Q2 2019 Earnings Call
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Yes.
17, UTI is progressing very nicely as we just completed the build out of our high potency area within our factory and the teams are now in the process of preparing commercial batches.
This program to move very quickly for the next stage of development, where we expect to bring in $37.5 million and milestone payments in the next 15 months.
Additionally, we received approval for Brazil in Q2.
And we expect to ship our first commercial supply in Q3 for an October launch.
We are very excited about our partnership there as well as India as we get ready to start the phase three trial.
And finally ambarellas working on preparing our file for submission in Australia.
In addition, our recent announcement with one drop is our first partnership to move Blue Hill forward as we think about ways to make it easier for people to manage their disease.
Our second pillar is around our UTI partnership as they have exclusivity on our platform for pulmonary hypertension.
And we anticipate we will identify other opportunities to work with them over the coming years. In addition to our own internal pipeline progress we will provide some greater detail on how we view. This move forward based on our recently completed landscape assessment. The good news is our larger scale, our large scale dry powder manufacturing and formulation capabilities continue to be unique in the industry and give us a competitive advantage.
The third pillar is our FDA approved product Afrezza, which is protected by our vast Pat before we have that now exceeds over 975 patents.
We have made strategic investments to help close the clinical gaps for afrezza, such as new time and range data with CGM dosing and hyperglycemia.
Over the last 24 months, we have updated our packaging pricing structure dosing recommendations.
Our ft label as well as removal of Rems program. As we go forward you can now see 80 standards of care have been updated to include a friend has unique attributes our pediatric cohort two is almost complete and three opened up last week with top tier centers.
We also expect numerous new publications to continue to help build out the scientific story. In addition to our new data showing how well we can improved time in range, which we expect to become the next standard of care.
The good news is of Fred's is here to stay and help transform the standard of care for diabetes.
Our fourth and final pillar is our financial position, let me go to the next slide to talk about this.
As many of you have seen by now we have a summary of over seven transactions, we've been working on over the last month or two.
The first thing is the recapitalization create creates a solid financial foundation going forward.
Weve restructured over $200 million in liabilities to improve cash flow and capital structure.
We've reduced our legacy debt by approximately $28 million and the majority of our near term maturities, which were almost a $100 million. We're new in 2021 are now due in five years.
We just put a new current financing vehicle in place that provides almost $100 million and non dilutive capital. When you can when you add up to $75 million alone with mid cap plus United Therapeutics milestones.
This mid cap alone is broken into three segments $40 million up front as we've just taken with an option for $10 million by no later than April 15, 2020, and an additional option for $25 million. No later than 2021, assuming we meet the covenants in the agreement.
Additionally, we have reduced our cash burn when you look at our insulin purchase commitment that existed historically these without aligned within our current demand. We've now been able to work with ample start to get a more reasonable forecast and purchase commitment over the next four years, reducing our expense by $45 million.
We have also driven efficiencies and reduced spending throughout our business as you look year over year continued expense reductions and as we look into 2020 .
All of these choices that we've made are expected to fund the cash comp the company to cash flow breakeven.
My goal has always been to put this company on a path to cash flow breakeven now that we've completed this transaction when combined with the continued reduction our expense base as well as treasury moving forward I believe we now have the flexibility and opportunity to make this happen unless of course, we find investment opportunities.
That create greater value for shareholders.
The team at mid cap have done extensive due diligence on the management team Afrezza and the prospects for the company as we go forward mid cap manages a large debt portfolio with extensive healthcare experience backed by the Apollo group and we are excited to be partnering with them.
As you can see on this slide they have a vast experience in biopharmaceuticals healthcare and they really understand our business and our strategy and have followed the company for a long time.
They have brought accesses the funding through the partnership with Apollo Group and currently are managing over $20 billion and commitments.
Now, let me turn our focus to Q2.
First is international partnerships, we just discussed and the second is Australia, which I also mentioned the United Therapeutics is going very nicely, we expect to start the phase III trial very shortly.
