CorMedix Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Rhea-AI Summary

CorMedix Inc. (CRMD) announces FDA approval for DefenCath, a catheter lock solution to reduce infections in kidney failure patients on hemodialysis. The company is preparing for commercial launch and has a strong financial position with $76.0 million in cash and short-term investments.

Insights

Financial Analyst

The FDA approval of CorMedix's DefenCath represents a significant milestone for the company, with the potential to drive future revenue growth. The product addresses a critical need in the prevention of catheter-related bloodstream infections (CRBSIs) in a specific patient population, which could lead to a competitive advantage in the niche market of kidney failure treatments. The receipt of outpatient reimbursement determination from CMS is another key factor that can significantly impact CorMedix's profitability. Reimbursement pathways are crucial for the adoption of new medical treatments and the Transitional Drug Add-on Payment (TDAPA) under the ESRD PPS enhances the financial viability of DefenCath in the market.

CorMedix's preparations for the commercial launch and the expansion of inventory production suggest a proactive approach to market penetration. However, investors should monitor the company's cash burn rate against its current cash reserves of $76.0 million, as ramping up operations can lead to increased expenditures. The planned commercialization in the inpatient setting and the pending CMS review for TDAPA implementation are short-term catalysts that investors should watch closely. The company's ability to manage these milestones effectively will likely influence its stock performance in the upcoming quarters.

Market Research Analyst

The market for CRBSI prevention is growing, driven by the increasing prevalence of chronic illnesses requiring long-term treatments such as hemodialysis. CorMedix's DefenCath targets a specific, yet significant, market segment of adult patients with kidney failure, which can be seen as a strategic move to capture niche market share. The company's strategy to establish field sales and medical affairs organizations indicates an understanding of the importance of strong market engagement and education for the successful adoption of DefenCath.

The potential mid-year meeting with the FDA to discuss an expanded label for DefenCath could open additional market opportunities, but it is essential to consider the timeline and regulatory hurdles that may affect the product's broader market access. Furthermore, the company's focus on securing an alternate manufacturing site for finished dosage is a strategic step to mitigate supply chain risks and ensure product availability to meet anticipated demand. The market will be looking for evidence of successful execution of these strategies as indicators of CorMedix's long-term growth potential.

Medical Research Analyst

DefenCath's approval by the FDA is an important development in the field of infection control within hemodialysis treatment. The clinical significance of reducing CRBSIs cannot be understated, as these infections are associated with high morbidity and mortality rates among patients with central venous catheters. CorMedix's product could potentially improve patient outcomes and reduce healthcare costs associated with treating these infections.

The company's ongoing dialogue with the FDA regarding an expanded label suggests a commitment to further clinical development and potentially broadening the patient base that could benefit from DefenCath. The success of these efforts will depend on the outcomes of clinical studies and the FDA's assessment of the product's safety and efficacy in a wider population. From a medical research perspective, the impact of DefenCath on patient care and the healthcare system will be closely monitored through post-marketing studies and real-world evidence.

Conference Call Scheduled for Today at 8:30 a.m. Eastern Time

BERKELEY HEIGHTS, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on its business.

Recent Corporate Highlights:

• On November 15, 2023, CorMedix received FDA approval for its new drug application (NDA) for DefenCath® (taurolidine and heparin). DefenCath is a catheter lock solution indicated to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).
• The Company received an outpatient reimbursement determination for DefenCath from the Center for Medicare & Medicaid Services (CMS), which confirmed that DefenCath is eligible to receive a Transitional Drug Add-on Payment, or TDAPA, under the End Stage Renal Disease Prospective Payment System (ESRD PPS). CorMedix’s TDAPA application remains under review, and CMS has confirmed that it is working toward a July 1^st effective implementation for TDAPA. Pending a timely implementation of TDAPA, CorMedix intends to launch in the outpatient setting in July 2024.
• CorMedix has intensified preparations for commercial launch, has staffed and trained experienced field sales and medical affairs organizations, and remains on schedule to begin commercialization in the inpatient setting on April 15, 2024.
• The Company is in the process of ramping up inventory production to meet anticipated demand, and remains on track to file with the FDA a supplement to the DefenCath NDA adding an alternate manufacturing site for finished dosage in April.
• CorMedix is targeting by the end of the first quarter to submit a post-approval meeting request to FDA with the objective of aligning with the agency on a clinical pathway for an expanded label at a proposed mid-year meeting.
• Cash and short-term investments, excluding restricted cash, at December 31, 2023 amounted to $76.0 million.

