Memorandum

CeQur acquires J&J’s Calibra Finesse (OneTouch Via) bolus patch device! US launch expected in mid-2019 – July 17, 2018

Executive Highlights

  • In a major positive for CeQur, the European insulin delivery start-up has acquired Calibra Finesse (One Touch Via) from J&J, the highly-anticipated three-day-wear, bolus-only (2-unit), 510(k)-cleared, super slim disposable insulin patch device. A US launch is expected in mid-2019 via pharmacy distribution (a big positive) and CeQur’s own US sales force. It will launch under a new name.

  • The Calibra device is already FDA-cleared with a very broad label: subcutaneous bolus insulin delivery in adults requiring insulin – both type 1 and 2. CeQur will immediately begin transferring manufacturing equipment from the existing OneTouch Via plant in Puerto Rico to a “world-class” undisclosed contract manufacturer. No new FDA submission is needed, and J&J has already done some legwork with payers.

  • We believe Calibra’s unparalleled , slim on-body profile and simplicity has strong potential to make mealtime insulin more convenient, both for MDIs (subtracting three mealtime injections per day) and for transitioning basal-only users to easily add mealtime insulin. This news follows largely positive ADA results in a 44-week RCT vs. pens (1.6% A1c reduction, strong HCP & patient preferences). At its 2016 Medical Device business review, OneTouch Via was pegged as a ~$1 billion global opportunity! We believe that was actually an underestimate and we perceive the opportunity for better insulin delivery for patients as even larger, given the enormous number of people that would benefit from bolus insulin but do not currently take it. Indeed, we see Calibra as market-expanding rather than taking business away from other insulin delivery companies or even from BD – it is a far larger population that would benefit from bolus insulin than currently takes it and we believe the market is ready for this expansion (and that it will not get it from just pens and/or syringes though that market is in growth mode also, particularly with Sanofi’s new mealtime biosimilar Admelog).  

  • This acquisition of Calibra gives CeQur a widely-praised, FDA-cleared, simple mealtime insulin delivery patch to complement its basal-bolus PAQ device. PAQ’s FDA submission is now expected in 4Q18, with a US launch expected in ~2020-2021 (~12-18 months post-Calibra’s launch). PAQ is running ~3-4 years behind schedule, as CeQur has had to work on its manufacturability for high volume/low cost. CeQur is not the acquirer we initially expected, but we think Calibra is an outstanding fit in the company’s portfolio.

  • With this news, J&J is officially out of the diabetes device business, following Animas’ shutdown last October and the completed ~$2.1 billion sale of LifeScan to Platinum Equity in June. J&J originally acquired the Calibra device in 2012 (price not disclosed) – boy has this device been a long-time coming!

  • There is no information on acquisition price/deal terms but we are assuming CeQur got a beyond-great deal given J&J’s decision not to serve patients who need diabetes devices. We assume J&J management is very disappointed it did not move into CGM as advised over the last decade by various managers. We ultimately see the CGM business growing larger than the traditional blood glucose monitoring business. Our team is speculating that CeQur paid between $5 million and $20 million for Calibra – of course, this is pure speculation.

    Minutes ago, CeQur announced huge and unexpected news: acquisition of J&J’s OneTouch Via/Calibra Finesse, the slim three-day-wear, bolus-only, 510(k)-cleared disposable insulin patch device. A US launch is expected in mid-2019 under a new product name, with pharmacy distribution (a major positive unlike most traditional pumps) and likely Medicare reimbursement. CeQur will build its own US sales force targeting high insulin-prescribing healthcare providers and areas with good reimbursement. Wow!

