Oct. 28, 2014, 12:46 PM
Oct. 28, 2014, 9:14 AM
- Sanofi (NYSE:SNY) (OTCQB:SNYNF) Q3 results (€M): Total Revenues: 8,781 (+4.1%); Diabetes: 1,799 (+8.3%); Vaccines: 1,451 (+11.2%); Consumer Healthcare: 819 (+12.9%); Genzyme: 649 (+24.6%); Animal Health: 515 (+12.7); Gross Profit: 6,004 (+6.3%); R&D Expense: 1,146 (-3.0%); SG&A Expense: 2,309 (+14.8%); Operating Income: 1,784 (+9.8%); Net Income: 1,190 (+7.8%); EPS: 0.91 (-1.1%).
- Product Sales: Lantus: 1,567 (+8.1%); Plavix: 450 (+9.0%); Lovenox: 426 (+7.2%); Aprovel/Avapro: 178 (-14.8%); Cerezyme: 175 (+9.1%); Renvela/Renagel: 162 (-13.4%); Myozyme/Lumizyme: 138 (+9.4%); Fabrazyme: 116 (+21.9%); Aubagio: 112 (+156.8%); Apidra: 88 (+21.9%); Amaryl: 87 (-2.2%).
- Vaccine Sales: Influenza: 650 (+15.0%); Polio/Pertussis/Hib: 259 (+7.4%); Meningitis/Pneumonia: 191 (-10.0%); Adult Booster: 131 (+54.8%); Other: 121 (+21.8%); Travel & Other Endemic: 99 (-3.0%).
- 2014 Guidance: EPS growth: 6 - 8% (unch).
Oct. 28, 2014, 9:13 AM
Oct. 28, 2014, 7:31 AM
- Sanofi (NYSE:SNY) (OTCQB:SNYNF) is off 8% premarket on moderately higher volume in response to its announcement that sales of its diabetes products will be flat next year due to increased competition in the U.S. CEO Chris Viehbacher says that the firm had to discount Lantus last quarter in order to get on U.S. drug benefit managers' reimbursement lists along with its competitors including Novo Nordisk A/S (NYSE:NVO).
Oct. 28, 2014, 6:52 AM
Oct. 27, 2014, 5:53 AM
- The future of Sanofi (NYSE:SNY) CEO Chris Viehbacher is not on the agenda of a company board meeting today, the firm has said, responding to a report that directors could discuss replacing him.
- However, not being on the agenda doesn't mean that Viehbacher's possible firing won't be discussed.
- Investors wouldn't be happy if Viehbacher were sacked, says one trader. "Such a move would...would be seen as highly negative by the market as Mr Viehbacher has a great track record since he has been at the helm," the trader says.
- Sanofi's shares are -0.4% in Paris.
Oct. 27, 2014, 4:06 AM
- Sanofi's (NYSE:SNY) board could reportedly discuss replacing CEO Chris Viehbacher at a quarterly meeting today.
- Directors are upset at being caught off guard by Viehbacher's attempts to sell an $8B drug portfolio, with some also not happy by his conflicts with the French government over job cuts, poor earnings in 2013, and his move to Boston.
- However, investors "love" Viehbacher, says money manager Jerome Forneris. Sanofi's shares have increased over 150% since Viehbacher became CEO in 2008.
Oct. 21, 2014, 10:52 AM
- The FDA accepts Eli Lilly's NDA for empagliflozin plus immediate-release metformin hydrochloride for the treatment of adults with type 2 diabetes (T2D). The product is part of the Lilly/Boehringer Ingelheim Diabetes alliance portfolio.
- Empagliflozin is a sodium glucose co-transporter-2 inhibitor which removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin decreases the production of glucose in the liver and its absorption in the intestine and improves the body's ability to utilize glucose.
- The FDA approved Jardiance (empagliflozin) as an adjunct to diet and exercise to improve glycemic control in adults with T2D in August 2014. Metformin has been in clinical use for many years.
- Diabetes-related tickers: (JNJ +0.4%)(OTCQB:ISLT)(OTCQB:BTHE +20%)(VTAE +2.5%)(NVO +0.5%)(MRK +0.9%)(NASDAQ:VKTX)(HPTX +0.4%)(ABT +1.2%)(OTCPK:TKPHF)(OTCPK:TKPYY -0.5%)(MDT +1.7%)(SNY -0.2%)(OTCQB:SNYNF -0.5%)(MNKD +2.4%)(ALR +1.4%)(TNDM +3%)
Oct. 21, 2014, 9:08 AM
- Privately-held Boehringer Ingelheim commences patient enrollment in a Phase 3 clinical trial evaluating the safety and efficacy of nintedanib in patients with colorectal cancer refractory to standard treatments. The double-blind randomized, placebo-controlled study will enroll more that 750 patients at 150 sites worldwide.
- Nintedanib (trade name Ofev) is a small molecule tyrosine kinase inhibitor that was recently approved by the FDA for idiopathic pulmonary fibrosis.
- CRC-related tickers: (NASDAQ:GILD) (NYSE:LLY) (NASDAQ:MGNX) (OTCPK:BAYRY) (OTCPK:BAYZF) (NASDAQ:AMGN) (OTC:MKGAF) (NYSE:BMY) (NASDAQ:ONXX) (NASDAQ:IMMU) (NASDAQ:ONCY) (NASDAQ:ARQL) (NYSE:SNY) (OTCQB:SNYNF) (NASDAQ:REGN)
Oct. 20, 2014, 11:44 AM
- The FDA accepts Merck (MRK) and Sanofi's (SNY -0.7%) (OTCQB:SNYNF) BLA for the firms' investigational hexavalent vaccine, DTaP5-IPV-Hib-HepB, for review. If approved, it will be the first pediatric combination vaccine in the U.S. designed to protect children from six diseases: diptheria, tetanus, pertussis, polio, H. influenza type B and hepatitis B.
- The antigens for H. influenza and hep B are from Merck. Sanofi supplied the remaining antigens.
Oct. 20, 2014, 8:56 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) (OTCQB:SNYNF) initiate a Phase 3 clinical trial to assess the safety and efficacy of dupilumab administered concomitantly with topical corticosteroids for the treatment of adults with moderate-to-severe atopic dermatitis (AD). The 16-week randomized, double-blind, placebo-controlled multinational study will enroll ~700 patients.
- Dupilumab is a fully-human mAb that blocks IL-4 and IL-13 signalling. It was created using Regeneron's VelocImmune technology and is being co-developed with Sanofi.
- Dermatitis-related tickers: (NYSE:VRX) (NASDAQ:ANAC) (NYSE:GSK) (NYSE:PRGO)
Oct. 17, 2014, 9:30 AM
- Amgen (NASDAQ:AMGN) files suit in the U.S. District Court of Delaware against Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN) alleging infringement on three of its patents covering monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9). Amgen seeks an injunction to prevent the manufacture, use and sale of Sanofi and Regeneron's PCSK9 inhibitor alirocumab.
- Amgen recently submitted its BLA to the FDA for its PCSK9 inhibitor evolocumab.
Oct. 7, 2014, 8:33 AM
- Danish biopharmaceutical firm Forward Pharma A/S (NASDAQ:FWP) is set for an IPO of 9.5M American Depository Shares at $20 - 22.
- Its lead product is FP187, a proprietary formulation of dimethyl fumarate (DMF) for the treatment of multiple sclerosis (MS), about to enter Phase 3 development.
- Meaningful revenues appear far in the distance, however. Patient recruitment for FP187's Phase 3 trial will take at least 18 months and the completion of the last patient's 48-week treatment will take a total of 30 months.
- The firm's operating losses for 2013 and 1H 2014 were $9M and $7.4M, respectively.
- MS-related tickers: (NASDAQ:BIIB) (NYSE:ABBV) (NYSEMKT:SYN) (NASDAQ:CNCE) (NYSE:SNY) (NASDAQ:XNPT) (NASDAQ:INO) (NASDAQ:OPXA) (NYSE:TEVA) (NASDAQ:ALKS) (NASDAQ:RCPT) (NASDAQ:AVNR) (NASDAQ:GCVRZ) (NYSE:NVS) (NASDAQ:QCOR)
Oct. 7, 2014, 5:03 AM
- Joining the list of pharmaceutical companies that face bribery claims in the Mideast and Africa, Sanofi (NYSE:SNY) has informed the DOJ and SEC about allegations of improper payments to doctors in Kenya and other East African nations.
- "We are committed to maintaining the highest ethical standards wherever we do business," says a company spokesman.
- Sanofi has hired New York law firm Weil Gotshal & Manges to look into the claims and the investigation is continuing.
Oct. 6, 2014, 11:41 AM
- Shares of micro cap Unilife (NASDAQ:UNIS) (OTC:UNISZ) jump 25% on a 6x surge in volume in response to its announcement of a long-term supply agreement with Sanofi (NYSE:SNY) (OTCQB:SNYNF).
- Under the terms of the agreement, Unilife will be the sole provider of cartridge-based wearable injectors for all of Sanofi's applicable large-dose volume drugs, excluding insulins, for a minimum of 15 years. Sanofi will have non-exclusive access to the wearable injectable technology and be allowed to make the technology available to its partners for use with applicable molecules under joint collaborations. Unilife maintains the right to enter into supply agreements with other pharma companies contingent on the preservation of Sanofi's non-exclusive access. Sanofi has the right to extend the agreement for additional periods.
- Unilife expects to receive ~$50M from the partnership, which includes an undisclosed upfront payment.
- Sanofi has five to ten molecules that will be delivered via wearable injectors.
Sep. 30, 2014, 7:20 AM
- Dupilumab, a fully human mAb being co-developed by Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) (OTCQB:SNYNF), met all primary and secondary endpoints in a 60-patient Phase 2a proof-of-concept study in patients with moderate-to-severe chronic sinusitis with nasal polyps who did not respond to intranasal corticosteroids.
- Dupilumab-treated patients demonstrated a statistically significant improvement in the size of nasal polyps which was the primary endpoint. Statistically significant improvements were also observed in the secondary endpoints of objective measures of sinusitis by CT scan, nasal air flow and patient-reported symptoms. Patients in the test group who had asthma demonstrated significant improvements in asthma control.
- Details of the study will be presented at a future medical conference.
- The companies plan to proceed with the clinical development of the drug for this indication.
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