Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today reported its
financial results for the fourth quarter and year ended December
31, 2017 and provided a corporate update.
“As we strive to establish Collegium as the leader in
responsible pain management, we are encouraged by the success of
Xtampza ER during the fourth quarter of 2017,” said Mike Heffernan,
CEO of Collegium. “Integrating the Nucynta franchise into our pain
portfolio in 2018 will enhance our ability to make a positive
difference in the lives of people suffering from pain.”
“In 2017, our focus on operational execution generated
significant momentum with Xtampza ER,” said Joe Ciaffoni, Chief
Operating Officer of Collegium. “In 2018, the Collegium team is
committed to continuing this focus so that patients who require
opioid pain management can benefit from abuse-deterrent Xtampza ER,
as well as the Nucynta franchise.”
Recent Milestones
Commercial
- Prescriptions for Xtampza ER grew to 38,044 in the fourth
quarter, a 37% increase over the third quarter of 2017.
- Prescribers of Xtampza ER grew to 6,895 since launch, including
1,603 new prescribers in the fourth quarter of 2017.
- Secured new exclusive ER oxycodone formulary wins with numerous
payers, including: Optum Medicare Part D, all Medicare Advantage
and select Medicare PDP plans, Humana Commercial, Navitus
Commercial and UPMC Commercial and Medicare D.
- Addition of the Nucynta franchise to the pain portfolio
establishes Collegium as a leader in responsible pain management.
On January 9, 2018, the transaction closed. Collegium began
promotion of the Nucynta franchise in mid-February 2018.
Corporate
- Strengthened leadership team with the addition of Scott Dreyer,
SVP, Sales, Marketing, Commercial Capabilities and Training. Scott
brings over 24 years of commercial leadership experience across
sales, marketing, commercial operations and strategic planning, all
within the biopharma industry. Scott joins Collegium from The
Medicines Company, where he was the SVP, Marketing and Commercial
Operations.
Clinical
- With the recent approval of our sNDA, the updated Xtampza ER
label, includes:° OxyContin Comparative Data - The
addition of comparative oral pharmacokinetic data, ° Oral
Human Abuse Potential Study - Results of an oral human
abuse potential study comparing intact and manipulated Xtampza ER
to oxycodone IR were added to the label, ° Oral Abuse
Deterrent Claim - The addition of an oral abuse deterrent
claim into the label that indicates that Xtampza ER has
physicochemical properties that are expected to reduce abuse via
the oral route.
Fourth Quarter and 2017 Financial
Results
Net Product Revenues for Xtampza ER were $10.8
million for the quarter ended December 31, 2017 (the “2017
Quarter”) compared to $1.3 million for the quarter ended December
31, 2016 (the “2016 Quarter”). For the year ended December
31, 2017, Net Product Revenues were $28.5 million compared to $1.7
million for the year ended December 31, 2016. The quarter ended
September 30, 2017 included a one-time $4.4 million increase to Net
Product Revenue as a result of the Company’s change to the sell-in
method of recognizing revenue during the quarter.
Net loss for the 2017 Quarter was $17.4 million, or $0.54 per
share (basic and diluted), as compared to net loss of $27.6
million, or $1.02 per share (basic and diluted), for the 2016
Quarter. Net loss includes stock-based compensation expense
of $2.1 million and $1.6 million for the 2017 Quarter and 2016
Quarter, respectively.
Research and development expenses were $2.2 million for the 2017
Quarter compared to $3.3 million for the 2016 Quarter. The
decrease was primarily related to a decrease in product development
manufacturing costs of $664,000 and a decrease in research-related
regulatory costs of $584,000.
Selling, general and administrative expenses were $25.1 million
for the 2017 Quarter compared to $25.4 million for the 2016
Quarter. The decrease was primarily related to higher sales
and marketing costs of $3.4 million in the 2016 Quarter due to the
launch of Xtampza and a decrease in Post Marketing Requirements and
other regulatory costs of $1.4 million in the 2017 Quarter.
