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©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 1 ©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 1
Our focus is patients, our passion is innovation®
Nasdaq: MNKD
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 2 ©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 2
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 forward-looking 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.
Cautionary Statement
3 ©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation.
The first and only ultra rapid-acting insulin
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 4
Global Epidemic Prevalence of Diabetes 2013-2035
Source: International Diabetes Federation Diabetes Atlas, 2013
36.7
50.4
24.1
38.5
56.3
68.9
19.8
41.4
72.1
123.0
201.8
138.2
34.6
67.9
2013
2035
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 5
AFREZZA Product Profile Drives Blockbuster Opportunity
First-in-class ultra rapid-acting insulin
Unique pharmacokinetic profile results in significant clinical benefits
Clinical and patient benefits
Proven HbA1c reductions
Reduced risk of hypoglycemia vs. rapid-acting analogs (“RAAs”)
Less weight gain vs. other prandial insulins
Small, discreet and easy-to-use inhaler
Injection-free insulin delivery
Clinical studies support safety
No long-term or irreversible effects on pulmonary function in up to two
years of clinical assessments
No increased cardiovascular or cancer risk
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 6
U.S. Diabetes Prevalence and Insulin Use is Large and Growing
Source: CDC, National Diabetes Fact Sheet, 2010; 2012 Roper US Diabetes Patient Market Study (Gfk Healthcare 2012)
Large pool of insulin users and growing pool of patients who will transition to insulin
~500,000 new insulin users each year
All Patients: 22,163,000
Insulin Patients: 6,997,000
T1 Pumpers6% T1 MDI
11%
T2 Long-Acting Only
26%
T2 Basal-Bolus24%
T2 Pre-Mix Only14%
T2 Other19%
Insulin Using32%
Orals + GLP1/GLP
Only3%
Orals Only57%
Lifestyle8%
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 7
US RAA Market: Large and Growing
Source: IMS, MIDAS US
~$4 billion in annual sales in 2012
Consistent double digit competitive price increases
$0
$500
$1,000
$1,500
$2,000
$2,500
$3,000
$3,500
$4,000
$4,500
2007 2008 2009 2010 2011 2012
($ m
illions)
Apidra
Humalog
Novolog
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 8
One-third of patients failed to take insulin as prescribed
Insulin treatment challenges:
‒ 67% patients concerned about hypoglycemia
‒ 74% physicians would treat to target if no fear of hypoglycemia events
Limitations of current insulin regimens include:
‒ Hypoglycemia
‒ Slow absorption
‒ Weight gain
‒ Inconvenience of injections
Current Insulin Treatment Challenges
Survey: Global Attitudes of Patients and Physicians in Insulin Therapy
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. 9
“Ideally, the principle of insulin use is the creation of as
normal a glycemic profile as possible without
unacceptable weight gain or hypoglycemia.”
“Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach.
Position Statement of the American Diabetes Association and the European
Association for the Study of Diabetes.” Diabetes Care, 35: 1364-1379, 2012
ADA and EASD Position Statement
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Excellent Control Less Risk
AFREZZA® Changing the Way Diabetes is Treated
Ideal PK/PD Profile
Meal synchronization
Simple, easy to use,
patient-friendly
More Physiologic
Less Hypoglycemia,
Less Weight Gain
Improved
compliance
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Large Patient Population Ripe for Conversion to AFREZZA
• Type 1 and Type 2 patients currently on RAA or Premix
4.2 million – Prandial Insulin Switches
• Type 2 basal-only patients who could benefit from insulin
intensification
1.7 million – New-to-Intensification
• Type 2 insulin-naïve patients who could benefit from insulin
• ~40% of patients are out of glycemic control
• ~500,000 patients convert to insulin annually
15.2 million – New-to-Insulin
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 12
0
10
20
30
40
50
60
70
80
-60 0 60 120 180 240 300 360 420
Ins
uli
n C
on
ce
ntr
ati
on
(µ
U/m
L)
Time (min)
AFREZZA
Insulin lispro
0.00
0.50
1.00
1.50
2.00
2.50
3.00
3.50
4.00
-60 0 60 120 180 240 300 360 420
Co
rre
cte
d G
IR (
mg
/kg
-min
)
Time (min)
AFREZZA
Insulin lisproRAA
First-in-Class Ultra Rapid-Acting Insulin Ideal PK and PD Profiles
Shorter time to peak insulin level…
…results in glucose utilization more syncronized with typical meal digestion
MKC-TI-116 – Type 1
Subjects in Euglycemic
Clamp
RAA
0
0.00
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Small, discreet, easy-to-use inhaler
No injection required
No cleaning required
Breath powered
Efficient delivery to deep lung
Minimal training needed
Disposed after 15 days of use
Preferred Patient Experience
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 14
Increasing Demand for Faster Insulin and Interest in AFREZZA®
94%
4%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
% o
f Physi
cia
ns
“We need insulins that
work faster than current
rapid-acting analogs.”
Source: Close Concerns, Diabetes Close Up; HCP Survey ADA 2008, 2009, 2010.
“Assuming regulatory
approval, how likely are you
to use AFREZZA in your
practice in the future?”
