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 March 31,September 30, 2022

or

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

For the transition period from                     to                     

Commission File Number: 001-39059

 

 

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 NASDAQNasdaq Stock Market LLC

Securities registered pursuant to section 12(g) of the Act:

None

 

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 $0.0001 par value common stock outstanding as of May 1,November 7, 2022 was 24,955,58125,030,902

DCP

 


 

TABLE OF CONTENTS

 

FORWARD-LOOKING STATEMENT

3

 

 

PART I – FINANCIAL INFORMATION

4

 

 

 

Item 1.

Financial Statements

4

 

 

 

 

 

Consolidated Balance Sheets – March 31,September 30, 2022 (unaudited) and December 31, 2021

4

 

 

 

 

Consolidated Statements of Operations for the three monthsand nine-months ended March 31,September 30, 2022 and 2021 (unaudited)

5

 

 

 

 

Consolidated Statements of Comprehensive Loss for the three monthsand nine-months ended March 31,September 30, 2022 and 2021 (unaudited)

6

 

 

 

 

Consolidated Statements of Shareholders’ Equity for the three monthsand nine-months ended March 31,September 30, 2022 and 2021 (unaudited)

7

 

 

 

 

Consolidated Statements of Cash Flows for the three monthsnine-months ended March 31,September 30, 2022 and 2021 (unaudited)

8

9

 

 

 

 

Notes to Consolidated Financial Statements (unaudited)

9

10

 

 

 

Item 2.

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

30

33

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

38

 

 

 

Item 4.

Controls and Procedures

34

38

 

 

Part II – OTHER INFORMATION

35

39

 

 

 

Item 1.

Legal Proceedings

35

39

 

 

 

Item 1A.1A

Risk Factors

35

39

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

35

39

 

 

 

Item 3.

Defaults Upon Senior Securities

35

39

 

 

 

Item 4.

Mine Safety Disclosures

35

39

 

 

 

Item 5.

Other Information

35

39

 

 

 

Item 6.

Exhibits

36

40

 

 

Signatures

37

41

 

 

 


 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENT

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); future employment and contributions of personnel; effects on the global economy of the ongoing COVID-19 pandemic, including effects on the economy of existing and future variants on the original COVID-19 strain; tax and interest rates; productivity, business process, rationalization, investment, acquisition and acquisition integrations, consulting, operational, tax, financial and capital projects and initiatives; inflationary pressures on the U.S. and global economy; changes in the legal or regulatory environment; 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, “anticipate,” “could,” “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.  

 


 

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

 

 

As of

 

 

March 31, 2022

 

 

December 31, 2021

 

 

September 30, 2022

 

 

December 31, 2021

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

23,535

 

 

$

55,511

 

 

$

23,613

 

 

$

55,511

 

Marketable securities

 

 

59,835

 

 

 

29,649

 

 

 

60,559

 

 

 

29,649

 

Accounts receivable, net

 

 

3,481

 

 

 

3,118

 

 

 

3,553

 

 

 

3,118

 

BARDA receivables

 

 

682

 

 

 

308

 

 

 

792

 

 

 

308

 

Prepaids and other current assets

 

 

1,146

 

 

 

1,213

 

 

 

1,041

 

 

 

1,213

 

Restricted cash

 

 

201

 

 

 

201

 

 

 

202

 

 

 

201

 

Inventory

 

 

1,803

 

 

 

2,132

 

 

 

1,960

 

 

 

2,132

 

Total current assets

 

 

90,683

 

 

 

92,132

 

 

 

91,720

 

 

 

92,132

 

Marketable securities, long-term

 

 

11,684

 

 

 

19,692

 

 

 

4,012

 

 

 

19,692

 

Plant and equipment, net

 

 

1,171

 

 

 

1,262

 

 

 

1,226

 

 

 

1,262

 

Operating lease right-of-use assets

 

 

1,375

 

 

 

1,544

 

 

 

1,029

 

 

 

1,544

 

Corporate-owned life insurance asset

 

 

948

 

 

 

304

 

Intangible assets, net

 

 

416

 

 

 

443

 

 

 

449

 

 

 

443

 

Other long-term assets

 

 

1,162

 

 

 

942

 

 

 

548

 

 

 

638

 

Total assets

 

$

106,491

 

 

$

116,015

 

 

$

99,932

 

 

$

116,015

 

LIABILITIES AND SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

 

2,397

 

 

 

2,708

 

 

 

3,118

 

 

 

2,708

 

Accrued wages and fringe benefits

 

 

2,914

 

 

 

5,363

 

 

 

4,776

 

 

 

5,363

 

Other current liabilities

 

 

1,186

 

 

 

1,075

 

 

 

1,619

 

 

 

1,075

 

Total current liabilities

 

 

6,497

 

 

 

9,146

 

 

 

9,513

 

 

 

9,146

 

Non-qualified deferred compensation plan liability

 

 

1,016

 

 

 

262

 

Contract liabilities

 

 

882

 

 

 

952

 

 

 

740

 

 

 

952

 

Operating lease liabilities, long-term

 

 

726

 

 

 

918

 

 

 

405

 

 

 

918

 

Other long-term liabilities

 

 

571

 

 

 

375

 

 

 

-

 

 

 

113

 

Total liabilities

 

 

8,676

 

 

 

11,391

 

 

$

11,674

 

 

$

11,391

 

Non-qualified deferred compensation plan share awards

 

 

272

 

 

 

-

 

Contingencies (Note 12)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shareholders' Equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 24,955,581

and 24,925,743 shares issued and outstanding at March 31, 2022 and December 31, 2021,

respectively

 

 

3

 

 

 

3

 

Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, 0 shares

issued or outstanding at March 31, 2022 and December 31, 2021

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 25,030,902 and 24,925,743 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

 

3

 

 

 

3

 

Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at September 30, 2022 and December 31, 2021

 

 

-

 

 

 

-

 

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

 

 

(127

)

 

 

-

 

Additional paid-in capital

 

 

335,417

 

 

 

332,484

 

 

 

337,995

 

 

 

332,484

 

Accumulated other comprehensive income

 

 

7,781

 

 

 

8,060

 

 

 

7,350

 

 

 

8,060

 

Accumulated deficit

 

 

(245,386

)

 

 

(235,923

)

 

 

(257,235

)

 

 

(235,923

)

Total shareholders' equity

 

 

97,815

 

 

 

104,624

 

 

$

87,986

 

 

$

104,624

 

Total liabilities and shareholders' equity

 

$

106,491

 

 

$

116,015

 

 

$

99,932

 

 

$

116,015

 

 

The accompanying notes form part of the unaudited consolidated financial statements.


AVITA MEDICAL, INC.

Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

Three Months Ended March 31,

 

 

Three-Months Ended September 30,

 

 

Nine-Months Ended September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenues

 

$

7,539

 

 

$

8,765

 

 

$

9,092

 

 

$

7,020

 

 

$

24,966

 

 

$

26,089

 

Cost of sales

 

 

(1,778

)

 

 

(2,146

)

 

 

(1,530

)

 

 

(1,088

)

 

 

(4,694

)

 

 

(5,287

)

Gross profit

 

 

5,761

 

 

 

6,619

 

 

 

7,562

 

 

 

5,932

 

 

 

20,272

 

 

 

20,802

 

BARDA income

 

 

734

 

 

 

570

 

 

 

904

 

 

 

374

 

 

 

2,189

 

 

 

1,384

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing expenses

 

 

(4,828

)

 

 

(3,649

)

 

 

(5,411

)

 

 

(3,518

)

 

 

(15,571

)

 

 

(11,313

)

General and administrative expenses

 

 

(7,534

)

 

 

(5,422

)

 

 

(5,004

)

 

 

(5,349

)

 

 

(18,009

)

 

 

(16,046

)

Research and development expenses

 

 

(3,620

)

 

 

(4,109

)

 

 

(3,799

)

 

 

(3,388

)

 

 

(10,478

)

 

 

(11,471

)

Total operating expenses

 

 

(15,982

)

 

 

(13,180

)

 

 

(14,214

)

 

 

(12,255

)

 

 

(44,058

)

 

 

(38,830

)

Operating loss

 

 

(9,487

)

 

 

(5,991

)

 

 

(5,748

)

 

 

(5,949

)

 

 

(21,597

)

 

 

(16,644

)

Interest expense

 

 

-

 

 

 

(3

)

 

 

(6

)

 

 

(9

)

 

 

(10

)

 

 

(21

)

Other income

 

 

28

 

 

 

7

 

 

 

170

 

 

 

16

 

 

 

307

 

 

 

25

 

Loss before income taxes

 

 

(9,459

)

 

 

(5,987

)

 

 

(5,584

)

 

 

(5,942

)

 

 

(21,300

)

 

 

(16,640

)

Income tax expense

 

 

(4

)

 

 

(10

)

 

 

(4

)

 

 

(6

)

 

 

(12

)

 

 

(23

)

Net loss

 

$

(9,463

)

 

$

(5,997

)

 

$

(5,588

)

 

$

(5,948

)

 

$

(21,312

)

 

$

(16,663

)

Net loss per common share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.38

)

 

$

(0.26

)

 

$

(0.22

)

 

$

(0.24

)

 

$

(0.85

)

 

$

(0.69

)

Diluted

 

$

(0.38

)

 

$

(0.26

)

 

$

(0.22

)

 

$

(0.24

)

 

$

(0.85

)

 

$

(0.69

)

Weighted-average common shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

24,937,999

 

 

 

22,734,335

 

 

 

25,006,995

 

 

 

24,905,403

 

 

 

24,972,331

 

 

 

24,174,811

 

Diluted

 

 

24,937,999

 

 

 

22,734,335

 

 

 

25,006,995

 

 

 

24,905,403

 

 

 

24,972,331

 

 

 

24,174,811

 

The accompanying notes form part of the unaudited consolidated financial statements.

 


 

AVITA MEDICAL, INC.

Consolidated Statements of Comprehensive Loss

(In thousands)

(Unaudited)

 

 

Three Months Ended March 31,

 

 

Three-Months Ended September 30,

 

 

Nine-Months Ended September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss

 

$

(9,463

)

 

$

(5,997

)

 

$

(5,588

)

 

$

(5,948

)

 

$

(21,312

)

 

$

(16,663

)

Change in foreign currency translation gain/(loss)

 

 

18

 

 

 

(18

)

Change in foreign currency translation loss

 

 

(96

)

 

 

(50

)

 

 

(188

)

 

 

(80

)

Change in net unrealized loss on marketable securities, net of tax

 

 

(297

)

 

 

-

 

 

 

(90

)

 

 

(10

)

 

 

(522

)

 

 

(10

)

Comprehensive loss

 

$

(9,742

)

 

$

(6,015

)

 

$

(5,774

)

 

$

(6,008

)

 

$

(22,022

)

 

$

(16,753

)

 

The accompanying notes form part of the unaudited consolidated financial statements.  


AVITA MEDICAL, INC.

Consolidated Statements of Shareholders’ Equity

(In thousands, except shares)

(Unaudited)

 

 

Three Months Ended March 31, 2022

 

 

Three-Months Ended September 30, 2022

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-in Capital

 

 

Accumulated Other

Comprehensive

Gain (Loss)

 

 

Accumulated

Deficit

 

 

Total

Shareholders'

Equity

 

 

Shares

 

 

Amount

 

 

Company common stock held by the NQDC

 

 

Additional

Paid-in Capital

 

 

Accumulated Other

Comprehensive

Gain (Loss)

 

 

Accumulated

Deficit

 

 

Total

Shareholders'

Equity

 

Balance at December 31, 2021

 

 

24,925,743

 

 

$

3

 

 

$

332,484

 

 

$

8,060

 

 

$

(235,923

)

 

$

104,624

 

Balance at June 30, 2022

 

 

25,003,088

 

 

$

3

 

 

$

-

 

 

$

336,668

 

 

$

7,536

 

 

$

(251,647

)

 

$

92,560

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(9,463

)

 

 

(9,463

)

 

 

-

 

 

 

-

 

 

 

 

 

 

 

-

 

 

 

-

 

 

 

(5,588

)

 

 

(5,588

)

Share-based compensation

 

 

-

 

 

 

-

 

 

 

2,932

 

 

 

-

 

 

 

-

 

 

 

2,932

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,229

 

 

 

-

 

 

 

-

 

 

 

1,229

 

Exercise of stock options

 

 

125

 

 

 

-

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

1

 

Vesting of restricted stock units

 

 

29,713

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

9,887

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Company common stock held by the NQDC

 

 

17,927

 

 

 

-

 

 

 

(127

)

 

 

127

 

 

 

-

 

 

 

-

 

 

 

-

 

Change in redemption value of share awards in NQDC plan

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(29

)

 

 

-

 

 

 

-

 

 

 

(29

)

Other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(279

)

 

 

-

 

 

 

(279

)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(186

)

 

 

-

 

 

 

(186

)

Balance at March 31, 2022

 

 

24,955,581

 

 

$

3

 

 

$

335,417

 

 

$

7,781

 

 

$

(245,386

)

 

$

97,815

 

Balance at September 30, 2022

 

 

25,030,902

 

 

$

3

 

 

$

(127

)

 

$

337,995

 

 

$

7,350

 

 

$

(257,235

)

 

$

87,986

 

 

 

 

Three Months Ended March 31, 2021

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-in Capital

 

 

Accumulated Other

Comprehensive

Gain (Loss)

 

 

Accumulated

Deficit

 

 

Total

Shareholders'

Equity

 

Balance at December 31, 2020

 

 

21,625,058

 

 

$

3

 

 

$

262,086

 

 

$

8,289

 

 

$

(210,781

)

 

$

59,597

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,997

)

 

 

(5,997

)

Issuance of common stock under direct placement

 

 

3,214,250

 

 

 

 

 

 

 

69,106

 

 

 

 

 

 

 

 

 

 

 

69,106

 

Issuance costs associated with direct placement

 

 

 

 

 

 

 

 

 

 

(5,109

)

 

 

 

 

 

 

 

 

 

 

(5,109

)

Share-based compensation

 

 

-

 

 

 

-

 

 

 

1,333

 

 

 

-

 

 

 

-

 

 

 

1,333

 

Exercise of stock options

 

 

3,575

 

 

 

-

 

 

 

31

 

 

 

-

 

 

 

-

 

 

 

31

 

Translation gain

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(18

)

 

 

-

 

 

 

(18

)

Balance at March 31, 2021

 

 

24,842,883

 

 

$

3

 

 

$

327,447

 

 

$

8,271

 

 

$

(216,778

)

 

$

118,943

 

 

 

Three-Months Ended September 30, 2021

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Company common stock held by the NQDC

 

 

Additional

Paid-in Capital

 

 

Accumulated Other

Comprehensive

Gain (Loss)

 

 

Accumulated

Deficit

 

 

Total

Shareholders'

Equity

 

Balance at June 30, 2021

 

 

24,895,864

 

 

$

3

 

 

$

-

 

 

$

328,889

 

 

$

8,259

 

 

$

(221,496

)

 

$

115,655

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,948

)

 

 

(5,948

)

Share-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

1,842

 

 

 

-

 

 

 

-

 

 

 

1,842

 

Exercise of stock options

 

 

500

 

 

 

-

 

 

 

-

 

 

 

3

 

 

 

-

 

 

 

-

 

 

 

3

 

Vesting of restricted stock units

 

 

28,754

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(60

)

 

 

-

 

 

 

(60

)

Balance at September 30, 2021

 

 

24,925,118

 

 

$

3

 

 

$

-

 

 

$

330,734

 

 

$

8,199

 

 

$

(227,444

)

 

$

111,492

 

 

 

Nine-Months Ended September 30, 2022

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Company common stock held by the NQDC

 

 

Additional

Paid-in Capital

 

 

Accumulated Other

Comprehensive

Gain (Loss)

 

 

Accumulated

Deficit

 

 

Total

Shareholders'

Equity

 

Balance at December 31, 2021

 

 

24,925,743

 

 

$

3

 

 

$

-

 

 

$

332,484

 

 

$

8,060

 

 

$

(235,923

)

 

$

104,624

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(21,312

)

 

 

(21,312

)

Share-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,495

 

 

 

-

 

 

 

-

 

 

 

5,495

 

Exercise of stock options

 

 

125

 

 

 

-

 

 

 

-

 

 

 

1

 

 

 

-

 

 

 

-

 

 

 

1

 

Vesting of restricted stock units

 

 

87,107

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Company common stock held by the NQDC

 

 

17,927

 

 

 

-

 

 

 

(127

)

 

 

127

 

 

 

-

 

 

 

-

 

 

 

-

 

Change in classification of deferred compensation share awards

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(192

)

 

 

-

 

 

 

-

 

 

 

(192

)

Change in redemption value of share awards in NQDC plan

 

 

-

 

 

 

-

 

 

 

-

 

 

 

80

 

 

 

-

 

 

 

-

 

 

 

80

 

Other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(710

)

 

 

-

 

 

 

(710

)

Balance at September 30, 2022

 

 

25,030,902

 

 

$

3

 

 

$

(127

)

 

$

337,995

 

 

$

7,350

 

 

$

(257,235

)

 

$

87,986

 


 

 

Nine-Months Ended September 30, 2021

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Company common stock held by the NQDC

 

 

Additional

Paid-in Capital

 

 

Accumulated Other

Comprehensive

Gain (Loss)

 

 

Accumulated

Deficit

 

 

Total

Shareholders'

Equity

 

Balance at December 31, 2020

 

 

21,625,058

 

 

$

3

 

 

$

-

 

 

$

262,086

 

 

$

8,289

 

 

$

(210,781

)

 

$

59,597

 

Net loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(16,663

)

 

 

(16,663

)

Issuance of common stock under direct placement

 

 

3,214,250

 

 

 

-

 

 

 

-

 

 

 

69,106

 

 

 

-

 

 

 

-

 

 

 

69,106

 

Issuance costs associated with direct placement

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(5,109

)

 

 

-

 

 

 

-

 

 

 

(5,109

)

Share-based compensation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

4,585

 

 

 

-

 

 

 

-

 

 

 

4,585

 

Exercise of stock options

 

 

9,550

 

 

 

-

 

 

 

-

 

 

 

66

 

 

 

-

 

 

 

-

 

 

 

66

 

Vesting of RSU awards

 

 

76,260

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Other comprehensive loss

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(90

)

 

 

-

 

 

 

(90

)

Balance at September 30, 2021

 

 

24,925,118

 

 

$

3

 

 

$

-

 

 

$

330,734

 

 

$

8,199

 

 

$

(227,444

)

 

$

111,492

 

 

The accompanying notes form part of the unaudited consolidated financial statements.


