Nepafenac

Completion of Facility Enables Initiation of Phase 3 Clinical Trial of Nepafenac in Patients Undergoing Cataract Surgery AUSTIN, Texas, Sept. 12, 2023 /PRNewswire/ -- Mati Therapeutics Inc. ("Mati") announced that it has completed and now occupies a facility dedicated to manufacturing all products formulated in Mati's proprietary Evolute® sustained ocular drug delivery platform. The 10,000 square foot facility is located in Bryan, Texas and has the capacity to fulfill all manufacturing needs for both development and commercial purposes for the foreseeable future. Mati engineers designed, built, and programmed each of the robotic devices used in a multi-step process to manufacture each product in the Evolute® platform. "Following pandemic-related disruptions to global supply chains, we determined it was both time and cost effective to directly control the manufacturing process for all of the product candidates in our pipeline," said Bob Butchofsky, CEO of Mati. "Following completion and occupancy of this facility, we are now in position to initiate a Phase 3 trial of nepafenac to treat post-operative pain in patients undergoing cataract surgery. We expect to begin this trial in the coming weeks. Our ability to control our manufacturing schedule will reduce potential delays from ongoing supply chain interruptions, provide more flexibility in our development efforts, and will greatly reduce our commercial cost of goods sold." About Mati Therapeutics Inc. Mati is developing the Evolute® sustained ocular drug delivery platform, which Mati believes has the potential to treat a range of ocular indications. The platform utilizes a device called a punctal plug, which is easily inserted into a patient's punctum, or tear duct. The device has already been approved to treat dry eye syndrome, but Mati is the first company to conduct clinical trials in the U.S. using punctal plugs as an anchoring device for a drug delivery platform. A drug-eluting core is inserted into Mati's proprietary punctal plug, which allows medication to be continuously released into the tear film of the eye over a period of time. Mati believes the Evolute® platform has the potential to become a more reliable alternative to several eye drop therapies, which can be ineffective because many patients are unwilling or unable to adhere to self-administered eye-drop regimens. Mati has two candidates ready to enter Phase III pivotal trials including nepafenac for post-operative pain and dexamethasone for post-operative inflammation, both following cataract surgery. Additionally, Mati is developing travoprost, which is in Phase II trials for the treatment of glaucoma and ocular hypertension. Mati's proprietary punctal plug design has demonstrated excellent lower punctum retention rates of 92% and 96% over a 12-week follow-up period in two separate multi-center U.S. clinical trials. To learn more about Mati Therapeutics, visit . Contact: Bob Butchofsky, CEO Mati Therapeutics Inc. +1 512 720-1333 [email protected] SOURCE Mati Therapeutics

First Quarter 2023 and Recent Selected Highlights: Record revenues of $26.1 million, up 18% over $22.1 million for the prior-year quarter and 28% over sequential quarter revenues of $20.3 million. Completed transfer of New Drug Applications (NDAs) for ILEVRO®, NEVANAC®, and MAXIDEX®. Signed an agreement with a large health insurance carrier to provide ImprimisRx’s atropine.com and Klarity-C compounded formulations on a cash-pay basis to its national vision care network. Successfully launched FDA-approved IHEEZO™ at the American Society of Cataract and Refractive Surgery (“ASCRS”) annual meeting held between May 5-8, 2023. NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced results for the first quarter ended March 31, 2023. The Company also posted its first quarter Letter to Stockholders and corporate presentation to the “Investors” section of its website, harrow.com. This press release features multimedia. View the full release here: “We are excited to kick off 2023 with a strong first quarter that demonstrates the continuing successful execution of our strategic plan aimed at elevating Harrow