Endo International Plc (NASDAQ:ENDP)

On 2/22/2010 we coded ENDP as a GeoBargain on the radar @ $22.10

On 2/28/2011 we added ENDP to the GeoBargain list @ $36.00

Catalyst: We first starting tracking the ENDP story on 2/22/2010 when the stock was trading at $22.10.  The company had just reported strong fiscal 2009 non-gaap EPS of $2.84 and issued 2010 non-gaap EPS of $3.15 to $3.20.  Continued strong quarterly results as well as the acquisition of AMS (a leading provider of world-class devices and therapies of male and female of pelvic health), lead us to believe the company still had room for growth. 

We are now removing ENDP from the GeoBargain List @ $37.68

Current road block:  Company issued non-gaap EPS guidance of $5.00 to $5.20, below analyst estimates of $5.45; 2013 analyst EPS estimates are calling for less then 10% growth.

Performance:

• Peak performance: Reached a high of  $44.53 on 04/11/2011 for a maiximum potential return of 24%
• Performance based on current price of $37.68: 5%

Fourth Quarter 2011 Results

• Total revenues during the fourth quarter of 2011 increased 57 percent to $803.4 million, compared with $511.2 million in the same quarter of 2010.
• Adjusted net income for the three months ended Dec. 31, 2011, was $168.2 million, up 32 percent, compared with $127.6 million in the same period in 2010.
• Adjusted diluted earnings per share for the same period were $1.40, up 32 percent from $1.06 reported in 2010.

"Endo has built a diversified platform of healthcare businesses that span branded pharmaceuticals, generics, medical devices and services, and our 2011 financial performance reinforces the execution of our growth strategy and evolution through acquisition, as well as the organic contributions and strengths of each of our business segments," said Dave Holveck, president and CEO of Endo. "We look forward to updating our investors on the sustainable growth story of our diversified business and how we are exploring new ways to deliver integrated solutions that create value for key constituencies."

2012 FINANCIAL GUIDANCE

Endo's estimates are based on projected results for the twelve months ended Dec. 31, 2012.  The company's guidance for reported (GAAP) earnings per share does not include any estimates for the potential future changes in the fair value of contingent consideration, certain separation benefits, asset impairment charges or for potential new corporate development transactions.  For the full year ended Dec. 31, 2012, Endo estimates:

• Total revenue between $3.15 billion and $3.30 billion 
• Total Branded Pharmaceuticals segment revenue between $1.740 billion and $1.800 billion
• Total Generics segment revenue between $635 million and $675 million 
• Total Devices segment revenue between $530 million and $570 million 
• Total Services segment revenue between $240 million and $260 million 
• Reported (GAAP) diluted earnings per share between $2.60 and $2.80 
• Adjusted diluted earnings per share between $5.00 and $5.20 
• Cash flow from operations between $750 million and $850 million 
• Capital expenditures to be approximately $100 million

RALEIGH, N.C. and CHADDS FORD, Pa., Feb. 16, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance of BDSI's patent application (No. 13/184306) that, once formally granted, will extend the exclusivity of the BioErodible MucoAdhesive (BEMA) drug delivery technology for BEMA Buprenorphine and BEMA Buprenorphine/Naloxone from 2020 to 2027. 

A Notice of Allowance is issued when the USPTO has determined to grant a patent.  Once the issue fee is paid, the final granting of the patent takes place, typically within a few months.

As a part of BDSI's recently signed BEMA Buprenorphine licensing and development agreement with Endo Pharmaceuticals (Nasdaq: ENDP), BDSI is entitled to a milestone payment in the amount of $15 million upon the final granting of this patent. 

"We are very pleased by the allowance of this patent application by the USPTO, that will not only provide non-dilutive capital to BDSI in the next couple months, but importantly extends the period of exclusivity, and thus the potential for a longer royalty stream, for BEMA Buprenorphine in its use for treating chronic pain following FDA approval and commercial launch," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "It is an added benefit that this patent upon granting will afford similar protection to BEMA Buprenorphine/Naloxone for the treatment of opioid dependence."

"Endo is committed to serving as an integrated solutions provider for the development and commercialization of products focused on the management of pain," said Dr. Ivan Gergel, M.D., executive vice president, R&D and chief scientific officer, Endo Pharmaceuticals. "And the allowance of the patent application is an exciting step in continuing Endo's tradition of novel product development in the field of pain management." 

BDSI expects the final granting of the patent and associated payment of the $15 million milestone within the next few months.

