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CORMEDIX INC. REPORTS fourth QUARTER and full year 2019 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Company in process of submitting New Drug Application (NDA) for Neutrolin for prevention of catheter-related blood st

Key Takeaway: INC. REPORTS fourth QUARTER and full year 2019 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE in process of submitting New Drug Application (NDA) for Neutrolin for prevention of catheter-related blood stream infections via a rolling review granted by FDA Call Scheduled for Tod

Full Press Release Details

INC. REPORTS fourth QUARTER and full year 2019 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
in process of submitting New Drug Application (NDA) for Neutrolin for prevention of catheter-related blood stream infections
via a rolling review granted by FDA
Call Scheduled for Today at 4:30 p.m. Eastern Time
NJ - March 16, 2020 - 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 fourth quarter and full year ended December 31, 2019 and provided an update on recent business developments.
Recent Corporate Highlights:
CorMedix CEO commented, "We are very pleased to have received FDA agreement to submit our NDA on a rolling basis, and to
have commenced the submission process as a result. We plan to continue our filing schedule and to be on track for a decision in
the second half of 2020, although we cannot at this time anticipate the impact on our timetable of the FDA's postponement
of most foreign inspections. We will continue the NDA submission process along our planned timeline and will provide material updates
as they become available."
4th Quarter 2019 Financial
quarter of 2019, CorMedix recorded a net loss attributable to common shareholders of $5.3 million, or $0.21 per share, compared
with a net income of $2.2 million, or $0.10 per share, in the fourth quarter of 2018, an increase in net loss of $7.5 million.
The increase in net loss in the fourth quarter 2019 compared with the gain in the fourth quarter of 2018 was driven primarily by
the reversal of clinical trial expenses as a result of the settlement agreement with our CRO in 2018. Operating expenses during
the fourth quarter of 2019 were $5.4 million, compared with a gain of $2.1 million in the fourth quarter of 2018, an increase of
approximately $7.5 million.
Financial Highlights
December 31, 2019, CorMedix recorded a net loss attributable to common shareholders of $43.5 million, or $1.80 per share, compared
with a net loss of $26.8 million, or $1.51 per share, an increase of $16.7 million. The increase in net loss was driven primarily
by the deemed dividends recognized as a result of the exchange agreement and modification of certain warrants totaling $27.1 million
for the year ended December 31, 2019, partially offset by decreased clinical trial expense of $9.7 million. The net loss before
recognition of the deemed dividends during the year ended December 31, 2019 was $16.4 million.
during the year ended December 31, 2019 amounted to $20.9 million compared with $26.9 million during the comparable period in 2018,
a reduction of $6.0 million, or 22%, due to a 41% reduction in R&D expense partially offset by a 22% increase in SG&A.
hand and short-term investments as of December 31, 2019 amounted to $28.3 million, excluding restricted cash of $0.2 million. The
Company believes that, based on the Company's cash resources at year end plus the $2.5 million of ATM proceeds received since
the beginning of 2020 and the $0.4 million net proceeds from the exercise of warrants, it has sufficient resources to fund operations
into the second quarter of 2021, including the submission of the NDA for Neutrolin and initial preparations for commercial launch.
Conference Call Information
team of CorMedix will host a conference call and webcast today, March 16, 2020, at 4:30 PM Eastern Time, to discuss recent corporate
developments and financial results. Call details and dial-in information is as follows:
Domestic: 877-423-9813
International: 201-689-8573
Passcode: 13698818
Webcast: http://public.viavid.com/ index.php?id=137974
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 Neutrolin , a novel, non-antibiotic antimicrobial
solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters.