    We are incredibly happy that Calibra will come to market, as enthusiasm from patients and healthcare providers remains sky high – particularly following the very positive data at ADA 2018 (see below; -1.6% A1c reduction; n=278; 62 sites). We believe Calibra’s super slim profile, tremendous simplicity (squeeze the on-device buttons for a two-unit bolus), 200-unit capacity, no-electronics mechanical design, and pharmacy distribution could appeal to a very wide range of insulin users – both for simplifying mealtime insulin in MDIs (subtracting three injections per day) and for transitioning basal-only users to add mealtime insulin. Notes IDC’s renowned Dr. Rich Bergenstal in the press announcement, “Results from the Calibra clinical study were quite impressive, showing that the device provides an easy way for patients to deliver bolus insulin at mealtimes...” We agree!

    As noted, the transaction price was not disclosed, but includes “select assets” from J&J, including OneTouch’s Via manufacturing equipment and a worldwide license to commercialize the device; the US is the initial focus. Between now and mid-2019, CeQur will transfer manufacturing equipment from the existing OneTouch Via plant in Puerto Rico to a “world-class” contract manufacturer. The Calibra device is already FDA-cleared with a very broad label (subcutaneous bolus insulin delivery in adults requiring insulin), and the manufacturing move will not require a new submission (no design changes) – great news for CeQur. J&J obviously did serious legwork on the reimbursement, market research, and packaging fronts, which will clearly help CeQur transition quickly from an R&D-stage to a commercial-stage company by mid-2019. CeQur has ~18 months of runway following $100 million in Series C financing in September 2015.

    Disappointingly, J&J would not give up the great name “OneTouch Via” in the deal, meaning CeQur will launch the device under new branding. We assume some/many of the J&J employees will move over to CeQur, but these contracts are not formally part of this deal.

    This acquisition is a tremendous coup for CeQur, who obtains a widely-praised, FDA-cleared, simple mealtime insulin delivery patch to complement its much-delayed basal-bolus PAQ insulin infusion device. PAQ’s FDA submission is now expected in 4Q18, with a US launch expected in ~2020-2021 (~12-18 months post-Calibra’s launch, and ~three to four years behind schedule). CeQur’s two-device portfolio will now offer flexibility for those that wish to stay on a once-daily basal injection and use Calibra for mealtime doses, or those who want one device (PAQ) for both basal-bolus insulin. We see strong market segments for both. Since the launches will be staggered, CeQur will also gain valuable, near-term commercial experience launching Calibra next year.

    Notably, both Calibra and PAQ can target type 1 or type 2, and both will launch with pharmacy distribution – a unique portfolio that could also set up CeQur for a future acquisition by companies like BD, Insulet, Medtronic, etc. We note differences between both devices and target markets below.

    As a reminder, J&J originally acquired the Calibra device in 2012 (price not disclosed), and Calibra received its first FDA clearance for the Finesse in 2010 followed by subsequent clearances in 2012 and 2017 – this device has been a LONG time coming, and one we believe could drive meaningful glycemic and quality of life improvements for many insulin users. At its 2016 Medical Device business review, OneTouch Via was pegged as a ~$1 billion global opportunity (!), and in Q&A, management shared a ton of excitement for potential in BOTH type 1 and type 2.

    See more details below on this outstanding news, including discussion of the target market for Calibra, device specs for Calibra and PAQ, a review of Calibra’s data from ADA, possible pipeline additions, and Close Concerns’ questions.

    • With this news, J&J is officially out of the diabetes device business. It first announced in January 2017 it was exploring strategic options for LifeScan/Animas/Calibra, followed by Animas’ shutdown last October and the completed ~$2.1 billion sale of LifeScan to Platinum Equity in June. In retrospect, J&J had many awesome components to build a compelling insulin delivery device ecosystem – it could have had Calibra Finesse, a first-to-market hybrid closed loop with Dexcom/Animas, and BGM-driven insulin titration with LifeScan. It unfortunately could not execute on any of these fronts.

    • The US will be CeQur’s major focus for now and perhaps ADA 2019 in San Francisco will be the target launch for the long-awaited Calibra device. This is different from its original plan, which expected an initial launch of PAQ in Europe, followed by the US. Considering CeQur is based in the US (Massachusetts), we think a US focus is a sound strategy before expanding overseas – especially with a faster-moving FDA than even few years ago.

