MannKind Corporation Participation at Upcoming Conferences
Sept 11, 2023 11:44:19 GMT -5
liane, BD, and 27 more like this
Post by MnkdWASmyRtrmntPlan on Sept 11, 2023 11:44:19 GMT -5
Summary of Oren and Mike's talk:
Last qtr UTHR reported a blow-out results that included a $30 million inventory number that DPI is clearly driving that whole franchise now.
Mike said the launch went really, really well. In April they doubled the capacity they had within the current framework that they had, which gave them a great quarter. They are also building a large $60 million expansion in Danbury right now.
Right now Tyvaso is a little over $300 million/qtr ($30 million per week). So if the product ships on a Thursday instead of a Monday, that could change the $30 million, so I wouldn't read too much into that $30 million is my whole point.
Next year United will finish up their IPF studies. They're building up their additional mfg capacity.
Oren: UTHR doesn't break out this specific product from the franchise. I think this is probably running at about $600 million annually for DPI alone just a year into launch, which is pretty spectacular.
Mike: Patients are having great experience with DPI. The conversion is about at the end, and it's all about the new patients now.
Tyvaso used to lose as many people as they gained. Now, people are staying on the drug. They don't have as much tolerability issues and the base is building up, and then they also got the ILD indications.
Mike: traditionally, tyvaso was nebulized, which is covered under part B. DPI is covered under part D. So, there was this gap of insurance coverage between Medicare parts B & D. That window closes next year a little bit, and then in 2025 it closes pretty much for (all?), it will be about $1,500/year. So, out of pocket costs will be capped, whereas last year it was like $10k (it was like a lot of money). There is a portion of Tyvaso that is the Patients Assistance program. A lot of that is probably in Medicare and then over time that will go back to paid Rx's.
Oren: In your call you said that for every 10k patients on T DPI, that added $250 to 300 Million/year.
Mike: for the next 12-18 months I can see the current patients are going to continue to improve. Then, you've got the IPF readout. IPF will be the next big leg-up, and really, they are IT. In IPF, a lot of things have failed. All the early data says it works, so if that works, that's going to be a huge expansion to our revenue in our patient population. That;'s why we're building our mfg expansion now.
So, IPF is the big opportunity. Then you got international expansion. Teton.
We're trying to get the Insulin business to breakeven into profitability next year. Its been a big drag for the last 20 years. We'll start to see 2 new data readouts that should be positive (hopefully). This year we had a big win on Medicare part D. Inhaled is now $35 and anything else is covered by the government. And, commercially, we (got?) it down to $35. And if people really don't get covered for whatever reason, it's like $100 cash. So, we've solved the reimbursement access. That's been the number one objection on the brand. The second one is Lung. Well, after 9 years on the market, we don't see anything.
What investors don't realize is that we've starved the inline commercial product to pay for the pipeline. The pipeline is what will give the company the 10-X opportunities, and that's why we made those funding trade-offs. We'll never get a one-to-one tradeoff for funding (of Afrezza vs. pipeline) until we get those until the new data comes out next year. The pipeline is the most undervalued (or, unvalued) part of the company today.
MNKD 101 (nebulized clofazimine). We'll focus on the (mac?) population plus the coinfection population. We're ready for a Q2 launch in the trial. We expect a 13-15 month enrollment timeframe in about 70 sites around the world. This will be a trial that's used for Japan as much as US approval. Nebulized has a lot of side-effects. A lot of coughs. In our case, it's 28 days of dosing, and then you're off for 56 days, and then you dose again. So, your dosing is cut by 75%, which helps patient convenience and tolerability.
Mike: we know this product works. It's really just getting it thru the trial. Up to 20 days it looks good. We don't expect to see anything (problems).
Our market data research indicates that the fast uptake will come from (?), and then from anyone that is intolerant. Mike believes Clofazimine is going to show a real benefit to the population, and the clinical profile (efficacy, tolerability) are going to be far better than what patients have today. Clofazimine can be used as a mono-therapy as well as a synergistic combination therapy, so its very versatile product. We will get it to market as fast as possible, and then continue to improve the product profile over time.
Nintedanib oral and clofazimine have done a great job for IPF. We have been working on the inhalable version for a number of years now. A lot of things have failed in IPF. UTHR has a drug. (another company?) has 2 drugs which both get 50% severe GI toxicity. So, even if our oral and inhaled nintedanib is going after (50 or 15?%) of the market, that’s still a multi-billion dollar opportunity. And then Bristol Meyers has a drug that they are still in the early stages of development, and us. So we have Tyvaso, Nintedanib and TGF-b shots on IPF. In the coming months, you will see that MNKD is an IPF company.
We are now in control of our own destiny. We will start to de-leverage the company a little bit. We will continue to fund our innovation in our pipeline. Afrezza and VGo should keep growing. Tyvaso looks good as far as we can see (into the future). We look to be a very nice growth engine into the next foreseeable future, but I don’t want to give guidance yet. And the pipeline should really come into (?) for patients, shareholders, doctors. Pulmonologists will see the same platform, inhalers and success in IPF, etc. We have lots of cash to continue to run our future and we feel that we don’t have any major needs for more capital to fund what we need to fund to grow our company.
Next year will have 2 readouts on Afrezza, and that will decide whether we can grow Afrezza faster than we have historically and are we willing to spend more capital to do that. We’ll make those calls once we see the data. The pipeline is in our funding forecast. We’re paying down our debt. We have done small deals on M&A and we will continue to look for things, but we have enough work to do on our hands, so we don’t need M&A to survive and it would be more of a distraction than a benefit. If we see something of interest, we’re not against it, but we feel very good about our future and capital allocation, which is to continue to invest in our growth brands, our pipelines and to pay down debt.
Oren: do you expect more competition?
