meso-6k_20190208.htm

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

For the month of February 2019

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 Executive Officer and Executive Director

Level 38

55 Collins Street

Melbourne 3000

Australia

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F:

Form 20-F Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Yes No

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

Yes No

 


INFORMATION CONTAINED ON THIS REPORT ON FORM 6-K

On February 21, 2019, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement and investor presentation, which are attached hereto as Exhibit 99.1 and Exhibit 99.2, and is incorporated herein by reference.


 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly organized.

 

 

 

 

 

 

 

 

Mesoblast Limited

 

 

 

 

 

 

/s/ Charlie Harrison

 

 

 

 

 

 

 

 

 

Charlie Harrison

 

 

 

 

Company Secretary

 

 

 

Dated: February 21, 2019


INDEX TO EXHIBITS

 

 

 

Item

 

 

 

 

 

99.1

 

Press release of Mesoblast Ltd, dated February 21, 2019.

99.2

 

Investor presentation of Mesoblast Ltd, dated February 21, 2019.

 

 

 

meso-ex991_11.htm

Exhibit 99.1

 

 

 

 

MESOBLAST REPORTS FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS

FOR THE FIRST HALF ENDED DECEMBER 31, 2018

 

Strong cash reserves as Company prepares for potential US launch of remestemcel-L

 

Melbourne, Australia, February 21, 2019 and New York, USA, February 20, 2019: Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today reported its financial results and operational highlights for the six months ended December 31, 2018.  Pro-forma cash on hand at December 31, 2018 was US$92.0 million (A$130.0 million).

Chief Executive Dr Silviu Itescu said: “The highlights from the half year include completion of enrollment in our major cardiovascular Phase 3 trial, execution of our cardiovascular partnership in China, and continued revenue growth from product sales by our licensee in Japan for treatment of acute graft versus host disease (aGVHD). Our focus in the coming period is on obtaining FDA approval for and ensuring a successful commercial launch of remestemcel-L for aGVHD in the United States.”

 

Corporate Highlights for the Six Months Ended December 31, 2018 (first half FY2019):

 

 

After demonstrating strong survival benefits through Day 180, Mesoblast held two successful end-of-phase meetings with the FDA covering clinical and manufacturing aspects of the upcoming Biologics License Application (BLA) for remestemcel-L in the US for use in children with steroid-refractory aGVHD.  

 

 

The Company now has a meeting scheduled with the FDA in April 2019 and is on track to subsequently initiate a BLA filing for marketing authorization.  

 

 

Mesoblast’s Phase 3 trial in chronic heart failure completed patient enrollment, with 566 patients randomized to receive Revascor or placebo. The study, conducted across 55 centers in North America, will complete when sufficient primary endpoint events have accrued, which is likely to be within 12 months.

 

 

Mesoblast completed its transaction with Tasly Pharmaceutical Group (Tasly) to establish a strategic cardiovascular partnership in China, and received US$40 million on closing.

 

 

Mesoblast and Tasly held their first Joint Steering Committee meeting, with a shared objective to initiate a clinical study in China using similar clinical endpoints and targeting a similar patient population as in Mesoblast’s North American Phase 3 trial. Tasly and Mesoblast will leverage each other’s clinical trial results to support their respective regulatory submissions.

 

 

The National Institutes of Health (NIH) sponsored 159-patient trial of Revascor in end-stage heart failure patients with a left ventricular assist device (LVAD) achieved a 76% reduction in major gastrointestinal (GI) bleeding events and a 65% reduction in associated hospitalizations. Under the Regenerative Medicine Advanced Therapy (RMAT) designation for this indication, Mesoblast has received guidance from the FDA that reduction in GI bleeding and related hospitalizations is a clinically meaningful outcome that could support product registration.

 

 

Mesoblast has expanded its partnership with Japan’s JCR Pharmaceuticals Co. Ltd. (JCR) for the treatment of wound healing in epidermolysis bullosa (EB). Having been granted Orphan Regenerative Medical Product designation for EB in October, JCR now intends to seek a label extension for TEMCELL®1 HS. Inj. in Japan for EB beyond its existing approval for the treatment of aGVHD.

 

 

Management has been expanded to build a commercial team to support the Company’s launch plans for remestemcel-L and operational leadership to drive product life cycle management, commercial manufacturing and regulatory interactions.

 

 

Mesoblast Limited
ABN 68 109 431 870

 

www.mesoblast.com

Corporate Headquarters

Level 38

55 Collins Street

Melbourne 3000

Victoria Australia

 

T +61 3 9639 6036

F +61 3 9639 6030

United States Operations

505 Fifth Avenue

Third Floor

New York, NY 10017

USA

 

T +1 212 880 2060

F +1 212 880 2061

Asia

20 Biopolis Way

#05-01 Centros

Biopreneur 3

SINGAPORE 138668

 

T +65 6570 0635

F +65 6570 0176

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

The Board of Directors is undergoing a structured succession plan and has brought on two new US-based Directors with proven expertise in product commercial launches, reimbursement and health system economics.

 

Upcoming Milestones in Second Half FY2019:

 

 

Mesoblast intends to initiate BLA filing for marketing authorization of remestemcel-L following its FDA meeting scheduled for April 2019.

 

 

Mesoblast’s partner Tasly is planning to meet with the National Medical Products Administration of China to discuss the regulatory approval pathway for Revascor in China.

