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, 2019 and provided a
corporate update.
“In 2019 we delivered record revenue and achieved non-GAAP
profitability for three consecutive quarters,” said Joe Ciaffoni,
President and Chief Executive Officer of Collegium. “Driven by
Xtampza ER growth and the acquisition of the Nucynta Franchise,
2020 will be a financially transformative year for Collegium.”
Recent Business Highlights
- Xtampza ER total prescriptions grew to 124,067 in the fourth
quarter of 2019, representing a 37% increase over the fourth
quarter of 2018. For the full year, total prescriptions for Xtampza
ER grew 49%, reaching 466,378, compared to 313,152 total
prescriptions in 2018.
- The Company secured 20 new exclusive ER oxycodone formulary
wins covering more than 35 million lives for Xtampza ER, which took
effect January 1, 2020. With these wins, Collegium is the exclusive
ER oxycodone for approximately 40% of Commercial and Part D covered
lives. Xtampza ER continues to have broad-based coverage, including
95% coverage of Commercial lives and 50% coverage of Part D
lives.
- The Company announced on February 13, 2020 it closed the
acquisition of the U.S. rights to the Nucynta Franchise from
Assertio Therapeutics, Inc.
Financial Guidance for 2020
The Company reiterates its full-year 2020 financial guidance,
initially provided on January 7, 2020:
- Xtampza ER revenues are expected in the range of $150.0 million
to $160.0 million.
- Nucynta Franchise revenues are expected in the range of $170.0
million to $180.0 million.
- Total operating expenses are expected in the range of $130.0
million to $140.0 million.
In addition, the Company provides the following full-year 2020
financial guidance:
- Non-GAAP adjusted income is expected in the range of $125.0
million to $140.0 million
Financial Results for Quarter Ended December 31,
2019
- Xtampza ER net product revenues were $27.4 million for the
quarter ended December 31, 2019 (the “2019 Quarter”), compared to
$18.4 million for the quarter ended December 31, 2018 (the “2018
Quarter”) and $26.5 million for the quarter ended September 30,
2019, representing an increase of 49% and 3%, respectively.
- Nucynta franchise net product revenues were $46.8 million in
the 2019 Quarter, compared to $55.0 million for the 2018 Quarter
and $46.5 million for the quarter ended September 30, 2019,
representing a decrease of 15% and increase of 1%,
respectively.
- Operating expenses were $27.5 million for the 2019 Quarter,
compared to $32.7 million for the 2018 Quarter.
- Net loss for the 2019 Quarter was $2.2 million, or $0.07 loss
per share (basic and diluted), compared to net income of $9.1
million, or $0.27 income per share (basic and diluted), for the
2018 Quarter. Net loss included stock-based compensation expense of
$4.0 million and $3.6 million for the 2019 Quarter and 2018
Quarter, respectively.
- Non-GAAP adjusted income for the 2019 Quarter was $5.5 million,
compared to a non-GAAP adjusted loss of $3.4 million for the 2018
Quarter.
Full-Year 2019 Financial Highlights
- For the year ended December 31, 2019, total net product
revenues were $296.7 million, which included Xtampza ER net
revenues of $105.0 million and Nucynta franchise net revenues of
$191.7 million. This compared to total net product revenues of
$280.4 million for the year ended December 31, 2018, which included
Xtampza ER net revenues of $69.4 million and Nucynta franchise net
revenues of $211.0 million.
- Operating expenses for the year ended December 31, 2019 were
$126.8 million, compared to $135.4 million for the year ended
December 31, 2018. The decrease was primarily related to a decrease
in sales, marketing and consulting costs of $8.1 million, primarily
due to higher one-time costs incurred in 2018 to commercialize the
Nucynta franchise.
- Net loss for the year ended December 31, 2019 was $22.7
million, or $0.68 per share (basic and diluted), compared to a net
loss of $39.1 million, or $1.19 per share (basic and diluted) for
the year ended December 31, 2018.
- Non-GAAP adjusted income for the year ended December 31, 2019
was $8.6 million. This compared to a non-GAAP adjusted loss of
$28.2 million for the year ended December 31, 2018.
- The Company had cash and cash equivalents of $170.0 million at
December 31, 2019,
Conference Call Information
The Company will host a conference call and live audio webcast
on Thursday, February 27, 2020 at 4:30 p.m. Eastern Time. To access
the conference call, please dial (888) 698-6931 (U.S.) or (805)
905-2993 (International) and refer to Conference ID: 829-8360. 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).
