Welcome!

News Feed Item

Omeros Corporation Reports Second Quarter 2014 Financial Results

-- FDA Approval of Omidria™ Received on May 30, 2014 -

SEATTLE, Aug. 11, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced financial results and highlights for the second quarter of 2014, which include:

  • 2Q 2014 net loss of $18.0 million, or $0.53 per share, which included $2.5 million ($0.07 per share) of non-cash expenses
  • Operating expenses of $17.3 million, primarily related to preparing for U.S. commercial launch of Omidria and advancing OMS824 and OMS721 clinical programs
  • U.S. Food and Drug Administration (FDA) approval of Omidria(phenylephrine and ketorolac injection) 1%/0.3% for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain
  • FDA clearance of Investigational New Drug (IND) application for Phase 2 clinical trial evaluating OMS721 in thrombotic microangiopathies (TMAs) and initiated Phase 2 trial

"Obtaining U.S. marketing approval for Omidria is a tremendous accomplishment for Omeros," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "It marks a pivotal point in our transition to a commercial company, and we are continuing preparations for a planned U.S. product launch in the fourth quarter of 2014. In that same time frame, we also expect to receive a decision on the EU marketing application for Omidria. While we remain focused on the market launch of Omidria, we continue to advance the rest of our pipeline, including our MASP-2 inhibitor OMS721 and PDE10 inhibitor OMS824 Phase 2 clinical programs in patients with TMAs and Huntington's, respectively. We expect preliminary data from each of those Phase 2 trials later this year."

Second Quarter and Recent Highlights

  • FDA granted marketing approval to Omidria (phenylephrine and ketorolac injection) 1%/0.3% on May 30, 2014 for use during cataract surgery or ILR to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. The only post-marketing commitment required is the previously agreed upon study of Omidria for use in pediatric patients, which, if successfully completed according to FDA's Written Request, makes Omidria eligible for an additional six months of marketing exclusivity in the U.S. The company expects first patient enrollment in this trial in the latter part of the third quarter.
  • Continued preparations for the commercial launch of Omidria in the U.S., including hiring sales and marketing management teams and contracting for field sales representatives to call on surgeons, hospitals and ambulatory surgery centers beginning in August 2014. The company expects to begin commercial sales of Omidria in the fourth quarter of 2014.
  • Announced that the FDA cleared Omeros' IND application to evaluate OMS721 for the inhibition of complement-mediated TMAs in a Phase 2 clinical trial, which is currently underway.

Financial Results
For the quarter ended June 30, 2014, Omeros reported a net loss of $18.0 million, or $0.53 per share. This compares to a net loss of $13.6 million or $0.48 per share, for the same period in 2013. Noncash expenses were $2.5 million ($0.07 per share) for the quarter ended June 30, 2014 and $2.2 million ($0.08 per share) for the same period in 2013.

Operating expenses for the three months ended June 30, 2014 were $17.3 million compared to $13.3 million for the same period in 2013. The increase was primarily related preparing for the U.S. commercial launch of Omidria later this year and to manufacturing of material and clinical costs associated with the Phase 2 clinical trials evaluating OMS721 in TMAs and OMS824 in Huntington's disease.

Revenue for the quarter ended June 30, 2014 was $45,000 compared to $140,000 for the same period in 2013. This decrease was due to a reduction of activity on NIH grant projects, which resulted in lower revenue being recognized.

At June 30, 2014, Omeros had cash and cash equivalents and short-term investments of $37.5 million.

About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the Company's first drug product, Omidria (phenylephrine and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. Omeros is completing preparations for a planned U.S. product launch in the fourth quarter of 2014. Omidria is currently under review for marketing approval by the European Medicines Agency. Omeros also has six clinical-stage development programs focused on complement-related thrombotic microangiopathies, Huntington's disease, schizophrenia, and cognitive impairment; on addictive and compulsive disorders; and on preventing problems associated with surgical procedures. Omeros also has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.

Forward-Looking Statements
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," "look forward to," "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. 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 effectiveness of Omidria sales and marketing efforts, Omidria market acceptance, product pricing and reimbursement, Omeros' ability to obtain regulatory approval for its Marketing Authorization Application in the EU for the commercialization of Omidria, Omeros' unproven preclinical and clinical development activities, regulatory oversight, product commercialization, 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 the Securities and Exchange Commission on August 11, 2014. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

 

OMEROS CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)




Three Months Ended


Six Months Ended



June 30,


June 30,



2014


2013


2014


2013



(unaudited)


(unaudited)

Revenue

$               45


$             140


$              145


$              1,235

Operating expenses:









Research and development

12,407


9,564


24,424


16,691

General and administrative

4,855


3,736


8,622


7,724

Total operating expenses

17,262


13,300


33,046


24,415

Loss from operations

(17,217)


(13,160)


(32,901)


(23,180)

Investment income

5


2


7


8

Interest expense

(939)


(589)


(1,611)


(1,176)

Other income (expense), net

160


155


(128)


267

Net loss

$     (17,991)


$     (13,592)


$     (34,633)


$         (24,081)

Basic and diluted net loss per share

$         (0.53)


$         (0.48)


$          (1.07)


$              (0.89)

Weighted-average shares used to compute 








basic and diluted net loss per share

33,933,356


28,199,739


32,415,198


27,053,946










OMEROS CORPORATION

CONSOLIDATED BALANCE SHEET DATA

(In thousands)







June 30,


December 31,







2014


2013







(unaudited)











Cash and cash equivalents and short-term investments


$        37,460


$            14,101

Total assets


40,993


16,535

Total notes payable


32,370


20,498

Total current liabilities


12,170


11,873

Accumulated deficit


(289,006)


(254,373)

Total shareholders' deficit


(10,611)


(18,384)






 

SOURCE Omeros Corporation

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that Technologic Systems Inc., an embedded systems solutions company, will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Technologic Systems is an embedded systems company with headquarters in Fountain Hills, Arizona. They have been in business for 32 years, helping more than 8,000 OEM customers and building over a hundred COTS products that have never been discontinued. Technologic Systems’ pr...
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
The taxi industry never saw Uber coming. Startups are a threat to incumbents like never before, and a major enabler for startups is that they are instantly “cloud ready.” If innovation moves at the pace of IT, then your company is in trouble. Why? Because your data center will not keep up with frenetic pace AWS, Microsoft and Google are rolling out new capabilities In his session at 20th Cloud Expo, Don Browning, VP of Cloud Architecture at Turner, will posit that disruption is inevitable for c...
SYS-CON Events announced today that Cloudistics, an on-premises cloud computing company, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloudistics delivers a complete public cloud experience with composable on-premises infrastructures to medium and large enterprises. Its software-defined technology natively converges network, storage, compute, virtualization, and management into a ...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
What if you could build a web application that could support true web-scale traffic without having to ever provision or manage a single server? Sounds magical, and it is! In his session at 20th Cloud Expo, Chris Munns, Senior Developer Advocate for Serverless Applications at Amazon Web Services, will show how to build a serverless website that scales automatically using services like AWS Lambda, Amazon API Gateway, and Amazon S3. We will review several frameworks that can help you build serverle...
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 20th Cloud Expo, which will take place on June 6-8, 2017 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 add...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...
SYS-CON Events announced today that CrowdReviews.com has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users that have experienced products and services first-hand and have an interest in letting other potential buyers...
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTrend processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.