Oct. 28, 2014, 7:22 AM
- Novartis (NYSE:NVS) Q3 results ($M): Total Revenue: 14,704 (+2.6%); Pharmaceuticals: 7,925 (+0.4%); Alcon: 2,665 (+5.0%); Sandoz: 2,401 (5.6%); Vaccines: 588 (-1.0%); Consumer Health: 1,125 (+8.3%).
- COGS: 5,096 (+3.8%); R&D Expense: 2,372 (-1.9%); SG&A Expense: 4,227 (+0.0%); Net Income: 3,240 (+43.1%); EPS: 1.37 (+52.2%); CF Ops: 4,011 (-8.4%); Quick Assets: 10,427 (+42.1%).
- Gross Profit: 9,877 (+2.4%); COGS: 34.7% (+1.2%); Gross Margin: 67.2% (-0.2%); Operating Profit: 2,980 (+11.6%); Operating Earnings Yield: 20.3% (+8.8%); Net Earnings Yield: 22.0% (39.5%).
- Product Sales: Gleevec/Glivec: 1,213 (+7.1%); Lucentis: 614 (+5.7%); Gilenya: 653 (+26.1%); Sandostatin: 433 (+8.0%); Afinitor/Votubia: 408 (+21.1%); Tasigna: 391 (+24.1%); Exforge: 365 (+1.7%); Exelon/Exelon Patch: 261 (+3.2%).
- 2014 Guidance: Group net sales growth: low to mid-single digit (unch); core group operating income: mid to high-single digit (unch).
Oct. 28, 2014, 6:12 AM
- Novartis (NYSE:NVS): Q3 EPS of $1.33 beats by $0.04.
- Revenue of $14.7B (+2.5% Y/Y) beats by $360M.
Oct. 27, 2014, 5:30 PM
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Oct. 27, 2014, 6:43 AM
- Novartis (NYSE:NVS) sells its global influenza vaccine business to Australian blood products firm CSL Ltd. for $275M. The transaction, part of Novartis' effort to focus on its most promising assets, concludes the company's overhaul of its units. The deal is expected to close in 2H 2015.
- Earlier this year, GlaxoSmithKline (NYSE:GSK) bought its vaccine business, ex-flu, for $5.25B plus milestones up to $1.8B and royalties.
Oct. 23, 2014, 9:00 AM
- Novartis' (NYSE:NVS) fully human mAb, AIN457 (secukinumab), meets its primary and key secondary endpoints in two Phase 3 clinical trials assessing its safety and efficacy as a treatment for the symptoms of ankylosing spondylitis. The company plans to present the data at an upcoming medical congress.
- Secukinumab neutralizes the action of IL-17A, a protein that stimulates inflammation. Several days ago, an FDA Advisory Committee voted unanimously in favor of approval for the mAb for the treatment of moderate-to-severe plaque psoriasis.
Oct. 21, 2014, 7:32 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee votes unanimously in favor of approving Novartis' (NYSE:NVS) interleukin-17A inhibitor secukinumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. A final decision by the FDA is expected in early 2015.
- Novartis has also submitted its regulatory application with the European Medicines Agency. A decision is expected in late 2014 to early 2015.
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Oct. 19, 2014, 4:19 PM
Oct. 17, 2014, 1:02 PM
- Waltham, MA-based Proteon Therapeutics (PRTO) is set for its IPO of 4.7M shares at $12 - 14.
- The clinical-stage biopharmaceutical firm focuses on the needs of patients with renal and vascular disease. Its lead product is PRT-201, a recombinant elastase, for the prevention of vascular access failure in patients undergoing hemodialysis. The Fast Track and Orphan Drug-designated product candidate may inhibit neointimal hyperplasia, the growth of tissue inside blood vessels that can result in vessel narrowing and reduced blood flow. The company is positioning PRT-201 as a one-time application when a surgeon creates an arteriovenous fistula (AVF) for a dialysis patient, which has a failure rate as high as 70%.
