What changed in this filing

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Item 1. Business

2026-02-26 compared with 2025-03-03 · 201 added, 97 removed, 586 unchanged (34% of the section changed)

We are a bio-pharmaceutical company focusing primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as insulin active pharmaceutical ingredient, or insulin API products.

We currently manufacture and sell over 25 products, the overwhelming majority of which are prescription pharmaceuticals.

Since December 2018, we have sold our patented Primatene MIST ® using a new hydrofluoroalkanes, or HFA, formulation as our sole over-the-counter product.

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

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

We are a biopharmaceutical company focusing on developing, manufacturing, and commercializing technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as active pharmaceutical ingredient, or API products.

We currently manufacture and sell over 25 prescription pharmaceutical products, and an over-the-counter product, Primatene MIST ® .

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

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.

In August 2025, the FDA approved our iron sucrose injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, which we launched in the August 2025.

In December 2025, the FDA approved our teriparatide injection, USP 560mcg/2.24mLsingle-patient-use prefilled pen, which we launched in the December 2025.

In February 2026, the FDA approved our Ipratropium Bromide HFA inhalation aerosol, 17 mcg/actuation, which we plan to launch early in the second quarter of 2026.

For the years ended December 31, 2025, 2024, and 2023, we recorded net revenues of $719.9 million, $732.0 million, and $644.4 million, respectively.

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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.

One ANDA and one biosimilar insulin candidate are currently on file with the FDA.

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

These capabilities include characterizing complex molecules, analyzing and synthesizing peptides and proteins, conducting immunogenicity studies, engineering particles, and improving drug delivery through sustained-release technology.

These technological capabilities have enabled us to produce bioequivalent versions of complex drugs and support the development and manufacture of a broad range of dosage formulations, including solutions, emulsions, suspensions, and lyophilized products, as well as products administered via pre-filled syringes, vials, nasal sprays, metered-dose inhalers, or MDIs, and dry powder inhalers, or DPIs.

Our primary strategic focus is developing and commercializing products with high technical barriers to market entry.

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It uses pressurized gas, historically chlorofluorocarbons, or CFCs, and more recently HFAs, to release its dose when the patient activates the device.

The DPI, which does not rely on a propellant, is also widely used.

As in the case of injectables, there are significant technical barriers to manufacturing inhalation products.

The evolution of inhalation delivery technologies from nebulizers and CFCs to HFAs and DPIs has required manufacturers of inhalation products to re-formulate their products, which in many cases may require technical engineering capabilities, additional regulatory approvals and modified delivery devices.

Additionally, the development of generic HFA and DPI products requires bioequivalence studies for FDA approval.

The evolution of inhalation delivery technologies from nebulizers and CFCs to HFAs has required manufacturers of inhalation products to re-formulate their products, which in many cases may require technical engineering capabilities, additional regulatory approvals and modified delivery devices.

Additionally, the development of generic HFA products requires bioequivalence studies for FDA approval.

Our Strengths

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● Robust portfolio of products and product candidates.

We have over 25 commercial products and over 20 product candidates at different development stages, representing our longer-term growth opportunities.

We market over 25 commercial products and are developing over 10 product candidates.

Our portfolio includes complex generics, biosimilars, and proprietary products at various stages of development.

Consistent with our long-term strategy, we continue to expand into higher-value proprietary and biosimilar programs, which we expect will represent an increasing proportion of our pipeline over time.

● Advanced technical capabilities and multiple delivery technologies.

We have developed multiple advanced technical capabilities that we incorporate into the development of our products and product candidates, including characterization of complex molecules, peptide and protein analysis and synthesis, immunogenicity studies, particle engineering, and sustained-release technology.

In addition, we apply these capabilities across our injectable, inhalation, and intranasal delivery technologies.

Our injectable delivery technologies enable us to develop and manufacture generic and proprietary injectables in normal solution, lyophilized, suspension, jelly, emulsion forms, and pre-filled syringes.

Our inhalation technologies cover a variety of delivery methods, including DPIs and HFA formulations of MDIs.

We have developed multiple advanced technical capabilities that we incorporate into the development of our products and product candidates.

