insulet corporation: omnipod® 5 clinical results

1 |

PRESENTERSDr. Trang Ly MBBS FRACP PhDSVP, Medical Director, Insulet Corporation

Dr. Bruce Bode MD FACECEO and President, Atlanta Diabetes AssociatesClinical Associate Professor, Emory University

MODERATORDeborah Gordon VP, Investor Relations, Insulet Corporation

Q&A PANELShacey PetrovicPresident & CEO, Insulet Corporation

Eric BenjaminSVP, Innovation and Strategy, Insulet Corporation

Insulet Investor WebcastMarch 20, 2021, 12:30PM EST

Insulet Corporation:

Omnipod® 5 Clinical Results

CAUTION: Investigational Device, Limited by United States Law to Investigational Use.

2 | INS-N/A-08-2020-00003 V1.0

Forward Looking Statement

This presentation may contain forward-looking statements concerning Insulet's expectations, anticipations, intentions,

beliefs or strategies regarding the future. These forward-looking statements are based on current expectations and

beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future

developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number

of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or

performance to be materially different from those expressed or implied by these forward-looking statements, and other

risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange

Commission in February 2021 in the section entitled "Risk Factors," and in its other filings from time to time with the

Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its

assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking

statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

© 2021 Insulet Corporation, Omnipod, the Omnipod logo, DASH, HypoProtect, SmartBolus and Omnipod 5 are trademarks or registered trademarks of Insulet Corporation. All rights reserved. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.

2 |

+ Omnipod 5 product overview

+ Omnipod 5 pivotal study results presented at ENDO 2021

+ Discussion with Dr. Bruce Bode

+ Q&A

Agenda

3 | CAUTION: Investigational Device, Limited by United States Law to Investigational Use.

4 |

Kate

Kate, age 6Omnipod since 2014


5 |

Kate

Kate, age 13Omnipod 5 pivotal study since 2019

Kate, age 6Omnipod since 2014


7 |

7 | INS-N/A-08-2020-00003 V1.0

First and Only Wearable, Tubeless SolutionThe future of insulin delivery

Pod +Algorithm

Omnipod 5 App

Illustrative purposes only. Final product may or may not be what is represented here.

Fully On-body Automated Insulin Delivery

Novel Features & Function

• Wearable Pod communicates directly with Dexcom G6 Continuous Glucose Monitoring System

• Personalized, adaptive, treat to target algorithm built into the Pod

• Omnipod® 5 app allows users to control the system from a compatible personal smartphone

• Glucose targets from 110-150 mg/dL, adjustable by time of day

• HypoProtect™ for times of reduced insulin needs

• SmartBolus calculator informed by Dexcom G6® CGM value and trend

• Automatic cannula insertion & priming


Omnipod 5 Use in Children and Adults with Type 1 Diabetes: Main Results from the 3-month Pivotal Study


9 |

Study Objective

Primary Outcomes

Primary effectiveness endpoints:

+ Change in HbA1c

+ Time in range (TIR) 70-180 mg/dL

Primary safety endpoints:

+ Diabetic ketoacidosis

+ Severe hypoglycemia

Evaluate the safety and effectiveness of the Omnipod 5 System in people with type 1 diabetes

+ In adults and children aged 6-70 years

+ With user-selected target glucose ranging from 110-150 mg/dL


1 0 |

Omnipod 5 System

Methods

Study Design

+ 241 participants enrolled at 17 institutions across the US

+ Multicenter single-arm outpatient study:

• 14-day standard therapy (ST) phase

• 3-month automated insulin delivery (AID) phase

+ Unrestricted eating and exercise throughout

• Included missed meal bolus and moderate intensity exercise challenges

Inclusion Criteria

+ Children: Age 6 to 13.9 years

+ Adolescents and adults: Age 14 to 70 years

+ All participants:

• Type 1 diabetes for ≥6 months

• HbA1c <10.0%

• Any prior insulin therapy (CSII or MDI)

2 weeks 3 months 12 months

Standard Therapy Continued Use Extension

ClinicalTrials.gov Identifier: NCT04196140


1 1 | CAUTION: Investigational Device, Limited by United States Law to Investigational Use.

Study Pause

+ Pause for 3 months due to software anomaly

+ No adverse events occurred as a result of this issue

+ During pause, participants could continue study system use without automated insulin delivery, or use another form of therapy

+ 99% of participants resumed Omnipod 5 use after the study pause

PauseOmnipod 5 System

Median 44 days Median 49 days

Omnipod 5 System

3 months

1 2 |

Participant Characteristics

mean±SD [range] or n (%)

CharacteristicChildren(N=112)

Adults(N=128)

Age, yr 10 ± 2 37 ± 14

Female, n (%) 60 (54) 78 (61)

Weight, kg 39 ± 13 79 ± 17

Diabetes duration, yr 5 ± 3 18 ± 12

HbA1c, % 7.7 ± 0.9 7.2 ± 0.9

Total daily insulin, U/kg 0.85 ± 0.24 0.61 ± 0.22

MDI users, n (%) 13 (11.6) 23 (18.0)


7.67

7.16 6.99

6.78

6.0

6.5

7.0

7.5

8.0

8.5

9.0

Children (n=112) Adults and Adolescents(n=128)

Primary Outcome: HbA1c after 3 Months of Omnipod 5 Use

1 3 |

1 3 |

* Baseline

Omnipod 5 System

HbA1c (%)

