Amphastar Pharmaceuticals Inc

ITEM 1A. RISK FACTORS

Except as noted below, there were no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 20245, filed with the SEC on March 3February 26, 2025.

Because a portion of our 6.

We must manufacturing takes place in China, a significant disruption in the constre our drug production or operation of os at our manufacturing faciility in China, political unresties in China, tariffs, impacts of outbreaks of health epidemics, or changes in social, political, trade, health, economic, environmental, or climate-related conditions or in laws, reconformity with cGMP regulations and policies governing foreign trade could materially and adversely affect our business, financial condition and results of operations.

We currently manufacture the starting material for Amphadase and enoxaparin as well as the APIs for isoproterenol, nitroprusside, and medroxyprogesterone at our manufacturing facility in China, and we plan to use this facility to manufacture several of the APIs f; failure to maintain compliance with cGMP regulations may prevent or products in our pipeline. Additionally, we intend to continue to invest in tdelay the expansion of this manufacturing facility. Our manufacturing facility and operations in China involve significant risks, including:

Any of these e or matters could materially and adversely affect our business and results rketing of operations. These interruptions or failures could impair our ability to operate our business, impede the commercialization of our ur products or product candidates or delay the introduction of new products, impact our product quality, or impair our competitive position. Any material adverse effect on our employees, suppliers, and logistics providers could have a material adverse effect on our manufacturand may prevent us from gaining operations in China or the supply of raw materials or APIs originating from China.

Enhanced trade tariffs, import restrictions, export restrictions, Chinese regulations or other trade barriers may materially harm our business.

We are continuing to expand our international operations as part of our growth strategy. There is currently significant uncertainty about the future relationship between the United States and various other countries, most signifiapproval of our products.

All of our products and product cantly China, with respect to trade policies, treaties, government regulations and tariffs. There is a possibility that the United States could continue to impose greater restrictions on international trade and significant increases in tariffs on goods imported into the United States. For example, since September 2018, the U.S. Trade Representative (the USTR) enacted Section 301 tariffs on certain commodities from certain U.S. trading partners, most prominently China and Brazil, affecting hundreds of billions of dollars of imports. In addition, since February 4, 2025, the U.S. government has imposedidates for use in clinical studies must be manufactured, packaged, labeled an additional fentanyl-related tariffs of 10% to 35% on the import of almost all Chinese-, Mexican-, and Canadian-origin itemsd stored in accordance with an exception fcGMP. For items qualifying for duty-free treatment under the U.S.-Mexico-Canada Agreement, as well as additional reciour approved procal tariffs of 10% to 125% on certain products of most other U.S. trading partners, including China since April 2025, with exempt, modifications for certain pharmaceuticals, semiconductor, enhancements, and consumer electronics. Since March 2025, the U.S. government has also implemented new Section 232 tariffs of 10% to 50% on various commodities based on findings by the U.S. government that imports of these or changes in manufacturing processes and sitems threaten to impair U.S. national security, including with regard to imports of certain articles of steel and aluminum; passenger vehicles, trucks, and automotive components; certain articles of copper; and timber, lumber, and certain article of wood. These trade policies, including applicable items, tariff rates, countries, and exceptions, are ss may require supplemental FDA approval, which may be subject to change. Additional tariffs may in the future also be implemented by the U.S. government (including a lengthy application imports of pharmaceutical products into the United States currently under Section 232 investigation by the U.S. Department of Commerce, among other potential tariffs), the implementation, scope, and duration of which remprocess or which we may be unable to obtain uncertain. Tariffs on imports of APIs and starting materials used in our products, or retaliatory trade measures taken by China or other countries, which could potentially include restricted access to APIs or starting materials used in our products, could result in us needing to raise prices, make changes to our products, or materially harm o.

All facilities of Amphastar, our subsidiaries and our business, financial condition and results of operations. Further, the continued threats of tariffs, trade restrictions, and trade barriers could have a generaCMOs and suppliers are periodically disruptive impact on the global economy and, therefore, negatively impact our sales. Given the focus of the U.S. government on issues related to China, including the imposition of additional restrisubject to inspections on exports related to semi-conductor manufacturing and supercomputing, the imposition of outbound investment controls affecting U.S. persons abilit by to invest in certain enterprises in China, and the addition of entities based in China to various restricted party lists, along with uncertainty regarding how the U.S. or foreign gohe FDA and other governments will act with respect to tariffs, international trade agreements and policial entities, a trade war, further governmental action related to tariffs or internnd operational trade policies, or additional tax or other regulatory changes in ths at these future could occur and could directly and adversely impact our financial results and results of operations.

Our business anacilities could be interrupted operationsr have been impaclted in the past, and may be impacted in the future, in f the event of system breach or failure.

