CorMedix Inc. Reports First Quarter 2019 Financial Results and Provides Business Update
May 13 2019 - 4:05PM
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 first quarter
ended March 31, 2019 and provided an update on recent business
events.
Recent Corporate and Clinical Highlights:
- Announced that the Company has
completed the statistical analyses of data and additional
information requested by FDA for the primary and secondary efficacy
endpoints of the Company’s LOCK-IT-100 clinical study. These
analyses support the strong topline results previously
announced.
- FDA has granted the Company’s
meeting request to continue its dialogue on the data from
LOCK-IT-100 and its support as substantial evidence of safety
and effectiveness of Neutrolin® as a catheter-lock solution in
hemodialysis patients for the New Drug Application.
- Presented results of the Company’s
Phase 3 LOCK-IT-100 Study at the National Kidney Foundation Spring
2019 Clinical Meetings. A total of 41 catheter-related blood stream
infections (CRBSIs) was determined by the Clinical Adjudication
Committee (CAC) in the full data set, compared with 28 CRBSI cases
in the interim analysis. The full data set showed a 71% reduction
in the risk of occurrence of CRBSIs compared with the active
control of heparin, which is well in excess of the study’s assumed
treatment effect size of a 55% reduction and statistically
significant with a p-value of 0.0006.
- Appointed Dr. Phoebe Mounts, Esq.
as Executive Vice President and General Counsel, leading the
Company’s legal, compliance and regulatory affairs. Dr. Mounts has
been a trusted legal advisor to the Company since 2013 and has been
responsible for developing the FDA regulatory strategies for
Neutrolin.
- Completed the previously announced
sale of $5.4 million of NOL tax benefits to two unrelated,
profitable New Jersey corporations through the New Jersey Economic
Development Authority’s New Jersey Technology Business Tax
Certificate Transfer program for State Fiscal Year 2018. As a
result, the Company has received approximately $5.1 million in cash
from the sale of these NOL tax benefits.
- Announced that the Company had
regained compliance with the NYSE American listing
requirements.
- Cash, cash equivalents and
short-term investments at March 31, 2019 amounted to $26.4
million.
Khoso Baluch, CorMedix CEO, commented, “We are
pleased that our current discussions with the FDA are continuing
and we look forward to completing the clinical study report, which
is required to demonstrate the safety and efficacy of
Neutrolin as a catheter-lock solution for hemodialysis patients.
The team continues in parallel to prepare the additional components
required for an NDA filing. In our view, the results of the
LOCK-IT-100 study strongly support our case for Neutrolin’s
efficacy and safety as a catheter lock solution in hemodialysis
patients.”
Mr. Baluch continued, “We are also pleased with
our financial results this quarter and with the receipt of $5.1
million in funding through the NJ NOL program. As a result, our
liquidity at March 31 is the highest in several years. We believe
the funds we have available are sufficient for us to complete
the regulatory discussion with the FDA and file an NDA if the FDA
agrees with our request to file based on a single study.”
First Quarter 2019 Financial Highlights
For the first quarter 2019, CorMedix recorded a
net loss of $5.2 million, or $0.22 per share, compared with a net
loss of $10.2 million, or $0.68 per share, in the first quarter of
2018, a decrease of $5.0 million. Net loss in the first quarter of
2019 was driven by decreased costs related to the LOCK-IT-100
clinical study due to the winding down of the study while other
expenses continued to decline or remained flat.
Operating expenses in the first quarter 2019
were $4.9 million, compared to $10.2 million in the fourth quarter
of 2018, a decrease of approximately 52%. R&D expense
decreased approximately 65% to $2.9 million, due to a 77% decrease
in clinical trial expense. SG&A expense increased by
4%.
Conference Call Information:
The management team of CorMedix will host a
conference call and webcast today, May 13, 2019, at 4:30 PM Eastern
Time, to discuss recent corporate developments and financial
results. Call details and dial-in information are as follows:
| Domestic: |
877-407-9124 |
| International: |
201-689-8584 |
| Passcode: |
13690433 |
| Webcast (with slides): |
|
| |
https://www.investornetwork.com/event/presentation/48100 |
|
| Replay will be
available through May 28, 2019: |
| Domestic: |
877-481-4010 |
| International: |
919-882-2331 |
| Conference ID: |
48100 |
The management team will share the slide presentation that was
made on May 10, 2019 at the National Kidney Foundation (NKF) Spring
2019 Clinical Meetings during the webcast. Please log into
the investor section of the Company’s website for a link to the
slide presentation.
