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Tricida Announces Second Quarter 2022 Financial Results

TCDA

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.