Sanofi (SNY) - NYSE
  • Tue, May 24, 7:05 AM
    • The FDA approves Holly Springs, NC-based Seqirus' FLUCELVAX QUADRIVALENT, the firs four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people at least four year old. The vaccine helps protect individuals against two influenza A and two B viruses for the current flu season.
    • The traditional flu vaccine is trivalent, consisting of two influenza A viruses and one influenza B strain, although Sanofi's (NYSE:SNY) quadrivalent flu vaccine was approved by the FDA in December 2014 for use in adults.
    • Each year, about 200K Americans are hospitalized due to flu complications.
    • Seqirus was created in July 2015 when bioCSL and Novartis' (NYSE:NVS) influenza vaccines business combined, creating the second largest influenza vaccine company in the world. Novartis sold the business to Australian blood products firm CSL Ltd. in October 2014 for $275M.
    | Tue, May 24, 7:05 AM
  • Mon, May 23, 12:15 PM
    • Sanofi (SNY -1.6%) will need to be prepared to address pointed questions from Advisory Committee members on Wednesday related to the proof of efficacy of its fixed-ratio combination of insulin glargine and lixisenatide for the treatment of patients with type 2 diabetes (T2D).
    • The reviewers appear unconvinced that Sanofi's candidate, which combines a fixed-dose product, the GLP-1 agonist lixisenatide, with a product that requires titration on almost a continuous basis, insulin glargine, is as effective as deploying the drugs sequentially, i.e., on a "add-on" basis. All combination diabetes meds approved to date are either two fixed-dose products (e.g., two oral antidiabetics) or two titratable products (e.g. mixed insulins).
    • In clinical studies, Sanofi "transformed" lixisenatide into a titratable product. To establish the insulin component's contribution to the claimed effect, it compared the titration of the combination to a target fasting glucose goal to the fixed dose of the GLP-1 recommended as safe and effective. To establish the GLP-1 component's contribution to the claimed effect, Sanofi compared the combo product titration to doses of insulin also titrated to a target fasting glucose goal. The reviewers regard this issue as "problematic."
    • The reviewers also question the proposed dosage range of lixisenatide in the combination product since it includes doses that are not effective when used alone. Other areas drawing their attention are the perceived difficulty in switching patients to the combination without a significant reduction in the component they are on and potential medication errors due to the complexity of the combination (e.g., the use of two pens) and pen design (color scheme instead of a blocking mechanism to prevent under-dosing).
    • FDA briefing doc
    • Sanofi briefing doc
    • Erratum to Sanofi doc 
    | Mon, May 23, 12:15 PM
  • Mon, May 23, 11:04 AM
    • The FDA has a busy docket this week with two Ad Comm meetings and four product approval decisions.
    • On Tuesday, the Circulatory System Devices Panel of the Medical Devices Advisory Committee will discuss the Premarket Approval Application (PMA) from St. Jude Medical (STJ -0.2%) seeking approval of its AMPLATZER Patent Foramen Ovale (PFO) Occluder, a permanent cardiac implant for PFO closure indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic (uncertain origin) stroke due an embolism presumed to have originated through an opening in the heart.
    • On Wednesday, the Endocrinologic and Metabolic Drugs Advisory Committee will review the NDAs for Sanofi's (SNY -1.3%) fixed ratio combination of insulin glargine and lixisenatide for the treatment of adults with type 2 diabetes.
    • No later than Thursday, the FDA will decide on Sarepta Therapeutics' (SRPT +2.3%) New Drug Application (NDA) seeking approval of eteplirsen for children with Duchenne muscular dystrophy amenable to skipping exon 51. Also, no later than Thursday, it will decide on AstraZeneca's (AZN -0.3%) NDA seeking approval of ZS-9 for hyperkalemia.
    • No later than Friday, the agency will decide on Titan Pharmaceuticals' (TTNP +8.8%) NDA seeking approval of its Probuphine subdermal implant for the maintenance treatment of opioid addiction. Also, no later than Friday, it will decide on Vanda Pharmaceuticals' (VNDA +0.3%) supplemental NDA seeking approval of Fanapt for the maintenance (long term) treatment of schizophrenia in adults.
    | Mon, May 23, 11:04 AM
  • Sun, May 22, 9:13 AM
    • Health officials said 279 pregnant women in the U.S. and its territories have tested positive for Zika infection, prompting a new call from President Obama for more funding to fight the outbreak spreading through the Americas.
