COLLEGIUM PHARMACEUTICAL, INC. - Board of Directors Has Authorized
- Net Income of
- Full-Year 2021 Guidance Updated -
- Conference Call Scheduled for Today at
The Company also announced that its Board of Directors has authorized an accelerated share repurchase program to repurchase
“In the face of challenging market dynamics, Collegium is on track to achieve record full year revenue, net income, and adjusted EBITDA,” said
“In the third quarter, we generated significant net operating cash flows and continued to leverage our cost structure,” said
Business Highlights for Nine Months Ended
- The Company posted record total revenue, net income, and adjusted EBITDA through the first nine months of the year.
- Xtampza® ER achieved all-time highs in market share and exited Q3 2021 with 32.5% share of the ER oxycodone market, up 7.4 percentage points from year-end 2020.
- Nucynta® franchise net revenue grew to over
$150 million year-to-date, a level not seen in the first three quarters of a year since 2018. - Since the first quarter, the Company has sequentially reduced operating expenses, delivering on its commitment to leverage, not grow, its cost structure.
- The Company further strengthened its balance sheet; generated net operating cash flow; returned capital to shareholders through the repurchase of over 850,000 company shares under the share repurchase program announced in August; and, paid down
$37.5 million in debt year-to-date.
Financial Guidance for 2021
The Company updated its full-year 2021 financial guidance:
| Prior | Updated | |
| Xtampza ER Revenues | ||
| Nucynta Franchise Revenues | ||
| Total Operating Expenses (Including Stock-Based Compensation) | ||
| Adjusted EBITDA (Excluding Stock-Based Compensation) |
Collegium is not providing forward-looking guidance for its full-year 2021 U.S. GAAP net income (loss) or a quantitative reconciliation of forward-looking adjusted EBITDA. Please see “Non-GAAP Financial Measures” below for additional information.
Financial Results for Quarter Ended
- Xtampza ER net product revenues were
$30.0 million for the quarter endedSeptember 30, 2021 (the “2021 Quarter”), compared to$32.1 million for the quarter endedSeptember 30, 2020 (the “2020 Quarter”) as challenging market dynamics impacted the brand more than anticipated. - Nucynta franchise net product revenues were
$48.8 million for the 2021 Quarter, compared to$47.1 million for the 2020 quarter, as the franchise continued to benefit from the execution of the Company’s payer strategy and the continuity of care associated with COVID-19 dynamics. - Operating expenses, including stock-based compensation expense, were
$32.0 million for the 2021 Quarter, compared to$28.6 million for the 2020 quarter. Operating expenses, excluding stock-based compensation, were$26.0 million for the 2021 Quarter, compared to$23.4 million for the 2020 Quarter. - Net income for the 2021 Quarter was
$8.0 million , or$0.23 earnings per share (basic) and$0.22 earnings per share (diluted), compared to net income of$11.3 million , or$0.33 earnings per share (basic) and$0.32 earnings per share (diluted), for the 2020 Quarter. Net income included stock-based compensation expense of$5.9 million and$5.2 million for the 2021 Quarter and the 2020 Quarter, respectively. - Adjusted EBITDA for the 2021 Quarter was
$37.3 million , compared to$41.8 million for the 2020 Quarter. - The Company exited the 2021 Quarter with a net cash balance of
$193.2 million .
Conference Call Information
The Company will host a conference call and live audio webcast on
About
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 certain non-GAAP financial measures such as adjusted EBITDA and operating expenses, excluding stock-based compensation. We use these non-GAAP financial measures to understand, manage and evaluate our business as we believe they provide additional information on the performance of our business. We believe that the presentation of these non-GAAP financial measures, taken in conjunction with our results under GAAP, provide analysts, investors, lenders and other third parties insight into our view and assessment of our ongoing operating performance. In addition, we believe that the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provide supplementary information that may be useful to analysts, investors, lenders, and other third parties in assessing our performance and results from period to period. We report these non-GAAP financial measures to portray the results of our operations prior to considering certain income statement elements. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP.
Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, and stock-based compensation. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.
There are several limitations related to the use of adjusted EBITDA rather than net income, which is the nearest GAAP equivalent, such as:
- adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;
- we exclude stock-based compensation expense from adjusted EBITDA although (a) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy and (b) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position;
- adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs;
- adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; and
- adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments.
The Company has not provided a reconciliation of its full-year 2021 guidance for non-GAAP adjusted EBITDA 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 in such a reconciliation, including, but not limited to, stock-based compensation expense. These items are uncertain and depend on various factors that could have a material impact on GAAP net income for the guidance period.
Operating expenses, excluding stock-based compensation is a non-GAAP financial measure that represents GAAP operating expenses adjusted to exclude stock-based compensation expense.
