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Ligand Reports Fourth Quarter and Full Year 2015 Financial ResultsLigand Pharmaceuticals Incorporated (NASDAQ: LGND) today reported financial results for the three and 12 months ended December 31, 2015, and provided an operating forecast and program updates. Financial highlights for the 2015 fourth quarter include:
A description of adjusted calculations and reconciliation to comparable GAAP financial measures is provided in the accompanying table titled "Adjusted Financial Measures." "2015 was a big year for Ligand financially, operationally and strategically. We posted our highest earnings ever which put us in a position to begin utilizing deferred tax assets that exceed $200 million. 2015 underlying product revenues for Promacta®, Kyprolis®, Conbriza™, Duavee® and Nexterone® were $1.1 billion, up 30% over 2014. We added to our portfolio over 40 shots on goal, or programs fully funded by partners and licensees. We saw numerous territory and label expansions for our two largest financial drivers, royalties on Promacta and Kyprolis, and announced positive clinical data on a novel diabetes drug we are developing. At the end of the year, we announced the acquisition of OMT, a strategic transaction that is expected to be immediately accretive, expands our technology offering and expands and extends our IP portfolio," said John Higgins, Chief Executive Officer of Ligand. "Ligand's business is very strong. We are forecasting growth in 2016 total revenues of approximately 60%, anticipate the approval and launch of potentially five new partnered products and expect to continue to build our portfolio of partnerships." Fourth Quarter 2015 Financial Results Total revenues for the fourth quarter of 2015 were $21.2 million, compared with $23.0 million for the same period in 2014. Royalty and milestone revenues were higher compared with the same period in the prior year, and Captisol® material sales were lower based on timing of supply purchases. Royalty revenues were $11.5 million, compared with $9.4 million for the same period in 2014 primarily due to higher royalties from Promacta and Kyprolis. Material sales were $7.2 million, compared with $13.0 million for the same period in 2014 due to timing of Captisol purchases for use in clinical trials and commercial products. Collaborative and other revenues were $2.4 million, compared with $0.6 million for the same period in 2014 due primarily to the timing of milestones and upfront license fees earned. Cost of goods sold was $0.9 million for the fourth quarter of 2015, compared with $4.0 million for the same period in 2014 due to the timing and mix of Captisol sales and lower cost of goods sold overall. Research and development expense was $2.9 million, compared with $3.2 million for the same period of 2014 as a result of timing of spending on internal development programs. General and administrative expense for the fourth quarter of 2015 was $6.2 million, compared with $5.6 million for the same period in 2014 due to costs associated with business development activities and non-cash stock-based compensation expense. Net income for the fourth quarter of 2015 was $6.3 million, or $0.29 per diluted share, compared with net income for the fourth quarter of 2014 of $7.1 million, or $0.34 per diluted share. Adjusted net income for the fourth quarter of 2015 was $14.3 million, or $0.66 per diluted share, compared with adjusted net income for the fourth quarter of 2014 of $12.5 million, or $0.60 per diluted share. As of December 31, 2015, Ligand had cash, cash equivalents and short-term and investments of $200.2 million. In January 2016 Ligand closed the acquisition of OMT for a purchase price of approximately $178 million, including $92.6 million in cash. Full Year 2015 Financial Results Total revenues for 2015 were $71.9 million, compared with $64.5 million in 2014. Royalty revenues were $38.2 million, compared with $30.0 million in 2014 primarily due to higher royalties from Promacta and Kyprolis. Material sales were $27.7 million, compared with $28.5 million in 2014 due to timing of customer purchases of Captisol for use in clinical trials and commercial products. Collaborative research and development and other revenues were $6.1 million in 2015 and 2014. Cost of goods sold was $5.8 million in 2015, compared with $9.1 million in 2014 due to the mix of Captisol sales and lower cost of goods sold overall. Research and development expense in 2015 was $13.4 million, compared with $12.1 million in 2014 due to timing of spending on internal development programs and non-cash stock-based compensation expense. General and administrative expenses in 2015 were $24.4 million, compared with $22.6 million in 2014 due to costs associated with business development activities, non-cash stock-based compensation expense other general business activities. Net income in 2015 was $257.3 million, or $12.12 per diluted share, compared with net income in 2014 of $12.0 million, or $0.56 per diluted share. The increase is primarily attributable to a net income tax benefit of $219.9 million, or $10.36 per diluted share, from the release of valuation allowance. Adjusted net income in 2015 was $71.6 million, or $3.37 per diluted share, compared with adjusted net income in 2014 of $32.6 million, or $1.52 per diluted share. Full Year and First Half 2016 Financial Forecast The Company expects 2016 total revenues to be between $114 million and $118 million, and adjusted earnings per diluted share to be between $3.37 and $3.42. This compares with previous guidance for total revenues to be between $113 million and $117 million for adjusted earnings per diluted share to be between $3.33 and $3.38. Ligand estimates that approximately 40% of its revenue and adjusted earnings will be booked in the first half of 2016. The adjusted earnings per diluted share guidance does not include changes in contingent liabilities, mark-to-market adjustment for amounts owed to licensors, non-cash stock-based compensation expense, non-cash debt-related costs, pro-rata non-cash net losses of Viking Therapeutics, non-cash OMT purchase price amortization and non-cash tax expense. Fourth Quarter 2015 and Recent Business Highlights Portfolio Program Progress Promacta/Revolade
Kyprolis® (carfilzomib), an Amgen Product utilizing Captisol
Additional Pipeline and Partner Developments
Acquisition
New Licensing Deals
