10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-40560

 

ProKidney Corp.

(Exact Name of Registrant as Specified in its Charter)

 

 

Cayman Islands

98-1586514

( State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

2000 Frontis Plaza Blvd., Suite 250

Winston-Salem, NC

27103

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (336) 999-7028

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Class A ordinary shares, $0.0001 par value per share

 

PROK

 

The Nasdaq Stock Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes No

Class of Stock

 

Shares Outstanding as of August 10, 2023

Class A ordinary shares, par value $0.0001 per share

 

61,590,231

 


 

Class B ordinary shares, par value $0.0001 per share

 

173,663,427

\`

 


 

Table of Contents

 

Page

PART I.

Financial Information (Unaudited)

2

Item 1.

Financial Statements

2

Condensed Consolidated Balance Sheets

2

Condensed Consolidated Statements of Operations

3

 

Condensed Consolidated Statements of Comprehensive Loss

4

 

Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit / Members’ Equity

6

Condensed Consolidated Statements of Cash Flows

7

Notes to Unaudited Condensed Consolidated Financial Statements

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

22

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

31

Item 4.

Controls and Procedures

31

PART II.

Other Information

32

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

32

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

32

Item 3.

Defaults Upon Senior Securities

32

Item 4.

Mine Safety Disclosures

32

Item 5.

Other Information

32

Item 6.

Exhibits

32

Signatures

34

 

i


 

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements.

ProKidney Corp.

Condensed Consolidated Balance Sheets

(in thousands, except share data)

 

 

June 30, 2023

 

 

December 31, 2022

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

Cash and cash equivalents

$

243,553

 

 

$

490,252

 

Marketable securities

 

202,575

 

 

 

 

Interest receivable

 

8,090

 

 

 

 

Prepaid assets

 

4,226

 

 

 

2,624

 

Prepaid clinical

 

7,385

 

 

 

10,459

 

Other current assets

 

603

 

 

 

1,384

 

Total current assets

 

466,432

 

 

 

504,719

 

 

 

 

 

 

 

Fixed assets, net

 

14,803

 

 

 

10,708

 

Right of use assets, net

 

2,880

 

 

 

2,356

 

Intangible assets, net

 

106

 

 

 

213

 

Total assets

$

484,221

 

 

$

517,996

 

 

 

 

 

 

 

Liabilities and Shareholders' Deficit/Members' Equity

 

 

 

 

 

Accounts payable

$

2,832

 

 

$

3,044

 

Lease liabilities

 

654

 

 

 

493

 

Accrued expenses and other

 

20,945

 

 

 

7,336

 

Income taxes payable

 

66

 

 

 

 

Total current liabilities

 

24,497

 

 

 

10,873

 

 

 

 

 

 

 

Income tax payable, net of current portion

 

494

 

 

 

278

 

Lease liabilities, net of current portion

 

2,286

 

 

 

1,906

 

Total liabilities

 

27,277

 

 

 

13,057

 

Commitments and contingencies

 

 

 

 

 

Redeemable noncontrolling interest

 

1,779,198

 

 

 

1,601,555

 

 

 

 

 

 

 

Shareholders’ deficit / members' equity:

 

 

 

 

 

Class A ordinary shares, $0.0001 par value; 500,000,000 shares
   authorized;
61,590,231 and 61,540,231 issued and outstanding as
   of June 30, 2023 and December 31, 2022, respectively

 

6

 

 

 

6

 

Class B ordinary shares, $0.0001 par value; 500,000,000 shares
   authorized;
173,663,427 and 171,578,320 issued and outstanding as
   of June 30, 2023 and December 31, 2022, respectively

 

18

 

 

 

18

 

Additional paid-in capital

 

30,957

 

 

 

7,476

 

Accumulated other comprehensive loss

 

(127

)

 

 

 

Accumulated deficit

 

(1,353,108

)

 

 

(1,104,116

)

Total shareholders' deficit / members’ equity

 

(1,322,254

)

 

 

(1,096,616

)

Total liabilities and shareholders' deficit/members' equity

$

484,221

 

 

$

517,996

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

2


 

ProKidney Corp.

Condensed Consolidated Statements of Operations - Unaudited

(in thousands, except for share and per share data)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

26,364

 

 

$

11,558

 

 

$

51,981

 

 

$

40,048

 

General and administrative

 

 

13,455

 

 

 

9,180

 

 

 

28,714

 

 

 

47,152

 

Total operating expenses

 

 

39,819

 

 

 

20,738

 

 

 

80,695

 

 

 

87,200

 

Operating loss

 

 

(39,819

)

 

 

(20,738

)

 

 

(80,695

)

 

 

(87,200

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

5,965

 

 

 

 

 

 

11,262

 

 

 

 

Interest expense

 

 

(4

)

 

 

(170

)

 

 

(7

)

 

 

(184

)

Net loss before income taxes

 

 

(33,858

)

 

 

(20,908

)

 

 

(69,440

)

 

 

(87,384

)

Income tax expense

 

 

965

 

 

 

1,223

 

 

 

2,292

 

 

 

2,233

 

Net loss before noncontrolling
   interest

 

 

(34,823

)

 

 

(22,131

)

 

 

(71,732

)

 

 

(89,617

)

Net loss attributable to noncontrolling interest

 

 

(25,705

)

 

 

 

 

 

(52,949

)

 

 

 

Net loss available to Class A ordinary shareholders

 

$

(9,118

)

 

$

(22,131

)

 

$

(18,783

)

 

$

(89,617

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average Class A ordinary shares outstanding: (1)

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

64,562,209

 

 

 

 

 

 

64,551,281

 

 

 

 

Net loss per share attributable to Class A ordinary shares: (1)

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.14

)

 

 

 

 

$

(0.29

)

 

 

 

 

(1) The Company analyzed the calculation of net loss per share for periods prior to the Business Combination, as defined in Note 1, on July 11, 2022 and determined that it resulted in values that would not be meaningful to the users of the consolidated financial statements, as the capital structure completely changed as a result of the Business Combination. Therefore, net loss per share information has not been presented for periods prior to the Business Combination. For more information refer to Note 8.

