Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading,
diversified specialty pharmaceutical company, today announced its
2023 full-year financial guidance and provided a business update.
“2022 was a pivotal year for Collegium. We
achieved the first two phases of our Three Phase Action Agenda,
which included integrating BDSI, completing Xtampza® ER contract
renegotiations to ensure gross-to-net of less than 65%, and
generating momentum across our differentiated and distinctly
positioned pain portfolio,” said Joe Ciaffoni, President and Chief
Executive Officer of Collegium. “With these accomplishments, 2023
is set to be a banner year. We are focused on executing Phase 3,
Accelerate, building our leadership position in responsible pain
management, and deploying capital to maximize shareholder
value.”
“Driven by Xtampza ER and Belbuca®, we expect to
immediately accelerate revenue growth making 2023 a banner year for
Collegium. With our fully synergized cost structure, we expect
significant bottom-line expansion, with adjusted EBITDA expected to
grow at over four times the rate of adjusted operating expenses,”
said Colleen Tupper, Chief Financial Officer of Collegium. “We are
committed to deploying capital in a disciplined manner with
business development as our highest priority. We plan to continue
rapidly paying down debt and opportunistically returning capital to
shareholders through our new $100 million share repurchase
program.”
Recent Business Highlights
- Collegium’s board of directors authorized a new share
repurchase program for 2023 to repurchase up to $100 million in
common stock
- Returned $19.1 million in capital to shareholders in 2022 under
the share repurchase program authorized by Collegium’s board of
directors in August 2021, including $4.0 million repurchased since
November 3, 2022
- In December 2022, the Federal Circuit upheld the judgment of
the U.S. District Court for the District of Delaware that certain
claims of the patents protecting Belbuca are valid. Collegium
expects that, by virtue of the Federal Circuit’s decision, Alvogen
will be barred from entering the market with its product until
2032
- Completed Xtampza ER contract renegotiations in 2022,
maintaining broad access while significantly decreasing rebates;
Xtampza ER gross-to-net is expected to be in the range of 61% to
63% in 2023
Financial Guidance for 2023
- Product revenues, net are expected
in the range of $565.0 million to $580.0 million
- Adjusted operating expenses
(excluding stock-based compensation) are expected in the range of
$135.0 million to $145.0 million
- Adjusted EBITDA (excluding
stock-based compensation) is expected in the range of $355.0
million to $370.0 million
* Non-GAAP financial measure. Please refer to the “Non-GAAP
Financial Measures” section for details regarding these
measures.
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.
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 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, 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 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 consist of financial
advisory, banking, legal, and regulatory fees, and other consulting
fees, incurred to complete an 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.
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.
We have not provided a reconciliation of our
full-year 2023 guidance for adjusted EBITDA or adjusted operating
expenses to the most directly comparable forward-looking GAAP
measures, in reliance on the unreasonable efforts exception
provided
under Item 10(e)(1)(i)(B) of Regulation S-K,
because we are 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, acquisition related expense and litigation
settlements. These items are uncertain and depend on various
factors that are outside of the Company’s control or cannot be
reasonably predicted. While we are unable to address the probable
significance of these items, they could have a material impact on
GAAP net income and operating expenses for the guidance period. A
reconciliation adjusted EBITDA or adjusted operating expenses would
imply a degree of precision and certainty as to these future items
that does not exist and could be confusing to investors.
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 full-year 2023 financial guidance, including
projected 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:Dawn
Schottlandt Argot Partnerscollegium@argotpartners.com
Media Contact:Marissa
SamuelsCorporate
Communicationscommunications@collegiumpharma.com
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