UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
[X]
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2019
OR
[ ]
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM ______ TO
Commission File Number 001-38738
ETON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction
of incorporation or organization)
21925 W. Field Parkway, Suite 235
Deer Park, IL
(Address of principal executive offices)
37-1858472
(I.R.S. Employer
Identification No.)
60010-7208
(Zip Code)
Registrant’s telephone number, including area code: (847) 787-7361
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, $0.001 par value
Trading Symbol
ETON
Name of each exchange on which registered
The Nasdaq Global Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES [ ] NO [X]
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES [ ] NO [X]
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 [X] NO [ ]
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files).
YES [X] NO [ ]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or
an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth
company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Non-accelerated filer
[ ]
[ ]
Accelerated filer
Smaller reporting company
Emerging growth company
[X]
[X]
[X]
If an emerging growth company, 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. [X]
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES [ ] NO [X]
The aggregate market value of all common stock (based upon the closing price on the Nasdaq Global Market) of the registrant held by non-affiliates
as of June 30, 2019 was approximately $96.6 million.
As of February 28, 2020 the registrant had 17,882,486 shares of common stock, $0.001 par value per share, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive proxy statement for its 2020 Annual Meeting of Stockholders, which the registrant intends to file pursuant to
Regulation 14A with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year ended December 31, 2019, are
incorporated by reference into Part III of this Annual Report on Form 10-K.
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
TABLE OF CONTENTS
PART I
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Schedule II – Valuation and Qualifying Accounts
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accountant Fees and Services
PART III
Item 15.
Exhibits, Financial Statement Schedules
Signatures
PART IV
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Note Regarding Forward-Looking Statements
This Annual Report on Form 10-K and the information incorporated herein by reference contain forward-looking statements that involve a number
of risks and uncertainties, many of which are beyond our control. Although our forward-looking statements reflect the good faith judgment of our
management, these statements can only be based on facts and factors currently known by us. Consequently, these forward-looking statements are inherently
subject to risks and uncertainties, and actual results and outcomes may differ materially from results and outcomes discussed in the forward-looking
statements as a result of various factors, including those set forth below under the caption “Risk Factors.”
Forward-looking statements in this Annual Report and in our other reports with the Securities and Exchange Commission (the “SEC”), for example,
may include statements regarding:
● our future financial and operating results;
● our intentions, expectations and beliefs regarding anticipated growth, market penetration and trends in our business;
● the timing and success of our plan of commercialization;
● our ability to successfully develop and clinically test our product candidates;
● our ability to submit of our product candidates through the 505(b)(2) regulatory pathway for approval by the U.S. Food and Drug
Administration (the “FDA”);
● our ability to obtain FDA approval for any of our product candidates;
● our ability to comply with all U.S. and foreign regulations concerning the development, manufacture and sale of our product candidates;
● the adequacy of the net proceeds from our initial public offering;
● the effects of market conditions on our stock price and operating results;
● our ability to maintain, protect and enhance our intellectual property;
● the effects of increased competition in our market and our ability to compete effectively;
● costs associated with initiating and defending intellectual property infringement and other claims;
● the attraction and retention of qualified employees and key personnel;
● our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act;
● future acquisitions of or investments in complementary companies or technologies; and
● our ability to comply with evolving legal standards and regulations, particularly concerning requirements for being a public company.
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In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “continue,” “could,” “estimates,”
“expects,” “hopes,” “intends,” “may,” “plan,” “potential,” “predicts,” “projects,” “seeks,” “should,” “will,” “would” or the negative of those terms, and
similar expressions that convey uncertainty of future events or outcomes. In addition, statements that “we believe” and similar statements reflect our beliefs
and opinions on the relevant subject. These statements include, but are not limited to, statements under the captions “Business,” “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as other sections in this report. We discuss many of the
risks associated with the forward-looking statements in this Annual Report on Form 10-K in greater detail under the heading “Risk Factors.” Moreover, we
operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all
risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking statements we may make. You should be aware that the occurrence of any of the events
discussed under the caption “Risk Factors” and elsewhere in this report could substantially harm our business, results of operations and financial condition
and that if any of these events occurs, the trading price of our common stock could decline and you could lose all or a part of the value of your shares of our
common stock .
The cautionary statements made in this report are intended to be applicable to all related forward-looking statements wherever they may appear in
this Annual Report on Form 10-K. We urge you not to place undue reliance on these forward-looking statements, which speak only as of the date of this
Annual Report on Form 10-K. For all forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the
Private Securities Litigation Reform Act of 1995. Except as required by law, we assume no obligation to update our forward-looking statements publicly, or to
update the reasons actual results could differ materially from those anticipated in any forward-looking statements, whether as a result of new information,
future events or otherwise.
This Annual Report on Form 10-K also contains estimates, projections and other information concerning our industry, our business, and the markets
for our product candidates, as well as data regarding market research, estimates and forecasts prepared by our management. Information that is based on
estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may
differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market
and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and
general publications, government data and similar sources. As used in this Annual Report on Form 10-K, unless the context indicates or otherwise requires,
“Eton,” “our company,” “we,” “us,” and “our” refer to Eton Pharmaceuticals, Inc., a Delaware corporation.
You should read the following together with the more detailed information regarding our company, our common stock and our financial statements
and notes to those statements appearing elsewhere in this report or incorporated by reference. The SEC allows us to “incorporate by reference” information
that we file with the SEC, which means that we can disclose important information to you by referring you to those documents. The information incorporated
by reference is considered to be part of this report.
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Item 1. Business
Overview
PART I
We were formed in April 2017 as a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative
pharmaceutical products that fulfill an unmet patient need. We have successfully built a diversified portfolio of high-value pharmaceutical products, primarily
focused on two categories: hospital injectable products and pediatric retail prescription products.
Corporate Strategy
We plan to achieve our goal of becoming an industry leading innovative pharmaceutical company by executing on the commercialization of
Biorphen® and continuing to build our product portfolio through internal product development and business development activities. Our business
development activities primarily target product opportunities with the following characteristics:
Short Time to Market. We seek out innovative products that are FDA approved, under review with the FDA, or have the potential to be commercialized
within 18 months.
Protection from Competition. Product protection typically takes the form of Orange Book listed patents and FDA granted exclusivities, such as orphan
drug exclusivity. Protection can also include challenging to replicate formulations, complex manufacturing, or difficult to source active pharmaceutical
ingredients.
Low Clinical and Regulatory Risk. We pursue product candidates where we can leverage existing safety and efficacy data to reduce the clinical burden
required to receive FDA approval, providing for faster and lower cost product approvals. Typically, our products require only a single Phase 3 trial, a
bioequivalence trial, or literature based clinical data for their New Drug Application (“NDA”) submissions.
Low Commercial Risk. We pursue products that we believe can fulfill a proven unmet need. This may include opportunities to bring products to market
to address markets that are currently relying on unapproved or compounded products.
Product Portfolio
Our currently disclosed product portfolio includes nine products: one commercial product, three products under review with the FDA, and five
candidates in our late-stage pipeline.
Product (Molecule)
Biorphen (Phenylephrine)
EM-100 (Ketotifen)
ET-105 (Lamotrigine)
DS-300
ET-104
ET-103 (Levothyroxine)
ET-203
DS-100
ET-101
Dosage Form
Injectable
Ophthalmic
Oral Liquid
Injectable
Oral Liquid
Oral Liquid
Injectable
Injectable
Oral Liquid
Category
Hospital
OTC**
Pediatric
Hospital
Pediatric
Pediatric
Hospital
Hospital
Pediatric
Expected Submission
Timing
Approved
Submitted
Submitted
Submitted
2020
2020
2020
2020
2020
Reference Product
Market Size
$45 million+
$50 million +
$700 million +
$60 million* +
$65 million +
$2.5 billion +
$70 million +
$100 million* +
$800 million +
Note: Pipeline only includes product candidates that Eton expects to submit within twelve months.
Reference product market sizes based on IQVIA data unless noted.
*Based on management estimates
**Product will be marketed by Bausch Health
Approved Products
Biorphen (Phenylephrine Hydrochloride Injection). Biorphen is the first and only FDA-approved formulation of ready-to-use phenylephrine
injection. Biorphen in indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. The
product was approved in October 2019 and launched in December 2019.
We estimate the current market size for ready-to-use phenylephrine to be more than 20 million units of Biorphen annually. Biorphen primarily
competes with FDA-approved formulations of concentrated phenylephrine injection, which must be diluted prior to administration to patients, and with
unapproved formulations of ready-to-use phenylephrine sold by 503B compounding pharmacies. We acquired U.S. marketing rights to the product from
Sintetica SA (“Sintetica”) in February 2019.
Products Under FDA Review:
ET-105 (Lamotrigine for Oral Suspension). ET-105 is our innovative formulation of lamotrigine to be delivered to patients as an oral suspension.
The NDA for ET-105 has been submitted to the FDA and is under review for the treatment of partial on-set seizures, primary generalized tonic-clonic
seizures, and seizures of Lennox-Gastaut syndrome in patients two year of age and older.
ET-105 is designed to fulfill an unmet need for patients that require precision dosing or have challenges administering oral solid formulations. Due to
Lamotrigine’s weight-based dosing calculation and the required titration dosing upon initiation of treatment, we believe there is a significant need for ET-
105’s precision dosing. Currently the lowest strength tablet form of lamotrigine that is widely available is a 5mg tablet. ET-105 is designed to allow dosing in
increments of 1.0mg.
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Lamotrigine is currently only approved in oral solid formulations, for which the U.S. market is currently more than $700 million annually according
to IQVIA data. We acquired U.S marketing rights to the product from Aucta Pharmaceuticals in June 2019. Aucta has been issued a patent on ET-105’s
innovative formula, which we expect to be listed in the FDA’s Orange Book upon approval. ET-105’s NDA is under review with the FDA. The application
has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 17, 2020, however, on February 19, 2020 we disclosed that we
received an FDA request for changes to the Dosage and Administration section of the product’s Prescribing Information to simplify the dosing information
for intended users. The FDA has requested that the company conduct a human factors validation study with the revised labeling to demonstrate that the
intended users can prepare and administer the oral suspension safely and effectively. The company expects the study and its final report to be completed and
submitted to the FDA in 2020.
EM-100 (Ketotifen Ophthalmic Solution). EM-100 is a preservative-free formulation of ketotifen ophthalmic solution for the treatment allergic
conjunctivitis. The product is expected to be the first and only preservative-free ophthalmic product approved for the treatment of allergic conjunctivitis. EM-
100’s preservative-free formulation is designed to deliver an improved comfort profile to patients compared to currently available ketotifen ophthalmic
products that contain preservatives. EM-100 will be sold via the over-the-counter (OTC) channel. Currently the market for ketotifen ophthalmic products is
estimated to be more than $75 million annually based on data from IRI and IQVIA.
We sold the EM-100 product rights to Bausch Health (“Bausch”) in February 2019. Bausch Health will be responsible for commercialization of the
product. We are entitled to receive a $1.5 million milestone payment upon launch of the product and will receive a double-digit percentage royalty on the
product’s net sales. Bausch received a Complete Response Letter on the product’s application in July 2019 and responded in an amendment submitted in
December 2019. The product has been assigned a target action date in August 2020.
DS-300. DS-300 is an injectable product candidate for which we have submitted an Abbreviated New Drug Application “ANDA” to the FDA. We
originally submitted DS-300 as an NDA under a Rolling Review, however, due to the approval of a competitor’s NDA containing the same active ingredient,
the FDA requested that we resubmit the product as an ANDA. The ANDA was submitted in December 2019 and has been accepted for review by the FDA.
We believe we are the first-to-file ANDA and should be entitled to 180 days of exclusivity if the patent is successfully challenged. The FDA has assigned the
product’s application a target action date in October 2020, however, expected Paragraph IV challenge litigation will delay final FDA approval beyond that
date.
Prior to the approval of the reference product by a third party in 2019, DS-300’s active ingredient was supplied in injectable form as an unapproved
product. Based on the IQVIA date for the current market price and historic volumes for the unapproved product, we believe the market size is more than $65
million annually.
Late-Stage Product Candidates
ET-203. ET-203 is an innovative ready-to-use formulation of a molecule that is currently approved in a concentrated formulation that must be diluted
prior to administration to patients. Hospitals currently purchase non-FDA approved ready-to-use products from compounding facilities, or manually dilute the
products in-house. Our product candidate has been developed in a ready-to-use strength that can be immediately administered to patients, eliminating the need
for calculations and additional dilution steps. We believe that, if approved, ET-203 will offer significant benefits to hospitals over the current compounded
products, including longer shelf-life, reduction of compounding errors, greater sterility assurance, and more consistent supply. ET-203’s NDA was originally
submitted to the FDA in July 2019 and received a refuse-to-file letter. Our development partner, Sintetica, expects to address the FDA’s concerns and
resubmit the NDA in 2020.
ET-104. ET-104 is an innovative oral liquid product candidate targeting a neurological indication. ET-104’s active ingredient is approved and
marketed in an oral solid formulation, but the active ingredient is not approved by the FDA in liquid form. Currently, patients requiring liquid formulations of
the active ingredient are reliant on compounded products or manually crushing tablets to create liquid solutions. ET-104 is expected to address this significant
unmet patient need. Our development partner filed a patent application on its unique formula in March 2019. We are currently in discussions with the FDA
regarding the application’s pediatric study protocol, and we expect to submit the NDA in 2020. The current market for ET-104’s active ingredient in oral solid
form is more than $65 million annually according to IQVIA.
ET-103. ET-103 is a unique oral liquid formulation of levothyroxine for the treatment of hypothyroidism. Currently levothyroxine is delivered
primarily in tablet and capsule form and is one of the most frequently prescribed medications in the United States with more than 5.7 billion tablets and $2.6
billion prescribed annually according to IQVIA data. We are currently in discussions with the FDA regarding the products bioequivalence data results to
ensure compliance with FDA requirements prior to submission of the NDA. If we receive agreement from the FDA, we expect the product’s NDA to be
submitted in the first half of 2020.
DS-100. DS-100 is an injectable product candidate. DS-100’s active ingredient was historically sold in injectable form as an unapproved product, but
a third party recently received FDA approval. Eton is pursuing a different indication than the currently approved product. We expect an NDA for DS-100 to
be submitted in 2020.
ET-101. Is an innovative oral liquid product candidate targeting a neurological condition. ET-101’s active ingredient is approved and marketed in an
oral solid formulation, but the active ingredient is not approved by the FDA in liquid form. Currently, patients requiring liquid formulations of the active
ingredient are reliant on compounded products. ET-101 is expected to address this significant unmet patient need. Based on IQVIA data, the U.S. market for
ET-101’s active ingredient in oral solid form is more than $800 million annually. We are currently running a bioequivalence study for the product and expect
to file the NDA in 2020.
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Our late-stage pipeline only includes product candidates that we believe can be submitted to the FDA within twelve-months. For competitive
reasons, we typically do not disclose our additional product candidates that are more than twelve months away from NDA submission.
Goals and Strengths
Our goal is to become a leading specialty pharmaceutical company through the introduction of innovative medicines that are affordable and available
to all patients. We believe our competitive strengths include our:
● unique knowledge of the industry, including our ability to identify product opportunities;
● management’s regulatory and development experience, particularly within the 505(b)(2) pathway;
● our portfolio of attractive assets that we believe will enable us to compete effectively in the market;
● management’s experience in business development, M&A, licensing activities and broad industry connections;
● differentiated business model as compared to generic and branded specialty pharmaceutical drug companies, utilizing the 505(b)(2) pathway;
and
● patent rights, know-how, exclusive API and manufacturing relationships.
Sales and Marketing
We currently commercialize Biorphen with the support of a co-promotion agreement with Xellia Pharmaceuticals. We intend to commercialize most
of our products through our internal sales and marketing infrastructure. However, in certain scenarios we may conclude that it is financially or strategically
beneficial to out-license, sell, or partner with a third party for commercialization of a product. For example, we sold our EM-100 product candidate to Bausch
Health, who has an established presence in the over-the-counter ophthalmic channel, in exchange for milestone payments and future royalty payments based
on Bausch’s sales of the product.
Our products primarily fall into two categories for commercialization: Hospital injectables and retail prescription products.
Hospital injectables products are primarily marketed to hospitals and surgical centers and may be purchased by customers through wholesalers
and/or arrangements with Group Purchasing Organizations (GPOs). Our first product launch in this category was Biorphen in December 2019, and our
additional hospital injectable products include DS-300, ET-203, and DS-100.
In January 2020 we signed a co-promotion agreement with Xellia for the promotion of Biorphen. Under terms of the agreement, Xellia’s US-based
hospital sales force will promote Biorphen in certain customer channels in collaboration with Eton, in exchange for a commission based on net sales realized
at certain customer accounts. The product will continue to be sold under Eton’s brand name, and Eton has the right to continue promoting the product to all
customer accounts. The agreement has a five-year term, but allows Eton to exit under various scenarios, including a change of control, and after 2021 if
Biorphen net sales from Xellia designated accounts do not exceed $29.4 million in 2021, or $42.0 million in 2022 and the following years.
Our retail prescription products will be promoted to prescribing physicians, primarily neurologists and endocrinologists. We intend to distribute the
products through a network of retail and specialty pharmacies. Our products in this category include ET-105, ET-104, ET-103 and ET-101.
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Research and Development
We currently have ten employees that support research and development and have a laboratory facility that supports product development and
testing. In addition, we utilize external sources for various product development activities including the resources of our product development partners for
certain product candidates and also through the use of contract laboratory services on a fee for service model.
Manufacturing and Suppliers
We rely on third party contract manufacturing organizations (“CMOs”) to manufacture our products. All our manufacturing partners are based in the
United States or Europe. We seek to work with CMOs that have a long history of quality and FDA compliance. All products are manufactured in compliance
with current Good Manufacturing Processes (“cGMP”), and our internal quality system requires us to enter quality agreements with and audit all of our
manufacturers prior to commercializing product. Our choice to rely on external manufacturers significantly reduces the amount of capital invested in our
business and allows us the flexibility to pursue a broad range of opportunities beyond the specific capabilities of a single facility.
Licensing Arrangements
Certain products in our portfolio were acquired externally through the licensing or acquisition of existing development products including:
Biorphen. We acquired the exclusive license to market Biorphen in the United States pursuant to an Exclusive License and Supply Agreement dated
February 8, 2019 between us and Sintetica. Pursuant to the terms of the agreement, we will be responsible for marketing activities and Sintetica will be
responsible for development, manufacturing, and regulatory activities related to obtaining regulatory approval. We paid Sintetica a licensing payment of $2
million upon execution of the agreement and paid an additional $750,000 upon commercial launch of the product. Sintetica supplies product to us at its direct
costs. We retain 5% of net sales as a marketing fee. Sintetica receives the first $500,000 of product profits, and all additional profit will be split 50% to us and
50% to Sintetica. The agreement has a 10-year term from first commercial sale of product.
ET-105. On June 12, 2019, we entered into an Exclusive Licensing and Supply Agreement (the “ET-105 License Agreement”) with Aucta
Pharmaceuticals, Inc. (“Aucta”) for marketing rights in the United States to ET-105. Pursuant to the terms of the ET-105 License Agreement, we will be
responsible for marketing activities and Aucta will be responsible for development, manufacturing, and regulatory activities related to obtaining regulatory
approval. We paid Aucta a licensing payment of $2,000,000 in August 2019 upon receiving an acceptance for review letter from the FDA and will pay
$2,000,000 upon FDA approval and the commencement of commercial sales of the product and another $1,000,000 upon issuance of an Orange-book listed
patent. Aucta will receive a low double-digit royalty on net sales and will be entitled to receive additional milestone payments of up to $18,000,000 in total
based on commercial success of the product, including: $1,000,000 when net sales exceed $10 million in a calendar year; $2,000,000 when net sales exceed
$20 million in a calendar year; $5,000,000 when net sales exceed $50 million in a calendar year; and $10,000,000 when net sales exceed $100 million in a
calendar year.
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EM-100. We acquired the exclusive rights to develop, manufacture and sell the EM-100 product in the United States pursuant to a Sales and
Marketing Agreement dated August 11, 2017 between us and Eyemax LLC (“Eyemax”), an entity affiliated with our Chief Executive Officer (the “Sales
Agreement”). On February 18, 2019, we entered into an Amended and Restated Agreement (the “Amended Agreement”) with Eyemax amending the Sales
Agreement. Pursuant to the Amended Agreement, Eyemax sold us all of its right, title and interest in EM-100, including any such product that incorporates or
utilizes Eyemax’s intellectual property rights. Pursuant to the Amended Agreement, we remain obligated to pay Eyemax two milestones: (i) one milestone
payment for $250,000 upon regulatory approval in the territory by the FDA of the first single agent product and (ii) one milestone payment for $500,000
following the first commercial sale of the first single agent product in the territory. Following payment of the milestones, we are entitled to retain all of the
non-royalty transaction revenues and royalties up to $2,000,000 (the “Recovery Amount”). After we have retained the full Recovery Amount, we are entitled
to retain half of all royalty and non-royalty transaction revenue.
On February 18, 2019, we entered into an Asset Purchase Agreement with Bausch. Pursuant to the Asset Purchase Agreement, we sold all of our
right, title and interest in EM-100 in the United States, including any such product that incorporates or utilizes our intellectual property rights with respect to
EM-100. Pursuant to the Asset Purchase Agreement, Bausch paid us an upfront payment of $500,000 and Bausch is required to pay us a milestone payment
of $1,500,000 upon the first sale of the product. Bausch is required to pay us a royalty in the low-double digit percentage range on net sales for a period of 10
years from the date of the first commercial sale of the first single agent EM-100 product in the United States. In the event that any product with the same sole
active pharmaceutical ingredient (“API”) as EM-100 is launched in the United States by any person other than Bausch (or its affiliates) during the term of
Bausch’s royalty commitment, then the royalty rate will be reduced to a lower specified percentage. In the event that EM-100’s market share in the territory
falls below a certain percentage of the target market during the term of Bausch’s royalty commitment, then the royalty rate will be further reduced to a lower
specified percentage.
ET-103. We acquired the exclusive license to develop, manufacture and sell ET-103 in the United States pursuant to an Exclusive License and
Supply Agreement dated August 3, 2018 between us and Liqmeds Worldwide Limited, an unaffiliated entity. Pursuant to the agreement, we will be
responsible for, and shall own, all regulatory filings and approvals at our expense, provided that we shall have the right to recoup 35% of any regulatory filing
fees from the initial profits from the sale of ET-103 and, provided further, the licensor shall be responsible for any bioequivalence study and shall be
responsible for 60% of the costs of such study. An affiliate of the licensor shall manufacture the ET-103 and sell it to us at its cost. We paid the licensor
$350,000 upon execution of the agreement and will pay the licensor $1,500,000 upon the FDA’s acceptance of an NDA for review, $1,000,000 upon FDA
approval, $1,500,000 upon issuance of patent covering ET-103 listed in the FDA’s Orange Book and $500,000 in the event of product sales in excess of
$10,000,000 in any calendar year. In addition, we are required to pay the licensor 35% of the net profit from product sales. The license agreement is for an
initial term of ten years from the date of the first commercial sale of the product, subject to two-year renewals unless either party elects to terminate no less
than 12 months prior to the then current term.
DS-300. We acquired the exclusive rights to develop, manufacture and sell the DS-300 product in the United States pursuant to a Sales and
Marketing Agreement dated November 17, 2017, as amended on August 29, 2018, with an unaffiliated third party. Pursuant to the agreement, the licensor is
responsible for obtaining FDA approval, at its expense, and we are responsible for commercializing the product in the United States, at our expense. The
agreement has a term of ten years from the date of the first commercial sale of the DS-300, subject to one five-year extension at our option. The licensor may
terminate the agreement if we choose not to launch the DS-300, for commercial reasons only, within three months after FDA approval or if during the first
calendar year following the first commercial sale of the DS-300 net sales of the product do not exceed $1 million. The agreement also contains customary
representations, warranties, covenants and indemnities by the parties. In February 2020, we executed an amendment to the Sales and Marketing Agreement.
Under the revised terms, Eton will be responsible for Paragraph IV related litigation and will be entitled to 62.5% of product profit, generally defined as gross
profit less certain fees and costs incurred by us.
DS-100. We acquired the exclusive rights to develop, manufacture and sell the DS-100 product in the United States pursuant to an Exclusive
Development and Supply Agreement dated July 9, 2017 between us and Andersen Pharma, LLC, an entity affiliated with our Chief Executive Officer. We
also hold an option to purchase the DS-100 product and all related intellectual property and government approvals. Pursuant to the agreement, the licensor is
responsible for obtaining FDA approval at its expense and manufacturing the product for sale to us at its cost, however we are responsible for the
advancement of the FDA submission fees, which we have the right to recoup from the initial profits from product sales prior to any profit split. We are
responsible for commercializing the product in the United States at our expense. We paid the licensor $750,000 upon execution of the agreement and will pay
the licensor $750,000 upon successful completion of a registration batch of product, $750,000 upon submission of an NDA and $750,000 upon FDA
approval. We will also pay the licensor 50% of the net profit from the sale of the product. The license agreement is for an initial term of five years from the
first commercial sale of the product, subject to successive two-year renewals unless either party elects to terminate the agreement. The agreement also
contains customary representations, warranties, covenants and indemnities by the parties.
7
ET-104. We acquired the exclusive license to sell ET-104 in the United States pursuant to an Exclusive License and Supply Agreement dated
January 23, 2019 between us and Liqmeds Worldwide Limited. Pursuant to the agreement, we will be responsible for regulatory and marketing activities. We
paid the licensor $350,000 upon execution of the agreement and will pay the licensor additional milestones of up to $2.15 million based on the achievement
of certain development and commercial milestones. In addition, we are required to pay the licensor 35% of the net profit from product sales. The agreement is
for an initial term of 10 years from the date of the first commercial sale of the product, and we will retain sole ownership after expiration of the agreement.
ET-203. We acquired the exclusive license to market ET-203 pursuant to an Exclusive License and Supply Agreement dated February 8, 2019
between us and Sintetica. Pursuant to the terms of the agreement, we will be responsible for marketing activities and Sintetica will be responsible for
development, manufacturing, and regulatory activities related to obtaining regulatory approval. We paid Sintetica a licensing payment of $1 million upon
execution of the agreement and will pay an additional $750,000 upon FDA approval of the product candidate. Upon approval, Sintetica will supply ET-203 to
us at its direct costs. We will retain 5% of net sales as a marketing fee. Sintetica will be entitled to receive the first $500,000 of product profits. All additional
profit will be split 50% to us and 50% to Sintetica. The agreement has a 10-year term from first commercial sale of product. In January of 2020, we amended
the agreement as a result of the product’s initial new drug application receiving a refuse to file letter from the FDA, Eton was returned the initial $1 million
licensing payment that we paid to Sintetica upon execution of the original agreement. If Sintetica resubmits the product NDA and the FDA accepts it for
review, Eton will repay the $1 million licensing fee.
Intellectual Property
Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications related to our
proprietary technology, inventions and improvements that are important to the development of our business. We also rely on our trade secrets, know-how and
continuing technological innovation to develop and maintain our proprietary position. We vigorously defend our intellectual property to preserve our rights
and gain the benefit of our technological investments. Our business is not dependent, however, upon any single patent, trademark or contract.
Our development partner has filed a patent application for ET-104. We intend to seek patent protection on our internally developed products as
circumstances warrant.
Our development partner for ET-105 was granted a patent by the United States Patent and Trademark Office for the product’s unique formulation.
We expect the patent to be Orange Book listed after product approval.
We have applied for trademark registration of the marks “Eton” and “Eton Pharmaceuticals” with the U.S. Patent and Trademark Office.
8
Government Regulations and Funding
Pharmaceutical companies are subject to extensive regulation by foreign, federal, state and local agencies, such as the FDA, and various European
regulatory authorities. The manufacture, distribution, marketing and sale of pharmaceutical products are subject to government regulation in the United States
and various foreign countries. Additionally, in the United States, we must follow rules and regulations established by the FDA requiring the presentation of
data indicating that our products are safe and efficacious and are manufactured in accordance with cGMP regulations. If we do not comply with applicable
requirements, we may be fined, the government may refuse to approve our marketing applications or allow us to manufacture or market our products, and we
may be criminally prosecuted. We, our manufacturers and CROs may also be subject to regulations under other foreign, federal, state and local laws,
including, but not limited to, the U.S. Occupational Safety and Health Act, the Resource Conservation and Recovery Act, the Clean Air Act and import,
export and customs regulations as well as the laws and regulations of other countries. The U.S. government has increased its enforcement activity regarding
illegal marketing practices domestically and internationally. As a result, pharmaceutical companies must ensure their compliance with the Foreign Corrupt
Practices Act and federal healthcare fraud and abuse laws, including the False Claims Act.
These regulatory requirements impact our operations and differ from one country to another, so that securing the applicable regulatory approvals of
one country does not imply the approval of another country. The approval procedures involve high costs and are manpower intensive, usually extend over
many years and require highly skilled and professional resources.
FDA Market Approval Process
The steps usually required to be taken before a new drug may be marketed in the United States generally include:
● completion of pre-clinical laboratory and animal testing;
● completion of required chemistry, manufacturing and controls testing;
● the submission to the FDA of an investigational new drug, or IND, the application for which must be evaluated and found acceptable by the
FDA before human clinical trials may commence;
● performance of adequate and well-controlled human clinical trials to establish the safety, pharmacokinetics and efficacy of the proposed drug for
its intended use;
● submission and approval of an NDA; and
● agreement with FDA of the language on the package insert.
Clinical studies are conducted under protocols detailing, among other things, the objectives of the study, what types of patients may enter the study,
schedules of tests and procedures, drugs, dosages, and length of study, as well as the parameters to be used in monitoring safety, and the efficacy criteria to be
evaluated. A protocol for each clinical study and any subsequent protocol amendments must be submitted to the FDA as part of the IND process.
Clinical trials are usually conducted in three phases. Phase 1 clinical trials are normally conducted in small groups of healthy volunteers to assess
safety of various dosing regimens and pharmacokinetics. After a safe dose has been established, in Phase 2 clinical trials the drug is administered to small
populations of sick patients to look for initial signs of efficacy in treating the targeted disease or condition and to continue to assess safety. Phase 3 clinical
trials are usually multi-center, double-blind controlled trials in larger numbers of subjects at various sites to assess as fully as possible both the safety and
effectiveness of the drug.
Clinical trials must be conducted in accordance with the FDA’s good clinical practices (“GCP”) requirements. The FDA may order the temporary or
permanent discontinuation of a clinical study at any time or impose other sanctions if it believes that the clinical study is not being conducted in accordance
with FDA requirements or that the participants are being exposed to an unacceptable health risk. An institutional review board (“IRB”) generally must
approve the clinical trial design and patient informed consent at study sites that the IRB oversees and also may halt a study, either temporarily or permanently,
for failure to comply with the IRB’s requirements, or may impose other conditions. Additionally, some clinical studies are overseen by an independent group
of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board or committee. This group recommends whether or not a
trial may move forward at designated check points based on access to certain data from the study. The clinical study sponsor may also suspend or terminate a
clinical trial based on evolving business objectives and/or competitive climate.
