[Introduction & Company Overview](index=1&type=section&id=Introduction%20%26%20Company%20Overview) Mesoblast's mission, late-stage pipeline, and investment highlights cover its cell therapy platform and financial position [Cautionary Note Regarding Forward-Looking Statements](index=2&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions that forward-looking statements are subject to risks and uncertainties, advising readers not to unduly rely on them as the company is not obligated to update them - The presentation contains forward-looking statements regarding future events and financial performance, which involve **known and unknown risks and uncertainties**[5](index=5&type=chunk) - Readers should not place undue reliance on these statements, and the company is not obligated to publicly update or revise any forward-looking statements[5](index=5&type=chunk) [Our Mission](index=3&type=section&id=Our%20Mission) Mesoblast's mission is to commercialize innovative cellular therapies for serious and life-threatening illnesses - Mesoblast is committed to commercializing **innovative cellular therapies** for serious and life-threatening illnesses[6](index=6&type=chunk) [Late-Stage Clinical Pipeline](index=4&type=section&id=Late-Stage%20Clinical%20Pipeline) Mesoblast's late-stage pipeline leverages its allogeneic mesenchymal stromal cell platform, with Remestemcel-L and Rexlemestrocel-L in Phase 3 or regulatory filing stages, supported by licensing agreements | Product | Indication | Phase 3 | Regulatory Filing | | :--- | :--- | :--- | :--- | | Remestemcel-L | Pediatric SR-aGVHD | | >> | | Remestemcel-L | Adult SR-aGVHD | >> | | | Rexlemestrocel-L | CLBP | >> | | | Rexlemestrocel-L | HFrEF | >> | | - JCR Pharmaceuticals Co., Ltd. holds rights to develop **mesenchymal stromal cells (MSCs)** in certain fields for the Japanese market, including Graft vs Host Disease and hypoxic ischemic encephalopathy (HIE)[7](index=7&type=chunk) - Grünenthal has an **exclusive license** for rexlemestrocel-L for chronic low back pain in Europe and Latin America/Caribbean, while Tasly Pharmaceuticals holds **exclusive rights** for rexlemestrocel-L for chronic heart failure in China[8](index=8&type=chunk) [Investment Highlights](index=5&type=section&id=Investment%20Highlights) Key investment highlights include Mesoblast's allogeneic cell therapy platform, lead products Remestemcel-L and Rexlemestrocel-L in advanced clinical stages, and a financial position with US$7.5 million revenue and US$71.3 million cash-on-hand - Mesoblast is developing **off-the-shelf, allogeneic cellular medicines** based on proprietary mesenchymal stromal cell (MSC) technology platforms, eliminating the need for donor matching or immunosuppression[10](index=10&type=chunk) - Remestemcel-L is the **lead indication** for children with steroid-refractory acute graft versus host disease (SR-aGVHD), with an upcoming Type A meeting with the FDA to discuss product approval strategy[10](index=10&type=chunk) - Rexlemestrocel-L has completed its first **Phase 3 trial** for discogenic chronic low back pain (CLBP) and for heart failure with reduced ejection fraction (HFrEF) in Class II/III patients, with **RMAT granted by FDA** for end-stage HFrEF patients[10](index=10&type=chunk) | Metric | Value (US$) | | :--- | :--- | | Last 12 months revenue | 7.5 million | | Cash-on-hand (June 30, 2023) | 71.3 million | [Remestemcel-L for Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)](index=6&type=section&id=Remestemcel-L%20for%20Steroid-Refractory%20Acute%20Graft%20Versus%20Host%20Disease%20(SR-aGVHD)) Remestemcel-L's regulatory status and clinical data for pediatric and adult SR-aGVHD are detailed, showing improved survival potential [Regulatory Status for Pediatric SR-aGVHD](index=6&type=section&id=Regulatory%20Status%20for%20Remestemcel-L%20in%20Pediatric%20Patients%20with) The FDA issued a complete response for remestemcel-L's pediatric SR-aGVHD BLA, prompting Mesoblast to schedule a Type A meeting to discuss additional potency assay and