Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today reported its
financial results for the first quarter of 2018 and provided a
corporate update.
“Our significant growth in the first quarter is a step forward
in our evolution to becoming a leader in responsible pain
management as we strive to bring innovative treatment options to
the pain market,” said Michael Heffernan, Chief Executive Officer
of Collegium.
“In the first quarter of 2018, we were encouraged by the
continued adoption of Xtampza ER by clinicians and payers,” said
Joe Ciaffoni, Chief Operating Officer of Collegium. “As we
integrate the Nucynta franchise into our product portfolio, we are
committed to providing comprehensive pain management options to
people suffering with pain.”
Recent Milestones
Commercial
- Prescriptions for Xtampza ER grew to 65,367 in the first
quarter of 2018, a 72% increase over the fourth quarter of
2017.
- Prescribers of Xtampza ER grew to 10,786 since launch,
including 3,886 new prescribers in the first quarter of 2018.
- Continued to strengthen formulary access for Xtampza ER.
- Made significant progress in Phase I of the Nucynta integration
plan focused on transitioning and stabilizing the franchise. The
transaction closed on January 9, 2018 and Collegium began promotion
of the Nucynta franchise in mid-February 2018. All 5 strengths of
Nucynta ER were available in late-March 2018, for the first time
since the supply disruption in September 2017. As integration of
the Nucynta franchise into the commercial organization continues,
there are signs of stabilization.
Corporate
- Strengthened leadership team with the addition of Shirley
Kuhlmann, Executive Vice President and General Counsel and
Secretary, with responsibility for our legal and compliance
functions. Prior to joining Collegium, Ms. Kuhlmann was a Partner
in the Health Sciences Department of Pepper Hamilton LLP, where she
served as Collegium’s outside counsel.
Regulatory
- Recently, we received an Issue Notification from the United
States Patent and Trademark Office for a new patent covering
Xtampza ER. Once issued, the new patent will be added to the FDA
Orange Book and provides additional patent protection for Xtampza
ER until 2036.
First Quarter 2018 Financial
Results
Net Product Revenues were $63.7 million for the
quarter ended March 31, 2018 (the “2018 Quarter”) compared to $2.2
million for the quarter ended March 31, 2017 (the “2017 Quarter”).
In the 2018 Quarter, net product revenue was $15.8 million for
Xtampza and $47.9 million for the Nucynta franchise.
Net loss for the 2018 Quarter was $18.7 million, or $0.57 per
share (basic and diluted), as compared to net loss of $23.1
million, or $0.79 per share (basic and diluted), for the 2017
Quarter. Net loss includes stock-based compensation expense
of $2.7 million and $1.8 million for the 2018 Quarter and 2017
Quarter, respectively. Net loss for the 2018 Quarter includes a
non-cash interest charge of $5.5 million associated with accounting
for Nucynta.
Research and development expenses were $2.3 million for the 2018
Quarter compared to $2.1 million for the 2017 Quarter. The
increase was primarily related to clinical trial and regulatory
activity.
Selling, general and administrative expenses were $31.6 million
for the 2018 Quarter compared to $22.8 million for the 2017
Quarter. The increase was primarily related to higher
personnel costs of $3.7 million and higher commercialization costs
including consulting and marketing expenses of $3.0 million related
to Nucynta.
Collegium had cash and cash equivalents of $128.2 million as of
March 31, 2018, compared to $118.7 million as of December 31,
2017. Cash provided by operating and investing activities for
the 2018 Quarter was $10.5 million.
As of March 31, 2018, there were 33,027,579 common shares
outstanding.
Financial Outlook
Based on our current operating plans, we believe that our
existing cash resources, together with expected cash inflows from
the commercialization of Xtampza ER and the Nucynta franchise will
fund our operating expenses, debt service and capital expenditure
requirements at least into 2020.
Conference Call Information
Collegium will host a conference call and live audio webcast on
Wednesday, May 9, 2018 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:
799-9797. An audio webcast will be accessible from the
Investor Relations section of the Company’s website:
http://www.collegiumpharma.com/. An archived
webcast will be available on the Company’s website approximately
two hours after the event.
About Collegium Pharmaceutical,
Inc.
Collegium is a specialty pharmaceutical company focused on
becoming the leader in responsible pain management by developing
and commercializing innovative, differentiated products for
patients suffering from pain.
About Xtampza ER
Xtampza® ER is Collegium’s first product utilizing the DETERx
technology platform. Xtampza ER is an abuse-deterrent,
extended-release, oral formulation of oxycodone approved by the FDA
for the management of pain severe enough to require daily,
around-the-clock, long-term opioid treatment and for which
alternative treatment options are inadequate.
About Nucynta ER
Nucynta® ER is an extended release formulation of tapentadol.
