Endo International plc (NASDAQ: ENDP) (TSX: ENL) today reported second quarter 2014 revenues of $719 million, an increase of 1 percent compared to second quarter 2013 revenues of $712 million. Endo reported net income of $21 million in the second quarter 2014 compared to net income of $35 million in the second quarter of 2013. As detailed in the supplemental financial information below, adjusted net income for the three months ended June 30, 2014 increased by 4 percent to $174 million, compared to adjusted net income of $166 million for the second quarter of 2013.
Reported diluted EPS for the second quarter of 2014 was $0.13, compared to the second quarter 2013 reported earnings per share of $0.30. The decrease in reported diluted EPS is attributable to increased interest expense, a loss on extinguishment of debt, a smaller contribution from other income and an increase in the number of shares outstanding in the second quarter 2014.
Adjusted diluted EPS decreased by 25 percent to $1.06 for the second quarter of 2014 compared to $1.42 for the same period in 2013. The decrease in adjusted diluted EPS is primarily attributable to an increase in the number of shares outstanding. The increase in shares outstanding is attributable to additional Endo shares that were issued to exchange for the former shares of Paladin Labs as well as the dilutive effects of the company's 1.75% Convertible Notes and related warrants.
"Endo delivered strong performance across each of our business segments in the second quarter. We had organic growth in our core products, advanced our pipeline and supplemented our growth through strategic additions," said Rajiv De Silva, President and CEO of Endo. "As a result of our performance, we are raising financial guidance for full-year 2014. More importantly, our strong financial results support our continued pursuit of organic growth drivers, and strategic external growth opportunities where we see a clear case for value-creation for our shareholders. Over the past 12 months, we have made substantial progress towards our goal of becoming a leading specialty healthcare company and we are excited by the opportunities available to build upon this success."
FINANCIAL PERFORMANCE
U.S. BRANDED PHARMACEUTICALS
On July 7, Endo Pharmaceuticals Inc. announced positive top-line results from its pivotal Phase III efficacy study of BEMA® buprenorphine in opioid-experienced patients. Subsequently, the company participated in a pre-NDA meeting with representatives from FDA. Based on the discussion at that meeting, the company is planning on filing a New Drug Application (NDA) for BEMA buprenorphine by late 2014 or early 2015.
BEMA buprenorphine is being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in both patients who are opioid naïve and opioid experienced.
Second quarter 2014 branded pharmaceutical revenues were $249 million, a 40 percent decrease when compared to the second quarter 2013 branded pharmaceutical revenues. This decrease was primarily attributable to the decrease in net sales of LIDODERM®. Second quarter 2014 net sales of LIDODERM decreased 81 percent compared to the second quarter 2013. This decrease is attributable to the effects of the loss of market exclusivity for the product in September 2013. The decrease of LIDODERM sales in the second quarter was partially offset by $13 million of royalty revenues that Endo recognized per the terms of its previously announced Watson (now doing business as Actavis, Inc.) Settlement Agreement.
Second quarter 2014 net sales of Voltaren® Gel increased 7 percent when compared to second quarter 2013 net sales. This increase is attributable to growth in demand. According to IMS Health, total prescriptions for Voltaren Gel increased by 18 percent in the second quarter of 2014 when compared to the second quarter of 2013.
Second quarter 2014 net sales of OPANA® ER decreased 7 percent when compared to the second quarter 2013. This decrease is primarily attributable to a year-over-year decrease in demand. According to IMS Health, total prescriptions for OPANA ER decreased by 13 percent in the second quarter of 2014 when compared to the second quarter of 2013.
U.S. GENERIC PHARMACEUTICALS
On June 24, Endo announced that it reached a definitive agreement to acquire DAVA Pharmaceuticals, Inc., a privately-held company specializing in marketed, pre-launch and pipeline generic pharmaceuticals, for $575 million in cash, with additional cash consideration of up to $25 million contingent on the achievement of certain sales milestones. The acquisition enhances Endo's commercialization and development platform and is expected to be immediately accretive to Endo's 2014 adjusted earnings per share.
