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.

picture 1

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.

picture 1

Release Details

MannKind Corporation Reports 2022 Fourth Quarter and Full Year Financial Results

02/23/23
PDF Version
Conference Call to Begin Today at 5:00 p.m. (ET)
  • 2022 Total Revenues of $100 million; +32% vs. 2021
  • 2022 Royalties from Tyvaso DPI of $16 million; 4Q 2022 of $9 million
  • 4Q 2022 Commercial Products Net Revenue of $17 million;+54% vs. 4Q 2021
  • $173 million of Cash and Cash Equivalents and Investments at December 31, 2022

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 23, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the fourth quarter and full year ended December 31, 2022.

“For 2022, we recognized almost $100 million in total revenues – an incredible triumph for our entire organization,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “With our revenues growing nicely, we are focusing on our product pipeline where our INHALE-1 Phase 3 trial for Afrezza in pediatrics reached 50% enrollment at December 31, 2022 and our inhaled clofazimine will move into an adaptive Phase 2/3 study in the second half of 2023.”

Fourth Quarter 2022 Results

Revenue Highlights

  For the Three Months Ended
December 31,		  
  2022     2021     $ Change     % Change  
Net revenue — Afrezza $ 12,006     $ 11,340     $ 666       6 %
Net revenue — V-Go   5,434       —     $ 5,434     *  
Revenue — collaborations and services   9,544       1,175     $ 8,369       712 %
Royalties — collaborations   9,075       —     $ 9,075     *  
Total revenues $ 36,059     $ 12,515     $ 23,544       188 %

______________________________
* Not meaningful

The increase in Afrezza® net revenue was mainly a result of higher demand. V-Go was acquired in the second quarter of 2022. The increase in collaborations and services revenue reflected the fact that the manufacture of Tyvaso® DPI for commercial sale had not yet commenced in the previous period. Royalties from United Therapeutics (“UT”) for Tyvaso DPI continued to grow based on strong patient demand.

Afrezza gross margin in the fourth quarter of 2022 was 92% compared to 62% for the same period in 2021, mainly due to a decrease in cost of goods sold driven by lower inventory write offs, lower cost of production per unit and a higher amount of manufacturing activity in 2022 (which absorbed more cost to inventory). V-Go® gross margin was 42% for the fourth quarter of 2022.

Cost of revenue – collaborations and services for the fourth quarter of 2022 was $12.0 million compared to $7.1 million for the same period in 2021, an increase of $4.9 million, primarily due to an increase in manufacturing activities associated with the production of Tyvaso DPI.

Research and development (“R&D”) expenses for the fourth quarter of 2022 were $7.2 million compared to $3.9 million for the same period in 2021. This $3.3 million increase was primarily attributed to costs incurred to develop our product pipeline, including the Afrezza pediatrics clinical study (INHALE-1) and MNKD-101 (inhaled clofazimine).

Selling expenses for the fourth quarter of 2022 were $11.6 million compared to $13.5 million for the same period in 2021. This $1.9 million decrease was primarily attributable to the net impact of lower personnel-related costs associated with the first quarter of 2022 Afrezza sales force restructuring, and a pilot promotional effort aimed at primary care physicians that began in the fourth quarter of 2021 and ended in the third quarter of 2022, partially offset by V-Go promotional efforts.

General and administrative (“G&A”) expenses for the fourth quarter of 2022 were $10.5 million compared to $9.2 million for the same period in 2021. This $1.3 million increase was primarily attributable to higher stock-based compensation and increased headcount.

Interest expense on financing liability was $2.5 million for the fourth quarter of 2022 and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT, which was entered into in the fourth quarter of 2021.

Interest expense on notes was flat in the fourth quarter of 2022 compared to the same period in 2021 due to fixed interest rates and no changes in debt balances.

