Memorandum

JP Morgan Healthcare Conference 2016 Preview – January 5, 2016

January 11-14, 2016 – Westin St. Francis, San Francisco, CA

Our team is looking forward to kicking off our annual conference slate by making the short journey down the road to San Francisco’s Westin St. Francis Hotel for JP Morgan’s 34th Annual Healthcare Conference (boy are we happy this is in our hometown every year!). The packed agenda features ~450 presentations over four days, spanning Monday, January 11 to Thursday, January 14 and of course there’s lots happening on Sunday as well. Below, we’ve highlighted the ~53 companies and organizations relevant to diabetes and obesity, slightly higher than the number we’ve identified in past years [~50 in 2015 and ~47 in 2014].

Who will we hear from? Public companies include Abbott, AbbVie, Amgen, AstraZeneca, Baxter, Bayer, Becton Dickinson, Dexcom, Express Scripts (new in 2016), Gilead, GlaxoSmithKline, Halozyme, Insulet, Ionis (formerly Isis), J&J, Lexicon, Lilly, MannKind, Medtronic, Merck, Mesoblast, Novartis, Orexigen, Pfizer, Roche, Sanofi, Takeda, and Zealand (new in 2016). Of note on the private-company side is Intarcia, ReShape Medical, OneMedicalGroup, and 23andMe. Notable non-profits making appearances include Cleveland Clinic and Geisinger Health System among others.

Per usual, conference organizers have put together an impressive keynote lineup featuring J&J CEO Mr. Alex Gorsky, Bill & Melinda Gates Foundation powerhouse (and former head of UCSF) CEO Dr. Susan Desmond-Hellmann, and JP Morgan CEO Mr. Jamie Dimon (twice). We also look forward to a Monday night “digital health” panel discussion (a staple of JPM) and a Tuesday night discussion with CMS and AMA (the American Medical Association) on the evolving healthcare market.

Our preview below highlights the times and locations of JPM presentations, the subsequent Q&A breakout sessions (often the biggest highlight for updates), and links to our most recent coverage. Public company presentations should be webcast through the Investor Relations section of company websites. Please note that the schedule for JPM often changes, so please check the final version if you are coming in person. The below is based on the mid-December schedule, though we will update it as new versions are released.

We’ll also be attending three smaller conferences of note next week:

  • Biotech Showcase 2015 and Digital Health Showcase will also take place in downtown San Francisco, held at the nearby Parc 55 Wyndham Hotel. Presenting companies related to diabetes include Bigfoot Biomedical, mySugr, WellDoc, NeuroMetrix, ViaCyte, IM Therapeutics (type 1 cure research), Midatech (transbuccal insulin and GLP-1 pipeline program), Poxel (type 2 drug aimed at mitochondrial dysfunction), Cymabay (GPR119 agonist for type 2), Metabolic Solutions Development Company (insulin sensitizers), Resverlogix (CVD drug in diabetes), Diapin (amino-acid peptide for type 2), and Viking (recently deprioritized its type 2 drug). Organizers have also scheduled two Wednesday morning workshops to discuss the current state of FDA regulatory efforts in healthcare and the intersection of healthcare and technology – the latter features WellDoc CEO Mr. Kevin McRaith.
  • Health 2.0 WinterTech on Wednesday January 13 at the Julia Morgan ballroom will focus on digital health investing. The major highlights are a demo from Bigfoot Biomedical’s Jeffrey Brewer and interviews with Omada CEO Sean Duffy and Livongo CEO Glen Tullman.

 

