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AVITA Medical Reports Third Quarter Financial Results

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AVITA Medical (NASDAQ: RCEL) reported strong Q3 2024 results with commercial revenue of $19.5 million, up 44% year-over-year. The company achieved a gross profit margin of 83.7%. Key developments include a distribution agreement with Regenity Biosciences for Cohealyx™ and an amended credit agreement with OrbiMed. The company expects Q4 2024 revenue between $22.3-24.3 million and maintains full-year guidance of $68.0-70.0 million. However, net loss widened to $16.2 million ($0.62 per share) compared to $8.7 million ($0.34 per share) in Q3 2023, with operating expenses increasing to $30.2 million.

AVITA Medical (NASDAQ: RCEL) ha riportato risultati solidi per il terzo trimestre del 2024 con entrate commerciali di 19,5 milioni di dollari, in aumento del 44% rispetto all'anno precedente. L'azienda ha raggiunto un margine di profitto lordo del 83,7%. Tra gli sviluppi chiave c'è un accordo di distribuzione con Regenity Biosciences per Cohealyx™ e un accordo di credito modificato con OrbiMed. L'azienda prevede che le entrate del quarto trimestre 2024 siano comprese tra 22,3 e 24,3 milioni di dollari e mantiene una guida annuale compresa tra 68,0 e 70,0 milioni di dollari. Tuttavia, la perdita netta è aumentata a 16,2 milioni di dollari (0,62 dollari per azione) rispetto agli 8,7 milioni di dollari (0,34 dollari per azione) del terzo trimestre del 2023, con spese operative in aumento a 30,2 milioni di dollari.

AVITA Medical (NASDAQ: RCEL) reportó resultados sólidos para el tercer trimestre de 2024 con ingresos comerciales de 19.5 millones de dólares, un aumento del 44% interanual. La compañía logró un margen de utilidad bruta del 83.7%. Entre los desarrollos clave se incluye un acuerdo de distribución con Regenity Biosciences para Cohealyx™ y un acuerdo de crédito modificado con OrbiMed. La empresa espera ingresos para el cuarto trimestre de 2024 entre 22.3 y 24.3 millones de dólares y mantiene las proyecciones anuales entre 68.0 y 70.0 millones de dólares. Sin embargo, la pérdida neta se amplió a 16.2 millones de dólares (0.62 dólares por acción) en comparación con 8.7 millones de dólares (0.34 dólares por acción) en el tercer trimestre de 2023, con gastos operativos en aumento a 30.2 millones de dólares.

AVITA Medical (NASDAQ: RCEL)는 2024년 3분기 강력한 실적을 발표했으며, 상업 수익이 1,950만 달러로 전년 대비 44% 증가했습니다. 회사는 총 이익률이 83.7%에 도달했습니다. 주요 개발사항으로 Regenity Biosciences와 Cohealyx™에 대한 유통 계약과 OrbiMed와의 수정된 신용 계약이 있습니다. 회사는 2024년 4분기 수익이 2,230만에서 2,430만 달러 사이일 것으로 예상하며, 연간 지침을 6,800만에서 7,000만 달러로 유지합니다. 그러나 순손실은 1,620만 달러(주당 0.62달러)로 확대되었으며, 이는 2023년 3분기의 870만 달러(주당 0.34달러)에 비해 증가한 수치이며, 운영 비용은 3,020만 달러로 증가했습니다.

AVITA Medical (NASDAQ: RCEL) a annoncé de bons résultats pour le troisième trimestre 2024 avec des revenus commerciaux de 19,5 millions de dollars, en hausse de 44 % par rapport à l'année précédente. La société a atteint une marge brute de 83,7 %. Parmi les développements clés figure un accord de distribution avec Regenity Biosciences pour Cohealyx™ et un amendement à l'accord de crédit avec OrbiMed. L'entreprise prévoit des revenus allant de 22,3 à 24,3 millions de dollars pour le quatrième trimestre 2024 et maintient ses prévisions annuelles à 68,0-70,0 millions de dollars. Cependant, la perte nette a augmenté pour atteindre 16,2 millions de dollars (0,62 dollar par action) contre 8,7 millions de dollars (0,34 dollar par action) au troisième trimestre 2023, les dépenses d'exploitation ayant augmenté à 30,2 millions de dollars.

