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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the quarterly period ended September 30, 2024

or

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

For the transition period from to

Commission File Number: 001-39059

img179650235_0.jpg

AVITA MEDICAL, INC.

(Exact name of registrant as specified in its charter)

Delaware

85-1021707

(State or other jurisdiction of

incorporation or organization)

(IRS Employer

Identification No.)

28159 Avenue Stanford

Suite 220

Valencia, CA 91355

(Address of principal executive offices and Zip Code)

Registrant’s telephone number, including area code: (661) 367-9170

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

Title of each class

 

Trading

Symbol

 

Name of each exchange

on which registered

Common Stock, par value $0.0001 per share

 

RCEL

 

The Nasdaq Stock Market LLC

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

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

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

Large accelerated filer

 

Accelerated filer

 

 

 

Non-accelerated filer

 

Smaller reporting company

 

 

 

Emerging growth company

 

 

 

If an emerging growth company, indicate by check mark if the registrant has selected 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, par value $0.0001, outstanding as of November 4, 2024 was 26,217,629

 

 


 

TABLE OF CONTENTS

 

NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

3

 

 

 

PART I – FINANCIAL INFORMATION

 

4

 

 

Item 1.

Financial Statements

 

4

 

 

Consolidated Balance Sheets – As of September 30, 2024 (unaudited) and December 31, 2023

 

4

 

 

Consolidated Statements of Operations for the three-months and nine-months ended September 30, 2024 and 2023 (unaudited)

 

5

 

 

Consolidated Statements of Comprehensive Loss for the three-months and nine-months ended September 30, 2024 and 2023 (unaudited)

 

6

 

 

Consolidated Statements of Stockholders’ Equity for the three-months and nine-months ended September 30, 2024 and 2023 (unaudited)

 

7

 

 

Consolidated Statements of Cash Flows for the nine-months ended September 30, 2024 and 2023 (unaudited)

 

9

 

 

Notes to Consolidated Financial Statements (unaudited)

 

10

 

 

Item 2.

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

 

27

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

32

 

 

Item 4.

Controls and Procedures

 

32

 

 

Part II – OTHER INFORMATION

 

34

 

 

Item 1.

Legal Proceedings

 

34

 

 

Item 1A

Risk Factors

 

34

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

34

 

 

Item 3.

Defaults Upon Senior Securities

 

34

 

 

Item 4.

Mine Safety Disclosures

 

34

 

 

Item 5.

Other Information

 

34

 

 

Item 6.

Exhibits

 

35

 

 

Signatures

 

36

 

 


 

NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future revenues; solvency; future industry market conditions; future changes in our capacity and operations; future operating and overhead costs; intellectual property; regulatory and related approvals; the conduct or outcome of pre-clinical or clinical (human) studies; operational and management restructuring activities (including implementation of methodologies and changes in the board of directors); our ability to expand our sales and marketing organizations to address effectively existing and new markets that we intend to target; future employment and contributions of personnel; tax and interest rates; productivity, business process, rationalization, investment, mergers and acquisitions (and related integration activities), consulting, operational, tax, financial and capital projects and/or initiatives; inflationary pressures on the U.S. and global economies, respectively; changes in the legal or regulatory environments; and future working capital, costs, revenues, business opportunities, cash flows, margins, earnings and growth. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

 

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” "would," “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other similar expressions.

 

The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described under the sections in this Quarterly Report on Form 10-Q titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

 

Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for our management to predict all risk factors and uncertainties.

 

You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

3


 

PART I – Financial Information

Item 1. FINANCIAL STATEMENTS

AVITA MEDICAL, INC.

Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)

 

 

 

As of

 

 

 

September 30, 2024

 

 

December 31, 2023

 

ASSETS

 

 

 

 

 

 

Cash and cash equivalents

 

$

18,639

 

 

$

22,118

 

Marketable securities

 

 

25,766

 

 

 

66,939

 

Accounts receivable, net

 

 

10,288

 

 

 

7,664

 

BARDA receivables

 

 

111

 

 

 

30

 

Prepaids and other current assets

 

 

2,892

 

 

 

1,659

 

Inventory

 

 

6,229

 

 

 

5,596

 

Total current assets

 

 

63,925

 

 

 

104,006

 

Plant and equipment, net

 