These capabilities include characterization of complex molecules, peptide and protein analysis and synthesis, immunogenicity studies, particle engineering, and sustained-release technology.

We apply these capabilities across multiple delivery platforms, including injectable, inhalation (MDI), and intranasal delivery technologies.

We also develop and utilize prefilled-pen injection delivery systems to support our insulin and other injectable programs, enabling consistent dosing performance and compatibility with a range of biologic and peptide formulations.

Our inhalation technologies cover a variety of delivery methods, including HFA formulations of MDIs.

Intranasal technology can offer a non-invasive and convenient route of drug delivery systems.

It can offer the advantage of drug bioavailability by bypassing the effect of the first-pass metabolism and can allow drugs to achieve a more rapid and efficient therapeutic effect.

It can offer the advantage of drug bioavailability by bypassing the effect of the first-pass metabolism and can allow drugs to achieve a more rapid and efficient

therapeutic effect.

These technical capabilities form the foundation of our strategy to develop products with high barriers to market entry targeting a wide range of indications.

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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, improved supply chain control, more flexibility in responding to market demands, 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.

We aim 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 commercializing technically challenging injectable, inhalation and intranasal pharmaceutical products.

In recent years, we have shifted our development focus from primarily complex generics toward proprietary and biosimilar products, reflecting our long-term strategy to expand into higher-value, innovative-driven programs.

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

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Assuming we successfully develop and obtain regulatory approvals, we plan to commercialize our product candidates and diversify our revenue sources.

We have over 20 product candidates in various stages of development, including generic ANDAs or New Drug Applications, or NDAs, biosimilar product candidates, and proprietary product candidates.

We have over 10 product candidates in various stages of development, including generic ANDAs, New Drug Applications, NDAs, biosimilar product candidates, and proprietary product candidates.

We also expect to expand our internal sales and marketing capabilities and, in some cases, enter into strategic alliances with other pharmaceutical companies to drive market penetration for our product candidates.

● Focus on complex generic product opportunities.

We believe that we have significant opportunities for growth driven by our technical expertise in developing generic product candidates with high technical barriers to market entry.

● Complex generic product opportunities.

We believe that we have opportunities for growth driven by our technical expertise in developing generic product candidates with high technical barriers to market entry.

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.

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● Develop proprietary products.

We currently have four proprietary product candidates at various stages of development, targeting a broad range of indications.

We currently have several proprietary product candidates at various stages of development, targeting a broad range of indications.

We believe that proprietary products tend to face less competition than generic products due to market exclusivity, intellectual property protection, and other barriers to entry.

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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.

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.

● Proprietary product licensing.

We have licensed several peptide proprietary product candidates from Nanjing Anji Biotechnology Co., Ltd., or Anji, and Nanjing Hanxin Pharmaceutical Technology Co., Ltd., or Hanxin.

We believe we can develop, manufacture and commercialize these product candidates as part of our long-term revenue growth.

Our Technical Capabilities

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● Injectable.

Our injectable product technologies enable us to develop and manufacture generic and proprietary injectables in liquid, lyophilized, suspension, and emulsion forms, as well as the use of pre-filled syringes to facilitate safety and convenience to users.

Our injectable product technologies enable us to develop and manufacture generic and proprietary injectables in liquid, lyophilized, suspension, and emulsion forms, as well as the use of prefilled pens and prefilled syringes to facilitate safety and convenience to users.

We have multiple injectable manufacturing facilities that include aseptic filling lines dedicated to the sterile production of injectable products.

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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 that can be used to load our products into various inhalation devices.

We have expertise in formulating HFA-based MDIs, 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.

Additionally, we have extensive formulation and clinical experience in developing complex formulations that can be administered by intranasal delivery.

In addition, we are developing formulations using a new environmentally friendly propellant for use in future MDI products as part of our ongoing efforts to advance inhalation technologies.

We have advanced capabilities that enable us to develop technically challenging products.

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Unwanted immunogenicity, which is strongly linked with peptide and protein drug products, occurs when a patient mounts an undesired immune response against drug therapy.

As a result, the FDA has signaled that they may require immunogenicity studies as part of the new pathway for biosimilars and biogenerics.

As a result, the FDA has signaled that it may require immunogenicity studies as part of the new pathway for biosimilars.

