Tricida, Inc. (Nasdaq: TCDA) announced today financial results
for the three and nine months ended September 30, 2022 and provided
an update on key initiatives.
Business Update
- Tricida announced in October the top-line results from its
VALOR-CKD renal outcomes clinical trial, designed to evaluate
veverimer’s ability to slow CKD progression in patients with
metabolic acidosis and chronic kidney disease (CKD). The VALOR-CKD
trial did not meet its primary endpoint, which was defined as the
time to the first occurrence of any event in the composite endpoint
of renal death, end-stage renal disease (ESRD), or a confirmed
greater than or equal to 40% reduction in estimated glomerular
filtration rate (eGFR), also known as DD40. The overall safety
profile of veverimer observed in the trial was consistent with that
expected for the general population of patients with Stage 3 to 5
CKD. Data from the trial were also presented at the High Impact
Clinical Studies session at the ASN Kidney Week 2022
conference.
- Tricida announced in November that the Board of Directors has
authorized Tricida to conduct a thorough review of strategic
options in order to maximize value to its stakeholders. Tricida has
engaged Stifel and its wholly owned affiliate, Miller Buckfire, to
serve as investment banking advisors and SierraConstellation
Partners LLC to serve as a financial advisor.
- Tricida has put into place a reduction in force plan which
includes an approximate 57% reduction in workforce. The Company
estimates aggregate costs of approximately $2.0 million, recorded
primarily in November of 2022, related to one-time termination
severance payments and other employee-related costs that will be
paid during the fourth quarter of 2022 and the first quarter of
2023.
Financial Results for the Three and Nine Months Ended
September 30, 2022
Research and development expense was $19.9 million and $26.6
million for the three months ended September 30, 2022 and 2021,
respectively. The decrease in research and development expense for
the three months ended September 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, a decrease in personnel and related costs
related to lower bonus expense and a decrease in stock-based
compensation expense. Research and development expense was $55.3
million and $78.6 million for the nine months ended September 30,
2022 and 2021, respectively. The decrease in research and
development expense for the nine months ended September 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, a decrease in
personnel and related costs related to lower bonus expense and a
decrease in stock-based compensation expense.
General and administrative expense was $4.1 million and $9.1
million for the three months ended September 30, 2022 and 2021,
respectively. The decrease in general and administrative expense
for the three months ended September 30, 2022 compared to the prior
year was primarily due to a decrease in personnel and related costs
related to lower bonus expense and a decrease in stock-based
compensation expense. General and administrative expense was $23.1
million and $28.5 million for the nine months ended September 30,
2022 and 2021, respectively. The decrease in general and
administrative expense for the nine months ended September 30, 2022
compared to the prior year was primarily due to a decrease in
personnel and related costs related to lower bonus expense and a
decrease in stock-based compensation expense.
Net loss was $25.8 million (non-GAAP net loss of $24.8 million)
and $39.7 million (non-GAAP net loss of $30.7 million) for the
three months ended September 30, 2022 and 2021, respectively, and
$83.9 million (non-GAAP net loss of $69.0 million) and $126.6
million (non-GAAP net loss of $93.6 million) for the nine months
ended September 30, 2022 and 2021, respectively. Net loss per basic
and diluted share was $0.44 and $0.79 for the three months ended
September 30, 2022 and 2021, respectively, and $1.45 and $2.52 for
the nine months ended September 30, 2022 and 2021,
respectively.
As of September 30, 2022, cash, cash equivalents and investments
were $80.2 million.
About Tricida
Tricida, Inc. is a pharmaceutical company focused on its
investigational drug candidate, veverimer, a non-absorbed,
orally-administered polymer designed to slow CKD progression in
patients with metabolic acidosis and 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 other
statements, including the Company’s plans to conduct a thorough
review of strategic options. 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 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; 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)
September 30,
2022
December 31,
2021
Assets
Current assets:
Cash and cash equivalents
$
17,744
$
21,113
Short-term investments
62,475
119,419
Prepaid expenses and other current
assets
2,265
5,004
Total current assets
82,484
145,536
Long-term investments
__—
10,043
Property and equipment, net
541
769
Operating lease right-of-use assets
10,854
12,158
Total assets
$
93,879
$
168,506
Liabilities and stockholders’ equity
(deficit)
Current liabilities:
Accounts payable
$
4,395
$
10,023
Current operating lease liabilities
2,797
2,736
Accrued expenses and other current
liabilities
9,735
16,721
Total current liabilities
16,927
29,480
Convertible Senior Notes, net
195,347
127,512
Non-current operating lease
liabilities
9,851
11,296
Other long-term liabilities
7,852
—
Total liabilities
229,977
168,288
Stockholders’ equity (deficit):
Preferred stock
—
—
Common stock
56
55
Additional paid-in capital
746,234
810,618
Accumulated other comprehensive income
(loss)
(428
)
(91
)
Accumulated deficit
(881,960
)
(810,364
)
Total stockholders’ equity (deficit)
(136,098
)
218
Total liabilities and stockholders’ equity
(deficit)
$
93,879
$
168,506
Tricida, Inc.
Condensed Statements of
Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share
and per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Operating expenses:
Research and development
$
19,935
$
26,635
$
55,298
$
78,591
General and administrative
4,125
9,052
23,119
28,497
Total operating expenses
24,060
35,687
78,417
107,088
Loss from operations
(24,060
)
(35,687
)
(78,417
)
(107,088
)
Other income (expense), net
277
6
408
155
Interest expense
(1,978
)
(3,994
)
(5,927
)
(13,533
)
Loss on early extinguishment of 2018 Term
Loan
—
—
—
(6,124
)
Net loss
(25,761
)
(39,675
)
(83,936
)
(126,590
)
Other comprehensive income (loss):
Net unrealized gain (loss) on
available-for-sale investments, net of tax
47
(15
)
(337
)
(141
)
Total comprehensive loss
$
(25,714
)
$
(39,690
)
$
(84,273
)
$
(126,731
)
Net loss per share, basic and diluted
$
(0.44
)
$
(0.79
)
$
(1.45
)
$
(2.52
)
Weighted-average number of shares
outstanding, basic and diluted
58,015,939
50,434,879
57,854,606
50,326,474
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
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
GAAP net loss, as reported
$
(25,761
)
$
(39,675
)
$
(83,936
)
$
(126,590
)
Adjustments:
Non-cash operating lease costs
(31
)
78
(80
)
574
Accretion of Convertible Senior Notes and
2018 Term Loan
228
2,243
677
7,047
Loss on early extinguishment of 2018 Term
Loan
—
—
—
6,124
Stock-based compensation
787
6,649
14,382
19,300
Changes in compound derivative
liability
—
—
—
(202
)
Restructuring costs
—
—
—
107
Total adjustments
984
8,970
14,979
32,950
Non-GAAP net loss
$
(24,777
)
$
(30,705
)
$
(68,957
)
$
(93,640
)
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 2018 Term Loan, (3) loss on early extinguishment
of 2018 Term Loan, (4) stock-based compensation, (5) changes in
compound derivative liability and (6) restructuring costs, in
reconciling of 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/20221114005800/en/
Tricida, Inc. Investor Relations and Communications
IR@Tricida.com
Tricida (NASDAQ:TCDA)
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