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PRA Health Sciences (Nasdaq: PRAH) | Company Profile, History, Competitors

 

PRA Health Sciences (NASDAQ: PRAH) is a contract research organization (CRO) that provides outsourced clinical development services to biotechnology and pharmaceutical companies. The company was founded in 1976 and headquartered in Raleigh, NC.

The company was founded in 1976 in Charlottesville, VA as the Anti-inflammatory Drug Study Group. It transitioned into a data management contract research organization and changed its name to Pharmaceutical Research Associates. PRA provides clinical development services for Phase I-IV trials. Their services include clinical study design, risk management, trial staffing and functional outsourcing, where PRA fully integrates into a client's clinical development trials.

Business Overview

PRA offers both traditional, project-based Phase I-IV services and also embedded embedded, functional outsourcing, and staffing services, also know as functional service provider (FSP0.

PRA has three main core service offerings:
  • Product Registration Provides study protocol for Phase IIb - IV clinical trials. Services include clinical trial management, project management, regulatory affairs, clinical monitoring services, safety and risk management, biostatistics and late stage services
  • Strategic Solutions Provides functional outsourcing (FSP) services where PRA's teams are fully integrated within the client's internal clinical development operations. PRA also provides staffing and commercialization services
  • Early Development Services Provides Phase I-IIa clinical trials and bioanalytical laboratory services

Product Registrations Segment

PRA provides the following key services for product registration services:
  • Clinical Trial Management Performs single site, multi-site clinical trials under an electronic trial master
  • Project Management Overseas drug development process, establishes work flow plans
  • Regulatory Affairs PRA employees represent customers during interactions with regulatory agencies
  • Therapeutic Expertise PRA helps companies with limited infrastructure, medical resources and therapeutic experience to achieve milestones in a cost effective maner
  • Clinical Operations Provides site management services for clinical trials
  • Data & Programming Collects and organizes clinical trial data. Manage data and generate reports
  • Safety & Risk Management Addresses safety procedures throughout the clinical trial process.
  • Biostatistcs & Medical Writing Encompasses biostatistics, medical writing, pharmacokinetics,statistical analysis, regulatory reporting.
  • Quality Assurance Services Continuously evaluate and improve process quality, conducts audits across all phases of trial
  • Late Phase Services Supports post-approval trials in marketing, safety, patient management and biomarker research

Strategic Solutions Segment

PRA helps optimize the client's internal infrastructure with its services for Phase II-IV clinical trials. PPA's key services include:
  • Embedded Solutions Redesigns existing systems through an analysis of quality, cycle time, productivity and service-level performance
  • Functional Services Provider Solutions Helps alleviate capacity issues by providing line management, training and support for one or more functions
  • Staff Augmentation Solutions Large personnel recruitment team to obtain additional expertise when necessary
  • Custom-Built Development Solutions Provides a supplemental team, uniquely designed for each customer and assists throughout the development process
  • Commercialization Services Helps with launch preparation and product life cycle management, stimulate providers and patients, determine post marketing commitments.

Early Development Services Segment

PRA helps provide services for Phase I and IIa trials and bioanalytical analysis. PRA has more than 1,000 early development specialists. PRA provides key questions including:
  • Phase I through IIa Studies Overseas drug development studies using their active pool of 100,000 early study participants, provides full pharmacy and manufacturing capabilities
  • Bioanalytical Laboratory Has two bioanalytical laboratories for sample processing. Capabilities include mass spectrometry, liquid biomarketr, specialized assays, mass balance and microdosing studies.
PRA has conducted more than 700 early developmental clinical trials and 200 bioanalytical studies in the last five years.

Customers

PRA has provided services to over 300 biopharma clients. PRA has been involved in more than 3,5000 clinical trials since 2000 and has supported the approval of over 70 drugs approved by the FDA.

As of 2017, PRA had a backlog of $2.4bn in projects awarded by customers.

Competitors

Its main competitors are IQVIA, Covance (Lab Corporation of America), ICON plc, PPDI, PAREXEL and Syneos Health.

History

The company was founded in 1976 in Charlottesville, Virginia as the Anti-inflammatory Drug Study Group. Less than a decade later, it transitioned into a data management contract research organization and changed its name to Pharmaceutical Research Associates.

In 1996, the company was acquired by private equity firm The Carlyle Group. In 2001, the company was acquired by private equity firm Genstar Capital. 2004, the company went public.

In 2007, the company was taken private again by Genstar Capital. In 2013, PRA was acquired by private equity firm KKR.

In 2013, PRA acquired ReSearch Pharmaceutical Services to begin serving CRO tasks to large pharma. In the same year, they also acquired CRI Lifetree, a CRO company focused on early stage clinical studies and one of the largest providers of patient populations. In 2014, PRA went public again.

In 2016, PRA signed a partnership agreement with Takeda Pharmaceuticals where PRA will manage an entire pipeline of studies for Takeda.

Management

Colin Shannon (CEO): Colin Shannon serves as CEO since 2010. Prior, he served as COO of the company. He previously worked for Pharmaceutical Product Development (PPDI) as EVP Global Clinical Operations and COO Europe.

Michael Bonello (CFO): Michael Bonello serves as CFO since 2018. Prior, he was Senior VP Accounting/Controller at the company. He had also worked as Controller at Cree and Genworth Financial. he also worked as an auditor at PriceWaterhouseCoopers LLP.

Financials

 $ USD in millions    2013    2014 2015 2016 2017
 Revenues $991 
$1,460 
$1,614 
$1,812 
$2,259 
 Gross Profit $306 
$407 
 $489 
 $547 
 $665 
 Operating Profit($34)
$57 
 $164 
 $162 
 $176 
 Net Income($88)($36)$82 
 $68 
 $87 
 EPS($2.23)($0.83)$1.29 
$1.06 
$1.39 

PRA Health Sciences, Inc.
 
  Type     Public
  Ticker     NASDAQ: PRAH
  Industry Healthcare
  Founded 1976
  Headquarters Raleigh, NC
  Revenues
$2.3n (2017)
  Employees 15,800 (2017)
  Website prahs.com