Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today reported its
financial results for the first quarter 2022 and provided a
corporate update.
“2022 is a pivotal year for Collegium, and we made excellent
progress in the quarter versus our critical priorities,” said Joe
Ciaffoni, President and Chief Executive Officer of Collegium. “The
acquisition of BDSI was strategically and financially
transformational for our organization, and integration has been
seamless to date. For the remainder of the year, we are focused on
growing revenue for Belbuca® and Xtampza® ER, renegotiating Xtampza
ER contracts, exceeding our targeted run rate synergies, and
deploying capital to create shareholder value.”
“Our organization is financially strong and well-positioned to
embark upon a period of growth and value creation,” said Colleen
Tupper, Chief Financial Officer of Collegium. “We are on track to
exceed our targeted run rate synergies of at least $75 million, and
we expect an acceleration in operating cash flow for the remainder
of the year. Our capital allocation priorities are business
development, rapidly paying down debt, and opportunistically
leveraging our share repurchase program to return capital to
shareholders.”
Recent Business Highlights
- Closed the acquisition of BDSI; on track to exceed targeted run
rate synergies of at least $75 million
- Seamlessly transitioned BDSI core operations and achieved
day-one field force readiness
- Grew Belbuca and Xtampza ER total prescriptions 4% and 3%,
respectively, over the first quarter of 2021
- Received approval from the FDA for the Prior Approval
Supplement for a new Nucynta® ER manufacturing site; technology
transfer on track to be completed in 2022
- Executed Master Settlement Agreement resolving all 27 pending
opioid-related lawsuits brought against the Company by cities,
counties, and other subdivisions in the United States
- Appointed Dr. Thomas B. Smith as Chief Medical Officer
- Strengthened Board of Directors with the appointment of Neil F.
McFarlane, former Chief Executive Officer and director of Adamas
Pharmaceuticals
Financial Results for the First Quarter Ended March 31,
2022
- Total net product revenues were $83.8 million for the quarter
ended March 31, 2022 (the “2022 Quarter”), compared to $87.7
million for the quarter ended March 31, 2021 (the “2021
Quarter”)
- GAAP operating expenses were $58.5 million for the 2022
Quarter, compared to $34.4 million for the 2021 Quarter; adjusted
operating expenses, which excludes stock-based compensation of $6.1
million and acquisition related expenses of $27.2 million, were
$25.2 million for the 2022 Quarter, compared to $27.5 million for
the 2021 Quarter, which excludes stock-based compensation of $6.9
million
- Net loss for the 2022 Quarter, which includes acquisition
related expenses, was $13.1 million, or $0.39 loss per share (basic
and diluted), compared to net income of $15.7 million, or $0.45
earnings per share (basic) and $0.41 earnings per share (diluted),
for the 2021 Quarter; Income from operations, excluding acquisition
related expenses, for the 2022 Quarter was $17.2 million
- Adjusted EBITDA for the 2022 Quarter was $43.5 million,
compared to $45.3 million for the 2021 Quarter
- The Company exited the 2022 Quarter with a cash balance of
$106.7 million
Financial Guidance for 2022
The Company reaffirms financial guidance for the
full year 2022, originally provided on April 5, 2022:
- Total product revenues are expected in the range of $450.0
million to $465.0 million, up approximately 65% at the midpoint
compared to net product revenue of $276.9 million in 2021;
- Total adjusted operating expenses, which excludes stock-based
compensation expense and acquisition related expenses, are expected
in the range of $130.0 million to $140.0 million; and
- Total adjusted EBITDA which excludes stock-based compensation
and acquisition related expenses, is expected in the range of
$235.0 million to $250.0 million.
Conference Call Information
The Company will host a conference call and live audio webcast
on Tuesday, May 10, 2022, at 4:30 p.m. Eastern Time. To access the
conference call, please dial (877) 407-8037 (U.S.) or (201)
689-8037 (International) and reference the “Collegium Q1 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.
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 adjusted operating expenses.
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, 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 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 as the amount and/or frequency of these expenses are
not part of our underlying business.
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.
The Company has not provided a reconciliation of its full-year
2022 guidance for adjusted EBITDA or adjusted operating expenses to
the most directly comparable forward-looking GAAP measures 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 and operating expenses for the guidance period.
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 2022 financial guidance, including total 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. Actual results may differ
materially from management’s expectations and such forward-looking
statements in this press release could be affected as a result of
various important factors, including risks relating to, among
others: risks related to the ability to realize the anticipated
benefits of our acquisition of BDSI, including the possibility that
the expected benefits from the BDSI acquisition will not be
realized or will not be realized within the expected time period;
the risk that BDSI’s business will not be integrated successfully;
negative effects of the consummation of the BDSI acquisition on the
market price of our common stock and/or operating results; unknown
liabilities; risks related to future opportunities and plans for
the products acquired with BDSI, 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, opioid-related or other litigation that may be
brought by or against us, including litigation with Purdue Pharma,
L.P.; 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.
