MannKind Corporation Q1 2023 Earnings Call
Okay.
Good afternoon.
Noon and walking to the Mannkind Corporation 2023 first quarter financial results earnings call.
As a reminder, this call is being recorded on May nine 2023, and will be available for playback on the Mannkind Corporation website. Shortly after conclusion of this call until may 23rd 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.
Earnings release, and the slides prepared for this presentation.
Joining us today from Mannkind are Chief Executive Officer, Michael Castagna, and Chief Financial Officer, Steven Binder.
I'd now like to turn the conference over to Mr. Castagna. Please go ahead Sir.
Thank you operator.
Hope everyone is having a great afternoon.
Our mission is to give people control of their health and their friends and loved life, what we call that it's late argument.
We're really excited about our first quarter highlights of 2023.
Number one our UT collaboration is strong patient demand is driven royalty revenue growth of 29% versus Q4 2002.
We're currently undergoing manufacturing capacity expansion, which I will talk later in this call.
Pipeline is quickly moving ahead with inhaled what that means going into adaptive phase two three.
And we had a very successful.
FDA Mannkind 201 in which we receive written comments on how to proceed.
Our endocrine business underlying business is strong with our present growing 26% versus 2022, and we had sequential growth over Q4 versus the traditional decline that we've seen in the new year.
Additionally, we are kicking off our first large phase four trial in health rate called pop spirit, which is going to be head to head against the standard of care and that should be enrolling hopefully late this quarter early next quarter.
And in Vigo, we dropped that product in our Afrezza sales bag starting in Q1.
To compete and you grow throughout Q2 and beyond.
From a liquidity perspective, we had $167 million in cash on hand, which is only a $6 million decrease from the end of last year and our net loss per share decreased by 60% versus last year as well to continue to see the progress we're making in our growth engine versus managing our cash balance.
Annual revenue to mankind should be between 202 hundred $40 million, which would include the collaboration services as well as royalties.
Yeah.
On our endocrine business operationally, we look at Medicare at $35 co pay that happened in January one of this year is driving favorable impact in Q1.
We continue to see these patients grow and impact on our business as we look at Q2 and beyond we.
We had lower Afrezza gross to net book as we continue to shift our direct purchasers to specialty pharmacies out of the wholesale channel.
And now our sales force has been cross trained and we have about 65 reps selling both <unk> and our president and about 15 reps selling vehicle.
As we've previously communicated we anticipate the interconnect business units to be breakeven by gap by the end of this year.
Additionally, we are trying to really enhance the scientific understanding what president and we have three trials that were expected to read out over the next 12 months number one in <unk>. One we have over 35 states and we've seen a lower patient drop out the unexpected.
Inhaled too which is what we're referring to is the civil a phase III trial for India, We expect that data readout here momentarily in the next few weeks I don't know if they'll publicly announced to present the data at a future conference.
At least know that data as we go into a filing for the second half of 2023.
And then held three recall pumps bearing which is afrezza to receive its ex comp hence the three versus standard of care that will be the largest adult trial, we've done with top tier kols across 20 U S sites.
As you look at the Gov, and Rx is our leading indicator, which grew for the first time in two years. We've made several changes coming into 2023 that impacted our <unk> number one and we ask that.
We cancelled the cash pay card touches a good rx that can be administered with a pharmacy.
Number two in April we ended our free goods program.
And number three we upped our copay card a little bit so that patients have to share a little bit more on the cost as we go forward. All three of these things combined would have impacted Q1, <unk>, but as we look at <unk> being a leading indicator. We can see continued growth from this point forward now that we've integrated into their friends on Salesforce.
Therefore, we do see we are on track to meet the high end of our forecast 18 $22 million.
Yeah.
As we look at Afrezza in 2022, we're really focused on accelerating <unk> growth. This was a complete shift from top to bottom the organization and it was a major focus of our sales force and you can see every quarter. We continue to improve <unk> growth, which is what we needed to see happen faster than to Europe in order to grow to your actions.
And you can see <unk> again is the leading indicator here as you see Q3, 18% growth <unk>, 10% growth Purex and continued all for Q4 and Q1 allows the Q1 upside has been the Medicare $35 Copay, where we're seeing over 90% approval rates through our reimbursement hub.
