Will AstraZeneca Get Bought After All?
Chris DeMuth Jr. • 20 Comments
Chris DeMuth Jr. • 20 Comments
The Preferred Way To Play The Allergan-Pfizer Break Up
Andrew Walker, CFA • 56 Comments
Andrew Walker, CFA • 56 Comments
Mon, Oct. 17, 4:24 PM
Fri, Oct. 14, 6:49 AM
- Merck (NYSE:MRK) upgraded to Buy from Neutral by Bank of America. Price target raised to $70 (12% upside) from $57.
- HCA Holdings (NYSE:HCA) upgraded to Overweight from Sector Weight by KeyBanc.
- Momenta Pharmaceuticals (NASDAQ:MNTA) upgraded to Overweight from Equal Weight by Barclays. Price target raised to $19 (54% upside) from $13.
- TESARO (NASDAQ:TSRO) upgraded to Buy from Neutral with a $123 (6% upside) price target by Bank of America.
- Pfizer (NYSE:PFE) downgraded to Hold from Buy with a $36 (10% upside) price target by Jefferies.
- Theravance Biopharma (NASDAQ:TBPH) downgraded to Underperform from Neutral by Baird. Price target raised to $24 (25% downside risk) from $19.
- Ilumina (NASDAQ:ILMN) downgraded to Sell from Neutral by Janney Montgomery Scott. Price target lowered to $125 (9% downside risk) from $155. Downgraded to Neutral from Buy by Citigroup. Price target lowered to $140 (2% upside) from $190.
- Myriad Genetics (NASDAQ:MYGN) downgraded to Sell from Neutral with a $16 (14% downside risk) price target by Ladenburg Thalmann.
Thu, Oct. 13, 10:42 AM
- Esperion Therapeutics (ESPR +10.5%) perks up in early trading in response to its announcement that patients with hypercholesterolemia (elevated LDL-C) who are being treated with any dose of statins will be included in its Phase 3 development program for bempedoic acid. A pivotal trial, CLEAR LDL-C, should commence by year end with top-line results expected in mid-2018. If all goes well, regulatory submissions will follow in H1 2019.
- Its decision was based on positive top-line results from its eight-week Phase 2 study of bempedoic acid added to atorvastatin (Pfizer's (PFE -0.9%) LIPITOR) which showed a 22% reduction in LDL-C from baseline compared to placebo (p=0.0028) against a background of atorvastatin in all subjects. The administration of bempedoic acid also produced a 35% reduction in C-reactive protein, a biomarker of cardiovascular disease-related inflammation.
- Bempedoic acid is a small molecule that lowers cholesterol without the side effects associated with statins. Once in the liver, it converts into a derivative coenzyme which directly inhibits an enzyme called ATP citrate lyase (ACL) which plays a key role in cholesterol and fatty acid synthesis.
Mon, Oct. 10, 10:50 AM
- Results from a Phase 3 clinical trial, S-TRAC, assessing Pfizer's (PFE +0.6%) SUTENT (sunitinib malate) in an adjuvant setting for the treatment of patients with renal cell carcinoma (RCC) showed a positive effect in extending disease-free survival (DFS). The data will be presented today at the European Society for Medical Oncology 2016 Annual Meeting in Copenhagen.
- S-TRAC showed that RCC patients treated with SUTENT who were at high risk of recurrence after undergoing surgical resection of their cancer experienced median DFS of 6.8 years compared to 5.6 years for placebo after one year of therapy in addition to a 24% reduction in overall risk.
- The company is discussing the next steps with global regulatory authorities. SUTENT is approved in the U.S. for treating gastrointestinal stromal tumors, RCC and pancreatic neuroendocrine tumors.
Mon, Oct. 10, 7:46 AM
- Exelixis (NASDAQ:EXEL) is up 8% premarket on light volume in response to its announcement of positive results from a Phase 2 clinical trial, CABOSUN, assessing CABOMETYX (cabozantinib) compared to Pfizer's (NYSE:PFE) SUTENT (sunitinib malate) in treatment-naive patients with advanced renal cell carcinoma (RCC). The data were presented at the European Society for Medical Oncology 2016 Annual Meeting in Copenhagen.
- With a median follow-up period of 20.8 months, patients treated with cabozantinib experienced 31% less risk of death or cancer progression (hazard ratio: 0.69) than those treated with sunitinib. Median progression-free survival (PFS) in the cabozantinib cohort was 8.2 months versus 5.6 months for sunitinib. Median overall survival (OS) also favored cabozantinib (30.3 months vs. 21.8 months) as did the objective response rate (ORR) (46% vs. 18%).
