The FINANCIAL -- Allergan, Inc. (NYSE: AGN) on October 29 announced operating results for the quarter ended September 30, 2009. Allergan also announced that its Board of Directors has declared a third quarter dividend of $0.05 per share, payable on November 30, 2009 to stockholders of record on November 9, 2009.
Operating Results Attributable to Stockholders
For the quarter ended September 30, 2009:
Allergan reported $0.58 diluted earnings per share attributable to stockholders compared to $0.54 diluted earnings per share attributable to stockholders reported for the third quarter of 2008.
Allergan's non-GAAP diluted earnings per share attributable to stockholders were $0.70 in the third quarter of 2009, compared to non-GAAP diluted earnings per share attributable to stockholders of $0.65 in the third quarter of 2008, a 7.7 percent increase.
Product Sales
For the quarter ended September 30, 2009:
Allergan's total product net sales were $1,127.8 million. Total product net sales increased 4.2 percent compared to total product net sales in the third quarter of 2008. On a constant currency basis, total product net sales increased 7.0 percent compared to total product net sales in the third quarter of 2008.
Total specialty pharmaceuticals net sales increased 7.8 percent, or 10.7 percent on a constant currency basis, compared to total specialty pharmaceuticals net sales in the third quarter of 2008.
Total medical devices net sales decreased 10.6 percent, or 8.3 percent on a constant currency basis, compared to total medical devices net sales in the third quarter of 2008.
"We are pleased with our continued operational performance during the third quarter as our businesses are performing better than was expected at the beginning of 2009," said David E.I. Pyott, Allergan's Chairman of the Board and Chief Executive Officer. "With this strength in our businesses, we made the strategic decision to invest in increased Direct to Consumer advertising programs in the U.S. as we anticipate recovery from the recession. We are also pleased that we filed, with the U.S. Food and Drug Administration (FDA), BOTOX(R) (onabotulinumtoxinA) for chronic migraine as well as for upper limb spasticity."
Product and Pipeline Update
During the third quarter of 2009:
On July 7, 2009, a joint venture was created in Korea with Samil Pharmaceutical Co. Ltd. following decades of partnership to establish a leading position in ophthalmic pharmaceuticals.
On July 7, 2009, Senju Pharmaceutical Co., Ltd received approval from the Japanese Ministry of Health, Labour and Welfare for LUMIGAN(TM) Ophthalmic Solution 0.03% for the treatment of glaucoma or ocular hypertension. Allergan and Senju had previously entered into an exclusive licensing agreement in Japan to market and develop LUMIGAN(TM)within the ophthalmic specialty area. Senju will pay Allergan a royalty based on LUMIGAN(TM)sales in Japan.
On July 14, 2009, Allergan announced Korea Food and Drug Administration (KFDA) approval of LATISSE(R) (bimatoprost ophthalmic solution) 0.03%, a novel treatment for eyelash hypotrichosis, or inadequate eyelashes. LATISSE(R) is the first and only science-based treatment approved by the FDA and KFDA to enhance eyelash prominence as measured by increases in length, thickness and darkness of eyelashes.
On July 23, 2009, Allergan announced FDA approval of ACUVAIL(TM) (ketorolac tromethamine ophthalmic solution) 0.45%, an advanced, preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug indicated for the treatment of pain and inflammation following cataract surgery.
On September 15, 2009, a collaboration agreement with Pieris AG was announced that combines Pieris' proprietary Anticalin technology with Allergan's expertise in drug delivery and ophthalmic drug development with a goal of developing agents for the treatment of serious ocular disorders.
On September 25, 2009, Allergan and Quintiles Transnational Corp. announced an agreement under which Quintiles will co-promote Allergan's SANCTURA XR(R) (trospium chloride extended release capsules), an anticholinergic approved for the treatment of overactive bladder, predominantly to primary care physicians in the United States.
Allergan filed a supplemental Biologics License Application (sBLA) with the FDA for the use of BOTOX(R) (onabotulinumtoxinA) to treat chronic migraine.
Allergan submitted to the FDA the additional information requested by the FDA in its complete response letter regarding Allergan's sBLA for BOTOX(R) to treat upper limb spasticity.
Allergan filed a supplemental Premarket Approval application with the FDA for the LAP-BAND(R) System to treat weight reduction for severely obese adolescent patients (ages 14-17).
Following the end of the third quarter of 2009:
On October 1, 2009, Allergan filed a declaratory relief action in the United States District Court for the District of Columbia to seek a ruling that would allow the company to proactively share truthful and relevant information with the medical community regarding the safe use of BOTOX(R) for certain therapeutic off-label treatments.