As we close out the first half we see several key milestones in the first half going into the second half.
We completed the first two which is bigger than the upfront of the sales force bag.
Medicare at $35.
Additionally, we have didnt heal three kickoff, we expect to have our investigator meetings here in about a month and keep those patients off hopefully Q2 Q2 going into Q3.
In Q3, we should have our Blue Hills, <unk> visualization, if you'd agree with that comp CGM data with our inhaler.
Q4, we expect to be fully enrolled with inhaled one fully enrolled within health read as we close out the year.
Now I'll turn it over to Steve.
Thanks, Mike and good afternoon.
Pleased to reviewed select first quarter 2023 financial results.
Please supplement this call by reading the condensed consolidated financial statements and MD&A contained in our 10-Q, which was filed with the SEC. This afternoon.
Our total revenues grew 239% versus the first quarter of 2022, which highlights the revenue growth associated with high basically DPI and to a lesser extent our endocrine business.
Revenues from our collaboration with United Therapeutics totaled $23 million in the first quarter of 2023, which is made up of royalties of $12 million and collaboration and services revenue of $11 million.
Royalties earned on net sales of <unk> DPI of $12 million was the result of strong patient demand and a low double digit royalty rate.
We recorded $11 million of collaboration and services revenue in the first quarter, which was over four times. The revenue of a year ago, we were not yet manufacturing commercial product for Ut differed much of our revenue recognition later in the manufacturing contract right.
Moving down the table to our endocrine business total endocrine revenues were $18 million, which are made up of Afrezza net revenue of $12 million in vivo net revenue of $5 million.
Our present net revenue of $12 million compared to $10 million in 2020 to a growth rate of 26%.
Both is mainly driven by higher patient demand.
With underlying <unk> growth of 26% year over year, and higher price, putting a more favorable growth to net adjust.
Our gross to nets went from 39% to 38%, reflecting a continuing shift from using full line wholesalers using specialty pharmacies with lower fees.
Net revenue from <unk> was $5 million for the first quarter of 2023, and there was no comparisons to prior year due to the product being purchased in the second quarter of 2022.
Since acquisition vivo net revenue totaled <unk> 18.
$18 million.
And on track to achieve the high end of our original forecast of $18 million to $22 million a period of 12 months post acquisition.
The next slide shows our revenue growth by source on a quarter by quarter basis from the first quarter of 2022.
First quarter of 2023.
The mix and growth of revenues has significantly changed over this period as we've added type ACO DPI royalty revenue revenue associated with the commercial manufacturer of practice of GPI.
And sales from vivo all starting in the second quarter of 2022.
Again across the time span our first quarter of 2023 revenue total revenues grew 239% versus the first quarter of 2022, reflecting not only the new sources of revenue, but also the strong growth in <unk> epi related revenues.
The next slide shows the impact of cash inflows associated with time based for DPI, I've had and our cash cash equivalents and investment balance.
You can see the inflection point happening in mid 2022.
Starting with the third quarter of 2022, our catchment investments quarter on quarter change with owning a single days the first quarter of 2023 being reduced by only $6 million.
We continue to tightly manage our cash outflows, while benefiting from the increasing revenue is associated with high base with DTI and their intergroup dividend.
To move the company towards profitability and being cash flow positive.
Also note that we have started to increase our investment in the development of our product pipeline, which is quickly becoming our next lever of shareholder value.
We believe that our current level of cash cash equivalents and investments anticipated operating cash inflows and outflows will allow us to adequately invest in and grow our business without a need for any follow on stock offerings.
And finally, we haven't spent much time on EPS in the past, but as we grow our revenues and manage our expenses the loss per share has been significantly reduced as we progress down our path to profitability first quarter loss per share of <unk> <unk> versus a loss of <unk> 10 per share in the first quarter of 2022.
Thank you and now I'll turn it back over to Mike.
Thank you Steve.
And you all can see we have a very robust product pipeline. In addition to our marketed products.
<unk> to be able to file an NDA in the second half and hopefully get ready to relaunch back in Brazil early next year.
As we look at the pipeline <unk> walnuts ways to get into patients here in the second half and the tenant.