The high potency manufacturing area is complete and built out we anticipate achieving our second milestone of $12.5 million in the second half of 2019.
The research agreement for the undisclosed page compound is substantially complete we expect a decision with United Therapeutics in Q2 three.
On insulin and mankind awareness you. Many of you have seen our Indianapolis 500 sponsorship with Conor daily as well as our friends for life as we go into the pediatric space.
We also are trying to change the conversation with print ads that you'll see in a second.
In one aspect as well as in held in Llanfyllin website, social medium Billboards that we just launched this past week.
And finally, we've increased our analyst coverage to four with BTG initiating in May.
The first thing I want to share with you the excitement thats going on in Brazil. Since the date of announcement of approval. It's been very exciting down there. We have appeared on the front page of the two big newspapers and has been lots of write offs by the way the physician community down there over 60 appearances have happened and Theres just a lot of build up there and so we're looking forward to working with them and make this a very very successful launch where we can take the learnings from the us and launched successfully in Brazil. The first time.
The second Big thing many of you may have seen in the past week is to targeting messages that we're and we're working on in Texas around spread the word say goodbye to mealtime insulin stigmata needles for your meal time insulin visit and held landfill dot com and everybody knows somebody with diabetes totaling about in Helmand from Dot Com. This is targeted in a couple of cities right now, including an airport in the Midwest. So we're excited to see how this works and so far the early days of web site traffic and video shares et cetera have been going above expected.
The next agreement that we signed was one drop which was announced on Monday.
An important part of this aspect is it really starts to connect of Frezza into the connected care community. When we think about providing seamless integration of patients managing their disease on third party platforms. We expect one dropped to be the first of other many platforms. We go forward with in the coming years. This will make it as seamless experience for when a patient takes their afrezza. The dosing will show up in the one presence into one drop app and when you look at your glucose data they are able to integrate dexcom as well as their own BGM data patients. We also see an overlay of their glucose response curves and with that data ultimately will start to do predictive analytics.
The next slide here talks about the scientific communication. These are decisions that were made over one to two years ago. When David Campbell joined 18 months ago, where we started a couple of these trials we submitted the data from 17 and 18 and now you can see it just takes a while to get the scientific data moving but as we go forward, we see numerous publications coming to support afrezza at the various conferences.
Already in 2019, but as we go forward in the publications in the second half and new data generated in 2020 .
For those who may have missed one of the important datasets at Ada wanted to.
Almost 93% of people achieved anyone see less than eight.
And the time has been greater than 180 as reduced almost by 50%. These types of results are unheard of and very excited about continuing to make a friend of part of the standard of care.
Now I'm going to bridge to the pipeline.
We completed an external third party landscape assessment to give us some feedback on how our platform stacked up against other inhaled products, including nasal technologies.
We completed this assessment, we were convinced that amongst our peers out there are we have a platform that does differentiate itself ended these compounds are the right ones to continue to focus on.
When we look at the real way to create value. It's really licensing these products when they get the phase one a lot of questions I get our around when will these products get the phase one how long does it take and so the next slide really gives you some descriptions of of what this typically looks like for typical program.
So this is a sample development plan to show year, one in year, two and our various compounds are in the various phases between year, one and year too as we get to pre R&D, which you can see the decisions that we made back in December to move the pipeline forward take six to 12 months before you start to get the pre filing at for example, FPL is already done year. One of this project and we have to go back to the FDA to find a feasible population that we feel this product and working.
But we are very excited to now fund the pipeline and this is in our cash flow plan to get each of these molecules to at least phase one where we think we can create significant shareholder value.
Now I'm going to turn it over to Steve to walk us through our financials.
Thanks, Mike and good afternoon.
Im also very excited by the announcement of both our recapitalization as well as our second quarter results I'll be breaking my discussion into two sections. The first will be addressing our recap.
The second will be a review of second quarter in June year to date results, we'll be discussing select financial highlights and urge you to read the condensed consolidated financial statements and Mdna contained in our 10-Q, which was filed with the SEC. This afternoon.
