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 SeptemberJune 30, 20192020

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: 001-37785

 

Reata Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

 

11-3651945

(State or other jurisdiction of

incorporation or organization)

 

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

 

 

 

5320 Legacy Drive  
Plano, Texas

 

75024

(Address of principal executive offices)

 

(Zip Code)

(972) 865-2219

(Registrant’s telephone number, including area code)

2801 Gateway Drive, Suite 150

Irving, Texas 75063

(Former name, former address and former fiscal year, if changes since last report)

 

 

Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Class A Common Stock, Par Value $0.001 Per Share

 

RETA

 

NASDAQ Global 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, an emerging growth company, or a smaller reporting 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 

As of November 7, 2019,August 5, 2020, the registrant had 24,765,41028,559,247 shares of Class A common stock, $0.001 par value per share, and 5,506,4955,045,092 shares of Class B common stock, $0.001 par value per share, outstanding.

 

 

 

 


TABLE OF CONTENTS

 

 

 

Page

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

1

DEFINED TERMS

3

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

4

 

Consolidated Balance Sheets

4

 

Consolidated Statements of Operations

5

 

Consolidated Statements of Stockholders’ Equity (Deficit)

6

 

Consolidated Statements of Cash Flows

7

 

Notes to Unaudited Consolidated Financial Statements

8

Item 2.

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

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

3534

Item 4.

Controls and Procedures

35

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

3635

Item 1A.

Risk Factors

3635

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

3635

Item 3.

Defaults Upon Senior Securities

3635

Item 4.

Mine Safety Disclosures

36

Item 5.

Other Information

36

Item 6.

Exhibits

37

Signatures

38

 

 

 

 

i


 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties.  We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.  AllIn this Quarterly Report on Form 10-Q, all statements, other than statements of historical or present facts, including statements regarding our future financial condition, future revenues, projected costs, prospects, business strategy, and plans and objectives of management for future operations, are forward-looking statements.  In some cases, you can identify forward-looking statements by terminology such as “believe,” “will,” “may,” “might,” “estimate,” “continue,” “anticipate,” “intend,” “target,” “project,” “model,” “should,” “would,” “plan,” “expect,” “predict,” “could,” “seek,” “goals,” “potential,”  and similar terms or expressions that concern our expectations, strategy, plans, or intentions.  These forward-looking statements include, but are not limited to, statements about:

 

our expectations regarding the timing, costs, conduct, and outcome of our clinical trials, including statements regarding the timing of the initiation and availability of data from such trials;

 

the timing and likelihood of regulatory filings and approvals for our product candidates;

whether regulatory authorities determine that additional trials or data are necessary in order to accept a new drug application for review and/or approval;

 

our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;

 

our plans to research, develop, and commercialize our product candidates;

 

the commercialization of our product candidates, if approved;

 

the rate and degree of market acceptance of our product candidates;

 

our expectations regarding the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the potential market opportunities for commercializing our product candidates;

 

the success of competing therapies that are or may become available;

 

our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates;

 

theour ability to license additional intellectual property relating to our product candidates and to comply with our existing license agreements;

 

our ability to maintain and establish relationships with third parties, such as contract research organizations, suppliers, and distributors;

 

our ability to maintain and establish collaborators with development, regulatory, and commercialization expertise;

 

our ability to attract and retain key scientific or management personnel;

 

our ability to grow our organization and increase the size of our facilities to meet our anticipated growth;

 

the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing;

 

our expectations related to the use of our available cash;

 

our ability to develop, acquire, and advance product candidates into, and successfully complete, clinical trials;


 

the initiation, timing, progress, and results of future preclinical studies and clinical trials, and our research and development programs;

 

the impact of governmental laws and regulations and regulatory developments in the United States and foreign countries;

 

developments and projections relating to our competitors and our industry; and


 

the impact of the coronavirus disease (COVID-19) on our clinical trials, our supply chain, and our operations; and

other risks and uncertainties, including those described under the heading “Risk Factors” included in our most recent Annual Report on Form 10-K for the year ended December 31, 2018,2019, filed with the SECU.S. Securities and Exchange Commission (SEC) on February 28, 2019, 19, 2020, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019,March 31, 2020, filed with the SEC on August 8, 2019.May 11, 2020.

Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties, 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 these forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect.  Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.


DEFINED TERMS

Unless the context requires otherwise, references to “Reata,” “the Company,” “we,” “us,” or “our” in this Quarterly Report on Form 10-Q refer to Reata Pharmaceuticals, Inc. and its subsidiaries.  We also have used several other terms in this Quarterly Report on Form 10-Q, most of which are explained or defined below.

 

Abbreviated Term

 

Defined Term

6MWD

6-minute walk distance

AbbVie

 

AbbVie Inc.

ADPKD

 

Autosomal dominant polycystic kidney disease

ASU

 

Accounting Standards Update

Bardoxolone

 

Bardoxolone methyl

BXLS

Blackstone Life Sciences, LLC

CARES Act

Coronavirus Aid, Relief, and Economic Security Act

CKD

 

Chronic kidney disease

COVID-19

Coronavirus disease

CRO

 

Contract research organization

CTD-PAH

Pulmonary arterial hypertension associated with connective tissue disease

DSMB

Data safety monitoring board

EGC

Emerging growth company

eGFR

 

Estimated glomerular filtration rate

ESKD

 

End stage kidney disease

Exchange Act

 

Securities Exchange Act of 1934

FA

 

Friedreich’s ataxia

FARA

Friedreich’s Ataxia Research Alliance

FASB

 

Financial Accounting Standards Board

FDA

 

United States Food and Drug Administration

FSGS

 

Focal segmental glomerulosclerosis

GFR

 

Glomerular filtration rate

IgAN

 

IgA nephropathy

I-PAHIST

 

Idiopathic form of PAH

IPO

Initial public offering

IRS

Internal Revenue Service

JOBS Act

Jumpstart Our Business Startups Act of 2012Investigator-Sponsored Trial

KKC

 

Kyowa Kirin Co., Ltd. (formerly KHK or Kyowa Hakko Kirin Co., Ltd.)

mFARS

 

Modified Friedreich’s Ataxia Rating Scale

NDA

 

New Drug Application

PAHNYU

 

Pulmonary arterial hypertensionNew York University Grossman School of Medicine

Retained eGFRPDUFA

 

eGFR change after a four-week withdrawal of drugPrescription Drug User Fee Act

SAERegistrational trial

 

Serious adverse eventAn adequate and well-controlled trial designed to be sufficient to apply for regulatory

approval of a drug candidate, although notwithstanding the Company’s design a

regulatory agency may determine that further clinical studies or data are required

Sarbanes-Oxley Act

 

The Sarbanes-Oxley Act of 2002

SEC

 

U.S. Securities and Exchange Commission

T1D CKD

 

Type 1 diabetic CKD

T2D CKD

 

Type 2 diabetic CKD

 


PART I - FINANCIAL INFORMATION

 

 

Item 1. Financial Statements.

Reata Pharmaceuticals, Inc.

Consolidated Balance Sheets

(in thousands, except share data)

 

 

September 30, 2019

 

 

December 31, 2018

 

 

June 30, 2020

 

 

December 31, 2019

 

 

(unaudited)

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

240,149

 

 

$

337,790

 

 

$

610,419

 

 

$

664,324

 

Prepaid expenses and other current assets

 

 

6,382

 

 

 

4,483

 

 

 

7,830

 

 

 

4,952

 

Income tax receivable

 

 

22,218

 

 

 

 

Total current assets

 

 

246,531

 

 

 

342,273

 

 

 

640,467

 

 

 

669,276

 

Property and equipment, net

 

 

2,859

 

 

 

1,445

 

 

 

4,267

 

 

 

2,996

 

Other assets

 

 

9,733

 

 

 

1,490

 

 

 

7,670

 

 

 

10,148

 

Total assets

 

$

259,123

 

 

$

345,208

 

 

$

652,404

 

 

$

682,420

 

Liabilities and stockholders’ (deficit) equity

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Accounts payable

 

 

3,582

 

 

 

4,473

 

 

 

11,263

 

 

 

1,908

 

Accrued direct research liabilities

 

 

19,848

 

 

 

15,416

 

 

 

16,689

 

 

 

23,774

 

Other current liabilities

 

 

14,398

 

 

 

4,696

 

 

 

14,545

 

 

 

11,631

 

Current portion of long-term debt, net of debt issuance cost

 

 

5,313

 

 

 

 

Current portion of payable to collaborators

 

 

 

 

 

150,000

 

Current portion of deferred revenue

 

 

31,421

 

 

 

31,335

 

 

 

4,688

 

 

 

4,701

 

Total current liabilities

 

 

74,562

 

 

 

55,920

 

 

 

47,185

 

 

 

192,014

 

Other long-term liabilities

 

 

6,198

 

 

 

524

 

 

 

6,940

 

 

 

6,982

 

Long-term debt, net of current portion and debt issuance cost

 

 

74,923

 

 

 

79,219

 

Term loan, net of debt issuance costs

 

 

 

 

 

155,017

 

Liability related to sale of future royalties, net

 

 

294,234

 

 

 

 

Payable to collaborators, net of current portion

 

 

70,055

 

 

 

66,862

 

Deferred revenue, net of current portion

 

 

170,863

 

 

 

194,386

 

 

 

2,363

 

 

 

4,688

 

Total noncurrent liabilities

 

 

251,984

 

 

 

274,129

 

 

 

373,592

 

 

 

233,549

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ (deficit) equity:

 

 

 

 

 

 

 

 

Common stock A, $0.001 par value:

500,000,000 shares authorized; issued and outstanding – 24,525,768 and

24,000,683 at September 30, 2019 and December 31, 2018, respectively

 

 

25

 

 

 

24

 

Common stock B, $0.001 par value:

150,000,000 shares authorized; issued and outstanding – 5,598,731

and 5,728,175 shares at September 30, 2019 and December 31, 2018

 

 

6

 

 

 

6

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Common stock A, $0.001 par value:

500,000,000 shares authorized; issued and outstanding – 28,526,532 and

27,878,550 at June 30, 2020 and December 31, 2019, respectively

 

 

29

 

 

 

28

 

Common stock B, $0.001 par value:

150,000,000 shares authorized; issued and outstanding – 5,058,319 and

5,318,157 shares at June 30, 2020 and December 31, 2019, respectively

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

456,097

 

 

 

435,452

 

 

 

1,058,606

 

 

 

967,317

 

Accumulated deficit

 

 

(523,551

)

 

 

(420,323

)

 

 

(827,013

)

 

 

(710,493

)

Total stockholders’ (deficit) equity

 

 

(67,423

)

 

 

15,159

 

Total liabilities and stockholders’ (deficit) equity

 

$

259,123

 

 

$

345,208

 

Total stockholders’ equity

 

 

231,627

 

 

 

256,857

 

Total liabilities and stockholders’ equity

 

$

652,404

 

 

$

682,420

 

 

 

See accompanying notes.


Reata Pharmaceuticals, Inc.

Unaudited Consolidated Statements of Operations

(in thousands, except share and per share data)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

September 30,

 

 

September 30,

 

 

June 30

 

 

June 30

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Collaboration revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License and milestone

 

$

7,898

 

 

$

4,766

 

 

$

23,437

 

 

$

44,452

 

 

$

1,169

 

 

$

7,813

 

 

$

2,338

 

 

$

15,539

 

Other revenue

 

 

344

 

 

 

409

 

 

 

409

 

 

 

685

 

 

 

1,904

 

 

 

20

 

 

 

2,088

 

 

 

64

 

Total collaboration revenue

 

 

8,242

 

 

 

5,175

 

 

 

23,846

 

 

 

45,137

 

 

 

3,073

 

 

 

7,833

 

 

 

4,426

 

 

 

15,603

 

Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

32,279

 

 

 

27,144

 

 

 

87,948

 

 

 

71,979

 

 

 

36,783

 

 

 

29,554

 

 

 

84,436

 

 

 

55,668

 

General and administrative

 

 

14,283

 

 

 

7,486

 

 

 

36,027

 

 

 

24,802

 

 

 

16,600

 

 

 

11,706

 

 

 

37,387

 

 

 

21,744

 

Depreciation

 

 

258

 

 

 

105

 

 

 

659

 

 

 

311

 

 

 

284

 

 

 

232

 

 

 

562

 

 

 

401

 

Total expenses

 

 

46,820

 

 

 

34,735

 

 

 

124,634

 

 

 

97,092

 

 

 

53,667

 

 

 

41,492

 

 

 

122,385

 

 

 

77,813

 

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income

 

 

1,311

 

 

 

1,094

 

 

 

4,812

 

 

 

1,787

 

Interest expense

 

 

(2,389

)

 

 

(2,360

)

 

 

(7,199

)

 

 

(3,773

)

Loss on extinguishment of debt

 

 

 

 

 

 

 

 

 

 

 

(1,007

)

Other income (expense)

 

 

 

 

 

 

 

 

7

 

 

 

 

Total other income (expense)

 

 

(1,078

)

 

 

(1,266

)

 

 

(2,380

)

 

 

(2,993

)

Other income (expense), net

 

 

(16,990

)

 

 

(701

)

 

 

(20,804

)

 

 

(1,301

)

Loss before taxes on income

 

 

(39,656

)

 

 

(30,826

)

 

 

(103,168

)

 

 

(54,948

)

 

 

(67,584

)

 

 

(34,360

)

 

 

(138,763

)

 

 

(63,511

)

Provision for taxes on income

 

 

38

 

 

 

9

 

 

 

60

 

 

 

15

 

(Benefit from) provision for taxes on income

 

 

(3

)

 

 

20

 

 

 

(22,243

)

 

 

23

 

Net loss

 

$

(39,694

)

 

$

(30,835

)

 

$

(103,228

)

 

$

(54,963

)

 

$

(67,581

)

 

$

(34,380

)

 

$

(116,520

)

 

$

(63,534

)

Net loss per share—basic and diluted

 

$

(1.32

)

 

$

(1.07

)

 

$

(3.44

)

 

$

(2.03

)

 

$

(2.03

)

 

$

(1.14

)

 

$

(3.51

)

 

$

(2.12

)

Weighted-average number of common shares used in

net loss per share basic and diluted

 

 

30,110,391

 

 

 

28,704,853

 

 

 

30,004,211

 

 

 

27,022,269

 

 

 

33,265,778

 

 

 

30,069,048

 

 

 

33,243,931

 

 

 

29,950,241

 

 

 

See accompanying notes.


Reata Pharmaceuticals, Inc.

Unaudited Consolidated Statements of Stockholders’ Equity (Deficit) Equity

(in thousands, except share and per share data)

 

 

Three Months Ended September 30, 2019

 

 

Three Months Ended June 30, 2020

 

 

Common Stock A

 

 

Common Stock B

 

 

Additional

Paid-In

 

 

Shareholder

Notes

 

 

Total

Accumulated

 

 

Total

Stockholders’

 

 

Common Stock A

 

 

Common Stock B

 

 

Additional

Paid-In

 

 

Total

Accumulated

 

 

Total

Stockholders’

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Receivable

 

 

Deficit

 

 

(Deficit) Equity

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

Balance at June 30, 2019

 

 

24,466,407

 

 

$

24

 

 

 

5,631,527

 

 

$

6

 

 

$

450,354

 

 

$

 

 

$

(483,857

)

 

$

(33,473

)

Balance at March 31, 2020

 

 

28,166,652

 

 

$

28

 

 

 

5,070,271

 

 

$

5

 

 

$

988,046

 

 

$

(759,432

)

 

$

228,647

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(39,694

)

 

 

(39,694

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(67,581

)

 

 

(67,581

)

Compensation expense

related to stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,380

 

 

 

 

 

 

 

 

 

5,380

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14,796

 

 

 

 

 

 

14,796

 

Exercise of options

 

 

 

 

 

 

 

 

26,565

 

 

 

 

 

 

363

 

 

 

 

 

 

 

 

 

363

 

 

 

 

 

 

 

 

 

7,135

 

 

 

 

 

 

365

 

 

 

 

 

 

365

 

Conversion of common stock

Class B to Class A

 

 

59,361

 

 

 

1

 

 

 

(59,361

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

19,087

 

 

 

 

 

 

(19,087

)

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2019

 

 

24,525,768

 

 

$

25

 

 

 

5,598,731

 

 

$

6

 

 

$

456,097

 

 

$

 

 

$

(523,551

)

 

$

(67,423

)

Issuance of Common Stock

 

 

340,793

 

 

 

1

 

 

 

 

 

 

 

 

 

55,399

 

 

 

 

 

 

55,400

 

Balance at June 30, 2020

 

 

28,526,532

 

 

$

29

 

 

 

5,058,319

 

 

$

5

 

 

$

1,058,606

 

 

$

(827,013

)

 

$

231,627

 

 

 

Nine Months Ended September 30, 2019

 

 

Six Months Ended June 30, 2020

 

 

Common Stock A

 

 

Common Stock B

 

 

Additional

Paid-In

 

 

Shareholder

Notes

 

 

Total

Accumulated

 

 

Total

Stockholders’

 

 

Common Stock A

 

 

Common Stock B

 

 

Additional

Paid-In

 

 

Total

Accumulated

 

 

Total

Stockholders’

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Receivable

 

 

Deficit

 

 

(Deficit) Equity

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2018

 

 

24,000,683

 

 

$

24

 

 

 

5,728,175

 

 

$

6

 

 

$

435,452

 

 

$

 

 

$

(420,323

)

 

$

15,159

 

Balance at December 31, 2019

 

 

27,878,550

 

 

$

28

 

 

 

5,318,157

 

 

$

5

 

 

$

967,317

 

 

$

(710,493

)

 

$

256,857

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

$

 

 

 

 

 

 

(103,228

)

 

 

(103,228

)

 

 

 

 

 

 

 

 

 

 

 

 

 

$

 

 

 

(116,520

)

 

 

(116,520

)

Compensation expense

related to stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

$

14,090

 

 

 

 

 

 

 

 

 

14,090

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$

34,104

 

 

 

 

 

 

34,104

 

Exercise of options

 

 

 

 

 

 

 

 

395,641

 

 

 

 

 

$

6,448

 

 

 

 

 

 

 

 

 

6,448

 

 

 

 

 

 

 

 

 

47,351

 

 

 

 

 

$

1,786

 

 

 

 

 

 

1,786

 

Conversion of common stock

Class B to Class A

 

 

525,085

 

 

 

1

 

 

 

(525,085

)

 

 

 

 

$

 

 

 

 

 

 

 

 

 

1

 

 

 

307,189

 

 

 

 

 

 

(307,189

)

 

 

 

 

$

 

 

 

 

 

 

 

Other shareholder

transactions

 

 

 

 

 

 

 

 

 

 

 

 

 

$

107

 

 

 

 

 

 

 

 

 

107

 

Balance at September 30, 2019

 

 

24,525,768

 

 

$

25

 

 

 

5,598,731

 

 

$

6

 

 

$

456,097

 

 

$

 

 

$

(523,551

)

 

$

(67,423

)

Issuance of Common Stock

 

 

340,793

 

 

 

1

 

 

 

 

 

 

 

 

$

55,399

 

 

 

 

 

 

55,400

 

Balance at June 30, 2020

 

 

28,526,532

 

 

$

29

 

 

 

5,058,319

 

 

$

5

 

 

$

1,058,606

 

 

$

(827,013

)

 

$

231,627

 

 

 

Three Months Ended June 30, 2019

 

 

 

Common Stock A

 

 

Common Stock B

 

 

Additional

Paid-In

 

 

Total

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

(Deficit)

 

Balance at March 31, 2019

 

 

24,403,477

 

 

$

24

 

 

 

5,639,666

 

 

$

6

 

 

$

444,837

 

 

$

(449,477

)

 

$

(4,610

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,380

)

 

 

(34,380

)

Compensation expense

   related to stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,483

 

 

 

 

 

 

4,483

 

Exercise of options

 

 

 

 

 

 

 

 

54,791

 

 

 

 

 

 

1,034

 

 

 

 

 

 

1,034

 

Conversion of common stock

   Class B to Class A

 

 

62,930

 

 

 

 

 

 

(62,930

)

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2019

 

 

24,466,407

 

 

$

24

 

 

 

5,631,527

 

 

$

6

 

 

$

450,354

 

 

$

(483,857

)

 

$

(33,473

)

 

 

Three Months Ended September 30, 2018

 

 

Six Months Ended June 30, 2019

 

 

Common Stock A

 

 

Common Stock B

 

 

Additional

Paid-In

 

 

Shareholder

Notes

 

 

Total

Accumulated

 

 

Total

Stockholders’

 

 

Common Stock A

 

 

Common Stock B

 

 

Additional

Paid-In

 

 

Total

Accumulated

 

 

Total

Stockholders’

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Receivable

 

 

Deficit

 