Mike: Competition is a good thing. The other technologies are very different. They need much more drug for the same effect. We have the leading edge and are ahead of the competition.
Last qtr UTHR reported a blow-out results that included a $30 million inventory number that DPI is clearly driving that whole franchise now.
Mike said the launch went really, really well. In April they doubled the capacity they had within the current framework that they had, which gave them a great quarter. They are also building a large $60 million expansion in Danbury right now.
Right now Tyvaso is a little over $300 million/qtr ($30 million per week). So if the product ships on a Thursday instead of a Monday, that could change the $30 million, so I wouldn't read too much into that $30 million is my whole point.
Next year United will finish up their IPF studies. They're building up their additional mfg capacity.
Oren: UTHR doesn't break out this specific product from the franchise. I think this is probably running at about $600 million annually for DPI alone just a year into launch, which is pretty spectacular.
Mike: Patients are having great experience with DPI. The conversion is about at the end, and it's all about the new patients now.
Tyvaso used to lose as many people as they gained. Now, people are staying on the drug. They don't have as much tolerability issues and the base is building up, and then they also got the ILD indications.
Mike: traditionally, tyvaso was nebulized, which is covered under part B. DPI is covered under part D. So, there was this gap of insurance coverage between Medicare parts B & D. That window closes next year a little bit, and then in 2025 it closes pretty much for (all?), it will be about $1,500/year. So, out of pocket costs will be capped, whereas last year it was like $10k (it was like a lot of money). There is a portion of Tyvaso that is the Patients Assistance program. A lot of that is probably in Medicare and then over time that will go back to paid Rx's.
Oren: In your call you said that for every 10k patients on T DPI, that added $250 to 300 Million/year.
Mike: for the next 12-18 months I can see the current patients are going to continue to improve. Then, you've got the IPF readout. IPF will be the next big leg-up, and really, they are IT. In IPF, a lot of things have failed. All the early data says it works, so if that works, that's going to be a huge expansion to our revenue in our patient population. That;'s why we're building our mfg expansion now.
So, IPF is the big opportunity. Then you got international expansion. Teton.
We're trying to get the Insulin business to breakeven into profitability next year. Its been a big drag for the last 20 years. We'll start to see 2 new data readouts that should be positive (hopefully). This year we had a big win on Medicare part D. Inhaled is now $35 and anything else is covered by the government. And, commercially, we (got?) it down to $35. And if people really don't get covered for whatever reason, it's like $100 cash. So, we've solved the reimbursement access. That's been the number one objection on the brand. The second one is Lung. Well, after 9 years on the market, we don't see anything.
What investors don't realize is that we've starved the inline commercial product to pay for the pipeline. The pipeline is what will give the company the 10-X opportunities, and that's why we made those funding trade-offs. We'll never get a one-to-one tradeoff for funding (of Afrezza vs. pipeline) until we get those until the new data comes out next year. The pipeline is the most undervalued (or, unvalued) part of the company today.
MNKD 101 (nebulized clofazimine). We'll focus on the (mac?) population plus the coinfection population. We're ready for a Q2 launch in the trial. We expect a 13-15 month enrollment timeframe in about 70 sites around the world. This will be a trial that's used for Japan as much as US approval. Nebulized has a lot of side-effects. A lot of coughs. In our case, it's 28 days of dosing, and then you're off for 56 days, and then you dose again. So, your dosing is cut by 75%, which helps patient convenience and tolerability.
Mike: we know this product works. It's really just getting it thru the trial. Up to 20 days it looks good. We don't expect to see anything (problems).
Our market data research indicates that the fast uptake will come from (?), and then from anyone that is intolerant. Mike believes Clofazimine is going to show a real benefit to the population, and the clinical profile (efficacy, tolerability) are going to be far better than what patients have today. Clofazimine can be used as a mono-therapy as well as a synergistic combination therapy, so its very versatile product. We will get it to market as fast as possible, and then continue to improve the product profile over time.
Nintedanib oral and clofazimine have done a great job for IPF. We have been working on the inhalable version for a number of years now. A lot of things have failed in IPF. UTHR has a drug. (another company?) has 2 drugs which both get 50% severe GI toxicity. So, even if our oral and inhaled nintedanib is going after (50 or 15?%) of the market, that’s still a multi-billion dollar opportunity. And then Bristol Meyers has a drug that they are still in the early stages of development, and us. So we have Tyvaso, Nintedanib and TGF-b shots on IPF. In the coming months, you will see that MNKD is an IPF company.
We are now in control of our own destiny. We will start to de-leverage the company a little bit. We will continue to fund our innovation in our pipeline. Afrezza and VGo should keep growing. Tyvaso looks good as far as we can see (into the future). We look to be a very nice growth engine into the next foreseeable future, but I don’t want to give guidance yet. And the pipeline should really come into (?) for patients, shareholders, doctors. Pulmonologists will see the same platform, inhalers and success in IPF, etc. We have lots of cash to continue to run our future and we feel that we don’t have any major needs for more capital to fund what we need to fund to grow our company.
Next year will have 2 readouts on Afrezza, and that will decide whether we can grow Afrezza faster than we have historically and are we willing to spend more capital to do that. We’ll make those calls once we see the data. The pipeline is in our funding forecast. We’re paying down our debt. We have done small deals on M&A and we will continue to look for things, but we have enough work to do on our hands, so we don’t need M&A to survive and it would be more of a distraction than a benefit. If we see something of interest, we’re not against it, but we feel very good about our future and capital allocation, which is to continue to invest in our growth brands, our pipelines and to pay down debt.
Oren: do you expect more competition?
Mike: Competition is a good thing. The other technologies are very different. They need much more drug for the same effect. We have the leading edge and are ahead of the competition.
