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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended June 30, 2022

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 001-37553

 

REGENXBIO Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

 

47-1851754

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

9804 Medical Center Drive

Rockville, MD

 

20850

(Address of principal executive offices)

 

(Zip Code)

(240) 552-8181

(Registrant’s telephone number, including area code)

Not Applicable

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

 

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

 

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

RGNX

The Nasdaq Global Select 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, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

Accelerated filer

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

Emerging growth company

 

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

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

As of July 27, 2022, there were 43,229,971 shares of the registrant’s common stock, par value $0.0001 per share, issued and outstanding.

 

 

 


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REGENXBIO INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2022

TABLE OF CONTENTS

 

 

 

PART I—FINANCIAL INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Financial Statements (Unaudited)

 

3

 

 

Consolidated Balance Sheets as of June 30, 2022 and December 31, 2021

 

3

 

 

Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2022 and 2021

 

4

 

 

Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2022 and 2021

 

5

 

 

Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2022 and 2021

 

6

 

 

Notes to Consolidated Financial Statements

 

7

Item 2.

 

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

 

22

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

31

Item 4.

 

Controls and Procedures

 

31

 

 

 

 

 

 

 

PART II—OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

33

Item 1A.

 

Risk Factors

 

33

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

33

Item 3.

 

Defaults Upon Senior Securities

 

33

Item 4.

 

Mine Safety Disclosures

 

33

Item 5.

 

Other Information

 

33

Item 6.

 

Exhibits

 

34

Signatures

 

35

 

 

 


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INFORMATION REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “assume,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would” or by variations of such words or by similar expressions. We have based these forward-looking statements on our current expectations and assumptions and analyses in light of our experience and our perception of historical trends, current conditions and expected future developments, as well as other factors we believe are appropriate under the circumstances. However, whether actual results and developments will conform with our expectations and predictions is subject to a number of risks, uncertainties, assumptions and other important factors, including, but not limited to:

 

our ability to establish and maintain development partnerships, including our collaboration with AbbVie to develop and commercialize RGX-314;

 

our ability to obtain and maintain regulatory approval of our product candidates and the labeling for any approved products;

 

the timing of enrollment, commencement and completion and the success of our clinical trials, including the timing and commencement of our AFFINITY DUCHENNE clinical trial;

 

the timing of commencement and completion and the success of preclinical studies conducted by us and our development partners;

 

the timely development and launch of new products;

 

the scope, progress, expansion and costs of developing and commercializing our product candidates;

 

our ability to obtain, maintain and enforce intellectual property protection for our product candidates and technology, and defend against third-party intellectual property-related claims;

 

our expectations regarding the development and commercialization of product candidates currently being developed by third parties that utilize our technology;

 

the impact of the COVID-19 pandemic on our business, operations and preclinical and clinical development timelines and plans;

 

our anticipated growth strategies;

 

our expectations regarding competition;

 

the anticipated trends and challenges in our business and the market in which we operate;

 

our ability to attract or retain key personnel;

 

the size and growth of the potential markets for our product candidates and the ability to serve those markets;

 

the rate and degree of market acceptance of any of our products that are approved;

 

our expectations regarding our expenses and revenue;

 

our expectations regarding the outcome of legal proceedings;

 

our expectations regarding regulatory developments in the United States and foreign countries; and

 

our ability to accurately predict how long our existing cash resources will be sufficient to fund our anticipated operating expenses.

1


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You should carefully read the factors discussed in the sections titled “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on Form 10-Q, our Annual Report on Form 10-K for the year ended December 31, 2021 and in our other filings with the U.S. Securities and Exchange Commission (the SEC) for additional discussion of the risks, uncertainties, assumptions and other important factors that could cause our actual results or developments to differ materially and adversely from those projected in the forward-looking statements. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on us or our businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially and adversely from those projected in the forward-looking statements. These forward-looking statements speak only as of the date of this report. Except as required by law, we disclaim any duty to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Available Information

Our principal offices are located at 9804 Medical Center Drive, Rockville, MD 20850, and our telephone number is (240) 552-8181. Our website address is www.regenxbio.com. The information contained in, or that can be accessed through, our website is not a part of, or incorporated by reference in, this Quarterly Report on Form 10-Q. We file annual, quarterly, and current reports, proxy statements, and other documents with the SEC under the Exchange Act. You may obtain any reports, proxy and information statements, and other information that we file electronically with the SEC at www.sec.gov.

You also may view and download copies of our SEC filings free of charge at our website as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. The information contained on, or that can be accessed through, our website will not be deemed to be incorporated by reference in, and is not considered part of, this Quarterly Report on Form 10-Q. Investors should also note that we use our website, as well as SEC filings, press releases, public conference calls and webcasts, to announce financial information and other material developments regarding our business. We use these channels, as well as any social media channels listed on our website, to communicate with investors and members of the public about our business. It is possible that the information that we post on our social media channels could be deemed material information. Therefore, we encourage investors, the media and others interested in our company to review the information that we post on our social media channels.