9
As a product candidate moves through the clinical testing phases, manufacturing processes are further defined, refined, controlled and validated. The
level of control and validation required by the FDA increases as clinical studies progress. We and the third-party manufacturers on which we rely for the
manufacture of our product candidates and their respective components (including the API) are subject to requirements that drugs be manufactured, packaged
and labeled in conformity with cGMP. To comply with cGMP requirements, manufacturers must continue to spend time, money and effort to meet
requirements relating to personnel, facilities, equipment, production and process, labeling and packaging, quality control, recordkeeping and other
requirements.
Assuming completion of all required testing in accordance with all applicable regulatory requirements, detailed information on the product candidate
is submitted to the FDA in the form of an NDA, requesting approval to market the product for one or more indications, together with payment of a user fee,
unless waived. An NDA includes all relevant data available from pertinent nonclinical and clinical studies, including negative or ambiguous results as well as
positive findings, together with detailed information on the chemistry, manufacture, controls and proposed labeling, among other things. To support marketing
approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the product candidate for its intended use to the
satisfaction of the FDA.
If an NDA submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under the Prescription Drug User Fee Act (“PDUFA”)
the FDA’s goal is to complete its initial review and respond to the applicant within ten months of submission, unless the application relates to an unmet
medical need, or is for a serious or life-threatening indication, in which case the goal may be within six months of NDA submission. However, the review
process and the target response date under PDUFA may be extended if the FDA requests or the NDA sponsor otherwise provides additional information or
clarification regarding information already provided in the NDA. During its review of an NDA, the FDA may refer the application to an advisory committee
for review, evaluation and recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory
committee, but it typically follows such recommendations. Data from clinical studies are not always conclusive and the FDA and/or any advisory committee
it appoints may interpret data differently than the applicant.
After the FDA evaluates the NDA and inspects manufacturing facilities where the drug product and/or its API will be produced, it will either
approve commercial marketing of the drug product with prescribing information for specific indications or issue a complete response letter indicating that the
application is not ready for approval and stating the conditions that must be met in order to secure approval of the NDA. If the complete response letter
requires additional data and the applicant subsequently submits that data, the FDA nevertheless may ultimately decide that the NDA does not satisfy its
criteria for approval. The FDA could also approve the NDA with a Risk Evaluation and Mitigation Strategies (“REMS”) plan to mitigate risks, which could
include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other
risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling, development of adequate controls and
specifications, or a commitment to conduct post-marketing testing. Such post-marketing testing may include Phase 4 clinical trials and surveillance to further
assess and monitor the product’s safety and efficacy after approval.
If the FDA approves one of our product candidates, we will be required to comply with a number of post-approval regulatory requirements. We
would be required to report, among other things, certain adverse reactions and production problems to the FDA, provide updated safety and efficacy
information and comply with requirements concerning advertising and promotional labeling for any of our products. Also, quality control and manufacturing
procedures must continue to conform to cGMP after approval, and the FDA periodically inspects manufacturing facilities to assess compliance with cGMP,
which imposes extensive procedural, substantive and record keeping requirements. If we seek to make certain changes to an approved product, such as certain
manufacturing changes, we will need FDA review and approval before the change can be implemented. For example, if we change the manufacturer of a
product or our API, the FDA may require stability or other data from the new manufacturer, and such data will take time and are costly to generate, and the
delay associated with generating these data may cause interruptions in our ability to meet commercial demand, if any. While physicians may use products for
indications that have not been approved by the FDA, we may not label or promote the product for an indication that has not been approved. Securing FDA
approval for new indications is similar to the process for approval of the original indication and requires, among other things, submitting data from adequate
and well-controlled studies that demonstrate the product’s safety and efficacy in the new indication. Even if such studies are conducted, the FDA may not
approve any change in a timely fashion, or at all.
The FDA may also require post-marketing testing, or Phase 4 testing, as well as risk minimization action plans and surveillance to monitor the
effects of an approved product or place conditions or an approval that could otherwise restrict the distribution or use of the product.
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Section 505(b)(2) New Drug Applications
We intend to submit applications for certain product candidates via the 505(b)(2) regulatory pathway. As an alternate path for FDA approval of new
indications or new formulations of previously approved products, a company may submit a Section 505(b)(2) NDA, instead of a “stand-alone” or “full” NDA.
Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (“FDCA”) was enacted as part of the Drug Price Competition and Patent Term Restoration Act
of 1984, otherwise known as the Hatch-Waxman Amendments. Section 505(b)(2) permits the submission of an NDA where at least some of the information
required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Some
examples of products that may be allowed to follow a 505(b)(2) path to approval are drugs that have a new dosage form, strength, route of administration,
formulation or indication.
The Hatch-Waxman Amendments permit the applicant to rely upon certain published nonclinical or clinical studies conducted for an approved
product or the FDA’s conclusions from prior review of such studies. The FDA may require companies to perform additional studies or measurements to
support any changes from the approved product. The FDA may then approve the new product for all or some of the labeled indications for which the
reference product has been approved, as well as for any new indication supported by the Section 505(b)(2) application. While references to nonclinical and
clinical data not generated by the applicant or for which the applicant does not have a right of reference are allowed, all development, process, stability,
qualification and validation data related to the manufacturing and quality of the new product must be included in an NDA submitted under Section 505(b)(2).
To the extent that the Section 505(b)(2) applicant is relying on the FDA’s conclusions regarding studies conducted for an already approved product,
the applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Approved Drug Products with Therapeutic
Equivalence Evaluations, or Orange Book. Specifically, the applicant must certify that: (i) the required patent information has not been filed; (ii) the listed
patent has expired; (iii) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed
patent is invalid or will not be infringed by the new product. The Section 505(b)(2) application also will not be approved until any non-patent exclusivity,
such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the reference product has expired. If the Orange Book
certifications outlined above are not accomplished, the Section 505(b)(2) applicant may invest a significant amount of time and expense in the development of
its products only to be subject to significant delay and patent litigation before its products may be commercialized.
Section 505(j) Abbreviated New Drug Applications
The 505(j) pathway is used for product candidates that are therapeutically equivalent to an approved product. The underlying premise of the 505(j)
pathway is that a product candidate classified as therapeutically equivalent can be substituted for the approved product with the full expectation that the
substituted product will produce the same clinical effect and safety profile as the approved product when administered under the same conditions. A product
candidate utilizing the 505(j) pathway requires an abbreviated new drug application, or ANDA, which relies on the FDA’s finding that the previously
approved drug candidate is safe and effective. An ANDA generally must contain information to show that the product candidate is the same as the approved
product with respect to API, conditions of use, route of administration, dosage form, strength and labeling, with certain permissible differences, and is the
bioequivalent of the approved drug. The 505(j) pathway typically requires no clinical testing other than a bioequivalence trial. While the 505(j) pathway is
typically shorter and less expensive than the 505(b)(2) pathway, the 505(b)(2) pathway allows greater flexibility as to the characteristics of the product
candidate.
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Other U.S. Healthcare Laws and Compliance Requirements
For products distributed in the United States, we will also be subject to additional healthcare regulation and enforcement by the federal government
and the states in which we conduct our business. Applicable federal and state healthcare laws and regulations include the following:
● The U.S. Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving, or providing
remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order, lease, or
recommendation of, any good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid;
● The federal civil and criminal false claims laws, including the U.S. False Claims Act, can be enforced by individuals, on behalf of the
government, through civil whistleblower or qui tam actions, and the civil monetary penalties law, prohibits individuals or entities from, among
other things, knowingly presenting, or causing to be presented, to the federal government claims for payment that are false or fraudulent or
making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government;
● The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which prohibits, among other things, executing a scheme to
defraud any healthcare benefit program and knowingly and willfully falsifying, concealing or covering up a material fact or making any
materially false statement in connection with the delivery of or payment for healthcare benefits, items, or services;
● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, imposes
obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually
identifiable health information;
● The Physician Payments Sunshine Act which requires certain manufacturers of drugs, devices, biologics and medical supplies for which
payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the
Centers for Medicare & Medicaid Services (“CMS”) information related to payments or other transfers of value made to physicians and teaching
hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
● Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and
claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, state laws that
require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance
guidance promulgated by the federal government; state and local laws that require drug manufacturers to report information related to payments
and other transfers of value to physicians and other healthcare providers or marketing expenditures; state laws that require the reporting of
information related to drug pricing; state and local laws requiring the registration of pharmaceutical sales and medical representatives; and state
and foreign laws, such as the General Data Protection Regulation (EU) 2016/679, governing the privacy and security of health information in
some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating
compliance efforts.
Because of the breadth of these laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our
business activities could be subject to challenge under one or more of such laws. If our operations are found to be in violation of any of the federal or state
laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including significant criminal, civil, and
administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government healthcare programs, integrity oversight
and reporting obligations to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations.
Reimbursement
Sales of our products in the United States may depend, in part, on the extent to which the costs of the products will be covered and reimbursed by
third-party payors, such as government health programs, commercial insurance and managed health care organizations. These third-party payors are
increasingly challenging the prices charged for medical products and services. Additionally, the containment of health care costs has become a priority of
federal and state governments, and the prices of drugs have been a focus in this effort. The United States government, state legislatures and foreign
governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and
requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in
jurisdictions with existing controls and measures, could further limit our net revenue and results. If these third-party payors do not consider our products to be
cost-effective compared to other available therapies, they may not cover our products after approval as a benefit under their plans or, if they do, the level of
payment may not be sufficient to allow us to sell our products on a profitable basis.
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The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, (the “MMA”), imposed new requirements for the distribution and
pricing of prescription drugs for Medicare beneficiaries and included a major expansion of the prescription drug benefit under Medicare Part D. Under Part D,
Medicare beneficiaries may enroll in prescription drug plans offered by private entities which will provide coverage of outpatient prescription drugs. Part D
plans include both stand-alone prescription drug benefit plans and prescription drug coverage as a supplement to Medicare Advantage plans. Unlike Medicare
Parts A and B, Part D coverage is not standardized. Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug
plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level. However, Part D prescription drug formularies must
include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the drugs in each category or class. Any
formulary used by a Part D prescription drug plan must be developed and reviewed by a pharmacy and therapeutic committee. Government payment for some
of the costs of prescription drugs may increase demand for products for which we receive marketing approval. However, any negotiated prices for our
products covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain. Moreover, while the MMA applies only to
drug benefits for Medicare beneficiaries, private third-party payors often follow Medicare coverage policy and payment limitations in setting their own
payment rates. Any reduction in payment that results from the MMA may result in a similar reduction in payments from non-governmental payors.
Decreases in third-party reimbursement for our products or a decision by a third-party payor to not cover our products could reduce physician usage
of the products and have a material adverse effect on our sales, results of operations and financial condition.
Healthcare Reform.
In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding
the health care system that could prevent or delay marketing approval pharmaceutical products, restrict or regulate post-approval activities and affect our
ability to profitably sell our product candidates. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales
and promotional activities for pharmaceutical products.
For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act,
(collectively, the “Health Care Reform Law”) was enacted, which substantially changes the way health care is financed by both governmental and private
insurers, and significantly impacts the U.S. pharmaceutical industry. The Health Care Reform Law, among other things, imposed reporting requirements on
manufacturers related to drug samples and financial relationships with physicians and teaching hospitals, increased the minimum Medicaid rebates owed by
manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations,
established annual fees on manufacturers of certain branded prescription drugs, and established a Medicare Part D coverage gap discount program.
Some of the provisions of the Health Care Reform Law have yet to be implemented, and there have been judicial and Congressional challenges to
certain aspects of the Health Care Reform Law, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the Health Care
Reform Law. Since January 2017, President Trump has signed two executive orders and other directives designed to delay, circumvent or loosen certain
requirements mandated by the Health Care Reform Law. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part
of the Health Care Reform Law. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes
under the Health Care Reform Law have been signed into law. The Tax Cuts and Jobs Act of 2017 (the “Tax Act”) included a provision which repealed,
effective January 1, 2019, the tax-based shared responsibility payment imposed by the Health Care Reform Law on certain individuals who fail to maintain
qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” On January 22, 2018, President Trump signed a
continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain Health Care Reform Law-mandated fees, including the
so-called “Cadillac” tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on
market share, and the medical device excise tax on non-exempt medical devices. The Bipartisan Budget Act of 2018, among other things, amended the Health
Care Reform, effective January 1, 2019, to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers
who participate in Medicare Part D and to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole”. On December 14,
2018, a Texas U.S. District Court Judge ruled that the Health Care Reform is unconstitutional in its entirety because the “individual mandate” was repealed by
Congress as part of the Tax Act. While the Texas U.S. District Court Judge, as well as the Trump administration and CMS, have stated that the ruling will
have no immediate effect pending appeal of the decision, it is unclear how this decision, subsequent appeals, and other efforts to repeal and replace the Health
Care Reform will impact the Health Care Reform Law.
In addition, other legislative changes have been proposed and adopted in the United States since the Health Care Reform Law was enacted. These
changes include, among others, aggregate reductions of Medicare payments to providers of up to 2% per fiscal year and an increase in the statute of
limitations period for the government to recover overpayments to providers from three to five years.
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Further, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of
prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation
designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and
reform government program reimbursement methodologies for products. For example, the Trump administration released a “Blueprint” to lower drug prices
and reduce out of pocket costs of drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of certain
federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by
consumers. On January 31, 2019, the Health and Human Services (“HHS”) Office of Inspector General proposed modifications to the U.S. Anti-Kickback
Statute discount safe harbor for the purpose of reducing the cost of drug products to consumers which, among other things, if finalized, will affect discounts
paid by manufacturers to Medicare Part D plans, Medicaid managed care organizations and pharmacy benefit managers working with these organizations.
While some of these and other proposed measures may require additional authorization to become effective, Congress and the Trump administration have
each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.
Moreover, in December 2016, the 21st Century Cures Act was signed into law. The 21st Century Cures Act, among other things, is intended to
modernize the regulation of drugs and biologics and spur innovation, but it has not yet been fully implemented and its ultimate implementation is unclear.
Additionally, the Trump administration has taken several executive actions, including the issuance of a number of executive orders, that could impose
significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities such as implementing statutes
through rulemaking, issuance of guidance and review and approval of marketing applications.
Employees
We currently have 17 full-time employees, ten of whom are engaged in research and development activities and seven of whom are engaged in
general corporate and strategy roles. We periodically utilize outside consultants on an as-needed basis, including medical consultants.
Corporate and Other Information
We were incorporated under the laws of the state of Delaware in April 2017. We were initially a wholly owned subsidiary of Harrow Health Inc.
(“Harrow”) but are no longer a subsidiary of Harrow. Our principal executive offices are located at 21925 W. Field Parkway, Suite 235, Deer Park, Illinois,
60010, and our telephone number is (847) 787-7361. Our corporate website address is www.etonpharma.com, to which we regularly post copies of our press
releases as well as links to reports we have filed with the SEC, which are available free of charge as soon as reasonably practicable after being electronically
filed with or furnished to the SEC. Interested persons can subscribe on our website to email alerts that are sent automatically when we issues press releases,
file reports with the SEC or post certain other information to our website. Information contained on or accessible through our website is not a part of this
Annual Report on Form 10-K or our other filings with the SEC.
We own two U.S. federal trademark applications and unregistered trademarks, including our company name. All other trademarks or trade names
referred to in this Annual Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Annual Report
are referred to without the symbols ® and ™, but such references should not be construed as any indication that their respective owners will not assert, to the
fullest extent under applicable law, their rights thereto.
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Item 1A. Risk Factors
We operate in a dynamic and rapidly changing environment that involves numerous risks and uncertainties. Certain factors may have a material
adverse effect on our business, financial condition and results of operations, and you should carefully consider them. Accordingly, in evaluating our business,
we encourage you to consider the following discussion of risk factors, in its entirety, in addition to other information contained in this Annual Report on Form
10-K and our other public filings with the SEC. Other events that we do not currently anticipate or that we currently deem immaterial may also affect our
results of operations and financial condition.
Risks Relating to Our Business
We are a specialty pharmaceutical company with a limited operating history, and it is difficult for potential investors to evaluate our business.
We are a specialty pharmaceutical company founded in April 2017 and have only recently commenced revenue-producing operations and our
historical operations have primarily consisted of the preliminary formulation, testing and development of our various product candidates. Our limited
operating history makes it difficult for potential investors to evaluate our initial product candidates or our prospective operations. As an early stage company,
we are subject to all the risks inherent in the initial organization, financing, expenditures, complications and delays in a new business. Further,
biopharmaceutical product development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive business.
Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the early
stages of product development and commercialization, especially clinical-stage biopharmaceutical companies such as ours. As a company with a limited
operating history, we may be unable to:
● successfully implement or execute our current business plan, or develop a business plan that is sound;
● successfully complete clinical trials and obtain regulatory approval for the marketing of our additional product candidates;
● successfully contract for the manufacture of our clinical drug products and establish a commercial drug supply;
● secure market exclusivity or adequate intellectual property protection for our product candidates;
● attract and retain an experienced management and advisory team; or
● raise sufficient funds in the capital markets to effectuate our business plan, including clinical development, regulatory approval and ongoing
commercialization for our product candidates.
There can be no assurance that our efforts will be successful or that we will ultimately be able to attain profitability. If we cannot successfully
execute any one of the foregoing, our business may not succeed.
We have a history of significant operating losses and anticipate continued operating losses for the foreseeable future.
To date, we are not profitable and have incurred losses since our inception in April 2017. For the years ended December 31, 2019 and 2018, we
incurred a net loss of $18.3 million and $12.7 million, respectively, and our operations used $18.0 million and $8.1 million of cash and cash equivalents,
respectively. We have realized limited revenues from two products and expect to incur significant development expenses for our product candidates in the
United States and elsewhere. We may never be able to obtain regulatory approval for the marketing of our additional product candidates for any indication in
the United States or internationally and there can be no assurance that we will generate significant revenues or ever achieve profitability.
We expect to have significant research, regulatory and development expenses as we advance our product candidates.
As a result, we expect to incur substantial losses for the foreseeable future. We are uncertain when or if we will be able to achieve or sustain
profitability. If we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Failure to become and remain
profitable may impair our ability to sustain operations and adversely affect our business and our ability to raise capital. If we are unable to generate positive
cash flow within a reasonable period of time, we may be unable to further pursue our business plan or continue operations.
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We could need additional financing to execute our business plan and fund operations, which additional financing may not be available on reasonable
terms or at all.
As of December 31, 2019, we had total assets of $17.1 million and working capital of $13.0 million. We received $22.0 million in net proceeds from
our initial public offering (“IPO”) in November 2018. In November 2019, we entered into a $10.0 million debt facility with SWK Holdings Corporation, and
we received $5.0 million at closing with the option to drawdown additional capital if certain product candidates are approved. We could require additional
funding at a future point in time. In the event we require additional capital, we will endeavor to seek additional funds through various financing sources,
including the sale of our equity and debt securities, licensing fees for our technology and joint ventures with industry partners. In addition, we will consider
alternatives to our current business plan that may enable to us to achieve additional revenue producing operations and meaningful commercial success with a
smaller amount of capital. However, there can be no guarantees that such funds will be available on commercially reasonable terms, if at all. If such financing
is not available on satisfactory terms, we may be unable to further pursue our business plan and we may be unable to continue operations.
We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
As our development and commercialization plans and strategies develop, we will need to expand the size of our employee and consultant/contractor
base. Future growth would impose significant added responsibilities on members of management, including the need to identify, recruit, maintain, motivate
and integrate additional employees. In addition, our management may have to divert a disproportionate amount of its attention away from our day-to-day
activities and devote a substantial amount of time to managing these growth activities. Our future financial performance and our ability to commercialize our
product candidates and any other future product candidates and our ability to compete effectively will depend, in part, on our ability to effectively manage our
future growth.
If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy. In
addition, the loss of the services of our senior management would adversely impact our business prospects.
Our management team has expertise in many different aspects of drug development and commercialization. However, our ability to compete in the
highly competitive pharmaceuticals industry depends in large part upon our ability to attract and retain highly qualified managerial, scientific and medical
personnel. We will need to hire additional personnel as we further develop our product candidates. Competition for skilled personnel in our market is intense
and competition for experienced scientists may limit our ability to hire and retain highly qualified personnel on acceptable terms. Despite our efforts to retain
valuable employees, members of our management and scientific teams may terminate their employment with us on short notice. The loss of the services of
any of our executive officers or other key employees, or our inability to hire targeted executives, could potentially harm our business, operating results or
financial condition. In particular, we believe that the loss of the services of our chief executive officer would have a material adverse effect on our business.
Other pharmaceutical companies with which we compete for qualified personnel have greater financial and other resources, different risk profiles,
and a longer history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these
characteristics may be more appealing to high-quality candidates than what we have to offer. If we are unable to continue to attract and retain high-quality
personnel, the rate and success at which we can develop and commercialize product candidates would be limited.
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product
candidates.
We face a potential risk of product liability as a result of the commercialization of our Biorphen product and clinical testing of our product
candidates and will face an even greater risk if we commercialize our current product candidates or any other future product. For example, we may be sued if
Biorphen or any product we develop, including any of our product candidates, or any materials that we use in our products allegedly causes injury or is found
to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in
manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. In the United
States, claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may
incur substantial liabilities or be required to limit commercialization of our product candidates. Even successful defense would require significant financial
and management resources. Regardless of the merits or eventual outcome, liability claims may result in:
● decreased demand for Biorphen or any of our product candidates or any future products that we may develop;
● injury to our reputation;
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● withdrawal of clinical trial participants;
● costs to defend the related litigation;
● a diversion of management’s time and our resources;
● substantial monetary awards to trial participants or patients;
● product recalls, withdrawals or labeling, marketing or promotional restrictions;
● the inability to commercialize some or all of our product candidates; and
● a decline in the value of our stock.
We carry product liability insurance we consider adequate for our current level of expected Biorphen sales, clinical testing and product development.
Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent
or inhibit the commercialization of Biorphen or additional products we develop. Although we will endeavor to obtain and maintain such insurance in
coverage amounts we deem adequate, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not
covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions,
and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a
settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay
such amounts.
We may acquire businesses or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.
We may acquire additional businesses or products, form strategic alliances or create joint ventures with third parties that we believe will complement
or augment our existing business. If we acquire businesses with promising markets or technologies, we may not be able to realize the benefit of acquiring
such businesses if we are unable to successfully integrate them with our existing operations and company culture. We may encounter numerous difficulties in
developing, manufacturing and marketing any new products resulting from a strategic alliance or acquisition that delay or prevent us from realizing their
expected benefits or enhancing our business. We cannot assure you that, following any such acquisition, we will achieve the expected synergies to justify the
transaction.
We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any
cybersecurity incidents, could harm our ability to operate our business effectively.
Despite the implementation of security measures, our internal computer systems and those of third parties with which we contract are vulnerable to
damage from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. System
failures, accidents or security breaches could cause interruptions in our operations, and could result in a material disruption of our product development and
clinical activities and business operations, in addition to possibly requiring substantial expenditures of resources to remedy. Cybersecurity attacks in particular
are evolving and include, but are not limited to, malicious software, attempts to gain unauthorized access to data and other electronic security breaches that
could lead to disruptions in systems, misappropriation of our confidential or otherwise protected information and corruption of data. The loss, theft or
sabotage of product development or clinical trial data could result in delays in our regulatory approval efforts and significantly increase our costs to recover or
reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate
disclosure of confidential or proprietary information, we could incur liability and our development programs and the development of our product candidates
could be delayed.
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Sales of counterfeits of any of our product candidates, as well as unauthorized sales of any of our product candidates, may have adverse effects on our
revenues, business and results of operations and damage our brand and reputation.
Our Biorphen product on our product candidates may become subject to competition from counterfeit pharmaceutical products, which are
pharmaceutical products sold under the same or very similar brand names and/or having a similar appearance to genuine products, but which are sold without
proper licenses or approvals. Such products divert sales from genuine products, often are of lower cost, often are of lower quality (having different ingredients
or formulations, for example), and have the potential to damage the reputation for quality and effectiveness of the genuine product. Obtaining regulatory
approval for our product candidates is a complex and lengthy process. If during the period while the regulatory approval is pending, illegal sales of counterfeit
products begin, consumers may buy such counterfeit products, which could have an adverse impact on our revenues, business and results of operations. In
addition, if illegal sales of counterfeits result in adverse side effects to consumers, we may be associated with any negative publicity resulting from such
incidents. Although pharmaceutical regulation, control and enforcement systems throughout the world have been increasingly active in policing counterfeit
pharmaceuticals, we may not be able to prevent third parties from manufacturing, selling or purporting to sell counterfeit products competing with our
Biorphen product on our product candidates. Such sales may also be occurring without our knowledge. The existence and any increase in production or sales
of counterfeit products or unauthorized sales could negatively impact our revenues, brand reputation, business and results of operations.
We have entered into several arrangements with related parties for the development and marketing of certain product candidates and these arrangements
present potential conflicts of interest.
Our Chief Executive Officer, Sean Brynjelsen, has a material ownership interest in several companies from which we have licensed or acquired
product development and marketing rights. See, “Notes to Financial Statements - Related Party Transactions.” We are required to pay these entities a
combination of licensing fees, milestone payments and royalty payments. The transactional agreements also subject us to a loss of our rights to the product
candidates in the event we breach any of our representations, warranties or covenants included in the agreements. While we believe the terms of the
transactional agreements, including the licensing fees, milestone payments and royalty payments, approximate the terms and payments we could have
obtained in an arms’ length transaction with an unaffiliated party, these arrangements may present Mr. Brynjelsen with a conflict of interest in the event of
dispute between the parties. Although we believe we have mechanisms in place to protect the interests of our stockholders, including a board of directors, a
majority of which are independent and have no interest in these related parties, there can be no assurance that a conflict of interest will not arise or that any
such conflict will not adversely impact the interests of our stockholders.
Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization
We depend entirely on the success of Biorphen and our product candidates. If we are unable to generate revenues from our product candidates, our
ability to create stockholder value will be limited.
We have various product candidates are in the early stages of clinical development, and we do not generate revenues from any FDA approved drug
products other than Biorphen. An abbreviated new drug application (“ANDA”) was submitted for our EM-100 product candidate and our DS-300 product. In
addition, an NDA was submitted for ET-105 in May 2019. We plan on submitting our clinical trial protocols and receiving approvals from the FDA and
international regulatory authorities before we commence any clinical trials. We may not be successful in obtaining acceptance from the FDA or comparable
foreign regulatory authorities to start our clinical trials. If we do not obtain such acceptance, the time in which we expect to commence clinical programs for
any product candidate will be extended and such extension will increase our expenses and increase our need for additional capital. Moreover, there is no
guarantee that our clinical trials will be successful or that we will continue clinical development in support of additional product approvals from the FDA or
comparable foreign regulatory authorities for any indication. We note that most product candidates never reach the clinical development stage and even those
that do commence clinical development have only a small chance of successfully completing clinical development and gaining regulatory approval.
Therefore, our business substantially depends entirely on the successful development, regulatory approval and commercialization of our product candidates,
which may never occur.
We face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. We have
existing competitors and potential new competitors in a number of jurisdictions, many of which have or will have substantially greater name recognition,
commercial infrastructures and financial, technical and personnel resources than we have. Established competitors may invest heavily to quickly discover and
develop novel compounds that could make any of our product candidates obsolete or uneconomical. In addition, mergers and acquisitions in the
biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors, potentially
reducing or eliminating our commercial opportunity. Furthermore, such potential competitors may enter the market before us, and their products may be
designed to circumvent our pending patent applications and any patents we may receive. They may also challenge, narrow or invalidate any granted patents or
our patent applications, and such patents and patent applications may fail to provide adequate protection for our product candidates. Any new product that
competes with an approved product may need to demonstrate compelling advantages in efficacy, cost, convenience, tolerability and safety to be commercially
successful. Other competitive factors, including generic competition, could force us to lower prices or could result in reduced sales. In addition, new products
developed by others could emerge as competitors to our product candidates. If we are not able to compete effectively against our current and future
competitors, our business will not grow and our financial condition and operations will suffer.
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We face substantial competition, which may result in others discovering, developing and commercializing products before or more successfully than our
product candidates.
The development and commercialization of new drugs is highly competitive. We face competition (from major pharmaceutical companies, specialty
pharmaceutical companies and biotechnology companies worldwide) with respect to our current product candidates and will face competition with respect to
any product candidates that we may seek to develop or commercialize in the future. We compete directly with companies that focus on 505(b)(2) and generic
drugs, and companies dedicating their resources to novel forms of therapies for these indications. Many of these competitors are attempting to develop
products for our target indications. We face the risk that our competitors will develop a competing product using the same 505(b)(2) pathway that we intend to
pursue. Our business model is to focus on product candidates that we consider to have a shorter timeline to, and lower cost of, regulatory approval. These
attributes can also be taken advantage of by our competitors to develop and obtain marketing approval of a competing product. In addition, following FDA
approval of our product candidates for which we have no patent protection, our competitors may seek to develop a competing product pursuant to the 505(j)
pathway, which is an abbreviated pathway used for the regulatory approval of generic product candidates. As a result of the foregoing, we may find that the
market opportunity for our product candidates for which we have no patent protection is relatively small due to the fact that barriers to entry are low and
generic competition may follow within relatively short time periods after our product is approved. With the proliferation of new drugs and therapies in these
areas, we expect to face increasingly intense competition as new technologies become available. Any product candidates that we successfully develop and
commercialize will compete with existing products and new products that may become available in the future.
There are products already approved for all of the indications we are targeting. Many of these approved products are well established therapies and
are widely accepted by physicians, patients and third-party payors. This may make it difficult for us to achieve our business strategy of replacing existing
products with our product candidates. In addition, where we are able to offer benefits over existing products offered by our competitors, those competitors
may reformulate their drugs in a manner that mimics the benefits offered by our product candidates. As noted below, many of our product candidates are not
eligible for patent protection or the market and data exclusivity provisions under the Federal Food, Drug and Cosmetic Act (“FDCA”). Consequently, our
commercial operations face significant direct competition and our competitors may develop products that are similar to ours and perhaps safer, more effective,
more convenient or less costly than any that we are developing or that would render our product candidates obsolete or non-competitive. Our inability to
successfully compete could negatively impact our business, results of operations and stock price.
Our competitors may obtain FDA or other regulatory approval for comparable products more rapidly than we may obtain approval for ours, and the risk
of our competitors doing so may lead us to develop drug candidates without disclosing certain information with regard to such candidates.
