Close

Allergan, Inc. (AGN) Tops Q1 EPS by 5c; Guides FY14 EPS Above Views

May 7, 2014 9:01 AM EDT

(Updated - May 7, 2014 9:05 AM EDT)

Allergan, Inc. (NYSE: AGN) reported Q1 EPS of $1.18, $0.05 better than the analyst estimate of $1.13.

Product and Pipeline Update

During the first quarter of 2014:

  • On January 7, 2014, Allergan and Medytox, Inc. announced that they have closed the license agreement which was previously announced on September 25, 2013. Under the terms of the agreement, Allergan paid Medytox an upfront cash payment of U.S. $65 million and Medytox has granted Allergan exclusive rights, worldwide outside of Korea (and co-exclusive rights in Japan), to develop and, if approved, commercialize certain neurotoxin product candidates currently in development, including a potential liquid-injectable product. Pursuant to the agreement, Allergan has also agreed to make additional contingent payments, including up to an aggregate of U.S. $116.5 million upon achieving certain development milestones, up to an aggregate of U.S. $180.5 million upon achieving certain commercialization milestones, and royalties on product sales.
  • On January 14, 2014, the U.S. District Court for the Eastern District of Texas (District Court) ruled in favor of Allergan in a patent infringement matter concerning the Company’s LUMIGAN® (bimatoprost ophthalmic solution) 0.01% product. Allergan initiated the lawsuit under the Hatch-Waxman Act, after the defendants, Sandoz Inc., Lupin Ltd., Lupin Pharmaceuticals Inc., Hi-Tech Pharmacal Co., Inc., Watson Laboratories, Inc., Watson Pharmaceuticals, Inc., and Watson Pharma, Inc. (Defendants), sought to market a generic version of LUMIGAN® 0.01%, which was first approved by the FDA in 2010 for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The District Court found that all of the asserted claims of the 5 U.S. patents in the suit are not invalid and are infringed by Defendants’ proposed generic drug products. As part of the ruling, the District Court granted Allergan’s request for a permanent injunction enjoining the Defendants from marketing their proposed generic drug products until the expiration of the last of the LUMIGAN® 0.01% patents in 2027.
  • The U.S. Patent and Trademark Office has issued five patents which cover the specific formulation and the method of using Allergan’s RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% product. On the date each patent was granted, it was submitted for listing in the U.S. Food and Drug Administration’s (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. These patents expire August 27, 2024. There remains uncertainty as to the status of any abbreviated new drug application (ANDA) filers in respect to RESTASIS®. In addition, Allergan submitted a Citizen Petition to the FDA regarding the FDA’s published draft guidance that proposes certain approaches for demonstrating bioequivalence in an ANDA referring to the new drug application related to the RESTASIS® product.
  • The Japanese Ministry of Health, Labour and Welfare approved the Manufacturing and Marketing Application of GLASH VISTA® for the treatment for “hypotrichosis of the eyelashes”.
  • The Japanese Ministry of Health, Labour and Welfare approved the Marketing Application on hyaluronic acid-containing soft-tissue injectable material “JUVEDERM® Vista Ultra” and “JUVEDERM® Vista Ultra Plus” to correct moderate to severe facial wrinkles and folds such as nasolabial folds.

Following the end of the first quarter of 2014:

  • On April 22, 2014, Allergan confirmed receipt of an unsolicited proposal from Valeant Pharmaceuticals International, Inc. (Valeant) to acquire all of the outstanding shares of Allergan for a combination of 0.83 of Valeant common shares and $48.30 in cash per share of common stock of Allergan. The Allergan Board of Directors, in consultation with its financial and legal advisors, will carefully review and consider the Proposal and pursue the course of action that it believes is in the best interests of Allergan’s stockholders. Allergan also adopted a one-year Stockholder Rights Plan effective April 22, 2014.
  • Allergan announced that BOTOX® (Botulinum Toxin Type A) received a positive opinion from the Irish Medicines Board serving as reference member state in the mutual recognition procedure (MRP) for the treatment of focal spasticity of the ankle in adult post stroke patients. This is an important step towards securing national licenses in the 14 European countries involved in the MRP and marks a key milestone in bringing this treatment to stroke survivors across Europe who are suffering from lower limb spasticity.

The company sees FY14 sales of $6.775 to $7.0 billion and adjusted EPS of $5.64 to $5.73. The Street sees FY14 revs of $6.87 billion and EPS of $5.47.

For Q2, the company expects sales of $1.725 to $1.8 billion and EPS of $1.41 to $1.44. Consensus expectations call for Q2 revs of $1.74 billion and EPS of $1.37.

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



Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

Earnings, Guidance, Hot Earnings, Hot Guidance

Related Entities

Earnings, Definitive Agreement