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CLOSED · 01:50 ET
Market ClerkRecap
Sat Sep 26 · markets closed4 signals on Sep 25151 insider buys this week · $292.9MCIRO short report next: Sep 29The week ahead

RCEL

AVITA Medical, Inc.
NASDAQ · HEALTH CARE · SURGICAL & MEDICAL INSTRUMENTS & APPARATUS
11.84
+0.26 +2.25%
USD · close Sep 25
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Work order
34
FLAG · shorts 34
Insiders, 90 days
0
no open-market filings in 90 days
Congress, 90 days
0 / 0
no disclosures naming it
Big money
0 / 15
none of the tracked funds disclose it
Calls on record
0
nobody we score has called it yet
MKT CAP $366.2MP/E —DIV YIELD —FCF YIELD -6.72%REV TTM $75.6M +1.0%NET INCOME −$43.1MNET DEBT $37.5M52W 3.27 – 11.84SEC XBRL · TTM TO Invalid Date

How RCEL rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
34%
of sentences unchanged
Added
766
new sentences
Dropped
766
sentences removed
Length
+664
words, now 55,174

New in FY2025

  • Although we have begun full scale marketing and sales of our products in the United States and other jurisdictions, we have not yet achieved profitability.
  • We had a total net loss of $48.6 million and $61.8 million for the year ended December 31, 2025 and 2024, respectively.
  • We have incurred a cumulative deficit of $408.4 million through December 31, 2025.
  • We anticipate that we may continue to incur losses at least until sales of our products are adequate to fund operating expenses.
  • We had previously entered into a credit agreement with OrbiMed Advisors, LLC (as amended, the “Previous Credit Agreement”) on October 18, 2023, most recently amended in the Previous Credit Agreement’s Sixth Amendment, on November 5, 2025 (the “Sixth Amendment”) and incurred $40.0 million of indebtedness secured by substantially all of our assets.
  • On January 13, 2026, we entered into a new Credit Agreement and Guaranty (the “Perceptive Credit Agreement”), and Security Agreement (the “Security Agreement”), by and among us, as borrower, Avita Medical Americas, LLC, a wholly-owned subsidiary of the Company, as guarantor (the “Guarantor,” taken together with the Company, the “Obligors”) and Perceptive Credit Holdings V, LP as a lender and the administrative agent (the “Lender,” and the “Administrative Agent,” as applicable).
  • The Perceptive Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $60 million (the “Loan Facility”), of which (i) $50 million was funded on the Closing Date (the “Initial Commitment Amount”) and (ii) $10 million will be made available, at our discretion by notice to the Administrative Agent on or before March 31, 2027, subject to satisfaction of a certain net revenue requirement (the “Additional Commitment Amount”).
  • On the Closing Date, we closed on the Initial Commitment Amount, less certain fees and expenses payable to or on behalf of the Lender.
  • Simultaneously with the closing of the Initial Commitment Amount, we repaid in full and terminated all of obligations and commitments (other than previously issued warrants) (the “Refinancing Transaction”) [1] under the Previous Credit Agreement.
  • In addition, if the Company’s net revenue does not equal or exceed a certain amount for upcoming fiscal periods as set forth in the Perceptive Credit Agreement, then the Company will be in default of the Perceptive Credit Agreement. _________________________________ [1] Additional details concerning the Perceptive Credit Agreement, the Security Agreement, and the Refinancing Transaction are provided in Item 7, infra.
  • If we are unable to generate sufficient cash flow to satisfy payment obligations under the Perceptive Credit Agreement, we may be required to adopt one or more alternatives, such as obtaining additional equity capital on terms that may be onerous or highly dilutive.
  • The restrictions and covenants in the Perceptive Credit Agreement may also prevent us from taking actions that we believe would be in the best interests of our business, and may make it difficult for us to successfully execute our business strategy or effectively compete with companies that are not similarly restricted.
  • And any breach by the Company of covenants and restrictions in such agreements could result in a default under the Perceptive Credit Agreement, which could result in an acceleration of the repayment of our indebtedness.
  • We may require additional financing in the future to continue the development and commercialization of our current and future products, which may cause dilution to our existing stockholders.
  • If we are unable to achieve profitability sufficient to permit us to fund our operations, repay indebtedness in accordance with the Perceptive Credit Agreement, and take other planned actions, we may be required to raise additional capital.
  • As a result, we may not achieve the expected clinical milestones necessary for approval by the FDA, or other regulators, for the use of our products for additional applications or indications in the United States or other countries.
  • Events that may prevent successful or timely commencement, enrollment or completion of a clinical study or a regulatory application include: • delays in raising, or inability to raise, sufficient capital to fund the planned trials; • delays in reaching a consensus with regulatory agencies on trial design; • changes in trial design; • inability to identify, recruit, and train suitable clinical investigators; • inability to add new clinical trial sites; • delays in reaching agreement on acceptable terms for the performance of the trials with prospective clinical research organizations and clinical trial sites; • delays in recruiting suitable clinical sites and patients (i.e., subjects) to participate in clinical trials; • imposition of a clinical hold by regulatory agencies for any reason, including negative clinical results, safety concerns or as a result of an inspection of manufacturing or clinical operations or trial