    • Obama wants Congress to provide close to $1.9B for vaccine development, faster diagnostic tests, and new tools for killing the mosquitoes that carry the virus, which is linked to a rare birth defect in newborns and neurological disorders in adults.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Sun, May 22, 9:13 AM | 49 Comments
  • Thu, May 19, 2:50 AM
    • The World Health Organization is sounding off another Zika alarm, stating the virus is likely to spread to parts of Europe this summer, although the likelihood of an outbreak is low to moderate.
    • Areas most at risk include the Black Sea coast of Russia and Georgia and the island of Madeira.
    • Countries with a moderate risk include France, Spain, Italy and Greece, while the threat in the U.K. is low.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Thu, May 19, 2:50 AM | 15 Comments
  • Wed, May 18, 2:44 AM
    • More than three months after President Obama asked for $1.8B in emergency funds to combat the Zika virus, the Senate took its first step to approve the request by passing a compromise $1.1B measure.
    • At the same time, the White House issued a veto threat against a House Republicans' bill that would provide only $622M, a figure the White House called "woefully inadequate" to fight the rapidly spreading disease.
    • Related tickers: SNY, INO, AEMD, XON, CEMI, BCRX, TMO, OTCQB:GOVX
    | Wed, May 18, 2:44 AM | 22 Comments
  • Fri, May 13, 11:35 AM
    • Prothena (PRTA +7.6%) initiated with Overweight rating and $60 (44% upside) price target by Barclays.
    • Pfizer (PFE +0.5%) initiated with Hold rating and $38 (12% upside) price target by Berenberg.
    • Amarin (AMRN +1.9%) initiated with Buy rating and $3.50 (111% upside) price target by Jefferies.
    • Align Technology (ALGN +0.9%) initiated with Outperform rating and $84 (10% upside) price target by Credit Suisse.
    • Presbia (LENS +2.9%) initiated with Buy rating and $14 (254% upside) price target by Rodman & Renshaw.
    • LabStyle Innovations (OTCQB:DRIO +5.4%) initiated with Buy rating and $12 (121% upside) price target by Rodman & Renshaw.
    • Juno Therapeutics (JUNO +1.5%) initiated with an Outperform rating and $55 (48% upside) price target by Cowen & Co.
    • WebMD Health (WBMD +0.4%) upgraded to Buy from Neutral by SunTrust Robinson Humphrey. Price target increased to $75 (18% upside) from $57.
    • Sanofi (SNY +0.3%) upgraded to Overweight from Equal Weight by Barclays. Price target maintained at €84 (20% upside).
    • Depomed (DEPO +4.1%) upgraded to Buy from Neutral by Mizuho Securities. Price target raised to $19 (4% upside) from $18.
    | Fri, May 13, 11:35 AM
  • Wed, May 11, 9:12 AM
    • Health insurer Cigna (NYSE:CI) enters into new value-based agreements with Amgen (NASDAQ:AMGN) and Sanofi (NYSE:SNY)/Regeneron Pharmaceuticals (NASDAQ:REGN) covering their cholesterol-lowering medications, Repatha (evolocumab) and Praluent (alirocumab), respectively. The contracts modify the cost of the pricey meds based on how well patients respond to the drugs. If they meet or exceed the expected reduction in LDL-C (the "bad" cholesterol) the original negotiated price remains as is. If they fall short of the expected LDL-C reduction, the discount increases.
    • Repatha lists for $14,000 per year while Praluent lists for $14,600. Cigna will also determine whether there are cardiovascular improvements related to treatment by analyzing medical and pharmacy claim data.
    • Cigna is the first payer to close this type of agreement with the drug makers covering their PCSK9 inhibitors. It also has value-based contracts in place covering drugs for heart failure, diabetes, multiple sclerosis and hepatitis C.
    | Wed, May 11, 9:12 AM | 5 Comments
  • Fri, May 6, 10:32 AM
    • Baxter International (BAX -1.1%) initiated with Buy rating and $51 (13% upside) price target by Evercore ISI.
