Memorandum

Dexcom 2Q16 – Record-high sales, non-adjunctive labeling FDA discussions underway; touchscreen receiver filed, new inserter and Android G5 filing imminent; G6 pivotal starting ASAP – August 3, 2016

Executive Highlights

  • Dexcom reported all-time high revenue of $137 million in 2Q16, a very strong 47% year-over-year (YOY) gain on a very challenging comparison to 2Q15. Sales grew 18% sequentially from 1Q16. This marked 15 (!) straight quarters of 47%+ YOY growth.
  • Dexcom estimates it increased US CGM penetration in type 1s by two percentage points in 1H16, equating to ~30,000 new patient adds. Over 60% of new patient adds in 2Q16 were MDI users, flipping Dexcom’s historic 60% pump/40% MDI split.
  • Dexcom is in labeling discussions with the FDA following the very positive July 21 meeting on a non-adjunctive (insulin dosing) claim for G5. The next-gen touchscreen receiver was filed with the FDA in 2Q16. The new inserter and 50% smaller transmitter will be filed with the FDA in the next few weeks. An Android version of G5 Mobile will be filed in 3Q16, putting launch in “late 2016 or early 2017.” The IDE for G6 has been approved, and Dexcom will start the pivotal study “as soon as possible. The Verily partnership is “on track” to launch a first-gen product in 2018.

Dexcom reported 2Q16 financial results yesterday afternoon in a call led by CEO Kevin Sayer. It was a quarter with two major milestones (positive FDA meeting, DIaMonD results), record-high revenue, and many pipeline projects moving ahead. We enclose the top business and pipeline updates below, followed by a pipeline summary.

Financial and Business Updates

1. Dexcom reported all-time high revenue of $137 million, representing a 47% year-over-year (YOY) gain on a very tough comparison to 2Q15. Sales grew 18% sequentially from 1Q16. This marks 15 straight quarters of 47%+ YOY growth (since the launch of G4 in late 2012), though the law of large numbers is kicking in: this was the lowest quarterly YOY growth since 3Q12.

2. Management increased guidance from 1Q16, with 2016 sales now expected in the range of $550 million-$575 million (up from $540 million-$565 million). The new guidance puts YOY growth at 37%-43%, which some analysts characterized as conservative (we wouldn’t disagree): Dexcom is already 45% of the way to the midpoint, sales are usually back-loaded, and the 1H16 saw 53% growth.

3. Dexcom estimates it increased US CGM penetration in type 1s by two percentage points in 1H16, equating to ~30,000 new patient adds (assuming ~1.5 million US type 1s). Management estimated current US CGM penetration in type 1s at 15%-20%, and believes Dexcom has a 70% market share. Over 60% of new patient adds in 2Q16 were MDI users, flipping Dexcom’s historic 60% pump/40% MDI split.

4. Profitability was lower than expected this quarter on the heels of lower gross margin, reflecting the receiver recall. Cash-based net income was $11 million in 2Q16, down 45% YOY from 2Q15 ($20 million) and down 63% from $29 million on previous record high sales in 4Q15. We aren’t reading too negatively into the profitability results, given the one-time receiver issue, the major pipeline investments, and non-cash expenses.

5. Management highlighted the preliminary DIaMonD study results (presented at ADA) testing CGM in MDI users, citing a “1.0%” A1c reduction in the CGM arm (not 0.9% as shown in June). Once the type 2 cohort completes study activities in 3Q16, analyses and publication will follow. Notably, management expects a “very big impact” with payers.

6. Dexcom says it has fixed the major customer service challenges reported in 1Q16. Dexcom’s net promoter score related to customer service and tech support is “back up to 70%.”

7. The call highlighted the positive reimbursement decision for CGM in Germany (announced in June), but any revenue impact won’t come until 2017. Remarks noted the decision only includes systems with alarms, an unstated competitive knock against Abbott’s FreeStyle Libre. Reimbursement in France and/or the UK are a possibility in the second half of 2016.