In the past, the FDA has required these studies to approve products with complex molecules.

We have gained expertise in immunogenicity by performing immunogenicity studies in connection with the FDA approval process for our enoxaparin product.

We believe that our experience conducting these complex immunogenicity studies will be of primary importance in our future efforts to develop complex molecules, biosimilar, and biogeneric product candidates.

We have gained expertise in

immunogenicity by performing immunogenicity studies in connection with the FDA approval process for our enoxaparin product.

We believe that our experience conducting these complex immunogenicity studies will be of primary importance in our future efforts to develop complex molecules, and biosimilar product candidates.

● Peptide and protein product development and production.

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We currently manufacture and sell over 25 products.

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

The following is a description of major and recently launched products in our existing portfolio.

BAQSIMI ® (glucagon) nasal powder 3mg

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We received the first-ever FDA approval of a generic version of rDNA Glucagon in the fourth quarter of 2020.

Using a dedicated process and sophisticated characterization technology, we demonstrated to the FDA that our highly purified synthetic peptide product is bioequivalent and therapeutically equivalent to the reference listed drug, or RLD, which is an rDNA product.

Using a dedicated process and sophisticated characterization technology, we demonstrated to the FDA that our highly purified synthetic peptide product is

bioequivalent and therapeutically equivalent to the reference listed drug, or RLD, which is an rDNA product.

Glucagon for injection emergency kit is indicated for the treatment of severe hypoglycemia and is used as a diagnostic aid.

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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.

We also sell REXTOVY ® , 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

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● Our portfolio of emergency syringe products, including critical care drugs such as atropine, calcium chloride, dextrose, epinephrine, lidocaine, and sodium bicarbonate, are provided in pre-filled syringes and are designed for emergency use in hospital settings;

● Morphine injection in prefilled syringe, pain management product indicated for use with Patient Controlled Analgesia (PCA) pumps;

● Lorazepam injection, a sedative used prior to surgery and medical procedures;

● 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 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, 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.

● Iron sucrose injection, an iron replacement product indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease;

● Teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen.

is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO ® , for managing daily osteoporosis therapy;

● Ipratropium Bromide HFA inhalation aerosol is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

We manufacture and sell two API products:

Recombinant Human Insulin, or RHI API, and porcine insulin API.

These products are part of our vertical integration strategy, as we focus on specific finished products for the injectable insulin market.

We also sell RHI API and porcine insulin API to third parties.

Additionally, we plan to sell two GLP-1 APIs which were developed and manufactured at our ANP facility to third parties.

Sales of small batches for R&D purposes has already begun, but more meaningful sales will require a regulatory approval outside of the U.S.

Our Product Candidates

We seek to develop product candidates with high technical barriers to competitive market entry that leverage our technical capabilities and other competitive advantages.

We focus on generic and proprietary product candidates in the injectable, inhalable and intranasal markets.

We focus on generic and proprietary product candidates in the injectable, inhalable, topical, and intranasal markets.

Our pipeline products are in various stages of development, with a number of these candidates still in the early stages of development.

Our pipeline has over 10 product candidates, including generic ANDAs, biosimilar, and proprietary product candidates.

The following table includes several of our technical capabilities needed for the generic ANDAs, biosimilar product candidates and proprietary products in development.

Characterization

Immunogenicity

Sustained-Release

The development, regulatory approval for and commercialization of our product candidates are subject to numerous risks.

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● injectable technologies, which include various delivery methods and sizes of pre-filled syringes, vials in solution, suspension and lyophilized forms;

● inhalation technologies, which include MDIs and DPIs;

● inhalation technologies, which include MDIs;

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

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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).

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

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

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.

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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

Intranasal epinephrine (AMP-019)

Intranasal epinephrine, a prescription epinephrine nasal spray product candidate, is intended to be used for emergency treatment of allergic reactions, including anaphylaxis to stinging insects, allergen immunotherapy, foods, drugs and other allergens.

AMP-105 is a first-in-class peptide targeting a novel mechanism to modulate cell growth and metastasis of multiple poorly treated cancers, offering a new anti-tumor option for patients.

AMP-107 is the first non-injectable anti-vascular endothelial growth factor receptor peptide, which is developed as a topical eye drop for the treatment of wet age-related macular degeneration.

It is intended to be an alternative to the routine eye injections used for current treatments.

AMP-109 is a novel peptide-docetaxel conjugate that targets a specific receptor, designed to improve the selectivity and bioavailability of docetaxel.

It is designed to reduce docetaxel-induced toxicity, which will improve the efficacy and safety of current taxane therapies.

AMP-110 is a novel synthetic human corticotropin (ACTH) analog.

This peptide will target multiple indications.

Other Proprietary Product Candidates

In addition to intranasal epinephrine, we have three other proprietary product candidates in development.

In addition, we have other proprietary product candidates in development.

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

BAQSIMI ® Acquisition

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.

As of January 1, 2025, the transition pursuant to 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.

For more information see “Part II – Item 8.

Financial Statements and Supplementary Data – Notes to Consolidated Financial Statements – Note 3.

BAQSIMI ® Acquisition.”

Research and Development

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and Nanjing, China.

We own or lease a total of 68 buildings at six locations in the United States, France and China, that comprise 2.4 million square feet of manufacturing, research and development, distribution, packaging, laboratory, office and warehouse space.

As of December 31, 2025, we own or lease a total of 69 buildings at six locations in the United States, France and China, that comprise 2.5 million square feet of manufacturing, research and development, distribution, packaging, laboratory, office and warehouse space.

Our facilities are regularly inspected by the FDA in connection with our product approvals, and we believe that all of our facilities are being operated in material compliance with the FDA’s cGMP regulations.

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

However, we are planning to increase capacity at our plant in Rancho Cucamonga, CA which will allow us to eventually quadruple the number of units produced at this facility.

However, we are planning to increase capacity at our plant in Rancho Cucamonga, CA with the goal of allowing us to eventually quadruple the number of units produced at this facility.

We are also increasing the capacity of our inhalation facility in Canton, MA and our insulin API production facility at ANP.

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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 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.

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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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% of Net Revenues

McKesson Corporation

Cardinal Health, Inc.

Cardinal Health

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 ® and Primatene MIST ® with healthcare professionals.

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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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(3) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration;

or (4) the patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the ANDA is submitted.

or (4) the patent is invalid or will not be

infringed upon by the manufacture, use or sale of the drug product for which the ANDA is submitted.

This last certification is known as a Paragraph IV certification.

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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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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 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.

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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Broadly, this exclusivity applies when the ANDA applicant is considered as the first approved applicant, and there is no other exclusivity period eligibility.

Many of our ANDAs on file and many of the products that we are developing qualify for CGT.

Many of the products that we are developing qualify for CGT.

Having a generic product designated as CGT provides for certain actions which the FDA may take in order to expedite the development and review of an ANDA.

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Before human clinical trials can begin on a new drug, the results of preclinical tests, together with manufacturing information and analytical data, must be submitted to the FDA as part of an IND and the FDA must permit the IND to become effective.

Each clinical trial under an IND must be reviewed and approved by an independent Institutional Review Board, or IRB.

Each clinical trial under an IND must be reviewed and approved by an independent Institutional

Review Board, or IRB.

Human clinical trials are typically conducted in three sequential phases that may overlap.

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An applicant with a pending or approved biosimilar application may seek an FDA determination that its product is interchangeable with the reference drug.

In addition to demonstrating biosimilarity to the reference product, the biosimilar applicant must demonstrate that its product can be expected to yield the same clinical result as the reference product in any given patient.

In addition to demonstrating biosimilarity to the reference product, the

biosimilar applicant must demonstrate that its product can be expected to yield the same clinical result as the reference product in any given patient.

If the biosimilar product may be administered more than once to a patient, the applicant must demonstrate that the risk in terms of safety or diminished efficacy of alternating or switching between the biosimilar and reference products is not greater than the risk of continued administration of the reference product.

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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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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.

● 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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Success in early stage clinical trials does not assure success in later stage clinical trials.

Data obtained from clinical activities are not always conclusive and may be subject to varying interpretations that could delay, limit or prevent regulatory approval.

obtained from clinical activities are not always conclusive and may be subject to varying interpretations that could delay, limit or prevent regulatory approval.

