Memorandum

Medtronic 1Q20 (F4Q20) – Diabetes sales of $570 million decline 9% YOY; MiniMed 780G approval in Europe “this quarter,” MiniMed 770G approval in US in “summer” – May 21, 2020

Executive Highlights

  • For 1Q20 (F4Q20), Medtronic reported worldwide Diabetes revenue of $570 million, declining 9% YOY as reported (-7% operationally, -7% sequentially). The 9% revenue decline is the largest YOY decline since at least 2004; while, given the 25% YOY decline in Medtronic’s overall revenue, Diabetes fared relatively well, the comparison to other pump manufacturers in aggregate is more negative (the rest of Medtronic happens to be other hospital-based medical technology, as well, so it is not surprising that the consumer element of Medtronic’s business did relatively better although this does not help them on a competitive front – though it is a buffer for the rest of the business).

    • The biggest impact from the pandemic on Medtronic Diabetes was on reductions in new insulin pump starts, while sales of supplies (i.e., CGMs, infusion sets) actually increased (though likely as “stockpiling” rather than something that is a sustainable increase).

  • Notably, international Diabetes revenue topped that of the US, for the first time ever (our model dates back to 2004). Medtronic’s “non-US developed markets” did moderately well, with 5% revenue growth as reported (+9% operationally), on an easy comparison while US revenue declined 17% YOY to $274 million. This compared to a 10% US decline in 1Q19, also an easy comparison – meaning, had Medtronic’s US revenues in 1Q19 grown, the comparison would’ve been even worse.

    • We expect international sales to be strong for Medtronic assuming that the MiniMed 780G will be approved in Europe and other CE markets before Tandem’s Control-IQ and Insulet’s Omnipod Horizon. Tandem expected to roll-out Control-IQ in Europe in the second half of 2020, but we believe this has been pushed back to due COVID-19. Insulet’s Omnipod Horizon won’t be on the US market until 2021 and broader European rollout for Omnipod Dash has also been pushed back to 2021. See below for the pipeline update.

  • Medtronic added ~12,000 more “trained, active users” for MiniMed 670G in 1Q20, bringing the total to ~249,000. The ~12,000 sequential adds comes in slightly under ~13,000 sequential adds in 4Q19; new starts on 670G have slowed down, as anticipation for MiniMed 780G continues to build. As a reminder, unlike Tandem and Insulet, there is no way to upgrade Medtronic’s current pump (the 670G pump) to the “next gen” (780G) algorithm at no charge and little hassle. Still, Medtronic Diabetes certainly continued to grow during 1Q19 – indeed, a quarter of a million users total is an impressive number for the first-to-market hybrid closed loop system.

  • MiniMed 780G is expected to receive approval in Europe “this quarter,” meaning Medtronic first calendar year quarter of 2021, or by July 31, 2020 – Although a timeline for launch was not shared, presumably this would be as soon as possible after approval that is reasonable in the pandemic.

  • On the US front, Medtronic announced plans to launch a “MiniMed 770G” device, which is expected to get FDA approval “this summer” – the real news of the quarter was that the “real” 780G (the pump with the new algorithm) is now set to emerge in the US by April 2021. We believe the new “MiniMed 770G” is the pump hardware for the MiniMed 780G system that was submitted for FDA review back in 3Q19. It seems the MiniMed 770G will ship with the same algorithm as 670G, as CEO Geoff Martha described it as a “hybrid closed-loop system.” Although the “MiniMed 770G” was not technically characterized as a delay, from our view, the algorithm is the key differentiator between the 670G and the 780G rather than the hardware. On a positive note for children, MiniMed 770G will be available for patients ages 2-6, making AID available for 2-6 year-old patients in the US for the first time.

  • As would be expected, patients who purchase the MiniMed 770G will be able to upgrade to 780G algorithm for free when that algorithm is launched “later in the fiscal year” (i.e., FY21 ends April 2021). As expected, adult pivotal trial data for MiniMed 780G will read out at ADA 2020. We look forward to dQ&A data that will show patient views on whether they will opt to wait approximately one year for the “better” Medtronic algorithm or whether they will opt for Tandem Control IQ now or the Insulet Horizon in early (possibly) 2021.

