Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused
on the development and commercialization of its investigational
drug candidate, veverimer (TRC101), a non-absorbed,
orally-administered polymer designed to treat metabolic acidosis in
patients with chronic kidney disease (CKD), announced today
financial results for the fourth quarter and year ended December
31, 2020 and provided an update on key initiatives.
Recent Events
- As announced separately today,
Tricida has 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 continues to effectively
execute on VALOR-CKD trial recruitment and conduct. As of February
22, 2021, the VALOR-CKD trial has randomized 1,433 of 1,600
subjects with an average treatment duration of approximately one
year and has accrued 69 of the 511 required subjects with
positively adjudicated primary endpoint events.
- Tricida announced that Geoffrey
Parker, Chief Financial Officer and Executive Vice President has
been promoted to the newly created role of Chief Operating Officer,
Chief Financial Officer and Executive Vice President. In his
expanded role, Mr. Parker will continue to lead all finance and
accounting activities and additionally focus on corporate and
business development strategies.
2020 Key Events
Tricida’s key events and activities in 2020 include:
- Received a Complete Response Letter
(CRL) for its veverimer New Drug Application (NDA) in August
2020;
- Held an End-of-Review Type A
meeting in response to the CRL in October 2020;
- Submitted the FDRR to the OND in
December 2020;
- Restructured the company in the
second half of 2020 in order to maximize the options for bringing
veverimer to patients;
- Presented or published 20
peer-reviewed posters or articles that highlight veverimer, the
serious complications of metabolic acidosis and its economic burden
to the healthcare system;
- Engaged with 126 payers
representing approximately 310 million lives to evaluate coverage
of veverimer, if approved, provide information about the design and
results of our health economic study and share veverimer clinical
trial data;
- Expanded metabolic acidosis disease
education and awareness through the sponsorship of Continuing
Medical Education (CME) programs, and enhanced educational
materials available through the MetabolicAcidosisInsights.com
website;
- Continued successful execution on
its global IP strategy, resulting in the allowance of a U.S. patent
application that, upon issuance in 2021 will extend protection for
veverimer to 2038 in the U.S., and the issuance of an additional
126 patents in 47 different countries, including Australia, China,
Israel, Japan, Russia and numerous European and European extension
states; and
- Issued, in May 2020, $200 million
aggregate principal amount of 3.50% convertible senior notes due
2027, securing additional capital to fund operations.
“We accomplished a great deal in 2020 but were obviously
disappointed that we could not launch veverimer as the first and
only FDA-approved treatment for chronic metabolic acidosis in
patients with CKD,” said Gerrit Klaerner, Ph.D., Tricida’s Chief
Executive Officer and President. “We will now focus on the
VALOR-CKD trial to generate additional data prior to the end of
2022.”
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 primary renal endpoint
events are expected to have accrued. A primary endpoint event in
the VALOR-CKD trial is defined as renal death, end-stage renal
disease (ESRD) or a confirmed ≥ 40% reduction in estimated
glomerular filtration rate (eGFR), also known as DD40. If the
independent unblinded Interim Analysis Committee does not recommend
stopping the trial early for efficacy, we 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 primary renal endpoint events are
expected to have accrued. If the independent unblinded Interim
Analysis Committee does not recommend stopping the trial early for
efficacy, we will receive no information from this interim
analysis.
- Prior to the end of 2022, the
company will also evaluate options with a focus on obtaining
additional data from the VALOR-CKD trial on the effects of
veverimer on (1) CKD progression; (2) physical functioning;
and (3) serum bicarbonate. These options include the possibility of
stopping the trial early for administrative reasons, which would
allow analysis of the data using all alpha remaining at that
time.
Financial Results for the Three Months and Year Ended
December 31, 2020
Research and development expense was $27.3 million and $40.7
million for the three months ended December 31, 2020 and 2019,
respectively, and $148.4 million and $133.0 million for the years
ended December 31, 2020 and 2019, respectively. The decrease in
research and development expense for the three months ended
December 31, 2020 compared to the prior year was primarily due to a
decrease in activities in connection with our veverimer clinical
development program related to manufacturing process optimization
and the manufacturing of drug substance and lower personnel costs.
