Start Time: 16:30 January 1, 0000 5:00 PM ET Isoray, Inc. (ISR) Q3 2022 Earnings Conference Call May 10, 2022, 16:30 PM ET Company Participants Lori Woods - CEO Jonathan Hunt - CFO Mark Levin - IR Conference Call Participants Frank Takkinen - Lake Street Capital Markets Mike Ott - Oppenheimer Tim Chiang - Northland Operator Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Isoray's Fiscal 3Q 2022 Earnings Call. At this time, all participants will are in a listen-only mode. Afte ...

Isoray, Inc. (ISR) Q2 2022 Earnings Conference Call February 8, 2022 4:30 PM ET Company Participants Mark Levin - IR Lori Woods - CEO Jonathan Hunt - CFO Conference Call Participants Frank Takkinen - Lake Street Capital Markets Mike Ott - Oppenheimer Tim Chiang - Northland Capital Kyle Krueger - Apollo capital Operator Good afternoon, ladies and gentlemen, and welcome to the IsoRay Fiscal Second Quarter 2022 Earnings Call for the quarter ended December 31,2021. At this time, all participants have been place ...

Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to ____________ ...

Isoray, Inc. (ISR) Q1 2022 Earnings Conference Call November 10, 2021 4:30 PM ET Company Representatives Lori Woods - Chief Executive Officer Jonathan Hunt - Chief Financial Officer Mark Levin - Investor Relations Conference Call Participants Frank Takkinen - Lake Street Capital Markets Mike Ott - Oppenheimer Tim Chiang - Northland Capital Operator Good day ladies and gentlemen, and welcome to your IsoRay Inc. Q1 FY 2022 Call. At this time all participants have been placed on a listen-only mode and the floo ...

PART I - FINANCIAL INFORMATION [Item 1 - Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201%20-%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the company's unaudited consolidated financial statements and accompanying notes for the quarter ended September 30, 2021 [Consolidated Balance Sheets (Unaudited)](index=3&type=section&id=Consolidated%20Balance%20Sheets%20(Unaudited)) Total assets and stockholders' equity slightly decreased, primarily driven by a reduction in cash and cash equivalents Consolidated Balance Sheet Summary | Metric | Sep 30, 2021 (in thousands) | Jun 30, 2021 (in thousands) | Change (vs. Jun 30, 2021) | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $61,690 | $63,828 | -$2,138 | | Total current assets | $64,958 | $67,302 | -$2,344 | | Total assets | $68,710 | $70,416 | -$1,706 | | Total current liabilities | $1,799 | $1,801 | -$2 | | Total liabilities | $2,951 | $3,010 | -$59 | | Total stockholders' equity | $65,759 | $67,406 | -$1,647 | [Consolidated Statements of Operations (Unaudited)](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20(Unaudited)) The company reported an increased net loss compared to the prior year, driven by higher operating expenses despite a rise in net sales Consolidated Statement of Operations | Metric | Q3 2021 (in thousands) | Q3 2020 (in thousands) | Change (YoY) | % Change (YoY) | | :--- | :--- | :--- | :--- | :--- | | Sales, net | $2,564 | $2,384 | $180 | 7.55% | | Cost of sales | $1,535 | $1,138 | $397 | 34.89% | | Gross profit | $1,029 | $1,246 | -$217 | -17.42% | | Research and development | $702 | $312 | $390 | 125.00% | | Sales and marketing | $761 | $581 | $180 | 30.98% | | General and administrative | $1,840 | $1,067 | $773 | 72.45% | | Total operating expenses | $3,303 | $1,960 | $1,343 | 68.52% | | Operating loss | $(2,274) | $(714) | -$1,560 | 218.49% | | Net loss | $(2,243) | $(713) | -$1,530 | 214.59% | | Basic and diluted loss per share | $(0.02) | $(0.01) | -$0.01 | 100.00% | | Weighted average shares (Basic/Diluted) | 141,915 | 68,898 | 73,017 | 105.98% | [Consolidated Statements of Cash Flows (Unaudited)](index=5&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) Net cash used in operations increased significantly due to a larger net loss and higher inventory, resulting in a greater overall decrease in cash - The increase in net cash used by operating activities was largely due to a **higher net loss** and a **significant increase in inventory** (from $(63)K in Q3 2020 to $(796)K in Q3 2021)[12](index=12&type=chunk) Consolidated Statement of Cash Flows | Metric | Q3 2021 (in thousands) | Q3 2020 (in thousands) | Change (YoY) | | :--- | :--- | :--- | :--- | | Net cash used by operating activities | $(2,084) | $(338) | $(1,746) | | Net cash used by investing activities | $(54) | $(113) | $59 | | Net decrease in cash, cash equivalents, and restricted cash | $(2,138) | $(451) | $(1,687) | | Cash, cash equivalents, and restricted cash beginning of quarter | $64,010 | $2,573 | $61,437 | [Consolidated Statements of Changes in Stockholders' Equity (Unaudited)](index=6&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Unaudited)) Stockholders' equity decreased during the quarter due to the net loss, which was partially offset by share-based compensation - Share-based compensation contributed **$596K** to additional paid-in capital, while a net loss of **$2,243K** increased the accumulated deficit[19](index=19&type=chunk) Consolidated Statement of Changes in Stockholders' Equity | Metric | Jun 30, 2021 (in thousands) | Sep 30, 2021 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Common Stock Amount | $142 | $142 | $0 | | Additional Paid-in Capital | $158,589 | $159,185 | $596 | | Accumulated Deficit | $(91,325) | $(93,568) | $(2,243) | | Total Stockholders' Equity | $67,406 | $65,759 | $(1,647) | [Notes to the Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements%20(Unaudited)) These notes detail the accounting policies and provide further context for the unaudited interim consolidated financial statements [1. Basis of Presentation](index=7&type=section&id=1.