Webcast Today at 8:00 am Eastern Time
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the
development and commercialization of its drug candidate, TRC101
(veverimer), a non-absorbed, orally-administered polymer designed to
treat metabolic acidosis in patients with chronic kidney disease (CKD),
announced today financial results for the three months and full year
ended December 31, 2018 and provided an update on key initiatives.
Recent Highlights
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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
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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 in July 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
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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 Gerrit Klaerner, Ph.D., Tricida’s Chief Executive
Officer and President. “We remain committed to submitting our NDA under
the Accelerated Approval Program in the second half of 2019 and look
forward to the results of our VALOR-CKD confirmatory postmarketing
trial.”
Financial Results for the Quarter and Year Ended December 31, 2018
Research and development expense was $22.7 million and $17.8 million for
the three months ended December 31, 2018 and 2017, respectively, and
$85.6 million and $35.9 million for the years ended December 31, 2018
and 2017, respectively. The increases in research and development
expense in the three-month and full year periods of 2018 compared to the
prior periods were primarily due to increased activities in connection
with our TRC101 clinical development program, including increased drug
substance manufacturing, as well as increased personnel and related
costs.
General and administrative expense was $6.1 million and $2.9 million for
the three months ended December 31, 2018 and 2017, respectively, and
$18.0 million and $11.2 million for the years ended December 31, 2018
and 2017, respectively. The increases in general and administrative
expense in the three-month and full year periods of 2018 compared to the
prior period were primarily due to increased administrative costs
supporting the increased activities in connection with our TRC101
clinical development program, increased headcount and higher
professional service fees.
Net loss was $27.8 million (non-GAAP net loss of $25.3 million) and
$20.6 million (non-GAAP net loss of $20.2 million) for the three months
ended December 31, 2018 and 2017, respectively, and $102.8 million
(non-GAAP net loss of $96.5 million) and $41.3 million (non-GAAP net
loss of $46.0 million) for the years ended December 31, 2018 and 2017,
respectively. Net loss per basic and diluted share was $0.66 and $9.05
for the three months ended December 31, 2018 and 2017, respectively, and
$4.64 and $19.32 for the years ended December 31, 2018, and 2017,
respectively.
As of December 31, 2018, cash, cash equivalents and investments were
$243.4 million.
Financial Guidance
Tricida estimates a cash expenditure of $135 to $145 million in
2019. Based on its current operating plan, Tricida expects that its cash
and investments as of December 31, 2018 and its anticipated borrowing
capacity under its Hercules debt facility will enable the Company to
fund its anticipated operating expenses and capital expenditure
requirements into 2021.
Today’s Conference Call and Webcast
Tricida will host a conference call today at 8:00 am Eastern Time to
discuss its financial results and business progress. Please access the
Tricida Conference Call as follows:
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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 | |||
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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 Tricida
Tricida, Inc. is a pharmaceutical company focused on the development and
commercialization of its drug candidate, TRC101, a non-absorbed,
orally-administered polymer designed to treat metabolic acidosis in
patients with chronic kidney disease (CKD). Metabolic acidosis is a
condition commonly caused by CKD that is believed to accelerate the
progression of kidney deterioration. It is estimated to pose a health
risk to approximately three million patients with CKD in the United
States. Tricida has successfully completed all of the clinical trials
that it planned to complete prior to submission of an NDA to the U.S.
Food and Drug Administration (FDA). Tricida plans to submit an NDA in
the second half of 2019, seeking approval of TRC101 through the FDA’s
Accelerated Approval Program.
For more information about Tricida, please visit www.Tricida.com.
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 FDA’s Accelerated Approval
Program. Forward-looking statements involve known and unknown risks,
uncertainties, assumptions and other factors that may cause our actual
results, performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by the
forward-looking statements. These risks and uncertainties include, among
others, that we may not be able to achieve upcoming milestones, the
cost, timing and results of clinical trials and other studies; that many
drug candidates that have completed Phase 3 trials do not become
approved drugs on a timely or cost effective basis, or at all; there can
be no assurance that the FDA would approve an NDA under the Accelerated
Approval Program, or at all, and even if approval for a drug is
obtained, there can be no assurance that it will be adopted in the
market or accepted as a benefit to patients and healthcare providers;
possible safety and efficacy concerns; and that we completely rely on
third-party suppliers to manufacture our clinical drug supply. The
forward-looking statements contained in this press release reflect
Tricida’s current views with respect to future events, and Tricida does
not undertake and specifically disclaims any obligation to update any
forward-looking statements.
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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 | ||||
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Liabilities, convertible preferred stock and stockholders’ equity (deficit) |
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| 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 | ) | |||||
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Total liabilities, convertible preferred stock and stockholders’ equity (deficit) |
$ | 247,849 | $ | 70,574 | ||||
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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: | ||||||||||||||||
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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 | ||||||||||||
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Tricida, Inc. |
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GAAP to non-GAAP reconciliations |
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A reconciliation between net loss on a GAAP basis and on a |
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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 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 income, 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 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 Tricida may be calculated differently from,
and therefore may not be comparable to, non-GAAP measures used by other
companies.
Contacts
Jackie Cossmon, IRC
Tricida, Inc.
Vice President of Investor
Relations and Communications
IR@Tricida.com