We use this non-GAAP financial measure to understand, manage and
evaluate the Company as we believe it represents the performance of
our core business. Because this non-GAAP financial measure is an
important internal measure for the Company, we believe that the
presentation of the non-GAAP financial measure provides analysts,
investors and lenders insight into management’s view and assessment
of the Company’s ongoing operating performance. In addition, we
believe that the presentation of this non-GAAP financial measure,
when viewed with our results under GAAP and the accompanying
reconciliation, 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 this non-GAAP financial measure in order to
portray the results of our major operations – commercializing
innovative, differentiated products for people suffering from pain
– prior to considering certain income statement elements. This
non-GAAP financial measure should be considered in addition to, and
not 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.
The Company has not provided a reconciliation of its full-year
2020 guidance for non-GAAP adjusted income (loss) 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 such a reconciliation.
These items are uncertain and depend on various factors that could
have a material impact on GAAP net income (loss) 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,
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 our expectations related to the potential impact
of the Nucynta acquisition on our future operating results; 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. and Teva
Pharmaceuticals USA, Inc.; the outcome of any governmental
investigation related to the manufacture, marketing and sale of
opioid medications; 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 for the year ended December 31, 2019 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 adasalla@collegiumpharma.com
Collegium Pharmaceutical,
Inc.
Unaudited Selected Consolidated Balance
Sheet Information(in thousands)
|
December 31, |
|
|
2019 |
|
|
2018 |
Cash and cash equivalents |
$170,019 |
|
$146,633 |
Accounts receivable |
|
72,953 |
|
|
77,946 |
Inventory |
|
9,643 |
|
|
7,817 |
Prepaid expenses and other current assets |
|
3,105 |
|
|
5,116 |
Property and equipment, net |
|
11,854 |
|
|
9,274 |
Operating lease assets |
|
9,047 |
|
|
— |
Intangible assets, net |
|
29,503 |
|
|
44,255 |
Other noncurrent assets |
|
178 |
|
|
204 |
Total assets |
$306,302 |
|
$291,245 |
|
|
|
|
Accounts payable and accrued expenses |
|
39,727 |
|
$42,701 |
Accrued rebates, returns and discounts |
|
157,549 |
|
|
144,783 |
Term loan payable |
|
11,500 |
|
|
11,500 |
Operating lease liabilities |
|
10,094 |
|
|
— |
Other noncurrent liabilities |
|
— |
|
|
676 |
Stockholders’ equity |
|
87,432 |
|
|
91,585 |
Total liabilities and
stockholders’ equity |
$306,302 |
|
$291,245 |
|
|
|
|
Collegium Pharmaceutical,
Inc.
Unaudited Condensed Statements of
Operations(in thousands, except share and per share
amounts)
|
Three months ended December 31, |
|
Years ended December 31, |
|
|
2019 |
|
|
2018(1) |
|
|
2019 |
|
|
|
2018 |
|
Product revenues, net |
$74,203 |
|
|
$73,427 |
|
|
$296,701 |
|
|
$280,413 |
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
Cost of product revenues |
|
49,088 |
|
|
|
29,726 |
|
|
|
193,660 |
|
|
|
165,677 |
|
Research and development |
|
2,398 |
|
|
|
2,249 |
|
|
|
10,340 |
|
|
|
8,661 |
|
Selling, general and administrative |
|
25,090 |
|
|
|
30,451 |
|
|
|
116,449 |
|
|
|
126,760 |
|
Total costs and expenses |
|
76,576 |
|
|
|
62,426 |
|
|
|
320,449 |
|
|
|
301,098 |
|
Loss from operations |
|
(2,373) |
|
|
|
11,001 |
|
|
|
(23,748) |
|
|
|
(20,685) |
|
|
|
|
|
|
|
|
|
Interest expense |
|
(211) |
|
|
|
(2,404) |
|
|
|
(909) |
|
|
|
(20,130) |
|
Interest income |
|
383 |
|
|
|
489 |
|
|
|
1,935 |
|
|
|
1,687 |
|
Net loss |
$(2,201) |
|
|
$9,086 |
|
|
$(22,722) |
|
|
$(39,128) |
|
|
|
|
|
|
|
|
|
(Loss) Earnings per share - basic |
$(0.07) |
|
|
$0.27 |
|
|
$(0.68) |
|
|
$(1.19) |
|
Weighted-average shares - basic |
|
33,600,566 |
|
|
|
33,250,180 |
|
|
|
33,453,844 |
|
|
|
32,953,808 |
|
|
|
|
|
|
|
|
|
(Loss) Earnings per share -
diluted |
$(0.07) |
|
|
$0.27 |
|
|
$(0.68) |
|
|
$(1.19) |
|
Weighted-average shares -
diluted |
|
33,600,566 |
|
|
|
33,769,765 |
|
|
|
33,453,844 |
|
|
|
32,953,808 |
|
|
|
|
|
|
|
|
|
(1) - In the fourth quarter of 2018, the
Company executed the Third Amendment to the Nucynta
Commercialization Agreement, which eliminated the guaranteed
minimum royalty payment obligations after 2018. As a result, the
Company remeasured the remaining contractual obligation as of the
Amendment Date and reduced the intangible asset. Consequently,
amortization expense included within cost of product revenues was
$15,494 in the fourth quarter compared to $32,407, $32,407 and
$29,526 in the third, second and first quarters, respectively.
