Core Viewpoint - Fennec Pharmaceuticals Inc. is set to release its first quarter 2025 financial results on May 13, 2025, and will host a conference call to discuss these results [1] Group 1: Financial Results Announcement - The company will announce its first quarter 2025 financial results before the U.S. financial markets open on May 13, 2025 [1] - A conference call and webcast will be held on the same day to discuss the financial and business results [1] Group 2: Conference Call & Webcast Details - The conference call is scheduled for 8:30 a.m. ET on May 13, 2025 [2] - Links for the webcast and participant registration are provided, with a recommendation to connect at least 15 minutes prior to the call [2] Group 3: Company Overview - Fennec Pharmaceuticals focuses on developing and commercializing PEDMARK, aimed at reducing platinum-induced ototoxicity in pediatric patients [3] - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI [3] - The product has Orphan Drug Exclusivity in the U.S. and Pediatric Use Marketing Authorization in Europe, providing significant market protection [3]

Group 1 - Adherex Technologies Inc. (FENC) closed at $6.19, with an 11.9% gain over the past four weeks, and a mean price target of $13.20 suggests an upside potential of 113.3% [1] - The mean estimate includes five short-term price targets with a standard deviation of $2.05, indicating variability among analysts; the lowest estimate of $10 suggests a 61.6% increase, while the highest estimate of $15 indicates a 142.3% increase [2] - Analysts show strong agreement in revising earnings estimates higher, which correlates with potential stock price movements, as the Zacks Consensus Estimate for the current year has increased by 134.6% over the past month [11][12] Group 2 - FENC holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates, indicating strong potential upside in the near term [13] - While price targets are often viewed as a key metric, they can mislead investors; analysts may set overly optimistic targets due to business incentives, which can inflate expectations [7][8] - A low standard deviation in price targets suggests a high degree of agreement among analysts regarding the stock's price movement direction, serving as a starting point for further research [9]

Group 1 - Adherex Technologies Inc. (FENC) has experienced a significant downtrend, with a stock decline of 22.2% over the past four weeks, indicating strong selling pressure [1] - The stock is currently in oversold territory, as indicated by an RSI reading of 29.08, suggesting that the heavy selling may be exhausting itself and a rebound could be imminent [5] - There is a strong consensus among Wall Street analysts regarding FENC's ability to report better earnings than previously predicted, with a 124.3% increase in the consensus EPS estimate over the last 30 days [7] Group 2 - FENC holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [8] - The upward trend in earnings estimate revisions typically correlates with price appreciation in the near term, further supporting the case for a potential rebound in FENC's stock price [7]

Financial Performance - As of December 31, 2024, the company had $24.6 million in money market investments, an increase from $11.9 million at December 31, 2023, indicating a significant growth in liquid assets [555]. - The company has not experienced any loss or write-down of its money market investments for the years ended December 31, 2024, and 2023, reflecting stable investment performance [556]. - The company has a history of significant losses and limited revenue generation from product sales since inception, highlighting financial challenges [15]. Investment Strategy - The investment policy prioritizes preservation of principal, liquidity, and return on investment, with minimal risk associated with fluctuating interest rates [557]. Regulatory and Market Challenges - The commercialization of PEDMARK® is critical, as the company is a single product entity with limited commercial experience, complicating future financial forecasts [19]. - Regulatory approvals for PEDMARK® have been obtained, but ongoing regulatory review and potential restrictions remain a concern for market acceptance [19]. - The company may require additional financing for further product development and regulatory approvals, which could impact operational capabilities [15]. - The company faces substantial competition in the biopharmaceutical market, which could adversely affect its market position and financial performance [19]. Operational Risks - The company is subject to foreign currency risks, holding approximately CAD$0.16 million and €0.24 million as of December 31, 2024, to manage obligations in Canada and the EU [558]. - The company relies on third parties for raw materials and manufacturing, and any failure in their performance could materially impact business operations [17].

Financial Performance - Full-Year PEDMARK® net product sales reached $29.6 million, a 40% increase year-over-year, with Q4 2024 net product sales of $7.9 million[1] - The company reported a Q4 2024 EBITDA loss of $0.6 million and had $26.6 million in cash, cash equivalents, and short-term investments[1] - Cash flow from operations decreased by $0.6 million in Q4 2024, but there was a $13.4 million increase in cash and cash equivalents from December 31, 2023, to December 31, 2024[7] - Selling and marketing expenses for FY 2024 were $18.4 million, up from $12.1 million in FY 2023, primarily due to increased payroll and marketing efforts[7] - General and administrative expenses for FY 2024 were $23.1 million, compared to $20.6 million in FY 2023, influenced by European pre-commercialization expenses and costs associated with the Norgine transaction[8] Debt Management - Early repayment of $13 million of the company's convertible debt facility was completed, optimizing the balance sheet and saving approximately $1.5 million in future annual interest payments[7] Product Development and Approval - PEDMARK® is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors[18] - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023[31] - The Japan clinical trial (STS-J01) for PEDMARK® is fully enrolled, with results expected in the second half of 2025, potentially leading to registration in Japan[7] - PEDMARQSI® is now commercially available in the United Kingdom and Germany, expanding global access to the product[2] Clinical Efficacy and Safety - PEDMARK has proven efficacy and safety data established through two Phase 3 clinical studies, COG ACCL0431 and SIOPEL 6[21] - The COG ACCL0431 protocol enrolled patients with various childhood cancers treated with intensive cisplatin therapy, while SIOPEL 6 focused on hepatoblastoma patients[21] - Hypersensitivity reactions occurred in 8% to 13% of patients during clinical trials, necessitating monitoring for such reactions[25] - Hypernatremia occurred in 12% to 26% of patients, while hypokalemia occurred in 15% to 27% of patients during clinical trials[27] - The most common adverse reactions in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia, while hypokalemia was most common in COG ACCL0431[29] Market Potential and Strategy - Over 10,000 children in the U.S. and Europe may receive platinum-based chemotherapy annually, with many requiring lifelong hearing aids due to ototoxicity[20] - Fennec Pharmaceuticals emphasizes the potential market impact and commercialization plans for PEDMARK, alongside anticipated regulatory milestones and funding opportunities[32] - The company is focused on expanding access to PEDMARQSI® for cancer patients at risk of hearing loss, with significant milestones achieved in Europe[5]

Financial Data and Key Metrics Changes - In 2024, the company reported a revenue growth of approximately 40% year-over-year, with net product sales of $29.6 million compared to $21.3 million in 2023 [28][30] - For Q4 2024, net product sales were $7.9 million, reflecting a quarterly growth rate of approximately 13% [28] - The company managed to burn only approximately $0.6 million in cash for Q4 2024, demonstrating operational efficiency [34] Business Line Data and Key Metrics Changes - The pediatric segment continued to show growth, while the adolescent and young adult (AYA) segment emerged as a significant opportunity [38] - Selling and marketing expenses for Q4 2024 were $3.9 million, down from $4.6 million in Q3 2024, while full-year expenses increased to $18.4 million from $12.1 million in 2023 [29][30] Market Data and Key Metrics Changes - The U.S. AYA oncology landscape is estimated to have approximately 20,000 cisplatin chemotherapy patients treated annually, with significant market potential [11][12] - The product PEDMARK is gaining traction in major academic centers, which is critical for broader market acceptance [14] Company Strategy and Development Direction - The company is focused on expanding awareness of the unmet need for preventing cisplatin-induced ototoxicity and establishing PEDMARK as the standard of care [9][10] - The PEDMARK strategy will be utilized throughout 2025 to drive growth, with a focus on both pediatric and AYA populations [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential for 2025, particularly in the second half of the year as foundational initiatives take effect [29][41] - The company anticipates additional compendia listings and is actively engaging with stakeholders to support positive outcomes for PEDMARK's inclusion in guidelines [17][18] Other Important Information - The company has launched PEDMARQSI in Germany and the U.K., with pricing set at £8277 in the U.K. and over €10,500 per vial in Germany [20][21] - The company reported a cash position of $26.6 million as of December 31, 2024, following a significant debt repayment [33] Q&A Session Summary Question: Did the pediatric business return to sequential growth in Q4, and what was the AYA contribution? - Management confirmed continued growth in the pediatric segment and highlighted the AYA segment as an incredible opportunity, though specific breakdowns were not provided [38] Question: What is the expected inflection in the AYA segment for 2025? - Management indicated significant opportunities in the AYA segment and expected accelerated growth in the second half of 2025 [41] Question: What progress has Norgine made in Europe? - Management noted that the product is commercially available in the U.K. and Germany, with ongoing updates expected as more countries get approved [48][49] Question: What is the competitive landscape for PEDMARK in the U.S.? - Management acknowledged the presence of compounded products but emphasized the adoption of PEDMARK in major institutions, indicating progress despite competition [72] Question: Will clinical trials be run for potential label expansions? - Management indicated openness to discussions regarding label expansions and will provide updates as developments occur [75] Question: How does the company prioritize commercial efforts between community centers and academic institutions? - Management emphasized the importance of both settings and noted that awareness levels in the AYA space present a significant opportunity for growth [90]

