1Q 2024 Earnings Call

May 8, 2024

© Copyright 2024. All rights reserved. MannKind Corporation.

Cautionary Statement

This presentation includes forward-looking statements relating to, without limitation, our future commercial growth and pipeline advancement, our ability to commercialize pharmaceutical products, statements regarding the commencement of clinical studies of MNKD-101 and MNKD-201, and the data read-outs from clinical studies of Afrezza and MNKD-201. 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 risks and uncertainties, which include, without limitation, risks associated with manufacturing and supply, risks associated with developing product candidates, stock price volatility and other risks detailed in our filings with the Securities and Exchange Commission ("SEC"), including under the "Risk Factors" heading our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 27, 2024. You are cautioned not to place undue reliance on these forward-looking statements. which speak only as of the date of this presentation. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this presentation.

2 © Copyright 2024. All rights reserved. MannKind Corporation.

Today's Agenda

Operational and

Michael Castagna, CEO

Pipeline Highlights

Financial Review

Steven B. Binder, EVP &

Former CFO

Additional Comments

Michael Castagna, CEO

Analyst Q&A

3 © Copyright 2024. All rights reserved. MannKind Corporation.

Michael Castagna

Chief Executive Officer

4 © Copyright 2024. All rights reserved. MannKind Corporation.

Our mission is to give people control of their health and the freedom to live life.

5 © Copyright 2024. All rights reserved. MannKind Corporation.

1Q 2024 Highlights

Orphan Lung

Diseases

UT: Tyvaso DPI

MNKD Pipeline

  • Record royalty revenue of $22.7M (+94%) and record manufacturing-related revenues of $24.8M (+118%)
  • MNKD-101 (clofazimine inhalation susp): FDA Fast Track Designation; FDA clearance for IND; expect Phase 3 registrational trial ICoN-1 to start in 2Q
  • MNKD-201 (nintedanib DPI): FDA clearance to proceed to Ph1 trial; expect Phase 1 trial to start in 2Q

Endocrine

Diseases

Financial

  • 1Q Afrezza net revenue of $14.4M: +16% vs. 2023
  • Afrezza INHALE-1:26-week top line results expected by EOY

Endo BU • Afrezza INHALE-3

      • Positive first meal dosing results presented at ATTD in March
      • 17-weektop-line results at ADA in June
    • India - Subject Expert Comm recommended permission to import & market
  • GAAP Net income of $11M
  • Ended 1Q24 with $304M in cash, cash equivalents and investments (+$2M vs. 4Q)
  • Repaid MidCap senior secured debt and Mann convertible debt first week of April

6 © Copyright 2024. All rights reserved. MannKind Corporation. / 8 May 2024

NTM: MNKD-101

Clofazimine Inhalation

Suspension

7 © Copyright 2024. All rights reserved. MannKind Corporation. / 8 May 2024

NTM prevalence is increasing over time and market will likely exceed $1Billion by end of decade with two players

NTM Epidemiology

NTM Patients per Year

  1. K
  1. K
  1. K
  1. K
  1. K
  1. K
  1. K

223

212

202

193

183

175

166

159

122 131 141 151 162 175 188 202

234

217

246

233

258

251

2022 NTM disease prevalence of 122K

and 159K patients in the U.S. and Japan

• The prevalence rate of NTM is increasing

globally

• Within the U.S., claims-based studies

suggest an annual NTM prevalence

CAGR of 7.5%1

• NTM prevalence and CAGRs suggest a

2032 prevalence of >500K patients in

Japan and U.S.

NTM Prevalence

2022

2023

2024

2025

2026

2027

2028

2029

2030

2031

2032

(K)

159

166

175

183

193

202

212

223

234

246

258

Japan

U.S.

122

131

141

151

162

175

188

202

217

233

251

8

1 Winthrop. An Am Thorac Soc.2020.

ICoN-1 Ph 3 Study Design - Cleared to Proceed by FDA; FDA Fast-TrackDesignation Received

Screening

Treatment Cycle 1 Treatment

Treatment Cycle 2 Treatment

OLE

Day

Day

84

168

End of 28

End of 28

MNKD-101 + GBT

Day Dosing

Off Period

Day Dosing

QD

QD

Patients on GBT for

min 6 months

Placebo + GBT

Alignment with the FDA on co-primary endpoints:

  • Sputum conversion
  • Patient Reported Outcomes

Phase 3 study expected to enroll first patient in June 2024 Orphan + QIDP designation (potential 12 years exclusivity)

Off Period

EOT

Primary Endpoint

Interim

Analysis at

50% patients

9 © Copyright 2024. All rights reserved. MannKind Corporation.

Pulmonary Fibrotic Diseases:

MNKD-201

Nintedanib DPI

10 © Copyright 2024. All rights reserved. MannKind Corporation. / 8 May 2024

Attachments

  • Original Link
  • Original Document
  • Permalink

Disclaimer

MannKind Corporation published this content on 09 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 May 2024 18:07:10 UTC.