mannkind investor relations

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 Completes Acquisition of scPharmaceuticals, Accelerating Revenue Growth in Cardiometabolic Care

10/07/25
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DANBURY, Conn. and BURLINGTON, Mass., Oct. 07, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) successfully completed the previously announced acquisition of scPharmaceuticals Inc.

The acquisition of scPharmaceuticals is expected to diversify and accelerate MannKind’s double-digit revenue growth, driven by FUROSCIX® (furosemide injection)- an innovative therapy for edema due to chronic heart failure and chronic kidney disease. The transaction will strengthen MannKind’s commercial and medical capabilities by integrating scPharmaceuticals’ experienced team into its existing infrastructure. MannKind is positioned as a diversified, growth-focused biopharmaceutical company with its commercial assets—Afrezza®, FUROSCIX® and V-Go® -- along with Tyvaso DPI®-related revenues, contributing to an annualized run rate of over $370 million based on Q2 2025 results. Additionally, the FUROSCIX ReadyFlow™ Autoinjector supplemental New Drug Application (sNDA) filing was submitted as planned in Q3 2025.

“With the close of the acquisition, MannKind now has multiple revenue lines with strong growth potential, a deepening presence in cardiometabolic care, and a commercial infrastructure ready to support the next phase of growth,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “This milestone accelerates our strategy to build a patient-centric company that delivers innovative therapies for chronic disease.”

The strategic fit between the two organizations creates meaningful growth opportunities, combining MannKind’s endocrinology expertise and infrastructure with scPharmaceuticals’ deep cardiovascular capabilities. MannKind is positioned to expand FUROSCIX’s reach with nephrologists and cardiologists and to continue its success in chronic heart failure treatment. The potential for long-term value creation is further supported by MannKind’s late-stage pipeline, including Inhaled Clofazimine for the treatment of nontuberculous mycobacterial lung disease and nintedanib DPI for the treatment of idiopathic pulmonary fibrosis.

Transaction Details
The acquisition was structured as a tender offer to acquire all of the outstanding shares of scPharmaceuticals common stock at a price of $5.35 per share in cash plus one non-tradable contingent value right (CVR) per share to receive certain milestone payments of up to an aggregate of $1.00 per CVR in cash, for total consideration of up to $6.35 per share in cash. The non-tradable CVR is payable upon achieving certain regulatory and net sales milestones.

The tender offer expired at one minute following 11:59 p.m., Eastern Time, on October 6, 2025. The depositary for the tender offer advised MannKind and scPharmaceuticals that scPharmaceuticals stockholders holding approximately 73.47% of the outstanding shares of scPharmaceuticals common stock had tendered their shares, satisfying the minimum condition to consummate the tender offer. In addition, notices of guaranteed delivery were delivered for shares representing approximately 10.91% of the outstanding shares of scPharmaceuticals common stock. All of the conditions of the tender offer having been satisfied, MannKind accepted for payment all such tendered shares, and following a statutory merger under Section 251(h) of the Delaware General Corporation Law on October 7, 2025, scPharmaceuticals became a wholly owned subsidiary of MannKind. All remaining shares of scPharmaceuticals common stock that were not tendered in the tender offer were converted into the right to receive the same per share consideration as shares that were tendered in the tender offer, as described above.    

With the completion of the transaction, shares of scPharmaceuticals’ common stock, which traded on the Nasdaq under the symbol “SCPH,” will cease trading as of today and will no longer be listed on the Nasdaq.

About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Learn more at mannkindcorp.com.

INDICATION

FUROSCIX® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome.

IMPORTANT SAFETY INFORMATION

FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives. 

Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients.  Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.

Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.

Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.

In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.

Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.

The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Please see the full Prescribing Information (https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf) and Instructions for Use ( https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf)

Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “will”, “goal” and similar expressions. These forward-looking statements include, without limitation, statements related to the expected benefits from the acquisition of FUROSCIX, including diversifying and accelerating revenue growth, MannKind’s strategy to build a patient-centric company that delivers innovative therapies for chronic disease, and strengthening MannKind’s organization and revenue base; MannKind’s growth potential and the growth opportunities created by the acquisition of FUROSCIX; the potential for long-term value creation; the annualized revenue run rate implied by Q2 2025 results; MannKind’s late-stage pipeline including MNKD-101 and MNKD-201 and the ongoing and planned clinical trials and timing thereof; and other statements that are not historical facts. These forward-looking statements are based on MannKind’s current expectations and inherently involve significant risks and uncertainties. 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, the risk that MannKind will not be able to retain the employees of scPharmaceuticals given the at-will nature of their employment; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; risks associated with developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of clinical trials and reporting data; the possibility that if MannKind does not achieve the expected benefits of the acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of MannKind’s shares could decline; historical revenue growth rates may not be achieved in future periods for various reasons, including competition, execution, and adverse regulatory and reimbursement changes; and other risks related to MannKind’s business detailed from time-to-time under the caption “Risk Factors” and elsewhere in MannKind’s SEC filings and reports, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent quarterly and current reports filed with the SEC. MannKind undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in expectations, except as required by law.

FUROSCIX is a registered trademark of scPharmaceuticals Inc., a subsidiary of MannKind Corporation.

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

TYVASO DPI is a registered trademark of United Therapeutics Corporation.


MannKind Contacts:
Media Relations
Christie Iacangelo
Email: media@mnkd.com

Investor Relations
Ana Kapor
Email: ir@mnkd.com

Katherine Miranda
Email: kmiranda@scpharma.com

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Source: MannKind