The BEST Glycemic Control ToolYanhaijin11-02-2014

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

Hypoglycemia

Diminished cognitive function

Loss of consciousness

Potential Death

THE INTRICACY OF D/B MANAGEMENT Preferred Assessment: A1c Tests (Adult

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.

“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

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.

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.

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

COMPETITION: IT’S ALL ABOUT MARD

COMPETITION: IT’S ALL ABOUT MARDDEXCOM PRODUCT SUPERIORITY IS REFLECTED IN PATIENT CHOICE

Note: Close Concerns affiliate dQ&A QTR survey on 700+ pts.

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.

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

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

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.

FINANCIAL REVIEW

Note: The scales are not proportional.

CGM: HUGE OPPORTUNITIES LIE AHEAD

CLASSIC CASE: DXCM vs. GMCR

RAZOR

RAZORBLADE

MODEL Dexcom is here

MORE DISCUSSIONS (1)

MORE DISCUSSIONS (2)

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Phase 3 Results

Xtandi Approval

Thanks!Any questions?

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