Allergan (AGN) Misses Q3 EPS Views; Offers Pipeline, FY16 Guidance Updates

November 2, 2016 6:37 AM EDT
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Allergan (NYSE: AGN) reported Q3 EPS of $3.32, $0.26 worse than the analyst estimate of $3.58. Revenue for the quarter came in at $3.62 billion versus the consensus estimate of $3.69 billion.

New Dividend and Stock Buyback:

Allergan (NYSE: AGN) initiated a quarterly dividend of $0.70 per share, or $2.8 annualized. Yield is currently 1.3 percent.

Allergan also entered into a variable tenor accelerated share repurchase program (ASR) under which the Company will repurchase $10 billion of its ordinary shares.

Pipeline Update

Allergan R&D continued to build and deliver on its pipeline in the quarter. Key development highlights included:

U.S. and International Branded Product Approvals and Launches

  • Allergan announced that BELKYRA® (deoxycholic acid) has received Marketing Authorization in Sweden after being granted approval by the Swedish Medical Products Agency (MPA). BELKYRA® was evaluated through a Decentralised Procedure, with the MPA acting as the Reference Member State and included 20 other countries in the European Union, as well as Iceland and Norway.
  • Allergan and Medicines360 announced the launch of the new LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg IUD single-handed inserter (intrauterine device), for use by women to prevent pregnancy for up to three years.
  • Allergan and Adams announced U.S. availability for four dosage strengths of NAMZARIC® (memantine and donepezil hydrochlorides) extended-release capsules that allow patients on donepezil 10 mg to start directly on NAMZARIC®.

Regulatory Milestones & Clinical Updates

  • Allergan announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a Positive Opinion for TRUBERZI® (eluxadoline) in the European Union. Allergan anticipates launching TRUBERZI® in Europe in 2017.
  • Allergan announced that FDA has accepted for filing the company's supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam), seeking the addition of new Phase 3 clinical trial data evaluating AVYCAZ® in patients with complicated urinary tract infections (cUTI), including pyelonephritis, due to designated susceptible pathogens to the current product label.
  • Allergan has initiated a Phase 3 study of rapastinel evaluating the efficacy, safety, and tolerability of rapastinel compared to placebo in patients with major depressive disorder (MDD).
  • Allergan has initiated a Phase 3 study of ubrogepant evaluating the efficacy, safety, and tolerability of ubrogepant compared to placebo for the acute treatment migraine.
  • Allergan has initiated a Phase 2 study of atogepant evaluating the safety and tolerability of various doses of atogepant for the prevention of episodic migraine.
  • Allergan and Serenity Pharmaceuticals announced that FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted in favor of the benefit risk profile of the New Drug Application (NDA) for SER120 (desmopressin nasal spray), an investigational drug developed for the treatment of nocturia, a common yet often under-diagnosed urological disorder, in adults who awaken two or more times per night to empty the bladder.
  • Allergan and Motus announced positive results from a Phase 2b study for relamorelin for the treatment of diabetic gastroparesis and other GI functional disorders. The study showed relamorelin administered for 12 weeks demonstrated substantial efficacy for the key diabetic gastroparesis symptoms of nausea, post-prandial fullness, abdominal pain and bloating (measured both individually and as a composite endpoint), along with a potent prokinetic effect on gastric motility. Allergan also announced that it has exercised its option to acquire Motus Therapeutics.


Allergan sees FY2016 EPS of $13.30-$13.50, versus the consensus of $13.94. Allergan sees FY2016 revenue of $14.45-14.65 billion, versus the consensus of $14.72 billion.

For earnings history and earnings-related data on Allergan (AGN) click here.

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