Even if a product receives regulatory approval, later discovery of previously unknown problems with a product may result in restrictions on the product or complete withdrawal of the product from the market.

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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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The FDA has authority to inspect manufacturing facilities as well as other facilities in which drug products are held, packaged or stored, to determine compliance with cGMP and other requirements under the FDCA.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to

have improperly promoted off-label uses may be subject to significant liability.

In addition, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.

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In addition, various states have enacted false claims laws analogous to the FCA, and many of these state laws apply where a claim is submitted to any third-party payer and not merely a federal or other governmental health care program.

When an entity is determined to have violated the FCA, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties of between $13,946 and $27,894 for each separate instance of a false claim, subject to adjustment for inflation.

When an entity is determined to have violated the FCA, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties of up to $25,595 under 42 CFR 1003.210(a)(1) for each violation, subject to adjustment for inflation.

There are many potential bases for liability under the FCA.

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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.

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.

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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.

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).

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.

Additionally, there are criminal penalties if an entity intentionally makes false statements in such reports.

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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.

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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The costs of complying with various applicable environmental requirements, as they now exist or as may be altered in the future, could adversely affect our financial condition and results of operations.

For example, as a result of environmental concerns about the use of CFCs, the FDA issued a final rule on January 16, 2009 that required the phase-out of the CFC version of our Primatene MIST ® product by December 31, 2011.

This phase out caused us to halt sales of the CFC version of our Primatene MIST ® product subsequent to December 31, 2011 and write off our inventory for the product, which had an adverse effect on our financial results.

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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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.

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

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.

Coverage and Reimbursement

Sales of our products will depend, in part, on the extent to which our products will be covered by third-party payers, such as government health programs, commercial insurance, and managed healthcare organizations.

In the U.S., for example, principal decisions about government reimbursement for new products are typically made by CMS, the agency that administers the Medicare program through regional contractors, state Medicaid programs, third-party payers, and insurance plans for certain patient populations.

These entities decide whether and to what extent a new product will be covered and reimbursed based on clinical needs and economic impact.

To date, no uniform policy of coverage and reimbursement for drug products exists.

Accordingly, decisions regarding the extent of coverage and amount of reimbursement to be provided for any of our products will be made on a payer-by-payer basis.

Increasingly, third-party payers are requiring that drug companies provide them with discounts usually in the form of rebates from list prices and are challenging the prices charged for medical products.

Further, such payers are examining the medical necessity and reviewing the cost effectiveness of newly launched drugs.

There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs.

Third-party payers may limit coverage to specific product candidates on an approved list, known as a formulary, which might not include all FDA-approved drugs for a particular indication.

We may need to conduct additional expensive pharmaco-economic Phase 4 real-world studies to demonstrate the medical necessity and cost effectiveness of our products.

As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products, with no assurance that coverage and adequate reimbursement will be obtained.

Additionally, maintaining coverage for a product is often evaluated annually by payers and additional barriers may be placed impacting access.

We are committed to partnering with payers to ensure broad access and affordability.

Pharmaceutical Pricing

We participate in the Medicaid Drug Rebate Program and Medicare Part D Coverage Gap Discounts Program, or Medicare Part D.

Participation is required for federal funds to be available for our covered outpatient drugs under Medicaid and Medicare Part B, or Medicare Part B, and under Medicare Part D, respectively.

Under the Medicaid Drug Rebate Program, we are required to pay a mandatory rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available to the states for our drugs under Medicaid.

Those rebates are based on pricing data reported by the manufacturer on a monthly and quarterly basis to CMS.

These data include the average manufacturer price and, in the case of innovator products, the best price for each drug, which, in general, represents the lowest price available from the manufacturer to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity in the U.S.

in any pricing structure, calculated to include all sales and associated rebates, discounts, and other price concessions.

Under the Medicare Part D Coverage Gap Discount Program, manufacturers, including us, are currently required to provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Medicare Part D benefit design.

The IRA sunsets the coverage gap discount program starting in 2025 and replaces it with a new manufacturer discount program.

The Affordable Care Act, or ACA, made significant changes to the Medicaid Drug Rebate Program, and CMS issued a final regulation to implement the changes to the Medicaid Drug Rebate Program under the ACA.