 

 

Mesoblast intends to meet with the FDA to discuss the pathway for approval of Revascor for the reduction in GI bleeding in patients with LVADs.

 

 

All patients in Mesoblast’s Phase 3 trial in MPC-06-ID for chronic lower back pain will complete their 12-month assessment for safety and efficacy.

 

Key Financial Highlights for First Half FY2019:

 

 

Pro forma cash of US$92.0 million at December 31, 2018.

 

 

o

This includes US$15.0 million received in January 2019 from Hercules Capital, Inc. (Hercules) after having successfully achieved the clinical milestone of reduction in major GI bleeding events and related hospitalizations in the NIH trial of Revascor in end stage heart failure patients with LVADs;

 

 

o

Additional non-dilutive capital of US$35.0 million may be available under existing arrangements with Hercules and NovaQuest Capital Management, L.L.C. (NovaQuest), subject to certain milestones.

 

 

43% increase in royalty income on sales of TEMCELL for aGVHD in Japan.

 

 

Stable revenue of US$13.5 million, compared with US$14.6 million in the first half of FY2018.

 

 

Increased investment in commercial manufacturing of US$8.0 million in preparation for potential aGVHD approval.

 

 

50% reduction in net operating cash outflows in the first half of FY2019 to US$17.5 million.  

 

Detailed Financial Results for the Six Months Ended December 31, 2018 (first half FY2019):

 

 

Revenues were US$13.5 million for the first half FY2019, compared with US$14.6 million for the first half FY2018, a decrease of US$1.1 million primarily due to:

 

 

o

US$10.0 million milestone revenue recognized in the first half FY2019 in relation to establishing a partnership with Tasly in China, compared with US$11.8 million milestone revenue recognized in the first half FY2018 in relation to the patent license agreement with Takeda Pharmaceutical Company Limited.

 

 

o

US$3.2 million royalties and milestones revenue recognized in the first half FY2019 from sales of TEMCELL by our licensee in Japan, JCR, compared with US$2.6 million in the first half FY2018, an increase of US$0.6 million. Royalty income from TEMCELL increased by 43% for the first half FY2019.

 

 

Research and Development expenses were US$34.0 million for the first half FY2019, compared with US$31.6 million for the first half FY2018, an increase of US$2.4 million (8%) as the Company invested in its lead clinical programs.

 

 

 

Mesoblast Limited
ABN 68 109 431 870

 

www.mesoblast.com

Corporate Headquarters

Level 38

55 Collins Street

Melbourne 3000

Victoria Australia

 

T +61 3 9639 6036

F +61 3 9639 6030

United States Operations

505 Fifth Avenue

Third Floor

New York, NY 10017

USA

 

T +1 212 880 2060

F +1 212 880 2061

Asia

20 Biopolis Way

#05-01 Centros

Biopreneur 3

SINGAPORE 138668

 

T +65 6570 0635

F +65 6570 0176

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

Manufacturing expenses were US$9.7 million for the first half FY2019, compared with US$1.7 million for the first half FY2018, an increase of US$8.0 million due to an increase in commercial manufacturing in preparation for GVHD approval.

 

 

Management and Administration expenses were US$10.7 million for the first half FY2019, compared with US$10.6 million for the first half FY2018, an increase of only US$0.1 million (1%).

 

 

Finance Costs of US$5.1 million related to loan and security agreements entered into with Hercules in March 2018 and NovaQuest in June 2018. No interest expense was recognized in the first half FY2018.

 

Additional components of loss after income tax also include movements in other items which did not impact current cash reserves, such as income tax benefits, fair value remeasurement of contingent consideration, remeasurement of borrowing arrangements and foreign exchange movements within other operating income and expenses.

 

In the first half FY2019 the Company reported a US$44.1 million loss after tax compared to a profit after tax of US$6.7 million for the first half FY2018. The increase in the loss is primarily due to, in the current period, investment in commercial manufacturing of US$8.0 million in preparation for GVHD approval, and an increase of US$5.1 million in finance costs; and in comparison period of first half FY2018 the Company recognized a one-off non-cash income tax benefit of US$23.0 million due to a revaluation of tax liabilities given changes in tax rates and a non-cash US$8.7 million gain on contingent consideration for reduction of future payments to third parties. The net loss attributable to ordinary shareholders was 9.08 cents loss per share, for the first half FY2019, compared with 1.46 cents earnings per share, for the first half of FY2018.  

 

1TEMCELL® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.

 

Conference Call Details

There will be a webcast today on the financial results beginning at 4.30pm on Wednesday, February 20 EST; 8:30am on Thursday, February 21, 2019 AEDT.  

 

The live webcast can be accessed via https://webcasting.boardroom.media/broadcast/5c6107137e5a7b7d6e8941e4

 

To access the call only, dial 1 855 881 1339 (U.S.), 1 800 558 698 (toll-free Australia) or +61 2 9007 3187 (outside of the U.S. and Australia). The conference identification code is 774100.

