Today - Friday, February 12, 2016
- Intercept Pharmaceuticals (ICPT +21.9%) jumps on modest volume in apparent response to yet another rumor of a possible sale. In December, shares spiked on the rumor that Shire plc (SHPG +4.3%) was interested, but it took out Baxalta instead.
- Its lead product candidate is obeticholic acid (OCA), under development for the treatment of primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis and biliary atresia.
- The supposed allure for potential suitors is NASH, a blockbuster opportunity for the first mover. OCA flunked a Japan-based Phase 2 study in NASH, however. The FDA's action date for its review of the company's NDA for PBC is February 29.
- Previously: Intercept Pharma's NASH candidate flunks mid-stage study; shares off 15% premarket (Oct. 28, 2015)
- Previously: Intercept Pharma's obeticholic acid NDA for PBC gets Priority Review; PDUFA date is February 29 (Aug. 31, 2015)
- In its first pay-for-delay decision, the U.K.'s Competition and Markets Authority (CMA) dings GlaxoSmithKline (GSK +0.7%) for ₤37.6M ($54.4M) for its activities to delay generic competition to its antidepressant Seroxat (paroxetine) during the period 2001 - 2004.
- According to the Authority, the company paid more than ₤50M to certain firms to delay the launch of their versions, thereby depriving the National Health Service of significantly better pricing. When generics finally hit the market at the end of 2003, prices were 70% below branded Seroxat.
- Despite claims that it did nothing wrong, the company has agreed to the settlement in order to avoid costly litigation.
- The CMA also fined Generics UK (now part of Mylan (MYL -1%)) and its former parent Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) ₤5.8M and Actavis (AGN +0.1%) ₤1.5M as the successor to Alpharma.
- Noted biotech investor Dr. Philip Frost's OPKO Health (OPK -1.7%) acquires a 6.3% interest in Xenetic Biosciences (OTCQB:XBIO +13.6%), a developer of next-generation biologics and cancer-focused therapeutics.
- Xenetic's product candidates include ErepoXen for the treatment of anemia, OncoHist for certain blood cancers, PulmoXen for cystic fibrosis and a Factor VIII for hemophilia (with Baxalta).
- Relypsa (NASDAQ:RLYP) is up 8% premarket on increased volume in response to the news that the U.S. Government's Centers for Medicare & Medicaid Services (CMS) has added Veltassa (patiromer) to its 2016 Formulary Reference File. Inclusion in the file means that the drug may be included in Part D formularies. In other words, it can now be reimbursed.
- Veltassa, Relypsa's sole product, was approved by the FDA in October for the treatment of hyperkalemia (abnormally high levels of potassium in the blood).
- Previously: FDA approves Relypsa's Veltassa; shares +2.2% (Oct. 21, 2015)
- ConforMIS (CFMS) Q4 results: Revenues: $19.1M (+34.5%); SG&A: $21.9M (+25.1%); Operating Loss: ($14.8M) (-23.3%); Net Loss: ($15M) (-24.0%); Loss Per Share: ($0.37) (+86.9%).
- FY2015 results: Revenues: $66.9M (+38.8%);SG&A: $80.4M (+27.6%); Operating Loss: ($56M) (-23.3%); Net Loss: ($57.2M) (-25.2%); Loss Per Share: ($2.60) (+75.9%); Quick Assets: $117.2M (+209.2%).
- 2016 Guidance: Total Revenue: $84M - 87M, Product Revenue: $83M - 86M, Royalty Revenue: ~$0.8M.
- NuVasive (NUVA) Q4 results: Revenues: $215.3M (+5.4%); R&D Expense: $8.6M (-8.5%); SG&A: $121.7M (+0.7%); Net Income: $11.5M (+53.3%); EPS: $0.22 (+46.7%); Non-GAAP EPS: $0.35 (+34.6%).
- FY2015 results: Revenues: $811.1M (+6.4%); R&D Expense: $35.9M (-5.5%); SG&A: $464.5M (-0.8%); Net Income: $66.3M (+497.0%); EPS: $1.26 (+450.0%); Non-GAAP EPS: $1.31 (+95.5%); Quick Assets: $357.8M (-1.4%).
- 2016 Guidance: Revenue: ~$923M; GAAP EPS: ~$1.02; Non-GAAP EPS: ~$1.48.
