AMPH 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• In June 2026, we achieved the first annual net sales milestone for BAQSIMI®, with sales of $175.0 million for the contract year, under the asset purchase agreement, or the Purchase Agreement, with Eli Lilly & Company, or Lilly. That milestone triggered a payment of $100.0 million which is due in the…

• allocated to the acquired intangible assets and property, plant and equipment in our condensed consolidated balance sheet as of June 30, 2026. For more information regarding BAQSIMI®, see “Part I – Item 1. Financial Statements (unaudited) – Notes to Condensed Consolidated Financial Statements – Note…

• In July 2026, our subsidiary International Medication Systems, Limited, or IMS, received a warning letter, or the Warning Letter, from the FDA relating to IMS's drug manufacturing facility located in South El Monte, California. The Warning Letter cites violations of current Good Manufacturing Practi…

• We take the matters identified in the Warning Letter seriously. Since the conclusion of the FDA inspection, IMS has implemented and is continuing to implement corrective actions in response to the Form 483 and Warning Letter. We have timely responded to the FDA regarding IMS’s remediation plan. We c…

• In April 2026, we launched our ipratropium bromide HFA inhalation aerosol, which was approved by the FDA in February 2026.

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• In January 2026, we entered into a License Agreement with Nanjing Hanxin Pharmaceutical Technology Co., Ltd., or Hanxin, pursuant to which Hanxin has granted an exclusive license to a fully synthetic corticotropin (ACTH) analog, now designated AMP-110, in the United States and Canada. AMP-110 is des…

• For more information regarding the Hanxin license agreement, see “Part I – Item 1. Financial Statements (unaudited) – Notes to Condensed Consolidated Financial Statements – Note 17. Commitments and Contingencies.”

• The decrease in sales of BAQSIMI® was primarily due to a lower average selling price, as a result of a change in gross-to-net discounts due to changes in chargebacks and rebates and changes to the customer mix, impacting sales of approximately $8.0 million. This decrease was partially offset by an i…

• We anticipate that sales of glucagon will continue to decline in the future due to competitive dynamics. We also anticipate that sales of epinephrine and other products will continue to fluctuate depending on the ability of our competitors to supply market demands.

• A significant portion of our customer shipments in any period relate to orders received and shipped in the same period, generally resulting in low product backlog relative to total shipments at any time. We had no significant backlog as of March 31, 2026. Historically, our backlog has not been a mea…

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• All facilities of Amphastar, our subsidiaries and our CMOs and suppliers are periodically subject to inspection by the FDA and other governmental entities, and operations at these facilities could be interrupted or halted if the FDA or another governmental entity deems such inspections as unsatisfac…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• All facilities of Amphastar, our subsidiaries and our CMOs and suppliers are periodically subject to inspection by the FDA and other governmental entities, and operations at these facilities could be interrupted or halted if the FDA or another governmental entity deems such inspections as unsatisfac…

• loans accrues at market rates. UBS has an unlimited and unilateral right to call each of the credit lines for any reason whatsoever, and each of East West and Cathay Bank has acceleration rights to protect itself in the event of a default.

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• On March 10, 2026, William J. Peters, our Chief Financial Officer, Executive Vice President of Finance, and Treasurer,

• President of International Medication Systems, Limited, and Director, adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of an aggregate of up to 115,281 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(…

• No other officers or directors, as defined in Rule 16a-1(f), adopted or terminated a Rule 10b5-1 trading arrangement, or a non-Rule 10b5-1 trading arrangement, each as defined in Regulation S-K Item 408.