Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading,
diversified specialty pharmaceutical company, today reported its
financial results for the quarter ended June 30, 2022 and provided
a corporate update.
“Following closing of the financially transformative acquisition
of BDSI, the Collegium team successfully completed phase one,
Seamless Integration, of our three-phase action agenda, effectively
transitioning operations and achieving day-one commercial
readiness. We remain on track to exceed targeted run rate synergies
of at least $75 million,” said Joe Ciaffoni, President and Chief
Executive Officer of Collegium. “In July, we transitioned to phase
two, Generate Momentum, and are focused on growing Belbuca® and
Xtampza® ER prescriptions, and successfully renegotiating Xtampza
ER contracts that will ensure gross-to-net of less than 65%
beginning in January 2023. Phase three, Accelerate, begins in
January 2023, and will be propelled by Xtampza ER revenue growth
and Belbuca and Xtampza ER prescription growth, and bolstered by a
fully synergized cost structure.”
“In the second quarter, our first full quarter post the BDSI
acquisition, we delivered record revenue, leveraged our cost
structure, generated significant operating cashflows, and paid down
debt,” said Colleen Tupper, Chief Financial Officer of Collegium.
“Our financial position is strong, and we remain focused on
strategically deploying our capital to create value for our
shareholders.”
First Half 2022 Business Highlights
- Completed phase one, Seamless
Integration, of the three-phase action agenda following the close
of the BDSI acquisition
- Increased Collegium’s market share
of the Branded ER market to 49.0% in June 2022
- Grew Belbuca market share to 17.7%
of the Branded ER market and Xtampza ER market share to 35.0% of
the oxycodone ER market in June 2022
- Transitioned BDSI core operations
and achieved day-one commercial readiness following the close of
the BDSI acquisition
- Executed a master settlement
agreement resolving all 27-pending opioid industry-related lawsuits
brought against the Company by cities, counties, and other
subdivisions in the United States
- Presented four poster presentations
and one oral presentation on Elyxyb™ at the American Headache
Society 64th Annual Scientific Meeting
Financial Guidance for 2022
- The Company updates its full-year 2022 guidance for Total
Adjusted Operating Expenses and Total Adjusted EBITDA:
|
Prior |
Updated |
|
|
|
Total Product Revenues |
$450.0 to $465.0 million |
Reaffirmed |
|
|
|
Total Adjusted Operating Expenses(Excluding Stock-Based
Compensation and Acquisition Related Expenses) |
$130.0 to $140.0 million |
$125.0 to $135.0 million |
|
|
|
Total Adjusted EBITDA(Excluding Stock-Based Compensation and
Acquisition Related Expenses) |
$235.0 to $250.0 million |
$245.0 to $255.0 million |
|
|
|
Financial Results for Quarter Ended June 30,
2022
- Total net product revenues were
$123.5 million for the quarter ended June 30, 2022 (the “2022
Quarter”), compared to $82.9 million for the quarter ended June 30,
2021 (the “2021 Quarter”)
- GAAP operating expenses were $41.3
million for the 2022 Quarter, compared to $33.8 million for the
2021 Quarter; Adjusted operating expenses, which exclude
stock-based compensation expense of $5.7 million and acquisition
expense of $3.6 million, were $32.0 million for the 2022 Quarter,
compared to $27.3 million for the 2021 Quarter, which excluded
stock-based compensation of $6.5 million
- Net loss for the 2022 Quarter was
$5.2 million, or $0.15 loss per share (basic and diluted), compared
to net income of $72.8 million, or $2.06 earnings per share (basic)
and $1.79 earnings per share (diluted), which included the discrete
tax benefit related to the release of the valuation allowance, for
the 2021 Quarter; income from operations, excluding acquisition
related expenses, was $14.7 million for the 2022 Quarter compared
to $16.4 million for the 2021 Quarter
- Adjusted EBITDA for the 2022 Quarter
was $71.2 million, compared to $40.1 million for the 2021
Quarter
- The Company exited the 2022 Quarter
with a cash balance of $122.7 million
Conference Call Information
The Company will host a conference call and live audio webcast
on Thursday, August 4, 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 Q2 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.
In our quarterly and annual reports, earnings press releases and
conference calls, we may discuss the following financial measures
that are not calculated in accordance with GAAP, to supplement our
consolidated financial statements presented on a GAAP basis.
