- Global Diabetes Care revenue totaled 515 million CHF (~$515 million), falling 7% YOY as reported against 1% growth in 2Q16 – according to management, price pressures, reimbursement difficulties, and high-frequency testers shifting to CGM accounted for the challenging quarter. The North American business saw sales of 69 million CHF ($69 million) fall a staggering 27% YOY, while sales in the rest of the world totaled 446 million CHF (~$446 million), down a more modest 3% YOY.
- Pooled “Big Three” revenue (Roche, J&J, and Abbott) totaled ~$1.3 billion for the quarter, falling 4% YOY. Unsurprisingly, US weakness drove the pooled declines (-11%), while pooled revenue fell just 2% internationally thanks to continued uptake of Abbott’s FreeStyle Libre overseas (+25% operational growth). Excluding a rough estimate of Libre sales (~$100 million) translates to a much larger pooled decline of up to 12%.
- Management highlighted the acquisition of mySugr in June, both in prepared remarks and the press release – great to see this visibility. The press release put the acquisition into the broader context of Roche’s efforts to build out a “patient-centered digital health service” through a newly-announced Accenture Intelligent Patient Platform.
- The press release confirmed the US launch of the Accu-Chek Guide BGM, adding that the system has also launched in Germany. The Insight CGM (limited launch in EU) was not referenced in remarks or any of the materials, though based on previous estimates from Roche reps, the launch may open up to a broader audience soon.
- The just-finalized R&D agreement with Senseonics and TypeZero to develop an automated insulin delivery system with a 180-day sensor was also not mentioned; however, it does show Roche wants to play in this field.
Roche CEO Dr. Severin Schwan led the company’s 2Q17 financial update this morning (see the slide deck here). It was a very challenging quarter for the Diabetes segment, particularly in the US where sales dropped meaningfully on an easy comparison, but management was enthusiastic about the recent mySugr acquisition. We’re glad to see continued commitment to the diabetes business, and more recently, rethinking the strategy to focus more on digital, CGM, automated insulin delivery, and partnerships. Below, we bring you our top financial, pipeline, and therapy highlights from the call, as well as pooled BGM “Big Three” analysis.
1. Global Diabetes Care revenue totaled 515 million CHF (~$515 million) in 2Q17, falling 7% YOY against a modest comparison (1% growth in 2Q16). The challenged diabetes segment has now experienced declines in 23 of the last 30 quarters. Diagnostics Division CEO Mr. Roland Diggelmann acknowledged that the tribulations can be attributed both to pricing and reimbursement pressures as well as a shift in high frequency testers (particularly type 1) to continuous, sensor-based technologies – it was notable to see this acknowledged for the first time in recent memory. In constant currencies, 1H17 BGM sales fell 3% YOY, while the other product lines of the Diabetes Unit dropped 9% YOY (mainly insulin pumps, though the Accu-Chek Insight CGM underwent a limited EU launch toward the end of 2016).
2. In North America, Diabetes Care revenue totaled 69 million CHF (~$69 million), falling a staggering 27% YOY against an easy 2Q16 comparison (5% sales decline). This is the fourth quarter since 2005 to come in under the 50 million CHF mark – all have come in the past two years – and the sixth in a row under 100 million CHF. As with previous quarters, the slide deck pointed to pricing pressures stateside for the challenging environment. Can the newly launched Accu-Chek Guide BGM, along with the mySugr acquisition, help rebound US sales?
3. Outside of North America, sales of 446 million CHF (~$446 million) fell 3% YOY against a modest YOY comparison (2% growth in 2Q16). Overall, the international business has remained remarkably flat for the past six quarters, with minor quarter-to-quarter fluctuations. For 1H17, total Diabetes Care sales again expanded in Latin America (+3%), but declined in EMEA (-1%), Asia-Pacific (-5%), and Japan (-5%).
Pooled Financial Highlights
4. Pooled global revenue for the “Big Three” BGM companies (Roche, J&J, and Abbott) totaled ~$1.27 billion, falling 4% YOY on an easy pooled comparison in 2Q16 (down 2% to ~$1.33 billion). In the US market, pooled revenue fell 11% to $310 million on a very easy comparison (-16% in 2Q16). Internationally, “Big Three” revenue of $962 million fell 2% against a modest comparison (sales grew 4% in 2Q16). FreeStyle Libre sales outside the US are carrying the pooled revenue in a pretty big way. Subtracting out our estimate of roughly ~$100 million in Libre sales, pooled revenue saw up to a 12% YOY decline.
Device Pipeline Highlights
5. The June acquisition of mySugr was called out both in Diagnostics Division CEO Mr. Roland Diggelmann’s prepared remarks and in the press release – great to see this visibility. Mr. Diggelmann touted mySugr as the leading digital open platform for patient engagement, which now caters to over one million users. We see this move as a victory for both companies and a clear sign that Roche wants to reinvent its diabetes business – see our detailed recap from a few weeks ago.
6. The press release confirmed the US launch of the Accu-Chek Guide BGM, and added that the platform has extended into additional major markets including Germany. The device has some definite incremental improvements, but at this point, is not helping the business recover.
7. Senseonics announced this week that it will develop an automated insulin delivery system with its Eversense XL (180-day implantable CGM), Roche’s Accu-Chek Insight pump, and TypeZero’s inControl AP algorithm. The integrated system will be tested soon at three EU universities – Amsterdam, Padova, and Montpellier – in an arm of the NIH-funded iDCL trial, which will support a CE Mark submission. This shows Roche wants to be in the AID field – big news!
8. There was no mention in prepared remarks, Q&A, or the slide of Roche’s own Accu-Chek Insight CGM, which launched in a controlled fashion in the Netherlands, Norway, Denmark, and Sweden toward the end of 2016. Reps at EASD told us that this phase will last 6-9 months so that Roche can gather feedback before fully rolling it out in more countries in 2017 – according to our calendars, the next phase should begin momentarily if the timeline has been maintained. It’s also possible Roche is focusing more on the Senseonics partnership and less on its own CGM.
9. Just yesterday, Accenture announced that it will collaborate with Roche to improve the management and delivery of diabetes care by developing a data-driven core analytics platform for Roche’s “digital diabetes ecosystem.” The press release is devoid of details on timing for launch, but the agreement will last for five years and shows more Roche commitment to digital health, big data, and broad device integration.
- Executive Highlights
- Financial Highlights
- Pooled Financial Highlights
- Device Pipeline Highlights
- 5. Management Highlights mySugr Acquisition in Prepared Remarks and Press Release – Clear commitment to Digital Health
- 6. Accu-Chek Guide BGM Launches in US + Germany
- 7. Roche Partners with Senseonics/TypeZero to Develop Automated Insulin Delivery; To be Tested in Upcoming Phase of iDCL Trial
- 8. No Update on Accu-Chek Insight CGM
- 9. Accenture to Engineer Data-Driven Platform for Roche’s “Digital Diabetes Ecosystem”
1. Global Diabetes Care Falls 7% YOY; BGM Down 3%, Pumps Down 9% in 1H17
Global Diabetes Care revenue totaled 515 million CHF (~$515 million) in 2Q17, falling 7% YOY against a modest comparison (1% growth in 2Q16). The challenged diabetes segment – which dragged down an otherwise very positive Diagnostics Division performance – has now experienced declines in 23 of the last 30 quarters. In accordance with the pronounced seasonality of the diabetes business – sequential growth in Q2 and Q4, with sequential declines in Q1 and Q3 – worldwide sales grew 15% sequentially from 1Q17 (this quarter’s international revenue is equal to last quarter’s total revenue). It’s been three years since the business topped 600 million CHF, something it used to do routinely prior to a 24% sequential plummet (164 million CHF) in 1Q15.
- Diagnostics Division CEO Mr. Roland Diggelmann acknowledged that the tribulations can be attributed to pricing and reimbursement pressures and a shift in high frequency testers (particularly type 1) from strip-based testing to continuous, sensor-based technologies. Roche seems to be hedging its bets on a number of fronts here by: (i) acquiring mySugr to add more value/insight to diabetes data and focus on population health/coaching/device compatibility; (ii) launching dual next-gen BGMs – Accu-Chek Guide, and Accu-Chek Instant bG for price-sensitive markets; (iii) Commercializing its own Accu-Chek Insight CGM (still limited launch); and (iv) entering an R&D collaboration with Senseonics and TypeZero to develop an automated insulin delivery system with Senseonics’ 180-day sensor, Roche’s Accu-Check Insight pump, and TypeZero’s algorithms. Roche, traditionally focused on BGM and pumps, is clearly putting multiple shots on goal to adapt in a rapidly shifting diabetes care landscape. Can these new forays help the segment return to growth?
