COLL 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• We have entered into an authorized generic agreement with Hikma Pharmaceuticals USA Inc. (“Hikma”), pursuant to which we granted Hikma rights relating to an authorized generic version of the Nucynta Products in the United States. Hikma launched a generic version of Nucynta IR on February 25, 2026 an…

• Symproic, an oral formulation of naldemedine, was approved by the FDA in March 2017 for the treatment of opioid-induced constipation (“OIC”) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g.…

• On March 19, 2026, the Company entered into an Equity Purchase Agreement (the “Azstarys Purchase Agreement”) with Corium Therapeutics Holdings, LLC and Corium, LLC. Pursuant to the terms of the Azstarys Purchase Agreement, the Company will acquire AZSTARYS®, a central nervous system stimulant prescr…

• Comparison of the three months ended March 31, 2026 and March 31, 2025

• The increase in revenue for Jornay PM of $10.4 million is primarily due to higher sales volume, lower gross-to-net adjustments related to provisions for co-pay program incentives, and higher gross price, partially offset by higher gross-to-net adjustments related to provisions for rebates and produc…

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• Symproic was approved by the FDA in March 2017 for the treatment of opioid-induced constipation (“OIC”) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. W…

• Comparison of the three months ended September 30, 2025 and September 30, 2024

• The increase in revenue for Jornay PM of $33.8 million is due to the acquisition of the product from the Ironshore Acquisition in September 2024.

• The increase in revenue for the Nucynta Products of $9.7 million is primarily due to lower gross-to-net adjustments related to provisions for rebates, including the recognition of $2.8 million related to certain rebate settlements during the 2025 Quarter. In addition, revenue increased due to lower …

• The increase in revenue for Xtampza ER of $1.0 million is primarily due to lower gross-to-net adjustments related to provisions for rebates and higher gross price, partially offset by lower sales volume.

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• The 2025 Term Loan bears interest at an annual rate equal to Secured Overnight Financing Rate (“SOFR”) plus a spread adjustment ranging from 2.75% to 3.75%. The 2025 Term Loan is subject to quarterly amortization payments of the originally funded amount equal to 1.25% in each quarter of 2026, 1.875%…

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• The 2024 Term Loan bears interest at a rate equal to adjusted term SOFR + 4.50%, and is subject to quarterly amortization payments equal to 2.50% of the original funded amount of the 2024 Term Loan. Based on the outstanding principal amount of the 2024 Term Loan as of September 30, 2025 of $581.3 mi…

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• •Social issues around the abuse of opioids, including law enforcement concerns over diversion of opioids and regulatory and enforcement efforts to combat abuse, could decrease the potential market for our opioid products and may adversely impact external investor perceptions of our business;

• •If the FDA or other applicable regulatory authorities approve generic products with claims that compete with our opioid products, our sales could decline;

• •If the third-party manufacturers of our products fail to devote sufficient time and resources to these products, or their performance is substandard, and/or we encounter challenges with our dedicated manufacturing suite at our third-party manufacturer’s site for the manufacturing of Xtampza ER, our…

• •Because we currently rely on a sole supplier or limited number of suppliers to manufacture the active pharmaceutical ingredient of our products, any production problems with any of these suppliers could have a material adverse effect on us;

• •We depend on wholesale pharmaceutical distributors for retail distribution of our products; if we lose any of our significant wholesale pharmaceutical distributors or their distribution network is disrupted, our financial condition and results of operations may be adversely affected;

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• rebates that manufacturers offer to pharmaceutical benefit managers, or the discounts that manufacturers provide others within the pharmaceutical distribution chain;

• ●Social issues around the abuse of opioids, including law enforcement concerns over diversion of opioids and regulatory and enforcement efforts to combat abuse, could decrease the potential market for our opioid products and may adversely impact external investor perceptions of our business;

• ●If the FDA or other applicable regulatory authorities approve generic products with abuse deterrent claims that compete with our opioid products, our sales could decline;

• ●If the third-party manufacturers of our products fail to devote sufficient time and resources to these products, or their performance is substandard, and/or we encounter challenges with our dedicated manufacturing suite at our third-party manufacturer’s site for the manufacturing of Xtampza ER, our…

• ●Because we currently rely on a sole supplier or limited number of suppliers to manufacture the active pharmaceutical ingredient of our products, any production problems with any of these suppliers could have a material adverse effect on us;

相对上期新增的文字 · 来源:10-Q · 2026-05-07

• During the three months ended March 31, 2026, none of our directors or officers adopted, amended, or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

相对上期删除的文字 · 来源:10-Q · 2025-11-06

• The following table shows the “Rule 10b5-1 trading arrangements” or “non-Rule 10b5-1 trading arrangements” (as each term is defined in Item 408(a) of Regulation S-K) adopted, amended, or terminated by our directors and officers during the three months ended September 30, 2025:

• (1)A trading arrangement may expire on an earlier date if all contemplated transactions are completed before such trading arrangement’s expiration date, upon termination by broker or the holder of the trading arrangement, or as otherwise provided in the trading arrangement.