Thank you for standing by, and welcome to the Mesoblast March 2016 Quarterly Results. All participants are in a listen-only mode. [Operator Instructions] I would now like to hand the conference over to [Audio Gap].

Good morning. Thank you, operator. Good morning and good evening everyone. I am joined today by our Chief Financial Officer, Paul Hodgkinson, who will take you through the financial details of the results for the third quarter and nine months ended March 31, 2016. I will then guide you through the rest of the presentation focusing on our operational highlights for the quarter and the strategic path to bring our key products to market. We will then be happy to take questions. I would like to draw your attention to the cautionary note regarding forward-looking statements in this presentation. I will now turn the call over to Paul to provide you with an overview of our financial results.

Thanks, Silviu. If I start on Slide 5, just to introduce this, we are reporting as stated previously in US dollars, and this is the highlights of the nine months ended 31st of March. So cash on hand was $100 million at the end of the period, and if we look at the outflows as we indicated in the guidance given in earlier quarters, we have achieved a reduction of 25% versus the higher spending earlier quarters, and I will share that in a bit more detail shortly. In terms of the profit and loss account, we improved the loss before income tax by 14% or $9 million versus the comparative period, and within that the main cash affecting items were a deliberate reduction in R&D of 19%, and a reduction in our management and administration by 21%. And we still look to manage our runway to achieve the key inflection points for the coming period. Turing to Slide 6, if we look at the profit and loss account, you can see that 14% improvement in profit to $9 million, and a relatively flat position in revenue. I guess of note within the revenue line is we did get our first royalty - we did recognize our first royalty income on TEMCELL, which was launched pretty late in the quarter on February 24, and if we then turn to the driver of the loss performance in terms of why that has improved over the comparative, again the R&D expenses, we have reduced our expenditure on Tier 2 and we have deliberately managed our labor costs, and being quite selective about rehiring and managing our labor performance. In terms of management and admin we saved another $4.6 million, again focusing on labor costs. We did benefit by some currency impacts, and we reduced expenditure on IT. Finally in line with our readiness for the MSC asset, we did ramp up our manufacturing commercialization continuing the production for MSC-100-IV. Those are the main movements pertaining to cash in the profit and loss accounts. There were a couple of other movements on contingent consideration, but they relate to future cash flows, not today’s cash. Turning now to Slide 7, looking at our cash in more detail, so as we said in the previous quarters, you can see in quarter one of this year and quarter four of last year we had higher operating cash outflow and we have managed to bring that down. So we have had two quarters, one at $19.8 million, one at $22 million and I expect the third quarter to continue at that level. So in terms of our overall performance, we can see that we will deliver this 25% in comparison to those two high quarters, and we should be able to manage our inflection points going forward for the next 12 to 15 months. That is all I wanted to cover on the financials and now I hand back for a review of operations to Silviu.

Thank you, Paul. If you go to Slide 9, this is an overview of our product candidates in the major markets with high unmet need, and I will focus primarily today on those that we call our Tier 1 products and progress. The operational highlights for the nine months ended are as follows. For our MPC-150-IM product candidate for advanced heart failure, the Phase 3 trial was significantly reduced in size from 1,165 patients to 600 subjects following a meeting between our partner Teva Pharmaceutical Industries and the FDA. The trial is recruiting well across North America and is expected to expand substantially into Europe in the second quarter of 2016. Importantly the trial’s data monitoring committee convened in April. After reviewing the clinical data, the DMC recommended that the study should continue according to its protocol. This is a very important milestone for the company. The second product MPC-6 ID for Chronic Low Back Pain the current 360 patient Phase 3 trial continues to expand across many US sites, and in line with the FDA written guidance, the trial now uses a composite primary endpoint with acceptable thresholds for pain and function and a follow-up period of 24 months and these amendments have been put into the protocol as per the FDA guidelines. MPC-300 IV for biologic refractory rheumatoid arthritis top line Phase 2 results were released last quarter from the first cohort of patients who previously have failed one or more biologic agents, and the data showed that a single infusion of the lower dose resulted in early and sustained clinical responses with no cell related adverse events. With respect to TEMCELL, Mesoblast’s licensee in Japan, JCR Pharma, launched the first Allogeneic Regenerative Medicine product in Japan earlier this year, and this was a full approval not a…

Thank you. [Operator Instructions] Your first question comes from Alethia Young with Credit Suisse. Please go ahead.

