O M E R O S
C O R P O R A T I O N
2 0 1 9
A N N U A L
R E P O R T
LETTING SCIENCE LEAD THE WAY
April 29, 2020
Dear Shareholders:
29APR202007280329
Omeros made tremendous progress during 2019. Our achievements throughout the year
improved the lives of patients and their families, and we expect that we will soon deliver
to the market another first-in-class product — narsoplimab.
Narsoplimab is our fully human antibody against MASP-2, the effector enzyme of the lectin
pathway of complement. We completed our pivotal registration trial of narsoplimab in
hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
The response rates, both in the intent-to-treat and protocol-specified dosing groups,
multiply exceed the FDA-agreed threshold for efficacy on this rigorous primary endpoint.
The secondary endpoint of 100-day survival is also compelling — 68 percent across all
patients receiving at least one dose of narsoplimab, 83 percent in the protocol-specified
dosing group, and 93 percent in complete responders. The rolling biologics license
application (BLA) for narsoplimab in HSCT-TMA began in October with the submission of
the non-clinical sections and will be followed next by the first portion of the chemistry,
manufacturing and controls section. Process validation lots, a requirement for the BLA,
and our initial commercial supply have already been manufactured. Marketing
preparations for the anticipated commercial launch are well underway.
FDA has granted narsoplimab Breakthrough Therapy designation for HSCT-TMA and for
immunoglobulin A (IgA) nephropathy — a singular distinction in each indication.
Narsoplimab is further unique in that we believe it is the only drug that can receive full
regulatory approval for IgA nephropathy based on assessing proteinuria rather than
evaluating glomerular filtration rate, which requires a much longer duration of follow-up.
Our Phase 3 program evaluating narsoplimab for the treatment of IgA nephropathy is
advancing, and enrollment accelerated throughout 2019. The primary endpoint is
improvement in proteinuria. The Phase 3 trial in atypical hemolytic uremic syndrome also
progressed last year and is ongoing at multiple international sites. Across all clinical trials,
narsoplimab has been well tolerated, and no meaningful safety signal has been observed.
With narsoplimab, our lectin pathway inhibitor, Omeros is emerging as a world leader in
the development of complement-targeting therapeutics. And we expect that OMS906, our
antibody against MASP-3, will soon further strengthen that standing. Along with others in
industry and in the complement research community, we believe that MASP-3 is the key
activator and premier drug target in the alternative pathway. While we plan to pursue
alternative pathway indications broadly with OMS906, our initial focus is paroxysmal
nocturnal hemoglobinuria (PNH), a life-threatening hematologic disease. Expected to
have substantial safety and dosing advantages over other drugs on the market or in
development for PNH, we look forward to the clinical entry of OMS906, slated for this
summer. Rounding out our complement franchise, we are developing products aimed at
lifecycle management including a long-acting second-generation antibody against MASP-2
as well as small-molecule inhibitors of MASP-2 and MASP-3.
NEXT-GENERATION THERAPEUTICS TRANSFORMING PATIENT CARE TODAY(cid:1)
Helping to fund the achievements in our complement franchise and the rest of our
pipeline, our FDA-approved ophthalmic product OMIDRIA(cid:1) (phenylephrine and ketorolac
intraocular solution) 1%/0.3% maintained strong growth throughout 2019, ending the year
with record annual net sales of $112 million. The increased revenues reflected broadening
reimbursement from Medicare Advantage and commercial payers as well as expanding
utilization across all patient segments and all sites of care. Facilitating and streamlining
billing and reimbursement, in October OMIDRIA received from CMS a permanent product-
specific J-code.
The current pass-through reimbursement status for OMIDRIA in Medicare Part B
beneficiaries is set to expire on September 30, 2020, and we continue to pursue multiple
legislative and administrative avenues to secure separate payment for OMIDRIA beyond
that date. This includes the bipartisan Non-Opioids Prevent Addiction in the Nation
(NOPAIN) Act. Introduced in the fourth quarter of 2019 in the House of Representatives
and in the Senate, the NOPAIN Act has strong bipartisan and leadership support in both
chambers of Congress. If enacted, the NOPAIN Act would provide non-opioid treatment
alternatives like OMIDRIA with separate payment status for five years. We are optimistic
that CMS will continue to reimburse OMIDRIA appropriately, allowing access to the drug
for patients who need it, and also are planning alternative market strategies should our
legislative and administrative efforts prove unsuccessful. While elective surgery has been
curtailed during the COVID-19 outbreak, we expect that ASCs and hospital outpatient
departments will re-open soon with a backlog of postponed procedures, increasing surgical
volumes. Given surgeons’ and facility administrators’ response to our uniformly compelling
clinical data and expanding reimbursement across Medicare Advantage and commercial
payers, we believe the value story for OMIDRIA will remain strong.
Turning to the rest of our deep pipeline of first-in-class products, in 2019 we successfully
completed a Phase 1 trial in our phosphodiesterase 7 (PDE7) inhibitor program to treat
addictions and compulsions. Well tolerated with a good safety profile in the study, OMS527
showed pharmacokinetics consistent with once-daily dosing. While animal data show that
OMS527 could be effective widely across drugs of abuse and compulsive disorders, our
initial focus is nicotine addiction for which we are planning a Phase 2 development
program.
In our G protein-coupled receptor (GPCR) program, last fall Omeros scientists received the
2019 Prix Galien Canada Research Award. Considered the Nobel Prize of pharmaceutical
research, it recognized our team’s discoveries based on our high-throughput compound
screening technology for orphan GPCRs. Using that proprietary technology, to date we
have identified functionally active compounds for 54 of the 81 Class A orphan GPCRs.
GPR174 is one of our high-priority targets. Last year we announced a series of GPR174
discoveries around which we are building a broad and exclusive intellectual property
position. These include a new cancer immunity axis controlled by GPR174 as well as the
receptor’s link to the tumor microenvironment and the ability of GPR174 to suppress the
body’s anti-tumor response. ‘‘Tumor immunity’’ — a tumor’s ability to protect itself from
the body’s tumor-killing mechanisms — is tied to the tumor microenvironment and has
proven to be a major hurdle for cancer therapies, including checkpoint inhibitors. Despite
NEXT-GENERATION THERAPEUTICS TRANSFORMING PATIENT CARE TODAY(cid:1)
this, sales of checkpoint inhibitors reached $22 billion last year. GPR174 inhibition not
only suppresses tumor immunity but acts synergistically with inhibitors of the adenosine
pathway, an important immuno-oncology target. We expect that a GPR174 inhibitor could
be administered alone or in combination with adenosine pathway and/or checkpoint
inhibitors to enhance their tumor-killing effects. Either way, our GPR174 program could
deliver a new immunotherapy approach that overcomes the unsolved challenges posed by
tumor immunity.
At Omeros we let science lead the way, and it’s working. We are grateful to our valued
and dedicated employees, research collaborators, investigators and clinical trial
participants and their families, without whom our achievements would not be possible.
We look forward to even greater success in 2020 and beyond.
On behalf of our board of directors and employees, I would like to thank you, our
shareholders, for your continued support. We hope that you and yours are safe and
healthy.
Sincerely,
29APR202007131615
Gregory A. Demopulos, M.D.
Chairman & Chief Executive Officer
NEXT-GENERATION THERAPEUTICS TRANSFORMING PATIENT CARE TODAY(cid:1)
FORM 10-K
2019
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
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: 001-34475
OMEROS CORPORATION
(Exact name of registrant as specified in its charter)
Washington
(State or other jurisdiction of
incorporation or organization)
91-1663741
(I.R.S. Employer
Identification Number)
201 Elliott Avenue West
Seattle, Washington 98119
(Address of principal executive offices and zip code)
(206) 676-5000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, par value $0.01 per share
Trading Symbol
OMER
Name of each exchange on which registered
The Nasdaq Stock Market LLC
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
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934, as
amended, during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes No
Indicate by check mark whether the registrant has submitted electronically 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 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
☐
☐
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.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant as of the last business day of the registrant’s most
recently completed second fiscal quarter was $729,297,324.
As of February 25, 2020, the number of outstanding shares of the registrant’s common stock, par value $0.01 per share, was 54,205,177.
DOCUMENTS INCORPORATED BY REFERENCE
Specified portions of the registrant’s proxy statement with respect to the 2020 Annual Meeting of Shareholders to be held June 5, 2020, which is to be filed
pursuant to Regulation 14A within 120 days after the end of the registrant’s fiscal year ended December 31, 2019, are incorporated by reference into Part III of this
Form 10-K.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934 (the “Exchange
Act”), which are subject to the “safe harbor” created by those sections for such statements. Forward-looking statements
are based on our management’s beliefs and assumptions and on information currently available to our management. All
statements other than statements of historical fact are “forward-looking statements.” Terms such as “anticipate,”
“believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,”
“should,” “target,” “will,” “would,” and similar expressions and variations thereof are intended to identify forward-
looking statements, but these terms are not the exclusive means of identifying such statements. Examples of these
statements include, but are not limited to, statements regarding:
•
•
•
•
•
•
•
•
•
our expectations related to obtaining permanent separate or similar reimbursement for OMIDRIA®
(phenylephrine and ketorolac intraocular solution) 1%/0.3% from the Centers for Medicare & Medicaid
Services (“CMS”) for periods after September 30, 2020, and our expectations regarding reimbursement
coverage for OMIDRIA by commercial and government payers;
our expectations related to demand for OMIDRIA from wholesalers, ambulatory surgery centers (“ASCs”), and
hospitals, and our expectations regarding OMIDRIA product sales;
our plans for marketing and distribution of OMIDRIA and our estimates of OMIDRIA chargebacks and rebates,
distribution fees and product returns;
our expectations regarding the clinical, therapeutic and competitive benefits and importance of OMIDRIA and
our product candidates;
our ability to design, initiate and/or successfully complete clinical trials and other studies for our products and
product candidates and our plans and expectations regarding our ongoing or planned clinical trials, including
for our lead MASP-2 inhibitor, narsoplimab, and for our other investigational candidates, including OMS527
and OMS906;
our estimates regarding how long our existing cash, cash equivalents, short-term investments and revenues will
be sufficient to fund our anticipated operating expenses, capital expenditures and debt service obligations;
our expectations regarding the clinical, therapeutic and competitive benefits of OMIDRIA and our product
candidates;
in our narsoplimab clinical programs, our expectations regarding: whether enrollment in ongoing and planned
clinical trials will proceed as expected; whether we can capitalize on the financial and regulatory incentives
provided by orphan drug designations granted by the U.S. Food and Drug Administration (“FDA”), the
European Commission (“EC”), or the European Medicines Agency (“EMA”); and whether we can capitalize on
the financial and regulatory incentives provided by fast-track and/or breakthrough therapy designations granted
by FDA;
our expectations regarding clinical plans and anticipated or potential paths to regulatory approval of
narsoplimab by FDA and/or EMA in hematopoietic stem cell transplant-associated thrombotic microangiopathy
(“HSCT-TMA”), Immunoglobulin A (“IgA”) nephropathy, and/or atypical hemolytic uremic syndrome
(“aHUS”);
• whether and when we will complete the rolling Biologics License Application (“BLA”) for narsoplimab in
HSCT-TMA and whether and when FDA will accept submission and grant accelerated or regular approval;
i
• whether and when a BLA may be filed with the FDA for narsoplimab in any other indication and whether FDA
will grant accelerated or regular approval;
• whether and when a marketing authorization application (“MAA”) may be filed with EMA for narsoplimab in
any indication, and whether EMA will grant approval for narsoplimab in any indication;
•
•
•
•
•
•
•
•
our plans for the commercial launch of narsoplimab following any regulatory approval and our estimates and
expectations regarding coverage and reimbursement for any approved products;
our anticipation that we will rely or continue to rely on contract manufacturers to manufacture OMIDRIA and
to manufacture our product candidates for purposes of clinical supply and in anticipation of potential
commercialization;
our ability to raise additional capital through the capital markets or through one or more corporate partnerships,
equity offerings, debt financings, collaborations, licensing arrangements or asset sales;
our expectations about the commercial competition that OMIDRIA and our product candidates, if
commercialized, face or may face;
the expected course and costs of existing claims, legal proceedings and administrative actions, our involvement
in potential claims, legal proceedings and administrative actions, and the merits, potential outcomes and effects
of both existing and potential claims, legal proceedings and administrative actions, as well as regulatory
determinations, on our business, prospects, financial condition and results of operations;
the extent of protection that our patents provide and that our pending patent applications will provide, if patents
are issued from such applications, for our technologies, programs, products and product candidates;
the factors on which we base our estimates for accounting purposes and our expectations regarding the effect of
changes in accounting guidance or standards on our operating results; and
our expected financial position, performance, revenues, growth, costs and expenses, magnitude of net losses
and the availability of resources.
Our actual results could differ materially from those anticipated in these forward-looking statements for many
reasons, including the risks, uncertainties and other factors described in Item 1A of Part I of this Annual Report on
Form 10-K under the heading “Risk Factors” and in Item 7 of Part II under the heading “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” and in our other filings with the Securities and Exchange
Commission (“SEC”). Given these risks, uncertainties and other factors, actual results or anticipated developments may
not be realized or, even if substantially realized, they may not have the expected consequences to or effects on our
company, business or operations. Accordingly, you should not place undue reliance on these forward-looking
statements, which represent our estimates and assumptions only as of the date of the filing of this Annual Report on
Form 10-K. You should read this Annual Report on Form 10-K completely and with the understanding that our actual
results in subsequent periods may materially differ from current expectations. Except as required by applicable law,
including the securities laws of the United States and the rules and regulations of the SEC, we assume no obligation to
update or revise any forward-looking statements contained herein, whether as a result of any new information, future
events or otherwise.
ii
OMEROS CORPORATION
ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2019
INDEX
Part I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 1. Business . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 1A. Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 1B. Unresolved Staff Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 2. Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 3. Legal Proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 4. Mine Safety Disclosures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Part II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 5. Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of
Page
1
1
29
45
45
45
45
46
46
Equity Securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 6. Selected Consolidated Financial Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations . . . . . . .
Item 7A. Quantitative and Qualitative Disclosures About Market Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 8. Financial Statements and Supplementary Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures . . . . . .
Item 9A. Controls and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 9B. Other Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Part III . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 10. Directors, Executive Officers and Corporate Governance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 11. Executive Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Shareholder
Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 13. Certain Relationships and Related Transactions, and Director Independence . . . . . . . . . . . . . . . . . .
Item 14. Principal Accounting Fees and Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Part IV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 15. Exhibits, Financial Statement Schedules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 16. Form 10-K Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
47
49
60
61
84
84
86
86
86
86
86
87
87
87
87
93
94
iii
PART I
This Annual Report on Form 10-K contains forward-looking statements reflecting our current expectations that
involve risks and uncertainties. Actual results may differ materially from those discussed in these forward-looking
statements due to a number of factors, including those set forth in the section entitled “Risk Factors” and elsewhere in
this Annual Report. Please refer to the special note regarding forward-looking statements at the beginning of this
Annual Report on Form 10-K for further information.
ITEM 1. BUSINESS
Overview
We are a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing
small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation,
complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers.
Our drug product OMIDRIA® is marketed in the United States for use during cataract surgery or intraocular lens
(“IOL”) replacement for adult and pediatric patients. We have multiple Phase 3 and Phase 2 clinical-stage development
programs in our pipeline, which are focused on: complement-mediated disorders, including HSCT-TMA, IgA
nephropathy and aHUS, as well as addiction. In addition, we have a diverse group of preclinical programs, including
GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis that we recently discovered.
Small-molecule inhibitors of GPR174 are part of our proprietary G protein-coupled receptor (“GPCR”) platform through
which we control 54 new GPCR drug targets and their corresponding compounds. We also exclusively possess a novel
antibody-generating platform. We have retained control of all commercial rights for OMIDRIA and each of our product
candidates and programs.
Commercial Product -- OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3%
Overview. OMIDRIA is approved by the FDA for use during cataract surgery or IOL replacement to maintain pupil
size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. Outside the U.S.,
we have received approval from the EC to market OMIDRIA in the European Economic Area (“EEA”), for use during
cataract surgery and other IOL replacement procedures for maintenance of intraoperative mydriasis (pupil dilation),
prevention of intraoperative miosis and reduction of acute postoperative ocular pain. OMIDRIA is a proprietary drug
product containing two active pharmaceutical ingredients (“APIs”): ketorolac, an anti-inflammatory agent, and
phenylephrine, a mydriatic, or pupil dilating, agent. Cataract and other lens replacement surgery involves replacement of
the original lens of the eye with an artificial intraocular lens. OMIDRIA is added to standard irrigation solution used
during cataract and lens replacement surgery and is delivered intracamerally, or within the anterior chamber of the eye,
to the site of the surgical trauma throughout the procedure. Preventing pupil constriction is essential for these procedures
and, if miosis occurs, the risk of damaging structures within the eye and other complications increases, as does the
operating time required to perform the procedure.
United States. We launched OMIDRIA in the U.S. in the second quarter of 2015 and sell OMIDRIA primarily
through wholesalers which, in turn, sell to ASCs and hospitals. CMS, the federal agency responsible for administering
the Medicare program, granted transitional pass-through reimbursement status for OMIDRIA in 2014, effective from
January 1, 2015 through December 31, 2017. Pass-through status allows for separate payment (i.e., outside the packaged
payment rate for the surgical procedure) under Medicare Part B. In March 2018, Congress extended pass-through
reimbursement status for a small number of drugs, including OMIDRIA, used during procedures performed on Medicare
Part B fee-for-service patients for an additional two years, running from October 1, 2018 through September 30, 2020.
We continue to pursue permanent separate reimbursement for OMIDRIA beyond the currently scheduled expiration
of pass-through reimbursement. CMS is required under the Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act to review payments under CMS’ outpatient prospective
payment system (“OPPS”) for opioids and evidence-based non-opioid alternatives for pain management with a goal to
ensure that there are not financial incentives to use opioids instead of non-opioid alternatives. In its 2020 OPPS proposed
1
rule, CMS noted that non-opioid drugs that are indicated for reduction of post-operative pain may warrant separate
payment if there is evidence to show that such drugs help to deter or avoid prescription opioid use and addiction and that
packaged payment presents a demonstrated barrier to access for such drugs. Although Omeros provided CMS with
evidence that it believes shows that OMIDRIA meets these criteria, CMS declined in its 2020 OPPS final rule to grant
separate payment to OMIDRIA beyond the expiration of its current pass-through status on September 30, 2020. CMS
also noted in the 2020 OPPS final rule that it will continue to analyze evidence and monitor utilization of OMIDRIA.
We continue to generate evidence and intend to continue pursuing administrative and legislative avenues to secure
permanent separate payment or similar reimbursement for OMIDRIA beyond September 30, 2020; however, we cannot
provide assurance that these efforts will be successful.
We continue to pursue expansion of reimbursement for OMIDRIA by Medicare Advantage and other third-party
payers. CMS assigned a permanent product-specific Healthcare Common Procedure Coding System (“HCPCS”) J-code
for OMIDRIA, which became effective October 1, 2019 and replaced the drug's former temporary HCPCS C-code.
J-codes are reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other
government payers for drugs like OMIDRIA that are administered by a physician. Benefits of the new J-code include
having one consistent billing code that can be used across all government and commercial payer plans as well as
expanding coverage in state Medicaid and commercial plans that recognize J-codes, but not C-codes, for reimbursement
and enabling access to the increasing number of cataract procedures performed in the physician office setting. See
Part II, Item 7, “Management’s Discussion and Analysis-Results of Operations” for further discussion of OMIDRIA
reimbursement and pricing.
We have implemented a variety of programs and arrangements to facilitate the availability of OMIDRIA to cataract
and IOL replacement patients in the U.S., including the following:
•
•
•
various purchase volume-discount programs for OMIDRIA;
agreements to enable discounts on qualifying purchases of OMIDRIA by certain U.S. government purchasers
and other eligible entities, such as 340B-eligible hospitals and clinics; and
the OMIDRIAssure® Reimbursement Services Program, which we refer to as OMIDRIAssure.
OMIDRIAssure provides coverage and reimbursement support services for surgeons and facilities to help remove
uncertainties about coding, billing and coverage of OMIDRIA and to enable better access to the drug for patients facing
financial barriers. Under our “Equal Access” patient assistance program, financially eligible uninsured and government-
insured patients receive OMIDRIA free of charge for use during surgery. Through our “We Pay the Difference” program
we pay the facility, on behalf of commercially insured patients, the difference between the facility’s acquisition cost for
OMIDRIA, after accounting for any applicable volume discounts, and the amount covered by the patient’s insurance.
European Union and other International Territories. In July 2018, we placed OMIDRIA on the market in the EU on
a limited basis, which maintained the ongoing validity of the European marketing authorization for OMIDRIA.
Decisions about price and reimbursement for OMIDRIA are made on a country-by-country basis and may be required
before marketing may occur in a particular country. At this time we do not expect to see significant sales of OMIDRIA
in any countries within the EEA or other international territories if we are unable to complete a broad sales launch in any
such country either independently or through partnerships for the marketing and distribution of OMIDRIA. A marketing
authorization will cease to be valid if a product previously placed on the market is no longer actually present on the
market for three consecutive years. Timing of any partnerships or independent launch depends on numerous factors,
including domestic sales of OMIDRIA, completion of mutual diligence exercises and/or entry into suitable agreements
with contract service vendors.
2
Our Product Candidates and Development Programs
Our clinical product candidates consist of the following:
Product Candidate/Program
Targeted Disease(s)
Development Status
Next Expected
Milestone
Worldwide
Rights
Pivotal Trial
Complete
Complete BLA
and submit MAA
Omeros
(In-licensed)
Complete Phase
3 patient
enrollment or
perform 36-week
assessment of
proteinuria
Complete Phase
3 patient
enrollment
Determine
whether to
initiate Phase 3
program
Initiate Phase 2a
study
Further refine
development
path
Omeros
(In-licensed)
Omeros
(In-licensed)
Omeros
(In-licensed)
Omeros
(Compounds
In-licensed)
Omeros
Clinical
Narsoplimab
(OMS721/MASP-2) -
Lectin Pathway Disorders
Narsoplimab
(OMS721/MASP-2) -
Lectin Pathway Disorders
Hematopoietic Stem-Cell
Transplant-Associated
Thrombotic
Microangiopathy (HSCT-
TMA)
Immunoglobulin A
Nephropathy (IgAN)
Phase 3
Narsoplimab
(OMS721/MASP-2) -
Lectin Pathway Disorders
Narsoplimab
(OMS721/MASP-2) -
Lectin Pathway Disorders
Atypical Hemolytic Uremic
Phase 3
Syndrome (aHUS)
Lupus Nephritis and other
Phase 2
renal diseases
PDE7 (OMS527)
Addictions and compulsive
Phase 1
disorders; movement
disorders
PPARγ (OMS405) -
Addiction
Opioid and nicotine
Phase 2
addiction
3
Our pipeline of development programs consists of the following:
Product Candidate/Program
Preclinical / Platform
MASP-3 (OMS906) -
Alternative Pathway
Disorders
MASP-2 - Small-
Molecule Inhibitors
MASP-2 – Second
Generation Antibody
MASP-3 - Small-
Molecule Inhibitors
GPR174
GPCR Platform,
including GPR151,
GPR161, and other
Class A Orphan GPCRs
Antibody Platform
Targeted Disease(s)
Development Status
Next Expected
Milestone
Worldwide
Rights
Paroxysmal Nocturnal
Hemoglobinuria (PNH)
and other alternative
pathway disorders
aHUS, IgAN, HSCT-
TMA and Age-Related
Macular Degeneration
Long-acting second
generation antibody
targeting lectin pathway
disorders
PNH and other alternative
pathway disorders
Immuno-oncologic and
wide range of tumors
Immunologic,
Immuno-oncologic,
metabolic, CNS,
cardiovascular,
musculoskeletal & other
disorders
Metabolic,
cardiovascular,
oncologic,
musculoskeletal & other
disorders
Preclinical
Submit IND or
CTA
Omeros
Preclinical
Optimize
compounds
Preclinical
Preclinical
Preclinical
Preclinical
Preclinical
Process
development and
manufacturing
scale-up
Continue medicinal
chemistry and
advance co-
crystallization
efforts
Optimize
compounds
Continue drug
discovery and
selected medicinal
chemistry for
Class A Orphan
GPCRs
Continue
developing
antibodies targeting
lectin and
alternative pathway
of complement
system
Omeros
(In-licensed)
Omeros
Omeros
Omeros
Omeros
Omeros
(In-licensed)
MASP Inhibitor Clinical Programs
MASP-2 Program - Narsoplimab (OMS721) - Lectin Pathway Disorders
Overview. Mannan-binding lectin-associated serine protease-2 (“MASP-2”), is a novel pro-inflammatory protein
target involved in activation of the complement system, which is an important component of the immune system. The
complement system plays a role in the body’s inflammatory response and becomes activated as a result of tissue damage
or trauma or microbial pathogen invasion. Inappropriate or uncontrolled activation of the complement system can cause
diseases characterized by serious tissue injury. Three main pathways can activate the complement system: classical,
alternative and lectin. MASP-2 is recognized as the effector enzyme of the lectin pathway and is required for the
function of this pathway. Importantly, inhibition of MASP-2 has been demonstrated not to interfere with the antibody-
dependent classical complement activation pathway, a critical component of the acquired immune response to infection
the abnormal function of which is associated with a wide range of autoimmune disorders.
Our proprietary, patented lead human monoclonal antibody targeting MASP-2, which we have referred to as
OMS721, has been assigned the nonproprietary name narsoplimab. The current development focus for narsoplimab is
4
diseases in which the lectin pathway has been shown to contribute to significant tissue injury and pathology. When not
treated, these diseases are typically characterized by significant end organ injuries, such as kidney or central nervous
system injury. We have completed our pivotal clinical trial for narsoplimab in HSCT-TMA, and Phase 3 clinical
programs are in process for narsoplimab in IgA nephropathy and aHUS.
Thrombotic Microangiopathies
HSCT-TMA. In October 2019, we initiated the rolling submission to FDA of our BLA for narsoplimab for the
treatment of HSCT-TMA, a frequently lethal complication of HSCT. A rolling submission enables us to submit sections
of the BLA as they are completed, which can accelerate the time to approval by allowing FDA to review completed
sections of the application as they are submitted rather than waiting for the entire BLA to be submitted before beginning
its review. The initial submission to FDA included all of the nonclinical (i.e., pharmacology, pharmacokinetics and
toxicology) data, study reports, overview and summaries for the nonclinical sections of the BLA. We have also
successfully completed the manufacturing of the required process validation lots of narsoplimab. The clinical sections
and the chemistry, manufacturing and controls sections of the BLA are being prepared for submission and, once all data
collection and analysis are complete, these remaining parts of the BLA will be submitted.
On March 2, 2020, we reported clinical data from our pivotal trial of narsoplimab in HSCT-TMA. The single-arm,
open-label trial included safety and efficacy endpoints that were previously agreed to with FDA. These endpoints were
assessed for (1) all 28 patients who received at least one dose of narsoplimab and (2) patients who received the protocol-
specified dosing of at least four weeks of narsoplimab.
The primary efficacy endpoint in the trial was the proportion of patients who achieved designated “responder” status
based on improvement in HSCT-TMA laboratory markers and clinical status. This is referred to as the “complete
response rate.” The primary laboratory markers that were evaluated were platelet count and lactate dehydrogenase
(“LDH”), levels, while improvement in clinical status was evaluated based on organ function and transfusions. Patients
who did not fully meet these criteria were considered “non-responders.”
The FDA-agreed efficacy threshold for the primary endpoint is a complete response rate of 15 percent. Among
patients who received at least one dose of narsoplimab, the complete response rate was 54% (p<0.0001), while the
complete response rate among patients who received the protocol-specified narsoplimab treatment of at least four weeks
of dosing was 65% (p<0.0001).
Secondary endpoints in the trial were survival rates and change from baseline in HSCT-TMA laboratory markers.
Among the responder population, 93% of patients survived for at least 100 days following HSCT-TMA diagnosis, while
83% of patients who received treatment for at least four weeks and 68% of the total treated population achieved this
endpoint. Results also included statistically significant improvements in platelet count, LDH and haptoglobin. The
treated population had multiple high-risk features that portend a poor outcome, including the persistence of HSCT-TMA
despite modification of immunosuppression (which was a criterion for entry into the trial), graft-versus-host disease,
significant infections, non-infectious pulmonary complications and neurological findings. Patients in the trial had a high
expected mortality rate, with 93% of them having multiple risk factors. The most common adverse events observed in
the trial were nausea, vomiting, diarrhea, hypokalemia, neutropenia and fever, which are all common in stem-cell
transplant patients. Six deaths occurred during the trial. These were due to sepsis, progression of the underlying disease,
and graft-versus-host disease. All of these are common causes of death in this patient population.
In Europe, EMA has confirmed narsoplimab’s eligibility for EMA’s centralized review of a single MAA that, if
approved, authorizes the product to be marketed in all EU member states and EEA countries. We plan to complete the
submission of an MAA after our BLA submission has been filed with FDA. In October 2019 we received a positive
opinion from EMA on our pediatric investigation plan (“PIP”) for narsoplimab in the treatment of HSCT-TMA. A PIP
outlining a development program for the investigational product in the pediatric population must be agreed with EMA as
a prerequisite to EMA’s acceptance of an MAA. The narsoplimab PIP provides a study plan to evaluate the safety and
effectiveness of the drug for HSCT-TMA in patients from one month through 17 years of age. We received a deferral for
completion of our PIP until after approval of the narsoplimab MAA.
5
In the U.S., the FDA has granted narsoplimab (1) breakthrough therapy designation in patients who have persistent
TMA despite modification of immunosuppressive therapy, (2) orphan drug designation for the prevention (inhibition) of
complement-mediated TMAs, and (3) orphan drug designation for the treatment of HSCT-TMA. The EC also granted
narsoplimab designation as an orphan medicinal product for treatment in hematopoietic stem cell transplantation.
aHUS. We have an ongoing Phase 3 clinical program in patients with aHUS with active sites in the U.S., Europe
and Asia. The single-arm (i.e., no control arm), open-label Phase 3 clinical trial in patients with newly diagnosed or
ongoing aHUS is enrolling. This trial is targeting approximately 40 patients for EU approval and U.S. accelerated
approval with 80 patients required for full approval in the U.S. The trial includes multiple sites in the U.S., Asia and
Europe, and is actively enrolling, though enrollment has been slowed in part due to prioritizing the use of resources
within our narsoplimab programs on HSCT-TMA and IgA nephropathy. Dosing consists of an initial IV loading
followed by daily subcutaneous dosing. Based on discussions with the FDA and the EMA, we expect that the clinical
package for the BLA would be similar to that which formed the basis of approval for Soliris® (eculizumab), which is
marketed by Alexion Pharmaceuticals, Inc.
The FDA has granted to narsoplimab orphan drug designation for the prevention (inhibition) of complement-
mediated TMAs and fast-track designation for the treatment of patients with aHUS.
Renal Disease
Phase 2 Clinical Trial - Renal Diseases. We have been conducting a Phase 2 clinical trial in patients with
complement-associated renal diseases, specifically designed to cover: (1) IgA nephropathy; (2) membranous
nephropathy; and (3) lupus nephritis. An initial open-label cohort of patients completed treatment in May 2017.
All patients in the initial open-label cohort of the trial were required to have high levels of urinary protein, or
proteinuria (a marker used by nephrologists to assess disease activity), despite ongoing treatment with corticosteroids.
These inclusion criteria were intended to ensure that study patients are unlikely to improve spontaneously. Patients in
this open-label cohort were treated with narsoplimab for a total of 12 weeks: four weeks maintaining their entry
corticosteroid dose; four weeks of corticosteroid tapering, if tolerated; and four weeks of resultant corticosteroid dose
maintenance or discontinuation. Patients were then followed post-treatment for six weeks.
All four patients with IgA nephropathy in the initial open-label cohort demonstrated clinically meaningful and
statistically significant improvement in proteinuria during the 18-week trial period. Follow-up data collected after
patients completed treatment in the trial period showed that three of the four IgA nephropathy patients in this cohort
maintained the proteinuria reduction (as measured by urine albumin/creatinine ratio) shown in the clinical trial during
the follow-up period (assessed at 12, 11 and three months, respectively, after cessation of dosing). Numerical
improvement in estimated glomerular filtration rate (“eGFR”), a measure of renal function, was also observed in three of
the four patients after the trial. Narsoplimab was well-tolerated in the clinical trial with fatigue and anemia being the
most commonly reported adverse events.
In the second cohort evaluating patients with IgA nephropathy in the U.S., patients must have elevated levels of
urinary protein but are not treated with corticosteroids. Patients in this cohort were treated for 12 weeks with weekly
dosing of either narsoplimab or placebo, then followed for six weeks with no treatment. After week 18, patients initially
treated with placebo and patients initially treated with narsoplimab were able to receive additional 12-week courses of
open-label dosing with narsoplimab at investigator discretion. Patients may receive more than one 12-week course of
narsoplimab and will be followed for a total of two years.
In October 2018, we reported interim results from the second cohort of IgA nephropathy patients in the U.S. Unlike
the first open-label cohort comprised of four IgA nephropathy patients who were taking corticosteroids at the time of
study enrollment, patients in the second cohort were not taking steroids. The cohort included nine evaluable patients. At
week 18, median reduction in proteinuria was 18.4% in the five narsoplimab-treated patients and 18.0% in the four
placebo patients. This study did not include a run-in period during which time renin-angiotensin system (“RAS”),
blockade is optimized and patient compliance with RAS blockade is improved. The placebo response in this first
18-week period is consistent with improvement in placebo groups seen during the run-in periods of other studies in IgA
6
nephropathy patients. After week 18, eight of the nine evaluable patients entered the extended dosing and observation
period, all of whom received narsoplimab treatment during this period. At the last observation point for each the eight
patients (between 31 and 54 weeks post-baseline) the median reduction from baseline proteinuria was 61%. Five of the
eight patients have achieved greater than 50% proteinuria reductions (median reduction of 65%), with two of those five
patients having received their last narsoplimab administration five months earlier. Measurement of eGFR have also
remained stable, consistent with preservation of renal function. Despite the small cohort of patients, and although median
reductions in proteinuria in the placebo group were comparable to those in the narsoplimab group following the initial
12-week course of treatment, we and international experts in IgA nephropathy with whom we have consulted and who
have reviewed the individual patient data believe that these data are positive and supportive of a substantial disease
modifying effect. With proteinuria reduction in five of eight patients ranging from greater than 50% to approximately
70%, this magnitude is consistent with what we previously reported from the first cohort of this clinical trial. This trial
also includes a third cohort of patients with all study sites for this cohort located in Hong Kong. This is a small study,
slated to enroll approximately 10 patients, all Asians. It has been redesigned to focus on subcutaneous dosing and
associated biomarkers. Given demonstrated activity with subcutaneous dosing, we will continue to determine the
pharmacokinetics and pharmacodynamics of narsoplimab in IgA nephropathy patients when administered
subcutaneously over a 12-week period. Enrollment in this study began in September 2019, though enrollment is
currently suspended due to restrictions imposed at the site in connection with the COVID-19 coronavirus. Data from this
cohort will support the ongoing Phase 3 program in IgA nephropathy and planned lifecycle management for
narsoplimab.
