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Fennec Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update

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Fennec Pharmaceuticals (NASDAQ:FENC) reported Q3 2024 net product sales of $7.0 million, up from $6.5 million in Q3 2023. The company achieved over 90% reimbursement for PEDMARK in the AYA population. Despite increased sales, the company recorded a net loss of $5.7 million ($0.21 per share) compared to $1.9 million loss in Q3 2023. Operating expenses increased to $12.2 million from $7.5 million year-over-year. The company maintains a strong cash position of $40.3 million, expected to fund operations into at least 2026.

Fennec Pharmaceuticals (NASDAQ:FENC) ha riportato vendite nette di prodotto per il terzo trimestre 2024 pari a 7,0 milioni di dollari, in aumento rispetto a 6,5 milioni di dollari nel terzo trimestre 2023. L'azienda ha raggiunto oltre il 90% di rimborso per PEDMARK nella popolazione AYA. Nonostante l'aumento delle vendite, l'azienda ha registrato una perdita netta di 5,7 milioni di dollari (0,21 dollari per azione) rispetto a una perdita di 1,9 milioni di dollari nel terzo trimestre 2023. Le spese operative sono aumentate a 12,2 milioni di dollari rispetto a 7,5 milioni di dollari rispetto all'anno precedente. L'azienda mantiene una solida posizione di liquidità di 40,3 milioni di dollari, sufficiente a finanziare le operazioni almeno fino al 2026.

Fennec Pharmaceuticals (NASDAQ:FENC) reportó ventas netas de productos de 7,0 millones de dólares en el tercer trimestre de 2024, un aumento respecto a los 6,5 millones de dólares en el tercer trimestre de 2023. La compañía logró más del 90% de reembolso para PEDMARK en la población AYA. A pesar del aumento en las ventas, la compañía registró una pérdida neta de 5,7 millones de dólares (0,21 dólares por acción) en comparación con una pérdida de 1,9 millones de dólares en el tercer trimestre de 2023. Los gastos operativos aumentaron a 12,2 millones de dólares desde 7,5 millones de dólares en comparación con el año anterior. La empresa mantiene una fuerte posición de liquidez de 40,3 millones de dólares, que se espera que financie las operaciones al menos hasta 2026.

Fennec Pharmaceuticals (NASDAQ:FENC)는 2024년 3분기 제품 순매출이 700만 달러에 달했다고 보고했으며, 이는 2023년 3분기의 650만 달러에서 증가한 수치입니다. 이 회사는 AYA 인구에서 PEDMARK에 대해 90% 이상의 환급을 달성했습니다. 판매가 증가했음에도 불구하고, 회사는 2023년 3분기의 190만 달러 손실에 비해 570만 달러의 순손실(주당 0.21달러)을 기록했습니다. 운영 비용은 전년 대비 750만 달러에서 1220만 달러로 증가했습니다. 이 회사는 4030만 달러의 강력한 현금 위치를 유지하고 있으며, 이는 최소 2026년까지 운영 자금으로 사용될 것으로 예상됩니다.

Fennec Pharmaceuticals (NASDAQ:FENC) a rapporté des ventes nettes de produits de 7,0 millions de dollars pour le troisième trimestre 2024, en hausse par rapport à 6,5 millions de dollars au troisième trimestre 2023. L'entreprise a obtenu plus de 90% de remboursement pour PEDMARK dans la population AYA. Malgré l'augmentation des ventes, l'entreprise a enregistré une perte nette de 5,7 millions de dollars (0,21 dollar par action) par rapport à une perte de 1,9 million de dollars au troisième trimestre 2023. Les dépenses d'exploitation ont augmenté à 12,2 millions de dollars contre 7,5 millions de dollars d'une année sur l'autre. L'entreprise maintient une forte position de liquidités de 40,3 millions de dollars, qui devrait financer ses opérations jusqu'au moins 2026.

Fennec Pharmaceuticals (NASDAQ:FENC) hat für das dritte Quartal 2024 Nettoumsätze in Höhe von 7,0 Millionen Dollar gemeldet, was einem Anstieg gegenüber 6,5 Millionen Dollar im dritten Quartal 2023 entspricht. Das Unternehmen erzielte über 90% Rückerstattung für PEDMARK in der AYA-Bevölkerung. Trotz gestiegener Verkäufe verzeichnete das Unternehmen einen Nettverlust von 5,7 Millionen Dollar (0,21 Dollar pro Aktie) im Vergleich zu einem Verlust von 1,9 Millionen Dollar im dritten Quartal 2023. Die Betriebskosten stiegen von 7,5 Millionen Dollar auf 12,2 Millionen Dollar im Jahresvergleich. Das Unternehmen bleibt mit einer starken Liquiditätsposition von 40,3 Millionen Dollar aufgestellt, die voraussichtlich die Betriebsabläufe mindestens bis 2026 finanzieren wird.