    Who is the target market for Calibra’s Finesse?

    • In speaking with the CeQur team, the bolus-only Calibra Finesse has at least two clear target markets: (i) current basal-bolus MDI users, who would use the three-day-wear Calibra device for mealtime doses, and then take a once-daily basal; and (ii) current basal-only users with type 2 who are adding mealtime insulin. We agree both are critical markets and groups in serious need of more options. While Insulet’s Omnipod continues to see uptake in group #1 (~80% of its new users), it is type 1-focused and we like that Calibra is less expensive, much lower profile on the body, and less complicated. (The clear tradeoff from a full-featured pump is less customization (only two-unit boluses) and the need to still take a basal insulin.)

      • Per the 2017 FDA summary letter, the “OneTouch Via On-Demand Insulin Delivery System is indicated for the subcutaneous bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.” This is a huge asset for Calibra, since it applies to both type 1 and type 2 and is an extremely broad label. Of course, access to the device will ultimately rest on payers; luckily, Calibra shouldn’t have prior authorizations, since it will be focused in the pharmacy channel.

      • Over time, we wonder if Calibra could also find a market in once-weekly GLP-1 users that need a mealtime insulin – could Trulicity or Ozempic users that need an extra mealtime push benefit from adding bolus insulin in Calibra at meal time?

    • What about type 1 vs. type 2? J&J was of course pushing and marketing Calibra for type 2s, though it’s clear to us that many type 1s might like the device. It will be fascinating to watch this play out once it is on the market.

      • This reminds us of FreeStyle Libre, which was oft-positioned as a type 2 device, but has seen more significant adoption in type 1. The ability to market LESS of something – less fingersticks for Libre, less injections for Calibra – is obviously a very strong pitch in type 1s.

    • The CeQur team told us payers are positive on Calibra thus far: “We’ve talked to payers about this concept and they are very favorable. A lot of payers see the challenge (in mealtime insulin); they know the data. They are challenged and need help.”

      • J&J had signed contracts with a number of payers for Calibra, but once divestment was on the table, those contracts lapsed. CeQur will need to go back and re-establish these contracts, which should be much easier than starting them from scratch.

    • CeQur believes that Medicare coverage should also be possible for Calibra at launch. The team still has to talk to CMS, but Valeritas’ 24-hour basal-bolus V-Go has set a “strong precedent” for coverage in this area. CeQur shared that V-Go is approximately $331 per month for therapy (WAC price of ~$11 per 24-hour device); we’ll be interested to see where Calibra is priced on a per-day basis.

    • At its 2016 Medical Device business review, J&J cautiously avoided the terms “patch” or “pump,” calling the Via a “discreet, wearable, on-demand, mealtime insulin delivery solution”like FreeStyle Libre, the clear goal was to create a new category. We think this is very smart, given the goals to appeal far more broadly then traditional pumps. For payers, the clear value proposition is better insulin adherence, fewer missed doses, much more discretion enabled, and a lower cost. The slide cited 2010 Diabetes Care data that 57% of type 2s skip mealtime insulin doses on a consistent basis – much of this is due to stigma. Other comments from that day:

      • “One Touch Via is such a unique product and a really unique opportunity. There are current codes that are sufficient for reimbursement. We think Via offers an opportunity, to insurers to improve compliance to mealtime and snacking dosing. Today, we are in clinical trials to prove just that, and we’re also working with payers to figure out how to use Via as a vehicle to improve compliance and improve patient outcomes.” – J&J 2016 Medical Device business review

      • “This is a new market creation opportunity that this mealtime insulin, on-the-go, anytime, anywhere delivery device should create. There are 57%-60% skipping mealtime or snack time insulin dosing – this is an enormous market opportunity. That figure is limited to expansion with OneTouch Via: the opportunity we can create globally with the launch of that product. We think of durable pumps for people with type 1 diabetes. There is low penetration, with ~30% of people with type 1 diabetes using durable pump. OneTouch Via will be for type 1 or type 2 insulin using patients. That’s the MDI market and people on pens, from what we’ve found in our patient experience data. Dr. Brian Levy, one of our endocrinologists, is the doing clinical data and experience studies, and patients really prefer this wearable, discreet, on-demand mealtime delivery device as a superior experience for them. – J&J 2016 Medical Device business review

