Avion Pharmaceuticals

Avion Pharmaceuticals
Management Presentation
June 2, 2014
Michael Sullivan - President
Disclaimer
Forward-looking statements (statements which are not historical facts) in this presentation are made
pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are not promises or guarantees and investors are cautioned that all
forward-looking statements involve risks and uncertainties, including but not limited to the impact of
competitive products and pricing, product demand and market acceptance, new product
development, the regulatory environment, including without limitation, reliance on key strategic
alliances, availability of raw materials, fluctuations in operating results and other results and other
risks which will be detailed from time to time in the Company's filings with the Securities and
Exchange Commission. These statements are based on management's current expectations and
are naturally subject to uncertainty and changes in circumstances. We caution you not to place
undue reliance upon any such forward looking statements which speak only as of the date made.
Avion is under no obligation to, and expressly disclaims any such obligation to, update or alter its
forward-looking statements, whether as a result of new information, future events or otherwise.
Avion Pharmaceuticals
A Branded Specialty Pharmaceutical Company
Avion Pharmaceuticals
Executive Summary
Avion Pharmaceuticals
Avion Pharmaceuticals is a rapidly emerging leader as
a specialty provider of unique women’s health products.
In contrast to similar-sized and similar-aged pharmaceutical companies, Avion’s
model allows the Company to pursue an innovative, long-term product
development strategy concurrent with an active, profitable and strategically
relevant participation in the market – maximizing today’s opportunities while
building for tomorrow. This model is built on 4 core principles:
•
•
•
•
A low-overhead business structure
Long term approach with existing products through creative life cycle
management
An inquisitive and opportunistic acquisition strategy
A hybrid long-term / short-term product development program
Avion Pharmaceuticals Mission
Our goal is to become the leading Women’s Health and
Advanced Prescription Nutritional specialty
pharmaceutical company in the US.
We will provide products that deliver maximum benefit along the continuum of
care in women’s lives and those patients who can benefit from advanced
nutritional care. Understanding women’s health and matching products that
deliver positive support will help ensure improved lifestyles for women of all ages
and life stages and those paitent’s in need of advanced nutritional care.
At Avion, we work diligently to offer new delivery methods as well as
improvements to current products that will offer ease of use and adherence,
appropriate pricing with ease of access and beneficial health outcomes.
Avion Accelerated Go-To-Market Strategy
5
4
3
2
1
Identify gaps in women’s
healthcare products and areas
of opportunity in advanced
nutritional care and develop
distinctive solutions
Source or
develop unique
and proprietary
API to provide a
compelling sales
strategy while
ensuring full
protection
Commercialize
products quickly,
offer distinct
competitive
market
advantages and
strong business
growth
Leverage dedicated
experienced sales and
marketing team to
deliver flawless launch
execution and rapid
prescription uptake
Build continuing
network of scientific
and corporate
partnerships, along
with a vibrant Bus
Dev initiative to drive
opportunity
identification, swift
market entry and
penetration ensuring rapid
market uptake and
ongoing growth
Avion Pharmaceuticals – Markets Served & Portfolio Distribution
Percentage of Total Prescriptions Units By Segment
13%
11%
Women's Health
Hematinic
Dermatology
75%
Source: IMS Health Dec. 2013
Avion Pharmaceuticals
Our People
Our People
Mark Pugh
Chief Executive Officer
As Chief Executive Officer, Mark Pugh oversees the overall growth and
development of Avion Pharmaceuticals. Drawing from more than 20 years of
industry experience, Mr. Pugh has a documented record of success in
identifying and capturing new business opportunities to build high-profit, highgrowth corporations.
Prior to Acella, Mr. Pugh founded Alliant Pharmaceuticals, a pharmaceutical
company focused on the pediatric market. Alliant, which originated in 2004,
quickly grew to more than 120 employees within three years. The emerging
company was purchased by Sciele Pharmaceuticals in 2007.
