~ Achieved Full-Year PEDMARK® Net Product Sales of $29.6 Million, Up 40% Year-Over-Year, and Generated PEDMARK® Q4 2024 Net Product Sales of $7.9 Million ~
~ Delivered Q4 2024 EBITDA Loss of $0.6 Million and Company Has $26.6 Million in Cash, Cash Equivalents and Short‑Term Investments ~
~ Completed Early Repayment of $13 Million of the Company’s Convertible Debt Facility ~
~ Continued Momentum in the Adolescent and Young Adult (AYA) Segment and Academic Setting Following Strategic Investments to Drive Awareness of Ototoxicity & Adoption of PEDMARK ~
~ PEDMARQSI® Now Commercially Available to Patients and Healthcare Providers in the United Kingdom and Germany ~
~ Japan Clinical Trial (STS-J01) Results Expected in the Second Half of 2025 ~
~ Management to Host Conference Call Today at 8:30 a.m. ET ~
Research Triangle Park, NC, March 10, 2025 – Fennec Pharmaceutcals Inc. (NASDAQ:FENC; TSX: FRX), a specialtypharmaceutcal company, today reported its fnancial results for the fscal year ended December 31, 2024 and provided a business update.
“2024 marked the beginning of a foundatonal transformaton for Fennec, setng the stage for the PEDMARK® strategy that we are utlizing throughout 2025 to realize our next phase of growth. With key management and commercial hires in Q3 and Q4, we strengthened our leadership team and with this enhanced expertse, we are now well-positoned to drive executon and excellence in the feld. We are seeing encouraging momentum in early 2025, partcularly with adopton by academic insttutons and new patent segments, reinforcing the value and need for PEDMARK®,” said Jef Hackman, chief executve ofcer of Fennec Pharmaceutcals. “Global access to PEDMARK® has also expanded meaningfully, with recent PEDMARQSI® commercial launches in the United Kingdom and Germany in 2025. With the right foundatonal strategies now in place, we are confdent that our strong and focused executon will translate into signifcant shareholder value in 2025 and beyond.”
Business Highlights:
- U.S. Clinical Compendia Update: All medical compendia have incorporated Fennec’s clinical updates, andAHFS, the largest online platorm for pharmacists, has updated its content to refect and diferentate PEDMARK® in accordance with its labeling. We also contnue to advance our eforts to have PEDMARK® added to the NCCN Drug and Biologics Compendium®, a key step in further expanding access and reimbursement pathways.
- PEDMARQSIÒ Commercial Launch in Europe: In December 2024, Norgine received positve guidance fromNatonal Insttute for Health and Care Excellence (NICE) recommending PEDMARQSI® for the preventon of cisplatn-induced hearing loss in patents (aged 1 month to 17 years) with localized, non-metastatc,
solid tumors and PEDMARQSI® is currently available in the U.K. In February 2025, Norgine announced that it has commercially launched PEDMARQSI® in Germany. Both milestones mark an important step in achieving Fennec’s mission of expanding access to PEDMARQSI® to cancer patents across the globe at risk of hearing loss.
- Ex-U.S. Opportunites for PEDMARKÒ: In Japan, the investgator-initated clinical trial (STS-J01) in Japanevaluatng PEDMARKÒ fully enrolled in Q4 2024 and the results of the trial are expected in the second half of 2025 with the potental evaluaton for registraton of PEDMARK® in Japan thereafer. Further, Fennec has partnered with Inpharmus, formerly named TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC, for the distributon of PEDMARK® in Turkey and Gulf Cooperaton Council Countries.
- Early Repayment of $13 Million of the Company’s Approximately $32 Million Outstanding Convertble Debt Facility: In December 2024, Fennec announced the early partal repayment of a signifcant porton ofits debt to Petrichor in a fnancial and strategic acton that optmizes the Company’s balance sheet and overall capital structure, while efectvely saving approximately $1.5 million in future annual interest payments and eliminatng potental dilutve shares.
Financial Results for the Fourth Quarter and Full Fiscal Year Ended December 31, 2024
- Net Product Sales – For the fourth quarter of 2024, the Company recorded net product sales of $7.9 millioncompared to $7.0 million in the third quarter of 2024, representng an increase of approximately 13%. For the full fscal year (FY) 2024, the Company recorded $29.6 million compared to $21.3 million in 2023, representng an increase of approximately 40%. The increase in sales in both the quarter and year refects strong growth in accounts and increased penetraton in the AYA market opportunity.
- Cash Positon – Cash and cash equivalents were $26.6 million as of December 31, 2024. Of note, for thefourth quarter of 2024, our cash fow from operatons decreased by $0.6 million. For the FY 2024, there was a $13.4 million increase in cash and cash equivalents between December 31, 2023 and December 31,
2024. The increase in cash was primarily due to the $43 million in upfront cash from the Norgine transacton and cash collected from product sales ofset by operatng expenses and the $13 million convertble debt paydown in December 2024.
- Selling and Marketng Expenses – The Company recorded $3.9 million in selling and marketng expenses inthe fourth quarter of 2024 compared to $4.6 million in the third quarter of 2024. For the FY 2024, the
Company recorded $18.4 million in selling and marketng compared to $12.1 million in fscal year 2023. The increase is largely related to increased payroll and additonal marketng expenses in the comparable periods as we focused on expanding our outreach to community oncology centers and the adolescent and young adult (AYA) populaton.
- General and Administratve (G&A) Expenses – The Company recorded $4.1 million in G&A expenses fourthquarter of 2024 compared to $7.0 million in the third quarter of 2024. For the FY 2024, the Company recorded $23.1 million in G&A expenses compared to $20.6 million in fscal year 2023. For the fourth quarter of 2024, G&A expenses decreased due largely to lower cash based stock compensaton and a one-tme severance payment related to the previous CEO in the third quarter. For the full year G&A expenses were higher both due to European pre-commercializaton related expenses, expenses associated with the Norgine transacton and intellectual property expenses related to ongoing litgaton.
Fourth Quarter and Full-Year 2024 Conference Call Informaton
Date: Monday, March 10, 2025
Time: 8:30 a.m. ET
Webcast Link: htps://edge.media-server.com/mmc/p/7bafd7q
Partcipant Link: htps://register.vevent.com/register/BIeb244773eed644bd83882935e4272e91
To access the live webcast link, log onto www.fennecpharma.com and proceed to the News & Events/Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate tme for any sofware download that may be required to listen to the webcast. A webcast replay of the conference call will also be archived on www.fennecpharma.com for thirty days.
Financial Update
The selected fnancial data presented below is derived from our unaudited condensed consolidated fnancial statements, which were prepared in accordance with U.S. generally accepted accountng principles. The complete audited condensed consolidated fnancial statements for the period ended December 31, 2024 and management’s discussion and analysis of fnancial conditon and results of operatons will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.
| Unaudited Consolidated | ||||||||||||||||||||||||||||
| Statements of Operations: | ||||||||||||||||||||||||||||
| ( |
||||||||||||||||||||||||||||
| Three Months Ended | Twelve Months Ended | |||||||||||||||||||||||||||
| 2024 | 2023 |
2024 | 2023 | |||||||||||||||||||||||||
| Revenue | ||||||||||||||||||||||||||||
| Product sales, net | $ | 7,925 | $ | 9,735 | $ | 29,580 | $ | 21,252 | ||||||||||||||||||||
| Licensing revenue | — | — | 17,958 | — | ||||||||||||||||||||||||
| Total revenue | 7,925 | 9,735 | 47,538 | 21,252 | ||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||||
| Cost of product sales | 669 | 685 | 3,184 | 1,259 | ||||||||||||||||||||||||
| Research and development | 50 | 32 | 307 | 56 | ||||||||||||||||||||||||
| Selling and marketing | 3,944 | 3,868 | 18,426 | 12,123 | ||||||||||||||||||||||||
| General and administrative | 4,196 | 6,968 | 23,053 | 20,585 | ||||||||||||||||||||||||
| Total operating expenses | 8,859 | 11,553 | 44,970 | 34,023 | ||||||||||||||||||||||||
| Loss from operations | (934 | ) | (1,818 | ) | 2,568 | (12,771 | ) | |||||||||||||||||||||
| Other (expense)/income | ||||||||||||||||||||||||||||
| Realized foreign exchange (loss)/gain | (27 | ) | 2 | (82 | ) | 5 | ||||||||||||||||||||||
| Amortization expense | (25 | ) | (70 | ) | (89 | ) | (287 | ) | ||||||||||||||||||||
| Unrealized loss on securities | (66 | ) | 4 | (80 | ) | (39 | ) | |||||||||||||||||||||
| Interest income | 399 | 115 | 1,682 | 441 | ||||||||||||||||||||||||
| Interest expense | (966 | ) | (915 | ) | (4,069 | ) | (3,394 | ) | ||||||||||||||||||||
