What changed in this filing

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Item 1. Business

2025-03-03 compared with 2024-02-29 · 98 added, 145 removed, 585 unchanged (29% of the section changed)

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Our largest products by net revenues currently include BAQSIMI ® glucagon nasal powder, or BAQSIMI ® , Primatene MIST ® , glucagon, epinephrine, phytonadione, and lidocaine.

In April 2022, the FDA approved our ganirelix acetate injection 250mg/0.5mL prefilled syringe, which we launched in June 2022.

In July 2022, the FDA approved our vasopressin injection, USP 20 Units/mL, 1 mL single-dose vial, which we launched in August 2022.

In May 2022, the FDA approved our regadenoson injection, 0.08mg/mL, 5mL, single-dose prefilled syringe, which we launched in April 2023.

In March 2023, the FDA approved our naloxone hydrochloride nasal spray 4mg, REXTOVY TM , which we plan to launch in the first quarter of 2024.

In June 2023, we completed our acquisition of BAQSIMI ® , the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes, and is currently available in 27 international markets.

In March 2023, the FDA approved our naloxone hydrochloride nasal spray 4mg, REXTOVY TM , utilizing our proprietary device, which we launched in May 2024.

In June 2023, we completed our acquisition of BAQSIMI ® , the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes, and it is currently available in the United States and 26 international markets.

In May 2024, the FDA approved our Albuterol Sulfate Inhalation Aerosol, which we launched in August 2024.

For the years ended December 31, 2024, 2023, and 2022, we recorded net revenues of $732.0 million, $644.4 million, and $499.0 million, respectively.

We recorded net income of $159.5 million, $137.5 million, and $91.4 million for the years ended December 31, 2024, 2023, and 2022, respectively.

We are currently developing a portfolio of generic abbreviated new drug applications, or ANDAs, biosimilar insulin product candidates and proprietary product candidates, which are in various stages of development and target a variety of indications.

Four of the ANDAs and one of the biosimilar insulin candidates are currently on file with the FDA.

We are currently developing a portfolio of generic abbreviated new drug applications, or ANDAs, biologics license applications, or BLAs, including biosimilar insulin product candidates and proprietary product candidates, which are in various stages of development and target a variety of indications.

Four of the ANDAs are currently on file with the FDA.

Our multiple technological capabilities enable the development of technically challenging products with limited competition.

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These acquisitions have strengthened our core injectable and inhalation product technology infrastructure by providing additional manufacturing, marketing, and research and development capabilities, including the ability to manufacture starting materials, API, and other product components.

In 2021, we completed restructuring our Chinese subsidiary, ANP, reducing ANP’s ownership of Hanxin Pharmaceutical Technology Co., Ltd, or Hanxin, to 11.5%.

For more information see “Part II – Item 8.

Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 3 – ANP Restructuring.” As a result of the restructuring, we determined that we have significant influence over Hanxin.

As such, the retained non-controlling investment in Hanxin is accounted for as an equity method investment.

Hanxin continues to be a related party subsequent to the restructuring.

We primarily target products with high technical barriers to market entry, with a particular focus on the injectable and inhalation markets.

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Our capabilities include strong research and development expertise, sophisticated pharmaceutical engineering capabilities, comprehensive manufacturing capabilities (including synthesizing and manufacturing API), a strict quality assurance system, extensive regulatory and clinical experience, and established marketing and distribution relationships.

We believe our vertical integration allows us to achieve better operating efficiencies, accelerated product development, and internal control over product quality.

We believe our vertical integration allows us to achieve better operating

efficiencies, accelerated product development, improved supply chain control, more flexibility in responding to market demands, and internal control over product quality.

● Experienced management team with deep scientific expertise.

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We believe that our scientific and technical expertise, coupled with our management team’s business, legal, regulatory, and business development experience, will enable us to successfully expand our position with respect to our current products and establish a meaningful market position for our product candidates.

Our goal is to be an industry leader in developing, manufacturing, and marketing technically challenging injectable, inhalation and intranasal pharmaceutical products.

We aim to be an industry leader in developing, manufacturing, and marketing technically challenging injectable, inhalation and intranasal pharmaceutical products.

To achieve this goal, we are pursuing the following key strategies:

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We believe that if these product candidates are commercialized, they are likely to face less competition than less technically challenging generic products, which may enable us to earn higher margins for a longer period of time.

We believe that generic competition for these products will likely be limited because of challenges in product development, manufacturing, or sourcing raw materials or APIs.

We believe generic competition for these products will likely be limited because of challenges in product development, manufacturing, or sourcing raw materials or APIs.

● Develop proprietary products.

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We have a demonstrated ability to identify, acquire and integrate pharmaceutical companies, products, and technologies to complement our internal product development capabilities.

Companies we have acquired include, amongst others, (1) International Medication Systems, Limited or IMS, (2) Armstrong

Pharmaceuticals, Inc.

or Armstrong, (3) Nanjing Puyan Pharmaceutical Technology Co., Ltd.

(which we renamed Amphastar Nanjing Pharmaceuticals Co., Ltd.), or ANP, and (4) Merck’s API Manufacturing Business in Éragny-sur-Epte, France, in connection with which, we established our French subsidiary, Amphastar France Pharmaceuticals, S.A.S., or AFP.

Companies we have acquired include, amongst others, (1) International Medication Systems, Limited, or IMS, (2) Armstrong Pharmaceuticals, Inc., or Armstrong, (3) Nanjing Puyan Pharmaceutical Technology Co., Ltd.

