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The FDA Breakthrough Designation Further Validates Regeneron's Pipeline
- A research based company's pipeline determines its fate going forward.
- Early positive clinical results can give an investor an early read as to the future path of the company's share price.
- The recent string of high profile successes have stoked my bullish fervor even more.
Regeneron Pharmaceuticals Offers More Upside Than Gilead Sciences
- Regeneron continues to perform as the shares continue their ascent higher.
- The company's main compounds continue to show significant promise in Phase III testing.
- Sanofi holds over 20% of the shares outstanding offering a built in suitor if the compounds deliver on their promise.
- I expect the shares to potentially outperform Gilead Sciences in 2015 as will be detailed below.
Regeneron Plunges In What Barron's Calls A Significant Disappointment: My Analysis
- Regeneron missed some analysts' expectations for sales and EPS, sparking a nearly 6% sell-off in the shares.
- Barron's jumped on the bearish bandwagon.
- Yet the bull case for Regeneron continues to strengthen, as this article discusses.
- Regeneron's shares went up by more than 30% year-to-date, despite the tumbling performance of the entire biotechnology sector.
- According to analysts at UBS, Regeneron's blockbuster drug EYLEA's sales are expected to hit $3.7 billion by 2020.
- Regeneron received Breakthrough Therapy designation for EYLEA for the treatment of patients suffering from diabetic retinopathy.
- Once approved, Regeneron and Sanofi's drug, Alirocumab, could hit more than $4 billion in annual sales.
- Regeneron is a biotech company which gave me a great return in a short amount of time and I just wanted to lock up some profits in the name.
- Regeneron was beaten down quite a bit on the back of profit taking just the week before the Alibaba IPO, presenting an excellent opportunity to buy back in.
- I fear there may be a slowdown in construction in America that it made me want to close my position in United Rentals.
There Is Further Upside Potential In Regeneron Pharmaceuticals
- Regeneron Pharmaceuticals is up more than 25% this year.
- The company, along with Sanofi, recently bought priority review voucher for alirocumab FDA submission.
- With the voucher, alirocumab has the chance to beat Amgen’s evolocumab to the market.
- Based on the huge potential for PCSK9 inhibitors and EYLEA sales, which remain on track, Regeneron still has further upside potential.
Challenging Consensus On PCSK9 Inhibitors: Focus On Regeneron And Amgen
- Amgen has filed for approval the first of a new class of proteins to lower LDL cholesterol.
- These PCSK9 inhibitors are expected to see Amgen's evolocumab and Regeneron/Sanofi's alirocumab reach market within a year.
- Enough information has been released to allow preliminary analysis of the commercial potential of these drugs and the entire class.
- One factor to consider is insider accumulation at Regeneron.
- Regeneron has just announced a surprise data release on its main pipeline drug over the Labor Day weekend.
- I speculate that the news will be favorable.
- The stock is acting well and Regeneron has been doing well operationally.
- Valuation may explain why there is a decent short position on the stock, but the shorts may be getting uncomfortable now.
- Regeneron announced an upside surprise for sales of its lead product Eylea this week.
- It has a powerful pipeline and important collaborations with Sanofi and Bayer HealthCare.
- The combination of high R&D spending and elevated pre-launch expenses for its late-stage cholesterol reducer alirocumab means that P/E is the wrong metric investors should look at.
- Sales of Regeneron's highest selling medication, Eylea, are expected to rise rapidly over the next few years as it gains market share.
- Eylea is expected to be approved by the FDA to treat diabetic macular edema.
- Long-term partner Sanofi increased its stake in Regeneron to 22.5%.
- High research spending and a diverse pipeline of potential products should help Regeneron get more drugs to market.
If You Want GARP, Look Into Biotech, Not Utilities, But Do The Valuations
- If there is a rotation in stocks, it is more apparently from high growth into low growth than into quality.
- Just look at revenue growth versus multiple expansion over the past 2.5 years among top biotechs being sold off, and you'll see what I mean.
- The biotech selloff is at best indiscriminate, at worst contrived to rock others out of the boat.
Why Regeneron Pharmaceuticals Has A Bright Future Ahead
Tue, Jul. 29, 7:25 PM
- Following positive Phase 3 trial data, the FDA has approved Regeneron's (NASDAQ:REGN) Eylea for the treatment of diabetic macular edema (DME).
- Eylea is already available in the U.S. for the treatment of neovascular age-related macular degeneration and macular edema following central retinal vein occulusion, following 2011 and 2012 approvals.
- Europe's CHMP has given a positive opinion for approving Eylea for DME treatment, and regulatory submissions for DME treatment have also been made in Japan, Asia-Pac, and Latin America.
- REGN +3.1% AH.
- Prior Eylea coverage
Fri, Jul. 18, 7:24 AM
- In a Phase 3 clinical trial comparing the safety and efficacy of Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) to laser photocoagulation in patients with diabetic macular edema, those receiving injections of Eylea showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100.
