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Globe and Mail
2 days ago
- Business
- Globe and Mail
Medexus Announces Fiscal Q1 2026 Results, Including Positive Results from US Launch of GRAFAPEX (treosulfan) for Injection
Fiscal Q1 2026 net revenue of $24.6 million, net income of $0.5 million, operating income of $0.9 million, and Adjusted EBITDA* of $3.4 million $3.0 million of product-level net revenue from GRAFAPEX in fiscal Q1 2026, relative to $3.0 million of personnel and infrastructure investments, further supporting Medexus's confidence in the product's potential Management to host conference call at 8:00 AM Eastern time on Wednesday, August 13, 2025 Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - August 12, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company's first fiscal quarter ended June 30, 2025 (the company's fiscal Q1 2026). All dollar amounts in this press release are in United States dollars unless specified otherwise. Key business update Medexus is currently focused on delivering strong performance from GRAFAPEX. March 2025 was the first full month, and fiscal Q1 2026 was the first full fiscal quarter, in which Medexus recognized product-level net revenue from GRAFAPEX, which totaled $3.0 million for fiscal Q1 2026, relative to $3.0 million of GRAFAPEX personnel and infrastructure investments. Medexus also remains focused on delivering strong overall performance across the company's portfolio of products in both the United States and Canada. Medexus has seen a positive market response to GRAFAPEX to date, with progress consistent with Company expectations: As of June 30, 2025, nine large commercial payers, together covering an estimated 48 million patient lives, and 14 individual healthcare institutions, representing 8% of the 180 transplant centers in the United States, have made positive formulary inclusion determinations, a promising indicator of the product's commercial potential. An additional 29 commercial payers have added GRAFAPEX on their "prior authorization" lists. Wholesaler data as of June 30, 2025 shows that 36 of the 180 transplant centers, representing an estimated 24% of total allo-HSCT procedures performed in the United States annually (Source: Allogeneic HSCT in HRSA 2016-2020; Health Resources and Services Administration), have already ordered GRAFAPEX for procedures in their institutions. Medexus expects that product-level net revenue from GRAFAPEX in fiscal Q2 2026 will be $3.0 million to $3.5 million, taking into account the wholesaler purchasing patterns observed to date and expected seasonality attributable to a lower frequency of procedures scheduled during summer months. Based on product-level performance to date, Medexus expects that GRAFAPEX will be accretive to quarterly operating cash flows by fiscal Q3 2026 (calendar Q4 2025). Medexus also continues to expect that the annual product-level Adjusted Gross Margin* of GRAFAPEX will ultimately be approximately 80%, although, as demonstrated by product-level Adjusted Gross Margin* for fiscal Q1 2026, product level Adjusted Gross Margin* will be slightly higher in the initial months or quarters after commercial launch primarily due to the evolving reimbursement and tariff dynamics for the product (including as discussed below). "The strong initial performance of GRAFAPEX™ is particularly important as other products in our portfolio shift to the later stages of their product life cycle," commented Ken d'Entremont, Chief Executive Officer of Medexus. "For instance, Rupall's revenues have experienced erosion after the loss of its exclusivity period in January 2025. Over time, we expect product-level performance of GRAFAPEX™ to significantly outweigh the relatively smaller impact of this decline in Rupall product-level performance in this transitional period. We design this portfolio approach to stay agile, resilient, and ultimately successful over the long term." Medexus views product performance to date, and the response from the market and the attention to treosulfan from the medical and scientific community, as consistent with the Company's confidence that GRAFAPEX will make a substantial contribution to allo-HSCT in the United States, and also solidify Medexus's leadership position in this therapeutic field. Financial highlights Key financial highlights for fiscal Q1 2026 include the following: Net revenue of $24.6 million, a decrease of $2.7 million, or 9.9%, compared to $27.3 million for fiscal Q1 2025. The $2.7 million year-over-year net revenue decrease was primarily due to reduced net sales of Rupall (due to significant generic competition, resulting in lower unit demand, and the effects of the resulting effective unit-level price reductions) and Gleolan in the United States (due to the March 2025 termination of the US Gleolan Agreement), partially offset by $3.0 million of product-level net revenue from GRAFAPEX in fiscal Q1 2026. Adjusted EBITDA* of $3.4 million, a decrease of $2.7 million, or 44.3%, compared to $6.1 million for fiscal Q1 2025. The $2.7 million year-over-year Adjusted EBITDA* decrease was primarily due to the effect of significant generic competition on Rupall. Operating income of $0.9 million, a decrease of $3.1 million, or 77.5%, compared to $4.0 million for fiscal Q1 2025. Net income of $0.5 million, a decrease of $1.5 million compared to net income of $2.0 million for fiscal Q1 2025. Available liquidity of $9.3 million (June 30, 2025), consisting of cash and cash equivalents, compared to $24.0 million (March 31, 2025). The primary factor in this net decrease in cash was a payment of $15.5 million that Medexus made in June 2025 under the terms of a June 2025 amendment to the Company's credit agreement. Cash provided by operating activities of $3.9 million, a decrease of $4.3 million compared to $8.2 million for fiscal Q1 2025. * Refer to "Non-GAAP measures" at the end of this press release for information about non-GAAP measures and related items, including Adjusted EBITDA and Adjusted Gross Margin. "We are very pleased with the successful launch of GRAFAPEX™ in the United States," commented Ken d'Entremont, Chief Executive Officer of Medexus. "We believe this sequential quarter-over-quarter momentum we have seen will continue to build as GRAFAPEX™ is added to the formularies of additional key institutions and insurers, expanding patient access and driving further adoption. The positive initial response we have seen to date, including full results from the first full fiscal quarter of GRAFAPEX™ commercial availability, supports our expectation that GRAFAPEX™ will be accretive to quarterly operating cash flows by calendar Q4 2025, which is our fiscal Q3 2026." Brendon Buschman, Chief Financial Officer of Medexus, added: "In addition to the successful progress on GRAFAPEX™ commercialization, we achieved $0.5 million of positive net income for fiscal Q1 2026, and a healthy $3.4 million of Adjusted EBITDA* from $24.6 million of net revenue. We realized gross margin of 56.0% and Adjusted Gross Margin* of 65.5% for fiscal Q1 2026, compared to last year's 54.4% and 59.3%, respectively, demonstrating meaningful year-over-year improvement relative to steady gross profits of $13.8 million and $14.8 million and Adjusted Gross Profits* of $16.1 million and 16.2 million, respectively. These strong results provided $3.9 million in cash flow from operating activities, which we have used in part to continue to repay principal and interest under our term loan, substantially reducing total debt under our credit facilities by $15.5 million in fiscal Q1 2026 - meaning that total debt now sits at a combined $22.0 million as of June 30, 2025, with remaining scheduled principal payments of $1.1 million in each of September and December 2025." Mr Buschman concluded: "We have entered fiscal year 2026 with strong momentum and expect continued quarter-over-quarter performance as our commercialization efforts for GRAFAPEX™ advance. Overall, we continue to execute with discipline and focus as we position Medexus for the opportunities ahead." Operational highlights Leading products Hematology and hemato-oncology GRAFAPEX (US): Medexus has seen a positive market response to GRAFAPEX since the US commercial launch of the product in February 2025. Based on internal estimates and research, and the preliminary market response to GRAFAPEX, Medexus continues to expect that annual product-level net revenue from GRAFAPEX will exceed US$100 million within five years after commercial launch, with the specific nature and level of success of Medexus's commercialization initiatives in support of GRAFAPEX, among other factors, determining the extent to which the Company realizes this potential. In August 2025, the US Centers for Medicare & Medicaid Services (CMS) approved New Technology Add-On Payment (NTAP) reimbursement for eligible cases involving the use of GRAFAPEX for CMS's fiscal year 2026, which runs from October 1, 2025 to September 30, 2026. The NTAP program is designed to provide temporary supplemental reimbursement to institutions that use designated new higher-cost medical technologies in the first few years after introduction to the market. To receive NTAP approval, designated technologies must demonstrate substantial clinical improvement in the diagnosis or treatment of Medicare beneficiaries compared to existing alternatives. Starting October 1, 2025, eligible procedures involving the use of GRAFAPEX™ will be eligible for additional reimbursement through the NTAP program. Cases involving the use of GRAFAPEX™ that are eligible for NTAP will be identified by ICD-10-PCS codes XW03388 or XW04388 and will benefit from a maximum NTAP of $21,411 for CMS's fiscal year 2026. The GRAFAPEX™ approval was one of only five approvals for CMS's fiscal year 2026 under the new technology add-on payment traditional pathway, out of the 13 applications considered by CMS. Medexus achieved $3.0 million of product-level net revenue from GRAFAPEX in fiscal Q1 2026, including a $1.0 million benefit from end-of-quarter wholesaler purchases in anticipation of future hospital demand, relative to the $3.0 million of GRAFAPEX personnel and infrastructure investments discussed below. Medexus expects that product-level net revenue from GRAFAPEX in fiscal Q2 2026 will be $3.0 million to $3.5 million, taking into account