valeritas investor presentation
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CONFIDENTIAL – AUTHORIZED USE ONLY
D E L I V E R I N G Q U A L I T Y O F L I F E
John Timberlake, President & CEO April 2016
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2
Forward Looking Statements
This presentation shall not be deemed an offer to sell securities nor a solicitation of an offer to purchase securities. Any sale by the company shall be made pursuant to a definitive purchase agreement. Unless otherwise stated in this presentation, references to “Valeritas,” “we,” “us,” “our” or “our company” refer to Valeritas, Inc.
This presentation contains estimates, projections and forward-looking statements. Our estimates, projections and forward-looking statements are based on our management’s current assumptions and expectations of future events and trends, which affect or may affect our business, strategy, operations or financial performance. Although we believe that these estimates, projections and forward-looking statements are based upon reasonable assumptions and expectation, they are subject to numerous known and unknown risks and uncertainties and are made in light of information currently available to us. Many important factors may adversely and materially affect our results as indicated in forward-looking statements. All statements other than statements of historical fact are forward-looking statements. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and similar words are intended to identify estimates, projections and forward-looking statements. Estimates, projections and forward-looking statements speak only as of the date they were made, and, except to the extent required by law, we undertake no obligation to update or review any estimate, projection or forward-looking statement because of new information, future events or other factors. Our estimates, projections and forward-looking statements may be influenced by one or more of the following factors: ▫ our history of operating losses and uncertainty regarding our ability to achieve profitability; ▫ our reliance on V-Go Disposable Insulin Delivery Device, or V-Go, to generate all of our revenue; ▫ our inability to retain a high percentage of our patient customer base or our significant wholesale customers; ▫ the failure of V-Go to achieve and maintain market acceptance; ▫ our inability to operate in a highly competitive industry and to compete successfully against competitors with greater resources; ▫ competitive products and other technological breakthroughs that may render V-Go obsolete or less desirable; ▫ our inability to maintain or expand our sales and marketing infrastructure; ▫ any inaccuracies in our assumptions about the insulin-dependent diabetes market; ▫ manufacturing risks, including risks related to manufacturing in Southern China, damage to facilities or equipment and failure to
efficiently increase production to meet demand; ▫ our dependence on limited source suppliers and our inability to obtain components for our product; ▫ our failure to secure or retain adequate coverage or reimbursement for V-Go by third-party payers; ▫ our inability to enhance and broaden our product offering, including through the successful commercialization of the pre-fill V-Go; ▫ our inability to protect our intellectual property and proprietary technology; ▫ our failure to comply with the applicable governmental regulations to which our product and operations are subject; ▫ our ability to operate as a going concern; and ▫ our liquidity.
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V-Go®: The Ideal Insulin Delivery Device For Patients with Type 2 Diabetes
▫ The only FDA-cleared single-use, fully disposable insulin delivery device with basal (background) and bolus (meal time) capability on the market in the US
▫ Clinically proven to effectively lower glucose levels
▫ Small, discreet, disposable and easy-to-use
▫ Convenient drug-like distribution model
▫ Established and attractive pharmacy reimbursement
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John Timberlake President & Chief Executive Officer
25 / 9
Geoffrey Jenkins EVP Manufacturing, Operations, R&D
30 / 7
Matt Nguyen SVP Commercial
20 / 9
Mark Conley VP Corporate Controller & Treasurer
30 / 4
The Valeritas Leadership Team Extensive and Proven Track Record of Success in Diabetes
Years Experience Industry / Valeritas
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Valeritas: Our Key Drivers For Success In Type 2 Diabetes
De-Risked and Demonstrated Commercial Traction
V-Go® was Specifically Designed to Address Unmet Needs in the Large Type 2 Diabetes Market
The Only FDA-Cleared Mechanical Basal–Bolus Insulin Delivery Device – Critical for Type 2 Patients in the US
Established Pharmacy Reimbursement and Distribution with Attractive Cost-Benefit Profile
Capital Efficient Strategy Positioned for Growth
1
2
3
4
5
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De-risked and Demonstrated Commercial Traction Significant Barriers to Entry Provide Long-Term Competitive Advantage
2015 COMMERCIAL TRACTION Revenue: $18 MILLION
REGULATORY APPROVALS U.S. and E.U.