The FDCA provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA, or supplement to an existing NDA or 505(b)(2) NDA if new
clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the
approval of the application, (e.g., for new indications, dosages, strengths or dosage forms of an existing drug). Many of our competitors have significantly
greater financial, manufacturing, marketing, drug development, technical and human resources than we do. As a result, many of our competitors have the
ability to bring a product candidate to market more rapidly than we can and depending on the nature of their product candidate they could substantially delay
the introduction of our product candidate into the market if their product qualifies for the market and data exclusivity provisions under the FDCA. In order to
preserve any competitive advantage, we will, at times, make the decision to pursue a product candidate for which we will not disclose the API, dosage or
reference drug until such time as we believe that any competitive advantage would not be materially compromised by public disclosure of such information,
which in some cases may be as late as our receipt of marketing approval from the FDA. Our business currently depends on our ability to bring our product
candidates to market in a manner that preserves our perceived competitive advantage and any loss of that competitive advantage could negatively impact our
business, results of operations and stock price.
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If we are not able to obtain any required regulatory approvals for our product candidates, we will not be able to commercialize our product candidate and
our ability to generate revenue will be limited.
We may be required to successfully complete clinical trials for our product candidates before we can apply for marketing approval. Even if we
complete any such clinical trials, it does not assure marketing approval. Any such clinical trials may be unsuccessful, which would materially harm our
business. Even if such initial clinical trials are successful, we may be required to conduct additional clinical trials to establish our product candidates’ safety
and efficacy, before an NDA or foreign equivalents can be submitted to the FDA or comparable foreign regulatory authorities for marketing approval of our
product candidates.
Our success depends on the receipt of regulatory approval and the issuance of such regulatory approvals is uncertain and subject to a number of
risks, including the following:
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the results of any required toxicology studies may not support the submission of an IND for our product candidates;
the FDA or comparable foreign regulatory authorities or Institutional Review Boards (“IRB”), may disagree with the design or implementation of
our clinical trials;
we may not be able to provide acceptable evidence of our product candidates’ safety and efficacy;
the results of our clinical trials may not be satisfactory or may not meet the level of statistical or clinical significance required by the FDA or
other regulatory agencies for marketing approval;
the dosing of our product candidates in any required clinical trial may not be at an optimal level;
patients in our clinical trials may suffer adverse effects for reasons that may or may not be related to our product candidates;
the data collected from clinical trials may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory
approval in the United States or elsewhere;
the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers
with which we contract for clinical and commercial supplies; and
the approval policies or regulations of the FDA may significantly change in a manner rendering our clinical data insufficient for approval.
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Failure to obtain regulatory approval for our product candidates for the foregoing, or any other reasons, will prevent us from commercializing our
product candidates, and our ability to generate sufficient revenue will be materially impaired. We cannot guarantee that regulators will agree with our
assessment of the results of the clinical trials we intend to conduct in the future or that such trials will be successful. The FDA and other regulators have
substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require
additional clinical trials, or pre-clinical or other studies. In addition, varying interpretations of the data obtained from pre-clinical and clinical testing could
delay, limit or prevent regulatory approval of our product candidates.
The process of obtaining regulatory approvals is expensive, often takes many years, if approval is obtained at all, and can vary substantially based
upon, among other things, the type, complexity and novelty of the product candidates involved, the jurisdiction in which regulatory approval is sought and the
substantial discretion of the regulatory authorities. Changes in regulatory approval policies during the development period, changes in or the enactment of
additional statutes or regulations, or changes in regulatory review for a submitted product application may cause delays in the approval or rejection of an
application. Regulatory approval obtained in one jurisdiction does not necessarily mean that a product candidate will receive regulatory approval in all
jurisdictions in which we may seek approval, but the failure to obtain approval in one jurisdiction may negatively impact our ability to seek approval in a
different jurisdiction. Failure to obtain regulatory marketing approval for our product candidates will prevent us from commercializing the product candidate,
and our ability to generate sufficient revenue will be materially impaired.
If the FDA does not conclude that our product candidates satisfy the requirements for the 505(b)(2) regulatory approval pathway, or if the requirements
for approval of any of our product candidates under Section 505(b)(2) are not as we expect, the approval pathway for our product candidates will likely
take significantly longer, cost significantly more and encounter significantly greater complications and risks than anticipated, and in any case may not be
successful .
We intend to seek FDA approval through the 505(b)(2) regulatory pathway for the majority of our product candidates. The Drug Price Competition
and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, added Section 505(b)(2) to the Federal Food, Drug and Cosmetic Act
(“FDCA”). Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies that were not
conducted by or for the applicant. If the FDA does not allow us to pursue the 505(b)(2) regulatory pathway for our product candidates as anticipated, we may
need to conduct additional clinical trials, provide additional data and information and meet additional standards for regulatory approval. If this were to occur,
the time and financial resources required to obtain FDA approval for our product candidates would likely substantially increase. Moreover, the inability to
pursue the 505(b)(2) regulatory pathway could result in new competitive products reaching the market faster than our product candidates, which could
materially adversely impact our competitive position and prospects. Even if we are allowed to pursue the 505(b)(2) regulatory pathway for a product
candidate, we cannot assure you that we will receive the requisite or timely approvals for commercialization of such product candidate. For example, we had
under development a patented injectable pentoxifylline therapeutic candidate, which we believed would satisfy the requirements of the 505(b)(2) regulatory
pathway. However, based on a pre-IND meeting with the FDA in March 2018 to discuss the clinical and regulatory pathway for the product, we have decided
to suspend all further development activities for this candidate indefinitely due to extraordinarily high costs of the clinical trials that would be required by the
FDA.
Notwithstanding the approval of many products by the FDA pursuant to Section 505(b)(2), over the last few years some pharmaceutical companies
and others have objected to the FDA’s interpretation of Section 505(b)(2) to allow reliance on the FDA’s prior findings of safety and effectiveness. If the FDA
changes its interpretation of Section 505(b)(2), or if the FDA’s interpretation is successfully challenged in court, this could delay or even prevent the FDA
from approving any Section 505(b)(2) application that we submit. In addition, we expect that our competitors will file citizens’ petitions with the FDA in an
attempt to persuade the FDA that our product candidate, or the clinical studies that support their approval, contain deficiencies. Such actions by our
competitors could delay or even prevent the FDA from approving any NDA that we submit under Section 505(b)(2).
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Moreover, the FDA recently adopted an interpretation of the three-year exclusivity provisions whereby a 505(b)(2) application can be blocked by
exclusivity even if does not rely on the previously approved drug that has exclusivity (or any safety or effectiveness information regarding that drug). Under
the FDA’s new interpretation, approval may be blocked by exclusivity awarded to a previously-approved drug product that shares certain innovative features
with our product, even if our 505(b)(2) application does not identify the previously-approved drug product as a listed drug or rely upon any of its safety or
efficacy data. Any failure to obtain regulatory approval of our product candidates would significantly limit our ability to generate sufficient revenues, and any
failure to obtain such approval for all of the indications and labeling claims we deem desirable could reduce our potential revenues.
An NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the
review or approval of our product candidate.
The 505(b)(2) application would enable us to reference published literature or the FDA’s previous findings of safety and effectiveness for the
branded reference drug. For NDAs submitted under Section 505(b)(2) of the FDCA, the patent certification and related provisions of the Hatch-Waxman Act
apply. In accordance with Hatch-Waxman Act, in seeking approval for a drug through such an NDA, applicants are required to list with the FDA each patent
whose claims cover the applicant’s product. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn, be
cited by potential generic competitors in support of approval of an ANDA. An ANDA provides for marketing of a drug product that has the same active
ingredients in the same strengths and dosage form as the listed drug and has been shown to be bioequivalent to the listed drug. Other than the requirement for
bioequivalence testing, ANDA applicants are not required to conduct, or submit results of, pre-clinical or clinical tests to prove the safety or effectiveness of
their drug product. Drugs approved in this way are commonly referred to as “generic equivalents” to the listed drug and can often be substituted by
pharmacists under prescriptions written for the original listed drug.
The ANDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book.
Specifically, the applicant must certify that either: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent
has not expired, but will expire on a particular date and approval is sought after patent expiration or (iv) the listed patent is invalid or will not be infringed by
the new product. The ANDA applicant may also elect to submit a section viii statement certifying that its proposed ANDA label does not contain (or carves
out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent. If the applicant does not challenge the listed
patents, the ANDA application will not be approved until all the listed patents claiming the referenced product have expired.
A certification that the new product will not infringe the already approved product’s listed patents, or that such patents are invalid or unenforceable,
is called a Paragraph IV certification. If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the
Paragraph IV certification to the NDA and patent holders once the ANDA has been accepted for filing by the FDA. The NDA and patent holders may then
initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. Under the Hatch-Waxman Act, the holder of patents that the
505 (b)(2) application references may file a patent infringement lawsuit after receiving notice of the Paragraph IV certification. Filing of a patent infringement
lawsuit against the filer of the 505(b)(2) applicant within 45 days of the patent owner’s receipt of notice triggers a one-time, automatic, 30-month stay of the
FDA’s ability to approve the 505(b)(2) NDA, unless patent litigation is resolved in favor of the Paragraph IV filer or the patent expires before that time.
Accordingly, we may invest a significant amount of time and expense in the development of one or more product candidates only to be subject to significant
delay and patent litigation before such product candidates may be commercialized, if at all.
In addition, a 505(b)(2) application will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new
chemical entity listed in the Orange Book for the referenced product has expired. The FDA may also require us to perform one or more additional clinical
studies or measurements to support the change from the branded reference drug, which could be time consuming and could substantially delay our
achievement of regulatory approvals for such product candidates. The FDA may also reject our future 505(b)(2) submissions and require us to file such
submissions under Section 505(b)(1) of the FDCA, which would require us to provide extensive data to establish safety and effectiveness of the drug for the
proposed use and could cause delay and be considerably more expensive and time consuming. These factors, among others, may limit our ability to
successfully commercialize our product candidates.
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Companies that produce branded reference drugs routinely bring litigation against ANDA or 505(b)(2) applicants that seek regulatory approval to
manufacture and market generic and reformulated forms of their branded products. These companies often allege patent infringement or other violations of
intellectual property rights as the basis for filing suit against an ANDA or 505(b)(2) applicant. Likewise, patent holders may bring patent infringement suits
against companies that are currently marketing and selling their approved generic or reformulated products. Litigation to enforce or defend intellectual
property rights is often complex and often involves significant expense and can delay or prevent introduction or sale of our product candidates. If patents are
held to be valid and infringed by our product candidates in a particular jurisdiction, we would, unless we could obtain a license from the patent holder, be
required to cease selling in that jurisdiction and may need to relinquish or destroy existing stock in that jurisdiction. There may also be situations where we
use our business judgment and decide to market and sell our approved products, notwithstanding the fact that allegations of patent infringement(s) have not
been finally resolved by the courts, which is known as an “at-risk launch.” The risk involved in doing so can be substantial because the remedies available to
the owner of a patent for infringement may include, among other things, damages measured by the profits lost by the patent owner and not necessarily by the
profits earned by the infringer. In the case of a willful infringement, the definition of which is subjective, such damages may be increased up to three times.
Moreover, because of the discount pricing typically involved with bioequivalent and, to a lesser extent, 505(b)(2) products, patented branded products
generally realize a substantially higher profit margin than bioequivalent and, to a lesser extent, 505(b)(2) products, resulting in disproportionate damages
compared to any profits earned by the infringer. An adverse decision in patent litigation could have a material adverse effect on our business, financial
position and results of operations and could cause the market value of our common stock to decline.
Even if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product, and the revenue
that we generate from its sales, if any, may be limited.
If approved for marketing, the commercial success of our product candidates will depend upon each product’s acceptance by the medical community,
including physicians, patients and health care payors. The degree of market acceptance for any of our product candidates will depend on a number of factors,
including:
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demonstration of clinical safety and efficacy;
relative convenience, dosing burden and ease of administration;
the prevalence and severity of any adverse effects;
the willingness of physicians to prescribe our product candidates, and the target patient population to try new therapies;
efficacy of our product candidates compared to competing products;
the introduction of any new products that may in the future become available targeting indications for which our product candidates may be
approved;
new procedures or therapies that may reduce the incidences of any of the indications in which our product candidates may show utility;
pricing and cost-effectiveness;
the inclusion or omission of our product candidates in applicable therapeutic and vaccine guidelines;
the effectiveness of our own or any future collaborators’ sales and marketing strategies;
limitations or warnings contained in approved labeling from regulatory authorities;
our ability to obtain and maintain sufficient third-party coverage and adequate reimbursement from government health care programs, including
Medicare and Medicaid, private health insurers and other third-party payors or to receive the necessary pricing approvals from government
bodies regulating the pricing and usage of therapeutics; and
the willingness of patients to pay out-of-pocket in the absence of third-party coverage or adequate reimbursement or government pricing
approvals.
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If any of our product candidates are approved, but do not achieve an adequate level of acceptance by physicians, health care payors, and patients, we
may not generate sufficient revenue and we may not be able to achieve or sustain profitability. Our efforts to educate the medical community and third-party
payors on the benefits of our product candidates may require significant resources and may never be successful.
In addition, even if we obtain regulatory approvals for our product candidates, the timing or scope of any approvals may prohibit or reduce our
ability to commercialize our product candidates successfully. For example, if the approval process takes too long, we may miss market opportunities and give
other companies the ability to develop competing products or establish market dominance. Any regulatory approval we ultimately obtain may be limited or
subject to restrictions or post-approval commitments that render our product candidates not commercially viable. For example, regulatory authorities may
approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for any of our
product candidates, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve any of our product candidates
with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that indication. Further, the FDA or
comparable foreign regulatory authorities may place conditions on approvals or require risk management plans or a Risk Evaluation and Mitigation Strategy
(“REMS”), to assure the safe use of the drug. If the FDA concludes a REMS is needed, the FDA will not approve the NDA without an approved REMS, if
required. A REMS could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods,
patient registries and other risk minimization tools. The FDA may also require a REMS for an approved product when new safety information emerges. Any
of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of our product candidates.
Moreover, product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following the initial marketing of the
product. Any of the foregoing scenarios could materially harm the commercial success of our product candidates.
We are subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product
candidates could be subject to labeling and other restrictions and withdrawal from the market and we may be subject to penalties if we fail to comply with
regulatory requirements or if we experience unanticipated problems with our product candidates.
The FDA or foreign equivalent may still impose significant restrictions on our products indicated uses or the conditions of approval, or impose
ongoing requirements for potentially costly and time-consuming post-approval studies, including Phase 4 clinical trials, and post-market surveillance to
monitor safety and efficacy. Our product candidates will also be subject to ongoing regulatory requirements governing the manufacturing, labeling,
packaging, storage, distribution, safety surveillance, advertising, promotion, recordkeeping and reporting of adverse events and other post-market
information. These requirements include registration with the FDA, as well as continued compliance with current Good Clinical Practices regulations
(“cGCPs”) for any clinical trials that we conduct post-approval. In addition, manufacturers of drug products and their facilities are subject to continual review
and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements relating to quality control, quality assurance
and corresponding maintenance of records and documents.
The FDA has the authority to require a REMS as part of an NDA or after approval, which may impose further requirements or restrictions on the
distribution or use of an approved drug, such as limiting prescribing to certain physicians or medical centers that have undergone specialized training, limiting
treatment to patients who meet certain safe-use criteria or requiring patient testing, monitoring and/or enrollment in a registry.
With respect to sales and marketing activities by us or any future partner, advertising and promotional materials must comply with FDA rules in
addition to other applicable federal, state and local laws in the United States and similar legal requirements in other countries. In the United States, the
distribution of product samples to physicians must comply with the requirements of the U.S. Prescription Drug Marketing Act. Application holders must
obtain FDA approval for product and manufacturing changes, depending on the nature of the change. We may also be subject, directly or indirectly through
our customers and partners, to various fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute, U.S. False Claims Act, and similar
state laws, which impact, among other things, our proposed sales, marketing and scientific/educational grant programs. If we participate in the U.S. Medicaid
Drug Rebate Program, the Federal Supply Schedule of the U.S. Department of Veterans Affairs, or other government drug programs, we will be subject to
complex laws and regulations regarding reporting and payment obligations. All of these activities are also potentially subject to U.S. federal and state
consumer protection and unfair competition laws. Similar requirements exist in many of these areas in other countries.
In addition, if any of our product candidates are approved for a particular indication, our product labeling, advertising and promotion would be
subject to regulatory requirements and continuing regulatory review. The FDA strictly regulates the promotional claims that may be made about prescription
products. In particular, a product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling. However,
companies may share truthful and not misleading information that is otherwise consistent with the product’s approved FDA labeling. If we receive marketing
approval for our product candidates, physicians may nevertheless legally prescribe our products to their patients in a manner that is inconsistent with the
approved label. If we are found to have promoted such off-label uses, we may become subject to significant liability and government fines. The FDA and
other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly
promoted off-label uses may be subject to significant sanctions. The federal government has levied large civil and criminal fines against companies for
alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into
consent decrees of permanent injunctions under which specified promotional conduct is changed or curtailed.
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If we or a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency,
problems with the facility where the product is manufactured, or we or our manufacturers fail to comply with applicable regulatory requirements, we may be
subject to the following administrative or judicial sanctions:
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restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product
recalls;
issuance of warning letters or untitled letters;
clinical holds;
injunctions or the imposition of civil or criminal penalties or monetary fines;
suspension or withdrawal of regulatory approval;
suspension of any ongoing clinical trials;
refusal to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of product license
approvals;
suspension or imposition of restrictions on operations, including costly new manufacturing requirements; or
product seizure or detention or refusal to permit the import or export of product.
The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue.
Adverse regulatory action, whether pre- or post-approval, can also potentially lead to product liability claims and increase our product liability exposure.
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Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs
for us and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in international
markets and/or to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product
candidates will be harmed.
We currently have a limited sales and marketing organization and one partner for co-promotion of our Biorphen product. If we are unable to secure a
sales and marketing partner for potential future products or establish satisfactory sales and marketing capabilities, we may not successfully
commercialize our product candidates.
We have limited sales and marketing personnel. In order to commercialize products that are approved for commercial sales, we must either
collaborate with third parties that have such commercial infrastructure or develop our own sales and marketing infrastructure. If we are not successful
entering into appropriate collaboration arrangements or recruiting sufficient sales and marketing personnel or in building a sales and marketing infrastructure,
we will have difficulty successfully commercializing our product candidates, which would adversely affect our business, operating results and financial
condition.
We may not be able to enter into additional collaboration agreements on terms acceptable to us or at all. In addition, even if we enter into such
relationships, we may have limited or no control over the sales, marketing and distribution activities of these third parties. Our future revenues may depend
heavily on the success of the efforts of these third parties. If we elect to establish a sales and marketing infrastructure, we may not realize a positive return on
this investment. In addition, we will have to compete with established and well-funded pharmaceutical and biotechnology companies to recruit, hire, train and
retain sales and marketing personnel. Factors that may inhibit our efforts to commercialize our product candidates without strategic partners or licensees
include:
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our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
the inability of sales personnel to obtain access to or educate an adequate number of physicians as to the benefits of any our product candidates;
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with
more extensive product lines; and
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and
affect the prices we may obtain.
In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding
the health care system that could prevent or delay marketing approval for our product candidates, restrict or regulate post-approval activities and affect our
ability to profitably sell our product candidates. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales
and promotional activities for pharmaceutical products. We do not know whether additional legislative changes will be enacted, or whether the FDA
regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any,
may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as
subject us to more stringent product labeling and post-marketing testing and other requirements.
In the United States, the Medicare Modernization Act (“MMA”) changed the way Medicare covers and pays for pharmaceutical products. The
legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new reimbursement methodology based on average sales prices
for drugs. In addition, this legislation authorized Medicare Part D prescription drug plans to use formularies where they can limit the number of drugs that
will be covered in any therapeutic class. As a result of this legislation and the expansion of federal coverage of drug products, we expect that there will be
additional pressure to contain and reduce costs. These cost reduction initiatives and other provisions of this legislation could decrease the coverage and price
that we receive for our product candidates and could seriously harm our business. While the MMA applies only to drug benefits for Medicare beneficiaries,
private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement
that results from the MMA may result in a similar reduction in payments from private payors.
In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively
referred to as the Health Care Reform Law, was enacted, which substantially changes the way health care is financed by both governmental and private
insurers, and significantly impacts the U.S. pharmaceutical industry. The Health Care Reform Law, among other things, imposed reporting requirements on
manufacturers related to drug samples and financial relationships with physicians and teaching hospitals, increased the minimum Medicaid rebates owed by
manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations,
established annual fees on manufacturers of certain branded prescription drugs, and established a Medicare Part D coverage gap discount program.
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Some of the provisions of the Health Care Reform Law have yet to be implemented, and there have been judicial and Congressional challenges to
certain aspects of the Health Care Reform Law, as well as recent efforts by the Trump administration to repeal or replace certain aspects of the Health Care
Reform Law. Since January 2017, President Trump has signed two executive orders and other directives designed to delay, circumvent or loosen certain
requirements mandated by the Health Care Reform Law. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part
of the Health Care Reform Law. While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes
under the Health Care Reform Law have been signed into law. The Tax Act included a provision which repealed, effective January 1, 2019, the tax-based
shared responsibility payment imposed by the Health Care Reform Law on certain individuals who fail to maintain qualifying health coverage for all or part
of a year that is commonly referred to as the “individual mandate.” On January 22, 2018, President Trump signed a continuing resolution on appropriations
for fiscal year 2018 that delayed the implementation of certain Health Care Reform Law-mandated fees, including the so-called “Cadillac” tax on certain high
cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise
tax on non-exempt medical devices. The Bipartisan Budget Act of 2018, among other things, amended the Health Care Reform, effective January 1, 2019, to
increase from 50% to 70% the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D and to close the
coverage gap in most Medicare drug plans, commonly referred to as the “donut hole”. On December 14, 2018, a Texas U.S. District Court Judge ruled that
the Health Care Reform is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Act. While the Texas
U.S. District Court Judge, as well as the Trump administration and CMS, have stated that the ruling will have no immediate effect pending appeal of the
decision, it is unclear how this decision, subsequent appeals, and other efforts to repeal and replace the Health Care Reform will impact the ACA and our
business. We cannot predict the impact on our business of changes to current laws and regulations. However, any changes that lower reimbursements for
products for which we may obtain regulatory approval, or that impose administrative and financial burdens on us, could adversely affect our business.
In addition, other legislative changes have been proposed and adopted in the United States since the Health Care Reform Law was enacted. These
changes include, among others, aggregate reductions of Medicare payments to providers of up to 2% per fiscal year. We expect that additional state and
federal health care reform measures will be adopted in the future, which may alter or completely replace the existing health care financing structure. Any of
these reform measures could limit the amounts that federal and state governments will pay for health care products and services, which could result in reduced
demand for any such product candidate that we may have developed or additional pricing pressures on our business.
Further, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of
prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation
designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and
reform government program reimbursement methodologies for products. For example, the Trump administration released a “Blueprint” to lower drug prices
and reduce out of pocket costs of drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of certain
federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by
consumers. On January 31, 2019, the U.S. Department of Health and Human Services, Office of Inspector General, proposed modifications to the federal
Anti-Kickback Statute discount safe harbor for the purpose of reducing the cost of drug products to consumers which, among other things, if finalized, will
affect discounts paid by manufacturers to Medicare Part D plans, Medicaid managed care organizations and pharmacy benefit managers working with these
organizations. While some of these and other proposed measures may require additional authorization to become effective, Congress and the Trump
administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.
The policies of the FDA or similar regulatory authorities may change, and additional government regulations may be enacted that could prevent,
limit or delay regulatory approval of our product candidates. For example, in December 2016, the 21st Century Cures Act was signed into law. The 21st
Century Cures Act, among other things, is intended to modernize the regulation of drugs and biologics and spur innovation, but it has not yet been fully
implemented and its ultimate implementation is unclear. Furthermore, the Trump administration has taken several executive actions, including the issuance of
a number of executive orders, that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and
oversight activities such as implementing statutes through rulemaking, issuance of guidance and review and approval of marketing applications. If these
executive actions impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be
negatively impacted. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not
able to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or
sustain profitability, which would adversely affect our business.
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Our future growth may depend, in part, on our ability to penetrate international markets, where we would be subject to additional regulatory burdens and
other risks and uncertainties.
Our future profitability may depend, in part, on our ability to commercialize our product candidates in international markets for which we intend to
rely on collaborations with third parties. If we commercialize any of our product candidates in international markets, we would be subject to additional risks
and uncertainties, including:
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our customers’ ability to obtain reimbursement for our product candidates in international markets;
our inability to directly control commercial activities because we are relying on third parties;
the burden of complying with complex and changing international regulatory, tax, accounting and legal requirements;
different medical practices and customs in foreign countries affecting acceptance in the marketplace;
differing payor reimbursement regimes, governmental payors or patient self-pay systems and price controls
import or export licensing requirements;
longer accounts receivable collection times;
longer lead times for shipping;
language barriers for technical training;
reduced protection of intellectual property rights in some foreign countries;
foreign currency exchange rate fluctuations; and
the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.
International sales of our product candidates could also be adversely affected by the imposition of governmental controls, political and economic
instability, trade restrictions and changes in tariffs, any of which may adversely affect our results of operations.
If we market Biorphen or any of our product candidates in a manner that violates health care fraud and abuse laws, or if we violate government price
reporting laws, we may be subject to civil or criminal penalties.
The FDA enforces laws and regulations, which require that the promotion of pharmaceutical products be consistent with the approved prescribing
information. While physicians may prescribe an approved product for a so-called “off label” use, it is unlawful for a pharmaceutical company to promote its
products in a manner that is inconsistent with its approved label and any company which engages in such conduct can be subject to significant liability.
Similarly, industry codes in the EU and other foreign jurisdictions prohibit companies from engaging in off-label promotion and regulatory agencies in
various countries enforce violations of the code with civil penalties. While we intend to ensure that our promotional materials are consistent with our label,
regulatory agencies may disagree with our assessment and may issue untitled letters, warning letters or may institute other civil or criminal enforcement
proceedings. In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal health care fraud and abuse
laws have been applied in recent years to restrict certain marketing practices in the pharmaceutical industry. These laws include, among others, the U.S. Anti-
Kickback Statute, U.S. False Claims Act and similar state laws. Because of the breadth of these laws and the narrowness of their exceptions and safe harbors,
it is possible that some of our business activities could be subject to challenge under one or more of these laws.
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The U.S. Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to
induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any health care item or service reimbursable under
Medicare, Medicaid or other federally financed health care programs. This statute has been interpreted broadly to apply to arrangements between
pharmaceutical manufacturers on the one hand and prescribers, purchasers, formulary managers, and others on the other hand. Although there are several
statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution, the exceptions and safe harbors are drawn narrowly,
and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an
exception or safe harbor. Our practices may not, in all cases, meet all of the criteria for safe harbor protection from anti-kickback liability. Moreover, recent
health care reform legislation has strengthened these laws. For example, the Health Care Reform Law, among other things, amended the intent requirement of
the U.S. Anti-Kickback Statute and other criminal health care fraud statutes; a person or entity no longer needs to have actual knowledge of the statutes or
specific intent to violate them in order to have committed a violation. In addition, the Health Care Reform Law provides that the government may assert that a
claim including items or services resulting from a violation of the U.S. Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the U.S.
False Claims Act. Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the
federal government or knowingly making, or causing to be made, a false statement to get a false claim paid.
Over the past few years, several pharmaceutical and other health care companies have been prosecuted under these laws for a variety of alleged
promotional and marketing activities, such as: allegedly providing free trips, free goods, sham consulting fees and grants and other monetary benefits to
prescribers; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in
off-label promotion that caused claims to be submitted to Medicare or Medicaid for non-covered, off-label uses; and submitting inflated best price
information to the Medicaid Rebate Program to reduce liability for Medicaid rebates. Most states also have statutes or regulations similar to the U.S. Anti-
Kickback Statute and the U.S. False Claims Act, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states,
apply regardless of the payor. Sanctions under these federal and state laws may include significant administrative, criminal, and civil monetary penalties,
exclusion of a manufacturer’s products from reimbursement under government programs, fines and imprisonment.
We will be completely dependent on third parties to manufacture our product candidates, and our commercialization of our product candidates could be
halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA or comparable foreign regulatory
authorities, fail to provide us with sufficient quantities of our product candidates or fail to do so at acceptable quality levels or prices .
We do not currently have, nor do we plan to acquire, the capability or infrastructure to manufacture the active pharmaceutical ingredient (“API”) in
our product candidates for use in our clinical trials or for commercial product, if any. In addition, we do not have the capability to encapsulate any of our
product candidates as a finished drug product for commercial distribution. As a result, we will be obligated to rely on contract manufacturers, if and when any
of our product candidates are approved for commercialization. While we have entered into certain agreements with contract manufacturers for clinical and
commercial supply, there can be no assurance we will be able to maintain those relationships or engage additional contract manufacturers for clinical or
commercial supply of any of our product candidates on favorable terms to us, or at all.
The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the FDA or comparable foreign
regulatory authorities pursuant to inspections that will be conducted after we submit an NDA to the FDA or their equivalents to other relevant regulatory
authorities. We will not control the manufacturing process of, and will be completely dependent on, our contract manufacturing partners for compliance with
cGMPs for manufacture of both active drug substances and finished drug products. These cGMP regulations cover all aspects of the manufacturing, testing,
quality control and record keeping relating to our product candidates. If our contract manufacturers do not successfully manufacture material that conforms to
our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure or maintain regulatory approval for their
manufacturing facilities. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product
candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our
ability to develop, obtain regulatory approval for or market our product candidates, if approved.
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Our contract manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies
for compliance with cGMPs and similar regulatory requirements. We will not have control over our contract manufacturers’ compliance with these
regulations and standards. Failure by any of our contract manufacturers to comply with applicable regulations could result in sanctions being imposed on us,
including fines, injunctions, civil penalties, failure to grant approval to market any of our product candidates, delays, suspensions or withdrawals of approvals,
operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our business. In addition, we will not have control over
the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Failure by our contract
manufacturers to comply with or maintain any of these standards could adversely affect our ability to develop, obtain regulatory approval for or market any of
our product candidates.
If, for any reason, these third parties are unable or unwilling to perform, we may not be able to terminate our agreements with them, and we may not
be able to locate alternative manufacturers or formulators or enter into favorable agreements with them and we cannot be certain that any such third parties
will have the manufacturing capacity to meet future requirements. If these manufacturers or any alternate manufacturer of finished drug product experiences
any significant difficulties in its respective manufacturing processes for our API or finished products or should cease doing business with us, we could
experience significant interruptions in the supply of any of our product candidates or may not be able to create a supply of our product candidates at all. Were
we to encounter manufacturing issues, our ability to produce a sufficient supply of any of our product candidates might be negatively affected. Our inability to
coordinate the efforts of our third-party manufacturing partners, or the lack of capacity available at our third-party manufacturing partners, could impair our
ability to supply any of our product candidates at required levels. Because of the significant regulatory requirements that we would need to satisfy in order to
qualify a new bulk or finished product manufacturer, if we face these or other difficulties with our current manufacturing partners, we could experience
significant interruptions in the supply of any of our product candidates if we decided to transfer the manufacture of any of our product candidates to one or
more alternative manufacturers in an effort to deal with the difficulties.
