Collegium Reports Third Quarter Financial Results and Provides Corporate Update
- Broadened Xtampza ER market access with commitments from large commercial payers
- Submitted Supplemental New Drug Application to the
- Submitted New Drug Submission to
“It has been a very productive quarter for Collegium. We have made significant progress on the commercial launch of Xtampza® ER with broadened payer coverage, pharmacy availability, customer contracting, as well as increasing the physician prescriber base of the product,” stated
UnitedHealthand Cignaannounced availability for Xtampza ER for 15.6 million and 6.4 million contracted lives, respectively. Effective January 1, 2017, the UnitedHealthcontract makes Xtampza ER a preferred product and the exclusive extended-release oxycodone product on its formulary with the removal of OxyContin from formulary.
September 2016, Collegium announced the launch of OpioidIQ, an online educational tool to assist physicians and other healthcare providers with more effective pain management (available at www.OpioidIQ.com). The goal of OpioidIQ is to connect healthcare providers to information and resources aimed at supporting the safe and effective management of their patients with chronic pain who are appropriate for treatment with an opioid analgesic.
October 2016, Collegium launched promotional material and marketing programs through its commercial organization after receiving feedback from the Office of Prescription Drug Promotion (OPDP) of the FDA.
October 2016, Collegium announced the submission of a Supplemental New Drug Application (sNDA) to the FDAto enhance the label for Xtampza ER. The sNDA includes comparative oral pharmacokinetic data from two clinical studies evaluating the effect of physical manipulation by crushing Xtampza ER compared to crushing the abuse-deterrent version of OxyContin.
October 2016, Collegium announced the submission of a New Drug Submission (NDS) to Health Canadaseeking marketing approval of Xtampza ER. The NDS submission marks the first regulatory submission seeking to expand the geographic footprint of Xtampza ER in an important market outside of the U.S.
- During the quarter, Collegium announced three scientific publications on Xtampza ER in
The Journal of Clinical Pharmacology, The Journal of the American Medical Association (JAMA) and Current Medical Researchand Opinion.
October 2016, Collegium announced a public offering of 5,000,000 shares of its common stock at a price of $16.00per share. The gross proceeds of this offering were $80 million, excluding underwriters’ discounts and commissions and offering expenses payable by the Company.
Third Quarter 2016 Financial Results
Net loss for the quarter ended
Net product revenues for Xtampza ER were
Research and development expenses were
Selling, general and administrative expenses were
Based on our current operating plans, we believe that our existing cash resources, together with expected cash inflows from the commercialization of Xtampza as well as the proceeds of our follow-on offering completed in
Conference Call Information
Collegium will host a conference call and live audio webcast on
http://www.collegiumpharma.com/. An archived webcast will be available on the Company’s website approximately two hours after the event.
Collegium is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its proprietary DETERx® technology platform for the treatment of chronic pain and other diseases. The DETERx technology platform is designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options.
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
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.
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 due to interactions with central nervous system 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 press release 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; 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 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 against us, including litigation with
|Collegium Pharmaceutical, Inc.|
|Unaudited Selected Consolidated Balance Sheet Information|
|September 30,||December 31,|
|Cash and cash equivalents||$||91,028||$||95,697|
|Accounts receivable, net||1,679||-|
|Prepaid expenses and other current assets||1,086||1,186|
|Property and equipment, net||772||738|
|Intangible assets, net||2,273||-|
|Other long-term assets||214||-|
|Accounts payable and accrued expenses||$||15,607||$||5,765|
|Total liabilities and stockholders’ equity||$||98,725||$||97,718|
|Collegium Pharmaceutical, Inc.|
|Unaudited Condensed Statements of Operations|
|(in thousands, except share and per share amounts)|
|Three months ended September 30,||Nine months ended September 30,|
|Product revenues, net||$||408||$||—||$||408||$||—|
|Costs and expenses:|
|Cost of product revenues||29||—||29||—|
|Research and development||3,254||3,358||11,617||6,444|
|Selling, general and administrative||23,567||5,907||55,266||11,027|
|Total costs and expenses||26,850||9,265||66,912||17,471|
|Loss from operations||(26,442||)||(9,265||)||(66,504||)||(17,471||)|
|Other expense, net||(2||)||(97||)||(113||)||(259||)|
|Loss per share–basic and diluted||$||(1.13||)||$||(0.46||)||$||(2.85||)||$||(0.94||)|
|Weighted-average shares -basic and
Douglas CarlsonVice President, Corporate Development firstname.lastname@example.org