commences sales of the product in Argentina, Tuteur will be obligated to purchase minimum amounts of products in the
territories, in the total annual amount of not less than $1,006,800. In 2016, Tuteur was awarded a one-time success bonus in the amount of $100,000 based on achieving certain sales targets in 2015. In
2016, our board of directors approved the payment to Tuteur of a non-material amount to be used for the purpose of marketing activities aimed at locating new AATD patients and increasing the overall
number of AATD patients treated with Glassia in Argentina. Such amount will be paid in several installments, according to Tuteur's actual expenses for such purpose, until the end of September 2019.
Tuteur shall cease to have exclusivity if it fails to comply with the minimum purchase requirement in each of the countries, on a country by country basis. Pursuant to the agreement, Tuteur is
obligated to obtain the relevant regulatory approvals and reimbursement in each of the countries within 18 months of receiving the required registration documents from us. Glassia was approved by
regulators in Argentina in July 2012. Glassia has not yet been submitted and approved by regulators in Paraguay or Bolivia. The parties have agreed to separately negotiate the allocation of any costs
relating to clinical trials or studies required by relevant regulatory authorities in the applicable territory. We retain ownership of all relevant intellectual property.
The distribution agreement expires on December 31, 2019, provided that with respect to distribution in Bolivia, the agreement expires on the fifth anniversary of the date that Tuteur commences
sales of a product in Bolivia. We are entitled to terminate the agreement upon 30 days’ notice if a third party acquires more than 50% of the common stock or voting rights of Tuteur or Tuteur fails to
receive the relevant regulatory approvals within the required time. Either party can terminate the agreement upon bankruptcy of the other party, a material breach of the agreement by the other party after a
30-day cure period and non-performance as a result of force majeure for more than two months. Our board of directors and audit committee approved the agreement and the amendments thereto and
determined that each was not an “extraordinary transaction” within the meaning of the Companies Law.
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Khairi S.A.
On June 4, 2016, we entered into a distribution agreement with Khairi S.A. (“Khairi”) for the distribution by Khairi of Glassia and KamRho(D) in Uruguay. Distribution rights for Glassia and
KamRho(D) in Uruguay were originally granted to Tuteur; however, as Tuteur is not incorporated in Uruguay, according to local regulatory requirements its ability to distribute pharmaceutical products in
Uruguay is limited, while Khairi, which is located in the free trading zone in Uruguay, is not so limited. The distribution agreement with Khairi is an arm’s length transaction, based on the terms of the
distribution agreement previously signed with Tuteur. Mr. Leon Recanati (the Chairman of our board of directors), Mr. Jonathan Hahn (a director) and his siblings and Mr. Reuven Behar (who served as a
director from April 2013 until May 2016) are shareholders of Khairi. Mr. Reuven Behar serves as the chairman of the board of directors of Khairi. In 2015 and 2016, Khari distributed our AAT product
in Cuba in a non-material amount. In 2017, Khairi did not distribute any of our products. Our audit committee and board of directors approved the engagement of Khairi in accordance with the Companies
Law.
Fischer Behar Chen Well Orion & Co.
Since our initial public offering on the Tel Aviv Stock Exchange in 2005, we have retained the services of Fischer Behar Chen Well Orion & Co as our Israeli counsel. Mr. Reuven Behar, who
served as a director from April 2013 until May 2016 is a partner at Fischer Behar Chen Well Orion & Co.
Indemnification Agreements
We have entered into indemnification and exculpation agreements with each of our current officers and directors, exculpating them from a breach of their duty of care to us to the fullest extent
permitted by the Companies Law (provided that we may not exculpate an office holder for an action or transaction in which a controlling shareholder or any other office holder (including an office holder
who is not the office holder we have undertaken to exculpate) has a personal interest (within the meaning of the Companies Law)) and undertaking to indemnify them to the fullest extent permitted by the
Companies Law (other than indemnification for litigation expenses in connection with a monetary sanction), including with respect to liabilities resulting from our initial public offering in the United
States, to the extent such liabilities are not covered by insurance. See “Item 6. Directors, Senior Management and Employees — Exculpation, Insurance and Indemnification of Office Holders.”
Employment Agreements
We have entered into employment agreements with our executive officers and key employees, which are terminable by either party for any reason. The employment agreements contain standard
provisions, including assignment of invention provisions and non-competition clauses. See “Item 6. Directors, Senior Management and Employees — Employment Agreements with Executive Officers.”
Shareholders’ Agreement
Under a shareholders' agreement entered into on March 4, 2013, the Recanati Group, on the one hand, and the Damar Group, on the other hand, have each agreed to vote the ordinary shares
beneficially owned by them in favor of the election of director nominees designated by the other group as follows: (i) three director nominees, so long as the other group beneficially owns at least 7.5% of
our outstanding share capital, (ii) two director nominees, so long as the other group beneficially owns at least 5.0% (but less than 7.5%) of our outstanding share capital, and (iii) one director nominee, so
long as the other group beneficially owns at least 2.5% (but less than 5.0%) of our outstanding share capital. In addition, to the extent that after the designation of the foregoing director nominees there are
additional director vacancies, each of the Recanati Group and Damar Group have agreed to vote the ordinary shares beneficially owned by them in favor of such additional director nominees designated
by the party who beneficially owns the larger voting rights in our company.
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Registration Rights Agreement
We entered into a registration rights agreement on April 14, 2013 with Damar, Leon Recanati, Gov and David Tsur (collectively, the “Holders”), pursuant to which our ordinary shares held by
them at such time, or that may be held in the future by the Holders and their respective affiliates, are entitled to certain registration rights, as described below.
Incidental Registration Rights. The Holders have the right to request the inclusion of their registrable shares in any registration statements filed by us in the future for the purposes of a public
offering, subject to specified exceptions. In the event that the managing underwriter advises that the number of shares proposed to be included in the offering exceeds the number that can be sold in such
offering without adversely affecting such underwriter’s ability to effect the distribution of such shares or that marketing factors require a limitation of the number of shares to be underwritten, the shares to
be included in the registration statement shall be allocated as follows: first, all shares sought to be registered by us for our own account, and second, all shares sought to be registered by the Holders, pro-
rata to the number of registrable shares owned by each selling Holder, or in such other proportions as shall mutually be agreed to by all such selling Holders.
In connection with the shelf registration statement on Form F-3 that we filed with the SEC on November 28, 2016 (File No. 333-214816), all Holders waived their rights to include any of their
registrable shares in the shelf registration statement.
Demand Registration. We may be required to effect up to two registrations on Form F-1 at the request of any of the Holders for all or any portion of their respective registrable shares, provided
that each such registration includes shares with an anticipated aggregate offering price of not less than $5.0 million (after deduction of underwriter discounts and commissions, share transfer taxes and
expenses of sale) (“Long-Form Registration”). We will not be required to effect any Long Form Registration requested within 180 days after the effective date of a previously effective registration of
securities. In addition, we will be able to delay effecting a Long Form Registration once in any 12-month period for a period not to exceed 90 consecutive days from the date of the request if we are
engaged or have plans to engage in a registered public offering or are engaged in any other activity which, in the good faith determination of our board of directors, would be adversely affected by the
requested registration.
Form F-3 Registration. We may be required to effect an unlimited number of registrations at the request of any of the Holders on Form F-3 of all or any portion of their respective registrable
shares provided that each such registration includes shares with an anticipated aggregate offering price of not less than $5.0 million (after deduction of underwriter discounts and commissions, share
transfer taxes and expenses of sale) (“Short-Form Registration” and together with a Long-Form Registration, a “Demand Registration”). We will not be required to effect any Short Form Registration
requested (i) within the nine month period after the effective date of a previously effective Short Form Registration, or (ii) during the period starting 60-days before our good faith estimate of the filing of
any registration statement pertaining to our securities and ending three months following our good faith estimate of the effective date of any such registration statement (subject to limited exceptions). In
addition, we will be able to delay the filing of a Form F-3 registration statement once in any 12-month period for a period not to exceed 90 consecutive days from the date of the request if, in the good
faith determination of our board of directors, it would not be in our best interest or in the best interest of our shareholders for such registration statement to be filed or effected at such time.
We will be required to give notice of a Demand Registration from any Holder to the other Holders that will be entitled to registration rights and include their shares in the registration if they so
request.
In the event that the managing underwriter advises that marketing factors require a limitation of the number of shares to be included in a Demand Registration, the shares to be included in the
registration statement shall be allocated as follows: first, all shares sought to be registered by the Holders, pro-rata to the number of registrable shares owned by each selling Holder, or in such other
proportions as shall mutually be agreed to by all such selling Holders, second, all shares sought to be registered by us for our own account, and third, any other shares sought to be registered.
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Termination. All registration rights granted to each Holder will terminate upon the earlier of (i) five years after our initial public offering in the United States (i.e., June 5, 2018) and (ii) as to any
Holder, such earlier time at which all registrable shares held by such Holder (and any affiliate of the Holder with whom such Holder must aggregate its sales under Rule 144) can be sold in any 90-day
period without registration under the Securities Act.
Expenses. We will pay all expenses in carrying out the above registrations, including the reasonable fees and expenses of one counsel for the initiating Holders, other than underwriter discounts
or commission with respect to Holders’ shares.
Brosh Letter Agreement
On November 9, 2017, we entered into a letter agreement with Brosh Capital Partners, L.P. and certain of its affiliates (collectively, “Brosh”) regarding, among other things, amending the agenda
for our 2017 annual general meeting of shareholders with respect to director nominees and board composition. Pursuant to the terms of the letter agreement, we agreed to amend the agenda for the 2017
annual general meeting to, among other things: (i) fix the size of our Board of Directors at ten members; (ii) add Mr. Asaf Frumerman, as a nominee for the election to the Board by the shareholders at the
meeting; and (iii) add two industry experts to be specified in a revised agenda for the meeting. Pursuant to the letter agreement, for as long as Mr. Frumerman (or his substitute) serves on our Board of
Directors, Brosh is prohibited from taking specified actions with respect to us and our securities, including, among others: (i) making or in any way participating in any solicitation of proxies to vote, or
seeking to advise, encourage or influence any person with respect to the voting of, any of our securities; (ii) subjecting any of our shares to any arrangement or agreement with respect to the voting
thereof, other than as set forth in the letter agreement; or (iii) seeking, alone or in concert with others, representation on our Board of Directors, except as provided for in the letter agreement. The
prohibitions in the immediately preceding sentence will remain in effect until we notify our shareholders that (i) we are convening a general meeting and (ii) the agenda of that general meeting includes
matters concerning the appointment or dismissal of members of the Board of Directors. For information regarding the holdings of the Brosh group, see “Item 7. Major Shareholders and Related Party
Transactions — Major Shareholders.|
Item 8. Financial Information
Consolidated financial statements are set forth under item 18.
Item 9. The Offer and Listing
Our ordinary shares are quoted on the Nasdaq Global Select Market and the TASE under the symbol “KMDA.”
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Nasdaq Global Market
The following table sets forth, for the periods indicated since May 30, 2013, which was the date on which our ordinary shares began trading on the Nasdaq Global Select Market, the high and low sales
prices of our ordinary shares as reported by the Nasdaq Global Select Market.
Annual:
2017
2016
2015
2014
2013 (from May 30, 2013)
Quarterly:
Fourth Quarter 2017
Third Quarter 2017
Second Quarter 2017
First Quarter 2017
Fourth Quarter 2016
Third Quarter 2016
Second Quarter 2016
First Quarter 2016
Most Recent Six Months:
February 2018 (through March 5, 2018)
January 2018
December 2017
November 2017
October 2017
September 2017
On March 5, 2018, the last reported sale price of our ordinary shares on the Nasdaq Global Select Market was $5.1 per share.
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Price Per Ordinary Share
Low
High
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
8.61
6.29
5.15
17.95
17.07
$
$
$
$
$
5.25
6.05
8.61
7.25
6.29
5.34
4.19
4.44
5.5
5.75
4.85
4.85
5.25
4.85
$
$
$
$
$
$
$
$
$
$
$
$
$
$
3.75
3.26
3.09
3.02
9.60
4.26
3.75
5.40
5.50
5.05
3.63
3.60
3.26
4.65
4.75
4.26
4.40
4.65
4.35
Tel Aviv Stock Exchange
The following table sets forth, for the periods indicated, the reported high and low sales prices of our ordinary shares on the TASE in NIS and U.S. dollars at a rate of $1.00 = NIS 3.456, the
exchange rate published by the Bank of Israel as March 5, 2018.
Annual:
2017
2016
2015
2014
2013
Quarterly:
Fourth Quarter 2017
Third Quarter 2017
Second Quarter 2017
First Quarter 2017
Fourth Quarter 2016
Third Quarter 2016
Second Quarter 2016
First Quarter 2016
Most Recent Six Months:
February 2018 (through March 5, 2018)
January 2018
December 2017
November 2017
October 2017
September 2017
NIS
Price Per Ordinary Share
Low
High
$
Price Per Ordinary Share
Low
High
29.20
23.25
19.45
62.00
60.77
18.40
21.30
29.20
27.10
23.25
19.79
16.05
17.70
18.97
19.67
16.55
17.69
18.40
17.20
14.81
13.10
12.09
11.60
33.80
15.25
14.81
19.05
20.89
19.27
14.05
14.01
13.10
16.45
16.40
15.25
15.50
16.48
15.85
8.45
6.32
4.97
15.85
15.54
5.32
6.16
8.45
7.84
6.32
5.38
4.36
4.81
5.49
5.69
4.79
5.12
5.32
4.98
4.29
3.56
3.09
2.97
8.64
4.41
4.29
5.51
6.04
5.24
3.82
3.81
3.56
4.76
4.75
4.41
4.48
4.77
4.59
On March 5, 2018, the last reported sale price of our ordinary shares on the TASE was NIS 17.69 per share, or $5.12 per share (based on the exchange rate reported by the Bank of Israel on such date,
which was NIS 3.456 = $1.00).
Item 10. Additional Information
A. Share Capital
Not applicable.
B. Memorandum and Articles of Association
Establishment and Purposes of the Company
We were incorporated under the laws of the State of Israel on December 13, 1990 under the name Kamada Ltd. We are registered with the Israeli Registrar of Companies in Jerusalem. Our
registration number is 51-152460-5. Our purpose as set forth in our amended articles of association is to engage in any lawful business.
Ordinary Shares
Voting
Holders of our ordinary shares have one vote per ordinary share on all matters submitted to a vote of shareholders at a shareholders’ meeting. Shareholders may vote at shareholder meetings
either in person, by proxy or, with respect to certain resolutions, by a voting instrument.
Israeli law does not allow public companies to adopt shareholder resolutions by means of written consent in lieu of a shareholder meeting.
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Transfer of Shares
Fully paid ordinary shares are issued in registered form and may be freely transferred under our articles of association unless the transfer is restricted or prohibited by another instrument, Israeli
law or the rules of a stock exchange on which the shares are traded.
Election of Directors
Our ordinary shares do not have cumulative voting rights for the election of directors. Rather, under our articles of association, directors (other than external directors, if any) are elected by the
holders of a simple majority of our ordinary shares at a general shareholder meeting (excluding abstentions). See “Item 6. Directors, Senior Management and Employees — Board of Directors.” As a
result, the holders of our ordinary shares that represent more than 50% of the voting power represented at a shareholder meeting and voting thereon (excluding abstentions) have the power to elect any or
all of our directors whose positions are being filled at that meeting (subject to the special approval requirements under the Israeli Companies Law for the election of external directors, if any). In addition,
under our articles of association, vacancies on our board of directors, including vacancies resulting from there being fewer than the maximum number of directors permitted by our articles of association,
may be filled by a vote of a simple majority of the directors then in office, and such appointment shall be valid until the next annual general meeting (or until such director ceases to serve in such capacity,
if earlier).
Dividend and Liquidation Rights
Under Israeli law, we may declare and pay dividends only if, upon the determination of our board of directors, there is no reasonable concern that the distribution will prevent us from being able
to meet the terms of our existing and foreseeable obligations as they become due. Under the Companies Law, the distribution amount is further limited to the greater of retained earnings or earnings
generated over the two most recent years legally available for distribution according to our then last reviewed or audited financial statements, after subtracting earlier distributions if they have not yet been
subtracted from the earnings, provided that the date of the financial statements is not more than six months prior to the date of distribution. In the event that we do not have retained earnings or earnings
generated over the two most recent years legally available for distribution, we may seek the approval of the court in order to distribute a dividend. The court may approve our request if it is convinced that
there is no reasonable concern that the payment of a dividend will prevent us from satisfying our existing and foreseeable obligations as they become due.
In the event of our liquidation, after satisfaction of liabilities to creditors, our assets will be distributed to the holders of ordinary shares in proportion to the nominal value of their shareholdings.
Dividend and liquidation rights may be affected by the grant of preferential dividend or distribution rights to the holders of a class of shares with preferential rights that may be authorized in the future
(subject to applicable law and applicable stock exchange rules).
Shareholder Meetings
Under the Companies Law, we are required to convene an annual general meeting of our shareholders at least once every calendar year and within a period of not more than 15 months following
the preceding annual general meeting. Our board of directors may convene a special general meeting of our shareholders whenever it sees fit and is required to do so upon the written request of two
directors or one quarter of the serving members of our board of directors, or one or more holders of 5% or more of our outstanding share capital and 1% of our voting power, or the holder or holders of 5%
or more of our voting power.
The Companies Law requires that resolutions regarding the following matters (among others) be approved by our shareholders at a general meeting: amendments to our articles of association;
appointment, terms of service and termination of service of our auditors; election of external directors; approval of certain related party transactions; increases or reductions of our authorized share capital;
mergers; and the exercise of our board of director’s powers by a general meeting, if our board of directors is unable to exercise its powers and the exercise of any of its powers is essential for our proper
management.
The chairman of our board of directors presides over our general meetings. However, if at any general meeting the chairman is not present within 15 minutes after the appointed time, or is
unwilling to act as chairman of such meeting, then the shareholders present will choose any other person present to be chairman of the meeting. Subject to the provisions of the Companies Law and the
regulations promulgated thereunder, shareholders entitled to participate and vote at general meetings are the shareholders of record on a date to be decided by the board of directors, which, as company
listed also on an exchange outside of Israel, may be between four and 40 days prior to the date of the meeting.
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Israeli law requires that a notice of any annual general meeting or special general meeting be provided to shareholders at least 21 days prior to the meeting and if the agenda of the meeting
includes, among other things, the appointment or removal of directors, the approval of transactions with office holders or interested or related parties, an approval of a merger or the approval of the
compensation policy, notice must be provided at least 35 days prior to the meeting.
Quorum
Pursuant to our articles of association, the quorum required for a meeting of our shareholders is the presence of two or more shareholders present in person, by proxy or by a voting instrument,
who hold at least 25% of our voting power. A meeting adjourned for lack of a quorum is generally adjourned to one week thereafter at the same time and place, or to such other day, time and place, as our
board of directors may indicate in the notice of the meeting to the shareholders. Pursuant to our articles of association, at the reconvened meeting, the meeting will take place with whatever number of
participants present.
Resolutions
Under the Companies Law, unless otherwise provided in our articles of association or applicable law, all resolutions of the shareholders require a simple majority of the voting rights represented
at the meeting, in person, by proxy or, with respect to certain resolutions, by a voting instrument, and voting on the resolution (excluding abstentions). Under Israeli law, a resolution for the voluntary
winding up of the company requires the approval by the holders of 75% of the voting rights represented at the meeting, in person or by proxy and voting on the resolution (excluding abstentions). Under
our articles of association, a merger shall require the approval of a special majority of the shareholders, as described below under “Merger.”
Access to Corporate Records
Under the Companies Law, all shareholders generally have the right to review minutes of our general meetings, our shareholder register and register of significant shareholders (as defined in the
Companies Law), our articles of association, our financial statements and any document we are required by law to file publicly with the Israeli Companies Registrar or with the Israel Securities Authority.
In addition, any shareholder who specifies the purpose of its request may request to review any document in our possession that relates to: (i) any action or transaction with a related party which requires
shareholder approval under the Companies Law; or (ii) the approval, by the board of directors, of an action in which an office holder has a personal interest. We may deny a request to review a document
if we determine that the request was not made in good faith, that the document contains a commercial or technological secret or that the document’s disclosure may otherwise impair our interests.
Acquisitions Under Israeli Law
Full Tender Offer
A person wishing to acquire shares of an Israeli public company and who would, as a result, hold over 90% of the target company’s issued and outstanding share capital (or over 90% of the
issued and outstanding share capital of a certain class of shares) is required by the Companies Law to make a tender offer to all of the company’s shareholders (or all of the shareholders who hold shares of
the same class) for the purchase of all of the issued and outstanding shares of the company or of a certain class. If the shareholders who do not respond to or accept the offer hold less than 5% of the issued
and outstanding share capital of the company or of the applicable class of the shares, and more than half of the shareholders who do not have a personal interest in the offer accept the offer, all of the
shares that the acquirer offered to purchase will be transferred to the acquirer by operation of law. However, a tender offer will also be accepted if the shareholders who do not accept it hold less than 2%
of the issued and outstanding share capital of the company or of the applicable class of the shares.
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Upon a successful completion of such a full tender offer, any shareholder that was an offeree in such tender offer, whether such shareholder accepted the tender offer or not, may, within six
months from the date of acceptance of the tender offer, petition an Israeli court to determine whether the tender offer was for less than fair value and that the fair value should be paid as determined by the
court. However, under certain conditions, the offeror may include in the terms of the tender offer that an offeree who accepted the offer will not be entitled to petition the Israeli court as described above.
If (a) the shareholders who did not respond or accept the tender offer hold at least 5% of the issued and outstanding share capital of the company or of the applicable class or the shareholders who
accept the offer constitute less than a majority of the offerees that do not have a personal interest in the acceptance of the tender offer, or (b) the shareholders who did not accept the tender offer hold 2% or
more of the issued and outstanding share capital of the company (or of the applicable class), the acquirer may not acquire shares of the company that will increase its holdings to more than 90% of the
company’s issued and outstanding share capital or of the applicable class from shareholders who accepted the tender offer.
Special Tender Offer
The Companies Law provides that an acquisition of shares of an Israeli public company must be made by means of a special tender offer if as a result of the acquisition the purchaser would
become a holder of 25% or more of the voting rights in the company. This rule does not apply if there is already another holder of 25% or more of the voting rights in the company.
Similarly, the Companies Law provides that an acquisition of shares in a public company must be made by means of a special tender offer if as a result of the acquisition the purchaser would
become a holder of more than 45% of the voting rights in the company, provided there is no other shareholder of the company who holds more than 45% of the voting rights in the company.
These requirements do not apply if the acquisition (i) occurs in the context of a private placement, that was approved by the company’s shareholders and whose purpose is to give the acquirer at
least 25% of the voting rights in the company if there is no person who holds 25% or more of the voting rights in the company, or as a private placement whose purpose is to give the acquirer 45% of the
voting rights in the company, if there is no person who holds 45% of the voting rights in the company; (ii) was from a shareholder holding 25% or more of the voting rights in the company and resulted in
the acquirer becoming a holder of 25% or more of the voting rights in the company; or (iii) was from a holder of more than 45% of the voting rights in the company and resulted in the acquirer becoming
a holder of more than 45% of the voting rights in the company.
