Collegium Reports First Quarter Financial Results and Provides Corporate Update
- Net revenue of
$63.7 million, compared to $10.8 millionin Q4 2017
- Xtampza ER prescriptions grew by 72% in the first quarter
- Integration of the Nucynta franchise into the commercial organization
- Conference call scheduled for today at
4:30 p.m. ET
“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
“In the first quarter of 2018, we were encouraged by the continued adoption of Xtampza ER by clinicians and payers,” said
- 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, 2018and 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.
- 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.
- Recently, we received an Issue Notification from the United States Patent and
Trademark Officefor 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
Net loss for the 2018 Quarter was
Research and development expenses were
Selling, general and administrative expenses were
Collegium had cash and cash equivalents of
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.
Conference Call Information
Collegium will host a conference call and live audio webcast on
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
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
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.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. Management’s expectations and, therefore, any forward-looking statements in this presentation could also be affected by risks and uncertainties relating to a number of other factors, including the following: our ability to obtain and maintain regulatory approval of our products and product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product; our plans to commercialize our product candidates and grow sales of our products; our ability to effectively commercialize in-licensed products and manage our relationships with licensors, including our ability to satisfy our royalty payment obligations in connection with such products; the size and growth potential of the markets for our products and product candidates, and our ability to service those markets; the success of competing products that are or become available; our ability to obtain and maintain reimbursement and third-party payor contracts for our products; the costs of commercialization activities, including marketing, sales and distribution; our ability to develop and maintain sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of our products and product candidates; changing market conditions for our products and product candidates; the outcome of any patent infringement or other litigation that may be brought by or against us, including litigation with
|Collegium Pharmaceutical, Inc.
Unaudited Selected Consolidated Balance Sheet Information
|March 31,||December 31,|
|Cash and cash equivalents||$||128,249||$||118,697|
|Prepaid expenses and other current assets||5,526||3,005|
|Property and equipment, net||1,612||1,826|
|Intangible assets, net||486,100||—|
|Other long-term assets||150||161|
|Accounts payable and accrued expenses||$||26,772||$||14,225|
|Accrued rebates, returns and discounts||92,400||15,784|
|Asset acquisition obligations||474,783||—|
|Total liabilities and stockholders’ equity||$||696,278||$||135,568|
|Collegium Pharmaceutical, Inc.
Unaudited Condensed Statements of Operations
(in thousands, except share and per share amounts)
|Three months ended March 31,|
|Product revenues, net||$||63,749||$||2,172|
|Costs and expenses:|
|Cost of product revenues||43,106||371|
|Research and development||2,268||2,130|
|Selling, general and administrative||31,582||22,847|
|Total costs and expenses||76,956||25,348|
|Loss from operations||(13,207||)||(23,176||)|
|Loss per share–basic and diluted||($||0.57||)||($||0.79||)|
|Weighted-average shares -basic and diluted||32,903,674||29,350,268|
Source: Collegium Pharmaceutical, Inc.