What changed in this filing

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Item 1. Business

2021-03-16 compared with 2020-03-05 · 389 added, 418 removed, 320 unchanged (72% of the section changed)

were formed in April 2017 as a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative

pharmaceutical products that fulfill an unmet patient need.

We have successfully built a diversified portfolio of high-value pharmaceutical

products, primarily focused on two categories:

hospital injectable products and pediatric retail prescription products.

plan to achieve our goal of becoming an industry leading innovative pharmaceutical company by executing on the commercialization

of Biorphen®

and continuing to build our product portfolio through internal product development and business development activities.

Our business development activities primarily target product opportunities with the following characteristics:

Time to Market.

We seek out innovative products that are FDA approved, under review with the FDA, or have the potential to

be commercialized within 18 months.

from Competition.

Product protection typically takes the form of Orange Book listed patents and FDA granted exclusivities,

such as orphan drug exclusivity.

Protection can also include challenging to replicate formulations, complex manufacturing, or

difficult to source active pharmaceutical ingredients.

Clinical and Regulatory Risk.

We pursue product candidates where we can leverage existing safety and efficacy data to reduce

the clinical burden required to receive FDA approval, providing for faster and lower cost product approvals.

Typically, our products

require only a single Phase 3 trial, a bioequivalence trial, or literature based clinical data for their New

Drug Application (“NDA”) submissions.

Commercial Risk.

We pursue products that we believe can fulfill a proven unmet need.

This may include opportunities to bring

products to market to address markets that are currently relying on unapproved or compounded products.

currently disclosed product portfolio includes nine products:

one commercial product, three products under review with the FDA,

and five candidates in our late-stage pipeline.

Submission Timing

Product Market Size

Biorphen (Phenylephrine)

(Lamotrigine)

(Levothyroxine)

Pipeline only includes product candidates that Eton expects to submit within twelve months.

Reference product market sizes

based on IQVIA data unless noted.

on management estimates

will be marketed by Bausch Health

(Phenylephrine Hydrochloride Injection) .

Biorphen is the

first and only FDA-approved formulation of ready-to-use phenylephrine injection.

Biorphen in indicated for the treatment of clinically

important hypotension resulting primarily from vasodilation in the setting of anesthesia.

The product was approved in October

2019 and launched in December 2019.

estimate the current market size for ready-to-use phenylephrine to be more than 20 million units of Biorphen annually.

primarily competes with FDA-approved formulations of concentrated phenylephrine injection, which must be diluted prior to administration

to patients, and with unapproved formulations of ready-to-use phenylephrine sold by 503B compounding pharmacies.

are a pharmaceutical company focused on developing, acquiring, and commercializing innovative pharmaceutical products that fulfill

an unmet patient need.

Since the formation of our company in 2017, we have used our expertise in business development, regulatory,

and product development to assemble a diversified portfolio of nine products and product candidates.

All nine of our product

candidates have now been submitted to the U.S.

Food & Drug Administration (“FDA”) and three of them

have been approved and commercially launched.

We plan to continue growing our business through the acquisition of additional late-stage,

high-value product candidates.

product portfolio is comprised of two categories:

Orphan Drugs and Royalty Products.

orphan drug product category is focused on commercializing products that treat the unmet needs of patients suffering from rare

Our first orphan product, Alkindi Sprinkle®, was launched in the fourth quarter of 2020.

As defined by the FDA,

orphan drugs typically address diseases that impact fewer than 200,000 patients in the United States.

Given these small patient

populations, products are typically promoted with small, targeted sales forces and distributed through high-touch specialty pharmacies

that provide comprehensive services to patients or caregivers.

We expect to continue to grow our orphan drug product category

and eventually commercialize multiple products.

We are currently seeking to acquire late-stage orphan drug candidates and expect

to add additional product candidates to our pipeline in the near-future.

Sprinkle ®

We currently commercialize Alkindi Sprinkle in the United States.

The product was approved by the FDA in September

2020 as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.

The product is the first

and only FDA-approved granule hydrocortisone formulation for the treatment of AI designed for use in children.

We launched Alkindi

Sprinkle in December 2020 with a sales force targeting pediatric endocrinologists.

We believe there are approximately 10,000 children

currently suffering from AI in the United States.

Alkindi Sprinkle is protected by four issued patents that extend to 2034.

January 2021, we announced the acquisition of Canadian rights to Alkindi Sprinkle and we expect to pursue regulatory approval

of the product in Canada in the near future.

Alcohol Injection.

Our dehydrated alcohol injection product has been submitted to the FDA for the treatment of methanol

The application has been granted Orphan Drug Designation and is expected to receive seven years of market

exclusivity upon its approval.

We submitted the NDA for the product to the FDA in July 2020, and the application has been

assigned a PDUFA date of May 27, 2021.

royalty products category is comprised of products that Eton does not commercialize or products that do not require promotional

In certain cases, the products may be owned and commercialized by a partner that will pay Eton milestones, royalties,

and/or profit shares from commercial sales.

In other cases, Eton may retain ownership of the product, but the product may not

require promotion or may be commercialized by a co-promotion partner.

royalty products category strategy allows us to monetize our vast experience and talent in business development, regulatory activities,

and product development to generate high returns on our financial investments without being restricted by commercial organization

Specifically, the royalty model allows us to pursue attractive product opportunities in a wide variety of dosage

forms, therapeutic areas, and sales channels without being restricted to only pursue product opportunities that are complementary

to a specific sales infrastructure.

By avoiding the financial and human resources required to commercialize products, we believe

we have created a highly scalable business model that can grow revenue significantly with minimal required growth in overhead

expenses and headcount.

believe our asset sales to Azurity Pharmaceuticals (“Azurity”) and Bausch Health Ireland Limited (“Bausch Health”

) have proven the validity of our business model and have established a successful track record.

We expect the diversified portfolio

of royalty interests that we have assembled to provide significant high-margin revenue to the company for years to come, and we

expect to continue growing our portfolio.

