Collegium Reports Second Quarter Financial Results and Provides Corporate Update
FDAapproval for Xtampza® ER, Company’s lead opioid analgesic with abuse-deterrent properties
- Announced U.S. commercial launch of Xtampza ER
- Reported positive results from a clinical study comparing effect of physical manipulation of Xtampza ER with the abuse-deterrent version of OxyContin®
- Reported positive results from a clinical study evaluating Hydrocodone DETERx® as a second product candidate
- Licensed U.S. rights to commercialize ONSOLIS® (fentanyl buccal soluble film) from
BioDelivery Sciences International
“The second quarter of 2016 marked an important milestone for Collegium as we transitioned from a development stage company to a commercial pharmaceutical company. Following the
April 2016, the FDAapproved Xtampza ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication 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.
June 2016, Collegium announced the commercial launch of Xtampza ER. The Xtampza ER commercial launch is supported by a field sales force of approximately 120 retail sales professionals with a primary focus on pain specialists. In addition, an institutional focused sales force of specialty sales representatives is targeting hospitals and long term care facilities.
May 2016, Collegium announced positive topline results from a comparative clinical trial evaluating the effect of physical manipulation by crushing of Xtampza ER compared with the abuse-deterrent version of OxyContin® (oxycodone hydrochloride extended-release tablets).
June 2016, Collegium announced positive topline results from a clinical study evaluating Hydrocodone DETERx as a second product candidate using its proprietary DETERx drug delivery technology platform.
May 2016, Collegium announced the licensing of the U.S. rights to develop and commercialize ONSOLIS (fentanyl buccal soluble film) from BioDelivery Sciences International, Inc.
Second Quarter 2016 Financial Results
Net loss for the quarter ended
Research and development expenses were
Selling, general and administrative expenses were
There were 23,528,119 common shares outstanding as of
Based on our current operating plans, we expect that our existing cash resources will fund our operations into early 2018.
Conference Call Information
Collegium will host a conference call and live audio webcast on
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 visit 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 commercialize our products and product candidates; the existence of any patent infringement or similar litigation relating to any of our products or product candidates, and costs and delays associated with such litigation; the size and growth potential of the markets for our product and product candidates, and our ability to service those markets; our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of our product and product candidates; the success, cost and timing of our product development activities, studies and clinical trials; the success of competing products that are or become available; and our expectations regarding our ability to obtain and adequately maintain sufficient intellectual property protection for our product candidates. These and other risks are described under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended
|Collegium Pharmaceutical, Inc.
Unaudited Selected Consolidated Balance Sheet Information
|June 30,||December 31,|
|Cash and cash equivalents||$||110,747||$||95,697|
|Accounts receivable, net||2,952||-|
|Prepaid expenses and other current assets||1,537||1,186|
|Property and equipment, net||676||738|
|Intangible assets, net||2,500||-|
|Accounts payable and accrued expenses||$||11,610||$||5,765|
|Total liabilities and stockholders’ equity||$||119,723||$||97,718|
|Collegium Pharmaceutical, Inc.
Unaudited Condensed Statements of Operations
(in thousands, except share and per share amounts)
|Three months ended June 30,||Six months ended June 30,|
|Research and development||$||4,301||$||1,641||$||8,363||$||3,086|
|Selling, general and administrative||20,173||2,934||31,698||5,120|
|Total operating expenses||24,474||4,575||40,061||8,206|
|Loss from operations||(24,474||)||(4,575||)||(40,061||)||(8,206||)|
|Other expense, net||(46||)||(99||)||(111||)||(163||)|
|Loss per share–basic and diluted||$||(1.05||)||$||(0.45||)||$||(1.73||)||$||(0.18||)|
|Weighted-average shares -basic and diluted||23,417,378||11,791,546||23,273,765||6,426,431|
Douglas CarlsonVice President, Corporate Development firstname.lastname@example.org