Tricida Announces Fourth Quarter and Full-Year 2018 Financial Results
Webcast Today at
Recent Highlights
- Announced today, initial topline data analyses of the TRCA-301E trial, a placebo-controlled, blinded, 40-week extension trial, revealed positive results. The trial met its primary and all secondary endpoints.
-
Announced today, an amendment to its existing debt facility with
Hercules Capital, Inc. , increasing the total amount available under the debt facility to up to$200 million and extending the maturity of the debt facility. -
The Lancet published results from the TRCA-301 Phase 3 clinical trial
in
March 2019 .
2018 Highlights
- Initiated enrollment in the VALOR-CKD confirmatory postmarketing clinical trial in the fourth quarter of 2018.
-
Completed an initial public offering (IPO) for total gross proceeds of
approximately
$255.6 million inJuly 2018 . -
Reported top-line results from the TRCA-301 Phase 3 clinical trial,
which met both its primary and secondary endpoints in
June 2018 .
2019 Projected Milestones
- Availability of New Drug Application (NDA)-enabling 12-month registration stability data for TRC101 in mid-2019.
- Submission of an NDA in the second half of 2019, seeking approval of TRC101 through the U.S. Food and Drug Administration’s (FDA’s) Accelerated Approval Program.
“Among our recent and 2018 highlights, the topline clinical data which
we reported today truly stands out. We did not anticipate that we would
observe evidence of clinical benefit beyond the increase in blood
bicarbonate in patients treated with TRC101 until the read out of the
results of our postmarketing trial, VALOR-CKD, in the 2022 to 2023
timeframe,” said
Financial Results for the Quarter and Year Ended
Research and development expense was
General and administrative expense was
Net loss was
As of
Financial Guidance
Today’s Conference Call and Webcast
Tricida TRCA-301E Clinical Trial Results and |
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Financial Results Conference Call |
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8:00 am Eastern Time Today |
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Website: |
IR.Tricida.com |
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Dial-in: |
(877) 377-5478 |
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International: | (629) 228-0740 | |||
Conference ID: |
1756243 |
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A replay of the webcast will be available on the Investor Relations page of 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
For more information about
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements, including for
example, all of the statements under the headings “Financial Guidance”
and “2019 Projected Milestones” and other statements about our ability
to submit an NDA for TRC101 under the
Tricida, Inc. |
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Condensed Balance Sheets |
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(Unaudited) |
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(In thousands) |
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December 31, 2018 |
December 31, 2017 |
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Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 37,172 | $ | 9,774 | ||||
Short-term investments | 203,906 | 57,740 | ||||||
Prepaid expenses and other current assets | 3,269 | 1,910 | ||||||
Total current assets | 244,347 | 69,424 | ||||||
Long-term investments | 2,287 | — | ||||||
Property and equipment, net | 1,215 | 1,150 | ||||||
Total assets | $ | 247,849 | $ | 70,574 | ||||
Liabilities, convertible preferred stock and stockholders’ equity (deficit) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 8,460 | $ | 3,861 | ||||
Accrued expenses and other current liabilities | 6,344 | 7,361 | ||||||
Total current liabilities | 14,804 | 11,222 | ||||||
Term loan | 38,071 | — | ||||||
Other long-term liabilities | 449 | 323 | ||||||
Total liabilities | 53,324 | 11,545 | ||||||
Convertible preferred stock | — | 147,070 | ||||||
Stockholders’ equity (deficit): | ||||||||
Common stock | 42 | 2 | ||||||
Additional paid-in capital | 386,830 | 1,356 | ||||||
Accumulated other comprehensive loss | (153 | ) | (13 | ) | ||||
Accumulated deficit | (192,194 | ) | (89,386 | ) | ||||
Total stockholders’ equity (deficit) | 194,525 | (88,041 | ) | |||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ | 247,849 | $ | 70,574 | ||||
Tricida, Inc. |
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Condensed Statements of Operations and Comprehensive Loss |
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(Unaudited) |
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(In thousands, except share and per share amounts) |
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Three Months Ended December 31, |
Years Ended December 31, |
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2018 | 2017 | 2018 | 2017 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 22,697 | $ | 17,770 | $ | 85,594 | $ | 35,906 | ||||||||
General and administrative | 6,113 | 2,887 | 18,001 | 11,216 | ||||||||||||
Total operating expenses | 28,810 | 20,657 | 103,595 | 47,122 | ||||||||||||
Loss from operations | (28,810 | ) | (20,657 | ) | (103,595 | ) | (47,122 | ) | ||||||||
Change in fair value—preferred stock tranche obligation | — | — | — | 5,649 | ||||||||||||
Other income (expense), net | 1,937 | 107 | 3,924 | 183 | ||||||||||||
Interest expense | (971 | ) | — | (3,137 | ) | — | ||||||||||
Net loss | (27,844 | ) | (20,550 | ) | (102,808 | ) | (41,290 | ) | ||||||||
Other comprehensive loss: | ||||||||||||||||
Net unrealized gain (loss) on available-for-sale securities, net of tax | (113 | ) | (11 | ) | (140 | ) | (13 | ) | ||||||||
Comprehensive loss | $ | (27,957 | ) | $ | (20,561 | ) | $ | (102,948 | ) | $ | (41,303 | ) | ||||
Net loss per share, basic and diluted | $ | (0.66 | ) | $ | (9.05 | ) | $ | (4.64 | ) | $ | (19.32 | ) | ||||
Weighted-average number of shares outstanding, basic and diluted | 42,081,869 | 2,270,435 | 22,146,192 | 2,137,690 | ||||||||||||
Tricida, Inc. |
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GAAP to non-GAAP reconciliations |
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(Unaudited) |
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(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 December 31, |
Years Ended December 31, |
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2018 | 2017 | 2018 | 2017 | |||||||||||||
GAAP net loss, as reported | $ | (27,844 | ) | $ | (20,550 | ) | $ | (102,808 | ) | $ | (41,290 | ) | ||||
Adjustments: | ||||||||||||||||
Non-cash stock-based compensation expense | 2,123 | 280 | 5,152 | 876 | ||||||||||||
Non-cash term loan discount and issuance costs | 414 | — | 1,316 | — | ||||||||||||
Mark-to-market adjustment on financial instruments | 50 | 54 | (188 | ) | (5,581 | ) | ||||||||||
Total adjustments | 2,587 | 334 | 6,280 | (4,705 | ) | |||||||||||
Non-GAAP net loss | $ | (25,257 | ) | $ | (20,216 | ) | $ | (96,528 | ) | $ | (45,995 | ) | ||||
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 income“ is not based on any standardized methodology
prescribed by GAAP and represent GAAP net income adjusted to exclude (1)
stock-based compensation expense, (2) non-cash interest expense related
to Tricida’s term loan discount and issuance costs and (3) mark-to
market adjustments related to financial instruments held (which include
preferred stock tranche obligations, warrants and derivatives) within
our reconciliation of our GAAP to Non-GAAP net income. Non-GAAP
financial measures used by
View source version on businesswire.com: https://www.businesswire.com/news/home/20190328005287/en/
Source:
Jackie Cossmon, IRC
Tricida, Inc.
Vice President of Investor
Relations and Communications
IR@Tricida.com