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AVITA Medical Reports Second Quarter 2022 Financial Results

Key Takeaway: AVITA Medical Reports Second Quarter 2022 Financial Results VALENCIA, California, August 11, 2022 and MELBOURNE, Australia, August 12, 2022 AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the Company ), a regenerative medicine company that is developing and commercializing a tech

Full Press Release Details

AVITA Medical Reports Second Quarter 2022 Financial Results
VALENCIA, California, August 11, 2022 and MELBOURNE, Australia, August 12, 2022 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 second quarter ended June 30, 2022.
Second Quarter Highlights and Recent Updates:
Year to date Highlights:
Our commercial team continued to drive further RECELL utilization and penetration within burn centers, and our clinical team
advanced our soft tissue reconstruction and vitiligo trials, said Dr. Mike Perry, AVITA Medical Chief Executive Officer. We look forward to topline data from our vitiligo clinical trial in the second half of this year.
Three Months Ended June 30, 2022 Financial Results
Our commercial revenue, which excludes BARDA revenue, was $8.2 million in the three months ended June 30, 2022, an increase of $1.5 million or
23%, compared to $6.7 million the corresponding period in the prior year. Total revenue, which includes BARDA revenue, was $8.3 million in the second quarter compared to $10.3 million in the corresponding period in the prior year
which included $3.6 million in BARDA related revenue that resulted from our delivery of units to managed inventory for BARDA for emergency response preparedness. The growth in commercial revenues was largely driven by an increase in the number
of customers ordering as well as the average order size for those customers.
Gross profit margin improved by 3% to 83% compared to the corresponding
period in the prior year.
Total operating expenses increased by 3% to $13.9 million compared to $13.4 million in the corresponding period in
the prior year. The increase in operating expenses is primarily attributable to higher compensation costs, sales commissions, and professional fees, partially offset by lower clinical trial related expenses. Higher compensation costs resulted from
an expansion of our commercial team, while higher commissions were driven by an increase in revenues. Higher professional fees are driven by an increase in pre-commercialization activities for RECELL launches
in soft tissue reconstruction and vitiligo. Clinical trial expenses incurred in our soft tissue and vitiligo trials were lower during the period, as the trial participants were in the follow-up phase which is
less costly than the earlier recruitment and treatment phase.
Net loss increased by 33% or $1.5 million to $6.3 million, or $0.25 per share, compared to a net
loss of $4.7 million, or $0.19 per share, in the corresponding period of the prior year.
Adjusted EBITDA* loss increased by 51%, or
$1.6 million to $4.7 million, over the $3.1 million recognized in the corresponding period in the prior year. A table reconciling non-GAAP measures is included in this press release for
Six Months Ended June 30, 2022, Financial Results
Our commercial revenue, which excludes BARDA revenue, was $15.7 million in the six months ended June 30, 2022, an increase of $4.4 million or
39%, compared to $11.3 million in the corresponding period in the prior year. Total revenue, which includes BARDA revenue, was $15.9 million in the current year compared to $19.1 million in the corresponding period in the prior year
which included $7.7 million in BARDA related revenue that resulted from our delivery of units to managed inventory for BARDA for emergency response preparedness. The growth in commercial revenues was largely driven by an increase in the number
of customers ordering as well as the average order size for those customers.
Gross profit margin improved by 2% to 80% compared to the corresponding
period in the prior year.
Total operating expenses increased by 12% to $29.9 million compared to $26.6 million in the corresponding period in
the prior year. The increase in operating expenses is primarily attributable to higher compensation costs and professional fees, partially offset by lower clinical trial related expenses. Higher compensation costs were primarily a result of
increased share-based compensation expenses due to certain performance milestones being met, higher commissions driven by an increase in revenues, and an expansion of our commercial team. Increased professional fees were driven by an increase in pre-commercialization costs for RECELL launches in soft tissue reconstruction and vitiligo. Research and development expenses were lower relative to the prior year during which higher costs were incurred relating to
recruitment and treatment for the soft tissue and vitiligo clinical trials.
Net loss increased by 47% or $5.0 million to $15.7 million, or
$0.63 per share, compared to a net loss of $10.7 million, or $0.45 per share, in the corresponding period of the prior year.
Adjusted EBITDA* loss
increased by 46%, or $3.5 million to $11.1 million, over the $7.6 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.