      • “For the patient population, it is largely type 2, but people with type 1 diabetes will want this product too – even those on pumps. It is such a unique market creation opportunity: a discreet, bolus only, device for better managing diabetes. So it is largely type 2, but we’re going to see type 1s and type 2s are both interested. – J&J 2016 Medical Device business review

    Calibra, PAQ, and V-Go Product Feature Comparison

    Company/Device

    Details

    Status

    Calibra Finesse

    -Three-day wear
    -Fully disposable, no electronics

    -Very low profile design
    -Bolus-only (2 units)
    -Reservoir max: 200 units
    - Manual fill

    Expected US launch in mid-2019

    Valeritas V-Go

    -24-hour wear
    -Fully disposable, no electronics
    -Basal: 20, 30, 40-unit/day versions
    -2-unit boluses (36 units max/day)
    -Reservoir max: 76 units/day

    - Manual fill

    Commercially available in the US; record 1Q18 revenue of $6 million 

    CeQur PAQ

    -Three-day wear
    -Combination disposable + reusable with electronics
    -16, 20, 24, 32, 40, 50, 60-unit basal options
    -2-unit boluses
    -Reservoir max: 330 units

    - Manual fill

    FDA 510(k) submission in 4Q18, with potential 2020-2021 launch (~12-18 months following Calibra Finesse)

     

    Q: What is taking PAQ so long to get to market? A: Design for scalability and low-cost manufacturing

    • PAQ’s FDA submission has been held up as CeQur has focused on scalability and low-cost manufacturability. An FDA submission is now expected in 4Q18, placing potential FDA clearance around mid-2019 if things go well. From there, CeQur will need to scale up PAQ’s manufacturing, as the current line can only support 5,000 patients. Management expects PAQ will come to the US market ~18 months following the bolus-only Calibra device, putting a US launch in ~2020-2021. PAQ’s launch is running more than three years behind the schedule laid out in September 2015 when CeQur raised an impressive $100 million. At the time, management hoped for a limited 2016 EU launch followed by a full-scale US launch expected in 2017.

    • CeQur now believes it has PAQ’s design and manufacturing at a point where it is “working beautifully.” Following FDA submission and the first questions back from the FDA, it will decide whether to spend the money on larger manufacturing lines for PAQ (a significant ~$25 million); it won’t spend the money before hearing back from FDA. Obviously commercializing simple, highly manufacturable, low-cost insulin delivery devices is no easy task –it has taken Insulet more than a decade to get to its current level (still not profitable), and Valeritas has also had a slow ramp.

    Thoughts from IDC’s Dr. Rich Bergenstal

    “At IDC and Park Nicollet in Minneapolis, we see many individuals with type 2 diabetes on oral agents and basal insulin with elevated A1cs that we might consider moving to basal-bolus insulin but wonder, ‘is it really possible to get excellent glucose control without too much hypoglycemia and maintain that for a year?’ That’s what was appealing about participating in the multicenter study comparing the Calibra (now CeQur) three-day bolus insulin patch to an insulin pen to deliver pre-meal rapid acting insulin. It was nice to have input into the study so we could confirm it was important to treat both groups with the same intensity and collect not only A1c but also 7-point SMBG profiles and CGM (in a subset) along with PROs and patient preference.