  • Regulatory submission for Medtronic’s Zeus iCGM is expected by “end of summer.” The pivotal trial has either finished or is expected to finish by the end of the month. Zeus retains the same form factor, reusable transmitter, and 7-day wear as Guardian Sensor 3, but will be day 1 calibration only (vs. 2 fingersticks/day) and presumably meet iCGM criteria (this has yet to be confirmed). Investigational device approval for the Synergy CGM is expected “within the next few weeks,” though its unclear when that trial will begin. There were also no updates on non-adjunctive labeling for Guardian Sensor 3.

  • During Q&A, there was one key diabetes question - one analyst asked whether Medtronic was still expecting 780G to achieve its ambitious >80% Time in Range target. Diabetes President Sean Salmon declined to share too much, but did share that there would be “a lot to unpack”:

  • Medtronic has been quite involved in the response to COVID-19 and we’ve highlighted some of the company’s efforts below. These include expanding its financial assistance program, ramping ventilator production, and making over financial and product donations to groups around the country.

Medtronic reported its 1Q20 (F4Q20) financial results this morning on a call led by CEO Geoff Martha, CFO Karen Parkhill, and Executive Chairman and outgoing CEO Omar Ishrak. It was Mr. Ishrak’s 36th, and final, appearance on Medtronic’s earnings calls and several analysts offered their congratulations to Mr. Ishrak during Q&A. Mr. Ishrak took over as Medtronic’s CEO in 2011, doubling the company’s annual revenue overall and guiding the company through the largest ever medical technology acquisition ($43 billion acquisition of Covidien in 2014). More pertinent for diabetes, Medtronic Diabetes revenue was $1.5 billion exiting 2011, and it’s up 60% over that period, having reached $2.5 billion in the latest year (lower than the $3.0 billion that would have been the “double” similar to what some of the rest of the company saw). New CEO Geoff Martha was poised in his first earnings call as CEO, especially given the challenging circumstances around the pandemic. New Medtronic Diabetes head Sean Salmon was also on the call though only one question was directed toward diabetes.

Diabetes is on slide #10 here and read on below!

Financial Highlights

1. Worldwide revenue of $570 million, declines 9% YOY; US sales drop 17% YOY ($274 million), while OUS stays flat ($296 million)

For 1Q20 (F4Q20), Medtronic reported worldwide Diabetes revenue of $570 million, declining 9% YOY as reported (-7% operationally, -7% sequentially). Pre-COVID-19 guidance for Diabetes expected revenue to stay “flat” or “down [by] low single-digits” and we would look for further, worse-than-expected declines. The 9% revenue decline is the largest YOY decline since at least 2004; while compared to the 25% YOY decline in Medtronic’s overall revenue, Diabetes fared relatively well, we look for further competitive declines that are worse than forecast. Medtronic’s Cardiovascular, Minimally Invasive Therapies, and Restorative Therapies groups saw YOY revenue declines of 34%, 14%, and 33% as reported, due to impacts from COVID-19 and the hospital-intensive nature of these businesses. As the company shared a few weeks ago, the biggest impact from the pandemic on Medtronic Diabetes would be on reductions in new insulin pump starts, which is a big deal, while sales of supplies (i.e., CGMs, infusion sets) would be less affected – that said, given the new news of the later-than-expected US appearance of the 780G, we would expect more of those waiting for the 780G may migrate to Tandem or Insulet (once the new Insulet AID emerges) or more may move to the Loop option using Insulet. Indeed, Medtronic’s 1Q20 materials note increases in sales of supplies due to users stocking up, particularly in international markets; this increase was not quantified but we don’t see it as sustainable and may well result in weaker consumables as early as the next reported quarter. Sequentially, sales fell 7% from 4Q19 – this followed a slightly challenging comparison as there had been a sequential increase of 2% a quarter earlier.

  • Notably, for the first time ever, international Diabetes revenue topped that of the US – international revenue as a percent of total revenue has been increasing for quite some time; US revenue has been in slow, but steady, decline, since early 2018, driven by increased competition. For example, early 2018 saw Tandem’s Basal IQ filed with the FDA as well as Dexcom’s enthusiastical endorsement of Tandem’s hybrid closed loop. What a difference (nearly) two decades make - our model dates back to 2003, when Medtronic’s international revenue represented just 20% of total revenue. Back then, there was not nearly as much interest in or international coverage of continuous insulin delivery and the impact on outcomes was nothing like what is seen today with automated insulin delivery.

