What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2026-03-19 compared with 2025-03-20 · 356 added, 364 removed, 222 unchanged (76% of the section changed)

are a United States based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of

dermatological conditions with a focus on photodynamic therapy (“PDT”).

The Company’s primary licensed products,

which include Ameluz ® as well as the BF-RhodoLED ® and RhodoLED ® XL lamps (together, the

“RhodoLED ® Lamps”), are used for the treatment of actinic keratoses (“AKs”), which are

pre-cancerous skin lesions.

With our national commercial team, we generate revenue by selling our licensed products directly

to dermatology offices and groups.

We were formed in March 2015 as Biofrontera

Inc., a Delaware corporation, and a wholly owned subsidiary of Biofrontera AG, a stock corporation organized under the laws of

We consummated our initial public offering in November 2021.

Discovery was formed on February 9, 2022, as a German presence

that manages our clinical trial work and facilitates our relationship with the Ameluz Licensor.

We consider the Biofrontera

Group to be a related party.

The Biofrontera Group held more than 5% of the outstanding shares of our common stock until December

10, 2024, and we continue to rely on the Biofrontera Group as the sole supplier of Ameluz ® and the RhodoLED ® Lamps.

June 1, 2024, we assumed control of all clinical trials relating to Ameluz ® in the United States, allowing for more

effective cost management and direct oversight of trial efficiency.

We are a United States based biopharmaceutical company engaging in the development,

manufacturing, and commercialization of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic

therapy (“PDT”).

The Company’s products, which include Ameluz as well as the BF-RhodoLED and RhodoLED XL lamp series

(together, the “RhodoLED Lamps”), are used for the treatment of actinic keratosis (“AK”), a common skin condition

characterized by the growth of pre-cancerous lesions (or “AKs”).

With our national commercial team, we generate revenue by

selling our products directly to dermatology offices and groups.

were formed in 2015 as Biofrontera Inc., a Delaware corporation, and a wholly owned subsidiary of Biofrontera AG, a stock corporation

organized under the laws of Germany.

In 2021, we completed our initial public offering.

Effective June 1, 2024, we assumed control of

all clinical trials relating to Ameluz in the United States, allowing for more effective cost management and direct oversight of trial

efficiency through Discovery, our wholly owned subsidiary that was formed in Germany in 2022.

Our research and development (“R&D”) programs

are focused on label expansion for Ameluz ® as well as supporting PDT growth by improving the capabilities of

the RhodoLED ® Lamps to better fulfill the needs of dermatologists.

the third quarter of 2024, the Company reached the decision to divest its Xepi product line and the related intangible asset is

currently held for sale.

Xepi ® (ozenoxacin cream, 1%), is a topical non-fluorinated quinolone that

inhibits bacterial growth.

Currently, no antibiotic resistance against Xepi ® is known and it has been

specifically approved by the Federal Drug Administration (the “FDA”) for the treatment of impetigo, a common skin

infection, due to Staphylococcus aureus or Streptococcus pyogenes.

The Company did not have any sales of Xepi ® during

2024 and generated limited revenue during 2023 from sales of Xepi due to third-party manufacturing delays that have impacted our

commercialization of the product.

Ferrer is in the process of qualifying a new contract manufacturer.

If the new contract

manufacturer is qualified, we believe that it will be able to supply enough of the Xepi ® product line to meet

market demand for as long as we maintain it.

However, the Company is working with a potential purchaser and expects to complete a

sale of the asset within the next three to six months.

The related intangible asset is presented as held for sale under current

assets in the Consolidated Balance Sheets.

Assets Held for Sale , for additional information.

principal objective is to improve patient outcomes through adoption and use of our licensed products.

The key elements of our strategy

include the following:

our sales in the United States of Ameluz ® in combination with the RhodoLED ® Lamps for the treatment of

minimally to moderately thick AKs of the face and scalp and positioning Ameluz ® to be the standard of care in the

United States by leveraging new label indications and focusing on acquisition of new customers and growth of the therapy in our

current customer base;

the potential for future approvals and label extensions of our licensed portfolio products that are in the pipeline for the United States

market with respect to Ameluz and furthering the clinical development of

Ameluz ® after taking over responsibility for certain ongoing clinical trials since

June 1, 2024, pursuant to the Second A&R Ameluz LSA;

are focused on label expansion for Ameluz as well as supporting PDT growth by improving the capabilities of the RhodoLED Lamps to better

fulfill the needs of dermatologists.

On October 20, 2025, we entered into i) an Asset Purchase Agreement (the

“Transfer Agreement”) and ii) an Earnout Agreement (together with the Transfer Agreement, the “Agreements”), with

the Biofrontera Group, pursuant to which the Company acquired all rights in the United States to Ameluz and RhodoLED (the “Strategic

Transaction”).

Asset Acquisition and Note 16.

Related Party Transactions for additional information.

On November 6, 2025, the Company completed the sale of the intangible asset

relating to its Xepi product line, a long-lived asset previously classified as held for sale.

Assets Held for Sale ,

for additional information.

principal objective is to improve patient outcomes in the non-melanoma space through adoption and use of our products.

The key elements

of our strategy include the following:

expand our sales in the United States of Ameluz in combination with the

RhodoLED Lamps for the treatment of minimally to moderately thick AKs of the face and scalp and positioning Ameluz to be the standard

of care in the United States by leveraging new label indications and focusing on acquisition of new customers and growth of the therapy

in our current customer base;

leverage the potential for future approvals and label extensions of our

portfolio products that are in the pipeline for the United States market with respect to Ameluz and furthering the clinical development

of Ameluz after taking over responsibility for certain ongoing clinical trials since June 1, 2024;

strategically

manage our licensed portfolio, including opportunistically adding complementary products or services to our portfolio by acquiring

or licensing intellectual property to further leverage our commercial infrastructure and customer relationships.

executing these strategic objectives and continually evaluating our product portfolio with strategic options to improve our business, we will fuel growth, deepen our trusted relationships in the dermatology community, and

above all, help patients live healthier, more fulfilling lives.