Detailed Discussion and Commentary

JP Morgan Healthcare Conference

Monday, January 11

  • 8:00 AM: Perrigo presents in Colonial Room (breakout in Georgian Room). Read our Perrigo F1Q16 report.
  • 8:00 AM: Neurocrine presents in California West (breakout in Olympic Room). Read our Neurocrine 3Q15 report.
  • 8:30 AM: Abbott presents in Grand Ballroom (breakout in Borgia Room). Read our Abbott 3Q15 report and see our IDF coverage of FreeStyle Libre. We’re looking particularly forward to hearing more about the US regulatory status of FreeStyle Libre as well as capacity worldwide – it’s really a problem for so many globally where FreeStyle Libre is approved to get their hands on it and with the new year, we hope to hear something more conclusive on this front. It’s a high-class problem, with the world eager for the product – although many can’t access it now we continue to think of it as a “once a decade” product and believe it could be particularly important for research, especially given its ease of use, quick set up, etc. The world’s regulatory bodies would of course all have to agree, which hasn’t happened yet.
  • 9:00 AM: Novartis presents in Grand Ballroom (breakout in Borgia Room). Read our Novartis 3Q15 report. We look forward to hearing, ideally, at least reference to the important work being done on the type 1 cure front as well as at Alcon in relation to the Verily (formerly Google Life Sciences) work.
  • 9:00 AM: Intarcia Therapeutics presents in Elizabethan C/D. At last year’s JPM, Intarcia shared a glimpse of new data from its phase 3 FREEDOM-1 trial for its implantable exenatide mini-pump, ITCA 650. Most recently, the team disclosed topline results from the FREEDOM-2 trial in August that showed a significantly greater A1c reductions (1.5% vs. 0.8%; p<0.001) and weight loss with ITCA 650 vs. Merck’s Januvia (sitagliptin).
  • 9:30 AM: Medtronic presents in Grand Ballroom (breakout in Borgia Room). Read our Medtronic F2Q16 report. Last year this was among the biggest news of JPM, as the company shared its ambitious US launch timelines to commercialize the 640G by April 2016 and the 670G by April 2017. The 640G has not been submitted to the FDA (they have only four months to get it submitted and launched to hit the timeline), while the 670G is in its pivotal study, slated to wrap up in May – the latter is particularly exciting.
  • 9:30 AM: Geisinger Health System presents in Alexandra’s Room on the 32nd floor. We’re trying to learn more about what is happening in systems like Geisinger’s on the diabetes front where value is all-important.
  • 10:30 AM: Gilead presents in Grand Ballroom (breakout in Borgia Room). Read our Gilead 3Q15 report. We’d love to hear an update on what’s happening with the company’s phase 2 study of ASK-1 inhibitor GS-4997 in diabetic nephropathy. We’ve been waiting for some time for an update on whether Gilead will pursue a type 2 diabetes indication for its sodium current inhibitor Ranexa (ranolazine; approved for angina) and it would also be great to glean any clues on this, probably in the breakout.
  • 11:00 AM: Partners Health System presents in Alexandra’s Room on the 32nd floor – this is another system we’re eager to hear highlights on for any clue on how people with diabetes could be doing better.
  • 12:00 PM: Luncheon and Keynote with JP Morgan CEO Mr. Jamie Dimon, J&J CEO Mr. Alex Gorsky, and Bill & Melinda Gates Foundation CEO Dr. Susan Desmond-Hellmann in Grand Ballroom. Dr. Desmond-Hellmann is extremely highly regarded for her previous leadership at UCSF and with her at the mantle of The Bill & Melinda Gates Foundation, we have very high hopes and expectations for the foundation’s commitment to improving healthcare globally.
  • 1:30 PM: 23andMe presents in Elizabethan C/D. Read our coverage from JP Morgan 2013 and our recent interview with Dr. Anne Peters. We hope to hear more on when the system will re-emerge.
  • 2:30 PM: Johnson & Johnson presents in Grand Ballroom (breakout in Borgia Room). Read our J&J 3Q15 report. We look for any new learnings on the Invokana front as well as to hear anything on the medical device front, particularly related to Calibra or the company’s work on the closed loop. CMS’ decimation of any decent reimbursement for strips has, of course, hampered R&D massively – a major problem for all strip manufacturers and thus for patients looking for investment in R&D.
  • 2:30 PM: Isis Pharmaceuticals (recently renamed “Ionis Pharmaceuticals”) presents in California West (breakout in Olympic Room). Read our Isis 3Q15 report. We are looking to hear more about Ionis’ phase 2 trial of its glucagon receptor antagonist ISIS-GCGRRx in type 2 diabetes as well as the recently-initiated phase 1 trial for ISIS-DGAT2Rx, which it plans to develop for NASH (another major unmet need for patients). Ionis is also working on development of more potent, better-tolerated next-generation drugs and we hope for more specifics on this front, as well as more from the company on its partnership with AZ on the companies’ cardiometabolic and renal partnership (Ionis management suggested in 2Q15 that the kidney would be the primary focus).
  • 3:00 PM: Merck presents in Grand Ballroom (breakout in Borgia Room). Read our Merck 3Q15 report. We expect to hear more about how the company’s Januvia (DPP-4 inhibitor) franchise is going as well as, hopefully, more on pipeline products including biosimilar insulin and smart insulin.
  • 3:00 PM: Cleveland Clinic presents in Alexandra’s Room on the 32nd floor. Read our coverage of the 2015 Cleveland Clinic Obesity Summit. Wellness is a major focus at the Cleveland Clinic and as costs from diabetes and obesity expand further, we’ll be interested to hear what the last year’s learnings from the Cleveland Clinic have been. The Cleveland Clinic benefits in many respects from diabetes’ worst complications like cardiovascular disease – we’d love to hear more from the nonprofit on what it is doing at a population level on the prevention front.
  • 3:30 PM: Express Scripts presents in Colonial Room (breakout in Georgian Room).
  • 4:00 PM: Baxter presents in Grand Ballroom (breakout in Borgia Room). Read our Baxter 3Q15 report. We look to hear broad commentary from Baxter on the status of the dialysis market. 
  • 5:00 PM: Digital Health Panel: A discussion with leading digital health companies on the future of healthcare in Colonial Room. We’re not yet sure who has been invited to speak but will update this document as more information becomes available. This should be very interesting to see how the body language is evolving by nascent and more established companies in the field, particularly coming out of the CES meeting, which is actually before JP Morgan this year.

