Eton Pharmaceuticals, Inc.

PKU GOLIKE® is a commercial ultra-rare disease medical formula complementary to Eton's existing metabolic franchise and specialty call pointTransaction is expected to be accretive to 2024 earningsEstimated peak sales of more than $10 million annuallyU.S. phenylketonuria ("PKU") medical formula market estimated to be $100 million annually DEER PARK, Ill., March 22, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has acquired U.S. rights to PKU GOLIKE® from RELIEF THERAPEUTICS Holding SA (“Relief”) (SIX: RLF, OTCQB: RLFTF, RLFTY). “We are excited to be partnering with Relief on PKU GOLIKE in the United States. After extensive discussions with metabolic geneticists, dieticians, and PKU patients, we believe PKU GOLIKE is the best product in the estimated $100 million U.S. PKU medical formula market. With our sales force and existing relationships in the metabolic community, we believe we can significantly increase the awareness, education, and adoption of this important product,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “We are very pleased to gain this partnership with Eton for PKU GOLIKE patients in the US as it is aligned with RELIEF’s strategy to enhance patient access to our innovative products,” said Michelle Lock, interim CEO of Relief. “Eton brings valuable know-how in the metabolic space as well as commercialization expertise for products in rare diseases.” PKU is a rare inherited disorder caused by a defect in the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain proteins. Treatment of PKU requires patients to follow a strict diet that severely limits phenylalanine content and typically requires low protein foods supplemented by phenylalanine-free medical formulas. Excessive levels of phenylalanine in the blood accumulate in the brain and inhibit proper brain development. It is estimated that 8,000 PKU patients in the U.S. utilize medical formulas to manage their diet. PKU GOLIKE® is a next generation medical formula product engineered with the patent protected, pharmaceutical grade Physiomimic™ technology for the dietary management of PKU under medical supervision. PKU GOLIKE’s taste-masked, odor-free coating technology is designed to provide a better taste and a superior experience compared to alternative PKU medical formulas. In addition, PKU GOLIKE’s delayed amino acid release formulation is designed to keep patients full for a longer period of time. Relief launched PKU GOLIKE Granules in the United States in the fourth quarter of 2022 and the PKU GOLIKE Tropical Bar in the second quarter of 2023. Only a few months into the product’s launch, PKU GOLIKE’s fourth quarter net sales in the U.S. were at an annual run rate of more than $1 million. Relief, through its subsidiary APR, has commercialized PKU GOLIKE in Europe since 2019 and seen strong adoption. Eton plans to promote PKU GOLIKE with its existing metabolic sales force, which currently promotes Eton’s Carglumic Acid, Betaine, and Nitisinone products. PKU patients’ care is typically overseen by metabolic geneticists and their support staff of nurse practitioners and registered dieticians. Medical formulas for PKU are frequently covered by insurance and are regulated by the FDA as medical food products. PKU GOLIKE is exclusively distributed in the United States by Pentec Health. Patients and healthcare professionals seeking additional information on the product can visit www.PKUGOLIKE.com. The transaction is expected to be accretive to Eton’s 2024 earnings and the company expects peak sales of more than $10 million annually. As part of the transaction, Eton also received U.S. rights to Relief’s GOLIKE medical formulas line extensions under development for the management of the metabolic conditions tyrosinemia and homocystinuria, which are expected to launch in 2025 and 2026, respectively. Eton has also been granted a right of first negotiation for Relief’s RLF-OD032 development candidate. RLF-OD032 is an innovative drug product candidate under development for the treatment of PKU and is expected to be filed with the FDA in the second half of 2025 as a 505(b)(2) New Drug Application. Relief will continue to own PKU GOLIKE rights outside the United States. About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com. About RELIEF THERAPEUTICS Holding SA Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented Physiomimic™ and TEHCLO™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare metabolic disorders, rare skin diseases and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Relief’s mission is to provide therapeutic relief to those suffering from rare diseases and is being advanced by an international team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief is headquartered in Geneva, with additional offices in Balerna, Switzerland, Offenbach am Main, Germany and Monza, Italy. Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com. About Phenylketonuria (PKU) Phenylketonuria (PKU) is caused by a defect of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of Phe from the consumption of foods containing protein or aspartame. Untreated PKU can result in global developmental delay or severe irreversible intellectual disability, as well as growth failure, hypopigmentation, motor deficits, ataxia and seizures. Living with PKU requires a limited diet and very careful management. If left unmanaged, PKU can lead to devastating consequences, such as brain damage. People living with PKU do not have the ability to metabolize Phe, which is found in many foods, and they require supplementation of amino acid-based phenylalanine-free medical formulas as part of an effort to prevent protein deficiency and optimize metabolic control. Medical formulas used in PKU are challenged to provide a range of amino acids slowly and without a medicinal aftertaste. About PKU GOLIKE PKU GOLIKE® products are foods for special medical purposes (FSMPs) for the dietary management of PKU in both children and adults for use under medical supervision. Developed with Relief’s proprietary, patent-protected Physiomimic Technology™ drug delivery platform, PKU GOLIKE® products are the first prolonged-release amino acid FSMPs, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins. The special coating also masks the unpleasant taste, odor and aftertaste of the amino acids. PKU GOLIKE® granules are flavorless and can be mixed with many foods. PKU GOLIKE® products contain all 19 amino acids that people with PKU need to maintain neurological and muscular health and is fortified with 27 essential vitamins and minerals, including ones normally found in protein-rich foods like iron, calcium and vitamin B12. The PKU GOLIKE® line of products are available in convenient packets (PKU GOLIKE Plus® 3-16 and 16+) and medical formula bars (PKU GOLIKE BAR®). PKU GOLIKE® products have been commercially available in the U.S. since October 2022. For more information, visit www.pkugolike.com (Please note this site is intended for U.S. audiences only). Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations:Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com

GENEVA, SWITZERLAND / ACCESSWIRE / March 22, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY ) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced it has granted an exclusive license to Eton Pharmaceuticals, Inc. (Nasdaq: ETON) (Eton) for the commercialization of GOLIKE ® family of products in the United States. "This transition is fully aligned with Relief's strategy of moving the GOLIKE products into partnership models in the U.S. and Europe. We are very pleased to be establishing this partnership with Eton for GOLIKE patients in the U.S. given their valuable experience in the metabolic area," said Michelle Lock, interim CEO of Relief. "We are excited to be partnering with Relief on PKU GOLIKE in the United States. After extensive discussions with metabolic geneticists, dieticians, and PKU patients, we believe PKU GOLIKE is the best product in the estimated $100 million U.S. PKU medical formula market. With our sales force and existing relationships in the metabolic community, we believe we can significantly increase the awareness, education, and adoption of this important product," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. Under the terms of the agreement, Relief will receive an upfront payment of $2.2 million and is eligible to receive an additional $2.0 million in sales milestones payments as well as mid-teens royalties on net sales. In the fourth quarter of 2023, PKU GOLIKE's annualized net sales exceeded $1 million in the U.S., continuing its growth trajectory since its launch in late 2022. As part of the agreement, Eton also received U.S. rights to Relief's GOLIKE Medical Food line extensions under development for the management of other inherited rare metabolic diseases such as tyrosinemia and homocystinuria, which are both expected to launch in 2025 and 2026 under the same trademark. Relief is also in discussions with Eton related to additional development assets, including RLF-OD032. RLF‑OD032 