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, Adjusted EBITDA, 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 the impact of the COVID-19 pandemic on our ability to conduct our business, reach our customers, and supply the market with our products; 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
(in thousands)
| 2021 | 2020 | |||||
| Cash and cash equivalents | $ | 193,241 | 174,116 | |||
| Accounts receivable, net | 148,999 | 83,320 | ||||
| Inventory | 17,358 | 15,614 | ||||
| Prepaid expenses and other current assets | 3,640 | 4,838 | ||||
| Property and equipment, net | 19,629 | 18,988 | ||||
| Operating lease assets | 7,835 | 8,391 | ||||
| Intangible asset, net | 285,518 | 335,904 | ||||
| Restricted cash | 2,547 | 2,547 | ||||
| Deferred tax assets | 63,026 | — | ||||
| Other noncurrent assets | 10 | 123 | ||||
| Total assets | $ | 741,803 | $ | 643,841 | ||
| Accounts payable and accrued expenses | 28,322 | 34,672 | ||||
| Accrued rebates, returns and discounts | 191,723 | 156,554 | ||||
| Term notes payable | 121,967 | 157,514 | ||||
| Convertible senior notes | 139,738 | 99,575 | ||||
| Operating lease liabilities | 8,959 | 9,495 | ||||
| Shareholders’ equity | 251,094 | 186,031 | ||||
| Total liabilities and stockholders’ equity | $ | 741,803 | $ | 643,841 | ||
Unaudited Condensed Statements of Operations
(in thousands, except share and per share amounts)
| Three months ended | Nine months ended | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Product revenues, net | $ | 78,843 | $ | 79,176 | $ | 249,506 | $ | 233,745 | |||||||
| Cost of product revenues | |||||||||||||||
| Cost of product revenues (excluding intangible asset amortization) | 15,934 | 14,188 | 47,170 | 54,316 | |||||||||||
| Intangible asset amortization | 16,796 | 16,795 | 50,386 | 43,885 | |||||||||||
| Total cost of products revenues | 32,730 | 30,983 | 97,556 | 98,201 | |||||||||||
| Gross profit | 46,113 | 48,193 | 151,950 | 135,544 | |||||||||||
| Operating expenses | |||||||||||||||
| Research and development | 1,450 | 2,141 | 7,842 | 7,300 | |||||||||||
| Selling, general and administrative | 30,514 | 26,426 | 92,358 | 87,008 | |||||||||||
| Total operating expenses | 31,964 | 28,567 | 100,200 | 94,308 | |||||||||||
| Income from operations | 14,149 | 19,626 | 51,750 | 41,236 | |||||||||||
| Interest expense | (5,115 | ) | (8,063 | ) | (16,257 | ) | (21,145 | ) | |||||||
| Interest income | 3 | 3 | 9 | 229 | |||||||||||
| Income before income taxes | 9,037 | 11,566 | 35,502 | 20,320 | |||||||||||
| (Benefit from) Provision for income taxes | 991 | 280 | (61,049 | ) | 526 | ||||||||||
| Net income | $ | 8,046 | $ | 11,286 | $ | 96,551 | $ | 19,794 | |||||||
| Earnings per share — basic | $ | 0.23 | $ | 0.33 | $ | 2.74 | $ | 0.58 | |||||||
| Weighted-average shares — basic | 35,373,909 | 34,540,126 | 35,210,966 | 34,346,071 | |||||||||||
| Earnings per share — diluted | $ | 0.22 | $ | 0.32 | $ | 2.42 | $ | 0.56 | |||||||
| Weighted-average shares — diluted | 36,261,174 | 35,069,188 | 41,274,190 | 35,054,777 | |||||||||||
Reconciliation of GAAP Net Income to Adjusted EBITDA
(in thousands)
(unaudited)
| Three months ended | Nine months ended | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| GAAP net income | $ | 8,046 | $ | 11,286 | $ | 96,551 | $ | 19,794 | |||||||
| Adjustments: | |||||||||||||||
| Interest expense | 5,115 | 8,063 | 16,257 | 21,145 | |||||||||||
| Interest income | (3 | ) | (3 | ) | (9 | ) | (229 | ) | |||||||
| Provision for (benefit from) income taxes | 991 | 280 | (61,049 | ) | 526 | ||||||||||
| Depreciation | 448 | 195 | 1,312 | 589 | |||||||||||
| Amortization | 16,796 | 16,795 | 50,386 | 43,885 | |||||||||||
| Stock-based compensation expense | 5,948 | 5,165 | 19,343 | 15,700 | |||||||||||
| Total adjustments | $ | 29,295 | $ | 30,495 | $ | 26,240 | $ | 81,616 | |||||||
| Adjusted EBITDA | $ | 37,341 | $ | 41,781 | $ | 122,791 | $ | 101,410 | |||||||
Reconciliation of GAAP Operating Expenses to Operating Expenses, Excluding Stock-Based Compensation
(in thousands)
(unaudited)
| Three months ended | Nine months ended | ||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||
| GAAP Operating expenses | $ | 31,964 | 28,567 | 100,200 | 94,308 | ||||||
| Stock-based compensation | 5,948 | 5,165 | 19,343 | 15,700 | |||||||
| Operating expenses, excluding stock-based compensation | $ | 26,016 | $ | 23,402 | $ | 80,857 | $ | 78,608 | |||
Contact:Sara Michelmore MacDougall Advisors smichelmore@macbiocom.com
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