The Company recently completed a Phase 3 clinical trial of Neutrolin in patients undergoing
chronic hemodialysis, which showed a 71% reduction in catheter-related bloodstream infections (CRBSIs)
relative to the heparin control arm (p=0.0006) with a good safety profile. Such infections cost the U.S. healthcare system approximately
$6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status
and is designated as a Qualified Infectious Disease Product, which provides the potential
for priority review of a marketing application by FDA and allows for 5
additional years of QIDP 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.
Forward-Looking Statements
This 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, 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 results of our discussions with the FDA regarding the Neutrolin development path, including
whether a second Phase 3 clinical trial for Neutrolin will be required; the resources needed to complete the information required
to submit a new drug application for Neutrolin to the FDA; 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 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. At this time, we are unable to assess whether, and 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.
CORMEDIX INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE INCOME (LOSS)
For the Three Months Ended December 31, For the Years Ended December 31,
2019 2018 2019 2018
Revenue:
Net sales $ 24,779 $ 26,523 $ 283,266 $ 429,797
Cost of sales (46,125 ) (22,113 ) (373,234 ) (396,786 )
Gross profit (21,346 ) 4,410 (89,968 ) 33,011
Operating Expenses:
Research and development (2,677,007 ) 4,347,262 (11,052,903 ) (18,822,488 )
Selling, general and administrative (2,678,231 ) (2,213,441 ) (9,865,005 ) (8,074,719 )
Total Operating Expenses (5,355,238 ) 2,133,821 (20,917,908 ) (26,897,207 )
Income (loss) From Operations (5,376,584 ) 2,138,230 (21,007,876 ) (26,864,196 )
Other Income (Expense):
Interest income 75,788 6,235 322,668 36,618
Foreign exchange transaction loss 2,126 4,052 (21,156 ) (179 )
Change in fair value of derivative liability - - - -
Interest and amortization expense (6,276 ) - (787,488 ) (1,873 )
Total Other Income (Expense) 71,638 10,287 (485,976 34,566
Net Loss Before Income Taxes (5,304,946 ) 2,148,518 (21,493,852 ) (26,829,630 )
Tax benefit - - 5,060,778 -
Net Loss (5,304,946 ) 2,148,518 (16,433,074 ) (26,829,630 )
Other Comprehensive Income (Loss) (3,308 ) 5,524 735 (1,911 )
Comprehensive Income (Loss) $ (5,308,254 ) $ 2,154,041 $ (16,432,339 ) $ (26,831,541 )
Net loss (5,304,946 ) 2,148,518 (16,433,074 ) (26,829,630 )
Deemed dividend as a result of warrant modification - - (369,500 ) -
Deemed dividend as a result of exchange of convertible note and Series C-2, Series D and Series F preferred stock, related party - - (26,733,098 ) -
Net Loss Attributable to Common Shareholders (5,304,946 ) 2,148,518 (43,535,672 ) (26,829,630 )
Net Income (Loss) Per Common Share - Basic and Diluted $ (0.21 ) $ 0.10 $ (1.80 ) $ (1.51 )
Weighted Average Common Shares Outstanding - Basic and Diluted 25,665,619 20,880,195 24,152,088 17,816,624
CORMEDIX INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
December 31, December 31,
2019 2018
ASSETS
Cash, cash equivalents and restricted cash $ 16,525,187 $ 17,795,323
Short-term investments $ 11,984,157 $ -
Total Assets $ 29,475,910 $ 18,825,914
Total Liabilities $ 5,829,650 $ 13,891,658
Accumulated deficit $ (195,421,172 ) $ (178,988,098 )
Total Stockholders' Equity $ 23,646,260 $ 4,934,256
CORMEDIX INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
Years Ended December 31,
2019 2018
Cash Flows From Operating Activities:
Net loss $ (16,433,074 ) $ (26,829,630 )
Net cash used in operating activities (15,052,024 ) (23,700,565 )
Cash Flows Used In Investing Activities:
Net cash used in (provided by) investing activities (12,020,459 ) 1,555,414
Cash Flows From Financing Activities:
Net cash provided by financing activities 25,804,362 29,397,070
Foreign exchange effects on cash (2,015 ) (7,878 )
Net (Decrease) Increase in Cash and Cash Equivalents (1,270,136 ) 7,244,041
Cash and Cash Equivalents and Restricted Cash - Beginning of Period 17,795,323 10,551,282
Cash -and Cash Equivalents and Restricted Cash - End of Period $ 16,525,187 $ 17,795,323
Last updated: Mar 16, 2020