Any manufacturing problem or the loss of a contract manufacturer could be disruptive to our operations and result in lost sales. Additionally, we rely
on third parties to supply the raw materials needed to manufacture our potential products. Any reliance on suppliers may involve several risks, including a
potential inability to obtain critical materials and reduced control over production costs, delivery schedules, reliability and quality. Any unanticipated
disruption to a contract manufacturer caused by problems at suppliers could delay shipment of Biorphen or any of our product candidates, increase our cost of
goods sold and result in lost sales.
We cannot guarantee that our future manufacturing and supply partners will be able to reduce the costs of commercial scale manufacturing of any of
our product candidates over time. If the commercial-scale manufacturing costs of any of our product candidates are higher than expected, these costs may
significantly impact our operating results. In order to reduce costs, we may need to develop and implement process improvements. However, in order to do
so, we will need, from time to time, to notify or make submissions with regulatory authorities, and the improvements may be subject to approval by such
regulatory authorities. We cannot be sure that we will receive these necessary approvals or that these approvals will be granted in a timely fashion. We also
cannot guarantee that we will be able to enhance and optimize output in our commercial manufacturing process. If we cannot enhance and optimize output,
we may not be able to reduce our costs over time.
We may not be able to establish agreements with third parties with whom we wish to collaborate and, if we are able to establish them, we may not be able
to establish them on commercially reasonable terms, which could result in alterations or delays of our development and commercialization plans.
We face significant competition in seeking appropriate third parties. Whether we reach a definitive agreement will depend, among other things, upon
our assessment of the third parties’ resources and expertise, the terms and conditions of the proposed agreement, and the proposed parties’ evaluation of a
number of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA or similar regulatory authorities
outside the United States, the potential market for the product candidate, the costs and complexities of manufacturing and delivering the product candidate to
patients, the potential of competing products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge
to such ownership without regard to the merits of the challenge and industry and market conditions generally. Potential third parties may also consider
alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more
attractive than the one with us for our product candidate. The terms of any arrangements that we may establish may also not be favorable to us.
Agreements with third parties are complex and time-consuming to negotiate and document. In addition, there have been a significant number of
recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future third parties. We may not be
able to negotiate agreements on a timely basis, on acceptable terms or at all. If we are unable to do so, we may have to curtail the development of the product
candidate, reduce or delay its development program, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase
our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development
or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do
not have sufficient funds, we may not be able to further develop our product candidate or bring it to market and generate product revenue.
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In addition, any future agreements that we enter into may not be successful. The success of our arrangements will depend heavily on the efforts and
activities of our third-party collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to
these collaborations. Disagreements between parties to an agreement regarding clinical development and commercialization matters can lead to delays in the
development process or commercializing the applicable product candidate and, in some cases, termination of the agreement. These disagreements can be
difficult to resolve if neither of the parties has final decision-making authority. Collaborations with pharmaceutical or biotechnology companies and other
third parties often are terminated or allowed to expire by the other party. Any such termination or expiration would adversely affect us financially and could
harm our business reputation.
We expect to rely on third parties to conduct clinical trials for our product candidates. If these third parties do not successfully carry out their contractual
duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize any of our product candidates and our business
would be substantially harmed.
We have entered into agreements with third-party CROs to conduct and manage our clinical programs including contracting with clinical sites to
perform our clinical studies. We plan to rely heavily on these parties for execution of clinical studies for our product candidates and will control only certain
aspects of their activities. Nevertheless, we will be responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol,
legal, regulatory and scientific standards, and our reliance on CROs and clinical sites will not relieve us of our regulatory responsibilities. We and our CROs
will be required to comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for any
products in clinical development. The FDA and its foreign equivalents enforce these cGCP regulations through periodic inspections of trial sponsors,
principal investigators and trial sites. If we or our CROs fail to comply with applicable cGCPs, 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, the FDA or other regulatory authorities will determine that any of our clinical trials comply with
cGCPs. In addition, our clinical trials must be conducted with products produced under cGMP regulations and will require a large number of test subjects.
Our failure or the failure of our CROs or clinical sites to comply with these regulations may require us to repeat clinical trials, which would delay the
regulatory approval process and could also subject us to enforcement action up to and including civil and criminal penalties.
Although we intend to design the clinical trials for our product candidates in consultation with CROs, we expect that the CROs will manage all of
the clinical trials conducted at contracted clinical sites. As a result, many important aspects of our drug development programs would be outside of our direct
control. In addition, the CROs and clinical sites may not perform all of their obligations under arrangements with us or in compliance with regulatory
requirements. If the CROs or clinical sites do not perform clinical trials in a satisfactory manner, breach their obligations to us or fail to comply with
regulatory requirements, the development and commercialization of any of our product candidates for the subject indication may be delayed or our
development program materially and irreversibly harmed. We cannot control the amount and timing of resources these CROs and clinical sites will devote to
our program or any of our product candidates. If we are unable to rely on clinical data collected by our CROs, we could be required to repeat, extend the
duration of, or increase the size of our clinical trials, which could significantly delay commercialization and require significantly greater expenditures.
If any of our relationships with these third-party CROs or clinical sites terminate, we may not be able to enter into arrangements with alternative
CROs or clinical sites. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or
if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for
other reasons, any such 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 financial results and the commercial prospects for any of our product candidates would be harmed, our
costs could increase and our ability to generate revenue could be delayed.
We enter into various contracts in the normal course of our business, some or all of which may require us to indemnify the other party to the contract. In
the event we have to perform under these indemnification provisions, it could have an adverse effect on our business, financial condition and results of
operations.
In the normal course of business, we periodically may enter into commercial, service, collaboration, licensing, consulting and other agreements that
contain indemnification provisions. With respect to our commercial agreements, vendors typically ask for indemnification from any third-party product
liability claims that could result from the production, use or consumption of the product, as well as for alleged infringements of any patent or other intellectual
property right by a third party. Should our obligation under an indemnification provision exceed applicable insurance coverage or if we were denied insurance
coverage, our business, financial condition and results of operations could be adversely affected. Similarly, if we are relying on a third party to indemnify us
and the party is denied insurance coverage, or the indemnification obligation exceeds the applicable insurance coverage and does not have other assets
available to indemnify us, our business, financial condition and results of operations could be adversely affected.
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Our Chief Executive Officer holds ownership interest in some of the third parties we have entered into agreements with. The terms and fee arrangements
of these agreements, we believe, approximate the terms and fee arrangements of an agreement that would have been obtained in an arm’s length and
unaffiliated transaction. Nonetheless, this may expose us to claims of interested transactions and other fiduciary suits.
Our Chief Executive Officer, Sean Brynjelsen, has a material ownership interest in several companies from which we have licensed or acquired
product development and marketing rights. These include a 27% stake in Andersen Pharma, LLC (license for DS-100), 33% stake in Eyemax, LLC (license
for EM-100) and 50% stake in Selenix, LLC (license for DS-200). We are required to pay these parties licensing fees, milestone payments and royalty
payments. We believe the terms of the transactional agreements, including the licensing fees, milestone payments and royalty payments, approximate the
terms and payments we could have obtained in an arms’ length transaction with an unaffiliated party. Nonetheless, a stockholder may seek to challenge these
agreements on grounds that they are not in the best interest of our company and our board breached its fiduciary duty by approving such agreements.
Any termination or suspension of, or delays in the commencement or completion of, any necessary studies of any of our product candidates for any
indications could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
The commencement and completion of clinical studies can be delayed for a number of reasons, including delays related to:
● the FDA or a comparable foreign regulatory authority failing to grant permission to proceed and placing the clinical study on hold;
● subjects for clinical testing failing to enroll or remain in our trials at the rate we expect;
● a facility manufacturing any of our product candidates being ordered by the FDA or other government or regulatory authorities to temporarily or
permanently shut down due to violations of cGMP requirements or other applicable requirements, or cross-contaminations of product candidates
in the manufacturing process;
● any changes to our manufacturing process that may be necessary or desired;
● subjects choosing an alternative treatment for the indications for which we are developing our product candidates, or participating in competing
clinical studies;
● subjects experiencing severe or unexpected drug-related adverse effects;
● reports from clinical testing on similar technologies and products raising safety and/or efficacy concerns;
● third-party clinical investigators losing their license or permits necessary to perform our clinical trials, not performing our clinical trials on our
anticipated schedule or employing methods consistent with the clinical trial protocol, cGMP requirements, or other third parties not performing
data collection and analysis in a timely or accurate manner;
● inspections of clinical study sites by the FDA, comparable foreign regulatory authorities, or IRBs finding regulatory violations that require us to
undertake corrective action, result in suspension or termination of one or more sites or the imposition of a clinical hold on the entire study, or
that prohibit us from using some or all of the data in support of our marketing applications;
● third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for
violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or any of
the data produced by such contractors in support of our marketing applications;
● one or more IRBs refusing to approve, suspending or terminating the study at an investigational site, precluding enrollment of additional
subjects, or withdrawing its approval of the trial; reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the
terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
● deviations of the clinical sites from trial protocols or dropping out of a trial;
● adding new clinical trial sites;
● the inability of the CRO to execute any clinical trials for any reason; and
● government or regulatory delays or “clinical holds” requiring suspension or termination of a trial.
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Product development costs for any of our product candidates will increase if we have delays in testing or approval or if we need to perform more or
larger clinical studies than planned. Additionally, changes in regulatory requirements and policies may occur and we may need to amend study protocols to
reflect these changes. Amendments may require us to resubmit our study protocols to the FDA, comparable foreign regulatory authorities, and IRBs for
reexamination, which may impact the costs, timing or successful completion of that study. If we experience delays in completion of, or if we, the FDA or
other regulatory authorities, the IRB, or other reviewing entities, or any of our clinical study sites suspend or terminate any of our clinical studies of any of
our product candidates, its commercial prospects may be materially harmed and our ability to generate sufficient product revenues will be delayed. Any
delays in completing our clinical trials will increase our costs, slow down our development and approval process and jeopardize our ability to generate
sufficient revenues. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that
cause, or lead to, termination or suspension of, or a delay in the commencement or completion of, clinical studies may also ultimately lead to the denial of
regulatory approval of our product candidates. In addition, if one or more clinical studies are delayed, our competitors may be able to bring products to
market before we do, and the commercial viability of any of our product candidates could be significantly reduced.
Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be
predictive of future trial results.
Clinical testing of drug product candidates is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can
occur at any time during the clinical trial process. The results of pre-clinical studies and early clinical trials may not be predictive of the results of later-stage
clinical trials. We cannot assure you that the FDA or comparable foreign regulatory authorities will view the results as we do or that any future trials of any of
our product candidates will achieve positive results. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits
despite having progressed through pre-clinical studies and initial clinical trials. A number of companies in the biopharmaceutical industry have suffered
significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Any future
clinical trial results for our product candidates may not be successful.
In addition, a number of factors could contribute to a lack of favorable safety and efficacy results for any of our product candidates. For example,
such trials could result in increased variability due to varying site characteristics, such as local standards of care, differences in evaluation period and surgical
technique, and due to varying patient characteristics including demographic factors and health status.
We have not conducted clinical trials for any of our product candidates, other than a bioequivalence trial for one product candidate, and we may be
delayed in commercializing or fail to find success in these trials. Further, the results of any clinical trial may not be predictive of future trial results. Positive
results in preclinical testing and early clinical trials do not ensure that later clinical trials will be successful. A number of pharmaceutical companies have
suffered significant setbacks in clinical trials, including in Phase 3, after promising results in preclinical testing and early clinical trials. These setbacks have
included negative safety and efficacy observations in later clinical trials, including previously unreported adverse events.
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To date, we have not conducted any clinical trials other than a Phase 3 bioequivalence trial for our EM-100 product candidate. Our clinical trials may
not be successful, and even if they are, the FDA may not approve our NDA for products that are successful in the trial, may not agree that the benefits
outweigh its risks, or may raise new concerns regarding our clinical trial designs. The Phase 3 trial process is often long, complex, costly and uncertain, and
delays or failure are common.
Phase 3 clinical trials often produce unsatisfactory results even though prior clinical trials were successful. Moreover, the results of clinical trials
may be unsatisfactory to the FDA or foreign regulatory authorities even if we believe those clinical trials to be successful. The FDA or applicable foreign
regulatory agencies may suspend one or all of our clinical trials or require that we conduct additional clinical, nonclinical, manufacturing, validation or drug
product quality studies and submit that data before considering or reconsidering any NDA or similar foreign regulatory application we may submit.
Depending on the extent of these additional studies, approval of any applications that we submit may be significantly delayed or may require us to expend
more resources than we have available. It is also possible that additional studies we conduct may not be considered sufficient by the FDA or applicable
foreign regulatory agencies to provide regulatory approval.
If any of these outcomes occur, we may not receive approval for our product candidate.
Third-party coverage and reimbursement and health care cost containment initiatives and treatment guidelines may constrain our future revenues.
Our ability to successfully market Biorphen and our product candidates will depend in part on the coverage and level of reimbursement that
government health administration authorities, private health coverage insurers and other organizations provide for the cost of our products and related
treatments. Countries in which any of our product candidates are sold through reimbursement schemes under national health insurance programs frequently
require that manufacturers and sellers of pharmaceutical products obtain governmental approval of initial prices and any subsequent price increases. In certain
countries, including the United States, government-funded and private medical care plans can exert significant indirect pressure on prices. Increasingly, third-
party payors attempt to contain health care costs in ways that are likely to impact our development of products, including:
● failing to approve or challenging the prices charged for health care products;
● introducing reimportation schemes from lower priced jurisdictions;
● limiting both coverage and the amount of reimbursement for new therapeutic products;
● denying or limiting coverage for products that are approved by the regulatory agencies but are considered to be experimental or investigational
by third-party payors; and
● refusing to provide coverage when an approved product is used in a way that has not received regulatory marketing approval.
We may not be able to sell Biorphen or our product candidates profitably if adequate prices are not approved or coverage and reimbursement is
unavailable or limited in scope.
We are subject to extensive laws and regulations related to data privacy, and our failure to comply with these laws and regulations could harm our
business.
We are subject to laws and regulations governing data privacy and the protection of personal information. These laws and regulations govern our
processing of personal data, including the collection, access, use, analysis, modification, storage, transfer, security breach notification, destruction and
disposal of personal data. There are foreign and state law versions of these laws and regulations to which we are currently and/or may in the future, be
subject. For example, the collection and use of personal health data in the European Union is governed by the GDPR. The GDPR, which is wide-ranging in
scope, imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals,
the security and confidentiality of the personal data, data breach notification and the use of third-party processors in connection with the processing of
personal data. The GDPR also imposes strict rules on the transfer of personal data out of the European Union to the United States, provides an enforcement
authority and imposes large monetary penalties for noncompliance. The GDPR requirements apply not only to third-party transactions, but also to transfers of
information within our company, including employee information. In addition, in 2018 California adopted a new privacy law that became effective on January
1, 2020, which borrows heavily from the GDPR. The GDPR and similar data privacy laws of other jurisdictions place significant responsibilities on us and
create potential liability in relation to personal data that we or our third-party service providers process, including in clinical trials conducted in the United
States and the European Union. In addition, we expect that there will continue to be new proposed laws, regulations and industry standards relating to privacy
and data protection in the United States, the European Union and other jurisdictions, and we cannot determine the impact such future laws, regulations and
standards may have on our business.
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Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. A severe or
prolonged global economic downturn could result in a variety of risks to our business, including our ability to raise additional capital when needed on
acceptable terms, if at all. This is particularly true in Europe, which is undergoing a continued severe economic crisis. A weak or declining economy could
also strain our suppliers, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in
which the current economic climate and financial market conditions could adversely impact our business.
The United Kingdom’s referendum to leave the European Union or “Brexit,” has and may continue to cause disruptions to capital and currency
markets worldwide. The full impact of the Brexit decision, however, remains uncertain. A process of negotiation will determine the future terms of the United
Kingdom’s relationship with the European Union. During this period of negotiation, our results of operations and access to capital may be negatively affected
by interest rate, exchange rate and other market and economic volatility, as well as regulatory and political uncertainty. Brexit may also have a detrimental
effect on our suppliers and manufacturers, which would, in turn, adversely affect our financial condition.
Risks Relating to Our Intellectual Property Rights
We will depend on rights to certain pharmaceutical compounds that have been acquired by us. We do not have complete control over these
pharmaceutical compounds and any loss of our rights to them could prevent us from selling our products.
We are dependent on the assignment and licensing from third parties for certain of our pharmaceutical compounds and potential product candidates.
Our rights to use the pharmaceutical compounds we were assigned are subject to the negotiation of, continuation of and compliance with the terms of those
assignments and licenses. Moreover, under these agreements, any related patents may remain under the control of the assignor or licensor. Our rights to
develop and commercialize the product candidates are subject to the validity of the intellectual property rights. Enforcement of any assigned or licensed
patents or defense or any claims asserting the invalidity of these patents is often subject to the control or cooperation of the assignor or licensor. Legal action
could be initiated against the original owners of the intellectual property that we acquired and an adverse outcome in such legal action could harm our
business because it might prevent such companies or institutions from continuing to assign intellectual property that we may need to operate our business.
In addition, our rights to practice the inventions claimed in any patents and patent applications are subject to our assignors and licensors abiding by
the terms of those agreements and not terminating them. These agreements may be terminated by the assignor or licensor if we are in material breach of
certain terms or conditions of the agreement or in certain other circumstances. Our rights under these agreements are subject to our continued compliance
with the terms of the agreements, including the payment of royalties and other payment due under the agreements. Termination of these agreements could
prevent us from marketing some or all of our products. Because of the complexity of our products and the patents, determining the scope of the assignment or
license and related royalty obligations can be difficult and can lead to disputes between us and the assignor or licensor. An unfavorable resolution of such a
dispute could lead to an increase in the royalties payable pursuant to the agreement. If the assignor or licensor believed we were not paying the royalties due
under the agreement or were otherwise not in compliance with the terms of the agreement, the assignor or licensor might attempt to revoke the agreement. If
such an attempt were successful, we might be barred from producing and selling some or all of our products.
It is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights.
Our commercial success will depend, in part, on obtaining and maintaining patent protection for our technologies, products and processes,
successfully defending these patents against third-party challenges and successfully enforcing these patents against third party competitors. Our development
partner has filed a patent application for ET-104. In addition, our development partner for ET-105 was granted a patent by the United States Patent and
Trademark office. The patent positions of pharmaceutical companies can be highly uncertain and involve complex legal, scientific and factual questions for
which important legal principles remain unresolved. Changes in either the patent laws or in interpretations of patent laws may diminish the value of our
intellectual property. Accordingly, we cannot predict the breadth of claims that may be allowable or enforceable in our patents. Patent and patent applications
relating to our product candidates and related technologies may be challenged, invalidated or circumvented by third parties and might not protect us against
competitors with similar products or technologies.
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The degree of future protection for our proprietary rights is uncertain, because legal means afford only limited protection and may not adequately
protect our rights, permit us to gain or keep our competitive advantage, or provide us with any competitive advantage at all. For example, others have filed,
and in the future are likely to file, patent applications covering products and technologies that are similar, identical or competitive to any of our product
candidates, or important to our business. We cannot be certain that any patent application owned by a third party will not have priority over patent
applications filed by us, or that we will not be involved in interference, opposition or invalidity proceedings before U.S. or foreign patent offices.
Additionally, if we or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering any product
candidate, the defendant could counterclaim that the patent covering any other product candidate is invalid and/or unenforceable. In patent litigation in the
United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge include alleged failures
to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for unenforceability assertions include
allegations that someone connected with prosecution of the patent withheld relevant information from the U.S. Patent and Trademark Office (“U.S. PTO”), or
made a misleading statement, during prosecution. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even
outside the context of litigation. Such mechanisms include re-examination, post grant review and equivalent proceedings in foreign jurisdictions, e.g.
opposition proceedings. Such proceedings could result in revocation or amendment of our patents or our licensors’ patents in such a way that they no longer
cover product candidates or competitive products. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to
validity, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a
defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on any
product candidate. Such a loss of patent protection would have a material adverse impact on our business.
In the future, we may rely on know-how and trade secrets to protect technology, especially in cases when we believe patent protection is not
appropriate or obtainable. However, know-how and trade secrets are difficult to protect. While we intend to require employees, academic collaborators,
consultants and other contractors to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or other proprietary or
licensed information. Typically, research collaborators and scientific advisors have rights to publish data and information in which we may have rights. If we
cannot maintain the confidentiality of our proprietary technology and other confidential information, our ability to receive patent protection and our ability to
protect valuable information owned by us may be imperiled. Enforcing a claim that a third-party entity illegally obtained and is using any of our trade secrets
is expensive and time consuming, and the outcome is unpredictable. In addition, courts are sometimes less willing to protect trade secrets than patents.
Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
We may not be able to protect our intellectual property rights throughout the world.
Filing, prosecuting and defending patents on product candidates in all countries and jurisdictions throughout the world would be prohibitively
expensive, and our intellectual property rights in some countries outside the United States could be less extensive than those offered in the United States.
Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or
importing products made using our inventions in and into the United States or other jurisdictions.
Competitors may use our technologies in jurisdictions where we do not have, or where we do not pursue and obtain, patent protection to develop
their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as
that in the United States. These products may compete with our product and our patents or other intellectual property rights may not be effective or sufficient
to prevent them from competing. Even if we pursue and obtain issued patents in particular jurisdictions, our patent claims or other intellectual property rights
may not be effective or sufficient to prevent third parties from so competing.
Further, the laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many
companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. The legal systems of
some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property protection, especially those relating
to biotechnology. This could make it difficult for us to stop the infringement of our patents, if obtained, or the misappropriation of our other intellectual
property rights. For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. In
addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries,
patents may provide limited or no benefit. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time-
consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit
of patent protection in such countries.
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Moreover, proceedings to enforce our patent rights, or those of our licensors or partners, in foreign jurisdictions could result in substantial costs and
divert our efforts and attention from other aspects of our business, could put our in-licensed patents, or any patents that we may own in the future, at risk of
being invalidated or interpreted narrowly, could put our owned or in-licensed patent applications at risk of not issuing and could provoke third parties to assert
claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially
meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial
advantage from the intellectual property that we develop or license.
If we fail to obtain or maintain patent protection or trade secret protection for our product candidates or our technologies, third parties could use our
proprietary information, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and attain profitability.
We may also rely on the trademarks we may develop to distinguish our products from the products of our competitors. We cannot guarantee that any
trademark applications filed by us or our business partners will be approved. Third parties may also oppose such trademark applications, or otherwise
challenge our use of the trademarks. In the event that the trademarks we use are successfully challenged, we could be forced to rebrand our products, which
could result in loss of brand recognition, and could require us to devote resources to advertising and marketing new brands. Further, we cannot provide
assurance that competitors will not infringe the trademarks we use, or that we will have adequate resources to enforce these trademarks.
Changes in either U.S. or foreign patent law or interpretation of such laws could diminish the value of patents in general, thereby impairing our ability to
protect our products.
As is the case with other biotechnology companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and
enforcing patents in the biotechnology industry involve both technological and legal complexity, and it therefore is costly, time-consuming and inherently
uncertain. In addition, on September 16, 2011, the Leahy-Smith America Invents Act (“AIA”), was signed into law. The AIA includes a number of significant
changes to U.S. patent law, including provisions that affect the way patent applications will be prosecuted and may also affect patent litigation.
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 in the U.S. PTO 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. This will require us to be cognizant going forward of the time from invention to filing of a patent application.
Among some of the other changes introduced by the AIA are changes that limit where a patentee may file a patent infringement suit and providing
opportunities for third parties to challenge any issued patent in the U.S. PTO. This applies 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 the U.S. PTO proceedings compared to the evidentiary standard in U.S.
federal court, a third party could potentially provide evidence in a U.S. PTO proceeding sufficient for the U.S. PTO 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 U.S.
PTO 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, the federal courts, the U.S. PTO, 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 or to enforce our existing in-licensed
patents and patents that we might obtain in the future.
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Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and
commercialization efforts.
Our success depends in part on avoiding infringement of the proprietary technologies of others. The pharmaceutical industry has been characterized
by frequent litigation regarding patent and other intellectual property rights. Identification of third-party patent rights that may be relevant to our proprietary
technology is difficult because patent searching is imperfect due to differences in terminology among patents, incomplete databases and the difficulty in
assessing the meaning of patent claims. Additionally, because patent applications are maintained in secrecy until the application is published, we may be
unaware of third-party patents that may be infringed by commercialization of any of our product candidates or any future product candidate. There may be
certain issued patents and patent applications claiming subject matter that we may be required to license in order to research, develop or commercialize any of
our product candidates, and we do not know if such patents and patent applications would be available to license on commercially reasonable terms, or at all.
Any claims of patent infringement asserted by third parties would be time-consuming and may:
● result in costly litigation;
● divert the time and attention of our technical personnel and management;
● prevent us from commercializing a product until the asserted patent expires or is held finally invalid or not infringed in a court of law;
● require us to cease or modify our use of the technology and/or develop non-infringing technology; or
● require us to enter into royalty or licensing agreements.
Third parties may hold proprietary rights that could prevent any of our product candidates from being marketed. Any patent-related legal action
against us claiming damages and seeking to enjoin commercial activities relating to any of our product candidates or our processes could subject us to
potential liability for damages and require us to obtain a license to continue to manufacture or market any of our product candidates or any future product
candidates. We cannot predict whether we would prevail in any such actions or that any license required under any of these patents would be made available
on commercially acceptable terms, if at all. In addition, we cannot be sure that we could redesign our product candidates or any future product candidates or
processes to avoid infringement, if necessary. Accordingly, an adverse determination in a judicial or administrative proceeding, or the failure to obtain
necessary licenses, could prevent us from developing and commercializing any of our product candidates or a future product candidate, which could harm our
business, financial condition and operating results.
We expect that there are other companies, including major pharmaceutical companies, working in the areas competitive to our proposed product
candidates which either has resulted, or may result, in the filing of patent applications that may be deemed related to our activities. If we were to challenge the
validity of these or any issued U.S. patent in court, we would need to overcome a statutory presumption of validity that attaches to every issued U.S. patent.
This means that, in order to prevail, we would have to present clear and convincing evidence as to the invalidity of the patent’s claims. If we were to
challenge the validity of these or any issued U.S. patent in an administrative trial before the Patent Trial and Appeal Board in the U.S. PTO, we would have to
prove that the claims are unpatentable by a preponderance of the evidence. There is no assurance that a jury and/or court would find in our favor on questions
of infringement, validity or enforceability.
Others may claim an ownership interest in our intellectual property, which could expose us to litigation and have an adverse effect on our prospects.
A third party may claim an ownership interest in one or more of our or our licensors’ patents or other proprietary or intellectual property rights. A
third party could bring legal actions against us and seek monetary damages and/or enjoin clinical testing, manufacturing and marketing of the affected product
or products. We cannot guarantee that a third party will not assert a claim or an interest in any of such patents or intellectual property. If we become involved
in any litigation, it could consume a substantial portion of our resources, and cause a significant diversion of effort by our technical and management
personnel. If any of these actions are successful, in addition to any potential liability for damages, we could be required to obtain a license to continue to
manufacture or market the affected product, in which case we may be required to pay substantial royalties or grant cross-licenses to our patents. We cannot,
however, assure you that any such license will be available on acceptable terms, if at all. Ultimately, we could be prevented from commercializing a product
candidate, or be forced to cease some aspect of our business operations as a result of claims of patent infringement or violation of other intellectual property
rights. Further, the outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance, including the
demeanor and credibility of witnesses and the identity of any adverse party. This is especially true in intellectual property cases that may turn on the
testimony of experts as to technical facts upon which experts may reasonably disagree.
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We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed
alleged confidential information or trade secrets of their former employers.
As is commonplace in our industry, we will employ individuals who were previously employed at other pharmaceutical companies, including our
competitors or potential competitors. Although no claims against us are currently pending, we may be subject in the future to claims that our employees or
prospective employees are subject to a continuing obligation to their former employers (such as non-competition or non-solicitation obligations) or claims
that our employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation
may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be
a distraction to management.
Risks Related to Owning Our Common Stock
An active, liquid and orderly trading market for our shares may not continue to be developed or sustained.
Our common stock is listed on the Nasdaq Global Market. However, trading volume has been limited and a more active public market for our
common stock may not develop or be sustained over time. The market price of our common stock could be subject to significant fluctuations. The price of our
stock may change in response to variations in our operating results and also may change in response to other factors, including factors specific to companies
in our industry many of which are beyond our control. Our shares may be less liquid than the shares of other public companies and there may be imbalances
between supply and demand for our shares. As a result, our share price may experience significant volatility and may not necessarily reflect the value of our
expected performance. Moreover, sales of our common stock in the public market, or the perception that such sales could occur, could negatively impact the
price of our common stock. As a result, you may not be able to sell your shares of our common stock in short time periods, or possibly at all, and the price per
share of our common stock may fluctuate significantly.
Future capital raises may dilute our existing stockholders’ ownership, could depress the market price for our common stock and have other adverse
effects on our operations.
We filed a Form S-3 registration statement (“Shelf Registration”) with the SEC that became effective in December 2019 which will allow us to sell
any combination of common stock, preferred stock, debt securities, warrants to purchase any of these securities, subscription rights to purchase any of these
securities, and/or units consisting of one or more of the foregoing in one or more offerings up to a total dollar amount of $100 million. The issuance of
additional shares of our common stock pursuant to the Shelf Registration, or issuances of securities convertible into or exercisable for our common stock or
other equity-linked securities, including preferred stock, warrants, debt securities or units, would dilute the ownership interest of our common shareholders
and could depress the market price of our common stock and impair our ability to raise capital through the sale of additional equity securities. If we raise
additional funds by issuing debt securities, these debt securities would have rights senior to those of our common stock and the terms of the debt securities
issued could impose significant restrictions on our operations, including liens on our assets. If we raise additional funds through collaborations and licensing
arrangements, we may be required to relinquish some rights to our technologies or candidate products, or to grant licenses on terms that are not favorable to
us.
The trading price of the shares of our common stock may continue to be volatile, and purchasers of our common stock could incur substantial losses.
The trading price of our common stock has fluctuated significantly in the past and is likely to be volatile. The stock market in general, and early
stage public companies in particular, has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the
operating performance of such companies. The stock market in general has been, and the market price of our shares in particular will likely be, subject to
fluctuation, whether due to, or irrespective of, our operating results and financial condition. The market price of our shares on the Nasdaq Global Market may
fluctuate as a result of a number of factors, some of which are beyond our control, including, but not limited to:
● actual or anticipated variations in our and our competitors’ results of operations and financial condition;
● market acceptance of our products;
● the mix of products that we sell and related services that we provide;
● changes in earnings estimates or recommendations by securities analysts, if our shares are covered by analysts;
39
● development of technological innovations or new competitive products by others;
● announcements of technological innovations or new products by us;
● publication of the results of preclinical or clinical trials for our other product candidates;
● failure by us to achieve a publicly announced milestone;
● delays between our expenditures to develop and market new or enhanced products and the generation of sales from those products;
● developments concerning intellectual property rights, including our involvement in litigation brought by or against us;
● regulatory developments and the decisions of regulatory authorities as to the approval or rejection of new or modified products;
● changes in the structure of healthcare payment systems;
● changes in the amounts that we spend to develop, acquire or license new products, technologies or businesses;
● changes in our expenditures to promote our products;
● our sale or proposed sale, or the sale by our significant stockholders, of our shares or other securities in the future;
● changes in key personnel;
● success or failure of our research and development projects or those of our competitors;
● the trading volume of our shares; and
● general economic and market conditions and other factors, including factors unrelated to our operating performance.