MANUFACTURING >9M commercial units produced *
~8M at our China CMO (using multiple lines)
CLINICAL Strong clinical evidence to support
V-Go efficacy and costs savings
REIMBURSEMENT >70% Commercial
> 60% Medicare Part D
INVESTED CAPITAL $375 MILLION
(~$45 MILLION FROM CFBE POST OFFERING)
* Cumulative production quantity as of December 31, 2015
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Key Differentiator: Focus on Large Type 2 Diabetes Market The 4.6 Million Patients Valeritas Targets Represent a $15 Billion Market
Figures approximate. 2012 US Roper Diabetes Patient Market Study provided by GfK Customer Research LLC Chen Y et al, Poster presented at the 2012 ACCP Annual Meeting, October 21 – 24, 2012, Hollywood, Florida, USA
Type 1
Type 2
T O TA L D I A G N O S E D W I T H D I A B E T E S :
~22 million
5-10%
90-95%
5.8 million on insulin
80% not at A1C goal
(4.6 million)
A1c refers to a blood test that correlates with a person’s average blood glucose level over a span of three months.
$15 Billion Annual Opportunity(1)
(1) Based on V-Go® Wholesale Acquisition Price (WAC) of $283.93 per month x 12 months x 4.6 M Type 2 Patients on Insulin not at Goal. WAC price is the gross price sold to wholesalers. The Company’s net price is WAC less fees, discounts and rebates.
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Better Glycemic Control Improves and Extends Lives Significant Adverse Health Effects Influenced by Poor Glycemic Control
Stratton IM et al. BMJ. 2000;321:405-412.
21%
Deaths from Diabetes
14%
Heart Attacks
37%
Microvascular Complications
43%
Peripheral Vascular Disease
Each 1% reduction in mean A1C reduces risk for
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0%
5%
10%
15%
20%
25%
30%
35%
<7% >7% or <8% >8% or <9% >9%
20.4%
26.5%
20.4%
32.7%
Pe
rce
nt
of
Pat
ien
ts
On
Insu
lin
A1C Range
Large Scale Study Validates 80% of Patients on Insulin* are Not at A1C Goal and are Ideal V-Go® Candidates
ClinicoEconomics and Outcomes Research 2013:5 471–479
2011 Database analysis of 27,897 adult patients with diabetes on insulin
20% at Goal
* Insulin: Basal, Basal plus one, Premixed or MDI. Results data from the Health Core Integrated Research Database.
80% of Patients Currently on Insulin Therapy are V-Go Candidates
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Type 2 Diabetics Require Basal and Mealtime Insulin Delivery to Maintain Glycemic Control
(1) Adapted from: Riddle. Diabetes Care. 1990;13:676-686
(2) Holman RR et al. N Engl J Med. 2007; 357 Holman RR et al. N Engl J Med. 2009;361(18):1736-1747
82% of Type 2’s Required Mealtime Insulin to Achieve and Maintain A1C Goal(2)
Pla
sma
Glu
cose
(m
g/d
L)(1
) 200
100
0
6AM 12PM 6PM 12AM
Type 2 Diabetes
6AM
150
250
50
Mealtime / Prandial hyperglycemia
Normal Basal glucose levels
Elevated Basal glucose levels
Time of Day
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Complexity and of Lack of Discretion can Result in Non-Compliance ~75% Patients Prescribed ≥ 3 Shots/Day Do Not Inject Insulin Away From Home
Simplicity Ease-of-use Discretion
V - G o ® S O LV E S U N M E T PAT I E N T N E E D S :
Data from 2011 US Roper Diabetes Patient Market Study provided by GSK Customer Research LLC (Patient’s prescribed 3 or more injections per day)
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12
V-Go® Addresses Key Unmet Needs for Type 2 Market
Complex
Physiologic
Nonphysiologic
Programmable Pump
Intensive Therapy
Basal
Simple
Basal +1 or Premix
V-Go is Simple and Physiologic which makes it Ideal for Type 2 Patients
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* Preset Basal Delivery of Insulin at a Constant Rate
* Bolus Insulin Delivery for Mealtime with 2 units/click V-Go®:
V-Go Device Overview
• Simple filling does not require calculations, measuring or needles
• Prevents accidental needle sticks