 

(Deficit) Equity

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity (Deficit)

 

Balance at June 30, 2018

 

 

20,244,675

 

 

$

20

 

 

 

5,961,183

 

 

$

6

 

 

$

196,013

 

 

$

 

 

$

(363,913

)

 

$

(167,874

)

Balance at December 31, 2018

 

 

24,000,683

 

 

$

24

 

 

 

5,728,175

 

 

$

6

 

 

$

435,452

 

 

$

(420,323

)

 

$

15,159

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(30,835

)

 

 

(30,835

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(63,534

)

 

 

(63,534

)

Compensation expense

related to stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,745

 

 

 

 

 

 

(10

)

 

 

2,735

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,710

 

 

 

 

 

 

8,710

 

Exercise of options

 

 

 

 

 

 

 

 

41,672

 

 

 

 

 

 

672

 

 

 

 

 

 

 

 

 

672

 

 

 

 

 

 

 

 

 

369,076

 

 

 

 

 

 

6,085

 

 

 

 

 

 

6,085

 

Public offering of common stock, net of offering costs

 

 

3,450,000

 

 

 

4

 

 

 

 

 

 

 

 

 

232,843

 

 

 

 

 

 

 

 

 

232,847

 

Conversion of common stock

Class B to Class A

 

 

189,290

 

 

 

 

 

 

(189,290

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

465,724

 

 

 

 

 

 

(465,724

)

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2018

 

 

23,883,965

 

 

$

24

 

 

 

5,813,565

 

 

$

6

 

 

$

432,273

 

 

$

 

 

$

(394,758

)

 

$

37,545

 

Other shareholder

transactions

 

 

 

 

 

 

 

 

 

 

 

 

 

 

107

 

 

 

 

 

 

107

 

Balance at June 30, 2019

 

 

24,466,407

 

 

$

24

 

 

 

5,631,527

 

 

$

6

 

 

$

450,354

 

 

$

(483,857

)

 

$

(33,473

)

 

 

 

Nine Months Ended September 30, 2018

 

 

 

Common Stock A

 

 

Common Stock B

 

 

Additional

Paid-In

 

 

Shareholder

Notes

 

 

Total

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Receivable

 

 

Deficit

 

 

(Deficit) Equity

 

Balance at December 31, 2017

 

 

19,975,340

 

 

$

20

 

 

 

6,166,166

 

 

$

7

 

 

$

190,145

 

 

$

(2

)

 

$

(337,143

)

 

$

(146,973

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(54,963

)

 

 

(54,963

)

Compensation expense

   related to stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,781

 

 

 

 

 

 

(18

)

 

 

7,763

 

Exercise of options

 

 

 

 

 

 

 

 

106,024

 

 

 

 

 

 

1,498

 

 

 

 

 

 

 

 

 

1,498

 

Proceeds from payments of

   shareholder promissory

    notes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6

 

 

 

2

 

 

 

 

 

 

8

 

Public offering of common stock, net of offering costs

 

 

3,450,000

 

 

 

4

 

 

 

 

 

 

 

 

 

232,843

 

 

 

 

 

 

 

 

 

232,847

 

Conversion of common stock

   Class B to Class A

 

 

458,625

 

 

 

 

 

 

(458,625

)

 

 

(1

)

 

 

 

 

 

 

 

 

 

 

 

(1

)

Adoption of new accounting

   guidance

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,634

)

 

 

(2,634

)

Balance at September 30, 2018

 

 

23,883,965

 

 

$

24

 

 

 

5,813,565

 

 

$

6

 

 

$

432,273

 

 

$

 

 

$

(394,758

)

 

$

37,545

 

 

See accompanying notes.


Reata Pharmaceuticals, Inc.

Unaudited Consolidated Statements of Cash Flows

(in thousands)

 

 

Nine Months Ended

 

 

Six Months Ended

 

 

September 30,

 

 

June 30

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

Operating activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(103,228

)

 

$

(54,963

)

 

$

(116,520

)

 

$

(63,534

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation

 

 

659

 

 

 

311

 

 

 

562

 

 

 

401

 

Amortization of debt issuance costs

 

 

1,017

 

 

 

549

 

Amortization of debt issuance costs and implied interest

 

 

4,163

 

 

 

678

 

Non-cash interest expense on liability related to sale of future royalty

 

 

664

 

 

 

 

Stock-based compensation expense

 

 

14,090

 

 

 

7,783

 

 

 

34,104

 

 

 

8,710

 

Loss on extinguishment of debt

 

 

 

 

 

1,007

 

 

 

11,183

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(1,899

)

 

 

(1,304

)

Other assets

 

 

20

 

 

 

14

 

Income tax receivable

 

 

(22,218

)

 

 

 

Prepaid expenses and other current assets and other assets

 

 

(1,815

)

 

 

(2,271

)

Accounts payable

 

 

(440

)

 

 

2,933

 

 

 

9,355

 

 

 

312

 

Accrued direct research and other current and long-term liabilities

 

 

11,442

 

 

 

10,836

 

Accrued direct research, other current, and long-term liabilities

 

 

(4,247

)

 

 

9,802

 

Payable to collaborators

 

 

(150,000

)

 

 

 

Deferred revenue

 

 

(23,437

)

 

 

(13,452

)

 

 

(2,338

)

 

 

(15,539

)

Net cash used in operating activities

 

 

(101,776

)

 

 

(46,286

)

 

 

(237,107

)

 

 

(61,441

)

Investing activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(2,420

)

 

 

(370

)

 

 

(384

)

 

 

(2,092

)

Net cash used in investing activities

 

 

(2,420

)

 

 

(370

)

 

 

(384

)

 

 

(2,092

)

Financing activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock

 

 

 

 

 

232,846

 

Proceeds from long-term debt

 

 

 

 

 

60,000

 

Payments on deferred issuance costs

 

 

 

 

 

(2,289

)

Proceeds from issuance of common stock, net

 

 

55,399

 

 

 

 

Payments on long-term debt

 

 

(167,170

)

 

 

 

Exercise of options

 

 

6,448

 

 

 

1,504

 

 

 

1,786

 

 

 

6,085

 

Other shareholder transactions

 

 

107

 

 

 

 

Proceeds from sale of future royalties, net

 

 

293,571

 

 

 

107

 

Net cash provided by financing activities

 

 

6,555

 

 

 

292,061

 

 

 

183,586

 

 

 

6,192

 

Net (decrease) increase in cash and cash equivalents

 

 

(97,641

)

 

 

245,405

 

Net decrease in cash and cash equivalents

 

 

(53,905

)

 

 

(57,341

)

Cash and cash equivalents at beginning of year

 

 

337,790

 

 

 

129,780

 

 

 

664,324

 

 

 

337,790

 

Cash and cash equivalents at end of period

 

$

240,149

 

 

$

375,185

 

 

$

610,419

 

 

$

280,449

 

Supplemental disclosures

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

6,226

 

 

$

2,715

 

 

$

8,021

 

 

$

4,153

 

Purchases of equipment in accounts payable and other current liabilities

 

$

145

 

 

$

31

 

Accrued deferred offering cost

 

$

 

 

$

22

 

Non-cash activity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Right-of-use assets obtained in exchange for lease obligations

 

$

8,262

 

 

$

 

 

$

 

 

$

8,981

 

Purchases of equipment in accounts payable, accrued direct research, other current, and long-term liabilities

 

$

1,448

 

 

$

170

 

 

See accompanying notes.

 


Reata Pharmaceuticals, Inc.

Notes to Unaudited Consolidated Financial Statements

 

 

1. Description of Business

The Company’s mission is to identify, develop, and commercialize innovative therapies that change patients’ lives for the better.  The Company focuses on small-molecule therapeutics with novel mechanisms of action for the treatment of severe, life-threatening diseases with few or no approved therapies.  The Company’s lead programs are in rare forms of chronic kidney disease (CKD) and a rare formsneurological disease.  The Company announced positive topline data from registrational trials for both of neurological diseases.  The Company’sits lead product candidates, bardoxolone methyl (bardoxolone) in patients with CKD caused by Alport syndrome, and omaveloxolone in patients with a neurological diseases,disorder called Friedreich’s ataxia (FA).  Both bardoxolone and omaveloxolone activate the transcription factor Nrf2 to normalize mitochondrial function, restore redox balance, and resolve inflammation.  Because mitochondrial dysfunction, oxidative stress, and inflammation are features of many diseases, the Company believes bardoxolone and omaveloxolone have many potential clinical applications.

The Company has reported top-line efficacy  Reata possesses exclusive, worldwide rights to develop, manufacture and safety Year 1 results from its registrational CARDINAL Phase 3 clinical trial ofcommercialize bardoxolone, omaveloxolone, and our next-generation Nrf2 activators, excluding certain Asian markets for bardoxolone in CKD caused by Alport syndrome.  Alport syndrome is a rare and serious hereditary disease with no approved therapy.  The trial met its primary and key secondary Year 1 endpoints.  CARDINAL demonstrated a statistically significant change in the estimated glomerular filtration rate (eGFR) relativecertain indications, which are licensed to placebo after 48 weeks of treatment and in retained eGFR, which is the change in eGFR after 48 weeks of treatment and a four-week withdrawal period. Subject to discussions with regulatory authorities, the Company plans to proceed with the submission of regulatory filings for marketing approval in the United States and internationally.

The Company has reported top-line efficacy and safety results from its registrational part 2 portion of the MOXIe Phase 2 trial of omaveloxolone in Friedreich’s ataxia (FA).  FA is a rare, inherited, debilitating, and degenerative neuromuscular disorder with no approved therapy.  The trial demonstrated statistically significant evidence of efficacy for its primary endpoint of change in the modified Friedreich’s Ataxia Rating Scale (mFARS) relative to placebo after 48 weeks of treatment. Subject to discussions with regulatory authorities, the Company plans to proceed with the submission of regulatory filings for marketing approval in the United States and internationally.

The Company is also conducting two additional registrational trials:  FALCON, studying bardoxolone in patients with autosomal dominant polycystic kidney disease (ADPKD)Kyowa Kirin Co., and CATALYST, studying bardoxolone in patients with a rare and serious form of pulmonary arterial hypertension (PAH) caused by connective tissue disease (CTD-PAH)Ltd. (KKC).  The Company initiated enrollment of FALCON in May 2019, and the Company expects to have top-line data from CATALYST in mid-2020.

The Company’s consolidated financial statements include the accounts of all majority-owned subsidiaries.  Accordingly, the Company’s share of net earnings and losses from these subsidiaries is included in the consolidated statements of operations.  Intercompany profits, transactions, and balances have been eliminated in consolidation.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.  Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements.  In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included.  Operating results for the ninesix months ended SeptemberJune 30, 20192020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019.2020.  The consolidated balance sheet at December 31, 2018,2019, has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements.  For further information, refer to the annual consolidated financial statements and footnotes thereto of the Company.

Summary of Significant Accounting Policies

The Company’s significant accounting policies used in preparation of these condensed consolidated financial statements for the three and six months ended June 30, 2020 are describedconsistent with those discussed in Note 2 of Notes to Consolidated Financial Statements includedthe consolidated financial statements in itsthe Company’s Annual Report on Form 10-K for the year ended December 31, 2018 (2018 Annual Report2019, except as noted below with respect to the Company’s liability related to sale of future royalties and as noted within the “Recent Accounting Pronouncements – Recently Adopted Accounting Pronouncements” section.

Liability Related to Sale of Future Royalties

On June 10, 2020, the Company entered into a Development and Commercialization Funding Agreement with an affiliate of Blackstone Life Sciences, LLC (BXLS) that provides funding for the development and commercialization of bardoxolone for the treatment of CKD caused by Alport syndrome, autosomal dominant polycystic kidney disease (ADPKD), and certain other rare CKD indications in return for future royalties (Development Agreement).  The Company accounted for the Development Agreement as a sale of future revenues resulting in a debt classification, primarily because the Company has significant continuing involvement in generating the future revenue on which the royalties are based. The debt will be amortized under the effective interest rate method and, accordingly, the Company is recognizing non-cash interest expense over the estimated term of the Development Agreement. The liability related to sale of future royalties, and the debt amortization, are based


on Form 10-K).  During the first quarterCompany’s current estimate of 2019,future royalties expected to be paid over the Company adopted Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842). As a resultestimated term of the adoption of Topic 842,Development Agreement. The Company will periodically assess the Company has updatedexpected royalty payments and, if materially different than its Leases accounting policies.previous estimate, will prospectively adjust and recognize the related non-cash interest expense. There were no other changesThe transaction costs associated with the liability will be amortized to its significant accounting policies from those disclosednon-cash interest expense over the estimated term of the Development Agreement. See Note 5, Liability Related to Sale of Future Royalties, of Notes to Consolidated Financial Statements contained in its 2018 Annualthis Quarterly Report on Form 10-K.10-Q.

LiquidityFair Value Measurements

AsThe Company categorizes its financial instruments measured at fair value into a three-level fair value hierarchy that prioritizes the inputs used in determining the fair value of September 30, 2019, the Company had cash and cash equivalentsasset or liability. The three levels of $240,149,000. the fair value hierarchy are as follows:

Level 1 - Financial instruments that have values based on unadjusted quoted prices for identical assets or liabilities in an active market which the Company has the ability to access at the measurement date

Level 2 - Financial instruments that have values based on quoted market prices in markets where trading occurs infrequently or that have values based on quoted prices of instruments with similar attributes in active markets.

Level 3 - Financial instruments that have values based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. These inputs reflect management’s own assumptions about the assumptions a market participant would use in pricing the asset.

The Company has experienced losses and negative operating cash flows for many years since inception and has no marketed drug or other products. The Company’s abilitydetermined the fair value of the liability related to generatethe sale of future revenue depends upon the results of its development programs, the success of which cannot be guaranteed.

The Company expects its current cash and its access to additional equity or debt funding will enable it to meet its current obligations through December 31, 2020. See Note 9, Subsequent Events.

Leases

At the inception of an arrangement, the Company determines if an arrangementroyalties is or contains, a lease based on the unique facts and circumstances present in that arrangement. Lease assets represent the Company’s rightcurrent estimates of future royalties expected to use an underlying asset for the lease term, and lease liabilities represent the obligationbe paid to make lease payments arising from the lease. These assets and liabilities are initially recognized at the lease commencement date based on the present value of lease paymentsBXLS, over the lease term calculated using its incremental borrowing rate based on the information available at commencement unless the implicit rate is readily determinable.  Lease assets also include upfront lease payments, lease incentives paid, and direct costs incurred and exclude lease incentives received.  The lease term used to calculate the lease assets and related lease liabilities includes the options to extend or terminate the lease when it is reasonably certain that the Company will exercise those options. Lease expense for operating leases is recognized on a straight-line basis over the expected lease term as an operating expense while the expense for finance leases is recognized as depreciation expense over the expected lease term unless there is a transfer of title or purchase option reasonably certain of exercise.

The Company will account for each lease component separately from the nonlease components.  The depreciable life of lease assets and leasehold improvements is limited by the expected lease term unless there is a transferarrangement, which are considered Level 3. See Note 5, Liability Related to Sale of title or purchase option reasonably certainFuture Royalties, of its exercise.

Leases with an initial term of 12 months or less are not recordedNotes to Consolidated Financial Statements contained in this Quarterly Report on the balance sheet, and the expenses for these short-term leases and operating leases are recognized on a straight-line basis over the lease term.Form 10-Q.

Recently Adopted Accounting Pronouncements

The Company is an emerging growth company (EGC), as defined in the JOBS Act.  Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies.  The Company has irrevocably elected not to avail itself of this exemption from new or revised accounting standards, and, therefore, will be subject to the same new or revised accounting standards as public companies that are not emerging growth companies.  The Company will remain an EGC until December 31, 2019.

In February 2016, the Financial Accounting Standards Board (FASB) issued Topic 842, amended by ASU 2018-11, Leases (Topic 842): Targeted Improvements.Improvements. The new guidance requires a lessee to recognize assets and liabilities for all leases with lease terms of more than 12 months and provide additional disclosures. Topic 842 requires adoption using a modified retrospective transition approach with either 1) transition provisions at the beginning of the earliest comparative period recordswith its cumulative adjustment recognized to retained earnings at the beginning of the earliest period presented or 2) a cumulative-effect adjustment recognized to the opening balance of retained earnings on the adoption.  We adopted this standard on January 1, 2019, using the cumulative-effect adjustment approach. We elected the package of practical expedients in transition for leases that commenced prior to January 1, 2019 whereby these contracts were not reassessed or reclassified from their previous assessment as of December 31, 2018.

As a result of implementing Topic 842, the Company recognized an operating lease right-of-use asset of $1,544,000 and an operating lease liability of $1,659,000 on January 1, 2019, with no impact on its beginning retained earnings, consolidated statements of operations, or cash flows.  See Note 5, Leases, for further details.


In July 2018, the FASB issued ASU No. 2018-09, Codification Improvements (ASU 2018-09).  This ASU provided various minor codification updates and improvements to address comments that the FASB had received regarding unclear or vague accounting guidance.  The guidance is effective for fiscal years beginning after December 15, 2018, including interim reporting periods within that fiscal year.  The adoption of this guidance did not have a material impact on our financial position, results of operations or disclosures.

In July 2019, the FASB issued ASU No. 2019-07, Codification Updates to SEC Sections. The ASU clarifies or improves the disclosure and presentation requirements of a variety of codification topics by aligning them with the SEC’s regulations, thereby eliminating redundancies and making the codification easier to apply.  The guidance is effective upon issuance. The adoption of this guidance did not have a significant impact on the Company’s reported consolidated financial results.

Recently Issued Accounting Pronouncements Not Yet Adopted

In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements(Topic (Topic 808) (ASU 2018-18).  This update provides clarification on the interaction between Revenue Recognitionfrom Contracts with Customers (Topic 606) and Collaborative Arrangements (Topic 808) including the alignment of unit of account guidance between the two topics.  This update is effective in fiscal years, including interim periods, beginning after December 15, 2020,2019, and early adoption is permitted.  The Company is evaluating theadopted this standard on January 1, 2020 and its adoption did not have a material impact on itsthe Company’s consolidated financial statements and related disclosure.

In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. This update requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to defer and recognize as an asset. This guidance should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoptingadoption. The Company adopted this guidance.standard on January 1, 2020 and its adoption did not have material impact to the Company’s consolidated financial statements and related disclosure.


3. Collaboration Agreements

AbbVie

In September 2010, the Company entered into a license agreement with AbbVie Inc. (AbbVie) (the AbbVie License Agreement) for an exclusive license to develop and commercialize bardoxolone in the Licensee Territory (as defined in the AbbVie License Agreement).

In December 2011, the Company entered into a collaboration agreement with AbbVie Inc. (AbbVie) (the AbbVie Collaboration Agreement) to jointly research, develop, and commercialize the Company’s portfolio of second and later generation oral Nrf2 activators.  The terms of the Collaboration Agreement include payment to the Company of a nonrefundable, up-front payment of $400,000,000. The Company is also participating with AbbVie on joint steering committees.  

The up-front payment and the Company’s collaboration on research, development, and commercialization are accounted for as a single unit of accounting.  Revenue is being recognized ratably through December 2026, which is the estimated minimum period that is needed to complete the performance obligations under the terms of the Collaboration Agreement.  The Company began recognizing revenue related to the up-front payment upon execution of the Collaboration Agreement. During the three months ended September 30, 2019 and 2018, the Company recognized approximately $6,717,000, and during the nine months ended September 30, 2019 and 2018, recognized $19,931,000, as collaboration revenue.  As of September 30, 2019, the Company recorded deferred revenue totaling approximately $191,714,000 of which approximately $26,720,000 is reflected as the current portion of deferred revenue.

On October 9, 2019, the Company and AbbVie entered into an Amended and Restated License Agreement (the Amended AbbVieReacquisition Agreement) pursuant to which the Company reacquired the development, manufacturing, and commercialization rights concerning its proprietary Nrf2 activator product platform originally licensed to AbbVie in the AbbVie License Agreement datedand the AbbVie Collaboration Agreement.  In exchange for such rights, the Company agreed to pay AbbVie $330.0 million, of which $100.0 million was paid as of September 21, 2010, whichDecember 31, 2019, $150.0 million was paid on June 30, 2020, and $80.0 million will be payable on November 30, 2021.  Additionally, the Company entered intowill pay AbbVie an escalating, low single-digit royalty on worldwide net sales, on a product-by-product basis, of omaveloxolone and certain next-generation Nrf2 activators. The Company recognized interest expense related to the Reacquisition Agreement of approximately $1.6 million and $0 million, during the three months ended June 30, 2020 and 2019, respectively, and $3.2 million and $0 million, during the six months ended June 30, 2020 and 2019, respectively.  As of June 30, 2020, the Company’s payable to collaborators was $80.0 million, with a present value of $70.1 million.  

