Collegium Reports Strong Q2 Results with Cash Balance Growing to Over $200 Million
– Xtampza® ER Market Share Grew to 31.5% of the Oxycodone Extended-Release Market in
– Net Income of
– Full-Year 2021 Product Revenue Guidance Updated –
– Conference Call Scheduled for Today at
“Collegium made meaningful progress against our corporate objectives in the second quarter, delivering strong financial results, driven by the underlying strength of our differentiated pain portfolio,” said
“In the second quarter, we generated significant cash flows and continued to leverage our cost structure,” said
Recent Business Highlights
Colleen Tupperwas appointed Executive Vice President and Chief Financial Officer, effective May 24, 2021.
- Xtampza ER was the fastest growing Branded ER product with prescriptions growing 6.9% over the first quarter of 2021 and 21.7% over the second quarter of 2020. Xtampza ER market share grew to 31.5% of the oxycodone extended-release market in June of 2021, up from 30.6% in
- Nucynta® Franchise prescriptions grew 0.5% over the first quarter of 2021. Nucynta ER Branded ER market share was stable compared to the first quarter of 2021.
- The Company sponsored a publication titled, “Nonmedical Use of Xtampza ER and Other Oxycodone Medications in Adults Evaluated for Substance Abuse Treatment: Real-world Data from the Addiction Severity Index – Multimedia Version (ASI-MV®),” published in the peer-reviewed medical journal,
Journal of Pain Research.
Financial Guidance for 2021
The Company updates its full-year 2021 financial guidance:
|Xtampza ER Revenues|
|Nucynta Franchise Revenues|
|Total Operating Expenses
(Including Stock-Based Compensation)
(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
$33.0 millionfor the quarter ended June 30, 2021(the “2021 Quarter”), compared to $33.6 millionfor the quarter ended June 30, 2020(the “2020 Quarter”).
- Nucynta franchise net product revenues were
$49.9 millionfor the 2021 Quarter, compared to $44.5 millionfor the 2020 quarter.
- Operating expenses, including stock-based compensation expense, were
$33.8 millionfor the 2021 Quarter, compared to $31.8 millionfor the 2020 quarter. Operating expenses, excluding stock-based compensation, were $27.3 millionfor the 2021 Quarter, compared to $26.2 millionfor the 2020 Quarter, demonstrating the Company’s continued commitment to leveraging its existing cost structure.
- Net income for the 2021 Quarter was
$72.8 million, or $2.06earnings per share (basic) and $1.79earnings per share (diluted), compared to net income of $8.1 million, or $0.23earnings per share (basic and diluted), for the 2020 quarter. Net income included stock-based compensation expense of $6.5 millionand $5.6 millionfor the 2021 Quarter and the 2020 Quarter, respectively. Net income for the 2021 Quarter also includes a one-time non-cash adjustment of $62.6 million, or $1.77per share (basic) and $1.52per share (diluted), due to the Company’s release of its tax valuation allowance on the majority of net operating losses and other deferred tax assets.
- Adjusted EBITDA for the 2021 Quarter was
$40.1 million, compared to $39.1 millionfor the 2020 Quarter.
Conference Call Information
The Company 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 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.
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
|Cash and cash equivalents||$||202,771||174,116|
|Accounts receivable, net||90,098||83,320|
|Prepaid expenses and other current assets||6,068||4,838|
|Property and equipment, net||19,555||18,988|
|Operating lease assets||8,023||8,391|
|Intangible asset, net||302,314||335,904|
|Deferred tax assets||62,649||—|
|Other noncurrent assets||115||123|
|Accounts payable and accrued expenses||34,929||34,672|
|Accrued rebates, returns and discounts||143,224||156,554|
|Term notes payable||133,863||157,514|
|Convertible senior notes||139,511||99,575|
|Operating lease liabilities||9,142||9,495|
|Total liabilities and stockholders’ equity||$||713,735||$||643,841|
Unaudited Condensed Statements of Operations
(in thousands, except share and per share amounts)
|Three months ended
||Six months ended
|Product revenues, net||$||82,942||$||78,058||$||170,663||$||154,569|
|Cost of product revenues|
|Cost of product revenues (excluding intangible asset amortization)||15,908||12,899||31,236||40,128|
|Intangible asset amortization||16,795||16,795||33,590||27,090|
|Total cost of products revenues||32,703||29,694||64,826||67,218|
|Research and development||3,462||2,493||6,392||5,159|
|Selling, general and administrative||30,368||29,322||61,844||60,582|
|Total operating expenses||33,830||31,815||68,236||65,741|
|Income from operations||16,409||16,549||37,601||21,610|
|Income before income taxes||10,991||8,304||26,465||8,754|
|(Benefit from) Provision for income taxes||(61,852||)||246||(62,040||)||246|
|Earnings per share — basic||$||2.06||$||0.23||$||2.52||$||0.25|
|Weighted-average shares — basic||35,302,608||34,395,266||35,128,144||34,247,977|
|Earnings per share — diluted||$||1.79||$||0.23||$||2.20||$||0.24|
|Weighted-average shares — diluted||41,286,853||35,091,906||41,251,749||35,089,740|
Reconciliation of GAAP Net Income to Adjusted EBITDA
|Three months ended
||Six months ended
|GAAP net income||$||72,843||$||8,058||$||88,505||$||8,508|
|(Benefit from) provision for income taxes||(61,852||)||246||(62,040||)||246|
|Stock-based compensation expense||6,516||5,584||13,395||10,535|
Reconciliation of GAAP Operating Expenses to Operating Expenses, Excluding Stock-Based Compensation
|Three months ended
||Six months ended
|GAAP Operating expenses||$||33,830||31,815||68,236||65,741|
|Operating expenses, excluding stock-based compensation||$||27,314||$||26,231||$||54,841||$||55,206|
Source: Collegium Pharmaceutical, Inc.