AVITA Medical, Inc.

Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

Three Months Ended

 

 

Nine-Months Ended

 

 

March 31, 2022

 

 

March 31, 2021

 

 

September 30, 2022

 

 

September 30, 2021

 

Cash flow from operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(9,463

)

 

$

(5,997

)

 

$

(21,312

)

 

$

(16,663

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

163

 

 

 

167

 

 

 

438

 

 

 

517

 

Share-based compensation

 

 

2,932

 

 

 

1,333

 

 

 

5,782

 

 

 

4,585

 

Non-cash lease expense

 

 

169

 

 

 

156

 

 

 

515

 

 

 

477

 

Remeasurement and foreign currency transaction loss

 

 

37

 

 

 

8

 

Loss on fixed asset disposal

 

 

3

 

 

 

130

 

Patent impairment loss

 

 

-

 

 

 

19

 

Remeasurement and foreign currency transaction gain

 

 

(121

)

 

 

(28

)

Excess and obsolete inventory related charges

 

 

97

 

 

 

243

 

 

 

284

 

 

 

288

 

BARDA deferred costs

 

 

12

 

 

 

198

 

 

 

(12

)

 

 

343

 

Contract cost amortization

 

 

85

 

 

 

50

 

 

 

253

 

 

 

211

 

Provision (benefit) for doubtful accounts

 

 

1

 

 

 

(1

)

Provision for doubtful accounts

 

 

10

 

 

 

21

 

Amortization of premium of marketable securities

 

 

50

 

 

 

-

 

 

 

(12

)

 

 

36

 

Non-cash changes in the fair value of NQDC plan

 

 

(5

)

 

 

-

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade and other receivables

 

 

(362

)

 

 

(289

)

 

 

(449

)

 

 

(1,197

)

BARDA receivables

 

 

(373

)

 

 

(2,810

)

 

 

(484

)

 

 

(163

)

Prepaids and other current assets

 

 

67

 

 

 

(544

)

 

 

168

 

 

 

(316

)

Inventory

 

 

232

 

 

 

251

 

 

 

(119

)

 

 

107

 

Operating lease liability

 

 

(173

)

 

 

(161

)

 

 

(531

)

 

 

(492

)

Corporate-owned life insurance asset

 

 

(840

)

 

 

-

 

Other long-term assets

 

 

(305

)

 

 

(528

)

 

 

(163

)

 

 

(763

)

Accounts payable and accrued expenses

 

 

(294

)

 

 

827

 

 

 

433

 

 

 

(336

)

Accrued wages and fringe benefits

 

 

(2,450

)

 

 

(1,833

)

 

 

(570

)

 

 

(635

)

Other current liabilities

 

 

15

 

 

 

(14

)

 

 

511

 

 

 

70

 

Non-qualified deferred compensation plan liability

 

 

829

 

 

 

-

 

Contract liabilities

 

 

(70

)

 

 

403

 

 

 

(212

)

 

 

422

 

Other long-term liabilities

 

 

260

 

 

 

-

 

 

 

(50

)

 

 

238

 

Net cash used in operations

 

 

(9,370

)

 

 

(8,541

)

 

 

(15,654

)

 

 

(13,129

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of marketable securities

 

 

(25,525

)

 

 

-

 

 

 

(59,408

)

 

 

(49,550

)

Maturity of marketable securities

 

 

3,000

 

 

 

-

 

Maturities of marketable securities

 

 

43,669

 

 

 

-

 

Cash paid for property and equipment

 

 

(64

)

 

 

(326

)

 

 

(382

)

 

 

(490

)

Cash paid for patent filing fees

 

 

(12

)

 

 

(36

)

 

 

(53

)

 

 

(142

)

Net cash used in investing activities

 

 

(22,601

)

 

 

(362

)

 

 

(16,174

)

 

 

(50,182

)

Cash flow from financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from direct placement of common stock

 

 

-

 

 

 

69,106

 

 

 

-

 

 

 

69,106

 

Issuance cost associated with direct placement

 

 

-

 

 

 

(5,109

)

 

 

-

 

 

 

(5,109

)

Principal repayment of finance lease

 

 

-

 

 

 

(2

)

Proceeds from exercise of stock options

 

 

1

 

 

 

31

 

 

 

1

 

 

 

66

 

Net cash provided by financing activities

 

 

1

 

 

 

64,028

 

 

 

1

 

 

 

64,061

 

Effect of foreign exchange rate on cash and restricted cash

 

 

(6

)

 

 

(11

)

 

 

(70

)

 

 

(31

)

Net decrease in cash and cash equivalents and restricted cash

 

 

(31,976

)

 

 

55,114

 

Net increase/(decrease) in cash and cash equivalents and restricted cash

 

 

(31,897

)

 

 

719

 

Cash and cash equivalents and restricted cash beginning of the period

 

 

55,712

 

 

 

59,966

 

 

 

55,712

 

 

 

59,966

 

Cash and cash equivalents and restricted cash end of the period

 

$

23,736

 

 

$

115,080

 

 

$

23,815

 

 

$

60,685

 

Supplemental Disclosure of Cash Flow Information

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash paid for income taxes

 

$

17

 

 

$

28

 

Cash paid for interest

 

$

-

 

 

$

3

 

 

$

10

 

 

$

20

 

Plant and equipment purchases not yet paid

 

$

8

 

 

$

27

 

 

$

7

 

 

$

-

 

 

The accompanying notes form part of the unaudited consolidated financial statements.


AVITA MEDICAL, INC.

Notes to Consolidated Financial Statements

(Unaudited)

1. The Company

Nature of the Business

The AVITA group of companies (comprising AVITA Medical, Inc. (“AVITA”AVITA or the “Company”Company) and its subsidiaries, including AVITA Medical Pty Limited, previously known as AVITA Medical Limited (“AVITA Medical”Medical)) (collectively, “AVITA Group” or “we”, “us”, or “our”), is a commercial-stage regenerative medicine company focused onleading the treatmentdevelopment and commercialization of burns, traumadevices and other acute injuries, together withautologous cellular therapies for skin defects like vitiligo.restoration. The Company’s lead product is the RECELL® System technology platform harnesses the regenerative properties of a device that enables healthcare professionalspatient’s own skin to produce a suspension ofcreate Spray-On Skin™ Cells using a small sample of the patient’s own skin.cells. In September 2018, the United States Food & Drug Administration (“FDA”FDA) granted premarket approval (“PMA”PMA) to the RECELL System for use in the treatment of acute partial-thickness thermal burns in patients eighteen years and older. Following receipt of our original PMA, we commenced commercializingcommercialization of the RECELL System in January 2019 in the United States. In June 2021, the FDA approved an expanded indication to include treatmentuse of pediatricthe RECELL System in combination of meshed autografting for acute full-thickness thermal burns.wounds in pediatric and adult patients. In February 2022, the FDA approved a PMA supplement for the RECELL®RECELL Autologous Cell Harvesting Device with , an enhanced ease-of-use device aimed at providing clinicians a more efficient user experience and simplified workflow. In addition, the FDA has granted the Company Investigational Device Exemptions (“IDEs”IDEs), which have enabled the Company to initiate pivotal clinical trials to further expand the approvalindications of the RECELL System for the treatment of soft tissue reconstructionrepair and vitiligo. Enrollment of those clinical trials is complete, with topline results recently announced for both the soft tissue repair and if successful,vitiligo trials. Results from those studies would enableare intended to support the Company to seekCompany’s pursuit of FDA approval to market the RECELL System in the United States infor those indications.

In February 2019, we entered into a collaboration with COSMOTEC, an M3 Group company, to market and distribute the RECELL System in Japan. We worked with COSMOTEC to advance our application for approval of the RECELL System in Japan pursuant to Japan’s Pharmaceuticals and Medical Devices Act (“PMDA”PMDA). In February 2022, COSMOTEC’s application for regulatory approval was approved by the PMDA initially with labelling for burns only. In September 2022, COSMOTEC plans to commercially launchlaunched RECELL in Japan following Japan’s Ministry of Health, Labour,Labor, and Welfare approval of reimbursement pricing. Once data from the soft tissue repair and vitiligo datatrials are available from the Company’s related U.S. clinical trials, COSMOTEC plans to submit a further application for soft tissue repair and vitiligo indications.

In March 2020, the World Health Organization declared the outbreak of a novel strain of the coronavirus (“COVID-19”) a pandemic. We continue to closely monitor the recent developmentsimpact surrounding the continued spread and potential resurgence of COVID-19 due to existing and future variants. As a result of the pandemic, our customers (primarily hospitals) are experiencing disruptionsdate of this filing, with respect to a shortagethe continued overall decrease in operating room personnel.  Although the number of U.S.COVID-19 infections and hospitalizations due to COVID-19 has decreased in the last several months and many government imposed restrictions havehaving been lifted, we continue to be unable to predict the full impact that the ongoing COVID-19 pandemic will have on our future results of operations, liquidity, and financial condition due to numerous uncertainties, including the duration of the pandemic and the actions that may be taken in the future by government authorities across the United States in response to new variants. The Company has assessed the potential impact of COVID-19 on certain accounting matters including, but not limited to, the allowance for doubtful accounts, inventory reserves and return reserves, and impairment considerations for long-lived assets, marketable securities and intangibles, as of March 31,September 30, 2022, and through the date of this report. With respect to future operating results, it is not possible at this time to predict, with any degree of precision, the effects of COVID-19. Consequently, actual results for accounting estimates and assumptions, particularly those relating to the recoverability of certain intangible assets and estimates of expected credit losses on accounts receivable could differ from these estimates. However, we do not currently believe that COVID-19 will result in any significant changes in costs going forward. We will continue to monitor the performance of our business and reassess the impacts of COVID-19 and its variants.

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 of America (“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. 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 Transition Report on Form 10-KT for the transition period ended December 31, 2021 filed with the SEC on February 28, 2022 (United States) and the Australian Securities Exchange ("ASX") on March 01, 2022 (Australia) (the “Transition Report”).


There have been no changes to the Company’s significant accounting policies as described in the Transition Report on Form 10-KT 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 Transition 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.

Reclassification of Prior Year Presentation

Certain prior year amounts within other long-term assets and other long-term liabilities have been reclassified to Corporate-owned life insurance asset and Non-qualified deferred compensation plan liability, respectively, in the Consolidated Balance Sheets, for consistency with current period presentation. These reclassifications had no effect on consolidation.the reported results of operations or financial position. 

 

Use of Estimates

 

The preparation of the accompanying consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts (including doubtful accounts, carrying value of long-lived asset,assets, the useful lives of long-lived assets, accounting for marketable securities, income taxes, stock-basedshare-based compensation, and the stand-alone selling price for the BARDA contract) and related disclosures. Estimates have been prepared on the basis of 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 gain (loss) in shareholders’ equity. Gains and losses resulting from foreign currency transactions are included in general and administrative expenses and were a loss of $22,000 and gain of $8,000$76,000 and $41,000 for the three monthsthree-months ended March 31,September 30, 2022 and 2021, respectively. Foreign currency transactions were a gain of $123,000 and $58,000 for the nine-months ended September 30, 2022 and 2021, respectively.

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 and foreign currency transactions are included in general and administrative expenses.  During the three monthsthree-months ended March 31,September 30, 2022 and 2021, the Company recorded gains of $6,000 and a loss of $14,000, respectively. The Company recorded losses of $15,000$2,000 and $16,000,$30,000 for the nine-months ended September 30, 2022 and 2021, respectively.

Comprehensive Income (Loss)Loss

The components of comprehensive income (loss)loss consist of net income (loss),loss, foreign currency translation adjustments from its subsidiaries not using the U.S. dollar as their functional currency and unrealized gains and losses in investments available for sale. The Company did not have reclassifications from other comprehensive income (loss)loss to net loss during the quarterthree and nine-months ended March 31,September 30, 2022.

Revenue Recognition

 

The Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods or services.

 

To determine revenue recognition for arrangements that are within the scope of Accounting Standard Codification (“ASC”) Topic 606, Revenue Recognition, the Company performs the following five steps:

 

1.

Identify the contract with a customer

2.

Identify the performance obligations

3.

Determine the transaction price


4.

Allocate the transaction price to the performance obligations

5.

Recognize revenue when/as performance obligation(s) are satisfied

 

In order for an arrangement to be considered a contract, it must be probable that the Company will collect the consideration to which it is entitled for goods or services to be transferred. Once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised with each contract, determines whether those are performance obligations and the related transaction price. The Company then recognizes the sale of goods based on the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied.

 


The Company’s revenue consists primarily of the sale of the RECELL System to hospitals or other treatment centers and to BARDA (collectively, “customers”), predominately in the United States. The Company evaluated the BARDA contract and concluded that a portion of the arrangement, such as the procurement of the RECELL system and the emergency preparedness, represents a transaction with a customer and as such are in the scope of ASC 606.  Amounts received from BARDA for the research and development of the Company’s product are classified as BARDA income in the consolidated statementConsolidated Statements of operationsOperations and are accounted for under IAS 20.  For further details refer to BARDA Income and Receivables below.

 

Revenues for commercial customers (hospitals and treatment centers) are recognized as control of the product is transferred to customers, at an amount that reflects the consideration expected to be received in exchange for the product. Revenues are recognized net of volume discounts. As such, revenue is recognized only to the extent a significant reversal of revenues is not expected to occur in subsequent periods. For the Company’s contracts that have an original duration of one year or less, the Company elected the practical expedient applicable to such contracts and does not consider the time value of money. Further, because of the short duration of these contracts, the Company has not disclosed the transaction price for the remaining performance obligations as of each reporting period or when the Company expects to recognize this revenue. The Company has further applied the practical expedient to exclude sales tax in the transaction price and expense contract fulfilment costs such as commissions and shipping and handling expenses as incurred.

 

For revenues related to the BARDA contract within the scope of ASC 606, the Company identified 2two performance obligationsobligations: (i) the procurement of 5,614 RECELL units,units; and (ii) emergency preparedness services. Through this contract the Company promises to procure the product through a vendor management inventory arrangement and to stand ready to provide emergency deployment services related to the product. Emergency preparedness services include procuring necessary storage containers, housing, and maintaining the containers (and product), and providing shipping and handling services in the event of an emergency situation. This stand ready obligation is a series of distinct services that are substantially the same and have the same pattern of transfer to the customer, overtime as services are consumed.  

 

The total transaction price for the portion of the BARDA contract that is within the scope of ASC 606, was determined to be $9.2 million.  The transaction price was allocated on a stand-alone selling price basis as follows: $7.6 million to the procurement of the RECELL product, which is classified as revenuesRevenues when recognized in the consolidated statementConsolidated Statements of operationsOperations and $1.6 million to the emergency deployment services which is classified as revenuesRevenues when recognized in the consolidated statementConsolidated Statements of operations.Operations.  The $1.6 million for emergency deployment includes variable consideration which is deemed immaterial to the contract as a whole.  The Company estimated the stand-alone selling price of the procurement of the RECELL product based on historical pricing of the Company’s product at the initial execution of the contract. The Company estimated the stand-alone selling price of the emergency deployment services performed based on the Company’s projected cost of providing the services plus an applicable profit margin as denoted in the contract.

 

The Company’s performance obligations are either satisfied at a point in time or over time as services are provided. The product procurement performance obligation is satisfied at a point in time, upon transfer of control of the product. As such, the related revenue for these performance obligations is recognized at a point in time as revenue within the Company’s consolidated statementConsolidated Statement of operations.Operations. In addition to guidance under ASC 606, the Company recognizes revenue from the sales of RECELL product to BARDA for placement into vaccine stockpiles in accordance with SEC InterpretationSecurities and Exchange Commission (SEC) Interpretation,, Commission Guidance regarding Accounting for Sale of Vaccines and BioTerror Countermeasures to the Federal Government for Placement into the Pediatric Vaccine Stockpile or the Strategic National Stockpile (SNS). Under this guidance, revenue is recognized when product is placed in the BARDA vendor-managed inventory as control of the product has been transferred to the customer at the time of delivery to the VMI.  RECELL units that have been delivered to BARDA have a product replacement obligation at no cost to BARDA due to the product’s limited shelf-life. The estimated cost of the expired inventory over the term of the contract is recognized on a per unit basis at the time of delivery. The liability is released upon replacement of the product along with a corresponding reduction to inventory. The Company has estimated deferred cost of approximately $52,000 and $64,000 as of September 30, 2022 and December 31, 2021, respectively, for the rotation cost of the product. Such amounts are recorded in other current liabilities and other long-term liabilities as of September 30, 2022, and December 31, 2021, respectively. The emergency preparedness services performance obligation is satisfied over time.  Revenue for the emergency deployment will be recognized on a straight-line basis during the term of the contract as services are consumed over time. Services recognized are included in sales within the consolidated statementstatements of operations. Contract costs to fulfil the performance obligations are incremental and expected to be recovered are capitalized and amortized on a straight-line basis over the term of the contract. Contract costs are included in otherOther long-term assets.assets in the Consolidated Balance Sheets.


Contract Liabilities

The Company receives payments from customers based on contractual terms. Trade receivables are recorded when the right to consideration becomes unconditional. The Company satisfies its performance obligation on product sales when the products are shipped or delivered, depending on the terms of the sale. Payment terms on invoiced amounts are typically 30-90 days, and do not include a financing component.  Contract liabilities are recorded when the Company receives payment prior to satisfying its obligation to transfer goods to a customer.


 

Cost of Sales

 

Cost of sales related to products includes costs to manufacture or purchase, package, and ship the Company’s products. Costs also include relevant production overhead and depreciation and amortization. These costs are recognized when control of the product is transferred to the customer and revenue is recognized.