Tuesday, January 12

  • 7:30 AM: CVS Health presents in Grand Ballroom (breakout in Borgia Room). Read some of our recent coverage here, here, and here. CVS Health is known for the leadership of Ms. Helena Foulkes, who is best known for kicking tobacco out of their shops. From what we understand, even smokers have thanked the retail giant for this move, which reduced revenue by $2 billion but “righted” the company in terms of its philosophical approach to healthcare.
  • 8:00 AM: Amgen presents in Grand Ballroom (breakout in Borgia Room). Read our Amgen 3Q15 report. We expect to hear more on PCSK9 inhibitor Repatha (evolocumab) – highly regarded CEO Mr. Bob Bradway characterized the product on the last call as representing particularly significant opportunities for patients and shareholders. In the breakout we’d love to learn more about what people with diabetes who can’t take statins expect – we see this as a particularly needy group - how it is defined stands as an unanswered question at present.
  • 9:00 AM: Roche presents in Grand Ballroom (breakout in Borgia Room). Read our Roche 3Q15 report. We look forward to hearing the outlook for the medical device arena and diabetes diagnostics in particular.
  • 9:30 AM: BMS presents in Grand Ballroom (breakout in Borgia Room). Read our BMS 3Q15 report. This company doesn’t really still have anything to do with diabetes though we’d like to know where it stands on the partnership with Biocon as well as what it’s doing with metformin patents, which could be very useful to the community.
  • 9:30 AM: GSK presents in Colonial Room (breakout in Georgian Room). Read our GSK 3Q15 report. The company hasn’t been saying much of late about its GLP-1 agonist Tanzeum/Eperzan (albiglutide) or its diabetes pipeline products in general. The 3Q15 announcement no longer listed type 2 diabetes as a potential indication for GSK’s phase 2 ileal bile acid transport inhibitor GSK2330672 – perhaps unsurprisingly given the increasingly high bar for new type 2 diabetes drugs. GSK’s unexpectedly reinitiated clinical development for anti-CD3 therapy otelixizumab for new onset type 1 diabetes is ongoing and we’d love to hear anything even broadly related to this though the phase 2 trial won’t complete until 2021 according to ClinicalTrials.gov. Phase 2 studies for albiglutide in type 1 diabetes and motilin receptor agonist camicinal in delayed gastric emptying (presumably including diabetic gastroparesis) remain ongoing.
  • 10:00 AM: Sanofi presents in Grand Ballroom (breakout in Borgia Room). Read our Sanofi 3Q15 report. We’ll look forward to hearing more from the insulin giant on its insulin and GLP-1 businesses – pricing will no doubt come up as a major question. CEO Mr. Olivier Brandicourt will be presiding and we’ll be interested in how he splits the time in talking about diabetes, cardiovascular disease – particularly on PCSK-9 Praluent, and the company’s pipeline broadly speaking. On the pipeline front, Sanofi submitted its GLP-1 agonist/basal insulin fixed-ratio combination LixiLan (lixisenatide/insulin glargine) for US approval on Christmas Eve – it should be approved within six months and we look forward to hearing more about this as we believe this therapy could be started earlier than insulin in patients not in good control and the duration will presumably be longer than basal insulin only, which could be a major benefit to patients accustomed to hopping on and off various therapies. It has also added a GLP-1/GIP receptor dual agonist to its phase 1 pipeline. 
  • 10:00 AM: Insulet presents in Elizabethan A/B (breakout in Sussex Room). Read our Insulet 3Q15 report. It will be interesting to hear from data-driven CEO Pat Sullivan about what will drive the pump markets and Insulet’s revenue in particular – international revenue hadn’t changed much in 3Q15 from the start of 2014, though US revenue grew about 20% over that time. Drug delivery is clearly a major focus of the new management team (hardly anyone is left from the old Insulet management team led by Mr. Duane DeSisto) and it will be interesting to hear about progress.