We have also reported encouraging results in lupus nephritis patients from the first cohort in the Phase 2 renal
disease trial. We are considering possible further development in lupus nephritis.
Phase 3 Program - IgA Nephropathy. Patient enrollment is ongoing in our Phase 3 clinical trial evaluating
narsoplimab, which is referred to as ARTEMIS-IGAN. The single Phase 3 trial design is a randomized, double-blind,
placebo-controlled multicenter trial in patients at least 18 years of age with biopsy-confirmed IgA nephropathy and with
24-hour urine protein excretion greater than 1 g/day at baseline on optimized RAS blockade. This trial includes a run-in
period. Initially, patients are expected to receive an IV dose of study drug each week for 12 weeks; additional weekly
dosing can be administered to achieve optimal response. The primary endpoint, which could suffice for full or
accelerated approval depending on the effect size, is reduction in proteinuria at 36 weeks after the start of dosing. The
trial is designed to allow intra-trial adjustment in sample size. For the purposes of safety and efficacy assessments, the
initial sample size for the proteinuria endpoint is estimated at 140 patients in each of the treatment and placebo groups.
This will include a subset of patients with high levels of proteinuria (i.e., equal to or greater than 2 g/day) at baseline,
and a substantial improvement at 36 weeks in this subset of patients alone could potentially form the basis for approval.
We believe that the trial design will allow assessment for either full or accelerated approval at 36 weeks based on
proteinuria results either (1) across the general population of study patients or (2) in the high-proteinuria subset of
patients. In the event of full approval, eGFR becomes a safety endpoint only. In the event that the primary endpoint at
36 weeks results in accelerated approval from the FDA, change in eGFR is expected to be assessed at approximately
three years after the start of dosing. These eGFR data, if satisfactory, would then likely form the basis for full approval.
In response to investigators’ concerns about extended withholding of narsoplimab treatment from any high-proteinuria
patient initially randomized to the placebo-treated group, the FDA will allow patients in that sub-population open-label
treatment with narsoplimab after at least 1 year of blinded treatment.
In the U.S., narsoplimab has received breakthrough therapy and orphan drug designations from the FDA for the
treatment of IgA nephropathy. In Europe narsoplimab has received orphan drug designation from the EC in patients with
IgA nephropathy.
Expanded Access / Compassionate Use. We have received requests from investigators and other physicians for
expanded access to narsoplimab. Expanded access, sometimes called “compassionate use,” is the use of an
investigational medical product outside of a clinical trial. Expanded access is permitted by the FDA and other regulatory
agencies under specific circumstances. Narsoplimab has been provided to several patients in compassionate use
situations. In December 2019, we announced a collaboration with myTomorrows, a health technology company, to
broaden our expanded access program for narsoplimab.
7
Licensing Arrangements. We hold worldwide exclusive licenses to rights related to MASP-2, the antibodies
targeting MASP-2 and the therapeutic applications for those antibodies from the University of Leicester, from its
collaborator, the Medical Research Council at Oxford University (“MRC”), and from Helion Biotech ApS (“Helion”).
For a more detailed description of these licenses, see “License and Development Agreements” below.
MASP Inhibitor Preclinical Programs
MASP-3 Program - OMS906 - Alternative Pathway Disorders
Overview. As part of our MASP program, we have identified mannan-binding lectin-associated serine protease-3
(“MASP-3”), which has been shown to be the key activator of the complement system’s alternative pathway (“APC”),
and we believe that we are the first to make this and related discoveries associated with the APC. The complement
system is part of the immune system’s innate response, and the APC is considered the amplification loop within the
complement system. MASP-3 is responsible for the conversion of pro-factor D to factor D; converted factor D is
necessary for the activation of the APC. Based on our alternative pathway-related discoveries, we have expanded our
intellectual property position to protect our inventions stemming from these discoveries beyond MASP-2-associated
inhibition of the lectin pathway to include inhibition of the alternative pathway.
Our current primary focus in this program is developing MASP-3 inhibitors for the treatment of disorders related to
the APC. We believe that MASP-3 inhibitors have the potential to treat patients suffering from a wide range of diseases
and conditions, including: paroxysmal nocturnal hemoglobinuria (“PNH”); C3 glomerulopathy; multiple sclerosis;
arthritis; traumatic brain injury; neuromyelitis optica; pauci-immune necrotizing crescentic glomerulonephritis;
disseminated intravascular coagulation; age-related macular degeneration; asthma; dense deposit disease; Bechet’s
disease; aspiration pneumonia; TMA; ischemia-reperfusion injury; Guillain Barre syndrome; Alzheimer’s disease;
amylotrophic lateral sclerosis; systemic lupus erythematosus; diabetic retinopathy; uveitis; chronic obstructive
pulmonary disease; transplant rejection; acute respiratory distress syndrome; antineutrophil cytoplasmic antibody-
associated vasculitis; anti-phospholipid syndrome; atherosclerosis; myasthenia gravis and others.
Our OMS906 program has generated positive data in a well-established animal model associated with PNH
including in non-human primates. The program has also generated positive data in a well-established model of arthritis.
In preparation for clinical trials, the manufacturing scale-up process is underway for a MASP-3 inhibitor antibody and
we are currently targeting PNH as the first clinical indication for OMS906. Clinical trials are slated to begin in the first
half of 2020.
Licensing Arrangements. We jointly own and hold worldwide exclusive license rights related to therapeutic
applications for inhibiting MASP-3 from the University of Leicester. For a more detailed description of these licenses,
see “License and Development Agreements” below.
Other MASP Inhibitor Preclinical Programs
We have generated positive preclinical data from MASP-2 inhibition in in vivo models of AMD, myocardial
infarction, diabetic neuropathy, stroke, ischemia-reperfusion injury, and other diseases and disorders.
We are also developing a longer-acting second generation antibody targeting MASP-2, which we are targeting for
initiation of clinical trials in 2022. Development efforts are also directed to a small-molecule inhibitor of MASP-2
designed for oral administration, as well as small-molecule inhibitors of MASP-3 and bispecific small- and large-
molecule inhibitors of MASP-2/-3.
Other Clinical Programs
PDE7 Program - OMS527
Overview. Our phosphodiesterase 7 (“PDE7”) program is based on our discoveries of previously unknown links
between PDE7 and any addiction or compulsive disorder, and between PDE7 and any movement disorders, such as
8
Parkinson’s disease. PDE7 appears to modulate the dopaminergic system, which plays a significant role in regulating
both addiction and movement. We believe that PDE7 inhibitors could be effective therapeutics for the treatment of
addictions and compulsions as well as for movement disorders. Data generated in preclinical studies support the use of
PDE7 inhibitors in both of these therapeutic areas.
In September 2019, we reported positive results from our completed Phase 1 clinical trial designed to assess the
safety, tolerability and pharmacokinetics of the compound in healthy subjects. In the double blind, randomized Phase 1
study, the study drug, referred to as OMS182399, met the primary endpoints of safety and tolerability and showed a
favorable and dose-proportional pharmacokinetic profile supporting once-daily dosing. There was no apparent food
effect on plasma exposure to OMS182399. Our focus is nicotine addiction, and we are planning our Phase 2
development program.
Exclusive License Agreement with Daiichi Sankyo Co., Ltd. We hold an exclusive license to certain PDE7 inhibitors
claimed in patents and pending patent applications owned by Daiichi Sankyo Co., Ltd. (“Daiichi Sankyo”), as successor-
in-interest to Asubio Pharma Co., Ltd., or, for use in the treatment of movement, addiction and compulsive disorders as
well as other specified indications. For a more detailed description of our agreement with Daiichi Sankyo, see “License
and Development Agreements” below.
PPARγ Program - OMS405
Overview. In our peroxisome proliferator-activated receptor gamma (“PPARγ”) program, we have engaged in
development of proprietary compositions that include PPARγ agonists for the treatment and prevention of addiction to
substances of abuse, which may include opioids, nicotine and alcohol. We believe that Omeros is the first to demonstrate
a link between PPARγ and addiction disorders. Data from clinical studies and from animal models of addiction suggest
that PPARγ agonists could be efficacious in the treatment of a wide range of addictions.
Clinical trials. Our collaborators at The New York State Psychiatric Institute have completed two Phase 2 clinical
trials related to our PPARγ program. These studies evaluated a PPARγ agonist, alone or in combination with other
agents, for treatment of addiction to heroin and to nicotine. The published results of the heroin study demonstrated that,
although not altering the reinforcing or positive subjective effects of heroin, the PPARγ agonist significantly reduced
heroin craving and overall anxiety. The National Institute on Drug Abuse provided substantially all of the funding for
these clinical trials and solely oversaw the conduct of these trials. We have the right or expect to be able to reference the
data obtained from these studies for subsequent submissions to the FDA and continue to retain all other rights in
connection with the PPARγ program. We have also reported positive results (i.e., decreased cravings and protection of
brain white matter) from a Phase 2 clinical trial conducted by an independent investigator evaluating the effects of a
PPARγ agonist in patients with cocaine use disorder.
Patent Assignment Agreement with Roberto Ciccocioppo, Ph.D. We acquired the patent applications and related
intellectual property rights for our PPARγ program in February 2009 from Roberto Ciccocioppo, Ph.D., of the
Università di Camerino, Italy, pursuant to a patent assignment agreement. For a more detailed description of our
agreement with Dr. Ciccocioppo, see “License and Development Agreements” below.
Preclinical Programs and Platforms
GPCR Platform
Overview. GPCRs, which are cell surface membrane proteins involved in mediating both sensory and nonsensory
functions, comprise one of the largest families of proteins in the genomes of multicellular organisms. Sensory GPCRs
are involved in the perception of light, odors, taste and sexual attractants. Non-sensory GPCRs are involved in
metabolism, behavior, reproduction, development, hormonal homeostasis and regulation of the central nervous system.
The vast majority of GPCR drug targets are non-sensory. Although GPCRs form a super-family of receptors, individual
GPCRs display a high degree of specificity and affinity for the functionally active molecules, or ligands, that bind to a
given receptor. Ligands can either activate the receptor (agonists) or inhibit it (antagonists and inverse agonists). When
activated by its ligand, the GPCR interacts with intracellular G proteins, resulting in a cascade of signaling events inside
9
the cell that ultimately leads to the particular function linked to the receptor. Without a known ligand, there is no
template from which medicinal chemistry efforts can be readily initiated, nor a means to identify the GPCR’s signaling
pathway and, therefore, drugs are very difficult to develop against orphan GPCRs. “Unlocking” these orphan GPCRs by
identifying one or more of their respective ligands could lead to the development of drugs that act at these new targets.
To our knowledge, Omeros’ technology is the first commercially viable technology capable of identifying ligands of
orphan GPCRs in high throughput. We have developed a proprietary cellular redistribution assay (“CRA”), which we
use in a high-throughput manner to identify synthetic ligands, including antagonists, agonists and inverse agonists, that
bind to and affect the function of orphan GPCRs. We have screened Class A orphan GPCRs against our small-molecule
chemical libraries using the CRA. As of December 31, 2019, we had identified and confirmed compounds that interact
with 54 of the 81 Class A orphan GPCRs linked to a wide range of indications including cancer as well as metabolic,
cardiovascular, immunologic, inflammatory and central nervous system disorders.
One of our priorities in this program is GPR174, which is involved in the modulation of the immune system. In ex
vivo human studies, our small-molecule inhibitors targeting GPR174 upregulate the production of cytokines, block
multiple checkpoints and tumor promoters, and suppress regulatory T-cells. Based on our data, we believe that GPR174
controls a major pathway in cancer and modulation of the receptor could provide a seminal advance in immuno-
oncologic treatments for a wide range of tumors. Our recent discoveries suggest a new approach to cancer
immunotherapy that targets inhibition of GPR174 and can be combined with and significantly improve the tumor-killing
effects of adenosine pathway inhibitors. These discoveries include (1) identification of cancer-immunity pathways
controlled by GPR174, (2) the identification of phosphatidylserine as a natural ligand for GPR174, (3) a collection of
novel small-molecule inhibitors of GPR174 and (4) a synergistic enhancement of “tumor-fighting” cytokine production
by T cells following the combined inhibition of both GPR174 and the adenosine pathway, another key metabolic
pathway that regulates tumor immunity. In November 2019, we announced that our studies in mouse models of
melanoma and colon carcinoma found that GPR174-deficiency resulted in significantly reduced tumor growth and
improved survival of the animals versus normal mice. We continue to focus on GPR174 and several other of our GPCR
targets with the objective of moving compounds targeting them into human trials.
We have also conducted in vitro and in vivo preclinical efficacy studies and engaged in compound optimization for a
number of targets including GPR151, which is linked to schizophrenia, cognition and obesity, and GPR161, which is
associated with triple negative breast cancer and various sarcomas.
In addition to Class A orphan GPCRs, we have screened orphan and non-orphan Class B receptors. Class B GPCRs
have large extracellular domains and their natural ligands are generally large peptides, making the development of orally
active, small-molecule drugs against these receptors, such as glucagon and parathyroid hormone, a persistent challenge.
Our CRA technology finds functionally active small molecules for GPCRs, which we believe could lead to the
development of oral medications for many of the Class B GPCRs. While our focus to date has remained on Class A
orphan GPCRs, we have identified and confirmed sets of compounds that interact selectively with, and modulate
signaling of, a small subset of Class B GPCRs, namely glucagon-like peptide-1 receptor and parathyroid hormone 1
receptor.
GPCR Platform Funding Agreements with Vulcan Inc. and the Life Sciences Discovery Fund. In October 2010, we
entered into funding agreements for our GPCR program with Vulcan Inc. and its affiliate, which we refer to collectively
as Vulcan, and with the Life Sciences Discovery Fund Authority (“LSDF”), a granting agency of the State of
Washington. For a more detailed description of these agreements, see “License and Development Agreements” below.
Antibody Platform
Overview. Our proprietary ex vivo platform for the discovery of novel, high-affinity monoclonal antibodies, which
was in-licensed from the University of Washington (“UW”) and then further developed by our scientists, utilizes a
chicken B-cell lymphoma cell line. It has successfully generated diverse antibodies that can be readily engineered. We
believe this platform offers several advantages over other antibody platforms. The ex vivo immunizations of our
proprietary cell line are significantly more rapid than whole animal immunizations and conventional hybridoma
technology. By avoiding immunization of mice or other animals, we believe the antibodies we generate from this
10
platform are not limited by immunological tolerance. In addition, our platform is capable of producing novel antibodies
against difficult targets, such as highly homologous proteins, enzymes, and receptors with short extracellular domains.
Chicken antibodies also have unique features that enable binding capabilities distinct from mammalian antibodies.
Using our platform and other know-how and techniques, we have generated antibodies to several clinically
significant targets, including highly potent antibodies against MASP-2, MASP-3 and MASP-1, and we continue to add
to our pipeline antibodies against additional important targets.
Asset Purchase Agreement with Xori Corporation. In February 2012 we entered into an asset purchase agreement
with Xori Corporation (“Xori”), pursuant to which we acquired all of Xori’s rights and obligations in certain license and
material transfer agreements, intellectual property, antibodies and other assets related to our antibody platform. We are
obligated to make development and research-related milestone payments to Xori.
Exclusive License Agreement with the University of Washington. We hold a worldwide exclusive license to patent
rights related to our antibody platform from the University of Washington. For a more detailed description of this
agreement, see “License and Development Agreements” below.
Sales and Marketing
We have retained all worldwide marketing and distribution rights to OMIDRIA, our product candidates and our
development programs. This allows us to market and sell OMIDRIA and any product candidates that is approved in the
future, either independently, through arrangements with third parties, or via some combination of these approaches.
With respect to OMIDRIA in the U.S., we have developed our own internal marketing and sales capabilities and, as
of December 31, 2019, we employed 64 sales and reimbursement team members. In July 2018 we placed OMIDRIA on
the market in the EU on a limited basis, which maintained the ongoing validity of the European marketing authorization
for OMIDRIA. Our European marketing authorization will cease to be valid if a product previously placed on the market
is no longer actually present on the market for three consecutive years. Other than an agreement with a third party for
sale and distribution of OMIDRIA in certain countries in the Middle East, which has not generated significant sales, we
have not yet entered into any agreements with third parties to market OMIDRIA outside of the U.S.
Manufacturing, Supply and Commercial Operations
OMIDRIA. We use third parties to produce, store and distribute OMIDRIA and currently do not own or operate
manufacturing facilities. Our agreements with these third parties include confidentiality and intellectual property
provisions to protect our proprietary rights related to OMIDRIA. We require manufacturers that produce APIs and
finished drug products to operate in accordance with current Good Manufacturing Practices (“cGMPs”) and all other
applicable laws and regulations.
We have an agreement with Hospira Worldwide, Inc. (“Hospira”), a wholly owned subsidiary of Pfizer, Inc., to
provide commercial supply of OMIDRIA. Under the agreement with Hospira (the “Hospira OMIDRIA Agreement”),
Hospira has agreed to manufacture and supply, and we have agreed to purchase, a minimum percentage of our
requirements of OMIDRIA for commercial sales and clinical supplies for the development of additional therapeutic
indications in the U.S. In addition, Hospira has agreed to manufacture and supply a portion of our requirements of
OMIDRIA in the EU, with there being no minimum purchase and supply requirement in the EU if the parties do not
enter into such an amendment to the agreement. We have not yet entered into such an agreement with Hospira relating to
the supply of OMIDRIA for the EU. The Hospira OMIDRIA Agreement expires in February 2022, but may be
terminated prior to the end of its term upon the occurrence of certain specified events, including without limitation an
uncured breach of the agreement or bankruptcy or dissolution of a party. Upon termination of the Hospira OMIDRIA
Agreement, except in the case of termination for an uncured breach by Hospira, we will be required to purchase all of
Hospira’s inventory of OMIDRIA and, if applicable, all work-in-progress inventory and to reimburse Hospira for all
supplies purchased or ordered based on firm purchase orders or our estimates of its requirements of OMIDRIA.
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We have used multiple suppliers for the APIs for OMIDRIA in the past and we intend to leverage Hospira’s
sourcing of APIs in the future under the Hospira OMIDRIA Agreement. Given the large amount of these APIs
manufactured annually by these and other suppliers, and the quantities of these APIs that we have on hand, we anticipate
that we will be capable of addressing our commercial API supply needs for OMIDRIA in the near-term. We have not yet
signed commercial agreements with suppliers for the supply of all of our anticipated commercial quantities of these APIs
for OMIDRIA, although we may elect to do so in the future. In addition to our supply agreement with Hospira, we have
executed an agreement with a second manufacturing partner for supply of OMIDRIA. Work to bring the second
manufacturer online is ongoing and we anticipate OMIDRIA to be available from this manufacturer beginning in 2021.
In the U.S., we sell OMIDRIA through a limited number of wholesalers that distribute the product to ASCs and
hospitals. Title transfers upon delivery of OMIDRIA to the wholesaler. We use a single third-party logistics provider to
handle warehousing and final packaging of our commercial supply of OMIDRIA in the U.S. and to ship OMIDRIA to
our wholesalers. Our third-party logistics provider also performs certain support services on our behalf. Virtually all of
our revenues for the last three fiscal years were generated from OMIDRIA product sales in the U.S. Our four major
distributors--AmerisourceBergen Corporation, Cardinal Health, Inc., McKesson Corporation and FFF Enterprises, Inc.--
together with entities under their common control each accounted for 10% or more, and nearly 100% in aggregate, of our
total revenue in 2019. For additional information regarding our major customers, see Part II, Item 8, “Note 2--Significant
Accounting Policies” to our Consolidated Financial Statements in this Annual Report on Form 10 K
Product Candidates. We have laboratories in-house for analytical method development, bioanalytical testing,
formulation, stability testing and small-scale compounding of laboratory supplies of product candidates. We utilize
contract manufacturers to produce sufficient quantities of product candidates for use in preclinical and clinical studies
and to store and distribute our product candidates. We require manufacturers that produce APIs and finished drug
products for clinical use to operate in accordance with cGMPs and all other applicable laws and regulations. We
anticipate that we will rely on contract manufacturers to develop and manufacture our product candidates for commercial
sale. We maintain agreements with potential and existing manufacturers that include confidentiality and intellectual
property provisions to protect our proprietary rights related to our product candidates.
In July 2019, we entered into a master services agreement with Lonza Biologics Tuas Pte. Ltd. (“Lonza”) for the
commercial production of narsoplimab and for certain regulatory support and related services to be provided by Lonza
from time to time. Under the agreement Lonza will manufacture narsoplimab pursuant to purchase orders issued in
accordance with forecasts that we provide. We will purchase narsoplimab that meets agreed specifications in batches,
with the price per batch varying according to the total number of batches ordered for serial production in a single
manufacturing campaign. We are obligated to purchase a minimum number of batches annually beginning on a specified
anniversary of the first commercial sale of narsoplimab in either the U.S. or EU. We may be obligated to pay certain fees
to Lonza upon cancellation of purchase orders.
The initial term of the agreement expires five years after the first commercial sale of narsoplimab in either the U.S.
or EU, and is subject to automatic renewal for an additional four-year term unless we provide notice of non-renewal at
least three years prior to the end of the initial term. In addition, either party may terminate the agreement, subject to
applicable notice and cure periods under certain circumstances. Other than our agreement for commercial supply of
narsoplimab, we have not yet entered into a commercial supply agreement for any of our product candidates.
License and Development Agreements
MASP Program. Under our exclusive license agreements with the University of Leicester and MRC, we have agreed
to pay royalties to each of the University of Leicester and MRC that are a percentage of any proceeds we receive from
the licensed MASP-2 technology during the terms of the agreements. Our exclusive license agreement with the
University of Leicester, but not our agreement with the MRC, also applies to other MASPs. The continued maintenance
of these agreements requires us to undertake development activities. We must pay low single-digit percentage royalties
with respect to proceeds that we receive from products incorporating certain intellectual property within the licensed
technology that are used, manufactured, directly sold or directly distributed by us, and we must pay royalties, in the
range of a low single-digit percentage to a low double-digit percentage, with respect to proceeds we receive from
sublicense royalties or fees that we receive from third parties to which we grant sublicenses to certain intellectual
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property within the licensed technology. We did not make any upfront payments for these exclusive licenses nor are
there any milestone payments or reversion rights associated with these license agreements. We retain worldwide
exclusive licenses from these institutions to develop and commercialize any intellectual property rights developed in the
sponsored research. The term of each license agreement ends when there are no longer any pending patent applications,
applications in preparation or unexpired issued patents related to any of the intellectual property rights we are licensing
under the agreement. Both of these license agreements may be terminated prior to the end of their terms by us for
convenience or by one party if the other party (1) breaches any material obligation under the agreement and does not
cure such breach after notice and an opportunity to cure or (2) is declared or adjudged to be insolvent, bankrupt or in
receivership and materially limited from performing its obligations under the agreement.
In April 2010, we entered into an exclusive license agreement with Helion, pursuant to which we received a royalty-
bearing, worldwide exclusive license to all of Helion’s intellectual property rights related to MASP-2 antibodies,
polypeptides and methods in the field of inhibition of mannan-binding lectin-mediated activation of the complement
system for the prevention, treatment or diagnosis of any disease or condition. We are obligated to make remaining
development and sales milestone payments to Helion of up to approximately $5.4 million upon the achievement of
certain events, such as receipt of marketing approval, and reaching specified sales milestones. We are obligated to pay
Helion a low single-digit percentage royalty on net sales of a MASP-2 inhibitor product covered by the patents licensed
under the agreement. The term of the agreement continues so long as there is a valid, subsisting and enforceable claim in
any patents or patent applications covered by the agreement. The agreement may be terminated sooner by either party
following a material breach of the agreement by the other party that has not been cured within 90 days.
PPARγ. We acquired the patent applications and related intellectual property rights for our PPARγ program in
February 2009 from Roberto Ciccocioppo, Ph.D. of the Università di Camerino, Italy, pursuant to a patent assignment
agreement. In February 2011, we amended the agreement to include all intellectual property rights, including patent
applications, related to nutraceuticals that increase PPARγ activity. Under the amended agreement, we have agreed to
pay Dr. Ciccocioppo a low-single digit percentage royalty on net sales of any products that are covered by any patents
that issue from the patent applications that we acquired from him. In addition, if we grant any third parties rights to
manufacture, sell or distribute any such products, we must pay to Dr. Ciccocioppo a percentage of any associated fees
we receive from such third parties in the range of low single-digits to low double-digits depending on the stage of
development at which such rights are granted. We have also agreed to make total milestone payments of up to
$3.8 million to Dr. Ciccocioppo upon the occurrence of certain development events, such as patient enrollment in a
Phase 1 clinical trial and receipt of marketing approval of a product candidate covered by any patents that issue from the
patent applications that we acquired from him. If we notify Dr. Ciccocioppo that we have abandoned all research and
development and commercialization efforts related to the patent applications and intellectual property rights we acquired
from him, Dr. Ciccocioppo has the right to repurchase those assets from us at a price equal to a double-digit percentage
of our direct and indirect financial investments and expenditures in such assets. If he does not exercise his right to
repurchase those assets within a limited period of time by paying the purchase price, we will have no further obligations
to sell those assets to Dr. Ciccocioppo. The term of our agreement with Dr. Ciccocioppo ends when there are no longer
any valid and enforceable patents related to the intellectual property rights we acquired from him, provided that either
party may terminate the agreement earlier in case of an uncured breach by the other party. Under the terms of the
agreement, we have agreed to pay a portion of the payments due to Dr. Ciccocioppo to the Università di Camerino
without any increase to our payment obligations.
PDE7. Under an agreement with Daiichi Sankyo, we hold an exclusive worldwide license to PDE7 inhibitors
claimed in certain patents and pending patent applications owned by Daiichi Sankyo for use in the treatment of
(1) movement disorders and other specified indications, (2) addiction and compulsive disorders and (3) all other diseases
except those related to dermatologic conditions. Under the agreement, we agreed to make milestone payments to Daiichi
Sankyo of up to an aggregate total of $33.5 million upon the achievement of certain events in each of these three fields;
however, if only one of the three indications is advanced through the milestones, the total milestone payments would be
$23.5 million. The milestone payment events include successful completion of preclinical toxicology studies; dosing of
human subjects in Phase 1, 2 and 3 clinical trials; receipt of marketing approval of a PDE7 inhibitor product candidate;
and reaching specified sales milestones. In addition, Daiichi Sankyo is entitled to receive from us a low single-
digit percentage royalty of any net sales of a PDE7 inhibitor licensed under the agreement by us and/or our
sublicensee(s) provided that, if the sales are made by a sublicensee, then the amount payable by us to Daiichi Sankyo is
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capped at an amount equal to a low double-digit percentage of all royalty and specified milestone payments received by
us from the sublicensee.
The term of the agreement with Daiichi Sankyo continues so long as there is a valid, subsisting and enforceable
claim in any patents covered by the agreement. The agreement may be terminated sooner by us, with or without cause,
upon 90 days advance written notice or by either party following a material breach of the agreement by the other party
that has not been cured within 90 days or immediately if the other party is insolvent or bankrupt. Daiichi Sankyo also has
the right to terminate the agreement if we and our sublicensee(s) cease to conduct all research, development and/or
commercialization activities for a PDE7 inhibitor covered by the agreement for a period of six consecutive months, in
which case all rights held by us under Daiichi Sankyo’s patents will revert to Daiichi Sankyo.
GPCR Platform Funding Agreements with Vulcan Inc. and the Life Sciences Discovery Fund. In October 2010, we
entered into funding agreements for our GPCR program with Vulcan and LSDF. We received $20.0 million and
$5.0 million, respectively, under the agreements with Vulcan and LSDF. Under these agreements, we have agreed to pay
Vulcan and LSDF tiered percentages of the net proceeds, if any, that we derive from the GPCR program. The percentage
rates of net proceeds payable to Vulcan and LSDF decrease as the cumulative net proceeds reach specified thresholds,
and the blended percentage rate payable to Vulcan and LSDF in the aggregate is in the mid-teens with respect to the first
approximately $1.5 billion of cumulative net proceeds that we receive from our GPCR program. If we receive
cumulative net proceeds in excess of approximately $1.5 billion, the percentage rate payable to Vulcan and LSDF in the
aggregate decreases to one percent. An acquirer of the assets in our GPCR program may be required, and an acquirer of
our company would be required, to assume all of our payment and other obligations under our agreements with Vulcan
and LSDF.
Under our agreement with Vulcan, we granted Vulcan a security interest in our personal property related to the
GPCR program, other than intellectual property, which security interest is junior to any existing or future security
interests granted in connection with a financing transaction and which will be released automatically after Vulcan
receives $25.0 million under the agreement. We also agreed not to grant any liens on intellectual property related to the
GPCR program without Vulcan’s consent, subject to specified exceptions. These restrictions could limit our ability to
pursue business opportunities involving the GPCR program or reduce the price that a potential buyer would pay for the
GPCR assets. If we default under our agreement with Vulcan, in certain circumstances Vulcan may, subject to the rights
of any holders of senior security interests, take control of such pledged assets. If we are liquidated, Vulcan’s right to
receive any payments then due under our agreement would be senior to the rights of the holders of our common stock to
receive any proceeds from the liquidation of our GPCR program assets.
The term of our agreement with Vulcan is 35 years, provided that the term will automatically extend until the
cumulative net proceeds that we receive from the GPCR program are approximately $1.5 billion. The term of our
agreement with LSDF expires on the six-month anniversary following the last date that we deliver a report related to our
incurrence of grant-funded expenses described in the agreement, provided that certain obligations will survive the
expiration of the term. The term of our payment obligations to LSDF is the same as that under our agreement with
Vulcan.
Antibody Platform. We hold a worldwide exclusive license to patent rights related to our antibody platform from the
University of Washington. Pursuant to our asset purchase agreement with Xori, we acquired all of Xori’s exclusive
rights under a license agreement with the UW to certain patents and patent applications related to our antibody platform
owned by the UW in exchange for our agreement to make royalty and development milestone payments to UW.
OMIDRIA. We entered into settlement agreements and consent judgments with (1) Par Pharmaceutical, Inc. and its
subsidiary, Par Sterile Products, LLC (collectively, “Par”) and (2) Lupin Ltd. and Lupin Pharmaceuticals, Inc.
(collectively, “Lupin”) in October 2017 and May 2018, respectively.
Under the terms of the settlement agreements and consent judgments, Par and Lupin are each prohibited from
launching a generic version of OMIDRIA prior to a specified entry date. Par’s entry date is the earlier of (1) April 1,
2032 or (2) the date on which we or a third-party, through licensing or any future final legal judgment, should one ever
exist, with respect to our Orange Book listed patents, is able to launch a generic version of OMIDRIA. Lupin’s entry
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date is the earlier of (A) April 1, 2032 if Par has forfeited its six month first-ANDA filer exclusivity, (B) October 1, 2032
if Par has not forfeited its six month first-ANDA filer exclusivity, or (C) a date on which we or a third party (other than
Par), through licensing of, any future final legal judgment regarding, or the delisting, abandonment or expiration of our
U.S. OMIDRIA patents, is able to launch a generic version of OMIDRIA. Under the settlement agreements, we granted
each of Par and Lupin a non-exclusive, non-sublicensable license to make, sell and distribute a generic version of
OMIDRIA between their applicable entry dates and the latest expiration of our U.S. patents related to OMIDRIA (i.e.,
October 23, 2033). During this period, Par and Lupin, as applicable, are each required to pay us a royalty equal to 15%
of net sales of its generic version of OMIDRIA.
Competition
Overview. The pharmaceutical industry is highly competitive and characterized by a number of established, large
pharmaceutical companies as well as smaller companies like ours. We expect to compete with other pharmaceutical and
biotechnology companies, and our competitors may:
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develop and market products that are less expensive, more effective or safer than our future products;
commercialize competing products before we can launch our products;
operate larger research and development programs, possess greater manufacturing capabilities or have
substantially greater financial resources than we do;
initiate or withstand substantial price competition more successfully than we can;
have greater success in recruiting skilled technical and scientific workers from the limited pool of available
talent;
• more effectively negotiate third-party licenses and strategic relationships; and
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take advantage of acquisition or other opportunities more readily than we can.
We expect to compete for market share against large pharmaceutical and biotechnology companies, smaller
companies that are collaborating with larger pharmaceutical companies, new companies, academic institutions,
government agencies and other public and private research organizations. In addition, the pharmaceutical and
biotechnology industry is characterized by rapid technological change. Because our research approach integrates many
technologies, it may be difficult for us to remain current with the rapid changes in each technology. Further, our
competitors may render our technologies obsolete by advancing their existing technological approaches or developing
new or different approaches. If we fail to stay at the forefront of technological change, we may be unable to compete
effectively.
OMIDRIA. We are not aware of any product that directly competes with OMIDRIA and is FDA-approved for
intraoperative delivery in irrigation solutions during surgical procedures; however, OMIDRIA could face competition
from products that are delivered intraoperatively, but that do not include a non-steroidal anti-inflammatory agent, as well
as from preoperative and postoperative treatments for mydriasis, pain or inflammation. Our primary competition for
OMIDRIA comes from surgeons’ current practices, which may include use of products obtained from distributors or
compounding pharmacies at a relatively low cost. Title I (the Compounding Quality Act) of the Drug Quality and
Security Act, which was enacted in November 2013, added Section 503B to the FDCA establishing a distinct category of
drug compounders known as “outsourcing facilities.” Among other provisions, the Compounding Quality Act imposes
restrictions on the materials that may be compounded at registered outsourcing facilities and traditional compounders
and places conditions on the compounding of bulk substances. Surgeons may perceive that, since the enactment of the
Compounding Quality Act, compounding pharmacies, particularly those that are registered as “outsourcing facilities,”
are subject to rigorous regulatory oversight that assures the safety and manufacturing quality of compounded products,
notwithstanding the relatively high frequency of recall events, warning letters and findings of unsanitary conditions
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issued by FDA following inspection of registered outsourcing facilities. In addition, we anticipate that there are some
surgeons who do not use intraoperative mydriatics and may not agree with the value proposition of maintaining pupil
dilation and inhibiting miosis during the procedure, or with the use of a nonsteroidal anti-inflammatory drug
intraoperatively to inhibit inflammation, prevent miosis and reduce postoperative pain. Although we are not aware of
any companies developing similar approaches for maintenance of intraoperative pupil size and postoperative pain
reduction as an FDA-approved product, such strategies may develop. In Europe, an inexpensive mydriatic and local
anesthetic combination product is available but, unlike OMIDRIA, this product does not include an anti-inflammatory
agent.