is an innovative drug product candidate under development for the treatment of PKU expected to be filed for approval before the FDA in H2/2025 as 505(b)(2) application. Relief will continue to fully own GOLIKE rights outside the United States. About Relief Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief's portfolio offers a balanced mix of marketed, revenue-generating products, our proprietary, globally patented Physiomimic™ and TEHCLO™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare metabolic disorders, rare skin diseases and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Relief's mission is to provide therapeutic relief to those suffering from rare diseases and is being advanced by an international team of well-established, experienced biopharma industry leaders with extensive research, development and rare disease expertise. Relief is headquartered in Geneva, with additional offices in Balerna, Switzerland, Offenbach am Main, Germany and Monza, Italy. Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, please visit our website or follow Relief on LinkedIn . About Eton Pharmaceuticals Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. It currently has five commercial rare disease products: ALKINDI SPRINKLE ® , PKU GOLIKE ® , Carglumic Acid, Betaine Anhydrous, and Nitisinone. Eton has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO ® hydrocortisone autoinjector. For more information, visit . About Phenylketonuria (PKU) Phenylketonuria (PKU) is caused by a defect of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of Phe from the consumption of foods containing protein or aspartame. Untreated PKU can result in global developmental delay or severe irreversible intellectual disability, as well as growth failure, hypopigmentation, motor deficits, ataxia and seizures. Living with PKU requires a limited diet and very careful management. If left unmanaged, PKU can lead to devastating consequences, such as brain damage. People living with PKU do not have the ability to metabolize Phe, which is found in many foods, and they require supplementation of amino acid-based phenylalanine-free Medical Foods to prevent protein deficiency and optimize metabolic control. Currently available Medical Foods may lead to poor or suboptimal clinical outcomes and compliance because they are rapidly absorbed and are characterized by an unpleasant odor and aftertaste. Such factors contribute to barriers to social interaction for PKU patients, further limiting Medical Foods compliance and exposing patients to the risks of poor disease control. About PKU GOLIKE PKU GOLIKE ® products are Medical Foods for the dietary management of PKU in both children and adults. Developed with the Relief proprietary, patent-protected Physiomimic Technology™ drug delivery platform, PKU GOLIKE ® products are the first prolonged-release amino acid Medical Food, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins. The special coating also masks the unpleasant taste, odor and aftertaste of the amino acids. PKU GOLIKE ® granules are flavorless and can be mixed with many foods. PKU GOLIKE ® granule products contain all 19 amino acids that people with PKU need to maintain neurological and muscular health and is fortified with vitamins and minerals, including ones normally found in protein-rich foods like iron, calcium, and vitamin B12. The PKU GOLIKE ® line of products is available in convenient packets (PKU GOLIKE Plus ® 3-16 and 16+) and medical food bars (PKU GOLIKE BAR ® ). PKU GOLIKE ® products have been commercially available in the U.S. since October 2022. For more information, visit (this site is intended for U.S. audiences only). CONTACT : RELIEF THERAPEUTICS Holding SA Avenue de Sécheron 15 1202 Geneva Switzerland contact@relieftherapeutics.com DISCLAIMER This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief's filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief's filings with the SEC are available on the SEC EDGAR database at . Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date. SOURCE: Relief Therapeutics Holdings AG View the original press release on accesswire.com

