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Medexus Pharmaceuticals Inc
Symbol MDP
Shares Issued 32,258,003
Close 2025-04-07 C$ 2.17
Market Cap C$ 69,999,867
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Medexus talks up market response to Grafapex

2025-04-07 16:19 ET - News Release

Mr. Ken d'Entremont reports

MEDEXUS PROVIDES UPDATE ON PROGRESS OF COMMERCIALIZATION OF GRAFAPEX (TREOSULFAN) FOR INJECTION

Medexus Pharmaceuticals Inc. has provided a business update on the progress of the commercial launch of Grafapex (treosulfan) for injection in the United States and has discussed the company management's participation in two upcoming investor conferences.

Medexus has seen an encouraging market response to Grafapex in the weeks since the February 24 commercial launch of the product. Several procedures using commercially available Grafapex have already occurred, which is consistent with company expectations regarding initial institutional uptake and patient-level demand for the product. Initial formulary inclusion determinations, both by national payors and individual health care institutions, are another promising indicator of the product's commercial potential, with progress to date likewise consistent with company expectations. And, on Feb. 28, National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of leading cancer centers devoted to patient care, research and education, included treosulfan in its NCCN Clinical Practice Guidelines in Oncology (NCCN guidelines).

"We have made good progress already, in the handful of weeks since commercial launch," said 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. We have sold product to 16 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."

"We anticipate the annual product-level adjusted gross margin of Grafapex to be approximately 80 per cent," added Brendon Buschman, Medexus's chief financial officer. "This would compare favourably to the portfolio-wide adjusted gross margin we have achieved in recent fiscal quarters, being 56.3 per cent for fiscal Q3 2025 and 59.5 per cent for fiscal Q2 2025. Combined with our expectation of at least $100-million (U.S.) in annual product-level revenue within five years after commercial launch, which this initial uptake makes us now more confident in than ever, we continue to see Grafapex as being accretive to the portfolio and the company in the coming years."

As another indicator of the tailwinds supporting the Grafapex launch in the United States, members of the medical and scientific community presented 34 presentations and abstracts relating to treosulfan at the 2025 annual meeting of the EBMT (formerly known as the European Society for Blood and Marrow Transplantation), a congress for all those involved in the care of transplant and cellular therapy patients, in Florence (Italy) from March 30 to April 2, 2025.

"We are extremely pleased with this early progress," concluded Dr. Virginie Bernier, PhD, vice-president-hemato-oncology at Medexus. "Performance to date, and the response from the market and the attention to treosulfan from the medical and scientific community, supports our confidence that Grafapex will make a substantial contribution to alloHSCT in the United States, and also solidify Medexus's leadership position in this therapeutic field."

Medexus is aware that the United States has recently implemented new and/or increased tariffs on imports into the United States and additional such tariffs or restrictions may be forthcoming. Medexus is monitoring this evolving international trade situation and will evaluate the potential impact of these developments on its revenue and cost structure in due course.

Company management will be available to discuss the company's commercialization activities at the LD Micro Invitational XV in New York from April 9 to April 10, 2025, and the 2025 Bloom Burton & Co. Health Care Investor Conference in Toronto from May 5 to May 6, 2025. Details regarding Medexus's participation will be available on the investors -- news and events section of Medexus's corporate website.

About Grafapex (treosulfan) for injection

Grafapex (treosulfan) for injection, an alkylating agent, is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients one year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (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 Food and Drug Administration-approved indication.

About Medexus Pharmaceuticals Inc.

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.

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