Financial Data and Key Metrics Changes - As of September 30, 2022, cash on hand was $85 million, with an additional $40 million available from existing financing facilities subject to milestones [12] - Net cash usage for operating activities in the quarter was $14.3 million, representing a 22% reduction of $3.9 million compared to the same quarter in FY 2022, and a 47% reduction of $12.5 million compared to the same quarter in FY 2021 [13] - Revenue from royalty on sales of TEMCELL in Japan for the quarter was $1.4 million, with a 9% increase in royalties for the 12-month period ended September 30, 2022, totaling $7.7 million [14][15] Business Line Data and Key Metrics Changes - The majority of revenue changes were attributed to a one-off licensing milestone in the prior period and currency movements, with a 23% decrease in R&D, manufacturing, and management administration expenditures totaling $5.2 million [15] - Prelaunch manufacturing activities and product testing for remestemcel continued, with inventory valued at $28 million to be recognized upon FDA approval [16] Market Data and Key Metrics Changes - The market opportunity for rexlemestrocel in chronic low back pain is significant, with approximately 6 million to 7 million patients suffering from inflammatory chronic low back pain in the U.S. and EU5 [27] - Cardiovascular disease remains the leading cause of death in the U.S., affecting 6.5 million to 7 million patients annually, highlighting the unmet need for heart failure treatments [34] Company Strategy and Development Direction - The company is focused on addressing significant unmet medical needs, particularly in pediatric acute graft-versus-host disease with remestemcel-L, which has received fast track designation and BLA priority review from the FDA [4][26] - The strategy includes advancing rexlemestrocel for chronic low back pain and chronic heart failure, with plans for confirmatory Phase III trials and potential partnerships for commercialization [32][56] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of the long-term survival data for remestemcel-L as a cornerstone for BLA resubmission, indicating confidence in the product's potential impact on patient outcomes [39] - The company is building commercial capabilities in anticipation of product approval and launch, aiming for immediate market entry post-approval [44] Other Important Information - The company has generated new data from an observational survival study, showing improved survival outcomes for patients treated with remestemcel compared to best available therapies [7][26] - The company is finalizing trial designs for both chronic low back pain and heart failure, with expectations to start trials in 2023 [56] Q&A Session Summary Question: Can you comment on the commercial launch timeline for remestemcel-L after approval? - Management expects to launch the product immediately after approval, with a review period of 2 to 6 months due to priority review designation [41][44] Question: What is the pathway to approval for the heart failure opportunity? - The company plans to meet with the FDA to discuss the totality of data and has an RMAT designation in place for the LVAD population [45] Question: How does the new survival data relate to the CRL response? - The new survival data has not yet been provided to the FDA and will be filed shortly, meaning the review clock has not started yet [48][50] Question: What are the plans for advancing the lower back pain study into Phase III? - The company expects to begin two trials in the second or third quarter of 2023, with pain reduction as the primary endpoint [56]

[Executive Summary & Operational Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Operational%20Highlights) Mesoblast's CEO highlighted FY2022 as transformational with planned BLA resubmission for remestemcel-L and significant progress in rexlemestrocel-L development, alongside a **35% reduction** in net operating spend and a strong cash position [CEO's Message](index=1&type=section&id=CEO%27s%20Message) Dr. Silviu Itescu, CEO, highlighted FY2022 as a transformational year, focusing on the planned BLA resubmission for remestemcel-L in pediatric SR-aGVHD, validation of its potency assay, and the significant unmet need for this therapy. He also noted the **36% increase** in **TEMCELL® HS Inj.** royalties and the pivotal stage of **rexlemestrocel-L** development for **HFrEF** and **CLBP**, with planned **FDA** meetings and trial commencements - **BLA** resubmission for **remestemcel-L** in children with steroid-refractory acute graft versus host disease (**SR-aGVHD**) is planned for this quarter, with validated key potency assay addressing prior **FDA** concerns[4](index=4&type=chunk) - Royalty income from sales of **TEMCELL® HS Inj.** in Japan increased **36%** on a constant currency basis to almost **US$10 million**, indicating continued physician adoption[4](index=4&type=chunk) - **Rexlemestrocel-L** is at a pivotal stage for chronic heart failure with reduced ejection fraction (**HFrEF**) and chronic low back pain (**CLBP**), with planned **FDA** meetings for marketing approval pathways and pivotal trial commencement[4](index=4&type=chunk) [Key Financial & Operational Highlights](index=1&type=section&id=Key%20Financial%20%26%20Operational%20Highlights) Mesoblast reported a cash position of **US$60.4 million** at June 30, 2022, with a pro-forma **US$105.5 million** after a private placement. The company achieved a **35% reduction** in net operating spend and is progressing with key regulatory milestones for its product candidates, including **BLA** resubmission for **remestemcel-L** and **FDA** clearance for **rexlemestrocel-L** trials Cash-on-hand (June 30, 2022) | Metric | Amount (US$M) | | :--- | :--- | | Cash-on-hand (June 30, 2022) | 60.4 | | Pro-forma cash (after Aug 2022 private placement) | 105.5 | | Additional funds available from existing facilities | Up to 40.0 | - Net operating spend for the 12 months ended June **FY2022** was **US$65.8 million**, representing a **35% reduction** compared to the prior year, reflecting a continued focus on cost control[5](index=5&type=chunk) - **BLA** resubmission for **remestemcel-L** in children with **SR-aGVHD** is expected this quarter, with potential US approval in **Q1 CY2023**[5](index=5&type=chunk) - **FDA** clearance is anticipated by **year-end 2022** to commence a pivotal study for potential marketing approval of **rexlemestrocel-L** in chronic lower back pain due to degenerative disc disease[5](index=5&type=chunk) [Product Pipeline & Near-Term Milestones](index=3&type=section&id=Product%20Pipeline%20%26%20Near-Term%20Milestones) Mesoblast provided updates on its product pipeline, including significant progress towards **BLA** resubmission for **remestemcel-L** in **SR-aGVHD** and positive Phase 3 data for **rexlemestrocel-L** in **HFrEF** and **CLBP**, with planned **FDA** meetings and trial commencements [Remestemcel-L Development](index=3&type=section&id=Remestemcel-L%20Development) Mesoblast provided updates on **remestemcel-L**'s development across multiple indications, including significant progress towards **BLA** resubmission for **SR-aGVHD**, potential collaboration for **ARDS**, and promising early results in **IBD** [Steroid-refractory acute graft versus host disease (SR-aGVHD)](index=3&type=section&id=Steroid-refractory%20acute%20graft%20versus%20host%20disease%20(SR-aGVHD)) The **BLA** resubmission for **remestemcel-L** in children with **SR-aGVHD** is expected by the end of Q3 CY2022, with **FDA** indicating a reasonable approach to **CMC** items. The company has optimized and validated its potency assay, confirmed by data from an expanded access program, and affirmed manufacturing site readiness - **BLA** resubmission to **FDA** for **remestemcel-L** in children with **SR-aGVHD** is expected by the end of Q3 CY2022, with potential US approval in **Q1 CY2023**[7](index=7&type=chunk) - **FDA** has indicated that Mesoblast's approach to address outstanding Chemistry, Manufacturing, and Controls (**CMC**) items is reasonable[7](index=7&type=chunk) - Development and validation work on the potency assay has been completed, and data from an expanded access program (241 children) confirm its ability to measure product activity relevant to survival outcomes[7](index=7&type=chunk) [Acute respiratory distress syndrome (ARDS)](index=3&type=section&id=Acute%20respiratory%20distress%20syndrome%20(ARDS)) Mesoblast is working under an **MOU** with Vanderbilt University Medical Center to potentially collaborate on a second **COVID-19 ARDS** trial. This collaboration aims to design and execute a trial protocol to confirm the previously observed reduction in mortality in **COVID-19 ARDS** patients under 65 years of age - Mesoblast is working under a Memorandum of Understanding (**MOU**) with Vanderbilt University Medical Center for a potential collaboration on a second **COVID-19 ARDS** trial[7](index=7&type=chunk) - The collaboration aims to jointly develop a trial protocol to confirm the observed reduction in mortality in **COVID-19 ARDS** patients under 65 years of age[7](index=7&type=chunk) [Inflammatory bowel disease (IBD)](index=3&type=section&id=Inflammatory%20bowel%20disease%20(IBD)) An investigator-initiated randomized, controlled study of **remestemcel-L** delivered endoscopically is underway for patients with medically refractory ulcerative colitis or Crohn's colitis. The initial 12-patient cohort demonstrated rapid mucosal healing and disease remission compared to placebo - An investigator-initiated randomized, controlled study of **remestemcel-L** for medically refractory ulcerative colitis or Crohn's colitis is underway[7](index=7&type=chunk) - The first 12-patient cohort showed rapid mucosal healing and disease remission compared to placebo in refractory patients[7](index=7&type=chunk) [Rexlemestrocel-L Development](index=3&type=section&id=Rexlemestrocel-L%20Development) Updates on **rexlemestrocel-L** include positive Phase 3 data for **HFrEF**, showing **LVEF** improvement as a potential surrogate endpoint for **MACE** reduction, and alignment with the **FDA** on key metrics for a pivotal Phase 3 study in **CLBP** [Chronic heart failure with reduced ejection fraction (HFrEF)](index=3&type=section&id=Chronic%20heart%20failure%20with%20reduced%20ejection%20fraction%20(HFrEF)) Recent Phase 3 trial data for **rexlemestrocel-L** in **HFrEF** patients showed a single intervention improved left ventricular ejection fraction (**LVEF**) at 12 months, which preceded a long-term reduction in major adverse cardiovascular events (**MACE**). Mesoblast plans to meet with the **FDA** under its **RMAT designation** to discuss these data and a common mechanism of action - Phase 3 trial data (**565 patients**) showed a single intervention with **rexlemestrocel-L** improves left ventricular ejection fraction (**LVEF**) at 12 months, preceding long-term reduction in major adverse cardiovascular events (**MACE**)[7](index=7&type=chunk) - **LVEF** improvement at 12 months may be an appropriate early surrogate endpoint for long-term reduction in **MACE**[7](index=7&type=chunk) - Mesoblast intends to meet with **FDA** next quarter under its **RMAT designation** to discuss data and evidence of a common mechanism of action across the broader **HFrEF** spectrum, including **LVAD** patients[8](index=8&type=chunk) [Chronic low back pain associated with degenerative disc disease (CLBP)](index=5&type=section&id=Chronic%20low%20back%20pain%20associated%20with%20degenerative%20disc%20disease%20(CLBP)) Mesoblast has gained alignment with the **FDA** on key metrics for a pivotal Phase 3 study in **CLBP** patients, aiming to replicate previous significant pain reduction. The primary endpoint for this trial will be a 12-month reduction in pain, with **FDA** clearance to commence expected by **year-end 2022** - Mesoblast gained alignment with the **FDA** on key metrics for a pivotal Phase 3 study in patients with **CLBP**, seeking to replicate significant pain reduction seen in the first Phase 3 trial[13](index=13&type=chunk) - The pivotal trial will have a 12-month reduction in pain as its primary endpoint[13](index=13&type=chunk) - The Company plans to have clearance from the **FDA** by **year-end 2022** to commence the pivotal trial[13](index=13&type=chunk) [Financial Results (FY2022)](index=5&type=section&id=FINANCIAL%20RESULTS%20FOR%20THE%20PERIOD%20ENDED%20JUNE%2030%2C%202022%20(FY2022)) Mesoblast reported a **37% increase** in total revenue for **FY2022**, driven by royalties and milestone revenue, alongside a **35% reduction** in net operating spend and a pro-forma cash position of **US$105.5 million** [Revenue and Profitability](index=5&type=section&id=Revenue%20and%20Profitability) Mesoblast reported a **37% increase** in total revenue for **FY2022**, driven by growth in royalties from **TEMCELL®** and milestone revenue. The company also reduced its net loss after tax and improved basic losses per share compared to the prior fiscal year Total Revenue | Metric | FY2022 (US$M) | FY2021 (US$M) | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenue | 10.2 | 7.5 | 37% | | Royalties from TEMCELL® HS Inj. | 8.7 | 7.2 (est.) | 21% (36% constant currency) | | Milestone revenue (Takeda) | 1.2 | — | N/A | Loss After Tax and EPS | Metric | FY2022 (US$M) | FY2021 (US$M) | Change (%) | | :--- | :--- | :--- | :--- | | Loss after tax | (91.3) | (98.8) | (7.6%) | | Basic losses per share (US cents) | (14.08) | (16.33) | 13.8% | [Operating Expenses](index=5&type=section&id=Operating%20Expenses) Mesoblast significantly reduced its net cash usage for operating activities by **35%** in **FY2022**. This reduction was primarily driven by decreased Research & Development, Manufacturing commercialization, and Management and Administration expenses, reflecting completed clinical trial activities and cost control efforts - Net cash usage for operating activities for the 12 months ended June **FY2022** was **US$65.8 million**, a **35% reduction** relative to the comparative 12 months[13](index=13&type=chunk) Operating Expenses | Expense Category | FY2022 (US$M) | FY2021 (US$M) | Change (%) | | :--- | :--- | :--- | :--- | | Research & Development | 32.8 | 53.0 | (38%) | | Manufacturing commercialization | 30.8 | 32.7 | (6%) | | Management and Administration | 27.2 | 30.9 | (12%) | - Reduction in R&D expenses was due to the completion of clinical trial activities for **COVID-19 ARDS**, **CLBP**, and **CHF** product candidates[13](index=13&type=chunk) [Cash Position and Financing](index=5&type=section&id=Cash%20Position%20and%20Financing) As of June 30, 2022, Mesoblast held **US$60.4 million** in cash, which increased to a pro-forma **US$105.5 million** after a subsequent private placement. The company also has access to additional financing facilities and reported an increase in finance costs for borrowing arrangements Cash and Cash Equivalents | Metric | June 30, 2022 (US$M) | June 30, 2021 (US$M) | | :--- | :--- | :--- | | Cash-on-hand | 60.4 | 136.9 | | Pro-forma (after Aug 2022 private placement) | 105.5 | N/A | - The Company has access to up to an additional **US$40 million** from existing financing facilities, subject to certain milestones[13](index=13&type=chunk) Finance Costs | Metric | FY2022 (US$M) | FY2021 (US$M) | Change (%) | | :--- | :--- | :--- | :--- | | Finance Costs | 17.3 | 10.7 | 61.7% | [About Mesoblast](index=7&type=section&id=About%20Mesoblast) Mesoblast is a global leader in allogeneic cellular medicines, leveraging proprietary technology for late-stage product candidates and holding extensive global intellectual property [Company Overview](index=7&type=section&id=Company%20Overview) Mesoblast is a global leader in allogeneic cellular medicines, utilizing its proprietary mesenchymal lineage cell therapy technology to develop late-stage product candidates for severe inflammatory conditions. The company holds extensive global intellectual property, with products commercialized in Japan and Europe by licensees, and maintains operations in Australia, the United States, and Singapore - Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for severe and life-threatening inflammatory conditions[14](index=14&type=chunk) - The Company leverages its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates[14](index=14&type=chunk) - Mesoblast possesses a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets[15](index=15&type=chunk) - Product candidates include **remestemcel-L** (for **SR-aGVHD**, **IBD**, **ARDS**) and **rexlemestrocel-L** (for advanced chronic heart failure and chronic low back pain), with two products commercialized in Japan and Europe by licensees[16](index=16&type=chunk) [Financial Statements](index=10&type=section&id=Financial%20Statements) This section presents Mesoblast's detailed financial statements for **FY2022**, including income, comprehensive income, balance sheet, and cash flow statements, providing a comprehensive view of its financial performance and position [Consolidated Income Statement](index=10&type=section&id=Consolidated%20Income%20Statement) The Consolidated Income Statement provides a detailed breakdown of Mesoblast's revenues, operating expenses, and net loss for the fiscal years ended June 30, 2022, and 2021, highlighting changes in profitability and cost structures | (in U.S. dollars, in thousands, except per share amount) | Year Ended June 30, 2022 | Year Ended June 30, 2021 | | :--- | :--- | :--- | | Revenue | 10,214 | 7,456 | | Research & development | (32,815) | (53,012) | | Manufacturing commercialization | (30,757) | (32,719) | | Management and administration | (27,210) | (30,867) | | Fair value remeasurement of contingent consideration | 913 | 18,687 | | Fair value remeasurement of warrant liability | 5,896 | — | | Other operating income and expenses | (539) | 1,539 | | Finance costs | (17,288) | (10,714) | | Loss before income tax | (91,586) | (99,630) | | Income tax benefit/(expense) | 239 | 819 | | Loss attributable to the owners of Mesoblast Limited | (91,347) | (98,811) | | Basic - losses per share (Cents) | (14.08) | (16.33) | | Diluted - losses per share (Cents) | (14.08) | (16.33) | [Consolidated Statement of Comprehensive Income](index=10&type=section&id=Consolidated%20Statement%20of%20Comprehensive%20Income) This statement presents the total comprehensive loss for Mesoblast, including the net loss for the period and other comprehensive income or loss items that may or may not be reclassified to profit and loss, such as exchange differences and fair value adjustments | (in U.S. dollars, in thousands) | Year