(1) 2014E based on midpoint of guidance for revenue of $110-120 million and adjusted EBITDA of $22-24 million. 2015E based on guidance for revenue of $230 million and adjusted EBITDA of $95 million. Excludes transaction related expenses and non-cash items.
StudyStatusTimelines Treximet AdolescentsNDA submitted November 2014 Approximately 6 months Treximet Alternate Dose CRO agreements executed; Protocol in final stages of development Begin enrollment 2Q 2015 Silenor Arousability Study site selected; Protocol finalized Begin enrollment in January 2015 Silenor OTC program Protocol and strategy in development stage Request for FDA meeting 1Q 2015 Plan to file IND in 2015
Leverage Commercial Infrastructure Leverage 100-person specialty sales force US products/assets in complementary therapeutic areas Chronic vs. Acute Preference for chronic-use / refill products De-emphasis on acute / single-use products Patient Compliance Preference for compliant patient populations (e.g. women’s health) Direct pharmacy to improve patient contact and follow-up Pricing Power / Reimbursement Products that serve an unmet need Patient-types or products with price robustness Franchise Depth 505(b)2 and novel development programs with long exclusivities Driving towards innovation, late-stage development
(in millions)June 30, 2014September 30, 2014 Balance Sheet Cash$60.8$16.4 Debt$78.1$303.8 Capitalization Weighted Average Basic shares outstanding 37.838.2 Fully-diluted shares outstanding (1) 58.458.2 (1) Reflects diluted share count at the end of each period, including dilutive impact of convertible debt, in-the-money outstanding options and warrants, and non-vested restricted stock.
Large Market Opportunities Enhanced Promotion Managed Care & Pharmacy Initiatives Focus on Innovation 2013 triptan sales of $4.7 billion –Treximet has 2% share by volume Treximet pediatric sNDA submitted Nov 2014 –Migraine has 8% - 23% prevalence in children 11 or older 70 million adults in the U.S. affected by insomnia –Silenor has 0.2% share by volume Promotion-sensitive brands (Treximet, Silenor, Cedax) Expanded specialty sales force to cover 97% of business Re-launched Silenor in May 2014 Interim launch of Treximet in September 2014 –Full re-launch in 1Q 2015 Managed care initiatives to expand access to key brands and maintain unrestricted coverage –Maintained 140+ million coverage lives for Treximet with no material changes post-transition –Added 58+ million coverage lives for Silenor Pharmacy programs in place to prevent denials, rejections or switches Treximet pediatric sNDA submitted Other key studies to begin in 2015: –Treximet alternative dose –Silenor Arousability –Silenor OTC