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Novartis AG (NVS)

  • Wed, Feb. 25, 12:36 PM
    • Citing good progress in obtaining clearances and approvals, GlaxoSmithKline (GSK +0.1%) expects to complete its three-part deal with Novartis (NVS -0.2%) sometime during the first week in March.
    • The transaction, first announced in April of last year, consists of GSK buying NVS's vaccines business, the creation of a consumer healthcare joint venture between the two firms and the sale of GSK's marketed oncology portfolio to NVS, including related R&D and the rights to two AKT inhibitors in development.
    • Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly (April 22, 2014)
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  • Mon, Feb. 23, 3:55 PM
    • The FDA approves Novartis' (NVS +0.3%) Farydak (panobinostat) for the treatment of patients with multiple myeloma (MM), the first histone deacetylase (HDAC) inhibitor cleared for this indication. It is intended for patients who have received two prior standard therapies, including bortezomib (Velcade) and an immunomodulatory agent. Farydak should be used in combination with bortezomib, a chemotherapy agent, and dexamethasone, a corticosteroid anti-inflammatory medicine.
    • In November, the Oncologic Drugs Advisory Committee voted 5 - 2 that the benefits of panobinostat did not outweigh the risks. After the meeting, the company submitted additional data supporting the use of Farydak in MM patients who had received at least two prior standard therapies, including bortezomib and dexamethasone.
    • Multiple myeloma afflicts ~22K Americans each year, with ~50% mortality rate within the first year of diagnosis.
    • Previously: Ad Comm votes against panobinostat (Nov. 6, 2014)
    • Previously: Priority review period for Novartis cancer drug extended (Nov. 25, 2014)
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  • Mon, Feb. 23, 12:42 PM
    • The Federal Trade Commission in the U.S. approves Novartis' (NVS +0.1%) purchase of GlaxoSmithKline's (GSK -0.1%) oncology business for $16B, contingent on the divestment of the BRAF and MEK inhibitors.
    • Previously: Why Glaxo bids adieu to cancer drugs (April 22, 2014)
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  • Thu, Feb. 19, 10:10 AM
    • Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
    • The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
    • Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
    • Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
    • Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
    • Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
    • Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
  • Fri, Feb. 13, 1:24 PM
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  • Thu, Feb. 12, 12:56 PM
    • Johnson & Johnson (JNJ -1.6%) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +15.1%) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
    • Biosimilar-related tickers: (PFE +1.3%)(HSP +0.1%)(AMGN -0.4%)(CHRS +0.2%)(PFNX +14.5%)(NVS -0.2%)
  • Thu, Feb. 5, 8:12 AM
    • GlaxoSmithKline (NYSE:GSK) commences an offering of its entire stake of 4,471,202 shares (7.9%) of Danish biotech GenMab. The company is selling its position because it no longer considers it a core asset since it sold its oncology portfolio to Novartis (NYSE:NVS).
    • The outcome of the divestment should be announced today.
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  • Mon, Feb. 2, 6:46 AM
    • The FDA approves Alcon's (NYSE:NVS) Pazeo (olopatadine hydrochloride ophthalmic solution)  0.7% for the treatment of patients with ocular itching associated with allergic conjunctivitis. Pazeo, administered one drop per day, is effective for 24 hours post dose.
    • It will be available by prescription in the U.S. in March, followed by Latin American and Asian markets through 2017.
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  • Tue, Jan. 27, 7:13 AM
    • Novartis (NYSE:NVS) Q4 results ($M): Revenues: 14,633 (-3.0%); Pharmaceuticals: 7,860 (-5.6%); Alcon: 2,703 (+1.8%); Sandoz: 2,512 (+4.2%); Vaccines: 494 (-24.6%); Consumer Health: 1,064 (+2.9%).
    • COGS: 5,369 (+1.1%); R&D Expense: 2,753 (+2.1%); SG&A Expense: 3,676 (-23.0%); Net Income: 1,487 (-27.7%); EPS: 0.62 (-24.4%); CF Ops: 5,205 (+17.0%); Quick Assets: 13,862 (+50.3%).