(which we renamed Amphastar Nanjing Pharmaceuticals Co., Ltd.), or ANP, and (4) Merck Sharpe & Dohme’s, or Merck’s, API Manufacturing Business in Éragny-sur-Epte, France, in connection with which, we established our French subsidiary, Amphastar France Pharmaceuticals, S.A.S., or AFP.

Products we have acquired include BAQSIMI ® , Cortrosyn ® , and Primatene ® MIST.

We believe that our scientific and managerial expertise and our integration experience have improved the quality of the product lines and companies that we have acquired, which has had, and we believe will continue to have, a positive effect on our results of operations.

For example, in 2018, we received approval from the FDA to manufacture semi-purified heparin at our Chinese subsidiary, ANP.

We plan to have ANP manufacture API for certain other products and product candidates.

We believe that our scientific and managerial expertise and our integration experience have improved the quality of the product lines and

companies that we have acquired, which has had, and we believe will continue to have, a positive effect on our results of operations.

Our Technical Capabilities

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We are focused on developing a broad range of generic and proprietary inhalation and intranasal products utilizing various delivery technologies.

We have expertise in formulating HFA-based MDIs and DPIs, as well as packaging our inhalation drugs in blister packs and other forms which can be used for loading our products into a variety of inhalation devices.

We have expertise in formulating HFA-based MDIs and DPIs, as well as packaging our inhalation drugs in blister packs and other forms that can be used to load our products into various inhalation devices.

As with our injectable products, we maintain compliance with cGMP regulations, which we believe will enable us to obtain regulatory approvals and support commercial supply.

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We have experience using rDNA manufacturing technology, including the genetic engineering of host cells, fermentation to promote cell culture growth, and isolation and purification of the desired protein from the cell culture.

required to ensure that only the desired protein is included in the finished product through each step.

Testing is required to ensure that only the desired protein is included in the finished product through each step.

We believe that this technology will allow us to develop protein and peptide drug products.

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We plan to use our novel formulation with our intranasal epinephrine and other proprietary products.

Finished Pharmaceutical Products

Pharmaceutical Products

Our Marketed Products

We currently manufacture and sell over 25 products in our finished pharmaceutical product segment.

We currently manufacture and sell over 25 products.

The following is a description of products in our existing portfolio.

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Enoxaparin is a difficult to manufacture injectable form of low molecular weight heparin, which is used as an anticoagulant, and has multiple indications, including the prevention and treatment of deep vein thrombosis.

Enoxaparin is difficult to produce in part because the API is not easily obtained or manufactured.

Enoxaparin is difficult to produce in part because the API is not easily manufactured.

We manufacture the API for our enoxaparin product and perform all subsequent manufacturing of the finished product in-house.

REXTOVY TM (naloxone hydrochloride nasal spray) 4mg

REXTOVY TM is a prescription naloxone nasal spray product intended to be used for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

In March 2023, the FDA approved REXTOVY TM , which we plan to launch in the first quarter of 2024.

We sell two versions of naloxone injections indicated for the emergency treatment of known or suspected opioid overdose.

We sell two versions of naloxone injections for the emergency treatment of known or suspected opioid overdose.

We also sell REXTOVY TM , our prescription naloxone nasal spray product delivered using our proprietary device, which is intended to be used for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression.

Other Marketed Products

Other finished pharmaceutical products that we currently market include the following:

Other pharmaceutical products that we currently market include the following:

● Cortrosyn ® (cosyntropin for injection), a lyophilized powder that is indicated for use as a diagnostic agent in the screening of patients with adrenocortical insufficiency;

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● Neostigmine methylsulfate injection, a cholinesterase inhibitor used in the treatment of myasthenia gravis and to reverse the effects of muscle relaxants such as gallamine and tubocurarine;

● Isoproterenol hydrochloride injection, indicated for multiple uses, including mild or transient episodes of heart block that do not require electric shock or pacemaker therapy;

● Isoproterenol hydrochloride injection, indicated for multiple uses, including mild or transient episodes of heart block that do not require an electric shock or pacemaker therapy;

● Ganirelix Acetate Injection, indicated for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation;

● Vasopressin is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.

● Regadenoson is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress.

● Vasopressin, indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.

● Regadenoson, a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress.

● Albuterol Sulfate inhalation aerosol, indicated for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease.

We manufacture and sell two API products, Recombinant Human Insulin, or RHI API, and porcine insulin API, as part of our vertical integration strategy by targeting certain finished products for the injectable insulin market.

However, we also sell RHI API and porcine insulin API to third parties, which helps fund our vertical integration strategy.

Our Product Candidates

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● sophisticated analytical technologies, including characterization and immunogenicity studies for complex molecules, particle engineering, sustained-release technology, peptide, protein and DNA analysis and synthesis.

Biosimial Product Candidates

Biosimilar Product Candidates

Our biosimilar pipeline, with a particular emphasis on interchangeable insulin analogs, targets a high-demand diabetes care sector.

The recent filing of a Biologics License Application, or BLA, for insulin Aspart (AMP-004) was a pivotal step in our biosimilar program.

The filing included using in-house developed technical platforms while navigating a complex regulatory environment while our goal to obtain interchangeable designations.

Further, we are applying our technology platforms to develop additional product candidates in our biosimilar portfolio.

