Webcast Today at 4:30 pm Eastern Time
Tricida, Inc. (Nasdaq: TCDA) announced today financial results
for the three and six months ended June 30, 2022 and provided an
update on key initiatives.
Business Update
- Tricida announced in May 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 in October 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 to 40% 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 in October 2022.
“We are really proud of our Tricida team, along with our partner
CROs, who are doing a fabulous job ensuring an orderly completion
of the VALOR-CKD trial at almost 200 sites in over 30 countries to
enable top-line data in October,” said Gerrit Klaerner, Ph.D.,
Tricida’s Chief Executive Officer and President.
Financial Results for the Three and Six Months Ended June 30,
2022
Research and development expense was $16.9 million and $19.8
million for the three months ended June 30, 2022 and 2021,
respectively. The decrease in research and development expense for
the three months ended June 30, 2022 compared to the prior year was
primarily due to a decrease in clinical development costs related
to the VALOR-CKD trial following the administrative stop announced
in May 2022. Research and development expense was $35.4 million and
$52.0 million for the six months ended June 30, 2022 and 2021,
respectively. The decrease in research and development expense for
the six months ended June 30, 2022 compared to the prior year was
primarily due to a decrease in clinical development costs related
to the VALOR-CKD trial following the administrative stop announced
in May 2022.
General and administrative expense was $9.8 million and $9.6
million for the three months ended June 30, 2022 and 2021,
respectively. The increase in general and administrative expense
for the three months ended June 30, 2022 compared to the prior year
was primarily due to higher stock-based compensation expense.
General and administrative expense was $19.0 million and $19.4
million for the six months ended June 30, 2022 and 2021,
respectively. The decrease in general and administrative expense
for the six months ended June 30, 2022 compared to the prior year
was primarily due to lower legal and finance costs.
Net loss was $28.5 million (non-GAAP net loss of $21.3 million)
and $33.6 million (non-GAAP net loss of $24.6 million) for the
three months ended June 30, 2022 and 2021, respectively, and $58.2
million (non-GAAP net loss of $44.2 million) and $86.9 million
(non-GAAP net loss of $62.9 million) for the six months ended June
30, 2022 and 2021, respectively. Net loss per basic and diluted
share was $0.49 and $0.67 for the three months ended June 30, 2022
and 2021, respectively, and $1.01 and $1.73 for the six months
ended June 30, 2022 and 2021, respectively.
As of June 30, 2022, cash, cash equivalents and investments were
$98.7 million.
Financial Guidance
Tricida currently has the financial resources to fund its
planned operations into early in the second quarter of 2023, which
is approximately six months from the anticipated announcement of
its top-line results for the VALOR-CKD trial.
Tricida Conference Call Information
Tricida will host its Second 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 Second Quarter
Financial Results Conference Call
Monday, August 8, 2022
4:30 pm Eastern Time
Webcast:
IR.Tricida.com
Dial In:
(800) 715-9871
International:
(646) 307-1963
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.
About Tricida
Tricida, Inc. is a pharmaceutical company focused on the
development and commercialization of its investigational drug
candidate, veverimer, a non-absorbed, orally-administered polymer
designed to slow CKD progression in patients with metabolic
acidosis and 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. 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 4.3 million
patients with CKD in the United States. There are currently no
therapies approved by the FDA to slow progression of kidney disease
by correcting chronic metabolic acidosis in patients with CKD.
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 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 Ukraine; and risks associated with the Company’s business
prospects, financial results and business 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 (the “SEC”), including the
Company’s most recent Annual Report filed on Form 10-K and the
subsequently filed Quarterly Report(s) on Form 10-Q. 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.
Tricida, Inc.
Condensed Balance
Sheets
(Unaudited)
(In thousands)
June 30, 2022
December 31,
2021
Assets
Current assets:
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
Liabilities and stockholders’ equity
(deficit)
Current liabilities:
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
Convertible Senior Notes, net
195,119
127,512
Non-current operating lease
liabilities
10,346
11,296
Total liabilities
225,512
168,288
Stockholders’ equity (deficit):
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
Tricida, Inc.
Condensed Statements of
Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share
and per share amounts)
Three Months Ended
June 30,
Six Months Ended
June 30,
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):
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
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 Ended
June 30,
Six Months Ended
June 30,
2022
2021
2022
2021
GAAP net loss, as reported
$
(28,536
)
$
(33,553
)
$
(58,175
)
$
(86,915
)
Adjustments:
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
Tricida supplements its 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. The Company believes that the disclosure
of these non-GAAP financial measures provides investors with
additional information that reflects the amounts and financial
basis upon which management assesses and operates the Company’s
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 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
Tricida may be calculated differently from, and therefore may not
be comparable to, non-GAAP measures used by other companies.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220808005698/en/
Jackie Cossmon, IRC Tricida, Inc. Senior Vice President of
Investor Relations and Communications IR@Tricida.com
Tricida (NASDAQ:TCDA)
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