Positive
  • Net product sales increased to $7.0M in Q3 2024 from $6.5M in Q3 2023
  • Achieved >90% reimbursement rate for PEDMARK in AYA population
  • Strong cash position of $40.3M sufficient to fund operations into 2026
  • Potential market expansion with 10,000 annual AYA patients eligible for treatment
Negative
  • Net loss widened to $5.7M in Q3 2024 from $1.9M in Q3 2023
  • Operating expenses increased 62% to $12.2M from $7.5M YoY
  • Selling and marketing expenses rose to $4.6M from $3.4M YoY
  • G&A expenses increased to $6.1M from $3.8M YoY

Insights

The Q3 results show mixed signals. While $7.0M in net product sales represents a modest 7% YoY growth, the company's net loss widened significantly to $5.7M from $1.9M YoY. Operating expenses surged by 62% to $12.2M, primarily due to increased marketing investments and G&A costs. The bright spots include a strong cash position of $40.3M, providing runway into 2026 and >90% reimbursement achievement for PEDMARK in the AYA population. The expanded market opportunity in AYA segment with 10,000 annual patients and upcoming European launch through Norgine partnership presents significant growth potential.

The market expansion strategy into the AYA segment represents a significant opportunity, with cisplatin-treated patient population of 10,000 annually. The high ototoxicity rates of 36% in adult cancer patients and 40-60% in pediatric patients indicate substantial market potential. The successful >90% reimbursement coverage in AYA segment and planned European market entry through Norgine partnership could drive future growth. However, increased operating expenses and widening losses suggest the company is in heavy investment phase, which may pressure short-term profitability but could pay off in long-term market penetration.

~ Achieved Third Quarter 2024 Net Product Sales of $7.0 Million ~

~ Increasing Momentum and Successful Reimbursement in the Adolescent and Young Adult (AYA) Segment Following Strategic Investments to Drive Awareness of Ototoxicity & Adoption of PEDMARK ~

~ Strengthened Executive Leadership Team with Chief Medical Officer, Chief Commercial Officer & Chief Strategy Officer Appointments ~

~ Company Has Approximately $40 Million in Cash, Cash Equivalents, and Investment Securities Expected to Fund Operations Into at Least 2026 ~

~ Management to Host Conference Call Today at 8:30 a.m. ET ~

RESEARCH TRIANGLE PARK, N.C., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the third quarter ended September 30, 2024, and provided a business update.

“I am pleased with the progress that we have made since recently joining Fennec in August as CEO. We are making significant headway that will position us for near-term and sustainable growth, including market expansion to the Adolescent and Young Adult (AYA) community with payor reimbursement, and adoption within prominent academic centers,” said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. “Our strategic and focused investments in educational initiatives reflect the strength of the foundation we are building upon with PEDMARK. Together with the recent executive leadership team appointments combined with Fennec’s talented employee base, I believe that we are well positioned to execute, accelerate growth and unlock value across all key market segments.”

Recent Developments and Highlights:

  • Appointed Pierre S. Sayad, PhD, M.S., as chief medical officer, Terry Evans as chief commercial officer and Christiana Cioffi, MBA, as chief strategy officer. Seasoned biopharmaceutical industry executives with proven clinical, commercial, sales, operational, and oncology market expertise will significantly accelerate our ability to build upon and seamlessly execute our integrated commercial strategy for PEDMARK and create shareholder value.

  • Surpassed greater than 90% reimbursement for PEDMARK in the AYA population in Q3. Insights from a market and situational analysis to better understand patient incidence and addressable patient populations identified significant near-and long-term opportunities across the Pediatric and AYA market segments. The opportunity for the AYA segment is significant with at least 10,000 patients treated annually with cisplatin, including primary tumors such as germ cell tumors and thyroid tumors. The incidence of ototoxicity induced by cisplatin has been estimated to be 36% of adult patients with cancer and 40%-60% of pediatric cancer patients.i

  • PEDMARQSI commercial launch in Europe: Following the exclusive licensing agreement announcement executed in March with Norgine, PEDMARQSI is expected to be available in select markets in Europe in the coming months, which will generate additional revenue for Fennec in 2025 and beyond.