into a leading position among top-tier U.S. eyecare pharmaceutical companies,” said Mark L. Baum, CEO of Harrow. “We are pleased that our Harrow team delivered record revenues of $26.1 million, a 28% increase over the fourth quarter of 2022, but, even more important, we see the first quarter of 2023 marking the beginning of a new revenue paradigm for Harrow. Going forward, we expect revenue growth from our branded pharmaceutical products to meaningfully outpace growth from our compounded pharmaceutical products, with revenue from branded products ultimately driving the lion’s share of our future profitability and topline growth. Based on our results to date, we are reaffirming our 2023 guidance of $135 million to $143 million in net revenues and $44 million to $50 million in adjusted EBITDA. “We believe our successful first quarter is indicative of 2023 being a catalyst-rich year for Harrow, including our recent launch of IHEEZO™ at ASCRS in San Diego. We are very excited about the growth that we are seeing from our innovative new products and formulations that are being added to our product portfolio. For details on Harrow’s growth trajectory and strategic plan, I encourage you to read our quarterly Letter to Stockholders, all of which can be found on our website at harrow.com.” First quarter 2023 figures of merit: For the Three Months Ended March 31, 2023 2022 Net revenues $ 26,103,000 $ 22,120,000 Gross margin 68 % 73 % Core gross margin(1) 76 % 75 % Net loss (6,643,000 ) (2,438,000 ) Core net (loss) income(1) (1,042,000 ) 713,000 Adjusted EBITDA(1) 5,342,000 4,940,000 Basic and diluted net loss per share (0.22 ) (0.09 ) Core basic and diluted net (loss) income per share(1): (0.03 ) 0.03 (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 in the financial tables section. Conference Call and Webcast The Company’s management team will host a conference call and live webcast today at 4:45 p.m. Eastern Time to discuss the first quarter 2023 results and provide a business update. To participate in the call, see details below: Conference Call Details: Date: Thursday, May 11, 2023 Time: 4:45 p.m. Eastern time Participant Dial-in: 1-833-953-2434 (U.S.) 1-412-317-5763 (International) Replay Dial-in (Passcode 3870402): (telephonic replay through May 18, 2023) 1-877-344-7529 (U.S.) 1-412-317-0088 (International) Webcast: (online replay through May 11, 2024) harrow.com About Harrow Harrow (Nasdaq: HROW) is a leading U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies that are accessible and affordable. Harrow owns U.S. commercial rights to ten FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, the leading U.S. ophthalmic-focused pharmaceutical compounding business, which also serves as a mail-order pharmacy licensed to ship prescription medications in all 50 states. Harrow has non-controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late-stage drug candidates being developed by Surface and Melt. 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 HEALTH, INC. CONDENSED CONSOLIDATED BALANCE SHEETS March 31, 2023 December 31, 2022 (unaudited) ASSETS Cash and cash equivalents $ 19,248,000 $ 96,270,000 All other current assets 32,439,000 21,990,000 Total current assets 51,687,000 118,260,000 All other assets 165,811,000 39,118,000 TOTAL ASSETS $ 217,498,000 $ 157,378,000 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities $ 17,708,000 $ 18,632,000 Loans payable, net of current portion and unamortized debt discount 168,850,000 104,174,000 All other liabilities 9,412,000 7,332,000 TOTAL LIABILITIES 195,970,000 130,138,000 TOTAL STOCKHOLDERS' EQUITY 21,528,000 27,240,000 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 217,498,000 $ 157,378,000 HARROW HEALTH, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS For the Three Months Ended March 31, 2023 2022 Total revenues $ 26,103,000 $ 22,120,000 Cost of sales 8,271,000 5,963,000 Gross profit 17,832,000 16,157,000 Selling, general and administrative 15,888,000 13,398,000 Research and development 734,000 658,000 Total operating expenses 16,622,000 14,056,000 Income from operations 1,210,000 2,101,000 Total other expense, net (8,141,000 ) (4,539,000 ) Income tax benefit 288,000 - Net loss $ ( 6,643,000 ) $ (2,438,000 ) Net loss per share of common stock, basic and diluted $ (0.22 ) $ (0.09 ) HARROW HEALTH, INC. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS For the Three Months Ended March 31, 2023 2022 Net cash (used in) provided by: Operating activities $ (8,214,000 ) $ 967,000 Investing activities (130,970,000 ) (410,000 ) Financing activities 62,162,000 (776,000 ) Net change in cash and cash equivalents (77,022,000 ) (219,000 ) Cash and cash equivalents at beginning of the period 96,270,000 42,167,000 Cash and cash equivalents at end of the period $ 19,248,000 $ 41,948,000 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 income (loss), excluding the effects of stock-based compensation and expenses, interest, taxes, depreciation, amortization, investment income (loss), net, loss on extinguishment of debt, 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 income (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 income (loss), for the three months ended March 31, 2023 and 2022: HARROW HEALTH, INC. RECONCILIATION OF NET LOSS TO ADJUSTED EBITDA For the Three Months Ended March 31, 2023 2022 GAAP net loss $ (6,643,000 ) $ (2,438,000 ) Stock-based compensation and expenses 1,633,000 2,016,000 Interest expense, net 4,747,000 1,792,000 Income tax benefit (288,000 ) - Depreciation 292,000 419,000 Amortization of intangible assets 2,207,000 404,000 Investment (income) loss, net (2,042,000 ) 2,747,000 Other expense, net 5,436,000(1) - Adjusted EBITDA $ 5,342,000 $ 4,940,000 (1) Includes $5,465,000 for the loss on extinguishment of debt. Core Results Harrow Core Results, including core gross margin, core net income (loss), core operating income (loss), core basic and diluted income (loss) per share, and core operating margin, exclude all amortization and impairment charges of intangible assets, excluding software development costs, 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”), preferred stock dividends, and 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, a non-GAAP measure, to the most comparable GAAP measure for the three months ended March 31, 2023 and 2022: For the Three Months Ended March 31, 2023 GAAP Results Amortization of Certain Intangible Assets Investment Gains Other Items Core Results Gross profit $ 17,832,000 $ 2,045,000 $ - $ - $ 19,877,000 Gross margin 68 % 76 % Operating income 1,210,000 2,207,000 - - 3,417,000 Loss before taxes (6,931,000 ) 2,207,000 (2,042,000 ) 5,436,000 (1,330,000 ) Tax benefit 288,000 - - - 288,000 Net loss (6,643,000 ) 2,207,000 (2,042,000 ) 5,436,000 (1,042,000 ) Basic and diluted loss per share ($)(1): (0.22 ) (0.03 ) Weighted average number of shares of common stock outstanding: Basic 30,289,730 30,289,730 For the Three Months Ended March 31, 2022 GAAP Results Amortization of Certain Intangible Assets Investment Losses Other Items Core Results Gross profit $ 16,157,000 $ 341,000 $ - $ - $ 16,498,000 Gross margin 73 % 75 % Operating income 2,101,000 404,000 - - 2,505,000 (Loss) income before taxes (2,438,000 ) 404,000 2,747,000 - 713,000 Taxes - - - - - Net (loss) income (2,438,000 ) 404,000 2,747,000 - 713,000 Basic (loss) earnings per share ($)(1) (0.09 ) 0.03 Diluted (loss) earnings per share ($)(1) (0.09 ) 0.03 Weighted average number of shares of common stock outstanding: Basic 27,226,819 27,226,819 Diluted 27,226,819 28,317,740 (1) Core basic and diluted (loss) earnings per share is calculated using the weighted-average number of shares of common stock outstanding during the period. Core basic and diluted (loss) earnings per share also contemplates dilutive shares associated with equity-based awards as described in Note 2 and elsewhere in the Condensed Consolidated Financial Statements included in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. View source version on businesswire.com: Contacts Jamie Webb, Director of Communications and Investor Relations jwebb@harrowinc.com 615-733-4737 Source: Harrow Health, Inc. Smart Multimedia Gallery Document Harrow First Quarter 2023 Letter to Stockholders Logo View this news release online at: