CorMedix Inc. Reports Second Quarter and Six Month 2021 Financial Results and Provides Business Update
August 12 2021 - 4:01PM
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, 2021 and provided an update on recent
developments.
Recent Business Highlights:
- CorMedix
remains focused in its efforts to resolve the deficiencies sent to
the third-party manufacturer in the Post-Application Action Letter
and remains on schedule to re-submit the DefenCath™ New Drug
Application in the fourth quarter of 2021.
- CorMedix
received approximately $1.3 million in net proceeds upon the
closing of the sale of tax benefits pursuant to the New Jersey
Technology Business Tax Certificate Transfer (NOL) program.
- CorMedix
has approximately $78.3 million in cash on hand and short-term
investments as of June 30; we believe this is sufficient to fund
operations at least through 2022.
Khoso Baluch, CorMedix CEO commented, “We are
pleased with the progress we are making as we address the
deficiencies identified by FDA at the third-party manufacturing
facility. 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.”
Second Quarter and Six Month 2021 Financial
Highlights
For the second quarter 2021, CorMedix recorded a
net loss of $4.6 million, or $0.12 per share, compared with a net
loss of $3.8 million, or $0.14 per share, in the second quarter of
2020. The higher net loss recognized in 2021 compared with 2020 was
due to increased personnel expenses and a lower tax benefit from
the NJ NOL program, partially offset by raw materials purchased
during 2Q of 2020. We recorded an increase in SG&A and a
decrease in R&D expenses. We recognized a tax benefit of $1.3
million in 2021 from the sale of our NJ Net Operating Losses
compared with a $5.2 million benefit recorded in 2020.
Operating expenses in the second quarter of 2021
decreased approximately 34% to $5.9 million, compared with $8.9
million in the second quarter of 2020. R&D expense decreased
approximately 56% to $2.5 million, mainly due to a $3.4 million
purchase of raw material during the second quarter of 2020 for the
manufacturing of DefenCath prior to its potential marketing
approval. SG&A expense increased approximately 4% to $3.4
million compared with $3.2 million in the second quarter of 2020.
This increase was driven primarily by an increase in non-cash
charges for stock-based compensation, and an increase in personnel
expenses as a result of additional hires, partially offset by a
decrease in consulting fees.
For the six months ended June 30, 2021, CorMedix
recorded a net loss of $11.8 million, or $0.32 per share, compared
with a net loss of $9.3 million, or $0.36 per share, in the first
half of 2020. Operating expenses in the first half of 2021 were
$13.1 million, compared to $14.6 million in the first half of 2020,
a decrease of approximately 10%. This decrease was primarily
due to the raw material purchased in 2nd quarter of 2020 partially
offset by higher SG&A expenses throughout the organization.
Total cash on hand and short-term investments as
of June 30, 2021 was $78.3 million, excluding restricted cash of
$0.2 million. The Company believes that, based on the Company’s
cash resources at June 30, 2021, it has sufficient resources to
fund operations at least through 2022, after taking into
consideration the costs for re-submission of the NDA and initial
preparations for the commercial launch for DefenCath.
Conference Call Information
The management team of CorMedix will host a
conference call and webcast today, August 12, 2021, at 4:30 PM
Eastern Time, to discuss recent corporate developments and
financial results. Call details and dial-in information is as
follows:
Domestic:International:Conference ID:Webcast: |
|
877-423-9813 201-698-857313721575Webcast 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
(QIDP), and the 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 from FDA stating that the NDA
could not be approved until satisfactory resolution of deficiencies
at the contract manufacturing facility, including in-process