Full-Year 2023 Highlights: Revenues of $130.2 million, an increase of 47% over 2022 revenues of $88.6 million. GAAP net loss of $(24.4 million) compared with $(14.1 million) for the prior-year period. Adjusted EBITDA of $28.1 million, an increase of 116% over 2022 Adjusted EBITDA of $13.0 million. Cash from operating activities of $3.8 million. GAAP gross margin was 70% compared with 71% in the prior-year period. Core gross margin was 77% compared with 73% in the prior-year period. Cash and cash equivalents of $83 million, including investments in Eton Pharmaceuticals, as of December 31, 2023. NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, announced results for the fourth quarter and year ended December 31, 2023. The Company also posted its fourth quarter and year-end Letter to Stockholders and corporate presentation to the “Investors” section of its website, harrow.com. The Company encourages all Harrow stockholders to review these documents, which provide additional details concerning the historical quarterly period as well as the future expectations for the business. This press release features multimedia. View the full release here: “This past year, little Harrow grew up, transforming from a company focused exclusively on its market-leading ImprimisRx compounded business, to a growing leader in the North American ophthalmic pharmaceuticals market – with a total 18 branded products,” said Mark L. Baum, CEO of Harrow. “In addition to the significant revenue and Adjusted EBIDTA growth the team delivered, we launched products and began to generate cash from our Big Three products – IHEEZO, VEVYE and TRIESENCE. Finally, we also attracted experienced, well connected, and highly motivated talent to join Harrow – setting the table beautifully for 2024 and for many years to come, when we expect significant growth from IHEEZO, continued success with our VEVYE launch, and having TRIESENCE back in inventory and available, potentially this year. In summary, supported by the tremendous progress we made in 2023, this year, too, is shaping up to be another exciting year of growth. I am confident that we have the products, resources, and people to take full advantage of the opportunities we see ahead of us today and for many years to come.” Fourth quarter and year-end 2023 figures of merit: For the Three Months Ended December 31, For the Year Ended December 31, 2023 2022 2023 2022 Net revenues $ 36,355,000 $ 20,329,000 $ 130,193,000 $ 88,595,000 Gross margin 69 % 70 % 70 % 71 % Core gross margin(1) 75 % 71 % 77 % 73 % Net (loss) income (9,148,000 ) 1,055,000 (24,411,000 ) (14,086,000 ) Core net (loss) income(1) (7,016,000 ) 2,103,000 (11,512,000 ) (1,375,000 ) Adjusted EBITDA(1) 2,563,000 1,089,000 28,119,000 13,017,000 Basic and diluted net (loss) income per share (0.26 ) 0.04 (0.75 ) (0.51 ) Core net (loss) income per share(1): Basic (0.20 ) 0.08 (0.35 ) (0.05 ) Diluted (0.20 ) 0.07 (0.35 ) (0.05 ) (1) Core gross margin, core net (loss) income , core basic and diluted net (loss) income per share (collectively, “Core Results”), and Adjusted EBITDA are non‑GAAP measures. For additional information, including a reconciliation of such Core Results and Adjusted EBITDA to the most directly comparable measures presented in accordance with GAAP, see the explanation of non-GAAP measures and reconciliation tables at the end of this release. Conference Call and Webcast The Company’s management team will host a conference call and live webcast tomorrow morning, Wednesday, March 20, 2024, at 8:00 a.m. Eastern Time to discuss the fourth quarter and year-end 2023 results and provide a business update. To participate in the call, see details below: Conference Call Details: Date: Wednesday, March 20, 2024 Time: 8:00 a.m. Eastern time Participant Dial-in: 1-833-953-2434 (U.S.) 1-412-317-5763 (International) Replay Dial-in (Passcode 6766979): (telephonic replay through March 27, 2024) 1-877-344-7529 (U.S.) 1-412-317-0088 (International) Webcast: (online replay through March 20, 2025) harrow.com About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the North American market. Harrow helps eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of patients each year. For more information about Harrow, please visit harrow.