    Using a simple glucose log book with algorithms built in to adjust bolus and basal insulin to match the glucose patterns, we ended up seeing some of the best glucose control I have ever seen in a group starting with an A1C of 8.6% already on insulin. Not only was the six-month and almost 12-month A1c at 7%, but more impressively to me was how the patients individualized their Lantus dose to go to bed at 130 mg/dl and wake up at 130 mg/dl, and also adjust the bolus insulin so pre-meal glucoses stayed at 130 mg/dl and post meals glucoses went up only 10-15 mg/dl (on average). My conclusion: Adjust basal and bolus insulin on a regular basis according to glucose patterns and diabetes management can be excellent (excellent time-in-range with minimal time in hypoglycemia – my standard definition of excellent management). Patients can deliver the insulin many ways but our study volunteers and healthcare professionals preferred and were more satisfied delivering multiple bolus injections using the three-day bolus patch.

    ADA 2018: Calibra Finesse (OneTouch Via) Clinical Study Results

    • At ADA last month, we saw results from an impressive 62-site, 44-week clinical study comparing OneTouch Via (Calibra Finesse) to insulin pens in 278 people with type 2 diabetes. See the coverage replicated below. In our call, CeQur management noted the high patient/HCP satisfaction, and the highly robust ~1.6%-17% A1c reductions in both arms of the study. As we noted at the time, the trial was in many ways a test of insulin dosing titration, as the MDI arm did spectacularly well.

    OneTouch Via (Calibra Finesse): Comparing Patch vs. Pen Bolus Insulin Delivery in Type 2 Diabetes Using Continuous Glucose Monitoring Metrics and Profiles (73-LB); Optimizing Basal-Bolus Therapy in T2D: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch vs. an Insulin Pen (987-P); User- and Healthcare Provider-Reported Outcomes for a Wearable Bolus Insulin Delivery Patch (995-P)

    ML Johnson et al.; RM Bergenstal et al.; M Peyrot et al.

    A highly-anticipated trio of posters evaluating J&J’s OneTouch Via/Calibra Finesse (three-day patch insulin bolus delivery device) vs. pen bolus delivery (Novo Nordisk’s FlexPen) in a 62-center, 44-week RCT of type 2s (n=278 with A1c ≥7.5%) ended with very positive results for both groups in terms of A1c outcomes and particularly positive preference results for the Via group. Both groups experienced similarly robust reductions in A1c (~1.6%-1.7% drops!), but patients and providers alike preferred Via over the pen for implementing basal-bolus therapy, suggesting that the “wearable pen” device, which allows for simplified training and discreet insulin delivery, may well drive greater adherence in the real-world setting. Patients were randomized to use either OneTouch Via or the FlexPen when advancing to mealtime insulin, and all used a pattern-based logbook, which combined SMBG values with a simple insulin adjustment algorithm. Initial evaluation lasted for 44 weeks, after which the participants “crossed over” to the opposite therapy for four weeks. During a baseline period and prior to study visits at weeks 4, 12, 24, 36, and 44, participants recorded three days of 7-point SMBG values, and phone calls with subjects were conducted with patients five times during the first eight weeks to assist with self-titration. A CGM sub-study with Dexcom G4 Platinum was performed in 96 of the participants for seven days at baseline and again for seven days between weeks 22 to 24. Top-line, 44-week results showed that A1c decreases were significant in both groups, but not significantly different from each other: the FlexPen group saw their A1c drop an average of 1.7% (baseline: 8.7%) while those on Via saw A1c drop an average of 1.6% (baseline: 8.6%). In both groups, all of the improvement in A1c came in the first 24 weeks, then leveled off at ~7.0% (~83% of the reduction came by week 12), which is certainly a great result coming from an A1c over 8.5%.

    • Both groups also saw significant reductions in fasting plasma glucose at 44 weeks (roughly -20 mg/dl from baseline of ~160-170 mg/dl), as well as significant reductions in 7-point SMBG. In both groups, mean glucose decreased from ~200 mg/dl to ~140 mg/dl and TDD increased from ~50 units to ~130-140 units in both groups (they were under-insulinized, given the high baseline A1c to start). The only reported SMBG metric that significantly differed between the two study arms was coefficient of variation (CV) of mean daily blood glucose between days (an unconventional metric – not the same as within-day CV on AGP reports); both groups started at ~10.5%, and the Via group’s decreased to 9.4%, while the FlexPen group’s increased to 12% (p=0.02). There were no significant differences in hypoglycemia (defined as blood glucose ≤70 mg/dl), though at night, the pen group reported 74 episodes vs. 60 episodes in the Via group (NS, p=0.09).