Third Quarter 2011 Results

• Total revenues during the third quarter of 2011 increased 71 percent to $759.1 million, compared with $444.1 million in the same quarter of 2010.
• Net income for the three months ended Sept. 30, 2011, was $40.6 million, compared with $54.2 million in the comparable 2010 period.
• Adjusted net income for the three months ended Sept. 30, 2011, was $151.1 million, up 50 percent compared with $100.8 million in the same period in 2010.
• Adjusted diluted earnings per share for the same period were $1.25, up 45 percent from $0.86 reported in 2010.

"Endo had another strong quarter, with record revenues and adjusted earnings, led by Opana ER, generics and AMS's Men's Health business," said Dave Holveck, president and CEO of Endo. "This performance is a testament to our diversified business model, and our commitment to enhancing healthcare delivery, which allows us to continue to bring together the aggregate capabilities of all our companies to create more solutions for patients, payors and physicians particularly across the entire urology spectrum."

2011 FINANCIAL GUIDANCE

Endo's estimates are based on actual results for the nine months ended Sept. 30, 2011. The company's guidance for reported (GAAP) earnings per share does not include any estimates for the potential future changes in the fair value of contingent consideration, certain separation benefits, any asset impairment charges or for potential new corporate development transactions. For the full year ended Dec. 31, 2011, Endo estimates:

• Total revenue between $2.72 billion and $2.80 billion
• Total Branded Pharmaceuticals segment revenue between $1.625 billion and $1.69 billion
• Total Generics segment revenue between $550 million and $575 million
• Total Device and Services segment revenue between $520 million and $550 million
• Reported (GAAP) diluted earnings per share between $1.87 and $1.97
• Adjusted diluted earnings per share between $4.55 and $4.65

Endo Pharmaceuticals (Nasdaq: ENDP) today reported financial results for the second quarter of 2011.

"Endo had a strong second quarter, with record revenues and earnings in our legacy branded pharmaceuticals pain franchise, which had double-digit revenue growth year-over-year," said Dave Holveck, president and CEO of Endo. "I remain very positive about the growth prospects of our new integrated business in branded pharmaceuticals, generics, and devices and services. I believe our strategy has positioned us well in the new healthcare environment to provide the right path to sustainable, long-term growth and to becoming one of our industry's premier providers of comprehensive healthcare solutions."

2011 Financial Guidance

Endo's estimates are based on actual results for the six months ended June 30, 2011 and management's current belief about prescription trends, pricing levels, inventory levels and the anticipated timing of future product launches and events. Our guidance takes into account that we closed our acquisition of American Medical Systems on June 17, 2011. The company's guidance for reported (GAAP) earnings per share does not include any estimates for the potential future changes in the fair value of contingent consideration or for potential new corporate development transactions. For the full year ended December 31, 2011 Endo estimates:

• Total revenue to be between $2.72 billion and $2.80 billion
• Total Branded Pharmaceuticals segment revenue to be between $1.625 billion and $1.69 billion
• Total Generics segment revenue to be between $550 million and $575 million
• Total Device and Services segment revenue to be between $520 million and $550 million
• Reported (GAAP) diluted earnings per share to be between $2.22 and $2.32
• Adjusted diluted earnings per share to be between $4.55 and $4.65

The company's 2011 guidance is based on certain assumptions including:

• Adjusted gross margin of between 69% and 71%
• Adjusted effective tax rate of approximately 28%
• Weighted average number of common shares outstanding of 123 million shares for the year ended December 31, 2011; and
• No generic competition for Voltaren Gel in 2011

HUNTSVILLE, Ala., June 24, 2011 /PRNewswire/ -- Qualitest Pharmaceuticals today issued a voluntary nationwide  retail level recall of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen  Tablets, USP 7.5mg/500mg. This recall was initiated because an individual bottle of Butalbital, Acetaminophen, and Caffeine Tablets USP, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen  Tablets, USP 7.5mg/500mg, 1000 count label, printed with Lot Number C0590909B.  Lots C0390909A, C0400909A, C0410909A used the same stock inventory of labels as Lot C0590909B and are potentially impacted.

Because the recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone (acetaminophen is in both preparations.) Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea. Additionally, patients with an allergy to butalbital could experience a hypersensitivity reaction.  Side effects due to caffeine are less likely, due to the small amounts in this formulation; however, those individuals with sensitivity to caffeine may experience symptoms such as tremors, irritability, and difficulty sleeping. Patients who were receiving hydrocodone for chronic pain might experience worsening pain and withdrawal symptoms as a result of this substitution.  No injuries have been reported to date.