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 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
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;
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) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2022 |
|
2021 |
Cash and cash equivalents |
|
$ |
122,722 |
|
$ |
186,426 |
Accounts receivable, net |
|
|
197,505 |
|
|
105,844 |
Inventory |
|
|
77,769 |
|
|
17,394 |
Prepaid expenses and other
current assets |
|
|
11,778 |
|
|
5,879 |
Property and equipment,
net |
|
|
19,965 |
|
|
19,491 |
Operating lease assets |
|
|
7,257 |
|
|
7,644 |
Intangible assets, net |
|
|
647,299 |
|
|
268,723 |
Restricted cash |
|
|
2,547 |
|
|
2,547 |
Deferred tax assets |
|
|
28,571 |
|
|
78,042 |
Other noncurrent assets |
|
|
67 |
|
|
87 |
Goodwill |
|
|
130,094 |
|
|
— |
Total assets |
|
$ |
1,245,574 |
|
$ |
692,077 |
|
|
|
|
|
|
|
Accounts payable and accrued
expenses |
|
|
46,331 |
|
|
33,403 |
Accrued rebates, returns and
discounts |
|
|
246,719 |
|
|
196,996 |
Term notes payable |
|
|
605,686 |
|
|
110,019 |
Convertible senior notes |
|
|
140,415 |
|
|
139,966 |
Operating lease
liabilities |
|
|
8,811 |
|
|
8,765 |
Shareholders’ equity |
|
|
197,612 |
|
|
202,928 |
Total liabilities and
stockholders’ equity |
|
$ |
1,245,574 |
|
$ |
692,077 |
|
Collegium Pharmaceutical, Inc.Unaudited
Condensed Statements of Operations(in thousands, except
share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Product revenues, net |
$ |
123,549 |
|
|
$ |
82,942 |
|
|
$ |
207,300 |
|
|
$ |
170,663 |
|
Cost of product revenues |
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues (excluding intangible asset
amortization) |
|
33,684 |
|
|
|
15,908 |
|
|
|
50,016 |
|
|
|
31,236 |
|
Intangible asset amortization |
|
37,501 |
|
|
|
16,795 |
|
|
|
56,424 |
|
|
|
33,590 |
|
Total cost of products
revenues |
|
71,185 |
|
|
|
32,703 |
|
|
|
106,440 |
|
|
|
64,826 |
|
Gross profit |
|
52,364 |
|
|
|
50,239 |
|
|
|
100,860 |
|
|
|
105,837 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
— |
|
|
|
3,462 |
|
|
|
3,983 |
|
|
|
6,392 |
|
Selling, general and administrative |
|
41,254 |
|
|
|
30,368 |
|
|
|
95,782 |
|
|
|
61,844 |
|
Total operating expenses |
|
41,254 |
|
|
|
33,830 |
|
|
|
99,765 |
|
|
|
68,236 |
|
Income from operations |
|
11,110 |
|
|
|
16,409 |
|
|
|
1,095 |
|
|
|
37,601 |
|
Interest expense |
|
(17,761 |
) |
|
|
(5,421 |
) |
|
|
(23,592 |
) |
|
|
(11,142 |
) |
Interest income |
|
5 |
|
|
|
3 |
|
|
|
9 |
|
|
|
6 |
|
(Loss) income before income
taxes |
|
(6,646 |
) |
|
|
10,991 |
|
|
|
(22,488 |
) |
|
|
26,465 |
|
Benefit from income taxes |
|
(1,455 |
) |
|
|
(61,852 |
) |
|
|
(4,228 |
) |
|
|
(62,040 |
) |
Net (loss) income |
$ |
(5,191 |
) |
|
$ |
72,843 |
|
|
$ |
(18,260 |
) |
|
$ |
88,505 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings per share —
basic |
$ |
(0.15 |
) |
|
$ |
2.06 |
|
|
$ |
(0.54 |
) |
|
$ |
2.52 |
|
Weighted-average shares —
basic |
|
34,001,553 |
|
|
|
35,302,608 |
|
|
|
33,838,638 |
|
|
|
35,128,144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings per share —
diluted |
$ |
(0.15 |
) |
|
$ |
1.79 |
|
|
$ |
(0.54 |
) |
|
$ |
2.20 |
|
Weighted-average shares —
diluted |
|
34,001,553 |
|
|
|
41,286,853 |
|
|
|
33,838,638 |
|
|
|
41,251,749 |
|
|
Collegium Pharmaceutical,
Inc.Reconciliation of GAAP Net Income to Adjusted
EBITDA(in thousands)(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
GAAP Net (loss) income |
$ |
(5,191 |
) |
|
$ |
72,843 |
|
|
$ |
(18,260 |
) |
|
$ |
88,505 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
17,761 |
|
|
|
5,421 |
|
|
|
23,592 |
|
|
|
11,142 |
|
Interest income |
|
(5 |
) |
|
|
(3 |
) |
|
|
(9 |
) |
|
|
(6 |
) |
Benefit from income taxes |
|
(1,455 |
) |
|
|
(61,852 |
) |
|
|
(4,228 |
) |
|
|
(62,040 |
) |
Depreciation |
|
656 |
|
|
|
425 |
|
|
|
1,371 |
|
|
|
864 |
|
Amortization |
|
37,501 |
|
|
|
16,795 |
|
|
|
56,424 |
|
|
|
33,590 |
|
Stock-based compensation expense |
|
5,692 |
|
|
|
6,516 |
|
|
|
11,827 |
|
|
|
13,395 |
|
Acquisition related expense |
|
3,579 |
|
|
|
— |
|
|
|
30,746 |
|
|
|
— |
|
Recognition of step-up basis in inventory |
|
12,638 |
|
|
|
— |
|
|
|
13,241 |
|
|
|
— |
|
Total adjustments |
$ |
76,367 |
|
|
$ |
(32,698 |
) |
|
$ |
132,964 |
|
|
$ |
(3,055 |
) |
Adjusted EBITDA |
$ |
71,176 |
|
|
$ |
40,145 |
|
|
$ |
114,704 |
|
|
$ |
85,450 |
|
|
Collegium Pharmaceutical,
Inc.Reconciliation of GAAP Operating Expenses to
Adjusted Operating Expenses(in thousands)(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
GAAP Operating expenses |
$ |
41,254 |
|
|
$ |
33,830 |
|
|
$ |
99,765 |
|
|
$ |
68,236 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
5,692 |
|
|
|
6,516 |
|
|
|
11,827 |
|
|
|
13,395 |
|
Acquisition related expense |
|
3,579 |
|
|
|
— |
|
|
|
30,746 |
|
|
|
— |
|
Total adjustments |
|
9,271 |
|
|
|
6,516 |
|
|
|
42,573 |
|
|
|
13,395 |
|
Adjusted operating
expenses |
$ |
31,983 |
|
|
$ |
27,314 |
|
|
$ |
57,192 |
|
|
$ |
54,841 |
|
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