Saturday, January 31, 2015
- The FDA approves Shire's (NASDAQ:SHPG) Vyvanse (lisdexamfetamine dimesylate) for the treatment of adult patients with binge-eating disorder, a condition characterized by recurrent episodes of compulsive overeating even when the patient does not feel hungry.
- Binge-eating disorder can lead to weight gain and health problems related to obesity, but it is not approved or recommended for weight loss.
- Vyvanse was approved for sale in the U.S. in 2007 for the treatment of attention deficit hyperactivity disorder (ADHD) in patients at least six years old.
- The FDA approves Zogenix's (NASDAQ:ZGNX) Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek, a formulation technology that provides abuse-deterrent features without changing the release properties of hydrocodone.
- BeadTek incorporates pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents.
- The company intends to transition all Zohydro strengths to the BeadTek version in Q2. In H2, it expects to submit the results from its ongoing Human Abuse Liability Studies, which will further characterized the abuse-deterrent properties of the BeadTek formulation, to the FDA.
- Related tickers: (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NYSE:PFE)
Friday, January 30, 2015
- Opko Health (OPK +3.5%) submits an Investigational New Drug Application (IND) to the FDA for clearance to commence a Phase 2a study evaluating its long-acting Orphan Drug-designated coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VII or Factor IX.
- Currently, Factor VIIa therapy is administered intravenously which requires multiple infusions, due to its short half-life, to treat a bleeding episode.
- The longer duration of action of Opko's Factor VIIa-CTP is based on the naturally occurring peptide, C-terminal peptide, of the beta chain of human chorionic gonadotropin (hCG).
- Opko acquired the rights to the product when it bought Prolor Biotech.
- Previously: Opko completes its acquisition of Prolor Biotech (Aug. 29, 2013)
- Related tickers: (BAX +0.4%)(SGMO +0.6%)(ALNY +0.5%)(BIIB +11.4%)(OTCPK:BAYRY -1.4%)
- SurModics (SRDX +0.1%) FQ1 results: Revenues: $14.2M (+2.2%); R&D Expense: $3.6M (-2.7%); SG&A: $3.7M (-5.1%); Operating Income: $5M (+16.3%); Net Income: $3.6M (-0.4%); EPS: $0.27 (+3.8%); Quick Assets: $30.7M (-34.1%); CF Ops: $5.5M (+27.9%).
- FY2015 Guidance: Revenue: $57.0M - 60.0M (unch); GAAP EPS: $0.85 - 0.95; GAAP Cash Flow: $16.5M - 18.0M (unch); CAPEX: $2.2M - 2.5M (unch).
- PerkinElmer (PKI +3.8%) Q4 results: Revenues: $608.4M (+2.8%); COGS: $330.8M (+5.0%); R&D Expense: $31M (-4.9%); SG&A: $216.6M (+53.7%); Operating Income: $30.6M (-67.1%); Net Income: $31.3M (-57.4%); EPS: $0.28 (-56.9%); CF Ops: $96.6M (+40.0%).
- FY2014 results: Revenues: $2,237.2M (+3.7%); COGS: $1,232.6M (+4.3%); R&D Expense: $121.1M (-8.5%); SG&A: $659.3M (+13.3%); Operating Income: $210.7M (-7.5%); Net Income: $161.2M (-7.5%); EPS: $1.42 (-7.8%); Quick Assets: $174.8M (0.9%); CF Ops: $282.3 (+79.6%).
- 2015 Guidance: GAAP EPS: $2.04 - 2.10; Adjusted EPS: $2.58 - 2.64.
10:04 AM| Comment!
- Humira % growth in 2015: mid-teens. Promising work being done on expanded indications.
- Viekira Pak: U.S. launch began in earnest in January. Standard managed care contracting approach used with large payers. More than 40% of covered lives in U.S. have access to V Pak; >20% on an exclusive basis for HCV-1. ~1,100 prescriptions have been written in January - consistent with expectations. Negotiations with foreign governments progressing rapidly. Global sales run rate by end of year: >$3B (exit rate), U.S. will be dominate share. $48M sales booked in December were stocking quantities to prepare for January launch. Mgmt doesn't foresee significant price pressure once Merck enters the market.
- 2015 Guidance: if currency exchange rates stayed the same as they are now, total revenues will be 5% lower. Adjusted gross margin should improve 100 basis points. Operating margin should increase 400 basis points.
- Q1 Guidance: EPS: $0.64 - 0.66.
- (ABBV -2.3%)
- Idexx Laboratories (IDXX -0.9%) Q4 results: Revenues: $352M (-0.6%); COGS: $169.8M (+2.7%); R&D Expense: $24.9M (+10.7%); SG&A: $122.5M (+16.9%); Operating Income: $34.8M (-43.2%); Net Income: $26M (-40.0%); EPS: $0.54 (-34.1%).
- FY2014 results: Revenues: $1,485.8M (+7.9%); COGS: $669.7M (+7.9%); R&D Expense: $98.3M (+11.7%); SG&A: $457.6M (+14.0%); Operating Income: $260.3M (-2.4%); Net Income: $181.9M (-3.1%); EPS: $3.58 (+2.9%); Quick Assets: $322.5M (+15.5%); CF Ops: $235.8M (-4.1%).
- 2015 Guidance: Revenue: $1,640M - 1,660M from $1,690M - 1,710M; EPS: $4.33 - 4.43 from $4.38 - 4.48.
