Collegium Reports First Quarter 2019 Financial Results
May 08 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 first
quarter ended March 31, 2019 and provided a corporate update.
“In the first quarter of 2019, we were encouraged by the
acceleration of Xtampza ER, driven by 13 new exclusive ER oxycodone
payer wins that took effect January 1, 2019,” said Joe Ciaffoni,
President and Chief Executive Officer of Collegium. “For the
remainder of 2019, we remain focused on growing Xtampza ER,
maximizing the value of the Nucynta franchise and executing our
mid-term growth strategy. Collegium is well positioned to become
the leader in responsible pain management.”
Recent Business Highlights
- In the first quarter of 2019, Xtampza ER reached over 100,000
total prescriptions in a quarter for the first time since launch.
Total prescriptions for Xtampza ER grew to 105,309 in the first
quarter of 2019, representing a 71% increase over the first quarter
of 2018 and 16% growth on a consecutive-quarter basis.
- The number of unique Xtampza ER prescribers grew to 12,333 in
the first quarter of 2019, a 21% increase on a consecutive-quarter
basis.
- In the first quarter of 2019, a new patent covering Xtampza ER
was added to the FDA Orange Book, with an expiry date in 2036. With
this recent addition to the patent estate, Xtampza ER is now
covered by 15 Orange Book listed patents.
- In April 2019, Collegium expanded its leadership team with the
appointment of Richard Malamut, M.D. as the company’s Chief Medical
Officer overseeing Collegium’s Clinical Development, Medical
Affairs, Regulatory and Scientific Affairs functions.
Financial Results for Quarter Ended March 31,
2019
- For the quarter ended March 31, 2019 (the “2019 Quarter”),
total net product revenues were $74.5 million, which included
Xtampza ER net product revenues of $25.1 million and Nucynta
franchise net product revenues of $49.4 million. This compared to
total net product revenues of $63.7 million for the quarter ended
March 31, 2018 (the “2018 Quarter”), which included $15.8 million
for Xtampza ER and $48.0 million for the Nucynta franchise.
- Research and development expenses were $3.0 million for the
2019 Quarter compared to $2.3 million for the 2018 Quarter. The
increase was primarily related to an increase in employee-related
expenses, including stock-based compensation expense.
- Selling, general and administrative expenses were $32.4 million
for the 2019 Quarter, compared to $31.6 million for the 2018
Quarter. The increase was primarily related to an increase in our
sales and marketing costs associated with Xtampza ER and the
Nucynta franchise, increased professional fees and an increase in
stock-based compensation, offset by lower regulatory-related
costs.
- Net loss for the 2019 Quarter was $9.7 million, or $0.29 per
share (basic and diluted), compared to net loss of $18.7 million,
or $0.57 per share (basic and diluted), for the 2018 Quarter. Net
loss included stock-based compensation expense of $4.3 million and
$2.7 million for the 2019 Quarter and 2018 Quarter,
respectively.
- Non-GAAP adjusted loss for the 2019 Quarter was $1.7 million.
This compared to a non-GAAP adjusted loss of $11.6 million for the
2018 Quarter.
- Collegium had cash and cash equivalents of $134.9 million as of
March 31, 2019, compared to $146.6 million as of December 31,
2018. The decrease from the prior quarter was the result of
lower cash receipts due to the extension of payment terms for a
major wholesaler, as well as 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, May 8, 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: 419-0474. An
audio webcast will be accessible from the Investor Relations
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 U.S.
generally accepted accounting principles, or GAAP, basis, we have
included information about non-GAAP adjusted loss. 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
internally use non-GAAP adjusted loss to understand, manage and
evaluate the Company as we believe it represents the performance of
our core business. 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 loss is not based on any standardized
methodology prescribed by GAAP and represents GAAP net 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 to Assertio in connection with the
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.
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.; our ability to
secure adequate supplies of active pharmaceutical ingredient for
each of our products and product candidates; 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 Annual Report on Form 10-K
for the year ended December 31, 2018, 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 Dasalla adasalla@collegiumpharma.com
Collegium Pharmaceutical,
Inc.
