MannKind: What Do Pfizer, Sanofi, And MannKind Have In Common?

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Where Do We Stand Today with MannKind Remaining a Viable Corporation?

What do Pfizer (PFE), the world’s largest drug company, Sanofi (SNY), a multi-billion-dollar drug company, Al Mann, and MannKind (MNKD) all have in common? I will share the answer with my readers after I lay the foundation for this burning question that MannKind investors should be asking and seeking the answer to.

Within just a few days a pivotal event will occur for MannKind, but will it matter? What I mean by this -will the FDA approve the dry powder formulation of the United Therapeutics (UTHR) treprostinil drug for treating the PAH condition for human patients? Simply – is the delivery of this drug via MannKind’s Technosphere system a viable option for patients?

Let me quickly go on record. It is my opinion the FDA will approve the United drug with their forthcoming decision. The real question is whether this makes a difference for MannKind’s viability as a going company. I don’t know the answer, however, there are signs and indications coming from MannKind that could be giving the discerning investor a harbinger of what is developing.

For nearly eight years, I have written about the shortcomings of MannKind’s Afrezza inhaled insulin product. Even when Sanofi signed on for marketing the product, I was one of the few naysayers for this not being a good deal and would not be a sustainable partnership. With this article, I will outline for those invested in this stock, it is my opinion the Technosphere delivery system is a flawed method for delivering insulin to a patient’s lungs. In my opinion, MannKind has finally publicly stated, and by public action, has shown that Afrezza and the Technosphere delivery system has internal and external flaws. Afrezza is insulin! Insulin has been proven to be a useful medical product for treating and remediating the diabetic condition that worldwide is an epidemic scourge on living entities. But MannKind’s Technosphere delivery system is proving not to be the product that will be the solution for this epidemic issue.

Now the question is one of whether we find out that treprostinil might suffer the same results as insulin did when dosed via MannKind’s Technosphere system. In the United States, there is more to the equation than just having a drug approved by the FDA for it being successful in the marketplace. The economic system here is predicated on a drug company making a profit with their product.

What Have the MannKind Executives Seen and Done To Save the Company?

The first thing seen is the dismal adoption of Afrezza by doctors and the ultimate decision of those who have tried Afrezza but opted to discontinue using the product. When Pfizer launched Exubera in 2006, within five quarters the product was generating $59.8 million in revenue – in the 1st Q quarter of 2007. With such results, Pfizer canceled their partnership with Nektar (NKTR) Furthermore, Novo Nordisk (NVO), Lilly( LLY), Sanofi, and several other small drug companies shut down their efforts to create an inhaled insulin product. Each of these companies deem that it wasn’t a viable product where they could make a profit. These companies had final Phase III trials ongoing. Only MannKind continued their effort where to date they have spent more than $3billion in creating and marketing an inhaled insulin product-Afrezza. And what have the results shown?

We know that Pfizer bailed out of Exubera where they had peak quarterly sales approaching nearly $60 million. Now into the eighth calendar year of trying to generate revenue from Afrezza, looking at annual revenues, MannKind has never come close to achieving the standard set by Pfizer in one quarter — $59.8 million.

Cumulative Yearly Prescriptions – Net Yearly Prescriptions, %Gain – Plus/Minus

Yearly Cum.

Year Net

%Gain

(+) (-)

2015

19,604

19,604

2016

35,371

15,767

-19.60%

-3,837

2017

52.988

17,617

11.70%

1,850

2018

80,622

27,634

56.80%

10,017

2019

116,023

35,401

28.10%

7,767

2020

155,972

39,949

12.80%

4,548

2021

192,251

36,279

-9.20%

-3,670

(Data Obtained by the Author from Symphony)

In 2015, seven years ago, Sanofi launched Afrezza into the market with a massive sales force and marketing group with proven capabilities for promoting a new drug in the marketplace. That first year of launch only involved 11 months of effort, not even a full year. Without having one patient using the drug and hardly any public knowledge of the drug, Sanofi achieved 19,604 prescriptions-new prescriptions and refills. Yet, Sanofi decided to drop their partnership with MannKind, who was so desperate to get a major drug company on board, they gave up worldwide rights to Sanofi for a mere $150 million in upfront money. And on top of this paltry amount, MannKind was on the hook to fund 35% of the marketing cost. This is what is known as a “sweetheart” deal-for Sanofi! I think I mentioned this in my first MannKind article way back in 2014. For those owning the stock when the Sanofi deal was announced, those shares today are worth about $0.75 cents, losing about 95% of their value in the interim.

