Apotex announces expansion of licensing agreement with Formosa Pharmaceuticals to Mexico for commercialization of clobetasol propionate ophthalmic suspension for the treatment of inflammation and pain
MEXICO CITY, May 6, 2025 /CNW/ - Apotex Inc. (referred to as "Apotex" or "the Company") today announced it has entered into an exclusive licensing agreement with Formosa Pharmaceuticals ("Formosa", 6838.TW), for exclusive rights in Mexico for the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and pain following ocular surgery, upon regulatory approval.
Apotex Inc. Logo (CNW Group/Apotex Inc.)
APP13007 was approved by the U.S. Food and Drug Administration (FDA) in 2024. APP13007's active ingredient is the corticosteroid clobetasol propionate, and it is derived from Formosa Pharma's proprietary APNT® nanoparticle formulation platform. This novel formulation proved statistically and clinically superior to its matching placebo in Phase 3 trials in the United States (p<0.001).
This license agreement for the Mexican market adds to Apotex's existing exclusive rights to this product in Canada.
"At Apotex, we are committed to delivering access to medicines and health products, and unlocking new possibilities for patients through partnerships. We are pleased to bring access to APP13007 (clobetasol propionate ophthalmic suspension, 0.05%) to the Mexican market upon regulatory approval. Our agreement with Formosa Pharmaceuticals further demonstrates Apotex's leading position as partner of choice in the Americas for pharmaceutical licensing and product acquisitions as we continue to execute our Journey of Heath growth strategy," said Alok Kanti, President, Apotex International.
"Having started our journey together in 2024, Formosa Pharma is pleased to expand the partnership with Apotex to include the Mexico territory," said Erick Co, President and CEO of Formosa Pharmaceuticals. "Our experience with Apotex's Canadian team underscored their commitment to branded and differentiated ophthalmology products, giving us full confidence that APP13007 will reach ophthalmologists and patients in Mexico as soon as possible."
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at www.apotex.com.
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We believe adjusted net income (loss) affords investors a different view of the overall financial performance of the Company than adjusted EBITDA and the GAAP measure of net income (loss) from continuing operations. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the financial tables below. Items are considered one-time in nature if they are non-recurring, infrequent or unusual and have not occurred in the past two years or are not expected to recur in the next two years, in accordance with SEC rules. Non-GAAP information should be considered as supplemental in nature and not as a substitute for, or superior to, any measure of performance prepared in accordance with GAAP. None of these metrics are presented as measures of liquidity. The way the Company measures EBITDA, adjusted EBITDA and adjusted net income (loss) may not be comparable to similarly titled measures presented by other companies and may not be identical to corresponding measures used in Company agreements. About Calavo Growers, Growers, Inc. (Nasdaq: CVGW) is a global leader in the processing and distribution of avocados, tomatoes, papayas and guacamole. Calavo products are sold under the trusted Calavo brand name, proprietary sub-brands, private label and store brands. Founded in 1924, Calavo has a rich culture of innovation, sustainable practices and market growth. The Company serves retail grocery, foodservice, club stores, mass merchandisers, food distributors and wholesalers worldwide. Calavo is headquartered in Santa Paula, California, with facilities throughout the U.S. and Mexico. Learn more about The Family of Fresh™ at Safe Harbor StatementThis press release contains statements relating to future events and results of Calavo (including financial projections and business trends) that are 'forward-looking statements,' as defined in the Private Securities Litigation Reform Act of 1995, that involve risks, uncertainties, and assumptions. These statements are based on our current expectations and are not promises or guarantees. If any of the risks or uncertainties materialize or the assumptions prove incorrect, the results of Calavo may differ materially from those expressed or implied by such forward-looking statements and assumptions. The use of words such as 'anticipates,' 'estimates,' 'expects,' 'projects,' 'intends,' 'plans' and 'believes,' among others, generally identify forward-looking statements. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including, but not limited to, any projections of revenue, gross profit, expenses, income/(loss) from unconsolidated entities, earnings, earnings per share, tax provisions, cash flows and currency exchange rates; the impact of acquisitions or debt or equity investments or other financial items; any statements of the plans, strategies and objectives of management for future operations, including execution of restructuring and integration (including information technology systems integration) plans; any statements regarding current or future macroeconomic trends or events and the impact of those trends and events on Calavo and its financial performance; statements regarding pending internal or external investigations, legal claims or tax disputes; and any statements of expectation or belief; any statements about future risks associated with doing business internationally (including possible restrictive U.S. and foreign governmental actions, such as restrictions on transfers of funds, restrictions as a result of trade protection measures such as import/export/customs duties, tariffs and/or quotas). Risks and uncertainties that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements include, but are not limited to, the following: the ability of our management team to work together successfully; the impact of weather on market conditions; seasonality of our business; sensitivity of our business to changes in market prices of avocados and other agricultural products and other raw materials including fuel, packaging and paper; changes or actions associated with USDA-APHIS and the Mexican Secretary of Agriculture, Secretariat of Agriculture and Rural Development (SADER) phytosanitary regulations (certification regulation for the importation of Hass avocados to the United States); potential disruptions to our supply chain; risks associated with potential future acquisitions, including integration; potential exposure to data breaches and other cyber-attacks on our systems or those of our suppliers or customers; dependence on large customers; dependence on key personnel and access to labor necessary for us to render services; susceptibility to wage inflation; potential for labor disputes; reliance on co-packers for a portion of our production needs; competitive pressures, including from foreign growers; risks of recalls and food-related injuries to our customers; changing consumer preferences; the impact of environmental regulations, including those related to climate change; risks associated with the environment and climate change, especially as they may affect our sources of supply; our ability to develop and transition new products and services and enhance existing products and services to meet customer needs, including but not limited to the new guacamole products referenced in this press release; risks associated with doing business internationally (including possible non-compliance with U.S. and foreign laws applicable to international trade and dealings and possible restrictive U.S. and foreign governmental actions, such as restrictions on transfers of funds and trade protection measures such as import/export/customs duties, tariffs and/or quotas and currency fluctuations); risks associated with receivables from, loans to and/or equity investments in unconsolidated entities; volatility in the value of our common stock; the impact of macroeconomic trends and events; the effects of increased interest rates on our cost of borrowing and consumer purchasing behavior; the resolution of pending internal and external investigations, legal claims and tax disputes, including an assessment imposed by the Mexican Tax Administrative Service (the 'SAT') and our defenses against collection activities commenced by the SAT; and our ability to realize the expected expense savings from the sale of the Fresh Cut business. 