Omeros Corporation Reports Fourth Quarter and Year-End 2012 Financial Results

Omeros Corporation Reports Fourth Quarter and Year-End 2012 Financial Results

PR Newswire

SEATTLE, March 18, 2013

SEATTLE, March 18, 2013 /PRNewswire/ --Omeros Corporation (NASDAQ: OMER), a
clinical-stage biopharmaceutical company committed to discovering, developing
and commercializing products targeting inflammation, coagulopathies and
disorders of the central nervous system, today announced financial results for
the fourth quarter and year ended December 31, 2012.

Financial Results

Total operating expenses for the three months ended December 31, 2012 were
$9.1 million, compared to $11.0 million for the same period in 2011. Omeros
received a $3.95 million payment from its insurer during the 2012 period as
reimbursement for an expense recognized by Omeros in the third quarter of
2012. Excluding this reimbursement, Omeros' operating expenses increased
during the 2012 period related to advancing its MASP-2 program toward the
clinic, marketing expenses in connection with the planned 2014 commercial
launch of OMS302, and increased legal costs and employee compensation,
including non-cash stock-based compensation. These increases were partially
offset by lower expenses related to Omeros' OMS302 and OMS103HP Phase 3
clinical programs and its PDE10, PDE7 and Plasmin programs.

Total operating expenses for the year ended December 31, 2012 were $42.9
million, compared to $31.9 million in 2011. The increase was primarily due to
higher expenses related to Omeros' OMS302 Phase 3 clinical program and
marketing costs tied to the drug's planned 2014 commercial launch, advancing
its PDE10 and MASP-2 programs into and toward the clinic, respectively, the
Company's GPCR program, and increased legal costs and employee compensation,
including non-cash stock-based compensation. These increases were partially
offset by lower expenses in Omeros' OMS103HP program and in several of its
preclinical programs, including its PDE7 and Plasmin programs.

For the quarter ended December 31, 2012, Omeros reported a net loss of $7.7
million, or $0.30 per share, compared to a net loss of $10.2 million, or $0.46
per share, for the same period in 2011. For the year ended December 31, 2012,
Omeros reported a net loss of $38.4 million, or $1.59 per share, compared to a
net loss of $28.5 million, or $1.29 per share, in 2011.

At December 31, 2012, Omeros had cash and cash equivalents and short-term
investments of $22.4 million. Omeros expects that, taking into account its
at-the-market equity facility with MLV & Co. LLC and its committed equity line
financing facility with Azimuth Opportunity Ltd., it has sufficient resources
to fund anticipated operating expenses, capital expenditures and note payments
for at least the next 12 months.

"In 2012, our lead program, OMS302 for lens replacement surgery, completed two
successful Phase 3 clinical trials – we are preparing to submit the NDA and
MAA in the coming months and are planning the drug's commercial launch in
2014," said Gregory A. Demopulos, M.D., chairman and chief executive officer
of Omeros. "OMS103HP, our product for arthroscopic surgery, delivered
statistically significant and clinically important pain reduction in a Phase 3
clinical trial and will enter its next pivotal Phase 3 trial later this year.
In addition, we are planning to report data soon from our PDE10 Phase 1
program for schizophrenia and cognitive disorders, and our MASP-2 and PDE7
programs are on track to enter the clinic this year. All of these programs,
together with our GPCR program and the rest of our pipeline, provide us
multiple opportunities for success in 2013."

Fourth Quarter Highlights

  oAnnounced the identification of compounds that interact selectively with
    four additional orphan G protein-coupled receptors (GPCRs), bringing the
    total number of orphans GPCRs unlocked by Omeros to 46, representing
    approximately 60 percent of the Class A orphan GPCRs. These four orphans
    – GPR65/TDAG8, GPR82, MRGE and MRGF – are linked to a series of important
    indications, including several types of cancer and inflammatory disorders,
    such as asthma (GPR65/TDAG8), appetite and body weight (GPR82) and pain
    (MRGE and MRGF). Omeros also recently announced its ability to unlock
    Class B orphan GPCRs.

  oReported positive data from its second pivotal Phase 3 clinical trial
    evaluating OMS302 in patients undergoing intraocular lens replacement
    surgery. OMS302 met its co-primary endpoints by demonstrating
    statistically significant (p<0.00001) maintenance of intraoperative
    mydriasis (pupil dilation) and statistically significant (p=0.0002)
    reduction of pain in the early postoperative period. Now with positive
    data from both trials in the OMS302 Phase 3 clinical program, Omeros plans
    to submit a New Drug Application with the U.S. Food and Drug
    Administration in the first half of 2013 and a Marketing Authorization
    Application with the European Medicines Agency in mid-2013. Omeros is
    building its marketing and sales capabilities in expectation of OMS302's
    planned commercial launch in 2014.