Hi guys. This is [Indiscernible] on for Alethia Young. Thanks for the question. Can you comment on how conversations are going in terms of partnering in the back program this year? Thank you a much

Thank you for the question. So it is very important that I think Mesoblast partnered this product with a strategic partner that has a distribution, sales and marketing capability in the back pain space so that we can leverage a sales force that already caters to the target patient population. It is also important in our discussions with certain strategic partners that we have clarity from the FDA around approvability of the product and the whole program in totality. And I think what I can say is that I have given you a sense today of written guidance from the FDA, how we have implemented the written guidance into our existing Phase 3 program such that we have a high degree of confidence that this program meets the FDA’s expectations of achieving - that it could achieve its primary endpoint will be an approvable program. That is very important in our discussions with strategic partners and look, you know, our discussions are very advanced, and I would hope that and expect that in the short-term we will be able to update the market on strategic partnership for our back pain product.

Prefect. Thank you.

Your next question comes from Kevin de Geeter with Ladenburg. One moment.

Good evening. Do you hear me Silviu?

Yes. Hi Kevin.

Terrific. I guess staying on back pain for a moment, how should we think about the - just from a powering standpoint the portion of patients that will have no interventions through 12 to 24 months, you know, how many will not sort of make the protocol analysis?

Look, I think you just need to look back at our Phase 2 data. The definition of treatment success in Phase 2 that I showed you on that slide was exactly the primary endpoint that is in the Phase 3. So in fact, through 24 months, 37% of the low dose treated patients versus 11.8% of the saline treated patients achieved a prespecified threshold of 50% back pain reduction, 15 point ODI improvement and no intervention at the treated level. That is how we have powered the study. So we have powered it for something like a 25% delta, and of course, expecting that something like a 15% to 20% dropout rate.

Terrific. That is very helpful and back to Graft-versus-host disease in the US, Phase 3 pediatric program, you know, when should we think of a timeline for last patient enrolled, just a general update of how enrollment is going in that study?

Yes, I think there are two ways to look at that. The trial is enrolling to its natural completion. We hope to be able to complete it over the next 12 months, or sooner, but I think the point there is we continue to expand the number of sites. This is an active expansion process to more and more sites as they come on board. But in addition to that we have an active dialogue with the FDA and an upcoming meeting that we will talk about potential early interims, and an early stop based on efficacy that is beyond the minimum expectation. So I think this is an ongoing review of the program that may complete sooner rather than later, but it really depends on upcoming decisions with the FDA.

One last one if I may, and then I will get back into queue, can you just comment on any learning from TEMCELL’s launch in Japan, the potential applicability particularly to the US market, based on your exposure to that sort of commercial experience and then just your general thoughts at the moment whether or not with regard to the US market you would anticipate Mesoblast commercializing at least for your pediatric Graft-versus-host, or do you think a partner may add value?

Okay. So, I think it is too early to ascribe any learnings from the Japan launch to the US. I have to say we have got to have at least two quarters of information before we can say anything. But with respect to the US, absolutely our plan is to launch the pediatric product ourselves. I think there is no doubt that the US launch will benefit from the history of the Expanded Access program, which has been a huge program, which has encompassed more than 50 sites. And I think that will speak to the ease of the launch in the US if we are fortunate enough to have product regulatory approval. So we don't believe there needs to be a very large preparative state for the US launch, and we don't believe that for pediatric alone there will need to be a lot of people on the ground because maybe 50% of all the pediatric transplants performed in a handful of sites. So, in addition to that there is a possibility obviously of a pediatric voucher associated with product approval, and I think that is obviously dependent on legislation being renewed this year. But we are very optimistic that should we get approval a pediatric voucher could be linked to this product and that is why it is very important for us to take this to launch on our own. I think with respect to the adult GVHD program and other applications of the MSC technology, obviously we would be open and continue to talk to multiple partners.

