CORMEDIX INC. REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Company in process of submitting New Drug Application (NDA) for Neutrolin® for prevention
of catheter-related blood stream infections via a rolling review granted by FDA
Conference Call Scheduled for Today at 4:30 p.m. Eastern Time
Berkeley Heights, NJ – March 16, 2020 – 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. - 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 missioncritical
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: