Brian Feroldi: Omeros is an underdog stock that I've followed for some time with great interest: It stands a real chance of wreaking havoc on the business model of Alexion Pharmaceuticals, a biotech giant that I'm quite fond of.
Right now Alexion Pharmaceuticals' best selling drug is Soliris, which is approved to treat two ultrarare diseases: paroxysmal nocturnal hemoglobinuria, or PNH, and atypical hemolytic uremic syndrome, or aHUS. Soliris is currently the only drug on the market that treats either of these diseases, and since they are both orphan indications, Alexion yields enormouspricing power. Soliris' list price tops $537,000 per year in the U.S., and worldwide sales of the drug are expected to top $2.8 billion in 2016.
A market that massive is bound to create competition, which is where Omeros comes into the picture. Omeros' most exciting product candidate is OMS721, which the company is studying as a potential treatment for aHUS. The drug has already performed well in early clinical trials, and right now it is starting Phase 3. While it's hard to handicap its chances of regulatory success, OMS721 already has both orphan-drug designation and fast-track status. To me, that hints that it has a better-than-average chance of finding its way to market.
That fact should concern Alexion Pharmaceuticals investors, since Omeros could start a price war if OMS721 does win approval. If that happens, it would greatly hinder Alexion's growth prospects, which would certainly do bad things to its lofty stock price.
It's worth pointing out that Alexion is aware of the potential threat, and it's studying Soliris for uses beyond PHN and aHUS. If those go well, they could help to soften the blow if OMS721 does eventually find its way to market.
Still, Omeros stands a chance of being a real thorn in Alexion's side if things go according to plan, which is why it is one underdog stock that I plan on watching like a hawk.
From the news release .....
1Q 2016 revenues were $7.4 million, an 11% increase over 4Q 2015.
OMIDRIA units shipped by wholesalers (“sell-through”) increased 20% over 4Q 2015.
OMIDRIA sales accelerated substantially in the second half of 1Q, with March accounting for nearly 50% of quarterly sales.
OMIDRIA sales growth trajectory has continued into 2Q with sales to date approximately 65% higher than the corresponding period in 1Q.
Based on recent sales activity, net sales of OMIDRIA, without any additional growth, annualize to an approximate run rate of $45 million to $50 million.
“OMIDRIA sales continued to grow substantially in Q1,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros(OMER). “Growth in the first part of the quarter was relatively restrained due to both internal and external factors, with sales markedly ramping in March. The acceleration in sales growth has continued into the second quarter, with the run rate for OMIDRIA net sales in recent weeks annualizing to approximately $45 million to $50 million. We continue to expect that we will reach cash-flow positive status later this year, fully funding our pipeline. That pipeline continues to advance, with OMS721 entering a Phase 3 program for aHUS and two OMS721 Phase 2 trials ongoing in TMAs and renal disease. The remainder of the pipeline is progressing nicely, and 2016 is shaping up to hold a number of value-driving milestones.”
Q1 results will be out Tuesday morning ......
May 4, 2016-- Omeros Corporation ..... , today announced that the company will issue its first quarter 2016 financial results for the period ended March 31, 2016, on Tuesday, May 10, 2016, before the market opens. Omeros management will host a conference call and webcast that day at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) to discuss the financial results.
Omeros Corporation Announces Independent Studies with OMIDRIA® to Be Presented at Upcoming Ophthalmology Congresses
26-Apr-2016 7:00 AM
-- Studies Assessed Key Surgical Outcome Measures Including Complication Rates --
SEATTLE--(BUSINESS WIRE)--Apr. 26, 2016-- 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 that new research related to the clinical utility of OMIDRIA (phenylephrine and ketorolac injection) 1% / 0.3% and the importance of preempting intraoperative miosis and inflammation during cataract surgery will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting in Seattle, Washington, May 1 - 5, 2016, and the American Society of Cataract and Refractive Surgery (ASCRS) Congress in New Orleans, Louisiana, May 6 - 10, 2016. Presentations will address the beneficial effects demonstrated in case-controlled studies of OMIDRIA on complication rates, on use of pupil-expanding devices, on surgical times and on postoperative visual acuity.
"As utilization of OMIDRIA in cataract surgery continues to grow, we are accumulating a wealth of data across varied ophthalmic conditions, clinical settings and practice patterns," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "These findings underscore the important benefits of OMIDRIA to both patients and surgeons - improving outcomes, streamlining procedures and reducing risks."
(News release lists all of the studies)
Patient Dosing Initiated for OMS721 Phase 2 Program in Renal Diseases
Date(s): 20-Apr-2016 7:00 AM
-- Study Provides an Opportunity for Breakthrough Therapy Designation and Subsequent Accelerated Approval --
SEATTLE--(BUSINESS WIRE)--Apr. 20, 2016-- Omeros Corporation (NASDAQ: OMER) today announced initiation of patient dosing in its OMS721 Phase 2 program in corticosteroid-dependent renal diseases. The Phase 2 clinical trial of OMS721, the company's lead mannan-binding lectin-associated serine protease-2 (MASP-2) inhibitor being developed for complement-related diseases, is evaluating the effects of OMS721 on kidney function in patients with corticosteroid-dependent renal diseases. This new trial expands the company's MASP platform, which includes an OMS721 Phase 3 program in progress for the treatment of atypical hemolytic uremic syndrome (aHUS) as well as an ongoing Phase 2 program of OMS721 for the treatment of other thrombotic microangiopathies (TMAs).
This new Phase 2 clinical trial includes patients with corticosteroid-dependent IgA nephropathy, membranous nephropathy, C3 glomerulopathy and lupus nephritis. Evidence implicates the complement system, and specifically the lectin pathway, in the pathogenesis of each of these serious diseases. Despite ongoing treatment with corticosteroids, these patients have evidence of progressive kidney disease and are at high risk for kidney failure and dialysis. Continued corticosteroid use carries significant patient risks and is associated with serious side effects. There are no FDA-approved treatments for corticosteroid-dependent patients who have persistent renal inflammation. Treatments for these diseases that improve kidney function, slow disease progression or avoid long-term corticosteroid use would meet a significant unmet medical need.
(Much more in the news release.)
FWIW, I had been assuming that the Omidria program within OMER was projected to become cash flow positive later this year. However, at the end of the brief Q&A today, Demopulos stated explicitly that the Omidria program is already cash flow positive and that they expect Omidria to make OMER, the full company, cash flow positive later this year.
SEATTLE--(BUSINESS WIRE)--Apr. 7, 2016-- 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 that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 15th Annual Needham Healthcare Conference in New York next week. The presentation is scheduled for Wednesday, April 13, 2016, at 2:20 p.m. EDT.
The presentation will be webcast. The live and archived webcasts can be accessed on the "Events" page of the company's website.