I've scanned through the script very quickly, and just want to...

I've scanned through the script very quickly, and just want to share a few thing which seems worth:

[00:19:18] As of today's date, we have enrolled eight vitiligo patients, with six of those patients being enrolled in the pivotal study and one site and two patients enrolled in the Single-Site did a legal feasibility study at UMass. We have seen a remarkable level of interest in our vitiligo study from physicians, sites and patients, and we have a strong pipeline of sites looking to participate in this trial. For this reason, we believe that vitiligo is likely to be our fastest enrolling study and therefore our next approved indication for the results system system. We are seeing some very strong tailwinds in the broader vitiligo market, which we believe bode well for resell and the huge unmet need specifically. There are four point five million Americans suffering from vitiligo, deep pigmentation, with no FDA approved products presently available to provide pigmentation for these patients. In addition, we expect to see an increasing number of stable vitiligo patients available for resell treatment, courtesy of Insight's new therapeutic topical ruxolitinib. Additionally, Sigma's recent determination of medical necessity and correspondingly strong reimbursement support of thirty eight thousand dollars over a 12 month period points to positive coverage trends for patients requiring vitiligo treatment. These are very strong signals for the resell system as we seek to be the first curative therapy for pigmentation of stable vitiligo patients. Outside of our commercial growth and clinical studies with the results system, we have also seen good progress elsewhere in our business, together with our commercial partner, cosmetic.


[00:21:25] We continue to focus on regulatory approval in Japan. I am pleased to confirm that we have completed the three required nonclinical benchtop studies in August as scheduled. Our efforts and interaction with cosmetic and the Japanese regulatory authority are ongoing and we are hopeful of advancing our application for marketing approval of the Reef Health System under Japan's Pharmaceuticals and Medical Devices Act, or PM the. In terms of reimbursement, the company remains on track with its transitional pass through payment application known as Tippity, which will support separate additional Medicare payment for the resell system, specifically in the outpatient setting. The Centers for Medicine and Medicaid Services, or CMS, is expected to make its final decision in December with a C code to be implemented with effect on January 1st. Twenty twenty one, assuming no delays due to covid. Looking ahead, we're hopeful that the inherent benefits of the resell system to patients and hospitals will continue to resonate and that we will see increasing and diversified use of the resell system in both our existing customer base and with new customers. Likewise, we are focusing on progressing our pivotal studies. And I've become very bullish on the Vitol legal market opportunity, which we think is in excess of seven hundred and fifty million dollars. With that, I'll turn it over to Sean for details on our financial performance in the quarter Sean.

00:23:18] Thank you, Mike, for the first quarter ended September 30th. We reported revenues of five point one million compared to three point three million and the corresponding period last year and three point nine million in the June quarter of 2020. Revenues for the first quarter include sales, the retail system in the United States, five million, an increase of one point two million or thirty one percent over the thirty point eight million reported for the June quarter. The gross profit for the September quarter was four point one million, representing a gross margin of 52 percent. This is an increase of one point five million from the gross profit of two point six million of gross margin, eighty one percent reported in September 2013. The total operating expenses for the September quarter were fourteen point nine million, which is an increase of six point six million compared to the same period in nineteen. The increase in operating expenses was driven primarily by increases in personnel costs, clinical study costs, associated care for clinical studies, and the costs associated with establishing EBITDA as a US public company, including completion of our regional affiliation, the first U.S. staff audit for the three year period.

[00:26:44] So thank you, Josh, for your question, yes, there is a degree of seasonality that usually hits the October month, November and December are generally picking up to be normal relative to what we generally see. And and so far as sequential quarter over quarter growth, we do anticipate that will continue to grow our business and not have a flat quarter as we had in the quarter before last. Does that answer your question appropriately?

Lyanne Harrison[00:51:11] I can't thank you. And if I could just have one follow up, and this is probably a question for Sean, if I think about your cost structure, obviously this quarter it was a fairly high cost structure. You mentioned that there were a few items in there as a result of redundant stylization, et cetera. Sean, I'm able to highlight what do you think in this quarter's OpEx might be nonrecurring if we think about the remainder of financial year?Sean Ekins[00:51:40] Twenty one, yeah. Thanks for your question. As you noted in our OpEx, we did have in the current quarter a lot of one off costs and is really related to freedom in the company from Australia to the US, along with having our first audit, which was for a three year period. We also had our first proxy statements and our first registration for a shelf. A lot of that will be non-recurring. That I answer your question there.Lyanne Harrison[00:52:12] Yeah, I'm just trying to understand the quantum stuff, I think about the general that admin expenses of five point five million, what proportion of that do you think might not recur in subsequent quarters?Sean Ekins[00:52:26] Right. My anticipation moving forward that Gené will come down. I think it does come down more in the range of four to four and a half million dollars. Like I mentioned, the amount of cost that we did have in there for two one was rather significant. But again, that was the charges incurred for selling the company the first US cap, which we won't have that going for. We will have the cost. We're having an audit, but it will be a three year period, which is quite substantial.Lyanne Harrison[00:52:55] Ok, so you're thinking it sort of going a four and a half million, and then if I look at research and development, obviously the cost looks like it doubled compared to the last period. Should we expect that to the three million per quarter going forward, given that all the pivotal trials that are currently in place?Sean Ekins[00:53:13] Yeah, yeah. And if you hit it right on the head, I mean, in the sense that our R&D did jump up in the current quarter and this is just like you mentioned, it relates to our pivotal trials that we are undergoing my thought process moving forward that I think would be in the range of three to four million dollars. But this will be in line with the expansion of our fiscal studies.