adult clinical data - FDA provided a **complete response** to the BLA for remestemcel-L for pediatric SR-aGVHD, requiring demonstration of product similarity between trial and commercial product[12](index=12&type=chunk) - FDA indicated an additional clinical trial would be needed, but Mesoblast proposes providing **additional potency assay data** to establish the link[12](index=12&type=chunk) - A **Type A meeting** with FDA is scheduled for mid-September to discuss providing additional potency assay data and new clinical trial data in adults, which could support the pediatric indication[12](index=12&type=chunk) [Regulatory Status for Adult SR-aGVHD](index=7&type=section&id=Regulatory%20Status%20for%20Remestemcel-L%20in%20Patients%20with%20SR-aGVHI) Mesoblast plans a controlled study for adult SR-aGVHD, a larger market, following promising 63% 100-day survival rates in compassionate access patients, with discussions ongoing with BM CTN - Mesoblast intends to conduct a **targeted, controlled study** in adults with high mortality risk SR-aGVHD, a market approximately **5-fold larger** than children, as part of its commercial strategy[14](index=14&type=chunk) - **100-day survival** was **63%** after remestemcel-L treatment under compassionate access in **71 patients** aged 12 and older with SR-aGVHD who failed at least one additional agent, compared to **20-30%** for those failing agents like ruxolitinib[14](index=14&type=chunk) - Mesoblast is in discussions with world-leading investigators at the **Blood and Marrow Transplant Clinical Trials Network (BM CTN)** to conduct this clinical trial, with costs expected to be covered by planned spending[14](index=14&type=chunk) [Acute Graft Versus Host Disease (aGVHD) Overview](index=13&type=section&id=Acute%20Graft%20Versus%20Host%20Disease%20(aGVHD)) Acute GVHD is a severe, often fatal complication of bone marrow transplants, with SR-aGVHD having high mortality and limited treatment options, especially for children in the US - **Acute GVHD** is a **life-threatening complication** occurring in **~50%** of patients receiving allogeneic BMTs, primarily affecting skin, GI tract, and liver[26](index=26&type=chunk) - **Steroid-refractory aGVHD** is associated with **mortality rates as high as 90%** and significant extended hospital stay costs[26](index=26&type=chunk) - There is only **one approved treatment** for steroid-refractory disease and **no approved treatment in the US for children under 12 years old**; Mesoblast's licensee has the only product approval for SR-aGVHD in Japan for both children and adults[26](index=26&type=chunk) [Remestemcel-L for Children with SR-aGVHD](index=15&type=section&id=Remestemcel-L%20for%20Children%20with%20SR-aGVHD) Remestemcel-L shows improved early and durable survival in children with SR-aGVHD, with 100-day survival rates of 66-79% and 49% survival at 3-4 years | Remestemcel-L Protocol | Remestemcel-L Day 100 Survival | Matched Controls Day 100 Survival | | :--- | :--- | :--- | | Pediatric Subset of Protocol 280 (P3, n=27) | 79% | 54% | | Study 001 (P3, n=54) | 74% | 57% | | Expanded Access Protocol (EAP275, n=241) | 66% | na | | EAP275 (Grade D subset, n=51) | 51% | 31% | | Study | Year 1 Survival | Year 2 Survival | Year 3 Survival | Year 4 Survival | | :--- | :--- | :--- | :--- | :--- | | GVHD001 (Children) | 63% | 51% | 49% | 49% | [Remestemcel-L for Adults with SR-aGVHD](index=17&type=section&id=Remestemcel-L%20for%20Adults%20with%20SR-aGVHD) Mesoblast plans to expand Remestemcel-L to adult SR-aGVHD patients, a larger market, citing 63% 100-day survival in compassionate care, significantly exceeding standard treatments - The commercial strategy is to progress Remestemcel-L to adults who have failed steroids and a first-line agent, including ruxolitinib, as this market opportunity is approximately **five times larger** than the pediatric one[29](index=29&type=chunk) - **Survival** in adults with SR-aGVHD who have failed at least one additional agent, such as ruxolitinib, is **20-30%** by **100 days**, whereas **100-day survival** was **63%** after remestemcel-L treatment under compassionate care in similar patients[29](index=29&type=chunk) - Mesoblast is in discussions with world-leading investigators at the Blood and Marrow Transplant Clinical Trials Network (BM CTN) to conduct a clinical trial in adults, with the costs expected to be covered by planned spending[29](index=29&type=chunk) [Rexlemestrocel-L for Chronic Low Back Pain Due to Degenerative Disc Disease (CLBP)](index=18&type=section&id=Rexlemestrocel-L%20for%20Chronic%20Low%20Back%20Pain%20Due%20to%20Disc%20Disease%20(CLBP)) Rexlemestrocel-L's development for CLBP is detailed, including regulatory status, Phase 3 outcomes, and its potential for this unmet medical need [Chronic Low Back Pain Due to Degenerative Disc Disease (CLBP) Overview](index=19&type=section&id=Chronic%20Low%20Back%20Pain%20Due%20to%20Degenerative%20Disc%20Disease%20(CLBP)) CLBP from degenerative disc disease is a major cause of disability and opioid use, with Rexlemestrocel-L offering a new therapeutic option for over 7 million patients in the U.S. and E.U - Back pain causes **more disability** than any other condition, inflicting substantial direct and indirect costs on the healthcare system, including **excessive use of opioids**[31](index=31&type=chunk) - Minimal treatment options exist for CLBP patients who fail conservative therapy, with **50% of opioid prescriptions** being for CLBP[31](index=31&type=chunk) - Over **7 million patients** are estimated to suffer from CLBP due to degenerative disc disease (DDD) in the U.S. and E.U., representing a **significant market opportunity**[31](index=31&type=chunk) [Rexlemestrocel-L / CLBP - Program Summary](index=20&type=section&id=Rexlemestrocel-L%20%2F%20CLBP%20-%20Program%20Summary) Mesoblast has FDA alignment for a pivotal Phase 3 CLBP study of Rexlemestrocel-L, targeting pain reduction, functional improvement, and reduced opioid use, with manufacturing in place - Mesoblast gained **alignment with the FDA** on the appropriate pivotal **Phase 3 study**, with **mean pain reduction at 12 months** as the primary endpoint[33](index=33&type=chunk) - The product has been manufactured for use in the pivotal Phase 3 study, and **potency assays are in place** for product release[33](index=33&type=chunk) - The program seeks to replicate the **significant reduction in pain** seen at **12 and 24 months** in the first Phase 3 trial, with **functional improvement** and **reduction in opioid use** as secondary endpoints[33](index=33&type=chunk) [RMAT Designation and Phase 3 Trial Outcomes](index=21&type=section&id=Regenerative%20Medicine%20Advanced%20Therapy%20(RMAT)%20Designation%20(FDA%20for%20Rexlemestrocel-L%20in%20the%20treatment%20of%20CLBP)) Rexlemestrocel-L received FDA RMAT designation for CLBP, with Phase 3 trials showing significant and sustained pain reduction, especially in opioid users, and a notable reduction in opioid dependence - Rexlemestrocel-L received **Regenerative Medicine Advanced Therapy (RMAT) designation** from the FDA for CLBP, providing all the benefits of Breakthrough and Fast Track designations[35](index=35&type=chunk) - A single injection of rexlemestrocel-L+HA into the lumbar disc resulted in **significant reduction in pain** compared with saline control at **12 and 24 months** across all subjects (n=404)[35](index=35&type=chunk) - Among patients on opioids at baseline, **28%** who received rexlemestrocel-L+HA were not taking an opioid at **36 months**, compared with **8%** of saline-treated controls[35](index=35&type=chunk) - The **greatest pain reduction** was observed in the pre-specified population of subjects with CLBP duration shorter than the baseline study median of **68 months** (n=202), with significantly greater reduction over **36 months** compared with saline controls[36](index=36&type=chunk) [Rexlemestrocel-L for Chronic Heart Failure with Reduced Ejection Fraction (HFrEF)](index=23&type=section&id=Rexlemestrocel-L%20for%20Chronic%20Heart%20Failure%20Reduced%20Ejection%20Fraction%20(HFrEF)) Rexlemestrocel-L's