Omeros Corporation Reports First Quarter 2018 Financial Results
– Conference Call Today at
1Q 2018 total and OMIDRIA® revenues were
$1.6 million, compared to $12.3 millionin 1Q 2017; the decrease is the result of the scheduled expiration of OMIDRIA pass-through reimbursement status on January 1, 2018.
The Consolidated Appropriations Act, signed into law in
March 2018, includes a provision granting a two-year pass-through extension, beginning on October 1, 2018, for a small number of drugs including OMIDRIA.
Net loss in 1Q 2018 was
$30.1 million, or $0.62per share. Non-cash expenses for 1Q 2018 were $4.3 million, or $0.09per share. Overall decrease in cash, cash equivalents and short-term investments for the quarter was $10.9 million.
March 31, 2018, the company had cash, cash equivalents and short-term investments available for operations of $72.8 million. An additional $45.0 millionavailable under the company’s existing credit facility is expected to fund on May 18, 2018.
- Patient enrollment began in the OMS721 Phase 3 clinical trial (known as ARTEMIS-IGAN) in patients with Immunoglobulin A (IgA) nephropathy.
- OMS721 was granted breakthrough therapy designation for treatment of patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who have persistent TMA despite modification of immunosuppressive therapy.
Following recent interactions with
FDA, Omerosbelieves that it has a clear path to approval for OMS721 in high-risk HSCT-TMA, intends to continue working closely with FDAto achieve this objective and has begun preparations to submit a Biologics License Application (BLA).
OMIDRIA was added to the Veterans Health Administration National
“During the first quarter of 2018, we made tremendous progress in our
MASP-2 program,” said
First Quarter and Recent Developments
Developments regarding OMS721, Omeros’ lead human monoclonal antibody
in its mannan-binding lectin-associated serine protease-2 (MASP-2)
programs for the treatment of HSCT-TMA, IgA nephropathy, and atypical
hemolytic uremic syndrome (aHUS), include:
Omerosannounced in April 2018that the U.S. Food and Drug Administration( FDA) granted breakthrough therapy designation to OMS721 for the treatment of patients with high-risk HSCT-TMA, specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is the second breakthrough therapy designation for OMS721, which last year received the designation from FDAfor the treatment of IgA nephropathy. Omerosrecently met with FDAto discuss requirements for approval of OMS721 in high-risk HSCT-TMA. Based on that meeting, Omerosbelieves that it has clear paths to both accelerated and full approval of OMS721 in this indication. In addition to the data provided to FDA, the Agency requested that the company further characterize the patients treated with OMS721 – all of whom had high-risk TMA – and compile and submit additional information on the historical control population for the purpose of further comparing outcomes across corresponding patients. FDAalso requested an analysis plan to assess the company’s biomarker data. Should FDAgrant OMS721 accelerated approval for the treatment of high-risk stem cell-TMA patients, the drug would be made commercially available for stem-cell patients with this highly lethal disorder. Concurrently, Omeroswould conduct a confirmatory trial for subsequent full approval. Omerosintends to continue working closely with FDAas the company further compiles all required information with the objective of initiating a rolling BLA submission later this year. In Europe, the company is scheduling meetings with regulatory authorities to discuss plans for submission of an application for conditional marketing authorization for OMS721 in HSCT-TMA.
- In February and April 2018, Omeros reported new results in patients with HSCT-TMA from the ongoing Phase 2 study. The estimated median survival for OMS721-treated patients was an order of magnitude greater than that for a matched historical control (p<0.0001). After study patients had reached an adequate duration of follow-up, further data analysis examined 100-day mortality, an important measure previously used as an approval endpoint in HSCT. That analysis also showed that OMS721-treated patients had improved survival relative to the historical control (53 percent vs 10 percent; p = 0.0002). Biomarkers of disease (i.e., mean platelet count and mean levels of lactate dehydrogenase and haptoglobin), demonstrated statistically significant improvement. Study patients also showed substantial improvement in red blood cell and platelet transfusion requirements.
February 2018, the EMA granted OMS721 orphan drug designation in the treatment of IgA nephropathy. Enrollment in the Phase 3 clinical trial ARTEMIS-IGAN is ongoing.
Recent developments regarding OMIDRIA include:
March 2018, the Consolidated Appropriations Act, 2018 (Consolidated Appropriations Act) was signed into law and included a two-year extension of pass-through reimbursement status for OMIDRIA and a small number of other drugs used during procedures performed on Medicare Part B fee-for-service patients. As a result, OMIDRIA will receive a reinstatement of separate payment beginning October 1, 2018through September 30, 2020.
OMIDRIA was added to the
Veterans Health Administration(VA) National Formulary in April 2018. With its addition to the formulary, the drug is now available in all VA facilities that perform ophthalmic procedures. The initial recommendation is that OMIDRIA be limited to use in high-risk patients as determined by each VA ophthalmic surgeon at his or her discretion.
April 2018, Omerosannounced that the results of four “real-world” clinical studies were presented at the American Society of Cataract and Refractive Surgeryand American Society of Ophthalmic AdministratorsAnnual Meeting held in Washington, D.C.The studies demonstrate significant benefits of OMIDRIA to both patients and surgeons across routine and complex cataract surgery cases performed in high-volume surgery centers, with and without femtosecond laser.
April 2018, the company’s credit facility with CRG was amended to eliminate the revenue and market capitalization covenants with respect to the twelve-month period ending on December 31, 2018and to reduce the market capitalization threshold for future periods to three times the aggregate principal amount of loans outstanding (excluding any payment-in-kind loans) on the applicable determination date. Omerosissued five-year warrants to the lenders for up to 200,000 shares of the company’s common stock at an exercise price per share of $23.00, which represents approximately a 70-percent premium to the closing price of Omeros’ common stock at that time. In addition, the company has requested the $45.0 millioncurrently available under the CRG credit facility and expects funding to occur on May 18, 2018.
For the quarter ended
Total costs and expenses for the three months ended
For the three months ended
Conference Call Details
Omeros’ management will host a conference call to discuss the financial
results and to provide an update on business activities. The call will
be held today at
To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select “Events” under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.
This press release 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,” “objective,” “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 press release. Omeros’ actual results could differ
materially from those anticipated in these forward-looking statements
for many reasons, including, without limitation, risks associated with
product commercialization and commercial operations, unproven
preclinical and clinical development activities, regulatory oversight,
intellectual property claims, competitive developments, litigation, and
the risks, uncertainties and other factors described under the heading
“Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with
|UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share data)|
|Three Months Ended|
|Product sales, net||$||1,588||$||12,257|
|Costs and expenses:|
|Cost of product sales||203||271|
|Research and development||18,140||12,240|
|Selling, general and administrative||10,934||12,471|
|Total costs and expenses||29,277||24,982|
|Loss from operations||(27,689||)||(12,725||)|
|Basic and diluted net loss per share||$||(0.62||)||$||(0.34||)|
Weighted-average shares used to compute basic and diluted net loss per share
|UNAUDITED CONSOLIDATED BALANCE SHEET DATA|
|March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||72,814||$||83,749|
|Total current liabilities||24,630||26,307|
|Notes payable and lease financing obligations, net||85,550||84,607|
|Total shareholders’ deficit||(29,215||)||(2,814||)|
Cook Williams Communications, Inc.
Jennifer Cook Williams, 360-668-3701
Investor and Media Relations