Collegium Reports Third Quarter 2019 Financial Results
November 06 2019 - 4:01PM
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
quarter ended September 30, 2019 and provided a corporate
update.
“Driven by strong Xtampza ER revenue growth and a commitment to
leveraging our existing cost structure, we are on track to make
2019 a breakthrough year for Collegium,” said Joe Ciaffoni,
President and Chief Executive Officer of Collegium. “Effective
January 1, 2020, Xtampza ER will become the exclusive
extended-release oxycodone for more than 35 million additional
lives. These payer wins will drive the next stage of growth for
Xtampza ER.”
Recent Business Highlights
- Xtampza ER formulary access continues to strengthen: As of
January 1, 2020, Xtampza ER will move into an exclusive formulary
position across 15 plans covering more than 35 million lives. With
the addition of these new exclusive ER oxycodone formulary
positions, Xtampza ER will be the exclusive branded ER oxycodone
for more than 85 million lives.
- Xtampza ER total prescriptions grew to 120,409 in the third
quarter of 2019. Through the first three quarters of 2019,
prescriptions grew 44% over the prior year period, and 3% compared
to the second quarter of 2019.
- Strengthened management team with the appointment of Bart Dunn
to the role of Executive Vice President, Strategy and Corporate
Development.
Leading with the Science
- Collegium had a strong presence at the 13th Annual PAINWeek
National Conference which took place in Las Vegas in September
2019. Four poster presentations that span Collegium’s product
portfolio were presented during the conference.
- A manuscript about Nucynta ER titled, “Evaluation of Abuse and
Route of Administration of Extended-Release Tapentadol Among
Treatment-Seeking Individuals, as Captured by the Addiction
Severity Index–Multimedia Version (ASI-MV)” was recently published
in the online journal Pain Medicine.
Financial Results for Quarter Ended September 30,
2019
- Xtampza ER net product revenues were $26.5 million for the
quarter ended September 30, 2019 (the “2019 Quarter”), compared to
$17.0 million for the quarter ended September 30, 2018 (the “2018
Quarter”) and $26.0 million for the quarter ended June 30, 2019,
representing an increase of 56% and 2%, respectively.
- Nucynta franchise net product revenues were $46.4 million in
the 2019 Quarter, compared to $53.1 million for the 2018 Quarter
and $49.0 million for the quarter ended June 30, 2019, representing
a decrease of 13% and 5%, respectively.
- Selling, general and administrative expenses were $30.1 million
for the 2019 Quarter, compared to $33.4 million for the 2018
Quarter.
- Net loss for the 2019 Quarter was $6.1 million, or $0.18 per
share (basic and diluted), compared to net loss of $16.5 million,
or $0.50 per share (basic and diluted), for the 2018 Quarter. Net
loss included stock-based compensation expense of $4.1 million and
$3.9 million for the 2019 Quarter and 2018 Quarter,
respectively.
- Non-GAAP adjusted income for the 2019 Quarter was $1.7 million,
compared to a non-GAAP adjusted loss of $8.3 million for the 2018
Quarter.
- Collegium had cash and cash equivalents of $153.8 million as of
September 30, 2019, an increase of $5.1 million compared to the
second quarter of 2019. The increase in cash and cash
equivalents was primarily the result of cash provided by operating
activities, partially offset by capital expenditures related to the
buildout of additional manufacturing capacity.
Conference Call Information
Collegium will host a conference call and live audio webcast on
Wednesday, November 6, 2019 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: 958-8674. 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 internally 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. The
Non-GAAP financial measure 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 for the Nucynta intangible asset, non-cash interest expense
recognized on the Nucynta minimum royalty payments, 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.
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. Such statements are subject to numerous important
factors, risks and uncertainties that may cause actual events or
results 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 ability to obtain and maintain regulatory
approval of our products and product candidates; our ability to
effectively commercialize in-licensed products and manage our
relationships with licensors; the success of competing products
that are or become available; 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 outcome of any patent infringement 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 product candidates and manufacture adequate supplies
of 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; 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 Quarterly Report on Form 10-Q for the quarter ended
September 30, 2019, and in other reports which we file 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) |
|
September 30, |
|
December 31, |
|
2019 |
|
2018 |
Cash and cash equivalents |
$ |
153,838 |
|
$ |
146,633 |
Accounts receivable |
|
84,380 |
|
|
77,946 |
Inventory |
|
8,760 |
|
|
7,817 |
Prepaid expenses and other
current assets |
|
2,807 |
|
|
5,116 |
Property and equipment,
net |
|
11,579 |
|
|
9,274 |
Operating lease assets |
|
9,219 |
|
|
— |
Intangible assets, net |
|
33,191 |
|
|
44,255 |
Other noncurrent assets |
|
204 |
|
|
204 |
Total
assets |
$ |
303,978 |
|
$ |
291,245 |
|
|
|
|
Accounts payable and accrued
expenses |
$ |
32,595 |
|
$ |
42,701 |
Accrued rebates, returns and
discounts |
|
165,263 |
|
|
144,783 |
Term loan payable |
|
11,500 |
|
|
11,500 |
Operating lease
liabilities |
|
10,362 |
|
|
— |
Other noncurrent
liabilities |
|
— |
|
|
676 |
Stockholders’ equity |
|
84,258 |
|
|
91,585 |
Total liabilities and
stockholders’ equity |
$ |
303,978 |
|
$ |
291,245 |
|
|
|
|
|
|
|
|
|
|
|
|
Collegium Pharmaceutical,
Inc.
