Reports Q1 revenue $1.7M, consensus $1.85M. "Cash and cash equivalents were $18.4 million at March 31, 2023 and $23.8 million at December 31, 2022. The decrease in cash and cash equivalents between March 31, 2023, and December 31, 2022, is the result of cash outlays for operating expenses related to the promotion of our product, small amounts of research and development and general and administrative expenses, which were offset by cash inflows from product sales. We anticipate that our cash, cash equivalents and investment securities as of March 31, 2023 will be sufficient to fund our planned operations for at least the next twelve months."
Cantor Fitzgerald analyst Charles Duncan raised the firm's price target on Fennec Pharmaceuticals to $16 from $12 and keeps an Overweight rating on the shares. The company's cash balance should be sufficient to support it through the early innings of the Pedmark launch, which is progressing well as Fennec generated net product sales of $1.5M in less than one quarter post-launch, the analyst tells investors in a research note. The firm believes early demand is being driven by awareness of previously disclosed data and the potential for Pedmark to create durable pharmacoeconomic value for pediatric cisplatin-induced hearing loss patients. As such, it has enhanced conviction on the early innings of Fennec's commercial build.
Fennec Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has issued a positive opinion and recommended granting a Marketing Authorization for Pedmarqsi - known as PEDMARK in the U.S. - for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to less than18 years of age with localized, non-metastatic, solid tumors. When formally approved by the European Commission, Pedmarqsi will be the first and only treatment approved in the European Union to address this area of significant unmet medical need. "There are currently no approved treatments in Europe to mitigate the risk of permanent and irreversible bilateral hearing loss which occurs in approximately 60 percent of children treated with cisplatin and can be as high as 90 percent.1 The CHMP positive opinion brings European patients and their families closer to having a preventive treatment option to prevent the devastating consequences of hearing loss following the use of cisplatin chemotherapy, an indispensable treatment of choice in many pediatric cancer cases," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "With approximately five thousand children eligible for treatment with a platinum-based chemotherapy each year in Europe, we are excited by the potential this therapy can offer to the pediatric oncology community."
Fennec Pharmaceuticals announced that the U.S. FDA has granted Orphan Drug Exclusivity to PEDMARK, which is indicated to reduce the risk of ototoxicity, or hearing loss, associated with cisplatin use in pediatric patients one month of age and older with localized, non-metastatic solid tumors. The seven-year market exclusivity for PEDMARK began on September 20, 2022, the date of its FDA approval, and continues until September 20, 2029. Additionally, in the approved prescribing label, the FDA has explicitly directed that PEDMARK is not substitutable with other sodium thiosulfate products
Cantor Fitzgerald analyst Charles Duncan reiterates an Overweight rating on Fennec with a $12 price target after the company announced that the National Comprehensive Cancer Network updated its clinical practice guidelines for adolescent and young adult oncology to include Pedmark to help reduce the risk of hearing loss. The news is "incremental" but a "potentially useful enhancement" to awareness for Pedmark's clinical data-driven profile, the analyst tells investors in a research note. The firm sees the inclusion of Pedmark as an "encouraging predictor of increased uptake" following its approval in September of 2022.
Wedbush analyst David Nierengarten lowered the firm's price target on Fennec to $17 from $19 and keeps an Outperform rating on the shares after the NCCN included PEDMARK in its updated guidelines for adolescent and young adult oncology practice. According to the guidelines, pediatric patients should routinely be evaluated for tinnitus and monitored for hearing loss associated with cisplatin or carboplatin-based therapy, and the use of PEDMARK should be considered to reduce the risk of ototoxicity associated with cisplatin chemotherapy in pediatric patients with non-metastatic solid tumors. The firm believes the NCCN recommendation will help to drive uptake of PEDMARK, which was commercially launched in October 2022 after receiving a broad label in September. Wedbush continues to view Fennec as an attractive buyout candidate for a midsize pharmaceutical company on the basis of PEDMARK's broad label and strong pricing, and with an EV of just $250M, the firm sees considerable room for shares to move, either organically or via M&A.
Fennec Pharmaceuticals announced that the National Comprehensive Cancer Network has updated its clinical practice guidelines for Adolescent and Young Adult Oncology to include PEDMARK to help reduce the risk of ototoxicity associated with cisplatin use in pediatric patients with localized, non-metastatic solid tumors.
Cantor Fitzgerald analyst Charles Duncan upgraded Fennec Pharmaceuticals to Overweight from Neutral with a price target of $12, up from $9. Fennec ended Q3 with $29.8M in cash and equivalents, which Duncan believes will be sufficient to support Fennec through the early stages of the PEDMARK launch, although timing is a function of initial uptake and revenue recognition, the analyst tells investors in a research note. He thinks an injection of cash may be required to sufficiently build out its sales and marketing infrastructure and fully fund the early adoption of PEDMARK, and adds that Fennec took "several steps in the right direction" in Q3.