Insulet (PODD) November 16, 2016 Investor Day Questions for Management

Insulet investor day 10:30-3pm EDT, online streaming available

 

FDA investigation

 

  • 1. Have any FDA inspections occurred in 2016 thus far?
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  • 2. If so, what was the result of these FDA inspections?
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  • 3. Are any FDA inspections expected between now and yearend?
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  • 4. Why hasn’t the FDA closed their investigation?
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  • 5. Should investors be concerned what the FDA’s next step will be given the lack of progress PODD has made (i.e. adverse events involving the needle mechanism failures continue to be reported and are increasing) with regard to resolving needle mechanism failures?

 

Patient deaths

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  • 1. Why is a settlement and pay-off associated with the reported patient death that occurred on September 25, 2012?
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  • 2. What were the terms of this settlement?
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  • 3. How often, why and to what dollar value annually has PODD entered into settlements with patients, whistleblowers and others, respectively?
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  • 4. Why did PODD determine it did not need to disclose the patient death that occurred on September 25, 2012 along with the various serious allegations by the whistleblower within its filings with the SEC?
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  • 5. Why did PODD wait 2 full years before filing this FDA Report with the FDA?
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  • 6. There are a variety of FDA adverse event reports that state PODD will follow up once it obtains more information about the patient deaths. What is the latest on these various patient deaths?

 

Product defects

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  • 1. Why have the needle mechanism failures continued for the last 5 years and why can’t PODD resolve this defect?

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  • 2. Why have the PDM failures continued for several years now and why can’t PODD resolve this defect?

 

CC:

 

ir@insulet.com

David.R.Lewis@morganstanley.com

tao.levy@wedbush.com

jwald@benchmarkcompany.com

gchodaczek@brileyco.com

KRose@canaccordgenuity.com

doug.schenkel@cowen.com

bchaynor@feltl.com

rdenhoy@jefferies.com

mike.weinstein@jpmorgan.com

jdjohnson@rwbaird.com

danielle.antalffy@leerink.com

skalia@northlandcapitalmarkets.com

bandrew@williamblair.com

ed.snyder@northcoastresearch.com

Steven.Lichtman@opco.com

brooks.e.west@pjc.com

 

 

 

 

 

 

 

 

 

 

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