UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended December 31, 20202021

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

For the transition period from       to       .  

Commission file number 001-38042

 

ARROWHEAD PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

46-0408024

(State or other jurisdiction of incorporation)incorporation or organization)

 

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

177 E. Colorado Blvd, Suite 700

Pasadena, California 91105

(626) 304-3400

(Address and telephone number of principal executive offices)

 

Former name, former address, and former fiscal year, if changed since last report: N/A

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

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 Valuepar value $0.001 per share

 

ARWR

 

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”,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  

The number of shares of the registrant’s common stock outstanding as of February 1, 2021January 31, 2022 was 103,792,410.105,459,716.


 

 


 

 

 

Page(s)

PART I — FINANCIAL INFORMATION

 

 

 

ITEM 1. FINANCIAL STATEMENTS (unaudited)

1

 

 

Consolidated Balance Sheets

1

 

 

Consolidated Statements of Operations and Comprehensive Income (Loss)

2

 

 

Consolidated StatementStatements of Stockholders’ Equity

3

 

 

Consolidated Statements of Cash Flows

4

 

 

Notes to Consolidated Financial Statements

5

 

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS  

1517

 

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

2326

 

 

ITEM 4. CONTROLS AND PROCEDURES

2326

 

 

PART II — OTHER INFORMATION

2427

 

 

ITEM 1. LEGAL PROCEEDINGS

2427

 

 

ITEM 1A. RISK FACTORS

2427

 

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

2427

 

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

2427

 

 

ITEM 4. MINE SAFETY DISCLOSURES

2427

 

 

ITEM 5. OTHER INFORMATION

2427

 

 

ITEM 6. EXHIBITS

2528

 

 

SIGNATURE

2629

 

 

 


 

PART I. FINANCIAL INFORMATION

ITEM 1.

FINANCIAL STATEMENTS

Arrowhead Pharmaceuticals, Inc.

Consolidated Balance Sheets

(In thousands, except per share amounts)

 

(unaudited)

December 31, 2020

 

 

September 30, 2020

 

(unaudited)

December 31, 2021

 

 

September 30, 2021

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

$

139,921

 

 

$

143,583

 

$

91,587

 

 

$

184,434

 

Accounts receivable

 

9,002

 

 

 

845

 

 

150

 

 

 

10,255

 

Prepaid expenses

 

7,069

 

 

 

4,250

 

 

5,199

 

 

 

4,362

 

Other current assets

 

2,318

 

 

 

1,782

 

 

2,795

 

 

 

2,191

 

Marketable securities

 

86,012

 

 

 

85,020

 

 

126,010

 

 

 

126,728

 

Short term investments

 

79,394

 

 

 

86,890

 

 

112,537

 

 

 

56,627

 

TOTAL CURRENT ASSETS

 

323,716

 

 

 

322,370

 

 

338,278

 

 

 

384,597

 

Property and equipment, net

 

33,730

 

 

 

30,881

 

 

52,303

 

 

 

48,675

 

Intangible assets, net

 

14,938

 

 

 

15,363

 

 

13,238

 

 

 

13,663

 

Long term investments

 

110,855

 

 

 

137,487

 

 

217,572

 

 

 

245,595

 

Right-of-use assets

 

15,747

 

 

 

16,138

 

 

16,875

 

 

 

17,346

 

Other assets

 

265

 

 

 

265

 

 

273

 

 

 

272

 

TOTAL ASSETS

$

499,251

 

 

$

522,504

 

$

638,539

 

 

$

710,148

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

$

4,827

 

 

$

6,829

 

$

4,068

 

 

$

9,457

 

Accrued expenses

 

9,570

 

 

 

5,389

 

 

18,518

 

 

 

14,001

 

Accrued payroll and benefits

 

2,753

 

 

 

8,061

 

 

2,968

 

 

 

9,773

 

Lease liabilities

 

1,183

 

 

 

1,095

 

 

2,826

 

 

 

2,250

 

Deferred revenue

 

6,744

 

 

 

19,291

 

 

108,652

 

 

 

111,055

 

Other current liabilities

 

17

 

 

 

16

 

TOTAL CURRENT LIABILITIES

 

25,094

 

 

 

40,681

 

 

137,032

 

 

 

146,536

 

LONG-TERM LIABILITIES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Lease liabilities, net of current portion

 

19,685

 

 

 

20,044

 

 

22,489

 

 

 

23,295

 

Deferred revenue, net of current portion

 

106,458

 

 

 

131,495

 

TOTAL LONG-TERM LIABILITIES

 

19,685

 

 

 

20,044

 

 

128,947

 

 

 

154,790

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Arrowhead Pharmaceuticals, Inc. stockholders' equity:

 

 

 

 

 

 

 

Common stock, $0.001 par value; 145,000 shares authorized; 103,194 and 102,376 shares issued and outstanding as of December 31, 2020 and September 30, 2020, respectively

 

195

 

 

 

195

 

Arrowhead Pharmaceuticals, Inc. stockholders’ equity:

 

 

 

 

 

 

 

Common stock, $0.001 par value; 145,000 shares authorized; 104,798 and 104,327 shares issued and outstanding as of December 31, 2021 and September 30, 2021, respectively

 

197

 

 

 

197

 

Additional paid-in capital

 

978,655

 

 

 

965,410

 

 

1,080,035

 

 

 

1,053,386

 

Accumulated other comprehensive income (loss)

 

198

 

 

 

18

 

Accumulated other comprehensive income

 

(108

)

 

 

(69

)

Accumulated deficit

 

(524,576

)

 

 

(503,844

)

 

(707,564

)

 

 

(644,692

)

TOTAL STOCKHOLDERS’ EQUITY

 

454,472

 

 

 

461,779

 

 

372,560

 

 

 

408,822

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

499,251

 

 

$

522,504

 

$

638,539

 

 

$

710,148

 

 

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

 

 

 


Arrowhead Pharmaceuticals, Inc.

Consolidated Statements of Operations and Comprehensive Income (Loss)

(unaudited)

(In thousands, except per share amounts)

 

 

 

Three Months Ended December 31,

 

 

 

2020

 

 

2019

 

REVENUE

 

$

21,303

 

 

$

29,455

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

Research and development

 

 

36,555

 

 

 

23,374

 

General and administrative expenses

 

 

8,802

 

 

 

10,934

 

TOTAL OPERATING EXPENSES

 

 

45,357

 

 

 

34,308

 

OPERATING INCOME (LOSS)

 

 

(24,054

)

 

 

(4,853

)

OTHER INCOME (EXPENSE)

 

 

 

 

 

 

 

 

Interest income (expense), net

 

 

2,169

 

 

 

2,180

 

Other income (expense)

 

 

1,153

 

 

 

-

 

TOTAL OTHER INCOME (EXPENSE)

 

 

3,322

 

 

 

2,180

 

INCOME (LOSS) BEFORE INCOME TAXES

 

 

(20,732

)

 

 

(2,673

)

Provision for income taxes

 

 

-

 

 

 

-

 

NET INCOME (LOSS)

 

 

(20,732

)

 

 

(2,673

)

NET INCOME (LOSS) PER SHARE - BASIC

 

$

(0.20

)

 

$

(0.03

)

NET INCOME (LOSS) PER SHARE - DILUTED

 

$

(0.20

)

 

$

(0.03

)

Weighted average shares outstanding - basic

 

 

102,757

 

 

 

97,090

 

Weighted average shares outstanding - diluted

 

 

102,757

 

 

 

97,090

 

OTHER COMPREHENSIVE INCOME (LOSS), NET OF TAX:

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

180

 

 

 

196

 

COMPREHENSIVE INCOME (LOSS)

 

$

(20,552

)

 

$

(2,477

)

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


Arrowhead Pharmaceuticals, Inc.

Consolidated Statement of Stockholders’ Equity

(unaudited)

(In thousands, except per share amounts)

 

 

Common

Stock

 

 

Amount ($)

 

 

Additional

Paid-In

Capital

 

 

Accumulated Other

Comprehensive

Income (Loss)

 

 

Accumulated

Deficit

 

 

Non-controlling

Interest

 

 

Totals

 

Balance at September 30, 2019

 

 

95,506

 

 

$

187

 

 

$

664,086

 

 

$

(392

)

 

$

(419,291

)

 

$

(555

)

 

$

244,035

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

4,491

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,491

 

Exercise of stock options

 

 

472

 

 

 

1

 

 

 

3,001

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

3,002

 

Common stock - restricted stock units vesting

 

 

533

 

 

 

1

 

 

 

(1

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Common stock - issued for cash

 

 

4,600

 

 

 

5

 

 

 

250,473

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

250,478

 

Foreign currency translation adjustments

 

 

-

 

 

 

-

 

 

 

-

 

 

 

196

 

 

 

-

 

 

 

-

 

 

 

196

 

Net income (loss) for the three months ended December 31, 2019

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(2,673

)

 

 

-

 

 

 

(2,673

)

Balance at December 31, 2019

 

 

101,111

 

 

$

194

 

 

$

922,050

 

 

$

(196

)

 

$

(421,964

)

 

$

(555

)

 

$

499,529

 

 

 

Common

Stock

 

 

Amount ($)

 

 

Additional

Paid-In

Capital

 

 

Accumulated Other

Comprehensive

Income (Loss)

 

 

Accumulated

Deficit

 

 

Totals

 

Balance at September 30, 2020

 

 

102,376

 

 

$

195

 

 

$

965,410

 

 

$

18

 

 

$

(503,844

)

 

$

461,779

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

8,144

 

 

 

-

 

 

 

-

 

 

 

8,144

 

Exercise of stock options

 

 

538

 

 

 

-

 

 

 

5,101

 

 

 

-

 

 

 

-

 

 

 

5,101

 

Common stock - restricted stock units vesting

 

 

280

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Foreign currency translation adjustments

 

 

-

 

 

 

-

 

 

 

-

 

 

 

180

 

 

 

-

 

 

 

180

 

Net income (loss) for the three months ended December 31, 2020

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(20,732

)

 

 

(20,732

)

Balance at December 31, 2020

 

 

103,194

 

 

$

195

 

 

$

978,655

 

 

$

198

 

 

$

(524,576

)

 

$

454,472

 

 

 

Three Months Ended December 31,

 

 

 

2021

 

 

2020

 

REVENUE

 

$

27,439

 

 

$

21,303

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

Research and development

 

 

65,765

 

 

 

36,555

 

General and administrative expenses

 

 

24,995

 

 

 

8,802

 

TOTAL OPERATING EXPENSES

 

 

90,760

 

 

 

45,357

 

OPERATING INCOME (LOSS)

 

 

(63,321

)

 

 

(24,054

)

OTHER INCOME (EXPENSE)

 

 

 

 

 

 

 

 

Interest income, net

 

 

1,156

 

 

 

2,169

 

Other income (expense)

 

 

(707

)

 

 

1,153

 

TOTAL OTHER INCOME (EXPENSE)

 

 

449

 

 

 

3,322

 

INCOME (LOSS) BEFORE INCOME TAXES

 

 

(62,872

)

 

 

(20,732

)

Provision for income taxes

 

 

-

 

 

 

-

 

NET INCOME (LOSS)

 

 

(62,872

)

 

 

(20,732

)

NET INCOME (LOSS) PER SHARE - BASIC

 

$

(0.60

)

 

$

(0.20

)

NET INCOME (LOSS) PER SHARE - DILUTED

 

$

(0.60

)

 

$

(0.20

)

Weighted average shares outstanding - basic

 

 

104,534

 

 

 

102,757

 

Weighted average shares outstanding - diluted

 

 

104,534

 

 

 

102,757

 

OTHER COMPREHENSIVE INCOME (LOSS), NET OF TAX:

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(39

)

 

 

180

 

COMPREHENSIVE INCOME (LOSS)

 

$

(62,911

)

 

$

(20,552

)

 

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

 

 

 


Arrowhead Pharmaceuticals, Inc.

Consolidated Statements of Stockholders’ Equity

(unaudited)

(In thousands, except per share amounts)

 

 

Common

Stock

 

 

Amount ($)

 

 

Additional

Paid-In

Capital

 

 

Accumulated Other

Comprehensive

Income (Loss)

 

 

Accumulated

Deficit

 

 

Totals

 

Balance at September 30, 2020

 

 

102,376

 

 

$

195

 

 

$

965,410

 

 

$

18

 

 

$

(503,844

)

 

$

461,779

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

8,144

 

 

 

-

 

 

 

-

 

 

 

8,144

 

Exercise of stock options

 

 

538

 

 

 

-

 

 

 

5,101

 

 

 

-

 

 

 

-

 

 

 

5,101

 

Common stock - restricted stock units vesting

 

 

280

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Foreign currency translation adjustments

 

 

-

 

 

 

-

 

 

 

-

 

 

 

180

 

 

 

-

 

 

 

180

 

Net income (loss) for the three months ended December 31, 2020

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(20,732

)

 

 

(20,732

)

Balance at December 31, 2020

 

 

103,194

 

 

$

195

 

 

$

978,655

 

 

$

198

 

 

$

(524,576

)

 

$

454,472

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common

Stock

 

 

Amount ($)

 

 

Additional

Paid-In

Capital

 

 

Accumulated Other

Comprehensive

Income (Loss)

 

 

Accumulated

Deficit

 

 

Totals

 

Balance at September 30, 2021

 

 

104,327

 

 

$

197

 

 

$

1,053,386

 

 

$

(69

)

 

$

(644,692

)

 

$

408,822

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

24,504

 

 

 

-

 

 

 

-

 

 

 

24,504

 

Exercise of stock options

 

 

208

 

 

 

 

 

 

 

2,145

 

 

 

-

 

 

 

-

 

 

 

2,145

 

Common stock - restricted stock units vesting

 

 

263

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Foreign currency translation adjustments

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(39

)

 

 

-

 

 

 

(39

)

Net income (loss) for the three months ended December 31, 2021

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(62,872

)

 

 

(62,872

)

Balance at December 31, 2021

 

 

104,798

 

 

$

197

 

 

$

1,080,035

 

 

$

(108

)

 

$

(707,564

)

 

$

372,560

 

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


Arrowhead Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(unaudited)

(In thousands, except per share amounts)

 

 

Three Months Ended December 31,

 

 

Three Months Ended December 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(20,732

)

 

$

(2,673

)

 

$

(62,872

)

 

$

(20,732

)

Stock-based compensation

 

 

8,144

 

 

 

4,492

 

 

 

24,504

 

 

 

8,144

 

Depreciation and amortization

 

 

1,848

 

 

 

1,260

 

 

 

2,573

 

 

 

1,848

 

Amortization/(accretion) of note premiums

 

 

(302

)

 

 

177

 

Amortization/(accretion) of note premiums/discounts

 

 

(280

)

 

 

(302

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(8,157

)

 

 

(684

)

 

 

10,105

 

 

 

(8,157

)

Prepaid expenses and other current assets

 

 

(3,193

)

 

 

1,378

 

 

 

(1,181

)

 

 

(3,193

)

Deferred revenue

 

 

(12,547

)

 

 

(28,771

)

 

 

(27,439

)

 

 

(12,547

)

Accounts payable

 

 

(2,002

)

 

 

4,552

 

 

 

(5,389

)

 

 

(2,002

)

Accrued expenses

 

 

(1,126

)

 

 

(4,214

)

 

 

(2,290

)

 

 

(1,126

)

Other

 

 

(855

)

 

 

953

 

 

 

922

 

 

 

(855

)

NET CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES

 

 

(38,922

)

 

 

(23,530

)

 

 

(61,347

)

 

 

(38,922

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(4,271

)

 

 

(4,320

)

 

 

(5,778

)

 

 

(4,271

)

Proceeds from sale of marketable securities

 

 

34,429

 

 

 

13,600

 

Purchases of investments

 

 

(65,875

)

 

 

-

 

Proceeds from sale of investments

 

 

38,268

 

 

 

34,429

 

NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES

 

 

30,158

 

 

 

9,280

 

 

 

(33,385

)

 

 

30,158

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from the exercises of stock options

 

 

5,102

 

 

 

3,001

 

 

 

1,885

 

 

 

5,102

 

Proceeds from the issuance of common stock

 

 

-

 

 

 

250,477

 

NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES

 

 

5,102

 

 

 

253,478

 

 

 

1,885

 

 

 

5,102

 

NET INCREASE (DECREASE) IN CASH

 

 

(3,662

)

 

 

239,228

 

 

 

(92,847

)

 

 

(3,662

)

CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD

 

 

143,583

 

 

 

221,804

 

 

 

184,434

 

 

 

143,583

 

CASH AND CASH EQUIVALENTS AT END OF PERIOD

 

$

139,921

 

 

$

461,032

 

 

$

91,587

 

 

$

139,921

 

 

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

 

 


Arrowhead Pharmaceuticals, Inc.