Yes No 2010 2009 2008
28%
48%
95%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 15
2013 Resubmission
Addresses FDA Complete Response Letters
Demonstrates efficacy using Gen2 device
Builds on previously submitted NDA
Bridges from MedTone to Gen2 for pulmonary
safety
Resubmission date: October 13, 2013
Advisory Committee date
Now Confirmed - April 1, 2014
PDUFA date: April 15, 2014
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 16
“You should conduct two randomized, controlled phase 3 trials with the Gen2 device, one in patients with type 1 diabetes and the other in patients with type 2 diabetes. At least, one of these trials should include a treatment group using the MedTone inhaler so that we can obtain a head-to-head comparison of the pulmonary safety data for the two devices.” Complete Response Letter – January 18, 2011
“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
Clinical Studies Designed to Address Complete Response Letter
Gen2
MedTone®
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Pivotal Type 1 Diabetes Trial MKC 171
4-Week Basal
Optimization
12-Week Prandial Insulin
Optimization with continued
Basal Titration
12-Week Stable Insulin Dosing 4-Week
Follow-Up
All subjects
switch to
prandial
insulin aspart
All AFREZZA
treated
subjects
switch to
prandial
insulin aspart
Pre-Treatment
Phase
AFREZZA-MedTone + Basal insulin (N=174)
Insulin aspart + Basal insulin (N=170) Screening
Phase
AFREZZA-Gen2 + Basal insulin (N=174)
Primary Endpoint Non-inferiority in reduction of A1c vs. rapid-acting
analog, both in basal-bolus regimen
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Achieved Primary Endpoint of Non-Inferiority
Source: Study 171
Time Point Statistics
AFREZZA-
Gen2
(N=174)
Insulin
aspart
(N=170)
AFREZZA –
Insulin aspart
Baseline Adj. Mean 7.94 7.92
Week 24 Adj. Mean 7.73 7.52
Week 24 -
Baseline
Adj. Mean Change -0.21 -0.40 0.19
95% CI (0.02, 0.36)
AFREZZA HbA1c reduction was non-inferior to insulin aspart
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 19
Less Risk of Hypoglycemia
Significantly fewer patients experienced severe hypoglycemia
Lower risk of overall hypoglycemia
18%
29%
0%
10%
20%
30%
40%
Inc
ide
nc
e o
f S
eve
re
Hyp
og
lyc
em
ia %
Afrezza Novolog
Source: Study 171
9.8
14.0
0
4
8
12
16
20
Even
t R
ate
of
To
tal
Hyp
og
lycem
ia
Afrezza Novolog
p = 0.0156
p < 0.0001
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-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
Me
an
Ch
an
ge
fro
m B
as
eli
ne
in
FE
V1
(L)
AFREZZA-Gen2
AFREZZA-MedTone
Insulin aspart
Gen2 and MedTone inhalers have comparable, clinically insignificant changes in pulmonary function
Both arms return to comparator treatment line after discontinuation
Source: Study 171
Comparable FEV1 Changes
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Study 171 Conclusions
AFREZZA is non-inferior to insulin aspart with regard
to HbA1c lowering
Study 171 establishes a bridge for the Gen2 inhaler to the safety data from the prior submissions
MKC-TI-171
AFREZZA demonstrated advantages both in terms of hypoglycemia and weight
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 22
Pivotal Type 2 Diabetes Trial MKC 175
Primary Endpoint Demonstrate superior HbA1c reductions following the addition of AFREZZA vs. inhaled placebo to a regimen
of one or more oral antidiabetic agents
Oral Run-In
6 Weeks 12-Week Dose Titration 12-Week Stable Dosing
Follow-Up
4 Weeks
Randomization
Pre-Treatment
Phase
All Subjects
Switch Back
to Usual Care
Orals + Placebo (N=176)
Orals + AFREZZA (N=177)
Screening
Phase
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Achieved Primary Endpoint of Superior A1c Lowering
Trial in patients poorly controlled on oral agents
Type 2 registration trial designed as superiority
-1
-0.8
-0.6
-0.4
-0.2
0
Hb
A1
c
Ch
an
ge
fro
m B
as
elin
e
Afrezza + oral agents Placebo + oral agents
Source: Study 175
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Study 175 Conclusion
For patients with type 2 diabetes who are
insufficiently treated with oral antidiabetic agents, the
addition of AFREZZA produces a significant reduction
in HbA1c, making it an effective first insulin
MKC-TI-175
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 25
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
No clinically meaningful differences in pulmonary function compared to usual care
Small, non-progressive and resolves after discontinuation
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
Safety Summary
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Launch capacity: up to 375 million cartridges per year
Full capacity: up to 2 billion cartridges per year (capex required)
Danbury, CT Production Capabilities
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Financial Summary
Cash and cash equivalents of $70.8 million at 12/31/13
Repaid $115 million convertible debt in December 2013
$30 million available under line of credit from Mann Group LLC
$40 million debt funding (2nd tranche) from Deerfield converted to common shares in December 2013 and January 2014
Projected cash burn rate of ~$10-12 million per month reflects continued ramp towards commercialization
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 28
AFREZZA® Takeaways
• Large and growing patient population
• Poorly met medical need
Blockbuster potential
• Ultra rapid-acting insulin that mimics physiology
• Offers glycemic control without increased risk of hypoglycemia
and weight gain
• Delivered through discreet and easy-to-use inhaler
A new class of insulin therapy
• FDA confirmation of protocols using new, advanced inhaler
• Completed two clinical trials – achieved primary endpoints
PDUFA date: April 15, 2014
©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 29 ©2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 29
Our focus is patients, our passion is innovation®
MannKind Corporation