Endo International plc (NASDAQ: ENDP) (TSX: ENL) today reported fourth quarter 2014 revenues of $800 million, an increase of 37 percent compared to fourth quarter 2013 revenues of $585 million, including new product revenue from 2014 strategic M&A transactions. Endo reported a fourth quarter 2014 net loss of $53 million compared to a fourth quarter 2013 net loss of $776 million.
As detailed in the supplemental financial information below, adjusted net income for the three months ended December 31, 2014 increased 49 percent to $185 million, compared to adjusted net income of $124 million for the fourth quarter of 2013.
Reported diluted loss per share for the fourth quarter of 2014 was $0.35, compared to the fourth quarter 2013 reported loss per share of $6.74. Adjusted diluted earnings per share increased 21 percent to $1.16 for the fourth quarter of 2014 compared to $0.96 for the same period in 2013.
"We are proud of the progress Endo made in rebuilding our business in 2014. This was achieved through multiple strategic transactions, a focus on organic growth and building our R&D pipeline. These efforts, along with the announcement that we will divest our AMS Men's Health and Prostate Health businesses, have helped us continue to transform the company into a leading global specialty pharmaceuticals company and, in the process, deliver strong financial performance," said Rajiv De Silva, President and CEO of Endo. "We look forward to continuing to invest in sustainable organic growth drivers in our existing commercial portfolio as well as our R&D pipeline and deploying capital to value-creating M&A. The sale of AMS increases our financial flexibility to support those objectives in our core pharmaceuticals businesses. We believe the recently closed acquisition of Auxilium Pharmaceuticals significantly expands the organic growth profile for our U.S. Branded Pharmaceuticals and more broadly supports a company objective to deliver high-single to low-double digit organic growth for revenues over the mid-term."
U.S. BRANDED PHARMACEUTICALS
On January 29, 2015 Endo announced that it had completed the acquisition of Auxilium Pharmaceuticals, Inc. The combined company is expected to provide an expanded platform to accelerate the evolution and growth of Endo's U.S. Branded Pharmaceuticals business. As a result of the acquisition, Endo's portfolio has a broader offering of urology and orthopedic products, including XIAFLEX®, TESTOPEL® and STENDRA®, which are natural complements to its men's health and pain products.
Fourth quarter 2014 U.S. branded pharmaceutical revenues were $246 million, a 3 percent decrease when compared to the fourth quarter 2013 U.S. branded pharmaceutical revenues. This decrease was primarily attributable to competition from Actavis' generic lidocaine patch.
Fourth quarter 2014 net sales of OPANA® ER decreased 13 percent when compared to the fourth quarter 2013. This decrease is primarily attributable to a year-over-year decrease in demand due to generic competition. According to IMS Health, total prescriptions for OPANA ER decreased by 11 percent in the fourth quarter of 2014 when compared to the fourth quarter of 2013.
Fourth quarter 2014 net sales of Voltaren® Gel increased 7 percent when compared to fourth quarter 2013 net sales. This increase is attributable to demand growth. According to IMS Health, total prescriptions for Voltaren Gel increased 12 percent in the fourth quarter 2014 when compared to the fourth quarter 2013.
U.S. GENERIC PHARMACEUTICALS
Fourth quarter 2014 U.S. generic product net sales of $337 million increased 70 percent when compared to fourth quarter 2013 U.S. generic product net sales. This increase is primarily attributable to the addition of sales from Boca Pharmacal and DAVA Pharmaceuticals following the close of those acquisitions in February 2014 and August 2014, respectively, and sales of the AG version of LIDODERM following the launch of that product by the U.S. Generics business in May 2014.
On November 20, 2014 Endo announced that its Qualitest subsidiary launched a generic version of Hoffmann-La Roche, Inc.'s Valcyte® (Valganciclovir Tablets USP, 450 mg). When launched, it was the first generic version of Valcyte available in the U.S. For the 12 months ending September 30, 2014, branded Valcyte had total U.S. sales of approximately $440 million, according to IMS Health data.
INTERNATIONAL PHARMACEUTICALS
In the fourth quarter 2014, the International Pharmaceuticals segment reported sales of $79.7 million which were attributable to the Paladin Labs business, acquired February 2014, and sales of products by Grupo Farmaceutico Somar, acquired July 2014.
DEVICES
In a separate press release today, Endo announced it has entered into a definitive agreement to sell its American Medical Systems' (AMS) Men's Health and Prostate Health businesses to Boston Scientific for up to $1.65 billion, with $1.6 billion in upfront cash. The transaction is expected to close in the third quarter of 2015. In addition, Endo is currently evaluating strategic alternatives for the AMS Women's Health business.
In the fourth quarter 2014, Endo reported device sales of $137 million compared to fourth quarter 2013 sales of $132 million. Full year 2014 sales for the Devices segment increased 1 percent compared to full year 2013 sales which met the company's previously stated expectation for a return to sales growth for the segment.
Sales for AMS' benign prostatic hyperplasia (BPH) products increased 14 percent in the fourth quarter of 2014 when compared to the fourth quarter of 2013. This increase is attributable to increased sales of GreenLight™ fiber and sales of StoneLight™ and Aura XP™ consoles.
In the fourth quarter 2014, worldwide Men's Health sales increased 2 percent compared to the fourth quarter 2013.
In the fourth quarter 2014 Women's Health sales decreased by 4 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.
2015 Financial Guidance
Endo's estimates are based on projected results for the twelve months ended December 31, 2015 and reflect management's current beliefs 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. The company's guidance assumes that results from AMS will be reported as Discontinued Operations.
For the full twelve months ended December 31, 2015, at current exchange rates, Endo estimates:
- Total revenue to be between $2.90 billion and $3.00 billion
- Reported (GAAP) diluted EPS from continuing operations to be between $2.73 and $2.93
- Adjusted diluted earnings per share from continuing operations to be between $4.35 and $4.55
- Adjusted diluted earnings per share assume full year adjusted diluted shares outstanding of 180 million
The company's 2015 guidance is based on certain assumptions including:
- Adjusted gross margin of between 63 percent and 65 percent
- Adjusted Operating Expenses as a percentage of revenues to be between 23 percent and 24 percent
- Adjusted interest expense of approximately $310 million
- Adjusted effective tax rate of between 15 percent and 17 percent
Balance Sheet Update
On January 21, 2015 the company announced that on January 20, 2015, Endo Limited, Endo Finance LLC and Endo Finco Inc., its wholly-owned subsidiaries, priced $1.2 billion aggregate principal amount of 6.00% senior notes due February 2025 at an issue price of $1,000 per $1,000 principal amount in connection with their previously announced private offering.
Endo used the net proceeds from the offering and cash on hand to finance its acquisition of Auxilium Pharmaceuticals, refinance certain indebtedness of Auxilium and pay related fees and expenses.
During 2014 AMS distributed $585 million of cash to Qualified Settlement Funds (QSF) related to settlement agreements that it reached by means of compromise to resolve vaginal mesh product liability claims. Cash distributions from QSF to plaintiffs' counsel following full release and dismissal of actions or claims were $111 million during 2014. The balance remaining in QSF as of December 31, 2014 was $485 million, which is shown as part of the total for restricted cash and cash equivalents on the Unaudited Condensed Consolidated Balance Sheet in this press release.
Conference Call Information
Endo will conduct a conference call with financial analysts to discuss this news release today at 8:30 a.m. ET.
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