~ Achieved Second Quarter 2024 Total Net Revenues of $7.3 Million ~
~ Appointed Jeffrey S. Hackman as Chief Executive Officer (CEO) and Member of the Board of Directors ~
~ Company Has Approximately $43 Million in Cash, Cash Equivalents, and Investment Securities ~
~ Management to Host Conference Call Today at 8:30 a.m. ET ~
Research Triangle Park, NC, August 13, 2024 – Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the second quarter ended June 30, 2024, and provided a business update.
“We continued to execute well in the second quarter and are encouraged by the early third quarter momentum of PEDMARK® within the community oncology and the adolescent and young adult (AYA) population,” said Jeff Hackman, chief executive officer of Fennec Pharmaceuticals. “I am excited to join Fennec and take on the challenge of guiding the Company towards greater commercial success. We will focus on expanding our initial outreach to community oncology centers and the adolescent and young adult (AYA) population, who can greatly benefit from our treatments. By reaching more patients in these critical areas, I am confident that we can drive growth and make a significant impact in improving patient outcomes.”
Recent Developments and Highlights:
- Appointed Jeffery Hackman as Fennec’s New CEO and Board Member: Jeff has been appointed as the new Chief Executive Officer and a member of the Board of Directors. With a passion for patients and a track record of success, Jeff is poised to make an immediate impact by driving Fennec’s strategic direction and leading the Company into its next exciting phase of growth. Rosty Raykov will continue to contribute as a member of the Board of Directors.
- NCCN AYA Guidelines Updated: The NCCN Adolescent and Young Adult (AYA) Guidelines have been modified to remove “pediatric” specific wording. This change is instrumental in solidifying PEDMARK’s position for access to a broader patient population to prevent ototoxicity, both with payers and providers.
- Participation in Key Scientific Meetings: During the second quarter, Fennec actively participated in key regional and national scientific meetings, including the American Society of Clinical Oncology (ASCO), the Advanced Practice Providers Oncology Summit (APPOS), and the Oncology Nursing Society (ONS) annual meetings. These engagements underscore our commitment to advancing oncology care and fostering strong relationships within the healthcare community.
Financial Results for the Second Quarter 2024
- Net Sales – The Company recorded net product sales of $7.3 million for the three-month period ended June 30, 2024, compared to $3.3 million in net sales for the same period in 2023.
- Cash Position – Cash and cash equivalents were $43.1 million on June 30, 2024. The increase in cash and cash equivalents between June 30, 2024, and December 31, 2023, is the result of approximately $43 million from the Norgine transaction and 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 June 30, 2024 will be sufficient to fund our planned operations for at least the next twelve months
- Selling and Marketing Expenses –The Company recorded $4.7 million in selling and marketing expenses for the period ended June 30, 2024, compared to $2.3 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 increased by $1.4 million over the same period in 2023 to $6.9 million. There was an increase in consulting, and professional costs related to European pre-commercialization related expenses in the 2024 period over the comparable period. European related expenses are expected to wind down after Q2 2024 with the announcement of the Norgine transaction in March 2024.
- Net Earnings – Net loss for the quarter ended June 30, 2024 was $5.6 million (basic and diluted loss of $0.20 per share) compared to a net loss of $5.4 million (basic and diluted loss of $0.21 per share) for the same period in 2023.
Q2 2024 Conference Call Information
Date: Tuesday, August 13, 2024
Time: 8:30 a.m. ET
Link: https://register.vevent.com/register/BI59b5706a6c00453a9eed343d4a210de9
To access the conference call, please register using https://register.vevent.com/register/BI59b5706a6c00453a9eed343d4a210de9. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.fennepharma.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 June 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.