Year Ended December 31, 2022

Revenue Highlights

  For the Year Ended
December 31,		  
  2022     2021     $ Change     % Change  
Net revenue — Afrezza $ 43,316     $ 39,168     $ 4,148       11 %
Net revenue — V-Go   12,931       —     $ 12,931     *  
Revenue — collaborations and services   27,924       36,274     $ (8,350 )     (23 %)
Royalties — collaborations   15,599       —     $ 15,599     *  
Total revenues $ 99,770     $ 75,442     $ 24,328       32 %

______________________________
* Not meaningful

Afrezza net revenue increased year-over-year primarily due to higher price (including a more favorable gross-to-net adjustment), higher product demand, and a more favorable cartridge mix. Collaborations and services revenue decreased, primarily due to the completion of the R&D services associated with our collaboration with UT, which was partially offset by revenues associated with the manufacturing of Tyvaso DPI. As of December 31, 2022, $37.9 million of manufacturing revenue associated with Tyvaso DPI remains deferred and will be recognized as commercial product is sold to UT.

Afrezza gross margin for 2022 was 80% compared to 57% for the same period in 2021, driven primarily by a decrease in excess manufacturing capacity costs (as Tyvaso DPI was in commercial production in 2022), a decrease in inventory write offs and an amendment fee associated with our Insulin Supply Agreement in 2021. V-Go gross margin was 43% for 2022.

Cost of revenue – collaborations and services for 2022 was $41.5 million compared to $22.0 million for the same period in 2021, an increase of $19.5 million, primarily due to an increase in manufacturing activities for the production of Tyvaso DPI.

R&D expenses for 2022 were $19.7 million compared to $12.3 million for the prior year. This $7.4 million increase was primarily attributable to costs incurred to develop our product pipeline, including INHALE-1 and MNKD-101.

Selling expenses for 2022 were $53.8 million compared to $45.5 million for the prior year. This $8.3 million increase was primarily attributable to the primary care pilot program, elimination of the Thyquidity co-promotion (which permitted some expenses associated with the sales force to be recognized as cost of revenue for collaborations and services in the same period of 2021), V-Go promotional efforts after the acquisition in the second quarter of 2022, and partially offset by the net favorable impact of personnel-related costs associated with the Afrezza sales force restructuring in 2022.

G&A expenses for 2022 were $37.7 million compared to $31.9 million for the prior year. This $5.8 million increase was primarily attributable to higher stock-based compensation, increased headcount, and higher professional fees.

Interest expense on the financing liability was $9.8 million for 2022 and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT.

Interest expense on notes was flat for 2022 compared to 2021 due to fixed interest rates and no changes in debt balances.

Cash and cash equivalents and investments as of December 31, 2022 were $172.8 million.

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

MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases.

We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, pulmonary arterial hypertension (PAH) and nontuberculous mycobacterial (NTM) lung disease. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation.

With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.

Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, Twitter or Instagram.

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 MannKind’s revenue growth and pipeline advancement, including the planned adaptive Phase 2/3 study. 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 manufacturing and supply, risks associated with product commercialization, risks associated with developing product candidates, risks associated with MannKind’s ability to manage its existing cash resources or raise additional cash resources, and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, as filed with the SEC on November 8, 2022, and under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2022, being filed with the SEC on February 23, 2023. 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 a trademark of United Therapeutics Corporation.

AFREZZA, MANNKIND, and V-GO are registered trademarks of MannKind Corporation.

