CorMedix(CRMD)

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CorMedix(CRMD) - 2024 Q2 - Quarterly Results
2024-08-14 12:00
Exhibit 99.1 CORMEDIX INC. REPORTS SECOND QUARTER AND SIX MONTH 2024 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Conference Call Scheduled for Today at 8:30 a.m. Eastern Time Berkeley Heights, NJ – August 14, 2024 – 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 busi ...
CorMedix Inc. Reports Second Quarter and Six Month 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2024-08-14 11:30
BERKELEY HEIGHTS, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for lifethreatening 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 15th. The Company repor ...
CorMedix Inc. to Report Second Quarter 2024 Financial Results and Provide a Corporate Update on August 14, 2024
GlobeNewswire News Room· 2024-08-07 12:30
Core Insights - CorMedix Inc. is set to report its financial results for Q2 2024 on August 14, 2024, before market opening [1] - The company will host a corporate update conference call at 8:30 AM Eastern Time on the same day [1] Company Overview - CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases [2] - The company's lead product, DefenCath®, received FDA approval on November 15, 2023, and was commercially launched in inpatient settings in April 2024 and in outpatient settings in July 2024 [2] - CorMedix plans to develop DefenCath as a catheter lock solution for additional patient populations [2]
CorMedix Inc. Announces CMS Grants Pass-Through Status to Defencath
GlobeNewswire News Room· 2024-06-06 12:30
BERKELEY HEIGHTS, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for lifethreatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utiliz ...
CorMedix Inc. Announces CMS Grants Pass-Through Status to Defencath
Newsfilter· 2024-06-06 12:30
BERKELEY HEIGHTS, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for lifethreatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utiliz ...
CorMedix Inc. Announces Commercial Agreement With Top Tier Dialysis Provider
Newsfilter· 2024-05-28 12:30
BERKELEY HEIGHTS, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has entered into a multi-year commercial supply contract with a top tier midsized dialysis provider for the supply of DefenCath® (taurolidine and heparin). CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) ...
CorMedix Inc. Announces Commercial Agreement With Top Tier Dialysis Provider
globenewswire.com· 2024-05-28 12:30
Core Insights - CorMedix Inc. has entered into a multi-year commercial supply contract with a leading midsized dialysis provider for its product DefenCath® [1][2] - DefenCath® received NDA approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs on November 15, 2023, and began commercialization in inpatient settings on April 15, 2024, with plans to expand to outpatient dialysis clinics in July 2024 [2][3] - The agreement will provide access to DefenCath® at over 500 dialysis facilities nationwide, aiming to reduce catheter-related bloodstream infections for potentially thousands of patients [2][3] Company Overview - CorMedix Inc. is focused on developing and commercializing therapeutic products for life-threatening conditions, with a primary focus on DefenCath® [3] - The company aims to establish long-term relationships with dialysis providers committed to innovation and infection reduction [2][3] - Future plans include developing DefenCath® as a catheter lock solution for other patient populations [3]
CorMedix(CRMD) - 2024 Q1 - Earnings Call Transcript
2024-05-11 21:48
CorMedix Inc. (NASDAQ:CRMD) Q1 2024 Results Conference Call May 9, 2024 8:30 AM ET Company Participants Dan Ferry - LifeSci Advisors Joe Todisco - Chief Executive Officer Matt David - EVPr and CFO Beth Zelnick Kaufman - EVP and Chief Legal Officer Liz Hurlburt - EVP and Chief Clinical Strategy and Operations Officer Erin Mistry - EVP and Chief Commercial Officer Conference Call Participants Les Sulewski - Truist Securities Operator Good morning, and welcome to the CorMedix First Quarter 2024 Earnings Confer ...
CorMedix Inc. to Participate in Two Upcoming Investor Conferences
Globenewswire· 2024-05-10 12:30
BERKELEY HEIGHTS, N.J., May 10, 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 that management will be participating in fireside chats and investor meetings at both the JMP Securities Life Sciences Conference being held in New York on May 13 – 14, 2024 and the 2024 RBC Capital Markets Global Healthcare Conference being held in New York on May 14 – 1 ...
