Reimagining Molecules to Advance Medicine - Corporate Presentation - September 2021
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Reimagining Molecules to Advance Medicine Corporate Presentation – September 2021 ©2021 Eton Pharmaceuticals. All rights reserved. 1
Safe Harbor
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This document contains forward-looking statements concerning Eton Pharmaceuticals, Inc. (“Eton”, the “Company,” “we,” “us,” and “our”). The words “believe,” “may,” “will,”
“potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and similar expressions that convey uncertainty of future events or outcomes are
intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the following:
• our future financial and operating results;
• our intentions, expectations and beliefs regarding anticipated growth, market penetration and trends in our business;
• the timing and success of our plan of commercialization;
• our ability to successfully develop and clinically test our product candidates; and
• our ability to file for FDA approval of our product candidates through the 505(b)(2) regulatory pathway.
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk Factors” section of the Registration Statement
on Form S-1 filed Eton with the Securities and Exchange Commission on September 25, 2018. In light of these risks, uncertainties and assumptions, the forward-looking events and
circumstances discussed in this document may not occur and actual results could differ materially and adversely from those anticipated or implied in our forward-looking
statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in our forward-looking
statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will
be achieved or occur.
This document contains only basic information concerning Eton. Because it is a summary it does not contain all of the information you should consider before investing.
Before you invest, you should read the prospectus in that registration statement and other documents Eton has filed with the SEC for more complete information about Eton and this
offering. You may get these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov. Alternatively, Eton, any underwriter or any dealer participating in the offering
will arrange to send you the prospectus if you request it by calling National Securities Corporation toll-free at 1-800-832-6084.
Disclaimer: Products discussed in this presentation are under development and not yet approved by the FDA. The information presented here is to the best of the company's current
knowledge and assumptions, which may be different from the labeling and conditions provided by the FDA upon approval, which approval itself is not guaranteed. In no event should
this information be construed as marketing or promotion, or providing directions for use of any product, all of which are contingent on FDA approval.
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©2021 Eton Pharmaceuticals. All rights reserved.
Eton Pharmaceuticals
Innovative pharmaceutical firm focused on developing and
commercializing orphan drug products
Development and regulatory Track record of successfully Profit focused company
expertise - 9 product executing value-creating - expected to reach
submissions and 4 approvals business development consistent profitability
since company founding in 2017 transactions in 2022
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©2021 Eton Pharmaceuticals. All rights reserved.
Company Overview
• Major inflection point with transition from development stage to commercial company in 2021
- ALKINDI® SPRINKLE launched in late Q4 2020
- Alaway® Preservative Free launched in February 2021
- Rezipres ® launch planned for late 2021
• Diversified and growing revenue sources
- Eton commercializes ALKINDI SPRINKLE in the United States
- Receives royalties or profit shares from two commercial products (Alaway Preservative Free & Biorphen)
- Eton expects to receive up to $30 million of additional milestones plus royalties from out-license of Eton’s neurology
oral liquid products
• Five new products expected to launch within twelve months
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©2021 Eton Pharmaceuticals. All rights reserved.
Portfolio
Eton’s portfolio includes two categories of products:
Orphan Drug Products Royalty Products
Orphan designated products that are typically promoted by Products promoted by partners or which do not require any
Eton to treat unmet needs in rare diseases promotional investment. Eton typically receives royalties or
profit share payments
Product Indication Status Product Indication Status
ALKINDI SPRINKLE® (USA) Adrenal Insufficiency Commercial Biorphen® Hypotension Commercial
Dehydrated Alcohol Injection Methanol Poisoning Filed Alaway® Preservative Free Allergic Conjunctivitis Commercial
ALKINDI SPRINKLE® (Canada) Adrenal Insufficiency Pre-Filing Rezipres® (RTU ephedrine inj) Hypotension Approved
ZENEO® Hydrocortisone Adrenal Crisis Pre-Filing Zonisamide Oral Susp Epilepsy Filed
Topiramate Oral Soln Epilepsy / Migraine Filed
Lamotrigine for Susp Epilepsy Filed
Cysteine Injection Parenteral Nutrition Filed
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©2021 Eton Pharmaceuticals. All rights reserved.
Orphan Drug Products Strategy
• Develop and commercialize products that treat unmet needs in rare diseases
• Product characteristics targeted:
- Late-stage products (filed or can be filed within ~12 months)
- Products with small prescriber bases that can be reached with targeted sales forces
(i.e. less than 1,000 pediatric endocrinologists in the U.S.)
- Significant unmet need – avoiding crowded or competitive indications
- Known molecules with existing safety and efficacy data (literature, use in foreign countries,
historic usage, etc.)
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©2021 Eton Pharmaceuticals. All rights reserved.
Royalty Products Strategy
• Eton leverages its expertise in product selection, business development, product development, and regulatory to create a
diversified portfolio of long-term royalty/profit share interests in innovative products
• Eton initiates development of or acquires early-stage product candidates, advances them through development, and out-
licenses to marketing partners after significant value has been created
• Commercialization does not require any additional investment from Eton and produces high-margin royalty income
Monetized Assets
Additional Investment
Eton Licensing / Total Eton
Product (development, clinical, Sale Terms Amount Received To Date
Acquisition Costs Investment
regulatory fees, etc.)
Neurology Oral Liquid Up to $45MM + Single Digit Royalty on
$2.7 $4.9 $7.6 $12.0
Portfolio (3 Products) Sales
Alaway® Preservative Free $1.0 $1.6 $2.6 $2.0MM + 12% Royalty on Sales $2.1
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©2021 Eton Pharmaceuticals. All rights reserved.Commercial Products
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©2021 Eton Pharmaceuticals. All rights reserved.ALKINDI® SPRINKLE
ALKINDI® SPRINKLE is a proprietary formulation of hydrocortisone sprinkles that is FDA approved as a
replacement therapy for adrenocortical insufficiency (AI) in patients under 17 years of age
• High-value ultra-orphan product with strong intellectual property protection.