 

9,151

 

 

 

1,877

 

Operating lease right-of-use assets

 

 

3,780

 

 

 

2,440

 

Corporate-owned life insurance (“COLI”) asset

 

 

3,059

 

 

 

2,475

 

Intangible assets, net

 

 

590

 

 

 

487

 

Other long-term assets

 

 

546

 

 

 

355

 

Total assets

 

$

81,051

 

 

$

111,640

 

LIABILITIES, NON-QUALIFIED DEFERRED COMPENSATION PLAN SHARE AWARDS AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

4,187

 

 

$

3,793

 

Accrued wages and fringe benefits

 

 

9,776

 

 

 

7,972

 

Current non-qualified deferred compensation (“NQDC”) liability

 

 

1,870

 

 

 

168

 

Other current liabilities

 

 

1,308

 

 

 

1,266

 

Total current liabilities

 

 

17,141

 

 

 

13,199

 

Long-term debt

 

 

42,547

 

 

 

39,812

 

Non-qualified deferred compensation liability

 

 

2,742

 

 

 

3,663

 

Contract liabilities

 

 

332

 

 

 

357

 

Operating lease liabilities, long term

 

 

3,079

 

 

 

1,702

 

Warrant liability

 

 

2,759

 

 

 

3,158

 

Total liabilities

 

 

68,600

 

 

 

61,891

 

Non-qualified deferred compensation plan share awards

 

 

224

 

 

 

693

 

Commitments and contingencies (Note 11)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 26,217,629 and 25,682,078, shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively

 

 

3

 

 

 

3

 

Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at September 30, 2024 and December 31, 2023

 

 

-

 

 

 

-

 

Company common stock held by the non-qualified deferred compensation plan

 

 

(1,255

)

 

 

(1,130

)

Additional paid-in capital

 

 

363,769

 

 

 

350,039

 

Accumulated other comprehensive loss

 

 

(2,065

)

 

 

(1,887

)

Accumulated deficit

 

 

(348,225

)

 

 

(297,969

)

Total stockholders’ equity

 

 

12,227

 

 

 

49,056

 

Total liabilities, non-qualified deferred compensation plan share awards and stockholders’ equity

 

$

81,051

 

 

$

111,640

 

 

 

 

 

 

 

 

 

The accompanying notes form part of the unaudited Consolidated Financial Statements.

4


 

AVITA MEDICAL, INC.

Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Three-Months Ended

 

Nine-Months Ended

 

 

 

September 30, 2024

 

September 30, 2023

 

September 30, 2024

 

September 30, 2023

 

 

 

 

 

 

 

 

 

 

 

Sales revenue

 

$

19,394

 

$

13,645

 

$

45,681

 

$

35,948

 

Lease revenue

 

 

152

 

 

-

 

 

164

 

 

-

 

Total revenues

 

 

19,546

 

 

13,645

 

 

45,845

 

 

35,948

 

Cost of sales

 

 

(3,190

)

 

(2,113

)

 

(6,814

)

 

(5,984

)

Gross profit

 

 

16,356

 

 

11,532

 

 

39,031

 

 

29,964

 

BARDA income

 

 

-

 

 

212

 

 

-

 

 

1,369

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

(15,144

)

 

(10,532

)

 

(44,086

)

 

(27,075

)

General and administrative

 

 

(9,590

)

 

(6,124

)

 

(26,071

)

 

(20,584

)

Research and development

 

 

(5,428

)

 

(4,394

)

 

(15,510

)

 

(14,056

)

Total operating expenses

 

 

(30,162

)

 

(21,050

)

 

(85,667

)

 

(61,715

)

Operating loss

 

 

(13,806

)

 

(9,306

)

 

(46,636

)

 

(30,382

)

Interest expense

 

 

(1,359

)

 

(10

)

 

(4,063

)

 

(21

)

Other (expense) income, net

 

 

(1,068

)

 

615

 

 

478

 

 

2,141

 

Loss before income taxes

 

 

(16,233

)

 

(8,701

)

 

(50,221

)

 

(28,262

)

Income tax benefit (expense)

 

 

28

 

 

(11

)

 

(35

)

 

(54

)

Net loss

 

$

(16,205

)

$

(8,712

)

$

(50,256

)

$

(28,316

)

Net loss per common share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.62

)

$

(0.34

)

$

(1.95

)

$

(1.12

)

Weighted-average common shares:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

25,983,929

 

 

25,401,754

 

 

25,794,690

 

 

25,281,920

 

 

The accompanying notes form part of the unaudited Consolidated Financial Statements.