 

Income Taxes

 

Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income or loss in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that a portion of the deferred tax asset will not be realized. We recognize interest and penalties related to unrecognized tax benefits on the income tax expense line in the accompanying consolidated statement of operations. Accrued interest and penalties are included on the related tax liability line in the consolidated balance sheet.Consolidated Balance Sheets.

 

The Company reviews its uncertain tax positions regularly. An uncertain tax position represents the Company’s expected treatment of a tax position taken in a filed return or planned to be taken in a future tax return or claim that has not been reflected in measuring income tax expense for financial reporting purposes. The Company recognizes the tax benefit from an uncertain tax position when it is more-likely-than-not that the position will be sustained upon examination on the basis of the technical merits or the statute of limitations for the relevant taxing authority to examine and challenge the tax position has expired.

Cash and Cash Equivalents

Consists of cash held at deposit institutions and cash equivalents.  Cash equivalents consist of short-term highly liquid investments with original maturities of three monthsthree-months or less from the date of purchase and consist primarily of money market funds. The Company holds cash at deposit institutions in the amount of $6.9$6.2 million and $4.4 million of which $760,000$296,000 and $203,000 is denominated in foreign currencies in foreign institutions as of March 31,September 30, 2022 and December 31, 2021, respectively. As of March 31,September 30, 2022 and December 31, 2021, the Company held cash equivalents in the amount of $16.6$17.4 million and $51.1 million, respectively.

Restricted Cash

Pursuant to a contractual agreement to maintain the business credit card, the Company must maintain restricted cash deposits which amounted to approximately $201,000$202,000 and $201,000 as of March 31,September 30, 2022 and December 31, 2021, respectively.

Concentrations

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, marketable securities, trade receivables, BARDA receivables and other receivables. As of March 31,September 30, 2022 and December 31, 2021, substantially all of the Company’s cash was deposited in accounts at financial institutions, and amounts may exceed federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial strength of the depository institutions in which its cash is held.

As of March 31,September 30, 2022, no single commercial customer accounted for more than 10% of total revenues or net accounts receivable. As of December 31, 2021, one commercial customer accounted for approximately 10% of net accounts receivable.For the three-months ended September 30, 2022 and 2021, no single customer accounted for more than 10% of revenues. For the nine-months ended September 30, 2022, one customer accounted for more than 10% of total revenue.  For the nine-months ended September 30, 2021, no single customer accounted for more than 10% of revenues. BARDA revenue for emergency deployment accounted for approximately 1% and 47%1% of total revenues for the three monthsthree-months ended March 31,September 30, 2022 and 2021, respectively. For the nine-months ended


September 30, 2022 and 2021, BARDA revenue for emergency deployment accounted for approximately 1% and 30% of total revenues, respectively. BARDA receivables for emergency preparedness services accounted for 1%2% and 3% of total BARDA receivables as of March 31,September 30, 2022 and December 31, 2021, respectively. See table below for breakdown of BARDA receivables (in thousands).

 

 

As of

March 31,

2022

 

 

As of

December 31,

2021

 

 

As of

September 30,

2022

 

 

As of

December 31,

2021

 

BARDA procurement and emergency preparedness services

 

$

8

 

 

$

9

 

 

$

15

 

 

$

9

 

BARDA expense reimbursements

 

 

674

 

 

 

299

 

 

 

777

 

 

 

299

 

Total BARDA receivables

 

$

682

 

 

$

308

 

 

$

792

 

 

$

308

 


Marketable Securities

We classify all highly liquid investments with original maturities of three months or less from the date of purchase as cash equivalents and all highly liquid investments with stated maturities of greater than three months as marketable securities. The Company classifies marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date, and as long-term when the investments have remaining contractual maturities of more than one year from the balance sheet date. Classification is determined at the time of purchase and re-evaluated each balance sheet date. Short-term marketable securities represent investment of cash available for current operations.  We account for our marketable securities as available-for-sale securities.  

All marketable securities, which consist of corporate debt securities, U.S government agency obligations, U.S treasury and commercial paper are denominated in the U.S. dollars, have been classified as “available for sale”, and are carried at fair value. Unrealized gains and losses, net of any related tax effects, are excluded from earnings and are included in other comprehensive income (loss) and reported as a separate component of stockholdersshareholders equity until realized. Realized gains and losses on marketable securities are included in other income in the accompanying Consolidated Statementsconsolidated statements of Operations.operations. The cost of any marketable securities sold is based on the specific identification method. The amortized cost of marketable securities is adjusted for amortization of premiums and accretion of discounts to maturity. Interest on marketable securities is included in other income. In accordance with the Company’s investment policy, management invests to diversify credit risk and only invests in securities with high credit quality, including U.S. government securities, and the maximum final maturity from the date of purchase is thirty-seven months.

If necessary, the Company will recognize an allowance for credit losses on available-for-sale debt securities on an individual basis, and will no longer consider other than-temporary impairment or immediately reduce the cost basis of the investment provided that it is more likely than not that the security will be held to recovery or maturity. Further, the Company will recognize any improvements in estimated credit losses on available-for-sale debt securities immediately in earnings and reduce the existing allowance for credit losses. The Company will disaggregate its available-for-sale debt securities into the following categories: commercial paper, corporate debt, government and agency securities, asset backed securities and money market funds. The Company’s corporate bonds are comprised of predominantly high-grade corporate bonds while its government and agency securities are U.S. treasury bonds, and U.S. agency bonds. The Company has analyzed both corporate bonds and government and agency securities and identified that both types of securities have similar risk characteristics in that they are traded infrequently and have contractual interest rates and maturity dates.

To evaluate for impairment, management reviews credit rating changes, securities trends, interest rate movements and unrealized loss at the security level of the Company’s available for sale debt securities. If any of these give rise to a potential credit concern, the Company performs a discounted cash flow analysis to determine the credit portion of the impairment. The discounted cash flow analysis will be performed either internally or through the assistance of a qualified third party. Once the credit component of the impairment is determined, the Company will record the impaired amount as an allowance to the available-for-sale debt securities balance and as a charge to other income in the accompanying Consolidated Statementsconsolidated statements of Operations,operations, not to exceed the amount of the unrealized loss. The Company assesses expected credit losses at the end of each reporting period and adjusts the allowance through other income.

BARDA Income and Receivables

The AVITA Group was awarded a Biomedical Advance Research and Development Authority (“BARDA”) contract in September 2015. The contract with BARDA expires December 31, 2023. Under this arrangement BARDA supported the Company’s research and development for the Company’s product, including the U.S. clinical regulatory program targeted towards PMA, ourthe Company's compassionate use program, clinical and health economics research. Currently, the BARDA contract is supporting the Company’s clinical trial in soft-tissue reconstruction.

Consideration received under the BARDA arrangement is earned and recognized under a cost-plus-fixed-fee arrangement in which the Company is reimbursed for direct costs incurred plus allowable indirect costs and a fixed-fee earned. Billings under the contracts are based on approved provisional indirect billing rates, which permit recovery of fringe benefits, general and administrative expenses and a fixed fee.


The Company has concluded that grants under the BARDA arrangement are not within the scope of ASC 606, as it does not meet the definition of a contract with a “customer.” The Company has further concluded that Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition also does not apply, as the Company is a business entity and the payments are with governmental agencies or units. With respect to the BARDA arrangement, we considered the guidance in IAS 20, Accounting for Government Grants and Disclosure of Government Assistance, by analogy. BARDA income and related receivables are recognized when there is reasonable assurance that the amount will be received, and all attaching conditions have been complied with. When the payment relates to an expense item, the amount received is recognized as income over the period when the expense was incurred.


Leases

The Company has operating leases for corporate office space, manufacturing and a warehouse facility.  The Company’s operating leases have remaining lease terms of one year to two years, some of which include options to renew the lease.  At contract inception, the Company determines whether the contract is a lease or contains a lease. A contract contains a lease if the Company is both able to identify an asset and can conclude it has the right to control the identified asset for a period of time. Leases with an initial term of twelve months or less are not recorded on the condensed consolidated balance sheet.Consolidated Balance Sheets.

Right of useRight-of-use (“ROU”) assets represent the Company’s right to control an underlying asset for the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an explicit rate, the Company used its incremental borrowing rate (“IBR”) based on the information available at the commencement date in determining the discount rate used to present value lease payments. In determining the IBR, the Company considered its credit rating and current market interest rates. The IBR used approximates the interest that the Company would be required to pay for a collateralized loan over a similar term. The Company’s leases typically do not include any residual value guarantees or asset retirement obligations.

The Company’s lease terms are only for periods in which it has enforceable rights. A lease is no longer enforceable when both the lessee and the lessor each have the right to terminate the lease without permission from the other party with no more than an insignificant penalty. The Company has options to renew some of these leases for three years after their expiration. The Company considers these options, which may be elected at the Company’s sole discretion, in determining the lease term on a lease-by-lease basis. Lease expense is recognized on a straight-line basis over the lease term and is primarily included in general and administrative expenses in the accompanying consolidated statements of operations.

The Company has lease agreements with lease and non-lease components, which are accounted for as a single lease component for all underlying asset classes. Some leases require variable payments for common area maintenance, property taxes, parking, insurance and other variable costs. The variable portion of lease payments is not included in operating lease assets or liabilities. Variable lease costs are expensed when incurred.

Share-based compensation

The Company records compensation expense for stock options based on the fair market value of the awards on the date of grant. The fair value of share-based compensation awards is amortized over the vesting period of the award. Compensation expense for performance-based awards is measuredevaluated based on the number of shares ultimately expected to vest, estimated at each reportinggrant date based on management’s expectations regarding the relevant performance criteria, if any. The Black-Scholes option pricing model and Monte Carlo Simulation were used to estimate the fair value of the time-based and performance-based options, respectively.  To estimate the grant date fair value of the performance vesting employee stock options, we utilized a Monte Carlo simulation-based approach to capture the holder’s expected post-vesting exercise behavior.  Specifically, we simulated the Company’s stock price from the valuation date to the maturity of the options on a daily basis using Geometric Brownian Motion, whereby the options are assumed to be early exercised if the simulated stock price exceeded a certain exercise threshold estimated based on empirical research.  Under ASU 2016-09, Compensation – Stock Compensation (“ASC 718”) Improvements to Employee Share-Based Payment Accounting, the Company elected to account for forfeitures as they occur.

The following assumptions were used in the valuation of stock options.

 

Expected volatility – determined using the average of the historical volatility using daily intervals over the expected term and the derived volatility using the longest term available of 12 months.

 

Expected dividends - based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future

 

Expected term – the expected term of the Company’s stock options for tenure only vesting has been determined utilizing the “simplified” method as described in the SEC’s Staff Accounting Bulletin No. 107 relating to share-based compensation. The simplified method was chosen because the Company has limited historical option exercise experience due to its short


operating history of awards granted, with the first plan wasbeing established in 2016 andwhich was primarily used for Executivesexecutive awards.  Further, the Company does not have sufficient history of exercises in the U.S. market given the AVITA Group's recent redomiciliation from Australia to the United States duringin 2020. The expectedinitial term input of options with a performance condition was set to the contractual term of 10 years.years for the modeling process, while the expected term within each simulation path was determined by the early exercise mechanism discussed above within the Monte Carlo simulation model.  

 

Risk-free interest rate – the risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for a period approximately equal to the expected term of the award.


Segment Reporting

 

Operating segments are defined as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company’s chief operating decision makerdecision-maker is its Chief Executive Officer. To date, the Company has viewed its operations and manages its business as 1one segment.  

 

Non-Qualified Deferred Compensation Plan Liability and Investments in Corporate-Owned Life Insurance Asset

 

The Company’s Deferred Compensation Plannon-qualified deferred compensation plan (the "DCPNQDC plan"), which became effective onin October 2021, allows highly compensated key employees to elect to defer a portion of their salary, bonus, commissions and RSU awards to later years. Management determined that the DCPcash deferrals under the NQDC plan shall be accounted for similarsimilarly to a defined benefit plan under ASC 715,Compensation – Retirement Benefits, and should follow accounting treatment that is similar to a cash balance plan. Management determined that the employee portion and employer portion of the deferred compensation should be recognized as a compensation expense with a corresponding credit to deferred compensation liability. The matching contribution will be accrued over the vesting period of two-yearstwo years with 25% vesting in the first year and 75% vesting in the second year.  Employees aged 55 or older immediately vest in employer matching contributions. The change in the liability between each reporting period is accounted for as compensation expense with a corresponding adjustment to deferred compensation liability.  Upon distribution, the Company will record the distribution as a decrease to compensation liability with a corresponding credit to cash.  The Company funds the DCPNQDC plan through a Corporate-Owned Life Insurance (COLI(“COLI”).  Per the ASC 325-30-25-1A,, Investments Other, COLI is recorded as an asset in other long-term assetson the Consolidated Balance Sheets as it does not meet the definition of a plan asset under ASC 715.  The Company invests in COLI policies relating to its deferred compensation plan.  Investments in COLI policies are recorded at their cash surrender values as of each balance sheet date. Changes in the cash surrender value during the period are recorded as a gain or loss in the statementstatements of operations in Other income.

Rabbi Trust

During April 2022, we established a rabbi trust for a select group of participants in which share awards granted under the 2020 Omnibus Incentive Plan (“2020 Plan”) and deferred under the NQDC plan may be deposited. In addition to the deferral of shares, the rabbi trust holds the assets in the COLI for the NQDC plan.  The rabbi trust is an irrevocable trust and no portion of the trust fund may be used for any purpose other income.than the delivery of those assets to the participants. The assets held in the rabbi trust are subject to the claims of our general creditors in the event of bankruptcy or insolvency. The value of the assets of the rabbi trust is consolidated into our financial statements.

The NQDC plan permits diversification of vested shares (common stock) into other equity securities subject to a six-month and one day holding period subsequent to vesting.  Per ASC 710-10-25-15, accounting for deferred common stock will be under plan type C or D.  Accounting will depend on whether or not the employee has diversified the common stock. Under Plan type C, diversification is permitted but the employee has not diversified.  Under Plan type D, diversification is permitted and the employee has diversified.  

For common stock that have not been diversified, the employer 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 non-qualified deferred compensation plan.  Common stock will be recorded at fair value of the stock at the time it vested, subsequent changes in the value of the common stock will not be recognized. The deferred compensation obligation is measured independently at fair value of the common stock with a corresponding charge or credit to compensation cost. Fair value is determined as the product of the common stock and the closing price of the stock each reporting period.

Under plan type D, assets held by the rabbi trust are subject to applicable GAAP.  As diversified common stock will be invested in mutual funds, assets held by the rabbi trust will be subject to accounting in ASC 321 - Investments - Equity Securities. The deferred compensation obligation is measured independently at fair value of the underlying assets. As of September 30, 2022, deferred common stock has not been diversified.


Non-qualified deferred compensation share awards

In accordance with ASC 718, Compensation — Stock Compensation, the deferred RSU awards under the NQDC plan are classified as an equity instrument and changes in fair value of the amount owed to the participant are not recognized.  As the plan permits diversification, presentation outside of permanent equity in accordance with ASR 268, Redeemable Preferred Stock is appropriate. The redemption amounts are based on the vested percentage and are recorded outside of equity as non-qualified deferred compensation share awards on the Consolidated Balance Sheets. Deferred awards will be presented outside of permanent equity until the awards are vested.  

As of September 30, 2022, a total of 253,048 shares awards have been deferred with a redemption value of$272,000 and are recorded outside of equity as Non-qualified deferred compensation share awards. During the three-months ended September 30, 2022, 2022, 17,927 shares vested and were contributed to the rabbi trust at the vested value of $127,000. For further details refer to Note 18.

3. Accounting Standards Update

Recently Adopted Accounting Pronouncements

In November 2021, the FASB issued ASU 2021-10, “Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance.” ASC 832 requires business entities to provide certain disclosures when they (1) have received government assistance and (2) use a grant or contribution accounting model by analogy to other accounting guidance. The guidance will require business entities to disclose the nature of the transactions, accounting policies used to account for the transactions, and state which line items on the balance sheet and income statement are affected by these transactions and the amount applicable to each financial statement line. Business entities will also have to disclose significant terms and conditions of transactions with a government such as the duration of the agreement, any commitments made by either side, provisions, and contingencies. The guidance in ASU 2021-10 is effective for all entities for fiscal years beginning after December 15, 2021. Entities may apply the provision either (1) prospectively to all transactions within the scope of ASC 832 that are reflected in the financial statements as of the adoption date and all new transactions entered into after the date of adoption or (2) retrospectively. The Company adopted this standard as of January 1, 2022. The adoption did not have a material impact on the Consolidated Financial Statementsconsolidated financial statements or disclosures.  

 

In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes, or ASU 2019-12, which includes amendments to simplify the accounting for income taxes by removing certain exceptions to the general principles in ASC 740, Income Taxes, or ASC 740. The amendments also improve consistent application of and simplify U.S. GAAP for other areas of ASC 740 by clarifying and amending existing guidance. The new guidance is effective for the Company for annual periods beginning after December 15, 2021 and interim periods within fiscal years beginning after December 15, 2022. Early adoption of the amendments is permitted. The Company adopted this standard as of January 1, 2022. The adoption did not have a material impact on the Consolidated Financial Statements.consolidated financial statements.

 


 

Recent Accounting Pronouncements Not Yet Adopted

All other newly issued but not yet effective accounting pronouncements have been deemed to be not applicable or immaterial to the Company.