Second quarter 2014 generic product net sales of $272 million increased 60 percent when compared to second quarter 2013 generic product net sales. This increase is mainly attributable to the addition of sales from Boca Pharmacal following the close of that acquisition in February 2014 and sales of the Authorized Generic (AG) version of LIDODERM following the launch of that product by Qualitest in May 2014.
INTERNATIONAL PHARMACEUTICALS
On July 24, the company announced the completion of its acquisition of Grupo Farmaceutico Somar®, a leading, privately owned specialty pharmaceuticals company based in Mexico City. The combination of Somar and Endo further advances Endo's transformation into a leading global specialty healthcare company and establishes a platform for growth in key emerging markets in Latin America.
Endo will leverage its global resources along with Somar's proven commercial organization and scalable manufacturing facilities to take advantage of Somar's portfolio of current products and pipeline of over 60 new products that are expected to launch over the next three years.
Somar generated approximately $100 million of revenue in 2013 and has approximately 1,200 employees.
Second quarter 2014 sales of $72.1 million for the International Pharmaceuticals segment are attributable to the Paladin Labs business following the February 28th closing of the acquisition.
DEVICES
In the second quarter 2014, Endo reported device sales of $126 million compared to second quarter 2013 sales of $126 million. In the second quarter 2014, Men's Health sales increased 3 percent compared to the second quarter 2013. This increase is primarily attributable to increased sales of erectile restoration products.
In the second quarter 2014 Women's Health sales decreased by 5 percent compared to the same period last year. The decrease in Women's Health sales is attributable to year-over-year declines in U.S.-based procedural volumes.
Sales for AMS's benign prostatic hyperplasia (BPH) business decreased 3 percent in the second quarter of 2014 when compared to the second quarter of 2013. This decrease is primarily attributable to a decrease in GreenLight™ console sales and is partially offset by an increase of GreenLight fiber sales.
2014 Financial Guidance
Endo's estimates are based on projected results for the twelve months ended Dec. 31, 2014 and management's current belief about prescription and procedure trends, pricing levels, inventory levels and the anticipated timing of future product launches and events. The company's guidance for reported (GAAP) earnings per share does not include any estimates for potential new corporate development transactions. For the full twelve months ended Dec. 31, 2014, at current exchange rates, Endo estimates:
- Total revenue to be between $2.72 billion and $2.80 billion
- Reported (GAAP) diluted loss per share to be between $1.77 and $1.57
- Adjusted diluted earnings per share to be between $3.80 and $4.00
- Adjusted diluted earnings per share assume full year adjusted diluted shares outstanding of 157 million
The company's 2014 guidance is based on certain assumptions including:
- Adjusted gross margin of between 63 percent and 65 percent
- Year-over-year high-single digit percentage decrease of Adjusted Operating Expenses
- Adjusted interest expense of approximately $220 million
- Adjusted effective tax rate of between 23 percent and 24 percent
Balance Sheet Update
In June 2014 the company announced the placement of $750 million of 5.375% Senior Notes due 2023. Endo intends to use the net proceeds from the offering for general corporate purposes, which may include acquisitions, including the acquisition of DAVA Pharmaceuticals, Inc.
Conference Call Information
Endo will conduct a conference call with financial analysts to discuss this news release today at 8:30 a.m. ET. The dial-in number to access the call is U.S./Canada (877) 415-3179, International (857) 244-7322, and the passcode is 75265738. Please dial in 10 minutes prior to the scheduled start time.
A replay of the call will be available from July 31, 2014 at 11:00 a.m. ET until 11:59 p.m. ET on August 7, 2014 by dialing (888)-286-8010 (U.S./Canada) or (617)-801-6888 (international) and entering the passcode 13608816.
A simultaneous webcast of the call can be accessed by visiting www.endo.com. In addition, a replay of the webcast will be available until 11:59 p.m. ET on August 7, 2014. The replay can be accessed by clicking on "Events" in the Investor Relations section of the website.
New study aims to reduce bias in AI health prediction models