We are preparing for the regulatory submission of three additional interchangeable insulin product candidates, Insulin Aspart Mix (AMP-004m), Insulin Degludec (AMP-025), and Recombinant Human Insulin (AMP-005).

Developed to meet stringent bioequivalence standards, these candidates will support our vision to effectively and efficiently meet the needs of our target markets.

Our planned filings use in-house developed technical platforms while navigating a complex regulatory environment with our goal to obtain interchangeable designations.

We are applying our technology platforms to develop product candidates in our biosimilar portfolio, including three interchangeable insulin product candidates:

Insulin Aspart (AMP-004), Recombinant Human Insulin (AMP-005) and Insulin Degludec (AMP-025).

Developed to meet stringent bioequivalence standards, these candidates are expected to support our vision to effectively and efficiently meet the needs of our target markets.

Additionally, we are developing a biosimilar product outside of our insulin portfolio, AMP-028.

This product is expected to leverage our API facilities to participate in a large market without any interchangeable biosimilars.

A rigorous development strategy reinforces our commitment to developing biosimilar products and utilizes our vertically integrated structure when possible.

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These skills include new chemical entity assessment, peptide and protein synthesis technology, complex formulation development, characterization analysis, and immunogenicity studies.

With respect to our proprietary pipeline strategy, we currently have proprietary drug candidates at various development stages that leverage our various technical capabilities.

The following paragraph summarizes our proprietary product candidates for which NDAs have been filed with the FDA.

With respect to our proprietary pipeline strategy, we currently have proprietary drug candidates at various development stages that leverage our various technical capabilities including:

Intranasal epinephrine

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These product candidates incorporate multiple indications utilizing a wide variety of our technical capabilities.

We manufacture and sell two API products, Recombinant Human Insulin, or RHI API, and porcine insulin API, as a result of our acquisition of Merck Sharpe & Dohme’s, or Merck’s, API manufacturing business in Éragny-sur-Epte, France, or the Merck API Transaction, in April 2014.

The acquisition aimed to enhance our vertical integration strategy as we target certain finished products for the injectable insulin market.

However, we continue to sell RHI API and porcine insulin API to third parties, which helps fund our vertical integration strategy.

BAQSIMI ® Acquisition

On June 30, 2023, we completed our acquisition of BAQSIMI ® .

BAQSIMI ® is the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes and is currently available in 27 international markets.

On June 30, 2023, we completed our acquisition of BAQSIMI ® , the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes and which is currently available in 26 international markets.

In connection with the acquisition of BAQSIMI ® in June 2023, we entered into a Transition Service Agreement, or TSA, with Eli Lilly & Company, or Lilly, pursuant to which Lilly agreed to provide certain services to us to support the transition of BAQSIMI ® operations, including with respect to the conduct of certain clinical, regulatory, medical affairs, and commercial sales channel activities.

Over the course of 2024, we assumed responsibility of these activities from Lilly on a country-by-country basis.

As of January 1, 2025, the TSA has been completed and we distribute and manage the BAQSIMI ® supply chain in all countries where it is available.

The acquisition of BAQSIMI ® , builds upon our commercial intranasal product portfolio, provides us with a branded product with growing sales and strong gross margins, and expands our international footprint into 26 new countries.

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A significant portion of our customer shipments in any fiscal year relates to orders received and shipped in that fiscal year, generally resulting in a low product backlog relative to total shipments at any time.

As of December 31, 2023, our backlog was minimal, partially as a result of competitor shortages and supplier constraints.

We had no significant backlog as of December 31, 2024.

Historically, our backlog has not been a meaningful indicator of our ability to achieve any particular level of overall revenue or financial performance.

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We continue to expand our facility in Nanjing, China, and expect further significant investment in this facility.

Our API manufacturing business in Éragny-sur-Epte, France, which we acquired in April 2014, manufactures porcine insulin API and RHI API, and we expect to continue the current site activities.

We have completed a project to modify our current facility in France to increase our internal manufacturing capabilities allowing us to take over the manufacture of inclusion bodies, which are our RHI API’s starting material.

The project was completed in 2020 with a cost of $40.1 million.

Our API manufacturing facility in Éragny-sur-Epte, France, manufactures porcine insulin API, RHI API, and the API for our AMP-028 biosimilar candidate, and we expect to continue the current site activities.

We believe that our current manufacturing capacity is adequate for the near term.

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Obtaining the required regulatory approvals to use alternative suppliers may be a lengthy and uncertain process during which we could lose sales.

If our primary suppliers become unable or unwilling to perform, we could experience protracted delays or interruptions in the supply of materials that would ultimately delay our manufacture of products for commercial sale, which could materially and adversely affect our development programs, commercial activities, operating results and financial condition.

We depend on contract manufacturing organizations, or CMO, for the supply of BAQSIMI ® which are subject to stringent FDA requirements.

If our CMO experience difficulties in acquiring sufficient quantities of required materials or products from their existing suppliers or if our CMO are found to be non-compliant with the FDA’s or other regulatory agencies quality system regulation, cGMP, or other applicable laws or regulations, we would be required to find alternative CMO.

Obtaining the required regulatory approvals to use alternative CMO may be a lengthy and uncertain process during which we could lose sales.

If our CMO become unable or unwilling to perform, we could experience protracted delays or interruptions in the supply of BAQSIMI ® which could materially and adversely affect our commercial activities, operating results and financial conditions.

If our suppliers or our CMO encounter problems during manufacturing, establishing additional or replacement suppliers for these materials may take a substantial period of time, as suppliers must be approved by the FDA.