These factors and any corresponding price fluctuations may materially and adversely affect the market price of our shares and result in substantial
losses being incurred by our investors. In the past, following periods of market volatility, public company stockholders have often instituted securities class
action litigation. If we were involved in securities litigation, it could impose a substantial cost upon us and divert the resources and attention of our
management from our business.
40
We are an “emerging growth company” under the JOBS Act of 2012 and we cannot be certain if the reduced disclosure requirements applicable to
emerging growth companies will make our common stock less attractive to investors.
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”), and we may take advantage of
certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including,
but not limited to:
● not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley
Act”);
● reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements;
● exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden
parachute payments; and
● extended transition periods available for complying with new or revised accounting standards.
We have chosen to “opt out” of the extended transition periods available for complying with new or revised accounting standards, but we intend to
take advantage of all of the other benefits available under the JOBS Act, including the exemptions discussed above. We cannot predict if investors will find
our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be
a less active trading market for our common stock and our stock price may be more volatile.
We will remain an “emerging growth company” for up to five years from the end of the fiscal year following the fifth anniversary of the date of the
first sale of our common stock pursuant to an effective registration statement filed under the Securities Act, which will be December 31, 2023. We will lose
that status sooner, however, if our revenues exceed $1.07 billion, if we issue more than $1 billion in non-convertible debt in a three-year period or if the
market value of our common stock that is held by non-affiliates exceeds $700 million as of any June 30.
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or
prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading
price of our common shares.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure
controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their
implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404 of the
Sarbanes-Oxley Act, or the subsequent testing by our independent registered public accounting firm when required, may reveal deficiencies in our internal
controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retrospective changes to our consolidated
financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our
reported financial information, which could have a negative effect on the trading price of our common shares. There is also a risk that neither we nor our
independent registered public accounting firm (when applicable in the future) will be able to conclude within the prescribed timeframe that internal controls
over financial reporting is effective as required by Section 404. This could result in an adverse reaction in the financial markets due to a loss of confidence in
the reliability of our financial statements.
Our status as an “emerging growth company” under the JOBS Act may make it more difficult to raise capital as and when we need it.
Because of the exemptions from various reporting requirements provided to us as an “emerging growth company,” we may be less attractive to
investors and it may be difficult for us to raise additional capital as and when we need it. Investors may be unable to compare our business with other
companies in our industry if they believe that our reporting is not as transparent as other companies in our industry. If we are unable to raise additional capital
as and when we need it, our financial condition and results of operations may be materially and adversely affected.
41
We have not paid dividends in the past and have no immediate plans to pay dividends, so any returns will be limited to the value of our stock.
We plan to reinvest all of our earnings, to the extent we have earnings, to cover operating costs and otherwise become and remain competitive. We
do not plan to pay any cash dividends with respect to our securities in the foreseeable future. We cannot assure you that we would, at any time, generate
sufficient surplus cash that would be available for distribution to the holders of our common stock as a dividend. Therefore, you should not expect to receive
cash dividends on our common stock, and any return to stockholders will therefore be limited to the appreciation of their stock.
If equity research analysts do not publish research or reports about our business or if they issue unfavorable commentary or downgrade our shares, the
price of our shares could decline.
The trading market for our shares will rely in part on the research and reports that equity research analysts publish about us and our business, if at all.
We do not have control over these analysts, and we do not have commitments from them to write research reports about us. The price of our shares could
decline if no research reports are published about us or our business, or if one or more equity research analysts downgrades our shares or if those analysts
issue other unfavorable commentary or cease publishing reports about us or our business.
We will continue to incur significant costs as a result of becoming a public company that reports to the Securities and Exchange Commission (the “SEC”)
and our management will be required to devote substantial time to meet compliance obligations.
As a newly public company reporting to the SEC, we incur significant legal, accounting and other expenses that we did not incur as a private
company. We are subject to reporting requirements of the Securities Exchange Act of 1934 (the “Exchange Act”), and the reporting and governance
provisions of the Sarbanes-Oxley Act and the Dodd-Frank Wall Street Reform and Protection Act, as well as rules subsequently implemented by the SEC, that
impose significant requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and
changes in corporate governance practices. There are significant corporate governance and reporting provisions in these laws that will increase our legal and
financial compliance costs, make some activities more difficult, time-consuming or costly and may also place undue strain on our personnel, systems and
resources. Our management and other personnel will need to devote a substantial amount of time to these regulations. In addition, we expect these rules and
regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced
policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and
retain qualified people to serve on our board of directors, our board committees or as executive officers.
Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
Our federal net operating losses (NOLs) generated in taxable years ending prior to 2018 could expire unused. Under the Tax Act, federal NOLs
incurred in taxable years ending after December 31, 2017, may be carried forward indefinitely, but the deductibility of federal NOLs generated in tax years
beginning before December 31, 2017, is limited. It is uncertain if and to what extent various states will conform to the Tax Act. In addition, under Sections
382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership
change,” which is generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period, the corporation’s ability to use
its pre-change NOL carryforwards, or NOLs, and other pre-change tax attributes (such as research tax credits) to offset its post-change income may be
limited. We are currently performing a study to determine if we have triggered any “ownership change” limitations. We may also experience ownership
changes in the future as a result of subsequent shifts in our stock ownership some of which may be outside of our control. As a result, if we earn net taxable
income, our ability to use our pre-ownership change NOL carryforwards to offset U.S. federal taxable income may be subject to limitations, which could
potentially result in increased future tax liability to us. In addition, at the state level, there may be periods during which the use of NOLs is suspended or
otherwise limited, which could accelerate or permanently increase state taxes owed.
Assuming a market for our common stock continues to develop, sales of a substantial number of shares of our common stock in the public market by our
existing stockholders could cause our stock price to fall.
Sales of a substantial number of shares of our common stock by our existing stockholders in the public market or the perception that these sales
might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities.
We are unable to predict the effect that such sales may have on the prevailing market price of our common stock.
As of February 28, 2020, we had 17,882,486 shares of common stock outstanding, all of which, other than shares held by our directors and certain
officers, are eligible for sale in the public market, subject in some cases to compliance with the requirements of Rule 144, including volume limitations and
manner of sale requirements.
42
Certain holders of our securities are entitled to rights with respect to the registration of their shares under the Securities Act of 1933, as amended (the
“Securities Act”). Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the
Securities Act. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.
We may be at an increased risk of securities class action litigation.
Historically, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This
risk is especially relevant for us because biotechnology and pharmaceutical companies have experienced significant stock price volatility in recent years. If
we were to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.
We have broad discretion over the use of proceeds from our IPO, a recent debt financing and potential future securities offerings.
Our management has considerable discretion in the application of the net proceeds from our IPO and debt financing in November 2019. We expect to
use the proceeds from our IPO and the debt financing to fund clinical trials, product licensing opportunities and product development; to fund FDA filing
fees; to fund laboratory expansion and for other general corporate purposes, including general and administrative expenses and working capital. However, our
needs may change as our business and industry evolve and, as a result, the proceeds from our IPO and the debt financing may be used in a manner
substantially different from our current expectations. We may use the net proceeds for purposes that do not yield a significant return or any return at all for our
stockholders. In addition, pending their use, we may invest the net proceeds from our IPO and debt financing in a manner that does not produce income or
that loses value. The failure by our management to apply these funds effectively could result in financial losses that could harm our business, cause the price
of our common stock to decline and delay the development of our product candidates.
In addition, our management will have broad discretion to use the net proceeds from any offerings under the Shelf Registration, and you will be
relying on the judgment of our management regarding the application of these proceeds. Except as described in any future prospectus supplement, the net
proceeds received by us from our sale of these securities will be added to our general funds and will be used for our general corporate purposes. Our
management might not apply the net proceeds from the offering of our securities in ways that increase the value of your investment and might not be able to
yield a significant return, if any, on any investment of such net proceeds. You may not have the opportunity to influence our decisions on how to use such
proceeds.
Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable.
Provisions in our amended and restated certificate of incorporation and amended and restated bylaws and applicable provisions of Delaware law may
delay or discourage transactions involving an actual or potential change in control or change in our management, including transactions in which stockholders
might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests. The provisions in
our amended and restated certificate of incorporation and amended and restated bylaws:
●
●
authorize our board of directors to issue, without further action by the stockholders, shares of undesignated preferred stock with terms, rights
and preferences determined by our board of directors that may be senior to our common stock;
establish an advance notice procedure for stockholder proposals to be brought before an annual meeting, including proposed nominations of
persons for election to our board of directors;
● establish that our board of directors is divided into three classes, with each class serving three-year staggered terms;
●
require the approval of our board of directors or the holders of at least seventy-five percent (75%) of our outstanding shares of capital stock to
amend our bylaws and certain provisions of our certificate of incorporation;
● limit who may call stockholder meetings;
● do not provide for cumulative voting rights; and
● provide that all vacancies may be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum.
43
In addition, Section 203 of the Delaware General Corporation Law may limit our ability to engage in any business combination with a person who
beneficially owns 15% or more of our outstanding voting stock unless certain conditions are satisfied. This restriction lasts for a period of three years
following the share acquisition. These provisions may have the effect of entrenching our management team and may deprive our stockholders of the
opportunity to sell their shares to potential acquirers at a premium over prevailing prices. This potential inability to obtain a control premium could reduce the
price of our common stock.
Our amended and restated certificate of incorporation designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for
certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes
with us or our directors, officers or stockholders .
Provisions in our amended and restated certificate of incorporation provide that the Court of Chancery of the State of Delaware will, to the fullest
extent permitted by law, be the sole and exclusive forum for:
● any derivative action or proceeding brought on our behalf;
● any action asserting a claim of breach of a fiduciary duty owed to us or our stockholders by any of our directors, officers or other employees;
● any action asserting a claim against us or any of our directors, officers or other employees arising pursuant to any provision of Delaware law or
our charter documents; or
● any action asserting a claim against us or any of our directors, officers or other employees governed by the internal affairs doctrine, but
excluding actions to enforce a duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive
jurisdiction.
In addition, unless we consent in writing to the selection of an alternative forum, the Federal district courts of the United States shall be the exclusive
forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. However, a court may determine that this provision is
unenforceable.
As stockholders in our company, you will be deemed to have notice of and have consented to the provisions of our amended and restated certificate
of incorporation related to choice of forum, but will not be deemed to have waived our compliance with the federal securities laws and the rules and
regulations thereunder. The choice of forum provisions in our amended and restated certificate of incorporation may limit our stockholders’ ability to obtain a
favorable judicial forum for disputes with us or any of our directors, officers or other employees, which may discourage lawsuits with respect to such claims.
Alternatively, if a court were to find the choice of forum provision contained in our restated charter to be inapplicable or unenforceable in an action, we may
incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations and financial
condition.
44
Ownership portions held by our executives and directors, as well as by our former parent company, Harrow Health, Inc., may limit our stockholders’
ability to influence corporate matters.
Our directors and executive officers beneficially own approximately 11.4% of our common stock. Additionally, Harrow Health, Inc. (“Harrow”), our
former parent company, holds approximately 19.6% of our outstanding common stock. Accordingly, these parties, together, can significantly influence,
though not independently determine, the outcome of matters required to be submitted to our stockholders 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. These interests may not be consistent with those
of our other stockholders. In addition, the significant interest held by these parties, and particularly by Harrow, may discourage third parties from seeking to
acquire control of us, which may adversely affect the market price of our shares.
We may be constrained by our obligations under our Credit Agreement to operate our business to its full potential.
On November 13, 2019, we entered into a $10 million credit facility with SWK Holdings Corporation (the “Credit Agreement”). The Credit
Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions
on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness and dividends and other distributions. Under the terms of the
Credit Agreement, we are required to comply with (a) a maximum senior secured net leverage ratio, (b) a maximum total net leverage ratio and a minimum
fixed charge coverage ratio. These terms may restrict our ability to operate our business in the manner we deem most effective or desirable, and may restrict
our ability to fund our operations through new public offerings of our common stock or strengthen our candidate development pipeline through acquisitions
or licenses which cause us to exceed our maximum senior secured net leverage ratio.
Failure to comply with the representations and warranties or affirmative and negative covenants could constitute an event of default which, if
continued beyond the cure period, would allow the Agent (as defined in the Credit Agreement), at the request of or with the consent of the lenders holding a
majority of the loans and commitments under the facility, to terminate the commitments of the lenders to make further loans and declare all the obligations of
the loan parties under the Credit Agreement to be immediately due and payable, either of which could harm our business.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
We conduct all of our administrative activities for Eton Pharmaceuticals, Inc. at our 5,507 square foot leased office space located at 21925 W. Field
Parkway, Suite 235, Deer Park, Illinois 60010. The lease for this facility expires on March 31, 2021.
We operate a 2,782 square foot research and development operation at a leased space located at 85 Oakwood Road, Lake Zurich, Illinois 60047. The
lease for this facility expires on February 28, 2021 and may be extended for an additional two-year period.
We consider our current facilities suitable and adequate to meet our current needs.
Item 3. Legal Proceedings
None.
Item 4. Mine Safety Disclosures
Not applicable.
45
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market Information
PART II
Our common stock is listed on the Nasdaq Global Market under the symbol “ETON.” The closing price of our common stock on the Nasdaq Global
Market on December 31, 2019, the last trading date in 2019, was $7.20 per share.
Record Holders
As of February 28, 2020, we had 16 holders of record of our common stock. The actual number of stockholders is greater than this number of record
holders and includes stockholders who are beneficial owners but whose shares are held in street name by brokers and other nominees. This number of holders
of record also does not include stockholders whose shares may be held in trust by other entities. The closing price per share of our common stock on February
28, 2020 was $5.40
Dividends
We have never declared or paid a cash dividend on our common stock. We currently intend to retain any future earnings and do not expect to pay any
dividends in the foreseeable future. Any future determinations to pay cash dividends will be made at the discretion of our board of directors, subject to
applicable laws, and will depend on a number of factors, including our financial condition, results of operations, capital requirements, contractual restrictions,
general business conditions, and any other factors that our board of directors may deem relevant.
Recent Sales of Unregistered Securities
In November 2018, we entered into an underwriting agreement, relating to the public offering of 4,140,000 shares of common stock at a price to the
public of $6.00 per share, less underwriting discounts and commissions. In November 2018, in connection with the underwriting agreement, we issued
warrants exercisable for 414,000 shares of common stock at an exercise price of $7.50 per share to National Securities Corporation, a wholly owned
subsidiary of National Holdings, Inc.
The issuance of these warrants was made in reliance on the exemption from registration contained in Section 4(a)(2) of the Securities Act of 1933, as
amended (the “Securities Act”) and/or Regulation D promulgated thereunder as private transactions not involving a public offering of securities.
In November 2019, in connection with the Credit Agreement, we issued a warrant exercisable for shares of common stock equal to six percent (6%)
of the principal amount of draws upon exercise of each tranche under the Credit Agreement divided by the average trading price of common stock for the ten
trading days immediately preceding such exercise.
The issuance of this warrant was made in reliance on the exemption from registration contained in Section 4(a)(2) of the Securities Act and/or
Regulation as private transactions not involving a public offering of securities.
Item 6. Selected Financial Data
Not applicable.
46
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis together with our financial statements and the related notes thereto included in “Item 8.
Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. The following discussion contains forward-looking statements that
involve risks and uncertainties. For a complete discussion of forward-looking statements, see the section above entitled “Forward Looking Statements.” Our
actual results could differ materially from those expressed or implied in any forward-looking statements as a result of various factors, including those set
forth under the caption “Item 1A. Risk Factors.”
Overview
We were formed in April 2017 as a specialty pharmaceutical company focused on developing and commercializing innovative pharmaceutical
products utilizing the FDA’s 505(b)(2) regulatory pathway. Our business model is to develop proprietary innovative products that fulfill an unmet patient
need. Since our formation, we have focused our efforts on the development of our initial product candidates, engaging in preliminary discussions with the
FDA concerning the regulatory pathway for certain additional product candidates, registration filings of our initial product candidates and the licensing of
late-stage product candidates.
In December 2019 we launched our Biorphen product and we have established a diversified pipeline of other product candidates in various stages of
development, four of which have been submitted to the FDA and are under review. We intend to focus on product candidates that are liquid in formulation,
including injectables, oral liquids and ophthalmics, and qualify under the FDA’s 505(b)(2) regulatory pathway.
Our corporate strategy is to pursue what we perceive to be low-risk product candidates where existing published literature, historical clinical trials, or
physician usage has established safety and/or efficacy of the molecule, thereby reducing the incremental clinical burden required for us to bring the product to
patients. We intend to pursue product candidates that require a single small Phase 3 trial, a bioequivalence trial, or literature-based filings. Prior to initiating
significant development activities on a product candidate, we typically meet with the FDA to establish a defined clinical and regulatory path to approval.
We believe our product candidates can address situations where patient needs are not being met by current FDA-approved pharmaceutical products.
This may include products that are being supplied on an unapproved basis, products that are currently being compounded, and products that are approved and
widely used internationally but not approved in the United States.
Results of Operations
To date we have realized only limited revenues from a licensing arrangement on our EM-100 product and the launch of our Biorphen product. We
anticipate successfully completing development of additional product candidates in 2020 and beyond and growing our business.
Year Ended December 31, 2019 Compared to Year Ended December 31, 2018
For the years ended December 31, 2019 and 2018, we generated $1.0 and $0 in revenue, respectively. The revenue realized in 2019 was from a
licensing arrangement for our EM-100 product which is pending additional FDA review and the launch of our Biorphen product in December 2019. For the
years 2019 and 2018, we incurred $11.6 million and $5.6 million of research and development (“R&D”) expenses, respectively, and $7.6 million and $4.7
million of general and administrative (“G&A”) expenses, respectively. The comparative period detail of our R&D expense is listed in the table below. The
$2.9 million increase in G&A expenses was primarily due to additional expenses related to becoming a public company, sales and marketing for the launch of
our Biorphen product, and the impact of personnel additions in the second half of 2018 and first half of 2019. This was partially offset by lower stock-based
consulting expenses. In addition, the change in the fair value of our warrant liability reflected in other expense decreased by $2.6 million as this mark–to–
market accounting treatment was terminated in conjunction with our November 2018 IPO. We incurred a net loss of $18.3 million and $12.7 million for the
years ended December 31, 2019 and 2018, respectively.
General and Administrative Expenses
G&A expenses consist primarily of employee compensation expenses, stock-based consulting service fees, sales and marketing expenses, business
insurance, legal and professional fees and travel expenses.
47
Research and Development Expenses
Set forth below is our R&D spending for our current product candidates. We currently have ten employees that support our overall product
development and we also have facility and operating costs for a laboratory that supports our product development. The laboratory personnel and related
capital equipment additions were added in late 2018. We do not track internal costs by product for our employees and laboratory expenses and they are listed
as indirect expenses in the table below (amounts are in thousands).
Product Candidate
DS-200
DS-300
EM-100
ET-105
ET-202
Other products
Indirect expenses
Total
Year ended
December 31, 2019
Year ended
December 31, 2018
$
$
1,901 $
1,237
150
2,127
2,000
1,374
2,766
11,555 $
910
1,251
1,265
—
—
1,026
1,175
5,627
Year Ended December 31, 2018 Compared to Period Ended December 31, 2017
For the periods ended December 31, 2018 and 2017, we incurred $5.6 million and $3.9 million of research and development (“R&D”) expenses,
respectively, and $4.7 million and $3.2 million of general and administrative (“G&A”) expenses, respectively. The comparative period detail of our R&D
expense is listed in the table below. The $1.5 million increase in G&A expenses was primarily due to the partial year start-up in late April 2017 as compared
to a full year of operations in 2018 combined with personnel additions in the second half of 2018. Our compensation-related costs increased by $1.1 million
plus costs for our board of directors increased by $0.4 million. In addition, the fair value of our warrant liability reflected in other expense increased by $2.5
million as a result of the increase in our stock price up to the date of our IPO. We incurred a net loss of $12.7 million and $7.2 million for the periods ended
December 31, 2018 and 2017, respectively.
General and Administrative Expenses
G&A expenses consist primarily of employee compensation expenses, stock-based consulting service fees, legal and professional fees and travel
expenses. We anticipate that our G&A expenses will significantly increase to support our business growth and the additional costs associated with being a
public company.
Research and Development Expenses
Set forth below is our R&D spending for our current product candidates. We currently have nine employees that support our overall product
development and we also have facility and operating costs for a laboratory that will support product development. We do not track internal costs by product
for our employees and laboratory expenses and they are listed as indirect expenses in the table below (amounts are in thousands).
Product Candidate
DS-200
DS-300
EM-100
Other products
Indirect expenses
Total
Year ended December
31, 2018
Period from
April 27,2017
(Inception) to December
31, 2017
$
$
910 $
1,251
1,265
1,026
1,175
5,627 $
1,686
402
470
975
397
3,930
48
Liquidity and Capital Resources
As of December 31, 2019, we had total assets of $17.1 million and working capital of $13.0 million. We had previously capitalized our operations
primarily from the June 2017 private placement of approximately $20.1 million of Series A preferred stock, par value $0.001 (the “Series A Preferred”). Our
Series A Preferred accumulated dividends at the rate of 6% per annum and those shares of stock plus all accrued but unpaid dividends automatically
converted into shares of our common stock concurrent with our IPO in November 2018 at the conversion price of 50% of the IPO price. The IPO provided us
with net proceeds of $22.0 million and we also entered into a Credit Agreement with SWK Holdings in November 2019 which provides for up to $10 million
in additional borrowing, $5.0 million of which was received at closing. We believe that our existing funding and the revenue from our Biorphen product and
potential milestones and royalty payments from EM-100 will be sufficient for at least the next twelve months of our operations. However, our projected
estimates for our product development spending, administrative expenses and our working capital requirements could be inaccurate, or we may experience
growth more quickly or on a larger scale than we expect, any of which could result in the depletion of capital resources more rapidly than anticipated and
could require us to seek additional financing earlier than we expect to support our operations.
Cash Flows
The following table sets forth a summary of our cash flows for the periods ended December 31, 2019, 2018 and 2017 (amounts are in thousands):
Net cash used in operating activities
Cash used in investing activities
Cash flows provided by financing activities
Net increase in cash and cash equivalents
Year ended
December 31, 2019
Year ended
December 31, 2018
$
$
(18,026)
(1,846)
5,203
(14,669)
$
$
(8,145) $
(236)
21,960
13,579 $
Period from
April 27, 2017
(Inception) to
December 31, 2017
(4,718)
(130)
18,004
13,156
The increase in cash used in operating activities is primarily a result of higher operating losses due to our business expansion including additional
personnel and increased product candidate development activity. Investing activities consist primarily of licensing fees for Biorphen and capital expenditures
for setting up our laboratory facility and our headquarters office. The financing activity primarily consists of the Series A Preferred private placement funding
in June 2017, the November 2018 IPO and the November 2019 Credit Agreement with SWK Holdings.
Critical Accounting Policies
Our financial statements are prepared in accordance with GAAP. The preparation of our financial statements and related disclosures requires us to
make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses in our condensed financial statements. We base our
estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of
which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our
estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 3 to our financial statements included herein, we believe that the
following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Revenue
We account for contracts with its customers in accordance with Accounting Standards Codification (“ASC”) 606 — Revenue from Contracts with
Customers. ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity
recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to
receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC
606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii)
determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the
entity satisfies a performance obligation.
49
At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each
contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. We then recognize as revenue
the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. We assess
whether these options provide a material right to the customer and, if so, they are considered performance obligations. The exercise of a material right is
accounted for as a contract modification for accounting purposes.
We recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each
performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method. Any amounts
received prior to revenue recognition will be recorded as deferred revenue. Amounts expected to be recognized as revenue within the twelve months
following the balance sheet date will be classified as current portion of deferred revenue in our balance sheets. Amounts not expected to be recognized as
revenue within the twelve months following the balance sheet date are classified as long-term deferred revenue, net of current portion.
Milestone Payments – If a commercial contract arrangement includes development and regulatory milestone payments, we will evaluate whether the
milestone conditions have been achieved and if it is probable that a significant revenue reversal would not occur before recognizing the associated revenue.
Milestone payments that are not within our control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being
achieved until those approvals are received.
Royalties – For arrangements that include sales-based royalties, including milestone payments based on a level of sales, which are the result of a
customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, we will recognize revenue at the
later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or
partially satisfied. To date, we have not recognized any royalty revenue resulting from any of our licensing arrangements.
Significant Financing Component – In determining the transaction price, we will adjust consideration for the effects of the time value of money if the
expected period between payment by the licensees and the transfer of the promised goods or services to the licensees will be more than one year.
We sell Biorphen in the U.S. to wholesale pharmaceutical distributors, who then sell the product to hospitals and other end-user customers. Sales to
wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual shipments of Biorphen represent
performance obligations under each purchase order. We use a third-party logistics (“3PL”) vendor to process and fulfill orders and have concluded it is the
principal in the sales to wholesalers because it controls access to the 3PL vendor services rendered and directs the 3PL vendor activities. We have no
significant obligations to wholesalers to generate pull-through sales.
Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when the wholesalers sell
Biorphen at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs. In addition, the we pay
fees to wholesalers for their distribution services, inventory reporting and chargeback processing. We pay GPOs fees for administrative services and for
access to GPO members and concluded the benefits received in exchange for these fees are not distinct from our sales of Biorphen, and accordingly we apply
these amounts to reduce revenues. Wholesalers also have rights to return unsold product nearing or past the expiration date. Because of the shelf life of
Biorphen and our lengthy return period, there may be a significant period of time between when the product is shipped and when we issue credits on returned
product.
We estimate the transaction price when we receive each purchase order, taking into account the expected reductions of the selling price initially
billed to the wholesaler arising from all of the above factors. We have developed estimates for future returns and chargebacks of Biorphen and the impact of
the other discounts and fees we pay. When estimating these adjustments to the transaction price, we reduce it sufficiently to be able to assert that it is probable
that there will be no significant reversal of revenue when the ultimate adjustment amounts are known.
We recognize revenue from Biorphen product sales and related cost of sales upon product delivery to the wholesaler location. At that time, the
wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable obligation to pay us. They also have the
ability to direct sales of product to their customers on terms and at prices they negotiate. Although wholesalers have product return rights, we do not believe
they have a significant incentive to return the product to us.
Upon recognition of revenue from product sales of Biorphen, the estimated amounts of credit for product returns, chargebacks, distribution fees,
prompt payment discounts, and GPO fees are included in sales reserves, accrued liabilities and net of accounts receivable. We monitor actual product returns,
chargebacks, discounts and fees subsequent to the sale. If these amounts end up differing from our estimates, we will make adjustments to these allowances,
which are applied to increase or reduce product sales revenue and earnings in the period of adjustment.
50
In addition, we anticipate we will receive revenues from product licensing agreements where we have contracted for milestone payments and
royalties from products we have developed or for which we have acquired the rights to a product developed by a third party.
Stock-Based Compensation
We account for stock-based compensation under the provisions of the Financial Accounting Standards Board (the “FASB”) Accounting Standards
Codification (“ASC”) – 718 Compensation – Stock Compensation. The guidance under ASC 718 requires companies to estimate the fair value of the stock-
based compensation awards on the date of grant for employees and directors and record expense over the related service periods, which are generally the
vesting period of the equity awards. Awards for consultants are accounted for under ASC 505-50 - Equity Based Payments to Non-Employees. Compensation
expense is recognized over the period during which services are rendered by such consultants and non-employees until completed. At the end of each
financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair value of our common
stock and updated assumption inputs in the Black-Scholes option-pricing model (“BSM”).
We estimate the fair value of stock-based option awards to our employees and directors using the BSM. The BSM requires the input of subjective
assumptions, including the expected stock price volatility, the calculation of expected term, forfeitures and the fair value of the underlying common stock on
the date of grant, among other inputs. The risk-free interest rate was determined from the implied yields for zero-coupon U.S. government issues with a
remaining term approximating the expected life of the options or warrants. Dividends on common stock are assumed to be zero for the BSM valuation of the
stock options. The expected term of stock options granted is based on vesting periods and the contractual life of the options. Expected volatilities are based on
comparable companies’ historical volatility, which management believes represents the most accurate basis for estimating expected future volatility under the
current conditions. We account for forfeitures as they occur.
Prior to our initial public offering in November 2018 (the “IPO”), the fair value of the shares of common stock underlying our stock-based awards
was determined by our board of directors, with input from management. Because there had been no public market for our common stock prior to the IPO, our
board of directors had determined the fair value of the common stock on the grant-date of the stock-based award by considering a number of objective and
subjective factors, including enterprise valuations of our common stock performed by an unrelated third-party specialist, valuations of comparable companies,
sales of our convertible preferred stock to unrelated third parties, operating and financial performance, the lack of liquidity of our capital stock, and general
and industry-specific economic outlook. Following our IPO, we use the closing stock price on the date of grant for the fair value of the common stock.
Research and Development Expenses
R&D expenses include both internal R&D activities and external contracted services. Internal R&D activity expenses include salaries, benefits and
stock-based compensation and other costs to support our R&D operations. External contracted services include product development efforts including certain
product licensor milestone payments, clinical trial activities, manufacturing and control-related activities and regulatory costs. R&D expenses are charged to
operations as incurred. We review and accrue R&D expenses based on services performed and rely upon estimates of those costs applicable to the stage of
completion of each project. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual
results could differ from our estimates.
Upfront payments and milestone payments made for the licensing of technology for products that are not yet approved by the FDA are expensed as
R&D in the period in which they are incurred. Nonrefundable advance payments for goods or services to be received in the future for use in R&D activities
are recorded as prepaid expenses and are expensed as the related goods are delivered or the services are performed.
51
Off Balance Sheet Transactions
We do not have any off-balance sheet transactions.
JOBS Act Transition Period
In April 2012, the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), was enacted. Section 107 of the JOBS Act provides that an
“emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with
new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would
otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new
or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.
