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December 2015
Digital Healthcare / Healthcare Technology
Medidata Solutions (MDSO) Primer Book
Thesis: Our investment hypothesis on MDSO holds that the company remains
poised to be a long-term winner as the development of biopharmaceutical
products, specifically outsourced solutions, becomes more technologically
driven over time.
Steve Rubis (214) 706 - 9451 rubiss@stifel.com
Stifel does and seeks to do business with companies covered in its research reports. As a result,
investors should be aware that the firm may have a conflict of interest that could affect the objectivity of
this report. Investors should consider this report as only a single factor in making their investment
decision.
All relevant disclosures and certifications appear on pages 21 – 24 of this report.
Medidata Solutions Primer Book
1
MDSO Investment Hypothesis
The Evolving Biopharma Business Model
Three Existential Questions for MDSO Investors
Cross Over Debates
Key Risks
The Electronic Data Capture (EDC) Market Opportunity
The FDA Regulatory Environment
The Evolving Productization Landscape
The Point to Platform Shift Value Proposition
MDSO mHealth Clinical Trial
Contract Research Organizations (CROs) and MDSO Utilization
Platform Customer Analysis
Customer Analysis
Company Statistics
Clinical Trial Statistics
Competition
M&A Opportunities
Model
Table of Contents
Medidata Solutions Primer Book
2
MDSO Investment Thesis
Sources: Stifel Research
The MDSO Investment Hypothesis
Our investment hypothesis on MDSO holds that the company remains poised to be a long-term
winner as the development of biopharmaceutical products, specifically outsourced solutions,
becomes more technologically driven over time.
We believe that as the FDA drives clinical trials toward complete digitization, prescription drug
pricing pressures require new ways of creating products, and precision / personalized medicine
leads to more complex therapies that outsourcing will focus less on people and more on
technology.
The Key Drivers of Our Investment Hypothesis, Include:
The FDA Regulatory Environment
• Complete Digitization of Clinical Trial Data Submissions
A Strong EDC Market Opportunity
• FDA Digitization Makes Pen and Paper Obsolete
Evolving Biopharma Productization
• Pricing Pressure Disrupts Product Development
Evolution / Adoption of mHealth / Wearables
• Pricing Issues Drive Focus on New Opportunities
Platform Value Proposition
• FDA, Pricing Pressure, and Evolving Technologies Combine to Create a Strong and Sticky
Value Proposition
Medidata Solutions Primer Book
3
The Evolving Biopharma Business Model
Old Clinical Trial and Product Paradigm
Clinical
Trials
The major revenue growth lever of the old clinical trial paradigm revolved around price
What Types of Data?
• Adherence
• Comparative Efficacy
• Real World Efficacy
• Utilization
Drivers of the NewParadigm
• $2.7T in Healthcare costs are driving cost rationalization
• $2.6B to develop a drug is unsustainable LT
• CMS' push to outcomes based reimbursement
The Era of Biopharma Productization: We believe MDSO must illustrate new capabilities and a strong value proposition which revolves
around the data requirements of an outcomes based reimbursement environment.
MDSO and the Era of BiopharmaProductization
Statistical Significance Product Revenue =
Price X Quantity
New Clinical Trial and Product Paradigm
Clinical
Trials
Statistical
Significance
+
Verification
Product
Revenue =
Price X Quantity + DATA
Price no longer represents the magical hammer of revenue growth, as biopharma companies
must continuously prove their products worth in order to maintain pricing power.
Key Indicators of Changing Environment
• Focus on mHealth - Roche, NVS, GSK, BIIB, et al.
• Rave + TSDV+ mHealth, but what else?
• Precision Medicine
Sources: Stifel Research
Medidata Solutions Primer Book
4
We Believe MDSO Faces Three Existential Questions
Question 1: Is MDSO Well Positioned for Business Model Disruption in Biopharma Stemming
from Pricing Pressures?
Our View: We believe MDSO may be well positioned to benefit from looming business model
disruption stemming from outcomes driven pricing and reimbursement. Biopharma sponsors need
new and innovative ways to ensure product development meets outcomes requirements e.g.,
adherence, comparative efficacy, real world efficacy, and utilization. We believe the fully unified,
cloud-based platform of MDSO will help biopharma sponsors navigate the challenging environment.
Question 2: What Capabilities Does MDSO Offer to Biopharma Sponsor Clients to Help
Navigate Looming Business Model Disruption Due to Pricing Concerns.
Our View: We believe MDSO needs to illustrate the value proposition associated with new and
current capabilities that will help biopharma sponsors navigate business model disruption stemming
from outcomes based reimbursement and pricing. Currently, MDSO provides quite a bit of
benchmarking and analytical insight around trial site performance. In our view, cloud-based
platforms with robust intelligence regarding a certain portion of the platform are typically able to
replicate such intelligence around additional portions of the platform.
Question 3: Has the MDSO platform value proposition strengthened in FY15 due to new new
products (TSDV and Patient Cloud)?
Our View: We believe the development of Targeted Source Data Verification and the Patient Cloud
(mHealth) provide the strongest platform value proposition in recent memory. We believe the
combination of Rave, TSDV, and Patient Cloud seems well positioned for the significant focus on
mHealth and more efficient clinical trials among clients. We believe the FDA clinical trial data
submission backdrop provides a further tailwind.
Three Existential Questions for MDSO Investors
Sources: Stifel Research
Medidata Solutions Primer Book
5
Debate 1: Will FDA’s Digitization of Clinical Trial Data Submissions Positively Impact MDSO?
Our View: We believe the FDA’s focus on completely digitizing the clinical trial data submission process
provides a significant tailwind that will help push many sponsors toward platform adoption, especially in light
of the strong value proposition linking Rave, TSDV, and Patient Cloud.
Debate 2: Does the FDA Fully Support the Use of mHealth in Clinical Trials?
Our View: We believe the FDA is quite interested in the utilization of mHealth in clincial trials. We believe
the recent symposium hosted by MDSO and the New York Academy of Sciences illustrated this view. The
industry realizes mHealth may provide a tool to capture more holistic data. Additionally, mHealth remains
important given the number of patient driven clinical trial end points.
Debate 3: Is the MDSO Clinical Cloud Too Expensive?
Our View: We recognize that the MDSO clinical cloud may be expensive to biopharma sponsors and CROs
operating at the lower end of the market. Nevertheless, we believe strong utilization among top 50 pharma,
additional platform deals, and continued rescue activity suggest the platform exhibits strong value despite
apparent price concerns.
Debate 4: Can the Market Continue to Support Mid-Teens EDC (Rave) Growth?
Our Take: We believe the FDA’s push to completely digitized clinical trial data submissions provides a
tailwind to EDC growth. We provide more detail on the “Electronic Data Capture (EDC) Market Opportunity”
slide below.
Debate 5: Is MDSO’s TAM More Limited Than Investors Believe?
Our Take: We believe MDSO’s TAM is likely between $4B and $5B, whereas the company’s long-term TAM
may be $8B to $10B or more. We believe the company established the NT and LT TAM opportunities at its
2013 Investor Day meeting. Based on competitor commentary, we believe MDSO’s TAM estimate for
mHealth, roughly $1B, may be conservative.
Debate 6: Are Negative Industry Participant Comments Believable?
Our Take: We believe investors should be skeptical of negative industry participant comments regarding
MDSO. In our view, the negative commentary put forth by shorts is often biased by CROs or entities that
compete with MDSO.
MDSO Cross Over Debates
Sources: Stifel Research
Medidata Solutions Primer Book
6
MDSO Key Risks
Sources: Stifel Research
The Key Risks to Our MDSO Investment Hypothesis
Long-Term Growth Rate Trajectory
• A key concern among many investors revolves around MDSO’s long-term growth rate
• Historically, management pointed to 20% y/y to 25% y/y revenue growth
• Investors are concerned management may revise the growth range lower e.g., 17% y/y to
23% y/y
Professional Services Revenues
• The primary source of recent fundamental underperformance stems from professional
services revenues
• Professional Services revenues are less predictable due to longer cycle times at CROs
Biopharma R&D Funding
• A major deceleration or decline in R&D funding across biopharma sponsors would lead to
fundamental performance pressure at MDSO
Clinical Trial Starts / Activity
• We believe clinical trial starts are a key indicator for MDSO
• Clinical trial starts have increased each year since the mid-2000s
• 2015 may mark the first year clinical trial starts decelerate
Lack of Value-Add Product Innovation
• A primary differentiating factor around the MDSO story revolves around product innovation
• MDSO became an industry leader by innovating more than previous market leaders
• The company must continue to evolve the platform forward to meet the needs of the new
pricing environment, as well as more complex products (precision medicine)
Medidata Solutions Primer Book
7
The Electronic Data Capture (EDC) Market Opportunity
Sources: Stifel Research
Key Controversy: MDSO bears continuously point to the belief that the EDC market is fully penetrated and
cannot provide continued growth to MDSO. We believe the EDC market opportunity remains attractive and
can continue to support growth.
What Is Electronic Data Capture (EDC)?
• EDC represents a computerized system that facilitates the collection of clinical trial data in an electronic
format.
• EDC can increase data accuracy and decrease time to collect data associated with clinical studies
• EDC systems are beneficial for late-phase (phase III to IV) studies
Our Key Assumptions Regarding the EDC Market
• We believe by mid-2017 all new clinical trials will be electronic
• Today, approximately 70% of clinical trials are digitized
• We believe MDSO represents between 40% and 50% of these digitized trials
Our View of the EDC Market Opportunity Today
The EDC Market
We Believe MDSO can
1. Take Share from
Competitors
and
2. Take Share from Undigitized
Trials
Undigitized Trials = 70%
MDSO Represents Between 40%
and 50% of digital trials
Digitized Trials = 70%
Competitors Represent Between
20% and 30% of digital trials
All Trials Must Be Digital By
Mid-2017
Medidata Solutions Primer Book
8
The FDA Regulatory Environment
Sources: Stifel Research
The Regulatory Environment
FDA and digitization of clinical trial data submissions
• Two major deadlines are driving the digitization of clinical trial data submissions
• 12/17/16 – required data standards
• 5/5/17 – eCTD
• Digital data submissions continue to increase: 55% in FY13, 64% in FY14, and 71% FY15 (as of Sept.)