We and our third-party service providers and other third parties with whom we do business, including our collaborators, third-parFDA or another governmental entity providers, distributors, customers and other contractors utilize informadeems such inspection technology systems and networks to transmit, store and otherwise process electronic data in connection with our business activities, including our supply chain processes, operations and communications including, in some casess as unsatisfactory. For example, our clinical data and business proprietary

ifacilities information, and electronic data interchange, on purchase orders, invoices, chargebacks, among other things. We and such third parties, including and our collaborators, third-party service providers, distributors and other contractors, also collect, transmit, store and otherwise process certain data relating to individuals, including about our personnel, business partners, and others, which may b Rancho Cucamonga, CA, South El Monte, CA, Canton, MA, ragny Sur Epte, France, and Nanjing, China are subject to applicable data protection, security and privacy laws and regulatiFDA cGMP inspections that require adoption of minimum information security standards. The cost of compliance with applicable dataas well as protection, security and privacy laws and regulations have increased ae-approval, routine and may increase in othe future.

Despite our implementation of security measures to protr inspect the confidentiality, integrity, and availability of ions by the systems, networks and data within our control from various threats (e.g., threats of cyber-attacks, system breaches, aFDA, state, and other security breaches and incidents, malware, viruses, hacking, fraudulent use, social engineering attacks, phishing attacks, ransomware attacks, credential-stuffing attacks, denial-of-service attacks, unauthorized access, insider threats, accidental disclosures, intellectual property theft and economic espionage, exploitregulatory authorities and may be again in the future per applicable vulnerabilities, defects or bugs in our or our third-party service providers systems, natural disasters, war, terrorism, telecommunications and electrical outages, breakdowns, damage, outages, interruptions, and other cyber-events), we and certain of our third-party service providers have experienclaw. Our facility in South El Monte, CA was inspected and may continue to experience cyber-attacks, outages, interruptions, and other cyby the FDA in December-events of varying degrees from time to time. For example, in the first quarter of  2022, our Chinese subsidiary, ANP, was subject to a security incident that resulted in a temporary disruption to some of its internal computer systems. We worked with ANP to improve and implement additional security measures to its systems and networks. We incurred minimal costs to respond to the ANP incident. In addition, in the second q5, and we responded to the Form 483 observations in Januarter of y 2020, we were subject to a security incid6. Subsequent that resultedly, in a temporary disruption to some of our internal computer systems. In response to this incident, we engaged aApril 2026, the FDA notified us third-party forensic expert to investigate, and determined that cyber criminals illegally obtained certain personal information of certain current and former employees. We notat the facility would be classified affected individuals and regulators, as we deemed was required or appropriate. We incurred minims Official cost to respond to this incident. Our systems and networks and the systems and networks of our third-party service providers, have been, and in the future may be, breached or disrupted due to the threats described aboAction Indicated. We have or otherwise. The size and complexity of our systems may make them potentially vulnerable to breakdown or interruption, whether due to computer viruses or other causes, which may result in loss of data or the impairment of production and other supply chain procundertaken corrective actions to addresses, adversely affecting our business.

Techniques used to sabotage or obtain unauthorized access to systems and networks are constantly evolving and, in some instances, are  the observations not identified until or after they are launched against a target. We aed in the Form FDA 483 and our third-party service providers may be unable todo not anticipate these techniques, discover threats and react in a timely manner, or implement adequate preventative or mitigating measures. Further, system breaches, malware, ransomware, computer hacking, and insider threats haany interruption that could have become more prevalent. For example, companies have experienced an increaa material adverse in phishing and social engineering attacks from third parties in connection with the increase in employees working remotely in recent years. We effect on Amphastar and our third-party service providers who may be oits operating with personnel in remote work environments may have increased security risks, due to increased use of home Wi-Fi networks and virtual private networks, as well as increased disbursementons.

Compliance with cGMP standards requires substantial expenditures of physical machines. Also, due to political uncertainttime, money and military actionseffort in such as Russireas invasion of Ukraine or conflicts in the Middle East, we aas production and our third-parquality service providers are vulnerablecontrol to heightened risks of cyber threats and cyber-attacks from or affiliated with nation-state actors, including attacks thatensure full technical could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our products and services. While we implement security measures designed to reduce these risks, mpliance. Failure to comply with cGMP or with othere is no guarantee that these measures will be adequate to safeguard all systems and networks. Any failure of ourselves or our third-party service providers to maintain performance, reliability, security and availability of our systems and networks, or other systems or networks on which our data is stored or processed,  state, federal, or foreign requirements may result in accidental or unlawful destruction, damage, loss, unavailability, alteration, impairment, misuse, unauthorized disclosure of, or unauthorized access to our data, including personal information.