The recall includes the following products:

Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B

This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

These lots were distributed between November 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).  Lot numbers can be found on the side of the manufacturer's bottle.  Butalbital, Acetaminophen, and Caffeine Tablets are (approximately 11.0 mm in diameter), white round-shaped tablets, debossed (2544) on one side, and debossed (V) on the reverse side; Hydrocodone Bitartrate and Acetaminophen Tablets are  (approximately 16.5  mm in length), white with green specs, round, capsule shaped, scored tablets, debossed (3594) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Hydrocodone Bitartrate and Acetaninophen manufactured by Qualitest, are asked to double check the identity of their tablets.

Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.

Consumers and patients with questions may contact Qualitest at 1-800-444-4011 for more information, Monday through Fridaybetween the hours of 8AM and 5PM CST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the manufacturer or to FDA's MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.

Online: www.fda.gov/medwatch/report.htm  

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

Reports of adverse reactions or quality problems can also be reported to Qualitest at

1-800-444-4011; Monday through Friday between the hours of 8AM and 5PM CST.

Jubilant Biosys Ltd., Bengaluru based subsidiary of Jubilant Life Sciences Ltd., and Endo Pharmaceuticals (Nasdaq: ENDP), of Chadds Ford, Pa, U.S.A., announced today that they have achieved a late stage discovery milestone in their joint program focused on cancer.

This is the third milestone in the two-year-old, multi-target, oncology focused partnership and enables the collaboration to rapidly pursue a development candidate. Endo and Jubilant had entered into a multiyear, multi-target oncology focused partnership in 2009. As a part of the partnership, Jubilant delivers preclinical development candidates and has an option to participate in clinical development. Endo owns the development and commercial rights to the successful outcomes. However, Jubilant derives research funding, development milestones and sales royalties on successful commercialization.

Commenting on this development, Sri Mosur, CEO& President, Global Drug Discovery & Development, Jubilant said: "We are pleased that we continue to enhance the portfolio outcomes for Endo Pharmaceuticals. It is an important achievement in our collaboration and demonstrates our scientist's commitment to Oncology research to deliver differentiated therapies to cancer patients worldwide. It will be our continued endeavor to support the collaboration in accelerating the development phase towards successful commercialization"

Sandeep Gupta, Sr. Vice President, Discovery and Early Development, Endo Pharmaceuticals commented: "We are pleased with the technical capabilities and productivity of the Jubilant team. They have done an outstanding job of designing novel molecules and to demonstrate preclinical proof of concept ahead of schedule. We look forward to nominating a development candidate in the near future."

Endo Pharmaceuticals today reported financial results for the first quarter 2011

"Endo had a terrific first quarter, with strong performance across every segment of our business," said Dave Holveck, president and CEO of Endo. "We continue our focus on creating sustainable long-term growth and look forward to delivering a strong performance in 2011."

Endo reiterated its standalone 2011 revenue guidance of between $2.35 to $2.45 billion and full year adjusted diluted earnings per share of between $4.20 to $4.30 per share.  Endo now estimates reported (GAAP) diluted earnings per share to be between $2.25 and $2.35 per share.

Endo Pharmaceuticals and American Medical Systems (AMS) announced today that they have entered into a definitive agreement under which Endo will acquire AMS, a leading provider of world-class devices and therapies for male and female pelvic health, for $30 per share, or $2.9 billion in cash, which includes the assumption and repayment of $312 million of AMS debt. The combined company will be positioned to deliver more comprehensive healthcare solutions across its diversified businesses in branded pharmaceuticals, generics and devices and services, in the key therapeutic areas of urology and pain.

AMS is a market leading provider of medical devices and therapies that help restore pelvic health, and is recognized as a technology leader for developing minimally invasive and more cost effective solutions, serving urologists, urogynecologists, and gynecologists. AMS' business consists of three segments: Men's Health, Women's Health and BPH (Benign Prostatic Hyperplasia) Therapy, with approximately 73 percent of its sales in the U.S. and the remainder coming from its international presence in Europe, Canada and the Asia Pacific and Latin America regions.

The acquisition will bring Endo scale in its devices and services business segment, and the combination of AMS with Endo's existing platform will provide additional cost-effective solutions across the entire urology spectrum. In addition, the acquisition will further Endo's diversification and increase revenue, earnings and cash flow streams. On a 2011 pro forma basis, the combined company, with approximately 4,000 employees, would have had revenues of approximately $3 billion and EBITDA of approximately $1 billion.