MNKD Investors

Technosphere®

One of the largest organs in your body are the lungs. Picture the size of a full tennis court and that is roughly the surface area of both lungs in a typical adult.

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NTM Lung Disease on the Rise

“I cough every morning upon waking, so I don’t feel rested.” “Imagine not being able to breathe.” “Anxiety ruins everything about you – it’s not a normal life.” “You just exist from day to day and week to week.”

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What exactly is the Technosphere® Platform?

One of the largest organs in your body are the lungs. Picture the size of a full tennis court and that is roughly the surface area of both lungs in a typical adult. Running through those lungs are airways whose total length measures 1,500 miles – that’s the distance between Chicago and Las Vegas, New York to Albuquerque, and Los Angeles to Nashville.

Simply put, the lungs create a wonderful platform for effective drug delivery. MannKind’s Technosphere technology recognizes this and provides the distinct advantage of rapid, deep lung drug delivery. The effect is similar to intravenous delivery (I.V.; within a vein) and has the added benefit of bypassing the liver which can be especially helpful in reducing systemic side effects.

Examining it closer, it helps to look at inhalation, air flow travel, and the exhale. When you breathe in, air is drawn into the lung and flows down curving, narrowing airways that end in the air sacs or alveoli. When air is exhaled, the flow is reversed. Between the end of an inhalation and the start of exhalation, the air in the lung is stationary. To reach the deep lung, inhaled particles must be carried by the air stream and have enough momentum to continue through the stationary air to collide with the lung surface.

Particles that can reach the lung have aerodynamic diameters between 0.5 µm and 5-6 µm (1 µm is 1 micro-meter or about 0.00004 inches). Particles that are larger than 6 µm will leave the air stream and hit the back of your mouth and throat; smaller than 0.5 µm wouldn’t have the ability to reach the lungs and would simply get exhaled.

“The average Technosphere particle is about 2-2.5 µm which is in the middle of the respirable range,” explains Marshall Grant, PhD, MSc, Executive Director, Clinical Pharmacology & Research for MannKind Corporation. “The particle size distribution is a major reason Technosphere powders are highly efficient in delivering drug to the lungs than other dry powder inhalers (DPIs).”

The Technosphere particles in FDA-approved Afrezza® (insulin human) Inhalation Powder and Tyvaso DPI™ (treprostinil) Inhalation Powder are manufactured by different processes and possess different characteristics. But both are made up of small crystals of FDKP (fumaryl diketopiperazine), MannKind’s proprietary molecule. FDKP provides high solubility and fast dissolution at physiologic pH – and more importantly – can crystallize and form particles in the range appropriate for optimum delivery to the lungs.

When Technosphere powder reaches the lung surface, the FDKP and drug dissolve. The FDKP is then rapidly cleared from the lung into systemic circulation. The FDKP is not metabolized, but rather excreted primarily in the urine. Another value of Technosphere powders has been their versatility – they are compatible with a wide range of doses with different types of drugs.

MannKind’s Technosphere powders are delivered into the lung’s airstream via an inhalation device or DPI (dry powder inhaler). The breath-powered inhalers (Dreamboat® being the most common version) provide excellent delivery efficiency and are proven to deliver up to 70% of the dry-powder dose deep into the lungs. Our DPI are designed to be simple, easy to use and discreet. For patients, imagine having a drug in the convenient form of an inhaler that fits in the palm of your hand. This approach allows patients to not only take control of their health but do it while going about their day and enjoying life more humann.

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NTM Lung Disease on the Rise

“I cough every morning upon waking, so I don’t feel rested.” “Imagine not being able to breathe.” “Anxiety ruins everything about you – it’s not a normal life.” “You just exist from day to day and week to week.” These are a sampling of comments about the most bothersome symptoms from living with Nontuberculous Mycobacteria (NTM) shared in a study from NTM Info & Research, Inc. The statements are unfortunately typical and those with NTM often have unpredictable day-to-day health functioning and reduced quality of life.

NTM lung disease is a serious infection that is caused by bacteria that are common in the environment and can cause lung damage. The reality is that we are all exposed to these bacteria in our day-to-day lives – more than 120 species of mycobacteria have been identified. These common bacteria exist in water and soil particles that are in the air, wet places like hot tubs, steamy bathrooms, dishwashers, and even the dewy ground we walk on at the park. But not everyone is at risk of getting NTM lung disease just because they are exposed.

Those predisposed often have underlying conditions such as asthma, COPD, and bronchiectasis, which makes them prone to NTM infection. NTM is not considered to be contagious. Women over the age of 65 make up the majority of those impacted, with a predominance in those of Caucasian and Asian descent.

A rare disease, NTM can often be difficult to diagnose. Many will experience coughing, fatigue, weight loss and shortness of breath – all of which are common with other lung disease symptoms and other conditions like tuberculosis. With NTM, symptoms often worsen, and that is a marker not to be ignored.

It is estimated that some 86,000 individuals are living with NTM lung diseases, and it is on the rise growing 8% each year. Coastal regions including Gulf States have higher rates of infection accounting for 70% of annual NTM cases.

While no cure is available, treatments to manage NTM are available. Treatment for NTM involves antibiotic and multidrug regimens with duration lasting from months to years with tolerability and adverse reactions to treatment which often leads to a lack of adherence to therapy.

There is a valuable need to develop medicines that are well tolerated and effective that lends to consistent patient use and alleviates symptoms of NTM lung disease. MannKind continues to progress MNKD-101 (Clofazimine) for the treatment of NTM.

