Glycemic Control Tool The BESTxqdoc.imedao.com/.../DexCom+PPT_YANHAIJIN_20141102.pdf · CGM...
Transcript of Glycemic Control Tool The BESTxqdoc.imedao.com/.../DexCom+PPT_YANHAIJIN_20141102.pdf · CGM...
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The BEST Glycemic Control ToolYanhaijin11-02-2014
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DIABETES IS A GLOBAL EPIDEMIC-382 million people w/w have diabetes. (2012/IDF)-592 million people w/w will have diabetes. (2030/IDF)-29.1 million people or 9.3% of the U.S. population have diabetes. (2012/CDC)-We estimate 1.5m T1D & 27.6m T2D. (2012)
Dexcom HQ
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Hypoglycemia
Diminished cognitive function
Loss of consciousness
Potential Death
THE INTRICACY OF D/B MANAGEMENT Preferred Assessment: A1c Tests (Adult
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LET’S DO THE MATH...
D/B pts typically spend >70% of their time outside euglycemia.
CGM generates 288 reads/day vs. SMBG 4-8 reads/ day.CGM delivers comprehensive information on glucose excursions.
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“CGM is the ONLY tool available to help patients continually track their glucose levels and alert them when
levels are too high or too low. ”
… AND SEE THIS PARADIGM SHIFT
SENSOR APPLICATOR TRANSMITTER RECEIVER SHARE MOBILE GLUCOCLEAR
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DEXCOM TIMELINE & PIPELINE
-Animas Vibe SAP is expected to be approved by YE14.
-Tandem t:slim G4 has submitted a PMA application in Mid-14, 12-18 months of review period are broadly expected by the market.
-G5’s (mobile integration) application strategy is TBD (ongoing dialogue w/ FDA), could be a whole package or separate filings including a PMA-S covering the latest algorithm.
-G6 will see sensor improvement in accuracy and membrane blocking of certain drug reaction (ICU), could be a 2016-2017 event. Dexcom will seek for ‘non-adjunctive’ label against BG thru several steps, could be a major reference for Medicare reimbursement decision.
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THE CURRENT D/B LANDSCAPETODAY’S THERAPY OPTIONS$15-16b market w/w (2012)
For T1D & insulin-dependent T2D patients
CGMDexcom
MedtronicAbbott (Defunct)
Echo (ICU)
BGM/FGMRoche
LifeScan (JNG)Abbott Bayer
PumpMedtronic
Animas (JNJ)InsuletRoche
TandemAsante
T1D PENETRATION
CGM: HSD-10% PUMP: 30%
Note: Companies highlighted are Dexcom’s partners.
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THE CURRENT D/B LANDSCAPEFUTURE COMBO THERAPY OPTIONS For T1D & insulin-dependent T2D patients
SENSOR AUGMENTED PUMP/APP INTEGRATION
-Dexcom + Animas/Tandem
-Dexcom + Insulet/Asante (Authorized by Dexcom)
-Medtronic Combo
-Roche Combo
SINGLE PATCH
-Minimed Duo (mid-14)
-Insulet (15H1 human trial)
-Becton Dickinson + JDRF (2010-14Q2, project abandoned)
ARTIFICIAL PANCREAS
-Dexcom participates in 18/20 AP projects w/w
-Medtronic internal projects
Current preferred route Controversial route
Potential problems:
-CGM sensor life and pump replacement cycle cannot be aligned.
-Malfunctioning of one component leads to system replacement.
The ultimate loop closure
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COMPETITION: IT’S ALL ABOUT MARD
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COMPETITION: IT’S ALL ABOUT MARDDEXCOM PRODUCT SUPERIORITY IS REFLECTED IN PATIENT CHOICE
Note: Close Concerns affiliate dQ&A QTR survey on 700+ pts.
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COMPETITION: A CLOSER LOOK AT MEDTRONICTHERE’S LITTLE CHANCE MDT WILL CATCH UP WITH DXCM IN MARD TRAJECTORY
-Medtronic is focused on complex and expensive AP system internally.
-Dexcom is SOLELY focused on simplified and miniaturized CGM product. Dexcom do all the heavy-lifting work around sensor accuracy, and leverage pump partners for SAP and ultimately, AP systems.