We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject to
certain conditions, as an emerging growth company, we may rely on certain of these exemptions, including without limitation, (i) providing an auditor’s
attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any
requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the
auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an
emerging growth company until the earlier to occur of (1) the last day of the fiscal year (a) December 31, 2023, which is the end of the fiscal year following
the fifth anniversary of the completion of our IPO, (b) in which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to
be a “large accelerated filer” under the rules of the SEC, which means the market value of our common stock that is held by non-affiliates exceeds $700
million as of the prior June 30th, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
The primary objective of our investment activities is to preserve capital. We do not utilize hedging contracts or similar instruments. We are exposed
to certain market risks relating primarily to interest rate risk on our cash and cash equivalents and risks relating to the financial viability of the institutions
which hold our capital and through which we have invested our funds. We manage such risks by investing in short-term, liquid, highly-rated instruments. As
of December 31, 2019, our cash equivalents and investments are invested exclusively in money market funds. We do not believe we have any material
exposure to interest rate risk due to the extremely low interest rate environment and the short duration of the invested funds we hold. Declines in interest rates
would reduce our investment income but would not have a material effect on our financial condition or results of operations. We do not currently have
exposure to foreign currency risk.
52
Item 8. Financial Statements and Supplementary Data
ETON PHARMACEUTICALS, INC.
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm
Balance Sheets
Statements of Operations
Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Statements of Cash Flows
Notes to Financial Statements
53
54
55
56
57
58
59
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Eton Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Eton Pharmaceuticals, Inc. (the “Company”) as of December 31, 2019 and 2018, the related
statements of operations, redeemable convertible preferred stock and stockholders’ equity (deficit) and cash flows for the years ended December 31, 2019 and
2018, and the period from April 27, 2017 (inception) to December 31, 2017 and the related notes and the financial statement schedule listed in the index at
Item 15 (2) (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial
position of the Company as of December 31, 2019 and 2018, and the results of its operations and its cash flows for each of the years ended December 31,
2019 and 2018 and the period from April 27, 2017 (inception) to December 31, 2017, in conformity with accounting principles generally accepted in the
United States of America.
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/ KMJ Corbin & Company LLP
We have served as the Company’s auditor since 2018.
Costa Mesa, California
March 5, 2020
54
Eton Pharmaceuticals, Inc.
BALANCE SHEETS
(in thousands, except share and per share amounts)
December 31, 2019
December 31, 2018
Assets
Current assets:
Cash and cash equivalents
Accounts receivable, net
Inventory
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Intangible assets, net
Operating lease right-of-use assets, net
Other long-term assets, net
Total assets
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
Accrued liabilities
Total current liabilities
Long-term debt, net of discount and including accrued fees
Operating lease liabilities, net of current portion
Total liabilities
Commitments and contingencies (Note 16)
Stockholders’ equity
Common stock, $0.001 par value; 50,000,000 shares authorized as of December 31, 2019 and
2018; 17,877,486 and 17,607,928 shares issued and outstanding at December 31, 2019 and
2018, respectively
Additional paid-in capital
Accumulated deficit
Total stockholders’ equity
$
$
$
12,066 $
473
380
2,090
15,009
1,117
725
160
61
17,072 $
575 $
1,388
1,963
4,540
19
6,522
18
74,720
(64,188)
10,550
Total liabilities and stockholders’ equity
$
17,072 $
The accompanying notes are an integral part of these financial statements.
55
26,735
—
—
767
27,502
773
—
—
52
28,327
1,421
603
2,024
—
—
2,024
18
72,153
(45,868)
26,303
28,327
Eton Pharmaceuticals, Inc.
STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
For the years ended
December 31,
December 31,
Period from
April 27, 2017
(Inception) to
December 31,
2019
2018
2017
$
$
$
459
500
959
453
506
— $
—
—
—
—
11,555
7,552
19,107
5,627
4,694
10,321
—
—
—
—
—
3,930
3,220
7,150
(18,601)
(10,321)
(7,150)
281
—
164
(2,583)
35
(41)
Revenues:
Product sales
Licensing revenue
Total revenues
Cost of product sales
Gross profit
Operating expenses:
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income (expense):
Interest and other income, net
Change in fair value of warrant liability
Loss before income tax expense
(18,320)
(12,740)
(7,156)
Income tax expense
Net loss
—
—
—
(18,320)
(12,740)
(7,156)
Accrued dividends on redeemable convertible preferred stock
Deemed dividends for accretion of redeemable convertible preferred stock issuance
costs
Deemed dividends for beneficial conversion feature of redeemable convertible
preferred stock
—
—
—
(1,048)
(1,694)
(21,747)
Net loss attributable to common stockholders
Net loss per share attributable to common stockholders, basic and diluted
Weighted average number of common shares outstanding, basic and diluted
$
$
(18,320)
(1.03)
17,761
$
$
(37,229) $
(5.80) $
6,418
(643)
(840)
—
(8,639)
(2.50)
3,453
The accompanying notes are an integral part of these financial statements.
56
Eton Pharmaceuticals, Inc.
STATEMENTS OF REEDEMABLE CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS’ EQUITY (DEFICIT)
(in thousands, except share amounts)
Redeemable
Convertible
Preferred Stock
Common Stock
Paid-in Accumulated
Additional
Total
Stockholders’
Equity
Balances at April 27, 2017 (Inception)
Common Stock issued to founder
Stock-based compensation
Issuance of Series A redeemable convertible
preferred stock, net of issuance costs
Accrued dividends on redeemable convertible
preferred stock
Deemed dividends for accretion of redeemable
convertible preferred stock issuance costs
Net loss
Shares
Amount
—
— $
Shares
Amount Capital
— $
— $
— $
—
—
—
3,500,000
—
2,500,000
4
2
—
1,759
6,685,082
17,521
—
—
—
Deficit
(Deficit)
— $
—
—
—
—
4
1,761
—
—
643
—
—
—
(643)
(643)
—
—
840
—
—
—
—
—
—
—
(840)
(840)
(7,156)
(7,156)
Balances at December 31, 2017
6,685,082 $ 19,004
6,000,000 $
6 $
1,759 $
(8,639) $
(6,874)
Stock-based compensation
—
—
218,980
—
1,850
—
1,850
Accrued dividends on redeemable convertible
preferred stock
Deemed dividends for accretion of redeemable
convertible preferred stock issuance costs
Issuance of common stock in connection with
initial public offering, including underwriter’s
over-allotment, net of offering costs and
underwriter’s discount
Conversion of redeemable convertible
preferred stock (including accrued dividends)
to common stock in connection with initial
public offering
Reclassification of common stock warrants
from liability to additional paid-in-capital
Beneficial conversion feature on redeemable
convertible preferred stock
Net loss
—
1,048
—
—
—
(1,048)
(1,048)
—
1,694
—
—
—
(1,694)
(1,694)
—
—
4,140,000
4
21,956
—
21,960
(6,685,082)
(21,746)
7,248,948
8
21,738
—
21,746
—
—
—
—
3,103
—
3,103
—
—
—
—
—
—
—
21,747
(21,747)
—
—
—
(12,740)
(12,740)
Balances at December 31, 2018
— $
—
17,607,928 $
18 $
72,153 $
(45,868) $
26,303
Stock-based compensation
Stock option exercises
Common stock issued under employee stock
purchase plan
Stock warrant exercises
Relative fair value of warrants to purchase
common stock issued in connection with debt
Net loss
—
—
—
—
—
—
—
—
—
167,622
—
—
—
—
44,885
57,051
—
—
—
—
—
—
—
—
1,888
214
239
—
226
—
—
—
—
—
1,888
214
239
—
226
—
(18,320)
(18,320)
Balances at December 31, 2019
— $
—
17,877,486 $
18 $
74,720 $
(64,188) $
10,550
The accompanying notes are an integral part of these financial statements.
57
Eton Pharmaceuticals, Inc.
STATEMENTS OF CASH FLOWS
(In thousands)
For the years ended
December 31,
December 31,
Period from
April 27, 2017
(Inception) to
December 31,
2019
2018
2017
$
(18,320)
$
(12,740) $
(7,156)
Cash flows from operating activities
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation
Depreciation and amortization
Debt discount amortization
Change in fair value of warrant liability
Changes in operating assets and liabilities:
Accounts receivable
Inventory
Prepaid expenses and other assets
Accounts payable
Accrued liabilities
Net cash used in operating activities
Cash used in investing activities
Purchases of property and equipment
Purchase of product licensing rights
Net cash used in investing activities
Cash flows from financing activities
Proceeds from issuance of long-term debt, net of issuance costs
Proceeds from initial public offering, net of underwriting discounts and
commissions
Payments of initial public offering costs
Proceeds from issuance of redeemable convertible preferred stock, net of issuance
costs
Proceeds from issuance of common stock
Proceeds from employee stock purchase plan and stock option exercises
Net Cash provided by financing activities
Change in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
Supplemental disclosures of cash flow information
Cash paid for interest
Cash paid for income taxes
Supplemental disclosures of non-cash investing and financing activities:
Accrued dividends on redeemable convertible preferred stock
Deemed dividends for accretion of redeemable convertible preferred stock issuance
costs
Common stock warrant liability issued with redeemable convertible preferred stock
financing
Relative fair value of common stock warrants issued in connection with debt
Purchase of equipment included in accounts payable
Beneficial conversion feature on redeemable convertible preferred stock
Reclassification of common stock warrants from liability to additional paid-in-
capital
$
$
$
$
$
$
$
$
$
$
1,888
447
16
—
(473)
(380)
(1,361)
(377)
534
(18,026)
(1,096)
(750)
(1,846)
4,750
—
—
—
—
453
5,203
(14,669)
26,735
12,066
—
—
—
—
—
226
—
—
—
$
$
$
$
$
$
$
$
$
$
1,850
63
—
2,583
—
—
(663)
413
349
(8,145)
(236)
—
(236)
—
22,803
(843)
—
—
—
21,960
13,579
13,156
26,735 $
— $
— $
1,048 $
1,694 $
— $
— $
469 $
21,747 $
3,103 $
1,761
13
—
41
—
—
(170)
539
254
(4,718)
(130)
—
(130)
—
—
—
18,000
4
—
18,004
13,156
—
13,156
—
—
643
840
479
—
—
—
—
The accompanying notes are an integral part of these financial statements.
58
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 1 — Company Overview
Eton Pharmaceuticals, Inc. (“Eton” or the “Company”) was incorporated as a Delaware “C” corporation on April 27, 2017 and was initially set up as
a wholly-owned subsidiary of Harrow Health, Inc. (“Harrow”, fka Imprimis Pharmaceuticals, Inc.).
Eton raised $20,055 in start-up capital through the sale of its Series A redeemable convertible preferred stock (“Series A Preferred”) in June 2017
and a separate management team was then established for Eton with its corporate offices located in Deer Park, Illinois. Eton is a specialty pharmaceutical
company focused on developing and commercializing prescription drug products utilizing the U.S. Food and Drug Administration’s (the “FDA”) 505(b)(2)
regulatory pathway. The Company’s business model is to develop proprietary innovative product candidates that offer commercial and/or functional
advantages to currently available alternatives.
In November 2018, the Company completed an initial public offering (“IPO”), selling 4,140,000 shares of common stock at an offering price of
$6.00 per share, including the underwriter’s exercise in full of its option to purchase additional shares. The Company received net proceeds of $21,960, after
deducting underwriting discounts and commissions and offering-related expenses (see Note 8).
The Company’s Biorphen® product was approved by the FDA in October 2019 and sales commenced for this product at the end of 2019.
Note 2 — Liquidity Considerations
As of December 31, 2019, the Company had an accumulated deficit of $64,188 and for the year ended December 31, 2019 the Company used net
cash in operating activities of $18,026.
To date, the Company has realized limited revenues from two products, but expects further growth in 2020 and beyond and currently believes its
existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next twelve months
from the date of issuance of these financial statements. This estimate is based on the Company’s current assumptions, including assumptions relating to
estimated sales and its ability to manage its spending. The Company could use its available capital resources sooner than currently expected. Accordingly, the
Company could seek to obtain additional capital through equity financings, the issuance of debt or other arrangements. However, there can be no assurance
that the Company will be able to raise additional capital if needed or under acceptable terms, if at all. The sale of additional equity may dilute existing
stockholders and newly issued shares may contain senior rights and preferences compared to currently outstanding common shares. The Company’s existing
long-term debt obligation contains covenants and limits the Company’s ability to pay dividends or make other distributions to stockholders. If the Company
experiences delays in product sales growth and completing its product development and obtaining regulatory approval for its other product candidates and is
unable to obtain such additional financing, operations would need to be scaled back or discontinued.
Note 3 — Summary of Significant Accounting Policies
Basis of Presentation
The Company has prepared the accompanying financial statements in accordance with accounting principles generally accepted in the United States
of America (“GAAP”).
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue
and expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, the
useful lives of long-lived assets, the accrual of research and development expenses and the valuation of common stock, stock options, warrants and derivative
instruments. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in
which they become known. Actual results could differ from those estimates or assumptions.
59
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 3 — Summary of Significant Accounting Policies (continued)
Segment Information
The Company operates the business on the basis of a single reportable segment, which is the business of developing and commercializing
prescription drug products. The Company’s chief operating decision-maker is the Chief Executive Officer (“CEO”), who evaluates the Company as a single
operating segment.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash
equivalents are held in U.S. financial institutions. Cash equivalents consist of an interest-bearing checking account. From time to time, amounts deposited
exceed federally insured limits. The Company believes the associated credit risk to be minimal.
Accounts Receivable
Accounts receivable is recorded at the invoiced amount and is non-interest bearing. Accounts receivable is recorded net of allowances for doubtful
accounts, cash discounts for prompt payment, distribution fees, chargebacks and returns and allowances.
Inventory
The Company values its inventory at the lower of cost or net realizable value using the first-in, first-out method of valuation. The Company reviews
its inventory for potential excess or obsolete issues and will record a write-down if an impairment is identified. Inventory at December 31, 2019 consists
solely of purchased finished goods.
Property and Equipment
Property and equipment are stated at cost. Depreciation of property and equipment is computed utilizing the straight-line method based on the
following estimated useful lives. Computer hardware and software is depreciated over three years. Equipment, furniture and fixtures is depreciated over five
years. Leasehold improvements are amortized over their estimated useful lives or the remaining lease term, whichever is shorter. Construction in progress is
capitalized but not depreciated until it is placed into service.
Maintenance and repairs are charged to expense as incurred, while renewals and improvements are capitalized.
Intangible Assets
The Company capitalizes payments it makes for licensed products when the payment is based on FDA approval for the product and the cost is
recoverable based on expected future cash flows from the product. The cost is amortized on a straight-line basis over the estimated useful life of the product
commencing on the approval date in accordance with ASC 350-30. To date, a $750 payment related to the approval of its Biorphen product has been
capitalized and that cost is being amortized over five years.
Impairment of Long-Lived Assets
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be
recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future
cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is
recognized in the Company’s statements of operations for the amount by which the carrying amount of the asset exceeds the fair value of the asset. No
impairment was recognized during the periods ended December 31, 2019, 2018 and 2017.
60
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 3 — Summary of Significant Accounting Policies (continued)
Debt Issuance Costs and Debt Discount and Detachable Debt-Related Warrants
Costs incurred to issue debt are deferred and recorded as a reduction to the debt balance in the accompanying balance sheets. The Company
amortizes debt issuance costs over the expected term of the related debt using the effective interest method. Debt discounts relate to the relative fair value of
warrants issued in conjunction with the debt and are also recorded as a reduction to the debt balance and accreted over the expected term of the debt to
interest expense using the effective interest method.
Classification and Accretion of Redeemable Convertible Preferred Stock
Prior to the Company’s IPO in November 2018, the Company classified the Series A Preferred outside of stockholders’ equity (deficit) because the
shares contained certain redemption features that were not solely within the control of the Company. The carrying value of the Series A Preferred was
accreted to its redemption value from the date of issuance through November 15, 2018, the date of the Company’s IPO. In conjunction with the IPO, the
Series A Preferred, including accrued and unpaid dividends, automatically converted to shares of the Company’s common stock (see Note 7).
Beneficial Conversion Feature
Prior to the IPO in November 2018, the Company classified its Series A Preferred as temporary equity due to a possible cash redemption feature in
the event that an IPO or alternate financing was not completed by December 31, 2018. At the IPO date, the Series A Preferred, and related accrued and unpaid
dividends, automatically converted into shares of the Company’s common stock. The conversion share calculation was based on the $3.00 initial issuance
price for the Series A Preferred plus any accrued but unpaid dividends and converted to common stock using a stated divisor conversion price equal to 50% of
the IPO price to the public, which was $6.00 per share. In accordance with relevant accounting literature, since the stated terms of the conversion option did
not permit the Company to compute the additional number of shares that it would need to issue upon conversion of the Series A Preferred when the
contingent event occurred, the Company recorded the beneficial conversion amount of $21,747 as a deemed dividend at the date of the IPO in November
2018.
Leases
The Company adopted ASC Topic 842- “Leases”, effective January 1, 2019, using the modified retrospective method. The reported results for fiscal
year 2019 reflect the application of ASC Topic 842, while the reported results for prior fiscal years are not adjusted and continue to be reported under the
prior ASC Topic 840 guidance for leases. Refer to Impact of New Accounting Pronouncements regarding the adoption impact of ASC Topic 842 in the year
ended December 31, 2019.
The Company reviews all relevant facts and circumstances of a contract to determine if it is a lease whereby the terms of the agreement convey the
right to control the direct use and receive substantially all of the economic benefits of an identified asset for a period of time in exchange for consideration.
The associated right-of-use assets and lease liabilities are recognized at lease commencement. The Company measures lease liabilities based on the present
value of the lease payments over the lease term discounted using the rate it would pay on a loan with the equivalent payments and term for the lease. The
Company does not include the impact for lease term options that would extend or terminate the lease unless it is reasonably certain that it will exercise any
such options. The Company accounts for the lease components separately from non-lease components for its operating leases.
The Company measures right-of-use assets based on the corresponding lease liabilities adjusted for (i) any prepayments made to the lessor at or
before the commencement date, (ii) initial direct costs it incurs, and (iii) any incentives under the lease. In addition, the Company evaluates the recoverability
of its right-of-use assets for possible impairment in accordance with its long-lived assets policy.
Operating leases are reflected on the balance sheets as operating lease right-of-use assets, current accrued liabilities and long-term operating lease
liabilities. The Company does not have any finance leases as of December 31, 2019 and 2018.
The Company commences recognizing operating lease expense when the lessor makes the underlying asset available for use by the Company and the
operating lease expense is recognized on a straight-line basis. Variable lease payments are expensed as incurred.
The Company does not recognize right-of-use assets or lease liabilities for leases with a term of twelve months or less; such lease costs are recorded
in the statements of operations on a straight-line basis over the lease term.
61
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 3 — Summary of Significant Accounting Policies (continued)
Patent Costs
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about
the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses.
Concentrations of Credit Risk, Sources of Supply and Significant Customers
The Company is subject to credit risk for its cash and cash equivalents invested in money market funds. The Company maintains its cash and cash
equivalent balances with one major commercial bank and the deposits held with the financial institution exceed the amount of insurance provided on such
deposits and is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents to the extent recorded on the
balance sheets.
The Company is dependent on third-party vendors for its product candidates. In particular, the Company relies, and expects to continue to rely, on a
small number of vendors to manufacture key chemicals and process its product candidates for its development programs. These programs could be adversely
affected by a significant interruption in the manufacturing process.
The Company is also subject to credit risk from its accounts receivable related to product sales as it extends credit based on an evaluation of the
customer’s financial condition, and collateral is not required. Management monitors its exposure to accounts receivable by periodically evaluating the
collectability of the account receivable based on a variety of factors including the length of time the receivables are past due, the financial health of the
customer and historical experience. Based upon the review of these factors, the Company recorded no allowance for doubtful accounts at December 31, 2019.
The accounts receivable balance at December 31, 2019 and product sales revenue recognized during the year ended December 31, 2019 consist of sales to and
amounts due from AmerisourceBergen Corporation, Cardinal Health Services and McKesson Corporation for sales of its Biorphen product.
Revenue Recognition for Contracts with Customers
The Company accounts for contracts with its customers in accordance with Accounting Standards Codification (“ASC”) 606 — Revenue from
Contracts with Customers. ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606,
an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity
expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope
of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract;
(iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as)
the entity satisfies a performance obligation.
At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised
within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company
then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance
obligation is satisfied. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered
options. The Company assesses whether these options provide a material right to the customer and, if so, they are considered performance obligations. The
exercise of a material right is accounted for as a contract modification for accounting purposes.
The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each
performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method. Any amounts
received prior to revenue recognition will be recorded as deferred revenue. Amounts expected to be recognized as revenue within the twelve months
following the balance sheet date will be classified as current portion of deferred revenue in the Company’s balance sheets. Amounts not expected to be
recognized as revenue within the twelve months following the balance sheet date are classified as long-term deferred revenue, net of current portion.
Milestone Payments – If a commercial contract arrangement includes development and regulatory milestone payments, the Company will evaluate
whether the milestone conditions have been achieved and if it is probable that a significant revenue reversal would not occur before recognizing the
associated revenue. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not
considered probable of being achieved until those approvals are received.
62
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 3 — Summary of Significant Accounting Policies (continued)
Royalties – For arrangements that include sales-based royalties, including milestone payments based on a level of sales, which are the result of a
customer-vendor relationship and for which the license is deemed to be the predominant item to which the royalties relate, the Company will recognize
revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been
satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements.
Significant Financing Component – In determining the transaction price, the Company will adjust consideration for the effects of the time value of
money if the expected period between payment by the licensees and the transfer of the promised goods or services to the licensees will be more than one year.
The Company sells Biorphen in the U.S. to wholesale pharmaceutical distributors, who then sell the product to hospitals and other end-user
customers. Sales to wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual shipments of
Biorphen represent performance obligations under each purchase order. The Company uses a third-party logistics (“3PL”) vendor to process and fulfill orders
and has concluded it is the principal in the sales to wholesalers because it controls access to the 3PL vendor services rendered and directs the 3PL vendor
activities. The Company has no significant obligations to wholesalers to generate pull-through sales.
Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when the wholesalers sell
Biorphen at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs. In addition, the
Company pays fees to wholesalers for their distribution services, inventory reporting and chargeback processing. The Company pays GPOs fees for
administrative services and for access to GPO members and concluded the benefits received in exchange for these fees are not distinct from its sales of
Biorphen, and accordingly it applies these amounts to reduce revenues. Wholesalers also have rights to return unsold product nearing or past the expiration
date. Because of the shelf life of Biorphen and the Company’s lengthy return period, there may be a significant period of time between when the product is
shipped and when it issues credits on returned product.
The Company estimates the transaction price when it receives each purchase order taking into account the expected reductions of the selling price
initially billed to the wholesaler arising from all of the above factors. The Company has developed estimates for future returns and chargebacks of Biorphen
and the impact of the other discounts and fees it pays. When estimating these adjustments to the transaction price, the Company reduces it sufficiently to be
able to assert that it is probable that there will be no significant reversal of revenue when the ultimate adjustment amounts are known.
The Company recognizes revenue from Biorphen product sales and related cost of sales upon product delivery to the wholesaler location. At that
time, the wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable obligation to pay the Company.
They also have the ability to direct sales of product to their customers on terms and at prices they negotiate. Although wholesalers have product return rights,
the Company does not believe they have a significant incentive to return the product.
Upon recognition of revenue from product sales of Biorphen, the estimated amounts of credit for product returns, chargebacks, distribution fees,
prompt payment discounts, and GPO fees are included in sales reserves, accrued liabilities and net of accounts receivable. The Company monitors actual
product returns, chargebacks, discounts and fees subsequent to the sale. If these amounts end up differing from its estimates, it will make adjustments to these
allowances, which are applied to increase or reduce product sales revenue and earnings in the period of adjustment.
In addition, the Company anticipates it will receive revenues from product licensing agreements where it has contracted for milestone payments and
royalties from products it has developed or for which it has acquired the rights to a product developed by a third party.
Cost of Product Sales
Cost of product sales consists of the profit-sharing fees with the Company’s product licensing and development partners, the purchase costs for
finished products from third-party manufacturers and freight and handling/storage costs from the Company’s 3PL logistics service provider. The cost of sales
for profit-sharing fees and costs for purchased finished products and the associated inbound freight expense is recorded when the associated product sale
revenue is recognized in accordance with the terms of shipment to customers while outbound freight and handling/storage fees charged by the 3PL service
provider are expensed as they are incurred.
63
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 3 — Summary of Significant Accounting Policies (continued)
Research and Development Expenses
Research and development (“R&D”) expenses include both internal R&D activities and external contracted services. Internal R&D activity expenses
include salaries, benefits and stock-based compensation and other costs to support the Company’s R&D operations. External contracted services include
product development efforts such as certain product licensor milestone payments, clinical trial activities, manufacturing and control-related activities and
regulatory costs. R&D expenses are charged to operations as incurred. The Company reviews and accrues R&D expenses based on services performed and
relies upon estimates of those costs applicable to the stage of completion of each project. Significant judgments and estimates are made in determining the
accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates.
Upfront payments and milestone payments made for the licensing of technology for products that are not yet approved by the FDA are expensed as
R&D in the period in which they are incurred. Nonrefundable advance payments for goods or services to be received in the future for use in R&D activities
are recorded as prepaid expenses and are expensed as the related goods are delivered or the services are performed.
Earnings (Loss) Per Share
Basic net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted average
number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders
for the period by the weighted average number of common and common equivalent shares, such as Series A Preferred, unvested restricted stock, stock
options and warrants that are outstanding during the period. Common stock equivalents are excluded from the computation when their inclusion would be
anti-dilutive. No such adjustments were made for 2019, 2018 or 2017 as the Company reported a net loss for the periods ended December 31, 2019, 2018 and
2017 and including the effects of common stock equivalents in the diluted earnings per share calculation would have been antidilutive (See Note 11).
Warrant Liability
The Company estimated the fair value of certain warrants at each reporting period using Level 3 inputs. The estimates in valuation models were
based, in part, on subjective assumptions, including but not limited to stock price volatility, the expected life of the warrants, the risk-free interest rate and the
exercise price of the warrants, and could differ materially in the future. Changes in the fair value of the warrant liability during the period were recorded as a
component of other income (expense) at the end of each reporting period for changes in fair value until the Company’s IPO in November 2018, which
established a fixed number of shares for these warrants. At the date of the IPO, the warrant liability amount was reclassified as a component of additional
paid-in-capital.
Stock-Based Compensation
The Company accounts for stock-based compensation under the provisions of the Financial Accounting Standards Board (the “FASB”) Accounting
Standards Codification (“ASC”) — 718 Compensation — Stock Compensation. The guidance under ASC 718 requires companies to estimate the fair value of
the stock-based compensation awards on the date of grant for employees and directors and record expense over the related service periods, which are
generally the vesting period of the equity awards. Awards for consultants are accounted for under ASC 505-50 — Equity Based Payments to Non-Employees.
Compensation expense is recognized over the period during which services are rendered by such consultants and non-employees until completed. At the end
of each financial reporting period prior to completion of the service, the fair value of these awards is remeasured using the then-current fair value of the
Company’s common stock and updated assumption inputs in the Black-Scholes-Merton option-pricing model (“BSM”).
The Company estimates the fair value of stock-based option awards to its employees and directors using the BSM. The BSM requires the input of
subjective assumptions, including the expected stock price volatility, the calculation of expected term and the fair value of the underlying common stock on
the date of grant, among other inputs. The risk-free interest rate was determined from the implied yields for zero-coupon U.S. government issues with a
remaining term approximating the expected life of the options or warrants. Dividends on common stock are assumed to be zero for the BSM valuation of the
stock options. The expected term of stock options granted is based on vesting periods and the contractual life of the options. Expected volatilities are based on
comparable companies’ historical volatility, which management believes represents the most accurate basis for estimating expected future volatility under the
current conditions. The Company accounts for forfeitures as they occur.
64
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 3 — Summary of Significant Accounting Policies (continued)
Prior to the Company’s IPO, the fair value of the shares of the Company’s common stock underlying its stock-based awards was determined by its
board of directors, with input from management. Because there had been no public market for the Company’s common stock prior to the IPO, the board of
directors had determined the fair value of the common stock on the grant-date of the stock-based award by considering a number of objective and subjective
factors, including enterprise valuations of its common stock performed by an unrelated third-party specialist, valuations of comparable companies, sales of its
convertible preferred stock to unrelated third parties, operating and financial performance, the lack of liquidity of the capital stock, and general and industry-
specific economic outlook. Following the IPO in November 2018, the Company uses the closing stock price on the date of grant for the fair value of the
common stock.
Income Taxes
As part of the process of preparing the Company’s financial statements, the Company must estimate the actual current tax liabilities and assess
temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and
liabilities, which are included within the balance sheets. The Company must assess the likelihood that the deferred tax assets will be recovered from future
taxable income and, to the extent the Company believes that recovery is not likely, a valuation allowance must be established. To the extent the Company
establishes a valuation allowance or increase or decrease to this allowance in a period, the impact will be included in income tax expense in the statements of
operations. As of December 31, 2019 and 2018, the Company has established a 100% valuation reserve against its deferred tax assets.
The Company accounts for income taxes under the provisions of FASB ASC 740 - Income Taxes. As of December 31, 2019 and 2018, there were no
unrecognized tax benefits included in the balance sheets that would, if recognized, affect the effective tax rate. The Company’s practice is to recognize
interest and penalties related to income tax matters in income tax expense. The Company had no accrual for interest or penalties in its balance sheets at
December 31, 2019 or 2018, and has not recognized interest and penalties in the statements of operations for the periods ended December 31, 2019, 2018 and
2017. As of December 31, 2019, the Company is subject to taxation in the United States and Illinois. The Company’s tax losses from 2019, 2018 and 2017 are
subject to examination by the federal and state tax authorities due to the carryforward of unutilized net operating losses (“NOLs”).
The Tax Cuts and Jobs Act of 2017 (the “Tax Act”) significantly revised U.S. corporate income tax law by, among other things, reducing the
corporate income tax rate to 21% and implementing a modified territorial tax system. In response to the Tax Act, the SEC issued Staff Accounting Bulletin
(“SAB”) 118 which allows issuers to recognize provisional estimates of the impact of the Tax Act in their financial statements and adjust in the period in
which the estimates become finalized, or in circumstances where estimates cannot be made, to disclose and recognize within a one-year measurement period.
Implementation of the Tax Act resulted in a $733 charge for the revaluation of the Company’s net deferred tax assets offset by a corresponding $733
reduction in the valuation reserve for income taxes during the period ended December 31, 2017.
Current accounting standards include guidance on the accounting for uncertainty in income taxes recognized in the financial statements. Such
standards also prescribe a recognition threshold and measurement model for the financial statement recognition of a tax position taken, or expected to be
taken, and provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company
believes that the ultimate deductibility of all tax positions is highly certain, although there is uncertainty about the timing of such deductibility. As a result, no
liability for uncertain tax positions was recorded as of December 31, 2019 or 2018.
Fair Value Measurements
We measure certain of our assets and liabilities at fair value. Fair value represents 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. Fair value accounting requires characterization of the inputs used to
measure fair value into a three-level fair value hierarchy as follows:
Level 1 — Inputs based on quoted prices in active markets for identical assets or liabilities. An active market is a market in which transactions occur
with sufficient frequency and volume to provide pricing information on an ongoing basis.