These decreases were partially offset by increased personnel
related costs of $2.8 million and a one-time impairment charge of
$1.8 million relating to the termination of the Onsolis license and
development agreement.
Collegium had cash and cash equivalents of $118.7 million as of
December 31, 2017, compared to $153.2 million as of December 31,
2016. Cash used in operating and investing activities for the
2017 Quarter was $13.5 million.
As of December 31, 2017, there were 32,770,678 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 into 2020.
Conference Call Information
Collegium will host a conference call and live audio webcast on
Wednesday, March 7, 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:
764-8078. 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.
LIMITATIONS OF USE
Because of the risks of addiction, abuse, and misuse with
opioids, even at recommended doses, and because of the greater
risks of overdose and death with extended-release opioid
formulations, reserve Xtampza ER for use in patients for whom
alternative treatment options (e.g., non-opioid analgesics or
immediate-release opioids) are ineffective, not tolerated, or would
be otherwise inadequate to provide sufficient management of
pain.
Xtampza ER is not indicated as an as-needed (prn) analgesic.
The Full Prescribing Information for Xtampza ER contains the
following Boxed Warning:
WARNING: ADDICTION, ABUSE, AND MISUSE;
LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;
NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4
INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse Xtampza ER exposes
patients and other users to the risks of opioid addiction, abuse,
and misuse, which can lead to overdose and death. Assess each
patient’s risk prior to prescribing Xtampza ER and monitor all
patients regularly for the development of these behaviors or
conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may
occur with use of Xtampza ER. Monitor for respiratory
depression, especially during initiation of Xtampza ER or following
a dose increase.
Accidental Ingestion Accidental ingestion of
even one dose of Xtampza ER, especially by children, can result in
a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome Prolonged
use of Xtampza ER during pregnancy can result in neonatal opioid
withdrawal syndrome, which may be life threatening if not
recognized and treated, and requires management according to
protocols developed by neonatology experts. If opioid use is
required for a prolonged period in a pregnant woman, advise the
patient of the risk of neonatal opioid withdrawal syndrome and
ensure that appropriate treatment will be available.
Cytochrome P450 3A4 Interaction The concomitant
use of Xtampza ER with all cytochrome P450 3A4 inhibitors may
result in an increase in oxycodone plasma concentrations, which
could increase or prolong adverse drug effects and may cause
potentially fatal respiratory depression. In addition,
discontinuation of a concomitantly used cytochrome P450 3A4 inducer
may result in an increase in oxycodone plasma concentration.
Monitor patients receiving Xtampza ER and any CYP3A4 inhibitor or
inducer.
Risks From Concomitant Use With Benzodiazepines Or Other
CNS Depressants
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS) depressants, including alcohol, may result in
profound sedation, respiratory depression, coma, and death.
• Reserve concomitant prescribing of Xtampza ER and
benzodiazepines or other CNS depressants for use in patients for
whom alternative treatment options are inadequate.
• Limit dosages and durations to the minimum
required.
• Follow patients for signs and symptoms of
respiratory depression and sedation.
IMPORTANT SAFETY INFORMATION
Xtampza ER is contraindicated in patients with: significant
respiratory depression; acute or severe bronchial asthma in an
unmonitored setting or in the absence of resuscitative equipment;
known or suspected gastrointestinal obstruction, including
paralytic ileus; and hypersensitivity (e.g., anaphylaxis) to
oxycodone.
Xtampza ER contains oxycodone, a Schedule II controlled
substance. As an opioid, Xtampza ER exposes users to the risks of
addiction, abuse, and misuse. As extended-release products, such as
Xtampza ER, deliver the opioid over an extended period of time,
there is a greater risk for overdose and death due to the larger
amount of oxycodone present.
Potential serious adverse events caused by opioids include
addiction, abuse, and misuse, life-threatening respiratory
depression, neonatal opioid withdrawal syndrome, risks of
concomitant use or discontinuation of cytochrome P450 3A4
inhibitors and inducers, risks from concomitant use with
benzodiazepines or other CNS depressants, risk of life-threatening
respiratory depression in patients with chronic pulmonary disease
or in elderly, cachectic, or debilitated patients, adrenal
insufficiency, severe hypotension, risks of use in patients with
increased intracranial pressure, brain tumors, head injury, or
impaired consciousness, risks of use in patients with
gastrointestinal conditions, risk of use in patients with seizure
disorders, withdrawal, risks of driving and operating machinery,
and laboratory monitoring.
The most common AEs (>5%) reported by patients in the Phase 3
clinical trial during the titration phase were: nausea
(16.6%), headache (13.9%), constipation (13.0%), somnolence (8.8%),
pruritus (7.4%), vomiting (6.4%), and dizziness (5.7%).
For Important Safety Information including full prescribing
information visit: http://www.xtampzaer.com/
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 ability 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 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 regulation in the manufacture 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 are described
under the heading "Risk Factors" in our Annual Report on Form 10-K
for the year ended December 31, 2016, 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) |
|
|
December 31, |
|
December 31, |
|
2017 |
|
2016 |
Cash and cash
equivalents |
$118,697 |
|
$153,225 |
Accounts
receivable |
|
9,969 |
|
|
2,129 |
Inventory |
|
1,813 |
|
|
1,316 |
Prepaid expenses and
other current assets |
|
3,005 |
|
|
1,905 |
Property and equipment,
net |
|
1,826 |
|
|
1,038 |
Intangible assets,
net |
|
— |
|
|
2,103 |
Restricted cash |
|
97 |
|
|
97 |
Other long-term
assets |
|
161 |
|
|
204 |
Total
assets |
$135,568 |
|
$162,017 |
|
|
|
|
Accounts payable and
accrued expenses |
$14,225 |
|
$17,985 |
Accrued rebates,
returns and discounts |
|
15,784 |
|
|
— |
Deferred revenue |
|
— |
|
|
4,944 |
Other liabilities |
|
1,479 |
|
|
4,180 |
Stockholders’
equity |
|
104,080 |
|
|
134,908 |
Total
liabilities and stockholders’ equity |
$135,568 |
|
$162,017 |
|
|
|
|
|
|
Collegium Pharmaceutical, Inc. |
|
Unaudited Condensed Statements of
Operations(in thousands, except share and per share
amounts) |
|
|
|
|
|
Three months ended December 31, |
|
Year ended December 31, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
Product revenues,
net |
$10,794 |
|
|
$1,303 |
|
|
$28,476 |
|
|
$1,711 |
|
|
|
|
|
|
|
|
|
Costs and
expenses: |
|
|
|
|
|
|
|
Cost of product
revenues |
|
1,094 |
|
|
|
184 |
|
|
|
2,595 |
|
|
|
213 |
|
Research and
development |
|
2,194 |
|
|
|
3,331 |
|
|
|
8,572 |
|
|
|
14,948 |
|
Selling, general
and administrative |
|
25,089 |
|
|
|
25,367 |
|
|
|
92,756 |
|
|
|
80,632 |
|
Total costs and
expenses |
|
28,377 |
|
|
|
28,882 |
|
|
|
103,923 |
|
|
|
95,793 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(17,583 |
) |
|
|
(27,579 |
) |
|
|
(75,447 |
) |
|
|
(94,082 |
) |
Interest income
(expense), net |
|
180 |
|
|
|
20 |
|
|
|
582 |
|
|
|
(94 |
) |
Net
loss |
($17,403 |
) |
|
($27,559 |
) |
|
($74,865 |
) |
|
($94,176 |
) |
|
|
|
|
|
|
|
|
Loss per share–basic
and diluted |
($0.54 |
) |
|
($1.02 |
) |
|
($2.47 |
) |
|
($3.88 |
) |
Weighted-average shares
-basic and diluted |
|
32,485,572 |
|
|
|
27,100,231 |
|
|
|
30,265,262 |
|
|
|
24,262,945 |
|
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