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Press release content from Globe Newswire. The AP news staff was not involved in its creation.
PRESS RELEASE: Paid content from Globe Newswire
Press release content from Globe Newswire. The AP news staff was not involved in its creation.

Tricida Announces Third Quarter 2021 Financial Results

November 8, 2021 GMT

SOUTH SAN FRANCISCO, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its investigational drug candidate, veverimer, a non-absorbed, orally-administered polymer designed to slow chronic kidney disease (CKD) progression in patients with metabolic acidosis and CKD, announced today financial results for the three and nine months ended September 30, 2021 and provided an update on key initiatives.

Update on Key Initiatives:

  • Tricida continued to execute on recruitment and conduct of the VALOR-CKD renal outcomes clinical trial. As of November 5, 2021, the trial has randomized over 1,470 of its planned 1,600 subjects with an average treatment duration of approximately 19 months.   The trial has accrued 159 of the 511 required subjects with positively adjudicated primary endpoint events, defined as renal death, end-stage renal disease (ESRD), and/or greater than or equal to 40% reduction in estimated glomerular filtration rate (eGFR).  
  • There is a substantial likelihood that Tricida will not have adequate resources or be able to obtain such resources on reasonable terms in the necessary timeframe to continue the VALOR-CKD trial to reach the current target of 511 subjects with positively adjudicated primary endpoint events, which we anticipate would not be reached until 2024. As such, Tricida has considered various options to terminate the VALOR-CKD trial early. Tricida requested and was granted a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss approaches to stopping the VALOR-CKD trial early based on financial resources and the procedures for study close-out. Consistent with feedback provided by the FDA in its preliminary comments for the Type A meeting, Tricida believes that, among the alternatives considered, stopping the VALOR-CKD trial early for administrative reasons pursuant to the existing protocol is likely to provide the most complete and interpretable data, reduce the risk of missing data required for key efficacy analyses, and maintain the integrity of the trial. While the exact timing of the administrative stop will be determined by the company’s financial runway, Tricida anticipates that an administrative stop would occur in the first half of 2022. Its goal is to have approximately six months of financial runway upon receipt of the VALOR-CKD data. Also, based on feedback from the FDA, Tricida will halt enrollment of additional patients in the VALOR-CKD trial in order to focus resources on maximizing the duration of follow-up in subjects who are currently enrolled in the trial.

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“Reengaging with the FDA on the topic of how to best stop the VALOR-CKD trial early yielded clear and helpful feedback to ensure interpretability of the resulting data. Even with an early termination, we believe we can address the most important trial objectives,” said Gerrit Klaerner, Ph.D., Tricida’s Chief Executive Officer and President.

Financial Results for the Three and Nine Months Ended September 30, 2021

Research and development expense was $26.6 million and $43.0 million for the three months ended September 30, 2021 and 2020, respectively. The decrease in research and development expense for the three months ended September 30, 2021 compared to the prior year was primarily due to decreased activities in connection with our veverimer clinical development program related to manufacturing process optimization and the manufacturing of drug substance. Research and development expense was $78.6 million and $121.1 million for the nine months ended September 30, 2021 and 2020, respectively. The decrease in research and development expense for the nine months ended September 30, 2021 compared to the prior year was primarily due to decreased activities in connection with our veverimer clinical development program related to manufacturing process optimization and the manufacturing of drug substance and lower personnel costs.

General and administrative expense was $9.1 million and $29.3 million for the three months ended September 30, 2021 and 2020, respectively. The decrease in general and administrative expense for the three months ended September 30, 2021 compared to the prior year was primarily due to decreased administrative activities in connection with our veverimer clinical development program, including pre-commercialization, medical affairs and personnel costs. General and administrative expense was $28.5 million and $81.2 million for the nine months ended September 30, 2021 and 2020, respectively. The decrease in general and administrative expense for the nine months ended September 30, 2021 compared to the prior year was primarily due to decreased administrative activities in connection with our veverimer clinical development program, including pre-commercialization, medical affairs and personnel costs.

Net loss was $39.7 million (non-GAAP net loss of $30.7 million) and $77.7 million (non-GAAP net loss of $64.3 million) for the three months ended September 30, 2021 and 2020, respectively, and $126.6 million (non-GAAP net loss of $93.6 million) and $209.9 million (non-GAAP net loss of $177.0 million) for the nine months ended September 30, 2021 and 2020, respectively. Net loss per basic and diluted share was $0.79 and $1.55 for the three months ended September 30, 2021 and 2020, respectively, and $2.52 and $4.20 for the nine months ended September 30, 2021 and 2020, respectively.

As of September 30, 2021, cash, cash equivalents and investments were $146.8 million.

Financial Guidance

Tricida believes it has financial resources to fund its planned operations through 2022.

Tricida Conference Call Information

Tricida will host its Third Quarter Financial Results and Business Update Conference Call and webcast today at 4:30 pm Eastern Time. The webcast or conference call may be accessed as follows:

Tricida Conference Call
Monday, November 8, 2021
4:30 pm Eastern Time

Webcast:IR.Tricida.com
Dial-in:(877) 377-5478
International:(629) 228-0740
Conference ID:8785726

A replay of the webcast will be available on Tricida’s website approximately two hours following the completion of the call and will be available for up to 90 days following the presentation.

About Tricida

Tricida, Inc. is a pharmaceutical company focused on the development and commercialization of its investigational drug candidate, veverimer, a non-absorbed, orally-administered polymer designed to slow CKD progression in patients with metabolic acidosis and CKD. Tricida is currently conducting a renal outcomes clinical trial, VALOR-CKD, to determine if veverimer slows CKD progression in patients with metabolic acidosis associated with CKD. Metabolic acidosis is a condition commonly caused by CKD that is believed to accelerate the progression of kidney deterioration. There are currently no therapies approved by the FDA to slow progression of kidney disease by correcting chronic metabolic acidosis in patients with CKD. It is estimated to pose a health risk to approximately three million patients with CKD in the United States.