Ended June 30, 2022 | Year Ended June 30, 2021 | | :--- | :--- | :--- | | Loss for the period | (91,347) | (98,811) | | Other comprehensive (loss)/income | | Items that may be reclassified to profit and loss | | Exchange differences on translation of foreign operations | 91 | (1,524) | | Items that will not be reclassified to profit and loss | | Financial assets at fair value through other comprehensive income | (322) | 209 | | Other comprehensive (loss)/income for the period, net of tax | (231) | (1,315) | | Total comprehensive losses attributable to the owners of Mesoblast Limited | (91,578) | (100,126) | [Consolidated Balance Sheet](index=11&type=section&id=Consolidated%20Balance%20Sheet) The Consolidated Balance Sheet provides a snapshot of Mesoblast's financial position as of June 30, 2022, and 2021, detailing its assets, liabilities, and equity, reflecting changes in cash, borrowings, and intangible assets | (in U.S. dollars, in thousands) | As of June 30, 2022 | As of June 30, 2021 | | :--- | :--- | :--- | | **Assets** | | Current Assets | | Cash & cash equivalents | 60,447 | 136,881 | | Trade & other receivables | 4,403 | 4,842 | | Prepayments | 4,987 | 6,504 | | Total Current Assets | 69,837 | 148,227 | | Non-Current Assets | | Property, plant and equipment | 2,045 | 3,021 | | Right-of-use assets | 7,920 | 9,119 | | Financial assets at fair value through other comprehensive income | 1,758 | 2,080 | | Other non-current assets | 1,930 | 1,724 | | Intangible assets | 578,652 | 580,546 | | Total Non-Current Assets | 592,305 | 596,490 | | **Total Assets** | **662,142** | **744,717** | | **Liabilities** | | Current Liabilities | | Trade and other payables | 23,079 | 19,598 | | Provisions | 17,906 | 18,710 | | Borrowings | 5,017 | 53,200 | | Lease liabilities | 3,186 | 2,765 | | Warrant liability | 2,185 | — | | Total Current Liabilities | 51,373 | 94,273 | | Non-Current Liabilities | | Provisions | 12,523 | 17,017 | | Borrowings | 91,617 | 41,045 | | Lease liabilities | 7,085 | 8,485 | | Deferred consideration | 2,500 | 2,500 | | Total Non-Current Liabilities | 113,725 | 69,047 | | **Total Liabilities** | **165,098** | **163,320** | | **Net Assets** | **497,044** | **581,397** | | **Equity** | | Issued Capital | 1,165,309 | 1,163,153 | | Reserves | 70,651 | 65,813 | | (Accumulated losses)/retained earnings | (738,916) | (647,569) | | **Total Equity** | **497,044** | **581,397** | [Consolidated Statement of Cash Flows](index=12&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) The Consolidated Statement of Cash Flows details the cash inflows and outflows from operating, investing, and financing activities for Mesoblast for the fiscal years ended June 30, 2022, and 2021, illustrating the company's liquidity and funding sources | (in U.S. dollars, in thousands) | Year Ended June 30, 2022 | Year Ended June 30, 2021 | | :--- | :--- | :--- | | **Cash flows from operating activities** | | Commercialization revenue received | 9,980 | 6,121 | | Upfront and milestone payments received | — | — | | Government grants and tax incentives received | 24 | 68 | | Payments to suppliers and employees | (75,769) | (106,920) | | Interest received | 7 | 17 | | Income taxes paid | (24) | (35) | | Net cash (outflows) in operating activities | (65,782) | (100,749) | | **Cash flows from investing activities** | | Investment in fixed assets | (157) | (1,647) | | Payments for contingent consideration | — | — | | Payments for licenses | (75) | — | | Net cash (outflows) in investing activities | (232) | (1,647) | | **Cash flows from financing activities** | | Proceeds from borrowings | 51,919 | — | | Repayment of borrowings | (55,458) | — | | Payment of transaction costs from borrowings | (5,527) | (13) | | Interest and other costs of finance paid | (6,084) | (5,932) | | Proceeds from issue of shares | 209 | 106,268 | | Proceeds from issue of warrants | 8,081 | 12,969 | | Payments for share issue costs | (222) | (1,827) | | Payments for lease liabilities | (2,788) | (2,931) | | Net cash (outflows)/inflows by financing activities | (9,870) | 108,534 | | Net (decrease)/increase in cash and cash equivalents | (75,884) | 6,138 | | Cash and cash equivalents at beginning of period | 136,881 | 129,328 | | FX (loss)/gain on the translation of foreign bank accounts | (550) | 1,415 | | Cash and cash equivalents at end of period | 60,447 | 136,881 | [Additional Information](index=7&type=section&id=Additional%20Information) This section includes important disclaimers regarding forward-looking statements and provides essential contact information for corporate, investor, and media inquiries [Forward-Looking Statements](index=7&type=section&id=Forward-Looking%20Statements) This section contains a standard disclaimer regarding forward-looking statements, emphasizing that future events or financial performance involve known and unknown risks and uncertainties. It advises readers not to place undue reliance on these statements and notes that actual results may differ materially - The press release includes forward-looking statements subject to known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially[17](index=17&type=chunk) - Readers are cautioned not to place undue reliance on forward-looking statements, as actual results may differ materially and adversely[17](index=17&type=chunk) - Mesoblast does not undertake any obligations to publicly update or revise any forward-looking statements[17](index=17&type=chunk) [Contact Information](index=9&type=section&id=Contact%20Information) This section provides contact details for corporate communications, investors, and media inquiries, including phone numbers and email addresses for relevant personnel - Contact information for Corporate Communications/Investors (Paul Hughes) and Media (Grant Titmus, Tali Mackay) is provided[20](index=20&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F | REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 | ☐ | | --- | --- | | OR | | | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | ☒ | | For the fiscal year ended June 30, 2022 | | | OR | | | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | ☐ | | OR | | | SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 1 ...

