2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation.
Cautionary Statement
This presentation includes forward-looking statements relating to the development, commercialization and benefits of our investigational product candidates, including AFREZZA, that are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected herein. The words "believe," "expect," "intend," "anticipate," "plan," variations of such words, and similar expressions identify forwardlooking statements, but their absence does not mean that a statement is not forward-looking. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult for us to predict. Factors that could affect the development and commercialization of our investigational product candidates include the progress and costs of clinical trials and the timing of regulatory approvals, the availability of clinical materials from third-party suppliers, and MannKind's ability to manufacture and commercialize its products, if and when approved, in a timely and cost-effective manner, and other risks and uncertainties described in MannKind's current and periodic reports filed with the Securities and Exchange Commission, including MannKind's annual report on Form 10-K for the year ended December 31, 2012.
2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation.
2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation.
Global Epidemic
Prevalence of Diabetes 2013-2035
68.9 56.3 50.4 36.7 67.9 138.2 123.0 72.1 201.8
34.6
38.5 24.1
41.4
19.8
2013 2035
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Large pool of insulin users and growing pool of patients who will transition to insulin ~500,000 new insulin users each year
Source: CDC, National Diabetes Fact Sheet, 2010; 2012 Roper US Diabetes Patient Market Study (Gfk Healthcare 2012)
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~$4 billion in annual sales in 2012 Consistent double digit competitive price increases
$4,500 $4,000 $3,500
($ millions)
$3,000 $2,500 $2,000 $1,500 $1,000 $500 $0 2007 2008 2009 2010 2011 2012
Apidra
Humalog
Novolog
67% patients concerned about hypoglycemia 74% physicians would treat to target if no fear of hypoglycemia events
Source: GAPP Survey (Global Attitudes of Patients and Physicians in Insulin Therapy), 2010, Novo Nordisk.
2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation.
2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation.
AFREZZA
Changing the Way Diabetes is Treated
Meal synchronization
Improved compliance
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AFREZZA
2.00
1.50 1.00 0.50
0.00 -60
60
120
240
300
360
420
2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation.
No cleaning required
Breath powered Efficient delivery to deep lung
2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation.
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Assuming regulatory approval, how likely are you to use AFREZZA in your practice in the future?
100% 90%
94%
95%
% of Physicians
48% 28%
30%
20%
4%
10% 0%
Yes
No
2008
2009
2010
Source: Close Concerns, Diabetes Close Up; HCP Survey ADA 2008, 2009, 2010.
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2013 Resubmission
Addresses
Demonstrates Builds
Bridges
safety
Resubmission Advisory
Committee date
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MedTone
Possible AFREZZA users may be patients with type 2 diabetes who have failed oral antidiabetic medications and who prefer to add an inhaled insulin product with the goal of delaying the need for injectable antidiabetic therapy. Overall, the type 2 diabetes Study should focus on the most likely users of AFREZZA among type 2 patients so that results can be the most generalizable.
End of Review meeting May 4, 2011
Gen2
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Screening Phase
4-Week Follow-Up
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17
18
p = 0.0156
20 16 12 8 4 0
p < 0.0001
29%
14.0 9.8
Afrezza
Novolog
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Gen2 and MedTone inhalers have comparable, clinically insignificant changes in pulmonary function Both arms return to comparator treatment line after discontinuation
0.4
0.3
0.2
0.1 0.0 -0.1 -0.2 -0.3 -0.4 Baseline Week 12 Week 24 Week 28
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AFREZZA demonstrated advantages both in terms of hypoglycemia and weight Study 171 establishes a bridge for the Gen2 inhaler to the safety data from the prior submissions
MKC-TI-171
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Randomization
Screening Phase
Pre-Treatment Phase
Follow-Up 4 Weeks
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Trial in patients poorly controlled on oral agents Type 2 registration trial designed as superiority
0 -0.2 -0.4 -0.6
-0.8
-1
Afrezza + oral agents Placebo + oral agents
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MKC-TI-175
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Safety Summary
AFREZZA safety is supported by extensive clinical program involving more than 5,600 patients and healthy volunteers for up to two years AFREZZA is well tolerated
Most common adverse event is mild, throat-clearing cough
Observed cancer rate does not exceed the expected rate in a similar population No increase in cardiovascular risk
0.96 Relative Risk for all diabetes patients
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Launch
Full
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Financial Summary
$30 million available under line of credit from Mann Group LLC
$40 million debt funding (2nd tranche) from
Projected cash burn rate of ~$10-12 million per month reflects continued ramp towards commercialization
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AFREZZA Takeaways
Blockbuster potential
Large and growing patient population Poorly met medical need
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