HFrEF development, clinical results, and potential to improve vascular function and reduce MACE are presented [Rexlemestrocel-L / HFrEF - Program Summary](index=24&type=section&id=Rexlemestrocel-L%20%2F%20HFrEF%20-%20Program%20Summary) Rexlemestrocel-L is developed for HFrEF, addressing a critical unmet need, with DREAM-HF Phase 3 data showing improved LVEF and reduced MACE, especially in inflamed patients - **Cardiovascular disease** remains the **leading cause of death** in the US, and Chronic Heart Failure (CHF) is a progressive disease with high mortality[40](index=40&type=chunk) - Recent data from the **DREAM-HF Phase 3 trial** showed **improved LVEF at 12 months**, preceding long-term reduction in MACE events across all treated patients[40](index=40&type=chunk) - Effects on LVEF and MACE outcomes are enhanced in patients with active inflammation, supporting a mechanism of action by which rexlemestrocel-L reverses **inflammation-related endothelial dysfunction**[40](index=40&type=chunk) [Patients Experience Progressive Vascular Dysfunction and Heart](index=25&type=section&id=Patients%20Experience%20Progressive%20Vascular%20Dysfunction%20and%20Hear) Rexlemestrocel-L has the potential to improve endothelial dysfunction across HFrEF stages (NYHA Class II-IV), offering a novel therapeutic approach for cardiovascular disease - Rexlemestrocel-L has the potential to improve **endothelial dysfunction** in patients with NYHA Class II thru IV HFrEF[41](index=41&type=chunk) - Mesoblast's development program targets patients across the **continuum of cardiovascular disease**, from those on traditional early therapies to those with end-stage HFrEF requiring advanced interventions like LVAD or heart transplant[41](index=41&type=chunk)[42](index=42&type=chunk) [Randomized Trial of Targeted Transendocardial Mesenchymal Precursor Cell Therapy](index=26&type=section&id=Randomized%20Trial%20of%20Targeted%20Transendocardial%20Mesenchymal%20Precursor%20Cell%20Therapy%20in%20Patients%20With%20Heart%20Failure) The DREAM-HF Phase 3 trial showed rexlemestrocel-L improved LVEF and significantly reduced MI, stroke, and MACE risks, particularly in HFrEF patients with active inflammation - **Improved LVEF** from baseline to **12 months** in all patients, with maximal benefit seen in patients with active inflammation[45](index=45&type=chunk) - **Reduced risk of MI or stroke** by **57%** in all treated patients, and by **75%** in patients with inflammation[45](index=45&type=chunk) - **Reduced risk for time-to-first Major Adverse Cardiac Event (MACE)**, defined as cardiovascular death, MI or stroke, by **28%** in all patients, and by **37%** in patients with inflammation[45](index=45&type=chunk) [Two Pivotal Studies in Chronic Heart Failure](index=27&type=section&id=Rexlemestrocel-L%20-%20Two%20Pivotal%20Studies%20in%20Chronic%20Heart%20Failure) Mesoblast is conducting two pivotal studies for Rexlemestrocel-L in HFrEF, targeting both end-stage and chronic patients, using consistent manufacturing and intra-cardiac administration | Study | Patient Population | Cell Dose | Route of Administration | | :--- | :--- | :--- | :--- | | MPC Study | End-stage chronic HFrEF (NYHA Class IIIB or IV) candidate for LVAD implant | 150 million cells | Epicardial injection | | DREAM-HF Study | Chronic HFrEF (NYHA Class II/III) | Not specified in table | Transendocardial | - Both pivotal studies utilize **Mesenchymal Precursor Cells (Rexlemestrocel-L)** with defined Cardiac Potency, employing the same facilities and vendors for cell preparation, manufacturing, central storage, and shipping[46](index=46&type=chunk) - The development programs assess the impact of **intra-cardiac administration** of Rexlemestrocel-L across the continuum of disease from mild/moderate to end-stage HFrEF[46](index=46&type=chunk) [Financial Results and Outlook](index=8&type=section&id=Financial%20Results%20and%20Outlook) Mesoblast's financial performance, including revenue, cash usage, and expenditures, is