CorMedix Inc. Reports Third Quarter and Nine Month 2023 Financial Results and Provides Business Update
November 14 2023 - 4:05PM
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 third quarter
and nine months ended September 30, 2023 and provided an update on
recent business events.
Recent Corporate Highlights:
- The FDA completed a preapproval
inspection for CorMedix’s primary finished dosage CMO site in
September and the Company is pleased with the outcome. In addition,
the FDA has also conducted preapproval inspections for DefenCath at
suppliers of active pharmaceutical ingredients, contract
laboratories involved in testing of product specifications and
packaging facilities, and CorMedix is not aware of any outstanding
deficiencies or review issues at this time.
- CorMedix has intensified
preparations for commercial launch with a number of new hires in
market access, sales training, pricing and contracting, commercial
operations, field medical, and drug safety and
pharmacovigilance.
- In the event CorMedix receives
final FDA approval over the coming days, the Company is targeting a
commercial launch before the end of the first quarter of 2024.
- The United States Patent and
Trademark Office (USPTO) issued a patent with claims directed to
the composition of a catheter lock solution for preventing
infection and reduced blood flow in central venous catheters. This
Patent reflects the unique and proprietary nature of DefenCath®,
and will extend the Company’s intellectual property protection with
an expiration date of April 15, 2042.
- Cash and short-term investments,
excluding restricted cash, at September 30, 2023 amounted to $86.6
million.
Joe Todisco, CorMedix CEO, commented, “I am very
pleased with the Company’s progress on all fronts, most notably the
outcomes of the preapproval inspections at our primary CMO facility
and other key vendors, as well as our preparations toward
commercial readiness. We have accelerated multiple work streams
aimed at commercial launch, and made a number of key hires over the
past quarter that are essential to ensuring a successful commercial
launch following a potential FDA approval of DefenCath. We look
forward to providing additional updates over the coming days as we
anticipate a response from FDA on or around our target action
date.”
Third Quarter and Nine Month 2023 Financial
Highlights
For the third quarter of 2023, CorMedix recorded
a net loss of $9.7 million, or $0.17 per share, compared with a net
loss of $6.9 million, or $0.17 per share, in the third quarter of
2022. The higher net loss recognized during the third quarter of
2023 compared with 2022 was attributable to net increase in
operating expenses primarily due to increased pre-launch commercial
activities for DefenCath.
Operating expenses in the third quarter of 2023
increased approximately 50% to $10.5 million, compared with $7.0
million in the third quarter of 2022. R&D expense increased
approximately 14% to $2.7 million compared to $2.3 million in the
third quarter of 2022, mainly due to a net increase in costs
related to medical affairs activities and increase in personnel
related expenses due to additional hires in 2023 as compared with
2022. SG&A expense increased approximately 69% to $7.8 million
compared with $4.6 million in the third quarter of 2022. This
increase was driven primarily by an increase in costs related to
market research studies and pre-launch activities in preparation
for the potential marketing approval of DefenCath and as a result
of additional hires in 2023 as compared with 2022.
For the nine months ended September 30, 2023,
CorMedix recorded a net loss of $31.6 million, or $0.65 per share,
compared with a net loss of $21.5 million, or $0.54 per share, in
the first nine months of 2022. The increase in net loss in the
first nine months of 2023 was driven primarily by an increase in
operating expenses.
Operating expenses in the first nine months of
2023 were $33.3 million compared with $22.3 million during the
comparable period in 2022, an increase of approximately 49%. This
increase was primarily attributable to costs related to market
research studies and pre-launch activities in preparation for the
potential marketing approval of DefenCath, and an increase in
personnel expenses due to additional hires in 2023.
Total cash on hand and short-term investments as
of September 30, 2023 was $86.6 million, excluding restricted cash
of $0.2 million. The Company believes that, based on the Company’s
cash resources at September 30, 2023, it has sufficient resources
to fund operations at least twelve months from the filing of its
Quarterly Report on Form 10-Q for the quarter ended September 30,
2023.
Conference Call Information
The management team of CorMedix will host a
conference call and webcast today, November 14, 2023, at 4:30 PM
Eastern Time, to discuss recent corporate developments and
financial results. Call details and dial-in information is as
follows:
| Domestic: |
1-888-886-7786 |
| International: |
1-416-764-8658 |
| Conference ID: |
16013968 |
| 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 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. CorMedix 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. After receiving guidance from FDA at a
Type A meeting in April of 2023, the NDA for DefenCath was
resubmitted. In June of 2023, the resubmitted NDA was accepted for
filing by the FDA with a PDUFA target action date of November 15,
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 StatementsThis 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, the potential FDA approval of DefenCath, the timing of a
commercial launch of DefenCath, if approved, 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
statements. Readers are cautioned that actual results may differ
materially from projections or estimates due to a variety of
important factors, including: the risks and uncertainties related
to market conditions; the ability to secure final FDA approval for
DefenCath and the timing of such approval; the result of FDA
preapproval inspections for DefenCath suppliers; CorMedix’s ability
to manage its cash resources and the impact on current, planned or
future research; the effectiveness of CorMedix’s commercial
preparedness activities ahead of the target action date; and that
preclinical results are not indicative of success in clinical
trials and might not be replicated in any subsequent studies or
trials. 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 SUBSIDIARIESCONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(Unaudited) |
|
|
| |
|
For the Three Months EndedSeptember 30, |
|
For the Nine Months EndedSeptember
30, |
|
|
|
2023 |
|
|
2022 |
|
|
2022 |
|
|
2022 |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
Net sales |
$ |
- |
|
$ |
6,817 |
|
$ |
- |
|
$ |
35,706 |
|
|
Cost of sales |
|
- |
|
|
(1,469 |
) |
|
- |
|
|
(3,328 |
) |
|
Gross profit |
|
- |
|
|
5,348 |
|
|
- |
|
|
32,378 |
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
(2,663,976 |
|
|
(2,339,268 |
) |
|
(10,866,236 |
) |
|
(7,836,327 |
) |
|
Selling, general and administrative |
|
(7,803,307 |
|
|
(4,628,014 |
) |
|
(22,422,808 |
) |
|
(14,430,791 |
) |
|
Total Operating Expenses |
|
(10,467,283 |
) |
|
(6,967,282 |
) |
|
(33,289,044 |
) |
|
(22,267,118 |
) |
|
Loss From Operations |
|
(10,467,283 |
) |
|
(6,961,934 |
) |
|
(33,289,044 |
) |
|
(22,234,740 |
) |
|
Other Income (Expense): |
|
|
|
|
|
|
|
|
|
Total Other Income |
|
722,929 |
|
|
108,213 |
|
|
1,703,846 |
|
|
156,369 |
|
|
Loss before income taxes |
|
(9,744,354 |
) |
|
(6,853,721 |
) |
|
(31,585,198 |
) |
|
(22,078,371 |
) |
|
Tax benefit |
|
- |
|
|
- |
|
|
- |
|
|
585,617 |
|
|
Net Loss |
|
(9,744,354 |
) |
|
(6,853,721 |
) |
|
(31,585,198 |
) |
|
(21,492,754 |
) |
|
Other Comprehensive Income (Loss): |
|
|
|
|
|
|
|
|
|
Total Other Comprehensive (Loss) Income |
|
(6,298 |
) |
|
6,253 |
|
|
1,656 |
|
|
(41,358 |
) |
|
Comprehensive Loss |
$ |
(9,750,652 |
) |
$ |
(6,847,468 |
) |
$ |
(31,583,542 |
) |
$ |
(21,534,112 |
) |
|
Net Loss Per Common Share – Basic and Diluted |
$ |
(0.17 |
) |
$ |
(0.17 |
) |
$ |
(0.65 |
) |
$ |
(0.54 |
) |
|
Weighted Average Common Shares Outstanding – Basic and
Diluted |
|
56,553,174 |
|
|
41,183,585 |
|
|
48,715,585 |
|
|
39,741,555 |
|
|
|
|
CORMEDIX INC. AND SUBSIDIARIESCONDENSED
CONSOLIDATED BALANCE SHEET
DATA(Unaudited) |
|
|
| |
|
September 30, |
|
December 31, |
|
|
|
2022 |
|
|
2022 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
| Cash, cash equivalents and
restricted cash |
$ |
53,501,021 |
|
$ |
43,374,745 |
|
| Short-term investments |
$ |
33,273,259 |
|
$ |
15,644,062 |
|
| Total
Assets |
$ |
91,429,120 |
|
$ |
62,038,259 |
|
|
|
|
|
|
|
| Total
Liabilities |
$ |
8,227,298 |
|
$ |
6,978,523 |
|
| Accumulated deficit |
$ |
(306,945,984 |
) |
$ |
(275,360,786 |
) |
| Total Stockholders’
Equity |
$ |
83,201,822 |
|
$ |
55,059,736 |
|
|
|
|
CORMEDIX INC. AND SUBSIDIARIESCONDENSED
CONSOLIDATED STATEMENTS OF CASH
FLOWS(Unaudited) |
|
|
| |
Nine Month Periods EndedSeptember 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
| Cash Flows from
Operating Activities: |
|
|
|
| Net loss |
$ |
(31,585,198 |
) |
|
$ |
(21,492,754 |
) |
| Net cash used in operating
activities |
|
(27,663,786 |
) |
|
|
(18,201,893 |
) |
| Cash Flows from
Investing Activities: |
|
|
|
| Net cash used in investing
activities |
|
(17,659,477 |
) |
|
|
(3,707,503 |
) |
|
|
|
|
|
| Cash Flows from
Financing Activities: |
|
|
|
| Net cash provided by financing
activities |
|
55,449,154 |
|
|
|
11,852,662 |
|
| Net Increase
(Decrease) in Cash and Cash Equivalents |
|
10,126,276 |
|
|
|
(10,081,198 |
) |
| 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 |
$ |
53,501,021 |
|
|
$ |
43,470,079 |
|
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