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Tue, May 10, 8:23 AM
- Allergan (NYSE:AGN) Q1 results ($M): Total Revenues: 3,795.9 (+48.1%); Net Income: 255.7 (+149.9%); Non-GAAP Net Income: 1,269.0 (+60.7%); EPS: 0.47 (+125.4%); Non-GAAP EPS: 3.04 (+14.7%); CF Ops: 1,218.5 (+132.1%). Consensus: EPS of $3.01 on revenues of $3.95B.
- U.S. Brands: Net Revenues: 2,302.7 (+27.3%); Central Nervous System: 554.3 (+1.2%); Eye Care: 533.0 (+462.8%); Gastroenterology: 403.6 (+10.1%); Women's Health: 263.7 (+15.0%); Urology: 74.1 (+98.7%); Infectious Disease: 51.5 (+22.9%).
- U.S. Medical Aesthetics: 449.7 (+463.5%); Facial Aesthetics: 279.4 (+693.8%); Medical Dermatology & Other: 122.2 (+300.7%); Plastic Surgery: 48.1 (+241.1%).
- Key Product Sales: Botox: 637.5 (+658.9%); Fillers: 214.7 (+772.8%); Namenda XR: 173.1 (+14.9%); Lumigan/Ganfort: 169.6 (+700.0%); Bystolic: 164.0 (0.0%); Linzess/Constella: 140.9 (+46.5%).
- 2016 Guidance: Non-GAAP Net Revenues: ~$17B; Non-GAAP R&D Investment: ~$1.5B; SG&A: ~25% of Non-GAAP Net Revenues; Non-GAAP Tax Rate: ~14%.
- Q2 Consensus: EPS of $3.40 on revenues of $4.17B.
Tue, May 10, 7:33 AM
Mon, May 9, 5:30 PM| Mon, May 9, 5:30 PM | 1 Comment
Mon, May 9, 7:26 AM
- Allergan (NYSE:AGN) announces successful results from one of two U.S. Phase 3 clinical trials assessing Gedeon Richter's ulipristal acetate for the treatment of uterine fibroids. Data from both studies, called Venus 1 and Venus II, will support a New Drug Application in 2017.
- Venus 1 enrolled 157 premenopausal women with cyclic abnormal uterine bleeding in at least four of their last six menstrual cycles, menstrual blood loss at least 80 mL over the first eight days of menses, at least one uterine fibroid of any size, follicle-stimulating hormone no more than 20 mIU/mL and uterine volume no more than 20 weeks by exam. Participants were randomized 1:1:1 to receive either 5 mg or 10 mg of ulipristal acetate or placebo for 12 weeks followed by a 12-week follow-up period. The study met all co-primary and secondary endpoints (the co-primary endpoints were the percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding). The percentages of patients achieving absence of bleeding in the 5 mg, 10 mg and placebo cohorts were 47.2% (p<0.0001), 58.3% (p<0.0001) and 1.8%, respectively.
- There were no treatment-related serious adverse events and no patients discontinued treatment with ulipristal acetate due to adverse events. The common treatment-related adverse events were hypertension (n=6), increased blood creatine phosphokinase (n=5), hot flush (n=5) and acne (n=3).
- Ulipristal acetate is a selective progesterone receptor modulator that acts directly on the progesterone receptors in the endometrium, uterine fibroids and the pituitary gland. It is marketed in Europe by Gedeon Richter under the brand name Esmya. It was approved by Health Canada in June 2013 under the brand name Fibristal.
- Gedeon and Watson Laboratories inked a deal to develop and market Esmya in the U.S. and Canada in December 2010. Watson was subsequently acquired by Actavis in November 2012 which acquired Allergan in March 2015.
Fri, May 6, 10:58 AM
- Thinly traded micro cap Cardiome Pharma (CRME +27.5%) is up on an 8x surge in volume, albeit on turnover of only 290K shares, in response to its announcement that it has inked a deal with an affiliate of Allergan (AGN -4.5%) (Actavis, presumably) for the commercialization rights to antibiotic XYDALBA (dalbavancin) in France, the U.K., Germany, Belgium, Nordic countries, certain countries in the Middle East, Canada and unnamed others. XYDALBA was approved in May 2014 in the EU for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSIs).
- Under the terms of the deal, Cardiome will pay Allergan a staggered upfront fee of $13M, milestones and royalties. Additional terms are not disclosed.
- Cardiome intends to launch XYDALBA in its territories this year.
- Related ticker: (TEVA -6.2%)
Fri, May 6, 2:10 AM
- Teva Pharmaceutical (NYSE:TEVA) is finalizing as much as $2B in asset sale agreements to win U.S. antitrust clearance for its $40.5B acquisition of Allergan's (NYSE:AGN) generic drug portfolio, according to Reuters.