CMS also issued a final regulation that modified prior Medicaid Drug Rebate Program regulations to permit reporting multiple best price figures with regard to value-based purchasing arrangements;

and provide definitions for “line extension,” “new formulation,” and related terms, with the practical effect of expanding the scope of drugs considered to be line extensions that are subject to an alternative rebate formula.

Federal law requires that any company that participates in the Medicaid Drug Rebate Program also participate in the Public Health Service’s 340B drug pricing program in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B.

The 340B drug pricing program requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B ceiling price for the manufacturer’s covered outpatient drugs.

These 340B covered entities include a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients.

The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate Program.

Further, the Inflation Reduction Act, or IRA, of 2022 established a Medicare Part D inflation rebate schemes and a drug price negotiation program, with the first negotiated prices to take effect in 2026.

It also makes several changes to the Medicare Part D benefit, including the creation of a new manufacturer discount program in place of the current coverage gap discount program that began in 2025.

Under IRA, only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year.

For 2026, CMS selected 10 high-cost Medicare Part D drugs.

CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027.

For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected.

Various industry stakeholders have initiated lawsuits against the federal government asserting that the price negotiation provisions of the IRA are unconstitutional.

the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of HHS to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S.

Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the U.S.

In November 2025, CMS announced a voluntary initiative called the GENEROUS Model (GENErating cost Reductions fOr U.S.

Medicaid Model) to introduce the option of most-favored-nation pricing to the Medicaid program, whereby a drug manufacturer may voluntarily offer supplemental rebates to participating state Medicaid programs for a manufacturer’s covered outpatient drugs.

Government agreements with pharmaceutical companies and other measures that use most-favored-nation pricing targets for prescription drugs or that increase generic and biosimilar drug entry sooner than expected can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future, or the pricing of our approved product in the U.S.

and in foreign countries.

In addition, to be eligible to have its products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, a manufacturer also must participate in the U.S.

Department of Veterans Affairs, or VA, Federal Supply Schedule, or FSS, pricing program.

Under this program, the manufacturer is obligated to make its innovator and single source products available for procurement on an FSS contract and charge a price to four federal agencies, the VA, U.S.

Department of Defense, or DoD, Public Health Service and U.S.

Coast Guard - that is no higher than the statutory Federal Ceiling Price, or FCP.

Manufacturers also are obligated to calculate and submit to the VA on a quarterly and annual basis, their Non-Federal Average Manufacturer Price, or Non-FAMP, which the VA uses to calculate the FCP.

Moreover, pursuant to regulations issued by the DoD Defense Health Agency to implement Section 703 of the National Defense Authorization Act for Fiscal Year 2008, manufacturers are required to provide rebates on utilization of their innovator and single source products that are dispensed to TRICARE beneficiaries by TRICARE network retail pharmacies.

The requirements under the Medicaid, 340B, FSS, and TRICARE programs could reduce the revenue we may generate from any products that are commercialized in the future and could adversely affect our business and operating results.

If we fail to comply with any applicable obligations under governmental pricing programs that we participate in, we could be subject to additional reimbursement requirements, significant civil monetary penalties, sanctions and fines, and those could negatively impact our business, financial condition, results of operations and growth prospects.

In addition, in most foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.

The requirements governing drug pricing and reimbursement vary widely from country to country.

For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.

A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.

Pharmaceutical products may face competition from lower-priced products in foreign countries that have placed price controls on pharmaceutical products and may also compete with imported foreign products.

There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing.

Healthcare Reform

government, state legislatures, and foreign governments have shown significant interest in implementing cost containment programs to limit the growth of government-paid healthcare costs, including price-controls, restrictions on reimbursement, and requirements for substitution of generic products and/or lower cost over the counter alternatives for branded prescription drugs.

For example, the ACA substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S.

pharmaceutical industry.

The ACA contains provisions that may reduce the profitability of drug products through increased rebates for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal health care programs.

The ACA made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers’ rebate liability by raising the minimum basic Medicaid rebate.

