Amphastar Pharmaceuticals : 2026 Bank of America Health Care Conference

Published: 2026-05-12 16:51:13 ET AMPH

Published on 05/12/2026 at 04:51 pm EDT

Injectables Inhalation Intranasal

New Molecular Peptides

Proprietary

2026 Bank of America Health Care Conference

May 13th, 2026

Highly Purified Peptide/Protein

Biosimilar Interchangeable

Oncology Ophthalmology Rheumatology

Company Overview

Extensive in-house product development capabilities

Advanced technical platforms and analytical instrumentation

In-house animal studies and clinical research team

Fully Integrated manufacturing

API and key materials production

Device and component manufacturing

U.S.-based finished product manufacturing

Complete Front-End integration

Marketing

Distribution

Product Development

API / Key Components Manufacturing

US Based Finished Product Manufacturing

Marketing

A One-Stop, Vertically Integrated Model

Full control of

quality and compliance across development and manufacturing

Distribution

Year

2018 2019 2020 2021 2022 2023 2024 2025

5% 3.5%

5.5%

9.0%

10%

15%

15.5%

20%

21.8%

20.7%

25%

27.3% 27.4%

30%

35%

Adjusted Net Income Margin, %

Amphastar's management team operates the Company with a clear focus on:

High Quality for products

High Efficiency for operation and

Adjusted Net Income Margin, %

High Technology to drive pipeline development The 3-H focus results in high net income margin

($Million or Specified)

2018

2019

2020

2021

2022

2023

2024

2025

Revenue, x

295

322

350

438

499

644

732

720

Net Income (GAAP)

-5.7

48.9

1.4

62.1

91.4

137.5

159.5

98.1

Net Income, Adjusted, y

10.4

17.8

31.6

68.0

103.2

175.7

200.8

156.6

Net Income Margin, Adjusted, =y/x, %

3.5%

5.5%

9.0%

15.5%

20.7%

27.3%

27.4%

21.8%

Leveraging Strategic Vision & Core Strengths

2021 Pipeline

Proprietary 21%

Generic 63%

Biosimilar 16%

Projected 2026 Pipeline

Generic

Proprietary 50%

15%

Biosimilar 35%

Particle Engineering

Novel Formulation

Characterization

Immunogenicity Evaluation

Highly-Purified

rDNA

Peptide/Protein

Novel Device

NDA

The Only FDA approved asthma inhaler available as

OTC

Multiple peptide/protein products, including AMP-028

Insulin Analogs

BLA

Biosimilar Interchangeable

ANDA

Baqsimi®

R&D and Proprietary Pipeline

Strategic focus and emphasis on investment in R&D differentiates us from our competitors, as our focus is on the long-term growth of our company

Diverse pipeline development with flexibility and scalability for sourcing APIs, starting materials, and research within our vertically integrated platform

R&D includes API, early-stage, and clinical trials

Expect R&D spending to increase as we focus on proprietary products

$369M self-funded R&D investment over five years, fueling proprietary innovation.

Achieved branded product success & built the platform to repeat it

160+

Demonstrated ability to commercialize branded peptides globally: acquired, integrated and fully assumed global supply

BAQSIMI

R&D employees

Decade-long proprietary development from lab to OTC market: complex HFA inhalation formulation requiring novel particle engineering and clinical validation, built entirely in-house

PRIMATENE MIST

2.4M

Preclinical through Phase 3 in-house development expertise: dedicated clinical team handling study design, statistical analysis and regulatory submissions

Clinical Depth

Sq. ft. of global facilities

Growing potential best-in-class peptide pipeline with differentiated mechanisms in high growth therapeutic areas (oncology, ophthalmology & autoimmune): AMP-105, AMP-107, AMP-109, AMP-110

Peptide Pipeline

25+

Commercial products

Accelerating infrastructure investment: facility expansions, all U.S. finished products manufactured domestically and built for branded-product-grade compliance

Infrastructure

Three interchangeable insulin biosimilars in development: AMP-004 (Insulin Aspart), AMP-005 (Recombinant Human Insulin), AMP-028

Biosimilar Path

10+

Pipeline candidates

Fully integrated U.S.-based R&D and manufacturing platform: advancing complex generics, biosimilar insulins and proprietary peptides toward long-term pipeline leadership

Program(s)

Potential Indication(s)

2026

2027

2028

AMP-101

Intranasal Epinephrine

Anaphylaxis

Phase 1 Study

Phase 2/3 Stud

y NDA

AMP-105

First-in-class peptide with potential novel mechanism of action

HNSCC, HCC, Lymphoma, Multiple Myeloma, and other solid tumors

Preclinical: IN

D-Enabling

IND-Filing

AMP-107

Non-invasive eye drop alternative to injected anti-VEGF therapies

wet-AMD, DME

Preclinical: IND-Enabling

IND-Filing

Phase 1 Study

AMP-109

Peptide-coupled docetaxel

Pancreatic, Esophageal, Gastric Cancers, Colorectal, NSCLC, and other solid tumors

Preclinical: IND-Enabling

IND-Filing

Phase 1 Study

AMP-110

Synthetic human

Acute MS/RA exacerbations, gouty arthritis flares, ocular inflammation, etc.