5


 

AVITA MEDICAL, INC.

Consolidated Statements of Comprehensive Loss

(In thousands)

(Unaudited)

 

 

Three-Months Ended

 

Nine-Months Ended

 

 

September 30, 2024

 

September 30, 2023

 

September 30, 2024

 

September 30, 2023

 

 

 

 

 

 

 

 

 

 

Net loss

$

(16,205

)

$

(8,712

)

$

(50,256

)

$

(28,316

)

Foreign currency translation loss

 

-

 

 

(47

)

 

-

 

 

(57

)

Change in fair value due to credit risk on long-term debt loss

 

(554

)

 

-

 

 

(116

)

 

-

 

Net unrealized gain/(loss) on marketable securities

 

45

 

 

65

 

 

(62

)

 

407

 

Comprehensive loss

$

(16,714

)

$

(8,694

)

$

(50,434

)

$

(27,966

)

 

The accompanying notes form part of the unaudited Consolidated Financial Statements.

6


 

AVITA MEDICAL, INC.

Consolidated Statements of Stockholders’ Equity

(In thousands, except shares)

(Unaudited)

 

 

 

Three-Months Ended September 30, 2024

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

Amount

 

Company common stock held by the NQDC Plan

 

Additional
Paid-in Capital

 

Accumulated Other
Comprehensive
Gain (Loss)

 

Accumulated
Deficit

 

Total
Stockholders’
Equity

 

Balance at June 30, 2024

 

25,949,906

 

$

3

 

$

(1,022

)

$

358,510

 

$

(1,556

)

$

(332,020

)

$

23,915

 

Net loss

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

(16,205

)

 

(16,205

)

Stock-based compensation

 

-

 

 

-

 

 

-

 

 

4,040

 

 

-

 

 

-

 

 

4,040

 

Vesting of restricted stock units

 

50,157

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

Exercise of stock options

 

183,867

 

 

-

 

 

-

 

 

1,008

 

 

-

 

 

-

 

 

1,008

 

Distribution/diversification of Company common stock held by the NQDC Plan

 

-

 

 

-

 

 

58

 

 

(2

)

 

-

 

 

-

 

 

56

 

Vesting of Company common stock held by the NQDC Plan

 

33,699

 

 

-

 

 

(291

)

 

291

 

 

-

 

 

-

 

 

-

 

Change in redemption value of share awards in NQDC Plan

 

-

 

 

-

 

 

-

 

 

(78

)

 

-

 

 

-

 

 

(78

)

Net unrealized gain on marketable securities

 

-

 

 

-

 

 

-

 

 

-

 

 

45

 

 

-

 

 

45

 

Change in fair value due to credit risk on long-term debt

 

-

 

 

-

 

 

-

 

 

-

 

 

(554

)

 

-

 

 

(554

)

Balance at September 30, 2024

 

26,217,629

 

$

3

 

$

(1,255

)

$

363,769

 

$

(2,065

)

$

(348,225

)

$

12,227

 

 

 

 

Three-Months Ended September 30, 2023

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

Amount

 

Company common stock held by the NQDC Plan

 

Additional
Paid-in Capital

 

Accumulated Other
Comprehensive
Gain (Loss)

 

Accumulated
Deficit

 

Total
Stockholders’
Equity

 

Balance at June 30, 2023

 

25,447,615

 

$

3

 

$

(892

)

$

343,769

 

$

7,959

 

$

(282,192

)

$

68,647

 

Net loss

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

(8,712

)

 

(8,712

)

Stock-based compensation

 

-

 

 

-

 

 

-

 

 

2,367

 

 

-

 

 

-

 

 

2,367

 

Exercise of stock options

 

17,221

 

 

-

 

 

-

 

 

110

 

 

-

 

 

-

 

 

110

 

Vesting of restricted stock units

 

45,336

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

Vesting of Company common stock held by the NQDC Plan

 

40,522

 

 

-

 

 

(636

)

 

636

 

 