The ACA also expanded the universe of Medicaid utilization subject to drug rebates by requiring pharmaceutical manufacturers to pay rebates on Medicaid managed care utilization and by enlarging the population potentially eligible for Medicaid drug benefits.

There have been judicial challenges to certain aspects of the ACA, as well as efforts by Congress to modify, and by agencies to alter the implementation of, certain aspects of the ACA.

For example, Congress eliminated the tax penalty for not complying with the ACA’s individual mandate to carry health insurance.

Further, the Bipartisan Budget Act of 2018, among other things, amended the ACA to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D to close the coverage gap in most Medicare drug plans, commonly referred to as the "donut hole." In 2025, the IRA sunsets the coverage gap discount program and replaces it with a new manufacturer discount.

It is possible that the ACA, as currently enacted or may be amended in the future, as well as other healthcare reform measures including those that may be adopted in the future, may result in more rigorous coverage criteria, and less favorable payment methodologies, or other downward pressure on coverage and payment and the price that we receive for any approved product.

Any reduction in reimbursement or restriction on coverage under Medicare or other government programs may result in a similar reduction or restriction by private payers.

Other legislative changes have been proposed and adopted in the U.S.

since the ACA was enacted.

These changes included aggregate reductions to Medicare payments to providers of 2% per fiscal year required by the Budget Control Act of 2021, as amended by the American Taxpayer Relief Act of 2012, or ATRA.

Subsequent legislation extended the 2% reduction, generally to FY 2032.

ATRA, among other things, also reduced Medicare payments to several types of providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Other new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs, if approved, and accordingly, our financial operations.

Moreover, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or MMA, established the Medicare Part D program to provide a voluntary prescription drug benefit to Medicare beneficiaries.

Under Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities that provide coverage of outpatient prescription drugs.

Unlike Medicare Part A and B, Part D coverage is not standardized.

While all Medicare drug plans must give at least a standard level of coverage set by Medicare, Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level.

However, Part D prescription drug formularies must include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the drugs in each category or class.

Any formulary used by a Part D prescription drug plan must be developed and reviewed by a pharmacy and therapeutic committee.

Government payment for some of the costs of prescription drugs may increase demand for products for which we receive marketing approval.

However, any negotiated prices for our products covered by a Part D prescription drug plan likely will be lower than the prices we might otherwise obtain.

Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private third-party payers often follow Medicare coverage policy and payment limitations in setting their own payment rates and in establishing their formulary placement.

Further, the IRA introduces several changes to the Medicare Part D benefit, including a limit on annual out-of-pocket costs and a change in manufacturer liability under the program which could negatively affect the profitability of our product candidates.

The IRA sunsets the current Part D coverage gap discount program starting in 2025 and replaces it with a new manufacturer discount program.

Failure to pay a discount under this new program will be subject to a civil monetary penalty.

In addition, the IRA established a Medicare Part B inflation rebate scheme effective January 2023 and a Medicare Part D inflation rebate scheme effective October 2022, under which, generally speaking, manufacturers will owe rebates if the price of a Part B or Part D drug increases faster than the pace of inflation.

Failure to timely pay a Part B or D inflation rebate is subject to a civil monetary penalty.

The IRA also creates a drug price negotiation program under which the prices for Medicare units of certain high Medicare spend drugs and biologicals without generic or biosimilar competition will be capped by reference to, among other things, a specified non-federal average manufacturer price starting in 2026.

Failure to comply with requirements under the drug price negotiation program is subject to an excise tax and/or a civil monetary penalty.

Congress continues to examine various policy proposals that may result in pressure on the prices of prescription drugs with respect to the government health benefit programs and otherwise.

The IRA or other legislative changes could impact the market conditions for our product candidates.

The One Big Beautiful Bill Act of 2025, or the OBBB Act, includes provisions that impact the United States healthcare system in various ways, including cuts to Medicaid and introducing new participant eligibility requirements for Medicaid coverage, which are expected to significantly change the administration and applicability of Medicaid coverage.

Additionally, there has been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and

state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Finally, some states have established Prescription Drug Affordability Boards (or similar entities) to review high-cost drugs and, in some cases, set upper payment limits.

Intellectual Property

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We also own several trademarks registered with the USPTO.

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

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

Patent Number 10,213,487, 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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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, 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.

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