 

The archived webcast will be available on the Investor page of the Company’s website: www.mesoblast.com

 

About Mesoblast

Mesoblast Limited (ASX: MSB; Nasdaq: MESO) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary technology platform to establish a broad portfolio of late-stage product candidates with three product candidates in Phase 3 trials – acute graft versus host disease, chronic heart failure and chronic low back pain due to degenerative disc disease. Through a proprietary process, Mesoblast selects rare mesenchymal lineage precursor and stem cells from the bone marrow of healthy adults and creates master cell banks, which can be industrially expanded to produce thousands of doses from each donor that meet stringent release criteria, have lot to lot consistency, and can be used off-the-shelf without the need for tissue matching. Mesoblast has facilities in Melbourne, New York, Singapore and Texas and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). www.mesoblast.com

 

 

 

Mesoblast Limited
ABN 68 109 431 870

 

www.mesoblast.com

Corporate Headquarters

Level 38

55 Collins Street

Melbourne 3000

Victoria Australia

 

T +61 3 9639 6036

F +61 3 9639 6030

United States Operations

505 Fifth Avenue

Third Floor

New York, NY 10017

USA

 

T +1 212 880 2060

F +1 212 880 2061

Asia

20 Biopolis Way

#05-01 Centros

Biopreneur 3

SINGAPORE 138668

 

T +65 6570 0635

F +65 6570 0176

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Forward-Looking Statements

This announcement 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 these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

 

For further information, please contact:

 

Julie Meldrum

Schond Greenway

Corporate Communications

Investor Relations

Mesoblast

Mesoblast

T: +61 3 9639 6036

T: +1 212 880 2060

E: [email protected]

E: [email protected]

 

 

 

Mesoblast Limited
ABN 68 109 431 870

 

www.mesoblast.com

Corporate Headquarters

Level 38

55 Collins Street

Melbourne 3000

Victoria Australia

 

T +61 3 9639 6036

F +61 3 9639 6030

United States Operations

505 Fifth Avenue

Third Floor

New York, NY 10017

USA

 

T +1 212 880 2060

F +1 212 880 2061

Asia

20 Biopolis Way

#05-01 Centros

Biopreneur 3

SINGAPORE 138668

 

T +65 6570 0635

F +65 6570 0176

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Consolidated Income Statement

 

 

 

Three Months Ended

December 31,

 

Six Months Ended

December 31,

 

(in U.S. dollars, in thousands, except per share amount)

 

2018

 

 

2017

 

2018

 

 

2017

 

Revenue

 

 

1,870

 

 

 

13,397

 

 

13,507

 

 

 

14,571

 

Research & development

 

 

(15,488

)

 

 

(16,222

)

 

(33,975

)

 

 

(31,590

)

Manufacturing commercialization

 

 

(5,401

)

 

 

(801

)

 

(9,717

)

 

 

(1,678

)

Management and administration

 

 

(5,126

)

 

 

(5,643

)

 

(10,742

)

 

 

(10,655

)

Fair value remeasurement of contingent consideration

 

 

(11

)

 

 

(793

)

 

(634

)

 

 

8,702

 

Other operating income and expenses

 

 

(827

)

 

 

423

 

 

(978

)

 

 

1,091

 

Finance costs

 

 

(2,486

)

 

 

 

 

(5,139

)

 

 

 

Loss before income tax

 

 

(27,469

)

 

 

(9,639

)

 

(47,678

)

 

 

(19,559

)

Income tax benefit

 

 

2,865

 

 

 

23,342

 

 

3,575

 

 

 

26,240

 

(Loss)/profit attributable to the owners of Mesoblast Limited

 

 

(24,604

)

 

 

13,703

 

 

(44,103

)

 

 

6,681

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Losses)/earnings per share from continuing operations attributable

   to the ordinary equity holders of the Group:

 

Cents

 

 

Cents

 

Cents

 

 

Cents

 

Basic - (losses)/earnings per share

 

 

(5.00

)

 

 

2.91

 

 

(9.08

)

 

 

1.46

 

Diluted - (losses)/earnings per share

 

 

(5.00

)

 

 

2.91

 

 

(9.08

)

 

 

1.46

 

 

Consolidated Statement of Comprehensive Income

 

 

 

Three Months Ended

December 31,

 

Six Months Ended

December 31,

 

(in U.S. dollars, in thousands)

 

2018

 

 

2017

 

2018

 

 

2017

 

(Loss)/profit for the period

 

 

(24,604

)

 

 

13,703

 

 

(44,103

)

 

 

6,681

 

Other comprehensive (loss)/income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Items that may be reclassified to profit and loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Changes in the fair value of financial assets

 

 

108

 

 

 

47

 

 

195

 

 

 

67

 

Exchange differences on translation of foreign operations

 

 

(160

)

 

 

(385

)

 

(183

)

 

 

(500

)

Other comprehensive (loss)/income for the period,

   net of tax

 

 

(52

)

 

 

(338

)

 

12

 

 

 

(433

)

Total comprehensive (losses)/income attributable to the

   owners of Mesoblast Limited

 

 

(24,656

)

 

 

13,365

 

 

(44,091

)

 

 

6,248

 

 

 

 

Mesoblast Limited
ABN 68 109 431 870

 

www.mesoblast.com

Corporate Headquarters

Level 38

55 Collins Street

Melbourne 3000

Victoria Australia

 

T +61 3 9639 6036

F +61 3 9639 6030

United States Operations

505 Fifth Avenue

Third Floor

New York, NY 10017

USA

 

