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AVITA Medical (RCEL) revises PermeaDerm pact with new fees, targets and territories

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

AVITA Medical, Inc. entered into a Global Amendment with Stedical Scientific, Inc. on August 5, 2026, modifying their distribution and manufacturing arrangements for PermeaDerm. AVITA will pay a $500,000 fee for a right of first offer and refusal to expand its exclusive distribution territory to all or part of the European Union, the United Kingdom, and/or Australia.

AVITA’s revenue share from PermeaDerm sales will rise to 67% for sheet products, with higher sharing if AVITA’s gross margin exceeds 50%, and to 80% for glove products, with higher sharing if gross margin exceeds 35%. For 2026, AVITA must achieve total PermeaDerm revenue sharing payments of $1.0 million, with 20% minimum annual growth in such payments through 2030, while all prior minimum revenue sharing requirements are waived.

Stedical may commercialize PermeaDerm in certain U.S. markets not served by AVITA, purchasing product at a 10% premium to AVITA’s actual manufacturing costs. For PermeaDerm sold by Stedical outside the U.S., primarily in Asia, AVITA will charge $200 per carton plus a 10% manufacturing fee, subject to a reasonable volume cap.

Positive

  • None.

Negative

  • None.
Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Right of first offer fee $500,000 Fee paid for right of first offer and refusal on expanded territories
Sheet product revenue share 67% AVITA share of PermeaDerm revenue for sheet-form products
Glove product revenue share 80% AVITA share of PermeaDerm revenue for glove-form products
2026 revenue sharing target $1.0 million Total PermeaDerm revenue sharing payments required for 2026
Annual growth minimum 20% Minimum annual growth in PermeaDerm revenue sharing payments through 2030
Ex-U.S. carton price $200 per carton Base price for PermeaDerm sold to Stedical for markets outside the U.S.
Manufacturing fee rate 10% Manufacturing fee added to PermeaDerm sold to Stedical outside the U.S.
Global Amendment regulatory
"entered into a Global Amendment of their existing distribution agreement"
right of first offer and refusal financial
"will hold the right of first offer and refusal to expand its exclusive"
exclusive distribution territory financial
"to expand its exclusive distribution territory to include all or a portion"
revenue sharing payments financial
"required to reach total PermeaDerm revenue sharing payments of $1.0 million"
volume cap financial
"plus a 10% manufacturing fee, subject to a reasonable volume cap"
A volume cap is a limit set on the total amount of certain types of investments that can be made within a specific period. It helps control how much of these investments are available, much like a maximum number of tickets sold for an event. For investors, understanding volume caps is important because they influence how much opportunity there is to buy or sell certain assets, affecting market activity and investment strategies.

FAQ

What agreement did AVITA Medical (RCEL) modify with Stedical Scientific?
AVITA Medical and Stedical Scientific executed a Global Amendment to their existing distribution and manufacturing agreements for PermeaDerm, updating revenue-sharing terms, minimum payment requirements, and territorial rights, including potential expansion into the EU, UK, and Australia.

How does the PermeaDerm revenue share change for AVITA Medical (RCEL)?
AVITA’s share of PermeaDerm revenue increases to 67% for sheet products and 80% for glove products. These percentages are subject to additional revenue sharing if AVITA’s gross margins exceed 50% for sheets and 35% for gloves.

What minimum PermeaDerm payments must AVITA Medical (RCEL) achieve?
For 2026, AVITA must reach total PermeaDerm revenue sharing payments of $1.0 million, with 20% minimum annual growth in these payments each year through 2030. All prior minimum revenue sharing payment requirements are waived under the amendment.

What territorial rights does AVITA Medical (RCEL) gain under the Global Amendment?
In exchange for a $500,000 fee, AVITA receives a right of first offer and refusal to expand its exclusive PermeaDerm distribution territory to include all or part of the European Union, the United Kingdom, and/or Australia.

How will AVITA Medical (RCEL) price PermeaDerm sold to Stedical in and outside the U.S.?
For certain U.S. markets not served by AVITA, PermeaDerm will be sold to Stedical at a 10% premium to AVITA’s manufacturing costs. For ex-U.S. sales, primarily in Asia, AVITA will charge $200 per carton plus a 10% manufacturing fee, subject to a volume cap.

Can Stedical sell PermeaDerm independently of AVITA Medical (RCEL) in some markets?
Yes. Under the Global Amendment, Stedical may commercialize PermeaDerm in certain U.S. markets not currently served by AVITA. AVITA will supply PermeaDerm to Stedical under defined pricing terms for both U.S. and non-U.S. (primarily Asian) markets.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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0001762303false00017623032026-08-052026-08-05

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 05, 2026

 

 

AVITA Medical, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39059

85-1021707

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

28159 Avenue Stanford

Suite 220

 

Valencia, California

 

91355

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 661 367-9170

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

RCEL

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Item 1.01 Entry into a Material Definitive Agreement.

On August 5, 2026, the Company and Stedical Scientific, Inc. (“Stedical”) entered into a Global Amendment of their existing distribution agreement and manufacturing agreement (the “Global Amendment”). Under the terms of the Global Amendment, in exchange for a $500,000 fee the Company will hold the right of first offer and refusal to expand its exclusive distribution territory to include all or a portion of the European Union, the United Kingdom, and/or Australia. In addition, the Company’s share of revenue from PermeaDerm sales will increase to 67% for products sold in sheet form, subject to increased revenue sharing in the event the Company’s gross margin on those products exceeds 50%, and to 80% for products sold in glove form, subject to increased revenue sharing in the event the Company’s gross margin on those products exceeds 35%. For 2026, the Company is required to reach total PermeaDerm revenue sharing payments of $1.0 million, with 20% growth minimums each year through 2030. All previous minimum revenue sharing payment requirements under the Distribution Agreement were waived.

 

Also under the Global Amendment, Stedical may pursue the commercialization of PermeaDerm in certain U.S. markets not currently served by the Company. The Company will sell PermeaDerm for such sales to Stedical at a ten percent premium to the Company’s actual manufacturing costs. For PermeaDerm manufactured for Stedical to sell outside of the U.S., primarily in Asia, the Company will sell such PermeaDerm to Stedical at $200 per carton plus a 10% manufacturing fee, subject to a reasonable volume cap.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.

Description of Exhibit

10.1

Global Amendment to the Contract Manufacturing Agreement and Exclusive Distribution Agreement between the registrant and Stedical Scientific, Inc. *

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* Certain confidential portions of this exhibit have been omitted and redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K because the identified information is both not material and is the type that the registrant treats as private or confidential and/or would be competitively harmful if publicly disclosed.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

AVITA MEDICAL, INC.

 

 

 

 

Date:

August 11, 2026

By:

/s/ David O'Toole

 

 

 

Name: David O'Toole
Title: Chief Financial Officer

 

Source: View Original Filing on SEC EDGAR

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