Biotech Values

[DewDiligence]

AGN Reports 2Q09 Results

[Botox, AGN’s most important product, held up well considering the soft economy and the fact that 50% of Botox sales are self-pay for a discretionary (cosmetic) use. Dysport, the competing neurotoxin from Ipsen and MRX, was launched in mid June—too late in the quarter to make a dent in Botox sales.

The next quarter’s numbers will tell the story as to whether Dysport will gain traction in the US market. Although Dysport has been available in some countries for about 20 years, Botox outsells Dysport worldwide by an astonishing 8:1 ratio. Please see actual PR for financial tables.]

http://finance.yahoo.com/news/Allergan-Reports-Second-bw-2710545217.html?x=0&.v=1

›Friday July 31, 2009, 9:00 am EDT

IRVINE, Calif.--(BUSINESS WIRE)--Allergan, Inc. (NYSE: AGN ) today announced operating results for the quarter ended June 30, 2009. Allergan also announced that its Board of Directors has declared a second quarter dividend of $0.05 per share, payable on September 7, 2009 to stockholders of record on August 17, 2009.

Operating Results Attributable to Stockholders

For the quarter ended June 30, 2009:

* Allergan reported $0.58 diluted earnings per share attributable to stockholders compared to $0.47 diluted earnings per share attributable to stockholders reported for the second quarter of 2008.

* Allergan’s non-GAAP diluted earnings per share attributable to stockholders were $0.75 in the second quarter of 2009, compared to non-GAAP diluted earnings per share attributable to stockholders of $0.63 in the second quarter of 2008, a 19.0 percent year-over-year increase.

Product Sales

For the quarter ended June 30, 2009:

* Allergan’s total product net sales were $1,118.7 million. Total product net sales decreased 3.2 percent as compared to total product net sales in the second quarter of 2008. On a constant currency basis, total product net sales increased 2.2 percent compared to total product net sales in the second quarter of 2008.

o Total specialty pharmaceuticals net sales decreased 0.6 percent as compared to total specialty pharmaceuticals net sales in the second quarter of 2008. On a constant currency basis, total specialty pharmaceuticals net sales increased 4.8 percent compared to total specialty pharmaceuticals net sales in the second quarter of 2008.

o Total medical devices net sales decreased 13.9 percent, or 8.5 percent on a constant currency basis, compared to total medical devices net sales in the second quarter of 2008.

“Our balanced portfolio of products, the contribution from recently launched products, disciplined execution of our operating plans and management’s attention to cost have all contributed to strong financial performance in the second quarter,” said David E.I. Pyott, Allergan’s Chairman of the Board and Chief Executive Officer. “Furthermore, we are excited by the recent FDA approval of OZURDEX™ (dexamethasone intravitreal implant) 0.7 mg and look forward to entering the rapidly growing retina market with the first FDA-approved drug treatment for macular edema following retinal vein occlusion.”

Product and Pipeline Update

During the second quarter of 2009:

* On April 15, 2009, Allergan received approval in Canada for LUMIGAN® (bimatoprost ophthalmic solution) 0.01% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

* On April 30, 2009, Allergan commented on the U.S. Food and Drug Administration’s (FDA) requested class labeling for botulinum toxin treatments.

* On May 26, 2009, Allergan announced that it received a complete response letter from the FDA regarding Allergan's Supplemental Biologics License Application (sBLA) for BOTOX® (Botulinum Toxin Type A) to treat upper limb spasticity.

* On June 18, 2009, Allergan announced that the FDA approved OZURDEX™ (dexamethasone intravitreal implant) 0.7 mg as the first drug therapy indicated for the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion.

* Allergan presented to the FDA the results from its two Phase III studies on the use of BOTOX® for the prophylactic treatment of headache in adults suffering from chronic migraine and completed an end-of-Phase III meeting and discussions with the FDA. Incorporating feedback from the FDA, Allergan intends to file its sBLA with the FDA for the use of BOTOX® in chronic migraine by the end of the third quarter of 2009.

Following the end of the second quarter of 2009:

* On July 7, 2009, Senju Pharmaceutical Co., Ltd received approval from the Japanese Ministry of Health, Labour and Welfare for LUMIGAN™ 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™ within the ophthalmic specialty area. Senju will pay Allergan a royalty based on LUMIGAN™ sales in Japan.

* On July 14, 2009, Allergan announced Korea Food and Drug Administration (KFDA) approval of LATISSE® (bimatoprost ophthalmic solution) 0.03%, a novel treatment for eyelash hypotrichosis or inadequate eyelashes. LATISSE® 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™ (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.

* A joint venture was created in Korea with Samil Pharmaceutical Co. Ltd. following decades of partnership to establish a leading position in ophthalmic pharmaceuticals.

Outlook

For the full year of 2009, Allergan estimates:

* Total product net sales between $4,200 million and $4,300 million.

o Total specialty pharmaceuticals net sales between $3,505 million and $3,560 million.

o Total medical devices net sales between $695 million and $740 million.

o ALPHAGAN® Franchise product net sales between $360 million and $380 million.

o LUMIGAN® Franchise product net sales between $430 million and $450 million.

o RESTASIS® product net sales between $490 million and $510 million.

o SANCTURA® Franchise product net sales at approximately $70 million.

o BOTOX® product net sales between $1,200 million and $1,220 million.

o LATISSE® product net sales at approximately $60 million.

o Breast aesthetics product net sales between $265 million and $280 million.

o Obesity intervention product net sales between $245 million and $260 million.

o Facial aesthetics product net sales between $185 million and $200 million.

* Non-GAAP cost of sales to product net sales ratio between 17.0% and 17.5%.

* Other revenue at approximately $60 million.

* Non-GAAP selling, general and administrative expenses to product net sales ratio at approximately 39%.

* Non-GAAP research and development expenses to product net sales ratio between 16% and 17%.

* 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® asset purchase.

* Non-GAAP diluted earnings per share attributable to stockholders guidance between $2.71 and $2.75.

* Diluted shares outstanding between approximately 304 million and 306 million.

* Effective tax rate on non-GAAP earnings at approximately 29%.

For the third quarter of 2009, Allergan estimates:

* Total product net sales between $1,050 million and $1,100 million.

* Non-GAAP diluted earnings per share attributable to stockholders guidance between $0.67 and $0.69.

…About Allergan, Inc.

Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential – to see more clearly, move more freely, express themselves more fully. The Company employs more than 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.‹