Unaudited Condensed Statements of
Operations(in thousands, except share and per share
amounts)
|
|
Three months ended September 30, |
|
Nine months ended September
30 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Product revenues, net |
|
$ |
72,942 |
|
|
$ |
70,176 |
|
|
$ |
222,498 |
|
|
$ |
206,986 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
|
46,754 |
|
|
|
46,007 |
|
|
|
144,572 |
|
|
|
135,951 |
|
Research and development |
|
|
2,491 |
|
|
|
1,907 |
|
|
|
7,942 |
|
|
|
6,412 |
|
Selling, general and administrative |
|
|
30,072 |
|
|
|
33,448 |
|
|
|
91,359 |
|
|
|
96,309 |
|
Total costs and expenses |
|
|
79,317 |
|
|
|
81,362 |
|
|
|
243,873 |
|
|
|
238,672 |
|
Loss from operations |
|
|
(6,375 |
) |
|
|
(11,186 |
) |
|
|
(21,375 |
) |
|
|
(31,686 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(228 |
) |
|
|
(5,868 |
) |
|
|
(698 |
) |
|
|
(17,726 |
) |
Interest income |
|
|
494 |
|
|
|
552 |
|
|
|
1,552 |
|
|
|
1,198 |
|
Net loss |
|
$ |
(6,109 |
) |
|
$ |
(16,502 |
) |
|
$ |
(20,521 |
) |
|
$ |
(48,214 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share–basic and
diluted |
|
$ |
(0.18 |
) |
|
$ |
(0.50 |
) |
|
$ |
(0.62 |
) |
|
$ |
(1.46 |
) |
Weighted-average shares -basic
and diluted |
|
|
33,481,923 |
|
|
|
33,012,174 |
|
|
|
33,360,272 |
|
|
|
32,950,584 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP Financial
Information |
(in thousands, except per share amounts) |
(unaudited) |
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
GAAP net loss |
|
$ |
(6,109 |
) |
|
$ |
(16,502 |
) |
|
$ |
(20,521 |
) |
|
$ |
(48,214 |
) |
Non-GAAP
adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
4,137 |
|
|
|
3,926 |
|
|
|
12,562 |
|
|
|
10,180 |
|
Nucynta
related amortization expense (1) |
|
|
3,688 |
|
|
|
32,407 |
|
|
|
11,064 |
|
|
|
94,340 |
|
Nucynta
non-cash interest expense (2) |
|
|
— |
|
|
|
5,641 |
|
|
|
— |
|
|
|
17,112 |
|
Nucynta
minimum royalty payment due (3) |
|
|
— |
|
|
|
(33,750 |
) |
|
|
— |
|
|
|
(98,250 |
) |
Total non-GAAP adjustments |
|
$ |
7,825 |
|
|
$ |
8,224 |
|
|
$ |
23,626 |
|
|
$ |
23,382 |
|
Non-GAAP adjusted
income (loss) |
|
$ |
1,716 |
|
|
$ |
(8,278 |
) |
|
$ |
3,105 |
|
|
$ |
(24,832 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
Second Quarter |
|
Third Quarter |
|
|
|
|
|
2019 |
|
2019 |
|
|
2019 |
|
|
|
|
GAAP net
loss |
|
$ |
(9,700 |
) |
|
$ |
(4,712 |
) |
|
$ |
(6,109 |
) |
|
|
|
Non-GAAP
adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense |
|
|
4,263 |
|
|
|
4,162 |
|
|
|
4,137 |
|
|
|
|
Nucynta
related amortization expense (1) |
|
|
3,688 |
|
|
|
3,688 |
|
|
|
3,688 |
|
|
|
|
Nucynta
non-cash interest expense (2) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
Nucynta
minimum royalty payment due (3) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
Total non-GAAP adjustments |
|
$ |
7,951 |
|
|
$ |
7,850 |
|
|
$ |
7,825 |
|
|
|
|
Non-GAAP adjusted income (loss) |
|
$ |
(1,749 |
) |
|
$ |
3,138 |
|
|
$ |
1,716 |
|
|
|
|
|
|
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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