As of December 31, 2024, the Company had 93 employees,

consisting of 92 full-time employees and one part-time employee.

Our commercial team covers the continental United States, and our headquarters

is in Woburn, MA.

Significant Customers

We have a wide and

diverse customer base with no single customer dominating our revenues.

At December 31, 2024, no customer represented more than 10% of

the net accounts receivable balance.

For the year ended December 31, 2024, no customer represented more than 10 %

of net revenues.

manage our portfolio, including opportunistically adding complementary products or services to our portfolio by acquiring or licensing

intellectual property to further leverage our commercial infrastructure and customer relationships.

executing these strategic objectives and continually evaluating our product portfolio with strategic options to improve our business,

we will fuel growth, deepen our trusted relationships in the dermatology community, and above all, help patients live healthier, more

fulfilling lives.

of December 31, 2025, the Company had a total of 92 employees comprised of 75 employees (72 full-time and three part-time) in

the United Sates and 19 employees located in Germany (12 full-time and seven part-time).

have a wide and diverse customer base with no single customer dominating our revenues.

At December 31, 2025, no customer represented

more than 10% of the net accounts receivable balance.

For the year ended December 31, 2025, no customer represented more than 10% of

net revenues.

However, many of our existing and potential customers for our products have combined or could choose to combine in the

near future to form GPOs in an effort to lower costs.

See GPO Risk Factor in Item 1A.

Risk Factors- Risks Related to Our Business

and RhodoLED Lamps

principal licensed product is Ameluz ® , which is a prescription drug approved for use in combination with the RhodoLED ®

Lamps, for PDT (when used together, “Ameluz ® PDT”).

In the United States, the PDT treatment is

used for the lesion-directed and field-directed treatment of actinic keratosis (“AK”) of mild-to-moderate severity on the

face and scalp.

AKs are premalignant lesions of the skin that can potentially develop into skin cancer (squamous cell carcinoma) if left

1 International treatment guidelines list PDT as the “gold standard” for treating AK, especially multiple

AKs and the surrounding photodamaged skin.

2 We are currently selling Ameluz ® for this indication in the United States

under an exclusive license and supply agreement between Biofrontera Inc.

and the Ameluz Licensor, (the “Second A&R Ameluz LSA”).

principal product is Ameluz, which is a prescription drug approved for use in combination with the RhodoLED Lamps, for PDT (when used

together, “Ameluz PDT”).

In the United States, the PDT treatment is used for the lesion-directed and field-directed treatment

of AK of mild-to-moderate severity on the face and scalp.

AKs are premalignant lesions of the skin that can potentially

develop into skin cancer (squamous cell carcinoma) if left untreated.

1 International treatment guidelines list PDT as the

“gold standard” for treating AK, especially multiple AKs and the surrounding photodamaged skin.

the number one indication at a dermatologist visit for those 40 and older, are superficial potentially pre-cancerous skin lesions caused

7 unchanged sentences

first step is the application of a drug known as a “photosensitizer,” or a pre-cursor of this type of drug, which tends

to accumulate in cancerous cells;

second step is activation of the photosensitizer by controlled exposure to a selective light source in the presence of oxygen.

to accumulate in fast growing cells at a faster rate compared to healthy cells;

second step is activation of the photosensitizer by controlled exposure to a selective light source in the presence of oxygen to

selectively destroy the fast growing cells.

this process, energy from the light activates the photosensitizer.

In PDT, the activated photosensitizer transfers energy to oxygen molecules

found in cells, converting the oxygen into a highly reactive oxygen species (“ROS”), which destroys or alters the sensitized

PDT can be a highly selective treatment that targets specific cells while minimizing damage to normal surrounding tissues.

also can allow for multiple courses of therapy.

Hence the mode of action of PDT requires destruction of the altered cells, and temporary

local skin reactions and inflammation of the treated area might be expected.

The Ameluz ® PDT therapy is highly effective

with patients - efficacy is up to 91% clearance after one or two treatments 3 with limited or no scarring.

The therapy also

may provide protection from potentially fatal progress of mild AKs.

found in cells, converting the oxygen into a highly reactive oxygen species, which destroys or alters the sensitized cells.

a highly selective treatment that targets specific cells while minimizing damage to normal surrounding tissues.

It also can allow for

multiple courses of therapy.

Hence the mode of action of PDT requires destruction of the altered cells, and temporary local skin reactions

and inflammation of the treated area might be expected.

The Ameluz PDT therapy is highly effective with patients - efficacy

is up to 91% clearance after one or two treatments 3 with limited or no scarring.

The therapy also may provide protection from

potentially fatal progress of mild AKs.

and competitive landscape

1 unchanged sentence

it affects more than 58 million Americans.

5 Cryotherapy is

the traditional and most common form of treatment but may not be as effective and may leave scarring;

cryotherapy is estimated to be

approximately 86% of the market.

Topicals, medications which patients apply to the lesion multiple times per day for up to several weeks,

constitute approximately 12% of the market.

5 Cryotherapy is the traditional and most

common form of treatment but may not be as effective and may leave scarring;

cryotherapy is estimated to be approximately 86% of the

Topicals, medications which patients apply to the lesion multiple times per day for up to several weeks, constitute approximately

12% of the market.

PDT is approximately 2% of the market.

The total market size is estimated to be roughly $4

billion for the three therapy types.

The total market size is estimated to be roughly $4 billion for the three therapy

Our primary competitor in the PDT space is Levulan ® and the associated light, Blu-U ® .

goal is to continue expansion in the current PDT market and focus on converting cryotherapy treatments of more than 14 lesions to

Ameluz ® PDT as the switch or even combination of cryotherapy and PDT could be more effective and lead to better

patient outcomes.

Ameluz PDT as the switch or even combination of cryotherapy and PDT could be more effective and lead to better patient outcomes.

This targeted market is about 11% or $500 million of the total AK market.

6 Ameluz ® PDT

is competitive in the market.

We are leveraging medical affairs, advisory boards, reimbursement resources, and key opinion leaders

in order to educate the market on the use and benefits of Ameluz ® PDT.

