Summary of Fennec Pharmaceuticals FY Conference Call Company Overview - **Company**: Fennec Pharmaceuticals (NasdaqCM:FENC) - **Product**: PEDMARK, the first and only FDA-approved product to prevent cisplatin-induced ototoxicity [1][3] Industry Context - **Target Market**: Pediatric patients aged 1-18 and adolescents/young adults (AYA) aged 15-39 receiving cisplatin for localized non-metastatic tumors [4][6] - **Cisplatin Usage**: Approximately 2,000 pediatric patients and 20,000 AYA patients treated annually with cisplatin in the U.S. [5][29] Core Product Insights - **Efficacy**: PEDMARK has proven efficacy and safety data established through two phase three trials, with recent positive results from a trial in Japan [3][46] - **Administration**: PEDMARK is administered as a 15-minute IV infusion six hours after cisplatin treatment [25] - **Market Segmentation**: The product targets two segments: pediatric (2,000 patients) and AYA (20,000 patients), with a focus on germ cell/testicular cancer patients [5][13] Commercial Strategy - **Sales Infrastructure**: Fennec has approximately 40 employees, with half in customer-facing roles, including traditional sales reps and medical science liaisons (MSLs) [20][21] - **Growth in Awareness**: The company has doubled its MSL presence and established key account directors to enhance awareness in larger oncology networks [21][22] - **Home Health Administration**: About 33-40% of PEDMARK patients are now receiving infusions at home, reflecting growth in this area [27] Financial Performance - **Sales Growth**: Quarterly sales increased from approximately $7 million to $12.5 million, primarily driven by the AYA market [29] - **Pricing**: The wholesale acquisition cost (WAC) for PEDMARK is $11,000 per vial, with a gross-to-net discount of about 20% [39][40] Regulatory and Market Access - **Payer Reimbursement**: 100% reimbursement achieved across major carriers, indicating strong payer support for PEDMARK [38] - **Intellectual Property**: Fennec holds orphan drug exclusivity until September 2029 and six Orange Book patents extending to July 2039 [44] International Expansion - **Japan**: Positive trial results in Japan are expected to facilitate approval and market entry, with plans to partner with local entities [46][47] - **Europe**: Fennec has partnered with Norgine for European distribution, with initial launches in the UK and Germany [50][51] Challenges and Considerations - **Awareness Among Practitioners**: There is a need to increase awareness of PEDMARK among oncologists and nurses, particularly in community settings [32][33] - **Ototoxicity Management**: Education is crucial as once hearing loss occurs, it is irreversible, emphasizing the importance of prophylactic use of PEDMARK [35][36] Future Outlook - **Potential for Expansion**: Interest in conducting trials for PEDMARK in metastatic disease and adult populations is being explored [48] - **Continued Growth**: The company aims to build awareness and expand its market presence, particularly in the AYA segment [33][39]

Core Insights - Fennec Pharmaceuticals Inc. will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025, at 1:00 p.m. ET, available via webcast [1][2] Company Overview - Fennec Pharmaceuticals is a specialty pharmaceutical company focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy [3] - The company is commercializing PEDMARK, which aims to reduce the risk of platinum-induced ototoxicity in cancer patients [3] - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI [3] Licensing and Commercialization - In March 2024, Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for the commercialization of PEDMARQSI in Europe, U.K., Australia, and New Zealand [4] - PEDMARQSI is currently commercially available in the U.K. and Germany [4] Regulatory Status and Market Protection - PEDMARK has received Orphan Drug Exclusivity in the U.S., while PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing eight years plus two years of data and market protection [5] - Fennec holds patents protecting PEDMARK until 2039 in both the U.S. and internationally [5]

Core Insights - Fennec Pharmaceuticals has successfully repurchased and redeemed all outstanding convertible notes issued to Petrichor Opportunities Fund, eliminating its debt [1][2] - The total cost for the repurchase and redemption of the Petrichor notes was approximately $21.73 million, which included principal, accrued interest, and a redemption fee [2] - Fennec is focused on the commercialization of PEDMARK, a drug aimed at reducing platinum-induced ototoxicity in cancer patients, which has received multiple regulatory approvals [3][5] Financial Summary - The aggregate repurchase and redemption price of the Petrichor notes was $21,729,455.30, comprising $19,476,655.48 in principal, $305,134.27 in accrued interest, and a $1,947,665.55 redemption fee [2] - Prior to redemption, the notes had an interest rate tied to the prime rate with a floor of 3.5% plus a margin rate of 4.5% [2] Product and Market Information - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI [3] - Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand [4] - PEDMARK has Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing significant market protection [5]