But with reference to the above grid, with Sanofi out of the picture, there is no surprise that in the full year of 2016, investors saw a drop of prescriptions to 15,767-a decline of 3,837 prescriptions, or a net percentage drop of 19.60%.

Now looking at 2017, with a foundation of 35,371 prescriptions we see a yearly net gain of prescriptions hitting 17,717 total prescriptions, or a percentage gain of 11.70%. What is clear from this early stage of marketing, initial users of the product were not getting their prescriptions refilled.

And now we move to 2018 and look at the jump-27,634 prescriptions, 56.80% gain, based on a gain of 10,017 prescriptions. But this data is showing one concerning trend-three years of adding new patients where they should be getting refills at least every three months – but they were not getting them refilled.

Moving now to the fifth year of marketing, 2019, the data shows growth, but only a 28.10% growth, or a meager 7,767 in prescription growth. Still, the question remains concerning where are the refills for Afrezza?

Now we are into the sixth year (2020) of marketing and coming off a 28.10% gain from the previous year, the percentage gain dropped to 12.80%. Just with normal refills rolling over every 3 months, how could total prescriptions only grow by 4,548 prescriptions?

2021 results for the Symphony data have been recorded and seen, and we are waiting on the full-year financial results. But it takes only a quick glance to see that 2021 turned out to be a collapse of six long years of trying to successfully market Afrezza. After seven years of effort, the percentage of gain in prescriptions fell by 9.20% and actual prescriptions dropped by 3,670. This leaves only one assumption-new prescriptions and certainly refills have entered a collapsing status.

And now that we have results from the first six weeks of the eighth year on the market, the collapse rate in prescriptions might be increasing. The first six weeks of 2022 show that 3,979 prescriptions have been recorded by Symphony. On a sequential basis from the last six weeks of 2021, prescriptions were 4,397, or 418 fewer. Six weeks into 2022 and already total prescriptions have declined by 10%–why are the foundational original prescription patients not refilling their prescriptions? But more important-what is MannKind doing to stop this erosion?

Plus, one should keep in mind that it’s not only in the United States where the product cannot be successfully marketed. The only other place that Afrezza has been sold, is Brazil. But even in Brazil patients are not willing to purchase and use the product – there are no takers as indicated in MannKind’s SEC filings:

“In September 2019, the Company delivered its first shipment of Afrezza to Biomm and recorded it as net revenue – commercial product sales for $0.7 million, in advance of the planned launch of the product in Brazil by Biomm. During the second quarter of 2020, the Company sold $0.2 million of products to Biomm. No additional shipments were made to Biomm in 2020 or the first nine months of 2021.”

The Bombshell Announcement on February 17th, 2022

The answer for this quandary was given during the Q&A session on February 17th, at the SVB Leerink 2022 Global Healthcare Conference. When asked by the Leerink analyst about the marketing plans for Afrezza in 2022, the CEO dropped a bombshell of an answer. The CEO stated their plans involved cutting back on the marketing funding for Afrezza.

If MannKind investors had been paying attention, they could have seen this cutback was already in the cards. When MannKind filed their 3rd-Q, 2021, SEC report investors could have seen that MannKind had drastically canceled their lease vehicles for their sales representatives. If you are cutting your sales force for your only product, you don’t need as many cars as you have leased. Funding and maintaining a fleet of leased automobiles sitting unused in a storage facility is a bad waste of the limited funds that MannKind has available. I even mentioned this cancellation in my previous SA article – some might have ignored it and merely kept loading up on MannKind’s stock.

In addition, when asked by the Leerink facilitator about the pending FDA approval for United Therapeutics’ dry powder inhaler product, the CEO danced around giving any concrete answers concerning what the label for the product will say about what is demanded on all prescriptions. And talk about a mishmash of “fruit salad” words concerning competition and any future partnership deals with United – so many words of beating around the bush, IMO!