Financial Data and Key Metrics Changes - In 2024, the company reported a revenue growth of approximately 40% year-over-year, with net product sales of $29.6 million compared to $21.3 million in 2023 [28][30] - For Q4 2024, net product sales were $7.9 million, reflecting a quarterly growth rate of approximately 13% [28] - The company managed to burn only approximately $0.6 million in cash for Q4 2024, demonstrating operational efficiency [34] Business Line Data and Key Metrics Changes - The pediatric segment continued to show growth, while the adolescent and young adult (AYA) segment emerged as a significant opportunity [38] - Selling and marketing expenses for Q4 2024 were $3.9 million, down from $4.6 million in Q3 2024, while full-year expenses increased to $18.4 million from $12.1 million in the previous year [29][30] Market Data and Key Metrics Changes - The U.S. AYA oncology landscape is estimated to have approximately 20,000 cisplatin chemotherapy patients treated annually, with significant market potential [11] - The product PEDMARK is gaining traction in major academic centers, which is critical for broader market acceptance [14] Company Strategy and Development Direction - The company is focused on expanding awareness of the unmet need for preventing cisplatin-induced ototoxicity and establishing PEDMARK as the standard of care [9][10] - The PEDMARK strategy will be utilized throughout 2025 to drive growth, with a focus on increasing adoption among oncologists and ensuring access for patients [7][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential for PEDMARK, particularly in the AYA segment, and anticipates significant growth in the second half of 2025 [41][42] - The company is actively engaging with stakeholders to support the inclusion of PEDMARK in key compendia, which is expected to enhance access and reimbursement pathways [17][18] Other Important Information - The company has launched PEDMARQSI in Germany and the U.K., with pricing set at £8277 in the U.K. and over €10,500 in Germany [20][21] - The company anticipates receiving a €10 million milestone upon obtaining final pricing approval in Germany [34] Q&A Session Summary Question: Did the pediatric business return to sequential growth in Q4, and what was the AYA contribution? - Management confirmed continued growth in the pediatric segment and highlighted the AYA segment as an incredible opportunity, though specific breakdowns were not provided [38] Question: What is the expected inflection in the AYA segment for 2025? - Management indicated significant opportunities in the AYA segment and expects accelerated growth in the second half of the year [41][42] Question: What progress has Norgine made in Europe regarding key centers of excellence? - Management noted that the product is now commercially available in the U.K. and Germany, with ongoing updates expected as more countries are approved [48][49] Question: What is the competitive landscape for PEDMARK in the U.S.? - Management acknowledged the presence of compounded products but emphasized the adoption of PEDMARK in major institutions, indicating progress despite competition [72] Question: Will clinical trials be run for potential label expansions? - Management indicated openness to discussions regarding label expansions and will provide updates as developments occur [75]

Core Viewpoint - Adherex Technologies Inc. reported a quarterly loss of $0.06 per share, significantly missing the Zacks Consensus Estimate of $0.56, marking an earnings surprise of -110.71% [1][2] Financial Performance - The company posted revenues of $7.93 million for the quarter ended December 2024, which was 73.17% below the Zacks Consensus Estimate and down from $9.74 million year-over-year [2] - Over the last four quarters, Adherex Technologies has not surpassed consensus EPS estimates and has only topped revenue estimates once [2] Stock Performance - Adherex Technologies shares have increased by approximately 8.9% since the beginning of the year, contrasting with a -1.9% decline in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.17 on revenues of $8.7 million, and for the current fiscal year, it is -$0.15 on revenues of $57.11 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Adherex Technologies belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Core Insights - Fennec Pharmaceuticals reported a significant increase in net product sales for PEDMARK, achieving $29.6 million for the full fiscal year 2024, which is a 40% increase year-over-year, and $7.9 million in Q4 2024, reflecting a 13% increase from the previous quarter [1][11][32] - The company has strengthened its leadership team and is focused on expanding the adoption of PEDMARK in academic institutions and new patient segments, particularly in the adolescent and young adult (AYA) market [3][32] - Fennec has successfully launched PEDMARQSI in the UK and Germany, enhancing global access to its product aimed at preventing cisplatin-induced hearing loss in pediatric patients [1][6][32] Financial Performance - For the fiscal year 2024, total revenue reached $47.5 million, with net product sales contributing $29.6 million, compared to $21.3 million in 2023 [11][12] - The company reported a cash position of $26.6 million as of December 31, 2024, with a notable increase in cash and cash equivalents of $13.4 million from the previous year [11][14] - Selling and marketing expenses increased to $18.4 million for FY 2024, up from $12.1 million in FY 2023, reflecting the company's efforts to expand outreach [11][12] Strategic Developments - Fennec completed an early repayment of $13 million of its convertible debt facility, optimizing its balance sheet and saving approximately $1.5 million in future interest payments [1][6] - The company is advancing its efforts to include PEDMARK in the NCCN Drug and Biologics Compendium, which is crucial for expanding access and reimbursement pathways [6][32] - A clinical trial in Japan (STS-J01) is fully enrolled, with results expected in the second half of 2025, potentially leading to registration of PEDMARK in Japan [1][6]

Core Viewpoint - Fennec Pharmaceuticals Inc. is set to release its full year and fourth quarter 2024 financial results on March 10, 2025, and will host a conference call to discuss these results [1][2]. Company Overview - Fennec Pharmaceuticals is a specialty pharmaceutical company focused on developing and commercializing PEDMARK®, which aims to reduce the risk of platinum-induced ototoxicity in pediatric patients [3]. - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI [3]. - The product has been granted Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing eight years plus two years of data and market protection [3]. Conference Call & Webcast Details - The conference call is scheduled for March 10, 2025, at 8:30 a.m. Eastern Time, with a live webcast available [2]. - Participants are advised to connect to the company's website at least 15 minutes prior to the call for any necessary software downloads [2]. - A replay of the conference call will be archived on the company's website for thirty days [2].