8. Pharmacy distribution has gone slower than expected, which is disappointing, given the patient and company upside. Dexcom has not been willing to give up the current sensor pricing, while payers want to negotiate discounts. The 10-day wear G6 “may be a time to aggressively go after the pharmacy business.” On a very interesting note, Mr. Sayer said for the first time that Dexcom may opt for a subscription business model.

Pipeline Highlights

9. Dexcom is now in labeling discussions with the FDA following the very positive July 21 meeting on a non-adjunctive (insulin dosing) claim for G5 (8-2 YES vote). As we reported two weeks ago, the focus is now on the training requirements and scope of the post-market study. No timeline was provided on approval, but it sounds like a “WHEN” more than an “IF” question – we would certainly hope so, though we do not think FDA prepared the panel as well as it could have, given what FDA requested itself from Dexcom.

10. Dexcom filed its next-gen touchscreen receiver with the FDA in 2Q16, as expected. We assume a launch could still happen by end of year.  During 2Q16, Dexcom submitted a firmware update for the G5 transmitter and a software update for the mobile app; both will enhance the performance and reliability of the G5 mobile transmitter.

11. The next-gen one-button, automatic G5 sensor insertion device and 50% smaller transmitter will be filed with the FDA in the next few weeks, a slight delay due to the internal resources spent on the FDA panel meeting

12. Dexcom expects to file an Android version of G5 Mobile in 3Q16, putting launch into “late 2016 or early 2017” – a slight delay from the previous plan to firmly launch in the US in 2016. Dexcom does plan to launch Android G5 this fall in “several key international markets.”

13. Dexcom will file the next version of the G5 mobile app before the end of 2016, adding the ability to receive insulin dose data from other devices.

14. The IDE for G6 has been approved, and Dexcom will start the pivotal study “as soon as possible. It will be Dexcom’s largest pivotal ever, with pediatric and adults included in one combined study of ~300 subjects.

15. The Verily partnership to develop a simple, low-cost, disposable CGM sensor is “on track” to launch a first-gen product in 2018. The ultimate vision, a smaller bandage-like sensor, “could be available as early as 2020.” The first feasibility study of the latter will start this fall. Management characterized the Verily sensor as a “homerun” for type 2 diabetes, assuming the product design works out and the cost gets low enough.

16. Mr. Sayer noted “excellent progress” as pump partners Animas, Insulet, and Tandem work to integrate the G5 and G6 sensors. He also highlighted Beta Bionics and Bigfoot Biomedical for taking “truly novel approaches to the development of automated insulin delivery systems.” We certainly concur.

Financial and Business Highlights

1. Dexcom reported all-time high revenue of $137 million, representing a 47% year-over-year (YOY) gain on a very tough comparison to 2Q15. Sales grew 18% sequentially from 1Q16, consistent with seasonality. This marks 15 straight quarters of 47%+ YOY growth since the launch of G4 in late 2012. It also beat the previous high revenue of $131 million (4Q15) handily. With the high base of sales, however, the law of large numbers is starting to kick in: this was Dexcom’s lowest YOY quarterly growth since 3Q12. Still, Dexcom’s ability to grow topline revenue has been impressive: the company generated as much revenue in the past six months as it did in all of 2014. The US business provided 87% of the quarter’s growth on sales of $119 million (48% YOY growth).

Figure 1: Dexcom Quarterly Worldwide, US, International Product Revenue (2Q12-2Q16)

  • The international business brought in sales of ~$18 million in 2Q16, growing 48% YOY (on pace with global and US sales), decreasing 5% sequentially, and driving 13% of the quarter’s overall growth. International sales fell sequentially for the first time since 1Q15, and by the largest margin ever, but Mr. Sayer chalked the decline up to “choppy” distributor purchasing patterns and the mid-summer European vacation schedule. On the whole he was not concerned, as this was the second most successful international quarter for Dexcom, only trailing last quarter’s performance by $1 million. The near-term outlook also looks positive as Dexcom prepares to ramp up sales in Germany, and potentially France and the UK (more below).

