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Regeneron Pharmaceuticals, Inc. (REGN)

  • Dec. 18, 2013, 7:46 AM
    • The FDA accepts Regeneron Pharmaceuticals' (REGN) sBLA for Eylea in DME.
    • PDUFA date: 08/18/2014
    • Submission based on VIVID and VISTA. (PR)
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  • Dec. 10, 2013, 3:24 PM
    • Barclays is out with its top equity picks for 2014.
    • The firm's top healthcare name is Overweight-rated Regeneron (REGN -0.4%), which Barclays says should "continue to gain share from both Avastin and Lucentis in the AMD space." Price target is $339.
    • Other picks: AET, HCA, GILD, COV, ACT
  • 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.
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  • 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)
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  • 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.
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  • 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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  • Nov. 6, 2013, 2:21 PM
    • Goldman's Terence Flynn tweaks his Regeneron (REGN -3.6%) numbers a bit following Q3 results.
    • Flynn's new estimates: FY14 Eylea sales of $1.88B. That's down from $1.98B previously "to reflect single digit growth in H1 2014 (based on current trends) followed by an acceleration in H2 2014, which assumes Eylea receives priority review for DME."
    • New EPS targets for FY14/15/16: $9.89/$14.35/$16.19.
    • Buy rating maintained.
    • Price target cut to $353 from $355.
  • Nov. 5, 2013, 1:31 PM
    • No surprise here. Deutsche's Robyn Karnauskas keeps Regeneron (REGN +6.7%) at Buy following strong Q3 results anchored by Eylea sales.
    • "Q3 Eylea sales were ahead of expectations at $363M vs. $350M consensus [and] REGN raised full year Eylea U.S. guidance to $1.35-$1.375B vs. $1.3-$1.35B previous," Karnauskas notes.
    • Karnauskas also revises branch retinal vein occlusion success probability to 100% based on Phase 3 study results released late last month.
    • Price target raised to $375 from $310.
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  • Nov. 5, 2013, 8:15 AM
    • Regeneron (REGN) is 5.8% higher in premarket trading after the company easily tops estimates for Q3.
    • Revenue rises 39% Y/Y.
    • Eylea U.S. net product sales come in at $363M, that's up 49% Y/Y. Ex-U.S., Eylea sales print at $125M, up 23%.
    • Zaltrap worldwide net sales: $18M.
    • Collaboration revenues rise 29% to $223M.
    • R&D $224M versus $158M in Q3 2012. SG&A of $98M, up from $47M last year.
    • An sNDA has been submitted for DME (that's one year ahead of the original schedule). (PR)
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  • Nov. 5, 2013, 6:31 AM
    • Regeneron Pharmaceuticals (REGN): Q3 EPS of $2.40 beats by $0.54.
    • Revenue of $597M beats by $95.07M. (PR)
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  • Oct. 21, 2013, 7:22 AM
    • Regeneron's (REGN) Eyelea injection performed well in a Phase III study of patients with Macular Edema following branch retinal vein occlusion, a common vascular disease among the elderly that is caused by a blockage of one of the small veins that carry blood away from the retina.
    • In the trial, 53% of patients who received Eyelea 2 milligram (mg) every four weeks gained at least 15 letters in vision, well above the 27% of patients who received laser treatment. The mean improvement for Eyelea was 17 letters vs 6.9 for laser. (PR)
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  • Oct. 16, 2013, 4:05 PM
    • Brean is pleased with results from Regeneron's (REGN) ODYSSEY MONO trial.
    • "There are 11 other Phase 3 trials coming for alirocumab," analyst Jonathan Aschoff notes, adding that "based on today's results and the three positive Phase 2 trials, [investors should] expect similarly positive results starting in 2014."
    • Aschoff calls the stock a "core biotech holding."
    • Buy rating reiterated.
    • Price target is $367, representing a 19% upside from today's close.
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  • Oct. 16, 2013, 3:15 AM
    • A drug developed by Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) cut levels of the "bad" LDL cholesterol by 47% in a Phase III trial of 103 patients. No major side effects were experienced.
    • The treatment, called Alirocumab, is part of a new class of injectable cholesterol medicines that block a protein called PCSK9. Amgen (AMGN) and Pfizer (PFE) are among those developing such drugs, which could each generate sales of $3B or more.
    • Regeneron and Sanofi hope to file for authorization of Alirocumab by late 2015 after the results of another 11 studies are released. (PR)
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  • Sep. 30, 2013, 1:40 PM
    • Regeneron (REGN +2.7%) enjoys some bullish commentary out of the sell-side following the presentation of Phase 3 Eylea data in DME at the Retina Society's annual meeting. (full presentation)
    • "The data clearly supports label expansion with blockbuster potential even competing with approved Lucentis (RHHBY.OB, NVS) and off-label Avastin," Piper's Edward Tenthoff says, before going on record with predictions of $56M and $177M in sales in H2 2014 and FY15 for the new indication, respectively. Price target raised to $360 from $336.
    • Goldman is out with similar comments, saying the VIVID/VISTA data "were in line with ... expectations and [should] support approval for a broader label and drive uptake/growth.” Price target raised to $355 from $329.
    • Also: Oppenheimer's David Ferreiro lifts his target to $310 from $300.
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  • Sep. 18, 2013, 11:46 AM
    • Regeneron Pharmaceuticals (REGN +3.7%) has been on a nice run of late thanks in part to speculation (fueled by some rather specific comments Chris Viehbacher made last week) that Sanofi (SNY -0.3%) may up its 16% stake to as much as 30% (the maximum allowed under the companies' partnership).
    • REGN is extending its gains today and is set to present Phase 3 VIVID/VISTA Eylea data later this month at the Retina Society's annual meeting. (PR)
    • There's also chatter that Goldman's Terence Flynn has upped his price target on the shares to $329 from $298.
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Company Description
Regeneron Pharmaceuticals Inc is a fully integrated biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.
Sector: Healthcare
Industry: Biotechnology
Country: United States