In addition to Mike High level review, we issued an 8-K after the market close today, which provides details of a recapitalization.
Now, it's time to dig into some of those details.
Starting with the graph on the left we entered the third quarter of 2019 with $108 million in debt.
Since then we executed four debt transactions over the last 30 days to reduce our debt by approximately $28 million, while pushing out our 100 million dollar 2021 debt maturity overhang.
And we brought in Midcap financial with initial $40 million funding, which puts our total debt outstanding post these transactions at approximately $120 million.
As Mike said earlier mid cap financial as a firm with deep roots and experience in lending in the life Sciences industry, who have done extensive research on our company performed lending money to us.
We feel really good about our partnership with Midcap and the support we have received so far.
So looking at the Big picture, we have increased cash by $30 million.
While increasing debt by only $12 million and have pushed out debt maturities to better align with future increased operational cash flows.
There are a lot of moving parts, which are more fully described in our 8-K's and we will answer questions in queue in a at the end of our presentation to help understand the numerous transactions we have empty have entered into.
Now a little bit more in the mid cap funding.
The total funding commitment is $75 million with two more trenches that we funded based on mankind, attaining milestones related to our commercial strategy.
The funding is at our option and we expect the second tranche to be $10 million after attaining our milestone by the end of the first quarter 2020, and $25 million by June Thirtyth of 2021.
The transactions associated with our legacy borrowings so at $28.4 million reduction in debt, which consisted of one $9 million repaid to Deerfield between two transactions, a previously announced repayment in July of $4 million and yesterday, we repaid the remaining $5 million. So Deerfield is now paid off and to release their liens on our assets and has released the $5 million held in escrow.
Second.
And $8.4 million reduction in the senior convertible notes consisting of repayment of $6 million and their principal reduction in the form of a discount for early payment of $2.4 million.
Leaving 5.3 million now due in 2020, and a $5 million convertible note due in 2020 four.
And third and $11 million reduction in the man group convertible note and accrued interest with the restructuring of the remaining $70 million debt into a $30 million convertible notes due 2024, and a $35 million term loan due 2024.
The debt reductions included the use of cash mankind stock in a discount on debt. So when you roll that recap transactions together, including the repurchase of warrants announced in July the restructuring of our legacy debt and the establishment of a new debt facility. We increased shares outstanding plus shares reserved for issuance by only 5.2 million shares or less than 2% of outstanding unreserved shares.
In addition to the new funding, we are committed to reducing spending from historical levels to enable us to achieve cash flow breakeven.
We have been reducing operating expenses year over year as you highlighted in our press release, and 10-Q and which are shown in the top table on the slide we plan to reduce spending further as we move into 2020.
Moving to the table on the bottom of the slide as highlighted in our 8-K filed today, we restructured our insulin purchase agreement to reduce our insulin purchase commitments by $46 million from 2019 through 2023 exclusive of the $2.75 million fee that will be paid partly in the third and partly in the fourth quarters of 2019.
We also extended the agreement by two years, which will better align our short term and long term insulin purchase commitment with patient demand for afrezza.
In addition to the spending reductions just discussed we have a number of different sources and potential sources of cash inflows looking out over the next 18 months, we expect to see over $110 million coming in from the United Therapeutics and Midcap, assuming we exercise our option on mid cap chances two and three.
We also have additional on potential sources of cash inflows that come from increasing use of Afrezza sales international presence sales, including possible new territories warrants exercised before expiration in December 2019, royalties from United Therapeutics from sales of trip.
The monetization of Trinity royalties, and new business development deals for both of Afrezza and our development pipeline.
Taking into account the full recapitalization of paying off and restructuring deck, our legacy debt, providing I'm, sorry, bringing in new funding, reducing our near term spending including our insulin purchase commitment.
And understanding our sources of potential sources of cash you can hopefully see how our business is expected to be funded to cash flow breakeven.
Now moving to operational results.
Starting with the table on the left total revenues for the second quarter were 15 million versus $3.9 million for the corresponding second quarter of 2018.