Preclinical: IND-Enabling

IND-Filing

Phase 1 Study

corticotropin (ACTH)

analog

AMP-105

HNSCC, HCC,

Lymphoma, Multiple Myeloma, and other solid tumors

Potential novel MoA targeting cell growth and metastasis inhibition

Early studies show broad

anti-tumor activity

~60k solid tumor patients

First-in-class peptide with a novel mechanism offering a new therapeutic option for multiple cancer types

Non-invasive eye drop

alternative to injected anti-VEGF therapies

~125k lymphoma & myeloma patients

AMP-107

wet-AMD, DME

First non-injectable anti-VEGFR eye drop

Targets VEGFR and

integrin αvβ3

Oncology Ophthalmology Rheumatology

Aims to reduce treatment burden and improve compliance

2.2 - 3.4 Mn

wet-AMD & DME patients

$9.4Bn 2024 net revenue for anti-VEGF injections

Source: 1) IQVIA National Sales Perspective Database, 2) SEER 2025, 3) 2025 Company Reports, 4) Secondary Epidemiology Research, 5) IQVIA Research and Analysis 13

CRC: Colorectal Cancer; DME: Diabetic Macular Edema; HCC: Hepatocellular Carcinoma; HNSCC: Head & Neck Squamous Cell Cancer; MM: Multiple Myeloma; NSCLC: Non-Small Cell Lung Cancer; wet-AMD: wet-Age-Related Macular Degeneration; MS: Multiple

Sclerosis; RA: Rheumatoid Arthritis

AMP-109

Pancreatic, Esophageal, Gastric Cancers, Colorectal, NSCLC, and other solid tumors

Peptide-coupled docetaxel with improved bioavailability and Efficacy

Improved safety profile

Reduced Docetaxel-induced Toxicity

~91 - 125k NSCLC

Improved safety and efficacy profile for taxane-based chemotherapy

Fully synthetic, highly purified peptide with differentiated safety profile (significantly lower impurity levels, reduced immunogenicity and viral transmission risks compared to porcine-sourced ACTH)

patients

~101 - 121k GI

cancer patients

AMP-110

Acute MS/RA exacerbations, gouty arthritis flares, ocular inflammation, etc.

A novel synthetic human corticotropin (ACTH) analog with 97% amino acid sequence homology to endogenous human ACTH

Improved safety profile

Oncology Ophthalmology Rheumatology

Phase I clinical development stage

~25% TRx

Rheumatology indications

~15% - 20% TRx

Ophthalmology indications

Established U.S. market for penetration

U.S. addressable ACTH market size of over $684 million and growing

Source: 1) IQVIA National Sales Perspective Database, 2) SEER 2025, 3) 2025 Company Reports, 4) Secondary Epidemiology Research, 5) IQVIA Research and Analysis

P Value

6 h

24 h

48 h

Healthy vs Model

<0.0001

Model vs ACTH (Porcine)

0.7960

0.0102

<0.0001

Model vs AMP-110-Low

0.0703

0.0221

<0.0001

Model vs AMP-110-High

0.0271

<0.0001

Generic and Biosimilar Pipeline

ANDA Type

Product Code

Current Stage

IQVIA Sales*

Injectable

AMP-015 (Teriparatide)

Launched in December 2025

+$500 Million

AMP-018 (GLP-1)

Commercial launch expected in 2027

+$300 Million

AMP-029

Development

+$500 Million**

Inhalation

AMP-007 (Ipratropium Bromide)

Launched April 2026

+100 Million

AMP-017

Planned Filing 1H 2027

+1.2 Billion

AMP-023

Development

Biosimilar

AMP-004 (Insulin Aspart)

Commercial launch expected in 2027

$1.4 Billion

AMP-005 (Recombinant Human Insulin)

Planned filing 1H 2027

$0.2 Billion

AMP-028

Development

$2.5 Billion

*IQVIA sales TTM as of March 31, 2026

** As reported by Brand Company

Interchangeable Insulin Pipeline

AMP-004

AMP-005

Recombinant

Human Insulin

Insulin

Aspart

Glucagon Inj. Kit

AMP-018

BAQSIMI® Nasal

Powder

GLP-1

ANDA

BAQSIMI®, the first and only FDA approved glucagon nasal powder

The first FDA approved generic Glucagon injection kit

Insulin Pipeline:

- $1.7 Billion in IQVIA sales*

*IQVIA sales TTM as of March 31, 2026

Sales and Marketing

Disclaimer

Amphastar Pharmaceuticals Inc. published this content on May 12, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 12, 2026 at 20:50 UTC.