  oAnnounced promising data from the single-ascending-dose (SAD) study
    portion of its Phase 1 clinical trial evaluating OMS824, the lead compound
    in Omeros' phosphodiesterase 10 (PDE10) program for schizophrenia and
    cognitive disorders. In this SAD study, OMS824 was well tolerated and
    demonstrated linear pharmacokinetics, a long half-life consistent with
    once daily dosing and good systemic exposure that resulted in the expected
    pharmacological effects in healthy subjects. With these encouraging data,
    Omeros advanced OMS824 to the next stage of the Phase 1 clinical program –
    the evaluation of multiple-ascending dosing (MAD) of the compound. Omeros
    expects to report data from this MAD trial in the near future.

  oCompleted the first Phase 3 clinical trial comparing OMS103HP to vehicle
    control in 344 patients undergoing arthroscopic partial meniscectomy
    surgery. The pre-specified primary endpoint was the Symptoms Subscale of
    the KOOS – a patient-reported measure that is comprised of questions about
    knee swelling, clicking, catching and stiffness. In addition, pain
    measured in the early postoperative period was a pre-specified secondary
    endpoint. Although the Symptoms Subscale of the KOOS did not reach
    statistical significance, OMS103HP achieved statistically significant
    (p=0.0003) reduction of postoperative pain. The pain reduction data were
    similar in magnitude to those in the Phase 2 clinical trial. Omeros
    expects to conduct two concurrent Phase 3 clinical trials with reduction
    of early postoperative pain as the pre-specified primary endpoint and to
    begin enrolling patients in the first of these two planned trials in the
    first half of 2013. Each of these two additional Phase 3 clinical trials
    will enroll substantially fewer subjects than were required for the first
    Phase 3 trial assessing KOOS as the primary endpoint given the increased
    statistical power associated with reduction in early postoperative pain
    shown in the Phase 2 and first Phase 3 meniscectomy clinical trials.

About Omeros Corporation

Omeros is a clinical-stage biopharmaceutical company committed to discovering,
developing and commercializing products targeting inflammation, coagulopathies
and disorders of the central nervous system. The Company's most clinically
advanced product candidates, OMS302 for lens replacement surgery and OMS103HP
for arthroscopy, are derived from its proprietary PharmacoSurgery™ platform
designed to improve clinical outcomes of patients undergoing a wide range of
surgical and medical procedures. Omeros has five clinical development
programs. Omeros may also have the near-term capability, through its GPCR
program, to add a large number of new drug targets and their corresponding
compounds to the market. Behind its clinical candidates and GPCR platform,
Omeros is building a diverse pipeline of protein and small-molecule
preclinical programs targeting inflammation, coagulopathies and central
nervous system disorders.

Forward-Looking Statements

This press release contains forward-looking statements as defined within the
Private Securities Litigation Reform Act of 1995, which are subject to the
"safe harbor" created by those sections. These statements include, but are not
limited to, Omeros' expectations that it has sufficient resources to fund
operations for at least the next 12 months; that it will submit a New Drug
Application and Marketing Authorization Application for OMS302 in 2013; that
it will be able to market and sell OMS302 in 2014; when it will be able to
announce data from its PDE10 Phase 1 program; that it will advance its MASP-2
and PDE7 programs into this clinic this year; that it will conduct two
additional Phase 3 clinical trials evaluating OMS103HP, with enrollment in the
first trial beginning in the first half of 2013; and that Omeros may have
capability, through its GPCR program, to add a large number of new drug
targets and their corresponding compounds to the market. 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,
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 Securities
and Exchange Commission on March 18, 2013. 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 publicly, 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       Twelve Months Ended
                           December 31,             December 31,
                           2012          2011       2012         2011
                           (unaudited)
Revenue                    $        $      $       $      
                           1,583         1,143       6,022     4,524
Operating expenses:
Research and development   9,354         8,895      31,922       23,718
General and administrative 3,715         2,095      10,985       8,216
Litigation settlement      -             -          3,953        -
Litigation recovery        (3,953)       -          (3,953)      -
Total operating expenses   9,116         10,990     42,907       31,934
Loss from operations       (7,533)       (9,847)    (36,885)     (27,410)
Investment income          8             11         40           51
Interest expense           (369)         (536)      (1,729)      (1,884)
Other income, net          160           171        130          697
Net loss                   $         $        $       $    
                           (7,734)       (10,201)  (38,444)     (28,546)
Basic and diluted net loss $       $      $       $      
per share                  (0.30)        (0.46)      (1.59)    (1.29)
Weighted-average shares
used to compute
basic and diluted net loss 25,886,586    22,378,753 24,155,690   22,212,351
per share
OMEROS CORPORATION
CONSOLIDATED BALANCE SHEET DATA
(In thousands)
                                                    December 31, December31,
                                                    2012         2011
Cash and cash equivalents and short-term            $       $      
investments                                          22,350     24,570
Total assets                                        26,575       26,982
Total notes payable                                 20,103       19,446
Total current liabilities                           9,318        18,985
Accumulated deficit                                 (214,577)    (176,133)
Total shareholders' (deficit) equity                (6,531)      (5,554)



SOURCE Omeros Corporation

Contact: Jennifer Cook Williams, Cook Williams Communications, Inc., Investor
and Media Relations, +1-360-668-3701, jennifer@cwcomm.org