The 285% increase comes from both the recognition of revenue related to the United Therapeutics for license and research agreements of $8.8 million as well as growth of 62% and a further net revenue to $6.1 million for the second quarter of 2019.
Inception to date, we have recognized $21.8 million for United Therapeutics license agreement and $9.5 million from United Therapeutics Research agreement, where performance obligations are substantially complete.
The Afrezza net revenue increase is favorable impacted by volume cartridge mix and price and this is a similar storage prior quarters. Please note that we did not experience a significant wholesaler inventory change in the second quarter like we saw in the first quarter, which negatively impacted our Q1 afrezza revenues.
Moving to the June year to date revenues in the rate table total revenues were $32.5 million versus $7.4 million for the corresponding six months of 2018.
The 341% increase comes from both the recognition of revenue related to the United Therapeutics license and research agreements of $21.1 million as well as growth of 56% in Afrezza net revenue to $11.1 million for the June year to date period. There further net revenue increase is favorably impacted by volume cartridge mix and price and affected gross to nets of 40% were similar to 2018.
As just mentioned our second quarter further revenue growth was favorably impacted by cartridge mix.
We grew our eight new and Twoku cartridges more quickly than the four new cartridge, which has a profound impact on revenue growth as our eight you is priced at two times before you and our 12 you as price of three times before you.
You can also see the total cartridges grew more quickly a 39% than trx, which grew at 28%, which reflects the impact of increasing 180 count box versus 90 account box prescriptions being filled.
Addressing a phrase that gross profit for the quarter. The table on the left hand side of this slide shows the second quarter of 2019 with the third consecutive quarter that we have had a gross profit for afrezza. Our net revenue increased in our cost of goods sold decreased in the second quarter of 2018, producing our gross profit of $1.7 million for the second quarter 2019, and a gross margin of 28.7%.
We continue to have excess capacity cost being recorded in cost of goods sold which are not capitalized into inventory due to the under utilization of our factory and manufacturing related personnel. The table to the right shows our June year to date of Fred's gross profit of $2.8 million and a favorable change of 4.7 million from the first half of 2018, when we had a gross loss for the same reasons as just discussed.
Our friends at gross margin for the last three quarters, which are the quarters. When we had a gross profit are shown at the bottom of the slide.
Gross margin has increased from 12.9% in the fourth quarter of 2018 to 28.7 in the second quarter of 2019, we expect sales increased to outpace cost of good increases in the near term as excess capacity costs are absorbed into inventory, which should produce increasing gross profit as revenues increase.
Thank you and now I will turn it back over to Mike for additional comments.
Thank you Steve Nice work.
So when we look at Afrezza, we really strive to simplify diabetes treatment. So if you look at the top of this pyramid. Our first goal obviously is to continue to grow and accelerate afrezzas growth. Additionally, we've tried many different things over the past couple of years and as you look forward, we're going to do less and placed targeted bets, it's really about executing with what we have and continuing to balance the cash in the company with the expectations of revenue.
We're going to paraphrase what CGM as you saw our first deal today with.
One drop, but we think thats exciting given where they are with in integrating dexcom into their platform.
We're going to remove and reduce payer hurdles as we go forward and expect to have continued positive news in this in this segment as we go forward.
When you look at these four underlying pillars, it's about driving consumer demand, which we're currently doing in the Billboard in online campaign, removing friction along the journey, which is really around the excess copay card program. We launched this year as well as reduction of prior authorizations are minimization of prior authorizations.
And payers are going to build partnerships with third parties around the CGM JDRF Ada.
80, as well as ace.
And we're going to continue to focus on enhancing the salesforce capabilities. We've recently taken about half of our salesforce through tier two training, which is really help close the gap and bring them from the middle to the top of performance.
Now when I look at a friend's the growth over the last three years between and each quarter. You can see we've had a fourx revenue whether you're looking at gross revenue net revenue by the quarter or by the half and we continue to expect afrezza to grow for years to come it's really nice to see the choices. We've made the investments we've made continued to pay off quarter over quarter year over year.
