Q3 2023 MannKind Corp Earnings Call
Okay.
Yeah.
Good afternoon, and welcome to the Mannkind Corporation 2023 third quarter financial results earnings call.
As a reminder, this call is being recorded on November seven 2023, and will be available for playback on the Mannkind Corporation website. Shortly after the conclusion of this call until November 21st 2023.
This call will contain forward looking statements such forward looking statements are subject to risks and uncertainty, which could cause actual results to differ materially from these stated expectations.
For further information on the company's risk factors. Please see their 10-Q report filed with the Securities and Exchange Commission. This afternoon, the earnings release and the slides prepared for this presentation.
Joining us today from Mannkind are Chief Executive Officer, Michael Gastonia, and Chief Financial Officer, Steven Binder, I would now like to turn the conference over to Mr. Gastonia. Please go ahead Sir.
Thank you T D.
Thank you all for joining us today, it's been six years since Stephen I became CEO and CFO. We've turned this company from losing well over $100 million a year into our first profitable quarter in our history.
We've helped over 20000 people on our Mannkind manufactured product last quarter, and our pipeline is moving faster than ever to help more as we continue to live our mission to help patients live a better life.
How do you think about our highlights this quarter, we made great progress on the clinical and financial aspects of our company.
And the orphan lung space, we've seen debates of royalty revenue of over $20 million and manufacturing of $13 million.
On the pipeline Mannkind 101 cannot be in a better position.
We came from our last earnings call. When we just had learned of a fire in our facility and our partnership in Germany to successfully moving CMC here in Danbury, we have manufactured our first clinical batch in record time.
Mannkind 201, our inhaled <unk> program has continued to progress towards filing an R&D and starting our phase one trial in the first half of 'twenty four.
Feedback from our quality years has been very positive on this program and we're excited to get this in humans as quickly as possible.
On the endocrine business, we've achieved our first quarterly positive contribution. This is one quarter ahead of our expected Q4 goal.
Half a million dollars in Q3 of this year.
And that was driven by our friends at 24% growth year over year.
As we think about <unk> and then health rate, we're super excited on the clinical progress. These two trials have made.
They are pivotal for our future in the diabetes business.
An inhaled one we achieved our pre specified interim analysis, which was run when we hit 50% enrollment to determine the size of the trial is appropriate or not we now expect to finish up enrollment and continue to progress. This trial for filing hopefully in 2025.
As we look at an L. Three this was an incredibly exciting trial will talk a little bit more about it but we are two months ahead of time enrollment and on the <unk>.
Financial income net income of $2 million and we've also began paying down our mid cap that we are continuing to deleverage our company. So we can drive greater shareholder value.
This way, we continue to free up cash flow to drive future growth by reducing our interest expense.
As we look at that so many of you may recall from the last quarter. When there were some questions around what happened at the end of Q2, and the inventory and the $30 million number we heard from unit there.
So we plotted here was a continued quarter over quarter, including the $30 million now that its transparent of what our royalty rate as we can show you the breakdown between what $30 million would mean to mankind in terms of our royalty rate on those $30 million in sales and when you look patient demand continues to be very strong quarter over quarter since launch of last.
Year.
The next question I, often get is around manufacturing and I'd like to to hopefully put this to bed as we go forward for shareholders. As we exit 2023, we expect our Newfield finished to come online for 2020 for improving our ability to build inventory and supply the market growth for many years to come.
Look out we expect new bulk capacity come on in the second half of next year continue to bring more efficiency more upside production as Utica gets ready to wrap up their IPF trial, hopefully showing the positive impact for patients as.
And as we look out Youll see mannkind can make 25% to 35000.
Patients here, we can serve with our manufacturing capacity and we can build that up to 35% to 50000 through additional efficiencies without any additional manufacturing plant and as you. All know the IPF market is well over 100000 patients and Youtube, we were able to supply to the upside scenarios and additionally, when we can manufacture we're extremely grateful that unites inverse.
Over half a billion dollars in capex to duplicate our facility there in North Carolina, we look forward to supporting them on that transition.