As used in this Quarterly Report on Form 10-Q, the terms “REGENXBIO,” “we,” “us,” “our” or the “Company” mean REGENXBIO Inc. and its subsidiaries, on a consolidated basis, unless the context indicates otherwise.

AAVIATE, ALTITUDE, ATMOSPHERE, NAV, REGENXBIO and the REGENXBIO logos are our registered trademarks. Any other trademarks appearing in this Quarterly Report on Form 10-Q are the property of their respective holders.

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Table of Contents

 

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements.

REGENXBIO INC.

CONSOLIDATED BALANCE SHEETS

(unaudited)

(in thousands, except per share data)

 

 

 

June 30, 2022

 

 

December 31, 2021

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

121,374

 

 

$

345,209

 

Marketable securities

 

 

281,588

 

 

 

112,230

 

Accounts receivable, net

 

 

37,500

 

 

 

32,439

 

Prepaid expenses

 

 

16,245

 

 

 

18,752

 

Other current assets

 

 

8,717

 

 

 

10,196

 

Total current assets

 

 

465,424

 

 

 

518,826

 

Marketable securities

 

 

279,073

 

 

 

391,907

 

Accounts receivable, net

 

 

2,034

 

 

 

2,262

 

Property and equipment, net

 

 

138,815

 

 

 

131,547

 

Operating lease right-of-use assets

 

 

60,163

 

 

 

60,904

 

Restricted cash

 

 

2,030

 

 

 

2,030

 

Other assets

 

 

5,905

 

 

 

6,428

 

Total assets

 

$

953,444

 

 

$

1,113,904

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

16,985

 

 

$

11,387

 

Accrued expenses and other current liabilities

 

 

47,014

 

 

 

76,111

 

Deferred revenue

 

 

6,636

 

 

 

3,333

 

Operating lease liabilities

 

 

2,832

 

 

 

1,752

 

Liability related to sale of future royalties

 

 

41,089

 

 

 

37,889

 

Total current liabilities

 

 

114,556

 

 

 

130,472

 

Operating lease liabilities

 

 

85,672

 

 

 

84,929

 

Liability related to sale of future royalties

 

 

114,171

 

 

 

133,460

 

Other liabilities

 

 

8,526

 

 

 

745

 

Total liabilities

 

 

322,925

 

 

 

349,606

 

Stockholders’ equity

 

 

 

 

 

 

 

 

Preferred stock; $0.0001 par value; 10,000 shares authorized, no shares issued

   and outstanding at June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Common stock; $0.0001 par value; 100,000 shares authorized at June 30, 2022

   and December 31, 2021; 43,171 and 42,831 shares issued and outstanding at

   June 30, 2022 and December 31, 2021, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

951,412

 

 

 

928,095

 

Accumulated other comprehensive loss

 

 

(14,763

)

 

 

(2,569

)

Accumulated deficit

 

 

(306,134

)

 

 

(161,232

)

Total stockholders’ equity

 

 

630,519

 

 

 

764,298

 

Total liabilities and stockholders’ equity

 

$

953,444

 

 

$

1,113,904

 

 

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

 

 

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Table of Contents

 

 

REGENXBIO INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License and royalty revenue

 

$

32,649

 

 

$

22,035

 

 

$

54,867

 

 

$

40,919

 

Total revenues

 

 

32,649

 

 

 

22,035

 

 

 

54,867

 

 

 

40,919

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenues

 

 

12,951

 

 

 

9,819

 

 

 

28,668

 

 

 

14,670

 

Research and development

 

 

61,008

 

 

 

45,882

 

 

 

116,635

 

 

 

85,604

 

General and administrative

 

 

20,832

 

 

 

18,425

 

 

 

43,150

 

 

 

36,263

 

Credit losses and other

 

 

391

 

 

 

135

 

 

 

474

 

 

 

650

 

Total operating expenses

 

 

95,182

 

 

 

74,261

 

 

 

188,927

 

 

 

137,187

 

Loss from operations

 

 

(62,533

)

 

 

(52,226

)

 

 

(134,060

)

 

 

(96,268

)

Other Income (Expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income from licensing

 

 

153

 

 

 

554

 

 

 

247

 

 

 

583

 

Investment income

 

 

1,061

 

 

 

399

 

 

 

1,860

 

 

 

979

 

Interest expense

 

 

(6,860

)

 

 

(6,366

)

 

 

(12,990

)

 

 

(13,068

)

Total other income (expense)

 

 

(5,646

)

 

 

(5,413

)

 

 

(10,883

)

 

 

(11,506

)

Loss before income taxes

 

 

(68,179

)

 

 

(57,639

)

 

 

(144,943

)

 

 

(107,774

)

Income Tax Benefit (Expense)

 

 

 

 