A special tender offer must be extended to all shareholders of a company. The special tender offer may be consummated only if (i) at least 5% of the voting power attached to the company’s
outstanding shares will be acquired by the offeror, and (ii) the number of shares tendered in the offer exceeds the number of shares whose holders objected to the offer (excluding controlling shareholders,
holders of 25% or more of the voting rights in the company and any person having a personal interest in the acceptance of the tender offer).
In the event that a special tender offer is made, a company’s board of directors is required to express its opinion on the advisability of the offer or it may abstain from expressing any opinion if it
is unable to do so, provided that it gives the reasons for its abstention.
An office holder in a target company who, in his or her capacity as an office holder, performs an action the purpose of which is to cause the failure of an existing or foreseeable special tender
offer or is to impair the chances of its acceptance, is liable to the potential purchaser and shareholders for damages resulting from his acts, unless such office holder acted in good faith and had reasonable
grounds to believe he or she was acting for the benefit of the company. However, office holders of the target company may negotiate with the potential purchaser in order to improve the terms of the
special tender offer, and may further negotiate with third parties in order to obtain a competing offer.
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If a special tender offer is accepted, then shareholders who did not respond to the special offer or had objected to the special tender offer may accept the offer within four days of the last day set
for the acceptance of the offer.
In the event that a special tender offer is accepted, then the purchaser or any person or entity controlling it and any corporation controlled by them must refrain from making a subsequent tender
offer for the purchase of shares of the target company and may not effect a merger with the target company for a period of one year from the date of the offer, unless the purchaser or such person or entity
undertook to effect such an offer or merger in the initial special tender offer.
Merger
The Companies Law permits merger transactions if approved by each party’s board of directors and, unless certain requirements described under the Companies Law are met, a majority of each
party’s shareholders. Under our articles of association, a merger shall require the approval of 66.6% of the voting rights represented at a meeting of our shareholders and voting on the matter, in person or
by proxy, and any amendment to such provision shall require the approval of 60% of the voting rights represented at a meeting of our shareholders and voting on the matter, in person or by proxy.
The board of directors of a merging company is required pursuant to the Companies Law to discuss and determine whether in its opinion there exists a reasonable concern that as a result of a
proposed merger, the surviving company will not be able to satisfy its obligations towards its creditors, taking into account the financial condition of the merging companies. If the board of directors has
determined that such a concern exists, it may not approve a proposed merger. Following the approval of the board of directors of each of the merging companies, the boards of directors must jointly
prepare a merger proposal for submission to the Israeli Registrar of Companies.
For purposes of the shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if a majority of the shares voting at the shareholders meeting (excluding abstentions)
that are held by parties other than the other party to the merger, any person who holds 25% or more of the outstanding shares or the right to appoint 25% or more of the directors of the other party, or any
one on their behalf including their relatives or corporations controlled by any of them, vote against the merger.
In addition, if the non-surviving entity of the merger has more than one class of shares, the merger must be approved by each class of shareholders.
If the transaction would have been approved but for the separate approval of each class of shares or the exclusion of the votes of certain shareholders as provided above, a court may still rule that
the company has approved the merger upon the request of holders of at least 25% of the voting rights of a company, if the court holds that the merger is fair and reasonable, taking into account the
appraisal of the merging companies’ value and the consideration offered to the shareholders.
Under the Companies Law, a merging company must send a copy of the proposed merger plan to its secured creditors no later than three days after the date on which the merger proposal was
submitted to the Israeli Companies Registrar. Unsecured creditors are entitled to receive notice of the merger, as provided by the regulations promulgated under the Companies Law. Upon the request of a
creditor of a merging company, the court may delay or prevent the merger if it concludes that there exists a reasonable concern that, as a result of the merger, the surviving company will be unable to
satisfy the obligations of the target company. The court may also give instructions in order to secure the rights of creditors.
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In addition, a merger may not be completed unless at least 50 days have passed from the date that a proposal for approval of the merger was filed with the Israeli Registrar of Companies and 30
days from the date that shareholder approval of both merging companies was obtained.
Anti-takeover Measures
The Companies Law allows us to create and issue shares having rights different from those attached to our ordinary shares, including shares providing certain preferred or additional rights to
voting, distributions or other matters and shares having preemptive rights. We do not have any authorized or issued shares other than ordinary shares. In the future, if we do create and issue a class of
shares other than ordinary shares, such class of shares, depending on the specific rights that may be attached to them, may delay or prevent a takeover or otherwise prevent our shareholders from realizing
a potential premium over the market value of their ordinary shares. The authorization of a new class of shares will require an amendment to our articles of association which requires the prior approval of
a majority of our shares represented and voting at a general meeting. Shareholders voting at such a meeting will be subject to the restrictions under the Companies Law described above in “— Ordinary
Shares — Voting.” Pursuant to the Israeli Securities Law, 5728-1968, a company whose shares are traded on the TASE may not have more than one class of shares except for preferred shares which may
have a dividend preference but may not have any voting rights.
Tax Law
Israeli tax law treats some acquisitions, such as stock-for-stock swaps between an Israeli company and a foreign company, less favorably than U.S. tax law. For example, Israeli tax law may
subject a shareholder who exchanges ordinary shares in an Israeli company for shares in a non-Israeli corporation to immediate taxation unless such shareholder receives authorization from the Israeli Tax
Authority for different tax treatment.
Modification of Class Rights
The Companies Law and our articles of association provide that the rights of a particular class of shares may not be modified without the affirmative vote at a separate meeting of such class of a
majority of shares actually participating in such class meeting.
Transfer Agent and Registrar
The transfer agent and registrar for our ordinary shares is American Stock Transfer & Trust Company, LLC. The nominee company to the TASE in whose name most of our outstanding shares
are held of record is Mizrahi Tefahot Registration Company Ltd.
C. Material Contracts
We have not entered into any material contracts other than in the ordinary course of business and other than those described in “Item 4. Information on the Company” or elsewhere in this Annual
Report.
D. Exchange Controls
Non-residents of Israel who hold our ordinary shares are able to receive any dividends, and any amounts payable upon the dissolution, liquidation and winding up of our affairs, freely repatriable
in non-Israeli currency at the rate of exchange prevailing at the time of conversion. However, Israeli income tax is required to have been paid or withheld on these amounts. In addition, the statutory
framework for the potential imposition of exchange controls has not been eliminated, and may be restored at any time by administrative action.
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E. Taxation
The following description is not intended to constitute a complete analysis of all tax consequences relating to the acquisition, ownership and disposition of our ordinary shares. You should consult
your own tax advisor concerning the tax consequences of your particular situation, as well as any tax consequences that may arise under the laws of any state, local, foreign or other taxing jurisdiction.
Israeli Tax Considerations and Government Programs
The following is a brief summary of the material Israeli tax laws applicable to us, and certain Israeli Government programs benefiting us. This section also contains a discussion of material Israeli
tax consequences concerning the ownership of and disposition of our ordinary shares. This summary does not discuss all aspects of Israeli tax law that may be relevant to a particular investor in light of
his or her personal investment circumstances or to some types of investors, such as traders in securities, who are subject to special treatment under Israeli law. The discussion below is subject to
amendment under Israeli law or changes to the applicable judicial or administrative interpretations of Israeli law, which could affect the tax consequences described below.
The discussion below does not cover all possible tax considerations. Potential investors are urged to consult their own tax advisors as to the Israeli or other tax consequences of the purchase,
ownership and disposition of our ordinary shares, including in particular, the effect of any foreign, state or local taxes.
General Corporate Tax Structure in Israel
Israeli companies are generally subject to corporate tax, which has decreased in recent years, from a rate of 26.5% in 2014 and 2015 to 25% in 2016 and to 24% in 2017, and further decreased to
23% in 2018. However, the effective corporate tax rate payable by a company that derives income from an Approved Enterprise, a Privileged Enterprise or a Preferred Enterprise (as discussed below) may
be considerably less. Capital gains generated by an Israeli company are generally subject to tax at the corporate tax rate.
Law for the Encouragement of Industry (Taxes), 1969
The Law for the Encouragement of Industry (Taxes), 1969 (the “Encouragement of Industry Law”), provides several tax benefits to “Industrial Companies.” Pursuant to the Encouragement of
Industry Law, a company qualifies as an Industrial Company if it is a resident of Israel and at least 90% of its income in any tax year (exclusive of income from certain defense loans) is generated from an
“Industrial Enterprise” that it owns. An Industrial Enterprise is defined as an enterprise whose principal activity, in a given tax year, is industrial activity.
An Industrial Company is entitled to certain tax benefits, including: (i) a deduction of the cost of purchases of patents and know-how and the right to use patents and know-how used for the
development or promotion of the Industrial Enterprise in equal amounts over a period of eight years, beginning from the year in which such rights were first used, (ii) the right to elect to file consolidated
tax returns, under certain conditions, with additional Israeli Industrial Companies controlled by it, and (iii) the right to deduct expenses related to public offerings in equal amounts over a period of three
years beginning from the year of the offering.
Eligibility for benefits under the Encouragement of Industry Law is not contingent upon the approval of any governmental authority.
There is no assurance that we qualify or will continue to qualify as an Industrial Company or that the benefits described above will be available in the future.
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Law for the Encouragement of Capital Investments, 1959
Our facilities in Israel have been granted Approved Enterprise status under the Law for the Encouragement of Capital Investments, 1959, commonly referred to as the “Investment Law”. The
Investment Law provides that a capital investment in eligible production facilities (or other eligible assets) may, upon application to the Investment Center, be designated as an “Approved Enterprise.”
Each certificate of approval for an Approved Enterprise relates to a specific investment program delineated both by its financial scope, including its sources of capital, and by its physical characteristics,
for example, the equipment to be purchased and utilized pursuant to the program. The tax benefits generated from any such certificate of approval relate only to taxable income attributable to the specific
Approved Enterprise.
In recent years the Investment Law has undergone major reforms and several amendments which were intended to provide expanded tax benefits and to simplify the bureaucratic process relating
to the approval of investments qualifying under the Investment Law. The different benefits under the Investment Law depend on the specific year in which the enterprise received approval from the
Investment Center or the year it was eligible for Approved/Privileged Enterprise status under the Investment Law, and the benefits available at that time. Below is a short description of the different
benefits available to us under the Investment Law:
Approved Enterprise
One of our facilities was granted Approved Enterprise status by the Investment Center, which made us eligible for a grant and certain tax benefits under the “Grant Track.” The approved
investment program provided us with a grant in the amount of 24% of our approved investments, in addition to certain tax benefits, which will apply to our turnover resulting from the operation of such
investment program, for a period of up to ten consecutive years from the first year in which we generated taxable income. The tax benefits under the Grant Track include accelerated depreciation and
amortization for tax purposes as well as a tax exemption for the first two years of the benefit period and the taxation of income generated from an Approved Enterprise at a reduced corporate tax rate of
10%-25%, for a certain period of time. The benefit period is ordinarily seven to ten years commencing with the year in which the Approved Enterprise first generates taxable income. The benefit period is
limited to 12 years from the earlier of the operational year as determined by the Investment Center or 14 years from the date of approval of the Approved Enterprise. We have not used all the tax benefits
under the Approved Enterprise status, yet.
Privileged Enterprise
We obtained a tax ruling from the Israeli Tax Authority according to which, among other things, our activity has been qualified as an “industrial activity”, as defined in the Investment Law and is
also eligible to tax benefits as a Privileged Enterprise under the “Tax Benefit Track,” which will apply to the turnover attributed to such enterprise, for a period of up to ten years from the first year in
which we generated taxable income.
On April 1, 2005, an amendment to the Investment Law came into effect (the “2005 Amendment”), which revised the criteria for investments qualified to receive tax benefits. An eligible
investment program under the 2005 Amendment will qualify for benefits as a “Privileged Enterprise” (rather than the previous terminology of Approved Enterprise). Pursuant to the 2005 Amendment, a
company whose facilities meet certain criteria set forth in the 2005 Amendment may claim certain tax benefits offered by the Investment Law (as further described below) directly in its tax returns,
without the need to obtain prior approval. In order to receive the tax benefits, the company must make an investment in the Privileged Enterprise which meets all of the conditions, including exceeding a
certain percentage or a minimum amount, specified in the Investment Law. Such investment must be made over a period of no more than three years ending at the end of the year in which the company
requested to have the tax benefits apply to the Privileged Enterprise (the “Year of Election”). According to the tax ruling mentioned above, our Year of Election is 2009. We also elected 2012 as a Year of
Election. The duration of tax benefits is subject to a limitation of the earlier of seven to ten years from the first year in which the company generated taxable income (at or after the Year of Election), or 12
years from the first day of the Year of Election. Therefore, the tax benefits under our Privileged Enterprise are scheduled to expire at the end of 2020 and 2023.
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The term “Privileged Enterprise” means an industrial enterprise which is “competitive” and contributes to the gross domestic product, and for which a minimum entitling investment was made in
order to establish it (as explained above). For this purpose, an industrial enterprise is deemed to be competitive and contributing to the gross domestic product if it meets one of the following conditions:
(1) its main activity is in the field of biotechnology or nanotechnology, as certified by the Director of the Industrial Research and Development Administration before the project was approved; or (2) its
income during a tax year from sales to a certain market does not exceed 75% of its total income from sales in that tax year; or (3) 25% or more of its total income from sales in the tax year is from sales to
a certain market with at least 14,000,000 inhabitants.
A taxpayer owning a Privileged Enterprise is entitled to a reduced corporate tax rate for income from the sale of products produced by the Privileged Enterprise in each tax year during the benefit
period. In addition, the Privileged Enterprise is entitled to claim accelerated depreciation for manufacturing assets used by the Privileged Enterprise.
The tax benefits available to Privileged Enterprises under the “Tax Benefits Track” are as follows: An exemption from corporate tax may be available on undistributed income for a period of two
to ten years, depending on the location of the Privileged Enterprise within Israel, as well as a reduced corporate tax rate of 10% to 25% for the remainder of the benefit period, depending on the level of
foreign investment in each year.
However, a company that pays a dividend out of income generated during the tax exemption period from the Privileged/Approved Enterprise is subject to deferred corporate tax with respect to
the otherwise exempt income (grossed-up to reflect the pre-tax income that we would have had to earn in order to distribute the dividend) at the corporate tax rate which would have applied if the
company had not enjoyed the exemption (i.e. at a reduced tax rate between 10% and 25%, depending on the level of foreign investment). A company is generally required to withhold tax on such
distribution at a rate of 20% effective as of January 1, 2014 (or a reduced rate under an applicable double tax treaty, subject to the approval by the Israeli Tax Authority).
Preferred Enterprise
An amendment to the Investment Law that became effective on January 1, 2011 (“Amendment No. 68”) changed the benefit alternatives available to companies under the Investment Law and
introduced new benefits to “Preferred Enterprises.” The tax benefits granted to a Preferred Enterprise are determined depending on the location of the Preferred Enterprise within Israel. Amendment No.
68 imposes a reduced flat corporate tax rate which is not program-dependent and applies to the industrial enterprise’s entire “preferred income” which is generated by its Preferred Enterprise.
According to the Investment Law, a uniform corporate tax rate will apply to all qualifying income of the Preferred Enterprise. Under an amendment to the Investment Law that became effective
on January 1, 2014, the uniform corporate tax rate was 9% in areas in Israel designated as Development Zone A and 16% elsewhere in Israel, effective as of January 1, 2014. Under an amendment to the
Investment Law that became effective on January 1, 2017, the uniform corporate tax rate in areas in Israel designated as Development Zone A was reduced to 7.5%.
The tax benefits under Amendment No. 68 also include accelerated depreciation and amortization for tax purposes during the first five-year period for productive assets that the Preferred
Enterprise uses pursuant to the rates prescribed in the Investment Law. Preferred Enterprises located in specific locations within Israel (Zone A) are eligible for grants and/or loans approved by the Israeli
Investment Center, as well as tax benefits. Our facility in Beit-Kama, Israel, is located in zone A.
A dividend distributed from income which is attributed to a Preferred Enterprise/Special Preferred Enterprise will be subject to withholding tax at source at the following rates: (i) Israeli resident
corporation – 0%, (ii) Israeli resident individual – 20% as of 2014 (iii) non-Israeli resident – 20% as of 2014 subject to a reduced tax rate under the provisions of an applicable double tax treaty.
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The provisions of Amendment No. 68 do not apply to existing Privileged Enterprises or Approved Enterprises, which will continue to be entitled to the tax benefits under the Investment Law as
in effect prior to Amendment No. 68. Nevertheless, a company owning such enterprises may choose to apply Amendment No. 68 to its existing enterprises while waiving benefits provided under the
Investment Law as in effect prior to Amendment No. 68. A company owning a Privileged Enterprise or an Approved Enterprise that made such election by July 30, 2015, is entitled to distribute income
generated by the Approved/Privileged Enterprise to its Israeli corporate shareholders tax free. Once a company elects to be classified as a Preferred Enterprise under the provisions of Amendment No. 68,
the election cannot be rescinded and such company will no longer enjoy the tax benefits of its Approved/Privileged Enterprises.
To date, we have not elected to be classified as a Preferred Enterprise under Amendment No. 68.
There can be no assurance that we will comply with the conditions required to remain eligible for benefits under the Investment Law in the future, including under our certificate of approval with
respect to our Approved Enterprise and our tax ruling with respect to our Privileged Enterprise, or that we will be entitled to any additional benefits thereunder. If we do not fulfill these conditions in
whole or in part, the benefits can be canceled and we may be required to refund the amount of the benefits, linked to the Israeli consumer price index, with interest.
The Encouragement of Industrial Research, Development and Technological Innovation in the Industry Law, 5744-1984 (formerly known as The Encouragement of Industrial Research and
Development Law, 5744-1984)
We have received grants from the Government of the State of Israel through the Israel Innovation Authority of the Israeli Ministry of Economy and Industry (the “IIA”) (formerly known as the
Office of the Chief Scientist of the Israeli Ministry of Economy (the “OCS”)), for the financing of a portion of our research and development expenditures pursuant to the Encouragement of Research,
Development and Technological Innovation in the Industry Law 5744-1984 (formerly known as the Encouragement of Industrial and Development Law, 5744-1984) (the “Research Law”) and related
regulations. We previously received funding from the IIA for five research and development programs, in the aggregate amount of approximately $1.7 million as of December 31, 2017, which amount has
accrued aggregate interest of approximately $8,252 as of such date, and we had paid aggregate royalties to the IIA for these programs in the amount of approximately $1 million and had a contingent
liability to the IIA in the amount of approximately $0.7 million (excluding any interest thereon) as of December 31, 2017.
Under the Research Law, research and development programs which meet specified criteria and are approved by the IIA (formerly the OCS) are eligible for grants. Under the Research Law, as
currently in effect, the grants awarded are typically up to 50% of the project’s expenditures. The grantee is required to pay royalties to the State of Israel from the sale of products developed under the
program. Regulations under the Research Law, as currently in effect, generally provide for the payment of royalties of 3% to 5% on sales of products and services based on technology developed using
grants, until 100% (which may be increased under certain circumstances) of the U.S. dollar-linked value of the grant is repaid, with interest at the rate of 12-month LIBOR. The terms of the Israeli
government participation also require that products developed with government grants be manufactured in Israel and that the technology developed thereunder may not be transferred outside of Israel,
unless approval is received from the IIA and additional payments are made to the State of Israel. However, this does not restrict the export of products that incorporate the funded technology. The royalty
repayment ceiling can reach up to three times the amount of the grant received if manufacturing is moved outside of Israel, and if the funded technology itself is transferred outside of Israel, the royalty
ceiling can reach up to six times the amount of grants (plus interest). Even following the full repayment of any IIA grants, we must nevertheless continue to comply with the requirements of the Research
Law. If we fail to comply with any of the conditions and restrictions imposed by the Research Law, or by the specific terms under which we received the grants, we may be required to refund any grants
previously received together with interest and penalties, and, in certain circumstances, may be subject to criminal charges.
A significant amendment to the Research Law entered into effect on January 1, 2016, under which the IIA, a statutory government corporation, was established, which replaced the OCS. Under
such amendment, the IIA is authorized to establish rules concerning the ownership and exploitation of IIA-funded know-how (including with respect to restrictions on transfer of manufacturing activities
and IIA-funded know-how outside of Israel), which may differ from the restrictive laws, regulations and guidelines in effect prior to the establishment of such rules (and which remain in effect until such
rules have been established by the IIA). In May 2017, the IIA issued new rules applicable to Israeli companies that receive grants from the IIA or its predecessor, the OCS, which went into effect on July
1, 2017. Among other things, the new rules establish a framework for funded companies to license IIA-funded know how to companies outside of Israel without necessarily triggering an exit payment (as
described above). As of the date hereof, we cannot predict the impact these new rules will have on us or how they will be implemented by the IIA. Furthermore, it is anticipated that additional rules will
be published by the IIA and we cannot predict or estimate the changes (if any) that may be made to this legislation (including with respect to the acquisition of a IIA-funded entity or the transfer of an IIA
-funded technology).
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Taxation of Our Shareholders
This discussion does not address the tax consequences applicable to shareholders that own, or have owned at any time, directly or indirectly, 10% or more of our shares (“Controlling
Shareholders”), and such shareholders should consult their tax advisers as to the tax consequences of owning or disposing of our shares.
Capital gains
Under present Israeli tax legislation, the tax rate applicable to real capital gain derived by Israeli resident corporations from the sale of shares of an Israeli company is the general corporate tax
rate (which was 26.5% in 2014 and 2015, reduced to 25% in 2016 and 24% in 2017 and reduced to 23% in 2018).
Generally, as of January 1, 2006, the tax rate applicable to real capital gain derived by Israeli individuals from the sale of shares which had been purchased on or after January 1, 2003, whether or
not listed on a stock exchange, is 25%, unless such shareholder claims a deduction for interest and linkage differences expenses in connection with the purchase and holding of such shares. Additionally,
if such a shareholder is considered a “Substantial Shareholder” (i.e., a person who holds, directly or indirectly, alone or together with another, 10% or more of any of the company’s “means of control”
(including, among other things, the right to receive profits of the company, voting rights, the right to receive the company’s liquidation proceeds and the right to appoint a director)) at the time of sale or at
any time during the preceding 12-month period, such gain will be taxed at the rate of 30%. Individual shareholders dealing in securities in Israel are taxed at their marginal tax rates applicable to business
income (up to 48% in the years 2014-2016 and 47% from 2017).
Furthermore, an additional tax liability at the rate of 2% in the years 2014-2016 and 3% in 2017 onwards is added to the applicable tax rate on the annual taxable income of individuals (whether
any such individual is an Israeli resident or non-Israeli resident) exceeding NIS 810,720 in 2015, NIS 803,520 in 2016 and NIS 640,000 in 2017 onwards.
Notwithstanding the foregoing, capital gains generated from the sale of shares by a non-Israeli shareholder may be exempt from Israeli taxes provided that, in general, both the following
conditions are met: (i) the seller of the shares does not have a permanent establishment in Israel to which the generated capital gain is attributed and (ii) if the seller is a corporation, less than 25% of its
means of control are held, directly and indirectly, by Israeli residents or Israeli residents that are the beneficiaries or are eligible to less than 25% of the seller’s income or profits from the sale. In addition,
the sale of the shares may be exempt from Israeli capital gain tax under the provisions of an applicable tax treaty. For example, the Convention between the Government of the United States of America
and the Government of Israel with respect to Taxes on Income, or the “Israel-U.S.A. Double Tax Treaty,” generally exempts U.S. residents from Israeli capital gains tax in connection with such sale,
provided that (i) the U.S. resident owned, directly or indirectly, less than 10% of the Israeli resident company’s voting power at any time within the 12-month period preceding such sale; (ii) the seller, if
an individual, has been present in Israel for less than 183 days (in the aggregate) during the taxable year; and (iii) the capital gain from the sale was not generated through a permanent establishment of the
U.S. resident in Israel.