CorMedix(CRMD) - 2024 Q1 - Quarterly Report
2024-05-09 12:00
Part I Financial Information [Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) CorMedix reported an increased net loss in Q1 2024, driven by higher SG&A for DefenCath's launch, with total assets decreasing to **$68.0 million** Condensed Consolidated Balance Sheet Data (Unaudited) | Account | March 31, 2024 ($) | December 31, 2023 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $35,180,529 | $43,642,684 | | Short-term investments | $23,370,989 | $32,388,130 | | Inventories | $2,320,396 | $2,106,345 | | License intangible asset | $2,000,000 | $0 | | **Total Assets** | **$68,023,742** | **$82,059,957** | | **Liabilities & Equity** | | | | Total Liabilities | $10,011,022 | $11,917,528 | | Total Stockholders' Equity | $58,012,720 | $70,142,429 | | **Total Liabilities and Stockholders' Equity** | **$68,023,742** | **$82,059,957** | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended Mar 31, 2024 (in thousands) | Three Months Ended Mar 31, 2023 (in thousands) | | :--- | :--- | :--- | | Revenues, net | $0 | $0 | | Gross loss | ($819) | $0 | | Research and development | ($837) | ($3,407) | | Selling, general and administrative | ($15,048) | ($7,610) | | Loss From Operations | ($16,704) | ($11,017) | | Net Loss | **($14,466)** | **($10,567)** | | Net Loss Per Common Share | **($0.25)** | **($0.24)** | Condensed Consolidated Statements of Cash Flows (Unaudited) | Activity | Three Months Ended Mar 31, 2024 (in thousands) | Three Months Ended Mar 31, 2023 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,310) | ($10,394) | | Net cash provided by (used in) investing activities | $8,945 | ($14,687) | | Net cash (used in) provided by financing activities | ($97) | $7,200 | | **Net Decrease in Cash and Cash Equivalents** | **($8,463)** | **($17,878)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) CorMedix focuses on DefenCath's U.S. commercialization, with Q1 2024 net loss increasing due to higher SG&A, partially offset by decreased R&D [Overview](index=24&type=section&id=Overview) CorMedix is commercializing DefenCath, an FDA-approved antimicrobial catheter lock solution with marketing exclusivity, launched for inpatient use in April 2024 - The FDA approved DefenCath on **November 15, 2023**, as the first and only FDA-approved antimicrobial CLS in the U.S. to reduce CRBSI in adult hemodialysis patients[96](index=96&type=chunk) - DefenCath received **10 years of marketing exclusivity** (5 years NCE, 5 years GAIN Act) until **November 15, 2033**[97](index=97&type=chunk) - CMS approved a Transitional Drug Add-On Payment (TDAPA) for DefenCath, effective **July 1, 2024**, providing **five years** of additional outpatient reimbursement[108](index=108&type=chunk)[99](index=99&type=chunk) - The U.S. commercial launch for inpatient use of DefenCath began on **April 15, 2024**, with the first commercial supply contract signed with ARC Dialysis, LLC[107](index=107&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) CorMedix's Q1 2024 net loss increased to **$14.5 million** due to a **97%** rise in SG&A for DefenCath's launch, partially offset by a **75%** decrease in R&D expenses Comparison of Operating Results (in thousands) | Account | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Gross loss | ($819) | $0 | N/A | | Research and development | ($838) | ($3,407) | (75)% | | Selling, general and administrative | ($15,048) | ($7,610) | 98% | | **Loss from operations** | **($16,705)** | **($11,017)** | **52%** | | **Net loss** | **($14,467)** | **($10,568)** | **37%** | - SG&A expenses increased by **$7.4 million (97%)** year-over-year, driven by **$3.8 million** in personnel costs and **$2.7 million** for market research and launch activities[122](index=122&type=chunk) - R&D expenses decreased by **$2.6 million (75%)** year-over-year, primarily due to reclassification of costs to SG&A and capitalization of manufacturing expenses post-FDA approval[121](index=121&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2024, CorMedix held **$58.6 million** in cash and investments, sufficient for at least twelve months of operations, despite increased cash usage for Q1 2024 operating activities - The company's **$58.6 million** in cash, cash equivalents, and short-term investments as of **March 31, 2024**, are estimated to fund operations for at least **twelve months**[132](index=132&type=chunk)[136](index=136&type=chunk) - Net cash used in operating activities increased to **$17.3 million** in Q1 2024 from **$10.4 million** in Q1 2023, driven by a higher net loss and increased working capital for the commercial launch[129](index=129&type=chunk) - In **March 2024**, the company received **$1.4 million** from the sale of its New Jersey net operating losses (NOLs)[128](index=128&type=chunk) - The company expects to implement an ATM program and may seek additional capital through equity or debt financing to support ongoing funding requirements[134](index=134&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a Smaller Reporting Company, CorMedix is not required to provide quantitative and qualitative disclosures about market risk - As a Smaller Reporting Company, CorMedix is not required to provide information regarding quantitative and qualitative disclosures about market risk[141](index=141&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of **March 31, 2024**[142](index=142&type=chunk) - No material changes occurred during the quarter affecting the company's internal control over financial reporting[143](index=143&type=chunk) Part II Other Information [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is defending against a consolidated securities class action and a shareholder derivative lawsuit, both related to DefenCath NDA statements and fiduciary duties - The company is defending a securities class action lawsuit (In re CorMedix Inc. Securities Litigation) alleging violations related to DefenCath NDA statements, with a third amended complaint filed in **April 2024**[54](index=54&type=chunk)[145](index=145&type=chunk) - A consolidated shareholder derivative action (In re CorMedix Inc. Derivative Litigation) alleging breaches of fiduciary duty is stayed pending the class action lawsuit's motion to dismiss[55](index=55&type=chunk)[58](index=58&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) No material changes occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2023 - No material changes occurred from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended **December 31, 2023**[146](index=146&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report during the period - None[147](index=147&type=chunk) [Exhibits](index=34&type=section&id=Item%206.%20Exhibits) The report includes standard filings such as CEO and CFO certifications under Sarbanes-Oxley Act and Inline XBRL data files - Exhibits include certifications from the Principal Executive Officer and Principal Financial Officer under Sections 302 and 906 of the Sarbanes-Oxley Act, along with Inline XBRL documents[153](index=153&type=chunk)