Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading,
diversified specialty pharmaceutical company, today announced its
2024 full-year financial guidance and provided a business update.
“2023 was a banner year for Collegium. We are on
track to grow revenue over 20% and adjusted EBITDA over 35% in 2023
compared to 2022, leading to strong cash flow generation that
enabled us to rapidly pay down debt and opportunistically
repurchase shares. Our operational accomplishments position the
Company to deliver top- and bottom-line growth in 2024 and
strengthen our outlook for 2025 and 2026,” said Joe Ciaffoni,
President and Chief Executive Officer of Collegium. “In 2024, we
are focused on operational execution, which includes achieving our
financial commitments and deploying capital to create value for
shareholders.”
“We expect record revenue, driven by Belbuca®
and Xtampza® ER growth, and disciplined operating spend, to result
in record adjusted EBITDA in 2024,” said Colleen Tupper, Chief
Financial Officer of Collegium. “We plan to deploy capital to
rapidly pay down debt and opportunistically utilize our new $150
million share repurchase program to return value to our
shareholders.”
Recent Business Highlights
- Collegium’s board of directors
authorized a new share repurchase program to repurchase up to
$150.0 million in common stock over 18 months.
- Returned $75.0 million in capital
to shareholders in 2023 under the share repurchase program
authorized by Collegium’s board of directors in January 2023,
including $25.0 million repurchased through an accelerated share
repurchase program since November 9, 2023.
- Successfully completed Xtampza ER
contract renegotiations with payors that represent 30% of Xtampza
ER total prescriptions in 2023. As a result, Xtampza ER
gross-to-net is expected to be in the range of 56% to 58% in
2024.
- Renegotiated a major Medicare Part
D contract for Belbuca, maintaining its access position and
materially reducing the rebate, and won a new Medicare Part D plan
for Belbuca representing approximately one million covered
lives.
Financial Guidance for 2024
- Product revenues, net are expected
in the range of $580.0 million to $595.0 million.
- Adjusted operating expenses
(excluding stock-based compensation) are expected in the range of
$120.0 million to $125.0 million.
- Adjusted EBITDA (excluding
stock-based compensation) is expected in the range of $380.0
million to $395.0 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 (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 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 related
expenses incurred;
- 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; and
- we exclude losses on
extinguishments of debt as these expenses are episodic in nature
and do not directly correlate to the cost of operating our business
on an ongoing basis.
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 2024 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 of 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 2024 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: unknown liabilities; risks related to future opportunities
and plans for our products, including uncertainty of the expected
financial performance of such 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
Media Contact:Marissa
SamuelsVice President, Corporate
Communicationscommunications@collegiumpharma.com
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