Hello, and welcome to Mesoblast Financial Update and Operational Highlights Webcast for the Three Months Ended September 30, 2018. An announcement and slide presentation has been lodged with the ASX. These materials will also be available on the Investor page at www.mesoblast.com. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. Before we begin, let me remind you that during today's conference call, the company will be making forward-looking statements that represent the company's intentions, expectations or beliefs concerning future events. These forward-looking statements are qualified by important factors set forth in today's announcement and the company's filings with the SEC, which could cause actual results to differ materially from those and such forward-looking statements. In addition, any forward-looking statements represent the company's view only as of the date of this webcast and should not be relied upon and representing the company's views of any subsequent date. The company specifically disclaims any obligations to update such statements. With that, I would now like to hand the call over to Dr. Silviu Itescu, Chief Executive of Mesoblast's. Please go ahead.

Thank you very much. Good morning and good afternoon to the operational highlights and financial results for the quarter ended September 30, 2018. If we could move straight to slide four please. Mesoblast has a disruptive technology platform, which is based on immuno-selected cellular medicines that are well characterized with respect to both the cells and the mechanisms of action. They have an extensive and robust IP estate, and we target refectory disease types. We've got industrialized, scalable manufacturing processes that allowed us to develop off the shelf delineated products, with batch-to-batch consistency and reproducibility. And we are very mature now with multiple revenue generating products and Phase 3 assets that I'll be telling you more about. On slide five, I think, the importance of understanding that the immuno-selected STRO-1, STRO-3 mesenchymal precursor cells represents the earliest precursor in the mesenchymal lineage and gives us the ability to work with homogeneous populations of cells that have got well characterized receptors, surface phenotypes and mechanism of action. Importantly, to understanding the mechanism of action is that the receptors on the surface respond to a number of prime [ph] inflammatory cytokines that are president disease tissues, resulting in the cells being activated and releasing variety of biomolecules responsible for immunomodulation and tissue repair. So inflammation is core to the mechanism of action of that cells. Slide six, speaks to the commercial translation capabilities our technologies positioned for scalable and industrialized manufacturing. We're able to produce the anticipated commercial quantities of cells necessary to achieve the numbers of products for patients in large volume diseases such as a heart failure and we have proprietary methods for scalability including media formulations and bioreactor technologies. As I mentioned earlier, on slide seven, our global IP estate provides substantial competitive advantages. It covers compositions of matter,…

Thanks, Silviu. Turning now to the financial slides, we're pleased to report a substantial increase in revenue and a strong cash position. Starting with revenue, as shown on slide 11, total revenue for our first quarter for our fiscal year 2019 was $11.6 million, a $10 million increase over the first quarter in the prior year. Revenue included royalties from JCR Pharmaceuticals on sales of TEMCELL for GVHT in Japan. We recorded $1 million of such royalties, up 66% from the prior year's Q1 period. We also recognized milestone payments during the period, specifically we recognized $10 million of milestone revenue from our strategic cardiovascular partnership with Tasly for China. Finally, we received a $0.5 million milestone payment from JCR based on TEMCELL achieving a certain amount of cumulative sales. JCR's ability to continue to grow TEMCELL should bode well for the commercial potential of our late-stage GVHD product. Turning to slide 12, we can look at the remainder of the income statement. While our loss after tax is larger than the amount we reported in Q1 2018. One of the primary drivers of this increase relates to a non-cash difference in the remeasurement of our contingent consideration between the two quarters. In earlier period, we remeasured this contingent consideration creating a non-cash benefit to Mesoblast. There is no such meaningful change in remeasurement in the recent quarters. For further details please refer to our current financial statements found in our Form 6-K filings. Also during the quarter operating expenses increased, including R&D as we continue to make progress in our late-stage clinical trials. Manufacturing due to pre-commercial activities related to our GVHD product. And finally we recorded finance costs during the quarter related to our interest expense on our credit facilities. Slide 13 shows our cash flows for the quarter. Our cash used in the quarter was largely similar to the cash used in Q1 of the prior year. Our cash position is shown on slide 14. We completed the quarter with just over $55 million of cash. Since the end of the quarter, we received $40 million from Tasly, $20 million as an upfront technology access fee, and $20 million as an equity investment. When taken together our pro forma cash position as of September 30, 2018 is $95 million. In addition to this cash an additional $50 million may be available under our existing arrangements with Hercules and NovaQuest. To sum up, we're proud of the quarter's financial performance and the steps we've taken to strengthen the balance sheet to achieve our upcoming milestones. I'd like to hand the presentation back to Silviu now.

