AVITA Medical Reports First Quarter 2022 Financial Results
AVITA Medical (RCEL) reported financial results for Q1 2022, showing a significant 61% increase in commercial revenue to $7.4 million compared to Q1 2021. However, total revenue was $7.5 million, down from $8.8 million in the prior year due to a decline in BARDA revenue. The company reported a net loss of $9.5 million, a 58% increase from the previous year's loss. Looking ahead, AVITA expects 2022 commercial revenue of approximately $30 million, a 20% increase year-over-year, despite reduced BARDA revenues.
- 61% increase in commercial revenue to $7.4 million.
- Projected 2022 commercial revenue guidance of approximately $30 million, representing a 20% year-over-year growth.
- Total revenue decreased from $8.8 million to $7.5 million, largely due to a decline in BARDA revenues.
- Net loss increased by 58% to $9.5 million compared to the same period last year.
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 a61% 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
Gross profit margin was
Total operating expenses increased by
Net loss increased by
Adjusted EBITDA* loss increased by
Calendar Year 2022 Revenue Guidance
Commercial revenues in calendar year 2022 are projected to be approximately
*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 O.U.S Media Monsoon Communications Rudi Michelson Phone +61 (0)3 9620 3333 Mobile +61 (0)411 402 737 rudim@monsoon.com.au | Investors ICR Westwicke Caroline Corner Phone +1 415 202 5678 caroline.corner@westwicke.com |
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, and 24,925,743 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 3 | 3 | ||||||
| Preferred stock, 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 | ) | |
FAQ
What were AVITA Medical's Q1 2022 financial results?
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