Full Press Release Details
Inc. Reports SECOND Quarter AND SIX MONTH 2022 Financial Results and Provides Business Update
Call Scheduled for Today at 8:30 a.m. Eastern Time
Heights, NJ - August 11, 2022 - CorMedix Inc. (Nasdaq: 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, 2022 and provided an update on recent business events.
Corporate Highlights:
Todisco, CorMedix CEO, commented, "While I am disappointed that we will not receive FDA approval on our PDUFA date, I remain confident
in our pathway forward to an FDA approval, once either our existing CMO and API supplier obtain compliance clearance, or we are able
to obtain regulatory approval for manufacturing with Alcami. We have sufficient cash on hand to fund operations through at least the
next four quarters, and the team is focused on obtaining FDA approval of the DefenCath NDA as quickly as possible. We look forward to
providing additional updates as we aim to deliver on our commitment to these patients."
Quarter and Six Month 2022 Financial Highlights
the second quarter 2022, CorMedix recorded a net loss of $7.6 million, or $0.19 per share, compared with a net loss of $4.6 million,
or $0.12 per share, in the second quarter of 2021, an increase of $3.0 million or 65%. The higher net loss recognized in 2022 compared
with 2021 included an increase in both SG&A expenses and R&D expenses versus the 2nd quarter of 2021. CorMedix recognized a tax
benefit of $0.6 million in the second quarter of 2022 from the sale of our NJ Net Operating Losses compared with a $1.3 million benefit
recorded in 2nd quarter of 2021.
expenses in the second quarter of 2022 increased approximately 41% to $8.3 million, compared with $5.9 million in the second quarter
of 2021. R&D expense increased approximately 28% to $3.2 million compared with $2.5 million in the second quarter of 2021, mainly
due to an increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased
approximately 50% to $5.1 million compared with $3.4 million in the second quarter of 2021. This increase was driven primarily by an
increase in in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval
of DefenCath, and an increase in legal fees mainly due to the securities litigation.
the six months ended June 30, 2022, CorMedix recorded a net loss of $14.6 million, or $0.38 per share, compared with a net loss of $11.8
million, or $0.32 per share, in the first half of 2021. Operating expenses in the first half of 2022 were $15.3 million, compared to
$13.1 million in the first half of 2021, an increase of approximately 17%. This increase was primarily due to costs related to the
manufacturing of DefenCath prior to its potential marketing approval, legal fees mainly due to the securities litigation, and personnel
Company reported cash and short-term investments of $64.6 million at June 30, 2022, excluding restricted cash. The Company believes that
it has sufficient resources to fund operations at least through the third quarter of 2023.
management team of CorMedix will host a conference call and webcast today, August 11, 2022, at 8:30AM Eastern Time, to discuss recent
corporate developments and financial results. Call details and dial-in information are as follows:
| Thursday, August 11 th @ 8:30am ET | ||
| Domestic: | 1-877-423-9813 | |
| International: | 1-201-689-8573 | |
| Conference ID: | 13730940 | |
| Webcast: | Webcast Link |
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, antibacterial
and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous
catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious
Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address
an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted
to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using
a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity
when the study is completed. The Company received a Complete Response Letter (CRL) from FDA stating that the original NDA could not be
approved until deficiencies at the contract manufacturing organization (CMO) were satisfactorily resolved. FDA notified the Company in
a second CRL that the refiled NDA could not be approved until satisfactory resolution of deficiencies identified during a pre-approval
inspection at the CMO and during an inspection for an unrelated active pharmaceutical ingredient at the manufacturing facility for the
heparin supplier for DefenCath. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations.
It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with 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. Neutrolin is CE Marked and marketed in Europe and other territories as a medical device. For more information,
visit: www.cormedix.com.
