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There are 3 articles on this stock available only to PRO subscribers.
Sanofi's New Medicines Seminar: Implications For Afrezza
- Sanofi's presentation to analysts today put the heaviest emphasis on several not-yet-approved drugs rather than Afrezza.
- They have good business reasons for doing this.
- Afrezza has a much easier path to success than the drugs that got the most attention.
- While there was little new information about Afrezza the market size estimate is very encouraging.
- The end of an era for CEO Chris Viehbacher did not reflect well on the stock price.
- Lantus' era of monopoly is too coming to an end. It is Sanofi's leading revenue generator.
- The company's weak guidance added to the pressure on the stock price, but there were significant positives performance wise.
- The company has some interesting activity going on in its product line-up as it prepares for an influx of Lantus generics in the near future.
- With the recent plunge now could be an ideal time to take a keen look at the stock as it present a compelling opportunity for growth.
Digesting Sanofi's Two Pieces Of News- Lantus' Challenging Outlook And The CEO Dismissal
- Sanofi has wide economic moat derived from four competitive advantages.
- The market has overreacted to the flat outlook of the company’s diabetes business as Lantus’ sales decline is unlikely to change the company’s fundamentals.
- The abrupt CEO removal should be a bigger concern to investors as it may mark a cultural and strategic shift.
- Currently, the shares are undervalued. However, investors should demand a greater margin of safety due to the company’s uncertain outlook.
- Sanofi removed its CEO in a very ugly manner.
- The decision seems to be a roadblock for Sanofi's transition into a more international corporation.
- As my investment case was partly based on multiple expansion, which I consider unlikely at this point, I am reducing my intrinsic value estimate.
Update: Sanofi Will Deliver Growth, But Later Than Expected
- A good quarter was obfuscated by the announcement that pricing pressures in the US will stall growth of the Diabetes division.
- As Diabetes delivers probably more than 34% of Sanofi's profits, investors sold off their shares in early trading.
- I continue to be optimistic for the French drug maker in the long term, but recognize that investors will have to wait a bit longer for stronger growth.
Sanofi Vs. MannKind - Afrezza Is Better For Sanofi
- Sanofi, with a wide moat and 3.5% yield, offers investors more attractive exposure to the launch of Afrezza and the overall diabetes care market than does MannKind.
- Afrezza will have a great impact on Sanofi's undervalued drug portfolio, and showcase the company's strengths: a global client network and one of the industry's largest sales forces.
- Patent expiration has plagued the stock for a while, but shares have rallied since the August 11 partnership with MannKind was announced and still look cheap @ 7x forward EPS.
- My conservatively constructed 6-year model for Afrezza's sales and Sanofi estimate that shares are 22% below fair value.
Sanofi's New Drug Is Potentially A Game Changer
- Sanofi has developed a dengue vaccine which produced excellent results in clinical trials.
- The company’s top-selling drug, Lantus, is about to lose its patent and the drug’s biosimilars have received approval from regulatory authorities.
- Sanofi has developed an effective Lantus successor that is expected to absorb losses from Lantus’s patent expiry.
- The company offers a considerably better dividend yield than its industry peers and is currently trading at a discount.
Sanofi: Stiff Competition Will Impact Future Performance
- Eli Lilly and Boehringer Ingelheim’s biosimilar version of Lantus has been approved by the EMA under the market name of Abasria.
- Abasria has received tentative approval in the US but will be held off until 2016 due to the lawsuit filed by Sanofi against Eli Lilly.
- Novo Nordisk’s Tresiba will have first-mover advantage with its insulin/GLP1 combination drug in the US.
- Sanofi and Regeneron Pharmaceuticals announced encouraging results from the Phase 3 study of their drug Alirocumab. It could be the next multi-billion dollar product.
- Sanofi reported decent second-quarter results with stable sales, improving margins and increasing earnings per share.
- Sanofi has several blockbuster drugs to address unmet needs that are in its late-stage pipeline or awaiting regulatory approval.
- The company has a continued history of rewarding its shareholders in the form of dividend payment and share buybacks.
Sanofi Should Be Part Of Your Portfolio If You Want Higher Returns
- Despite stable earnings, Sanofi reported positive growth in earnings per share courtesy of improved margins.
- Its robust pipeline will increase earnings and shareholder value.
- The Genzyme deal with Alnylam will further strengthen the company's drug portfolio.
- With a strong pipeline and products waiting approval, I expect that the stock has yet to reach its peak.
- Sanofi's vaccine business was the only company division to show a sales decrease in the first half of 2014.
- A large late-stage clinical trial shows Sanofi's high-dose flu vaccine more effective than the standard dose among older persons, who are more vulnerable to the virus.
- Sanofi has several vaccine candidates, some addressing unmet medical needs, in late-stage trials or awaiting regulatory approval.
Sanofi Appears To Be In The Early Stages Of An Earnings Rebound
- Patent expiries restrained earnings and share-price gains the last several years.
- Sales erosion stemming from generic copies are now mostly in the rear-view mirror.
- Investors seem a little late in recognizing the unfolding of an earnings recovery.
- An above-average dividend yield adds to the stock's appeal.
Sanofi: Confronting Lantus Patent Expiry With More Efficient Successor ToujeoBalanced Investing • Thu, Aug. 7
- Sanofi received the US FDA’s acceptance for reviewing its New Drug Application for investigational basal insulin, Toujeo. The filing was also accepted by the EMA for EU countries.
- Sanofi submitted a lawsuit against Eli Lilly for infringing seven patents related to insulin and insulin-injecting devices. This lawsuit trial will keep Lantus’s generic version off market until mid-2016.
- Toujeo is an improved version and has triple concentration of insulin glargine as Lantus.
- Prevailing hindrances that are blocking Sanofi’s rivals from entering diabetes basal insulin market, where it has 80% market share, is likely to help Sanofi in sustaining its market lead.
- In the middle of a sharply correcting stock market, Sanofi rose strongly after a better than expected earnings report.
- Investors are probably getting increasingly confident that the company has finally left behind the patent cliff and is well-positioned for growth.
- In my October 2013 analysis, I had estimated FCF growth to over €6-7 per share in the next few years which I still expect to be reached.
- Almost 29.1 million of the US population (9.3% of the total population) are suffering from diabetes.
- Toujeo reduced the rate ratio of experiencing low blood sugar levels during nighttime use by 31% while its rate ratio during daytime use was reduced by 14%.
- Novo’s degludec offered much better efficacy as compared to Sanofi’s Toujeo.
- Merck and Eli Lilly, among others, are all set to introduce Lantus’ biosimilars as soon as its patent expires.
Can Once Daily GLP-1 Lyxumia Be The Next Major Growth Driver For Sanofi?
- Lyxumia's fortune hinges on results from ELIXA, a cardiovascular outcome study to report data in early 2015.
- Currently consensus forecasts for Lyxumia do not assume a positive outcome from the ELIXA study.
- I believe there is a good chance that ELIXA will report positive data. In such a scenario the consensus estimates for Lyxumia will increase from $450m to $2.9b.
Fri, Nov. 21, 8:04 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of Celgene's (NASDAQ:CELG) Otezla (apremilast) for two indications: 1. the treatment of adult patients with moderate-to-severe plaque psoriasis who failed to respond to, or who are contraindicated for or are intolerant to, other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA); 2. alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. A final decision from the European Commission usually takes about 60 days.
- Apremilast is a PDE4 inhibitor specific for cyclic AMP (cAMP). PDE4 inhibition results in increased cAMP levels which is thought to indirectly modulate the production of inflammatory mediators.
- The FDA approved Otezla in March.
- Previously: FDA approves Otezla
- Previously: Otezla label expansion cleared in the U.S.
- Related tickers: (NYSE:PFE) (NYSE:SNY) (OTCQB:SNYNF) (NYSEMKT:PLX) (NASDAQ:SHPG)
Fri, Nov. 21, 7:38 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval for Genzyme's (NYSE:SNY) (OTCQB:SNYNF) Cerdelga (eliglustat) capsules for the treatment of certain adults with Gaucher disease type 1. A final decision by the European Commission usually takes about 60 days.
- The FDA approved Cerdelga in August. It was the first oral therapy approved as a first-line treatment for Gaucher.
- Previously: FDA approves new drug for Gaucher's disease
- Related tickers: (NYSE:PFE) (NYSEMKT:PLX) (NASDAQ:SHPG)
Thu, Nov. 20, 8:16 AM
- The FDA grants Breakthrough Therapy status to Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NYSE:SNY) (OTCQB:SNYNF) dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. Dupilumab is currently in Phase 3 development.
- The Breakthrough Therapy designation includes all of the Fast Track features as well as more intensive FDA guidance and discussion including access to more senior agency managers.
Thu, Nov. 20, 3:46 AM
- Sanofi (NYSE:SNY) is expecting to launch 18 new drugs by 2020, a move that the company says could boost sales by up to €30B ($37.6B) over five years.
- Sanofi execs will lay out the strategy for bringing the new drugs to market later today, in a bid to win over investors surprised at the sudden ouster of its chief executive and problems in the field of diabetes.
- The company expects to launch six new medicines in 2015 and another one every six months from 2016 to 2018.
Wed, Nov. 19, 12:35 PM
- During the scientific sessions at the American Heart Association meeting in Chicago, investigators presented results from six Phase 3 clinical trials of Regeneron Pharmaceuticals (REGN +1.2%) and Sanofi's (SNY -0.2%) (OTCQB:SNYNF) cholesterol-lowering product candidate, alirocumab, compared to placebo or statins.
- The trials assessed alirocumab in patients with hypercholesterolemia who were at high cardiovascular risk, had an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH) and/or a history of intolerance to two or more statins. All six studies met their primary efficacy endpoint of change from baseline in LDL-C at week 24. Patients receiving alirocumab showed a mean reduction in LDL-C from baseline of 36 - 62%, depending on the study, compared to the comparator drugs' mean reduction of 0.5 - 23%.
- Regulatory submissions will be made to the FDA and EMA by the end of next month.
- Alirocumab is a PCSK9 inhibitor that will compete with Amgen's (AMGN +0.2%) evolocumab for supremacy in what is expected to be a $10B post-statin market. Amgen filed its BLA in August, but Regeneron and Sanofi bought an FDA voucher for $67.5M a few months ago that will cut the FDA's review time from 10 months to six, meaning that the projected approval time for both drugs will be about the same (June).
- Amgen filed a patent infringement lawsuit against the two firms last month.
- Previously: Amgen sues Sanofi and Regeneron
- Previously: FDA OK with Amgen's BLA for cholesterol-lowering drug
- Previously: Biotechs to use priority review voucher for cholesterol-lowering drug candidate
Tue, Nov. 18, 4:37 PM
- In a scientific session at the American Heart Association meeting in Chicago, Dr. John Kastelein, professor of medicine, University of Amsterdam, presented data from a retrospective analysis that demonstrated a significant reduction in Major Adverse Cardiovascular Events (MACE) in patients with homozygous and heterozygous familial hypercholesterolemia (FH) treated with Kynamro (mipomersen sodium) for a mean period of two years compared to two years prior to therapy.
- MACE was identified in 146 patients (62%) in the two years prior to treatment with Kynamro compared to 12 (9%) in the two years on treatment. MACE is defined as myocardial infarction, stroke, unstable angina and revascularization procedures.
- The significant reduction in MACE coincided with absolute mean reductions in LDL cholesterol levels (-49 to -113 mg/dL) reported in the Phase 3 FH clinical trials.
- Kynamro is approved in the U.S. to reduce LDL-cholesterol, apoB, total cholesterol and non-HDL cholesterol as an adjunct to lipid lowering medication and diet.
- Mipomersen sodium was developed by Isis Pharmaceuticals (NASDAQ:ISIS) and is being commercialized by Sanofi's (NYSE:SNY) (OTCQB:SNYNF) Genzyme.
Tue, Nov. 18, 9:32 AM
- The Japanese Ministry of Health, Labour and Welfare approves Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NYSE:SNY) (OTCQB:SNYNF) Eylea (aflibercept) for the treatment of diabetic macular edema.
- Eylea was previously cleared for the treatment of neovascular age-related macular degeneration, macular edema secondary to central retinal vein occlusion and myopic choroidal neovascularization.
Mon, Nov. 17, 7:31 AM
- In a poster session at the American Society of Nephrology Kidney Week 2014, Amicus Therapeutics (NASDAQ:FOLD) presented additional data from its 60-patient Phase 3 clinical trial (Study 012) evaluating the safety and efficacy of its small molecule chaperone migalastat HCl as monotherapy for patients with Fabry disease.
- Patients who switched from enzyme replacement therapy (ERT), Fabrazyme (NYSE:SNY) and Replagal (NASDAQ:SHPG), to migalstat showed a statistically significant improvement from baseline in left ventricular mass index (LVMI), a measure of cardiac hypertrophy (increase in the size of the heart) that is associated with an increased risk of cardiac events in Fabry patients. Cardiac disease is a major cause of morbidity and mortality in this population.
- Migalstat baseline mean LVMI (g/m2) was 95.3 with a change of -6.6 to month 18. ERT baseline mean was 92.9 with a change of -2.0 at month 18.
- Migalstat also demonstrated a favorable outcome in a composite endpoint of Fabry-associated clinical events which are defined as a set of morbidities (worsening) in a Fabry patient's renal, cardiac and cerebrovascular status.
- The company expects to have a pre-submission meeting with European regulators this quarter and discussions with the FDA in early 2015.
- Shares are up 14% premarket on increased volume.
Mon, Nov. 17, 7:19 AM
- GCVRZ is up 135% to $1.20 in early premarket action after the FDA approved Lemtrada late on Friday. The deadline for a $1 payment with FDA approval has passed, so the next milestone would be for $2 if the drug exceeds $400M in worldwide sales over a four-quarter period.
- The question: Is GCVRZ a better buy at $1.20 with approval in hand than at $0.50 without yet having approval?
- GCVRZ forum
- Previously: Genzyme's Lemtrada approved by the FDA
- SNY -0.2% premarket
Fri, Nov. 14, 9:47 PM
- Lemtrada was originally rejected by the FDA at the end of last year, but the Sanofi (NYSE:SNY) subsidiary resubmitted the application several months ago. With the FDA's action today, the U.S. joins pretty much the entirety of the rest of the globe in approving Lemtrada for treating relapsing forms of multiple sclerosis.
- Source: Press Release
- The contingent value rights on the drug (NASDAQ:GCVRZ) were trading at nearly $2 each before the FDA's rejection last year and closed today's session at $0.52. Monday should be interesting.
- GCVRZ Forum
Tue, Nov. 11, 7:44 AM
- Dupilumab, a fully-human monoclonal antibody being co-developed by Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN), showed showed positive results in a 776-patient Phase 2b dose-ranging clinical trial in adults with moderate-to-severe uncontrolled asthma.
- The three highest doses of dupilumab in combination with standard-of-care therapy met the primary endpoint of a statistically significant improvement from baseline in forced expiratory volume over one second (FEV1) at week 12 in patients with high blood eosinophils (>= 300 cells/microliter) compared to placebo in combination with standard-of-care therapy. Also, two doses of dupilumab (200 mg every other week and 300 mg every other week) showed a statistically significant improvement in mean percent change in FEV1 and a reduction in severe exacerbations, both in the high eosinophils group and the overall study population.
- Dupilumab blocks IL-4 and IL-13, two cytokines required by the Th2 immune response. Some researchers believed that targeting the Th2 pathway would limit the benefit in asthmatics with high eosinophils, but this study demonstrated that it could be effective. Final results from the trial will be presented at a future medical conference.
- Sanofi plans to proceed to Phase 3 development.
- Asthma-related tickers: (NYSE:GSK) (NYSE:TEVA) (NYSE:AZN) (OTCQX:RHHBY) (NASDAQ:AMGN) (NYSE:MRK) (NYSE:NVS) (NASDAQ:THRX)
Mon, Nov. 3, 1:06 PM
- The FDA accepts Boehringer Ingelheim's NDA for Spiriva Respimat (tiotropium bromide) for the maintenance treatment of asthma in patients at least 12 years old who remain symptomatic on at least inhaled corticosteroids.
- Spiriva is currently cleared for the maintenance treatment of bronchospasm (HandiHaler) associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.
- The Respimat inhaler provides a pre-measured amount of medicine in a slow moving mist that helps the patient inhale the drug. It is designed to deliver the medication in a way that does not depend on how fast air is breathed in from the inhaler.
- Asthma and COPD-related tickers: (THRX -3%)(GSK -0.3%)(AZN -0.8%)(NVS -1.3%)(REGN +0.6%)(SNY -1.5%)(TEVA +1.5%)(OTCQX:RHHBY -1.3%)
Wed, Oct. 29, 9:15 AM
Wed, Oct. 29, 4:21 AM
- Sanofi (NYSE:SNY) says Christopher Viehbacher has resigned as CEO after its board unanimously decided to remove him.
- Chairman Serge Weinberg will take over as CEO on a temporary basis. SNY will re-split the roles once a permanent replacement is found.
- The move follows widespread speculation. SNY's directors were reportedly upset at being caught off guard by Viehbacher's attempts to sell an $8B drug portfolio. SNY had until now downplayed the speculation, saying Viehbacher's termination was "not on the agenda."
- Investors are likely to be disconcerted by the change. Viehbacher is seen as an investor-friendly shareholder, notwithstanding SNY's poor Q3 earnings yesterday, which saw shares drop 9%.
- Shares are -3.9% in Paris following today's news.
- Source: press release
- Previously: Sanofi downplays speculation over CEO's future
- Previously: Sanofi off premarket on soft diabetes forecast
Tue, Oct. 28, 12:46 PM
Tue, Oct. 28, 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).
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