Allergan (AGN) Tops Q2 EPS by 1c

Allergan (NYSE: AGN) reported Q2 EPS of $4.41, $0.01 better than the analyst estimate of $4.40. Revenue for the quarter came in at $5.76 billion versus the consensus estimate of $5.71 billion.

Pipeline Update

Following the completion of the Allergan acquisition, the Brands Research & Development team has completed most of the pipeline prioritization, identifying key programs that will continue in development. Allergan now has more than 70 innovative products in mid-to-late stage development within seven therapeutic areas including biosimilars.

The Company plans to continue to evaluate timing of these opportunities and will provide additional details along with its third quarter earnings report on November 4th. R&D productivity continued during the quarter, with more than 100 approvals and 56 regulatory submissions for Branded projects worldwide in 2015. Key development highlights in the quarter included:

US and International Branded Product Approvals and Launches

• Viberzi™ (Eluxadoline) received Food and Drug Administration (FDA) approval for the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults. Allergan is awaiting Drug Enforcement Agency (DEA) scheduling of Viberzi®. In addition, Allergan submitted a dossier for approval of the product in the European Union in May 2015.
• NATRELLE® INSPIRA round gel-filled textured breast implants received FDA approval for women undergoing breast reconstruction, augmentation or revision surgery.
• NATRELLE® X and L Series silicone-filled breast implants received FDA approval, adding to a wide range of surgical options for physicians and patients across the Natrelle® 410 Shaped Gel Breast Implants line.
• Botox® received approval in Japan for the treatment of strabismus.
• Juvederm® received licensing rights for commercial sale of the product from the Chinese regulatory authority.
• NAMZARIC™ (memantine hydrochloride extended-release and donepezil hydrochloride), a once-daily, fixed-dose combination of memantine hydrochloride extended-release (a NMDA receptor antagonist), and donepezil hydrochloride (an acetylcholinesterase inhibitor), was launched in the United States.

Regulatory Submissions & Clinical Data

• Allergan announced that a New Drug Application (NDA) was submitted to the Japanese PMDA for Botox® for the treatment of crow's feet lines in adults aged 65 and over.
• Allergan initiated pivotal Phase III trials of DARPin® for the potential treatment of Age-related Macular Degeneration (AMD).
• Allergan announced presentation of data from its Alzheimer's disease portfolio at the 2015 Alzheimer's Association International Conference. Highlights included analyses on the use of memantine, extended-release memantine, and combination therapy with memantine and donepezil.

North American Generics and International

• Confirmed 12 first-to-file (FTF) opportunities year-to-date including generic versions of Uceris®, Letairis®, and Tyvaso®. Actavis' FTF performance continues to lead the industry.

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

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