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Investor Contact Jeremy AppleSenior Vice PresidentFinancial Profiles, Inc. calavo@ CALAVO GROWERS, CONSOLIDATED BALANCE SHEETS (UNAUDITED) (in thousands) April 30, October 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 60,361 $ 57,031 Accounts receivable, net of allowances of $3,399 (2025) and $3,624 (2024) 57,603 41,909 Inventories 41,625 34,157 Prepaid expenses and other current assets 9,457 9,976 Advances to suppliers 10,277 14,570 Income taxes receivable 936 936 Total current assets 180,259 158,579 Property, plant, and equipment, net 51,058 54,200 Operating lease right-of-use assets 17,610 18,316 Investments in unconsolidated entities 3,004 2,424 Deferred income tax assets 7,473 7,473 Goodwill 10,211 10,211 Other assets 51,838 49,916 $ 321,453 $ 301,119 Liabilities and shareholders' equity Current liabilities: Payable to growers $ 48,568 $ 18,377 Trade accounts payable 6,808 8,742 Accrued expenses 17,491 28,149 Income tax payable 2,002 2,767 Other current liabilities 11,000 11,000 Current portion of operating leases 3,466 3,296 Current portion of finance leases 836 874 Total current liabilities 90,171 73,205 Long-term liabilities: Long-term portion of operating leases 16,466 17,476 Long-term portion of finance leases 3,873 4,274 Other long-term liabilities 4,384 4,388 Total long-term liabilities 24,723 26,138 Commitments and contingencies Shareholders' equity: Common stock ($0.001 par value, 100,000 shares authorized; 17,841 (2025) and 17,802 (2024) shares issued and outstanding) 18 18 Additional paid-in capital 178,522 177,973 Noncontrolling interest 1,554 1,444 Retained earnings 26,465 22,341 Total shareholders' equity 206,559 201,776 $ 321,453 $ 301,119 CALAVO GROWERS, CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)(in thousands, except per share amounts) Three months ended Six months ended April 30, April 30, 2025 2024 2025 2024 Net sales $ 190,546 $ 184,383 $ 344,931 $ 311,989 Cost of sales 172,457 163,845 311,114 280,691 Gross profit 18,089 20,538 33,817 31,298 Selling, general and administrative 10,303 13,020 20,590 26,483 Expenses related to Mexican tax matters 156 202 551 585 Operating income 7,630 7,316 12,676 4,230 Foreign currency (loss) gain 957 (181 ) (5 ) 1,527 Interest income 762 — 1,607 — Interest expense (204 ) (962 ) (417 ) (1,786 ) Other income, net 613 520 725 720 Income before income taxes and net income (loss) from unconsolidated entities 9,758 6,693 14,586 4,691 Income tax expense (2,536 ) (390 ) (3,791 ) (963 ) Net income (loss) from unconsolidated entities (282 ) 204 580 205 Net income from continuing operations 6,940 6,507 11,375 3,933 Net loss from discontinued operations — (408 ) — (4,091 ) Net income (loss) 6,940 6,099 11,375 (158 ) Less: Net income attributable to noncontrolling interest (90 ) (37 ) (110 ) (47 ) Net income (loss) attributable to Calavo Growers, Inc. $ 6,850 $ 6,062 $ 11,265 $ (205 ) Calavo Growers, Inc.'s net income (loss) per share: Basic Continuing Operations $ 0.38 $ 0.36 $ 0.63 $ 0.22 Discontinued Operations $ — $ (0.02 ) $ — $ (0.23 ) Net income (loss) attributable to Calavo Growers, Inc $ 0.38 $ 0.34 $ 0.63 $ (0.01 ) Diluted Continuing Operations $ 0.38 $ 0.36 $ 0.63 $ 0.22 Discontinued Operations $ — $ (0.02 ) $ — $ (0.23 ) Net income (loss) attributable to Calavo Growers, Inc $ 0.38 $ 0.34 $ 0.63 $ (0.01 ) Number of shares used in per share computation: Basic 17,815 17,800 17,841 17,800 Diluted 17,828 17,872 17,903 17,866 CALAVO GROWERS, SALES AND GROSS PROFIT BY BUSINESS SEGMENT (UNAUDITED)(in thousands) Fresh Prepared Total (All amounts are presented in thousands) Three months ended April 30, 2025 Net sales $ 174,661 $ 15,885 $ 190,546 Cost of sales 160,608 11,849 172,457 Gross profit $ 14,053 $ 4,036 $ 18,089 Three months ended April 30, 2024 Net sales $ 166,755 $ 17,628 $ 184,383 Cost of sales 150,525 13,320 163,845 Gross profit $ 16,230 $ 4,308 $ 20,538 Fresh Prepared Total (All amounts are presented in thousands) Six months ended April 30, 2025 Net sales $ 314,456 $ 30,475 $ 344,931 Cost of sales 288,266 22,848 311,114 Gross profit $ 26,190 $ 7,627 $ 33,817 Six months ended April 30, 2024 Net sales $ 279,781 $ 32,208 $ 311,989 Cost of sales 257,121 23,570 280,691 Gross profit $ 22,660 $ 8,638 $ 31,298 CALAVO GROWERS, OF ADJUSTED NET INCOME AND ADJUSTED NET INCOME PER DILUTED SHARE (UNAUDITED)(in thousands, except per share amounts) The following table presents adjusted net income (loss) and adjusted net income (loss) per diluted share, each a non-GAAP measure, and reconciles them to net income (loss) attributable to Calavo Growers, Inc., and Diluted EPS, which are the most directly comparable GAAP measures. 