The BEST Glycemic Control Tool. Yanhaijin

Transcription

1 The BEST Glycemic Control Tool Yanhaijin

2 DIABETES IS A GLOBAL EPIDEMIC -382 million people w/w have diabetes. (2012/IDF) -592 million people w/w will have diabetes. (2030/IDF) 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

3 THE INTRICACY OF D/B MANAGEMENT Preferred Assessment: A1c Tests (Adult <7%) But A1c tells NOTHING about glycemic variability Insulin Overdosing Insulin Underdosing Hypoglycemia Hyperglycemia Diminished cognitive function Cardiovascular disease Loss of consciousness Kidney Failure Potential Death Nerve degeneration Blindness PATIENTS NEED REFERENCE FOR INSULIN DOSING TO LOWER THE ACUTE AND CHRONIC COMPLICATIONS Note: the above analysis is based on T1D or insulin-dependent T2D patients.

4 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.

5 AND SEE THIS PARADIGM SHIFT 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. SENSOR APPLICATOR TRANSMITTER RECEIVER SHARE MOBILE GLUCOCLEAR

6 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, 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 event. Dexcom will seek for non-adjunctive label against BG thru several steps, could be a major reference for Medicare reimbursement decision.

7 THE CURRENT D/B LANDSCAPE TODAY S THERAPY OPTIONS $15-16b market w/w (2012) For T1D & insulin-dependent T2D patients Pump BGM/FGM CGM Roche LifeScan (JNG) Abbott Bayer Dexcom Medtronic Abbott (Defunct) Echo (ICU) Medtronic Animas (JNJ) Insulet Roche Tandem Asante T1D PENETRATION CGM: HSD-10% Note: Companies highlighted are Dexcom s partners. PUMP: 30%

8 THE CURRENT D/B LANDSCAPE FUTURE COMBO THERAPY OPTIONS For T1D & insulin-dependent T2D patients SENSOR AUGMENTED PUMP/APP INTEGRATION SINGLE PATCH ARTIFICIAL PANCREAS -Minimed Duo (mid-14) -Dexcom + Animas/Tandem -Insulet (15H1 human trial) -Dexcom participates in 18/20 AP projects w/w -Dexcom + Insulet/Asante (Authorized by Dexcom) -Becton Dickinson + JDRF ( Q2, project abandoned) -Medtronic internal projects Controversial route The ultimate loop closure -Medtronic Combo -Roche Combo Current preferred route Potential problems: -CGM sensor life and pump replacement cycle cannot be aligned. -Malfunctioning of one component leads to system replacement.

9 COMPETITION: IT S ALL ABOUT MARD

10 COMPETITION: IT S ALL ABOUT MARD DEXCOM PRODUCT SUPERIORITY IS REFLECTED IN PATIENT CHOICE Note: Close Concerns affiliate dq&a QTR survey on 700+ pts.

11 COMPETITION: A CLOSER LOOK AT MEDTRONIC THERE S LITTLE CHANCE MDT WILL CATCH UP WITH DXCM IN MARD TRAJECTORY 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 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. -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.

12 COMPETITION: SOME RELEVANT COMPETITORS AND THEN Abbott Freestyle Libre Roche internal CGM project -Approved in Sep Compelling data in 2014 ADA. MARD 8-10% vs. G % at excursion rate of ±1 mg/dl/min, 11-16% vs. 2530% at ± >3mg/dL/min. -Positioned btw BGM & CGM -MARD 11.4%, factory-calibrated -14d, Non-continuous, no alerts -Insurance reimbursement unclear -Project progress unclear, could be filed around or after G6 timeline Abbott Freestyle Navigator II Insulet single-site project -Available in Europe, but hard to get -CGM partner undisclosed -PMA Filing plan unclear, could be around G6 timeline -15H1 human trial, BD failed -MARD unclear (could be L-10s) -CGM sensor life will be limited to 3 days and malfunctioning of either component will lead to system replacement WE GOT THIS OVERWHELMING TOUTS AROUND NON-INVASIVE TECHNOLOGY MOVE ON TO REALITY CHECK NEXT PAGE

13 COMPETITION: NON-INVASIVE DREAM 50+ YEARS OF EFFORTS, 70+ COMPANIES HAVE FAILED TATTOO, TEARS, SWEAT, SALIVA, EYEBALL, CONTACT LENSES, EARLOBE, YOU NAME IT HG1-c Optical Glucose Monitor Quotes from C8 CEO: From a technological standpoint, what we had done -Broke down in 2013 due to unstable was a stellar achievement. But performance and mfg variability the problem was that the -Raman spectroscopy, Non-continuous performance was marginal, it -Extremely sensitive to sunlight, should was LIGHT YEARS from where be covered completely under clothes it needed to be for a product. -Received CE Mark in Oct-2012 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% -Affected by body hair and skin color Wild guess on iwatch Glucose Monitor -Apple hired former employee of C8 MediSensor -Numerous challenges ahead, wild guess is still wild guess 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 Smart contact lens -Secret CGM project starting from mid-2012, unveiled in early Novartis joined in mid Timeline unclear (at least 5 years) -Corr. btw glucose level in tears and blood are not proven, yet

14 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.

15 FINANCIAL REVIEW

16 CGM: HUGE OPPORTUNITIES LIE AHEAD Note: The scales are not proportional.

17 CLASSIC CASE: DXCM vs. GMCR RAZOR RAZORBLADE MODEL Dexcom is here

18 MORE DISCUSSIONS (1)

19 MORE DISCUSSIONS (2) Exparel Approval Xtandi Approval Phase 3 Results

20 Thanks! Any questions? You can find me at: