Collegium Reports Second Quarter Financial Results and Provides Corporate Update
- Net revenue
$73.1 millionfor the second quarter of 2018, 1,952% increase vs second quarter 2017, 15% vs first quarter 2018
- Xtampza ER prescriptions grew by 23% in the second quarter of 2018
- Cash balance at end of 2018 anticipated to be at least
- Conference call scheduled for today at
4:30 p.m. ET
“We made progress towards achieving our mission of becoming the leader in responsible pain management by developing and commercializing innovative and differentiated products for people suffering from pain and our communities,” said
“Through the first half of 2018 we continued to accelerate Xtampza ER and began to stabilize the Nucynta franchise,” said
Joe Ciaffoniappointed as Collegium’s CEO, effective July 1, 2018. Joe Ciaffonisucceeded Mike Heffernanas CEO, who continues to serve as Chairman of the Board of Directors.
- Executive management team strengthened with the promotion of
Scott Dreyerto the position of Executive Vice President and Chief Commercial Officer, effective July 10, 2018.
- Xtampza ER Total prescriptions were 80,364 in the second quarter of 2018, growing 23% over the first quarter of 2018.
- In the second quarter of 2018, total prescribers of Xtampza ER grew 11% to 9,228, including 2,756 new prescribers. Since launch, 13,542 health care providers have prescribed Xtampza ER.
- Continued to strengthen formulary access; Xtampza ER added to formulary at Cigna-Healthspring Medicare Part D on
April 1, 2018as the exclusive extended release oxycodone product for the majority of lives.
- The Nucynta franchise delivered 165,573 prescriptions in the second quarter, down 2% from the first quarter. Total prescriptions for Nucynta ER grew 1% in the second quarter.
- In the second quarter of 2018, two patents covering Xtampza ER were issued by the United States Patent and Trademark Office. Both patents were added to the FDA Orange Book, one with expiry in 2030 and the other with expiry in 2036. With the recent additions to the patent estate, Xtampza ER is now covered by 14 patents, including four patents with expiry in the 2030’s.
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 we will finish the year with at least
Conference Call Information
To access the conference call, please dial (888) 698-6931 (U.S.) or (805) 905-2993 (International) and refer to Conference ID: 126-8317. An audio webcast will be accessible from the Investor Relations section of the Company’s website: http://www.collegiumpharma.com/. An archived webcast will be available on the Company’s website approximately two hours after the event.
Collegium is a specialty pharmaceutical company focused on becoming the leader in responsible pain management by developing and commercializing innovative and differentiated products for people suffering from pain and our communities.
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.
Non-GAAP Financial Measures
To supplement our financial results presented on a U.S. generally accepted accounting principles, or GAAP, basis, we have included information about non-GAAP adjusted loss. We believe that the presentation of this non-GAAP financial measure, when viewed with our results under GAAP and the accompanying reconciliation, provides supplementary information that may be useful to analysts, investors, lenders, and other third parties in assessing the Company’s performance and results from period to period. We internally use non-GAAP adjusted loss to understand, manage and evaluate the Company as we believe it represents the performance of our core business. This non-GAAP financial measure should be considered in addition to, and not a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP. Non-GAAP adjusted loss is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude stock-based compensation expense, amortization expense for the Nucynta intangible asset, non-cash interest expense recognized on the Nucynta minimum royalty payments, and minimum royalty payments due and payable to
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 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 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; the rate and degree of market acceptance of our products; changing market conditions for our products; 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|
|Cash and cash equivalents||$||133,747||$||118,697|
|Prepaid expenses and other current assets||5,622||3,005|
|Property and equipment, net||3,203||1,826|
|Intangible assets, net||453,694||—|
|Other long-term assets||139||161|
|Accounts payable and accrued expenses||$||42,087||$||14,225|
|Accrued rebates, returns and discounts||107,790||15,784|
|Asset acquisition obligations||429,271||—|
|Total liabilities and stockholders’ equity||$||673,329||$||135,568|
|Collegium Pharmaceutical, Inc.|
|Unaudited Condensed Statements of Operations|
|(in thousands, except share and per share amounts)|
|Three months ended June 30,||Six months ended June 30,|
|Product revenues, net||$||73,061||$||3,560||$||136,810||$||5,732|
|Costs and expenses:|
|Cost of product revenues||46,838||577||89,944||948|
|Research and development||2,237||2,179||4,505||4,309|
|Selling, general and administrative||31,279||22,062||62,861||44,909|
|Total costs and expenses||80,354||24,818||157,310||50,166|
|Loss from operations||(7,293||)||(21,258||)||(20,500||)||(44,434||)|
|Loss per share–basic and diluted||(0.40||)||(0.72||)||(0.96||)||(1.50||)|
|Weighted-average shares -basic and diluted||32,967,718||29,441,514||32,935,873||29,396,143|
|Reconciliation of GAAP to Non-GAAP Financial Information|
|(in thousands, except per share amounts)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|GAAP net loss||$||(13,060||)||$||(21,121||)||$||(31,712||)||$||(44,199||)|
|Stock-based compensation expense||3,526||1,946||6,254||3,767|
|Nucynta related amortization expense (1)||32,407||-||61,933||-|
|Nucynta non-cash interest expense (2)||5,943||-||11,471||-|
|Nucynta minimum royalty payment due (3)||(33,750||)||-||(64,500||)||-|
|Total non-GAAP adjustments||$||8,126||$||1,946||$||15,158||$||3,767|
|Non-GAAP adjusted loss||$||(4,934||)||$||(19,175||)||$||(16,554||)||$||(40,432||)|
|First Quarter||Second Quarter|
|GAAP net loss||$||(18,652||)||$||(13,060||)|
|Stock-based compensation expense||2,728||3,526|
|Nucynta related amortization expense (1)||29,526||32,407|
|Nucynta non-cash interest expense (2)||5,528||5,943|
|Nucynta minimum royalty payment due (3)||(30,750||)||(33,750||)|
|Total non-GAAP adjustments||$||7,032||$||8,126|
|Non-GAAP adjusted loss||$||(11,620||)||$||(4,934||)|
|Explanation of Adjustments:|
|(1) Represents amortization expense of the Nucynta intangible asset.|
|(2) Represents non-cash interest expense recognized related to the Nucynta minimum royalty payments.|
|(3) Represents minimum royalty payment due and payable to Depomed in connection with the Commercialization Agreement.|