There's really move forward quickly as we've just received dosing data and our data model as well as the Tox data is ongoing we expect to be able to put this product in humans late this year early next year.
Dna's Alpha TGF beta continue to progress nicely well updates on those as we progressed here.
Part of the story, we always get from shareholders is what what's next we don't believe we have a lot of value on our company as we look at our pipeline momentum building over the next 24 months.
Several studies on our present, which is basically redoing a lot of the work that was done over a decade ago, but the new insights around dosing and how do you titrate up quickly and manage basal at the same time. It new studies are based off the small pilots that you've done over the last five years and we're excited to see these results in your future.
On the orphan side we.
We have several assets moving forward development over the next 24 months that you can see here going from IND to phase one to submissions and phase one and continue to progress this very rapidly.
As I look out and wanted to bring you some perspective on how these key value drivers create shareholder value as we go forward.
The first is the pipeline Manheim 101, we expect to dose this.
While it should take roughly 24 months.
In terms of dosing and enrollment.
Every 1000 patients. Once this is approved we would expect approximately $100 million in revenue.
This is an orphan disease at somewhere between 60 and 100000 patients alone here in the U S.
Mannkind 201, we expect to be dose higher first half of 2024 and progressing rapidly into phase III from there.
Hi, basically DPI for every two patients royalty and collaboration service revenue should be in the range of $200 million to $240 million in revenue.
To remind you <unk> is a <unk> study readout for idiopathic pulmonary fibrosis.
The upside to this forecast.
And then our endocrine business, we have pediatrics. So when we look at diabetes over the last 20 years innovation continues to happen with kids, we really do believe once we get these results we should be able to help a lot of children and parents manage their kids diabetes and every 10% market share there is roughly $150 million in additional revenue on top of it will.
At that time.
We're excited about the India launch upcoming in the data read out there as well as this new pumps bearing study that we're doing to really show not the pumps are good or bad but that there is an opportunity to delay using an insulin pump and start within a handful and delay the skin damage that can occur over the next 30 40 years.
<unk>, we've put a stabilization in Brooklyn in place you're starting to see the early fruits of this labor as we look at the type two market one of the things. We do see is a lot more people coming in with insulin delivery devices in type two and Ashford Reits all time. So thank you for that.
Yes.
Talk about our annual shareholder meeting.
Mankind annual meeting will be may 25th at 10, a M. This will be conducted live via the internet to reach more shareholders. As we typically are seeing three or four times more shareholder silent for this that we had no my feeling and hence why we want to go this route.
Are those shareholders interested in joining us to see temporary at some point in the future. Please reach out to our Investor Relations.
All information on this meeting and instructions for voting can be found on your website or a proxy.
Several proposals that he'd be bolt ons that we're endorsed by the board in ISS supporting all proposals.
I wanted to close out just letting you know over the next two or three weeks or several RSV grants that are scheduled divest our granite in years past as a result, you will see multiple form fours being filed by executive leadership team members to effect to reflect these events as well as the cell to cover transactions that will be conducted under <unk>.
Trading plant.
Last year to cover their tax liabilities.
Rest assured that we all believe in the long term future of mankind, but the IRR is expect to be paid in cash on our issues vest. So we need to address that obligation I just wanted to add some context for the various one quarters that you'll see throughout this month I want to thank you again, and we will open up for questions.
Ladies and gentlemen, if you have a question or comment at this time. Please press star one one on your telephone keypad.
If your question has been answered or you wish to remove yourself from the queue simply press star one again.
And if you have a question or comment please press star one one on your telephone keypad. Please.
Please standby, while we compile the Q&A roster.
Okay.
Our first question or comment comes from the mine.
Matt.
From HC Wainwright Mr. Loopnet Your line is open.
Hi, Thanks for taking the questions and congrats on another strong quarter I'm sorry.
So I listened to the United Therapeutics call in I guess, they couldn't have been any more bullish about the DPI highlighting that demand.
I think even outstripped expectations, which has actually led to some surprising.
Dynamics with inventory and demand that specialty pharmacy is not being able to be satisfied. So can you just.
Confirm for us your expectations that.
Through this year as you execute on that.
The capacity expansion initiatives you highlighted in the script and then the bigger expansion next year are you confident that you can meet all the demand through the rest of this year and into next year and I have follow ups. Thanks.