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
Neutrolin®, a novel, non-antibiotic antimicrobial solution designed
to prevent costly and dangerous bloodstream infections associated
with the use of central venous catheters, currently in Phase 3
development for patients undergoing chronic hemodialysis. Such
infections have significant treatment costs and lead to increased
morbidity and mortality. Neutrolin has FDA Fast Track status and is
designated as a Qualified Infectious Disease Product, which provide
the potential for priority review of a marketing application
by FDA and allow for a total of ten years of 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; 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; risks relating to the effect of the reverse stock split
on the Company’s stock price and its overall market capitalization;
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
Advisors617-535-7746
|
CORMEDIX INC. AND SUBSIDIARYCONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
|
|
For the Three Months EndedMarch
31, |
|
|
|
2019 |
|
|
2018 |
|
| Revenue |
|
|
|
|
| Net sales |
$ |
163,692 |
|
$ |
23,210 |
|
| Cost of sales |
|
(226,955 |
) |
|
(28,575 |
) |
|
Gross loss |
|
(63,263 |
) |
|
(5,365 |
) |
| Operating
Expenses |
|
|
|
|
|
Research and development |
|
(2,874,996 |
) |
|
(8,280,442 |
) |
|
Selling, general and administrative |
|
(1,984,922 |
) |
|
(1,903,016 |
) |
|
Total operating expenses |
|
(4,859,918 |
) |
|
(10,183,458 |
) |
| Loss from
Operations |
|
(4,923,181 |
) |
|
(10,188,823 |
) |
| Other Income
(Expense) |
|
|
|
|
|
Interest income |
|
58,822 |
|
|
14,775 |
|
|
Foreign exchange transaction loss |
|
(1,477 |
) |
|
(9,197 |
) |
|
Interest expense |
|
(302,048 |
) |
|
(1,873 |
) |
|
Total other income (expense) |
|
(244,703 |
) |
|
3,705 |
|
| Net Loss |
|
(5,167,884 |
) |
|
(10,185,118 |
) |
| Other Comprehensive
Income (Loss) |
|
|
|
|
|
Unrealized gain from investment |
|
(1,008 |
) |
|
- |
|
|
Foreign currency translation loss |
|
(305 |
) |
|
(1,425 |
) |
|
Total comprehensive income (loss) |
|
(1,313 |
) |
|
(1,425 |
) |
| Comprehensive
Loss |
$ |
(5,169,197 |
) |
$ |
(10,186,543 |
) |
| Net Loss Per Common Share
– Basic and Diluted |
$ |
(0.22 |
) |
$ |
(0.68 |
) |
| Weighted Average Common
Shares Outstanding – Basic and Diluted |
|
23,074,049 |
|
|
15,071,282 |
|
|
CORMEDIX INC. AND SUBSIDIARYCONDENSED CONSOLIDATED
BALANCE SHEET DATA |
| |
|
March 31, |
|
|
|
|
2019 |
|
|
2018 |
|
|
| |
|
|
|
|
|
| Assets |
|
|
|
|
| |
|
|
|
|
| Cash and cash equivalents |
$ |
18,256,999 |
|
$ |
17,623,770 |
|
|
| Short-term investments |
$ |
7,944,549 |
|
$ |
- |
|
|
| Total Assets |
$ |
27,308,220 |
|
$ |
18,825,914 |
|
|
| Total
Liabilities |
$ |
10,766,255 |
|
$ |
13,891,658 |
|
|
| Accumulated deficit |
$ |
(184,155,982 |
) |
$ |
(178,988,098 |
) |
|
| Total Stockholders’
Equity |
$ |
16,541,965 |
|
$ |
4,934,256 |
|
|
|
CORMEDIX INC. AND SUBSIDIARYCONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS |
|
|
For the Three Months EndedMarch
31, |
|
|
|
2019 |
|
|
|
2018 |
|
| |
|
|
|
| Cash Flows from
Operating Activities: |
|
|
|
| Net loss |
$ |
(5,167,884 |
) |
|
$ |
(10,185,118 |
) |
| Net cash used in operating
activities |
|
(7,367,470 |
) |
|
|
(7,054,303 |
) |
| Cash Flows Used in
Investing Activities: |
|
|
|
| Net cash (used in) provided by
investing activities |
|
(7,964,777 |
) |
|
|
1,565,972 |
|
| Cash Flows from
Financing Activities: |
|
|
|
| Net cash provided by financing
activities |
|
15,967,575 |
|
|
|
3,269,163 |
|
| Net Increase
(Decrease) in Cash |
|
633,229 |
|
|
|
(2,217,695 |
) |
| Cash - Beginning of
Period |
|
17,795,323 |
|
|
|
10,551,282 |
|
| Cash - End of
Period |
$ |
18,428,552 |
|
|
$ |
8,333,587 |
|
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