%20Basis%20of%20Presentation) The unaudited interim financial statements are prepared according to SEC rules and GAAP, with management expecting a 0% effective tax rate for fiscal 2022 - The Company anticipates a **0% effective income tax rate** for fiscal year 2022 due to ongoing operating losses and significant net operating losses from prior fiscal years[24](index=24&type=chunk) [2. New Accounting Standards](index=7&type=section&id=2.%20New%20Accounting%20Standards) No new accounting standards are expected to materially impact the company's consolidated financial statements upon future adoption - Accounting standards updates to become effective in future periods are **not expected to have a material impact** on the consolidated financial statements[25](index=25&type=chunk) [3. Loss per Share](index=8&type=section&id=3.%20Loss%20per%20Share) Potentially dilutive securities were excluded from the loss per share calculation as their inclusion would be antidilutive due to the net loss - Due to the Company's net loss, potentially dilutive securities (preferred stock, warrants, options) were **excluded from diluted EPS calculation** as they would be antidilutive[27](index=27&type=chunk) Potential Dilutive Securities (in thousands) | Security Type | Sep 30, 2021 | Sep 30, 2020 | | :--- | :--- | :--- | | Series B preferred stock | - | 59 | | Common stock warrants | 2,646 | 6,080 | | Common stock options | 7,326 | 5,533 | | Total potential dilutive securities | 9,972 | 11,672 | [4. Inventory](index=9&type=section&id=4.%20Inventory) Total inventory increased, driven by a significant rise in non-current enriched barium due to a new consignment agreement - The Company purchased 6,000 mg of enriched barium carbonate for **$720,000** in September 2021 under a new consignment agreement, significantly increasing non-current inventory[30](index=30&type=chunk) Inventory Breakdown (in thousands) | Inventory Type | Sep 30, 2021 | Jun 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Raw materials (current) | $757 | $645 | $112 | | Work in process | $268 | $286 | $(18) | | Finished goods | $35 | $49 | $(14) | | Total inventory, current | $1,060 | $980 | $80 | | Enriched barium (non-current) | $720 | $- | $720 | | Raw materials (non-current) | $72 | $76 | $(4) | | Total inventory, non-current | $792 | $76 | $716 | [5. Property and Equipment](index=9&type=section&id=5.%20Property%20and%20Equipment) Net property and equipment remained stable, with the new production facility project on hold due to sufficient current capacity - Costs associated with a new production facility (approx. **$207,000**) are included in "Other" property and equipment, but the project is currently on hold[32](index=32&type=chunk) Property and Equipment, Net (in thousands) | Asset Category | Sep 30, 2021 | Jun 30, 2021 | Change | | :--- | :--- | :--- | :--- | | Land | $366 | $366 | $0 | | Equipment | $4,305 | $4,202 | $103 | | Leasehold improvements | $4,143 | $4,143 | $0 | | Other | $445 | $495 | $(50) | | Property and equipment | $9,259 | $9,206 | $53 | | Less accumulated depreciation | $(7,306) | $(7,248) | $(58) | | Property and equipment, net | $1,953 | $1,958 | $(5) | [6. Share-Based Compensation](index=10&type=section&id=6.%20Share-Based%20Compensation) Share-based compensation expense increased significantly due to a higher number and fair value of stock option awards granted - The weighted average fair value of stock options issued increased from **$0.46** in Q3 2020 to **$0.58** in Q3 2021, and the number of options granted surged from 40,000 to 2,951,600[34](index=34&type=chunk) - As of September 30, 2021, total unrecognized compensation expense related to stock-based options was approximately **$1,572,000**, expected to be recognized over approximately 1.31 years[36](index=36&type=chunk) Share-Based Compensation Expense (in thousands) | Expense Category | Q3 2021 | Q3 2020 | Change (YoY) | % Change (YoY) | | :--- | :--- | :--- | :--- | :--- | | Cost of sales | $44 | $2 | $42 | 2100.00% | | Research and development expenses | $130 | $12 | $118 | 983.33% | | Sales and marketing expenses | $49 | $18 | $31 | 172.22% | | General and administrative expenses | $373 | $53 | $320 | 603.77% | | Total share-based compensation | $596 | $85 | $511 | 601.18% | [7. Commitments and Contingencies](index=12&type=section&id=7.%20Commitments%20and%20Contingencies) The company updated its Cesium-131 supply contracts, adding a new supplier for enriched barium carbonate manufacturing - A new supply contract with JSC Isotope for Cesium-131 is in effect from **March 2021 through March 2023**[39](index=39&type=chunk) - An addendum signed in August 2021 added **MedikorPharma-Ural LLC** as a supplier of enriched barium carbonate for Cesium-131 manufacturing[39](index=39&type=chunk) [8. Leases](index=13&type=section&id=8.%20Leases) Operating lease expense slightly increased year-over-year, with a weighted average remaining lease term of 2.6 years - As of September 30, 2021, the weighted average remaining lease term was **2.6 years** and the discount rate was **6%**[41](index=41&type=chunk) Operating Lease Expense (in thousands) | Expense Category | Q3 2021 | Q3 2020 | Change (YoY) | | :--- | :--- | :--- | :--- | | Total operating lease expense | $77 | $73 | $4 | | Recognized in cost of sales | $49 | $46 | $3 | | Recognized in G&A expense | $28 | $27 | $1 | [9. Contracts with Customers](index=14&type=section&id=9.