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The purchaser of the shares, the stockbrokers who effected the transaction or the financial institution holding the shares through which payment to the seller is made are obligated, subject to the
above-referenced exemptions if certain conditions are met, to withhold tax on the Real Capital Gain resulting from a sale of shares at the rate of 25%.
A detailed return, including a computation of the tax due, must be filed and an advance payment must be paid on January 31 and July 31 of each tax year for sales of shares traded on a stock
exchange made within the six months preceding the month of the report. However, if the seller is exempt from tax or all tax due was withheld at the source according to applicable provisions of the Israeli
Income Tax Ordinance and the regulations promulgated thereunder, the return does not need to be filed and an advance payment does not need to be made. Taxable capital gains are also reportable on an
annual income tax return if applicable.
Dividends
Our company is obligated to withhold tax, at the rate of 20% effective as of January 1, 2014, upon the distribution of a dividend attributed to an Approved/Privileged Enterprise’s income, subject
to a reduced tax rate under the provisions of an applicable double tax treaty, provided that a certificate from the Israeli Tax Authorities allowing for a reduced withholding tax rate is obtained in advance. If
the dividend is distributed from income not attributed to an Approved/Privileged Enterprise, the following withholding tax rates will apply: (i) Israeli resident corporations — 0%, (ii) Israeli resident
individuals — 25% (or 30% in the case of a Substantial Shareholder) and (iii) non-Israeli residents (whether an individual or a corporation) — 25%, subject to a reduced tax rate under the provisions of an
applicable double tax treaty, provided that a certificate from the Israeli Tax Authorities allowing for a reduced withholding tax rate is obtained in advance. Generally, the withholding rate will not be
reduced under the Israel-U.S.A. Double Tax Treaty.
Estate and gift tax
Israeli law presently does not impose estate or gift taxes.
United States Federal Income Taxation
The following is a description of the material U.S. federal income tax consequences to a U.S. Holder (as defined below) of the acquisition, ownership and disposition of our ordinary shares. This
description addresses only the U.S. federal income tax consequences to holders of our ordinary shares in the United States that will hold our ordinary shares as capital assets for U.S. federal income tax
purposes. This description does not address many of the tax considerations applicable to holders that may be subject to special tax rules, including, without limitation:
·
·
·
·
·
·
·
banks, certain financial institutions or insurance companies;
real estate investment trusts, regulated investment companies or grantor trusts;
dealers or traders in securities, commodities or currencies;
tax-exempt entities;
certain former citizens or long-term residents of the United States;
persons that received our shares as compensation for the performance of services;
persons that will hold our shares as part of a “hedging,” “integrated” or “conversion” transaction or as a position in a “straddle” for U.S. federal income tax purposes;
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·
·
·
·
·
partnerships (including entities classified as partnerships for U.S. federal income tax purposes) or other pass-through entities, or holders that will hold our shares through such an entity;
S-corporations;
persons whose “functional currency” is not the U.S. Dollar;
persons that own directly, indirectly or through attribution 10% or more of the voting power or value of our shares; or
persons holding our ordinary shares in connection with a trade or business conducted outside the United States.
Moreover, this description does not address the U.S. federal estate, gift or alternative minimum tax consequences, or any state, local or foreign tax consequences, of the acquisition, ownership
and disposition of our ordinary shares.
This description is based on the U.S. Internal Revenue Code of 1986, as amended, (the “Code”), existing, proposed and temporary U.S. Treasury Regulations and judicial and administrative
interpretations thereof, in each case as in effect on the date hereof. All of the foregoing is subject to change, which change could apply retroactively and could affect the tax consequences described below.
There can be no assurance that the U.S. Internal Revenue Service (“IRS”) will not take a different position concerning the tax consequences of the acquisition, ownership and disposition of our ordinary
shares or that the IRS’s position would not be sustained.
For purposes of this description, a “U.S. Holder” is a beneficial owner of our ordinary shares that, for U.S. federal income tax purposes, is:
·
·
·
a citizen or resident of the United States;
a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized in or under the laws of the United States or any jurisdiction thereof; or
a trust or estate the income of which is subject to United States federal income taxation regardless of its source.
Holders should consult their tax advisors with respect to the U.S. federal, state, local and foreign tax consequences of acquiring, owning and disposing of our ordinary shares.
Distributions
Subject to the discussion below under “Passive Foreign Investment Company Considerations,” the gross amount of any distribution made to a U.S. Holder with respect to our ordinary shares
before reduction for any Israeli taxes withheld therefrom, other than certain pro rata distributions of our ordinary shares to all our shareholders, generally will be includible in the U.S. Holder’s income as
dividend income to the extent the distribution is paid out of our current or accumulated earnings and profits as determined under U.S. federal income tax principles. Subject to the discussion below under
“Passive Foreign Investment Company Considerations,” non-corporate U.S. Holders may qualify for the lower rates of taxation with respect to dividends on ordinary shares applicable to long-term capital
gains (i.e., gains from the sale of capital assets held for more than one year) provided that certain conditions are met, including certain holding period requirements and the absence of certain risk
reduction transactions. However, dividends on our ordinary shares will not be eligible for the dividends received deduction generally allowed to corporate U.S. Holders. Subject to the discussion below
under “Passive Foreign Investment Company Considerations,” to the extent that the amount of any distribution by us exceeds our current and accumulated earnings and profits as determined under U.S.
federal income tax principles, it will be treated first as a tax-free return of tax basis in our ordinary shares and thereafter as capital gain. We do not expect to maintain calculations of our earnings and
profits under U.S. federal income tax principles and, therefore, U.S. Holders should expect that the entire amount of any distribution generally will be reported as dividend income.
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Dividends paid to U.S. Holders with respect to our ordinary shares will be treated as foreign source income, which may be relevant in calculating a U.S. Holder’s foreign tax credit limitation.
Subject to certain conditions and limitations, Israeli tax withheld on dividends may be deducted from taxable income or credited against U.S. federal income tax liability. An election to deduct foreign
taxes instead of claiming foreign tax credits applies to all foreign taxes paid or accrued in the taxable year. The limitation on foreign taxes eligible for credit is calculated separately with respect to specific
classes of income. For this purpose, dividends that we distribute generally should constitute “passive category income,” or, in the case of certain U.S. Holders, “general category income.” A foreign tax
credit for foreign taxes imposed on distributions may be denied if certain minimum holding period requirements are not satisfied. The rules relating to the determination of the foreign tax credit are
complex, and U.S. Holders should consult their tax advisors to determine whether and to what extent they will be entitled to this credit.
Sale, Exchange or Other Disposition of Ordinary Shares
Subject to the discussion below under “Passive Foreign Investment Company Considerations,” U.S. Holders generally will recognize gain or loss on the sale, exchange or other disposition of our
ordinary shares equal to the difference between the amount realized on the sale, exchange or other disposition and the holder’s tax basis in our ordinary shares, and any gain or loss will be capital gain or
loss. The tax basis in an ordinary share generally will be equal to the cost of the ordinary share. For non-corporate U.S. Holders, capital gain from the sale, exchange or other disposition of ordinary shares
is generally eligible for a preferential rate of taxation in the case of long-term capital gain. The deductibility of capital losses for U.S. federal income tax purposes is subject to limitations under the Code.
Any gain or loss that a U.S. Holder recognizes generally will be treated as U.S. source income or loss for foreign tax credit limitation purposes.
Passive Foreign Investment Company Considerations
If we were to be classified as a “passive foreign investment company” (“PFIC”) in any taxable year, a U.S. Holder would be subject to special rules generally intended to reduce or eliminate any
benefits from the deferral of U.S. federal income tax that a U.S. Holder could derive from investing in a non-U.S. company that does not distribute all of its earnings on a current basis.
A non-U.S. corporation will be classified as a PFIC for U.S. federal income tax purposes in any taxable year in which, after applying certain look-through rules, either
·
·
at least 75% of its gross income is “passive income”, or
at least 50% of the average quarterly value of its gross assets is attributable to assets that produce passive income or are held for the production of passive income.
Passive income for this purpose generally includes dividends, interest, royalties, rents, gains from commodities and securities transactions, the excess of gains over losses from the disposition of
assets which produce passive income and amounts derived by reason of the temporary investment of funds raised in offerings of our ordinary shares. If a non-U.S. corporation owns at least 25% by value
of the stock of another corporation, the non-U.S. corporation is treated for purposes of the PFIC tests as owning its proportionate share of the assets of the other corporation and as directly receiving its
proportionate share of the other corporation’s income. If we are classified as a PFIC in any year with respect to which a U.S. Holder owns our ordinary shares, we generally will continue to be treated as a
PFIC with respect to that U.S. Holder in all succeeding years during which the U.S. Holder owns our ordinary shares, regardless of whether we continue to meet the tests described above.
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However, our PFIC status for each taxable year may be determined only after the end of such year and will depend on the composition of our income and assets, our activities and the value of our
assets (which may be determined in large part by reference to the market value of our ordinary shares, which may be volatile) from time to time. If we are a PFIC then unless a U.S. Holder makes one of
the elections described below, a special tax regime will apply to both (i) any “excess distribution” by us to that U.S. Holder (generally, the U.S. Holder’s ratable portion of distributions in any year which
are greater than 125% of the average annual distribution received by the holder in the shorter of the three preceding years or its holding period for our ordinary shares) and (ii) any gain realized on the sale
or other disposition of the ordinary shares.
Under this regime, any excess distribution and realized gain will be treated as ordinary income and will be subject to tax as if (i) the excess distribution or gain had been realized ratably over the
U.S. Holder’s holding period, (ii) the amount deemed realized in each year had been subject to tax in each year of that holding period at the highest marginal rate for that year (other than income allocated
to the current period or any taxable period before we became a PFIC, which will be subject to tax at the U.S. Holder’s regular ordinary income rate for the current year and will not be subject to the
interest charge discussed below), and (iii) the interest charge generally applicable to underpayments of tax had been imposed on the taxes deemed to have been payable in those years. In addition, dividend
distributions made to a U.S. Holder will not qualify for the lower rates of taxation applicable to long-term capital gains discussed above under “Distributions.” Certain elections may be available that
would result in an alternative treatment (such as mark-to-market treatment) of our ordinary shares. We do not intend to provide the information necessary for U.S. Holders to make qualified electing fund
elections if we are classified as a PFIC. U.S. Holders should consult their tax advisors to determine whether any of these elections would be available and if so, what the consequences of the alternative
treatments would be in their particular circumstances.
If we are determined to be a PFIC, the general tax treatment for U.S. Holders described in this paragraph would apply to indirect distributions and gains deemed to be realized by U.S. Holders in
respect of any of our subsidiaries that also may be determined to be PFICs.
In addition, all U.S. Holders may be required to file tax returns (including on IRS Form 8621) containing such information as the U.S. Treasury may require. For example, if a U.S. Holder owns
ordinary shares during any year in which we are classified as a PFIC and the U.S. Holder recognizes gain on a disposition of our ordinary shares or receives distributions with respect to our ordinary
shares, the U.S. Holder generally will be required to file an IRS Form 8621 with respect to the company, generally with the U.S. Holder’s federal income tax return for that year. The failure to file this
form when required could result in substantial penalties.
Based on the financial information currently available to us and the nature of our business, we do not expect that we will be classified as a PFIC for the taxable year ending December 31, 2017.
However, this determination could be subject to change. If, contrary to our expectations, we were to be classified as a PFIC, U.S. Holders of ordinary shares may be required to file form 8621 with respect
to their ownership of our ordinary shares in the year in which we were a PFIC. U.S. Holders of our ordinary shares should consult their tax advisors in this regard.
Backup Withholding and Information Reporting Requirements
U.S. backup withholding and information reporting requirements may apply to payments to holders of our ordinary shares. Information reporting generally will apply to payments of dividends
on, and to proceeds from the sale of, our ordinary shares made within the United States, or by a U.S. payor or U.S. middleman, to a holder of our ordinary shares, other than an exempt recipient (including
a corporation). A payor may be required to backup withhold from payments of dividends on, or the proceeds from the sale or redemption of, ordinary shares within the United States, or by a U.S. payor or
U.S. middleman, to a holder, other than an exempt recipient, if the holder fails to furnish its correct taxpayer identification number or otherwise fails to comply with, or establish an exemption from, the
backup withholding tax requirements. Any amounts withheld under the backup withholding rules generally should be allowed as a credit against the beneficial owner’s U.S. federal income tax liability, if
any, and any excess amounts withheld under the backup withholding rules may be refunded, provided that the required information is timely furnished to the IRS.
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Additional Medicare Tax
Certain U.S. Holders who are individuals, estates or trusts may be required to pay an additional 3.8% Medicare tax on, among other things, dividends and capital gains from the sale or other
disposition of shares of common stock. For individuals, the additional Medicare tax applies to the lesser of (i) “net investment income” or (ii) the excess of “modified adjusted gross income” over
$200,000 ($250,000 if married and filing jointly or $125,000 if married and filing separately). “Net investment income” generally equals the taxpayer’s gross investment income reduced by the deductions
that are allocable to such income. U.S. Holders will likely not be able to credit foreign taxes against the 3.8% Medicare tax.
Foreign Asset Reporting
Certain U.S. Holders who are individuals (and certain domestic entities) may be required to report information relating to an interest in our ordinary shares, subject to certain exceptions
(including an exception for shares held in accounts maintained by U.S. financial institutions). U.S. Holders are urged to consult their tax advisors regarding their information reporting obligations, if any,
with respect to their ownership and disposition of our ordinary shares.
The above description is not intended to constitute a complete analysis of all tax consequences relating to acquisition, ownership and disposition of our ordinary shares. Holders should
consult their tax advisors concerning the tax consequences of their particular situations.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
H. Documents on Display
You may inspect our securities filings, including this Annual Report and the exhibits and schedules thereto, without charge at the offices of the SEC at 100 F Street, N.E., Washington, D.C.
20549. You may obtain copies of all or any part of the Annual Report from the Public Reference Section of the SEC, 100 F Street, NE, Washington, D.C. 20549 upon the payment of the prescribed fees.
You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC maintains a website at www.sec.gov that contains reports, proxy and
information statements and other information regarding registrants like us that file electronically with the SEC. You can also inspect the Annual Report on this website.
A copy of each document (or a translation thereof to the extent not in English) concerning our company that is referred to in this Annual Report is available for public view (subject to
confidential treatment of certain agreements pursuant to applicable law) at our principal executive offices.
I. Subsidiary Information
Not applicable.
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Item 11. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
We are exposed to changes in interest arising from our financial assets as our financial debt bears fixed interest rates. We invest our cash balance in interest-bearing deposits. We have exposure to
investments in deposits or securities bearing fixed interest, which expose us to interest rate risk with respect to fair value.
Foreign Currency Risk
Fluctuations in exchange rates, especially the NIS against the U.S. dollar, may affect our results, as part of our assets is linked to NIS, as are part of our liabilities. Changes in exchange rates may
also affect the prices of products purchased by us and designated for marketing in Israel in cases where these product prices are not linked to the U.S. dollar and during the period after these products are
sold to our customers in NIS. In addition, the fluctuation in the NIS exchange rate against the U.S. dollar may impact our results, as a portion of our manufacturing cost is NIS denominated.
For the years ended December 31, 2017, 2016 and 2015, we have witnessed high volatility in the U.S. dollar exchange rate. This fact impacts our revenues from the Distribution segment, where
prices are denominated in or linked to the NIS upon delivery of product while our expenses for the purchase of raw materials and imported goods in the Distribution segment are in U.S. dollars and part of
our development and marketing expenses are paid in NIS.
We attempt to mitigate our currency exposure by matching assets denominated in NIS currency with liabilities denominated in NIS. In the Distribution segment, we attempt to mitigate foreign
currency exposure by matching Euro denominated expenses with Euro denominated revenues. Additionally, we used, and from time to time, will continue to use, currency hedging transactions using
financial derivatives and forward currency contracts. We attempt to enter into forward currency contracts with critical terms that match those of the underlying exposure. As of December 31, 2017, we had
open transactions in derivatives in the amount of approximately $16.6 million. We regularly monitor and review the need for currency hedging transactions in accordance with trend analysis.
The following table presents information about the changes in the exchange rates of the NIS against the U.S. dollar:
Period
Year ended December 31, 2015
Year ended December 31, 2016
Year ended December 31, 2017
Change in Average
Exchange Rate of
the NIS against the
U.S. Dollar (%)
8.6
(1.2)
(6.3)
As of December 31, 2017, we had excess liabilities over assets denominated in NIS in the amount of $2.9 million. When the U.S. dollar appreciates against the NIS, we recognize financial
expenses with respect to exchange rate differences. When the U.S. dollar devalues against the NIS, we recognize financial revenues.
As of December 31, 2017, we had foreign currency exposures to currencies other than U.S. dollars amounting to $2.7 million in excess liabilities over assets. Most of this exposure is to the Euro.
A 10% increase (decrease) in the value of the NIS against the U.S. dollar would have decreased (increased) our financial assets by1.3 $ million, $1.3 million and $0.6 million as of December 31,
2017, 2016 and 2015, respectively.
Item 12. Description of Securities Other Than Equity Securities
Not applicable.
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PART II
Item 13. Defaults, Dividend Arrearages and Delinquencies
Not applicable.
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds
Initial Public Offering
On June 5, 2013, we completed an initial public offering in the United States on Nasdaq of our ordinary shares, par value NIS 1.00 per share, pursuant to a Registration Statement on Form F-1, as
amended (File No. 333-187870), which became effective on May 30, 2013. Morgan Stanley & Co. LLC and Jefferies LLC acted as representatives of the underwriters. We registered 5,582,636 ordinary
shares in the offering and granted the underwriters a 30-day over-allotment option to purchase up to 837,395 additional ordinary shares from us. The option to purchase additional ordinary shares was
exercised in full on June 4, 2013.
Pursuant to the initial public offering, we sold a total of 6,420,031 ordinary shares (including the shares sold pursuant to the over-allotment option) at a price of $9.25 per share. The aggregate
offering price of the shares sold (including the over-allotment option) was approximately $59.4 million. The total expenses of the offering, including underwriting discounts and commissions, were
approximately $6.6 million. The net proceeds we received from the offering (including the over-allotment option) were approximately $52.8 million. We paid a one-time management compensation
payment associated with the initial public offering of approximately $1.1 million.
As of December 31, 2017, we have used a large portion of the net proceeds of our initial public offering. We intend to use the remaining net proceeds we received from our initial public offering
as disclosed in our Registration Statement on Form F-1.
Item 15. Controls and Procedures
(a) Disclosure Controls and Procedures. Our management, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the
effectiveness of our disclosure controls and procedures as of December 31, 2017, pursuant to Rule 13a-15 under the Exchange Act. Based on that evaluation, our Chief Executive Officer and our Chief
Financial Officer (the principal executive and principal financial officer, respectively) have concluded that our disclosure controls and procedure are effective to provide reasonable assurance that
information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and
principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure, and is recorded, processed, summarized and reported, within the
time periods specified in the SEC’s rules and forms.
(b) Report of Management on Internal Control over Financial Reporting. Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our
management has assessed the effectiveness of internal control over financial reporting based on the Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations
of the Treadway Commission (COSO). Based on this assessment, our management has concluded that our internal control over financial reporting as of December 31, 2017 was effective.
(c) Attestation Report of the Registered Public Accounting Firm. This annual report does not include an attestation report of the company’s registered public accounting firm because we qualify
as an emerging growth company and, as such, are exempt from such attestation.
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(d) Changes in Internal Control over Financial Reporting. During the period covered by this report, we have not made any changes to our internal control over financial reporting that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 16A. Audit committee financial expert
Our board of directors has determined that Avraham Berger is an “independent” director for purposes of serving on an audit committee under the Exchange Act and Nasdaq listing requirements
and qualifies as an “audit committee financial expert,” as defined in Item 407(d)(5) of Regulation S-K.
Item 16B. Code of Ethics
In November 2011, we adopted a Code of Ethics, which applies to our directors, officers and employees, including our Chief Executive Officer and Chief Financial Officer, principal accounting
officer or controller, and persons performing similar functions. The Code of Ethics is posted on our website, www.kamada.com.
Item 16C. Principal Accountant Fees and Services
During the years ended December 31, 2017 and 2016, we were billed the following aggregate fees for the professional services rendered by Kost Forer Gabbay and Kasierer, a member of Ernst
& Young Global, independent registered public accounting firm:
Year Ended December 31,
2016
2017
Audit Fees(1)
Audit-Related Fees(2)
Tax Fees and others(3)
Total
___________
(1) Audit fees are aggregate fees for audit services for each of the years shown in this table, including fees associated with the annual audit and reviews of our quarterly financial results submitted on
190,000 $
110,000
8,000
308,000 $
190,000
15,000
33,615
238,615
$
$
Form 6-K, consultations on various accounting issues and audit services provided in connection with other statutory or regulatory filings.
(2) Audit-related fees in 2016 are for services rendered by our auditors in connection with our shelf registration statement on Form F-3. Audit-related fees in 2017 are for services rendered by our
auditors in connection with the registration statement and prospectus supplement.
(3) Tax services in 2016 rendered by our auditors were for tax compliance and for tax consulting associated with international transfer pricing. Tax services in 2017 rendered by our auditors were for
equity incentive awards and other services for methodology support in the area of business continuity.
Our audit committee has adopted a policy for pre-approval of audit and non-audit services provided by our independent auditor. Under the policy, such services must require the specific pre-
approval of our audit committee followed by ratification of our full board of directors. Any proposed services exceeding the pre-approval amounts for all services to be provided by our independent
auditor require an additional specific pre-approval by our audit committee.
Item 16D. Exemptions from the Listing Standards for Audit Committees
Not applicable.
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Item 16E. Purchase of Equity Securities by the Issuer and Affiliated Purchasers
In the year ended December 31, 2017, neither the company nor any affiliated purchaser (as defined in the Exchange Act) purchased any of the company’s ordinary shares.
Item 16F. Change in Registrant's Certifying Accountant
None.
Item 16G. Corporate Governance
As a foreign private issuer whose shares are listed on the Nasdaq Global Select Market, we have the option to follow Israeli corporate governance practices rather than certain of those of Nasdaq,
except to the extent that such laws would be contrary to U.S. securities laws and provided that we disclose the practices we are not following and describe the home country practices we follow instead.
We rely on this “foreign private issuer exemption” with respect to the following Nasdaq requirements:
·
·
·
·
Shareholder approval requirements for equity issuances and equity-based compensation plans. Under the Companies Law, the adoption of, and material changes to, equity-based
compensation plans generally require the approval of the board of directors (for approval of equity based arrangements, see “Item 6. Directors, Senior Management and Employees —
Fiduciary Duties and Approval of Specified Related Party Transactions under Israeli Law — Disclosure of Personal Interests of a Controlling Shareholder and Approval of Certain
Transactions,” “Item 6. Directors, Senior Management and Employees — Compensation of Directors” and “Item 6. Directors, Senior Management and Employees — Compensation of
Executive Officers”). Similarly, the approval of the board of directors is generally sufficient for a private placement unless the private placement is deemed a “significant private placement”
(see “Item 6. Directors, Senior Management and Employees — Approval of Significant Private Placements”), in which case shareholder approval is also required, or an office holder or a
controlling shareholder or their relative has a personal interest in the private placement, in which case, audit committee approval is required prior to the board approval and, for a private
placement in which a controlling shareholder or its relative has a personal interest, shareholder approval is also required (see “Item 6. Directors, Senior Management and Employees —
Fiduciary Duties and Approval of Specified Related Party Transactions under Israeli Law”).