Future royalties may be acquired or created via a number of different strategies, including:

Initiation of development on Eton’s internal product ideas to be licensed out to commercial partners in the future,

licensing of existing development programs where Eton can provide development, regulatory and financial support to advance

the programs and increase the asset’s value before selling or licensing it to a commercial partner, or

acquisition of royalty interests in existing commercial products or development candidates.

current royalty products category includes seven products, two of which have been commercially launched and five

of which are under review with the FDA.

Application Status

Biorphen®

Pharmaceuticals

of Product Profit*

Preservative Free®

Oral Suspension

Pharmaceuticals

May 29, 2021)

Royalty on Net Sales**

Oral Solution

Pharmaceuticals

Royalty on Net Sales**

for Oral Suspension

Pharmaceuticals

Royalty on Net Sales**

Pharmaceuticals

of Product Profit

Ready-to-Use Injection

Pharmaceuticals

(PDUFA Jun 18, 2021)

of Product Profit*

to sales commission/selling costs

also to receive a total of up to $45 million in development and commercial milestones

Prescription Drug User Fee Act Date

Biorphen®.

Biorphen (phenylephrine) is the first and only FDA-approved formulation of ready-to-use phenylephrine injection.

in indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

The product was approved in October 2019 and launched in December 2019.

We estimate the current addressable market for ready-to-use

phenylephrine to be more than ten million units of Biorphen annually.

Biorphen primarily competes with FDA-approved formulations

of concentrated phenylephrine injection, which must be diluted prior to administration to patients, and with unapproved formulations

of ready-to-use phenylephrine sold by 503B compounding pharmacies.

Eton owns the Biorphen new drug application (“NDA”),

but the product is currently promoted by Xellia Pharmaceuticals’

hospital sales force under a co-promotion agreement.

pays Xellia Pharmaceuticals a commission on sales of the product in certain channels.

Eton retains the right to exit the co-promotion

agreement under certain conditions.

We acquired U.S.

marketing rights to the product from Sintetica SA (“Sintetica”) in February 2019.

Under FDA Review:

(Lamotrigine for Oral Suspension) .

ET-105 is our innovative formulation of lamotrigine to be delivered to patients

as an oral suspension.

The NDA for ET-105 has been submitted to the FDA and is under review for the treatment of partial on-set

seizures, primary generalized tonic-clonic seizures, and seizures of Lennox-Gastaut syndrome in patients two year of age and older.

is designed to fulfill an unmet need for patients that require precision dosing or have challenges administering oral solid formulations.

Due to Lamotrigine’s weight-based dosing calculation and the required titration dosing upon initiation of treatment, we

believe there is a significant need for ET-105’s precision dosing.

Currently the lowest strength tablet form of lamotrigine

that is widely available is a 5mg tablet.

ET-105 is designed to allow dosing in increments of 1.0mg.

is currently only approved in oral solid formulations, for which the U.S.

market is currently more than $700 million annually

according to IQVIA data.

We acquired U.S marketing rights to the product from Aucta Pharmaceuticals in June 2019.

Aucta has been

issued a patent on ET-105’s innovative formula, which we expect to be listed in the FDA’s Orange Book upon approval.

ET-105’s NDA is under review with the FDA.

The application has been assigned a Prescription Drug User Fee Act (PDUFA) target

action date of March 17, 2020, however, on February 19, 2020 we disclosed that we received an FDA request for changes to the Dosage

and Administration section of the product’s Prescribing Information to simplify the dosing information for intended users.

The FDA has requested that the company conduct a human factors validation study with the revised labeling to demonstrate that

the intended users can prepare and administer the oral suspension safely and effectively.

The company expects the study and its

final report to be completed and submitted to the FDA in 2020.

(Ketotifen Ophthalmic Solution) .

EM-100 is a preservative-free formulation of ketotifen ophthalmic solution

for the treatment allergic conjunctivitis.

The product is expected to be the first and only preservative-free ophthalmic product

marketing rights to the product in February 2019.

Preservative Free®.

Alaway Preservative Free (ketotifen fumarate) is the first and only preservative-free ophthalmic product

approved for the treatment of allergic conjunctivitis.

EM-100’s preservative-free formulation is designed to deliver an

improved comfort profile to patients compared to currently available ketotifen ophthalmic products that contain preservatives.

EM-100 will be sold via the over-the-counter (OTC) channel.

Currently the market for ketotifen ophthalmic products is estimated

to be more than $75 million annually based on data from IRI and IQVIA.

sold the EM-100 product rights to Bausch Health (“Bausch”) in February 2019.

Bausch Health will be responsible

for commercialization of the product.

We are entitled to receive a $1.5 million milestone payment upon launch of the product and

will receive a double-digit percentage royalty on the product’s net sales.

Bausch received a Complete Response Letter on

the product’s application in July 2019 and responded in an amendment submitted in December 2019.

The product has

been assigned a target action date in August 2020.

DS-300 is an injectable product candidate for which we have submitted an Abbreviated New Drug Application “ANDA”

We originally submitted DS-300 as an NDA under a Rolling Review, however, due to the approval of a competitor’s

NDA containing the same active ingredient, the FDA requested that we resubmit the product as an ANDA.

The ANDA was submitted in

December 2019 and has been accepted for review by the FDA.

We believe we are the first-to-file ANDA and should be entitled

to 180 days of exclusivity if the patent is successfully challenged.

The FDA has assigned the product’s application a target

action date in October 2020, however, expected Paragraph IV challenge litigation will delay final FDA approval beyond that

to the approval of the reference product by a third party in 2019, DS-300’s active ingredient was supplied in injectable

form as an unapproved product.

Based on the IQVIA date for the current market price and historic volumes for the unapproved product,

we believe the market size is more than $65 million annually.

Product Candidates

ET-203 is an innovative ready-to-use formulation of a molecule that is currently approved in a concentrated formulation

that must be diluted prior to administration to patients.

Hospitals currently purchase non-FDA approved ready-to-use products

from compounding facilities, or manually dilute the products in-house.