If our primary suppliers become unable or unwilling to perform, we could experience protracted delays or interruptions in the supply of materials that would ultimately delay our manufacturing of products for commercial sale, which could materially and adversely affect our development programs, commercial activities, operating results and financial condition.

We depend on contract manufacturing organizations, or CMOs, for the supply of BAQSIMI ® which are subject to stringent FDA requirements.

If our CMOs experience difficulties in acquiring sufficient quantities of required materials or products from their existing suppliers or if our CMOs are found to be non-compliant with the FDA’s or other regulatory agencies quality system regulation, cGMP, or other applicable laws or regulations, we would be required to find alternative CMOs.

Obtaining the required regulatory approvals to use alternative CMOs may be a lengthy and uncertain process during which we could lose sales.

If our CMOs become unable or unwilling to perform, we could experience protracted delays or interruptions in the supply of BAQSIMI ® which could materially and adversely affect our commercial activities, operating results and financial conditions.

If our suppliers or our CMOs encounter problems during manufacturing, establishing additional or replacement suppliers for these materials may take a substantial period of time, as suppliers must be approved by the FDA.

Further, a significant portion of our raw materials may be available only from foreign sources, which are subject to the risks of doing business abroad.

For example, heparin USP is the starting material for the production of the API in our enoxaparin product.

We have established a supply chain for heparin that originates in China and have implemented validated technology processes designed to screen and test incoming starting material, which include methods currently required

However, the FDA has required companies importing heparin to test imported heparin using specific screening methods to detect certain contaminants and it has increased its scrutiny of Chinese facilities that produce heparin for the U.S.

For example, in August 2008, the FDA inspected two facilities in China belonging to suppliers in our heparin supply chain and issued warning letters, one of which needed to be resolved as a precondition to approving the ANDA for our enoxaparin product candidate in September 2011.

In 2018, we received approval from the FDA for the manufacture of semi-purified heparin at ANP.

Department of Agriculture, or USDA, the Animal and Plant Health Inspection Service, or APHIS, and the Veterinary Services regulates the importation of animals and animal-derived materials into the U.S.

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Some of our raw materials sourced from foreign sources are subject to import regulations and permit requirements, including from the USDA.

Recently, USDA enhanced its African swine fever, or ASF, surveillance efforts, including placing restrictions on the importation of pork products from affected countries, such as China, where the first cases of ASF were reported in August 2018.

While ASF does not affect human health, it is a highly contagious and deadly disease to pig populations.

We anticipate that our current supply of heparin USP in the United States is useable and sufficient for our manufacturing needs for the foreseeable future, and we are evaluating the use of heparin USP produced at our ANP facility.

If we are unable to import raw materials, rely upon existing supplies of raw materials or manufacture raw materials in sufficient amounts for our manufacturing needs, we may be required to find alternative suppliers or sources of such materials, which would require prior FDA approval for such alternative suppliers or sources of such materials, which would disrupt or delay the manufacturing of our products.

Similarly, on December 27, 2020, the American Innovation in Manufacturing Act of 2020, or AIM Act, was enacted.

The AIM Act directs the United States Environmental Protection Agency to address usage of hydrofluorocarbons, or HFC, by reducing production and consumption of certain HFCs.

The AIM Act directs the United States Environmental Protection Agency to address usage of hydrofluorocarbons, or

HFC, by reducing production and consumption of certain HFCs.

One of our products, Primatene MIST ® , utilizes HFCs subject to the AIM Act’s reduction mandate.

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There can be no assurance that we will be able to acquire adequate supplies of HFCs for current and future commercialization of our products as a result of the AIM Act or other similar statutes and regulations.

Moreover, changes to the ingredients of our proprietary and generic products requires FDA approval and there can be no assurance that we will be able to obtain such approval or the timing of such approval.

ANP currently manufactures heparin sodium for our enoxaparin product, isoproterenol and hyaluronidase for Amphastar’s current products, and we plan to have ANP manufacture APIs and starting materials for APIs for certain other products and product candidates.

Moreover, changes to the ingredients of our proprietary and generic products require FDA approval and there can be no assurance that we will be able to obtain such approval or the timing of such approval.

ANP currently manufactures heparin sodium for our enoxaparin product, isoproterenol, hyaluronidase, and medroxyprogesterone for Amphastar’s current products, and we plan to have ANP manufacture APIs and starting materials for APIs for certain other products and product candidates.

Sales and Marketing

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We also have relationships with major specialty distributors, wholesalers and retailers who distribute pharmaceutical products nationwide.

Eli Lilly & Company, or Lilly, currently manufactures and sells BAQSIMI ® on our behalf pursuant to the terms of the Transition Services Agreement, or TSA.

The following table provides information regarding the percentage of our net revenues that is derived from each of our major customers and partners:

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Cardinal Health, Inc.

Our marketing department is responsible for establishing and maintaining contracts and relationships with the group purchasing organizations, distributors, retailers, wholesalers and our sales force is focused on promoting BAQSIMI ®

with healthcare professionals.

One or more of our proprietary product candidates may require deployment of a sales force either directly or through a strategic partner.

We face and will face significant competition for our products and product candidates from pharmaceutical companies that focus on proprietary and generic injectable and inhalation markets such as Pfizer, Inc., Sagent Pharmaceuticals, Inc., Akorn, Inc., Sandoz Inc., Viatris Inc., Fresenius Kabi USA, Nexus Pharmaceuticals, Apotex Corp, Amneal Biosciences, American Regent Inc., Hikma Pharmaceuticals USA, Inc., Par Pharmaceuticals, Cipla USA Inc., Meitheal Pharmaceuticals, Dr.