4. Marketable Securities

The following table summarizes the amortized cost and estimatesestimated fair values of debt securities available for sale:

 

 

March 31, 2022

 

 

As of September 30, 2022

 

 

Amortized

Cost

 

 

Gross

Unrealized

Holding

Gains

 

 

Gross

Unrealized

Holding

Losses

 

 

Carrying

Value

 

 

Amortized

Cost

 

 

Gross

Unrealized

Holding

Gains

 

 

Gross

Unrealized

Holding

Losses

 

 

Carrying

Value

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash Equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

16,617

 

 

$

-

 

 

$

-

 

 

$

16,617

 

 

$

17,425

 

 

$

-

 

 

$

-

 

 

$

17,425

 

Current marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S Treasury securities

 

$

27,246

 

 

$

1

 

 

$

(114

)

 

$

27,133

 

 

$

44,875

 

 

$

1

 

 

$

(539

)

 

$

44,337

 

Commercial paper

 

 

21,331

 

 

 

-

 

 

 

-

 

 

 

21,331

 

 

 

11,055

 

 

 

-

 

 

 

-

 

 

 

11,055

 

Corporate debt securities

 

 

9,517

 

 

 

1

 

 

 

(43

)

 

 

9,475

 

 

 

3,317

 

 

 

-

 

 

 

(33

)

 

 

3,284

 

U.S Government Agency Obligations

 

 

1,906

 

 

 

-

 

 

 

(10

)

 

 

1,896

 

 

 

1,902

 

 

 

-

 

 

 

(19

)

 

 

1,883

 

Total current marketable securities

 

$

60,000

 

 

$

2

 

 

$

(167

)

 

$

59,835

 

 

$

61,149

 

 

$

1

 

 

$

(591

)

 

$

60,559

 

Long-term marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S Treasury securities

 

$

10,990

 

 

$

-

 

 

$

(234

)

 

$

10,756

 

 

$

2,887

 

 

$

-

 

 

$

(21

)

 

$

2,866

 

Corporate debt securities

 

 

931

 

 

 

-

 

 

 

(3

)

 

 

928

 

 

 

557

 

 

 

-

 

 

 

(12

)

 

 

545

 

Asset backed securities

 

 

604

 

 

 

-

 

 

 

(3

)

 

 

601

 

Total Long-term marketable securities

 

$

11,921

 

 

$

-

 

 

$

(237

)

 

$

11,684

 

 

$

4,048

 

 

$

-

 

 

$

(36

)

 

$

4,012

 

 

 

 

 

As of December 31, 2021

 

 

 

Amortized

Cost

 

 

Gross

Unrealized

Holding

Gains

 

 

Gross

Unrealized

Holding

Losses

 

 

Carrying

Value

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash Equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

51,112

 

 

$

-

 

 

$

-

 

 

$

51,112

 

Current marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

$

19,586

 

 

$

-

 

 

$

-

 

 

$

19,586

 

Corporate debt securities

 

 

7,068

 

 

 

-

 

 

 

(7

)

 

 

7,061

 

Asset-backed securities

 

 

3,002

 

 

 

-

 

 

 

-

 

 

 

3,002

 

Total current marketable securities

 

$

29,656

 

 

$

-

 

 

$

(7

)

 

$

29,649

 

Long-term marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S Treasury securities

 

$

18,043

 

 

$

-

 

 

$

(89

)

 

$

17,954

 

Corporate debt securities

 

 

1,746

 

 

 

-

 

 

 

(8

)

 

 

1,738

 

Total Long-term marketable securities

 

$

19,789

 

 

$

-

 

 

$

(97

)

 

$

19,692

 

 

 


 

The maturities of debt securities available for sale are summarized in the following table using contractual maturities. Actual maturities may differ from contractual maturities due to obligations that are called or prepaid.

 

 

As of March 31, 2022

 

 

As of December 31, 2021

 

 

As of September 30, 2022

 

 

As of December 31, 2021

 

 

Amortized

Cost

 

 

Carrying

Value

 

 

Amortized

Cost

 

 

Carrying

Value

 

 

Amortized

Cost

 

 

Carrying

Value

 

 

Amortized

Cost

 

 

Carrying

Value

 

Due in one year or less

 

 

60,000

 

 

 

59,835

 

 

$

29,656

 

 

$

29,649

 

 

$

61,149

 

 

$

60,559

 

 

$

29,656

 

 

$

29,649

 

Due after one year through three years

 

 

11,921

 

 

 

11,684

 

 

$

19,789

 

 

$

19,692

 

 

$

4,048

 

 

$

4,012

 

 

$

19,789

 

 

$

19,692

 

 

Gross unrealized gains and losses on the Company’s marketable securities were an unrealized gain of $2,000$1,000 and an unrealized loss of $404,000$627,000 as of March 31,September 30, 2022, which resulted in a net unrealized loss of $402,000. During the three months ended March 31, 2022, the Company did 0t recognize credit losses.$626,000. Gross unrealized gains and losses on the Company’s marketable securities were an unrealized gain of $0 and an unrealized loss of $104,000 as of December 31, 2021 which resulted in a net unrealized loss of $104,000. During the transition period endedAs of September 30, 2022, and December 31, 2021, the Company did 0tnot recognize credit losses.  The Company has accrued interest income of $123,000$146,000 and $72,000 as of March 31,September 30, 2022, and December 31, 2021, respectively, recorded in Prepaidsprepaids and Other Current Assets.other current assets.

5. Fair Value Measurements

The authoritative guidance on fair value measurements establishes a framework with respect to measuring assets and liabilities at fair value on a recurring basis and non-recurring basis. Under the framework, fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, as of the measurement date. The framework also establishes a three-tier hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use in valuing the asset or liability and are developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability and are developed based on the best information available in the circumstances. The hierarchy consists of the following three levels:

Level 1: Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity can access at the measurement date.

Level 2: Inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.

Level 3: Inputs are unobservable inputs for the asset or liability

The following tables present information about the Company’s financial assets measured at fair value on a recurring basis, based on the three-tier fair value hierarchy:

 

 

As of March 31, 2022

 

 

As of September 30, 2022

 

(in thousands)

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash Equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

16,617

 

 

$

-

 

 

$

-

 

 

$

16,617

 

 

$

17,425

 

 

$

-

 

 

$

-

 

 

$

17,425

 

Total cash equivalents

 

 

16,617

 

 

 

-

 

 

 

-

 

 

 

16,617

 

 

 

17,425

 

 

 

-

 

 

 

-

 

 

 

17,425

 

Short-term marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S Treasury securities

 

 

-

 

 

 

27,133

 

 

 

-

 

 

 

27,133

 

 

 

-

 

 

 

44,337

 

 

 

-

 

 

 

44,337

 

Commercial paper

 

 

-

 

 

 

21,331

 

 

 

-

 

 

 

21,331

 

 

 

-

 

 

 

11,055

 

 

 

-

 

 

 

11,055

 

Corporate debt securities

 

 

-

 

 

 

9,475

 

 

 

-

 

 

 

9,475

 

 

 

-

 

 

 

3,284

 

 

 

-

 

 

 

3,284

 

U.S Government Agency Obligations

 

 

-

 

 

 

1,896

 

 

 

-

 

 

 

1,896

 

 

 

-

 

 

 

1,883

 

 

 

-

 

 

 

1,883

 

Total short-term marketable securities

 

 

-

 

 

 

59,835

 

 

 

-

 

 

 

59,835

 

 

 

-

 

 

 

60,559

 

 

 

-

 

 

 

60,559

 

Long-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S Treasury securities

 

 

-

 

 

 

10,756

 

 

 

-

 

 

 

10,756

 

 

 

-

 

 

 

2,866

 

 

 

-

 

 

 

2,866

 

Corporate debt securities

 

 

-

 

 

 

928

 

 

 

-

 

 

 

928

 

 

 

-

 

 

 

545

 

 

 

-

 

 

 

545

 

Asset backed securities

 

 

-

 

 

601

 

 

 

-

 

 

 

601

 

Total long-term marketable securities

 

 

-

 

 

 

11,684

 

 

 

-

 

 

 

11,684

 

 

 

-

 

 

 

4,012

 

 

 

-

 

 

 

4,012

 

Total marketable securities and cash equivalents

 

$

16,617

 

 

$

71,519

 

 

$

-

 

 

$

88,136

 

 

$

17,425

 

 

$

64,571

 

 

$

-

 

 

$

81,996

 

 

 


 

 

As of December 31, 2021

 

 

As of December 31, 2021

 

(in thousands)

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash Equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

51,112

 

 

$

-

 

 

$

-

 

 

$

51,112

 

 

$

51,112

 

 

$

-

 

 

$

-

 

 

$

51,112

 

Total cash equivalents

 

 

51,112

 

 

 

-

 

 

 

-

 

 

 

51,112

 

 

 

51,112

 

 

 

-

 

 

 

-

 

 

 

51,112

 

Short-term marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Commercial paper

 

 

-

 

 

 

19,586

 

 

 

-

 

 

 

19,586

 

 

 

-

 

 

 

19,586

 

 

 

-

 

 

 

19,586

 

Corporate debt securities

 

 

-

 

 

 

7,061

 

 

 

-

 

 

 

7,061

 

Asset-backed securities

 

 

-

 

 

 

3,002

 

 

 

-

 

 

 

3,002

 

 

 

-

 

 

 

3,002

 

 

 

-

 

 

 

3,002

 

Corporate debt securities

 

 

-

 

 

 

7,061

 

 

 

-

 

 

 

7,061

 

Total short-term marketable securities

 

 

-

 

 

 

29,649

 

 

 

-

 

 

 

29,649

 

 

 

-

 

 

 

29,649

 

 

 

-

 

 

 

29,649

 

Long-term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S Treasury securities

 

 

-

 

 

 

17,954

 

 

 

-

 

 

 

17,954

 

 

 

-

 

 

 

17,954

 

 

 

-

 

 

 

17,954

 

Corporate debt securities

 

 

-

 

 

 

1,738

 

 

 

-

 

 

 

1,738

 

 

 

-

 

 

 

1,738

 

 

 

-

 

 

 

1,738

 

Total long-term marketable securities

 

 

-

 

 

 

19,692

 

 

 

-

 

 

 

19,692

 

 

 

-

 

 

 

19,692

 

 

 

-

 

 

 

19,692

 

Total marketable securities and cash equivalents

 

$

51,112

 

 

$

49,341

 

 

$

-

 

 

$

100,453

 

 

$

51,112

 

 

$

49,341

 

 

$

-

 

 

$

100,453

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The Company’s Level 1 assets include money market instruments and are valued based upon observable market prices. Level 2 assets consist of commercial paper, U.S Government agency obligations, corporate debt securities, asset backed securities and U.S Treasury securities. Level 2 securities are valued based upon observable inputs that include reported trades, broker/dealer quotes, bids and offers. As of March 31,September 30, 2022 and December 31, 2021, the Company had no investments that were measured using unobservable (Level 3) inputs. There were no transfers between fair value measurement levels during the quarter ended March 31,as of September 30, 2022 or the transition period ended December 31, 2021.

6. Leases

During August 2021, the Company remeasured the lease liability for an office lease due to a change in the lease term. As a result of the remeasurement of the lease liability, there was an increase of approximately $392,000 to the operating lease ROU assets and operating lease liabilities. There was no impact on earnings as a result of the modification.

The following table sets forth the Company’s operating lease expenses which are included in general and administrative expenses in the consolidated statements of operations (in thousands):

 

 

Three months ended

March 31,

 

 

Three-months ended

September 30,

 

 

Nine-months ended

September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating lease cost

 

$

194

 

 

$

186

 

 

$

194

 

 

$

188

 

 

$

582

 

 

$

560

 

Variable lease cost

 

 

13

 

 

 

12

 

 

 

13

 

 

 

12

 

 

 

38

 

 

 

36

 

Total lease cost

 

$

207

 

 

$

198

 

 

$

207

 

 

$

200

 

 

$

620

 

 

$

596

 

 

 

Supplemental cash flow information related to operating leases for the three monthsand nine-months ended March 31,September 30, 2022 and 2021 was as follows (in thousands):

 

 

Three months ended

March 31,

 

 

Three-months ended

September 30,

 

 

Nine-months ended

September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Cash paid for amounts included in the measurement of lease

liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating cash outflows from operating leases

 

$

198

 

 

$

191

 

 

$

201

 

 

$

192

 

 

$

598

 

 

$

575

 

 

 


 

Supplemental balance sheet information, as of March 31,September 30, 2022 and December 31, 2021 related to operating leases was as follows (in thousands):

 

 

As of

March 31,

2022

 

 

As of

December 31,

2021

 

 

As of

September 30,

2022

 

 

As of

December 31,

2021

 

Reported as:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease right-of-use assets

 

$

1,375

 

 

$

1,544

 

 

$

1,029

 

 

$

1,544

 

Total right-of-use assets

 

$

1,375

 

 

$

1,544

 

 

$

1,029

 

 

$

1,544

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other current liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease liabilities, short-term

 

$

738

 

 

$

720

 

 

$

702

 

 

$

720

 

Operating lease liabilities, long term

 

 

726

 

 

 

918

 

 

 

405

 

 

 

918

 

Total operating lease liabilities

 

$

1,464

 

 

$

1,638

 

 

$

1,107

 

 

$

1,638

 

Operating lease weighted average remaining lease term

(years)

 

 

2.07

 

 

 

2.30

 

 

 

1.64

 

 

 

2.30

 

Operating lease weighted average discount rate

 

 

6.54

%

 

 

6.51

%

 

 

6.64

%

 

 

6.51

%

 

 

As of March 31,September 30, 2022, maturities of the Company’s operating lease liabilities are as follows (in thousands):

 

 

 

 

Operating Leases

 

 

 

 

Operating Leases

 

2022

 

 

 

$

604

 

Remainder of 2022

 

 

 

$

205

 

2023

 

 

 

 

649

 

 

 

 

 

649

 

2024

 

 

 

 

313

 

 

 

 

 

314

 

2025

 

 

 

 

-

 

Total lease payments

 

 

 

 

1,566

 

 

 

 

 

1,168

 

Less imputed interest

 

 

 

 

(102

)

 

 

 

 

(61

)

Total operating lease liabilities

 

 

 

$

1,464

 

 

 

 

$

1,107

 

 

As of March 31,September 30, 2022, there were no leases entered into that had not yet commenced.

 

7. Inventory

The composition of inventory is as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

 

 

As of

March 31,

2022

 

 

As of

December 31,

2021

 

 

As of

September 30,

2022

 

 

As of

December 31,

2021

 

Raw materials

 

$

1,256

 

 

$

1,222

 

 

$

1,384

 

 

$

1,222

 

Work in process

 

 

439

 

 

 

176

 

 

 

209

 

 

 

176

 

Finished goods

 

 

108

 

 

 

734

 

 

 

367

 

 

 

734

 

Total inventory

 

$

1,803

 

 

$

2,132

 

 

$

1,960

 

 

$

2,132

 

 

The Company has reduced the carrying value of its inventories to reflect the lower of cost or net realizable value. Charges for estimated excess and obsolescence are recorded in cost of sales in the consolidated statementstatements of operations and were $97,000$125,000 and $243,000,$46,000, for each of the three monthsthree-months ended March 31,September 30, 2022 and March 31,2021, respectively. Charges for estimated excess and obsolescence were $284,000 and $288,000 for the nine-months ended September 30, 2022 and 2021, respectively.


8. Intangible Assets

The composition of intangible assets, net is as follows (in thousands):

 


 

 

 

 

 

As of March 31, 2022

 

 

As of December 31, 2021

 

 

 

 

 

 

As of September 30, 2022

 

 

As of December 31, 2021

 

 

Weighted

Average Life

 

 

Gross

Amount

 

 

Accumulated

Amortization

 

 

Net

Carry

Amount

 

 

Gross

Amount

 

 

Accumulated

Amortization

 

 

Net

Carry

Amount

 

 

Weighted

Average Life

 

 

Gross

Amount

 

 

Accumulated

Amortization

 

 

Net

Carry

Amount

 

 

Gross

Amount

 

 

Accumulated

Amortization

 

 

Net

Carry

Amount

 

Patent 1

 

 

2

 

 

$

211

 

 

$

(210

)

 

$

1

 

 

$

209

 

 

$

(182

)

 

$

27

 

 

 

2

 

 

$

211

 

 

$

(210

)

 

$

1

 

 

$

209

 

 

$

(182

)

 

$

27

 

Patent 2

 

 

11

 

 

 

128

 

 

 

(19

)

 

 

109

 

 

 

123

 

 

 

(18

)

 

 

105

 

 

 

13

 

 

 

137

 

 

 

(25

)

 

 

112

 

 

 

123

 

 

 

(18

)

 

 

105

 

Patent 3

 

 

14

 

 

 

192

 

 

 

(28

)

 

 

164

 

 

 

192

 

 

 

(25

)

 

 

167

 

 

 

14

 

 

 

192

 

 

 

(37

)

 

 

155

 

 

 

192

 

 

 

(25

)

 

 

167

 

Patent 5

 

 

20

 

 

 

46

 

 

 

(4

)

 

 

42

 

 

 

46

 

 

 

(3

)

 

 

43

 

 

 

19

 

 

 

71

 

 

 

(5

)

 

 

66

 

 

 

46

 

 

 

(3

)

 

 

43

 

Patent 6

 

 

20

 

 

 

39

 

 

 

(3

)

 

 

36

 

 

 

39

 

 

 

(2

)

 

 

37

 

 

 

20

 

 

 

44

 

 

 

(3

)

 

 

41

 

 

 

39

 

 

 

(2

)

 

 

37

 

Patent 7

 

 

13

 

 

 

2

 

 

 

-

 

 

 

2

 

 

 

2

 

 

 

-

 

 

 

2

 

 

 

13

 

 

 

2

 

 

 

-

 

 

 

2

 

 

 

2

 

 

 

-

 

 

 

2

 

Patent 8

 

 

20

 

 

 

3

 

 

 

-

 

 

 

3

 

 

 

3

 

 

 

-

 

 

 

3

 

 

 

19

 

 

 

13

 

 

 

-

 

 

 

13

 

 

 

3

 

 

 

-

 

 

 

3

 

Patent 10

 

 

19

 

 

 

3

 

 

 

-

 

 

 

3

 

 

 

3

 

 

 

-

 

 

 

3

 

 

 

19

 

 

 

3

 

 

 

-

 

 

 

3

 

 

 

3

 

 

 

-

 

 

 

3

 

Patent 11

 

 

19

 

 

 

6

 

 

 

-

 

 

 

6

 

 

 

6

 

 

 

-

 

 

 

6

 

 

 

19

 

 

 

6

 

 

 

-

 

 

 

6

 

 

 

6

 

 

 

-

 

 

 

6

 

Trademarks

 

Indefinite

 

 

 

50

 

 

 

-

 

 

 

50

 

 

 

50

 

 

 

-

 

 

 

50

 

 

Indefinite

 

 

 

50

 

 

 

-

 

 

 

50

 

 

 

50

 

 

 

-

 

 

 

50

 

Total intangible assets

 

 

 

 

 

$

680

 

 

$

(264

)

 

$

416

 

 

$

673

 

 

$

(230

)

 

$

443

 

 

 

 

 

 

$

729

 

 

$

(280

)

 

$

449

 

 

$

673

 

 

$

(230

)

 

$

443

 

 

 During the three monthsand nine-months ended March 31,September 30, 2022, and 2021, the Company did not identify any events or changes in circumstances that indicated that the carrying value of its intangibles may not be recoverable. As such, there was 0no impairment of intangibles assets recognized for the three monthsand nine-months ended March 31, 2022September 30, 2022. During the three and 2021.nine-months ended September 30, 2021, the Company recorded an impairment charge of $19,000 for an abandoned patent. Amortization expense of intangibles included in the consolidated statements of operations was $34,000$8,000 and $30,000$27,000 for the three monthsthree-months ended March 31,September 30, 2022 and 2021, respectively. Amortization expense of intangibles included in the consolidated statements of operations was $50,000 and $88,000 for the nine-months ended September 30, 2022 and 2021, respectively.

The Company expects the future amortization of amortizable intangible assets held at March 31,September 30, 2022 to be as follows (in thousands):

 

 

 

 

 

 

 

 

 

 

 

Estimated Amortization

Expense

 

 

 

 

 

 

 

 

 

 

 

Estimated Amortization

Expense

 

2023

 

 

 

 

 

 

 

 

 

 

 

 

30

 

 

 

 

 

 

 

 

 

 

 

 

$

33

 

2024

 

 

 

 

 

 

 

 

 

 

 

 

30

 

 

 

 

 

 

 

 

 

 

 

 

 

32

 

2025

 

 

 

 

 

 

 

 

 

 

 

 

30

 

 

 

 

 

 

 

 

 

 

 

 

 

32

 

2026

 

 

 

 

 

 

 

 

 

 

 

 

30

 

 

 

 

 

 

 

 

 

 

 

 

 

32

 

2027

 

 

 

 

 

 

 

 

 

 

 

 

30

 

 

 

 

 

 

 

 

 

 

 

 

 

32

 

Thereafter

 

 

 

 

 

 

 

 

 

 

 

 

216

 

 

 

 

 

 

 

 

 

 

 

 

 

238

 

Total

 

 

 

 

 

 

 

 

 

 

 

$

366

 

 

 

 

 

 

 

 

 

 

 

 

$

399

 

 


 

9. Plant and Equipment

The composition of property, plant and equipment, net is as follows (in thousands):

 

 

Useful Lives

 

As of

March 31,

2022

 

 

As of December 31, 2021

 

 

Useful Lives

 

As of

September 30, 2022

 

 

As of

December 31, 2021

 

Computer equipment

 

3 years

 

$

750

 

 

$

740

 

 

3 years

 

$

734

 

 

$

740

 

Computer software

 

3 years

 

 

811

 

 

 

811

 

 

3 years

 

 

871

 

 

 

811

 

Construction in progress

 

 

 

 

-

 

 

 

29

 

 

 

 

 

181

 

 

 

29

 

Furniture and fixtures

 

7 years

 

 

440

 

 

 

440

 

 

7 years

 

 

440

 

 

 

440

 

Laboratory equipment

 

5 years

 

 

623

 

 

 

566

 

 

5 years

 

 

643

 

 

 

566

 

Leasehold improvements

 

Lesser of life or lease term

 

 

242

 

 

 

242

 

 

Lesser of life or lease term

 

 

257

 

 

 

242

 

RECELL Moulds

 

5 years

 

 

129

 

 

 

129

 

 

5 years

 

 

129

 

 

 

129

 

Less: accumulated amortization and depreciation

 

 

 

 

(1,824

)

 

 

(1,695

)

 

 

 

 

(2,029

)

 

 

(1,695

)

Total plant and equipment, net

 

 

 

$

1,171

 

 

$

1,262

 

 

 

 

$

1,226

 

 

$

1,262

 

 

Depreciation expense related to plant and equipment for the three monthsthree-months ended March 31,September 30, 2022 and 2021 was $129,000$130,000 and $137,000,$147,000, respectively. Depreciation expense related to plant and equipment for the nine-months ended September 30, 2022 and 2021 was $388,000 and $429,000, respectively.

10. Prepaids and Other Current and Long-Term Assets and Other long-term assetsLiabilities

Prepaids and other current assets consisted of the following (in thousands):

 

As of

March 31,

2022

 

 

As of

December 31,

2021

 

 

As of

September 30, 2022

 

 

As of

December 31, 2021

 

Prepaid expenses

 

$

994

 

 

$

1,124

 

 

$

862

 

 

$

1,124

 

Lease deposits

 

 

2

 

 

 

2

 

 

 

16

 

 

 

2

 

Accrued investment income

 

 

123

 

 

 

72

 

 

 

146

 

 

 

72

 

Other receivables

 

 

27

 

 

 

15

 

 

 

17

 

 

 

15

 

Total prepaids and other current assets

 

$

1,146

 

 

$

1,213

 

 

$

1,041

 

 

$

1,213

 

 

Prepaid expenses primarily consist of prepaid benefits and insurance.

Other long-term assets consisted of the following (in thousands):

 

 

As of

March 31,

2022

 

 

As of

December 31,

2021

 

 

As of

September 30, 2022

 

 

As of

December 31, 2021

 

BARDA contract costs

 

$

441

 

 

$

504

 

 

$

315

 

 

$

504

 

Corporate-owned life insurance policies

 

 

586

 

 

 

304

 

Long-term lease deposits

 

 

124

 

 

 

124

 

 

 

121

 

 

 

124

 

Long-term prepaids

 

 

11

 

 

 

10

 

 

 

112

 

 

 

10

 

Total other long-term assets

 

$

1,162

 

 

$

942

 

 

$

548

 

 

$

638

 

Other current liabilities consisted of the following (in thousands):

 

 

As of

September 30, 2022

 

 

As of

December 31, 2021

 

Operating lease liability

 

$

702

 

 

$

720

 

Unsettled investment trade payable

 

 

480

 

 

 

-

 

Other current liabilities

 

 

437

 

 

 

355

 

Total other current liabilities

 

$

1,619

 

 

$

1,075

 

 

 

 

 

 

 

 

 

 

 


 

11. Reporting Segment and Geographic Information

The Company views its operations and manages its business in 1one reporting segment. Long-lived assets are primarily located in the United States as of March 31,September 30, 2022, and December 31, 2021 with an insignificant amount located in Australia and the United Kingdom.

  Revenue by region for the three monthsand nine-months ended March 31,September 30, 2022, and 2021 were as follows (in thousands):

 

 

Three months ended

March 31,

 

 

Three-months ended

September 30,

 

 

Nine-months ended

September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

$

7,398

 

 

$

8,725

 

 

$

8,996

 

 

$

6,924

 

 

$

24,672

 

 

$

25,888

 

Foreign:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Australia

 

 

87

 

 

 

25

 

 

 

57

 

 

 

66

 

 

 

173

 

 

 

141

 

United Kingdom

 

 

54

 

 

 

15

 

 

 

39

 

 

 

30

 

 

 

121

 

 

 

60

 

Total

 

$

7,539

 

 

$

8,765

 

 

$

9,092

 

 

$

7,020

 

 

$

24,966

 

 

$

26,089

 

 

Revenue and Costcost of sales by Customercustomer type for the three monthsand nine-months ended March 31,September 30, 2022, and 2021 were as follows (in thousands):

 

 

Three months ended

March 31,

 

 

Three-months ended

September 30,

 

 

Nine-months ended

September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Commercial sales

 

$

7,446

 

 

$

4,622

 

 

$

8,999

 

 

$

6,928

 

 

$

24,687

 

 

$

18,249

 

BARDA:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

 

-

 

 

 

4,085

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

7,594

 

Services for emergency preparedness

 

 

93

 

 

 

58

 

 

 

93

 

 

 

92

 

 

 

279

 

 

 

246

 

Total

 

$

7,539

 

 

$

8,765

 

 

$

9,092

 

 

$

7,020

 

 

$

24,966

 

 

$

26,089

 

 

 

 

Three-months ended

September 30,

 

 

Nine-months ended

September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Cost of sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Commercial cost

 

$

1,446

 

 

$

1,006

 

 

$

4,453

 

 

$

3,187

 

BARDA:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product cost

 

 

-

 

 

 

-

 

 

 

(12

)

 

 

1,889

 

Emergency preparedness service cost

 

 

84

 

 

 

82

 

 

 

253

 

 

 

211

 

Total

 

$

1,530

 

 

$

1,088

 

 

$

4,694

 

 

$

5,287

 

 

 

 

Three months ended

March 31,

 

 

 

2022

 

 

2021

 

Cost of sales

 

 

 

 

 

 

 

 

Commercial cost

 

$

1,705

 

 

$

966

 

BARDA:

 

 

 

 

 

 

 

 

Product cost

 

 

(12

)

 

 

1,130

 

Emergency preparedness service cost

 

 

85

 

 

 

50

 

Total

 

$

1,778

 

 

$

2,146

 

 

12. Contingencies

The Company is subject to certain contingencies arising in the ordinary course of business. The Company records accruals for these contingencies to the extent that a loss is both probable and reasonably estimable. If some amount within a range of loss appears to be a better estimate than any other amount within the range, that amount is accrued. Alternatively, when no amount within a range of loss appears to be a better estimate than any other amount, the lowest amount in the range is accrued. The Company expenses legal costs associated with loss contingencies as incurred. As of March 31,September 30, 2022 and December 31, 2021, the Company did 0tnot have any outstanding or threatened litigation that would have a material impact to the financial statements.


13. Common and Preferred Stock

The Company’s CHESS Depositary Interests ("CDIs"(“CDIs”) are quoted on the ASX under the ticker code, “AVH”. The Company’s shares of common stock are quoted on NASDAQthe Nasdaq Capital Market (“Nasdaq”) under the ticker code, “RCEL”.  One share of common stock on NASDAQ is equivalent to five CDIs on the ASX.

 


As a result of the ‘implicit consolidation’ that occurred under the AVITA group'sgroup’s redomiciliation from Australia to the United States of America in 2020 (the “Redomiciliation”), the number of shares of common stock on issue in the Company (as set out in the consolidated financial statements) is less than the number of ordinary shares in AVITA Medical (the prior parent company of the AVITA group) that was previously set out in the consolidated financial statements of AVITA Medical. All common share amounts included in the consolidated financial statements have been retroactively reduced by a factor of one hundred and all per share amounts have been increased by a factor or one hundred, with the exception of the Company’s common stock par value.

 

The Company is authorized to issue 200,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share, issuable in one or more series as designated by the Company’s board of directors. No other class of capital stock is authorized. As of March 31,September 30, 2022, and December 31, 2021, 24,955,58125,030,902 and 24,925,743 shares of common stock, respectively, were issued and outstanding and 0no shares of preferred stock were outstanding.    

On March 1, 2021, the Company issued 3,214,250 shares of common stock at the offering price of $21.50 per share. The gross proceeds from the offering were approximately $69.1 million while the Company incurred $5.1 million in capital issuance expenses. The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-249419) that was previously filed with the Securities and Exchange Commission (the “SEC”) on October 9, 2020 and declared effective on October 16, 2020. It was also publicly released on the ASX. The final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on February 25, 2021 (in the United States) and released on the ASX on March 1, 2021 (in Australia).     

14. Revenues

Revenues

The Company’s revenue consists of sale of the RECELL System to hospitals or other treatment centers (“commercial customers”) and to BARDA (collectively “customers”), predominately in the United States. In addition, the Company records service revenue for the emergency preparedness services provided to BARDA.

 

Performance Obligations

For commercial contracts, we identified the hospital or treatment center as the customer in Step 1 of the 5-step model of ASC 606 and have determined a contract exists with those customers. As these contracts typically have a single performance obligation (i.e. product delivery), no allocation of the transaction price is required in Step 4 of the model. Control of the product is transferred to the customer at a point in time, at the point in time at which the goods are either shipped or delivered to our customers’ facilities, depending on the terms of the contract. The transaction price is stated within the contract and is therefore fixed consideration. The transaction price does not include the sales tax that areis imposed by governmental authorities.

 

For the contract with BARDA, the Company identified 2two performance obligations (i) the procurement of 5,614 RECELL units; and (ii) emergency preparedness services. The Company’s performance obligations are either satisfied at a point in time or over time as services are provided. The product procurement performance obligation is satisfied at a point in time, upon transfer of control of the product. RECELL units that have been delivered to BARDA have a product replacement obligation at 0no cost to BARDA due to the product’s limited shelf-life. The estimated cost of the expired inventory over the term of the contract is recognized on a per unit basis at the time of delivery.  The liability is released upon replacement of the product along with a corresponding reduction to inventory. The Company has estimated deferred cost of approximately $52,000 and $64,000 as of March 31,September 30, 2022 and December 31, 2021, respectively, for the rotation cost of the product.  Such amounts are recorded in other current liabilities and other long-term liabilities as of March 31,September 30, 2022, and December 31, 2021, respectively. The emergency preparedness services performance obligation is satisfied over time.  Revenue for the emergency deployment will be recognized on a straight-line basis during the term of the contract as services are consumed over time. Services recognized for the three monthsthree-months ended March 31,September 30, 2022 and 2021 were $93,000 and $58,000,$92,000, respectively, and are included in sales within the consolidated statementstatements of operations. Services recognized for the nine-months ended September 30, 2022 and 2021 were $279,000 and $246,000, respectively.  Contract costs to fulfil the performance obligation are incremental and expected to be recovered are capitalized and amortized on a straight-line basis over the term of the contract. As of March 31,September 30, 2022 and December 31, 2021 contract costs of $441,000$315,000 and $504,000 are included in other long-term assets, respectively.


 

Remaining Performance Obligations

Revenues from remaining performance obligations are calculated as the dollar value of the remaining performance obligations on executed contracts. The estimated revenue expected to be recognized in the future related to performance obligations that are unsatisfied (or partially unsatisfied) pursuant to the Company’s existing customer agreements is $882,000$740,000 and $952,000 as of March 31,September 30, 2022 and December 31, 2021, respectively.  Approximately $447,000$308,000 for March 31,September 30, 2022 and $517,000 for December 31, 2021 of the total balance relates to our July 2020 contract with BARDA for the purchase, delivery and storage of RECELL Systems for emergency response preparedness for a period of three years. The Company expects to recognize this amount as services are provided to BARDA. For the remaining balance of $432,000 and $435,000 as of March 31,September 30, 2022 and December 31, 2021, respectively, the Company expects to recognize revenue on a straight-line basis over the term of the contract uponcommencing with the generation of commercial sales for with Cosmotec. For the contract with BARDA, we recognized $93,000 and $58,000 of service revenue related to the emergency readiness performance obligation during the three months ended March 31, 2022 and 2021. COSMOTEC.We are contracted to manage this inventory of product until the federal government requests shipment or at contract termination on December 31, 2023.


 

Variable Consideration

The Company evaluates its contracts with customers for forms of variable consideration, which may require an adjustment to the transaction price based on their estimated impact. For commercial customers, revenue from the sale of goods is recognized net of volume discounts. The Company uses the expected value method when estimating variable consideration. Revenue is only recognized to the extent that it is probable that a significant reversal will not occur.  Variable consideration under the BARDA contract is not material to the consolidated financial statements.

 

Contract Assets and Contract Liabilities

Contract assets include amounts related to the Company’s contractual right to consideration for both completed and partially completed performance for which the Company does not have the right to payment. As of the period ended March 31,September 30, 2022 and December 31, 2021, the Company does 0tnot have any contract assets.

Contract liabilities are recorded when the Company receives payment prior to satisfying its obligation to transfer goods to a customer. The Company had $882,000$740,000 and $952,000 of contract liabilities as of March 31,September 30, 2022 and December 31, 2021, respectively. The balance relaterelates to the unsatisfied performance obligation for emergency preparedness under the BARDA contract and Cosmotec.  PerformanceCOSMOTEC.  The performance obligation will be satisfied, and revenue will be recognized over time over the term of the contract.  For the three monthsthree-months ended March 31,September 30, 2022 and 2021, the Company recognized $93,000 and $58,000$92,000 of revenue from BARDA and $3,000 and $0 for COSMOTEC of the amounts included in the beginning balance of contract liabilities. For the nine-months ended September 30, 2022, and 2021, the Company recognized $279,000 and $246,000 of revenue from BARDA and $3,000 and $0 for COSMOTEC from amounts included in the beginning balance of contract liabilities.

 

Cost to Obtain and Fulfill a Contract

Commercial contract fulfillment costs include commissions and shipping expenses. The Company has opted to immediately expense the incremental cost of obtaining a contract when the underlying related asset would have been amortized over one year or less. The Company generally does not incur costs to obtain new contracts.

 

BARDA Contract Costs

Cost to fulfill the BARDA emergency preparedness performance obligation, which primarily consist of billed costs to BARDA incurred in connection with the emergency deployment services, are incremental and expected to be recovered.  Costs are capitalized and amortized on a straight-line basis over the term of the contract. As of March 31,September 30, 2022, and December 31, 2021, the Company had $441,000315,000 and $504,000 of contracts costs included in other long-term assets.  Amortization expense related to deferred contract costs were $85,000$84,000 and $50,000,$82,000, during the three monthsthree-months ended March 31,September 30, 2022, and 2021, respectively, and are classified as cost of sales on the accompanying consolidated Statementsstatements of Operations.operations. Amortization expense related to deferred contract costs were $253,000 and $211,000, during the nine-months ended September 30, 2022, and 2021, respectively. There was 0no impairment loss in relation to deferred contract costs during the three monthsthree-months ended March 31,September 30, 2022, and 2021, or the nine-months ended September 30, 2022 and 2021.

 

Disaggregated Revenue

The Company disaggregates revenue from contracts with customers into geographical regions and by customer type.  As noted in the segment footnote, the Company’s business consists of one reporting segment. A reconciliation of disaggregated revenue by geographical region and customer type is provided in Segment Note 11.


