Eton Pharmaceuticals, Inc. (NASDAQ:ETON) Q4 2021 Earnings Conference Call March 16, 2022 7:00 PM ET Company Participants David Krempa - Senior Vice President, Business Development & Investor Relations Sean Brynjelsen - Chief Executive Officer Wilson Troutman – Chief Financial Officer Kevin Guthrie - Executive Vice President-Commercial Activities Conference Call Participants Mitchell Kapoor - H.C. Wainwright Justin Walsh - B. Riley Securities Operator Good evening, and welcome to the Eton Pharmaceuticals Fou ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |------------------------------------------------------------------------------------------|-----------------------------------------------------| | FOR THE TRANSITION PERIOD FROM ...

| --- | --- | --- | --- | --- | --- | |-------------------------------------------------------------------------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Reimagining Molecules to Advance Medicine Corporate Presentation – November 2021 | | | | | | | | | | | | | Safe Harbor SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This document contains forward-looking statements concerning Eton Pharmaceuticals, Inc. ("Eton", the "Com ...

Eton Pharmaceuticals (NASDAQ:ETON) Q3 2021 Earnings Conference Call November 15, 2021 4:30 PM ET Company Participants David Krempa – Senior Vice President-Business Development and Investor Relations Sean Brynjelsen – Chief Executive Officer Wilson Troutman – Chief Financial Officer Conference Call Participants Boobalan Pachaiyappan – H.C. Wainwright Operator Good afternoon and welcome to the Eton Pharmaceuticals’ Third Quarter 2021 Financial and Operating Results Conference Call. At this time, all participa ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _______________________ Commission file number: 001-38738 ETON PHARMACEUTICALS, INC. (Exact name of registrant as specified in its ch ...

Financial Data and Key Metrics Changes - Eton Pharmaceuticals reported revenue of $3.1 million for Q2 2021, which included $2.5 million of licensing revenue from a transaction with Azurity, compared to no material revenue in the prior year period [19] - General and administrative expenses increased to $3.3 million from $2.9 million year-over-year, primarily due to commercialization costs for ALKINDI SPRINKLE [20] - R&D expenses rose to $2.0 million from $1.6 million in the prior year, including a one-time $0.5 million payment for acquiring rights to ZENEO Hydrocortisone [21] - The net loss for Q2 2021 was $2.0 million, a decrease from a net loss of $4.7 million in the prior year, resulting in a loss of $0.08 per share compared to a loss of $0.23 per share previously [21] - Cash and cash equivalents at the end of Q2 2021 stood at $25.8 million, sufficient for product launches and business development opportunities [22] Business Line Data and Key Metrics Changes - The approval of Rezipres, a ready-to-use formulation of ephedrine injection, marks the fourth FDA approval for Eton, with nearly 50% of the nine products in the pipeline now approved [6][18] - ALKINDI SPRINKLE has seen growing sales, with the company planning to expand its field sales force to increase physician engagement [12][18] Market Data and Key Metrics Changes - Eton expects to launch Rezipres at a slight premium to the concentrated ephedrine injection, which sees over 6 million vials sold annually in the U.S. market [7] - The company has received favorable support from payers for ALKINDI, with over 90% of patients being reimbursed for the product [13] Company Strategy and Development Direction - Eton is focused on expanding its orphan drug pipeline and has acquired rights to ZENEO Hydrocortisone, which complements ALKINDI SPRINKLE [8][9] - The company aims to increase in-person meetings with physicians, which have proven to be more effective than virtual meetings, to drive product adoption [11][12] - Eton is optimistic about upcoming product approvals and believes it is well-positioned for strong growth in 2022 and beyond [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term outlook, citing the successful launch of ALKINDI and the upcoming launch of Rezipres [18] - The company acknowledges COVID-related challenges but remains optimistic about continuing to reach prescribing doctors face-to-face [14][25] - Management believes that the current cash position and upcoming product approvals will support growth without the need for external financing [18][22] Other Important Information - The company is preparing for the PDUFA date of November 6th for topiramate, with expectations of no inspection issues during the review [15] - Eton is addressing CRLs (Complete Response Letters) and is working to minimize future occurrences through enhanced oversight and consultation [32][33] Q&A Session Summary Question: Concerns about ALKINDI labeling and FDA involvement - Management acknowledged awareness of the issue and clarified that it was an inadvertent error regarding a Google ad, which has since been corrected [23] Question: Sales modeling for ALKINDI amid Delta variant concerns - Management believes that the population's resistance to the Delta variant will allow continued face-to-face interactions with physicians, indicating a strong growth potential for ALKINDI [24][25] Question: Product revenue breakout and expectations for Rezipres - Management did not provide specific product revenue breakdowns but indicated that ALKINDI will be the primary revenue driver moving forward [27] Question: Competition for ZENEO auto-injector - Management noted that Antares Pharma announced a competing product, but they believe there is enough market space for both products [29][30] Question: Future regulatory milestone payments from Azurity - Management expects the topiramate milestone payment to occur in 2021, with other payments likely in early 2022 [38] Question: Review period for dehydrated alcohol injection application amendment - Management anticipates a three-month review period for the amendment, assuming it is classified as minor [40] Question: Confidence in litigation regarding Cysteine injection - Management expressed strong confidence in their position, citing long-term production of the product and the immorality of opposing claims [42]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _______________________ Commission file number: 001-38738 ETON PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _______________________ Commission file number: 001-38738 ETON PHARMACEUTICALS, INC. (Exact name of registrant as specified in its ch ...