530G/Enlite: Low glucose Suspension based on preset threshold, 50%+ error rate. US launch in 13Q4. MARD ~18%.
640G/Enlite Enhanced: LGS based on predictive algorithm. US launch expected in 16H2. MARD 10-18%.
670G/Enlite 3: partially closed loop insulin delivery and suspension. US launch expected in Mid-2018. Targeting Single Digit MARD, and Dexcom has already achieved it NOW!
MM Flex: hybrid durable pump, can either be worn w/ or w/o tubing.
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COMPETITION: SOME RELEVANT COMPETITORS
Abbott Freestyle Libre
-Approved in Sep-2014
-Positioned btw BGM & CGM
-MARD 11.4%, factory-calibrated
-14d, Non-continuous, no alerts
-Insurance reimbursement unclear
Roche internal CGM project
-Compelling data in 2014 ADA. MARD 8-10% vs. G4 11-12% at excursion rate of ±1 mg/dL/min, 11-16% vs. 25-30% at ± >3mg/dL/min.
-Project progress unclear, could be filed around or after G6 timeline
Abbott Freestyle Navigator II
-Available in Europe, but hard to get
-PMA Filing plan unclear, could be around G6 timeline
-MARD unclear (could be L-10s)
Insulet single-site project
-CGM partner undisclosed
-15H1 human trial, BD failed
-CGM sensor life will be limited to 3 days and malfunctioning of either component will lead to system replacement
AND THEN
WE GOT THIS OVERWHELMING TOUTS AROUND NON-INVASIVE
TECHNOLOGY… MOVE ON TO REALITY CHECK NEXT PAGE
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COMPETITION: NON-INVASIVE DREAM50+ YEARS OF EFFORTS, 70+ COMPANIES HAVE FAILEDTATTOO, TEARS, SWEAT, SALIVA, EYEBALL, CONTACT LENSES, EARLOBE, YOU NAME IT
HG1-c Optical Glucose Monitor
-Received CE Mark in Oct-2012
-Broke down in 2013 due to unstable performance and mfg variability
-Raman spectroscopy, Non-continuous
-Extremely sensitive to sunlight, should be covered completely under clothes
-Affected by body hair and skin color
Symphony tCGM system
-Used in OR/ICU setting
-PMA Application filed in Mid-13
-Prelude SkinPrep removes the Stratum Corneum
-ICU trials’ average MARD 11.9%
Smart contact lens
-Secret CGM project starting from mid-2012, unveiled in early 2014
-Novartis joined in mid-2014
-Timeline unclear (at least 5 years)
-Corr. btw glucose level in tears and blood are not proven, yet
Wild guess on iWatch Glucose Monitor-Apple hired former employee of C8 MediSensor-Numerous challenges ahead, wild guess is still wild guess
Quotes from C8 CEO:
“From a technological standpoint, what we had done was a stellar achievement. But the problem was that the performance was marginal, it was LIGHT YEARS from where it needed to be for a product.”
GlucoTrack-Received CE Mark in June-’13, US trial starts in ‘14-Ear-clip, 1st generation non-continuous, but do PWDs really wanna wear this bulky clip as CGM?-MARD probably around 20-30%-Redundant sensing, thermal/ultrasound/EM tech
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CGM Reimbursements
-Covered by 98% of private insurers for T1D.
-Covered by 25% of private insurers for T2D.
-Medicare coverage should be expected after G6 launch. (~⅓ T1D are eligible for Medicare).
G4 Distribution
-In 14H2-15H1, G4 will lock down its preferred position in Express Script’s drug formulary as the ONLY CGM product in d/b category.
-G4 has also entered into collaboration with CVS and two other major PBMs (could be Catamaran and United Health).
-Transition from DME benefit to pharmacy benefit simplifies the purchase and reimbursement process for d/b patients.
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FINANCIAL REVIEW
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Note: The scales are not proportional.
CGM: HUGE OPPORTUNITIES LIE AHEAD
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CLASSIC CASE: DXCM vs. GMCR
RAZOR
RAZORBLADE
MODEL Dexcom is here
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MORE DISCUSSIONS (1)
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MORE DISCUSSIONS (2)
Exparel Approval
Phase 3 Results
Xtandi Approval
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Thanks!Any questions?
You can find me at:
weibo @yanhaijin