 

15. Share-Based Payment Plans

Overview of Employee Share-Based Compensation Plans

Our former parent company, AVITA Medical, adopted the Employee Share Plan and the Incentive Option Plan (collectively, the “2016 Plans”). Upon completion of the Redomiciliation, the 2016 Plans were terminated with respect to future grants and accordingly, there are no more shares available to be issued under the 2016 Plans.  In addition, upon completion of the Redomiciliation, the Company had an implicit consolidation or reverse stock split of 100:1 and all share information presented below in relation to the 2016 Plans has been presented on a reverse stock split stock basis. During November 2020, the Company, pursuant to Rule 416 under the Securities Act of 1933, filed a registration statement on formForm S-8 to register a total of 1,750,000 shares of common stock which may be issued pursuant to the terms of the Company’s 2020 Omnibus Incentive Plan (“2020 Plan”). On December 22, 2021, the Company’s stockholders approved the issuance of options and awards to the Board of Directors and the CEO.Company's former CEO ("Former CEO"). These awards are subject to the vesting and performance conditions as denoted in the individual agreements.

The 2020 Plan provides for the grant of the following Grants: (a) Incentive Stock Options, (b) Nonstatutory Stock Options, (c) Stock Appreciation Rights, (d) Restricted Stock Grants, (e) Restricted Stock Unit Grants, (f) Performance Grants, and (g) Other Grants.  The 2020 Plan will be administered by the Compensation Committee or by the Board acting as the Compensation Committee. Subject to the general purposes, terms and conditions of the 2020 Plan, applicable law and any charter adopted by the Board governing the actions of the Compensation Committee, the Compensation Committee will have full power to implement and carry out the 2020 Plan. Without limitation, the Compensation Committee will have the authority to interpret the plan, approve persons to


receive grants, determine the terms and number of shares of the grants, determine vesting and exercisability of grants, and make all other determinations necessary or advisable in connection with the administration of this Plan.

The contractual term of awards granted under the 2020 Plan is ten years from the date of its grant. Unless otherwise specified, the vesting period of awards granted under the 2020 Plan was: (i) vest over a four yearfour-year period in four equal installments, 25% at the end of each year from the date of grant, and /or (ii) subject to other performance criteria and hurdles, as determined by the Compensation Committee.

Share-Based Payment Expenses

Share-based payment transactions are recognized as compensation expense based on the fair value of the instrument on the date of grant.  The Company uses the graded-vesting method to recognize compensation expense.  Compensation cost is reduced for forfeitures as they occur in accordance with ASU 2016-09, Simplifyingsimplifying the Accounting for Share-Based PaymentsPayment ("ASU 2016-09"2016”09"). During the three monthsthree-months ended March 31,September 30, 2022, and 2021, the Company recorded share-based compensation expense of $2.9$1.4 million, and $1.3$1.8 million, respectively. NaNDuring the nine-months ended September 30, 2022, and 2021, the Company recorded share-based compensation expense of $5.8 million, and $4.6 million, respectively. No income tax benefit was recognized in the consolidated statementstatements of operations for share-based payment arrangements for the three monthsthree-months ended March 31,September 30, 2022, and 2021, or the nine-months ended September 30, 2022, and 2021.

The Company has included share-based compensation expense as part of operating expenses in the accompanying consolidated statements of operations as follows (in thousands):

 

Three-months ended March 31,

 

 

Three-months ended

September 30,

 

 

Nine-months ended

September 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Sales and marketing expenses

 

$

329

 

 

$

238

 

 

$

408

 

 

$

291

 

 

$

1,022

 

 

$

592

 

General and administrative expenses

 

 

2,327

 

 

 

930

 

 

 

761

 

 

 

1,251

 

 

 

4,071

 

 

 

3,353

 

Research and development expenses

 

 

276

 

 

 

165

 

 

 

267

 

 

 

300

 

 

 

689

 

 

 

640

 

Total

 

$

2,932

 

 

$

1,333

 

 

$

1,436

 

 

$

1,842

 

 

$

5,782

 

 

$

4,585

 


 

A summary of share option activity as of March 31,September 30, 2022, and changes during the period ended is presented below:  

 

Service Only Share Options

 

 

Performance Based Share Options

 

 

Market Awards

 

 

Total Share Options

 

Service Only Share Options

 

 

Performance Based Share Options

 

 

Market Awards

 

 

Total Share Options

 

Outstanding shares at December 31, 2021

 

1,129,126

 

 

 

599,994

 

 

 

27,600

 

 

 

1,756,720

 

 

1,129,126

 

 

 

599,994

 

 

 

27,600

 

 

 

1,756,720

 

Granted

 

21,900

 

 

 

-

 

 

 

-

 

 

 

21,900

 

 

456,300

 

 

 

-

 

 

 

-

 

 

 

456,300

 

Exercised

 

(125

)

 

 

-

 

 

 

-

 

 

 

(125

)

 

(125

)

 

 

-

 

 

 

-

 

 

 

(125

)

Expired

 

(2,275

)

 

 

-

 

 

 

-

 

 

 

(2,275

)

 

(5,025

)

 

 

(6,900

)

 

 

(27,600

)

 

 

(39,525

)

Forfeited

 

(5,050

)

 

 

-

 

 

 

-

 

 

 

(5,050

)

 

(41,175

)

 

 

-

 

 

 

-

 

 

 

(41,175

)

Outstanding shares at March 31, 2022

 

1,143,576

 

 

 

599,994

 

 

 

27,600

 

 

 

1,771,170

 

Exercisable at March 31, 2022

 

592,085

 

 

 

319,219

 

 

 

-

 

 

 

911,304

 

Outstanding shares at September 30, 2022

 

1,539,101

 

 

 

593,094

 

 

 

-

 

 

 

2,132,195

 

Exercisable at September 30, 2022

 

668,137

 

 

 

364,258

 

 

 

-

 

 

 

1,032,395

 

 

 

Restricted Stock Units

Restricted stock units (“RSUs”) are granted to executives as part of their long-term incentive compensation. RSUs granted prior to the 2020 Plan arise out of contracts between the Company'sCompany’s former parent company, AVITA Medical and the holders of such securities.  RSUs granted as a result of stockholder approval at the December 22, 2021 Annual General Meeting (“AGM”) arise out of contracts between the Company and the holders of such securities.  These RSU awards were approved by the Compensation Committee as determined necessary.  All RSU awards have a contractual term of 10 years and vest in accordance with the tenure or performance conditions as determined by the Compensation Committee and set out in the contracts between the Company and the holders of such securities.  The grant date fair value is determined based on the price of the Company stock price on the date of grant (stock price determined on NASDAQNasdaq post Redomiciliation and ASX prior to the Redomiciliation). RSUs primarily consist of awards to the Former CEO and other executives as well as Non-Executive Directors (as occurred following the 2021 AGM). The Former CEO RSU awards are described below.


 

A summary of the status of the Company’s unvested RSUs as of March 31,September 30, 2022, and changes that occurred during the year is presented below:

 

Service Condition RSU

 

 

Performance Condition RSU

 

 

Market Condition

 

 

Total RSU's

 

Service Condition RSU

 

 

Performance Condition RSU

 

 

Market Condition

 

 

Total RSU's

 

Unvested RSUs outstanding at December 31, 2021

 

114,757

 

 

 

135,093

 

 

 

47,640

 

 

 

297,490

 

 

114,757

 

 

 

135,093

 

 

 

47,640

 

 

 

297,490

 

Granted

 

334,450

 

 

 

-

 

 

 

-

 

 

 

334,450

 

Vested

 

-

 

 

 

(29,713

)

 

 

-

 

 

 

(29,713

)

 

(47,507

)

 

 

(57,527

)

 

 

-

 

 

 

(105,034

)

Unvested RSUs outstanding at March 31, 2022

 

114,757

 

 

 

105,380

 

 

 

47,640

 

 

 

267,777

 

Forfeited

 

(5,850

)

 

 

(11,920

)

 

 

(47,640

)

 

 

(65,410

)

Unvested RSUs outstanding at September 30, 2022

 

395,850

 

 

 

65,646

 

 

 

-

 

 

 

461,496

 

 

2019 Former CEO RSUs

 

On November 2019, the equivalent of 395,542 RSUs were issued to the Former CEO with the following vesting terms:

 

a)

Tenure – the equivalent of 142,521 RSUs with a vesting period of three-years commencing on JuneSeptember 1, 2020.  On September 1, 2022, the last tranche of 47,507 RSUs vested and were appropriately released.  As of March 31,September 30, 2022, a total of 47,507no RSUs are outstanding from this award.

 

b)

Milestone performance – 253,021 of the RSUs willwould vest upon satisfaction of various performance conditions.  During the first quarter of 2022 the last performance milestone was achieved, the RSUs vested and were appropriately released.  As of March 31,September 30, 2022, all milestones have been achieved and have been released.no RSUs are outstanding from this award.

2021 AGM Awards

On December 22, 2021, as part of the Company'sCompany’s 2021 AGM, the Company'sCompany’s stockholders approved the grant of stock option awards and RSUs to the Former CEO and the Board of Directors.  These awards are referred to as the 2021 AGM awards.Awards.


 

Awards to the Former CEO under the 2021 AGM Awards

On December 22, 2021, the Former CEO was issued an aggregate 150,480 options and RSUs comprising:  

 

37,600 tenure-based options and RSUs (23,800 RSUs and 13,800 options) with 25% of those options and RSUs vesting annually commencing on December 14, 2022.

 

37,640 performance-based options and RSUs (23,840 RSUs and 13,800 options) that vest upon satisfaction of the below conditions:  

 

o

9,410 awards (5,960 RSUs and 3,450 options) - Achieve Centers for Medicare and Medicaid Services reimbursement for out-patient transitional pass-through payment code (TPT)(“TPT”) by June 30, 2022 – 9,410 awards PerformanceJune30, 2022. This performance condition was met during the quarter ended March 31, 2022 resulting in the 5,960 RSUs vesting and 5,960 shares of common stock being issued in respect of thethose vested RSUs, andas well as the 3,450 options vesting (although theythose vested options have not been exercised by the Former CEO as at the date of this Form 10-Q).     

 

o

9,410 awards (5,960 RSUs and 3,450 options) - Achieve Japanese approval from Pharmaceuticals and Medical Device Agency (PMDA)(“PMDA”) and reimbursement code by September 30, 2022. This performance condition was met during the quarter ended September 30, 2022, resulting in the RSUs vesting and 5,960 shares of common stock being issued in respect of those vested RSUs, as well as the 3,450 options vesting (although those vested options have not been exercised by the Former CEO as at the date of this Form 10-Q).

 

o

9,410 awards (5,960 RSUs and 3,450 options) - Achieve profitability of the Company’s Burns business for two consecutive quarters by March 31, 20232023. These awards were unvested as at the date of termination of the Former CEO's employment.

 

o

9,410 awards (5,960 RSUs and 3,450 options) - Achieve US FDA approval of vitiligo indication by December 31, 20232023. These awards were unvested as at the date of termination of the Former CEO's employment.

 

75,240 stretch-performance based options and RSUs (47,640 RSUs and 27,600 options) that vest upon satisfaction of the below conditions:

 

o

37,620 (23,820 RSUs and 13,800 options) - Achieve a doubling based on a 10-day volume-weighted average price (“VWAP”VWAP) of the Company’s share price as of the date of the 2021 Annual Meeting (being December 14, 2021) by JuneSeptember 30, 2023.  The target share price is $25.74.  These awards were unvested as at the date of termination of the Former CEO's employment.

 

o

37,620 (23,820 RSUs and 13,800 options) - Achieve a market capitalization of the Company of greater than or equal to US$1.25 billion (as compared to market capitalization of ~US$435M as of October 14, 2021) and maintain that market capitalization for at least 30 consecutive calendar days on or before December 31, 2024.  These awards were unvested as at the date of termination of the Former CEO's employment.


In order for anyaccordance with the terms of the RSU Agreement and Option Agreements with the Former CEO, unvested performance-based and market condition RSUs were forfeited on the date of termination and unvested performance-based and market conditions options orexpired on the date of termination. Per the terms of the RSU and Option Agreements, RSUs issuedand options that were granted and are tenure-based only will continue to vest as long as the Former CEO continues to provide services to the CEO to vest, both the service condition and the relevant performance or market condition (as set out in the relevant agreement between the Company and the CEO) must be satisfied. The market awards will partially vest upon satisfaction of the market condition, and the other portions will vest on the anniversary of the vesting condition or December 22 of the relevant year.  The VWAP condition hasas a minimum of three potential tranches and the market capitalization award has a minimum of two potential tranches.  For market-based awards, share-based compensation expense will be recognized over the longer of the expected achievement period for the relevant market condition and the service condition. The market condition period and the valuation of each tranche were determined using a Monte Carlo simulation. In the event the market condition is met prior to the expected achievement period, any then-unrecognized compensation expense associated with the options or RSUs that have vested with respect to both the market condition and the service condition will be recognized immediately in the Company’s consolidated statements of operations.Board Member.

 

Awards to the Board of Directors under the 2021 AGM Awards

 

The Board of Director awards that were granted in 2021 consist of an aggregate 68,600 options and RSUs as follows:

 

 

41,400 tenure-based options and RSUs (15,300 options and 26,100 RSUs) vesting 12-months12 months from the grant date.date

 

o

6,900 tenure-based options and RSUs (4,350 RSUs and 2,550 options) were granted to each of the six non-executive board members based on the vesting terms detailed above.

 

 

27,200 tenure-based options and RSUs (9,850 options and 17,350 RSUs) vesting on the first, second and third anniversary of the grant date in equal amounts (i.e. 1/3 of the RSUs and options will vest on each anniversary of the grant date, being on December 22 of each relevant year).

o13,600 tenure-based options and RSUs (8,675 RSUs and 4,925 options) were granted to Jan Stern Reed and James Corbett as an initial grant in connection with their appointment to the Board of Directors.

o

13,600 tenure-based options and RSUs (8,675 RSUs and 4,925 options) granted to Jan Stern Reed and James Corbett as an initial grant in connection with their appointment to the Board of Directors.


16. Income Taxes

 

At December 31, 2021, the Company and its subsidiaries had net operating loss carryforwards for federal, state, United Kingdom, and Australian income tax purposes of $122.0 million, $79.7 million, $31.9 million and $38.2 million respectively. The net operating loss carryforwards may be subject to limitation regarding their utilization against taxable income in future periods due to “change of ownership” provisions of the Internal Revenue Code and similar state and foreign provisions. Of these carryforwards, $21.7 million will expire, if not utilized, between 2026 through 2038. The state carryforwards begin to expire between 2026 through 2041. The remaining carryforwards have no expiration. The Company is forecasting current year losses and has full valuation allowances against its deferred tax assets. Tax expense for the three monthsthree-months ended March 31,September 30, 2022 and 2021 of $4,000 and $10,000,$6,000, respectively, is related to state minimum taxes. Tax expense for the nine-months ended September 30, 2022 and 2021, is $12,000 and $23,000, respectively.

In assessing the recoverability of its deferred tax assets, the Company considers whether it is more likely than not that its deferred assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income in those periods in which temporary differences become deductible and/or net operating losses can be utilized. The Company considers all positive and negative evidence when determining the amount of the net deferred tax assets that are more likely than not to be realized. This evidence includes, but is not limited to, historical earnings, scheduled reversal of taxable temporary differences, tax planning strategies and projected future taxable income. Based upon the weight of available evidence including the uncertainty regarding the Company’s ability to utilize certain net operating losses and tax credits in the future, the Company has established a valuation allowance against its net deferred tax assets of $51.3 million and $46.9 million as of December 31, 2021 and 2020, respectively. The deferred tax assets are primarily net operating loss carryforwards for which management has determined it is more likely than not that the deferred tax assets will not be realized.

The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements related to a particular tax position are measured based on the largest benefit that has a greater than a 50% likelihood of being realized upon settlement. The amount of unrecognized tax benefits is adjusted as appropriate for changes in facts and circumstances, such as significant amendments to existing tax law, new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, or resolution of an examination.

The Company has 0tnot identified any uncertain tax positions as of March 31,September 30, 2022 or December 31, 2021.

The Company files income tax returns in the U.S. federal, California and certain other state and foreign jurisdictions. The Company remains subject to income tax examinations for its U.S. federal and state income taxes generally for fiscal years ended


June 30, 2006 and forward. The Company also remains subject to income tax examinations for international income taxes for fiscal years ended June 30, 2018 through June 30, 2021, and for certain other U.S. state and local income taxes generally for the fiscal years ended June 30, 2018 through June 30, 2021.  

17. Net Loss per Share

The following is a reconciliation of the basic and diluted loss per share computations:

 

 

Three months ended March 31,

 

 

Three-Months Ended September 30,

 

 

Nine-Months Ended September 30,

 

 

(in thousands, except per share data)

 

 

(in thousands, except per share data)

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net Loss

 

$

(9,463

)

 

$

(5,997

)

 

$

(5,588

)

 

$

(5,948

)

 

$

(21,312

)

 

$

(16,663

)

Weighted-average common shares – outstanding, basic

 

 

24,938

 

 

 

22,734

 

 

 

25,007

 

 

 

24,905

 

 

 

24,972

 

 

 

24,175

 

Weighted-average common shares – outstanding, diluted

 

 

24,938

 

 

 

22,734

 

 

 

25,007

 

 

 

24,905

 

 

 

24,972

 

 

 

24,175

 

Net loss per common share, basic

 

$

(0.38

)

 

$

(0.26

)

 

$

(0.22

)

 

$

(0.24

)

 

$

(0.85

)

 

$

(0.69

)

Net loss per common share, diluted

 

$

(0.38

)

 

$

(0.26

)

 

$

(0.22

)

 

$

(0.24

)

 

$

(0.85

)

 

$

(0.69

)

 

The Company’s basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the relevant period. In accordance with ASC 710-10, 17,927 shares of common stock held by the rabbi trust are excluded from the denominator in the basic and diluted EPS calculations. For details on shares of common stock held by the rabbi trust refer to Note 18. For the purposes of the calculation of diluted net loss per share, options to purchase common stock,


restricted stock units and unvested shares of common stock issued upon the early exercise of stock options have been excluded from the calculation of diluted net loss per share as their effect is anti-dilutive. Because the Company has reported a net loss for the three monthsand nine-months ended March 31,September 30, 2022, and 2021, diluted net loss per common share is the same as the basic net loss per share for those periods.

18. Retirement Plans

The Company offers a 401(k)-retirement savings plan (the “401(k) Plan”) for its employees, including its executive officers, who satisfy certain eligibility requirements. The Internal Revenue Code of 1986, as amended, allows eligible employees to defer a portion of their compensation, within prescribed limits, on a pre-tax basis through contributions to the 401(k) Plan. The Company matches contributions to the 401(k) Plan based on the amount of salary deferral contributions the participant makes to the 401(k) Plan. The Company will match up to 6% of an employee’s compensation that the employee contributes to his or her 401(k) Plan account. Total Company matching contributions to the 401(k) Plan were $233,000$312,000 and $221,000$183,000 in the three monthsthree-months ended March 31,September 30, 2022 and 2021, respectively.respectively, and $783,000 and $606,000 in the nine-months ended September 30, 2022 and 2021.

DeferredNon-qualified deferred compensation plansplan

The Company’s Deferred Compensation Plannon-qualified deferred compensation plan (the "DCP""NQDC plan"), which became effective on October 2021 allows for eligible management and highly compensated key employees to elect to defer a portion of their salary, bonus, commissions and RSU awards to later years. TheseCash deferrals are immediately vested and are subject to investment risk and a risk of forfeiture under certain circumstances. TheRSU deferrals are subject to the vesting conditions of the award. Once RSUs vest, subject to a six-month and one day holding period, employees are allowed to diversify the common stock into other investment options offered by the plan.  For cash deferrals, the Company matches 4% to 6% (depending on level) of employee contributions. These matching employer contributions are vested over a two-year period with 25% vesting on year one and 75% vesting on year two for employees under 55 years old. Forof age. Employer contributions for employees over 55 years old employer contributionsof age are immediately vested. Employer contributions to the DCPNQDC plan were $84,000$75,000 and $0 for the three monthsthree-months ended March 31,September 30, 2022 and 2021, and $197,000 and $0 for the nine-months ended September 30, 2022 and 2021. The Company’s deferred compensation plan liability was $571,000$1 million and $262,000 as of March 31,September 30, 2022 and December 31, 2021, respectively, and is included in other long-term liabilities.non-qualified deferred compensation plan liability in the Consolidated Balance Sheets.

 

The Company established a COLI to fund the DCP. The COLI is subject to creditor claims in the event of insolvency, but the assets held in the COLI are not available for general corporate purposes.NQDC plan. Amounts in the COLI are invested in a number of funds. The securities are carried at the cash surrender value and are included in other long-term assets on the Consolidated Balance Sheets. We record investment gains and losses in operating expenses onof the Consolidated Statements of Operations, along with the offsetting amount related to the increase or decrease in deferred compensation liability.COLI as other income.


 

The fair values of the Company’s deferred compensation plan assets and liability are included in the table below. For additional information on the fair value hierarchy and the inputs used to measure fair value, see Note 5, Fair Value Measurements.

 

 

 

Fair Value as of March 31, 2022

 

Fair Value as of December 31, 2021

 

 

Level 1

 

Level 2

 

Level 3

 

Total

 

Level 1

 

Level 2

 

Level 3

 

Total

Corporate-owned life insurance policies (1)

 

-

 

586

 

-

 

586

 

-

 

304

 

-

 

304

 

 

Fair Value as of September 30, 2022

 

 

Fair Value as of December 31, 2021

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Corporate-owned life insurance policies (1)

 

 

-

 

 

948

 

 

 

-

 

 

948

 

 

 

-

 

 

304

 

 

 

-

 

 

304

 

Non-qualified deferred compensation plan liability (2)

 

 

-

 

 

 

1,016

 

 

 

-

 

 

 

1,016

 

 

 

-

 

 

 

262

 

 

 

-

 

 

 

262

 

 

(1)The corporate-owned life insurance contracts are recorded at cash surrender value, which is provided by a third party and reflects the net asset value of the underlying publicly traded mutual funds and are categorized as Level 2.

(2)Non-qualified deferred compensation plan liability is measured at fair value based on quoted prices of identical instruments to the investment vehicles selected by the participants.


Rabbi Trust

During April 2022, we 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 RSU awards that have vested.  The NQDC permits 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.  As of September 30, 2022, a total of 253,048 shares awards have been deferred, and during the quarter ended September 30, 2022, a total of 17,927 awards vested.  Vested shares are converted to common stock and are reclassified to permanent equity.  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 Common stock held by the NQDC plan.  A total of 17,927 shares were vested at the redemption value of $127,000.

The following table summarizes the eligible share award activity as of September 30, 2022, and December 31, 2021 (in thousands):

As of

September 30, 2022

December 31, 2021

Non-qualified deferred compensation share awards:

Balance at inception/beginning of period

-

-

Change in classification of deferred compensation share awards

192

-

Share-based compensation expense

287

-

Change in redemption value

(80

)

-

Vesting of share awards held by NDQC

(127

)

-

Ending Balance

272

-

 

 

19. Subsequent Events

The Company has evaluated subsequent events through the filing of this Quarterly Report on Form 10-Q and determined that there have been no events that have occurred that would require adjustments to our disclosures in the consolidated financial statements.


Item 2.

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

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q.

Our actual results and timing of certain events may differ materially from the results discussed, projected, anticipated, or indicated in any forward-looking statements. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Quarterly Report on Form 10-Q. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report on Form 10-Q, they may not be predictive of results or developments in future periods.

The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report on Form 10-Q, including those risks identified under Part II, Item 1A. Risk Factors.

We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC and the ASX, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Overview

The AVITA group of companies (comprising AVITA Medical, Inc. (“AVITA”AVITA or the “Company”Company) and its subsidiaries, including AVITA Medical Pty Limited, previously known as AVITA Medical Limited, (“AVITA Medical”Medical)) (collectively, “AVITA Group”AVITA Group or “we”, “us”, or “our”) is a commercial-stage regenerative medicine company focused onleading the treatmentdevelopment and commercialization of burns, traumadevices and other acute injuries, together withautologous cellular therapies for skin defects like vitiligo.restoration. The Company’s lead product is the RECELL® System technology platform harnesses the regenerative properties of a device that enables healthcare professionalspatient’s own skin to produce a suspension ofcreate Spray-On Skin™ Cells using a small sample of the patient’s own skin.cells. In September 2018, the United States Food & Drug Administration (“FDA”FDA) granted premarket approval (“PMA”PMA) to the RECELL System for use in the treatment of acute partial-thickness thermal burns or application in combination with meshed autografting for acute full-thickness thermal burn wounds in patients eighteen years and older. Following receipt of our original PMA, we commenced commercializingcommercialization of the RECELL System in January 2019 in the United States. In June 2021, the FDA approved an expanded indicationits approval to include treatment of pediatric acute full-thickness thermal burns.wounds in combination of meshed autografting. In February 2022, the FDA approved a PMA supplement for the RECELL®RECELL Autologous Cell Harvesting Device with, an enhanced ease-of-use device aimed at providing clinicians a more efficient user experience and simplified workflow. In addition, the FDA has granted the Company Investigational Device Exemptions (“IDEs”IDEs”), which have enabled the Company to initiate pivotal clinical trials to further expand the approval of the RECELL System for the treatment of soft tissue reconstructionrepair and vitiligo. Enrollment of those clinical trials is complete, with topline results recently announced for both the soft tissue repair and if successful,vitiligo trials. Results from those studies would enableare intended to support the Company to seekCompany’s pursuit of FDA approval to market the RECELL System in the United States infor those indications.

The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, and simultaneouslywhile significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care as a standalone product, or in combination with “skin grafts”, known as split-thickness skin autografts, depending on the depth of the burn injury. The pivotal studies leading to the RECELL System’s FDA premarket approval (“PMA”) for the treatment of acute thermal burns, demonstrated that the RECELL System treated burns using 97.5 percent97.5-percent less donor skin when used alone in second-degree burns, and 32 percent32-percent less donor skin when used with autograft for third-degree burns compared to standard of care autografting. In these studies, a statistically significant reduction in donor skin required to treat burn patients with the RECELL System was realized without any associated compromise to healing or safety outcomes. Donor site outcomes from the clinical trial for second-degree burns also revealed a statistically significant reduction in patient-reported pain, increased patient satisfaction and improved scar outcomes.

Our compelling data from prospective, randomized, controlled clinical trials conducted at major United States burn centers, health economics modeling, and real-world use globally demonstrate that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings.

The RECELL System has received various approvals and registrations in international markets. The RECELL System is Therapeutic Goods Administration (“TGA”) registeredTGA-registered in Australia, cleared for use in the treatment of burns, acute wounds, scars and vitiligo. In Europe, the RECELL System received CE-mark approval for the treatment of burns, chronic wounds, scarsin Europe, and vitiligo. In February 2019, our marketing partner COSMOTEC filed areceived Japan’s Pharmaceuticals and Medical Devices Act (“PMDA”PMDA) applicationapproval for approval to market the RECELL Systemburns in Japan forand has begun commercialization. Presently, other than in the treatment of burnsU.S. and other wounds. In February 2022, COSMOTEC’s application for regulatory approval was approved by the PMDA with labelling for


treatment of burns. Presently,Japan we are not actively marketing the RECELL System internationally and therefore do not derive meaningfulmaterial revenue from the RECELL System in theseAustralia, Europe or other markets.


Our website address is www.avitamedical.com. Information contained on our website is not part of or incorporated into this report. We make our periodic reports, together with any amendments, available on our website, free of charge, as soon as reasonably practicable after we electronically file or furnish the reports with the Securities and Exchange Commission (“SEC”) or with the Australian Securities Exchange (“ASX”). The SEC maintains an internet site, www.sec.gov, which contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. Copies of announcements made by the Company to the ASX are available on ASX’s website (www.asx.com.au).

Corporate History

AVITA Medical, the former parent company of the AVITA Group, began as a laboratory spin-off in the Australian State of Western Australia. Clinical Cell Culture (C3)(“C3”) (being the prior name of AVITA Medical) was formed under the laws of the Commonwealth of Australia in December 1992 and has operated as AVITA Medical since 2008. AVITA Medical’s ordinary shares originally began trading in Australia on the Australian Securities Exchange (“ASX”) on August 9, 1993. AVITA Medical’s American Depositary Shares (“ADSs”) traded over the counter on the OTCQX under the ticker symbol “AVMXY” from May 14, 2012, through September 30, 2019, and its ADSs began trading on the NASDAQNasdaq Capital Market on October 1, 2019, under the ticker symbol “RCEL”.

The Company’s CDI’sCHESS Depositary Interests (“CDIs”) are quoted on the ASX under AVITA Medical’s former ASX ticker code, “AVH”. The Company’s shares of common stock are quoted on NASDAQNasdaq under AVITA Medical’s former NASDAQNasdaq ticker code, “RCEL”. One share of common stock on NASDAQNasdaq is equivalent to five CDIs on the ASX.

COVID-19 Business Update and Risks Associated with COVID-19

Beginning in

The ongoing pandemic caused by the first quarterspread of 2020, the ongoing coronavirus (“COVID-19”COVID-19) pandemic has created significant disruptions to the U.S. and global economies and financial markets.  InThe global impact of the pandemic has fluctuated since early 2020.  At times, in the United States, Statestate and Local Governmentallocal governmental authorities have responded by issuing orders, of varying degrees, requiring quarantines, restrictions on travel and minimizing social gathering/interactions and mandatory closures of certain non-essential businesses, as well as providing recommendations to minimize social gatherings or interactions. Due to such orders, the COVID-19 pandemic began impacting our operations and financial results.  For example, on March 19, 2020, the Executive Departmentbusinesses. Many of the State of California issued Executive Order N-33-20, ordering all individualsrestrictions have been periodically updated as infection rates in the State of California to stay at home or at their place of residence exceptU.S. have risen and fallen, as needed to maintain continuity of operations of federal critical infrastructure sectors. Our primary operations are located in Valencianew variants have emerged, as vaccines have become available, and Ventura, California. new information about transmission has been discovered.

In response to the pandemic, we took certain business measures which included institutionacted swiftly by implementing protocols to ensure continuity of various workplace protectionsour manufacturing, increasing our safety stock and to ensureprovide for the safety of our employees (e.g., wearing of masks, wiping down high touch areas, etc.), and the limiting of vendors and visitors to our facilities. Essential staff in manufacturing and limited support functions have continued to work from our locations following appropriate hygiene and social distancing protocols. To reduce the risk to our employees and their families from potential exposure to COVID-19, we limited activities at our corporate headquarters, encouraged our employees to work from home, encouraged virtual meetings, restricted non-essential business travel, made physical modifications and enhancements to our facilities to effect social distancing, and provided personal protective equipment to our employees.  We have increased safety stocks of our product, established temporary satellite product storage locations, and accelerated initiatives to increase sourcing options. However, as most restrictions have now been lifted, we have resumed in-office work at our corporate headquarters on a hybrid work schedule for some of our employees and have lifted non-essential business travel as more states and countries begin to lift travel restrictions.  Throughout the pandemic, we have remained focused on managing the business for the long-term, including maintaining our employee workforce as well as continuing to invest in critical research and development, clinical, and corporate infrastructure-related programs.

The global COVID-19 pandemic presents significant risks to us and may have far reaching impactsEarly on, our business and operations and financial results and condition, directly and indirectly, including, without limitation, impacts on:were impacted by the healthongoing effects of our managementthe pandemic with restrictions on travel and employees; manufacturing, distribution, marketing and sales operations; research and development activities, including clinical activities; and customer and patient behaviors. Moreover, beginning in March 2020, access to hospitals and other customer sites was restricted to essential personnel, which has negatively impacted our ability to promote the usecustomers or temporary suspension of the RECELL System with physicians, and to enroll our clinical studies. In addition, some hospitals and other burn centers suspended the treatment of burn patients or re-distributedre-distribution of those patients to other treatment facilities and together with a general reduction in broader economic activity (e.g., reduced travel, reduced mobility, suspension of certain business operations, etc.), this resulted in a reduction in the volume of burn procedures using the RECELL System in the immediate period following the implementation of those protective measures.  In addition, we experienced periodic enrollment cessation in our clinical trials due to COVID-19 as well as having individuals excluded because they have contracted COVID-19.due to contracting the virus.

 


We are continuing to monitorAs of the date of this filing, with the continued overall decrease in COVID-19 infections and hospitalizations we have resumed on-site work schedules for all employees.  Thus far, 2022 the impact of COVID-19 has decreased as compared to 2021 for our business and operations; however, COVID-19 pandemic around the world, and particularly in the United States, continues to present risks to the Company. While the COVID-19 pandemic has not materially adversely affected our financial results and business operations through the third quarter ended September 30, 2022, we are unable to predict the impact that COVID-19 will have on our employees, customers,business, operations, and financial results and condition because of the numerous uncertainties created by the unprecedented nature of the pandemic. We are closely monitoring the evolving impact of the pandemic on all aspects of our business. We have implemented a number of measures designed to protect the markets in which we operate. We will take further actions that we consider prudent to address the COVID-19 pandemic, including reducing spending, while ensuring that we canhealth and safety of our employees, support our customers and promote business continuity. We continue to develop our products. The ultimate extent ofevaluate the impact ofCompany’s liquidity and operational performance, communicate with and monitor the COVID-19 pandemic on us, including the discovery and spread of existing and future contagious variants to COVID-19, remains highly uncertain and will depend on future developments and factors that continue to evolve. These factors, among others include the widespread vaccination of populations including recently approved booster regimens, especially in the U.S. and improvements in treatments and therapeutics for those with COVID-19, which are outsideactions of our control, and could exist for an extended period of time even after the pandemic might end. Further imposition of quarantines, shelter-in-place and similar government orders which are outside of our control have also impacted and could continue to impact ourcustomers, third-party manufacturers and suppliers, which could in turn adversely impactand review our near-term financial performance as we manage the availability or costCompany through this period of materials, which could disrupt our supply chain. uncertainty.


Results of Operations for the three monthsthree-months ended March 31,September 30, 2022 compared to the three monthsthree-months ended March 31,September 30, 2021.

The table below summarizes the results of our continuing operations for each of the periods presented (in thousands).

