Full Press Release Details
AVITA Medical Reports First Quarter 2022 Financial Results
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:
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
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.
Webcast and Conference Call Information
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 |
Consolidated Balance Sheets
(In thousands, except share and per share data)
| 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 |
Consolidated Statements of Operations
(In thousands, except share and per share data)
| 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 |
| 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 | ) |