2. Management increased guidance from 1Q16, now projecting 2016 revenue in the range of $550 million-$575 million (up from $540 million-$565 million). The new guidance puts YOY growth at 37%-43%. During Q&A, one analyst pointed out that, given the successful first 1H16 (53% YOY growth from 1H15), projected full year revenue implies only ~26%-37% growth for the back half of 2016. CEO Mr. Kevin Sayer replied that Dexcom is generally conservative with respect to guidance, and that hitting the $575 million mark (“a big number”) would be a massive accomplishment for the company. Even if Dexcom does reach $600 million, it will only be a ~4% overachievement, which management does not believe warrants revised guidance. Mr. Sayer also alluded to the increasing base, suggesting that YOY growth will naturally slow as sales continue to rise. We’d also point out the 4Q16 YOY comparison will be very difficult to the blowout 4Q15.

3. Dexcom estimates it increased US CGM penetration in type 1s by two percentage points in 1H16, equating to 30,000 new patient adds (assuming ~1.5 million US type 1s). Management estimated current US CGM penetration in type 1s at 15%-20%, and believes Dexcom has a 70% market share (according to “independent data,” which we assume is dQ&A; contact Richard Wood). Dexcom’s estimated global patient base was ~140,000-150,000 as of December 31, 2015, with an estimated 75%-80% in the US (~113,000) and 20%-25% (~33,000) residing outside the United States. With this in mind, the 30,000 new patients in the US represents an ~30% underlying expansion in the patient base in 1H16, which sounds about right given topline 53% YOY revenue growth thus far.

  • Over 60% of new patient adds in 2Q16 were MDI users, flipping Dexcom’s historic 60% pump/40% MDI split. This aligns more with the split of the overall type 1 population and indicates Dexcom is expanding beyond intensively managed pumpers. Management said the “CGM first” message is finally resonating. We assume the move to G5 mobile has contributed in a big way to this MDI uptake (less stuff to carry), and certainly, the DIaMonD study once published should drive greater use in MDI too. Of course, Dexcom is agnostic as to where the users come from, since CGM can be used regardless of insulin delivery method.

4. Profitability was lower than expected this quarter on the heels of the receiver recall. Cash-based net income was $11 million in 2Q16, down 45% YOY from 2Q15 ($20 million) and down 63% from $29 million on previous record high sales in 4Q15. The higher-than-expected net loss of $20 million increased five-fold from $3.7 million in 2Q15, attributed to: (i) higher warranty expenses and inventory write-downs associated with the receiver recall; and (ii) “to a lesser extent, typical new product performance issues related to the launch of the G5 transmitter.” Gross margin declined to 62%, down a few points from 1Q16 (65%) and down nearly ten points from 2Q15 (71%). Management said warranty costs as a percentage of sales should begin to decline in 3Q16 and stabilize. Gross margins are expected to improve to the mid-to-upper 60% range in 2H16.

  • Dexcom is clearly investing in the pipeline in a big way, and combined with significant non-cash expenses ($32 million, mostly share-based compensation), we aren’t reading too negatively into the profitability results. The balance between topline and bottom line growth is very tough, but we think management is striking it correctly, all things considered. The receiver recall was a setback, but Dexcom handled it well. Dexcom is generating cash each quarter (up $10 million from 1Q16) and the business model clearly works as it stands. The biggest threat for Dexcom may be if pricing comes down significantly, particularly with competitive products like FreeStyle Libre, though we think volume is only going up, and that will bode well for the company.

5. Management highlighted the preliminary DIaMonD study results (presented at ADA) testing CGM in MDI users, citing a “1.0%” A1c reduction in the CGM arm (not 0.9% as shown in June). Once the type 2 cohort completes study activities in 3Q16, analyses and publication will follow. Management expects a “very big impact” with payers: “We have a reasonable cost alternative for intensive management of diabetes. We can take cost out of the system by using MDI and CGM.” We’d note that the slides presented at ADA actually listed a “0.9%” reduction in A1c in the CGM arm; in a follow-up conversation, Dexcom’s Dr. David Price told us the reduction was actually 1% with rounding, and the publication will reflect this fact. As a reminder, only results from type 1s were presented at ADA, and we’ll be interested to see how the type 2 results compare. In addition to payer conversations, DIaMonD data will of course be helpful for physicians who only prescribe CGM to pump patients. DIaMonD has a second phase where patients will transition to using a pump, with results expected in 2017. See our complete coverage from our ADA report.

