Tricida Announces Second Quarter 2022 Financial Results
Tricida, Inc. (Nasdaq: TCDA) announced its Q2 2022 financial results, reporting a net loss of $28.5 million, a decrease from $33.6 million in Q2 2021. Research and development expenses fell to $16.9 million from $19.8 million due to reduced costs from the halted VALOR-CKD trial. General and administrative expenses rose slightly to $9.8 million. The company has $98.7 million in cash reserves, sufficient to fund operations until early Q2 2023. Top-line results from the VALOR-CKD trial are expected in October 2022.
- Net loss decreased to $28.5 million in Q2 2022 from $33.6 million in Q2 2021.
- Research and development expenses dropped to $16.9 million in Q2 2022, down from $19.8 million in Q2 2021.
- Company has $98.7 million in cash, expected to fund operations into early Q2 2023.
- Net loss per share increased to $0.49 in Q2 2022 from $0.67 in Q2 2021.
- Reduced clinical development costs due to the stoppage of the VALOR-CKD trial could indicate operational challenges.
Webcast Today at
Business Update
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Tricida announced inMay 2022 that it stopped its VALOR-CKD renal outcomes trial early for administrative reasons as permitted by the existing study protocol to allow for six months of financial runway following the reporting of top-line results, which is anticipated to occur inOctober 2022 . -
The VALOR-CKD trial has continued to accrue primary endpoint events as clinical trial subjects complete their participation in the study which, for the last subject, is currently projected to occur in the third quarter of 2022. As of
August 8, 2022 , the 1480 subjects who were randomized in the VALOR-CKD trial had an average treatment duration of approximately 26.5 months, and the trial had accrued 281 subjects with positively adjudicated primary endpoint events, defined as renal death, end-stage renal disease (ESRD), or greater than or equal to40% reduction in estimated glomerular filtration rate (eGFR). -
Based on the current event rate trend,
Tricida is increasing its estimate of the number of subjects with positively adjudicated primary endpoint events in the final VALOR-CKD trial analysis to 285 to 295.
Upcoming Milestone
-
Tricida anticipates reporting top-line results of the VALOR-CKD trial inOctober 2022 .
“We are really proud of our
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 Second Quarter Financial Results Conference Call
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Webcast: | ||||
Dial In: | (800) 715-9871 |
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International: | (646) 307-1963 |
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Conference ID: | 3576787 |
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 “Business Update” and “Upcoming Milestone” and other statements, including the Company’s plans and expectations for the VALOR-CKD trial, including 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 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
Condensed Balance Sheets (Unaudited) (In thousands) |
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Assets |
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Current assets: |
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|
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Cash and cash equivalents |
$ |
22,152 |
|
|
$ |
21,113 |
|
Short-term investments |
|
76,543 |
|
|
|
119,419 |
|
Prepaid expenses and other current assets |
|
3,685 |
|
|
|
5,004 |
|
Total current assets |
|
102,380 |
|
|
|
145,536 |
|
Long-term investments |
|
— |
|
|
|
10,043 |
|
Property and equipment, net |
|
611 |
|
|
|
769 |
|
Operating lease right-of-use assets |
|
11,297 |
|
|
|
12,158 |
|
Total assets |
$ |
114,288 |
|
|
$ |
168,506 |
|
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|
|
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Liabilities and stockholders’ equity (deficit) |
|
|
|
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Current liabilities: |
|
|
|
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Accounts payable |
$ |
3,740 |
|
|
$ |
10,023 |
|
Current operating lease liabilities |
|
2,777 |
|
|
|
2,736 |
|
Accrued expenses and other current liabilities |
|
13,530 |
|
|
|
16,721 |
|
Total current liabilities |
|
20,047 |
|
|
|
29,480 |