Our product candidate has been developed in a ready-to-use

strength that can be immediately administered to patients, eliminating the need for calculations and additional dilution

We believe that, if approved, ET-203 will offer significant benefits to hospitals over the current compounded products,

including longer shelf-life, reduction of compounding errors, greater sterility assurance, and more consistent supply.

ET-203’s NDA was originally submitted to the FDA in July 2019 and received a refuse-to-file letter.

Our development partner,

Sintetica, expects to address the FDA’s concerns and resubmit the NDA in 2020.

ET-104 is an innovative oral liquid product candidate targeting a neurological indication.

ET-104’s active ingredient

is approved and marketed in an oral solid formulation, but the active ingredient is not approved by the FDA in liquid form.

patients requiring liquid formulations of the active ingredient are reliant on compounded products or manually crushing tablets

to create liquid solutions.

ET-104 is expected to address this significant unmet patient need.

Our development partner filed a

patent application on its unique formula in March 2019.

We are currently in discussions with the FDA regarding the application’s

pediatric study protocol, and we expect to submit the NDA in 2020.

The current market for ET-104’s active ingredient in

oral solid form is more than $65 million annually according to IQVIA.

ET-103 is a unique oral liquid formulation of levothyroxine for the treatment of hypothyroidism.

Currently levothyroxine is

delivered primarily in tablet and capsule form and is one of the most frequently prescribed medications in the United States with

more than 5.7 billion tablets and $2.6 billion prescribed annually according to IQVIA data.

We are currently in discussions

with the FDA regarding the products bioequivalence data results to ensure compliance with FDA requirements prior to submission

If we receive agreement from the FDA, we expect the product’s NDA to be submitted in the first half of 2020.

DS-100 is an injectable product candidate.

DS-100’s active ingredient was historically sold in injectable form as an

unapproved product, but a third party recently received FDA approval.

Eton is pursuing a different indication than the currently

approved product.

We expect an NDA for DS-100 to be submitted in 2020.

Is an innovative oral liquid product candidate targeting a neurological condition.

ET-101’s active ingredient is approved

and marketed in an oral solid formulation, but the active ingredient is not approved by the FDA in liquid form.

Currently, patients

requiring liquid formulations of the active ingredient are reliant on compounded products.

ET-101 is expected to address this

significant unmet patient need.

Based on IQVIA data, the U.S.

market for ET-101’s active ingredient in oral solid

form is more than $800 million annually.

We are currently running a bioequivalence study for the product and expect to file the

late-stage pipeline only includes product candidates that we believe can be submitted to the FDA within twelve-months.

For competitive

reasons, we typically do not disclose our additional product candidates that are more than twelve months away from NDA submission.

The preservative-free formulation is designed to deliver an improved comfort

profile to patients compared to currently available ketotifen ophthalmic products that contain preservatives.

The product is sold

via the over-the-counter channel.

Currently the market for ketotifen ophthalmic products is estimated to be more than $75

million annually based on data from IRI and IQVIA.

We sold the product rights to Bausch Health in February 2019.

Bausch Health

is responsible for commercialization of the product which was launched in February 2021.

We are entitled to receive a $1.5 million

milestone payment in conjunction with the launch of the product and will receive a double-digit percentage royalty on the product’s

Oral Liquids (Zonisamide, Topiramate, and Lamotrigine).

In 2018 and 2019, we assembled a portfolio of three neurology oral

liquid products through in-licensing and internal development.

All three products are molecules that are widely used in oral solid

forms to treat epilepsy, however, are not currently FDA-approved in liquid formulations.

We believe our formulations will be beneficial

to patients suffering from dysphagia, which is prevalent among pediatric and geriatric patients.

In addition, our liquid formulations

offer precision dosing, which can provide patients and caregivers with accurate doses that are lower than or in between the limited

strength doses available from oral solid products.

advanced all three products to NDA submission, and in February 2021 we announced that we sold the three products to Azurity.

Under terms of the agreement, Azurity will pay us milestone payments of up to $45 million and a single digit royalty on net sales

of the products.

Azurity has taken over ownership of the products and is responsible for all development, regulatory, and commercial

Oral Suspension .

The product is an innovative liquid formulation of zonisamide under FDA review for the treatment of partial

seizures in patients with epilepsy.

The product has been issued a patent, which is now owned by Azurity.

The product’s

NDA has been assigned a PDUFA date of May 29, 2021.

The current market for zonisamide in oral form is more than $65 million annually

according to IQVIA.

Oral Solution .

The product is an innovative liquid formulation of topiramate under FDA review for three indications, including:

monotherapy for treatment of partial-onset or primary general tonic-clonic seizures in patients two years of age and older;

therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two year

of age and older;

and as a preventive treatment of migraine in patients 12 years of age and older.

Eton’s development partner

has submitted a patent on the product.

The product’s NDA has been assigned a PDUFA date of August 6, 2021.

The current market

for topiramate in oral form is more than $800 million annually according to IQVIA.

for Oral Suspension.

The product is an innovative liquid formulation of lamotrigine under FDA review for the treatment of

partial on-set seizures, primary generalized tonic-clonic seizures, and seizures of Lennox-Gastaut syndrome in patients two year

of age and older.

The product has been issued a patent, which is now owned by Azurity.

The product’s NDA

application received a Complete Response Letter in March 2020 and the FDA requested changes to the Dosage and Administration section

of the product’s Prescribing Information to simplify the dosing information for intended users.

The FDA has requested a

human factors validation study with the revised labeling to demonstrate that the intended users can prepare and administer the

oral suspension safely and effectively.

Our development partner is in the process of completing the study and expects the final

report to be completed and submitted to the FDA in 2021.

The current market for lamotrigine in oral form is more than $700 million

annually according to IQVIA.

Cysteine injection is a product candidate for which we have submitted an Abbreviated New Drug Application (“ANDA”)

We believe we are the first-to-file ANDA and should be entitled to 180 days of exclusivity if the patent is successfully

We expect the NDA to receive tentative approval, in 2021 however, ongoing Paragraph IV

litigation is expected to delay final FDA approval beyond that date.