Notes to Consolidated Financial Statements

(unaudited)

Unless otherwise noted, (1) the term “Arrowhead” refers to Arrowhead Pharmaceuticals, Inc., a Delaware corporation and its Subsidiaries, (2) the terms “Company,” “we,” “us,” and “our,” refer to the ongoing business operations of Arrowhead and its Subsidiaries, whether conducted through Arrowhead or a subsidiary of Arrowhead, (3) the term “Subsidiaries” refers to Arrowhead Madison Inc. (“Arrowhead Madison”) and Arrowhead Australia Pty Ltd (“Arrowhead Australia”), (4) the term “Common Stock” refers to Arrowhead’s Common Stock, par value $0.001 per share, (5) the term “Preferred Stock” refers to Arrowhead’s Preferred Stock, par value $0.001 per share, and (6) the term “Stockholder(s)” refers to the holders of ArrowheadArrowhead’s Common Stock.

     

NOTE 1. ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES

Nature of Business and Recent Developments

Arrowhead Pharmaceuticals, Inc. develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep and durable knockdown of target genes. RNA interference (“RNAi”) is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. The Company'sCompany’s pipeline includes ARO-APOC3 for hypertriglyceridemia, ARO-ANG3 for dyslipidemia, ARO-HSD for liver disease, ARO-ENaC for cystic fibrosis, ARO-HIF2 for renal cell carcinoma, ARO-LUNG2 as a candidate to treatARO-DUX4 for facioscapulohumeral muscular dystrophy, ARO-LUNG2 for chronic obstructive pulmonary disorder, (“COPD”) and ARO-COV for treatment for the current novel coronavirus that causes COVID-19 and other possible future pulmonary-borne pathogens.pathogens, ARO-C3 for complement mediated diseases and ARO-RAGE and ARO-MUC5AC for various muco-obstructive or inflammatory pulmonary conditions. ARO-HSD for liver disease was out-licensed to Glaxosmithkline Intellectual Property (No. 3) Limited ARO-JNJ1,(“GSK”) in November 2021.  ARO-XDH is being developed for uncontrolled gout under a collaboration agreement with Horizon Therapeutics Ireland DAC (“Horizon”). ARO-JNJ2 and ARO-JNJ3 are being developed for undisclosed liver-expressed targets under a collaboration agreement with Janssen Pharmaceuticals, Inc. (“Janssen”).  JNJ-75220795 (ARO-JNJ1) is being developed by Janssen as a potential treatment for patients with non-alcoholic steatohepatitis (NASH). ARO-AAT for liver disease associated with alpha-1 antitrypsin deficiency (“AATD”) was out-licensed to Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) in October 2020. JNJ3989JNJ-3989 (formerly referred to as ARO-HBV) for chronic hepatitis B virus was out-licensed to Janssen in October 2018.  Olpasiran (formerly referred to as AMG 890 or ARO-LPA) for cardiovascular disease was out-licensed to Amgen Inc. (“Amgen”) in 2016.

Arrowhead operates lab facilities in Madison, Wisconsin and San Diego, California, where the Company’s research and development activities, including the development of RNAi therapeutics, are based.take place. The Company’s principal executive offices are located in Pasadena, California.California.

During the first quarter of fiscal year 2021,2022, the Company continued to develop and advance its pipeline and partnered candidates.  The Company hosted a key opinion leader webinar oncandidates and expanded its cardiometabolic candidates, ARO-APOC3 and ARO-ANG3. The Company presented positive interim clinical data from AROAAT2002, an open-label Phase 2 clinical study of ARO-AAT,facilities to support the Company’s second-generation investigational RNAi therapeutic being developed as a treatment for the rare genetic liver disease associated with AATD.  The Company also announced positive clinical data on its cardiometabolic candidates, ARO-APOC3 and ARO-ANG3, at the American Heart Association (“AHA”) Scientific Session 2020.  Finally, the Company announced a collaboration with Takeda to co-develop and co-commercialize ARO-AAT for alpha-1 antitrypsin-associated liver disease.  See Note 2 for more information regarding the collaboration with Takeda.growing pipeline.  Several key recent developments include:

The Company’s partnered candidates under its collaboration agreements also continue to progress.  Janssen began dosing patients in a Phase 2b triple combination study called REEF-1, designed to enroll up to 450 patients with chronic hepatitis B infection. In connection with the start of this study, Arrowhead earned a $25.0 million milestone payment under the Company’s License Agreement with Janssen (“Janssen License Agreement”).  The Company is currently performing discovery, optimization and preclinical research and development for ARO-JNJ1, ARO-JNJ2 and ARO-JNJ3 for Janssen as part of the Company’s Research Collaboration and Option Agreement with Janssen (“Janssen Collaboration Agreement”).  Under the terms of the Janssen agreements taken together, the Company has received $175.0 million as an upfront payment, $75.0 million in the form of an equity investment by Johnson & Johnson Innovation-JJDC, Inc. (“JJDC”) in Arrowhead Common Stock, two $25.0 million milestone payments and may receive up to $1.6 billion in development and sales milestones payments for the Janssen License Agreement, and up to $1.9 billion in development and sales milestone payments for the 3 additional targets covered under the Janssen Collaboration Agreement.  The Company is further eligible to receive tiered royalties on product sales up to mid-teens under the Janssen License Agreement and up to low teens under the Janssen Collaboration Agreement.  

The Company’s collaboration agreement with Amgen for Olpasiran (previously referred to as AMG 890 or ARO-LPA), (the “Second Collaboration and License Agreement” or “Olpasiran Agreement”), continues to progress.  In July 2020, Amgen initiated a Phase 2 clinical study, which resulted in a $20.0 million milestone payment to the Company.  The Company has received $35.0 million in upfront payments, $21.5 million in the form of an equity investment by Amgen in the Company’s Common Stock, $30.0 million in milestone payments, and may receive up to an additional $400.0 million in remaining development, regulatory and sales milestone payments.  The Company is eligible to receive up to low double-digit royalties for sales of products under the Olpasiran Agreement.

i)

dosed the first patients in its PALISADE study, a phase 3 clinical study to evaluate the safety and efficacy of ARO-APOC3 in adults with familial chylomicronemia syndrome (FCS);

ii)

entered into an exclusive license agreement with GSK for ARO-HSD;

iii)

Janssen presented clinical data from REEF-1, a Phase 2b study of different combination regimens, including JNJ-73763989 (JNJ-3989), formerly called ARO-HBV, and/or JNJ-56136379 (JNJ-6379), and a nucleos(t)ide analog (NA) for the treatment of chronic hepatitis B virus infection (CHB);

iv)

filed for regulatory clearance to begin a Phase 1/2a study of ARO-C3;

v)

presented additional interim clinical data from AROHSD1001, AROAAT2002, and AROAPOC31001; and

vi)

completed the purchase of 13 acres of land in the Verona Technology Park in Verona, Wisconsin, which is planned to be the site of an approximately 140,000 square foot laboratory and office facility and entered into a lease agreement for a new 144,000 square foot laboratory and office facility in San Diego, California.  Both facilities will provide additional space to support the Company’s continued growth.

5


On October 7, 2020, the Company entered into an Exclusive License and Co-Funding Agreement with Takeda (the “Takeda License Agreement”).  Under the Takeda License Agreement, Takeda and the Company will co-develop the Company’s ARO-AAT program. Within the United States, ARO-AAT, if approved, will be co-commercialized under a 50/50 profit sharing structure.  Outside the United States, Takeda will lead the global commercialization strategy and receive an exclusive license to commercialize ARO-AAT with the Company eligible to receive tiered royalties of 20% to 25% on net sales.  In January 2021, the Company received $300.0 million as an upfront payment and is eligible to receive potential development, regulatory and commercial milestones of up to $740.0 million.  

The revenue recognition for these collaboration agreements is discussed further in Note 2 below.  

The Company is actively monitoring the ongoing COVID-19 pandemic. The financial results for the three months ended December 31, 20202021 were not significantly impacted by COVID-19. During fiscal year 2020,Operationally, the Company had temporarily pausedhas experienced delays in its earlier stage programs due to a shortage in non-human primates, which are critical to the Company’s preclinical programs. Additionally, the Company has experienced delays in enrollment in its two ARO-AAT studies, SEQUOIA and the ARO-AAT 2002 study, but resumed the process of screening and enrolling patients. During the pause in enrollment, patients already enrolled in these studies continued to be dosed per protocol and continued to come in for their follow up visits. Additional delays have occurred in the Company’s earlier stage programs, but the Company does not expect a material impact to any program’s anticipated timelines. Additionally, theclinical trials. The Company’s operations at its research and development facilities in Madison, Wisconsin and San Diego, California, and its corporate headquarters in Pasadena, California have continued to operate with limited impact, other than for enhanced safety measures, including work from home policies.policies and intermittent lab supply shortages. However, the Company cannot predict the impact the progression of COVID-19 will have on future financial and operational results due to a variety of factors, including the ability of the Company’s clinical sites to continue to enroll subjects, the ability of the Company’s suppliers to continue to operate, the continued good health and safety of the Company’s employees and ultimately the length and severity of the COVID-19 pandemic.

Liquidity

The Consolidated Financial Statements have been prepared in conformity with the accounting principles generally accepted in the United States of America (“GAAP”), which contemplate the continuation of the Company as a going concern.  Historically, the Company’s primary sourcesources of financing hashave been through the sale of its securities.securities and revenue from its licensing and collaboration agreements. Research and development activities have required significant capital investment since the Company’s inception. The Company expects its operationsinception and are expected to continue to require significant cash expenditure in the future, particularly as the Company’s pipeline of drug candidates and its headcount have both expanded significantly.  Additionally, significant capital investment to pursue its research and development goals, includingwill be required as the Company’s pipeline matures into later stage clinical trials, and related drug manufacturing.as well as with the Company’s plans to increase its internal manufacturing capabilities. 

At December 31, 2020,2021, the Company had $139.9$91.6 million in cash and cash equivalents (including $2.4$3.0 million in restricted cash), $79.4$112.5 million in short-term investments, $86.0$126.0 million in marketable securities and $110.9$217.6 million in long-term investments to fund operations.  During the three months ended December 31, 2020,2021, the Company’s cash and investments balance decreased by $36.8$65.7 million, which was primarily due to cash being used to fund the result of fundingCompany’s operations.

In total, the Company remains eligible for $6.2 billion in developmental, regulatory and sales milestones and various royalties on net sales from its researchlicensing and development operations.collaboration agreements.  The revenue recognition for these collaboration agreements is discussed further in Note 2 below.  

Summary of Significant Accounting Policies

There have been no changes to the significant accounting policies disclosed in the Company’s most recent Annual Report on Form 10-K.

Recent Accounting Pronouncements  

In November 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2018-18 Collaborative Arrangements (Topic 808). This update provides clarificationThere have been no recent accounting pronouncements that have significantly impacted this Quarterly Report on the interaction between Revenue Recognition (Topic 606) and Collaborative Arrangements (Topic 808) including the alignment of unit of account guidance between the two topics. ASU 2018-18 became effective for the Company on October 1, 2020 and did not have a material impact on its Consolidated Financial Statements.

In August 2018, the FASB issued ASU No. 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. The new standard requires that certain implementation costs for cloud computing arrangements are capitalized and amortized over the term of the associated hosted cloud computing arrangement service. Capitalized implementation costs are classified in prepaid expenses and other assets. The amortization of the capitalized asset is presentedForm 10-Q, beyond those disclosed in the same lineCompany’s most recent Annual Report on the statement of operations and comprehensive loss as the fees for the associated hosted cloud computing arrangement service and not included with depreciation or amortization expense related to property and equipment or intangible assets. Cash flows related to capitalized implementation costs are presented in cash flows used in operating activities. ASU 2018-15 became effective for the Company on October 1, 2020 and did not have a material impact on its Consolidated Financial Statements.  Form 10-K.

6



NOTE 2. COLLABORATION AND LICENSE AGREEMENTS

Amgen Inc.

On September 28, 2016, the Company entered into 2 Collaboration and License Agreements and a Common Stock Purchase Agreement with Amgen. Under one of the collaboration and license agreements (the “Secondand a common stock purchase agreement with Amgen. Under the Second Collaboration and License Agreement” orAgreement (the “Olpasiran Agreement”), Amgen has received a worldwide, exclusive license to Arrowhead’s novel RNAi Olpasiran (previously referred to as AMG 890 or ARO-LPA) program. These RNAi molecules are designed to reduce elevated lipoprotein(a), which is a genetically validated, independent risk factor for atherosclerotic cardiovascular disease. Under the otherprior collaboration and license agreement (the “First Collaboration and License Agreement” or the “ARO-AMG1 Agreement”), Amgen received an option to a worldwide, exclusive license for ARO-AMG1, an RNAi therapy for an undisclosed genetically validated cardiovascular target. InUnder both agreements, Amgen is wholly responsible for clinical development and commercialization. Under the terms of the agreements taken together, the Company has received $35.0 million in upfront payments, $21.5 million in the form of an equity investment by Amgen in the Company’s Common Stock, and $30.0 million in milestone payments, and may receive up to an additional $400.0 million in remaining development, regulatory and sales milestone payments. The Company is further eligible to receive up to low double-digit royalties for sales of products under the Olpasiran Agreement. In July 2019, Amgen informed the Company that it would not be exercising its option for an exclusive license for ARO-AMG1, and as such, there will be no further milestone or royalty payments under the ARO-AMG1 Agreement.    

The Company has evaluated these agreements in accordance with FASB Topics 808 – Collaboration Arrangements and 606 - Revenue for Contracts from Customers. The Company has substantially completed its performance obligations under the Olpasiran Agreement and the ARO-AMG1 Agreement. Future milestones and royalties achieved will be recognized in their entirety when earned. In July 2020, Amgen initiated a Phase 2 clinical study of Olpasiran, which resulted in a $20.0 million milestone payment to the Company. During the three months ended December 31, 20202021 and 2019,2020, the Company recognized $0 and $0 of revenue associated with its agreement with Amgen, respectively.As of December 31, 2020,2021, there were $0 in contract assets recorded as accounts receivable and $0 contract liabilities recorded as current deferred revenue on the Company’s Consolidated Balance Sheets.

Janssen Pharmaceuticals, Inc.

On October 3, 2018, the Company entered into the Janssena License Agreement (the “Janssen License Agreement”) and the Janssena Research Collaboration and Option Agreement (the “Janssen Collaboration Agreement”) with Janssen, part of the Janssen Pharmaceutical Companies of Johnson & Johnson.  The Company also entered into a Stock Purchase Agreementstock purchase agreement with JJDC (“JJDC Stock Purchase Agreement”) with JJDC..  Under the Janssen License Agreement, Janssen has received a worldwide, exclusive license to the Company’s JNJ-3989 (ARO-HBV) program, the Company’s third-generation subcutaneously administered RNAi therapeutic candidate being developed as a potential therapy for patients with chronic hepatitis B virus infection. Beyond the Company’s Phase 1/2 study of JNJ-3989 (ARO-HBV), which the Company was responsible for completing, Janssen is also wholly responsible for clinical development and commercialization of JNJ-3989.  Under the Janssen Collaboration Agreement, Janssen will be able to select three new targets against which Arrowhead will develop clinical candidates.  These candidates are subject to certain restrictions and do not include candidates that already were in the Company’s pipeline.  The Company will perform discovery, optimization and preclinical research and development, entirely funded by Janssen, which on its own or in combination with Janssen development work, is sufficient to allow the filing of a U.S. Investigational New Drug applicationApplication or equivalent, at which time Janssen will have the option to take an exclusive license. If the option is exercised, Janssen will be wholly responsible for clinical development and commercialization of each optioned candidate.  Under the terms of the agreements taken together, the Company has received $175.0 million as an upfront payment, $75.0 million in the form of an equity investment by JJDC in Arrowhead Common Stock under the JJDC Stock Purchase Agreement, and two $25.0milestone and option payments totaling $70.0 million, milestone payments, and the Company may receive up to $1.6 billion in development and sales milestones payments for the Janssen License Agreement, and up to $1.9 billion in development and sales milestone payments for the 3 additional targets covered under the Janssen Collaboration Agreement. The Company is further eligible to receive tiered royalties on product sales up to mid-teens under the Janssen License Agreement and up to low teens under the Janssen Collaboration Agreement on product sales.  Agreement.