The other major clue about what MannKind has undertaken is selling off their one solid asset that Al Mann had the vision to seek and obtain at the beginning of the creation of the MannKind Corporation. This being real estate-the Danbury manufacturing facility, an insulin manufacturing plant in Germany, and even an impressive headquarters building in sunny California. As of the end of 2021, each of these valuable assets has been sold to raise cash where obviously the MannKind executives have seen that Afrezza will never generate enough revenue to maintain the corporation. Now instead of making mortgage payments, they are paying rent for commercial strip office space ($40,000.00 monthly rent) and a manufacturing plant in Danbury, Connecticut, where they yearly pay $9.5 million in rent to the new owners of this facility. MannKind had multi-millions invested in the Danbury facility and in recent additions to expand the facility they added millions to their investment. In the end, they sold the facility for a net of $102million. Within a short time, the paltry net sum of cash they got by selling their hard asset will be gone, gone, gone! In fact, the $102 million, in just the annual rent payments these funds will be gone in about 10 years.

Details of the MannKind Partnership with United Therapeutics – Good or Bad Deal?

There are certain components of the partnership deal between MannKind and United that are unknown to the small investors. But there are certain features of the alliance that can be ascertained with a little research.

This is what we do know. MannKind will conduct the manufacturing of the drug at their now rented Danbury facility. They will then deliver the packaged product with ancillary components to United for marketing. MannKind will be “reimbursed” for their manufacturing on a cost-plus basis. This means that MannKind will only earn revenue for the plus allocation. The actual cost of manufacturing the product will be a reimbursement amount for what MannKind had spent on manufacturing. In addition to the manufacturing reimbursement on a cost-plus basis, MannKind will receive a low double-digit percentage based on a net of all expenses incurred by United.

What does this all mean? Using hypothetical examples due to not knowing the specifics of the cost-plus manufacturing nor the exact amount of the net revenue sharing I will use the following in my example:

Cost of manufacturing that MannKind will incur initially, $40,000,000.00 per year broken into four quarters –$10million a quarter. Cost-plus payment 8% of the cost for the manufacturing. Net revenue sharing at 12%.

Looking at United’s third quarter, 2021, SEC filings, we can see they had net revenue of $162.1 million for Tyvasso sales. We can highly anticipate that Liquidia will be launching their already tentative FDA-approved dry powder inhaled version of their competing product. But for our example, let’s keep the $162.1 million in our calculations for expected revenue coming to MannKind.

For manufacturing cost let’s assume the cost-plus will be 8%–keeping in mind that MannKind is initially funding the manufacturing cost and will be reimbursed for this expense on a delayed basis. Also, United will be providing the supply of treprostinil for MannKind to manufacture the final product. Investors must remember-the other expenses are reimbursed for the money they spent on the manufacturing. The only actual income is the cost-plus amount. So, let’s assume the manufacturing cost is $10,000,000 a quarter. Keep in mind MannKind is maintaining a full staff of manufacturing employees, where the demand for manufacturing Afrezza is not funding their employment cost. This gives MannKind a quarterly cost-plus income of $800,000.00 for the United product. On a yearly basis that makes an income to MannKind being $3.2 million.

So now we have a quarterly net revenue amount of $162.1million, but we know that 100% of such sales will not immediately convert to Tre-T, they will stay on Tyvasso. For example, let’s use a 50% conversion for a starting point. This gives us a net revenue for Tre-t being $81.05 million a quarter.

Now being generous with United’s money let’s say their net revenue payments will be 12%. Doing simple math tells us that MannKind will generate on a quarterly basis $9,726,000 in royalty payments. Plus, $800,000.00 in cost-plus manufacturing income.

This means quarterly MannKind will generate $10.5 million from this partnership. At the maximum, this means that the United partnership will provide a yearly revenue of just a tad more than $40million dollars. Already and before the United revenue starts flowing toward MannKind, they have annual operating expenses about double this “potential” influx of new revenue. It appears MannKind is a long way from generating one penny of profit-profit that is desperately needed for a company that has been 30+ years in existence.

Two things need to happen–MannKind needs to stop spending money trying to market Afrezza by thinking they will eventually turn a profit. The second thing MannKind needs to do is get out of a manufacturing deal like the one they have with United. Keep in mind, every dollar that MannKind spends making the product, that expense is applied toward the operating expense for United and the eventual net revenue that is used to calculate the royalty income for MannKind.