We believe the current market for Cysteine injection is more

than $50 million annually.

Ready-to-Use Injection.

This product is an innovative ready-to-use formulation of a molecule that is currently approved in

a concentrated formulation that must be diluted prior to administration to patients.

Hospitals currently purchase non-FDA approved

ready-to-use products from compounding facilities, or manually dilute the products in-house.

Our product candidate has been developed

in a ready-to-use strength that can be immediately administered to patients, eliminating the need for calculations and additional

dilution steps.

We believe that, if approved, our product will offer significant benefits to hospitals over the current compounded

products, including longer shelf-life, reduction of compounding errors, greater sterility assurance, and more consistent supply.

Our development partner, Sintetica, has submitted the product’s NDA and the application has been assigned a PDUFA date of

June 18, 2021.

and Strengths

goal is to become a leading specialty pharmaceutical company through the introduction of innovative medicines that are affordable

and available to all patients.

We believe our competitive strengths include our:

knowledge of the industry, including our ability to identify product opportunities;

management’s

regulatory and development experience, particularly within the 505(b)(2) pathway;

portfolio of attractive assets that we believe will enable us to compete effectively in the market;

management’s

experience in business development, M&A, licensing activities and broad industry connections;

differentiated

business model as compared to generic and branded specialty pharmaceutical drug companies, utilizing the 505(b)(2) pathway;

rights, know-how, exclusive API and manufacturing relationships.

goal is to become a leading profitable pharmaceutical company that brings innovative treatments to patients.

We believe we are

unique in the pharmaceutical industry in our ability to identify, acquire, and advance products through the development and regulatory

Our biggest competitive strengths are:

development experience–

our ability to identify and execute transactions on under-appreciated development assets.

team has completed over 150 business development transactions throughout their careers and their industry connections and

track record provide the company with proprietary deal flow.

We avoid participating in broker led transactions of auction

expertise –

Our knowledge and experience gaining FDA approval, and particularly our knowledge within the 505(b)(2) regulatory

pathway, which provides drug sponsors with the opportunity to leverage existing data or literature to drastically expedite

drug development timelines and reduce investment.

and Marketing

We currently commercialize

Biorphen with the support of a co-promotion agreement with Xellia Pharmaceuticals.

We intend to commercialize most of our products

through our internal sales and marketing infrastructure.

However, in certain scenarios we may conclude that it is financially

or strategically beneficial to out-license, sell, or partner with a third party for commercialization of a product.

we sold our EM-100 product candidate to Bausch Health, who has an established presence in the over-the-counter ophthalmic channel,

in exchange for milestone payments and future royalty payments based on Bausch’s sales of the product.

products primarily fall into two categories for commercialization:

Hospital injectables and retail prescription products.

injectables products are primarily marketed to hospitals and surgical centers and may be purchased by customers through wholesalers

and/or arrangements with Group Purchasing Organizations (GPOs).

Our first product launch in this category was Biorphen in December

2019, and our additional hospital injectable products include DS-300, ET-203, and DS-100.

January 2020 we signed a co-promotion agreement with Xellia for the promotion of Biorphen.

Under terms of the agreement, Xellia’s

US-based hospital sales force will promote Biorphen in certain customer channels in collaboration with Eton, in exchange for a

commission based on net sales realized at certain customer accounts.

The product will continue to be sold under Eton’s brand

name, and Eton has the right to continue promoting the product to all customer accounts.

The agreement has a five-year term, but

allows Eton to exit under various scenarios, including a change of control, and after 2021 if Biorphen net sales from Xellia designated

accounts do not exceed $29.4 million in 2021, or $42.0 million in 2022 and the following years.

retail prescription products will be promoted to prescribing physicians, primarily neurologists and endocrinologists.

to distribute the products through a network of retail and specialty pharmacies.

Our products in this category include ET-105,

ET-104, ET-103 and ET-101.

currently own or have economic interests in three commercial products.

We plan to commercialize our orphan products internally

with our own infrastructure.

For our royalty category products, we plan to utilize partners for any product commercialization

that requires promotional activities.

In our orphan product category, we currently commercialize Alkindi Sprinkle in the United

We believe we have established the internal infrastructure necessary to commercialize the product.

We have an internal

field sales force targeting pediatric endocrinologists and may utilize third-party companies for additional promotional activities.

The product is distributed to patients via a specialty pharmacy, which supports customer service and reimbursement activities.

our royalty product category, we rely on partners to commercialize Alaway Preservative Free and Biorphen.

We sold Alaway Preservative

Free (previously known as EM-100) to Bausch Health in February 2019, and Bausch Health is responsible for all commercialization

Eton receives a royalty on net sales of the product.

January 2020 we signed a co-promotion agreement with Xellia Pharmaceuticals for the promotion of Biorphen.

Under terms of the

agreement, Xellia’s US-based hospital sales force will promote Biorphen in certain customer channels in exchange for a commission

based on net sales realized at certain customer accounts.

Eton owns the Biorphen NDA and the product is sold under Eton’s

The agreement has a five-year term, but allows Eton to exit under various scenarios, including a change of control,

and after 2021 if Biorphen net sales from Xellia designated accounts do not exceed $29.4 million in 2021, or $42.0 million in

2022 and the following years.

and Development

currently have ten employees that support research and development and have a laboratory facility that supports product

development and testing.

In addition, we utilize external sources for various product development activities including the

resources of our product development partners for certain product candidates and also through the use of contract laboratory

services on a fee for service model.

currently have six employees that support research and development and have a laboratory facility that supports product development

In addition, we utilize external sources for various product development activities including the resources of our

product development partners for certain product candidates and also through the use of contract laboratory services on a fee

for service model.

Manufacturing

1 unchanged sentence

rely on third-party contract manufacturing organizations (“CMOs”) to manufacture our products.

manufacturing partners are based in the United States or Europe.

We seek to work with CMOs that have a long history of

quality and FDA compliance.

