Collegium Reports Third Quarter 2019 Financial Results
– New Exclusive Formulary Wins Announced for Xtampza® ER Effective
– Xtampza® ER Net Product Revenues Were
– Cash Increased by
– Conference Call Scheduled for Today at
“Driven by strong Xtampza ER revenue growth and a commitment to leveraging our existing cost structure, we are on track to make 2019 a breakthrough year for Collegium,” said
Recent Business Highlights
- Xtampza ER formulary access continues to strengthen: As of
January 1, 2020, Xtampza ER will move into an exclusive formulary position across 15 plans covering more than 35 million lives. With the addition of these new exclusive ER oxycodone formulary positions, Xtampza ER will be the exclusive branded ER oxycodone for more than 85 million lives.
- Xtampza ER total prescriptions grew to 120,409 in the third quarter of 2019. Through the first three quarters of 2019, prescriptions grew 44% over the prior year period, and 3% compared to the second quarter of 2019.
- Strengthened management team with the appointment of
Bart Dunnto the role of Executive Vice President, Strategy and Corporate Development.
Leading with the Science
- Collegium had a strong presence at the 13th Annual
PAINWeek National Conferencewhich took place in Las Vegasin September 2019. Four poster presentations that span Collegium’s product portfolio were presented during the conference.
- A manuscript about Nucynta ER titled, “Evaluation of Abuse and Route of
Administration of Extended-Release Tapentadol Among Treatment-Seeking Individuals, as Captured by the Addiction Severity Index–Multimedia Version (ASI-MV)” was recently published in the online journal Pain Medicine.
Financial Results for Quarter Ended
- Xtampza ER net product revenues were
$26.5 millionfor the quarter ended September 30, 2019(the “2019 Quarter”), compared to $17.0 millionfor the quarter ended September 30, 2018(the “2018 Quarter”) and $26.0 millionfor the quarter ended June 30, 2019, representing an increase of 56% and 2%, respectively.
- Nucynta franchise net product revenues were
$46.4 millionin the 2019 Quarter, compared to $53.1 millionfor the 2018 Quarter and $49.0 millionfor the quarter ended June 30, 2019, representing a decrease of 13% and 5%, respectively.
- Selling, general and administrative expenses were
$30.1 millionfor the 2019 Quarter, compared to $33.4 millionfor the 2018 Quarter.
- Net loss for the 2019 Quarter was
$6.1 million, or $0.18per share (basic and diluted), compared to net loss of $16.5 million, or $0.50per share (basic and diluted), for the 2018 Quarter. Net loss included stock-based compensation expense of $4.1 millionand $3.9 millionfor the 2019 Quarter and 2018 Quarter, respectively.
- Non-GAAP adjusted income for the 2019 Quarter was
$1.7 million, compared to a non-GAAP adjusted loss of $8.3 millionfor the 2018 Quarter.
- Collegium had cash and cash equivalents of
$153.8 millionas of September 30, 2019, an increase of $5.1 millioncompared to the second quarter of 2019. The increase in cash and cash equivalents was primarily the result of cash provided by operating activities, partially offset by capital expenditures related to the buildout of additional manufacturing capacity.
Conference Call Information
Collegium 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 internally 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. The Non-GAAP financial measure 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 for the Nucynta intangible asset, non-cash interest expense recognized on the Nucynta minimum royalty payments, 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.
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. 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 press release could also be affected by risks and uncertainties relating to a number of other factors, including our ability to obtain and maintain regulatory approval of our products and product candidates; our ability to effectively commercialize in-licensed products and manage our relationships with licensors; the success of competing products that are or become available; 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 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|
|September 30,||December 31,|
|Cash and cash equivalents||$||153,838||$||146,633|
|Prepaid expenses and other current assets||2,807||5,116|
|Property and equipment, net||11,579||9,274|
|Operating lease assets||9,219||—|
|Intangible assets, net||33,191||44,255|
|Other noncurrent assets||204||204|
|Accounts payable and accrued expenses||$||32,595||$||42,701|
|Accrued rebates, returns and discounts||165,263||144,783|
|Term loan payable||11,500||11,500|
|Operating lease liabilities||10,362||—|
|Other noncurrent liabilities||—||676|
|Total liabilities and stockholders’ equity||$||303,978||$||291,245|
Unaudited Condensed Statements of Operations
(in thousands, except share and per share amounts)
|Three months ended
|Nine months ended
|Product revenues, net||$||72,942||$||70,176||$||222,498||$||206,986|
|Costs and expenses:|
|Cost of product revenues||46,754||46,007||144,572||135,951|
|Research and development||2,491||1,907||7,942||6,412|
|Selling, general and administrative||30,072||33,448||91,359||96,309|
|Total costs and expenses||79,317||81,362||243,873||238,672|
|Loss from operations||(6,375||)||(11,186||)||(21,375||)||(31,686||)|
|Loss per share–basic and diluted||$||(0.18||)||$||(0.50||)||$||(0.62||)||$||(1.46||)|
|Weighted-average shares -basic and diluted||33,481,923||33,012,174||33,360,272||32,950,584|
|Reconciliation of GAAP to Non-GAAP Financial Information|
|(in thousands, except per share amounts)|
|Three Months Ended
||Nine Months Ended|
|GAAP net loss||$||(6,109||)||$||(16,502||)||$||(20,521||)||$||(48,214||)|
|Stock-based compensation expense||4,137||3,926||12,562||10,180|
|Nucynta related amortization expense (1)||3,688||32,407||11,064||94,340|
|Nucynta non-cash interest expense (2)||—||5,641||—||17,112|
|Nucynta minimum royalty payment due (3)||—||(33,750||)||—||(98,250||)|
|Total non-GAAP adjustments||$||7,825||$||8,224||$||23,626||$||23,382|
|Non-GAAP adjusted income (loss)||$||1,716||$||(8,278||)||$||3,105||$||(24,832||)|
||Second Quarter||Third Quarter|
|GAAP net loss||$||(9,700||)||$||(4,712||)||$||(6,109||)|
|Stock-based compensation expense||4,263||4,162||4,137|
|Nucynta related amortization expense (1)||3,688||3,688||3,688|
|Nucynta non-cash interest expense (2)||—||—||—|
|Nucynta minimum royalty payment due (3)||—||—||—|
|Total non-GAAP adjustments||$||7,951||$||7,850||$||7,825|
|Non-GAAP adjusted income (loss)||$||(1,749||)||$||3,138||$||1,716|
||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.