The increase in research and development expense for the year ended
December 31, 2020 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, partially offset by lower
personnel costs.
General and administrative expense was $21.8 million and $17.5
million for the three months ended December 31, 2020 and 2019,
respectively, and $103.0 million and $45.8 million for the years
ended December 31, 2020 and 2019, respectively. The increase in
general and administrative expense for the three months ended
December 31, 2020 compared to the prior year was primarily due to
restructuring costs including one-time termination severance
payments and contract termination costs, partially offset by lower
pre-commercialization and other administrative costs due to a
decrease in activities in connection with our veverimer clinical
development program. The increase in general and administrative
expense for the year ended December 31, 2020 compared to the prior
year was primarily due to increased pre-commercialization and
associated administrative activities in connection with our
veverimer clinical development program and restructuring costs
including one-time termination severance payments and contract
termination costs.
Net loss was $54.8 million (non-GAAP net loss of $33.0 million)
and $58.2 million (non-GAAP net loss of $47.3 million) for the
three months ended December 31, 2020 and 2019, respectively, and
$264.8 million (non-GAAP net loss of $214.4 million) and $176.8
million (non-GAAP net loss of $147.7 million) for the years ended
December 31, 2020 and 2019, respectively. Net loss per basic and
diluted share was $1.09 and $1.17 for the three months ended
December 31, 2020 and 2019, respectively, and $5.29 and $3.72 for
the years ended December 31, 2020 and 2019, respectively.
As of December 31, 2020, cash, cash equivalents and investments
were $332.3 million.
Financial Guidance
Tricida currently has the financial resources to fund its
operations into at least mid-2022, prior to modifying any of its
material agreements. Discussions are ongoing to modify certain of
these agreements and, if successful, would extend the company’s
financial resources beyond mid-2022. Tricida plans to obtain
additional data on the effect of veverimer on (1) CKD progression;
(2) physical functioning; and (3) serum bicarbonate within the
time frame of our existing capital resources.
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
Conference Call |
Thursday,
February 25, 2021 |
4:30 pm
Eastern Time |
Webcast: |
|
IR.Tricida.com |
Dial-In: |
|
(800) 773-2954 |
International: |
|
(847) 413-3731 |
Conference ID: |
|
50111253 |
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 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
other statements, including the Company’s plans and expectations
for VALOR-CKD, its interactions and communications with the FDA,
its plans and expectations as to the pathway to approval of
veverimer by the FDA, if at all, including the potential
availability of the Accelerated Approval Program, 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 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. 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 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 31,2020 |
|
December 31,2019 |
Assets |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
137,857 |
|
|
$ |
18,574 |
|
Short-term investments |
171,670 |
|
|
289,424 |
|
Prepaid expenses and other current assets |
4,488 |
|
|
4,744 |
|
Total current assets |
314,015 |
|
|
312,742 |
|
Long-term investments |
22,757 |
|
|
46,980 |
|
Property and equipment, net |
1,112 |
|
|
2,728 |
|
Operating lease right-of-use
assets |
13,801 |
|
|
9,376 |
|
Total assets |
$ |
351,685 |
|
|
$ |
371,826 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
3,508 |
|
|
$ |
5,911 |
|
Current operating lease liabilities |
2,079 |
|
|
1,072 |
|
Accrued expenses and other current liabilities |
28,671 |
|
|
32,780 |
|
Total current liabilities |
34,258 |
|
|
39,763 |
|
|
|
|
|
Term Loan, net |
76,638 |
|
|
58,374 |
|
Convertible Senior Notes,
net |
118,670 |
|
|
— |
|
Non-current operating lease
liabilities |
13,046 |
|
|
8,783 |
|
Other long-term liabilities |
202 |
|
|
1,023 |
|
Total liabilities |
242,814 |
|
|
107,943 |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock |
— |
|
|
— |
|
Common stock |
50 |
|
|
50 |
|
Additional paid-in capital |
742,555 |
|
|
632,647 |
|
Accumulated other comprehensive income (loss) |
64 |
|
|
193 |
|
Accumulated deficit |
(633,798 |
) |
|
(369,007 |
) |
Total stockholders’ equity |
108,871 |
|
|
263,883 |
|
Total liabilities and stockholders’ equity |
$ |
351,685 |
|
|
$ |
371,826 |
|
Tricida, Inc.
