CorMedix Inc. Reports First Quarter 2023 Financial Results and Provides Business Update
15 Mai 2023 - 10:05PM
CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused
on developing and commercializing therapeutic products for the
prevention and treatment of life-threatening diseases and
conditions, today announced financial results for the first quarter
ended March 31, 2023 and provided an update on recent business
developments.
Recent Corporate Highlights:
- As previously
guided, CorMedix is resubmitting its DefenCath New Drug
Application, or NDA, to the U.S. Food and Drug Administration
(“FDA”). The Company anticipates that the NDA will be classified as
a Type 2 resubmission with a 6-month review cycle with a target
action date in November.
- The Company
also recently announced that the US Patent & Trademark office
has issued a notice of allowance of patent claims directed to the
composition of a catheter lock solution for preventing infection
and reduced blood flow in central venous catheters. This newly
allowed U.S. Patent Application reflects the unique and proprietary
nature of DefenCath, and will extend our current intellectual
property protection to an anticipated expiration date in 2042.
- CorMedix recently announced that
following our submission of a duplicate New Technology Add-On
Payment, or NTAP, application to the Centers for Medicare &
Medicaid Services, CMS has issued the Inpatient Prospective Payment
System 2024 proposed rule that includes an NTAP of up to $17,111
per hospital stay for DefenCath. This NTAP is conditioned upon the
DefenCath NDA obtaining final FDA approval prior to July 1,
2024.
- Cash and short-term investments,
excluding restricted cash, at March 31, 2023 amounted to $55.6
million.
Joe Todisco, CorMedix CEO, commented, “we are
excited to announce today that our DefenCath NDA is ready to be
resubmitted to FDA. The resubmission reflects the hard work of the
CorMedix regulatory and technical teams and our strategic partners,
and we will now increase our focus on preparations for a potential
commercial launch in early 2024. We look forward to providing
additional updates as we progress toward potential approval in 2023
and aim to deliver on our commitment to reducing the risk of
infections in patients receiving hemodialysis via central venous
catheters.”
First Quarter 2023 Financial Highlights
For the first quarter of 2023, CorMedix recorded
a net loss of $10.6 million, or $0.24 per share, compared with a
net loss of $7.0 million, or $0.18 per share, in the first quarter
of 2022, an increase of $3.5 million, driven primarily by an
increase in operating expenses.
Operating expenses in the first quarter 2023
were $11.0 million, compared with $7.0 million in the first quarter
of 2022, an increase of approximately 57%. The increase was
driven by higher SG&A expenses which increased approximately
60% to $7.6 million, primarily driven by costs related to market
research studies and pre-launch activities in preparation for the
potential approval of DefenCath, and an increase in personnel
expenses and non-cash charges for stock-based compensation. R&D
expenses also increased by 49% to $3.4 million, primarily due to
net increases in personnel expenses and non-cash charges for
stock-based compensation. Additionally, there were also increases
in medical affairs activities in preparation for the potential
marketing approval of DefenCath and costs related to the
manufacturing of DefenCath prior to its potential marketing
approval.
The Company reported cash and short-term
investments of $55.6 million at March 31, 2023, excluding
restricted cash. The Company believes that it has sufficient
resources to fund operations at least through the first half of
2024.
Conference Call Information
The management team of CorMedix will host a
conference call and webcast today, May 15, 2023, at 4:30PM Eastern
Time, to discuss recent corporate developments and financial
results. Call details and dial-in information are as follows:
|
|
Monday, May 15th @ 4:30pm
ET |
Domestic: |
1-877-423-9813 |
International: |
1-201-689-8573 |
Conference ID: |
13729290 |
Webcast: |
Webcast Link |
|
|
About CorMedix
CorMedix Inc. is a biopharmaceutical company
focused on developing and commercializing therapeutic products for
the prevention and treatment of life-threatening conditions and
diseases. The Company is focused on developing its lead product
DefenCath™, a novel, non-antibiotic antimicrobial 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 second Complete Response Letter from the FDA
last August related to deficiencies at both its primary contract
manufacturer and its supplier of heparin API. The Company conducted
a Type A meeting with FDA in April of 2023 and received guidance to
support resubmission of the NDA for DefenCath in mid-May of 2023.