FDA Comments on mHealth from NYAS conference
• Mobile technologies have enormous potential to make new physiological measurements
• Remote transmission of data may change the way trials are done
• There are no regulatory restrictions to use of these technologies
• The questions to be answered relate to meaningful clinical effects and reliability of the data
FDA pilot for EHR to EDC connectivity
• The FDA continues to evaluate efforts to seamlessly link EDC to EHRs
FDA May Look to Do More with Digital Trials
• Think Efforts Around Fraud and Waste
32
17
5
16
48
24
54
84
Endpoints in NDAs 2007 - 2015 (n = 280)
127
24
8
55 63 64
81
189
Endpoints in Studies 2007 - 2015 (n = 611)
Medidata Solutions Primer Book
9
The Evolving Productization Landscape and the Impact of Pricing
What Seems to Be Driving the New Clinical Trials Paradigm?
Complex Therapeutic Environment
• Product development collaboration
• Precision medicine
• The need for an Enterprise Resource Planning (ERP) for clinical trials
• Several companies (INC Research, Merck, and Novartis, et al.) see technological
innovation associated with clinical trials coming from non-CROs
• Pricing Pressures
• Hepatitis C – Viekira Pak versus Harvoni
• PCSK9 inhibitor drugs – Amgen and Regeneron
• Indication specific pricing
• Greater emphasis on risk sharing monetization structures
What Types of Data?
• Adherence
• Comparative Efficacy
• Real World Efficacy
• Utilization
Drivers of the New Paradigm
• $2.7T in Healthcare costs are driving cost rationalization
• $2.6B to develop a drug is unsustainable LT
• CMS' push to outcomes based reimbursement
New Clinical Trial and Product Paradigm
Clinical
Trials
Statistical
Significance
+
Verification
Product
Revenue =
Price X Quantity + DATA
Price no longer represents the magical hammer of revenue growth, as biopharma
companies must continuously prove their products worth in order to maintain pricing
power.
Key Indicators of Changing Environment
• Focus on mHealth - Roche, NVS, GSK, BIIB, et al.
• Rave + TSDV+ mHealth, but what else?
• Precision Medicine
Sources: Stifel Research
Medidata Solutions Primer Book
10
MDSO and the Point to Platform Shift Value Proposition
The MDSO Point-to-PlatformShift
• The Shift Entails a Long Cycle; One Year Plus
• We See the Possibilityfor Three Platform Deals in FY15
Clinical Trials MDSO Modules
Initial Agreement
First Expansion:
More Trials
Second Expansion:
More Products
Third Expansion:
All Clinical Trials
Fourth Expansion:
Enterprise Customer
Final Expansion:
Platform Customer
Single Trial Single Product (LikelyMedidata Rave)
Single Trial Works;
Expands to Several Trials Still Single Product (LikelyMedidata Rave)
Running SeveralTrials on MDSO
Multiple Products; LikelyRave + Another
Module (Coder, Gateway, Balance)
Client Now Runs All Clinical Trial
Volume on MDSO Platform
Multiple Products; LikelyRave + Another
Module (Coder, Gateway, Balance)
Client Runs Most, If Not All Trial
Volume on MDSO
Client Utilizes Core Products (4 Total):
Rave + Gateway+ Coder + Balance
Client Runs All Trial Volume on
MDSO
Client Utilizes All MDSO Modules:
Rave + Gateway+ Coder + Balance +
TSDV + Patient Cloud
The Evolving Client / MDSO Relationship
Initially, An Interesting, But Not Must Have Solution
• Competitors MayDo Some Modules Better
Over Time, Evolves Into a Must Have Solution
• Drivers - Pricing, Complexity, Efficiency
Sources: Stifel Research
Medidata Solutions Primer Book
11
MDSO mHealth Clinical Trial
Analyzing MDSO’s MOVE-2014 Clinical Trial – mhealthclinicaltrials.com
MDSO sponsored a study to illustrate the value of mHealth technology within clinical trials
• Equipped patients with a Fitbit Flex and iPhone
• Provided a mobile app to capture diary and quality of life data (Patient Cloud)
• Over eight weeks, MDSO tracked the effect of sensors, wearables, and apps on health
outcomes in overweight people with Type 2 Diabetes
The MOVE-2014 Results: MDSO illustrated that studies can successfully instrument patients in
a clinical trial
Data Quality
• Higher Visibility of Data Led to Higher Data Quality - Outliers may be a function of device
quality issues
• Calculated sleep efficiency and illustrated implausibility of an outlier
• Verified an outlier of 35,000 steps in a single day
Patient Compliance
• Compliance is an Important Data Quality Check – High Compliance Associated with Wearing
a Tracker; Sleep Mode Was a Problem
• Subjects wore devices over 90% of the time
• Subjects failed to put devices in sleep mode consistently
• Subjects were mostly compliant around completing questionnaires via a mobile app
Observations
• mHealth Data Yields Many Possible Clinical Insights – Data Correlations Exist
• Pain vs. BMI: highest levels of pain resulted in lowest BMI reduction
• Analyzed a subject cluster who achieved both blood glucose and BMI reduction to
understand phenotypic (behavioral) characteristics on results
Sources: Company documents and mhealthclinicaltrials.com
Medidata Solutions Primer Book
12
CROs Continue to Utilize More of MDSO
• MDSO product density among CRO partners continues to increase over time
• We estimate Inc Research, Theorem Clinical, and PRA International are MDSO platform customers
• While CRO adoption / utilization of Rave remains strong, CROs are increasing adoption of Coder,
Balance, TSDV, and the Patient Cloud
Contract Research Organizations (CROs) and MDSO Utilization
1
1
1
4
7
9
20
7
10 Products
9 Products
8 Products
7 Products
6 Products
5 Products
4 Products
3 Products
2 Products
1 Product
0 Products
CRO Product Density of MDSO Modules
43
5
16
1
3
11
2
7 7
Medidata
Rave
Medidata
Rave Safety
Gateway
Medidata
Coder
Medidata
Designer
Medidata
Grants
Manager
Medidate
Balance
Medidata
CTMS
Medidata
TSDV
Medidata
Patient
Cloud
CROs Using Medidata Producs (n=43)
From June to October, CRO utilization of Rave,
Coder, Grants Manager, Balance, and Patient
Cloud increased.
The MDSO CRO Opportunities
1. CRO customers seem to be adopting more of the
MDSO cloud.
2. MDSO enterprise / platform CROS seem to be
increasing
We estimate MDSO has roughly two to six enterprise
clients and roughly one to three platform CRO clients.
Sources: Stifel Research
Medidata Solutions Primer Book
13
MDSO Platform Customer Analysis
Sources: Stifel Research
Biopharma Sponsors Contract Research Organizations (CROs)
Johnson and Johnson
Alcon (subsidiary of Novartis)
GlaxoSmithKline
Platform Deals Delayed to 4Q15, Our Guess:
Astellas - INC Research Cust.
Otsuka - INC Research Cust.
INC Research
Theorem Clinical
PRA International
Platform deals have been a major focus since 2012. Deals have been slow to materialize due to
long sales and transformation cycles at sponsor and CRO clients. In our view, the platform value
proposition seems much stronger with the inclusion of Targeted Source Data Verification (TSDV)
and the Patient Cloud (mHealth). We think the regulatory and price environment now lends
clinical trial outsourcing to technology more than ever.
An Overviewof Key MDSO Platform Customers
Platform Value Proposition =
Rave + TSDV + Patient Cloud +
Significant Interest in mHealth (Roche, Novartis, GSK, Biogen, et al.) +
FDA clinical trial data submission digitization efforts
Medidata Solutions Primer Book
14
MDSO Customer Analysis
Penetration Stats
• 5 of top 50,
roughly 10%
• Top 50
penetration is
66%
• Top 50 Direct is
54% penetration
• Top 50 via CRO
is 18%
penetration
Rank Company Direct User CRO Relationship At Least One Relationship
1 Novartis YES YES
2 Pfizer
3 Roche YES YES YES
4 Sanofi YES YES YES
5 Merck
6 Johnson & Johnson YES YES
7 GlaxoSmithKline YES YES
8 AstraZeneca YES YES
9 Gilead Sciences YES YES
10 AbbVie YES YES
11 Amgen YES YES
12 TEVA YES YES
13 Bayer YES YES
14 Eli Lilly YES YES YES
15 Novo Nordisk
16 Boehringer Ingelheim
17 Takeda YES YES
18 Bristol-Myers Squibb YES YES
19 Actavis
20 Astellas Pharma YES YES
21 Baxter International YES YES
22 Biogen YES YES
23 Merck KgA
24 Mylan YES YES
25 Daiichi Sankyo YES YES
26 Celgene YES YES
27 Otsuka YES YES
28 Allergan YES YES
29 Les Laboratories Servier
30 Shire YES YES
31 Abbott Laboratories YES YES
32 Sun Pharmaceutical
33 Valeant
34 CSL
35 Eisai
36 UCB
37 Fresenius
38 Chugai Pharmaceutical YES YES
39 Menarini YES YES
40 Grifols
41 Aspen Pharmacare YES YES
42 Hospira
43 Sumitomo Dainippon YES YES
44 Mitsubishi Tanabe
45 STADA
46 Mallinckrodt YES YES
47 Endo International YES YES
48 Alexion YES YES
49 Lundbeck YES YES
50 Kyowa Hakko Kirin YES YES
Sources: Company documents and Stifel Research
Medidata Solutions Primer Book
261 275 287
316 333 350 358 363 379
397
420
437
462
486
516
539 572
27.6%
27.3%
24.7%
14.9%
13.8% 13.4%
17.3%
20.4%
21.9% 22.4% 22.9% 23.3% 23.8%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
0
100
200
300
400
500
600
700
3Q11 4Q11 1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 3Q13 4Q13 1Q14 2Q14 3Q14 4Q14 1Q15 2Q15 3Q15
ClientGrowth(Y/Y)
Clients
Medidata Solutions Client Trends
Clients Client Growth (Y/Y)
92
104
120
133
147
163
178
195
218
236
259
282
304
329
372
32%
33%
36%
38%
41%
45%
47%
49%
52%
54% 56% 58% 59% 61%
65%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
0
50
100
150
200
250
300
350
400
1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 3Q13 4Q13 1Q14 2Q14 3Q14 4Q14 1Q15 2Q15 3Q15
CustomersPurchasingMultiple
Productsasa%ofTotalCustomers
Clients
Clients Are Adopting Multiple Solutions
Multi-Product Customers Multi-Product Penetration
15
MDSO Company Statistics
Sources: Company documents and Stifel Research
Medidata Solutions Primer Book
16
Clinical Trial Statistics
Changes in Protocol Complexity 2002 2012 Change
Number of End Points 7 13 86%
Number of Protocol Procedures 106 167 58%
Number of Eligibility Criteria 31 50 61%
Number of Countries 11 34 209%
Number of Investigative Sites 124 196 58%
Number of Patients Randomized 729 597 -18%
Number of Data Points Collected per Patienta
500,000 929,203 86%
115 120
413
460
129 143
714
780
Protocol Ready
to FPFV
Protocol Ready
to Drug Available
Protocol Ready
to LPLV
Protocol Ready
to Data Lock
MedianDaysElapsed
Simple Complex
2.4
2
2.6
3.6
2.3
6.9
5.6
6.8
8.5 8.3
Overall Phase I Phase II Phase III Phase IIIb/IV
Amendments and ChangesPer Protocol
Amendments Changes Per Amendment
43%
52%
37%
30%
38%
Overall Phase I Phase II Phase III Phase IIIb/IV
Protocol and Amendment Timing
Amendments
Sources: Company documents and Stifel Research
Medidata Solutions Primer Book
17
Pen and Paper / Homegrown Systems
• Many companies use proprietary legacy systems and rely on cobbling together disparate systems
that are not often easily connected
Contract Research Organizations (CROs)
• Both MDSO competitor and MDSO client
• CROs face the prospect of losing share to technology based solutions
Oracle / Phase Forward
• Prior market leader (Phase Forward) in Electronic Data Capture (EDC)
• Largest competitor next to MDSO
• Strength lies in ability to tie clinical trials seamlessly to financial systems
Parexel Informatics (Perceptive Informatics)
• Data and applications for clinical trials
• Primary products include: EDC, CTMS, ePRO, RTSM, and medical imaging
BioClinica
• eClinical solutions provider
• Core products include: EDC, CTMS, RTSM, RBM, and Optimization
Medrio
• Cloud-based eClinical solutions provider focused on the Phase I trial market
Datatrak
• An early player in EDC whose product suite now primarily focuses on EDC plus CTMS, Trial Design,
Medical Coding, Randomization & Trial Supply Management, Safety, and Training
Omnicomm
• eClinical solutions provider focused on Phase I trials
Veeva Systems
• Veeva Vault – eTMF and expansion into study start-up and Vault RIM
Competition
Sources: Stifel Research
Medidata Solutions Primer Book
18
M&A Opportunities
We believe innovation in clinical trials represents a major area of investment focus for venture capital.
Additionally, biopharma sponsor companies continue to talk about the need to completely re-configure
product development. While we see MDSO as a leading innovator, we believe they will likely look to
acquire technology, as well. As of September 30, 2015, MDSO held $492.9 million in cash and cash
equivalents.
Interesting M&A Opportunities for MDSO:
We have no knowledge of any M&A negotiations or discussions between Medidata Solutions and any
of the identified potential parties. In addition, the probabilities outlined below are based on our
estimates
CTMS (Clinical Trial Management System): While MDSO attempted to improve its offering in CTMS with a
tuck in acquisition in 2011 (Clinical Force), we see CTMS as the Achillies heel of the platform. We have even
heard of a company (Abbvie) look to Salesforce for CTMS; Salesforce does not provide a specific CTMS
solution.
goBalto: Provider of next generation solutions that facilitate a simpler and more efficient study start-up
process. Essentially a tool that optimizes electronic Trial Master File (eTMF) and Clinical Trial Management
Solutions (CTMS) functions.
Medrio: eClinical software vendor primarily focused on the EDC market for phase I trials. Medrio might
represent a tuck-in acquisition that would help MDSO in the phase I trial market. The company has facilitated
1,000+ studies across 500 clients since 2005.
ePatientFinder: Software provider that helps healthcare providers learn about and direct relevant patients to
clinical trials. The solution utilizes algorithms to match physicians with treatments relevant to patients based on
EHR data.
Virtual Clinical Trials: The focus on leveraging technology to bring clinical trial research to the patient’s home
and local health system.
Sources: Company documents and Stifel Research
Medidata Solutions Primer Book
19
MDSO Model
Sources: Company documents and Stifel Research
Medidata Solutions, Inc. (MDSO)
Statement of Income
($ in 000s, except per share) FY FYE FYE FYE 1Q14 2Q14 3Q14 4Q14 1Q15 2Q15 3Q15 4Q15 E
FY Ends Dec 2014 2015 2016 2017 Mar-14 Jun-14 Sep-14 Dec-14 Mar-15 Jun-15 Sep-15 Dec-15
Subscription 280,041 343,954 415,496 496,518 63,811 68,947 71,547 75,736 78,749 83,929 88,878 92,398
Professional Services 55,030 56,096 59,462 63,624 12,829 14,276 14,449 13,476 13,691 14,155 14,235 14,015
TOTAL REVENUE 335,071 400,050 474,958 560,142 76,640 83,223 85,996 89,212 92,440 98,084 103,113 106,413
Subscription 45,576 49,252 61,078 64,350 11,086 11,221 11,413 11,856 11,473 12,354 12,489 12,936
Professional Services 39,344 41,725 44,002 46,285 9,713 9,753 9,582 10,296 10,703 10,557 10,304 10,161
Cost of revenues (excludes D&A) 84,920 90,977 105,080 110,636 20,799 20,974 20,995 22,152 22,176 22,911 22,793 23,097
Gross Profit 250,151 309,073 369,878 449,507 55,841 62,249 65,001 67,060 70,264 75,173 80,320 83,316
Research and Development 71,757 93,842 112,860 134,434 17,789 17,311 17,677 18,980 21,911 22,519 24,192 25,220
Sales and Marketing 83,435 102,845 119,515 137,235 20,732 20,425 21,004 21,274 24,318 25,724 25,881 26,922
General and Administrative 69,111 81,873 90,242 109,228 17,046 17,373 17,865 16,827 20,569 21,943 19,143 20,218
Other 5,784 0 0 0 0 0 4,880 904 0 0 0 -
Operating Income 20,064 30,513 47,262 68,610 274 7,140 3,575 9,075 3,466 4,987 11,104 10,956
Interest Expense (15,368) (15,817) (15,297) (15,297) (3,781) (3,827) (3,849) (3,911) (3,958) (3,997) (4,038) (3,824)
Interest Income 1,814 2,624 2,956 2,956 395 420 465 534 534 612 739 739
Other Income, Net 4 (22) 217 60 34 (28) 0 (2) (34) (34) 3 43
Pretax income 6,514 17,297 35,137 56,328 (3,078) 3,705 191 5,696 8 1,568 7,808 7,913
Income Taxes 422 6,202 14,072 22,559 (1,263) 1,409 30 246 (149) 55 3,127 3,169
Tax Rate 6.5% 36% 40.0% 40.0% 41.0% 38.0% 15.7% 4.3% NM 3.5% 40.0% 40.0%
Net Income, pro forma, cont ops 6,092 11,095 21,065 33,770 (1,815) 2,296 161 5,450 157 1,513 4,681 4,744
Basic EPS, pro forma, cont ops 0.12$ 0.21$ 0.39$ 0.61$ (0.03)$ 0.04$ 0.00$ 0.10$ 0.00$ 0.03$ 0.09$ 0.09$
Diluted EPS, pro forma, cont ops 0.11$ 0.20$ 0.37$ 0.59$ (0.03)$ 0.04$ 0.00$ 0.10$ 0.00$ 0.03$ 0.08$ 0.08$
Shares outstanding
Basic 52,558 53,720 54,318 54,933 52,109 52,457 52,772 52,895 53,257 53,647 53,933 54,043
Diluted 54,338 56,333 57,072 57,687 52,109 54,828 55,069 55,347 55,658 56,191 56,687 56,797
Cash EPS (before stock comp) 0.74$ 0.87$ 1.13$ 1.43$ 0.11$ 0.17$ 0.20$ 0.25$ 0.17$ 0.22$ 0.25$ 0.24$
Adjusted EBITDA 74,236 92,038 115,957 144,846 12,508 18,379 21,200 22,149 17,689 21,760 25,957 26,632
Percentage of Revenues
Gross profit, pro forma 74.7% 77.3% 77.9% 80.2% 72.9% 74.8% 75.6% 75.2% 76.0% 76.6% 77.9% 78.3%
Research and Development 21.4% 23.5% 23.8% 24.0% 23.2% 20.8% 20.6% 21.3% 23.7% 23.0% 23.5% 23.7%