Reddy’s Laboratories, Inc., Sun Pharmaceuticals, Inc., Xeris, Pharmaceuticals, Novo Nordisk, Medefil Inc., Accord Healthcare, Eugia Pharma, Amring Pharmaceuticals, Bausch Health, Zydus Pharmaceuticals USA Inc., AuroMedics Pharma LLC, and Teva Pharmaceutical Industries Ltd.

We face and will face significant competition for our products and product candidates from pharmaceutical companies that focus on proprietary and generic injectable and inhalation markets such as Pfizer, Inc., BPI Labs, Lupin Pharmaceuticals, Inc., Viatris Inc., Fresenius Kabi USA, Apotex Corp, American Regent Inc., Hikma Pharmaceuticals USA, Inc., Par Pharmaceuticals, Cipla USA Inc., Meitheal Pharmaceuticals, Dr.

Reddy’s Laboratories, Inc., Xeris Pharmaceuticals, Medefil Inc., Accord Healthcare, and Teva Pharmaceutical USA Inc.

Competition in the generic pharmaceutical industry has increased as producers of branded products have entered the business by creating generic drug subsidiaries, purchasing generic drug companies, or licensing their products to generic manufacturers prior to patent expiration and/or as their patents expire.

Therefore, our competitors also include the innovator companies of our generic drug products.

For example, enoxaparin is currently marketed by Sanofi S.A., or Sanofi, under the brand name Lovenox ® .

Sanofi also markets its authorized generic enoxaparin product through its subsidiary, Winthrop.

Fresenius Kabi USA, Apotex Corp., Zydus Pharmaceuticals USA Inc., Sandoz, Meithael Pharmaceuticals, Inc., and others also market a generic version of enoxaparin.

Other companies may have filed an ANDA with the FDA for its generic version of enoxaparin.

The presence of these current and prospective competitive products may have an adverse effect on our market share, revenue and gross profit from our enoxaparin product.

The presence of these current and prospective competitive products may have an adverse effect on our market share, revenue and gross profit from our products.

Similarly, we will face significant competition for our proprietary product candidates.

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There are two drug approval processes under the FFDCA — an ANDA approval process for generic drugs and an NDA approval process for new drugs that cannot be approved in ANDAs.

For drugs that are “biological products” within the meaning of the PHSA, there are two different approval processes — a biological license application, or BLA, approval process for original biological products and a biosimilar application approval process for biosimilar products that are approved based on their similarity to biologicals that were previously approved in BLAs.

For drugs that are “biological products” within the meaning of the PHSA, there are two different approval processes — a biological

license application, or BLA, approval process for original biological products and a biosimilar application approval process for biosimilar products that are approved based on their similarity to biologicals that were previously approved in BLAs.

The ANDA Approval Process

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GDUFA funding is intended to increase the ability of the FDA to perform critical program functions and to reduce costs.

Under the GDUFA, the FDA has specific goals for reviewing ANDA

applications.

For example, as part of GDUFA II, the goal of the FDA is to complete the review of 90% of original ANDA applications within 10 months from filing of the ANDA.

Under the GDUFA, the FDA has specific goals for reviewing ANDA applications.

For example, as part of GDUFA II and GDUFA III, the goal of the FDA is to complete the review of 90% of original ANDA applications within 10 months from filing of the ANDA.

Under previous GDUFA authorizations, the average time for sponsors to obtain FDA approval of ANDAs was 32-34 months post-filing.

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The FDA may refuse to accept the filing of an ANDA that is not substantially complete or may determine during substantive review of the ANDA that additional information, such as an additional bioequivalence study, is required to support approval.

Such a determination may affect an applicant’s first to file status and eligibility for 180-day exclusivity.

Such a determination may affect an applicant’s first to

file status and eligibility for 180-day exclusivity.

The Medicare Prescription Drug Improvement and Modernization Act of 2003, or the MMA, provides that the 180-day exclusivity delay ends 180 days after the first commercial marketing of the ANDA product.

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ANDA approvals can also be delayed by orphan drug exclusivity, pediatric exclusivity and exclusivity for certain new antibiotic drugs.

The FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition,

which is generally a disease or condition that affects fewer than 200,000 individuals in the U.S.

The FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the U.S.

or more than 200,000 individuals in the U.S.

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This six-month exclusivity, which runs from the end of other exclusivity protection or patent delay, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued written request for such a study.

The FFDCA also provides exclusivity for certain antibiotic drugs for serious or life-threatening infections that FDA designates as “qualified infectious disease products.” This exclusivity extends other exclusivities for the same drug by five years, but does not extend patent-related delays in approval.

The FFDCA also provides exclusivity for certain antibiotic drugs for serious or life-threatening infections that the FDA designates as “qualified infectious disease products.” This exclusivity extends other exclusivities for the same drug by five years, but does not extend patent-related delays in approval.

In 2017, the FDA Reauthorization Act of 2017, or FDARA, was passed, which created a new pathway to allow the FDA to expedite the development and review of an ANDA for a drug that is designated as a Competitive Generic Therapy, or CGT.

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Once assigned CGT designation by the FDA, the FDA may take various actions to help expedite the development and review process.