|
|
|
|
|
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Convertible Senior Notes, net |
|
195,119 |
|
|
|
127,512 |
|
Non-current operating lease liabilities |
|
10,346 |
|
|
|
11,296 |
|
Total liabilities |
|
225,512 |
|
|
|
168,288 |
|
|
|
|
|
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Stockholders’ equity (deficit): |
|
|
|
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Preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
56 |
|
|
|
55 |
|
Additional paid-in capital |
|
745,394 |
|
|
|
810,618 |
|
Accumulated other comprehensive income (loss) |
|
(475 |
) |
|
|
(91 |
) |
Accumulated deficit |
|
(856,199 |
) |
|
|
(810,364 |
) |
Total stockholders’ equity (deficit) |
|
(111,224 |
) |
|
|
218 |
|
Total liabilities and stockholders’ equity (deficit) |
$ |
114,288 |
|
|
$ |
168,506 |
|
Condensed Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except share and per share amounts) |
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Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Research and development |
$ |
16,859 |
|
|
$ |
19,781 |
|
|
$ |
35,363 |
|
|
$ |
51,956 |
|
General and administrative |
|
9,824 |
|
|
|
9,550 |
|
|
|
18,994 |
|
|
|
19,445 |
|
Total operating expenses |
|
26,683 |
|
|
|
29,331 |
|
|
|
54,357 |
|
|
|
71,401 |
|
Loss from operations |
|
(26,683 |
) |
|
|
(29,331 |
) |
|
|
(54,357 |
) |
|
|
(71,401 |
) |
Other income (expense), net |
|
123 |
|
|
|
(296 |
) |
|
|
131 |
|
|
|
149 |
|
Interest expense |
|
(1,976 |
) |
|
|
(3,926 |
) |
|
|
(3,949 |
) |
|
|
(9,539 |
) |
Loss on early extinguishment of Term Loan |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,124 |
) |
Net loss |
|
(28,536 |
) |
|
|
(33,553 |
) |
|
|
(58,175 |
) |
|
|
(86,915 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
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Net unrealized gain (loss) on available-for-sale investments, net of tax |
|
(98 |
) |
|
|
(21 |
) |
|
|
(384 |
) |
|
|
(126 |
) |
Total comprehensive loss |
$ |
(28,634 |
) |
|
$ |
(33,574 |
) |
|
$ |
(58,559 |
) |
|
$ |
(87,041 |
) |
Net loss per share, basic and diluted |
$ |
(0.49 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.01 |
) |
|
$ |
(1.73 |
) |
Weighted-average number of shares outstanding, basic and diluted |
|
57,825,636 |
|
|
|
50,294,787 |
|
|
|
57,772,602 |
|
|
|
50,271,373 |
|
GAAP to non-GAAP reconciliations (Unaudited) (In thousands) |
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A reconciliation between net loss on a GAAP basis and on a non-GAAP basis is as follows: | |||||||||||||||
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Three Months Ended
|
|
Six Months Ended
|
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|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
GAAP net loss, as reported |
$ |
(28,536 |
) |
|
$ |
(33,553 |
) |
|
$ |
(58,175 |
) |
|
$ |
(86,915 |
) |
Adjustments: |
|
|
|
|
|
|
|
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Non-cash operating lease costs |
|
(25 |
) |
|
|
248 |
|
|
|
(49 |
) |
|
|
496 |
|
Accretion of Convertible Senior Notes and Term Loan |
|
226 |
|
|
|
2,176 |
|
|
|
449 |
|
|
|
4,804 |
|
Loss on early extinguishment of Term Loan |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
6,124 |
|
Stock-based compensation |
|
7,071 |
|
|
|
6,609 |
|
|
|
13,595 |
|
|
|
12,651 |
|
Changes in compound derivative liability |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(202 |
) |
Restructuring costs |
|
— |
|
|
|
(113 |
) |
|
|
— |
|
|
|
107 |
|
Total adjustments |
|
7,272 |
|
|
|
8,920 |
|
|
|
13,995 |
|
|
|
23,980 |
|
Non-GAAP net loss |
$ |
(21,264 |
) |
|
$ |
(24,633 |
) |
|
$ |
(44,180 |
) |
|
$ |
(62,935 |
) |
Use of Non-GAAP Financial Measures
“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 Convertible Senior Notes and Term Loan, (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 the GAAP to Non-GAAP net loss. Non-GAAP financial measures used by
View source version on businesswire.com: https://www.businesswire.com/news/home/20220808005698/en/
Senior Vice President of
Investor Relations and Communications
IR@Tricida.com
Source:
FAQ
What were Tricida's financial results for Q2 2022?
What is the current financial position of Tricida?
When will Tricida announce the results of the VALOR-CKD trial?
How did Tricida's revenue change compared to last year?