-0.38%

53% of children and 66% of adults achieved HbA1c<7%

with Omnipod 5

*p<0.05; data shown as mean, missing data at follow-up for n=4 in each age group

-0.71%

*


4

5

6

7

8

9

10

11

4 5 6 7 8 9 10 11

En

d O

f S

tud

y H

bA

1c

(%)

Baseline HbA1c (%)

Baseline HbA1c ≥8%N=22, Change = -0.91*

Baseline HbA1c <8%N=102, Change = -0.27*

HbA1c Lower at Follow-up

*p<0.05; data shown as mean

6.86 6.60

8.54

7.63

4

5

6

7

8

9

10

11

Hb

A1

c (%

)

Baseline End of Study

Baseline HbA1c≥8%

Baseline HbA1c <8%

Individual Participant

Reduced HbA1c with Omnipod 5 System Adults



4

5

6

7

8

9

10

11

4 5 6 7 8 9 10 11

En

d O

f S

tud

y H

bA

1c

(%)

Baseline HbA1c (%)


7.14

6.69

8.74

7.56

4

5

6

7

8

9

10

11

Hb

A1

c (%

)

Baseline End of Study

Baseline HbA1c ≥8%N=38, Change = -1.18*

Baseline HbA1c <8%N=70, Change = -0.45*

Baseline HbA1c≥8%

Baseline HbA1c <8%

Individual Participant

HbA1c Lower at Follow-up

Reduced HbA1c with Omnipod 5 Children

INS-OHS-03-2021-00012 V1.01 5 |

52.5%

64.7%68.0%

73.9%

40%

60%

80%

100%

Children (n=112) Adults and Adolescents(n=128)

Primary Outcome: Improved Time in Range with Omnipod 5

1 6 |

*

Standard Therapy

Omnipod 5 SystemTime in Range(70-180 mg/dL)

+3.7 hours/day


*

+2.2 hours/day



64.3%

74.5%

67.3%

73.8%

Standard Therapy First AID Phase Pause Second AID Phase

Study Pause Effect on Outcomes Adults

Time in Range(70-180 mg/dL)

7.23

6.88 6.926.87

Baseline Start of Pause End of Pause End of Study

HbA1c (%) For n=60 participants with HbA1c at all 4 time points

For n=115 participants with CGM data in all 4 phases


53.0%

69.3%

56.6%

67.9%

ST First AID Phase Pause Second AID Phase

Study Pause Effect on Outcomes Children


7.69

7.217.44

7.04

Baseline Start of Pause End of Pause End of Study

HbA1c (%) For n=35 participants with HbA1c at all 4 time points

For n=103 participants with CGM data in all 4 phases

52.5%

60.5%57.1%

65.8%

69.9%68.0%

70.2% 70.1%73.8%

79.1%

40%

60%

80%

100%

6-13.9(n=112)

14-17(n=12)

18-25(n=22)

26-50(n=67)

50+(n=27)

Time in Range Improved Across Age Groups

1 9 |

Standard Therapy

Omnipod 5 System


Age Group (years)

* **

*


+9.7% +13.0% +8.0% +9.2%+15.6%

*


0.22%

2.0%

0.17%

1.1%

0%

1%

2%

3%

4%

<54 mg/dL <70 mg/dL

Reduced Time in Hypoglycemic and Hyperglycemic Ranges Adults

2 0 |

*

Standard Therapy

Omnipod 5 System

32.4%

10.1%

24.7%

5.8%

0%

10%

20%

30%

40%

>180 mg/dL ≥250 mg/dL

*

*

*

-0.08% -0.89% -7.7% -4.3%

*p<0.05; data are median (<54, <70) or mean (otherwise)

PercentTime


2 1 |

0.10%

1.4%

0.23%

1.5%

0%

1%

2%

3%

4%

<54 mg/dL <70 mg/dL

Hypoglycemia Remained Low with Reduced Hyperglycemia Children

2 1 | INS-N/A-08-2020-00003 V1.0

45.3%

19.1%

30.2%

9.6%

0%

20%

40%

60%

>180 mg/dL ≥250 mg/dL

*

*

+0.04% +0.06% -15.1% -9.4%

PercentTime

Standard Therapy

Omnipod 5*p<0.05; data shown as median (<54, <70) or mean (otherwise)

CAUTION: Investigational Device, Limited by United States Law to Investigational Use. INS-OHS-03-2021-00012 V1.0

2 2 |

64.7%

73.9%75.6%

40%

60%

80%

100%

Time in Range (70-180 mg/dL)

0.22%

2.0%

0.17%

1.1%

0.16%

1.0%

0%

1%

2%

3%

4%

<54 mg/dL <70 mg/dL

Optimal Outcomes with Target Glucose of 110 mg/dL Adults

*AID significant compared to ST with p<0.05

Standard Therapy

Omnipod 5+2.6 hours/day

Omnipod 5 at 110 mg/dL target

n=121 at 110mg/dL target and n=128 for other conditions; 110 mg/dL used for 81% of cumulative study time.

*

*

*

PercentTime


Conclusions

+ The Omnipod 5 system was safe and performed well in children and adults with type 1 diabetes when used for 3 months at home:

• HbA1c was reduced to 6.78% in adults and 6.99% in children

• In adults, TIR increased to 73.9%, or to 75.6% when using the 110mg/dL target

• In children, TIR increased to 68.0%

• Time in hypoglycemia was reduced for adults, remained low for children

+ The system remained in Automated Mode for 95% of the 3-month study

+ The majority of participants continued into the 12-month extension phase



Discussion with Dr. Bruce BodeOmnipod 5 Principal Investigator


Q&A

insulet corporation: omnipod® 5 clinical results

Documents