-

 

 

-

 

 

-

 

Distribution of Company common stock held by the NQDC Plan

 

-

 

 

-

 

 

238

 

 

284

 

 

-

 

 

-

 

 

522

 

Change in redemption value of share awards in NQDC Plan

 

-

 

 

-

 

 

-

 

 

26

 

 

-

 

 

-

 

 

26

 

Net unrealized gain on marketable securities

 

-

 

 

-

 

 

-

 

 

-

 

 

65

 

 

-

 

 

65

 

Foreign currency translation gain

 

-

 

 

-

 

 

-

 

 

-

 

 

(47

)

 

-

 

 

(47

)

Balance at September 30, 2023

 

25,550,694

 

$

3

 

$

(1,290

)

$

347,192

 

$

7,977

 

$

(290,904

)

$

62,978

 

 

 

7


 

 

Nine-Months Ended September 30, 2024

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

Amount

 

Company common stock held by the NQDC Plan

 

Additional
Paid-in Capital

 

Accumulated Other
Comprehensive
Gain (Loss)

 

Accumulated
Deficit

 

Total
Stockholders’
Equity

 

Balance at December 31, 2023

 

25,682,078

 

$

3

 

$

(1,130

)

$

350,039

 

$

(1,887

)

$

(297,969

)

$

49,056

 

Net loss

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

(50,256

)

 

(50,256

)

Stock-based compensation

 

-

 

 

-

 

 

-

 

 

10,603

 

 

-

 

 

-

 

 

10,603

 

Vesting of restricted stock units

 

94,123

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

Exercise of stock options

 

301,524

 

 

-

 

 

-

 

 

1,701

 

 

-

 

 

-

 

 

1,701

 

ESPP purchase

 

96,253

 

 

-

 

 

-

 

 

786

 

 

-

 

 

-

 

 

786

 

Distribution/diversification of Company common stock held by the NQDC Plan

 

-

 

 

-

 

 

245

 

 

76

 

 

-

 

 

-

 

 

321

 

Vesting of Company common stock held by the NQDC Plan

 

43,651

 

 

-

 

 

(370

)

 

370

 

 

-

 

 

-

 

 

-

 

Change in redemption value of share awards in NQDC Plan

 

-

 

 

-

 

 

-

 

 

194

 

 

-

 

 

-

 

 

194

 

Net unrealized loss on marketable securities

 

-

 

 

-

 

 

-

 

 

-

 

 

(62

)

 

-

 

 

(62

)

Change in fair value due to credit risk on long-term debt

 

-

 

 

-

 

 

-

 

 

-

 

 

(116

)

 

-

 

 

(116

)

Balance at September 30, 2024

 

26,217,629

 

$

3

 

$

(1,255

)

$

363,769

 

$

(2,065

)

$

(348,225

)

$

12,227

 

 

 

Nine-Months Ended September 30, 2023

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

Amount

 

Company common stock held by the NQDC Plan

 

Additional
Paid-in Capital

 

Accumulated Other
Comprehensive
Gain (Loss)

 

Accumulated
Deficit

 

Total
Stockholders’
Equity

 

Balance at December 31, 2022

 

25,208,436

 

$

3

 

$

(127

)

$

339,825

 

$

7,627

 

$

(262,588

)

$

84,740

 

Net loss

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

(28,316

)

 

(28,316

)

Stock-based compensation

 

-

 

 

-

 

 

-

 

 

5,738

 

 

-

 

 

-

 

 

5,738

 

Exercise of stock options

 

163,750

 

 

-

 

 

-

 

 

942

 

 

-

 

 

-

 

 

942

 

Vesting of Company common stock held by the NQDC Plan

 

128,172

 

 

-

 

 

(1,401

)

 

1,401

 

 

-

 

 

-

 

 

-

 

Vesting of restricted stock units

 

50,336

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

Distribution of Company common stock held by the NQDC Plan

 

-

 

 

-

 

 

238

 

 

284

 

 

-

 

 

-

 

 

522

 

Change in redemption value of share awards in NQDC Plan

 

-

 

 

-

 

 

-

 

 

(998

)

 

-

 

 

-

 

 

(998

)

Foreign currency translation loss

 

-

 

 

-

 

 

-

 

 

-

 

 

(57

)

 

-

 

 

(57

)

Net unrealized gain on marketable securities

 

-

 

 

-

 

 

-

 

 

-

 

 

407

 

 

-

 

 

407

 

Balance at September 30, 2023

 

25,550,694

 

$

3

 

$

(1,290

)

$

347,192

 

$

7,977

 

$

(290,904

)

$

62,978

 

 

The accompanying notes form part of the unaudited Consolidated Financial Statements.