    • OUS sales in 1Q20 totaled $296 million, flat with 1Q19, when international revenue represented 47% of total sales, in contrast to just under 52% of sales for 1Q20, which reflects mainly weaker US sales. Medtronic’s “non-US developed markets” were a particular bright spot, with 5% revenue growth as reported (+9% operationally) – other international sales obviously declined, that led to flat international performance, but we’re not sure which ones. Continued adoption of MiniMed 670G and CGM kept international sales growing in many international locales, as did users stocking up on supplies  - we’d expect the latter may result in relative international weakness in quarters ahead. As seen in our model, international revenue exceeding the US revenue was fairly inevitable given the increasingly competitive US market, with Tandem Diabetes Control IQ in particular – international revenue even a quarter ago was already at 49% of the total in calendar 4Q19, before the official Tandem launch and we’d expect lower US revenue to continue without a major marketing push by Medtronic, which we think is unlikely. We do notice that many HCPs love the Carelink software – that won’t be enough to change minds of patients if we had to guess although we’ve heard highly positive commentary on the 780G algorithm – though without a new sensor, a weak link will remain.    

  • US revenue declined 17% YOY to $274 million in 1Q20 on an easy comparison to an 11% decline in 1Q19. Sequentially, US sales fell 12% from 4Q19. The 17% YOY revenue decline is the largest decline ever (again, our model dates to 2003) and the $274 million in US revenue is the lowest since 3Q17. Though sales certainly took a hit from COVID-19, this is the sixth straight quarter of YOY decline for Medtronic’s US Diabetes sales and we suspect 2Q20 will show a bigger decline from COVID-19. While the 1Q20 US decline reflected likely a month and a half of COVID fallout (WHO termed COVID-19 a pandemic on March 11, 2020), the “double whammy” reflected likely nearly a full quarter of competitive fallout – though that within a growing market.

  • To add more short-term challenges, in the US, Medtronic continues to face very strong competition on both the CGM and insulin pump fronts; Abbott’s FreeStyle Libre saw record 1Q20 revenue, while Dexcom, Tandem, and Insulet all continue to report very strong growth on ever-increasing bases. As noted, however, both markets are growing, and the 780G has a stronger algorithm than the 670G, which is very important to many patients - we’ll take a closer look at these dynamics in our 1Q20 roundup (coming soon).

    • We also note that Medtronic has some very strong payer relationships and payer data, such as United – we also believe many HCPs believe they can give more actionable advice with Medtronic’s CareLink software.

2. MiniMed 670G Adds ~12,000 Users Sequentially, Rising to “~249,000”

Medtronic added ~12,000 more “trained, active users” in 1Q20, bringing the total to ~249,000. Most of these additions likely came from outside the US, given the differences in sales trajectories. MiniMed 670G also faces less competition in international markets, though Tandem and Insulet continue to expand into new geographies. The ~12,000 sequential adds comes in slightly under ~13,000 sequential adds in 4Q19; this is not a surprise, as anticipation for MiniMed 780G continues to build (and no way to upgrade 670G pumps to the 780G algorithm). Still, a quarter of a million users is an impressive number for the first-to-market hybrid closed loop system.

3. Guidance suspended, Institutional Investor and Analyst Day postponed; “encouraging signs of earlier-than-anticipated recovery”; good time for M&A?

As many other companies have done, Medtronic suspended its guidance for both the second quarter and full year due to COVID-19. The company also announced that its Institutional Investor and Analyst Day, originally scheduled for June 2, will be postponed. This s always a highlight from our view and a great source of information – we were very sorry to hear this. Instead, during prepared remarks, CFO Karen Parkhill gave some commentary around dynamics Medtronic is seeing around COVID-19. Ms. Parkhill said the company was already seeing slower declines in weekly revenue “over the first few weeks of May” with “encouraging signs of earlier-than-anticipated recovery in several places around the world.” In late March, Medtronic saw “approximately 60%” YOY declines in US weekly revenue; today, Ms. Parkhill shared that those declines were “around 30%” in May. This was not that relevant to diabetes in our view as it’s difficult to parse out the impact on Medtronic’s only consumer business from that broad aggregate data – though we know the hospital business is improving. As we saw in in 1Q20, Diabetes is expected to see a decline in 2Q20 (F1Q21), and while it will be a smaller decline compared to the overall company, that is not illuminating too much.