Mr. Pugh's leadership in driving Alliant's growth earned the organization an
honorable mention by Catalyst Magazine as "one to watch," and Alliant
ranked #4 in Entrepreneur Magazine and PricewaterhouseCoopers’ “Hot 100”
ranking of the country’s fastest growing companies. In addition, Mr. Pugh was
selected in 2005 as one of the metro-Atlanta area’s “Top 40 Under 40” by the
Atlanta Business Chronicle and was the runner-up for the 2007 Ernst &
Young Entrepreneur of the Year Award.
Our People
Harold A Deas, Jr.
Chief Operating Officer
In his role as Chief Operating Officer, Art Deas manages the day-to-day
operations for Avion Pharmaceuticals. Mr. Deas previously held the position
of Vice President, Sales and Marketing for Alliant Pharmaceuticals, and was
an integral component in the company’s overall success. Prior to Alliant, Mr.
Deas served as Regional Sales Manager for Genentech Pharmaceuticals.
Mike Sullivan
President
Mike Sullivan has over 20 years of prescription pharmaceutical sales and
marketing experience with specific responsibilities and expertise in sales
management, managed care, trade, sales operations, product management,
and training. Mike’s experience includes start-up expertise as well as success
in traditional pharma . He was responsible for the commercial development
and successful launch of Ther-Rx Corporation, a Specialty Pharmaceutical
start-up where he was the principal lead responsible for building the
commercial team charged with the successful launch of over eight (8) new
products during his ten (10) year tenure with the organization that generated
more than $250M in sales.
Financial Summary - Primary Highlights
Gross Sales:
•$28m (2012)
•$42m (2013)
•$57m (2014 projected)
Annual Gross Sales Trend
$60,000,000
$50,000,000
EBITDA:
• $13m (2012)
•$15.5m (2013)
•$21.5m (2014 projected)
$40,000,000
$30,000,000
Gross Sales
$20,000,000
$10,000,000
$0
2012
Compound Annual Growth:
• 147% (2013 vs. 2012)
Net Margin (2013)
•95%
Gross Margin (2013)
•85%
2013
2014
(projected)
Annual EBITDA Trend
$25,000,000
$20,000,000
$15,000,000
EBITDA
$10,000,000
$5,000,000
$0
2012
2013
2014
(projected)
Our People
Art Deas
Chief Operating
Officer
Mike Sullivan
President
Mark Steffen
Senior Director
Trade and Managed
Care
Mary Claire
Kenworthy
Senior Product
Manager
Javaid Ahmed
Northeast District
Manager
Sakira Arora
Magda Mocarski
Joe Fry
Operations
Manager
Manager of
Operations
National
Frank DeRogatis
Northeast District
Manager
Dan Nicastro Mid
Atlantic District
Manager
Sales Manager
Dena Courneen
South District
Manager
Karen Savage
National Account
Manager
Jen Scrutchfield
Central District
Manager
Carolyn Hill
Director of HR
Vacant
Southwest District
Manager
Each District Manager has ten (10-13) Professional Sales Representatives
Robert Sims South
Central District
Manager
Shawn Bauer West
Coast District
Manager
Our People
Leader
Previous Company
Years of Experience
Director of Trade and Managed Markets
Sanofi – Ther-Rx Corporation
30
Director of Marketing
Glaxo – Ther-Rx Corporation
18
National Accounts Director
Advanced Biohealing -Sanofi – JSJ Derm
15
National Sales Director
Sanofi – Shire - Sepracor
16
District Manager
J&J - Ther-Rx – Azur Pharma
15
District Manager
Ther-Rx Corp - Sucampo – Pernix Pharma
14
District Manager
Biovail – Victory Pharma
17
District Manager
Ther-Rx Pharmaceuticals
8
District Manager
UCB – Ther-Rx Corp - Strativa
18
Manager of Human Resources
Loreal – Eaton Energy
23
President
UCB – Novartis - Sanofi- Ther-Rx Corp
18
The Avion leadership team has a unique blend of traditional pharma experience with a
documented track record of success in “Start-Up” Pharma and Specialty Pharma with a specific
therapeutic focus in Women’s Health, Dermatology, Nephrology, Oncology, and Hematology.