Requirement for independent oversight on our director nominations process and to adopt a formal written charter or board resolution addressing the nominations process. In accordance
with Israeli law and practice, directors are recommended by our board of directors for election by our shareholders. The Damar Group and Recananti Group have entered into a shareholders’
agreement which includes an agreement about voting in the election of nominees appointed by the other party (see “Item 7. Major Shareholders and Related Party Transactions — Related
Party Transactions — Shareholders’ Agreement”).
Quorum requirement. Under our articles of association and as permitted under the Companies Law, a quorum for any meeting of shareholders shall be the presence of at least two
shareholders present in person, by proxy or by a voting instrument, who hold at least 25% of the voting power of our shares instead of 33 1/3% of the issued share capital required under
Nasdaq requirements. At an adjourned meeting, any number of shareholders shall constitute a quorum.
Compensation Committee Charter. As permitted under the Companies Law, we do not have a formal charter for our compensation committee.
150
·
Except as stated above, we comply with the rules generally applicable to U.S. domestic companies listed on Nasdaq subject to certain exemptions the JOBS Act provides to emerging growth
companies. We may in the future decide to use other foreign private issuer exemptions with respect to some or all of the other Nasdaq listing requirements. Following our home country
governance practices, as opposed to the requirements that would otherwise apply to a company listed on Nasdaq, may provide less protection than is accorded to investors under Nasdaq
listing requirements applicable to domestic issuers. For more information, see “Item 3. Key Information —D. Risk Factors — We are an ‘emerging growth company’ with reduced reporting
requirements that may make our ordinary shares less attractive to investors” and “Item 3. Key Information —D. Risk Factors — As we are a ‘foreign private issuer’ and intend to follow
certain home country corporate governance practices, our shareholders may not have the same protections afforded to shareholders of companies that are subject to all Nasdaq corporate
governance requirements.” We are also required to comply with Israeli corporate governance requirements under the Companies Law applicable to Israeli public companies, such as us,
whose shares are also listed for trade on an exchange outside Israel.
Item 16H. Mine Safety Disclosure
Not applicable.
151
Item 17. Financial Statements
Consolidated Financial Statements are set forth under Item 18.
Item 18. Financial Statements
PART III
Our Consolidated Financial Statements beginning on pages F-1 through F-56, as set forth in the following index, are hereby incorporated herein by reference. These Consolidated Financial
Statements are filed as part of this Annual Report.
Report of Independent Registered Public Accounting Firm
Consolidated Financial Statements as of December 31, 2017:
Consolidated Balance Sheets
Consolidated Statements of Comprehensive Income (Loss)
Consolidated Statements of Changes in Equity
Consolidated Statements of Cash Flows
Notes to the Consolidated Financial Statements
Page
F-2
F-3
F-4
F-5
F-6
F-8
Item 19. Exhibits
Exhibit No.
1.1
1.2
2.1
4.1†
4.2†
4.3†
4.4†
Description
Amended Articles of Association of the Registrant (incorporated by reference to Appendix A2 to the Proxy Statement for the 2016 Annual General Meeting of Shareholders, filed
as Exhibit 99.1 to Form 6-K filed with the Securities and Exchange Commission on July 26, 2016).
Memorandum of Association of the Registrant, as currently in effect (as translated from Hebrew) (incorporated by reference to Exhibit 3.1 of the Registration Statement on Form F-
1 filed with the Securities and Exchange Commission on May 15, 2013).
Form of Certificate for Ordinary Shares (incorporated by reference to Exhibit 4.1 of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on
May 15, 2013).
Exclusive Manufacturing, Supply and Distribution Agreement, dated as of August 23, 2010, by and between Kamada Ltd. and Baxter Healthcare Corporation (incorporated by
reference to Exhibit 10.1 of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on May 15, 2013).
Technology License Agreement, dated as of August 23, 2010, by and between Kamada Ltd. and Baxter Healthcare S.A. (incorporated by reference to Exhibit 10.2 of the
Registration Statement on Form F-1 filed with the Securities and Exchange Commission on May 15, 2013).
Amended and Restated Fraction IV-1 Paste Supply Agreement, dated as of August 23, 2010, by and between Kamada Ltd. and Baxter Healthcare Corporation (incorporated by
reference to Exhibit 10.3 of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on April 11, 2013).
First Amendment to the Amended and Restated Fraction IV-1 Paste Supply Agreement, dated as of May 10, 2011, by and between Kamada Ltd. and Baxter Healthcare Corporation
(incorporated by reference to Exhibit 10.4 of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on April 11, 2013).
152
4.5†
4.6†
4.7†
4.8†
4.9†
4.10†
4.11
4.12
4.13
4.14†
4.15
4.16
4.17
4.18†
4.19†
Second Amendment to the Amended and Restated Fraction IV-1 Paste Supply Agreement, dated as of June 22, 2011, by and between Kamada Ltd. and Baxter Healthcare
Corporation (incorporated by reference to Exhibit 10.5 of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on April 11, 2013).
License Agreement, dated as of November 16, 2006, by and between PARI GmbH and Kamada Ltd. (incorporated by reference to Exhibit 10.7 of the Registration Statement on
Form F-1 filed with the Securities and Exchange Commission on April 11, 2013).
Amendment No. 1 to License Agreement, dated as of August 9, 2007, by and between PARI GmbH and Kamada Ltd. (incorporated by reference to Exhibit 10.8 of the Registration
Statement on Form F-1 filed with the Securities and Exchange Commission on April 11, 2013).
Addendum No. 1 to License Agreement, dated as of February 21, 2008, by and between PARI GmbH and Kamada Ltd. (incorporated by reference to Exhibit 10.9 of the
Registration Statement on Form F-1 filed with the Securities and Exchange Commission on April 11, 2013).
Supply and Distribution Agreement, dated as of July 18, 2011, by and between Kamada Ltd. and Kedrion S.p.A. (incorporated by reference to Exhibit 10.10 of the Registration
Statement on Form F-1 filed with the Securities and Exchange Commission on April 11, 2013).
Distribution Agreement, dated as of August 2, 2011, by and between Kamada Ltd. and TUTEUR S.A.C.I.F.I.A. (incorporated by reference to Exhibit 10.11 of the Registration
Statement on Form F-1 filed with the Securities and Exchange Commission on April 11, 2013).
English translation of form of Indemnification Agreement with the Registrant’s directors and officers (incorporated by reference to Exhibit 10.15 of the Registration Statement on
Form F-1 filed with the Securities and Exchange Commission on May 15, 2013).
English translation of amendment to form of Indemnification Agreement with the Registrant’s directors and officers (incorporated by reference to Appendixes A3 and A4 of the
Proxy filed as Exhibit 99.1 to Form 6-K filed with the Securities and Exchange Commission on May 22, 2015).
English summary of two lease agreements dated June 20, 2002, by and between the Israel Lands Administration and Kamada Nehasim (2001) Ltd., as such agreements were
amended by lease agreement dated January 30, 2011, by and between the Israel Lands Administration and Kamada Nehasim (2001) Ltd. (incorporated by reference to Exhibit 10.16
of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on April 11, 2013).
Fraction IV-1 Paste Supply Agreement, dated December 3, 2012, by and between Baxter Healthcare S.A. and Kamada Ltd. (incorporated by reference to Exhibit 10.18 of the
Registration Statement on Form F-1 filed with the Securities and Exchange Commission on April 11, 2013).
Registration Rights Agreement, dated as of April 14, 2013, by and among Kamada Ltd. and the individuals and entities identified therein (incorporated by reference to Exhibit 10.19
of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on May 15, 2013).
Side Letter Agreement, dated as of March 23, 2011, by and between Kamada Ltd. and Baxter Healthcare Corporation (incorporated by reference to Exhibit 10.20 of the Registration
Statement on Form F-1 filed with the Securities and Exchange Commission on May 15, 2013).
First Amendment to the Exclusive Manufacturing Supply and Distribution Agreement, dated as of September 6, 2012, between Kamada Ltd. and Baxter Healthcare Corporation
(incorporated by reference to Exhibit 10.21 of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on May 15, 2013).
Second Amendment to the Exclusive Manufacturing, Supply and Distribution Agreement, dated as of May 14, 2013, by and between Kamada Ltd. and Baxter Healthcare
Corporation (incorporated by reference to Exhibit 10.22 of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on May 15, 2013).
First Amendment to the Technology License Agreement, dated as of May 14, 2013, by and between Kamada Ltd. and Baxter Healthcare Corporation (incorporated by reference to
Exhibit 10.23 of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on May 28, 2013).
153
4.20†
4.21†
4.22†
4.23†
4.24†
4.25†
4.26
4.27
4.28†
4.29
8.1
12.1
12.2
13.1
15.1
________
Third Amendment to the Exclusive Manufacturing, Supply and Distribution Agreement, dated as of September 2014, by and between Kamada Ltd. and Baxter Healthcare
Corporation (incorporated by reference to Exhibit 4.25 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 28, 2015).
First Amendment to the Distribution Agreement dated as of August 19, 2014, by and between Kamada Ltd. and TUTEUR S.A.C.I.F.I.A (incorporated by reference to Exhibit 4.26
of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 28, 2015).
Third Amendment to the Amended and Restated Fraction IV-1 Paste Supply Agreement executed on June 19, 2015 by and between Kamada Ltd. and Baxalta US Inc. (incorporated
by reference to Exhibit 4.29 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2016).
Fourth Amendment to the Exclusive Manufacturing, Supply and Distribution Agreement, dated as of October, 2015, by and between Kamada Ltd. and Baxalta US Inc.
(incorporated by reference to Exhibit 4.30 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2016).
Second Amendment to the Technology License Agreement, dated as of August 25, 2015, by and between Kamada Ltd. and Baxalta GmbH. (incorporated by reference to Exhibit
4.31 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on February 25, 2016).
Fifth Amendment to the Exclusive Manufacturing, Supply and Distribution Agreement, dated as of October 5, 2016, by and between Kamada Ltd. and Shire plc. (incorporated by
reference to Exhibit 4.28 of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 1, 2017)
Compensation Policy, approved by the shareholders of the Registrant on November 30, 2017 (incorporated by reference to Exhibit 99.2 to Form 6-K filed with the Securities and
Exchange Commission on November 30, 2017).
Kamada Ltd. 2011 Israeli Share Award Plan (incorporated by reference to Exhibit 4.2 to the Form S-8 filed with the Securities and Exchange Commission on February 9, 2017).
1st Addendum to Supply And Distribution Agreement dated October 15, 2016 between Kamada Ltd., and Kedrion S.p.A. (incorporated by reference to Exhibit 4.32 of the Annual
Report on Form 20-F filed with the Securities and Exchange Commission on March 1, 2017).
Termination Agreement dated as of November 14, 2017 by and between Kamada Ltd. and Chiesi Farmaceutici S.p.A.
Subsidiaries of the Registrant.
Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a).
Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a).
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
Consent of Ernst & Young Global, independent registered public accounting firm.
†
Portions of this exhibit have been omitted pursuant to a request for confidential treatment and the non-public information has been filed separately with the Securities and Exchange Commission.
154
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
SIGNATURES
Date: March 5, 2018
KAMADA LTD.
By:
/s/ Chaime Orlev
Chaime Orlev
Chief Financial Officer
155
Kamada Ltd.
Consolidated Financial Statements as of December 31, 2017
Table of Contents
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Profit or Loss and Other Comprehensive Income (Loss)
Consolidated Statements of Changes in Equity
Consolidated Statements of Cash Flows
Notes to the Consolidated Financial Statements
Kamada Ltd. and its subsidiaries
Page
F - 2
F - 3
F - 4
F - 5
F - 6 - F - 7
F - 8 - F - 56
Kamada Ltd. and its subsidiaries
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of KAMADA LTD.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Kamada Ltd (the "Company") as of December 31, 2017 and 2016, and the related consolidated statements of profit or Loss and
other comprehensive income, shareholders' equity and cash flows for each of the three years in the period ended December 31, 2017, and the related notes (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidation financial statements present fairly, in all material respects, the consolidated financial position of the Company at December 31, 2017 and 2016, and
the results of its operations and its cash flows for each of the three years in the period ended December 31, 2017, in conformity with International Financial Reporting Standards as issued by the
International Accounting Standards Board.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a
public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the
U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those
risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used
and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ KOST FORER GABBAY & KASIERER
KOST FORER GABBAY & KASIERER
A Member of Ernst & Young Global
We have served as the Company‘s auditor since 2005.
Tel-Aviv, Israel
March 6, 2018
F - 2
Consolidated Balance Sheets
Current Assets
Cash and cash equivalents
Short-term investments
Trade receivables, net
Other accounts receivables
Inventories
Property, plant and equipment, net
Other long term assets
Current Liabilities
Current maturities of loans and capital leases
Trade payables
Other accounts payables
Deferred revenues
Non-Current Liabilities
Loans and capital leases
Employee benefit liabilities, net
Deferred revenues
Shareholders' Equity
Ordinary shares
Additional paid in capital
Capital reserve due to translation to presentation currency
Capital reserve from hedges
Capital reserve from available for sale financial assets
Capital reserve from share-based payments
Capital reserve from employee benefits
Accumulated deficit
The accompanying notes are an integral part of the Consolidated Financial Statements.
F - 3
$
Note
5
6
7
8
9
10
11
14
12
13
17a,b
14
16
17a,b
19
Kamada Ltd. and its subsidiaries
As of December 31,
2017
2016
In thousands
$
12,681
30,338
30,662
2,132
21,070
96,883
25,178
49
25,227
122,110
614
18,036
5,820
4,927
29,397
1,370
1,144
707
3,221
10,400
177,874
(3,490)
46
(4)
9,566
(337)
(104,563)
89,492
9,968
18,664
19,788
3,063
25,594
77,077
22,579
40
22,619
99,696
412
16,277
5,614
4,903
27,206
1,364
722
3,661
5,747
9,320
162,671
(3,490)
(27)
19
9,795
(81)
(111,464)
66,743
$
122,110
$
99,696
Consolidated Statements of Profit or Loss and Other Comprehensive Income (Loss)
Revenues from proprietary products
Revenues from distribution
Total revenues
Cost of revenues from proprietary products
Cost of revenues from distribution
Total cost of revenues
Gross profit
Research and development expenses
Selling and marketing expenses
General and administrative expenses
Operating income (loss)
Financial income
Income (expense) in respect of currency exchange differences and derivatives instruments, net
Financial expense
Gain (loss) before taxes on income
Taxes on income
Net income (loss)
Other Comprehensive Income (loss):
Items that may be reclassified to profit or loss in subsequent periods:
Gain (loss) on available for sale financial assets
Gain (loss) on cash flow hedges
Net amounts transferred to the statement of profit or loss for cash flow hedges
Items that will not be reclassified to profit or loss in subsequent periods:
Actuarial gain (loss) from defined benefit plans
Total comprehensive income (loss)
Income (loss) per share attributable to equity holders of the Company:
23
Basic income (loss) per share
Diluted income (loss) per share
The accompanying notes are an integral part of the Consolidated Financial Statements.
F - 4
22b
22c
22d
22e
22f
22f
Kamada Ltd. and its subsidiaries
Note
In thousands, except for share and per share data
2017
2016
2015
For the Year Ended
December 31,
$
$
79,559
23,266
22a
102,825
$
55,958
21,536
77,494
37,723
18,411
56,134
21,360
16,245
3,243
7,353
(5,481)
469
127
(126)
(5,011)
1,722
(6,733)
(54)
47
(73)
42,952
26,954
69,906
30,901
23,640
54,541
15,365
16,530
3,652
6,607
(11,424)
463
625
(934)
(11,270)
-
(11,270)
63
71
44
(22)
(6,835)
$
22
(11,070)
51,335
19,402
70,737
32,088
11,973
4,398
8,273
7,444
500
(612)
(162)
7,170
269
6,901
(23)
329
(256)
(256)
6,695
$
$
$
$
0.18 $
0.18
$
(0.18)
(0.18)
$
$
(0.31)
(0.31)
Consolidated Statements of Changes in Equity
Kamada Ltd. and its subsidiaries
Share
capital
Additional
paid in
capital
Conversion
option in
convertible
debentures
Capital
reserve
from
Available
for sale
financial
assets
Capital
reserve due
to
translation
to
presentation
currency
Capital
reserve
from
share-
based
payments
Capital
reserve
from
employee
benefits
Capital
reserve
from
hedges
Balance as of December 31, 2014
Net loss
Other comprehensive income
Total comprehensive income (loss)
Exercise of options into shares
Expiration of conversion option on
convertible debentures
Cost of share-based payment
Balance as of December 31, 2015
Net loss
Other comprehensive loss
Total comprehensive loss
Exercise of options into shares
Cost of share-based payment
Balance as of December 31, 2016
Net income
Other comprehensive income (loss)
Total comprehensive income (loss)
Exercise and forfeiture of share-based
payment into shares
Issuance of ordinary shares, net of
issuance costs
Cost of share-based payment
Balance as of December 31, 2017
* Represent an amount lower than $1.
$
$
$
$
$
$
$
$
$
$
9,208
-
-
-
112
-
-
9,320
-
-
--
*
-
9,320
-
-
-
158,417
-
-
-
2,674
1,147
-
162,238
-
-
--
433
-
162,671
-
-
-
3
712
1,077
-
10,400
$
14,491
-
177,874
$
1,147
-
-
-
-
(1,147)
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
$
$
$
$
The accompanying notes are an integral part of the Consolidated Financial Statements
10
-
63
63
-
-
-
73
-
(54)
(54)
-
-
19
-
(23)
(23)
-
-
-
(4)
$
$
$
$
F - 5
$
In thousands
(3,490)
-
-
-
-
(116)
-
115
115
-
$
$
-
-
(3,490)
-
-
-
-
-
(3,490)
-
-
-
-
-
-
(3,490)
$
-
-
(1)
-
(26)
(26)
-
-
(27)
-
73
73
-
-
-
46
$
$
$
$
8,783
-
-
-
(1,533)
-
1,907
9,157
-
-
-
(433)
1,071
9,795
-
-
-
(712)
-
483
9,566
$
$
$
$
(81)
-
22
22
-
-
-
(59)
-
(22)
(22)
-
-
(81)
-
(256)
(256)
-
-
-
(337)
Accumulated
deficit
Total
equity
$
$
$
$
$
$
(93,461)
(11,270)
-
(11,270)
-
-
-
(104,731)
(6,733)
-
(6,733)
-
-
(111,464)
6,901
-
6,901
80,417
(11,270)
200
(11,070)
1,253
-
1,907
72,507
(6,733)
(102)
(6,835)
*
1,071
66,743
6,901
(206)
6,695
-
3
-
-
(104,563)
$
15,568
483
89,492
$
Consolidated Statements of Cash Flows
Cash Flows from Operating Activities
Net income (loss)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Adjustments to the profit or loss items:
Depreciation and impairment
Financial expenses (income), net
Cost of share-based payment
Income tax expense
Gain from sale of property and equipment
Change in employee benefit liabilities, net
Changes in asset and liability items:
Decrease (increase) in trade receivables, net
Decrease in other accounts receivables
Decrease (increase) in inventories
Decrease (increase) in deferred expenses
Increase (decrease) in trade payables
Increase in other accounts payables
Increase (decrease) in deferred revenues
Cash received (paid) during the year for:
Interest paid
Interest received
Taxes paid
Note
10,11
20
Kamada Ltd. and its subsidiaries
2017
For the Year Ended December 31,
2016
In thousands
2015
$
6,901
$
(6,733)
$
(11,270)
3,523
274
483
269
(52)
166
4,663
(9,967)
328
4,524
594
(838)
71
(2,930)
(8,218)
(21)
399
(116)
262
3,501
(470)
1,071
1,722
(18)
(87)
5,719
3,489
211
742
(433)
(2,650)
1,520
1,035
3,914
(60)
842
(1,785)
(1,003)
3,227
(154)
1,907
-
-
87
5,067
(5,604)
118
(913)
(565)
887
94
(2,405)
(8,388)
(484)
1,143
(47)
612
Net cash provided by (used in) operating activities
$
3,608
$
1,897
$
(13,979)
The accompanying notes are an integral part of the Consolidated Financial Statements.
F - 6
Consolidated Statements of Cash Flows
Cash Flows from Investing Activities
Proceeds from sale of )investment in) short term investments, net
Purchase of property and equipment and intangible assets
Proceeds from sale of property and equipment
Net cash provided by (used in) investing activities
Cash Flows from Financing Activities
Proceeds from exercise of warrants and options
Receipt of long-term loans
Repayment of long-term loans
Repayment of convertible debentures
Proceeds from issuance of ordinary shares, net
Net cash provided by (used in) financing activities
Exchange differences on balances of cash and cash equivalent
Increase (decrease) in cash and cash equivalents
Cash and cash equivalents at the beginning of the year
Cash and cash equivalents at the end of the year
Significant non-cash transactions
Purchase of property and equipment through capital lease
Purchase of property and equipment
*Represent an amount of less than 1 thousands
The accompanying notes are an integral part of the Consolidated Financial Statements.
F - 7
Note
10
Kamada Ltd. and its subsidiaries
2017
For the Year Ended
December 31,
2016
In thousands
2015
$
(11,501)
(4,167)
60
(15,608)
$
4,236
(2,641)
42
1,637
3
279
(530)
-
15,568
15,320
(607)
2,713
9,968
*
1,701
(211)
-
-
1,490
(103)
4,921
5,047
13,971
(2,718)
-
11,253
1,254
197
(9)
(7,797)
-
(6,355)
(418)
(9,499)
14,546
12,681
$
9,968
$
5,047
282
1,681
$
$
132
1,968
$
$
-
-
$
$
$
$
Notes to the Consolidated Financial Statements
NOTE 1: - GENERAL
a.
General description of the Company and its activity
Kamada Ltd. and its subsidiaries
Kamada Ltd. ("the Company") is a plasma-derived protein therapeutics company with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its
proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a high purity, liquid form,
as well as other plasma-derived proteins. The Company's flagship product is "Glassia". In addition to Glassia, Kamada has a product line consisting of six other products which are
marketed in more than fifteen countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia.
The Company's activity is divided into two operating segments:
Proprietary Products
Develop and manufacture plasma-derived therapeutics and market them in more than 15 countries.
Distribution
Distribute imported drugs in Israel, which are manufactured by third parties, most of which are produced from plasma or its derivative products.
The Company's securities are listed for trading on the Tel Aviv stock exchange and on the NASDAQ.
b.
The Company has three wholly-owned subsidiaries – Kamada Inc and Bio-Kam Ltd which are not active and Kamada Biopharma Limited. In addition the Company owns 74% of
Kamada Assets Ltd ("Kamada Assets").
c.
Definitions
In these Financial Statements –
The Company
The Group
Subsidiary
- Kamada Ltd.
- The Company and its subsidiaries.
- A company which the Company has a control over (as defined in IFRS 10) and whose financial statements are consolidated with the Company's
Related parties
USD/$
NIS
Financial Statements.
- As defined in IAS 24.
- U.S. dollar.
- New Israeli Shekel
F - 8
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES
a.