Eton Pharmaceuticals, Inc. (NASDAQ:ETON) Q4 2020 Earnings Conference Call March 16, 2021 4:30 PM ET Company Participants David Krempa - Vice President, Business Development Sean Brynjelsen - Chief Executive Officer Wilson Troutman - Chief Financial Officer Paul Stickler - Senior Vice President, Sales and Marketing Conference Call Participants Andrew D’silva - B. Riley Securities Ram Selvaraju - H.C. Wainwright Operator Good afternoon and welcome to the Eton Pharmaceuticals Fourth Quarter 2020 Financial and ...

```markdown [Cover Page and Preliminary Information](index=1&type=section&id=Cover%20Page) [Form 10-K Filing Details](index=1&type=section&id=Form%2010-K%20Filing%20Details) This document is an Annual Report on Form 10-K for Eton Pharmaceuticals, Inc., covering the fiscal year ended December 31, 2020, filed with the Securities and Exchange Commission - This is an Annual Report on Form 10-K for the **fiscal year ended December 31, 2020**[3](index=3&type=chunk) - The registrant is ETON PHARMACEUTICALS, INC., incorporated in Delaware[3](index=3&type=chunk) [Registrant Information](index=1&type=section&id=Registrant%20Information) Eton Pharmaceuticals, Inc. is a Delaware corporation with its common stock trading on The Nasdaq Global Market under the symbol ETON - Eton Pharmaceuticals, Inc. is a Delaware corporation[3](index=3&type=chunk) - Its common stock trades on The Nasdaq Global Market under the symbol ETON[2](index=2&type=chunk) - The registrant's telephone number is **(847) 787-7361**[3](index=3&type=chunk) [Filer Status and Market Value](index=1&type=section&id=Filer%20Status%20and%20Market%20Value) Eton Pharmaceuticals is classified as a non-accelerated filer, a smaller reporting company, and an emerging growth company. As of June 30, 2020, the aggregate market value of common stock held by non-affiliates was approximately $64.2 million, with 24,407,616 shares outstanding as of March 8, 2021 - Eton Pharmaceuticals is a **non-accelerated filer**, a **smaller reporting company**, and an **emerging growth company**[6](index=6&type=chunk) - The aggregate market value of common stock held by non-affiliates was **approximately $64.2 million as of June 30, 2020**[6](index=6&type=chunk) - As of **March 8, 2021**, there were **24,407,616 shares of common stock outstanding**[7](index=7&type=chunk) [Documents Incorporated by Reference](index=2&type=section&id=Documents%20Incorporated%20by%20Reference) Portions of the registrant's definitive proxy statement for its 2021 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K - Portions of the registrant's definitive proxy statement for its **2021 Annual Meeting of Stockholders** are incorporated by reference into **Part III** of this Annual Report on Form 10-K[9](index=9&type=chunk) [Note Regarding Forward-Looking Statements](index=4&type=section&id=Note%20Regarding%20Forward-Looking%20Statements) [Nature of Forward-Looking Statements](index=4&type=section&id=Nature%20of%20Forward-Looking%20Statements) This report contains forward-looking statements that involve risks and uncertainties, based on management's good faith judgment and current known facts, but actual results may differ materially - The Annual Report contains forward-looking statements based on management's good faith judgment and currently known facts[15](index=15&type=chunk) - These statements are inherently subject to risks and uncertainties, and actual results may differ materially from those discussed[15](index=15&type=chunk) - Examples include statements regarding FDA approval, intellectual property, acquisitions, and compliance with public company requirements[15](index=15&type=chunk) [Risks and Uncertainties](index=5&type=section&id=Risks%20and%20Uncertainties) Forward-looking statements are subject to various risks, many beyond the company's control, as detailed in the 'Risk Factors' section. Management cannot predict all risks or their full impact on business, and the occurrence of these events could substantially harm the business and stock price - Forward-looking statements are subject to risks and uncertainties, many beyond the company's control, as detailed in the 'Risk Factors' section[16](index=16&type=chunk) - Management cannot predict all risks or assess the full impact of all factors on the business[16](index=16&type=chunk) - The occurrence of discussed risks could substantially harm the business, results of operations, financial condition, and lead to a decline in common stock trading price[16](index=16&type=chunk) [Cautionary Statements and Safe Harbor](index=5&type=section&id=Cautionary%20Statements%20and%20Safe%20Harbor) The cautionary statements in this report apply to all forward-looking statements. The company claims safe harbor protection under the Private Securities Litigation Reform Act of 1995 and assumes no obligation to publicly update these statements unless required by law - Cautionary statements in this report are applicable to all related forward-looking statements[17](index=17&type=chunk) - The company claims protection of the safe harbor for forward-looking statements under the **Private Securities Litigation Reform Act of 1995**[17](index=17&type=chunk) - Eton assumes no obligation to publicly update forward-looking statements or reasons for differing actual results, except as required by law[17](index=17&type=chunk) [PART I](index=6&type=section&id=PART%20I) [Item 1. Business](index=6&type=section&id=Item%201.