Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading,
diversified specialty pharmaceutical company, today announced
preliminary, unaudited financial results for the fourth quarter and
full year ended December 31, 2022.
“2022 was a pivotal year for Collegium
Pharmaceutical. We estimate fourth quarter and full year 2022 GAAP
operating expenses in the range of $38.4 million to $43.4 million
and in the range of $176.5 million to $181.5 million, respectively,
and we estimate fourth quarter and full year 2022 product revenues,
adjusted operating expenses and adjusted EBITDA at or above the
high-end of 2022 earnings guidance,” said Joe Ciaffoni, President
and Chief Executive Officer of Collegium. “We look forward to
providing full year 2022 results on our fourth quarter earnings
call.”
Fourth Quarter and Full Year 2022
Preliminary Results
- For the fiscal year ended December 31, 2022, we currently
estimate:
- Product revenues in the range of $460.0 million to $462.5
million;
- GAAP operating expenses in the range of $176.5 million to
$181.5 million and adjusted operating expenses in the range of
$122.0 million to $124.5 million; and
- Adjusted EBITDA in the range of $261.5 million to $264.0
million.
- For the fourth quarter ended December 31, 2022, we currently
estimate:
- Product revenues in the range of $125.7 million to $128.2
million,
- GAAP operating expenses in the range of $38.4 million to $43.4
million and adjusted operating expenses in the range of $32.3
million to $34.8 million, and
- Adjusted EBITDA in the range of $71.9 million to $74.4
million.
Preliminary 2022 Financial Results
The preliminary, unaudited financial results included in this
press release are based on information available as of February 6,
2023 and management's initial review of operations for the fourth
quarter and year ended December 31, 2022. They remain subject to
change based on management's ongoing review of the fourth-quarter
and full year results and are forward-looking statements. We assume
no obligation to update these statements. The actual results remain
subject to the completion of management’s and our audit committee’s
reviews and our other financial closing procedures, as well as the
completion of the preparation of our audited consolidated financial
results for the year ended December 31, 2022. During that
process, we may identify items that would require us to make
adjustments, which may be material, to the information presented in
this press release. While we do not expect that our actual results
for the year ended December 31, 2022 will vary materially from the
preliminary, unaudited financial results presented in this press
release, there can be no assurance that these estimates will be
realized. Actual results may be materially different and are
affected by the risk factors and uncertainties identified in this
press release and in our annual and quarterly filings with the
Securities and Exchange Commission (“SEC”).
These preliminary, unaudited results should be read in
conjunction with “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and our consolidated financial
statements and the related notes thereto included in our Annual
Report on Form 10-K for the year ended December 31,
2021 and our Quarterly Report on Form 10-Q for the period
ended September 30, 2022, which have been filed with the SEC.
The preliminary, unaudited financial information presented herein
should not be considered a substitute for the financial information
to be filed with the SEC in our Annual Report on
Form 10-K for the year ended December 31, 2022 once
it becomes available.
Non-GAAP Financial Measures
We have included information about certain non-GAAP financial
measures in this press release. 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, where applicable,
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.
In this press release we discuss the following financial
measures that are not calculated in accordance with GAAP.
Adjusted EBITDA
Adjusted EBITDA is a non-GAAP financial measure that represents
GAAP net income (loss) adjusted to exclude interest expense,
interest income, the benefit from or provision for income taxes,
depreciation, amortization, stock-based compensation, and other
adjustments to reflect changes that occur in our business but do
not represent ongoing operations. 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 (loss), 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;
- adjusted EBITDA does not reflect historical cash expenditures
or future requirements for capital expenditures or contractual
commitments;
- we exclude impairment expenses from adjusted EBITDA and,
although these are non-cash expenses, the asset being impaired may
have to be replaced in the future, the cash requirements for which
are not reflected in adjusted EBITDA;
- we exclude restructuring expenses from adjusted EBITDA.
Restructuring expenses primarily include employee severance and
contract termination costs that are not related to acquisitions.