- 2013 operating results ($M): Operating Expenses: 7.1 (-10.9%); Net Loss: (14.0) (-0.7%).
- 1H 2014 operating results ($M): Operating Expenses: 4.4 (+29.9%); Net Loss: (8.8) (-36.5%); Quick Assets: 25.4 (as adjusted: 79.9).
- A Phase 3 trial to assess PRT-201 in radiocephalic AVFs is underway. A second Phase 3 is scheduled to begin in 1H 2015.
- In March, Novartis (NVS +2.3%) walked away from a deal after negotiations on an acquisition price failed.
- ETFs: IBB, BIB, BIS (IPO +1.9%)
Oct. 16, 2014, 11:46 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee meets on Monday, October 20 to review Novartis' (NVS -1.7%) BLA for secukinumab, a human mAb, for the treatment of adults with moderate-to-sever plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Briefing docs
- Psoriasis-related tickers: (JNJ -1%)(DERM -5%)(MRK -2.2%)(CELG -0.9%)(IDRA +6.8%)(HSP +1.1%)(CANF)(AMGN -1.5%)(AZN -1.1%)(PFE -1.3%)
Oct. 15, 2014, 4:13 AM
- The Supreme Court is due to hear oral arguments today over a patent for Teva's (NYSE:TEVA) top-selling multiple sclerosis drug Copaxone, which accounts for 50% of its profit.
- The patent was due to expire in September 2015, although in July 2013, the U.S. Court of Appeals for the Federal Circuit ruled that the patent was invalid. Copaxone has no IP protection at the moment.
- Two consortia are developing generic versions of Copaxone, with one involving Novartis (NYSE:NVS) and Momenta (NASDAQ:MNTA), and the other Mylan (NASDAQ:MYL) and Natco. The companies risk having to pay Teva hundreds of millions of dollars if they introduce Copaxone and then lose in the Supreme Court.
Oct. 7, 2014, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
Oct. 7, 2014, 9:03 AM
- The Novartis Institutes for BioMedical Research (NYSE:NVS) exercises its rights under its Multi-Target Agreement with ImmunoGen (NASDAQ:IMGN) to take three licenses to develop and commercialize anticancer products to three undisclosed targets using IMGN's Ab-drug conjugate technology.
- IMGN will record $25.7M in Q4 revenue as a result. It is eligible to receive up to $199.5M in milestones plus royalties on commercial sales for each license.
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. 6, 2014, 1:00 PM
- Bristol-Myers Squibb (BMY -0.6%) and Novartis (NVS -0.2%) team up in a clinical trial collaboration to evaluate combination therapies as potential treatments for non-small cell lung cancer (NSCLC).
- Novartis will conduct two Phase 1/2 trials focused on NSCLC. One will evaluate the combination of Opdivo (nivolumab) with Zykadia (ceritinib) and the other will investigate Opdivo in combination with INC280, an inhibitor of c-MET receptor tyrosine kinase and EGF816, a third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations.
- Additional details about the partnership are undisclosed.
- Related ticker: (INCY +0.4%)
Oct. 6, 2014, 10:44 AM
- Privately-held Sunnyvale-CA-based Icon Bioscience announces that the last patient has completed treatment in its pivotal Phase 3 clinical trial of IBI-10090. The firm expects to report top-line data this quarter.
- IBI-10090 is a controlled sustained-release formulation of dexamethasone based on the company's Verisome drug delivery platform. It is administered via a single injection into the anterior chamber of the eye immediately following cataract surgery.
- Some eye therapy-related tickers: (NASDAQ:EYEG)(ALIM)(OTCQX:RHHBY +0.5%)(ABT +1.3%)(OHRP -0.3%)(AKRX +1.1%)(OCUL +1.4%)(NVS +0.2%)(AERI +0.7%)(AGN -0.2%)(REGN)(AAVL +0.4%)
Oct. 3, 2014, 7:45 AM
Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers... More
Industry: Drug Manufacturers - Major
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