presented alongside its cost containment plan [Financial Highlights for the Year](index=9&type=section&id=Financial%20Highlights%20for%20the%20Year) Mesoblast reported US$7.5 million in royalty revenue, a 4% reduction in net operating cash usage to US$63.3 million, and US$71.3 million cash-on-hand at June 30, 2023 | Metric | FY2023 (US$ million) | FY2022 (US$ million) | Change | | :--- | :--- | :--- | :--- | | Royalty Revenue | 7.5 | 8.7 | -13.79% | | Net cash usage for operating activities | 63.3 | 65.9 | -4% (reduction) | | Cash-on-hand (June 30, 2023) | 71.3 | | | - **Royalty revenue** from sales of TEMCELL® HS Inj. in Japan by the licensee was **US$8.1 million** for FY2023 on a constant currency basis, compared with **US$8.7 million** for FY2022[16](index=16&type=chunk)[17](index=17&type=chunk) - At June 30, 2023, **cash-on-hand** was **US$71.3 million**, with up to an additional **US$40 million** available from existing financing facilities, subject to certain milestones and extension[16](index=16&type=chunk) [Reduction in Expenditure on R&D, Improved Loss Before Tax](index=10&type=section&id=Reduction%20in%20Expenditure%20on%20R%26D%2C%20Improved%20Loss%20Before%20Tax) Mesoblast reduced its loss before tax to US$82.1 million, driven by a 17% decrease in R&D and a 10% decrease in manufacturing expenditure, despite a decline in total revenue | Metric | June 30, 2023 (US$m) | June 30, 2022 (US$m) | Change (US$m) | | :--- | :--- | :--- | :--- | | Total Revenue | 7.5 | 10.2 | -2.7 | | Research and development | (27.2) | (32.8) | 5.6 | | Manufacturing | (27.7) | (30.8) | 3.1 | | Management & administration | (25.4) | (27.2) | 1.8 | | Loss before tax | (82.1) | (91.6) | 9.5 | | Loss after tax | (81.9) | (91.4) | 9.5 | - **Reduction in R&D expenditure** by **US$5.6 million (17%)** to **US$27.2 million**, primarily supporting preparations for BLA re-submission and pivotal trials for rexlemestrocel-L[18](index=18&type=chunk) - **Reduction in Manufacturing expenditure** by **US$3.1 million (10%)** to **US$27.7 million**, reflecting completion of launch manufacturing activities[19](index=19&type=chunk) [Cost Containment Plan for Next 12 Months](index=11&type=section&id=Cost%20Containment%20Plan%20for%20Next%2012%20Months) Mesoblast targets a 23% reduction (US$15 million) in FY2024 net operating cash spend to US$48.3 million, achieved through reduced spending and a 40% annualized payroll cut - **Targeted 23% reduction (US$15 million)** in annual net operating cash spend from **US$63.3 million** in FY2023 to **US$48.3 million** in FY2024[21](index=21&type=chunk) - This **reduction** is achieved through decreased spend across research, sales & marketing, commercial, and payroll, partially offset by investment in Phase 3 programs for SR-aGVHD and CLBP[21](index=21&type=chunk) - A **40% annualized reduction in payroll** by February 2024, including deferred FY23 short-term incentives for all employees, and voluntary salary reductions/deferred cash payments for CEO, CMO, and Non-Executive Directors, who will receive **long-term non-cash incentives** instead[21](index=21&type=chunk) - Shift from quarterly to half-yearly reporting of Financial Statements from FY2024, with continued quarterly cash and operational reports, in line with ASX-listed entities[21](index=21&type=chunk)

Mesoblast Limited (NASDAQ:MESO) Q4 2023 Results Conference Call August 30, 2023 6:30 PM ET Company Participants Dr. Silviu Itescu - Chief Executive Officer Dr. Eric Rose - Chief Medical Officer Andrew Chaponnel - Interim Chief Financial Officer Dr. Philip Krause - Board Member Conference Call Participants Louise Chen - Cantor Edward Tenthoff - Piper Sandler Sami Corwin - William Blair John Hester - Bell Potter Operator Hello and welcome to the Mesoblast Financial Results for the Period Ended June 30, 2023. ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ______________________________ FORM 20-F ______________________________ o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR o SHELL COMPANY REPORT PUR ...