Joe Todisco, CorMedix CEO, commented, “I am excited about the Company’s recent progress as we have scaled up activity ahead of our commercial launch in April. We have received significant inbound interest from both inpatient facilities as well as outpatient dialysis providers with respect to DefenCath, and we are actively engaged in customer discussions in both settings of care. I remain optimistic about the commercial potential for DefenCath, and the product’s ability to have a meaningful impact on CRBSI rates across the continuum of care in hemodialysis patients with CVCs.”

4^th Quarter and Full Year 2023 Financial Highlights

For the fourth quarter of 2023, CorMedix recorded a net loss of $14.8 million, or $0.26 per share, compared with a net loss of $8.2 million, or $0.20 per share, in the fourth quarter of 2022. The increase in net loss in the fourth quarter of 2023 compared with 2022 was primarily driven by increases in costs related to market research studies and pre-launch activities for DefenCath and increases in personnel expenses due to new hires in 2023 compared to the same period in 2022. Operating expenses during the fourth quarter of 2023 were $15.7 million, compared with $8.4 million in the fourth quarter of 2022, an increase of approximately $7.3 million.   

For the year ended December 31, 2023, CorMedix recorded a net loss of $46.3 million, or $0.91 per share, compared with a net loss during the year ended December 31, 2022 of $29.7 million, or $0.74 per share. The increase in net loss was driven primarily by increases in operating expenses, primarily due to increased pre-launch commercial activities for DefenCath.

Operating expenses during the year ended December 31, 2023 amounted to $49.0 million compared with $30.7 million during the comparable period in 2022, an increase of $18.3 million, or 60%, due to a 79% increase and 23% increase in SG&A expense and R&D expense, respectively.

Total cash on hand, cash equivalents and short-term investments as of December 31, 2023 amounted to $76.0 million, excluding restricted cash of $0.2 million. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of its Annual Report on Form 10-K.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, March 12, 2023, at 8:30 AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

Tuesday, March 12^th @ 8:30am ET

Domestic:         International:  Conference ID: Webcast:

1-888-886-7786 1-416-764-8658 08695074 Webcast Link

DefenCath® (taurolidine and heparin)
IMPORTANT SAFETY INFORMATION

This brief summary does not include all the information needed to use DefenCath safely and effectively. Please see the full Prescribing Information for more information.

LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

DefenCath is contraindicated and has warnings and precautions in patients with:

• Known heparin-induced thrombocytopenia (HIT).
• Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.

If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.

The most frequently reported adverse reactions occurring in ≥2% of patients using DefenCath as a CLS were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.

 To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath®, a non-antibiotic, antimicrobial catheter lock solution approved to reduce the incidence of catheter-related bloodstream infections in the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter. DefenCath was approved by the FDA on November 15, 2023. CorMedix anticipates the commercial launch of DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024, pending a timely implementation of TDAPA. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, including, but not limited to, statements regarding the commercial launch of DefenCath, the timing of availability of DefenCath for inpatient and outpatient settings, DefenCath receipt of TDAPA, CMS implementation of TDAPA in July 2024, the interest in DefenCath by health systems, the ability to manufacture sufficient DefenCath for commercial launch, CorMedix’s future financial position, financing plans, future revenues, projected costs and the sufficiency of our cash and short-term investments to fund our operations, including the commercial launch of DefenCath, should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576

