Full Press Release Details
INC. REPORTS Second QUARTER and six month 2019 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Call Scheduled for Today at 4:30 p.m. Eastern Time
Heights, NJ - August 13, 2019 - 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 second quarter and six months ended June 30, 2019 and provided an update on recent developments.
Corporate and Clinical Highlights:
Khoso Baluch, CorMedix CEO commented, "We have
made significant progress on our goal of bringing Neutrolin to the U.S. market as a catheter lock solution for hemodialysis. We
have been in active communication with the FDA over the last several quarters and believe that the data from our Phase 3 LOCK-IT-100
study are sufficient for FDA review and potential approval, eliminating the need for a second Phase 3 study. Our focus now turns
to making sure that we have all of the data and information required to file an NDA and obtain marketing approval. We also are
making necessary preparations for the launch of Neutrolin in the U.S. hemodialysis market, including the steps necessary to build
a world-class commercialization program. We believe we have the team, the focus, and a therapy that will meaningfully improve
patient outcomes and are excited about the opportunity in front of us."
Quarter and Six Month 2019 Financial Highlights
second quarter 2019, CorMedix recorded a net loss of $0.7 million, or $0.03 per share, compared with a net loss of $8.6 million,
or $0.52 per share, in the second quarter of 2018, a decrease of $7.9 million. During the second quarter of 2019, the Company
recorded a tax benefit of $5.1 million resulting from the sale of $5.4 million of its New Jersey Net Operating Losses. R&D
expenses declined significantly, while SG&A expense increased, partially offsetting the reduction in R&D.
expenses in the second quarter of 2019 declined 35% to $5.5 million, compared with $8.5 million in the second quarter of 2018.
R&D expense declined approximately 55% to $3.0 million from $6.6 million, mainly due to a $4.7 million decrease in clinical
trial expense, partially offset by a $1 million increase in CMC-related activities. SG&A expense increased 32% to $2.6 million
compared with $1.9 million in the second quarter of 2018. Higher compliance expenses, staffing, consulting and marketing expenses
were partially offset by a reduction in legal fees, patents, and investor relations expenses.
the six months ended June 30, 2019, CorMedix recorded a net loss of $5.9 million, or $0.25 per share, compared with a net loss
of $18.7 million, or $1.19 per share, in the first half of 2018, a decrease of $12.8 million. The decrease in net loss in the
first half of 2019 compared with the first half of 2018 was driven primarily by decreased costs related to the winding down of
the LOCK-IT-100 clinical study and the tax benefit derived from the sale of the Company's New Jersey Net Operating Losses.
expenses in the first half of 2019 were $10.4 million, compared to $18.7 million in the first half of 2018, a decrease of approximately
44%. This decrease was due primarily to a $9.0 million, or 60%, decrease in R&D expense, while SG&A expense increased
cash on hand and short-term investments as of June 30, 2019 was $26.4 million, excluding restricted cash of $0.2 million. The
Company believes that, based on the Company's cash resources at June 30, 2019, it has sufficient resources to fund operations
into the third quarter of 2020, including the submission of the New Drug Application for Neutrolin and initial preparations for
management team of CorMedix will host a conference call and webcast today, August 13, 2019, at 4:30 PM Eastern Time, to discuss
recent corporate developments and financial results. Call details and dial-in information is as follows:
| Domestic: | 844-602-0380 |
| International: | 862-298-0970 |
| Passcode: | 55784708 |
| Webcast: | https://www.investornetwork.com/event/presentation/51874 |
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
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. 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.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenue: | ||||||||||||||||
| Net sales | $ | 35,266 | $ | 7,551 | $ | 198,958 | $ | 30,760 | ||||||||
| Cost of sales | (21,128 | ) | (33,663 | ) | (248,083 | ) | (62,238 | ) | ||||||||
| Gross profit (loss) | 14,138 | (26,112 | ) | (49,125 | ) | (31,478 | ) | |||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | (2,979,907 | ) | (6,600,213 | ) | (5,854,903 | ) | (14,880,657 | ) | ||||||||
| Selling, general and administrative | (2,571,587 | ) | (1,945,825 | ) | (4,556,509 | ) | (3,848,838 | ) | ||||||||
| Total Operating Expenses | (5,551,494 | ) | (8,546,038 | ) | (10,411,412 | ) | (18,729,495 | ) | ||||||||
| Loss From Operations | (5,537,356 | ) | (8,572,150 | ) | (10,460,537 | ) | (18,760,973 | ) | ||||||||
| Other Income (Expense): | ||||||||||||||||
| Interest income | 95,964 | 10,196 | 154,785 | 24,971 | ||||||||||||
| Foreign exchange transaction gain (loss) | (8,808 | ) | 5,043 | (10,285 | ) | (4,154 | ) | |||||||||
| Interest expense, including amortization of debt discount | (306,736 | ) | - | (608,783 | ) | (1,873 | ) | |||||||||
| Total Other Income (Expense) | (219,580 | ) | 15,239 | (464,283 | ) | 18,944 | ||||||||||
| Loss before income taxes | (5,756,936 | ) | (8,556,911 | ) | (10,924,820 | ) | (18,742,029 | ) | ||||||||
| Tax benefit | 5,060,778 | - | 5,060,778 | - | ||||||||||||
| Net Loss | (696,158 | ) | (8,556,911 | ) | (5,864,042 | ) | (18,742,029 | ) | ||||||||
| Other Comprehensive Income (Loss): | ||||||||||||||||
| Unrealized gain from investments | 8,846 | - | 7,839 | - | ||||||||||||
| Foreign currency translation gain (loss) | 285 | 395 | (21 | ) | (1,030 | ) | ||||||||||
| Total Other Comprehensive Income (Loss) | 9,131 | 395 | 7,818 | (1,030 | ) | |||||||||||
| Comprehensive Loss | $ | (687,027 | ) | $ | (8,556,516 | ) | $ | (5,856,224 | ) | $ | (18,743,059 | ) | ||||
| Net Loss Per Common Share - Basic and Diluted | $ | (0.03 | ) | $ | (0.52 | ) | $ | (0.25 | ) | $ | (1.19 | ) | ||||
| Weighted Average Common Shares Outstanding - Basic and Diluted | 23,825,773 | 16,470,865 | 23,451,988 | 15,738,605 |
CONDENSED CONSOLIDATED
| June 30, 2019 | December 31, 2018 | |||||||
| Assets | ||||||||
| Cash, cash equivalents and restricted cash | $ | 14,733,383 | $ | 17,795,323 | ||||
| Short-term investments | $ | 11,824,642 | $ | - | ||||
| Total Assets | $ | 27,559,206 | $ | 18,825,914 | ||||
| Total Liabilities | $ | 11,084,155 | $ | 13,891,658 | ||||
| Accumulated deficit | $ | (184,852,140 | ) | $ | (178,988,098 | ) | ||
| Total Stockholders' Equity | $ | 16,475,051 | $ | 4,934,256 |
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOW DATA
| Six Month Periods Ended June 30, | ||||||||
| 2019 | 2018 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (5,864,042 | ) | $ | (18,742,029 | ) | ||
| Net cash used in operating activities | (7,203,015 | ) | (11,389,784 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Net cash (used in) provided by investing activities | (11,839,528 | ) | 1,565,973 | |||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from sale of common stock from at-the-market program | 15,234,529 | 4,149,713 | ||||||
| Proceeds from exercise of warrants | 634,062 | - | ||||||
| Proceeds from exercise of stock options | 112,766 | - | ||||||
| Net cash provided by financing activities | 15,981,357 | 4,149,713 | ||||||
| Net Decrease in Cash | (3,061,940 | ) | (5,677,751 | ) | ||||
| Cash - Beginning of Period | 17,795,323 | 10,551,282 | ||||||
| Cash - End of Period | $ | 14,733,383 | $ | 4,873,531 |