EZ FILL
Bolus Chamber
Insulin
Fluid
Fluid
Basal Chamber
Piston
Needle
24 hour Basal rate begins with the push of a button
4.6 mm, 30 gauge
“Floating needle”
On-demand bolus function is
manually activated in 2-step process
Basal rate flow restrictor
Basal rate is spring-driven
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Robust IP with 45 patents issued and 53 pending
14
Statistically Significant Improvements in A1C(1-6)
Can Improve Quality of Life(1)
Lowers Total Daily Insulin Dose (Prescribed / Administered)(1-6)
Demonstrated Cost Reductions(4)
(1) Rosenfeld CR, et al. Endocr Pract. 2012; 18 (5):660-667; (2) Grunberger, G, et al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21-25; Chicago, IL. 985-P; (3) Omer, A. et al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21-25; Chicago, IL. 980-P; (4) Lajara, et al. Poster presented at 2015 AMCP 27th Annual Meeting and Expo, April 2015, San Diego, CA; (5) Lajara, et al. Poster presented at 2015 AACE Annual Scientific & Clinical Congress, May 13-17, 2015, Nashville, TN; and (6) Lajara R, et al. Diabetes Therapy. 2015
Clinical Practice and Clinical Data with V-Go® Support Broad Adoption
1
2
3
4
• Proven improvements in fasting plasma glucose(1,6)
• Discrete and ease to use device enhances compliance and health
• No clinically relevant change in weight (1,2,5)
• Hypoglycemia (low blood sugar) rates similar to baseline(1,4-6)
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Robust Clinical Data Validates V-Go®’s Ability to Deliver Clinically Relevant Reductions in A1C Levels
-3.5
-3
-2.5
-2
-1.5
-1
-0.5
0
-1.0
-1.9
-2.4
-1.2
-1.9
-1.2
-2.3
-3.4
-1.5
Ch
ange
in A
1C
SIMPLE(1) Basal Cohort
Baseline 8.7% 9 Months
UMASS(2)
All Cohorts Baseline 10.7%
3 Months
UPP(3)
All Cohorts Baseline 8.8%
3 Months
EAP(4)
All Cohorts Baseline 9.3%
3 Months
DA(5)
MDI Cohort Baseline 9.4%
~6 Months
DA(7)
T1/LADA Cohort Baseline 9.5%
~7 Months
DA(7)
Insulin Naive Baseline 11.3%
~7 Months
DA(5)
Basal Cohort Baseline 9.6%
~6 Months
DA(6)
Vs. MDI Baseline 9.5%
~7 Months
(1) Grunberger G, et al. Poster presented at: American Association of Clinical Endocrinologists 23rd Annual Scientific and Clinical Congress. May 14-18, 2014; Las Vegas, NV. (2) Omer, A. et al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21-25; Chicago, IL. 980-P. (3) Rosenfeld CR, et al. Endocr Pract. 2012; 18 (5):660-667. (4) Sandberg, M, Martinez, J. Practical Diabetology. 2013;32(3): 6–22. (5) Lajara, et al. Poster presented at 2015 AACE Annual Scientific & Clinical Congress, May 13-17, 2015, Nashville, TN. (6) Lajara R, Davidson JA, Nikkel CC, Morris TL. Endocr Pract. 2016 Feb 1. [Epub ahead of print] (7) Lajara R, et al. Diabetes Therapy. 2015.
N’s =SIMPLE- 59, Endocrine Practice- 56, UMASS- 14, UPP- 23, EAP- 16, DA MDI- 56, DA Basal- 32 DA Insulin Naïve- 24, DA Type 1/LADA- 29. All patients for DA- 204.
Clinically Relevant
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16
Switching to V-Go® Demonstrated Significant Reductions in Total Daily Insulin Dose (TDD) Across Multiple Studies
-45
-35
-25
-15
-5
-18%
-43%(8)
-13%
-22% -20%
-41%
-28% % C
han
ge in
Insu
lin
(1) Grunberger, G, et al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21-25; Chicago, IL. 985-P (all patients – 3 months).
(2) Omer, A. et al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21-25; Chicago, IL. 980-P (percent reduction based on units/kg).
(3) Data on file.
(4) Data on file.
(5) Sink JH et al. Poster presented at Diabetes Technology Meeting. November 6-8, 2014; Bethesda, MD.
(6) Lajara R, et al. Diabetes Therapy. 2015.
(7) Lajara R, Davidson JA, Nikkel CC, Morris TL. Endocr Pract. 2016 Feb 1. [Epub ahead of print] Difference in mean Insulin TDD at end of study MDI 78 U/day vs V-Go 56 U/day.
(8) Figure based on units per kilogram per day.