  • With one analyst estimating asset prices “down 20% across-the-board,” CEO Geoff Martha agreed it was a “good time to do M&A [mergers & acquisitions].” Mr. Martha clarified that that doesn’t mean Medtronic will lower its standards for potential acquisitions, but that the company could “play offense.” As he’s expressed before, Mr. Martha noted a preference for tuck-in acquisitions that can affect long-term growth rate. We can think of lots of smaller companies that would improve Medtronic’s business, though we’ll refrain from speciifcs at the moment – but, we hope Medtronic’s new diabetes leader, the highly regarded Sean Salmon, is thinking this way as there is so much synergy to consider. Today, Mr. Martha also specified a preference for deals in the “medium billion-dollar range, because it has a bigger impact on our growth rate.” Medtronic generated $6 billion in free cash flow in FY20 (April 2019 – April 2020) and ended the quarter with nearly $11 billion in cash.

Pipeline Highlights

1. European approval for MiniMed 780G expected “this quarter”; MiniMed 780G Pump (“MiniMed 770G”) approval expected in “summer” in US, with free 780G algorithm upgrade before April 2021

During prepared remarks, Mr. Martha gave several updates around MiniMed 780G, starting with expected approval for MiniMed 780G in Europe “this quarter.” We first learned that 780G had been filed for CE-Marking in February during the company’s 4Q19 update. It was not officially mentioned, but presumably European launch of 780G would come soon after approval. Getting MiniMed 780G in Europe and other CE markets before Tandem’s Control-IQ and Insulet’s Omnipod Horizon would certainly help maintain Medtronic’s strong market position outside the US. Tandem expected to roll-out Control-IQ in Europe in the second half of 2020, but we believe this has been pushed back to due COVID-19. Insulet’s Omnipod Horizon won’t be on the US market until 2021 and broader European rollout for Omnipod Dash has also been pushed back to 2021.

  • On the US front, Medtronic announced plans to launch a “MiniMed 770G” device, which is expected to get FDA approval “this summer.” We believe this is the pump hardware for the MiniMed 780G system that was submitted for FDA review back in 3Q19. It seems the MiniMed 770G will ship with the same algorithm as 670G, as Mr. Martha described it as a “hybrid closed-loop system.” This was brilliant marketing in our view since it the 770G name makes it sound like “nearly” the 780G though if it is missing the algorithm, this is not all that close from our view.

  • On a positive note, however, the MiniMed 770G will be available for patients ages 2-6, making AID available for 2-6 year old patients in the US for the first time. MiniMed 670G is currently indicated for ages 6+, while the 6-14 years indication for Tandem’s Control-IQ was just submitted to the FDA. Patients who purchase the MiniMed 770G will be able to upgrade to 780G algorithm for free when that algorithm is launched “later in the fiscal year” (i.e., FY21 ends April 2021). MiniMed 770G keeps largely the same form factor and design as 670G, while adding Bluetooth connectivity, enabling remote software updates and mobile apps for secondary display and wireless data uploads. We imagine this feature will be particularly useful for parents and caretakers. It’s unclear if MiniMed 770G was submitted as an ACE (interoperable) pump or through the traditional pump pathway.

    • Also on a positive note, Medtronic’s 1Q20 slides (Diabetes on slide #10) notes that the “Next Tech Pathway” continues to “gain acceptance.” The program allows “customers who are out of warranty or new to pump therapy” to purchase a 670G now and upgrade to the 780G at no cost when it becomes available. For users of the programs, Medtronic is “deferring a portion” of each 670G sale until after patients exchange the 670G for the 780G. Medtronic's Device Upgrade page still advertises a $399 fee for upgrading an in-warranty pump to the “latest technology”; hopefully, that will remain in place for in-warranty users looking to move to 708G. Both the Next Tech Pathway and Medtronic’s MiniMed 770G should help to mitigate the effect of out-of-warranty or new-to-pump patients waiting to buy a new pump until MiniMed 780G arrives. The moves are also an attempt to reduce defections of Medtronic pump users towards Tandem’s Control-IQ system, which was launched in January. Enabling remote software updates in 780G will help limit this problem in the future, as users will be able to get Medtronic’s latest software without having to switch their pump hardware.

  • As planned, the adult pivotal trial for MiniMed 780G will read out at ADA in June. Like the 670G pivotal, the 780G pivotal is single-arm, i.e., it will compare the same patients before and after using 780G; in contrast, Tandem’s Control-IQ pivotal (read out at ADA 2019), was randomized, comparing the closed loop group with a separate sensor-augmented pump group. Medtronic will also highlight data from a randomized trial in New Zealand at ADA; this was the trial used for CE-Mark submission. We believe the pediatric pivotal (ClinicalTrials.gov page) for 780G has been slightly delayed due to COVID-19, with primary completion now expected in August 2020.

    • During Q&A, one analyst asked whether Medtronic was still expecting 780G to achieve its ambitious >80% Time in Range target. Diabetes President Sean Salmon declined to share too much, but did share that there would be “a lot to unpack”: “We really evaluated a number of different things in that study. Most importantly, we looked at targeting the glucose settings with patients with two different levels [of glucose targets]. One is the usual level that we have with 670G today [120 mg/dl], and the other one is a more aggressive lower target [presumably, 100 mg/dl], and we're evaluating the safety of that. So, as you look at those results, you'll see that there's really a lot to unpack there. But, we're very confident in the product and look forward to sharing the results next month.”

  • As a reminder, MiniMed 780G will add: automatic correction boluses (in addition to basal modulation), an ambitious >80% Time in Range goal, an adjustable target down to 100 mg/dl, fewer alarms, and simpler operation. Medtronic is catching up to Tandem by adding remote software updating and a mobile app for secondary display and wireless data uploads. As a reminder, the Guardian Sensor 3 has already been submitted to FDA for a non-adjunctive indication (see below). The Guardian Sensor 3 CGM is the one piece that is significantly behind competitors, as it will require two fingersticks per day and only offer seven-day wear.

Slide taken from Medtronic’s ADA 2019 Analyst Briefing.

2. CGM updates: Zeus iCGM FDA and CE submissions by “end of summer”; Synergy IDE submission “within the next few weeks”; no updates on non-adjunctive Guardian Sensor 3

An update on Medtronic’s CGM pipeline was briefly given by Mr. Martha during prepared remarks. He did note that clinical trial enrollments and start-ups have been delayed due to COVID-19; in terms of CGM, we believe this only applies to the “Synergy” CGM, as the “Zeus” CGM pivotal trial was well underway before COVID-19 and has either finished or will have finished by the end of the month.

  • Submissions to “regulatory agencies” (presumably, FDA and CE) for Zeus are expected by “end of summer.” This is in line with previous expectations for regulatory filing in the April to October 2020 window. Zeus retains the same form factor, reusable transmitter, and 7-day wear as Guardian Sensor 3, but will be day 1 calibration only (vs. 2 fingersticks/day) and meet iCGM criteria. 

  • Medtronic’s Synergy CGM has “completed verification” and IDE submission is expected “within the next few weeks.” Getting IDE approval will allow Medtronic to run a pivotal study for Synergy, though, as noted above, the actual trial timing could be delayed due to COVID-19. The device was last expected to launch by ADA 2021. Synergy features a fully disposable form factor, seven-day wear, day 1 calibration, and iCGM designation.

  • Since regulatory filing in July 2019, we still have not heard any updates on non-adjunctive indication for Guardian Sensor 3. Non-adjunctive labeling would not only remove the need for a confirmatory fingerstick before delivering a bolus with the 670G but also allow it to apply for Medicare reimbursement. To our knowledge, it would also be necessary for the 780G which will deliver automatic correction boluses.

3. Not Mentioned: Extended Wear Infusion Set, Personalized Closed Loop, Tidepool Loop, Sugar.IQ App Improvements, Novo Nordisk Smart Pen Integrations

Outside of CGMs and MiniMed 780G, there were no updates on the rest of Medtronic’s Diabetes pipeline.

  • At ATTD 2020, Medtronic announced CE-Marking for its 7-day extended-wear infusion set, though we didn’t hear any potential launch timings. In the US, the extended-wear infusion set has IDE approval and according to this ClinicalTrials.gov page, the trial is expected to complete in October 2020.

  • Personalized Closed Loop – FDA submission in November 2020-April 2021 and launch by ADA 2021. This will have a lot of investment in the algorithm, leveraging the Nutrino and Klue acquisitions. Both of these acquisitions should help Medtronic strengthen its efforts to advance the Personalized Closed Loop which is supposed to include meal prediction (“no more carb counting”).