Product Candidates, Development Programs and Platforms. With respect to our development of therapeutics
targeting complement-mediated disorders, there are multiple companies developing potential therapies targeting the
complement system, although none of these potential therapies, to our knowledge, selectively inhibit the lectin pathway.
Soliris® (eculizumab) and Ultomiris® (ravulizumab-cwvz) are monoclonal complement inhibitors administered
intravenously and approved for commercial use with which our lead MASP-2 inhibitor, narsoplimab (OMS721), and/or
our MASP-3 inhibitor OMS906 will compete, if either is approved for any indication(s) for which Soliris® and/or
Ultomiris® are also approved. Alexion Pharmaceuticals, Inc., the manufacturer of Soliris® and Ultomiris®, has announced
plans to begin a Phase 3 trial of Ultomiris® for HSCT-TMA in the second half of 2020 and has an ongoing Phase 3 trial
of an antibody directed to C5, the same complement target as Soliris® and Ultomiris®, but which can be administered
subcutaneously.
We are aware of other companies attempting to de-orphanize orphan GPCRs. If any of these companies is able to
de-orphanize an orphan GPCR before we unlock this receptor, we may be unable to establish an exclusive or
commercially valuable intellectual property position around that orphan GPCR.
Intellectual Property
We have retained control of all worldwide manufacturing, marketing and distribution rights for OMIDRIA and each
of our product candidates and programs. Some of our products and product candidates and programs are based on
inventions and other intellectual property rights that we acquired through assignments, exclusive licenses or acquisitions
described in further detail under “License and Development Agreements” below.
As of February 12, 2020, we owned or held worldwide exclusive licenses to a total of 76 issued patents and 61
pending patent applications in the U.S. and 914 issued patents and 521 pending patent applications in foreign markets
directed to therapeutic compositions and methods related to our research and development programs. For each program,
our decision to seek patent protection in specific foreign markets, in addition to the U.S., is based on many factors,
including one or more of the following: our available resources, the size of the commercial market, the presence of a
potential competitor or a contract manufacturer in the market and whether the legal authorities in the market effectively
enforce patent rights.
• OMIDRIA-Ophthalmology. OMIDRIA is encompassed by our PharmacoSurgery patent portfolio. The relevant
patents and patent applications in this portfolio are directed to combinations of agents, generic and/or
proprietary to us or to others, drawn from therapeutic classes such as pain and inflammation inhibitory agents,
mydriatic agents and agents that reduce intraocular pressure, delivered locally and intraoperatively to the site of
ophthalmological procedures, including cataract and lens replacement surgery. As of February 12, 2020, we
owned eight issued U.S. patents and three pending U.S. patent applications and 70 issued patents and 84
pending patent applications in foreign markets that are directed to OMIDRIA. Our OMIDRIA patents have
terms that will expire as late as October 23, 2033 and, if currently pending patent applications are issued, as late
as November 30, 2035.
• MASP-2 Program - Narsoplimab (OMS721). We hold worldwide exclusive licenses to rights in connection with
MASP-2, the antibodies targeting MASP-2 and the therapeutic applications for those antibodies from the
University of Leicester, MRC and Helion. As of February 12, 2020, we exclusively controlled 19 issued patents
and 32 pending patent applications in the U.S., and 384 issued patents and 314 pending patent applications in
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foreign markets, related to our MASP-2 program. Our MASP-2 and narsoplimab patents have terms that will
expire as late as 2032 and, if currently pending patent applications are issued, as late as 2039.
• MASP-3 Program - OMS906. We own and exclusively control under a license from the University of Leicester
all rights to methods of treating various disorders and diseases by inhibiting MASP-3. As of February 12, 2020,
we exclusively controlled three pending patent applications in the U.S. and 52 issued and 85 pending patent
applications in foreign markets that are related to our MASP-3 program.
• PPARγ Program - OMS405. As of February 12, 2020, we owned two issued patents and one pending patent
application in the U.S., and 30 issued patents and 10 pending patent applications in foreign markets, directed to
our discoveries linking PPARγ and addictive disorders.
• PDE7 Program - OMS527. As of February 12, 2020, we owned two issued patents and one pending patent
application in the U.S., and 60 issued patents and three pending patent applications in foreign markets directed
to our discoveries linking PDE7 to movement disorders, as well as one issued patent and two pending patent
applications in the U.S., and 48 issued patents and 16 pending patent applications in foreign markets directed to
the link between PDE7 and addiction and compulsive disorders. Additionally, under a license from Daiichi
Sankyo, we exclusively control rights to three issued U.S. patents and 58 issued and four pending patent
applications in foreign markets that are directed to proprietary PDE7 inhibitors. For a more detailed description
of our agreement with Daiichi Sankyo, see “License and Development Agreements” below.
• GPCR Platform. As of February 12, 2020, we owned seven issued patents and 14 pending patent applications in
the U.S., and 56 issued patents and one pending patent application in foreign markets, which are directed to
previously unknown links between specific molecular targets in the brain and a series of CNS disorders, to our
CRA and to other research tools that are used in our GPCR program, and to orphan GPCRs and other GPCRs
for which we have identified functionally interacting compounds using our CRA. Five of the pending patent
applications in the U.S. and the pending patent application in foreign markets are directed to GPR174.
• Antibody Platform. As of February 12, 2020, we owned and/or held worldwide exclusive license rights from the
UW to eight issued patents and one pending patent application in the U.S., and 22 issued patents and eight
pending patent applications in foreign markets, directed to our antibody platform and antibodies generated
using our platform.
All of our employees enter into our standard employee proprietary information and inventions agreement, which
includes confidentiality provisions and provides us ownership of all inventions and other intellectual property made by
our employees that pertain to our business or that relate to our employees’ work for us or that result from the use of our
resources. Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret
protection of the use, formulation and structure of our products and product candidates and the methods used to
manufacture them, as well as on our ability to defend successfully these patents against third-party challenges. Our
ability to protect our products and product candidates from unauthorized making, using, selling, offering to sell or
importing by third parties is dependent on the extent to which we have rights under valid and enforceable patents that
cover these activities.
The patent positions of pharmaceutical, biotechnology and other life sciences companies can be highly uncertain
and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent
policy regarding the breadth of claims allowed in biotechnology patents has emerged to date in the U.S., and tests used
for determining the patentability of patent claims in all technologies are in flux. The pharmaceutical, biotechnology and
other life sciences patent situation outside the U.S. is even more uncertain. Changes in either the patent laws or in
interpretations of patent laws in the U.S. and other countries may diminish the value of our intellectual property.
Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in the patents that we own or have
licensed or in third-party patents.
We sell OMIDRIA under trademarks that we consider in the aggregate to be important to our operations. We have
registered, and intend to maintain, the trademarks “OMEROS”, “OMIDRIA”, “OMIDRIASSURE” and
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“PHARMACOSURGERY” with the U.S. Patent and Trademark Office in connection with the products and services we
offer. We are not aware of any material claims of infringement or other challenges to our right to use the “OMEROS,”
“OMIDRIA,” “OMIDRIASSURE” or “PHARMACOSURGERY” trademarks in the U.S.
Government Regulation
Government authorities in the U.S., the EU and other countries extensively regulate the research, development,
testing, manufacture, labeling, promotion, advertising, distribution, marketing, and export and import of drug and
biologic products such as OMIDRIA and the product candidates that we are developing. Failure to comply with
applicable requirements, both before and after receipt of regulatory approval, may subject us, our third-party
manufacturers, and other partners to administrative and judicial sanctions, such as warning letters, product recalls,
product seizures, a delay in approving or refusal to approve pending applications, civil and other monetary penalties,
total or partial suspension of production or distribution, injunctions, and/or criminal prosecutions.
In the U.S., our products and product candidates are regulated by the FDA as drugs or biologics under the FDCA
and implementing regulations and, in the case of biologics, also under the Public Health Service Act (“PHSA”). In
Europe, our products and product candidates are regulated by the EMA and national medicines regulators under the
rules governing medicinal products in the EU as well as national regulations in individual countries. OMIDRIA has
received marketing approval from the FDA and from the applicable regulatory authorities in the EU. Our product
candidates are in various stages of testing and none of our product candidates has received marketing approval from the
FDA or the applicable regulatory authorities in the EU.
The steps required before a product may be approved for marketing by the FDA, or the applicable regulatory
authorities outside of the U.S., typically include the following:
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formulation development and manufacturing process development;
preclinical laboratory and animal testing;
submission to the FDA of an Investigational New Drug application (“IND”) for human clinical testing, which
must become effective before human clinical trials may begin; and in countries outside the U.S., a Clinical Trial
Application (“CTA”), is filed according to the country’s local regulations;
adequate and well-controlled human clinical trials to establish the efficacy and safety of the product for each
indication for which approval is sought;
adequate assessment of drug product stability to determine shelf life/expiry dating;
in the U.S., submission to the FDA of a New Drug Application (“NDA”), in the case of a drug product, or a
BLA in the case of a biologic product and, in Europe, submission to the EMA or a national regulatory authority
of an MAA;
satisfactory completion of inspections of one or more clinical sites at which clinical trials with the product were
carried out and of the manufacturing facility or facilities at which the product is produced to assess compliance
with Good Clinical Practices (“GCPs”), and cGMPs; and
• FDA review and approval of an NDA or BLA, or review and approval of an MAA by the applicable regulatory
authorities in the EU.
Manufacturing. Manufacturing of drug products for use in clinical trials must be conducted according to relevant
national and international guidelines, for example, cGMP. Process and formulation development are undertaken to
design suitable routes to manufacture the drug substance and the drug product for administration to animals or humans.
Analytical development is undertaken to obtain methods to quantify the potency, purity and stability of the drug
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substance and drug product as well as to measure the amount of the drug substance and its metabolites in biological
fluids, such as blood.
Preclinical Tests. Preclinical tests include laboratory evaluations and animal studies to assess efficacy, toxicity and
pharmacokinetics. The results of the preclinical tests, together with manufacturing information, analytical data, clinical
development plan, and other available information are submitted as part of an IND or CTA.
The IND/CTA Process. An IND or CTA must become effective before human clinical trials may begin. An IND will
automatically become effective 30 days after receipt by the FDA unless, before that time, the FDA raises concerns or
questions and imposes a clinical hold. In that event, the IND sponsor and the FDA must resolve any outstanding FDA
concerns or questions before the clinical hold is lifted and clinical trials can proceed. Similarly, a CTA must be cleared
by the local independent ethics committee and competent authority prior to conducting a clinical trial in the country in
which it was submitted. There can be no assurance that submission of an IND or CTA will result in authorization to
commence clinical trials. Once an IND or CTA is in effect, there are certain reporting requirements.
Clinical Trials. Clinical trials involve the administration of the investigational product to human subjects under the
supervision of qualified personnel and must be conducted in accordance with local regulations and GCPs. Clinical trials
are conducted under protocols detailing, for example, the parameters to be used in monitoring patient safety and the
efficacy criteria, or endpoints, to be evaluated. Each trial must be reviewed and approved by an independent institutional
review board or ethics committee for each clinical site at which the trial will be conducted before it can begin. Clinical
trials are typically conducted in three defined phases, but the phases may overlap or be combined:
• Phase 1 usually involves the initial administration of the investigational product to human subjects, who may or
may not have the disease or condition for which the product is being developed, to evaluate the safety, dosage
tolerance, pharmacodynamics and, if possible, to gain an early indication of the effectiveness of the product.
• Phase 2 usually involves trials in a limited patient population with the disease or condition for which the
product is being developed to evaluate appropriate dosage, to identify possible adverse side effects and safety
risks, and to evaluate preliminarily the effectiveness of the product for specific indications.
• Phase 3 clinical trials usually further evaluate and confirm effectiveness and test further for safety by
administering the product in its final form in an expanded patient population.
We, our product development partners, institutional review boards or ethics committees, the FDA or other
regulatory authorities may suspend clinical trials at any time on various grounds, including a belief that the subjects are
being exposed to an unacceptable health risk.
Disclosure of Clinical Trial Information. Sponsors of clinical trials of certain FDA-regulated products, including
prescription drugs, are required to register and disclose certain clinical trial information on a public website maintained
by the U.S. National Institutes of Health. Information related to the product, patient population, phase of investigation,
study sites and investigator, and other aspects of the clinical trial is made public as part of the registration. Sponsors are
also obligated to disclose the results of these trials after completion. Disclosure of the results of these trials can be
delayed for up to two years if the sponsor certifies that it is seeking approval of an unapproved product or that it will file
an application for approval of a new indication for an approved product within one year. Clinical trials conducted in
European countries are required to be registered at a similar public database maintained and overseen by European
health authorities. Competitors may use this publicly available information to gain knowledge regarding the design and
progress of our development programs.
The Application Process. If the necessary clinical trials are successfully completed, the results of the preclinical
trials and the clinical trials, together with other detailed information, including information on the manufacture and
composition of the product, are submitted to the FDA in the form of an NDA or a BLA, as applicable, and to the EMA
or national regulators in the form of an MAA, requesting approval to market the product for a specified indication. In the
EU, an MAA may be submitted to the EMA for review and, if the EMA gives a positive opinion, the EC may grant a
marketing authorization that is valid across the EU (centralized procedure). Alternatively, an MAA may be submitted to
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one or more national regulators in the EU according to one of several national or decentralized procedures. The type of
submission in Europe depends on various factors and must be cleared by the appropriate authority prior to submission.
For most of our product candidates, the centralized procedure will be either mandatory or available as an option.
If the regulatory authority determines that the application is not acceptable, it may refuse to accept the application
for filing and review, outlining the deficiencies in the application and specifying additional information needed to file
the application. Notwithstanding the submission of any requested additional testing or information, the regulatory
authority ultimately may decide that the application does not satisfy the criteria for approval. Before approving an NDA
or BLA, or an MAA, the FDA or the EMA, respectively, may inspect one or more of the clinical sites at which the
clinical studies were conducted to ensure that GCPs were followed and may inspect facilities at which the product is
manufactured to ensure satisfactory compliance with cGMP. After approval, changes to the approved product such as
adding new indications, manufacturing changes, or additional labeling claims will require submission of a supplemental
application, referred to as a variation in the EU, or, in some instances, a new application, for further review and
approval. The testing and approval process requires substantial time, effort, and financial resources, and we cannot be
sure that any future approval will be granted on a timely basis, if at all.
Some of our drug products may be eligible for NDA submissions to the FDA for approval under the
Section 505(b)(2) process. Section 505(b)(2) applications may be submitted for drug products that represent a
modification, such as a new indication or new dosage form, of a previously approved drug.
Section 505(b)(2) applications may rely on the FDA’s previous findings for the safety and effectiveness of the
previously approved drug in addition to information obtained by the 505(b)(2) applicant to support the modification of
the previously approved drug. Preparing Section 505(b)(2) applications may be less costly and time-consuming than
preparing an NDA that is based entirely on new data and information.
Some of our product candidates, such as those from our MASP-2 and MASP-3 programs, are considered biologics
because they are derived from natural sources as opposed to being chemically synthesized. The added complexity
associated with manufacturing biologics may result in additional monitoring of the manufacturing process and product
changes.
In addition, we, our suppliers and our contract manufacturers are required to comply with extensive regulatory
requirements both before and after approval. For example, we must establish a pharmacovigilance system and are
required to report adverse reactions and production problems, if any, to the regulatory authorities. We must also comply
with certain requirements concerning advertising and promotion for our products. The regulatory authorities may impose
specific obligations as a condition of the marketing authorization, such as additional safety monitoring, or the conduct of
additional clinical trials or post-marketing safety studies. Also, quality control and manufacturing procedures must
continue to conform to cGMPs after approval. Accordingly, manufacturers must continue to expend time, money, and
effort in all areas of regulatory compliance, including production and quality control to comply with cGMPs. In addition,
discovery of problems such as safety issues may result in changes in labeling or restrictions on a product manufacturer or
marketing authorization holder, including removal of the product from the market.
Fast-Track and Priority Review Designations. Section 506(b) of the FDCA provides for the designation of a drug as
a fast-track product if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a
serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for
such a disease or condition. A program with fast-track status is afforded greater access to the FDA for the purpose of
expediting the product’s development, review and potential approval. Many products that receive fast-track designation
are also considered appropriate to receive priority review, and their respective applications may be accepted by the FDA
as a rolling submission in which portions of an NDA or BLA are reviewed before the complete application is submitted.
Together, these may reduce time of development and FDA review time. In Europe, products that are considered to be of
major public health interest are eligible for accelerated assessment, which shortens the review period. The grant of fast-
track status, priority review or accelerated assessment does not alter the standard regulatory requirements for obtaining
marketing approval.
Breakthrough Therapy Designation. In 2012, Congress enacted the Food and Drug Administration Safety and
Innovation Act. This law established a regulatory process allowing for increased interactions with the FDA with the goal
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of expediting development and review of products designated as “breakthrough therapies.” A product may be designated
as a breakthrough therapy if it is intended, either alone or in combination with one or more other products, to treat a
serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may
demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as
substantial treatment effects observed early in clinical development. The FDA may take certain actions with respect to
breakthrough therapies, including holding meetings with the sponsor throughout the development process; providing
timely advice to the product sponsor regarding development and approval; involving more senior staff in the review
process; assigning a cross-disciplinary project lead for the review team; and taking other steps to design the clinical trials
in an efficient manner.
Accelerated Approval. The FDA may grant accelerated approval to a product for a serious or life-threatening
condition that provides a meaningful therapeutic advantage to patients over existing treatments based upon a
determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.
The FDA may also grant accelerated approval for such a condition when the product has an effect on an intermediate
clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality and that is reasonably
likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. In both cases, FDA must take
into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
Studies that are conducted to demonstrate a drug’s effect on a surrogate or intermediate clinical endpoint for accelerated
approval must be adequate and well-controlled as required by the FDCA.
Following accelerated approval, the FDA requires that the company provide confirmatory evidence, which may
include certain adequate and well-controlled post-marketing clinical studies to verify and describe the clinical benefit of
the product, and the FDA may impose restrictions on distribution to assure safe use. Confirmatory studies are typically
required to be underway at the time of the accelerated approval. If the required confirmatory studies fail to verify the
clinical benefit of the drug, or if the applicant fails to perform the required confirmatory studies with due diligence, the
FDA may withdraw approval of the drug under streamlined procedures in accordance with the Agency’s regulations.
The Agency may also withdraw approval of a drug if, among other things, other evidence demonstrates that the drug
product is not shown to be safe or effective under its conditions of use.
The EU also has accelerated approval programs. In the EU, a marketing authorization may be granted on the basis
of less complete data than are normally required in certain “exceptional circumstances,” such as when the product’s
indication is encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive data.
Alternatively, a conditional marketing authorization may be granted prior to obtaining the comprehensive clinical data
required for a full MAA if a product fulfills an unmet medical need and the benefit to public health of the product’s
immediate availability outweighs the risk inherent in the incomplete data.
Orphan Drug Designation. Under the Orphan Drug Act (“ODA”), the FDA may grant orphan drug designation to
drugs or biologics intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the U.S. or
more than 200,000 individuals in the U.S. for which the cost of developing and making the product available in the U.S.
for this type of disease or condition is not likely to be recovered from U.S. sales for that product. The granting of orphan
designation does not alter the standard regulatory requirements (other than payment of certain fees), nor does it alter the
standards or process for obtaining marketing approval. If a product that has an orphan drug designation subsequently
receives the first FDA approval for the indication for which it has been designated as an orphan drug, the sponsor of the
product qualifies for various development incentives specified in the ODA, including a tax credit of up to 25% of
expenditures on qualified clinical testing for the orphan drug. Furthermore, the product is entitled to an orphan drug
exclusivity period, which means that the FDA may not grant approval to any other application to market the same drug
for the same indication for a period of seven years except in limited circumstances, such as a showing of clinical
superiority to the product with orphan drug exclusivity for the protected indication. If the FDA designates an orphan
drug based on a finding of clinical superiority, the FDA must provide a written notification to the sponsor that states the
basis for orphan designation, including “any plausible hypothesis” relied on by the FDA. The FDA must also publish a
summary of its clinical superiority findings upon granting orphan drug exclusivity based on clinical superiority. Orphan
drug exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the
same drug for a different disease or condition. The EU has a similar Orphan Drug program to that of the U.S., and it is
administered through the EMA’s Committee for Orphan Medicinal Products.
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Pediatric Testing and Exclusivity. In the U.S., NDAs and BLAs are subject to both mandatory pediatric testing
requirements and voluntary pediatric testing incentives in the form of exclusivity. An additional six months of
exclusivity in the U.S. may be granted to a sponsor of an NDA or BLA if the sponsor conducts certain pediatric studies.
This process is initiated when the FDA issues a Written Request for pediatric studies to determine if the drug or biologic
could have meaningful pediatric health benefits. If the FDA determines that the sponsor has conducted the requested
pediatric studies in accordance with the written request, then an additional six months of exclusivity may attach in the
case of a drug to any other regulatory exclusivity or patent protection applicable to the drug and, in the case of a
biologic, to any other regulatory exclusivity applicable to the biologic. The EU has a similar requirement and incentive
for the conduct of pediatric studies according to the pediatric investigation plan, which must be adopted by the EMA
before an MAA may be submitted.
Expanded Access. “Expanded access” refers to the use of an investigational drug where the primary purpose is to
diagnose, monitor, or treat a patient’s disease or condition rather than to collect information about the safety or
effectiveness of a drug. There are three FDA-recognized categories of expanded access trials: expanded access for
individual patients, including for emergency use; expanded access for intermediate-size patient populations; and
expanded access for large patient populations under a treatment IND or treatment protocol. For all types of expanded
access, the FDA must determine prior to authorizing expanded access that: (1) the patient or patients to be treated have a
serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy; (2) the
potential patient benefit justifies the potential risks of use and that the potential risks are not unreasonable in the context
of the disease or condition to be treated; and (3) granting the expanded access will not interfere with the initiation,
conduct, or completion of clinical studies in support of the drug’s approval. Only a licensed physician or the drug’s
manufacturer may apply for expanded access. Manufacturers are not required to supply the investigational product. The
FDA has established streamlined processes for physicians to request individual patient expanded access whereby
physicians can submit an abbreviated application. In cases of individual patient emergency expanded access, physicians
can receive FDA approval for access by phone and follow up with the abbreviated form. In addition, the sponsor of an
expanded access IND must submit IND safety reports and, in the cases of protocols continuing for one year or longer,
annual reports to the FDA. Expanded access programs are not intended to yield information relevant to evaluating a
drug’s effectiveness for regulatory purposes. INDs for expanded access trials may be sponsored by physicians or by
manufacturers.
U.S. Labeling, Marketing and Promotion. The FDA closely regulates the labeling, marketing and promotion of
drugs. Failure to comply with these requirements can result in adverse publicity, warning letters, corrective advertising,
injunctions and potential civil and criminal penalties.
In addition to regulation by the FDA, the research, manufacturing, distribution, sale and promotion of drug products
in the U.S. are potentially subject to regulation by various federal, state and local authorities, including CMS, other
divisions of the U.S. Department of Health and Human Services (e.g., the Office of Inspector General), the U.S.
Department of Justice, state Attorneys General, and other state and local government agencies. All of these activities are
also potentially subject to federal and state consumer protection and unfair competition laws. Violations of these laws
are punishable by prison sentences, criminal fines, administrative civil money penalties, and exclusion from participation
in federal healthcare programs.
There are also an increasing number of state laws that require manufacturers to make reports to states on pricing and
marketing information or impose other special requirements for the sale and marketing of drug products. Many of these
laws contain ambiguities as to what is required to comply with the laws. In addition, federal and state “transparency
laws” require manufacturers to track and report certain payments made to healthcare providers and, under some state
laws, other information concerning our products. These laws may affect our sales, marketing and other promotional
activities by imposing administrative and compliance burdens on us. In addition, our reporting actions could be subject
to the penalty provisions of the pertinent state and federal authorities.
Drug Supply Chain Security Act. Title II (the Drug Supply Chain Security Act (the “DSCSA”)), of the Drug Quality
and Security Act imposes on manufacturers of certain pharmaceutical products new obligations related to product
tracking and tracing, among others, which began a several-year phase-in process in 2015. Among the requirements of
this legislation, manufacturers subject to the DSCSA are required to provide certain documentation regarding the drug
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product to trading partners to which product ownership is transferred, label drug product with a product identifier (i.e.,
serialize), respond to verification requests from trading partners, provide transaction documentation upon request by
federal or state government entities, and keep certain records regarding the drug product. The transfer of information to
subsequent product owners by manufacturers must be done electronically. For products and transactions falling within
DSCSA’s scope, manufacturers are required to verify that purchasers of the manufacturers’ products are appropriately
licensed. Further, under the DSCSA, covered manufacturers have drug product investigation, quarantine, disposition,
and notification responsibilities for product that is reasonably believed or that credible evidence shows to be counterfeit,
diverted, stolen, intentionally adulterated such that the product would result in serious adverse health consequences or
death, the subject of fraudulent transactions or otherwise unfit for distribution such that they would be reasonably likely
to result in serious health consequences or death. Anti-counterfeiting and serialization requirements similar to those
under the DSCSA have also been adopted in the EU and became effective in February 2019.
Foreign Regulatory Requirements. Outside of the U.S., our ability to conduct clinical trials or market our products
will also depend on receiving the requisite authorizations from the appropriate regulatory authorities. The foreign
regulatory approval processes include similar requirements and many of the risks associated with the FDA and/or the EU
approval process described above, although the precise requirements may vary from country to country. In the EU, once
an MAA is granted, the product must be “placed on the market” in at least one EEA country within three years of the
date of authorization. “Placed on the market” is defined as when the medicinal product is “released into the distribution
chain,” i.e., out of the direct control of the marketing authorization holder. In July 2018, we placed OMIDRIA on the
market in the EU, on a limited basis, which maintained the ongoing validity of the European marketing authorization for
OMIDRIA. A marketing authorization will cease to be valid if a product previously placed on the market is no longer
actually present on the market for three consecutive years.
Hatch-Waxman Act. In seeking approval for a drug through an NDA, applicants are required to list with the FDA
each patent with claims that cover the applicant’s drug or an approved method of use of the drug. 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 competitors in support of approval of an ANDA or a 505(b)(2) application. An ANDA
provides for marketing of a drug that has the same active ingredients and, in some cases (e.g., ophthalmology), also the
same inactive ingredients, in the same strengths and dosage form as the listed drug and has been shown through testing
to be bioequivalent to the listed drug or receives a waiver from bioequivalence testing. ANDA applicants are generally
not required to conduct or submit results of preclinical or clinical tests to prove the safety or effectiveness of their drug,
other than the requirement for bioequivalence testing. Drugs approved in this way are considered therapeutically
equivalent, and are commonly referred to as “generic equivalents” to the listed drug. These drugs then generally can be
substituted by pharmacists under prescriptions written for the original listed drug.
The ANDA or 505(b)(2) applicant is required to certify to the FDA concerning any patents listed for the referenced
approved drug in the FDA’s Orange Book. Specifically, the applicant must certify that: (1) the required patent
information has not been filed; (2) the listed patent has expired; (3) the listed patent has not expired but will expire on a
particular date and approval is sought after patent expiration; or (4) the listed patent is invalid, unenforceable or will not
be infringed by the new drug. A certification that the new drug will not infringe the already approved drug’s listed
patents or that such patents are invalid or unenforceable is called a Paragraph IV certification. If the ANDA or
505(b)(2) applicant does not include a Paragraph IV certification, the ANDA or 505(b)(2) application will not be
approved until all of the listed patents claiming the referenced drug have expired, except for any listed patents that only
apply to uses of the drug not being sought by the ANDA or 505(b)(2) applicant.
If the ANDA or 505(b)(2) applicant has made a Paragraph IV certification, the applicant must also send notice of a
Paragraph IV Notice Letter to the NDA and patent holders once the ANDA or 505(b)(2) application 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 Notice Letter. The filing of a patent infringement lawsuit within 45 days of the receipt of
notice of a Paragraph IV Notice Letter automatically prevents the FDA from approving the ANDA until the earlier of
30 months, expiration of the patent, settlement of the lawsuit, modification by a court or a decision in the infringement
case that is favorable to the ANDA or 505(b)(2) applicant.
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The ANDA or 505(b)(2) application also will not be approved until any applicable non-patent exclusivity, such as
exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced drug has
expired. The U.S. Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the
Hatch-Waxman Act, provides a period of five years following approval of a drug containing no previously approved
active moiety, during which ANDAs for generic versions of those drugs and 505(b)(2) applications referencing those
drugs cannot be submitted unless the submission contains a Paragraph IV challenge to a listed patent, in which case the
submission may be made four years following the original drug approval. Federal law provides for a period of
three years of exclusivity following approval of a listed drug that contains previously approved active ingredients but is
approved in a new dosage form, route of administration or combination, or for a new use, the approval of which was
supported by new clinical trials other than bioavailability studies that were essential to the approval and conducted by or
for the sponsor. During those three years of exclusivity, FDA cannot grant approval of an ANDA or
505(b)(2) application for the protected dosage form, route of administration or combination, or use of that listed drug.
In December 2019, a piece of legislation referred to as the Creating and Restoring Equal Access to Equivalent
Samples Act of 2019 (“CREATES Act”) was signed into law, which is intended to address the concern that some brand
manufacturers have improperly denied generic and biosimilar product developers access to samples of brand products.
The CREATES Act establishes a private cause of action that permits a generic or biosimilar product developer to sue the
brand manufacturer to compel it to furnish the necessary samples on commercially reasonable, market-based terms. If
the developer prevails, the court may grant the developer a monetary award up to the brand product’s revenue for the
period of delay in providing samples.
Biosimilars. In the U.S., the FDA regulates biologics under the FDCA, the PHSA, and implementing regulations.
The enactment of federal health care reform legislation in March 2010 provided a new pathway for approval of follow-
on biologics (i.e., biosimilars) under the PHSA. Licensure by the FDA is dependent upon many factors, including a
showing that the proposed biosimilar is “highly similar” to the reference product, notwithstanding minor differences in
clinically inactive components, and has no clinically meaningful differences from the reference product in terms of
safety, purity, and potency. The types of data ordinarily required in a biosimilar application to show high similarity
include analytical data, animal studies (including toxicity studies), and clinical studies (including immunogenicity and
pharmacokinetic/pharmacodynamic studies). A biosimilar must seek licensure for a condition of use for which the
reference product is licensed.
Furthermore, the PHSA provides that for a biosimilar to be considered “interchangeable” (i.e., the biological
product may be substituted for the reference product without the intervention of the health care provider who prescribed
the reference product), the applicant must make an additional showing that the biosimilar can be expected to produce the
same clinical result as the reference product in any given patient, and if the product is administered more than once to a
patient, that risks in terms of safety or diminished efficacy of alternating or switching between the biological product and
the reference product is no greater than the risk of using the reference product without switching. Although the FDA has
provided guidance on what information and data an applicant should submit to enable an interchangeability
determination, thus far the FDA has not licensed any biologic as being interchangeable with its reference product.
In the EU, a pathway for the approval of biosimilars has existed since 2005.
Healthcare compliance laws. In the U.S., commercialization of OMIDRIA and our product candidates, if approved,
is subject to regulation and enforcement under a number of federal and state healthcare compliance laws administered
and enforced by various agencies. These include, but are not limited to, the following:
•
•
the federal Anti-Kickback Statute, which prohibits offering or paying anything of value to a person or entity to
induce or reward referrals for goods or services reimbursed by a federal health care program such as Medicare
or Medicaid;
the federal False Claims Act, which prohibits presenting or causing to be presented a false claim for payment by
a federal health care program, and which has been interpreted to also include claims caused by improper drug-
manufacturer product promotion or the payment of kickbacks;
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•
•
a variety of governmental pricing, price reporting, and rebate requirements, including those under Medicaid and
the Veterans Health Care Act; and
the so-called Sunshine Act and certain provisions of the Affordable Care Act, which require that we report to
the federal government information on certain financial payments and other transfers of value made to certain
healthcare providers and institutions, as well as certain information regarding our distribution of drug samples.
In addition to these federal law requirements, several U.S. states have enacted similar laws requiring periodic
reporting and/or disclosure related to our marketing, sales and other activities, or regulating certain sales and marketing
activities, such as provision of meals, gifts or entertainment to certain healthcare providers. We may also be subject to
federal or state privacy laws if we receive protected patient health information.
Similar requirements apply to our operations outside of the U.S. Laws in the U.S. such as the Foreign Corrupt
Practices Act prohibit the offering or payment of bribes or inducements to foreign public officials for business, including
physicians or other medical professionals who are employees of public health care entities. In addition, many non-U.S.
jurisdictions in which we operate, or may operate in the future, have their own laws similar to the healthcare compliance
laws that exist in the U.S.
Pharmaceutical Pricing and Reimbursement
Overview. In both U.S. and foreign markets, our ability to commercialize our products and product candidates
successfully, and to attract commercialization partners for our products and product candidates, depends in significant
part on the availability of adequate financial coverage and reimbursement from third-party payers including, in the U.S.,
managed care organizations and other private health insurers as well as governmental payers such as the Medicare and
Medicaid programs. Reimbursement by a third-party payer may depend on a number of factors, including the payer’s
determination that use of a product is:
•
•
•
•
•
a covered benefit under its health plan;
safe, effective and medically necessary;
appropriate for the specific patient;
cost-effective; and
neither experimental nor investigational.
Reimbursement by government payers is based on statutory authorizations and complex regulations that may change
with annual or more frequent rulemaking, as well as legislative reform measures.
Third-party private and governmental payers are increasingly challenging the prices charged for medicines and
examining their cost-effectiveness in addition to their safety and efficacy. We may need to conduct expensive
pharmacoeconomic studies in order to demonstrate the cost effectiveness of our products or product candidates. Even
with the availability of such studies, third-party private and/or governmental payers may not provide coverage and
reimbursement for our products or product candidates, in whole or in part.
United States. Political, economic and regulatory influences are subjecting the healthcare industry in the U.S. to
fundamental changes. There have been, and we expect there will continue to be, legislative and regulatory proposals to
change the healthcare system in ways that could significantly affect our business. For example, the 2010 Affordable Care
Act (the “ACA”), is intended to broaden access to health insurance, reduce or constrain the growth of healthcare
spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health
insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.
Other legislative changes included a two percent across-the-board reduction to Medicare payments to providers,
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effective April 1, 2013, which, due to subsequent legislative amendments, will stay in effect through fiscal year 2025
unless additional congressional action is taken. The American Taxpayer Relief Act of 2012, among other things, reduced
Medicare payments to several providers, and increased the period for the government to recover overpayments to
providers from three to five years. President Trump and various members of Congress have expressed a desire to repeal
all or portions of the ACA and, in December 2017, portions of the ACA dealing with the individual mandate insurance
requirement were effectively repealed by the Tax Cuts and Jobs Act of 2017. In December 2018, a federal district court
judge in Texas found the ACA’s individual mandate to be unconstitutional and, therefore, the entire law to be invalid. In
December 2019, the Fifth Circuit affirmed the ruling regarding the individual mandate but remanded the case to the
district court for additional analysis of the question of severability and whether portions of the law remain valid. The
case has been appealed to the Supreme Court and on March 2, 2020, the Supreme Court announced that it would hear
oral argument during its next term. President Trump, the Secretary of Health and Human Services, various members of
Congress and CMS have made statements and/or issued proposals regarding containment of drug prices through various
means, including enabling CMS to negotiate U.S. drug pricing, aligning U.S. drug pricing with foreign drug pricing,
pricing transparency measures, reform of drug rebate programs, and conditioning coverage and reimbursement of certain
drugs upon the prior failure or inadequacy of less expensive therapies (sometimes referred to as “step therapy”). We
cannot predict the ultimate content, timing or effect of any healthcare reform legislation or executive order or the impact
that the resulting changes may have on us.
We are unable to predict what additional legislation, regulations, policies or court orders, if any, relating to the
healthcare industry or coverage and reimbursement may be enacted or imposed in the future or what effect such
legislation, regulations, policies or court orders would have on our business. Any cost-containment measures, including
those listed above, or other healthcare system reforms that are adopted could have a material adverse effect on our
business prospects and financial operations.
Europe. Governments in the various member states of the EU influence or control the price of medicinal products in
their countries through their pricing and reimbursement rules and control of national healthcare systems that fund a large
part of the cost of those products to consumers. To obtain reimbursement or pricing approval, some of these countries
may require the completion of clinical trials or pharmacoeconomic studies that assess the cost-effectiveness of a product
or product candidate relative to currently available therapies or relative to a specified standard. The downward pressure
on healthcare costs in general, and prescription medicines in particular, has become very intense and is creating
increasingly high barriers to the entry of new products in these markets.
Research and Development
We have built a research and development organization that includes expertise in discovery research, preclinical
development, product formulation, analytical and medicinal chemistry, manufacturing, clinical development and
regulatory and quality assurance. We operate cross-functionally and are led by an experienced management team. We
use rigorous project management techniques to make disciplined strategic decisions regarding our research and
development programs and to limit the risk profile of our product pipeline. We also access relevant market information
and key opinion leaders in creating target product profiles and, when appropriate, as we advance our programs to
commercialization. We engage third parties on a limited basis to conduct portions of our preclinical research; however,
we are not substantially dependent on any third parties for our preclinical research nor do any of these third parties
conduct a major portion of our preclinical research. We also engage multiple clinical sites to conduct our clinical trials.
None of these sites conduct the major portion of our clinical trials and we are not substantially dependent on any one of
them.
Employees
As of December 31, 2019, we had 258 full-time employees, 60 of whom are in research and development, 151 of
whom are in sales and marketing and 47 of whom are in finance, legal, business development and administration. Our
full-time employees include eight with M.D.s and 38 with Ph.Ds., of whom one and 21, respectively, are in research and
development. None of our employees is represented by a labor union, and we consider our employee relations to be
good.
26
Information about Our Executive Officers and Significant Employees
The following table provides information regarding our executive officers and significant employees as of March 2,
2020:
Name
Executive Officers:
Gregory A. Demopulos, M.D. . . . . .
Age
Position(s)
Michael A. Jacobsen . . . . . . . . . . . . .
Peter B. Cancelmo, J.D. . . . . . . . . . .
Significant Employees:
Christopher S. Bral, Ph.D. . . . . . . . .
Timothy M. Duffy . . . . . . . . . . . . . . .
George A. Gaitanaris, M.D., Ph.D. .
Daniel G. Kirby . . . . . . . . . . . . . . . . .
Bruce Meiklejohn, Ph.D. . . . . . . . . .
Catherine A. Melfi, Ph.D. . . . . . . . . .
Tina Quinton, J.D., M.S. . . . . . . . . . .
J. Steven Whitaker, M.D., J.D. . . . . .
61
61
41
54
59
63
48
60
60
57
64
President, Chief Executive Officer and Chairman of the Board of
Directors
Vice President, Finance, Chief Accounting Officer and Treasurer
Vice President, General Counsel and Secretary
Vice President, Nonclinical Development
Vice President, Business Development
Vice President, Science and Chief Scientific Officer
Vice President, Chief Commercial Officer
Vice President, Chemistry, Manufacturing and Controls
Vice President, Regulatory Affairs & Quality Systems and Chief
Regulatory Officer
Vice President, Patents
Vice President, Chief Medical Officer
Gregory A. Demopulos, M.D. founded our company and has served as our president, chief executive officer and
chairman of the board of directors since June 1994. He also served as our chief financial officer and treasurer from
January 2009 to October 2013 in an interim capacity and as our chief medical officer from June 1994 to March 2010.
Prior to founding Omeros, Dr. Demopulos completed his residency in orthopedic surgery at Stanford University and his
fellowship training in hand and microvascular surgery at Duke University. Dr. Demopulos currently serves on the board
of trustees of the Smead Funds Trust, an open-end mutual fund company registered under the Investment Company Act
of 1940. Dr. Demopulos received his M.D. from the Stanford University School of Medicine and his B.S. from Stanford
University. Dr. Demopulos is the brother of Peter A. Demopulos, M.D., a member of our board of directors.
Michael A. Jacobsen has served as our vice president, finance, chief accounting officer and treasurer since
October 2013. Prior to joining Omeros, Mr. Jacobsen served as vice president of finance of Sarepta Therapeutics, Inc.
from September 2011 to May 2013 and as its chief accounting officer from September 2011 to December 2012. From
April 2007 to August 2011, Mr. Jacobsen was vice president and chief accounting officer at ZymoGenetics, Inc. Prior to
his service with ZymoGenetics, Mr. Jacobsen held various roles at ICOS Corporation, including senior director of
finance and corporate controller. From April 1995 to October 2001, Mr. Jacobsen held vice president of finance or chief
financial officer roles at three companies in the software, computer hardware and internet retailing industries, two of
which were publicly traded. Mr. Jacobsen is a certified public accountant and received his bachelor’s degree in
accounting from Idaho State University.
Peter B. Cancelmo, J.D. has served as our vice president, general counsel and secretary since June 2019. He joined
Omeros as deputy general counsel, corporate governance and securities in January 2019. Prior to joining Omeros,
Mr. Cancelmo was a principal and shareholder at Garvey Schubert Barer, P.C., where he represented clients in the life
sciences and other technology industries in mergers, acquisitions, strategic alliances, public and private securities
offerings, and a range of other corporate, commercial and financial transactions. He served as chair of the firm’s
business practice group from 2016 until his departure in December 2018. Mr. Cancelmo previously practiced corporate
and transactional law at Davies, Ward, Philips and Vineberg LLP, in New York, and Choate, Hall & Stewart LLP, in
Boston. Mr. Cancelmo received his J.D. from Boston University and his B.A. from Saint Michael’s College.
Christopher S. Bral, Ph.D. has served as our vice president, nonclinical development since October 2015. From
April 2014 to October 2015, Dr. Bral was the executive director, toxicology at Arrowhead Research Corporation, a
biopharmaceutical company. From June 2008 to April 2014, Dr. Bral served as director, drug safety evaluation at Vertex
Pharmaceuticals, a biotechnology company. Prior to Vertex, Dr. Bral held various pre-clinical drug safety positions of
27
increasing responsibility at Schering-Plough Research Institute including associate director, drug safety evaluation.
Dr. Bral received his Ph.D. in biochemistry and biophysics from Texas A&M University and his B.S. in chemistry from
John Carroll University. He has been board-certified in toxicology through the American Board of Toxicology since
2000.
Timothy M. Duffy has served as our vice president, business development since March 2010. From November 2008
to March 2010, Mr. Duffy served as the managing director of Pacific Crest Ventures, a life science consulting firm that
he founded. From June 2004 through September 2008, Mr. Duffy served at MDRNA, Inc. (formerly Nastech
Pharmaceutical Company, Inc.), a biotechnology company. At MDRNA, he held roles of increasing responsibility in
marketing and business development, most recently as the chief business officer. Prior to MDRNA, Mr. Duffy served as
vice president, business development at Prometheus Laboratories, Inc., a specialty pharmaceutical company, and as a
customer marketing manager at The Procter & Gamble Company. Mr. Duffy received his B.S. from Loras College.
George A. Gaitanaris, M.D., Ph.D. has served as our vice president, science since August 2006 and as our chief
scientific officer since January 2012. From August 2003 until our acquisition of nura, inc., in August 2006,
Dr. Gaitanaris served as the chief scientific officer of nura, a company that he co-founded, and that developed treatments
for central nervous system disorders. From 2000 to 2003, Dr. Gaitanaris served as president and chief scientific officer
of Primal, Inc., a biotechnology company that was acquired by nura in 2003. Prior to co-founding Primal, Dr. Gaitanaris
served as staff scientist at the National Cancer Institute. Dr. Gaitanaris received his Ph.D. in cellular, molecular and
biophysical studies and his M.Ph. and M.A. from Columbia University and his M.D. from the Aristotelian University of
Greece.
Daniel G. Kirby has served as our chief commercial officer since August 2019 and as our vice president, head of
commercial since November 2018. From March 2018 until September 2018 Mr. Kirby was the U.S. CAR T-cell
commercial lead for Celgene Corporation, having joined Celgene following its acquisition of Juno Therapeutics, Inc.
Mr. Kirby served as Juno’s Vice President of Market and Market Access from March 2016 until its acquisition by
Celgene in March 2018. Prior to his work at Celgene and Juno, Mr. Kirby was the head of marketing at Medivation, Inc.
from 2015 to 2016, and spent nearly 15 years in commercial leadership roles at Amgen Inc. In his final role at Amgen,
Mr. Kirby oversaw the U.S. customer-facing marketing efforts for the G-CSF franchise, NEULASTA® and
NEUPOGEN®. Mr. Kirby’s experience also includes commercial roles at GlaxoSmithKline. Mr. Kirby holds an
undergraduate degree from the University of Maryland at College Park.
Bruce Meiklejohn, Ph.D. has served as our vice president, chemistry, manufacturing and controls (CMC) since
October 2019. Prior to joining Omeros in this role, Dr. Meiklejohn was an expert CMC consultant for several
biotechnology companies, including Omeros. His consulting work followed a career at Eli Lilly and Company, where he
held a number of CMC leadership roles including head of Lilly’s biopharmaceutical product development division and
senior research fellow in regulatory affairs CMC. While at Lilly, Dr. Meiklejohn led or played a key role in CMC
activities for a number of multibillion-dollar drugs, including Trulicity®, Cialis®, Alimta®, Forteo®, and Cymbalta®.
Dr. Meiklejohn earned his Ph.D. in analytical chemistry and his B.S. in biology and chemistry at Colorado State
University.
Catherine A. Melfi, Ph.D. has served as our vice president, regulatory affairs and quality systems since
October 2012 and has served as our chief regulatory officer since April 2016. Dr. Melfi previously served from
January 1996 to September 2012 at Eli Lilly and Company, where she held technical and leadership roles of increasing
scope and responsibility, including as senior director and scientific director in global health outcomes and regulatory
affairs, respectively. Prior to joining Eli Lilly, Dr. Melfi held various faculty and research positions at Indiana
University, including appointments in its Economics Department, in the School of Public and Environmental Affairs,
and in the Indiana University School of Medicine. Dr. Melfi received her Ph.D. in Economics from the University of
North Carolina - Chapel Hill and B.S. in Economics from John Carroll University.
Tina Quinton, J.D., M.S. has served as our vice president, patents, since June 2019 and previously served as our
deputy general counsel, patents from August 2017 to June 2019 and as associate general counsel, patents from 2012 to
2017. Prior to joining Omeros, Ms. Quinton was a partner with the firm Christensen O'Connor Johnson & Kindness,
PLLC, where she represented clients in the biotechnology and medical sciences industries in all aspects of worldwide
28
patent procurement and enforcement. Before Christensen O'Connor Johnson & Kindness, Ms. Quinton was a research
scientist at several biotechnology companies and centers, including ZymoGenetics, Targeted Genetics Corporation and
Fred Hutchinson Cancer Research Center. Ms. Quinton received her J.D. and her M.S. in Molecular and Cellular
Biology from the University of Washington and her B.S. from Gordon College.
J. Steven Whitaker, M.D., J.D. has served as our vice president, clinical development since joining Omeros in 2010,
and served as our chief medical officer from March 2010 to August 2018 and since November 2019. From May 2008 to
March 2010, Dr. Whitaker served as the chief medical officer, vice president of clinical development at Allon
Therapeutics, Inc., a biotechnology company focused on developing drugs for neurodegenerative diseases. From
August 2007 to May 2008, he served as a medical consultant to Accelerator Corporation, a biotechnology-company
investor and incubator. From May 1994 to May 2007, Dr. Whitaker served at ICOS Corporation, which was acquired by
Eli Lilly and Company in 2007. At ICOS, he held roles of increasing responsibility in clinical research and medical
affairs, most recently as divisional vice president, clinical research as well as medical director of the Cialis® global
product team. Dr. Whitaker received his M.D. from the Indiana University School of Medicine, his J.D. from the
University of Washington and his B.S. from Butler University.
Corporate Information
We were incorporated in 1994 as a Washington corporation. Our principal executive offices are located at 201
Elliott Avenue West, Seattle, Washington, 98119, and our telephone number is (206) 676-5000. Our website address is
www.omeros.com. We make available, free of charge through our investor relations website at investor.omeros.com, our
annual report on Form 10-K, our quarterly reports on Form 10-Q, our current reports on Form 8-K and amendments to
those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, including exhibits to those
reports, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Our
websites and the information contained therein or incorporated therein are not intended to be incorporated into this
Annual Report on Form 10-K. The SEC maintains a website that contains reports, proxy and information statements, and
other information regarding reports that we file or furnish electronically with them at www.sec.gov.
ITEM 1A. RISK FACTORS
The risks and uncertainties described below may have a material adverse effect on our business, prospects,
financial condition or operating results. In addition, we may be adversely affected by risks that we currently deem
immaterial or by other risks that are not currently known to us. You should carefully consider these risks before making
an investment decision. The trading price of our common stock could decline due to any of these risks and you may lose
all or part of your investment. In assessing the risks described below, you should also refer to the other information
contained in this Annual Report on Form 10-K.
Risks Related to Our Products, Programs and Operations
Our ability to achieve profitability is highly dependent on the commercial success of OMIDRIA, and to the extent
OMIDRIA is not successful, our business, financial condition and results of operations may be materially
adversely affected and the price of our common stock may decline.
OMIDRIA is our only product that has been approved by the Food and Drug Administration (“FDA”), for
commercial sale in the U.S. For the three and 12 months ended December 31, 2019, we recorded net sales of OMIDRIA
of $33.4 million and $111.8 million, respectively. Revenues from sales of OMIDRIA have not been sufficient to fund
our operations fully in prior periods and we cannot provide assurance that revenues from OMIDRIA sales will be
sufficient to fund our operations fully in the future. We will need to generate substantially more product revenue from
OMIDRIA to achieve and sustain profitability. We may be unable to sustain or increase revenues generated from
OMIDRIA product sales for a number of reasons, including:
•
the scheduled expiration of pass-through reimbursement on September 30, 2020 and uncertainty regarding the
extent of coverage and reimbursement for OMIDRIA when used in Medicare patients after September 30, 2020;
29
•
•
•
•
•
•
pricing, coverage and reimbursement policies of government and private payers such as Medicare, Medicaid,
the U.S. Department of Veterans Affairs, group purchasing organizations, insurance companies, health
maintenance organizations and other plan administrators;
a lack of acceptance by physicians, patients and other members of the healthcare community;
the availability, relative price and efficacy of the product as compared to alternative treatment options or
branded, compounded or generic competing products;
an unknown safety risk;
the failure to enter into and maintain acceptable partnering arrangements for marketing and distribution of
OMIDRIA outside of the U.S.; and
changed or increased regulatory restrictions in the U.S., EU and/or other foreign territories.
If legislative and/or administrative means to extend separate payment for OMIDRIA are not successful, we would
need to pursue an alternative sales strategy, and our revenues and financial condition could be adversely and
significantly affected.
Pass-through reimbursement status allows for separate payment (i.e., outside the packaged payment rate for the
surgical procedure) under Medicare Part B. Under the Consolidated Appropriations Act of 2018 (the “2018
Appropriations Act”), Congress extended pass-through reimbursement status for a small number of drugs, including
OMIDRIA, used during procedures performed on Medicare Part B fee-for-service patients for an additional two years,
running from October 1, 2018 through September 30, 2020. We continue to seek permanent separate or similar
reimbursement for OMIDRIA. However, this requires action from legislative and/or administrative authorities and we
cannot guarantee that any such action will be taken or, if taken, when such action will be effective. On November 1,
2019, in its 2020 OPPS final rule, CMS declined to grant separate payment to OMIDRIA beyond the current expiration
of its pass-through status on September 30, 2020. CMS also noted in the 2020 final rule that it would continue to analyze
evidence and monitor utilization of OMIDRIA. Accordingly, we can provide no assurances that separate reimbursement
for OMIDRIA will continue to be available on or after September 30, 2020, or if available, that the reimbursement rate
will be adequate. If the future reimbursement status of OMIDRIA continues to be uncertain as the scheduled date for
expiration of pass-through status approaches, then demand for OMIDRIA from ambulatory surgery centers (“ASCs”)
and hospitals may be reduced substantially. In such event, sales to our wholesalers may decrease correspondingly, as
they adjust on-hand inventory in anticipation of reduced demand from end users.
If we are unable to obtain permanent separate or similar reimbursement for OMIDRIA, we expect to pursue an
alternative sales strategy. We may face difficulties or delays in implementing an alternative sales strategy and, even if
successfully implemented, we cannot predict how quickly, or if, our customers would increase their OMIDRIA
utilization, and the net revenues we receive for OMIDRIA could be reduced, potentially by a significant amount. A
reduction in OMIDRIA revenues for this or any other reason may also impair our ability to borrow under our line of
credit facility with Silicon Valley Bank (“SVB”).
Any of these risks, if realized, would adversely affect our ability to generate revenue and attain profitability, and
there would be a material adverse effect on our business, financial condition, results of operations and growth prospects
and the trading price of our stock could decline.
30
If OMIDRIA or any other product that we develop and commercialize does not receive adequate coverage or
reimbursement from governments and/or private payers, or if we do not establish and maintain market-
acceptable pricing for OMIDRIA or those potential other commercialized products, our prospects for revenue
and profitability would suffer.
Our revenues depend heavily on the pricing, availability and duration of adequate coverage or reimbursement for
the use of products that we or our third-party business partners commercialize, including OMIDRIA, from government,
private and other third-party payers, both in the U.S. and in other countries. Any product that we bring to market may not
be considered cost-effective and/or the amount reimbursed for any product may be insufficient to allow us to sell the
product profitably. Obtaining coverage and adequate reimbursement for any product from each government or third-
party payer can be a time-consuming and costly process that may require expansion of staff and/or increased use of third
parties and could require us to provide additional supporting scientific, clinical and cost-effectiveness data for the use of
our approved products to each payer. We can provide no assurances at this time regarding the cost-effectiveness of
OMIDRIA or any of our product candidates. Further, we can provide no assurance that the amounts, if any, reimbursed
to surgical facilities for utilization of any of our surgery-related products, including OMIDRIA or any of our product
candidates, or to surgeons for the administration and delivery of these products or product candidates will be considered
adequate to justify the use of these products or product candidates. The Trump administration has proposed increasing
CMS’ power to negotiate with drug makers and possibly set reimbursement based on an index of international prices,
and a proposed rule by CMS would, if implemented, empower Part D sponsors and Medicare Advantage plan to use
prior authorization and step therapy more aggressively, each of which could adversely impact pricing of our products,
including OMIDRIA. We also can provide no assurance that Merit-Based Incentive Payment System payment
adjustments for eligible professionals under the Medicare Access and CHIP Reauthorization Act of 2015 will not
adversely impact OMIDRIA sales revenue.
There may be significant delays in obtaining coverage or reimbursement for newly approved products, and we may
not be able to provide data sufficient to be granted adequate coverage or reimbursement. Even when a payer determines
that a product is eligible for reimbursement, coverage may be limited to the uses of a product that are either approved by
the FDA (or, in other countries, the relevant country’s regulatory agency) and/or appear in a recognized drug
compendium, or other conditions may apply. Moreover, eligibility for coverage does not mean that any product will be
reimbursed at a rate that allows us to make a profit in all cases or at a rate that covers our costs, including research,
development, manufacturing, sales and distribution. Increasingly, government and private third-party payers that
reimburse for healthcare services and products are requiring that companies provide them with predetermined discounts
from list prices and are challenging the prices charged for medical products, which could adversely impact the pricing of
our products. Any reduction in reimbursement from Medicare or other government programs may result in a similar
reduction in payments from private payers. Pricing may also be adversely affected by changes in the terms, scope and/or
complexity of government pricing requirements. Even if we achieve coverage or reimbursement for a product, the initial
rate or method at which the product will be reimbursed could become unfavorable to us at the time reimbursement is
initiated or in the future or may be of a limited duration. In addition, obtaining acceptable coverage and reimbursement
from one payer does not guarantee that we will obtain similar acceptable coverage or reimbursement from another payer.
In non-U.S. jurisdictions, we must obtain separate reimbursement approvals and comply with related foreign legal
and regulatory requirements. In some countries, including those in the EU, our products may be subject to government
price controls. Pricing negotiations with governmental authorities can take a considerable amount of time and
expenditure of resources after the receipt of marketing approval for a product. We provide no assurances that the price of
any product in one or more of these countries or regions will allow us to make a profit or cover our costs, including
research, development, manufacturing, sales and distribution, and as a result we may decide to delay, potentially
indefinitely, initiating sales in the particular country or region.
If the reimbursement or pricing that we are able to obtain and maintain for any product that we develop and
commercialize, including OMIDRIA, is inadequate, is significantly delayed or is subject to overly restrictive conditions,
our ability to generate revenue, attain profitability and/or commercialize our product candidates may be impaired and
there could be a material adverse effect on our business, financial condition, results of operations and growth prospects
and the trading price of our stock could decline.
31
Our operating results are unpredictable and may fluctuate.
Our operating results are difficult to predict and will likely fluctuate from quarter to quarter and year to year. We
believe that our quarterly and annual results of operations may be affected by a variety of factors, including:
•
•
•
•
•
the level and timing of commercial sales of OMIDRIA, as well as our product candidates if and when approved
or commercialized;
the extent of coverage and reimbursement for OMIDRIA;
the amount of OMIDRIA chargebacks, rebates and product returns;
the extent of any payments received from collaboration arrangements and development funding as well as the
achievement of development and clinical milestones under collaboration and license agreements that we may
enter into from time to time and that may vary significantly from quarter to quarter; and
the timing, cost and level of investment in our research and development activities as well as expenditures we
will or may incur to acquire or develop additional technologies, products and product candidates, or in
preparation for potential commercialization of our product candidates.
In addition, the number of procedures in which OMIDRIA or any of our product candidates, if commercialized,
would be used may be significantly less than the total number of such procedures performed or total possible market
size. These and other factors, including our limited history of product sales since the reinstatement of pass-through
reimbursement for OMIDRIA, make it difficult for us to forecast and provide accurate guidance (including updates to
prior guidance) related to our expected financial performance. If our operating results are below the expectations of
securities analysts or investors, the trading price of our stock could decline.
We have incurred cumulative operating losses since inception. If we are unable to raise additional capital when
needed, our commercial operations may be limited and we may be unable to complete the development and
commercialization of our product candidates or to continue our other preclinical development programs.
Our operations have consumed substantial amounts of cash since our incorporation and, as of December 31, 2019,
we had an accumulated deficit of approximately $734.6 million. We expect to continue to spend substantial amounts to:
•
•
•
initiate and conduct clinical trials and manufacture clinical and registration batches for our programs and
product candidates;
continue OMIDRIA sales and marketing;
continue research and development in our programs;
• make principal, interest and fee payments as required under our 6.25% Convertible Senior Notes due 2023 (the
“Convertible Notes”); and
•
commercialize and launch product candidates for which we may receive regulatory approval.
We expect to continue to incur additional losses until such time as we generate significant revenue from the sale of
OMIDRIA, other commercial products or partnerships. We are unable to predict the extent of any future losses and
cannot provide assurance that we will generate sufficient revenue from OMIDRIA or other commercial products in the
future to fund our operations fully. If we are unable to generate sufficient revenue from the sale of OMIDRIA, other
commercialized products or partnership arrangements, we may never become and remain profitable and will be required
to raise additional capital to continue to fund our operations. We cannot be certain that additional capital will be
available to us on acceptable terms, if at all, when required. Adverse developments to our financial condition or
32
business, as well as disruptions in the global equity and credit markets, may limit our ability to access capital. If we do
not raise additional capital when needed through one or more funding avenues, such as debt or equity financings or
corporate partnering, we may have to significantly delay, scale back or discontinue the development or
commercialization of one or more of our product candidates or one or more of our preclinical programs or other research
and development initiatives. In addition, we may be required to seek collaborators for one or more of our current or
future products at an earlier stage than otherwise would be desirable or on terms that are less favorable than otherwise
might be available or to relinquish or license on unfavorable terms our rights to technologies or products that we
otherwise would seek to develop or commercialize ourselves. We also may have insufficient funds or otherwise be
unable to advance our preclinical programs, such as potential new drug targets developed from our GPCR program, to a
point where they can generate revenue through partnerships, collaborations or other arrangements. Any of these actions
could limit the amount of revenue we are able to generate and harm our business and prospects.
Management, as well as our independent registered public accounting firm, have concluded that a substantial
doubt is deemed to exist concerning our ability to continue as a going concern.
As further discussed in Part II, Item 8, “Note 1--Organization and Basis of Presentation” to our Consolidated
Financial Statements in this Annual Report on Form 10-K, substantial doubt is deemed to exist about the company’s
ability to continue as a going concern through March 2, 2021. Our financial statements do not include any adjustment
relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities
that might be necessary should we be unable to continue as a going concern. Our ability to continue as a going
concern will require us to generate positive cash flow from operations, obtain additional financing, enter into strategic
alliances and/or sell assets. Our limited cash resources and our potential inability to continue as a going concern may
materially adversely affect our share price and our ability to raise new capital, enter into strategic alliances and/or make
our scheduled debt payments on a timely basis or at all. If we become unable to continue as a going concern, we may
have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly
lower than the values reflected in our financial statements.
We are subject to extensive government regulation and the failure to comply with these regulations may have a
material adverse effect on our operations and business.
Both before and after approval of any product, we and our suppliers, contract manufacturers and clinical
investigators are subject to extensive regulation by governmental authorities in the U.S. and other countries, covering,
among other things, testing, manufacturing, quality control, clinical trials, post-marketing studies, risk management
plans, labeling, advertising, promotion, distribution, import and export, governmental pricing, price reporting and rebate
requirements. Failure to comply with applicable requirements could result in one or more of the following actions:
warning letters; unanticipated expenditures; delays in approval or refusal to approve a product candidate; product recall
or seizure; interruption of manufacturing or clinical trials; operating or marketing restrictions; injunctions; criminal
prosecution and civil or criminal penalties including fines and other monetary penalties; adverse publicity; and
disruptions to our business. Further, government investigations into potential violations of these laws would require us to
expend considerable resources and face adverse publicity and the potential disruption of our business even if we are
ultimately found not to have committed a violation.
Obtaining FDA approval of our product candidates requires substantial time, effort and financial resources and may
be subject to both expected and unforeseen delays, and there can be no assurance that any approval will be granted on
any of our product candidates on a timely basis, if at all. Even if we discuss with, and obtain feedback from, the FDA
regarding our proposed clinical trials, clinical data collection protocols and nonclinical studies before initiating those
trials or studies, the FDA may decide that the design of our clinical trials or clinical data collection protocols as actually
run, or our resulting data, are insufficient for approval of our product candidates and may require us to run additional
preclinical, clinical or other studies or perform additional work related to chemistry, manufacturing and controls. In
addition, we, the FDA or an independent institutional review board or ethics committee may suspend or terminate human
clinical trials at any time on various grounds, including a finding that the patients are or would be exposed to an
unacceptable health risk or because of the way in which the investigators on whom we rely carry out the trials. If we are
required to conduct additional trials or to conduct other testing of our product candidates beyond that which we currently
contemplate for regulatory approval, if we are unable to complete our clinical trials or other testing successfully, or if the
33
results of these and other trials or tests fail to demonstrate efficacy or raise safety concerns, we may face substantial
additional expenses, be delayed in obtaining marketing approval for our product candidates or may never obtain
marketing approval.
We are also required to comply with extensive governmental regulatory requirements after a product has received
marketing authorization. Governing regulatory authorities may require post-marketing studies that may negatively
impact the commercial viability of a product. Once on the market, a product may become associated with previously
undetected adverse effects and/or may develop manufacturing difficulties. We are required to comply with other post-
marketing requirements including current Good Manufacturing Practices, advertising and promotion restrictions,
pharmacovigilance requirements including risk management activities, reporting and recordkeeping obligations, and
other requirements. As a result of any of these or other problems, a product’s regulatory approval could be withdrawn,
which could harm our business and operating results. In addition, we must maintain an effective healthcare compliance
program in order to comply with U.S. and other laws applicable to marketed drug products and, in particular, laws (such
as the Anti-Kickback Statute, the False Claims Act and the Sunshine Act) applicable when drug products are purchased
or reimbursed by a federal or state healthcare program. U.S. laws such as the Foreign Corrupt Practices Act prohibit the
offering or payment of bribes or inducements to foreign public officials, including potentially physicians or other
medical professionals who are employees of public health care entities in jurisdictions outside the U.S. In addition, many
countries have their own laws similar to the healthcare compliance laws that exist in the U.S. Implementing and
maintaining an effective compliance program requires the expenditure of significant time and resources. If we are found
to be in violation of any of these laws, we may be subject to significant penalties, including but not limited to civil or
criminal penalties, damages and fines as well as exclusion from government healthcare programs.
We may face difficulties from changes to current regulations as well as future legislation.
Existing regulatory policies may change and additional government regulations may be enacted that could prevent,
limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of
government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. 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, we may lose any marketing approval that we may have obtained and we
may not achieve or sustain profitability.
There is uncertainty with respect to the impact that health care reform legislation may have on coverage and
reimbursement for healthcare items and services covered by plans that are authorized by the 2010 Affordable Care Act
(“ACA”). President Trump and various members of Congress have expressed a desire to repeal all or portions of the
ACA and, in December 2017, portions of the ACA dealing with the individual mandate insurance requirement were
effectively repealed by the Tax Cuts and Jobs Act of 2017. Congress and/or President Trump may seek to repeal other
aspects of the ACA. In December 2018, a federal district court judge in Texas found the ACA’s individual mandate to be
unconstitutional and therefore the entire law to be invalid. In December 2019, the Fifth Circuit affirmed the ruling
regarding the individual mandate but remanded the case to the district court for additional analysis of the question of
severability and whether portions of the law remain valid. The case has been appealed to the Supreme Court and on
March 2, 2020, the Supreme Court announced that it would hear oral argument during its next term. President Trump,
the Secretary of Health and Human Services, various members of Congress and CMS have made statements and/or
issued proposals regarding containment of drug prices through various means, including measures designed to enable
CMS greater power to negotiate U.S. drug pricing and/or set reimbursement based on an index of international drug
prices, pricing transparency measures, and reforms that would empower Part D sponsors and Medicare Advantage plans
to more aggressively use prior authorization and step therapy as a means to control prescription drug costs. We cannot
predict the ultimate content, timing or effect of any healthcare reform legislation, rulemaking or executive order, or the
impact that the resulting changes may have on us.
We expect that the ACA, if it remains in effect, as well as other healthcare reform measures that may be adopted in
the future, may result in more rigorous coverage criteria and apply downward pressure on the price that we receive for
any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a
similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare
reforms may prevent us from being able to generate sufficient revenue, attain and/or maintain profitability or
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commercialize our product candidates. We cannot be sure whether additional legislative changes will be enacted, or
whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on OMIDRIA
or the marketing approvals of our product candidates, if any, may be.
Failure to obtain and maintain regulatory approval in foreign jurisdictions would prevent us from marketing our
products internationally.
We intend to have OMIDRIA and our product candidates, if approved, marketed outside the U.S. In order to market
our products in non-U.S. jurisdictions, we or our partners must obtain separate regulatory approvals and comply with
numerous and varying regulatory requirements. The regulatory approval procedure varies among countries and can
involve additional testing and data review. The requirements governing marketing authorization, the conduct of clinical
trials, pricing and reimbursement vary from country to country. Approval by the FDA does not ensure approval by the
European Medicines Agency (“EMA”), and approval by one foreign regulatory authority does not ensure approval by
regulatory agencies in other foreign countries or by the FDA. The time required to obtain regulatory approval outside the
U.S. and EU may differ from that required to obtain FDA or EU approval. The foreign regulatory approval process may
include all of the risks associated with obtaining FDA approval discussed in these “Risk Factors” and we may not obtain
foreign regulatory approvals on a timely basis, or at all. In addition, even if we were able to obtain regulatory approval
for a product in one or more foreign jurisdictions, we may need to complete additional requirements to maintain that
approval and our ability to market the product in the applicable jurisdiction.
