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 2021 Fourth Quarter and Full Year Financial Results

02/24/22
PDF Version

Conference Call to Begin Today at 5:00 p.m. (ET) 

  • 2021 Total Revenues of $75.4 million; +16% vs. 2020
  • 4Q 2021 Afrezza Net Revenue of $11.3 million; +13% vs. 4Q 2020
  • $260.7 million of Cash, Cash Equivalents and Investments at December 31, 2021
  • Commenced clofazimine Phase 1 clinical trial in 1Q 2022
  • Tyvaso DPI review deadline extended to May 2022

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the fourth quarter and full year ended December 31, 2021.

“We had a solid fourth quarter with Afrezza net revenue hitting a record $11.3 million and we ended the year with over $260 million in cash and investments on our balance sheet,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “Although the extension of the Tyvaso DPI review is frustrating, our manufacturing team remains focused on producing pre-launch supplies of Tyvaso DPI for our collaboration partner, United Therapeutics.”

Fourth Quarter 2021 Results

Total revenues were $12.5 million for the fourth quarter of 2021, reflecting Afrezza net revenue of $11.3 million and collaborations and services revenue of $1.2 million. Afrezza net revenue increased 13% compared to $10.1 million in the fourth quarter of 2020 as a result of higher demand, a more favorable cartridge mix, price, and lower gross-to-net deductions. Collaborations and services revenue decreased $7.2 million compared to the fourth quarter of 2020 due to a decrease in revenue recognized from the initial License Agreement with United Therapeutics (“UT”), which was substantially completed in the third quarter of 2021. Revenue associated with the commercial production of Tyvaso DPI was deferred in the fourth quarter of 2021 and will be recognized over the period when commercial product is sold to UT.

Afrezza gross profit for the fourth quarter of 2021 was $7.0 million compared to $6.4 million in the same period of 2020, an increase of $0.6 million, or 10%, which was driven by an increase in Afrezza sales, partially offset by an increase in cost of goods sold. Cost of goods sold increased by $0.6 million, or 18%, compared to the same period in 2020, primarily due to a $2.0 million increase in inventory write-offs partially offset by $1.8 million in reduced manufacturing-related spending. Afrezza gross margin in the fourth quarter of 2021 was 62% compared to 64% for the same period in 2020.

Cost of revenue – collaborations and services increased by $4.5 million in the fourth quarter compared to 2020 due to increased pre-approval manufacturing activity for Tyvaso DPI.

Research and development (“R&D”) expenses for the fourth quarter of 2021 were $3.9 million compared to $1.5 million for the fourth quarter of 2020. This $2.4 million increase was mainly related to pre-clinical development of inhaled clofazimine as well as the Afrezza pediatrics clinical study (INHALE-1).

Selling, general and administrative (“SG&A”) expenses for the fourth quarter of 2021 were $22.7 million compared to $17.1 million for the fourth quarter of 2020. This $5.6 million increase was primarily attributable to higher Afrezza promotional expenses and patient support services as well as increased stock-based compensation.

For the fourth quarter of 2021, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $1.6 million compared to a loss of $4.0 million for the fourth quarter of 2020. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest expense on financing liability was $1.4 million for the fourth quarter of 2021 and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT.

Interest expense on debt for the fourth quarter of 2021 was $2.8 million compared to $2.4 million for the fourth quarter of 2020. This increase of $0.4 million was the result of interest on the $230.0 million 2.5% senior convertible notes issued in the first quarter of 2021, partially offset by a decrease in interest expense on Mann Group promissory notes as a result of (i) the repayment of $35.1 million of outstanding principal under the Mann Group non-convertible note, (ii) the $10.0 million reduction of principal and interest on the Mann Group convertible note from a conversion to our common stock and (iii) a decrease of the interest rate from 7.00% to 2.50% on the remaining promissory note.

The net loss for the fourth quarter of 2021 was $28.1 million, or $0.11 per share, compared to $26.4 million in the fourth quarter of 2020, or $0.11 per share. The $1.7 million increase in the net loss was primarily due to a decrease in revenues from collaboration and services as well as increases in cost of revenue for collaborations and services and in SG&A expenses, partially offset by a gain on purchase commitment as well as the effect of the one-time acquisition of in-process R&D from QrumPharma in the fourth quarter of 2020.

Twelve Months Ended December 31, 2021

Total revenues were $75.4 million for the year ended December 31, 2021 reflecting Afrezza net revenue of $39.2 million and collaborations and services revenue of $36.3 million. Afrezza net revenue increased 21% compared to $32.3 million for the year ended December 31, 2020, primarily driven by higher demand, a more favorable cartridge mix, price, and lower gross-to-net deductions. Collaborations and services revenue increased $3.5 million compared to 2020 due to additional development work associated with our collaboration with UT.

