SEATTLE, Nov. 9, 2015 /PRNewswire/ -- Omeros Corporation
(NASDAQ: OMER), a biopharmaceutical company committed to
discovering, developing and commercializing both 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 recent highlights and developments
as well as financial results for the third quarter of 2015, which
include:
- Omidria® (phenylephrine and ketorolac injection) 1%
/ 0.3% units shipped by wholesalers ("sell-through") during Q3
increased 71% from prior quarter with no change to net revenue per
vial sold from prior quarter
- Revenues of $3.3 million,
$3.2 million of which resulted from
net product sales of Omidria with minimal quarter-end wholesaler
inventory levels
- Net loss of $19.9 million, or
$0.53 per share, which included
$2.7 million ($0.07 per share) of non-cash expenses for the
three months ended September 30,
2015
- Converting Omidria sales force from a contracted to an in-house
organization
- Received Fast Track Designation from FDA for OMS721 in the
treatment of aHUS and reported additional positive data in the
OMS721 Phase 2 clinical trial in patients with thrombotic
microangiopathies (TMAs)
- Positive data in a patient with hematopoietic stem cell
transplant-related TMA treated with OMS721; currently expanding
clinical trials to include IgA nephropathy and other
complement-related renal disorders
- Resuming previously suspended OMS824 Huntington's clinical
program following review of submitted data by and authorization
from FDA
"The clinical acceptance of Omidria is strong and, throughout
the third quarter, we continue to expand broadly reimbursement for
Omidria across both government and commercial payers," said
Gregory A. Demopulos, M.D., chairman
and chief executive officer of Omeros. "With the fourth-quarter
introduction of OMIDRIAssure™, we have now expanded
access to all cataract surgery patients and have ensured that
physicians and facilities can provide the benefits of Omidria to
their patients without coverage or reimbursement concerns.
Quarterly and monthly unit-sales growth rates are high and that
trend has continued into the fourth quarter, with Omidria sales
revenue now more than covering Omidria-related sales, marketing and
manufacturing costs and providing funding for pipeline development.
OMS721 has continued to generate positive data in the Phase 2 TMA
program, and we are expanding clinical indications beginning with
IgA nephropathy and then moving to additional lectin-mediated
disorders. With Omidria sales increasing, the OMS721 program
expanding, OMS824 headed back to the clinic and the rest of the
pipeline advancing, the rest of this year and 2016 promise to be
exciting."
Third Quarter and Recent Highlights and Developments
- Omeros is in the process of hiring as employees field sales
representatives currently supplied by Ventiv Commercial Services,
LLC (inVentiv), effective January 1,
2016, and will continue to receive back-office sales
management and systems support from inVentiv on a month-to-month
basis.
- OMS721 received Fast Track Designation from the FDA for the
treatment of patients with atypical hemolytic uremic syndrome
(aHUS). The FDA's Fast Track program facilitates the development of
drugs intended to treat serious or life-threatening conditions and
that have the potential to address unmet medical needs.
- In August 2015, Omeros announced
positive data from the mid- and high-dose cohorts in the
dose-ranging stage of its Phase 2 clinical trial of OMS721 for the
treatment of TMAs with consistent and robust improvement in
efficacy measures. OMS721 was well tolerated by all patients in all
dosing cohorts throughout the treatment periods. Chronic
preclinical toxicity studies have been completed and demonstrated
no safety concerns, allowing chronic dosing in clinical trials.
Additional patients were enrolled in the high-dose cohort and the
fixed-dose stage of the Phase 2 clinical trial is expected to
continue in 2016. The company is preparing to discuss Phase 3 trial
design with FDA later this year or in the early part of 2016. In
addition, investigator-requested compassionate use for OMS721
continues to be available to European patients with aHUS for whom
it has been and will be requested. Based on the positive efficacy
and safety data in TMAs, Omeros is currently expanding clinical
trials to evaluate OMS721 in IgA nephropathy and other
complement-related renal disorders.
