Tricida, Inc. (Nasdaq: TCDA) announced today financial results
for the three months and year ended December 31, 2021 and provided
an update on key initiatives.
Business Update
- Tricida continued to execute on the
conduct of the VALOR-CKD renal outcomes clinical trial. Enrollment
of patients in the VALOR-CKD trial was completed at the end of 2021
with 1,480 subjects randomized. As of March 28, 2022, randomized
subjects had an average treatment duration of approximately 24
months, and the trial had accrued 217 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).
Upcoming Milestone
- Tricida previously reported that based on its financial runway
it intends to stop the VALOR-CKD trial early for administrative
reasons in the second quarter of 2022, with continued accrual of
primary endpoint events into the third quarter of 2022. The
reporting of top-line results from the VALOR-CKD trial is
anticipated to occur early in the fourth quarter of 2022, which
would allow for approximately six months of financial runway
following the announcement.
“Against the backdrop of a pandemic and a war, we have managed
to remain on track with our projections for primary endpoint events
in the VALOR-CKD trial,” said Gerrit Klaerner, Ph.D., Tricida’s
Chief Executive Officer and President. “We are very encouraged by
our progress and continue to believe that the VALOR-CKD trial will
provide interpretable data to evaluate how treatment with veverimer
impacts slowing of CKD progression in patients with metabolic
acidosis and CKD.”
Financial Results for the Three Months and Year Ended
December 31, 2021
Research and development expense was $36.8 million and $27.3
million for the three months ended December 31, 2021 and 2020,
respectively, and $115.4 million and $148.4 million for the years
ended December 31, 2021 and 2020, respectively. The increase in
research and development expense for the three months ended
December 31, 2021 compared to the prior year was primarily due to
increased activities in connection with our veverimer clinical
development program related to manufacturing process optimization
and the manufacturing of drug substance. The decrease in research
and development expense for the year ended December 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 $9.1 million and $21.8
million for the three months ended December 31, 2021 and 2020,
respectively, and $37.6 million and $103.0 million for the years
ended December 31, 2021 and 2020, respectively. The decrease in
general and administrative expense for the three months ended
December 31, 2021 compared to the prior year was primarily due to
restructuring costs, including one-time termination severance
payments and contract termination costs, incurred in the prior year
and decreased administrative activities in connection with our
veverimer clinical development program, including
pre-commercialization and medical affairs. The decrease in general
and administrative expense for the year ended December 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 and restructuring costs, including
one-time termination severance payments and contract termination
costs, incurred in the prior year.
Net loss was $50.0 million (non-GAAP net loss of $41.1 million)
and $54.8 million (non-GAAP net loss of $37.4 million) for the
three months ended December 31, 2021 and 2020, respectively, and
$176.6 million (non-GAAP net loss of $134.7 million) and $264.8
million (non-GAAP net loss of $214.4 million) for the years ended
December 31, 2021 and 2020, respectively. Net loss per basic and
diluted share was $0.92 and $1.09 for the three months ended
December 31, 2021 and 2020, respectively, and $3.44 and $5.29 for
the years ended December 31, 2021 and 2020, respectively.
As of December 31, 2021, cash, cash equivalents and investments
were $150.6 million.
Financial Guidance
Tricida currently has the financial resources to fund its
planned operations into early in the second quarter of 2023, which
is anticipated to be approximately six months from the announcement
of its top-line results for the VALOR-CKD trial.
Tricida Conference Call Information
Tricida will host its Fourth 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 Fourth Quarter Financial Results Conference
Call |
Tuesday, March 29, 2022 |
4:30 pm Eastern Time |
|
|
|
|
Webcast: |
IR.Tricida.com |
|
Dial-in: |
(877)
377-5478 |
|
International: |
(629) 228-0740 |
|
Conference
ID: |
1932119 |
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 heading “Upcoming Milestone” and other
statements, including the Company’s plans and expectations for the
VALOR-CKD trial, including early termination of the trial, 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 our key suppliers and vendors; the
Company’s financial projections and cost estimates; 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.
(Financial Tables to Follow)
Tricida, Inc.