sites; • failure by any relevant parties to adhere to clinical trial requirements; • failure to perform in accordance with the FDA’s Good Clinical Practice (“GCPs”), or applicable regulatory guidelines in other countries; • delays in the testing, validation, manufacturing, and delivery to the clinical sites of the product candidates; • delays caused by clinical trial sites not completing a trial; • failure to demonstrate adequate effectiveness; • occurrence of serious adverse events in clinical trials associated with the product candidates that are viewed to outweigh its potential benefits; • changes in regulatory requirements or guidance that require amending or submitting new clinical protocols; • adverse events, safety issues, product recalls, manufacturing or supply chain interruptions, or poor clinical outcomes where RECELL is being used commercially; and • disagreements with regulatory agencies in the interpretation of the data from our clinical trials.
  • If we are not able to successfully complete clinical trials or are not able to do so in a timely and cost-effective manner, we will not be able to obtain regulatory approval for the use of our products for additional applications or indications, all of which could have a material adverse effect on our business, financial condition, or results of operations.
  • We may require additional clinical data or approvals from regulatory authorities within the jurisdictions in which we operate to market improved versions of RECELL for the same or additional indications, and from any other jurisdictions in which we seek to market the product.
  • This PMA allows us to sell RECELL and RECELL GO in the United States, our current primary market.
  • For example, even though the FDA has granted marketing approval for use of RECELL in the treatment of full-thickness skin defects and vitiligo, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing, and promotion of the product in those jurisdictions if not currently approved.
  • In addition, process deviations or unanticipated effects of approved process changes may result in production runs of our products not complying with stability requirements or specifications.
  • We have a manufacturing facility located in Ventura, California where we produce, package, and warehouse RECELL and PermeaDerm.
  • We also rely on global third-party manufacturers for production of some of the components used in RECELL.
  • We collect and store sensitive business and other information, such as sensitive intellectual property, on our IT systems.
  • Our business operations are dependent upon the secure maintenance of these IT systems and this information.
  • We face risks related to the disruption of the confidentiality, integrity, and availability of our IT systems and the information that we maintain—or engage a third-party to maintain on our behalf—including unauthorized access, acquisition, use, disclosure, or modification of such information.
  • In addition, any security breach or attempt thereof could result in liability for stolen assets or information, additional costs associated with repairing any system damage, and implementation of measures to prevent future breaches, including organizational changes, deployment of additional personnel and protection technologies, increased employee training, and engagement of third-party experts and consultants.
  • We cannot guarantee that any costs and liabilities incurred in relation to an attack or incident will be covered by our existing insurance policies or that applicable insurance will be available to us in the future on economically reasonable terms or at all.
  • In addition, we cannot assure that any of our third-party service providers with access to our sensitive or confidential information, or to that of our customers and/or employees, will not experience security breaches or attempts thereof, which could have a corresponding effect on our business.
  • Tariffs and Changes in Trade Policy Could Adversely Affect Our Business, Financial Condition, and Results of Operations We currently derive less than 5% of our net sales from international operations and a de minimus portion of our raw materials and components are sourced internationally.
  • The sale and shipment of our products across international borders, as well as the purchase of materials and components from international sources, subject us to U.S. and foreign governmental trade regulations, including those related to duties, and tariffs.
  • Recent shifts in U.S. trade policy and the imposition of tariffs on imports from certain countries, as well as retaliatory tariffs imposed by those countries on U.S. goods, may negatively impact our business, results of operations, and financial condition.
  • We cannot predict the future direction of trade policy or the impact of any future trade restrictions or retaliatory measures that may further impact our business.
  • The medical device, biotechnology and pharmaceutical industries, specifically relating to the areas where we currently or intend to market our products, are intensely competitive and subject to significant changes due to technology and medical practice standards.
  • Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products, treatments or procedures that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than our current products or any future products we develop.
  • These companies compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies necessary for, or complementary to, our products.
  • Further, the validity and enforceability of our patent portfolio cannot be predicted with certainty.
  • We rely on patents to protect a significant part of our intellectual property and to enhance our competitive position.
  • Furthermore, our issued patents may not be broad enough to prevent competitors from producing products similar to ours, and we have products that we continue to commercialize that were covered by patents that are now expired.