    • Gross Profit: 9,504 (-5.4%); COGS: 36.7% (+4.1%); Gross Margin: 64.9% (-0.2%); Operating Profit: 1,172 (-50.6%); Operating Earnings Yield: 8.0% (-49.1%); Net Earnings Yield: 10.2% (-25.5%).
    • Key Product Sales: Gleevec/Glivec: 1,237 (+0.8%), Gilenya: 666 (+26.4%), Lucentis: 588 (-6.7%), Tasigna: 428 (+21.6%), Afinitor/Votubia: 426 (+18.0%), Sandostatin: 416 (0.0%).
    • 2015 Guidance: Group Net Sales Growth: Mid-single digit; Core Group Operating Income Growth: High-single digit; Pharmaceuticals Growth: Mid-single digit; Alcon Growth: Mid-to-high single digit; Sandoz Growth: Mid-single digit.
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  • Tue, Jan. 27, 6:09 AM
    • Novartis (NYSE:NVS): Q4 EPS of $1.21 in-line.
    • Revenue of $14.63B (-2.0% Y/Y) beats by $50M.
    • Shares +1.7% PM.
    • Press Release
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  • Mon, Jan. 26, 5:30 PM
  • Fri, Jan. 23, 4:34 PM
    • The FDA approves Novartis' (NYSE:NVS) Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals ages 10 through 25.
    • This approval, including Pfizer's clearance in October, covers the last remaining uncovered main serogroup of N. meningitidis bacteria that causes meningococcal disease: A, B, C, W and Y.
    • Previously: Pfizer seeks regulatory approval for meningitis vaccine (June 17, 2014)
    • Previously: Novartis submits BLA for vaccine (June 17, 2014)
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  • Fri, Jan. 23, 9:26 AM
    • Array BioPharma (NASDAQ:ARRY) acquires worldwide rights to Novartis' (NYSE:NVS) encorafenib, a BRAF inhibitor currently in Phase 3 development for the treatment of melanoma, contingent on the closing of the Novartis/Glaxo transaction that was announced last April.
    • Under the terms of the agreement, Array will make a de minimus (minimal) payment to Novartis but no milestones or royalties will be paid by either party. Novartis will provide transitional regulatory, clinical development and manufacturing services. Specifically, it will conduct and fund the Phase 3 Columbus trial through the earlier of June 30, 2016 or the completion of the first visit from the last patient. Array will take responsibility for the trial at this point with Novartis reimbursing Array for out-of-pocket costs in addition to half of Array's full-time equivalent (labor) costs associated with completing the trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined period. For all studies transferred to Array, Novartis will reimburse Array under the same guidelines as it will for the Columbus trial.
    • Array agrees to recruit a partner that has experience in global development and commercialization.
    • Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly (April 22, 2014)
  • Fri, Jan. 23, 8:34 AM
    • Incyte (NASDAQ:INCY) earns a $25M milestone payment from Novartis (NYSE:NVS) triggered by the positive opinion from Europe's Committee for Medical Products for Human Use (CHMP) supporting marketing authorization for Jakavi (ruxolitinib) for the treatment of adults with polycythemia vera.
    • The company will record the amount as contract revenue and expects to receive payment this quarter.
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  • Fri, Jan. 23, 8:16 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supported marketing authorization for Novartis' (NYSE:NVS) Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera, a rare blood cancer. If approved, it will be the first targeted treatment option for these patients.
    • Jakavi is currently approved as a treatment of certain types of myelofibrosis and disease-related splenomegaly (enlarged spleen).
    • A final decision by the European Commission usually takes ~60 days.
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  • Wed, Jan. 21, 12:47 PM
    • As expected, the FDA approves Novartis' (NVS -3%) Cosentyx (secukinumab) for the treatment of adult patients with moderate-to-severe plaque psoriasis. The FDA advisory committee that reviewed the NDA voted unanimously in favor of approval in October.
    • Previously: Ad Comm backs approval of secukinumab (Oct. 21, 2014)
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Company Description
Novartis AG is engaged in the research, development, manufacturing and marketing of healthcare products and pharmaceuticals.