And finally I wanted to show you a good historical perspective based on the Symphony fast data from when we launched our Salesforce in Q1 of 17 looking at refills, continuing to build and our access continues to grow and revenue as a result of our strategy continues to grow quarter over quarter with a consistent decline in Q1 versus Q4 and continued growth. The following quarters. There is nothing in this trend that we don't expect to continue and we're very excited as we continue to move the company forward in the coming year.
And then finally, just want to talk about some key milestones as we close out the quarter. We've hit many of the ones, we've laid out and expect to hit the remaining five or six on the slide.
Core two is really a couple of patients away from completion.
Formulation work is substantially done we'll meet with United and decide next steps there are Brazil launch I will be there in the coming months and excited to meet with the team down there and the doctors.
We are initiating our clinical study in India and currently building the supplies.
Another study many people aren't watching yet called kipnis switches and type two using dexcom CGM with a fixed dose titration and again this will be a bigger study than than the one. We did was filled recently presented filled within data on that we expect to see really good outcomes as the study completes enrollment and gets presented next year.
And finally as the slide that we all know is recapitalization is now complete and I am excited to lead the company forward without focusing on raising money and getting us and right now I'm going to focus on getting us new investors to continue to build our investor base as we go forward and executing our plans that we've laid out over the next five years. Thank you everyone I think we'll take questions.
Thank you if you would like to ask a question. Please signal by pressing star one on your telephone keypad. If you are using a speaker phone. Please make sure. Your mute function is turned off to allow your signal to reach your equipment again press star one to ask a question well pause for just a moment to allow everyone an opportunity to signal for questions.
We will now take our first question from Pasha Sourav of SVB Leerink. Please go ahead.
Hi, This is Dan Dupree sitting in for Pasha, two questions for you number one.
Just to kind of look further down the road the pediatric study.
What steps are going to be next required next after the the current cohort three finishes enrollment.
And in order to get label expansion and then a second question just on other initiatives such as with Kaiser Health.
How should we be thinking about selling interactions with these groups the growth opportunity there and how that compared to other key targets such as these are the centers of excellence that you're actually making a priority. Thank you.
Sure I like doing a first on the pediatric so cohort three is really the cohort recorded a seven year old. We are just really open up another site. So this quarter three hopefully will go.
As planned and we can wrap up the study in the meantime, we're planning to go to the FDA to wrap up the data we have so far and get alignment on the phase three protocol and then depending on how things are in and post the meeting will decide how to progress this into the phase three segment.
But that's the first step the second step here is continuing to meet with pediatricians and understand how big of an opportunity. The pediatric segment can be and then from there we'll quarterly worked through the funding plans that we that we have for it.
The second one is around Kaiser So Kaiser is really starting from from ground negative I'll say, meaning it's a closed system and they have no exposure to appraise other than a handful of patients who were there and we have a dedicated person working up and down the channel Kaiser really starting to make inroads in fact, some of our employees because Kaiser is one of our own health insurers are going to Kaiser for their own health benefits in the first meeting there was they didn't even know what afrezza was and so I think when you think about impacting all their endocrinologist, it's going to take a little bit of time, but when you look at what Kaiser's publishing it's around.
$100 million and expense around hypoglycemia.
And they really are focused on how do they continue to reduce hyperglycemia rates on their system and get better outcomes and so that remember they use humulin still as their primary insulin of choice. So so we really think we have a good value proposition for Kaiser as it goes forward, but it's not going to happen tomorrow, but we do have a five year contract and are excited to continue to work with them to change change hopefully the whole standard of care there.
The following one is just around other access contract. So we continue to show.
For example, the top 25 docs, who adopted a frezza went from 100 scripts two years ago to over 500 scripts in the last quarter, we continue to see.
As we get people onboard and they adopt the drug they continue to grow and the question is how do we keep getting the next group of physicians in the next group of physicians.