%20Business) Eton Pharmaceuticals is a specialty pharmaceutical company established in 2017, focused on developing, acquiring, and commercializing innovative products, particularly hospital injectables and pediatric rare disease treatments. The company has successfully submitted nine product candidates to the FDA, with three already approved and commercially launched. Eton's strategy emphasizes leveraging business development expertise and the 505(b)(2) regulatory pathway to build a diversified portfolio of Orphan Drugs and Royalty Products, aiming for high returns with a scalable business model [Overview](index=6&type=section&id=Overview) - Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company founded in **2017**, focused on developing, acquiring, and commercializing innovative pharmaceutical products that fulfill an unmet patient need[22](index=22&type=chunk) - The company has submitted **nine product candidates** to the U.S. Food & Drug Administration (FDA), with **three already approved** and commercially launched[22](index=22&type=chunk) - Eton plans to continue growing its business through the acquisition of additional late-stage, high-value product candidates[22](index=22&type=chunk) [Product Portfolio](index=6&type=section&id=Product%20Portfolio) - Eton's product portfolio is comprised of **two categories**: Orphan Drugs and Royalty Products[23](index=23&type=chunk) [Orphan Drugs](index=6&type=section&id=Orphan%20Drugs) Eton's Orphan Drug category focuses on products for rare diseases, defined as impacting fewer than 200,000 patients in the U.S. The first product, Alkindi Sprinkle®, launched in Q4 2020 for Adrenocortical Insufficiency in children, is protected by patents until 2034. Canadian rights were acquired in January 2021. Dehydrated Alcohol Injection, for methanol poisoning, has Orphan Drug Designation and a PDUFA date of May 27, 2021 - Orphan drugs typically address diseases impacting fewer than **200,000 patients** in the United States and are promoted with small, targeted sales forces and specialty pharmacies[24](index=24&type=chunk) - Alkindi Sprinkle®, Eton's first orphan product, was launched in **December 2020** as a replacement therapy for Adrenocortical Insufficiency (AI) in children under **17**, protected by **four issued patents** extending to **2034**[25](index=25&type=chunk) - Canadian rights to Alkindi Sprinkle were acquired in **January 2021**, with regulatory approval to be pursued[26](index=26&type=chunk) - Dehydrated Alcohol Injection, submitted to the FDA for methanol poisoning, has been granted Orphan Drug Designation and is expected to receive **seven years of market exclusivity** upon approval, with a **PDUFA date of May 27, 2021**[27](index=27&type=chunk) [Royalty Products](index=6&type=section&id=Royalty%20Products) Eton's royalty products category includes products that are commercialized by partners or do not require promotional activities, allowing Eton to generate high-margin revenue with a scalable business model. The portfolio currently includes seven products, two commercially launched (Biorphen®, Alaway Preservative Free®) and five under FDA review (Zonisamide, Topiramate, Lamotrigine, Cysteine Injection, Ephedrine Ready-to-Use Injection). In February 2021, Eton sold its three neurology oral liquid products to Azurity Pharmaceuticals for up to $45 million in milestones and single-digit royalties - The royalty products category includes products Eton does not commercialize or that do not require promotional activities, often managed by partners who pay milestones, royalties, and/or profit shares[28](index=28&type=chunk) - This strategy creates a highly scalable business model, allowing significant revenue growth with minimal increases in overhead expenses and headcount[29](index=29&type=chunk) Royalty Product Portfolio Summary | Product | Marketing Partner | FDA Application Status | Eton Economics | |:---|:---|:---|:---| | Biorphen® | Xellia Pharmaceuticals | Approved | 50% of Product Profit* | | Alaway Preservative Free® | Bausch Health | Approved | 12% of Net Sales | | Zonisamide Oral Suspension | Azurity Pharmaceuticals | Filed (PDUFA: May 29, 2021) | Single-Digit Royalty on Net Sales** | | Topiramate Oral Solution | Azurity Pharmaceuticals | Filed (PDUFA: Aug 6, 2021) | Single-Digit Royalty on Net Sales** | | Lamotrigine for Oral Suspension | Azurity Pharmaceuticals | Filed | Single-Digit Royalty on Net Sales** | | Cysteine Injection | Eton Pharmaceuticals | Filed | 62.5% of Product Profit | | Ephedrine Ready-to-Use Injection | Eton Pharmaceuticals | Filed (PDUFA Jun 18, 2021) | 50% of Product Profit* | *Prior to sales commission/selling costs **Eton also to receive a **total of up to $45 million** in development and commercial milestones - In **February 2021**, Eton sold its **three neurology oral liquid products** (Zonisamide, Topiramate, and Lamotrigine) to Azurity Pharmaceuticals for **up to $45 million in milestone payments** and a **single-digit royalty on net sales**[37](index=3