For more information about Tricida, please visit  Tricida.com.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to expectations concerning matters that are not historical facts. Words such as “projects,” “believes,” “anticipates,” “plans,” “expects,” “intends,” “may,” “will,” “could,” “should,” “would,” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, all of the statements under the heading “Update on Key Initiatives” and other statements, including the Company’s plans and expectations with regard to its interactions and communications with the FDA, its plans and expectations for the VALOR-CKD trial, including early termination of the trial, its plans and expectations as to the pathway to approval of veverimer by the FDA and expectations regarding financial runway are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, without limitation, the Company’s plans and expectations with regard to its interactions with the FDA, including the potential resubmission of an NDA for veverimer; the timing of the FDA’s approval of veverimer, if at all; the potential availability of the Accelerated Approval Program and the approvability of veverimer under that program; the Company’s plans and expectations for its VALOR-CKD trial and future clinical and product development milestones; the Company’s contractual and financial obligations to our key suppliers and vendors; the Company’s financial projections and cost estimates; and risks associated with the Company’s business prospects, financial results and business operations.

These and other factors that may affect the Company’s future business prospects, results and operations are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s most recent Annual Report filed on Form 10-K and the subsequently filed Quarterly Report(s) on Form 10-Q. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by applicable law, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results, later events or circumstances or to reflect the occurrence of unanticipated events.

(Financial Tables to Follow)
Tricida, Inc.

Condensed Balance Sheets
(Unaudited)
(In thousands)

  September 30,
2021
  December 31,
2020
Assets
Current assets:   
Cash and cash equivalents$16,988  $137,857 
Short-term investments129,782  171,670 
Prepaid expenses and other current assets4,404  4,488 
Total current assets151,174  314,015 
Long-term investments  22,757 
Property and equipment, net836  1,112 
Operating lease right-of-use assets12,576  13,801 
Total assets$164,586  $351,685 
    
Liabilities and stockholders’ equity   
Current liabilities:   
Accounts payable$3,261  $3,508 
Current operating lease liabilities2,716  2,079 
Accrued expenses and other current liabilities19,754  28,671 
Total current liabilities25,731  34,258 
    
Term Loan, net  76,638 
Convertible Senior Notes, net125,194  118,670 
Non-current operating lease liabilities11,759  13,046 
Other long-term liabilities  202 
Total liabilities162,684  242,814 
    
Stockholders’ equity:   
Preferred stock   
Common stock50  50 
Additional paid-in capital762,317  742,555 
Accumulated other comprehensive income (loss)(77) 64 
Accumulated deficit(760,388) (633,798)
Total stockholders’ equity1,902  108,871 
Total liabilities and stockholders’ equity$164,586  $351,685 

Tricida, Inc.

Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)

  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 2021 2020 2021 2020
Operating expenses:       
Research and development$26,635  $42,996  $78,591  $121,134 
General and administrative9,052  29,273  28,497  81,217 
     Total operating expenses35,687  72,269  107,088  202,351 
Loss from operations(35,687) (72,269) (107,088) (202,351)
Other income (expense), net6  907  155  4,395 
Interest expense(3,994) (6,267) (13,533) (12,043)
Loss on early extinguishment of Term Loan    (6,124)  
Loss before income taxes(39,675) (77,629) (126,590) (209,999)
Income tax benefit (expense)  (36)   50 
Net loss(39,675) (77,665) (126,590) (209,949)
Other comprehensive income (loss):       
Net unrealized gain (loss) on available-for-sale investments, net of tax(15) (431) (141) 239 
Total comprehensive loss$(39,690) $(78,096) $(126,731) $(209,710)
Net loss per share, basic and diluted$(0.79) $(1.55) $(2.52) $(4.20)
Weighted-average number of shares outstanding, basic and diluted50,434,879  50,120,086  50,326,474  49,974,388 

Tricida, Inc.

GAAP to non-GAAP reconciliations
(Unaudited)
(In thousands)

A reconciliation between net loss on a GAAP basis and on a non-GAAP basis is as follows:

  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 2021 2020 2021 2020
GAAP net loss, as reported$(39,675) $(77,665) $(126,590) $(209,949)
Adjustments:       
Non-cash operating lease costs78  207  574  597 
Accretion of Term Loan and Convertible Senior Notes2,243  2,915  7,047  5,246 
Loss on early extinguishment of Term Loan    6,124   
Stock-based compensation6,649  7,655  19,300  25,108 
Changes in fair value of compound derivative liability  (49) (202) (699)
Restructuring costs  2,660  107  2,660 
     Total adjustments8,970  13,388  32,950  32,912 
Non-GAAP net loss$(30,705) $(64,277) $(93,640) $(177,037)

Use of Non-GAAP Financial Measures

We supplement our financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable Securities and Exchange Commission rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss and diluted earnings per share, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

“Non-GAAP net loss” is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude (1) non-cash operating lease costs, (2) accretion of Term Loan and Convertible Senior Notes, (3) loss on early extinguishment of Term Loan, (4) stock-based compensation, (5) changes in fair value of compound derivative liability and (6) restructuring costs, in reconciling of our GAAP to Non-GAAP net loss. Non-GAAP financial measures used by Tricida may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

Contact:
Jackie Cossmon, IRC
Tricida, Inc.
Senior Vice President of
Investor Relations and Communications
IR@Tricida.com