CORMEDIX INC. REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
March 16 2020 - 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 fourth quarter
and full year ended December 31, 2019 and provided an update on
recent business developments.
Recent Corporate Highlights:
- The Company has begun the submission process of the New Drug
Application (NDA) for Neutrolin® for the prevention of
catheter-related blood stream infections (CRBSIs) in hemodialysis
patients. The US Food and Drug Administration granted the
Company’s request for a rolling review, which is designed to
expedite the review process for products being developed to address
an unmet medical need.
- CorMedix has been granted a deferral under the Pediatric
Research Equity Act (PREA) that requires sponsors to conduct
pediatric studies for NDAs for a new active ingredient, such as
taurolidine in Neutrolin, unless a waiver or deferral is obtained
from FDA. A deferral acknowledges that a pediatric assessment
is required, but permits the applicant to submit the pediatric
assessment after the submission of an NDA. CorMedix has made
a commitment to conduct the pediatric study after approval of the
NDA for use in adult hemodialysis patients, and has submitted a
plan for the proposed pediatric study to FDA for review and
approval. Pediatric studies for an approved product conducted
under PREA may qualify for pediatric exclusivity, which would
provide an additional six months of market exclusivity.
Neutrolin would then have the potential to receive a total
marketing exclusivity period of 10.5 years.
- The Company believes it is on schedule for potential approval
of the NDA during the second half of 2020. However, because
the FDA has announced that it is postponing most foreign
inspections through April and inspections outside of the US deemed
mission-critical will still be considered on a case-by-case basis,
we cannot predict if this will delay approval of the NDA.
Pre-approval inspections of the manufacturing facilities
relied upon for manufacturing of Neutrolin are required. The
Company will provide updates on any delays that would prevent
approval of the NDA in the second half of 2020 as it becomes aware
of them.
- CorMedix has begun building internal functions for medical
affairs and payer markets, and hiring individuals to fill senior
roles in these new units. This gradual build up is expected to help
the Company move forward in preparing and refining its launch plans
as it moves closer to a potential Neutrolin approval. CorMedix
intends to continue building out those functions over the course of
2020, ending with the hiring of the field sales force and support
staff.
- CorMedix has been approved by the New Jersey Economic
Development Authority (NJEDA) to transfer approximately $5.5
million of the total $6.0 million of its available tax benefits to
an unrelated, profitable New Jersey corporation pursuant to the
Company’s application to participate in the New Jersey Technology
Business Tax Certificate Transfer (NOL) program for State Fiscal
Year 2019, for approximately $5.2 million in net proceeds.
Closing will occur as soon as possible.
Khoso Baluch, CorMedix CEO commented, “We are
very pleased to have received FDA agreement to submit our NDA on a
rolling basis, and to have commenced the submission process as a
result. We plan to continue our filing schedule and to be on track
for a decision in the second half of 2020, although we cannot at
this time anticipate the impact on our timetable of the FDA’s
postponement of most foreign inspections. We will continue
the NDA submission process along our planned timeline and will
provide material updates as they become available.”
4th Quarter 2019 Financial Highlights
For the fourth quarter of 2019, CorMedix
recorded a net loss attributable to common shareholders of $5.3
million, or $0.21 per share, compared with a net income of $2.2
million, or $0.10 per share, in the fourth quarter of 2018, an
increase in net loss of $7.5 million. The increase in net loss in
the fourth quarter 2019 compared with the gain in the fourth
quarter of 2018 was driven primarily by the reversal of clinical
trial expenses as a result of the settlement agreement with our CRO
in 2018. Operating expenses during the fourth quarter of 2019
were $5.4 million, compared with a gain of $2.1 million in the
fourth quarter of 2018, an increase of approximately $7.5
million.
Full Year 2019 Financial
Highlights
For the year ended December 31, 2019, CorMedix
recorded a net loss attributable to common shareholders of $43.5
million, or $1.80 per share, compared with a net loss of $26.8
million, or $1.51 per share, an increase of $16.7 million. The
increase in net loss was driven primarily by the deemed dividends
recognized as a result of the exchange agreement and modification
of certain warrants totaling $27.1 million for the year ended
December 31, 2019, partially offset by decreased clinical trial
expense of $9.7 million. The net loss before recognition of
the deemed dividends during the year ended December 31, 2019 was
$16.4 million.
Operating expenses during the year ended
December 31, 2019 amounted to $20.9 million compared with $26.9
million during the comparable period in 2018, a reduction of $6.0
million, or 22%, due to a 41% reduction in R&D expense
partially offset by a 22% increase in SG&A.
Total cash on hand and short-term investments as
of December 31, 2019 amounted to $28.3 million, excluding
restricted cash of $0.2 million. The Company believes that,
based on the Company’s cash resources at year end plus the $2.5
million of ATM proceeds received since the beginning of 2020 and
the $0.4 million net proceeds from the exercise of warrants, it has
sufficient resources to fund operations into the second quarter of
2021, including the submission of the NDA for Neutrolin and initial
preparations for commercial launch.
Conference Call Information
The management team of CorMedix will host a
conference call and webcast today, March 16, 2020, at 4:30 PM
Eastern Time, to discuss recent corporate developments and
financial results. Call details and dial-in information is as
follows:
Domestic: |
877-423-9813 |
International: |
201-689-8573 |
Passcode: |
13698818 |
Webcast: |
http://public.viavid.com/index.php?id=137974 |
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. The Company recently
completed a Phase 3 clinical trial of Neutrolin in patients
undergoing chronic hemodialysis, which showed a 71% reduction in
catheter-related bloodstream infections (CRBSIs) relative to the
heparin control arm (p=0.0006) with a good safety profile. Such
infections cost the U.S. healthcare system approximately $6 billion
annually and contribute significantly to increased morbidity and
mortality. Neutrolin has FDA Fast Track status and is designated as
a Qualified Infectious Disease Product, which provides the
potential for priority review of a marketing application by FDA and
allows for 5 additional years of QIDP 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, including whether a
second Phase 3 clinical trial for Neutrolin will be required; 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; 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. At this time, we are unable to assess whether, and
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 Advisors617-535-7746
CORMEDIX INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS)
|
|
For the Three Months Ended December 31, |
|
For the Years Ended December
31, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue: |
|
|
|
|
|
|
|
|
Net sales |
$ |
24,779 |
|
$ |
26,523 |
|
$ |
283,266 |
|
$ |
429,797 |
|
Cost of sales |
|
(46,125 |
) |
|
(22,113 |
) |
|
(373,234 |
) |
|
(396,786 |
) |
Gross profit |
|
(21,346 |
) |
|
4,410 |
|
|
(89,968 |
) |
|
33,011 |
|
Operating
Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
(2,677,007 |
) |
|
4,347,262 |
|
|
(11,052,903 |
) |
|
(18,822,488 |
) |
Selling, general and administrative |
|
(2,678,231 |
) |
|
(2,213,441 |
) |
|
(9,865,005 |
) |
|
(8,074,719 |
) |
Total Operating Expenses |
|
(5,355,238 |
) |
|
2,133,821 |
|
|
(20,917,908 |
) |
|
(26,897,207 |
) |
Income (loss) From
Operations |
|
(5,376,584 |
) |
|
2,138,230 |
|
|
(21,007,876 |
) |
|
(26,864,196 |
) |
Other Income
(Expense): |
|
|
|
|
|
|
|
|
Interest income |
|
75,788 |
|
|
6,235 |
|
|
322,668 |
|
|
36,618 |
|
Foreign exchange transaction loss |
|
2,126 |
|
|
4,052 |
|
|
(21,156 |
) |
|
(179 |
) |
Change in fair value of derivative liability |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
Interest and amortization expense |
|
(6,276 |
) |
|
- |
|
|
(787,488 |
) |
|
(1,873 |
) |
Total Other Income (Expense) |
|
71,638 |
|
|
10,287 |
|
|
(485,976 |
|
|
34,566 |
|
Net Loss Before Income
Taxes |
|
(5,304,946 |
) |
|
2,148,518 |
|
|
(21,493,852 |
) |
|
(26,829,630 |
) |
Tax benefit |
|
- |
|
|
- |
|
|
5,060,778 |
|
|
- |
|
Net Loss |
|
(5,304,946 |
) |
|
2,148,518 |
|
|
(16,433,074 |
) |
|
(26,829,630 |
) |
Other Comprehensive Income (Loss) |
|
(3,308 |
) |
|
5,524 |
|
|
735 |
|
|
(1,911 |
) |
Comprehensive Income
(Loss) |
$ |
(5,308,254 |
) |
$ |
2,154,041 |
|
$ |
(16,432,339 |
) |
$ |
(26,831,541 |
) |
Net loss |
|
(5,304,946 |
) |
|
2,148,518 |
|
|
(16,433,074 |
) |
|
(26,829,630 |
) |
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 |
|
(5,304,946 |
) |
|
2,148,518 |
|
|
(43,535,672 |
) |
|
(26,829,630 |
) |
Net Income (Loss) Per
Common Share – Basic and Diluted |
$ |
(0.21 |
) |
$ |
0.10 |
|
$ |
(1.80 |
) |
$ |
(1.51 |
) |
Weighted Average Common
Shares Outstanding – Basic and Diluted |
|
25,665,619 |
|
|
20,880,195 |
|
|
24,152,088 |
|
|
17,816,624 |
|
CORMEDIX INC. AND
SUBSIDIARYCONSOLIDATED BALANCE SHEETS
|
|
December 31, |
|
December 31, |
|
|
|
2019 |
|
2018 |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
Cash, cash equivalents and
restricted cash |
$ |
16,525,187 |
|
$ |
17,795,323 |
|
|
Short-term investments |
$ |
11,984,157 |
|
$ |
- |
|
|
Total
Assets |
$ |
29,475,910 |
|
$ |
18,825,914 |
|
|
|
|
|
|
|
|
Total
Liabilities |
$ |
5,829,650 |
|
$ |
13,891,658 |
|
|
Accumulated deficit |
$ |
(195,421,172 |
) |
$ |
(178,988,098 |
) |
|
Total Stockholders’
Equity |
$ |
23,646,260 |
|
$ |
4,934,256 |
|
|
CORMEDIX INC. AND
SUBSIDIARYCONSOLIDATED STATEMENTS OF CASH
FLOWS
|
Years Ended December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
Cash Flows From
Operating Activities: |
|
|
|
Net loss |
$ |
(16,433,074 |
) |
|
$ |
(26,829,630 |
) |
Net cash used in operating
activities |
|
(15,052,024 |
) |
|
|
(23,700,565 |
) |
Cash Flows Used In
Investing Activities: |
|
|
|
Net cash used in (provided by)
investing activities |
|
(12,020,459 |
) |
|
|
1,555,414 |
|
Cash Flows From
Financing Activities: |
|
|
|
Net cash provided by financing
activities |
|
25,804,362 |
|
|
|
29,397,070 |
|
Foreign exchange effects on
cash |
|
(2,015 |
) |
|
|
(7,878 |
) |
Net (Decrease)
Increase in Cash and Cash Equivalents |
|
(1,270,136 |
) |
|
|
7,244,041 |
|
Cash and Cash
Equivalents and Restricted Cash - Beginning of Period |
|
17,795,323 |
|
|
|
10,551,282 |
|
Cash -and Cash
Equivalents and Restricted Cash - End of Period |
$ |
16,525,187 |
|
|
$ |
17,795,323 |
|
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