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Three months ended April 30, Six months ended April 30, 2025 2024 2025 2024 Net income from continuing operations $ 6,940 $ 6,507 $ 11,375 $ 3,933 Less: Net income attributable to noncontrolling interest (90 ) (37 ) (110 ) (47 ) Net income from continuing operations attributable to Calavo Growers, Inc. 6,850 6,470 11,265 3,886 Non-GAAP adjustments: Restructure costs - consulting, management recruiting and severance (a) — 550 — 1,037 Expenses related to Mexican tax matters (b) 156 202 551 585 Professional fees related to internal investigation and legal settlement and related expenses (c) 248 2,656 925 5,036 Foreign currency loss (gain) (d) (957 ) 181 5 (1,527 ) Tariffs (e) 941 — 941 — Tax impact of adjustments (f) (101 ) (936 ) (630 ) (1,334 ) Adjusted net income from continuing operations $ 7,137 $ 9,123 $ 13,057 $ 7,683 Calavo Growers, Inc.'s continuing operations per share: Diluted EPS from continuing operations (GAAP) $ 0.38 $ 0.34 $ 0.63 $ (0.01 ) Adjusted net income from continuing operations per diluted share $ 0.40 $ 0.51 $ 0.73 $ 0.43 Number of shares used in per share computation: Diluted 17,828 17,872 17,903 17,866 ________________________________(a) For the three months ended April 30, 2024, we incurred $0.6 million in severance and other costs related to the departure of certain members of management. For the six months ended April 30, 2024, we incurred $0.9 million in severance and other costs and $0.1 million in stock-based compensation related to the departure of certain members of management.(b) For the three months ended April 30, 2025 and 2024, we incurred $0.2 million of professional fees related to the Mexican tax matters. For the six months ended April 30, 2025 and 2024, we incurred $0.6 million of professional fees related to the Mexican tax matters.(c) For the three months ended April 30, 2025 and 2024, we incurred $0.2 million and $2.7 million of professional fee expenses related to the FCPA investigation in Mexico. For the six months ended April 30, 2025 and 2024, we incurred $0.9 million and $5.0 million of professional fee expenses related to the FCPA investigation in Mexico.(d) Foreign currency remeasurement gains, net of losses, were $1.0 million and $0 for the three- and six-month periods ended April 30, 2025, compared to a net loss of $0.2 million for the three-month period ended April 30, 2024 and a net gain of $1.5 million for the six-month periods ended April 30, 2024.(e) For the three and six months ended April 30, 2025, we incurred $0.9 million in costs for tariffs that were levied primarily on United States-Mexico-Canada Agreement (USMCA)-compliant goods sourced from Mexico over a three-day period (March 4, 2025 through March 6, 2025) before being lifted. Because of the abrupt and unanticipated nature of this discrete event, we were unable to pass the added cost on to customers and we believe this expense was distortive to our results for the periods ended April 30, 2025. This amount represents only the expense of this discrete 3-day tariff event and does not include other tariffs paid by the Company during the reported periods.(f) Tax impact of non-GAAP adjustments are based on effective year-to-date tax GROWERS, OF EBITDA AND ADJUSTED EBITDA (UNAUDITED)(in thousands) The following table presents EBITDA and adjusted EBITDA, each a non-GAAP measure, and reconciles them to net income (loss) attributable to Calavo Growers, Inc., which is the most directly comparable GAAP measure. During the first quarter of fiscal 2025, we modified our calculation of Adjusted Net Income and Adjusted EBITDA to remove income (loss) from unconsolidated entities from excluded items. Management believes this change enhances comparability with industry peers and provides a clearer representation of our core operating performance. Prior-period amounts have been recast for comparability where applicable. This adjustment does not impact previously reported GAAP financial results. See 'Non-GAAP Financial Measures' earlier in this release. Three months ended April 30, Six months ended April 30, 2025 2024 2025 2024 Net income from continuing operations $ 6,940 $ 6,507 $ 11,375 $ 3,933 Less: Net income attributable to noncontrolling interest (90 ) (37 ) (110 ) (47 ) Net income from continuing operations attributable to Calavo Growers, Inc. 6,850 6,470 11,265 3,886 Interest Income (762 ) (115 ) (1,607 ) (240 ) Interest Expense 204 962 417 1,786 Provision for Income Taxes 2,536 390 3,791 963 Depreciation and Amortization 1,859 2,078 3,801 4,110 Stock-Based Compensation 323 456 595 1,348 EBITDA from continuing operations $ 11,010 $ 10,241 $ 18,262 $ 11,853 Adjustments: Restructure costs - consulting, management recruiting and severance (a) — 480 — 967 Expenses related to Mexican tax matters (b) 156 202 551 585 Professional fees related to internal investigation and legal settlement and related expenses (c) 248 2,656 925 5,036 Foreign currency loss (gain) (d) (957 ) 181 5 (1,527 ) Tariffs (e) 941 — 941 — Adjusted EBITDA from continuing operations $ 11,398 $ 13,760 $ 20,684 $ 16,914 ________________________________See prior page for footnote referencesSign in to access your portfolio
