~ 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.
- 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.
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 | ||||||
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