Omeros Corporation Reports Third Quarter 2018 Financial Results
– Conference Call
3Q 2018 total and OMIDRIA® revenues were
$4.6 million, compared to $1.7 millionin 2Q 2018 and $21.7 millionin last year’s third quarter. The increase over the last quarter is primarily due to revenues from the company’s wholesalers in anticipation of renewed buying from ambulatory surgery centers (ASCs) and hospitals as a result of the reinstatement of pass-through reimbursement on October 1, 2018. The decrease from 3Q 2017 is due to the significant reduction in OMIDRIA usage by ASCs and hospitals in 3Q 2018 as a result of the absence of transitional pass-through reimbursement, which expired for OMIDRIA on January 1, 2018.
October 2018was 81% of sell-through in October 2017, which was our highest month of OMIDRIA sell-through to date.
The recently released 2019 Outpatient Prospective Payment System
(OPPS) final rule for the
Centers for Medicare & Medicaid Services(CMS) includes provisions that are expected to provide for continued separate reimbursement for OMIDRIA after its recently reinstated pass-through status expires on October 1, 2020.
Net loss in 3Q 2018 was
$39.5 million, or $0.81per share. Non-cash expenses were $5.0 million, or $0.10per share.
September 30, 2018, the company had cash, cash equivalents and short-term investments available for operations of $55.2 million.
- Results from the second reported cohort from Omeros’ ongoing Phase 2 clinical trial in patients with Immunoglobulin A (IgA) nephropathy are consistent with the first cohort and demonstrated significant reductions in proteinuria ranging from greater than 50% to approximately 70% following extended treatment with OMS721.
Recent meetings with multiple European national regulatory authorities
resulted in uniform recommendations to submit a marketing
authorization application, or MAA, for full approval of OMS721 for
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA). Based on these meetings,
Omeroshas filed with the European Medicines Agency(EMA) a letter of intent to submit a marketing authorization application (MAA) via EMA’s centralized procedure for approval of OMS721 for the treatment of HSCT-TMA and expects to receive assignment of a rapporteur and co-rapporteur by year end.
The U.S. Food and Drug Administration( FDA) granted orphan drug designation to OMS721 for the treatment of HSCT-TMA, and the European Commissionadopted a decision designating OMS721 as an Orphan Medicinal Product in the European Unionfor treatment in HSCT.
- Omeros’ Phase 1 clinical trial for the company’s lead phosphodiesterase 7 (PDE7) inhibitor OMS527 is underway, and the company has completed dosing in the first six cohorts of subjects, which included a food effect study. The compound has been well tolerated, and pharmacokinetic data support once-daily dosing, with or without food.
“We are pleased with the strong demand that we are seeing for OMIDRIA so
soon following reinstatement of its pass-through payment status,” said
Third Quarter and Recent Developments
Developments regarding OMIDRIA (phenylephrine and ketorolac
intraocular solution) 1% / 0.3% include:
Pass-through status for OMIDRIA was reinitiated on
October 1, 2018following a three-quarter hiatus. Sell-through for October 2018has already reached 81% of sell-through achieved in October 2017, which was our highest month of OMIDRIA sell-through to date.
CMS recently released its 2019 final rule for the OPPS. In it, CMS
indicated that it will separately pay in the ASC setting for
non-opioid drugs used during surgery that have an
FDA-approved indication for postoperative pain relief and that are packaged in calendar year 2019. Although OMIDRIA is not specifically named because it is paid separately until October 1, 2020, Omerosbelieves that OMIDRIA meets the definition for this non-opioid exclusion. The preamble to this section of the OPPS Final Rule indicates that CMS will apply the exclusion from packaged payment to other drugs in the future if they meet the criteria. The OPPS Final Rule also states that CMS will consider in future rulemaking a policy that pays separately for drugs used during cataract surgery that have an FDA-approved indication to address postoperative issues. Omerosbelieves that OMIDRIA also meets this definition.
- The most recent manuscripts published or submitted for publication reporting the results of “real-world” clinical studies show that, compared to epinephrine in both conventional and femtosecond-laser assisted cataract surgery, OMIDRIA decreased the need for pupil expansion devices and shortened surgical times for cataract surgery, demonstrating how the use of OMIDRIA may increase the efficiency and reduce the costs of cataract surgery. These studies add to the growing body of published real-world clinical studies demonstrating significant benefits of OMIDRIA to both patients and surgeons across routine and complex cataract surgery cases.
- Pass-through status for OMIDRIA was reinitiated on
Developments regarding OMS721, Omeros’ lead human monoclonal antibody
in its mannan-binding lectin-associated serine protease-2 (MASP-2)
programs for the treatment of HSCT-TMA, IgA nephropathy, and atypical
hemolytic uremic syndrome (aHUS), include:
The company met recently with multiple European national
regulatory authorities focused on approval pathways for OMS721 for
the treatment of HSCT-TMA. Feedback from the European national
regulatory authorities has been uniformly positive, each
Omerossubmit an MAA for full approval of OMS721 in HSCT-TMA.