- Teva said in March that a regulatory review of the deal by the Federal Trade Commission was taking longer than anticipated, and that it expected the transaction to be completed by June.
Fri, Apr. 29, 10:54 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Allergan's (AGN -1.4%) ENZEPI (pancrelipase), a pancreatic enzyme replacement therapy for patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions like chronic pancreatitis or pancreatic cancer.
- Patients with EPI cannot digest food normally and run the risk of becoming malnourished. ENZEPI contains enzymes necessary to metabolize fats, proteins and sugars.
- A final decision from the European Commission usually takes ~60 days.
Fri, Apr. 22, 7:17 AM
- Sarepta Therapeutics (NASDAQ:SRPT) initiated with Neutral rating and $19 (73% upside) price target by Janney Capital.
- Alder BioPharma (NASDAQ:ALDR) initiated with Buy rating and $45 (61% upside) price target by Brean Capital.
- Pacira Pharmaceuticals (NASDAQ:PCRX) initiated with Buy rating and $79 (27% upside) price target by Mizuho Securities.
- McKesson initiated with Market Perform rating and $203 (14% upside) price target by Avondale Partners.
- Pfizer (NYSE:PFE) reinstated coverage with Neutral rating and $35 (6% upside) price target by Goldman Sachs.
- Allergan (NYSE:AGN) reinstated with Buy rating and $275 (21% upside) price target by Goldman Sachs. Downgraded to Neutral from Overweight by Piper Jaffray. Price target lowered to $238 (5% upside) from $311.
- Illumina (NASDAQ:ILMN) upgraded to 5.0 stars from 3.0 stars the Vetr community. Downgraded to Neutral by Bank of America with lowered price target of $180 (24% upside). Downgraded Hold from Buy by Cantor Fitzgerald and price target lowered to $165 (14% upside) from $225. Mizuho maintains Neutral rating and $150 (3% upside) price target.
- Sucampo Pharmaceuticals (NASDAQ:SCMP) upgraded to Buy from Neutral by Mizuho Securities. Price target maintained at $14 (19% upside).
- Medivation (NASDAQ:MDVN) upgraded to Buy from Hold by Canaccord Genuity. Price target raised to $70 (31% upside) from $45.
Thu, Apr. 21, 5:30 PM
- Allergan (NYSE:AGN) acquires privately held Boston, MA-based Topokine Therapeutics, a developer of topical medicines that act on subcutaneous fat to contour the face and body without surgery or injections. Its lead product candidate is XAF5 Ointment, in Phase 3 development for the treatment of bags under the eyes (steatoblepharon).
- Under the terms of the deal, Topokine will receive an upfront payment of $85M plus unspecified milestones related to XAF5.
Fri, Apr. 15, 3:44 PM
- Allergan (NYSE:AGN) is the purported suitor.
- SGYP +6.5%
- Now read: Why The Termination Of The Allergan-Pfizer Deal Isn't Too Bad After All (April 6)
Fri, Apr. 8, 11:05 AM
- MacroGenics (MGNX +3.1%) initiated with Buy rating and $35 price target by BTIG Research.
- Viking Therapeutics (VKTX -39.4%) initiated with Buy rating and $6 price target by H.C. Wainwright.
- Pfizer (PFE -0.3%) initiated with an Overweight rating and $38 price target by JP Morgan.
- Medivation (MDVN -0.1%) initiated with Buy rating and $56 price target by SunTrust Robinson Humphrey.
- Eyegate Pharmaceuticals (EYEG +6.5%) initiated with Buy rating and $10 price target by Noble Financial.
- Eiger Biopharmaceuticals (EIGR +0.5%) initiated with Buy rating and $35 price target by Jefferies.
- Vertex Pharmaceuticals (VRTX +0.3%) initiated with Market Perform rating and a $90 price target by BMO Capital.
- SocGen has been busy with initiations on six large cap pharmas: Buy: Merck (MRK +0.1%); Hold: Johnson & Johnson (JNJ -0.4%), Eli Lilly (LLY -0.3%) and Pfizer; Sell: Bristol-Myers Squibb (BMY -0.4%) and AbbVie (ABBV -0.9%).
- Tokai Pharmaceuticals (TKAI -6.7%) initiated with Buy rating and $16 price target by Bank of America. Initiated with Buy rating by Janney Capital.
- Cellectis (CLLS -0.1%) initiated with Buy rating and $45 price target by Ladenburg Thalmann.
- Novartis (NVS +0.5%) initiated with Hold rating by Argus Research.
- TherapeuticsMD (TXMD) initiated with Buy rating and $10 price target by Goldman Sachs.