Core Points - Fennec Pharmaceuticals Inc. has closed a non-brokered offering of common shares in Canada at a price of US$7.50 per share, raising aggregate gross proceeds of US$5,025,000 [1][2] Group 1: Offering Details - The offering was made to prospective purchasers in Canada (excluding Quebec) under the listed issuer financing exemption, and the common shares are not subject to a hold period under Canadian securities laws [2][4] - The offering document related to this transaction can be accessed on the Company's profile at www.sedarplus.com and www.fennecpharma.com [3] Group 2: Company Overview - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients receiving cisplatin-based chemotherapy, with its primary product being PEDMARK, which received FDA approval in September 2022 and European Commission approval in June 2023 [6][8] - PEDMARQSI, the brand name for PEDMARK in the U.K., received approval in October 2023, and the product is now commercially available in the U.K. and Germany following an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. [7][8] Group 3: Regulatory and Market Position - PEDMARK has received Orphan Drug Exclusivity in the U.S., and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing significant market protection [8] - Fennec holds patents for PEDMARK that extend until 2039 in both the U.S. and internationally, enhancing its competitive position in the market [8]

Core Viewpoint - Fennec Pharmaceuticals Inc. has successfully closed a public offering of 5,366,667 common shares at a price of $7.50 per share, raising approximately $40.25 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering included the full exercise of the underwriters' option to purchase additional shares [1]. - The net proceeds will be used to repurchase certain indebtedness and for working capital and general corporate purposes [2]. - Piper Sandler & Co. and Craig-Hallum Capital Group LLC served as joint book-running managers, with H.C. Wainwright & Co. as lead manager and Stephens Inc. as co-manager [2]. Group 2: Company Overview - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy, primarily through its product PEDMARK [5]. - PEDMARK received FDA approval in September 2022, followed by approvals from the European Commission in June 2023 and the U.K. in October 2023 under the name PEDMARQSI [5]. - In March 2024, Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand [6]. Group 3: Regulatory and Market Position - PEDMARK has Orphan Drug Exclusivity in the U.S., while PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing it with a total of ten years of market protection [7]. - Fennec holds patents for PEDMARK that extend until 2039 in both the U.S. and internationally [7].

Core Viewpoint - Fennec Pharmaceuticals Inc. is initiating a non-brokered offering of common shares in Canada at a price of US$7.50 per share, aiming for gross proceeds of up to US$5,025,000, with the offering expected to close on November 17, 2025, subject to customary closing conditions [1][2]. Offering Details - The offering targets prospective purchasers in Canada (excluding Quebec) under the listed issuer financing exemption, and the shares will not be subject to a hold period under Canadian securities laws [2][4]. - There are no guarantees regarding the completion of the offering or the total gross proceeds raised [2]. Company Background - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy, with its product PEDMARK approved by the FDA in September 2022 and by the European Commission in June 2023 [6][8]. - The company has an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand, with the product already available in the U.K. and Germany [7]. Regulatory and Market Position - PEDMARK has received Orphan Drug Exclusivity in the U.S., and PEDMARQSI has Pediatric Use Marketing Authorization in Europe, providing significant market protection [8]. - Fennec holds patents for PEDMARK that extend until 2039 in both the U.S. and internationally, enhancing its competitive position in the market [8].