- In our Phase 2 clinical trial of OMS721 for the treatment of
TMAs, an additional patient in the high-dose cohort of the
dose-ranging stage has completed dosing. This patient has a history
of lymphoma for which he underwent hematopoietic stem cell
transplant (HSCT). His post-transplant course has been complicated
by a number of life-threatening disorders, including platelet
transfusion-requiring TMA. Despite transfusions, the patient's TMA
persisted and he was enrolled in our OMS721 Phase 2 trial.
Following the four-week dosing period, platelet count quadrupled,
resulting in a count of more than 100,000; haptoglobin level more
than doubled and was normal; plasma lactate dehydrogenase level, a
measure of damage within blood vessels, decreased by 35 percent but
still above normal; and schistocyte (i.e., fragmented red blood
cell) count remained at only one. Throughout dosing with OMS721 and
since completing OMS721 treatment, the patient has not required
platelet transfusions or plasmapheresis.
- Clinical trials evaluating OMS824 in Huntington's were
previously suspended at the request of the FDA. Recently, based on
review of our submission of requested data, the FDA notified us
that we are permitted to resume clinical trials in our Huntington's
program, with dosing limitations. The dosing limitations are
subject to removal pending submission and FDA review of additional
information. We are moving forward with the Huntington's program
and will generate additional data for further discussion with the
FDA. Given that there was no active schizophrenia trial at the time
of program suspension, the FDA will address the OMS824
schizophrenia program when we have a related trial protocol ready
for initiation.
- To ensure that patients, surgeons and facilities can access the
benefits of Omidria, Omeros introduced the OMIDRIAssure™
Reimbursement Services Program in the fourth quarter with
comprehensive reimbursement services including the "Equal Access"
Patient Assistance Program for financially eligible
government-insured and uninsured patients and the "We Pay the
Difference" Commercial Reimbursement Program for patients with
insufficient commercial insurance to cover the cost of
Omidria.
- In October 2015 Omeros entered
into an agreement with Apexus, LLC, an authorized 340B prime
vendor, entitling its customers to purchase Omidria from Omeros'
wholesalers at a greater discount (i.e., sub-340B/sub-WAC) than
those offered under the company's PHSA Pharmaceutical Pricing
Agreement. Omeros has confirmed reimbursement coverage for Omidria
from one-hundred percent (100%) of Medicare Administrative
Contractors and 145 million of the 155 million lives represented by
the top 30 commercial insurance payers as well as from AARP, USAA,
TRICARE and Blue Cross/Blue Shield regional plans.
- As noted in Omeros' second quarter 2015 earnings release, the
European Commission (EC) approved Omidria for use in cataract
surgery and lens replacement procedures to maintain mydriasis
(pupil dilation), prevent miosis (pupil constriction) and to reduce
postoperative eye pain. Decisions about price and reimbursement for
Omidria are made on a country-by-country basis and will be required
before marketing may occur in a particular country. The company
plans to enter into one or more partnerships for the marketing and
distribution of Omidria in the EU, the timing of which depends on
numerous factors, including domestic sales of Omidria.
Financial Results
For the quarter ended September 30,
2015, revenue was $3.3
million, including $3.2
million of Omidria product sales. Omidria units shipped by
the company's wholesalers during the third quarter increased by 71%
from the prior quarter based on data received from wholesalers. Net
revenue per vial sold, including all gross-to-net adjustments,
remained unchanged from the second quarter. Wholesaler buying
patterns in the third quarter are responsible for the significant
difference between reported revenues and wholesaler units shipped
to ASCs and hospitals, with wholesalers at the end of the quarter
holding minimal inventory. The increase in units shipped by the
wholesalers reflects growth in customer base, order frequency and
average order size.
Total costs and expenses, including noncash expenses, for the
three months ended September 30, 2015
were $22.6 million compared to
$17.3 million for the same period in
2014. The increase was primarily due to expenses related to sales
and marketing costs for the U.S. commercial launch of Omidria and
increased research and development activities related to
OMS721.
For the three months ended September 30,
2015, Omeros reported a net loss of $19.9 million, or $0.53 per share, which included noncash expenses
of $2.7 million ($0.07 per share). This compares to a net loss of
$18.3 million, or $0.54 per share, for the same period in 2014,
which included noncash expenses of $2.6
million ($0.08 per share).
At September 30, 2015, Omeros had
cash, cash equivalents and short-term investments of $35.0 million.