Adjusted Financial Measures The adjusted financial measures discussed above and in the tables below for the three and 12 months ended December 31, 2015 and 2014 exclude stock-based compensation expense, non-cash debt-related costs, non-cash tax expense, changes in contingent liabilities, OMT purchase price amortization, non-cash pro-rata net losses of Viking Therapeutics, fair value adjustments to Viking Therapeutics convertible note receivable, mark-to-market adjustment for amounts owed to licensors and excess convert shares covered by bond hedge. Management has presented net income, net income per share, income from continuing operations and income from continuing operations per share in accordance with GAAP and on an adjusted basis. Ligand believes the presentation of adjusted financial measures provides useful supplementary information to investors and reflects amounts that are more closely aligned with the cash profits for the period as the items that are excluded from adjusted net income are all non-cash items. Ligand uses these adjusted financial measures in connection with its own budgeting and financial planning. These adjusted financial measures are in addition to, and not a substitute for, or superior to, measures of financial performance prepared in conformity with GAAP. Conference Call Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (877) 407-4019 from the U.S. or (201) 689-8337 from outside the U.S., using the passcode "Ligand." A replay of the call will be available until March 9, 2016 at 4:30 p.m. Eastern time by dialing (877) 660-6853 from the U.S. or (201) 612-7415 from outside the U.S., using passcode 13628528. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company with a business model focused on developing or acquiring royalty-generating assets and coupling them with a lean corporate cost structure. Ligand's goal is to produce a bottom line that supports a sustainably profitable business. By diversifying the portfolio of assets across numerous technology types, therapeutic areas, drug targets and industry partners, we offer investors an opportunity to invest in the increasingly complicated and unpredictable pharmaceutical industry. In comparison to our peers, we believe Ligand has assembled one of the largest and most diversified asset portfolios in the industry with the potential to generate revenue in the future. These therapies seek to address the unmet medical needs of patients for a broad spectrum of diseases including thrombocytopenia, multiple myeloma, hepatitis, ventricular fibrillation, muscle wasting, Alzheimer's disease, dyslipidemia, diabetes, anemia, asthma, focal segmental glomerulosclerosis, menopausal symptoms and osteoporosis. Ligand's Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly. Follow Ligand on Twitter @Ligand_LGND. Forward-Looking Statements This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as "plans," "believes," "expects," "anticipates," and "will," and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: Ligand's future revenue growth, Ligand's outlook for Captisol orders, the timing of the initiation or completion of clinical trials by Ligand and its partners, the timing of review of clinical data by the FDA, expected value creation for shareholders and guidance regarding first half and full-year 2016 financial results. Actual events or results may differ from Ligand's expectations. For example, Ligand may not receive expected revenue from material sales of Captisol, expected royalties on partnered products and research and development milestone payments. Ligand and its partners may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline. In addition, there can be no assurance that Ligand will achieve its guidance for 2016 or any portion thereof or beyond, that Ligand's 2016 revenues will be at the levels or be broken down as currently anticipated, that Ligand will be able to create future revenues and cash flows by developing innovative therapeutics, that results of any clinical study will be timely, favorable or confirmed by later studies, that products under development by Ligand or its partners will receive regulatory approval, that there will be a market for the product(s) if successfully developed and approved, or that Ligand's partners will not terminate any of its agreements or development or commercialization of any of its products. Further, Ligand may not generate expected revenues under its existing license agreements and may experience significant costs as the result of potential delays under its supply agreements. Also, Ligand and its partners may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Ligand's ability to obtain regulatory approval. Further, unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's product(s) could delay or prevent regulatory approval or commercialization. In addition, Ligand may not be able to successfully implement its strategic growth plan and continue the development of its proprietary programs. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Other Disclaimers and Trademarks The information in this press release regarding certain third-party products and programs, including Promacta, a Novartis product and Kyprolis, an Amgen product, comes from information publicly released by the owners of such products and programs. Ligand is not responsible for, and has no role in, the development of such products or programs. Ligand owns or has rights to trademarks and copyrights that it uses in connection with the operation of its business including its corporate name, logos and websites. Other trademarks and copyrights appearing in this press release are the property of their respective owners. The trademarks Ligand owns include Ligand®, Captisol® and OmniAb®. Solely for convenience, some of the trademarks and copyrights referred to in this press release are listed without the ®, © and ™ symbols, but Ligand will assert, to the fullest extent under applicable law, its rights to its trademarks and copyrights.
(1) The income tax benefit for the year ended December 31, 2015 includes a $2.1 million increase to the previously reported Q3 income tax benefit which increases basic and diluted earnings per share by $0.11 and $0.10, respectively.
(1) The income tax benefit for the year ended December 31, 2015 includes a $2.1 million increase to the previously reported Q3 income tax benefit which increases basic and diluted earnings per share by $0.11 and $0.10, respectively.
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