What changed in this filing

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Item 1. Business

2023-03-31 compared with 2022-03-30 · 101 added, 97 removed, 257 unchanged (44% of the section changed)

3 unchanged sentences

The Company provides Gamma Knife services through its 81% indirect interest in GK Financing, LLC, a California limited liability company (“GKF”).

The remaining 19% of GKF is owned by GKV Investments, Inc., a wholly-owned U.S.

The remaining 19% of GKF is owned by GKV Investments, Inc.

(“GKV Investments”), a wholly-owned U.S.

subsidiary of Elekta AG, a Swedish company (“Elekta”).

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GKF has established the wholly-owned subsidiaries Instituto de Gamma Knife del Pacifico S.A.C.

(“GKPeru”) and HoldCo GKC S.A (“HoldCo”) for the purpose of providing similar Gamma Knife services in Peru and Ecuador, respectively.

HoldCo owns approximately 99.3% of the total outstanding shares of Gamma Knife Center Ecuador S.A.

(“GKCE”).

GKF also owns a 51% interest in Albuquerque GK Equipment, LLC (“AGKE”) and Jacksonville GK Equipment, LLC (“JGKE”).

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LBE is not expected to generate revenue within the next two years.

On June 12, 2020, GKF, through HoldCo, purchased approximately 98% of the total outstanding shares of Gamma Knife Center Ecuador S.A.

(“GKCE”), from GKCE’s majority shareholders (the “Acquisition”).

Subsequent to the Acquisition, the Company acquired additional shares that increased its ownership to approximately 99.3% of the total outstanding shares of GKCE and intends to acquire the remaining 0.7% at a later date.

The base purchase price for the Acquisition, including acquisition of the minority shares was approximately $2,000,000.

This purchase price was paid with $575,000 in cash and a $1,425,000 loan (the “DFC Loan”) from the United States International Development Finance Corporation (“DFC”).

The purchase price was subject to certain post-closing adjustments, including adjustment for GKCE's working capital and excess cash.

The DFC Loan is denominated in U.S.

dollars, which is also the currency of Ecuador. 

See Note 5 - GKCE Acquisition for additional information regarding the Acquisition.

On April 27, 2022 ,  the Company signed a Joint Venture Agreement (the “Agreement”) with the principal owners of Guadalupe Amor Y Bien (“Guadalupe”) to establish AB Radiocirugia Y Radioterapia de Puebla, S.A.P.I.

of Puebla (“Puebla”) to treat public- and private-paying cancer patients.

The Company and Guadalupe will hold 85% and 15% ownership interests, respectively, in Puebla.

Under the Agreement, the Company will be responsible for providing a linear accelerator upgrade to an Elekta Versa HD, and Guadalupe will be accountable for all site modification costs. 

The Company formed ASHS-Mexico, S.A.

on October 3, 2022 to establish Puebla in order to provide radiation therapy and radiosurgery services locally in Mexico. 

Puebla was formed on December 15, 2022.

The Company continues to develop its design and business model for “The Operating Room for the 21st Century”SM through its 50% owned OR21, LLC (“OR21”).

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In 2015, Elekta introduced an upgrade to the Gamma Knife Perfexion unit called Icon.

In 2022, Elekta introduced an upgrade to the Icon, called the Esprit.

As of March 1, 2023, all of the Company’s twelve Gamma Knife units in the United States are Gamma Knife Perfexion units and two of these Perfexion units have the Icon upgrade. 

The Company’s Gamma Knife units in Peru and Ecuador are Model 4(C)s. 

The Company expects to replace the unit in Ecuador with an Icon in the third quarter of 2022.

The Company expects to replace the unit in Ecuador with an Icon in mid-2023.

The Gamma Knife treats selected malignant and benign brain tumors, arteriovenous malformations, and functional disorders including trigeminal neuralgia (facial pain).

As of December 31, 2021, there were approximately 115  Gamma Knife sites in the United States and 352  units in operation worldwide.

Based on 2019 case mix data, an estimated percentage breakdown of Gamma Knife procedures performed in the U.S.

As of December 31, 2022 , there were 118 Gamma Knife sites in the United States and 360 units in operation worldwide.

Based on 2021 case mix data, an estimated percentage breakdown of Gamma Knife procedures performed in the U.S.

by indications treated is as follows:

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The Company’s Gamma Knife units performed 1,286 procedures in 2022 for a cumulative total of approximately 46,200 procedures from commencement through December 31, 2022.