Afrezza gross profit was $22.3 million for the year ended December 31, 2021, an increase of $5.1 million, or 30%, compared to a gross profit of $17.2 million in the prior year, which was attributable to an increase in Afrezza sales, partially offset by an increase in cost of goods sold. Cost of goods sold increased by $1.8 million, or 12%, for the year ended December 31, 2021 compared to the prior year, primarily due to a $2.0 million fee for the amendment of the Insulin Supply Agreement, a $1.5 million increase in inventory write-offs, and a $1.0 million increase related to reduced manufacturing activities. The increase in cost of goods sold was partially offset by $2.3 million in reduced manufacturing-related spending, lower per-unit cost from increased manufacturing efficiencies and the termination of a free goods program in December 31, 2020.

R&D expenses for the year ended December 31, 2021 were $12.3 million compared to $6.2 million for the prior year. This $6.1 million increase was primarily attributable to costs incurred to develop our product pipeline and to begin the Afrezza pediatrics clinical study (INHALE-1).

SG&A expenses for the year ended December 31, 2021 were $77.4 million compared to $59.0 million for the prior year. This $18.4 million increase was primarily attributable to higher Afrezza promotional expenses, patient support services, increased headcount and stock-based compensation and our voluntary reduction in compensation in the prior year in response to the COVID-19 pandemic.

For the year ended December 31, 2021, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $6.6 million compared to a loss of $8.0 million for the prior year. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest expense on financing liability was $1.4 million for the year ended December 31, 2021 and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT.

Interest expense on debt for the year ended December 31, 2021 was $15.2 million compared to $9.5 million for the prior year. This $5.7 million increase was primarily due to interest expense on the $230.0 million 2.5% senior convertible notes as well as a $3.7 million milestone obligation that was achieved during the first quarter of 2021, partially offset by a decrease in interest expense on Mann Group promissory notes as a result of (i) the repayment of $35.1 million of outstanding principal under the Mann Group non-convertible note, (ii) the $10.0 million reduction of principal and interest on the Mann Group convertible note from a conversion to our common stock and (iii) a decrease of the interest rate from 7.00% to 2.50% on the remaining promissory note.

The net loss for the year ended December 31, 2021 was $80.9 million, or $0.32 per share, compared to $57.2 million net loss for the year ended December 31, 2020, or $0.26 per share. The higher net loss was mainly attributable to the $22.1 million non-cash loss on extinguishment of the Mann Group convertible note net of a $4.9 million non-cash gain on extinguishment of the PPP loan, as well as an increase in SG&A expenses and in cost of revenue – collaboration and services, partially offset by an increase in Afrezza net revenues and revenues from collaboration and services, a gain on purchase commitment as well as the effect of the one-time acquisition of in-process R&D from QrumPharma in the prior year. On a non-GAAP basis, excluding the expense incurred for the loss on extinguishment of the Mann Group convertible note offset by the gain on extinguishment of the PPP loan, and the Amphastar amendment fee, the net loss for the year ended December 31, 2021 was $61.7 million, or $0.25 per share.

Cash, cash equivalents, restricted cash, and investments as of December 31, 2021 was $260.7 million compared to $67.2 million as of December 31, 2020. The increase was mainly due to the sale of senior convertible notes in the first quarter of 2021 for $230.0 million and the cash received from the sale-leaseback of our Danbury, CT manufacturing facility of approximately $100 million, offset by operating costs for 2021.

Non-GAAP Measures

To supplement our unaudited condensed consolidated financial statements presented under U.S. generally accepted accounting principles (GAAP), we are presenting certain non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.

These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our unaudited condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

The following table reconciles our gross margin financial measure to a non-GAAP presentation as adjusted for the nonrecurring amendment fee related to an amendment to our Insulin Supply Agreement.

  Twelve Months Ended
December 31,		  
  2021     2020  
Net revenue — commercial product sales $ 39,168     $ 32,324  
Less cost of goods sold   (16,833 )     (15,084 )
GAAP gross profit — Afrezza   22,335       17,240  
Exclude Amphastar amendment fee   2,000       —  
Non-GAAP gross profit — Afrezza $ 24,335     $ 17,240  
Non-GAAP gross margin   62 %     53 %

The following table reconciles our financial measure for net loss and net loss per share as reported in our consolidated statement of operations to a non-GAAP presentation as adjusted for the $22.1 million non-cash loss on extinguishment of the Mann Group convertible note net of the $4.9 million gain on extinguishment of the PPP loan for the year ended December 31, 2021, which did not result in a change in our financial position, as well as the $2.0 million Amphastar amendment fee.