Mesoblast Limited (NASDAQ:MESO) Q4 2022 Earnings Conference Call August 30, 2022 6:30 PM ET Company Participants Silviu Itescu - CEO and MD Andrew Chaponnel - Interim CFO Eric Rose - Chief Medical Officer Conference Call Participants Michael Okunewitch - Maxim Group Edward Tenthoff - Piper Sandler Operator Thank you for standing by. And welcome to the Mesoblast Limited 2022 Full Year Financial Results Conference Call. All participants are in a listen-only mode. A presentation followed by a question-and-answ ...

mesoblast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Operational Highlights & Financial Results for the Year Ended June 30, 2022 August 2022 ASX: MSB; Nasdaq: MESO CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achieve ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 Filed in the month of June 2022 for the period ended March 31, 2022 Commission File Number 001-37626 Mesoblast Limited (Exact name of Registrant as specified in its charter) Not Applicable (Translation of Registrant's name into English) Australia (Jurisdiction of incorporation or organization) Silviu Itescu Chief Executi ...

PART I [Key Information](index=7&type=section&id=Item%203.%20Key%20Information) This section outlines significant financial, clinical, regulatory, and operational risks, emphasizing historical losses and the need for additional funding [Risk Factors](index=7&type=section&id=3.D%20Risk%20Factors) This section details numerous financial, developmental, regulatory, manufacturing, commercialization, and intellectual property risks facing the company - The company incurred operating losses since inception, with a **net loss of $98.8 million** in FY2021 and an **accumulated deficit of $647.6 million**[25](index=25&type=chunk) - Mesoblast requires substantial additional financing to achieve its goals, with cash and cash equivalents at **$136.9 million** as of June 30, 2021[30](index=30&type=chunk) - Product candidates are based on novel mesenchymal lineage cell technology, making development time, cost, and regulatory approval difficult to predict[40](index=40&type=chunk) - The FDA issued a Complete Response Letter for remestemcel-L for pediatric SR-aGVHD in September 2020, recommending at least one additional randomized, controlled study[82](index=82&type=chunk) - The company relies on a single contract manufacturer, Lonza, for product candidate supply, entailing risks related to capacity, quality, and regulatory compliance[101](index=101&type=chunk)[108](index=108&type=chunk) [Information on the Company](index=42&type=section&id=Item%204.%20Information%20on%20the%20Company) This section provides a comprehensive overview of Mesoblast's history, business strategy, technology platforms, product candidates, and regulatory environment [History and Development of Mesoblast](index=42&type=section&id=4.A%20History%20and%20Development%20of%20Mesoblast) This section outlines Mesoblast's corporate history, key clinical and corporate developments, and strategic agreements during fiscal year 2021 - Successfully completed a **$110.0 million private placement** in March 2021, led by a strategic US investor group[217](index=217&type=chunk) - Announced top-line results from the DREAM-HF Phase 3 trial of rexlemestrocel-L in 537 patients with advanced chronic heart failure in December 2020[217](index=217&type=chunk) - Announced results from the Phase 3 trial of rexlemestrocel-L in 404 patients with chronic low back pain due to degenerative disc disease in January 2021[217](index=217&type=chunk) - Entered into a license and collaboration agreement with Novartis in November 2020 for remestemcel-L, initially focusing on ARDS, subject to closing conditions[220](index=220&type=chunk) - Received a Complete Response Letter from the FDA for the Biologics License Application (BLA) for RYONCIL™ (remestemcel-L) in pediatric SR-aGVHD in September 2020, recommending an additional study[221](index=221&type=chunk) [Business Overview](index=45&type=section&id=4.B%20Business%20Overview) Mesoblast's business focuses on proprietary mesenchymal lineage cell therapy, developing off-the-shelf medicines for inflammatory and chronic diseases - Mesoblast developed two late-stage product candidate platforms: Remestemcel-L for systemic inflammatory diseases and Rexlemestrocel-L for localized inflammatory diseases[225](index=225&type=chunk) - The company's technology uses immuno-selected, culture-expanded mesenchymal precursor cells (MPCs) and their progeny, MSCs, sourced from healthy adult donors and administered without matching[227](index=227&type=chunk)[228](index=228&type=chunk) - Two licensee products, TEMCELL (JCR in Japan) and Alofisel® (Takeda in Europe), have been approved, generating royalty income for Mesoblast[235](index=235&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk) - The company holds a large patent portfolio with **approximately 1,089 patents and patent applications** across 77 patent families as of July 2021[289](index=289&type=chunk) [Property, Plants and Equipment](index=67&type=section&id=4.D%20Property,%20Plants%20and%20Equipment) The company leases office and laboratory space in key global locations, with all manufacturing operations conducted by its partner, Lonza - Headquarters are located in leased office space in Melbourne, Australia[397](index=397&type=chunk) - Significant development and commercial activities are conducted from leased space in New York City[397](index=397&type=chunk) - All manufacturing operations are currently located at Lonza's manufacturing facilities[397](index=397&type=chunk) [Operating and Financial Review and