  • 10:30 AM: Pfizer presents in Grand Ballroom (breakout in Borgia Room). Read our Pfizer 3Q15 report. We’d love to hear more about the SGLT-2/DPP-4 inhibitor fixed dose combination drug in the works with Merck. 
  • 11:00 AM: Henry Ford Health System presents in Alexandra’s Room on the 32nd floor. This is where noted educator Ms. Davida Kruger works – we’d love to hear more on the research and operational fronts.
  • 11:30 AM: Takeda presents in Colonial Room (breakout in Georgian Room). Read our Takeda F2Q15 report. Takeda has been the recipient of poor luck from FDA, of course, and most of its focus on the DPP-4 inhibitor front is outside the US at this stage, given its late approval here. Takeda invested only a small amount in Orexigen historically and the slow pace of the obesity market has also not benefited the company – we’d love to hear from the very smart management team how obesity globally should be addressed.
  • 11:30 AM: OneMedicalGroup presents in Elizabethan C.
  • 12:00 PM: Luncheon and Keynote with JP Morgan CEO Mr. Jamie Dimon in Grand Ballroom.
  • 2:30 PM: Mylan presents in Colonial Room (breakout in Georgian Room). Read our Mylan 3Q15 report.
  • 3:30 PM: Lilly presents in Grand Ballroom (breakout in Borgia Room). Read our Lilly 3Q15 report. We should hear about the broadest product portfolio today in diabetes – in particular, we are eager for more on SGLT-2 Jardiance, once-weekly GLP-1 Trulicity, and the company’s biosimilar in waiting (in the US) Abasaglar (Basaglar in the US). Like with Sanofi, insulin pricing will no doubt come up as a topic of interest. During Lilly’s 3Q15 Q&A, CEO Mr. John Lechleiter spoke candidly on how he felt the pharmaceutical industry should respond to the increasing public and political outcry over drug prices –Mr. Lechleiter is one of our very favorite CEOs to hear from during JP Morgan (we do wish Novo Nordisk would come as well!) and we know we’ll learn a great deal at this gathering. A bonus would be to hear, at least in the breakout, plans for pipeline products like recently acquired (the assets!) of hypoglcyemia agent Locemia.
  • 3:30 PM: Dexcom presents in Colonial Room (breakout in Georgian Room). Read our Dexcom 3Q15 report. Mr. Kevin Sayer did a brilliant job last year in his first JPM as CEO of Dexcom and we expect more this year as we hear more on the G5 launch, G5 capacity (we’ve heard more than a few complaints of late from patients very eager to get their hands on more sensors – a good problem of sorts, of course but frustrating to patients), the move to distribute more sensors through pharmacies (this will go to over 70% of total distribution by 2018), and of course, Dexcom’s partnership with Verily, formerly Google Life Sciences. As a reminder, Dexcom said last summer that the first product from the partnership would launch in the 2017-2018 time period, with a follow-on by 2020. We first heard about Dexcom’s new insertion system last year and this time and would love to see an update on this and other pipeline fronts such as the insulin dosing claim and G6 status. The insulin dosing claim is a big one to get to help toward Medicare reimbursement and the G6 timing is something on which the field is looking for an update, particularly on the FDA submission front, which was targeted last summer for early this year.
  • 4:00 PM: AstraZeneca presents in Grand Ballroom (breakout in Borgia Room). Read our AstraZeneca 3Q15 report. We’ll look forward to hearing what is happening in the growing GLP-1 market as well as to hear more on the expanding SGLT-2 market. We hope to hear more on the pipeline, particularly on once-monthly Bydureon, which we haven’t heard about in some time.
  • 5:00 PM: A Discussion with CMS & the American Medical Association (AMA) on the Evolving Healthcare Market. In Grand Ballroom. This is not to be missed, of course.
  • 5:00 PM: A Closer Look at Consumer Genomics. In Colonial Room.

