Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused
on the development and commercialization of its investigational
drug candidate, veverimer, a non-absorbed, orally-administered
polymer designed to treat metabolic acidosis and slow CKD
progression in patients with chronic kidney disease (CKD),
announced today financial results for the three months ended March
31, 2021 and provided an update on key initiatives.
Recent Events
- Tricida continues to execute on
recruitment and conduct of the VALOR-CKD renal outcomes trial. As
of May 4, 2021, the VALOR-CKD renal outcomes trial has randomized
1,440 of 1,600 subjects with an average treatment duration of
approximately 15 months and has accrued 95 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).
- Tricida sponsored several
presentations at the National Kidney Foundation Spring Clinical
Meeting 2021 that occurred April 6 to 10, 2021, including analyses
of: 1) the association between metabolic acidosis and accelerated
kidney decline, 2) the association in kidney transplant recipients
between metabolic acidosis and graft failure and 3) the association
in kidney transplant recipients between metabolic acidosis and a
higher risk of death. In addition, Tricida presented in vitro data
showing that veverimer does not bind to, or affect the ion binding
properties of, other non-absorbed binder drugs that are prescribed
to patients with CKD, such as RENVELA, VELTASSA, LOKELMA and
KAYEXALATE.
- Tricida previously announced that
it received an Appeal Denied Letter (ADL) from the Office of New
Drugs (OND) of the U.S. Food and Drug Administration (FDA) in
response to its Formal Dispute Resolution Request (FDRR). Tricida
intends to continue execution of the ongoing VALOR-CKD renal
outcomes trial and believes that the optimal path forward for the
potential approval of veverimer is to provide additional data to
the FDA from the VALOR-CKD renal outcomes trial.
Upcoming Milestones
- Anticipate the first VALOR-CKD
renal outcomes trial interim analysis for early stopping for
efficacy in the second half of 2021, when 150 patients with DD40
events are expected to have accrued. 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.
- Anticipate the second VALOR-CKD
renal outcomes trial interim analysis for early stopping for
efficacy in mid-2022, when 250 patients with DD40 events are
expected to have accrued. 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.
“Our VALOR-CKD trial is our key focus this year,” said Gerrit
Klaerner, Ph.D., Tricida’s Chief Executive Officer and President.
“The timing of accrual of primary endpoint events in the VALOR-CKD
trial is an important measure moving forward as it will impact our
options for next steps in veverimer’s development given our current
financial resources.”
Financial Results for the Three Months Ended March 31,
2021
Research and development expense was $32.2 million and $49.4
million for the three months ended March 31, 2021 and 2020,
respectively. The decrease in research and development expense for
the three months ended March 31, 2021 compared to the prior year
was primarily due to decreased activities in connection with our
veverimer clinical development program related to manufacturing
process optimization and the manufacturing of drug substance and
lower personnel costs.
General and administrative expense was $9.9 million and $23.5
million for the three months ended March 31, 2021 and 2020,
respectively. The decrease in general and administrative expense
for the three months ended March 31, 2021 compared to the prior
year was primarily due to decreased administrative activities in
connection with our veverimer clinical development program,
including pre-commercialization, medical affairs and personnel
costs.
Net loss was $53.4 million (non-GAAP net loss of $38.3 million)
and $74.1 million (non-GAAP net loss of $63.8 million) for the
three months ended March 31, 2021 and 2020, respectively. Net loss
per basic and diluted share was $1.06 and $1.49 for the three
months ended March 31, 2021 and 2020, respectively.
As of March 31, 2021, cash, cash equivalents and investments
were $217.7 million.
Financial Guidance
Tricida believes it has financial resources to fund its planned
operations into late 2022. Based on the current rate of primary
endpoint events in the VALOR-CKD renal outcomes trial, the first
and second interim analyses for early stopping of the trial are
expected to occur within the time frame of our existing
capital.
Tricida Conference Call Information
Tricida will host its First Quarter Financial Results and
Business Update Conference Call and webcast today at 4:30 pm
Eastern Time. The webcast or conference call may be accessed as
follows:
|
Tricida
Conference Call |
|
|
Thursday,
May 6, 2021 |
|
|
4:30 pm
Eastern Time |
|
|
Webcast: |
IR.Tricida.com |
|
|
Dial-In: |
(877) 377-5478 |
|
|
International: |
(629)
288-0740 |
|
|
Conference ID: |
9047649 |
|
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.
About Tricida
Tricida, Inc. is a pharmaceutical company focused on the
development and commercialization of its investigational drug
candidate, veverimer (also known as TRC101), a non-absorbed,
orally-administered polymer designed to treat metabolic acidosis
and slow CKD progression in patients with CKD. Tricida is currently
conducting a renal outcomes clinical trial, VALOR-CKD, to determine
if veverimer slows CKD progression in patients with metabolic
acidosis associated with CKD. There are no FDA-approved treatments
for chronic metabolic acidosis. 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.
For more information about Tricida, please
visit Tricida.com.