Three orange-book listed patents extending to 2034
• Critical unmet need. Prior to ALKINDI SPRINKLE, no FDA-approved product
allowed for proper dosing of hydrocortisone for pediatric patients requiring
less than 5mg
• $100+ million market opportunity. An estimated 10,000 pediatric patients
suffer from adrenal insufficiency
• Efficient commercialization. Eton’s small sales force can effectively cover
the approximately 900 pediatric endocrinologist prescribers in the U.S.
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©2021 Eton Pharmaceuticals. All rights reserved.Alaway® Preservative Free
Alaway Preservative Free is the first and only
preservative free ophthalmic treatment FDA-approved
for allergic conjunctivitis and available over-the-counter
• Product was launched in major retailers by Bausch Health in
February 2021
• U.S. allergic conjunctivitis market is >$600 million annually
• Bausch acquired product from Eton in 2019 in exchange for
milestone payments and a royalty
• Eton receives a 12% royalty on product sales
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©2021 Eton Pharmaceuticals. All rights reserved.Biorphen®
Biorphen is the first and only FDA-approved
ready-to-use formulation of injectable phenylephrine
• Product is currently promoted by Xellia Pharmaceuticals’
hospital sales force
• U.S. market is estimated to be >20 million ready-to-use doses
annually
• Eton expects significant increase in adoption after launch of
vial (expected in 2022) and pre-filled syringe presentations
• Long-term goal for franchise to capture >4 million units
annually
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©2021 Eton Pharmaceuticals. All rights reserved.Pipeline Products
Pipeline Products
Product Indication NDA Owner Eton Category FDA Status Product Details
RTU Ephedrine • Current ephedrine RTU injectable market is >$30 million run rate and growing
Hypotension Eton Royalty Product APPROVED
Injection rapidly
Epilepsy / Filed • Expected to be first liquid formulation of topiramate
Topiramate Oral Soln Azurity Pharma Royalty Product
Migraine (November 6 PDUFA) • Current topiramate oral market is >$800MM annually
Dehydrated Alcohol Methanol • Current dehydrated alcohol inj market estimated to be >$100MM annually
Eton Orphan Product Filed
Injection Poisoning • CRL received May ‘21. Expect to submit response in 2H 2021
• Received CRL May ‘21 due to travel restrictions blocking EU facility inspection.
Zonisamide Oral Expect to be resolved in 2H 2021
Epilepsy Azurity Pharma Royalty Product Filed
Susp • Expected to be first liquid formulation of zonisamide
• Current zonisamide oral market is >$70MM annually
• Human factors study data expected to be to submitted to FDA in 2H ’21 to
address CRL
Lamotrigine for Susp Epilepsy Azurity Pharma Royalty Product Filed
• Expected to be first liquid formulation of lamotrigine
• Current lamotrigine oral market is >$700MM annually
• Confirmed first-to-file ANDA against innovator product Elcys
Parenteral
Cysteine Injection Eton Royalty Product Filed • Current market size estimated to be >$60MM annually
Nutrition
• Eton’s 30-month stay expires August 2022
ALKINDI SPRINKLE Adrenal Submission Expected in • Canada patient population estimated to be approximately 1,000 patients (~10%
Eton Orphan Product
(Canada) Insufficiency 2022 of U.S. market)
ZENEO® Submission Expected in • Needleless autoinjector under development as an emergency doses of
Adrenal Crisis Eton Orphan Product
Hydrocortisone 2023 hydrocortisone to tread adrenal crisis
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©2021 Eton Pharmaceuticals. All rights reserved.Investment Summary
• Deep product portfolio poised for sustainable long-term growth
- Three commercial products in launch stage with long runway for growth
- Five additional products expected to launch in next twelve months
• Lean operating model is expected to drive near-term profitability
- Targeted orphan product commercialization minimizes commercial costs
- Expect to earn high-margin royalty and profit share revenue
• Well-capitalized to fund internal growth and external business development
- $25.8 million of cash*
- Up to an additional $30 million of potential neurology related milestones to be received
- Began receiving Alaway® Preservative Free royalties in Q1 2021
*As of June 30, 2021
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©2021 Eton Pharmaceuticals. All rights reserved.Appendix
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©2021 Eton Pharmaceuticals. All rights reserved.Royalty Products Economics
Royalty Products
Product NDA Owner Marketing Partner FDA Status Eton Economics
Alaway Preservative Free Bausch Health Bausch Health Approved 12% of Net Sales*
Biorphen® Eton Xellia Pharmaceuticals Approved 50% of Product Profit*
Zonisamide Oral Susp Azurity Pharma Azurity Pharma Submitted
$30.0 million of regulatory milestones**
Submitted Up to $15.0 million of commercial
Topiramate Oral Soln Azurity Pharma Azurity Pharma
(November 6 PDUFA) milestones
Single Digit % of Net Sales
Lamotrigine for Susp Azurity Pharma Azurity Pharma Submitted
Rezipres® (RTU Ephedrine
Eton N/A Approved 50% of Product Profit*
Injection)
Cysteine Injection Eton N/A Submitted 62.5% of Product Profit
*Before sales commission, partner split or co-promotion expense **$12.0 million already received as of June 30, 2021
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©2021 Eton Pharmaceuticals. All rights reserved.Experienced Leadership Team
Our leadership team brings a proven track record of successfully developing and
commercializing products at industry leading companies
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©2021 Eton Pharmaceuticals. All rights reserved.©2021 Eton Pharmaceuticals. All rights reserved. 17
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