- ImmunoGen (IMGN +0.5%) FQ2 results: Revenues: $48.3M (+60.5%); R&D Expense: $27.6M (+32.1%); G&A: $6.9M (+27.8%); Operating Income: $13.8M (+263.2%); Net Income: $13.6M (+257.9%); EPS: $0.16 (+300.0%); Quick Assets: $106.6M (-25.1%); CF Ops: $34.4M (+59.3%).
- 2015 Guidance: Revenues: $100M - 105M; operating expenses: $160M - 165M; net loss: ($60M - 65M); cash burn: ($55M - 60M); capex: $7M - 9M; quick assets at fiscal year end: $75M - 85M. All items unchanged from FQ1 guidance.
- Pfizer (NYSE:PFE) terminates its development agreement with Repligen (NASDAQ:RGEN) for compounds to treat spinal muscular atrophy, effective April 26. The collaboration was originally signed in late 2012.
- Previously: Repligen gets first milestone payment from Pfizer for SMA program (Sept. 4, 2013)
8:21 AM| Comment!
- AbbVie (NYSE:ABBV) Q4 results ($M): Revenues: 5,452 (+6.7%); COGS: 1,119 (-12.7%); R&D Expense: 907 (+13.7%); SG&A Expense: 3,341 (+130.7%); Other Expense: 500 (+941.7%); Net Income: (810) (-171.8%); EPS: -0.51 (-172.9%).
- Gross Profit: 4,333 (+13.2%); COGS: 20.5% (-18.2%); Gross Margin: 79.5% (+6.1%); Operating Earnings: (415) (-127.0%); Operating Earnings Yield: (7.6%) (-125.3%); Net Earnings Yield: (14.9%) (-167.3%).
- Key Product Sales: Viekira Pak: 48; Humira: 3,363 (-15.1%); AndroGel: 230 (-20.4%); Kaletra: 203 (-11.0%); Synagis: 298 (-5.1%); Synthroid: 186 (-1.6%); Lupron: 207 (-1.0%); Sevoflurane: 120 (-23.1%); Creon: 151 (+31.3%); Dyslipidemia: 104 (+73.3%); Duodopa: 56 (+14.3%).
- 2014 Guidance: EPS: $3.91 - 4.11; Non-GAAP EPS: $4.25 - 4.45.
- Novo Nordisk (NVO +2.1%) Q4 results (DKK): Revenues: 24,585M (+13.3%); Gross Profit: 20,586M (+12.5%); Operating Income: 9,157M (+24.5%); Net Income: 6,529M (+7.9%); EPS: 2.51 (+10.6%).
- FY2014 results (DKK) : Revenues: 88,806M (+6.3%); Gross Profit: 74,244M (+6.9%); Operating Income: 34,492M (+9.5%); Net Income: 26,481M (+5.2%); EPS: 10.07 (+7.7%); Quick Assets: 15,905M (9.9%); CF Ops: 31,962M(+23.2%).
- FY2015 Guidance: (DKK): Sales growth: 6 -9% ; operating income growth: ~10%; net financials: ~5.0B; CAPEX: ~5.0B; FCF: 25B - 31B.
- Intercept Pharmaceuticals (NASDAQ:ICPT) is up 32% premarket on light volume in response to its announcement that the FDA has designated its investigational product obeticholic acid (OCA) a Breakthrough Therapy for the treatment of nonalcoholic steatohepatitis (NASH).
- OCA is a bile acid analogue in development as a treatment for several liver diseases. NASH is the "next big thing" for drug makers after HCV.
- Breakthrough Therapy status enables a shorter approval timeline by involving more senior managers at the FDA and a rolling review of the New Drug Application (NDA).
- The FDA approves Janssen's (NYSE:JNJ) Prezcobix (darunavir/cobicistat) for the treatment, in combination with other antivirals, of adults patients with HIV-1 infection. Darunavir is protease inhibitor (sold as a single agent under the brand name Prezista by Janssen) and cobicistat is a CYP3A4 inhibitor (sold as a single agent under the brand name Tybost by Gilead (NASDAQ:GILD) Sciences).
- Eli Lilly (NYSE:LLY) Q4 results ($M): Revenues: 5,121.3 (-11.8%); COGS: 1,253.1 (-9.6%); R&D Expense: 1,290.9 (-12.5%); SG&A Expense: 1,799.9 (-7.9%); Net Income: 428.5 (-41.1%); EPS: 0.40 (-40.3%).
- Gross Profit: 3,868.2 (-12.5%); COGS: 24.5% (+2.5%); Gross Margin: 75.5% (-0.8%); Operating Earnings: 777.4 (-21.7%); Operating Earnings Yield: 15.2% (-11.2%); Net Earnings Yield: 8.4% (-33.2%).
- Key Product Sales: Alimta: 725.0 (-0.2%); Humalog: 729.1 (-0.7%); Cialis: 622.4 (+5.8%); Cymbalta: 367.3 (-58.4%); Humulin: 395.6 (+7.1%); Forteo: 380.8 (+5.8%); Zyprexa: 253.1 (-27.3%); Strattera: 194.9 (-3.1%); Effient: 137.8 (+5.5%); Evista; 72.1 (-73.9%).
- 2015 Guidance: Revenues: $19.5B - 20.0B; EPS: $2.40 - 2.50; Non-GAAP EPS: $3.10 - 3.20.
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