CorMedix Inc. Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
March 30 2021 - 4:05PM
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 fourth quarter and full
year ended December 31, 2020 and provided an update on recent
business developments.
Recent Corporate
Highlights:
- CorMedix announced in early March
2021 that the US Food and Drug Administration (FDA) cannot approve
the New Drug Application (NDA) for DefenCath in its present
form. FDA noted concerns at the third-party manufacturing
facility after a review of records requested by FDA and provided by
the manufacturing facility, and has requested a manual extraction
study to demonstrate that the labeled volume can be consistently
withdrawn from vials.
- CorMedix continues to work closely
with our third-party manufacturing facility and is planning for a
meeting with the FDA in mid-April to obtain agreement on the
adequacy of our proposed plans for resolution of the
deficiencies.
- CorMedix transitioned to Nasdaq in
early February 2021, which has become the primary trading platform
for biopharmaceutical peers and other growth companies.
- CorMedix has strengthened its
balance sheet via equity financing activity over the past year and
early 2021.
- CorMedix has been approved by the
New Jersey Economic Development Authority (NJEDA) to transfer
substantially all of the $1.3 million of its available tax benefits
to an unrelated, profitable New Jersey corporation pursuant to the
New Jersey Technology Business Tax Certificate Transfer (NOL)
program for State Fiscal Year 2020, for approximately $1.3 million
in net proceeds. Closing is anticipated in 2Q of 2021.
Khoso Baluch, CorMedix CEO commented, “While we
were disappointed that the DefenCath NDA was not approved at its
PDUFA date, we remain confident in our efforts to bring DefenCath
to hemodialysis patients as an important novel antimicrobial
catheter lock solution to reduce catheter related blood stream
infections in patients receiving hemodialysis via central venous
catheters. We believe we have the right team and resources to
accomplish this as we advance DefenCath closer to regulatory
approval.”
4th Quarter 2020 Financial
Highlights
For the fourth quarter of 2020, CorMedix
recorded a net loss of $6.1 million, or $0.19 per share, compared
with a net loss of $5.3 million, or $0.21 per share, in the fourth
quarter of 2019, an increase in net loss of $0.8 million. The
increase in net loss in the fourth quarter of 2020 compared with
2019 was primarily driven by increases in employee costs and market
research costs. Operating expenses during the fourth quarter
of 2020 were $6.1 million, compared with $5.4 million in the fourth
quarter of 2019, an increase of approximately $0.7
million.
Full Year 2020 Financial
Highlights
For the year ended December 31, 2020, CorMedix
recorded a net loss of $22.0 million, or $0.77 per share, compared
with a net loss during the year ended December 31, 2019 of $16.4
million before recognition of deemed dividends, or $0.68 per share,
an increase in net loss of $5.6 million. The increase in net loss
was driven primarily by increases in operating expenses.
Operating expenses during the year ended
December 31, 2020 amounted to $27.3 million compared with $20.9
million during the comparable period in 2019, an increase of $6.4
million, or 30%, due to a 21% increase in R&D expense and 41%
increase in SG&A expense.
Total cash on hand and short-term investments as
of December 31, 2020 amounted to $46.3 million, excluding
restricted cash of $0.2 million. The Company believes that,
based on the Company’s cash resources at year end plus the $41.5
million in net proceeds from ATM issuances since the beginning of
2021, it has sufficient resources to fund operations at least into
the second half of 2022.
Conference Call Information
The management team of CorMedix will host a
conference call and webcast today, March 30, 2021, at 4:30 PM
Eastern Time, to discuss recent corporate developments and
financial results. Call details and dial-in information is as
follows:
Tuesday, March 30th @ 4:30pm
ET Domestic: 877-423-9813 International: 201-689-8573
Conference ID: 13715664 Webcast: Webcast Link
About CorMedix
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
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,
which provides 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 intends to develop
DefenCath as a catheter lock solution for use in oncology and total
parenteral nutrition patients. 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.
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 DefenCath development path for marketing
authorization; the resources needed to secure approval of the new
drug application for DefenCath from 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
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.