%20Contracts%20with%20Customers) Revenue is primarily from domestic sales, with prostate brachytherapy comprising the largest segment at 77% in Q3 2021 - For Q3 2021, **prostate brachytherapy accounted for 77% of revenue**, while other treatments and services comprised 23%[45](index=45&type=chunk) - International revenue was **nominal** for the three months ended September 30, 2021[45](index=45&type=chunk) Revenue Concentration | Customer/Facility | Q3 2021 (% of revenue) | Q3 2020 (% of revenue) | | :--- | :--- | :--- | | El Camino, Los Gatos, & other facilities | 28.5% | 25.7% | | GT Medical Technologies | 15.0% | <10.0% | [Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202%20-%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of the company's financial condition, operational results, and future outlook [Caution Regarding Forward-Looking Information](index=15&type=section&id=Caution%20Regarding%20Forward-Looking%20Information) This report contains forward-looking statements subject to risks and uncertainties that may cause actual results to differ materially - All statements in the Form 10-Q, other than historical facts, that address future activities, events, or developments are **forward-looking statements**[49](index=49&type=chunk) - Forward-looking statements are subject to risks and uncertainties described in Item 1A - Risk Factors, which may cause **actual results to differ materially**[49](index=49&type=chunk) [Critical Accounting Policies and Estimates](index=15&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting policies and estimates, which require management judgment, have not materially changed - The preparation of financial statements requires management to make **estimates and judgments**, which are evaluated on an ongoing basis[51](index=51&type=chunk) - As of September 30, 2021, there have been **no material changes** to the critical accounting policies and estimates discussed in the Company's annual report[51](index=51&type=chunk) [Overview](index=15&type=section&id=Overview) Isoray manufactures and sells Cesium-131 brachytherapy seeds, has secured its supply chain, and is pursuing new R&D initiatives - Isoray manufactures and sells **Cesium-131 brachytherapy seeds (Cesium Blu)** for cancer treatment, utilizing its unique short half-life and energy[52](index=52&type=chunk)[53](index=53&type=chunk) - The Company entered a new supply contract for Cesium-131 and a consignment agreement for enriched barium carbonate to **ensure supply**[55](index=55&type=chunk)[56](index=56&type=chunk)[58](index=58&type=chunk) - R&D initiatives include studying Cesium-131 in combination with immunotherapy and developing a **directional dosing device** for advanced abdominal cancers[59](index=59&type=chunk)[60](index=60&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Net sales increased 8% year-over-year, but gross profit declined 17% due to higher costs, leading to a substantial rise in operating loss [Sales](index=17&type=section&id=Sales) Net sales grew 8% year-over-year, driven by new accounts, though growth was tempered by COVID-19 related disruptions - Sales were negatively impacted by hospitals' renewed focus on COVID-19, **delayed/cancelled procedures**, extended physician vacations, and nursing staff shortages[63](index=63&type=chunk) Sales Performance (in thousands) | Metric | Q3 2021 | Q3 2020 | % Change (YoY) | | :--- | :--- | :--- | :--- | | Sales, net | $2,564 | $2,384 | 8% | | Cost of sales | $1,535 | $1,138 | 35% | | Gross profit | $1,029 | $1,246 | (17)% | Sales by Application (in thousands) | Application | Q3 2021 Amount | Q3 2021 % of Sales | Q3 2020 Amount | Q3 2020 % of Sales | % Change (YoY) | | :--- | :--- | :--- | :--- | :--- | :--- | | Prostate brachytherapy | $1,973 | 77% | $1,890 | 79% | 4% | | Other sales | $591 | 23% | $494 | 21% | 20% | | Total Sales, net | $2,564 | 100% | $2,384 | 100% | 8% | [Prostate Brachytherapy](index=19&type=section&id=Prostate%20Brachytherapy) Prostate sales grew 4% year-over-year, with future growth anticipated from a projected increase in new cancer diagnoses - Prostate sales **increased by 4% YoY**, but growth was limited by hospital focus on COVID-19 and related procedure delays[68](index=68&type=chunk) - The American Cancer Society estimates a nearly **30% increase in new prostate cancer cases** in 2021, which management believes will drive continued growth[69](index=69&type=chunk) - The Company began treating patients with **C4 Imaging's Sirius® positive-signal MRI markers** with Cesium-131 seeds in October[70](index=70&type=chunk) [Other Sales](index=19&type=section&id=Other%20Sales) Other sales grew 20% year-over-year, with new billing codes expected to boost future usage and reimbursement - Other sales **increased by 20% YoY**, mainly due to increased services and treatments for pelvic and lung cancers[71](index=71&type=chunk) - CMS approved **64 new ICD-10-PCS billing codes** for Cesium-131, which are expected to provide greater impetus for usage and reimbursement[74](index=74&type=chunk)[75](index=75&type=chunk) [GammaTile™](index=19&type=section&id=GammaTile%E2%84%A2) Isoray is a contract manufacturer for GammaTile™ Therapy, with revenues from this partnership comprising 15% of total sales - Isoray is a **contract manufacturer for GammaTile™ Therapy**, which delivers Cesium-131 brachytherapy seeds for brain cancer treatment[76](index=76&type=chunk) - GammaTile™ Therapy received **expanded FDA clearance** in January 2020 to include treatment of newly diagnosed malignant brain tumors[77](index=77&type=chunk)[78](index=78&type=chunk) - Total revenues from sales to GT Med Tech were approximately **15% of total sales** for the three months ended September 30, 2021[78](index=78&type=chunk) [Cost of sales](index=20&type=section&id=Cost%20of%20sales) Cost of sales increased 35% year-over-year, driven by higher isotope, materials, labor, and depreciation expenses - Cost of sales **increased by 35% YoY**, driven by higher isotope and other materials costs, increased labor, and higher depreciation[80](index=80&type=chunk) - Lower than forecasted sales volumes resulted in **excess unused isotope**, contributing to increased cost of sales[80](index=80&type=chunk) [Gross Profit](index=20&type=section&id=Gross%20Profit) Gross profit declined 17% year-over-year due to lower-than-anticipated sales volumes and increased isotope and payroll costs - Gross profit **declined by 17% YoY**, attributed to lower sales volumes, increased isotope costs due to excess unused inventory, and higher payroll and material costs[81](index=81&type=chunk) [Research and development](index=20&type=section&id=Research%20and%20development) R&D expenses increased 125% year-over-year, driven by higher payroll and consulting expenses for market research - R&D expenses **increased by 125% YoY**, driven by higher payroll and increased market research consulting, partially offset by reduced investment in the Blu Build™ delivery system[83](index=83&type=chunk) - The Company received **FDA 510k clearance** for C4 Imaging's Sirius® positive-signal MRI markers with Cesium-131 seeds in December 2020[85](index=85&type=chunk) [Sales and marketing expenses](index=21&type=section&id=Sales%20and%20marketing%20expenses) Sales and marketing expenses rose 31% year-over-year due to increased travel, tradeshow, and payroll costs as COVID-19 restrictions eased - Sales and marketing expenses **increased by 31% YoY**, mainly due to higher travel and tradeshow costs and increased payroll[88](index=88&type=chunk) [General and administrative expenses](index=21&type=section&id=General%20and%20administrative%20expenses) G&A expenses increased 72% year-over-year, driven by higher payroll, insurance, professional fees, and a shift in stock grant timing - G&A expenses **increased by 72% YoY**, attributed to higher payroll, hiring expenses, IT consulting, D&O insurance, public company expenses, audit/legal fees, and travel[90](index=90&type=chunk) - The timing of annual employee and director stock grants in July 2021 **increased share-based compensation expense** in Q3 2021[90](index=90&type=chunk) [Impact of COVID-19](index=21&type=section&id=Impact%20of%20COVID-19) Sales revenue remained below pre-pandemic levels as hospitals' focus on COVID-19 variants led to delayed or cancelled procedures - Despite an 8% sales increase in Q3 2021 YoY, revenues remained **below pre-COVID-19 levels** due to the Delta variant's impact on procedures[92](index=92&type=chunk) - The Company **missed its target of 25% increased revenue** in Q3 2022 due to the Delta variant and increased physician vacations[93](index=93&type=chunk) [Liquidity and capital resources](index=21&type=section&id=Liquidity%20and%20capital%20resources) The company projects sufficient cash for the next twelve months but forecasts increased cash needs for strategic investments [Cash flows from operating activities](index=23&type=section&id=Cash%20flows%20from%20operating%20activities) Net cash used by operating activities increased significantly, driven by a larger net loss and increased inventory purchases - Net cash used by operating activities was **$2.084 million** in Q3 2021, primarily driven by a **$2.24 million net loss** and increased inventory[97](index=97&type=chunk) - The increase in inventory was mainly due to the **purchase of enriched barium carbonate**[97](index=97&type=chunk) [Cash flows from investing activities](index=23&type=section&id=Cash%20flows%20from%20investing%20activities) Investing activities primarily involved the purchase of fixed assets, with plans to continue investing in production technology Cash Used in Investing Activities (in thousands) | Metric | Q3 2021 | Q3 2020 | Change (YoY) | | :--- | :--- | :--- | :--- | | Additions to property and equipment | $(54) | $(113) | $59 | | Net cash used by investing activities | $(54) | $(113) | $59 | [Cash flows from Financing activities](index=23&type=section&id=Cash%20flows%20from%20Financing%20activities) There were no financing activities during the quarters ended September 30, 2021, and 2020 - **No financing activities** occurred in Q3 2021 or Q3 2020[100](index=100&type=chunk) [Projected fiscal 2022 liquidity and capital resources](index=23&type=section&id=Projected%20fiscal%202022%20liquidity%20and%20capital%20resources) Management forecasts increased cash needs for fiscal 2022 but expects current cash to be sufficient for the next twelve months - Fiscal 2022 cash requirements are projected to increase due to planned investments in **sales & marketing, R&D, and G&A**[101](index=101&type=chunk) - Current cash and cash equivalents are expected to be **sufficient for projected operating cash needs** for the next twelve months[101](index=101&type=chunk) - The Company anticipates reaching **cashflow break-even in three to four years**, assuming a 25% annual revenue growth[101](index=101&type=chunk) [Capital expenditures](index=23&type=section&id=Capital%20expenditures) Construction of a new facility is on hold as current production capacity is sufficient, with a focus on deploying capital to support sales growth - The design for a new production and administration facility is complete, but **construction is on hold** due to sufficient current production capacity[102](index=102&type=chunk) - Management is reviewing all operations to **efficiently deploy capital** for materials, systems, and personnel to drive sales[103](index=103&type=chunk) [Financing activities](index=24&type=section&id=Financing%20activities) Future capital needs are expected to be financed through equity sales, collaborations, or debt, which may be