AVITA Medical (NASDAQ: RCEL) berichtete über starke Ergebnisse im 3. Quartal 2024 mit Vertriebserlösen von 19,5 Millionen Dollar, was einem Anstieg von 44 % im Vergleich zum Vorjahr entspricht. Das Unternehmen erreichte eine Bruttogewinnspanne von 83,7 %. Zu den wichtigen Entwicklungen gehört ein Vertriebsvertrag mit Regenity Biosciences für Cohealyx™ sowie ein geänderter Kreditvertrag mit OrbiMed. Das Unternehmen erwartet im 4. Quartal 2024 Umsätze zwischen 22,3 und 24,3 Millionen Dollar und hält die Prognose für das gesamte Jahr bei 68,0 bis 70,0 Millionen Dollar. Die Nettoverluste weiteten sich jedoch auf 16,2 Millionen Dollar (0,62 Dollar pro Aktie) aus, verglichen mit 8,7 Millionen Dollar (0,34 Dollar pro Aktie) im 3. Quartal 2023, während die Betriebsausgaben auf 30,2 Millionen Dollar anstiegen.

Positive
  • Commercial revenue increased 44% YoY to $19.5 million
  • Strong gross profit margin of 83.7%
  • Q4 2024 revenue guidance projects 58-72% growth
  • 75% of revenue base transitioned to RECELL GO
  • Secured exclusive distribution rights for Cohealyx™
Negative
  • Net loss widened to $16.2 million from $8.7 million YoY
  • Operating expenses increased to $30.2 million from $21.1 million YoY
  • Interest expense increased by $1.3 million YoY
  • BARDA income decreased to zero from $0.2 million YoY
  • Forfeited access to $50 million in potential funding through OrbiMed agreement

Insights

AVITA Medical delivered strong Q3 2024 results with $19.5M in commercial revenue, up 44% year-over-year, driven by RECELL GO adoption. The 83.7% gross margin remains robust despite slight compression from product validation costs. Key positives include accelerating growth trajectory with Q4 guidance of $22.3-24.3M suggesting continued momentum and strategic debt covenant amendment providing operational flexibility.

However, operating expenses increased significantly to $30.2M, up $9.1M year-over-year, leading to a wider net loss of $16.2M. While the increased spend supports commercial expansion, the path to projected profitability by Q3 2025 requires careful execution. Cash position of $44.4M provides reasonable runway given current burn rate.

The successful transition of 75% of revenue to RECELL GO demonstrates strong market acceptance of the improved delivery system. The upcoming RECELL GO mini approval and Cohealyx launch in 2025 will expand the addressable market across the wound care continuum. The exclusive distribution rights for Cohealyx, a collagen-based dermal matrix, strategically complements the existing portfolio and should drive incremental growth.

The planned post-market study for Cohealyx in Q1 2025 will be important for clinical validation and market adoption. The company's focus on establishing RECELL as standard of care through expanded commercial reach and medical science liaison team shows commitment to market leadership in regenerative wound care.

VALENCIA, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today reported financial results for the third quarter ended September 30, 2024.

Financial Results and Recent Business Updates

  • Commercial revenue of $19.5 million, an increase of approximately 44% compared to the same period in 2023
  • Gross profit margin of 83.7%
  • On July 31, 2024, entered into a multi-year development and distribution agreement with Regenity Biosciences that provides AVITA Medical with the exclusive rights to market, sell, and distribute Cohealyx, an AVITA Medical branded collagen-based dermal matrix
  • On November 7, 2024, amended the credit agreement with OrbiMed in a mutually beneficial arrangement, forgoing access to an additional $50 million in funding in exchange for removal of the 12-month trailing revenue covenant for the period ending December 31, 2024

“Third-quarter commercial revenue surpassed our second-quarter record by 29%, underscoring the strength of RECELL GO as a transformative product and the success of adoption," said Jim Corbett, Chief Executive Officer of AVITA Medical. "With over 75% of our revenue base now transitioned to RECELL GO and the anticipated launch of Cohealyx in 2025, we are positioned to address a broad continuum of wound care needs. We remain committed to establishing RECELL as the standard of care and transforming wound care, all while advancing our mission to improve patient outcomes and expand access."