The Company reviews the carrying value of its long-lived assets for impairment on a quarterly basis, or as events or circumstances might indicate that the carrying value may not be recoverable.

The Company has reviewed its Gamma Knife equipment, in light of available information as of December 31, 2021 and concluded no impairment exists. 

As of December 31, 2020, based on current customer prospects, the probability of future contract extensions or renewals, and the high turnover rate in contract terminations compared to the Company's historical contract termination rate, the Company determined that six Gamma Knife units were more-than temporarily impaired.

As of December 31, 2020, the Company recognized a loss on the write down of impaired assets of $8,264,000.

The impaired assets included six Gamma Knife units and related removal costs, and two deposits towards the purchase of proton beam systems and related capitalized interest.

The six Gamma Knife units that were impaired consisted of two units that had been taken out of service in prior years, one unit that was taken out of service in 2020 and three units that have already, or the Company anticipated would be taken out of service in 2021, totaling $3,051,000.

In addition to this impairment write-off of $3,051,000 were estimated costs of de-install and removal, which constitute an 

asset retirement obligation (“ARO”), of four of the Gamma Knife units of $1,350,000 (of which, the Company paid $80,000) as of December 31, 2020.

Total impairment related to the Gamma Knife business was $4,401,000 for the year ended December 31, 2020. As of December 31, 2021, the Company recognized an additional impairment loss of $105,000 related to the ARO costs of one of the Gamma Knife units that was removed in January 2022. 

Revenue from Gamma Knife services for the Company during each of the last two years ended December 31, and the percentage of total revenue of the Company represented by the Gamma Knife for each of the last two years, are set forth below:

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The Company conducts its Gamma Knife business through its 81% indirect interest in GKF.

The remaining 19% interest is indirectly owned by Elekta.

The remaining 19% interest is indirectly owned by Elekta through its wholly-owned subsidiary, GKF Investments.

GKF, formed in October 1995, is managed by its policy committee.

The policy committee is composed of one representative from the Company, Craig Tagawa, ASHS’s President, Chief Operating and Financial Officer, and one representative from Elekta.

The policy committee is composed of one representative from the Company, Craig Tagawa, ASHS’s President and Chief Financial Officer, and one representative from Elekta.

The policy committee sets the operating policy for GKF.

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The policy committee selects a manager to handle GKF’s daily operations.

Tagawa, Chief Executive Officer of GKF and President, Chief Operating and Financial Officer of ASHS, serves as GKF’s manager.

Tagawa, Chief Executive Officer of GKF and President and Chief Financial Officer of ASHS, serves as GKF’s manager.

GKF’s profits and/or losses and any cash distributions are allocated based on membership interests.

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The Company believes that these more advanced technologies, with a higher capital cost component, may be potentially a more receptive market segment for its business model.

The Company’s radiation therapy business consisted of one Image Guided Radiation Therapy (“IGRT”) system that began operation in September 2007 at an existing Gamma Knife customer site.

This contract terminated in July 2020 and did not generate any revenue in 2020 or 2021.

Additional information on our operations can be found in Item 7 –

“Management’s Discussion and Analysis of Financial Condition and Results of Operations”

and Note 1 - Business And Basis of Presentation of the consolidated financial statements.

Additional information on our operations can be found in “Item 7 –

Management’s Discussion and Analysis of Financial Condition and Results of Operations”

and “Note 1 - Business And Basis of Presentation”

of the consolidated financial statements.

Proton Beam Radiation Therapy Operations ( “

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PBRT currently treats prostate, brain, spine, head and neck, lung, breast, gastrointestinal tract and pediatric tumors.

More than 200,000 p atients have been treated with protons worldwide.

Prior to December 31, 2020 the Company had $2,250,000 in deposits toward the purchase of two MEVION S250i PBRT systems from Mevion.

The Company reviews the carrying value of its deposits for impairment on a quarterly basis, or as events or circumstances might indicate that the carrying value may not be recoverable.

The Company reviewed the deposits, in light of available information, as of December 31, 2020 and based on its current customer prospects, the impact that the COVID-19 pandemic has had on medical centers undertaking large capital expenditure projects for a limited patient base, and the length of time required to negotiate and implement a proton therapy project, the Company determined that its deposits of $2,250,000, related capitalized interest of and other charges of $1,613,000 were other-than temporarily impaired.

Total impairment related to the proton therapy business was $3,863,000 as of December 31, 2020. 

There was no PBRT impairment recognized as of December 31, 2021.

Approximately  

280,000 p atients have been treated with protons worldwide.

