Insulet Reports 1Q 2013 Results: New Pod Statement

"We are pleased with the initial launch of the new, smaller and lighter OmniPod in the U.S.," said Duane DeSisto, President and Chief Executive Officer of Insulet.  "Our customers and healthcare professionals have been sharing their positive feedback about the reduced size, ease of use and change to the insulin on board calculation.  Demand for the new OmniPod has been tremendous with referrals and initial shipments up by more than 40% over the last two months as compared to the prior year.  In the coming weeks, we expect to begin converting the existing customer base to the new OmniPod and continue to expect the transition to be completed by the end of the third quarter."

The rest of the report is here.

Update on Tuesday, May 7, 2013 at 10:55AM by Scott Benner

The following is from the May 6, 2013 Insulet Earnings Call. The quote was brought to my attention by the TuDiabetes User, Erik. I then listened to the call to verify the quote as accurate. It can be found 05:47 into the call.

"With this significant uptick in demand, we did make the decision to delay the transition of existing customers for approximately 90 days in order to build additional OmniPod supply. While the manufacturing process continues to improve, we had an unexpected component issue that resulted in lower than planned production in the latter part of Q1. While this component issue was quickly identified, and remedied in conjunction with both Flextronics and the supplier, we determined it most prudent to build inventory and insure that both manufacturing lines were operating efficiently before we commence the transition of over 45 thousand customers to the new OmniPod. At this point, we expect that conversion will start in the next few weeks, and remain confident that nearly all customer will be transitioned by the end of the third quarter."

Health Canada Approves DexCom G4

DexCom announced yesterday at their May 1, 2013 Earnings Conference Call that...

"On the international front, we are pleased to report that we have received approval from Health Canada to begin marketing the G4 system in Canada. Our initial approval is for adults only. However, we expect to file supplements seeking pediatric approval later this quarter. Our distributor in Canada expects to commence a limited launch at the beginning of Q3 with the full launch commencing before the end of Q3"

Congratulations to my Canadian friends who have been patiently waiting to use DexCom's G4 system!

From Stay-At-Home Dad to Published Author and all the Laundry in between

From the Trenton Times. Photo by Christina Izzo 

From the Trenton Times: 

Scott Benner said he had his first introduction to writing books when he was a child in school.

“We used to write them and bind them and then they would go on a library cart and go from class to class,” he said. “That’s the part I really liked — that the book was somewhere else and someone else was reading it.”

Benner, who grew up in Bucks County, continued writing through his teens and early 20s, trying his hand at writing movie scripts and fiction, but he said he found that he was writing stories that were already written.

“I felt that I didn’t have anything to say,” he said. “I felt that if I kept saying stuff that somebody else had already said, either it isn’t valuable or I’m not at a point yet where I should be doing this.”

But after being a stay-at-home dad for 12 years, Benner said he found something to say.

You can read the entire article in today's edition or online here.

If you are in the Central NJ area, please come out tonight at 6:30 pm for my first book signing at the Barnes & Noble in Hamilton, NJ.

Oh Canada, I have new OmniPod info

Over the weekend I received more then a few queries from fellow OmniPodders that live in Canada. All were wondering when they can expect the smaller OmniPod to arrive north of the border. So I tied a tiny electronic note to a digital sparrow and released him into the Internet. This encouraging bit of news is what came back...

"With U.S. FDA approval now in hand, we can move forward with our regulatory filings in Canada. We hope that we would begin selling the new OmniPod in Canada later in 2013." - Brian Roberts, CFO, Insulet

There you have it Canada, I hope that this was the kind of news that you were all hoping for. It's not concrete but Insulet is willing to tie themselves to a date, however vague, and I think that is worth be optimistic about. I'll let you know more when I do.

Oh, you know what, while you're here. I've been wondering this my entire adult life... What's a Canuck? Seriously, is it a bird, plant, slang or none of the above? I need to know, please. Thanks!

New OmniPod Pictures and Information

It's official! The next generation of the OmniPod Insulin Management System has been approved by the FDA!

