Webcast Today at 4:30 pm Eastern Time
Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused
on the development and commercialization of its 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
three and six months ended June 30, 2020 and provided an update on
key initiatives.
Recent Events
- On May 22, 2020, Tricida completed an offering of $200.0
million of its 3.50% Convertible Senior Notes due 2027. Net
proceeds from the offering were $193.3 million, after deducting
underwriting discounts and commissions and other offering
costs.
- In early July, Tricida deployed its field force of
approximately 40 Specialty Account Managers in key geographic
regions to communicate directly with 70% to 80% of the 5,000
highest-prescribing nephrologists in the United States. The
Specialty Account Managers have initiated metabolic acidosis
disease awareness education, and to date, have conducted nearly
6000 virtual or in-person engagements with nephrologists and their
staff, hosted numerous nephrologists’ roundtable meetings and
arranged peer-to-peer educational events.
- On July 14, 2020, Tricida received a notification from the U.S.
Food and Drug Administration (FDA) stating that, as part of its
ongoing review of the company’s New Drug Application (NDA), the FDA
has identified deficiencies that preclude discussion of labeling
and postmarketing requirements/commitments at this time. The
notification does not specify the deficiencies identified by the
FDA. The FDA stated that the notification does not reflect a final
decision on the information under review. The company plans to work
with the FDA to identify and seek to resolve the deficiencies.
Upcoming Events and Projected Milestones
- The FDA assigned a Prescription Drug User Fee Act, or PDUFA,
goal date of August 22, 2020 for the potential approval to market
veverimer in the United States. Tricida anticipates that it will
receive further clarification related to the FDA notification of
July 14, 2020 on or before the PDUFA goal date of August 22, 2020.
While the company has no additional information from the FDA since
the July 14, 2020 notification, at this time, the company believes
it is unlikely to receive approval to market veverimer in the
United States on the PDUFA goal date.
- Tricida plans to complete enrollment of patients in its
VALOR-CKD confirmatory postmarketing trial in first half of 2021.
The VALOR-CKD trial is an outcomes trial comparing veverimer versus
placebo in time to renal disease progression in patients with
metabolic acidosis and chronic kidney disease (CKD).
“While we won’t speculate what the FDA notification may entail,
we are preparing for all eventualities to swiftly resolve any
potential issues. However, we remain confident in the fundamentals
of veverimer and its underlying value proposition,” said Gerrit
Klaerner, Ph.D., Tricida’s Chief Executive Officer and President.
“I am reassured by the feedback that we have received from our
Specialty Account Managers from their initial interactions with
community nephrologists that confirms the unmet need to treat
metabolic acidosis.”
Financial Results for the Three and Six Months Ended June 30,
2020
Research and development expense was $28.8 million and $29.0
million for the three months ended June 30, 2020 and 2019,
respectively, and $78.1 million and $60.4 million for the six
months ended June 30, 2020 and 2019, respectively. The decrease in
research and development expense for the three months ended June
30, 2020 compared to the prior year was primarily due to decreased
activities in connection with our veverimer clinical development
program related to reduced expenditures in our clinical trials,
partially offset by an increase in manufacturing process
optimization and increased personnel costs. The increase in
research and development expense for the six months ended June 30,
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, as well as increased personnel
costs.
General and administrative expense was $28.4 million and $8.9
million for the three months ended June 30, 2020 and 2019,
respectively, and $51.9 million and $15.2 million for the six
months ended June 30, 2020 and 2019, respectively. The increases in
general and administrative expense in the three and six months
ended June 30, 2020 compared to the three and six months ended June
30, 2019 were primarily due to increased administrative costs
supporting the increased activities in connection with our
veverimer clinical development program, including
pre-commercialization, Medical Affairs, professional service costs,
and increased personnel costs.
Net loss was $58.2 million (non-GAAP net loss of $48.9 million)
and $36.6 million (non-GAAP net loss of $31.5 million) for the
three months ended June 30, 2020 and 2019, respectively, and $132.3
million (non-GAAP net loss of $112.8 million) and $74.5 million
(non-GAAP net loss of $65.9 million) for the six months ended June
30, 2020 and 2019, respectively. Net loss per basic and diluted
share was $1.16 and $0.75 for the three months ended June 30, 2020
and 2019, respectively, and $2.65 and $1.64 for the six months
ended June 30, 2020 and 2019, respectively.
As of June 30, 2020, cash, cash equivalents and investments were
$436.9 million.
Today’s Conference Call and Webcast
Tricida will host a conference call today at 4:30 pm Eastern
Time to discuss its financial results and business progress. Please
access the Tricida Conference Call as follows:
Tricida Second Quarter 2020
Conference Call
4:30 pm Eastern Time
Today
Webcast:
IR.Tricida.com
Dial-in:
(877) 377-5478
International:
(629) 228-0740
Conference ID:
8994536
A replay of the webcast will be available on the Investor
Relations page of 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 drug candidate, veverimer
(TRC101), a non-absorbed, orally-administered polymer designed to
treat metabolic acidosis in patients 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 three million patients with
CKD in the United States. Tricida is currently conducting its
confirmatory postmarketing trial, VALOR-CKD, of veverimer. The
Tricida NDA for veverimer has been accepted for review by the FDA
through the Accelerated Approval Program. The FDA has assigned a
PDUFA goal date of August 22, 2020.
