Collegium Reports Third Quarter Financial Results And Provides Corporate Update

  • Broadened Xtampza ER market access with commitments from large commercial payers
  • Submitted Supplemental New Drug Application to the FDA
  • Submitted New Drug Submission to Health Canada

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.

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