T +1 212 880 2060

F +1 212 880 2061

Asia

20 Biopolis Way

#05-01 Centros

Biopreneur 3

SINGAPORE 138668

 

T +65 6570 0635

F +65 6570 0176

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Consolidated Statement of Balance Sheet

 

 

 

 

 

 

 

 

 

 

(in U.S. dollars, in thousands)

 

As of

December 31,

2018

 

 

As of

June 30,

2018

 

Assets

 

 

 

 

 

 

 

 

Current Assets

 

 

 

 

 

 

 

 

Cash & cash equivalents

 

 

77,022

 

 

 

37,763

 

Trade & other receivables

 

 

3,934

 

 

 

50,366

 

Prepayments

 

 

16,845

 

 

 

12,942

 

Total Current Assets

 

 

97,801

 

 

 

101,071

 

 

 

 

 

 

 

 

 

 

Non-Current Assets

 

 

 

 

 

 

 

 

Property, plant and equipment

 

 

871

 

 

 

1,084

 

Financial assets at fair value through other comprehensive income

 

 

2,516

 

 

 

2,321

 

Other non-current assets

 

 

3,330

 

 

 

3,361

 

Intangible assets

 

 

583,815

 

 

 

584,606

 

Total Non-Current Assets

 

 

590,532

 

 

 

591,372

 

Total Assets

 

 

688,333

 

 

 

692,443

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Trade and other payables

 

 

25,120

 

 

 

18,921

 

Provisions

 

 

5,594

 

 

 

5,082

 

Borrowings

 

 

3,095

 

 

 

 

Total Current Liabilities

 

 

33,809

 

 

 

24,003

 

 

 

 

 

 

 

 

 

 

Non-Current Liabilities

 

 

 

 

 

 

 

 

Deferred tax liability

 

 

16,504

 

 

 

20,079

 

Deferred consideration

 

 

10,000

 

 

 

 

Provisions

 

 

43,076

 

 

 

42,956

 

Borrowings

 

 

60,387

 

 

 

59,397

 

Total Non-Current Liabilities

 

 

129,967

 

 

 

122,432

 

Total Liabilities

 

 

163,776

 

 

 

146,435

 

Net Assets

 

 

524,557

 

 

 

546,008

 

 

 

 

 

 

 

 

 

 

Equity

 

 

 

 

 

 

 

 

Issued Capital

 

 

909,235

 

 

 

889,481

 

Reserves

 

 

39,617

 

 

 

36,719

 

(Accumulated losses)/retained earnings

 

 

(424,295

)

 

 

(380,192

)

Total Equity

 

 

524,557

 

 

 

546,008

 

 

 

 

Mesoblast Limited
ABN 68 109 431 870

 

www.mesoblast.com

Corporate Headquarters

Level 38

55 Collins Street

Melbourne 3000

Victoria Australia

 

T +61 3 9639 6036

F +61 3 9639 6030

United States Operations

505 Fifth Avenue

Third Floor

New York, NY 10017

USA

 

T +1 212 880 2060

F +1 212 880 2061

Asia

20 Biopolis Way

#05-01 Centros

Biopreneur 3

SINGAPORE 138668

 

T +65 6570 0635

F +65 6570 0176

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Consolidated Statement of Cash Flows

 

 

 

Six months ended

December 31,

 

(in U.S. dollars, in thousands)

 

2018

 

 

2017

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

Commercialization revenue received

 

 

2,101

 

 

 

1,080

 

Milestone payment received

 

 

26,409

 

 

 

6,125

 

Research and development tax incentive received

 

 

1,654

 

 

 

 

Payments to suppliers and employees (inclusive of goods and

   services tax)

 

 

(46,186

)

 

 

(42,593

)

Interest received

 

 

293

 

 

 

192

 

Interest paid

 

 

(1,783

)

 

 

 

Income taxes (paid)/refunded

 

 

(3

)

 

 

(25

)

Net cash (outflows) in operating activities

 

 

(17,515

)

 

 

(35,221

)

 

 

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

 

 

Investment in fixed assets

 

 

(112

)

 

 

(137

)

Payments for contingent consideration

 

 

 

 

 

(543

)

Net cash (outflows) in investing activities

 

 

(112

)

 

 

(680

)

 

 

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

 

 

Proceeds from borrowings

 

 

28,950

 

 

 

 

Payments of transaction costs from borrowings

 

 

(1,546

)

 

 

 

Proceeds from issue of shares

 

 

30,258

 

 

 

40,532

 

Payments for share issue costs

 

 

(607

)

 

 

(2,603

)

Net cash inflows by financing activities

 

 

57,055

 

 

 

37,929

 

 

 

 

 

 

 

 

 

 

Net increase in cash and cash equivalents

 

 

39,428

 

 

 

2,028

 

Cash and cash equivalents at beginning of period

 

 

37,763

 

 

 

45,761

 

FX (losses) on the translation of foreign bank accounts

 

 

(169

)

 

 

(403

)

Cash and cash equivalents at end of period

 

 

77,022

 

 

 

47,386

 

 

 

 

 

Mesoblast Limited
ABN 68 109 431 870

 

www.mesoblast.com

Corporate Headquarters

Level 38

55 Collins Street

Melbourne 3000

Victoria Australia

 

