CorMedix Inc. Reports Second Quarter and Six Month 2024 Financial Results and Provides Business Update

Rhea-AI Summary

CorMedix Inc. (NASDAQ: CRMD) reported Q2 and H1 2024 financial results and provided a business update. Key highlights include:

- Initial net sales of $0.8 million for Q2 2024, primarily from inpatient trade stocking

- Unaudited Q3 quarter-to-date net sales of $5.2 million as of August 13th, driven by outpatient setting orders

- Cash and short-term investments of $45.6 million as of June 30, 2024

- Net loss of $14.2 million ($0.25 per share) for Q2 2024, compared to $11.3 million ($0.25 per share) in Q2 2023

- Operating expenses increased 32% to $15.6 million in Q2 2024

- Company believes it has sufficient resources to fund operations for at least 12 months

Positive

• Initial net sales of $0.8 million for Q2 2024, marking the start of DefenCath commercialization
• Strong Q3 quarter-to-date net sales of $5.2 million as of August 13th
• Successful launch of DefenCath in both inpatient and outpatient settings
• Over 95% pull-through to clinic level for outpatient shipments
• Potential expansion of DefenCath indications beyond adult hemodialysis

Negative

• Net loss increased by 26% to $14.2 million in Q2 2024 compared to Q2 2023
• Operating expenses increased by 32% to $15.6 million in Q2 2024
• Cash and short-term investments decreased to $45.6 million as of June 30, 2024

Insights

Financial Analyst

CorMedix's Q2 2024 results show promising early signs for DefenCath's commercial launch. Net sales of $0.8 million for Q2 primarily from inpatient trade stocking, with unaudited Q3-to-date net sales of $5.2 million driven by outpatient orders, indicate growing market traction. The 95% verified pull-through to clinic level for outpatient shipments is particularly encouraging.

However, the company's net loss increased by 26% to $14.2 million in Q2 2024 compared to Q2 2023. This was mainly due to higher S&M and G&A expenses related to the commercial launch. With cash and short-term investments of $45.6 million, the company appears well-positioned to fund operations for at least 12 months, but investors should monitor the burn rate closely as commercial activities ramp up.

Medical Research Analyst

The launch of DefenCath in both inpatient and outpatient settings marks a significant milestone for CorMedix. The product's potential to reduce bloodstream infections in hemodialysis patients addresses a critical medical need. The company's plans to expand DefenCath's indications, particularly for adult Total Parenteral Nutrition (TPN), could substantially broaden its market reach.

The FDA's supportive feedback on the clinical pathway for TPN and the anticipated start of patient enrollment in Q1 2025 are positive developments. This expansion could position DefenCath as a versatile solution for preventing catheter-related bloodstream infections across multiple patient populations, potentially driving long-term growth for CorMedix.

Market Research Analyst

CorMedix's commercial strategy appears to be gaining traction, with initial sales driven by small and mid-size dialysis operators. The ongoing discussions with dialysis providers across the spectrum suggest potential for further market penetration. However, investors should note that the inpatient setting may see a slower adoption curve due to the P&T formulary review process.

The shift in expense allocation from R&D to S&M and G&A reflects the company's transition from development to commercialization. While this has led to increased short-term losses, it's a necessary investment for long-term revenue growth. The key metrics to watch in coming quarters will be the rate of formulary approvals, expansion of the customer base and the trajectory of sales growth relative to operating expenses.

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

BERKELEY HEIGHTS, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the second quarter and six months ended June 30, 2024 and provided an update on its business.

Recent Corporate Highlights:

• CorMedix today reports our initial partial quarter of sales since DefenCath’s inpatient launch on April 15^th. The Company reported net sales of $0.8 million for the second quarter, which primarily represents trade stocking for inpatient facilities. The company has started to see pull-through of units to inpatient facilities in the third quarter, and expects that pace to accelerate over the coming months as DefenCath begins to obtain formulary clearance following health system P&T reviews.
• In early July 2024, CorMedix launched DefenCath in the outpatient setting. The Company today reports unaudited quarter-to-date net sales of $5.2 million, as of August 13^th. Initial sales in the outpatient setting have been driven by orders from small and mid-size dialysis operators, and the company has verified pull-through to the clinic level for more than 95% of these shipments.
• CorMedix continues discussions with dialysis providers across the spectrum for the implementation of DefenCath and the Company remains optimistic regarding additional commercial supply agreements as the launch proceeds.
• CorMedix announced last quarter that the Company received supportive feedback from FDA related to our proposed clinical pathway for adult Total Parenteral Nutrition, or TPN, subject to the agency’s review of our final study protocol. CorMedix has submitted the study protocol to FDA and anticipates commencing patient enrollment in the first quarter of 2025.
• Cash and short-term investments, excluding restricted cash, at June 30, 2024 amounted to $45.6 million.
  

Joe Todisco, CorMedix CEO, commented, “I am excited about the Company’s recent progress as we have now launched DefenCath in both the inpatient and outpatient settings. I’m very pleased with the early revenue trajectory from our outpatient launch, as well as the progress we are making on the inpatient P&T formulary process. We have also set the stage for expanded indications for the DefenCath technology, which we believe can have a meaningful impact on bloodstream infection rates in new patient populations beyond adult hemodialysis.”

Second Quarter and Six Months 2024 Financial Highlights

For the second quarter of 2024, CorMedix recorded a net loss of $14.2 million, or $0.25 per share, compared with a net loss of $11.3 million, or $0.25 per share, in the second quarter of 2023, an increase of $2.9 million or 26%, driven primarily by an increase in operating expenses.