Level 2 — Observable inputs that reflect the assumptions market participants would use in pricing the asset or liability developed based on market
data obtained from sources independent from the entity.
65
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 3 — Summary of Significant Accounting Policies (continued)
Level 3 — Unobservable inputs that reflect the entity’s own assumptions about the assumptions market participants would use in pricing the asset or
liability developed based on the best information available.
Fair value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment of the
significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets and liabilities and their
placement within the fair value hierarchy levels. The determination of the fair values stated below takes into account the market for the Company’s financials,
assets and liabilities, the associated credit risk and other factors as required. The Company considers active markets as those in which transactions for the
assets or liabilities occur in sufficient frequency and volume to provide pricing information on an ongoing basis.
The Company’s financial instruments included cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities and long-term
debt obligation. The carrying amounts of these financial instruments, except for the long-term debt obligation, approximate fair value due to the short-term
maturities of these instruments. Based on borrowing rates currently available to the Company, the carrying value of the long-term debt obligation
approximates its fair value.
The fair values of the Company’s warrant liability at inception and for subsequent mark-to-market fair value measurements were based on
management’s valuation model and expectations with respect to the method and timing of settlement. The Company determined that the warrant liability fair
values were classified as Level 3 measurements within the fair value hierarchy. At the date of the Company’s IPO in November 2018, the fair value was
reclassified to additional paid-in-capital as the final number of shares for the warrants previously reflected as a liability became fixed (see Notes 4 and 9).
Impact of New Accounting Pronouncements
In February 2016, the FASB issued ASU 2016-02 (Topic 842) – Leases (“ASC 842”), which requires the lease rights and obligations arising from
lease contracts, including existing and new arrangements for substantially all leases with terms more than twelve months to be recognized as assets and
liabilities on the balance sheet. Recognition, measurement and presentation of expenses depends upon classification as a finance or operating lease. The
Company adopted ASC 842 effective January 1, 2019 utilizing the modified retrospective approach such that prior year financial statements were not recast
under the new standard. The adoption of ASU 2016-02 did not have a material effect on the Company’s financial condition from the recognition of the lease
rights and obligations as assets and liabilities or its results of operations and cash flows. See Note 13 for additional information regarding the new standard
and its impact on the Company’s financial statements.
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial
Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit
losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities,
entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted
to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. The Company plans
to adopt the new guidance on January 1, 2020 and does not anticipate the adoption will have a material impact on its financial position or results of
operations.
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820). The new guidance removes, modifies and adds to certain
disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement. The Company plans to adopt the new guidance on January 1,
2020 and does not anticipate the adoption will have a material impact on its financial position or results of operations.
In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes. The new guidance removes certain exceptions to
the general principles of ASC 740 in order to simplify the complexities of its application. These changes include eliminations to the exceptions for intraperiod
tax allocation, recognizing deferred tax liabilities related to outside basis differences, and year-to-date losses in interim periods among others. The Company
will adopt ASU 2019-12 in January 2020 and does not anticipate it will have a material impact on its financial position or results of operations.
66
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 4 — Fair Value of Financial Assets and Liabilities
Valuation of Warrant Liability
The Company previously accounted for a warrant to purchase shares of its common stock that was issued to the Company’s placement agent in
connection with the Series A Preferred offering (see Note 9) as a liability. The fair value of the warrant liability was determined based on significant inputs
not observable in the market, which represented a Level 3 measurement within the fair value hierarchy. The Company used the BSM, which incorporates
assumptions and estimates, to value the warrant. Estimates and assumptions impacting the fair value measurement included the fair value per share of the
underlying shares of common stock, the remaining contractual term of the warrant, risk-free interest rate, expected dividend yield and expected volatility of
the price of the underlying common stock. The Company determined the fair value per share of the underlying common stock by taking into consideration the
most recent sales of its preferred stock, results obtained from third-party valuations and additional factors that were deemed relevant. The Company
historically had been a private company and lacked company-specific historical and implied volatility information of its common stock. Therefore, the
Company estimated its expected stock volatility based on the historical volatility of publicly traded peer companies for a term equal to the remaining
contractual term of the warrant. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve for time periods approximately equal
to the remaining contractual term of the warrant. The Company estimated a 0% expected dividend yield based on the fact that the Company had never paid or
declared dividends and did not intend to do so in the foreseeable future.
In November 2018, in connection with the Company’s IPO, the number of shares issuable upon the exercise of the warrant became fixed (see Note
9). The Company remeasured the estimated fair value on the date of the IPO and reclassified this amount to additional paid-in-capital.
The following table provides a roll forward of the aggregate fair values of the Company’s warrant liability, for which fair value was determined
using Level 3 inputs:
Balance as of the beginning of the period
Initial fair value of warrant liability
Change in fair value
Warrant liability reclassified to additional paid-in-capital
Balance as of the end of the period
Note 5 – Property and Equipment
Property and equipment consist of the following:
Computer hardware and software
Furniture and fixtures
Equipment
Leasehold improvements
Construction in progress
Less: accumulated depreciation and amortization
Property and equipment, net
Year ended
December 31,
2018
Period from
April 27, 2017
(inception) to
December 31,
2017
520 $
—
2,583
(3,103)
— $
—
479
41
—
520
December 31, 2019
December 31, 2018
174 $
133
994
152
9
1,462
(345)
1,117 $
93
98
99
53
492
835
(62)
773
$
$
$
$
Depreciation and amortization expense for the periods ended December 31, 2019, 2018 and 2017 was $283, $51 and $11, respectively.
67
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 6 – Long-term Debt
On November 13, 2019, the Company entered into a credit agreement (the “SWK Credit Agreement”) with SWK Holdings Corporation (“SWK”)
which provides for up to $10,000 in financing. The Company received proceeds of $5,000 at closing and may borrow an additional $5,000 upon the FDA
approval of a second product developed by the Company, excluding EM-100. Alternatively, the Company can borrow $2,000 upon FDA approval of the EM-
100 product candidate and then an additional $3,000 upon FDA approval of another one of its product candidates. The term of the SWK Credit Agreement is
five years and borrowings bear interest at a rate of LIBOR 3-month plus 10.0%, subject to a stated LIBOR floor rate of 2.0%. In connection with the SWK
Credit Agreement, the Company paid $250 in cash for issuance costs and issued warrants to SWK to purchase common stock of the Company in an amount
equal to 6.0% of the principal amounts drawn under the SWK Credit Agreement, utilizing the prior ten-day average closing price of the Company’s common
stock as a divisor to calculate the number shares issuable under the warrant. A 2.0% unused credit limit fee is assessed during the first twelve months after the
date of the SWK Credit Agreement and loan fees include a 5.0% exit fee based on the principal amounts drawn which is payable at the end of the term of the
SWK Credit Agreement. The Company is required to maintain a minimum cash balance of $3,000, will only pay interest on the debt until May 2021 and then
will pay 4.0% of the loan principal balance commencing on May 15, 2021 and then every three months thereafter until November 13, 2024 at which time the
remaining principal balance is due. Borrowings under the SWK Credit Agreement are secured by the Company’s assets. The SWK Credit Agreement contains
customary default provisions and covenants which include limits on additional indebtedness. SWK and the Company will negotiate covenant targets for
EBITDA and revenue within 180 days of the date of the SWK Credit Agreement.
In connection with the SWK Credit Agreement, the Company issued warrants to SWK to purchase 51,239 shares of the Company’s common stock
(the “SWK Warrants”) with an exercise price of $5.86 per share. The SWK Warrants are exercisable immediately and have a term of seven years. The SWK
Warrants are subject to a cashless exercise feature, with the exercise price and number of shares issuable upon exercise subject to change in connection with
stock splits, dividends, reclassifications and other conditions. The relative fair value of the SWK Warrants was $226 and was estimated using the Black-
Scholes-Merton option pricing model with the following assumptions: fair value of the Company’s common stock at issuance of $5.75 per share; seven-year
contractual term; 95% volatility; 0% dividend rate; and a risk-free interest rate of 1.8%.
The debt discount amortization recorded in 2019 was $16 and $82 was recorded for accrued interest and included in accrued liabilities.
The table below reflects the future payments for the SWK loan principal and interest as of December 31, 2019.
2020
2021
2022
2023
2024
Total payments
Less: amount representing interest
Loan payable, gross
Less: unamortized discount
Long-term debt, net of unamortized discount
68
$
$
Amount
717
1,165
1,173
996
3,805
7,856
(2,856)
5,000
(460)
4,540
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 7 — Redeemable Convertible Preferred Stock — Series A
The Company has 10,000,000 authorized shares of $0.001 par value preferred stock as per its Amended and Restated Certificate of Incorporation. In
June 2017, the Company issued 6,685,082 Series A Preferred at a price of $3.00 per share and all shares remained outstanding until the Company’s IPO in
November 2018. The gross proceeds were $20,055 from the Series A Preferred stock offering. The Series A Preferred shares, including accrued and unpaid
dividends, automatically converted to the Company’s common shares at the date of the IPO (See Note 8).
As of the date of the IPO on November 15, 2018, the liquidation value of the Series A Preferred was $21,746, which consisted of the issuance
amount of $20,055 plus accrued dividends of $1,691.
The Series A Preferred automatically converted to common shares upon completion of the IPO in November 2018. The conversion share calculation
was based on the $3.00 initial issue price for the Series A Preferred plus accrued and unpaid dividends, and automatically converted into shares of the
Company’s common stock using a stated divisor conversion price equal to 50% of the IPO price to the public which was $6.00 per share. In accordance with
relevant accounting literature, since the terms of the conversion option did not permit the Company to compute the additional number of shares that it would
need to issue upon conversion of the Series A Preferred when the contingent event occurred, the Company recorded the beneficial conversion amount of
$21,747 as a deemed dividend at the date of the IPO in November 2018.
As a result of the Series A Preferred having a possible cash redemption feature in the event that an IPO or alternate financing was not completed by
December 31, 2018, the Series A Preferred was classified as temporary equity and not included as part of Company’s stockholders’ equity (deficit) prior to
the November 2018 IPO. In accordance with that classification, the $2,534 of issuance costs associated with the Series A Preferred offering were being
ratably accreted as a deemed dividend using the effective interest method through the expected redemption date.
Note 8 — Common Stock
The Company has 50,000,000 authorized shares of $0.001 par value common stock as per its Amended and Restated Certificate of Incorporation. In
May 2017, the Company issued 3,500,000 shares of its common stock to Harrow, 1,500,000 shares of restricted stock to certain executives and staff of
Harrow and 1,000,000 shares of restricted stock to the CEO of the Company. On January 1, 2018, the Company issued 54,745 restricted shares of its common
stock to each of its four outside directors (218,980 total shares) as part of their compensation for board service to the Company in 2018. The restricted shares
issued to the Harrow executives and staff vested over a 12-month period, the restricted shares issued to the CEO vest over a 24-month period and the
restricted shares issued to the outside directors vested 25% at each quarter-end in 2018 and were fully vested as of December 31, 2018. The Company
accounted for the restricted stock awards (“RSAs”) in accordance with ASC 718 or ASC 505-50. For the periods ended December 31, 2019, 2018 and 2017,
the Company recorded $59, $1,388 and $1,403, respectively, in stock-based compensation expense for these RSAs (see Note 10).
In conjunction with the Company’s IPO in November 2018, the Series A Preferred shares, including accrued dividends, converted into 7,248,948
shares of the Company’s common stock, and the Company issued 4,140,000 additional shares of its common stock to investors in its IPO (See Notes 1 and 7).
During 2019, there were 97,088 warrant shares exercised (all on a cashless basis) resulting in 57,051 shares of common stock being issued by the
Company. In addition, 167,622 stock option shares were exercised and issued under the Company’s 2018 Equity Incentive Plan and 44,885 shares were issued
under the Company’s Employee Stock Purchase Program.
69
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 9 — Common Stock Warrants
In May 2017, the Company issued a warrant to purchase 600,000 shares of its common stock to consultants for business strategy and intellectual
property advisory services. The warrant vested at issuance in May 2017 and has a $0.01 exercise price per warrant share and expires five years from the date
of issuance. The Company used the BSM to value the warrant and the fair value at the date of issuance was $121 based on an expected term of five years,
volatility of 85%, a risk-free interest rate of 1.8% and a 0% rate on expected dividends. The $121 amount for the consulting warrants was expensed as a
component of the Company’s general and administrative expenses in May 2017.
In conjunction with the closing of the Series A Preferred offering in June 2017 (see Note 7), the Company issued a warrant to purchase 649,409
shares of its common stock to the placement agent at an exercise price of $3.00 per share, provided, however, upon the conversion of the Series A Preferred,
the warrant adjusted to entitle the holder to purchase shares of common stock equal to 10.0% of the shares of common stock issuable upon conversion of the
Series A Preferred (excluding 191,000 shares of Series A Preferred that were purchased by insiders) and the exercise price would adjust to the conversion
price of the Series A Preferred. This warrant vested at issuance in June 2017. The Company used the BSM to value the warrant and the fair value at the date
of issuance was $479. Prior to the Company’s IPO in November 2018, the number of common shares issuable upon the exercise of this warrant was not fixed
as it could vary by a factor of 1.000 to 1.333 common shares per warrant share in accordance with the IPO price, and the Company considered the warrant to
be a derivative instrument. The $479 amount was recorded as a component of the issuance costs for the Series A Preferred in June 2017. As of December 31,
2017, the fair value of the warrant was $520 and the $41 increase in fair value during 2017 was recorded as a component of other income and expense.
In connection with the SWK Credit Agreement, the Company issued warrants to SWK to purchase 51,239 shares of the Company’s common stock
(the “SWK Warrants”) with an exercise price of $5.86 per share. The SWK Warrants are exercisable immediately and have a term of seven years ending
November 13, 2026. The SWK Warrants are subject to a cashless exercise feature, with the exercise price and number of shares issuable upon exercise subject
to change in connection with stock splits, dividends, reclassifications and other conditions. The relative fair value of the SWK Warrants was $226 and was
estimated using the Black-Scholes-Merton option pricing model with the following assumptions: fair value of the Company’s common stock at issuance of
$5.75 per share; seven-year contractual term; 95% volatility; 0% dividend rate; and a risk-free interest rate of 1.8%. The $226 relative fair value for these
warrants was reflected as a component of paid-in-capital in the Company’s balance sheet.
As of November 15, 2018, the fair value of the warrants was $3,103 and the $2,583 increase in fair value during 2018 was recorded as a component
of other income and expense. The fair value assumptions included an expected term of five years, expected volatility of 85%, a risk-free interest rate of 2.9%
and estimate of the conversion rate. These warrants were classified as warrant liability on the Company’s balance sheets prior to the IPO in November 2018.
In connection with the Company’s IPO, the number of shares issuable upon the exercise of these warrants became fixed at 704,184 shares which eliminated
the fair value adjustment after that date. At the IPO date, the warrant liability was reclassified to additional paid-in-capital.
During November 2018, in connection with the IPO, the Company issued warrants for 414,000 shares of its common stock to the placement agent at
an exercise price of $7.50 per share.
The weighted average exercise price of the outstanding warrants for the consultant, placement agent and debt holder as of December 31, 2019 and
2018 was $3.13 and $3.04 per share, respectively.
70
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 9 — Common Stock Warrants (continued)
Listed below is a summary of warrants outstanding as of December 31, 2019:
Description of Warrants
Business Advisory Warrants
Placement Agent Warrants - Series A Preferred
Placement Agent Warrants - IPO
SWK Warrants - Debt
Total
No. of Shares
Exercise Price
600,000
704,184
414,000
51,239
1,672,335
$
$
$
$
$
0.01
3.00
7.50
5.86
3.13 (Avg)
The holders of these warrants or their permitted transferees, are entitled to rights with respect to the registration under the Securities Act of their
shares that are converted to common stock, including demand registration rights and piggyback registration rights. These rights are provided under the terms
of a registration rights agreement between the Company and the investors.
A rollforward of the warrants outstanding is listed in the table below:
Balance as of the beginning of the year
Issuance of SWK Warrants with long-term debt
Placement Agent Warrants exercised – Series A Preferred
Balance as of the end of the year
No. of Shares
1,718,184
51,239
(97,088)
1,672,335
During 2019, 97,088 warrants were exercised (all on a cashless basis) resulting in 57,051 shares of common stock being issued by the Company. The
intrinsic value of the warrants exercised was $401.
Note 10 — Share-Based Payment Awards
The Company’s board of directors and stockholders approved the Eton Pharmaceuticals, Inc. 2017 Equity Incentive Plan in May 2017 (the “2017
Plan”), which authorized the issuance of up to 5,000,000 shares of the Company’s common stock. In conjunction with the Company’s IPO in November 2018,
the Company’s stockholders and board of directors approved the 2018 Equity Incentive Plan (the “2018 Plan”) which succeeded the 2017 Plan. The Company
has granted RSAs, stock options and restricted stock units (“RSUs”) for its common stock under the 2017 Plan and 2018 Plan as detailed in the tables below.
There were 887,837 shares available for future issuance under the 2018 Plan as of December 31, 2018.
Shares that are expired, terminated, surrendered or canceled without having been fully exercised will be available for future awards under the 2018
Plan. In addition, the 2018 Plan provides that commencing January 1, 2019 and through January 1, 2028, the share reserve will be increased by 4% of the
total number of shares outstanding as of the preceding December 31, subject to a reduction at the discretion of the Company’s board of directors. On January
1, 2019, the share reserve was increased by 704,317 shares based on the 17,607,928 shares of common stock outstanding at December 31, 2018. The exercise
price for stock options granted is not less than the fair value of common stock as determined by the board of directors as of the date of grant. Prior to the IPO,
the Company’s board of directors valued the Company’s common stock, taking into consideration its most recently available valuation of common stock
performed by third parties as well as additional factors which might have changed since the date of the most recent contemporaneous valuation through the
date of grant. Following the IPO, the Company has used the closing stock price on the date of grant as the exercise price.
71
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 10 — Share-Based Payment Awards (continued)
On January 1, 2018, the Company issued 54,745 restricted shares of its common stock to each of its four outside directors (218,980 total shares). The
restricted shares issued to the outside directors vested 25% at each quarter-end in 2018 and became fully vested at December 31, 2018.
To date, all stock options issued have been non-qualified stock options and the exercise prices were set at the fair value for the shares at the dates of
grant. Options generally have a ten-year life, except for options to purchase 50,000 shares of the Company’s common stock granted to product consultants
that expire within five years if the Company is not able to successfully file certain product submissions to the FDA prior to the five-year expiration date.
Furthermore, these option awards to the Company’s product consultants do not vest unless certain product submissions are made to the FDA, and accordingly,
the Company has not recorded any expense for these contingently vesting option awards to its product consultants.
For the periods ended December 31, 2019, 2018 and 2017, the Company’s total stock-based compensation expense was $1,888, $1,850 and $1,761,
respectively. Of these amounts, $1,574, $1,770 and $1,735 was recorded in general and administrative expenses, respectively, and $314, $80 and $26 was
recorded in R&D expenses, respectively.
A summary of stock option activity is as follows:
Options outstanding as of January 1, 2019
Issued
Exercised
Forfeited/Cancelled
Options outstanding as of December 31, 2019
Options exercisable at December 31, 2019
Options vested and expected to vest at December 31, 2019
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
Aggregate
Intrinsic
Value
1.78
7.44
1.28
6.20
4.01
3.09
4.08
8.3 $
5,627
8.1 $
7.5 $
8.1 $
6,014
3,038
5,723
Shares
1,295,000
717,500
(167,622)
(15,000)
1,829,878
730,193
1,779,878
$
$
$
$
The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the
Company’s common stock for those stock options that had strike prices lower than the fair value of the Company’s common stock at December 31. The
intrinsic value of the options exercised was $932.
There were 167,622 shares issued for exercises of stock options during the year ended December 31, 2019 for proceeds of $214.
The assumptions used to calculate the fair value of options granted during the periods ended December 31, 2019, 2018 and 2017 under the BSM
were as follows:
Expected dividends
Expected volatility
Risk-free interest rate
Expected term
Weighted average fair value
December 31, 2019
December 31, 2018
December 31, 2017
—%
90%
1.9-2.5%
5.9 years
5.54
$
—%
85%
2.8-2.9%
6.3 years
3.39
$
—%
85%
1.7-2.3%
5.8-10 years
0.91
$
72
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 10 — Share-Based Payment Awards (continued)
Expected Term — The Company has opted to use the “simplified method” for estimating the expected term of options granted to employees and
directors, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option (generally 10 years).
The expected term of options granted to non-employees equals the contractual life of the options.
Expected Volatility — Due to the Company’s limited operating history and a lack of Company-specific historical and implied volatility data, the
Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical
volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of
the stock-based awards.
Risk-Free Interest Rate — The risk-free rate assumption is based on the U.S. Treasury instruments with maturities similar to the expected term of the
Company’s stock options.
Expected Dividend — The Company has not issued any dividends in its history and does not expect to issue dividends over the life of the options
and therefore has estimated the dividend yield to be zero.
Fair value of Common Stock — Prior to the Company’s IPO in November 2018, the fair value of the shares of common stock underlying the stock-
based awards was determined by the board of directors, with input from management. Because there was no public market for the Company’s common stock,
the board of directors determined the fair value of the common stock on the grant-date of the stock-based award by considering a number of objective and
subjective factors, including enterprise valuations of the Company’s common stock performed by an unrelated third-party specialist, valuations of comparable
companies, sales of the Company’s convertible preferred stock to unrelated third parties, operating and financial performance, the lack of liquidity of the
Company’s capital stock, and general and industry-specific economic outlook. The board of directors intended all options granted to be exercisable at a price
per share not less than the estimated per share fair value of common stock underlying those options on the date of grant. Following the IPO, the Company
uses the closing stock price on the date of grant for the fair value of the common stock.
A summary of activity for RSAs and RSUs is as follows:
Restricted Stock Awards
Unvested as of January 1, 2019
Issued
Vested
Forfeited/Cancelled
Unvested as of December 31, 2019
Number of shares
312,500
—
(312,500)
—
—
No RSA’s were issued in 2019 and the weighted average grant date fair value of the RSAs issued during the year ended December 31, 2018 was
$1.37. The fair value of the RSAs vested during the periods ended December 31, 2019, 2018 and 2017 was $66, $2,784 and $0, respectively.
Restricted Stock Units
No RSUs were issued in 2019 or 2018 and no RSU’s were unvested at December 31, 2019 or 2018. The fair value of the RSUs vesting during the
periods ended December 31, 2019, 2018 and 2017 was $0, $69 and $69, respectively.
As of December 31, 2019, there was a total of $3,463, $0 and $0 of unrecognized compensation costs related to non-vested stock option awards,
RSAs and RSUs, respectively.
73
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 10 — Share-Based Payment Awards (continued)
In December 2018, the Company’s board of directors adopted an initial offering of the Company’s common stock under the Company’s 2018
Employee Stock Purchase Plan (the “ESPP”). The Company’s ESPP provides for an initial reserve of 150,000 shares and this reserve is automatically
increased on January 1 of each year by the lesser of 1% of the outstanding common shares at December 31 of the preceding year or 150,000 shares, subject to
reduction at the discretion of the Company’s board of directors.
The initial offering began on December 17, 2018 and ended on December 10, 2019. The initial offering consisted of two purchase periods, with the
first purchase period ending on June 10, 2019 and the second purchase period ending on December 10, 2019. The terms of the ESPP permit employees of the
Company to use payroll deductions to purchase stock at a price per share that is at least the lesser of (1) 85% of the fair market value of a share of common
stock on the first date of an offering or (2) 85% of the fair market value of a share of common stock on the date of purchase. After the initial offering period,
subsequent twelve-month offering periods automatically commence over the term of the ESPP on the day that immediately follows the conclusion of the
preceding offering, each consisting of two purchase periods approximately six months in duration ending on or around June 10 and December 10 each year.
The Company recorded an expense of $112 and $5 in 2019 and 2018, respectively, related to the ESPP. The weighted average grant date fair value of
share awards in 2019 and 2018 was $2.56 and $2.59 per share, respectively. Employees contributed $247 and $8 to the ESPP during 2019 and 2018,
respectively. Of these amounts, $16 and $8 at December 31, 2019 and 2018, respectively, is included in accrued liabilities in the accompanying balance
sheets.
Note 11 — Basic and Diluted Net Loss per Common Share
Basic and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period.
Common stock equivalents (using the treasury stock and “if converted” method) from stock options, unvested RSAs and RSUs, warrants and convertible
preferred stock at December 31, 2019, 2018 and 2017 were 3,590,465, 8,262,381 and 6,977,547, respectively, and are excluded from the calculation of diluted
net loss per share because the effect is anti-dilutive. Included in the basic and diluted net loss per share calculation were RSUs awarded to directors that had
vested, but the issuance and delivery of the shares are deferred until the director retires from service as a director.
The following table shows the computation of basic and diluted net loss per common share:
Year ended
December 31,
2019
Year ended
December 31,
2018
Period from
April 27, 2017
(inception)
through
December 31, 2017
Net loss
Series A Preferred – dividends (accrued and deemed)
Net loss attributable to common stockholders
Weighted average common shares outstanding (basic and diluted)
Net loss per common share (basic and diluted)
$
$
74
(18,320)
—
(18,320)
17,760,761
(1.03)
$
$
(12,740) $
(24,489)
(37,229) $
6,417,840
(5.80) $
(7,156)
(1,483)
(8,639)
3,453,213
(2.50)
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 12 — Related Party Transactions
Harrow
Harrow was issued 3,500,000 shares of the Company’s common stock at the formation of the Company at the $0.001 par value per share price as the
paid-in-capital contribution from Harrow. The Company and Harrow signed licensing agreements for two products developed by Harrow whereby Harrow
assigned the product rights to the Company. The Company will pay Harrow a $50 milestone payment upon patent approval for each product and a royalty fee
at a rate of six percent on the net sales of those two products. On December 26, 2017, one of the products had its patent approved and a $50 milestone fee was
recognized as R&D expense by the Company in 2017 and paid to Harrow in January 2018. In July 2018, the Company determined the patent-approved
product was not viable for its portfolio of product opportunities and Harrow paid the Company $50 to cancel the licensing agreement for the one product and
retain the product rights at Harrow.
On May 6, 2019, the Company entered into an Asset Purchase Agreement (the “CT-100 Asset Purchase Agreement”) with Harrow. Pursuant to the
CT-100 Asset Purchase Agreement, the Company sold all of its right, title and interest in CT-100 to Harrow, including any such product that incorporates or
utilizes its intellectual property rights (a “Product” or, collectively, “Products”). Pursuant to the CT-100 Asset Purchase Agreement, Harrow will make certain
payments to the Company upon the achievement of certain development and commercial milestones. In addition, Harrow is required to pay the Company a
royalty in the low-single digit percentage range worldwide on a country-by-country basis on net sales for a period of the longer of 15 years from the date of
the first commercial sale of a product in a particular country or the time that a valid intellectual property claim on such Product remains in force in the
applicable country. The CT-100 Asset Purchase Agreement also contains customary representations, warranties, covenants and indemnities by the parties.
As part of the early start-up for the Company’s pharmaceutical business, key executives at Harrow received 1,500,000 shares of restricted common
stock in the Company for consulting services and certain Harrow managers also received options to purchase 130,000 shares of common stock from the
Company (20,000 of these options were forfeited in 2018). The restricted stock and stock options vested 100% after one year on April 30, 2018. The
Company recorded stock-based compensation expense of $0, $970 and $1,370 for the Harrow restricted common stock and $0, $51 and $112 for Harrow
stock options, respectively, for the periods ended December 31, 2019, 2018 and 2017 as a component of its general and administrative expenses.
Additionally, the Chief Executive Officer of Harrow is a member of the Company’s board of directors.
Chief Executive Officer
The CEO has a partial interest in several companies that the Company is working with for product development and potential marketing if the
products are approved by the FDA as detailed below.
The Company acquired the exclusive rights to sell the EM-100 product in the United States pursuant to a sales and marketing agreement (the
“Eyemax Agreement”) dated August 11, 2017 between the Company and Eyemax LLC (“Eyemax”), an entity affiliated with the Company’s CEO. The
Company also held a right of first refusal to obtain the exclusive license rights for geographic areas outside of the United States. Pursuant to the Eyemax
Agreement, the Company is responsible for all costs of testing and FDA approval of the product, other than the FDA filing fee which will be paid by Eyemax.
The Company was also responsible for commercializing the product in the United States at its expense. The Company paid Eyemax $250 upon execution of
the Eyemax Agreement, which was recorded as a component of R&D expense. Under the terms of the original agreement, the Company would pay Eyemax
$250 upon FDA approval and $500 upon the first commercial sale of the product and pay Eyemax a royalty of 10% on the net sales of all products. The
Eyemax Agreement was for an initial term of 10 years from the date of the Eyemax Agreement, subject to successive two-year renewals unless the Company
elected to terminate the Eyemax Agreement. There were no amounts due under the terms of the Eyemax Agreement as of December 31, 2019 or 2018.
75
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 12 — Related Party Transactions (continued)
On February 18, 2019, The Company entered into an Amended and Restated Agreement with Eyemax amending the Sales Agreement (the
“Amended Agreement”). Pursuant to the Amended Agreement, Eyemax sold the Company all of its right, title and interest in EM-100, including any such
product that incorporates or utilizes Eyemax’s intellectual property rights. Under the Amended Agreement, the Company assumed certain liabilities of
Eyemax under its Exclusive Development & Supply Agreement with Excelvision SAS dated as of July 11, 2013, as amended (the “Excelvision Agreement”),
with respect to certain territories and arising during certain time periods. Pursuant to the Amended Agreement, the Company remains obligated to pay
Eyemax two milestones payments: (i) one milestone payment for $250 upon regulatory approval in the territory by the FDA of the first single agent product
and (ii) one milestone payment for $500 following the first commercial sale of the first single agent product in the territory. Following payment of the
milestones, the Company is entitled to retain all of the non-royalty transaction revenues and royalties up to $2,000 (the “Recovery Amount”). After the
Company has retained the full Recovery Amount, it is entitled to retain half of all royalty and non-royalty transaction revenue. The Amended Agreement also
contains customary representations, warranties, covenants and indemnities by the parties. The EM-100 asset and its associated product rights were sold to
Bausch on February 18, 2019 and future potential royalties on Bausch sales of EM-100, pending an FDA approval for EM-100, will be split between Eyemax
and the Company. There were no amounts due under the terms of the Amended Agreement as of December 31, 2019 or 2018.