6 Ameluz PDT is competitive in the market.

are leveraging medical affairs, leading educational, CME- and non-CME programs, participating in thought leader advisory boards and

focus groups, and offering reimbursement resources in order to educate the market on the use and benefits of Ameluz PDT.

Fuchs, A., & Marmur, E.

14 unchanged sentences

marketing and distribution

are currently selling our licensed products in the United States through the use of our own commercial organization.

have a single sales force who markets all our licensed products across the dermatology space.

We launched the commercialization of Ameluz ®

in combination with the RhodoLED ® lamp for the treatment of actinic keratosis in the United States in October 2016.

are currently selling our products in the United States through the use of our own commercial organization.

We have a single sales

force who markets all our products across the dermatology space.

We launched the commercialization of Ameluz in combination with the

RhodoLED lamp for the treatment of AK in the United States in October 2016.

Ameluz PDT is an in-office procedure.

Ameluz ® is distributed as a “buy-and-bill” drug that

is purchased by the dermatologist, rather than distribution through pharmacies.

Our customers will purchase our device and Ameluz ®

which will be held in inventory.

When a dermatologist uses our product in a treatment, a payor will be billed, and the provider

will be paid for both the product and light treatment.

There are well established PDT CPT Codes.

Ameluz ® PDT is covered

by code number 96574 which has an average reimbursement of $262.68 per light treatment and has to be performed by a qualified healthcare

professional.

Public information regarding CPT reimbursement is available at https://www.cms.gov/medicare/physician-fee-schedule/search?Y=0&T=4&HT=0&CT=3&H1=96574&M=5.

are a sales organization with a focus on commercializing our portfolio of licensed products that are already FDA-approved.

Second A&R Ameluz LSA, we hold the exclusive license to sell Ameluz ® and the RhodoLED ® Lamps in the

United States for all indications currently approved by the FDA as well as all future FDA-approved indications identified under the Second

A&R Ameluz LSA.

June 1, 2024, in accordance with the Second A&R Ameluz LSA, the Company assumed control of all clinical trials relating to

Ameluz ® in the US, allowing for more effective cost management and direct oversight of trial efficiency.

to R&D spending will be partially offset by the reduced price we pay per unit for Ameluz ® , based on certain

percentages of the anticipated net selling price, (the “Transfer Price”) that covers the cost of goods, royalties on

sales, and services including all regulatory efforts, agency fees, pharmacovigilance, and patent administration.

This will allow the

Company to finance such R&D activities and continue our commercial growth trajectory.

Our R&D programs are

focused on label expansion for Ameluz ® as well as supporting PDT growth by improving the capabilities of our

RhodoLED ® Lamps to better fulfill the needs of dermatologists.

distributed as a “buy-and-bill” drug that is purchased by the dermatologist, rather than distribution through

Our customers will purchase our device and Ameluz which will be held in inventory.

When a dermatologist uses our product

in a treatment, a payor will be billed, and the provider will be paid for both the product and light treatment.

There are three well

established PDT Current Procedural Terminology (“CPT”) Codes related to Ameluz PDT treatments:

1) code number 96567,

which has an average reimbursement of $129.26 per light treatment, 2) code number 96573, which has an average reimbursement of

$217.44 per light treatment performed by qualified health care professional, or 3) code number 96574 which has an average

reimbursement of $266.87 per debridement of a hyperkeratotic AK lesion followed by a light treatment performed by a

qualified health care professional.

June 1, 2024, the Company assumed control of all clinical trials relating to Ameluz in the US, allowing for more effective cost management

and direct oversight of trial efficiency.

Our R&D programs are focused on label expansion for Ameluz as well as supporting PDT growth

by improving the capabilities of our RhodoLED Lamps to better fulfill the needs of dermatologists.

October 20, 2025, we acquired all rights in the United States to Ameluz and the RhodoLED Lamps for all indications currently

approved by the Food and Drug Administration (the “FDA”) as well as all future FDA-approved indications.

summary of our clinical trials is below:

basal cell carcinoma

Last-patient-out

for 1 year follow up completed in December 2024;

Clinical Study Report (“CSR”) expected Q2 – 2025.

to FDA in Q4 2025.

to severe acne

Last-patient-out

of treatment phase expected Q3 2025.

CSR for treatment expected in Q2 2026.

of treatment phase in Q3 2025.

Phase 2 data obtained in Q1 2026.

Clinical Study Report (“CSR”) for treatment phase

expected Q3 2026.

& extremities applying 1-3 tubes of Ameluz .

last patient-in was March 2025.

Last-patient-out of treatment phase expected Q3-2025.

CSR expected in Q2-2026.

daylight and conventional PDT, plan to start enrollment in 2026

cell carcinoma in situ

to start enrollment in 2026

new, larger RhodoLED ® XL was approved by the FDA in 2021 for use in combination with Ameluz ® for the treatment

of mild and moderate actinic keratoses on the face and scalp, which corresponds to the current approval of Ameluz ® .

launched the RhodoLED ® XL in June 2024.

The new PDT-lamp enables the illumination of larger areas, thus allowing the simultaneous

treatment of several actinic keratoses distant from each other.

The smaller BF-RhodoLED ® model will continue to be offered

in the United States market.

October 2024, the FDA approved the Company’s Supplemental New Drug Application to increase the maximally approved dosage of Ameluz ® from

one to three tubes per treatment.

Last-patient-out of treatment phase in Q3 2025.

CSR for treatment phase

expected Q2 2026.

filing for sNDA is expected for Q3 2026 for field treatment of AKs on extremities and neck and

Trunk & extremities pharmacokinetics study applying 3 tubes of Ameluz.

Last-patient-out in Q4 2025.

CSR expected Q2 2026.

filing expected together with trunk and extremities phase 3 study in Q3 2026.

AK Pain Reduction;

Plan to start enrollment in 2027

The new, larger RhodoLED XL was approved by the FDA in 2021 for use in combination

with Ameluz for the treatment of mild and moderate AKs on the face and scalp, which corresponds to the current approval of Ameluz and

was launched in June 2024.

The RhodoLED XL enables the illumination of larger areas, thus allowing the simultaneous treatment of several

AKs distant from each other.

The smaller BF-RhodoLED model will continue to be offered in the United States market.

October 2024, the FDA approved the Company’s Supplemental New Drug Application to increase the maximally approved dosage of Ameluz

from one to three tubes per treatment.

This approval allows healthcare professionals greater flexibility in addressing larger or multiple

1 unchanged sentence

and their patients.

In combination with the RhodoLED ® XL Lamp, providers can now treat a patient’s face more

Additionally, the change to the label and the RhodoLED ® XL are both foundational to support trunk and

extremities which we expect to add to the label in the next couple of years.

In combination with the RhodoLED XL Lamp, providers can now treat a patient’s face more efficiently.

Additionally,

the change to the label and the RhodoLED XL are both foundational to support trunk and extremities which we expect to add to the label

Regulatory submission for the trunk and extremities label change is planned for the second quarter of 2026.

in October 2024, the Company received results in its Phase III trial evaluating Ameluz PDT as a treatment for superficial basal cell

3 unchanged sentences

According to the phase

III ALA-BCC-CT013 study, Ameluz®-PDT achieved 65.5% success, compared to 4.8% success achieved with placebo-PDT.

histological clearance was seen in 75.9% of these lesions in the Ameluz® arm, compared to 19.0% with placebo.

Complete clinical

clearance was achieved in 83.4% of patients treated with Ameluz® compared to 21.4% with placebo.

Additionally,

our licensor has been granted a patent for a pain-reduced PDT procedure that combines daylight and conventional PDT and, if the respective

Phase III trial leads to inclusion of the procedure into the Ameluz ® label, may provide further patent protection beyond

Furthermore, in 2023, the FDA approved a new formulation of Ameluz ® that lacks propylene glycol and reduces the

accumulation of certain contaminants over time.

The new formulation was implemented in all US productions of Ameluz ® starting

A corresponding patent application has been filed with the United States Patent and Trademark Office, or USPTO, which, if granted, will

extend protection of Ameluz ® to 2043.

source for the Ameluz ® and the RhodoLED ® Lamps is our Licensor, Biofrontera Pharma, who is considered

the responsible manufacturer for Ameluz ® by the FDA.

Biofrontera Pharma currently manufactures through a single unaffiliated

contract manufacturer in Switzerland, Glaropharm AG, and is in the process of qualifying a second unaffiliated contract manufacturer

located in Germany, Pharbil Waltrop GmbH, to ensure stability of the supply chain.

Our Licensor is responsible for all raw materials,

product, and shipment of products to our third-party logistics partner (“3PL”), Cardinal Health for warehousing and distribution.

We centralize our customer sales support and back-office functions through our headquarters in Woburn, Massachusetts.

do not own any material patents or trademarks.

We license the rights and trademarks related to the products we sell.

and the RhodoLED ® Lamps are approved by the FDA as a combination product, such that the label requires the use of

both products together.

The Licensor has patent protection on its nanoemulsion technology in the United States until 2028 and three new

patent family applications on the RhodoLED ® Lamps and general PDT illumination procedures, two of which are already granted,

and one is listed in the Orange Book, that could jointly extend protection until 2040.

Additionally, a new patent regarding an Ameluz

formulation without propylene glycol filed at USPTO in 2024, if granted, extends protection to 2043.

Partners and Agreements

and RhodoLED ® Lamps License Service Agreement

February 19, 2024, the Company entered into the Second A&R Ameluz

LSA with the Ameluz Licensor, effective February 13, 2024.

The Second A&R Ameluz LSA amended and restated the

Ameluz License and Supply Agreement, originally dated as of October 1, 2016, which was subsequently amended on July 1, 2019, June 16,

2021, October 8, 2021, December 5, 2023, and January 26, 2024.

Under the terms of

the Second A&R Ameluz LSA, we have an exclusive, non-transferable license from the Ameluz Licensor technology to use, import, export,

distribute, market, offer for sale and sell Ameluz ® and the RhodoLED ® Lamps for its approved indications

within the United States and certain of its territories.

The Second A&R Ameluz LSA will remain in effect for 15 years from its effective

date and automatically renew for a period of five years, in perpetuity as long as certain minimum revenues are achieved.

Commitments and Contingencies.

other things, the Second A&R Ameluz LSA reduced the Transfer Price of Ameluz ® from 50% to 25% for all purchases

in 2024 and 2025.

Starting on January 1, 2026, until 2032 there will be stepwise increases in the Transfer Price from 25% to 35% for

sales related to actinic keratosis and, if approved by the FDA, basal cell carcinoma and squamous cell carcinoma indications.

Transfer Price for sales related to acne, another indication currently in development, will remain at 25% indefinitely.

Price covers the cost of goods, royalties on sales, and services including all regulatory efforts, agency fees, pharmacovigilance,

and patent administration.

Effective June 1, 2024, the Company assumed control of all clinical trials with Ameluz ®

in the US, allowing for more effective cost management and direct oversight of trial efficiency.

The reduced Transfer Price in the Second

A&R Ameluz LSA will allow the Company to finance such R&D activities and continue our commercial growth trajectory.

The Ameluz Licensor sell us the RhodoLED ® Lamps at cost plus a low double digit handling fee.

There are no milestones or royalty obligations associated with this agreement.

Any changes to the pricing of supply of Ameluz ®

or RhodoLED ® Lamps would require agreement by both contract parties.

Ameluz Licensor is responsible for obtaining and maintaining the rights to all FDA approvals (and any required maintenance thereafter)

needed for the Ameluz Licensor to manufacture Ameluz ® and/or the RhodoLED ® Lamps and/or for Biofrontera

to sell Ameluz ® and/or the RhodoLED ® Lamps in the United States.

Likewise, the Ameluz Licensor is

responsible to maintain a pharmacovigilance database and to respond appropriately to all relevant queries of any regulatory authority

pertaining to pharmacovigilance Biofrontera is required to provide reasonable support relating to any regulatory issues relating to pharmacovigilance

and/or product recalls.