The execution of the Reacquisition Agreement ended our performance obligations under the AbbVie (the License Agreement),Collaboration Agreement and included the write off of the remaining related deferred revenue balance, after which no further revenue was recognized.  Accordingly, there was 0 revenue recognized in 2020.  The Company recognized revenue related to the AbbVie Collaboration Agreement. See Note 9, Subsequent Events.Agreement totaling approximately $6.6 million and $13.2 million during the three and six months ended June 30, 2019, respectively. The deferred revenue balance was $0 million as of June 30, 2020.

KKC

In December 2009, the Company entered ainto an exclusive license agreement with Kyowa Kirin Co., Ltd. (KKC)KKC (the KKC Agreement), which granted KKC an exclusive license to develop and commercialize bardoxolone in the licensed territory.  The Company received a nonrefundable, up-front license fee of $35,000,000$35.0 million in 2009 and regulatory milestones totaling $45,000,000$45.0 million in 2010, 2012, and 2018 and could receive additional regulatory milestones of $52,000,000$52.0 million and commercial milestones of $140,000,000,$140.0 million, as well as tiered royalties ranging from the low teens to the low 20 percent range, depending on the country of sale and the amount of annual net sales, on net sales by KKC in the licensed territory.  

The up-front payment and regulatory milestones are accounted for as a single unit of accounting.  Revenue is being recognized ratably through December 2021, which is the estimated minimum period that is needed to


complete the deliverables under the terms of the KKC Agreement.  The Company began recognizing revenue related to the up-front payment upon execution of the KKC Agreement. DuringThe Company recognized collaboration revenue totaling approximately $1.2 million during each of the three months ended SeptemberJune 30, 2020 and 2019 and 2018,$2.3 million during each of the Company recognized approximately $1,181,000 and $(2,951,000), respectively, and during the ninesix months ended SeptemberJune 30, 20192020 and 2018, recognized $3,506,000 and $23,521,000, respectively, as collaboration revenue.2019.  As of SeptemberJune 30, 2019,2020, the Company recorded deferred revenue totaling approximately $10,570,000$7.1 million of which approximately $4,701,000$4.7 million is reflected as the current portion of deferred revenue.

4. Term Loan

On June 14, 2018, the Company entered into an Amended and Restated Loan and Security Agreement (the Restated Loan Agreement) with Oxford Finance LLC and Silicon Valley Bank (collectively, the Lenders), which amended and restated the Loan and Security Agreement entered into among Reata and the Lenders on March 31, 2017, as amended on November 3, 2017 (the Loan Agreement).

Under the Restated Loan Agreement, the Term A Loan was increased to $80,000,000, and the Term B Loan availability was increased to $45,000,000, available to be drawn within 30 days, but no later than December 31, 2019, after the achievement of one of two milestones.  If the Company is entitled to draw the Term B Loan but does not draw the Term B Loan by December 31, 2019, the Company is obligated to pay a non-utilization fee of $450,000.

All outstanding Term Loans will mature on June 1, 2023.  Under the Term A Loan, the Company will make interest-only payments for 24 months through June 1, 2020; however, if the Company draws the Term B Loan, the Company will make interest-only payments for 36 months through June 1, 2021.  The interest-only payment period will be followed by 36 equal monthly payments, or 24 equal monthly payments if the Company draws the Term B Loan, of principal and interest payments. The Term Loans will bear interest at a floating per annum rate calculated as 7.79% plus the greater of the 30-day U.S. Dollar LIBOR rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue or 1.91%, with a minimum rate of 9.7% and maximum rate of 12.29%.

The Company has the option to prepay all, but not less than all, of the borrowed amounts, provided that the Company will be obligated to pay a prepayment fee equal to (a) the aggregate amount of interest that the Company would have paid through the maturity date if prepayment is made on or before the first anniversary of the applicable funding date of the Term Loan, (b) 4.0% of the outstanding principal balance of the applicable Term Loan if prepayment is made after the first anniversary date and on or before the second anniversary of the applicable funding date, (c) 3.0% of the outstanding principal balance of the applicable Term Loan if prepayment is made after the second anniversary date and on or before the third anniversary of the applicable funding date, or (d) 1.5% of the outstanding principal balance of the applicable Term Loan if prepayment is made after the third anniversary date and on or before the fourth anniversary of the applicable funding date.  The Company will also be required to make a final exit fee payment of 6.5% of the principal balance of the Term A Loan and 4.0% of the Term B Loan, payable on the earliest of the prepayment of the Term Loans, acceleration of any Term Loan, or at maturity of the Term Loans.  As of September 30, 2019, the Term A Loan has an effective interest rate of 10.71% before debt issuance costs and final exit fee and 13.26% including debt issuance costs and final exit fee.  The Company was in compliance with all covenants under the Restated Loan Agreement as of September 30, 2019.

The Company may use the proceeds from the Term Loans for working capital and to fund its general business requirements.  The Company’s obligations under the Restated Loan Agreement are secured by substantially all of its current and future assets, including its owned intellectual property.


Term A Loan and unamortized issuance cost balance are as follows:

 

 

As of September 30, 2019

 

As of December 31, 2018

 

 

 

(in thousands)

 

Current portion of long-term debt1

 

$

6,667

 

$

 

Less current portion of unamortized issuance cost

 

 

1,354

 

 

 

Total current portion of long-term debt, net of debt issuance cost

 

 

5,313

 

 

 

 

 

 

 

 

 

 

 

Principal Amount

 

 

80,000

 

 

80,000

 

Exit Fee

 

 

5,200

 

 

5,200

 

Less long-term unamortized issuance cost

 

 

3,610

 

 

5,981

 

Less current portion of long-term debt

 

 

6,667

 

$

 

Total long-term debt, net of current portion and debt issuance cost

 

$

74,923

 

$

79,219

 

1 Current portion of principal payments reflects the interest-only payment period under the Term A Loan. If the Company draws the Term B Loan, the interest-only period will extend through June 1, 2021, and the current portion will be $0 until July 1, 2020.

 

The future principal payments by fiscal year for the Company’s Term A Loan:

 

 

As of September 30, 2019

 

 

 

(in thousands)

 

2019 (remaining three months)

 

$

 

2020

 

 

15,555

 

2021

 

 

26,667

 

2022

 

 

26,667

 

2023

 

 

11,111

 

 

 

$

80,000

 

On October 9, 2019, the Company entered into the First Amendment to the Amended and Restated Loan and Security Agreement (the Amendment)Amended Restated Loan Agreement).  Under the Amended Restated Loan Agreement, the Term A Loan principal amount was $80.0 million, and the Term B Loan availability was increased from $45.0 million to $75.0 million (collectively with the Lenders,Term A Loan, the Term Loans).  On December 20, 2019, the Company borrowed $75.0 million under the Term B Loan resulting in a principal balance of the Term Loans of $155.0 million.


On June 24, 2020, the Company paid off the total outstanding balance of the Term Loans prior to the maturity date.  The payoff consisted of (i) the outstanding principal balance of $155.0 million, (ii) exit fees of $6.7 million, which amendedhas been partially accrued up to the date of repayment, (iii) prepayment fees of $5.4 million, and (iv) accrued and unpaid interest of $1.0 million. At the time of payoff, all liabilities and obligations under the Amended Restated Loan Agreement were terminated. In connection with the payoff of the Term Loans, the Company recorded a loss on extinguishment of debt of $11.2 million in the three and six months ended June 30, 2020.

5. Liability Related to Sale of Future Royalties

On June 24, 2020, the Company closed on the Development Agreement with BXLS.  The Development Agreement includes a $300.0 million payment by an affiliate of BXLS in return for various percentage royalty payments on worldwide net sales of bardoxolone, once approved in the United States or certain specified European countries, by Reata and its licensees, other than KKC.  The royalty percentage will initially be in the mid-single digits and, in future years, can vary between higher-mid single digit percentages to low-single digit percentages depending on various milestones, including indication approval dates, cumulative royalty payments, and cumulative net sales.  Pursuant to the Development Agreement, we have granted BXLS a security interest in substantially all of our assets.

In addition, concurrent with the Development Agreement, the Company entered into a common stock purchase agreement (Purchase Agreement) with affiliates of BXLS to sell an aggregate of 340,793 shares of the Company’s Class A common stock at $146.72 per share for a total of $50.0 million.

The Company concluded that there were 2 units of accounting for the consideration received, comprised of the liability related to the sale of future royalties and the common shares.  The Company allocated the $300.0 million from the Development Agreement and $50.0 million from the Purchase Agreement between the two units of accounting on a relative fair value basis at the time of the transaction. The Company allocated $294.2 million, which includes $0.8 million in transaction costs incurred, in transaction consideration to the liability, and $55.5 million to the common shares.  The Company determined the fair value of the common shares based on the closing stock price on the June 24, 2020, the closing date of the Development Agreement. See Note 9, Subsequent EventsThe effective interest rate under the Development Agreement, including transaction costs, is approximately 13.7%.

5.The following table shows the activity within the liability related to sale of future royalties for the six months ended June 30, 2020:

 

 

Liability Related to Sale of Future Royalties

 

 

 

(in thousands)

 

Transaction date balance

 

$

294,454

 

Non-cash interest expense recognized, net of transaction cost amortization

 

 

664

 

Balance at June 30, 2020

 

 

295,118

 

Less: Unamortized transaction cost

 

 

(884

)

Carrying value at June 30, 2020

 

$

294,234

 

6. Other Income (Expense), Net

 

 

Three Months Ended

 

 

Six Months Ended

 

 

June 30

 

 

June 30

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

Other income (expense), net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income

 

$

501

 

 

$

1,705

 

 

$

2,555

 

 

$

3,502

 

 

Interest expense

 

 

(5,644

)

 

 

(2,413

)

 

 

(11,512

)

 

 

(4,810

)

 

Non-cash interest expense on liability

   related to sale of future royalty

 

 

(664

)

 

 

 

 

 

(664

)

 

 

 

 

Other income (expense)

 

 

 

 

 

7

 

 

 

 

 

 

7

 

 

Loss on extinguishment of debt

 

 

(11,183

)

 

 

 

 

 

(11,183

)

 

 

 

 

Total other income (expense), net

 

$

(16,990

)

 

$

(701

)

 

$

(20,804

)

 

$

(1,301

)

 


Investment Income

Interest income consists primarily of interest generated from our cash and cash equivalents.

Interest Expense

Interest expense consists primarily of interest on our borrowing activities under our loan agreements and the imputed interest from amount due to AbbVie under the Reacquisition Agreement.

Non-Cash Interest Expense on Liability Related to Sale of Future Royalties

Non-cash interest expense consists of recognition of interest expense based on the Company’s current estimate of future royalties expensed to be paid over the estimated term of the Development Agreement.

Other Income (Expense)

Other income (expense) consists primarily of gains and losses on foreign currency exchange and sales of assets.

Loss on Extinguishment of Debt

In June 2020, the Company paid off the Term Loans and recorded a loss on the extinguishment of debt of $11.2 million, which consisted primarily of prepayment fees, exit fees and unamortized debt issuance costs.

7. Leases

 

The Company has officesCompany’s headquarters are located in Irving, Texas, where it leases approximately 34,890 square feet of office and laboratory space, and in Plano, Texas, where it leases approximately 122,000 square feet of office space.  The Company leases additional office and laboratory space of approximately 34,890 square feet located in Irving, Texas. The lease terms for the Irving and Plano offices extend through October 31, 2022 with an option to renew up to six months and through April 30, 2022 with four successive three-month-period renewal options, respectively.  

The Company has an additional lease of a single-tenant, build-to-suit building of approximately 327,400 square feet of office and laboratory space located in Plano, Texas with an initial lease term of 16 years.  The Company entered into the lease agreement on October 15, 2019 (the Lease Agreement), and at the Company’s leasesoption, it may renew the lease for two consecutive five-year renewal periods or one ten-year renewal period.  The Company does not have remaining contractual termscontrol of the space or the construction prior to completion of construction.  Therefore, 0 right-of-use or lease liabilities were recorded in connection with the Lease Agreement as of June 30, 2020.  Under the First Amendment to the Lease Agreement executed in May 2020, the landlord will fund the Company’s leasehold improvements up to $31.3 million, of which the Company has recorded a leasehold incentive obligation of approximately 33 months, which includes the options to extend the leases for up to one year.  Our lease agreements do not contain any material residual value guarantees or material restrictive covenants.$1.7 million as other long-term liabilities as of June 30, 2020.

At SeptemberJune 30, 2019,2020, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases held by the Company were 8.3%9.6% and 2.52.3 years, respectively.  During the ninethree and six months ended SeptemberJune 30, 2019,2020, cash paid for amounts included for the measurement of lease liabilities was $1,667,000.$1.0 million and $1.9 million, respectively. During the three and ninesix months ended SeptemberJune 30, 20192020 the Company recorded operating lease expense of $911,000$1.0 million and $2,489,000,$1.9 million, respectively.  The Company has elected to net the amortization of the right-of-use assets and the reduction of the lease liabilities principal in accrued direct research and other current and long-term liabilities in the consolidated statements of cash flows.

Supplemental balance sheet information related to the Company’s operating leases is as follows:

 

 

Balance Sheet Classification

 

As of September 30, 2019

 

 

Balance Sheet Classification

 

As of June 30, 2020

 

 

 

 

(in thousands)

 

 

 

 

(in thousands)

 

Non-current right-of-use assets

 

Other assets

 

$

8,262

 

 

Other assets

 

$

7,653

 

Current lease liabilities

 

Other current liabilities

 

 

2,941

 

 

Other current liabilities

 

 

3,452

 

Non-current lease liabilities

 

Other long-term liabilities

 

 

6,198

 

 

Other long-term liabilities

 

 

5,212

 


 


Maturities of lease liabilities by fiscal year for the Company’s operating leases:

 

 

As of September 30, 2019

 

 

As of June 30, 2020

 

 

(in thousands)

 

 

(in thousands)

 

2019 (remaining three months)

 

$

718

 

2020

 

 

3,999

 

2020 (remaining six months)

 

$

2,063

 

2021

 

 

4,090

 

 

 

4,142

 

2022

 

 

1,178

 

 

 

3,500

 

Total lease payments

 

 

9,985

 

 

 

9,705

 

Less: Imputed interest

 

 

(846

)

 

 

(1,041

)

Present value of lease liabilities

 

$

9,139

 

 

$

8,664

 

 

8. Income Taxes

On October 15, 2019,March 27, 2020, the United States enacted the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act).  The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and to provide assistance to individuals, families, and businesses affected by COVID-19.  Accordingly, under its provisions, for the six months ended June 30, 2020, the Company entered intorecognized a lease agreement, relatingtax benefit and receivable of $22.1 million associated with the ability to carryback an applicable prior year’s net operating losses to a preceding year to generate a refund.

For the leasethree months ended June 30, 2020, the Company’s effective tax rate was a benefit of approximately 327,400 square feet of office and laboratory space located in Plano, Texas (Lease Agreement).  See Note 9, Subsequent Events.

6. Income Taxes

0.0% compared to 0.0% for the three months ended June 30, 2019.  The Company’s effective tax rate for the three months ended June 30, 2020 varies with the statutory rate primarily due to valuation allowances on deferred taxes.  For the six months ended June 30, 2020, the Company’s effective tax rate was a benefit of 16.0% compared to 0.0% for the six months ended June 30, 2019.  The Company’s effective tax rate for the six months ended June 30, 2020 varies with the statutory rate primarily due to the favorable impact of nondeductible stock-based compensationassociated with the CARES Act and the changes in the valuation allowance related to certain deferred tax assets generated or utilized in the applicable period.  The Company’s deferred tax assets have been fully offset by a valuation allowance at SeptemberJune 30, 2019,2020, and the Company expects to maintain this valuation allowance until there is sufficient evidence that future earnings can be achieved, which is uncertain at this time.

The IRS examination team has completed its examination of the Company’s 2013, 2014, and 2015 U.S. tax returns and proposed adjustments with respect to certain items that were reported by the Company for the 2013 tax year.  In June 2018, the Company received the Revenue Agent Report from the IRS.  The Company believes that it has accurately reported all amounts in its tax returns and has submitted an administrative protest with the IRS contesting the examination team’s proposed adjustments.  The Company intends to vigorously defend its reported positions and believes the ultimate resolution of the adjustments proposed by the IRS examination team will not have a material adverse effect on its consolidated financial statements.

7.9. Stock-Based Compensation

Stock Options

The following table summarizes stock-based compensation expense reflected in the consolidated statements of operations:

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

Three Months Ended

June 30

 

 

Six Months Ended

June 30

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

(in thousands)

 

 

(in thousands)

 

Research and development

 

$

1,885

 

 

$

988

 

 

$

5,235

 

 

$

2,924

 

 

$

7,527

 

 

$

1,659

 

 

$

19,044

 

 

$

3,350

 

General and administrative

 

 

3,495

 

 

 

1,757

 

 

 

8,855

 

 

 

4,859

 

 

 

7,269

 

 

 

2,824

 

 

 

15,060

 

 

 

5,360

 

 

$

5,380

 

 

$

2,745

 

 

$

14,090

 

 

$

7,783

 

 

$

14,796

 

 

$

4,483

 

 

$

34,104

 

 

$

8,710

 


Restricted Stock Units (RSUs)

The following table summarizes stock option activityRSUs as of SeptemberJune 30, 2019, and changes during the nine months ended September 30, 2019,2020, under the Second Amended and Restated Long Term Incentive Plan (LTIP Plan) agreement and standalone option agreements:

 

 

 

Number of Options

 

 

Weighted-Average

Exercise Price

 

Outstanding at January 1, 2019

 

 

3,320,571

 

 

 

21.20

 

Granted

 

 

1,624,133

 

 

 

64.94

 

Exercised

 

 

(395,641

)

 

 

16.30

 

Forfeited

 

 

(276,306

)

 

 

34.42

 

Outstanding at September 30, 2019

 

 

4,272,757

 

 

 

37.51

 

Exercisable at September 30, 2019

 

 

1,743,886

 

 

 

22.56

 

 

 

Number of RSUs

 

 

Weighted-Average

Grant Date Fair Value

 

Outstanding at January 1, 2020

 

 

50,000

 

 

$

72.70

 

Granted

 

 

24,751

 

 

$

184.00

 

Vested

 

 

 

 

$

 

Forfeited

 

 

 

 

$

 

Outstanding at June 30, 2020

 

 

74,751

 

 

$

109.55

 

 

As of June 30, 2020, the performance targets for the performance-based RSUs have not been met. Accordingly, the fair value related to these performance-based RSUs of approximately $4.2 million has not been recognized. During the quarter ended June 30, 2020, the Company recognized $0.3 million in compensation expense related to time-based RSUs.

Stock Options

The following table summarizes stock option activity as of June 30, 2020, and changes during the six months ended June 30, 2020, under the LTIP and standalone option agreements:

 

 

Number of Options

 

 

Weighted-Average

Exercise Price

 

Outstanding at January 1, 2020

 

 

4,038,949

 

 

$

41.24

 

Granted

 

 

973,999

 

 

$

203.19

 

Exercised

 

 

(47,351

)

 

$

37.51

 

Forfeited

 

 

(171,917

)

 

$

94.68

 

Outstanding at June 30, 2020

 

 

4,793,680

 

 

$

72.27

 

Exercisable at June 30, 2020

 

 

2,240,699

 

 

$

33.31

 

Stock-based compensation expense for the three and six months ended June 30, 2020, included accelerated recognition of expense due to modifications of outstanding stock options as a result of the death of an executive and employees who entered into consulting agreements at the termination of employment, which were considered to be non-substantive services. Accordingly, the Company recognized $2.9 million and $10.0 million for the three and six months ended June 30, 2020, respectively.

As of June 30, 2020, the Company has approximately 303,000 shares of performance-based stock options for which the performance targets have not been met.  Accordingly, the fair value related to these performance-based stock options of approximately $34.1 million has not been recognized.

The total intrinsic value of all outstanding options and exercisable options at SeptemberJune 30, 20192020 was $184,473,000$448.7 million and $100,782,000,$278.2 million, respectively.

Restricted Stock Units (RSUs)

As of September 30, 2019, the Company granted 50,000 RSUs under a Restricted Stock Unit Agreement. As the awards granted are performance-based, there was $3,635,000 of unrecognized compensation expense related to these RSUs.