Future Milestones

  • Anticipate FDA approval of RECELL GO mini by December 31, 2024
  • Anticipate 510(k) clearance of Cohealyx before year-end; expect to launch in January 2025
  • Anticipate initiating post-market clinical study to validate the preclinical work of Cohealyx in Q1 2025

Financial Guidance

  • Commercial revenue for the fourth quarter 2024 is expected to be in the range of $22.3 to $24.3 million, reflecting growth of approximately 58% to 72% over the same period in 2023
  • Commercial revenue for the full-year 2024 is expected to be within the previously provided revenue guidance of $68.0 to $70.0 million, reflecting growth of approximately 37% to 41% over the full-year 2023
  • Confirming previously given guidance of achieving cashflow break-even and GAAP profitability no later than the end of Q3 2025

Third Quarter 2024 Financial Results

Commercial revenue was $19.5 million in the three-months ended September 30, 2024, an increase of $5.9 million, or 43.8%, compared to $13.6 million in the corresponding period in the prior year. The growth in commercial revenue was largely driven by accelerating the transition to RECELL GO, as well as deeper penetration within existing customer accounts and new accounts for full-thickness skin defects.

Gross profit margin was 83.7% compared to 84.5% in the corresponding period in the prior year. The decrease was due to ongoing engineering and validation of the RECELL GO durable and disposable cartridge.

BARDA income decreased to zero, compared to $0.2 million in the corresponding period in the prior year, due to the ending of reimbursable clinical trials. BARDA income in the prior year 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.

Total operating expenses for the quarter were $30.2 million, compared to $21.1 million in the same period in 2023. The increase in operating expenses is primarily attributable to an increase of $4.6 million in sales and marketing expenses due to employee-related costs, including salaries and benefits, commissions, professional fees, and travel expenses, collectively, as a result of the expansion of the Company's commercial organization to support its growing commercial operations. G&A expenses increased by $3.5 million as a result of higher salaries and benefits, severance benefits, deferred compensation expenses, and professional fees, partially offset by lower other corporate expenses. In addition, the increase in operating expenses included an increase of $1.0 million in R&D costs, which was primarily due to employee compensation costs related to the Company's expanded team of medical science liaisons.

Interest expense increased approximately $1.3 million in comparison to the same period in the prior year due to the interest expense related to the long-term debt incurred as part of the OrbiMed Credit Agreement, for a principal amount owed of $40.0 million.

Other (expense) income, net decreased by $1.7 million to an expense of $1.1 million from income of $0.6 million in the prior period. In the current period, other (expense) income consists of non-cash charges of $1.0 million and $0.8 million related to the changes in fair value of the debt and warrant liability, respectively, offset by $0.6 million in income related to the Company's investments. The prior period income consisted of $0.7 million related to our investments offset by $0.1 million in other losses, net.

Net loss was $16.2 million, or a loss of $0.62 per basic and diluted share, compared to a net loss of $8.7 million, or a loss of $0.34 per basic and diluted share, in the same period in 2023.

As of September 30, 2024, the Company had approximately $44.4 million in cash, cash equivalents, and marketable securities.

Webcast and Conference Call Information

AVITA Medical will host a conference call on Thursday, November 7, 2024, at 1:30 p.m. Pacific Time (Friday, November 8, 2024, at 8:30 a.m. Australian Eastern Daylight Time) to discuss its third quarter 2024 financial results and recent business highlights. The live webcast will be accessible under the Events & Presentations section of the AVITA Medical website at ir.avitamedical.com. To participate by telephone, please register in advance to receive dial-in details and a personal PIN at https://register.vevent.com/register/BI5bf899d9f4574896abaf08308299cbdf. A replay of the webcast will be available shortly after the live event.

About AVITA Medical, Inc.
AVITA Medical® is a commercial-stage regenerative medicine company transforming the standard of care in wound care management and skin restoration with innovative devices. At the forefront of our platform is the RECELL® System, approved by the U.S. Food and Drug Administration for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin Cells, delivering a transformative solution at the point-of-care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. In the United States, AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm®, a biosynthetic wound matrix, and Cohealyx, an AVITA Medical-branded collagen-based dermal matrix.

In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns, full-thickness skin defects, and vitiligo. The RECELL System is TGA-registered in Australia, has received CE mark approval in Europe, and has PMDA approval in Japan.

To learn more, visit www.avitamedical.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements generally may be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “would,” “may,” “will,” “believe,” “continue,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “outlook,” “guidance,” “future,” and similar words or expressions, and the use of future dates. Forward-looking statements include, but are not limited to, statements relating to 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, as well as other economic or political conditions outside of the Company’s control. These statements are made as of the date of this release, and the Company undertakes no obligation to publicly update or revise any of these statements, except as required by law. For additional information and other important factors that may cause actual results to differ materially from forward-looking statements, please see the “Risk Factors” section of the Company’s latest Annual Report on Form 10-K and other publicly available filings for a discussion of these and other risks and uncertainties.

