Collegium Provides Corporate Update

5/9/18

CANTON, Mass., May 09, 2018 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today reported its financial results for the first quarter of 2018 and provided a corporate update.

“Our significant growth in the first quarter is a step forward in our evolution to becoming a leader in responsible pain management as we strive to bring innovative treatment options to the pain market,” said Michael Heffernan, Chief Executive Officer of Collegium.

“In the first quarter of 2018, we were encouraged by the continued adoption of Xtampza ER by clinicians and payers,” said Joe Ciaffoni, Chief Operating Officer of Collegium. “As we integrate the Nucynta franchise into our product portfolio, we are committed to providing comprehensive pain management options to people suffering with pain.”

Recent Milestones

Commercial

  • Prescriptions for Xtampza ER grew to 65,367 in the first quarter of 2018, a 72% increase over the fourth quarter of 2017.
  • Prescribers of Xtampza ER grew to 10,786 since launch, including 3,886 new prescribers in the first quarter of 2018.
  • Continued to strengthen formulary access for Xtampza ER.
  • Made significant progress in Phase I of the Nucynta integration plan focused on transitioning and stabilizing the franchise. The transaction closed on January 9, 2018 and Collegium began promotion of the Nucynta franchise in mid-February 2018. All 5 strengths of Nucynta ER were available in late-March 2018, for the first time since the supply disruption in September 2017. As integration of the Nucynta franchise into the commercial organization continues, there are signs of stabilization.

Corporate

  • Strengthened leadership team with the addition of Shirley Kuhlmann, Executive Vice President and General Counsel and Secretary, with responsibility for our legal and compliance functions. Prior to joining Collegium, Ms. Kuhlmann was a Partner in the Health Sciences Department of Pepper Hamilton LLP, where she served as Collegium’s outside counsel.

Regulatory

  • Recently, we received an Issue Notification from the United States Patent and Trademark Office for a new patent covering Xtampza ER. Once issued, the new patent will be added to the FDA Orange Book and provides additional patent protection for Xtampza ER until 2036.

First Quarter 2018 Financial Results

Net Product Revenues were $63.7 million for the quarter ended March 31, 2018 (the “2018 Quarter”) compared to $2.2 million for the quarter ended March 31, 2017 (the “2017 Quarter”). In the 2018 Quarter, net product revenue was $15.8 million for Xtampza and $47.9 million for the Nucynta franchise.

Net loss for the 2018 Quarter was $18.7 million, or $0.57 per share (basic and diluted), as compared to net loss of $23.1 million, or $0.79 per share (basic and diluted), for the 2017 Quarter. Net loss includes stock-based compensation expense of $2.7 million and $1.8 million for the 2018 Quarter and 2017 Quarter, respectively. Net loss for the 2018 Quarter includes a non-cash interest charge of $5.5 million associated with accounting for Nucynta.

Research and development expenses were $2.3 million for the 2018 Quarter compared to $2.1 million for the 2017 Quarter. The increase was primarily related to clinical trial and regulatory activity.

Selling, general and administrative expenses were $31.6 million for the 2018 Quarter compared to $22.8 million for the 2017 Quarter. The increase was primarily related to higher personnel costs of $3.7 million and higher commercialization costs including consulting and marketing expenses of $3.0 million related to Nucynta.

Collegium had cash and cash equivalents of $128.2 million as of March 31, 2018, compared to $118.7 million as of December 31, 2017. Cash provided by operating and investing activities for the 2018 Quarter was $10.5 million.

As of March 31, 2018, there were 33,027,579 common shares outstanding.

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 ER and the Nucynta franchise will fund our operating expenses, debt service and capital expenditure requirements at least into 2020.

About Collegium Pharmaceutical, Inc.

Collegium is a specialty pharmaceutical company focused on becoming the leader in responsible pain management by developing and commercializing innovative, differentiated products for patients suffering from pain.

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.

About Nucynta ER

Nucynta® ER is an extended release formulation of tapentadol. Tapentadol is a centrally acting synthetic analgesic. Nucynta ER is 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. Nucynta ER is also approved by the FDA for neuropathic pain associated with diabetic peripheral neuropathy severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

About Nucynta

Nucynta® is an immediate release formulation of tapentadol indicated for the management of acute pain severe enough to require an opioid analgesic. Tapentadol is a centrally acting synthetic analgesic.

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