As we look to turn back to Mannkind Mannkind 101, we've made our first batch since the fire. This is amazing work by our team in Danbury, who did this in record time on top of the Buildout LTV. So on top of the progress of the pipeline and getting ready for IND.
We expect chronic tox data here this quarter as well as FDA feedback on our final protocol design and all of this will put us on track to start our phase III trial in the second quarter of next year and here's a nice beautiful picture of our first thousand vials coming off our production line. Thank you for the team in Danbury for incredible work.
Yes, if I bridge to Afrezza, we hear a lot of noise about <unk> and the impact they may or may not be having on various aspects of the health care system and our consumer.
There's a lot of noise, but you can see not much impact on afrezza and the main change here in Q2 to Q3 with self driven but the overall insulin market in the Gray line you can see the infill market year over year is relatively flat to a small single digit decline on our friends at a year over year, we had growth, but in Q2 to Q3, we made significant.
Difficult changes to our infrastructure to drive our focus to profitability number one we decreased our TNA, we changed our salesforce bonus structure, we extra in the process of moving our marketing team from it from California to Danbury, and we March two sales forces into one that impacted over 30% of all territories. The new team is now.
Place, we put some incentives here in Q4 to close the year strong, but this impact has nothing to do with <unk> and has everything to do with internal change to set us up for 2024.
The next slide you can see here is our first nine months year over year, comparing the first nine months of each year since we launched the product as Mannkind in 2017.
I'm really excited to see that we've doubled our growth over last year. When you look at 21 to 'twenty two versus 'twenty two into 'twenty three significant growth driven by our Medicare part D. 35 dollar Influent program that was part of the IRA with the government.
As we refocus back on and he'll one this is our pediatric trial, where we met the sample size. We originally projected one outcome could it be we needed more patients and that would have dragged on longer length of this trial.
Now expect completion to happen and this is very positive as we can wrap up this trial next year and start to prepare for launch as you may or may not realize most type one diabetes innovation has happened in kids, whether it's been omnipod with the Potter's <unk> com with CGM for insulin pumps that our founder Alfred Mann built.
As I bridge over to inhale three here, we are who we thought 20 years later running one of the largest switch trials in type one diabetes away from the standard of care, which is including the AIB automated insulin pumps, where half the patients in this trial are on an AIB system had switching in record time, we're using the latest CGM.
<unk> achieved seven and we're also including 20% of people, who say you won't see is less than seven. So this is going to show you. Whether you are at goal or above goal. How can you best use afrezza and at once and I'm sorry on a daily Tresiba to show how you can maintain control our improved control hopefully with less hypoglycemia.
Top tier sites and we are well ahead of schedule and looking forward to releasing this data in Q1 and Q2 of next year.
Flipping the card over here to Vigo.
Decline in V. Go has been abated. After a two year decline we are focused on improving the margin for 2024 as you will hear from Steve Our gross to nets went from 49% to 58% mainly because of rebates. We've now started the process of changing these contracts and improving them and we'll provide guidance on our next call as we are in the middle of negotiation.
However, we've had some early wins with Kaiser and some of the DB suppliers and are now working on the Pbms. So we'll continue to watch this closely with Vega. We believe we can continue to drive demand and improving margins as we go forward now I'd like to turn it over to Steve. Thank you.
Thanks, Mike and good afternoon, I'm pleased to review select third quarter 2023 financial results.
Please supplement this call or in the condensed consolidated financial statements and MD&A contains our 10-Q, which was filed with the SEC. This afternoon.
Let's start by looking at the total revenues at the bottom of the table.
Our total revenues grew 56% versus third quarter, 2022, and 121% for the nine months ended versus the same period in 2022, which highlights the second quarter 2022 launch and the subsequent revenue growth associated with <unk> and to a lesser extent our endocrine business.
Which included the results of the Vigo product acquisition from May 31, 2022.
Focusing on revenues from our collaboration with UT revenues totaled $33 million in the third quarter of 2023, which consists of royalties of $20 million.
And collaboration services revenues of $13 million.
Royalties earned and the net sales of Televisa DPI at $20 million as a result of continued strong patient demand for an innovative product.