Core Viewpoint - Fennec Pharmaceuticals Inc. has announced a public offering of 4,666,667 common shares priced at $7.50 per share, aiming to raise approximately $35 million in gross proceeds before expenses [1][2] Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 700,000 common shares under the same terms [1] - The expected closing date for the offering is November 17, 2025, pending customary closing conditions [1] Group 2: Use of Proceeds - The net proceeds from the offering will be used to repurchase and redeem certain indebtedness, with any remaining funds allocated for working capital and general corporate purposes [2] Group 3: Company Background - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy, with its product PEDMARK approved by the FDA in September 2022 and by the European Commission in June 2023 [5][6] - The company has entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand [6] - PEDMARK has received Orphan Drug Exclusivity in the U.S., and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing significant market protection [7]

Core Viewpoint - Fennec Pharmaceuticals Inc. is initiating an underwritten public offering of its common shares, with plans to use the proceeds for debt repayment and general corporate purposes [1][2]. Group 1: Offering Details - The company intends to offer common shares and grant underwriters a 30-day option to purchase an additional 15% of the shares sold in the offering [1]. - The offering is being conducted under a registration statement that has been declared effective by the SEC, with a preliminary prospectus supplement to be filed [3]. Group 2: Use of Proceeds - Net proceeds from the offering will be used to repurchase certain indebtedness, with any remaining funds allocated for working capital and general corporate purposes [2]. Group 3: Company Background - Fennec Pharmaceuticals focuses on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy, primarily through its product PEDMARK, which has received various regulatory approvals [5][6]. - PEDMARK has Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing significant market protection [7].

Core Insights - Fennec Pharmaceuticals reported a record net product sales of $12.5 million for Q3 2025, representing a 79% year-over-year growth, marking the strongest quarter in the company's history [1][8] - The company achieved positive cash flow from operations, with cash and cash equivalents increasing to $22 million as of September 30, 2025 [1][8] - The preliminary results of the clinical trial STS-J01 in Japan are expected in Q4 2025, which could lead to potential registration and partnership opportunities for PEDMARK if results are favorable [1][7] Financial Performance - Net product sales for Q3 2025 were approximately $12.5 million, up from $7.0 million in Q3 2024, indicating significant growth [8][10] - Selling and marketing expenses increased to $5.2 million in Q3 2025 from $4.4 million in Q2 2025 and $4.6 million in Q3 2024 [8] - General and administrative expenses decreased slightly to $6.8 million in Q3 2025 from $7.0 million in Q2 2025 [8] Business Developments - The adoption of PEDMARK has accelerated within key oncology provider networks, reflecting growing confidence in its clinical value [7] - The company is engaged with key opinion leaders and has multiple investigator-initiated studies under review, which are expected to strengthen its clinical and commercial foundation [7] - Fennec's strategy to enhance its commercial organization and drive broader adoption of PEDMARK is showing tangible results [2][7] Upcoming Events - Fennec Pharmaceuticals will host one-on-one investor meetings at the 16th Annual Craig-Hallum Alpha Select Conference on November 18, 2025 [4]

Core Insights - Fennec Pharmaceuticals reported total net revenues of $9.7 million for Q2 2025, reflecting a 33% increase compared to the same quarter in 2024, driven by growth in large community practices and academic centers [1][3][9] - The company has seen a successful uptake of its product PEDMARQSI in the UK and Germany, with plans for additional EU launches [1][3] - The management anticipates results from a clinical trial in Japan (STS-J01) in the second half of 2025, which may lead to registration and potential licensing opportunities [1][3] Financial Performance - Net product sales for Q2 2025 were approximately $9.7 million, up from $7.3 million in Q2 2024, attributed to growth in the adolescent and young adult (AYA) population [9][11] - Selling and marketing expenses decreased to $4.4 million in Q2 2025 from $4.6 million in Q2 2024, while general and administrative expenses increased slightly to $7.0 million from $6.9 million [9][11] - The company reported a net loss of $3.2 million for Q2 2025, compared to a net loss of $5.6 million in Q2 2024 [11] Business Highlights - Fennec's segmentation model and data-driven targeting have led to significant growth in both new and repeat customers, particularly in large community and academic practices [6] - A large national oncology group has added PEDMARK to its formulary for patients under 40, indicating growing recognition of the need to protect younger patients from cisplatin-induced hearing loss [6] - The NCODA PQI issued for PEDMARK aims to provide clinical data and guidance for healthcare professionals managing patients on cancer therapies [6] Upcoming Events - Fennec will ring the NASDAQ closing bell on September 5, 2025, alongside PEDMARK patients and their families [10] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City [10] Product Information - PEDMARK is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients [15][19] - The product has received Orphan Drug Exclusivity in the U.S. and is commercially available in the U.K. and Germany under the brand name PEDMARQSI [28][30]