- A 90-subject study assessing Masimo's (NASDAQ:MASI) rainbow Acoustic Monitoring (RAM) and SedLine brain function monitoring as additional monitoring parameters during planned sedation demonstrated fewer alarm events compared to standard protocols. The two-part study was just published in the journal Anesthesia & Analgesia.
- Data were collected from adults patients under moderate sedation undergoing gastroenterology or interventional radiology procedures. They were monitored under standard protocols [elctrocardiography, blood pressure, pulse oximetry, capnography (CO2)] in addition to RAM and SedLine. Alarm events were defined as desaturation (SpO2 <92%), acoustic respiration rate (<eight breaths per minute) and diastolic blood pressure (<50).
- There were 55% fewer alarm events in patients monitored with RAM and SedLine compared to those monitored under standard protocols. In addition, true positive rates for CO2 for RAM compared to Covidien's Capnostream monitor were 78% and 30%, respectively. Conversely, the false positive rates were 22% and 70%, respectively.
- Studies into the effectiveness of advanced monitoring with RAM and SedLine are continuing.
- Neurocrine Biosciences (NBIX +5%) Q4 results: Revenues: $0; R&D Expense: $21.8M (+40.6%); SG&A: $8.9M (+78.0%); Operating Loss: ($30.7M) (-49.8%); Net Loss: ($29.3M) (-51.0%); Loss Per Share: ($0.34) (-30.8%).
- FY2015 results: Revenues: $19.8M; R&D Expense: $81.5M (+75.6%); SG&A: $32.5M (+80.6%); Operating Loss: ($94.2M) (-46.3%); Net Loss: ($88.9M) (-46.9%); Loss Per Share: ($1.05) (-29.6%); Quick Assets: $379.2M (+95.7%).
- 2016 Guidance: Revenues: $15M; Cash burn: ~$135M - 145M; Expenses: $185M - 195M.
- Health insurer Anthem (NYSE:ANTM) establishes coverage of Novocure's (NASDAQ:NVCR) Optune for the treatment of newly diagnosed glioblastoma. Anthem, covering 38.5M lives, is the fourth commercial payer to cover the use of the product.
- Optune is a non-invasive device that creates alternating "wave-like" electric fields called Tumor Treating Fields (TTFields). It delivers its therapy to brain tumors through four transducer arrays placed on the scalp.
- Shares are up 3% premarket but only on 200 shares.
- DENTSPLY (XRAY -2.1%) Q4 results: Revenues: $671.1M (-6.7%); SG&A: $267.8M (-5.5%); Operating Income: $93.1M (-9.9%); Net Income: $58.6M (-30.8%); EPS: $0.41 (-30.5%); Non-GAAP EPS: $0.65 (+8.3%).
- FY2015 results: Revenues: $2,674.3M (-8.5%); SG&A: $1,077.3M (-5.8%); Operating Income: $375.2M (-15.8%); Net Income: $251.2M (-22.2%); EPS: $1.76 (-21.4%); Non-GAAP EPS: $2.62 (+4.8%); Quick Assets: $284.6M (+87.7%).
- No guidance given.
- LifePoint Hospitals (LPNT -5.1%) Q4 results: Revenues: $1,370.7M (+8.5%); Salaries and benefits: $652.7M (+6.6%); Supplies: $218.4M (+9.7%); Other Operating Expense: $330.9M (+10.3%); Net Income: $53M (+136.6%); EPS: $1.16 (+141.7%); Non-GAAP EPS: $1.11 (+2.8%).
- FY2015 results: Revenues: $5,214.3M (+16.3%); Salaries and benefits: $2,496.9M (+17.0%); Supplies: $815M (+16.6%); Other Operating Expense: $1,246.4M (+14.6%); Net Income: $181.9M (+44.3%); EPS: $3.95 (+46.8%); Non-GAAP EPS: $4.09 (+18.6%); Quick Assets: $284M (+48.3%).
- 2016 Guidance: Net Revenue: $6.45B - 6.55B; Adjusted EBITDA: $765M - 795M; EPS: $3.65 - 3.91.
- Gilead Sciences (NASDAQ:GILD) initiated with Outperform rating and $120 (37% upside) price target by Oppenheimer.
- CareDx (NASDAQ:CDNA) initiated with Buy rating and $12 (137% upside) price target by Janney Capital.