the wholesaler purchasing patterns observed to date and expected seasonality attributable to a lower frequency of procedures scheduled during summer months. Based on product-level performance to date, Medexus expects that GRAFAPEX will be accretive to quarterly operating cash flows by fiscal Q3 2026 (calendar Q4 2025). In July 2025, the current US administration announced a 15% tariff on imports of pharmaceutical products from the EU (July 2025 pharmaceutical tariffs). Based on the Company's preliminary assessment, which remains ongoing, the July 2025 pharmaceutical tariffs will apply to the Company's imports of GRAFAPEX at the announced rate of 15%. Medexus does not currently expect the impact of these tariffs on product-level performance to be material. Trecondyv (Canada): Unit demand for Trecondyv remained strong during the 12-month period ended June 30, 2025, which is reflected in the unit demand growth of 38% over the trailing 12-month period ended June 30, 2025. (Source: Hospitals Direct Sales Data, MAT June 2025.) This strong performance reflects successful execution of the Company's initiatives since its September 2021 commercial launch, but does not yet include the full effect of the successful November 2024 completion of the negotiation process with the pan-Canadian Pharmaceutical Alliance seeking to make Trecondyv accessible to publicly funded drug programs and patients in Canada and any subsequent decisions by participating government organizations on public reimbursement of Trecondyv for their regions and jurisdictions. For example, Medexus completed listing agreements for public reimbursement of Trecondyv with the provincial governments of Ontario and British Columbia in fiscal Q4 2025 and with the provincial governments of Quebec and Manitoba in fiscal Q1 2026. Medexus sees these developments in the Canadian market as important indicators of the product's prospects and potential in both the Canadian and US markets. IXINITY (US): Unit demand in the United States decreased by 1% over the trailing 12-month period ended June 30, 2025. (Source: customer-reported dispensing data.) Medexus expects that 12-month trailing unit demand will remain relatively stable, with only slight continuing decreases, in the near term. See also "Selected Financial Information-Note regarding period-to-period variations" and "Discussion of Operations-Net revenue". This performance reflects the success of the Company's efforts to maintain existing demand, despite a reduced allocation of sales force resources to IXINITY since January 2024. Medexus's investments in its IXINITY manufacturing process improvement initiative have generally had a positive impact on batch yield and manufacturing costs over fiscal years 2024 and 2025 and now continuing into fiscal year 2026. Allergy, dermatology, and rheumatology Rupall (Canada): Rupall's market exclusivity, granted by Health Canada, expired in January 2025 and Rupall now faces generic competition in Canada. As a result, unit demand over the six-month period ended June 30, 2025 has decreased 29% when compared to the corresponding prior year period. (Source: IQVIA TSA units - MAT June 2025.) Generic competition will continue to have an adverse impact on net sales of Rupall. Medexus initiated unit-level pricing strategies that resulted in effective unit-level price reductions in fiscal Q4 2025, which are expected to continue through fiscal year 2026 and thereafter. Rasuvo (US): Unit demand for Rasuvo decreased by 5% over the trailing 12-month period ended June 30, 2025. (Source: IQVIA MAT June 2025.) Sustained competition in the US branded methotrexate autoinjector market, among other factors, have and will continue to adversely affect total product-level net revenue. See also "Selected Financial Information-Note regarding period-to-period variations" and "Discussion of Operations-Net revenue". Based on the Company's preliminary assessment, which remains ongoing, the July 2025 pharmaceutical tariffs will apply to the Company's imports of Rasuvo at the announced rate of 15%. Medexus does not currently expect the impact of these tariffs on product-level performance to be material. Metoject (Canada): Unit demand for Metoject decreased by 5% over the trailing 12-month period ended June 30, 2025. (Source: IQVIA - TSA database.) Medexus attributes this decrease in unit demand, which has corresponded with an adverse impact on product-level net revenue, to the continued effects of generic competition, in particular the launch of a second generic product in March 2024. Medexus implemented additional unit-level pricing strategies in April 2024 that resulted in effective unit-level price reductions to defend the product's strong market position, which has contributed to the adverse impact on product-level net revenue. Additional information Medexus's financial statements and management's discussion and analysis for fiscal Q1 2026 are available on Medexus's corporate website at and in the company's corporate filings on SEDAR+ at Conference call details Medexus will host a conference call at 8:00 am Eastern Time on Wednesday, August 13, 2025 to discuss Medexus's results for fiscal Q1 2026. To participate in the call, please dial the following numbers: 888-506-0062 (toll-free) for Canadian and U.S. callers +1 973-528-0011 for international callers Access code: 284388 A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link: A replay of the call will be available approximately one hour following the end of the call through Wednesday, August 20, 2025. To access the replay, please dial the following numbers - 877-481-4010 for Canadian and U.S. callers +1 919-882-2331 for international callers Conference ID: 52801 A replay of the webcast will be available on the Investors section of Medexus's corporate website until Thursday, August 13, 2026. About Medexus Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology-oncology and allergy, dermatology, and rheumatology. For more information about Medexus and its product portfolio, please see the company's corporate website at and its filings on SEDAR+ at Preliminary estimates The expected results discussed in this news release (which are distinct from the historical results included in Medexus's financial statements and discussed in this news release) are preliminary estimates only and have not been reviewed or audited by the Company's auditors. Expected results discussed in this news release include preliminary estimates of product-level net revenue generated from GRAFAPEX in fiscal Q2 2026. All such figures are based on information currently available to Medexus management and are subject to change and adjustment as Medexus's financial results for fiscal Q2 2026 are finalized. Accordingly, final reported results may differ, and may differ materially, from these preliminary estimates, and investors therefore should not place undue reliance on any such preliminary estimates. All such preliminary estimates constitute forward-looking information within the meaning of applicable securities laws, are based on a number of assumptions, and are subject to a number of risks and uncertainties. For more information, see "Forward-looking statements". Forward-looking statements Certain statements in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "budget", "potential", "targets", "could", "estimates", "expects", "forecasts", "goals", "intends", "may", "might", "objective", "outlook", "plans", "projects", "schedule", "should", "will", "would", "prospects", and "vision", or similar words, phrases, or expressions, are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, information contained in statements regarding any of the following: Medexus's business strategy, outlook, and other expectations and plans regarding financial or operational performance, including those specific to GRAFAPEX™ (treosulfan) for Injection, in particular in light of investments in the recent commercial launch of GRAFAPEX; future growth, revenues, and expenses, including in respect of the commercialization of GRAFAPEX and Medexus's other leading products, and including product-level performance in respect of same, and including, among others, the potential impact of the July 2025 tariff on imports of pharmaceutical products from the EU announced by the current US administration; the expected benefit to Trecondyv® (treosulfan for injection) of the listing agreements for public reimbursement with provincial health services, including in respect of product-level net revenue, and anticipated effects of Medexus's unit-level pricing strategies. The forward-looking statements and information included in this news release are based on Medexus's current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. In particular, and without limiting the generality of the foregoing, Medexus's estimate of product-level net revenue from commercialization of GRAFAPEX is based on a number of such factors and assumptions as most recently described in Medexus's most recent management's discussion and analysis, and including the Company's planned commercial, market access, and medical strategies, the success of which will depend in part on the US regulatory landscape and related dynamics, including potential future changes to each, and can introduce and affect exposure to commercial, legal, and regulatory risk. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise. Protected names and marks This news release contains references to trademarks and other protected names and marks, including those belonging to other companies, persons, or entities. Solely for convenience, trademarks and other protected names and marks referred to in this news release may appear without the "®", "™", or other similar symbols. Each such reference should be read as though it appears with the relevant symbol. Any such references are not intended to indicate, in any way, that the holder or holders will not assert those rights to the fullest extent under applicable law. Non-GAAP measures Company management uses, and this news release refers to, financial measures that are not recognized under IFRS and do not have a standard meaning prescribed by generally accepted accounting principles (GAAP) in accordance with IFRS or other financial or accounting authorities (non-GAAP measures). These non-GAAP measures may include "non-GAAP financial measures", "non-GAAP ratios", and "supplementary financial measures" (each defined in National Instrument 52-112, Non-GAAP and Other Financial Measures Disclosure). Medexus's method for calculating these measures may differ from methods used by other companies and therefore these measures are unlikely to be comparable to similarly-designated measures used or presented by other companies. In particular, management uses Adjusted EBITDA, Adjusted EBITDA Margin (Adjusted EBITDA divided by net revenue, expressed as a percentage), Adjusted Gross Profit (Loss) (gross profit (loss) before amortization of intangible assets), product-level Adjusted Gross Profit (Loss), Adjusted Gross Margin (Adjusted Gross Profit (Loss) divided by net revenue, expressed as a percentage), product-level Adjusted Gross Margin, and product-level net revenue as measures of Medexus's performance. EBITDA (earnings before interest, taxes, depreciation, and amortization), Adjusted EBITDA, Adjusted Gross Profit (Loss), and product-level Adjusted Gross Profit (Loss) are non-GAAP financial measures; Adjusted EBITDA Margin, Adjusted Gross Margin, and product-level Adjusted Gross Margin are non-GAAP ratios; and product-level net revenue and gross margin (gross profit (loss) divided by net revenue, expressed as a percentage) are supplementary financial measures. An explanation and discussion of each of these non-GAAP measures, including their limitations, is set out under the heading "Preliminary Notes-Non-GAAP measures" in Medexus's most recent management's discussion and analysis, and is hereby incorporated by reference. A reconciliation of Adjusted EBITDA to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted EBITDA to Net Income (Loss)" below. A reconciliation of Adjusted Gross Margin and product-level Adjusted Gross Margin to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted Gross Profit (Loss) and Adjusted Gross Margin" below. The following tables are derived from and should be read together with Medexus's consolidated financial statements for the three-month period ended June 30, 2025. The supplementary disclosure is intended to more fully explain disclosures related to Adjusted EBITDA, Adjusted Gross Margin, and product-level Adjusted Gross Margin, and provides additional information related to Medexus's operating performance. However, Medexus's non-GAAP measures have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of Medexus's financial information as reported under IFRS. Reconciliation of Adjusted EBITDA to Net Income (Loss) Three-month periods ended June 30, (Amounts in $ '000s except percentages) 2025 2024 Net income $ 516 $ 1,957 Add back: Depreciation and amortization (property, equipment, product licenses) 2,426 1,410 Financing costs 1,406 2,031 Income tax expense (recovery) 99 (57) EBITDA 4,447 5,341 Add back: Share-based compensation 167 362 Termination benefits - 356 Business combinations payable - unrealized gain on change in fair value (182) - Foreign exchange (gain) loss (581) 43 Gain on disposal of assets (408) - Adjusted EBITDA 3,443 6,102 Adjusted EBITDA Margin 14.0% 22.4% Reconciliation of Adjusted Gross Profit (Loss) and Adjusted Gross Margin Company Three-month periods ended June 30, (Amounts in $ '000s except percentages) 2025 2024 Net revenue 24,615 27,283 Cost of sales 10,841 12,448 Gross profit 13,774 14,835 Gross margin 56.0% 54.4% Add back: Amortization of product licenses 2,356 1,351 Adjusted Gross Profit 16,130 16,186 Adjusted Gross Margin 65.5% 59.3% GRAFAPEX Three-month periods ended June 30, (Amounts in $ '000s except percentages) 2025 2024 Product-level net revenue 3,013 n/a Product-level cost of sales (1,518) n/a Product-level gross profit 1,495 n/a Product-level gross margin 49.6% n/a Add back: Product-level amortization of product licenses 1,071 n/a Product-level Adjusted Gross Profit 2,566 n/a Product-level Adjusted Gross Margin 85.2% n/a To view the source version of this press release, please visit
Yahoo
2 days ago
- Business
- Yahoo
Medexus Announces Fiscal Q1 2026 Results, Including Positive Results from US Launch of GRAFAPEX (treosulfan) for Injection
Fiscal Q1 2026 net revenue of $24.6 million, net income of $0.5 million, operating income of $0.9 million, and Adjusted EBITDA* of $3.4 million $3.0 million of product-level net revenue from GRAFAPEX in fiscal Q1 2026, relative to $3.0 million of personnel and infrastructure investments, further supporting Medexus's confidence in the product's potential Management to host conference call at 8:00 AM Eastern time on Wednesday, August 13, 2025 Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - August 12, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company's first fiscal quarter ended June 30, 2025 (the company's fiscal Q1 2026). All dollar amounts in this press release are in United States dollars unless specified otherwise. Key business update Medexus is currently focused on delivering strong performance from GRAFAPEX. March 2025 was the first full month, and fiscal Q1 2026 was the first full fiscal quarter, in which Medexus recognized product-level net revenue from GRAFAPEX, which totaled $3.0 million for fiscal Q1 2026, relative to $3.0 million of GRAFAPEX personnel and infrastructure investments. Medexus also remains focused on delivering strong overall performance across the company's portfolio of products in both the United States and Canada. Medexus has seen a positive market response to GRAFAPEX to date, with progress consistent with Company expectations: As of June 30, 2025, nine large commercial payers, together covering an estimated 48 million patient lives, and 14 individual healthcare institutions, representing 8% of the 180 transplant centers in the United States, have made positive formulary inclusion determinations, a promising indicator of the product's commercial potential. An additional 29 commercial payers have added GRAFAPEX on their "prior authorization" lists. Wholesaler data as of June 30, 2025 shows that 36 of the 180 transplant centers, representing an estimated 24% of total allo-HSCT procedures performed in the United States annually (Source: Allogeneic HSCT in HRSA 2016-2020; Health Resources and Services Administration), have already ordered GRAFAPEX for procedures in their institutions. Medexus expects that product-level net revenue from GRAFAPEX in fiscal Q2 2026 will be $3.0 million to $3.5 million, taking into account the wholesaler purchasing patterns observed to date and expected seasonality attributable to a lower frequency of procedures scheduled during summer months. Based on product-level performance to date, Medexus expects that GRAFAPEX will be accretive to quarterly operating cash flows by fiscal Q3 2026 (calendar Q4 2025). Medexus also continues to expect that the annual product-level Adjusted Gross Margin* of GRAFAPEX will ultimately be approximately 80%, although, as demonstrated by product-level Adjusted Gross Margin* for fiscal Q1 2026, product level Adjusted Gross Margin* will be slightly higher in the initial months or quarters after commercial launch primarily due to the evolving reimbursement and tariff dynamics for the product (including as discussed below). "The strong initial performance of GRAFAPEX™ is particularly important as other products in our portfolio shift to the later stages of their product life cycle," commented Ken d'Entremont, Chief Executive Officer of Medexus. "For instance, Rupall's revenues have experienced erosion after the loss of its exclusivity period in January 2025. Over time, we expect product-level performance of GRAFAPEX™ to significantly outweigh the relatively smaller impact of this decline in Rupall product-level performance in this transitional period. We design this portfolio approach to stay agile, resilient, and ultimately successful over the long term." Medexus views product performance to date, and the response from the market and the attention to treosulfan from the medical and scientific community, as consistent with the Company's confidence that GRAFAPEX will make a substantial contribution to allo-HSCT in the United States, and also solidify Medexus's leadership position in this therapeutic field. Financial highlights Key financial highlights for fiscal Q1 2026 include the following: Net revenue of $24.6 million, a decrease of $2.7 million, or 9.9%, compared to $27.3 million for fiscal Q1 2025. The $2.7 million year-over-year net revenue decrease was primarily due to reduced net sales of Rupall (due to significant generic competition, resulting in lower unit demand, and the effects of the resulting effective unit-level price reductions) and Gleolan in the United States (due to the March 2025 termination of the US Gleolan Agreement), partially offset by $3.0 million of product-level net revenue from GRAFAPEX in fiscal Q1 2026. Adjusted EBITDA* of $3.4 million, a decrease of $2.7 million, or 44.3%, compared to $6.1 million for fiscal Q1 2025. The $2.7 million year-over-year Adjusted EBITDA* decrease was primarily due to the effect of significant generic competition on Rupall. Operating income of $0.9 million, a decrease of $3.1 million, or 77.5%, compared to $4.0 million for fiscal Q1 2025. Net income of $0.5 million, a decrease of $1.5 million compared to net income of $2.0 million for fiscal Q1 2025. Available liquidity of $9.3 million (June 30, 2025), consisting of cash and cash equivalents, compared to $24.0 million (March 31, 2025). The primary factor in this net decrease in cash was a payment of $15.5 million that Medexus made in June 2025 under the terms of a June 2025 amendment to the Company's credit agreement. Cash provided by operating activities of $3.9 million, a decrease of $4.3 million compared to $8.2 million for fiscal Q1 2025. * Refer to "Non-GAAP measures" at the end of this press release for information about non-GAAP measures and related items, including Adjusted EBITDA and Adjusted Gross Margin. "We are very pleased with the successful launch of GRAFAPEX™ in the United States," commented Ken d'Entremont, Chief Executive Officer of Medexus. "We believe this sequential quarter-over-quarter momentum we have seen will continue to build as GRAFAPEX™ is added to the formularies of additional key institutions and insurers, expanding patient access and driving further adoption. The positive initial response we