Figure 1: Global, North America, International Quarterly Sales (1Q11 – 2Q17)
- In constant currencies, 1H17 BGM sales fell 3% YOY, while the other product lines of the Diabetes Unit dropped 9% YOY (mainly insulin pumps, though the Accu-Chek Insight CGM underwent a limited EU launch toward the end of 2016). That BGM sales fell is a bit of a surprise, given the expansion of the Accu-Chek Guide BGM into major US and German markets, in addition to the Accu-Chek Instant bG rollout – it remains a reflection of negative headwinds from reimbursement, (US) pricing, and competitive pressures both from other BGMs and CGM. We’d also note that these strips are notably cheaper than prior generations, so perhaps the margins are still okay but the revenue won’t show it until volumes rise. It is no surprise that the pump business fell so markedly, as the company discontinued new pump sales in the US as of the beginning of 2017, and strong competitive pressures loom around the world (largely from Medtronic’s MiniMed 640G/670G, Insulet’s OmniPod, and to some extent Tandem). Based on the new move into automated insulin delivery with TypeZero/Senseonics, it’s possible Roche may re-enter the US pump market; for now, the focus seems to be on Europe with this collaboration.
2. North American Revenue Drops Staggering 27% on Easy Comparison (-5% in 2Q16)
In North America, Diabetes Care revenue totaled 69 million CHF (~$69 million), falling 27% YOY against an easy 2Q16 comparison (5% sales decline). Sequentially, sales grew 40% against the backdrop of a marked 33% sequential decline in 1Q17. This is the fourth quarter since 2005 to come in under the 50 million CHF mark – all have come in the past two years – and the sixth in a row under 100 million CHF. As with previous quarters, the slide deck pointed to pricing and reimbursement pressures stateside for the challenging environment. Last quarter, Diagnostics Division CEO Mr. Diggelmann called 1% quarterly growth in North America “solid” and “encouraging” despite a challenging environment – obviously the business’ seasonality and market challenges made this hard to sustain in 2Q17. Overall for the first half of 2017, Diabetes Care fell by 18% YOY. Roche stopped selling new pumps in the US as of January 1, which could have partially contributed to the drop in revenue.
- One of our first observations upon entering the massive ADA exhibit hall last month was: “Where’s Roche?” The company in fact did not have a booth at this year’s conference to show off its new Accu-Chek Guide BGM or soft-launched Insight CGM system in Europe – a notable departure from the elaborate booths complete with arches, tunnels, educational games, and immersive experiences that the company usually builds. This was not highly surprising from one perspective – it’s a tough time for Roche’s US BGM business and it has discontinued new US pump sales – but the juxtaposition with other players was noted. Glooko, Companion Medical, One Drop, and many other smaller device companies were indeed present in the massive ADA hall. This was perhaps: (i) a sign that Roche is being more choosey with its marketing resources (do exhibit hall booths have good ROI relative to other investments?); (ii) reflective of Roche’s smaller geographic sales base in the US; (iii) because Roche had fewer new products to showcase at this ADA; and/or (iv) something else.
3. Revenue Outside of North America Down 3% YOY
Outside of North America, sales of 446 million CHF (~$446 million) fell 3% YOY against a modest YOY comparison (2% growth in 2Q16). The alternating up-down sequential pattern that has come to characterize the international business (see Figure 1 above) continued this past quarter (rising 12% from 1Q17 following a 13% sequential decline in the previous quarter). For the past six quarters, despite quarter-to-quarter fluctuations, the international business has remained remarkably flat. This is most of the company’s business anyways and a sign that the core business is holding somewhat steady, despite the big challenges in the field. For 1H17 at a geographic level, total Diabetes Care sales again expanded in Latin America (+3%), but declined in EMEA (-1%), Asia-Pacific (-5%), and Japan (-5%).