6. Dexcom has fixed the major customer service challenges reported in 1Q16. Call wait times and calls answered per day have seen a “major improvement,” and Dexcom’s net promoter score related to customer service and tech support is “back up to 70%” (not cited, but we assume it is from dQ&A; contact Richard Wood). As we noted last quarter, the challenges stemmed from the larger patient base, the complicated launch of G5 mobile (Bluetooth problems, app, shorter transmitter life), and the receiver recall. Dexcom added and trained more customer service team members, implemented an IT efficiency project, and added a new phone system. This certainly underscores the challenges of launching a class III medical device on the phone, and the barriers to entry for startup companies trying to commercialize devices in diabetes.

7. Management highlighted the positive reimbursement decision for CGM in Germany (announced in June), but any revenue impact won’t come until 2017. Remarks noted the decision only includes systems with alarms, an unstated competitive knock against Abbott’s FreeStyle Libre. A couple of procedural items await ratification from the German government, after which Dexcom will need to negotiate pricing. Then it will have to work out individualized contracts with regional payers, much like the regional Medicaid system in the US. It’s certainly not a flip of the switch! Dexcom acquired its exclusive distributor in Germany, Switzerland, and Austria in May (Nintamed), a clear investment in the upside.

  • Reimbursement in France and the UK are still possible 2H16 events, and Dexcom has established a targeted, direct sales team in the UK. We’re not sure if the latter was another way of saying the EU headquarters in Scotland has opened, which was “very close” as of 1Q16. As a reminder, Dexcom already has reimbursement in Sweden, Switzerland, and the Netherlands.
  • Mr. Sayer on the importance of growth in Europe: to continue growing at the rates we're growing at and the growth that we project, we have to have wins like this. They just have to happen. So we plan for them, and we plan around them, and things fall into place. That's how we look at it for now. We're very optimistic about it, not much for the rest of this year but kicking into next year we think Germany can be very big.”

8. Pharmacy distribution has gone slower than expected. Dexcom has not been willing to give up the current sensor pricing, while payers want to negotiate discounts. The 10-day wear G6 “may be a time to aggressively go after the pharmacy business.” Mr. Sayer said Dexcom has good deals with many payers via DME right now, and from a revenue perspective, it doesn't make a lot of sense to give up a lot of pricing just to move over to the pharmacy channel. The 3Q15 goal to move 70% of the business to the pharmacy benefits channel over a three-year period sounds less likely at this stage, though it was not mentioned today. On the plus side, management may revisit this issue with the 10-day wear G6 sensor, which may allow Dexcom to give payers lower per-sensor pricing but maintain margins [Right now, Dexcom is currently paid on a per-day basis for sensors: $10-$10.75 per day, or $70-$75 per seven-day sensor. With the 10-day wear G6, production cost will be similar, but Dexcom could give some pricing back to payers in exchange.] Cost will also come down with cheaper and/or disposable transmitters.

  • For the first time, Mr. Sayer said the business model may change over time, where Dexcom “might get into a subscription-type model that's delivered through the drug store.” We think this makes perfect sense – it should be easier for patients to obtain sensors, align with where diabetes technology and healthcare seem to be heading (service models, bundled payments), and may even give payers a better deal (e.g., less upfront cost wasted if a patient doesn’t use the system).