Sales and Marketing 24.9% 25.7% 25.2% 24.5% 27.1% 24.5% 24.4% 23.8% 26.3% 26.2% 25.1% 25.3%
General and Administrative 20.6% 20.5% 19.0% 19.5% 22.2% 20.9% 20.8% 18.9% 22.3% 22.4% 18.6% 19.0%
Operating Income 6.0% 7.6% 10.0% 12.2% 0.4% 8.6% 4.2% 10.2% 3.7% 5.1% 10.8% 10.3%
Adjusted EBITDA 22.2% 23.0% 24.4% 25.9% 16.3% 22.1% 24.7% 24.8% 19.1% 22.2% 25.2% 25.0%
Year / Year Growth Rate
Net Sales 21.0% 19.4% 18.7% 17.9% 21.2% 22.3% 21.2% 19.6% 20.6% 17.9% 19.9% 19.3%
Subscription 22.9% 22.8% 20.8% 19.5% 26.0% 22.4% 23.5% 20.3% 23.4% 21.7% 24.2% 22.0%
Professional Services 12.5% 1.9% 6.0% 7.0% 1.8% 21.8% 11.1% 16.2% 6.7% -0.8% -1.5% 4.0%
Adjusted EBITDA 10.5% 24.0% 26.0% 24.9% -12.0% 5.1% 16.4% 28.1% 41.4% 18.4% 22.4% 20.2%
Operating Income -16.0% 52.1% 54.9% 45.2% -96.1% -19.2% -62.3% 1165.0% -30.2% 210.6% 20.7%
Pretax Income -64.6% 165.5% 103.1% 60.3% -142.1% -58.2% -97.4% -57.7% 3988.0% 38.9%
Net Income -63.4% 82.1% 89.9% 60.3% -131.8% -55.0% -96.9% 836.4% -34.1% 2807.5% -13.0%
Diluted EPS -64.5% 81.8% 85.0% 59.5% -127.3% -60.0% -100.0% 900.0% -25.0% -20.0%
Guidance from Company
Subscription (Revised as of 3Q15) $336.0M to $345.0M $84.4M to $93.4M
Professional Services Revenues (Revised as of 3Q15) $56.0M to $57.0M $13.9M to $14.9M
Total Revenue (Revised as of 3Q15) $392.0M to $402.0M $98.4M to $108.4M
GAAP Operating Income (Revised as of 3Q15) $28.0M to $31.0M $8.4M to $9.9M
Adjusted EBITDA $90.0M to $96.0M $24.6M to $27.6M
Adjusted Non-GAAP Net Income $47.0M to $50.5M
Source: Company Reports and Stifel estimates
Steve Rubis - (214) 706 - 9451
Updated: October 27, 2015
Medidata Solutions Primer Book
20
Bibliography of Pertinent MDSO Notes
A List of What We Believe to Be Our Most Relevant Research on MDSO
10/27/15 – MDSO: 3Q15 Better Than First Thought; Long-Term Thesis Intact; Attractive Entry Point
10/23/15 – Digital Health Check-Up: Why We Think the World May Be Changing
10/14/15 – Digital Health Check-Up: Mobile Health Conference Helps Frame MDSO Platform Value
Proposition
10/12/15 - MDSO: Does It Make Sense to Scale in Current Environment? We Say Yes; Maintain Buy
9/30/15 - MDSO: What We Learned at SCDM 2015 About EDC and Digitization
9/30/15 – Digital Health Check-Up: Thoughts from SCDM and the Digitization of Clinical Trials
9/25/15 – Digital Health Check-Up: Connect 2015 and the Internet of Medical Things (IoMT)
9/21/15 - MDSO: Fundamentals Unchanged; EDC Remains Sticky; mHealth Continues to Evolve; Buy
9/14/15 – Digital Health Check-Up: The Digital Health Investment Roadmap for 2H15 and Beyond
8/4/15 – MDSO: CRO 2Q15 Commentary Suggests Strong 2H15 for MDSO; Reiterate Buy
4/17/15 – MDSO: 1Q15 Preview; the Era of Biopharma Productization; CRO Product Density; Buy
2/1/15 – MDSO: Revisiting the Impact of NVS / QCOM Life Announcements; 4Q14 Preview, Maintain Buy
6/16/14 – Initiating Coverage of Medidata Solutions with a Buy Rating; Drug Trial Cloud
Medidata Solutions Primer Book
21
Disclosures
Important Disclosures and Certifications
I, Steven A. Rubis, certify that the views expressed in this research report accurately reflect my personal
views about the subject securities or issuers; and I, Steven A. Rubis, certify that no part of my
compensation was, is, or will be directly or indirectly related to the specific recommendations or views
contained in this research report. Our European Policy for Managing Research Conflicts of Interest is
available at www.stifel.com.
For a price chart with our ratings and any applicable target price changes for MDSO go to
http://sf.bluematrix.com/bluematrix/Disclosure?ticker=MDSO
The rating and target price history for Medidata Solutions, Inc. and its securities prior to February 25, 2015, on
the above price chart reflects the research analyst's views under a different rating system than currently utilized
at Stifel. For a description of the investment rating system previously utilized go to.www.stifel.com.
Stifel or an affiliate is a market maker or liquidity provider in the securities of Medidata Solutions, Inc..
Medidata Solutions Primer Book
22
Disclosures
The equity research analyst(s) responsible for the preparation of this report receive(s) compensation based on
various factors, including Stifel’s overall revenue, which includes investment banking revenue.
Our investment rating system is three tiered, defined as follows:
BUY – We expect a total return of greater than 10% over the next 12 months with total return equal to the
percentage price change plus dividend yield.
HOLD – We expect a total return between -5% and 10% over the next 12 months with total return equal to the
percentage price change plus dividend yield.
SELL – We expect a total return below -5% over the next 12 months with total return equal to the percentage
price change plus dividend yield.
Occasionally, we use the ancillary rating of SUSPENDED (SU) to indicate a long-term suspension in rating
and/or target price, and/or coverage due to applicable regulations or Stifel policies. SUSPENDED indicates the
analyst is unable to determine a “reasonable basis” for rating/target price or estimates due to lack of publicly
available information or the inability to quantify the publicly available information provided by the company and it
is unknown when the outlook will be clarified. SUSPENDED may also be used when an analyst has left the firm.
Of the securities we rate, 54% are rated Buy, 40% are rated Hold, 1% are rated Sell and 5% are rated
Suspended.
Within the last 12 months, Stifel or an affiliate has provided investment banking services for 19%, 7%, 5% and
5% of the companies whose shares are rated Buy, Hold, Sell and Suspended, respectively.
Medidata Solutions Primer Book
23
Disclosures
Additional Disclosures
Please visit the Research Page at www.stifel.com for the current research disclosures and respective target
price methodology applicable to the companies mentioned in this publication that are within Stifel's coverage
universe. For a discussion of risks to target price please see our stand-alone company reports and notes for all
Buy-rated and Sell-rated stocks.
The information contained herein has been prepared from sources believed to be reliable but is not guaranteed
by us and is not a complete summary or statement of all available data, nor is it considered an offer to buy or
sell any securities referred to herein. Opinions expressed are subject to change without notice and do not take
into account the particular investment objectives, financial situation or needs of individual investors. Employees
of Stifel, or its affiliates may, at times, release written or oral commentary, technical analysis or trading strategies
that differ from the opinions expressed within. Past performance should not and cannot be viewed as an
indicator of future performance.
As a multi-disciplined financial services firm, Stifel regularly seeks investment banking assignments and
compensation from issuers for services including, but not limited to, acting as an underwriter in an offering or
financial advisor in a merger or acquisition, or serving as a placement agent in private transactions.
Affiliate Disclosures
“Stifel”, includes Stifel Nicolaus & Company (“SNC”), a US broker-dealer registered with the United States
Securities and Exchange Commission and the Financial Industry National Regulatory Authority and Stifel
Nicolaus Europe Limited (“SNEL”), which is authorized and regulated by the Financial Conduct Authority
(“FCA”), (FRN 190412) and is a member of the London Stock Exchange.
Registration of non-US Analysts: Any non-US research analyst employed by SNEL contributing to this report
is not registered/qualified as a research analyst with FINRA and is not an associated person of the US broker-
dealer and therefore may not be subject to NASD Rule 2711 or NYSE Rule 472 restrictions on communications
with a subject company, public appearances, and trading securities held by a research analyst account.
Medidata Solutions Primer Book
24
Disclosures
Country Specific and Jurisdictional Disclosures
United States: Research produced and distributed by SNEL is distributed by SNEL to “Major US Institutional
Investors” as defined in Rule 15a-6 under the US Securities Exchange Act of 1934, as amended. SNEL is a non-
US broker-dealer and accordingly, any transaction by Major US Institutional Investors in the securities discussed
in the document would need to be effected by SNC. SNC may also distribute research prepared by SNEL
directly to US clients that are professional clients as defined by FCA rules. In these instances, SNC accepts
responsibility for the content. Research produced by SNEL is not intended for use by and should not be made
available to retail clients, as defined by the FCA rules.
Canadian Distribution: Research produced by SNEL is distributed in Canada by SNC in reliance on the
international dealer exemption. This material is intended for use only by professional or institutional investors.
None of the investments or investment services mentioned or described herein is available to other persons or to
anyone in Canada who is not a “permitted client” as defined under applicable Canadian securities law.
UK and European Economic Area (EEA): This report is distributed in the EEA by SNEL, which is authorized
and regulated in the United Kingdom by the FCA. In these instances, SNEL accepts responsibility for the
content. Research produced by SNEL is not intended for use by and should not be made available to non-
professional clients.