This includes priority granting and expediting review during Product Development and Pre-Submission Meetings, Mid-Review Cycle Meetings and provide for a more coordinated review of ANDA’s with CGT.

This includes priority granting and expediting review during Product Development and Pre-Submission Meetings, Mid-Review Cycle Meetings and providing for a more coordinated review of ANDA’s with CGT.

As part of the FDARA, a new type of 180-day marketing exclusivity period for ANDA applicants with CGT designation has been created.

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A biosimilar application must contain information demonstrating (1) biosimilarity to the reference product, (2) sameness of strength, dosage form, route of administration and mechanism(s) of action with the reference product (where known), (3) approval of the reference product for the indication(s) proposed for the biosimilar product and (4) appropriate manufacturing facilities.

FDA will approve the application based on a finding of biosimilarity or

interchangeability with the reference product.

A finding of biosimilarity must be based on (1) a demonstration that the products are “highly similar” notwithstanding minor differences in clinically inactive components, (2) animal studies, including an assessment of toxicity, and (3) a clinical study or studies (including an assessment of immunogenicity and pharmacokinetics or pharmacodynamics) sufficient to show the safety, purity and potency of the proposed product for one or more “appropriate” conditions of use for which licensure is sought and for which the reference product is licensed, unless FDA waives a specific requirement.

The FDA will approve the application based on a finding of biosimilarity or interchangeability with the reference product.

The definition of “biosimilar” requires that there be no clinically meaningful differences between the biosimilar and reference product with regard to safety, purity and potency.

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The PHSA provides a number of exclusivity protections for reference products that may delay submission and approval of biosimilar applications.

The PHSA delays submission of a biosimilar application until four years after the date on which the reference product was first licensed and delays final approval of a biosimilar application until 12 years after the first licensure of the reference product.

The PHSA delays submission of a biosimilar application until four years after the date on

which the reference product was first licensed and delays final approval of a biosimilar application until 12 years after the first licensure of the reference product.

The first-licensure requirement precludes an additional period of exclusivity for a supplement to the original application for the reference product.

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Applications for biological products, including proteins, must now be approved under the PHSA rather than under the FFDCA.

The BPCIA provides a grandfather exception for biologics falling within a product class for which FDA has approved an application under the FFDCA.

Applications for approval of these types of proteins may be submitted under the FFDCA until March 23, 2020, unless there is a biological product licensed under the PHSA that could serve as a reference product for a biosimilar application.

The BPCIA provides a grandfather exception for biologics falling within a product class for which the FDA has approved an application under the FFDCA.

Under the PHSA, patents are not listed in the Orange Book and companies submitting biosimilar applications are not required to submit patent certifications.

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● completion of preclinical laboratory and animal testing in compliance with the FDA’s GLP regulations;

● submission to the FDA of an IND for human clinical testing, which must satisfy FDA and become effective before human clinical trials may begin;

● submission to the FDA of an IND for human clinical testing, which must satisfy the FDA and become effective before human clinical trials may begin;

● performance of adequate and well-controlled human clinical trials to establish the efficacy of the proposed drug product for each intended use;

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The Center that regulates that portion of the product that generates the PMOA becomes the lead evaluator.

If there are two independent modes of action, neither of which is subordinate to the other, the FDA makes a determination as to which Center to assign the product based on consistency with other combination products raising similar types of safety and effectiveness questions or to the Center with the most expertise in evaluating the most significant safety and effectiveness questions raised by the combination product.

and effectiveness questions raised by the combination product.

● W hen evaluating an application, a lead Center may consult other Centers and apply the standards that would be applicable but still retain complete reviewing authority, or it may collaborate with another Center, by which the Center assigns review of a specific section of the application to another Center, delegating its review authority for that section.

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CDRH will provide input to CDER (or CBER) on the device aspects of the combination.

We can provide no assurance that any of our combination products will be approved by FDA in a timely fashion, if at all.

We can provide no assurance that any of our combination products will be approved by the FDA in a timely fashion, if at all.

● L ike their constituent products—e.g., drugs/biologics and devices—combination products are highly regulated and subject to a broad range of post marketing requirements including cGMPs, adverse event reporting, periodic reports, labeling and advertising and promotion requirements and restrictions, market withdrawal and recall.

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Maintaining substantial compliance with appropriate federal, state and local statutes and regulations requires the expenditure of substantial time and financial resources.

Drug and biologic manufacturers are required to register their establishments with the FDA and certain state agencies.

Drug and biologic manufacturers are required to register their

establishments with the FDA and certain state agencies.

After approval, the FDA and these state agencies conduct periodic unannounced inspections to ensure continued compliance with ongoing regulatory requirements.

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In addition, the FDA strictly regulates labeling, advertising, promotion and other types of information on products that are placed on the market.

activities, information provided to the media and information provided over the Internet.

There are numerous regulations and policies that govern various means for disseminating information to health-care professionals, as well as consumers, including industry sponsored scientific and educational activities, information provided to the media and information provided over the Internet.

Drugs or biologics may be promoted only for the approved indications and in accordance with the provisions of the approved label.

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The requirements governing marketing authorization, pricing and reimbursement vary widely from country to country.

At present, foreign marketing authorizations are applied for at a national level, although within the European Union registration procedures are available to companies wishing to market a product in more than one European Union member state.

At present, foreign marketing authorizations are applied for at a national level, although within the European Union, or EU, registration procedures are available to companies wishing to market a product in more than one EU member state.