CorMedix also intends to develop DefenCath as a catheter lock
solution for use in other patient populations, and the Company is
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, Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, 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, including, but not limited to, statements regarding the
ability of the Company’s DefenCath NDA resubmission to be
classified as Class 2 and the timing of review, CorMedix’s future
financial position, financing plans, future revenues, projected
costs and the sufficiency of our cash and short-term investments to
fund our operations 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 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; the ability
to secure final FDA approval prior to July 1, 2024; the risks and
uncertainties associated with CorMedix’s ability to manage its
limited cash resources and the impact on current, planned or future
research; 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. 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 Ended March
31, |
|
|
2023 |
|
2022 |
Revenue |
|
|
|
|
Net sales |
$ |
- |
|
$ |
7,636 |
|
Cost of sales |
|
- |
|
|
(1,527) |
|
Gross profit |
|
- |
|
|
6,109 |
|
Operating
Expenses |
|
|
|
|
Research and development |
|
(3,407,502) |
|
|
(2,287,587) |
|
Selling, general and administrative |
|
(7,609,677) |
|
|
(4,750,883) |
|
Total operating expenses |
|
(11,017,179) |
|
|
(7,038,470) |
|
Loss from
Operations |
|
(11,017,179) |
|
|
(7,032,361) |
|
Other Income
(Expense) |
|
|
|
|
Total other income (expense) |
|
(449,953) |
|
|
(1,833) |
|
Net Loss |
|
(10,567,226) |
|
|
(7,034,194) |
|
Other Comprehensive
Income (Loss) |
|
|
|
|
Total other comprehensive income (loss) |
|
18,489 |
|
|
(37,209) |
|
Other Comprehensive
Loss |
$ |
(10,548,737) |
|
$ |
(7,071,403) |
|
Net Loss Per Common Share
– Basic and Diluted |
$ |
(0.24) |
|
$ |
(0.18) |
|
Weighted Average Common
Shares Outstanding – Basic and Diluted |
|
44,090,998 |
|
|
38,247,059 |
|
|
|
|
|
|
|
|
CORMEDIX INC. AND SUBSIDIARIES |
CONDENSED CONSOLIDATED BALANCE SHEET DATA |
(Unaudited) |
|
|
|
March 31, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
|
|
|
ASSETS |
|
|
|
Cash, cash equivalents and restricted cash |
$ |
25,496,744 |
|
$ |
43,374,745 |
|
Short-term investments |
$ |
30,332,493 |
|
$ |
15,644,062 |
|
Total
Assets |
$ |
59,233,659 |
|
$ |
62,038,259 |
|
|
|
|
|
|
Total
Liabilities |
$ |
5,305,905 |
|
$ |
6,978,523 |
|
Accumulated deficit |
$ |
(285,928,012) |
|
$ |
(275,360,786) |
|
Total Stockholders’
Equity |
$ |
53,927,754 |
|
$ |
55,059,736 |
|
|
|
|
|
|
|
|
CORMEDIX INC. AND SUBSIDIARIES |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS |
(Unaudited) |
|
|
For the Three Months Ended March
31, |
|
2023 |
|
2022 |
|
|
|
|
Cash Flows from
Operating Activities: |
|
|
|
Net loss |
$ |
(10,567,226) |
|
|
$ |
(7,034,194) |
|
Net cash used in operating
activities |
|
(10,393,886) |
|
|
|
(6,744,342) |
|
Cash Flows Used in
Investing Activities: |
|
|
|
Net cash used in investing
activities |
|
(14,686,805) |
|
|
|
(4,187,661) |
|
Cash Flows from
Financing Activities: |
|
|
|
Net cash provided by financing
activities |
|
7,200,406 |
|
|
|
3,004,216 |
|
Net Decrease in Cash
and Cash Equivalents |
|
(17,878,001) |
|
|
|
(7,930,966) |
|
Cash and Cash Equivalents and Restricted Cash - Beginning
of Period |
|
43,374,745 |
|
|
|
53,551,277 |
|
Cash and Cash Equivalents and Restricted Cash - End of
Period |
$ |
25,496,744 |
|
|
$ |
45,620,311 |
|
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