The Company has evaluated these agreements in accordance with the new revenue recognition standard that became effectiveFASB Topics 808 – Collaboration Arrangements and 606 - Revenue for the Company on October 1, 2018.  The adoption of the new revenue standard did not have a material impact on the balances reported when evaluated under the superseded revenue standard.Contracts from Customers.  At the inception of these agreements, the Company has identified 1 distinct performance obligation.  Regarding the Janssen License Agreement, the Company determined that the key deliverables included the license and certain R&D services including the Company’s responsibility to complete the Phase 1/2 study of JNJ-3989 (ARO-HBV) and the Company’s responsibility to ensure certain manufacturing of JNJ-3989 (ARO-HBV) drug product is completed and delivered to Janssen (the “Janssen R&D Services”).  Due to the specialized and unique nature of these Janssen R&D Services and their direct relationship with the license, the Company determined that these deliverables represent one distinct bundle and, thus, one performance obligation.  The Company also determined that Janssen’s option to require the Company to develop up to three new targets is not a material right and, thus, not a performance obligation at the onset of the agreement.  The consideration for this option is accounted for separately.

7


The Company determined the transaction price totaled approximately $252.6$252.7 million, which includes the upfront payment, the premium paid by JJDC for its equity investment in the Company, the two $25.0 million milestone payments earnedrelated to JNJ-3989 (ARO-HBV), and estimated payments for reimbursable Janssen R&D servicesServices to be performed.  The Company has allocated the total $252.6$252.7 million initial transaction price to its one distinct performance obligation for the JNJ-3989 (ARO-HBV) license and the associated Janssen R&D Services.  This revenueThe Company has recognized this transaction price in its entirety as of September 30, 2021, as its performance obligations were substantially completed. Future milestones and royalties achieved will be recognized using a proportional performance method (based on actual costs incurred versus total estimated costs incurred) beginning in October 2018 and ending as the Company’s efforts in overseeing the Phase 1/2 clinical trial are completed.their entirety when earned.  During the three months ended December 31, 20202021 and 2019,2020, the Company recognized approximately $0 and $12.7 million and $28.8 million of Revenuerevenue associated with this performance obligation, respectively. As of December 31, 2020,2021, there were $0 in contract assets recorded as accounts receivable, and $6.7 million$0 of contract liabilities recorded as current deferred revenue on the Company’s Consolidated Balance Sheets.  The $6.7 million of current deferred revenue is driven by the upfront payment, the premium paid by JJDC for its equity investment in the Company, and the two $25.0 million milestone payments earned, net of revenue recognized to date.

The Company has begun to conduct its discovery, optimization and preclinical research and development of ARO-JNJ1,JNJ-75220795 (ARO-JNJ1), ARO-JNJ2 and ARO-JNJ3 under the Janssen Collaboration Agreement.  All costs and labor hours spent by the Company will be entirely funded by Janssen. During the three months ended December 31, 2021 and 2020, and 2019, the Company recognized $0 and $0.3 million and $0.7 million of Revenuerevenue associated with these efforts, respectively.As of December 31 2020,, 2021, there were $0.8 million$0 of contract assets recorded as accounts receivable and $0 of contract liabilities recorded as current deferred revenue on the Company’s Consolidated Balance Sheets.

Takeda Pharmaceuticals U.S.A., Inc.

On October 7, 2020, the Company entered into the Takedaan Exclusive License Agreementand Co-funding agreement (the “Takeda License Agreement”) with Takeda.  Under the Takeda License Agreement, Takeda and the Company will co-develop the Company’s ARO-AAT program, the Company’s second-generation subcutaneously administered RNAi therapeutic candidate being developed as a treatment for liver disease associated with alpha-1 antitrypsin deficiency. Within the United States, ARO-AAT, if approved, will be co-commercialized under a 50/50 profit sharing structure. Outside the United States, Takeda will lead the global commercialization strategy and will receive an exclusive license to commercialize ARO-AAT, withwhile the Company will be eligible to receive tiered royalties of 20% to 25% on net sales.  In January 2021, the Company received $300.0 million as an upfront payment and is eligible to receive potential development, regulatory and commercial milestones of up to $740.0 million.  

The Company has evaluated the Takeda License Agreement in accordance with the new revenue recognition requirements that became effectiveFASB Topics 808 – Collaborative Arrangements and 606 - Revenue for the Company on October 1, 2018. The adoption of the new revenue standard will not have a material impact on the balances reported when evaluated under the superseded revenue standard.Contracts from Customers. At the inception of the Takeda License Agreement, the Company has identified 1 distinct performance obligation.  The Company determined that the key deliverables included the license and certain R&D services including the Company’s responsibilities to complete the initial portion of the SEQUOIA study, to complete the ongoing Phase 2 AROAAT2002 study and to ensure certain manufacturing of ARO-AAT drug product is completed and delivered to Takeda (the “Takeda R&D Services”).  Due to the specialized and unique nature of these Takeda R&D services,Services and their direct relationship with the license, the Company determined that these deliverables represent 1 distinct bundle and, thus, one performance obligation.  Beyond the Takeda R&D Services, which are the responsibility of the Company, Takeda will be responsible for managing future clinical development and commercialization.commercialization outside the United States.  Within the United States, the Company will also participate in co-development and co-commercialization efforts and will co-fund these efforts with Takeda as part of the 50/50 profit sharing structure within the United States.  The Company will co-fund certainconsiders the collaborative activities, including the co-development and co-commercialization, to be a separate unit of the developmentaccount within Topic 808, and commercialization costs that Takeda manages, andas such, these co-funding amounts will be offset against amounts owed to Arrowhead, either from milestonesrecorded as Research and Development Expenses or royalties earned, or profits earned under the 50/50 profit sharing structure for U.S. commercialization.General and Administrative Expenses, as appropriate.

The Company determined the initial transaction price totaled approximately $300.0 million, which includes the upfront payment.  The Company will excludehas excluded any future estimated milestones royalties, or profit-sharing paymentsroyalties from this transaction price to date.  The Company will allocatehas allocated the total $300.0 million initial transaction price to its one distinct performance obligation for the ARO-AAT license and the associated Takeda R&D Services.  Revenue will be recognized using a proportional performance method (based on actual costs incurredpatient visits completed versus total estimated costs incurredvisits completed for the Takeda R&D Services)ongoing SEQUOIA and AROAAT2002 clinical studies). Revenue for the three months ended December 31, 2021 and 2020 was $20.8 million and 2019$8.2 million, respectively. As of December 31, 2021, there were $8.2$0 in contract assets recorded as accounts receivable, $82.0 million in contract liabilities recorded as deferred revenue and $106.5 million in contract liabilities recorded as deferred revenue, net of the current portion, and $2.9 million in contract liabilities recorded as accrued expenses.  The $2.9 million in accrued expenses was primarily driven by co-development and co-commercialization activities.

Horizon Therapeutics Ireland DAC

On June 18, 2021, the Company entered into the Horizon License Agreement with Horizon.  Under the Horizon License Agreement, Horizon received a worldwide exclusive license for ARO-XDH, a previously undisclosed discovery-stage investigational RNAi therapeutic being developed by the Company as a potential treatment for people with uncontrolled gout. The Company will conduct all activities through the preclinical stages of development of ARO-XDH, and Horizon will be wholly responsible for clinical development and commercialization of ARO-XDH. In July 2021, the Company received $40 million as an upfront payment and is eligible to receive up to $660 million in potential development, regulatory and sales milestones.  The Company is also eligible to receive royalties in the low- to mid-teens range on net product sales.  

8


The Company has evaluated the Horizon License Agreement in accordance with FASB Topics 808 – Collaborative Arrangements and 606 - Revenue for Contracts from Customers. At the inception of the Horizon License Agreement, the Company identified one distinct performance obligation.  The Company determined that the key deliverables included the license and certain R&D services, including the Company’s responsibilities to conduct all activities through the preclinical stages of development of ARO-XDH (the “Horizon R&D Services”).  Due to the specialized and unique nature of these Horizon R&D Services and their direct relationship with the license, the Company determined that these deliverables represented 1 distinct bundle and, thus, 1 performance obligation.  Beyond the Horizon R&D Services, which are the responsibility of the Company, Horizon will be responsible for managing future clinical development and commercialization of ARO-XDH.  

The Company determined the initial transaction price totaled $40.0 million, including the upfront payment.  The Company has excluded any future estimated milestones or royalties, from this transaction price to date.  The Company will allocate the total $40.0 million initial transaction price to its 1 distinct performance obligation for the ARO-XDH license and the associated Horizon R&D Services. Revenue will be recognized on a straight-line basis over the estimated timeframe for completing the Horizon R&D Services.  The Company determined that the straight-line basis was appropriate as its efforts will be expended evenly over the course of completing its performance obligation. Revenue for the three months ended December 31, 2021 and 2020 was $6.7 million and $0, respectively.  As of December 31, 2020,2021, there were $8.2$0.1 million in contract assets recorded as accounts receivable.receivable, $26.7 million in contract liabilities recorded as deferred revenue.    

Glaxosmithkline Intellectual Property (No. 3) Limited

On November 22, 2021, the Company entered into an Exclusive License Agreement (the “GSK License Agreement”) with GSK.  Under the GSK License Agreement, GSK has received an exclusive license for ARO-HSD, the Company’s investigational RNAi therapeutic being developed as a treatment for patients with alcohol-related and nonalcohol related liver diseases, such as nonalcoholic steatohepatitis (NASH).  The exclusive license is worldwide with the exception of greater China, for which the Company will retain rights to develop and commercialize.  Beyond the Company’s Phase 1/2 study of (ARO-HSD), which the Company is responsible for completing, GSK is wholly responsible for clinical development and commercialization of ARO-HSD in its territory. Under the terms of the agreement, the Company has received an upfront payment of $120 million and is eligible for additional payments of $30 million at the start of Phase 2 and $100 million upon achieving a successful Phase 2 trial readout and the first patient dosed in a Phase 3 trial. Furthermore, should the Phase 3 trial read out positively, and the potential new medicine receives regulatory approval in major markets, the deal provides for commercial milestone payments to the Company of up to $190 million at first commercial sale, and up to $590 million in sales-related milestone payments. The Company is further eligible to receive tiered royalties on net product sales in a range of mid-teens to twenty percent.

The Company has evaluated the GSK License Agreement in accordance with FASB Topics 808 – Collaborative Arrangements and 606 - Revenue for Contracts from Customers. At the inception of the GSK License Agreement, the Company identified 1 distinct performance obligation.  The Company determined that the key deliverables included the license and certain R&D services, including the Company’s responsibility to complete the Phase 1/2 study, (the “GSK R&D Services”).  Due to the specialized and unique nature of these GSK R&D Services and their direct relationship with the license, the Company determined that these deliverables represented 1 distinct bundle and, thus, one performance obligation.  Beyond the GSK R&D Services, which are the responsibility of the Company, GSK will be responsible for managing future clinical development and commercialization in its territory.  

The Company determined the initial transaction price totaled $120.0 million, including the upfront payment. The Company has excluded any future estimated milestones or royalties from this transaction price to date.  The Company has allocated the total $120.0 million initial transaction price to its one distinct performance obligation for the ARO-HSD license and the associated GSK R&D Services.  Revenue will be recognized using a proportional performance method. As of December 31, 2021, 0 revenue or contract assets or liabilities were recognized as the GSK License Agreement had not yet completed customary closing conditions, including clearance by the relevant competition authorities.  This clearance was achieved in January 2022 and the upfront payment of $120.0 million was also received by the Company in January 2022.

 


NOTE 3. PROPERTY AND EQUIPMENT

The following table summarizes the Company’s major classes of property and equipment:

 

 

December 31, 2020

 

 

September 30, 2020

 

 

December 31, 2021

 

 

September 30, 2021

 

 

(In thousands)

 

 

(In thousands)

 

Computers, office equipment and furniture

 

$

662

 

 

$

662

 

Computers, software, office equipment and furniture

 

$

2,182

 

 

$

2,170

 

Research equipment

 

 

23,763

 

 

 

20,654

 

 

 

28,010

 

 

 

27,500

 

Software

 

 

356

 

 

 

631

 

Leasehold improvements

 

 

26,676

 

 

 

25,238

 

 

 

41,977

 

 

 

41,524

 

Construction in Progress

 

 

2,152

 

 

 

345

 

Land

 

 

2,996

 

 

 

-

 

Total gross fixed assets

 

 

51,457

 

 

 

47,185

 

 

 

77,317

 

 

 

71,539

 

Less: Accumulated depreciation and amortization

 

 

(17,727

)

 

 

(16,304

)

 

 

(25,014

)

 

 

(22,864

)

Property and equipment, net

 

$

33,730

 

 

$

30,881

 

 

$

52,303

 

 

$

48,675

 

 

Depreciation and amortization expense for property and equipment for the three months ended December 31, 2021 and 2020 was $2.1 million and 2019 was $1.4 million, respectively. Construction in Progress and $0.8 million, respectively.Land both relate to the Company’s Verona, Wisconsin research facility.

 

  

NOTE 4. INVESTMENTS

Investments at December 31, 20202021 primarily consisted of corporate bonds that have maturities of less than 36 months, a certificate of deposit and marketable equity securities. The Company’s corporate bonds consist of both short-term and long-term bonds and are classified as “held-to-maturity” on the Company’s Consolidated Balance Sheets. The Company’s certificate of deposit matures in less than 12 months and is classified as “held-to-maturity” on the Company’s Consolidated Balance Sheet.  The Company’s marketable equity securities consist of mutual funds that primarily invest in U.S. government bonds, U.S. government agency bonds, corporate bonds and other asset backedasset-backed debt securities. Dividends from these funds are automatically reinvested.re-invested.  The Company may also invest excess cash balances in certificates of deposits, money market accounts, government-sponsored enterprise securities, corporate bonds and/or commercial paper.  The Company accounts for its held to maturity investments in accordance with FASB ASC 320, Investments – Debt and Equity Securities and its marketable equity securities in accordance with ASC 321, Investments – Equity Securities.  

