Collegium Reports Full-Year 2019 Revenue of $296.7 Million
– 2019 Revenue Growth of 6%, Driven by Xtampza ER revenue growth of 51% –
– Xtampza® ER Prescriptions Grew 49% in 2019 –
– Collegium Guides to Profitability in 2020 –
– Conference Call Scheduled for Today at
“In 2019 we delivered record revenue and achieved non-GAAP profitability for three consecutive quarters,” said
Recent Business Highlights
- Xtampza ER total prescriptions grew to 124,067 in the fourth quarter of 2019, representing a 37% increase over the fourth quarter of 2018. For the full year, total prescriptions for Xtampza ER grew 49%, reaching 466,378, compared to 313,152 total prescriptions in 2018.
- The Company secured 20 new exclusive ER oxycodone formulary wins covering more than 35 million lives for Xtampza ER, which took effect
January 1, 2020. With these wins, Collegium is the exclusive ER oxycodone for approximately 40% of Commercial and Part D covered lives. Xtampza ER continues to have broad-based coverage, including 95% coverage of Commercial lives and 50% coverage of Part D lives.
- The Company announced on
February 13, 2020it closed the acquisition of the U.S.rights to the Nucynta Franchise from Assertio Therapeutics, Inc.
Financial Guidance for 2020
The Company reiterates its full-year 2020 financial guidance, initially provided on
- Xtampza ER revenues are expected in the range of
$150.0 millionto $160.0 million.
- Nucynta Franchise revenues are expected in the range of
$170.0 millionto $180.0 million.
- Total operating expenses are expected in the range of
$130.0 millionto $140.0 million.
In addition, the Company provides the following full-year 2020 financial guidance:
- Non-GAAP adjusted income is expected in the range of
$125.0 millionto $140.0 million
Financial Results for Quarter Ended
- Xtampza ER net product revenues were
$27.4 millionfor the quarter ended December 31, 2019(the “2019 Quarter”), compared to $18.4 millionfor the quarter ended December 31, 2018(the “2018 Quarter”) and $26.5 millionfor the quarter ended September 30, 2019, representing an increase of 49% and 3%, respectively.
- Nucynta franchise net product revenues were
$46.8 millionin the 2019 Quarter, compared to $55.0 millionfor the 2018 Quarter and $46.5 millionfor the quarter ended September 30, 2019, representing a decrease of 15% and increase of 1%, respectively.
- Operating expenses were
$27.5 millionfor the 2019 Quarter, compared to $32.7 millionfor the 2018 Quarter.
- Net loss for the 2019 Quarter was
$2.2 million, or $0.07loss per share (basic and diluted), compared to net income of $9.1 million, or $0.27income per share (basic and diluted), for the 2018 Quarter. Net loss included stock-based compensation expense of $4.0 millionand $3.6 millionfor the 2019 Quarter and 2018 Quarter, respectively.
- Non-GAAP adjusted income for the 2019 Quarter was
$5.5 million, compared to a non-GAAP adjusted loss of $3.4 millionfor the 2018 Quarter.
Full-Year 2019 Financial Highlights
- For the year ended
December 31, 2019, total net product revenues were $296.7 million, which included Xtampza ER net revenues of $105.0 millionand Nucynta franchise net revenues of $191.7 million. This compared to total net product revenues of $280.4 millionfor the year ended December 31, 2018, which included Xtampza ER net revenues of $69.4 millionand Nucynta franchise net revenues of $211.0 million.
- Operating expenses for the year ended
December 31, 2019were $126.8 million, compared to $135.4 millionfor the year ended December 31, 2018. The decrease was primarily related to a decrease in sales, marketing and consulting costs of $8.1 million, primarily due to higher one-time costs incurred in 2018 to commercialize the Nucynta franchise.
- Net loss for the year ended
December 31, 2019was $22.7 million, or $0.68per share (basic and diluted), compared to a net loss of $39.1 million, or $1.19per share (basic and diluted) for the year ended December 31, 2018.
- Non-GAAP adjusted income for the year ended
December 31, 2019was $8.6 million. This compared to a non-GAAP adjusted loss of $28.2 millionfor the year ended December 31, 2018.
- The Company had cash and cash equivalents of
$170.0 millionat December 31, 2019,
Conference Call Information
The Company will host a conference call and live audio webcast on
Collegium is a specialty pharmaceutical company committed to being the leader in responsible pain management. Collegium’s headquarters are located in
Non-GAAP Financial Measures
To supplement our financial results presented on a GAAP basis, we have included information about non-GAAP adjusted income (loss). We use this non-GAAP financial measure to understand, manage and evaluate the Company as we believe it represents the performance of our core business. Because this non-GAAP financial measure is an important internal measure for the Company, we believe that the presentation of the non-GAAP financial measure provides analysts, investors and lenders insight into management’s view and assessment of the Company’s ongoing operating performance. In addition, 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 report this non-GAAP financial measure in order to portray the results of our major operations – commercializing innovative, differentiated products for people suffering from pain – prior to considering certain income statement elements. 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 income (loss) is not based on any standardized methodology prescribed by GAAP and represents GAAP net income (loss) adjusted to exclude stock-based compensation expense, amortization expense, non-cash interest expense, and minimum royalty payments due and payable in connection with the Nucynta Commercialization Agreement. Any non-GAAP financial measures used by us may be calculated differently from, and therefore may not be comparable to, a non-GAAP measure used by other companies. Please see the section of this press release titled “Reconciliation of GAAP to Non-GAAP Financial Information” for a reconciliation of non-GAAP adjusted loss to its most directly comparable GAAP measure.