Okay, I’ll get back to the queue.

Your next question comes from Jason Kolbert with Maxim.

Thank you Silviu and congratulations on the progress. But I am sorry, I dying to ask you this question. Where are we with Celgene are they - we were looking for a go or no go decision, can you give me an update there?

I don’t think anybody was looking for go or no go decision, that’s not the way I would ever have characterized that it all. And in fact, Celgene continues to be an important strategic investor of Mesoblast. We’ve had ongoing discussions that are far broader than the original indications covered in the Right of First Refusal and we continue to be an active dialogue with Celgene as well as with many other, rather may be a substantial number of other pharma companies who are in the inflammatory and immune mediated space and I think the results.

And so, we hope you understand why you are thinking I am characterizing it, giving Celgene coverage time limit associated with the agreement when the time limit passed you announced that the agreement was being extended. So I am little bit confused why you think that question is kind of better line?

I am not sure what the question is, could you repeat the question? They had a Right of First Refusal indications, yes.

In the original agreement you announced that there was a time line associated with that when that time line was passed you announced that the time line was being extended, so I am confused now as to whether there is a time line or whether that first Right of First Refusal you know, ever expires wasn’t there a time associated with that?

Of course, so they had a Right of First Refusal of certain asset notably GVHD and chronic disease. And that Right of First Refusal has expired, we continue to be in dialogue with Celgene as we are with the number of other companies that have an interest in potentially commercializing inflammatory bowel diseases assets as well as the number of other inflammatory conditions such as rheumatoid arthritis. And of course the rheumatoid arthritis asset which was never passed of the Right of First Refusal with Celgene is a major driver of the way we see our inflammatory portfolio. Our first interim analysis of the RA data was at a top level presented last quarter, the full data set will be presented around end of June where we will have a full read on both cohorts and both doses and that represents probably the lead value inflection for an inflammatory discussions with a number of pharma companies.

Silviu, thank you so much for clearing that all.

Your next question comes from [indiscernible]

Hi, thank you. With respect to the Phase 3 Chronic Low Back Pain trial, I think previously you talked about and interim analysis that may be consistent with respect to CHF once that interim work is done whether also due the case that you don’t scroll what the result is?

Yes, I think a very important question. As I mentioned earlier, we plan to have multiple interim looks in this trial and the early look has to be in line with our strategic partners views. And so I think rather than be prescript it at this point I think it’s important to note that several of our partners have strong views on how to handle an early interim and what the objectives are. Most importantly I think is to use the 12-month interim as a potential resizing event for a parallel second trial that will need to be done so the two trials in conjunction complete at the same time so we have product registration and product approval. And I think some of these discussion points are very much linked to the initiatives and the plans to potential strategic partners in respect.

Okay and then just shifting back over to the CHF Study you talked about providing some further guidance on time line this quarter, can you give more specific about what you might be able to say, like you might be haven’t followed?

Sure, I think the important point is this exit Phase 3 trials are trading very low, we - based on the recruitment rights across the US, based on initiation of multiple sites in pretty short order in Europe, based on additional strategic initiatives, we together with our partner should be able to update on time of completion of this trial, which is obviously much shorter than we have previously talked about, when it was 1,100 patients, time of initiation and completion of a confirmatory study and whether or not we can sequence other in parallel and sequence depending on the FDA’s views of how sick these patients are and what's needed for product approval.

Okay great. We’ll look forward to that.

Your next question comes from Anupam Rama with JPMorgan.

Hi, good morning guys. This is Anupam Rama. Thanks for taking the question. Just a question on CHF, so we are today understanding correctly that we have must be reviewing its participation in the program in this quarter I just wonder if you can help us understand what can might determine their ongoing involvement and if there is not to go forward. How you might be thinking of strategic alternatives for the program?