Thank you Laurent can you hear me okay hopefully.
Okay. So yeah, obviously, we tried to give a little bit extra clarity on this call given the UT comments last week I think as far as we can look out we've been close with Ut on a daily and weekly basis to make sure. We're supplying patients every time.
We made some changes here in Q2.
That will be in effect and should be in full production mode by June .
Those are happening as we speak.
That should make sure we have more than enough adequate supply and at the same time allow the pharmacy to build up the contract inventory that U T as mentioned in the past.
We weren't as close to some of that that those contracts and what that obligation was as we went out the door last year to launch the launch it took off very fast.
I think.
Conversion has gone very well, but you start to have gone well I think overall it's me.
And beating expectations.
We had to make sure we increase our ability to continue to supply the second half of this year, which.
We're doing it again nothing on the <unk>.
Short term do we see any impact I was really getting out of long term.
Patients may films, we should be comfortable to be able to supply all the way.
Through the future.
Okay, and I guess, you sort of segue into my next question speaking longer term.
I was surprised on their call to hear that they are in fact investing half a billion dollars to build their own.
T owned.
<unk> for <unk>, Asa DPI, too I guess triple or even theoretically quadruple your expanded capacity even for next year.
So I guess just you know you did highlight that.
You know 200 plus million in revenue from every 10000 patients and I guess, if they're already investing behind that now it must be pretty confident in.
And some pretty extreme growth potential. So how are you planning for the longer term with us.
A real possibility of a couple of extra a couple of hundred millions a year and royalties coming in the door. How are you planning for our investments on yearend now that you know, we're coming not only out of cash burn but.
Pretty a pretty big surplus whether it would be a pipeline investment M&A.
And on the flip side is it have you even thought about potentially breaking up.
And maybe selling for some large amounts of dollars.
The franchise to U T.
Yeah.
Lots of questions on that I'm, sorry run on questions.
I think we wanted to show kind of wood every 10000 patients equal because.
When do you want us to it was 10000 25070 5000 and you can see this as a meaningful engine growth driver for <unk> client and our shareholders.
Bob.
I think any company, who is going to have $1 billion plus product wants to have a reliable consistent and backup supply. So we're fully supportive of Youtube buildout of our second facility because as you know you've been the Danbury Opex a wonderful facility a large it can do a lot, but it's one facility and so I think if you really.
Looking at the future where U T is going having a second facility come online as a backup whether we're the backup or backup I think all of that's going to be.
The years in the making its not going to these.
These things take.
Five to seven years to build sometimes and certified so I think we got time to worry about some of those details but at the end of the day. There is definitely things we're doing in IPF.
The scale up that could increase that.
The capacity with the Danbury to more than meet the needs over the next three to five years. So we feel very good about DAYBREAK meeting current demand Ut having a backup facility our second facility as they look at increasing global supply.
It's all of that that positive for everybody.
<unk> got to be a cure.
In terms of what Mannkind will do with that excess capital coming in I think you see we've been building a pipeline over the last four years.
Anticipation that that Asa would do well mannkind would be I'll be able to self fund our R&D and ultimately launches because believe me, we'd all be happier as shareholders and employees is the money going out the door <unk> was going to mankind and I think that's one of the things we want to make sure. We can do whether it's MTM attended either.
Real assets real value that we've been building for the last three or four years will now finally, we start to enter patients at launching over the next three to five years. So.
So we're excited about the future and with the capital deployment and that's our number one job is to make sure. We are appropriately deploy that capital to drive the best opportunities for growth and you look at the company. We've done a lot when we didn't have a lot of capital.
Now imagine what we can do to drive faster growth that'll be you'll have adequate capital and that's what we're doing we're taking a bet for example on the nail free.
I'll bet, but it's a big bet that you could show you as good as an insulin pump or better.
We could take those types of best but that's how you're going to really change.
Your trajectory for the company.
Alright, Thanks, I appreciate it back in the queue.
Thank you.
Thank you.
Next question or comment comes from the line of Brandon Folkes from Cantor Fitzgerald, Mr. Folks. Your line is now open alright.
Alright, thanks for taking my questions and congratulations on the quarter.
Maybe just following on from the prior question can you just help us think about the U T announcements.