We may face a variety of risks associated with international operations that, if realized, could materially
adversely affect our business.
We may be subject to additional risks for OMIDRIA or any of our product candidates that are marketed outside the
U.S., including:
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reduced protection for intellectual property rights;
unexpected changes in tariffs, trade barriers and regulatory requirements, including those associated with the
withdrawal of the United Kingdom from the EU;
economic weakness, including inflation, or political instability in particular foreign economies and markets;
foreign currency fluctuations and other obligations incident to doing business in another country; and
business interruptions resulting from geopolitical actions, including war and terrorism, adverse public health
developments such as the outbreak of the COVID-19 coronavirus, or natural disasters including earthquakes,
typhoons, floods and fires.
Any of these risks, if realized, could increase our operating expenses and reduce our revenues.
We have no internal capacity to manufacture commercial or clinical supplies of OMIDRIA or our product
candidates and intend to rely solely on third-party manufacturers. If the contract manufacturers that we rely on
experience difficulties manufacturing and supplying OMIDRIA or our product candidates, or fail FDA or other
regulatory inspections, our clinical trials, regulatory submissions and ability to sell OMIDRIA or any other
commercialized product and generate revenue may be significantly limited or delayed.
We rely and intend to continue to rely on third-party manufacturers to produce commercial quantities of OMIDRIA
and clinical drug supplies of our product candidates that are needed for clinical trials and to support NDAs, BLAs, or
similar applications to regulatory authorities seeking marketing approval for our product candidates, as well as to
produce inventory of our product candidates in anticipation of potential commercialization. We cannot provide any
assurance that we will be able to enter into or maintain these types of arrangements on commercially reasonable terms,
or at all. If we or the manufacturer were to terminate one of these arrangements early, or the manufacturer was unable to
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supply product quantities sufficient to meet our requirements, we would be required to transfer manufacturing to an
approved alternative facility and/or establish additional manufacturing and supply arrangements. We may also need to
establish additional or replacement manufacturers, potentially with little or no notice, in the event that one of our
manufacturers fails to comply with FDA and/or other pharmaceutical manufacturing regulatory requirements. Even if we
are able to establish additional or replacement manufacturers, identifying these sources and entering into definitive
supply agreements and obtaining regulatory approvals may require a substantial amount of time and cost and may create
a shortage of the product. It can take several years to qualify and validate a new contract manufacturer, and we cannot
guarantee that we would be able to complete in a successful and timely manner the appropriate validation processes or
obtain the necessary regulatory approvals for one or more additional or replacement manufacturers. Such alternate
supply arrangements may not be available on commercially reasonable terms, or at all. Additionally, if we are unable to
engage multiple suppliers to manufacture our products, we may have inadequate supply to meet demand for our product.
In addition, narsoplimab is a biologic drug product and any other product candidate from certain of our programs,
including but not limited to MASP-2 and MASP-3, could be a biologic drug product. We do not have the internal
capability to produce biologics for use in clinical trials or on a commercial scale. There are only a limited number of
manufacturers of biologic drug products and we may be unable to enter into agreements on commercially reasonable
terms with a sufficient number of them to meet clinical or commercial demand, if at all. The regulatory requirements for
commercial supply are more stringent than for clinical supply and we cannot guarantee that a contract manufacturer
producing drug product for clinical trials will be able to complete in a successful and timely manner the appropriate
validation processes or obtain the necessary regulatory approvals for marketing approval and commercial supply in a
timely manner or at all.
Our contract manufacturers may encounter difficulties with formulation, manufacturing, supply chain and/or release
processes that could result in delays in clinical trials and/or regulatory submissions or that could impact adversely the
commercialization of our products or product candidates, as well as in the initiation of enforcement actions by the FDA
and other regulatory authorities. These difficulties also could result in the recall or withdrawal of a product from the
market or a failure to have adequate supplies to meet market demand. If the safety or manufacturing quality of
OMIDRIA or any product candidate supplied by contract manufacturers is compromised due to one or more of those
contract manufacturers’ failure to adhere to applicable laws or for other reasons, we may not be able to maintain
regulatory approval of OMIDRIA, to continue sales and marketing of OMIDRIA, to run clinical trials or to obtain and
maintain regulatory approval for one or more of our product candidates, which would harm our business and prospects
significantly.
Any significant delays in the manufacture and/or supply of clinical or commercial supplies could materially harm
our business, financial condition, results of operations and prospects.
Ingredients, excipients, test kits and other materials necessary to manufacture OMIDRIA or our product
candidates may not be available on commercially reasonable terms, or at all, which may adversely affect the sales
of OMIDRIA or development and commercialization of our product candidates.
We and our third-party manufacturers must obtain from third-party suppliers the APIs, excipients, and/or other raw
materials plus primary and secondary packaging materials necessary for our contract manufacturers to produce
OMIDRIA and our product candidates for our clinical trials and, to the extent approved or commercialized, for
commercial distribution. Although we have entered or intend to enter into agreements with third-party suppliers that will
guarantee the availability and timely delivery of APIs, excipients, test kits and materials for OMIDRIA and our product
candidates, we have not yet entered into agreements for the supply of all such ingredients, excipients, test kits or
materials, and we may be unable to secure all such supply agreements or guarantees on commercially reasonable terms,
if at all. Even if we were able to secure such agreements or guarantees, our suppliers may be unable or choose not to
provide us the ingredients, excipients, test kits or materials in a timely manner or in the quantities required. If we or our
third-party manufacturers are unable to obtain the quantities of these ingredients, excipients or materials that are
necessary for the manufacture of commercial supplies of OMIDRIA, our ability to generate revenue from the sale of
OMIDRIA would be materially and adversely affected. Further, if we or our third-party manufacturers are unable to
obtain APIs, excipients, test kits and materials as necessary for our clinical trials or for the manufacture of commercial
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supplies of our product candidates, if approved, potential regulatory approval or commercialization would be delayed,
which would materially and adversely affect our ability to generate revenue from the sale of our product candidates.
If our clinical trials or clinical protocols are delayed, suspended or terminated, we may be unable to develop our
product candidates on a timely basis, which would adversely affect our ability to obtain regulatory approvals,
increase our development costs and delay or prevent commercialization of approved products.
We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials
or clinical data collection protocols that will cause regulatory agencies, institutional review boards or ethics committees,
or us to delay our clinical trials or suspend or delay the analysis of the data from those trials. Clinical trials and clinical
data protocols can be delayed for a variety of reasons, including:
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discussions with the FDA, the EMA or other foreign authorities regarding the scope or design of our clinical
trials or clinical data collection protocols;
delays or the inability to obtain required approvals from institutional review boards, ethics committees or other
responsible entities at clinical sites selected for participation in our clinical trials;
delays in enrolling patients into clinical trials, collecting data from enrolled patients or collecting historical
control data for any reason including disease severity, trial or data collection protocol design, study eligibility
criteria, patient population size (e.g., for orphan diseases or for some pediatric indications), proximity and/or
availability of clinical trial sites for prospective patients, availability of competing therapies and clinical trials,
regional differences in diagnosis and treatment, perceived risks and benefits of the product or product
candidate, physician patient referral practices, disruptions due to external events, including an outbreak of
pandemic or contagious disease such as the COVID-19 coronavirus, which as described above has caused an
enrollment delay in the small cohort of our Phase 2 clinical trial of narsoplimab in patients with IgA
nephropathy that is being conducted exclusively at sites in Hong Kong and focuses on subcutaneous dosing and
associated biomarkers, or the ability to monitor patients adequately before and after treatment;
lower than anticipated retention rates of patients in clinical trials;
the need to repeat or conduct additional clinical trials as a result of inconclusive or negative results, failure to
replicate positive early clinical data in subsequent clinical trials, failure to deliver an efficacious dose of a
product candidate, poorly executed testing, a failure of a clinical site to adhere to the clinical protocol, an
unacceptable study design or other problems;
adverse findings in clinical or nonclinical studies related to the safety of our product candidates in humans;
an insufficient supply of product candidate materials or other materials necessary to conduct our clinical trials;
the need to qualify new suppliers of product candidate materials for FDA and foreign regulatory approval;
an unfavorable inspection or review by the FDA or other regulatory authority of a clinical trial site or records of
any clinical investigation;
the occurrence of unacceptable drug-related side effects or adverse events experienced by participants in our
clinical trials;
the suspension by a regulatory agency of a trial by imposing a clinical hold; or
the amendment of clinical trial or data collection protocols to reflect changes in regulatory requirements and
guidance or other reasons as well as subsequent re-examination of amendments to clinical trial or data
collection protocols by institutional review boards or ethics committees.
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In addition, our clinical trial or development programs have been, and in the future may be, suspended or terminated
by us, the FDA or other regulatory authorities, or institutional review boards or ethics committees due to a number of
factors, including:
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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the
imposition of a clinical hold;
the failure to remove a clinical hold in a timely manner, if at all;
unforeseen safety issues or any determination that a trial presents unacceptable health risks;
inability to deliver an efficacious dose of a product candidate; or
lack of adequate funding to continue the clinical trial or development program, including as a result of
unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and/or
increased expenses associated with the services of our contract research organizations (“CROs”), or other third-
parties.
If the results of our clinical trials are not available when we expect or if we encounter any delay in the analysis of
data from our clinical trials, we may be unable to file for regulatory approval or conduct additional clinical trials on the
schedule we currently anticipate. Many of the factors that cause, or lead to, a delay in the commencement or completion
of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Any delays in
completing our clinical trials could increase our development costs, could slow down our product development and
regulatory submission process, could delay our receipt of product revenue and could make it difficult to raise additional
capital. In addition, significant clinical trial delays also could allow our competitors to bring products to market before
we do and impair our ability to commercialize our future products, potentially harming our business.
Because we have a number of product candidates and development programs, we may expend our limited
resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or
indications for which there is a greater likelihood of obtaining regulatory approval and that may be more
profitable, if approved.
We have limited resources and must focus on the product candidates and clinical and preclinical development
programs that we believe are the most promising. As a result, we may forgo or delay the pursuit of opportunities with
other product candidates or other indications that later prove to have greater commercial potential and may not be able to
progress development programs as rapidly as otherwise possible. Further, if we do not accurately evaluate the
commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that
product through collaboration, license or other royalty arrangements in cases in which it would have been advantageous
for us to retain sole development and commercialization rights.
Our product candidates may not successfully complete clinical development or be suitable for successful
commercialization or generation of revenue through partnerships, and our preclinical programs may not produce
product candidates that are suitable for clinical trials.
We must successfully complete preclinical testing, which may include demonstrating efficacy and the lack of
toxicity in established animal models, before commencing clinical trials for any product candidate. Many pharmaceutical
and biological product candidates do not successfully complete preclinical testing. There can be no assurance that
positive results from preclinical studies will be predictive of results obtained from subsequent preclinical studies or
clinical trials. Even if preclinical testing is successfully completed, we cannot be certain that any product candidates that
do advance into clinical trials will successfully demonstrate safety and efficacy in clinical trials. Even if we achieve
positive results in early clinical trials, they may not be predictive of the results in later trials, and safety and/or efficacy
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outcomes of early clinical trials may not be consistent with outcomes of subsequent clinical trials. There can be no
assurance that we will be able to successfully commercialize our current or future product candidates or to meet our
expectations with respect to revenues or profits from such products.
We may incur substantial costs as a result of commercial disputes, claims, litigation or other legal proceedings
relating to our business operations, especially with regard to patent and other intellectual property rights, and
such costs or an adverse outcome in such a proceeding may adversely affect our financial condition, results of
operations and/or stock price.
Our business involves numerous commercial contractual arrangements, important intellectual property rights,
potential product liability, uncertainties with respect to clinical development, manufacture and regulatory approvals and
other aspects that create heightened risks of disputes, claims and legal proceedings. These include claims that may be
faced in one or more jurisdictions related to the safety of our product candidates and products, the development of our
product candidates, our ability to obtain regulatory approval for our product candidates, our expectations regarding
product development and regulatory approval, sales and marketing practices, commercial disputes including with
contract manufacturers, competition, environmental matters, employment matters and other matters. These matters could
consume significant time and resources, even if we are successful. Many of our competitors and contractual
counterparties are significantly larger than we are and, as a result, may be able to sustain the costs of complex litigation
more effectively than we can because they have substantially greater resources. In addition, we may pay damage awards
or settlements or become subject to equitable remedies that could, individually or in the aggregate, have a material
negative effect on our financial condition, results of operations or stock price. Any uncertainties resulting from the
initiation and continuation of any litigation also could have a material adverse effect on our ability to raise the capital
necessary to continue our operations.
We may initiate or become subject to litigation regarding patents and other intellectual property rights. Patent
infringement litigation involves many complex technical and legal issues and its outcome is often difficult to predict and
the risk involved in doing so can be substantial. Generic drug manufacturers could seek approval to market a generic
version of our products or challenge our intellectual property rights with respect to our product candidates.
If we choose to go to court or take other action to enforce our intellectual property rights, we may become subject to
claims that our underlying patents are invalid or should not be enforced against that third-party. These lawsuits are
expensive and would consume time and other resources even if we were successful in stopping the infringement of our
patents. In addition, a lawsuit could result in a finding that some or all of the claims of one or more of our relevant
patents are invalid, unenforceable and/or not infringed, and could result in a generic version of any of our products being
launched prior to the expiration of our related patents. There is also the risk that, even if the validity of these patents is
upheld, a court will refuse to stop the other party on the ground that such other party’s activities do not infringe our
patents.
It may not be feasible to detect and undertake patent enforcement action to stop infringing activity by a number of
individual entities, each on a small scale, such as compounding pharmacies. Further, our industry has produced a large
number of patents and it is not always clear which patents cover various types of products or methods of use. A third
party may claim that we or our contract manufacturers are using inventions covered by the third party’s patent rights and
may go to court to stop us from engaging in the alleged infringing activity, including making, using or selling our
products and product candidates. These lawsuits are costly and could affect our results of operations and divert the
attention of managerial and technical personnel. There is a risk that a court would decide that we, or our contract
manufacturers, are infringing the third party’s patents and would order us or our contractors to stop the activities covered
by the patents. In addition, if we or our contract manufacturers are found to have violated a third party’s patent, we or
our contract manufacturers could be ordered to pay damages to the other party. We have agreed to or may agree to
indemnify our contract manufacturers against certain patent infringement claims and thus may be responsible for any of
their costs associated with such claims and actions. If we were sued for patent infringement, we would need to
demonstrate that our products and product candidates or methods of use either do not infringe the patent claims of the
relevant patent or that the patent claims are invalid, and we might be unable to do this. Proving invalidity, in particular,
is difficult since it requires clear and convincing evidence to overcome the presumption of validity enjoyed by issued
patents.
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It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be
able to ensure their protection.
Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret
protection for the use, formulation and structure of our products and product candidates, the methods used to
manufacture them, the related therapeutic targets and associated methods of treatment as well as on successfully
defending these patents against potential third-party challenges. Our ability to protect our products and product
candidates from unauthorized making, using, selling, offering to sell or importing by third parties is dependent on the
extent to which we have rights under valid and enforceable patents that cover these activities.
The patent positions of pharmaceutical, biotechnology and other life sciences companies can be highly uncertain
and involve complex legal and factual questions for which important legal principles remain unresolved. Changes in
either the patent laws or in interpretations of patent laws in the U.S. and other countries may diminish the value of our
intellectual property. Further, the determination that a patent application or patent claim meets all of the requirements for
patentability is a subjective determination based on the application of law and jurisprudence. The ultimate determination
by the USPTO or by a court or other trier of fact in the U.S., or corresponding foreign national patent offices or courts,
on whether a claim meets all requirements of patentability cannot be assured. Although we have conducted searches for
third-party publications, patents and other information that may affect the patentability of claims in our various patent
applications and patents, we cannot be certain that all relevant information has been identified. Accordingly, we cannot
predict the breadth of claims that may be allowed or enforced in our patents or patent applications, in our licensed
patents or patent applications or in third-party patents.
We cannot provide assurances that any of our patent applications will be found to be patentable, including over our
own prior art patents, or will issue as patents. Neither can we make assurances as to the scope of any claims that may
issue from our pending and future patent applications nor to the outcome of any proceedings by any potential third
parties that could challenge the patentability, validity or enforceability of our patents and patent applications in the U.S.
or foreign jurisdictions. Any such challenge, if successful, could limit patent protection for our products and product
candidates and/or materially harm our business.
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 or permit us to gain or keep our competitive advantage. For
example:
• we may not be able to generate sufficient data to support full patent applications that protect the entire breadth
of developments in one or more of our programs or platforms;
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it is possible that one or more of our pending patent applications will not become an issued patent or, if issued,
that the patent(s) will be sufficient to protect our technology, provide us with a basis for commercially viable
products or provide us with any competitive advantages;
if our pending applications issue as patents, they may be challenged by third parties as not infringed, invalid or
unenforceable under U.S. or foreign laws; or
if issued, the patents under which we hold rights may not be valid or enforceable.
In addition, to the extent that we are unable to obtain and maintain patent protection for one of our products or
product candidates or in the event that such patent protection expires or is limited to method of use patent protection, it
may no longer be cost-effective to extend our portfolio by pursuing additional development of a product or product
candidate for follow-on indications.
We also may rely on trade secrets to protect our technologies or products, especially where we do not believe patent
protection is appropriate or obtainable. However, trade secrets are difficult to protect. Although we use reasonable
efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaborators and other
advisers may unintentionally or willfully disclose our information to competitors. Enforcing a claim that a third-party
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entity illegally obtained and is using any of our trade secrets is expensive and time-consuming, and the outcome is
unpredictable. In addition, courts outside the U.S. are sometimes less willing to protect trade secrets. Moreover, our
competitors may independently develop equivalent knowledge, methods and know-how.
Our indebtedness and liabilities could limit the cash flow available for our operations and expose us to risks that
could adversely affect our business, financial condition and results of operations.
In November 2018 we issued $210.0 million aggregate principal amount of our Convertible Notes, and as of
December 31, 2019 we had approximately $2.8 million of outstanding finance lease obligations. We may incur
additional indebtedness to meet future financing needs. Our indebtedness could have significant negative consequences
for our security holders and our business, results of operations and financial condition by, among other things:
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increasing our vulnerability to adverse economic and industry conditions;
limiting our ability to obtain additional financing;
requiring a substantial portion of our cash flow from operations to service our indebtedness, which will reduce
the amount of cash available for other purposes;
limiting our flexibility to plan for, or react to, changes in our business;
diluting the interests of our existing stockholders as a result of issuing shares of our common stock upon
conversion of the Convertible Notes; and
placing us at a possible competitive disadvantage with competitors that are less leveraged than we are or have
better access to capital.
Our ability to make scheduled payments of the principal of, to pay interest on, or to refinance our indebtedness,
including the Convertible Notes, depends on our future performance, which is subject to many factors, including,
economic, financial, competitive and other circumstances beyond our control. Our business may not generate sufficient
funds, and we may otherwise be unable to maintain sufficient cash reserves, to pay amounts due under our indebtedness,
including the Convertible Notes, and our cash needs may increase in the future. In addition, future indebtedness that we
may incur may contain, financial and other restrictive covenants that limit our ability to operate our business, raise
capital or make payments under our other indebtedness. If we fail to comply with these covenants or to make payments
under our indebtedness when due, then we would be in default under that indebtedness, which could, in turn, result in
that and our other indebtedness becoming immediately payable in full.
Our competitors may develop products that are less expensive, safer or more effective, or which may otherwise
diminish or eliminate the success of any products that we may commercialize.
We may not achieve commercial success if our competitors, many of whom have significantly more resources and
experience than we, market products that are safer, more effective, less expensive or faster to reach the market than any
products that we may develop and commercialize. Our competitors also may market a product that proves to be unsafe
or ineffective, which may affect the market for our competing product, or future product, regardless of the safety or
efficacy of our product. The failure of OMIDRIA or any future product that we may market to compete effectively with
products marketed by our competitors would impair our ability to generate revenue, which would have a material
adverse effect on our future business, our financial condition and our results of operations.
The loss of members of our management team could substantially disrupt our business operations.
Our success depends to a significant degree on the continued individual and collective contributions of our
management team. The members of our management team are at-will employees, and we do not maintain any key-
person life insurance policies other than on the life of Gregory A. Demopulos, M.D., our president, chief executive
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officer and chairman of the board of directors. Losing the services of any key member of our management team, whether
from death or disability, retirement, competing offers or other causes, without having a readily available and appropriate
replacement could delay the execution of our business strategy, cause us to lose a strategic partner, or otherwise
materially affect our operations.
We rely on highly skilled personnel and, if we are unable to retain or motivate key personnel or hire qualified
personnel, we may not be able to maintain our operations or grow effectively.
Our performance is largely dependent on the talents and efforts of highly skilled individuals. Our future success
depends on our continuing ability to identify, hire, develop, motivate and retain highly skilled personnel for all areas of
our organization. If we are unable to hire and train a sufficient number of qualified employees for any reason, we may
not be able to implement our current initiatives or grow effectively. We maintain a rigorous, highly selective and time-
consuming hiring process. We believe that our approach to hiring has significantly contributed to our success to date. If
we do not succeed in attracting qualified personnel and retaining and motivating existing personnel, our existing
operations may suffer and we may be unable to grow effectively.
We may encounter difficulties managing our growth, which could delay our business plans or adversely affect our
results of operations.
To manage our future growth, we must continue to implement and improve our managerial, operational and
financial systems and continue to recruit and train additional qualified personnel. Due to our limited financial resources,
we may not be able to manage effectively the expansion of our operations or recruit and train additional qualified
personnel. The physical expansion of our operations may lead to significant costs and may divert our management and
business development resources. Any inability to manage growth could delay the execution of our business plans or
disrupt our operations. Additionally, our inability to manage growth effectively could cause our operating costs to grow
even faster than we currently are anticipating.
Our credit facility contains restrictive covenants that may limit our operating flexibility.
In August 2019, we entered into a loan and security agreement with SVB, under which we may borrow up to the
lesser of $50.0 million and 85.0% of our eligible accounts receivable, less certain reserves. The credit facility contains
restrictive covenants that limit our ability to transfer or dispose of assets, merge with other companies or consummate
certain changes of control, acquire other companies, incur additional indebtedness and liens and enter into new
businesses. We therefore may not be able to engage in any of the foregoing transactions unless we obtain the consent of
the lender or terminate the credit facility, which may limit our operating flexibility. In addition, our credit facility is
secured by all of our assets, excluding our intellectual property and development program inventories. While we had no
outstanding borrowings under the credit facility and were in compliance with all covenants as of December 31, 2019,
there is no guarantee that we will be able to generate sufficient cash flow or revenue to meet these financial covenants or
pay the principal and interest on any future borrowings under our facility.
Product liability claims may damage our reputation and, if insurance proves inadequate, these claims may harm
our business.
We may be exposed to the risk of product liability claims that is inherent in the biopharmaceutical industry. A
product liability claim may damage our reputation by raising questions about our product’s safety and efficacy and could
limit our ability to sell one or more products by preventing or interfering with commercialization of our products and
product candidates. In addition, product liability insurance for the biopharmaceutical industry is generally expensive to
the extent it is available at all. There can be no assurance that we will be able to obtain or maintain such insurance on
acceptable terms or that we will be able to secure and maintain increased coverage for OMIDRIA or for our product
candidates, if commercialization progresses, or that future claims against us will be covered by our product liability
insurance. Further, our product liability insurance coverage may not reimburse us or may be insufficient to reimburse us
for any or all expenses or losses we may suffer. A successful claim against us with respect to uninsured liabilities or in
excess of insurance coverage could have a material adverse effect on our business, financial condition and results of
operations.
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We rely on third parties to conduct portions of our preclinical research and clinical trials. If these third parties do
not perform as contractually required or otherwise expected, or if we fail to adequately supervise or monitor
these parties, we may not be able to obtain regulatory approval for or commercialize our product candidates.
We rely on third parties, such as CROs, medical and research institutions and clinical investigators, to conduct a
portion of our preclinical research and assist us in conducting our clinical trials. Nonetheless, we are responsible for
confirming that our preclinical research and clinical trials are conducted in accordance with applicable regulations, the
relevant trial protocol and within the context of approvals by an institutional review board or ethics committee, and we
may not always be successful in ensuring such compliance. Our reliance on these third parties does not relieve us of
responsibility for ensuring compliance with FDA and other regulations and standards for conducting, monitoring,
recording and reporting the results of preclinical research and clinical trials to assure that data and reported results are
credible and accurate and that the trial participants are adequately protected. If these third parties do not successfully
carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be
replaced or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our clinical
protocols or regulatory requirements or for other reasons, our preclinical and clinical development processes may be
extended, delayed, suspended or terminated, and we may not be able to commercialize or obtain regulatory approval for
our product candidates.
We may need to maintain licenses for active ingredients from third parties to develop and commercialize some of
our product candidates, which could increase our development costs and delay our ability to commercialize those
product candidates.
Should we decide to use APIs in any of our product candidates that are proprietary to one or more third parties, such
as our PDE7 program (OMS527), we would need to maintain licenses to those active ingredients from those third
parties. If we are unable to continue to access rights to these active ingredients prior to conducting preclinical toxicology
studies intended to support clinical trials, we may need to develop alternate product candidates from these programs by
either accessing or developing alternate active ingredients, resulting in increased development costs and delays in
commercialization of these product candidates. If we are unable to maintain continued access rights to the desired active
ingredients on commercially reasonable terms or develop suitable alternate active ingredients, or if we do not meet
diligence or other obligations under the corresponding licenses, we may not be able to commercialize product candidates
from these programs.
We use hazardous materials in our business and must comply with environmental laws and regulations, which
can be expensive.
Our research operations produce hazardous waste products, which include chemicals and radioactive and biological
materials. We are subject to a variety of federal, state and local regulations relating to the use, handling, storage and
disposal of these materials. Although we believe that our safety procedures for handling and disposing of these materials
comply with applicable legal regulations, the risk of accidental contamination or injury from these materials cannot be
eliminated. We generally contract with third parties for the disposal of such substances and store our low-level
radioactive waste at our facility until the materials are no longer considered radioactive. We may be required to incur
further costs to comply with current or future environmental and safety regulations. In addition, although we carry
insurance, in the event of accidental contamination or injury from these materials, we could be held liable for any
damages that result and any such liability could exceed our insurance coverage and other resources.
Cyber-attacks or other failures in telecommunications or information technology systems could result in
information theft, data corruption and significant disruption of our business operations.
We utilize information technology systems and networks to process, transmit and store electronic information in
connection with our business activities. As use of digital technologies has increased, cyber incidents, including
deliberate attacks and attempts to gain unauthorized access to computer systems and networks, have increased in
frequency and sophistication. These threats pose a risk to the security of our systems and networks, the confidentiality
and the availability and integrity of our data. There can be no assurance that we will be successful in preventing cyber-
attacks or mitigating their effects. Similarly, there can be no assurance that our collaborators, CROs, third-party logistics
43
providers, distributors and other contractors and consultants will be successful in protecting our clinical and other data
that is stored on their systems. Any cyber-attack or destruction or loss of data could have a material adverse effect on our
business and prospects. In addition, we may suffer reputational harm or face litigation or adverse regulatory action as a
result of cyber-attacks or other data security breaches and may incur significant additional expense to implement further
data protection measures.
Risks Related to Our Common Stock
Our stock price has been and may continue to be volatile, and the value of an investment in our common stock
may decline.
During the 12-month period ended December 31, 2019, our stock traded as high as $20.92 per share and as low as
$10.88 per share. The trading price of our common stock is likely to continue to be highly volatile and could be subject
to wide fluctuations in response to numerous factors, many of which are beyond our control. In addition, the stock
market has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the
operating performance of publicly traded companies. Broad market and industry factors may seriously affect the market
price of companies’ stock, including ours, regardless of actual operating performance. These fluctuations may be even
more pronounced in the trading market for our stock. In addition, in the past, following periods of volatility in the overall
market and the market price of a particular company’s securities, securities class action litigation has often been
instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion
of our management’s attention and resources.
If we issue additional shares of our common stock or other securities that may be convertible into, or exercisable
or exchangeable for, our common stock, our existing shareholders would experience further dilution.
To the extent that we raise additional funds in the future by issuing equity securities, our shareholders would
experience dilution, which may be significant and could cause the market price of our common stock to decline
significantly. In addition, approximately 11.5 million shares of common stock were subject to outstanding options and
warrants as of December 31, 2019 and may become eligible for sale in the public market to the extent permitted by the
provisions of various vesting agreements. As of December 31, 2019, we also had approximately 5.4 million shares of
common stock reserved for future issuance under our employee benefit plans that are not subject to outstanding options.
Further, to the extent we issue common stock upon conversion of the Convertible Notes, such conversion would dilute
the ownership interests of existing stockholders despite the expected reduction of such dilution as a result of the capped
call transaction that we entered into in connection with issuance of the Convertible Notes. If the holders of outstanding
options or warrants elect to exercise some or all of them, or if the shares subject to our employee benefit plans are issued
and become eligible for sale in the public market, or we issue common stock upon conversion of the Convertible Notes,
our shareholders would experience dilution and the market price of our common stock could decline.
Anti-takeover provisions in our charter documents and under Washington law could make an acquisition of us,
which may be beneficial to our shareholders, difficult and prevent attempts by our shareholders to replace or
remove our current management.
Provisions in our articles of incorporation and bylaws and under Washington law may delay or prevent an
acquisition of us or a change in our management. These provisions include a classified board of directors, a prohibition
on shareholder actions by less than unanimous written consent, restrictions on the ability of shareholders to fill board
vacancies and the ability of our board of directors to issue preferred stock without shareholder approval. In addition,
because we are incorporated in Washington, we are governed by the provisions of Chapter 23B.19 of the Washington
Business Corporation Act, which, among other things, restricts the ability of shareholders owning 10% or more of our
outstanding voting stock from merging or combining with us. Although we believe these provisions collectively provide
for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our board of directors, they
would apply even if an offer may be considered beneficial by some shareholders. In addition, these provisions may
frustrate or prevent any attempts by our shareholders to replace or remove our current management by making it difficult
for shareholders to replace members of our board of directors, which is responsible for appointing the members of our
management.
44
We have never declared or paid dividends on our capital stock, and we do not anticipate paying dividends in the
foreseeable future.
Our business requires significant funding. We currently plan to invest all available funds and future earnings, if any,
in the development and growth of our business. Additionally, under the loan and security agreement with SVB, we have
agreed not to pay any dividends. Therefore, we currently do not anticipate paying any cash dividends on our common
stock in the foreseeable future. As a result, a rise in the market price of our common stock, which is uncertain and
unpredictable, will be the sole source of potential gain for shareholders in the foreseeable future, and an investment in
our common stock for dividend income should not be relied upon.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
We lease approximately 110,308 square feet for our principal office and laboratory space in the building located at
201 Elliott Avenue West, Seattle, Washington (“The Omeros Building”), which includes approximately 5,436 square
feet of laboratory space that we are subleasing to third parties. The lease term for our space is through November 2027.
We also have two options to extend the lease term, each by five years. The annual base rent due under the lease for our
principal office and laboratory space is $6.4 million for 2020, $6.5 million for 2021 and $6.7 million for 2022 and will
increase by approximately 2.3% each year thereafter. In addition, we are responsible for paying our proportionate share
of the building’s utilities, taxes, insurance and maintenance as well as a property management fee.
We believe that our facilities are sufficient for our anticipated near-term needs.
ITEM 3. LEGAL PROCEEDINGS
From time to time, in the ordinary course of business, we may be involved in various claims, lawsuits and other
proceedings. As of the date of filing of this Annual Report on Form 10-K, we were not involved in any material legal
proceedings.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
45
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
PART II
Market Information
Our common stock is traded on The Nasdaq Global Market under the symbol “OMER.”
Holders
As of February 24, 2020, there were approximately 99 holders of record of our common stock.
Dividends
We have never declared or paid any cash dividends on our capital stock. We expect to retain all available funds and
future earnings to fund the development and growth of our business and we do not anticipate paying any cash dividends
in the foreseeable future.
Recent Sales of Unregistered Securities
We did not sell any equity securities during the fiscal year ended December 31, 2019 in transactions that were not
registered under the Securities Act.
Stock Performance Graph
The following graph compares the cumulative total shareholder return for our common stock (OMER), the Nasdaq
Biotechnology Index (NBI) and the Nasdaq U.S. Benchmark TR Index (NQUSBT) for the period beginning
December 31, 2014 and ending December 31, 2019. This graph assumes that $100 was invested on December 31, 2014
in our common stock, the Nasdaq Biotechnology Index and the Nasdaq U.S. Benchmark TR Index. It also assumes that
46
any dividends were reinvested. The data shown in the following graph are not necessarily indicative of future stock price
performance.
Comparison of 5 Year Cumulative Return
Assumes Initial Investment of $100
OMER
NBI
NQUSBT
$200
$100
$0
12/31/14
12/31/15
12/31/16
12/31/17
12/31/18
12/31/19
The foregoing information shall not be deemed to be “soliciting material” or to be “filed” for purposes of Section 18
of the Exchange Act or otherwise subject to liability under that Section. In addition, the foregoing information shall not
be deemed to be incorporated by reference into any of our filings under the Exchange Act or the Securities Act of 1933,
except to the extent that we specifically incorporate this information by reference.
ITEM 6. SELECTED CONSOLIDATED FINANCIAL DATA
The following selected consolidated financial data should be read in conjunction with “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the
47
accompanying notes included elsewhere in this Annual Report on Form 10-K. Our historical results are not necessarily
indicative of the results to be expected in any future period.
Consolidated Statements of Operations
and Comprehensive Loss Data:
Revenues:
2019
Year Ended December 31,
2017
(In thousands, except per share and share data)
2016
2018
2015
Product sales, net . . . . . . . . . . . . . . . . . . . . $
111,805 $
29,868 $
64,826 $
41,617 $
13,509
Costs and expenses:
Cost of product sales . . . . . . . . . . . . . . . .
Research and development . . . . . . . . . . .
Selling, general and administrative . . . . .
Total costs and expenses . . . . . . . . . . . .
Loss from operations . . . . . . . . . . . . . . . . . . .
Loss on early extinguishment of debt . . . . .
Interest expense . . . . . . . . . . . . . . . . . . . . . . .
Other income . . . . . . . . . . . . . . . . . . . . . . . . .
Loss before income taxes . . . . . . . . . . . . . . .