- Study subjects receiving Eylea 2 mg every month had a mean change in BCVA from baseline of 11.4 letters (mean change at 52 weeks was 10.5 letters). Subjects receiving Eylea 2 mg every 2 months after receiving five monthly injections showed a mean change in BCVA from baseline of 9.4 letters (down from 10.5 letters at 52 weeks). Subjects receiving laser coagulation showed a mean change in BCVA from baseline of 0.7 letters (1.2 letters at 52 weeks).
- 31.1% of the Eylea test group dosed every 2 months achieved an increase of at least 15 letters (~3 lines of vision) compared to 38.2% of the Eylea group dosed monthly compared to 12.1% of the laser group.
- The two-year data will be presented at upcoming medical conferences.
Wed, Jul. 9, 5:22 PM
- Regeneron (REGN +0.1%) and development partner Sanofi (SNY +0.8%) report encouraging Phase 2b results for their investigational mAb dupilumab as a treatment for adults with moderate-to-severe atopic dermatitis. All doses of dupilumab met the primary endpoint of a greater improvement in Eczema and Severity Index (EASI) scores from baseline compared to placebo. The mAb works by blocking the signaling of IL-4 and IL-13, two cytokines that play important roles in the pathogenesis of moderate-to-severe atopic dermatitis.
- At week 16 in the 380-patient study, 12 - 33% of the test group achieved clearing or near-clearing of skin lesions and experienced a 16.5 - 47% reduction in itching.
Fri, Jun. 27, 8:42 AM
- Europe's Committee for Medicinal Products for Human Use (CHMP) recommends that the European Medicines Agency (EMA) approve Regeneron Pharmaceuticals' (REGN) Eylea (aflibercept) injection as a treatment for visual impairment due to diabetic macular edema (DME). Eylea is currently approved as a treatment for neovascular (wet) age-related macular degeneration (AMD) and macular edema following central retinal vein occlusion (CRVO).
- Regeneron and Bayer Healthcare (BAYRY) (BAYZF) are collaborating on the global development of Eylea. Regeneron has exclusive rights to the product in the U.S. while Bayer Healthcare has the license for exclusive marketing rights ex. U.S. where the companies equally share the profits from Eylea sales. In Japan, Regeneron receives a percentage of net sales.
Thu, Jun. 12, 9:50 AM
- In a 1,197-subject Phase 3 clinical trial evaluating the safety and efficacy of sarilumab in patients with moderate-to-severe rheumatoid arthritis (RA) who have not responded adequately to methotrexate (MTX) therapy, the mAb met all three co-primary endpoints: demonstrating improvement in disease signs and symptoms at 24 weeks, physical function at 16 weeks and inhibition of joint damage progession at 52 weeks. All results were statistically significant.
- On a secondary endpoint, sarilumab combined with MTX showed a statistically significantly greater effect than MTX alone in achieving a major clinical response for at least 24 weeks.
- Sarilumab is a human mAb that is an IL-6 inhibitor. By blocking the binding of IL-6 to its receptor, it interrupts the resultant cytokine-mediated inflammatory signalling.
- Sarilumab is being co-developed by Regeneron Pharmaceuticals (REGN -0.2%) and Sanofi (SNY).
Wed, Jun. 11, 7:23 AM
- Regeneron Pharmaceuticals (REGN) reports that collaboration partner Bayer HealthCare (BAYZF) (BAYRY) has submitted an application to the EMA for marketing authorization in the European Union for Eylea (aflibercept) for the treatment of macular edema following branch retinal vein occlusion (BRVO).
- The U.S. FDA approved the drug for the treatment of wet Age-related Macular Degeneration (AMD) in November 2011 and for Central Retinal Vein Occlusion (CRVO) in September 2012. The EMA has also approved Eylea for wet AMD and Macular Edema following CRVO.
- Regulatory submissions have been made to the FDA for Macular Edema following BRVO and in the EU for Diabetic Macular Edema.
- Regeneron has exclusive rights to Eylea in the U.S. Bayer HealthCare has exclusive marketing rights ex-U.S. (the companies equally share the profits). In Japan, Regeneron receives a percentage of sales.
Thu, May. 8, 7:24 AM
- Regeneron Pharmaceuticals (REGN) total revenues: $626M (+42.3%); collaboration revenues: $256M (+124.6%); net product sales: $362M (+13.5%); Eylea sales: $359M (+14.3%); Arcalyst sales: $3M (-40%); operating income: $186M (+21.5%); net income: $65.4M (-33.9%); EPS: $0.58 (-35.6%); quick assets (ex-A/R): $1.2B (+9.1%).
- Eylea PDUFA date for macular edema indication is August 18, 2014.