The following tables summarize the Company’s short-term and long-term investments and marketable securities as of December 31, 20202021 and September 30, 20202021 by measurement category.category:

 

Held to Maturity

 

As of December 31, 2020

 

 

 

 

As of December 31, 2021

 

 

 

 

(In thousands)

 

 

 

 

(In thousands)

 

 

 

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair Value

 

 

 

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair Value

 

 

 

Commercial notes (due within one year)

 

$

79,394

 

 

$

1,203

 

 

$

-

 

 

$

80,597

 

 

 

 

$

62,537

 

 

$

687

 

 

$

-

 

 

$

63,224

 

 

 

Commercial notes (due within one through three years)

 

$

110,855

 

 

$

3,634

 

 

$

(23

)

 

$

114,466

 

 

 

 

$

217,572

 

 

$

381

 

 

$

(1,374

)

 

$

216,579

 

 

 

Certificate of deposit (due within one year)

 

$

50,000

 

 

$

-

 

 

$

-

 

 

$

50,000

 

 

 

Total

 

$

190,249

 

 

$

4,837

 

 

$

(23

)

 

$

195,063

 

 

 

 

$

330,109

 

 

$

1,068

 

 

$

(1,374

)

 

$

329,803

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of September 30, 2020

 

 

 

 

As of September 30, 2021

 

 

 

 

(In thousands)

 

 

 

 

(In thousands)

 

 

 

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair Value

 

 

 

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair Value

 

 

 

Commercial notes (due within one year)

 

$

86,890

 

 

$

1,590

 

 

$

-

 

 

$

88,480

 

 

 

 

$

56,627

 

 

$

803

 

 

$

-

 

 

$

57,430

 

 

 

Commercial notes (due within one through three years)

 

$

137,487

 

 

$

4,573

 

 

$

(79

)

 

$

141,981

 

 

 

 

$

195,595

 

 

$

1,151

 

 

$

(103

)

 

$

196,643

 

 

 

Certificate of deposit (due within two years)

 

$

50,000

 

 

$

-

 

 

$

-

 

 

$

50,000

 

 

 

Total

 

$

224,377

 

 

$

6,163

 

 

$

(79

)

 

$

230,461

 

 

 

 

$

302,222

 

 

$

1,954

 

 

$

(103

)

 

$

304,073

 

 

 


 

Fair Value

 

As of December 31, 2020

 

 

 

 

 

 

As of December 31, 2021

 

 

(In thousands)

 

 

(In thousands)

 

 

Cost

 

 

Realized Gains/(Losses)

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair Value

 

 

Cost

 

 

Realized

Gains/(Losses)

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair Value

 

Marketable securities

 

$

85,095

 

 

$

477

 

 

$

440

 

 

$

-

 

 

$

86,012

 

 

$

125,000

 

 

$

3,134

 

 

$

-

 

 

$

(2,124

)

 

$

126,010

 

Total

 

$

85,095

 

 

$

477

 

 

$

440

 

 

$

-

 

 

$

86,012

 

 

$

125,000

 

 

$

3,134

 

 

$

-

 

 

$

(2,124

)

 

$

126,010

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of September 30, 2020

 

 

 

 

 

 

As of September 30, 2021

 

 

(In thousands)

 

 

(In thousands)

 

 

Cost

 

 

Realized Gains/(Losses)

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair Value

 

 

Cost

 

 

Realized

Gains/(Losses)

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair Value

 

Marketable securities

 

$

85,000

 

 

$

95

 

 

$

-

 

 

$

(75

)

 

$

85,020

 

 

$

125,000

 

 

$

2,481

 

 

$

135

 

 

$

(888

)

 

$

126,728

 

Total

 

$

85,000

 

 

$

95

 

 

$

-

 

 

$

(75

)

 

$

85,020

 

 

$

125,000

 

 

$

2,481

 

 

$

135

 

 

$

(888

)

 

$

126,728

 

 

Realized gains for marketable securities recorded at fair value consist of dividends received and re-invested into the associated fund.  

 

NOTE 5. INTANGIBLE ASSETS

Intangible assets subject to amortization include patents and a license agreement capitalized as part of the Novartis RNAi asset acquisition in March 2015. The license agreement associated with the Novartis RNAi asset acquisition is being amortized over the estimated life remaining at the time of acquisition, which was 21 years, and the accumulated amortization of the asset is $0.9$1.0 million.  The patents associated with the Novartis RNAi asset acquisition are being amortized over the estimated life remaining at the time of acquisition, which was 14 years, and the accumulated amortization of the assets is $9.1$10.6 million. Amortization expense for the three months ended December 31, 20202021 and 20192020 was $0.4 million and $0.4 million, respectively. Amortization expense is expected to be $1.3 million for the remainder of 2021, $1.7 million in fiscal2022, $1.7 million in 2023, $1.7 million in 2024, $1.7 million in 2025, $1.7 million in 2026 and $6.8$5.2 million thereafter.

The following table provides details on the Company’s intangible asset balances:

 

 

Intangible

assets

subject to

amortization

 

 

Intangible

Assets

Subject to

Amortization

 

 

(in thousands)

 

 

(in thousands)

 

Balance at September 30, 2020

 

$

15,363

 

Balance at September 30, 2021

 

$

13,663

 

Impairment

 

 

-

 

 

 

-

 

Amortization

 

 

(425

)

 

 

(425

)

Balance at December 31, 2020

 

$

14,938

 

Balance at December 31, 2021

 

$

13,238

 

 

NOTE 6. STOCKHOLDERS’ EQUITY

At December 31, 2020,2021, the Company had a total of 150,000,000 shares of capital stock authorized for issuance, consisting of 145,000,000 shares of Common Stock, par value $0.001 per share, and 5,000,000 shares of Preferred Stock, par value $0.001 per share.

At December 31, 2020,2021, 103,194,240104,798,186 shares of Common Stock were outstanding.  At December 31, 2020, 7,635,0232021, 14,834,548 shares of Common Stock were reserved for issuance upon exercise of options and vesting of restricted stock units granted or available for grant under Arrowhead’s 2004 Equity Incentive Plan, 2013 Incentive Plan, and 20132021 Incentive Plan, as well as for inducement grants made to new employees.employees under Rule 5635(c)(4) of the Nasdaq Listing Rules.

10In August 2020, the Company entered into an Open Market Sale Agreement (the “ATM Agreement”), pursuant to which the Company may, from time to time, sell up to $250,000,000 in shares of the Company’s Common Stock through Jefferies LLC, acting as the sales agent and/or principal, in an at-the-market offering. The Company is not required to sell shares under the ATM Agreement. The Company will pay Jefferies LLC a commission of up to 3.0% of the aggregate gross proceeds received from all sales of the common stock under the ATM Agreement. Unless otherwise terminated, the ATM Agreement continues until the earlier of selling all shares available under the ATM Agreement or December 2, 2022. At December 31, 2021, 0 shares have been sold under the ATM Agreement.

11


NOTE 7. COMMITMENTS AND CONTINGENCIES

Litigation

From time to time, the Company may be subject to various claims and legal proceedings in the ordinary course of business.  If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount is reasonably estimable, the Company will accrue a liability for the estimated loss. There were 0 contingent liabilities recorded as of the three months ended December 31, 2020.2021.

Purchase Commitments

In the normal course of business,On December 20, 2021, the Company enters into variouscompleted a purchase commitments forof 13 acres of land in the manufacture of drug components, for toxicology studies and for clinical studies.  As of December 31, 2020, these future commitments were estimated at approximately $100.2 million, ofVerona Technology Park in Verona, WI, which approximately $85.0 million is expectedplanned to be incurred in remaining fiscal year 2021.the site of an approximately 140,000 square foot drug manufacturing facility and an approximately 115,000 square foot laboratory and office facility to support process development and analytical activities. Arrowhead intends to invest between $200 million and $250 million into the buildout of the facilities. As part of this acquisition, the Company also entered into a development agreement with the City of Verona to construct certain infrastructure improvements within the TIF district, and will be reimbursed by the City of Verona by future tax increment revenue generated from the developed property. The total amount of funding that City of Verona will pay as reimbursements under the TIF program for these improvements is not guaranteed and will depend on future tax revenues generated from the developed property.

Technology License Commitments

The Company has licensed from third parties the rights to use certain technologies for its research and development activities, as well as in any products the Company may develop using these licensed technologies. These agreements and other similar agreements often require milestone and royalty payments.  Milestone payments, for example, may be required as the research and development process progresses through various stages of development, such as when clinical candidates enter or progress through clinical trials, upon a new drug application and upon certain sales level milestones.  These milestone payments could amount to the mid to upper double-digit millions of dollars. During the three months ended December 31, 20202021 and 2019,2020, the Company did 0t reach any milestones. InUnder certain agreements, the Company may be required to make mid to high single-digit percentage royalty payments based on a percentage of the sales of the relevant products.    

 

 

NOTE 8. LEASES

Leases

In April 2019, the Company entered into a lease for its corporate headquarters in Pasadena, California.  The 91 month office building lease between the Company and 177 Colorado Owner, LLC is for approximately 24,000 square feet of office space located at 177 E. Colorado Blvd, Pasadena, California.  The increased capacity of this new office space compared to the Company’s prior corporate headquarters will accommodate increased personnel as the Company’s pipeline of drug candidates expands and moves closer to market. Lease payments began on September 30, 2019 and are estimated to total approximately $8.7 million over the term.  The lease expires on April 30, 2027.  The Company has paid approximately $3.5 million for leasehold improvements, net of tenant improvement allowances.  The lease contains an option to renew for 1 term of five years. The exercise of this option was not determined to be reasonably certain and thus was not included in lease liabilities on the Company’s Consolidated Balance Sheet at December 31 2020., 2021. On October 23, 2020, the Company signedentered into a lease expansion to add an additional approximately 24,000 square feet of office space at the same location for its corporate headquarters. The lease commencement date is expected to beLease payments for the expansion began in July 2021 after certain leasehold improvements are completed, and the lease for the expansion expires in April 2027. The lease payments for the expansion are expected to total $6.9 million.  The Company anticipates payinghas paid approximately $4.0 million of leasehold improvements, net of tenant improvement allowances.allowances, for the lease expansion.  The increased capacity of this additional office space compared to the Company’s current corporate headquarters willis intended to accommodate increased personnel as the Company’s pipeline of drug candidates expandscontinues to expand and movesmove closer to market. 

12


In January 2016, the Company entered into a lease for its research facility in Madison, Wisconsin.  The lease was for approximately 60,000 square feet of office and laboratory space and had an expiration date of September 30, 2026. The lease was amended in January 2019 and May 2020 to expand the rentable square feet by an additional 40,000 total square feet and extendedto extend the lease expiration date to September 30, 2031. Lease payments are estimated to total approximately $26.2 million for the term. The Company anticipates payingincurred approximately $11.0 million of leasehold improvements for the additional 40,000 square feet, net of tenant improvement allowances. The lease contains 2 options to renew for two terms of five years. The exercise of these options were not determined to be reasonably certain and thus was not included in lease liabilities on the Company’s Consolidated Balance Sheet at December 31 2020., 2021.  In November 2020 and December 2020, twothe Company entered into amendments were signed to expand the rentable square space by an additional 10,743 square feet and these amendments added a total of approximately $1.2 million of lease payments for the remainder of the term.    

 

In March 2020, the Company entered into a sublease agreement (the “Sublease”) with Halozyme, Inc. for additional research and development facility space in San Diego, California.  The Sublease provides additional space needed to accommodate the recent growth of the Company’s personnel and discovery efforts. The subleaseSublease is for approximately 21,000 rentable square feet.  The term of the Sublease commenced on April 1, 2020 and will end on January 14, 2023.  Sublease payments are estimated to total approximately $2.0 million over the term.

11


On November 19, 2021, the Company entered into a new lease for a San Diego, California research facility.  The 15-year lease is for approximately 144,000 square feet of office and research and development laboratory space to be constructed in San Diego, California.  This lease will replace the Company’s current research facility sublease for property located in San Diego, California.  The increased capacity of this new facility compared to the Company’s current research facility in San Diego will accommodate increased personnel for the Company’s expanding pipeline of current and future drug candidates. The estimated rent commencement date for the lease is in May 2023, after construction and leasehold improvements have been completed.  The lease payments, which begin on the rent commencement date, will be approximately $119.0 million over the initial 15-year term.  The Company also estimates payments for operating expenses to be approximately $3.0 million for the first year of the lease, and these payments will continue throughout the initial 15-year term. The Company expects to pay approximately $31.0 million for leasehold improvements, net of tenant improvement allowances.  Pursuant to the lease, within twelve months of the expiration of the initial 15-year term, the Company has the option to extend the lease for up to 1 additional ten-year term, with certain annual increases in base rent. No lease liabilities have been recorded as of December 31, 2021 as the lease commencement date has not yet occurred.

Operating lease cost during the three months ended December 31, 2021 and 2020 and 2019 was $0.9$1.3 million and $0.5$0.9 million, respectively. Variable lease costs for the three months ended December 31, 20202021 and 20192020 was $0.2 million and $0.2 million, respectively. There was 0 short-term lease cost during the three months ended December 31, 20202021 and 2019.2020.

The following table presents maturities of operating lease liabilities on an undiscounted basis as of December 31, 2020:2021:

 

 

(in thousands)

 

 

(in thousands)

 

2021 (remainder of fiscal year)

 

$

2,379

 

2022

 

 

3,853

 

 

$

3,685

 

2023

 

 

3,406

 

 

 

4,786

 

2024

 

 

3,269

 

 

 

4,621

 

2025

 

 

3,358

 

 

 

4,749

 

2026 and thereafter

 

 

15,331

 

2026

 

 

5,050

 

2027 and thereafter

 

 

13,200

 

Total

 

$

31,596

 

 

$

36,091

 

Less imputed interest

 

$

(10,728

)

 

$

(10,776

)

Total operating lease liabilities (includes current portion)

 

$

20,868

 

 

$

25,315

 

 

Cash paid for the amounts included in the measurement of the operating lease liabilities on the Company’s Consolidated Balance Sheet and included in Other changes in operating assets and liabilities within cash flows from operating activities on the Company’s Consolidated StatementStatements of Cash FlowFlows for the three months ended December 31, 2021 and 2020 and 2019 was $0.7$1.0 million and $0.3$0.7 million, respectively. The weighted-average remaining lease term and weighted-average discount rate for all leases as of December 31 2020, 2021 was 9.27.8 years and 8.4%8.5%, respectively.


NOTE 9. STOCK-BASED COMPENSATION

Arrowhead has twothree plans that provide for equity-based compensation. Under the 2004 Equity Incentive Plan and the 2013 Incentive Plan, as of December 31, 2020, 509,2102021, 376,301 and 5,102,3604,904,814 shares, respectively, of Arrowhead’s Common Stock are reserved for the grant of stock options, stock appreciation rights, and restricted stock awards and performance unit/shareunit awards to employees, consultants and others. No further grants may be made under the 2004 Equity Incentive Plan.  As of December 31, 2020,2021, there were options granted and outstanding to purchase 509,210376,301 and 2,320,6401,948,814 shares of Common Stock under the 2004 Equity Incentive Plan and the 2013 Incentive Plan, respectively, and there were 2,385,2002,956,000 restricted stock units granted and outstanding under the 2013 Incentive Plan. Also, as of December 31, 2020,2021, there were 1,260,503889,890 shares reserved for options and 762,950651,000 shares reserved for restricted stock units issued as inducement grants to new employees outside of equity compensation plans. Under the 2021 Incentive Plan, as of December 31, 2021, 3,000 shares of Common Stock and 76,400 restricted stock units were granted and outstanding under the 2021 Incentive Plan.  As of December 31, 2021, the total number of authorized shares under the 2021 Incentive Plan was 8,012,543 shares, which includes 91,943 shares that were forfeited under the 2013 Incentive Plan.

Stock Options

The following table summarizes information about stock options:

 

 

Number of

Options

Outstanding

 

 

Weighted-

Average

Exercise

Price

Per Share

 

 

Weighted-

Average

Remaining

Contractual

Term

 

Aggregate

Intrinsic

Value

 

 

Number of

Options

Outstanding

 

 

Weighted-

Average

Exercise

Price

Per Share

 

 

Weighted-

Average

Remaining

Contractual

Term

 

Aggregate

Intrinsic

Value

 

Balance at September 30, 2020

 

 

4,539,403

 

 

$

16.67

 

 

 

 

 

 

 

Balance at September 30, 2021

 

 

3,456,239

 

 

$

19.60

 

 

 

 

 

 

 

Granted

 

 

144,000

 

 

63.64

 

 

 

 

 

 

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

Cancelled

 

 

(55,438

)

 

24.48

 

 

 

 

 

 

 

 

 

(30,420

)

 

35.57

 

 

 

 

 

 

 

Exercised

 

 

(537,612

)

 

9.49

 

 

 

 

 

 

 

 

 

(207,814

)

 

10.32

 

 

 

 

 

 

 

Balance at December 31, 2020

 

 

4,090,353

 

 

$

19.16

 

 

6.3 years

 

$

235,465,861

 

Exercisable at December 31, 2020

 

 

2,556,040

 

 

$

9.56

 

 

4.8 years

 

$

171,695,135

 

Balance at December 31, 2021

 

 

3,218,005

 

 

$

20.05

 

 

5.4 years

 

$

149,311,699

 

Exercisable at December 31, 2021

 

 

2,460,188

 

 

$

13.69

 

 

4.6 years

 

$

129,520,403

 

 

 

Stock-based compensation expense related to stock options for the three months ended December 31, 2021 and 2020 and 2019 was $3.1$3.0 million and $1.6$3.1 million, respectively. For non-qualified stock options, the expense creates a timing difference, resulting in a deferred tax asset, which is fully reserved by a valuation allowance.