Table of Contents 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 May 2023 for the period ended March 31, 2023 Commission File Number 001-37626 ________________________________________ Mesoblast Limited (Exact name of Registrant as specified in its charter) ________ ...

Cash Reserves SR-aGVHD is associated with mortality rates as high as 90% mesoblast ASX: MSB; Nasdaq: MESO February 2023 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, levels of activity, performance or achievements expressed or implied by the ...

[Unaudited Financial Statements](index=6&type=section&id=Unaudited%20Financial%20Statements) This section presents the unaudited consolidated financial statements, including income statements, balance sheets, and cash flow statements, for the six months ended December 31, 2022 [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) The unaudited consolidated financial statements for the six months ended December 31, 2022, show a decrease in revenue and a reduced net loss compared to the prior year period, with cash and cash equivalents rising to $67.6 million due to a private placement Consolidated Income Statement Highlights (Six Months Ended Dec 31) | Metric | 2022 (USD thousands) | 2021 (USD thousands) | Change | | :--- | :--- | :--- | :--- | | **Revenue** | 3,636 | 5,977 | -39% | | **Loss before income tax** | (41,496) | (48,732) | -15% | | **Loss attributable to owners** | (41,370) | (48,590) | -15% | | **Basic losses per share (Cents)** | (5.78) | (7.50) | -23% | Consolidated Balance Sheet Highlights | Metric | As of Dec 31, 2022 (USD thousands) | As of June 30, 2022 (USD thousands) | | :--- | :--- | :--- | | **Cash & cash equivalents** | 67,619 | 60,447 | | **Total Assets** | 668,060 | 662,142 | | **Borrowings** | 102,922 | 96,634 | | **Total Liabilities** | 168,058 | 165,098 | | **Total Equity** | 500,002 | 497,044 | Consolidated Statement of Cash Flows Highlights (Six Months Ended Dec 31) | Metric | 2022 (USD thousands) | 2021 (USD thousands) | | :--- | :--- | :--- | | **Net cash outflows in operating activities** | (30,741) | (36,418) | | **Net cash outflows in investing activities** | (237) | (129) | | **Net cash inflows/(outflows) by financing activities** | 38,286 | (5,083) | | **Net increase/(decrease) in cash** | 7,308 | (41,630) | [Notes to Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail the basis of preparation, highlighting a material uncertainty related to the company's ability to continue as a going concern, significant events like a $45.0 million private placement, and revenue primarily from JCR and Takeda royalties - A **material uncertainty** exists that may cast significant doubt on the Group's ability to continue as a going concern, as **additional funding** will be required to meet projected expenditure over the **next 12 months**[33](index=33&type=chunk) - In **August 2022**, the Group completed a **$45.0 million financing** via a global private placement to facilitate launch activities for remestemcel-L and a new Phase 3 trial for rexlemestrocel-L[44](index=44&type=chunk) - On **January 31, 2023**, the Group **resubmitted its Biologics License Application (BLA)** to the FDA for approval of **remestemcel-L** for the treatment of children with **steroid-refractory acute graft-versus-host disease (SR-aGVHD)**[163](index=163&type=chunk) Revenue from Partnerships (Six Months Ended Dec 31) | Partner | Product | 2022 Revenue (USD millions) | 2021 Revenue (USD millions) | | :--- | :--- | :--- | :--- | | JCR | TEMCELL | 3.2 | 4.6 | | Takeda (TiGenix) | Alofisel® | 0.2 | 0.2 | | Takeda (TiGenix) | Milestone | 0.0 | 1.2 | - As of **December 31, 2022**, the company had a minimum remaining financial commitment of **$19.3 million** with manufacturer Lonza, payable until **June 2024**, and **$10.2 million** in other non-cancellable purchase commitments[158](index=158&type=chunk)[159](index=159&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=52&type=section&id=Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial performance, condition, and operational results, highlighting key developments and future outlook [Overview](index=52&type=section&id=Overview) Mesoblast positions itself as a leader in allogeneic cellular medicines with two late-stage platforms, acknowledging a history of significant losses and anticipating continued losses as it prepares for potential commercialization - The company's two primary late-stage product platforms are **remestemcel-L** (for SR-aGVHD, ARDS, IBD) and **rexlemestrocel-L** (for CHF, CLBP)[181](index=181&type=chunk) - Key