- Protalix (PLX -4.2%) initiated with Buy rating and $3.50 price target by Rodman & Renshaw.
- Raptor Pharmaceuticals (RPTP -0.4%) upgraded to Outperform from Market Perform by JMP Securities.
- Ironwood Pharmaceuticals (IRWD -0.6%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $16 from $12.
- Intercept Pharmaceuticals (ICPT -6%) upgraded to Outperform from Market Perform by Wells Fargo.
- Edwards Lifesciences (EW -0.1%) upgraded to Buy from Neutral with $115 price target by BTIG Research.
- Express Scripts (ESRX +0.7%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $80 from $76.
- BIND Therapeutics (BIND -7%) downgraded to Market Perform from Outperform by Cowen & Company.
- Allergan (AGN -0.5%) downgraded to Neutral from Buy by Mizuho Securities. Downgraded to Neutral from Positive by Susquehanna. Price target lowered to $275 from $345.
- Bruker (BRKR +0.2%) downgraded to Market Perform from Outperform by Leerink Swann. Price target is $27.
Fri, Apr. 8, 9:50 AM
- Avondale's Greg Bolan believes the near-term outlook for contract research organizations (CROs) is unfavorable due to big pharma's appetite for significant deals, bolstered by the failed Allergan (AGN +0.7%)/Pfizer (PFE -0.8%) marriage. The reason is that when a big acquisition is on the table, clinical trial-related activity freezes up due to the potential change in R&D priorities that frequently follows the transactions.
- Related tickers: (Q +0.6%)(PRAH -1.2%)(ICLR +0.5%)(PRAH -1.2%)(CRL -0.5%)(PRXL)
Wed, Apr. 6, 7:46 PM
- Moving on from a broken merger, Allergan (AGN +3.6%) says it's formed a global R&D and commercialization partnership with Heptares Therapeutics (OTCPK:SOLTF) to pursue novel treatments for neurological disorders.
- Allergan will issue an up-front payment of $125M, and Heptares is eligible for milestone payments of up to $665M contingent on successful Phase 1, 2 and 3 development and launch of the first three licensed compounds for multiple indications, along with royalties and up to $2.5B tied to sales thresholds.
- The two will work to develop and commercialize small molecule agonists targeting muscarinic receptors in the brain, to address Alzheimer's and related disorders.
- Now read The Allergan-Pfizer Merger Is Now Dead, But Allergan Isn't »
Wed, Apr. 6, 7:26 AM
- Although disheartened that its merger with Pfizer (NYSE:PFE) is dead, Allergan (NYSE:AGN) is bullish on its standalone profile. CEO Brent Saunders says, "While we are disappointed that the Pfizer transaction will no longer mover forward, Allergan is poised to deliver strong, sustainable growth built of a set of powerful attributes. Our pipeline is one of the strongest in the industry, loaded with 70 mid-to-late-stage programs including 14 expected approvals and 16 regulatory submissions in 2016 alone."
- Based on a preliminary review of the proposed regulations from the U.S. Treasury Department, the company believes they will not have a material impact on its standalone tax rate. Q1 earnings will be reported no later than May 10. During the conference call, management will update investors on its plans to simplify the company's operations after it divests its generics business to (NYSE:TEVA).
- Allergan will host a brief conference call this morning at 10:00 am ET to discuss its standalone prospects.
- Pfizer says it will make a decision on splitting the company's innovative and established businesses by the end of the year. It will report Q1 results on May 3. It has agreed to reimburse Allergan $150M for merger-related expenses.
- PFE is up 1% and AGN is down 1% premarket.
Tue, Apr. 5, 9:17 PM
- Pfizer (PFE +2.2%) and Allergan (AGN -15%) are set to mutually terminate their merger in the morning, David Faber reports in news that's not entirely unexpected.
- The change to tax inversion regulations gave the deal a "death blow," he says.
- Updated 9:46 p.m.: Pfizer will pay Allergan a $400M breakup fee in keeping with the companies' agreement.
- Previously: Pfizer mulling backing out of Allergan deal (Apr. 05 2016)
- Previously: Allergan -19% following Secretary Lew’s remarks on corporate tax inversions (Apr. 05 2016)
- Now read Pfizer Is A Winner With Or Without Allergan »
Tue, Apr. 5, 1:46 PM
- According to sources, Reuters reports that Pfizer (PFE +3.2%) is leaning toward abandoning the Allergan (AGN -16.4%) deal if the tax benefits are not there.
- Previously: Allergan -19% following Secretary Lew’s remarks on corporate tax inversions (April 5)
Allergan Plc operates as an investment holding company. It is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand, brand generic, over-the-counter and biosimilar products. The company operates through the following segments:... More
Industry: Drug Manufacturers - Other
Country: United States
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