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Ownership Profile

Institutional Shareholder Rotation

Shareholder Holders Value Chg ($MM) % O/S Share Change
Buyers 119 40.99 4.13 11,171,421
Sellers 112 -71.03 6.97 -18,868,816
Net -30.04 2.84 -7,697,395

Institutional Shareholder Concentration

Value ($MM) % O/S Shares
Total Inst. 517.52 51.88 140,435,611
Top 10 Inst. 319.68 32.45 87,823,415
Top 20 Inst. 386.79 38.97 105,481,330
Top 50 Inst. 461.88 46.39 125,568,992

Institutional Shareholder Style

Style Holders Value ($MM) % Inst Shares Shares
Growth 49 41.81 4.25 11,515,011
Aggressive Growth 4 4.61 0.47 1,265,238
Core Growth 35 25.35 2.57 6,952,570
Growth 10 11.86 1.22 3,297,203
Income 7 3.28 0.33 902,148
Income Value 3 3.05 0.31 837,029
Yield 4 0.24 0.02 65,119
Index 31 236.71 23.97 64,885,520
Other 82 185.22 18.79 50,873,956
Broker Dealer 21 24.43 2.48 6,711,470
GARP 22 28.95 2.94 7,953,532
Hedge Fund 36 99.03 10.05 27,196,416
Specialty 2 0.05 -- 12,538
VC Private Equity 1 32.76 3.33 9,000,000
Value 31 15.78 1.58 4,282,511
Core Value 26 12.19 1.22 3,298,721
Deep Value 5 3.59 0.36 983,790

Top Holders: Institutional Investor

Holder Shares Held % O/S Share Change Filing Date
BlackRock Institutional Trust Company, N.A. 20,192,570 7.46 1,754,703 12/31/23
The Vanguard Group, Inc. 15,196,069 5.61 598,895 12/31/23
State Street Global Advisors (US) 12,940,395 4.78 723,794 12/31/23
Nitorum Capital, L.P. 10,831,390 4.00 360,621 12/31/23
Avoro Capital Advisors LLC 9,000,000 3.33 -- 12/31/23
Fidelity Management & Research Company LLC 5,940,883 2.19 -517,746 12/31/23
Geode Capital Management, L.L.C. 5,842,775 2.16 327,795 12/31/23
D. E. Shaw & Co., L.P. 2,988,025 1.10 -1,219,366 12/31/23
Parkman Healthcare Partners LLC 2,498,624 0.92 429,677 12/31/23
Goldman Sachs Asset Management, L.P. 2,392,684 0.88 129,979 12/31/23
Northern Trust Investments, Inc. 2,348,311 0.87 143,930 12/31/23
Emerald Advisers LLC 2,165,500 0.80 -3,161,928 12/31/23
Two Sigma Investments, LP 2,114,895 0.78 -1,807,017 12/31/23
Charles Schwab Investment Management, Inc. 2,066,844 0.76 30,433 12/31/23
180 Wealth Advisors, L.L.C. 1,942,210 0.72 216,880 3/31/24
Marshall Wace LLP 1,938,828 0.72 -1,284,233 12/31/23
Invesco Capital Management LLC 1,651,975 0.61 154,362 12/31/23
Castagna (Michael E) 1,251,317 0.46 -935,761 3/21/24
Voya Investment Management LLC 1,152,919 0.43 36,296 12/31/23
Citadel Advisors LLC 1,025,116 0.38 -823,142 12/31/23
Schonfeld Strategic Advisors LLC 1,014,888 0.37 41,688 12/31/23
Nuveen LLC 968,456 0.36 334,700 12/31/23
Apollo Capital Management, L.P. 964,113 0.36 -- 12/31/23
Morgan Stanley & Co. LLC 945,254 0.35 337,010 12/31/23
Millennium Management LLC 884,005 0.33 -3,081,322 12/31/23
Rafferty Asset Management LLC 817,113 0.30 -38,688 12/31/23
Connor, Clark & Lunn Investment Management Ltd. 752,824 0.28 12,746 12/31/23
Oberweis Asset Management, Inc. 722,800 0.27 -75,600 12/31/23
Tross Stuart A 719,553 0.27 -316,756 3/21/24
UBS Financial Services, Inc. 717,483 0.27 386,868 12/31/23
BlackRock Financial Management, Inc. 716,943 0.26 25,196 12/31/23
BofA Global Research (US) 715,299 0.26 137,336 12/31/23
BNY Mellon Asset Management 711,224 0.26 48,986 12/31/23
Barclays Bank PLC 710,912 0.26 230,352 12/31/23
Scopia Capital Management LP 694,961 0.26 -- 12/31/23
BlackRock Investment Management, LLC 680,177 0.25 1,662 12/31/23
First Trust Advisors L.P. 669,493 0.25 456,065 12/31/23
Lazard Asset Management, L.L.C. 662,723 0.24 284,408 12/31/23
Susquehanna International Group, LLP 650,011 0.24 183,776 12/31/23
Goldman Sachs & Company, Inc. 617,667 0.23 204,846 12/31/23
Binder (Steven B) 552,345 0.20 -273,146 3/21/24
Schweizerische Nationalbank 528,900 0.20 -52,100 12/31/23
1492 Capital Management, LLC 516,948 0.19 -4,100 12/31/23
GSA Capital Partners LLP 500,522 0.18 337,494 12/31/23
Goldman Sachs Asset Management International 499,564 0.18 -- 1/31/24
Thomson (David B) 493,482 0.18 -438,514 3/21/24
Qube Research & Technologies Ltd 434,238 0.16 -125,531 12/31/23
Jane Street Capital, L.L.C. 421,600 0.16 142,827 12/31/23
BlackRock Advisors (UK) Limited 415,022 0.15 10,272 3/31/24
UBS Asset Management (Americas), Inc. 389,142 0.14 -9,868 3/31/23

* Insider values reflect direct beneficial ownership.

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