1Q 2024 Earnings Call
May 8, 2024
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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.
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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 |
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Michael Castagna
Chief Executive Officer
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Our mission is to give people control of their health and the freedom to live life.
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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
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NTM: MNKD-101
Clofazimine Inhalation
Suspension
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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
- K
- K
- K
- K
- K
- K
- 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
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Pulmonary Fibrotic Diseases:
MNKD-201
Nintedanib DPI
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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.