We also know that in their partnership documentation for this partnership, United stated the following in Article 5-(b): At least six months prior to the anticipated launch of the product, UT shall prepare a three-year NON-BINDING high-level plan for the marketing, detailing ……” Basically, United is limiting their exposure to only three years of effort in achieving a non-binding plan for marketing the product. Investors need to remember; the product is owned by United. One must never forget, the Sanofi deal and what happened with that partnership.

So, on February 17th, 2022, MannKind’s CEO knew what United’s marketing plan was for the product involved. And at this stage and with constant contact with the FDA on the pending decision, United and MannKind should have some modicum of understanding of what the labeling requirements will be. I openly admit that I had no idea what the specifics are, but something has created an urgency for MannKind to start cutting its operating expenses.

But this is not the end of this story!

Liquidia vs. MannKind/United Therapeutics

Keep in mind, Al Mann created MannKind to find a way to deliver insulin another way other than by injecting it into the patient’s body. Mann’s plans developed when he bought in 1991 Pharmaceutical Discovery Corporation that included the Technosphere System. With this system, the manufacturing cost of turning insulin/or any drug into a dry powder and being inhaled brought the extra cost to the product. You cannot just make a talc powder-type product if you want to inhale such. The use of an excipient is critical to the process. In fact, all pill formulations use excipients – with the vast majority using a lactose-based foundation.

This is what MannKind states on their corporate website:

With our innovative Technosphere® inhalation technology, our team of dedicated scientists and medical professionals are developing therapeutics products for people with endocrine and orphan lung diseases to help give them control of their health and live life without limits.

What is unfolding in the use of Treprostinil for an inhaled dry powder treatment for PAH patients is boiling down to a competition between United’s product and Liquidia’s product. So, what are the differences, and which one will be most cost-effective for the patients? Bottom line-what will be the cost to make the dry powder formulations? Will it be MannKind’s Technosphere system or will it be Liquidia’s PRINT® technology?

MannKind

Liquidia

Active Drug Component

Treprostinil

Treprostinil

Method of Delivery

Inhaled(DPI)

Inhaled(DPI)

Excipient Used

FDKP

Not FDKP

FDA Status

CRL

Approved

A keen eye can easily see that for the first two criteria items-active drug and method of delivery, they are the same. But when you get to the next two criteria of evaluation -they differ.

For MannKind, using their proprietary Technosphere system, this means they are using their proprietary excipient-FDKP. As for Liquidia, we know they are not using FDKP. Therefore, we know that FDKP didn’t impact the FDA decision because they have stated they have approved Liquidia’s candidate for use by patients suffering from PAH. The MannKind product has been denied and is subject to resolving what United and MannKind have referred to as being an issue with analytical results from a third-party supplier. The active ingredient for the two products is treprostinil so one can assume this was the issue with the FDA. This leaves the excipient as the probable cause for the FDA concern since the FDA approved Liquidia’s submission. We may never know since both United and MannKind had opted not to share the causation issue. All we know is there was an issue with what United filed with the FDA.

The World’s Best Delivery System

Let me repeat a key part of my previous MNKD article where the CEO made the following claim about their Technosphere delivery system.

(I have highlighted the key claims made by the CEO.)

Our team developed the inhaler and cartridge with a careful eye on flow mechanics. Inside that simple inhaler is a sophisticated flow engine tuned for MannKind’s inhalation powders. The engine runs very efficiently by focusing air flows to lift, break up, and move the powder into a patient’s airway at the slowest possible rates. Moving the powder slowly is key. Slower flow rates during powder delivery translate to low levels of inertia and a greater likelihood for deep lung delivery. It allows the powder to navigate through all the twists and turns of the lung and deposit deep in the lung alveoli. There, the large surface area and high level of vascularization make fast absorption possible. Most asthma inhalers deliver powder at 60-90 liters per minute. By contrast, we deliver powders at 15-20 liters per minute. The slower flow also means the patients can inhale longer because their lungs do not fill immediately.