Basis of presentation of financial statements
Kamada Ltd. and its subsidiaries
1.
These financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standard
Board.
2.
Measurement basis:
The Company's consolidated Financial Statements are prepared on a cost basis, except for financial instruments (including derivatives) at fair value through profit or loss and
other comprehensive income such as available for sales financial assets, employee benefit assets and employee benefit liabilities.
The Company has elected to present profit or loss items using the "function of expense" method.
b. The Company's operating cycle is one year.
c.
The consolidated financial statements comprise the financial statements of companies that are controlled by the Company (subsidiaries). Control is achieved when the Company is
exposed, or has rights, to variable returns from its involvement with the investee and has the ability to affect those returns through its power over the investee. The consolidation of the
financial statements commences on the date on which control is obtained and ends when such control ceases.
The financial statements of the Company and of the subsidiaries are prepared as of the same dates and periods. The consolidated financial statements are prepared using uniform
accounting policies by all companies in the Group. Significant intercompany balances and transactions and gains or losses resulting from intercompany transactions are eliminated in
full in the consolidated financial statements.
d.
Functional currency, presentation currency and foreign currency
1.
Functional currency and presentation currency
The consolidated financial statements are presented in U.S. dollars, which is the Company's functional and presentation currency.
2.
Transactions, assets and liabilities in foreign currency
Transactions denominated in foreign currency are recorded on initial recognition at the exchange rate at the date of the transaction. After initial recognition, monetary assets
and liabilities denominated in foreign currency are translated at the end of each reporting period into the functional currency at the exchange rate at that date. Exchange
differences are recognized in profit or loss. Non-monetary assets and liabilities measured at cost in a foreign currency are translated at the exchange rate at the date of the
transaction.
F - 9
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
e.
Cash equivalents
Kamada Ltd. and its subsidiaries
Cash equivalents are considered as highly liquid investments, including unrestricted short-term bank deposits with an original maturity of three months or less from the date of
purchase.
f. Short-term investments:
Short-term bank deposits with a maturity of more than three months from the deposit date but less than one year, available for sale financial investments (debentures) and financial
assets held for trading at fair value through profit or loss (debentures and stocks).
g.
Allowance for doubtful accounts
The allowance for doubtful accounts is determined in respect of specific debts whose collection, in the opinion of the Company's management, is doubtful. Impaired debts are
derecognized when they are assessed as uncollectible. As of December 31, 2017 there was no allowance for doubtful accounts and as of December 31, 2016, the balance of allowance
for doubtful accounts was $399 thousands.
h.
Inventories
Inventories are measured at the lower of cost and net realizable value. The cost of inventories comprises costs of purchase of raw and other materials and costs incurred in bringing
the inventories to their present location and condition. Net realizable value is the estimated selling price in the ordinary course of business.
Cost of inventories is determined as follows:
Raw materials
- At cost using the first-in, first-out method.
Work in process
- Direct costs and indirect costs calculated at average costs for the quarter of manufacturing including materials, labor and other direct and indirect
manufacturing costs on the basis of each batch.
Finished products
- Direct costs and indirect costs calculated at average costs for quarter of manufacturing including materials, labor and other direct and indirect
manufacturing costs on the basis of each batch.
Purchased products
- At cost on a "first in – first out" basis.
F - 10
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
Kamada Ltd. and its subsidiaries
The Company periodically evaluates the condition and age of inventories and accounts for impairment of inventories with a lower market value or which are slow moving.
Research and development costs
Research expenditures are recognized in profit or loss when incurred. An intangible asset arising from a development project or from the development phase of an internal project is
recognized if the Company can demonstrate the technical feasibility of completing the intangible asset so that it will be available for use or sale; the Company's intention to complete
the intangible asset and use or sell it; the Company's ability to use or sell the intangible asset; how the intangible asset will generate future economic benefits; the availability of
adequate technical, financial and other resources to complete the intangible asset; and the Company's ability to measure reliably the expenditure attributable to the intangible asset
during its development. Since the Company development projects are often subject to regulatory approval procedures and other uncertainties, the conditions for the capitalization of
costs incurred before receipt of approvals are not normally satisfied and therefore, development expenditures are recognized in profit or loss when incurred.
i.
Revenue recognition
Revenues are recognized in profit or loss when the revenues can be measured reliably, it is probable that the economic benefits associated with the transaction will flow to the
Company and the costs incurred or to be incurred in respect of the transaction can be measured reliably. In cases where the Company operates as a principal supplier and it exposed to
the risks and rewards associated with the transaction, revenues are presented on a gross basis. Revenues are measured at the fair value of the consideration received less any trade
discounts, volume rebates and returns.
The specific criteria for revenue recognition for the following types of revenues are:
-
-
Revenues from the sale of goods are recognized when all the significant risks and rewards of ownership of the goods have passed to the buyer and the seller no longer retains
continuing managerial involvement. The delivery date is usually the date on which ownership passes.
Agreements with multiple elements provide for varying consideration terms, such as upfront payments and milestone payments. Revenues from such agreements that do not
contain a general right of return and that are composed of multiple elements such as distribution exclusivity, license and services are allocated to the different elements and are
recognized in respect of each element separately. An element constitutes a separate accounting unit if and only if it has a separate value to the customer. Revenue from the
different element is recognized when the criteria for revenue recognition have been met and only to the extent of the consideration that is not contingent upon completion or
performance of future services in the contract.
F - 11
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
Kamada Ltd. and its subsidiaries
Revenue from milestone and upfront events stipulated in the agreements is recognized upon the occurrence of a substantive element specified in the agreement or as a measure
of substantive progress towards completion.
In events that the Company receives at no charge raw material, that is required for manufacturing one of the Company's products, the Company recorded the fair value of the
raw material used and sold as revenue and charged the same fair value to cost of revenue.
Deferred revenues
Deferred revenues include unearned amounts received from customers not yet recognized as revenues.
j.
Taxes on income
Taxes on income in profit or loss comprise current and deferred taxes. Current or deferred taxes are recognized in profit or loss, except to the extent that the tax arises from items
which are recognized directly in other comprehensive income or in equity.
1.
Current taxes:
The current tax liability is measured using the tax rates and tax laws that have been enacted or substantively enacted by the end of reporting period as well as adjustments
required in connection with the tax liability in respect of previous years.
2.
Deferred taxes:
Deferred taxes are computed in respect of temporary differences between the carrying amounts in the financial statements and the amounts attributed for tax purposes.
Deferred taxes are measured at the tax rates that are expected to apply when the asset is realized or the liability is settled, based on tax laws that have been enacted or
substantively enacted by the end of the reporting period.
Deferred tax assets are reviewed at the end of each reporting period and reduced to the extent that it is not probable that they will be utilized. Temporary differences for which
deferred tax assets had not been recognized are reviewed at the end of each reporting period and a respective deferred tax asset is recognized to the extent that their utilization
is probable.
Deferred taxes are offset in the statement of financial position if there is a legally enforceable right to offset a current tax asset against a current tax liability and the deferred
taxes relate to the same taxpayer and the same taxation authority.
F - 12
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
k.
Leases
The Group as lessee:
1.
Finance lease
Kamada Ltd. and its subsidiaries
Finance leases transfer to the Company substantially all the risks and benefits incidental to ownership of the leased asset. At the commencement of the lease term, the leased
assets are measured at the fair value of the leased asset or, if lower, at the present value of the minimum lease payments.
The leased asset is depreciated over the shorter of the lease term and the expected life of the leased asset.
2.
Operating lease
Lease agreements are classified as an operating lease if they do not transfer substantially all the risks and benefits incidental to ownership of the leased asset. Lease payments
are recognized as an expense in profit or loss on a straight-line basis over the lease term.
l.
Property, plant and equipment
Property, plant and equipment are measured at cost, including directly attributable costs and financing costs, less accumulated depreciation, accumulated impairment losses and any
related investment grants and excluding day-to-day servicing expenses. Cost includes spare parts and auxiliary equipment that can be used only in connection with the plant and
equipment.
The Company's assets include computer systems comprising hardware and software. Software forming an integral part of the hardware to the extent that the hardware cannot function
without the programs installed on it is classified as property, plant and equipment. In contrast, software that adds functionality to the hardware is classified as an intangible asset.
The cost of assets includes the cost of materials, direct labor costs, as well as any costs directly attributable to bringing the asset to the location and condition necessary for it to
operate in the manner intended by management.
Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows:
F - 13
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
Buildings
Machinery and equipment
Vehicles
Computers, software, equipment and office furniture
Leasehold improvements
Kamada Ltd. and its subsidiaries
%
Mainly %
2.5-4
10-20
15
6-33
(*)
4
15
15
33
10
(*) Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be
exercised) and the expected life of the improvement.
The useful life, depreciation method and residual value of an asset are reviewed at the year-end and any changes are accounted for prospectively as a change in accounting estimate.
Depreciation of an asset ceases at the earlier of the date that the asset is classified as held for sale and the date that the asset is derecognized.
m.
Impairment of non-financial assets
The Company evaluates the need to record an impairment of the carrying amount of non-financial assets whenever events or changes in circumstances indicate that the carrying
amount is not recoverable. If the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their recoverable amount.
The recoverable amount is the higher of fair value less costs of sale and value in use. In measuring value in use, the expected future cash flows are discounted using a pre-tax discount
rate that reflects the risks specific to the asset. The recoverable amount of an asset that does not generate independent cash flows is determined for the cash-generating unit to which
the asset belongs.
An impairment loss of an asset, is reversed only if there have been changes in the estimates used to determine the asset's recoverable amount since the last impairment loss was
recognized. Reversal of an impairment loss, as above, shall not be increased above the lower of the carrying amount that would have been determined (net of depreciation or
amortization) had no impairment loss been recognized for the asset in prior years and its recoverable amount.
F - 14
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
n.
Financial instruments
1.
Financial assets
Kamada Ltd. and its subsidiaries
Financial assets within the scope of IAS 39 are initially recognized at fair value plus directly attributable transaction costs, except for financial assets measured at fair value
through profit or loss.
After initial recognition, the accounting treatment of financial assets is based on their classification as follows:
a. Financial assets at fair value through profit or loss
Financial assets held for trading and derivative instruments that do not qualify for hedge accounting. Financial assets are classified as held for trading if they are
acquired for the purpose of selling or repurchasing in the near term.
b. Receivables
The Company has receivables that are financial assets with fixed or determinable payments that are not quoted in an active market.
c. Available for sale ("AFS") financial investments
AFS financial investments include debt securities. Debt securities in this category are those that are intended to be held for an indefinite period of time and that may be
sold in response to needs for liquidity or in response to changes in the market conditions.
The Company has classified all marketable securities as short-term, even though the stated maturity date may be one year or more beyond the current balance sheet
date, because it may sell these securities prior to maturity to meet liquidity needs or as part of risk versus reward objectives.
After initial measurement, AFS financial investments are subsequently measured at fair value with unrealized gains and losses recognized in other comprehensive
income ("OCI") until the investment is derecognized or the investment is determined to be impaired. Interest earned whilst holding AFS financial investments is
reported as interest income using the effective interest rate method.
F - 15
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
Kamada Ltd. and its subsidiaries
For AFS financial investments, the Company assesses at each reporting date whether there is objective evidence that an investment is impaired. For debt instruments
classified as AFS financial assets, objective evidence of impairment may arise as a result of one or more events that have a negative impact on the estimated future cash
flows of the asset since the recognition of the asset. Where there is evidence of impairment, the cumulative loss - measured as the difference between the acquisition
cost and the fair value - is reclassified from other comprehensive income and recognized as an impairment loss in profit or loss. In a subsequent period, the amount of
the impairment loss is reversed if the increase in fair value can be related objectively to an event occurring after the impairment was recognized. The amount of the
reversal, up to the amount of any previous impairment, is recorded in profit or loss.
2.
Financial liabilities
Financial liabilities within the scope of IAS 39 are initially measured at fair value.
After initial recognition, the accounting treatment of financial liabilities is based on their classification as follows:
a. Financial liabilities measured at amortized cost
Loans, including capital leases, are measured based on their terms at amortized cost using the effective interest method taking into account directly attributable
transaction costs.
b. Financial liabilities measured at fair value
Derivatives, including separated embedded derivatives, are classified as held for trading unless they are designated as effective hedging instruments.
3.
Fair value
Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
A fair value measurement of a non-financial asset takes into account a market participant's ability to generate economic benefits by using the asset in its highest and
best use or by selling it to another market participant that would use the asset in its highest and best use.
F - 16
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
Kamada Ltd. and its subsidiaries
The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of
relevant observable inputs and minimizing the use of unobservable inputs.
All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy, described as follows, based on
the lowest level input that is significant to the fair value measurement as a whole:
- Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities.
- Level 2 - inputs other than quoted prices included within Level 1 that are observable either directly or indirectly.
- Level 3 - inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data).
4.
Offsetting financial instruments
Financial assets and financial liabilities are offset and the net amount is presented in the statement of financial position if there is a legally enforceable right to set off the
recognized amounts and there is an intention either to settle on a net basis or to realize the asset and settle the liability simultaneously.
The right of set-off must be legally enforceable not only during the ordinary course of business of the parties to the contract but also in the event of bankruptcy or insolvency
of one of the parties. In order for the right of set-off to be currently available, it must not be contingent on a future event, there may not be periods during which the right is not
available, or there may not be any events that will cause the right to expire.
5.
De-recognition of financial instruments
a. Financial assets
A financial asset is derecognized when the contractual rights to the cash flows from the financial asset expire or the Company has transferred its contractual rights to
receive cash flows from the financial asset or assumes an obligation to pay the cash flows in full without material delay to a third party and has transferred substantially
all the risks and rewards of the asset, or has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset.
F - 17
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
b. Financial liabilities
Kamada Ltd. and its subsidiaries
A financial liability is derecognized when it is extinguished, that is when the obligation is discharged or cancelled or expires. A financial liability is extinguished when
the debtor (the Company) discharges the liability by paying in cash, other financial assets, goods or services or is legally released from the liability.
o.
Derivative financial instruments designated as hedges
The Company enters into contracts for derivative financial instruments such as forward currency contracts and cylinder strategy in respect of foreign currency to hedge risks
associated with foreign exchange rates fluctuations. Such derivative financial instruments are carried as financial assets when the fair value is positive and as financial liabilities when
the fair value is negative.
At the inception of a hedge relationship, the Company formally designates and documents the hedge relationship to which the Company wishes to apply hedge accounting and the
risk management objective and strategy for undertaking the hedge. The hedge effectiveness is assessed at the end of each reporting period.
Cash flow hedges
The effective portion of the gain or loss on the hedging instrument is recognized as other comprehensive income (loss), while any ineffective portion is recognized immediately in
profit or loss.
Amounts recognized as other comprehensive income (loss) are reclassified to profit or loss when the hedged transaction affects profit or loss, such as when the hedged income or
expense is recognized or when a forecast payment occurs.
If the forecast transaction or firm commitment is no longer expected to occur, amounts previously recognized in equity are reclassified to profit or loss. If the hedging instrument
expires or is sold, terminated or exercised, or if its designation as a hedge is revoked, amounts previously recognized in equity remain in equity until the forecast transaction or firm
commitment occurs.
p.
Accrued expenses
A provision in accordance with IAS 37 is recognized when the Group has a present (legal or constructive) obligation as a result of a past event, it is expected to require the use of
economic resources to clear the obligation and a reliable estimate can be made of it.
r.
Employee benefit liabilities
The Company has several employee benefit plans:
1.
Short-term employee benefits
Short-term employee benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are
rendered. A liability in respect of a cash bonus is recognized when the Company has a legal or constructive obligation to make such payment as a result of past service
rendered by an employee and a reliable estimate of the amount can be made.
F - 18
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
2.
Post-employment benefits
Kamada Ltd. and its subsidiaries
The post-employment benefits plans are normally financed by contributions to insurance companies and classified as defined contribution plans or as defined benefit plans.
The Company has defined contribution plans pursuant to Section 14 to the Israeli Severance Pay Law under which the Company pays fixed contributions to certain employees
under section 14 and will have no legal or constructive obligation to pay further contributions.
Contributions to the defined contribution plan in respect of severance or retirement pay are recognized as an expense when contributed concurrently with performance of the
employee's services.
In addition the Company operates a defined benefit plan in respect of severance pay pursuant to the Israeli Severance Pay Law. According to the Law, employees are entitled to
severance pay upon dismissal or retirement. The liability for termination of employment is measured using the projected unit credit method. The amounts are presented based
on discounted expected future cash flows using a discount rate determined by reference to market yields at the reporting date on high quality corporate bonds that are linked to
the Consumer Price Index with a term that is consistent with the estimated term of the severance pay obligation.
In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies ("the plan assets"). Plan
assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan assets are not available to the Company's own creditors and cannot be
returned directly to the Company.
The liability for employee benefits shown in the statement of financial position reflects the present value of the defined benefit obligation less the fair value of the plan assets.
Re-measurements of the net liability are recognized in other comprehensive income in the period in which they occur.
q.
Share-based payment transactions
The Company's employees and other service providers are entitled to remuneration in the form of equity-settled share-based payment transactions.
Equity-settled transactions
The cost of equity-settled transactions (options and restricted shares) with employees is measured at the fair value of the equity instruments granted at grant date. The fair value of
options is determined using a standard option pricing model. The fair value of restricted shares is determined using the share price at the grant date.
F - 19
Notes to the Consolidated Financial Statements
NOTE 2: -
SIGNIFICANT ACCOUNTING POLICIES (CONT.)
Kamada Ltd. and its subsidiaries
As for other service providers, the cost of the transactions is measured at the fair value of the goods or services received as consideration for equity instruments. In cases where the
fair value of the goods or services received as consideration of equity instruments cannot be measured, they are measured by reference to the fair value of the equity instruments
granted.
The cost of equity-settled transactions is recognized in profit or loss together with a corresponding increase in shareholder's equity during the period which the performance and/or
service conditions are to be satisfied ending on the date on which the relevant employees become entitled to the award ("the vesting period"). The cumulative expense recognized for
equity-settled transactions at the end of each reporting period until the vesting date reflects the extent to which the vesting period has expired and the Company’s best estimate of the
number of equity instruments that will ultimately vest.
No expense is recognized for awards that do not ultimately vest.
If the Company modifies the conditions on which equity-instruments were granted, an additional expense is recognized for any modification that increases the total fair value of the
share-based payment arrangement or is otherwise beneficial to the employee/other service provider at the modification date.
r.
Income (loss) per Share
Income (loss) per share is calculated by dividing the income (loss) attributable to Company shareholders by the weighted number of outstanding ordinary shares during the period.
Ordinary shares underlying shares options or restricted Shares are only included in the calculation of diluted income (loss) per share when their impact dilutes the income (loss) per
share. Furthermore, potential ordinary shares converted during the period are included under diluted income (loss) per share only until the conversion date, and from that date on are
included under basic income (loss) per share.
s.
Reclassification of prior years' amounts
Certain amounts in prior years' financial statements have been reclassified to conform to the current year's presentation. The reclassification had no effect on previously reported net
loss or shareholders' equity.
F - 20
Notes to the Consolidated Financial Statements
Kamada Ltd. and its subsidiaries
NOTE 3: -
SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUMPTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS
Judgments
Revenue
The Company assesses the criteria for recognition of revenue related to up-front payments and multiple components as outlined by IAS 18, Revenue. Judgment is necessary to
determine over which period the Company will satisfy its obligations related to up-front payments and when components can be recognized separately and the allocation of the
related consideration to each component. For additional information, refer to Note 17a.
Estimates and assumptions
The key assumptions made in the financial statements concerning uncertainties at the end of the reporting period and the critical estimates computed by the Company that may result
in a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below.
- Legal claims
In estimating the likelihood of outcome of legal claims filed against the Company and its investees, the Company relies on the opinion of its legal counsel. These estimates are
based on the legal counsel's best professional judgment, taking into account the stage of proceedings and historical legal precedents in respect of the different issues. Since the
outcome of the claims will be determined in courts, the results could differ from these estimates.
- Pensions and other post-employment benefits
The liability in respect of post-employment defined benefit plans is determined using actuarial valuations. The actuarial valuation involves making assumptions about, among
others, discount rates, expected rates of return on assets, future salary increases and mortality rates. Due to the long-term nature of these plans, such estimates are subject to
significant uncertainty.
- Determining the fair value of share-based payment transactions
Estimating fair value for share-based payment transactions requires determination of the most appropriate valuation model, which depends on the terms and conditions of the
grant. This estimate also requires determination of the most appropriate inputs to the valuation model including the expected life of the share option or appreciation right, volatility
and dividend yield and making assumptions about them.
- Provisions for clinical trial and related expenses
Accrued expenses costs for clinical trial activities performed by third parties, are based on estimates on the progress of completion of the clinical trials or services, as of the end of
each reporting period, pursuant to the contract with the third parties, and the agreed upon fee to be paid for such services.
F - 21
Notes to the Consolidated Financial Statements
Kamada Ltd. and its subsidiaries
NOTE 3: -
SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUMPTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS (CONT.)
- Capitalization of materials for clinical trials and inventory designated for R&D activities
The Company recognizes inventory produced for commercial sale, including costs incurred prior to regulatory approval but subsequent to the filing of a regulatory request when
the Company has determined that the inventory has probable future economic benefit. Inventory is not recognized prior to completion of a phase III clinical trial. For products
with an approved indication, raw materials and purchased drug product associated with development programs are included in inventory and charged to research and
development expense when consumed. For products without an approved indication, drug product is charged to research and development expense.
NOTE 4: -
DISCLUSURE OF NEW IFRS IN THE PERIOD
a.
IFRS 15 – Revenues from contracts with customers
The standard outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue
recognition guidance, including industry-specific guidance. The core principle of the new standard is for companies to recognize revenue to depict the transfer of goods or services to
customers in amounts that reflect the consideration (that is, payment) to which the Company expects to be entitled in exchange for those goods or services. The new standard also will
result in enhanced disclosures about revenue, provide guidance for transactions that were not previously addressed comprehensively (for example, service revenue and contract
modifications) and improve guidance for multiple-element arrangements.
IFRS 15 is to be applied retrospectively for annual periods beginning on or after January 1, 2018. IFRS 15 allows an entity to choose to apply a modified retrospective approach.
During 2017, the Company performed an assessment of IFRS 15 impact as described below.
The Company is in the business of sale of plasma-derived therapeutics products and distribution in Israel of drugs manufacture by other companies. The products are sold on their
own in separate identified contracts with customers. In addition, the Company received certain milestone and advances from Commercialization, Distribution and License
Agreements with strategic partners.
F - 22
Notes to the Consolidated Financial Statements
NOTE 4: -
DISCLUSURE OF NEW IFRS IN THE PERIOD (CONT.)
The Company performed the following preliminary assessment of IFRS 15:
(1) Sale of goods
Kamada Ltd. and its subsidiaries
Application of the IFRS 15 to contracts with customers in which the sale of product is generally expected to be the only performance obligation does not have any impact on
the Company’s profit or loss following implementation of IFRS 15. The revenue recognition occurs at a point in time when control of the asset is transferred to the customer,
generally on delivery of the goods.
In implementation of IFRS 15, the Company is considering the following:
(1) Variable consideration
Some contracts with customers provide a right of return, trade discounts or volume rebates. Currently, the Company recognizes revenue from the sale of goods measured at the
fair value of the consideration received or receivable, net of returns and allowances, trade discounts and volume rebates. If revenue cannot be reliably measured, the Company
defers revenue recognition until the uncertainty is resolved. Such provisions give rise to variable consideration under IFRS 15, which will be required to be estimated at
contract inception.