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations,
beliefs, goals, plans or CorMedix's prospects, CorMedix's plans to submit a resubmission of its NDA application for DefenCath
and the timing of such submission; CorMedix's plans regarding the submission of a duplicate NTAP and the timing of such submission,
future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned
that actual results may differ materially from projections or estimates due to a variety of important factors, including: the ability
of the CMO to address the deficiencies identified by the FDA; the ability of the Company's heparin supplier to address the manufacturing
deficiencies identified in the warning letter for non-heparin API; the resources needed to secure approval of the NDA for DefenCath from
the FDA; the risks and uncertainties of the relationships with the additional CMO and supplier of heparin; the ability to submit a supplement
to CorMedix's NDA by the end of the first quarter of 2023; the ability to secure final FDA approval prior to July 1, 2023 or obtain
CMS approval of a resubmitted NTAP application; the risks and uncertainties associated with CorMedix's ability to manage its limited
cash resources and the impact on current, planned or future research, including the continued development of DefenCath/Neutrolin and
research for additional uses for taurolidine; obtaining additional financing to support CorMedix's research and development and
clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated
in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. We
continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These
and other risks are described in greater detail in CorMedix's filings with the SEC, 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 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.
Inc. and SubsidiarIES
CONSOLIDATED STATEMENTS OF OPERATIONS
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Net sales | $ | 21,253 | $ | 8,191 | $ | 28,889 | $ | 96,451 | ||||||||
| Cost of sales | (332 | ) | (14,426 | ) | (1,859 | ) | (75,765 | ) | ||||||||
| Gross profit (loss) | 20,921 | (6,235 | ) | 27,030 | 20,686 | |||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | (3,209,471 | ) | (2,520,203 | ) | (5,497,058 | ) | (5,156,535 | ) | ||||||||
| Selling, general and administrative | (5,051,895 | ) | (3,355,790 | ) | (9,802,778 | ) | (7,956,896 | ) | ||||||||
| Total Operating Expenses | (8,261,366 | ) | (5,875,993 | ) | (15,299,836 | ) | (13,113,431 | ) | ||||||||
| Loss From Operations | (8,240,445 | ) | (5,882,228 | ) | (15,272,806 | ) | (13,092,745 | ) | ||||||||
| Other Income (Expense): | ||||||||||||||||
| Total Other Income (Expense) | 49,989 | (893 | ) | 48,156 | (7,314 | ) | ||||||||||
| Loss before income taxes | (8,190,456 | ) | (5,883,121 | ) | (15,224,650 | ) | (13,100,059 | ) | ||||||||
| Tax benefit | 585,617 | 1,250,186 | 585,617 | 1,250,186 | ||||||||||||
| Net Loss | (7,604,839 | ) | (4,632,935 | ) | (14,639,033 | ) | (11,849,873 | ) | ||||||||
| Other Comprehensive Income (Loss): | ||||||||||||||||
| Total Other Comprehensive Income (Loss) | (10,402 | ) | 355 | (47,611 | ) | (2,825 | ) | |||||||||
| Comprehensive Loss | $ | (7,615,241 | ) | $ | (4,632,580 | ) | $ | (14,686,644 | ) | $ | (11,852,698 | ) | ||||
| Net Loss Per Common Share - Basic and Diluted | $ | (0.19 | ) | $ | (0.12 | ) | $ | (0.38 | ) | $ | (0.32 | ) | ||||
| Weighted Average Common Shares Outstanding - Basic and Diluted | 39,761,754 | 38,083,842 | 39,008,590 | 37,211,233 |
INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEET DATA
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Cash, cash equivalents and restricted cash | $ | 49,153,417 | $ | 53,551,277 | ||||
| Short-term investments | $ | 15,692,548 | $ | 12,149,003 | ||||
| Total Assets | $ | 67,747,703 | $ | 68,945,576 | ||||
| Total Liabilities | $ | 6,008,963 | $ | 6,147,509 | ||||
| Accumulated deficit | $ | (260,298,114 | ) | $ | (245,659,081 | ) | ||
| Total Stockholders' Equity | $ | 61,738,740 | $ | 62,798,067 |
INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Six Month Periods Ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (14,639,033 | ) | $ | (11,849,873 | ) | ||
| Net cash used in operating activities | (12,206,457 | ) | (9,782,326 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Net cash used in investing activities | (3,593,220 | ) | (734,293 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Net cash provided by financing activities | 11,415,372 | 41,757,551 | ||||||
| Net (Decrease) Increase in Cash and Cash Equivalents | (4,397,860 | ) | 31,236,432 | |||||
| Cash and Cash Equivalents and Restricted Cash - Beginning of Period | 53,551,277 | 42,096,783 | ||||||
| Cash and Cash Equivalents and Restricted Cash - End of Period | $ | 49,153,417 | $ | 73,333,215 |