*Change in basal component of TDD only value available
Diabetes America(6)
99 U TDD Baseline
UPP(3)
56 U TDD
EAP(4)
Basal Dose*
UMASS(2)
119 U TDD
SIMPLE(1) 62 U TDD
Jones Center(5)
76 U TDD
Diabetes America(7)
78 U TDD
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6.0
7.0
8.0
9.0
10.0
11.0
Pre V-Go On V-Go
10.7
8.3*
A1
C (
%)
N=14 Average Duration = 88 days
0
20
40
60
80
100
120
140
Pre V-Go On V-Go
119
64†
Insu
lin T
DD
(u
nit
s)
† P=0.01, *P=0.001
Change
-2.4
Change -55 U
V-Go® Significantly Reduces A1C with Less Insulin Key Benefit to Both Patients and Payors
(1) Based on Insulin TDD absolute units. Omer, A. et al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21-25; Chicago, IL. 980-P. UMASS Study .
Change -2.4
- 55U
Change = 46%(1)
- 2.4
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7.7* 7.6*
8.4*
8.1*
6.5
7.0
7.5
8.0
8.5
9.0
9.5
10.0
Baseline 12 week 27 week
A1
C (
%)
V-Go: N=56 BL A1C- 9.5% BL TDD - 51 U/day, Starting V-Go TDD- 52 U/day, 12 week TDD- 56 U/day, 27 week TDD- 56 U/day
MDI: N=60 BL A1C- 9.4%, BL TDD- 46 U/day, Starting MDI TDD- 64 U/day, 12 week TDD- 75 U/day, 27 week TDD- 78 U/day
Data are mean (SE)
P=0.02
30
40
50
60
70
80
90
51 units 46 units
56
78*
TDD
(U
/day
) at
27
we
eks
Baseline
P<0.0001
V-Go® Demonstrates Significant Improvements In Glycemic Control vs Multiple Daily Injections (MDI)
Lajara R, Davidson JA, Nikkel CC, Morris TL. Endocr Pract. 2016 Feb 1.
Better Control with Less Insulin vs MDI
MDI
V-Go
MDI V-Go
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$0
$50
$100
$150
$200
$250$217.16
$118.84
Insulin costs include both the insulin and associated delivery method. The costs of insulin were normalized by calculating a 30 day insulin requirement based on the total
prescribed daily insulin dose for each insulin and multiplying the monthly dose in units by the unit cost. Only branded antihyperglycemic agents were included in total
therapy costs. All pricing based on published wholesale acquisition costs in 2015 U.S. dollars as of 9/1/2015.
†P-value calculated using the cost inferential per 1% reduction using least squares mean A1C reductions at 27 weeks.
V-Go® is a More Cost-Effective Therapy vs. MDI
Lajara R, Davidson JA, Nikkel CC, Morris TL. Endocr Pract. 2016 Feb 1. [Epub ahead of print]
V-Go Reduced Direct Pharmacy Costs by 45% per 1% Reduction in A1C
† P=0.013
MDI V-Go
Dir
ect
Ph
arm
acy
Co
st P
er M
on
th
Per
1%
red
uct
ion
in A
1C
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20
62
143
54† 67*
Insu
lin T
DD
(U
/day
)
V-Go Baseline
V-Go Baseline
V-Go @6 mos.
V-Go @6 mos.
< 100 U/day at Baseline
≥ 100 U/day at Baseline
V-Go® Appropriate For The Vast Majority of Type 2 Patients Regardless of Prior Prescribed Insulin Dose, V-Go Improved A1C Control
N= 66 patients < 100 U/day at baseline and 38 patients > 100 U/day at baseline
†P<0.05 compared to baseline at 6 months, *P <0.0001 compared to baseline at 6 months
After 6 Months of Using V-Go for Insulin Delivery
Lajara R, Nikkel C. J Diabetes Sci Technol March 2016 10: 476-611, data on file.
Patients on < 100 U
TDD at Baseline
-1.5* -1.7*
Ch
ange
in A
1C
< 100 U/day at Baseline
≥ 100 U/day at Baseline
Baseline 9.3% Baseline 9.5%
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Mean
To
tal D
ail
y D
ose o
f In
su
lin
(U/d
ay)
-3.5
-3
-2.5
-2
-1.5
-1
-0.5
0
-3.0*
-3.4*
LSM
Ch
ange
in A
1C
20
40
60
80
100
120
54**
Insulin Naïve Patients Represent a Significant Market Opportunity for V-Go®
Insulin TDD Utilization Significant A1C
Reduction on V-Go
On V-Go at 27 Weeks 14 Weeks 27 Weeks
Potential for V-Go to be First-Line Insulin Therapy
*p<0.001 compared to baseline based on Least Squares Mean (LSM) change in A1C ** p<0.0001 N= 24, Baseline A1C = 11.3%. Time points represent the mean time elapsed between V-Go initiation and follow-up A1C results for the total population. Lajara R, et al. Diabetes Therapy. 2015.
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Significant New Data Flow Expected in 2016
American Academy of Clinical Endocrinology (May)
American Geriatric Society (May)
Academy of Managed Care Pharmacy (May)
American Diabetes Association Meeting (June)
American Association of Diabetes Educators (Aug)
Additional Manuscripts Published in 2H 2016
5
Posters
2
Posters
5
Posters
1
Poster
2+
1
Oral
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28% 27%
10%
53%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Surv
ey R
esp
on
de
nts
Convenience(1)
Very Convenient
SomewhatConvenient
Note: Patients were surveyed prior to starting V-Go and again ~30 days after being on V-Go.
Patients Rate the Convenience of V-Go® as Superior vs. Previous Therapies
Prior
Therapy V-Go
Therapy
(1) Data on File (Valeritas Customer Care).
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29%
44%
6%
20%
0%
10%
20%
30%
40%
50%
60%
70%
PriorTherapy
V-GoTherapy
Surv
ey
Re
spo
nd
en
ts
Quality of Life(1)
Excellent
GenerallyGood
How do you feel physically & mentally on a typical day?
Note: Patients were surveyed prior to starting V-Go and again ~30 days after being on V-Go.
Patients Rate Their Quality of Life on V-Go® as Superior vs. Previous Therapies
(1) Data on File (Valeritas Customer Care).
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25
V-Go® vs. Traditional Type 1 Pumps & Controllers V-Go has Numerous Advantages for the Type 2 Patient
Simplicity, Cost, Convenience, and QoL Favor V-Go in Type 2 Diabetes
Type 1 Pump & Controller
Reimbursement / Distribution Pharmacy Benefit Medical Benefit via DME
Technology Mechanical / Simple Electronic / Complex / Programmable
Pricing Daily Disposable /
Pay-as-You-Go monthly Durable (2 – 4 year reimbursement
cycle) plus monthly disposables
Training Burden Low (similar to insulin pens) High / Programmability
Competition Insulin Pens
Syringes
Electronic Pump Companies
Valeritas Type 2
• Medtronic & Minimed • J&J Animas • Roche
• Insulet • Tandem
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26
V-Go® is Accessible and More Convenient Through Pharmacies Type 2 Patients Fill Their Insulin and Other Medications at the Pharmacy
• Enhanced patient convenience • Traditional co-pay at pharmacy
~90% Distribution Through Wholesalers
Sold at Pharmacy / Retail Outlets
V-Go for Type 2 Diabetes
V-Go
Durable Medical Equipment
Type 1 Durable Pump
Type 1 Pump Maker
• Requires Medical Necessity • Annual Medical Deductibles • Monthly Medical Co-
insurance
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Pharmacy Benefit Reimbursement Model Cost-effective for both Payors & Patients
V-Go® Therapy
Basal/Bolus Pen Therapy
Neutral Cost to Payors (~$20/day) between Regimens*
*What a Payor Pays (Net of Rebates & Co-pays when V-Go Contracted in Preferred Position)
$31 co-pay
$31 co-pay
$11 co-pay
$31 co-pay
$31 or $53 co-pay1
$73 co-pay
$62 or $84 co-pay(1)
(1) Avg. Nat’l Tier 2 or Tier 3 Co-pay for commercial plans is $31 and $53, respectively, The Kaiser Family Foundation and Health Research & Education Trust Employer Health Benefits 2014 Annual Survey.
Neutral Cost to Patients (+/- $11)
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Established Reimbursement with Pharmacy Benefit
164 MM Pharmacy Lives* Diabetes Prevalence >20 Yrs. old: 12.3%
34 MM Total Lives* Diabetes Prevalence >65 Yrs. old: 18.9%
• Over 90% of V-Go Prescriptions Filled at Retail Pharmacies Since Launch • TRICARE & State Medicaid Cover V-Go Under Pharmacy and/or Medical Benefit
All Access figures as of December 2014. Prevalence data : ADA 2013 Fact Sheet and the CDC Diabetes Report Card 2012. * Commercial Pharmacy Lives: Health Leaders InterStudy 2013: Decision Resources, Medicare Part D Lives: Pathfinder Rx Database 2/1/15.