  • Investigator-initiated clinical trial (STS-J01) in Japan evaluating PEDMARK fully enrolled in October 2024: The clinical trial of STS-J01 evaluates the efficacy and safety of PEDMARK in reducing ototoxcity induced by cisplatin in children and AYAs with localized solid tumors. The primary endpoint of the trial is to assess the frequency of hearing impairment at the end of treatment. Results of the trial are expected in 2025 with the potential evaluation for registration of PEDMARK in Japan thereafter.

  • Participation in Key Scientific Meetings: During the third quarter, Fennec actively participated in key regional and national scientific meetings, including the National Community Oncology Dispensing Association (NCODA) International Fall Summit, the Testicular Cancer Awareness Foundation’s annual Conference and the Association of Pediatric Hematology/Oncology Nurses (APHON) annual meeting.

Financial Results for the Third Quarter 2024

  • Net Product Sales – The Company recorded net product sales of $7.0 million for the three-month period ended September 30, 2024, compared to $6.5 million in net product sales for the same period in 2023.

  • Cash Position – Cash and cash equivalents were $40.3 million on September 30, 2024. Cash decreased by $2.7 million over the previous quarter. The decrease in cash is the result of cash inflows from net sales offset by cash outlays for operating expenses related to the promotion of our product, selling and marketing expenses and general and administrative expenses. We anticipate that our cash, cash equivalents and investment securities as of September 30, 2024 will be sufficient to fund our planned operations into at least 2026.

  • Selling and Marketing Expenses –The Company recorded $4.6 million in selling and marketing expenses for the period ended September 30, 2024, compared to $3.4 million for the same period in 2023. The increase is largely related to additional selling and marketing expenses as the Company expanded its focus in the AYA and community oncology population during 2024.

  • General and Administrative (G&A) Expenses – G&A expenses were $6.1 million compared to $3.8 million in the same period in 2023 and $6.9 million in the second quarter of 2024. The increase includes additional expenses related to non-cash equity compensation, one-time severance related to our previous CEO and ongoing IP litigation expenses.

  • Net Earnings – Net loss for the quarter ended September 30, 2024 was $5.7 million (basic and diluted loss of $0.21 per share) compared to a net loss of $1.9 million (basic and diluted loss of $0.07 per share) for the same period in 2023.

Q3 2024 Conference Call Information

Date:  Thursday, November 7, 2024
Time: 8:30 a.m. ET
Link:  https://edge.media-server.com/mmc/p/e6my278s

To access the conference call, dial 888-596-4144 or 646-968-2525 internationally and referencing the conference access ID: 6896851. 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 time for any software 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 financial data presented below is derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended September 30, 2024 and management's discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

      
 Three Months Ended
 September 30, September 30,
 2024
 2023
      
Revenue     
PEDMARK product sales, net$6,974  $6,515 
Total revenue 6,974   6,515 
      
Operating expenses:     
Cost of products sold 1,357
   331 
Research and development 97   12 
Selling and marketing 4,601   3,384 
General and administrative 6,121   3,805 
      
Total operating expenses 12,176   7,532 
Loss from operations (5,202)   (1,017) 
      
Other (expense)/income     
Unrealized foreign exchange loss    (11) 
Amortization expense (21)   (72) 
Unrealized loss on securities (3)   (13) 
Interest income 516   102 
Interest expense (1,025)   (856) 
Total other (expense)/income (533)   (850) 
      
Net loss$(5,735)  $(1,867) 
      
Basic net loss per common share$(0.21)  $(0.07) 
Diluted net loss per common share$(0.21)  $(0.07) 
Weighted-average number of common shares outstanding basic 27,371   26,596 
Weighted-average number of common shares outstanding diluted 27,371   26,596 


       
  Unaudited Audited
  September 30, December 31,
  2024
 2023
       
Assets      
       
Current assets      
Cash and cash equivalents $40,320  $13,269 
Accounts receivable, net  12,908   8,814 
Prepaid expenses  3,066   2,575 
Inventory  1,125   2,156 
Other current assets  546   44 
Total current assets  57,965   26,858 
       
Non-current assets      
Deferred issuance cost, net amortization  956   6 
Total non-current assets  956   6 
Total assets $58,921  $26,864 
       