If there still is any ambiguity for what MannKind’s CEO wants investors to believe about MannKind’s Technosphere System, the following are his comments from September 2020:

And so, I think, you know, I’m not aware of anyone else in the world that has the precision of other technology and how we do – what we do the fill cartridges to get the admitted dose to deliver consistently that dose – I don’t know if anyone has that precision around the world and dry powder technology. So not going to say can’t be invented or, you know, adapted over the next decade. But right now, today, I don’t think there’s anyone that could copy what we do, where we are today.

MannKind claims they have the world’s best dry powder drug technology system so what have they done to prove this claim?

On December 7th, 2020, MannKind spent more than $10 million in asset value to buy a company not having one iota of human clinical trial development data they had personally generated or collected. But what is important is what the CEO claimed about this deal to develop a drug based on a drug compound that was discovered more than 70 years ago-clofazimine.

This is what the CEO stated about clofazimine:

“We have focused on building a stronger pipeline to treat unmet needs for orphan lung diseases, an area where we can leverage our experience and technology to create differentiated therapeutic products,” said Michael Castana, Chief Executive Officer of MannKind. “This acquisition brings us a lead program that is expected to enter Phase 1 in late 2021. In addition, our combined capabilities have the potential to create a dry powder formulation that will enable patients suffering from NTM to have a much more positive treatment experience. We are also very excited to add the QrumPharma development team to our roster of talent, with their deep expertise of inhaled drug delivery.”

Where should I start with examining the claims made in this groundbreaking press release other than the items I’ve highlighted for my readers.

  • Building a “stronger pipeline” and they do this by spending money on a drug that was discovered 70 years ago. Novartis has the drug in question, where they have an FDA-approved drug, but they can’t sell it because of a small issue of safety and massive side effects. Currently, there are huge numbers of unheard-of researchers seeking a product to run research and publish a report in some academic journal, I will not use space and time to list them here. In the academic world, there is an old adage-“publish or perish”. So many of them seek drugs that are in the public domain and will not cost much to purchase samples – which Novartis will supply in this case-clofazimine.
  • Create differentiated therapeutic products” and they opt for a drug that has been around for 70 years.
  • Lead product that is expected to enter Phase I in late 2021. But my calendar says that in a matter of days we will be entering the month of March, in the year 2022. This has been the history of MannKind. Make announcements about their pipeline and string it out for years and suddenly wipe the slate and start with a new pipeline- some of the older pipeline candidates – cancer, migraine, epinephrine for anaphylactic shock, a drug to prolong a woman’s pregnancy until full-term in third world countries, a covid drug they talked about in 2020. The list is long and the failure to deliver is longer.

What has the team of scientists at MannKind been doing, for more than a year, with their dry powder formulation using their Technosphere technology? Bearing in mind-Technosphere is touted as being the world’s-leading dry powder delivering system. So why has MannKind dropped using this world’s best technology and reverted to using a nebulizer to deliver a liquid version of the leading pipeline product they bought for about $11million in assets in 2020? This is assuming they will ever start the required clinical trials approved by the FDA.

What does MannKind’s decision to personally drop using Technosphere for their drug development and them thinking that drug companies will be flocking to them in wanting to form a parentship for using Technosphere®? Better yet! Why would United be interested in developing more drugs with MannKind when MannKind has dropped using the Technosphere system for developing their own pipeline? United already has the expertise in creating nebulizer-delivered drugs.

Pfizer, Sanofi and MannKind – What Do They Have in Common?

And finally, there is the question I asked at the very beginning of this article. What do Pfizer, Sanofi, Al Mann, and MannKind all have in common? Al Mann suggested he and MannKind had this issue under full control as they developed Afrezza – the albatross that has destroyed many drugs in the marketplace. However, the first entity that faced this issue and failed was Pfizer, where they used their dominant position in the drug industry, and they sought full insurance coverage for Exubera. Next was Al Mann personally claiming he had the insurance coverage for Afrezza handled-no problem! The next entity that attempts to get needed insurance coverage was Sanofi. Now for the last seven years with MannKind once again in control of Afrezza, they have sought the lucrative top-tier insurance coverage for Afrezza. The point is since 2006, 16 years ago, we have known that insurance companies will not fully cover a drug that is merely supplanting a drug that is already approved and cost less than the “new kid on the block.”