60%+ Medicare Part D Access 70%+ Commercial Access
< 30% of Lives
Not Covered or Restricted
Access
70%+ of lives
V-Go Covered Under
Insurance
< 40% of Lives Not on
Formulary – Access through
Medical Exception
60%+ of Lives
V-Go Covered Under
Pharmacy Insurance
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Scalable Business Model
Multi-Layered Growth Strategy
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30
Significant Growth Opportunity With Disciplined Sales Force Expansion
Total Coverage of Inside Sales
(~2,800 Targets)
Significant Potential for Future V-Go®
Growth
Figures approximate. 14,000 High Insulin Prescribing MDs Comprising the Top 4 U.S. Deciles generate 40% of All U.S. Annual Insulin TRx’s.
Valeritas is Focused on Generating Share Within our Current Targets
14,000 high prescribers
Current Sales Representative Targeted Prescriber Coverage
1,400 10%
Significant Potential for Future V-Go
Growth
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0.0
100.0
200.0
Jan-14 Jul-14 Dec-14 Jul-15 Dec-15
Revamped Sales & Marketing Strategy: A More Effective, Higher Focused & Less Capital Intensive Model
TRx
/ M
on
th /
Re
p
• Resources diluted across all territories
• Greater capital requirements
Top performing territories
Low performing territories
Cust. Care
DTP Pilots
Promo Services
Old Sales Model New Sales & Marketing Model
0.0
125.0
250.0
Jan-15 Jul-15 Dec-15 Jun-16 Dec-16
• Greater & strengthened support resources focused on prioritized higher volume territories
• Less capital intensive model
Cust. Care
Promo Services
3rd Party Peer to Peer
sales
DTP
TRx
/ M
on
th /
Re
p
Inside Sales
Top performing territories
Low performing territories
Vacated territories
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32
Flex circuit
Battery
Antenna
ASIC V-Go cover
V-Go LinkTM(2) V-Go® V-Go Pre-fill(2)
• Prefilled Insulin cartridges to eliminate filling step
• No EZ Fill refrigeration
• Lower number of co-pays(1)
• Enables participation in insulin market
• Expands target population
• Extends patent life
(1) Assumes V-Go’s and insulin cartridges packaged in a single box under a single NDC thereby potentially reducing the number of prescriptions and the number of co-pays required per patient. (2) Product currently under development.
• Provides connectivity to devices
• smart phones / glucose meters
• Provides for one-way communication from V-Go
• Increases patient adherence
• Could be used as diagnostic tool to make treatment adjustments
• Current product
• Filled by patient using V-Go EZ-FillTM
• Commercially available in U.S.
• Approved in E.U.
Next-Generation V-Go® Products Provide Path to the Broader Diabetes & Insulin Market
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33
Extensive Patient Experience With Proven Quality V-Go® product quality validated with ~ 7 million devices used over the past 3 years
Source: Symphony Health Solutions (Retail and Mail Order).
V-Go adherence & persistency better than most Type 2 regimens (injections or pills)
6 Million
3 Million
2 Million
1 Million
5 Million
4 Million
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$0.6
$6.2
$13.5
$18.1
2012 2013 2014 2015
Valeritas: Financial Profile Poised for Growth and Profitability Ahead of Industry Peers
Gross Margins
Revenue ($ in millions)
• COGS highly dependent on Volume
• 50% Gross Margins can be achieved with $60M annual run rate
• 80% Gross Margins achievable with Global Commercialization
• Insulet required $58M annual run rate to achieve 20% GM (Q2’09)
2013
Negative
2015
+21%
Annual Revenue (March 2012 – December 2015)
34%
118%
NM
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Significantly De-Risked, Commercially Marketed Product with Substantial Growth Opportunities
Regulatory • 510(k) – US • CE Marking Certification –
Europe
Clinical Evidence • Strong Efficacy data • Costs effective data
Reimbursement • >70% commercial access • >60% Medicare D access • TRICARE
Prescriber & Patient Acceptance
• Strong TRx uptake per rep
Manufacturing • >9M units produced to date • ~8M Units from China CMO
Advancing Type 2 Basal / Bolus Insulin Delivery
Growth Opportunities / Catalysts
▫ U.S.
– Focus on most productive sales territories
• 2017 Expansion of sales force based on new focused model and managed care “wins”
– Focused promotion in prioritized markets
– Targeted direct-to-patient marketing
– Continued reimbursement opportunities
▫ International Market Licensing
▫ Next Generation V-Go® Pre-fill
▫ Platform Expansion
– Other therapeutics (e.g. Pain Therapy)
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