Thank you, Josh. I’d like to turn now to operations turn. And if you could turn to slide 17 please. The market opportunity for acute graft versus host disease. This is a life threatening complication that occurs in about 50% of patients receiving an allogeneic bone marrow transplant. Mortality rates in those who do not respond to steroids can be as high as 95%. And there are no approved treatments for steroid-refractory graft versus host disease outside of Japan where our licensee has been very successful in penetrating the addressable market. There are about 30,000 allogeneic bone marrow transplants performed globally, of which about 20% are in children. And we have learned much from the success of our licenses access to Japanese market where the product TEMCELL is reimbursed for up to $195,000 per patient. On that basis we believe that the market opportunity in the U.S. and EU is substantial for our products candidate. So what is the operational update for this product on slide 18. The Phase 3 trial evaluated remestemcel-L in 55 children to improve overall response rate and survival. 89% of the children had the most severe form of the disease grade C/D disease, typically associated with mortality of up to 95%. The study successfully met the primary endpoint of improved overall response highly significance, demonstrated day 100 overall survival of 75% with 87% survival in those who are early responders and that response rate was maintained at 79% through day 180. The remestemcel-L infusions were well tolerated. These findings were very consistent with previous results in 241 steward refractory children with the disease under an expanded access program who also had failed to respond to multiple biologic agents. Remember that in this trial biologic agents were not co-administered. Slide 19, identifies the pathway to market…

Thank you. [Operator Instructions] Your first question comes from Mark Breidenbach with Oppenheimer.

Hey, good morning and thanks for taking the questions. Just two quick ones for me, with regard to enrollment in the Phase 3 heart failure trial, it sounds like we're getting really close to completion of enrollment. Is it too early to project when top-line data will be available from the study?

Remember, it's an events driven trial. So there is a minimum number of events that the FDA requires the trial to achieve. It's not so much the total number of patients it's how many events occur and of course it has a therapeutic benefit and those events rates will be somewhat slower than would be seen normally. We need to review the total number of events and be able to update the market in due course, but we’re certainly very close to achieving the pre-specified minimum number of patients.

Okay. And with regard to product registration in Class IV heart failure, let’s assume that the FDA goes along with an accelerated approval pathway with GI bleeds as a surrogate endpoint. What do you imagine they would ask for as a confirmatory trial following an initial approval?

Yes, Mark, first of all GI bleeding and hospitalization is not a surrogate endpoint. It is a key clinically meaningful endpoint that the FDA has identified as very important and a major unmet need in these patients. So the real question is whether we have sufficient data in two trials that have been confirmatory of each other. One with a post talk analysis the 30 patient study. And one with a pre-specified analysis in 159 patients. We'll be sitting down with the FDA and have exactly that discussion with a full dataset in front of us. I think the key elements here are that it is a major unmet need it's probably the number one cause of morbidity in this patient population. The patient population per se is an orphan one. And so it is not easy to reproduce these large trials in such an orphan population. And the results have been very confirmatory and very similar in nature. And so I think that will be the argument. The question then will become what kind of -- if we're fortunate enough to have a positive outcome from the discussion with the FDA, what kind of post-marketing obligations would we have. It could very well be another confirmatory study or it could a registry study. And those are all options under the RMAT designation.

Okay, got it. Thanks for taking the questions.

Your next question comes from Jeffrey Cohen with Ladenburg Thalmann.

Hi, Silviu and Josh. Thanks for taking the questions. Just a couple if I may. So first off, Josh, could you clarify the $10 million recognized this quarter from Tasly. So the total was $20 million in the form of cash plus $20 million in the form of equity. Could you clarify the price and time with the equity and also was the $10 million representative of the first half of the cash portion?

Sure. So the $10 million is representative of a portion of that upfront milestone payment, the rest will be recognized over time. And the $20 million of equity that came in, I believe that prices $1.86. We have had it in the deck, but we pulled it out of the deck just to try to simplify things. I’m pretty sure it’s $1.86.

Okay. And the additional shares were represented in this quarter?

We can provide the share count immediately after the call. I believe it’s in the 6-K that’s filed as well.

Okay, got it. And Silviu, can we talk a little bit about lower back pain, so the MPC trial. So could you talk about just hypothesize with us as far as in actual practice for our degenerative disc disease. How do you pursue this reading out as far as real world and treatment paradigms prior to or after or in combo with artificial disc?

