MannKind Corporation RBC 2014

©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


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


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


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%


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


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.


“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


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


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


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


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


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%


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


“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®


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


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


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


-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


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


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


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


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


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


Launch capacity: up to 375 million cartridges per year

Full capacity: up to 2 billion cartridges per year (capex required)

Danbury, CT Production Capabilities


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


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


Our focus is patients, our passion is innovation®

MannKind Corporation

Documents

MannKind Corporation RBC 2014