Biofrontera is responsible for obtaining all state licenses or any other similar approvals required to market Ameluz ® and/or

the RhodoLED ® Lamps in the United States.

Biofrontera must also carry out all mandatory reporting responsibilities under

federal and state law with respect to compliance with the Prescription Drug Marketing Act, the Sunshine Act, or any other similar laws

and regulations.

Biofrontera is also responsible for all activities related to reimbursement and pricing of the products within the United

Biofrontera is required to use commercially reasonable efforts and resources to exploit the license and market Ameluz ®

and the RhodoLED ® Lamps in the United States.

product or lamps are not delivered in conformance with certain specifications of this Agreement and the Quality Agreement dated

November 1, 2016, between the Company and Biofrontera Pharma, and the Ameluz Licensor does not remedy its failure, then we

will have the right to organize manufacturing on our own, and step into contracts with the Ameluz Licensor’s manufacturers,

such that we will replace the Ameluz Licensor as a party to these contracts.

If we pursue this option, Ameluz Licensor must use its

best efforts to assist with the transferring of these manufacturing contracts without delay and at its own cost.

No Transfer Price

will be paid to the Ameluz Licensor thereafter for products or lamps that are manufactured by third parties.

III ALA-BCC-CT013 study, Ameluz-PDT achieved 65.5% success in the composite endpoint, compared to 4.8% success achieved with

Complete histological clearance was seen in 75.9% of these lesions in the Ameluz arm, compared to 19.0% with placebo.

Complete clinical clearance was achieved in 83.4% of patients treated with Ameluz compared to 21.4% with placebo.

In November 2025 a

Supplemental New Drug Application was submitted to the FDA, applying for the approval of the treatment of sBCC by PDT with Ameluz

and the BF-RhodoLED or the RhodoLED XL lamp .

accepted the filing and set a Prescription Drug User Fee Act date of September 28, 2026.

F urthermore, the FDA approved a new

formulation of Ameluz that lacks propylene glycol and reduces the accumulation of certain contaminants over time.

A corresponding patent

application was granted by the United States Patent and Trademark Office, (the “USPTO”), extending protection of Ameluz to

The new formulation has been implemented in all US productions of Ameluz since 2024 .

Traditional PDT treatments using a lamp are usually performed more frequently

during the winter.

As such, our revenue is subject to some seasonality and has historically been higher during the first and fourth quarters

of the year than during the second and third quarters.

Suppliers & Manufacturers

Historically, we have relied on Biofrontera

Pharma (the “Former Ameluz Licensor”) as the principal supplier and manufacturer of

our products.

However, in conjunction with a Strategic Transaction, the Company assumed full control of the Ameluz New Drug Application and Investigational New Drug, enabling the Company to take full

responsibility for all aspects of manufacturing Ameluz and the RhodoLED Lamps in the U.S.

Pursuant to the Strategic Transaction, we will

temporarily continue to rely on the Former Ameluz Licensor for the manufacturing of Ameluz until we secure all necessary licenses

and implement all necessary contracts to fully assume these responsibilities.

In preparation of the same, we have entered into an

agreement for the primary procurement of our active pharmaceutical ingredient (“API”) with Midas Pharma GmbH, located in

We have also identified a secondary source of API and anticipate entering into a similar agreement with this supplier.

Production of Ameluz is carried out by a

contract manufacturer, Glaropharm AG in Switzerland, as well as a second contract manufacturer located in Germany, Pharbil Waltrop

GmbH, who has recently been qualified for manufacturing of Ameluz to ensure stability of the supply chain and help manage possible

tariff impacts.

Production of the RhodoLED Lamps is currently carried out by the Former Ameluz Licensor in Leverkusen, Germany, which

responsibility will be transferred to Discovery pursuant to the Strategic Transaction.

See Part 1, Item 7, “Overview and

Recent Developments” for more information concerning the Strategic Transaction.

We centralize our customer sales support and back-office

functions through our headquarters in Woburn, Massachusetts.

rely on a combination of patents, trademarks, copyrights, trade secrets and other proprietary know-how and regulatory exclusivities,

as well as contractual protections, to establish and protect our intellectual property rights.

We consider the overall protection of

our intellectual property rights to be of material value and act to protect these rights from infringement.

have patent protection related to our innovative technologies and developments in connection with our nanoemulsion technology, the RhodoLED

Lamps and general PDT illumination procedures.

patents awarded by the USPTO to the Company that are material to an understanding of the Company

are listed in the table below :

Date/ Filing Date

for photodynamic therapy

device for photodynamic therapy, method for treating a skin disease and method for operating

an illumination

Panel for a photodynamic therapy lamp

Therapy Lamp Head

formulation with improved stability and cell penetration

without propylene glycol

therapy comprising two light exposures at different wavelengths

pending filed by the Company that are material to an understanding of the Company are as follows:

Application Serial No.

Issue Date/ Filing Date

for photodynamic therapy

device for photodynamic therapy, method for treating a skin disease and method for operating

an illumination

device for photodynamic therapy, method for treating a skin disease and method for operating

an illumination

device for photodynamic therapy, method for treating a skin disease and method for operating

an illumination

Panel for a photodynamic therapy lamp

Therapy Lamp Head

without propylene glycol

therapy comprising two light exposures at different wavelengths

Commercial Partners and Agreements

Ameluz and RhodoLED Lamps License

Service Agreement

On February 19, 2024, the Company

entered into the Second Amended and Restated License and Supply Agreement (the “Second A&R Ameluz LSA”) with the Former Ameluz Licensor, effective February 13, 2024.

Among other things, the Second A&R Ameluz LSA established the “Transfer Price”

of Ameluz at 25% for all purchases in 2024 and 2025.

The Transfer Price covered the cost of goods, royalties on sales, and services

including all regulatory efforts, agency fees, pharmacovigilance, and patent administration.

Under the Second A&R Ameluz LSA, the

Former Ameluz Licensor was responsible for obtaining and maintaining the rights to all FDA approvals (and any required maintenance

thereafter) needed for the Former Ameluz Licensor to manufacture Ameluz and/or the RhodoLED Lamps and/or for Biofrontera to

sell Ameluz and/or the RhodoLED Lamps in the United States.

Likewise, the Former Ameluz Licensor was responsible to

maintain a pharmacovigilance database and to respond appropriately to all relevant queries of any regulatory authority pertaining to

pharmacovigilance.

Biofrontera was required to provide reasonable support relating to any regulatory issues relating to

pharmacovigilance and/or product recalls, obtaining all state licenses or any other similar approvals required to market

Ameluz and/or the RhodoLED Lamps in the United States, and carrying out all mandatory reporting responsibilities

under federal and state law with respect to compliance with the Prescription Drug Marketing Act, the Sunshine Act, or any other

similar laws and regulations.

The Second A&R Ameluz LSA was terminated in connection with the Strategic Transaction.

Item 7, “Overview and Recent Developments” for more information concerning the Strategic Transaction.

and Industry Regulation

11 unchanged sentences

require significant technical expertise and capital investment to ensure compliance.

Cost containment efforts by governmental authorities and health care reform

continue to exert pressure on product pricing and market access.

Pricing pressure continues to be influenced by the power exerted through

entities negotiating on behalf of federal health care programs such as Medicare and Medicaid, as well as managed care programs, and commercial

insurance plans.

We are also seeing government-mandated pricing restrictions aimed at reducing prices and promoting generic drugs adding

increased competition and pricing pressure in the market.

Congress continues to consider and discuss legislation aimed at reducing

health care costs, including lowering the price of drugs and biologics.

containment efforts by governmental authorities and health care reform continue to exert pressure on product pricing and market access.

Pricing pressure continues to be influenced by the power exerted through entities negotiating on behalf of federal health care programs

such as Medicare and Medicaid, as well as managed care programs, and commercial insurance plans.

We are also seeing government-mandated

pricing restrictions aimed at reducing prices and promoting generic drugs adding increased competition and pricing pressure in the market.

Congress continues to consider and discuss legislation aimed at reducing health care costs, including lowering the price of

drugs and biologics.

States Drug Development and Review

2 unchanged sentences

United States system of new drug and biologics approval is a rigorous process.

The following general comments about the drug approval process

are relevant to the development activities related to our products.

The following general comments about the drug approval

process are relevant to the development activities related to our products.

Investigational

8 unchanged sentences

2 Clinical Trials:

In Phase 2 clinical trials, controlled studies of human patients with the targeted disease/condition are conducted to assess

the drug’s effectiveness.

These studies are designed primarily to determine the appropriate dose levels, dose schedules and route(s)

of administration, and to evaluate the effectiveness of the drug or biologic on humans, as well as to determine if there are any side

effects on humans to expand the safety profile following Phase 1.

These clinical trials, and Phase 3 trials discussed below, are designed

to evaluate the product’s overall benefit-risk profile, and to provide information for physician labeling.

In Phase 2 clinical trials, controlled studies of human patients with the targeted disease/condition are conducted

to assess the drug’s effectiveness.

These studies are designed primarily to determine the appropriate dose levels, dose schedules

and route(s) of administration, and to evaluate the effectiveness of the drug or biologic on humans, as well as to determine if there

are any side effects on humans to expand the safety profile following Phase 1.

These clinical trials, and Phase 3 trials discussed below,

are designed to evaluate the product’s overall benefit-risk profile, and to provide information for physician labeling.

3 Clinical Trials:

This Phase usually involves a larger number of patients with the targeted disease/condition.

Investigators (typically physicians)

monitor the patients to determine the drug candidate’s efficacy and to observe and report any adverse reactions that may result

from long-term use of the drug on a large, more widespread, patient population.

Investigators (typically

physicians) monitor the patients to determine the drug candidate’s efficacy and to observe and report any adverse reactions that

may result from long-term use of the drug on a large, more widespread, patient population.

the Phase 3 clinical trials, typically the drug candidate is compared to either a placebo or a standard treatment for the target disease.

or Biologics License Application (“BLA”):

After completion of all three clinical trial Phases, if the data indicates that

the drug is safe and effective, an NDA or BLA is filed with the FDA requesting FDA approval to market the new drug as a treatment for

the target disease.

Drug Application (“NDA”) or Biologics License Application (“BLA”):

After completion of all three clinical trial

Phases, if the data indicates that the drug is safe and effective, an NDA or BLA is filed with the FDA requesting FDA approval to market

the new drug as a treatment for the target disease.

Evaluation and Mitigation Strategy Authority under the Food and Drug Administration Amendments Act (“FDAAA”):

16 unchanged sentences

systems data.

trials may experience delays or fail to demonstrate the safety and efficacy, which could prevent or significantly delay obtaining regulatory

trials may experience delays or fail to demonstrate safety and efficacy, which could prevent or significantly delay obtaining regulatory

trials require the investment of substantial financial and personnel resources.

The commencement and completion of clinical trials

may be delayed by various factors, including, without limitations, scheduling conflicts with participating clinicians and clinical

institutions, difficulties in identifying and enrolling patients who meet trial eligibility criteria, failure of patients to

complete the clinical trial, delays in accumulating the required number of clinical events for data analysis, delay or failure to

obtain the required approval to conduct a clinical trial at a prospective site, and shortages of available drug supply and clinicians.

the outcome of a clinical trial is often uncertain.

There may be numerous unforeseen events during, or as a result of, the clinical

trial process that could delay or prevent regulatory approval.

In addition, the results of early-stage clinical trials do not

necessarily predict the results of later-stage clinical trials.

Later-stage clinical trials may fail to demonstrate that a drug

product is safe and effective despite having progressed through initial clinical testing.

Clinical trial data results are

susceptible to varying interpretations, and such data may not be sufficient to support approval by the FDA.

The ability to commence

and complete clinical trials may be delayed by many factors that are beyond our control, including:

The commencement and completion of clinical trials may

be delayed by various factors, including, without limitations, scheduling conflicts with participating clinicians and clinical institutions,

difficulties in identifying and enrolling patients who meet trial eligibility criteria, failure of patients to complete the clinical

trial, delays in accumulating the required number of clinical events for data analysis, delay or failure to obtain the required approval

to conduct a clinical trial at a prospective site, and shortages of available drug supply and clinicians.

