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Fennec Pharmaceuticals, Inc.

Fennec Pharmaceuticals, Inc. Q3 FY2024 earnings call

November 9, 2024 · fiscal period ended 2024-09

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Summary

Generated 2024-11-09

Management highlights

  • Jeff discussed recent progress including market expansion, academic endorsements, new demographic interest (Adolescent and Young Adult - AYA) segment, educational investments, operational efficiencies, and strengthened leadership.
  • Key initiatives for PEDMARK: Increasing awareness of unmet patient need, cementing PEDMARK as the standard of care for cisplatin-induced ototoxicity (CIO) prevention, having PEDMARK adopted by HCPs beyond oncologists, ensuring seamless access for the product, and activating patients/caregivers through disease education.
  • AYA segment: Significant market potential with over 10,000 patients treated annually with cisplatin. In Q3, surpassed >90% reimbursement in AYA population, partnered with Orsini for home administration of PEDMARK to AYA patients, and saw adoption in select academic centers. Expected to ramp up in coming quarters.
  • Ex-U.S. launch: PEDMARK expected to launch in Germany and UK in coming months. Investigator-initiated trial in Japan evaluating PEDMARK was fully enrolled in October 2024, results expected in 2025 with potential for registration/licensing in Japan.
  • Strengthened executive team: Pierre Sayad as Chief Medical Officer, Terry Evans as Chief Commercial Officer, and Christiana Cioffi as Chief Strategy Officer, bringing experienced biopharmaceutical industry expertise to drive commercial strategy for PEDMARK.
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Segment performance

For the first nine months of 2024, the company recorded approximately $22 million in net product sales, more than all of 2023's net product sales. In the third quarter of 2024, net product sales were $7.0 million compared to $6.5 million in the comparable quarter of 2023. General and administrative expenses in Q3 2024 were $6.1 million, selling and marketing expenses were $4.6 million. The company ended the third quarter with approximately $40.3 million in cash, cash equivalents, and investment securities.

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Guidance

  • Expect the AYA segment to ramp up in the coming quarters.
  • PEDMARK is expected to launch in Germany and the UK in the coming months, generating additional revenue for Fennec in 2025.
  • Results of the investigator-initiated trial in Japan evaluating PEDMARK are expected in 2025, with potential for evaluation of registration and/or partnering/licensing of PEDMARK in Japan thereafter.
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Risks

  • Forward-looking statements are subject to risks and uncertainties detailed in the company's periodic and current event filings with the U.S. Securities and Exchange Commission.
  • IP litigation is ongoing, but the company's IP portfolio has strengthened significantly with six Orange Book patents in the portfolio over the last two years.
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Q&A highlights

Q: About the AYA market acceleration and growth, do you feel everything is in place to drive growth and should we expect meaningful growth sequentially?

A: Jeff believes the commercial opportunity for PEDMARK in AYA is significant, new talent in marketing and medical will help move the opportunity forward, and the progress in Q3 signals a significant growth opportunity.

Q: Could you provide qualitative color on business development priorities and the status of IP litigation?

A: Jeff discussed evaluating open territories and the Japan trial's enrollment, with results expected in the first half of 2025 to inform business development. Robert mentioned the IP case is ongoing but the company's IP portfolio has strengthened with six Orange Book patents

View in transcript ↓

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Transcript

November 9, 2024

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