Similarly, interest expense associated with the minimum royalty
payments was $2,169 in the fourth quarter compared to $5,641,
$5,943 and $5,528 in the third, second and first quarters,
respectively. For further detail, please refer to our annual report
on form 10-K.
|
|
Reconciliation of GAAP to Non-GAAP Financial
Information |
(in
thousands, except per share amounts) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
Years
ended |
|
December
31, |
|
December
31, |
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
GAAP net income (loss) |
$ |
(2,201) |
|
|
$ |
9,086 |
|
|
$ |
(22,722) |
|
|
$ |
(39,128) |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
expense |
|
3,966 |
|
|
|
3,598 |
|
|
|
16,528 |
|
|
|
13,778 |
|
Nucynta related amortization
expense (1) |
|
3,688 |
|
|
|
15,494 |
|
|
|
14,752 |
|
|
|
109,834 |
|
Nucynta non-cash interest expense
(2) |
|
— |
|
|
|
2,169 |
|
|
|
— |
|
|
|
19,281 |
|
Nucynta minimum royalty payment
due (3) |
|
— |
|
|
|
(33,750) |
|
|
|
— |
|
|
|
(132,000) |
|
Total non-GAAP adjustments |
$ |
7,654 |
|
|
$ |
(12,489) |
|
|
$ |
31,280 |
|
|
$ |
10,893 |
|
Non-GAAP adjusted income (loss) |
$ |
5,453 |
|
|
$ |
(3,403) |
|
|
$ |
8,558 |
|
|
$ |
(28,235) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First
Quarter |
|
Second
Quarter |
|
Third
Quarter |
|
Fourth
Quarter |
|
2019 |
|
|
2019 |
|
|
2019 |
|
|
2019 |
|
GAAP net loss |
$ |
(9,700) |
|
|
$ |
(4,712) |
|
|
$ |
(6,109) |
|
|
$ |
(2,201) |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
expense |
|
4,263 |
|
|
|
4,162 |
|
|
|
4,137 |
|
|
|
3,966 |
|
Nucynta related amortization
expense (1) |
|
3,688 |
|
|
|
3,688 |
|
|
|
3,688 |
|
|
|
3,688 |
|
Total non-GAAP adjustments |
$ |
7,951 |
|
|
$ |
7,850 |
|
|
$ |
7,825 |
|
|
$ |
7,654 |
|
Non-GAAP adjusted income
(loss) |
$ |
(1,749) |
|
|
$ |
3,138 |
|
|
$ |
1,716 |
|
|
$ |
5,453 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First
Quarter |
|
Second
Quarter |
|
Third Quarter |
|
Fourth Quarter |
|
2018 |
|
|
2018 |
|
|
2018 |
|
|
2018 |
|
GAAP net income (loss) |
$ |
(18,652) |
|
|
$ |
(13,060) |
|
|
$ |
(16,502) |
|
|
$ |
9,086 |
|
Non-GAAP adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
expense |
|
2,728 |
|
|
|
3,526 |
|
|
|
3,926 |
|
|
|
3,598 |
|
Nucynta related amortization
expense (1) |
|
29,526 |
|
|
|
32,407 |
|
|
|
32,407 |
|
|
|
15,494 |
|
Nucynta non-cash interest expense
(2) |
|
5,528 |
|
|
|
5,943 |
|
|
|
5,641 |
|
|
|
2,169 |
|
Nucynta minimum royalty payment
due (3) |
|
(30,750) |
|
|
|
(33,750) |
|
|
|
(33,750) |
|
|
|
(33,750) |
|
Total non-GAAP adjustments |
$ |
7,032 |
|
|
$ |
8,126 |
|
|
$ |
8,224 |
|
|
$ |
(12,489) |
|
Non-GAAP adjusted loss |
$ |
(11,620) |
|
|
$ |
(4,934) |
|
|
$ |
(8,278) |
|
|
$ |
(3,403) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Represents amortization expense of the Nucynta Intangible
Asset. |
(2) Represents non-cash interest expense associated with the
minimum royalty payments of the Nucynta Commercialization
Agreement. |
(3) Represents minimum royalty payment due and payable in
connection with the Nucynta Commercialization Agreement. |
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