Moreover, the outcome of a

clinical trial is often uncertain.

There may be numerous unforeseen events during, or as a result of, the clinical trial process that

could delay or prevent regulatory approval.

In addition, the results of early-stage clinical trials do not necessarily predict the results

of later-stage clinical trials.

Later-stage clinical trials may fail to demonstrate that a drug product is safe and effective despite

having progressed through initial clinical testing.

Clinical trial data results are susceptible to varying interpretations, and such

data may not be sufficient to support approval by the FDA.

The ability to commence and complete clinical trials may be delayed by many

factors that are beyond our control, including:

obtaining regulatory approval to commence a trial;

20 unchanged sentences

drugs once they are approved.

of our licensed drug products that require FDA approvals are subject to continuing regulation by the FDA, including, among other things,

record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information,

product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among other

requirements, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in patient populations that are

not described in the drug’s approved labeling (known as “off-label use”), limitations on industry sponsored scientific

and educational activities, and requirements for promotional activities involving the internet.

Under the Second A&R Ameluz LSA,

these requirements are handled by both us and our Licensor.

Although physicians may prescribe legally available drugs for off-label uses,

manufacturers may not market or promote such off-label uses.

Any of our drug products that require FDA approvals are subject to continuing regulation by the FDA, including,

among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety

and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements,

which include, among other requirements, standards for direct-to-consumer advertising, restrictions on promoting drugs for uses or in

patient populations that are not described in the drug’s approved labeling (known as “off-label use”), limitations on

industry sponsored scientific and educational activities, and requirements for promotional activities involving the internet.

1, 2025, under the Second A&R Ameluz LSA, these requirements were handled by both us and our licensor.

See Part 1, Item 7, “Overview

and Recent Developments” for more information concerning the Second A&R Ameluz LSA.

Although physicians may prescribe legally

available drugs for off-label uses, manufacturers may not market or promote such off-label uses.

addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval.

We are relying exclusively on our licensors’ or their manufacturing partner’s facilities for the production of clinical and

commercial quantities of our products in accordance with Current Good Manufacturing Practices (“cGMP”) regulations.

regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of records and

documentation and the obligation to investigate and correct any deviations from cGMP.

Drug manufacturers and other entities involved

in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies

and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.

manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.

Discovery of problems with a product after approval may result in restrictions on a product manufacturer or holder of an approved NDA,

including, among other things, recall or withdrawal of the product from the market.

In addition, changes to the manufacturing process

are strictly regulated, and depending on the significance of the change, may require prior FDA approval before being implemented and

development of and submission of data to support the change.

Other types of changes to the approved product, such as adding new indications

and additional labeling claims, are also subject to further FDA review and approval, as well as, possibly, the development and submission

of data to support the change.

We rely, in part, on our manufacturing partner’s facilities for the production of clinical and commercial quantities of our products

in accordance with Current Good Manufacturing Practices (“cGMP”) regulations.

cGMP regulations require

among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the

obligation to investigate and correct any deviations from cGMP.

Drug manufacturers and other entities involved in the manufacture and

distribution of approved drugs are required to register their establishments with the FDA and certain state agencies and are subject

to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.

Accordingly, manufacturers

must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.

problems with a product after approval may result in restrictions on a product manufacturer or holder of an approved NDA, including,

among other things, recall or withdrawal of the product from the market.

In addition, changes to the manufacturing process are strictly

regulated, and depending on the significance of the change, may require prior FDA approval before being implemented and the development

and submission of data to support the change.

Other types of changes to the approved product, such as adding new indications and additional

labeling claims, are also subject to further FDA review and approval, as well as, possibly, the development and submission of data to

support the change.

FDA also may require post-approval, sometimes referred to as Phase 4, trials and surveillance to monitor the effects of an approved product

or place conditions on an approval that could restrict the distribution or use of the product.

Discovery of previously unknown problems

Detection of previously unknown problems

with a product or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity,

10 unchanged sentences

include, but are not limited to:

establishment registration and device listings with the FDA;

System Regulation, or QSR, which requires manufacturers, including third party manufacturers and certain other parties, to follow

stringent design, testing, process control, documentation, corrective action/preventive action, complaint handling and other quality

assurance procedures, as applicable;

and maintaining registration and device listings with the FDA;

System Regulation (“QSR”) which requires manufacturers, including third party manufacturers and certain other parties,

to follow stringent design, testing, process control, documentation, corrective action/preventive action, complaint handling and

other quality assurance procedures, as applicable;

statutes and regulations, which prohibit the promotion of products for uncleared or unapproved, or off-label uses and impose other

26 unchanged sentences

expenditures to address or defend such actions.

Licensors are subject to announced and unannounced device inspections by FDA and other regulatory agencies overseeing the implementation

and adherence of applicable local, state and federal statutes and regulations.

Safe Medical Devices Act

The Safe Medical Devices Act of 1990, as amended (“SMDA”),

amended the Federal Food, Drug, and Cosmetic Act to require medical device manufacturers and user facilities such as hospitals and ambulatory

surgical centers to report any adverse events associated with a medical device to the FDA.

It provides that FDA with two additional post-market

activities including monitoring of products after market clearance and device tracking for maintaining traceability of certain devices

to the user level.

The SMDA makes it mandatory for facilities, manufacturers, and importers to submit medical device reporting forms to

the FDA after becoming aware of a serious event associated with a device.

Manufacturers are required to submit baseline reports and reports

of deaths, serious injuries, and malfunctions associated with the device to the FDA.

are subject to announced and unannounced device inspections by FDA and other regulatory agencies overseeing the implementation and adherence

of applicable local, state and federal statutes and regulations.

Medical Devices Act

Safe Medical Devices Act of 1990, as amended (“SMDA”), amended the Federal Food, Drug, and Cosmetic Act to require medical

device manufacturers and user facilities such as hospitals and ambulatory surgical centers to report any adverse events associated with

a medical device to the FDA.

It also imposes two additional post-market requirements on manufacturers, including monitoring

of products after market clearance and device tracking for maintaining traceability of certain devices to the user level.

The SMDA makes

it mandatory for facilities, manufacturers, and importers to submit medical device reporting forms to the FDA after becoming aware of

a serious event associated with a device.

Manufacturers are required to submit baseline reports and reports of deaths, serious injuries,

and malfunctions associated with the device to the FDA.

and Abuse Laws

are subject to healthcare anti-fraud and abuse regulations that are enforced by the United States federal government and the states in which we

conduct our business.

are subject to healthcare anti-fraud and abuse regulations that are enforced by the United States federal government and the states in

which we conduct our business.

The laws that may affect our ability to operate include, without limitation:

35 unchanged sentences

under one or more of such laws.

false claims and false statement laws, including the federal civil False Claims Act, prohibits, among other things, any person or

entity from knowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare

and Medicaid, claims for items or services, including drugs, that are false or fraudulent or not provided as claimed.

be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for

example, providing inaccurate billing or coding information to customers, promoting a product off-label, or for providing medically

unnecessary services or items.

In addition, activities relating to the sale and marketing of products are subject to scrutiny under

Penalties for the federal civil False Claims Act violations may include up to three times the actual damages sustained by

the government, (commonly referred to as treble damages), plus mandatory civil penalties for each separate false claim, the

potential for exclusion from participation in federal health care programs, and, although the federal civil False Claims Act is a

civil statute, False Claims Act violations may also implicate various federal criminal statutes.

Physician Payments Sunshine Act

The Physician Payments Sunshine Act is a national disclosure program created

by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 that aims to

increase transparency in payments from medical device manufacturers and pharmaceutical companies to physicians and teaching hospitals.

In 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act expanded these

covered recipients to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists,

anesthesiologist assistants and certified nurse midwives.

Common payments in the industry to physicians and other “covered recipients”

can include consulting fees, honoraria, fees for training and education, research fees, gifts, vacations, food and beverage, travel and

lodging, charitable contributions, grants, ownership and investment interests, royalty or license fees, and compensation for serving as

faculty or a speaker.

Inflation Reduction Act (“IRA”)

The IRA, passed by Congress in 2022, makes significant

changes to how drugs are covered and paid for under the Medicare Program.

Creates financial penalties for drugs whose prices rise faster

than the rate of inflation, makes changes to the Medicare Part D program to require manufacturers to bear more liability for certain drug

benefits, which has taken effect in 2025, and includes government price setting for certain Medicare Part D drugs starting in 2026 and

Medicare Part B drugs starting in 2028.

340B Drug Discount Program and legislative changes

The 340B drug discount program (part of the Public Health Service Act)

requires pharmaceutical manufacturers to sell certain outpatient drugs at significantly reduced prices to eligible healthcare providers

known as “covered entities” that serve a large number of low-income patients.

Participation in this program by manufacturers

is often required in exchange for access to the Medicaid market.

false claims and false statement laws, including the federal civil False Claims Act, prohibits, among other things, any person or entity

from knowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid,

claims for items or services, including drugs, that are false or fraudulent or not provided as claimed.

Entities can be held liable under

these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate

billing or coding information to customers, promoting a product off-label, or for providing medically unnecessary services or items.

In addition, activities relating to the sale and marketing of products are subject to scrutiny under this law.

Penalties for the federal

civil False Claims Act violations may include up to three times the actual damages sustained by the government, (commonly referred to

as treble damages), plus mandatory civil penalties for each separate false claim, the potential for exclusion from participation in federal

health care programs, and, although the federal civil False Claims Act is a civil statute, False Claims Act violations may also implicate

various federal criminal statutes.

Payments Sunshine Act

Physician Payments Sunshine Act is a national disclosure program created by the Patient Protection and Affordable Care Act, as amended

by the Health Care and Education Reconciliation Act of 2010 that aims to increase transparency in payments from medical device manufacturers

and pharmaceutical companies to physicians and teaching hospitals.

In 2018, the Substance Use-Disorder Prevention that Promotes Opioid

Recovery and Treatment for Patients and Communities Act expanded these covered recipients to include physician assistants, nurse practitioners,

clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants and certified nurse midwives.

payments in the industry to physicians and other “covered recipients” can include consulting fees, honoraria, fees for training

and education, research fees, gifts, vacations, food and beverage, travel and lodging, charitable contributions, grants, ownership and

investment interests, royalty or license fees, and compensation for serving as faculty or a speaker.

Reduction Act (“IRA”)

IRA, passed by Congress in 2022, makes significant changes to how drugs are covered and paid for under the Medicare Program.

financial penalties for drugs whose prices rise faster than the rate of inflation, makes changes to the Medicare Part D program to require

manufacturers to bear more liability for certain drug benefits, which has taken effect in 2025, and includes government price setting

for certain Medicare Part D drugs starting in 2026 and Medicare Part B drugs starting in 2028.

Drug Discount Program and legislative changes

340B drug discount program (part of the Public Health Service Act) requires pharmaceutical manufacturers to sell certain outpatient drugs

at significantly reduced prices to eligible healthcare providers known as “covered entities” that serve a large number of

low-income patients.

Participation in this program by manufacturers is often required in exchange for access to the Medicaid market.

Privacy and Security Laws

6 unchanged sentences

Technology for Economic and Clinical Health Act, or HITECH.

Among other things, the HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates,” independent contractors

or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of

a covered entity.

HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates

and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal

courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.

Among other things, the HITECH makes HIPAA’s privacy and security standards

directly applicable to “business associates,” independent contractors or agents of covered entities that receive or obtain

protected health information in connection with providing a service on behalf of a covered entity.

HITECH also increased the civil and

criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys

general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s

fees and costs associated with pursuing federal civil actions.

are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

9 unchanged sentences

to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such with, or furnish it

Our code of conduct, Board committee charters, and certain other corporate

governance policies are also posted on the Investor Relations section of our website.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business