  • Since the announcement, we have not heard any updates on Medtronic’s partnership with Tidepool Loop. Though there is certainly at least a remote possibility the 780G hardware (already submitted to FDA) was filed as an interoperable ACE pump, this hasn’t been confirmed. The initial interoperability announcement caught some off guard, and while we certainly applaud Medtronic for recognizing the value of and supporting a growing interoperable ecosystem, we wonder the degree to which the announcement was just marketing (the company knows this is a popular topic) and to what degree it’s actual dictating product strategy.

  • Medtronic had previously mentioned that it planned on launching “smart-guide” system for Sugar.IQ by April 2020. The system would add basic” CGM-based insulin dosing guidance, a predictive trace, and some advising. By April 2021, Medtronic plans on adding a “virtual optimizer” to bring more personalized dosing with the Synergy disposable sensor. Given the lack of updates on this product, we are not certain if these timelines are still current.

  • Medtronic’s CGM and Novo Nordisk’s smart pen data integration partnership, announced at EASD 2019, went unmentioned. As of DTM 2019, Novo Nordisk’s smart pens are expected to launch in 2Q20, presumably beginning OUS.

Medtronic’s COVID-19 Efforts

It has been a busy time for Medtronic, as the company responds to COVID-19. Here are a few highlights of the company’s efforts, inside and outside of Diabetes. See this page for a full list.

  • In the US and Canada, Medtronic has expanded its financial assistance program for people affected by COVID-19. Eligible current customers will receive a three-month supply of pump supplies (glucose sensors, infusion sets, and reservoirs) at no cost. Individuals will be asked to “renew eligibility every three months through the program duration,” suggesting that the customers will be able to receive free (or at least, reduced cost) supplies beyond three months should they need them. To qualify, customers will need to provide: (i) documentation of job loss, (ii) documentation of insurance loss, and (iii) signed statement certifying they have no other source of insurance.

  • Medtronic Diabetes has moved all its call center employees (“1300+” employees) to working from home. Medtronic is directing customers to its newly updated Diabetes.shop online store to streamline supply ordering and moved patient trainings and demos to a virtual format.

  • Medtronic is sponsoring a study led by the T1D Exchange on the prevalence, presentation, and outcomes of COVID-19 in people with type 1 diabetes. Medtronic has also made a $1 million product donation to Insulin for Life USA. The donation includes sensors, infusion sets, and reservoirs, which Insulin for Life USA will distribute to patients on pump therapy experiencing “financial hardships” due to COVID-19. The company also told us they are making monetary and product donations to non-profits including CR3, Diabetes Will’s Way, DECA, and America Board for Child Diabetics. In total, Medtronic has donated over $36 million in monetary and product donations since February.

  • Medtronic’s Minimally Invasive Therapies Group has been a key player in increasing ventilator manufacturing. The company has released its Puritan Bennett 560 ventilator design specifications publicly and several large manufacturers have already begun work to manufacture these ventilators, Foxconn, Valus Medical, Walton Group, Tata Group, and Vingroup. Medtronic also aims to ramp its own production capacity to 1,000 per week by the “end of June,” a five-fold increase in its pre-pandemic capacity. Lastly, Medtronic worked with Intel to bring remote management capabilities to its ventilators to reduce healthcare workers’ exposure and brought a solution to market “in a matter of weeks.”

Q (Bob Hopkins, Bank of America): I was wondering if you could just offer up a quick comment on the upcoming Diabetes data that we're going to see at ADA, because I know in the past, you have commented that you do expect a Time in Range of around 80% and I'm just wondering if that is still the case.

A (Sean Salmon, Diabetes Group President): Yeah, thanks for the question, Bob. So, we'll have two datasets coming up at the virtual ADA, the first of which is going to be a randomized study out of New Zealand which serves as the CE Mark data, and the second one is the adult portion of the advanced hybrid closed-loop data which will be featured there. And, to your expectations for that, we really evaluated a number of different things in that study. Most importantly, we looked at targeting the glucose settings with patients with two different levels. One is the usual level that we have of 670G today, and the other one is a more aggressive, lower target, and we're evaluating the safety of that. So, as you look at those results, you'll see that there's really a lot to unpack there. But, we're very confident in the product and look forward to sharing the results next month.

 

--by Albert Cai and Kelly Close