– Xtampza® ER Net Product Revenues Were $26.0 Million in the Second Quarter of 2019, a 44% Increase Over the Second Quarter of 2018 –

– Cash and Cash Equivalents Increased to $148.7 Million as of June 30, 2019, From $134.9 Million as of March 31, 2019 –

– Net Loss Was $4.7 Million and Non-GAAP Net Income Was $3.1 Million in the Second Quarter of 2019 –

– Conference Call Scheduled for Today at 4:30 p.m. ET –

STOUGHTON, Mass., Aug. 07, 2019 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended June 30, 2019 and provided a corporate update. 

“We’re pleased to report that the growth trajectory for Xtampza® ER remained strong during the first half of 2019, with prescriptions growing 60% over the same period last year,” said Joe Ciaffoni, President and Chief Executive Officer of Collegium. “We remain committed to establishing Collegium as the leader in responsible pain management and making 2019 a breakthrough year for the Company.”

Recent Business Highlights

Financial Results for Quarter Ended June 30, 2019

Conference Call Information 

Collegium will host a conference call and live audio webcast on Wednesday, Aug. 7, 2019 at 4:30 p.m. Eastern Time. To access the conference call, please dial (888) 698-6931 (U.S.) or (805) 905-2993 (International) and refer to Conference ID: 309-8689. An audio webcast will be accessible from the Investors section of the Company’s website: www.collegiumpharma.com. The webcast will be available for replay on the Company’s website approximately two hours after the event.

About Collegium Pharmaceutical, Inc.

Collegium is a specialty pharmaceutical company committed to being the leader in responsible pain management. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the company’s website at www.collegiumpharma.com.

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.

Forward-Looking Statements

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 Purdue Pharma, L.P. and Teva Pharmaceuticals USA, Inc.; the outcome of any governmental investigation related to the manufacture, marketing and sale of opioid medications; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and product candidates and manufacture adequate supplies of our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency, or DEA, compliance; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, and in other reports which we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


Alex Dasalla
adasalla@collegiumpharma.com

 
Collegium Pharmaceutical, Inc.

Unaudited Selected Consolidated Balance Sheet Information
(in thousands)
 
 June 30, December 31,
  2019  2018
Cash and cash equivalents$148,713 $146,633
Accounts receivable 81,279  77,946
Inventory 9,953  7,817
Prepaid expenses and other current assets 4,618  5,116
Property and equipment, net 10,367  9,274
Operating lease assets 9,574  —
Intangible assets, net 36,879  44,255
Other noncurrent assets 198  204
Total assets$301,581 $291,245
    
Accounts payable and accrued expenses$35,458 $42,701
Accrued rebates, returns and discounts 158,264  144,783
Term loan payable 11,500  11,500
Operating lease liabilities 10,536  —
Other noncurrent liabilities —  676
Stockholders’ equity 85,823  91,585
Total liabilities and stockholders’ equity$301,581 $291,245


 
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,
 2019
 2018
 2019
 2018
Product revenues, net$75,040  $73,061  $149,556  $136,810 
                
Costs and expenses:               
Cost of product revenues 48,654   46,838   97,818   89,944 
Research and development 2,459   2,237   5,451   4,505 
Selling, general and administrative 28,935   31,279   61,287   62,861 
Total costs and expenses 80,048   80,354   164,556   157,310 
Loss from operations (5,008)  (7,293)  (15,000)  (20,500)
                
Interest expense (236)  (6,158)  (470)  (11,858)
Interest income 532   391   1,058   646 
Net loss$(4,712) $(13,060) $(14,412) $(31,712)
                
Loss per share–basic and diluted$(0.14) $(0.40) $(0.43) $(0.96)
Weighted-average shares -basic and diluted 33,397,709   32,967,718   33,338,243   32,935,873 



 
Reconciliation of GAAP to Non-GAAP Financial Information
(in thousands, except per share amounts)
(unaudited)
                
 Three Months Ended Six Months Ended
 June 30, June 30,
 2019
 2018
 2019
 2018
GAAP net loss$(4,712) $(13,060) $(14,412) $(31,712)
Non-GAAP adjustments:           
Stock-based compensation expense 4,162   3,526   8,425   6,254 
Nucynta related amortization expense (1) 3,688   32,407   7,376   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$7,850  $8,126  $15,801  $15,158 
Non-GAAP adjusted income (loss)$3,138  $(4,934) $1,389  $(16,554)
                
 First Quarter Second Quarter      
 2019  2019       
GAAP net loss$(9,700) $(4,712)      
Non-GAAP adjustments:           
Stock-based compensation expense 4,263   4,162       
Nucynta related amortization expense (1) 3,688   3,688       
Nucynta non-cash interest expense (2) —   —       
Nucynta minimum royalty payment due (3) —   —       
Total non-GAAP adjustments$7,951  $7,850       
Non-GAAP adjusted income (loss)$ (1,749) $ 3,138       


 First Quarter Second Quarter Third Quarter Fourth Quarter
 2018
 2018
 2018
 2018
GAAP net income (loss)$(18,652) $(13,060) $(16,502) $9,086 
Non-GAAP adjustments:           
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.