    Three Months Ended
December 31,		     Twelve Months Ended
December 31,		  
    2021     2020     2021     2020  
GAAP to Non-GAAP Net Loss and EPS                                
Net loss   $ (28,061 )   $ (26,411 )   $ (80,926 )   $ (57,240 )
GAAP net loss per share — basic and diluted   $ (0.11 )   $ (0.11 )   $ (0.32 )   $ (0.26 )
                                 
Less non-cash loss on extinguishment of debt, net     —       —       17,200       —  
Less Amphastar amendment fee     —       —       2,000       —  
Non-GAAP net loss   $ (28,061 )   $ (26,411 )   $ (61,726 )   $ (57,240 )
Non-GAAP net loss per share — basic and diluted   $ (0.11 )   $ (0.11 )   $ (0.25 )   $ (0.26 )

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 MannKind’s future commercial growth and pipeline advancement, and MannKind’s ability to commercialize pharmaceutical products. 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 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, the impact of the COVID-19 pandemic, stock price volatility 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, 2021, as filed with the SEC on November 9, 2021, and under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2021, being filed with the SEC on February 24, 2022. 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
ir@mannkindcorp.com


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

    December 31,  
    2021     2020  
    (In thousands except share and per share data)  
ASSETS                
Current assets:                
Cash and cash equivalents   $ 124,184     $ 67,005  
Restricted cash     —       158  
Short-term investments     79,932       —  
Accounts receivable, net     4,994       4,218  
Inventory     7,152       4,973  
Prepaid expenses and other current assets     3,482       3,122  
Total current assets     219,744       79,476  
Property and equipment, net     36,612       25,867  
Long-term investments     56,619       —  
Other assets     8,186       3,265  
Total assets   $ 321,161     $ 108,608  
                 
LIABILITIES AND STOCKHOLDERS' DEFICIT                
Current liabilities:                
Accounts payable   $ 6,956     $ 5,582  
Accrued expenses and other current liabilities     27,419       19,707  
Financing liability — current     6,977       —  
Paycheck Protection Program loan — current     —       4,061  
Deferred revenue — current     827       33,275  
Recognized loss on purchase commitments — current     6,170       11,080  
Total current liabilities     48,349       73,705  
Promissory notes     18,425       63,027  
Accrued interest — promissory notes     404       4,150  
Financing liability — long term     93,525       —  
Long-term Midcap credit facility     38,833       49,335  
Senior convertible notes     223,944       —  
Recognized loss on purchase commitments — long term     76,659       84,208  
Operating lease liability     1,040       1,202  
Deferred revenue — long term     19,543       1,662  
Milestone rights liability     4,838       5,926  
2024 convertible notes     —       5,000  
Paycheck Protection Program loan — long term     —       812  
Deposits from customer     4,950       —  
Total liabilities     530,510       289,027  
Stockholders' deficit:                
Undesignated preferred stock, $0.01 par value — 10,000,000 shares authorized; no shares issued or outstanding at December 31, 2021 and 2020     —       —  
Common stock, $0.01 par value — 400,000,000 shares authorized, 251,477,562 and 242,117,089 shares issued and outstanding at December 31, 2021 and 2020, respectively     2,515       2,421  
Additional paid-in capital     2,918,205       2,866,303  
Accumulated other comprehensive loss     —       —  
Accumulated deficit     (3,130,069 )     (3,049,143 )
Total stockholders' deficit     (209,349 )     (180,419 )
Total liabilities and stockholders' deficit   $ 321,161     $ 108,608  


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

    Three Months Ended
December 31,		     Twelve Months Ended
December 31,		  
    2021     2020     2021     2020  
                                 
Revenues:                                
Net revenue — commercial product sales   $ 11,340     $ 10,064     $ 39,168     $ 32,324  
Revenue — collaborations and services     1,175       8,379       36,274       32,820  
Total revenues     12,515       18,443       75,442       65,144  
Expenses:                                
Cost of goods sold     4,295       3,652       16,833       15,084  
Cost of revenue — collaborations and services     7,139       2,631       22,024       9,557  
Research and development     3,886       1,545       12,312       6,248  
Acquired In-Process R&D     —       13,233       —       13,233  
Selling, general and administrative     22,727       17,121       77,417       59,040  
Impairment of assets     —       —       106       1,889  
(Gain) loss on foreign currency translation     (1,564 )     4,008       (6,567 )     8,006  
Loss on purchase commitments     —       —       339       —  
Total expenses     36,483       42,190       122,464       113,057  
Loss from operations     (23,968 )     (23,747 )     (47,022 )     (47,913 )
Other (expense) income:                                
Interest income     48       2       112       167  
Interest expense on financing liability     (1,373 )     —       (1,373 )     —  
Interest expense on notes     (2,769 )     (2,401 )     (15,204 )     (9,471 )
Loss on extinguishment of debt     —       (264 )     (17,200 )     (264 )
Other (expense) income     1       (1 )     (239 )     23  
Total other expense     (4,093 )     (2,664 )     (33,904 )     (9,545 )
Loss before income tax expense     (28,061 )     (26,411 )     (80,926 )     (57,458 )
Benefit from income taxes     —       —       —       218  
Net loss   $ (28,061 )   $ (26,411 )   $ (80,926 )   $ (57,240 )
Net loss per share — basic and diluted   $ (0.11 )   $ (0.11 )   $ (0.32 )   $ (0.26 )
Shares used to compute net loss per share
 — basic and diluted		     251,083       234,575       249,244       222,585  

 


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Source: MannKind