Look [indiscernible] has been able to review its participation from the very beginning, contractually has the ability to review again at this point in the quarter, but really you need to address this question to Teva not to me, I mean I'm sure that they take their review based on many components including efficacy safety data including strategic objectives, including how well the trial is progressing including the views of the data monitoring committee, the principal investigators and the like. I think, there were many components, but I think Teva had the ability at previous times to continue to look and review you know, it’s not that I'm not going to pre-empt and I think at this point in time Teva is a sponsor continues to interact with the FDA has done a terrific job operationally and I have no reason to believe that he will change.

Got it and just as patient number note in the DMC review, should this be 125 patients is it somewhat reflexive works things currently stand in terms of patient enrolment in a trial. And has that like change in the pace of enrolment?

Now the short answer is no. The DMC reviewed the first 175 patients. We are way beyond that, we will be approaching the 250 patient mark and beyond. So I think what you are seeing now is there is a hockey stick effect where patient recruitment is substantially going to pick up as we move into Europe. And clinical trials give you the expected completion date for this trial, so it’s publically available. And that’s our recruitment target with 600 patients.

Great, thanks for taking the questions.

Thank you.

Your next question comes from [indiscernible].

Hey guys, can you hear me.

Yes.

I shouldn’t have been given my middle name, its bit embarassing. Of course, all right. Listen just quickly one thing can you just clarify the difference between royalties and revenues from Kenzo out of Japan are we talking revenues from sales or royalties as an sort of milestone payment?

Yes, Mike. Yes, as we have disclosed in the perspectives where we get a royalty in the 20s from the sales and net sales of JCR into the market. Does that clarify for you?

Okay, that was helpful. Plus this last question, so you’ve got a number programs that could potentially be partnered and the one that’s obviously received the most attention is back pain you also mentioned GVHD, but are there any other programs out there that you actively engaging potential partners with [indiscernible] for?

Well the key programs are rheumatoid arthritis and chronic disease, those are the two programs that we have substantial data set and represent major unmet needs particular in the biological refractory population there the intense with chronic disease is early remission and with rheumatoid arthritis certainly an ACR response remission. So those are two very important areas that we’re in substantial discussions with various parties.

Okay, thank you that’s all from me.

Your next question comes from Tanushree Jain, Bell Potter Securities.

Hi Silviu and Paul thanks for taking my questions. I just wanted to understand Silviu the conditional approval part in Japan has been in place for a while and we’ve seen on obvious highlighting of that in your presentation today. Should we read that as a near term focus of Mesoblast in using that path way to get some of their late stage products in Japan and if that’s the case could you clarify what products could be up for initial launch there?

Sure. So, we’ve gained a fair bit of experience in dealing with the PMDA through this new regulatory pathway, and obviously in the JCR in the approval process and the reimbursement process. Each of our product candidates that has generated signals in phase 2 in the US, heart failure, diabetic nephropathy, rheumatoid arthritis and chronic disease each of those programs is appropriate for accelerated approval in Japan on the basis of conditional approvals. And we’ve put a lot of thought into this and I think rather than pursuing individual products with individuals partners the likely approach in Japan is to establish a multi-product partnership, a strategic collaboration with either a large pharma company of a conglomerate so that we have effectively a stable of products that can be channeled through a parallel process for conditional approvals and launch with appropriate support for phase 3 for these assets which could come either in standalone programs in Japan or could be part of global phase 3 programs that are ongoing.

Right. And do you have more visibility now on what the size of bridging trial might look like in Japan?

Well, you only need to look at some of the products that are recently being approved in Japan. At the same time as [indiscernible] for example, an [indiscernible] muscle based therapy for class 4 heart failure patients was approved on the basis of seven patients and that product was reimbursed quite substantially for that type of population. We believe that we’ve got a more effective product with greater safety, with greater phase 2 data that would be potentially appropriate for not just class 4 but also class 3 patients. And so, I think Japan for a heart failure program is an obvious entry point. But I think the message is that small phase 2 data sets may be sufficient for indications where there substantial unmet needs and where there mortality risks.

