Omeros Corporation Reports Fourth Quarter and Year-End 2018 Financial Results
– Conference Call Today at
4Q 2018 total and OMIDRIA® revenues were
$22.0 million, Omeros’ highest revenue quarter to date. This compares to $4.6 millionin 3Q 2018 and $13.8 millionin the prior year fourth quarter. The increase from the prior periods reflects strong demand for OMIDRIA from ambulatory surgery centers (ASCs) and hospitals following reinstatement of pass-through reimbursement for OMIDRIA on October 1, 2018.
Units sold by wholesalers to ASCs and to hospitals (sell-through) as
well as the number of purchasing hospital accounts for the fourth
quarter 2018 each also represent a record high. The annualized run
rate of weekly net sales in December was approximately
Full year 2018 OMIDRIA revenues were
$29.9 million, a 53.9 percent decrease from the prior year. The decrease in OMIDRIA revenues in 2018 was primarily attributable to the lack of separate payment for OMIDRIA under Medicare Part B from January 1, 2018through September 30, 2018.
Net loss in 4Q 2018 was
$23.5 million, or $0.48per share. Net loss for the full year 2018 was $126.8 million, or $2.61per share. Non-cash expenses for 4Q and the full year of 2018 were $4.9 million, or $0.10per share, and $18.7 million, or $0.39per share, respectively.
December 31, 2018, the company had cash, cash equivalents and short-term investments available for operations of $60.5 million.
Announced a streamlined plan for submission of a Biologics License
Application for breakthrough therapy-designated narsoplimab in the
treatment of HSCT-TMA following a meeting with
FDA, which eliminated the need for a historical control, confirmed the appropriateness of a rolling submission and allows for not only accelerated approval but also full approval, with the determination to be made based on the submitted data.
Reported positive data from patients in the second cohort of the Phase
2 IgA nephropathy trial. The data demonstrated that eGFR measurements
remained stable, consistent with preservation of renal function and
that reductions in proteinuria were consistent in magnitude to those
in the first cohort of the Phase 2 trial, with improvements seen of
greater than 50 to approximately 70 percent. A meeting with
FDAresulted in revisions to the ongoing Phase 3 ARTEMIS-IGAN trial that are beneficial to the program.
“We’re pleased with the record OMIDRIA sales in the fourth quarter,
which, together with stronger than historical demand for the product in
January and February, form the basis for our expectations of substantial
growth through 2019,” said
Fourth Quarter and Recent Developments
Recent developments regarding OMIDRIA include the following:
Total revenues from OMIDRIA net sales reported in the fourth
$22.0 million, Omeros’ highest quarterly revenue mark to date. This represents a 59 percent increase year-over-year compared to fourth quarter 2017, the last quarter before losing pass-through status on January 1, 2018.
In the fourth quarter of 2018, “sell through” – the number of
units sold by wholesalers to ASCs and to hospitals during the
quarter – was also the highest for any quarter of OMIDRIA sales to
date. As a result, Omeros’ annualized run rate of weekly net sales
December 2018was approximately $100 million.
- Total revenues from OMIDRIA net sales reported in the fourth quarter were
Recent developments regarding narsoplimab (formerly known as OMS721),
Omeros’ lead human monoclonal antibody targeting mannan-binding
lectin-associated serine protease-2 (MASP-2) in Phase 3 clinical
programs for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA),
Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic
syndrome (aHUS), include the following:
January 2019, Omerosannounced a finalized clinical plan for submission and approval of narsoplimab in IgA nephropathy. At a meeting with FDAto discuss Omeros’ Phase 3 clinical program in this indication, it was confirmed that the Phase 3 trial’s primary endpoint of assessment of proteinuria would be extended from 24 to 36 weeks, as requested by the company, to allow for additional narsoplimab dosing, if needed. These beneficial changes to the program continue to provide a path to accelerated, or even regular (full), approval based on those 36-week proteinuria data in either (i) the entire patient population (patients with baseline proteinuria greater than 1 gm/24 hours) or (ii) the high-risk subpopulation (those with baseline proteinuria of at least 2 gm/24 hours).