We recorded $13 million of collaboration and services revenue, which is primarily related to revenue associated with manufacturing <unk> DPI.
This revenue grew 27% over the prior year as we sold more product at a higher price to United Therapeutics.
For the September 2023 year to date period total revenues from our collaboration with UT were $87 million as compared to $25 million for the first nine months of 2022, representing strong patient demand for Televisa DPI. Additionally.
Additionally, the 2022 nine month period included the start up commercial manufacturing of <unk>. So.
By mankind midway through the second quarter and the commercial launch of the product by duty towards the end of the second quarter.
Moving down the table to our endocrine business total endocrine revenues were $18 million.
Our present net revenue of $13 million compares to $11 million in 2020 to a growth rate of 24%, which is fairly consistent with our first and second quarter 2023 growth rates.
Growth was mainly driven by a higher patient demand with underlying <unk> growth of 12% year over year, a lower growth to net deduction and price.
For the nine months period ending September.
At September 32023% to 26% increase was mainly related to increased volume from higher patient demand with underlying paid trs growth of 18%.
And a more favorable gross to net adjustment.
Net revenue from Vega was $4 million for the third quarter of 2023 revenues were 18% lower versus 2022, primarily due to a lower level of patient demand. However, we have stopped the downward trend is <unk> has been about the same amount for each of the first three quarters of 2023.
For the nine months period ending September 30th.
92% increase is primarily related to the purchase of Vigo I May 31, 2022. So the increase over 2020 was mainly from our four month versus nine month comparative.
The next slide shows our revenue growth by source on a quarter by quarter basis from the first quarter of 2022 through the third quarter of 2023, we'd like to service graft because it highlights how dramatically our business has changed in the last two years and how we are executing against expectations.
As Mike pointed out earlier, the royalties from Teva, So DPI have been growing steadily since launch and the fastest growing revenue source in our portfolio.
United Therapeutics management stated during their second quarter earnings call that approximately $30 million of <unk> sales in the second quarter related to specialty pharmacies purchasing product to enable them to get through the contractual inventory levels.
And then the third quarter call held last week, you stated that the <unk> revenues for the third quarter generally reflected patient demand.
We have noted the royalty associated with the specialty pharmacy inventory stocking on the chart in the second quarter 2023 bar, which allows for a clear demonstration of the royalty related demand growth by quarter.
Based on our third quarter revenues, we have a current run rate of over $200 million.
Which approximately 40% represents royalties, which do not have any offsetting expenses, therefore falling straight to the bottom line with the associated cash flow used to fund our pipeline and reduce debt.
Below the graph is part of the earnings or loss per share for each quarter and you can see the impact from the increasing revenues.
In the third quarter, we recognized earnings per share of <unk>. This is not a typo, we have hit a significant financial milestone.
We have now entered a period, where we expect to bounce back and forth between earnings and loss per share I'll call. It a breakeven period and then we expect to grow earnings per share assuming <unk> DPI continues its upward trajectory and the endocrine business unit increases its positive contribution.
The following GAAP to net GAAP presentation will start in the second quarter of this year to better highlight the noncash impact of certain items to our P&L in the third quarter of 2023, we reached a milestone of positive GAAP net income of $2 million, while a year ago looking at the right column with a GAAP net loss of <unk>.
$14 million.
When we adjusted 2023 third quarter GAAP net income for noncash items of stock compensation and a gain on foreign currency. We had net non-GAAP net income of $4 million for the third quarter 2023.
As highlighted earlier, we expect to be plus or minus GAAP breakeven for a number of quarters before we expect to see net income growing on a continuous basis.
I will conclude with some additional comments.
In the third quarter, we started to pay down our senior secured debt based on our contractual obligation to pay the loan over 24 months beginning in September and we expect to be able to pay off this debt over the next two years out of operating cash flow.
We continue to tightly manage our cash flows and had a reduction in cash and investments of only $2 million in the third quarter as we expect to progress towards achieving positive operating cash flow in the near future.
Thank you I'll now turn it back over to Mike.