In jurisdictions where Stifel is not already licensed or registered to trade securities, transactions will only be
affected in accordance with local securities legislation which will vary from jurisdiction to jurisdiction and may
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Additional information is available upon request
© 2015 Stifel. This report is produced for the use of Stifel customers and may not be reproduced, re-distributed
or passed to any other person or published in whole or in part for any purpose without the prior consent of Stifel.
Stifel, Nicolaus & Company, Incorporated, One South Street, Baltimore, MD 21202.

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Mdso primer book

  • 1. December 2015 Digital Healthcare / Healthcare Technology Medidata Solutions (MDSO) Primer Book Thesis: Our investment hypothesis on MDSO holds that the company remains poised to be a long-term winner as the development of biopharmaceutical products, specifically outsourced solutions, becomes more technologically driven over time. Steve Rubis (214) 706 - 9451 rubiss@stifel.com Stifel does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. All relevant disclosures and certifications appear on pages 21 – 24 of this report.
  • 2. Medidata Solutions Primer Book 1 MDSO Investment Hypothesis The Evolving Biopharma Business Model Three Existential Questions for MDSO Investors Cross Over Debates Key Risks The Electronic Data Capture (EDC) Market Opportunity The FDA Regulatory Environment The Evolving Productization Landscape The Point to Platform Shift Value Proposition MDSO mHealth Clinical Trial Contract Research Organizations (CROs) and MDSO Utilization Platform Customer Analysis Customer Analysis Company Statistics Clinical Trial Statistics Competition M&A Opportunities Model Table of Contents
  • 3. Medidata Solutions Primer Book 2 MDSO Investment Thesis Sources: Stifel Research The MDSO Investment Hypothesis Our investment hypothesis on MDSO holds that the company remains poised to be a long-term winner as the development of biopharmaceutical products, specifically outsourced solutions, becomes more technologically driven over time. We believe that as the FDA drives clinical trials toward complete digitization, prescription drug pricing pressures require new ways of creating products, and precision / personalized medicine leads to more complex therapies that outsourcing will focus less on people and more on technology. The Key Drivers of Our Investment Hypothesis, Include: The FDA Regulatory Environment • Complete Digitization of Clinical Trial Data Submissions A Strong EDC Market Opportunity • FDA Digitization Makes Pen and Paper Obsolete Evolving Biopharma Productization • Pricing Pressure Disrupts Product Development Evolution / Adoption of mHealth / Wearables • Pricing Issues Drive Focus on New Opportunities Platform Value Proposition • FDA, Pricing Pressure, and Evolving Technologies Combine to Create a Strong and Sticky Value Proposition
  • 4. Medidata Solutions Primer Book 3 The Evolving Biopharma Business Model Old Clinical Trial and Product Paradigm Clinical Trials The major revenue growth lever of the old clinical trial paradigm revolved around price What Types of Data? • Adherence • Comparative Efficacy • Real World Efficacy • Utilization Drivers of the NewParadigm • $2.7T in Healthcare costs are driving cost rationalization • $2.6B to develop a drug is unsustainable LT • CMS' push to outcomes based reimbursement The Era of Biopharma Productization: We believe MDSO must illustrate new capabilities and a strong value proposition which revolves around the data requirements of an outcomes based reimbursement environment. MDSO and the Era of BiopharmaProductization Statistical Significance Product Revenue = Price X Quantity New Clinical Trial and Product Paradigm Clinical Trials Statistical Significance + Verification Product Revenue = Price X Quantity + DATA Price no longer represents the magical hammer of revenue growth, as biopharma companies must continuously prove their products worth in order to maintain pricing power. Key Indicators of Changing Environment • Focus on mHealth - Roche, NVS, GSK, BIIB, et al. • Rave + TSDV+ mHealth, but what else? • Precision Medicine Sources: Stifel Research
  • 5. Medidata Solutions Primer Book 4 We Believe MDSO Faces Three Existential Questions Question 1: Is MDSO Well Positioned for Business Model Disruption in Biopharma Stemming from Pricing Pressures? Our View: We believe MDSO may be well positioned to benefit from looming business model disruption stemming from outcomes driven pricing and reimbursement. Biopharma sponsors need new and innovative ways to ensure product development meets outcomes requirements e.g., adherence, comparative efficacy, real world efficacy, and utilization. We believe the fully unified, cloud-based platform of MDSO will help biopharma sponsors navigate the challenging environment. Question 2: What Capabilities Does MDSO Offer to Biopharma Sponsor Clients to Help Navigate Looming Business Model Disruption Due to Pricing Concerns. Our View: We believe MDSO needs to illustrate the value proposition associated with new and current capabilities that will help biopharma sponsors navigate business model disruption stemming from outcomes based reimbursement and pricing. Currently, MDSO provides quite a bit of benchmarking and analytical insight around trial site performance. In our view, cloud-based platforms with robust intelligence regarding a certain portion of the platform are typically able to replicate such intelligence around additional portions of the platform. Question 3: Has the MDSO platform value proposition strengthened in FY15 due to new new products (TSDV and Patient Cloud)? Our View: We believe the development of Targeted Source Data Verification and the Patient Cloud (mHealth) provide the strongest platform value proposition in recent memory. We believe the combination of Rave, TSDV, and Patient Cloud seems well positioned for the significant focus on mHealth and more efficient clinical trials among clients. We believe the FDA clinical trial data submission backdrop provides a further tailwind. Three Existential Questions for MDSO Investors Sources: Stifel Research
  • 6. Medidata Solutions Primer Book 5 Debate 1: Will FDA’s Digitization of Clinical Trial Data Submissions Positively Impact MDSO? Our View: We believe the FDA’s focus on completely digitizing the clinical trial data submission process provides a significant tailwind that will help push many sponsors toward platform adoption, especially in light of the strong value proposition linking Rave, TSDV, and Patient Cloud. Debate 2: Does the FDA Fully Support the Use of mHealth in Clinical Trials? Our View: We believe the FDA is quite interested in the utilization of mHealth in clincial trials. We believe the recent symposium hosted by MDSO and the New York Academy of Sciences illustrated this view. The industry realizes mHealth may provide a tool to capture more holistic data. Additionally, mHealth remains important given the number of patient driven clinical trial end points. Debate 3: Is the MDSO Clinical Cloud Too Expensive? Our View: We recognize that the MDSO clinical cloud may be expensive to biopharma sponsors and CROs operating at the lower end of the market. Nevertheless, we believe strong utilization among top 50 pharma, additional platform deals, and continued rescue activity suggest the platform exhibits strong value despite apparent price concerns. Debate 4: Can the Market Continue to Support Mid-Teens EDC (Rave) Growth? Our Take: We believe the FDA’s push to completely digitized clinical trial data submissions provides a tailwind to EDC growth. We provide more detail on the “Electronic Data Capture (EDC) Market Opportunity” slide below. Debate 5: Is MDSO’s TAM More Limited Than Investors Believe? Our Take: We believe MDSO’s TAM is likely between $4B and $5B, whereas the company’s long-term TAM may be $8B to $10B or more. We believe the company established the NT and LT TAM opportunities at its 2013 Investor Day meeting. Based on competitor commentary, we believe MDSO’s TAM estimate for mHealth, roughly $1B, may be conservative. Debate 6: Are Negative Industry Participant Comments Believable? Our Take: We believe investors should be skeptical of negative industry participant comments regarding MDSO. In our view, the negative commentary put forth by shorts is often biased by CROs or entities that compete with MDSO. MDSO Cross Over Debates Sources: Stifel Research
  • 7. Medidata Solutions Primer Book 6 MDSO Key Risks Sources: Stifel Research The Key Risks to Our MDSO Investment Hypothesis Long-Term Growth Rate Trajectory • A key concern among many investors revolves around MDSO’s long-term growth rate • Historically, management pointed to 20% y/y to 25% y/y revenue growth • Investors are concerned management may revise the growth range lower e.g., 17% y/y to 23% y/y Professional Services Revenues • The primary source of recent fundamental underperformance stems from professional services revenues • Professional Services revenues are less predictable due to longer cycle times at CROs Biopharma R&D Funding • A major deceleration or decline in R&D funding across biopharma sponsors would lead to fundamental performance pressure at MDSO Clinical Trial Starts / Activity • We believe clinical trial starts are a key indicator for MDSO • Clinical trial starts have increased each year since the mid-2000s • 2015 may mark the first year clinical trial starts decelerate Lack of Value-Add Product Innovation • A primary differentiating factor around the MDSO story revolves around product innovation • MDSO became an industry leader by innovating more than previous market leaders • The company must continue to evolve the platform forward to meet the needs of the new pricing environment, as well as more complex products (precision medicine)