The Company acquired the exclusive rights to sell the DS-100 product in the United States pursuant to an exclusive development and supply
agreement (the “Andersen Agreement”) dated July 9, 2017 between the Company and Andersen Pharma, LLC, an entity affiliated with the CEO
(“Andersen”). The Company also holds an option to purchase the DS-100 product and all related intellectual property and government approvals at a price of
one dollar. Pursuant to the Andersen Agreement, Andersen is responsible for obtaining FDA approval at its expense and manufacturing the product for sale to
the Company at its cost. The Company is responsible for commercializing the product in the United States at its expense. The Company paid Andersen $750
upon execution of the Andersen Agreement, which was recorded as a component of R&D expense and will pay Andersen $750 upon successful completion of
three registration batches of product, $750 upon submission of a New Drug Application (“NDA”) and $750 upon FDA approval. The Company will also pay
Andersen 50% of the net profit from the sale of the product. The Andersen Agreement is for an initial term of five years from the first commercial sale of the
product, subject to successive two-year renewals unless either party elects to terminate the Andersen Agreement. There were no amounts due under the terms
of the Andersen Agreement as of December 31, 2019 or 2018. The aforementioned option to purchase the product and all related intellectual property and
government approvals was considered to represent variable interest in the affiliated entity. The affiliated entity was not considered to be a variable interest
entity.
The Company acquired the DS-200 product and all related intellectual property and government approvals pursuant to an asset purchase agreement
(the “Selenix Agreement”) dated June 23, 2017 between the Company and Selenix LLC (“Selenix”), an entity affiliated with the Company’s CEO. Pursuant
to the Selenix Agreement, the Company paid Selenix $1,500 at signing, which was recorded as a component of R&D expense and paid $1,500 in April 2019
upon submission of an NDA on March 13, 2019 which was reflected as a component of R&D expense for the nine-month period ended September 30, 2019.
The Company will pay $1,000 upon FDA approval of the DS-200 product. The Company has also agreed to pay Selenix 50% of the net profit from the sale of
the product for the first 10 years following the date of the Selenix Agreement. There were no amounts due under the terms of the Selenix Agreement as of
December 31, 2019 or 2018.
Note 13 — Leases
Effective January 1, 2019, the Company adopted ASC 842, which requires an entity to recognize a right-of-use (“ROU”) asset and a lease liability on
the balance sheet for substantially all leases, including operating leases, using the modified retrospective approach. The Company elected to use the package
of practicable expedients which allows companies to not reassess the following: (1) the lease classification for any expired or existing leases, (2) the treatment
of initial direct costs as they related to existing leases, and (3) whether expired or existing contracts are or contain leases. The Company did not elect the use
of the hindsight practical expedient, but did elect to separate lease components from non-lease components related to its office space lease.
Upon adoption of ASC 842, the Company had non-cancellable operating leases for its office and laboratory space subject to recognition as ROU
assets. Accordingly, on January 1, 2019 the Company recorded $281 in ROU assets and $272 in operating lease liabilities (the difference of $9 related to
existing prepaid rent as of December 31, 2018). The Company has not entered into any other lease arrangements through December 31, 2019.
76
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 13 — Leases (continued)
On January 12, 2018, the Company signed an amended lease agreement to lease additional office space adjacent to its current corporate office space
in Deer Park, Illinois. The amended lease runs through the end of March 2021. On March 7, 2018, the Company entered into a lease for laboratory space at a
complex in Lake Zurich, Illinois. The lease commenced on March 7, 2018 and runs through the end of February 2021.
The Company does not have any lease contracts that contain: (1) an option to extend that the Company is reasonably certain to exercise, (2) an
option to terminate that the Company is reasonably certain not to exercise, or (3) an option to extend (or not to terminate) in which exercise of the option is
controlled by the lessor. Additionally, the Company does not have any leases with residual value guarantees or material restrictive covenants. For leases
already commenced, the lease term was determined to be the remaining months in the lease term as of January 1, 2019, the date of adoption. Lease liabilities
and their corresponding right-of-use assets have been recorded based on the present value of the future lease payments over the expected lease term. One of
the Company’s lease agreements contains provisions for escalating rent payments over the term of the lease.
The Company’s leases do not contain readily determinable implicit discount rates, and therefore, the Company was required to use its incremental
borrowing rate of 7.8% to discount the future lease payments based on information available at lease commencement. The incremental borrowing rate was
estimated by determining the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to
the lease payments in a similar economic environment.
For the periods ended December 31, 2019, 2018 and 2017, the Company recorded $140, $115 and $14, respectively, in rent expense
The Company’s operating lease cost as presented in the “Research and Development” and “General and Administrative” captions in the statements
of operations was $55 and $85 for the year ended December 31, 2019. Cash paid for amounts included in the measurement of operating lease liabilities was
$120 for year ended December 31, 2019. The ROU asset amortization for year ended December 31, 2019 was $121 and is reflected in depreciation and
amortization in the Company’s statements of cash flows. As of December 31, 2019, the weighted-average remaining lease term was 1.2 years, and the
weighted-average incremental borrowing rate was 7.8%.
The table below presents the lease-related assets and liabilities recorded on the balance sheet as of December 31, 2019:
Assets
Operating lease right-of-use assets
Total leased assets
Liabilities
Operating lease liabilities, current
Operating lease liabilities, noncurrent
Total operating lease liabilities
Classification
Operating lease right-of-use assets, net
Accrued liabilities
Operating lease liabilities, net of current portion
The Company’s future lease commitments as of December 31, 2019 are as indicated below:
$
$
$
$
160
160
133
19
152
Undiscounted lease payments
Less: Imputed interest
Total lease liabilities
Total
2020
2021
$
$
$
159
(7)
152
140 $
19
The Company’s future operating lease payments as of December 31, 2018 were as follows:
$
308
$
137
$
140 $
31
Total
2019
2020
2021
77
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 14 – Income Taxes
The provision for income taxes for the Company consists of the following for the periods ended December 31, 2019, 2018 and 2017:
Current:
Federal
State
Total current expense
Deferred:
Federal
State
Change in valuation allowance
Total deferred expense
Total provision
Year ended
December 31,
2019
Year ended
December 31,
2018
Year ended
December 31,
2017
$
$
$
—
—
—
3,961
1,415
(5,376)
—
—
$
— $
—
—
1,900
679
(2,579)
—
— $
—
—
—
1,308
468
(1,776)
—
—
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes.
The significant components of the Company’s deferred tax assets as of December 31, 2019 and 2018 are as follows:
Net operating losses
Stock-based expenses
Accruals and other
Total deferred tax assets
Valuation allowance
Net deferred tax assets
December 31,
2019
December 31,
2018
$
$
8,879 $
662
190
9,731
(9,731)
— $
3,968
233
154
4,355
(4,355)
—
Based on the uncertainty of future taxable income at this time management believes a 100% valuation reserve for the $9,731 and $4,355 deferred tax
asset at December 31, 2019 and 2018, respectively, is appropriate.
A reconciliation of the statutory federal tax rate to effective tax rate is shown below:
Benefit at statutory rate
Permanent items (primarily warrants and stock compensation)
State tax benefit
Federal rate change
Other items
Establishment of valuation allowance
Income tax expense
Year ended
December 31
2019
Year ended
December 31,
2018
(21.0)%
(0.6)
(7.7)
—
—
29.3
—%
(21.0)%
6.0
(5.3)
—
—
20.3
—%
Period from
April 27, 2017
(inception)
through
December 31,
2017
(34.0)%
4.4
(5.5)
10.2
—
24.9
—%
78
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
The Tax Act significantly revised U.S. corporate income tax law by, among other things, reducing the corporate income tax rate from 34% to 21%
and implementing a modified territorial tax system. Implementation of the Tax Act resulted in a $733 charge for the revaluation of the Company’s net
deferred tax assets offset by a corresponding $733 reduction in the valuation reserve for income taxes during the period ended December 31, 2017.
The Company has a federal and state NOL carryforward of $31,151 as of December 31, 2019, of which $5,652 will begin to expire in 2037 and
2039, respectively. Under the Tax Act, federal NOLs incurred in taxable years ending after December 31, 2017, may be carried forward indefinitely, but the
deductibility of federal NOLs generated in tax years beginning before December 31, 2017, is limited. It is uncertain if and to what extent various states will
conform to the Tax Act.
In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a
corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change (by value) in its equity ownership over a three-year
period, the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-
change income may be limited. The Company is currently performing a study to determine if it has triggered an “ownership change” limitation and tax
attributions will be adjusted when the study is complete, if required.
Note 15 - Employee Savings Plan
The Company established an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code, effective January 1, 2018. The plan
allows participating employees to deposit into tax deferred investment accounts up to 100% of their salary, subject to annual limits. The Company makes
certain matching contributions to the plan in amounts up to 4% of the participants’ annual cash compensation, subject to annual limits. For the periods ended
December 31, 2019, 2018 and 2017, the Company made $113, $62 and $0 in matching contributions, respectively.
Note 16 — Commitments and Contingencies
Legal
The Company is subject to legal proceedings and claims that may arise in the ordinary course of business. The Company is not aware of any pending
or threatened litigation matters at this time that may have a material impact on the operations of the Company.
License and Product Development Agreements
The Company has entered into various agreements in addition to those discussed above which are described below.
The Company acquired the exclusive rights to sell the DS-300 product in the United States pursuant to a sales and marketing agreement dated
November 17, 2017 with an unaffiliated third party (the “Sales Agreement”). Pursuant to the Sales Agreement, the licensor is responsible for obtaining FDA
approval, at its expense, and the Company is responsible for commercializing the product in the United States at its expense. The Company was to pay the
third party 50% of the net profit from the sale of the product, however, in February 2020, it executed an amendment to the Sales and Marketing Agreement.
Under the revised terms, the Company will be responsible for paragraph IV related litigation and will be entitled to 62.5% of product profit. The initial term is
for the first 10 years following the first commercial sale of the product.
The Company acquired the exclusive license to develop, manufacture and sell ET-103 in the United States pursuant to an Exclusive License and
Supply Agreement dated August 3, 2018 between the Company and Liqmeds Worldwide Limited (“LMW”), an unaffiliated entity. Pursuant to the agreement,
the Company will be responsible for, and will own, all regulatory filings and approvals at its expense, provided that it shall have the right to recoup 35% of
any regulatory filing fees from the initial profits from the sale of ET-103 and, provided further, the licensor shall be responsible for any bioequivalence study
and shall be responsible for 60% of the costs of such study. An affiliate of the licensor shall manufacture the ET-103 and sell it to the Company at its cost. The
Company paid the licensor $350 upon execution of the agreement and will pay the licensor $1,500 upon the FDA’s acceptance of an NDA for review, $1,000
upon FDA approval, $1,500 upon issuance of patent covering ET-103 listed in the FDA’s Orange Book and $500 in the event of product sales in excess of
$10,000 in any calendar year. In addition, the Company is required to pay the licensor 35% of the net profit from product sales. The license agreement is for
an initial term of 10 years from the date of the first commercial sale of the product, subject to two-year renewals unless either party elects to terminate no less
than 12 months prior to the then current term. The agreement also contains customary representations, warranties, covenants and indemnities by the parties.
79
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 16 — Commitments and Contingencies (continued)
On January 23, 2019 the Company entered into a Licensing and Supply Agreement (the “Agreement”) with LMW for ET-104 oral liquid, a
development stage product candidate (“ET-104”). Pursuant to the terms of the Agreement, the Company will be responsible for regulatory and marketing
activities. LMW will be responsible for development and manufacturing of ET-104. The Company paid the licensor $350 upon execution of the Agreement
and an additional $350 after receiving successful bioequivalence study results, and will pay $325 upon the FDA’s acceptance of an NDA for review, $325
upon FDA approval of the NDA, $650 upon issuance of patent covering ET-104 listed in the FDA’s Orange Book and $500 in the event that product sales in
excess of $10,000 are achieved within a calendar year. In addition, the Company is required to pay the licensor 35% of the net profit from product sales. The
Agreement is for an initial term of 10 years from the date of the first commercial sale of the product. The Company will retain sole ownership of the NDA
after expiration of the Agreement
On February 8, 2019, the Company entered into an Exclusive Licensing and Supply Agreement (the “ET-202 License Agreement”) with Sintetica
SA (“Sintetica”) for marketing rights in the United States to Biorphen® which is used for the treatment of clinically important hypotension resulting primarily
from vasodilation in the setting of anesthesia. The product was submitted to the FDA for review and subsequently received FDA approval on October 21,
2019. Pursuant to the terms of the ET-202 License Agreement, the Company will be responsible for marketing activities and Sintetica is responsible for
development, manufacturing, and regulatory activities related to obtaining regulatory approval. The Company paid Sintetica a licensing payment of $2,000
upon execution of the ET-202 License Agreement and $750 upon the commencement of commercial product shipments. Sintetica will supply Biorphen to the
Company at its direct costs and the Company will retain 5% of net sales as a marketing fee. Sintetica is entitled to receive the first $500 of product profits. All
additional profit will be split 50% to the Company and 50% to Sintetica. The ET-202 License Agreement has a ten-year term from the first commercial sale of
Biorphen which occurred in November 2019.
On February 8, 2019, the Company also entered into an Exclusive Licensing and Supply Agreement (the “ET-203 License Agreement”) with
Sintetica for marketing rights in the United States to ET-203, an injectable product candidate for use in the hospital setting. Pursuant to the terms of the ET-
203 License Agreement, the Company will be responsible for marketing activities and Sintetica will be responsible for development, manufacturing, and
regulatory activities related to obtaining regulatory approval. The Company paid Sintetica a licensing payment of $1,000 upon execution of the ET-203
License Agreement which was refunded to Eton in early 2020 due to the FDA not accepting the ET-203 file submission by Sintetica. The refund was reflected
as a component of prepaid and other current assets on the Company’s balance sheet at December 31, 2019. The Company expects the submission will be
successfully resubmitted in the near future and will pay the $1,000 milestone at that time. The Company will pay $750 upon FDA approval and the
commercial sale of the product candidate. Upon approval, Sintetica will supply ET-203 to the Company at its direct costs. The Company will retain 5% of net
sales as a marketing fee. Sintetica will be entitled to receive the first $500 of product profits. All additional profit will be split 50% to the Company and 50%
to Sintetica. The ET-203 License Agreement has a ten-year term from first commercial sale of product.
On June 12, 2019, the Company entered into an Exclusive Licensing and Supply Agreement (the “ET-105 License Agreement”) with Aucta
Pharmaceuticals, Inc. (“Aucta”) for marketing rights in the United States to ET-105, a product candidate for use as an adjunct therapy for partial seizures,
primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older. Pursuant to the terms
of the ET-105 License Agreement, the Company will be responsible for marketing activities and Aucta will be responsible for development, manufacturing,
and regulatory activities related to obtaining regulatory approval. The Company paid Aucta a licensing payment of $2,000 in August 2019 upon receiving an
acceptance for review letter from the FDA and will pay $2,000 upon FDA approval and commercial sales of the product candidate and another $1,000 upon
issuance of an Orange-book listed patent. Aucta will receive a low double-digit royalty on net sales and will be entitled to receive milestone payments of up to
$18,000 based on commercial success of the product, including:
● $1,000 when net sales exceed $10 million in a calendar year
● $2,000 when net sales exceed $20 million in a calendar year
● $5,000 when net sales exceed $50 million in a calendar year
● $10,000 when net sales exceed $100 million in a calendar year
80
Eton Pharmaceuticals, Inc.
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 16 — Commitments and Contingencies (continued)
Indemnification
As permitted under Delaware law and in accordance with the Company’s Amended and Restated Bylaws, the Company is required to indemnify its
officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. The Company is also party to
indemnification agreements with its directors and officers. The Company believes the fair value of the indemnification rights and agreements is minimal.
Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements as of December 31, 2019 or 2018.
Note 17 — Summary of Unaudited Quarterly Financial Information
The following is a summary of our unaudited quarterly results for the years ended December 31, 2019 and 2018 (in thousands):
For the Quarter Ended
Revenues
Operating expenses
Net loss
Net loss attributable to common stockholders
Net loss per share attributable to common
stockholders- basic and diluted
Weighted average shares outstanding, basic
and diluted
Revenues
Operating expenses
Net loss
Net loss attributable to common stockholders
(1)
Net loss per share attributable to common
stockholders- basic and diluted
Weighted average shares outstanding, basic
and diluted
March 31,
2019
500
8,054
(7,410)
(7,410)
(0.42)
17,502
March 31,
2018
—
2,964
(3,018)
(3,724)
(1.05)
3,551
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
June 30,
2019
September 30,
2019
(in thousands except per share amounts)
December 31,
2019
Total Year
2019
$
$
$
$
$
—
3,349
(3,249)
(3,249)
(0.18)
17,733
— $
5,042 $
(4,965) $
(4,965) $
459 $
2,662 $
(2,696) $
(2,696) $
959
19,107
(18,320)
(18,320)
(0.28) $
(0.15) $
(1.03)
17,878
17,924
17,761
For the Quarter Ended
June 30,
2018
September 30,
2018
(in thousands except per share amounts)
December 31,
2018
Total Year
2018
$
$
$
$
$
—
2,697
(3,082)
(3,804)
(0.79)
4,786
— $
2,374 $
(2,910) $
— $
2,286 $
(3,730) $
—
10,321
(12,740)
(3,639) $
(26,062) $
(37,229)
(0.65) $
(2.24) $
(5.80)
5,615
11,640
6,418
(1) Net loss attributable to common stockholders for the quarter ended December 31, 2018 included $21,747 related to deemed dividends for the
beneficial conversion feature of the Company’s redeemable convertible preferred stock.
Note 18 — Subsequent Events
The Company has performed an evaluation of events occurring subsequent to December 31, 2019 through the filing date of this Annual Report and
determined that no subsequent events have occurred that would require recognition in the financial statements or disclosures in the notes thereto.
81
Eton Pharmaceuticals, Inc.
Schedule II
Valuation and Qualifying Accounts
(in thousands)
For the year ended December 31, 2019
Accounts receivable allowances (1)
For the year ended December 31, 2018
Accounts receivable allowances (1)
For the period ended December 31, 2017
Accounts receivable allowances (1)
Balance at
Beginning of
Period
Additions
Deductions
Balance at
End of Period
$
$
$
—
—
—
$
$
$
116
—
—
$
$
$
— $
116
— $
— $
—
—
(1) Allowances are for chargebacks, prompt payment discounts, distribution fees, and returns & allowances related to Biorphen product sales.
82
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
PART II (CONTINUED)
None.
Item 9A. Controls and Procedures
Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are
designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our
management, including our principal executive officer and our principal financial officer, to allow timely decisions regarding required disclosure.
The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there
can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
With respect to the year ended December 31, 2019, under the supervision and with the participation of our management, we conducted an evaluation
of the effectiveness of the design and operations of our disclosure controls and procedures. Based upon this evaluation, the Company’s principal executive
officer and principal financial officer have concluded that the Company’s disclosure controls and procedures are effective.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting for our Company, as such term is
defined in Rule 13a-15(f) under the Exchange Act. Our management conducted an evaluation, with the participation of our principal executive officer and
principal financial officer, of the effectiveness of our internal control over financial reporting as of December 31, 2019, based on the criteria set forth in the
2013 Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation,
our management concluded that our internal control over financial reporting was effective as of December 31, 2019.
This report does not include an attestation report of our independent registered public accounting firm regarding our internal control over financial
reporting, in accordance with applicable SEC rules that permit us to provide only management’s report in this report.
Changes in Internal Control over Financial Reporting
There has not been any change in our internal control over financial reporting (as defined in Rules 13a-15(f) under the Exchange Act) that occurred
during the quarter ended December 31, 2019 that has materially affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including our principal executive officer and principal financial officer, do not expect that our disclosure controls or our internal
control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only
reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if
any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur
because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by
management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and
there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of
controls effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in
the degree of compliance with policies or procedures.
Item 9B. Other Information
Not applicable.
83
Item 10. Directors, Executive Officers and Corporate Governance
PART III
The information required by this item and not set forth below will be set forth in the section headed “ Election of Directors “ and “ Executive
Officers “ in our Proxy Statement for our 2019 Annual Meeting of Stockholders (“Proxy Statement”), to be filed with the SEC within 120 days after the end
of the fiscal year ended December 31, 2018, and is incorporated herein by reference.
We have adopted a code of ethics for directors, officers (including our principal executive officer, principal financial officer and principal accounting
officer) and employees, known as the Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics is available on our website at
http://ir.etonpharma.com under the Corporate Governance section of our Investor Relations page. We will promptly disclose on our website (i) the nature of
any amendment to the policy that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons
performing similar functions and (ii) the nature of any waiver, including an implicit waiver, from a provision of the policy that is granted to one of these
specified individuals that is required to be disclosed pursuant to SEC rules and regulations, the name of such person who is granted the waiver and the date of
the waiver.
Item 11. Executive Compensation
The information required by this item will be set forth in the section headed “ Executive Compensation “ in our Proxy Statement and is incorporated
herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item will be set forth in the section headed “ Security Ownership of Certain Beneficial Owners and Management “
in our Proxy Statement and is incorporated herein by reference.
The information required by Item 201(d) of Regulation S-K will be set forth in the section headed “ Executive Compensation “ in our Proxy
Statement and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item will be set forth in the section headed “ Transactions With Related Persons “ in our Proxy Statement and is
incorporated herein by reference.
Item 14. Principal Accountant Fees and Services
The information required by this item will be set forth in the section headed “ Ratification of Selection of Independent Registered Public Accounting
Firm “ in our Proxy Statement and is incorporated herein by reference.
84
Item 15. Exhibits, Financial Statement Schedules
(1) Index to Financial Statements
PART IV
The following financial statements of Eton Pharmaceuticals, Inc. and the Report of the Independent Registered Public Accounting Firm are included
in Part II, Item 8 of this Annual Report:
Report of Independent Registered Public Accounting Firm
Balance Sheets as of December 31, 2019 and 2018
Statements of Operations for the periods ended December 31, 2019, 2018 and 2017
Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the periods ended December 31, 2019, 2018 and 2017
Statements of Cash Flows for the periods ended December 31, 2019, 2018 and 2017
Notes to the Financial Statements
(2) Financial Statement Schedules
The following financial statement schedule of Eton Pharmaceuticals, Inc. is filed as part of this Annual Report on Form 10-K and should be read in
conjunction with the financial statements of Eton Pharmaceuticals, Inc.
Schedule II: Valuation and Qualifying Accounts
All other schedules are omitted because they are not applicable, or the required information is shown in the financial statements or notes thereto.
(3) Exhibits
The following exhibits have been or are being filed herewith and are numbered in accordance with Item 601 of Regulation S-K:
EXHIBIT INDEX
Exhibit
No.
3.1
3.2
4.1
4.2
4.3
4.4
4.5
10.1
Description
Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current
Report on Form 8-K, filed November 20, 2018).
Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K,
filed November 20, 2018).
Specimen Certificate representing shares of common stock of Registrant (incorporated by reference to Exhibit 4.1 to the Registrant’s
Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
Warrant dated May 4, 2017 issued to Liquid Patent Advisors, LLC (incorporated by reference to Exhibit 4.2 to the Registrant’s Registration
Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
Warrant dated June 26, 2017 issued to National Securities Corporation (incorporated by reference to Exhibit 4.3 to the Registrant’s
Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
Form of Underwriter’s Warrant (incorporated by reference to Exhibit 4.4 to the Registrant’s Registration Statement on Form S-1, as amended
(File No. 333-226774), originally filed August 10, 2018).
Warrant dated November 13, 2019 issued to SWK Holdings LLC.
Registration Rights Agreement dated June 19, 2017 by and among the Registrant and certain of its stockholders (incorporated by reference to
Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
85
Exhibit
No.
10.2†
10.3†
Description
Asset Purchase Agreement (DS-200) dated June 23, 2017 between Selenix, LLC and the Registrant (incorporated by reference to Exhibit 10.5
to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
Exclusive Development and Supply Agreement (DS-100) dated July 9, 2017 between Andersen Pharma, LLC and the Registrant
(incorporated by reference to Exhibit 10.6 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774),
originally filed August 10, 2018).
10.4
Amended and Restated Agreement relating to sales and marketing dated February 18, 2019 between the Registrant and Eyemax, LLC
(incorporated by reference to Exhibit 10.6 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019)
10.5†
Sales/Marketing Agreement (DS-300) dated November 17, 2017 by and among AL Pharma, Inc., SCS National, LLC, Dry Creek Project,
LLC and the Registrant (incorporated by reference to Exhibit 10.9 to the Registrant’s Registration Statement on Form S-1, as amended (File
No. 333-226774), originally filed August 10, 2018).
10.6+
Eton Pharmaceuticals, Inc. 2017 Stock Incentive Plan (incorporated by reference to Exhibit 10.10 to the Registrant’s Registration Statement
on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
10.7+
10.8+
10.9
Offer Letter Agreement by and between the Registrant and Sean E. Brynjelsen, dated as of May 17, 2017 (incorporated by reference to
Exhibit 10.12 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
Offer Letter Agreement by and between the Registrant and W. Wilson Troutman, dated as of June 27, 2017 (incorporated by reference to
Exhibit 10.13 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
Exclusive License and Supply Agreement (ET-103) dated August 3, 2018 between the Registrant, Liqmeds Worldwide Limited and LM
Manufacturing, Ltd. (incorporated by reference to Exhibit 10.14 to the Registrant’s Registration Statement on Form S-1, as amended (File No.
333-226774), originally filed August 10, 2018).
10.10+
Eton Pharmaceuticals, Inc. 2018 Stock Incentive Plan (incorporated by reference to Exhibit 10.15 to the Registrant’s Registration Statement
10.11+
on Form S-1, as amended (File No. 333-226774), originally filed August 10, 2018).
2018 Equity Incentive Plan (incorporated by reference to Exhibit 10.16 to the Registrant’s Registration Statement on Form S-1, as amended
(File No. 333-226774), originally filed August 10, 2018).
86
Exhibit No. Description
10.12+
10.13
2018 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.17 to the Registrant’s Registration Statement on Form S-1, as
amended (File No. 333-226774), originally filed August 10, 2018).
Amendment No. 1 dated August 29, 2018 to Sales/Marketing Agreement (DS-300) dated November 17, 2017 between AL Pharma, Inc. and
the Registrant (incorporated by reference to Exhibit 10.18 to the Registrant’s Registration Statement on Form S-1, as amended (File No. 333-
226774), originally filed August 10, 2018).
10.14.
23.1
24.1
31.1
Credit Agreement dated as of November 13, 2019, by and among the Company and SWK Funding LLC
Consent of KMJ Corbin & Company LLP, Independent Registered Public Accounting Firm.
Power of Attorney. Reference is made to the signature page hereto.
Certification of President and Chief Executive Officer (Principal Executive Officer), pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
31.2
Certification of Chief Financial Officer (Principal Financial and Accounting Officer), pursuant to Section 302 of the Sarbanes-Oxley Act of
2002.
32.1*
Certifications of President and Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial and
Accounting Officer), pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101
The following financial information from the Company’s Annual Report on Form 10-K for the period ended December 31, 2019, formatted in
Extensible Business Reporting Language (XBRL): (i) the Balance Sheets, (ii) the Statements of Operations, (iii) the Statement of Redeemable
Convertible Preferred Stock and Stockholders’ Equity (Deficit), (iv) the Statements of Cash Flows and (v) Notes to Financial Statements.
†
+
*
Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
Indicates management compensatory plan, contract or arrangement.
These certifications are being furnished solely to accompany this Annual Report pursuant to 18 U.S.C. Section 1350, and are not being filed for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the
Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
87
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Annual Report to be signed on
its behalf by the undersigned thereunto duly authorized.
SIGNATURES
March 5, 2020
ETON PHARMACEUTICALS, INC.
By: /s/ Sean E. Brynjelsen
Sean E. Brynjelsen
President and Chief Executive Officer
(Principal Executive Officer)
By: /s/ W. Wilson Troutman
W. Wilson Troutman
Chief Financial Officer
(Principal Financial and Accounting Officer)
88
POWER OF ATTORNEY
Each person whose signature appears below constitutes and appoints Sean Brynjelsen, his true and lawful attorney-in-fact and agent, each with full
power of substitution and resubstitution, severally, for him and in his name, place and stead, in any and all capacities, to sign this Annual Report on Form 10-
K of Eton Pharmaceuticals, Inc., and any or all amendments thereto, and to file the same, with all exhibits thereto and other documents in connection
therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby
ratifying and confirming all that said attorney-in-fact and agent or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof. This
power of attorney may be executed in counterparts.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Annual Report to be signed on
its behalf by the undersigned thereunto duly authorized.
Signature
Title
/s/ Sean E. Brynjelsen
Sean E. Brynjelsen
President, Chief Executive Officer, and Director
(Principal Executive Officer)
/s/ W. Wilson Troutman
W. Wilson Troutman
Chief Financial Officer, Treasurer and Secretary
(Principal Financial and Accounting Officer)
/s/ Mark L. Baum
Mark L. Baum
/s/ Charles J. Casamento
Charles J. Casamento
/s/ Paul V. Maier
Paul V. Maier
/s/ Norbert G. Riedel, Ph.D.
Norbert G. Riedel, Ph.D.
Director
Director
Director
Director
89
Date
March 5, 2020
March 5, 2020
March 5, 2020
March 5, 2020
March 5, 2020
March 5, 2020
Exhibit 4.5
Exhibit 10.14
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in Registration Statement Nos. 333-228493 and 333-230572 on Form S-8 and Registration Statement
No. 333-235329 on Form S-3 of our report dated March 5, 2020, relating to the financial statements and financial statement schedule of Eton
Pharmaceuticals, Inc., appearing in this Annual Report on Form 10-K of Eton Pharmaceuticals, Inc. for the year ended December 31, 2019.
Exhibit 23.1
/s/ KMJ Corbin & Company LLP
Costa Mesa, California
March 5, 2020
Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Sean E. Brynjelsen, certify that:
1. I have reviewed this Annual Report on Form 10-K of Eton Pharmaceuticals, Inc.;
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 registrant as of, and for, the periods presented in this report;
4. The registrant’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)) for the registrant 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 registrant, 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;
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
(c) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially
affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: March 5, 2020
By: /s/ Sean E. Brynjelsen
Sean E. Brynjelsen
Principal Executive Officer
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, W. Wilson Troutman, certify that:
1. I have reviewed this Annual Report on Form 10-K of Eton Pharmaceuticals, Inc.;
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 registrant as of, and for, the periods presented in this report;
4. The registrant’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)) for the registrant 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 registrant, 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) Evaluated the effectiveness of the registrant’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
(c) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially
affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting.
Date: March 5, 2020
By: /s/ W. Wilson Troutman
W. Wilson Troutman
Principal Financial and Accounting Officer
ETON PHARMACEUTICALS, INC.
PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”), and Section 1350
of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Sean E. Brynjelsen, President and Chief Executive Officer of Eton Pharmaceuticals,
Inc. (the “Company”), and W. Wilson Troutman, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:
1. The Company’s Annual Report on Form 10-K for the period ended December 31, 2019, to which this Certification is attached as Exhibit 32.1 (the
“Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
2. The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the
Company.
IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 5th day of March, 2020.
/s/ Sean E. Brynjelsen
Sean E. Brynjelsen
President and Chief Executive Officer
(Principal Executive Officer)
/s/ W. Wilson Troutman
W. Wilson Troutman
Chief Financial Officer
(Principal Financial and Accounting Officer)
*
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be
incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or
after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.