Oct. 31, 2014, 5:39 PM
Oct. 27, 2014, 1:14 PM
Oct. 7, 2014, 5:40 PM
Sep. 11, 2014, 9:02 AM
- Notes from this morning's call about Orexigen's (NASDAQ:OREX) Contrave:
- Over 13K patients evaluated in clinical trials. FDA specifies six post-marketing requirements (seven + studies).
- Obesity market in U.S.: 100M people. Takeda will promote via 900 sales reps. Launch this fall. Big advantage: Contrave is not a scheduled drug.
- OREX will earn $30M milestone based on FDA approval. Another $70M when launch commences. It has a co-promotion option but will not pursue at this time. Total milestone potential: $880M. Royalties: 20 - 35%.
- Company expects to end the year with ~$177M cash.
- Related tickers: (NASDAQ:ARNA) (NASDAQ:VVUS)
Sep. 11, 2014, 7:05 AM
- The FDA approves Orexigen Therapeutics' (NASDAQ:OREX) Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
- Contrave is indicated for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater who have at least one weight-related co-morbidity (e.g. hypertension, type 2 diabetes, high cholesterol).
- Takeda Pharmaceuticals will be the distributor of the product for Orexigen.
- Orexigen will conduct a conference call this morning at 8:30 am EDT to discuss Contrave's approval and launch. Interested persons can participate via 800-708-4540.
- Related tickers: (NASDAQ:ARNA) (NASDAQ:VVUS)
Sep. 2, 2014, 3:08 PM| 1 Comment
Aug. 1, 2014, 7:15 AM
- Arena Pharmaceuticals (ARNA -2.9%) Q2 results: Total Revenues: $12.8M (-81.4%); Belviq: $3.5M (+165.4%); Eisai Collaboration: $8.6M (-87.1%); R&D Expense: $27.0M (+43.5%); SG&A Expense: $9.1M (+6.1%); Operating Expenses: $38.2M (+31.5%); Operating Loss: ($25.4M) (-163.6%); Net Income: $7.5M (-81.3%); EPS: $0.03 (-83.3%); Quick Assets: $219.1M (+22.5%).
- Belviq prescriptions: 110,000.
- No guidance update provided.
- ARNA shares are up 4% premarket on light volume.
Aug. 1, 2014, 5:42 AM| 5 Comments
Jul. 31, 2014, 5:30 PM
Jul. 21, 2014, 5:38 PM
Jul. 21, 2014, 4:47 PM
- Arena Pharmaceuticals (ARNA -1.4%) subsidiary Arena Pharmaceuticals GmbH enters into an exclusive marketing and supply agreement with Teva Pharmaceuticals' local subsidiary Abic Marketing Ltd. to market and distribute Belviq in Israel for weight loss or weight management in obese and overweight patients. Abic is responsible for regulatory approval.
- Arena receives an upfront payment, regulatory-related milstones plus a one-time purchase price adjustment based on Abic's annual net sales.
Jul. 10, 2014, 8:29 AM| 1 Comment
Jul. 7, 2014, 12:24 PM
- The legitimacy of any rosy pronouncements about Belviq's prospects by Arena Pharmaceuticals (ARNA -8.4%) CEO Jack Lief has been tarnished a bit with the disclosure of his disposal of a large portion of his holdings of ARNA stock. Mr. Lief felt compelled to unload almost 40% of his stake. Such a large transaction undermines the credibility of "asset diversification" and can only be construed as bearish behavior by the most significant company insider.
- The ramp-up of Belviq sales has been underwhelming to most observers. Last quarter's sales were a modest $2.9M compared to Q2 2013's debut of $1.3M.
- ARNA's stock is down 60% from its late June 2012 peak of $13.50. 208 mutual funds have positions, down from 210 a year earlier.
- Consensus views remain bullish, however. Revenue estimates for Q2 and Q3 are $9.8M and $12.1M, respectively. Estimates for 2014 and 2015 are $43.8M and $85.7M, respectively.
- The company should report Q2 results in mid-to-late August.
Jun. 20, 2014, 10:43 AM
- Shares of new IPO Zafgen (ZFGN +1.2%) currently exchange hands for 24% above yesterday's offering price of $16 giving it a market cap of $430M. The company's lead product is beloranib, in Phase 2 clinicals to evaluate its safety and efficacy as a treatment for obesity.
- The company has yet to produce any revenue. The IPO increased its cash and cash equivalents stake to ~$126M. It has spent ~$6M/year over the past three years developing beloranib. Operations consumed $15M in cash last year.
- Related tickers: (VVUS -0.2%) (ARNA -1.2%) (OREX -2.6%)
Jun. 11, 2014, 6:18 PM
- During a CNBC Fast Money appearance, Arena (ARNA) CEO Jack Lief was tight-lipped about rumors Belviq partner Eisai (ESALY) is interested in acquiring his company.
- Investors trying to read between the lines see reasons to be hopeful.
- Lief also mentioned Belviq prescriptions are seeing week/week growth.
Jun. 9, 2014, 1:54 PM
- Orexigen Therapeutics' (OREX +0.9%) long wait for marketing clearance for its weight loss drug Contrave (naltrexone) should be over by Wednesday's PDUFA date. The company had to resubmit its NDA after conducting a study to assess Contrave's cardiovascular risk after the FDA sent the company a CRL in January 2011. Based on an interim analysis of the 8,900-patient Light Study, the data show that there was no excessive cardiovascular risk with the use of Contrave versus placebo in overweight and obese patients.
- Marketing partner Takeda Pharmaceuticals U.S.A. will launch Contrave with its 900-strong sales force. With this amount of heft it should give Vivus (VVUS -0.9%) and Arena (ARNA -1.3%) a run for their money.
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Arena Pharmaceuticals Inc is a biopharmaceutical company. The Company is engaged in discovering, developing and commercializing novel drugs that target G protein-coupled receptors, or GPCRs, to address unmet medical needs.
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