- Shire plc (NASDAQ:SHPG) initiated with Neutral rating by Guggenheim.
- Ultragenyx Pharmaceutical (NASDAQ:RARE) initiated with Buy rating and $104 (95% upside) price target by H.C. Wainwright.
- Depomed (NASDAQ:DEPO) initiated with Buy rating and $22 (38% upside) price target by UBS.
- ACADIA Pharmaceuticals (NASDAQ:ACAD) initiated with Buy rating and $40 (128% upside) price target by Bank of America.
- Leerink restarts coverage on eight stocks: four Outperforms: Alexion Pharmaceuticals (NASDAQ:ALXN); Regeneron Pharmaceuticals (NASDAQ:REGN); Vertex Pharmaceuticals (NASDAQ:VRTX) and Gilead Sciences (GILD); four Market Performs: Celgene (NASDAQ:CELG); Biogen (NASDAQ:BIIB); Medivation (NASDAQ:MDVN) and Amgen (NASDAQ:AMGN).
- TESARO (NASDAQ:TSRO) initiated with Buy rating by Lake Street.
- AbbVie (NYSE:ABBV) initiated with Outperform rating by William Blair.
- Seattle Genetics (NASDAQ:SGEN) upgraded to Buy with $38 (41% upside) price target by Cantor Fitzgerald.
- Shire plc (SHPG) upgraded to Outperform with price target of $240 (59% upside) by RBC.
- Amedisys (NASDAQ:AMED) upgraded to Outperform with $40 (15% upside) price target by Oppenheimer.
- Smith & Nephew (NYSE:SNN) downgraded to Neutral from Buy by UBS. Price target lowered to 1,100p (4% upside) from 1,250p.
- Quidel (NASDAQ:QDEL) downgraded to Hold from Buy by Canaccord. Price target lowered to $18 (18% upside) from $22.
- BioCryst Pharmaceuticals (NASDAQ:BCRX) downgraded Neutral from Overweight by JP Morgan. Price target lowered to $5 (201% upside) from $16.
- DaVita HealthCare Partners (DVA -1.7%) Q4 results: Revenues: $3,533.6M (+6.2%); SG&A: $408.9M (+14.9%); Operating Income: $244.9M (-45.8%); Net Loss: ($6M) (-102.9%); Loss Per Share: ($0.03) (-103.1%); Non-GAAP EPS: $1.01 (+5.2%).
- FY2015 results: Revenues: $13,781.8M (+7.7%); SG&A: $1,452.1M (+15.1%); Operating Income: $1,170.7M (-35.5%); Net Income: $269.7M (-62.7%); EPS: $1.25 (-62.5%); Non-GAAP EPS: $3.83 (+5.2%); Quick Assets: $1,907.2M (46.4%).
- 2016 Guidance: Consolidated Operating Income: $1.800B - 1.950B; Operating Income for Kidney Care: $1.625B - 1.725B; Operating Income for HCP: $175M - 225M; Consolidated Operating Cash Flows: $1.550B - 1.750B.
- The first case of Zika has been identified in Alabama, marking the virus' appearance in 20 U.S. states and Washington, D.C.
- Zika is transmitted through the bites of Aedes mosquitoes, but could also be passed through sexual contact or blood transfusion.
- Besides potential birth defects, the CDC has confirmed that two U.S. women (who recently contracted the disease while traveling abroad) miscarried after returning home, and the virus was found in their placentas.
Thursday, February 11, 2016
- In a regulatory filing, DaVita Healthcare Partners (NYSE:DVA) discloses that it has received a Civil Investigative Demand (CID) from the U.S. Attorney's Office for the Northern District of Texas regarding a False Claims Act investigation into allegations that it submitted false claims to the government for prescription drug reimbursement dating back to January 1, 2006. The company intends to cooperate fully with the inquiry.
- Previously: DaVita unit subject to False Claims Act inquiry (Nov. 18, 2015)
- Previously: DaVita receives subpoenas from HHS (Feb. 12, 2015)
- Previously: DaVita pays $400M to settle whistleblower suit (Oct. 23, 2014)
- Zimmer Biomet Holdings (NYSE:ZBH) receives 510(k) clearance for its Unite3D Bridge Fixation System, used to provide stability in foot and ankle joint fusion surgery. The device, which features the company's proprietary OsseoTi porous metal technology, is made with a 3D printer which produces a design that mimics the architecture of cancellous (spongy) bone. It also features an osteoconductive matrix that promotes biological integration.
