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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Release Details

MannKind Corporation Reports 2022 First Quarter Financial Results

05/05/22
PDF Version
Conference Call to Begin Today at 5:00 p.m. (ET)
  • 1Q 2022 Afrezza Net Revenue of $9.8 million; +21% vs. 1Q 2021
  • 1Q 2022 Afrezza Gross Margin 77%; Gross Profit +99% vs 1Q 2021
  • $233.0 million of Cash, Cash Equivalents, and Investments at March 31, 2022
  • Tyvaso DPI PDUFA date May 2022

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended March 31, 2022.

“As we approach the FDA action date for Tyvaso DPI, our company is focused on supporting United Therapeutics in their planned commercial launch,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “Our endocrine business unit execution has resulted in Afrezza net revenue growth of 21% vs. the first quarter 2021 and we continue to add sites and patients into our Afrezza pediatric trial, INHALE-1.”

Total revenues were $12.0 million for the first quarter of 2022, reflecting Afrezza net revenue of $9.8 million and collaborations and services revenue of $2.2 million. Afrezza net revenue increased 21% compared to $8.1 million in the first quarter of 2021 as a result of wholesaler inventory ordering patterns for the first quarter of 2021, which was adversely impacted as wholesalers decreased inventory levels, plus price, which included more favorable gross-to-net deductions. Collaborations and services revenue decreased $7.2 million compared to the first quarter of 2021 primarily due to the completion of the R&D Services associated with our collaboration with United Therapeutics (“UT”). In August 2021, we entered into a commercial supply agreement (“CSA”) with UT. Revenue associated with the CSA is deferred as of March 31, 2022 and will be recognized over the period when commercial product is sold to UT. The deferred revenue balance associated with the CSA increased by $7.1 million in the first quarter to $25.7 million as of March 31, 2022.

Afrezza gross profit for the first quarter of 2022 was $7.5 million compared to $3.8 million in the same period of 2021, an increase of $3.8 million, or 99%, which was driven by an increase in Afrezza sales and a decrease in cost of goods sold. The Afrezza cost of goods sold decreased by $2.0 million, or 47%, compared to the same period in 2021, primarily as a result of the absorption of manufacturing-related costs due to the manufacturing of a second product. Afrezza gross margin in the first quarter of 2022 was 77% compared to 47% for the same period in 2021.

Cost of revenue – collaborations and services increased by $5.4 million in the first quarter of 2022 compared to the same period in 2021 primarily due to an increase in costs of manufacturing activities in preparation for supplying commercial product to UT.

Research and development expenses for the first quarter of 2022 were $3.5 million compared to $2.4 million for the first quarter of 2021. This $1.1 million increase was mainly related to costs incurred for research and development activities for our product pipeline, including a phase 1 clinical trial for inhaled clofazimine.

Selling, general and administrative expenses for the first quarter of 2022 were $20.7 million compared to $17.4 million for the first quarter of 2021. This $3.3 million increase was primarily attributable to an enhanced primary care physician-focused promotional campaign that began in the fourth quarter of 2021, Afrezza territory restructuring costs, as well as promotional and patient support services expenses to support Afrezza sales growth.

For the first quarter of 2022, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $2.0 million compared to $3.8 million for the first quarter of 2021. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest expense on financing liability was $2.4 million for the first quarter of 2022 and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT.

Interest expense on debt for the first quarter of 2022 was $2.7 million compared to $6.5 million for the first quarter of 2021. This decrease of $3.7 million was primarily due to a milestone payment obligation that was achieved during the first quarter of 2021, partially offset by an increase in interest expense related to our senior convertible notes.

The net loss for the first quarter of 2022 was $26.0 million, or $0.10 per share, compared to $12.9 million in the first quarter of 2021, or $0.05 per share. The $13.1 million increase in the net loss was primarily due to a decrease in revenues from collaboration and services and an increase in the cost of revenue for collaborations and services. Revenue associated with the CSA is deferred as of March 31, 2022 and will be recognized over the period when commercial product is sold to UT. The increase in cost of revenue for collaborations and services was primarily due to an increase in costs of manufacturing activities in preparation for supplying commercial product to UT.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind's website for 14 days.

About MannKind Corporation 

MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company’s first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company’s partner, Biomm SA. MannKind was established in 1991, and is located in Danbury, Conn., and Westlake Village, Calif. The Company also employs field sales and medical representatives across the U.S. Please visit mannkindcorp.com to learn more.