Liabilities and shareholders’ (deficit) equity      
       
Current liabilities:      
Accounts payable $3,867  $3,778 
Accrued liabilities  3,313   3,754 
Deferred revenue - current  248    
Operating lease liability - current  7   21 
Total current liabilities  7,435   7,553 
       
Non-current liabilities      
Term loan  30,000   30,000 
PIK interest  2,323   1,219 
Debt discount  (227)  (288)
Contract liability  24,561   2 
Total non-current liabilities  56,657   30,933 
Total liabilities  64,092   38,486 
       
Shareholders’(deficit) equity:      
Common stock, no par value; unlimited shares authorized; 27,422 shares issued and outstanding (2023 ‑27,027)  145,438   144,307 
Additional paid-in capital  65,844   62,073 
Accumulated deficit  (217,696)  (219,245)
Accumulated other comprehensive income  1,243   1,243 
Total shareholders’ (deficit) equity  (5,171)  (11,622)
Total liabilities and shareholders’ (deficit) equity $58,921  $26,864 


Working Capital

       
Working capital Fiscal Period Ended
Selected Asset and Liability Data: September 30, 2024
 December 31, 2023
(U.S. Dollars in thousands)      
Cash and equivalents $40,320  $13,269 
Other current assets  17,645   13,589 
Current liabilities  7,435   7,553 
Working capital $50,530  $19,305 
       
       
Selected Equity:      
Common stock and additional paid in capital  211,282   206,380 
Accumulated deficit  (217,696)  (219,245)
Shareholders’ (deficit) equity  (5,171)  (11,622)
         

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum compounds are essential chemotherapeutic agents for the treatment of many pediatric malignancies. Unfortunately, platinum-based therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.ii

The incidence of ototoxicity depends upon the dose and duration 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 time.iii Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development and literacy, and older children and adolescents often lack social-emotional development and educational achievement.iv

PEDMARK® (sodium thiosulfate injection)
PEDMARK® is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy 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.

In the U.S. and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin 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 patients with localized tumors.

Indications and Usage
PEDMARK® (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information
PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK® at: www.PEDMARK.com.

About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® to reduce the risk of platinum-induced ototoxicity in pediatric patients. 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 PEDMARQSI. PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. For more information, 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®, the market opportunity for and market impact of PEDMARK®, its potential impact on patients and anticipated benefits associated with its use, 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, 2023. 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 filings available at www.sec.gov and www.sedar.com.

PEDMARK® and Fennec® are registered trademarks of Fennec Pharmaceuticals Inc.

©2024 Fennec Pharmaceuticals Inc. All rights reserved. FEN-1604-v1

For further information, please contact:

Investors:
Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299

Corporate and Media:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
lrocco@elixirhealthpr.com


i Asmi Chattaraj et al., Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract 19, 278-283(2023). DOI:10.1200/OP.22.00710 https://ascopubs.org/doi/10.1200/OP.22.00710#:~:text=The%20incidence%20of%20ototoxicity%20induced,%25%2D60%25%20of%20pediatric%20patients.&text=Ototoxicity%20can%20be%20vestibular%20or,pain%2C%20and%20frank%20hearing%20loss.
ii Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369.
iii Landier W. Ototoxicity and Cancer Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658.
iv 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.


FAQ

What were Fennec Pharmaceuticals (FENC) Q3 2024 net product sales?

Fennec Pharmaceuticals reported net product sales of $7.0 million for Q3 2024, compared to $6.5 million in Q3 2023.

What is the current cash position of Fennec Pharmaceuticals (FENC)?

As of September 30, 2024, Fennec Pharmaceuticals had $40.3 million in cash and cash equivalents, expected to fund operations into at least 2026.

What was Fennec Pharmaceuticals' (FENC) net loss in Q3 2024?

Fennec Pharmaceuticals reported a net loss of $5.7 million ($0.21 per share) in Q3 2024, compared to a net loss of $1.9 million ($0.07 per share) in Q3 2023.

What is the reimbursement rate for PEDMARK in the AYA population for FENC?

Fennec Pharmaceuticals achieved greater than 90% reimbursement for PEDMARK in the AYA (Adolescent and Young Adult) population in Q3 2024.

Fennec Pharmaceuticals Inc.

NASDAQ:FENC

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165.97M
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6.8%
Biotechnology
Biological Products, (no Disgnostic Substances)
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