Full Press Release Details
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 4:30 p.m. ET -
STOUGHTON, Mass., Feb. 27,
2020 -- 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 fourth quarter and year ended December 31, 2019 and
provided a corporate update.
"In 2019 we delivered record
revenue and achieved non-GAAP profitability for three consecutive quarters," said Joe Ciaffoni, President and Chief Executive
Officer of Collegium. "Driven by Xtampza ER growth and the acquisition of the Nucynta Franchise, 2020 will be a financially
transformative year for Collegium."
Recent Business Highlights
Financial Guidance for 2020
The Company reiterates its full-year
2020 financial guidance, initially provided on January 7, 2020:
In addition, the Company provides
the following full-year 2020 financial guidance:
Financial Results for
Quarter Ended December 31, 2019
Full-Year 2019 Financial Highlights
Conference Call Information
The Company will host a conference
call and live audio webcast on Thursday, February 27, 2020 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: 829-8360. 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,
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 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.
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. 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 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 manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business
development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual
property protection for 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; our customer concentration; 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 Annual Report on Form 10-K for the year ended December 31, 2019 and
other filings 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.
Collegium Pharmaceutical, Inc.
Unaudited Selected Consolidated Balance
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Cash and cash equivalents | $ | 170,019 | $ | 146,633 | ||||
| Accounts receivable | 72,953 | 77,946 | ||||||
| Inventory | 9,643 | 7,817 | ||||||
| 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 | ||||||
| Total assets | $ | 306,302 | $ | 291,245 | ||||
| Accounts payable and accrued expenses | 39,727 | $ | 42,701 | |||||
| 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 | ||||||
| Stockholders' equity | 87,432 | 91,585 | ||||||
| Total liabilities and stockholders' equity | $ | 306,302 | $ | 291,245 |
Pharmaceutical, Inc.
Condensed Statements of Operations
except share and per share amounts)
| Three months ended December 31, | Years ended December 31, | |||||||||||||||
| 2019 | 2018 (1) | 2019 | 2018 | |||||||||||||
| Product revenues, net | $ | 74,203 | $ | 73,427 | $ | 296,701 | $ | 280,413 | ||||||||
| 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 | ) | |||||||||
| Interest expense | (211 | ) | (2,404 | ) | (909 | ) | (20,130 | ) | ||||||||
| Interest income | 383 | 489 | 1,935 | 1,687 | ||||||||||||
| Net loss | $ | (2,201 | ) | $ | 9,086 | $ | (22,722 | ) | $ | (39,128 | ) | |||||
| (Loss) Earnings per share - basic | $ | (0.07 | ) | $ | 0.27 | $ | (0.68 | ) | $ | (1.19 | ) | |||||
| Weighted-average shares - basic | 33,600,566 | 33,250,180 | 33,453,844 | 32,953,808 | ||||||||||||
| (Loss) Earnings per share - diluted | $ | (0.07 | ) | $ | 0.27 | $ | (0.68 | ) | $ | (1.19 | ) | |||||
| Weighted-average shares - diluted | 33,600,566 | 33,769,765 | 33,453,844 | 32,953,808 |
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 $15,494 in the fourth quarter compared to $32,407, $32,407 and $29,526 in the third, second and first quarters, respectively.