  • 8. Medidata Solutions Primer Book 7 The Electronic Data Capture (EDC) Market Opportunity Sources: Stifel Research Key Controversy: MDSO bears continuously point to the belief that the EDC market is fully penetrated and cannot provide continued growth to MDSO. We believe the EDC market opportunity remains attractive and can continue to support growth. What Is Electronic Data Capture (EDC)? • EDC represents a computerized system that facilitates the collection of clinical trial data in an electronic format. • EDC can increase data accuracy and decrease time to collect data associated with clinical studies • EDC systems are beneficial for late-phase (phase III to IV) studies Our Key Assumptions Regarding the EDC Market • We believe by mid-2017 all new clinical trials will be electronic • Today, approximately 70% of clinical trials are digitized • We believe MDSO represents between 40% and 50% of these digitized trials Our View of the EDC Market Opportunity Today The EDC Market We Believe MDSO can 1. Take Share from Competitors and 2. Take Share from Undigitized Trials Undigitized Trials = 70% MDSO Represents Between 40% and 50% of digital trials Digitized Trials = 70% Competitors Represent Between 20% and 30% of digital trials All Trials Must Be Digital By Mid-2017
  • 9. Medidata Solutions Primer Book 8 The FDA Regulatory Environment Sources: Stifel Research The Regulatory Environment FDA and digitization of clinical trial data submissions • Two major deadlines are driving the digitization of clinical trial data submissions • 12/17/16 – required data standards • 5/5/17 – eCTD • Digital data submissions continue to increase: 55% in FY13, 64% in FY14, and 71% FY15 (as of Sept.) FDA Comments on mHealth from NYAS conference • Mobile technologies have enormous potential to make new physiological measurements • Remote transmission of data may change the way trials are done • There are no regulatory restrictions to use of these technologies • The questions to be answered relate to meaningful clinical effects and reliability of the data FDA pilot for EHR to EDC connectivity • The FDA continues to evaluate efforts to seamlessly link EDC to EHRs FDA May Look to Do More with Digital Trials • Think Efforts Around Fraud and Waste 32 17 5 16 48 24 54 84 Endpoints in NDAs 2007 - 2015 (n = 280) 127 24 8 55 63 64 81 189 Endpoints in Studies 2007 - 2015 (n = 611)
  • 10. Medidata Solutions Primer Book 9 The Evolving Productization Landscape and the Impact of Pricing What Seems to Be Driving the New Clinical Trials Paradigm? Complex Therapeutic Environment • Product development collaboration • Precision medicine • The need for an Enterprise Resource Planning (ERP) for clinical trials • Several companies (INC Research, Merck, and Novartis, et al.) see technological innovation associated with clinical trials coming from non-CROs • Pricing Pressures • Hepatitis C – Viekira Pak versus Harvoni • PCSK9 inhibitor drugs – Amgen and Regeneron • Indication specific pricing • Greater emphasis on risk sharing monetization structures What Types of Data? • Adherence • Comparative Efficacy • Real World Efficacy • Utilization Drivers of the New Paradigm • $2.7T in Healthcare costs are driving cost rationalization • $2.6B to develop a drug is unsustainable LT • CMS' push to outcomes based reimbursement New Clinical Trial and Product Paradigm Clinical Trials Statistical Significance + Verification Product Revenue = Price X Quantity + DATA Price no longer represents the magical hammer of revenue growth, as biopharma companies must continuously prove their products worth in order to maintain pricing power. Key Indicators of Changing Environment • Focus on mHealth - Roche, NVS, GSK, BIIB, et al. • Rave + TSDV+ mHealth, but what else? • Precision Medicine Sources: Stifel Research
  • 11. Medidata Solutions Primer Book 10 MDSO and the Point to Platform Shift Value Proposition The MDSO Point-to-PlatformShift • The Shift Entails a Long Cycle; One Year Plus • We See the Possibilityfor Three Platform Deals in FY15 Clinical Trials MDSO Modules Initial Agreement First Expansion: More Trials Second Expansion: More Products Third Expansion: All Clinical Trials Fourth Expansion: Enterprise Customer Final Expansion: Platform Customer Single Trial Single Product (LikelyMedidata Rave) Single Trial Works; Expands to Several Trials Still Single Product (LikelyMedidata Rave) Running SeveralTrials on MDSO Multiple Products; LikelyRave + Another Module (Coder, Gateway, Balance) Client Now Runs All Clinical Trial Volume on MDSO Platform Multiple Products; LikelyRave + Another Module (Coder, Gateway, Balance) Client Runs Most, If Not All Trial Volume on MDSO Client Utilizes Core Products (4 Total): Rave + Gateway+ Coder + Balance Client Runs All Trial Volume on MDSO Client Utilizes All MDSO Modules: Rave + Gateway+ Coder + Balance + TSDV + Patient Cloud The Evolving Client / MDSO Relationship Initially, An Interesting, But Not Must Have Solution • Competitors MayDo Some Modules Better Over Time, Evolves Into a Must Have Solution • Drivers - Pricing, Complexity, Efficiency Sources: Stifel Research
  • 12. Medidata Solutions Primer Book 11 MDSO mHealth Clinical Trial Analyzing MDSO’s MOVE-2014 Clinical Trial – mhealthclinicaltrials.com MDSO sponsored a study to illustrate the value of mHealth technology within clinical trials • Equipped patients with a Fitbit Flex and iPhone • Provided a mobile app to capture diary and quality of life data (Patient Cloud) • Over eight weeks, MDSO tracked the effect of sensors, wearables, and apps on health outcomes in overweight people with Type 2 Diabetes The MOVE-2014 Results: MDSO illustrated that studies can successfully instrument patients in a clinical trial Data Quality • Higher Visibility of Data Led to Higher Data Quality - Outliers may be a function of device quality issues • Calculated sleep efficiency and illustrated implausibility of an outlier • Verified an outlier of 35,000 steps in a single day Patient Compliance • Compliance is an Important Data Quality Check – High Compliance Associated with Wearing a Tracker; Sleep Mode Was a Problem • Subjects wore devices over 90% of the time • Subjects failed to put devices in sleep mode consistently • Subjects were mostly compliant around completing questionnaires via a mobile app Observations • mHealth Data Yields Many Possible Clinical Insights – Data Correlations Exist • Pain vs. BMI: highest levels of pain resulted in lowest BMI reduction • Analyzed a subject cluster who achieved both blood glucose and BMI reduction to understand phenotypic (behavioral) characteristics on results Sources: Company documents and mhealthclinicaltrials.com
  • 13. Medidata Solutions Primer Book 12 CROs Continue to Utilize More of MDSO • MDSO product density among CRO partners continues to increase over time • We estimate Inc Research, Theorem Clinical, and PRA International are MDSO platform customers • While CRO adoption / utilization of Rave remains strong, CROs are increasing adoption of Coder, Balance, TSDV, and the Patient Cloud Contract Research Organizations (CROs) and MDSO Utilization 1 1 1 4 7 9 20 7 10 Products 9 Products 8 Products 7 Products 6 Products 5 Products 4 Products 3 Products 2 Products 1 Product 0 Products CRO Product Density of MDSO Modules 43 5 16 1 3 11 2 7 7 Medidata Rave Medidata Rave Safety Gateway Medidata Coder Medidata Designer Medidata Grants Manager Medidate Balance Medidata CTMS Medidata TSDV Medidata Patient Cloud CROs Using Medidata Producs (n=43) From June to October, CRO utilization of Rave, Coder, Grants Manager, Balance, and Patient Cloud increased. The MDSO CRO Opportunities 1. CRO customers seem to be adopting more of the MDSO cloud. 2. MDSO enterprise / platform CROS seem to be increasing We estimate MDSO has roughly two to six enterprise clients and roughly one to three platform CRO clients. Sources: Stifel Research
  • 14. Medidata Solutions Primer Book 13 MDSO Platform Customer Analysis Sources: Stifel Research Biopharma Sponsors Contract Research Organizations (CROs) Johnson and Johnson Alcon (subsidiary of Novartis) GlaxoSmithKline Platform Deals Delayed to 4Q15, Our Guess: Astellas - INC Research Cust. Otsuka - INC Research Cust. INC Research Theorem Clinical PRA International Platform deals have been a major focus since 2012. Deals have been slow to materialize due to long sales and transformation cycles at sponsor and CRO clients. In our view, the platform value proposition seems much stronger with the inclusion of Targeted Source Data Verification (TSDV) and the Patient Cloud (mHealth). We think the regulatory and price environment now lends clinical trial outsourcing to technology more than ever. An Overviewof Key MDSO Platform Customers Platform Value Proposition = Rave + TSDV + Patient Cloud + Significant Interest in mHealth (Roche, Novartis, GSK, Biogen, et al.) + FDA clinical trial data submission digitization efforts
