– Conference Call Today at 4:30 p.m. ET –
SEATTLE–(BUSINESS WIRE)–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.
-
The Centers for Medicare & Medicaid Services (CMS) issued a
-
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.
-
Omeros has had two additional meetings with the U.S. Food and Drug
-
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.
-
The development of small-molecule MASP-2 inhibitors continues, and
- 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 | ) | ||||
Contacts
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org