Collegium Reports Third Quarter Financial Results
- Net Product Revenues were
$70.2 million for the third quarter of 2018, a 487% increase versus third quarter of 2017 - Thirteen exclusive ER oxycodone formulary wins announced for Xtampza ER effective
January 1, 2019 - Cash increased by
$6.0 million , to$139.8 million as ofSeptember 30, 2018 ; raising year-end cash guidance to$145.0 million - Commercialization Agreement for Nucynta franchise amended to remove guaranteed annual minimum royalty and improves net cash flow for the transaction
- Conference call scheduled for today at
4:30 p.m. ET
“2018 has been a transformative year for Collegium,” said
Third Quarter and Business Highlights
- Xtampza ER total prescriptions were 86,944 in the third quarter of 2018. Through the first three quarters of 2018, prescriptions have grown 286% over the prior year period. Prescriptions grew 214% versus the prior year quarter, and 8% over the second quarter of 2018.
- Continue to strengthen formulary access; as of
January 1, 2019 , Xtampza ER will move into an exclusive ER oxycodone formulary position across 13 additional Commercial and Part D plans covering approximately 11 million lives. - Amendment to the Nucynta Commercialization Agreement removes the guaranteed annual minimum royalty of
$135.0 million and reduces Collegium’s royalty payments for the next three years. The amendment to the agreement is expected to significantly reduce liabilities on Collegium’s balance sheet and enables a tax efficient structure. - Nucynta franchise total prescriptions were 158,922 in the third quarter of 2018, down 4% from the second quarter of 2018. Prescriptions for Nucynta ER stabilized in the second and third quarters of 2018.
- Collegium established new corporate headquarters in
Stoughton, MA.
Third Quarter 2018 Financial Results
Net Product Revenues were
Net loss for the 2018 Quarter was
Selling, general and administrative expenses were
Collegium had cash and cash equivalents of
As of
Nucynta Transaction
On
Please refer to our 8-K filed with the
Financial Outlook
Based on our current operating plans, we expect to 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: 178-3678. 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.
About
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
About Nucynta
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 Depomed in connection with the 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,” “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; 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
Contact:
adasalla@collegiumpharma.com
Collegium Pharmaceutical, Inc. | |||
Unaudited Selected Consolidated Balance Sheet Information | |||
(in thousands) | |||
September 30, | December 31, | ||
2018 | 2017 | ||
Cash and cash equivalents | $139,790 | $118,697 | |
Accounts receivable | 66,533 | 9,969 | |
Inventory | 9,229 | 1,813 | |
Prepaid expenses and other current assets | 3,425 | 3,005 | |
Property and equipment, net | 6,039 | 1,826 | |
Intangible assets, net | 421,287 | — | |
Restricted cash | — | 97 | |
Other long-term assets | 205 | 161 | |
Total assets | $646,508 | $135,568 | |
Accounts payable and accrued expenses | $32,612 | $14,225 | |
Accrued rebates, returns and discounts | 130,454 | 15,784 | |
Asset acquisition obligations | 401,162 | — | |
Other liabilities | 11,500 | 1,479 | |
Stockholders’ equity | 70,780 | 104,080 | |
Total liabilities and stockholders’ equity | $646,508 | $135,568 | |
Collegium Pharmaceutical, Inc. | ||||||||||||
Unaudited Condensed Statements of Operations | ||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||
Three months ended September 30, | Nine months ended September 30, | |||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||
Product revenues, net | $70,176 | $11,950 | $206,986 | $17,682 | ||||||||
Costs and expenses: | ||||||||||||
Cost of product revenues | 46,007 | 553 | 135,951 | 1,501 | ||||||||
Research and development | 1,907 | 2,069 | 6,412 | 6,378 | ||||||||
Selling, general and administrative | 33,448 | 22,758 | 96,309 | 67,667 | ||||||||
Total costs and expenses | 81,362 | 25,380 | 238,672 | 75,546 | ||||||||
Loss from operations | (11,186) | (13,430) | (31,686) | (57,864) | ||||||||
Interest expense | (5,868) | — | (17,726) | — | ||||||||
Interest income | 552 | 167 | 1,198 | 402 | ||||||||
Net loss | $(16,502) | $(13,263) | $(48,214) | $(57,462) | ||||||||
Loss per share - basic and diluted | $(0.50) | $(0.45) | $(1.46) | $(1.95) | ||||||||
Weighted-average shares - basic and diluted | 33,012,174 | 29,753,043 | 32,950,854 | 29,517,396 | ||||||||
Reconciliation of GAAP to Non-GAAP Financial Information | |||||||||||
(in thousands, except per share amounts) | |||||||||||
(unaudited) | |||||||||||
Three Months Ended |
Nine Months Ended | ||||||||||
September 30, |
September 30, | ||||||||||
2018 | 2017 | 2018 |
2017 |
||||||||
GAAP net loss | $ | (16,502) | $ | (13,263) | $ | (48,214) | $ | (57,462) | |||
Non-GAAP adjustments: | |||||||||||
Stock-based compensation expense | 3,926 | 2,100 | 10,180 | 5,867 | |||||||
Nucynta related amortization expense (1) | 32,407 | - | 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 | $ | 8,224 | $ | 2,100 | $ | 23,382 | $ | 5,867 | |||
Non-GAAP adjusted loss | $ | (8,278) | $ | (11,163) | $ | (24,832) | $ | (51,595) | |||
Third Quarter | Second Quarter |
First Quarter |
|||||||||
2018 | 2018 |
2018 | |||||||||
GAAP net loss | $ | (16,502) | $ | (13,060) | $ | (18,652) | |||||
Non-GAAP adjustments: | |||||||||||
Stock-based compensation expense | 3,926 | 3,526 | 2,728 | ||||||||
Nucynta related amortization expense (1) | 32,407 | 32,407 | 29,526 | ||||||||
Nucynta non-cash interest expense (2) | 5,641 | 5,943 | 5,528 | ||||||||
Nucynta minimum royalty payment due (3) | (33,750) | (33,750) | (30,750) | ||||||||
Total non-GAAP adjustments | $ | 8,224 | $ | 8,126 | $ | 7,032 | |||||
Non-GAAP adjusted loss | $ | (8,278) | $ | (4,934) | $ | (11,620) | |||||
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 Assertio in connection with the Commercialization Agreement. |