have seen to date, including full results from the first full fiscal quarter of GRAFAPEX™ commercial availability, supports our expectation that GRAFAPEX™ will be accretive to quarterly operating cash flows by calendar Q4 2025, which is our fiscal Q3 2026." Brendon Buschman, Chief Financial Officer of Medexus, added: "In addition to the successful progress on GRAFAPEX™ commercialization, we achieved $0.5 million of positive net income for fiscal Q1 2026, and a healthy $3.4 million of Adjusted EBITDA* from $24.6 million of net revenue. We realized gross margin of 56.0% and Adjusted Gross Margin* of 65.5% for fiscal Q1 2026, compared to last year's 54.4% and 59.3%, respectively, demonstrating meaningful year-over-year improvement relative to steady gross profits of $13.8 million and $14.8 million and Adjusted Gross Profits* of $16.1 million and 16.2 million, respectively. These strong results provided $3.9 million in cash flow from operating activities, which we have used in part to continue to repay principal and interest under our term loan, substantially reducing total debt under our credit facilities by $15.5 million in fiscal Q1 2026 - meaning that total debt now sits at a combined $22.0 million as of June 30, 2025, with remaining scheduled principal payments of $1.1 million in each of September and December 2025." Mr Buschman concluded: "We have entered fiscal year 2026 with strong momentum and expect continued quarter-over-quarter performance as our commercialization efforts for GRAFAPEX™ advance. Overall, we continue to execute with discipline and focus as we position Medexus for the opportunities ahead." Operational highlights Leading products Hematology and hemato-oncology GRAFAPEX (US): Medexus has seen a positive market response to GRAFAPEX since the US commercial launch of the product in February 2025. Based on internal estimates and research, and the preliminary market response to GRAFAPEX, Medexus continues to expect that annual product-level net revenue from GRAFAPEX will exceed US$100 million within five years after commercial launch, with the specific nature and level of success of Medexus's commercialization initiatives in support of GRAFAPEX, among other factors, determining the extent to which the Company realizes this potential. In August 2025, the US Centers for Medicare & Medicaid Services (CMS) approved New Technology Add-On Payment (NTAP) reimbursement for eligible cases involving the use of GRAFAPEX for CMS's fiscal year 2026, which runs from October 1, 2025 to September 30, 2026. The NTAP program is designed to provide temporary supplemental reimbursement to institutions that use designated new higher-cost medical technologies in the first few years after introduction to the market. To receive NTAP approval, designated technologies must demonstrate substantial clinical improvement in the diagnosis or treatment of Medicare beneficiaries compared to existing alternatives. Starting October 1, 2025, eligible procedures involving the use of GRAFAPEX™ will be eligible for additional reimbursement through the NTAP program. Cases involving the use of GRAFAPEX™ that are eligible for NTAP will be identified by ICD-10-PCS codes XW03388 or XW04388 and will benefit from a maximum NTAP of $21,411 for CMS's fiscal year 2026. The GRAFAPEX™ approval was one of only five approvals for CMS's fiscal year 2026 under the new technology add-on payment traditional pathway, out of the 13 applications considered by CMS. Medexus achieved $3.0 million of product-level net revenue from GRAFAPEX in fiscal Q1 2026, including a $1.0 million benefit from end-of-quarter wholesaler purchases in anticipation of future hospital demand, relative to the $3.0 million of GRAFAPEX personnel and infrastructure investments discussed below. Medexus expects that product-level net revenue from GRAFAPEX in fiscal Q2 2026 will be $3.0 million to $3.5 million, taking into account the wholesaler purchasing patterns observed to date and expected seasonality attributable to a lower frequency of procedures scheduled during summer months. Based on product-level performance to date, Medexus expects that GRAFAPEX will be accretive to quarterly operating cash flows by fiscal Q3 2026 (calendar Q4 2025). In July 2025, the current US administration announced a 15% tariff on imports of pharmaceutical products from the EU (July 2025 pharmaceutical tariffs). Based on the Company's preliminary assessment, which remains ongoing, the July 2025 pharmaceutical tariffs will apply to the Company's imports of GRAFAPEX at the announced rate of 15%. Medexus does not currently expect the impact of these tariffs on product-level performance to be material. Trecondyv (Canada): Unit demand for Trecondyv remained strong during the 12-month period ended June 30, 2025, which is reflected in the unit demand growth of 38% over the trailing 12-month period ended June 30, 2025. (Source: Hospitals Direct Sales Data, MAT June 2025.) This strong performance reflects successful execution of the Company's initiatives since its September 2021 commercial launch, but does not yet include the full effect of the successful November 2024 completion of the negotiation process with the pan-Canadian Pharmaceutical Alliance seeking to make Trecondyv accessible to publicly funded drug programs and patients in Canada and any subsequent decisions by participating government organizations on public reimbursement of Trecondyv for their regions and jurisdictions. For example, Medexus completed listing agreements for public reimbursement of Trecondyv with the provincial governments of Ontario and British Columbia in fiscal Q4 2025 and with the provincial governments of Quebec and Manitoba in fiscal Q1 2026. Medexus sees these developments in the Canadian market as important indicators of the product's prospects and potential in both the Canadian and US markets. IXINITY (US): Unit demand in the United States decreased by 1% over the trailing 12-month period ended June 30, 2025. (Source: customer-reported dispensing data.) Medexus expects that 12-month trailing unit demand will remain relatively stable, with only slight continuing decreases, in the near term. See also "Selected Financial Information-Note regarding period-to-period variations" and "Discussion of Operations-Net revenue". This performance reflects the success of the Company's efforts to maintain existing demand, despite a reduced allocation of sales force resources to IXINITY since January 2024. Medexus's investments in its IXINITY manufacturing process improvement initiative have generally had a positive impact on batch yield and manufacturing costs over fiscal years 2024 and 2025 and now continuing into fiscal year 2026. Allergy, dermatology, and rheumatology Rupall (Canada): Rupall's market exclusivity, granted by Health Canada, expired in January 2025 and Rupall now faces generic competition in Canada. As a result, unit demand over the six-month period ended June 30, 2025 has decreased 29% when compared to the corresponding prior year period. (Source: IQVIA TSA units - MAT June 2025.) Generic competition will continue to have an adverse impact on net sales of Rupall. Medexus initiated unit-level pricing strategies that resulted in effective unit-level price reductions in fiscal Q4 2025, which are expected to continue through fiscal year 2026 and thereafter. Rasuvo (US): Unit demand for Rasuvo decreased by 5% over the trailing 12-month period ended June 30, 2025. (Source: IQVIA MAT June 2025.) Sustained competition in the US branded methotrexate autoinjector market, among other factors, have and will continue to adversely affect total product-level net revenue. See also "Selected Financial Information-Note regarding period-to-period variations" and "Discussion of Operations-Net revenue". Based on the Company's preliminary assessment, which remains ongoing, the July 2025 pharmaceutical tariffs will apply to the Company's imports of Rasuvo at the announced rate of 15%. Medexus does not currently expect the impact of these tariffs on product-level performance to be material. Metoject (Canada): Unit demand for Metoject decreased by 5% over the trailing 12-month period ended June 30, 2025. (Source: IQVIA - TSA database.) Medexus attributes this decrease in unit demand, which has corresponded with an adverse impact on product-level net revenue, to the continued effects of generic competition, in particular the launch of a second generic product in March 2024. Medexus implemented additional unit-level pricing strategies in April 2024 that resulted in effective unit-level price reductions to defend the product's strong market position, which has contributed to the adverse impact on product-level net revenue. Additional information Medexus's financial statements and management's discussion and analysis for fiscal Q1 2026 are available on Medexus's corporate website at and in the company's corporate filings on SEDAR+ at Conference call details Medexus will host a conference call at 8:00 am Eastern Time on Wednesday, August 13, 2025 to discuss Medexus's results for fiscal Q1 2026. To participate in the call, please dial the following numbers: 888-506-0062 (toll-free) for Canadian and U.S. callers+1 973-528-0011 for international callers Access code: 284388 A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link: A replay of the call will be available approximately one hour following the end of the call through Wednesday, August 20, 2025. To access the replay, please dial the following numbers - 877-481-4010 for Canadian and U.S. callers+1 919-882-2331 for international callers Conference ID: 52801 A replay of the webcast will be available on the Investors section of Medexus's corporate website until Thursday, August 13, 2026. About Medexus Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology-oncology and allergy, dermatology, and rheumatology. For more information about Medexus and its product portfolio, please see the company's corporate website at and its filings on SEDAR+ at Contacts Ken d'Entremont | CEO, Medexus PharmaceuticalsTel: 905-676-0003 | Email: Brendon Buschman | CFO, Medexus PharmaceuticalsTel: 416-577-6216 | Email: Victoria Rutherford | Adelaide CapitalTel: 480-625-5772 | Email: victoria@ Preliminary estimates The expected results discussed in this news release (which are distinct from the historical