dilutive to stockholders - Future capital needs are expected to be financed through equity sales, strategic collaborations, or debt financing, which may be **dilutive to existing stockholders**[105](index=105&type=chunk) [Other commitments and contingencies](index=24&type=section&id=Other%20commitments%20and%20contingencies) There have been no material changes to other commitments and contingencies outside the ordinary course of business - **No material changes** to other commitments and contingencies occurred in Q3 2021, other than those disclosed in Note 7[106](index=106&type=chunk) [Off-balance sheet arrangements](index=24&type=section&id=Off-balance%20sheet%20arrangements) The Company has no off-balance sheet arrangements - The Company has **no off-balance sheet arrangements**[107](index=107&type=chunk) [Critical accounting policies and estimates](index=24&type=section&id=Critical%20accounting%20policies%20and%20estimates) The discussion reiterates that financial statements rely on management's estimates and no changes occurred in Q3 2021 - The preparation of consolidated financial statements requires management to make **estimates and judgments**, which are evaluated on an ongoing basis[108](index=108&type=chunk) - There have been **no changes to critical accounting policies** and estimates during the three months ended September 30, 2021[109](index=109&type=chunk) [Item 3 - Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203%20-%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there are no quantitative and qualitative disclosures about market risk applicable to the Company - This item is **not applicable** to the Company[110](index=110&type=chunk) [Item 4 - Controls and Procedures](index=24&type=section&id=Item%204%20-%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2021 - Management concluded that the Company's disclosure controls and procedures were **effective** as of September 30, 2021[111](index=111&type=chunk) - **No material changes** in internal control over financial reporting occurred during the most recent fiscal quarter[112](index=112&type=chunk) PART II - OTHER INFORMATION [Item 1 - Legal Proceedings](index=25&type=section&id=Item%201%20-%20Legal%20Proceedings) The Company has nothing to disclose regarding legal proceedings - There are **no legal proceedings** to disclose[114](index=114&type=chunk) [Item 1A - Risk Factors](index=25&type=section&id=Item%201A%20-%20Risk%20Factors) A new material risk highlights heavy reliance on three customers, while uncertainty regarding Medicare reimbursement has been favorably resolved - Approximately **50% of the Company's revenues are dependent on three customers**, with one group accounting for 29%, posing a material risk if any are lost[115](index=115&type=chunk) - CMS finalized a rule to keep all brachytherapy on a **fee-for-service model**, removing it from the bundled RO APM, which management believes is favorable[119](index=119&type=chunk)[120](index=120&type=chunk) [Item 2 - Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202%20-%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to disclose - **None to disclose**[123](index=123&type=chunk) [Item 3 - Defaults Upon Senior Securities](index=26&type=section&id=Item%203%20-%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to disclose - **None to disclose**[123](index=123&type=chunk) [Item 4 - Mine Safety Disclosures](index=26&type=section&id=Item%204%20-%20Mine%20Safety%20Disclosures) This item is not applicable to the Company - **Not applicable**[124](index=124&type=chunk) [Item 5 - Other Information](index=26&type=section&id=Item%205%20-%20Other%20Information) There is no other information to disclose - **None to disclose**[125](index=125&type=chunk) [Item 6. Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including supply contracts, agreements, and officer certifications - Key exhibits include addendums to the Cesium-131 supply contract and a **new consignment agreement** with MedikorPharma-Ural LLC[127](index=127&type=chunk) - The filing includes **Rule 13a-14(a)/15d-14(a) certifications** from the Principal Executive Officer and Co-Principal Financial Officers, as well as Section 1350 Certifications[127](index=127&type=chunk) [Signatures](index=28&type=section&id=Signatures) The report is signed by the Chief Executive Officer, Chief Financial Officer, and Vice President of Finance and Corporate Controller - The report was signed by Lori A. Woods (CEO), Jonathan Hunt (CFO), and Mark J. Austin (VP of Finance and Corporate Controller) on **November 10, 2021**[128](index=128&type=chunk)[129](index=129&type=chunk)

PART I [Business](index=4&type=section&id=ITEM%201%20%E2%80%93%20BUSINESS) The company develops and sells Cesium-131 brachytherapy seeds, primarily for prostate cancer, while expanding into other treatments like brain cancer - Isoray's core business is the development, manufacture, and sale of Cesium-131 brachytherapy seeds for treating malignant tumors; prostate cancer treatment represents approximately **75%** of the company's business[16](index=16&type=chunk)[21](index=21&type=chunk)[26](index=26&type=chunk) - The company collaborates with GT Medical Technologies, Inc ("GT Med Tech") to supply Cesium-131 seeds for GammaTile™ Therapy, a treatment for brain cancer that received FDA clearance in July 2018 and launched a full market release in January 2020[40](index=40&type=chunk)[48](index=48&type=chunk)[95](index=95&type=chunk) - Isoray's strategy for fiscal year 2022 includes investing in sales and marketing for its core prostate business, commercializing the Blu Build™ loader for intra-operative customization, supporting GT Med Tech's GammaTile™ launch, and expanding