Tricida Announces Second Quarter 2021 Financial Results
Recent Events
Tricida continues to execute on recruitment and conduct of the VALOR-CKD renal outcomes clinical trial. As ofAugust 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
Financial Results for the Three and Six Months Ended
Research and development expense was
General and administrative expense was
Net loss was
As of
Financial Guidance
Tricida Conference Call Information
Tricida Conference Call | |
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.
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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
(Financial Tables to Follow)
Condensed Balance Sheets
(Unaudited)
(In thousands)
2021 |
|||||||
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 |
Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended |
Six Months Ended |
||||||||||||||
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 |
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 |
Six Months Ended |
||||||||||||||
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
“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
Contact:
Senior Vice President of
Investor Relations and Communications
IR@Tricida.com

Source: Tricida, Inc.