The company has filed with the
European Medicines Agencya letter of intent to submit an MAA for OMS721 in HSCT-TMA via the centralized procedure and looks forward to receiving assignment of a rapporteur and co-rapporteur who will work with the company through the MAA submission and review process. Close interactions with the FDAand European regulatory agencies are ongoing and the company continues preparations for U.S. Biologics License Application (BLA) and European MAA submissions.
The company is preparing to begin collection of chart-review-based
historical data following finalization of the data collection and
analysis plan. The comparison of OMS721-treated patients to the
historical control is designed to support accelerated approval in
the U.S. and full approval in
October 2018, Omerosreported positive results in patients with IgA nephropathy from the second reported cohort of the ongoing Phase 2 clinical trial. The cohort was designed to provide descriptive data on the effects of single and multiple 12-week courses of treatment with OMS721 in a small number of patients. Unlike the first cohort, patients in the second cohort were not taking steroids. Twelve patients were enrolled and data were reported for the nine evaluable patients. At the time of reporting, all patients had completed at least one 12-week course of treatment with either OMS721 or placebo and were eligible for OMS721 treatment during the dosing-extension phase of the study.
- At week 18, median reduction in proteinuria was 18.4 percent in the five OMS721-treated patients and 18.0 percent in the four placebo patients.
- Eight patients had at least 18 weeks of data and received at least one 12-week course of treatment with OMS721. In these patients, median reduction from baseline proteinuria was 56 percent; and five of the eight had received only one course of OMS721 treatment.
- Four patients in this OMS721 dosing-extension period have reached between nine and 12 months beyond baseline, and show reductions in proteinuria of 54 percent, 57 percent, 65 percent, and 68 percent. At most recent assessment, two of these four patients continued to demonstrate sustained reductions in proteinuria for 2.5 and 5 months, respectively, after cessation of treatment with OMS721; the other two patients just recently completed treatment courses.
- The company and international experts in IgA nephropathy believe that these data are strongly positive and supportive of a disease modifying effect, with the magnitude of proteinuria reduction consistent with that from the previously reported first cohort of the clinical trial.
Omerosannounced in October 2018that the FDAgranted orphan drug designation to OMS721 for the treatment of HSCT-TMA and announced in July 2018that the European Commissionadopted a decision designating OMS721 as an Orphan Medicinal Product in the European Unionfor treatment in HSCT.
- The company met recently with multiple European national regulatory authorities focused on approval pathways for OMS721 for the treatment of HSCT-TMA. Feedback from the European national regulatory authorities has been uniformly positive, each recommending that
In Omeros’ phosphodiesterase 7, or PDE7, program, the company is
developing proprietary compounds to treat addiction and compulsive
disorders as well as movement disorders. A Phase 1 single-ascending-
and multiple-ascending-dose clinical trial is underway with the
company’s lead PDE7 inhibitor and is designed to assess safety and
pharmacokinetics of the compound in healthy subjects. The company has
completed dosing in the first six cohorts of subjects, including one
cohort that assessed food effect. The compound to date has been well
tolerated and pharmacokinetic data support once-daily dosing, with or
without food. Completion of the Phase 1 trial is slated for the first
half of 2019. Following Phase 1 completion, if successful,
Omerosplans to conduct an initial OMS527 Phase 2 clinical trial in patients with nicotine addiction.
For the quarter ended
During the last week of September and for
Total costs and expenses for the three months ended
For the three months ended
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 at
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.
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,” “plan,” “potential,” “predict,” “project,” “prospects,”
“should,” “slated,” “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, the ability for OMIDRIA to obtain separate reimbursement as
part of CMS’ OPPS, 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
|UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share data)|
|Three Months Ended||
Nine Months Ended
|Product sales, net||$||4,608||$||21,658||$||7,852||$||51,067|
|Costs and expenses:|
|Cost of product sales||36||184||355||613|
|Research and development||26,862||14,835||64,414||40,212|
|Selling, general and administrative||13,152||11,749||36,830||40,016|
|Total costs and expenses||40,050||26,768||101,599||80,841|
|Loss from operations||(35,442||)||(5,110||)||(93,747||)||(29,774||)|
|Basic and diluted net loss per share||$||(0.81||)||$||(0.16||)||$||(2.13||)||$||(0.83||)|
|Weighted-average shares used to compute basic and diluted net loss per share||48,647,416||46,262,211||48,437,870||44,709,418|
|UNAUDITED CONSOLIDATED BALANCE SHEET DATA|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||55,156||$||83,749|
|Total current liabilities||24,587||26,307|
|Notes payable and lease financing obligations, net||132,255||84,607|
|Total shareholders’ deficit||(88,997||)||(2,814||)|
Cook Williams Communications, Inc.
Jennifer Cook Williams, 360-668-3701
Investor and Media Relations