Wednesday, January 13

  • 8:30 AM: AbbVie presents in Grand Ballroom (breakout in Borgia Room). Read our AbbVie 3Q15 report. We would love to hear more about the kidney drug market and how things are evolving for AbbVie – our sense is that there is more competition than ever in this extremely competitive arena.
  • 9:00 AM: BD presents in Grand Ballroom (breakout in Borgia Room). Read our BD F4Q15 report. We always learn a great deal about diabetes broadly speaking from the company’s CEO Mr. Vincent Forlenza. A new study on ClinicalTrials.gov (Identifier: NCT02271594) will investigate the impact of optimized injection technique on lipohypertrophy in type 1 and type 2 insulin-treated patients. We look for ongoing growth going forward at BD as GLP-1 agonists expand, as a larger population of patients move to insulin, as patients move onto injectables for a longer period of time, and as BD moves into infusion sets and potentially patch delivery devices. On the R&D front, BD shared in its last quarterly call that its FlowSmart infusion set is on track to launch “in the middle of fiscal year 2016” in collaboration with Medtronic and we will be looking for any updates or confirmations on this front – we think commercialization could come around March or April this year and we’ll be interested to see how negative the impact is on other pump manufacturers; Medtronic agreed to move forward with distribution on this set, as we understand it, only if it could have the exclusive. We were very happy to see more focus on insulin sets and believe that more innovation will be forthcoming.
  • 11:30 AM: Bayer presents in Colonial Room (breakout in Georgian Room). Read our Bayer 3Q15 report. Bayer Diabetes Care has split off from the company, of course, and is now controlled by Panasonic and KKR.
  • 12:00 PM: Luncheon and Keynote with FOX and Friends Weekend Co-Host Tucker Carlson in Grand Ballroom.  
  • 2:30 PM: ReShape Medical presents in Elizabethan D. Read our recent coverage of ReShape.
  • 3:30 PM: MannKind presents in California East (breakout in Yorkshire Room). Read our MannKind 3Q15 report. This talk will be led by new CEO Mr. Duane DeSisto – he was always addressing challenges at Insulet so the terrain he’ll be facing at MannKind will be familiar. We look forward to hearing how much of the old team he will try to bring back together – most have left Insulet some time ago.
  • 3:30 PM: Mesoblast presents in Elizabethan B (breakout in Elizabethan C). Read our recent coverage of Mesoblast. Diabetes Care recently published online before print full results from a phase 2 trial of Mesoblast’s mesenchymal precursor cell (MPC) treatment for type 2 diabetes aimed at reducing inflammation. We were glad to see reassuring safety results and look forward to seeing efficacy results from more robust trials that we hope to hear about at JP Morgan. Stem cell treatments are a hot topic in diabetes treatment right now, though most therapies in the pipeline are focused on type 1 diabetes (see Melton group and ViaCyte). Mesoblast is also currently in phase 2 trials investigating MPCs as a diabetic nephropathy treatment – we look forward to hearing about this as well, particularly about how outcome measures will be examined.

Thursday, January 14

  • 9:00 AM: Arena presents in Elizabethan B (breakout in Kent Room). ). Read our Arena 3Q15 report. We expect to hear more about obesity market prospects big picture – the obesity market 2015 revenues will be available following the January quarterly reporting season. The field needs some catalysts, but is hampered by many issues, particularly PCP understanding of how to best treat obesity.
  • 10:00 AM: WebMD presents in Colonial Room (breakout in Georgian Room).
  • 10:00 AM: Orexigen presents in Elizabethan A (breakout in Sussex Room). Read our Orexigen 3Q15 report. See our comments on the obesity market above.
  • 10:30 AM: Zealand presents in Elizabethan A (breakout in Sussex Room). Read our Zealand 3Q15 report. We look forward to getting an update on all Zealand’s partnerships as well as an update on Lixilan, which was submitted to the FDA on Christmas Day (see Sanofi, above). This is the product that Zealand shareholders have been waiting for! It will be a showdown between Sanofi and Novo Nordisk who gets the early lead in the powerful GLP-1/basal insulin combo products – we feel we’ve been writing about these high-potential products forever and it will be great to see how they do in the final months before approval in the US, at the FDA, and in the early launch periods. CEO Ms. Britt Meelby Jensen recently highlighted Zealand’s refreshed company strategy at the company’s recent Capital Markets Day in New York, NY – we really admire this CEO and look forward to her thoughts on the field.
  • 11:00 AM: Lexicon presents in California East (breakout in Yorkshire Room). Read our Lexicon 3Q15 report. We expect CEO Mr. Lonnel Coates, former CEO of Easai, to discuss the new partnership with Sanofi at some length as well as prospects for SGLT-2 for type 1. We continue to believe potential is high and that the “management” of DKA in type 1 patients taking SGLT-2s off-label must be managed more aggressively – education is paramount, which will be easier once there is at least one drug with an indication for type 1. We last heard in November that enrollment for the sotagliflozin phase 3 program in type 1 diabetes was progressing ahead of schedule and we’ll be eager to hear if that is still the case.