Unaudited Selected Consolidated Balance
Sheet Information(in thousands)
|
March 31, |
|
December 31, |
|
2019 |
|
2018 |
Cash and cash
equivalents |
$ |
134,910 |
|
$ |
146,633 |
Accounts receivable |
|
85,139 |
|
|
77,946 |
Inventory |
|
8,741 |
|
|
7,817 |
Prepaid expenses and other current assets |
|
5,053 |
|
|
5,116 |
Property and equipment, net |
|
9,962 |
|
|
9,274 |
Operating lease assets |
|
9,766 |
|
|
— |
Intangible assets, net |
|
40,567 |
|
|
44,255 |
Other long-term assets |
|
224 |
|
|
204 |
Total assets |
$ |
294,362 |
|
$ |
291,245 |
|
|
|
|
Accounts payable and accrued expenses |
$ |
33,570 |
|
$ |
42,701 |
Accrued rebates, returns and discounts |
|
152,328 |
|
|
144,783 |
Term loan payable |
|
11,500 |
|
|
11,500 |
Operating lease liabilities |
|
10,614 |
|
|
— |
Other liabilities |
|
— |
|
|
676 |
Stockholders’ equity |
|
86,350 |
|
|
91,585 |
Total liabilities and
stockholders’ equity |
$ |
294,362 |
|
$ |
291,245 |
|
|
|
|
|
|
Collegium Pharmaceutical,
Inc.
Unaudited Condensed Statements of
Operations(in thousands, except share and per share
amounts)
|
Three months ended March 31, |
|
2019 |
|
2018 |
Product
revenues, net |
$ |
74,516 |
|
|
$ |
63,749 |
|
|
|
|
|
Costs and expenses: |
|
|
|
Cost of product revenues |
|
49,164 |
|
|
|
43,106 |
|
Research and development |
|
2,992 |
|
|
|
2,268 |
|
Selling, general and administrative |
|
32,352 |
|
|
|
31,582 |
|
Total costs and expenses |
|
84,508 |
|
|
|
76,956 |
|
Loss from operations |
|
(9,992 |
) |
|
|
(13,207 |
) |
|
|
|
|
Interest expense |
|
(234 |
) |
|
|
(5,700 |
) |
Interest income |
|
526 |
|
|
|
255 |
|
Net loss |
$ |
(9,700 |
) |
|
$ |
(18,652 |
) |
|
|
|
|
Loss per share – basic and diluted |
$ |
(0.29 |
) |
|
$ |
(0.57 |
) |
Weighted-average shares – basic and diluted |
|
33,331,917 |
|
|
|
32,903,674 |
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP
Financial Information(in thousands, except per share
amounts)(unaudited)
|
Three months
ended March 31, |
|
2019 |
|
2018 |
|
|
|
|
GAAP net
loss |
$ |
(9,700 |
) |
|
$ |
(18,652 |
) |
Non-GAAP adjustments: |
|
|
|
|
|
Stock-based compensation expense |
|
4,263 |
|
|
|
2,728 |
|
Nucynta related amortization expense (1) |
|
3,688 |
|
|
|
29,526 |
|
Nucynta non-cash interest expense (2) |
|
— |
|
|
|
5,528 |
|
Nucynta minimum royalty payment due (3) |
|
— |
|
|
|
(30,750 |
) |
Total non-GAAP adjustments |
$ |
7,951 |
|
|
$ |
7,032 |
|
Non-GAAP adjusted loss |
$ |
(1,749 |
) |
|
$ |
(11,620 |
) |
|
|
|
|
|
|
|
|
Explanation of Adjustments: |
|
|
|
|
|
|
|
|
|
|
(1) Represents amortization expense
of the Nucynta intangible asset. |
(2) Represents non-cash interest
expense recognized related to the Nucynta minimum royalty
payments. |
(3) Represents minimum royalty
payment due and payable in connection with the Nucynta
Commercialization Agreement. |
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