Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty
pharmaceutical company committed to being the leader in responsible
pain management, today reported its financial results for the
fourth quarter and year ended December 31, 2020 and provided a
corporate update.
“Our differentiated pain portfolio performed well during the
fourth quarter, laying the groundwork for a strong start in the new
year,” said Joe Ciaffoni, President and Chief Executive Officer of
Collegium. “As we turn to 2021, we are encouraged by underlying
trends in our business and remain focused on maximizing the
potential of our portfolio and creating value for our shareholders.
As always, we are committed to being the leader in responsible pain
management and will continue to prioritize the health and safety of
our people, customers and the communities that we serve.”
“The fourth quarter capped a financially transformative 2020 for
Collegium, in which Xtampza ER growth and the acquisition of the
Nucynta franchise enabled us to deliver profitability and generate
significant cash flows,” said Paul Brannelly, Executive Vice
President and Chief Financial Officer of Collegium. “Our 2021
outlook is supported by early Xtampza ER growth trends, expected
stable profit contributions from the Nucynta franchise and our
ability to continue to leverage our cost structure. This year we
are focused on profitability, strong cash generation and remaining
focused and disciplined in our approach to capital allocation.”
Recent Business Highlights
- Xtampza ER market share of the oxycodone extended-release
market grew to 25.1% in December 2020, from 18.9% in December
2019.
- Effective January 1, 2021, the Company secured new exclusive ER
oxycodone formulary wins for Xtampza ER within a major national
Medicare Part D plan and several regional commercial plans, as well
as parity formulary positions for select regional commercial plans.
With these new exclusive and parity formulary positions, Xtampza ER
will be the exclusive branded ER oxycodone for approximately 92
million lives and will be in a parity position for approximately 30
million lives.
- A publication titled, “Postmarketing Analysis of Misuse, Abuse
and Diversion of Xtampza ER,” was published in the peer-reviewed
medical journal, Pain Medicine in October. The publication
contains a postmarketing analysis of real-world evidence related to
Xtampza ER which provides data that can enrich the scientific and
clinical evaluation of abuse deterrent formulations.
- Collegium was recognized as a 2021 Top Workplaces USA Company
and was ranked #1 on Boston Business Journal’s 2021 Middle Market
Leaders list.
Financial Results for Quarter Ended December 31,
2020
- Xtampza ER net product revenues were $30.8 million for the
quarter ended December 31, 2020 (the “2020 Quarter”), compared to
$27.4 million for the quarter ended December 31, 2019 (the “2019
Quarter”), representing an increase of 12%.
- Nucynta franchise net product revenues were $45.5 million in
the 2020 Quarter, compared to $46.8 million for the 2019 Quarter,
representing a decrease of 3%.
- Operating expenses, which includes stock-based compensation,
were $29.3 million for the 2020 Quarter, compared to $27.5 million
for the 2019 Quarter.
- Net income for the 2020 Quarter was $7.0 million, or $0.20
earnings per share (basic and diluted), compared to net loss of
$2.2 million, or $0.07 loss per share (basic and diluted), for the
2019 Quarter. Net income and net loss included stock-based
compensation expense of $6.2 million and $4.0 million for the 2020
Quarter and 2019 Quarter, respectively.
- Non-GAAP adjusted income for the 2020 Quarter was $32.8
million, compared to non-GAAP adjusted income of $5.5 million for
the 2019 Quarter.
- Adjusted EBITDA for the 2020 Quarter was $38.3 million,
compared to $5.5 million for the 2019 Quarter.
Full-Year 2020 Financial Highlights
- For the year ended December 31, 2020, total net product
revenues were $310.0 million, which included Xtampza ER net
revenues of $128.0 million and Nucynta franchise net revenues of
$182.0 million. This compared to total net product revenues of
$296.7 million for the year ended December 31, 2019, which included
Xtampza ER net revenues of $105.0 million and Nucynta franchise net
revenues of $191.7 million.
- Operating expenses, including stock-based compensation, for the
year ended December 31, 2020 were $123.6 million, compared to
$126.8 million for the year ended December 31, 2019. The decrease
was primarily related to a decrease in sales and marketing expenses
driven by the effects of the COVID-19 pandemic.
- Net income for the year ended December 31, 2020 was $26.8
million, or $0.78 earnings per share (basic) and $0.76 earnings per
share (diluted), compared to a net loss of $22.7 million, or $0.68
loss per share (basic and diluted) for the year ended December 31,
2019.
- Non-GAAP adjusted income for the year ended December 31, 2020
was $133.4 million compared to $8.6 million for the year ended
December 31, 2019.
- Adjusted EBITDA for the year ended December 31, 2020 was $139.7
million, compared to $8.3 million for the year ended December 31,
2019.
- The Company had cash and cash equivalents of $174.1 million at
December 31, 2020.
Financial Guidance for 2021
The Company reiterates its full-year 2021 financial guidance,
initially provided on January 6, 2021:
- Xtampza ER revenues are expected in the range of $155.0
million to $165.0 million
- Nucynta franchise revenues are expected in the range of $175.0
million to $185.0 million
- Total operating expenses are expected in the range of $125.0
million to $135.0 million
- Adjusted EBITDA (excluding stock-based compensation) is
expected in the range of $160.0 million to $170.0 million
Collegium is not providing forward-looking guidance for its
full-year 2021 U.S. GAAP net income (loss) or a quantitative
reconciliation of forward-looking adjusted EBITDA. Please see
“Non-GAAP Financial Measures” below for additional information.
Conference Call Information
The Company will host a conference call and live audio webcast
on Thursday, February 25, 2021 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
Pharmaceutical Q4 2020 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 specialty pharmaceutical company committed to
being the leader in responsible pain management. 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 non-GAAP adjusted income (loss)
and non-GAAP adjusted EBITDA. We use these non-GAAP financial
measures to understand, manage and evaluate the Company as we
believe they represent the performance of our core business.
Because non-GAAP adjusted income (loss) and non-GAAP adjusted
EBITDA are important internal measures for the Company, we believe
that the presentation of these non-GAAP financial measures provide
analysts, investors, lenders and other third parties insight into
management’s view and assessment of the Company’s ongoing operating
performance. In addition, we believe that the presentation of these
non-GAAP financial measures, when viewed with our results under
GAAP, provides supplementary information that may be useful to
analysts, investors, lenders, and other third parties in assessing
the Company’s performance and results from period to period. We
report non-GAAP financial measures, including adjusted income
(loss) and adjusted EBITDA, to portray the results of our major
operations prior to considering certain income statement elements.
These non-GAAP 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.
Non-GAAP adjusted income (loss) is not based on any standardized
methodology prescribed by GAAP and represents GAAP net income
(loss) adjusted to exclude stock-based compensation expense,
amortization expense, non-cash interest expense, and minimum
royalty payments due and payable in connection with the Nucynta
Commercialization Agreement. Any non-GAAP financial measures used
by us may be calculated differently from, and therefore may not be
comparable to, a non-GAAP measure used by other companies. Please
see the section of this press release titled “Reconciliation of
GAAP to Non-GAAP Financial Information” for a reconciliation of
non-GAAP adjusted loss to its most directly comparable GAAP
measure.
Adjusted EBITDA represents GAAP net income (loss) adjusted to
exclude interest expense, income tax expense, depreciation,
amortization, and stock-based compensation. 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 provision for income taxes or
the cash requirements to pay taxes; and
- adjusted EBITDA does not reflect historical cash expenditures
or future requirements for capital expenditures or contractual
commitments.
The Company has not provided a reconciliation of its full-year
2021 guidance for non-GAAP adjusted EBITDA to the most directly
comparable forward-looking GAAP measure 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 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 regarding
financial guidance for Xtampza ER and Nucynta Franchise revenues,
Adjusted EBITDA, total operating expenses, current and future
market opportunities for our products and our assumptions related
thereto. 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. Management's expectations and,
therefore, any forward-looking statements in this press release
could also be affected by risks and uncertainties relating to a
number of other factors, including 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 Report on Form 10-K
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 Dasallaadasalla@collegiumpharma.com
Collegium Pharmaceutical,
Inc.
Unaudited Selected Consolidated Balance
Sheet Information(in thousands)
|
|
December 31, |
|
|
2020 |
|
2019 |
Cash and cash equivalents |
|
$ |
174,116 |
|
|
|
170,019 |
|
Accounts receivable |
|
|
83,320 |
|
|
|
72,953 |
|
Inventory |
|
|
15,614 |
|
|
|
9,643 |
|
Prepaid expenses and other
current assets |
|
|
4,838 |
|
|
|
3,105 |
|
Property and equipment,
net |
|
|
18,988 |
|
|
|
11,854 |
|
Operating lease assets |
|
|
8,391 |
|
|
|
9,047 |
|
Intangible assets, net |
|
|
335,904 |
|
|
|
29,503 |
|
Restricted cash |
|
|
2,547 |
|
|
|
— |
|
Other long-term assets |
|
|
123 |
|
|
|
178 |
|
Total assets |
|
$ |
643,841 |
|
|
$ |
306,302 |
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued
expenses |
|
|
34,672 |
|
|
|
39,727 |
|
Accrued rebates, returns and
discounts |
|
|
156,554 |
|
|
|
157,549 |
|
Term notes payable |
|
|
157,514 |
|
|
|
11,500 |
|
Convertible senior notes |
|
|
99,575 |
|
|
|
— |
|
Operating lease
liabilities |
|
|
9,495 |
|
|
|
10,094 |
|
Shareholders’ equity |
|
|
186,031 |
|
|
|
87,432 |
|
Total liabilities and
stockholders’ equity |
|
$ |
643,841 |
|
|
$ |
306,302 |
|
Collegium Pharmaceutical,
Inc.
Unaudited Condensed Statements of
Operations(in thousands, except share and per share
amounts)
|
|
Three months ended December 31, |
|
Year ended December 31, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Product revenues, net |
|
$ |
76,271 |
|
|
$ |
74,203 |
|
|
$ |
310,016 |
|
|
$ |
296,701 |
|
Cost of product revenues |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues (excluding intangible asset
amortization) |
|
|
15,184 |
|
|
|
45,400 |
|
|
|
69,500 |
|
|
|
178,908 |
|
Intangible asset amortization |
|
|
16,795 |
|
|
|
3,688 |
|
|
|
60,680 |
|
|
|
14,752 |
|
Total cost of products
revenues |
|
|
31,979 |
|
|
|
49,088 |
|
|
|
130,180 |
|
|
|
193,660 |
|
Gross profit |
|
|
44,292 |
|
|
|
25,115 |
|
|
|
179,836 |
|
|
|
103,041 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,472 |
|
|
|
2,398 |
|
|
|
9,772 |
|
|
|
10,340 |
|
Selling, general and administrative |
|
|
26,824 |
|
|
|
25,090 |
|
|
|
113,832 |
|
|
|
116,449 |
|
Total operating expenses |
|
|
29,296 |
|
|
|
27,488 |
|
|
|
123,604 |
|
|
|
126,789 |
|
Income (loss) from
operations |
|
|
14,996 |
|
|
|
(2,373 |
) |
|
|
56,232 |
|
|
|
(23,748 |
) |
Interest expense |
|
|
(7,737 |
) |
|
|
(211 |
) |
|
|
(28,882 |
) |
|
|
(909 |
) |
Interest income |
|
|
3 |
|
|
|
383 |
|
|
|
232 |
|
|
|
1,935 |
|
Income (loss) before income
taxes |
|
|
7,262 |
|
|
|
(2,201 |
) |
|
|
27,582 |
|
|
|
(22,722 |
) |
Provision for income taxes |
|
|
304 |
|
|
|
— |
|
|
|
830 |
|
|
|
— |
|
Net income (loss) |
|
$ |
6,958 |
|
|
$ |
(2,201 |
) |
|
$ |
26,752 |
|
|
$ |
(22,722 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per share —
basic |
|
$ |
0.20 |
|
|
$ |
(0.07 |
) |
|
$ |
0.78 |
|
|
$ |
(0.68 |
) |
Weighted-average shares —
basic |
|
|
34,592,277 |
|
|
|
33,600,566 |
|
|
|
34,407,959 |
|
|
|
33,453,844 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per share —
diluted |
|
$ |
0.20 |
|
|
$ |
(0.07 |
) |
|
$ |
0.76 |
|
|
$ |
(0.68 |
) |
Weighted-average shares —
diluted |
|
|
35,417,623 |
|
|
|
33,600,566 |
|
|
|
35,151,353 |
|
|
|
33,453,844 |
|
Collegium Pharmaceutical,
Inc.
Reconciliation of GAAP to Non-GAAP
Financial Information(in thousands, except per share
amounts)(unaudited)
|
|
Three months ended |
|
Year ended |
|
|
December 31, |
|
December 31, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
GAAP net income (loss) |
|
$ |
6,958 |
|
|
$ |
(2,201 |
) |
|
$ |
26,752 |
|
|
$ |
(22,722 |
) |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense(1) |
|
|
6,210 |
|
|
|
3,966 |
|
|
|
21,910 |
|
|
|
16,528 |
|
Intangible asset amortization(2) |
|
|
16,795 |
|
|
|
3,688 |
|
|
|
60,680 |
|
|
|
14,752 |
|
Non-cash interest expense(3) |
|
|
2,545 |
|
|
|
— |
|
|
|
8,972 |
|
|
|
— |
|
Nucynta royalty adjustment (4) |
|
|
— |
|
|
|
— |
|
|
|
14,216 |
|
|
|
— |
|
Provision for income taxes (5) |
|
|
304 |
|
|
|
— |
|
|
|
830 |
|
|
|
— |
|
Total non-GAAP adjustments |
|
$ |
25,854 |
|
|
$ |
7,654 |
|
|
$ |
106,608 |
|
|
$ |
31,280 |
|
Non-GAAP adjusted income
(loss) |
|
$ |
32,812 |
|
|
$ |
5,453 |
|
|
$ |
133,360 |
|
|
$ |
8,558 |
|
(1) Represents stock-based
compensation expense associated with our stock option, restricted
stock unit and performance stock unit grants and our employee share
purchase plan. (2) Represents amortization expense from the Nucynta
Intangible Asset.(3) Represents non-cash interest expense
recognized related to the accretion of debt discount and
amortization of debt issuance costs.(4) Represents non-recurring
adjustment for royalty expense recognized in 2020 prior to the
closing of the Nucynta Asset Purchase Agreement in February 2020.
The royalty expense was included as a reduction to the base
purchase price for the Nucynta Asset Purchase Agreement and, upon
closing, the Company was discharged of any unpaid royalties due to
Assertio.(5) Represents current provision for estimated income
taxes.
Collegium Pharmaceutical,
Inc.
Reconciliation of GAAP Net Income (Loss)
to Adjusted EBITDA(in thousands, except per share
amounts)(unaudited)
|
|
Three months ended |
|
Year ended |
|
|
December 31, |
|
December 31, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
GAAP net income (loss) |
|
$ |
6,958 |
|
|
$ |
(2,201 |
) |
|
$ |
26,752 |
|
|
$ |
(22,722 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
7,737 |
|
|
|
211 |
|
|
|
28,882 |
|
|
|
909 |
|
Interest income |
|
|
(3 |
) |
|
|
(383 |
) |
|
|
(232 |
) |
|
|
(1,935 |
) |
Provision for income taxes |
|
|
304 |
|
|
|
— |
|
|
|
830 |
|
|
|
— |
|
Depreciation |
|
|
281 |
|
|
|
196 |
|
|
|
870 |
|
|
|
731 |
|
Amortization |
|
|
16,795 |
|
|
|
3,688 |
|
|
|
60,680 |
|
|
|
14,752 |
|
Stock-based compensation expense |
|
|
6,210 |
|
|
|
3,966 |
|
|
|
21,910 |
|
|
|
16,528 |
|
Total adjustments |
|
$ |
31,324 |
|
|
$ |
7,678 |
|
|
$ |
112,940 |
|
|
$ |
30,985 |
|
Adjusted EBITDA |
|
$ |
38,282 |
|
|
$ |
5,477 |
|
|
$ |
139,692 |
|
|
$ |
8,263 |
|
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