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Transcript of Mdso primer book
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 [email protected]
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 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
The Era of Biopharma Productization: We believe MDSO must illustrate new capabilities and a strong value proposition which revolvesaround the data requirements of an outcomes based reimbursement environment.
MDSO and the Era of Biopharma Productization
Statistical Significance ProductRevenue =
Price X Quantity
New Clinical Trial and Product Paradigm
ClinicalTrials
Statistical Significance
+Verification
ProductRevenue =
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
Competitorsand
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
248
55 63 6481
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
ClinicalTrials
Statistical Significance
+Verification
ProductRevenue =
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-Platform Shift
• The Shift Entails a Long Cycle; One Year Plus• We See the Possibility for 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 (Likely Medidata Rave)
Single Trial Works;Expands to Several Trials
Still Single Product (Likely Medidata Rave)
Running Several Trials on MDSOMultiple Products; Likely Rave + Another
Module (Coder, Gateway, Balance)
Client Now Runs All Clinical Trial Volume on MDSO Platform
Multiple Products; Likely Rave + 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 May Do 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
13
11
2
7 7
MedidataRave
MedidataRave Safety
Gateway
MedidataCoder
MedidataDesigner
MedidataGrants
Manager
MedidateBalance
MedidataCTMS
MedidataTSDV
MedidataPatient
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 tolong 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 Overview of 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 287316
333 350 358 363 379397
420437
462486
516539 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
Clie
nt
Gro
wth
(Y
/Y)
Clie
nts
Medidata Solutions Client Trends
Clients Client Growth (Y/Y)
92104
120133
147163
178195
218
236
259
282304
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
Cu
sto
me
rs P
urc
ha
sin
g M
ult
iple
P
rod
uc
ts a
s a
% o
f T
ota
l C
us
tom
ers
Clie
nts
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
413460
129 143
714780
Protocol Readyto FPFV
Protocol Readyto Drug Available
Protocol Readyto LPLV
Protocol Readyto Data Lock
Me
dia
n D
ays E
lap
se
d
Simple Complex
2.42
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 Changes Per 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
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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
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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
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Disclosures
The equity research analyst(s) responsible for the preparation of this report receive(s) compensation based on
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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
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Disclosures
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Medidata Solutions Primer Book
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Disclosures
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