Collegium Reports Fourth Quarter Financial Results and Provides Corporate Update
- Xtampza ER prescriptions grew by 37% in the fourth quarter
- FDA Approval of sNDA, including Comparative OxyContin Data in label
- Expanded product portfolio by licensing rights to commercialize Nucynta franchise
- Revenue growth and strong balance sheet provide cash runway into 2020
- Conference call scheduled for today at
4:30 p.m. ET
“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
“In 2017, our focus on operational execution generated significant momentum with Xtampza ER,” said
- 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 Advantageand 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.
- 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.
- 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
Net loss for the 2017 Quarter was
Research and development expenses were
Selling, general and administrative expenses were
Collegium had cash and cash equivalents of
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
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
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 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/
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
|Collegium Pharmaceutical, Inc.|
|Unaudited Selected Consolidated Balance Sheet Information
|December 31,||December 31,|
|Cash and cash equivalents||$118,697||$153,225|
|Prepaid expenses and other current assets||3,005||1,905|
|Property and equipment, net||1,826||1,038|
|Intangible assets, net||—||2,103|
|Other long-term assets||161||204|
|Accounts payable and accrued expenses||$14,225||$17,985|
|Accrued rebates, returns and discounts||15,784||—|
|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,|
|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||)|
|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|
Source: Collegium Pharmaceutical, Inc.