Your next question comes from Chris Kallos with Morningstar.

Good morning Silviu. Maybe I’m repeating this question, but just back on the CHS trial, can you just clarify why the disclosure of interim trail results and also when should we expect something out of that trail in terms of clinical data?

The FDA has been very clear with us, it’s a standard view of the FDA, but the provider ask with specific written guidance that we should not be providing specific data based on either [indiscernible] or the primary end point to the market because potentially that can impact the integrity of the trail and can bias both patients and investigators to how well the trial is travelling. So, we’ve got to be very mindful of what the FDA says because if we don’t do what the FDA says the risk is that they will accept this trail for registration purposes. So this is a real and important issue. Having said that you can take note of the data monitoring committee that has reviewed clinical data from the first 175 patients and they’ve been very clear that the trial should proceed as planned and I don’t take those kind of statements lightly.

So, is this a new development?

Yes.

Okay. And just broadly speaking given the rate of uptake and the right of recruitment can we speculate on what might be a reasonable timeframe to get a result?

The clinicaltrials.gov website talks about this trial completing on August 18.

So any time between now and then?

We’ve a second interim announces in-built based on futility and we’ve previously announced that will be done when 50% of the events have occurred. And we’ve previously announced that in discussions with FDA that will have an in-built early stop potentially based on overwhelming efficacy. So if we see that we’ve substantially reduced heart failure events, hospitalizations or death, there is a possibility for earlier completion based on positive outcomes.

Great, thanks for that very helpful.

Your next question comes from Craig Collie with Macquarie Research.

Hi guys, thanks for taking my questions. I just have a couple of quick ones. First of all, Paul in the slide, you received royalties of [Timsel] but I couldn’t see anything in the 4C, can you point in the direction where I can see that number?

Yes, the royalty there are in our revenue line Craig.

Cash?

No, no because as you depreciate with many of these contracts cash is receipted in subsequent period. So let’s not forget they only launched on February 24, book sales they have a contractual period to calculate the royalty and then they have an agreed contractual period to pay it over. So no, we’ve not got the cash from the multi, we expect that in future quarters.

Okay, thanks. And second, any commentary as to what might happen to cash consumption if [indiscernible] review on its involvement turns out to be unfavorable?

I don’t think it’s for us to speculate anything like that we don’t see any evidence of that and this is not an issue that we would be working through at this point in time. At this point, Teva is a sponsor of the trial, funding the trial and things are going better than we could have anticipated.

Okay. So no consents about potential cash burn increasing if they pull out?

This is not an issue that we’re reviewing at this point in time at all.

Okay, thank you.

Your next question comes from [indiscernible]

Thanks for taking my question. Referring back to the CHF interim trial understanding that they’ll be looking at responses in admissions like may be systolic and diastolic volumes, can I just double check did the DMC look at those and if they did examine those, who has been told that information to yourselves and Teva have information about those, getting points at the time of the interim analysis?

The monitoring committee certainly had access to the systolic volumes, diastolic volumes and the like they review all clinical data available to them. Neither Mesoblast nor Teva have received specific outcome of the interim analysis. What we’ve received at this point is a recommendation of the DMC to continue the trial as planned.

And my second question is, can you give a timeline of when you expect to be able to give an update on the future timing for the trial?

Yes. We expect to provide detailed updates on timelines during Q2.

Thank you, that’s all from me.

Your next question comes from Chris Kallos with Morningstar.

Sorry I had a follow up question. Just in broad terms how would you characterize market at the moment in the absence of getting a partnering deal, you had to come back to the market to raise money?

We’re looking for non dilutive capital from strategic partnerships and we expect that we’ll be able to update the market in the short term about that.

Okay, great thanks.

There are no further questions at this time, I’ll now hand back to Mr. Itescu for closing remarks.

Great, thank you everybody, your continuing interest in Mesoblast and ongoing support is appreciated. Thank you for your time today.

That does conclude our conference, thank you for participating, you may now disconnect.