Feb. 11, 2014, 7:29 AM
- Regeneron (REGN +2%) net profit -79% to $97M, due to a non-cash tax benefit of $336M in Q4 2012, an income tax provision in 2013, and higher operating costs last year.
- Eylea net U.S. sales $402M vs $276M a year earlier; international $184M vs $19M.
- Cash position: $1.08B at end of 2013 vs $588M.
- Forecasts 2014 Eylea net product sales of $1.7-1.8B in U.S. vs. $1.41B in 2013.
- Expects Eylea to continue growing "through demographic and geographic expansion," as well as via potential approvals in new indications. (PR)
Feb. 11, 2014, 6:31 AM| Comment!
Feb. 11, 2014, 12:05 AM
Feb. 10, 2014, 5:30 PM
Feb. 10, 2014, 8:16 AM
- Regeneron's (REGN +3.15%) Eylea treatment improved vision and maintained that improvement over two years in a Phase III trial of patients with diabetic macular edema (DME).
- DME is a leading cause of blindness in younger and middle-aged adults; Eylea could potentially treat over 6M sufferers globally.
- Regeneron and partner Bayer (BAYRY) are waiting for U.S. and EU approval of Eylea to treat DME; the therapy has already been authorized for other indications, including wet age-related macular edema. (PR)
Jan. 15, 2014, 9:55 AM
- Shares of Regeneron (REGN -4.4%) are pulling back after a big run Tuesday.
- BMO has downgraded the stock to Market Perform from Outperform.
- Price target is unchanged at $331.
- See also: Roth upbeat on REGN amid new Bayer deal, genetics initiative
Jan. 14, 2014, 12:43 PM
- Roth Capital is out with a bullish note on Regeneron (REGN +9.1%) on the heels of the company's announcement of a new development agreement with Bayer.
- Here's analyst Joseph Pantginis, commenting: "Preclinical studies have suggested that blocking both PDGFR-beta and vascular endothelial growth factor (VEGF) can provide additional benefit over anti-VEGF treatment (such as EYLEA) alone in wet AMD."
- Buy rating maintained.
- Price target is $362.
- In other company news, REGN has announced a collaboration with Geisinger Health System under which the companies will "study the genetic determinants of human disease." Additionally, Sanofi (SNY) has amended its investor agreement with REGN and retains the right to "acquire up to 30% of REGN's outstanding common stock and Class A stock [while gaining] the right to nominate a single independent director to the Regeneron Board of Directors upon reaching 20% ownership [stake]."
Jan. 14, 2014, 7:40 AM
- Regeneron Pharmaceuticals (REGN) and Bayer (BAYZF) are deepening their relationship with a plan develop a new therapy for wet age-related macular degeneration.
- Bayer will make an upfront payment of $25.5M to Regeneron and up to $40M in options and milestone payments, and it will pay royalties on any product sales outside the U.S.
- Regeneron will retain 100% of U.S. profits.
- Human clinical studies are planned for early this year. (PR)
Jan. 2, 2014, 1:54 PM
- IQWiG, Germany's cost gatekeeper, struck a blow to Regeneron (REGN -0.5%) and Bayer's (BAYZF -4.1%) Eylea Thursday, saying it could not determine whether the drug is superior to Lucentis (NVS -2.1%) in treating macular edema.
- As Reuters notes, the institute's position "could affect the level of reimbursement by public insurers for Eylea in Germany."
Dec. 18, 2013, 7:46 AM
Dec. 10, 2013, 3:24 PM| 3 Comments
Nov. 28, 2013, 7:08 AM
- Bayer (BAYZF) has filed a request in Japan to use Regeneron's (REGN) Eylea to treat Myopic Choroidal Neovascularization (myopic CNV), a common cause of blindness in the country.
- Eylea is already approved in Japan for macular edema following central retinal vein occlusion.
- Regeron is working with Bayer on non-U.S. sales of Eylea.
Nov. 27, 2013, 10:54 AM
- New guidance from the AHA on how doctors should go about facilitating a reduction in their patients' risk of heart attack and stroke "marks the biggest shift in cardiovascular-disease prevention in 30 years," Johanna Bennett writes.
- In short, the new guidelines could dramatically increase the number of patients eligible for statin therapy.
- This is potentially big news for AstraZeneca (AZN +0.6%) as it's "the only drug maker that still has patent protection on a statin." Crestor is protected until 2016.
- Count Amgen (AMGN -0.3%) and Regeneron (REGN -1.8%) among those who may suffer from the new regime. The FDA has indicated that the companies can gain approval for their PCSK-9 inhibitors without proving they prevent heart attacks and although this means faster approval, it could also limit their uptake among physicians, according to some commentators.
- Also affected by the news: Merck (MRK +0.2%) (think Zetia, Vytorin).
Nov. 22, 2013, 7:07 AM
- Sanofi's (SNY) and Regeneron's (REGN) Sarilumab injectable antibody for treating rheumatoid arthritis performed well in a Phase III trial of 1,200 patients when combined with the standard oral treatment methotrexate.
- The combo eased symptoms, including pain, improved physical function, and slowed the progression of the disease.
- The study is one of two Phase III trials planned for Sarilumab.
- Analysts estimate that the drug could generate revenue of €579M ($780M) by 2020. It would compete with Roche's (RHHBY) Actemra and potentially with treatments being developed by AbbVie (ABBV), Johnson & Johnson (JNJ) and Bristol-Myers Squibb Co. (BMY). (PR)
- Meanwhile, Regeneron's Eylea has received approval in Japan for the treatment of macular edema following central retinal vein occlusion, a common vascular disease among the elderly caused by a blockage of one of the small veins that carry blood away from the retina. Regeneron is working with Bayer (BAYZF) on non-U.S. sales of Eylea. (PR)
Nov. 14, 2013, 4:02 PM
- The FDA will not require outcomes studies for approval of PCSK9 cholesterol-lowering drugs, the agency has told Bloomberg.
- The news is good to send Regeneron Pharmaceuticals (REGN +4.2%) shares upward into the close. The agency's stance will also help the cholesterol-lowering candidates of Amgen, Pfizer, and Sanofi-Aventis.
- On the other side of the fence, Aegerion Pharmaceuticals (AEGR -4.2%) shares ticked down into the close, given the company's already-approved cholesterol drug.
Nov. 7, 2013, 3:16 PM
- Bayer (BAYZF) files for EU marketing approval of Eylea in DME.
- Eylea was an important driver for both Bayer and Regeneron (REGN -4.8%) in Q3 (see here and here).
- REGN has a BLA pending for DME in the U.S., where Piper's Edward Tenthoff sees indication-specific sales of $54M in H2 2014, $177M in 2015, and $993M by 2020 (so blockbuster status just for DME eventually).
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