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Biotech Stock Roundup: Geron Soars on $935M J&J Deal, Gilead's Harvoni Approved in the EU - Analyst Blogat Zacks.com (Nov 19, 2014)
at CNBC.com (Nov 17, 2014)
at CNBC.com (Nov 17, 2014)
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
Mon, Feb. 10, 5:30 PM
Mon, Feb. 10, 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)
Wed, Jan. 15, 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
Tue, Jan. 14, 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]."
Tue, Jan. 14, 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)
Thu, Jan. 2, 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).
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.
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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