controls for the filling operation. 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
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited)
|
|
For the Three Months EndedJune 30, |
|
For the Six Months Ended June
30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenue: |
|
|
|
|
|
|
|
|
Net sales |
$ |
8,191 |
|
$ |
16,443 |
|
$ |
96,451 |
|
$ |
90,498 |
|
Cost of sales |
|
(14,426 |
) |
|
(19,184 |
) |
|
(75,765 |
) |
|
(67,701 |
) |
Gross profit (loss) |
|
(6,235 |
) |
|
(2,741 |
) |
|
20,686 |
|
|
22,797 |
|
Operating
Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
(2,520,203 |
) |
|
(5,685,292 |
) |
|
(5,156,535 |
) |
|
(8,157,408 |
) |
Selling, general and administrative |
|
(3,355,790 |
) |
|
(3,232,576 |
) |
|
(7,956,896 |
) |
|
(6,397,747 |
) |
Total Operating Expenses |
|
(5,875,993 |
) |
|
(8,917,868 |
) |
|
(13,113,431 |
) |
|
(14,555,155 |
) |
Loss From
Operations |
|
(5,882,228 |
) |
|
(8,920,609 |
) |
|
(13,092,745 |
) |
|
(14,532,358 |
) |
Other Income
(Expense): |
|
|
|
|
|
|
|
|
Interest income |
|
3,340 |
|
|
38,603 |
|
|
7,014 |
|
|
102,282 |
|
Foreign exchange transaction gain (loss) |
|
(4,233 |
) |
|
(55,985 |
) |
|
(9,144 |
) |
|
(59,206 |
) |
Interest expense, including amortization of debt discount |
|
- |
|
|
(13,828 |
) |
|
(5,184 |
) |
|
(20,104 |
) |
Total Other Income (Expense) |
|
(893 |
) |
|
(31,210 |
) |
|
(7,314 |
) |
|
22,972 |
|
Loss before income taxes |
|
(5,883,121 |
) |
|
(8,951,819 |
) |
|
(13,100,059 |
) |
|
(14,509,386 |
) |
Tax benefit |
|
1,250,186 |
|
|
5,169,395 |
|
|
1,250,186 |
|
|
5,169,395 |
|
Net Loss |
|
(4,632,935 |
) |
|
(3,782,424 |
) |
|
(11,849,873 |
) |
|
(9,339,991 |
) |
Other Comprehensive
Income (Loss): |
|
|
|
|
|
|
|
|
Unrealized gain from investments |
|
(662 |
) |
|
13,853 |
|
|
(315 |
) |
|
8,221 |
|
Foreign currency translation gain (loss) |
|
1,017 |
|
|
1,001 |
|
|
(2,510 |
) |
|
112 |
|
Total Other Comprehensive Income (Loss) |
|
355 |
|
|
14,854 |
|
|
(2,825 |
) |
|
8,333 |
|
Comprehensive
Loss |
$ |
(4,632,580 |
) |
$ |
(3,767,570 |
) |
$ |
(11,852,698 |
) |
$ |
(9,331,658 |
) |
Net Loss Per Common
Share – Basic and Diluted |
$ |
(0.12 |
) |
$ |
(0.14 |
) |
$ |
(0.32 |
) |
$ |
(0.36 |
) |
Weighted Average
Common Shares Outstanding – Basic and Diluted |
|
38,083,842 |
|
|
26,143,360 |
|
|
37,211,233 |
|
|
26,101,493 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORMEDIX INC. AND
SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEET
DATA(Unaudited)
|
|
June 30, |
|
December 31, |
|
|
2021 |
|
2020 |
|
|
|
|
|
ASSETS |
|
|
|
Cash and cash equivalents and restricted cash |
$ |
73,333,215 |
|
$ |
42,096,783 |
|
Short-term investments |
$ |
5,159,353 |
|
$ |
4,444,072 |
|
Total
Assets |
$ |
80,857,111 |
|
$ |
49,308,303 |
|
|
|
|
|
|
Total
Liabilities |
$ |
3,987,566 |
|
$ |
5,085,291 |
|
Accumulated deficit |
$ |
(229,298,728 |
) |
$ |
(217,448,855 |
) |
Total Stockholders’
Equity |
$ |
76,869,545 |
|
$ |
44,223,012 |
|
Total Liabilities and
Stockholders’ Equity |
$ |
80,857,111 |
|
$ |
49,308,303 |
|
|
|
|
|
|
|
|
CORMEDIX INC. AND
SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOW DATA(Unaudited)
|
Six Month Periods Ended June 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
Cash Flows from
Operating Activities: |
|
|
|
Net loss |
$ |
(11,849,873 |
) |
|
$ |
(9,339,991 |
) |
Net cash used in operating
activities |
|
(9,782,326 |
) |
|
|
(8,721,295 |
) |
Cash Flows from
Investing Activities: |
|
|
|
Net cash (used in) provided by
investing activities |
|
(734,293 |
) |
|
|
6,030,389 |
|
|
|
|
|
Cash Flows from
Financing Activities: |
|
|
|
Net cash provided by financing
activities |
|
41,757,551 |
|
|
|
2,834,664 |
|
Net Increase in Cash
and Cash Equivalents |
|
31,236,432 |
|
|
|
143,940 |
|
Cash and Cash
Equivalents and Restricted Cash - Beginning of Period |
|
42,096,783 |
|
|
|
16,525,187 |
|
Cash and Cash
Equivalents and Restricted Cash - End of Period |
$ |
73,333,215 |
|
|
$ |
16,669,127 |
|
|
|
|
|
|
|
|
|
CorMedix (NASDAQ:CRMD)
Historical Stock Chart
From Mar 2024 to Apr 2024
CorMedix (NASDAQ:CRMD)
Historical Stock Chart
From Apr 2023 to Apr 2024