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


AVITA MEDICAL, INC.
Consolidated Balance Sheets
(In thousands, except share and per share data)
 
  As of 
  September 30, 2024  December 31, 2023 
ASSETS      
Cash and cash equivalents $18,639  $22,118 
Marketable securities  25,766   66,939 
Accounts receivable, net  10,288   7,664 
BARDA receivables  111   30 
Prepaids and other current assets  2,892   1,659 
Inventory  6,229   5,596 
Total current assets  63,925   104,006 
Plant and equipment, net  9,151   1,877 
Operating lease right-of-use assets  3,780   2,440 
Corporate-owned life insurance ("COLI") asset  3,059   2,475 
Intangible assets, net  590   487 
Other long-term assets  546   355 
Total assets $81,051  $111,640 
LIABILITIES, NON-QUALIFIED DEFERRED COMPENSATION PLAN SHARE AWARDS AND STOCKHOLDERS' EQUITY      
Accounts payable and accrued liabilities $4,187  $3,793 
Accrued wages and fringe benefits  9,776   7,972 
Current non-qualified deferred compensation ("NQDC") liability  1,870   168 
Other current liabilities  1,308   1,266 
Total current liabilities  17,141   13,199 
Long-term debt  42,547   39,812 
Non-qualified deferred compensation liability  2,742   3,663 
Contract liabilities  332   357 
Operating lease liabilities, long term  3,079   1,702 
Warrant liability  2,759   3,158 
Total liabilities  68,600   61,891 
Non-qualified deferred compensation plan share awards  224   693 
Commitments and contingencies (Note 11)      
Stockholders' equity:      
Common stock, $0.0001 par value per share, 200,000,000 shares authorized, 26,217,629 and 25,682,078, shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively  3   3 
Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized, no shares issued or outstanding at September 30, 2024 and December 31, 2023  -   - 
Company common stock held by the non-qualified deferred compensation plan  (1,255)  (1,130)
Additional paid-in capital  363,769   350,039 
Accumulated other comprehensive loss  (2,065)  (1,887)
Accumulated deficit  (348,225)  (297,969)
Total stockholders' equity  12,227   49,056 
Total liabilities, non-qualified deferred compensation plan share awards and stockholders' equity $81,051  $111,640 
       


AVITA MEDICAL, INC.
Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
 
  Three-Months Ended Nine-Months Ended 
  September 30, 2024 September 30, 2023 September 30, 2024 September 30, 2023 
          
Sales revenue $19,394 $13,645 $45,681 $35,948 
Lease revenue  152  -  164  - 
Total revenues  19,546  13,645  45,845  35,948 
Cost of sales  (3,190) (2,113) (6,814) (5,984)
Gross profit  16,356  11,532  39,031  29,964 
BARDA income  -  212  -  1,369 
Operating expenses:         
Sales and marketing  (15,144) (10,532) (44,086) (27,075)
General and administrative  (9,590) (6,124) (26,071) (20,584)
Research and development  (5,428) (4,394) (15,510) (14,056)
Total operating expenses  (30,162) (21,050) (85,667) (61,715)
Operating loss  (13,806) (9,306) (46,636) (30,382)
Interest expense  (1,359) (10) (4,063) (21)
Other (expense) income, net  (1,068) 615  478  2,141 
Loss before income taxes  (16,233) (8,701) (50,221) (28,262)
Income tax benefit (expense)  28  (11) (35) (54)
Net loss $(16,205)$(8,712)$(50,256)$(28,316)
Net loss per common share:         
Basic and diluted $(0.62)$(0.34)$(1.95)$(1.12)
Weighted-average common shares:         
Basic and diluted  25,983,929  25,401,754  25,794,690  25,281,920 

FAQ

What was AVITA Medical's (RCEL) revenue growth in Q3 2024?

AVITA Medical's commercial revenue grew 44% year-over-year to $19.5 million in Q3 2024.

What is AVITA Medical's (RCEL) revenue guidance for Q4 2024?

AVITA Medical expects Q4 2024 commercial revenue to be between $22.3 and $24.3 million, representing 58-72% growth over Q4 2023.

When does AVITA Medical (RCEL) expect to achieve profitability?

AVITA Medical expects to achieve cashflow break-even and GAAP profitability no later than the end of Q3 2025.

What was AVITA Medical's (RCEL) net loss in Q3 2024?

AVITA Medical reported a net loss of $16.2 million, or $0.62 per share, in Q3 2024.

Avita Medical, Inc.

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