MannKind Stock

MannKind Corporation operates as a biopharmaceutical company.

The company focuses on the development and commercialization of innovative therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. The company’s signature technologies – Technosphere dry-powder formulations and Dreamboat 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.

In the company’s endocrine business unit, the company commercializes two products: Afrezza (insulin human) Inhalation Powder, an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes, and the V-Go wearable insulin delivery device, which provides continuous subcutaneous infusion of insulin in adults that require insulin. Afrezza was developed by the company and received approval from the FDA in June 2014. Afrezza consists of a dry powder formulation of human insulin delivered from a small portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and delivers insulin quickly to the bloodstream. V-Go received 510(k) clearance by the FDA in 2010 and has been available commercially since 2012. In May 2022, the company acquired V-Go from Zealand Pharma A/S and Zealand Pharma US, Inc. (together ‘Zealand’) and began integrating the product into the company’s endocrine business unit. V-Go is a mechanical basal-bolus insulin delivery system that is worn like a patch and can eliminate the need for taking multiple daily shots. V-Go administers a continuous preset basal rate of insulin over 24 hours and provides discreet on-demand bolus dosing at mealtimes.

The company is solely responsible for the commercialization of Afrezza and V-Go in the United States. Outside of the U.S., the company’s strategy has been to establish regional partnerships in foreign jurisdictions where there are commercial opportunities, subject to the receipt of necessary foreign regulatory approvals. The company’s partner in Brazil, Biomm S.A. (‘Biomm’), commenced commercialization of Afrezza in January 2020. The company’s partner in India, Cipla Ltd. (‘Cipla’), recently submitted a marketing authorization application to the Drug Controller General of India.

The proprietary formulation and inhaler technologies used in Afrezza have also been deployed in the company’s efforts to develop products to treat orphan lung diseases. The first product to come out of the company’s orphan lung disease pipeline, Tyvaso DPI (treprostinil) inhalation powder, received FDA approval in May 2022 for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Tyvaso DPI is the first and only approved dry powder inhaled treatment for PAH and PH-ILD. The company’s development and marketing partner (sometimes referred to as the company’s collaboration partner), United Therapeutics Corporation (‘United Therapeutics’ or ‘UT’) began commercializing Tyvaso DPI in June 2022 and is obligated to pay the company a royalty on net sales of the product. The company also receives a margin on supplies of Tyvaso DPI that the company manufactures for UT.

The lead program in the company’s pipeline of potential treatments for orphan lung diseases is MNKD-101, a nebulized formulation of clofazimine, for the treatment of severe chronic and recurrent pulmonary infections, including nontuberculous mycobacterial (NTM) lung disease. An orally inhaled formulation of clofazimine could potentially provide several clinical advantages over the current solid oral dosage form of this drug. The FDA has designated MNKD-101 as both an orphan drug and a qualified infectious disease product for the treatment of pulmonary NTM infections. The company plans to initiate a Phase 2/3 registrational study of MNKD-101 in the United States in the second quarter of 2024.

The next most advanced program in the company’s pipeline is MNKD-201, a dry-powder formulation of nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF). An oral dosage form of nintedanib was approved for IPF by the FDA in 2014. However, a fairly large oral dose is required in order to achieve sufficient drug levels in lung tissue. The company’s intention with an inhaled formulation is to deliver a therapeutic amount of nintedanib to the lungs while avoiding high levels of the drug in other tissues, where it is associated with undesirable side effects. The company plans to initiate a Phase 1 clinical study of MNKD-201 in the second quarter of 2024.

To aid in the development of oral inhalation products, the company has created a number of innovative tools, including a novel inhalation profiling apparatus, known as BluHale that uses miniature sensors to assess the drug delivery process at the level of an individual inhaler. The BluHale apparatus medical device provides real-time data regarding patient usage and delivery system performance that is transmitted to a user interface, such as a smartphone application. During 2020, the company released a BluHale Professional version of the apparatus for use as a training tool in certain physicians' offices. A consumer version of the apparatus, with additional features, was used as part of a clinical study of Afrezza (the INHALE-3 study) in 2023. The learnings from this study will help guide future releases of the apparatus and its corresponding smartphone application.

Intellectual Property

Afrezza is protected by approximately 630 issued patents and 40 pending patent applications in the United States and selected jurisdictions around the world, the longest-lived of which will expire in 2032. Similarly, Tyvaso DPI is protected by approximately 400 issued patents in the United States and elsewhere and an additional 45 pending patent applications. The longest-lived patent protection for Tyvaso DPI in the company’s portfolio will expire in 2035. Various features of the commercial V-Go device are protected by a portfolio of approximately 110 issued patents and another 18 pending patent applications, the longest-lived of which will expire in 2033. Additional patents and patent applications are expected to provide protection for products in the company’s pipeline, including MNKD-101, MNKD-201, the company’s BluHale inhalation-profiling apparatus and various development tools. The company’s entire worldwide portfolio consists of approximately 1,200 issued patents and approximately 200 pending patent applications.

The company uses trademarks and service marks to protect its corporate brand, as well as the branding associated with Afrezza, V-Go, the company’s Technosphere formulation technology, the company’s device platform and the product support programs that the company has developed. The company’s portfolio consists of approximately 265 registered trademarks and 35 applications in the U.S. and selected foreign jurisdictions.

Competition

The company competes with the manufacturers of GLP-1 analog injection products, such as AstraZeneca PLC, Novo Nordisk A/S, and Eli Lilly and Company.

Government Regulation

As the holder of marketing approvals for Afrezza and V-Go, the company is subject to continuing regulation by the FDA, including post marketing study commitments or requirements, record-keeping requirements, reporting of adverse experiences with the company’s products, submitting periodic reports, drug sampling and distribution requirements, notifying the FDA and gaining its approval of certain manufacturing or labeling changes, and complying with certain electronic records and signature requirements.

As a manufacturer of multiple therapeutic products, including Tyvaso DPI, the company’s Connecticut facility is subject to federal registration and listing requirements, and if applicable, to state licensing requirements. It is also subject to inspection by the FDA and other national regulatory bodies and must comply with current good manufacturing practices (‘cGMPs’), quality system regulations for medical devices (‘QSR’) and other requirements enforced by these regulatory bodies.

If a drug product is reimbursed by Medicare, Medicaid or other federal or state healthcare programs, the company must comply with, among others, the federal civil and criminal false claims laws, including the civil False Claims Act, as amended, the federal Anti-Kickback Statute, as amended, and similar state laws. Similarly, if a drug product is reimbursed by Medicare or Medicaid, pricing and rebate programs must comply with, as applicable, the Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990, as amended, and the Medicare Prescription Drug Improvement and Modernization Act of 2003.

The company is subject to data privacy and security laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. For example, HIPAA, as amended by the Health Information Technology and Clinical Health Act (‘HITECH’), and their respective implementing regulations, imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information.

History

MannKind Corporation was incorporated in the state of Delaware in 1991.