 

 

Number Performance Based RSUs

 

 

Weighted-Average

Grant Date Fair Value

 

Outstanding at January 1, 2019

 

 

 

 

 

 

Granted

 

 

50,000

 

 

 

72.70

 

Vested

 

 

 

 

 

 

Forfeited

 

 

 

 

 

 

Outstanding at September 30, 2019

 

 

50,000

 

 

 

72.70

 


8.10. Net Loss per Share

The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders:

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

Three Months Ended

June 30

 

 

Six Months Ended

June 30

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

(in thousands, except share and per share data)

 

 

(in thousands, except share and per share data)

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(39,694

)

 

$

(30,835

)

 

$

(103,228

)

 

$

(54,963

)

 

$

(67,581

)

 

$

(34,380

)

 

$

(116,520

)

 

$

(63,534

)

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average number of common shares

used in net loss per share – basic

 

 

30,110,391

 

 

 

28,704,853

 

 

 

30,004,211

 

 

 

27,022,269

 

 

 

33,265,778

 

 

 

30,069,048

 

 

 

33,243,931

 

 

 

29,950,241

 

Dilutive potential common shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average number of common shares

used in net loss per share – diluted

 

 

30,110,391

 

 

 

28,704,853

 

 

 

30,004,211

 

 

 

27,022,269

 

 

 

33,265,778

 

 

 

30,069,048

 

 

 

33,243,931

 

 

 

29,950,241

 

Net loss per share – basic

 

$

(1.32

)

 

$

(1.07

)

 

$

(3.44

)

 

$

(2.03

)

 

$

(2.03

)

 

$

(1.14

)

 

$

(3.51

)

 

$

(2.12

)

Net loss per share – diluted

 

$

(1.32

)

 

$

(1.07

)

 

$

(3.44

)

 

$

(2.03

)

 

$

(2.03

)

 

$

(1.14

)

 

$

(3.51

)

 

$

(2.12

)

 

The number of weighted average options that were not included in the diluted earnings per share calculation because the effect would have been anti-dilutive represented 4,272,7574,793,680 and 3,337,2623,845,874 shares for the nine months ended September 30, 2019 and 2018, respectively.


9. Subsequent Events

On October 9, 2019, the Company and AbbVie entered into the Amended AbbVie Agreement pursuant to which the Company reacquired the development, manufacturing, and commercialization rights concerning its proprietary Nrf2 activator product platform originally licensed to AbbVie in the License Agreement and the Collaboration Agreement. Except as otherwise set forth in the Amended AbbVie Agreement, the other provisions of the License Agreement and the Collaboration Agreement have been terminated. Under the Amended AbbVie Agreement, certain licenses granted to AbbVie will continue, for which AbbVie has granted exclusive sublicenses to the Company, resulting in its reacquiring worldwide rights to bardoxolone, excluding certain Asian countries that the Company previously licensed to KKC, and worldwide rights to omaveloxolone and the other second-generation Nrf2 activators (the Second-Generation Activators), in each case that the Company had licensed to AbbVie under the License Agreement and the Collaboration Agreement.  In exchange, the Company will pay AbbVie $330,000,000, of which $75,000,000 is payable on December 8, 2019, $150,000,000 is payable on June 30, 2020 and $105,000,000 is payable on November 30, 2021.  If the Company raises cash proceeds of $200,000,000 or more in one or more equity offerings, it is required to prepay AbbVie $25,000,000, which prepayment will reduce the amount payable to AbbVie on November 30, 2021, from $105,000,000 to $80,000,000.  The Company also will pay AbbVie an escalating, low single-digit royalty on worldwide net sales, on a product-by-product basis, of omaveloxolone and an identified list of existing Second-Generation Activators. By reacquiring its rights, the Company was relieved from its obligations under the License Agreement and the Collaboration Agreement.  

On October 9, 2019, the Company entered into the Amendment with the Lenders, which amended the Restated Loan Agreement entered into among Reata and the Lenders on June 14, 2018.  Under the Amendment, the Term B Loan availability was increased from $45,000,000 to $75,000,000 and the availability period was increased from within 30 days to 60 days after the achievement of the one of two milestones. As one of the milestones was achieved on October 14, 2019, the availability period will end on December 13, 2019.  

Under the Restated Loan Agreement, the Company has significantly increased its current obligations, but the Company believes that its current cash, along with its access to additional equity or debt funding, will enable the Company to meet its current obligations through December 31, 2020.  

On October 15, 2019, the Company entered into the Lease Agreement, relating to the lease of approximately 327,400 square feet of office and laboratory space located in Plano, Texas. The term of the Lease is estimated to commence mid-2022, when construction is completed, and continue for 16 years, with up to 10 years of extension at the Company’s option. The initial annual base rent will be determined based on the project cost, subject to an initial annual cap of approximately $13,344,000, which may increase in certain circumstances.  Beginning in the third lease year, the base rent will increase 1.95% per annum each year.  In addition to the annual base rent, the Company will pay for taxes, insurance, utilities, operating expenses, assessments under private covenants, maintenance and repairs, certain capital repairs and replacements, and building management fees.

respectively.


Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes and other financial information appearing in this Quarterly Report on Form 10-Q.  Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, operations, and product candidates, includes forward-looking statements that involve risks and uncertainties.  Factors that may cause actual results to differ materially from current expectations include, among other things, those described under the heading “Risk Factors” and discussed elsewhere in this Quarterly Report on Form 10-Q.

Overview

We are a clinical stageclinical-stage biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies that change patients’ lives for the better.  We concentrate on small-molecule therapeutics with novel mechanisms of action for the treatment of severe, life-threatening diseases with few or no approved therapies.  Our lead programs are in rare forms of CKDchronic kidney disease (CKD) and a rare forms of neurological disease.  The Company’sWe have announced positive topline data from registrational trials for both of our lead product candidates, bardoxolone methyl (bardoxolone) in patients with CKD caused by Alport syndrome and omaveloxolone in patients with a neurological disease,disorder called Friedreich’s ataxia (FA).  Both bardoxolone and omaveloxolone activate the transcription factor Nrf2 to normalize mitochondrial function, restore redox balance, and resolve inflammation.  Because mitochondrial dysfunction, oxidative stress, and inflammation are features of many diseases, we believe bardoxolone and omaveloxolone have many potential clinical applications.  We possess exclusive, worldwide rights to develop, manufacture, and commercialize bardoxolone, omaveloxolone, and our next-generation Nrf2 activators, excluding certain Asian markets for bardoxolone in certain indications, which are licensed to KKC.

On November 11, 2019, we announced thatRegulatory Update

Bardoxolone for CKD Caused by Alport Syndrome

Following the announcement of positive, year one data from the Phase 3 portion of the CARDINAL study of bardoxolone in patients with CKD caused by Alport syndrome met its primaryin November 2019, we have been engaged in discussions with the U.S. Food and key secondaryDrug Administration (FDA) regarding the Year 1 endpoints.  After 48 weeks of treatment, patients treated with bardoxoloneefficacy and safety results.  We have had a statistically significant improvementType C meeting where the FDA expressed concerns with basing an NDA for accelerated approval on the Year 1 data and recommended that we consider submitting the NDA with Year 2 data based, in part, on the assumption that there would not be much delay in NDA submission.  Following the Type C meeting, we provided written responses, and engaged in follow up informal meetings, that we believe addressed the FDA comments regarding the Year 1 results.  Accordingly, we recently requested and were granted a pre-NDA meeting by the FDA to discuss the NDA submission content and plans.

Our plan has been, and continues to be, to submit the NDA for bardoxolone in Alport syndrome during fourth quarter of 2020 for accelerated approval based on the one-year data from the Phase 3 portion of CARDINAL.  If the second-year results are available during an acceptable time frame, we may be able to submit the second-year data to the NDA during the review process and before the FDA makes a determination about accelerated approval.  This may extend the PDUFA date, but could also result in consideration of full approval, rather than accelerated approval.  Alternatively, the FDA could recommend that we wait for the second-year data from CARDINAL to file the NDA.  This would permit us to file for full approval but would delay the filing until the first quarter of 2021 compared to placeboour current guidance of filing by the end of this year.  This timing assumes that we can complete the activities necessary to provide the Year 2 data to the FDA on a timely basis and is, of course, subject to uncertainty resulting from the COVID-19 pandemic.  As a result of the measures taken in mean eGFR of 9.50 mL/min/1.73 m2 (p<0.0001).  After 48 weeks of treatmentresponse to the pandemic, and a four-week withdrawal period, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean retained eGFR of 5.14 mL/min/1.73 mbased on current operational metrics, at this time we believe that the timeline for Year 2 (p=0.0012).  Bardoxolone treatment was generally reported data availability is unlikely to be well-tolerated and showed a similar safety profile toaffected by COVID-19.

Omaveloxolone for Friedreich’s Ataxia

Following the Phase 2 portionannouncement of the CARDINAL study.  Based on these positive results, anddata from the MOXIe Part 2 study in October 2019, we have planned, subject to discussionsdiscussion with regulatory authorities, the Company plans to proceed with thea submission of regulatory filings for marketing approval in the United States and internationally.

On October 14, 2019, we announced that the registrational Part 2 portion of the MOXIe Phase 2 trial of omaveloxolone in patients with FA met its primary endpoint of change in mFARS relative to placebo after 48 weeks of treatment.  Patients treated with omaveloxolone (150 mg/day) demonstrated a statistically significant, placebo-corrected 2.40 point mean improvement (decrease) in mFARS after 48 weeks of treatment (p=0.014).  Omaveloxolone treatment was generally reported to be well-tolerated.  Based on these positive results, and subject to discussions with regulatory authorities, the Company plans to proceed with the submission of regulatory filings for marketing approval of


omaveloxolone for the treatment of FA in the United StatesStates.  We recently completed a Type C meeting in which the FDA provided us with guidance that it does not have any concerns with the reliability of the modified Friedreich’s Ataxia Rating Scale (mFARS) primary endpoint results in the MOXIe Part 2 study.  Nevertheless, the FDA is not convinced that the MOXIe Part 2 results will support a single study approval without additional evidence that lends persuasiveness to the results.  In preliminary comments for the meeting, the FDA stated that we will need to conduct a second pivotal trial that confirms the mFARS results of the MOXIe Part 2 study with a similar magnitude of effect.  

In response to the preliminary comments, the Friedreich’s Ataxia Research Alliance (FARA), key FA clinicians, and internationally.we provided the FDA with information to demonstrate that it will be difficult to conduct an additional, prospective clinical trial in FA because of the very slow progression rate of FA, the limited number of FA patients available for clinical research, the small number of clinical trial investigators who can conduct the mFARS exam, and the impact of the COVID-19 pandemic on the ability to conduct neuroscience clinical trials.  Thus, conducting an additional pivotal study would result in a long delay in the availability of a potentially effective therapy to patients with a progressive, life-threatening disease with no treatment options.  The FDA acknowledged the unmet need of patients with FA, reiterated its commitment to facilitate the development of omaveloxolone within the constraints of the regulatory standards, and emphasized its willingness to consider all available options to meet the regulatory standards.  The FDA also acknowledged that launching a new, neuroscience clinical trial now may not be possible because of the COVID-19 pandemic.

WeAt the Type C meeting, to address the FDA’s requirement, FARA, key opinion leaders, and Reata proposed a second study (the “crossover study”) to provide additional evidence of effectiveness.  The study would measure the effect of omaveloxolone on mFARS in patients who were previously randomized to placebo in the MOXIe Part 2 study and are also conducting twobeing treated with omaveloxolone in the MOXIe open-label extension study.  The FDA acknowledged that a study like the proposed crossover study could provide important additional registrational trials:  information and asked us to submit a design for the crossover study for their consideration.

If the FDA accepts this approach, we expect to complete the crossover study as early as the fourth quarter of this year.  Assuming that the FDA views the crossover study data as sufficiently positive to provide confirmatory evidence, our plan would be to submit an NDA during the first quarter of 2021.  If the FDA rejects the proposal or if the data are not supportive, we will evaluate whether it is feasible to conduct a second pivotal study in FA patients as suggested by the FDA.  Regardless of the interaction with the FDA, we plan to pursue marketing approval outside of the United States.

Second Quarter 2020 Key Developments

Strategic Investment from Blackstone Life Sciences

On June 24, 2020, we closed a Development and Commercialization Funding Agreement (Development Agreement) with an affiliate of Blackstone Life Sciences, LLC (BXLS) that provides funding for the development and commercialization of bardoxolone for the treatment of CKD caused by Alport syndrome, autosomal dominant polycystic kidney disease (ADPKD), and certain other rare CKD indications. The Development Agreement includes a $300 million payment by the Blackstone affiliate in return for various percentage royalty payments on worldwide net sales of bardoxolone by Reata and its licensees, other than KKC.  The royalty percentage will initially be in the mid-single digits and in future years can vary between higher-mid single digit percentages to low-single digit percentages depending on various milestones, including indication approval dates, cumulative royalty payments, and cumulative net sales. Pursuant to the Development Agreement, we have granted BXLS a security interest in substantially all of our assets.

In addition, affiliates of BXLS paid us an aggregate of $50.0 million to purchase an aggregate of 340,793 shares of our Class A common stock, par value $0.001 per share, at $146.72 per share.

In connection with the closing of the Development Agreement, we fully paid off our senior loan with Oxford Finance LLC and Silicon Valley Bank that included $155.0 million in principal and $12.1 million in exit and prepayment fees.


FALCON studyingTrial Enrollment Resumed

In March 2020, we temporarily paused enrollment of new patients in the global Phase 3 FALCON trial of bardoxolone in patients with ADPKD due to the emergence of COVID-19 as a global public health threat. We expect to enroll a total of approximately 300 patients worldwide.  We began to lift the screening hold in FALCON in June 2020, and CATALYST, studyingcurrently, all sites are able to screen patients and approximately half are able to randomize patients. The first patients have now reached the second year of the trial. The measures we implemented to the conduct of FALCON in response to COVID-19 have been effective, and we anticipate no meaningful impact on data integrity due to COVID-19.

Adjustments to Operations Due to COVID-19

Beginning in the first quarter of 2020, in accordance with recommendations from local, state, and national health authorities, we implemented and continue to enforce work-from-home measures and additional safety protocols to protect employees and the broader community and to ensure business continuity.  These measures include restricting on-site staff to only those required to execute their job responsibilities and limiting the number of staff working in our research and development laboratory.  We also continue to limit in-person meetings and business travel.  We will continue to monitor this dynamic situation closely and will take additional measures as required to preserve the safety of our employees and the broader community.

CARDINAL and EAGLE Trials Adapted for Continuity

The Phase 3 CARDINAL trial of bardoxolone in patients with CKD caused by Alport syndrome is fully enrolled and ongoing.  As previously announced, we are in the process of completing the Year 2 portion of our CARDINAL Phase 3 study.  As COVID-19 emerged as a rarepandemic with serious public health implications during the first quarter of 2020, we undertook a series of measures to protect the health and serious formsafety of CTD-PAH.patients and health care workers involved in our ongoing clinical studies, while maintaining the conduct of our studies in accordance with guidance provided by the FDA and the European Medicines Agency.  For example, we have implemented the use of at-home visits as an alternative to in-clinic visits when necessary to collect blood draws and to assess patient safety.  We initiated enrollmentalso arranged for home delivery of the study drug to patients.  

At this time, approximately 60% of the 157 patients randomized to the CARDINAL Phase 3 cohort have completed the Year 2 final off-treatment visit.  The last study visits are anticipated to occur during the fourth quarter of 2020, which is consistent with our pre-COVID-19 timeline.  Currently, almost all sites are allowing on-site or remote monitoring.  

Patients who participated in FALCONthe CARDINAL study may be eligible to enroll in May 2019.an open-label extension study known as EAGLE.  We completed enrollment of CATALYST and expect to have top-line data in mid-2020.  We have received orphan drug designation from the United States Food and Drug Administration (FDA) for bardoxoloneare implementing procedures for the treatmentconduct of Alport syndrome, PAH,EAGLE that are similar to those being used in CARDINAL to ensure continued access to bardoxolone and ADPKD and for omaveloxoloneappropriate safety monitoring.

MOXIe Extension Study Advanced with Modifications

The MOXIe Part 2 trial was completed prior to the onset of the COVID-19 pandemic.  Patients who participated in MOXIe Part 1 or 2 were eligible to enroll in an open-label extension portion of the study.  We are implementing procedures for the treatmentconduct of FA.the MOXIe extension study that are similar to those being used in our other ongoing studies to ensure continued access to omaveloxolone and appropriate safety monitoring.

BARCONA Study of Bardoxolone in Patients with COVID-19

Researchers at NYU Grossman School of Medicine (NYU) are initiating an Investigator-Sponsored Trial (IST), known as BARCONA, to study the effect of bardoxolone in patients suffering from COVID-19.  Serious complications of COVID-19 are caused by excessive, systemic inflammation, which can result in dysfunction of the lungs, kidneys, and other organs.  Acute kidney injury has been reported to occur in up to 28% of all hospitalized COVID-19 patients, and in up to 72% of patients who do not survive COVID-19.  Bardoxolone and its analogs have demonstrated anti-inflammatory activity in animal models of acute lung and kidney injury, have increased survival in models of systemic inflammation, suppress replication of several types of viruses and have shown improvements in kidney function in multiple clinical trials that enrolled over 3,000 patients with various forms of chronic kidney disease.  


The chart belowPhase 2 BARCONA study is a summaryrandomized, placebo-controlled, double-blind trial that will enroll 40 patients with a primary endpoint of safety and treatment duration of up to 29 days in hospitalized patients.  Major exclusion criteria include patients who are intubated and on invasive mechanical ventilation for three or more days, prior hospitalization for heart failure, or estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2.  To further mitigate any safety risk, enrollment will be paused after enrollment of the initial five patients to assess safety.  As with all trials conducted at NYU, the trial will be overseen by a Data Safety Monitoring Board that meets every other week.

We were involved in the design of the trial, have a representative on the study’s executive steering committee, and are providing drug supply, as requested by NYU.  Any further enrollment in a potential Phase 3 trial will be gated based on an assessment of Phase 2 safety and activity, as well as feasibility of conducting a Phase 3 trial.

Background: Our Programs

The following chart outlines each of our current registrational programs:programs by indication and phase:

Program

Current Registrational Trial

Next Expected Milestone

  CKD caused by Alport syndrome

CARDINAL

Regulatory Filings

Bardoxolone

  FA

MOXIe

Regulatory Filings

Omaveloxolone

  ADPKD

FALCON

Completion of Enrollment

Bardoxolone

  CTD-PAH

CATALYST

Phase 3 Data

Bardoxolone

Programs in CKD

We are developing bardoxolone for the treatment of patients with the following rare forms of CKD:  

Alport syndrome in our registrational CARDINAL study;

ADPKD in our registrational FALCON study; and

three other rare forms of CKD in our Phase 2 PHOENIX study.  

In addition, KKC, our strategic collaborator in CKD, is currently conducting its registrational trial of bardoxolone in diabetic (type 1 and 2) CKD in Japan.  KKC completed patient enrollment in this trial in June 2019 and expects to have topline data in the first half of 2022.

NYU has initiated an IST (Phase 2/3 trial) of bardoxolone in COVID-19 patients called BARCONA.  

*The CARDINAL study reported one-year data in November 2019 and is an ongoing two-year study.

**See discussion above under “Regulatory Update-Omaveloxolone for Friedreich's Ataxia”.

Programs in CKD

We are developing bardoxolone for the treatment of patients with certain rare forms of CKD.  CKD is characterized by a progressive worsening in the rate at which the kidney filters waste products from the blood, called the glomerular filtration rate (GFR). When GFR gets too low, patients develop end-stage kidney disease (ESKD) and require dialysis or a kidney transplant to survive.  Dialysis leads to a reduced quality of life and increases the likelihood of serious and life-threatening complications.  The five-year survival rate for hemodialysis patients is only approximately 42%.

eGFREstimated glomerular filtration rate (eGFR) is an estimate of GFR that nephrologists use to track the decline in kidney function and progression of CKD.  In 11 separate CKD clinical trials, bardoxolone has been shown to improve eGFR in patients with diverse etiologies of CKD.  We believe that bardoxolone treatment has the potential


to delay or prevent GFR declines that cause the need for dialysis or a transplant in patients with Alport syndrome, ADPKD, and other rare forms of CKD.

Bardoxolone in CKD Caused by Alport Syndrome

We are developing bardoxolone for the treatment of patients with CKD caused by Alport syndrome, ADPKD, and other rare forms of CKD that, in the aggregate, affect more than 700,000 patients in the United States.  

Alport syndrome is a rare, and serious hereditary disease that can manifest as early as the first decadegenetic form of life, causes average annual declines in eGFR of approximately 3 to 4 mL/min/1.73 m2, and affects approximately 30,000 to 60,000 patientsCKD caused by mutations in the United States.  genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane in the kidney.  The kidneys of patients with Alport syndrome progressively lose the capacity to filter waste products out of the blood, which can lead to ESKD and the need for chronic dialysis treatment or a kidney transplant.  Alport syndrome affects both children and adults.  In patients with the most severe forms of the disease, approximately 50% of patients progress to dialysis by age 25, 90% by age 40, and nearly 100% by age 60.  According to the Alport Syndrome Foundation, Alport syndrome affects approximately 30,000 to 60,000 people in the United States.  There are currently no approved therapies forto treat CKD caused by Alport syndrome anywhere in the world.  syndrome.