The regulatory authority generally will grant marketing authorization if it is satisfied that we have presented it with adequate evidence of safety, quality and efficacy.

Prescription Drug Wrap-Up

When Congress passed the FFDCA in 1938, it required that “new drugs” be approved based on their safety.

In 1962, Congress amended the FFDCA to require that sponsors demonstrate that new drugs are effective, as well as safe, in order to receive FDA approval.

We refer to these provisions as the “1962 Amendments.” The 1962 Amendments also required the FDA to conduct a retrospective evaluation of the efficacy of the drug products that the FDA approved between 1938 and 1962 on the basis of safety alone.

The FDA contracted with the National Academy of Science/National Research Council, or the NAS/NRC, to make an initial evaluation of the efficacy of many of these drug products.

The FDA’s administrative implementation of the NAS/NRC reports was called the Drug Efficacy Study Implementation, or DESI.

Drugs that were not subject to applications approved between 1938 and 1962 were not subject to DESI review.

For a period of time, the FDA did not challenge the marketing of these drugs without approval.

In 1984, however, spurred by serious adverse reactions to one of these products and concerns expressed by Congress, FDA undertook an assessment of the products under an initiative known as the “Prescription Drug Wrap-Up.” Most of these drugs contain active ingredients that were first marketed prior to the enactment of the FFDCA.

One of our marketed pharmaceutical products falls within this category.

The FDA has asserted that all drugs subject to the Prescription Drug Wrap-Up are on the market illegally unless they fall within two “grandfather” exceptions to the new drug definition.

The first is a provision in the new drug definition exempting drugs that were on the market prior to the passage of the FFDCA and that contain the same representations concerning the conditions of use as they did prior to passage of the FFDCA.

The 1962 Amendments also exempt drugs that were not new drugs prior to the passage of the 1962 Amendments and that have the same composition and labeling as they had prior to the passage of the 1962 Amendments.

The FDA and the courts have interpreted these two exceptions very narrowly.

Therefore, the FDA could commence enforcement action at any time regarding our unapproved

prescription product.

The FDA requested us to discontinue the manufacturing and distribution of our epinephrine injection, USP vial product, which has been marketed under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program.

We discontinued selling this product in the second quarter of 2017.

In April 2020, the FDA granted approval of our Epinephrine Injection USP 30mg/30mL Multiple Dose Vial.

Additionally, the FDA granted approval of our ANDAs for atropine sulfate injection, dextrose injection, morphine sulfate injection, and epinephrine injection single dose prefilled syringe in October 2020, March 2021, April 2021, and August 2022, respectively.

The FDA has adopted a risk-based enforcement policy that prioritizes enforcement of new drug requirements for these and other unapproved drugs that pose safety concerns, lack evidence of efficacy, prevent patients from pursuing effective therapies, are marketed fraudulently, violate other provisions of the FFDCA, such as cGMP requirements, or directly compete with approved drugs.

The FDA has indicated that approval of an NDA for one drug within a class of drugs marketed without FDA approval may trigger agency enforcement of the new drug requirements.

Once the FDA issues an approved NDA for one of the drug products at issue or completes the efficacy review for that drug product, it may require other manufacturers to also obtain approval for that same drug in order to continue marketing it in the United States.

While the FDA generally provides sponsors a one-year grace period, the agency is not statutorily required to do so.

USDA Animal and Plant Health Inspection Service

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In particular, a USDA veterinary permit is required for importation of materials derived from animals or exposed to animal-source materials.

Recently, USDA enhanced its ASF surveillance efforts, including restrictions on importation of pig-derived products from affected countries and testing for the ASF virus.

Recently, USDA enhanced its African swine fever, or ASF, surveillance efforts, including restrictions on importation of pig-derived products from affected countries and testing for the ASF virus.

While ASF does not affect human health, it is a highly contagious and deadly disease to local pig populations.

ASF is currently widespread and endemic in various parts of Africa and Sardinia.

In recent years, ASF has been reported in parts of the European Union and in China, where the first cases of ASF were reported in August 2018.

In recent years, ASF has been reported in parts of the EU and in China, where the first cases of ASF were reported in August 2018.

Complying with additional requirements, such as additional analytical data and documentation of processing flow, may be required for obtaining an import permit for certain materials from affected countries.

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In addition, the federal government has prosecuted companies under the FCA in connection with off-label promotion of products.

Our current and future activities relating to the reporting of wholesale or estimated retail prices of our products, the reporting of

discount and rebate information and other information affecting federal, state and third-party reimbursement of our products, and the sale and marketing of our products may be subject to scrutiny under these laws.

While we are unaware of any current matters, we are unable to predict whether we will be subject to actions under the False Claims Act or a similar state law, or the impact of such actions.

Our current and future activities relating to the reporting of wholesale or estimated retail prices of our products, the reporting of discount and rebate information and other information affecting federal, state and third-party reimbursement of our products, and the sale and marketing of our products may be subject to scrutiny under these laws.

While we are unaware of any current matters, we are unable to predict whether we will be subject to actions under the FCA or a similar state law, or the impact of such actions.

However, the costs of defending such claims, as well as any sanctions imposed, could significantly affect our financial performance.

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The payments and transfer of value required to be reported include the cost of meals provided to a physician, travel reimbursements and other transfers of value provided as part of contracted services, including speaker programs, advisory boards, consultation services and clinical trial services.

The statute requires the federal government to make reported information available to the public.

The statute requires the federal government to make

reported information available to the public.