January 2019, Omerosannounced additional data from the total of eight IgA nephropathy patients in the second cohort of its Phase 2 trial who entered the extended follow-up period, all of whom received narsoplimab treatment during that period. Consistent with earlier positive results, the data showed at the most recent observation point for each patient: (i) estimated glomerular filtration rate (eGFR) measurements remaining stable, consistent with preservation of renal function; (ii) a 61 percent median reduction in proteinuria from baseline (across all eight patients, assessed at 31 weeks to 54 weeks post-baseline); (iii) five out of the eight patients achieving greater than 50 percent proteinuria reductions (median reduction of 65 percent), with two of those five having received their last narsoplimab administration five months earlier; and (iv) across the first (four patients) and second cohorts, a total of nine of 12 patients achieving greater than 50 percent reductions in proteinuria (median reduction of 65 percent).
February 2019, Omerosannounced a streamlined plan for submission of a Biologics License Application (BLA) for narsoplimab in the treatment of HSCT-TMA. Omerosrecently met with FDAand agreed that a response-based analysis is the most appropriate and expeditious assessment for inclusion in a BLA for this indication, eliminating the need for a historical control. Data from patients already in the company’s ongoing Phase 2 single-arm narsoplimab trial in HSCT-TMA will form the clinical basis for submission of the BLA. Survival assessments will now be secondary endpoints. FDAalso confirmed that a rolling BLA submission is appropriate in this indication. This confirmation enables Omerosto submit first the non-clinical sections of the BLA, which, as planned, were written in late 2018. FDAfurther indicated that it will consider not only accelerated approval but also regular (full) approval for narsoplimab in stem-cell TMA, with the determination to be made based on the submitted data.
October 2018, the FDAgranted narsoplimab orphan drug designation in the treatment of HSCT-TMA.
Fourth Quarter 2018
For the quarter ended
Total operating costs and expenses for the three months ended
For the three months ended
Full Year 2018
Revenues for the full year 2018 were
Total operating costs and expenses for the year ended
For the full year 2018,
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.
Omeros is 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. The
company’s drug product OMIDRIA® (phenylephrine and ketorolac
intraocular solution) 1% / 0.3% is marketed for use during cataract
surgery or intraocular lens (IOL) replacement to maintain pupil size by
preventing intraoperative miosis (pupil constriction) and to reduce
postoperative ocular pain. In the
Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on complement-associated thrombotic microangiopathies, complement-mediated glomerulonephropathies, cognitive impairment and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
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,” “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 Annual Report on Form 10-K filed with the
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Product sales, net||$||22,017||$||13,760||$||29,868||$||64,826|
|Costs and expenses:|
|Cost of product sales||157||466||512||1,078|
|Research and development||25,446||15,387||89,860||55,599|
|Selling, general and administrative||14,888||12,028||51,718||52,044|
|Total costs and expenses||40,491||27,881||142,090||108,721|
|Loss from operations||(18,474||)||(14,121||)||(112,222||)||(43,895||)|
|Loss on early extinguishment of debt||(12,993||)||—||(12,993||)||—|
|Loss before income taxes||(36,463||)||(16,551||)||(139,686||)||(53,481||)|
|Income tax benefit||12,929||—||
|Basic and diluted net loss per share||$||(0.48||)||$||(0.34||)||$||(2.61||)||$||(1.17||)|
Weighted-average shares used to compute basic and diluted net loss per share
UNAUDITED CONSOLIDATED BALANCE SHEET DATA
|December 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||60,498||$||83,749|
|Total current liabilities||37,356||26,307|
Notes payable and lease financing obligations, net
|Unsecured convertible senior notes, net||148,981||—|
|Total shareholders’ deficit||100,156||2,814|
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Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations