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Update: Sanofi Wins EC Marketing Authorization For Cerdelga
- Sanofi announced Thursday it received EC marketing authorization for Cerdelga capsules, a first line oral therapy for certain adults living with Gaucher disease type 1.
- I reiterate my bullish thesis on Sanofi.
- As expected, Sanofi continues to improve its prospects amid the patent cliff.
Despite Myriad Of Issues, Sanofi Might Be A Good Buy
- The stock is down more than 20%.
- Diabetes franchise seems to be in trouble.
- The CEO was fired.
Sanofi Faces Serious Competitive Challenges: Is It Time To Buy Or Sell?
- Sanofi is trading below record highs.
- I believe it's difficult to determine the margin of safety at current price levels, as a myriad of factors could restrict Sanofi's growth (e.g., the patent cliff).
- A conservative options strategy mitigates these risks, while enhancing Sanofi's current yield.
Sanofi Rights - Will A Seeking Alpha Post And Strategy Work?
- Would you buy something for $0.82 for the right to receive more than $2 in 60 days?
- A Seeking Alpha message board post, if doable, could make GCVRZ a double, at worst.
- A deal, if possible, would benefit all GCVRZ stakeholders.
- Sanofi would be the only loser, at least with respect to the first, one-time cash outlay.
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 • Aug. 7, 2014
- 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.
Today, 7:31 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) announced that the FDA has accepted under priority review the Biologics License Application (BLA) for Praluent (alirocumab) for the treatment of hypercholesterolemia.
- Priority review status shortens the review time to six months so the PDUFA date is July 24.
- The European Medicines Agency accepted the companies' Marketing Authorization Application (MAA) several weeks ago.
- Alirocumab is an investigational monoclonal antibody targeting proprotein subtilisin/kexin type 9 (PCSK9). It will be competing with Amgen's (NASDAQ:AMGN) evolocumab for supremacy in the post-statin anti-cholesterol market. The PDUFA date for the FDA's review of evolocumab is August 27.
- Previously: European regulator accepts Regeneron/Sanofi application for cholesterol-lowering med (Jan. 12)
- Previously: FDA OK with Amgen's BLA for cholesterol-lowering drug (Nov. 10, 2014)
Thu, Jan. 22, 9:21 AM
- Thinly-traded nano cap Minerva Neurosciences (NASDAQ:NERV) is up 20% premarket (volume unknown) in response to its report of positive results from a Phase 1 trial assessing MIN-202 for the treatment on insomnia. Trial subjects with co-morbid insomnia related to major depressive disorder (MDD) experienced significant improvements in sleep onset and duration.
- The Phase 1b portion was a double-blind, placebo-controlled, randomized, four-way crossover, single dose trial involved 20 male and female patients with MDD and insomnia. The primary endpoint was latency to persistent sleep (LPS). Preliminary results showed a statistically significant effect on LPS in all three doses tested (10 mg, 20 mg and 40 mg) and prolonged sleep duration of ~45 minutes.
- MIN-202 is an orexin-2 antagonist. Its value proposition is improved safety, better restoration of sleep architecture and improved continuity compared to GABA-mimetics like Ambien (NYSE:SNY).
- MIN-202 is being developed in collaboration with Janssen Pharmaceutica NV.
Thu, Jan. 22, 7:14 AM
- The European Commission clears Genzyme's (NYSE:SNY) Cerdelga (eliglustat) for the long-term treatment of patients with Gaucher disease type 1 who are CYP2D6 poor metabolizers, intermediate metabolizers or extensive metabolizers.
- Eliglustat is a novel orally available glucosylceramide analog. It partially inhibits the enzyme glucosylceramide synthase which reduces the production of glucosylceramide, the substance that builds up in the cells and tissues of Gaucher patients.
- The FDA approved Cerdelga in August.
- Previously: FDA approves new drug for Gaucher's disease (Aug. 19, 2014)
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Mon, Jan. 12, 7:37 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) announce that the European Medicines Agency (EMA) accepts for review the Marketing Authorization Application (MAA) for the PCSK9 inhibitor Praluent (alirocumab) for the treatment of patients with hypercholesterolemia.
- Praluent is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor that represents the next generation of cholesterol-lowering medicines beyond statins.
- The BLA for Praluent was submitted to the FDA last quarter. The firms seek approval under the Priority Review process.
- Previously: Biotechs to use priority review voucher for cholesterol-lowering drug candidate (July 30, 2014)
Fri, Jan. 9, 7:31 AM
- Sanofi (NYSE:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN) announce that two Phase 3 clinical trials evaluating alirocumab dosed once every four weeks for the treatment of hypercholesterolemia met their primary efficacy endpoints.
- The first study, Odyssey Choice I, evaluated the safety and efficacy of 300 mg alirocumab compared to placebo in 803 patients with hypercholesterolemia at moderate-to-high cardiovascular risk (CV). More than two thirds of the subjects also received statin therapy.
- The second study, Odyssey Choice II, evaluated the safety and efficacy of 150 mg alirocumab in 233 patients with hypercholesterolemia with high CV risk and/or a history of intolerance to two or more statins. No subjects received statin therapy.
- Both trials met their primary efficacy endpoint of a reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24 versus placebo. The results were comparable to previous studies evaluating a dosing regimen of once every two weeks of alirocumab.
- Alirocumab is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9).
- The data will be presented at a future medical conference.
Thu, Jan. 8, 8:08 AM
- MannKind (NASDAQ:MNKD) earns a $50M milestone payment from partner Sanofi (NYSE:SNY) (OTCQB:SNYNF) for the achievement of Afrezza-related manufacturing milestones.
- It is eligible to receive up to $725M in further development, regulatory and sales milestones as well as a portion of the profits on sales of Afrezza.
Dec. 12, 2014, 10:26 AM
- The FDA approves Sanofi (SNY -0.4%) (OTCQB:SNYNF) division Sanofi Pasteur's supplemental BLA for its Fluzone Intradermal Quadrivalent influenza vaccine. The new product helps protect adult patients (ages 18 - 64) from four strains of influenza virus which is an improvement over the trivalent version that has been available for three years.
Dec. 5, 2014, 8:12 AM
- In a wrongful termination lawsuit, paralegal Diane Ponte claims that ex-employer Sanofi (NYSE:SNY) (OTCQB:SNYNF) paid $34M in kickbacks to boost diabetes drug sales. She says former CEO Chris Viehbacher was in on the scheme.
- Unsurprisingly, Mr. Viehbacher and Sanofi dispute her allegations. In an e-mail statement he says, "The allegations contained in this wrongful termination lawsuit are entirely baseless and are categorically false." Sanofi echoes his sentiment by stating, "Diane Ponte is a disgruntled former employee who is opportunistically attacking our company. The employment law allegations are without merit and Sanofi will vigorously defend the suit. We take this matter very seriously and will protect our company and our reputation."
- Conspicuous by its absence in the company's statement is a reference to the alleged kickbacks.
- Ms. Ponte says Sanofi management retaliated against her after she reported the fraud to her superiors.
Dec. 2, 2014, 9:32 AM
- The FDA, under priority review, approves the use of Sanofi's (NYSE:SNY) (OTCQB:SNYNF) Priftin (rifapentine) for the treatment of latent tuberculosis infection (LTBI) in patients at least two years old when used in combination with isoniazid.
- Priftin is only available in the U.S. It was approved in 1998, in combination with one or more antituberculosis drugs, for the treatment of active pulmonary TB caused by Mycobacterium turberculosis.
- The company is exploring regulatory approval in other markets.
Dec. 1, 2014, 7:41 AM
- Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Pozen (NASDAQ:POZN) "mutually agree" to terminate their commercialization agreement for PA8140 and PA32540 effective November 29, 2014. All rights to the products will revert back to Pozen at that time.
- No specific reason (s) are disclosed explaining the move although Pozen will host a webcast this morning at 8:30 am ET to discuss the issue.
- Henceforward, the two products will be referred to as Yosprala 81/40 (enteric-coated aspirin 81 mg/immediate release omeprazole 40 mg) and Yosprala 325/40 (enteric-coated aspirin 325 mg/immediate release omeprazole 40 mg).
- The PDUFA date is December 30, 2014 for the FDA's review of Pozen's NDA resubmission. The company received a Complete Response Letter (CRL) on April 28, 2014 related to deficiencies noted during an on-site inspection of an ingredient maker.
- Pozen President & CEO Dr. John Plachetka says, Our goal at Pozen continues to be to maximize shareholder return. Management and the BOD are taking this opportunity to evaluate all strategic options for Yosprala and Pozen. With respect to how well Yosprala may perform in the marketplace, we believe that the clinical profile of the drug, as described in the current FDA-proposed package insert, will meet or exceed the assumptions we made when we started our development and evaluated the commercial potential for this product."
- POZN shares are off 10% premarket on light volume.
- Previously: Pozen soars on Sanofi deal
- Previously: Pozen receives a Complete Response Letter
- Previously: Pozen resubmits NDA
- Previously: PDUFA date set for PA8140/PA32540
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 24, 2014, 8:02 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
- The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
- Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
- COPD-related tickers: (NYSE:GSK) (NYSE:NVS) (NASDAQ:THRX) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Nov. 21, 2014, 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)
Nov. 21, 2014, 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)
Nov. 20, 2014, 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.
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