Cormedix Inc (CRMD) Reports Increased Operating Expenses Amid Pre-Launch Activities in Q3 2023
Net loss for Q3 2023 increased to $9.7 million, or $0.17 per share, compared to $6.9 million, or $0.17 per share in Q3 2022.
Operating expenses rose by approximately 50% in Q3 2023, driven by pre-launch commercial activities for DefenCath.
Cormedix Inc (NASDAQ:CRMD) believes it has sufficient resources to fund operations for at least twelve months from the filing date.
On November 14, 2023, Cormedix Inc (NASDAQ:CRMD) released its 8-K filing, detailing the financial results for the third quarter and nine months ended September 30, 2023, and providing a business update. The company, which is focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases, is currently preparing for the potential commercial launch of its lead product, DefenCath.
Financial Performance Overview
For Q3 2023, Cormedix Inc (NASDAQ:CRMD) reported a net loss of $9.7 million, or $0.17 per share, a notable increase from the net loss of $6.9 million, or $0.17 per share, in the same quarter of the previous year. This increase in net loss was primarily due to a rise in operating expenses, which jumped by approximately 50% to $10.5 million in Q3 2023, up from $7.0 million in Q3 2022. The company attributes this increase to intensified pre-launch commercial activities for DefenCath.
Research and Development (R&D) expenses saw an approximate 14% increase to $2.7 million in Q3 2023, compared to $2.3 million in the same period last year, mainly due to higher costs related to medical affairs activities and personnel expenses. Selling, General and Administrative (SG&A) expenses surged by approximately 69% to $7.8 million, up from $4.6 million in Q3 2022, driven by market research studies and pre-launch activities for DefenCath.
For the nine-month period ended September 30, 2023, the net loss widened to $31.6 million, or $0.65 per share, from $21.5 million, or $0.54 per share, in the first nine months of 2022. Operating expenses during this period increased by roughly 49% to $33.3 million, up from $22.3 million in the comparable period of 2022.
Liquidity and Capital Resources
As of September 30, 2023, Cormedix Inc (NASDAQ:CRMD) reported having $86.6 million in cash on hand and short-term investments, excluding restricted cash of $0.2 million. The company expressed confidence in its financial position, stating it has sufficient resources to fund operations for at least twelve months from the filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023.
Corporate Highlights and Future Outlook
Joe Todisco, CEO of Cormedix, expressed satisfaction with the company's progress, particularly with the outcomes of the preapproval inspections at their primary CMO facility and other key vendors. He emphasized the acceleration of work streams aimed at the commercial launch and the strategic hiring over the past quarter to ensure a successful launch, pending FDA approval of DefenCath. The company anticipates a response from the FDA around their target action date.
DefenCath, Cormedix Inc (NASDAQ:CRMD)'s lead product, is a non-antibiotic antimicrobial solution designed to prevent bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. The product has received Fast Track designation and has been recognized as a Qualified Infectious Disease Product (QIDP) by the FDA, which could grant additional marketing exclusivity upon approval.
While Cormedix Inc (NASDAQ:CRMD) prepares for the potential approval and launch of DefenCath, the company's financial results reflect the significant investment in these efforts. The increased operating expenses and net loss underscore the critical phase the company is in as it navigates the pre-approval and potential commercialization stages of its flagship product.
Explore the complete 8-K earnings release (here) from Cormedix Inc for further details.
This article first appeared on GuruFocus.