Thank you, Steve it's never been a better time for Mannkind employees shareholders and partners. We are in the strongest position that we've been and we are well diversified as we look out whether it's our in line brand opportunities our pipeline opportunities or type of ACO DPI growth. In addition to any other business development things that come our way.
We're super excited at the orphan lung business as we look at IPF, and specifically nib and the TGF beta programs. These are programs that have moved up in the priority list in terms of treatments coming down the pipeline in IPF as we've got so many failures, which is not good for patients, but unfortunately, good for mankind as we're now closer than ever to help.
More people in IPF.
We feel very strongly that mannkind two one for rec can provide a differentiated product for those people in a drug that's already approved on the market, but lowering the dose delivered directly into the loan. We think will provide a huge benefit around the gi side effects and hopefully efficacy as people convinced higher.
<unk> been over $400 million in the last year, just in funding and our <unk> inhibitor as well as other inhaled therapeutics around the network with fundamentals.
And as we look at the next three quarters I wanted to share with you the endocrine updates here as well as orphan month, our 2024 milestones will be shared on the next call but for now today as we look out this year with complete everything we said we are and we're on track to wrap up the year strong Andy is on track to file our regulatory the regulatory submission there for India, which will be in it.
Pool, if all goes well in 2024, and one will be fully randomised and hopefully reading out sometime next year and <unk> three will be read out hopefully by March April timeframe.
On the orphan lung one on one is on track for submission.
Expect to initiate that trial in Q2, and 290 submission is on track and we'll be doing that study in phase one healthy volunteers early next year.
We've never been and we've been here death, and we take seriously our fiduciary responsibility to shareholders.
As we think about our future expense management capital allocation is the number one most critical thing we have to do which is really about deleveraging the company investing in our growth drivers and improving shareholder value.
Here are many shots on goal to think about as we close out today's call them ready for Q&A number one.
<unk> is 101 <unk> is a real unmet need and just to put some context here for every thousand patients we get it's approximately $100 million in revenue.
<unk> <unk> hundred one has huge upside until we get this through phase one I don't want to guess how big this could be but it could be a nice huge inflection for our company and our patients.
The ACO DPI, we can't always guess where that will be but as you know UTI is a goal for 25000 patients in 'twenty five and shareholders can get to that 10000 20000, what that means for <unk>. So what does mean is 250 to 300 million in revenue for every 10000 covered patients.
We're super excited and anxiously await the U T Teton study Readouts for IPF.
Really excited now about our pediatric and Hell, one continued vigo stabilization and hopefully growth and our pumps parent child on <unk> III as well as an opportunity to bring our friends of the patients around the world. Thank.
Thank you again for your patients it's been a long quarter and apologize a better stock price not anything we can see what we'll call the decline to last day or so, but I will continue to progress and everything we can to make this a great company and a great investment for shareholders. Thank you we.
We'll now take Q&A.
Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again please.
Please standby, while we compile the Q&A roster.
And one moment for our first question.
Our first question comes from Gregory <unk> of RBC capital markets.
Great Good evening.
Michael Congrats on the progress to date and thanks for taking my question.
As you certainly.
That commitment to the manufacturing on DPI and kind of get that in the right place I just wanted to ask a little bit on on Afrezza and while you are guiding to sort of the <unk>.
<unk> series of trials I'm, just curious if you can articulate a little bit about how you see that actually shaping the trajectory of afrezza and depending on the outcomes of one and three.
Is that kind of shape your commitment to the endocrine business into it present itself.
Okay great.
Great questions I think the data is going to drive some of these decisions right. The good news of mankind, we have the capital to place bets, if we see opportunities to grow faster.
We are our goal is to run the business to profitability, but if we can see a way to cause a major inflection in that growth curve. After all this time I think we more than excited to place that bet to show shareholders, what can really happened with afrezza the.
<unk> III trial is a groundbreaking trial in our mind, it's one of the largest switch trials done and it's got the new dosing regimen and I didn't talk about that but one of the things we got at the FDA to agree to as we could you can basically double the dose upfront and we're testing the first dose in the office to ensure patient safety and comfort.
