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Avita Medical, Inc. (RCEL) SEC Filing 8-K Material Event for the period ending Thursday, May 12, 2022

Avita Therapeutics, Inc.

CIK: 1762303 Ticker: RCEL

Exhibit 99.1

 

LOGO

AVITA Medical Reports First Quarter 2022 Financial Results

May 12, 2022

VALENCIA, Calif. and MELBOURNE, Australia, May 12, 2022 (GLOBE NEWSWIRE) — AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care

autologous skin restoration for multiple unmet needs, today reported financial results for its first quarter ended March 31, 2022.

Financial Highlights and Recent Updates:

 

   

Reported commercial revenue, which excludes BARDA revenue, of $7.4 million a 61% increase compared to $4.6 million in the corresponding period in the prior year

 

   

Reported total revenue, which includes BARDA revenue, of $7.5 million compared to $8.8 million in the corresponding period in the prior year, which included $4.1 million in BARDA revenue

 

   

In February 2022, FDA approved our premarket approval application (PMA) supplement for RECELL® Autologous Cell Harvesting Device, an enhanced RECELL system aimed at providing clinicians a more efficient user experience and simplified workflow

 

   

In February 2022, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved our application for commercialization of the RECELL system in burns

 

   

As of March 31, 2022, the Company had $95.0 million in cash, cash equivalents, and marketable securities, with no debt

“Our commercial team performed well this quarter driving further adoption and penetration within burn centers, and our clinical team continued to move the soft tissue reconstruction and vitiligo trials forward,” said Dr. Mike Perry, AVITA Medical Chief Executive Officer. “We are well positioned to drive revenue growth ahead and we look forward to topline data readouts from our soft tissue reconstruction and vitiligo clinical trials in the second half of this year.”

First Quarter of Year 2022 Financial Results

Our commercial revenue, which excludes BARDA revenue, was $7.4 million in the current year, an increase of $2.8 million or 61%, compared to $4.6 million the corresponding period in the prior year. Total revenue, which includes BARDA revenue, was $8.8 million in the corresponding period in the prior year which included $4.1 million in BARDA related revenue that resulted from our delivery of units to managed inventory for BARDA for emergency response preparedness. The increase in commercial revenue 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.

Total operating expenses increased by 21% to $16.0 million compared to $13.2 million in the corresponding period in the prior year. The increase in operating expenses is primarily attributable to higher share-based compensation, salary, and benefits. Higher share-based compensation expenses are associated with acceleration of expense for certain performance milestones being met in the current quarter. Higher salary and benefits are driven by the expansion of our workforce to support the overall operations, an increase in field resources to expand our market coverage and hiring of an executive at the end of March 2021.

Net loss increased by 58% or $3.5 million to $9.5 million, or $0.38 per share, compared to a net loss of $6.0 million, or $0.26 per share, in the corresponding period of the prior year.

Adjusted EBITDA* loss increased by 42%, or $1.9 million to $6.4 million, over the $4.5 million recognized in the corresponding period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

Calendar Year 2022 Revenue Guidance

Commercial revenues in calendar year 2022 are projected to be approximately $30 million, excluding BARDA revenues, which represents a 20% increase year-over year. We project BARDA revenues of approximately $0.3 million in calendar year 2022, as compared to $7.9 million in calendar year 2021, since we completed delivery of RECELL units into the national stockpile in 2021.

 

*

Adjusted EBITDA is a non-GAAP financial measure. See the appendix to this release for a discussion of Non-GAAP financial measures, including a reconciliation to the most closely correlated GAAP measure.

Webcast and Conference Call Information

The Company will host a conference call to discuss the first quarter financial results after market close on Thursday May 12, 2022, at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time (being 6.30 a.m. Australian Eastern Standard Time on Friday May 13, 2022). The conference call can be accessed live over the phone at (833) 614-1538 for U.S. callers or at (706) 634-6548 international callers, using conference ID:2592487. The live webinar can be accessed at https://ir.avitamedical.com.


Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.

ABOUT AVITA Medical, Inc.

AVITA Medical, Inc. is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical Inc. patented, and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a RES® REGENERATIVE EPIDERMAL SUSPENSION, an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.

AVITA Medicals’ first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is approved for acute partial-thickness thermal burn wounds in patients 18 years of age and older or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients. 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, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 8,000 patients globally, reinforce 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. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings, and precautions.

In February 2022, the FDA reviewed and approved the PMA supplement for RECELL Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow. The RECELL System is a device that enables healthcare professionals to produce a suspension of Spray-On Skin Cells using a small sample of the patient’s own skin for the treatment of acute thermal burns

In international markets, our products are marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds, and aesthetics. The RECELL System is TGA-registered in Australia and received CE-mark approval in Europe.

To learn more, visit www.avitamedical.com.

* Use of Non-GAAP Measure

AVITA Medical’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. AVITA Medical has provided in this release certain financial information that has not been prepared in accordance with GAAP. AVITA Medical’s management believes that the non-GAAP adjusted EBITDA described in the release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding AVITA Medical’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in AVITA Medical’s industry. However, the non-GAAP financial measures that AVITA Medical uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this press release include, but are not limited to, statements concerning, among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational, and financial goals. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions including, but not limited to the ongoing COVID-19 pandemic which are outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this press release. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements

FOR FURTHER INFORMATION:

 

U.S. Media

Sam Brown, Inc.

Christy Curran

Phone +1 615 414 8668

christycurran@sambrown.com

  

Investors

ICR Westwicke

Caroline Corner

Phone +1 415 202 5678

caroline.corner@westwicke.com

O.U.S Media

Monsoon Communications

Rudi Michelson

Phone +61 (0)3 9620 3333

Mobile +61 (0)411 402 737

rudim@monsoon.com.au

  


AVITA MEDICAL, INC.

Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)

 

     As of  
     March 31, 2022     December 31, 2021  

ASSETS

    

Cash and cash equivalents

   $ 23,535     $ 55,511  

Marketable securities

     59,835       29,649  

Accounts receivable, net

     3,481       3,118  

BARDA receivables

     682       308  

Prepaids and other current assets

     1,146       1,213  

Restricted cash

     201       201  

Inventory

     1,803       2,132  
  

 

 

   

 

 

 

Total current assets

     90,683       92,132  

Marketable securities, long-term

     11,684       19,692  

Plant and equipment, net

     1,171       1,262  

Operating lease right-of-use assets

     1,375       1,544  

Intangible assets, net

     416       443  

Other long-term assets

     1,162       942  
  

 

 

   

 

 

 

Total assets

   $ 106,491     $ 116,015  
  

 

 

   

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

    

Accounts payable and accrued liabilities

     2,397       2,708  

Accrued wages and fringe benefits

     2,914       5,363  

Other current liabilities

     1,186       1,075  
  

 

 

   

 

 

 

Total current liabilities

     6,497       9,146  

Contract liabilities

     882       952  

Operating lease liabilities, long-term

     726       918  

Other long-term liabilities

     571       375  
  

 

 

   

 

 

 

Total liabilities

     8,676       11,391  
  

 

 

   

 

 

 

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, no shares issued or outstanding at March 31, 2022 and December 31, 2021

     —         —    

Additional paid-in capital

     335,417       332,484  

Accumulated other comprehensive income

     7,781       8,060  

Accumulated deficit

     (245,386     (235,923
  

 

 

   

 

 

 

Total shareholders’ equity

     97,815       104,624  
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ 106,491     $ 116,015  
  

 

 

   

 

 

 


AVITA MEDICAL, INC.

Consolidated Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

     Three Months Ended March 31,  
     2022     2021  

Revenues

   $ 7,539     $ 8,765  

Cost of sales

     (1,778     (2,146
  

 

 

   

 

 

 

Gross profit

     5,761       6,619  
  

 

 

   

 

 

 

BARDA income

     734       570  

Operating expenses:

    

Sales and marketing expenses *

     (4,828     (3,649

General and administrative expenses *

     (7,534     (5,422

Research and development expenses *

     (3,620     (4,109
  

 

 

   

 

 

 

Total operating expenses

     (15,982     (13,180
  

 

 

   

 

 

 

Operating loss

     (9,487     (5,991

Interest expense

     —         (3

Other income

     28       7  
  

 

 

   

 

 

 

Loss before income taxes

     (9,459     (5,987

Income tax expense

     (4     (10
  

 

 

   

 

 

 

Net loss

   $ (9,463   $ (5,997
  

 

 

   

 

 

 

Net loss per common share:

    

Basic

   $ (0.38   $ (0.26

Diluted

   $ (0.38   $ (0.26

Weighted-average common shares:

    

Basic

     24,937,999       22,734,335  

Diluted

     24,937,999       22,734,335  

 

*

Total operating expenses include impact of share-based compensation as follows:

 

     Three-months ended March 31,  
     2022      2021  

Sales and marketing expenses

   $ 329      $ 238  

General and administrative expenses

     2,327        930  

Research and development expenses

     276        165  
  

 

 

    

 

 

 

Total

   $ 2,932      $ 1,333  
  

 

 

    

 

 

 

Reconciliation of reported Net Loss (GAAP) to Adjusted EBIDTA (NON-GAAP) Measure – Unaudited

 

     Three months ended March 31,  
     2022     2021  

Net Loss

   $ (9,463   $ (5,997

Depreciation expense

     129       137  

Patent Amortization

     34       30  

Share-based expense

     2,932       1,333  

Interest Expense

     —         3  

Income Tax Expense

     4       10  
  

 

 

   

 

 

 

Adjusted EBITDA (Non-GAAP)

   $ (6,364   $ (4,484
  

 

 

   

 

 

 

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Ticker: RCEL
CIK: 1762303
Form Type: 8-K Corporate News
Accession Number: 0001193125-22-152986
Submitted to the SEC: Tue May 17 2022 4:03:16 PM EST
Accepted by the SEC: Tue May 17 2022
Period: Thursday, May 12, 2022
Industry: Surgical And Medical Instruments And Apparatus
Events:
  1. Earnings Release
  2. Financial Exhibit

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