And increased depth of prescribing and so with that that's one of our core focuses and the med D contracts come and are just now coming in terms of what were the results are for contracting for 2020 and at this point, we're cautiously optimistic and excited that we'll see some good changes in our med D access as we come into Q3 and get ready for 2020.
So I hope that answers that the three questions.
Excellent.
Thank you.
If you find that your question's been answered you may remove yourself from the queue by pressing star team. Once again, if youd like to ask a question. Please signal by pressing star one we will now take our next question from Anita Dushyanth of Zacks small cap research. Please go ahead.
Anita.
Are you on mute.
Hello can you hear me, Okay, alright, well now we can hear you, yes, hi, [laughter]. Thank you congrats on the quarter and thank you for taking my question.
I wanted to know what is sort of person does grow do you expect to end the prescriber good progress going forward and also do you plan to turn on the DTT Dpcs for Afrezza during the rest of the year.
[noise] no I don't think we've given guidance on prescriber growth, we continue to see prescribers grow quarter over quarter or we look at our new co pay card data, we see that growing month over month. So overall there is nothing change we expect to continue to gain new prescribers, given our sales force footprint.
I think what's important is we started the year with about 55 sales reps in the field. We have hired about 20 I think right now we've got two or three openings. So we're roughly fully staffed.
At almost 75 people and a lot of those people just cannot train in the last quarter. So they get the launches and plans with their doctors. We know it takes three to six months for them to start to make impact.
So we're optimistic in the second half that we'll see more and more prescribers adopting the product and trying the product as weve. Those territories are now filled since January .
The.
The second question there was DTC so on that one I think given the lack of response that we saw in the investment that it took.
At this point I would say, we see more impact from the Billboards we launched in the first week and if anything we will scale that one up before we scale up TV, it's a very expensive proposition.
And I think the second part of that would be we probably would make a new commercial disappoint.
Before funding that commercial but im just as we look forward DTC is not in our current cash flow were spends and it's not something we expect to bring forward in the near term.
Great. Thank you for that I find that and you said the offense or distribution and breeze in Brazil, the launch will be in Q3.
When do we sort of expect to should we expect the shiffman for Australia.
It'd be sometime next year.
For Brazil, you should expect a shipment in Q3 for Australia. We expect we're working on the filing now so thats going to take.
A little bit of time down there so I want to give guidance yet as we havent yet filed the.
Application for Australia.
Okay, and just a last one more question could you provide some clarity on the pipeline related to our lives.
Good movement, then do you have any update on that.
Oh, I don't want to speak for all of US I know, they're working on quite a few things and you know they continue to be a great partner and move move that product category forward. There's obviously a lot of state and federal laws and country law, they have to get through but I think that market continues to evolve and our technology is differentiated within that that market.
So I want to speak for a less but I think they'll continue to have news coming out in the second half.
Great. Thank you like that will be it from me. Thank you.
Okay.
We will now take our next question from Robert Hazlett of BTI Ji. Please go ahead.
Hi, guys.
This is Jay garner for Bert.
Okay.
Okay.
Well I'm glad to hear you.
Okay. Good Yeah I was just wondering if you guys could comment on your progress with.
Type one patients.
Yeah.
I think in the type one segment in particular, you know that's an area that we're going to continue to focus more and more on they make up about 40, 40% to 45% of all insulin use in the country and I'll mealtime.
But when you think about our product and CGM adoption, it's an ideal platform for type one.
One of the challenge I know we've seen in this in the historical.
Uptake into type ones as they view that more as an add on either to make their pump work more effectively or to tap aldehydes stubborn high although they were experiencing so I think the real question is how do we continue to to drive.
Fundamental adoption as a real true mealtime insulin a full time as opposed to this headwind concept that we've seen and some of that's.
How was adopted in California, that's driven that I know, we have a lot of pumps used in California, but we really do believe type ones, we see them everyday working for us all that they have a phenomenal experience with the frozen they got phenomenal timing ranges and I think it's just how do we continue to get that out there and I think that's really the goal is starting to utilize the unique aspects of Afrezzas PK PD shown you that all almost real time feedback that you see on CGM with the frozen on the part of the.