Well, hopefully able to see and we've already run those presentations that we are crushing the first two hours of post prandial control that.
That carries out through a trial over 12% to 14 weeks or six months that should provide opportunity for improved time and range lower hypoglycemia as well as hopefully better overall efficacy and tolerability and sustainability on the product. So that the trial results are going to drive a big part of that outcome, but we've done everything we can after all these years either.
Pivotal trials I would've loved to do years ago, but it's a stepwise way to work with the FDA to get the dosing right to get the thought leaders right and neither U S trials. When you think about it we have 60 trials top centers in the U S. Many academic centers. These people who've never had real exposure with inhaled insulin. So it's a real opportunity to change our future and I think we need the good.
Data to support that but I think we've done everything we can to make sure.
Data is the best that we can possibly hope for it and we'll be ready to call that inflection if we get good supporting data behind it.
Got it no that makes sense and maybe just one more maybe for Steve perhaps but.
Just remind us on the economics on DPI, just for our own modeling purposes that we kind of get that right and to what extent are the royalties fixed dynamic and just how that how that flows through thanks again, guys and congrats on the progress.
Thank you, Greg I'll turn it over to Steven Thanks, Greg we have two pieces to our.
Contract with United Therapeutics to show up in our P&L.
First under.
Collaboration and services revenue.
Is the revenue associated with the manufacturing of the <unk> DPI product that is on a cost plus basis. If you look in the P&L, you'll see revenues and the costs associated and Youll see a margin little over 20% for collaboration services this quarter that fluctuate up and down depending upon our revenue recognition with United Therapeutics.
Some other areas outside of the actual manufacturing of the product.
And the other is royalties our royalty rate is.
10% on net sales.
And.
Net sales for United Therapeutics of Taipei, So DPI to their customers.
It does not vary by sales threshold.
That's great. Thanks again guys.
Thanks, Thank you Greg.
One moment for our next question.
And our next question comes from Ron <unk> of Oppenheimer.
Hi, guys. This is Ryan on for Steve Congrats on the quarter.
I just wanted to ask about gross margin. It was really strong again this quarter.
Guys can you give us a little bit about your outlook for margins sequentially and into 24. Thanks.
Thanks, Ron the margin this quarter for our commercial products was 78%.
It was up sequentially from previous quarters, mainly around two things happening one is we're getting a better handle on our margin for the Vigo product.
And the second is we're getting increased efficiencies and afrezza.
Factories, producing both Afrezza and Televisa DPI. So we don't give forward looking statements, but I think that the 78% feels in the right territory for right now so I think it's a good number if youre thinking about modeling going forward.
Thanks, and then maybe one more.
You guys are you guys modeling in any impact from gel two lines on your diabetes business.
Now and for the future are you seeing any impact and maybe on any of the products in the pipeline are you thinking about something like that.
Okay.
So.
When you look at our friends at about 55% of our business is type two and <unk> 45 per cent is type one that fluctuates from time to time, but in general our focus since last year has been growing the type one market on our clinical trials around type. One. The reason that's important is <unk> are not going to change a type one patient need for insulin <unk>.
A meaningful way.
And so as you think about the type two market. Eventually most patients are still going to need mealtime control. So even if they go on <unk>. We already knew there was a seven to 10 year delay from the time somebody needs mealtime control to when they get it and my guess is GOP is you're just going to push it off a year or two but as you can see the insulin market and the diabetes market is continuing to grow.
So it's a pandemic in this country and I don't see a need for instance, going away all of the growth slow because the gop's, absolutely, but will the impact of Afrezza, absolutely not I don't see that as a major impact given that we have less than 1% of the share where we target doctors and 2% in the whole country. So we've been able to increase our market.
They're significantly where we put reps versus when we don't but the gop's are used much earlier in our population is much sicker. So we just have a very different segmentation aware afrezza plays.
We don't expect much impact there.
Great. That's very helpful. Thank you guys.
Thank you.
Thank you one moment for our next question.
Yeah.
And our next question comes from Oren <unk> of H C. Wainwright.
Thanks, guys I have a few questions. There is an exciting time at the interesting I'm just covered the NIM through.
Through the tough times.
First just to clarify quickly on the discussion around the transitional Terry This breakeven period, you talked about sort of fluctuate back and forth is that for non-GAAP as well or is that just the GAAP number.
And is that just a function of R&D investment timing or.
And potentially even just gross profit going to be lumpy and this year.
Yes, so without getting really specific.
It's probably going to be for GAAP and non-GAAP as you can see there's not a tremendous amount of.
Amounts that go between the two and we've got this foreign exchange gain or loss depending upon the.
U S dollar Euro exchange rate because our purchase commitment for insulin is done in euros. So that can swing in one direction or another over quarter by two or three or $4 million. So I think just over the next few quarters, we're going to jump back and forth where would it be spending a little bit more on R&D as you would.
Based on.
Mike presented on the pipeline, but we're going to have revenues that are growing at the same time particular expect revenues to grow at the same time.
<unk> DPI royalties in particular.
As well as our endocrine business.
And I think some of the timing of the FDA feedback and Windows R&D expenses kick in some of that would be a cap issue. So it will be a cash flow issue, but in general we got enough cash to fund those things.
But until we get some of the FDA clarity.
The IND filed and approved.
Just going to address a little bit of fluctuation.
Got you got you.
Talking about inhale.
I guess that pumps switched out in particular.
I think we talked about this last quarter, but can you remind me what do you think the biggest assuming the data is compelling and what you hope to see what do you think the biggest immediate impact from that is is it the education and awareness hopefully dramatically increasing amongst physicians in type one patients as a result.
Or is perhaps the bigger lever here.
The final go economic argument, you may be able to make with payers and hopefully we'll be able to make with payers with regards to relative cost of expensive pumps and.
Mike would you add significantly better access over time.
Thanks.
I think there's a couple of things arent you hit on a couple of them. The first is lung safety so getting in the kids and showing expected long outcome that we would expect and then hell free some of our latest data on F&B. One changes has shown that the control arm is worse than the.
Our friends are and so I think really showing new lung data and diverse ability of that is going to be really important and we feel like we've now measured this in a certain way to make a consistent in each trial and timing that reverse ability. So that's going to be an important endpoint combined with having a good pediatric outcome for FDA review and approval those couple of things will give us.
A huge halo effect. After next year will be 10 years since FDA approval of Afrezza and that will give us hopefully the length of time on the market. The lack of any safety and surveillance plus these new trial Readouts I think we're all going to be really critical then there's two other things I would add are three other things number one is education.
Now.
Really well run out thought leaders in academic centers running these trials, who can now be on podiums, who can now be in publications, who can now do CME that we just didn't have before and I think thats going to be critical in conjunction with marketing and sales training, we're really putting a lot of investment in our sales force right now on training skill sets clinical knowledge.
<unk> and <unk>.
Really teach them, how a patient lives with type one understanding insulin pumps and what that's going to mean to a patient and how they position of friends in that market.
And then as we think about Europe I do think didn't health III trial be really important to think about the pharma co economic because in Europe. They do care about the total cost of care being hypoglycemia medical as well as pharmacy and I do think if we can show.
Good outcomes with a pumper without a pump that it doesn't have to be better just has to be as good as there is a significant cost to consumers as well as society 40 agents on pumps and pods and thats going to be something important as we look at Germany, Italy U K, they're paying more and more for diabetes technology and we think now is the time to bring new innovation to Europe as well.
But having this data set and the pediatric dataset will be important for the global market not just the U S market, but it will help us in the U S. I can tell you just talk to some of the payers. This past week and we expect continued Medicare coverage. In fact, we've got Medicare to update their website last week around inherent from being covered for 2024 because of the IRS.
<unk>.
We know that the price of influence coming down we don't expect any negative formulary positions against us and I think as we go into 2025, we will look at how do we use V go and Afrezza to open up access together 24 is going to be a transition year for everybody given the IRA impact on society, and drug companies and discounts and Pbms.
Sort of confusion happening for 'twenty for getting ready for 25 years, so that dust will settle but we expect the phrase that continue to have good formulary coverage as well as we go as we go forward.
Okay and you anticipated my next question just regarding IRI.
It sounds like so at the end of the current business.
It's a little bit uncertain pushes and pulls there but for tie basically DPI I know thats users launch, but is your understanding that that is only a tailwind as far as to whatever extent it has any impact in 2024.
Yes, I don't I mean, I think I'll, let <unk> comment obviously for their future type Asa, but what I would say is the Medicare part D, which as you know <unk> was a part b for nebulizer.
And the part D is what the inhaled version is covered for DPI and so those patients right now have a huge out of pocket cost, which does prevent some of them are switching over and so as you think about that basically go into the next year and the following year that out of pocket costs should be kept in roughly around 3000 next year in 2000 and following here if I recall and hopefully that will help continue to provide.
Incremental demand beyond our current trends for Tavis a DPI.
And so thats something we anticipate as we go forward.
That should be a net benefit to patients as you kept those costs.
As well.
Alright, Thanks I appreciate it.
Yes.
Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced Twitch draw. Your question. Please press star one again.
One moment for our next question.
And our next question comes from Andreas argue reduce of Wedbush Securities.
Thanks for taking good afternoon, and thanks for taking my questions here Congrats.
Congrats on all the progress.
Just two questions from us the company's transformation to an awful long story is certainly exciting can you provide us with the next steps for submitting our IND for <unk> hundred one and <unk> 201, Ips and then also how you guys are thinking about the phase three trial design endpoints treatment duration et cetera.
<unk>.
I want to make sure I heard your question is a little fuzzy on my side for <unk> and <unk> phase II three designs. So.
On the IND, we are the number one long haul and the tenant the manufacturing stability. So everything else is pretty much on track to be ready in terms of study reports are filing for the IMD and I remember you were trying to get that filed for Q4. So we were pretty well on our way for that and so at this point, it's really can we bridge some of the clinical supplies from Germany to the U.
For the data and for the inventory for the clinical trial. So thats for 101 and that's on track for an early Q1.
Q1, I'll say filings, but if we can find a way to get there faster based on our FDA meeting we have coming up that we will do that on the 201, it's just making the clinical supplies, which are in the process right now and getting those up on stability.
In terms of getting a three month data, we need to file that IND.
But both of those are on track, it's mainly around just making sure. The manufacturing is up and running Unfortunately the team that's making 201 had to make 101 on top of everything else and so.
They are stacked on top of each other but they are working hard to get them both ready for filing. So those are the main things.
That are the less steps here all of the Tox and everything else pretty much is ready to go.
Yes.
Phase II three design, we actually have an upcoming FDA meeting, where I'll provide more clarity after that because we are going to the FDA to try to change a few things we have previously.
We're focused on.
Looking at the New era case data that just came out with their quality of life as well as some of the dosing. We think there's a way to continue to streamline. These trials as you may or may not know, we hired a new head of R&D Dr.
Dr Burkhardt and he joined US back in May So we've taken a fresh look at all the programs that trial, the FDA feedback and Theres a few things we thought could be a little bit clear and ensure the trials go as smoothly as possible as fast as possible. So that we will get that feedback in the next month and we'll share those updates Hello, hopefully JP Morgan I'm on the trauma official trial.
Design that we're comfortable with.
Okay, Great I appreciate the color and congrats on all the progress.
Thank you.
Thank you I'm showing no further questions at this time I would like to turn it back to Michael Castagna CEO for closing remarks.
Just thank you everyone. I think you can see we've made a lot of progress we continue to grow our revenue we continue to help more patients and we continue to move the pipeline forward and really our goal to improve our mission to give people control of their health and the freedom to live their life as you look at each of our targets. These people are really suffering and in some cases. They are three to five years to live.
Everyday counts to get these patients are treatment as soon as possible safely and effectively in the clinical trials until we get into the market.
Everyone for everything we look forward to closing out the year strong and I will provide you continued updates as news comes in thank you again.
This concludes today's conference call. Thank you for participating and you may now disconnect.
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