  • 15. Medidata Solutions Primer Book 14 MDSO Customer Analysis Penetration Stats • 5 of top 50, roughly 10% • Top 50 penetration is 66% • Top 50 Direct is 54% penetration • Top 50 via CRO is 18% penetration Rank Company Direct User CRO Relationship At Least One Relationship 1 Novartis YES YES 2 Pfizer 3 Roche YES YES YES 4 Sanofi YES YES YES 5 Merck 6 Johnson & Johnson YES YES 7 GlaxoSmithKline YES YES 8 AstraZeneca YES YES 9 Gilead Sciences YES YES 10 AbbVie YES YES 11 Amgen YES YES 12 TEVA YES YES 13 Bayer YES YES 14 Eli Lilly YES YES YES 15 Novo Nordisk 16 Boehringer Ingelheim 17 Takeda YES YES 18 Bristol-Myers Squibb YES YES 19 Actavis 20 Astellas Pharma YES YES 21 Baxter International YES YES 22 Biogen YES YES 23 Merck KgA 24 Mylan YES YES 25 Daiichi Sankyo YES YES 26 Celgene YES YES 27 Otsuka YES YES 28 Allergan YES YES 29 Les Laboratories Servier 30 Shire YES YES 31 Abbott Laboratories YES YES 32 Sun Pharmaceutical 33 Valeant 34 CSL 35 Eisai 36 UCB 37 Fresenius 38 Chugai Pharmaceutical YES YES 39 Menarini YES YES 40 Grifols 41 Aspen Pharmacare YES YES 42 Hospira 43 Sumitomo Dainippon YES YES 44 Mitsubishi Tanabe 45 STADA 46 Mallinckrodt YES YES 47 Endo International YES YES 48 Alexion YES YES 49 Lundbeck YES YES 50 Kyowa Hakko Kirin YES YES Sources: Company documents and Stifel Research
  • 16. Medidata Solutions Primer Book 261 275 287 316 333 350 358 363 379 397 420 437 462 486 516 539 572 27.6% 27.3% 24.7% 14.9% 13.8% 13.4% 17.3% 20.4% 21.9% 22.4% 22.9% 23.3% 23.8% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 0 100 200 300 400 500 600 700 3Q11 4Q11 1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 3Q13 4Q13 1Q14 2Q14 3Q14 4Q14 1Q15 2Q15 3Q15 ClientGrowth(Y/Y) Clients Medidata Solutions Client Trends Clients Client Growth (Y/Y) 92 104 120 133 147 163 178 195 218 236 259 282 304 329 372 32% 33% 36% 38% 41% 45% 47% 49% 52% 54% 56% 58% 59% 61% 65% 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 0 50 100 150 200 250 300 350 400 1Q12 2Q12 3Q12 4Q12 1Q13 2Q13 3Q13 4Q13 1Q14 2Q14 3Q14 4Q14 1Q15 2Q15 3Q15 CustomersPurchasingMultiple Productsasa%ofTotalCustomers Clients Clients Are Adopting Multiple Solutions Multi-Product Customers Multi-Product Penetration 15 MDSO Company Statistics Sources: Company documents and Stifel Research
  • 17. Medidata Solutions Primer Book 16 Clinical Trial Statistics Changes in Protocol Complexity 2002 2012 Change Number of End Points 7 13 86% Number of Protocol Procedures 106 167 58% Number of Eligibility Criteria 31 50 61% Number of Countries 11 34 209% Number of Investigative Sites 124 196 58% Number of Patients Randomized 729 597 -18% Number of Data Points Collected per Patienta 500,000 929,203 86% 115 120 413 460 129 143 714 780 Protocol Ready to FPFV Protocol Ready to Drug Available Protocol Ready to LPLV Protocol Ready to Data Lock MedianDaysElapsed Simple Complex 2.4 2 2.6 3.6 2.3 6.9 5.6 6.8 8.5 8.3 Overall Phase I Phase II Phase III Phase IIIb/IV Amendments and ChangesPer Protocol Amendments Changes Per Amendment 43% 52% 37% 30% 38% Overall Phase I Phase II Phase III Phase IIIb/IV Protocol and Amendment Timing Amendments Sources: Company documents and Stifel Research
  • 18. Medidata Solutions Primer Book 17 Pen and Paper / Homegrown Systems • Many companies use proprietary legacy systems and rely on cobbling together disparate systems that are not often easily connected Contract Research Organizations (CROs) • Both MDSO competitor and MDSO client • CROs face the prospect of losing share to technology based solutions Oracle / Phase Forward • Prior market leader (Phase Forward) in Electronic Data Capture (EDC) • Largest competitor next to MDSO • Strength lies in ability to tie clinical trials seamlessly to financial systems Parexel Informatics (Perceptive Informatics) • Data and applications for clinical trials • Primary products include: EDC, CTMS, ePRO, RTSM, and medical imaging BioClinica • eClinical solutions provider • Core products include: EDC, CTMS, RTSM, RBM, and Optimization Medrio • Cloud-based eClinical solutions provider focused on the Phase I trial market Datatrak • An early player in EDC whose product suite now primarily focuses on EDC plus CTMS, Trial Design, Medical Coding, Randomization & Trial Supply Management, Safety, and Training Omnicomm • eClinical solutions provider focused on Phase I trials Veeva Systems • Veeva Vault – eTMF and expansion into study start-up and Vault RIM Competition Sources: Stifel Research
  • 19. Medidata Solutions Primer Book 18 M&A Opportunities We believe innovation in clinical trials represents a major area of investment focus for venture capital. Additionally, biopharma sponsor companies continue to talk about the need to completely re-configure product development. While we see MDSO as a leading innovator, we believe they will likely look to acquire technology, as well. As of September 30, 2015, MDSO held $492.9 million in cash and cash equivalents. Interesting M&A Opportunities for MDSO: We have no knowledge of any M&A negotiations or discussions between Medidata Solutions and any of the identified potential parties. In addition, the probabilities outlined below are based on our estimates CTMS (Clinical Trial Management System): While MDSO attempted to improve its offering in CTMS with a tuck in acquisition in 2011 (Clinical Force), we see CTMS as the Achillies heel of the platform. We have even heard of a company (Abbvie) look to Salesforce for CTMS; Salesforce does not provide a specific CTMS solution. goBalto: Provider of next generation solutions that facilitate a simpler and more efficient study start-up process. Essentially a tool that optimizes electronic Trial Master File (eTMF) and Clinical Trial Management Solutions (CTMS) functions. Medrio: eClinical software vendor primarily focused on the EDC market for phase I trials. Medrio might represent a tuck-in acquisition that would help MDSO in the phase I trial market. The company has facilitated 1,000+ studies across 500 clients since 2005. ePatientFinder: Software provider that helps healthcare providers learn about and direct relevant patients to clinical trials. The solution utilizes algorithms to match physicians with treatments relevant to patients based on EHR data. Virtual Clinical Trials: The focus on leveraging technology to bring clinical trial research to the patient’s home and local health system. Sources: Company documents and Stifel Research
  • 20. Medidata Solutions Primer Book 19 MDSO Model Sources: Company documents and Stifel Research Medidata Solutions, Inc. (MDSO) Statement of Income ($ in 000s, except per share) FY FYE FYE FYE 1Q14 2Q14 3Q14 4Q14 1Q15 2Q15 3Q15 4Q15 E FY Ends Dec 2014 2015 2016 2017 Mar-14 Jun-14 Sep-14 Dec-14 Mar-15 Jun-15 Sep-15 Dec-15 Subscription 280,041 343,954 415,496 496,518 63,811 68,947 71,547 75,736 78,749 83,929 88,878 92,398 Professional Services 55,030 56,096 59,462 63,624 12,829 14,276 14,449 13,476 13,691 14,155 14,235 14,015 TOTAL REVENUE 335,071 400,050 474,958 560,142 76,640 83,223 85,996 89,212 92,440 98,084 103,113 106,413 Subscription 45,576 49,252 61,078 64,350 11,086 11,221 11,413 11,856 11,473 12,354 12,489 12,936 Professional Services 39,344 41,725 44,002 46,285 9,713 9,753 9,582 10,296 10,703 10,557 10,304 10,161 Cost of revenues (excludes D&A) 84,920 90,977 105,080 110,636 20,799 20,974 20,995 22,152 22,176 22,911 22,793 23,097 Gross Profit 250,151 309,073 369,878 449,507 55,841 62,249 65,001 67,060 70,264 75,173 80,320 83,316 Research and Development 71,757 93,842 112,860 134,434 17,789 17,311 17,677 18,980 21,911 22,519 24,192 25,220 Sales and Marketing 83,435 102,845 119,515 137,235 20,732 20,425 21,004 21,274 24,318 25,724 25,881 26,922 General and Administrative 69,111 81,873 90,242 109,228 17,046 17,373 17,865 16,827 20,569 21,943 19,143 20,218 Other 5,784 0 0 0 0 0 4,880 904 0 0 0 - Operating Income 20,064 30,513 47,262 68,610 274 7,140 3,575 9,075 3,466 4,987 11,104 10,956 Interest Expense (15,368) (15,817) (15,297) (15,297) (3,781) (3,827) (3,849) (3,911) (3,958) (3,997) (4,038) (3,824) Interest Income 1,814 2,624 2,956 2,956 395 420 465 534 534 612 739 739 Other Income, Net 4 (22) 217 60 34 (28) 0 (2) (34) (34) 3 43 Pretax income 6,514 17,297 35,137 56,328 (3,078) 3,705 191 5,696 8 1,568 7,808 7,913 Income Taxes 422 6,202 14,072 22,559 (1,263) 1,409 30 246 (149) 55 3,127 3,169 Tax Rate 6.5% 36% 40.0% 40.0% 41.0% 38.0% 15.7% 4.3% NM 3.5% 40.0% 40.0% Net Income, pro forma, cont ops 6,092 11,095 21,065 33,770 (1,815) 2,296 161 5,450 157 1,513 4,681 4,744 Basic EPS, pro forma, cont ops 0.12$ 0.21$ 0.39$ 0.61$ (0.03)$ 0.04$ 0.00$ 0.10$ 0.00$ 0.03$ 0.09$ 0.09$ Diluted EPS, pro forma, cont ops 0.11$ 0.20$ 0.37$ 0.59$ (0.03)$ 0.04$ 0.00$ 0.10$ 0.00$ 0.03$ 0.08$ 0.08$ Shares outstanding Basic 52,558 53,720 54,318 54,933 52,109 52,457 52,772 52,895 53,257 53,647 53,933 54,043 Diluted 54,338 56,333 57,072 57,687 52,109 54,828 55,069 55,347 55,658 56,191 56,687 56,797 Cash EPS (before stock comp) 0.74$ 0.87$ 1.13$ 1.43$ 0.11$ 0.17$ 0.20$ 0.25$ 0.17$ 0.22$ 0.25$ 0.24$ Adjusted EBITDA 74,236 92,038 115,957 144,846 12,508 18,379 21,200 22,149 17,689 21,760 25,957 26,632 Percentage of Revenues Gross profit, pro forma 74.7% 77.3% 77.9% 80.2% 72.9% 74.8% 75.6% 75.2% 76.0% 76.6% 77.9% 78.3% Research and Development 21.4% 23.5% 23.8% 24.0% 23.2% 20.8% 20.6% 21.3% 23.7% 23.0% 23.5% 23.7% Sales and Marketing 24.9% 25.7% 25.2% 24.5% 27.1% 24.5% 24.4% 23.8% 26.3% 26.2% 25.1% 25.3% General and Administrative 20.6% 20.5% 19.0% 19.5% 22.2% 20.9% 20.8% 18.9% 22.3% 22.4% 18.6% 19.0% Operating Income 6.0% 7.6% 10.0% 12.2% 0.4% 8.6% 4.2% 10.2% 3.7% 5.1% 10.8% 10.3% Adjusted EBITDA 22.2% 23.0% 24.4% 25.9% 16.3% 22.1% 24.7% 24.8% 19.1% 22.2% 25.2% 25.0% Year / Year Growth Rate Net Sales 21.0% 19.4% 18.7% 17.9% 21.2% 22.3% 21.2% 19.6% 20.6% 17.9% 19.9% 19.3% Subscription 22.9% 22.8% 20.8% 19.5% 26.0% 22.4% 23.5% 20.3% 23.4% 21.7% 24.2% 22.0% Professional Services 12.5% 1.9% 6.0% 7.0% 1.8% 21.8% 11.1% 16.2% 6.7% -0.8% -1.5% 4.0% Adjusted EBITDA 10.5% 24.0% 26.0% 24.9% -12.0% 5.1% 16.4% 28.1% 41.4% 18.4% 22.4% 20.2% Operating Income -16.0% 52.1% 54.9% 45.2% -96.1% -19.2% -62.3% 1165.0% -30.2% 210.6% 20.7% Pretax Income -64.6% 165.5% 103.1% 60.3% -142.1% -58.2% -97.4% -57.7% 3988.0% 38.9% Net Income -63.4% 82.1% 89.9% 60.3% -131.8% -55.0% -96.9% 836.4% -34.1% 2807.5% -13.0% Diluted EPS -64.5% 81.8% 85.0% 59.5% -127.3% -60.0% -100.0% 900.0% -25.0% -20.0% Guidance from Company Subscription (Revised as of 3Q15) $336.0M to $345.0M $84.4M to $93.4M Professional Services Revenues (Revised as of 3Q15) $56.0M to $57.0M $13.9M to $14.9M Total Revenue (Revised as of 3Q15) $392.0M to $402.0M $98.4M to $108.4M GAAP Operating Income (Revised as of 3Q15) $28.0M to $31.0M $8.4M to $9.9M Adjusted EBITDA $90.0M to $96.0M $24.6M to $27.6M Adjusted Non-GAAP Net Income $47.0M to $50.5M Source: Company Reports and Stifel estimates Steve Rubis - (214) 706 - 9451 Updated: October 27, 2015
