BERKELEY HEIGHTS, N.J., Aug. 10, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced financial results for the second quarter and six months ended June 30, 2020 and provided an update on recent developments.
Recent Corporate and Regulatory Highlights:
- Completed an underwritten public offering of common stock, which yielded gross proceeds of approximately $23.0 million, including the full exercise of the underwriters’ option, or greenshoe.
- Completed the rolling submission and review of the New Drug Application for Defencath to the FDA for the prevention of catheter related blood stream infections, or CRBSIs, in patients undergoing hemodialysis via catheter. The submission is currently been assessed by FDA for completeness and acceptance for filing.
- Continued to expand our efforts to prepare for the commercial launch of Defencath. This includes ongoing dialogue with payors and providers, ongoing market research, and involvement with key advocacy organizations focused on kidney care.
- Cash and short-term investments, excluding restricted cash, at June 30, 2020 amounted to $22.4 million. Pro forma cash, including cash on the balance sheet at June 30, 2020 and the net proceeds from the recent financing, is approximately $43.9 million.
Khoso Baluch, CorMedix CEO commented, “We have made significant progress on our goal of bringing Defencath to the U.S. market as a catheter lock solution for hemodialysis. We were pleased to announce the completion of our rolling submission for Defencath last month and look forward to providing updates on the acceptance for filing from FDA. Despite the turbulence in the markets, we were excited to complete an institutional financing and broaden our investment banking relationships while doing so. We also are making necessary preparations for the launch of Defencath in the U.S. hemodialysis market, following FDA approval. We believe we have the team, the focus, and a therapy that will meaningfully improve patient outcomes and are excited about the opportunities in front of us.”
Second Quarter and Six Month 2020 Financial Highlights
For the second quarter 2020, CorMedix recorded a net loss of $3.8 million, or $0.14 per share, compared with a net loss of $0.7 million, or $0.03 per share, in the second quarter of 2019, an increase of $3.1 million. The higher net loss recognized in 2020 compared with 2019 was due to increased expenses related to our preparations for Defencath’s commercial launch. We recorded significant increases in both R&D and SG&A expenses. We recognized a tax benefit of $5.2 million in 2020 from the sale of our NJ Net Operating Losses compared with a $5.1 million benefit recorded in 2019.
Operating expenses in the second quarter of 2020 increased approximately 61% to $8.9 million, compared with $5.6 million in the second quarter of 2019. R&D expense increased approximately 91% to $5.7 million from $3.0 million, mainly due to a $3.4 million purchase of raw material that will be used in the production of Defencath for sale in the U.S. upon receipt of FDA marketing approval, partially offset by a 12% decrease in other R&D expenses. SG&A expense increased approximately 26% to $3.2 million compared with $2.6 million in the second quarter of 2019. Higher staffing, marketing and insurance expenses were primarily responsible for the increase, partially offset by reductions in several areas, particularly legal and accounting fees.
For the six months ended June 30, 2020, CorMedix recorded a net loss of $9.3 million, or $0.36 per share, compared with a net loss of $5.9 million, or $0.25 per share, in the first half of 2019, an increase of $3.4 million. Operating expenses in the first half of 2020 were $14.6 million, compared to $10.4 million in the first half of 2019, an increase of approximately 40%. This increase was due primarily to the raw material purchase in 2nd quarter and higher SG&A expenses throughout the organization.
Total cash on hand and short-term investments as of June 30, 2020 was $22.4 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at June 30, 2020, it has sufficient resources to fund operations at least twelve months after the filing date of its report on Form 10-Q, after taking into consideration the approximately $21.5 million in net proceeds from the equity financing that closed in July 2020.
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Defencath, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, currently in Phase 3 development for patients undergoing chronic hemodialysis. Such infections have significant treatment costs and lead to increased morbidity and mortality. Defencath has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provide the potential for priority review of a marketing application by FDA and allow for a total of ten years of market exclusivity in the event of U.S. approval. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels. The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information, visit: www.cormedix.com.