the use of Cesium-131 for other cancers[113](index=113&type=chunk)[116](index=116&type=chunk)[119](index=119&type=chunk) - The company is **solely reliant on a Russian supplier**, JSC Isotope, for its Cesium-131 isotope, with a supply contract extending through March 31, 2023; the company has no domestic suppliers[148](index=148&type=chunk)[153](index=153&type=chunk)[155](index=155&type=chunk) Top Customers as a Percentage of Total Sales (FY 2021) | Facility/Customer | Location | % of Revenue | | :--- | :--- | :--- | | El Camino, Los Gatos, and other facilities | Northern CA | 25.3% | | GT Medical Technologies | Arizona | 11.3% | | **Total Top Two** | | **36.6%** | [Risk Factors](index=38&type=section&id=ITEM%201A%20%E2%80%93%20RISK%20FACTORS) The company faces significant risks from its single-product focus, sole Russian supplier dependency, customer concentration, and regulatory uncertainties - The COVID-19 pandemic and its variants pose a material risk to the company's financial condition, potentially impacting its Russian supply chain, product sales due to postponed surgeries, and ability to obtain licensure at new locations[234](index=234&type=chunk)[236](index=236&type=chunk) - The company's revenue depends entirely on its single product, the Cesium-131 brachytherapy seed, making it vulnerable to shifts in market acceptance, pricing pressures, and regulatory changes[239](index=239&type=chunk) - Isoray is **heavily reliant on a single Russian supplier** (JSC Isotope) and its two nuclear reactors for Cesium-131, with no domestic supply capabilities; this concentration poses significant risks of supply interruption due to potential shutdowns, political instability, or sanctions[240](index=240&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk) - Approximately **42% of the company's revenue is dependent on three customers**, with one customer accounting for 25%; the loss of any of these customers would have a material adverse effect on revenues[264](index=264&type=chunk) - The company faces uncertainty regarding reimbursement from third-party payers like Medicare; proposed changes such as the Radiation Oncology Alternative Payment Model (RO APM) could impact payment structures, although a recent proposal suggests excluding brachytherapy, which would be favorable[250](index=250&type=chunk)[251](index=251&type=chunk)[253](index=253&type=chunk) [Unresolved Staff Comments](index=59&type=section&id=ITEM%201B%20%E2%80%93%20UNRESOLVED%20STAFF%20COMMENTS) The company reports no unresolved comments from SEC staff - Not applicable[334](index=334&type=chunk) [Properties](index=59&type=section&id=ITEM%202%20%E2%80%93%20PROPERTIES) The company leases its main facility in Richland, WA, and has paused plans for constructing a new facility on an adjacent owned property - The company leases its executive office and production facility space of approximately 15,300 square feet in Richland, WA; the lease was modified in July 2019 to extend the term to April 30, 2026[335](index=335&type=chunk) - Isoray purchased a 4.2-acre property in 2017 for a future production, lab, and administrative facility; while the design is complete, construction is on hold as the company focuses resources on revenue growth[336](index=336&type=chunk) [Legal Proceedings](index=59&type=section&id=ITEM%203%20%E2%80%93%20LEGAL%20PROCEEDINGS) The company reports no material pending legal proceedings - Nothing to disclose[338](index=338&type=chunk) [Mine Safety Disclosures](index=60&type=section&id=ITEM%204%20%E2%80%93%20MINE%20SAFETY%20DISCLOSURES) This section is not applicable to the company's operations - Not applicable[340](index=340&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=60&type=section&id=ITEM%205%20%E2%80%93%20MARKET%20FOR%20REGISTRANT'S%20COMMON%20EQUITY,%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common stock trades on the NYSE American; no cash dividends have been paid, and equity plans authorize future share issuance - The company's common stock trades on the NYSE American under the symbol "ISR"; as of September 23, 2021, there were **141,915,266 shares outstanding**[341](index=341&type=chunk) - The company has **never paid cash dividends** and does not plan to in the foreseeable future, anticipating that any earnings will be retained to finance operations[343](index=343&type=chunk) - The 2020 Equity Incentive Plan allows for the grant of up to 6,000,000 shares, and the 2017 plan allows for up to 4,000,000 shares; as of June 30, 2021, **4,593,125 securities remained available for future issuance** under equity compensation plans approved by security holders[346](index=346&type=chunk)[347](index=347&type=chunk)[351](index=351&type=chunk) Quarterly Stock Price (Fiscal 2021) | Quarter | High ($) | Low ($) | | :--- | :--- | :--- | | Q1 | 0.78 | 0.54 | | Q2 | 0.58 | 0.36 | | Q3 | 2.47 | 0.53 | | Q4 | 1.15 | 0.75 | [Selected Financial Data](index=62&type=section&id=ITEM%206%20%E2%80%93%20SELECTED%20FINANCIAL%20DATA) Disclosure is not required as the company qualifies as a smaller reporting company - Disclosure is not required as the company is a smaller reporting company[355](index=355&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=63&type=section&id=ITEM%207%20%E2%80%93%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Fiscal 2021 sales grew 4% driven by non-prostate treatments, while gross margin slightly declined and liquidity significantly improved via equity offerings - The company's cash position increased significantly, ending FY 2021 with **$63.8 million in cash and cash equivalents**, up from $2.4 million in FY 2020; this was primarily due to raising **$56.4 million from two underwritten offerings** and $7.8 million from warrant exercises[392](index=392&type=chunk)[401](index=401&type=chunk)[513](index=513&type=chunk) - Management projects that current cash and cash equivalents are sufficient to meet operating needs for the next twelve months; the company anticipates reaching cash flow break-even in three to four years, assuming annual revenue growth of twenty-five percent[402](index=402&type=chunk) Results of Operations (in thousands) | Metric | FY 2021 | FY 2020 | % Change | | :--- | :--- | :--- | :--- | | Sales, net | $10,053 | $9,680 | 4% | | Gross profit | $5,121 | $5,124 | 0% | | Gross Margin | 51% | 53% | -2 p.p. | | Operating loss | ($3,446) | ($3,476) | 1% | | Net loss | ($3,387) | ($3,446) | -2% | Sales by Treatment Type (in thousands) | Treatment | FY 2021 | FY 2020 | % Change | | :--- | :--- | :--- | :--- | | Prostate Brachytherapy | $7,824 | $8,356 | (6%) | | Other sales | $2,229 | $1,324 | 68% | | **Total Sales, net** | **$10,053** | **$9,680** | **4%** | [Quantitative and Qualitative Disclosures About Market Risk](index=73&type=section&id=ITEM%207A%20%E2%80%93%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) Disclosure is not required as the company qualifies as a smaller reporting company - Disclosure is not required as the company is a smaller reporting company[419](index=419&type=chunk) [Financial Statements and Supplementary Data](index=73&type=section&id=ITEM%208%20%E2%80%93%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) This section presents the company's audited consolidated financial statements and the independent auditor's unqualified opinion for the past three fiscal years Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2021 | June 30, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $63,828 | $2,392 | | Total current assets | $67,302 | $5,507 | | Total assets | $70,416 | $8,699 | | **Liabilities & Equity** | | | | Total current liabilities | $1,801 | $1,575 | | Total liabilities | $3,010 | $2,976 | | Total stockholders' equity | $67,406 | $5,723 | Consolidated Statement of Operations Highlights (in thousands) | Metric | FY 2021 | FY 2020 | FY 2019 | | :--- | :--- | :--- | :--- | | Sales, net | $10,053 | $9,680 | $7,314 | | Gross profit | $5,121 | $5,124 | $3,047 | | Operating loss | ($3,446) | ($3,476) | ($5,254) | | Net loss | ($3,387) | ($3,446) | ($5,144) | | Net loss per share | ($0.03) | ($0.05) | ($0.08) | Consolidated Statement of Cash Flows Highlights (in thousands) | Metric | FY 2021 | FY 2020 | FY 2019 | | :--- | :--- | :--- | :--- | | Net cash used by operating activities | ($2,837) | ($3,641) | ($5,049) | | Net cash provided by (used in) investing activities | ($410) | ($287) | $401 | | Net cash provided by financing activities | $64,684 | $994 | $7,374 | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=73&type=section&id=ITEM%209%20%E2%80%93%20CHANGES%20IN%20AND%20DISAGREEMENTS%20WITH%20ACCOUNTANTS%20ON%20ACCOUNTING%20AND%20FINANCIAL%20DISCLOSURE) The company reports no disagreements with its independent registered public accounting firm - There were no disagreements with the company's accountants[423](index=423&type=chunk) [Controls and Procedures](index=73&type=section&id=ITEM%209A%20%E2%80%93%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls, procedures, and internal control over financial reporting were effective as of June 30, 2021 - Management, including the CEO and co-principal financial officers, concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2021[420](index=420&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of June 30, 2021, based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in its 2013 framework[421](index=421&type=chunk)[422](index=422&type=chunk) - There were **no changes in internal control** over financial reporting during the fourth fiscal quarter that materially affected, or are reasonably likely to materially affect, these controls[425](index=425&type=chunk) [Other Information](index=74&type=section&id=ITEM%209B%20%E2%80%93%20OTHER%20INFORMATION) This section is not applicable - Not applicable[426](index=426&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=74&type=section&id=ITEM%2010%20%E2%80%93%20DIRECTORS,%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) This section details the composition of the board and executive team, committee structures, and discloses late Form 4 filings by insiders - The Board of Directors as of June 30, 2021, consisted of Michael McCormick (Chairman), Lori Woods (CEO), Philip Vitale, MD, and Alan Hoffmann[427](index=427&type=chunk)[429](index=429&type=chunk) - The company's executive officers include Lori Woods (CEO), Jonathan Hunt (CFO), Mark Austin (VP of Finance and Corporate Controller), William Cavanagh III (Chief R&D Officer), and Jennifer Streeter (COO)[436](index=436&type=chunk) - Several executive officers and directors **filed late Form 4s** during the fiscal year ended June 30, 2021, including Lori Woods, Michael McCormick, Alan Hoffmann, and Philip Vitale[444](index=444&type=chunk) - The Board has determined that Alan Hoffmann qualifies as an **"audit committee financial expert,"** and that he, along with Michael McCormick and Dr Philip Vitale, are independent directors[451](index=451&type=chunk)[491](index=491&type=chunk) [Executive Compensation](index=78&type=section&id=ITEM%2011%20%E2%80%93%20EXECUTIVE%20COMPENSATION) Executive compensation is performance-based, with significant base salary increases approved in May 2021 to align with market rates - In May 2021, the Compensation Committee **significantly increased annual base salaries** for key executives: Lori Woods to $439,810 (26.7% increase), William Cavanagh to $300,000 (25.0% increase), and