operational highlights include the **January 31, 2023 resubmission of the BLA for remestemcel-L in SR-aGVHD** and receiving **RMAT designation for rexlemestrocel-L for CLBP**[183](index=183&type=chunk)[184](index=184&type=chunk) - The company had an **accumulated deficit of $780.3 million** as of **December 31, 2022**, and anticipates **continued significant losses** as it moves towards potential commercialization[191](index=191&type=chunk)[346](index=346&type=chunk) [Results of Operations](index=56&type=section&id=Results%20of%20Operations) This section details the financial results for the three and six months ended December 31, 2022, compared to the prior year, showing decreased revenue, reduced R&D expenses, and an improved net loss primarily due to a gain on contingent consideration remeasurement [Comparison for the Three Months Ended December 31, 2022 vs 2021](index=56&type=section&id=Comparison%20for%20the%20Three%20Months%20Ended%20December%2031%2C%202022%20vs%202021) This subsection compares the financial performance for the three months ended December 31, 2022, against the same period in 2021, highlighting changes in revenue, expenses, and net loss Q2 FY23 vs Q2 FY22 Financial Comparison (USD thousands) | Line Item | Q2 2022 | Q2 2021 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | 2,134 | 2,383 | (249) | -10% | | **Research & Development** | (7,683) | (10,198) | 2,515 | -25% | | **Manufacturing Commercialization** | (7,894) | (6,590) | (1,304) | +20% | | **Loss before income tax** | (24,557) | (26,025) | 1,468 | -6% | - The **25% decrease in R&D expenses** was driven by a **$1.8 million reduction** in third-party costs for Phase 3 trials (CLBP, CHF, ARDS) as they transitioned into patient monitoring and data analysis stages[217](index=217&type=chunk)[219](index=219&type=chunk) - Manufacturing commercialization expenses **increased by 20%** primarily due to higher costs for platform technology, potency assay work supporting the aGVHD BLA resubmission, and MSC development activities[226](index=226&type=chunk)[227](index=227&type=chunk) [Comparison for the Six Months Ended December 31, 2022 vs 2021](index=63&type=section&id=Comparison%20for%20the%20Six%20Months%20Ended%20December%2031%2C%202022%20vs%202021) This subsection compares the financial performance for the six months ended December 31, 2022, against the same period in 2021, detailing changes in revenue, expenses, and net loss H1 FY23 vs H1 FY22 Financial Comparison (USD thousands) | Line Item | H1 2022 | H1 2021 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | 3,636 | 5,977 | (2,341) | -39% | | **Research & Development** | (13,430) | (19,526) | 6,096 | -31% | | **Fair value remeasurement of contingent consideration** | 5,989 | (71) | 6,060 | NM | | **Loss before income tax** | (41,496) | (48,732) | 7,236 | -15% | - The **39% decrease in revenue** was due to a **$1.4 million decline in TEMCELL royalties** and the absence of a **$1.2 million milestone payment** from Takeda that was recognized in the prior period[253](index=253&type=chunk)[255](index=255&type=chunk) - The net loss improved partly due to a **$6.0 million gain** on the remeasurement of contingent consideration, resulting from changes in assumptions like probability of payment and development timelines[271](index=271&type=chunk) [Liquidity and Capital Resources](index=69&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2022, Mesoblast held $67.6 million in cash, with a significant inflow from a $45.1 million private placement, but reiterates the need for additional funding to meet future expenditures and address going concern uncertainty Cash Flow Summary (Six Months Ended Dec 31, USD thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | **Operating Activities** | (30,741) | (36,418) | | **Investing Activities** | (237) | (129) | | **Financing Activities** | 38,286 | (5,083) | | **Net Change in Cash** | 7,308 | (41,630) | - The company's **cash position was $67.6 million** as of **December 31, 2022**, with management highlighting a **material uncertainty** regarding its ability to continue as a going concern without additional funding[289](index=289&type=chunk) - The company has a **$90.0 million five-year credit facility** with Oaktree, of which **$60.0 million was drawn** at closing, and in **December 2022**, Oaktree extended the availability of up to an **additional $30.0 million**, subject to milestones[302](index=302&type=chunk) [Risk Factors](index=78&type=section&id=Risk%20Factors) This section outlines various risks