On October 23, 2009, Allergan announced that the Committee for Medicinal Products for Human Use recommended granting a Marketing Authorization for LUMIGAN(R) (bimatoprost ophthalmic solution) 0.01% in the 27 member states of the European Union.
On October 23, 2009, Allergan announced that the United States District Court for the District of Delaware ruled in favor of Allergan, Inc. in its patent infringement suit against Exela PharmSci, Inc., Exela PharmSci Pvt., Ltd., Apotex, Inc. and Apotex Corp. (collectively, the "Defendants") finding that the patents are valid and enforceable against the Defendants and that the Defendants' proposed generic versions of Allergan's ALPHAGAN(R) P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15% products infringe Allergan's patents. Pursuant to the Hatch-Waxman Act, the FDA is required to delay approval of the Defendants' proposed generic products until after Allergan's last applicable patent expires in 2022.
Allergan filed a supplemental New Drug Application with the FDA for the approval of OZURDEX(TM) (dexamethasone intravitreal implant) 0.7 mg to treat non-infectious intermediate and posterior uveitis.
Outlook
For the full year of 2009, Allergan estimates:
Total product net sales between $4,350 million and $4,400 million.
Total specialty pharmaceuticals net sales between $3,635 million and $3,655 million.
Total medical devices net sales between $715 million and $745 million.
ALPHAGAN(R)franchise product net sales between $380 million and $390 million.
LUMIGAN(R)franchise product netsales between $450 million and $460 million.
RESTASIS(R) product netsales between $500 million and $510 million.
SANCTURA(R) franchise product netsales at approximately $70 million.
BOTOX(R) product netsales between $1,280 million and $1,290 million.
LATISSE(R) product netsales at approximately $70 million.
Breast aestheticsproduct netsales between $270 million and $280 million.
Obesity intervention product netsales between $245 million and $255 million.
Facial aesthetics product netsales between $200 million and $210 million.
Non-GAAP cost of sales to product net sales ratio between 16.5% and 17.0%.
Other revenue at approximately $60 million.
Non-GAAP selling, general and administrative expenses to product net sales ratio between 40% and 41%.
Non-GAAP research and development expenses to product net sales ratio between 15% and 16%.
Non-GAAP amortization of acquired intangible assets at approximately $20 million. This guidance excludes the amortization of acquired intangible assets associated with the Inamed, Cornéal, EndoArt, Esprit, and Samil acquisitions and the ACZONE(R) asset purchase.
Non-GAAP diluted earnings per share attributable to stockholders guidance between $2.75 and $2.77.
Diluted shares outstanding between approximately 304 million and 306 million.
Effective tax rate on non-GAAP earnings between 28% and 29%.
For the fourth quarter of 2009, Allergan estimates:
Total product net sales between $1,110 million and $1,160 million.
Non-GAAP diluted earnings per share attributable to stockholders guidance between $0.75 and $0.77.
On January 1, 2009, Allergan adopted the update to Financial Accounting Standards Board (FASB) guidance related to the accounting for convertible debt instruments that may be settled fully or partially in cash upon conversion, which requires retrospective application to prior periods. The impact from the adoption of this guidance on the previously reported GAAP results for the third quarter and first nine months of 2008 was a reduction of diluted earnings per share attributable to stockholders of $0.01 and $0.03, respectively, from the amounts previously reported. Non-GAAP diluted earnings per share attributable to stockholders for the third quarter and first nine months of 2008 were not impacted.
Historical non-GAAP basic and diluted earnings per share attributable to stockholders and guidance amounts for non-GAAP diluted earnings per share attributable to stockholders, non-GAAP cost of sales, non-GAAP selling, general and administrative expenses, non-GAAP research and development expenses, non-GAAP amortization of acquired intangible assets as well as non-GAAP net sales reported in constant currency are each reconciled to the most directly comparable GAAP financial measure in the financial tables of this press release and the accompanying footnotes. The reconciliation for the guidance amounts in the financial tables includes historical non-GAAP adjustments and an estimate of the future effect from amortization of acquired intangible assets and non-cash interest expense associated with amortization of convertible debt discount.
All prior period information in the financial tables of this press release has been retrospectively adjusted to reflect the impact of the adoptions in the first quarter of 2009 of updates to FASB guidance related to the accounting for convertible debt instruments that may be settled fully or partially in cash upon conversion and the accounting and financial reporting of noncontrolling ownership interests in subsidiaries held by parties other than the parent.
Related Stories