And how many insulin campaign, where you kind of see the real world perspective of someone having to wait two injector insulin and I think that's that's our main focus is how do we continue to bring this into the lifestyles of people that they can live in a spontaneous moment.
And so that's one area, we continue to look at other other ways to penetrate the type one market.
I work with the top thought leaders as well and looking at one investigator initiated trials that we think will help differentiate the product.
In that segment. So it's a big focus for US is the short answer.
Got it that makes sense and then you guys also mentioned expectations for numerous new publications I was wondering if you could provide additional color on what you expect to convey in these publications.
Yes.
Just a hunger for back to the slide real quick.
So if you look in the real big focus for US is continuing to build out the scientific story around the ultra acting aspects of the product. So we think thats important to get this data published because we believe at some point between the Ace and the AIDEA guideline that there will be an all direct and category and getting our data published to highlight the PK PD profile of our product is one of those things that will be important for them to build a reference to when they create that category.
I think the other aspects of the products are really around time and range and hyperglycemia and showing you the dosing and so there's a whole host of publications around that and then finally, it's really around pulmonary safety in helping people understand the data we do have a pulmonary and what's been studied historically and Fortunately Pfizer just published a data from 2012 recently showing you. The inhaled insulin is relatively safe and effective and I think thats all the scientific data continues to support the efficacy safety balance of this product in this category of treatment as we continue to grow.
Great and thank you if I can just ask one more I'm just wondering if you could kind of talk about the response prescriber you've gone from prescribers based on the 88 data you presented specifically around the more simple tightrail, one regimen and the need to get on higher doses.
Yeah.
I think I wanted another couple of time since I did it came out and with customers, but I think the general feedback from customers is this man the ones who use it the feedback is that matches their clinical experience and reinforces our confidence in the ones who haven't used it it helps them understand what they need to get to and for example, we just look back at one of our pharmacy students just presented information from our 2006 trial.
And in the type two segment there, we actually kept the dose to roughly eight units of injecting relatively units of Afrezza.
Well the average dose in here in this trial you can see people got the 16 to 20.
Units per meal and so so it just shows you how far we've come in understanding the dosing of the product and what's required to truly get a nice response output and I think thats.
People Miss understand trying to compare an injectable to an inhaled and they really are different and I think thats what were trying to explain to people is don't don't look oh compare in an Apple and an orange really look at them as two different products to different ways. They work.
Fundamentally indicated for mealtime control and I think that's that's where you'll start to see is a summary of our data going forward and that don't don't mix up the units really look at this as a unique option and a fixed dose way that helps you get type twos, especially under control without a lot of complexities.
So that's our goal there and we're implementing that protocol and India too. So I think that's that's policy, partly what that study is very helpful. For us all the new trials, we have that should be a protocol pretty consistent that we go forward with.
Okay, great. Thank you and congratulations on all the progress.
Thank you.
Okay.
Well here's your thank you everyone.
I'd like to turn the conference back to you.
The closing remarks.
Now I want to say thank you everyone were very excited about the second half in 2020 and beyond.
It took us a little bit longer than we wanted to to finish up the recapitalization, but we want to make sure as we signed up for.
Covenants and partnerships and people in the partner, we work with them on that that it was the right timing and we really do feel the company is at a place where this was the right time with Deerfield, ending and starting with a new partner and that we can hopefully minimize any dilution going forward. So that we can continue to run the company at the stock price respond appropriately and continue to grow frezza within the U.S. and outside the U.S. In addition to move into possible forward as well as our pipeline. So thank you again for everyone. Thank you for the Mannkind team working behind the scenes. There was a lot of effort and a lot of late nights getting here, but we made it happen and that just thank you to everyone around us and all the support.
That said before to keeping in touch and well have a few comments.
Updates in September at some of the healthcare conferences, So we'll talk them.
Thank you.
This concludes today's call. Thank you for your participation you may now disconnect.