OnIn November 11, 2019, we announced the topline, Year 1 results fromthat the Phase 3 portion of the CARDINAL studyingstudy of bardoxolone in Alport syndrome patients.  The Phase 3 portion of CARDINAL is an international, multi-center, double-blind, placebo-controlled, randomized registrational trial that enrolled 157 patients with Alport syndrome at approximately 50 study sites in the United States, Europe, Japan, and Australia.  Pediatric patients represented approximately 15% of enrolled patients.  Patients were randomized one-to-one to bardoxolone or placebo.  The primary endpoint for the study was the change in eGFR, an important measure of the ability of the kidney to filter waste products out of the blood, after 48 weeks of treatment.  The key secondary endpoint for the study was the change in retained eGFR after 48 weeks of treatment and withdrawal of drug for four weeks.  After 52 weeks, patients who completed the first 48 weeks of treatment are restarted on study drug with their original treatment assignments and continue on study drug for a second year.  The second-year on-treatment eGFR will be measured after 100 weeks of treatment and the retained eGFR will be measured at Week 104 after withdrawal of drug for four weeks.  Additionally, patients who complete the study and meet eligibility requirements can participate in the open-label extension.  The FDA has provided us with written guidance that, in patients with CKD caused by


Alport syndrome an analysis of retained eGFR demonstrating an improvement versus placebo after one year of bardoxolone treatment may support a NDA submission for accelerated approvalmet its primary and an improvement versus placebo after two years of treatment may support full approval.

key secondary Year 1 endpoints.  After 48 weeks of treatment, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean eGFR of 9.50 mL/min/1.73 m2 (p<0.0001).  Patients treated with bardoxolone experienced a statistically significant increase from baseline in mean eGFR of 4.72 mL/min/1.73 m2(p<0.0004), while patients treated with placebo experienced a statistically significant decline from baseline in mean eGFR of -4.78 mL/min/1.73 m2 (p<0.0002).  Patients’ retained eGFR was also assessed atAt Week 52, after 48 weeks of treatment and four weeks of drug withdrawal.  At Week 52,off-treatment period, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean retained eGFR of 5.14 mL/min/1.73 m2 (p=0.0012).  Patients treated with bardoxolone experienced a nonsignificant decline from baseline, while patients in mean retained eGFRthe placebo arm of -0.96CARDINAL lost an average of 6.1 mL/min/1.73 m2 (p=0.45), while patients treated with placebo experienced.  The retained benefit of kidney function during the off-treatment period is a statistically significant decline from baseline in mean retained eGFR of -6.11 mL/min/1.73 m2 (p<0.0001).  Similar efficacy at Week 48 and Week 52 was observed across multiple subgroups, including among pediatric patients.

Bardoxolone was generally reported to be well tolerated in this study and showed a similar safety profile to the Phase 2 portion ofkey regulatory endpoint for the CARDINAL study.  Seventy-five patients (97%) receiving bardoxolone and 73 patients (91%) receiving placebo experienced an adverse event (AE).  Nine patients (12%) receiving bardoxoloneFALCON studies.  Based on these positive results, and four patients (5%) receiving placebo discontinued study drug duesubject to an AE, and no individual AE contributeddiscussions with regulatory authorities, we plan to more than two discontinuations in either group.

Four patients (5%) receiving bardoxolone and 10 patients (13%) receiving placebo experienced a treatment-emergent serious adverse event (SAE).  No fluid overload or major adverse cardiac events were reported in patients treatedproceed with bardoxolone.  Blood pressure was reduced relative to baselinethe submission of regulatory filings this year for marketing approval in the bardoxolone group but was not significantly different between the two groups.  The reported AEs were generally mild to moderate in intensity, and the most common AEs observed more frequently in patients treated with bardoxolone compared to patients treated with placebo were increases in aminotransferases and muscle spasms.  Increases in aminotransferases are a pharmacological effect of bardoxolone, which increases production of aminotransferases in vitro. The aminotransferase increases observed in CARDINAL were associated with improvements (reductions) in total bilirubin and were not associated with liver injury, and we believe they are related to restoration of mitochondrial function.  Laboratory markers associated with pharmacodynamic activity, including urinary albumin to creatinine ratio and aminotransferases, were unchanged relative to placebo at Week 52 after a four week withdrawal.United States.

Bardoxolone in ADPKD

ADPKD is an inherited,a rare and serious hereditary form of CKD caused by a genetic defect in PKD1 or PKD2 and is characterized by genes leading to the formation of fluid-filled cysts in the kidneys.  Inflammation appearskidneys and other organs.  Cyst growth can cause the kidneys to play a role in cyst growthexpand up to five to seven times their normal volume, leading to pain and progressive loss of kidney function.  ADPKD affects both men and women of all racial and ethnic groups and is associatedthe leading inheritable cause of kidney failure with disease progression in ADPKD.  PKD1 is the most common mutation, causing about 85% of ADPKD cases, and patients generally progress to ESKD, on average, by age 54.  ADPKD is the most common single-gene disorder of the kidneys, and there are an estimated 400,000diagnosed population of 140,000 patients in the United States,States.  Despite current standard of care treatment, an estimated 50% of ADPKD patients progress to ESKD and require dialysis or a kidney transplant by 60 years of age.

In a Phase 2 study called PHOENIX, bardoxolone demonstrated a statistically significant increase from baseline in mean eGFR of 9.3 mL/min/1.73 m2 (p<0.0001) after 12 weeks of treatment in 31 patients with approximately 140,000 diagnosed.  The only therapy approvedADPKD.  Available historical data for ADPKD is tolvaptan, which was approved29 of these patients showed an average annual decline in eGFR of 4.8 mL/min/1.73 m2 in the three-year period prior to study entry.  The United States in 2018.

We have initiated a registrational Phase 3 trial called FALCONFood and Drug Administration (FDA) has provided us with written guidance that, in patients with ADPKD.ADPKD, an analysis of eGFR during the off-treatment period demonstrating an improvement versus placebo after one year of bardoxolone treatment may support accelerated approval, and an improvement versus placebo after two years of treatment may support full approval.  In May 2019, we began enrollment in FALCON, is an international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial studying the safety and efficacy of bardoxolone in approximately 300 patients with ADPKD randomized one-to-oneADPKD.  The enrollment of new patients was temporarily paused in March of 2020 due to active drug or placebo.  We began enrollmentsafety concerns related to the COVID-19 global pandemic, and the screening hold in FALCON was lifted in May 2019.June 2020 at some sites.  The FDA has provided ustrial will enroll a broad range of patients from 18 to 70 years old with guidance that, in patients with ADPKD, an analysis of retained eGFR demonstrating an improvement versus placebo after one year of bardoxolone treatment, may support an NDA submission for accelerated approval of bardoxolone for the treatment of ADPKD, and data demonstrating an improvement versus placebo in retained eGFR after two years of treatment may support full approval.  We will measure the retained eGFR benefit versus placebo at 52 weeks after treatment on study drug for 48 weeks and a four-week withdrawal of drug.  After 52 weeks, patients will resume study drug and will continue on study drug for a second year.  The second-year retained eGFR benefit will be measured at Week 104.between 30 to 90 mL/min/1.73 m².


Bardoxolone in Other Rare Forms of CKD

Three additional rare forms of CKD were studied in PHOENIX, was an open-label, multi-center Phase 2 trial evaluating the safety and efficacy of bardoxolone in patients with ADPKD, including IgA nephropathy (IgAN), type 1 diabetic CKD (T1D CKD), and focal segmental glomerulosclerosis (FSGS)(FSGS).  In aggregate, the prevalenceeach of these diseases exceeds 700,000 patients in the United States, representingPhase 2 cohorts, bardoxolone demonstrated a meaningful market for bardoxolone in rare forms of CKD.  A total of 103 patients were enrolled in the trial in four separate cohorts, including 31 patients with ADPKD, 26 with IgAN, 28 with T1D CKD, and 18 with FSGS.  Patients were treated with bardoxolone for 12 weeks in all four cohorts, and each cohort showed statistically significant increasesincrease from baseline in mean eGFR with the change in mean eGFR from baseline across all four cohortsafter 12 weeks of 7.8 mL/min/1.73 m2 (n=103; p<0.0001).  Of the patients that reached Week 12, 88% experienced increases in eGFR at Week 12.treatment.  We observed that bardoxolone significantly reduced mean systolic blood pressure by 3.8 mmHg (n=103; p=0.002) and mean diastolic blood pressure by 2.8 mmHg (n=103; p=0.0009).  Urinary albumin excretion was low upon study entry and remained unchanged by bardoxolone treatment (n=103; p=0.6).  The most commonly reported AE across all cohorts was muscle spasms, which were not associated with clinical signs or symptoms of muscle injury.  The overall rate of SAEs was low, with three patients reporting SAEs while they received trial drug, none of which were reported as related to bardoxolone.

Based on the eGFR improvements observed in PHOENIX patients, we plan to pursue IgAN, T1Deach of these rare and serious forms of CKD and FSGS as commercial indications.  We believe that registrational clinical trials similar


The FDA has granted orphan drug designation to the design of the Phase 3 CARDINAL and FALCON trials, with a two-year duration and a retained eGFR benefit endpoint after one and two years of treatment, would be sufficient to form the basis of an NDA submission to the FDA seeking approval of bardoxolone for the treatment of these formsAlport syndrome and ADPKD, and the European Commission has granted orphan drug designation to bardoxolone for the treatment of CKD.Alport syndrome.

Historical Development of Bardoxolone

Prior to our CARDINAL Phase 3 trial, bardoxolone has been evaluated in multiple clinical trials enrolling over 2,000 patients exposed to active drug and hasbardoxolone have demonstrated consistent, clinically meaningful improvement in kidney function across several disease states as measured by eGFR and other markers of kidney function.  Specifically, we have observed statistically significant increases in eGFR in all Phase 2 and Phase 3 clinical trials in seven distinctnumerous patient populations treated with bardoxolone, including patients with PAH and CKD caused by type 2 diabetes (T2D CKD), Alport syndrome, ADPKD, IgAN, T1D CKD, and FSGS.FSGS.  

We believe these data, in addition to the CARDINAL Phase 3 one-year data, support the potential for bardoxolone to delay or prevent dialysis, kidney transplant, and death in patients with Alport syndrome and other rare forms of CKD.  

Additional observations from the prior clinical trials of bardoxolone include the following:

 

Statistically significant increases in directly-measured GFR using the “gold standard” inulin clearance method, improvements in creatinine clearance, and reduction in the levels of blood waste products filtered by the kidney.  

Statistically significant improvements in eGFR versus baseline or placebo in six different types of CKD, including Alport syndrome, ADPKD, IgAN, T1D CKD, T2D CKD, and FSGS.

 

Sustained improvement in kidney function in long-term trials:  

 

o

In the Phase 2 portion of CARDINAL, bardoxolone treatment produced a statistically significant increase from baseline in mean eGFR of 10.4 mL/min/1.73 m2 (p<0.0001) after 48 weeks of treatment, which, based on historical data available for 22 of the patients prior to enrolling in the trial, represents a recovery of over two years of average decline in kidney function.

 

o

In two large, placebo-controlled clinical studies (BEAM and BEACON) in patients with T2D CKD, statistically significant increases in mean eGFR of 14.9 mL/min/1.73 m2 (p<0.001) and 5.6 mL/min/1.73 m2 (p<0.001), respectively, were sustained for at least one year.

 

Reduction in risk of adverse kidney outcomes, suggesting that bardoxolone treatment preserves kidney function and may delay the onset of kidney failure in patients with T2D and stage 4 CKD:

 

o

In BEACON, patients randomized to bardoxolone were significantly less likely to experience adverse kidney outcomes as defined by a composite endpoint consisting of ≥30% decline from baseline in eGFR, eGFR <15 mL/min/1.73 m2, or ESKD events (HR=0.48, p<0.0001).  


 

o

In BEACON, bardoxolone treatment resulted in a decreased number of kidney-related SAEs and ESKD events.  

 

Statistically significant improvement in retained eGFR which isduring the eGFR change after a four-week withdrawal of drug, above baselineoff-treatment period in BEAM, BEACON, and the Phase 2 portion of CARDINAL.  To our knowledge, bardoxolone isCARDINAL at one year, and the first therapy to produce a retained eGFR benefit that is above baseline in a long-term CKD trial.Phase 3 portion of CARDINAL at one year.  

 

o

The FDA has provided guidance to us and other sponsors that clinical trials with a retainedan eGFR benefit versus placebo during the off-treatment period may support approval in certain rare forms of CKD.  The FDA has provided guidance to us that, in patients with CKD caused by Alport syndrome or ADPKD, a retainedan eGFR benefit versus placebo during the off-treatment period after one year of bardoxolone treatment may support accelerated approval and after two years of bardoxolone treatment may support full approval.

 

o

We believe the retained eGFR benefit during the off-treatment period observed in these clinical trials demonstrates that bardoxolone treatment improved the structure of the kidney, modified the course of the disease, and may prevent or delay kidney failure and the need for dialysis or a kidney transplant.

Recently, the mechanism underlying the regulation of GFR by the Keap1/Nrf2 pathway was investigated in the laboratory of Dr. Naoki Kashihara at the Kawasaki Medical School in Japan.  RTA dh404 (10 mg/kg/day) increased single nephron GFR in the control group but not in mice lacking the Nrf2 gene (p<0.05).  The glomerular afferent/efferent arteriole ratio was not significantly altered in any group, indicating that activation of the Keap1/Nrf2 pathway increases GFR by increasing glomerular effective filtration area without affecting the afferent/efferent arteriole ratio.

Programs in Neurological Diseases

We are developing omaveloxolone for the treatment of patients with FA and recently announced the results of our registrational Phase 2 MOXIe trial in patients with FA.  In addition, we have studied omaveloxolone and other Nrf2 activators in preclinical models of Huntington’s disease, ALS, Parkinson’s disease, Alzheimer’s disease and epilepsy, and we plan to pursue the development of omaveloxolone and our other Nrf2 activators for one or more of these diseases.  We are also developing RTA 901 in neurodegeneration and neuroprotection indications.

Omaveloxolone in FA


We are developing omaveloxolone for the treatment of patients with FA, an inherited, debilitating, and degenerative neuromuscular disorder that is usuallytypically diagnosed during adolescence and can ultimately leadtypically leads to premature death.  Patients with FA experience progressive loss of coordination, muscle weakness, and fatigue, which commonly progressprogresses to motor incapacitation and wheelchair reliance.  Symptoms generally occur in children, with patients requiring a wheelchair by their teens or early 20s.  Based on literature and proprietary research, we believe FA affects approximately 5,000 children and adults in the United States and 22,000 individuals globally.  There are currently no approved therapies for the treatment of FA anywhere in the world.  to treat FA.

Our Phase 2 trial, called MOXIe, was a two-part, international, multi-center, randomized, double-blind, placebo-controlled registrational trialIn October 2019, we announced that studied the safety and efficacy of omaveloxolone in patients with FA.  Additionally, patients who completed the study and meet eligibility requirements can participate in the open-label extension.  Part 1 of MOXIe was a dose-ranging study designed to assess safety and identify an optimal dose of omaveloxolone to test in the registrational part 2 portion of the study. A dose of 150 mg per day was selected for part 2, and no safety concerns were noted by the data safety monitoring board (DSMB) that oversaw the trial and reviewed all safety data.  

Based on data from part 1 of MOXIe we designed and powered part 2 of MOXIe, an international, multi-center, double-blind, placebo-controlled, randomized registrational Phase 2 trial that enrolled 103of omaveloxolone in patients with FA at 11 trial sites in the United States, Europe, and Australia.  Part 2 of MOXIe is the largest global, interventional trial ever conducted in FA.  Patients were randomized one-to-one to omaveloxolone or placebo.  The primary analysis population included patients without pes cavus (n=82), a musculoskeletal foot deformity that may interfere with the patient’s ability to perform some components of the neurological exam used to score themet its primary endpoint of the study.  Safety analyses were evaluated in the all randomized population (n=103).


The primary endpoint for the trial was the change in the mFARS score relative to placebo after 48 weeks of treatment.  The mFARS isPatients treated with omaveloxolone (150 mg/day) demonstrated a physician-assessed neurological rating scale used to measure FA disease progression.  The FDA has indicated that mFARS is an acceptable primary endpoint to evaluate the effect of omaveloxolone for the treatment of patients with FA.  Omaveloxolone treatment demonstrated statistically significant, evidence of efficacy for the primary endpoint of the trial, producing a placebo-corrected 2.40 point mean improvement (decrease) in mFARS (n=82; p=after 48 weeks of treatment (p=0.014).  Patients treated with omaveloxolone experienced a meandemonstrated improvement (decrease) in mFARS of 1.55 points from baseline, while patients treated with placebo experienced a mean worsening (increase) in mFARS of 0.85 points from baseline.  

Further, the observed placebo-corrected improvements in mFARS were time-dependent, increasing over the course of treatment with the largest improvement observed after 48 weeks of treatment.every subcategory measured under mFARS.  Omaveloxolone treatment also demonstrated statistically significant evidence of efficacy in mFARS at Week 48 when the pes cavus patients were included in the analysis (the all randomized population).  In the all randomized population, omaveloxolone treatment produced a statistically significant, placebo-corrected 1.93 point mean improvement (decrease) in mFARS (n=103; p=0.034).  Omaveloxolone treatment also improved several secondary endpoints included in the trial.

Omaveloxolone was generally reported to be generally well-tolerated in this trial.  Four (8%)well-tolerated.  The FDA and the European Commission have granted orphan drug designation to omaveloxolone patients and two (4%)for the treatment of FA.  

As discussed above under “Regulatory Update-Omaveloxolone for Friedreich’s Ataxia,” the FDA will consider whether a crossover study of omaveloxolone using placebo patients discontinued trial drug due to an AE.  The reported AEsfrom MOXIe Part 2 who were generally mild to moderate in intensity, and the most common AEs (i.e., reported in > 20% of patients in either treatment group) observed more frequently in omaveloxolone compared to placebo were headache, nausea, increased aminotransferases, fatigue, and abdominal pain.  Increases in aminotransferases are a pharmacological effect of omaveloxolone, which increases production of aminotransferases in vitro, which we believe are related to restoration of mitochondrial function.  In MOXIe, the aminotransferase increases were associated with improvements (reductions) in total bilirubin and were not associated with liver injury.  

The overall rate of SAEs was low, with three patients on omaveloxolone and three patients on placebo reporting SAEs while on treatment.  Two additional omaveloxolone-treated patients reported SAEs approximately two weeks after receiving their final dose.  No new safety signals were identified, and the reported SAEs were sporadic and generally expected in FA patients.  In the three omaveloxolone patients who reported SAEs while receiving omaveloxolone, none led to discontinuation.  Atrial fibrillation was balanced and reported in one omaveloxolone and one placebo patient.  One omaveloxolone patient reported anemia that was due to a complication of a procedure and was considered unrelated to omaveloxolone.  One omaveloxolone patient reported multiple SAEs, including viral upper respiratory tract infection and laryngitis, along with palpitations, non-cardiac chest pain, and sinus tachycardia.  While several of these SAEs were considered possibly relatedcrossed over to omaveloxolone no imbalances in infection or arrhythmia adverse events were observed overalltreatment in the trial.

BasedMOXIe extension study could serve as additional confirmatory evidence.  If the FDA accepts the proposal, we could have completed data from the crossover study in the fourth quarter of this year.  Assuming that the crossover study data are sufficiently positive to provide confirmatory evidence, our plan would be to submit an NDA during the first quarter of 2021.  If the FDA rejects the proposal or if the data are not supportive, we will evaluate whether it is feasible to conduct a second pivotal study on FA patients as suggested by the positive MOXIe results, and subject to discussionsFDA.  Regardless of the interaction with regulatory authorities,the FDA, we plan to proceed with the submission of regulatory filings forpursue marketing approval inoutside of the United StatesStates.

Omaveloxolone in Other Potential Indications

In addition, we have observed compelling activity of omaveloxolone and internationally.our other Nrf2 activators in preclinical models of Parkinson’s disease, dementia, epilepsy, Huntington’s disease, and amyotrophic lateral sclerosis (ALS), and we plan to pursue the development of omaveloxolone and our other Nrf2 activators for one or more of these diseases.