and 726 more.

Gone since FY2024

  • Although we have begun full scale marketing and sales of our RECELL ® System in the United States and other jurisdictions, we have not yet achieved profitability.
  • We had a total net loss of $61.8 million and $35.4 million for the year ended December 31, 2024 and December 31, 2023, respectively.
  • We have incurred a cumulative deficit of $359.8 million through December 31, 2024.
  • We anticipate that we may continue to incur losses at least until sales of the RECELL System are adequate to fund operating expenses.
  • Pursuant to the Credit Agreement that we entered with OrbiMed Advisors, LLC (as amended, the “Credit Agreement”) on October 18, 2023, most recently amended in the Credit Agreement’s Third Amendment, on November 7, 2024 (the “Third Amendment”), we incurred $40.0 million of indebtedness secured by substantially all of our assets.
  • In addition, if the Company’s net revenue does not equal or exceed a certain amount for upcoming fiscal periods as set forth in the Credit Agreement, then the Company will be required to repay 5% of the outstanding principal amount of its indebtedness (along with interest accrued on that principal amount if not already paid) in equal quarterly installments, in addition to paying both a repayment fee and a prepayment fee with each quarterly installment.
  • If we are unable to generate sufficient cash flow to satisfy payment obligations under the Credit Agreement, we may be required to adopt one or more alternatives, such as obtaining additional equity capital on terms that may be onerous or highly dilutive.
  • The restrictions and covenants in the Credit Agreement may also prevent us from taking actions that we believe would be in the best interests of our business, and may make it difficult for us to successfully execute our business strategy or effectively compete with companies that are not similarly restricted.
  • And any breach by the Company of covenants and restrictions in such agreements could result in a default under the Credit Agreement, which could result in an acceleration of the repayment of our indebtedness.
  • We may require additional financing in the future to continue the development and commercialization of our RECELL System or any future products, which may cause dilution to our existing stockholders.
  • If we are unable to achieve profitability sufficient to permit us to fund our operations, repay indebtedness in accordance with the Credit Agreement, and take other planned actions, we may be required to raise additional capital.
  • We may be unsuccessful in commercializing our RECELL System or other future products due to unfavorable pricing regulations or third-party coverage or reimbursement policies.
  • And pricing negotiations can take considerable time after the receipt of marketing approval for a medical product.
  • Further, such pricing limitations may hinder our ability to recoup our total investment in our RECELL System or other future products.
  • If we are unable to promptly obtain coverage and profitable payment rates from hospital budgets, as well as from either government-funded or private purchasers, for the RECELL System or any future products, this could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products, and our overall financial condition.
  • For example, we presently benefit from various reimbursement codes, including the following: • Medicare Severity Diagnosis-Related Groups (“MS-DRGs”), for hospitals with inpatient services. • Specific International Classification of Disease, 10th revision, Procedure Classification System (“ICD-10-PCS”) code series describing our “cell suspension technique” for the use of the RECELL System. • CPT codes that describe “skin cell suspension autograft to support physician reimbursement by professional healthcare services and for facility services at ambulatory surgical centers (“ASCs”), and Ambulatory Payment Classifications (“APCs”) for hospital reimbursement for outpatient department services.
  • There can be no guarantee that the above reimbursement codes will not be withdrawn, reduced, consolidated or otherwise altered in a manner which is not supportive of ongoing commercial use of the RECELL System.
  • As a result, we may not achieve the expected clinical milestones necessary for approval by the FDA, or other regulators, for the use of our RECELL System for additional applications in the United States or other countries.
  • Events that may prevent successful or timely commencement, enrollment or completion of a clinical study or a regulatory application include: • delays in raising, or inability to raise, sufficient capital to fund the planned trials; • delays in reaching a consensus with regulatory agencies on trial design; • changes in trial design; • inability to identify, recruit, and train suitable clinical investigators; • inability to add new clinical trial sites; • delays in reaching agreement on acceptable terms for the performance of the trials with prospective clinical research organizations and clinical trial sites; • delays in recruiting suitable clinical sites and patients (i.e., subjects) to participate in clinical trials; • imposition of a clinical hold by regulatory agencies for any reason, including negative clinical results, safety concerns or as a result of an inspection of manufacturing