Pipeline Highlights

9. Dexcom is now in labeling discussions with the FDA following the very positive July 21 meeting on a non-adjunctive (insulin dosing) claim for G5 (8-2 YES vote). As we reported two weeks ago, the focus is now on the training requirements and scope of the post-market study. No timeline was provided on an approval, but it sounded like a “WHEN” more than an “IF” question. The FDA dialogue was characterized as “open,” “transparent,” and “interactive.” Similar to past updates, this label was positioned as a major competitive advantage (“We will be first”) and setting the tone for the future of the field: “We have an opportunity to change the landscape, and to set standards to make us the leader in the landscape for some time.” CEO Kevin Sayer said that eliminating fingersticks has always been Dexcom’s goal, and this label is the “first step” in that process. Of course, this label also has major implications for Abbott’s factory calibrated FreeStyle Libre (FDA submission expected in the “near future,” with an ambitious goal of launching in 1Q17; per Abbott 2Q16).

  • Mr. Sayer highlighted some of the training questions that the FDA panel raised earlier this month: (i) Is Dexcom responsible for providing specific insulin dose adjustment guidelines based on trend arrows (e.g., double up arrow = +30% to dose), or is this the responsibility of physicians/professional associations?; (ii) do different patient sub-groups need different training on this labeling (adults, pediatrics, seniors)? (iii) What training do healthcare providers need, and are different materials needed for endocrinologists and educators vs. PCPs? Regarding the training discussion, management said, “We don't believe it's going to require a whole lot – it's going to slow us down, but we do need to get this training material really knocked out and revised before we can launch.” We would certainly love to see, as we’ve said for some time, HCP reimbursement increase.
  • Some interesting “philosophical” questions are also coming upfor instance, “what is the future of adjunctive CGM once non-adjunctive labeling is established?” Will the field bifurcate into sensors approved for insulin dosing (more accurate) and those not approved for dosing (less accurate, but presumably a better form factor)? Dexcom has implied this in previous updates dating back to the Verily partnership, and it makes sense in our view as Dexcom looks into the type 2 population not on insulin. We’re not sure if the Verily sensor will maintain the accuracy of G5; we assume not.
  • No timing on Medicare coverage was given today, but Dexcom’s post-FDA meeting call two weeks ago put it in 2018 or later. Remarks were very clear that this label is THE gating factor to Medicare coverage, but Dexcom will only approach CMS at the “appropriate time.” That seems reasonable – we believe patient advocates are very keen to contribute and we hope they receive appropriate guidance.
  • The FDA has not required an automatic sensor shutoff at this point, though it is a concern with an insulin-dosing claim. Dexcom is being very thoughtful about this, recognizing many patients extend the sensor life to save money. Said Mr. Sayer: “There are a number of ways we could do an automatic shutoff, if the FDA required it. Right now, FDA has not required that from us. As we learn more about the performance of a non-adjunctive claim, we may revisit it with FDA over time. It’s a good question: if someone is wearing a sensor on day 24, they get a bad reading, and dose insulin, is that our fault or the patient’s fault? Right now, our patients are very adept at determining when the sensor is not working. We have not been asked to shut off the sensor at this point in time, but we will evaluate it with future technology. We will be fair with patients no matter what we do. In all candor, we would make it right with patients in the pricing models to make sure they are not harmed. We know how important it is; the cost of the technology is something we will always balance. This is something we’ve been very thoughtful about. In terms of future products, there is not a whole lot of reasons not to turn off a two-week sensor. But at seven days right now, our patients say it lasts longer than seven days. One investigator said week two is actually better than week one for some of his patients. We will explore this with the FDA and consider it over time.”

10. Dexcom filed its next-gen touchscreen receiver with the FDA in 2Q16 (as expected). We assume a launch could still happen by end of year. This receiver will be more durable (i.e., less susceptible to wear) and offer a user interface in line with the G5 mobile app. To address the receiver speaker malfunction, Dexcom has also received FDA approval for a more robust speaker component for the current receiver; the company is planning production now, meaning it is a more near-term fix than the new touchscreen receiver.