RTA 901 in Neurodegeneration and Neuroprotection Diseases

We are also developing RTA 901 in neurological indications.  RTA 901 is the lead product candidate from our Hsp90 modulator program, which includes highly potent and selective C-terminal modulators of Hsp90.program.  We have observed favorable activity of RTA 901 in a range of preclinical models of neurodegeneration and neuroprotection,neurological disease, including models of diabetic neuropathy, neural inflammation,neuroinflammation, and neuropathic pain.  RTA 901, administered orally once-daily, has been observed to rescue existing nerve function, restore thermal and mechanical sensitivity, and improve nerve conductance velocity and mitochondrial function in rodent disease models.  We have completed a Phase 1 trial to evaluate the safety, tolerability, and pharmacokinetic profile of RTA 901 administered orally, once-daily in healthy adult volunteers.  Novolunteers, and no safety or tolerability concerns were reported.  We plan to continue development for RTA 901 in neurological diseases, such as diabetic neuropathy.  We are the exclusive licensee of RTA 901 and have worldwide commercial rights.

Other Clinical Programs

In addition, to our lead programs in rare forms of CKD and rare forms of neurological diseases, we are exploring additional clinical and preclinical programs.  We believe bardoxolone has many potential clinical applications, and we are studying bardoxolone in CTD-PAH in our registrational Phase 3 CATALYST trial.developing RTA 1701, is the lead product candidate from our proprietary series of RORγt inhibitors, for the potential treatment of a broad range of autoimmune, inflammatory, and fibrotic diseases.  We have completed a Phase 1 trial to evaluate the safety, tolerability, and pharmacokinetic profile of RTA 1701 in healthy adult volunteers.  


Bardoxolone in CTD-PAH

We are studying bardoxolone in CTD-PAH, which is a late and often fatal manifestation of many types of autoimmune diseases, including systemic sclerosis (scleroderma), systemic lupus erythematosus, mixed connective tissue disease, and others.  CTD-PAH is a subset of PAH, which results in a progressive increase in pulmonary vascular resistance, ultimately leading to right ventricular heart failure and death.  Based on literature and proprietary research, we believe there are approximately 12,000 patients with CTD-PAH in the United States and 50,000 worldwide.

In comparison to patients with the idiopathic form of PAH (I-PAH), patients with CTD-PAH generally have a worse prognosis and experience a higher occurrence of small vessel fibrosis and pulmonary veno-obstructive diseases.  CTD-PAH represents approximately 30% of the overall PAH population and approximately 10 to 15% of patients with scleroderma or lupus erythematosus. Patients with CTD-PAH are less responsive to existing vasodilator therapies than patients with I-PAH and have a five-year survival rate of approximately 44%, in contrast with a five-year survival rate of approximately 68% for patients with I-PAH.  Currently approved therapies, all systemic vasodilators, are used to treat all etiologies of PAH.  A meta-analysis of 11 registrational trials comprised of more than 2,700 patients demonstrated that the currently approved therapies are less beneficial for patients with CTD-PAH compared to patients with I-PAH as measured by 6-minute walk distance (6MWD).  Patients with CTD-PAH experienced improvement in their 6MWD of only 9.6 meters, or approximately one-third, compared to the improvements observed in patients with I-PAH of 30 meters.  Bardoxolone is an Nrf2 activator, not a systemic vasodilator, and directly targets the bioenergetic and inflammatory components of PAH.  Additionally, because bardoxolone does not have systemic hemodynamic effects or cause drug-drug interactions in patients with PAH, it may be used in combination with other therapies to a greater incremental effect than an additional vasodilator.

Initial results from our Phase 2 LARIAT trial in patients with PAH showed that bardoxolone provided the greatest improvement in 6MWD to patients with CTD-PAH.  Patients with CTD-PAH treated with bardoxolone demonstrated a statistically significant increase in mean 6MWD of 38.2 meters (p<0.001) compared to baseline and a placebo-corrected change in 6MWD of 28.4 meters (p=0.07).  Further analysis of data from patients with CTD-PAH who would be eligible for inclusion in our Phase 3 trial, CATALYST, demonstrated a statistically significant increase in mean 6MWD of 42.7 meters (p<0.001) compared to baseline and a placebo-corrected change in 6MWD of 48.5 meters (p=0.005).

We are currently conducting CATALYST, an international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial that studies the safety and efficacy of bardoxolone in patients with CTD-PAH when added to standard-of-care therapy.  The trial has been fully enrolled with 202 patients with CTD-PAH, and we expect to have top-line data from the CATALYST trial in mid-2020.  Data from CATALYST demonstrating an improvement in 6MWD versus placebo may support an NDA submission for approval of bardoxolone for the treatment of CTD-PAH.  No safety concerns have been reported by the DSMB.

RTA 1701 in Autoimmune Diseases

RTA 1701 is the lead product candidate from our proprietary series of RORγt inhibitors for the potential treatment of a broad range of autoimmune, inflammatory, and fibrotic diseases.  RTA 1701 is an orally-bioavailable, RORγt-selective allosteric inhibitor that suppresses Th17 differentiation in vitro and demonstrates strong efficacy in rodent disease models of autoimmune disease.  RTA 1701 also potently suppresses production of IL-17A, a clinically important cytokine, in human immune cells and when dosed orally to non-human primates.  We have conducted a Phase 1 trial to evaluate the safety, tolerability, and pharmacokinetic profile of RTA 1701 in healthy adult volunteers.  No safety or tolerability concerns were reported, and we observed an acceptable pharmacokinetic profile.  We plan to continue development for RTA 1701 in autoimmune, inflammatory, or fibrotic diseases.  We retain all rights to our RORγt inhibitors, which are not subject to any existing commercial collaborations.


Financial Operations

Corporate Overview

To date, we have focused most of our efforts and resources on developing our product candidates and conducting preclinical studies and clinical trials.  We have historically financed our operations primarily through revenue generated from our collaborations with AbbVie and KKC, from sales of our securities, with secured loans, and secured loans.most recently from a strategic financing from BXLS.  We have not received any payments or revenue from collaborations other than nonrefundable upfront, milestone, and cost sharing payments from our collaborations with AbbVie and KKC, from the Development Agreement with BXLS, and from reimbursements of expenses under the


terms of our agreement with KKC.  We have incurred losses in each year since our inception, other than in 2014. As of SeptemberJune 30, 2019,2020, we had $240.1$610.4 million of cash and cash equivalents and an accumulated deficit of $523.6$827.0 million.

On October 9, 2019, we and AbbVie entered into the Amended AbbVie Agreement pursuant to which we reacquired the development, manufacturing, and commercialization rights concerning its proprietary Nrf2 activator product platform originally licensed to AbbVie in the License Agreement and the Collaboration Agreement. Except as otherwise set forth in the Amended AbbVie Agreement, the other provisions of the License Agreement and the Collaboration Agreement have been terminated. Under the Amended AbbVie Agreement, certain licenses granted to AbbVie will continue, for which AbbVie has granted exclusive sublicenses to us, resulting in our reacquiring worldwide rights to bardoxolone, excluding certain Asian countries that we previously licensed to KKC, and worldwide rights to omaveloxolone and the Second-Generation Activators, in each case that we had licensed to AbbVie under the License Agreement and the Collaboration Agreement.  In exchange, we will pay AbbVie $330 million, of which $75 million is payable on December 8, 2019, $150 million is payable on June 30, 2020, and $105 million is payable on November 30, 2021. If we raise cash proceeds of $200 million or more in one or more equity offerings, we are required to prepay AbbVie $25 million, which prepayment will reduce the amount payable to AbbVie on November 30, 2021, from $105 million to $80 million. We also will pay AbbVie an escalating, low single-digit royalty on worldwide net sales, on a product-by-product basis, of omaveloxolone and an identified list of existing Second-Generation Activators.  By reacquiring its rights, we were relieved from our obligations under the License Agreement and the Collaboration Agreement.  

We continue to incur significant research and development and other expenses related to our ongoing operations.  Despite contractual product development commitments and the potential to receive future paymentpayments from KKC, we anticipate that we will continue to incur losses for the foreseeable future, and we anticipate that our losses will increase as we continue our development of, and seek regulatory approval for, and potential commercialization of our product candidates.  If we do not successfully develop and obtain regulatory approval of our existing product candidates or any future product candidates and effectively manufacture, market, and sell any products that are approved, we may never generate revenue from product sales.  Furthermore, even if we do generate revenue from product sales, we may never again achieve or sustain profitability on a quarterly or annual basis.  Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.  Our failure to become and remain profitable could depress the market price of our Class A common stock and could impair our ability to raise capital, expand our business, diversify our product offerings, or continue our operations.

Financial Operations Overview

Revenue

Our revenue to date has been generated primarily from licensing fees received under our collaborative license agreements and reimbursements for expenses.  We currently have no approved products and have not generated any revenue from the sale of products to date.  In the future, we may generate revenue from product sales, royalties on product sales, reimbursements for collaboration services under the KKC Agreement,our current collaboration agreements, or license fees, milestones, or other upfront payments if we enter into any new collaborations or license agreements.  We expect that our future revenue will fluctuate from quarter to quarter for many reasons, including the uncertain timing and amount of any such payments and sales.

Our license and milestone revenue has been generated primarily from the KKC Agreement, the AbbVie License Agreement, with AbbVie, and the AbbVie Collaboration Agreement with AbbVie and consists of upfront payments and milestone payments.  License revenue recorded with respect to the KKC Agreement, the AbbVie License Agreement, and the AbbVie Collaboration Agreement consists solely of the recognition of deferred revenue.  Under our revenue recognition policy, collaboration revenue associated with upfront, non-refundable license payments received under our license and collaboration agreements are deferred and recognized ratably over the expected term of the performance obligations under each agreement.  TheUnder the Reacquisition Agreement, we no longer have performance obligations under the AbbVie License Agreement and the AbbVie Collaboration Agreement with AbbVie were terminated under the Amended AbbVie Agreement.  The related remaining balance of deferred revenue for the License Agreement was fully recognized in 2017 and, as discussed below, the remaining deferred balance of $191.7 million related to the Collaboration Agreement will be terminated in the fourth quarter of 2019.  Based on existing collaboration agreements, weWe only expect to recognize revenue under the KKC Agreement, which extends through 2021.


Research and Development Expenses

The largest component of our total operating expenses has historically been our investment in research and development activities, including the clinical development of our product candidates.  From our inception through SeptemberJune 30, 2019,2020, we have incurred a total of $734.7$859.4 million in research and development expense, thea majority of which relates to the development of bardoxolone and omaveloxolone.  We expect our research and development expense to continue to increase in the future as we advance our product candidates through clinical trials and expand our product candidate portfolio.  The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming, and we consider the active management and development of our clinical pipeline to be crucial to our long-term success.  The actual probability of success for each product candidate and preclinical


program may be affected by a variety of factors, including the safety and efficacy data for product candidates, investment in the program, competition, manufacturing capability, and commercial viability.

Research and development expenses include:

 

expenses incurred under agreements with clinical trial sites that conduct research and development activities on our behalf;

 

expenses incurred under contract research agreements and other agreements with third parties;

 

employee and consultant-related expenses, which include salaries, benefits, travel, and stock-based compensation;

 

laboratory and vendor expenses related to the execution of preclinical and non-clinical studies and clinical trials;

 

the cost of acquiring, developing, manufacturing, and distributing clinical trial materials;

 

the cost of development, scale up, and process validation activities to support product registration; and

 

facilities, depreciation, and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance, and other supply costs.

Research and development costs are expensed as incurred.  Costs for certain development activities such as clinical trials are highly judgmental and are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and our clinical sites.

We base our expense accruals related to clinical trials on our estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and contract research organizations (CROs) that conduct and manage clinical trials on our behalf.  The financial terms of these agreements vary from contract to contract and may result in uneven payment flows.  Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones.  In accruing costs, we estimate the time period over which services will be performed and the level of effort to be expended in each period.  If we do not identify costs that we have begun to incur or if we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates.

To date, we have not experienced significantmaterial changes in our estimates of accrued research and development expenses after a reporting period.  However, due to the nature of estimates, we cannot assure you that we will not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical trials and other research activities.

Currently, KKC is not participating in the developmenthas allowed us to conduct clinical studies of bardoxolone in CTD-PAH, ADPKD, or othercertain rare forms of kidney diseases but is reimbursingin Japan and has reimbursed us the majority of the costs for our registrational trial in CKD caused by Alport syndromeCARDINAL study in Japan and is responsiblepaying for the costs forof a certain number of patients as the in-country caretaker in our registrational trial in ADPKDFALCON study in Japan.  OurWe reduced our expenses were reduced by $0.5$0.0 million and $0.3 million for KKC’s share of the studyCARDINAL costs for the ninesix months ended SeptemberJune 30, 2019.  2020 and 2019, respectively.


The following table summarizes our research and development expenses incurred:

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

Three Months Ended

June 30

 

 

Six Months Ended

June 30

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

(unaudited; in thousands)

 

 

(unaudited; in thousands)

 

Bardoxolone methyl

 

$

12,511

 

 

$

11,281

 

 

$

31,904

 

 

$

32,337

 

 

$

9,736

 

 

$

10,713

 

 

$

23,653

 

 

$

19,393

 

Omaveloxolone

 

$

5,999

 

 

 

6,817

 

 

 

17,478

 

 

 

14,105

 

 

 

8,313

 

 

 

5,676

 

 

 

14,942

 

 

 

11,479

 

RTA 901

 

$

560

 

 

 

62

 

 

 

1,616

 

 

 

328

 

 

 

750

 

 

 

719

 

 

 

1,961

 

 

 

1,055

 

RTA 1701

 

$

452

 

 

 

621

 

 

 

1,433

 

 

 

2,125

 

 

 

479

 

 

 

653

 

 

 

1,874

 

 

 

982

 

Other research and development expenses

 

$

12,757

 

 

 

8,363

 

 

 

35,517

 

 

 

23,084

 

 

 

17,505

 

 

 

11,793

 

 

 

42,006

 

 

 

22,759

 

Total research and development expenses

 

$

32,279

 

 

$

27,144

 

 

$

87,948

 

 

$

71,979

 

 

$

36,783

 

 

$

29,554

 

 

$

84,436

 

 

$

55,668

 


 

The program-specific expenses summarized in the table above include costs that we directly allocate to our product candidates.  Our other research and development expenses include employee-related expenses for research and development functionssalaries, benefits, stock-based compensation and preclinical, research, and discovery costs, which we do not allocate on a program-specific basis.

General and Administrative Expenses

General and administrative expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance, and human resource functions.  Other general and administrative expenses include personnel expense, facility-related costs, professional fees, accounting and legal services, depreciation expense, other external services, and expenses associated with obtaining and maintaining our intellectual property rights.

We anticipate that our general and administrative expenses will increase in the future as we increaseprepare for our headcount to support our continued research and development and potential commercialization of our product candidates.  We have also incurred, and anticipate incurring in the future, increased expenses associated with being a public company, including exchange listing and SEC requirements, director and officer insurance premium, legal, audit and tax fees, compliance with the Sarbanes-Oxley Act, regulatory compliance programs, and investor relations costs.  Based on positive results from CARDINALAdditionally, if and MOXIe, and subject to discussions withwhen we believe the first regulatory authorities,approval of one of our product candidates appears likely, we plan to proceed with the submission of regulatory filings for marketing approval in the United States and internationally. Accordingly, we have increased and anticipate continued increasesan increase in payroll and related expenses as a result of our preparation for commercial operations, especially for the sales and marketing of our product candidates.

Other Income (Expense), Net

Other income represents(expense) includes interest and gains earned on our cash and cash equivalents, which include money market funds.interest expense on term loans, amortization of debt issuance costs, imputed interest on long term payables, loss on extinguishment of debt, foreign currency exchange gains and losses, gains and losses on sales of assets, and non-cash interest expense on liability related to the sale of future royalties.

(Benefit from) Provision for Taxes on Income

Provision for taxes on income consists of net loss, taxed at federal tax rates and adjusted for certain permanent differences.  We maintain a full valuation allowance against our net deferred tax assets.  Changes in this valuation allowance also affect the tax provision.


Results of Operations

Comparison of the Three Months Ended SeptemberJune 30, 20192020 and 20182019 (unaudited)

The following table sets forth our results of operations for the three months ended SeptemberJune 30:

 

2019

 

 

2018

 

 

Change $

 

 

Change %

 

 

2020

 

 

2019

 

 

Change $

 

 

Change %

 

 

(in thousands)

 

 

(in thousands)

 

Collaboration revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License and milestone

 

$

7,898

 

 

$

4,766

 

 

$

3,132

 

 

 

66

 

 

$

1,169

 

 

$

7,813

 

 

$

(6,644

)

 

 

(85

)

Other revenue

 

 

344

 

 

 

409

 

 

 

(65

)

 

 

(16

)

 

 

1,904

 

 

 

20

 

 

 

1,884

 

 

**

 

Total collaboration revenue

 

 

8,242

 

 

 

5,175

 

 

 

3,067

 

 

 

59

 

 

 

3,073

 

 

 

7,833

 

 

 

(4,760

)

 

 

(61

)

Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

32,279

 

 

 

27,144

 

 

 

5,135

 

 

 

19

 

 

 

36,783

 

 

 

29,554

 

 

 

7,229

 

 

 

24

 

General and administrative

 

 

14,283

 

 

 

7,486

 

 

 

6,797

 

 

 

91

 

 

 

16,600

 

 

 

11,706

 

 

 

4,894

 

 

 

42

 

Depreciation

 

 

258

 

 

 

105

 

 

 

153

 

 

 

146

 

 

 

284

 

 

 

232

 

 

 

52

 

 

 

22

 

Total expenses

 

 

46,820

 

 

 

34,735

 

 

 

12,085

 

 

 

35

 

 

 

53,667

 

 

 

41,492

 

 

 

12,175

 

 

 

29

 

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income

 

 

1,311

 

 

 

1,094

 

 

 

217

 

 

 

20

 

Interest expense

 

 

(2,389

)

 

 

(2,360

)

 

 

(29

)

 

 

(1

)

Total other income (expense)

 

 

(1,078

)

 

 

(1,266

)

 

 

188

 

 

 

15

 

Other income (expense), net

 

 

(16,990

)

 

 

(701

)

 

 

(16,289

)

 

**

 

Loss before taxes on income

 

 

(39,656

)

 

 

(30,826

)

 

 

(8,830

)

 

 

(29

)

 

 

(67,584

)

 

 

(34,360

)

 

 

(33,224

)

 

 

(97

)

Provision for taxes on income

 

 

38

 

 

 

9

 

 

 

29

 

 

 

322

 

(Benefit from) provision for taxes on income

 

 

(3

)

 

 

20

 

 

 

(23

)

 

 

(115

)

Net loss

 

$

(39,694

)

 

$

(30,835

)

 

$

(8,859

)

 

 

(29

)

 

$

(67,581

)

 

$

(34,380

)

 

$

(33,201

)

 

 

(97

)

** Percentage not meaningful

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Collaboration Revenue

License and milestone revenue represented approximately 96%38% and 92%100% of total revenue for the three months ended SeptemberJune 30, 2020 and 2019, respectively, and 2018, respectively.consisted primarily of the recognition of deferred revenue.  License and milestone revenue increaseddecreased by $3.1$6.6 million or 66%85% during the three months ended SeptemberJune 30, 20192020, compared to the three months ended SeptemberJune 30, 2018.  A reduction2019, primarily due to the Reacquisition Agreement in October 2019, which ended our performance obligations under the AbbVie Collaboration Agreement and resulted in the writing off of the related remaining deferred revenue balance, after which no further revenue was recognized.  Total revenue of $1.2 million was recognized during the three months ended June 30, 2020 from deferred revenue related to an adjustment in the calculation of a regulatory milestone revenue included as variable consideration in the transaction price under the KKC Agreement was recognized in the prior year period. Since we did not have a similar event in the current period, the

Other revenue increased by comparison.

Other revenue was immaterial$1.9 million for the three months ended SeptemberJune 30, 2019 and 2018.2020, compared to the three months ended June 30, 2019. The increase was primarily due to $1.6 million in revenue recognized for reimbursements of expenses from KKC.  