The Company has not provided a reconciliation of its full-year 2020 guidance for non-GAAP adjusted income (loss) to the most directly comparable forward-looking GAAP measure because it is unable to predict, without unreasonable efforts, the timing and amount of items that would be included such a reconciliation. These items are uncertain and depend on various factors that could have a material impact on GAAP net income (loss) for the guidance period.
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," "forecasts," "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. Examples of forward-looking statements contained in this press release include, among others, statements regarding financial guidance for Xtampza ER and Nucynta Franchise revenues, total operating expenses, current and future market opportunities for our products and our assumptions related thereto. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including our expectations related to the potential impact of the Nucynta acquisition on our future operating results; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to obtain and maintain regulatory approval of our products and any product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product; the size of the markets for our products and product candidates, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products and product candidates; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement, opioid-related or other litigation that may be brought by or against us, including litigation with
Unaudited Selected Consolidated Balance Sheet Information
|Cash and cash equivalents|
|Prepaid expenses and other current assets||3,105||5,116|
|Property and equipment, net||11,854||9,274|
|Operating lease assets||9,047||—|
|Intangible assets, net||29,503||44,255|
|Other noncurrent assets||178||204|
|Accounts payable and accrued expenses||39,727|
|Accrued rebates, returns and discounts||157,549||144,783|
|Term loan payable||11,500||11,500|
|Operating lease liabilities||10,094||—|
|Other noncurrent liabilities||—||676|
|Total liabilities and stockholders’ equity|
Unaudited Condensed Statements of Operations
(in thousands, except share and per share amounts)
|Three months ended
|Product revenues, net|
|Costs and expenses:|
|Cost of product revenues||49,088||29,726||193,660||165,677|
|Research and development||2,398||2,249||10,340||8,661|
|Selling, general and administrative||25,090||30,451||116,449||126,760|
|Total costs and expenses||76,576||62,426||320,449||301,098|
|Loss from operations||(2,373)||11,001||(23,748)||(20,685)|
|(Loss) Earnings per share - basic|
|Weighted-average shares - basic||33,600,566||33,250,180||33,453,844||32,953,808|
|(Loss) Earnings per share - diluted|
|Weighted-average shares - diluted||33,600,566||33,769,765||33,453,844||32,953,808|
(1) - In the fourth quarter of 2018, the Company executed the Third Amendment to the Nucynta Commercialization Agreement, which eliminated the guaranteed minimum royalty payment obligations after 2018. As a result, the Company remeasured the remaining contractual obligation as of the Amendment Date and reduced the intangible asset. Consequently, amortization expense included within cost of product revenues was
|Reconciliation of GAAP to Non-GAAP Financial Information|
|(in thousands, except per share amounts)|
|Three months ended||Years ended|
|GAAP net income (loss)||$||(2,201)||$||9,086||$||(22,722)||$||(39,128)|
|Stock-based compensation expense||3,966||3,598||16,528||13,778|
|Nucynta related amortization expense (1)||3,688||15,494||14,752||109,834|
|Nucynta non-cash interest expense (2)||—||2,169||—||19,281|
|Nucynta minimum royalty payment due (3)||—||(33,750)||—||(132,000)|
|Total non-GAAP adjustments||$||7,654||$||(12,489)||$||31,280||$||10,893|
|Non-GAAP adjusted income (loss)||$||5,453||$||(3,403)||$||8,558||$||(28,235)|
|First Quarter||Second Quarter||Third Quarter||Fourth Quarter|
|GAAP net loss||$||(9,700)||$||(4,712)||$||(6,109)||$||(2,201)|
|Stock-based compensation expense||4,263||4,162||4,137||3,966|
|Nucynta related amortization expense (1)||3,688||3,688||3,688||3,688|
|Total non-GAAP adjustments||$||7,951||$||7,850||$||7,825||$||7,654|
|Non-GAAP adjusted income (loss)||$||(1,749)||$||3,138||$||1,716||$||5,453|
|First Quarter||Second Quarter||Third Quarter||Fourth Quarter|
|GAAP net income (loss)||$||(18,652)||$||(13,060)||$||(16,502)||$||9,086|
|Stock-based compensation expense||2,728||3,526||3,926||3,598|
|Nucynta related amortization expense (1)||29,526||32,407||32,407||15,494|
|Nucynta non-cash interest expense (2)||5,528||5,943||5,641||2,169|
|Nucynta minimum royalty payment due (3)||(30,750)||(33,750)||(33,750)||(33,750)|
|Total non-GAAP adjustments||$||7,032||$||8,126||$||8,224||$||(12,489)|
|Non-GAAP adjusted loss||$||(11,620)||$||(4,934)||$||(8,278)||$||(3,403)|
|(1) Represents amortization expense of the Nucynta Intangible Asset.|
|(2) Represents non-cash interest expense associated with the minimum royalty payments of the Nucynta Commercialization Agreement.|
|(3) Represents minimum royalty payment due and payable in connection with the Nucynta Commercialization Agreement.|
Source: Collegium Pharmaceutical, Inc.