Jennifer Streeter to $337,840 (34.7% increase)[464](index=464&type=chunk) - The fiscal 2021 bonus plan was based on quarterly and annual performance metrics for revenue growth, gross margin, and net loss margin; the company **achieved 12.5% of the target metrics**, resulting in bonuses being paid out[472](index=472&type=chunk)[473](index=473&type=chunk) - Independent directors received $3,000 per month plus meeting fees in fiscal 2021; beginning in fiscal 2022, this was changed to a flat $5,000 per month with no per-meeting fees[469](index=469&type=chunk) Summary Compensation Table (FY 2021 vs. FY 2020) | Name and Position | Year | Salary ($) | Option Awards ($) | Non-Equity Incentive ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Lori Woods** (CEO) | 2021 | 353,450 | - | 17,745 | 371,195 | | | 2020 | 315,612 | 98,700 | 77,325 | 491,637 | | **William Cavanagh** (CRDO) | 2021 | 244,149 | - | 9,190 | 253,339 | | | 2020 | 220,256 | 59,220 | 38,545 | 318,021 | | **Jennifer Streeter** (COO) | 2021 | 256,672 | - | 9,677 | 266,349 | | | 2020 | 214,565 | 59,220 | 38,500 | 312,285 | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=84&type=section&id=ITEM%2012%20%E2%80%93%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) Directors and executive officers as a group beneficially owned approximately 2.39% of common stock as of September 23, 2021 - As of September 23, 2021, directors and executive officers as a group beneficially owned **2.39%** of the company's 141,915,266 outstanding common shares[481](index=481&type=chunk)[482](index=482&type=chunk) - CEO Lori Woods is the largest beneficial owner among the executive officers and directors, holding **0.76%** of the class[482](index=482&type=chunk) - All outstanding Series B preferred stock (59,065 shares) was automatically converted into common stock as a result of the October 22, 2020 offering; as of June 30, 2021, **no preferred stock was outstanding**[486](index=486&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=85&type=section&id=ITEM%2013%20%E2%80%93%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS,%20AND%20DIRECTOR%20INDEPENDENCE) The company reports no related party transactions and confirms the independence of three board members - There were **no related party transactions** requiring disclosure under Regulation S-K Item 404 during the fiscal year[488](index=488&type=chunk)[490](index=490&type=chunk) - The Board of Directors has determined that three of its members—Mr Hoffmann, Mr McCormick, and Dr Vitale—qualify as **independent directors** under NYSE American standards[491](index=491&type=chunk) [Principal Accountant Fees and Services](index=86&type=section&id=ITEM%2014%20%E2%80%93%20PRINCIPAL%20ACCOUNTANT%20FEES%20AND%20SERVICES) Total fees paid to the principal accountant, Assure CPA, LLC, were $104,000 for fiscal year 2021 - The Audit Committee has a pre-approval policy for all audit and permitted non-audit services provided by the independent registered public accountants; all services provided by Assure CPA, LLC were approved by the Audit Committee[495](index=495&type=chunk) Accountant Fees (in thousands) | Fee Type | FY 2021 ($) | FY 2020 ($) | | :--- | :--- | :--- | | Audit Fees | 67 | 74 | | Tax Fees | 11 | 12 | | All other Fees | 26 | 13 | | **Total** | **104** | **99** | PART IV [Exhibits and Financial Statement Schedules](index=87&type=section&id=ITEM%2015%20%E2%80%93%20EXHIBITS%20AND%20FINANCIAL%20STATEMENT%20SCHEDULES) This section provides an index to the financial statements and a list of all exhibits filed with the Form 10-K - This item contains the index to the Consolidated Financial Statements and the Exhibit Index, which lists all documents filed with the report[499](index=499&type=chunk)[501](index=501&type=chunk) [Form 10-K Summary](index=120&type=section&id=ITEM%2016%20%E2%80%93%20FORM%2010-K%20SUMMARY) The company has opted not to provide a Form 10-K summary - None[650](index=650&type=chunk)

IsoRay, Inc. (ISR) Q4 2021 Earnings Conference Call September 21, 2021 4:30 PM ET Company Participants Mark Levin - IR Lori Woods - CEO Jonathan Hunt - CFO Conference Call Participants Frank Takkinen - Lake Street Tim Chiang - Northland Capital Mike Ott - Oppenheimer Operator Good day, ladies and gentlemen, and welcome to your IsoRay Fourth Quarter and Fiscal Yearend 2021 Financial Results Call. All lines have been placed on a listen-only mode and the floor will be opened for your questions and comments fol ...

Call Start: 16:00 January 1, 0000 4:27 PM ET CrossAmerica Partners LP (CAPL) Q3 2021 Earnings Conference Call May 13, 2021, 16:00 PM ET Company Participants Mark Levin - IR Lori Woods - CEO Jonathan Hunt - CFO Conference Call Participants Frank Takkinen - Lake Street Mike Ott - Oppenheimer Operator Greetings, welcome to the IsoRay Inc.'s Q3 Fiscal Year 2021 Call. At this time, all participants will be in a listen-only mode. And the question-and-answer session will follow the formal presentation. [Operator I ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to ____________ Commission File No. 001-33407 ISORAY, INC. (Exact name of registrant as specified in its charter) Delaware 41-1458152 (State ...

An Emerging Leader in Targeted Internal Radiation Therapy March 2021 Investor Presentation NYSE American: ISR ©2021 Isoray Inc. Safe Harbor Statement Statements in this presentation about Isoray's future expectations, including: the anticipated continued growth in revenues in fiscal year 2021, the impact of COVID-19 on our financial results and the timing of recovery in our brachytherapy procedures, suppliers, scheduling of procedures, and employees, advantages of our products including Blu Build and the Ga ...