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Actavis plc. (ACT)

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  • Dec. 5, 2014, 3:44 PM
    • The FDA's Anti-Infective Drugs Advisory Committee voted as follows in its review of Cerexa's (ACT -0.7%) NDA for ceftazidime/avibactam:
    • Question 1: 11 - 1 that CAZ-AVI NDA demonstrated substantial evidence of safety/efficacy in complicated intra-abdominal infections.
    • Question 2: 9 - 3 that CAZ-AVI NDA demonstrated substantial evidence of safety/efficacy in complicated urinary tract infections.
    • Question 3: 12 - 0 that CAZ-AVI NDA failed to show evidence of safety/efficacy in aerobic Gram-negative infections where patients had limited or no alternatives.
    • Question 4: 11 - 1 that CAZ-AVI NDA failed to show evidence of safety/efficacy in aerobic Gram-negative infections when no adequate treatments are available.
    • Previously: Ad Comm review approaches for Actavis anti-infective combo (Dec. 3, 2014)
    • Related ticker: (AZN -0.3%)
    | Comment!
  • Dec. 3, 2014, 1:46 PM
    • The FDA's Anti-Infective Drugs Advisory Committee meets on Friday, December 5 to review the New Drug Application (NDA) submitted by Cerexa for the combination of ceftazidime/avibactam (CAZ-AVI) for the treatment of complicated intra-abdominal infections, complicated urinary tract infections and acute pyelonephritis. The NDA also includes a limited use indication for patients with aerobic Gram-negative infections with limited treatment options.
    • The FDA designated CAZ-AVI a Qualified Infectious Disease Product (QIDP) in March 2013. Among the benefits of the tag is a five-year period of market exclusivity if approved.
    • Cerexa was acquired by Forest Labs in 2006 for $480M. Forest was acquired by Actavis (ACT +0.5%) for $25B this year.
    • Briefing doc and addendum
    • Related ticker: (AZN +1.6%)
    • Previously: AstraZeneca reports top-line results from Phase 3 antibiotic trials
    | Comment!
  • Nov. 25, 2014, 2:42 AM
    • After agreeing to buy Allergan (NYSE:AGN) this month for $66B, Actavis (NYSE:ACT) is now planning to announce a series of job cuts, Bloomberg reports.
    • Actavis CEO Brent Saunders says there are overlaps in corporate functions, including human relations and finance, though he hasn’t yet quantified how many positions will be eliminated.
    • Actavis is also planning to expand in China with generic and brand-name medicines and Allergan’s Botox.
    | Comment!
  • Nov. 21, 2014, 1:51 AM
    • Valeant Pharmaceuticals (NYSE:VRX) has slashed its stake in Allergan (NYSE:AGN) to 0.1% from 9.7%, three days after Actavis (NYSE:ACT) trumped its offer for the Botox maker.
    • Pershing Square and Valeant have now sold all 2.2M Allergan in PS Fund 1, a shell fund that was set up by the two to act as a joint acquisition vehicle.
    • VRX -0.8% AH
    | Comment!
  • Nov. 18, 2014, 12:06 PM
    • The U.S. Court of Appeals for the Federal Circuit rules in favor of generic firms, including Teva Pharmaceutical Industries (TEVA), in Roche's and Warner-Chilcott's (ACT +6.5%) patent infringement suit over Roche's branded osteoporosis med Actonel at a monthly dose of 150 mg (Warner licensed the product from Roche).
    • From August 2008 to February 2011, Teva, Apotex, Mylan Pharmaceuticals (MYL +1.7%) and Sun Pharma all filed ANDAs to sell generic Actonel 150 mg tablets.
    | Comment!
  • Nov. 17, 2014, 5:40 PM
    • Top gainers, as of 5:15 p.m.: AVB +4.9%. CLVS +3.1%. GLW +2.5%. ACT +2.3%. DHX +2.1%.
    • Top losers, as of 5:15 p.m.: OME -19.2%. URBN -4.8%. FOLD -3.4%. RMTI -3.2%. PF -2.7%.
    | Comment!
  • Nov. 17, 2014, 12:22 PM
    • It's doubtful that Pershing Square's Bill Ackman is disappointed that Valeant Pharmaceutical (VRX +0.3%) lost out to Actavis (ACT +1.9%) in a bid for Allergan (AGN +5.7%) considering the tidy $2.6B profit he'll bag on his 9.7% stake in the Botox maker.
    • Pershing Square acquired 28.9M shares of AGN at $129.28 and will sell at $219. Doing the math: ($219 - 129.28) x 28.9M = $2.59B.
    • The hedge fund will pay Valeant ~$389M as part of their profit-sharing agreement so its ultimate take will be ~$2.2B.
    • Previously: It's official: Actavis buys Allergan
    | 8 Comments
  • Nov. 17, 2014, 10:13 AM
    • Valeant Pharmaceuticals (VRX +0.7%) Chairman and CEO Michael Pearson says his firm cannot justify paying the $219 (or more) per share for Allergan that Actavis (ACT +3.6%) has committed, although his team will review the agreement to determine a course of action.