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. HARROW, INC. CONDENSED CONSOLIDATED BALANCE SHEETS December 31, 2023 December 31, 2022 (unaudited) ASSETS Cash and cash equivalents $ 74,085,000 $ 96,270,000 All other current assets 65,397,000 21,990,000 Total current assets 139,482,000 118,260,000 All other assets 172,682,000 39,118,000 TOTAL ASSETS $ 312,164,000 $ 157,378,000 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities $ 49,344,000 $ 18,632,000 Loans payable, net of unamortized debt discount 183,172,000 104,174,000 All other liabilities 9,237,000 7,332,000 TOTAL LIABILITIES 241,753,000 130,138,000 TOTAL STOCKHOLDERS' EQUITY 70,411,000 27,240,000 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 312,164,000 $ 157,378,000 HARROW, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS For the Three Months Ended December 31, For the Year Ended December 31, 2023 2022 2023 2022 Net revenues $ 36,355,000 $ 20,329,000 $ 130,193,000 $ 88,595,000 Cost of sales 11,302,000 6,165,000 39,640,000 25,383,000 Gross profit 25,053,000 14,164,000 90,553,000 63,212,000 Selling, general and administrative 26,212,000 15,239,000 83,090,000 58,243,000 Research and development 3,336,000 703,000 6,652,000 3,050,000 Impairment of long-lived assets 380,000 - 380,000 - Total operating expenses 29,928,000 15,942,000 90,122,000 61,293,000 (Loss) income from operations (4,875,000 ) (1,778,000 ) 431,000 1,919,000 Total other (expense) income, net (4,808,000 ) 2,833,000 (24,141,000 ) (15,930,000 ) Income tax benefit (expense) 535,000 - (701,000 ) (75,000 ) Net loss (income) attributable to Harrow, Inc. $ (9,148,000 ) $ 1,055,000 $ (24,411,000 ) $ (14,086,000 ) Net loss (income) per share of common stock, basic and diluted $ (0.26 ) $ 0.04 $ (0.75 ) $ (0.51 ) HARROW, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS For the Year Ended December 31, 2023 2022 Net cash provided by (used in): Operating activities $ 3,840,000 $ 1,705,000 Investing activities (152,553,000 ) (1,743,000 ) Financing activities 126,528,000 54,141,000 Net change in cash and cash equivalents (22,185,000 ) 54,103,000 Cash and cash equivalents at beginning of the period 96,270,000 42,167,000 Cash and cash equivalents at end of the period $ 74,085,000 $ 96,270,000 Non-GAAP Financial Measures In addition to the Company’s results of operations determined in accordance with U.S. generally accepted accounting principles (GAAP), which are presented and discussed above, management also utilizes Adjusted EBITDA and Core Results, unaudited financial measures that are not calculated in accordance with GAAP, to evaluate the Company’s financial results and performance and to plan and forecast future periods. Adjusted EBITDA and Core Results are considered “non‑GAAP” financial measures within the meaning of Regulation G promulgated by the SEC. Management believes that these non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results, provide a more complete understanding of the Company’s results of operations and the factors and trends affecting its business. Management believes Adjusted EBITDA and Core Results provide meaningful supplemental information regarding the Company’s performance because (i) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making; (ii) they exclude the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance; and (iii) they are used by institutional investors and the analyst community to help analyze the Company’s results. However, Adjusted EBITDA, Core Results, and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non‑GAAP financial measures used by the Company and the way they are calculated may differ from the non-GAAP financial measures or the calculations of the same non‑GAAP financial measures used by other companies, including the Company’s competitors. Adjusted EBITDA The Company defines Adjusted EBITDA as net loss, excluding the effects of stock‑based compensation and expenses, impairment of intangible assets, interest, taxes, depreciation, amortization, investment (income) loss, net, and, if any and when specified, other non-recurring income or expense items. Management believes that the most directly comparable GAAP financial measure to Adjusted EBITDA is net loss. Adjusted EBITDA has limitations and should not be considered as an alternative to gross profit or net loss as a measure of operating performance or to net cash provided by (used in) operating, investing, or financing activities as a measure of ability to meet cash needs. The following is a reconciliation of Adjusted EBITDA, a non-GAAP measure, to the most comparable GAAP measure, net loss, for the three months and year ended December 31, 2023, and for the same periods in 2022: HARROW, INC. RECONCILIATION OF NET LOSS TO ADJUSTED EBITDA For the Three Months Ended December 31, For the Year Ended December 31, 2023 2022 2023 2022 GAAP net (loss) income $ (9,148,000 ) $ 1,055,000 $ (24,411,000 ) $ (14,086,000 ) Stock-based compensation and expenses 4,175,000 2,033,000 15,696,000 7,974,000 Impairment of intangible assets 380,000 - 380,000 - Interest expense, net 5,124,000 1,858,000 21,324,000 7,244,000 Income tax (benefit) expense (535,000 ) - 701,000 75,000 Depreciation 435,000 