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



MANNKIND CORPORATION AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS

  December 31,  
  2022     2021  
  (In thousands except share and per share data)  
ASSETS              
Current assets:              
Cash and cash equivalents $ 69,767     $ 124,184  
Short-term investments   101,079       79,932  
Accounts receivable, net   16,801       4,739  
Inventory   21,772       7,152  
Prepaid expenses and other current assets   25,477       3,482  
Total current assets   234,896       219,489  
Property and equipment, net   45,126       36,612  
Goodwill   2,428       —  
Other intangible asset   1,153       —  
Long-term investments   1,961       56,619  
Other assets   9,718       8,441  
Total assets $ 295,282     $ 321,161  
               
LIABILITIES AND STOCKHOLDERS' DEFICIT              
Current liabilities:              
Accounts payable $ 11,052     $ 6,956  
Accrued expenses and other current liabilities   35,553       27,419  
Financing liability — current   9,565       6,977  
Deferred revenue — current   1,733       827  
Recognized loss on purchase commitments — current   9,393       6,170  
Total current liabilities   67,296       48,349  
Promissory notes   8,829       18,425  
Accrued interest — promissory notes   55       404  
Financing liability — long term   94,512       93,525  
Midcap credit facility   39,264       38,833  
Senior convertible notes   225,397       223,944  
Recognized loss on purchase commitments — long term   62,916       76,659  
Operating lease liability   5,343       1,040  
Deferred revenue — long term   37,684       19,543  
Milestone liabilities   4,524       4,838  
Deposits from customer   —       4,950  
Total liabilities   545,820       530,510  
Stockholders' deficit:              
Undesignated preferred stock, $0.01 par value — 10,000,000
shares authorized; no shares issued or outstanding at
December 31, 2022 and 2021		   —       —  
Common stock, $0.01 par value — 400,000,000 shares authorized,
263,793,305 and 251,477,562 shares issued and outstanding
at December 31, 2022 and 2021, respectively		   2,638       2,515  
Additional paid-in capital   2,964,293       2,918,205  
Accumulated deficit   (3,217,469 )     (3,130,069 )
Total stockholders' deficit   (250,538 )     (209,349 )
Total liabilities and stockholders' deficit $ 295,282     $ 321,161  



MANNKIND CORPORATION AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS

  Three Months Ended
December 31,		     Twelve Months Ended
December 31,		  
  2022     2021     2022     2021  
  (In thousands except per share data)  
Revenues:                              
Net revenue — commercial product sales $ 17,440     $ 11,340     $ 56,247     $ 39,168  
Revenue — collaborations and services   9,544       1,175       27,924       36,274  
Royalties — collaborations   9,075       —       15,599       —  
Total revenues   36,059       12,515       99,770       75,442  
Expenses:                              
Cost of goods sold   4,081       4,295       16,003       16,833  
Cost of revenue — collaborations and services   12,043       7,139       41,494       22,024  
Research and development   7,156       3,886       19,721       12,312  
Selling   11,616       13,536       53,753       45,528  
General and administrative   10,479       9,191       37,720       31,889  
Asset impairment   —       —       —       106  
Loss (gain) on foreign currency translation   3,474       (1,564 )     (4,811 )     (6,567 )
Loss on purchase commitments   —       —       —       339  
Total expenses   48,849       36,483       163,880       122,464  
Loss from operations   (12,790 )     (23,968 )     (64,110 )     (47,022 )
Other (expense) income:                              
Interest income, net   957       48       2,513       112  
Interest expense on financing liability   (2,478 )     (1,373 )     (9,758 )     (1,373 )
Interest expense on notes   (2,809 )     (2,769 )     (15,011 )     (15,204 )
Loss on available-for-sale securities   (932 )     —       (932 )     —  
Loss on extinguishment of debt   —       —       —       (17,200 )
Other income (expense)   105       1       (102 )     (239 )
Total other expense   (5,157 )     (4,093 )     (23,290 )     (33,904 )
Loss before income tax expense   (17,947 )     (28,061 )     (87,400 )     (80,926 )
Provision for income taxes   —       —       —       —  
Net loss $ (17,947 )   $ (28,061 )   $ (87,400 )   $ (80,926 )
Net loss per share — basic and diluted $ (0.07 )   $ (0.11 )   $ (0.34 )   $ (0.32 )
Shares used to compute net loss per share
— basic and diluted		   263,378       251,083       257,092       249,244  


Primary Logo

Source: MannKind