Biotech Showcase and Digital Health Showcase

Below is a list of presenting companies with products/programs related to diabetes. Please note that the Biotech Showcase and Digital Health Showcase is not held at the Westin St. Francis, but rather at the nearby Parc 55 Wyndham Hotel at 55 Cyril Magnin Street.

Monday, January 11

  • 10:30 AM: IM Therapeutics presents in Hearst Room. ImmunoMolecular Therapeutics is a private clinical stage company whose goal is to develop a cure for type 1 diabetes. This is the first we have heard of the company, though it boast an impressive leadership team including a number of researchers from the Barbara Davis Center.
  • 11:00 AM: ViaCyte presents in Davidson Room. ViaCyte is developing a stem cell-derived islet replacement therapy for type 1 diabetes (pancreatic progenitor cells encapsulated in an immune protective device, implanted under the skin). The program is in a phase 1/2 trial that is expected to wrap in 2017.
  • 2:00 PM: Midatech presents in Market Street Room. This small nanomedicine company is focused on the development of proprietary drug conjugate and sustained-release delivery platforms with a focus on diabetes, cancer, and neuroscience/ophthalmology. The company’s lead product is MidaForm Insulin, a transbuccal insulin that is delivered via a self-dissolving oral postage stamp-sized strip, that recently entered a phase 2a trial.
  • 5:00 PM: Poxel presents in Mission II Room. The company is developing a pipeline of products focused on type 2 diabetes; its lead product – imeglimin – targets mitochondrial dysfunction and has successfully completed phase 2 development in the US and EU.

Tuesday, January 12

  • 3:00 PM: Cymabay presents in Powell Room. Cymabay is a San Francisco-based biopharmaceutical company with a GPR119 agonist development program focused on type 2 diabetes. The candidate has completed four phase 1 studies and one phase 2 study.
  • 3:30 PM: NeuroMetrix presents in Mission II Room. The company reported diabetes portfolio revenue of $1.5 million in 3Q15 plus deferred Quell revenue of $680,000. The performance marked an all-time record reflecting the success of Quell’s recent launch in 2Q15.
  • 5:15 PM: Metabolic Solutions Development Company presents in Davidson Room. This drug discovery and development company has two insulin sensitizers, MSDC-0160 and MSDC-0602, in its pipeline. The first candidate has been investigated in a 90-day, randomized, double-blind, placebo-controlled phase 2b clinical study in 258 patients with type 2 diabetes while the second has been evaluated in a 28-day, randomized, double-blind, phase 2a study in 129 patients with type 2 diabetes. These studies were both completed in 2011 and we’re not sure what the current status of the candidates is.