Investor Contact:Dan
FerryManaging DirectorLifeSci 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, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
| Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
$ |
55,713 |
|
|
$ |
24,779 |
|
|
$ |
239,231 |
|
|
$ |
283,266 |
|
|
Cost of sales |
|
(57,233 |
) |
|
|
(46,125 |
) |
|
|
(204,846 |
) |
|
|
(373,234 |
) |
|
Gross profit |
|
(1,520 |
) |
|
|
(21,346 |
) |
|
|
34,385 |
|
|
|
(89,968 |
) |
| Operating
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
(2,294,430 |
) |
|
|
(2,677,007 |
) |
|
|
(13,377,193 |
) |
|
|
(11,052,903 |
) |
|
Selling, general and administrative |
|
(3,788,690 |
) |
|
|
(2,677,470 |
) |
|
|
(13,877,944 |
) |
|
|
(9,865,005 |
) |
|
Total Operating Expenses |
|
(6,083,120 |
) |
|
|
(5,354,477 |
) |
|
|
(27,255,137 |
) |
|
|
(20,917,908 |
) |
| Income (loss) From
Operations |
|
(6,084,640 |
) |
|
|
(5,375,823 |
) |
|
|
(27,220,752 |
) |
|
|
(21,007,876 |
) |
| Other Income
(Expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
2,940 |
|
|
|
75,788 |
|
|
|
116,065 |
|
|
|
322,668 |
|
|
Foreign exchange transaction loss |
|
76 |
|
|
|
2,126 |
|
|
|
(59,165 |
) |
|
|
(21,156 |
) |
|
Change in fair value of derivative liability |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Interest and amortization expense |
|
(5,322 |
) |
|
|
(6,276 |
) |
|
|
(33,226 |
) |
|
|
(787,488 |
) |
|
Total Other Income (Expense) |
|
(2,306 |
) |
|
|
71,638 |
|
|
|
23,674 |
|
|
|
(485,976 |
) |
| Net Loss Before Income
Taxes |
|
(6,086,946 |
) |
|
|
(5,304,185 |
) |
|
|
(27,197,078 |
) |
|
|
(21,493,852 |
) |
|
Tax benefit |
|
- |
|
|
|
- |
|
|
|
5,169,395 |
|
|
|
5,060,778 |
|
| Net Loss |
|
(6,086,946 |
) |
|
|
(5,304,185 |
) |
|
|
(22,027,683 |
) |
|
|
(16,433,074 |
) |
|
Other Comprehensive Income (Loss) |
|
2,347 |
|
|
|
(4,745 |
) |
|
|
4,749 |
|
|
|
735 |
|
| Comprehensive Income
(Loss) |
$ |
(6,084,599 |
) |
|
$ |
(5,308,930 |
) |
|
$ |
(22,022,934 |
) |
|
$ |
(16,432,339 |
) |
| Net loss |
|
(6,086,946 |
) |
|
|
(5,304,185 |
) |
|
|
(22,027,683 |
) |
|
|
(16,433,074 |
) |
|
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 |
|
(6,086,946 |
) |
|
|
(5,304,185 |
) |
|
|
(22,027,683 |
) |
|
|
(43,535,672 |
) |
| Net Income (Loss) Per
Common Share – Basic and Diluted |
$ |
(0.19 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.77 |
) |
|
$ |
(1.80 |
) |
| Weighted Average Common
Shares Outstanding – Basic and Diluted |
|
32,402,336 |
|
|
|
25,665,619 |
|
|
|
28,561,963 |
|
|
|
24,152,088 |
|
CORMEDIX INC. AND
SUBSIDIARIESCONSOLIDATED BALANCE
SHEETS(Audited)
| |
|
December 31, |
|
|
|
December 31, |
|
|
|
|
2020 |
|
|
|
2019 |
|
| |
|
|
|
|
|
| ASSETS |
|
|
|
|
| Cash, cash equivalents and
restricted cash |
$ |
42,096,783 |
|
|
$ |
16,525,187 |
|
| Short-term investments |
$ |
4,444,072 |
|
|
$ |
11,984,157 |
|
| Total
Assets |
$ |
49,308,303 |
|
|
$ |
29,475,910 |
|
| |
|
|
|
|
|
| Total
Liabilities |
$ |
5,085,291 |
|
|
$ |
5,829,650 |
|
| Accumulated deficit |
$ |
(217,448,855 |
) |
|
$ |
(195,421,172 |
) |
| Total Stockholders’
Equity |
$ |
44,223,012 |
|
|
$ |
23,646,260 |
|
CORMEDIX INC. AND
SUBSIDIARIESCONSOLIDATED STATEMENTS OF CASH
FLOWS(Audited)
| |
|
Years Ended December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
| |
|
|
|
| Cash Flows From
Operating Activities: |
|
|
|
| Net loss |
$ |
(22,027,683 |
) |
|
$ |
(16,433,074 |
) |
| Net cash used in operating
activities |
|
(21,967,638 |
) |
|
|
(15,052,024 |
) |
| Cash Flows Used In
Investing Activities: |
|
|
|
| Net cash used in (provided by)
investing activities |
|
7,426,176 |
|
|
|
(12,020,459 |
) |
| Cash Flows From
Financing Activities: |
|
|
|
| Net cash provided by financing
activities |
|
40,099,866 |
|
|
|
25,804,362 |
|
| Foreign exchange effects on
cash |
|
13,192 |
|
|
|
(2,015 |
) |
| Net Increase
(Decrease) in Cash and Cash Equivalents |
|
25,571,596 |
|
|
|
(1,270,136 |
) |
| Cash and Cash
Equivalents and Restricted Cash - Beginning of Period |
|
16,525,187 |
|
|
|
17,795,323 |
|
| Cash -and Cash
Equivalents and Restricted Cash - End of Period |
$ |
42,096,783 |
|
|
$ |
16,525,187 |
|
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