Replies to post #81735 on 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.‹

[DewDiligence]

AGN:

Latisse sales did not improve much from last quarter…

Actually, Latisse sales did improve by a significant % from 1Q09 to 2Q09 when you adjust for the wholesale channel fill in 1Q09. The absolute numbers are still tiny, of course.

…but guidance for the year was raised.

The increase in 2009 guidance for Latisse (from $30-50M to $60M) is consistent with AGN’s M.O., which is to give very conservative product-specific guidance and subsequently raise it, perhaps several times.

By the way, one analyst proposed that AGN’s “male” version of Latisse for application to the scalp be called Matisse :- )

[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.‹

[DewDiligence]

Quiz: Why are Latisse sales relatively weak in New York, Massachusetts, and Texas?

[DewDiligence]

AGN’s 1Q10 Lastisse sales were surprisingly low; from the CC last week:

http://seekingalpha.com/article/202107-allergan-q1-2010-earnings-call-transcript?page=-1

[while] LATISSE sales soared by 52.6% [vs 1Q09], Q1 sales of $18.8 million were sequentially $7 million lower than in Q4. Some part of the decline is perhaps due to seasonality, as Q4 is the highest quarter of the year for BOTOX dermal fillers. At the margin, trade inventory was also in retrospect a little higher than our normally targeted level.

But perhaps most importantly, experienced LATISSE users are learning how to stretch out a bottle of product, which is good for the economics of the use but of course means that we have to recruit more users to attain the same value sales.

Reflecting back on the experience with the early years of BOTOX Cosmetic, we have probably brought on board the early adopters, but now need to expand into the mainstream. Clearly there's lots of potential, as doctors and consumers are pleased with the performance of the product. And we estimate today that only 20% to 25% of BOTOX Cosmetic users are buyers of LATISSE.

Our investment in DTC [direct-to-consumer marketing] will continue throughout the year. In order to stimulate demand for LATISSE from existing users of Allergan products, we are currently running a LATISSE anniversary offer with coupon which gives $50 off for BOTOX treatment and $50 off a treatment of JUVÉDERM for a total of $100 rebate with the purchase of LATISSE.

Notably, AGN did not lower the prior guidance of 2010 full-year Latisse sales of $140M. The long-term prospects for the product remain strong, IMO (#msg-47187268).

p.s. I’m curious to know how users are “learning how to stretch out a bottle of product” without sacrificing efficacy.