T +61 3 9639 6036

F +61 3 9639 6030

United States Operations

505 Fifth Avenue

Third Floor

New York, NY 10017

USA

 

T +1 212 880 2060

F +1 212 880 2061

Asia

20 Biopolis Way

#05-01 Centros

Biopreneur 3

SINGAPORE 138668

 

T +65 6570 0635

F +65 6570 0176

 

 

 

 

 

 

 

 

 

 

 

 

 

meso-ex992_56.pptx.htm

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February 2019 Nasdaq: MESO ASX: MSB Operational Highlights and Financial Results for the Half Year Ended December 31, 2018 Exhibit 99.2

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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, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” “could,” and similar expressions or phrases identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and future events , recent changes in regulatory laws, and financial trends that we believe may affect our financial condition, results of operation, business strategy and financial needs. These statements may relate to, but are not limited to: expectations regarding the safety or efficacy of, or potential applications for, Mesoblast's adult stem cell technologies; expectations regarding the strength of Mesoblast's intellectual property, the timeline for Mesoblast's regulatory approval process, and the scalability and efficiency of manufacturing processes; expectations about Mesoblast's ability to grow its business and statements regarding its relationships with current and potential future business partners and future benefits of those relationships; statements concerning Mesoblast's share price or potential market capitalization; and statements concerning Mesoblast's capital requirements and ability to raise future capital, among others. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. You should read this presentation together with our financial statements and the notes related thereto, as well as the risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, include, without limitation: risks inherent in the development and commercialization of potential products; uncertainty of clinical trial results or regulatory approvals or clearances; government regulation; the need for future capital; dependence upon collaborators; and protection of our intellectual property rights, among others. Accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. | 2

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Our Mission Mesoblast is committed to bring to market innovative cellular medicines to treat serious and life-threatening illnesses |

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Premier Global Cellular Medicines Company Commercialization Innovative Technology Platform1 Innovative technology targets the most severe disease states refractory to conventional therapies Well characterized multimodal mechanisms of action Underpinned by extensive, global IP estate Building focused U.S. sales force for GVHD product launch Industrial-scale manufacturing to meet commercial demand First approved products commercialized by licensees in Japan2 and Europe3 Increasing revenues and milestone payments Mesenchymal precursor cells (MPCs) and their culture-expanded progeny mesenchymal stem cells (MSCs). Licensee JCR Pharmaceuticals Co., Ltd. received the first full PMDA approval for an allogeneic cellular medicine in Japan and markets this product under its trademark, TEMCELL® Hs Inj. Licensee Takeda received first central marketing authorization approval from the European Commission for an allogeneic stem cell therapy and markets this product under its trademark, Alofisel®. Late Stage Pipeline Upcoming BLA submission for Steroid-Refractory Acute GVHD 2 blockbuster product candidates completed Phase 3 trial enrollment - heart failure and back pain China cardiovascular partnership established

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Corporate Highlights for the Half Year Remestemcel-L for Steroid Refractory Acute Graft Versus Host Disease After demonstrating strong survival benefits through Day 180, held two successful end-of-phase meetings with the FDA covering clinical and manufacturing aspects of the upcoming BLA filing Meeting scheduled with the FDA in April 2019 and on track to subsequently initiate filing Building an efficient and targeted sales force for product launch Revascor for Advanced and End-Stage Heart Failure Phase 3 trial in chronic heart failure completed patient enrollment, with 566 patients randomized, and will complete when sufficient primary endpoint events have accrued, which is likely to be within 12 months First Joint Steering Committee meeting held with Tasly, objective to initiate a clinical study in China using similar clinical endpoints and targeting a similar patient population as in Mesoblast’s North American Phase 3 trial NIH sponsored 159-patient trial of Revascor in end-stage heart failure patients with an LVAD achieved a 76% reduction in major GI bleeding events and a 65% reduction in associated hospitalizations FDA provided guidance that reduction in GI bleeding and related hospitalizations is a clinically meaningful outcome that could support product registration

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Financial Strengthened cash position through both corporate transactions and strategic financing - US$92 million pro forma cash on hand Completed transaction with Tasly to establish a cardiovascular partnership in China, and received US$40 million Ramp up of manufacturing investment in preparation for registration and launch of remestemcel-L Increased product royalties from licensees Board of Directors – Structured Succession Plan to Bring Complementary Skills Proven FDA product approval capabilities, commercial launch expertise, reimbursement and health system expertise and extensive global transactional record Management – Expand to Support Commercial Launch Plans Commercial leadership with proven track record to roll out launch team Operational leadership to drive product life cycle management, commercial manufacturing and regulatory interactions Corporate Highlights for the Half Year

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Financials |

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Pro forma cash on hand at December 31, 2018 includes US$15.0 million received in January 2019 from Hercules Capital, Inc. after having successfully achieved the clinical milestone of reduction in major gastrointestinal bleeding (GI) events and related hospitalizations in the 159 patient trial of Mesoblast’s product candidate Revascor in end stage heart failure patients with LVADs An additional US$35.0 million may be available under existing arrangements with Hercules Capital and NovaQuest, subject to achievement of certain milestones US$m December 31, 2018 June 30, 2018 Reported Cash on Hand 77.0 37.8 NovaQuest financing agreement - 39.0 Tasly strategic partnership - 40.0 Hercules – 2nd tranche 15.0 - Pro forma cash on hand 92.0 116.8 Pro Forma Cash Position of US$92 million |

