Friday, July 31, 2015
- Teva Pharmaceutical Industries (TEVA -0.3%) receives commitment letters from a group of major banks for loans totaling $33.75B, $27B under a senior unsecured Bridge Loan Credit Facility and $6.75B under an Equity Bridge Loan Credit Facility.
- Teva will use the funds to pay for its acquisition of Allergan's generic drugs business.
- In a effort to reach at least operating cash flow neutrality, struggling Vivus (VVUS -11.3%) plans to cut headquarters and sales force headcount, the latter by 50% to 50 reps. In March, it sliced its sales team by 33% to 100 from 150.
- Qsymia sales for Q2 were only $14M, up a mere $3M from a year ago. The drug was launched in the U.S. in September 2012.
- Brisbane, CA-based Aimmune Therapeutics (Pending:AIMT) is set for its IPO of 8,333,333 shares of common stock at $14 - 16.
- The clinical stage biopharmaceutical firm is developing therapeutics to treat food allergies, including those that are potentially life-threatening such as peanut. According to the company, its unique approach, called Characterized Oral Desensitization Immunotherapy ((CODIT)), is designed to desensitize patients to food allergens using rigorously characterized biologics, defined treatment protocols and tailored support services. The desensitization is achieved by the patient ingesting increasing amounts of the allergen, precisely controlled, over a period of months.
- Its lead product candidate is Fast Track- and Breakthrough Therapy-designated AR101 for the treatment of peanut allergy, a condition affecting 5M Americans including 2M children. A Phase 3 trial should commence soon.
- 2014 Financials ($M): Operating Expenses: 11.1 (+134.0%); Net Loss: (11.1) (-130.5%); Cash Burn: (4.0) (-104.9%).
- Balmain, Australia-based Benitec Biopharma (Pending:BNTC) is set for its IPO of 5M American Depositary Shares (ADSs). Each ADS represents 20 ordinary shares. The company currently trades on the Australian Securities Exchange under the symbol "BLT." The estimated price per ADS will be ~$13.00.
- The clinical stage biotech is developing a proprietary therapeutic technology platform called DNA-directed RNA interference (ddRNAi) that combines gene silencing and gene therapy. Its goal is to provide a "one shot" cure for a variety of diseases via the long-term silencing disease-causing genes. Its pipeline programs target hepatitis C, hepatitis B, age-related macular degeneration, drug-resistant non-small cell lung cancer and oculopharyngeal muscular dystrophy.
- 2014 Financials (A$M): Total Revenues: 1.4 (-6.2%); Operating Expenses: 8.9 (+79.1%); Net Loss: (7.0) (-101.8%); Cash Burn: (9.3) (-239.2%).
- Envision Healthcare (EVHC +10.2%) enters a definitive agreement to acquire rival Rural/Metro for $620 million.
- Rural/Metro is expected to generate annualized 2015 revenue of approximately $600 million. Upon closing, the transaction is expected to be accretive to Envision's earnings.
- The pending acquisition is hinged on regulatory approval and closing conditions, and is expected to close 4Q 2015.
- ResMed (RMD +4%) FQ4 results: Revenues: $453.1M (+9.1%); COGS: $188.6M (+22.5%); R&D Expense: $28.5M (-10.4%); SG&A: $123.3M (+0.9%); Operating Income: $99.5M (+1.0%); Net Income: $87.5M (-0.2%); EPS: $0.61 (unch).
- FY2015 results: Revenues: $1,678.9M (+8.0%); COGS: $662.5M (+17.2%); R&D Expense: $114.9M (-2.8%); SG&A: $472.6M (+4.9%); Operating Income: $409.2M (+1.0%); Net Income: $352.9M (+2.2%); EPS: $2.47 (+3.3%); Quick Assets: $717.2M (-20.8%).
- No guidance given.
- Molina Healthcare (MOH +10.7%) is trading up sharply on heavy volume after Q2 2015 earnings release on July 30. Stifel upgrades coverage from Hold to Buy, with a price target of $88.00.
- Molina beat EPS estimates by $.09, but missed on revenues by $100 million.
- Previously: Molina Healthcare beats by $.09, misses on revenue (Jul. 30 2015)
- PerkinElmer (PKI +2.1%) Q2 results: Revenues: $563.9M (+1.4%); COGS: $311.4M (+1.0%); R&D Expense: $32.7M (+7.6%); SG&A: $146.7M (-0.4%); Operating Income: $68.1M (-2.2%); Net Income: $49M (-5.8%); EPS: $0.43 (-6.5%); Quick Assets: $192.2M (+10.0%).
- 2015 Guidance: GAAP EPS: $2.00 - 2.05; Non-GAAP EPS: $2.55 - 2.60.
- Shares of thinly-traded Pure Bioscience (OTCQB:PURE -8.7%) are falling after the resignation of Peter C. Wulff, CFO and COO. Wulf has accepted a new assignment as CFO for a venture-backed medical device company.
- Mark Elliott, Pure's Controller, will assume Wulff's role in Pure's Finance department as Vice President, Finance and will serve as principal financial and accounting officer.
- The FDA approves Bayer Healthcare's (OTCPK:BAYRY -0.1%) Finacea (azelaic acid) Foam 15% for the topical treatment of the inflammatory papules and pustules of mild-to-moderate rosacea. Papulopustular rosacea is a skin disease that causes inflammatory lesions in the nose, cheeks, chin and forehead.
- Finacea Foam was developed in collaboration with Foamix Pharmaceuticals (FOMX +7.9%). Foamix will earn royalties and milestone payments from Bayer upon the commercialization of Finacea, which utilizes its proprietary foam technology platform. The U.S. launch will commence in September.
- LifePoint Hospitals (LPNT -3.9%) Q2 results: Revenues: $1,270.4M (+21.3%); Salaries and benefits: $606.8M (+24.2%); Supplies: $194.1M (+19.4%); Other operating expenses: $308.7M (+19.5%); Net Income: $46.4M (+18.7%); EPS: $1.00 (+19.0%); Quick Assets: $422.8M (+120.8%).
- 2015 Guidance: Net Revenue: $5.15B - 5.25B; Adjusted EBITDA: $695M - 720M; Adjusted EPS: $3.75 - 4.06.
9:59 AM| 1 Comment
- ADMA Biologics (ADMA) submits a Biologics License Application (BLA) to the FDA seeking marketing clearance for its lead product candidate, RI-002, for the treatment of patients with primary immunodeficiency (PI). The FDA has 60 days to review the submission for completeness.
- RI-002 is a specialty human plasma-derived, polyclonal, intravenous immune globulin (IGIV) that contains antibodies to Streptococcus pneumoniae, H. influenza type B, cytomegalovirus, measles, tetanus, respiratory syncytial virus and others. Clinical trial results showed that RI-002 prevents infections in immune-compromised patients.
- Cintas (CTAS +0.4%) announces that it will acquire Zee Medical from McKesson Corporation (MCK +0.2%) for consideration of approximately $130 million in cash.
- The company expects the acquisition to generate annual revenue of $110 million to $120 million, expanding its footprint in van delivered first aid, safety, training and emergency products, and building its customer base in North America.
- The transaction is expected to close on August 1, 2015.
- ImmunoGen (IMGN -2.23%) FQ4 results: Revenues: $12.6M (+121.1%); R&D Expense: $30.4M (+17.8%); SG&A: $7.3M (+12.3%); Operating Loss: ($25.1M) (+5.3%); Net Loss: ($30.5M) (-15.1%); Loss Per Share: ($0.35) (-12.9%).
- FY2015 results: Revenues: $85.5M (+42.7%); R&D Expense: $111.8M (+4.5%); SG&A: $28.2M (+15.1%); Operating Loss: ($54.5M) (+23.8%); Net Loss: ($60.7M) (+15.0%); Loss Per Share: ($0.71) (+14.5%); Quick Assets: $278.1M (+95.4%).
- 2016 Guidance: Revenues: $70M - 80M; operating expenses: $175M - 180M; net loss: ($120M - 125M); cash burn: ($100M - 105M); capex: $13M - 15M; quick assets at fiscal year end: $165M - 170M.
- MannKind (MNKD) shares fall 3% premarket on light volume as partner Sanofi (SNY) reports that sales of MannKind's fast-acting inhaled insulin product Afrezza slump in 2Q 2015. Reported sales were $2.2 million.
- Analysts widely expected a sales disappointment for Afrezza in Q2 as a result of minimal insurance coverage and lack of marketing focus.
- Despite lackluster sales, MannKind announces it will triple production capacity to support the Afrezza launch. With the added capacity, the company expects to support a demand of more than 300 million cartridges per year.
- The USPTO issues a Notice of Allowance (NOA) for Horizon Pharma's (NASDAQ:HZNP) patent application number 13/665,790 titled, "Treatment of Pain with Topical Diclofenac" which covers PENNSAID (diclofenac sodium topical solution) 2%.
- The U.S. patent, when issued, will be effective until July 10, 2029. It is the eleventh patent covering PENNSAID.
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