Potential future Danbury expansions.
As always contemplated.
Would you do you have an obligation to buy from Mannkind first and then you see.
Hence the backup.
I don't I think it's too early to speculate.
The supply chain.
Contracts, we have a 10 year supply agreement with Ut they've invested a lot of money in the plant and that people.
I don't see that changing in the near term or mid term.
As you look at the pipeline, we have a couple of assets, we're moving into the Danbury for manufacturing for commercial.
And so theres going be a lot of activity positive at Danbury, regardless of beauty as.
As we look out in the future.
We would expect to be able to continue to supply out of Stanford or additional unique capabilities. There that take time to duplicate as it were a single purpose facility and the only one of its kind in the entire world. So.
There's a lot of work to get ready to do that a second time.
Okay.
Thank you. Thank you very much.
Thank you. Our next question or comment comes from the line of Gregory <unk> from RBC capital markets. Mr. Renzo. Your line is now open.
Hi can you guys hear me okay.
Yes, Hi, Mike and team, it's a niche on for Greg Congrats on the progress this quarter and thanks for taking my questions. Just a couple for me firstly on the new use their own facility to support growing demand for <unk>.
Based with BPI and continued ramp up of commercialization could you remind us of any economics are incentives in place and the degree of your involvement to get this facility up and running and I do have a second question.
I think we have every incentive to make sure the facilities up and running.
He gets ready for the Ips I hope with that indication goes well, that's a huge upside to everybody and I think that's enough incentive for us to make sure we meet the timelines.
We started this a long time ago.
Honestly some of the beginning of equipment that's important for the scale just arrived yesterday.
So we're installing equipment to build out moving forward.
But we're super excited the team is working nine data make sure it's ready.
And we'll be validating that equipment here in the fall and hopefully having a commercial product offered at some point 2024.
Great great. Thanks for that and then secondly, just on the macro side do you have a sense of how the current inflationary environment has affected opex in terms of relative change in capital costs over the past 12 months to 24 months just to get a sense of any potential factors from under the covers I appreciate it and thanks again.
Steve Binder I'll take that one.
Inflation in our costs are probably up in the low single digits nothing that unusual in the marketplace.
Sure.
We don't see anything.
Unusual coming our way on the manufacturing side or the Opex side. So planning purposes, I think that that should be fine if you're modeling that out.
Great. Thanks.
Thank you again, ladies and gentlemen, if you have a question or comment at this time. Please press star one one on your telephone keypad.
Our next question or comment comes from the line of Thomas Smith from <unk> Securities. Mr. Smith. Your line is open.
Hey, guys. Thanks for taking the questions and congrats on the progress during the quarter two questions from Us first.
Can you comment on whether youre seeing any impact to our president from the price reduction that were announced for injectable insulins earlier in the year and then.
Secondly, we saw the strong data for some tighter stuff with CAH back in March just wondering if you could comment on how you see potential for Patterson to approval.
I can tie basically BPI use either positively or negatively.
Okay.
I think let me take the first one on surpass up I E.
I wanted to offer to Ut in terms of the expert ph market I think it's a great drug everything I've seen it's being used in combination there's 50000 patients with ph.
I think there is enough room for everybody as you know for us of Asa GPI is off to a very strong start and I.
I think that's that's.
For patients with Mannkind in U T.
I'm sure, there's probably will have a place in the market when it's approved and ultimately the FERC rutile.
Best books.
On a present.
The insulin price reductions have not had any major impact or even small impactful mankind. In fact, we're having some of our best weeks over the last month.
In terms of demand and outflows that we see at wholesalers. So for our perspective of friends is on track to meet or beat our expectations, we don't see any risk as it pertains to the insolent price declines that happened.
Novo Center.
<unk> and Lilly.
Lilly and you have to note that they only took those prices on drugs that were exposed to Medicaid.
LTE is a 2024 that did not reduce the price of their innovative basal insulin they didn't do it on a non interchangeable basic lot for example, and they didn't do it on <unk> desk. So all the legacy installed all the newer infill that been approved the last five to 10 years have not had price reductions, it's only the 20 year old.
That are really exposed to Medicaid best price at Medicaid penalties for the price increases. They took so a lot of companies are going to deal with that in 2024 I'm sure. The first couple of these three because they are the biggest in terms of.