8


 

AVITA Medical, Inc.

Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Nine-Months Ended

 

 

 

September 30, 2024

 

 

September 30, 2023

 

Cash flow from operating activities:

 

 

 

 

 

 

Net loss

 

$

(50,256

)

 

$

(28,316

)

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

 

 

 

 

 

 

Change in fair value of long-term debt

 

 

2,619

 

 

 

-

 

Change in fair value of warrant liability

 

 

(399

)

 

 

-

 

Depreciation and amortization

 

 

717

 

 

 

445

 

Stock-based compensation

 

 

10,698

 

 

 

6,213

 

Non-cash lease expense

 

 

633

 

 

 

531

 

Loss on fixed asset disposal

 

 

25

 

 

 

83

 

Investment losses

 

 

-

 

 

 

17

 

Loss on patent disposal

 

 

16

 

 

 

4

 

Remeasurement and foreign currency transaction gain/(loss)

 

 

23

 

 

 

(23

)

Excess and obsolete inventory related charges

 

 

408

 

 

 

149

 

BARDA deferred costs

 

 

-

 

 

 

(147

)

Contract cost amortization

 

 

-

 

 

 

255

 

Provision for credit losses

 

 

33

 

 

 

113

 

Amortization of premium of marketable securities

 

 

(1,479

)

 

 

(794

)

Non-cash changes in the fair value of NQDC plan

 

 

36

 

 

 

899

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Trade and other receivables

 

 

(2,656

)

 

 

(2,473

)

BARDA receivables

 

 

(81

)

 

 

697

 

Prepaids and other current assets

 

 

(1,233

)

 

 

(2,057

)

Inventory

 

 

(1,041

)

 

 

(2,405

)

Operating lease liability

 

 

(667

)

 

 

(571

)

Corporate-owned life insurance (“COLI”) asset

 

 

(271

)

 

 

(643

)

Other long-term assets

 

 

(192

)

 

 

(114

)

Accounts payable and accrued expenses

 

 

(65

)

 

 

(70

)

Accrued wages and fringe benefits

 

 

1,804

 

 

 

524

 

Current non-qualified deferred compensation liability

 

 

1,625

 

 

 

(651

)

Other current liabilities

 

 

112

 

 

 

345

 

Non-qualified deferred compensation plan liability

 

 

(1,242

)

 

 

1,174

 

Contract liabilities

 

 

(25

)

 

 

(333

)

Net cash used in operations

 

$

(40,858

)

 

$

(27,148

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchase of marketable securities

 

 

(18,609

)

 

 

(7,633

)

Sale of marketable securities

 

 

-

 

 

 

2,372

 

Maturities of marketable securities

 

 

61,200

 

 

 

65,289

 

Purchase of plant and equipment

 

 

(7,559

)

 

 

(1,085

)

Patent filing fees

 

 

(140

)

 

 

(32

)

Net cash provided by investing activities

 

$

34,892

 

 

$

58,911

 

Cash flow from financing activities:

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

1,701

 

 

 

942

 

Employee stock purchase plan (“ESPP”) purchases

 

 

786

 

 

 

-

 

Net cash provided by financing activities

 

$

2,487

 

 

$

942

 

Effect of foreign exchange rate on cash and cash equivalents

 

 

-

 

 

 

(15

)

Net increase/(decrease) in cash and cash equivalents

 

 

(3,479

)

 

 

32,690

 

Cash and cash equivalents beginning of the period

 

$

22,118

 

 

$

18,164

 

Cash and cash equivalents end of the period

 

$

18,639

 

 

$

50,854

 

Supplemental Disclosure of Cash Flow Information:

 

 

 

 

 

 

Income taxes paid during the period

 

$

21

 

 

$

44

 

Interest paid during the period

 

$

4,062

 

 

$

21

 

Non-cash investing and financing activities:

 

 

 

 

 

 

Plant and equipment purchases not yet paid

 

$

407

 

 

$

114

 

Right-of-use-asset obtained in exchange for lease liabilities

 

$

2,026

 

 

$

-

 

 

The accompanying notes form part of the unaudited Consolidated Financial Statements.

