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Regeneron Pharmaceuticals, Inc. (REGN)

  • 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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  • Sep. 16, 2013, 5:10 PM
    • Novartis (NVS) closed the day down by more than 1% after Barclays cut the shares to Underweight (price target $69).
    • Analyst Mark Purcell thinks the stock's "valuation has become stretched."
    • Investors may have lost sight of "threats to key growth drivers such as Lucentis, Gilenya, and Affinitor," Purcell continues.
    • Lucentis competes with Eylea (REGN) — which is actually seeing slowing sequential sales growth —  and potentially with Squalamine, an eye drop treatment for wet age-related macular degeneration in development (Phase 2) by Ohr Pharmaceuticals (OHRP).
    • Meanwhile, at least one analyst voiced some concern over the summer that Biogen's (BIIB) Tecfidera was cutting into Gilenya's Q/Q growth rates.
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  • Sep. 10, 2013, 9:36 AM
    • Regeneron (REGN +0.8%) names Robert Landry as CFO to replace Murry Goldberg, who's held the role for 18 years and is now becoming Senior VP for Administration ahead of his retirement at the end of next year.
    • Landry was most recently Senior VP and Treasurer at Pfizer, while he has also worked at Wyeth. (PR)
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REGN vs. ETF Alternatives
Company Description
Regeneron Pharmaceuticals Inc is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.
Sector: Healthcare
Industry: Biotechnology
Country: United States