    • Intrexon (XON +2.3%) initiated with Market Outperform rating and $42 (62% upside) price target by JMP Securities.
    • Heron Therapeutics (HRTX -8.8%) initiated with Buy rating and $41 (143% upside) price target by Cantor Fitzgerald.
    • Dr. Reddy's Laboratories (RDY -2.5%) initiated with Neutral rating and Rs.3,334 price target (8% upside) by Goldman Sachs.
    • Aeglea BioTherapeutics (AGLE +7.4%) initiated with Buy rating and $12 (33% upside) price target by UBS.
    • Cardiome (CRME +34.9%) upgraded to Speculative Buy from Hold by Mackie Research. Price target raised to $8.60 (58% upside) from $5.20.
    • Medivation (MDVN +1.2%) upgraded to Buy from Neutral by Citigroup. Price target raised to $73 (22% upside) from $37.
    • Masimo (MASI -0.3%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $52 (13% upside) from $43.
    • GlaxoSmithKline (GSK -1%) upgraded to Buy from Reduce by Oddo & Cie.
    • Cogentix Medical (CGNT -1%) downgraded to Neutral from Buy with a price target of $1.15 (14% upside) by Roth Capital.
    • Bruker (BRKR +0.8%) downgraded to Neutral from Outperform by BTIG Research.
    • Relypsa (RLYP -4%) downgraded to Underperform from Neutral by Mizuho Securities. Price target cut to $31 (132% upside) from $34.
    • Molina Healthcare (MOH -0.7%) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $45 (0% upside) from $75. Downgraded to Neutral from Buy by UBS. Price target lowered to $54 (20% upside) from $76.
    • Sarepta Therapeutics (SRPT +1.8%) downgraded to Underperform from Market Perform by Leerink Swann. Price target lowered to $5 (71% downside risk) from $13.
    • Sanofi (SNY -0.4%) downgraded to Hold from Buy with an €81 (15% upside) price target by HSBC.
    | Fri, May 6, 10:32 AM | 4 Comments
  • Thu, May 5, 12:07 PM
    • The anticipated rapid ramp of Regeneron Pharmaceuticals (REGN +5.3%) and Sanofi's (SNY -3%) cholesterol fighter Praluent (alirocumab) and Amgen's (AMGN +0.2%) Repatha (evolocumab) remains elusive in the face of headwinds from insurers over the high costs of the PCSK9 inhibitors. The companies and bullish analysts have touted both meds as blockbusters that will eventually generate well over $1B a year in sales. When is anyone's guess considering Repatha's Q1 sales of $16M and Praluent's $13M, both shy of expectations.
    • Regeneron says that 74% of U.S. commercially insured lives and 91% of Medicare insured lives have access to its drug (as of April 1). The premium list price of $14,600 per year, significantly more expensive that other therapies like statins, has prompted insurers to restrict access via specific utilization criteria and burdensome paperwork. The company expects payers to loosen the strings a bit when when upcoming data are released on Praluent's cardiovascular benefits.
    • Amgen is in the same boat. Repatha is priced at $14,000 per annum before discounts.
    • Another cloud hanging over Praluent's prospects is a patent dispute versus Repatha, currently under appeal after Amgen prevailed in March.
    | Thu, May 5, 12:07 PM | 6 Comments
  • Thu, May 5, 11:38 AM
    • Move over Sanofi (SNY -3.3%), Pfizer (PFE +0.4%) and AstraZeneca (AZN -0.8%). Sources say Amgen (AMGN +0.1%) is considering a bid for Medivation (MDVN +0.2%). One thing appears certain: Sanofi needs to sharpen its pencil if it intends to close the deal. Its bid of $52.50 appears woefully short.
    | Thu, May 5, 11:38 AM | 11 Comments
  • Thu, May 5, 9:14 AM
    • In a letter to Medivation's (NASDAQ:MDVN) board, Sanofi (NYSE:SNY) CEO Olivier Brandicourt reiterates his firm's strong desire to negotiate the terms of an acquisition, saying its $9.3B offer ($52.50 per share) represents a tidy 50% premium over what shares were trading three months before.