In addition, potential legal, regulatory, contractual, financial, operational, and reputational harm may arise from the accidentunanticipated compliance expenditures, total or partial or unlawful destruction, damage, loss, unavailability, alteration, impairment, misuse, unauthorized disclosuresuspension of, or unauthorized access to our systems, networks, production or data, including data which is transmitted, stored or otherwise processed by us or by third parties, including collaborators, third-party service providers, distributors, and other contractors istribution, suspension our behalf. For example:

Inf review an effort to ensure of appropriate oversight of cyber security issues and risks, management updates the Board of Directors on cyber security matters on a quarterly basis, and the Board of Directors has assigned oversight of cyber security to the Audit Committee. Additionally, the Company has a security training and compliance program, which employees with access to informlications submitted for approval of our product candidates, termination technology, must complete annually or more often, if deemed necessary or appropriate.

There can be no assurance that we will be successful in preventing security incidents nor that we will be successful in mitigating their effects, despite the implementation of security measures for systems, networks and data within our control. Similarly, there can be no assurance that of ongoing research, disqualification of data derived from studies on our collaborators, third-party service providers, distributorproducts and other contractors will be successful in protecting our data on their systems or in prote/or enforcement acting other systems upon whions such we may rely. Furthermore, breach notification laws are not consistent among jurisdictions, and compliance and other measas recall or seizures in the event  of a security incident could resultproducts, in a substantial cost and diversion of resources and distract management and technicajunctions, civil personnel in efforts to investigate or correct the security incident, address analties and elcriminate vulnerabilities and prevent future l prosecurity incidents, and remediate ttions of the security incident, which repairing systemscompany and responding to claims of damages for actual or asserted contract breaches. Any such security incident could have a material adverse effect on our business and prospects.

Although we maintain cyber insurance coverage that may cover certain of our losses in connection with a security incident, we company officials. There cannot be certain our insurance coverage will be adequate for losses actually incurred,no assurance that insurancwe will continue to be available to us on commercially reasonable terms (if at all) or that any insurer will not deny coverage as to aremedy any future claim. The successful assertion of one or more large claims against us that exceed available insurance coverage, deficiencies cited by FDA or othe occurrence of changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements, or denials of coverage, could have a material adverse effect on our business, including our financial condition, results of operar regulatory agencies in their inspections and reputation.

Jack Y. Zhang and Mary Z. Luo have each pledged shares of our common stock to secure funds borrowed under existing credit lines from three financial institutions. Each of the lenders has varying rights as a lender, including one which has the right to conduct a forced sale at its sole discretion. An action by one of the lenders could include a sale of certain shares of our common stock pledged as collateral, the sale of which could cause the price of our common stock to decline. An action to cure and cover indebtedness by any one of the lenders could also have other negative impacts on our business.

Jack Y. Zhang and Mary Z. Luo have each pledged shares of our common stock to secure funds borrowed under existing credit lines by UBS Group and its affiliates, or UBS, East West Bank, or East West, and Cathay Bank. As of September 30March 31, 20256, UBS had extended combined credit lines of $15.0 million to Applied Physics Chemistry Laboratories, Inc., or APCL, which is controlled by Dr. Zhang and Dr. Luo, East West had agreed to a loan of up to $12.0 million to Drs. Zhang and Luo, and Cathay Bank had agreed to a loan of up to $30.0 million to APCL and Dr. Luo. The UBS credit lines are secured by a pledge of 801,1561,500,000 shares of our common stock currently held by APCL, the East West loan is secured by a pledge of 81,200,000 shares of our common stock held by APCL and Dr. Zhang, and the Cathay Bank loan is secured by a pledge of 23,000,000 shares of our common stock held by APCL and Dr. Luo. Interest on each of these

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.

We have a pledging policy to restrict the pledging of shares by our executive officers and directors, which was created in 2021 and most recently amended in 20256. The policy prohibits our executive officers and directors from entering into any transaction whereby the executive officer or director, directly or indirectly, pledges, hypothecates, or otherwise

encumbers more than forsixty (460) percent of shares of common stock held by the individual or more than tefifteen (105) percent of our total outstanding shares of common stock as of the date of the transaction, whichever is lower, as collateral for indebtedness. This restriction extends to any hedging or similar transaction designed to decrease the risks associated with holding our securities.

While we are not a party to these loans, which are full recourse against APCL and each of Drs. Zhang and Luo, respectively, and are secured by pledges of a portion of the shares of our common stock currently held by APCL and each of Drs. Zhang and Luo, if the price of our common stock declines, Drs. Zhang and Luo may be forced by these financial institutions to provide additional collateral for the loans or to sell shares of our common stock held by them in order to remain within the margin limitations imposed under the terms of their loans. Furthermore, the pledged shares of our common stock may be acquired and sold by the lenders. These factors may limit Drs. Zhang and Luos ability to either pledge additional shares of our common stock or sell shares of our common stock held by them as a means to avoid or satisfy a margin call with respect to their pledged shares of our common stock in the event of a decline in our stock price that is large enough to trigger a margin call. Any significant sales of shares of our common stock by one or more of these three lenders could cause the price of our common stock to decline further.