that could materially affect the company's business, financial condition, and results of operations, including financial, clinical, regulatory, manufacturing, and other operational challenges [Risks Related to Financial Position and Capital Requirements](index=78&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Capital%20Requirements) This section emphasizes the company's significant financial risks, including a history of substantial operating losses, an accumulated deficit of $780.3 million, and the unlikelihood of achieving profitability in the foreseeable future, necessitating substantial additional financing - The company has incurred operating losses since inception, with an **accumulated deficit of $780.3 million** as of **December 31, 2022**, and anticipates **continued substantial losses**[346](index=346&type=chunk) - There is a **material uncertainty** regarding the company's ability to continue as a going concern, as **additional funding** is required to meet projected expenditures over the **next 12 months**[357](index=357&type=chunk) - The loan facility with Oaktree requires maintaining a **minimum unrestricted cash balance of $35.0 million** in the United States[358](index=358&type=chunk) [Risks Related to Clinical Development and Regulatory Review and Approval](index=81&type=section&id=Risks%20Related%20to%20Clinical%20Development%20and%20Regulatory%20Review%20and%20Approval) The company faces significant risks due to the novel nature of its mesenchymal lineage cell technology, making development timelines and costs difficult to predict, with unpredictable regulatory approval processes, as evidenced by the FDA's September 2020 Complete Response Letter for remestemcel-L - The **novelty of the company's cell therapy platform** makes it **difficult to predict development time, cost, and the likelihood of regulatory approval**[363](index=363&type=chunk) - In **September 2020**, the FDA issued a **Complete Response Letter** for the **remestemcel-L BLA**, recommending at least one **additional randomized, controlled study** despite a positive ODAC vote[405](index=405&type=chunk) - The **BLA for remestemcel-L was resubmitted on January 31, 2023**, with an anticipated **six-month review period** if accepted by the FDA, but **approval is not guaranteed**[406](index=406&type=chunk) [Risks Related to Manufacturing and Supply Chain](index=93&type=section&id=Risks%20Related%20to%20Manufacturing%20and%20Supply%20Chain) Mesoblast has no experience manufacturing its products at a commercial scale and is entirely dependent on its contract manufacturer, Lonza, creating risks related to production capacity, quality control, pricing, and potential supply disruptions, further complicated by reliance on a limited number of suppliers for critical raw materials - The company has **no internal manufacturing capability** and is **dependent on its contract manufacturer, Lonza**, for the supply of its product candidates for both clinical and potential commercial use[425](index=425&type=chunk)[432](index=432&type=chunk) - The manufacturing process relies on a **limited number of suppliers** for **critical materials**, including **fetal bovine serum (FBS)**, which could be subject to supply interruptions[437](index=437&type=chunk)[466](index=466&type=chunk) - Supply chain and manufacturing could be adversely affected by **geopolitical instability, climate events, and the COVID-19 pandemic**, potentially increasing costs and causing delays[431](index=431&type=chunk) [Other Risks](index=91&type=section&id=Other%20Risks) This section consolidates various other risks, including reliance on collaborators, commercialization challenges, intellectual property uncertainties, and business/industry risks, alongside a shareholder class action lawsuit and high dependence on key personnel - The company is **highly dependent on key personnel**, particularly **CEO Dr. Silviu Itescu**, a pioneer in the field of cell therapeutics[485](index=485&type=chunk) - A **shareholder class action lawsuit** was filed against the company in Australia in **mid-2022**, relating to the **FDA's Complete Response Letter** for its GvHD product and representations made about its COVID-19 candidate[520](index=520&type=chunk) - Future commercial success is **highly dependent on obtaining adequate coverage and reimbursement** from government and private payors, which is **uncertain for novel, potentially high-cost cell therapies**[454](index=454&type=chunk)[460](index=460&type=chunk)

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 ...