  • 21. Medidata Solutions Primer Book 20 Bibliography of Pertinent MDSO Notes A List of What We Believe to Be Our Most Relevant Research on MDSO 10/27/15 – MDSO: 3Q15 Better Than First Thought; Long-Term Thesis Intact; Attractive Entry Point 10/23/15 – Digital Health Check-Up: Why We Think the World May Be Changing 10/14/15 – Digital Health Check-Up: Mobile Health Conference Helps Frame MDSO Platform Value Proposition 10/12/15 - MDSO: Does It Make Sense to Scale in Current Environment? We Say Yes; Maintain Buy 9/30/15 - MDSO: What We Learned at SCDM 2015 About EDC and Digitization 9/30/15 – Digital Health Check-Up: Thoughts from SCDM and the Digitization of Clinical Trials 9/25/15 – Digital Health Check-Up: Connect 2015 and the Internet of Medical Things (IoMT) 9/21/15 - MDSO: Fundamentals Unchanged; EDC Remains Sticky; mHealth Continues to Evolve; Buy 9/14/15 – Digital Health Check-Up: The Digital Health Investment Roadmap for 2H15 and Beyond 8/4/15 – MDSO: CRO 2Q15 Commentary Suggests Strong 2H15 for MDSO; Reiterate Buy 4/17/15 – MDSO: 1Q15 Preview; the Era of Biopharma Productization; CRO Product Density; Buy 2/1/15 – MDSO: Revisiting the Impact of NVS / QCOM Life Announcements; 4Q14 Preview, Maintain Buy 6/16/14 – Initiating Coverage of Medidata Solutions with a Buy Rating; Drug Trial Cloud
  • 22. Medidata Solutions Primer Book 21 Disclosures Important Disclosures and Certifications I, Steven A. Rubis, certify that the views expressed in this research report accurately reflect my personal views about the subject securities or issuers; and I, Steven A. Rubis, certify that no part of my compensation was, is, or will be directly or indirectly related to the specific recommendations or views contained in this research report. Our European Policy for Managing Research Conflicts of Interest is available at www.stifel.com. For a price chart with our ratings and any applicable target price changes for MDSO go to http://sf.bluematrix.com/bluematrix/Disclosure?ticker=MDSO The rating and target price history for Medidata Solutions, Inc. and its securities prior to February 25, 2015, on the above price chart reflects the research analyst's views under a different rating system than currently utilized at Stifel. For a description of the investment rating system previously utilized go to.www.stifel.com. Stifel or an affiliate is a market maker or liquidity provider in the securities of Medidata Solutions, Inc..
  • 23. Medidata Solutions Primer Book 22 Disclosures The equity research analyst(s) responsible for the preparation of this report receive(s) compensation based on various factors, including Stifel’s overall revenue, which includes investment banking revenue. Our investment rating system is three tiered, defined as follows: BUY – We expect a total return of greater than 10% over the next 12 months with total return equal to the percentage price change plus dividend yield. HOLD – We expect a total return between -5% and 10% over the next 12 months with total return equal to the percentage price change plus dividend yield. SELL – We expect a total return below -5% over the next 12 months with total return equal to the percentage price change plus dividend yield. Occasionally, we use the ancillary rating of SUSPENDED (SU) to indicate a long-term suspension in rating and/or target price, and/or coverage due to applicable regulations or Stifel policies. SUSPENDED indicates the analyst is unable to determine a “reasonable basis” for rating/target price or estimates due to lack of publicly available information or the inability to quantify the publicly available information provided by the company and it is unknown when the outlook will be clarified. SUSPENDED may also be used when an analyst has left the firm. Of the securities we rate, 54% are rated Buy, 40% are rated Hold, 1% are rated Sell and 5% are rated Suspended. Within the last 12 months, Stifel or an affiliate has provided investment banking services for 19%, 7%, 5% and 5% of the companies whose shares are rated Buy, Hold, Sell and Suspended, respectively.
  • 24. Medidata Solutions Primer Book 23 Disclosures Additional Disclosures Please visit the Research Page at www.stifel.com for the current research disclosures and respective target price methodology applicable to the companies mentioned in this publication that are within Stifel's coverage universe. For a discussion of risks to target price please see our stand-alone company reports and notes for all Buy-rated and Sell-rated stocks. The information contained herein has been prepared from sources believed to be reliable but is not guaranteed by us and is not a complete summary or statement of all available data, nor is it considered an offer to buy or sell any securities referred to herein. Opinions expressed are subject to change without notice and do not take into account the particular investment objectives, financial situation or needs of individual investors. Employees of Stifel, or its affiliates may, at times, release written or oral commentary, technical analysis or trading strategies that differ from the opinions expressed within. Past performance should not and cannot be viewed as an indicator of future performance. As a multi-disciplined financial services firm, Stifel regularly seeks investment banking assignments and compensation from issuers for services including, but not limited to, acting as an underwriter in an offering or financial advisor in a merger or acquisition, or serving as a placement agent in private transactions. Affiliate Disclosures “Stifel”, includes Stifel Nicolaus & Company (“SNC”), a US broker-dealer registered with the United States Securities and Exchange Commission and the Financial Industry National Regulatory Authority and Stifel Nicolaus Europe Limited (“SNEL”), which is authorized and regulated by the Financial Conduct Authority (“FCA”), (FRN 190412) and is a member of the London Stock Exchange. Registration of non-US Analysts: Any non-US research analyst employed by SNEL contributing to this report is not registered/qualified as a research analyst with FINRA and is not an associated person of the US broker- dealer and therefore may not be subject to NASD Rule 2711 or NYSE Rule 472 restrictions on communications with a subject company, public appearances, and trading securities held by a research analyst account.
  • 25. Medidata Solutions Primer Book 24 Disclosures Country Specific and Jurisdictional Disclosures United States: Research produced and distributed by SNEL is distributed by SNEL to “Major US Institutional Investors” as defined in Rule 15a-6 under the US Securities Exchange Act of 1934, as amended. SNEL is a non- US broker-dealer and accordingly, any transaction by Major US Institutional Investors in the securities discussed in the document would need to be effected by SNC. SNC may also distribute research prepared by SNEL directly to US clients that are professional clients as defined by FCA rules. In these instances, SNC accepts responsibility for the content. Research produced by SNEL is not intended for use by and should not be made available to retail clients, as defined by the FCA rules. Canadian Distribution: Research produced by SNEL is distributed in Canada by SNC in reliance on the international dealer exemption. This material is intended for use only by professional or institutional investors. None of the investments or investment services mentioned or described herein is available to other persons or to anyone in Canada who is not a “permitted client” as defined under applicable Canadian securities law. UK and European Economic Area (EEA): This report is distributed in the EEA by SNEL, which is authorized and regulated in the United Kingdom by the FCA. In these instances, SNEL accepts responsibility for the content. Research produced by SNEL is not intended for use by and should not be made available to non- professional clients. In jurisdictions where Stifel is not already licensed or registered to trade securities, transactions will only be affected in accordance with local securities legislation which will vary from jurisdiction to jurisdiction and may require that a transaction carried out in accordance with applicable exemptions from registration and licensing requirements. Non-US customers wishing to effect transactions should contact a representative of the Stifel entity in their regional jurisdiction except where governing law permits otherwise. US customers wishing to effect transactions should contact their US salesperson. Additional information is available upon request © 2015 Stifel. This report is produced for the use of Stifel customers and may not be reproduced, re-distributed or passed to any other person or published in whole or in part for any purpose without the prior consent of Stifel. Stifel, Nicolaus & Company, Incorporated, One South Street, Baltimore, MD 21202.