The grant date fair value of the options granted by the Company for the three months ended December 31, 2021 and 2020 was $0 and 2019 was $6.8 million and $8.6 million, respectively.  

The intrinsic value of the options exercised during the three months ended December 31, 2021 and 2020 was $12.5 million and 2019 was $32.0 million, and $21.6 million, respectively.

12


As of December 31, 2020,2021, the pre-tax compensation expense for all outstanding unvested stock options in the amount of $39.0$22.4 million will be recognized in the Company’s results of operations over a weighted average period of 3.12.2 years.

The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options, which do not have vesting restrictions and are fully transferable. The determination of the fair value of each stock option is affected by the Company’s stock price on the date of grant, as well as assumptions regarding a number of highly complex and subjective variables. Because the Company’s employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options.

14


The assumptions used to value stock options are as follows:

 

 

Three Months Ended December 31,

 

 

 

Three Months Ended December 31,

 

 

 

2020

 

 

2019

 

 

 

2021

 

2020

 

 

Dividend yield

 

 

-

 

 

 

-

 

 

 

N/A

 

 

-

 

 

Risk-free interest rate

 

0.4 – 0.6%

 

 

1.4 - 1.8%

 

 

 

N/A

 

0.4 – 0.6%

 

 

Volatility

 

90.0-90.4%

 

 

90.5-91.0%

 

 

 

N/A

 

90.0 – 90.4%

 

 

Expected life (in years)

 

 

6.25

 

 

 

6.25

 

 

 

N/A

 

 

6.25

 

 

Weighted average grant date fair value per share of options granted

 

$

47.34

 

 

$

39.05

 

 

 

N/A

 

$

47.34

 

 

 

 

The dividend yield is 0 as the Company currently does not pay a dividend.

The risk-free interest rate is based on that of the U.S. Treasury bond.

Volatility is estimated based on volatility average of the Company’s Common Stock price.

Restricted Stock Units

Restricted stock units (“RSUs”), including time-based, market condition-based, and performance-basedperformance condition-based awards, werehave been granted under the Company’s 2013 Incentive Plan, 2021 Incentive Plan, and as inducements grants granted outside of the Plan. DuringCompany’s equity-based compensation plans under Rule 5635(c)(4) of the three months ended December 31, 2020, the Company issued 2,200 RSUs under the 2013 Incentive Plan and 116,000 RSUs as inducement awards.Nasdaq Listing Rules.  At vesting, each outstanding RSU will be exchanged for one share of the Company’s Common Stock. RSU recipients may elect to net share settle upon vesting, in which case the Company pays the employee’s income taxes due upon vesting and withholds a number of shares of Common Stock of equal value. RSU awards generally vest subject to the satisfaction of service requirements or the satisfaction of both service requirements and achievement of certain performance targets.  

The following table summarizes the activity of the Company’s RSUs:

 

 

Number of

RSUs

 

 

Weighted-

Average

Grant

Date

Fair Value

 

 

Number of

RSUs

 

 

Weighted-

Average

Grant

Date

Fair Value

 

Unvested at September 30, 2020

 

 

3,524,025

 

 

$

44.11

 

Unvested at September 30, 2021

 

 

3,731,850

 

 

$

60.82

 

Granted

 

 

118,200

 

 

 

62.26

 

 

 

122,500

 

 

 

62.60

 

Vested

 

 

(280,325

)

 

 

22.92

 

 

 

(263,700

)

 

 

61.11

 

Forfeited

 

 

(213,750

)

 

 

41.34

 

 

 

(7,250

)

 

 

83.54

 

Unvested at December 31, 2020

 

 

3,148,150

 

 

$

46.87

 

Unvested at December 31, 2021

 

 

3,583,400

 

 

$

60.82

 

 

 

During the three months ended December 31, 20202021 and 2019,2020, the Company recorded $5.0$21.5 million and $2.9$5.0 million of expense related to RSUs, respectively. Such expense is included in stock-based compensation expense in the Company’s Consolidated StatementStatements of Operations and Comprehensive Income (Loss). For RSUs, the expense creates a timing difference, resulting in a deferred tax asset, which is fully reserved by a valuation allowance.  

For RSUs, the grant date fair value of the award is based on the Company’s closing stock price at the grant date, with consideration given to the probability of achieving performance conditions for performance-based awards. The grant date fair value of the RSUs granted by the Company for the three months ended December 31, 2021 and 2020 was $7.7 million and $7.4 million, respectively.

13


As of December 31, 2020,2021, the pre-tax compensation expense for all unvested RSUs in the amount of $82.0$139.7 million will be recognized in the Company’s results of operations over a weighted average period of 3.0 years.  Unvested RSUs that we have deemed not probable of vesting as of2.6 years.  

During the three months ended December 31, 2020, have the potential of generating2021, certain performance condition-based awards were modified to either add an additional $38.1market condition component, or to replace performance conditions with market conditions entirely.  The Company assessed the modification date fair value based on a monte carlo simulation model.   millionThe fair value of pre-tax compensation expense if we deem them probable of vesting in a future reporting period.  market condition-based awards  is expensed ratably over the service period and is not adjusted for actual achievement.

15


 

 

NOTE 10. FAIR VALUE MEASUREMENTS

The Company measures its financial assets and liabilities at fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., exit price) in an orderly transaction between market participants at the measurement date. Additionally, the Company is required to provide disclosure and categorize assets and liabilities measured at fair value into one of three different levels depending on the assumptions (i.e., inputs) used in the valuation. Level 1 provides the most reliable measure of fair value while Level 3 generally requires significant management judgment. Financial assets and liabilities are classified in their entirety based on the lowest level of input significant to the fair value measurement. The fair value hierarchy is defined as follows:

Level 1—Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities.

Level 2—Valuations are based on quoted prices for similar assets or liabilities in active markets, or quoted prices in markets that are not active for which significant inputs are observable, either directly or indirectly.

Level 3—Valuations are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. Inputs reflect management’s best estimate of what market participants would use in valuing the asset or liability at the measurement date.

The following table summarizes fair value measurements at December 31, 20202021 and September 30, 20202021 for assets and liabilities measured at fair value on a recurring basis.basis:  

December 31, 2020:2021:

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

(in thousands)

 

 

(in thousands)

 

Cash and cash equivalents

 

$

139,921

 

 

$

-

 

 

$

-

 

 

$

139,921

 

 

$

91,587

 

 

$

-

 

 

$

-

 

 

$

91,587

 

Marketable securities

 

$

86,012

 

 

$

-

 

 

$

-

 

 

$

86,012

 

 

$

126,010

 

 

$

-

 

 

$

-

 

 

$

126,010

 

Short-term investments (held to maturity)

 

$

-

 

 

$

80,597

 

 

$

-

 

 

$

80,597

 

 

$

-

 

 

$

113,224

 

 

$

-

 

 

$

113,224

 

Long-term investments (held to maturity)

 

$

-

 

 

$

114,466

 

 

$

-

 

 

$

114,466

 

 

$

-

 

 

$

216,579

 

 

$

-

 

 

$

216,579

 

Contingent consideration

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

 

September 30, 20202021:

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

(in thousands)

 

 

(in thousands)

 

Cash and cash equivalents

 

$

143,583

 

 

$

-

 

 

$

-

 

 

$

143,583

 

 

$

184,434

 

 

$

-

 

 

$

-

 

 

$

184,434

 

Marketable securities

 

$

85,020

 

 

 

 

 

 

 

 

 

 

$

85,020

 

 

$

126,728

 

 

$

-

 

 

$

-

 

 

$

126,728

 

Short-term investments (held to maturity)

 

$

-

 

 

$

88,480

 

 

$

-

 

 

$

88,480

 

 

$

-

 

 

$

57,430

 

 

$

-

 

 

$

57,430

 

Long-term investments (held to maturity)

 

$

-

 

 

$

141,981

 

 

$

-

 

 

$

141,981

 

 

$

-

 

 

$

246,643

 

 

$

-

 

 

$

246,643

 

Contingent consideration

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

$

-

 

 

    


ITEM  2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and we intend that such forward-looking statements be subject to the safe harbors created thereby. For this purpose, any statements contained in this Quarterly Report on Form 10-Q except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “plan,” “project,” “could,” “estimate,” “target,” “forecast,” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our businesses,business, or other characterizations of future events or circumstances are forward-looking statements.

The forward-looking statements included herein are based on current expectations of our management based on available information and involve a number of risks and uncertainties, all of which are difficult or impossible to predict accurately, and many of which are beyond our control. In addition, many of these risks and uncertainties may be exacerbated by the COVID-19 pandemic and any worsening of the global business and economic environment as a result. As such, our actual results may differ materially from those expressed in any forward-looking statements. Readers should carefully review the factors identified in our most recent Annual Report on Form 10-K under the caption “Risk Factors” as well as the additional risks and uncertainties described in other documents we file from time to time with the Securities and Exchange Commission (“SEC”), including this Quarterly Report on Form 10-Q and subsequent quarterly reports on Form 10-Q.for the quarter ended December 31, 2021. In light of the significant risks and uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by us or any other person that such results will be achieved, and readers are cautioned not to place undue reliance on such forward-looking information. Except as may be required by law, we disclaim any intent to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Description of Business

Unless otherwise noted, (1) the term “Arrowhead” refers to Arrowhead Pharmaceuticals, Inc., a Delaware corporation and its Subsidiaries, (2) the terms “Company,” “we,” “us,” and “our,” refer to the ongoing business operations of Arrowhead and its Subsidiaries, whether conducted through Arrowhead or a subsidiary of Arrowhead, (3) the term “Subsidiaries” refers to Arrowhead Madison Inc. (“Arrowhead Madison”) and Arrowhead Australia Pty Ltd (“Arrowhead Australia”), (4) the term “Common Stock” refers to Arrowhead’s Common Stock, par value $0.001 per share, (5) the term “Preferred Stock” refers to Arrowhead’s Preferred Stock, par value $0.001 per share, and (6) the term “Stockholder(s)” refers to the holders of Arrowhead Common Stock.

Overview

Arrowhead Pharmaceuticals, Inc. develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep and durable knockdown of target genes. RNA interference (“RNAi”) is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. The Company'sCompany’s pipeline includes ARO-APOC3 for hypertriglyceridemia, ARO-ANG3 for dyslipidemia, ARO-HSD for liver disease, ARO-ENaC for cystic fibrosis, ARO-HIF2 for renal cell carcinoma, ARO-LUNG2 as a candidate to treatARO-DUX4 for facioscapulohumeral muscular dystrophy, ARO-LUNG2 for chronic obstructive pulmonary disorder, (“COPD”) and ARO-COV for treatment for the current novel coronavirus that causes COVID-19 and other possible future pulmonary-borne pathogens.pathogens, ARO-C3 for complement mediated diseases and ARO-RAGE and ARO-MUC5AC for various muco-obstructive or inflammatory pulmonary conditions. ARO-ARO-JNJ1,HSD for liver disease was out-licensed to Glaxosmithkline Intellectual Property (No. 3) Limited (“GSK”) in November 2021.  ARO-XDH is being developed for uncontrolled gout under a collaboration agreement with Horizon Therapeutics Ireland DAC (“Horizon”).  ARO-JNJ2 and ARO-JNJ3 are being developed for undisclosed liver-expressed targets under a collaboration agreement with Janssen Pharmaceuticals, Inc. (“Janssen”).  JNJ-75220795 (ARO-JNJ1) is being developed by Janssen as a potential treatment for patients with non-alcoholic steatohepatitis (NASH). ARO-AAT for liver disease associated with alpha-1 antitrypsin deficiency (“AATD”) was out-licensed to Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) in October 2020. JNJ3989JNJ-3989 (formerly referred to as ARO-HBV) for chronic hepatitis B virus was out-licensed to Janssen in October 2018.  Olpasiran (formerly referred to as AMG 890 or ARO-LPA) for cardiovascular disease was out-licensed to Amgen Inc. (“Amgen”) in 2016.

Arrowhead operates lab facilities in Madison, Wisconsin and San Diego, California, where the Company’s research and development activities, including the development of RNAi therapeutics, are based.take place. The Company’s principal executive offices are located in Pasadena, California.

Arrowhead has focused its resources on therapeutics that exclusively utilize the Company’s Targeted RNAi Molecule (TRiMTM) platform technology. Therapeutics built on the TRiMTM platform have demonstrated high levels of pharmacologic activity in multiple animal models spanning several therapeutic areas. TRiMTM enabled therapeutics offer several potential advantages over prior generation and competing technologies, including: simplified manufacturing and reduced costs; multiple routes of administration including subcutaneous injection and inhaled administration; the ability to target multiple tissue types including liver, lung and tumors; and the potential for improved safety and reduced risk of intracellular buildup, because there are less metabolites from smaller, simpler molecules.  

1517


During the first quarter of fiscal year 2021,2022, the Company continued to develop and advance its pipeline and partnered candidates.  The Company hosted a key opinion leader webinar oncandidates and expanded its cardiometabolic candidates, ARO-APOC3 and ARO-ANG3. The Company presented positive interim clinical data from AROAAT2002, an open-label Phase 2 clinical study of ARO-AAT,facilities to support the Company’s second-generation investigational RNAi therapeutic being developed as a treatment for the rare genetic liver disease associated with AATD.  The Company also announced positive clinical data on its cardiometabolic candidates, ARO-APOC3 and ARO-ANG3, at the American Heart Association (“AHA”) Scientific Session 2020.  Finally, the Company announced a collaboration with Takeda to co-develop and co-commercialize ARO-AAT for alpha-1 antitrypsin-associated liver disease.  See Note 2 of the Notes to Consolidated Financial Statements included elsewhere in this Quarterly Report on Form 10-Q for more information regarding the collaboration with Takeda.growing pipeline.  Several key recent developments include:

The Company’s partnered candidates under its collaboration agreements also continue to progress.  Janssen began dosing patients in a Phase 2b triple combination study called REEF-1, designed to enroll up to 450 patients with chronic hepatitis B infection. In connection with the start of this study, Arrowhead earned a $25.0 million milestone payment under the Company’s License Agreement with Janssen (“Janssen License Agreement”).  The Company is currently performing discovery, optimization and preclinical research and development for ARO-JNJ1, ARO-JNJ2 and ARO-JNJ3 for Janssen as part of the Company’s Research Collaboration and Option Agreement with Janssen (“Janssen Collaboration Agreement”).  Under the terms of the Janssen agreements taken together, the Company has received $175.0 million as an upfront payment, $75.0 million in the form of an equity investment by Johnson & Johnson Innovation-JJDC, Inc. (“JJDC”) in Arrowhead Common Stock, two $25.0 million milestone payments and may receive up to $1.6 billion in development and sales milestones payments for the Janssen License Agreement, and up to $1.9 billion in development and sales milestone payments for the three additional targets covered under the Janssen Collaboration Agreement.  The Company is further eligible to receive tiered royalties on product sales up to mid-teens under the Janssen License Agreement and up to low teens under the Janssen Collaboration Agreement.  

The Company’s collaboration agreement with Amgen for Olpasiran (previously referred to as AMG 890 or ARO-LPA), (the “Second Collaboration and License Agreement” or “Olpasiran Agreement”) continues to progress.  In July 2020, Amgen initiated a Phase 2 clinical study, which resulted in a $20.0 million milestone payment to the Company.  The Company has received $35.0 million in upfront payments, $21.5 million in the form of an equity investment by Amgen in the Company’s Common Stock, $30.0 million in milestone payments, and may receive up to an additional $400.0 million in remaining development, regulatory and sales milestone payments.  The Company is eligible to receive up to low double-digit royalties for sales of products under the Olpasiran Agreement.