Pooled Financial Highlights
4. Pooled “Big Three” BGM Revenue for the Quarter Falls 4% to $1.3B
Pooled global revenue for the “Big Three” BGM companies (Roche, J&J, and Abbott) totaled ~$1.27 billion, falling 4% YOY on an easy pooled comparison in 2Q16 (down 2% to ~$1.33 billion). Abbott continues to be the lone standout of the group in terms of growth (albeit from a lower sales base), riding a wave of five consecutive growth quarters, including two consecutive 20%+ performances. Meanwhile, J&J has seen 11 straight quarters with YOY declines and Roche’s YOY growth hasn’t topped +3% since 1Q10. This quarter, Abbott’s sales of $336 million rose a strong 21% operationally year-over-year (YOY). Of course, its international business (+25%) drove top-line growth, clearly on the strength of FreeStyle Libre, making the comparison to J&J and Roche BGM tenuous (Roche also has CGM and insulin delivery, and J&J also has insulin delivery, but neither is meaningful at this point). Abbott is clearly investing heavily in FreeStyle Libre, Roche is moving into CGM with Senseonics and digital with mySugr, and J&J is still evaluating various strategic options for its struggling LifeScan/Animas business. The question, of course, is how the BGM companies will innovate in products and business models to deliver much more value and better outcomes at lower costs. Notably, since Abbott partnered with Bigfoot and Roche with Senseonics/TypeZero, all three companies are technically have automated insulin delivery plans (though the Animas program is on hold and we’re not sure if it will even come to market at this point).
Figure 2: Worldwide Pooled Roche, Abbott, and J&J Quarterly Sales (1Q12 – 2Q17)
- In the US market, pooled revenue fell 11% to $310 million on a very easy comparison (-16% in 2Q16). J&J LifeScan and Roche both pointed to pricing pressures as a headwind, though we imagine Abbott was also negatively impacted – we can’t remember the last time we heard Abbott CEO discuss the company’s legacy BGM business in-depth on an earnings call (perhaps not since 2Q15, based on our writing!). Roche had the most difficult 2Q17 in the US (North America), as sales fell 27% YOY, while J&J sales fell 10%, and Abbott sales actually grew 8%. Roche sales do encompass all of North America, but we have included the figure in our US calculation because individual country revenues are not reported (and presumably the US dominates this geography for Roche). The ~$300 million US decline since 1Q12 (see below) shows the true devastation of pricing, reimbursement, and competitive pressures on the BGM arena stateside – the once-giant business has been literally cut in half over the past five years.
Figure 3: US Pooled Roche, Abbott, and J&J Quarterly Sales (1Q12 – 2Q17)
- Internationally, “Big Three” revenue of $962 million fell 2% against a modest comparison (sales grew 4% in 2Q16). Sequentially, pooled revenue grew 12%. J&J’s international revenue fell 10% YOY, Roche’s fell 3%, and Abbott’s shot up 25% to a record-high. There are now over 300,000 FreeStyle Libre users in the world – if roughly-estimated Libre sales of ~$100 million (~120 euros per month; 100% utilization) are excluded from the pooled international calculation, then pooled international revenue actually fell 12% YOY. Similarly, pooling just J&J and Roche international sales suggests BGM sales declined 8% YOY outside of the US.
Device Pipeline Highlights
The acquisition of mySugr in June was called out both in Diagnostics Division CEO Mr. Roland Diggelmann’s prepared remarks and in the press release – great to see this visibility and commitment. Mr. Diggelmann detailed the numerous headwinds facing the BGM business, which are par for the course during the transformation in diabetes toward a more “comprehensive, holistic” approach where “more patients are taking ownership of their diabetes management.” He touted mySugr as the leading digital open platform for patient engagement, which now caters to over one million users. As we noted a few weeks ago, mySugr will still operate as an independent/autonomous company under Roche, remaining an open platform for insurers and device/pharma companies. According to one source we spoke to, mySugr was valued between ~$75 million-$100 million. If true, that lends massive confidence that Roche is making/will continue to make a significant investment in digital diabetes care.