CORMEDIX INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (Audited)
		For the Three Months Ended December 31,								For the Years Ended December 31,
		2023				2022				2023				2022
Revenue:
Net sales	$	-			$	29,702			$	-			$	65,408
Cost of sales		-				(406	)			-				(3,734	)
Gross profit (loss)		-				29,296				-				61,674
Operating Expenses:
Research and development		(2,288,889	)			(2,843,222	)			(13,155,125	)			(10,679,549	)
Selling, general and administrative		(13,379,854	)			(5,575,302	)			(35,802,663	)			(20,006,093	)
Total Operating Expenses		(15,668,743	)			(8,418,524	)			(48,957,788	)			(30,685,642	)
Income (loss) From Operations		(15,668,743	)			(8,389,228	)			(48,957,788	)			(30,623,968	)
Other Income (Expense):
Interest income		920,042				183,506				2,681,851				326,016
Foreign exchange transaction gain (loss)		1,227				5,547				(28,994	)			37,145
Interest expense		(6,556	)			(8,776	)			(34,296	)			(26,515	)
Total Other Income (Expense)		914,713				180,277				2,618,561				336,646
Net Loss Before Income Taxes		(14,754,030	)			(8,208,951	)			(46,339,227	)			(30,287,322	)
Tax benefit		-				-				-				585,617
Net Loss		(14,754,030	)			(8,208,951	)			(46,339,227	)			(29,701,705	)
Other Comprehensive Income (Loss)		9,710				36,971				11,365				(4,387	)
Comprehensive Loss	$	(14,744,320	)		$	(8,171,980	)		$	(46,327,862	)		$	(29,706,092	)
Net Income (Loss) Per Common Share – Basic and Diluted	$	(0.26	)		$	(0.20	)		$	(0.91	)		$	(0.74	)
Weighted Average Common Shares Outstanding – Basic and Diluted		57,393,542				41,855,056				50,902,931				40,274,273

CORMEDIX INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (Audited)
		December 31,				December 31,
		2023				2022
ASSETS
Cash, cash equivalents and restricted cash	$	43,823,192			$	43,374,745
Short-term investments	$	32,388,130			$	15,644,062
Total Assets	$	82,059,957			$	62,038,259
Total Liabilities	$	11,917,528			$	6,978,523
Accumulated deficit	$	(321,700,013	)		$	(275,360,786	)
Total Stockholders’ Equity	$	70,142,429			$	55,059,736

CORMEDIX INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (Audited)
	Years Ended December 31,
	2023				2022
Cash Flows From Operating Activities:
Net loss	$	(46,339,227	)		$	(29,701,705	)
Net cash used in operating activities		(38,409,480	)			(24,356,732	)
Cash Flows From Investing Activities:
Net cash used in investing activities		(17,061,685	)			(3,709,364	)
Cash Flows From Financing Activities:
Net cash provided by financing activities		55,916,804				17,898,241
Foreign exchange effects on cash		2,808				(8,677	)
Net Increase (Decrease) in Cash and Cash Equivalents		448,447				(10,176,532	)
Cash and Cash Equivalents and Restricted Cash - Beginning of Period		43,374,745				53,551,277
Cash and Cash Equivalents and Restricted Cash - End of Period	$	43,823,192			$	43,374,745

FAQ

What drug received FDA approval from CorMedix?

DefenCath (taurolidine and heparin) received FDA approval from CorMedix.

What is DefenCath indicated for?

DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter.

When does CorMedix plan to launch DefenCath in the outpatient setting?

CorMedix intends to launch DefenCath in the outpatient setting in July 2024 pending a timely implementation of TDAPA.

How much cash and short-term investments did CorMedix have at the end of December 31, 2023?

CorMedix had $76.0 million in cash and short-term investments at the end of December 31, 2023.