All products are manufactured in compliance with current Good Manufacturing Processes

(“cGMP”), and our internal quality system requires us to enter quality agreements with and audit all of our

manufacturers prior to commercializing product.

Our choice to rely on external manufacturers significantly reduces the amount

of capital invested in our business and allows us the flexibility to pursue a broad range of opportunities beyond the

specific capabilities of a single facility.

products in our portfolio were acquired externally through the licensing or acquisition of existing development products including:

We acquired the exclusive license to market Biorphen in the United States pursuant to an Exclusive License and Supply

Agreement dated February 8, 2019 between us and Sintetica.

Pursuant to the terms of the agreement, we will be responsible for

marketing activities and Sintetica will be responsible for development, manufacturing, and regulatory activities related to obtaining

regulatory approval.

We paid Sintetica a licensing payment of $2 million upon execution of the agreement and paid an additional

$750,000 upon commercial launch of the product.

Sintetica supplies product to us at its direct costs.

We retain 5% of net sales

as a marketing fee.

Sintetica receives the first $500,000 of product profits, and all additional profit will be split 50%

to us and 50% to Sintetica.

The agreement has a 10-year term from first commercial sale of product.

On June 12, 2019, we entered into an Exclusive Licensing and Supply Agreement (the “ET-105 License Agreement”)

with Aucta Pharmaceuticals, Inc.

(“Aucta”) for marketing rights in the United States to ET-105.

the terms of the ET-105 License Agreement, we will be responsible for marketing activities and Aucta will be responsible

for development, manufacturing, and regulatory activities related to obtaining regulatory approval.

We paid Aucta a licensing

payment of $2,000,000 in August 2019 upon receiving an acceptance for review letter from the FDA and will pay $2,000,000 upon

FDA approval and the commencement of commercial sales of the product and another $1,000,000 upon issuance of an Orange-book

listed patent.

Aucta will receive a low double-digit royalty on net sales and will be entitled to receive additional milestone

payments of up to $18,000,000 in total based on commercial success of the product, including:

$1,000,000 when net sales

exceed $10 million in a calendar year;

$2,000,000 when net sales exceed $20 million in a calendar year;

$5,000,000 when net sales

exceed $50 million in a calendar year;

and $10,000,000 when net sales exceed $100 million in a calendar year.

We acquired the exclusive rights to develop, manufacture and sell the EM-100 product in the United States pursuant to a Sales

and Marketing Agreement dated August 11, 2017 between us and Eyemax LLC (“Eyemax”), an entity affiliated with our

Chief Executive Officer (the “Sales Agreement”).

On February 18, 2019, we entered into an Amended and Restated Agreement

(the “Amended Agreement”) with Eyemax amending the Sales Agreement.

Pursuant to the Amended Agreement, Eyemax sold

us all of its right, title and interest in EM-100, including any such product that incorporates or utilizes Eyemax’s intellectual

property rights.

Pursuant to the Amended Agreement, we remain obligated to pay Eyemax two milestones:

(i) one milestone payment

for $250,000 upon regulatory approval in the territory by the FDA of the first single agent product and (ii) one milestone payment

for $500,000 following the first commercial sale of the first single agent product in the territory.

Following payment of the

milestones, we are entitled to retain all of the non-royalty transaction revenues and royalties up to $2,000,000 (the “Recovery

Amount”).

After we have retained the full Recovery Amount, we are entitled to retain half of all royalty and non-royalty

transaction revenue.

February 18, 2019, we entered into an Asset Purchase Agreement with Bausch.

Pursuant to the Asset Purchase Agreement, we sold

all of our right, title and interest in EM-100 in the United States, including any such product that incorporates or utilizes

our intellectual property rights with respect to EM-100.

Pursuant to the Asset Purchase Agreement, Bausch paid us an upfront payment

of $500,000 and Bausch is required to pay us a milestone payment of $1,500,000 upon the first sale of the product.

Bausch is required

to pay us a royalty in the low-double digit percentage range on net sales for a period of 10 years from the date of the first

commercial sale of the first single agent EM-100 product in the United States.

In the event that any product with the same sole

active pharmaceutical ingredient (“API”) as EM-100 is launched in the United States by any person other than

Bausch (or its affiliates) during the term of Bausch’s royalty commitment, then the royalty rate will be reduced to a lower

specified percentage.

In the event that EM-100’s market share in the territory falls below a certain percentage of the target

market during the term of Bausch’s royalty commitment, then the royalty rate will be further reduced to a lower specified

We acquired the exclusive license to develop, manufacture and sell ET-103 in the United States pursuant to an Exclusive License

and Supply Agreement dated August 3, 2018 between us and Liqmeds Worldwide Limited, an unaffiliated entity.

Pursuant to the agreement,

we will be responsible for, and shall own, all regulatory filings and approvals at our expense, provided that we shall have the

right to recoup 35% of any regulatory filing fees from the initial profits from the sale of ET-103 and, provided further, the

licensor shall be responsible for any bioequivalence study and shall be responsible for 60% of the costs of such study.

of the licensor shall manufacture the ET-103 and sell it to us at its cost.

We paid the licensor $350,000 upon execution of the

agreement and will pay the licensor $1,500,000 upon the FDA’s acceptance of an NDA for review, $1,000,000 upon FDA approval,

$1,500,000 upon issuance of patent covering ET-103 listed in the FDA’s Orange Book and $500,000 in the event of product

sales in excess of $10,000,000 in any calendar year.

In addition, we are required to pay the licensor 35% of the net profit from

product sales.

The license agreement is for an initial term of ten years from the date of the first commercial sale of the product,

subject to two-year renewals unless either party elects to terminate no less than 12 months prior to the then current term.

We acquired the exclusive rights to develop, manufacture and sell the DS-300 product in the United States pursuant to a Sales

and Marketing Agreement dated November 17, 2017, as amended on August 29, 2018, with an unaffiliated third party.

the agreement, the licensor is responsible for obtaining FDA approval, at its expense, and we are responsible for commercializing

the product in the United States, at our expense.