| Total other (expense)/income | (685 | ) | (864 | ) | (2,638 | ) | (3,274 | ) | ||||||||||||||||||||
| Net (loss) / income | $ | (1,619 | ) | $ | (2,682 | ) | $ | (70 | ) | $ | (16,045 | ) | ||||||||||||||||
| Basic net loss per common share | $ | (0.06 | ) | $ | (0.10 | ) | $ | (0.00 | ) | $ | (0.60 | ) | ||||||||||||||||
| Diluted net loss per common share | $ | (0.06 | ) | $ | (0.10 | ) | $ | (0.00 | ) | $ | (0.60 | ) | ||||||||||||||||
| Weighted-average number of common shares outstanding basic | 27,460 | 26,833 | 27,294 | 26,574 | ||||||||||||||||||||||||
| Weighted-average number of common shares outstanding diluted | 27,460 | 26,833 | 27,294 | 26,574 | ||||||||||||||||||||||||
| Unaudited Consolidated Balance Sheets: | ||||||||||||||
| ( |
||||||||||||||
| 2024 | 2023 | |||||||||||||
| Assets | ||||||||||||||
| Current assets | ||||||||||||||
| Cash and cash equivalents | $ | 26,634 | $ | 13,269 | ||||||||||
| Accounts receivable, net | 12,884 | 8,814 | ||||||||||||
| Prepaid expenses | 3,080 | 583 | ||||||||||||
| Inventory | 1,060 | 2,156 | ||||||||||||
| Other current assets | 364 | 21 | ||||||||||||
| Total current assets | 44,022 | 24,843 | ||||||||||||
| Non-current assets | ||||||||||||||
| Other non-current assets, net of amortization | 924 | 2,021 | ||||||||||||
| Total non-current assets | 924 | 2,021 | ||||||||||||
| Total assets | $ | 44,946 | $ | 26,864 | ||||||||||
| Liabilities and shareholders’ (deficit) equity | ||||||||||||||
| Current liabilities: | ||||||||||||||
| Accounts payable | $ | 2,875 | $ | 3,778 | ||||||||||
| Accrued liabilities | 3,428 | 3,754 | ||||||||||||
| Operating lease liability – current | 248 | 21 | ||||||||||||
| Contract liability – current | 2 | — | ||||||||||||
| Total current liabilities | 6,553 | 7,553 | ||||||||||||
| Long term liabilities | ||||||||||||||
| Term loan | 18,206 | 30,000 | ||||||||||||
| PIK interest | 1,271 | 1,219 | ||||||||||||
| Debt discount | (139 | ) | (288 | ) | ||||||||||
| Contract liability – long-term | 24,561 | 2 | ||||||||||||
| Total long term liabilities | 43,899 | 30,933 | ||||||||||||
| Total liabilities | 50,452 | 38,486 | ||||||||||||
| Commitments and Contingencies | ||||||||||||||
| Shareholders’(deficit) equity: | ||||||||||||||
| Common stock, no par value; unlimited shares authorized; 27,292 shares issued and outstanding (2023 ‑26,361) | 145,608 | 144,307 | ||||||||||||
| Additional paid-in capital | 66,958 | 62,073 | ||||||||||||
| Accumulated deficit | (219,315 | ) | (219,245 | ) | ||||||||||
| Accumulated other comprehensive income | 1,243 | 1,243 | ||||||||||||
| Total shareholders’ (deficit) equity | (5,506 | ) | (11,622 | ) | ||||||||||
| Total liabilities and shareholders’ (deficit) equity | $ | 44,946 | $ | 26,864 | ||||||||||
| Working capital | Fiscal Year Ended | |||||||
| Selected Asset and Liability Data: | ||||||||
| ( |
||||||||
| Cash and equivalents | $ | 26,634 | $ | 13,269 | ||||
| Other current assets | 17,388 | 11,574 | ||||||
| Current liabilities | 6,553 | 7,553 | ||||||
| Working capital | $ | 37,469 | $ | 17,290 | ||||
| Selected Equity: | ||||||||
| Common stock and additional paid in capital | 212,566 | 206,380 | ||||||
| Accumulated deficit | (219,315 | ) | (219,245 | ) | ||||
| Shareholders’ equity | (5,506 | ) | (11,622 | ) | ||||
About Cisplatn-Induced Ototoxicity
Cisplatn and other platnum compounds are essental chemotherapeutc agents for the treatment of many malignancies. Unfortunately, platnum-based therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and partcularly harmful to the survivors of pediatric cancer.i
The incidence of ototoxicity depends upon the dose and duraton of chemotherapy, and many of these children require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over tme.ii Infants and young children that are afected by ototoxicity at critcal stages of development lack speech and language development and literacy, and older children and adolescents ofen lack social-emotonal development and educatonal achievement.iii
PEDMARK® (sodium thiosulfate injecton)
PEDMARK® is the frst and only U.S. Food and Drug Administraton (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatn treatment in pediatric patents with localized, non-metastatc, solid tumors. It is a unique formulaton of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patents. PEDMARK is also the frst and only therapeutc agent with proven efcacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.