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3


 

ProKidney Corp.

Condensed Consolidated Statements of Comprehensive Loss - Unaudited

(in thousands, except for share and per share data)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Net loss including noncontrolling interest

 

$

(34,823

)

 

$

(22,131

)

 

$

(71,732

)

 

$

(89,617

)

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

 

(413

)

 

 

 

 

 

(485

)

 

 

 

Other comprehensive loss

 

 

(413

)

 

 

 

 

 

(485

)

 

 

 

Total comprehensive loss including noncontrolling interest

 

 

(35,236

)

 

 

(22,131

)

 

 

(72,217

)

 

 

(89,617

)

Less: Total comprehensive loss attributable to noncontrolling interest

 

 

(26,010

)

 

 

 

 

 

(53,307

)

 

 

 

Total comprehensive loss attributable to Class A ordinary shareholders

 

$

(9,226

)

 

$

(22,131

)

 

$

(18,910

)

 

$

(89,617

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

4


 

ProKidney Corp.

Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit / Members’ Equity - Unaudited

(in thousands, except for share and per share data)

 

 

 

For the Three Months Ended June 30, 2023

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Class A Ordinary Shares

 

 

Class B Ordinary Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redeemable Noncontrolling Interest

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Accumulated Other Comprehensive Loss

 

 

Accumulated Deficit

 

 

Total Shareholders' Deficit / Members' Equity

 

Balance as of April 1, 2023

 

$

2,082,488

 

 

 

 

61,540,231

 

 

$

6

 

 

 

173,444,861

 

 

$

18

 

 

$

21,792

 

 

$

(19

)

 

$

(1,623,307

)

 

$

(1,601,510

)

Equity-based compensation

 

 

2,762

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,440

 

 

 

 

 

 

 

 

 

8,440

 

Issuance of Class A ordinary shares

 

 

 

 

 

 

50,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of Class B restricted stock rights

 

 

 

 

 

 

 

 

 

 

 

 

218,566

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Impact of equity transactions on redeemable noncontrolling interest

 

 

(725

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

725

 

 

 

 

 

 

 

 

 

725

 

Unrealized loss on marketable securities

 

 

(305

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(108

)

 

 

 

 

 

(108

)

Net loss

 

 

(25,705

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,118

)

 

 

(9,118

)

Change in redemption value of noncontrolling interest

 

 

(279,317

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

279,317

 

 

 

279,317

 

Balance as of June 30, 2023

 

$

1,779,198

 

 

 

 

61,590,231

 

 

$

6

 

 

 

173,663,427

 

 

$

18

 

 

$

30,957

 

 

$

(127

)

 

$

(1,353,108

)

 

$

(1,322,254

)

 

 

 

For the Three Months Ended June 30, 2022

 

 

 

Class A

 

 

Class B

 

 

Accumulated

 

 

Total Members'

 

 

 

Units

 

 

Amount

 

 

Profits Interests

 

 

Deficit

 

 

Equity

 

Balance as of April 1, 2022

 

 

186,500,000

 

 

 

186,500

 

 

 

62,663

 

 

 

(228,996

)

 

 

20,167

 

Capital contribution

 

 

 

 

 

 

 

 

500

 

 

 

 

 

 

500

 

Equity-based payments

 

 

 

 

 

 

 

 

8,001

 

 

 

 

 

 

8,001

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(22,131

)

 

 

(22,131

)

Balance as of June 30, 2022

 

 

186,500,000

 

 

$

186,500

 

 

$

71,164

 

 

$

(251,127

)

 

$

6,537

 

 

5


 

ProKidney Corp.

Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders’ Deficit / Members’ Equity - Unaudited

(in thousands, except for share and per share data)

 

 

 

For the Six Months Ended June 30, 2023

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Class A Ordinary Shares

 

 

Class B Ordinary Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Redeemable Noncontrolling Interest

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Additional Paid-in Capital

 

 

Accumulated Other Comprehensive Loss

 

 

Accumulated Deficit

 

 

Total Shareholders' Deficit / Members' Equity

 

Balance as of January 1, 2023

 

 

1,601,555

 

 

 

 

61,540,231

 

 

 

6

 

 

 

171,578,320

 

 

 

18

 

 

 

7,476

 

 

 

 

 

 

(1,104,116

)

 

 

(1,096,616

)

Equity-based compensation

 

 

5,219

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

19,003

 

 

 

 

 

 

 

 

 

19,003

 

Issuance of Class A ordinary shares

 

 

 

 

 

 

50,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of Class B restricted stock rights

 

 

 

 

 

 

 

 

 

 

 

 

2,085,107

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Impact of equity transactions on redeemable noncontrolling interest

 

 

(4,478

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,478

 

 

 

 

 

 

 

 

 

4,478

 

Unrealized loss on marketable securities

 

 

(358

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(127

)

 

 

 

 

 

(127

)

Net loss

 

 

(52,949

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,783

)

 

 

(18,783

)

Change in redemption value of noncontrolling interest

 

 

230,209

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(230,209

)

 

 

(230,209

)

Balance as of June 30, 2023

 

$

1,779,198