- Alnylam (NASDAQ:ALNY) Q4 results ($M): Net Revenues From Collaborators: 7.6 (-68.3%); Operating Expenses: 100.1 (+43.6%); Quick Assets: 1,281.0 (+45.3%).
- Net Loss: (90.7) (-323.8%); Loss Per Share: (1.07) (-282.1%): Non-GAAP Loss Per Share: (1.07) (-282,1%).
- Pipeline up to eight programs. Patisiran regulatory submission on track for 2017. At least 10 major clinical data readouts on tap for this year.
- 2016 Guidance: Cash balance greater than $850M.
- Shares are flat after hours on modest volume.
- Arcadia Biosciences (NASDAQ:RKDA) President & CEO Eric Rey will step down from his executive and board member roles in order to devote himself to a full recovery from a coronary stent procedure. He will serve as as consultant during the search for and orientation of his successor. VP of business development Roger Salameh will serve as interim CEO until a permanent replacement for Mr. Rey is appointed.
- U.K. finance blogger Betaville reports hearing i-bank Moelis is "trying to broker a deal" between WebMD (WBMD +4.5%) and drugstore giant Walgreens Boots. Walgreen is said to have "already submitted an indicative offer."
- The FT reported in January WebMD is exploring a sale of all or part of its business. However, soon afterwards, the company stated it's "not currently in any negotiations to be acquired."
- Q4 results arrive on the afternoon of Feb. 23.
- IPO AveXis (NASDAQ:AVXS) is faring a bit better than fellow IPO Proteostasis Therapeutics (NASDAQ:PTI) although down 13% from its $20 offer price on light turnover of 760K shares.
- AveXis priced its debut at the midpoint of its proposed range of $19 - 21 so, all things considered, not too bad for a bad day for an IPO. Proteostasis is changing hands at more than 52% below its original midpoint of $12 - 14.
- Previously: AveXis on deck for IPO (Feb. 8)
- Embattled upstart blood-testing firm Theranos received a warning letter last month from Walgreens Boots Alliance (WBA -1.9%) that it may end their relationship unless it can quickly fix the problems at its Newark, CA laboratory. Apparently, Theranos' largest customer has given it until the end of the month to resolve the issues cited in a government audit.
- Theranos is running the tests normally performed at the Newark site at its Arizona facility. Its director, however, does not have a medical degree nor is pathology board-certified. The company says it has hired a new director who has the appropriate credentials, but has not publicly named the person.
- If WBA pulls the plug, Theranos will struggle to recover, say analysts. If this happens, it would a stunning collapse for the company and founder Elizabeth Holmes, who was the world's youngest female self-made billionaire based on her stake in the firm that was valued as high as $9B.
- Previously: Walgreens halts openings of new Theranos centers (Oct. 24, 2015)
- Previously: Theranos' $350M Safeway deal on the rocks (Nov. 11, 2015)
- Previously: Theranos in more hot water (Jan. 27)
- IPO Proteostasis Therapeutics (NASDAQ:PTI) is getting some rude treatment in its first day of trading. Shares are down 25% from the discounted price of $8 on turnover of 1.4M. The debut price was cut 38% from the (midpoint) of original expected range of $12 - 14.
- Previously: Proteostasis prices IPO well below range at $8; trading commences today (Feb. 11)
- Vanda Pharmaceuticals (VNDA -4.9%) Q4 results: Revenues: $31.8M (+106.5%); R&D Expense: $8.7M (+81.3%); SG&A: $28.9M (+67.1%); Operating Loss: ($14.9M) (-121.4%); Net Loss: ($14.8M) (-121.2%); Loss Per Share: ($0.35) (-119.8%); Non-GAAP Loss Per Share: ($0.23) (+36.1%).
- FY2015 results: Revenues: $109.9M (+118.9%); R&D Expense: $29.1M (+51.6%); SG&A: $84.5M (-0.1%); Operating Loss: ($40.2M) (+300.0%); Net Loss: ($39.9M) (-297.5%); Loss Per Share: ($0.94) (-270.9%); Non-GAAP Loss Per Share: ($0.45) (+80.4%); Quick Assets: $143.2M (+10.3%).