Contact: Alex Dasalla Head of Investor Relations
adasalla@collegiumpharma.com
|
Collegium Pharmaceutical, Inc.Unaudited
Selected Consolidated Balance Sheet Information(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2022 |
|
2021 |
Cash and cash equivalents |
|
$ |
106,698 |
|
|
$ |
186,426 |
|
Accounts receivable, net |
|
|
166,345 |
|
|
|
105,844 |
|
Inventory |
|
|
80,146 |
|
|
|
17,394 |
|
Prepaid expenses and other
current assets |
|
|
10,449 |
|
|
|
5,879 |
|
Property and equipment,
net |
|
|
20,202 |
|
|
|
19,491 |
|
Operating lease assets |
|
|
7,812 |
|
|
|
7,644 |
|
Intangible assets, net |
|
|
694,799 |
|
|
|
268,723 |
|
Restricted cash |
|
|
2,547 |
|
|
|
2,547 |
|
Deferred tax assets |
|
|
25,554 |
|
|
|
78,042 |
|
Other noncurrent assets |
|
|
77 |
|
|
|
87 |
|
Goodwill |
|
|
131,512 |
|
|
|
— |
|
Total assets |
|
$ |
1,246,141 |
|
|
$ |
692,077 |
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued
expenses |
|
|
44,919 |
|
|
|
33,403 |
|
Accrued rebates, returns and
discounts |
|
|
227,476 |
|
|
|
196,996 |
|
Term notes payable |
|
|
628,390 |
|
|
|
110,019 |
|
Convertible senior notes |
|
|
140,189 |
|
|
|
139,966 |
|
Operating lease
liabilities |
|
|
9,091 |
|
|
|
8,765 |
|
Shareholders’ equity |
|
|
196,076 |
|
|
|
202,928 |
|
Total liabilities and
stockholders’ equity |
|
$ |
1,246,141 |
|
|
$ |
692,077 |
|
|
|
|
|
|
|
|
|
|
|
Collegium Pharmaceutical, Inc.Unaudited
Condensed Statements of Operations(in thousands, except
share and per share amounts) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
2022 |
|
2021 |
Product revenues, net |
$ |
83,751 |
|
|
$ |
87,721 |
|
Cost of product revenues |
|
|
|
|
|
Cost of product revenues (excluding intangible asset
amortization) |
|
16,332 |
|
|
|
15,328 |
|
Intangible asset amortization |
|
18,923 |
|
|
|
16,795 |
|
Total cost of products
revenues |
|
35,255 |
|
|
|
32,123 |
|
Gross profit |
|
48,496 |
|
|
|
55,598 |
|
Operating expenses |
|
|
|
|
|
Research and development |
|
3,983 |
|
|
|
2,930 |
|
Selling, general and administrative |
|
54,528 |
|
|
|
31,476 |
|
Total operating expenses |
|
58,511 |
|
|
|
34,406 |
|
(Loss) income from
operations |
|
(10,015 |
) |
|
|
21,192 |
|
Interest expense |
|
(5,831 |
) |
|
|
(5,721 |
) |
Interest income |
|
4 |
|
|
|
3 |
|
(Loss) income before income
taxes |
|
(15,842 |
) |
|
|
15,474 |
|
(Benefit from) Provision for income taxes |
|
(2,773 |
) |
|
|
(188 |
) |
Net (loss) income |
$ |
(13,069 |
) |
|
$ |
15,662 |
|
|
|
|
|
|
|
(Loss) earnings per share —
basic |
$ |
(0.39 |
) |
|
$ |
0.45 |
|
Weighted-average shares —
basic |
|
33,673,912 |
|
|
|
34,951,740 |
|
|
|
|
|
|
|
(Loss) earnings per share —
diluted |
$ |
(0.39 |
) |
|
$ |
0.41 |
|
Weighted-average shares —
diluted |
|
33,673,912 |
|
|
|
41,160,092 |
|
|
|
|
|
|
|
|
|
|
Collegium Pharmaceutical,
Inc.Reconciliation of GAAP Net Income to Adjusted
EBITDA(in thousands)(unaudited) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
2022 |
|
2021 |
GAAP Net (loss) income |
$ |
(13,069 |
) |
|
$ |
15,662 |
|
Adjustments: |
|
|
|
|
|
Interest expense |
|
5,831 |
|
|
|
5,721 |
|
Interest income |
|
(4 |
) |
|
|
(3 |
) |
(Benefit from) Provision for income taxes |
|
(2,773 |
) |
|
|
(188 |
) |
Depreciation |
|
715 |
|
|
|
439 |
|
Amortization |
|
18,923 |
|
|
|
16,795 |
|
Stock-based compensation expense |
|
6,135 |
|
|
|
6,879 |
|
Acquisition related expense |
|
27,167 |
|
|
|
— |
|
Recognition of step-up basis in inventory |
|
603 |
|
|
|
— |
|
Total adjustments |
$ |
56,597 |
|
|
$ |
29,643 |
|
Adjusted EBITDA |
$ |
43,528 |
|
|
$ |
45,305 |
|
|
|
|
|
|
|
|
|
|
Collegium Pharmaceutical,
Inc.Reconciliation of GAAP Operating Expenses to
Adjusted Operating Expenses(in thousands)(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
2022 |
|
2021 |
GAAP Operating expenses |
$ |
58,511 |
|
|
$ |
34,406 |
|
Adjustments: |
|
|
|
|
|
|
|
Stock-based compensation |
|
6,135 |
|
|
|
6,879 |
|
Acquisition related expense |
|
27,167 |
|
|
|
— |
|
Total adjustments |
|
33,302 |
|
|
|
6,879 |
|
Adjusted operating
expenses |
$ |
25,209 |
|
|
$ |
27,527 |
|
|
|
|
|
|
|
|
|
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