Biotech Values

[DewDiligence]

AGN Reports 4Q09 Results

[This PR does not have product-specific sales (AGN will disclose those numbers on its CC today); however, it appears from this PR that Botox has not (yet) been strongly affected by the launch of the directly competing Reloxin/Dysport from MRX and Ipsen, respectively, insofar as full-year 2009 sales of Botox were roughly flat vs 2008 in dollars (rather than constant currencies). 52% of worldwide Botox sales in 2009 were for non-cosmetic indications.

It looks like Latisse (the eyelash-growing product that’s a repackaged version of the glaucoma drug, Lumigan—see #msg-34424441) will take longer to reach $500M in annual sales than I previously thought. AGN’s guidance for 2010 Latisse sales is $140M.]

http://sec.gov/Archives/edgar/data/850693/000119312510021487/dex991.htm

›IRVINE, Calif., February 4, 2010 — Allergan, Inc. (NYSE: AGN) today announced operating results for the quarter ended December 31, 2009. Allergan also announced that its Board of Directors has declared a fourth quarter dividend of $0.05 per share, payable on March 12, 2010 to stockholders of record on February 19, 2010.

Operating Results Attributable to Stockholders

For the quarter ended December 31, 2009:

• Allergan reported $0.72 diluted earnings per share attributable to stockholders compared to $0.48 diluted earnings per share attributable to stockholders reported for the fourth quarter of 2008.

• Allergan’s non-GAAP diluted earnings per share attributable to stockholders were $0.78 in the fourth quarter of 2009, compared to non-GAAP diluted earnings per share attributable to stockholders of $0.76 in the fourth quarter of 2008, a 2.6 percent increase.

Product Sales

For the quarter ended December 31, 2009:

• Allergan’s total product net sales were $1,206.5 million. Total product net sales increased 15.9 percent compared to total product net sales in the fourth quarter of 2008. On a constant currency basis, total product net sales increased 11.2 percent compared to total product net sales in the fourth quarter of 2008.

• Total specialty pharmaceuticals net sales increased 17.7 percent, or 13.1 percent on a constant currency basis, compared to total specialty pharmaceuticals net sales in the fourth quarter of 2008.

• Total medical devices net sales increased 8.3 percent, or 3.1 percent on a constant currency basis, compared to total medical devices net sales in the fourth quarter of 2008.

“The fourth quarter proved to be another strong quarter for Allergan as we benefited from the commercial investments made since mid-year and observed some recovery in our markets,” said David E.I. Pyott, Allergan’s Chairman of the Board and Chief Executive Officer. “In 2010 we look forward to rebuilding our cash-pay markets and to introducing some significant therapeutic innovations.”

Based on internal information and assumptions, full year 2009 therapeutic sales accounted for approximately 52% of total BOTOX® (onabotulinumtoxinA) sales and increased approximately 4% compared to 2008. Full year 2009 cosmetic sales accounted for approximately 48% of total BOTOX® sales and decreased approximately 4% compared to 2008.

Product and Pipeline Update

During the fourth 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® for certain therapeutic off-label treatments.

• 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® P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15% products infringe Allergan’s patents. Pursuant to the Hatch-Waxman Act, the U.S. Food and Drug Administration (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™ (dexamethasone intravitreal implant) 0.7 mg to treat non-infectious intermediate and posterior uveitis.

Following the end of the fourth quarter of 2009:

• On January 7, 2010, Allergan received marketing authorization from The European Commission for LUMIGAN® (bimatoprost ophthalmic solution) 0.01% which applies to the 27 countries of the European Union.

• On February 1, 2010, Allergan announced FDA approval of JUVÉDERM® XC dermal filler formulated with lidocaine to provide patients with enhanced comfort during treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds (or “parentheses”) that appear around the nose and mouth.

• Allergan completed its acquisition of Serica Technologies, Inc., a medical device company focused on the development of biodegradable silk-based scaffolds for use in tissue regeneration, including breast augmentation, revision and reconstruction and bariatric applications.

Outlook

For the full year of 2010, Allergan expects:

• Total product net sales between $4,550 million and $4,750 million.

• Total specialty pharmaceuticals net sales between $3,780 million and $3,930 million.

• Total medical devices net sales between $770 million and $820 million.

• ALPHAGAN® franchise product net sales between $320 million and $340 million.

• LUMIGAN® franchise product net sales between $520 million and $540 million.

• RESTASIS® product net sales between $580 million and $600 million.

• SANCTURA® franchise product net sales between $90 million and $100 million.

• BOTOX® product net sales between $1,330 million and $1,370 million.

• LATISSE® product net sales at approximately $140 million.

• Breast aesthetics product net sales between $290 million and $300 million.

• Obesity intervention product net sales between $250 million and $270 million.

• Facial aesthetics product net sales between $230 million and $250 million.

• Non-GAAP cost of sales to product net sales ratio between 16.0% and 16.5%.

• Other revenue at approximately $60 million.

• Non-GAAP selling, general and administrative expenses to product net sales ratio between 39% and 40%.

• 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 expectation excludes the amortization of acquired intangible assets associated with the Inamed, Cornéal, EndoArt, Esprit, Samil and Serica acquisitions and the ACZONE® asset purchase.

• Non-GAAP diluted earnings per share attributable to stockholders between $3.09 and $3.15.

• Diluted shares outstanding between approximately 307 million and 308 million.

• Effective tax rate on non-GAAP earnings between 28% and 29%.

For the first quarter of 2010, Allergan expects:

• Total product net sales between $1,060 million and $1,100 million.

• Non-GAAP diluted earnings per share attributable to stockholders between $0.57 and $0.59.

Expectations assume no passage of significant U.S. healthcare reform legislation including excise taxes or new rebates.‹