- Exelixis plans to submit a supplement New Drug Application (sNDA) with the FDA as soon as feasible.
- CABOMETYX is currently approved in the U.S. for the treatment of RCC. SUTENT is approved in the U.S. for treating gastrointestinal stromal tumors, RCC and pancreatic neuroendocrine tumors.
- The company and commercialization partner Ipsen will host a conference call today at 1:00 pm ET to discuss the data.
Thu, Oct. 6, 3:32 PM
- Biotech investors are sitting on the sell button today. The iShares Nasdaq Biotechnology ETF (IBB -2.4%) is down on increased volume. Shares have retraced over 5% since the recent close of 300 on September 22.
- Alnylam (ALNY -48%) is leading the rout after it announced that it was dropping development of RNAi candidate revusiran.
- Representative tickers: (AMGN -0.3%)(BIIB -1.3%)(GILD -1.9%)(CELG -1.4%)(BMY)(MRK -0.7%)(PFE -1.2%)(VRTX -3%)(ALXN -2.2%)
Thu, Oct. 6, 8:40 AM
- ICU Medical (NASDAQ:ICUI) inks an agreement with Pfizer (NYSE:PFE) to purchase its global infusion therapy business for $1B in cash and stock. Pfizer acquired it when it bought Hospira in September 2015.
- The business, Hospira Infusion Systems, includes IV pumps, solutions and devices. The transaction will increase ICUI's annual revenues to ~$1.45B and create a leading pure-play infusion therapy company.
- Under the terms of the agreement, Pfizer will receive ~$400M in newly issued ICUI stock and $600M in cash. The deal should close in Q1. Afterward, Pfizer will own 16.6% of ICU.
- For Q3, ICUI expects $1.20 in non-GAAP EPS on revenues of $96M. For 2016, it sees $4.60 in non-GAAP EPS on revenues of greater than $370M, the high end of the range of its previously reported guidance.
- ICUI shares are up 7% premarket, but only on 100 shares.
Wed, Oct. 5, 11:21 AM
- Slingshot Insights is hosting an exert interview today at 2:00 pm ET focused on non-alcoholic steatohepatitis (NASH), a sizable market opportunity for drug makers that many call the "next hepatitis C." The space has heated up recently stoked by Allergan's (NYSE:AGN) $1.7B takeout of Tobira Therapeutics (NASDAQ:TBRA) and $50M acquisition of privately held Akarna Therapeutics.
- SA subscribers should use their 90-day coupon code SA_Sub16.
- NASH-related tickers: (NYSE:PFE)(NASDAQ:GALT)(NASDAQ:BLRX)(NASDAQ:GLMD)(NASDAQ:CNAT)(NASDAQ:MNOV)(NASDAQ:RGLS)(NASDAQ:ICPT)(NASDAQ:SHPG)(NYSEMKT:CANF)(NASDAQ:VBLT)(OTCPK:ISLT)(OTCPK:GNFTF)(NASDAQ:GILD)
Mon, Oct. 3, 10:47 AM
- September monthly performance was: +0.2%
- 52-week performance vs. the S&P 500 is: +7%
- $0.21 in dividends were paid in September
- Top 10 Holdings as of 8/31/2016: AT&T Inc (T): 5.38068%, Exxon Mobil Corp (XOM): 5.11766%, Verizon Communications Inc (VZ): 4.15514%, Chevron Corp (CVX): 3.62745%, General Electric Co (GE): 3.46929%, Procter & Gamble Co (PG): 3.13406%, Wal-Mart Stores Inc (WMT): 2.92688%, Pfizer Inc (PFE): 2.90452%, Philip Morris International Inc (PM): 2.83223%, Merck & Co Inc (MRK): 2.39541%
Mon, Oct. 3, 9:47 AM
- September monthly performance was: -0.52%
- 52-week performance vs. the S&P 500 is: -11%
- $0.16 in dividends were paid in September
- Top 10 Holdings as of 8/31/2016: Apple Inc (AAPL): 5.01757%, Microsoft Corp (MSFT): 4.59213%, Exxon Mobil Corp (XOM): 3.65506%, Johnson & Johnson (JNJ): 3.32616%, General Electric Co (GE): 2.90192%, Procter & Gamble Co (PG): 2.3854%, Wells Fargo & Co (WFC): 2.34646%, Pfizer Inc (PFE): 2.17377%, JPMorgan Chase & Co (JPM): 2.08563%, Amazon.com Inc (AMZN): 2.02582%
Mon, Oct. 3, 9:10 AM
- September monthly performance was: +0.58%
- 52-week performance vs. the S&P 500 is: -9%
- $0.23 in dividends were paid in September
- Top 10 Holdings as of 8/31/2016: Apple Inc (AAPL): 3.96271%, Microsoft Corp (MSFT): 3.09853%, Johnson & Johnson (JNJ): 2.24259%, General Electric Co (GE): 1.95493%, Exxon Mobil Corp (XOM): 1.64204%, Procter & Gamble Co (PG): 1.33805%, Wells Fargo & Co (WFC): 1.31607%, Pfizer Inc (PFE): 1.21901%, Nestle SA (OTCPK:NSRGF): 1.15897%, Intel Corp (INTC): 1.14963%
Wed, Sep. 28, 9:46 AM
- Teva Pharmaceutical Industries (TEVA +0.5%) announces its U.S. commercial launch of a generic equivalent to ViiV Healthcare's Epzicom (abacavir and lamivudine) tablets, 600 mg/300 mg. It is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection.