On October 7, 2020, the Company entered into an Exclusive License and Co-Funding Agreement with Takeda (the “Takeda License Agreement”).  Under the Takeda License Agreement, Takeda and the Company will co-develop the Company’s ARO-AAT program. Within the United States, ARO-AAT, if approved, will be co-commercialized under a 50/50 profit sharing structure.  Outside the United States, Takeda will lead the global commercialization strategy and receive an exclusive license to commercialize ARO-AAT with the Company eligible to receive tiered royalties of 20% to 25% on net sales.  In January 2021, the Company received $300.0 million as an upfront payment and is eligible to receive potential development, regulatory and commercial milestones of up to $740.0 million.  

The revenue recognition for these collaboration agreements is discussed further in Note 2 of the Notes to Consolidated Financial Statements of Part I, Item 1. Financial Statements of this Quarterly Report on Form 10-Q.

The Company continues to develop other clinical candidates for future clinical trials. Clinical candidates are tested internally and through GLP toxicology studies at outside laboratories.  Drug materials for such studies and clinical trials are either contracted to third-party manufactures or manufactured internally.  The Company engages third-party contract research organizations (“CROs”) to manage clinical trials and works cooperatively with such organizations on all aspects of clinical trial management, including plan design, patient recruiting, and follow up.  These outside costs, relating to the preparation for and administration of clinical trials, are referred to as “candidate costs.”  If the clinical candidates progress through human testing, candidate costs will increase. 

i)

dosed the first patients in its PALISADE study, a phase 3 clinical study to evaluate the safety and efficacy of ARO-APOC3 in adults with familial chylomicronemia syndrome (FCS);

ii)

entered into an exclusive license agreement with GSK for ARO-HSD;

iii)

Janssen presented clinical data from REEF-1, a Phase 2b study of different combination regimens, including JNJ-73763989 (JNJ-3989), formerly called ARO-HBV, and/or JNJ-56136379 (JNJ-6379), and a nucleos(t)ide analog (NA) for the treatment of chronic hepatitis B virus infection (CHB);

iv)

filed for regulatory clearance to begin a Phase 1/2a study of ARO-C3;

v)

presented additional interim clinical data from AROHSD1001, AROAAT2002, and AROAPOC31001; and

vi)

completed the purchase of 13 acres of land in the Verona Technology Park in Verona, Wisconsin, which is planned to be the site of an approximately 140,000 square foot laboratory and office facility and entered into a lease agreement for a new 144,000 square foot laboratory and office facility in San Diego, California.  Both facilities will provide additional space to support the Company’s continued growth.

The Company is actively monitoring the ongoing COVID-19 pandemic. The financial results for the three months ended December 31, 20202021 were not significantly impacted by COVID-19. During fiscal year 2020,Operationally, the Company had temporarily pausedhas experienced delays in its earlier stage programs due to a shortage in non-human primates, which are critical to the Company’s preclinical programs. Additionally, the Company has experienced delays in enrollment in its two ARO-AAT studies, SEQUOIA and the ARO-AAT 2002 study, but resumed the process of screening and enrolling patients. During the pause in enrollment, patients already enrolled in these studies continued to be dosed per protocol and continued to come in for their follow up visits. Additional delays have occurred in the Company’s earlier stage programs, but the Company does not expect a material impact to any program’s anticipated timelines. Additionally, theclinical trials. The Company’s operations at its research and development facilities in Madison, Wisconsin and San Diego, California, and its corporate headquarters in Pasadena, California have continued to operate with limited impact, other than for enhanced safety measures, including work from home policies.policies and intermittent lab supply shortages. However, the Company cannot predict the impact the progression of COVID-19 will have on future financial and operational results due to a variety of factors, including the ability of the Company’s clinical sites to continue to enroll subjects, the ability of the Company’s suppliers to continue to operate, the continued good health and safety of the Company’s employees and ultimately the length and severity of the COVID-19 pandemic.

16


Net losses were $62.9 million for the three months ended December 31, 2021 as compared to net losses of $20.7 million for the three months ended December 31, 2020 as compared to net2020.  Net losses of $2.7 millionper share-diluted were $0.60 for the three months ended December 30, 2019. Net31, 2021 as compared to net losses per share-diluted wereof $0.20 for the three months ended December 31, 2020 as compared to2020. The increase in net losses per share-diluted of $0.03 for the three months ended December 31, 2019. An2021 was due to an increase in research and development and general and administrative expenses coupled with a decreaseas Company’s pipeline of candidates has expanded and progressed through clinical trial phases, partially offset by an increase in revenue from the Company’s license and collaboration agreements, with Janssen wereprimarily from the drivers of the increase in net lossesTakeda License Agreement (as defined below) and net losses per share for the three months ended December 31, 2020, as discussed further below.Horizon License Agreement (as defined below).  

The Company has strengthened its liquidity and financial position through upfront and milestone payments received under its collaboration agreements, as well as equity financings. Under the terms of the Company’s agreements with Janssen, taken together, the Company has received $175.0 million as an upfront payment, $75.0 million in the form of an equity investment by JJDC in Arrowhead Common Stock, and two $25.0 millionfour milestone payments.payments totaling $70.0 million. Under the terms of the Company’s agreements with Amgen, the Company has received $35.0 million in upfront payments, $21.5 million in the form of an equity investment by Amgen in the Company’s Common Stock and $30.0 million in milestone payments. The Company’s October 2020 licensing agreement withThe Takeda will resultLicense Agreement resulted in a $300.0 million upfront payment, and the Horizon License Agreement resulted in a $40.0 million upfront payment. Finally, the GSK License Agreement (as defined below) resulted in an upfront payment of $120.0 million, which has been collectedwas received in the beginning of the second quarter of 2021. Additionally, in December 2019, the Company completed a securities offering which generated approximately $250.5 million in net cash proceeds. These cash proceeds secure the funding needed to continue to advance our pipeline candidates.January 2022. The Company had $139.9$91.6 million of cash and cash equivalents, $86.0$126.0 million of marketable securities, $79.4$112.5 million in short-term investments, $110.9$217.6 million of long term investments and $499.3$638.5 million of total assets as of December 31, 2020,2021, as compared to $143.6$184.4 million $85.0of cash and cash equivalents, $126.7 million $86.9of marketable securities, $56.6 million $137.5in short-term investments, $245.6 million of long term investments and $522.5$710.1 million of total assets as of September 30, 2020, respectively.2021. Based upon the Company’s current cash and investment resources and operating plan, the Company expects to have sufficient liquidity to fund operations for at least the next twelve months.

Critical Accounting Policies and Estimates

There have been no changes to the significant accounting policies disclosed in the Company’s most recent Annual Report on Form 10-K.

18


Results of Operations

The following data summarizes our results of operations for the following periods indicated:

 

 

 

Three Months Ended December 31,

 

 

 

2020

 

 

2019

 

 

 

(in thousands, except per share amounts)

 

Revenues

 

$

21,303

 

 

$

29,455

 

Operating Income (loss)

 

$

(24,054

)

 

$

(4,853

)

Net Income (loss)

 

$

(20,732

)

 

$

(2,673

)

Net Income (Loss) per Share-

   Diluted

 

$

(0.20

)

 

$

(0.03

)

 

 

Three Months Ended December 31,

 

 

 

2021

 

 

2020

 

 

 

(in thousands, except per share

amounts)

 

Revenues

 

$

27,439

 

 

$

21,303

 

Operating income (loss)

 

$

(63,321

)

 

$

(24,054

)

Net income (loss)

 

$

(62,872

)

 

$

(20,732

)

Net income (Loss) per share-diluted

 

$

(0.60

)

 

$

(0.20

)

 

The decreaseincrease in revenue for the three months ended December 31, 20202021 compared to the three months ended December 31, 20192020 was driven by the timing of the recognition of the $252.6 million initial transaction price associated with our agreements with Janssen and JJDC as we achieved progress toward completing our performance obligation under those agreements; partially offset by the revenue recognized forfrom the Takeda collaboration.License Agreement and the Horizon License Agreement. The increase in Net Lossesnet losses during the three months ended December 31, 20202021 compared to the three months ended December 31, 20192020 was driven by this decreasean increase in Revenueresearch and also increases in Researchdevelopment and Development Expensesgeneral and administrative expenses as our pipeline of clinical candidates has continued to increase.increase and progress through clinical trial phases, partially offset by an increase in revenue from the Takeda License Agreement and the Horizon License Agreement.

Revenue

Total revenue for the three months ended December 31, 2021 and 2020 was $27.4 million and 2019 was $21.3 million, and $29.5 million, respectively.  Revenue in the current period is primarily related to the recognition of a portion of the $252.6 million initial transaction price associated with our agreements with Janssen and JJDC as we achieved progress towards completing our performance obligation under those agreements.  In addition, revenue in the current period consisted of $8.2 million of revenue associated with the Takeda collaboration.  Revenue for the three months ended December 31, 2019, was2021 is primarily related to the recognition of a portion$20.8 million of the $252.6 million initial transaction pricerevenue associated with our agreementsthe Takeda License Agreement and the recognition of $6.7 million of revenue associated with Janssen and JJDC.  A higher proportion of performance activity was ongoing during the prior period than the current period, which resulted in the higher revenue recognized in the prior period.Horizon License Agreement.

17


Amgen Inc.

On September 28, 2016, the Company entered into two Collaboration and License Agreements and a Common Stock Purchase Agreement with Amgen. Under one of the collaboration and license agreements (the “Secondand a common stock purchase agreement with Amgen. Under the Second Collaboration and License Agreement” orAgreement (the “Olpasiran Agreement”), Amgen has received a worldwide, exclusive license to Arrowhead’s novel RNAi Olpasiran (previously referred to as AMG 890 or ARO-LPA) program. These RNAi molecules are designed to reduce elevated lipoprotein(a), which is a genetically validated, independent risk factor for atherosclerotic cardiovascular disease. Under the otherprior collaboration and license agreement (the “First Collaboration and License Agreement” or the “ARO-AMG1 Agreement”), Amgen received an option to a worldwide, exclusive license for ARO-AMG1, an RNAi therapy for an undisclosed genetically validated cardiovascular target. InUnder both agreements, Amgen is wholly responsible for clinical development and commercialization. Under the terms of the agreements taken together, the Company has received $35.0 million in upfront payments, $21.5 million in the form of an equity investment by Amgen in the Company’s Common Stock, and $30.0 million in milestone payments, and may receive up to an additional $400.0 million in remaining development, regulatory and sales milestone payments. The Company is further eligible to receive up to low double-digit royalties for sales of products under the Olpasiran Agreement. In July 2019, Amgen informed the Company that it would not be exercising its option for an exclusive license for ARO-AMG1, and as such, there will be no further milestone or royalty payments under the ARO-AMG1 Agreement.    

The Company has evaluated these agreements in accordance with FASB Topics 808 – Collaboration Arrangements and 606 - Revenue for Contracts from Customers. The Company has substantially completed its performance obligations under the Olpasiran Agreement and the ARO-AMG1 Agreement. Future milestones and royalties achieved will be recognized in their entirety when earned. In July 2020, Amgen initiated a Phase 2 clinical study of Olpasiran, which resulted in a $20.0 million milestone payment to the Company. During the three months ended December 31, 20202021 and 2019,2020, the Company recognized $0 and $0 of revenue associated with its agreement with Amgen, respectively.As of December 31, 2020,2021, there were $0 in contract assets recorded as accounts receivable and $0 contract liabilities recorded as current deferred revenue on the Company’s Consolidated Balance Sheets.

19


Janssen Pharmaceuticals, Inc.

On October 3, 2018, the Company entered into the Janssena License Agreement (the “Janssen License Agreement”) and the Janssena Research Collaboration and Option Agreement (the “Janssen Collaboration Agreement”) with Janssen, part of the Janssen Pharmaceutical Companies of Johnson & Johnson.  The Company also entered into a Stock Purchase Agreementstock purchase agreement with JJDC (“JJDC Stock Purchase Agreement”) with JJDC..  Under the Janssen License Agreement, Janssen has received a worldwide, exclusive license to the Company’s JNJ-3989 (ARO-HBV) program, the Company’s third-generation subcutaneously administered RNAi therapeutic candidate being developed as a potential therapy for patients with chronic hepatitis B virus infection. Beyond the Company’s Phase 1/2 study of JNJ-3989 (ARO-HBV), which the Company was responsible for completing, Janssen is also wholly responsible for clinical development and commercialization of JNJ-3989.  Under the Janssen Collaboration Agreement, Janssen will be able to select three new targets against which Arrowhead will develop clinical candidates.  These candidates are subject to certain restrictions and do not include candidates that already were in the Company’s pipeline.  The Company will perform discovery, optimization and preclinical research and development, entirely funded by Janssen, which on its own or in combination with Janssen development work, is sufficient to allow the filing of a U.S. Investigational New Drug applicationApplication or equivalent, at which time Janssen will have the option to take an exclusive license. If the option is exercised, Janssen will be wholly responsible for clinical development and commercialization of each optioned candidate.  Under the terms of the agreements taken together, the Company has received $175.0 million as an upfront payment, $75.0 million in the form of an equity investment by JJDC in Arrowhead Common Stock under the JJDC Stock Purchase Agreement, and two $25.0milestone and option payments totaling $70.0 million, milestone payments, and the Company may receive up to $1.6 billion in development and sales milestones payments for the Janssen License Agreement, and up to $1.9 billion in development and sales milestone payments for the three additional targets covered under the Janssen Collaboration Agreement. The Company is further eligible to receive tiered royalties on product sales up to mid-teens under the Janssen License Agreement and up to low teens under the Janssen Collaboration Agreement on product sales.  Agreement.

The Company has evaluated these agreements in accordance with the new revenue recognition standard that became effectiveFASB Topics 808 – Collaboration Arrangements and 606 - Revenue for the Company on October 1, 2018.  The adoption of the new revenue standard did not have a material impact on the balances reported when evaluated under the superseded revenue standard.Contracts from Customers.  At the inception of these agreements, the Company has identified one distinct performance obligation.  Regarding the Janssen License Agreement, the Company determined that the key deliverables included the license and certain R&D services including the Company’s responsibility to complete the Phase 1/2 study of JNJ-3989 (ARO-HBV) and the Company’s responsibility to ensure certain manufacturing of JNJ-3989 (ARO-HBV) drug product is completed and delivered to Janssen (the “Janssen R&D Services”).  Due to the specialized and unique nature of these Janssen R&D Services and their direct relationship with the license, the Company determined that these deliverables represent one distinct bundle and, thus, one performance obligation.  The Company also determined that Janssen’s option to require the Company to develop up to three new targets is not a material right and, thus, not a performance obligation at the onset of the agreement.  The consideration for this option is accounted for separately.

18


The Company determined the transaction price totaled approximately $252.6$252.7 million, which includes the upfront payment, the premium paid by JJDC for its equity investment in the Company, the two $25.0 million milestone payments earnedrelated to JNJ-3989 (ARO-HBV), and estimated payments for reimbursable Janssen R&D servicesServices to be performed.  The Company has allocated the total $252.6$252.7 million initial transaction price to its one distinct performance obligation for the JNJ-3989 (ARO-HBV) license and the associated Janssen R&D Services.  This revenueThe Company has recognized this transaction price in its entirety as of September 30, 2021, as its performance obligations were substantially completed. Future milestones and royalties achieved will be recognized using a proportional performance method (based on actual costs incurred versus total estimated costs incurred) beginning in October 2018 and ending as the Company’s efforts in overseeing the Phase 1/2 clinical trial are completed.their entirety when earned.  During the three months ended December 31, 20202021 and 2019,2020, the Company recognized approximately $0 and $12.7 million and $28.8 million of Revenuerevenue associated with this performance obligation, respectively. As of December 31, 2020,2021, there were $0 in contract assets recorded as accounts receivable, and $6.7 million$0 of contract liabilities recorded as current deferred revenue on the Company’s Consolidated Balance Sheets.  The $6.7 million of current deferred revenue is driven by the upfront payment, the premium paid by JJDC for its equity investment in the Company, and the two $25.0 million milestone payments earned, net of revenue recognized to date.