 

 

 

 

41

 

 

 

(4

)

Net loss

 

$

(68,179

)

 

$

(57,639

)

 

$

(144,902

)

 

$

(107,778

)

Other Comprehensive Income (Loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale securities, net

 

 

(2,813

)

 

 

113

 

 

 

(12,194

)

 

 

(895

)

Total other comprehensive income (loss)

 

 

(2,813

)

 

 

113

 

 

 

(12,194

)

 

 

(895

)

Comprehensive loss

 

$

(70,992

)

 

$

(57,526

)

 

$

(157,096

)

 

$

(108,673

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(1.58

)

 

$

(1.36

)

 

$

(3.37

)

 

$

(2.56

)

Weighted-average common shares outstanding, basic and diluted

 

 

43,111

 

 

 

42,510

 

 

 

43,028

 

 

 

42,170

 

 

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

 

 

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Table of Contents

 

 

REGENXBIO INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(unaudited)

(in thousands)

 

 

 

Three Months Ended June 30, 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balances at March 31, 2022

 

 

42,982

 

 

$

4

 

 

$

939,570

 

 

$

(11,950

)

 

$

(237,955

)

 

$

689,669

 

Vesting of restricted stock units, net of tax

 

 

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options, net of tax

 

 

186

 

 

 

 

 

 

1,507

 

 

 

 

 

 

 

 

 

1,507

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

10,335

 

 

 

 

 

 

 

 

 

10,335

 

Unrealized loss on available-for-sale securities, net

 

 

 

 

 

 

 

 

 

 

 

(2,813

)

 

 

 

 

 

(2,813

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(68,179

)

 

 

(68,179

)

Balances at June 30, 2022

 

 

43,171

 

 

$

4

 

 

$

951,412

 

 

$

(14,763

)

 

$

(306,134

)

 

$

630,519

 

 

 

 

Three Months Ended June 30, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balances at March 31, 2021

 

 

42,505

 

 

$

4

 

 

$

895,079

 

 

$

(1,368

)

 

$

(339,211

)

 

$

554,504

 

Exercise of stock options

 

 

50

 

 

 

 

 

 

275

 

 

 

 

 

 

 

 

 

275

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

9,992

 

 

 

 

 

 

 

 

 

9,992

 

Unrealized gain on available-for-sale securities, net

 

 

 

 

 

 

 

 

 

 

 

113

 

 

 

 

 

 

113

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(57,639

)

 

 

(57,639

)

Balances at June 30, 2021

 

 

42,555

 

 

$

4

 

 

$

905,346

 

 

$

(1,255

)

 

$

(396,850

)

 

$

507,245

 

 

 

 

Six Months Ended June 30, 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balances at December 31, 2021

 

 

42,831

 

 

$

4

 

 

$

928,095

 

 

$

(2,569

)

 

$

(161,232

)

 

$

764,298

 

Vesting of restricted stock units, net of tax

 

 

55

 

 

 

 

 

 

(284

)

 

 

 

 

 

 

 

 

(284

)

Exercise of stock options, net of tax

 

 

263

 

 

 

 

 

 

1,844

 

 

 

 

 

 

 

 

 

1,844

 

Issuance of common stock under employee

   stock purchase plan

 

 

22

 

 

 

 

 

 

622

 

 

 

 

 

 

 

 

 

622

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

21,135

 

 

 

 

 

 

 

 

 

21,135

 

Unrealized loss on available-for-sale securities, net

 

 

 

 

 

 

 

 

 

 

 

(12,194

)

 

 

 

 

 

(12,194

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(144,902

)

 

 

(144,902

)

Balances at June 30, 2022

 

 

43,171

 

 

$

4

 

 

$

951,412

 

 

$

(14,763

)

 

$

(306,134

)

 

$

630,519

 

 

 

 

Six Months Ended June 30, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balances at December 31, 2020

 

 

37,476

 

 

$

4

 

 

$

667,181

 

 

$

(360

)

 

$

(289,072

)

 

$

377,753

 

Issuance of common stock upon public offering,

   net of transaction costs of $14,194

 

 

4,899

 

 

 

 

 

 

216,059

 

 

 

 

 

 

 

 

 

216,059

 

Exercise of stock options

 

 

161

 

 

 

 

 

 

1,567

 

 

 

 

 

 

 

 

 

1,567

 

Issuance of common stock under employee

   stock purchase plan

 

 

19

 

 

 

 

 

 

627

 

 

 

 

 

 

 

 

 

627

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

19,912

 

 

 

 

 

 

 

 

 

19,912

 

Unrealized loss on available-for-sale securities, net

 

 

 

 

 

 

 

 

 

 

 

(895

)

 

 

 

 

 

(895

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(107,778

)

 

 

(107,778

)

Balances at June 30, 2021

 

 

42,555

 

 

$

4

 

 

$

905,346

 

 

$

(1,255

)