results included in Medexus's financial statements and discussed in this news release) are preliminary estimates only and have not been reviewed or audited by the Company's auditors. Expected results discussed in this news release include preliminary estimates of product-level net revenue generated from GRAFAPEX in fiscal Q2 2026. All such figures are based on information currently available to Medexus management and are subject to change and adjustment as Medexus's financial results for fiscal Q2 2026 are finalized. Accordingly, final reported results may differ, and may differ materially, from these preliminary estimates, and investors therefore should not place undue reliance on any such preliminary estimates. All such preliminary estimates constitute forward-looking information within the meaning of applicable securities laws, are based on a number of assumptions, and are subject to a number of risks and uncertainties. For more information, see "Forward-looking statements". Forward-looking statements Certain statements in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "budget", "potential", "targets", "could", "estimates", "expects", "forecasts", "goals", "intends", "may", "might", "objective", "outlook", "plans", "projects", "schedule", "should", "will", "would", "prospects", and "vision", or similar words, phrases, or expressions, are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, information contained in statements regarding any of the following: Medexus's business strategy, outlook, and other expectations and plans regarding financial or operational performance, including those specific to GRAFAPEX™ (treosulfan) for Injection, in particular in light of investments in the recent commercial launch of GRAFAPEX; future growth, revenues, and expenses, including in respect of the commercialization of GRAFAPEX and Medexus's other leading products, and including product-level performance in respect of same, and including, among others, the potential impact of the July 2025 tariff on imports of pharmaceutical products from the EU announced by the current US administration; the expected benefit to Trecondyv® (treosulfan for injection) of the listing agreements for public reimbursement with provincial health services, including in respect of product-level net revenue, and anticipated effects of Medexus's unit-level pricing strategies. The forward-looking statements and information included in this news release are based on Medexus's current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. In particular, and without limiting the generality of the foregoing, Medexus's estimate of product-level net revenue from commercialization of GRAFAPEX is based on a number of such factors and assumptions as most recently described in Medexus's most recent management's discussion and analysis, and including the Company's planned commercial, market access, and medical strategies, the success of which will depend in part on the US regulatory landscape and related dynamics, including potential future changes to each, and can introduce and affect exposure to commercial, legal, and regulatory risk. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise. Protected names and marks This news release contains references to trademarks and other protected names and marks, including those belonging to other companies, persons, or entities. Solely for convenience, trademarks and other protected names and marks referred to in this news release may appear without the "®", "™", or other similar symbols. Each such reference should be read as though it appears with the relevant symbol. Any such references are not intended to indicate, in any way, that the holder or holders will not assert those rights to the fullest extent under applicable law. Non-GAAP measures Company management uses, and this news release refers to, financial measures that are not recognized under IFRS and do not have a standard meaning prescribed by generally accepted accounting principles (GAAP) in accordance with IFRS or other financial or accounting authorities (non-GAAP measures). These non-GAAP measures may include "non-GAAP financial measures", "non-GAAP ratios", and "supplementary financial measures" (each defined in National Instrument 52-112, Non-GAAP and Other Financial Measures Disclosure). Medexus's method for calculating these measures may differ from methods used by other companies and therefore these measures are unlikely to be comparable to similarly-designated measures used or presented by other companies. In particular, management uses Adjusted EBITDA, Adjusted EBITDA Margin (Adjusted EBITDA divided by net revenue, expressed as a percentage), Adjusted Gross Profit (Loss) (gross profit (loss) before amortization of intangible assets), product-level Adjusted Gross Profit (Loss), Adjusted Gross Margin (Adjusted Gross Profit (Loss) divided by net revenue, expressed as a percentage), product-level Adjusted Gross Margin, and product-level net revenue as measures of Medexus's performance. EBITDA (earnings before interest, taxes, depreciation, and amortization), Adjusted EBITDA, Adjusted Gross Profit (Loss), and product-level Adjusted Gross Profit (Loss) are non-GAAP financial measures; Adjusted EBITDA Margin, Adjusted Gross Margin, and product-level Adjusted Gross Margin are non-GAAP ratios; and product-level net revenue and gross margin (gross profit (loss) divided by net revenue, expressed as a percentage) are supplementary financial measures. An explanation and discussion of each of these non-GAAP measures, including their limitations, is set out under the heading "Preliminary Notes-Non-GAAP measures" in Medexus's most recent management's discussion and analysis, and is hereby incorporated by reference. A reconciliation of Adjusted EBITDA to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted EBITDA to Net Income (Loss)" below. A reconciliation of Adjusted Gross Margin and product-level Adjusted Gross Margin to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted Gross Profit (Loss) and Adjusted Gross Margin" below. The following tables are derived from and should be read together with Medexus's consolidated financial statements for the three-month period ended June 30, 2025. The supplementary disclosure is intended to more fully explain disclosures related to Adjusted EBITDA, Adjusted Gross Margin, and product-level Adjusted Gross Margin, and provides additional information related to Medexus's operating performance. However, Medexus's non-GAAP measures have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of Medexus's financial information as reported under IFRS. Reconciliation of Adjusted EBITDA to Net Income (Loss) Three-month periods ended June 30,(Amounts in $ '000s except percentages)2025 2024Net income $ 516$ 1,957Add back: Depreciation and amortization (property, equipment, product licenses)2,426 1,410Financing costs1,406 2,031Income tax expense (recovery)99 (57 ) EBITDA4,447 5,341Add back: Share-based compensation167 362Termination benefits- 356Business combinations payable - unrealized gain on change in fair value(182 )-Foreign exchange (gain) loss(581 )43Gain on disposal of assets(408 )-Adjusted EBITDA3,443 6,102Adjusted EBITDA Margin14.0% 22.4% Reconciliation of Adjusted Gross Profit (Loss) and Adjusted Gross MarginCompany Three-month periods ended June 30,(Amounts in $ '000s except percentages)2025 2024Net revenue24,615 27,283Cost of sales10,841 12,448Gross profit13,774 14,835Gross margin56.0% 54.4%Add back: Amortization of product licenses2,356 1,351Adjusted Gross Profit16,130 16,186Adjusted Gross Margin65.5% 59.3% GRAFAPEX Three-month periods ended June 30,(Amounts in $ '000s except percentages)2025 2024Product-level net revenue3,013 n/aProduct-level cost of sales(1,518 )n/aProduct-level gross profit1,495 n/aProduct-level gross margin49.6% n/aAdd back: Product-level amortization of product licenses1,071 n/aProduct-level Adjusted Gross Profit2,566 n/aProduct-level Adjusted Gross Margin85.2% n/a To view the source version of this press release, please visit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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05-08-2025
- Business
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Medexus Schedules First Fiscal Quarter 2026 Conference Call
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - August 5, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) plans to host a conference call at 8:00 am Eastern Time on Wednesday, August 13, 2025 to discuss Medexus's results for its first fiscal quarter ended June 30, 2025. Medexus expects to file its financial statements and MD&A after markets close on August 12, 2025. To participate in the call, please dial the following numbers: 888-506-0062 (toll-free) for Canadian and U.S. callers+1 973-528-0011 for international callers Access code: 284388 A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link: A replay of the call will be available approximately one hour following the end of the call through Wednesday, August 20, 2025. To access the replay, please dial the following numbers — 877-481-4010 for Canadian and U.S. callers+1 919-882-2331 for international callers Conference ID: 52801 A replay of the webcast will be available on the Investors section of Medexus's corporate website until Thursday, August 13, 2026. Company management will be available to discuss the company's commercialization activities at Cannacord Genuity's 45th Annual Growth Conference in Boston from August 12 to 14, 2025 and the LD Micro Main Event in San Diego from October 19 to 21, 2025. Details regarding Medexus's participation will be available on the Investors-News & Events section of Medexus's corporate website. About Medexus Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology and hematology-oncology and allergy, dermatology, and rheumatology. For more information about Medexus and its product portfolio, please see the company's corporate website at and its filings on SEDAR+ at Contacts Ken d'Entremont | CEO, Medexus PharmaceuticalsTel: 905-676-0003 | Email: Brendon Buschman | CFO, Medexus PharmaceuticalsTel: 416-577-6216 | Email: Forward-looking statements Certain statements made in this news release contain forward-looking information within the meaning of applicable securities laws (forward-looking statements). The words "anticipates", "believes", "expects", "will", "plans", "potential", and similar words, phrases, or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise. To view the source version of this press release, please visit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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25-06-2025