Prospects](index=68&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) This section details Mesoblast's FY2021 financial performance, including revenue decline, increased net loss, liquidity, and capital resources [Operating Results](index=68&type=section&id=5.A%20Operating%20Results) FY2021 saw a 77% revenue decrease to $7.5 million and a 27% net loss increase to $98.8 million, driven by non-recurring milestone payments Consolidated Income Statement Data (FY2021 vs. FY2020) | (in thousands of U.S. dollars) | 2021 | 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | **Total revenue** | **$7,456** | **$32,156** | **($24,700)** | **(77%)** | | Research & development | ($53,012) | ($56,188) | $3,176 | (6%) | | Manufacturing commercialization | ($32,719) | ($25,309) | ($7,410) | 29% | | Management and administration | ($30,867) | ($25,609) | ($5,258) | 21% | | Fair value remeasurement of contingent consideration | $18,687 | $1,380 | $17,307 | NM | | Finance costs | ($10,714) | ($14,109) | $3,395 | (24%) | | **Loss before income tax** | **($99,630)** | **($87,355)** | **($12,275)** | **14%** | | Income tax benefit | $819 | $9,415 | ($8,596) | (91%) | | **Loss attributable to owners** | **($98,811)** | **($77,940)** | **($20,871)** | **27%** | - Revenue decrease was primarily due to the absence of **$25.0 million in milestone revenue** in FY2021 from partnerships with Grünenthal and Tasly[420](index=420&type=chunk)[422](index=422&type=chunk) - Commercialization revenue from royalties on sales of TEMCELL in Japan and Alofisel® in Europe increased by **12% to $7.4 million**[421](index=421&type=chunk) - Manufacturing commercialization expenses increased by **$7.4 million (29%)** due to investment in manufacturing readiness for remestemcel-L and potency assay work[431](index=431&type=chunk)[432](index=432&type=chunk) - A fair value remeasurement of contingent consideration resulted in an **$18.7 million gain**, primarily due to revised assumptions following the FDA's Complete Response Letter for remestemcel-L[438](index=438&type=chunk) [Liquidity and Capital Resources](index=78&type=section&id=5.B%20Liquidity%20and%20Capital%20Resources) As of June 30, 2021, Mesoblast held $136.9 million in cash, facing material uncertainty regarding going concern without additional financing - The company's ability to continue as a going concern is dependent on raising additional capital through partnerships or financing, indicating a material uncertainty[478](index=478&type=chunk) Cash and Cash Equivalents | (in thousands of U.S. dollars) | As of June 30, 2021 | | :--- | :--- | | Cash and cash equivalents | $136,881 | Cash Flow Summary (FY2021 vs. FY2020) | (in thousands of U.S. dollars) | 2021 | 2020 | | :--- | :--- | :--- | | Net cash (outflows) in operating activities | (106,681) | (56,365) | | Net cash (outflows) in investing activities | (1,647) | (3,273) | | Net cash inflows by financing activities | 114,466 | 137,044 | | **Net increase in cash and cash equivalents** | **6,138** | **77,406** | - The company has two main loan facilities: **$50.0 million drawn** with Hercules Capital and **$30.0 million drawn** with NovaQuest Capital Management, both with specific covenants[491](index=491&type=chunk)[495](index=495&type=chunk)[502](index=502&type=chunk) [Directors, Senior Management and Employees](index=82&type=section&id=Item%206.%20Directors,%20Senior%20Management%20and%20Employees) This section details the company's leadership, executive compensation strategy, employee demographics, and share ownership by key management personnel [Directors and Senior Management](index=84&type=section&id=6.A%20Directors%20and%20Senior%20Management) The company is led by an experienced Board of Directors and senior management team, including CEO Dr. Silviu Itescu and former CFO Josh Muntner - The Board of Directors is chaired by Joseph Swedish and includes members with significant experience from major pharmaceutical and healthcare companies[524](index=524&type=chunk)[525](index=525&type=chunk)[526](index=526&type=chunk) - Dr. Silviu Itescu serves as the Chief Executive Officer and Executive Director, having founded the company in 2004[537](index=537&type=chunk) - Josh Muntner served as Chief Financial Officer for FY2021 but resigned effective August 31, 2021, with Andrew Chaponnel appointed interim CFO[523](index=523&type=chunk)[538](index=538&type=chunk)[539](index=539&type=chunk) [Compensation](index=91&type=section&id=6.B%20Compensation) The executive remuneration strategy links pay to performance, with a shift towards long-term, performance-based incentives to align with shareholder value - The remuneration framework was significantly changed to reduce cash costs and increase the weighting of long-term, performance-tested options to align executive and shareholder interests[514](index=514&type=chunk) - For FY2021, the CEO's Short-Term Incentive (STI) outcome was **65% of the maximum opportunity**, and the CFO's was **60%**, reflecting mixed objective achievement[513](index=513&type=chunk)[581](index=581&type=chunk) - No Long-Term Incentive (LTI) option tranches became eligible to vest for the CEO in FY2021, as the targeted FDA approval of remestemcel-L did not occur[585](index=585&type=chunk) Statutory Remuneration for Executive KMP (FY2021) | Name | Currency | Base salary | Short term cash bonus | Share based payments | Total Statutory Remuneration | % of performance based remuneration | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Silviu Itescu | A$ | 1,010,000 | 328,250 | 1,207,365 | 2,661,876 | 58% | | Josh Muntner | US$ | 382,000 | 159,771 | 302,898 | 885,900 | 52% | [Employees](index=114&type=section&id=6.D%20Employees) As