As a reminder, PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatn in pediatric patents 1 month of age and older with localized, non-metastatc solid tumors. PEDMARK is recommended for the AYA populaton by the Natonal Comprehensive Cancer Network, or NCCN, with a 2A endorsement.
In the U.S. and Europe, it is estmated that, annually, more than 10,000 children may receive platnum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duraton of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventve agent for this hearing loss and only expensive, technically difcult, and sub-optmal cochlear (inner ear) implants have been shown to provide some beneft. Infants and young children that sufer ototoxicity at critcal stages of development lack speech language development and literacy, and older children and adolescents lack social-emotonal development and educatonal achievement.
PEDMARK has been studied by co-operatve groups in two Phase 3 clinical studies of survival and reducton of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatn therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patents with localized tumors.
Indicatons and Usage
PEDMARK® (sodium thiosulfate injecton) is indicated to reduce the risk of ototoxicity associated with cisplatn in pediatric patents 1 month of age and older with localized, non-metastatc solid tumors.
Limitatons of Use
The safety and efcacy of PEDMARK have not been established when administered following cisplatn infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatn infusions, because irreversible ototoxicity may have already occurred.
PEDMARK is contraindicated in patents with history of a severe hypersensitvity to sodium thiosulfate or any of its components.
Hypersensitvity reactons occurred in 8% to 13% of patents in clinical trials. Monitor patents for hypersensitvity reactons. Immediately discontnue PEDMARK and insttute appropriate care if a hypersensitvity reacton occurs. Administer anthistamines or glucocortcoids (if appropriate) before each subsequent administraton of PEDMARK. PEDMARK may contain sodium sulfte; patents with sulfte sensitvity may have hypersensitvity reactons, including anaphylactc symptoms and life-threatening or severe asthma episodes. Sulfte sensitvity is seen more frequently in people with asthma.
PEDMARK is not indicated for use in pediatric patents less than 1 month of age due to the increased risk of hypernatremia or in pediatric patents with metastatc cancers.
Hypernatremia occurred in 12% to 26% of patents in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patents in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patents. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patents with baseline serum sodium greater than 145 mmol/L.
Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular fltraton rate (GFR) falls below 60 mL/min/1.73m2.
Administer antemetcs prior to each PEDMARK administraton. Provide additonal antemetcs and supportve care as appropriate.
The most common adverse reactons (≥25% with diference between arms of >5% compared to cisplatn alone) in SIOPEL 6 were vomitng, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reacton (≥25% with diference between arms of >5% compared to cisplatn alone) in COG ACCL0431 was hypokalemia.
Please see full Prescribing Informaton for PEDMARK® at: www.PEDMARK.com.
About Fennec Pharmaceutcals
Fennec Pharmaceutcals Inc. is a specialty pharmaceutcal company focused on the development and commercializaton of PEDMARK® to reduce the risk of platnum-induced ototoxicity in pediatric patents. Further, PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023 and U.K. approval in October 2023 under the brand name PEDMARQSIÒ. PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketng Authorizaton in Europe which includes eight years plus two years of data and market protecton. For more informaton, please visit www.fennecpharma.com.
Forward Looking Statements
Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK®/PEDMARQSI®, the market opportunity for and market impact of PEDMARK®/ PEDMARQSI®, its potential impact on patients and anticipated benefits associated
with its use, future commercial and regulatory milestone and royalty payments from Norgine, and potential
access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks
and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, our ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2024. Fennec disclaims any obligation to update these forward-looking statements except as required by law.
For a more detailed discussion of related risk factors, please refer to our public flings available at www.sec.gov and www.sedar.com.
PEDMARK® PEDMARQSI® and Fennec® are registered trademarks of Fennec Pharmaceutcals Inc.
©2025 Fennec Pharmaceutcals Inc. All rights reserved. FEN-1604-v1
For further informaton, please contact:
Investors:
Robert Andrade
Chief Financial Ofcer
Fennec Pharmaceutcals Inc.
+1 919-246-5299
Corporate and Media:
Lindsay Rocco
Elixir Health Public Relatons
+1 862-596-1304
- Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369.
ii Landier W. Ototoxicity and Cancer Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658.
iii Bass JK, Knight KR, Yock TI, et al. Evaluation and Management of Hearing Loss in Survivors of Childhood and Adolescent Cancers: A Report from the Children’s Oncology Group. Pediatric Blood & Cancer. 2016 Jul;63(7):1152-1162.