Drug companies operate seeking to make a profit selling their drugs. Insurance companies seek to make a profit by controlling their payments for a drug company’s drugs. Investors should understand this business model. Especially those investing in Afrezza thinking it would become the multi-billion dollar selling insulin product and thus making them rich. There is a valuable lesson in the Afrezza saga. In our healthcare system, the insurance companies win the daily battles because they are not concerned about how an effective drug is dosed to one of their insured clients. The cost and resulting profits rule the day!

Currently, United Therapeutic’s top-selling drug is Tyvasso, a nebulized delivered version using treprostinil as the active ingredient. In partnership with MannKind, they have before the FDA an inhaled version of the same drug, using what we know is a more expensive delivery system-Technosphere. I think it’s a logical assumption-United must charge more for this new version simply to achieve the same profit level they have with the current Tyvasso product. Same drug, same route of getting the drug into the patient’s body, so why would anyone expect that insurance companies will treat the reimbursement any differently than how they have covered Afrezza? Especially now that MannKind has shown that even they will not use the Technosphere system to deliver any new drug they wish to get FDA approval! If the nebulizer is now good enough for MannKind, do you not think that cost and getting insurance coverage for the cheapest delivery system was not a part of their decision-making process?

It is my sincere hope that Afrezza remains available for those patients needing options for treating their medical condition. And good luck getting the PAH drug approved by the FDA. I hope that drug companies keep working on bringing new drugs to the market if they can improve the human condition. However, here in the United States, we have a health care system that is based on insurance companies controlling their claim payments-use Afrezza as your reminder. Just like drug companies, insurance companies want to make huge profits!

Conclusion

I have opted to write about medical/biotech stocks because of a long-term interest in anything related to science. Writing articles for the Seeking Alpha platform gives me the opportunity to combine my science background with my interest in the stock market. I have no hidden agenda when it comes to my writing about MannKind. I clearly state I currently hold no position in their stock-long or short! More than seven years ago, I held a long position in their stock. I sold this position because in doing more due diligence, especially the initial partnership deal with Sanofi, and knowing the history and science that unfolded with the first FDA-approved insulin product, I formed the opinion that delivering insulin via the lungs was fraught with major issues. With the Sanofi partnership being initially announced, I went on record with a SA article where I questioned such an alliance. After only 11 months of trying to market Afrezza, Sanofi canceled their partnership. I didn’t do a victory dance with my opinion being validated by the abrupt dissolvement of this ill-advised union by two drug companies. In fact, and even in this newest article, I clearly state that it is my wish that Afrezza remains available for those patients needing options for treating their medical condition. I want MannKind to survive! I want MannKind to grow its pipeline! I simply want our country to have a viable and productive drug industry creating new and beneficial drugs for human beings.

So, this is what I would say to those invested or considering an investment in MannKind’s stock:

  1. Don’t invest in a biotech stock if you don’t understand the basic principles of the applicable science and the ramifications that can develop in the best-conceived ideas that everything put into medical clinical trials will be successful.
  2. Try to understand there are failures in the biotech arena-if you don’t believe this, look at Kodiak Sciences (KOD) today (2/23/2022). Those invested in their stock have seen their collective valuation decline by more than $2 billion today. This Kodiak story translates into never investing in one stock more than what you can lose, and it does not impact your financial position and your well-being –personal and family.
  3. Read the SEC filings submitted by a company that you want to invest your money in. Listening to fireside chats is not the place to see what is really happening within a company.
  4. As it relates to Afrezza, things are looking very dire for generating a profit based on the current COGs expenses. The only solution I see is selling the product to a small specialty pharma with a provision they will continue to manufacture the product for them. This brings me to the next solution-convert their business model to becoming a manufacturing company. Get out of the drug development industry. As I point out in my article, the United partnership could generate $40 million dollars, what is killing MannKind is the massive cash burn promoting and trying to sustain Afrezza. Use the $100 million obtained with the sale of the real estate and use it to buy time to become a manufacturer of drugs. Trying to make a 70 old drug into a profit-making product isn’t going to pay the bills that MannKind currently has.
  5. Even Warren Buffett admits he has made investing mistakes-but he cuts his losses before they bankrupt him! This would be a good idea for anyone investing in the stock market. Even I have made investing mistakes!

Good luck with your future investing decisions!



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