of June 30, 2021, Mesoblast had 83 global employees, a decrease from the prior year, with the majority based in the United States Employee Count by Year | As of June 30, | 2021 | 2020 | 2019 | | :--- | :--- | :--- | :--- | | **Total Employees** | **83** | **102** | **83** | - In FY2021, **58% of employees** were in the USA, **30%** in Australia, **11%** in Singapore, and **1%** in Switzerland[636](index=636&type=chunk) [Share Ownership](index=115&type=section&id=6.E%20Share%20Ownership) CEO Dr. Silviu Itescu is the largest individual shareholder among KMP, collectively owning 11.4% of outstanding ordinary shares - CEO Silviu Itescu beneficially owned **69,991,374 ordinary shares**, representing **10.8% of the company** as of June 30, 2021[666](index=666&type=chunk)[667](index=667&type=chunk) - All directors and key management personnel as a group (9 persons) beneficially owned **74,250,295 ordinary shares**, representing **11.4% of the company**[666](index=666&type=chunk) [Major Shareholders and Related Party Transactions](index=116&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) This section identifies major shareholders and confirms no related party transactions beyond standard compensation for directors and key management personnel 5% or Greater Shareholders (as of June 30, 2021) | Name | Ordinary Shares Beneficially Owned | % | | :--- | :--- | :--- | | Silviu Itescu | 69,991,374 | 10.8% | | M&G Investment Group | 53,392,209 | 8.2% | | Thorney Holdings | 34,155,365 | 5.3% | - The company has not entered into any related party transactions during the year ended June 30, 2021, other than compensation for Directors and key management personnel[671](index=671&type=chunk) [Financial Information](index=117&type=section&id=Item%208.%20Financial%20Information) This section covers legal proceedings, including a class action lawsuit, and the company's policy of not paying dividends to fund growth - A purported class action lawsuit was filed against the company in the U.S. in October 2020, alleging violations of the U.S. Securities Exchange Act of 1934 following the FDA's Complete Response Letter[673](index=673&type=chunk) - The company has never declared or paid any dividends and does not anticipate paying cash dividends in the foreseeable future, intending to retain all funds for operations and growth[674](index=674&type=chunk) [Additional Information](index=118&type=section&id=Item%2010.%20Additional%20Information) This section provides supplementary corporate information, including material contracts, exchange controls, and taxation relevant to shareholders [Material Contracts](index=123&type=section&id=10.C%20Material%20Contracts) Mesoblast's material contracts include manufacturing agreements with Lonza, commercialization partnerships, and significant non-dilutive loan agreements - **Manufacturing:** Agreements with Lonza for process development and commercial manufacture of product candidates, including remestemcel-L[720](index=720&type=chunk)[725](index=725&type=chunk) - **Grünenthal Partnership:** Strategic partnership to develop and commercialize MPC-06-ID in Europe and Latin America, with **potential milestone payments exceeding $1.0 billion**[727](index=727&type=chunk)[728](index=728&type=chunk) - **JCR Pharmaceuticals Partnership:** Collaboration for MSC products in the Japanese market, including TEMCELL for aGVHD, which generates royalty revenue for Mesoblast[730](index=730&type=chunk)[732](index=732&type=chunk) - **Financing Agreements:** A **$75.0 million credit facility** with Hercules Capital and a **$40.0 million loan agreement** with NovaQuest, secured by company assets and future product revenues, respectively[737](index=737&type=chunk)[739](index=739&type=chunk) PART II [Controls and Procedures](index=136&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of June 30, 2021 - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2021[823](index=823&type=chunk) - Management concluded that its internal control over financial reporting was effective as of June 30, 2021, based on the COSO framework[824](index=824&type=chunk) - There were no changes to internal control over financial reporting during the period that materially affected, or are reasonably likely to materially affect, internal controls[825](index=825&type=chunk) [Corporate Governance](index=137&type=section&id=Item%2016G.%20Corporate%20Governance) As a foreign private issuer, Mesoblast follows Australian corporate governance practices for shareholder meeting quorums instead of Nasdaq rules - As a foreign private issuer, Mesoblast is permitted to follow certain home country (Australian) corporate governance practices instead of certain Nasdaq requirements[834](index=834&type=chunk) - The company follows Australian practice for shareholder meeting quorums, requiring two shareholders present, rather than the Nasdaq rule of at least **33 1/3% of outstanding shares**[836](index=836&type=chunk) PART III [Financial Statements](index=138&type=section&id=Item%2018.