CoreMedix Earnings. Should You Buy?

 

CorMedix Inc. (Nasdaq: 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, 2020 and provided an update on recent business developments.

Recent Corporate Highlights:

   -- CorMedix announced in early March 2021 that the US Food and Drug 
      Administration (FDA) cannot approve the New Drug Application (NDA) for 
      DefenCath in its present form.  FDA noted concerns at the third-party 
      manufacturing facility after a review of records requested by FDA and 
      provided by the manufacturing facility, and has requested a manual 
      extraction study to demonstrate that the labeled volume can be 
      consistently withdrawn from vials. 
 
   -- CorMedix continues to work closely with our third-party manufacturing 
      facility and is planning for a meeting with the FDA in mid-April to 
      obtain agreement on the adequacy of our proposed plans for resolution of 
      the deficiencies. 
 
   -- CorMedix transitioned to Nasdaq in early February 2021, which has become 
      the primary trading platform for biopharmaceutical peers and other growth 
      companies. 
 
   -- CorMedix has strengthened its balance sheet via equity financing activity 
      over the past year and early 2021. 
 
   -- CorMedix has been approved by the New Jersey Economic Development 
      Authority (NJEDA) to transfer substantially all of the $1.3 million of 
      its available tax benefits to an unrelated, profitable New Jersey 
      corporation pursuant to the New Jersey Technology Business Tax 
      Certificate Transfer (NOL) program for State Fiscal Year 2020, for 
      approximately $1.3 million in net proceeds.  Closing is anticipated in 2Q 
      of 2021.

Khoso Baluch, CorMedix CEO commented, “While we were disappointed that the DefenCath NDA was not approved at its PDUFA date, we remain confident in our efforts to bring DefenCath to hemodialysis patients as an important novel antimicrobial catheter lock solution to reduce catheter related blood stream infections in patients receiving hemodialysis via central venous catheters. We believe we have the right team and resources to accomplish this as we advance DefenCath closer to regulatory approval.”

4(th) Quarter 2020 Financial Highlights

For the fourth quarter of 2020, CorMedix recorded a net loss of $6.1 million, or $0.19 per share, compared with a net loss of $5.3 million, or $0.21 per share, in the fourth quarter of 2019, an increase in net loss of $0.8 million. The increase in net loss in the fourth quarter of 2020 compared with 2019 was primarily driven by increases in employee costs and market research costs. Operating expenses during the fourth quarter of 2020 were $6.1 million, compared with $5.4 million in the fourth quarter of 2019, an increase of approximately $0.7 million.

Full Year 2020 Financial Highlights

For the year ended December 31, 2020, CorMedix recorded a net loss of $22.0 million, or $0.77 per share, compared with a net loss during the year ended December 31, 2019 of $16.4 million before recognition of deemed dividends, or $0.68 per share, an increase in net loss of $5.6 million. The increase in net loss was driven primarily by increases in operating expenses.

Operating expenses during the year ended December 31, 2020 amounted to $27.3 million compared with $20.9 million during the comparable period in 2019, an increase of $6.4 million, or 30%, due to a 21% increase in R&D expense and 41% increase in SG&A expense.

Total cash on hand and short-term investments as of December 31, 2020 amounted to $46.3 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at year end plus the $41.5 million in net proceeds from ATM issuances since the beginning of 2021, it has sufficient resources to fund operations at least into the second half of 2022.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, March 30, 2021, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

Tuesday, March 30(th) @ 4:30pm ET

Domestic: 877-423-9813

International: 201-689-8573

Conference ID: 13715664

Webcast: Webcast Link

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 DefenCath(TM), a novel, antibacterial and antifungal 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, which provides 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 intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with 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. Neutrolin(R) is CE Marked and marketed in Europe and other territories as a medical device. 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 DefenCath development path for marketing authorization; the resources needed to secure approval of the new drug application for DefenCath from 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 DefenCath/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. We continue to assess 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 Ferry

Managing Director

LifeSci Advisors

(617) 430-7576

CORMEDIX INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

AND COMPREHENSIVE INCOME (LOSS)

(Audited)

 
                      For the Three Months           For the Years Ended 
                       Ended December 31,                December 31, 
                    -------------------------   ----------------------------- 
                       2020          2019          2020           2019 
Revenue: 
  Net sales        $    55,713   $    24,779   $    239,231   $    283,266 
  Cost of sales        (57,233)      (46,125)      (204,846)      (373,234) 
                    ----------    ---------- 
     Gross profit       (1,520)      (21,346)        34,385        (89,968) 
                    ----------    ----------    -----------    ----------- 
Operating 
Expenses: 
  Research and 
   development      (2,294,430)   (2,677,007)   (13,377,193)   (11,052,903) 
  Selling, 
   general and 
   administrative   (3,788,690)   (2,677,470)   (13,877,944)    (9,865,005) 
                    ----------    ----------    -----------    ----------- 
     Total 
      Operating 
      Expenses      (6,083,120)   (5,354,477)   (27,255,137)   (20,917,908) 
                    ----------    ----------    -----------    ----------- 
Income (loss) 
 From Operations    (6,084,640)   (5,375,823)   (27,220,752)   (21,007,876) 
                    ----------    ----------    -----------    ----------- 
Other Income 
(Expense): 
  Interest income        2,940        75,788        116,065        322,668 
  Foreign 
   exchange 
   transaction 
   loss                     76         2,126        (59,165)       (21,156) 
  Change in fair 
  value of 
  derivative 
  liability                  -             -              -              - 
  Interest and 
   amortization 
   expense              (5,322)       (6,276)       (33,226)      (787,488) 
                    ----------    ----------    -----------    ----------- 
     Total Other 
      Income

2021-03-30 20:05:00 GMT CorMedix Inc. Reports Fourth Quarter and Full -2-

      (Expense)         (2,306)       71,638         23,674       (485,976) 
                    ----------    ----------    -----------    ----------- 
Net Loss Before 
 Income Taxes       (6,086,946)   (5,304,185)   (27,197,078)   (21,493,852) 
  Tax benefit                -             -      5,169,395      5,060,778 
                    ----------    ----------    -----------    ----------- 
Net Loss            (6,086,946)   (5,304,185)   (22,027,683)   (16,433,074) 
  Other 
   Comprehensive 
   Income (Loss)         2,347        (4,745)         4,749            735 
                    ----------    ----------    -----------    ----------- 
Comprehensive 
 Income (Loss)     $(6,084,599)  $(5,308,930)  $(22,022,934)  $(16,432,339) 
                    ==========    ==========    ===========    =========== 
Net loss            (6,086,946)   (5,304,185)   (22,027,683)   (16,433,074) 
  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       (6,086,946)   (5,304,185)   (22,027,683)   (43,535,672) 
                    ==========    ==========    ===========    =========== 
Net Income (Loss) 
 Per Common Share 
 -- Basic and 
 Diluted           $     (0.19)  $     (0.21)  $      (0.77)  $      (1.80) 
                    ==========    ==========    ===========    =========== 
Weighted Average 
 Common Shares 
 Outstanding -- 
 Basic and 
 Diluted            32,402,336    25,665,619     28,561,963     24,152,088 
                    ==========    ==========    ===========    =========== 

CORMEDIX INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Audited)

 
                                      December 31,     December 31, 
                                         2020             2019 
 
ASSETS 
Cash, cash equivalents and 
 restricted cash                    $   42,096,783   $   16,525,187 
Short-term investments              $    4,444,072   $   11,984,157 
Total Assets                        $   49,308,303   $   29,475,910 
 
Total Liabilities                   $    5,085,291   $    5,829,650 
Accumulated deficit                 $ (217,448,855)  $ (195,421,172) 
Total Stockholders' Equity          $   44,223,012   $   23,646,260 

CORMEDIX INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Audited)

 
                                            Years Ended December 31, 
                                         ----------------------------- 
                                            2020           2019 
 
Cash Flows From Operating Activities: 
Net loss                                $(22,027,683)  $(16,433,074) 
Net cash used in operating activities    (21,967,638)   (15,052,024) 
Cash Flows Used In Investing 
Activities: 
Net cash used in (provided by) 
 investing activities                      7,426,176    (12,020,459) 
Cash Flows From Financing Activities: 
Net cash provided by financing 
 activities                               40,099,866     25,804,362 
Foreign exchange effects on cash              13,192         (2,015) 
Net Increase (Decrease) in Cash and 
 Cash Equivalents                         25,571,596     (1,270,136) 
Cash and Cash Equivalents and 
 Restricted Cash - Beginning of 
 Period                                   16,525,187     17,795,323 
Cash -and Cash Equivalents and 
 Restricted Cash - End of Period        $ 42,096,783   $ 16,525,187 

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