    • He adds, "Our business is performing extremely well as evidenced by out third quarter results, our expected fourth quarter and our robust outlook for 2015. I am confident in our continued ability t generate exceptional shareholder value. We will remain focused on delivering strong organic results and evaluating acquisition opportunities as we always have: prudently, in a disciplined manner, and in the best interests of our shareholders."
    • Previously: It's official: Actavis buys Allergan
    | 2 Comments
  • Nov. 17, 2014, 9:26 AM
    • Actavis (NYSE:ACT) agrees to acquire Allergan (NYSE:AGN) for $66B or $219 per share. The transaction will be $129.22 in cash plus 0.3683 ACT shares for each AGN share.
    • AGN is up 5% premarket on robust volume. ACT is off a fraction on higher volume.
    | 2 Comments
  • Nov. 16, 2014, 3:51 PM
    • A deal could be announced as soon as Monday.
    • Allergan (NYSE:AGN) is trying to fend off a hostile bid by Valeant (NYSE:VRX), which has offered AGN about $54B in cash and stock, and has said it was prepared to raise its offer to $200/share.
    • Valeant, which has not been contacted by Allergan, would likely abandon its bid in the face of the Actavis (NYSE:ACT) deal.
    • The deal could include a $2B breakup fee that would need to be paid by Valeant were it to try and outbid Actavis.
    • Sources: Reuters, CNBC
    | 4 Comments
  • Nov. 13, 2014, 9:44 AM
    • The FDA accepts under Priority Review Actavis' (ACT +1.4%) Supplemental New Drug Application (sNDA) for Saphris (asenapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients ages 10 to 17.
    • Saphris' current label is the the treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, as monotherapy or as adjunctive therapy with either lithium or valproate.
    • The PDUFA date has not been specified but should be in Q1 2015.
    | Comment!
  • Nov. 12, 2014, 5:10 PM
    • Actavis (NYSE:ACT) appoints Maria Teresa Hilado CFO effective December 8, 2014 replacing R. Todd Joyce, who will remain with the company until early 2015 to assist in the transition. Ms. Hilado joins the firm from PepsiCo where she was SVP, Finance and Treasurer.
    | Comment!
  • Nov. 12, 2014, 12:22 PM
    • Allergan (AGN +0.7%) and Actavis (ACT -0.4%) are in advanced negotiations on a takeout bid for the Botox maker. According to people close to the matter, the price will be at least $200 per share or $60B. There remains a gap, though, in what Allergan is asking (~$210/share) and what Actavis wants to pay (~$200/share). Regardless, a deal seems likely in the next few weeks since the Valeant (VRX +0.9%)-instigated special shareholders meeting is December 18.
    • The potential transaction will most likely include ACT stock with cash.
    • Previously: Special shareholder meeting scheduled for Dec. 18
    | Comment!
  • Nov. 11, 2014, 4:16 PM
    • The presence of Pershing Square's Bill Ackman on the list of major investors in Zoetis (NYSE:ZTS) sends a clear signal that it may be an acquisition target by none other than Valeant Pharmaceuticals (NYSE:VRX). A deal is not out of the question in light of its diminishing prospects of acquiring Allergan (NYSE:AGN) since Actavis (NYSE:ACT) joined the mix.
    • In after hours trading, VRX is up a fraction and ZTS is unchanged, both on higher-than-normal volume.
    • Previously: Zoetis jumps 6% on report of Ackman stake
    | 1 Comment
  • Nov. 5, 2014, 7:26 AM
    • Actavis (NYSE:ACT) Q3 results ($M): Total Revenues: 3,683.1 (+83.0%), North America Brands: 1,619.3 (+999%), North America Generics and International: 1,613.2 (+5.6%), Anda Distribution: 423.2 (+37.8%); Gross Profit: 1,800.1 (+93.6%); Operating Expenses: 2,852.2 (+266.0%); Operating Loss: (1,052.1) (-799.1%); Net Loss: (1,042.8) (-999%); Quick Assets: 340.4 (+2.7%); CF Ops: 522.3 (+92.9%).
    • 2H 2014 Guidance: Total revenues: ~$7.4B from ~$7B; non-GAAP R&D expense: ~$650M; non-GAAP SG&A expense: ~$1.7B; non-GAAP tax rate: ~16%; non-GAAP EPS: $6.60 - 6.70 from $6.25 - 6.50..
    • 2014 Guidance: non-GAAP EPS: $13.51 - 13.61 from $13.02 - 13.32.
    • 2015 Guidance (from last quarter): Total revenues: ~$15B; non-GAAP EBITDA: $5.958B - 6.364B; non-GAAP EPS: $15.60 - 16.80. Guidance will be updated in early 2015.
    | Comment!
  • Nov. 5, 2014, 6:36 AM
    • Actavis (NYSE:ACT): Q3 EPS of $3.19 beats by $0.09.
    • Revenue of $3.68B (+83.1% Y/Y) beats by $50M.
    • Press Release
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Company Description
Actavis PLC specialty pharmaceutical company engaged in developing, manufacturing and distributing generic, brand and biosimilar products.
Sector: Healthcare
Industry: Drugs - Generic
Country: United States