What's happened over the last 20 years. However, we've looked at our numbers our price points, we're comfortable with it we think our value proposition economic support the payers.
As warranted and that's another reason why we're going out to do the studies, we're doing hopefully show cost of an insulin pump plus better time and range plus a one C V juice at a total cost of care and so we think that's really important to payers not just in the U S, but globally, but we don't anticipate any fundamental changes to afrezza.
We're seeing strong growth as we closed out March and April and.
And we expect that to continue the rest of the year.
Got it that makes sense, thanks for taking the questions.
Thank you.
Thank you.
Our next question or comment comes from the line of Steven Lichtman from Oppenheimer. Mr. Hickman. Your line is now open.
Hi.
Good evening guys.
Yeah.
Question on Vigo now than it's been in the field for you guys for several quarters.
Are you seeing cross selling.
Building with Afrezza.
And do you see opportunities.
Looking ahead for those types of synergies, particularly with with Vigo stabilizing it. So thank you Mike.
Yes, Thank you and I know you've followed <unk> for a long time, we committed to $18 million to $22 million last may were hitting the high end of that 22.
As we expected I think the question is how do we go from 22 to beyond and I think it's really important that we.
Puts us into Salesforce, we know it takes three to five months for those reps to get bunches in services follow up Theres training all that's been happening we're hearing really good progress locally on the on the frontline.
So I think that's important we're seeing some early indicators with <unk>, but that's positive. We got you know unfortunately offset that with the white space, where theres Trc is dropping off due to either the commercial changes we've made to increase the profitability of the asset.
And that's been our main focus here is how do we optimize vigo given the cost structure of the manufacturing the rebates that are paid to payers. So for example, we're moving that patient hub really focus on retail it's a very different product than our friends are where we're pushing patients to our reimbursement hub and not rebating and so.
There are two different models, we've kind of execute that at our salesforce level. I think we are hearing that Vigo doctors, who have written historically are opening the door for our present. They are reps are getting into places they would have never gotten in which was part of our strategic move.
That integration just happened in the last 12 weeks and I think we'll continue to see positive impact on our present as a result of the integration, but also continued positive momentum on <unk> as we close out Q2 would be up.
It's a great product I've seen it firsthand we've.
We've had some recent upwards.
We think if you look at Omnipod go back to some more type two I'll call until delivery devices coming to market.
That should rise everybody up in terms of demand in type two we think we have a very simple to use patch pump.
At the end of the day.
An incredible product friends is incredible product and now we have reasons to shop to offices across seven delta customers.
And so that's really been a.
A major focus this year is narrow our focus and go deeper with customers.
Physician Vega for type two and are present for type one and that's happening.
Consistently as we look at every week.
Great that's helpful.
And then Steve gross margin looked.
Firm again this quarter pardon me, if I missed it but what was the Afrezza gross margin particulars, we disaggregate that from Vigo and whats your outlook.
Sequentially as we look forward here on gross margin.
Yes, Steve as we've combined Afrezza in V go into the endocrine business you know, we're gonna be just disclosing endocrine.
Product gross margin going forward.
As you can see it.
Just under 70% for combined.
We disclosed this in prior quarters.
Can take those.
Gross margins from a modeling perspective, and I think that would put you in the ballpark going forward.
Okay fair enough thanks, guys.
Thank you Steve.
Thank you our next question or comment comes from the line of Anthony Petrone from Mizuho.
Your line is open.
Thanks, and congrats on a good quarter here.
A couple just on looking ahead to a D E and in the next month or so here.
Some what we should be expecting from mankind, a and then and then B just overall when we think about the discussion on G. L P ones.
Xanthic Mujawar OS from other products out there and just how that plays into timing for us.
Utilization of insulin in type two patients just can you maybe level set us there on what we should expect into <unk>.
And I'll have a follow up question.
Sure Anthony Great to hear from you and thank you for joining us today.
We just came out of Ace last week, which is the other diabetes conference every year and.
It was really nice to hear people like URL Hirsch Who's Rover now.
Now some stage that he personally is taking afrezza right that gave us a lot of prep moments, we've worked really hard with him and others over the years and finally see physicians living with type one starting to use a friendly after eight years on the market kind of gives us some good excitement and his experience was Wow right I think that's what equivalent stage and Thats part of a whole bunch of questions around how to use it to use.
A couple of pump when do you use it so I think we're starting to get in the in the context of conversation, which is really what's domestic for a president for many many years.
As we look to 88, we have one small presentation on the ABC trial, which was the pump switch trial.
I think that'll be a poster if I recall.
Are gonna be present, there, we're going to have lots of dinner events. One on one customer engagements I don't expect a large booth presence there we've kind of redistribute the investment at that dinner events at 101.
But otherwise.
Our presence at Ada I'll be there and I think it'll be quite a busy meeting we're going to focus on the nurse practitioners nurse educators.
Diabetes educators the rest of the year. Those are those are deeper focuses for us as we go forward.
Your question on <unk> is a good one which is we do know dlp's are only delaying insulin for type twos that much further out we already know from the time a patient needed influence to the time. They got it I think it was about a seven to 10 year delay based on history. So it probably is going to make that another year or two longer because what I'm hearing from customers is yes.
The <unk> work amazing, but they still need post prandial control and that's one of our main focus is whether it's vega or friends or you still need better postprandial control you need to cut those highs down if youre going to improve time in range, where the only insulin that really gets out that it works in the body. The data is showing at Ada and that data showed that of ATT D.
We worked 30 minutes faster than the current gold standard right, we reduced those highs substantially and so that's not going to change we have a nice competitive differentiated profile, how do we start to make customers understand that that's a big focus as we launch our inhaled III trial with 20 top centers in the U S. R. L.
Understanding the product the product profile, the dosing and ultimately what that means to a patient so yes.
GOP will do great.
Drugs.
I think there'll be study, we're looking at maybe an investigators trial, how do we use <unk> plus a present right. That's probably the areas. We want to try to help patients who have suffered highs to bring their mealtime deal. It's all bad.
<unk> bring some clarity.
Telephone a quick follow up but just beyond.
The Blue Hal launch with Dex Com CGM, just to clarify I'm, assuming that would be with with <unk> seven and maybe just thoughts on on how that can trend starting in <unk>.
And when you think about utilization with CGM.
Is there a potential that we could see a collaboration also with with Abbott for that product. Thanks.
Yep.
Look I think when you look at where diabetes is going it's finally getting easier never going to be easy for patients, but do you think about once weekly basal once weekly gop's inhaled insulin, we're starting to get to really a differentiated place in life, where someone's not sticking their fingers are not sticking their scans are not having to worry insulin pumps.
Every day.
It's really exciting when we look out over the next 12 months.
In the context of Blue Hills, one of the things. We're excited about is we're probably going to have our own digital platform, where we integrate CGM along with the dosing of our president your inhalation effort and starting to show you what's happening real time, and then you can download those reports and send them to your doctor So that the beta testing right now.
Kind of get through the next eight to 10 weeks to make sure. It's all tight and Youre right. Its currently with <unk> <unk> seven.
And we would fully expect habit to allow us to have libre API at some point in the future we're not there yet.
In discussions with them I expect that we will get there. It's just probably won't happen at the same time frame as desktop, but yeah, we're going to use the blue here hopefully in the trial and collecting some of the data real time.
Showing what value we can bring to patients.
That's helpful. Thank you congrats again.
Thank you Anthony.
Thank you. Our next question or comment comes from the line of or in Loopnet from H C. Wainwright Mr Live Matt Your line is now open.
Oh, sorry, operator can you hear me.
Yes, we hear you already.
Growing I was clear my throat.
I just wanted to follow up on a one on one you mentioned that's going to be at 24 months studies. So I know, there's no rush on that but I think on the last call you mentioned as we get into this year towards Q2, maybe we can get some more color on that study and design and expectations I'm wondering if youre able now to give us just even if it.
Just big picture you know what are you trying to accomplish in that study how are you trying to differentiate.
From existing treatments and how do you imagine if you see what you want to see a 101 differentiating in the marketplace.
And I guess.
I guess longer term, how you think.
Uh huh.
Market share.
Want to get specific but just where you think it differentiates from the existing market.
Yes, no. Thank you Arne for asking me on 101, I think it's we've got we've had a lot of research coming in with doctors that were doing in the U S and Japan specifically.
And I think the first thing on differentiation.
Turning out to be a real good competitive advantage is our 28 days of dosing. So we're planning to dose for 28 days straight stop for two months and then dose against so a patient is only going to need to dosing cycles when it that'd be wiser for two months straight.
We're continuing to work on the dry powder formulation that will be a lifecycle management play, but in terms of pure differentiation from the only currently available proved MTM treatment, we feel very good about that first step.
That's gonna be around Tolerability and so we believe we know <unk> is a well established agent out there people loved the product it's used globally through expanded access program from Novartis and so doctors know it and they know the challenges with it around drug accumulation Qt prolongation and accumulation.
Skin discoloration, we really do believe lowering the dose dramatically like we are in our formulation.
We will minimize or remove those types of concerns and that'll be one of the key pivot points, we want to understand the trial the.
The other parts will be looking at will be sputum conversion as well as quality of life. As we know those are important aspects for the F. D. A.
Less important outside U S, but more important for the U S and we'll collect that data.
Trial size is roughly 180 patients of comfortable sharing that at this point.
And we will study.
Our high and low dose of Clofazimine.
Versus the standard of care and so we're not we're just going to take people on general background therapy and randomize them.
And one other one.
Current protocol is going into the FDA that we've had multiple discussions with.
It's really exciting so anyway from the time that IND is approved we will be activating sites very shortly thereafter.
Clinical supply will be available at that time.
Talk studies going on for one year will also be ramping up so we'll be able to dose patients for a year and get chronic dosing in this trial. The primary endpoint will be six months.
I think that.
Overall product. We're excited we think it's going to serve a unique in this market and we are going after pretty much.
On TPG and not responding.
Earlier lines of treatment.
So is there a particular type of patient you're aiming for to recruit into the study in particular.
Oh, and if it works and you see what you want to see how much of a of a registration package do you think this one I guess at the phase two slash three do you think this study could.
Represent do you have to do another pivotal after that.
No because it's a 505 b on a repurpose drug we only need one pivotal trial, we're calling it a phase II three there's really not a stopgap I'll say from phase two to phase III, it's a continuous enrollment all the way through.
So from that perspective.
It's pretty straightforward.
As indicated that a single trial is appropriate probably the biggest part that we're working on is how do you show the correlation of quality of life to sputum conversion positive and negative and there is some data generated around the world that we're trying to make sure we analyze as we finalize the statistical design, which again doesn't have to.
Be done until the trial database blocks. So we have time.
That data generate that data present published that data that will be really important to the package at the end of the day.
But right now we're focused on getting the trial off the ground.
As soon as possible.
Sites are very interested we have inbound calls from sites asking to participate.
So we're excited and we think theres going to be.
I always feel like trials never go as planned they always take longer but so far we've had luck with ABC and he'll want and helps bring we've had a lot of inbound. So we feel pretty good that mannkind is doing good trials, we're getting more and more experience running these trials and we're learning how to take appropriate risks.
It is possible.
Alright, I appreciate the added color.
Thank you.
Thank you I'm showing no additional questions in the queue at this time I would like to turn the conference back over to Mr. Christophe you for any closing remarks.
Okay.
Thank you everyone for dialing in today, it's been a great quarter, we're only in the first quarter, which should be a phenomenal year for our employees, our shareholders and all of our stakeholders and ultimately the patients. We serve we have multiple avenues of growth.
An exciting time to be here, we're hiring great people, we're having higher and higher quality job applicants jobs are filling people, we're not leaving the company. It's just a great time to be here and we're very very excited about the patients who are helping the demand we're seeing on a base of the demand we're seeing on afrezza.
Early trends of V go in the pipeline, we're really firing on all cylinders. This year and it's been a long time to get to this point, but we see nothing but very positive momentum as we go into Q2 and beyond for this year next year and years to come. So thank you everybody I know, it's been a long bright for our shareholders, but you should finally start to see the fruits of all the labor that we've been investing in.
Over the years so thank you again.
Have a great week everyone.
Ladies and gentlemen, thank you for participating in today's conference. This concludes the program you may now disconnect everyone have a wonderful day.
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