  • During 2Q16, Dexcom submitted a firmware update for the G5 transmitter and a software update for the mobile app; both will enhance the performance and reliability of the G5 mobile transmitter. This is the first we have heard of this submission, and we assume it will improve Bluetooth connectivity and reliability, which has been an issue for some G5 users (e.g., missed data when the phone is nearby). We also hope it improves the battery life of the G5 transmitter, which lasts three months to the day without wiggle room in our experience. Clearly, the learning curve on moving things to the phone is steeper than many imagined. At Keystone two weeks ago, Dexcom VP Jake Leach said an enhanced G5 app will launch “as soon as possible,” adding backfill of up to three hours of missing data when the phone and transmitter are separated (e.g., when showering) and a mute switch override (e.g., to enable hearing the low alarm when the phone is on silent mode) – we assume this is part of this updated transmitter/app submission.

11. The next-gen one-button, automatic G5 sensor insertion device and 50% smaller transmitter will be filed with the FDA in the next few weeks, a slight delay due to the internal resources spent on the FDA panel meeting – a good R&D tradeoff, given the upside from the non-adjunctive claim. Previously this inserter was expected to launch by the end of 2016, meaning Dexcom could still hit the timing if things go very well at the FDA. The 97-patient accuracy study of the insertion device was completed in April. This pipeline project requires a major manufacturing change, but it is unquestionably needed to improve the patient experience from the current syringe-like insertion device.

12. Dexcom expects to file an Android version of G5 Mobile in 3Q16, putting launch into “late 2016 or early 2017” – a slight delay from the previous plan to firmly launch in the US in 2016. Dexcom does plan to launch Android G5 this fall in “several key international markets.” Getting G5 Android out in Europe is critical for keeping up with Abbott’s FreeStyle LibreLink Android app, which has now officially launched in Sweden, the Netherlands, Germany, Italy, and the UK (more countries expected soon). Medtronic’s Guardian Connect standalone, Bluetooth-enabled CGM will launch in Europe in August-October 2016, but like G5, it is only on Apple devices to start.

13. Dexcom will file the next version of the G5 mobile app before the end of 2016, adding the ability to receive insulin dose data from other devices. We’d note several devices are coming soon that will send insulin data to the phone, including Tandem’s t:slim X2 with G5 integration (launch expected in mid-2017, per Tandem 2Q16), Insulet’s next-gen OmniPod PDM and mobile app (FDA filing “later in 2016,” per Insulet 1Q16), and Companion Medical’s Bluetooth-enabled InPen (FDA cleared, launching in 2017). It will be a major win for patients to see insulin-on-board data alongside CGM data, particularly as Dexcom moves to non-adjunctive labeling.

14. The IDE for G6 has been approved, and Dexcom will start the pivotal study “as soon as possible.” It will be Dexcom’s largest pivotal ever, with pediatric and adults included in one combined study of ~300 subjects. Patients will have three in-clinic days to measure the accuracy of the G6 sensor, similar to previous studies. The pivotal timing is consistent with the 1Q16 estimate to start in “late 2Q16 or early 3Q16.” We assume this puts a G6 launch in the mid-to-late 2017 timeframe, though management did not comment on this.

  • In line with expectations, G6 will be 10-day wear, require one calibration per day after startup, block acetaminophen, and maintain performance consistent with G5 (even with the reduced calibration scheme). The sensor will use the new applicator and touchscreen receiver (see above).

15. The Verily partnership to develop a simple, low-cost, disposable CGM sensor is “on track” to launch a first-gen product in 2018. The ultimate vision, a smaller bandage-like sensor, “could be available as early as 2020.” The first feasibility study of the bandage-like sensor will start this fall. This was the most specific timing update on both products we have heard since the partnership was announced, a nice vote of confidence that things are moving along. We’d note that the timing for the second-gen product, “as early as 2020,” is a bit back of the initial partnership goal to commercialize “within five years” of 2015.