    • He also says Sanofi has had extensive discussions with Medivation's top shareholders and they back the deal. Going a step further, he says Sanofi is prepared to go directly to shareholders if management does not proceed.
    • A competing bid appears likely [Pfizer (NYSE:PFE), AstraZeneca (NYSE:AZN)] so whatever Medivation decides to do, Sanofi will probably have to up its offer.
    • MDVN is up a fraction premarket while SNY is down 3%.
    • Update: Medivation reiterates that Sanofi's bid is "substantially inadequate."
    | Thu, May 5, 9:14 AM | 21 Comments
  • Tue, May 3, 6:34 PM
    • Medivation (NASDAQ:MDVN) +3.9% AH following a Reuters report that Pfizer (NYSE:PFE) has approached the company to express interest in an acquisition, raising the possibility of a bid rivaling Sanofi's (NYSE:SNY) $9.3B offer by Sanofi.
    • MDVN has not yet decided whether it should engage with PFE in negotiations and is in discussions with its financial and legal advisers, according to the report.
    • MDVN last week rejected SNY's $52.50/share takeover proposal, and PFE, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN) have been speculated as potential suitors.
    | Tue, May 3, 6:34 PM | 5 Comments
  • Fri, Apr. 29, 3:09 PM
    • Also mentioned alongside AZN and PFE as weighing bids for Medivation (MDVN +2.3%) is Novartis (NYSE:NVS), according to the report.
    • Earlier today, Medivation rejected Sanofi's (SNY -4.6%) $9.3B, or $52.50 per share offer, with one of Bloomberg's sources saying the company is looking for at least $65 per share. Sanofi has the capacity to go higher, say sources, but is naturally reluctant to overpay.
    | Fri, Apr. 29, 3:09 PM | 9 Comments
  • Fri, Apr. 29, 11:25 AM
    • As expected, Medivation (MDVN -0.7%) says no to Sanofi's (SNY -4.6%) $9.3B offer ($52.50 per share) saying it "undervalues" the firm.
    • In a statement, Sanofi says it remains committed to the merger and looks forward to engaging directly with MDVN shareholders regarding its offer. Looks like the bid is turning hostile.
    | Fri, Apr. 29, 11:25 AM | 5 Comments
  • Fri, Apr. 29, 9:54 AM
    • Sanofi (SNY -3.6%) Q1 results (€M): Total Revenues: 8,543 (+0.7%); Sanofi Genzyme: 1,169 (+20.5%); Diabetes & Cardio (ex. emerging markets): 1,499 (-5.8%); General Medicines & Emerging Markets: 4,490 (-4.3%); Sanofi Pasteur (Vaccines): 625 (+8.2%); Merial (Animal Health): 760 (+17.5%). Consensus: $9.94B.
    • Sales by Franchise: Specialty Care: 1,371 (+18.4%); Diabetes & Cardio: 1,832 (-3.5%); Established Products: 2,591 (-8.2%); Consumer Healthcare: 905 (-3.1%); Generics: 459 (+3.3%); Vaccines: 625 (+8.2%); Animal Health: 760 (+17.5%).
    • Net Income: 1,087 (+6.3%); EPS: 0.84 (+7.7%). Consensus: 0.77.
    • Key Product Sales: Lantus: 1,395 (-11.0%); Lovenox: 404 (-3.9%); Plavix: 388 (-18.2%); Aubagio: 279 (+64.1%); Renvela/Renagel: 234 (+2.7%); Cerezyme: 182 (+3.7%); Allegra: 140 (0.0%).
    • 2016 Guidance: EPS: flat; currency impact: -3%.
    • Q2 Consensus: EPS of $0.76 on revenues of $10.38B.
    | Fri, Apr. 29, 9:54 AM | 1 Comment
Company Description
Sanofi engages in the research, production and distribution of pharmaceutical products. It operates through the following segments: Pharmaceuticals, Human Vaccines, Animal Health, and Others. The Pharmaceuticals segment includes research, development, production and sales activities relating to... More
Sector: Healthcare
Industry: Drug Manufacturers - Major
Country: France