Wednesday, January 13

  • 8:00 AM: FDA 2016: New FDA Commissioner, PDUFA Reauthorization Process and Biomarkers. This workshop will be held in Room Mission I on Level 4 and will address the most pressing regulatory questions facing the FDA in 2016. Representatives from the Agency will not be presenting though we are very curious to hear what the future will hold under the new FDA leadership that we expect to be announced shortly.
  • 8:00 AM: At The Intersection of Technology and Medicine. This workshop will be held on Level 3 (we are not yet sure of the room) and will discuss the promise of digital health in the context of the field’s many challenges. The convergence of medicine and technology became an increasingly hot topic in 2015, and we are particularly excited to hear from WellDoc CEO Mr. Kevin McRaith what he sees as the future evolution of healthcare.
  • 9:00 AM: Bigfoot Biomedical presents in Market Street. Startup Bigfoot Biomedical became a serious closed-loop contender in 2015 under the leadership of CEO Jeffrey Brewer, CTO Bryan Mazlish, Chief Engineer Lane Desborough, CFO Jon Brilliant, and Director of Clinical Innovation Jen Block. Following our breakout interview in February, the company raised $3.5 million and $4.6 million in two separate deals, signed a CGM development agreement with Dexcom, and acquired all of pump-maker Asante’s assets when the latter shut its doors in May. The latter deal gave Bigfoot an FDA-approved pump to use in its automated insulin delivery system and gave real teeth to the goal of building a system, conducting a pivotal study, submitting a PMA, and commercializing an offering in the next few years. We heard a few snippets of product details last year, including plans to leverage smartphones, build a “service” rather than just a “device,” and appeal to the majority of patients that don’t use pumps and CGMs. Very ambitious! As of the latest update, Bigfoot plans to be in a pivotal trial by the end of 2016, meaning it could closely follow Medtronic’s MiniMed 670G and potentially even leapfrog other pump companies.
  • 9:30 AM: WellDoc presents in Market Street. The diabetes digital health company most recently raised $22 million in Series B financing in December led by Samsung Ventures and Merck’s Global Health Innovation fund. The funds will broaden the regional launch of WellDoc’s BlueStar software for type 2 diabetes beyond the mid-Atlantic US. Since launching in 2Q14, WellDoc has called on almost 1,000 prescribers, and a striking 55% have written a prescription for BlueStar. Almost 10,000 prescriptions have been written since launch. Why hasn’t BlueStar scaled faster? (i) It was essential to gather real-world data and experience to iterate the BlueStar product and develop the operations model; (ii) the regional launch taught WellDoc how to best approach physicians; and (iii) payer discussions have evolved over the past year. More here.
  • 10:00 AM: Resverlogix presents in Powell Room. The company is developing a BET inhibitor, RVX-208, for cardiovascular disease and recently announced the initiation of a phase 3 trial in patients with type 2 diabetes and coronary artery disease.
  • 10:15 AM Diapin presents in Hearst Room. – Diapin Therapeutics is a drug development company founded in 2011 to develop an amino-acid peptide for the treatment of type 2 diabetes. We assume research is still preclinical at this point.
  • 2:00 PM mySugr presents in Market Street. As noted in our DTM 2015 coverage, mySugr has developed an ecosystem of diabetes logging and educational apps. The mySugr logbook app has seen good patient traction: 435,273 cumulative users worldwide, and a strong 150,000 active users every month. mySugr is among just a handful of apps in the dQ&A patient panel that more than 50% of its type 1 users consider “indispensable”; contact CEO of the diabetes market research company Richard Wood. In a rarity for a digital health company, mySugr also has a revenue model – the app is free, though paying $2.99 per month gives access to a slew of Pro features. mySugr has established commercial agreements for bulk licensing, communication, and advertising, and select payer and provider reimbursement (Austria only). The company has followed strict CE, FDA, and ISO13485 clinical guidelines (also rare for an app), raised $4.8 million in March 2015, and has hired industry veteran Kyle Rose (formerly of TheraSense) to lead operations in North America.
  • 2:30 PM: Viking presents in Powell Room.  Viking’s former lead candidate VK0612 for type 2 diabetes was recently deprioritized in favor of candidates for hip fracture recovery, hypercholesterolemia, and a rare neurological disorder. Read our 2Q15 report.

Health 2.0 WinterTech: Focusing On Digital Health Investing

This one-day conference will take place in the Julia Morgan Ballroom in downtown San Francisco (465 California Street, a few blocks from JP Morgan at the Westin St. Francis) on Wednesday, January 13.

Wednesday, January 13

  • 1:35 PM: Meeting in the Middle: The Convergence of Life Sciences and Health Tech. This one-hour session will include a demo from Bigfoot Biomedical CEO Jeffrey Brewer. We’ve only heard snippets about Bigfoot’s automated insulin delivery system, so this demo could reveal the most detail we’ve heard yet. Per the most recent update, the company plans to enter a pivotal trial later this year.
  • 3:00 PM: 3 CEOs. Livongo Health CEO Glen Tullman and Omada Health CEO Sean Duffy will each participate in 15-minute interviews with tech journalists (KQED’s Christina Farr and DNAnexus’ David Shaywitz).  

 

-- by Varun Iyengar, Adam Brown, and Kelly Close