The Company has begun to conduct its discovery, optimization and preclinical research and development of ARO-JNJ1,JNJ-75220795 (ARO-JNJ1), ARO-JNJ2 and ARO-JNJ3 under the Janssen Collaboration Agreement.  All costs and labor hours spent by the Company will be entirely funded by Janssen. During the three months ended December 31, 2021 and 2020, and 2019, the Company recognized $0 and $0.3 million and $0.7 million of Revenuerevenue associated with these efforts, respectively.As of December 31 2020,, 2021, there were $0.8 million$0 of contract assets recorded as accounts receivable and $0 of contract liabilities recorded as current deferred revenue on the Company’s Consolidated Balance Sheets.

Takeda Pharmaceuticals U.S.A., Inc.

On October 7, 2020, the Company entered into Takedaan Exclusive License Agreementand Co-funding agreement (the “Takeda License Agreement”) with Takeda.  Under the Takeda License Agreement, Takeda and the Company will co-develop the Company’s ARO-AAT program, the Company’s second-generation subcutaneously administered RNAi therapeutic candidate being developed as a treatment for liver disease associated with alpha-1 antitrypsin deficiency. Within the United States, ARO-AAT, if approved, will be co-commercialized under a 50/50 profit sharing structure. Outside the United States, Takeda will lead the global commercialization strategy and will receive an exclusive license to commercialize ARO-AAT, withwhile the Company will be eligible to receive tiered royalties of 20% to 25% on net sales.  In January 2021, the Company received $300.0 million as an upfront payment and is eligible to receive potential development, regulatory and commercial milestones of up to $740.0 million.  

20


The Company has evaluated the Takeda License Agreement in accordance with the new revenue recognition requirements that became effectiveFASB Topics 808 – Collaborative Arrangements and 606 - Revenue for the Company on October 1, 2018. The adoption of the new revenue standard will not have a material impact on the balances reported when evaluated under the superseded revenue standard.Contracts from Customers. At the inception of the Takeda License Agreement, the Company has identified one distinct performance obligation.  The Company determined that the key deliverables included the license and certain R&D services including the Company’s responsibilities to complete the initial portion of the SEQUOIA study, to complete the ongoing Phase 2 AROAAT2002 study and to ensure certain manufacturing of ARO-AAT drug product is completed and delivered to Takeda (the “Takeda R&D Services”).  Due to the specialized and unique nature of these Takeda R&D services,Services and their direct relationship with the license, the Company determined that these deliverables represent one distinct bundle and, thus, one performance obligation.  Beyond the Takeda R&D Services, which are the responsibility of the Company, Takeda will be responsible for managing future clinical development and commercialization.commercialization outside the United States.  Within the United States, the Company will also participate in co-development and co-commercialization efforts and will co-fund these efforts with Takeda as part of the 50/50 profit sharing structure within the United States.  The Company will co-fund certainconsiders the collaborative activities, including the co-development and co-commercialization, to be a separate unit of the developmentaccount within Topic 808, and commercialization costs that Takeda manages, andas such, these co-funding amounts will be offset against amounts owed to Arrowhead, either from milestonesrecorded as Research and Development Expenses or royalties earned, or profits earned under the 50/50 profit sharing structure for U.S. commercialization.General and Administrative Expenses, as appropriate.

The Company determined the initial transaction price totaled approximately $300.0 million, which includes the upfront payment.  The Company will excludehas excluded any future estimated milestones royalties, or profit-sharing paymentsroyalties from this transaction price to date.  The Company will allocatehas allocated the total $300.0 million initial transaction price to its one distinct performance obligation for the ARO-AAT license and the associated Takeda R&D Services.  Revenue will be recognized using a proportional performance method (based on actual costs incurredpatient visits completed versus total estimated costs incurredvisits completed for the Takeda R&D Services)ongoing SEQUOIA and AROAAT2002 clinical studies). Revenue for the three months ended December 31, 2021 and 2020 was $20.8 million and 2019$8.2, respectively. As of December 31, 2021, there were $8.2$0 in contract assets recorded as accounts receivable, $82.0 million in contract liabilities recorded as deferred revenue and $106.5 million in contract liabilities recorded as deferred revenue, net of the current portion, and $2.9 million in contract liabilities recorded as accrued expenses.  The $2.9 million in accrued expenses was primarily driven by co-development and co-commercialization activities.

Horizon Therapeutics Ireland DAC

On June 18, 2021, the Company entered into the Horizon License Agreement with Horizon.  Under the Horizon License Agreement, Horizon received a worldwide exclusive license for ARO-XDH, a previously undisclosed discovery-stage investigational RNAi therapeutic being developed by the Company as a potential treatment for people with uncontrolled gout. The Company will conduct all activities through the preclinical stages of development of ARO-XDH, and Horizon will be wholly responsible for clinical development and commercialization of ARO-XDH. In July 2021, the Company received $40 million as an upfront payment and is eligible to receive up to $660 million in potential development, regulatory and sales milestones.  The Company is also eligible to receive royalties in the low- to mid-teens range on net product sales.  

The Company has evaluated the Horizon License Agreement in accordance with FASB Topics 808 – Collaborative Arrangements and 606 - Revenue for Contracts from Customers. At the inception of the Horizon License Agreement, the Company identified one distinct performance obligation.  The Company determined that the key deliverables included the license and certain R&D services, including the Company’s responsibilities to conduct all activities through the preclinical stages of development of ARO-XDH (the “Horizon R&D Services”).  Due to the specialized and unique nature of these Horizon R&D Services and their direct relationship with the license, the Company determined that these deliverables represented one distinct bundle and, thus, one performance obligation.  Beyond the Horizon R&D Services, which are the responsibility of the Company, Horizon will be responsible for managing future clinical development and commercialization of ARO-XDH.  

The Company determined the initial transaction price totaled $40.0 million, including the upfront payment.  The Company has excluded any future estimated milestones or royalties, from this transaction price to date.  The Company will allocate the total $40.0 million initial transaction price to its one distinct performance obligation for the ARO-XDH license and the associated Horizon R&D Services. Revenue will be recognized on a straight-line basis over the estimated timeframe for completing the Horizon R&D Services.  The Company determined that the straight-line basis was appropriate as its efforts will be expended evenly over the course of completing its performance obligation. Revenue for the three months ended December 31, 2021 and 2020 was $6.7 million and $0, respectively.  As of December 31, 2020,2021, there were $8.2$0.1 million in contract assets recorded as accounts receivable.receivable, $26.7 million in contract liabilities recorded as deferred revenue.    

Glaxosmithkline Intellectual Property (No. 3) Limited

On November 22, 2021, the Company entered into an Exclusive License Agreement (the “GSK License Agreement”) with GSK.  Under the GSK License Agreement, GSK has received an exclusive license for ARO-HSD, the Company’s investigational RNAi therapeutic being developed as a treatment for patients with alcohol-related and nonalcohol related liver diseases, such as

21


nonalcoholic steatohepatitis (NASH).  The exclusive license is worldwide with the exception of greater China, for which the Company will retain rights to develop and commercialize.  Beyond the Company’s Phase 1/2 study of (ARO-HSD), which the Company is responsible for completing, GSK is wholly responsible for clinical development and commercialization of ARO-HSD in its territory. Under the terms of the agreement, the Company has received an upfront payment of $120 million and is eligible for additional payments of $30 million at the start of Phase 2 and $100 million upon achieving a successful Phase 2 trial readout and the first patient dosed in a Phase 3 trial. Furthermore, should the Phase 3 trial read out positively, and the potential new medicine receives regulatory approval in major markets, the deal provides for commercial milestone payments to the Company of up to $190 million at first commercial sale, and up to $590 million in sales-related milestone payments. The Company is further eligible to receive tiered royalties on net product sales in a range of mid-teens to twenty percent.

The Company has evaluated the GSK License Agreement in accordance with FASB Topics 808 – Collaborative Arrangements and 606 - Revenue for Contracts from Customers. At the inception of the GSK License Agreement, the Company identified one distinct performance obligation.  The Company determined that the key deliverables included the license and certain R&D services, including the Company’s responsibility to complete the Phase 1/2 study, (the “GSK R&D Services”).  Due to the specialized and unique nature of these GSK R&D Services and their direct relationship with the license, the Company determined that these deliverables represented one distinct bundle and, thus, one performance obligation.  Beyond the GSK R&D Services, which are the responsibility of the Company, GSK will be responsible for managing future clinical development and commercialization in its territory.  

The Company determined the initial transaction price totaled $120.0 million, including the upfront payment. The Company has excluded any future estimated milestones or royalties from this transaction price to date.  The Company has allocated the total $120.0 million initial transaction price to its one distinct performance obligation for the ARO-HSD license and the associated GSK R&D Services.  Revenue will be recognized using a proportional performance method. As of December 31, 2021, no revenue or contract assets or liabilities were recognized as the GSK License Agreement had not yet completed customary closing conditions, including clearance by the relevant competition authorities.  This clearance was achieved in January 2022 and the upfront payment of $120.0 million was also received by the Company in January 2022.

Operating Expenses

The analysis below details the operating expenses and discusses the expenditures of the Company within the major expense categories. Certain reclassifications have been made to prior-period operating expense categories to conform to the current period presentation.  For purposes of comparison, the amounts for the three months ended December 31, 20202021 and 20192020 are shown in the tables below.

19


Research and Development Expenses

R&D expenses are related to the Company’s research and development efforts and related program costs, which are comprised primarily of outsourced costs related to the manufacturing of clinical supplies, toxicity/efficacy studies and clinical trial expenses.  Internal costs primarily relate to operations at our research facilities in Madison, Wisconsin and San Diego, California, including facility costs and laboratory-related expenses. Salaries and stock compensation expense consist of salary, bonuses, payroll taxes and related benefits and stock compensation for our R&D personnel.  Depreciation and amortization expense relates toconsist of depreciation on lab equipment and leasehold improvements at our research facilities.  We do not separately track R&D expenses by individual research and development projects, including by individual drug candidates. The Company operates in a cross-functional manner across projects and does not separately allocate facilities-related costs, candidate costs, discovery costs, compensation

22


expenses, depreciation and amortization expenses, and other expenses for research and development activities.  The following table provides details of research and development expenses for the periods indicated:

(table below in thousands)

 

Three

 

 

 

 

 

 

Three

 

 

 

 

 

 

 

 

 

Three

 

 

 

 

 

 

Three

 

 

 

 

 

 

 

 

 

Months

Ended

 

 

% of

Expense

 

 

Months

Ended

 

 

% of

Expense

 

 

Increase (Decrease)

 

 

Months

Ended

 

 

% of

Expense

 

 

Months

Ended

 

 

% of

Expense

 

 

Increase (Decrease)

 

 

December 31, 2020

 

 

Category

 

 

December 31, 2019

 

 

Category

 

 

$

 

 

%

 

 

December 31, 2021

 

 

Category

 

 

December 31, 2020

 

 

Category

 

 

$

 

 

%

 

Salaries

 

$

8,173

 

 

 

22

%

 

$

4,096

 

 

 

18

%

 

$

4,077

 

 

 

100

%

 

$

10,994

 

 

 

17

%

 

$

8,173

 

 

 

22

%

 

$

2,821

 

 

 

35

%

Facilities related

 

 

1,478

 

 

 

4

%

 

 

620

 

 

 

3

%

 

 

858

 

 

 

138

%

 

 

2,038

 

 

 

3

%

 

 

1,478

 

 

 

4

%

 

 

560

 

 

 

38

%

Candidate costs

 

 

15,017

 

 

 

41

%

 

 

13,430

 

 

 

58

%

 

 

1,587

 

 

��

12

%

 

 

32,345

 

 

 

49

%

 

 

15,017

 

 

 

41

%

 

 

17,328

 

 

 

115

%

R&D discovery costs

 

 

4,711

 

 

 

13

%

 

 

2,955

 

 

 

13

%

 

 

1,756

 

 

 

59

%

 

 

11,000

 

 

 

17

%

 

 

4,711

 

 

 

13

%

 

 

6,289

 

 

 

133

%

Total research and development

expense, excluding non-cash

expense

 

 

29,379

 

 

 

80

%

 

 

21,101

 

 

 

90

%

 

 

8,278

 

 

 

39

%

 

 

56,377

 

 

 

86

%

 

 

29,379

 

 

 

80

%

 

 

26,998

 

 

 

92

%

Stock compensation

 

 

5,486

 

 

 

15

%

 

 

1,162

 

 

 

5

%

 

 

4,324

 

 

 

372

%

 

 

7,218

 

 

 

11

%

 

 

5,486

 

 

 

15

%

 

 

1,732

 

 

 

32

%

Depreciation/amortization

 

 

1,690

 

 

 

5

%

 

 

1,111

 

 

 

5

%

 

 

579

 

 

 

52

%

 

 

2,170

 

 

 

3

%

 

 

1,690

 

 

 

5

%

 

 

480

 

 

 

28

%

Total research and development expense

 

$

36,555

 

 

 

100

%

 

$

23,374

 

 

 

100

%

 

$

13,181

 

 

 

56

%

 

$

65,765

 

 

 

100

%

 

$

36,555

 

 

 

100

%

 

$

29,210

 

 

 

80

%

 

Salaries expense increased by $4,077,000$2,821,000 from $4,096,000$8,173,000 during the three months ended December 31, 20192020 to $8,173,000$10,994,000 during the current period.  This increase is primarily due to an increase in R&D headcount that has occurred as the Company has expanded its pipeline of candidates. We anticipate this expense to continue to increase as we continue to expand our pipeline of candidates and increase headcount to support our discovery efforts to identify new drug candidates.

Facilities expense increased by $858,000$560,000 from $620,000$1,478,000 during the three months ended December 31, 20192020 to $1,478,000$2,038,000 during the current period. This category includes rental costs for our research and development facilities in Madison, Wisconsin and San Diego, California. ThisWe expect this expense to continue to increase is primarily due the commencement ofas we continue to build out our sublease in San Diego, California in April 2020.manufacturing capabilities to support our discovery efforts to identify new drug candidates.

Candidate costs increased by $1,587,000$17,328,000 from $13,430,000$15,017,000 during the three months ended December 31, 20192020 to $15,017,000$32,345,000 during the current period. This increase is primarily due to the progression of our pipeline of candidates into and through clinical trials, which results in higher outsourced clinical trial, toxicity study and manufacturing costs. For example, our cardiometabolic candidates, ARO-ANG3 and ARO-APOC3, have advanced into phase 2 and phase 3 clinical trials. We anticipate these expenses to continue to increase as our pipeline of candidates grows and progresses to later phase clinical trials.

R&D discovery costs increased by $1,756,000$6,289,000 from $2,955,000$4,711,000 during the three months ended December 31, 20192020 to $4,711,000$11,000,000 in the current period. This increase is primarily due to the growth of our discovery efforts, including the addition of our research facility in San Diego. We anticipate this expense to continue to increase as we increase headcount to support our discovery efforts to identify new drug candidates.

Stock compensation expense, a non-cash expense, increased by $4,324,000$1,732,000 from $1,162,000$5,486,000 during the three months ended December 31, 20192020 to $5,486,000$7,218,000 during the current period. Stock compensation expense is based upon the valuation of stock options and restricted stock units granted to employees, directors and certain consultants. Many variables affect the amount expensed, including the Company’s stock price on the date of the grant, as well as other assumptions. The increase in the expense in the current period is primarily due to the increased headcount discussed above and a mix of higher grant date fair values of awards amortizing during the current period due to the Company’s stock price at the time of the grants. We generally expect future stock compensation expense to continue to increase as our headcount continues to increase to support our clinical pipeline.  

Depreciation and amortization expense, a non-cash expense, increased by $579,000$480,000 from $1,111,000$1,690,000 during the three months ended December 31, 20192020 to $1,690,000$2,170,000 during the current period.  The majority of depreciation and amortization expense relates to depreciation on lab equipment and leasehold improvements at our Madison and San Diego research facility.facilities. The increase in depreciation and amortization expense is due to an increase in laboratory equipment and leasehold improvements. We expect this amount to increase in the future as we continue to purchase additional lab equipment to support our growing pipeline.

2023


General & Administrative Expenses

The following table provides details of our general and administrative expenses for the periods indicated:

(table below in thousands)

 

Three

 

 

 

 

 

 

Three

 

 

 

 

 

 

 

 

 

Three

 

 

 

 

 

 

Three

 

 

 

 

 

 

 

 

 

Months

Ended

 

 

% of

Expense

 

 

Months

Ended

 

 

% of

Expense

 

 

Increase (Decrease)

 

 

Months

Ended

 

 

% of

Expense

 

 

Months

Ended

 

 

% of

Expense

 

 

Increase (Decrease)

 

 

December 31, 2020

 

 

Category

 

 

December 31, 2019

 

 

Category

 

 

$

 

 

%

 

 

December 31, 2021

 

 

Category

 

 

December 31, 2020

 

 

Category

 

 

$

 

 

%

 

Salaries

 

$

2,584

 

 

 

29

%

 

$

4,081

 

 

 

37

%

 

$

(1,497

)

 

 

-37

%

 

$

3,430

 

 

 

14

%

 

$

2,584

 

 

 

29

%

 

$

846

 

 

 

33

%

Professional/outside services

 

 

1,982

 

 

 

23

%

 

 

1,822

 

 

 

17

%

 

 

160

 

 

 

9

%

 

 

2,177

 

 

 

9

%

 

 

1,982

 

 

 

23

%

 

 

195

 

 

 

10

%

Facilities related

 

 

730

 

 

 

8

%

 

 

793

 

 

 

7

%

 

 

(63

)

 

 

-8

%

 

 

680

 

 

 

3

%

 

 

421

 

 

 

5

%

 

 

259

 

 

 

62

%

Other G&A

 

 

694

 

 

 

8

%

 

 

760

 

 

 

7

%

 

 

(66

)

 

 

-9

%

 

 

1,018

 

 

 

4

%

 

 

1,003

 

 

 

11

%

 

 

15

 

 

 

1

%

Total general & administrative

expense, excluding non-cash

�� expense

 

 

5,990

 

 

 

68

%

 

 

7,456

 

 

 

1

 

 

 

(1,466

)

 

 

-45

%

Total general & administrative expense, excluding non-cash expense

 

 

7,305

 

 

 

29

%

 

 

5,990

 

 

 

68

%

 

 

1,315

 

 

 

22

%

Stock compensation

 

 

2,658

 

 

 

30

%

 

 

3,330

 

 

 

31

%

 

 

(672

)

 

 

-20

%

 

 

17,287

 

 

 

69

%

 

 

2,658

 

 

 

30

%

 

 

14,629

 

 

 

550

%

Depreciation/amortization

 

 

154

 

 

 

2

%

 

 

148

 

 

 

1

%

 

 

6

 

 

 

4

%

 

 

403

 

 

 

2

%

 

 

154

 

 

 

2

%

 

 

249

 

 

 

162

%

Total general & administrative expense

 

$

8,802

 

 

 

100

%

 

$

10,934

 

 

 

100

%

 

$

(2,132

)

 

 

-61

%

 

$

24,995

 

 

 

100

%

 

$

8,802

 

 

 

100

%

 

$

16,193

 

 

 

184

%

 

Salaries expense decreasedincreased by $1,497,000$846,000 from $4,081,000$2,584,000 during the three months ended December 31, 20192020 to $2,584,000$3,430,000 during the current period. The decreaseThis increase is primarily due to higher annual performance bonuses awardedan increase in December 2019.G&A headcount that has occurred as the Company has grown. We expect salaries expense to continue to increase as our headcount continues to increase to help support our expanding clinical pipeline.  

Professional/outside services include legal, accounting, consulting, patent expenses, business insurance expenses and other outside services retained by the Company. Professional/outside services expense increased by $160,000$195,000 from $1,822,000$1,982,000 during the three months ended December 31, 20192020 to $1,982,000$2,177,000 during the current period. The increase in professional/outside services expense is primarily related to the timing of certain patent-related expenses.

Facilities-related expense decreasedincreased by $63,000$259,000 from $793,000$421,000 during the three months ended December 31, 20192020 to $730,000$680,000 during the current period.  This category primarily includes rental costs for our corporate headquarters in Pasadena, California. The decrease in theWe expect future facilities-related expense in the current period is primarily related to the moving costsincrease as we incurred in the three months ended December 31, 2019continue to moveincrease our headcount to support our new corporate headquarters.     discovery efforts.

Other G&A expense decreasedincreased by $66,000$15,000 from $760,000$1,003,000 during the three months ended December 31, 20192020 to $694,000$1,018,000 during the current period. This category consists primarily of travel, communication and technology, office expenses, and franchise and property tax expenses.  The decrease in the expense wasincrease is due to decreased travel expenses.increased information technology costs to support the Company’s increased headcount.

Stock compensation expense, a non-cash expense, decreasedincreased by $672,000$14,629,000 from $3,330,000$2,658,000 during the three months ended December 31, 20192020 to $2,658,000$17,287,000 during the current period. Stock compensation expense is based upon the valuation of stock options and restricted stock units granted to employees, directors and certain consultants. Many variables affect the amount expensed, including the Company’s stock price on the date of the grant, as well as other assumptions. The increase in the current period is due to a performance award that was achieved earlier than anticipated, as well as a modification of certain performance awards to include market conditions. The fair value of market condition-based awards is expensed ratably over the service period and is not adjusted for actual achievement.We generally expect future stock compensation expense to continue to increase as our headcount continues to increase to help support our clinical pipeline.  

Depreciation and amortization expense, a noncash expense, increased by $6,000$249,000 from $148,000$154,000 during the three months ended December 31, 20192020 to $154,000$403,000 during the current period.  The increase is primarily related to amortization of leasehold improvements for our new corporate headquarters.

Other Income/Expense

Other income/expense was income of $2,180,000$3,322,000 during the three months ended December 31, 20192020 compared to income of $3,322,000$449,000 during the current period.  Other income is primarily related to interest income and realized and unrealized gain/loss on our marketable securities. The increasedecrease in other incomeincome/expense is consistent with the increase in our investment holdings.    due to lower yields on more recently purchased bonds.

2124


Liquidity and Capital Resources

Arrowhead has historically financed its operations through the sale of its equity securities.securities and revenue from its collaboration agreements. Research and development activities have required significant capital investment since the Company’s inception and are expected to continue to require significant cash expenditure as the Company’s pipeline continues to expand and matures into later stage clinical trials.  Additionally, the Company’s plans to expand its facilities with its purchase of land in Verona, Wisconsin, and its entry into a new lease in San Diego, California.  Each of these expansions is designed to increase the future.Company’s internal manufacturing and discovery capabilities, and each will require significant capital investment.

At December 31, 2020,2021, the Company had cash on hand of approximately $139.9$91.6 million as compared to $143.6$184.4 million at September 30, 2020.2021.  Cash invested in short-term fixed income securities and marketable securities was $165.4$238.5 million at December 31 2020,, 2021, compared to $171.9$183.4 million at September 30, 2020.2021.  Cash invested in long-term fixed income securities was $110.9$217.6 million at December 31 2020,, 2021, compared to $137.5$245.6 million at September 30, 2020.2021. The Company also entered into an Open Market Sale Agreement (the “ATM agreement”Agreement”), in August 2020, pursuant to which the Company may, from time to time, sell up to $250,000,000 in shares of the Company’s common stockCommon Stock through Jefferies LLC.  As of December 31, 2020,2021, no shares have been issuedsold under the ATM agreement.Agreement. The Company believes its current financial resources are sufficient to fund its operations through at least the next twelve months.

A summary of cash flows for the three months ended December 31, 20202021 and 20192020 is as follows:

 

 

 

Three Months Ended

 

Three Months Ended

 

 

 

December 31, 2020

 

December 31, 2019

 

 

 

(in thousands)

 

Cash Flow from:

 

 

 

 

 

 

 

Operating Activities

 

 

-38,922

 

 

-23,530

 

Investing Activities

 

 

30,158

 

 

9,280

 

Financing Activities

 

 

5,102

 

 

253,478

 

Net Increase (decrease) in cash and cash equivalents

 

 

-3,662

 

 

239,228

 

Cash and cash equivalents at beginning of period

 

 

143,583

 

 

221,804

 

Cash and cash equivalents at end of period

 

 

139,921

 

 

461,032

 

 

 

Three Months Ended

 

 

Three Months Ended

 

 

 

December 31, 2021

 

 

December 31, 2020

 

 

 

(in thousands)

 

Cash flow from:

 

 

 

 

 

 

 

 

Operating activities

 

 

(61,347

)

 

 

(38,922

)

Investing activities

 

 

(33,385

)

 

 

30,158

 

Financing activities

 

 

1,885

 

 

 

5,102

 

Net increase (decrease) in cash and cash equivalents

 

 

(92,847

)

 

 

(3,662

)

Cash and cash equivalents at beginning of period

 

 

184,434

 

 

 

143,583

 

Cash and cash equivalents at end of period

 

 

91,587

 

 

 

139,921

 

During the three months ended December 31, 2021, cash flow used by operating activities was $61.3 million, which was primarily due to ongoing expenses related to the Company’s research and development programs and general and administrative expenses. Cash used in investing activities was $33.4 million, which was primarily related to the purchase of property and equipment of $5.8 million and net purchase of investments of $27.6 million. Cash provided by financing activities of $1.9 million was related to cash received from stock option exercises.

 

During the three months ended December 31, 2020, the Company used $38.9 million in cash from operating activities, which was primarily related to the ongoing expenses of the Company’s research and development programs and general and administrative expenses. Cash provided in investing activities was $30.2 million, which was primarily related to the sale of marketable securities of $34.4 million, partially offset by the purchase of property and equipment of $4.3 million. Cash provided by financing activities of $5.1 million was related to cash received from stock option exercises.

 

During the three months endedOn December 31, 2019,20, 2021, the Company used $23.5completed a purchase of 13 acres of land in the Verona Technology Park in Verona, WI, which is planned to be the site of an approximately 140,000 square foot drug manufacturing facility and an approximately 115,000 square foot laboratory and office facility to support process development and analytical activities. Arrowhead intends to invest between $200 million in cash from operating activities, which was primarily related toand $250 million into the ongoing expensesbuildout of the Company’s researchfacilities. As part of this acquisition, the Company also entered into a development agreement with the City of Verona to construct certain infrastructure improvements within the TIF district, and development programs and general and administrative expenses.  Cash provided by investing activities was $9.3 million, which was primarily related to maturities of fixed-income investments of $13.6 million, partially offset by capital expenditures of $4.3 million.  Cash provided by financing activities of $253.5 million was drivenwill be reimbursed by the securities financing in December 2019, whichCity of Verona by future tax increment revenue generated $250.5 million in net cash proceeds,from the developed property. The total amount of funding that City of Verona will pay as well as $3.0 million in cash receivedreimbursements under the TIF program for these improvements is not guaranteed and will depend on future tax revenues generated from stock option exercises.the developed property.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

 

 


ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There has been no material change in our exposure to market risk from that described in Item 7A of our Annual Report on Form 10-K for the year ended September 30, 2020.2021.

ITEM 4.

CONTROLS AND PROCEDURES

Our Chief Executive Officer and our Chief Financial Officer, after evaluating our “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),) as of the end of the period covered by this Quarterly Report on Form 10-Q (the “Evaluation Date”), have concluded that, as of the Evaluation Date, our disclosure controls and procedures are effective to ensure that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SECSecurities and Exchange Commission rules and forms, and to ensure that information required to be disclosed by us in such reports is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer where appropriate, to allow timely decisions regarding required disclosure.

No change in the Company’s internal controls over financial reporting (as defined in RuleRules 13a-15(f) and 15d-15(f) of the Exchange Act) occurred during the Company’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 


PART II—OTHER INFORMATION

ITEM 1.

From time to time, we may be involved in routine legal proceedings, as well as demands, claims and threatened litigation, which arise in the normal course of our business. Litigation can be expensive and disruptive to normal business operations. Moreover, the results of legal proceedings, particularly complex legal proceedings, cannot be predicted with any certainty. We disclosed information about certain of ourThere have been no material developments in the legal proceedings that we disclosed in Part I, Item 3 of our Annual Report on Form 10-K for the year ended September 30, 2020.2021.  

ITEM 1A.

Risk Factors

There have been no material changes to the risk factors included in our Annual Report on Form 10-K for the year ended September 30, 2020.2021. Please carefully consider the information set forth in this Quarterly Report on Form 10-Q and the risk factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended September 30, 2020,2021, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K, as well as other risks and uncertainties, could materially and adversely affect our business, results of operations and financial condition, which in turn could materially and adversely affect the trading price of shares of our Common Stock. Additional risks not currently known or currently material to us may also harm our business.

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4.

MINE SAFETY DISCLOSURES

Not Applicable.

ITEM 5.

OTHER INFORMATION

None.

 

 

 


ITEM 6.

EXHIBITS

 

Exhibit
Number

 

Document Description

 

 

 

10.110.1*†

 

ExclusiveCollaboration and License and Co-Funding Agreement by and between Arrowhead Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc.,Glaxosmithkline Intellectual Property, dated October 7, 2020*November 22, 2021

 

 

 

10.210.2*†

 

Amendment No. 1 to Lease Agreement by and between Arrowhead Pharmaceuticals, Inc. and 177 Colorado Owner LLC.,ARE-SD Region No. 72, LLC, dated October 23, 2020*November 19, 2021.

 

 

 

10.3

 

Amendment No. 6 to LeaseForm of RSU Agreement byfor Officers and between ArrowheadCertain Other Employees (Arrowhead Pharmaceuticals, Inc. and University Research Park, dated November 23, 2020*2021 Incentive Plan- Inducement Award) (incorporated by reference from Exhibit 99.1 of the Company’s Form S-8 filed on December 22, 2021).

10.4

Form of RSU Agreement for Employees (Arrowhead Pharmaceuticals, Inc. 2021 Incentive Plan- Inducement Award) (incorporated by reference from Exhibit 99.2 of the Company’s Form S-8 filed on December 22, 2021).

10.5

Form of Stock Option Grant (Arrowhead Pharmaceuticals, Inc. 2021 Incentive Plan- Inducement Award) (incorporated by reference from Exhibit 99.3 of the Company’s Form S-8 filed on December 22, 2021).

 

 

 

10.410.6*†

31.1*

 

Amendment No. 7 to LeaseSeparation and Release of Claims Agreement by and between Arrowhead Pharmaceuticals, Inc. and University Research Park, dated December 9, 2020*James Hassard

 

31.1

Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*2002

 

 

 

31.231.2*

 

Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*2002

 

 

 

32.132.1**

 

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

 

 

 

32.232.2**

 

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

 

 

 

101.SCH101.INS*

 

Inline XBRL Taxonomy Extension Schema Document*Instance Document

 

 

 

101.CAL101.SCH*

Inline XBRL Taxonomy Extension Schema Document

101.CAL*

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document*Document

 

 

 

101.LAB101.LAB*

 

Inline XBRL Taxonomy Extension Label Linkbase Document*Document

 

 

 

101.PRE101.PRE*

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document*Document

 

 

 

101.DEF101.DEF*

 

Inline XBRL Taxonomy Extension Definition Linkbase Document*Document

 

 

 

104104*

 

The cover page from the Company’sthis Quarterly Report on Form 10-Q, for the quarter ended December 31, 2020, formatted in Inline XBRL (included as Exhibit 101)*

 

*

Filed herewithherewith.

**

Furnished herewithherewith.

Certain confidential portions of this exhibit were omitted by means of marking such portions with asterisks because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.

 

 

 


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Quarterly Report on Form 10-Q to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated: February 4, 20212, 2022

 

 

ARROWHEAD PHARMACEUTICALS, INC.

 

 

 

 

 

By:

 

/s/ Kenneth A. Myszkowski

 

 

 

Kenneth A. Myszkowski

Chief Financial Officer

 

 

 

(Principal Financial Officer and Duly Authorized Officer)

 

29

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