  • Management characterized the Verily sensor as a “homerun” for type 2 diabetes, assuming the product design works out and the costs get low enough: “The one thing that we have learned, and what we've spent more of our efforts on in the type 2 market over the past several months, is just seeing how this technology will work. And let me tell you, type 2 patients, even those not using insulin, when given this feedback, learn what to do with their health and learn how to take care of their diabetes. It’s a win. If we can get the cost structure the way we want to and the product the way we want it configured with our partners at Verily, we think this is a homerun. The distribution will be every bit as tricky as the technology, and we're getting the technology there first.” [This came in response to an analyst question on sales channels long-term.]
  • There is no question that Dexcom is “all in” on this partnership, and it must be successful to remain competitive in a quickly evolving glucose sensor landscape. As a reminder, Dexcom expects to spend an additional $40 million in 2016 on four key strategic initiatives, one of which is the Verily partnership (the other three initiatives are data analytics capabilities, international expansion, and a new manufacturing facility in Arizona). Per the deal terms announced last August, Dexcom paid Google Life Sciences (now Verily) $35 million upfront in Dexcom stock (very smart), with a further $65 million in milestone payments (cash or stock) and royalties in the mid/high single digits (once annual product sales exceed $750 million).

16. Mr. Sayer noted “excellent progress” as pump partners Animas, Insulet, and Tandem work to integrate G5 and G6 sensor. He also highlighted Beta Bionics and Bigfoot Biomedical for taking “truly novel approaches to the development of automated insulin delivery systems.” These partnerships are a total victory for Dexcom, contributing additional revenue and sticky patients. It will be interesting to see how automated insulin delivery augments sales as Dexcom simultaneously ramps up efforts to appeal to MDIs. Will automated insulin delivery be the killer app for CGM? What fraction of type 1 will choose one of these systems in the coming years? Will AID follow a slow adoption curve, or will it go faster than expected?

Sensor and Software Pipeline

Pipeline Product

Timeline

Non-adjunctive label claim (insulin dosing)

Labeling discussions underway with the FDA. Positive 8-2 vote at advisory panel meeting on July 21.

Touchscreen receiver

Submitted to FDA in 2Q16.

Android G5 app

FDA submission in 3Q16, launch in late 2016 or early 2017 in US. International launch in several key markets in Fall 2016.

Next-gen one-button insertion system, 50% smaller transmitter

FDA submission in 3Q16.

Enhanced G5 app with ability to receive insulin dose data from other devices

FDA submission before the end of 2016

G6 sensor

New sensor and algorithm with 10-day wear, one calibration per day after startup, insulin dosing claim, acetaminophen blocking, predictive alerts

 

IDE approved. Pivotal study to commence “as soon as possible” (we assume in 3Q16). Pediatric and adults included in one combined study of ~300 subjects, three in-clinic days.

Verily [Google Life Sciences] partnership

Simple, low-cost, disposable, 10-14 day sensor system the size of penny integrated into an advanced data analytics platform.

First gen product to launch in 2018.

Second-gen, bandage-like sensor “could be available as early as 2020.” First feasibility study in fall 2016.

Automated Insulin Delivery Partner Pipeline

Animas

Hypoglycemia-Hyperglycemia Minimizer with Dexcom G5 CGM

 

Pivotal study to begin enrolling in 4Q16, launch by November 2017-May 2018.

Insulet

Next-gen OmniPod PDM with G5 app integration

Hybrid closed loop (Mode AGC algorithm)

FDA 510(k) submission later in 2016
 

Clinical trials starting later in 2016, in market in late 2018

Tandem

t:slim X2 with Dexcom G5 integration

Predictive low glucose suspend

Hybrid closed loop (TypeZero algorithm)

 

 

FDA submission by end of 2016. Launch in mid-2017

Pivotal trial in 1Q17, launch in 2017

Pivotal trial in 2017, launch in 2018

Bigfoot Biomedical

Automated insulin delivery system with Dexcom CGM, Asante pump, and smartphone app

First clinical trial underway. Pivotal study in 1H17.

Beta Bionics

Bionic Pancreas dual-chamber iLet with integrated Dexcom CGM

Bridging study in 4Q16, pivotal study starting in 2Q17, FDA submission of insulin-only system by end of 2017.

 

-- by Adam Brown, Brian Levine, and Kelly Close