or clinical operations or trial sites; • failure by any relevant parties to adhere to clinical trial requirements; • failure to perform in accordance with the FDA’s Good Clinical Practice (“GCPs”), or applicable regulatory guidelines in other countries; • delays in the testing, validation, manufacturing, and delivery to the clinical sites of the product candidates; • delays caused by clinical trial sites not completing a trial; • failure to demonstrate adequate effectiveness; • occurrence of serious adverse events in clinical trials associated with the product candidates that are viewed to outweigh its potential benefits; • changes in regulatory requirements or guidance that require amending or submitting new clinical protocols; • adverse events, safety issues, product recalls, manufacturing or supply chain interruptions, or poor clinical outcomes where the RECELL System is being used commercially; and • disagreements with regulatory agencies in the interpretation of the data from our clinical trials.
  • If we are not able to successfully complete clinical trials or are not able to do so in a timely and cost-effective manner, we will not be able to obtain regulatory approval for the use of our RECELL System for additional applications, all of which could have a material adverse effect on our business, financial condition, or results of operations.
  • For instance, the first generation of RECELL has been approved by regulatory authorities in Australia and the EU for use in the treatment of burns and acute wounds, and by regulatory authorities in Japan for use in certain treatments of burns.
  • However, we will require additional clinical data or approvals from regulatory authorities within these jurisdictions to market improved versions of RECELL for the same or additional indications, and from any other jurisdictions in which we seek to market the product.
  • This PMA allows us to sell our RECELL and RECELL GO in the United States, our current primary market.
  • For example, even though the FDA has granted marketing approval for use of our RECELL System for the treatment of full-thickness skin defects and vitiligo, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing, and promotion of the product in those jurisdictions if not currently approved.
  • In addition, process deviations or unanticipated effects of approved process changes may result in production runs of our RECELL System not complying with stability requirements or specifications.
  • We have a manufacturing facility located in Ventura, California where we produce, package, and warehouse the RECELL System.
  • We also rely on global third-party manufacturers for production of some of the components used in the RECELL System.
  • We collect and store sensitive business and other information, including intellectual property and trade secrets, on our networks.
  • Our business operations are dependent upon the secure maintenance of this information.
  • We face risks related to the protection of information that we maintain—or engage a third-party to maintain on our behalf—including unauthorized access, acquisition, use, disclosure, or modification of such information.
  • In addition, any security breach or attempt thereof could result in liability for stolen assets or information, additional costs associated with repairing any system damage, incentives offered to clients or other business partners to maintain business relationships after a breach, and implementation of measures to prevent future breaches, including organizational changes, deployment of additional personnel and protection technologies, increased employee training, and engagement of third-party experts and consultants.
  • In addition, we cannot assure you that any of our third-party service providers with access to our sensitive or confidential information, or to that of our customers and/or employees, will not experience security breaches or attempts thereof, which could have a corresponding effect on our business.
  • The medical device, biotechnology and pharmaceutical industries, specifically relating to the areas where we currently or intend to market our RECELL System, are intensely competitive and subject to significant changes due to technology and medical practice standards.
  • Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products, treatments or procedures that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than our RECELL System or any future products we develop.
  • These companies compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies necessary for, or complementary to, our programs.
  • Further, the validity and enforceability of our patent portfolio cannot be predicated with certainty.
  • We will rely on patents to protect a significant part of our intellectual property and to enhance our competitive position.
  • Furthermore, the patent protections we have been granted may not be broad enough to prevent competitors from producing products similar to ours.
  • Filing, prosecuting and defending patents on all of our technologies and products in every jurisdiction is expensive.
  • These products may compete with our products and may not be covered by any patent claims or other intellectual property rights.

and 726 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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