    • If anything, the study shows a very robust A1c reduction in both groups, but the edge goes by far to OneTouch Via in terms of patient and provider preferences (see below), particularly given that we know that insulin pen use tends to be far better in randomized controlled trial vs. real-world settings. While it was remarkable how well the FlexPen group did, we imagine lots of this stems from the randomized controlled trial setting – far better than we’d see in real-world use. What this also just reinforces to us is that insulin dosing is complicated and that having “real” input by HCPs is also probably really useful. Dosing this drug is really challenging in any setting, however, and we’d also so excited to see Via used with smart, adaptive dosing algorithms.

    • For those in the IDC-run CGM sub-study (n=96), the story was the same at week 24: Both groups saw significant decreases in A1c, time in 70-180 mg/dl, alongside a significant increase in time <70 mg/dl, but none of the between group differences were significant. As a preliminary note, we assume that the G4 Platinum was used in its retrospective, blinded mode, but are not 100% sure. Based on the CGM metrics, both groups benefited tremendously by week 24 from just being randomized in the study, as demonstrated in the AGPs below (flatter, narrower, and more in-range!): In the Via group, time 70-180 mg/dl increased by 6.2 hours/day (48%->74%), time >180 mg/dl decreased by 7.2 hours/day (50%->21%), and time >250 mg/dl shrunk an impressive three hours/day! Variability, measured by standard deviation, decreased from 53 to 46 mg/dl (though when converted to coefficient of variation, it actually increased from 29% to 33%, which is still very stable). OneTouch Via increased hypoglycemia, as time <70 mg/dl and <54 mg/dl increased by a fairly large 50 minutes/day (1%->5%) and 13 minutes/day (0.2%->1.1%), respectively. The outcomes in the pen group were almost identical: Time 70-180 mg/dl increased by 7.9 hours/day (42%->75%), time >180 mg/dl decreased by 8.9 hours/day (57%->20%), and time >250 mg/dl shrunk by 4.5 hours/day! Variability, measured by standard deviation, decreased from 54 to 45 mg/dl (though again, when converted to coefficient of variation, it increased from 27% to 32%). For hypoglycemia, time <70 mg/dl and <54 mg/dl increased by 1 hour/day (1%->5%) and 14 minutes/day (0.2%->1.2%), respectively.


    • Subjective reports from the full study population were almost invariably in favor of the OneTouch Via over the FlexPen, from both patients and providers. At 24 weeks, patch users were significantly more satisfied overall, particularly with the device’s ease of use. Relative to the pen group, they also reported improved discretion, lack of pain, ability to do things “spur of the moment,” social comfort, having insulin on them always, and likelihood of recommending. At 44 weeks however, they didn’t feel that they were more confident, had more peace of mind about managing diabetes, could fit diabetes management into their lives, or were taking positive steps with diabetes management relative to the pen group managing insulin – this is surprising to see, as we would have guessed a stronger response on these. Regarding quality of life, daily functions and diet restrictions were rated more highly in the patch group. In the subject preference survey – since both groups got to use both devices for at least four weeks – every response from both groups was significant in favor the patch (e.g., people felt more satisfied with the patch, preferred it, had to carry fewer supplies around, felt more freedom, and would recommend it over the pen). Both groups also said they wanted to switch from the pen to the patch, but the group that used the patch for 44 weeks followed by four weeks of the pen were significantly more likely to endorse this statement than was the group that used the pen for 44 weeks followed by the patch for four. 

