Collegium Provides Full-Year 2019 Financial Guidance
January 07 2019 - 8:00AM
– Xtampza ER Revenue Expected in the Range of $95
Million to $105 Million
Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty
pharmaceutical company committed to being the leader in responsible
pain management today provided full-year 2019 guidance for Xtampza
ER revenues, Nucynta Franchise revenues, and total operating
expenses.
“With strong growth for Xtampza ER in 2018 and the
addition of the Nucynta Franchise, Collegium built a solid
foundation upon which to progress in the year ahead,” said Joe
Ciaffoni, Chief Executive Officer. “Our 2019 revenue guidance
reflects the anticipated impact of recently announced formulary
wins for Xtampza ER as well as stabilization of the Nucynta
franchise.”
Xtampza ER revenue for 2019 is estimated to be between $95
million and $105 million. Driven by thirteen exclusive Xtampza ER
formulary wins that were recently announced, covering approximately
11 million lives, revenue growth is anticipated to be skewed to the
first half of 2019, with moderated growth in the second half of
2019.
Nucynta Franchise revenue for 2019 is estimated to be between
$200 million and $210 million. Nucynta Franchise revenue guidance
reflects the Company’s expectations for continued prescription
stabilization in 2019.
Total operating expenses for 2019 are expected to be between
$125 million and $135 million. This includes Research &
Development and Selling, General & Administrative expenses, but
not the cost of product revenues.
The Company made its corporate presentation available on Form
8-K, filed today with the Securities and Exchange Commission.
About Collegium Pharmaceutical,
Inc.
Collegium Pharmaceutical is a specialty pharmaceutical company
committed to being the leader in responsible pain
management.
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,” “forecasts,” “plans,” “intends,” “may,”
“could,” “might,” “should” or other words that convey uncertainty
of future events or outcomes to identify these forward-looking
statements. These forward-looking statements include statements
regarding full-year 2019 guidance for Xtampza ER and Nucynta
Franchise revenues and total operating expense.
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, including the
following: our ability to maintain regulatory approval of our
products, and any related restrictions, limitations, and/or
warnings in the label of an approved product; our plans to
commercialize and grow sales of our products; 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 and maintain
reimbursement and third-party payor contracts for our products; the
rate and degree of market acceptance of our products; changing
market conditions for our products; 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.; regulatory developments impacting our
products and market; our expectations regarding our ability to
obtain and 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; our ability to
comply with stringent 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; 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 September 30,
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 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
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