387,000 1,530,000 1,477,000 Amortization of intangible assets 2,448,000 378,000 10,082,000 1,578,000 Investment (income) loss, net (416,000 ) 670,000 (3,092,000 ) 14,047,000 Loss on disposal of equipment 146,000 69,000 168,000 69,000 Gain on sale of non-ophthalmology assets - (5,259,000 ) - (5,259,000 ) Other expense (income), net (46,000 ) (102,000 ) 5,741,000 (1) (102,000 ) Adjusted EBITDA $ 2,563,000 $ 1,089,000 $ 28,119,000 $ 13,017,000 (1) Includes $5,465,000 for the loss on extinguishment of debt. Core Results Harrow Core Results, including core gross margin, core net (loss) income, and core basic and diluted loss per share exclude (1) all amortization and impairment charges of intangible assets, excluding software development costs, (2) net gains and losses on investments and equity securities, including equity method gains and losses and equity valued at fair value through profit and loss (“FVPL”), and preferred stock dividends, and (3) gains/losses on forgiveness of debt. In other periods, Core Results may also exclude fair value adjustments of financial assets in the form of options to acquire a company carried at FVPL, obligations related to product recalls, certain acquisition‑related items, restructuring charges/releases and associated items, related legal items, gains/losses on early extinguishment of debt or debt modifications, impairments of property, plant and equipment and software, as well as income and expense items that management deems exceptional and that are or are expected to accumulate within the year to be over a $100,000 threshold. The following is a reconciliation of Core Results, non-GAAP measures, to the most comparable GAAP measures for the three months and year ended December 31, 2023, and for the same periods in 2022: For the Three Months Ended December 31, 2023 GAAP Results Amortization of Certain Intangible Assets Investment Gains Other Items Core Results Gross profit $ 25,053,000 $ 2,140,000 $ - $ - $ 27,193,000 Gross margin 69 % 75 % Operating (loss) income (4,875,000 ) 2,448,000 - - (2,427,000 ) (Loss) income before taxes (9,683,000 ) 2,448,000 (416,000 ) 100,000 (7,551,000 ) Tax benefit 535,000 - - - 535,000 Net (loss) income (9,148,000 ) 2,448,000 (416,000 ) 100,000 (7,016,000 ) Basic and diluted loss per share ($)(1) (0.26 ) (0.20 ) Weighted average number of shares of common stock outstanding, basic and diluted 35,353,848 35,353,848 For the Year Ended December 31, 2023 GAAP Results Amortization of Certain Intangible Assets Investment Gains Other Items Core Results Gross profit $ 90,553,000 $ 9,314,000 $ - $ - $ 99,867,000 Gross margin 70 % 77 % Operating income 431,000 10,082,000 - - 10,513,000 (Loss) income before taxes (23,710,000 ) 10,082,000 (3,092,000 ) 5,909,000 (12,899,000 ) Tax expense (701,000 ) - - - (701,000 ) Net (loss) income (24,411,000 ) 10,082,000 (3,092,000 ) 5,909,000 (11,512,000 ) Basic and diluted loss per share ($)(1) (0.75 ) (0.35 ) Weighted average number of shares of common stock outstanding, basic and diluted 32,616,777 32,616,777 For the Three Months Ended December 31, 2022 GAAP Results Amortization of Certain Intangible Assets Investment Losses Core Results Gross profit $ 14,164,000 $ 341,000 $ - $ 14,505,000 Gross margin 70 % 71 % Operating (loss) income (1,778,000 ) 378,000 - (1,400,000 ) Income before taxes 1,055,000 378,000 670,000 2,103,000 Tax expense - - - - Net income 1,055,000 378,000 670,000 2,103,000 Income per share ($)(1): Basic 0.04 0.08 Diluted 0.04 0.07 Weighted average number of shares of common stock outstanding: Basic 27,958,392 27,958,392 Diluted 29,426,567 29,426,567 For the Year Ended December 31, 2022 GAAP Results Amortization of Certain Intangible Assets Investment Losses Core Results Gross profit $ 63,212,000 $ 1,364,000 $ - $ 64,576,000 Gross margin 71 % 73 % Operating income 1,919,000 1,578,000 - 3,497,000 (Loss) Income before taxes (14,011,000 ) 1,578,000 11,133,000 (1,300,000 ) Tax expense (75,000 ) - - (75,000 ) Net (loss) income (14,086,000 ) 1,578,000 11,133,000 (1,375,000 ) Basic and diluted (loss) per share ($)(1) (0.51 ) (0.05 ) Weighted average number of shares of common stock outstanding, basic and diluted 27,460,968 27,460,968 (1) Core basic and diluted loss per share is calculated using the weighted-average number of shares of common stock outstanding during the period. Core basic and diluted loss per share also contemplates dilutive shares associated with equity-based awards as described in Note 2 and elsewhere in the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.