I've just finished speaking with Sean Gallagher, Senior Director, Marketing for Insulet, person living with type I diabetes and OmniPod user. We spoke for a bit this afternoon and I have some fresh information about the new Pods and PDM to share.

The name remains the same: You won't be wearing the OmniPod G2 or OmniPod Lite. Just good old OmniPod.

Pricing: There will be no price increase for the new system.

Transition: Insulet has been working for "18 months" to make the transition to the new smaller pod "easy" and fast for us the users.

How the upgrade happens: Current OmniPod users will receive an email stating that upgrading is possible. All you have to do is contact them back to get the ball rolling. Sean stresses that the process will be super easy, fast and efficient. They are working hard to make the transition a pleasure.

When? When can I get them?: There is some training of staff, endos and the like that's happening now. Expectations are that those steps will be finished and the new Pods will begin being delivered in the first quarter of 2013. I know you feel like you've heard that before but this time the ball is completely in Insulet's court, they have control, I'd bet anything that this time frame is accurate.

More when: For customers that are currently under warrantee. Your new Pods will arrive after you've exhausted the stock that you have in your home. Upgrades will happen at re-order only.

Any insurance stuff to worry about?: Simply, no. If you happen to be outside of your warrantee there will be some steps to take between Insult and your insurance company but Sean assures me that most of that process will happen on their side of the equation, requiring only a minor amount of effort on your part. The man said, "easy" is their goal, I believe him.

Interesting technical stuff

• The insulin reservoir capacity remains the same even though the pod is smaller.


• I asked Sean, "how did your R&D people accomplish the size reduction?" He responded simply by saying, "they're brilliant!". The slightly more technical reasons however include, the insulin reservoir shape has been changed to an oval and flattened. Plus the new Pods require only three, instead of four batteries because of enhancements that lessened power requirements.


• The new PDM has a dramatically improved stated signal range of five feet, but between you and me, I've seen and used one during FDA required Human Factor Testing... I'd try backing up if I was you.


• The smaller Pods have a new feature called a 'pink slide.' When the cannula deploys correctly, it pushes a piece of pink plastic to be visible through a new, second window on the top of the pod's surface. You can use this together with the regular viewing window for additional confirmation of insertion. - Info and picture added at 5 pm on 12/14 after second conversation with Insulet.

Why the long wait:

I expressed to Sean that the long wait for the newer, smaller, lighter OmniPod made me wonder if they were ever going to see the light of day in the U.S.

Sean indicated that the Human Factor Testing requirement from the FDA was in it's infancy (my word) when they were seeking approval and that both sides lived through a learning curve. He did stress that he genuinly belives that the "process is valuable" and when I asked if it was fair to say that the process provided me (and you) with a better, safer insulin pump, he did not hesitate to say, "yes".

Sean closed out our discussion with two thoughts that I will share.

He hopes, for two reasons, that those of you that may be preparing to begin pumping with OmniPod don't feel as though you should wait for the new Pods to become available. His first point (that I can completely agree with) was simple. The current version is a great device. I can't argue with that. If you start today you will be using a wonderful insulin pump, one that has benefited many including Arden for years. His second point was a reminder that the transition to the new Pods will be so easy that it won't even cause a blip in your day to day life. So there's no reason to wait.

I'm choosing to include his thoughts, that you may read as marketing (and perhaps it is) not just because I believe in the company, but also because I know that Insulet is a small company. I don't know for sure, but I'm willing to guess that they wouldn't do well financially with a less then normal amount of new customers over the next three or so months. That's my honest take on this issue, I make no secret that I'd like Insulet and OmniPod to thrive, it's good for my daughter and for all of you that wear the pump.

Lastly:

Sean wanted all of us to know that he and Insulet appreciate all of our paitence during this long journey. He is thrilled by the reception that OmniPod receives in our community and is touched by the eagerness that the new generation OmniPod is being greeted with. He said, "I am happy and excited to put the new OmniPod into hands".

Now for the pictures, you know you want to see the pictures!

Hi-Res version are available in the Visual Record section of the blog.

Update on Monday, December 17, 2012 at 12:46PM by Scott Benner

I have good news about the new OmniPod for my Canadian friends right here