Sure, thanks for asking that question. The target patient population is very different from patients who require an artificial disc. We are at the other end of this extreme. So entry criteria into this Phase 3 trial required patients to have severe pain, have failed conservative therapy including steroid injection, but have no more than 30% loss in described by X-ray. Now as you know, an artificial disc requires much more severe structural loss. So, an artificial disc with Spinal Fusion for example are offered at the other extreme, the end-stage. We’re positioning this product in the much earlier framework. And in fact, we would like to see this product used before anybody offers opioids to patients. That’s where I think it’s going to fit. And if you look at our Phase 2 data, as many as 50% of patients who get a single injection into the intervertebral disc have no pain for up to two years. That kind of durability in pain is -- really has never been seen with any other kind of treatment. When we’re talking about the effects of opioids or non-steroidal drugs, they are reported in terms of three to four months of follow up at best and the levels of improvement in pain are fairly modest. Certainly nowhere near the levels of pain improvement that we see with a single injection of ourselves. So if we’re successful in this Phase 3 program, we have the chance to position in the patient journey relatively early, ahead of opioids and well ahead of any artificial devices or other such technologies.

Okay. Is there some imaging being done along with trial that may give some clues or suggestions as far as if the disc is actually being regenerative over time throughout the 24 month period?

Yes. So we’re certainly getting MRIs and X-rays. In the Phase 2 trial we saw evidence that over a three year period there was a stabilization if you will or less of a decline in X-ray disc height loss in the cell treated than the cell in controls. We hope to see the same pattern in this Phase 3 program. I would say that as you know, MRI is not a validated technology here. We probably go one of the largest databases of the natural history over a three year period of what the discs look like in these patients. And remember that that these patients have relatively early degeneration. What I can tell you is that in control patients over a three year period MRIs don't seem to change much. So whether we see a substantial difference by MRI I don't know, but X-ray disc height is certainly something that I hope to see a difference in. In addition to that, I think, what is notable is a severe degree of pain despite the relatively moderate degree of structural disease, which goes to the heart of the mechanism of action. Why does such patients have such severe pain. Most likely because they have severe inflammation in the middle of their disc. The inflammatory process in the disc activates nerves, activates blood vessels and that results in acceleration and prolongation of the severity of pain. And while we have seen in phase two over three years is quite a dramatic and durable reduction in pain. Even with that the terrible structural deformity that didn't exist in these patient in the first place. So fundamental to where I think the cells are working is by switching off severe inflammation and having an effect on the effect of pain for a prolonged period.

Okay, perfect. Thanks, Silviu, I appreciate it.

Thank you.

Your next question comes from Tanushree Jain with Bell securities.

Hi, Silviu and Josh thanks for taking my questions. Josh a quick one for you first, you were supposed to receive EUR 5 million payment from Takeda, is that still slated for this half?

It’s expected in December.

In December. Great. And so just on GVHD, could you talk a little bit about the label expansion with the adult subset who are lever and got fit and what's the plan there. What are the timelines then, what do you expect would be the natural course to develop the product for that?

Yes, so obviously the definitive trial design requires agreement with the FDA. And those are part of the discussions that we'll be having this month and next month as part of the overall pediatric approval process. But you are quite right, we plan to be targeting the high risk adult population meaning steroid refractory with predominantly liver and gut disease. One thought process is an open label registry study.

Yes, thank you.

[Operator instructions] Your next question comes from Jason McCarthy with Maxim Group.

Hey guys, Michael Okunewitch on for Jason, thanks for taking my question. So I figured some discussion of MPC-06 to be topical considering the 2018 FDA meeting on analgesic drugs is occurring today. In the briefing documents they actually focused on opioid sparing and replacing analgesics. But one of the key concerns was under management of pain as a result. So what I was wondering could MPC-06 potentially enable the use of these less effective opioid sparing painkillers, while managing pain to the same or even greater degree? And then do you think considering that regulators may take a more positive view especially when lower back pain is responsible for so many opioid prescription.

Thanks for that question. And I think I totally agree with you. The kind of pain management that we're seeing with a single injection of our cells is quite -- is very impressive actually. And I think that the question is where these treatment will be positioned overall in the armamentarium. Obviously opioid sparing agents of the non-steroidal class or other novel classes would be cheaper and would be used earlier. I think that we would see our cells as being used initially in those who failed those kind of more conservative approaches. And then you'd have our cells as the next in line as an opioid sparing agent with potency. And I think there are additional agents that approved already as opioid sparing agents than I could imagine combinations of those together with our cells to really enable complete avoidance of opioids.

Thank you. And then just do you think you could give us an update as trial and help us understand the timelines considering that next March all the patients who have been enrolled for 12 months?

Yes, absolutely. We are having ongoing dialogue with the FDA around precisely this, how much data, how long a follow up do we need, particularly given the new environment with the opioid crisis. And, I think, I have to be frank this is an evolving discussion. And I'd like to sort of leave at that, we will update the market when we have further clarity from the FDA.

All right, thank you very much.

That brings us to the end of today's call. I'll now hand back to Dr. Itescu for closing remarks.

I’d like to thank everybody for being on this call. And we thank you all.

That does conclude our conference for today. Thank you for participating. You may now disconnect.