The amount and/or frequency of these restructuring expenses are not
part of our underlying business;
- we exclude litigation settlements from adjusted EBITDA, as well
as any applicable income items or credit adjustments due to
subsequent changes in estimates. This does not include our legal
fees to defend claims, which are expensed as incurred;
- we exclude acquisition related expenses as the amount and/or
frequency of these expenses are not part of our underlying
business. Acquisition related expenses include transaction costs,
which primarily consisted of financial advisory, banking, legal,
and regulatory fees, and other consulting fees, incurred to
complete the acquisition, employee-related expenses (severance cost
and benefits) for terminated employees after the acquisition, and
miscellaneous other acquisition expenses incurred; and
- we exclude recognition of the step-up basis in inventory from
acquisitions (i.e., the adjustment to record inventory from
historic cost to fair value at acquisition) as the adjustment does
not reflect the ongoing expense associated with sale of our
products as part of our underlying business.
Because we have not yet completed our year-end closing
process and because of the forward-looking nature of the estimated
adjusted EBITDA ranges presented above for the fourth quarter and
year ended December 31, 2022, we do not have specific
quantifications of the amounts that would be required to provide a
reconciliation of net income (loss), the most directly comparable
financial measure calculated and presented in accordance with GAAP
to adjusted EBITDA for the fourth quarter and year ended
December 31, 2022. We believe that there is a degree of
variability with respect to certain of the GAAP measures and
certain adjustments made to arrive at the
relevant non-GAAP measure that precludes us from
providing an accurate preliminary estimate of a GAAP
to non-GAAP reconciliation without unreasonable effort or
expense. As a result, we believe that providing estimates of the
amounts that would be required to reconcile the ranges of our
adjusted EBITDA would imply a degree of precision that would be
confusing or misleading to investors for the reasons identified
above.
Adjusted Operating Expenses
Adjusted operating expenses is a non-GAAP financial measure that
represents GAAP operating expenses adjusted to exclude stock-based
compensation expense, and other adjustments to reflect changes that
occur in our business but do not represent ongoing operations.
Set forth below is a reconciliation of operating
expenses, the most directly comparable financial measure calculated
and reported in accordance with GAAP, to adjusted operating
expenses for high and low end of the preliminary ranges set forth
herein for the three months and year ended December 31, 2022. Our
calculation of adjusted operating expenses may not be comparable to
the calculation of similarly titled measures presented by other
companies.
|
Three Months Ended |
|
Year Ended |
|
December 31, 2022 |
|
December 31, 2022 |
(in millions,
unaudited) |
Low |
|
High |
|
Low |
|
High |
GAAP operating expenses |
$ |
38.4 |
|
|
$ |
43.4 |
|
|
$ |
176.5 |
|
|
$ |
181.5 |
|
Stock-based compensation |
|
5.8 |
|
|
|
6.8 |
|
|
|
23.0 |
|
|
|
24.0 |
|
Acquisition-related
expense |
|
0.3 |
|
|
|
1.8 |
|
|
|
31.5 |
|
|
|
33.0 |
|
Adjusted operating
expenses |
$ |
32.3 |
|
|
$ |
34.8 |
|
|
$ |
122.0 |
|
|
$ |
124.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth Quarter and Full Year 2022 Financial Results
Conference Call Information
Fourth quarter and full year 2022 financial
results to be announced after market closes on Thursday, February
23, 2023. Following the release of the financials, the Company will
host a live conference call and webcast at 4:30 p.m. ET.
To access the conference call, please dial (877)
407-8037 (U.S.) or (201) 689-8037 (International) and reference the
“Collegium Pharmaceutical Q4 2022 Earnings Call.” 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 diversified, specialty
pharmaceutical company committed to improving the lives of people
living with serious medical conditions. Collegium’s headquarters
are located in Stoughton, Massachusetts. For more information,
please visit the Company’s website
at www.collegiumpharma.com.
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
related to our fourth quarter and full year 2022 preliminary
financial results, including preliminary product revenue, adjusted
operating expenses and adjusted EBITDA, current and future market
opportunities for our products and our assumptions related thereto,
expectations (financial or otherwise) and intentions, and other
statements that are not historical facts. 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,
including risks relating to, among others: risks related to the
ability to realize the anticipated benefits of our acquisitions at
all or within the expected time period; unknown liabilities; risks
related to future opportunities and plans for our products,
including uncertainty of the expected financial performance of such
products; 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 or other litigation that may be brought by or against
us; the outcome of any governmental investigation related to our
business; 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 Reports on Form 10-K and
Quarterly Reports on Form 10-Q 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.
Investor Contact:Christopher
James, M.D.Vice President, Investor
Relationsir@collegiumpharma.com
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