- Eylea PDUFA date for macular edema following branch retinal vein occlusion indication is October 23, 2014.
- Fifteen human monoclonal antibodies generated by the company's VelocImmune technology are in clinical development, including eight with Sanofi (SNY).
Thu, May. 8, 6:31 AM| Comment!
Mon, May. 5, 8:55 AM
- Regeneron Pharmaceuticals (REGN) and Avalanche Biotechnologies ink a collaboration deal to discover, develop and commercialize gene therapy products focused on ophthalmologic diseases. The agreement covers novel gene therapy vectors and proprietary molecules discovered jointly by the partners and developed by Avalanche's Ocular BioFactory, a gene therapy discovery platform based on adeno-associated virus technology.
- Avalanche will receive an upfront cash payment, milestone payments of up to $640M and royalties of global net sales of post-approval products.
- Regeneron will have exclusive worldwide rights for each product it moves forward in clinical development. It also has a time-limited right of first negotiation for certain rights to AVA-101, Avalanche's vascular endothelial growth factor gene therapy product for wet age-related macular degeneration. The rights negotiation time window starts when the ongoing Phase 2a clinical trial ends.
- The collaboration covers eight therapeutic targets.
Mon, Mar. 24, 7:27 PM
- As U.S. corporations sit on $1T-plus in cash and with many facing organic growth challenges, Morgan Stanley lists 44 multi-billion dollar cap companies it thinks have a high likelihood of receiving at least one tender offer over the next 12 months.
- In the energy sector: NFX, SD, TDW.
- In materials: CLF, AXLL, UFS, RGLD.
- Consumer discretionary: SBGI, WEN, TPX, EAT, BYI, DWA, JCP, AEO.
- Consumer staples: INGR, HAIN, HSH, WWAV.
- Health care: CELG, ESRX, WLP, REGN, ALXN, AET, CI, BDX, CERN.
- Financial: NSM.
- Tech: BRCD, ONNN, TIBX, SPWR, IM, JBL, SUNE, TER, ARRS, NSR.
- Telecom: CCI, SBAC, LVLT, WIN, FTR.
Fri, Mar. 7, 4:24 PM
- The FDA requests that Regeneron (REGN) and Sanofi (SNY) assess potential neurocognitive side effects of their late stage cholesterol drug alirocumab, a PCSK9 inhibitor.
- Memory loss, impaired concentration and paranoia, though rare, have been associated with the use of statins for lowering LDL cholesterol.
- Both firms disclosed in their regulatory filings that the appearance of these side effects could delay or stop the product's development.
- Pfizer (PFE) and Amgen (AMGN) are also working on PCSK9 inhibitors.
Mon, Mar. 3, 10:20 AM
- Bayer (BAYRY) has filed for Japanese approval of Regeneron's (REGN) Eylea therapy for treating patients with diabetic macular edema, the companies have said. Bayer has the rights to sell Eyelea outside the U.S.
- The submission is based on Phase 3 clinical trials that proved a statistically significant improvement in best-corrected visual acuity from baseline at 52 weeks compared with laser photcoagulation.
- The companies didn't provide a timetable for marketing approval, although the process is usually slower than with the FDA in the U.S. (PR)
Fri, Feb. 28, 7:37 AM
- Bayer believes that Xarelto (blood thinner) and Eylea (eye), which is developed by Regeneron (REGN), will hit peak revenues in 5-6 years. Bayer holds the license to sell Eylea outside the U.S.
- Bayer has increased its combined peak annual sales forecast for its five most important drugs - Adempas (lung), Stivarga (cancer) and Xofigo (cancer), as well as Eylea and Xarelto - to at least €7.5B from a prior forecast of €5.5B. The treatments generated sales of €1.52B in 2013.
- See Bayer's earnings
Mon, Feb. 24, 9:18 AM
- The FDA has accepted Regeneron's (REGN +3.3%) application to expand the use of its Eylea therapy to treat 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.
- Regeneron's application follows a successful Phase III trial.
- Eylea has already been authorized for other indications, including wet age-related macular edema.
Tue, Feb. 11, 4:48 PM
- Regeneron's (REGN) 7.4% gain topped today's S&P leader board following Q4 earnings which featured good news on the company’s blockbuster-to-be, Eylea.
- Q4 U.S. sales of the sight-saving drug rose 46% Y/Y to $402M, and REGN forecasts U.S. sales to reach $1.7B-$1.8B this year as it expects the drug to win approval for newer uses.
- RBC Capital thinks Eylea sales could be better than forecast, given that management is typically viewed as conservative when it comes to guidance.
- Brean Capital raises its price on shares to $380 from $367, as it looks to several Phase 3 trials for alirocumab - part of a new class of injectable cholesterol medicines - reading out around mid-2014; the firm views the drug as the next major value driver.
Tue, Feb. 11, 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)
REGN vs. ETF Alternatives
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