Collegium Reports Third Quarter Financial Results and Provides Corporate Update

11/11/16

CANTON, Mass., Nov. 10, 2016 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today reported its financial results for the third quarter of 2016 and provided a corporate update.

“It has been a very productive quarter for Collegium. We have made significant progress on the commercial launch of Xtampza® ER with broadened payer coverage, pharmacy availability, customer contracting, as well as increasing the physician prescriber base of the product,” stated Michael Heffernan, Collegium’s CEO. “Furthermore, we submitted a Supplemental New Drug Application to enhance the label for Xtampza ER and submitted a New Drug Submission to Health Canada seeking marketing approval for Xtampza ER in an important market outside of the U.S.”

Corporate Milestones

Commercial

  • UnitedHealth and Cigna announced availability for Xtampza ER for 15.6 million and 6.4 million contracted lives, respectively. Effective January 1, 2017, the UnitedHealth contract makes Xtampza ER a preferred product and the exclusive extended-release oxycodone product on its formulary with the removal of OxyContin from formulary.
  • In September 2016, Collegium announced the launch of OpioidIQ, an online educational tool to assist physicians and other healthcare providers with more effective pain management (available at www.OpioidIQ.com). The goal of OpioidIQ is to connect healthcare providers to information and resources aimed at supporting the safe and effective management of their patients with chronic pain who are appropriate for treatment with an opioid analgesic.
  • In October 2016, Collegium launched promotional material and marketing programs through its commercial organization after receiving feedback from the Office of Prescription Drug Promotion (OPDP) of the FDA.

Regulatory

  • In October 2016, Collegium announced the submission of a Supplemental New Drug Application (sNDA) to the FDA to enhance the label for Xtampza ER. The sNDA includes comparative oral pharmacokinetic data from two clinical studies evaluating the effect of physical manipulation by crushing Xtampza ER compared to crushing the abuse-deterrent version of OxyContin.
  • In October 2016, Collegium announced the submission of a New Drug Submission (NDS) to Health Canada seeking marketing approval of Xtampza ER. The NDS submission marks the first regulatory submission seeking to expand the geographic footprint of Xtampza ER in an important market outside of the U.S.

Publications

  • During the quarter, Collegium announced three scientific publications on Xtampza ER in The Journal of Clinical Pharmacology, The Journal of the American Medical Association (JAMA) and Current Medical Research and Opinion.

Corporate

  • In October 2016, Collegium announced a public offering of 5,000,000 shares of its common stock at a price of $16.00 per share. The gross proceeds of this offering were $80 million, excluding underwriters’ discounts and commissions and offering expenses payable by the Company.

Third Quarter 2016 Financial Results

As of September 30, 2016, prior to the financing described above, Collegium had cash and cash equivalents of $91.0 million compared to $95.7 million as of December 31, 2015. During the nine months ended September 30, 2016, cash and cash equivalents decreased by $4.7 million primarily due to cash used in operations of $51.8 million, cash utilized in the acquisition of rights to Onsolis® of $2.5 million and cash used to repay debt totaling $2.0 million, partially offset by the net proceeds of $51.2 million from our January 2016 follow-on offering of common stock.

Net loss for the quarter ended September 30, 2016 (the “2016 Quarter”) was $26.4 million, or $1.13 per share (basic and diluted), as compared to net loss of $9.4 million, or $0.46 per share (basic and diluted), for the quarter ended September 30, 2015 (the “2015 Quarter”). Net loss includes stock-based compensation expense of $1.6 million and $503,000 for the 2016 Quarter and 2015 Quarter, respectively.

Net product revenues for Xtampza ER were $408,000 for the 2016 Quarter compared to none for the 2015 Quarter.

Research and development expenses were $3.3 million for the 2016 Quarter compared to $3.4 million for the 2015 Quarter. The decrease was primarily related to a decrease in consulting costs of $956,000 related to the FDA advisory committee in 2015 and a decrease in manufacturing costs for Xtampza ER prior to FDA approval of $657,000, partially offset by an increase in clinical trial costs of $533,000 due to the initiation of clinical trials for Xtampza ER and Hydrocodone DETERx, an increase in manufacturing transfer costs related to Onsolis of $499,000 and an increase in personnel related costs of $369,000.

Selling, general and administrative expenses were $23.6 million for the 2016 Quarter compared to $5.9 million for the 2015 Quarter. The increase was primarily related to: an increase in personnel related costs of $8.8 million primarily due to an increase in headcount, an increase in Post Marketing Requirement costs required with FDA approval of Xtampza ER of $4.8 million, an increase in sales and marketing costs of $2.3 million primarily due to support for the commercial launch of Xtampza ER, and an increase in commercial costs of $1.2 million primarily due to consultant costs related to analytics and strategies for commercialization of Xtampza ER.

As of September 30, 2016, there were 23,588,985 common shares outstanding. As part of our follow-on offering subsequently completed in October 2016, we issued an additional 5,000,000 shares. In connection with the follow-on offering, the underwriters have the option to purchase an additional 750,000 shares within 30 days from the date of the final prospectus.

Financial Outlook

Based on our current operating plans, we believe that our existing cash resources, together with expected cash inflows from the commercialization of Xtampza as well as the proceeds of our follow-on offering completed in October 2016, will fund our operating expenses, debt service and capital expenditure requirements into 2019.

About Collegium Pharmaceutical, Inc.

Collegium is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its proprietary DETERx® technology platform for the treatment of chronic pain and other diseases. The DETERx technology platform is designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options.

About Xtampza ER

Xtampza® ER is Collegium’s first product utilizing the DETERx technology platform. Xtampza ER is an abuse-deterrent, extended-release, oral formulation of oxycodone approved by the FDA 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.