For more information about Tricida, please visit
www.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 and Section 21E of
the Securities Exchange Act of 1934 (“Exchange Act”).
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 Events and
Projected Milestones” and other statements, including the potential
receipt and timing of the FDA’s approval of the NDA, the potential
receipt and timing of further clarification related to the FDA
notification of July 14, 2020, the potential availability of the
Accelerated Approval Program, as well as the approvability of
veverimer under that program, the Company’s expectations with
regard to its interactions and communications with the FDA, plans
and expectations as to the PDUFA date, and statements regarding the
therapeutic potential of, and potential clinical and commercial
development plans for, veverimer. Forward-looking statements
involve known and unknown risks, uncertainties, assumptions and
other factors that may cause our actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. These risks and uncertainties include,
among others, that we may not be able to address all of the issues
that relate to the deficiencies the FDA may identify with respect
to veverimer; that we may not be able to achieve upcoming
milestones; the cost, timing and results of clinical trials and
other studies; that many drug candidates that have completed Phase
3 trials do not become approved drugs on a timely or cost effective
basis, or at all; there can be no assurance that the FDA would
approve an NDA through the Accelerated Approval Program, or at all,
and even if approval for a drug is obtained, there can be no
assurance that it will be adopted in the market or accepted as a
benefit to patients and healthcare providers; possible safety and
efficacy concerns; and that we completely rely on third-party
suppliers and manufacturers for many aspects of our business. These
and other factors that may affect our future results of operations
are identified and described in more detail in our filings with the
Securities and Exchange Commission, including the Company’s most
recent Annual Report filed on Form 10-K and our subsequently filed
Quarterly Reports 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, 2020
December 31, 2019
Assets
Current assets:
Cash and cash equivalents
$
41,900
$
18,574
Short-term investments
345,632
289,424
Prepaid expenses and other current
assets
9,830
4,744
Total current assets
397,362
312,742
Long-term investments
49,371
46,980
Property and equipment, net
1,432
2,728
Operating lease right-of-use assets
8,734
9,376
Total assets
$
456,899
$
371,826
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
5,839
$
5,911
Current operating lease liabilities
1,088
1,072
Current Term Loan
6,784
—
Accrued expenses and other current
liabilities
20,769
32,780
Total current liabilities
34,480
39,763
Non-current Term Loan, net
67,952
58,374
Convertible Senior Notes, net
114,645
—
Non-current operating lease
liabilities
8,515
8,783
Other long-term liabilities
327
1,023
Total liabilities
225,919
107,943
Stockholders’ equity:
Preferred stock
—
—
Common stock
50
50
Additional paid-in capital
731,358
632,647
Accumulated other comprehensive income
(loss)
863
193
Accumulated deficit
(501,291
)
(369,007
)
Total stockholders’ equity
230,980
263,883
Total liabilities and stockholders’
equity
$
456,899
$
371,826
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,
2020
2019
2020
2019
Operating expenses:
Research and development
$
28,757
$
28,976
$
78,138
$
60,399
General and administrative
28,418
8,861
51,944
15,213
Total operating expenses
57,175
37,837
130,082
75,612
Loss from operations
(57,175
)
(37,837
)
(130,082
)
(75,612
)
Other income (expense), net
2,675
2,602
3,488
3,869
Interest expense
(3,756
)
(1,391
)
(5,776
)
(2,780
)
Loss before income taxes
(58,256
)
(36,626
)
(132,370
)
(74,523
)
Income tax benefit
86
—
86
—
Net loss
(58,170
)
(36,626
)
(132,284
)
(74,523
)
Other comprehensive income (loss):
Net unrealized gain (loss) on
available-for-sale investments, net of tax
902
480
670
782
Total comprehensive loss
$
(57,268
)
$
(36,146
)
$
(131,614
)
$
(73,741
)
Net loss per share, basic and diluted
$
(1.16
)
$
(0.75
)
$
(2.65
)
$
(1.64
)
Weighted-average number of shares
outstanding, basic and diluted
49,960,072
48,674,238
49,900,739
45,489,861
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,
2020
2019
2020
2019
GAAP net loss, as reported
$
(58,170
)
$
(36,626
)
$
(132,284
)
$
(74,523
)
Adjustments:
Non-cash operating lease costs
70
209
390
413
Stock-based compensation
9,079
4,413
17,453
7,071
Accretion of Term Loan and Convertible
Senior Notes
1,580
523
2,331
1,011
Changes in fair value of compound
derivative liability
(1,496
)
(9
)
(650
)
165
Total adjustments
9,233
5,136
19,524
8,660
Non-GAAP net loss
$
(48,937
)
$
(31,490
)
$
(112,760
)
$
(65,863
)
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) stock-based compensation,
(3) accretion of Term Loan and Convertible Senior Notes and (4)
changes in fair value of compound derivative liability, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200805005910/en/
Jackie Cossmon Tricida, Inc. Senior Vice President of Investor
Relations and Communications IR@Tricida.com
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