Failure to comply with the reporting requirements can result in significant civil monetary penalties ranging from $1,406 to $14,067 for each payment or other transfer of value that is not reported (up to a maximum per annual report of $211,008) and from $14,067 to $140,674 for each knowing failure to report (up to a maximum per annual report of $1,406,728).

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We are subject to federal, state and local environmental laws and regulations, both U.S.

and foreign, including those promulgated by the Occupational Safety and Health Administration, the Environmental Protection Agency, the

Department of Health and Human Services and the Air Quality Management District, which govern activities and operations that may have adverse environmental effects such as discharges to air, soil and water, as well as handling and disposal practices for solid and hazardous wastes.

and foreign, including those promulgated by the Occupational Safety and Health Administration, the Environmental Protection Agency, the Department of Health and Human Services and the Air Quality Management District, which govern activities and operations that may have adverse environmental effects such as discharges to air, soil and water, as well as handling and disposal practices for solid and hazardous wastes.

Because we own and operate real property, these laws impose strict liability for the costs of cleaning up, and for damages resulting from, sites of past spills, disposals or other releases of hazardous substances and materials.

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Similarly, on December 27, 2020, the American Innovation in Manufacturing Act of 2020, or AIM Act, was enacted.

The AIM Act directs the United States Environmental Protection Agency to address usage of hydrofluorocarbons, or HFC, by reducing production and consumption of certain HFCs.

The AIM Act directs the United States Environmental Protection Agency to address usage of hydrofluorocarbons, or

HFC, by reducing production and consumption of certain HFCs.

One of our products, Primatene MIST ® , utilizes HFCs subject to the AIM Act’s reduction mandate.

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Compliance with these laws, rules and regulations regarding privacy, security and protection of employee data could result in higher compliance and technology costs for us, as well as significant fines, penalties and damage to our global reputation and our brand as a result of non-compliance.

In November 2013, the federal Drug Supply Chain Security Act, or the DSCSA, became effective in the United States, mandating an industry-wide, national serialization system for pharmaceutical packaging with a ten-year phase-in process.

By November 2018, all manufacturers and re-packagers were required to mark each prescription drug package with a unique serialized code.

Each of Amphastar and our U.S.-based subsidiaries subject to or covered by DSCSA comply with the new requirements.

In addition, under the DSCSA, we are required by November 2024, to provide to downstream trading partners, serial number specific transaction details.

This may require additional modification to Amphastar and our U.S.-based subsidiaries’ manufacturing sites.

In 2013, the federal Drug Supply Chain Security Act, or the DSCSA, became effective in the United States, mandating an industry-wide, national serialization system for pharmaceutical packaging with a ten-year phase-in process.

By 2018, all manufacturers and re-packagers were required to mark each prescription drug package with a unique serialized code.

Each of Amphastar and our U.S.-based subsidiaries is subject to or covered by DSCSA and is required to comply with such requirements.

In addition, under the DSCSA, we are required to provide to downstream trading partners, serial number specific transaction details by May 2025, which has required additional modification to Amphastar and our U.S.-based subsidiaries’ manufacturing sites.

Additionally, should any subsidiary that is not subject to or covered by the DSCSA become subject to or covered by the DSCSA, we may be required to modify our manufacturing sites to comply with the rules and regulations.

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We currently own more than 100 issued patents globally, including several patents covering BAQSIMI ® , U.S.

Patent Number 10,213,487 and 10,765,602 are listed in the U.S.

Patent Number 10,213,487, which is listed in the U.S.

FDA Orange Book, and we own a U.S.

patent covering the HFA version of Primatene MIST ® :

patent covering the HFA version of Primatene MIST ® , U.S.

Patent Number 8,367,734, which is listed in the U.S.

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For our product candidates that are not intended to be generic products, we may seek to obtain patent rights or rely on trade secret protection.

We may not be able to obtain patent or other forms of protection for inventions or other intellectual property developed by our officers, employees, or consultants because we might not have been the first to file or to invent the patentable technology or others may have independently developed similar or alternative technology.

We may not be able to obtain patent or other forms of

protection for inventions or other intellectual property developed by our officers, employees, or consultants because we might not have been the first to file or to invent the patentable technology or others may have independently developed similar or alternative technology.

The majority of our products and product candidates are not currently covered by any U.S.

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As of December 31, 2024, we had 2,028 full-time employees in the United States, China, and France.

Of these employees, 29 hold Ph.D.’s, and an additional 118 employees hold a master’s degree or other post-graduate degrees.

Of these employees, approximately 150 employees hold post-graduate degrees.

We consider our employees’ intellectual capital an essential driver of our business and key to our future prospects.

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Our total rewards philosophy recognizes the contributions of our workforce by offering competitive compensation and benefits packages.

We provide employees with compensation packages that include base salary, annual incentive bonuses, and long-term equity awards.

We provide employees with compensation packages that include base salary and annual incentive bonuses.

Certain employees are also eligible for long-term equity awards.

We also provide comprehensive employee benefits, which vary by country and region, such as life and health insurance, health savings accounts, paid time off, an Employee Stock Purchase Program, and a 401(k) plan.

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Our telephone number is (909) 980-9484.

Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, are available free of charge as soon as reasonably practicable after we electronically file them with, or furnish them to, the SEC.

Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are available free of charge as soon as reasonably practicable after we electronically file them with, or furnish them to, the SEC.

You can access our filings with the SEC by visiting http://www.amphastar.com.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business