Omeros Corporation Reports Fourth Quarter and Year-End 2017 Financial Results
Conference Call Today at
4Q 2017 total and OMIDRIA® revenues were
$13.8 million, a decrease of 36.5 percent from 3Q 2017, despite the fact that unit pricing and the total number of vials sold to ASCs and hospitals was unchanged from 3Q 2017. Under the company’s accounting policies, it is not able to recognize a majority of the revenue related to OMIDRIA inventories held by wholesalers at December 31because of uncertainty around OMIDRIA reimbursement following expiration of pass-through status on January 1, 2018and resulting reduced first quarter sell-through. In addition, a $2.4 millioncharge to revenue was recorded in the fourth quarter for vials that the company reserved for returns by the ASCs and hospitals anticipated in 2018.
Units sold to ASCs and hospitals by wholesalers (sell-through) for
November 2017were 18 percent greater than the corresponding period in 3Q.
Total year 2017 OMIDRIA revenues were
$64.8 million, a 56.4 percent increase over 2016.
Net loss in 4Q 2017 was
$16.6 million, or $0.34per share, again reflecting the inability to recognize wholesaler inventories at year-end. Net loss for the full year of 2017 was $53.5 million, or $1.17per share. Non-cash expenses for 4Q and the full year of 2017 were $4.5 million, or $0.09per share, and $17.4 million, or $0.38per share, respectively. The reduction in cash, cash equivalents and short-term investments from 3Q to 4Q was $3.1 million.
December 31, 2017, the company had cash, cash equivalents and short-term investments available for operations of $83.7 millionwith an additional $17.1 millionin accounts receivable. The company has the ability to borrow an additional $45.0 millionfrom existing lenders through May 20, 2018.
- Released compelling survival data and initiated a Phase 3 program for OMS721 in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA).
- Opened enrollment in OMS721 Phase 3 trial for Immunoglobulin A (IgA) nephropathy.
Granted orphan drug designation for OMS721 in the treatment of IgA
European Medicines Agency(EMA).
“The company’s progress during the fourth quarter of 2017 continued to
build on our accomplishments earlier in the year,” said Gregory A.
Demopulos, M.D., chairman and chief executive officer of
Fourth Quarter and Recent Developments
Recent developments regarding OMIDRIA include:
OMIDRIA pass-through status expired on
January 1, 2018as scheduled, and payment for the product is included as part of the packaged payment for the associated procedure for Medicarepatients. Based on first quarter 2018 data to date, Omerosbelieves that a substantial majority of facilities that were using OMIDRIA are awaiting resolution regarding reimbursement by the Centers for Medicare and Medicaid Services(CMS), or the company’s decision to implement an alternative sales strategy, and, therefore, sales to wholesalers during this period have been adversely affected, and Omerosexpects this trend will likely continue until such uncertainty is resolved. Both legislative and administrative means are being pursued to obtain permanent separate payment or similar reimbursement for OMIDRIA and/or to extend the pass-through reimbursement period from three to five years.
In December, the
FDAapproved Omeros’ supplemental new drug application (sNDA) following review of efficacy and safety data from a pediatric clinical trial, expanding the indication for OMIDRIA to include use in pediatric patients (ages birth through 17 years old). The FDAalso granted OMIDRIA an additional six months of U.S. market exclusivity, which is attached to the term of the drug’s patents listed in FDA’s Orange Book.
- OMIDRIA pass-through status expired on
Developments regarding OMS721, Omeros’ lead human monoclonal antibody
in its mannan-binding lectin-associated serine protease-2 (MASP-2)
programs for the treatment of IgA nephropathy, HCT-TMA and atypical
hemolytic uremic syndrome (aHUS), include:
February 2018, Omerosreported new results from the ongoing Phase 2 study of OMS721 evaluating patients with HCT-TMA. The data, from a total of 19 patients, demonstrate an increase in estimated median overall survival in HCT-TMA patients treated with OMS721 compared to a matched historical control (347 days vs. 21 days, respectively, by Kaplan-Meier analysis; p < 0.0001 by log-rank test). In addition to and consistent with the survival data reported, updated assessments of platelet count, lactate dehydrogenase (LDH) and haptoglobin – all markers of TMA activity – continued to demonstrate clinically meaningful and statistically significant improvements in the HCT-TMA patients treated with OMS721.
- Significant improvement in transfusion requirements was seen in the cohort of HCT-TMA patients referenced above. Eight of the 19 patients were receiving significant red blood cell and platelet transfusions at the time of study entry. The transfusions were either stopped completely or markedly reduced in seven of the eight patients. The eighth patient had ongoing acute myeloid leukemia – a malignancy of bone marrow characterized by severe red cell anemia and low production of platelets – this patient received only two doses of OMS721, discontinued the study and died shortly thereafter.
The company is scheduled to meet with
FDAand is requesting meetings with regulatory bodies in the EU to discuss the most expeditious approval path, including accelerated and conditional approvals, for OMS721 in HCT-TMA.
February 2018, the EMA granted OMS721 orphan drug designation in the treatment of IgA nephropathy. Enrollment in the Phase 3 IgA nephropathy trial is underway.
Omerosextended the borrowing capacity under its existing credit facility allowing the company to borrow, at its sole discretion, up to $45.0 millionthrough May 20, 2018subject only to customary closing conditions.
Fourth Quarter 2017
For the quarter ended
Total operating costs and expenses for the three months ended
For the three months ended
Full Year 2017
Revenues for the full year 2017 were
Total operating costs and expenses for the year ended
For the full year 2017,
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,” “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||$||13,760||$||12,905||$||64,826||$||41,444|
|Costs and expenses:|
|Cost of product sales||466||380||1,078||1,412|
|Research and development||15,387||12,542||55,599||50,699|
|Selling, general and administrative||12,028||11,840||52,044||43,782|
|Total costs and expenses||27,881||24,762||108,721||95,893|
|Loss from operations||(14,121||)||(11,857||)||(43,895||)||(54,276||)|
|Loss on early extinguishment of debt||—||(5,595||)||—||(5,595||)|
|Basic and diluted net loss per share||$||(0.34||)||$||(0.45||)||$||(1.17||)||$||(1.65||)|
Weighted-average shares used to compute basic and diluted net loss per share
|UNAUDITED CONSOLIDATED BALANCE SHEET DATA|
|December 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||83,749||$||45,331|
|Total current liabilities||26,307||16,071|
|Notes payable and lease financing obligations, net||84,117||79,512|
|Total shareholders’ deficit||(2,814||)||(37,447||)|
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Cook Williams Communications, Inc.
Jennifer Cook Williams, 360-668-3701
Investor and Media Relations