Tapentadol is a centrally acting synthetic analgesic. Nucynta ER is
approved by the FDA for the management of pain severe enough to
require daily, around-the-clock, long-term opioid treatment and for
which alternative treatment options are inadequate. Nucynta
ER is also approved by the FDA for neuropathic pain associated with
diabetic peripheral neuropathy severe enough to require daily,
around-the-clock, long-term opioid treatment and for which
alternative treatment options are inadequate.
About Nucynta
Nucynta® is an immediate release formulation of tapentadol
indicated for the management of acute pain severe enough to require
an opioid analgesic. Tapentadol is a centrally acting synthetic
analgesic.
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,”
“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
presentation could also be affected by risks and uncertainties
relating to a number of other factors, including the following: our
ability to obtain and maintain regulatory approval of our products
and product candidates, and any related restrictions, limitations,
and/or warnings in the label of an approved product; our plans to
commercialize our product candidates and grow sales of our
products; our ability to effectively commercialize in-licensed
products and manage our relationships with licensors, including our
ability to satisfy our royalty payment obligations in connection
with such products; the size and growth potential of the markets
for our products and product candidates, and our ability to service
those markets; the success of competing products that are or become
available; our ability to obtain and maintain reimbursement and
third-party payor contracts for our products; the costs of
commercialization activities, including marketing, sales and
distribution; our ability to develop and maintain sales and
marketing capabilities, whether alone or with potential future
collaborators; the rate and degree of market acceptance of our
products and product candidates; changing market conditions for 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 attract collaborators
with development, regulatory and commercialization expertise; the
success, cost and timing of our product development activities,
studies and clinical trials; our ability to obtain funding for our
operations; regulatory developments in the United States and
foreign countries; our expectations regarding our ability to obtain
and adequately maintain sufficient intellectual property protection
for our products and product candidates; our ability to operate our
business without infringing the intellectual property rights of
others; the performance of our third-party suppliers and
manufacturers; 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 regulations relating to the manufacturing and marketing
of pharmaceutical products, including U.S. Drug Enforcement Agency,
or DEA, compliance; the loss of key scientific or management
personnel; our expectations regarding the period during which
we qualify as an emerging growth company under the JOBS Act; our
customer concentration, which may adversely affect our financial
condition and results of operations; and the accuracy of our
estimates regarding expenses, revenue, capital requirements and
need for additional financing. These and other risks, uncertainties
and factors are described under the heading “Risk Factors” in our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2018,
and those risks described from time to time in other reports which
we file with the SEC. Any forward-looking statements that we make
in this presentation speak only as of the date of this
presentation. 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) |
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2018 |
|
|
2017 |
Cash and cash
equivalents |
$ |
128,249 |
|
$ |
118,697 |
Accounts
receivable |
|
66,036 |
|
|
9,969 |
Inventory |
|
7,902 |
|
|
1,813 |
Prepaid expenses and
other current assets |
|
5,526 |
|
|
3,005 |
Property and equipment,
net |
|
1,612 |
|
|
1,826 |
Intangible assets,
net |
|
486,100 |
|
|
— |
Restricted cash |
|
703 |
|
|
97 |
Other long-term
assets |
|
150 |
|
|
161 |
Total
assets |
$ |
696,278 |
|
$ |
135,568 |
|
|
|
|
Accounts payable and
accrued expenses |
$ |
26,772 |
|
$ |
14,225 |
Accrued rebates,
returns and discounts |
|
92,400 |
|
|
15,784 |
Asset acquisition
obligations |
|
474,783 |
|
|
— |
Other liabilities |
|
11,500 |
|
|
1,479 |
Stockholders’
equity |
|
90,823 |
|
|
104,080 |
Total
liabilities and stockholders’ equity |
$ |
696,278 |
|
$ |
135,568 |
|
|
|
|
|
|
|
|
Collegium Pharmaceutical,
Inc.Unaudited Condensed Statements of
Operations(in thousands, except share and per share
amounts) |
|
|
|
Three months ended March 31, |
|
|
2018 |
|
|
|
2017 |
|
Product revenues,
net |
$ |
63,749 |
|
|
$ |
2,172 |
|
|
|
|
|
Costs and
expenses: |
|
|
|
Cost of product
revenues |
|
43,106 |
|
|
|
371 |
|
Research and
development |
|
2,268 |
|
|
|
2,130 |
|
Selling, general and
administrative |
|
31,582 |
|
|
|
22,847 |
|
Total costs and
expenses |
|
76,956 |
|
|
|
25,348 |
|
Loss from
operations |
|
(13,207 |
) |
|
|
(23,176 |
) |
|
|
|
|
Interest expense |
|
(5,700 |
) |
|
|
— |
|
Interest income |
|
255 |
|
|
|
98 |
|
Net
loss |
($ |
18,652 |
) |
|
($ |
23,078 |
) |
|
|
|
|
Loss per share–basic
and diluted |
($ |
0.57 |
) |
|
($ |
0.79 |
) |
Weighted-average shares
-basic and diluted |
|
32,903,674 |
|
|
|
29,350,268 |
|
|
|
|
|
|
|
|
|
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