- 2016 Guidance: Net product sales from both HETLIOZ and Fanapt: $143M - 153M; HETLIOZ® net product sales: $73M - 78M; Non-GAAP Operating expenses: $125M - 135M; 2016 year end cash: $123M - 143M.
- Thinly traded nano cap NanoViricides (NNVC +15.5%) is up on increased volume in early trading in response to its announcement of an agreement with the University of Pittsburgh Medical Center's Eye Center's Ophthalmic Microbiology Laboratory for the testing of its drug candidates in standard animal models of ocular virus infections.
- The tests will be performed to assess their efficacy and potency as anti-viral agents in ocular viral infections. If successful, the company plans to file an Investigational New Application (IND) with the FDA for clearance to start clinical trials.
- The firm's nanoviricide drug candidates are designed to specifically attack virus particles and dismantle them. A nanoviricide is created by attaching a virus-binding ligand (derived from the virus's cell surface receptor) to a flexible polymer. Pipeline candidates include drugs for H5N1 bird flu, seasonal influenza, HIV, Epidemic Kerato-Conjunctivitis, hepatitis C, rabies, dengue fever and Ebola.
- Cyanotech (CYAN -1.7%) FQ3 results: Revenues: $7.5M (-22.7%); Operating Expense: $2.8M (-20.0%); Operating Income: $0.3M (-75.0%); Net Loss: ($0.3M) (-160.0%); Loss Per Share: ($0.04) (-150.0%); Quick Assets: $2M (-9.1%).
- No guidance given.
- Update: Shares are down 24% on a 28x surge in volume about one hour before the close.
- Genocea Biosciences (GNCA +1.8%) Q4 results: Revenues: $0.2M (-33.3%); R&D Expense: $6.5M (-25.3%); SG&A: $3.8M (+46.2%); Operating Loss: ($10.1M) (+7.3%); Net Loss: ($10.3M) (+12.0%); Loss Per Share: ($0.37) (+43.9%).
- FY2015 results: Revenues: $0.7M (+133.3%); R&D Expense: $28M (+18.1%); SG&A: $14M (+44.3%); Operating Loss: ($41.4M) (-24.7%); Net Loss: ($42.5M) (-20.4%); Loss Per Share: ($1.74) (+23.3%); Quick Assets: $106.4M (+125.9%).
- No guidance given.
- Invacare (IVC +5.2%) Q4 results: Revenues: $283.3M (-11.0%); SG&A: $78.5M (-11.4%); Net Loss: ($2.9M) (+56.7%); Loss Per Share: ($0.09) (+57.1%); Non-GAAP Loss Per Share: ($0.06) (+50.0%).
- FY2015 results: Revenues: $1,142.3M (-10.1%); SG&A: $319.8M (-16.7%); Net loss: ($26.5M) (+61.5%); Loss Per Share: ($0.82) (+61.9%); Non-GAAP Loss Per Share: ($0.62) (+61.0%); Quick Assets: $60.1M (+54.5%).
- No guidance given.
- Acorda Therapeutics (ACOR -3.5%) Q4 results: Revenues: $130.9M (+11.0%); R&D Expense: $44M (+69.9%); SG&A: $53M (-6.2%); Operating Income: $3.9M (+225.0%); Net Income: $9.2M (+999%); EPS: $0.21 (+999%); Non-GAAP EPS: $0.28 (-39.1%).
- FY2015 results: Revenues: $492.7M (+22.7%); R&D Expense: $149.2M (+103.0%); SG&A: $205.6M (+1.9%); Operating Income: $34M (-6.6%); Net Income: $11.1M (-37.3%); EPS: $0.25 (-40.5%); Non-GAAP EPS: $1.05 (-39.7%); Quick Assets: $353.3M (+14.9%).
- 2016 Guidance: AMPYRA Net Revenue: $475M - 485M; R&D Expense: $165M - 175M; SG&A Expense: $195M - 205M.
- Quintiles Transnational Holdings (Q) Q4 results: Revenues: Revenues: $1,521.7M (+7.8%); SG&A: $244.1M (+8.4%); Operating Income: $178M (+12.0%); Net Income: $104.6M (+18.3%); EPS: $0.85 (+23.2%); Non-GAAP EPS: $0.90 (+26.8%).