Statements of Operations and
Comprehensive Loss(Unaudited)(In
thousands, except share and per share amounts)
|
Three Months EndedDecember
31, |
|
Years EndedDecember 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
27,283 |
|
|
$ |
40,653 |
|
|
$ |
148,417 |
|
|
$ |
133,028 |
|
General and administrative |
21,766 |
|
|
17,463 |
|
|
102,983 |
|
|
45,796 |
|
Total operating expenses |
49,049 |
|
|
58,116 |
|
|
251,400 |
|
|
178,824 |
|
Loss from operations |
(49,049 |
) |
|
(58,116 |
) |
|
(251,400 |
) |
|
(178,824 |
) |
Other income (expense), net |
621 |
|
|
1,407 |
|
|
5,016 |
|
|
7,663 |
|
Interest expense |
(6,364 |
) |
|
(1,554 |
) |
|
(18,407 |
) |
|
(5,744 |
) |
Loss before income taxes |
(54,792 |
) |
|
(58,263 |
) |
|
(264,791 |
) |
|
(176,905 |
) |
Income tax benefit
(expense) |
(50 |
) |
|
92 |
|
|
— |
|
|
92 |
|
Net loss |
(54,842 |
) |
|
(58,171 |
) |
|
(264,791 |
) |
|
(176,813 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
Net unrealized gain (loss) on available-for-sale investments, net
of tax |
(368 |
) |
|
(293 |
) |
|
(129 |
) |
|
346 |
|
Total comprehensive loss |
$ |
(55,210 |
) |
|
$ |
(58,464 |
) |
|
$ |
(264,920 |
) |
|
$ |
(176,467 |
) |
Net loss per share, basic and
diluted |
$ |
(1.09 |
) |
|
$ |
(1.17 |
) |
|
$ |
(5.29 |
) |
|
$ |
(3.72 |
) |
Weighted-average number of shares
outstanding, basic and diluted |
50,186,615 |
|
|
49,620,063 |
|
|
50,027,735 |
|
|
47,521,237 |
|
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, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
GAAP net loss, as reported |
$ |
(54,842 |
) |
|
$ |
(58,171 |
) |
|
$ |
(264,791 |
) |
|
$ |
(176,813 |
) |
Adjustments: |
|
|
|
|
|
|
|
Non-cash operating lease costs |
207 |
|
|
318 |
|
|
845 |
|
|
964 |
|
Accretion of Term Loan and Convertible Senior Notes |
2,915 |
|
|
609 |
|
|
8,258 |
|
|
2,173 |
|
Stock-based compensation |
7,655 |
|
|
9,415 |
|
|
28,298 |
|
|
25,168 |
|
Changes in fair value of compound derivative liability |
(49 |
) |
|
557 |
|
|
(775 |
) |
|
816 |
|
Restructuring costs |
11,089 |
|
|
— |
|
|
13,749 |
|
|
— |
|
Total adjustments |
21,817 |
|
|
10,899 |
|
|
50,375 |
|
|
29,121 |
|
Non-GAAP net loss |
$ |
(33,025 |
) |
|
$ |
(47,272 |
) |
|
$ |
(214,416 |
) |
|
$ |
(147,692 |
) |
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) stock-based compensation, (4) changes in fair value
of compound derivative liability, and (5) 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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