Unaudited Condensed Consolidated
Statements of Operations:
(U.S. Dollars in thousands except share and per share amounts)
| Three Months Ended | |||||||
| June 30, | June 30, | ||||||
| 2024 | 2023 | ||||||
| Revenue | |||||||
| PEDMARK product sales, net | $ | 7,262 | $ | 3,325 | |||
| Licensing revenue | — | — | |||||
| Total revenue | 7,262 | 3,325 | |||||
| Operating expenses: | |||||||
| Cost of products sold | 608 | 148 | |||||
| Research and development | 157 | 8 | |||||
| Selling and marketing | 4,672 | 2,340 | |||||
| General and administrative | 6,864 | 5,495 | |||||
| Total operating expenses | 12,301 | 7,991 | |||||
| Loss from operations | (5,039) | (4,666) | |||||
| Other (expense)/income | |||||||
| Unrealized foreign exchange (loss) /gain | (17) | 5 | |||||
| Amortization expense | (23) | (73) | |||||
| Unrealized loss on securities | — | — | |||||
| Interest income | 570 | 115 | |||||
| Interest expense | (1,044) | (825) | |||||
| Total other expense | (514) | (778) | |||||
| Net loss | $ | (5,553) | $ | (5,444) | |||
| Basic net loss per common share | $ | (0.20) | $ | (0.21) | |||
| Diluted net loss per common share | $ | (0.20) | $ | (0.21) | |||
| Weighted-average number of common shares outstanding basic | 27,297 | 26,458 | |||||
| Weighted-average number of common shares outstanding diluted | 27,297 | 26,458 | |||||
Fennec Pharmaceuticals Inc.
Balance Sheets
(U.S. Dollars and shares in thousands)
| Unaudited | Audited | |||||
| June 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | $ | 43,054 | $ | 13,269 | ||
| Accounts receivable, net | 12,312 | 8,814 | ||||
| Prepaid expenses | 4,379 | 2,575 | ||||
| Inventory | 2,144 | 2,156 | ||||
| Other current assets | 283 | 44 | ||||
| Total current assets | 62,172 | 26,858 | ||||
| Non-current assets | ||||||
| Other non-current assets, net amortization | 989 | 6 | ||||
| Total non-current assets | 989 | 6 | ||||
| Total assets | $ | 63,161 | $ | 26,864 | ||
| Liabilities and shareholders’ deficit | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 4,447 | $ | 3,778 | ||
| Accrued liabilities | 3,038 | 3,754 | ||||
| Operating lease liability – current | 12 | 21 | ||||
| Contract liability – Norgine | 252 | — | ||||
| Total current liabilities | 7,749 | 7,553 | ||||
| Long-term liabilities | ||||||
| Term loan | 30,000 | 30,000 | ||||
| PIK interest | 2,022 | 1,219 | ||||
| Debt discount | (247) | (288) | ||||
| Operating lease liability – net of current portion | — | 2 | ||||
| Contract liability – Norgine | 24,994 | — | ||||
| Total long-term liabilities | 56,769 | 30,933 | ||||
| Total liabilities | 64,518 | 38,486 | ||||
| Shareholders’ deficit: | ||||||
| Common stock, no par value; unlimited shares authorized; 27,328 shares issued and outstanding (2023 ‑27,027) | 145,281 | 144,307 | ||||
| Additional paid-in capital | 64,080 | 62,073 | ||||
| Accumulated deficit | (211,961) | (219,245) | ||||
| Accumulated other comprehensive income | 1,243 | 1,243 | ||||
| Total shareholders’ deficit | (1,357) | (11,622) | ||||
| Total liabilities and shareholders’ deficit | $ | 63,161 | $ | 26,864 | ||
Working Capital
| Working capital | Fiscal Period Ended | |||||
| Selected Asset and Liability Data: | June 30, 2024 | December 31, 2023 | ||||
| (U.S. Dollars in thousands) | ||||||
| Cash and equivalents | $ | 43,054 | $ | 13,269 | ||
| Other current assets | 19,118 | 13,589 | ||||
| Current liabilities | 7,749 | 7,553 | ||||
| Working capital | $ | 54,423 | $ | 19,305 | ||
| Selected Equity: | ||||||
| Common stock and additional paid in capital | 209,361 | 206,380 | ||||
| Accumulated deficit | (211,961) | (219,245) | ||||
| Shareholders’ (deficit) equity | (1,357) | (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.[i]
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.[ii] 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.[iii]
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.7 PEDMARK is also the only therapeutic agent with proven efficacy and safety data with an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical 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] 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.