The agreement has a term of ten years from the date of the first commercial

sale of the DS-300, subject to one five-year extension at our option.

The licensor may terminate the agreement if we choose not

to launch the DS-300, for commercial reasons only, within three months after FDA approval or if during the first calendar year

following the first commercial sale of the DS-300 net sales of the product do not exceed $1 million.

The agreement also contains

customary representations, warranties, covenants and indemnities by the parties.

In February 2020, we executed an amendment to

the Sales and Marketing Agreement.

Under the revised terms, Eton will be responsible for Paragraph IV related litigation

and will be entitled to 62.5% of product profit, generally defined as gross profit less certain fees and costs incurred by

We acquired the exclusive rights to develop, manufacture and sell the DS-100 product in the United States pursuant to an Exclusive

Development and Supply Agreement dated July 9, 2017 between us and Andersen Pharma, LLC, an entity affiliated with our Chief Executive

We also hold an option to purchase the DS-100 product and all related intellectual property and government approvals.

Pursuant to the agreement, the licensor is responsible for obtaining FDA approval at its expense and manufacturing the product

for sale to us at its cost, however we are responsible for the advancement of the FDA submission fees, which we have the right

to recoup from the initial profits from product sales prior to any profit split.

We are responsible for commercializing the product

in the United States at our expense.

We paid the licensor $750,000 upon execution of the agreement and will pay the licensor $750,000

upon successful completion of a registration batch of product, $750,000 upon submission of an NDA and $750,000 upon FDA approval.

We will also pay the licensor 50% of the net profit from the sale of the product.

The license agreement is for an initial term

of five years from the first commercial sale of the product, subject to successive two-year renewals unless either party elects

to terminate the agreement.

The agreement also contains customary representations, warranties, covenants and indemnities by the

We acquired the exclusive license to sell ET-104 in the United States pursuant to an Exclusive License and Supply Agreement

dated January 23, 2019 between us and Liqmeds Worldwide Limited.

Pursuant to the agreement, we will be responsible for regulatory

and marketing activities.

We paid the licensor $350,000 upon execution of the agreement and will pay the licensor additional milestones

of up to $2.15 million based on the achievement of certain development and commercial milestones.

In addition, we are required

to pay the licensor 35% of the net profit from product sales.

The agreement is for an initial term of 10 years from the date of

the first commercial sale of the product, and we will retain sole ownership after expiration of the agreement.

We acquired the exclusive license to market ET-203 pursuant to an Exclusive License and Supply Agreement dated February 8,

2019 between us and Sintetica.

Pursuant to the terms of the agreement, we will be responsible for marketing activities and Sintetica

will be responsible for development, manufacturing, and regulatory activities related to obtaining regulatory approval.

Sintetica a licensing payment of $1 million upon execution of the agreement and will pay an additional $750,000 upon FDA approval

of the product candidate.

Upon approval, Sintetica will supply ET-203 to us at its direct costs.

We will retain 5% of net sales

as a marketing fee.

Sintetica will be entitled to receive the first $500,000 of product profits.

All additional profit will be

split 50% to us and 50% to Sintetica.

The agreement has a 10-year term from first commercial sale of product.

In January of 2020,

we amended the agreement as a result of the product’s initial new drug application receiving a refuse to file letter

from the FDA, Eton was returned the initial $1 million licensing payment that we paid to Sintetica upon execution of the

original agreement.

If Sintetica resubmits the product NDA and the FDA accepts it for review, Eton will repay the $1 million licensing

All our manufacturing

partners are based in the United States or Europe.

We seek to work with CMOs that have a long history of quality and FDA compliance.

All products are manufactured in compliance with current Good Manufacturing Processes (“cGMP”), and our internal quality

system requires us to enter quality agreements with and audit all of our manufacturers prior to commercializing product.

to rely on external manufacturers significantly reduces the amount of capital invested in our business and allows us the flexibility

to pursue a broad range of opportunities beyond the specific capabilities of a single facility.

policy is to seek to protect our proprietary position by, among other methods, filing U.S.

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not dependent, however, upon any single patent, trademark or contract.

development partner has filed a patent application for ET-104.

We intend to seek patent protection on our internally developed

products as circumstances warrant.

development partner for ET-105 was granted a patent by the United States Patent and Trademark Office for the product’s

unique formulation.

We expect the patent to be Orange Book listed after product approval.

have applied for trademark registration of the marks “Eton”

Alkindi Sprinkle is

protected by four issued patents that extend to 2034.

We intend to seek patent protection on our internally developed products

as circumstances warrant and we have applied for trademark registration of the marks “Eton”

and “Eton Pharmaceuticals”

with the U.S.

and Trademark Office.

Patent and Trademark Office.

Our development partners

for zonisamide and topiramate have filed patent applications on those products and our development partner for lamotrigine was

granted a patent by the United States Patent and Trademark Office for the product’s unique formulation.

We expect the lamotrigine

patent to be Orange Book listed after product approval.

These patents were assigned to Azurity in February 2021.

Regulations and Funding

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trials must be conducted in accordance with the FDA’s good clinical practices (“GCP”) requirements.

FDA may order the temporary or permanent discontinuation of a clinical study at any time or impose other sanctions if it believes

may order the temporary or permanent discontinuation of a clinical study at any time or impose other sanctions if it believes

that the clinical study is not being conducted in accordance with FDA requirements or that the participants are being exposed

to an unacceptable health risk.

An institutional review board (“IRB”) generally must approve the clinical trial

design and patient informed consent at study sites that the IRB oversees and also may halt a study, either temporarily or permanently,

An institutional review board (“IRB”) generally must approve the clinical trial design

and patient informed consent at study sites that the IRB oversees and also may halt a study, either temporarily or permanently,

for failure to comply with the IRB’s requirements, or may impose other conditions.

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Under the Prescription Drug User Fee Act

(“PDUFA”) the FDA’s goal is to complete its initial review and respond to the applicant within ten months

of submission, unless the application relates to an unmet medical need, or is for a serious or life-threatening indication, in

which case the goal may be within six months of NDA submission.