Conference Call Information
The Company will host a conference call to discuss the second quarter financial results after market close on Thursday
August 11, 2022, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time (being 7.00 a.m. Australian Eastern Standard Time on Friday August 12, 2022). To access the live call via telephone, please register in advance using the link here.
Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call. The live webinar can be accessed at
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. s patented, and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient s own skin. The Company s
lead product is the RECELL System, a device that enables healthcare professionals to Spray-On
Skin Cells using a small sample of the patient s own skin to create an autologous suspension. The RES Regenerative Epidermal
Suspension is then sprayed onto the areas of the patient requiring treatment to regenerate natural healthy epidermis.
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. 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 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 15,000 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 international markets, our products are approved 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, received CE-mark approval in Europe, and received Japan s Pharmaceuticals and
Medical Devices Act (PMDA) approval for burns in Japan.
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 goal. 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 and realization 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 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:
Consolidated Balance Sheets
(In thousands, except share and per share data)
As of
June 30, 2022 December 31, 2021
ASSETS
Cash and cash equivalents $ 34,737 $ 55,511
Marketable securities 49,618 29,649
Accounts receivable, net 3,884 3,118
BARDA receivables 338 308
Prepaids and other current assets 1,005 1,213
Restricted cash 202 201
Inventory 2,022 2,132
Total current assets 91,806 92,132
Marketable securities, long-term 6,743 19,692
Plant and equipment, net 1,249 1,262
Operating lease right-of-use assets 1,203 1,544
Intangible assets, net 428 443
Other long-term assets 1,240 942
Total assets $ 102,669 $ 116,015
LIABILITIES AND SHAREHOLDERS EQUITY
Accounts payable and accrued liabilities 2,495 2,708
Accrued wages and fringe benefits 4,174 5,363
Other current liabilities 1,217 1,075
Total current liabilities 7,886 9,146
Contract liabilities 813 952
Operating lease liabilities, long-term 532 918
Other long-term liabilities 715 375
Total liabilities 9,946 11,391
Non-qualified deferred compensation share awards 163
Contingencies (Note 12)
Shareholders Equity:
Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 25,003,088 and 24,925,743 shares issued and outstanding at June 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 June 30, 2022 and December 31, 2021
Additional paid-in capital 336,668 332,484
Accumulated other comprehensive income 7,536 8,060
Accumulated deficit (251,647 ) (235,923 )
Total shareholders equity 92,560 104,624
Total liabilities and shareholders equity $ 102,669 $ 116,015
Consolidated Statements of Operations
(In thousands, except share and per share data)
Three Months Ended June 30, Six Months Ended June 30,
2022 2021 2022 2021
Revenues $ 8,335 $ 10,304 $ 15,874 $ 19,069
Cost of sales (1,386 ) (2,053 ) (3,164 ) (4,199 )
Gross profit 6,949 8,251 12,710 14,870
BARDA income 551 440 1,285 1,010
Operating expenses:
Sales and marketing expenses* (5,332 ) (4,146 ) (10,160 ) (7,795 )
General and administrative expenses* (5,471 ) (5,275 ) (13,005 ) (10,697 )
Research and development expenses* (3,059 ) (3,974 ) (6,679 ) (8,083 )
Total operating expenses (13,862 ) (13,395 ) (29,844 ) (26,575 )
Operating loss (6,362 ) (4,704 ) (15,849 ) (10,695 )
Interest expense (4 ) (9 ) (4 ) (12 )
Other income 109 2 137 9
Loss before income taxes (6,257 ) (4,711 ) (15,716 ) (10,698 )
Income tax expense (4 ) (7 ) (8 ) (17 )
Net loss $ (6,261 ) $ (4,718 ) $ (15,724 ) $ (10,715 )
Net loss per common share:
Basic $ (0.25 ) $ (0.19 ) $ (0.63 ) $ (0.45 )
Diluted $ (0.25 ) $ (0.19 ) $ (0.63 ) $ (0.45 )
Weighted-average common shares:
Basic 24,971,243 24,860,738 24,954,712 23,803,460
Diluted 24,971,243 24,860,738 24,954,712 23,803,460
* Total operating expenses include impact of share-based compensation as follows:
Three Months Ended June 30, Six Months Ended June 30,
2022 2021 2022 2021
Sales and marketing expenses $ 285 $ 63 $ 614 $ 301
General and administrative expenses 983 1,172 3,310 2,102
Research and development expenses 146 175 422 340
Total 1,414 1,410 4,346 2,743
Reconciliation of reported Net Loss (GAAP) to Adjusted EBIDTA (NON-GAAP) Measure Unaudited
Three Months Ended June 30, Six Months Ended June 30,
2022 2021 2022 2021
Net Loss $ (6,261 ) $ (4,718 ) $ (15,724 ) $ (10,715 )
Depreciation expense 129 145 258 282
Patent Amortization 8 31 42 61
Share-based expense 1,414 1,410 4,346 2,743
Interest Expense 4 9 4 12
Income Tax Expense 4 7 8 17
Adjusted EBITDA (Non-GAAP) $ (4,702 ) $ (3,116 ) $ (11,066 ) $ (7,600 )
Last updated: Aug 11, 2022