IFRS 15 requires that the variable consideration be estimated conservatively to prevent over-recognition of revenue.
The Company continues to assess individual contracts to determine the estimated variable consideration and related constraint. There is no impact of IFRS 15on the financial
statements.
(2) Upfront and milestone payments
Agreements with strategic partners that include upfront and milestone payments contain a performance obligation that is satisfied over time given that the customer
simultaneously receives and consumes the benefits provided by the Company. Currently, the Company defers the upfront payments and recognizes revenue over time by
reference to the stage of completion.
Under IFRS 15, the Company would continue to recognize revenue for upfront payments over time rather than at a point of time. The Company identified the existence of a
significant financing component resulting from an upfront payment. As of January 1, 2018 an amount of $ 757 thousands will be recognized as an increase of the deferred
revenue against accumulated deficit and through 2018 will be recognize as revenue in the financial statements. Other than the financing component, there was no impact on the
financial statement due to IFRS 15 implementation.
(3) Presentation and disclosure requirements
IFRS 15 provides presentation and disclosure requirements, which are more detailed than under current IFRS. The presentation requirements represent a significant change
from current practice and may significantly expand the disclosures required in Company’s financial statements. Many of the disclosure requirements in IFRS 15 are completely
new. In 2017 the Company updated the internal controls, policies and procedures necessary to collect and disclose the required information.
F - 23
Notes to the Consolidated Financial Statements
NOTE 4: -
DISCLUSURE OF NEW IFRS IN THE PERIOD (CONT.)
b.
IFRS 9 - Financial Instruments
Kamada Ltd. and its subsidiaries
In July 2014, the IASB completed the final element of its comprehensive response to the financial crisis by issuing IFRS 9 Financial Instruments. The package of improvements
introduced by IFRS 9 includes a logical model for classification and measurement, a single, forward-looking ‘expected loss’ impairment model and a substantially-reformed approach
to hedge accounting. Certain securities that are currently measured at Fair Value through profit and lost will be measured at Fair Value through other comprehensive income (loss) due
to implementation of IFRS 9. In addition, the Company will measure expected credit loss of the securities that will be measured at fair value through other comprehensive income
(loss). IFRS 9 is to be applied for annual periods beginning on January 1, 2018. The Company does not there to be any material impact from the adoption of IFRS 9 on the financial
statements.
c.
IFRS 16 – Leases
In January 2016, the IASB issued IFRS 16, Leases. IFRS 16, that replaces IAS 17, Leases, will only imply insignificant changes to the accounting for lessors. For
lessees, the accounting will change significantly, as all leases (except short term leases and small asset leases) will be recognized on balance sheet.
Initially, the lease liability and the right-of-use asset is measured at the present value of future lease payments (defined as economically unavoidable
payments). The right-of-use asset is subsequently depreciated in a similar way to other assets such as tangible assets, i.e. typically in a straight-line over
the lease term. The new Standard is effective for annual periods beginning on or after January 1, 2019. Earlier application is permitted provided that IFRS 15, "Revenue from
Contracts with Customers", is applied concurrently. The Company is evaluating the possible impact of IFRS 16 but is presently unable to assess its effect, on the financial statements.
d.
IFRIC Interpretation 23 - Uncertainty over Income Tax Treatment
The Interpretation clarifies application of recognition and measurement requirements in IAS 12 Income Taxes when there is uncertainty over income tax treatment. In determining
taxable profit (tax loss), tax bases, unused tax losses, unused tax credits and tax rates, an entity must consider the probability that a taxation authority will accept an uncertain tax
treatment.
The interpretation is effective for annual reporting periods beginning on or after 1 January 2019. The Company is evaluating the possible impact of IFRIC Interpretation 23 but is
presently unable to assess its effect, on the financial statements.
F - 24
Notes to the Consolidated Financial Statements
NOTE 5: -
CASH AND CASH EQUIVALENTS
Cash and deposits for immediate withdrawal
Cash equivalents in USD deposits (1)
Cash equivalents in NIS deposits (2)
(1)
(2)
The deposits bear interest of 1.53% and 1.12% per year, as of December 31, 2017 and 2016, respectively.
The deposits bear interest of 0.01% per year, as of each December 31, 2017 and 2016.
NOTE 6: -
SHORT-TERM INVESTMENTS
Marketable securities (equity and debt) at fair value through profit or loss
Bank deposits in USD (1)
Available for sale debt securities
(1)
The deposits bear interest of 1.70%-2.3% and 1.69%- 1.84% per year, as of December 31, 2017 and 2016, respectively.
NOTE 7: - TRADE RECEIVABLES, NET
Open accounts:
In NIS
In USD
Checks receivable
Less allowance for doubtful accounts (1)
Trade receivables, net
F - 25
Kamada Ltd. and its subsidiaries
December 31,
2017
2016
In thousands
$
$
8,539
4,001
141
$
12,681
$
7,891
2,001
76
9,968
December 31,
2017
2016
In thousands
$
$
1,663
20,078
8,597
1,490
8,010
9,164
$
30,338
$
18,664
December 31,
2017
2016
In thousands
$
$
8,263
22,284
30,547
115
30,662
-
9,326
10,816
20,142
45
20,187
(399)
$
30,662
$
19,788
Notes to the Consolidated Financial Statements
NOTE 7: - TRADE RECEIVABLES, NET (CONT.)
(1)
Allowance for doubtful accounts:
December 31, 2016
Bad debt recognition
December 31, 2017
An analysis of past due but not impaired trade receivables with reference to reporting date:
Neither past due
nor impaired
Up to
30 Days
30-60
Days
Past due trade receivables with aging of
60-90
Days
In thousands
90-120
Days
Kamada Ltd. and its subsidiaries
$
$
(399)
399
-
Over 120 days
Total
December 31, 2017
December 31, 2016
$
$
29,692
17,769
680
$
1,891
$
21
$
24
$
152
$
43
$
2
$
6
$
-
$
30,547
10
$
19,743
NOTE 8: - OTHER ACCOUNTS RECEIVABLES
Materials for clinical trials and inventory designated for R&D activities
Prepaid expenses
Government authorities
Accrued interest
Other
NOTE 9: – INVENTORIES
Finished products
Purchased products
Work in progress
Raw materials
December 31,
2017
2016
In thousands
$
$
635
822
563
66
46
$
2,132
$
1,229
1,057
374
82
321
3,063
December 31,
2017
2016
In thousands
$
$
5,168
2,695
6,159
7,048
6,542
5,607
6,227
7,218
$
21,070
$
25,594
(1)
During the years 2017, 2016 and 2015, the Company recognized, at cost of revenues, as impairment for inventories carried at net realizable value totaled of $460 thousands, $544
thousands and $470 thousands, respectively.
F - 26
Notes to the Consolidated Financial Statements
NOTE 10: – PROPERTY, PLANT AND EQUIPMENT
a.
Composition and movement:
2017
Cost
Kamada Ltd. and its subsidiaries
Land
and Buildings(1)
Machinery
and
Equipment
(1) (2)
Computers,
Software,
Equipment and
Office Furniture
Vehicles
In thousands
Leasehold
Improvements
Total
Balance at January 1, 2017
Additions
Sale and write-off
Balance as of December 31, 2017
Accumulated Depreciation
Balance as of January 1, 2017
Depreciation and impairment
Sale and write-off
Balance as of December 31, 2017
$
$
27,618
781
-
28,399
$
26,485
3,151
(34)
29,602
12,606
1,310
-
13,916
19,972
1,492
(34)
21,430
Depreciated cost as of December 31, 2017
$
14,483
$
8,172
$
$
94
-
(28)
66
86
1
(28)
59
7
$
5,520
1,002
-
6,522
4,559
635
-
5,194
$
1,052
1,196
(975)
1,273
967
85
(967)
85
60,769
6,130
(1,037)
65,862
38,190
3,523
(1,029)
40,684
1,328
$
1,188
$
25,178
2016
Cost
Land
and Buildings(1)
Machinery
and
Equipment
(1) (2)
Computers,
Software,
Equipment and
Office Furniture
Vehicles
Leasehold
Improvements
Total
Balance at January 1, 2016
Additions
Sale and write-off
Balance as of December 31, 2016
Accumulated Depreciation
Balance as of January 1, 2016
Depreciation and impairment
Sale and write-off
Balance as of December 31, 2016
$
$
26,701
963
(46)
27,618
$
24,111
3,220
(846)
26,485
11,237
1,402
(33)
12,606
19,310
1,355
(693)
19,972
Depreciated cost as of December 31, 2016
$
15,012
$
6,513
$
F - 27
In thousands
$
94
-
94
83
3
86
8
$
5,156
507
(143)
5,520
4,136
564
(141)
4,559
$
1,079
62
(89)
1,052
1,012
44
(89)
967
57,141
4,752
(1,124)
60,769
35,778
3,368
(956)
38,190
961
$
85
$
22,579
Notes to the Consolidated Financial Statements
NOTE 10: – PROPERTY, PLANT AND EQUIPMENT (CONT.)
Kamada Ltd. and its subsidiaries
(1)
(2)
Including labor costs charged in 2017 and 2016 to the cost of facilities, machinery and equipment in the amount of $431 thousands and $510 thousands, respectively.
Including financing costs of $44 thousands and $11 thousands capitalized in 2017 and 2016 respectively, to the cost of machinery and equipment.
b.
c.
As for liens, refer to Note 18.
Capitalized leasing rights of land from the Israel land administration.
Under finance lease
$
1,016
$
1,029
The Group has capitalized leasing rights from the Israel Land Administration for an area of 16,880 m² in Beit Kama containing the Group's structures. The sum attributed to
capitalized rights is presented under property, plant and equipment and is depreciated over the leasing period, which includes the option period.
During 2010, the Company signed an agreement with the Israel Land Administration to consolidate its leasing rights and extend the lease period to 2058, including an extension
option for additional 49 years
December 31,
2017
2016
In thousands
NOTE 11: - OTHER LONG TERM ASSETS
Long term pre-paid expenses
NOTE 12: - TRADE PAYABLES
Open debts mainly in USD
Open debts in NIS
Notes payable
December 31,
2017
2016
In thousands
$
49
$
40
December 31,
2017
2016
In thousands
$
$
11,246
6,789
18,035
1
11,187
5,038
16,225
52
$
18,036
$
16,277
F - 28
Notes to the Consolidated Financial Statements
NOTE 13: – OTHER ACCOUNTS PAYABLES
Employees and payroll accruals
Derivatives financial instruments
Accrued Expenses and Others
NOTE 14: - LOANS AND CAPITAL LEASES
Total loans and capital leases (1)
Less current maturities
Long term loans and capital leases
Kamada Ltd. and its subsidiaries
December 31,
2017
2016
In thousands
$
$
4,735
8
1,077
$
5,820
$
4,135
32
1,447
5,614
December 31,
2017
2016
In thousands
1,984
614
1,370
$
1,776
412
1,364
$
(1)
The capital lease balance was $274 thousands and $103 thousands, as of December 31, 2017 and 2016, respectively.
Bank loans
During 2017 and 2016, the Company received loans at an amount of NIS 1,000 thousands ($279 thousands) and NIS 6,585 thousands ($ 1,701 thousands). The loans are payable over
60 equal monthly installments. The loans bear fixed interest rate in the range of 3.15% -3.55%. As for pledges, refer to Note 18.
NOTE 15: - FINANCIAL INSTRUMENTS
a.
Classification of financial assets and liabilities
The financial assets and financial liabilities in the balance sheet are classified by groups of financial instruments in pursuant to IAS 39:
Financial assets
Financial assets at fair value through profit or loss:
Marketable securities (equity and debt)
Financial assets at fair value through other comprehensive income (loss)-
Available for sale debt securities-
Financial assets at cost:
Cash
Short term bank deposits
Financial liabilities
Financial liabilities at fair value:
Derivatives instruments
Financial liabilities measured at amortized cost:
Bank loans and capital leases
F - 29
December 31,
2017
2016
In thousands
$
1,663
$
8,597
8,539
24,220
43,019
$
8
$
1,984
1,992
$
$
$
$
1,490
9,164
7,891
10,087
28,632
32
1,776
1,808
Notes to the Consolidated Financial Statements
NOTE 15: - FINANCIAL INSTRUMENTS (CONT.)
b.
Financial risk factors
Kamada Ltd. and its subsidiaries
The Company's activities expose it to various financial risks, such as market risk (foreign currency risk, interest rate risk and price risk), credit risk and liquidity risk. The Company's
investment policy focuses on activities that will preserve the Company's capital. The Company utilized derivatives to hedge certain exposures to risk.
Risk management is the responsibility of the Company CEO and CFO, in accordance with the policy approved by the Board of Directors. The Board of Directors provides principles
for the overall risk management.
1.
Market risks
a)
Foreign exchange risk
The Company operates in an international environment and is exposed to foreign exchange risk resulting from the exposure to different currencies, mainly the NIS.
Foreign exchange risks arise from recognized assets and liabilities denominated in a foreign currency other than the functional currency, such as customers, suppliers
and credit.
As of December 31, 2017, the Company has a position in financial derivatives intended to hedge changes in the exchange rate of the USD vs. the NIS (see also f.
below).
b)
Price risk
As of December 31, 2017, the Company has financial instruments, shares and debentures, classified as financial assets measured at fair value through profit or loss and
Available for sale financial investments, for which the Company is exposed to risk of fluctuations in the security price that is determined by reference to the quoted
market price.
2.
Credit risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, short-term bank deposits,
marketable securities, trade receivables and foreign currency derivative contracts.
a)
Trade receivables:
The Company regularly monitors the credit extended to its customers and their general financial condition, and, when necessary, requires collateral as security for these
debts such as letters of creditor and down payments. In addition, the Company partially insures its overseas sales with foreign trade risk insurance.
F - 30
Notes to the Consolidated Financial Statements
NOTE 15: - FINANCIAL INSTRUMENTS (CONT.)
Kamada Ltd. and its subsidiaries
The Company keeps constant track of customer debt and the Financial Statements include an allowance for doubtful accounts that adequately reflects, in the Company's
assessment, the loss embodied in the debts the collection of which is in doubt.
The Company’s maximum exposure to credit risk for the components of the statement of financial position as of December 31, 2017 and 2016 is the carrying amount of
trade receivables.
b)
Cash and cash equivalent and short term investments:
The Company holds cash, cash equivalents, short term deposits and other financial instruments at a major financial institutions in Israel. In accordance with Company
policy, evaluations of the relative strength of credit of the various financial institutions are made on an ongoing basis.
Short-term investments include short-term deposits with low risk for a period less than one year. The Company’s marketable securities consist of investment-grade
corporate bonds, U.S., European and Israeli governments bonds and equity investments. The Company’s investment policy, limits the amount the Company may invest
in any one type of investment or issuer and the average maturities of the bond portfolio, thereby reducing credit risk concentrations.
The Company has not experienced any significant losses on its short term investments.
c) Foreign currency derivative contracts:
The Company is exposed to foreign currency exchange movements, primarily in Israel. Consequently, it enters into various foreign currency exchange contracts with
major financial institutions.
3.
Liquidity risk
The table below summarizes the maturity profile of the Company's financial liabilities based on contractual undiscounted payments:
December 31, 2017
Less than one
year
1 to 2
2 to 3
In thousands
3 to 5
Total
Trade payables
Other accounts payables
Long term loans and capital leases (including interest)
$
18,036
5,820
669
-
-
634
-
-
532
- $
-
260
18,036
5,820
2,095
$
24,525
$
634 $
532 $
260 $
25,951
F - 31
Notes to the Consolidated Financial Statements
NOTE 15: - FINANCIAL INSTRUMENTS (CONT.)
December 31, 2016
Kamada Ltd. and its subsidiaries
Less than one
year
1 to 2
2 to 3
In thousands
3 to 5
Total
Trade payables
Other accounts payables
Long term loan and capital leases (including interest)
$
16,277
5,614
464
-
-
461
-
-
429
- $
-
549
16,277
5,614
1,903
$
22,355
$
461 $
429 $
549 $
23,794
Changes in liabilities arising from financing activities
Bank loans
Capital leases
Total
c.
Fair value
January 1, 2017
Payments
Foreign
exchange
movement
Cash from new
loans
New leases
December 31,
2017
1,673
103
1,776
(419)
(111)
(530)
In thousands
177
-
177
279
-
279
-
282
282
1710
274
1984
The following table demonstrates the carrying amount and fair value of the financial instruments presented in the financial statements not at fair value:
Financial liabilities
Bank loans and capital Leases
Carrying Amount
December 31,
Fair Value
December 31,
2017
2016
2017
2016
In thousands
$
1,984
$
1,776
$
1,984
$
1,761
The fair value of the bank loans and capital leases was based on standard pricing valuation model such as DCF which considers the present value of future cash flows discounted at
the interest rate that reflects market conditions (Level 3).
The carrying amount of cash and cash equivalents, short term bank deposits, trade and other receivables, trade and other payables approximates their fair value, due to the short term
maturities of the financial instruments.
F - 32
Notes to the Consolidated Financial Statements
NOTE 15: - FINANCIAL INSTRUMENTS (CONT.)
d.
Classification of financial instruments by fair value hierarchy
Financial assets (liabilities) measured at fair value:
December 31, 2017
Marketable securities at fair value through profit or loss:
Equity shares
Mutual funds
Debt securities (corporate and government)
Derivatives instruments
Available for sale debt securities (corporate and government)
December 31, 2016
Marketable securities at fair value through profit or loss:
Equity shares
Mutual funds
Debt securities (corporate and government)
Derivatives instruments
Available for sale debt securities (corporate and government)
Kamada Ltd. and its subsidiaries
Level 1
Level 2
In thousands
$
$
$
$
77
456
1,130
-
-
1,663
$
$
-
-
-
(8)
8,597
8,589
Level 1
Level 2
In thousands
70
388
1,032
-
-
1,490
$
$
-
-
-
(32)
9,164
9,132
During 2017 there was no transfer due to the fair value measurement of any financial instrument from Level 1 to Level 2, and furthermore, there were no transfers to or from Level 3
due to the fair value measurement of any financial instrument.
Sensitivity test to changes in market price of listed Securities
Gain (loss) from change:
5% increase in market price
5% decrease in market price
Sensitivity test to changes in foreign currency:
Gain (loss) from change:
5% increase in NIS
5% decrease in NIS
5% increase in Euro
5% decrease in Euro
F - 33
December 31,
2017
2016
In thousands
$
$
$
$
$
$
513
$
(513) $
(143) $
143
$
(135) $
135
$
535
(535)
19
(19)
(184)
184
Notes to the Consolidated Financial Statements
NOTE 15: - FINANCIAL INSTRUMENTS (CONT.)
Sensitivity tests and principal work assumptions
Kamada Ltd. and its subsidiaries
The selected changes in the relevant risk variables were determined based on management's estimate as to reasonable possible changes in these risk variables.
The Company has performed sensitivity tests of principal market risk factors that are liable to affect its reported operating results or financial position. The sensitivity tests present the
profit or loss in respect of each financial instrument for the relevant risk variable chosen for that instrument as of each reporting date. The test of risk factors was determined based on
the materiality of the exposure of the operating results or financial condition of each risk with reference to the functional currency and assuming that all the other variables are
constant.
e.
Linkage terms of financial liabilities by groups of financial instruments pursuant to IAS 39:
In NIS:
Bank loans and capital leases measured at amortized cost
f.
Derivatives and hedging:
Derivatives instruments not designated as hedging
December 31,
In thousands
2017
2016
$
1,984
$
1,776
The Company has foreign currency forward contracts designed to protect it from exposure to fluctuations in exchange rates, mainly of NIS and EUR, in respect of its transactions for
debt from customers' debt, to service providers and inventory. Foreign currency forward contracts are not designated as cash flow hedges, fair value or net investment in a foreign
operation. These derivatives are not considered as hedge accounting. As of December 31, 2017 the fair value of the derivative instruments not designated as hedging was a liability of
$60 thousands. The open transactions for those derivatives were in an amount of $5.8 million.
Cash flow hedges:
As of December 31, 2017, the Company held NIS/USD hedging contracts (cylinder contracts) designated as hedges of expected future salaries expenses and for expected future
purchases from Israeli suppliers.
The main terms of these positions were set to match the terms of the hedged items. As of December 31, 2017 the fair value of the derivative instruments designated as hedge
accounting was an asset of $52 thousands. The open transactions for those derivatives were in an amount of $770 thousands.
Cash flow hedges of the expected salaries expenses in December 31, 2017 was estimated as highly effective and accordingly a net unrecognized loss was recorded in other
comprehensive income in the amount of $71 thousands.
F - 34
Notes to the Consolidated Financial Statements
NOTE 16: - EMPLOYEE BENEFIT LIABILITIES, NET
Employee benefits consist of short-term benefits and post-employment benefits.
a.
Post-employment benefits:
Kamada Ltd. and its subsidiaries
According to the labor laws and Severance Pay Law in Israel, the Company is required to pay compensation to an employee upon dismissal or retirement or to make current
contributions in defined contribution plans pursuant to Section 14 to the Severance Pay Law, as specified below. The Company's liability is accounted for as a post-employment
benefit only for employees not under Section 14. The computation of the Company's employee benefit liability is made in accordance with a valid employment contract or a collective
employees agreement based on the employee's salary and employment term which establish the entitlement to receive the compensation.
The post-employment employee benefits are normally financed by contributions classified as defined benefit plans, as detailed below:
1.
Defined contribution deposit:
The Company’s agreements with part of its employees are in accordance with section 14 of the Israeli Severance Pay Law. Payments in accordance with Section 14 release the
Company from any future severance liabilities in respect of those employees. The expenses for the defined benefit deposit in 2017, 2016 and 2015 were $ 884 thousands, $
669 thousands and $702 thousands, respectively.
2.
Defined benefit plans:
The Company accounts for the payment of compensation, as a defined benefit plan for which an employee benefit liability is recognized and for which the Company deposits
amounts in a long-term employee benefit fund and in qualifying insurance policies.
3.
Expenses recognized in comprehensive income (loss):
Current service cost
Interest expenses, net
Current service cost (income) due to the transfer of real yield from the compensation component to the
royalties' component in executive insurance policies before 2004
Total employee benefit expenses
Actual (negative) return on plan assets
F - 35
2017
Year Ended
December 31,
2016
In thousands
2015
$
$
$
356 $
23
(7)
372 $
359 $
20
5
384 $
119 $
22 $
391
18
(10)
399
(12)
Notes to the Consolidated Financial Statements
NOTE 16: - EMPLOYEE BENEFIT LIABILITIES, NET (CONT.)
The expenses are presented in the Statement of Comprehensive income (loss) as follows
Cost of revenues
Research and development
Selling and marketing
General and administrative
4.
The plan assets (liabilities), net:
Defined benefit obligation
Fair value of plan assets
Total liabilities, net
5.
Changes in the present value of defined benefit obligation
Balance at January 1,
Interest costs
Current service cost
Benefits paid
Demographic assumptions
Financial assumptions
Past Experience
Currency Exchange
Balance at December 31,
* Represent an amount of less than 1 thousands
6.
Plan assets
a)
Plan assets
Plan assets comprise assets held by a long-term employee benefit funds and qualifying insurance policies.