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Medexus Announces Strong Fiscal Year 2025 Results, Including Initial Results from Launch of GRAFAPEX (treosulfan) for Injection in the United States
Fiscal year 2025 revenue of $108.3 million, record net income of $2.2 million, operating income of $8.2 million, and record Adjusted EBITDA* of $20.2 million US commercial launch of GRAFAPEX™ executed in February 2025, following swiftly on the FDA's approval in January 2025, with initial indicators supporting Medexus's confidence in the product's potential Management to host conference call at 8:00 AM Eastern time on Thursday, June 26, 2025 Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - June 25, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company's fourth fiscal quarter and fiscal year ended March 31, 2025 (the company's fiscal Q4 2025 and fiscal year 2025). All dollar amounts in this press release are in United States dollars unless specified otherwise. Key business update Medexus executed a commercial launch of GRAFAPEX™ (treosulfan) for Injection with product commercially available in the United States in February 2025. The launch, which was originally expected to occur by April 2025, followed swiftly on the FDA's approval of the product in January 2025, allowing Medexus to begin generating product-level revenue in fiscal Q4 2025. Based on internal estimates and research, Medexus continues to expect that annual product-level revenue from GRAFAPEX will exceed US$100 million within five years after commercial launch. Medexus has seen a positive market response to GRAFAPEX to date, with progress consistent with Company expectations: Four large commercial payers, together covering an estimated 34 million patient lives, and 12 individual healthcare institutions, representing 7% of the 180 transplant centers in the United States, have made positive formulary inclusion determinations, a promising indicator of the product's commercial potential. An additional 15 commercial payers have added GRAFAPEX on their "prior authorization" lists. Wholesaler data shows that 34 of the 180 transplant centers have already ordered GRAFAPEX for procedures in their institutions. Medexus achieved $0.6 million of product-level revenue from GRAFAPEX in fiscal Q4 2025, relative to $2.7 million of GRAFAPEX personnel and infrastructure investments in the quarter, and preliminary estimates indicate that it has already generated over $2.5 million of product-level revenue in fiscal Q1 2026. Medexus continues to expect that GRAFAPEX will be accretive to quarterly operating cash flows by fiscal Q4 2026 (calendar Q1 2026), although the Company continues to assess the strong market response and performance of key indicators for any updates to this expectation. Medexus continues to expect that the annual product-level Adjusted Gross Margin* of GRAFAPEX will ultimately be approximately 80%, although, as a preliminary estimate, product-level Adjusted Gross Margin* will be slightly higher in the initial months after commercial launch primarily due to the evolving reimbursement dynamics for the product. Financial highlights Key financial highlights for financial year 2025 include the following: Net revenue of $108.3 million, a decrease of $4.8 million, or 4.2%, compared to $113.1 million for fiscal year 2024. The $4.8 million year-over-year net revenue decrease was primarily due to reduced net sales of Rasuvo (largely due to reductions in non-statutory discounts offered to customers, together with effective unit-level price reductions) in fiscal year 2025 and sustained declines in net sales of IXINITY since fiscal Q3 2024, partially offset by year-over-year increases in net sales of Rupall (in Canada) and Gleolan (in both the United States and Canada). In addition, Medexus achieved $0.6 million of product-level revenue from GRAFAPEX in fiscal Q4 2025. Net revenue of $24.8 million for fiscal Q4 2025, a decrease of $1.2 million, or 4.6%, compared to $26.0 million for fiscal Q4 2024. The $1.2 million year-over-year net revenue decrease was primarily due to the timing of customer buying patterns of IXINITY, which had a $2.0 million beneficial impact in fiscal Q3 2025 and a proportionately negative impact in fiscal Q4 2025. The year-over-year decrease was partially offset by $0.6 million of product-level revenue from GRAFAPEX in fiscal Q4 2025. Record Adjusted EBITDA* of $20.2 million, an increase of $0.7 million, or 3.6%, compared to $19.5 million for fiscal year 2024. The $0.7 million year-over-year Adjusted EBITDA* increase was primarily due to the effects of the Company's ongoing financial discipline efforts, partially offset by the GRAFAPEX personnel and infrastructure investments of $5.2 million for fiscal year 2025. Adjusted EBITDA* of $2.3 million for fiscal Q4 2025, a decrease of $2.1 million, or 48.5%, compared to $4.4 million for fiscal Q4 2024. The $2.1 million year-over-year Adjusted EBITDA* decrease was primarily due to the GRAFAPEX personnel and infrastructure investments of $2.7 million in fiscal Q4 2025 as well as higher research and development expenses incurred in connection Company's planned investment in the IXINITY manufacturing process improvement initiative, which has had a positive impact on batch yield and manufacturing costs. Operating income (loss) of $8.2 million for fiscal year 2025 and $(1.2) million for fiscal Q4 2024, a decrease of $2.6 million and $2.0 million compared to $10.8 million for fiscal year 2024 and $0.8 million for fiscal Q4 2024. Record net income (loss) of $2.2 million for fiscal year 2025 and $(0.6) million for fiscal Q4 2024, an increase of $2.4 million compared to net loss of $0.2 million for fiscal year 2024 and a decrease of $1.3 million compared to net income of $0.7 million for fiscal Q4 2024. Available liquidity of $24.0 million (March 31, 2025), consisting of cash and cash equivalents, compared to $5.3 million (March 31, 2024). The primary factor in this net increase in cash was Medexus's completion of an overnight marketed public offering of Common Shares in January 2025. Cash provided by operating activities of $24.0 million for fiscal year 2025 and $2.3 million for fiscal Q4 2025, an increase of $5.3 million and $0.7 million compared to $18.7 million for fiscal year 2024 and $1.6 million fiscal Q4 2024. * Refer to "Non-GAAP measures" at the end of this press release for information about non-GAAP measures and related items, including Adjusted EBITDA and Adjusted Gross Margin. "We are pleased to report a strong fiscal Q4 and fiscal year 2025," commented Ken d'Entremont, Chief Executive Officer of Medexus. "The highlight for this past quarter was, of course, the commercial launch of GRAFAPEX™, which we executed earlier than expected in February 2025 and which will drive the next phase of our growth. To this end, over fiscal year 2025, we increased our investments in personnel and infrastructure to support GRAFAPEX™ and began generating product-level revenue from GRAFAPEX™ in fiscal Q4 2025." Mr d'Entremont continued: "Given our experience in Canada with Trecondyv® (treosulfan for injection), we are very optimistic about the potential of GRAFAPEX™ in the US market. As we have previously mentioned, not only will GRAFAPEX™ make a substantial contribution to allogeneic hematopoietic stem cell transplantation, or allo-HSCT, in the United States, but it also solidifies Medexus's leadership position in this therapeutic field. We anticipate that GRAFAPEX™ will have a meaningful impact on Medexus's net revenue and believe that annual product-level revenue from GRAFAPEX™ has the potential to exceed US$100 million within five years after commercial launch, providing a significant uptick to our growth profile." Brendon Buschman, Chief Financial Officer of Medexus, added: "In addition to the successful launch of GRAFAPEX™, we achieved $2.2 million of positive net income for fiscal year 2025, and a healthy $20.2 million of Adjusted EBITDA* from $108.3 million of net revenue, for an Adjusted EBITDA Margin* of over 18%, inclusive of $0.6 million of product-level revenue, and $5.2 million personnel and infrastructure investments, specific to GRAFAPEX™. These strong results provided $24.0 million in cash flow from operating activities, which we have used in part to continue to repay principal and interest under our BMO term loan, substantially reducing total debt under our BMO credit facilities - which now sits at a combined $37.6 million as of March 31, 2025. We have made further scheduled and unscheduled principal payments totaling $14.9 million on these credit facilities in fiscal Q1 2026, which further deleverages the company, lowers our quarterly principal payments from $3.3 million per quarter to $1.1 million, and meaningfully reduces our interest expense. Mr Buschman continued: "Looking forward to fiscal year 2026, we are in a great position to support our growth strategy while funding with cash on hand the $15 million remaining regulatory milestone that is payable under our GRAFAPEX™ agreement, particularly given the favorable payment terms we negotiated in the fourth amendment we announced in December 2024." "We have made great progress with GRAFAPEX™ since the commercial launch in February," concluded Ken d'Entremont, Medexus's Chief Executive Officer. "The rate of formulary inclusion will be a key driver of GRAFAPEX™ performance over the coming quarters. Product has been sold to 34 unique institutions, and we expect that we will achieve broad formulary coverage for GRAFAPEX™ as we continue our commercialization efforts. This positive initial response supports our expectation that GRAFAPEX™ will be accretive to quarterly operating cash flows by fiscal Q4 2026." Operational highlights Leading products Hematology-oncology GRAFAPEX (US): In January 2025, Medexus was informed that the FDA approved GRAFAPEX, an alkylating agent, with fludarabine as a preparative regimen for allo-HSCT in adult and pediatric patients one year of age and older with AML or MDS. GRAFAPEX