- According to IMS, the U.S. market for the branded product is ~$450M.
- ViiV Healthcare is the HIV-focused company formed by GlaxoSmithKline (GSK +0.9%) and Pfizer (PFE +0.1%).
Mon, Sep. 26, 7:25 AM
- After what it calls an "extensive evaluation" to assess the feasibility and potential to maximize shareholder value by splitting into two publicly traded companies, Pfizer Innovative Health and Pfizer Essential Health, Pfizer (NYSE:PFE) decides to stay the course with its current corporate structure.
- Chairman & CEO Ian Read says, "With this decision, our two distinct businesses will remain separately managed units with Pfizer, which we believe is currently the best structure to continue to deliver on our commitments to patients, physicians, payers and governments, and to drive value for our shareholders. We believe that by operating two separate and autonomous units within Pfizer we are already accessing many of the potential benefits of a split - sharper focus, increased accountability and a greater sense of urgency - while also retaining the operational strength, efficiency and financial flexibility of operating as a single company as compared with operating as two, separate publicly traded companies. We will continue to generate the financial information necessary to preserve our option to split our business should factors materially change at some point in the future."
- EVP, Business Operations and CFO Frank D'Amelio adds, "When we first explored the trapped value question several years ago, market valuations of other companies suggested that our two businesses could potentially be worth more as separate companies than they are together in a single company. However, over time, any potential gap between Pfizer's market valuation and an implied Sum of the Parts market valuation has closed. In our analysis, we concluded that splitting into two companies at this time would not enhance the cash flow generation and competitive positioning of the businesses and the operational disruption, increased costs of a split and inability to realize any incremental tax efficiencies would likely be value destructive."
- The company reaffirms its financial guidance issued on August 2.
- Shares are down 1% premarket on light volume.
Thu, Sep. 22, 12:00 PM
Sat, Sep. 17, 5:13 PM
- A Phase 3 clinical trial, REFLECTIONS B537-02, assessing Pfizer's (NYSE:PFE) Remicade (infliximab) biosimilar candidate, PF-06438179 (infliximab-Pfizer) in patients with rheumatoid arthritis (RA) met its primary endpoint demonstrating equivalent efficacy with Remicade as measured by the number of participants achieving ACR20 (20% improvement in RA symptoms) at Week 14 of treatment. According to ClinicalTrials.gov, the estimated study completion date is May 2017.
- PF-06438179 is in development for all approved indications of Remicade, Janssen's (NYSE:JNJ) top seller at almost $6.9B (most recent four quarters).
- Novartis' (NYSE:NVS) Sandoz unit has commercialization rights to PF-06438179 in the European Economic Area (28 countries) while Pfizer retains the rights elsewhere.
Fri, Sep. 16, 7:55 AM
- The European Medicines' Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Pfizer's (NYSE:PFE) IBRANCE (palbociclib) for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. CHMP's opinion specifies that IBRANCE be used in combination with an aromatase inhibitor [i.e., AstraZeneca's (NYSE:AZN) Arimidex (anastrozole)] and in combination with fulvestrant (AZN's FASLODEX) in women who have received prior endocrine therapy.
- Palbociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6, downstream signaling pathways which lead to cellular proliferation. When combined with an antiestrogen, it inhibits the growth of breast cancer by interfering with these pathways and promoting the deterioration of cancer cells (senescence).
- A final decision by the European Commission usually takes ~60 days.
- The FDA approved IBRANCE in 2015.