F - 36
Kamada Ltd. and its subsidiaries
2017
$
Year Ended
December 31,
2016
In thousands
2015
211 $
57
16
88
228 $
62
13
81
$
372 $
384 $
209
90
18
82
399
December 31,
2017
2016
In thousands
$
$
5,907 $
4,763
1,144 $
5,235
4,513
722
2017
2016
In thousands
$
5,235 $
151
356
(641)
(28)
254
6
574
5,907 $
$
5,425
141
359
(650)
(17)
*
(104)
81
5,235
Notes to the Consolidated Financial Statements
NOTE 16: - EMPLOYEE BENEFIT LIABILITIES, NET (CONT.)
b)
Changes in the fair value of plan assets
Kamada Ltd. and its subsidiaries
2017
2016
In thousands
Balance at January 1,
$
4,513 $
4,638
Expected return
Contributions by employer
Benefits paid
Demographic assumptions
Financial assumptions
Past Experience
Current service cost due to the transfer of real yield from the compensation component to the royalties component in
executive insurance policies before 2004
Currency exchange
Balance at December 31,
7.
The principal assumptions underlying the defined benefit plan
Discount rate of the plan liability
Future salary increases
127
227
(586)
1
1
(11)
7
484
121
311
(522)
1
-
(100)
(5)
69
$
4,763 $
4,513
2017
2016
%
2015
2.27
3.72
4
4
2.6
4
The sensitivity analyses below have been determined based on reasonably possible changes of the principal assumptions underlying the defined benefit plan as mentioned above,
occurring at the end of the reporting period.
If the discount rate would be one percent higher (lower), the defined benefit obligation would decrease (increase) by $309 thousands ($380 thousands) if all other assumptions
were held constant.
If the expected salary growth would increase (decrease) by 1% the defined benefit obligation would increase (decrease) by $362 thousands ($298 thousands).
F - 37
Notes to the Consolidated Financial Statements
NOTE 17: - CONTINGENT LIABILITIES AND COMMITMENTS
Kamada Ltd. and its subsidiaries
a.
On August 23, 2010, the Company entered into 30 years collaboration agreement with Baxter Healthcare Corporation ("Baxter"), an international biopharmaceutical company,
specializing, among other things, in the development, manufacture, marketing and sale of pharmaceutical products. During 2015, Baxter has assigned all its rights under the
collaboration agreement to Baxalta US Inc. ("Baxalta") which was acquired in 2016 by Shire plc (“Shire” and in these consolidated financial statements Baxter, Baxalta and Shire will
be referred to as "Shire"). The collaboration agreement consists of three main agreements (1) the appointment of Shire as the sole distributer of the Company's AAT IV drug
("Glassia") in the United States, Canada, Australia and New Zealand ("the Territory" and "the Distribution Agreement", respectively); (2) granting licenses to Shire for the use of the
Company's knowhow and patents for the production, continued development and sale of Glassia by Shire ("the License Agreement") in the Territory and (3) an agreement to provide
raw materials, produced by Shire, and used for the production of Glassia ("the Raw Materials Supply Agreement"). Pursuant to the agreements, payments were originally set for the
Company for meeting milestones at a total sum of $45 million, and for Glassia purchases at a minimum sum of $ 60 million over the first five years from the signing of the
Distribution Agreement. In addition, the Company is entitled to royalties at a sum of no less than $5 million per year, starting from the beginning of the sale of Glassia produced by
Shire in accordance with the License Agreement. Since 2013 and every year thereafter until 2016, the parties amended the License Agreement and the Distribution Agreement by
extending the distribution period of minimum purchases of Glassia and the minimum purchase quantity. Prior to the last amendment of the Distribution Agreement in October 2016,
the net sums received in advance were recorded as deferred revenues and were recognized as revenues according to the actual rate of sales, based on the sales forecast in the
Distribution Agreement. Commencing on the latest amendment of the Distribution Agreement in October 2016 the remaining deferred revenues are recognized on a straight line basis
according to Shire’s minimum purchase commitment in the Distribution Agreement for the remaining period prior to the recent amendment. According to the latest amendment of the
Distribution Agreement, the distribution period is currently expected to end by the end of 2020, with the start of production by Shire in 2021. Non-refundable revenues due to the
achievement of milestones are recognized upon reaching the milestone. As of December 31, 2017, the Company received a total of $39.5 million for the achievement of certain
milestones and advances in respect of the Distribution and License Agreements. As of December 31, 2017, a balance of $4.2 million is included as deferred revenues and is expected
to be recognized as revenues during 2018.
In the case of clinical trials required in the Territory in connection with Glassia, the cost of these experiments apply to Shire and the Company will participate with such limited extent
that may come, under certain conditions, up to $10 million over a period of several years.
According to the Raw Material Supply Agreement Shire undertook to provide the Company, free of charge, all the quantities of raw materials required by the Company for
manufacturing Glassia to be sold to Shire for distribution by Shire in accordance with the Distribution Agreement. The Company recorded the fair value of the raw material used and
sold as revenue and charged the same fair value to cost of revenue. In addition, Shire will provide raw material to the Company, for the development, production, sale and distribution
of products by the Company.
F - 38
Notes to the Consolidated Financial Statements
NOTE 17: - CONTINGENT LIABILITIES AND COMMITMENTS (CONT.)
Kamada Ltd. and its subsidiaries
b.
On August 2, 2012, the Company entered into a strategic agreement with CHIESI FARMACEUTICI S. P. A, a fully integrated European Pharmaceutical company focused on
respiratory disease and special care products ("Chiesi"). According to the agreement, Chiesi was an exclusive distributor of the AAT inhaled product of the Company for treatment of
alpha-1 antitrypsin deficiency ("Product") in Europe. As part of the Distribution Agreement, the Company was entitled to receive payments of up to $ 60 million, contingent of
meeting regulatory and sales milestones.
As of December 31, 2017, the Company had received a total of $9 million for the achievement of certain upfront payments in respect of the Distribution Agreement.
Due to the Company's decision in June 2017 to withdraw the Marketing Authorization Application (MAA) for this product with the European Medicines Agency (EMA), the
Company and CHIESI mutually agreed on November 14, 2017 to terminate the parties’ European distribution agreement related to Kamada’s inhaled Alpha-1 Antitrypsin (AAT)
therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). There are no financial implications related to the termination of this agreement.
c.
The Company has engaged in operating lease agreements for office and storage spaces. These agreements will expire in 2026.
Minimum future lease fees for the office and storage spaces as of December 31, 2017 are as follows:
Year 1
Year 2 to 5
Year 6 and thereafter
In thousands
$
$
590
2,479
2,541
5,610
d.
The Company has engaged in operating lease agreements for the vehicles in its possession. These agreements will expire between 2018 and 2020.
Minimum future lease fees for the existing vehicles as of December 31, 2017 are as follows:
Year 1
Year 2
Year 3
In thousands
$
$
443
284
95
822
F - 39
Notes to the Consolidated Financial Statements
NOTE 17: - CONTINGENT LIABILITIES AND COMMITMENTS (CONT.)
Kamada Ltd. and its subsidiaries
e.
f.
h.
In November 2006, an agreement was signed between the Company and a third party on the matter of research and development collaboration. As part of the agreement, the Company
was licensed to use developments made by the third party. Furthermore, the third party will provide the Company with devices for carrying out the clinical trials, free of charge. In the
event that the development is successful, the Company will pay the third party royalties based on sales of the devices. This obligation on behalf of the Company to pay royalties shall
expire either when the patents expire or 15 years from the first commercial sale, whichever comes last. On the date of the expiry of the royalty period, the license will become non-
exclusive and the Company shall be entitled to use the rights granted to it pursuant to the agreement without paying royalties or any other compensation. In addition, the third party
would pay royalties of the total net sales exceeding a certain sum, according to a mechanism set in the agreement, until the patent expires or until 15 years pass from the first date of
sale, whichever is earlier.
In February 2008, the parties signed an amendment to the agreement according to which the exclusive global license granted to the Company was expanded to two additional
indications. It was also decided that sales to the additional indications would be added to the sales of the first two outlines covered by the original agreement. Royalties' payments will
be according to the royalty model set in the original agreement.
In addition, the parties signed a commercialization and supply agreement, which ensures long-term regular supply of the device at the basis of the collaboration and spare parts of this
device.
In August 2007, the Company entered into a long-term agreement with a multinational European company for the purchase of a raw material used for the development and
manufacture of medicines at graded amounts and prices. In addition to the price paid by the Company for the raw material, the Company will pay the supplier an additional sum upon
the sale of the product manufactured from the raw material in the territories set in the agreement, after receiving regulatory approvals. As of December 31, 2017, the regulatory
approval was not yet received.
In July 2011, the Company signed a strategic collaboration agreement with an international pharmaceutical company in the area of clinical development, marketing and sales in the
United States of a post exposure prophylaxis product for the prevention of rabies in human beings. The product, KamRAB, is developed, manufactured and marketed by the Company
in other countries. The phase 3 clinical trial was completed in December 2014 had met the trial’s primary endpoint. The Company submitted a Biologics License Application (BLA)
with the U.S. Food and Drug Administration (FDA) in August 2016 and received the FDA approval for the product on August 2017.
In October 2016 the parties entered into an amendment to the agreement with respect to the conduct of clinical trial for pediatric treatment of Rabies in the United States which was
initiated on March 2017. The cost of the study is equally shared between the parties.
F - 40
Kamada Ltd. and its subsidiaries
Notes to the Consolidated Financial Statements
NOTE 18: - GUARANTEES AND CHARGES
1.
2.
In order to guarantee the rental payments for an office in Rehovot and other obligations, the Company provided a bank guarantees in the amount of $ 246 thousands.
As collateral for the Company’s original loans amount of NIS 8,355 thousands, the Company has pledged the specific assets which were purchased with those loans.
NOTE 19: - EQUITY
a.
share capital
ordinary shares of NIS 1 par value
70,000,000
40,262,819
70,000,000
36,419,842
On August 2, 2017 the Company closed a public offering on NASDAQ of 3,333,334 shares at $4.50 per share. As part of the offering, the underwriters received a right to purchase an
additional 500,000 ordinary shares to cover over-allotments at the same price per share. This option was fully exercise on August 30, 2017. The Company's total net proceeds from
the issuance of the above shares were $15.6 million
December 31, 2017
December 31, 2016
Authorized
Outstanding
Authorized
Outstanding
b.
Rights attached to Shares
Voting rights at the shareholders general meeting, rights to dividend, rights in case of liquidation of the Company and rights to nominate directors.
c.
Share options
During 2017 and 2016, 10,659 and 8,398 share options, respectively, were exercised into 1,988 and 1,101 ordinary shares of NIS 1 par value each for consideration of $3 thousand
and less than $1 thousands, respectively.
For additional information regarding options and restricted shares granted to employees and management in 2017, refer to Note 20 below.
d.
Capital management in the Company
The Company's goals in its capital management are to preserve capital ratios that will ensure stability and liquidity to support business activity and create maximum value for
shareholders.
F - 41
Notes to the Consolidated Financial Statements
NOTE 20: - SHARE-BASED PAYMENT
Kamada Ltd. and its subsidiaries
On July 24, 2011, the Company's Board of Directors approved a new unlisted Options Plan ("2011 Option Plan "). In September 2016 the Company's Board of Directors approved an
amendment to the plan and renamed it the Israeli Share Award Plan ("2011 Plan") to include restricted shares ("RS") awards (options and RS) that generally vest during a four-year
period following the date of the grant in 13 installments: 25% of the options vest on the first anniversary of the grant date and 6.25% options vest at the end of each quarter thereafter.
a.
Expense recognized in the financial statements
The share based payment expense that was recognized for services received from employees and directors is presented in the following table:
Cost of revenues
Research and development
Selling and marketing
General and administrative
Total share-based payment
b.
Option granted to the Company's Chief Executive Officer ("CEO")
2017
For the Year Ended
December 31
2016
In thousands
179
138
48
118
483
$
$
332 $
134
71
534
1,071 $
$
$
2015
564
390
98
855
1,907
On November 30, 2017, the Company’s general shareholders meeting approved the grant of 18,000 options and 6,000 RSs to Mr. Amir London, the Company’s CEO. The RSs do not
have exercise price. The options are exercisable into ordinary shares at an exercise price of NIS 21.99 per option. According to a calculation formula based on the binomial model, the
fair value of the options was estimated at $26 thousands. The fair value of the RSs was estimated based on the market price of the shares on the grant date at $28 thousands.
On August 30, 2016, the Company’s general shareholders meeting approved the grant of 18,000 options and 6,000 RSs to Mr. Amir London, the Company’s CEO. The RSs do not
have exercise price. The options are exercisable into ordinary shares at an exercise price of NIS 15.2 per option. According to a calculation formula based on the binomial model, the
fair value of the options was estimated at $41 thousands. The fair value of the RSs was estimated based on the market price of the shares on the grant date at $30 thousands.
c.
Employees options
1.
During 2017, 2016 and 2015 the Company's Board of Directors approved the grant, of 405,950, 320,775 and 356,075 options, respectively to employees and management. The
fair value of the options was estimated at $597 thousands, $548 thousands and $749 thousands, respectively.
F - 42
Notes to the Consolidated Financial Statements
NOTE 20: SHARE-BASED PAYMENT (CONT.)
Kamada Ltd. and its subsidiaries
2.
During 2017, the Company's Board of Directors approved the grant of 52,835 RSs to the Company’s employees and management. The RSs do not have exercise price. The
RSs are exercisable in 13 installments, 25% of the RSs vest on the first anniversary of the grant date and 6.25% vest at the end of each quarter thereafter into ordinary shares.
The fair value of the RSs was estimated based on the market price of the share on the grant date at $238 thousands.
d. Directors options
1.
2.
On November 30, 2017, the Company’s general shareholders meeting approved the grant of a total of 35,000 options to the Company’s board of directors. The options are
exercisable into ordinary shares at an exercise price of NIS 21.99 per option. According to a calculation formula based on the Binomial Model, the fair value of the options
was estimated at $51 thousands.
On August 30, 2016, the Company’s general shareholders meeting approved the grant of 50,000 options to the Company’s directors. The options are exercisable ordinary
shares at an exercise price of NIS 15.2 per option. According to a calculation formula based on the Binomial Model, the fair value of the options was estimated at $114
thousands.
f.
For additional information regarding the exercise of options during 2017, refer to Note 21.
Change of Awards during the Year
The following table lists the number of share options, the weighted average exercise prices of share options and modification in employee and service provider option plans during the
year:
2017
2016
2015
Number of
Options
Weighted
Average Exercise
Price
In NIS
Number of
Options
Weighted
Average Exercise
Price
In NIS
Number of
Options
Weighted
Average Exercise
Price
In NIS
Outstanding at beginning of year
Granted
Exercised
Forfeited
Outstanding at end of year
Exercisable at end of year
The weighted average remaining contractual life
for the share options
2,487,236
458,950
(10,659)
(363,155)
2,572,372
1,755,253
2,281,493
401,275
(8,398)
(187,134)
2,487,236
1,543,358
35.20
21.10
18.19
35.70
32.47
38.69
3.22
2,396,891
504,075
(430,178)
(189,295)
2,281,493
1,182,417
38.96
15.17
18.47
39.22
35.20
40.44
3.62
37.98
18.28
11.18
34.94
38.96
40.39
4.15
The range of exercise prices for share options outstanding as of December 31, 2016 and 2017 were NIS 15- NIS 57. Exercise is either by cash consideration of the exercise price or by
cashless method.
F - 43
Kamada Ltd. and its subsidiaries
Notes to the Consolidated Financial Statements
NOTE 20: SHARE-BASED PAYMENT (CONT.)
The following table lists the number of RSs and modification in employee RSs during the year:
Outstanding at beginning of year
Granted
End of restriction period
Forfeited
Outstanding at end of year
The weighted average remaining contractual life for the restricted share
Measurement of the fair value of equity-settled share options
Number of RSs
2017
2016
27,333
58,835
(7,656)
(2,000)
-
29,333
-
(2,000)
76,512
27,333
5.92
6.20
The Company uses the binomial model when estimating the grant date fair value of equity-settled share options. The measurement was made at the grant date of equity-settled share
options since the options were granted to employees.
The following table lists the inputs to the binomial model used for the fair value measurement of equity-settled share options for the above plan:
Dividend yield (%)
Expected volatility of the share prices (%)
Risk-free interest rate (%)
Contractual term of up to (years)
Exercise multiple
Weighted average share prices (NIS)
Expected average forfeiture rate (%)
NOTE 21: TAXES ON INCOME
a.
Tax laws applicable to the Company
Law for the Encouragement of Industry (Taxes), 1969
2017
-
37-45
0.1 – 1.83
6.5
2
16.05-16.44
1-5
2016
-
32-51
0.13 – 1.83
6.5
2
15.17
0-5
2015
-
42-64
0.07-2.04
6.5
2
17.17
0-5
The Law for the Encouragement of Industry (Taxes), 1969 (the “Encouragement of Industry Law”), provides several tax benefits for “Industrial Companies.” Pursuant to the
Encouragement of Industry Law, a company qualifies as an Industrial Company if it is a resident of Israel and at least 90% of its income in any tax year (exclusive of income from
certain defense loans) is generated from an “Industrial Enterprise” that it owns. An Industrial Enterprise is defined as an enterprise whose principal activity, in a given tax year, is
industrial activity.
F - 44
Notes to the Consolidated Financial Statements
NOTE 21: TAXES ON INCOME (CONT.)
Kamada Ltd. and its subsidiaries
An Industrial Company is entitled to certain tax benefits, including: (i) a deduction of the cost of purchases of patents, know-how and certain other intangible property rights (other
than goodwill) used for the development or promotion of the Industrial Enterprise in equal amounts over a period of eight years, beginning from the year in which such rights were
first used, (ii) the right to elect to file consolidated tax returns, under certain conditions, with additional Israeli Industrial Companies controlled by it, and (iii) the right to deduct
expenses related to public offerings in equal amounts over a period of three years beginning from the year of the offering.
Eligibility for benefits under the Encouragement of Industry Law is not contingent upon the approval of any governmental authority The Company believes that it currently qualifies
as an industrial company within the definition of the Industry Encouragement Law. The Company cannot assure that the Israeli tax authorities will agree that the Company qualifies,
or, if qualified, that it will continue to qualify as an industrial company or that the benefits described above will be available to the Company in the future.
Law for the Encouragement of Capital Investments, 1959
Tax benefits prior to Amendment 60
The Company's facilities in Israel have been granted Approved Enterprise status under the Law for the Encouragement of Capital Investments, 1959, commonly referred to as the
“Investment Law”. The Investment Law provides that capital investments in a production facility (or other eligible assets) may be designated as an Approved Enterprise. Until 2005,
the designation required advance approval from the Investment Center of the Israel Ministry of Industry, Trade and Labor. Each certificate of approval for an Approved Enterprise
("certificate of approval") relates to a specific investment program, delineated both by the financial scope of the investment and by the physical characteristics of the facility or the
asset.
Under the Approved Enterprise programs, a company is eligible for governmental grants (“Grants Track”). Under the Grants Track the Company is eligible for investments grants
awarded at various rates according to the development area in which the plant is located: in Development Zone A the rate is 24% and in Development Zone B the rate is 10%. In
addition to the above grants, the Company is eligible to tax exemption at the first two years of the benefit period (as define below) and is subject to reduced corporate tax of 10% to
25% during the remaining five to eight years (depending on the extent of foreign investment in the Company) of the benefit period. The benefits period is limited to 12 years from
completion of the investment or commencement of production ("Year of Operation"), or 14 years from the year in which the certificate of approval was obtained, whichever is earlier.
The benefit period for part of the Company plants has ended, or up to 2017.
Under the Investment Law a company may elect to receive an alternative package comprised of tax benefits (“Alternative Track”) instead of the above mentioned grants Track. Under
the Alternative Track, a company’s undistributed income derived from an Approved Enterprise is exempt from corporate tax for an initial period of two to ten years (depending on the
geographic location of the Approved Enterprise within Israel which begins in the first year that the Company realizes taxable income from the Approved Enterprise following the year
of operation (as define below). After expiration of the initial tax exemption period, the Company is eligible for a reduced corporate tax rate of 10% to 25% for the following five to
eight years, depending on the extent of foreign investment in the Company (as shown in the table below). The benefits period is limited to 12 years from the Year of Operation, or 14
years from the year in which the certificate of approval was obtained, whichever is earlier.
F - 45
Notes to the Consolidated Financial Statements
NOTE 21: TAXES ON INCOME (CONT.)
Tax benefits under Amendment 60
Kamada Ltd. and its subsidiaries
On April 1, 2005, an amendment to the Investment Law came into effect (“Amendment 60”). The amendment revised the criteria for investments qualified to receive tax benefits. An
eligible investment program under the amendment will qualify for benefits as a Privileged Enterprise (rather than the previous terminology of Approved Enterprise). Among other
things, the amendment simplifies the approval process.
In order to receive the tax benefits, the Amendment states that the company must make an investment in the Privileged Enterprise exceeding a certain percentage or a minimum
amount specified in the Investments Law. Such investment may be made over a period of no more than three years ending at the end of the year in which the company requested to
have the tax benefits apply to the Privileged Enterprise (the “Year of Election”).
The Company received a Tax Ruling from the Israeli Tax Authority that its activity is an industrial activity and the Company will be eligible for the status of a Privileged Enterprise,
provided that it meets the requirements under the ruling. The year of Election is 2009.The Company also obtained 2012 as a Year of election.
The duration of tax benefits is subject to a limitation of the earlier of 7 to 10 years (depending on the extent of foreign investment in the company) from the first year in which the
company generated taxable income (at, or after, the Year of Election) , or 12 years from the first day of the Year of Election. The amendment does not apply to investment programs
approved prior to December 31, 2004. The new tax regime applies to new investment programs only.
The tax benefits available under Approved Enterprise or Privileged Enterprise relate only to taxable income attributable to the specific Approved Enterprise or Privileged Enterprise,
and the Company's effective tax rate will be the result of a weighted combination of the applicable rates.
Tax Exemption
Period
2 years
2 years
2 years
2 years
2 years
Reduced Tax
Period
5 years
8 years
8 years
8 years
8 years
F - 46
Rate of
Reduced Tax
25%
25%
20%
15%
10%
Percent of
Foreign Ownership
0-25%
25-49%
49-74%
74-90%
90-100%
Notes to the Consolidated Financial Statements
NOTE 21: TAXES ON INCOME (CONT.)
Kamada Ltd. and its subsidiaries
The benefits available to an Approved Enterprise and a Privileged Enterprise are conditioned upon terms stipulated in the Investment Law and the related regulations and the criteria
set forth in the applicable certificate of approval (for an Approved Enterprise). If the Company does not fulfill these conditions, in whole or in part, the benefits can be cancelled and
we may be required to refund the amount of the benefits, linked to the Israeli consumer price index plus interest. The Company believes that its Approved Enterprise and Privileged
Enterprise programs currently operate in compliance with all applicable conditions and criteria.
If a company distributes dividends from tax-exempt income, the company will be taxed on the otherwise exempt income at the same reduced corporate tax rate that would have
applied to that income. Distribution of dividends derived from income that was taxed at reduced rates, but not tax-exempt, does not result in additional tax consequences to the
company. Shareholders who receive dividends derived from Approved Enterprise or Privileged Enterprise income are generally taxed at a rate of 15%, which is withheld and paid by
the company paying the dividend, if the dividend is distributed during the benefits period or within the following 12 years
(the limitation does not apply to a Foreign Investors Company, which is a company that more than 25% of its shares owned by non-Israeli residents).