The following table summarizes the sources of our revenue for the three months ended SeptemberJune 30:

 

 

2020

 

 

2019

 

 

 

(in thousands)

 

License and milestone

 

 

 

 

 

 

 

 

AbbVie Collaboration Agreement

 

$

 

 

$

6,644

 

KKC Agreement

 

 

1,169

 

 

 

1,169

 

Total license and milestone

 

 

1,169

 

 

 

7,813

 

Other revenue

 

 

1,904

 

 

 

20

 

Total collaboration revenue

 

$

3,073

 

 

$

7,833

 

Expenses

The following table summarizes our expenses, as a percentage of total expenses, for the three months ended June 30:

 

 

2019

 

 

2018

 

 

 

(in thousands)

 

License and milestone

 

 

 

 

 

 

 

 

Collaboration Agreement

 

$

6,717

 

 

$

6,717

 

KKC Agreement

 

 

1,181

 

 

 

(2,951

)

Other

 

 

 

 

 

1,000

 

Total license and milestone

 

 

7,898

 

 

 

4,766

 

Other revenue

 

 

344

 

 

 

409

 

Total collaboration revenue

 

$

8,242

 

 

$

5,175

 

 

 

2020

 

 

% of Total

Expenses

 

 

2019

 

 

% of Total

Expenses

 

 

 

 

(in thousands)

 

 

Research and development

 

$

36,783

 

 

 

68

%

 

$

29,554

 

 

 

71

%

 

General and administrative

 

 

16,600

 

 

 

31

%

 

 

11,706

 

 

 

28

%

 

Depreciation

 

 

284

 

 

 

1

%

 

 

232

 

 

 

1

%

 

Total expenses

 

$

53,667

 

 

 

 

 

 

$

41,492

 

 

 

 

 

 


Research and Development Expenses

Research and development expenses increased by $5.1$7.2 million, or 19%24%, for the three months ended SeptemberJune 30, 2019,2020, compared to the three months ended SeptemberJune 30, 2018.2019.  The increase was primarily due to $3.3$8.5 million in increased personnel and equity compensationpersonnel-related expenses related to supportthe growth of our development activities $0.9and accelerated recognition of stock-based compensation expense from employees who entered into consulting agreements at the termination of employment; $1.6 million in increased medical affairs and other research activities, and $0.7 million caused by two components: increased manufacturing costs to support product registration and startup activities for FALCON and the extension trials for our registrational programs, which were offset by a decrease in clinical study expenses related to stopping the CATALYST study and its extension study; and $2.3 million in decreased clinical expenses due to fully enrolled and completed studies.medical affairs expenses.

Research and development expenses, as a percentage of total expenses, was 69%68% and 78%71% for the three months ended SeptemberJune 30, 20192020 and 2018,2019, respectively.  The decrease of 9%3% was primarily due to a proportionately larger increase in general and administrative expenses, such aswhich includes personnel and equitystock-based compensation expenses and rent and office expenses to support growth in our development and commercial readiness activities.

General and Administrative Expenses

General and administrative expenses increased by $6.8$4.9 million, or 91%42%, for the three months ended SeptemberJune 30, 2019,2020, compared to the three months ended SeptemberJune 30, 2018.  2019. The increase was primarily due to $3.3$6.1 million in increased personnel and equitystock-based compensation expenses, $1.7offset by a decrease of $0.6 million in increased rentmarketing and office expenses to support growth in our development activities, $0.3 million in increased professional fees related to audit, legal, and tax-related services, and $0.9 million in increase patent fees.commercialization expenses.


 

General and administrative expenses, as a percentage of total expenses, was 31% and 22%28%, for the three months ended SeptemberJune 30, 20192020 and 2018,2019, respectively.  The increase of 9%3% was primarily due to a proportionately larger increase in general and administrative expenses, compared to research and development expenses.

DepreciationOther Income (Expense), Net

Depreciation wasOther income (expense), net increased by $0.2$16.3 million or 146%, for the three months ended SeptemberJune 30, 2019,2020, compared to the three months ended SeptemberJune 30, 2018,2019.  The increase was primarily due to increases$11.2 million from loss on debt extinguishment, $3.2 million of additional interest expense attributable to additional borrowings under the Term B Loan drawn in propertyDecember 2019 and equipmentthe payable due to collaborator related to growththe Reacquisition Agreement in personnelOctober 2019, and office space.

Investment Income

Investment$1.2 million in decreased investment income increased by $0.2 million, or 20%, for the three months ended September 30, 2019, compared to the three months ended September 30, 2018, due to investment anddeclining interest income earned on higher average balances of cash and cash equivalents.rates.

Interest Expenses

Interest expense during the three months ended September 30, 2019 was consistent with the three months ended September 30, 2018.

(Benefit from) Provision for Taxes on Income

Provision forBenefit from taxes on income was immaterial for the three months ended SeptemberJune 30, 20192020 and 2018.2019.


Comparison of the NineSix Months Ended SeptemberJune 30, 2020 and 2019 and 2018 (unaudited)

The following table sets forth our results of operations for the ninesix months ended SeptemberJune 30:

 

2019

 

 

2018

 

 

Change $

 

 

Change %

 

 

2020

 

 

2019

 

 

Change $

 

 

Change %

 

 

(in thousands)

 

 

(in thousands)

 

Collaboration revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License and milestone

 

$

23,437

 

 

$

44,452

 

 

$

(21,015

)

 

 

(47

)

 

$

2,338

 

 

$

15,539

 

 

$

(13,201

)

 

 

(85

)

Other revenue

 

 

409

 

 

 

685

 

 

 

(276

)

 

 

(40

)

 

 

2,088

 

 

 

64

 

 

 

2,024

 

 

**

 

Total collaboration revenue

 

 

23,846

 

 

 

45,137

 

 

 

(21,291

)

 

 

(47

)

 

 

4,426

 

 

 

15,603

 

 

 

(11,177

)

 

 

(72

)

Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

87,948

 

 

 

71,979

 

 

 

15,969

 

 

 

22

 

 

 

84,436

 

 

 

55,668

 

 

 

28,768

 

 

 

52

 

General and administrative

 

 

36,027

 

 

 

24,802

 

 

 

11,225

 

 

 

45

 

 

 

37,387

 

 

 

21,744

 

 

 

15,643

 

 

 

72

 

Depreciation

 

 

659

 

 

 

311

 

 

 

348

 

 

 

112

 

 

 

562

 

 

 

401

 

 

 

161

 

 

 

40

 

Total expenses

 

 

124,634

 

 

 

97,092

 

 

 

27,542

 

 

 

28

 

 

 

122,385

 

 

 

77,813

 

 

 

44,572

 

 

 

57

 

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income

 

 

4,812

 

 

 

1,787

 

 

 

3,025

 

 

 

169

 

Interest expense

 

 

(7,199

)

 

 

(3,773

)

 

 

(3,426

)

 

 

(91

)

Loss on extinguishment of debt

 

 

 

 

 

(1,007

)

 

 

1,007

 

 

 

100

 

Other income (expense)

 

 

7

 

 

 

 

 

 

7

 

 

 

100

 

Total other income (expense)

 

 

(2,380

)

 

 

(2,993

)

 

 

613

 

 

 

20

 

Other income (expense), net

 

 

(20,804

)

 

 

(1,301

)

 

 

(19,503

)

 

**

 

Loss before taxes on income

 

 

(103,168

)

 

 

(54,948

)

 

 

(48,220

)

 

 

(88

)

 

 

(138,763

)

 

 

(63,511

)

 

 

(75,252

)

 

 

(118

)

Provision for taxes on income

 

 

60

 

 

 

15

 

 

 

45

 

 

 

300

 

(Benefit from) provision for taxes on income

 

 

(22,243

)

 

 

23

 

 

 

(22,266

)

 

**

 

Net loss

 

$

(103,228

)

 

$

(54,963

)

 

$

(48,265

)

 

 

(88

)

 

$

(116,520

)

 

$

(63,534

)

 

$

(52,986

)

 

 

(83

)

** Percentage not meaningful

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration Revenue

License and milestone revenue represented approximately 98%53% and 100% of total revenue for eachthe six months ended June 30, 2020, and 2019, respectively, and consisted primarily of the nine months ended September 30, 2019 and 2018.recognition of deferred revenue.  License and milestone revenue decreased by $21.0$13.2 million or 47%, for85% during the ninesix months ended SeptemberJune 30, 2019,2020, compared to the ninesix months ended SeptemberJune 30, 2018.  Additional2019, primarily due to the Reacquisition Agreement in October 2019, which ended our performance obligations under the AbbVie Collaboration Agreement and resulted in the writing off of the related remaining deferred revenue balance, after which no further revenue was recognized.  Total revenue of $2.3 million was recognized during the six months ended June 30, 2020 from deferred revenue related to variable consideration that was included in the transaction price under the KKC Agreement was recognized in the prior year period.  Since we did not have a similar event in the current period, the revenue decreased by comparison.

Other revenue decreasedincreased by $0.3$2.0 million or 40%, duringfor the ninesix months ended SeptemberJune 30, 2019,2020, compared to the ninesix months ended SeptemberJune 30, 2018,2019. The increase was primarily due to a decrease$1.6 million in revenue recognized for reimbursements of expenses from KKC for expenses incurred.KKC.  


The following table summarizes the sources of our revenue for the ninesix months ended SeptemberJune 30:

 

 

2020

 

 

2019

 

 

 

(in thousands)

 

License and milestone

 

 

 

 

 

 

 

 

AbbVie Collaboration Agreement

 

$

 

 

$

13,214

 

KKC Agreement

 

 

2,338

 

 

 

2,325

 

Total license and milestone

 

 

2,338

 

 

 

15,539

 

Other revenue

 

 

2,088

 

 

 

64

 

Total collaboration revenue

 

$

4,426

 

 

$

15,603

 

Expenses

The following table summarizes our expenses, as a percentage of total expenses, for the six months ended June 30:

 

 

2019

 

 

2018

 

 

 

(in thousands)

 

License and milestone

 

 

 

 

 

 

 

 

Collaboration Agreement

 

$

19,931

 

 

$

19,931

 

KKC Agreement

 

 

3,506

 

 

 

23,521

 

Other

 

 

 

 

 

1,000

 

Total license and milestone

 

 

23,437

 

 

 

44,452

 

Other revenue

 

 

409

 

 

 

685

 

Total collaboration revenue

 

$

23,846

 

 

$

45,137

 

 

 

2020

 

 

% of Total

Expenses

 

 

2019

 

 

% of Total

Expenses

 

 

 

(in thousands)

 

Research and development

 

$

84,436

 

 

 

69

%

 

$

55,668

 

 

 

71

%

General and administrative

 

 

37,387

 

 

 

30

%

 

 

21,744

 

 

 

28

%

Depreciation

 

 

562

 

 

 

1

%

 

 

401

 

 

 

1

%

Total expenses

 

$

122,385

 

 

 

 

 

 

$

77,813

 

 

 

 

 

Research and Development Expenses

Research and development expenses increased by $16.0$28.8 million, or 22%52%, for the ninesix months ended SeptemberJune 30, 2019,2020, compared to the ninesix months ended SeptemberJune 30, 2018.  2019.  The increase was primarily due to $8.6$21.7 million in increased personnel and equity compensationpersonnel-related expenses related to supportthe growth of our development


activities $3.3and accelerated recognition of stock-based compensation expense as a result of the death of an executive and employees who entered into consulting agreements at the termination of employment; $9.9 million in increased medical affairs and other research activitiesto support our registrational trials, and $3.6 million caused by two components: increased manufacturing costs to support product registration and startup activities for FALCONincreased clinical, clinical pharmacology, and the extension trials fortoxicity study expenses to support our registrational programs, as well as our RTA 901 and RTA 1701 programs, which were offset by a decrease in clinical study expenses related to stopping the CATALYST study and its extension study; and $2.7 million in decreased clinical expenses due to fully enrolledmedical affairs and completed studies.research expenses.

Research and development expenses, as a percentage of total expenses, was 71%69% and 74%71% for the ninesix months ended SeptemberJune 30, 20192020 and 2018,2019, respectively.  The decrease of 3% is2% was primarily due to a proportionately larger increase in general and administrative expenses, such aswhich includes personnel and equitystock-based compensation expenses and rent and office expenses to support growth in our development and commercial readiness activities.

General and Administrative Expenses

General and administrative expenses increased by $11.2$15.6 million, or 45%72%, for the ninesix months ended SeptemberJune 30, 2019,2020, compared to the ninesix months ended SeptemberJune 30, 2018.  2019.  The increase was primarily due to $8.4$14.2 million in increased personnel and equitystock-based compensation expenses, $3.8$0.6 million in increased rentinsurance expenses, and office expenses to support growth in our development activities, and $0.9$0.5 million in increased professional fees related to audit, legal,marketing and tax-related services, which were offset by a decrease in sublicense fees of $2.5 million and other expenses related to the achievement of a KKC milestone in 2018.commercialization expenses.

General and administrative expenses, as a percentage of total expenses, was 29%30% and 26%28%, for the ninesix months ended SeptemberJune 30, 2020 and 2019, and 2018, respectively.  The 3% increase of 2% was primarily due to a proportionately larger increase in general and administrative expenses, compared to research and development expenses.

DepreciationOther Income (Expense), Net

Depreciation wasOther income (expense), net increased by $0.3$19.5 million or 112%, for the ninesix months ended SeptemberJune 30, 2019,2020, compared to the ninesix months ended SeptemberJune 30, 2018,2019.  The increase was primarily due to increases in property and equipment related to growth in personnel and office space.

Investment Income

Investment income increased by $3.0$11.2 million or 169%, for the nine months ended September 30, 2019, compared to the nine months ended September 30, 2018, due to investment andfrom loss on debt extinguishment, $6.7 million of additional interest income earned on higher average balances of cash and cash equivalents.

Interest Expense

Interest expense increased by $3.4 million, or 91%, for the nine months ended September 30, 2019, compared to the nine months ended September 30, 2018, dueattributable to additional borrowings under our Restatedthe Term B Loan drawn in December 2019 and the payable due to collaborator related to the Reacquisition Agreement entered in June 2018.October 2019,and $1.0 million in decreased investment income due to declining interest rates.


(Benefit from) Provision for Taxes on Income

Provision forBenefit from taxes on income was immaterial for the nine months ended September 30, 2019 and 2018.

Cash-based Operating Expenses (non-GAAP) for the Three and Nine Months Ended September 30, 2019 and 2018 (unaudited)

Total expenses (GAAP) were $46.8 million and $124.6increased by $22.2 million for the three and ninesix months ended SeptemberJune 30, 2019, respectively,2020, compared to $34.7 million and $97.1 million for the three and ninesix months ended SeptemberJune 30, 2018, respectively. Our cash-based operating expenses (a non-GAAP measure calculated as total expenses, less stock-based compensation expense and depreciation expense) were $41.2 million and $109.9 million2019.  The increase was primarily due to a tax refund we have filed for under the three and nine months ended September 30, 2019, respectively, compared to $31.9 million and $89.0 million forprovisions of the three and nine months ended September 30, 2018, respectively.


We expect our cash-based operating expenses to continue to increase in the future as we advance bardoxolone and omaveloxolone through ongoing and future clinical trials, scale manufacturing for registrational and validation purposes, advance other product candidates into mid and later stage clinical trials, expand our product candidate portfolio, increase both our research and development and administrative personnel, and plan for commercialization of our product candidates.  

We believe cash-based operating expenses, in addition to GAAP financial measures, provides a meaningful measure of our ongoing business and operating performance, by allowing investors to analyze our financial results similarly to how management analyzes our financial results by viewing period expense totals more indicative of effort directly expended to advance the business and our product candidates. The table below reconciles cash-based operating expenses to total expenses as reported on the Unaudited Consolidated Statements of Operations:

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

(in thousands)

 

Total expenses - GAAP

$

46,820

 

 

$

34,735

 

 

$

124,634

 

 

$

97,092

 

Stock-based compensation expense

 

(5,380

)

 

 

(2,745

)

 

 

(14,090

)

 

 

(7,783

)

Depreciation

 

(258

)

 

 

(105

)

 

 

(659

)

 

 

(311

)

Cash-based operating expenses - Non-GAAP

$

41,182

 

 

$

31,885

 

 

$

109,885

 

 

$

88,998

 

For additional information about our non-GAAP financial measure, see “—Non-GAAP Financial Measure”.CARES Act.

Liquidity and Capital Resources

Since our inception, we have funded our operations primarily through collaboration and license agreements, the sale of preferred and common stock, secured loans, and secured loans.the sale of future royalties.  Through SeptemberJune 30, 2019,2020, we have raised gross cash proceeds of $476.6 million through the sale of convertible preferred stock and $780.0 million from payments under license and collaboration agreements. We also obtained $402.3$944.7 million in net proceeds from our IPOinitial public offering, follow-on offerings, and follow-on offeringsthe sale of our Class A common stock under the Purchase Agreement, and $77.2$299.0 million in net proceeds from the sale of future royalties under the Development Agreement.  We also obtained $151.6 million in net proceeds from our Amended Restated Loan Agreement.Agreement, which we paid off in June 2020.  We have not generated any revenue from the sale of any products.  As of SeptemberJune 30, 2019,2020, we had available cash and cash equivalents of approximately $240.1$610.4 million.  Our cash and cash equivalents are invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.

Cash Flows

The following table sets forth the primary sources and uses of cash for each of the ninesix months ended September 30 (unaudited):June 30:

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

(in thousands)

 

 

(in thousands)

 

Net cash (used in) provided by:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating activities

 

$

(101,776

)

 

$

(46,286

)

 

$

(237,107

)

 

$

(61,441

)

Investing activities

 

 

(2,420

)

 

 

(370

)

 

 

(384

)

 

 

(2,092

)

Financing activities

 

 

6,555

 

 

 

292,061

 

 

 

183,586

 

 

 

6,192

 

Net change in cash and cash equivalents

 

$

(97,641

)

 

$

245,405

 

 

$

(53,905

)

 

$

(57,341

)

 

 


Operating Activities

Net cash used in operating activities was $101.8$237.1 million for the ninesix months ended SeptemberJune 30, 2019,2020, consisting primarily of a net loss of $103.2$116.5 million adjusted for non-cash items including stock-based compensation expense of $14.1$34.1 million, loss on extinguishment of debt of $11.2 million, depreciation and amortization expense of $1.7$4.7 million, and a net increase in operating assets and liabilities of $171.3 million.  The significant items in the change in operating assets that impacted our use of cash in operations were an increase in income tax receivable of $22.2 million and a decrease in payable to collaborators of $150.0 million for a payment made on June 30, 2020 under the Reacquisition Agreement.

Net cash used in operating activities was $61.4 million for the six months ended June 30, 2019, consisting primarily of a net loss of $63.5 million adjusted for non-cash items including stock-based compensation expense of $8.7 million, depreciation and amortization expense of $1.1 million, and a net decrease in operating assets and liabilities of $14.4$7.7 million.  The significant items in the change in operating assets that impacted our use of cash in operations include increases in accrued direct research and other current and long-term liabilities of $11.4$9.8 million primarily due to activities directly related to our clinical trials and otherpersonnel-related activities, to support our registrational trials, an increase in prepaid expenses and other current assets of $1.9$3.2 million due to increases in prepaid subscriptions and insurance premiums, and decreases in amounts earned or due from collaboration agreements of $0.9 million and deferred revenue of $23.4$15.5 million.  The decrease in deferred revenue is due to the ratable recognition of revenue over the expected term of the performance obligations under our collaboration agreements with AbbVie and KKC, which resulted in recognition of $23.4$15.5 million of license and milestone revenue.revenue.


Net cash used in operating activities was $46.3 million for the nine months ended September 30, 2018, consisting primarily of a net loss of $55.0 million adjusted for non-cash items including stock-based compensation expense of $7.8 million, depreciation and amortization expense of $0.9 million, loss on extinguishment of debt of $1.0 million, and a net increase in operating assets and liabilities of $1.0 million.  The significant items in the change in operating assets and liabilities include an increase in prepaid expenses, other current assets, and other assets of $1.3 million primarily due to receivables from KKC related to reimbursement for expenses incurred, an increase in accrued direct research and other current and long-term liabilities of $10.8 million due clinical trial activities, and a decrease in deferred revenue of $13.5 million.  The decrease in deferred revenue is due to the ratable recognition of revenue over the expected term of the performance obligations under our collaboration agreements with AbbVie and KKC, which resulted in recognition of $43.5 million of license and milestone revenue, offset by the achievement of the regulatory milestone of $30 million related to the KKC Agreement, which was recognized as deferred revenue.Investing Activities

Investing Activities

Net cash used in investing activities of $2.4$0.4 million and $2.1 million for the nine six months ended SeptemberJune 30, 2020 and 2019, respectively, were primarily due to capital expenditures in connection with an expansion of our office space and purchasespurchase of property and equipment.

Net cash used in investing activities for the nine months ended September 30, 2018 was not significant.

Financing Activities

Net cash provided by financing activities of $6.6was $183.6 million for the ninesix months ended SeptemberJune 30, 2019 were2020, primarily due to stock option exercises.$55.4 million and $293.6 million in funding received from the Purchase Agreement and Development Agreement with BXLS, respectively, and $1.8 million from options exercised, offset by $167.2 million to pay off our Term Loans.

Net cash provided by financing activities of $292.1was $6.2 million for the ninesix months ended SeptemberJune 30, 20182019, were primarily due to net proceeds of $232.8 million from our follow-on public offering and $57.7 million from our Restated Loan Agreement.option exercises.