- Indeed, the quarter’s press release put the mySugr acquisition into the context of Roche’s broader plans: “…Roche is further building its platform for digital diabetes management. This is a new patient-centered digital health service in diabetes care, which helps healthcare providers utilizing existing Accu-Chek tools to make better and faster therapy decisions while improving communication with their patients.” This clinician-facing slant was not a major focus when the acquisition was announced, but we’re intrigued by the move toward decision support and what role mySugr will play (mySugr already offers coaching and population management programs, which we imagine could be leveraged here).
- Roche has been an investor/integrated BGM partner to mySugr since at least 2015, though this news shows the BGM giant’s clear desire to reinvent itself and put digital technology/software at the center of its strategy. We love the company’s desire to partner with other device companies, connect patients and caregivers, drive time-in-range outcomes and relieve burden, put patients at the center, and help mySugr to “make diabetes suck less.” See our full report on the acquisition for details.
6. Accu-Chek Guide BGM Launches in US + Germany
The press release confirmed the US launch of the Accu-Chek Guide BGM, and added that the platform has extended into additional major markets including Germany. In 3Q16, the next-gen system launched in Denmark, Switzerland, and Australia, and we were told at ATTD 2017 that Germany, Italy, and the US were to follow in 1Q17. Diagnostics Division CEO Mr. Diggelmann expressed hope a couple of quarters ago that the Guide will “protect and safeguard this franchise” – we’ll be looking for an indication as to whether he was right in the back half of this year, after Guide has had time to take hold in the US and Germany. We love how the meter was refreshingly launched in the US with a major focus on affordability AND highly accurate strips. Patients can get the meter for free and sign up for the SimplePay savings card at Accu-Chek’s website. With the card, a vial of 50 strips is $19.99, and each incremental 50 strips thereafter will add just $10. This means 100 strips for $29.99, 150 strips for $39.99, etc. That’s between $0.22-$0.40 per strip without insurance, depending on the quantity purchased – nice! Patients can also get the meter through the mySugr Logbook app integration – those interested can download a voucher in the app and get a free upgrade to mySugr Pro.
- Roche also announced in February that it has signed an “exclusive” agreement with Medtronic to develop a dedicated Bluetooth-enabled blood glucose meter that will communicate with Medtronic's future Bluetooth-enabled insulin pumps. The meter will be based on Roche's new Accu-Chek Guide platform and sold under the name “Accu-Chek Guide Link.” The deal is exclusive and covers all markets where future Bluetooth-enabled Medtronic pumps will be sold – a major win for Roche BGM business moving forward! Medtronic Global Diabetes CMO Dr. Fran Kaufman confirmed at Keystone earlier this month that a 670G pump with connectivity is coming (no specific timing shared).
- The slide deck noted again that the Accu-Chek bG Instant System launched in the EU. We’re not sure what the US plans are for the Instant, but Roche told us the initial launch countries are Greece, Romania, and South Africa. Roche is positioning the meter as an “effortless, accurate and affordable bG system for price-sensitive markets.” We got to see it in person at ATTD 2017, where a rep told us the device has a streamlined feature set including a target range indicator, Bluetooth connectivity, and just a single button, and that it may be better for patients who don’t need all of the whistles and bells offered by the Guide, but just a quick indication of blood sugar. We appreciate that the company is making more options available, especially with price point in mind.
- See our mini test drive of the next-gen Guide system – we especially liked the strips’ very wide blood application area.
Senseonics announced this week that it will develop a long-term automated insulin delivery system with its “Eversense XL” (180-day implantable CGM), Roche’s Accu-Chek Insight pump, and TypeZero’s inControl AP algorithm. The integrated system will be tested soon at three EU universities – Amsterdam, Padova, and Montpellier – in an arm of the continually-expanding-and-very-hard-to-follow NIH-funded iDCL trial. Notably, this is expected to support a CE Mark submission, though this R&D agreement does not contain commercial terms. Start date, completion date, and commercialization timing are not clear at this point, but if the trial begins soon (a big “IF”), a launch seems possible in the 2019-2020 timeline (our speculation). This news establishes that Roche is indeed IN on automated insulin delivery, giving the Diabetes business a reinvigorated pipeline (along with the recent mySugr acquisition). We wonder if Roche will be the company to commercialize the system, and if so, when that might happen – by our estimates, it could be anywhere from third to fifth to market in the EU, likely behind MiniMed 670G and possibly behind Cellnovo, Diabeloop, and/or Insulet. We also wonder what effect this would have on the business, how hard it will be to have three partners on a system, if the 180-day Senseonics sensor will be a compelling value-add, whether Roche would work its own Accu-Chek Insight CGM into additional closed loop systems, and what the company’s plans are for the US. (The Accu-Chek Insight pump is currently not registered in the US, and the iDCL study is not expected to support a submission; however, a goal is to generate data to support submissions for future pump systems.)