Preferred Enterprise
Tax Benefits under the 2011 Amendment
As of January 1, 2011 new legislation amending to the Investment Law came into effect (the “2011 Amendment”). The 2011 Amendment introduced a new status of “Preferred
Company” and “Preferred Enterprise”, replacing the existed status of “Beneficiary Company” and “Beneficiary Enterprise”. Similarly to “Beneficiary Company”, a Preferred
Company is an industrial company owning a Preferred Enterprise which meets certain conditions (including a minimum threshold of 25% export). However, under this new
legislation the requirement for a minimum investment in productive assets was cancelled.
Under the 2011 Amendment, a uniform corporate tax rate will apply to all qualifying income of the Preferred Company, as opposed to the former law, which was limited to income
from the Approved Enterprises and Beneficiary Enterprise during the benefits period. The uniform corporate tax rate will be 12.5% elsewhere in Israel (in development area A - 7%).
On August 5, 2013, the "Knesset" issued the Law for Changing National Priorities (Legislative Amendments for Achieving Budget Targets for 2013 and 2014), which consists of
Amendment 71 to the Encouragement Law ("the Amendment"). According to the Amendment, the tax rate on preferred income from a preferred enterprise in 2014 and onwards will
be 16% (in development area A - 9%).
The Amendment also prescribes that any dividends distributed to individuals or foreign residents from the preferred enterprise's earnings as above will be subject to tax at a rate of
20% from 2014 and onwards (or a reduced rate under an applicable double tax treaty). Upon a distribution of a dividend to an Israeli company, no withholding tax is remitted.
F - 47
Notes to the Consolidated Financial Statements
NOTE 21: TAXES ON INCOME (CONT.)
Kamada Ltd. and its subsidiaries
In December 2016, the "Knesset" amended the Investment Law. According to the amendment, effective from January 1, 2017 the tax rate on:
1.
2.
3.
4.
Preferred income from a preferred enterprise will be 16% (in development area A – 7.5% instead of 9%).
Preferred income resulting from IP in a preferred technology enterprise will be 12% (in development area A – 7.5%).
Preferred income resulting from IP in a special preferred technology enterprise will be 6%.
Any dividends distributed from technology enterprise earnings to a foreign company that qualifies the provisions that are detailed in the law, will be subject to tax at a rate of
4%.
The Company has evaluated the effect of the adoption of the Amendment on its financial statements, and as of the date of the approval of the financial statements, the Company
believes that it will not apply the Amendment. Accordingly, the Company has not adjusted its deferred tax balances as of December 31, 2016. The Company may change its position
in the future.
b.
Tax rates applicable to the Company (other than the applicable preferred tax)
In January 2016, the Law for Amending the Income Tax Ordinance (No. 216) (Reduction of Corporate Tax Rate), 2016 was approved, which includes a reduction of the corporate tax
rate from 26.5% to 25%, effective from January 1, 2016.
In December 2016, the Israeli Parliament's Plenum approved, as part of the economic efficiency law (Legislative Amendments for Achieving Budget Targets for 2017 and 2018), a
reduction of the corporate tax rate in 2017 from 25% to 24%, and in 2018 from 25% to 23%.
c.
Tax assessments
1.
Finalized tax assessments
The Company has finalized its tax assessments through 2012.
2.
Settlement of tax assessments
On July 10, 2016, the Company and the Israel Tax Authority (ITA) entered into a settlement agreement for the tax years 2004-2006. As part of the agreement, the Company
paid NIS 5 million ($ 1.3 million) (including interest and CPI adjustment).
d.
Carry forward losses for tax purposes and other temporary differences
As of December 31, 2017, the Company has carry forward losses and other temporary differences in the amount of $ 90.1 million.
e.
Deferred taxes:
The Company did not recognize deferred tax assets for carry forward losses and other temporary differences, because their utilization in the foreseeable future is not probable.
F - 48
Notes to the Consolidated Financial Statements
NOTE 21: TAXES ON INCOME(CONT.)
f. Current taxes on income
Current taxes
Taxes in respect of prior years
g. Theoretical tax:
Kamada Ltd. and its subsidiaries
2017
Year ended December 31,
2016
In thousands
$
129
140
362 $
1,360
2015
269
$
1,722 $
-
-
-
$
$
The reconciliation between the statutory tax rate and the effective tax rate as recorded in profit or loss, does not provide significant information and therefore was not presented.
NOTE 22: - SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF PROFIT AND LOSS
a. Additional information about revenues
Revenues from major customers each of whom amount to 10% or more, of total revenues
Customer A – Proprietary products Segment
Customer B – Proprietary products Segment and Distribution Segment
Revenues based on the location of the customers, are as follows:
U.S.A.
Israel
Europe
Latin America
Asia
Others
F - 49
2017
Year Ended December 31,
2016
In thousands
2015
$
$
$
60,383
-
$
40,451
10,225
$
26,032
10,306
60,383
$
50,676
$
36,338
2017
Year Ended December 31,
2016
In thousands
2015
$
60,405
26,355
5,348
5,248
4,979
490
$
40,585
25,340
3,825
4,221
3,028
495
26,559
30,624
3,223
6,036
2,900
564
$
102,825
$
77,494
$
69,906
Notes to the Consolidated Financial Statements
NOTE 22: - SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF PROFIT AND LOSS (CONT.)
b. Cost of goods sold
Cost of materials
Salary and related expenses
Depreciation and amortization
Energy
Subcontractors
Other manufacturing expenses
Decrease (increase) in inventories
c. Research and development
Salary and related expenses
Subcontractors
Materials and allocation of facility costs
Others
d. Selling and marketing
Salary and related expenses
Marketing support
Packing, shipping and delivery
Marketing and advertising
Registration and marketing fees
Others
$
$
$
$
$
Kamada Ltd. and its subsidiaries
2017
Year Ended December 31,
2016
In thousands
2015
$
$
$
41,179
13,137
2,504
1,202
3,995
1,572
63,589
7,148
70,737
6,413
3,392
1,101
1,067
$
$
$
36,154
10,596
2,443
959
2,833
1,057
54,042
2,092
56,134
5,237
8,318
1,907
783
38,848
9,991
2,383
922
2,112
1,220
55,476
(935)
54,541
4,566
8,002
3,386
576
11,973
$
16,245
$
16,530
$
1,470
95
607
627
1,162
437
$
1,272
79
494
337
796
265
1,227
368
454
560
794
249
3,652
$
4,398
$
3,243
$
F - 50
Notes to the Consolidated Financial Statements
NOTE 22: - SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF PROFIT AND LOSS (CONT.)
e. General and administrative
Salary and related expenses
Employees welfare
Professional fees
Depreciation, amortization and impairment
Others
f. Financial incomes and expenses
Financial incomes
Interest income and gains from marketable securities
Financial expenses
Interest and amortization from debentures
Fees and interest paid to financial institutions
Others
Kamada Ltd. and its subsidiaries
2017
Year Ended December 31,
2016
In thousands
2015
$
$
$
$
$
3,138
2,182
1,497
649
807
8,273
$
$
3,029
1,465
1,378
712
769
7,353
$
$
500
$
469
$
-
162
-
162
$
$
-
126
-
126
$
$
2,604
1,391
1,482
524
606
6,607
463
731
111
92
934
NOTE 23: - INCOME (LOSS) PER SHARE
a.
Details of the number of shares and income (loss) used in the computation of income (loss) per share
2017
Weighted Number
of Shares
Income
Attributed to
equity holders of
the Company
For the computation of basic income (loss)
Effect of potential dilutive ordinary shares
37,970,697
74,400
$
For the computation of diluted income (loss)
38,045,097
$
6,901
-
6,901
F - 51
Year Ended December 31,
2016
2015
Weighted Number
of Shares
Loss Attributed
to equity holders
of the Company
Weighted
Number of
Shares
Loss Attributed
to equity holders
of the Company
In thousands
36,418,833
-
$
(6,733)
-
36,245,813
-
$
(11,270)
-
36,418,833
$
(6,733)
36,245,813
$
(11,270)
Notes to the Consolidated Financial Statements
NOTE 23: - INCOME (LOSS) PER SHARE (CONT.)
b.
The computation of the diluted income per share in 2017, did take into account the options and RSs due to their anti-dilutive effect.
NOTE 24: - OPERATING SEGMENTS
a.
General
Kamada Ltd. and its subsidiaries
The operating segments are identified on the basis of information that is reviewed by the chief operating decision maker ("CODM") to make decisions about resources to be allocated
and assess its performance. Accordingly, for management purposes, the Group is organized into operating segments based on the products and services of the business units and has
two operating segments as follows:
Proprietary Products
Develop and manufacture plasma-derived therapeutics and market them in more than 15 countries.
Distribution
Distribute imported drugs in Israel which are manufactured by third parties, most of which are produced from plasma or its derivative products.
Segment performance is evaluated based on revenues and gross profit in the financial statements.
The segment results reported to the CODM include items that are allocated directly to the segments and items that can be allocated on a reasonable basis. Items that were not
allocated, mainly the Group's headquarter assets, general and administrative costs and financial costs (consisting of finance expenses and finance income and including fair value
adjustments of financial instruments), are managed on a group basis.
The segment liabilities do not include loans and financial liabilities as these liabilities are managed on a group basis.
b. Reporting on operating segments
Year Ended December 31, 2017
Revenues
Gross profit
Unallocated corporate expenses
Finance expense, net
Income before taxes on income
F - 52
Proprietary
Products
Distribution
In thousands
Total
$
$
79,559
$
23,266 $
102,825
28,224
$
3,864 $
32,088
(24,644)
(274)
$
7,170
Notes to the Consolidated Financial Statements
NOTE 24: - OPERATING SEGMENTS (CONT.)
Year Ended December 31, 2016
Revenues
Gross profit
Unallocated corporate expenses
Finance income, net
Loss before taxes on income
Year Ended December 31, 2015
Revenues
Gross profit
Unallocated corporate expenses
Finance income, net
Loss before taxes on income
NOTE 25: - BALANCES AND TRANSACTIONS WITH RELATED PARTIES
a.
Balances with related parties
December 31, 2017
Other accounts payables
Employee benefit liabilities, net
Trade receivable
F - 53
Kamada Ltd. and its subsidiaries
$
$
$
$
Proprietary
Products
Distribution
In thousands
Total
55,958
$
21,536 $
77,494
18,235
$
3,125 $
21,360
(26,841)
470
$
(5,011)
Proprietary
Products
Distribution
In thousands
Total
42,952
$
26,954
$
69,906
12,051
$
3,314
$
15,365
(26,789)
154
$
(11,270)
December 31,
2017
December 31,
2016
In thousands
$
$
$
292
92
2,382
$
$
$
230
170
675
Notes to the Consolidated Financial Statements
NOTE 25: - BALANCES AND TRANSACTIONS WITH RELATED PARTIES (CONT.)
b.
Benefits to related parties
Salary and related expenses to those employed by the Company or on its behalf
Salary of directors not employed by the Company or on its behalf
Number of People to whom the Salary and Benefits Refer
Related and related parties employed by the Company or on its behalf
Directors not employed by the Company
c.
Benefits to key executive personnel (including non-related parties)
Short-term benefits
Share-based payment
Other long-term benefits
d.
Transactions with related parties
Sales
Selling and marketing expenses
General and administrative expenses
F - 54
Kamada Ltd. and its subsidiaries
Year Ended December 31,
2016
2017
In thousands
$
$
460
$
107
$
2
2
4
473
122
2
3
5
2017
Year Ended December 31,
2016
In thousands
2015
$
$
2,719
310
6
2,453 $
460
28
$
3,035
$
2,941 $
2,144
650
61
2,855
2017
Year Ended December 31,
2016
In thousands
2015
$
$
$
3,455
$
121
$
446
$
2,230 $
101 $
503 $
2,795
114
526
Notes to the Consolidated Financial Statements
NOTE 25: - BALANCES AND TRANSACTIONS WITH RELATED PARTIES (CONT.)
e.
Revenues and Expenses from Related and Interested Parties
Terms of Transactions with Related Parties
Kamada Ltd. and its subsidiaries
1.
2.
Sales to related parties are conducted at market prices. Balances that have yet to be repaid by the end of the year are not guaranteed, bear no interest and their settlement will be
in cash. No guarantees were received or given for sums receivable or payable. For the years ended December 31, 2017, 2016 and 2015, the Company recorded no allowance
for doubtful accounts for sums receivable from related parties.
On May 26, 2011, the Company announced its engagement in an amended agreement regarding the distribution of Glassia, that revises and replaces the distribution agreement
signed in 2001 between the Company and Tuteur SACIFIA ("Tuteur"), a company registered in Argentina, currently under the control of the Hahn family. The amendment to
the agreement was made as an arm’s length transaction.
On August 19, 2014 the Company amended the agreement in order to add KamRho(D) as an additional product to be distributed by Tuteur and expanded the territory to
include Bolivia.
Pursuant to the distribution agreement, Tuteur serves as the exclusive distributor of Glassia and KamRho(D), in Argentina, Paraguay and Bolivia. In 2016 the board of
directors approved to provide Tuteur reimbursement at a non-material amount to be used for marketing activities aimed to locating new AATD patients and increasing the
overall number of AATD patients treated with Glassia in Argentina. Such reimbursement will be granted until the end of September 2019. In 2016 and 2017 a reimbursement
was paid according to the agreement. In addition, in 2016 and in 2017 the board of directors also approved to grant Tuteur an arm’s length discount for KamRho(D) at a non-
material amount.
3.
Mr. Reuven Behar, a partner of Fischer Behar Chen Well Orion Co., the Company’s external legal counsel was a director in the Company until May 2016. Fees attributed to
Fischer Behar Chen Well Orion Co. are included in the tables above for the period ending May 1, 2016.
On July 29, 2015 the Company’s Board of Directors approved to engage Khairi S.A. (“Khairi”), a company that is held, inter alia, by Mr. Leon Recanati, the Chairman of the
Company's board of directors, Mr. Jonathan Hahn, a director in the company and his siblings and Mr. Reuven Behar, a former director in the Company, who serves as the
chairman of the board of directors of Khairi, in a distribution agreement, for the distribution of Glassia and KamRho(D) in Uruguay. This distribution agreement with Khairi is
an arm’s length transaction.
F - 55
Notes to the Consolidated Financial Statements
NOTE 25: - BALANCES AND TRANSACTIONS WITH RELATED PARTIES (CONT.)
f.
Chief executive officer employment terms
Kamada Ltd. and its subsidiaries
On June 30, 2015 the Company’s shareholders approved the employment terms of Mr. Amir London in his position as the Company’s chief executive officer (“CEO”), effective as of
July 1, 2015. Under the employment agreement, Mr. Amir London is entitled to a monthly gross salary of NIS 65,000 (or $16,658). On August 30, 2016 the general meeting of the
shareholders approved the update of Mr. London’s monthly gross salary to NIS 71,500 (or $18,430), effective as of July, 1 2016. During 2017 the Company recorded approximately
$127 thousands, as a bonus to Mr. London. As for the grant of options and restricted shares to Mr. London, refer to Note 20b.
F - 56
TERMINATION AGREEMENT
Exhibit 4.29
This Termination Agreement (this “Termination Agreement”) dated as of November 14th, 2017 (the “Effective Date”), is made by and between Kamada Ltd. (“Kamada”), and Chiesi
Farmaceutici S.p.A. (“Chiesi”) (Kamada and Chiesi are jointly referred to herein as the “Parties”).
RECITALS
WHEREAS, on August 2nd, 2012, the Parties have entered into that certain Exclusive Distribution Agreement, according to which: (a) Kamada was responsible, inter alia, for the development and
receiving approval of the Marketing Authorization Application ("MAA") from the European Medicines Agency ("EMA") for its inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1
Antitrypsin Deficiency (the "Product"); and (b) Chiesi was responsible, inter alia, upon receiving approval of the MAA from the EMA, for obtaining reimbursement and distribution of the Product in
Europe (the “Distribution Agreement”); and
WHEREAS, the Distribution Agreement was subsequently amended by a first amendment thereto dated November 19, 2015 (the “First Amendment”) and a second amendment thereto dated
September 1, 2016 (the “Second Amendment”); and
WHEREAS, on April 12, 2017, the Parties have also entered into that certain Safety Data Exchange Agreement and Medical Enquires Handling to define their respective pharmacovigilance
responsibilities (the “SDEA”); and
WHEREAS, following extensive discussions with the EMA, Kamada concluded that the EMA does not view the data submitted to it as sufficient for approval of the MAA, and that the
supplementary data needed for such approval requires an additional clinical trial and accordingly decided to withdraw the MAA; and
WHEREAS, based on the MAA withdrawal and the anticipated timelines for potentially resubmitting the MAA, the Parties mutually decided to terminate the Distribution Agreement.
NOW THEREFORE, in consideration of the mutual promises and obligations contained in this Termination Agreement, the Parties hereby agree as follows:
1. All terms used in this Termination Agreement shall have the same meanings ascribed to them in the Distribution Agreement, unless otherwise explicitly indicated herein.
2.
Immediately upon the Effective Date, the Distribution Agreement, the First Amendment, the Second Amendment and the SDEA shall terminate in their entirety and consequently, all rights and
obligations of either Party thereunder shall be terminated (including, for the avoidance of doubt, all rights and obligations related to the Commercialization Agreement) and, except for the Parties'
undertakings under Sections 6.9 (Trademarks), 13.1 (Kamada Indemnity), 13.2 (Chiesi Indemnity), 13.3 (Claims for Indemnification), 13.4 (Third-Party Claims) and 13.6 (Limitation on
Liability) and Articles 12 (Confidential Information), 15 (Notices) and 16 (Miscellaneous), other than Section 16.13, of the Distribution Agreement, neither Party shall have any right or
obligation towards the other Party related to the Distribution Agreement, the First Amendment, the Second Amendment and the SDEA.
3. Both Parties agree that they shall not be entitled to receive any compensation from the other Party or anyone acting on its behalf, in any manner whatsoever, as a result of or in connection with, or
derived from the Distribution Agreement, the First Amendment, the Second Amendment and the SDEA or the termination thereof, and either Party, effective as of the Effective Date,on behalf of
itself and each of its agents, principals, officers, directors, employees, stockholders, partners, parents, subsidiaries, affiliates, predecessors, successors, representatives, and assigns, fully, finally
and forever releases relinquishes and discharges the other Party and any acquirer or assignee of the other Party's assets and their respective past, present or future officers, directors, shareholders,
joint venturers, affiliates, members, partners, partnerships, principals, parent companies, subsidiaries, representatives, employees, servants, and agents, in their capacities as such, of and from any
and all charges, complaints, claims, liabilities, obligations, promises, agreements, controversies, damages or causes of action, suits, rights, demands, costs, losses, debts and expenses (including
attorneys' fees and costs incurred) of any nature whatsoever, in law or in equity, whether known or unknown, anticipated or unanticipated, and whether accrued or hereafter to accrue that they
now have, may have, or could have from the beginning of time to the Effective Date that in any way arises out of, are connected with, or that are in any way related to, the Distribution
Agreement, the First Amendment, the Second Amendment and the SDEA, excluding only claims for breach of this Termination Agreement and the provisions, rights and obligations of the
Parties that expressly survive the Effective Date as set forth in this Termination Agreement.
4. This Termination Agreement constitutes the entire understanding and agreement between the Parties hereto and supersedes any and all prior discussions, agreements and correspondences with
regard to the Distribution Agreement, the First Amendment, the Second Amendment and the SDEA.
5. Subject to paragraph 6 of this Termination Agreement, neither Party may issue any announcement, press release or make any such other public statement, in each case, with respect to or in
connection with this Termination Agreement, without consent of the other Party. The Parties shall consult together on the timing, contents and manner of release of any such announcement, press
release or public statement.
6. The Parties agree to make an announcement with respect to this Termination Agreement, in the form set out in the Appendix, within two (2) Business Days of the Effective Date (the
“Announcement”). Thereafter, each Party may, without consultation or consent from the other Party, make any public statement in response to questions from the press, research analysts,
investors or those attending industry conferences, make internal announcements to employees and make disclosures in documents filed with any stock exchange authority, so long as such
statements, announcements and disclosures substantially reiterate the Announcement or the information within it, and are not inconsistent with the Announcement.
Kamada – Chiesi – Termination Agreement
Page 2
[signature page follows]
IN WITNESS WHEREOF, the Parties hereto have caused this Termination Agreement to be executed by their duly authorized respective officers as of the Effective Date.
Kamada Ltd.
By:
By:
_________________________
Amir London
CEO
_________________________
Gil Efron
Deputy CEO & CFO
Kamada – Chiesi – Termination Agreement
Chiesi Farmaceutici S.p.A.
By:
By:
_________________________
Alberto Chiesi
President
_________________________
Ugo Di Francesco
CEO
Page 3
Kamada – Chiesi – Termination Agreement
Page 4
APPENDIX
Our significant subsidiaries are set forth below, all of which are either 100% owned by us or controlled by us.
SIGNIFICANT SUBSIDIARIES
Legal Name
Kamada Biopharma Limited
Kamada Inc.
Bio-Kam Ltd.
Kamada Assets Ltd.
Jurisdiction
England and Wales
Delaware
Israel
Israel
Exhibit 8.1
Exhibit 12.1
I, Amir London, certify that:
1.
I have reviewed this annual report on Form 20-F of Kamada Ltd.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and
cash flows of the company as of, and for, the periods presented in this report;
4. The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to
the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or
is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5. The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of
the company’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s
ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
Date: March 5, 2018
/s/ Amir London
Amir London
Chief Executive Officer
I, Chaime Orlev, certify that:
1.
I have reviewed this annual report on Form 20-F of Kamada Ltd.;
Exhibit 12.2
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and
cash flows of the company as of, and for, the periods presented in this report;
4. The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to
the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or
is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5. The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of
the company’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s
ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.
Date: March 5, 2018
/s/ Chaime Orlev
Chaime Orlev
Chief Financial Officer
CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER PURSUANT
TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE
SARBANES-OXLEY ACT OF 2002
Exhibit 13.1
In connection with the Annual Report of Kamada Ltd. (the “Company”) on Form 20-F for the period ended December 31, 2017 as filed with the Securities and Exchange Commission (the
“Report”), I, Amir London, Chief Executive Officer of the Company, hereby certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1)
the Report fully complies with the requirements of section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934; and
(2)
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: March 5, 2018
/s/ Amir London
Amir London
Chief Executive Officer
In connection with the Annual Report of Kamada Ltd. (the “Company”) on Form 20-F for the period ended December 31, 2017 as filed with the Securities and Exchange Commission (the
“Report”), I, Chaime Orlev, Chief Financial Officer of the Company, hereby certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1)
the Report fully complies with the requirements of section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934; and
(2)
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: March 5, 2018
/s/ Chaime Orlev
Chaime Orlev
Chief Financial Officer
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Exhibit 15.1
We consent to the incorporation by reference in the Registration Statements on Form S-8 (File Nos 333-192720, 333-207933, 333-215983 and 333-222891) and in Registration Statement on
Form F-3 (File No. 333-214816) of Kamada Ltd. (the “Company”) of our report dated March 6, 2018, with respect to the Company's consolidated financial statements for the year ended December 31,
2017 included in this Annual Report on Form 20-F for the year ended December 31, 2017.
Tel Aviv, Israel
March 6, 2018
/s/ KOST, FORER, GABBAY & KASIERER
KOST, FORER, GABBAY & KASIERER
A member of Ernst & Young Global