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 Milestones” and
“Financial Guidance” and other statements, including the Company’s
plans and expectations regarding event accrual rates for the
VALOR-CKD renal outcomes 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, 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 our its key suppliers and vendors; the
Company’s financial projections and cost estimates; risks
associated with the COVID-19 pandemic; and 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
Securities and Exchange Commission (SEC), including the Company’s
most recent Annual Report filed on Form 10-K. You should not place
undue reliance on these forward-looking statements, which speak
only as of the date of this press release. Except as required by
applicable law, the Company does not intend to update any of the
forward-looking statements to conform these statements to actual
results, later events or circumstances or to reflect the occurrence
of unanticipated events.
(Financial Tables to Follow)Tricida,
Inc.
Condensed Balance
Sheets(Unaudited)(In
thousands)
|
March 31,2021 |
|
December 31,2020 |
Assets |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
40,510 |
|
|
|
$ |
137,857 |
|
|
Short-term investments |
177,221 |
|
|
|
171,670 |
|
|
Prepaid expenses and other current assets |
2,989 |
|
|
|
4,488 |
|
|
Total current assets |
220,720 |
|
|
|
314,015 |
|
|
Long-term investments |
— |
|
|
|
22,757 |
|
|
Property and equipment, net |
1,053 |
|
|
|
1,112 |
|
|
Operating lease right-of-use
assets |
13,395 |
|
|
|
13,801 |
|
|
Total assets |
$ |
235,168 |
|
|
|
$ |
351,685 |
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
5,321 |
|
|
|
$ |
3,508 |
|
|
Current operating lease liabilities |
2,341 |
|
|
|
2,079 |
|
|
Accrued expenses and other current liabilities |
32,543 |
|
|
|
28,671 |
|
|
Total current liabilities |
40,205 |
|
|
|
34,258 |
|
|
|
|
|
|
Term Loan, net |
— |
|
|
|
76,638 |
|
|
Convertible Senior Notes,
net |
120,775 |
|
|
|
118,670 |
|
|
Non-current operating lease
liabilities |
12,627 |
|
|
|
13,046 |
|
|
Other long-term liabilities |
— |
|
|
|
202 |
|
|
Total liabilities |
173,607 |
|
|
|
242,814 |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock |
— |
|
|
|
— |
|
|
Common stock |
50 |
|
|
|
50 |
|
|
Additional paid-in capital |
748,712 |
|
|
|
742,555 |
|
|
Accumulated other comprehensive income (loss) |
(41 |
) |
|
|
64 |
|
|
Accumulated deficit |
(687,160 |
) |
|
|
(633,798 |
) |
|
Total stockholders’ equity |
61,561 |
|
|
|
108,871 |
|
|
Total liabilities and stockholders’ equity |
$ |
235,168 |
|
|
|
$ |
351,685 |
|
|
Tricida, Inc.
Condensed Statements of Operations and
Comprehensive Loss(Unaudited)(In
thousands, except share and per share amounts)
|
Three Months EndedMarch 31, |
|
2021 |
|
2020 |
Operating expenses: |
|
|
|
Research and development |
$ |
32,175 |
|
|
|
$ |
49,381 |
|
|
General and administrative |
9,895 |
|
|
|
23,526 |
|
|
Total operating expenses |
42,070 |
|
|
|
72,907 |
|
|
Loss from operations |
(42,070 |
) |
|
|
(72,907 |
) |
|
Other income (expense),
net |
445 |
|
|
|
813 |
|
|
Interest expense |
(5,613 |
) |
|
|
(2,020 |
) |
|
Loss on early extinguishment
of Term Loan |
(6,124 |
) |
|
|
— |
|
|
Net loss |
(53,362 |
) |
|
|
(74,114 |
) |
|
Other comprehensive income (loss): |
|
|
|
Net unrealized gain (loss) on available-for-sale investments, net
of tax |
(105 |
) |
|
|
(232 |
) |
|
Total comprehensive loss |
$ |
(53,467 |
) |
|
|
$ |
(74,346 |
) |
|
Net loss per share, basic and
diluted |
$ |
(1.06 |
) |
|
|
$ |
(1.49 |
) |
|
Weighted-average number of
shares outstanding, basic and diluted |
50,247,698 |
|
|
|
49,841,407 |
|
|
Tricida, Inc.
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 EndedMarch 31, |
|
2021 |
|
2020 |
GAAP net loss, as reported |
$ |
(53,362 |
) |
|
|
$ |
(74,114 |
) |
|
Adjustments: |
|
|
|
Non-cash operating lease costs |
248 |
|
|
|
320 |
|
|
Accretion of Term Loan and Convertible Senior Notes |
2,628 |
|
|
|
751 |
|
|
Loss on early extinguishment of Term Loan |
6,124 |
|
|
|
— |
|
|
Stock-based compensation |
6,042 |
|
|
|
8,374 |
|
|
Changes in fair value of compound derivative liability |
(202 |
) |
|
|
846 |
|
|
Restructuring costs |
220 |
|
|
|
— |
|
|
Total adjustments |
15,060 |
|
|
|
10,291 |
|
|
Non-GAAP net loss |
$ |
(38,302 |
) |
|
|
$ |
(63,823 |
) |
|
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 loss 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 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 (cash and non-cash), in reconciling of our GAAP to Non-GAAP
net loss. 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.
Contact:Jackie Cossmon, IRCTricida, Inc.Senior Vice President of
Investor Relations and CommunicationsIR@Tricida.com
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