However, the review process and the target response date under

PDUFA may be extended if the FDA requests or the NDA sponsor otherwise provides additional information or clarification regarding

information already provided in the NDA.

During its review of an NDA, the FDA may refer the application to an advisory committee

for review, evaluation and recommendation as to whether the application should be approved.

The FDA is not bound by the recommendation

of an advisory committee, but it typically follows such recommendations.

Data from clinical studies are not always conclusive

and the FDA and/or any advisory committee it appoints may interpret data differently than the applicant.

(“PDUFA”) the FDA’s goal is to complete its initial review and respond to the applicant within ten months of

submission, unless the application relates to an unmet medical need, or is for a serious or life-threatening indication, in which

case the goal may be within six months of NDA submission.

However, the review process and the target response date under PDUFA

may be extended if the FDA requests or the NDA sponsor otherwise provides additional information or clarification regarding information

already provided in the NDA.

During its review of an NDA, the FDA may refer the application to an advisory committee for review,

evaluation and recommendation as to whether the application should be approved.

The FDA is not bound by the recommendation of

an advisory committee, but it typically follows such recommendations.

Data from clinical studies are not always conclusive and

the FDA and/or any advisory committee it appoints may interpret data differently than the applicant.

the FDA evaluates the NDA and inspects manufacturing facilities where the drug product and/or its API will be produced, it will

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The FDA could also

approve the NDA with a Risk Evaluation and Mitigation Strategies (“REMS”) plan to mitigate risks, which could

include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods,

patient registries and other risk minimization tools.

approve the NDA with a Risk Evaluation and Mitigation Strategies (“REMS”) plan to mitigate risks, which could include

medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient

registries and other risk minimization tools.

The FDA also may condition approval on, among other things, changes to proposed

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505(b)(2) New Drug Applications

We intend to submit

applications for certain product candidates via the 505(b)(2) regulatory pathway.

As an alternate path for FDA approval of new

indications or new formulations of previously approved products, a company may submit a Section 505(b)(2) NDA, instead of a “stand-alone”

intend to submit applications for certain product candidates via the 505(b)(2) regulatory pathway.

As an alternate path for FDA

approval of new indications or new formulations of previously approved products, a company may submit a Section 505(b)(2) NDA,

instead of a “stand-alone”

or “full”

Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (“FDCA”) was enacted

as part of the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Amendments.

Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval comes from studies

not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

Some examples of products

that may be allowed to follow a 505(b)(2) path to approval are drugs that have a new dosage form, strength, route of administration,

formulation or indication.

Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act

(“FDCA”) was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known

as the Hatch-Waxman Amendments.

Section 505(b)(2) permits the submission of an NDA where at least some of the information required

for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of

Some examples of products that may be allowed to follow a 505(b)(2) path to approval are drugs that have a new dosage

form, strength, route of administration, formulation or indication.

Hatch-Waxman Amendments permit the applicant to rely upon certain published nonclinical or clinical studies conducted for an approved

140 unchanged sentences

of the provisions of the Health Care Reform Law have yet to be implemented, and there have been judicial and Congressional challenges

to certain aspects of the Health Care Reform Law, as well as recent efforts by the Trump administration to repeal or replace certain

aspects of the Health Care Reform Law.

Since January 2017, President Trump has signed two executive orders and other directives

designed to delay, circumvent or loosen certain requirements mandated by the Health Care Reform Law.

Concurrently, Congress has

considered legislation that would repeal or repeal and replace all or part of the Health Care Reform Law.

While Congress has not

passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the Health Care Reform

Law have been signed into law.

The Tax Cuts and Jobs Act of 2017 (the “Tax Act”) included a provision which repealed,

effective January 1, 2019, the tax-based shared responsibility payment imposed by the Health Care Reform Law on certain individuals

who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual

to certain aspects of the Health Care Reform Law, as well as recent efforts by the former Trump administration to repeal or replace

certain aspects of the Health Care Reform Law.

Since January 2017, former President Trump had signed two executive orders and

other directives designed to delay, circumvent or loosen certain requirements mandated by the Health Care Reform Law.

Concurrently,

Congress has considered legislation that would repeal or repeal and replace all or part of the Health Care Reform Law.

While Congress

has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the Health Care

Reform Law have been signed into law.

The Tax Cuts and Jobs Act of 2017 (the “Tax Act”) included a provision which

repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the Health Care Reform Law on certain

individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual

mandate.”

On January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that

delayed the implementation of certain Health Care Reform Law-mandated fees, including the so-called “Cadillac”

on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on

market share, and the medical device excise tax on non-exempt medical devices.

On January 22, 2018, former President Trump signed a continuing resolution on appropriations for fiscal year 2018

that delayed the implementation of certain Health Care Reform Law-mandated fees, including the so-called “Cadillac”

tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based

on market share, and the medical device excise tax on non-exempt medical devices.

The Bipartisan Budget Act of 2018, among other

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costs of drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of

certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of

pocket costs of drug products paid by consumers.

On January 31, 2019, the Health and Human Services (“HHS”)

Office of Inspector General proposed modifications to the U.S.

Anti-Kickback Statute discount safe harbor for the purpose of reducing

the cost of drug products to consumers which, among other things, if finalized, will affect discounts paid by manufacturers to

Medicare Part D plans, Medicaid managed care organizations and pharmacy benefit managers working with these organizations.

some of these and other proposed measures may require additional authorization to become effective, Congress and the Trump administration

have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.

certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out-of-pocket

costs of drug products paid by consumers.

On January 31, 2019, the Health and Human Services (“HHS”) Office of Inspector

General proposed modifications to the U.S.

Anti-Kickback Statute discount safe harbor for the purpose of reducing the cost of

drug products to consumers which, among other things, if finalized, will affect discounts paid by manufacturers to Medicare Part

D plans, Medicaid managed care organizations and pharmacy benefit managers working with these organizations.