Operating Capital Requirements

To date, we have not generated any revenue from product sales.  We do not know when or whether we will generate any revenue from product sales.  We do not expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and commercialize one or more of our current or future product candidates.  We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any approved products.  We are subject to all the risks related to the development and commercialization of novel therapeutics, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.  We continue to incur additional costs associated with operating as a public company.  We anticipate that we will need substantial additional funding in connection with our continuing operations.


On June 24, 2020, we closed on the Development Agreement and Purchase Agreement, each dated June 10, 2020, under which certain Blackstone entities paid us an aggregate of $350.0 million in exchange for future royalties on bardoxolone and an aggregate of 340,793 shares of our Class A common stock at $146.72 per share.

On June 24, 2020, we paid off our Term Loans with Oxford Finance LLC and Silicon Valley Bank, which included payments for principal of $155.0 million, prepayment fees of $5.4 million, exit fees of $6.7 million, and accrued and unpaid interest of $1.0 million.

On March 27, 2020, the United States enacted the CARES Act.  Under its provisions, for the six months ended June 30, 2020, we recognized a tax benefit and receivable of $22.1 million associated with the ability to carryback an applicable prior year’s net operating losses to a preceding year to generate a refund.  

On November 18, 2019, we closed a follow-on underwritten public offering of 2,760,000 shares of our Class A common stock for gross proceeds of $505.1 million.  Net proceeds to us from the offering were approximately $491.9 million, after deducting underwriting discounts and commissions and offering expenses.

On October 15, 2019, we entered into athe Lease Agreement, relating to the lease of approximately 327,400 square feet of office and laboratory space located in Plano, Texas.  The term of the Lease is estimated to commence mid-2022, when construction is completed, and continue for 16 years, with up to 10 years of extension at our option.  The initial annual base rent will be determined based on the project cost, subject to an initial annual cap of approximately $13.3 million, which may increase in certain circumstances.  Beginning in the third lease year, the base rent will increase 1.95% per annum each year.  In addition to the annual base rent, we will pay for taxes, insurance, utilities, operating expenses, assessments under private covenants, maintenance and repairs, certain capital repairs and replacements, and building management fees.

On October 9, 2019, we and AbbVie entered into the Amended AbbVieReacquisition Agreement pursuant to which we reacquired the development, manufacturing, and commercialization rights concerning itsour proprietary Nrf2 activator product platform originally licensed to AbbVie in the AbbVie License Agreement and the AbbVie Collaboration Agreement.  In exchange for such rights, we will pay AbbVie $330$330.0 million, of which $75$100.0 million is payable onwas paid as of December 8,31, 2019, $150$150.0 million is payablewas paid on June 30, 2020, and $105$80.0 million is payable on November 30,


2021.  If we raise cash proceeds of $200 million or more in one or more equity offerings, we are required to prepay AbbVie $25 million, which prepaymentWe will reduce the amount payable to AbbVie on November 30, 2021, from $105 million to $80 million. We also will pay AbbVie an escalating, low single-digit royalty on worldwide net sales, on a product-by-product basis, of omaveloxolone and an identified list of existing Second-Generation Activators.  As a result of entering into the Amended AbbVie Agreement, while we are finalizing our assessment of the accounting for the transaction, we anticipate that we will recognize a charge in the fourth quarter of 2019, which will reflect the repurchase of the rights and the termination of the future obligations on which the Company has deferred revenue recorded as of September 30, 2019.certain next-generation Nrf2 activators.  The termination of our deferred revenue balance will not have an impact on our cash flow.

On October 9, 2019, we entered into the Amendment with the Lenders, which amended the Restated Loan Agreement entered into among us and the Lenders on June 14, 2018.  Under the Amendment, the Term B Loan availability was increased from $45 million to $75 million and the availability period was increased from within 30 days to 60 days after the achievement of the one of two milestones. As one of the milestones was achieved on October 14, 2019, the availability period will end on December 13, 2019.  If we borrow under the Term B Loan, we expect to incur additional related interest expense.  As of September 30, 2019, the current portion of the loan is $5.3 million, which is based on the interest-only payment period under the Term A Loan. If we draw the Term B Loan, the interest-only period will extend through June 1, 2021, and the current portion of the loan will be $0 until July 1, 2020.

On July 27, 2018, we closed a follow-on underwritten public offering of 3,450,000 shares of its Class A common stock for gross proceeds of $248.4 million.  Net proceeds to us from the offering were approximately $232.8 million, after deducting underwriting discounts and commissions and offering expenses.

On June 14, 2018, we amended and restated our Loan Agreement.  Under our Restated Loan Agreement, the Term A Loan was increased from $20.0 million to $80.0 million, of which Reata borrowed an additional $60.0 million on June 14, 2018, which resulted in an outstanding principal balance of $80.0 million under the Term A Loan at June 14, 2018.  

In November 2017, we entered into an at-the-market equity offering sales agreement with Stifel, Nicolaus & Company, Incorporated, that established a program pursuant to which theyit may offer and sell up to $50.0 million of ourits Class A common stock from time to time in at-the-market transactions as statedtransactions.  In November 2019, we suspended the program in the prospectus supplement filedconnection with the SEC pursuant to Rule 424(b)(5), dated as of November 9, 2017.2019 equity offering, which remains suspended until we notify Stifel otherwise.  To date, no sales have been made under theour at-the-market offering program.

Under the Amended AbbVie Agreement, we have significantly increased our current obligations, but we believe that our current cash, along with our access to additional equity or debt funding, will enable us to meet our current obligations through December 31, 2020.  Our longer term liquidity requirements will require us to raise additional capital.capital, such as through additional equity, debt, or royalty financings or collaboration arrangements.  Our future capital requirements will depend on many factors, including the receipt of milestones under theour KKC Agreement and the timing of our expenditures related to clinical trials.  We believe our existing cash and cash equivalents will be sufficient to enable us to fund our operations through the end of 2023.  However, we anticipate opportunistically raising additional capital before that time through equity offerings, collaboration or license agreements, additional debt, or royalty financings in order to maintain adequate capital reserves.  In addition, we may choose to raise additional capital at any time for the further development of our existing product candidates and may also need to raise additional funds sooner to pursue other development activities related to additional product candidates.  Decisions about the timing or nature of any financing will be based on, among other things, our


perception of our liquidity and of the market opportunity to raise equity, debt, or debt.royalty financing.  Additional securities may include common stock, preferred stock, or debt securities.  We may explore strategic collaborations or license arrangements for certainany of our earlier stage assets, including RTA 901 and RTA 1701.product candidates.  If we do explore any arrangements, there can be no assurance that any agreement will be reached, and we may determine to cease exploring a potential transaction for any or all of the assets at any time.  If an agreement is reached, there can be no assurance that any such transaction would provide us with a material amount of additional capital resources.

Until we can generate a sufficient amount of revenue from our product candidates, if ever, we expect to finance future cash needs through public or private equity or debt offerings, commercial loans, royalty financings, and collaboration or license transactions, and royalty financings.transactions.  The outbreak of COVID-19 has caused significant disruption of global financial markets, which may reduce our ability to access capital, which could negatively affect our liquidity.  Additional capital may not be available on reasonable terms, if at all.  If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back, or discontinue the development or commercialization of one or more of our product candidates.  If we raise additional funds through the issuance of additional equity or debt securities, it could result in dilution to our existing stockholders or increased fixed payment obligations, and any such securities may have rights senior to those of our common stock.  If we incur indebtedness or obtain royalty financing, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell, or license intellectual property rights, and other operating restrictions that could adversely affect our ability to conduct our business, and any such debt or royalty financing could be secured by some or all of our assets.  If we sell royalty interests, we may be required to make significant royalty payments for an extended period of time.  Any of these events could significantly harm our business, financial condition, and prospects.  For a description of the numerous risks and uncertainties associated with product development and raising additional capital, see “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2018 2019and in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.March 31, 2020, under “Part II, Item 1A. Risk Factors.”

Our forecast of the period through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors.  We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.  Our future funding requirements, both near- and long-term, will depend on many factors, including, but not limited to:

 

the scope, rate of progress, results, and cost of our clinical trials, preclinical testing, and other activities related to the development of our product candidates;

 

the number and characteristics of product candidates that we pursue;

 

the costs of development efforts for our product candidates that are not subject to reimbursement from our collaborator;


 

the costs necessary to obtain regulatory approvals, if any, for our product candidates in the United States and other jurisdictions, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where approval is obtained;

 

the continuation of our existing collaboration with KKC and entry into new collaborations and the receipt of any collaboration payments;

 

the time and unreimbursed costs necessary to commercialize products in territories in which our product candidates are approved for sale;

 

the revenue from any future sales of our products for which we are entitled to a profit share, royalties, and milestones;

 

the level of reimbursement or third-party payor pricing available to our products;

 

the costs of obtaining third-party commercial supplies of our products, if any, manufactured in accordance with regulatory requirements;

 

the costs associated with any potential loss or corruption of our information or data in a cyberattack on our computer system;systems or those of our suppliers, vendors, or collaborators who store or transmit our data;

 

the costs associated with being a public company; and


 

any additional costs we incur associated with the COVID-19 pandemic; and

the costs we incur in the filing, prosecution, maintenance, and defense of our patent portfolio and other intellectual property rights.

If we cannot expand our operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition, and results of operations could be materially adversely affected.

Contractual Obligations and Commitments

As of SeptemberJune 30, 2019,2020, there have been no material changes, outside of the ordinary course of business, in our outstanding contractual obligations from those disclosed within “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, as contained in our Annual Report on Form 10-K for year ended December 31, 2018.2019, except for those discussed below.

Below are our contractual obligations as of SeptemberJune 30, 20192020 (unaudited):

 

 

Payments due by period

 

 

Payments due by period

 

 

Less than

1 year

 

 

1 to 3

years

 

 

4 to 5

years

 

 

Total

 

 

Less than

1 year

 

 

1 to 3

years

 

 

4 to 5

years

 

 

Total

 

 

(in thousands)

 

 

(in thousands)

 

Operating lease obligations(1)

 

$

3,336

 

 

$

2,424

 

 

$

 

 

$

5,760

 

 

$

3,787

 

 

$

5,918

 

 

$

 

 

$

9,705

 

Outstanding secured term loan

 

 

6,666

 

 

 

55,556

 

 

 

17,778

 

 

 

80,000

 

Payable to collaborators

 

 

 

 

 

80,000

 

 

 

 

 

 

80,000

 

Total contractual obligations

 

$

10,002

 

 

$

57,980

 

 

$

17,778

 

 

$

85,760

 

 

$

3,787

 

 

$

85,918

 

 

$

 

 

$

89,705

 

(1)

Total minimum future lease payments for the Plano build-to-suit lease have not commenced as of June 30, 2020. Therefore, such payments are not included in the consolidated financial statement, as we do not yet control the underlying assets.  The lease is expected to commence mid-2022 with initial lease term of 16 years.

The terms of the Development Agreement require us to pay potential future royalty payments based on product development success. The above table excludes such obligations as the amount and timing of such obligations are unknown or uncertain, which are further described in Note 5, Liability Related to Sale of Future Royalties, to Consolidated Financial Statements contained in this Quarterly Report on Form 10-Q.

 


Clinical Trials

As of SeptemberJune 30, 2019,2020, we have several on-going clinical trials in various stages.  Under agreements with various CROs and clinical trial sites, we incur expenses related to clinical trials of our product candidates and potential other clinical candidates.  The timing and amounts of these disbursements are contingent upon the achievement of certain milestones, patient enrollment, and services rendered or as expenses are incurred by the CROs or clinical trial sites.  Therefore, we cannot estimate the potential timing and amount of these payments, and they have been excluded from the table above.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles.  The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements.  On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue recognition, accrued research and development expenses, income taxes, and stock-based compensation.  We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.  Actual results may differ from these estimates under different assumptions or conditions.

Our significant accounting policies are described in Note 2 of Part I, Item 1 of this Quarterly Report on Form 10-Q and in Part I, Item 7, “Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2018.2019. During the quarterthree months ended March 31, 2019June 30, 2020, we adopted Topic 842.entered into the Development Agreement with an affiliate of BXLS.  As a result, we recorded a liability related to sale of this adoption, we updatedfuture royalties that are based on our Leases policies.current estimate of future royalties expected to be paid over the estimated term of the Development Agreement and non-cash interest expense over the estimated term of the Development Agreement.  There have been no other changes to our critical accounting policies and estimates since our Annual Report on Form 10-K for the year ended December 31, 2018.2019.

Off-Balance Sheet Arrangements

Since our inception, we have not had any relationships with unconsolidated organizations or financial partnerships, such as structured finance or special purpose entities, that would have been established for the purpose of facilitating off-balance sheet arrangements, and we have not engaged in any other off-balance sheet arrangements, as defined in the rules and regulations of the SEC.


Recent Accounting Pronouncements

For a discussion of recent accounting pronouncements, please see Note 2 of Notes to Consolidated Financial Statements contained in this Quarterly Report on Form 10-Q.

Non-GAAP Financial Measures

In addition to the U.S. GAAP financial measures, this Quarterly Report on Form 10-Q includes cash-based operating expenses, a non-GAAP financial measure, which the Company defines as total expenses excluding stock-based compensation expense and depreciation expense.  A reconciliation of this non-GAAP financial measure to its most directly comparable U.S. GAAP financial measure is included in “—Results of Operations—Cash-based Operating Expenses (non-GAAP) for the three and nine months ended September 30, 2019 (unaudited)” above.  

Non-GAAP financial measures should be considered in addition to, not in isolation or as a substitute for, U.S. GAAP financial measures.  In addition, our non-GAAP financial measure may differ from similarly named measures used by other companies.  You should carefully evaluate our non-GAAP financial measure, the adjustments included in our non-GAAP financial measure, and the reasons we consider it appropriate for analysis supplemental to our GAAP information. This non-GAAP financial measure has important limitations as an analytical tool due to the exclusion of some but not all items that affect the most directly comparable GAAP financial measure.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are exposed to market risks in the ordinary course of our business.  These market risks are principally limited to interest rate fluctuations.  We had cash and cash equivalents of $240.1$610.4 million at SeptemberJune 30, 2019,2020, consisting primarily of funds in operating cash accounts.  The primary objective of our investment activities is to preserve principal and liquidity while maximizing income without significantly increasing risk.  We do not enter into investments for trading or speculative purposes.  Due to the short-term nature of our investment portfolio, we do not believe an immediate increase of 100 basis points in interest rates would have a material effect on the fair market value of our portfolio, and accordingly we do not expect a sudden change in market interest rates to affect materially our operating results or cash flows.

We also have interest rate exposure as a result of our Term A Loan.  As of September 30, 2019, the outstanding principal amount of our Term A Loan was $80.0 million.  Our Term A Loan bears interest at a floating per annum rate calculated as 7.79% plus the greater of the 30-day U.S. Dollar LIBOR rate reported in The Wall Street Journal or 1.91%, with a minimum rate of 9.7% and a maximum rate of 12.29%.  Changes in the U.S. Dollar LIBOR rate may therefore affect our interest expense associated with the Term A Loan.  An increase of 100 basis points in interest rates would increase expense by approximately $0.8 million annually based on the amounts currently outstanding and would not materially affect our results of operations.

We contract with research, development, and manufacturing organizations and investigational sites globally.  Generally, these contracts are denominated in United States dollars.  However, we may be subject to fluctuations in


foreign currency rates in connection with agreements not denominated in United States dollars.  We do not hedge our foreign currency exchange rate risk.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of SeptemberJune 30, 2019.2020.  The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act (15 U.S.C. 78a et seq.) is recorded, processed, summarized, and reported, within the time periods specified in the SEC’s rules and forms.  Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing


similar functions, as appropriate to allow timely decisions regarding required disclosure.  Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.  Based on the evaluation of our disclosure controls and procedures as of SeptemberJune 30, 2019,2020, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.  

Changes in Internal Control Over Financial Reporting

There have been no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f)15d-15(f) promulgated under the Exchange Act, during the three months ended SeptemberJune 30, 2019,2020, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II — OTHER INFORMATION

We are not currently subject to any material legal proceedings.

Item 1A. Risk Factors.

In addition to other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the risk factors and other cautionary statements described under the heading “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2018, 2019, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019,March 31, 2020, which could materially affect our businesses, financial condition, or future results.  Additional risks and uncertainties currently unknown to us, or that we currently deem to be immaterial, also may materially adversely affect our business, financial condition, or future results.  There have been no material changes in our risk factors from those described in the Annual Report on Form 10-K for the year ended December 31, 2018 2019 and the Quarterly Report on Form 10-Q for the quarter ended June 30, 2019.March 31, 2020.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Unregistered Sales of Equity SecuritiesNone, except as previously reported on a Current Report on Form 8-K.

None.

Item 3. Defaults Upon Senior Securities.

None.


Item 4. Mine Safety Disclosures.

None.

Item 5. Other Information.

None.


Item 6. Exhibits.

 

Exhibit

Number

 

Description

 

 

 

  3.1

 

Thirteenth Amended and Restated Certificate of Incorporation, dated May 11, 2016 (incorporated by reference to Exhibit 3.7 to the Company’s Form S-1 (File No. 333-208843), filed with the SEC on May 16, 2016).

 

 

 

��  3.2

 

Second Amended and Restated Bylaws, dated as of December 7, 2016 (incorporated by reference to Exhibit 3.1 to the Company’s Form 8-K (File No. 001-37785), filed with the SEC on December 7, 2016).

 

 

 

  10.1+*10.1*

 

IndemnificationFirst Amendment to Lease Agreement, by anddated as of May 27, 2020.

  10.2†#*

Common Stock Purchase Agreement between the Company and Manmeet S. SoniBXLS V – River L.P, dated August 28, 2019.as of June 10, 2020.

 

 

 

  10.2+*10.3†#*

 

EmploymentDevelopment and Commercialization Funding Agreement by and between the Company and Manmeet S. SoniBXLS V – River L.P, dated August 28, 2019.

  10.3+*

Restricted Stock Unit Agreement.as of June 10, 2020.

 

 

 

  10.4+*

 

NoticeFourth Amended and Restated Non-Employee Director Compensation Policy, dated as of Grant of Restricted Stock Units for employees.June 10, 2020.

 

 

 

  10.5#10.5+

 

AmendedIndemnification Agreement by and Restated License Agreement,between the Company and Martin W. Edwards, dated as of October 9, 2019August 3, 2020 (incorporated by reference to Exhibit 10.1 to the Company’sCompany's Form 8-K (File No. 001-37785), filed with the SEC on October 10, 2019).

  10.6

First Amendment to Amended and Restated Loan and Security Agreement, dated as of October 9, 2019 (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K (File No. 001-37785), filed with the SEC on October 10, 2019).

  10.7

Lease Agreement, dated as of October 15, 2019 (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K (File No. 001-37785), filed with the SEC on October 16, 2019).

  10.8

Expansion Agreement, dated as of October 15, 2019 (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K (File No. 001-37785), filed with the SEC on October 16, 2019).

  10.9#

Fifth Supplement to Exclusive License and Supply Agreement, dated August 22, 2019, between Reata Pharmaceuticals, Inc. and Kyowa Kirin Co., Ltd (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K (File No. 001-37785), filed with the SEC on August 22, 2019).

  10.10#

Sixth Supplement to Exclusive License and Supply Agreement, dated August 22, 2019, between Reata Pharmaceuticals, Inc. and Kyowa Kirin Co., Ltd (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K (File No. 001-37785), filed with the SEC on August 22, 2019)July 31, 2020).

 

 

 

  31.1*

 

Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

  31.2*

 

Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

  32.1**

 

Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

  32.2**

 

Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

101.INS*

 

Inline XBRL Instance Document

 

 

 

101.SCH*

 

Inline XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL*

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF*

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB*

 

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE*

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

*

Filed herewith.

**

Furnished herewith.

+

Indicates management contract or compensatory plan.

#

Confidential information hasCertain exhibits and schedules have been omitted from this Exhibit pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule or exhibit will be furnished to the Securities and Exchange Commission regulations.upon request.

#

Information in this exhibit identified by brackets is confidential and has been excluded pursuant to Item 601(b)(10)(iv) of Regulation S-K because it is not material and would likely cause competitive harm to the Company if publicly disclosed.An unredacted copy of this exhibit will be furnished to the Securities and Exchange Commission on a supplemental basis upon request.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Date: November 12, 2019August 10, 2020

REATA PHARMACEUTICALS, INC.

 

 

 

 

 

By:

 

/s/ J. Warren Huff

 

Name:

 

J. Warren Huff

 

Title:

 

Chief Executive Officer and President

 

 

 

By:

 

/s/ Manmeet S. Soni

 

Name:

 

Manmeet S. Soni

 

Title:

 

Chief Operating Officer, Chief Financial Officer, and Executive Vice President

 

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