- Roche had a broad distribution agreement with and recently invested $30 million in Senseonics prior to this announcement. Per the distribution agreement, Roche will distribute the implantable Eversense CGM in all of Europe, the Middle East, and Africa, excluding Scandinavia (where Rubin Medical is the distribution partner), Finland, and Israel. According to Senseonics management, there are now “plenty” of patients using Eversense in Europe; obviously revenue is not meaningful at this point and we’ll wait until the quarterly report to have a better sense of the real scale here. Per the 1Q17 update, commercial launches of Eversense have occurred in Germany and Sweden (with distributor Rubin Medical), and market presence in eight European countries is expected by mid-2017 (Sweden, Germany, Italy and Netherlands in limited fashion, plus four more), We’ll be listening for further indications of uptake on the 2Q17 call (date and time TBD) – as a reminder, the company predicted a modest $6-$7 million in FY17 revenue in February.
8. No Update on Accu-Chek Insight CGM
There was no mention in prepared remarks, Q&A, or the slide of Roche’s own Accu-Chek Insight CGM, which launched in a controlled fashion in the Netherlands, Norway, Denmark, and Sweden toward the end of 2016. We’d note that having Senseonics as a partner, along with its own CGM, does create an interesting conundrum on which to prioritize (not unlike that of Ypsomed and Insulet, who just announced their agreement will end). Reps at EASD told us that the Insight limited launch phase will last 6-9 months so that Roche can gather feedback before fully rolling it out in more countries in 2017 – according to our calendars, the next phase should begin momentarily if the timeline has been maintained. Dr. Irl Hirsch alluded to the device at ENDO 2017, suggesting that Roche will start pivotal trials (presumably for the US) this summer – we haven’t heard anything further on this, and we’d also note that Senseonics’ Eversense is under FDA review. At ATTD, we also learned that Roche will perform experiments to examine the sensor’s stability over 14-15 days (it is currently intended for seven-day wear with two calibrations per day). Roche has now indicated it is moving into automated insulin delivery R&D, but it’s unclear if it will move Insight forward in parallel with Senseonics’ sensor.
- In the CE Mark approval trial (n=36; details shared at DTM), the sensor performed with encouraging reported accuracy (overall MARD: 10.6%) and time lag (mean lag post-processing: 5.5 minutes). See our EASD coverage for a deeper dive into the CGM – how does it stack up to other options? – along with pictures.
9. Accenture to Engineer Data-Driven Platform for Roche’s “Digital Diabetes Ecosystem”
Just yesterday, Accenture announced that it will collaborate with Roche to improve the management and delivery of diabetes care by developing a data-driven core analytics platform for Roche’s “digital diabetes ecosystem.” This new ecosystem will be built on the Accenture Intelligent Patient Platform, allowing Roche to securely gather and analyze data, generate insights, personalize patient care, and integrate all existing and future products and services. The agreement lasts five years, during which the platform will be available to connect patients, caregivers, and providers with a “suite of digital health services” across North America, Europe, and Asia. The press release is devoid of details on timing for launch and how exactly patients and providers will interact with the platform. Still, we appreciate the focus on the patient, making the integration of various products simpler, and generating better insight at a population level – in fact, we might interpret this as a competitor to Medtronic CareLink or Dexcom’s Clarity, but with potential for broader device compatibility. Of course, this also fits nicely with the mySugr acquisition. Roche appears committed to pivoting away from traditional BGM and insulin delivery business models to something more data/digitally-driven and better suited for remote, value-based care. We like seeing more shots on goal, though we’ll have to see if this actually comes to market, how quickly, and what it will look like.
-- by Brian Levine, Payal Marathe, Adam Brown, and Kelly Close