Condensed Balance
Sheets(Unaudited)(In
thousands)
|
December 31, 2021 |
|
December 31, 2020 |
Assets |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
21,113 |
|
|
$ |
137,857 |
|
Short-term investments |
|
119,419 |
|
|
|
171,670 |
|
Prepaid expenses and other current assets |
|
5,004 |
|
|
|
4,488 |
|
Total current assets |
|
145,536 |
|
|
|
314,015 |
|
Long-term investments |
|
10,043 |
|
|
|
22,757 |
|
Property and equipment,
net |
|
769 |
|
|
|
1,112 |
|
Operating lease right-of-use
assets |
|
12,158 |
|
|
|
13,801 |
|
Total assets |
$ |
168,506 |
|
|
$ |
351,685 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
10,023 |
|
|
$ |
3,508 |
|
Current operating lease liabilities |
|
2,736 |
|
|
|
2,079 |
|
Accrued expenses and other current liabilities |
|
16,721 |
|
|
|
28,671 |
|
Total current liabilities |
|
29,480 |
|
|
|
34,258 |
|
|
|
|
|
Term Loan, net |
|
— |
|
|
|
76,638 |
|
Convertible Senior Notes,
net |
|
127,512 |
|
|
|
118,670 |
|
Non-current operating lease
liabilities |
|
11,296 |
|
|
|
13,046 |
|
Other long-term
liabilities |
|
— |
|
|
|
202 |
|
Total liabilities |
|
168,288 |
|
|
|
242,814 |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
55 |
|
|
|
50 |
|
Additional paid-in capital |
|
810,618 |
|
|
|
742,555 |
|
Accumulated other comprehensive income (loss) |
|
(91 |
) |
|
|
64 |
|
Accumulated deficit |
|
(810,364 |
) |
|
|
(633,798 |
) |
Total stockholders’ equity |
|
218 |
|
|
|
108,871 |
|
Total liabilities and stockholders’ equity |
$ |
168,506 |
|
|
$ |
351,685 |
|
Tricida, Inc.
Condensed Statements of Operations and
Comprehensive Loss(Unaudited)(In
thousands, except share and per share amounts)
|
Three Months Ended December
31, |
|
Years Ended December
31, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
36,773 |
|
|
$ |
27,283 |
|
|
$ |
115,364 |
|
|
$ |
148,417 |
|
General and administrative |
|
9,093 |
|
|
|
21,766 |
|
|
|
37,590 |
|
|
|
102,983 |
|
Total operating expenses |
|
45,866 |
|
|
|
49,049 |
|
|
|
152,954 |
|
|
|
251,400 |
|
Loss from operations |
|
(45,866 |
) |
|
|
(49,049 |
) |
|
|
(152,954 |
) |
|
|
(251,400 |
) |
Other income (expense),
net |
|
(41 |
) |
|
|
621 |
|
|
|
114 |
|
|
|
5,016 |
|
Interest expense |
|
(4,069 |
) |
|
|
(6,364 |
) |
|
|
(17,602 |
) |
|
|
(18,407 |
) |
Loss on early extinguishment
of Term Loan |
|
— |
|
|
|
— |
|
|
|
(6,124 |
) |
|
|
— |
|
Loss before income taxes |
|
(49,976 |
) |
|
|
(54,792 |
) |
|
|
(176,566 |
) |
|
|
(264,791 |
) |
Income tax benefit
(expense) |
|
— |
|
|
|
(50 |
) |
|
|
— |
|
|
|
— |
|
Net loss |
|
(49,976 |
) |
|
|
(54,842 |
) |
|
|
(176,566 |
) |
|
|
(264,791 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
Net unrealized gain (loss) on available-for-sale investments, net
of tax |
|
(14 |
) |
|
|
(368 |
) |
|
|
(155 |
) |
|
|
(129 |
) |
Total comprehensive loss |
$ |
(49,990 |
) |
|
$ |
(55,210 |
) |
|
$ |
(176,721 |
) |
|
$ |
(264,920 |
) |
Net loss per share, basic and
diluted |
$ |
(0.92 |
) |
|
$ |
(1.09 |
) |
|
$ |
(3.44 |
) |
|
$ |
(5.29 |
) |
Weighted-average number of
shares outstanding, basic and diluted |
|
54,112,250 |
|
|
|
50,186,615 |
|
|
|
51,280,697 |
|
|
|
50,027,735 |
|
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 EndedDecember
31, |
|
Years EndedDecember 31, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
GAAP net loss, as reported |
$ |
(49,976 |
) |
|
$ |
(54,842 |
) |
|
$ |
(176,566 |
) |
|
$ |
(264,791 |
) |
Adjustments: |
|
|
|
|
|
|
|
Non-cash operating lease costs |
|
(24 |
) |
|
|
248 |
|
|
|
550 |
|
|
|
845 |
|
Accretion of Term Loan and Convertible Senior Notes |
|
2,318 |
|
|
|
3,012 |
|
|
|
9,365 |
|
|
|
8,258 |
|
Loss on early extinguishment of Term Loan |
|
— |
|
|
|
— |
|
|
|
6,124 |
|
|
|
— |
|
Stock-based compensation |
|
6,582 |
|
|
|
3,190 |
|
|
|
25,882 |
|
|
|
28,298 |
|
Changes in compound derivative liability |
|
— |
|
|
|
(76 |
) |
|
|
(202 |
) |
|
|
(775 |
) |
Restructuring costs |
|
(1 |
) |
|
|
11,089 |
|
|
|
106 |
|
|
|
13,749 |
|
Total adjustments |
|
8,875 |
|
|
|
17,463 |
|
|
|
41,825 |
|
|
|
50,375 |
|
Non-GAAP net loss |
$ |
(41,101 |
) |
|
$ |
(37,379 |
) |
|
$ |
(134,741 |
) |
|
$ |
(214,416 |
) |
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, 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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