COLL 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• Azstarys is a CNS stimulant prescription medicine that contains serdexmethylphenidate and dexmethylphenidate approved by the FDA in March 2021 for the treatment of ADHD in people six years of age and older. We began recognizing product revenue related to Azstarys in May 2026 following our acquisitio…

• Changes in our critical accounting policies with respect to our Annual Report include business combination accounting and valuation of acquired assets, including goodwill and intangible assets, as described below.

• Business Combination Accounting and Valuation of Acquired Net Assets

• We completed the Azstarys Acquisition on May 12, 2026, which was accounted for as a business combination. To determine whether the acquisition should be accounted for as a business combination or as an asset acquisition, we made certain judgments regarding whether the acquired set of activities and …

• The acquisition method of accounting requires that we recognize the assets acquired and liabilities assumed at their acquisition date fair values. Goodwill is measured as the excess of consideration transferred over the acquisition date net fair values of the assets acquired and the liabilities assu…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• 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…

• Cost of product revenues (excluding intangible asset amortization)20,801 24,960

• Gain on fair value remeasurement of contingent consideration— (786)

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

• Product revenues, net were $193.5 million for the three months ended March 31, 2026 (the “2026 Quarter”), compared to $177.8 million for the three months ended March 31, 2025 (the “2025 Quarter”). The $15.7 million increase is primarily due to increased revenue for Jornay PM of $10.4 million, Xtampz…

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• We are currently in the process of evaluating and integrating the acquired operations, processes, and internal controls related to the acquisition of Azstarys. Except for the acquisition of Azstarys, which we expect to integrate into our existing internal control environment, there has been no chang…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the fiscal quarter covered by this Quarterly Report that have materially affected, or are reasonably likely to materially affect, our internal control…

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• •Our ability to realize the benefits of the acquisition of Azstarys is substantially dependent on the timely and effective integration of Azstarys;

• pharmaceutical products. This heightened enforcement environment increases the risk that our promotional materials, even if we believe them to be compliant, could be challenged by the FDA or by consumers or plaintiffs’ counsel. If we cannot successfully manage the promotion of our products, we could…

• In particular, Xtampza ER has FDA-approved product labeling that describes its abuse deterrent features, which allows us to promote those features and differentiate Xtampza ER from other opioid products containing the same active pharmaceutical ingredients. Because the FDA closely regulates promotio…

• We have sought in the past, and may seek in the future, FDA pediatric exclusivity for some of our products. Pediatric exclusivity, if granted, adds six months of patent term and marketing exclusivity to existing exclusivity periods for all formulations, dosage forms, and indications for the active m…

• We currently rely on a sole supplier or limited number of suppliers to manufacture the active pharmaceutical ingredients of our products. We contract with these suppliers for commercial supply to manufacture our products. Further, our suppliers of the active pharmaceutical ingredients for Xtampza ER…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• •The announcement and pendency of our acquisition of AZSTARYS® may have an adverse effect on our business, financial condition, operating results and cash flows;

• •Our ability to realize the benefits of the acquisition of AZSTARYS® is substantially dependent on the timely and effective integration of AZSTARYS®;

• under the 2025 Credit Agreement. In addition, because our assets are pledged as a security under the 2025 Credit Agreement, if we are not able to cure any default or repay outstanding borrowings, our assets would be subject to the risk of foreclosure by our lenders.

• In particular, Xtampza ER has FDA-approved product labeling that describes its abuse deterrent features, which allows us to promote those features and differentiate Xtampza ER from other opioid products containing the same active pharmaceutical ingredients. Because the FDA closely regulates promotio…

• even though the FDA-approved product labeling includes a description of the abuse deterrent characteristics of Xtampza ER, the FDA may object to our marketing claims and product advertising campaigns.