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 six months ended June 30, 2021 and provided an update on key initiatives.

Recent Events

  • Tricida continues to execute on recruitment and conduct of the VALOR-CKD renal outcomes clinical trial. As of August 6, 2021, the VALOR-CKD trial had randomized 1,455 of the planned 1,600 subjects, with an average treatment duration of approximately 17 months and had accrued 127 of the 511 required subjects with a positively adjudicated primary endpoint event, defined as the time to first occurrence of renal death, end-stage renal disease (ESRD) or a confirmed greater than or equal to 40% reduction in eGFR (DD40). A pre-specified interim analysis for early stopping for efficacy of the VALOR-CKD trial is currently planned to occur when 250 events have been positively adjudicated by the independent blinded VALOR-CKD Clinical Endpoint Adjudication Committee. Tricida notes that a previously planned 150-event interim analysis has been removed from the VALOR-CKD trial protocol to preserve statistical and regulatory optionality.
  • Tricida completed an updated assessment of the commercial market opportunity for veverimer based on anticipated outcomes data from the VALOR-CKD trial related to slowing CKD progression versus its prior market assessment which was based on surrogate biomarker data (i.e., serum bicarbonate). When shown a target product profile for veverimer which included DD40 outcomes data, physician respondents expressed a strong interest in prescribing veverimer, with over 90 percent of nephrologists and over 70 percent of non-nephrologists, including primary care physicians, cardiologists and endocrinologists, indicating that they “Definitely or Probably Would Prescribe Veverimer.”  In addition, survey results indicate peak patient penetration for prescribing veverimer to be approximately 75% among nephrologists and over 55% among non-nephrologists.
  • Tricida is assessing future development pathways for veverimer in an expanded population, including patients with CKD and latent acidosis. Latent acidosis, also known as eubicarbonatemic acidosis, describes a condition where the deleterious effects of acid accumulation may lead to impaired kidney, bone and muscle health prior to a decline in serum bicarbonate levels and a traditional diagnosis of metabolic acidosis.

Upcoming Milestones

  • Tricida anticipates the VALOR-CKD trial pre-specified interim analysis for early stopping for efficacy in mid-2022, when 250 subjects are expected to have experienced DD40 events. If the independent unblinded Interim Analysis Committee does not recommend stopping the trial early for efficacy, Tricida will receive no information from this interim analysis.

“We continue to focus on our goal to generate outcome data from the VALOR-CKD trial, which we believe could serve as the basis for resubmission of our NDA,” said Gerrit Klaerner, Ph.D., Tricida’s Chief Executive Officer and President.

Financial Results for the Three and Six Months Ended June 30, 2021

Research and development expense was $19.8 million and $28.8 million for the three months ended June 30, 2021 and 2020, respectively. The decrease in research and development expense for the three months ended June 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. Research and development expense was $52.0 million and $78.1 million for the six months ended June 30, 2021 and 2020, respectively. The decrease in research and development expense for the six months ended June 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 $9.6 million and $28.4 million for the three months ended June 30, 2021 and 2020, respectively. The decrease in general and administrative expense for the three months ended June 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 $19.4 million and $51.9 million for the six months ended June 30, 2021 and 2020, respectively. The decrease in general and administrative expense for the six months ended June 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 $33.6 million (non-GAAP net loss of $24.6 million) and $58.2 million (non-GAAP net loss of $48.9 million) for the three months ended June 30, 2021 and 2020, respectively, and $86.9 million (non-GAAP net loss of $62.9 million) and $132.3 million (non-GAAP net loss of $112.8 million) for the six months ended June 30, 2021 and 2020, respectively. Net loss per basic and diluted share was $0.67 and $1.16 for the three months ended June 30, 2021 and 2020, respectively, and $1.73 and $2.65 for the six months ended June 30, 2021 and 2020, respectively.

As of June 30, 2021, cash, cash equivalents and investments were $175.8 million.

Financial Guidance

Tricida believes it has financial resources to fund its planned operations into late 2022. Based on the current rate of primary endpoint events in the VALOR-CKD trial, the 250-event interim analysis for early stopping for efficacy of the trial is expected to occur within the time frame of our existing capital. If we are compelled to stop the trial early for administrative reasons, that event could occur prior to the planned 250-event interim analysis.

Tricida Conference Call Information

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

Tricida Conference Call
   
Monday, August 9, 2021
   
4:30 pm Eastern Time
   
Webcast:  IR.Tricida.com 
   
Dial-In:  (877) 377-5478
   
International: (629) 228-0740
   
Conference ID:  9679330

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 (also known as TRC101), 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 headings “Recent Events,” “Upcoming Milestones” and “Financial Guidance” and other statements, including the Company’s plans and expectations regarding event accrual rates for the VALOR-CKD renal outcomes clinical trial, its plans for interactions and communications with the FDA, its plans and expectations as to the pathway to approval of veverimer by the FDA, if at all, its assessment of potential clinical development pathways for veverimer, its assessment of the future market potential for veverimer and its 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 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 with regard to its interactions with the FDA, including the potential resubmission of an NDA for veverimer; the Company’s plans and expectations for future clinical and product development milestones; the Company’s contractual and financial obligations to its key suppliers and vendors; the Company’s financial projections and cost estimates; risks associated with the COVID-19 pandemic; risks associated with the Company’s business prospects, financial results and business operations; risks related to the Company’s ability to retain its key employees and executives; and risks related to the Company’s capital requirements and ability to raise sufficient funds for its 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 (SEC), including the Company’s most recent Annual Report filed on Form 10-K and its subsequently filed Quarterly Reports 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)

  June 30,2021   December 31, 2020
Assets
Current assets:      
Cash and cash equivalents $ 22,865     $ 137,857  
Short-term investments 152,901     171,670  
Prepaid expenses and other current assets 5,261     4,488  
Total current assets 181,027     314,015  
Long-term investments     22,757  
Property and equipment, net 934     1,112  
Operating lease right-of-use assets 12,987     13,801  
Total assets $ 194,948     $ 351,685  
       
Liabilities and stockholders’ equity      
Current liabilities:      
Accounts payable $ 2,738     $ 3,508  
Current operating lease liabilities 2,608     2,079  
Accrued expenses and other current liabilities 19,522     28,671  
Total current liabilities 24,868     34,258  
       
Term Loan, net     76,638  
Convertible Senior Notes, net 122,951     118,670  
Non-current operating lease liabilities 12,200     13,046  
Other long-term liabilities     202  
Total liabilities 160,019     242,814  
       
Stockholders’ equity:      
Preferred stock      
Common stock 50     50  
Additional paid-in capital 755,654     742,555  
Accumulated other comprehensive income (loss) (62 )   64  
Accumulated deficit (720,713 )   (633,798 )
Total stockholders’ equity 34,929     108,871  
Total liabilities and stockholders’ equity $ 194,948     $ 351,685  

Tricida, Inc.

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

  Three Months EndedJune 30,   Six Months EndedJune 30,
  2021   2020   2021   2020
Operating expenses:              
Research and development $ 19,781     $ 28,757     $ 51,956     $ 78,138  
General and administrative 9,550     28,418     19,445     51,944  
    Total operating expenses 29,331     57,175     71,401     130,082  
Loss from operations (29,331 )   (57,175 )   (71,401 )   (130,082 )
Other income (expense), net (296 )   2,675     149     3,488  
Interest expense (3,926 )   (3,756 )   (9,539 )   (5,776 )
Loss on early extinguishment of Term Loan         (6,124 )    
Loss before income taxes (33,553 )   (58,256 )   (86,915 )   (132,370 )
Income tax benefit (expense)     86         86  
Net loss (33,553 )   (58,170 )   (86,915 )   (132,284 )
Other comprehensive income (loss):              
Net unrealized gain (loss) on available-for-sale investments, net of tax (21 )   902     (126 )   670  
Total comprehensive loss $ (33,574 )   $ (57,268 )   $ (87,041 )   $ (131,614 )
Net loss per share, basic and diluted $ (0.67 )   $ (1.16 )   $ (1.73 )   $ (2.65 )
Weighted-average number of shares outstanding, basic and diluted 50,294,787     49,960,072     50,271,373     49,900,739  

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 EndedJune 30,   Six Months EndedJune 30,
  2021   2020   2021   2020
GAAP net loss, as reported $ (33,553 )   $ (58,170 )   $ (86,915 )   $ (132,284 )
Adjustments:              
Non-cash operating lease costs 248     70     496     390  
Accretion of Term Loan and Convertible Senior Notes 2,176     1,580     4,804     2,331  
Loss on early extinguishment of Term Loan         6,124      
Stock-based compensation 6,609     9,079     12,651     17,453  
Changes in fair value of compound derivative liability     (1,496 )   (202 )   (650 )
Restructuring costs (113 )       107      
    Total adjustments 8,920     9,233     23,980     19,524  
Non-GAAP net loss $ (24,633 )   $ (48,937 )   $ (62,935 )   $ (112,760 )

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, IRCTricida, Inc.Senior Vice President of Investor Relations and CommunicationsIR@Tricida.com 

 

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