%20Financial%20Statements) This section presents audited IFRS financial statements for FY2021, with the auditor highlighting a material uncertainty regarding going concern [Report of Independent Registered Public Accounting Firm](index=139&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor's report expresses substantial doubt about going concern and identifies impairment assessment and contingent consideration as critical audit matters - **Going Concern Uncertainty:** The auditor's report highlights a material uncertainty raising substantial doubt about the company's ability to continue as a going concern, noting the need for additional cash inflows[844](index=844&type=chunk) - **Critical Audit Matter 1:** The impairment assessment of in-process research and development (IPRD) intangible assets (**$427.8 million**) and goodwill (**$134.5 million**) involved significant management judgments regarding future cash flow projections and probabilities of success[852](index=852&type=chunk)[853](index=853&type=chunk) - **Critical Audit Matter 2:** The fair value measurement of the provision for contingent consideration (**$25.4 million**) was a critical audit matter due to significant management judgments in estimating its value, particularly regarding probabilities of success[855](index=855&type=chunk)[856](index=856&type=chunk) [Consolidated Financial Statements](index=143&type=section&id=Consolidated%20Financial%20Statements) FY2021 consolidated financial statements show a $98.8 million net loss, $7.5 million revenue, and $136.9 million cash, with going concern uncertainty Key Financial Statement Figures (as of June 30, 2021) | (in thousands of U.S. dollars) | Amount | | :--- | :--- | | **Income Statement (FY2021):** | | | Total Revenue | $7,456 | | Loss before income tax | ($99,630) | | Net Loss | ($98,811) | | **Balance Sheet:** | | | Cash & cash equivalents | $136,881 | | Intangible assets | $580,546 | | Total Assets | $744,717 | | Borrowings | $94,245 | | Total Liabilities | $163,320 | | Total Equity | $581,397 | - The company's ability to continue as a going concern is noted as a basis of preparation, with management believing it can secure necessary cash inflows despite the material uncertainty[875](index=875&type=chunk) - As of June 30, 2021, pre-launch inventory of **$21.9 million** was recognized on the balance sheet but fully provided for, with costs expensed within Manufacturing Commercialization expenses[1146](index=1146&type=chunk)

WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of even ...

Financial Data and Key Metrics Changes - Total revenue grew nearly 100% to $32.2 million from $16.7 million for the fiscal year ended June 30, 2020 [29][30] - Milestone revenue from strategic partnerships increased by 127% to $25 million from $11 million [30] - Commercialization revenue from JCR Pharmaceuticals rose by 32% to $6.6 million from $5 million [31] - Loss after tax reduced by 13%, driven by increased revenue and reduced clinical trial spending [32] Business Line Data and Key Metrics Changes - RYONCIL, the lead product candidate, is under FDA review for pediatric steroid-refractory acute GVHD, with a PDUFA date set for September 30, 2020 [8][21] - Ongoing Phase 3 trials for remestemcel in acute respiratory distress syndrome from COVID-19, heart failure, and chronic low back pain [9][12][73] - Revenue from JCR Pharmaceuticals for TEMCELL, a product for acute GVHD, is expected to be impacted by production capacity issues [34][36] Market Data and Key Metrics Changes - The addressable U.S. market for acute GVHD in children and adults is approximately eight times larger than in Japan [36] - Pediatric transplants account for about 25% of all bone marrow transplants in the U.S., indicating a significant market opportunity [92] Company Strategy and Development Direction - The company plans to launch RYONCIL in Q4 2020 if approved, with a focus on both pediatric and adult markets for GVHD [21][52] - A lifecycle strategy for remestemcel includes plans for adult steroid-refractory GVHD and COVID-19 ARDS [55][60] - The company is enhancing manufacturing capabilities to meet anticipated demand and is exploring strategic partnerships for commercialization [68] Management's Comments on Operating Environment and Future Outlook - Management highlighted the transformational potential of the upcoming months for the company, emphasizing the importance of RYONCIL's approval [5] - The company is actively engaging with payers regarding pricing and reimbursement strategies for RYONCIL [90] - Management expressed confidence in the demand for RYONCIL based on the experience with TEMCELL in Japan [91] Other Important Information - Cash on hand as of June 30, 2020, was $129.3 million, with an additional $67.5 million potentially available through strategic partnerships [38][39] - The company has a robust patent portfolio with over 1,100 patents and applications, providing strong global protection [18] Q&A Session Summary Question: How should the company model fiscal year 2021? - Management indicated that sales progression for RYONCIL will depend on payer agreements and pricing discussions, with insights drawn from the TEMCELL experience in Japan [90][91] Question: What is the expected year-over-year increase for R&D and SG&A? - Management noted that some costs currently categorized under R&D will shift to SG&A as sales revenue begins [97][99] Question: What was the average age of treated patients in the RYONCIL trial? - The mean age of treated patients was between five and seven, with the label expected to extend up to 18 years [105][106] Question: What is the expected impact of JCR's production and backlog on fiscal 2021 revenues? - Management referenced JCR's guidance indicating a potential drop in TEMCELL sales due to COVID-19, affecting projected royalties [108] Question: Will Grunenthal's Phase 3 trial depend on the company's Phase 3 readout? - Management clarified that the second trial's design will be informed by the totality of data from the current trial, indicating ongoing discussions with regulators [111]

olast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Financial Year Ended June 30, 2020 ASX: MSB; Nasdaq: MESO CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, level ...