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` For the six months ending (US$m) December 31, 2018 December 31, 2017 Operating net cash outflows (17.5) (35.2) Investing net cash outflows (0.1) (0.7) Financing net cash inflows 57.0 37.9 Net increase in cash 39.4 2.0 50% (US$17.7 million) reduction in net operating cash outflows for the six months ended December 31, 2018, primarily due to the timing of receipts of milestone payments Increase in financing net cash inflows from strategic transactions with Tasly and Novaquest Significant reduction in Operating Net Cash Outflows |

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| 11 For the six months ending (US$m) December 31, 2018 December 31, 2017 Milestone revenue 11.0 12.8 Commercialization revenue 2.2 1.6 Interest revenue 0.3 0.2 Total revenue 13.5 14.6 43% growth in commercialization revenue from royalty income on sales of TEMCELL® HS. Inj.1 Corporate transactions drive milestone revenues US$10.0 million of milestone revenue from licensee Tasly Pharmaceutical Group in first half FY2019 US$11.8 million of milestone revenue from licensee Takeda Pharmaceuticals in first half FY2018 TEMCELL® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd. Revenues – continued growth in royalties and substantial milestone revenues from corporate transactions |

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Profit and Loss for the six months ending (US$m) December 31, 2018 December 31, 2017 Total Revenue 13.5 14.6 Research and development (34.0) (31.6) Manufacturing (9.7) (1.7) Management & administration (10.7) (10.7) Contingent consideration (0.6) 8.7 Other operating income & expenses (1.0) 1.1 Finance costs (5.1) - (Loss)/Profit before tax (47.7) (19.6) Income tax benefit 3.6 26.2 (Loss)/Profit after tax (44.1) 6.7 Increase in loss primarily due to the following items in the current period: increased investment in commercial manufacturing by US$8.0 million in preparation for GVHD approval; incurred US$5.1 million of increased finance costs; And the following items in the comparative period: a one-off non-cash income tax benefit of US$23.0 million due to a revaluation of tax liabilities given changes in tax rates non-cash US$8.7 million gain on contingent consideration for reduction of future payments to third parties; Increased loss due to investment in manufacturing and financing, and non-cash gains in comparable period from revaluation of tax and contingent consideration |

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Operational highlights for the half year ended December 31, 2018

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IN DEVELOPMENT PLATFORM PRODUCT THERAPEUTIC AREA APPROVAL COMMERCIAL RIGHTS MSC (Bone Marrow) TEMCELL® HS Inj1 Acute Graft Versus Host Disease Japan MSC (Adipose) Alofisel®2 Perianal Fistula Global MARKETED Commercial and Late-Stage Product Pipeline Mesoblast receives royalty income from its licensee JCR Pharmaceuticals Co Ltd on sales of JCR’s TEMCELL® Hs. Inj. product in Japan Mesoblast will receive royalty income from its licensee Takeda Pharmaceuticals on Takeda’s worldwide sales of its product Alofisel® in the local treatment of perianal fistulae Study funded by the United States National Institutes of Health (NIH) and the Canadian Health Research Institute; conducted by the NIH-funded Cardiothoracic Surgical Trials Network Tasly's rights are limited to China; Tasly also has rights to develop MPC-25-IC for AMI This chart is figurative and does not purport to show individual trial progress within a clinical program PLATFORM PRODUCT CANDIDATE THERAPEUTIC AREA PRE-CLINICAL PHASE 2 PHASE 3 COMMERCIAL RIGHTS MSC Remestemcel-L Acute Graft Versus Host Disease MPC Revascor Advanced HF (Class II/III) End-Stage HF (Class III/IV)3 China4 MPC MPC-06-ID Chronic Low Back Pain MPC MPC-300-IV Rheumatoid Arthritis Diabetic Nephropathy Includes remestemcel-L (Crohn’s disease – biologic refractory), MPC-25-IC (Acute Cardiac Ischemia), MPC-25-Osteo (Spinal Fusion) and MPC-75-IA (Knee Osteoarthritis) TIER 1 TIER 2 1st allogeneic regen med approved in Japan 1st allogeneic regen med approved in Europe

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Minimal Treatment Options Market Opportunity Burden of Illness aGVHD is a life-threatening complication that occurs in ~50% of patients receiving allogeneic bone marrow transplants (BMT)1 Steroid-refractory aGVHD is associated with mortality rates as high as 95%1 and significant extended hospital stay costs2 There are no approved treatments for SR-aGVHD outside Japan In Japan, Mesoblast’s licensee has received the only product approval for SR-aGVHD in both children and adults >30,000 allogeneic BMTs performed globally (>20K US/EU) annually, ~20% pediatric3,4 Our licensee, JCR Pharmaceuticals Co., Ltd launched TEMCELL® HS Inj.5 in Japan for SR-aGVHD in 2016; reimbursed up to ~$USD195k6 SR-aGVHD represents USD > $700m USA/EU market opportunity4,7 Remestemcel-L: for SR Acute Graft Versus Host Disease (aGVHD) | 1. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology. 2. Anthem-HealthCore/Mesoblast claims analysis (2016). Data on file 3. Niederwieser D, Baldomero H, Szer J. (2016) Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. 4. Source: CIBMTR Current Uses and Outcomes of Hematopoietic Cell Transplantation 2017 Summary. Passweg JR, Baldomero, H (2016) Hematopoietic stem cell transplantation in Europe 2014: more than 40,000 transplants annually. 5. TEMCELL is the registered trademark of JCR Pharmaceuticals Co. Ltd. 6.Based on a ¥JPY = $USD 0.009375 spot exchange rate on market close on November 11, 2016. Amounts are rounded. Source: Bloomberg. 7. Data on file

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Remestemcel-L for SR Acute Graft Versus Host Disease: Commercial strategy overview TEMCELL® HS Inj. sales experience in Japan helps inform commercial strategy for the U.S. Fast Track designation provides eligibility for FDA priority review Commercialization strategy in place for product launch Building out efficient, targeted sales force FDA Biologics License Application submission on track for early 2019

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Source: Simon-Kucher & Partners 2017. Primary research 2017; Payers n=35, KOLs n=15, Cath lab managers n=4. Corlanor® (ivabradine) approved by FDA (April 2015). ENTRESTO® (sacubitril/valsartan) approved by FDA (July 2015). GlobalData-PharmaPoint Heart Failure (2016); McMurray et al., 2012;Yancy et al., 2013, 2016 ACC/AHAHFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. Early ACEI or ARB Statins Beta blockers Re-vascularization or valvular surgery Advanced End-Stage Pharmacological Add-on Diuretics for fluid retention Aldosterone antagonists Hydralazine / isosorbide dinitrate Digitalis New Oral Therapies for Class II-IV2 If ACEI / ARB tolerated, sacubitril/valsartan Progressive Vascular (Endothelial) Dysfunction and Heart Failure Class I Class IV Common Treatment Pathway in Progressive Heart Failure1 Revascor: Targeting patients with progressive heart failure despite maximal standard of care Mesoblast Target Market: Advanced and End-Stage HF patients3 Cardiac Resynchronization Therapy (CRT) Implantable Cardioverter-Defibrillator (ICD) LVAD Heart transplants Limited Therapeutic Options

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Market Opportunity Burden of Illness/Limited Options Unmet Need ~ 8 million patients with chronic heart failure by 2030 in USA alone1 17-45% globally die within 1 year of hospital admission1 Majority of advanced heart failure patients die within 5 years1 Despite recent advances in newly approved drugs, limited treatment options are available for patients with advanced heart failure2 New therapies to reduce hospitalizations and mortality in patients with advanced heart failure who have failed other therapies Greatest need is in NYHA class III/IV where event rate is highest US healthcare costs for NYHA class II-IV patients $115bn/year5 Hospitalizations account for ~69% of expenditure3-5 Multi-billion dollar annual market opportunity in USA4,5 | Heart Failure: Preventing disease and death worldwide – European Society of Cardiology 2014., 2. ACC/AHAHFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure., 3. Gurwitz JH, Magid DJ, Smith DH, et al. Contemporary Prevalence and Correlates of Incident Heart Failure with Preserved Ejection Fraction. The American Journal of Medicine. 2013;126(5):393-400. Derived by applying a HF-REF prevalence rate of 32.6% to the U.S. rate of 5.7m U.S. patients., 4.A Reevaluation of the Costs of Heart Failure and its Implications for Allocation of Health Resources in the United States. Voigt J. Clinl.Cardiol. 37, 5, 312-321 (2014)., 5.The Medical and Socioeconomic Burden of Heart Failure: A Comparative Delineation with Cancer. Dimitrios, F. International Journal of Cardiology (2015), doi: 10.1016/j.ijard.2015.10.172. Revascor: Commercial Opportunity for Advanced Heart Failure Market

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Revascor: Phase 3 Trial for Advanced Heart Failure Fully Enrolled Events-driven Phase 3 trial completes enrollment of 566 patients Evaluating a single dose of Revascor to reduce recurrent heart failure-related major adverse cardiac events such as heart failure-related hospitalizations and cardiac death Target patient population enriched for those likely to be both highest-risk for events and greatest responders to MPC therapy Trial will complete when sufficient primary endpoint events accrued, likely to be within 12 months from last patient dosed Trial design is 1:1 randomized, controlled, double blinded; conducted over 55 sites across North America |

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Market Opportunity Burden of Illness In the USA, there are approximately 250,000–300,000 patients annually who suffer from advanced systolic heart failure (NYHA Class III–IV). 1 Despite optimal medical therapy, mortality exceeds 50% in class IV patients.1 LVADs have improved survival, but morbidity remains high with patients on average experiencing greater than two hospitalization annually.2 Gastrointestinal (GI) bleeding is the leading cause of non-surgical hospitalizations in LVAD patients2 Device attributable major adverse events (DAEs) can cost on average from up to $46.5k per hospitalization2 Ongoing Unmet Need ~4,500 – 5,500 assist devices are implanted annually in the United States.3, 4 US LVAD market is growing double-digit CAGR and represents significant market growth opportunity3,4 US targeted commercial footprint provides low cost market entry Revascor: Commercial Opportunity for Use in End-Stage Heart Failure Patients with LVADs to Reduce Hospitalizations from GI Bleeding 1Gustafsson G, Rogers J. (2017) Left ventricular assist device therapy in advanced heart failure: patient selection and outcomes, 2 Mehra, MR Salerno C, Cleveland JC (2018) Health care resources use and cost implications in the MOMENTUM 3 long-term outcome study: a randomized controlled trial of a magnetically levitated cardiac pump in advanced heart failure, 3Agency for Healthcare Research and Quality – Healthcare Cost and Utilization Project – claims analysis using ICD-9 37.6 implantation of heart and circulatory assist systems, 4 Data on File