Conference Call Details
Omeros' management will host a conference call to discuss the
financial results and to provide an update on business activities.
The event will be held today at 1:30 p.m.
Pacific Time (PT); 4:30 p.m. Eastern
Time (ET). To access the live conference call via phone,
please dial (844) 831-4029 from the
United States and Canada or
(920) 663-6278 internationally. The participant passcode is
2186632. Please dial in approximately 10 minutes prior to the start
of the call. A telephone replay will be available for one week
following the call and may be accessed by dialing (855) 859-2056
from the United States and
Canada or (404) 537-3406
internationally. The replay passcode is 2186632.
To access the live or subsequently archived webcast of the
conference call, go to the Company's website at www.omeros.com and
go to "Events" under the Investors section of the website. Please
connect to the website at least 15 minutes prior to the call to
allow for any software download that may be necessary.
About Omeros Corporation
Omeros is a biopharmaceutical company committed to
discovering, developing and commercializing both 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 (IOL) replacement to
maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain. In
the European Union, European Commission has approved
Omidria for use in cataract surgery and lens replacement procedures
to maintain mydriasis (pupil dilation), prevent miosis (pupil
constriction), and to reduce postoperative eye
pain. Omeros has five clinical-stage development programs
focused on: complement-related thrombotic microangiopathies;
Huntington's disease, schizophrenia, and cognitive impairment;
addictive and compulsive disorders; and preventing problems
associated with urologic surgical procedures. In
addition, Omeros 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, product
commercialization including with respect to Omidria® and
OMS103, Omeros' ability to partner and commercialize Omidria in
Europe, Omeros' 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 the Securities and
Exchange Commission on November 9,
2015. 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
|
|
Nine Months
Ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Product sales,
net
|
|
$
3,244
|
|
$
—
|
|
$
6,607
|
|
$
—
|
Grant
revenue
|
|
15
|
|
214
|
|
227
|
|
359
|
Total
revenue
|
|
3,259
|
|
214
|
|
6,834
|
|
359
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
248
|
|
—
|
|
624
|
|
—
|
Research and
development
|
|
13,264
|
|
11,772
|
|
33,482
|
|
36,196
|
Selling, general and
administrative
|
|
9,048
|
|
5,574
|
|
25,926
|
|
14,196
|
Total costs and
expenses
|
|
22,560
|
|
17,346
|
|
60,032
|
|
50,392
|
Loss from
operations
|
|
(19,301)
|
|
(17,132)
|
|
(53,198)
|
|
(50,033)
|
Interest
expense
|
|
(871)
|
|
(944)
|
|
(2,765)
|
|
(2,555)
|
Investment income and
other income (expense), net
|
|
251
|
|
(251)
|
|
693
|
|
(372)
|
Net
loss
|
|
$
(19,921)
|
|
$
(18,327)
|
|
$
(55,270)
|
|
$
(52,960)
|
Basic and diluted net
loss per share
|
|
$
(0.53)
|
|
$
(0.54)
|
|
$
(1.48)
|
|
$
(1.61)
|
Weighted-average
shares used to compute basic and diluted net loss per
share
|
|
37,923,353
|
|
34,005,642
|
|
37,417,915
|
|
32,945,346
|
OMEROS
CORPORATION
|
CONSOLIDATED
BALANCE SHEET DATA
|
(In
thousands)
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
|
|
|
2015
|
|
2014
|
|
|
|
|
|
|
(unaudited)
|
|
|
Cash, cash
equivalents and short-term investments
|
|
|
|
|
|
$
34,999
|
|
$
6,886
|
Total
assets
|
|
|
|
|
|
41,417
|
|
11,090
|
Total current
liabilities
|
|
|
|
|
|
22,273
|
|
18,431
|
Notes
payable
|
|
|
|
|
|
28,551
|
|
32,709
|
Accumulated
deficit
|
|
|
|
|
|
(383,316)
|
|
(328,046)
|
Total shareholders'
equity (deficit)
|
|
|
|
|
|
(9,004)
|
|
(42,654)
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/omeros-corporation-reports-third-quarter-2015-financial-results-300175159.html
SOURCE Omeros Corporation