    • One of the most important findings from the study, in our view, is that 91% of providers preferred the OneTouch Via over pens to advance type 2 patients from basal to basal-bolus insulin. In their survey, they endorsed that the device helped them transition patients to basal-bolus faster, facilitated a more gratifying relationship with the patient (though not reflected in the patient survey), will help overcome barriers to initiation, is easy to use and train. They also endorsed that they would prescribe the patch for MDI patients both at and not at goal. This was not a blinded study, so we acknowledge that there may be a bit of “whiz-bang” at play here – “wow, look how cool this device is, if I had diabetes I would love it!” or “this is a new device, I’m supposed to prefer it.” Still, getting providers on board, particularly with the endorsements that it is easy to train and could reduce clinical inertia, would do wonders for driving adoption in the type 2 insulin delivery device field.

    Pipeline: What could follow for the Calibra device?

    • CeQur is currently “looking at” wireless connectivity for both Calibra and PAQ – e.g., dose capture and transmission to a phone. There is no expected launch timing to report. This is obviously much easier for PAQ, which has a reusable electronics component. Management said it already has a connected prototype for PAQ; however, given the delays on the core product, we don’t imagine this anytime soon.

      • At its 2016 Medical Device business review, J&J alluded to two OneTouch Via pipeline products in Q&A: a smart version with connectivity and a larger reservoir version. The latter would obviously expand the type 2 market.

    • We could also imagine other pipeline expansions for Calibra: a one-unit version for type 1, a pediatric indication, longer wear time past three days, and non-insulin drug delivery

    • Said CeQur management: “Calibra is a perfect marriage with CGM.” We look forward to seeing how CGM could help inform smarter Calibra + basal injection dosing  - e.g., could an app offer recommendations tailored for Calibra users? The downside is that Calibra therapy has fewer knobs to turn – a once-daily basal and two-unit bolus increments.

    • A pre-filled insulin version of Calibra is currently not an R&D priority. CeQur believes the current fill process is “very simple” for both Calibra and PAQ, and both products showed “strong success” in human factors testing. Of course, prefilled insulin also adds serious supply chain logistical hassle and FDA hassle (regulated as drug-device combo, like Intarcia). While prefilled would be awesome, we agree this should not be a near-term priority for CeQur.

    Close Concerns’ Questions

    Q: Who will be the earliest adopters of the Calibra device in the US? Will it see more adoption in type 1 or type 2? Will most early users already be on MDI, or will they add bolus insulin through Calibra? Will patients or HCPs drive adoption of Calibra?

    Q: What will payer coverage for Calibra look like at launch? Will the clinical trial results from ADA 2018 help or hurt coverage – i.e., as a new device, Calibra adds cost over MDI with pens, but payers might focus on no significant A1c benefit vs. MDI; that said, there were clear patient/HCP preference advantages, and the A1c reduction with MDI in the trial was far better than real-world… We hope payers think holistically here!

    Q: How will the total cost of care compare between: MDI with pens, Calibra (bolus) + daily basal insulin injections, PAQ (basal-bolus), Valeritas’ V-Go (basal-bolus), and full-featured pump (basal-bolus)?

    Q: What has CeQur learned from Valeritas’ V-Go launch in the US? How will it differentiate the two devices at launch? How large will CeQur’s sales force be? We hope CeQur learns from the successful launch of FreeStyle Libre, which has obvious parallels in our view – no more fingersticks (Libre) vs. no more mealtime injections (Calibra).

    Q: What pipeline advances for Calibra would most increase its potential market – a 1-unit version, connectivity, larger reservoir, insulin dosing algorithms, smart combinations with CGM, etc.?

    Q: Can Calibra help CeQur get to cash-flow positive quickly? With ~18 months of runway, the company will likely need to raise more money in late 2019.

    Q: Will CeQur ultimately be acquired, or will investors move to take the company public? Who is a likely acquirer? Would it make sense to combine V-Go, Calibra, and PAQ under one company? Would a BD, Insulet, Medtronic ultimately acquire CeQur?

     

    --by Adam Brown, Maeve Serino, and Kelly Close