9


 

AVITA MEDICAL, INC.

Notes to Consolidated Financial Statements

(Unaudited)

1. The Company

Nature of the Business

 

AVITA Medical, Inc. (collectively with its subsidiaries, “AVITA Medical”, “we”, “our”, “us”, or the “Company”) is a commercial-stage regenerative medicine company transforming the standard of care in wound management and skin restoration with innovative devices. At the forefront of the Company's portfolio is its patented and proprietary RECELL® technology (“RECELL”). RECELL harnesses the regenerative properties of a patient’s own skin to create an autologous skin cell suspension, Spray-On Skin Cells, delivering a transformative solution at the point of care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. The Company also holds the right to market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, in the United States under the terms of an exclusive multi-year distribution agreement with Stedical Scientific, Inc. (“Stedical”). The Company also entered into an exclusive multi-year development and distribution agreement with Regenity Biosciences (“Regenity”). Following 510(k) approval, Regenity will manufacture and supply Cohealyx, an AVITA-medical branded collagen-based dermal matrix. Under the agreement, the Company will hold the exclusive rights to market, sell, and distribute Cohealyx in the U.S., with potential expansion into the European Union, as well as in Australia and Japan.

 

The single-use RECELL Autologous Cell Harvesting Device (“RECELL Ease-of-Use” or “RECELL EOU”) is approved by the U.S. Food and Drug Administration (the “FDA”) for the treatment of thermal burn wounds and full-thickness skin defects, and repigmentation of stable depigmented vitiligo lesions. The Company's next-generation device, RECELL GO Autologous Cell Harvesting Device (“RECELL GO”), is FDA-approved to treat thermal burn wounds and full-thickness skin defects. RECELL GO introduces enhanced features that streamline the preparation of Spray-On Skin Cells and improves workflow efficiency in the operating room. It consists of two components: a multi-use, AC-powered RECELL GO Processing Device (the “RPD”) and a RECELL GO Preparation Kit (the “RPK”). The RPK contains the single-use RECELL GO Cartridge, disaggregation head, RECELL Enzyme, and other components. The RPD provides the control for the RPK, manages the pressure applied to disaggregate the donor skin cells, and precisely regulates the incubation times of the RECELL Enzyme and solutions to optimize cell yield and promote cell viability.

 

2. Summary of Significant Accounting Policies

 

Basis of Presentation

 

The accompanying unaudited Consolidated Financial Statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the Consolidated Financial Statements reflect all adjustments of a normal and recurring nature that are considered necessary for a fair presentation of the results for the interim periods presented. The information included in this quarterly report on Form 10-Q should be read in conjunction with the audited Consolidated Financial Statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year-ended December 31, 2023 filed with the SEC on February 22, 2024 and the Australian Securities Exchange (“ASX”) on February 23, 2024 (the “2023 Annual Report”).

 

Except for revenue recognition, related to the RECELL GO system, as described below, there have been no changes to the Company’s significant accounting policies as described in the 2023 Annual Report that have had a material impact on the Company’s Consolidated Financial Statements. See the summary of the Company’s significant accounting policies set forth in the notes to its Consolidated Financial Statements included in the 2023 Annual Report.

 

Principles of Consolidation

 

The accompanying Consolidated Financial Statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation.

 

Recent Accounting Pronouncements

 

In November 2023, the Financial Accounting Standards Board (the “FASB”) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU expands public entities’ segment disclosures by requiring

10


 

disclosure of significant segment expenses that are regularly reviewed by the Chief Operating Decision Maker (“CODM”) and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. The ASU also allows, in addition to the measure that is most consistent with GAAP, the disclosure of additional measures of segment profit or loss that are used by the CODM in assessing segment performance and deciding how to allocate resources. All disclosure requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its Consolidated Financial Statements and disclosures.

 

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments affected by this ASU require (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. These amendments are effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of adopting this ASU on its Consolidated Financial Statements and disclosures.