Income tax benefit . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Comprehensive loss . . . . . . . . . . . . . . . . . . . $
Basic and diluted net loss per share . . . . . . . $
Weighted-average shares used to compute
865
109,696
64,626
175,187
(63,382)
—
(22,657)
1,553
(84,486)
—
(84,486) $
(84,486) $
(1.71) $
512
89,860
51,718
142,090
(112,222)
(12,993)
(16,252)
1,781
(139,686)
12,929
(126,757) $
(126,757) $
(2.61) $
1,078
55,599
52,044
108,721
(43,895)
—
(11,030)
1,444
(53,481)
—
(53,481) $
(53,481) $
(1.17) $
1,412
50,699
43,782
95,893
(54,276)
(5,595)
(7,819)
945
(66,745)
—
(66,745) $
(66,745) $
(1.65) $
1,041
48,379
35,327
84,747
(71,238)
(1,315)
(3,573)
1,030
(75,096)
—
(75,096)
(75,096)
(2.00)
basic and diluted net loss per share . . . . . . 49,523,444 48,582,636 45,539,362 40,446,410 37,560,257
2019
2018
2017
2016
2015
As of December 31,
(In thousands)
Consolidated Balance Sheet Data:
Cash, cash equivalents and short-term
investments . . . . . . . . . . . . . . . . . . . . . . . . . $
Working capital . . . . . . . . . . . . . . . . . . . . . . .
Restricted investments . . . . . . . . . . . . . . . . .
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . .
Note payable . . . . . . . . . . . . . . . . . . . . . . . . .
Lease liabilities (1) . . . . . . . . . . . . . . . . . . . .
Unsecured convertible senior notes, net . . .
Accumulated deficit . . . . . . . . . . . . . . . . . . .
Total shareholders’ deficit . . . . . . . . . . . . . .
60,788 $
48,286
1,154
136,969
—
35,822
158,213
(734,611)
(109,021)
60,498 $
52,511
1,154
95,936
—
2,467
148,981
(650,125)
(100,156)
83,749 $
82,065
5,835
116,328
83,307
1,300
—
(523,368)
(2,814)
45,331 $
44,191
5,835
67,278
79,187
523
—
(469,887)
(37,447)
28,263
20,893
10,679
48,995
49,842
—
—
(403,142)
(26,234)
(1) We adopted ASU 2016-02, Leases, (Topic 842) on January 1, 2019 using a modified retrospective approach. For
additional information regarding our lease adoption, see Part II, Item 8, “Note 2--Significant Accounting Policies”
to our Consolidated Financial Statements in this Annual Report on Form 10-K.
48
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with the audited annual consolidated financial
statements and the related notes thereto included elsewhere in this Annual Report on Form 10-K. This discussion
contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. Actual
results may differ materially from those discussed in these forward-looking statements due to a number of factors,
including those set forth in the section entitled “Risk Factors” and elsewhere in this Annual Report on Form 10-K. For
further information regarding forward-looking statements, please refer to the special note regarding forward-looking
statements at the beginning of this Annual Report on Form 10-K. Throughout this discussion, unless the context specifies
or implies otherwise, the terms “Company,” “we,” “us” and “our” refer to Omeros Corporation and our wholly owned
subsidiaries.
Overview
We are a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing
small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation,
complement-mediated diseases, disorders of the central nervous system, and immune-related diseases, including cancers.
Our drug product OMIDRIA® is marketed in the United States for use during cataract surgery or intraocular lens
(“IOL”), replacement procedures to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to
reduce postoperative ocular pain. In our pipeline we have multiple Phase 3 and Phase 2 clinical-stage development
programs focused on complement-associated thrombotic microangiopathies; complement-mediated disorders and
substance abuse. In addition, we have a diverse group of preclinical programs, including GPR174, a novel target in
immuno-oncology that modulates a new cancer immunity axis recently discovered by us. Small-molecule inhibitors of
GPR174 are part of our proprietary G protein-coupled receptor (“GPCR”), platform through which we control 54 new
GPCR drug targets and their corresponding compounds. We also exclusively possess a novel antibody-generating
platform. For OMIDRIA and each of our product candidates and our programs, we have retained control of all
commercial rights.
Financial Summary
We recognized net losses of $84.5 million, $126.8 million, and $53.5 million for the years ended December 31,
2019, 2018 and 2017, respectively and our OMIDRIA revenues were $111.8 million, $29.9 million, and $64.8 million
respectively. During the period from January 1, 2018 to September 30, 2018, OMIDRIA was not reimbursed separately
when used for procedures involving patients covered by Medicare Part B.
* Fiscal quarters without pass-through reimbursement.
49
Separate reimbursement payment for OMIDRIA was restored for a two-year period effective October 1, 2018. On
November 1, 2019, the Centers for Medicare Services (“CMS”), declined to grant separate payment to OMIDRIA
beyond the expiration of its current pass-through status on September 30, 2020. CMS also noted in the 2020 final rule
that it would continue to analyze evidence and monitor utilization of OMIDRIA. If we are unable to obtain permanent
separate or similar reimbursement for OMIDRIA, the net revenues we receive for OMIDRIA would be reduced,
potentially by a significant amount. Although we expect to pursue an alternative sales strategy if we are unable to obtain
permanent separate or similar reimbursement for OMIDRIA, we may face difficulties or delays in implementing such a
strategy and, even if successfully implemented, we cannot predict whether or to what extent our customers would
increase their utilization of OMIDRIA. See Part 1, Item 1, “Business-Commercial Product -- OMIDRIA” for additional
details regarding the pass-through reimbursement status for OMIDRIA.
We expect our net losses will continue until such time as we derive sufficient revenues from sales of OMIDRIA
and/or other sources, such as licensing, product sales and other revenues from our product candidates, that are sufficient
to cover our operating expenses and debt service obligations.
As of December 31, 2019, we had $60.8 million in cash and cash equivalents and short-term investments available
for general corporate use and $35.2 million in accounts receivable, net.
Results of Operations
Revenue
Our revenue consists of OMIDRIA product sales to ambulatory surgery centers (“ASCs”), and hospitals in the U.S.
Our product sales, net are as follows:
Product sales, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
111,805
2019
Year Ended December 31,
2018
(In thousands)
29,868
$
$
2017
64,826
We launched OMIDRIA in the U.S. in the second quarter of 2015 and sell OMIDRIA primarily through wholesalers
which, in turn, sell to ASCs and hospitals. CMS, the federal agency responsible for administering the Medicare program,
granted transitional pass-through reimbursement status for OMIDRIA, effective from January 1, 2015 through
December 31, 2017. Pass-through status for OMIDRIA allows for separate reimbursement payment (i.e., outside the
packaged procedural payment) to ASCs and hospitals using OMIDRIA in procedures involving patients covered by
Medicare Part B.
During the nine-month period from January 1, 2018 to September 30, 2018, OMIDRIA was not reimbursed
separately when used for procedures involving patients covered by Medicare Part B. The 2018 Appropriations Act
extended pass-through reimbursement status for certain drugs, including OMIDRIA, for a two-year period beginning
October 1, 2018 through September 30, 2020.
In 2019, OMIDRIA revenue increased $81.9 million, or 274%, as compared to the year ended December 31, 2018.
The increase in revenue in 2019 compared to 2018 was due to significantly increased demand for OMIDRIA by ASCs
and hospitals following the reinstatement of pass-through reimbursement status for OMIDRIA on October 1, 2018.
In 2018, OMIDRIA revenue decreased $35.0 million, or 53.9%, as compared to the year ended December 31, 2017.
The decrease in OMIDRIA revenue in 2018 was attributable to the lack of separate reimbursement payments for
OMIDRIA for procedures involving patients covered under Medicare Part B from January 1, 2018 through
September 30, 2018.
We believe that a substantial majority of facilities that are using OMIDRIA will continue to use OMIDRIA at
current or greater rates during the period OMIDRIA is eligible for pass-through reimbursement. Accordingly, we
anticipate that OMIDRIA product sales, net, will continue to increase at least through the first half of 2020 compared to
50
the same period in 2019. We continue to pursue administrative and legislative means to obtain continued separate
payment or similar reimbursement status for OMIDRIA; however, we are currently unable to predict when separate or
similar reimbursement will be granted, if at all, and what the actual reimbursement rate for OMIDRIA will be. If our
administrative and legislative efforts are unsuccessful, we expect to pursue an alternative sales strategy. After
implementing this strategy, we cannot predict how quickly, or if, our customers would increase their OMIDRIA
utilization.
Gross-to-Net Deductions
We record OMIDRIA product sales net of estimated chargebacks, rebates, distribution fees and product returns.
These deductions are generally referred to as gross-to-net deductions. Our total gross-to-net provisions for the years
ended December 31, 2019, 2018 and 2017 were 27.7%, 28.1% and 27.8%, respectively, of gross OMIDRIA product
sales.
Our gross-to-net provision and payments for the years ended December 31, 2019, 2018 and 2017 are summarized
below:
Distribution
Chargebacks
and Rebates
Fees and
Product
Return
Allowances
(In thousands)
Balance as of December 31, 2016 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance as of December 31, 2017 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance as of December 31, 2018 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance as of December 31, 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
1,629 $
19,188
(15,093)
5,724
10,341
(9,050)
7,015
37,232
(34,007)
10,240 $
481 $
5,741
(2,849)
3,373
1,309
(3,197)
1,485
5,387
(4,635)
2,237 $
Chargebacks and Rebates
Total
2,110
24,929
(17,942)
9,097
11,650
(12,247)
8,500
42,619
(38,642)
12,477
We record a provision for estimated chargebacks and rebates at the time we recognize OMIDRIA product sales
revenue and reduce the accrual when payments are made or credits are granted. Our chargebacks are related to a
pharmaceutical pricing agreement, a Federal supply schedule agreement, a 340B prime vendor agreement, a Medicaid
drug rebate agreement and beginning in 2019, an off-invoice discount to our ASC and hospital customers. We also
record a provision for our OMIDRIAssure® patient assistance and reimbursement services program and our rebates
under our purchase volume-discount programs.
Distribution Fees and Product Return Allowances
We pay our wholesalers a distribution fee for services they perform for us based on the dollar value of their
purchases of OMIDRIA. We record a provision for these charges as a reduction to revenue at the time of sale to the
wholesaler and make payments to our wholesalers based on contractual terms.
We allow for the return of product up to 12 months past its expiration date, or for product that is damaged or not
used by our customers. We record a provision for returns upon sale of OMIDRIA to our wholesaler. When a return or
claim is received, we issue a credit memo to the wholesaler against its outstanding receivable to us or we reimburse the
customer.
51
We accept returns from our wholesalers and ASCs and hospitals that have purchased OMIDRIA. Should pass-
through reimbursement expire on September 30, 2020, it is possible that wholesalers, ASCs and hospitals may return a
portion of their OMIDRIA on hand for a full refund of the purchase price. If a reserve is required, we would record the
reserve during our third quarter of 2020.
Research and Development Expenses
Our research and development expenses can be divided into three categories: direct external expenses, which
include clinical research and development and preclinical research and development activities; internal, overhead and
other expenses; and stock-based compensation expense. Direct external expenses consist primarily of expenses incurred
pursuant to agreements with third-party manufacturing organizations prior to receiving regulatory approval for a product
candidate, contract research organizations (“CROs”), clinical trial sites, collaborators, and licensors and consultants.
Costs are reported in preclinical research and development until the program enters the clinic. Internal, overhead and
other expenses consist of personnel costs, overhead costs such as rent, utilities and depreciation and other miscellaneous
costs. We do not generally allocate our internal resources, employees and infrastructure to any individual research
project because we deploy them across multiple clinical and preclinical projects that we are advancing in parallel.
The following table illustrates our expenses associated with these activities:
Year Ended
December 31,
2018
2019
2017
Direct external expenses:
Clinical research and development:
MASP-2 Program - OMS721 (narsoplimab) . . . . . . . . . . . . . . . . . . . . . $
OMIDRIA - Ophthalmology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PDE7 - OMS527 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total clinical research and development . . . . . . . . . . . . . . . . . . . . .
Preclinical research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total direct external expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Internal, overhead and other expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total research and development expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 109,696 $
49,804 $
2,679
4,066
56,549
14,410
70,959
32,642
6,095
46,383
2,388
3,586
52,357
6,465
58,822
26,077
4,961
89,860
$
$
19,557
3,458
—
23,015
5,983
28,998
21,361
5,240
55,599
The $12.1 million, or 20.6%, increase in direct external expenses for the year ended December 31, 2019 as
compared to the year ended December 31, 2018 was due primarily to higher third-party narsoplimab process validation
and commercial drug substance manufacturing costs in 2019 compared to the earlier-stage manufacturing scale-up costs
incurred in 2018 and higher clinical study costs. The increase in direct external expenses related to our preclinical
research and development expense in 2019 compared to 2018 reflects the increase in third-party manufacturing scale-up
costs related to our OMS906 program, offset by costs associated with the initiation of a Phase 1 clinical trial for
OMS527, our PDE7 program for addiction and compulsive disorders in July 2018.
The $29.8 million, or 102.8%, increase in direct external expenses for the year ended December 31, 2018 as
compared to the year ended December 31, 2017 was due primarily to higher early stage third-party manufacturing scale-
up costs for our narsoplimab program as we continued to increase our production capacity, higher clinical costs
associated with initiating our narsoplimab IgA nephropathy Phase 3 clinical trial and the initiation, in July 2018, of our
Phase 1 clinical trial for OMS527. In addition, we also incurred higher third-party preclinical development expenses as
we advanced OMS527 into the clinic and continued preclinical development of our small-molecule MASP-2 inhibitors,
OMS906 and our GPCR programs. These increases were partially offset by decreased costs due to completing the
transfer of OMIDRIA manufacturing to a new facility in December 2017.
52
The increases in internal, overhead and other expenses in all years presented are primarily due to due to additional
employee-related costs and buildout of additional laboratory facilities in 2019 to support our increased research and
development activities.
During 2020, we expect that the majority of our research and development expenses will be related to narsoplimab.
We expect research and development costs to increase in 2020 as we continue our ongoing Phase 3 clinical programs
and manufacture commercial drug substance in preparation for our anticipated submission of marketing applications and
potential commercialization of narsoplimab in HSCT-TMA in the U.S. and Europe.
At this time, we are unable to estimate with any certainty the longer-term costs we will incur in the continued
development of our product candidates due to the inherently unpredictable nature of our preclinical and clinical
development activities. Clinical development timelines, the probability of success and development costs can differ
materially as new data become available and as expectations change. Our future research and development expenses will
depend, in part, on the preclinical or clinical success of each product candidate as well as ongoing assessments of each
program’s commercial potential. In addition, we cannot forecast with precision which product candidates, if any, may be
subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements
would affect our development plans and capital requirements.
We are required to expend substantial resources in the development of our product candidates due to the lengthy
process of completing clinical trials and seeking regulatory approval. Any failure or delay in completing clinical trials, or
in obtaining regulatory approvals, could delay our generation of product revenue and increase our research and
development expenses, which, in turn, could have a material adverse effect on our results of operations, financial
condition and liquidity. Because of the factors above, we are not able to estimate with any certainty when or if we would
recognize any net cash inflows from our research and development projects.
Selling, General and Administrative Expenses
Our selling, general and administrative expenses are comprised primarily of salaries, benefits and stock-
compensation costs for sales, marketing and other personnel not directly engaged in research and development,
marketing and selling expenses, professional and legal services, general corporate costs and an allocation of our
occupancy costs.
2019
Year Ended December 31,
2018
(In thousands)
2017
Selling, general and administrative expenses, excluding stock-based
compensation expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Stock-based compensation expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total selling, general and administrative expenses . . . . . . . . . . . . . . . . . . $
56,936 $
7,690
64,626 $
44,966 $
6,752
51,718 $
44,596
7,448
52,044
The increase in selling, general and administrative expenses, excluding stock-based compensation during the year
ended December 31, 2019 was primarily due to increased pre-commercialization activities for narsoplimab, sales and
marketing costs related to OMIDRIA subsequent to obtaining reinstatement of pass-through reimbursement in
October 2018, consulting and professional service fees, and employee-related costs.
The increase in selling, general and administrative expenses, excluding stock-based compensation during the year
ended December 31, 2018 as compared to 2017 was primarily due to increased fees related to patent applications,
consulting and professional service fees, and headcount-related costs, partially offset by reduced legal costs associated
with pursuing patent infringement claims against generic drug manufacturers that sought to obtain FDA approval for a
generic version of OMIDRIA, which were favorably resolved. (See Part I, Item 1, “Business-License and Development
Agreements” for more information regarding the successful conclusion of our patent infringement lawsuits.)
53
We expect that our selling, general and administrative expenses for 2020 will increase from 2019, primarily due to
preparations for potential commercialization of narsoplimab in HSCT-TMA including incremental sales related
headcount supporting pre-commercial activities.
Interest Expense
2019
Year Ended December 31,
2018
(In thousands)
2017
Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
22,657 $
16,252 $
11,030
The increase in interest expense over the years 2019, 2018 and 2017 is primarily due the issuance, in
November 2018, of $210.0 million of 6.25% Convertible Senior Notes due 2023 (the “Convertible Notes”), which
replaced $125.0 million of previously outstanding debt. Non-cash interest expense for 2019, 2018 and 2017 was
$9.2 million, $5.6 million and $4.2 million, respectively. For more information regarding our debt and our Convertible
Notes, see Part II, Item 8, “Note 7--Debt” and “Note 8--Convertible Senior Notes” to our Consolidated Financial
Statements in this Annual Report on Form 10-K.
We expect interest expense will remain consistent in 2020.
Loss on Early Extinguishment of Debt
Loss on early extinguishment of debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
— $
12,993 $
—
In November 2018, we issued Convertible Notes and repaid all previously outstanding loan amounts. We incurred a
loss on early extinguishment of debt of $13.0 million associated with the unamortized lender facility fee, debt issuance
costs, debt discount and prepayment fees in connection with the repayment.
2019
Year Ended December 31,
2018
(In thousands)
2017
Other Income
2019
Year Ended December 31,
2018
(In thousands)
2017
Other Income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
1,553 $
1,781 $
1,444
Other income principally includes sublease rental income and interest earned on our cash and investments. The
variations between years is primarily due to the amounts of cash and investments we have available to invest.
Financial Condition - Liquidity and Capital Resources
As of December 31, 2019, we had $60.8 million in cash, cash equivalents and short-term investments available for
general corporate use held primarily in money-market accounts as compared to $60.5 million at December 31, 2018. In
addition, as of December 31, 2019 we had $35.2 million in accounts receivable, net.
In December 2019, we issued 4,389,311 shares of common stock in an offering that was registered under the
Securities Act and received approximately $54.2 million of net proceeds, after deducting the underwriter’s discount and
our offering expenses.
In August 2019, we entered into a Loan and Security Agreement with Silicon Valley Bank, which provides for a
$50.0 million revolving line of credit facility, or the Line of Credit Agreement. Under the Line of Credit Agreement, we
may draw, on a revolving basis, up to the lesser of $50.0 million and 85.0% of our eligible accounts receivable, less
certain reserves. We have no outstanding borrowings under the Line of Credit Agreement. For more information
54
regarding the Line of Credit Agreement, see Part II, Item 8, “Note 7--Debt” to our Consolidated Financial Statements in
this Annual Report on Form 10-K.
In November 2018, we issued $210.0 million of Convertible Notes. We used $146.0 million of the proceeds to repay
a previously outstanding loan, including associated prepayment fees and accrued interest, and $33.2 million to enter into
the Capped Call Transaction described below, resulting in net proceeds available for corporate use, after deducting the
initial purchasers’ discounts and commissions and our offering expenses, of $24.0 million. For more information
regarding the Convertible Notes, see Part II, Item 8, “Note 8--Convertible Senior Notes” to our Consolidated Financial
Statements in this Annual Report on Form 10-K.
We have historically generated net losses and incurred negative cash flows. For the year ended December 31, 2019,
we incurred net losses of $84.5 million and incurred negative cash flows from operations of $60.1 million.
We cannot predict future OMIDRIA revenues in the second half of 2020 and beyond due to the uncertain
reimbursement status of OMIDRIA after the currently scheduled expiration of pass-through reimbursement on
September 30, 2020. See Part 1, Item 1, “Business-Commercial Product – OMIDRIA” for additional details regarding
the pass-through reimbursement status for OMIDRIA. Similarly, we are unable to include in the determination regarding
our prospects as a going concern amounts available under the Line of Credit Agreement, as borrowing availability is
determined based on eligible OMIDRIA accounts receivable. We have also not included any proceeds from debt
transactions or other financing instruments, despite our successful track record in accessing capital through each of these
avenues nor any potential partnerships related to our products or product candidates. The conditions described above
when evaluated within the constraints of the accounting literature raise substantial doubt with respect to our ability to
meet our obligations through March 2, 2021 and, therefore, to continue as a going concern.
We plan to continue to fund our operations through proceeds from sales of OMIDRIA and, in addition, we may
utilize funds available under our receivable-based line of credit. Should it be necessary or determined to be strategically
advantageous, we also could pursue debt financings, public and private offerings of our equity securities similar to those
we have completed previously, and/or other strategic transactions, which may include licensing a portion of our existing
technology. If these capital sources, for any reason, are needed but inaccessible, it would have a significantly negative
effect on our financial condition. Should it be necessary to manage our operating expenses, we would reduce our
projected cash requirements through reduction of our expenses by delaying clinical trials, reducing selected research and
development efforts, and/or implementing other restructuring activities.
The accompanying consolidated financial statements have been prepared on a going-concern basis, which
contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The
accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on
the recoverability and classification of assets or the amounts and classification of liabilities that may result from
uncertainty related to our ability to continue as a going concern.
Cash Flow Data
Selected cash flow data
Cash provided by (used in):
2019
Year ended December 31,
2018
(In thousands)
2017
Operating activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (60,073) $ (103,737) $ (36,227)
(37,598)
Investing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
74,995
Financing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
(3,401) $
60,697 $
25,151
81,053
Operating Activities. Net cash used in operating activities decreased for the year ended December 31, 2019 by
$43.7 million as compared to the same period in 2018. The decrease largely resulted from the $42.3 million decrease in
our net loss from 2018 due to an increase in OMIDRIA product sales of $81.9 million, partially offset by a $33.1 million
increase in total cost and expenses. In addition, increases in non-cash charges of $6.1 million in 2019 compared to 2018
55
also positively impacted the change in our cash used in operating activities. The net change in operating assets and
liabilities of $5.1 million also reduced our net cash used in operations for the year ended December 31, 2019 compared
to the same period in 2018.
Net cash used in operating activities increased for the year ended December 31, 2018 by $67.5 million as compared
to 2017. The increase largely resulted from the $73.3 million increase in our net loss from 2017 due to a decrease in
OMIDRIA product sales of $35.0 million and an increase in research and development expense of $34.3 million. In
addition, increases in changes in operating assets and liabilities of $4.1 million and non-cash charges of $1.3 million in
2018 when compared to 2017 positively impacted the change in our cash used in operating activities.
Investing Activities. Cash flows from investing activities primarily reflect cash used to purchase short-term
investments and proceeds from the sale of short-term investments, thus causing a shift between our cash and cash
equivalents and short-term investment balances. Because we manage our cash usage with respect to our cash, cash
equivalents and short-term investments, we do not consider the fluctuations in cash flows from investing activities to be
important to the understanding of our liquidity and capital resources.
Net cash used investing activities during 2019 was $3.4 million, a decrease of $28.6 million from the $25.2 million
net cash provided by investing activities for the same period in 2018. The net change in our investments sold compared
to purchased decreased by $28.8 million providing cash to fund our operations.
Net cash provided by investing activities in the year ended December 31, 2018 was $25.2 million, an increase of
$62.7 million from the $37.6 million used in investing activities in 2017. The cash provided by investing activities in
2018 was primarily due to proceeds from the sale of short-term investments for $94.5 million, which were partially
offset by the sale and maturity of $68.8 million of short-term investments.
Financing Activities. Net cash provided by financing activities in the year ended December 31, 2019 was
$60.7 million, a net decrease of $20.4 million over the same period in 2018, In December 2019, we sold 4.4 million
shares of our common stock at a public offering price of $15.24 per share. After deducting underwriter discounts and
offering expense, we received net proceeds from the transaction of $54.2 million.
Net cash provided by financing activities in the year ended December 31, 2018 was $81.1 million, a net increase of
$6.1 million over 2017 and included the following: $24.0 million of net proceeds from the issuance of Convertible Notes
(see Convertible Notes immediately following); $44.6 million in net proceeds from borrowings under our now
extinguished note payable without a similar borrowing in 2017; $6.7 million in proceeds from exercises of stock options
compared to $11.8 million in 2017; $63.7 million in proceeds from issuance of common stock in 2017 without a similar
issuance in 2018; and $4.7 million in funds made available in 2018 due to a decrease in restricted investments.
Convertible Notes
For more information regarding the Convertible Notes, see Part II, Item 8, “Note 8--Convertible Senior Notes” to
our Consolidated Financial Statements in this Annual Report on Form 10-K.
Line of Credit
On August 2, 2019, we entered into the Line of Credit Agreement, under which we may draw, on a revolving basis,
up to the lesser of $50.0 million and 85.0% of our eligible accounts receivable, less certain reserves. The Line of Credit
Agreement is secured by all our assets excluding intellectual property and development program inventories and matures
on August 2, 2022. As of December 31, 2019, we had no outstanding borrowings under the Line of Credit Agreement
and we were in compliance with all covenants. For more information regarding the Line of Credit Agreement, see
Part II, Item 8, “Note 7--Debt” to our Consolidated Financial Statements in this Annual Report on Form 10-K.
56
Contractual Obligations and Commitments
The following table presents a summary of our contractual obligations and commitments as of December 31, 2019.
Payments Due Within
More than
1 Year
2-3 Years 4-5 Years 5 Years
Total
(In thousands)
Operating leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 6,398 $ 13,214 $ 13,795 $ 19,590 $ 52,997
3,158
Finance leases (principal and interest) . . . . . . . . . . . . . . . . . . .
Unsecured convertible senior notes . . . . . . . . . . . . . . . . . . . . .
262,500
22,693
Goods & services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 42,446 $ 41,429 $ 237,507 $ 19,966 $ 341,348
158
223,125
429
1,566
26,250
399
1,434
13,125
21,489
—
—
376
Operating Leases
We lease our office and laboratory space in The Omeros Building under a lease agreement with BMR - 201 Elliott
Avenue LLC. The initial term of the lease ends in November 2027 and we have two options to extend the lease term,
each by five years. We lease office and laboratory equipment under various operating and finance lease agreements with
initial terms of five years or less. As of December 31, 2019, the remaining aggregate non-cancelable rent payable under
the initial term of the lease, excluding common area maintenance and related operating expenses, is $53.0 million.
Convertible Notes
Refer to “Financial Condition - Liquidity and Capital Resources - Convertible Notes” above.
Goods & Services
We have certain non-cancelable obligations under other agreements for the acquisitions of goods and services
associated with the manufacturing of our product candidates, which contain firm commitments. As of December 31,
2019, our aggregate firm commitments are $22.7 million.
We may be required, in connection with in-licensing or asset acquisition agreements, to make certain royalty and
milestone payments and we cannot, at this time, determine when or if the related milestones will be achieved or whether
the events triggering the commencement of payment obligations will occur. Therefore, such payments are not included
in the table above. For information regarding agreements that include these royalty and milestone payment obligations,
see Part II, Item 8, “Note 10--Commitments and Contingencies” to our Consolidated Financial Statements in this Annual
Report on Form 10-K.
Critical Accounting Policies and Significant Judgments and Estimates
The preparation of our consolidated financial statements, in conformity with U.S. generally accepted accounting
principles (“GAAP”), requires management to make estimates and assumptions that affect the amounts reported in the
financial statements and accompanying notes. We base our estimates on historical experience and on various other
factors that we believe are reasonable under the circumstances; however, actual results could differ from those estimates.
An accounting policy is considered critical if it is important to a company’s financial condition and results of operations
and if it requires the exercise of significant judgment and the use of estimates on the part of management in its
application. Although we believe that our judgments and estimates are appropriate, actual results may differ materially
from our estimates. For a summary of our critical accounting policies, See Part II, Item 8, “Note 2--Significant
Accounting Policies” to our Consolidated Financial Statements in this Annual Report on Form 10-K.
57
We believe the following to be our critical accounting policies because they are both important to the portrayal of
our financial condition and results of operations and they require critical judgment by management and estimates about
matters that are uncertain:
•
•
•
•
revenue recognition;
research and development expenses, primarily related to the manufacturing of drug product;
accounting for lease agreements, primarily related to our computation of incremental borrowing rate; and
stock-based compensation, primarily related to our fair value assumptions.
If actual results or events differ materially from those contemplated by us in making these estimates, our reported
financial condition and results of operations for future periods could be materially affected.
Revenue Recognition
Product Sales, Net: We generally record revenue from product sales when the product is delivered to our
wholesalers which is generally when we satisfy all performance obligations. Product sales are recorded net of wholesaler
distribution fees and estimated chargebacks, rebates, returns and purchase-volume discounts. Accruals or allowances are
established for these deductions in the same period when revenue is recognized, and actual amounts incurred are offset
against the applicable accruals or allowances. We reflect each of these accruals or allowances as either a reduction in the
related accounts receivable or as an accrued liability depending on how the amount is expected to be settled.
Chargebacks and Rebates: Provisions for chargebacks are determined utilizing historical and projected payer mix
and information regarding sell-through and inventory on-hand received directly from wholesalers. Chargebacks are
generally settled within four weeks of recording product sales revenue.
We provide reimbursement support services and financial assistance in the form of a rebate to patients whose
commercial insurance is inadequate to cover the full cost of OMIDRIA. We apply an experience ratio based on historical
and projected patient claims. This experience ratio is applied to product sales to determine the patient rebate accrual and
is being reviewed and updated periodically to reflect actual results.
We provide rebate payments for which ASCs qualify by meeting or exceeding purchase volumes of OMIDRIA
under our purchase volume-discount program. We calculate rebate payment amounts due under this program based on
actual qualifying purchase volumes and apply a contractual discount rate. For purchases of OMIDRIA not yet reported
as sold-through to the ASC by our wholesalers, we apply an experience ratio to product sales to determine the rebate
accrual. This experience ratio is being reviewed and updated periodically to reflect actual results.
Distribution Fees and Product Return Allowances: We pay our wholesalers a distribution fee for services that they
perform for us based on the wholesaler average cost value of their purchases of OMIDRIA. We record a provision
against product sales for these charges at the time of sale to the wholesaler.
We allow for the return of product up to 12 months past its expiration date or for product that is damaged. In
estimating product returns, we take into consideration our return experience to date, the remaining shelf-life of product
we have previously sold, inventory in the wholesale channel and our expectation that product is typically not held by the
healthcare providers based on the frequency of their reorders.
Research and Development Expenses
Research and development costs are comprised primarily of:
•
contracted research and manufacturing costs;
58
•
•
•
•
•
clinical study costs;
costs of personnel, including salaries, benefits and stock compensation;
consulting arrangements;
depreciation and an allocation of our occupancy costs; and
other expenses incurred to sustain our overall research and development programs.
Contracted research and manufacturing costs are primarily incurred in the development and production of our drug
substance and drug product candidates. Prior to approval, our estimates are based on the timing of services provided. We
record accrued expenses equal to our estimated expense in excess of amount invoiced by the suppliers.
Clinical trial expenses requires certain estimates. We estimate these costs on a cost per patient that varies depending
on the clinical trial site. As actual costs become known to us, we adjust our estimates; these changes in estimates may
result in understated or overstated expenses at any given point in time.
Right-of-Use Assets and Related Lease Liabilities
On January 1, 2019, we adopted Accounting Standards Update (ASU) 2016-02, Leases, (Topic 842) using a
modified retrospective approach versus recasting the prior periods presented. For a summary of the adoption of this
critical accounting policies, See Part II, Item 8, “Note 2--Significant Accounting Policies” to our Consolidated Financial
Statements in this Annual Report on Form 10-K.
We record operating leases on our Consolidated Balance Sheet as right-of-use assets and recognize the related lease
liabilities equal to the fair value of the lease payments using our incremental borrowing rate when the implicit rate in the
lease agreement is not readily available. We derived our incremental borrowing rate by assessing rates in recent market
transactions, as adjusted for security interests and our credit quality. A change in the calculated incremental borrowing
rate of 100 basis points would not be material to our consolidated financial statements.
Stock-Based Compensation
Stock-based compensation expense is recognized for all share-based payments made to employees, directors and
non-employees based on estimated fair values. The fair value of our stock options is calculated using the Black-Scholes
option valuation model, which requires assumptions, including volatility, forfeiture rates and expected option life. We
estimate forfeitures for expense recognition based on our historical experience. Groups of employees that have similar
historical forfeiture behavior are considered separately. If any of the assumptions used in the Black-Scholes model
change significantly, stock-based compensation expense for new awards may differ materially from that recorded for
existing awards and stock-based compensation for non-employees will vary as the awards are re-measured over the
vesting term.
Recent Accounting Pronouncements
Please refer to Part II, Item 8, “Note 2--Significant Accounting Policies” to our Consolidated Financial Statements
in this Annual Report in Form 10-K for information regarding recent accounting pronouncements.
Off-Balance Sheet Arrangements
We have not engaged in any off-balance sheet arrangements.
59
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk is primarily confined to our investment securities and debt. The primary objective of
our investment activities is to preserve our capital to fund operations, and we do not enter into financial instruments for
trading or speculative purposes. We also seek to maximize income from our investments without assuming significant
risk. To achieve our objectives, we maintain a portfolio of investments in high-credit-quality securities. As of
December 31, 2019, we had cash, cash equivalents and short-term investments of $60.8 million. In accordance with our
investment policy, we invest funds in highly liquid, investment-grade securities. The securities in our investment
portfolio are not leveraged and are classified as available-for-sale. We currently do not hedge interest rate exposure.
Because of the short-term maturities of our investments, we do not believe that an increase in market rates would have a
material negative effect on the realized value of our investment portfolio. We actively monitor changes in interest rates
and, with our current portfolio of short-term investments, we are not exposed to potential loss due to changes in interest
rates.