While some of these

and other proposed measures may require additional authorization to become effective, Congress and government administration officials

have each indicated that they will continue to seek new legislative and/or administrative measures to control drug costs.

in December 2016, the 21st Century Cures Act was signed into law.

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and review and approval of marketing applications.

currently have 17 full-time employees, ten of whom are engaged in research and development activities and seven of whom are engaged

in general corporate and strategy roles.

We periodically utilize outside consultants on an as-needed basis, including medical

currently have 16 full-time employees, six of whom are engaged in research and development activities, six are engaged in sales/marketing

operations and four of whom are engaged in general corporate and strategy roles.

We periodically utilize outside consultants on

an as-needed basis, including medical consultants and product telesales services.

and Other Information

were incorporated under the laws of the state of Delaware in April 2017.

We were initially a wholly owned subsidiary of Harrow

(“Harrow”) but are no longer a subsidiary of Harrow.

Our principal executive offices are located at 21925

Field Parkway, Suite 235, Deer Park, Illinois, 60010, and our telephone number is (847) 787-7361.

Our corporate website

address is www.etonpharma.com, to which we regularly post copies of our press releases as well as links to reports we have filed

with the SEC, which are available free of charge as soon as reasonably practicable after being electronically filed with or furnished

Our corporate website address

is www.etonpharma.com, to which we regularly post copies of our press releases as well as links to reports we have filed with

the SEC, which are available free of charge as soon as reasonably practicable after being electronically filed with or furnished

Interested persons can subscribe on our website to email alerts that are sent automatically when we issues press releases,

9 unchanged sentences

as any indication that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

should carefully consider the risks set forth in the section of this prospectus entitled “Risk Factors”

on page 16 of this Annual Report, including, but not limited to, the following:

are a specialty pharmaceutical company with a limited operating history, and it is difficult for potential investors to evaluate

our business.

business is adversely affected by the ongoing coronavirus pandemic and the impact could be material.

may have significant research, regulatory and development expenses as we advance our product candidates.

may need to grow the size of our organization, and we may experience difficulties in managing this growth.

product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization

of our product candidates.

may acquire businesses or products, or form strategic alliances, in the future, and we may not realize the benefits of such

acquisitions.

rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology,

including any cybersecurity incidents, could harm our ability to operate our business effectively.

of counterfeits of any of our product candidates, as well as unauthorized sales of any of our product candidates, may have

adverse effects on our revenues, business and results of operations and damage our brand and reputation.

have entered into several arrangements with related parties for the development and marketing of certain product candidates

and these arrangements present potential conflicts of interest.

depend entirely on the success of Biorphen and our product candidates.

If we are unable to generate revenues from our product

candidates, our ability to create stockholder value will be limited.

face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to

compete effectively.

competitors may obtain FDA or other regulatory approval for comparable products more rapidly than we may obtain approval for

ours, and the risk of our competitors doing so may lead us to develop drug candidates without disclosing certain information

with regard to such candidates.

we are not able to obtain any required regulatory approvals for our product candidates, we will not be able to commercialize

our product candidate and our ability to generate revenue will be limited.

the FDA does not conclude that our product candidates satisfy the requirements for the 505(b)(2) regulatory approval pathway,

or if the requirements for approval of any of our product candidates under Section 505(b)(2) are not as we expect, the approval

pathway for our product candidates will likely take significantly longer, cost significantly more and encounter significantly

greater complications and risks than anticipated, and in any case may not be successful.

NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that

would delay or prevent the review or approval of our product candidate.

if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the

product, and the revenue that we generate from its sales, if any, may be limited.

are subject to ongoing obligations and continued regulatory review, which may result in significant additional expense.

Additionally,

our product candidates could be subject to labeling and other restrictions and withdrawal from the market and we may be subject

to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product

additional labeling or warning requirements or limitations on the availability of our products may inhibit sales of affected

and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product

candidates and affect the prices we may obtain.

future growth may depend, in part, on our ability to penetrate international markets, where we would be subject to additional

regulatory burdens and other risks and uncertainties.

we market Biorphen or any of our product candidates in a manner that violates health care fraud and abuse laws, or if we violate

government price reporting laws, we may be subject to civil or criminal penalties.

may not be able to establish agreements with third parties with whom we wish to collaborate and, if we are able to establish

them, we may not be able to establish them on commercially reasonable terms, which could result in alterations or delays of

our development and commercialization plans.

expect to rely on third parties to conduct clinical trials for our product candidates.

If these third parties do not successfully

carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize

any of our product candidates and our business would be substantially harmed.

enter into various contracts in the normal course of our business, some or all of which may require us to indemnify the other

party to the contract.

In the event we have to perform under these indemnification provisions, it could have an adverse effect

on our business, financial condition and results of operations.

Chief Executive Officer holds ownership interest in some of the third parties we have entered into agreements with.

and fee arrangements of these agreements, we believe, approximate the terms and fee arrangements of an agreement that would

have been obtained in an arm’s length and unaffiliated transaction.

Nonetheless, this may expose us to claims of interested

transactions and other fiduciary suits.

termination or suspension of, or delays in the commencement or completion of, any necessary studies of any of our product

candidates for any indications could result in increased costs to us, delay or limit our ability to generate revenue and adversely

affect our commercial prospects.

drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials

may not be predictive of future trial results.

coverage and reimbursement and health care cost containment initiatives and treatment guidelines may constrain our future

are subject to extensive laws and regulations related to data privacy, and our failure to comply with these laws and regulations

could harm our business.

will depend on rights to certain pharmaceutical compounds that have been acquired by us.

We do not have complete control over

these pharmaceutical compounds and any loss of our rights to them could prevent us from selling our products.

is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights.

may not be able to protect our intellectual property rights throughout the world.

in either U.S.

or foreign patent law or interpretation of such laws could diminish the value of patents in general, thereby

impairing our ability to protect our products.

product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent

our development and commercialization efforts.

may claim an ownership interest in our intellectual property, which could expose us to litigation and have an adverse effect

on our prospects.

may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully

used or disclosed alleged confidential information or trade secrets of their former employers.

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