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Novartis AG (NVS)

  • 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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  • Mon, Jan. 19, 5:11 PM
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  • Thu, Jan. 15, 8:40 AM
    • "Words fail me," says Swatch (OTCPK:SWGAY) CEO Nick Hayek. "Today's SNB action is a tsunami; for the export industry and for tourism, and finally for the entire country." Swatch is lower by 15.75% in European action.
    • Previously: Swiss shares crater after SNB abandons cap on euro (Jan. 15)
    • A sampling of others: Cement maker Holcim (OTCPK:HCMLY) is down 11.2%, Novartis (NYSE:NVS) is down 9%, Roche (OTCQX:RHHBY) is down 7.9%, Credit Suisse (NYSE:CS) is down 11.7%, and UBS (NYSE:OUBS) is down 10.8%.
    • The good news for ADR players is that's all action in Switzerland. Thanks to the franc's now 13.5% gain, the ADRs trading in the U.S. are likely all to be higher.
  • Thu, Jan. 15, 8:35 AM
    • Swiss-based Novartis (NYSE:NVS) jumps 5% premarket in response to the upsurge in the value of the Swiss franc versus the euro. The franc rose 30% after the Swiss National Bank announced that it would remove the three-year old cap of 1.20 francs/euro.
    • Previously: Swiss shares crater after SNB abandons cap on euro (Jan. 15)
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  • Thu, Jan. 15, 7:22 AM
    • In an effort to increase its focus on developing new drugs, privately-held Boehringer Ingelheim says that it is considering the sale of Roxane Labs, its U.S.-based generics unit. The company believes it makes more sense for a generics specialist to own the 1,300-employee business.
    • The generics industry is fiercely competitive as the number of blockbuster drugs coming off patent has declined from its peak in 2012. The top players are (NYSE:TEVA), Sandoz (NYSE:NVS) and Actavis (NYSE:ACT).
    • According to Bloomberg, Roxane could fetch as much as $2.4B. Morgan Stanley is advising.
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  • Wed, Jan. 14, 12:02 PM
    • Novartis (NVS +0.4%) Institutes for BioMedical Research initiates a Phase 1 trial of LOP628 which utilizes ImmunoGen's (IMGN +4.3%) antibody-drug conjugate technology. Under the terms of their 2010 Multi-Target Agreement, this triggers a $5M milestone payment to ImmunoGen.
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  • 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.
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Company Description
Novartis AG is engaged in the research, development, manufacturing and marketing of healthcare products and pharmaceuticals.