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MPCs Prolong Time-to-First Major GI Bleeding Event and Reduce Cumulative Major GI Bleeding Events in Two Confirmatory Randomized Controlled Trials in LVAD Patients1,2 MPC (n = 106) Control (n = 53) P-value Event Rate (100-Pt-Months) Event Rate (100-Pt-Months) 3.8 15.9 <0.001 MPC (n = 20) Control (n = 10) P-value Event Rate (100-Pt-Months) Event Rate (100-Pt-Months) 4.2 14.2 0.06 Rate of major GI bleeding events over 6 months in LVAD patients reduced by 70% and 76% with MPCs in two randomized controlled trials Mesoblast internal data post-hoc analysis 2017 (clinicaltrials.gov; identifier: NCT01442129). 2. Presented at American Heart Association Scientific Sessions 2018.

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MPCs Reduce Hospitalization Rate from GI Bleeding by 65% in 159-Patient Phase 2 Trial1 1 Presented at American Heart Association Scientific Sessions 2018.

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21st Century Cures Legislates an Expedited Approval Path for Regenerative Medicine Advanced Therapies (RMAT) Key benefits of the RMAT designation include: Potential eligibility for priority review and accelerated approval Potential to utilize surrogate endpoints for accelerated approval Potential to utilize patient registry data and other sources of “real world evidence” for post approval studies, subject to approval by the FDA Mesoblast received guidance from FDA that reduction in major GI bleeding is a clinically meaningful outcome could be used as an endpoint to support product approval Mesoblast plans to meet with FDA in 1H 2019 to discuss pathway to filing for Biologics License Application (BLA) Revascor (MPC-150-IM) Has Received RMAT Designation for Use In End-Stage Heart Failure Patients with LVADs

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Minimal Treatment Options Market Opportunity Burden of Illness Unmet Need MPC-06-ID for Chronic Low Back Pain due to Disc Degeneration Back pain causes more disability than any other condition1 Inflicts substantial direct and indirect costs on the healthcare system,1 including excessive use of opioids in this patient population2 Treatment options for patients with CLBP who fail conservative therapy include opioids and surgery 50% of opioid prescriptions are for chronic low back pain (CLBP)2 MPC-06-ID development focused on over ~3.2m patients with CLBP due to degenerative disc disease (DDD) in US alone3,4,5 USA market opportunity >USD $1 billion3,4,5.6 1. Williams, J., NG, Nawi, Pelzter, K. (2015) Risk factors and disability associated with low back pain in older adults in low-and middle-income countries. Results from the WHO Study on global ageing and adult health (SAGE). PloS One. 2015; 10(6): e0127880., 2. Decision Resources: Pain Management Study, Chronic Pain December 2013., 3. Decision Resources: Chronic Pain December 2015., 4. LEK & NCI opinion leader interviews, and secondary analysis., 5. Navigant: Commercial Assessment for a Proprietary Cell-Based Therapy for DDD in the U.S. and the EU3 – August 2014. 6. Data on File. Novel therapeutic approach for durable improvement in pain and function Potential alternative for opioid use or surgical intervention |

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Chronic Low Back Pain MPC-06-ID Post-Hoc Phase 2 results over 24 months provide target endpoints for Phase 3 trial | B: Phase 2: Treatment Success Responders1,2 at both 12 & 24 Months p = 0.050 Subjects with missing data are classified as non-responders. Treatment Success Responders have a 50% reduction in LBP as measured by VAS AND a 15 point improvement in function as measured by ODI at a) 12 months, and b) both 12 and 24 months and no intervention through 24 months. A: Phase 2: Treatment Success Responders1,2 at 12 Months p = 0.032 404 patient 2:1 randomized Phase 3 trial completed enrollment March 2017 All patients to complete 12 month assessment for safety and efficacy in H1 2019

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Key Milestones Remestemcel-L for Acute Graft Versus Host Disease Successfully met all efficacy and safety endpoints through six months Initiate BLA filing for marketing authorization following FDA meeting scheduled for April 2019 Build out efficient and targeted sales force for product launch Revascor for Advanced and End-Stage Heart Failure Phase 3 events-driven trial in advanced heart failure in North America completed 566 patient enrollment Primary endpoint events continue to accrue; likely to complete within 12 months Mesoblast’s partner Tasly plans to meet in H1 CY19 with the National Medical Products Administration of China to discuss the regulatory approval pathway for Revascor in China Mesoblast plans to meet with FDA in H1 CY19 to discuss pathway for approval of Revascor for reduction in GI bleeding in patients with LVADs MPC-06-ID for Chronic Low Back Pain Phase 3 trial completed enrollment (Q1 CY18) All 404 patients in Mesoblast’s Phase 3 trial in MPC-06-ID for chronic lower back pain will have completed their 12-month assessments for safety and efficacy in H1 CY19 Establish additional global and regional strategic and commercial licensing arrangements