 

Use of Estimates

 

The preparation of the accompanying Consolidated Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts (including the stand-alone selling price (“SSP”) for the RPD, allowance for credit losses, reserves for inventory excess and obsolescence, carrying value of long-lived assets, the useful lives of long-lived assets, accounting for marketable securities, income taxes, fair value of debt, fair value of warrants and stock-based compensation) and related disclosures. Estimates have been prepared based on the current and available information. However, actual results could differ from estimated amounts.

 

Foreign Currency Translation and Foreign Currency Transactions

 

The financial position and results of operations of the Company’s operating non-U.S. subsidiaries are generally determined using the respective local currency as the functional currency of that subsidiary. Assets and liabilities of these subsidiaries are translated at the exchange rate in effect at each period end. Income statement accounts are translated at the average rate of exchange prevailing during the period. Adjustments arising from the use of differing exchange rates from period to period are included in Accumulated other comprehensive loss in the Consolidated Balance Sheets.

 

The Company’s non-operating subsidiaries that use the U.S. Dollar as their functional currency remeasure monetary assets and liabilities at exchange rates in effect at the end of each period and nonmonetary assets and liabilities at historical rates. Gains and losses resulting from these remeasurements are included in earnings in the Consolidated Statement of Operations. Gains and losses for remeasurement were minimal during the three-months and nine-months ended September 30, 2024 and 2023.

 

The Company records certain revenues and operating expenses in foreign currencies. These revenues and expenses are translated into U.S. Dollars based on the average exchange rate for the reporting period. Assets and liabilities denominated in foreign currencies are translated into U.S. Dollars at the exchange rate in effect as of the balance sheet date. For the three and nine-months ended September 30, 2024, the Company incurred approximately $11,000 and $23,000 in losses included in Net loss in the Consolidated Statement of Operations, respectively. For the three and nine-months ended September 30, 2023, the Company incurred approximately $26,000 and $23,000 in gains included in Net loss in the Consolidated Statement of Operations, respectively.

 

Cash and Cash Equivalents

 

Cash and cash equivalents consist of cash held at deposit institutions and cash equivalents. Cash equivalents consist primarily of money market funds. Cash equivalents also include short-term highly liquid investments with original maturities of three months or less from the date of purchase. The Company holds cash at deposit institutions in the amount of $5.3 million and $10.7 million as of September 30, 2024 and December 31, 2023, respectively. The Company does not have cash on deposit denominated in foreign currency in foreign institutions as of September 30, 2024. As of December 31, 2023, the Company had $69,000 of cash on deposit denominated in foreign currencies in foreign institutions. As of September 30, 2024 and December 31, 2023, the Company held cash equivalents in the amounts of $13.3 million and $11.4 million, respectively.

 

Rabbi Trust

 

During April 2022, the Company established a rabbi trust to hold the assets of the NQDC Plan. The rabbi trust holds the COLI asset and the Common stock from deferred restricted stock unit awards that have vested. The NQDC Plan permits

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diversification of fully vested shares into other equity securities subject to a six-month-and-one-day holding period. In accordance with ASR 268, Redeemable Preferred Stock, and ASC 718, Compensation — Stock Compensation, prior to vesting, the deferred share awards are classified as an equity instrument and changes in fair value of the amount owed to the participant are not recognized. The redemption amounts of the deferred awards are based on the vested percentage and are recorded outside of permanent equity as Non-qualified deferred compensation share awards on the Consolidated Balance Sheets. Common stock held in the rabbi trust is classified in a manner similar to treasury stock and presented separately on the Consolidated Balance Sheets as Company common stock held by the NQDC plan. As of September 30, 2024 and December 31, 2023, a total of 91,026 and 81,052 shares awards have been deferred, respectively. Vested shares are converted to Common stock and are reclassified to permanent equity.

 

Concentrations

 

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, marketable securities, trade receivables, and debt and other liabilities. As of September 30, 2024 and December 31, 2023, substantially all the Company’s cash and cash equivalents were deposited in accounts at financial institutions, and those deposited amounts exceed federally insured limits and are subject to the risk of bank failure.

 

As of September 30, 2024 and December 31, 2023, no single commercial customer accounted for more than 10% of net accounts receivable or more than 10% of revenues for the three-months and nine-months ended September 30, 2024 and 2023.