holds Orphan Drug Designation under the Orphan Drug Act, meaning that the product will benefit from a seven-year period of regulatory exclusivity in the FDA-approved indication. Medexus holds exclusive commercial rights to GRAFAPEX in the United States under a February 2021 exclusive license agreement with medac (GRAFAPEX Agreement).In November 2024, Medexus and medac entered into a fourth amendment to the GRAFAPEX Agreement. Among other things, the fourth amendment adjusted the unpaid regulatory milestone payments under the GRAFAPEX Agreement as provided in the fourth amendment. The regulatory milestone amount payable to medac under the fourth amendment upon an FDA approval of GRAFAPEX is based on the language of the product label approved by the FDA. Based on the terms of the approval, including the FDA-approved product label, the parties determined that medac earned a regulatory milestone amount of US$15 million. The regulatory milestone amount is payable in three installments: one-sixth of the total amount (US$2.5 million) is payable by June 30, 2025, one-third of the total amount (US$5 million) is payable by October 1, 2025, and the remaining 50% of the total (US$7.5 million) is payable by January 1, 2026, subject to Medexus's right to temporarily defer the second and/or third such payments on terms described in the fourth amendment. Following the FDA approval of GRAFAPEX in January 2025, Medexus promptly repaid a US$2.5 million credit originally received from medac in September 2021. Trecondyv (Canada): Unit demand for Trecondyv remained strong during the 12-month period ended March 31, 2025, which is reflected in the unit demand growth of 70% over the trailing 12-month period ended March 31, 2025. (Source: Hospitals Direct Sales Data, MAT March 2025.) Medexus estimates that, in calendar year 2023, Trecondyv was used in approximately 56% of allo-HSCT procedures in Canada involving pediatric patients and 10% involving adult patients. (Source: Company data; customized report from the Cell Therapy Transplant Canada registry, 2024.) This strong performance reflects successful execution of the Company's initiatives since its September 2021 commercial launch, but does not yet include the full effect of the successful November 2024 completion of the negotiation process with the pan-Canadian Pharmaceutical Alliance seeking to make Trecondyv accessible to publicly funded drug programs and patients in Canada and any subsequent decisions by participating government organizations on public reimbursement of Trecondyv for their regions and jurisdictions. For example, Medexus completed listing agreements for public reimbursement of Trecondyv with the provincial governments of Ontario, Quebec, and British Columbia, which Medexus expects to benefit product-level revenue beginning in fiscal Q1 2026. Medexus sees these developments in the Canadian market as important indicators of the product's prospects and potential in both the Canadian and US markets. IXINITY (US): Unit demand in the United States increased by 1% over the trailing 12-month period ended March 31, 2025. (Source: customer-reported dispensing data.) Medexus expects that 12-month trailing unit demand will remain relatively stable, with only slight continuing decreases, in the near term. This performance reflects the success of the Company's efforts to maintain existing demand, despite a reduced allocation of sales force resources to IXINITY since January 2024. Medexus's investments in its IXINITY manufacturing process improvement initiative have generally had a positive impact on batch yield and manufacturing costs over fiscal year 2024 and now extending through fiscal year 2025. Allergy, dermatology, and rheumatology Rupall (Canada): Unit demand in Canada remained strong during the 12-month period ended March 31, 2025, which is reflected in the unit demand growth of 14% over the trailing 12-month period ended March 31, 2025. (Source: IQVIA TSA units - MAT March 2025.) This strong performance reflects successful execution of the Company's initiatives to sustain the product's strong performance, together with the product's typical seasonality, particularly in fiscal Q1 2025. Rupall's market exclusivity, granted by Health Canada, expired in January 2025 and, as a result, Rupall will now face generic competition in Canada. Medexus has initiated unit-level pricing strategies that resulted in effective unit-level price reductions in fiscal Q4 2025, which are expected to continue through fiscal year 2026 and thereafter. Rasuvo (US): Unit demand for Rasuvo decreased by 5% over the trailing 12-month period ended March 31, 2025. (Source: IQVIA MAT March 2025.) However, sustained competition in the US branded methotrexate autoinjector market, and statutory discounts and rebates for Rasuvo under government-sponsored programs, have and will continue to adversely affect total product-level revenue. During fiscal year 2025, Medexus largely eliminated investments in non-statutory discounts offered to large customers. Metoject (Canada): Unit demand for Metoject increased by 6% over the trailing 12-month period ended March 31, 2025 in spite of the direct and indirect effects of sustained generic competition. (Source: IQVIA - TSA database.) Medexus has implemented unit-level pricing strategies to defend the product's strong market position, which has adversely impacted product-level revenue, particularly following the launch of a second generic product in March 2024. Other highlights Gleolan (US and Canada): Unit demand in the United States grew by 9% over the trailing 12 months ended March 31, 2025. In March 2025, Medexus entered into an agreement with NX Development Corp. (NXDC), the US subsidiary of photonamic GmbH & Co. (photonamic), to terminate the March 2022 license, supply, and distribution agreement between the parties (US Gleolan Agreement) and return to NXDC the US commercialization rights and responsibilities for Gleolan (aminolevulinic acid hydrochloride powder), an optical imaging agent indicated in patients with glioma (suspected WHO Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. The employment of all Medexus personnel who previously supported Gleolan in the United States was likewise terminated in March 2025. In terminating the March 2022 license, supply and distribution agreement, Medexus no longer has the obligation to pay time-based and sales-based milestone amounts that would have been payable in fiscal year 2026 and thereafter, which would have negatively affected Gleolan's product-level contribution to gross continues to commercialize the product in Canada under a separate February 2019 license and supply agreement with photonamic. Unit demand in Canada grew 36% over the trailing 12 months ended March 31, 2025, reflecting continued successful execution of the Company's commercial plan in that market. (Source: Hospitals Direct Sales Data, MAT March 2025). Topical terbinafine (Canada): In January 2025, Health Canada delivered to Medexus a notice of deficiency regarding Medexus's New Drug Submission, or NDS, for terbinafine hydrochloride nail lacquer to treat fungal nail infections that was accepted for review by Health Canada in December 2023 and sought approval for a distinctive once-a week treatment regimen. The notice of deficiency identified concerns and uncertainties associated with the design of the phase 3 trial submitted to support the requested indication and the interpretation of the efficacy results. Medexus remains focused on building its North American allergy and dermatology franchise and, pending a final determination as to regulatory strategy and response to this notice, if any, has redeployed existing resources to support other portfolio products in this therapeutic area, including Rupall and NYDA, pending any launch of additional commercialization opportunities. Medexus is evaluating the most appropriate path for the topical terbinafine product in light of the January 2025 notice of deficiency. However, in light of the notice of deficiency, the Company has recognized an impairment loss of $0.4 million in fiscal year 2025 to reduce the carrying value of the asset to zero, based on the Company's assessment that the product is not currently commercially viable. BMO Credit Agreement: Subsequent to period end, in fiscal Q1 2026, Medexus entered into amendments to its senior secured credit agreement (BMO Credit Agreement) with Bank of Montreal (BMO) as agent and lender. The June 2025 amendment provided for partial principal repayments and adjustments to the amortization schedule under the term facility, adjustments to the availability and drawdown conditions under the revolving facility, and adjustments to the interest rates and financial covenants under the BMO Credit Agreement, among other amendments. Public offering: In January 2025, Medexus completed an overnight marketed public offering of 7,500,000 Common Shares at a price of C$4.00 per Common Share for aggregate gross proceeds to Medexus of C$30 million (or C$28.3 million net proceeds before expenses). The Company initially used a majority of the net proceeds to secure a now-released cash collateral pledge under the BMO credit agreement, and, following the FDA approval of GRAFAPEX in January 2025, promptly repaid a US$2.5 million credit originally received from medac in September 2021. The remaining net proceeds from the offering will be used to pay a portion of the regulatory milestone amounts payable to medac under the GRAFAPEX Agreement and for working capital and general corporate purposes, which may include funding the Company's ongoing business development activities and initiatives. Additional information Medexus's financial statements and management's discussion and analysis for fiscal year 2025 are available on Medexus's corporate website at and in the company's corporate filings on SEDAR+ at Conference call details Medexus will host a conference call at 8:00 am Eastern Time on Thursday, June 26, 2025 to discuss Medexus's results for fiscal year 2025. To participate in the call, please dial the following numbers: 888-506-0062 (toll-free) for Canadian and U.S. callers+1 973-528-0011 for international callers Access code: 266173 A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link: A replay of the call will be available approximately one hour following the end of the call through Thursday, July 3, 2025. To access the replay, please dial the following numbers - 877-481-4010 for Canadian and U.S. callers+1 919-882-2331 for international callers Conference ID: 52642 A replay of the webcast will be available on the Investors section of Medexus's corporate website until Friday, June 26, 2026. About Medexus Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology-oncology and allergy, dermatology, and rheumatology. For more information about Medexus and its product portfolio, please see the company's corporate website at and its filings on SEDAR+ at Contacts Ken d'Entremont | CEO, Medexus PharmaceuticalsTel: 905-676-0003 | Email: Brendon Buschman | CFO, Medexus PharmaceuticalsTel: 416-577-6216 | Email: Victoria Rutherford | Adelaide CapitalTel: 480-625-5772 | Email: victoria@ Preliminary estimates The expected results discussed in this news release are preliminary estimates only and have not been reviewed or audited by the Company's auditors. All such figures are based on information currently available to Medexus management and are subject to change and adjustment as Medexus's financial results for fiscal Q1 2026 are finalized. Accordingly, final reported results may differ, and may differ materially, from these preliminary estimates, and investors therefore should not place undue reliance on any such preliminary estimates. All such preliminary estimates constitute forward-looking information within the meaning of applicable securities laws, are based on a number of assumptions, and are subject to a number of risks and uncertainties. For more information, see "Forward-looking statements" below. Forward-looking statements Certain statements in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "budget", "potential", "targets", "could", "estimates", "expects", "forecasts", "goals", "intends", "may", "might", "objective", "outlook", "plans", "projects", "schedule", "should", "will", "would", "prospects", and "vision", or similar words, phrases, or expressions, are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, information contained in statements regarding any of the following: Medexus's business strategy, outlook, and other expectations and plans regarding financial or operational performance, including those specific to GRAFAPEX™ (treosulfan) for Injection, in particular in light of investments in the recent commercial launch of GRAFAPEX; future growth, revenues, and expenses, including in respect of the commercialization of GRAFAPEX and Medexus's other leading products; the expected benefit to Trecondyv® (treosulfan for injection) of the listing agreements for public reimbursement with provincial health services in Ontario, Quebec, and British Columbia, including in respect of product-level revenue and anticipated effects of Medexus's unit-level pricing strategies. The forward-looking statements and information included in this news release are based on Medexus's current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. In particular, and without limiting the generality of the foregoing, Medexus's estimate of product-level revenue from commercialization of GRAFAPEX is based on a number of such factors and assumptions as most recently described in Medexus's most recent management's discussion and analysis, and including the Company's planned commercial, market access, and medical strategies, the success of which will depend in part on the US regulatory landscape and related dynamics, including potential future changes to each, and can introduce and affect exposure to commercial, legal, and regulatory risk. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise. Protected names and marks This news release contains references to trademarks and other protected names and marks, including those belonging to other companies, persons, or entities. Solely for convenience, trademarks and other protected names and marks referred to in this news release may appear without the "®", "™", or other similar symbols. Each such reference should be read as though it appears with the relevant symbol. Any such references are not intended to indicate, in any way, that the holder or holders will not assert those rights to the fullest extent under applicable law. Non-GAAP measures Company management uses, and this news release refers to, financial measures that are not recognized under IFRS and do not have a standard meaning prescribed by generally accepted accounting principles (GAAP) in accordance with IFRS or other financial or accounting authorities (non-GAAP measures). These non-GAAP measures may include "non-GAAP financial measures" and "non-GAAP ratios" (each defined in National Instrument 52-112, Non-GAAP and Other Financial Measures Disclosure). Medexus's method for calculating these measures may differ from methods used by other companies and therefore these measures are unlikely to be comparable to similarly-designated measures used or presented by other companies. In particular, management uses Adjusted EBITDA (and Adjusted EBITDA Margin) and Adjusted Gross Margin (including Adjusted Gross Profit (Loss)) as measures of Medexus's performance. EBITDA (earnings before interest, taxes, depreciation, and amortization), Adjusted EBITDA (and Adjusted EBITDA Margin) and Adjusted Gross Profit (Loss) (gross profit (loss) before amortization of intangible assets) are non-GAAP financial measures, gross margin (gross profit (loss) divided by total revenue, expressed as a percentage) is a supplementary financial measure and Adjusted Gross Margin (Adjusted Gross Profit divided by total revenue, expressed as a percentage) is a non-GAAP ratio. An explanation and discussion of each of these non-GAAP measures, including their limitations, is set out under the heading "Preliminary Notes-Non-GAAP measures" in Medexus's most recent management's discussion and analysis, and is hereby incorporated by reference. A reconciliation of Adjusted EBITDA to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted EBITDA to Net Income (Loss)" below. A reconciliation of Adjusted Gross Margin to the most directly comparable IFRS measure can be found under the heading "Reconciliation of Adjusted Gross Margin" below. The following tables are derived from and should be read together with Medexus's consolidated financial statements for the 12-month period ended March 31, 2025. The supplementary disclosure is intended to more fully explain disclosures related to Adjusted EBITDA and Adjusted Gross Margin and provides additional information related to Medexus's operating performance. However, Medexus's non-GAAP measures have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of Medexus's financial information as reported under IFRS. Reconciliation of Adjusted EBITDA to Net Income (Loss) (Amounts in $ '000s) Fiscal quarter ended March 31, Fiscal year ended March 31,2025 2024 2025 2024Net income (loss) $ (553 ) $ 762$ 2,247$ (214 ) Add back: Depreciation and amortization (property, equipment, product licenses)2,436 1,449 7,178 5,806Financing costs2,005 2,224 8,195 13,364Income tax expense (recovery)(206 )228 (807 )320EBITDA3,682 4,663 16,813 19,276Add back: Share-based compensation119 125 1,056 939Transaction-related fees and expenses- 282 - 282Termination benefits541 823 897 823Foreign exchange loss (gain)65 377 1,068 165Unrealized loss (gain) on fair value of derivatives- - - (82 ) Unrealized gain on fair value of business combination payables(2,480 )(2,759 )(2,480 )(2,759 ) Impairment loss338 888 2,801 888Adjusted EBITDA2,265 4,399 20,155 19,532Adjusted EBITDA Margin (%)9.2% 16.9% 18.6% 17.3% Reconciliation of Adjusted Gross Margin (Amounts in $ '000s)Fiscal quarter ended March 31, Fiscal year ended March 31,2025 2024 2025 2024Net revenue24,754 25,962 108,332 113,054Cost of sales12,322 12,657 51,748 53,540Gross profit12,432 13,305 56,584 59,514Gross margin50.2% 51.2% 52.2% 52.6%Add back: Amortization of product licenses2,359 1,387 6,925 5,555Adjusted Gross Profit14,791 14,080 63,509 65,069Adjusted Gross Margin59.8% 56.6% 58.6% 57.6% To view the source version of this press release, please visit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-06-2025
- Business
- Yahoo
Medexus Schedules Fourth Fiscal Quarter and Fiscal Year 2025 Conference Call
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - June 17, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) plans to host a conference call at 8:00 am Eastern Time on Thursday, June 26, 2025 to discuss Medexus's results for its fourth fiscal quarter and fiscal year ended March 31, 2025. Medexus expects to file its financial statements and MD&A after markets close on June 25, 2025. To participate in the call, please dial the following numbers: 888-506-0062 (toll-free) for Canadian and U.S. callers+1 973-528-0011 for international callers Access code: 266173 A live webcast of the call will be available on the Investors section of Medexus's corporate website or at the following link: A replay of the call will be available approximately one hour following the end of the call through Thursday, July 3, 2025. To access the replay, please dial the following numbers – 877-481-4010 for Canadian and U.S. callers+1 919-882-2331 for international callers Conference ID: 52642 A replay of the webcast will be available on the Investors section of Medexus's corporate website until Friday, June 26, 2026. About Medexus Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology-oncology and allergy, dermatology, and rheumatology. For more information about Medexus and its product portfolio, please see the company's corporate website at and its filings on SEDAR+ at Contacts Ken d'Entremont | CEO, Medexus PharmaceuticalsTel: 905-676-0003 | Email: Brendon Buschman | CFO, Medexus PharmaceuticalsTel: 416-577-6216 | Email: Forward-looking statements Certain statements made in this news release contain forward-looking information within the meaning of applicable securities laws (forward-looking statements). The words "anticipates", "believes", "expects", "will", "plans", "potential", and similar words, phrases, or expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise. To view the source version of this press release, please visit Fehler beim Abrufen der Daten Melden Sie sich an, um Ihr Portfolio aufzurufen. Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten
