Tricida Announces First Quarter 2022 Financial Results
Business Update
Tricida continued to execute on the conduct of the VALOR-CKD renal outcomes clinical trial. Enrollment of patients in the VALOR-CKD trial was completed at the end of 2021 with 1,480 subjects randomized. As ofMay 9, 2022 , randomized subjects had an average treatment duration of approximately 25 months, and the trial had accrued 233 subjects with positively adjudicated primary endpoint events, defined as renal death, end-stage renal disease (ESRD), or greater than or equal to 40% reduction in estimated glomerular filtration rate (eGFR).
Upcoming Milestone
Tricida previously reported that based on its financial runway it intends to stop the VALOR-CKD trial early for administrative reasons in the second quarter of 2022, with continued accrual of primary endpoint events into the third quarter of 2022. Based on the current event rate trend,Tricida anticipates there will be 250 to 270 subjects with positively adjudicated primary endpoint events in the final analysis. The reporting of top-line results from the VALOR-CKD trial is anticipated to occur early in the fourth quarter of 2022, which would allow for approximately six months of financial runway following the announcement.
“We have seen a steady increase in primary endpoint events in the VALOR-CKD trial and continue to believe that we will obtain interpretable data to evaluate how treatment with veverimer impacts slowing of CKD progression in patients with metabolic acidosis and CKD,” said
Financial Results for the Three Months Ended
Research and development expense was
General and administrative expense was
Net loss was
As of
Financial Guidance
Tricida Conference Call Information
Tuesday, May 10, 2022
Webcast: | IR.Tricida.com | ||
Dial-in: | (877) 377-5478 | ||
International: | (629) 228-0740 | ||
Conference ID: | 1650033 |
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 heading “Upcoming Milestone” and other statements, including the Company’s plans and expectations for the VALOR-CKD trial, including early termination of the trial, event accrual rates for the trial and the estimated timing for receipt of top-line data, and its expectations regarding financial runway. Forward-looking statements 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 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; the Company’s ability to raise additional funds; risks associated with the ongoing conflict in
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)
2022 |
2021 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 17,712 | $ | 21,113 | |||
Short-term investments | 106,014 | 119,419 | |||||
Prepaid expenses and other current assets | 4,269 | 5,004 | |||||
Total current assets | 127,995 | 145,536 | |||||
Long-term investments | — | 10,043 | |||||
Property and equipment, net | 688 | 769 | |||||
Operating lease right-of-use assets | 11,731 | 12,158 | |||||
Total assets | $ | 140,414 | $ | 168,506 | |||
Liabilities and stockholders’ equity (deficit) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 5,535 | $ | 10,023 | |||
Current operating lease liabilities | 2,756 | 2,736 | |||||
Accrued expenses and other current liabilities | 16,703 | 16,721 | |||||
Total current liabilities | 24,994 | 29,480 | |||||
Convertible Senior Notes, net | 194,894 | 127,512 | |||||
Non-current operating lease liabilities | 10,826 | 11,296 | |||||
Total liabilities | 230,714 | 168,288 | |||||
Stockholders’ equity (deficit): | |||||||
Preferred stock | — | — | |||||
Common stock | 55 | 55 | |||||
Additional paid-in capital | 737,685 | 810,618 | |||||
Accumulated other comprehensive income (loss) | (377 | ) | (91 | ) | |||
Accumulated deficit | (827,663 | ) | (810,364 | ) | |||
Total stockholders’ equity (deficit) | (90,300 | ) | 218 | ||||
Total liabilities and stockholders’ equity | $ | 140,414 | $ | 168,506 | |||
Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended |
|||||||
2022 | 2021 | ||||||
Operating expenses: | |||||||
Research and development | $ | 18,504 | $ | 32,175 | |||
General and administrative | 9,170 | 9,895 | |||||
Total operating expenses | 27,674 | 42,070 | |||||
Loss from operations | (27,674 | ) | (42,070 | ) | |||
Other income (expense), net | 8 | 445 | |||||
Interest expense | (1,973 | ) | (5,613 | ) | |||
Loss on early extinguishment of Term Loan | — | (6,124 | ) | ||||
Net loss | (29,639 | ) | (53,362 | ) | |||
Other comprehensive income (loss): | |||||||
Net unrealized gain (loss) on available-for-sale investments, net of tax | (286 | ) | (105 | ) | |||
Total comprehensive loss | $ | (29,925 | ) | $ | (53,467 | ) | |
Net loss per share, basic and diluted | $ | (0.51 | ) | $ | (1.06 | ) | |
Weighted-average number of shares outstanding, basic and diluted | 57,718,979 | 50,247,698 | |||||
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 |
|||||||
2022 | 2021 | ||||||
GAAP net loss, as reported | $ | (29,639 | ) | $ | (53,362 | ) | |
Adjustments: | |||||||
Non-cash operating lease costs | (24 | ) | 248 | ||||
Accretion of Term Loan and Convertible Senior Notes | 223 | 2,628 | |||||
Loss on early extinguishment of Term Loan | — | 6,124 | |||||
Stock-based compensation | 6,524 | 6,042 | |||||
Changes in compound derivative liability | — | (202 | ) | ||||
Restructuring costs | — | 220 | |||||
Total adjustments | 6,723 | 15,060 | |||||
Non-GAAP net loss | $ | (22,916 | ) | $ | (38,302 | ) | |
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 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.