– Conference Call Today at 4:30 p.m. ET
–
Omeros Corporation (NASDAQ: OMER), 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, today
announced recent highlights and developments as well as financial
results for the first quarter ended March 31, 2019, which
include:
- 1Q 2019 total and OMIDRIA® revenues
were $21.8 million compared to $1.6 million and $22.0 million in
the first and fourth quarters of 2018, respectively. 1Q 2019
revenues reflect the seasonally lower volume of cataract surgery
performed in the first quarter and the timing of normal wholesaler
purchases shifting from the end of March to the first week of
April.
- “Sell-through” – the number of
units sold by wholesalers to ASCs and to hospitals – for 1Q
2019 was a record high, increasing 14 percent from the previous
high-water mark set in 4Q 2018. Sell-through in the current quarter
has continued to grow at a double-digit rate over the same period
in the first quarter.
- Net loss in 1Q 2019 was $24.3 million,
or $0.50 per share, which includes non-cash expenses of $6.0
million, or $0.12 per share. Overall decrease in cash, cash
equivalents and short-term investments for the quarter was $13.3
million.
- At March 31, 2019, the company had
cash, cash equivalents and short-term investments available for
operations of $47.2 million.
- Since the previously reported FDA
meeting held in the first quarter of 2019, which resulted in a
streamlined path to submission of a Biologics License Application
(BLA) for narsoplimab in HSCT-TMA, the company has had two
additional meetings with FDA. The first covered chemistry,
manufacturing and controls (CMC), and the company’s CMC
commercialization plan remains on track. In the second, a clinical
meeting, Omeros reached agreement with FDA on the large majority of
the criteria for the primary endpoint. The company expects to
complete agreement on the few remaining details in the very near
future and is confident that the efficacy and safety data for
narsoplimab will support BLA approval in HSCT-TMA.
- CMS recently issued a preliminary
decision to establish a unique permanent HCPCS J-code for OMIDRIA.
The decision is expected to be finalized no later than November
with the J-code becoming effective on the first day of the
following quarter. A J-code provides a uniform, simpler and widely
accepted process for providers to bill for OMIDRIA across both
Medicare and commercial insurance plans.
“We are pleased with the company’s performance to date in 2019,
having made substantial strides on all fronts,” said Gregory A.
Demopulos, M.D., Omeros’ chairman and chief executive officer.
"Once again we saw OMIDRIA posting record quarterly sell-through
numbers, up 14 percent over the record set in 4Q 2018, and the
product’s growth trajectory has continued this quarter. Narsoplimab
is advancing across three Phase 3 programs and, based on recent
interactions with FDA, we expect very soon to wrap up the remaining
criteria for the primary endpoint in stem cell TMA, are confident
that our data will support a BLA approval and are moving forward
with preparations for a commercial launch. Our PDE7 inhibitor,
OMS527, is also faring well in its Phase 1 clinical trial, which is
slated to finish later this quarter or next. Further expanding our
complement franchise, both OMS906, our antibody against MASP-3, and
our small-molecule MASP-2 inhibitor are planned to enter the clinic
next year. We are also continuing to drive the development of our
small-molecule compounds targeting GPR174, a receptor that
increasingly appears to control a major cancer pathway. Across all
of these efforts, our primary focus remains the patient. In over
600,000 procedures, cataract surgery patients have experienced the
benefits of OMIDRIA, and we look forward to making narsoplimab
commercially available worldwide in the near future.”
First Quarter and Recent Developments
- Recent developments regarding OMIDRIA
include the following:
- The Centers for Medicare & Medicaid
Services (CMS) issued a preliminary decision to establish a unique
permanent Healthcare Common Procedure Coding System (HCPCS) J-code
for OMIDRIA. The preliminary decision is included in the publicly
available agenda for the agency’s upcoming HCPCS Workgroup meeting
on May 15, 2019. The decision is expected to be finalized no later
than November 2019, with the code becoming effective on the first
day of the following quarter. If finalized, assignment of a J-code
for OMIDRIA would provide a uniform and widely accepted process
that is expected to simplify billing for the drug across Medicare
as well as commercial insurance plans.
- In May 2019, the results of a
“real-world” clinical study were presented at the annual meeting of
the American Society of Cataract and Refractive Surgery and
American Society of Ophthalmic Administrators held in San Diego.
The study compared the incidence of cystoid macular edema (CME), a
sight-threatening complication of cataract surgery, in patients
undergoing cataract surgery using OMIDRIA with postoperative NSAIDs
alone versus those using postoperative corticosteroids, with and
without NSAIDs, in the absence of OMIDRIA. The retrospective
analysis of cataract surgery performed on 504 eyes (357 patients)
showed that use of OMIDRIA reduced the incidence of CME by 3- to
12-fold compared to published data on cataract procedures performed
without OMIDRIA. This study, together with the 17 peer-reviewed
articles already published on the benefits of OMIDRIA, supports
Omeros’ ongoing efforts to secure permanent separate payment for
the drug.
- Recent developments regarding
narsoplimab, 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:
- Omeros has had two additional meetings
with the U.S. Food and Drug Administration (FDA) – one to cover
chemistry, manufacturing and controls-related topics in preparation
for commercialization and, most recently, to finalize the criteria
for the HSCT-TMA trial’s primary endpoint on which the clinical
data will be assessed. The company’s CMC commercialization plan
remains on track. In the clinical meeting, Omeros reached agreement
with FDA on the large majority of the criteria for the primary
endpoint, which will include both laboratory and organ function
components. The meeting included a detailed discussion of the
primary endpoint and the company believes that it has a good
understanding – and is comfortable with – FDA’s position on the
final few remaining details. Omeros expects to complete agreement
on these last few details in the very near future. In light of
discussions with FDA and the available data on narsoplimab
treatment of HSCT-TMA patients, the company is confident that its
efficacy and safety data will support approval.
- In March 2019, Omeros launched a
disease education initiative at the annual meeting of the European
Society for Blood and Marrow Transplantation (EBMT) with a
well-attended educational session sponsored by Omeros and entitled
“How do I…diagnose HSCT-TMA.” A focus of the session was the
relationship between HSCT-TMA and the broader syndrome of disorders
caused by endothelial injury, which is important across the
company’s development of MASP-2 inhibitors, including
narsoplimab.
- Omeros also announced the presentation
at EBMT of a case report of resolution of gastrointestinal HSCT-TMA
following narsoplimab treatment. The case was presented
by Rafael Duarte M.D., Ph.D., F.R.C.P., Associate Professor,
Head of Hematopoietic Transplantation and Hemato-oncology Section,
University Hospital Puerta de Hierro Majadahonda, Madrid and
Secretary of the EBMT. Dr. Duarte described an 18-year-old
patient with biopsy-proven HSCT-TMA of the gastrointestinal tract
causing severe gastrointestinal bleeding requiring transfusions.
Upon receiving narsoplimab, her TMA resolved and all transfusions
were discontinued. The patient continues to do well after cessation
of narsoplimab treatment.
- Omeros’ Phase 3 trial evaluating
narsoplimab for IgA nephropathy, referred to as ARTEMIS-IGAN,
continues to enroll. Results from the Phase 2 study of narsoplimab
in IgA nephropathy are expected to be presented at the annual
Congress of the European Renal Association - European Dialysis and
Transplant Association in Budapest in June. In addition, together
with its Academic Leadership Committee of international experts on
IgA nephropathy, the company is preparing a series of manuscripts
directed to narsoplimab and its IgA nephropathy program with the
first manuscript planned for submission soon.
- Updates regarding Omeros’ other
development programs and platforms include the following:
- The development of small-molecule
MASP-2 inhibitors continues, and lead compounds are being optimized
for potency, oral bioavailability and target selectivity. Omeros
expects to enter the clinic with an orally administered MASP-2
inhibitor next year.
- The company’s MASP-3 inhibitor, OMS906,
is expected to enter clinical trials in the first half of
2020.
- In the company’s Phase 1 trial for
OMS527, which targets treatment of addiction and compulsive
disorders, the company has completed dosing all six cohorts in the
single-ascending-dose portion of the trial, and three
multiple-ascending-dose cohorts. The trial is expected to be
completed during the second or third quarter of this year. The drug
has been well tolerated and pharmacokinetic data are consistent
with once-daily dosing with or without food. A Phase 2a study
targeting nicotine addiction is planned assuming successful
completion of Phase 1.
- In Omeros’ proprietary G protein
coupled receptor (GPCR) platform, development efforts are focused
on several targets, including GPR174. Based on its data, the
company believes that GPR174 controls a major pathway in cancer,
and modulation of the receptor could provide a seminal advance in
immuno-oncologic treatments for a wide range of solid and liquid
tumors. Development continues on small molecule compounds targeting
GPR174 with the objective of entering the clinic as soon as
possible.