Operating expenses in the second quarter 2024 were $15.6 million, compared with $11.8 million in the second quarter of 2023, an increase of approximately 32%. The increase was driven by higher S&M and G&A expenses which increased approximately $4.1 million or 127% and $3.8 million or 101%, respectively. These increases were partially offset by a decrease in research and development expenses of approximately $4.1 million or 86%. The increases in S&M and G&A were primarily driven by increased marketing efforts and the hiring of sales force, medical affairs and marketing personnel in support of the commercial launch of DefenCath. Additionally, as a result of the post FDA approval commercial operations, costs related to medical affairs and certain personnel expenses that supported R&D efforts prior to the FDA approval of DefenCath have been recognized primarily in G&A expense during the three months ended June 30, 2024, as compared to the same period last year during which these items were recognized in R&D, which drove the decrease in R&D expenses for this period compared to the same period last year.

For the six months ended June 30, 2024, CorMedix recorded a net loss of $28.6 million, or $0.50 per share, compared with a net loss of $21.8 million, or $0.49 per share, in the same period in 2023, an increase of $6.8 million or 31%, driven primarily by an increase in operating expenses, partially offset by the proceeds received from the sale of our unused New Jersey net operating losses. Operating expenses in the first half of 2024 were $31.5 million, compared to $22.8 million in the first half of 2023, an increase of approximately $8.7 million or 38%. This increase was primarily due to costs related to marketing and commercial activities in support of the launch activities of DefenCath, offset by a decrease in R&D expenses, driven by the marketing approval of DefenCath.

The Company reported cash and short-term investments of $45.6 million at June 30, 2024, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, August 14, 2024, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

Wednesday, August 14ᵗʰ@ 8:30am ET
Domestic:	1-877-270-2148
International:	1-412-902-6510
Webcast:	Webcast Link

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^®, which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. 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 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
daniel@lifesciadvisors.com
(617) 430-7576

CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(Unaudited)
	For the Three Months Ended June 30,							For the Six Months Ended June 30,
		2024			2023			2024			2023
Revenue
Revenue, net	$	806,119		$	-		$	806,119		$	-
Cost of revenues		(509,839)			-			(1,328,377)			-
Gross profit (loss)		296,280			-			(522,258)			-
Operating Expenses
Research and development		(650,988)			(4,794,758)			(1,488,432)			(8,202,260)
Selling and marketing		(7,386,841)			(3,256,047)			(13,724,061)			(5,897,223)
General and administrative		(7,559,277)			(3,753,777)			(16,270,310)			(8,722,278)
Total operating expenses		(15,597,106)			(11,804,582)			(31,482,803)			(22,821,761)
Loss from Operations		(15,300,826)			(11,804,582)			(32,005,061)			(22,821,761)
Other Income (Expense)
Total other income		1,149,337			530,964			1,992,679			980,917
Net Loss Before Income Taxes		(14,151,489)			(11,273,618)			(30,012,382)			(21,840,844)
Tax benefit		-			-			1,394,770			-
Net Loss		(14,151,489)			(11,273,618)			(28,617,612)			(21,840,844)
Other Comprehensive Income (Loss)
Total other comprehensive income (loss)		2,270			(10,535)			(8,377)			7,954
Other Comprehensive (Loss) Income	$	(14,149,219)		$	(11,284,153)		$	(28,625,989)		$	(21,832,890)
Net Loss Per Common Share – Basic and Diluted	$	(0.25)		$	(0.25)		$	(0.50)		$	(0.49)
Weighted Average Common Shares
Outstanding – Basic and Diluted		57,620,974			45,365,635			57,562,064			44,731,838

CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEET DATA
		June 30,			December 31,
		2024			2023
		(Unaudited)			(Audited)
ASSETS
Cash, cash equivalents and restricted cash	$	28,645,059		$	43,823,192
Short-term investments	$	17,069,660		$	32,388,130
Total Assets	$	57,730,594		$	82,059,957
Total Liabilities	$	11,546,663		$	11,917,528
Accumulated deficit	$	(350,317,625)		$	(321,700,013)
Total Stockholders’ Equity	$	46,183,931		$	70,142,429

CORMEDIX INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
	For the Six Months Ended June 30,
	2024				2023
Cash Flows from Operating Activities:
Net loss	$	(28,617,612)			$	(21,840,844)
Net cash used in operating activities		(31,350,210)				(18,966,316)
Cash Flows Used in Investing Activities:
Net cash provided by (used in) investing activities		15,213,503				(17,072,611)
Cash Flows from Financing Activities:
Net cash provided by financing activities		959,467				12,550,623
Net Decrease in Cash and Cash Equivalents		(15,178,133)				(23,485,773)
Cash and Cash Equivalents and Restricted Cash - Beginning of Period		43,823,192				43,374,745
Cash and Cash Equivalents and Restricted Cash - End of Period	$	28,645,059			$	19,888,972

FAQ

What were CorMedix's (CRMD) Q2 2024 net sales?

CorMedix reported net sales of $0.8 million for Q2 2024, primarily representing trade stocking for inpatient facilities.

How much are CorMedix's (CRMD) Q3 2024 quarter-to-date net sales?

CorMedix reported unaudited Q3 quarter-to-date net sales of $5.2 million as of August 13, 2024.

What was CorMedix's (CRMD) net loss for Q2 2024?

CorMedix recorded a net loss of $14.2 million, or $0.25 per share, for Q2 2024.

When did CorMedix (CRMD) launch DefenCath in the outpatient setting?

CorMedix launched DefenCath in the outpatient setting in early July 2024.