 

 

Three Months Ended March 31,

 

 

 

 

 

 

 

 

 

 

Three-Months Ended September 30,

 

 

 

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change ($)

 

 

% Change

Favorable/(Unfavorable)

 

 

2022

 

 

2021

 

 

Change ($)

 

 

% Change

Favorable/(Unfavorable)

 

Revenues

 

$

7,539

 

 

$

8,765

 

 

$

(1,226

)

 

 

(14

%)

 

$

9,092

 

 

$

7,020

 

 

 

2,072

 

 

 

30

%

Cost of sales

 

 

(1,778

)

 

 

(2,146

)

 

 

368

 

 

 

17

%

 

 

(1,530

)

 

 

(1,088

)

 

 

(442

)

 

 

(41

%)

Gross profit

 

 

5,761

 

 

 

6,619

 

 

 

(858

)

 

 

(13

%)

 

 

7,562

 

 

 

5,932

 

 

 

1,630

 

 

 

27

%

BARDA income

 

 

734

 

 

 

570

 

 

 

164

 

 

 

29

%

 

 

904

 

 

 

374

 

 

 

530

 

 

 

142

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing expenses

 

 

(4,828

)

 

 

(3,649

)

 

 

(1,179

)

 

 

(32

%)

 

 

(5,411

)

 

 

(3,518

)

 

 

(1,893

)

 

 

(54

%)

General and administrative expenses

 

 

(7,534

)

 

 

(5,422

)

 

 

(2,112

)

 

 

(39

%)

 

 

(5,004

)

 

 

(5,349

)

 

 

345

 

 

 

6

%

Research and development expenses

 

 

(3,620

)

 

 

(4,109

)

 

 

489

 

 

 

12

%

 

 

(3,799

)

 

 

(3,388

)

 

 

(411

)

 

 

(12

%)

Total operating expenses

 

 

(15,982

)

 

 

(13,180

)

 

 

(2,802

)

 

 

(21

%)

 

 

(14,214

)

 

 

(12,255

)

 

 

(1,959

)

 

 

(16

%)

Operating loss

 

 

(9,487

)

 

 

(5,991

)

 

 

(3,496

)

 

 

(58

%)

 

 

(5,748

)

 

 

(5,949

)

 

 

201

 

 

 

3

%

Interest expense

 

 

-

 

 

 

(3

)

 

 

3

 

 

 

100

%

 

 

(6

)

 

 

(9

)

 

 

3

 

 

 

33

%

Other income

 

 

28

 

 

 

7

 

 

 

21

 

 

 

300

%

 

 

170

 

 

 

16

 

 

 

154

 

 

 

963

%

Loss before income taxes

 

 

(9,459

)

 

 

(5,987

)

 

 

(3,472

)

 

 

(58

%)

 

 

(5,584

)

 

 

(5,942

)

 

 

358

 

 

 

6

%

Income tax expense

 

 

(4

)

 

 

(10

)

 

 

6

 

 

 

60

%

 

 

(4

)

 

 

(6

)

 

 

(2

)

 

 

(33

%)

Net loss

 

$

(9,463

)

 

$

(5,997

)

 

$

(3,466

)

 

 

(58

%)

 

$

(5,588

)

 

$

(5,948

)

 

 

360

 

 

 

6

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total net revenues decreased 14%increased by 30%, or $2.1 million, to $7.5$9.1 million, compared to $8.8$7.0 million in the corresponding period in the prior year. Our commercial revenue, which excludes BARDA revenue, was $9.0 million in the three-months ended September 30, 2022, an increase of $2.1 million or 30%, compared to $6.9 million in the corresponding period in the prior year. The decreasegrowth in the current year revenueicommercial revenues was largely driven by deeper penetration within individual customer accounts along with the commencement of commercial sales with our recognition of $4.1 millionpartner COSMOTEC in Biomedical Advanced Research and Development Authority (“BARDA”) related revenue in the prior year resulting from our delivery of unitsJapan.

Gross profit margin decreased by 2% to managed inventory for BARDA for emergency response preparedness.  Our commercial revenue in the current year increased by $2.8 million or 61%,83% compared to the corresponding period in the prior year. The increase in commercial sales was largely driven by broader utilization among our customer base as well as deeper penetration within individual customer accounts.

Gross profit margin was 76% and is flat compared to the corresponding period in the prior year. In the prior year our gross margins were lower compared to historical periods due to the lower price point associated with units that were delivered to managed inventory for BARDA as the BARDA contract was negotiated prior to establishing a higher price point through commercialization in the United States.  In the current quarter gross margins were lower than historical periods due to reduced production and higher average production costs at our Ventura facility.

 

BARDA income increased 29%by 142%, or $0.5 million, to $734,000,$0.9 million, compared to $570,000$0.4 million for the corresponding period in the prior year.  BARDA income consisted of funding from the Biomedical Advanced Research and Development Authority, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under ongoing USG Contract No. HHSO100201500028C. BARDA income increased as a result of funding by BARDA for the pivotal trial for use of the RECELL System for soft tissue reconstruction.

 

Total operating expenses increased 21%by 16% or $2.8$2.0 million to $16.0$14.2 million, compared with $13.2$12.3 million in the corresponding period in the prior year.

 

Sales and marketing expenses increased 32%by 54%, or $1.2$1.9 million, to $4.8$5.4 million, compared to $3.6$3.5 million incurred in the corresponding period in the prior year. Higher costs in the current year were primarily attributed to higher salaries and benefits, selling expenses, pre-commercialization costs and share-based compensation expenses. Increase in salaries and benefits primarily resulted from additional field personnel added to deepen penetration within individual customer accounts. Higher selling expenses resulted from an increase in travel costs due to fewer COVID-19 travel restrictions in the current year, along with higher commissions associated with the increase in revenues. Increased pre-commercialization costs are primarily due to planning for future RECELL launches in soft tissue reconstruction and vitiligo.  Higher share-based compensation expenses were due to our adoption of a long-term incentive plan to encourage and reward shareholder value creation in the business.

General and administrative expenses decreased by 6%, or $0.3 million, to $5.0 million, compared to $5.3 million incurred in the same period in the prior year. The decrease was primarily due to lower share-based compensation expenses, lower professional fees, partially offset by severance costs associated with the termination of a former executive employee. Lower share-based compensation expenses in the current quarter resulted from certain performance milestones being met in the prior year, along with the reversal of previously recognized expense for unvested awards related to the termination of an executive employee in the current year. Lower professional fees incurred in the current year resulted from the company changing from a fiscal year to a calendar year.


Research and development expenses increased by 12%, or $0.4 million, to $3.8 million, compared to $3.4 million incurred in the same period in the prior year.  The increase was a result of ongoing development of next generation devices for more automated preparation of Spray-On Skin Cells   The increase was partially offset by lower clinical trial expenses for soft tissue reconstruction and vitiligo as trial participants were in less costly follow-up phases this period compared to more costly recruitment and treatment phases in the prior period.

Results of Operations for the nine-months ended September 30, 2022 compared to the nine-months ended September 30, 2021.

The table below summarizes the results of our continuing operations for each of the periods presented (in thousands).

 

 

Nine-Months Ended September 30,

 

 

 

 

 

 

 

 

 

 

 

2022

 

 

2021

 

 

Change ($)

 

 

% Change

Favorable/(Unfavorable)

 

Revenues

 

$

24,966

 

 

$

26,089

 

 

 

(1,123

)

 

 

(4

%)

Cost of sales

 

 

(4,694

)

 

 

(5,287

)

 

 

593

 

 

 

11

%

Gross profit

 

 

20,272

 

 

 

20,802

 

 

 

(530

)

 

 

(3

%)

BARDA income

 

 

2,189

 

 

 

1,384

 

 

 

805

 

 

 

58

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing expenses

 

 

(15,571

)

 

 

(11,313

)

 

 

(4,258

)

 

 

(38

%)

General and administrative expenses

 

 

(18,009

)

 

 

(16,046

)

 

 

(1,963

)

 

 

(12

%)

Research and development expenses

 

 

(10,478

)

 

 

(11,471

)

 

 

993

 

 

 

9

%

Total operating expenses

 

 

(44,058

)

 

 

(38,830

)

 

 

(5,228

)

 

 

(13

%)

Operating loss

 

 

(21,597

)

 

 

(16,644

)

 

 

(4,953

)

 

 

(30

%)

Interest expense

 

 

(10

)

 

 

(21

)

 

 

11

 

 

 

52

%

Other income

 

 

307

 

 

 

25

 

 

 

282

 

 

 

1128

%

Loss before income taxes

 

 

(21,300

)

 

 

(16,640

)

 

 

(4,660

)

 

 

(28

%)

Income tax expense

 

 

(12

)

 

 

(23

)

 

 

11

 

 

 

48

%

Net loss

 

$

(21,312

)

 

$

(16,663

)

 

 

(4,649

)

 

 

(28

%)

Total net revenues decreased by 4%, or $1.1 million, to $25.0 million, compared to $26.1 million in the corresponding period in the prior year. The decrease in the current year revenue was driven by our recognition of $7.8 million in BARDA related revenue in the prior year resulting from our delivery of units to managed inventory for BARDA for emergency response preparedness.  Our commercial revenue, which excludes BARDA revenue, increased 35% or $6.5 million to $24.7 million, compared to $18.2 million in corresponding period in the prior year.  The growth in commercial revenues was largely driven by an increase in field personnel and travel to


expand our market coverage, increased hands-on professional education and training events along with higher pre-commercialization costs.  Higher costs for travelthe number of customers ordering as well as professionalthe average monthly order size for those customers.

Gross profit margin increased by 1% to 81% compared to the corresponding period in the prior year. In the prior year our gross margins were lower compared to historical periods due to the lower price point associated with units that were delivered to managed inventory for BARDA as the BARDA contract was negotiated prior to establishing a higher price point through commercialization in the United States.  

BARDA income increased by 58%, or $0.8 million, to $2.2 million, compared to $1.4 million for the corresponding period in the prior year.  BARDA income consisted of funding from the Biomedical Advanced Research and training eventsDevelopment Authority, under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under ongoing USG Contract No. HHSO100201500028C. BARDA income increased as a result of funding by BARDA for the pivotal trial for use of the RECELL System for soft tissue reconstruction.

Total operating expenses increased by 13% or $ 5.2 million to $44.1 million, compared with $38.8 million in the corresponding period in the prior year.

Sales and marketing expenses increased by 38%, or $4.3, million to $15.6 million, compared to $11.3 million incurred in the corresponding period in the prior year. Higher costs in the current period resulted from fewer COVID-19 related travel restrictions. Increasedyear were primarily attributed to higher pre-commercialization costs, salaries and benefits, selling expenses, and share-based compensation expenses.  Higher pre-commercialization costs were incurred for planning for future RECELL launches in soft tissue reconstruction and vitiligo.  Increased salaries and benefits are attributable to an increase in field personnel to further deepen the penetration within individual customer accounts.  Higher selling costs were primarily due to fewer COVID-19 travel restrictions in the current year, along with higher commissions due to an increase


in revenues.  Higher share-based compensation expenses resulted from our granting of a long-term incentive plan to encourage and reward shareholder value creation in the business.

 

General and administrative expenses increased 39%by 12%, or $2.1$2.0 million, to $7.5$18.0 million, compared to $5.4$16.0 million incurred in the same period in the prior year. The increase was primarily driven by higher salaries and benefits and share-based compensation expenses in the current quarterexpenses.  Higher salaries and benefits were associated with the acceleration of expense for certain performance milestones being meet in the current quarter. Higher compensation costs were driven by the hiring of an executive at the end of March 2021 along with expanding our workforce to support overall operations along with severance costs associated with the overall operations.termination of a former executive employee. Increased share-based compensation resulted from   certain performance milestones being met in the period, partially offset by the reversal of previously recognized expense for unvested awards related to the termination of an executive employee in the current year.

 

Research and development expenses decreased 12%by 9%, or $489 thousand$1.0 million, to $3.6$10.5 million, compared to $4.1$11.5 million recognizedincurred in the same period in the prior year.  Higher costs in the prior year were primarily driven by research and development costs associated with furthering the Company’s pipeline along with ramping up vitiligo clinical trial costs related activities for treatment of vitiligo.activities.  The favorable variance is not a purposeful reduction in spending but reflects that certain programs were in lower cost phases during this quarter.period.  The decrease in research and development was partially offset by ongoing development of a next generation device for more automated preparation of Spray-On Skin Cells in the current year.

Liquidity and Capital Resources

The Company’s short-term and long-term liquidity requirements primarily arise from funding (i) research and development expenses, (ii) general and administrative expenses including salaries, bonuses and commissions, (iii) working capital requirements. We expect to utilize cash reserves until U.S. sales of our products reach a level sufficient to fund ongoing operations. The AVITA Group has historically funded its research and development activities, and more recently its substantial investment in sales and marketing activities, through raising capital by issuing securities, and it is expected that similar funding will be obtained to provide working capital if and when required. As of March 31,September 30, 2022, the Company has sufficient cash reserves to fund operations for the next 12-months. If the Company is unable to raise capital in the future, the Company may need to curtail expenditures by scaling back certain research and development, or other programs.programs, and other expenditures.

The following table summarizes our cash flows for the periods presented (in thousands):

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Nine-Months Ended

 

(In Thousands)

 

March 31, 2022

 

 

March 31, 2021

 

 

September 30, 2022

 

 

September 30, 2021

 

Net cash used in operations

 

$

(9,370

)

 

$

(8,541

)

 

$

(15,654

)

 

$

(13,131

)

Net cash used in investing activities

 

 

(22,601

)

 

 

(362

)

 

 

(16,174

)

 

 

(50,182

)

Net cash provided by financing activities

 

 

1

 

 

 

64,028

 

 

 

1

 

 

 

64,061

 

Effect of foreign exchange rate on cash and restricted cash

 

 

(6

)

 

 

(11

)

Net increase in cash and restricted cash

 

 

(31,976

)

 

 

55,114

 

Cash and restricted cash at beginning of quarter

 

 

55,712

 

 

 

59,966

 

Cash and restricted cash at end of quarter

 

 

23,736

 

 

 

115,080

 

Effect of foreign exchange rate on cash and cash equivalents and restricted cash

 

 

(70

)

 

 

(29

)

Net increase/(decrease) in cash and cash equivalents and restricted cash

 

 

(31,897

)

 

 

719

 

Cash and cash equivalents and restricted cash at beginning of year

 

 

55,712

 

 

 

59,966

 

Cash and cash equivalents and restricted cash at end of year

 

 

23,815

 

 

 

60,685

 

 

Three monthsNine-months ended March 31,September 30, 2022, and 2021.

Net cash used in operating activities was $9.4$15.7 million and $8.5$13.1 million during the three monthsnine-months ended March 31,September 30, 2022, and 2021, respectively. The increase was primarily driven byresulted from higher operating costs partially offset by lower BARDA receivables outstanding in the current period.costs.

Net cash used in investing activities was $22.6$16.2 million and $362,000$50.2 million during the three monthsnine-months ended March 31,September 30, 2022, and 2021, respectively. Cash flows used for investing activities was primarily attributable to our investments into marketable securities.

Net cash provided by financing activities was $1,000$1 thousand and $64.0 million during the three monthsnine-months ended March 31,September 30, 2022, and 2021, respectively. The decrease in cash provided by financing activities is related to proceeds from the capital raise in March 2021.


Capital management.

We aim to manage capital so that the Company continues as a going concern while also maintaining optimal returns to stockholders and benefits for other stakeholders. We also aim to maintain a capital structure that ensures the lowest cost of capital available to the Company. We regularly review the Company’s capital structure and seek to take advantage of available opportunities to improve outcomes for the Company and its stockholders.


For the period ended March 31,September 30, 2022, there were no dividends paid and we have no plans to commence the payment of dividends. We have no purchase commitments or long-term contractual obligations as of March 31,September 30, 2022. We have no committed plans to issue further shares on the market but will continue to assess market conditions and the Company’s cash flow requirements to ensure the Company is appropriately funded in order to pursue its various opportunities.

There is no significant external borrowing at the reporting date. Neither the Company nor any of the subsidiaries are subject to externally imposed capital requirement.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements (as defined in the rules and regulations of the SEC) that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

Commitments and Contractual Obligations

The Company does not have any contractual obligations or purchase commitments, except for lease obligations for the period ended March 31,September 30, 2022. For details of lease obligations refer to Note 6 in the consolidated financial statements.

Critical Accounting Estimates

There have been no material changes to our critical accounting policies and estimates from the information provided in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in the Company’s Transition Report on Form 10-KT for the transition period ended December 31, 2021.

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

As a smaller reporting company, we are not required to provide the information required by this Item.

 

Item 4.Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our Chief Executive Officer and our Chief Financial Officer evaluated, with the participation of our management, the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. As of March 31,September 30, 2022, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures, as defined in Securities Exchange Act Rule 13a-15(e) and 15d-15(e), were effective.

Our disclosure controls and procedures have been formulated to ensure (i) that information that we are required to disclose in reports that we file or submit under the Securities Exchange Act of 1934 was recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commissionthe SEC’s rules and forms and (ii) that the information required to be disclosed by us is accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.

Changes in Internal Controls over Financial Reporting

There was no change in our internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the firstthird quarter of fiscal year 2022 covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

 


 

Part II - Other Information

Item 1.

None.

Item 1A. RISK FACTORS

In addition to the risk factors set forth below and the other information set forth in this report, you should carefully consider the factors discussed under Part I, Item 1A, “Risk Factors” in the Company’s Transition Report on Form 10-KT for the transition period ended December 31, 2021. These factors could materially adversely affect our business, financial condition, liquidity, results of operations and capital position, and could cause our actual results to differ materially from our historical results or the results contemplated by the forward-looking statements contained in this report. There have been no material changes to the risk factors described in Part I, Item 1A, “Risk Factors,” included in our 2021 Transition Report.

Risk Factors

Refer also to “COVID-19 Business Update and Risks Associated with COVID-19” in Part 1 above.

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

(a) The following exhibits are filed as part of the Quarterly Report on Form 10-Q:

 

Exhibit

No.

 

Description 

 

 

 

2.1

Scheme Implementation Agreement (incorporated by reference to Exhibit  99.2 of the registrant’s Form 6-K filed on April 20, 2020)

3.1

Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the registrant’s Form 8-K12B filed on June 30, 2020)

3.2

Certificate of Amendment of Certificate of Incorporation (incorporated by reference to Exhibit 3.2 of the registrant’s Form 10-KT filed on February 28, 2022)

3.3

Amended and Restated Bylaws (incorporated by reference to Exhibit 3.3 of the registrant’s Form 10-KT filed on February 28, 2022)

2.1

Scheme Implementation Agreement (incorporated by reference to Exhibit  99.2 of the registrant’s Form 6-K filed on April 20, 2020)

10.1

Executive Employment Agreement between the registrant and James Corbett dated September 26, 2022 †*

10.2

Amendment of Solicitation/Modification of Contract dated September 29, 2015 between the registrant and the U.S Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA)*

10.3

Amendment of Solicitation/Modification of Contract dated September 29, 2015 between the registrant and the U.S Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA)*

 

 

 

31.1

 

Rule 13a-14(a) Certification of Chief Executive Officer

 

 

 

31.2

 

Rule 13a-14(a) Certification of Chief Financial Officer

 

 

 

3232**  

 

18 U.S.C. Section 1350 Certifications

 

 

 

101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

104

 

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

† Management contract or compensation plan or arrangement

* Filed herewith

** Furnished herewith

 


 

Signatures

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

 

Date:

  May 12,November 10, 2022

 

AVITA MEDICAL, INC.

 

 

 

 

 

 

 

 

By:

/s/ Dr. Michael Perry James Corbett

 

 

 

 

Dr. Michael PerryJames Corbett

 

 

 

 

President and Chief Executive Officer

 

 

 

 

(Principal Executive Officer)

 

 

 

 

 

 

 

 

By:

/s/ Michael Holder 

 

 

 

 

Michael Holder

 

 

 

 

Chief Financial Officer

 

 

 

 

 

 

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