Introduction of PBRT in the United States, until recently, has been limited due to the high capital costs of these projects.

1 unchanged sentence

However, the introduction of the Radiation Oncology Alternative Payment Model (“RO APM”) and the inclusion of PBRT in this model may potentially limit the adoption of PBRT by medical centers.

Additional information on our operations can be found in Item 7 –

“Management’s Discussion and Analysis of Financial Condition and Results of Operations”

and Note 1 - Business And Basis of Presentation of the consolidated financial statements.

Additional information on our operations can be found in “Item 7 –

Management’s Discussion and Analysis of Financial Condition and Results of Operations”

and “Note 1 - Business And Basis of Presentation” of the consolidated financial statements.

The Company’s current business is the outsourcing of stereotactic radiosurgery services and radiation therapy services.

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the total cost of a Gamma Knife facility usually ranges from $3.0 million to $4.5 million, including equipment, site construction and installation;

the total cost of a single room PBRT system usually ranges from $30.0M to $50.0M, inclusive of equipment, site construction and installation.

the total cost of a single room PBRT system usually ranges from $30.0 million to $50.0 million, inclusive of equipment, site construction and installation.

The Company pays for the equipment and the medical center generally pays for site and installation costs.

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The fixed fee per use reimbursement amount that the Company receives from the customer is based on the Company’s cost to provide the service and the anticipated volume of the customer.

The Gamma Knife contracts signed by the Company typically call for a fee ranging from $5,000 t o $9,000 p er procedure.

The Gamma Knife contracts signed by the Company typically call for a fee ranging from $4,500 to $9,000 p er procedure.

There are no minimum volume guarantees required of the customer.

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One customer accounted for approximately 45% and 34% of the Company’s total revenue in 2022 and 2021, respectively.

At December 31, 2022, four customers each individually accounted for 12%, 14%, 16% and 22% of total accounts receivable, respectively.

At December 31, 2021, two customers each individually accounted for 10% and 31% of total accounts receivable, respectively.

At December 31, 2020, four customers each individually accounted for 11%, 11%, 11% and 20% of total accounts receivable, respectively.

The Company markets its Gamma Knife services through its preferred provider status with Elekta and a direct sales effort led by its Senior Vice President, its President, Chief Operating and Financial Officer, and its Chief Executive Officer.

The Company markets its PBRT service through a direct sales effort led by its Senior Vice President, its President, Chief Operating and Financial Officer, and its Chief Executive Officer.

The major advantages to a health care provider in contracting with the Company for its services include:

▪The medical center avoids the high cost of owning the equipment.

By not acquiring the equipment supplied by the Company, the medical center is able to allocate the funds otherwise required to purchase and/or finance the equipment to other projects.

▪The Company does not have minimum volume requirements, so the medical center avoids the risk of equipment under-utilization.

The medical center pays the Company only for each procedure performed on a patient.

The Company markets financial and turnkey solutions to cancer treatment centers, hospitals, and large cancer networks worldwide. 

The Company works closely with major global Original Equipment Manufacturers (“OEM’s”) that provide leading edge clinical treatment systems and software that treat cancer using radiation therapy and radiosurgery.

The major products the Company is able to provide creative financial and turnkey services for are;

MR Guided Radiation Therapy Linacs, Advanced Linear Accelerators, Proton Beam Therapy systems, Brachytherapy systems, and through our GK Financing partnership with Elekta, the Leksell Gamma Knife product and services.

The Company is product agnostic and works with all major OEMs to provide financial solutions to the end users for the products and services they desire. 

 The Company has enhanced and expanded its sales and marketing team and efforts to better provide sales and customer service to the healthcare community.

The Company’s CEO manages directly the day to day operations as well as all sales, marketing, and customer service teams to ensure close contact with the Company’s customer installed base and management of the sales pipeline.

The major advantages to a health care provider in contracting with the Company for its financial and turnkey services include:

▪The cancer care center/medical center avoids the high cost of owning the equipment.

By not acquiring the equipment supplied by the Company, the cancer care/medical center is able to allocate the funds otherwise required to purchase and/or finance the equipment to other projects within their facility.

▪The Company does not have minimum volume requirements, so the cancer care/medical center avoids the risk of equipment under-utilization.

The cancer care/medical center pays the Company only for each procedure performed on a patient.

▪For contracts under revenue sharing arrangements, the Company assumes all or a portion of the risk of reimbursement rate changes.

The medical center pays the Company only the contracted portion of revenue received from each procedure.

▪The medical center transfers the risk of technological obsolescence to the Company.

The medical center and its physicians are not under any obligation to utilize technologically obsolete equipment.

▪The Company provides planning, installation, operating and marketing assistance and support to its customers.

The cancer care/medical center pays the Company only the contracted portion of revenue received from each procedure.

▪The cancer care/medical center transfers the risk of technological obsolescence to the Company.

The cancer care/medical center and its physicians are not under any obligation to utilize technologically obsolete cancer treatment equipment.

▪The Company provides planning, installation, operating and marketing assistance and support to its customers as well as providing turnkey solutions if room modifications, new vault, or even a new cancer care facility is needed by working with creditable and reputable construction companies.

The Company’s Gamma Knife business is operated through GKF.

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The lease financing previously obtained by Orlando was also refinanced as long-term debt by the Credit Agreement.

The Credit Agreement includes a $7,000,000 revolving line of credit that the Company has not drawn on as of December 31, 2021. The Credit Agreement is 48% amortized over a 58-month  period and is 

The Credit Agreement includes a $7,000,000 revolving line of credit that the Company has not drawn on as of December 31, 2022. The Credit Agreement is 48% amortized over a 58-month  period with a balloon payment upon maturity and is 

secured by a lien on substantially all of the assets of the Company and certain of its domestic subsidiaries. 

The Company’s Gamma Knife unit in Ecuador is financed with DFC.

The Company’s Gamma Knife unit in Ecuador is financed with United States 

Development Finance Corporation (“DFC”) .

See Note 5 - Long Term Debt to the consolidated financial statements for additional information.

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There are currently no competing proton therapy facilities near the Company’s site.

There are several competing manufacturers of PBRT systems, including Mevion, IBA Particle Therapy Inc., Varian Medical Systems, Inc., Hitachi Ltd., ProNova Solutions, LLC, Sumitomo Heavy Industries, ProTom International, Inc.

and Mitsubishi Electric.

There are several competing manufacturers of PBRT systems, including Mevion, IBA Particle Therapy Inc., Hitachi Ltd., ProNova Solutions, LLC, Sumitomo Heavy Industries, Ltd., ProTom International, Inc.

and Mitsubishi Electric Corp.

The Company has purchased one MEVION S250 and has made deposits towards the purchase of two additional MEVION S250i systems.

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Currently in the United States, Gamma Knife and proton therapy services are performed primarily on an out-patient basis.

Gamma Knife patients with Medicare as their primary insurer, treated on either an in-patient or out-patient basis, comprise an estimat ed 35%-45% of the total Gamma Knife patients treated nationwide.

PBRT patients with Medicare as their primary insurer are treated primarily on an out-patient basis and comprise an estimated 45% to 50% of the total radiation therapy patients treated.

On September 18, 2020, CMS issued the final rule that would implement a new mandatory payment model for radiation oncology services:

The RO APM is scheduled to commence January 1, 2023 and will be in effect for a five year period.

The RO APM significantly alters CMS' payment methodology from a fee for service paradigm to a set reimbursement by cancer type methodology for radiation services provided within a 90 day episode of care.

Under the RO APM, hospital based and free-standing radiation therapy providers are mandatorily required to participate in the model based on whether the radiation therapy provider is located within a randomly selected Core Based Statistical Area (“CBSA”).

CMS projects that providers treating approximately 30% of radiation oncology patients have been selected to participate in the RO APM.

The remaining providers not included in the RO APM will continue to receive reimbursement based on a fee-for-service methodology.

The RO APM includes but is not limited to PBRT and Gamma Knife services.

Three of the Company's Gamma Knife centers are included in the RO APM.

It is not anticipated that inclusion in the RO APM will have a significant impact on the Company's Gamma Knife revenues.

Gamma Knife patients with Medicare as their primary insurer, treated on either an in-patient or out-patient basis, comprise an es timated 35%-45% of the total Gamma Knife patients treated nationwide.

PBRT patients with Medicare as their primary insurer are treated primarily on an out-patient basis and comprise an estimated 45% of the total radiation therapy patients treated.

On September 18, 2020, CMS issued the final rule that would have implemented a new mandatory payment model for radiation oncology services:

the Radiation Oncology Alternative Payment Method (“RO APM”).

The RO APM, which was to be in effect for a five year period, has been delayed indefinitely.

If the RO APM had not been delayed, it would have significantly altered CMS’

payment methodology from a fee for service paradigm to a set reimbursement by cancer type methodology for radiation services provided within a 90 day episode of care.