- In May 2019, Omeros launched a new
corporate website at www.omeros.com.
- Omeros has approval for and is
finalizing an accounts receivable-based line of credit that, if the
company chooses to implement it, would provide for borrowing
availability of up to $50 million depending on the company’s
available borrowing base.
Financial Results
For the quarter ended March 31, 2018, revenues were $21.8
million, all relating to sales of OMIDRIA. This compares to OMIDRIA
revenues of $1.6 million and of $22.0 million in the first and
fourth quarters of 2018, respectively. 1Q 2019 revenues reflect the
seasonally lower volume of cataract surgery performed in the first
quarter and the timing of normal wholesaler purchases shifting from
the end of March to the first two days of April, when net sales to
wholesalers were approximately $2.4 million. Inventory units on
hand at wholesalers at December 31, 2018 and March 31, 2019 were
effectively the same. Gross-to-net deductions decreased from 28.3
percent in 4Q 2018 to 27.0 percent in 1Q 2019.
Sell-through for 1Q 2019 was a record high, increasing 14
percent from the previous high-water mark set in the 4Q 2018.
Sell-through in the current quarter has continued to grow at a
double-digit rate over the same period in the first quarter.
Total costs and expenses for the three months ended March 31,
2019 were $41.0 million compared to $29.3 million for the same
period in 2018. The increase in the current year quarter was due
primarily to higher third-party manufacturing scale-up costs for
our narsoplimab program as we continue to increase our production
capacity to meet anticipated clinical and commercial requirements,
as well as increased expenses associated with pre-commercialization
activities for narsoplimab and sales and marketing costs related to
the re-introduction of OMIDRIA.
For the three months ended March 31, 2019, Omeros reported a net
loss of $24.3 million, or $0.50 per share, which included non-cash
expenses of $6.0 million, or $0.12 per share. This compares to the
prior year’s first quarter for which Omeros reported a net loss of
$30.1 million, or $0.62 per share, which included non-cash expenses
of $4.3 million, or $0.09 per share.
Overall decrease in cash, cash equivalents and short-term
investments for 1Q 2019 was $13.3 million. As of March 31, 2018,
the company had $47.2 million of cash, cash equivalents and
short-term investments available for operations.
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 1:30 p.m. Pacific Time; 4:30 p.m.
Eastern Time. 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 4095776.
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 4095776.
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.
About Omeros Corporation
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 European Union,
the European Commission has approved OMIDRIA for use in
cataract surgery and other IOL replacement procedures to maintain
mydriasis (pupil dilation), prevent miosis, and to reduce
postoperative eye pain.
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.
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,” “likely,” “look forward to,” “may,” “objective,”
“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 Securities and
Exchange Commission on March 1, 2019, as supplemented from time to
time by the company’s Quarterly Reports on Form 10-Q. 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 UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS (In thousands, except share and per
share data) Three Months Ended March 31,
2019 2018 Revenue: Product sales, net $ 21,779
$ 1,588 Costs and expenses: Cost of product sales 131 203 Research
and development 26,255 18,140 Selling, general and administrative
14,632 10,934 Total costs and expenses 41,018
29,277 Loss from operations (19,239 ) (27,689 ) Interest
expense (5,600 ) (2,825 ) Other income 494 460 Net
loss $ (24,345 ) $ (30,054 ) Comprehensive loss $ (24,345 ) $
(30,054 ) Basic and diluted net loss per share $ (0.50 ) $ (0.62 )
Weighted-average shares used to compute basic and diluted
net loss per share
49,014,009 48,284,019
OMEROS
CORPORATION UNAUDITED CONSOLIDATED BALANCE SHEET DATA
(In thousands) March 31, December 31,
2019 2018 Cash, cash equivalents and short-term
investments $ 47,222 $ 60,498 Working capital 33,780 52,511
Restricted investments 1,154 1,154 Total assets 101,246 95,936
Total current liabilities 44,505 37,356 Lease liabilities 29,139
2,467 Convertible Senior Notes 151,182 148,981 Accumulated deficit
(674,470 ) (650,125 ) Total shareholders’ deficit (121,019 )
(100,156 )
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version on businesswire.com: https://www.businesswire.com/news/home/20190509005894/en/
Jennifer Cook WilliamsCook Williams Communications, Inc.Investor
and Media Relations360.668.3701jennifer@cwcomm.org
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