60
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Balance Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Operations and Comprehensive Loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statement of Shareholders’ Deficit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Cash Flows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes to Consolidated Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
62
64
65
66
67
68
Page
61
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors
Omeros Corporation
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Omeros Corporation (the Company) as of
December 31, 2019 and 2018, the related consolidated statements of operations and comprehensive loss, shareholders' deficit
and cash flows for each of the three years in the period ended December 31, 2019, and the related notes (collectively referred
to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the consolidated
financial position of the Company at December 31, 2019 and 2018, and the consolidated results of its operations and its cash
flows for each of the three years in the period ended December 31, 2019, in conformity with U.S. generally accepted
accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United
States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2019, based on criteria
established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (2013 framework), and our report dated March 2, 2020 expressed an unqualified opinion thereon.
The Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a
going concern. As discussed in Note 1 to the financial statements, the Company has suffered losses from operations and has
stated that substantial doubt exists about the Company’s ability to continue as a going concern. Management's evaluation of the
events and conditions and management’s plans regarding these matters are also described in Note 1. The consolidated financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
Adoption of ASU No. 2016-02
As discussed in Note 2 to the consolidated financial statements, the Company has changed its method for accounting for
leases in 2019 due to the adoption of ASU No. 2016-02, Leases (Topic 842).
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
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. 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.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial
statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or
disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or
complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated
62
financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion
on the critical audit matter or on the accounts or disclosures to which it relates.
Patient Rebate Revenue Deduction
Description of
the Matter
As more fully described in Note 2 of the financial statements, product sales to wholesalers are recorded net
of revenue deductions. At December 31, 2019, reserves and allowances for revenue deductions totaled
$12.5 million of which patient rebates is the most judgmental component. The portion of the revenue
deductions related to patient rebates is determined by applying an experience ratio to product sales. The
experience ratio is based on historical and projected patient claims.
Auditing management’s determination of patient rebates was complex and requires judgment due to the
level of estimation involved in management’s assumptions used to determine the experience ratio. In
particular, management was required to estimate patient rebates for which claims have not been submitted
to the Company as of December 31, 2019.
How We
Addressed the
Matter in Our
Audit
We obtained an understanding, evaluated the design, and tested the operating effectiveness of the
Company’s internal controls over management’s process for estimating patient rebates, including
management’s determination of the experience ratio.
To test the patient rebates reserve, we performed audit procedures that included, among others, evaluating
the significant assumptions and the accuracy and completeness of underlying data used in management’s
calculations. We compared the significant assumptions used by management to historical ratios of rebate
claims to product sales and other relevant factors. We also assessed the historical accuracy of management’s
estimates by comparing previous estimates of patient rebates to the amount of actual payments in
subsequent periods.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 1998.
Seattle, Washington
March 2, 2020
63
OMEROS CORPORATION
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
December 31,
2019
2018
Assets
Current assets:
Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Short-term investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Receivables, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expense and other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property and equipment, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Right of use assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restricted investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Advanced payments, non-current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 136,969 $
3,084 $
57,704
35,185
1,147
6,625
103,745
3,829
27,082
1,154
1,159
5,861
54,637
22,818
88
6,463
89,867
3,845
—
1,154
1,070
95,936
Liabilities and shareholders’ deficit
Current liabilities:
Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Accrued expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current portion of lease liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lease liabilities, non-current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Unsecured convertible senior notes, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred rent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Commitments and contingencies (Note 10)
Shareholders’ deficit:
Preferred stock, par value $0.01 per share, 20,000,000 shares authorized; none
5,328 $
46,627
3,504
55,459
32,318
158,213
—
6,281
30,186
889
37,356
1,578
148,981
8,177
issued and outstanding at December 31, 2019 and December 31, 2018. . . . . . . . . . . .
—
—
Common stock, par value $0.01 per share, 150,000,000 shares authorized at
December 31, 2019 and December 31, 2018; 54,200,810 and 49,011,684 shares
issued and outstanding at December 31, 2019 and December 31, 2018, respectively.
Additional paid-in capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated deficit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total shareholders’ deficit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities and shareholders’ deficit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 136,969 $
542
625,048
(734,611)
(109,021)
490
549,479
(650,125)
(100,156)
95,936
See accompanying Notes to Consolidated Financial Statements
64
OMEROS CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
Year Ended December 31,
2018
2017
2019
Revenue:
Product sales, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
111,805 $
29,868 $
64,826
Costs and expenses:
Cost of product sales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selling, general and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total costs and expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss on early extinguishment of debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss before income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income tax benefit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Comprehensive loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Basic and diluted net loss per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Weighted-average shares used to compute basic and diluted net loss
865
109,696
64,626
175,187
(63,382)
—
(22,657)
1,553
(84,486)
—
512
89,860
51,718
142,090
(112,222)
(12,993)
(16,252)
1,781
(139,686)
12,929
(84,486) $ (126,757) $
(84,486) $ (126,757) $
(2.61) $
(1.71) $
1,078
55,599
52,044
108,721
(43,895)
—
(11,030)
1,444
(53,481)
—
(53,481)
(53,481)
(1.17)
per share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
49,523,444
48,582,636
45,539,362
See accompanying Notes to Consolidated Financial Statements
65
OMEROS CORPORATION
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ DEFICIT
(In thousands, except share data)
Balance at December 31, 2016 . . . . . . . . . . . . . . . . . . . . . 43,819,133 $ 438 $ 432,002 $ (469,887) $
Issuance of common stock in direct offering, net of
Common Stock
Shares
Additional
Paid-in
Amount Capital
Accumulated Shareholders’
Deficit
Total
Deficit
(37,447)
offering costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3,000,000
30
63,627
—
63,657
Issuance of common stock upon exercise of stock
options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1,392,093
—
—
Balance at December 31, 2017 . . . . . . . . . . . . . . . . . . . . . 48,211,226
14
—
—
11,755
12,688
—
482 520,072
—
—
(53,481)
(523,368)
11,769
12,688
(53,481)
(2,814)
Issuance of common stock upon exercise of stock
options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
800,458
8
6,724
—
6,732
Issuance of warrants in connection with debt
amendment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation . . . . . . . . . . . . . . . . . . . . . . .
Premium paid for Capped Call in connection with
Convertible Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equity component of issuance of Convertible Notes . .
Tax benefit related to equity component of
—
—
—
—
1,424
11,713
—
—
1,424
11,713
—
—
— (33,180)
55,655
—
—
—
(33,180)
55,655
Convertible Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
—
—
Balance at December 31, 2018 . . . . . . . . . . . . . . . . . . . . . 49,011,684
Issuance of common stock in direct offering, net of
— (12,929)
—
—
— (126,757)
(650,125)
490 549,479
(12,929)
(126,757)
(100,156)
offering costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4,389,311
44
54,194
—
54,238
Issuance of common stock upon exercise of stock
options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7,598
13,785
(84,486)
Balance at December 31, 2019 . . . . . . . . . . . . . . . . . . . . . 54,200,810 $ 542 $ 625,048 $ (734,611) $ (109,021)
799,815
—
—
—
—
(84,486)
7,590
13,785
—
8
—
—
See accompanying Notes to Consolidated Financial Statements
66
OMEROS CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Year Ended December 31,
2018
2019
2017
Operating activities:
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ (84,486) $ (126,757) $ (53,481)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-cash interest expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss on early extinguishment of debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred income tax . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fair value adjustment to convertible notes in equity . . . . . . . . . . . . . . . . .
Changes in operating assets and liabilities:
Receivables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and other assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts payable and accrued expenses . . . . . . . . . . . . . . . . . . . . . . . .
Net cash used in operating activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Investing activities:
Purchases of property and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchases of investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from the sale and maturities of investments . . . . . . . . . . . . . . . . . . .
Net cash (used in) provided by investing activities . . . . . . . . . . . . . . . . . . . . . . .
Financing activities:
13,785
9,232
1,790
—
—
—
11,713
5,635
962
12,993
(12,929)
354
12,688
4,187
551
—
—
—
(12,367)
(1,059)
(251)
13,283
(60,073)
(5,674)
355
(498)
10,109
(103,737)
(5,107)
685
(5,270)
9,520
(36,227)
(334)
(58,217)
55,150
(3,401)
(567)
(68,782)
94,500
25,151
(350)
(65,326)
28,078
(37,598)
Proceeds from issuance of convertible senior notes . . . . . . . . . . . . . . . . . . . .
Proceeds from debt borrowings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds upon exercise of stock options and warrants . . . . . . . . . . . . . . . . . .
Proceeds from issuance of common stock, net . . . . . . . . . . . . . . . . . . . . . . . . .
Release in restricted investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repayment of debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Premium paid for capped call option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Payments on debt prepayment and extinguishment . . . . . . . . . . . . . . . . . . . . .
Payments for debt issuance costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Principal payments on finance lease liabilities . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash provided by financing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net (decrease) increase in cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . .
Cash and cash equivalents at beginning of period . . . . . . . . . . . . . . . . . . . . . . . .
Cash and cash equivalents at end of period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
—
—
7,598
54,238
—
—
—
—
—
(1,139)
60,697
(2,777)
5,861
3,084 $
210,000
44,550
6,732
—
4,681
(132,077)
(33,180)
(11,902)
(6,800)
(951)
81,053
2,467
3,394
5,861 $
—
—
11,769
63,657
—
—
—
—
—
(431)
74,995
1,170
2,224
3,394
Supplemental cash flow information
Cash paid for interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 13,462 $
Property acquired under finance lease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
1,440 $
— $
Conversion of accrued interest to debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
— $
Fair value of warrants issued in connection with debt amendment . . . . . . . . $
8,896 $
2,118 $
3,408 $
1,424 $
6,895
1,141
3,315
—
See accompanying Notes to Consolidated Financial Statements
67
OMEROS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1—Organization and Basis of Presentation
Organization
We are a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing
small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation,
complement-mediated diseases, disorders of the central nervous system, and immune-related diseases, including cancers.
Our first drug product, OMIDRIA, is marketed in the United States (U.S.) for use during cataract surgery or intraocular
lens replacement.
Basis of Presentation
Our consolidated financial statements include the financial position and results of operations of Omeros Corporation
(Omeros) and our wholly owned subsidiaries. All inter-company transactions have been eliminated. The accompanying
consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles
(GAAP). Certain prior year amounts in the balance sheet, statement of cash flows and the footnotes have been
reclassified in the consolidated financial statements to conform to the current year presentation.
Going Concern Discussion
As of December 31, 2019, we had cash, cash equivalents and investments of $60.8 million, net working capital of
$48.3 million and an accounts receivable based line of credit that allows us to borrow up to $50.0 million depending on
our eligible accounts receivable borrowing base. We have incurred losses from operations of $63.4 million,
$112.2 million and $43.9 million in 2019, 2018 and 2017, respectively, used cash in operating activities of $60.1 million,
$103.7 million and $36.2 million in 2019, 2018 and 2017, respectively and anticipate that we will continue to incur
losses until such time as revenues exceed operating costs.
OMIDRIA pass-through reimbursement is scheduled to end on September 30, 2020. As such, we cannot predict
with precision future OMIDRIA revenues due to the uncertain impact on sales of OMIDRIA in second half of 2020 and
beyond. Similarly, we are unable to include in the determination regarding our prospects as a going concern amounts
available under our revolving line of credit or any proceeds from debt transactions or other financing instruments despite
our successful track record in accessing capital through these avenues. We also have not included any potential
partnerships related to our products or product candidates. The conditions described above, when evaluated within the
constraints of the accounting literature, raise substantial doubt with respect to our ability to meet our obligations through
March 2, 2021 and, therefore, to continue as a going concern.
We plan to continue to fund our operations through proceeds from sales of OMIDRIA and, in addition, we may
utilize funds available under our receivable-based line of credit, which allows us to borrow up to $50 million based on
our available accounts-receivable borrowing base. Should it be necessary or determined to be strategically advantageous,
we also could pursue debt financings, public and private offerings of our equity securities similar to those we have
completed previously, and/or other strategic transactions, which may include licensing a portion of our existing
technology. If these capital sources, for any reason, are needed but inaccessible, it would have a significantly negative
effect on our financial condition. Should it be necessary to manage our operating expenses, we would reduce our
projected cash requirements through reduction of our expenses by delaying clinical trials, reducing selected research and
development efforts, and/or implementing other restructuring activities.
The accompanying consolidated financial statements have been prepared on a going-concern basis, which
contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The
accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on
the recoverability and classification of assets or the amounts and classification of liabilities that may result from
uncertainty related to our ability to continue as a going concern.
68
Segments
We operate in one segment. Management uses cash flow as the primary measure to manage our business and does
not segment our business for internal reporting or decision-making.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant items
subject to such estimates include revenue recognition, accruals for manufacturing of drug product, clinical drug supply
and clinical trials, lease liabilities, and stock-based compensation expense. We base our estimates on historical
experience and on various other factors that we believe are reasonable under the circumstances; however, actual results
could differ from these estimates.
Note 2—Significant Accounting Policies
Cash and Cash Equivalents, Short-Term Investments and Restricted Investments
Cash and cash equivalents include highly liquid investments with a maturity of three months or less on the date of
purchase. Short-term investment securities are classified as available-for-sale and are carried at fair value. Unrealized
gains and losses, if any, are reported as a separate component of shareholders’ deficit. Amortization, accretion, interest
and dividends, realized gains and losses and declines in value judged to be other-than-temporary are included in other
income. The cost of securities sold is based on the specific-identification method. Investments in securities with
maturities of less than one year, or those for which management intends to use the investments to fund current
operations, are included in current assets. We evaluate whether an investment is other-than-temporarily impaired based
on the specific facts and circumstances. Factors that are considered in determining whether an other-than-temporary
decline in value has occurred include: the market value of the security in relation to its cost basis; the financial condition
of the investee; and the intent and ability to retain the investment for a sufficient period of time to allow for recovery in
the market value of the investment. Restricted investments are held in money-market funds.
As of December 31, 2019 and 2018, all investments are classified as short-term and available-for-sale. Investment
income, which is included as a component of other income, consists primarily of interest earned.
Inventory
Inventory is stated at the lower of cost or market determined on a specific identification basis in a manner that
approximates the first-in, first-out (FIFO) method. Costs include amounts related to third-party manufacturing,
transportation and internal labor and overhead. Capitalization of costs as inventory begins when the product candidate
receives regulatory approval in the U.S. or the European Union (EU). We expense inventory costs related to product
candidates as research and development expenses prior to receiving regulatory approval in the respective territory.
Inventory is reduced to net realizable value for excess and obsolete inventories based on forecasted demand.
Receivables, Net
Receivables relate primarily to sales of OMIDRIA to wholesalers and include reductions for estimated chargebacks
and product returns that are expected to be settled through reductions in receivables. Remaining receivables consist of
amounts from subleases for space in our facilities. Considering the nature and historic collectability of our receivables,
we concluded an allowance for doubtful accounts is not necessary as of December 31, 2019 and 2018.
Property and Equipment, Net
Property and equipment are stated at cost, and depreciation is calculated using the straight-line method over the
estimated useful life of the assets, which is generally three to 10 years. Equipment acquired through finance leases is
69
recorded as property and equipment and is amortized over the shorter of the useful lives of the related assets or the lease
term. Expenditures for repairs and maintenance are expensed as incurred.
Right-of-Use Assets and Related Lease Liabilities
On January 1, 2019, we adopted Accounting Standards Update (ASU) 2016-02, Leases, (Topic 842) using a
modified retrospective approach versus recasting the prior periods presented. We elected the package of practical
expedients permitted under the transition guidance, which allowed us to carryforward our historical assessment of
whether (i) contracts contain leases, (ii) lease classifications and (iii) initial direct costs. Upon adoption we recognized
right-of-use assets and lease liabilities of $17.7 million and $26.4 million, respectively. The balance of the net right-of-
use asset included the reversal of the outstanding balance of deferred rent of $8.7 million.
We record operating leases as right-of-use assets and recognize the related lease liabilities equal to the fair value of
the lease payments using our incremental borrowing rate when the implicit rate in the lease agreement is not readily
available. We recognize variable lease payments, when incurred. Costs associated with operating lease assets are
recognized on a straight-line basis within operating expenses over the term of the lease.
We record finance leases as a component of property and equipment and amortize these assets within operating
expenses on a straight-line basis to their residual values over the shorter of the term of the underlying lease or the
estimated useful life of the equipment. The interest component of a finance lease is included in interest expense and
recognized using the effective interest method over the lease term.
We account for leases with initial terms of 12 months or less as operating expenses on a straight-line basis over the
lease term.
Impairment of Long-Lived Assets
We assess the impairment of long-lived assets, primarily property and equipment whenever events or changes in
circumstances indicate that the carrying value of an asset may not be recoverable. Recoverability of these assets is
measured by comparing the carrying value to future undiscounted cash flows that the asset is expected to generate. If the
asset is considered to be impaired, the amount of any impairment will be reflected in the results of operations in the
period of impairment. We have not recognized any impairment losses for the years ending December 31, 2019, 2018 and
2017.
Revenue Recognition
When we enter into a customer contract, we perform the following five steps: (i) identify the contract 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) we satisfy a
performance obligation.
Product Sales, Net
We generally record revenue from product sales when the product is delivered to our wholesalers. Product sales are
recorded net of wholesaler distribution fees and estimated chargebacks, rebates, returns and purchase-volume discounts.
Accruals or allowances are established for these deductions in the same period when revenue is recognized, and actual
amounts incurred are offset against the applicable accruals or allowances. We reflect each of these accruals or
allowances as either a reduction in the related accounts receivable or as an accrued liability depending on how the
amount is expected to be settled.
Chargebacks and Rebates: Provisions for chargebacks are determined utilizing historical and projected payer mix
and information regarding sell-through and inventory on-hand received directly from wholesalers. Chargebacks are
generally settled within four weeks of recording product sales revenue.
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We provide reimbursement support services and financial assistance in the form of a rebate to patients whose
commercial insurance is inadequate to cover the full cost of OMIDRIA. We apply an experience ratio based on historical
and projected patient claims. This experience ratio is applied to product sales to determine the patient rebate accrual and
is being reviewed and updated periodically to reflect actual results.
We provide rebate payments for which ASCs qualify by meeting or exceeding purchase volumes of OMIDRIA
under our purchase volume-discount program. We calculate rebate payment amounts due under this program based on
actual qualifying purchase volumes and apply a contractual discount rate. For purchases of OMIDRIA not yet reported
as sold-through to the ASC by our wholesalers, we apply an experience ratio to product sales to determine the rebate
accrual. This experience ratio is being reviewed and updated periodically to reflect actual results.
Distribution Fees and Product Return Allowances: We pay our wholesalers a distribution fee for services that they
perform for us based on the wholesaler average cost value of their purchases of OMIDRIA. We record a provision
against product sales for these charges at the time of sale to the wholesaler.
We allow for the return of product up to 12 months past its expiration date or for product that is damaged. In
estimating product returns, we take into consideration our return experience to date, the remaining shelf-life of product
we have previously sold, inventory in the wholesale channel and our expectation that product is typically not held by the
healthcare providers based on the frequency of their reorders.
Research and Development
Research and development expenses are comprised primarily of contracted research and manufacturing costs prior
to approval; costs for personnel, including salaries, benefits and stock compensation; clinical study costs; contracted
research; manufacturing costs prior to approval; consulting services; depreciation; materials and supplies; milestones; an
allocation of our occupancy costs; and other expenses incurred to sustain our overall research and development
programs. Advance payments for goods or services that will be used or rendered for future research and development
activities are deferred and then recognized as an expense as the related goods are delivered or the services are performed,
or when the goods or services are no longer expected to be provided. All other research and development costs are
expensed as incurred.
Selling, General and Administrative
Selling, general and administrative expenses are comprised primarily of salaries, benefits, and stock-compensation
costs for sales, marketing, and other personnel not directly engaged in research and development. Additionally, selling,
general and administrative expenses include marketing and selling expenses, professional and legal services; patent
costs; depreciation, an allocation of our occupancy costs; and other general corporate expenses. Advertising costs, which
we consider to be media and marketing materials, are expensed as incurred and were $8.0 million, $2.5 million and
$0.3 million during the years ended December 31, 2019, 2018 and 2017, respectively.
Income Taxes
Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities and their tax bases. Deferred tax assets and
liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary
differences are expected to be recovered or settled. We recognize the effect of income tax positions only if those
positions are more likely than not of being sustained upon an examination. A valuation allowance is established when it
is more likely than not that the deferred tax assets will not be realized.
Stock-Based Compensation
Stock-based compensation expense is recognized for all share-based payments based on estimated fair values. The
fair value of our stock options is calculated using the Black-Scholes option-pricing model which requires judgmental
assumptions including volatility, forfeiture rates and expected option life. We use the straight-line method to allocate
71
compensation cost to reporting periods over each optionee’s requisite service period, which is generally the vesting
period.
Accumulated Other Comprehensive Loss
Accumulated other comprehensive loss is comprised of net loss and certain changes in equity that are excluded from
net loss. There was no difference between comprehensive loss and net loss for the years ended December 31, 2019, 2018
or 2017.
Financial Instruments and Concentrations of Credit Risk
Cash and cash equivalents, receivables, accounts payable and accrued liabilities, which are recorded at invoiced
amount or cost, approximate fair value based on the short-term nature of these financial instruments. The fair value of
short-term investments is based on quoted market prices. Financial instruments that potentially subject us to
concentrations of credit risk consist primarily of cash and cash equivalents, short-term investments and receivables. Cash
and cash equivalents are held by financial institutions and are federally insured up to certain limits. At times, our cash
and cash equivalents balance held at a financial institution may exceeds the federally insured limits. To limit the credit
risk, we invest our excess cash in high-quality securities such as money market mutual funds, certificates of deposit and
commercial paper.
Major Customers
We sell OMIDRIA through a limited number of wholesalers. Each of these wholesalers, together with entities under
their common control, accounted for greater than 10% of our total revenues for the years ended December 31, 2019,
2018 and 2017 and greater than 10% of accounts receivable as of December 31, 2019, 2018 and 2017 as noted below.
2019
2018
2017
Percentage
of Total
Revenue
Percentage
of Accounts
Receivable
Percentage
of Total
Revenue
Percentage
of Accounts
Receivable
Percentage
of Total
Revenue
Percentage
of Accounts
Receivable
Distributor A . . . . . . . . . . .
Distributor B . . . . . . . . . . .
Distributor C . . . . . . . . . . .
Distributor D . . . . . . . . . . .
25 %
24 %
29 %
22 %
23 %
19 %
33 %
25 %
31 %
27 %
22 %
20 %
27 %
25 %
25 %
23 %
29 %
26 %
22 %
23 %
31 %
23 %
26 %
20 %
Major Suppliers
We use a single contract manufacturer to supply the OMIDRIA drug product and a separate company to package
OMIDRIA for commercial sale. We generally use different contract manufacturers to produce drug substance, drug
product and to perform final packaging for our drug product candidates.
We endeavor to maintain reasonable levels of drug supply for our commercial and clinical trial use and other
manufacturers are available should we need to change suppliers. A change in suppliers, however, could cause a delay in
delivery of OMIDRIA or our clinical trial material that would adversely affect our business.
Recent Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses, (Topic 326) which changes
how entities account for credit losses on most financial assets and certain other instruments and expands disclosures. The
standard is effective for annual and interim periods beginning after December 15, 2019 with early adoption permitted.
We adopted the standard on January 1, 2020 and the adoption did not have a material impact on our consolidated
financial statements and disclosures.
72
In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software,
(Subtopic 350-40) related to the accounting for cloud computing arrangements to follow the internal-use software
guidance in determining which development costs to defer and recognize as an asset. We adopted the standard January 1,
2020 on a prospective basis and expect to capitalize certain cloud computing development costs and amortize them on a
straight-line basis over the expected useful-life of the related systems.
Note 3—Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares
outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average
number of common shares and dilutive common share equivalents outstanding for the period, determined using the
treasury-stock method. Common share equivalents are excluded from the diluted net loss per share computations if their
effect is anti-dilutive.
The basic and diluted net loss per share amounts for the years ended December 31, 2019, 2018 and 2017 were
computed based on the shares of common stock outstanding during the respective periods. Potentially dilutive securities
excluded from the diluted net loss per share calculation are as follows:
Outstanding options to purchase common stock . . . . . . . . . . . . . . . . . . . . . . . . .
Outstanding warrants to purchase common stock . . . . . . . . . . . . . . . . . . . . . . . .
Total potentially dilutive shares excluded from loss per share . . . . . . . . . . .
Note 4—Accounts Receivable, Net
Accounts receivable, net consists of the following:
2019
Year Ended December 31,
2018
11,207,931 10,313,138 9,657,259
100,602
11,451,046 10,556,253 9,757,861
243,115
243,115
2017
Trade receivables, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Sublease and other receivables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total accounts receivables, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
December 31,
2019
2018
(In thousands)
35,074 $
111
35,185 $
22,654
164
22,818
Trade receivables are shown net of $1.6 million and $0.4 million of chargeback and product return allowances as of
December 31, 2019 and 2018, respectively.
Note 5—Fair-Value Measurements
As of December 31, 2019 and 2018, all investments were classified as short-term and available-for-sale. Investment
income, which was included as a component of other income, consists of interest earned.
On a recurring basis, we measure certain financial assets at fair value. Fair value is defined as the exchange price
that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the measurement date. The
accounting standard establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs,
where available. The following summarizes the three levels of inputs required:
Level 1—Observable inputs for identical assets or liabilities, such as quoted prices in active markets;
Level 2—Inputs other than quoted prices in active markets that are either directly or indirectly observable; and
73
Level 3—Unobservable inputs in which little or no market data exists, therefore they are developed using
estimates and assumptions developed by us, which reflect those that a market participant would use.
Our fair-value hierarchy for our financial assets measured at fair value on a recurring basis are as follows:
Level 1
Level 2
Level 3
Total
December 31, 2019
(In thousands)
Assets:
Money-market funds classified as non-current restricted investments . . $
1,154 $
Money-market funds classified as short-term investments . . . . . . . . . . . 57,704
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 58,858 $
— $
—
— $
1,154
— $
— 57,704
— $ 58,858
Level 1
Level 2
Level 3
Total
December 31, 2018
(In thousands)
Assets:
Money-market funds classified as non-current restricted investments . . $ 1,154 $
Money-market funds classified as short-term investments . . . . . . . . . . .
54,637
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 55,791 $
— $
—
— $
— $ 1,154
— 54,637
— $ 55,791
Cash held in demand deposit accounts of $3.1 million and $5.9 million is excluded from our fair-value hierarchy
disclosure as of December 31, 2019 and 2018, respectively. There were no unrealized gains or losses associated with our
short-term investments as of December 31, 2019 or 2018. The carrying amounts for receivables, accounts payable and
accrued liabilities, and other current monetary assets and liabilities, including debt and lease financing obligations,
approximate fair value.
See “Note 8--Convertible Senior Notes” for the carrying amount and estimated fair value of our 6.25% Convertible
Senior Notes due 2023.
Note 6—Certain Balance Sheet Accounts
Inventory
Inventory consists of the following:
Raw materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Work-in-progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Finished goods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
(In thousands)
91 $
338
718
1,147 $
83
—
5
88
December 31,
2019
December 31,
2018
74
Property and Equipment, Net
Property and equipment, net consists of the following:
Finance leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Laboratory equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Computer equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Office equipment and furniture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less accumulated depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total property and equipment, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
December 31,
2019
2018
(In thousands)
5,474 $
2,844
921
625
9,864
(6,035)
3,829 $
4,034
2,569
862
625
8,090
(4,245)
3,845
For the years ended December 31, 2019, 2018 and 2017, depreciation and amortization expenses were $1.8 million,
$1.0 million and $0.6 million, respectively.
Accrued Expenses
Accrued expenses consist of the following:
Contract research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Sales rebates, fees and discounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consulting and professional fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Employee compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clinical trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other accrued expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total accrued expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
December 31,
2019
2018
(In thousands)
24,107 $
10,870
3,610
3,546
1,982
1,640
872
46,627 $
12,012
8,075
3,669
2,714
820
1,677
1,219
30,186
Note 7—Debt
Note Payable
In October 2016, we entered into a note payable agreement (the Note) and borrowed $80.0 million. In May 2018,
we borrowed the remaining $45.0 million available under the Note and issued warrants to purchase up to 200,000 shares
of our common stock with an exercise price of $23.00 per share and total fair value of $1.4 million.
Interest accrued on the Note at an annual rate of 12.25% (4.00% of which we deferred by adding such amounts to
the aggregate principal amount outstanding). The Note required us to pay a back-end lender facility fee equal to 5.00%
of the aggregate principal amount borrowed and, upon early repayment, we were subject to a 4.0% prepayment fee.
In November 2018, we issued $210.0 million in principal amount of unsecured convertible senior notes (see
“Note 8--Convertible Senior Notes”) and repaid the Note. Upon repayment, we incurred a loss on early extinguishment
of debt of $13.0 million associated with the unamortized lender facility fee, debt issuance costs, debt discount and
prepayment fees upon repayment of the Note.
75
Line of Credit
In August 2019, we entered into a Loan and Security Agreement with Silicon Valley Bank, which provides for a
$50.0 million revolving line of credit facility (the Line of Credit Agreement). Under the Line of Credit Agreement we
may draw, on a revolving basis, up to the lesser of $50.0 million and 85.0% of our eligible accounts receivable, less
certain reserves. The Line of Credit Agreement is secured by all our assets excluding intellectual property and
development program inventories and matures in August 2022.
Interest on amounts outstanding is payable monthly at a floating rate equal to the greater of 5.50% and the prime
rate per annum. If the Line of Credit Agreement is terminated prior to the maturity date for any reason other than
replacement with a new Silicon Valley Bank (SVB) credit facility or a new syndicated facility in which SVB acts as the
agent, we are required to pay a termination fee of $1.0 million. We paid an initial commitment fee of $150,000 upon
closing and are required to pay additional commitment fees of $150,000 on each of the first and second anniversaries of
the closing date, or upon the earlier termination of, or default under, the Line of Credit Agreement.
The Line of Credit Agreement requires a lockbox arrangement whereby our trade accounts receivable collections are
deposited into a control account. Amounts deposited in the account are transferred daily to our operating account, except
that during periods of reduced liquidity or upon an event of default, the amounts received in the control account are
applied to reduce the outstanding obligations under the Line of Credit Agreement. The Line of Credit Agreement
includes customary events of default that include, among other things, breach, non-payment, inaccuracy of
representations and warranties, the occurrence of a material adverse change in our business or prospects for repayment
of the Line of Credit, cross default to material indebtedness or material agreements, bankruptcy and insolvency, material
judgments and a change in control. In the event of default, SVB may require all obligations under the Line of Credit
Agreement to be immediately due and payable and charge a default rate of interest thereon. Additionally, under the loan
and security agreement with SVB, we have agreed not to pay any dividends.
As of December 31, 2019, we had no outstanding borrowings under the Line of Credit Agreement.
Note 8—Convertible Senior Notes
In November 2018, we issued $210.0 million aggregate principal amount 6.25% Convertible Senior Notes due 2023
(the Convertible Notes) and received net proceeds of $24.0 million, as summarized below:
(In thousands)
Convertible Notes initially issued . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 210,000
(146,046)
Repayment of previously outstanding loan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(33,180)
Purchase of Capped Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(6,800)
Issuance costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23,974
Net proceeds available for corporate use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
The Convertible Notes accrue interest at an annual rate of 6.25% per annum, payable semi-annually in arrears on
May 15 and November 15 of each year, beginning on May 15, 2019. The Convertible Notes mature on November 15,
2023, unless earlier repurchased, redeemed or converted in accordance with their terms and are unsecured.
The Convertible Notes will be convertible into cash, shares of our common stock or a combination thereof, as we
elect at our sole discretion. The initial conversion rate is 52.0183 shares of our common stock per $1,000 of note
principal (equivalent to an initial conversion price of approximately $19.22 per share of common stock), subject to
adjustment in certain circumstances.
The Convertible Notes will be convertible at the option of the holders on or after May 15, 2023 at any time prior to
the close of business on the second scheduled trading day immediately preceding the stated maturity date of
76
November 15, 2023. Additionally, holders may convert their Convertible Notes at their option at specified times prior to
the maturity date of November 15, 2023, only if:
(1) during any calendar quarter beginning after March 31, 2019, the last reported sale price per share of our
common stock exceeds 130% of the conversion price of the Convertible Notes for each of at least 20
trading days in the period of 30 consecutive trading days ending on, and including, the last trading day of the
immediately preceding calendar quarter;
(2) during the five consecutive business days immediately after any five-consecutive-trading-day period (such five-
consecutive-trading-day period, the “measurement period”) in which the trading price per $1,000 principal
amount of Convertible Notes for each trading day of the measurement period was less than 98% of the product
of the last reported sale price per share of our common stock on such trading day and the conversion rate on
such trading day;
(3) upon the occurrence of certain corporate events or distributions of our common stock; or
(4) we call the Convertible Notes for redemption.
Subject to the satisfaction of certain conditions, we may redeem all, but not less than all, of the Convertible Notes at
our option prior to the maturity date at a cash redemption price equal to the principal amount of the Convertible Notes to
be redeemed, plus any accrued and unpaid interest. The Convertible Notes are subject to redemption only if certain
requirements are satisfied, including that the last reported sale price per share of our common stock exceeds 150% of the
conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive
trading days ending on, and including, the trading day immediately before the date we send the related redemption notice
and (ii) the trading day immediately before the date we send such notice.
In order to reduce the dilutive impact or potential cash expenditure associated with conversion of the Convertible
Notes, we used $33.2 million of the proceeds from sale of the Convertible Notes to enter into a capped call transaction
(the Capped Call Transaction). The Capped Call Transaction will cover, subject to anti-dilution adjustments substantially
similar to those applicable to the Convertible Notes, the number of shares of our common stock underlying the
Convertible Notes when our common stock is trading between the initial conversion price of approximately $19.22 and
$28.8360. However, if the market price of our common stock exceeds the $28.8360 cap price, then the conversion of the
Convertible Notes would have a dilutive impact and/or require a cash expenditure to the extent the market price exceeds
the cap price.
We evaluated the accounting for the issuance of the Convertible Notes and concluded that the embedded conversion
features meet the requirements for a derivative scope exception for instruments that are both indexed to an entity’s own
stock and classified in stockholders’ equity in its balance sheet, and that the cash conversion guidance applies.
