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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

MannKind Corp BOFA May 2014

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MannKind Corp BOFA May 2014

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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.

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    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-nave 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

    (

    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 lispro RAA

    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

  • 2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 13

    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

    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

  • 2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 16

    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. 18

    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 H

    yp

    og

    lycem

    ia

    Afrezza Novolog

    p = 0.0156

    p < 0.0001

  • 2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 19

    -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

    Mean

    Ch

    an

    ge f

    rom

    Baselin

    e i

    n F

    EV

    1(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

  • 2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 20

    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. 21

    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

  • 2014 MannKind Corporation. All rights reserved. No copying or distribution of this material may be made without written consent of MannKind Corporation. 23

    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

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    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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    2013 Resubmission

    Addresses FDA Complete Response Letters

    Demonstrates efficacy using Gen2 device

    Bridges from MedTone to Gen2 for pulmonary

    safety

    Advisory Committee recommended approval:

    13 to 1 for Type 1

    14 to 0 for Type 2

    PDUFA date extended from

    April 15 to July 15, 2014

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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 $35.8 million at March 31, 2014

    $30 million available under line of credit from Mann Group LLC

    $20 million debt funding received from Deerfield on May 6, 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: July 15, 2014

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    Our focus is patients, our passion is innovation

    MannKind Corporation