Under the RO APM, hospital based and free-standing radiation therapy providers would have been required to participate in the model based on whether the radiation therapy provider is located within a randomly selected core-based statistical area.

CMS projects that providers treating approximately 30% of radiation oncology patients would have been selected to participate in the RO APM.

The remaining providers not included in the RO APM would have continued to receive reimbursement based on a fee-for-service methodology.

The RO APM would have included but would not have been limited to PBRT and Gamma Knife services.

Three of the Company's Gamma Knife centers were expected to be included in the RO APM.

It was not anticipated that inclusion in the RO APM would have a significant impact on the Company's Gamma Knife revenues.

The Company's PBRT center was not selected for inclusion in the RO APM.

Medicare reimbursement in 2022 for the most commonly used PBRT delivery codes increased by approximately 1.8% and increased by approximately 2.2% for Gamma Knife.

Medicare reimbursement in 2023 for the most commonly used PBRT delivery codes increased by approximately 3.2% and 0.2% and decreased by approximately 3.2% for Gamma Knife.

See additional discussion under “Item 1A Risk Factors.”

The average Medicare reimbursement rate trends from 2020 to 2022 are outlined below:

Average Medicare Reimbursement Rate Trends - Gamma Knife

The average Medicare reimbursement rate trends for PBRT from 2020 to 2022 are outlined below.

On August 29, 2022, CMS published a final rule that delayed the start date of the RO APM to a date to be determined through future rulemaking and amended the definition of “model performance period”

to provide that the start and end dates of the five-year model performance period will be established by CMS through future rulemaking.

At this time, it is not clear if the RO APM will be implemented and, if it is implemented, the timing for implementation and in what form it will be implemented. 

If a start date for the RO APM is proposed, CMS will provide at least six months’

notice in advance of the proposed start date, and the proposed start date will be subject to public comment.

The average Medicare reimbursement delivery rate trends from 2021 to 2023 are outlined below:

Average Medicare Reimbursement Delivery Rate Trends - Gamma Knife

The average Medicare reimbursement delivery rate trends for PBRT from 2021 to 2023 are outlined below.

Patients typically undergo 25-40 delivery sessions.

Average Medicare Reimbursement Rate Trends - PBRT

Average Medicare Reimbursement Delivery Rate Trends - PBRT

Simple without Compensation

3 unchanged sentences

Affordable Care Act and Subsequent Regulation

In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, (“Affordable Care Act”), which has resulted in significant changes to the health care industry.

In March 2010, the Patient Protection and Affordable Care Act, was enacted as amended by the Health Care and Education Reconciliation Act of 2010, (“Affordable Care Act”), which has resulted in significant changes to the health care industry.

The primary goal of the legislation was to extend health care coverage to uninsured legal U.S.

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Because the Company is not a health care provider, we were not directly affected by the law, but we could be indirectly affected principally as follows:

An increase in the number of insured residents could potentially increase the number of patients seeking Gamma Knife or radiation therapy treatment.

The repeal of the Affordable Care Act's individual mandate requirement pursuant to the Tax Cuts and Jobs Act of 2017 could results in a decrease in the number of insured patients seeking Gamma Knife or radiation therapy treatment.

The Company’s retail contracts are subject to reimbursement rate changes for radiosurgery or radiation therapy services by the government or other third-party payors.

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This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, started in April 2013, and, due to subsequent legislative amendments, will stay in effect through 2027 unless additional Congressional action is taken.

The Coronavirus Aid, Relief and Economic Security Act of 2020 subsequently extended Medicare sequestration cuts through fiscal year 2030.

On January 2, 2013, the then-U.S.

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The payment of remuneration to induce the referral of health care business has been a subject of increasing governmental and regulatory focus in recent years.

Section 1128B(b) of the Social Security Act (sometimes referred to as the “federal anti-kickback statute”) provides criminal penalties for individuals or entities that offer, pay, solicit or receive remuneration in order to induce referrals for items or services for which payment may be made under the Medicare and Medicaid programs and certain other government funded programs.

Section 1128B(b) of the Social Security Act (sometimes referred to as the “federal anti-kickback statute”) provides criminal penalties and fines for individuals or entities that offer, pay, solicit or receive remuneration in order to induce referrals for items or services for which payment may be made under the Medicare and Medicaid programs and certain other government funded programs.

The Affordable Care Act amended the anti-kickback statute to eliminate the requirement of actual knowledge, or specific intent to commit a violation, of the anti-kickback statute.

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The Company’s Peruvian and Ecuadorian Gamma Knife centers are free-standing facilities operated by GKPeru and GKCE, respectively.

The treating physicians and clinical staff are these facilities are independent contractors.

The treating physicians and clinical staff at these facilities are independent contractors.

The Company maintains general and professional liability insurance consistent with the operations of these facilities and believes its present coverage is adequate for its business.

At December 31, 2021, the Company employed eight people on a full-time basis and 1 person on a temporary basis in the United States, five people on a full-time basis in Lima, Peru, a nd six people on a full-time basis in Guayaquil, Ec uador.

HUMAN CAPITAL RESOURCES

At December 31, 2022, the Company had a workforce of ten people on a full-time basis and one person on a temporary basis in the United States, thirteen people on a full-time basis in Lima, Peru, a nd five people on a full-time basis in Guayaquil, Ec uador.

None of these employees are subject to a collective bargaining agreement and there is no union representation within the Company.

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The executive officers were appointed by the Board of Directors and serve at the discretion of the Board of Directors.

Executive Chairman of the Board

Peter Gaccione

Chief Executive Officer

President, Chief Operating and Financial Officer

Senior Vice President

Stachowiak has served as Chief Executive Officer of the Company since October 1, 2020.

Stachowiak served as Interim President and Chief Executive Officer effective as of May 4, 2020 through September 30, 2020.

President and Chief Financial Officer

Stachowiak was appointed the Executive Chairman of the Board of the Company on March 7, 2023. 

Stachowiak previously served as Chief Executive Officer of the Company from October 1, 2020 to March 7, 2023 and as Interim President and Chief Executive Officer effective as of May 4, 2020 through September 30, 2020.

Stachowiak joined the Board in 2009.

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He is a Certified Public Accountant (inactive), Certified Internal Auditor (inactive) and holds a Certification in Production and Inventory Management.

Tagawa assumed the title of President on October 1, 2020 along with his duties as Chief Operating Officer since February 1999 and Chief Financial Officer since May 1996.

Tagawa also served as Chief Financial Officer from January 1992 through October 1995.

Peter Gaccione was appointed the Chief Executive Officer of the Company on March 7, 2023. 

Gaccione previously served 

as C hief Operating Officer of the Company from September 2022 through March 2023.

He joined the Company in September 2022 and has over 40 years of experience in the global Radiation Oncology and Imaging business.

Most recently, Mr.

Gaccione served as President and a Member of the Executive Management Board of Myocardial Solutions Inc., a medical technology company in the cardiology and cardio-oncology field, where he led the product commercialization, sales, marketing development, and clinical teams.

Prior to that, Mr.

Gaccione held various positions within Elekta AB, a provider of precision radiation oncology treatment systems, brachytherapy, neuroscience, and software solutions from 1997 to 2020, that culminated with his position as President and Chief Executive Officer of Elekta Inc.

and Elekta Medical S.A.

(Mexico), as well as Executive Vice President of Elekta North and Latin America Regions and a Member of the Elekta AB Global Executive Management team from June 2017 to February 2020.

Tagawa serves as the President and Chief Financial Officer. Mr.

Tagawa was also the Chief Operating Officer from February 1999 through September 2022.

Tagawa assumed the title of President on October 1, 2020. Mr.

Taga wa has served as Chief Financial Officer from January 1992 through October 1995 and May 1996 to the present.

Previously a Vice President in such capacity, Mr. Tagawa became a Senior Vice President on February 28, 1993.

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from Cornell University.

Bates joined the Company in January 2007 as Vice President of Sales and Business Development, and assumed the title of Senior Vice President of Sales and Business Development, International Operations on October 1, 2020.

In October 2020, he was appointed to and currently serves as a member of AHMC Seton Medical Community Advisory Board.

He was on the Board of Directors of the Company from 2004 through February 2007.

Prior to joining the Company, he had been Managing Director, Institutional Fixed Income Sales of HSBC Securities (USA), Inc.

Bates has also served as Managing Director, Head of Asian Product for HSBC Securities (USA) Inc.

from 1999 to 2003.

From 1993 through 1999, Mr.

Bates held various positions with Merrill Lynch, last serving as Vice President, European Syndicate for Merrill Lynch International.

He received his undergraduate degree from Brown University and a M.B.A.

degree from The Wharton Business School.

Bates is the son of Dr.

Bates, founder and past Chairman of the Board of the Company.

AVAILABLE INFORMATION

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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