- FY2015 results: Revenues: $5,737.6M (+5.1%); SG&A: $921M (+4.4%); Operating Income: $646.6M (+9.5%); Net Income: $387.2M (+8.6%); EPS: $3.08 (+13.2%); Non-GAAP EPS: $3.33 (+23.3%); Quick Assets: $977.2M (+12.7%).
- 2016 Guidance: GAAP Net Income: $432M - 454M; Adjusted Net Income: $454M - 473M; GAAP EPS: $3.52 - 3.70; Adjusted EPS: $3.70 - 3.85; Constant currency service revenue growth: 7.0 - 8.5%.
- Shire plc (NASDAQ:SHPG) Q4 results ($M): Total Revenues: 1,715.7 (+8.9%); Product Sales: 1,623.7 (+8.2%).
- Key Product Sales: Vyvanse: 453.3 (+18.2%); Lialda/Mezavant: 201.4 (+9.0%); Elaprase: 147.1 (+2.7%); Cinryze: 143.3 (+0.6%), Firazyr: 125.2 (+22.9%).
- Net Income: 280.6 (-87.1%); Non-GAAP Net Income: 587.6 (+13.2%); EPS: 0.473 (-87.1%); Earnings per ADS: 0.1419 (-87.1%); Non-GAAP Earnings per ADS: 0.2971 (+12.8%); CF Ops: 761.8 (-70.2%).
- 2016 Guidance: Product Sales Growth: 11 - 14%; Non-GAAP Earnings/ADS Growth: 7 - 10%.
- Shares are up 3% premarket on increased volume.
- The first patient has been enrolled in a Phase 2 clinical trial evaluating Navidea Biopharmaceuticals' (NYSEMKT:NAVB) Lymphoseek (technetium Tc 99m tilmanocept) injection in women with cervical cancer. The study will assess the use of Lymphoseek in sentinel lymph node biopsy during cervical cancer surgery in support of its current label in lymphatic mapping.
- The trial will enroll up to 40 subjects. Each will receive a single dose of Lymphoseek administered around the tumor 1 - 2 hours before surgery. The primary endpoint is the per-patient false negative rate. According to clinicaltrials.gov, the estimated study completion date is August of this year.
- Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor. These have the highest probability of harboring cancer cells.
- Citing the need to reduce operating expenses and conserve cash as U.S. competitors erode JUXTAPID (lomitapide capsules) sales, Aegerion Pharmaceuticals (NASDAQ:AEGR) intends to cut 25% of its workforce by the end of Q2. The company will have ~230 employees after the reduction.
- CEO Mary Szela says, "We believe this action better aligns the company's resources with our current strategy and market opportunity with JUXTAPID and our goal of continuing to grow MYALEPT (metreleptin for injection) sales, supports our objective to create a pipeline of therapies to treat patients with rare diseases and positions us to maximize the value of our assets for our shareholders."
- Teva Pharmaceutical Industries (NYSE:TEVA) Q4 results ($M): Total Revenues: 4,881 (-5.6%); Generic Medicines: 2,257 (-8.6%); Specialty Medicines: 2,114 (-5.8%); MS Specialty: 960 (-14.4%); Other Specialty: 1,154 (+2.9%).
- Key Product Sales: Copaxone: 960 (-14.4%); Treanda: 198 (-12.4%); ProAir: 148 (+23.3%).
- Net Income: 485 (-30.9%); EPS: 0.55 (-31.3%); Non-GAAP EPS: 1.28 (-3.8%); CF Ops: 1,615 (-7.8%).
- Q1 Guidance: Revenues: $4.7B - 4.9B; Non-GAAP EPS: $1.16 - 1.20; CF Ops: $1.2B - 1.3B. Full-year guidance will be released after the close of the Actavis Generics transaction.
- Shares are down 3% premarket on light volume.
- Incyte (NASDAQ:INCY) Q4 results ($M): Total Revenues: 243.9 (+96.7%); Jakafi Sales: 182.0 (+71.7%); Operating Expenses: 169.1 (+14.9%); Quick Assets: 707.8 (+17.9%).
- Net Income: 55.2 (+249.6%); EPS: (+231.8%).
- 2016 Guidance: Jakafi Sales: $800M - 815M.
- Conference call this morning at 10:00 am ET.
- Shares are down 16% premarket on light volume.
- Previously: Incyte bags late-stage development of Jakafi for solid tumors; shares down 10% premarket (Feb. 11)
- Incyte (NASDAQ:INCY) terminates its Phase 3 clinical trial assessing Jakafi (ruxolitinib), in combination with chemo agent capecitabine, for the second-line treatment of advanced or metastatic pancreatic cancer after an interim analysis failed to show sufficient efficacy.
- Based on these data and the interim analysis of the Phase 2 sub-study of Jakafi, in combination with Bayer's (OTCPK:BAYRY) STIVARGA (regorafenib), in patients with metastatic colorectal cancer and high C-reactive protein (CRP), the company will stop all Jakafi studies in solid tumors, including Phase 2 trials in breast and lung cancer. It will also discontinue its dose-finding study of INCB39110 ( a selective JAK1 inhibitor) as first-line treatment for pancreatic cancer.
- Data from all the discontinued trials will be analyzed and shared with the scientific community over the next few months.
- Ongoing studies of Jakafi and selective JAK1 inhibitors in hematology will continue as will those assessing selective JAK1 inhibition in solid tumors based on different hypotheses. These include a series of studies evaluating INCB39110 in combination with Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) and Incyte's epacadostat and INCB50465. A Phase 1/2 trial will also be conducted assessing INCB39110 plus AstraZeneca's (NYSE:AZN) TAGRISSO (osimertinib).
- Jakafi is a JAK1/JAK2 inhibitor cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis.
- Shares are off 10% premarket on light volume.
- Innovus Pharmaceuticals (OTCQB:INNV) acquires Austin, TX-based Beyond Human, LLC for $630K in cash. The privately held firm's flagship product is a natural testosterone booster called Beyond T Human. The company generated ~$1.3M in sales in 2014 and ~$2.2M last year.
- According to Innovus, the transaction will add $3M in gross revenues and over $600K in net profits to its operations, once integrated into its platform.
Wednesday, February 10, 2016
- Psychemedics (NASDAQ:PMD): Q4 EPS of $0.03
- Revenue of $6.13M (-9.3% Y/Y)
- Cepheid (NASDAQ:CPHD) promotes EVP and Chief Operating Officer Warren Kocmond to President & COO. His expanded responsibilities now include Global Commercial Operations in addition to Manufacturing, Engineering, Technical Service and Customer Service. He will continue to report to Chairman and CEO John Bishop.
- Genomic Health (NASDAQ:GHDX) Q4 results ($M): Total Revenues: 74.5 (+7.8%); U.S. Revenues: 63.9 (+8.7%); Operating Expenses: 78.0 (+3.9%).
- Net Loss: (3.2) (+39.0%); Loss Per Share: (0.10) (+50.0%).
- 2016 Guidance: Total Revenues: $320M - 335M; Net Loss: $12M - 18M; Oncotype DX tests delivered: 117.5K - 121K.
- Mylan N.V. (NASDAQ:MYL) acquires Solna, Sweden-based Meda Aktiebolag for $9.9B, including the assumption Meda debt. The cash-and-stock transaction values the Meda equity at $7.2B, with the cash portion at $5.7B.
- The deal will be immediately accretive to Mylan's earnings, adding $0.35 - 0.40 in 2017 and enabling the achievement of non-GAAP EPS of $6.00 a year earlier also in 2017.
- The combined company's 2015 sales were $11.8B with non-GAAP EBITDA of ~$3.8B generated by over 2,000 products sold in more than 165 markets worldwide. Meda's 2015 results were sales of $2.3B and non-GAAP EBITDA of $768M.
- Novartis (NVS +0.5%) inks a pricing deal with Cigna (CI +0.9%) and Aetna (AET +2.5%) for its heart drug Entresto (sacubitril/valsartan) that is based on its ability to reduce the proportion of patients who are admitted to the hospital for heart failure. The performance-based scheme applies to the insurers' commercial business, not Medicare or Medicaid.
- Entresto costs $12.50 per day or $4,560 per year, not the most expensive new drug but higher than expected. The deal specifies a base price and modest rebate that will fluctuate based on the number of hospitalizations and savings to the plan.
- Analysts expect more performance-based drug pricing arrangements going forward since it holds the manufacturer accountable for the product's claimed efficacy. Insurers like the deals because they will save money if the drug's benefits are realized and will pay a premium only in such instances, thereby derisking including the drug in their formularies.
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