Forward-Looking Statements

Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding the expected PDUFA date for Tyvaso DPI and our ability to support United Therapeutics in its planned commercial launch of Tyvaso DPI. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks associated with: the FDA may not complete its review of the NDA for Tyvaso DPI on the timeframe expected for various reasons, including due to disruptions that may be caused by personnel shortages, citizen petitions and the COVID-19 pandemic; the FDA may determine not to approve Tyvaso DPI; and if we fail as an effective manufacturing organization, we may be unable to support commercialization of Tyvaso DPI, if approved. These and other are risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 24, 2022, and in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, being filed with the SEC later today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

Tyvaso DPI is an investigational combination product that is not approved for any use in any country. The Tyvaso DPI tradename is pending final FDA review. TYVASO DPI is a trademark of United Therapeutics Corporation.

AFREZZA is a registered trademark of MannKind Corporation.

MannKind Contact:
Rose Alinaya, Investor Relations
(818) 661-5000

MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)

  March 31, 2022   December 31, 2021
ASSETS              
Current assets:              
Cash and cash equivalents $ 67,243     $ 124,184  
Short-term investments   95,203       79,932  
Accounts receivable, net   9,823       4,739  
Inventory   8,044       7,152  
Prepaid expenses and other current assets   3,952       3,482  
Total current assets   184,265       219,489  
Property and equipment, net   41,453       36,612  
Long-term investments   70,542       56,619  
Other assets   12,058       8,441  
Total assets $ 308,318     $ 321,161  
               
LIABILITIES AND STOCKHOLDERS' DEFICIT              
Current liabilities:              
Accounts payable $ 8,702     $ 6,956  
Accrued expenses and other current liabilities   27,131       27,419  
Financing liability — current   9,410       6,977  
Deferred revenue — current   1,307       827  
Recognized loss on purchase commitments — current   6,944       6,170  
Total current liabilities   53,494       48,349  
Senior convertible notes   224,307       223,944  
Midcap credit facility   38,939       38,833  
Promissory notes   18,425       18,425  
Accrued interest — promissory notes   520       404  
Financing liability — long term   93,463       93,525  
Recognized loss on purchase commitments — long term   72,400       76,659  
Operating lease liability   826       1,040  
Deferred revenue — long term   26,116       19,543  
Milestone rights liability   4,838       4,838  
Deposits from customer   7,054       4,950  
Total liabilities   540,382       530,510  
Stockholders' deficit:              
Undesignated preferred stock, $0.01 par value — 10,000,000 shares authorized;
no shares issued or outstanding as of March 31, 2022 and December 31, 2021		   —       —  
Common stock, $0.01 par value - 400,000,000 shares authorized,
252,413,434 and 251,477,562 shares issued and outstanding
at March 31, 2022 and December 31, 2021, respectively		   2,524       2,515  
Additional paid-in capital   2,922,555       2,918,205  
Accumulated other comprehensive loss   (1,076 )     —  
Accumulated deficit   (3,156,067 )     (3,130,069 )
Total stockholders' deficit   (232,064 )     (209,349 )
Total liabilities and stockholders' deficit $ 308,318     $ 321,161  
 

MANNKIND CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)

  Three Months Ended
March 31,		  
  2022   2021
Revenues:              
Net revenue — commercial product sales $ 9,826     $ 8,099  
Revenue — collaborations and services   2,166       9,337  
Total revenues   11,992       17,436  
Expenses:              
Cost of goods sold   2,284       4,315  
Cost of revenue — collaborations and services   8,714       3,295  
Research and development   3,536       2,442  
Selling, general and administrative   20,697       17,413  
Gain on foreign currency translation   (1,983 )     (3,838 )
Total expenses   33,248       23,627  
Loss from operations   (21,256 )     (6,191 )
Other (expense) income:              
Interest income, net   377       3  
Interest expense on financing liability   (2,371 )     —  
Interest expense on notes   (2,748 )     (6,452 )
Other expense   —       (276 )
Total other expense   (4,742 )     (6,725 )
Loss before provision for income taxes   (25,998 )     (12,916 )
Provision for income taxes   —       —  
Net loss $ (25,998 )   $ (12,916 )
Net loss per share - basic and diluted $ (0.10 )   $ (0.05 )
Shares used to compute net loss per share - basic and diluted   251,887       246,631  

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Source: MannKind