Therefore, the Convertible Notes issuance proceeds of $210.0 million are allocated first to the liability component based
on the fair value of non-convertible debt with otherwise identical residual terms with the residual proceeds allocated to
equity for the conversion features. The debt issuance costs associated with the Convertible Notes of $6.8 million were
allocated to the liability and equity component in the same proportion as the issuance proceeds. We also evaluated the
interest feature on default and redemption features embedded in the Convertible Notes and concluded that they are
clearly and closely related to the Convertible Notes, and therefore they would not be separately accounted for as a
derivative. For the contingent interest features unrelated to our creditworthiness, we concluded that they should be
separately accounted for as a compound derivative instrument with de-minimis value. Further, we concluded the Capped
Call Transaction qualifies for a derivative scope exception for instruments that are both indexed to an entity’s own stock
and classified in stockholders’ equity in its balance sheet. Consequently, the fair value of the Capped Call of
$33.2 million is classified as equity and will not be subsequently remeasured.
77
The balance of our Convertible Notes at December 31, 2019 and 2018, is as follows:
December 31, December 31,
2019
2018
(In thousands)
Principal amount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 210,000 $ 210,000
Unamortized discount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(56,156)
Unamortized issuance costs attributable to principal amount . . . . . . . .
(4,863)
Total Convertible Notes, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 158,213 $ 148,981
Fair value of outstanding Convertible Notes . . . . . . . . . . . . . . . . . . . . . $ 208,163 $ 186,900
Amount by which the Convertible Notes if-converted value exceeds
(47,660)
(4,127)
their principal amount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
$
— $
—
The unamortized debt discount and debt issuance costs related to the Convertible Notes are being amortized to
interest expense using the effective interest method through the scheduled maturity of November 15, 2023.
The estimated fair value of the Convertible Notes at December 31, 2019, as determined through consideration of
quoted market prices, was $208.2 million. The fair value is classified as Level 3 due to the limited trading activity for the
Convertible Notes.
Note 9—Lease Liabilities
We have operating leases related to our office and laboratory space. The initial term of the leases is through
November 2027 and we have two options to extend the lease term, each by five years. We have finance leases for certain
laboratory and office equipment that have lease terms expiring through December 2023.
As described further in “Note 2--Significant Accounting Policies”, on January 1, 2019, we adopted ASU 2016-02,
Leases, (Topic 842) using a modified retrospective approach versus recasting the prior periods presented. The lease-
related assets and liabilities recorded on the balance sheet are as follows. Prior year financial statements were not recast
under the new standard and, therefore, those amounts are not presented below.
Assets
Operating lease assets . . . . . . . . . . . . . . . . . . . . . . . . . . .
Finance lease assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total lease assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Right of use assets
Property and equipment, net
(In thousands)
$
$
27,082
2,973
30,055
Classification on the Balance Sheet
December 31, 2019
Liabilities
Current:
Operating leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Finance leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current portion of lease liabilities
Current portion of lease liabilities
$
Non-current:
Operating leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Finance leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total lease liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lease liabilities, non-current
Lease liabilities, non-current
$
Weighted-average remaining lease term
Operating leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Finance leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Weighted-average discount rate
Operating leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Finance leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
78
2,282
1,222
30,772
1,546
35,822
7.8 years
2.5 years
12.85 %
12.17 %
The components of total lease costs are as follows:
Year Ended
December 31, 2019
(In thousands)
Lease cost
Operating lease cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Finance lease cost:
Amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Short-term lease cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Variable lease cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sublease income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total lease cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
4,604
1,340
337
275
2,045
(913)
7,688
The supplemental cash flow information related to leases during 2019 is as follows:
Cash paid for amounts included in the measurement of lease liabilities
$
Operating cash flows used for operating leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating cash flows used for finance leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Financing cash flows used for finance leases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
6,951
337
1,139
The future maturities of our lease liabilities as of December 31, 2019 are as follows:
Operating
Leases
Finance
Leases
(In thousands)
2020 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
2021 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2022 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2023 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2024 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Thereafter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total undiscounted lease payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lease liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
6,398 $
6,536
6,678
6,823
6,972
19,590
52,997
19,943
33,054 $
1,434
1,076
490
131
27
—
3,158
390
2,768
In 2019, we leased additional office and laboratory space in our headquarters building, which qualified as an
operating lease, and recorded additional right-of-use assets and lease liabilities of $10.4 million.
Note 10—Commitments and Contingencies
Contracts
We have various agreements with third parties that collectively require payment of termination fees totaling
$22.7 million as of December 31, 2019 if we cancel the work within specific time frames, either prior to commencing or
during performance of the contracted services.
Development Milestones and Product Royalties
We have licensed a variety of intellectual property from third parties that we are currently developing or may
develop in the future. These licenses may require milestone payments during the clinical development processes as well
as low single to low double-digit royalties on the net income or net sales of the product. For the years ended
79
December 31, 2019, 2018 and 2017, development milestones incurred were immaterial and we did not owe any
royalties.
Note 11—Shareholders’ Equity
Common Stock
As of December 31, 2019, we had reserved shares of common stock for the following purposes:
Options granted and outstanding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Options available for future grant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Common stock warrants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total shares reserved . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11,207,931
5,397,602
243,115
16,848,648
Securities Offerings – In December 2019, we sold 4.4 million shares of our common stock at a public offering price
of $13.10 per share. After deducting underwriter discounts and offering expense, we received net proceeds from the
transaction of $54.2 million.
In August 2017, we sold 3.0 million shares of our common stock at a public offering price of $22.75 per share. After
deducting underwriter discounts and offering expenses, we received net proceeds from the transaction of $63.6 million.
Warrants
In connection with various previously outstanding debt agreements we have issued warrants to purchase shares of
our common stock as follows:
Outstanding At
December 31, 2019
43,115
200,000
Note 12—Stock-Based Compensation
Expiration Date
May 18, 2023
April 12, 2023
$
$
Exercise Price
9.94
23.00
Our stock option plans provide for the grant of incentive and non-statutory stock options, stock appreciation rights,
restricted stock, restricted stock units, performance units, performance shares and other stock and cash awards to
employees, directors and consultants and subsidiary corporations’ employees and consultants. Stock options must be
granted with exercise prices not less than the fair market value of the common stock subject to the stock option on the
date of the grant and the options may not exceed 10 years. Any unvested stock options granted which are subsequently
canceled become available for future grant.
As of December 31, 2019, a total of 16.9 million shares were reserved for issuance under our stock plans and
outstanding warrants, of which 5.4 million were available for future grants which includes shares registered in June 2019
under the Omeros Corporation 2017 Omnibus Incentive Compensation Plan, as amended and restated effective June 7,
2019. In March 2020, annual stock option grants totaling approximately 1.6 million shares with an exercise price of
$11.91 per share were granted to all eligible employees. The options vest monthly on a straight-line basis over four
years.
80
Stock-based compensation expense is as follows:
Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 6,095 $ 4,961 $ 5,240
Selling, general and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7,448
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 13,785 $ 11,713 $ 12,688
7,690
6,752
The fair value of each option grant is estimated on the date of grant using the Black-Scholes option-pricing model.
The following assumptions were applied to stock option grants during the periods ended:
2019
Year Ended December 31,
2018
(In thousands)
2017
Estimated weighted-average fair value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 9.93
Weighted-average assumptions:
2019
Year Ended December 31,
2018
$ 10.32
2017
$ 8.66
Expected volatility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected term, in years . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Risk-free interest rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected dividend yield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
80 %
6.0
2.41 %
— %
74 %
6.0
78 %
6.0
2.68 % 2.05 %
— %
— %
During the years ended December 31, 2019 and 2018, we granted to non-employees options to purchase 20,000
shares and 20,000 shares of common stock, respectively. In connection with the non-employee options, we recognized
expense of $0.2 million, $0.2 million, and $0.5 million during the years ended December 31, 2019, 2018 and 2017,
respectively.
Stock option activity for all stock plans is as follows:
Weighted-
Average
Exercise
Price per Contractual Life
Remaining
Share
(In years)
Options
Outstanding
Aggregate
Intrinsic
Value
(In thousands)
Granted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exercised . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Forfeited . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance at December 31, 2018 . . . . . . . . . . . . . . . . . . . . . . . . . . . 10,313,138 $ 11.22
14.23
9.50
16.28
Balance at December 31, 2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . 11,207,931 $ 11.72
Vested and expected to vest at December 31, 2019 . . . . . . . . . . 10,876,043 $ 11.65
8,212,177 $ 10.87
Exercisable at December 31, 2019 . . . . . . . . . . . . . . . . . . . . . . . .
2,098,705
(799,815)
(404,097)
6.0 $
6.0 $
5.1 $
31,912
31,661
29,546
The total intrinsic value of options exercised during the years ended December 31, 2019, 2018 and 2017 was
$5.4 million, $11.4 million and $16.4 million, respectively.
At December 31, 2019, there were 3.0 million unvested options outstanding that will vest over a weighted-average
period of 2.6 years. The remaining estimated compensation expense to be recognized in connection with these unvested
options is $24.2 million.
81
Note 13—Income Taxes
The components of income tax benefit are as follows:
2019
December 31,
2018
(In thousands)
2017
Current income tax benefit:
Federal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current income tax benefit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
— $
—
—
— $
—
—
Deferred income tax benefit:
Federal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total deferred income tax benefit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income tax benefit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
—
—
—
— $
11,261
1,668
12,929
12,929 $
—
—
—
—
—
—
—
We have a history of losses and therefore have historically not made a provision for income taxes. However, in 2018
we recorded an income tax benefit of $12.9 million related to the issuance of our Convertible Notes. In accordance with
intra-period tax allocation rules, the deferred tax liability related to the equity component of convertible debt is a source
of income that can be used to recognize the tax benefit of the current year loss through continuing operations. The tax
benefit related to the issuance of our Convertible Notes occurred in 2018 and does not recur in subsequent years.
Deferred income taxes reflect the tax effect of net operating loss and tax credit carryforwards and the net temporary
differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used
for income tax purposes.
Significant components of deferred income taxes are as follows:
December 31,
2019
2018
(In thousands)
Deferred tax assets:
Net operating loss carryforwards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
Research and development tax credits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred rent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lease liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total deferred tax assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
126,794 $
40,654
9,959
—
7,908
14,555
199,870
113,928
35,739
8,969
2,037
—
10,413
171,086
Deferred tax liabilities:
Equity component of Convertible Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Right of use assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total deferred tax liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net deferred tax assets before valuation allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less valuation allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net deferred tax assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $
(11,082)
(6,480)
(17,562)
182,308
(182,308)
— $
(12,706)
—
(12,706)
158,380
(158,380)
—
As of December 31, 2019 and 2018, we had federal net operating loss carryforwards of approximately
$564.3 million and $513.2 million, respectively, and state net operating losses of approximately $170.5 million and
$125.0 million, respectively.
In certain circumstances, due to ownership changes, our net operating loss and tax credit carryforwards may be
subject to limitations under Section 382 of the Internal Revenue Code. To date, we have not completed a Section 382
82
study. Unless previously utilized, our net operating loss and research and development tax credit carryforwards expire
between 2020 and 2039.
We have established a 100% valuation allowance due to the uncertainty of our ability to generate sufficient taxable
income to realize the deferred tax assets. Our valuation allowance increased $23.9 million and $26.4 million in 2019 and
2018, respectively, primarily due to net operating losses incurred during these periods.
Reconciliation of income tax computed at federal statutory rates to the reported provisions for income taxes is as
follows:
Year ended December 31,
2018
2017
2019
U.S. Federal statutory rate on net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
State tax, net of federal tax benefit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Effects of statutory rate change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Change in valuation allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Tax credits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Effective tax rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(21)%
(2)%
— %
28 %
(6)%
1 %
— %
(21)%
(2)%
— %
19 %
(5)%
— %
(9)%
(34)%
(2)%
115 %
(60)%
(11)%
(8)%
— %
We file federal and certain state income tax returns, which provides varying statutes of limitations on assessments.
However, because of net operating loss carryforwards, substantially all of our tax years remain open to federal and state
tax examination.
We recognize interest and penalties related to the underpayment of income taxes as a component of income tax
expense. To date, there have been no interest or penalties charged to us in relation to the underpayment of income taxes.
Note 14—401(k) Retirement Plan
Our 401(k) retirement plan provides for an annual company discretionary match on employee contributions up to
4.0% of each participating employee’s eligible earnings, with a maximum company match of $4,000 per employee
per year. All employees are eligible to participate.
Note 15—Quarterly Information (Unaudited)
The following table summarizes the unaudited statements of operations and comprehensive loss for each quarter of
2019 and 2018 (in thousands, except per share amounts):
2019
For the Quarter Ended
Revenue (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 21,779 $ 26,753 $
Total costs and expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Basic and diluted net loss per share . . . . . . . . . . . . . . . . . . . . . . . . $
March 31, June 30, September 30, December 31,
33,417
57,121
(23,704)
(29,225)
(0.58)
29,856 $
40,957
(11,101)
(16,463)
41,018
(19,239)
(24,345)
36,091
(9,338)
(14,453)
(0.33) $
(0.50) $
(0.29) $
2018
For the Quarter Ended
Revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 1,588 $ 1,655 $
Total costs and expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Basic and diluted net loss per share . . . . . . . . . . . . . . . . . . . . . . . . $
March 31, June 30, September 30, December 31,
22,017
40,491
(18,474)
(23,534)
(0.48)
4,608 $
40,050
(35,442)
(39,472)
29,277
(27,689)
(30,054)
32,272
(30,617)
(33,696)
(0.81) $
(0.62) $
(0.70) $
83
(1) As further described in Note 1, OMIDRIA was reimbursed under Medicare Part B from January 1, 2015 through
December 31, 2017. For the period January 1, 2018 through September 30, 2018, OMIDRIA was not reimbursed
separately for procedures covered under Medicare Part B. Beginning October 1, 2018, OMIDRIA was again
reimbursed separately under Medicare Part B.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, evaluated
the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the
Exchange Act, as of December 31, 2019. Management recognizes that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily
applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the
evaluation of our disclosure controls and procedures as of December 31, 2019, our principal executive and principal
financial officers concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable
assurance level.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting,
as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Internal control over financial reporting is a
process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles.
Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting
objectives because of its inherent limitations. Internal control over financial reporting is a process that involves human
diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal
control over financial reporting also can be circumvented by collusion or improper management override. Because of
such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal
control over financial reporting. However, these inherent limitations are known features of the financial reporting
process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
Our management, with the participation of our principal executive and principal financial officers, conducted an
assessment of the effectiveness of our internal control over financial reporting as of December 31, 2019. In making this
assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway
Commission in Internal Control-Integrated Framework (2013 framework). Based on the results of this assessment and on
those criteria, our management concluded that our internal control over financial reporting was effective as of
December 31, 2019.
Ernst & Young LLP has independently assessed the effectiveness of our internal control over financial reporting as
of December 31, 2019 and its report is included below.
There was no change in our internal control over financial reporting identified in connection with the evaluation
required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during our fourth fiscal quarter of 2019
that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
84
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors
Omeros Corporation
Opinion on Internal Control over Financial Reporting
We have audited Omeros Corporation’s internal control over financial reporting as of December 31, 2019, based on
criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission (2013 framework), (the COSO criteria). In our opinion, Omeros Corporation (the Company)
maintained, in all material respects, effective internal control over financial reporting as of December 31, 2019, based on
the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board
(United States), the consolidated balance sheets of Omeros Corporation (the Company) as of December 31, 2019 and
2018, the related consolidated statements of operations and comprehensive loss, shareholders’ deficit and cash flows for
each of the three years in the period ended December 31, 2019, and the related notes of the Company and our report
dated March 2, 2020 expressed an unqualified opinion thereon that included an explanatory paragraph regarding the
Company’s ability to continue as a going concern.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and
for its assessment of the effectiveness of internal control over financial reporting included in the accompanying
Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion
on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm
registered with the 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 audit in accordance with the standards of the PCAOB. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an understanding of internal control over financial
reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness
of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the
circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles. A company’s internal control over financial reporting
includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately
and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance with generally
accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance
with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a
material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may
deteriorate.
Seattle, Washington
March 2, 2020
/s/ Ernst & Young LLP
85
ITEM 9B. OTHER INFORMATION
None.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item will be contained in our definitive proxy statement issued in connection with
the 2020 Annual Meeting of Shareholders and is incorporated herein by reference. Certain information required by this
item concerning executive officers is set forth in Part I of this Annual Report on Form 10-K under the heading
“Business- Information About Our Executive Officers and Significant Employees.”
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item will be contained in our definitive proxy statement issued in connection with
the 2020 Annual Meeting of Shareholders and is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED SHAREHOLDER MATTERS
Except for the information set forth below, the information required by this item will be contained in our definitive
proxy statement issued in connection with the 2020 Annual Meeting of Shareholders and is incorporated herein by
reference.
Securities Authorized for Issuance Under Equity Compensation Plans
The following table provides certain information regarding our equity compensation plans in effect as of
December 31, 2019:
Number of Securities
to be
Issued Upon Exercise
of
Weighted-
Average
Exercise Price
of
Outstanding
Options,
Outstanding Options, Warrants and
Warrants and Rights
Rights
Number of Securities
Remaining Available
for
Future Issuance
Under
Equity
Compensation
Plans
Equity compensation plans approved by security holders:
2017 Omnibus Incentive Compensation Plan (1) . . . . . . . .
2008 Equity Incentive Plan (2) . . . . . . . . . . . . . . . . . . . . . . .
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3,625,870 $
7,582,061 $
11,207,931 $
14.72
10.29
11.72
5,397,602
—
5,397,602
(1) Our 2017 Omnibus Incentive Compensation Plan (the “2017 Plan”) provides for the grant of incentive and
nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units and
performance shares to employees, directors and consultants and subsidiary corporations’ employees and consultants.
The 2017 Plan replaced the Omeros Corporation 2008 Equity Incentive Plan (the “2008 Plan”), and as a result we
will not grant any new awards under the 2008 Plan. Any stock option awards granted under the 2008 Plan that were
outstanding as of the effective date of the 2017 Plan remain in effect pursuant to their terms and, if the award is
canceled or is repurchased, the shares underlying such award become available for grant under the 2017 Plan.
(2) The 2008 Plan provided for the grant of incentive and nonstatutory stock options, restricted stock, stock appreciation
rights, performance units and performance shares to employees, directors and consultants and subsidiary
corporations’ employees and consultants.
86
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
The information required by this item will be contained in our definitive proxy statement issued in connection with
the 2020 Annual Meeting of Shareholders and is incorporated herein by reference.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this item will be contained in our definitive proxy statement issued in connection with
the 2020 Annual Meeting of Shareholders and is incorporated herein by reference.
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
1. Financial Statements
PART IV
See the Index to Consolidated Financial Statements in Part II, Item 8 of this Form 10-K.
2. Financial Statement Schedules
All schedules have been omitted as the required information is either not required, not applicable or otherwise
included in the Financial Statements and notes thereto.
3. Exhibits
The following list of exhibits includes exhibits submitted with this Form 10-K as filed with the SEC and those
incorporated by reference to other filings
EXHIBIT INDEX
Incorporated by Reference
Exhibit
Exhibit
No.
Exhibit Description
Form
File No.
3.1
Amended and Restated Articles of
10-K
001-34475
Incorporation of Omeros Corporation
No.
3.1
Filing Date
03/31/2010
3.2
Amended and Restated Bylaws of
10-K
001-34475
3.2
03/31/2010
4.1
4.2
Omeros Corporation
Description of Common Stock
Form of Omeros Corporation common
S-1/A 333-148572
4.1
10/02/2009
stock certificate
4.3
Form of Omeros Corporation
8-K
001-34475
10.3
05/19/2016
May 2016 Common Stock Warrant
4.4
Form of Omeros Corporation
8-K
001-34475
10.2
4/13/2018
April 2018 Common Stock Warrant
87
Filed
Herewith
X
4.5
Indenture, dated as of November 15,
2018, between Omeros Corporation
and Wells Fargo Bank, National
Association, as trustee (including the
form of 6.25% Convertible Senior
Notes due 2023).
8-K
001-34475
4.1
11/15/2018
10.1*
Form of Indemnification Agreement
S-1
333-148572
10.1
01/09/2008
entered into between Omeros
Corporation and its directors and
officers
10.2*
2008 Equity Incentive Plan (as
10-K
001-34475
10.6
03/16/2017
amended)
10.3*
Form of Stock Option Award
10-Q
001-34475
10.2
11/07/2013
Agreement under the 2008 Equity
Incentive Plan
10.4*
2017 Omnibus Incentive
8-K
001-34475
10.1
6/11/2019
Compensation Plan (as amended and
restated effective as of June 7, 2019)
10.5*
Form of Stock Option Award
S-8
333-218882
4.4
06/21/2017
Agreement under the 2017 Omnibus
Incentive Compensation Plan
10.6*
Second Amended and Restated
8-K
001-34475
10.1
04/12/2010
10.8*
10.8
10.9*
10.10
Employment Agreement between
Omeros Corporation and Gregory A.
Demopulos, M.D. dated April 7, 2010
Technology Transfer Agreement
between Omeros Corporation and
Gregory A. Demopulos, M.D. dated
June 16, 1994
Technology Transfer Agreement
between Omeros Corporation and
Pamela Pierce, M.D., Ph.D. dated
June 16, 1994
Second Technology Transfer
Agreement between Omeros
Corporation and Gregory A.
Demopulos, M.D. dated December 11,
2001
Second Technology Transfer
Agreement between Omeros
Corporation and Pamela Pierce, M.D.,
Ph.D. dated March 22, 2002
S-1
333-148572
10.14
01/09/2008
S-1
333-148572
10.15
01/09/2008
S-1
333-148572
10.16
01/09/2008
S-1
333-148572
10.17
01/09/2008
88
10.11*
Omeros Corporation Non-Employee
10-Q
001-34475
10.3
08/08/2017
Director Compensation Policy
10.12
Lease dated January 27, 2012 between
Omeros Corporation and BMR-201
Elliott Avenue LLC
8-K
001-34475
10.1
02/01/2012
10.13
First Amendment to Lease dated
10-Q
001-34475
10.2
11/09/2012
November 5, 2012 between Omeros
Corporation and BMR-201 Elliott
Avenue LLC
10.14
Second Amendment to Lease dated
10-K
001-34475
10.18
03/18/2013
November 16, 2012 between Omeros
Corporation and BMR-201 Elliott
Avenue LLC
10.15
Third Amendment to Lease dated
10-K
001-34475
10.18
03/13/2014
October 16, 2013 between Omeros
Corporation and BMR-201 Elliott
Avenue LLC
10.16
Fourth Amendment to Lease dated
10-Q
001-34475
10.3
11/09/2015
September 8, 2015 between Omeros
Corporation and BMR-201 Elliott
Avenue LLC
10.17
Fifth Amendment to Lease dated
10-Q
001-34475
10.1
05/10/2017
September 1, 2016 between Omeros
Corporation and BMR-201 Elliott
Avenue LLC
10.18
Sixth Amendment to Lease dated
10-K
001-34475
10.19
03/01/2019
10.19
10.20
October 18, 2018 between Omeros
Corporation and BMR-201 Elliott
Avenue LLC
Seventh Amendment to Lease dated
April 15, 2019 between Omeros
Corporation and BMR-201 Elliott
Avenue LLC
Eighth Amendment to Lease dated
October 18, 2019 between Omeros
Corporation and BMR-201 Elliott
Avenue LLC
10-Q
001-34475
10.1
08/08/2019
X
10.21†
Exclusive License and Sponsored
S-1/A 333-148572
10.29
09/16/2009
Research Agreement between Omeros
Corporation and the University of
Leicester dated June 10, 2004
89
10.22†
Research and Development Agreement
First Amendment between Omeros
Corporation and the University of
Leicester dated October 1, 2005
S-1
333-148572
10.30
01/09/2008
10.23†
Research and Development Agreement
10-K
001-34475
10.24
03/16/2015
Eighth and Ninth Amendments
between Omeros Corporation and the
University of Leicester dated
March 21, 2012 and September 1,
2013
10.24†
Exclusive License and Sponsored
S-1/A 333-148572
10.31
09/16/2009
Research Agreement between Omeros
Corporation and Medical Research
Council dated October 31, 2005
10.25†
Amendment dated May 8, 2007 to
Exclusive License and Sponsored
Research Agreement between Omeros
Corporation and the Medical Research
Council dated October 31, 2005
10.26†
Funding Agreement between Omeros
Corporation and The Stanley Medical
Research Institute dated December 18,
2006
S-1
333-148572
10.32
01/09/2008
S-1/A 333-148572
10.33
05/15/2009
10.27†
Patent Assignment Agreement
S-1/A 333-148572
10.47
09/16/2009
between Omeros Corporation and
Roberto Ciccocioppo, Ph.D. dated
February 23, 2009
10.28†
First Amendment to Patent
10-K
001-34475
10.28
03/18/2013
Assignment Agreement between
Omeros Corporation and Roberto
Ciccocioppo, Ph.D. effective
December 31, 2010
10.29†
License Agreement between Omeros
Corporation and Daiichi Sankyo
Co., Ltd. (successor-in-interest to
Asubio Pharma Co., Ltd.) dated
March 3, 2010
10-Q
001-34475
10.1
05/12/2010
10.30†
Amendment No. 1 to License
10-Q
001-34475
10.1
05/10/2011
Agreement with an effective date of
January 5, 2011 between Omeros
Corporation and Daiichi Sankyo
Co., Ltd.
90
10.31†
Amendment No. 2 to License
10-Q
001-34475
10.1
05/09/2013
Agreement with an effective date of
January 25, 2013 between Omeros
Corporation and Daiichi Sankyo
Co., Ltd.
10.32†
Exclusive License Agreement between
10-Q
001-34475
10.2
08/10/2010
10.33†
10.34†
10.35†
Omeros Corporation and Helion
Biotech ApS dated April 20, 2010
Platform Development Funding
Agreement between Omeros
Corporation and Vulcan Inc. and its
affiliate dated October 21, 2010
Grant Award Agreement between
Omeros Corporation and the Life
Sciences Discovery Fund Authority
dated October 21, 2010
Commercial Supply Agreement among
Omeros Corporation, Hospira S.p.A.
and Hospira Worldwide, Inc. dated
October 3, 2014
10-K
001-34475
10.44
03/15/2011
10-K
001-34475
10.45
03/15/2011
10-K
001-34475
10.46
03/16/2015
10.36†
First Amendment to Commercial
10-Q
001-34475
10.1
11/09/2015
Supply Agreement dated August 1,
2015 by and between Omeros
Corporation and Hospira
Worldwide, Inc.
10.37
Form of capped call transaction
8-K
001-34475
10.2
11/15/2018
confirmation, dated as of November 8,
2018, by and between Royal Bank of
Canada and Omeros Corporation, in
reference to the 6.25% Convertible
Senior Notes due 2023
10.38
Settlement Agreement, dated
8-K
001-34475
10.1
10/05/2017
October 4, 2017, by and among
Omeros Corporation, Par Sterile
Products, LLC and Par
Pharmaceutical, Inc.
10.39
Settlement Agreement, dated as of
8-K
001-34475
10.1
05/24/2018
May 22, 2018, by and among Omeros
Corporation, Lupin Ltd. and Lupin
Pharmaceuticals, Inc.
10.40
Loan and Security Agreement, dated
as of August 2, 2019, by and between
Omeros Corporation and Silicon
Valley Bank
8-K
001-34475
10.1
08/08/2019
91
10.41††
Master Services Agreement, dated
July 28, 2019, between Omeros
Corporation and Lonza Biologics Tuas
Pte. Ltd.
23.1
Consent of Independent Registered
Public Accounting Firm
31.1
Certification of Principal Executive
Officer Pursuant to Rule 13-14(a) or
Rule 15d-14(a) of the Securities
Exchange Act of 1934 as Adopted
Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
31.2
Certification of Principal Financial
Officer Pursuant to Rule 13-14(a) or
Rule 15d-14(a) of the Securities
Exchange Act of 1934 as Adopted
Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
32.1
Certification of Principal Executive
Officer Pursuant to 18 U.S.C.
Section 1350, as Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act
of 2002
32.2
Certification of Principal Financial
Officer Pursuant to 18 U.S.C.
Section 1350, as Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act
of 2002
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension
Schema Document
101.CAL
Inline XBRL Taxonomy Extension
Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension
Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension
Labels Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension
Presentation Linkbase Document
104.1
Cover Page Interactive Data File,
formatted in Inline XBRL (included in
Exhibit 101)
10-Q
001-34475
10.1
11/12/2019
X
X
X
X
X
X
X
X
X
X
X
X
92
* Indicates management contract or compensatory plan or arrangement.
† Portions of this exhibit are redacted in accordance with a grant of confidential treatment.
†† Certain identified information has been excluded from the exhibit because it both (A) is not material and (B) would
be competitively harmful if publicly disclosed.
ITEM 16. FORM 10-K SUMMARY
Not included.
93
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
OMEROS CORPORATION
/s/ GREGORY A. DEMOPULOS, M.D.
Gregory A. Demopulos, M.D.
President, Chief Executive Officer
and Chairman of the Board of Directors
Dated: March 2, 2020
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the
following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ GREGORY A. DEMOPULOS, M.D.
Gregory A. Demopulos, M.D.
President, Chief Executive Officer and Chairman of
the Board of Directors (Principal Executive Officer)
March 2, 2020
/s/ MICHAEL A. JACOBSEN
Michael A. Jacobsen
/s/ RAY ASPIRI
Ray Aspiri
/s/ THOMAS F. BUMOL, PH.D.
Thomas F. Bumol, Ph.D.
/s/ THOMAS J. CABLE
Thomas J. Cable
Vice President, Finance, Chief Accounting Officer
and Treasurer (Principal Financial Officer and
Principal Accounting Officer)
Director
Director
Director
/s/ PETER A. DEMOPULOS, M.D.
Peter A. Demopulos, M.D.
Director
/s/ ARNOLD C. HANISH
Arnold C. Hanish
Director
/s/ LEROY E. HOOD, M.D., PH.D.
Leroy E. Hood, M.D., Ph.D.
Director
/s/ RAJIV SHAH, M.D.
Rajiv Shah, M.D.
/s/ KURT ZUMWALT
Kurt Zumwalt
Director
Director
94
March 2, 2020
March 2, 2020
March 2, 2020
March 2, 2020
March 2, 2020
March 2, 2020
March 2, 2020
March 2, 2020
March 2, 2020
C O N T A C T S + I N F O R M A T I O N
Transfer Agent and Registrar
Computershare Inc.
P.O. Box 505000
Louisville, KY 40233-5000
Toll Free Number: 866.282.4938 (U.S.)
Outside the U.S.: 201.680.6578
TDD for Hearing Impaired: 800.490.1493 (U.S.)
Outside the U.S.: 781.575.4592
www.computershare.com/investor
Independent Registered Public
Accounting Firm
Ernst & Young LLP
Stock Listing
Omeros’ stock trades on The Nasdaq Global
Market under the symbol OMER. For more
information, please visit www.omeros.com.
SIGNIFICANT EMPLOYEES
Christopher S. Bral, Ph.D.
Vice President, Nonclinical Development
Timothy M. Duffy
Vice President, Business Development
George A. Gaitanaris, M.D., Ph.D.
Vice President, Science
Chief Scientific Officer
Daniel G. Kirby
Vice President, Chief Commercial Officer
Bruce Meiklejohn, Ph.D.
Vice President,
Chemistry, Manufacturing and Controls
Catherine A. Melfi, Ph.D.
Vice President, Regulatory Affairs & Quality Systems
Chief Regulatory Officer
Tina Quinton, J.D., M.S.
Vice President, Patents
J. Steven Whitaker, M.D., J.D.
Vice President, Chief Medical Officer
Corporate Headquarters
Omeros Corporation
The Omeros Building
201 Elliott Avenue West
Seattle, WA 98119
206.676.5000
www.omeros.com
2020 Annual Meeting
The 2020 Annual Meeting of Shareholders of
Omeros Corporation will be held via live
webcast on the Internet on Friday, June 5, 2020,
beginning at 10:00 A.M. (local time), at
www.meetingcenter.io/250382724.
For further information, contact Omeros
Investor Relations.
Investor Relations
Investors can contact Omeros Investor
Relations by email at ir@omeros.com, by
calling 206.676.5000, or by writing to Investor
Relations at Omeros' corporate headquarters.
Copies of Omeros’ Annual Report on Form 10-K
for the fiscal year ended December 31, 2019,
including financial statements, as well as other
Omeros public documents, are available on the
Omeros investor relations website at
investor.omeros.com or by written or
telephonic request to Investor Relations at
Omeros’ corporate headquarters.
EXECUTIVE OFFICERS
Gregory A. Demopulos, M.D.
Chairman and President
Chief Executive Officer
Michael A. Jacobsen
Vice President, Finance
Chief Accounting Officer and Treasurer
Peter B. Cancelmo, J.D.
Vice President,
General Counsel and Secretary
BOARD OF DIRECTORS
Ray Aspiri
Former Chairman of the Board
Tempress Technologies, Inc.
Thomas F. Bumol, Ph.D.
Executive Director
Allen Institute for Immunology
Thomas J. Cable
Vice Chairman of the Board
Washington Research Foundation
Gregory A. Demopulos, M.D.
Chairman and President
Chief Executive Officer
Omeros Corporation
Peter A. Demopulos, M.D.
Cardiologist
Swedish Heart and Vascular Institute
Arnold C. Hanish
Former VP and Chief Accounting Officer
Eli Lilly and Company
Leroy E. Hood, M.D., Ph.D.
Chief Strategy Officer
Institute for Systems Biology
Senior VP and Chief Science Officer
Providence Health & Services
Rajiv Shah, M.D.
President
The Rockefeller Foundation
Former Administrator of the
U.S. Agency for International Development
Kurt Zumwalt
Former Treasurer
Amazon.com
FORWARD-LOOKING STATEMENTS
This annual report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, which are subject to the ‘‘safe harbor’’ created by those sections for such statements. All
statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as
‘‘anticipate,’’ ‘‘believe,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘goal,’’ ‘‘intend,’’ ‘‘likely,’’ ‘‘look forward to,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’
‘‘project,’’ ‘‘should,’’ ‘‘will,’’ ‘‘would’’ and similar expressions and variations thereof. Forward-looking statements are based on
management’s beliefs and assumptions and on information available to management only as of the date of this annual report.
Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons including,
without limitation, the risks, uncertainties and other factors described under the heading ‘‘Risk Factors’’ in this annual report. Given
these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and Omeros
assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.
THE OMEROS BUILDING
201 ELLIOTT AVENUE WEST
SEATTLE, WA 98119
OMEROS.COM