Market and Opportunity
Accelerated, Focused and Profitable
Accelerated, focused and profitable.
Avion Pharmaceuticals is built on a model that delivers near
term profitability while building long-term value as an
important specialty provider of products serving an
evergreen category. There are 4 elements to this model:
•
•
•
•
A low-overhead business structure
An ongoing and active participation in the market
An opportunistic acquisition strategy
A hybrid long-term / short-term product development program
Accelerated, focused and profitable.
•
•
•
•
Run a low cost pharmaceutical model
–
Pay for performance
–
Streamlined Marketing Strategy
–
Contract Manufacturing
–
Third Party Logistics Provider
Flawless Execution in Sales & Marketing
–
100 FTE’s, 8 RM’s (PHD’s)
–
Ongoing sales training – The Avion Way
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Call on over 15800 OB-Gyns in the U.S.
Maximize Sales Force Synergy
–
Launch novel products for Women’s Health
–
FerRivaFA™, Prenate® Mini, FaLessa™
Acquire opportunistic Women’s Health products / companies
–
Promotionally sensitive
–
Opportunities for price increase
Avion Low-Overhead Business Structure
Avion Pharmaceuticals leverages third parties to deliver
fundamental operations, along with exclusive licensing
agreements to secure proprietary rights to important IP
drug delivery and formulation technology.
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•
•
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Contract Manufacturing
3PL
Licensed specialty ingredients
Licensed delivery technology
National wholesaler presence and support
Avion Actively Participates in the Market – Chronology of Commercial Deployment
2012
Q1
Q2
2013
Q3
Product
Launches
Q4
Q1
Prenate MINI Promotion
launch
Xponent Data
Availability
Q2
2014
Q3
FeRiva launch
New Call Plan
83 FTE’s
Organic Reps
CSO promotion starts
30 FTE’s
CSO Reps
Sales Force
Size
P1: MINI
P2: Core Brands
40 FTE’s
Organic Reps
P1: MINI
P2: Core Brands
P1: Nicomide (Dermatologists)
1. Core Brands include PRENATE DHA®, ELITE®, and ESSENTIAL®
Q4
Q1
Q2
Q3
Q4
Falessa new product launch
New Call Plan
100
Organic Reps
P1: Falessa
P2: MINI
P3: FeRiva
Avion Opportunistic Business Development
•
Acquire products from larger pharmaceutical companies that fit the core strategy – Women’s Health /
Dermatology
–
Currently reviewing a suite of WH products from a larger company
•
HRT
•
Nutritionals
•
Hematinic
•
Other
•
Validate and spearhead launches that will support unmet needs in women’s health market – i.e.
probiotics and breastfeeding
•
Exclusive license of unique calcium API with patent and NDI approval, will be core API for new Prenate®
brands (Formical®)
•
Exclusive license of unique iron API with patent and NDI approval, will be core for API for new Prenate
brands (Albion hematinic portfolio)
•
In-license / acquire products from development companies both US / Ex US
•
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Injectable Iron
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Advanced oral iron
Develop our own NDA products
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OC combo NDA
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Bacterial Vaginosis NDA
Portfolio and Development Strategy
For Every Step There is a Prenate ® – Continuum of Care for Women
Intra-conception
IVF
Hormone Replacement
Endometriosis
Preconception
Pregnancy
Post Natal
PreConception
Perio-Menopausal
The Prenate Continuum of Care – Leveraging the prestige of the
Prenate brand across the lifespan of our patients – from pre-pregnancy to
post-menopausal. “We were there for you then; we’re there for you now”.
Post Menopausal/
Osteoporosis
Avion Product Development
Avion pursues an integrated short-term / long-term approach to product
development designed to shorten commercialization cycles, enhance
overall portfolio value, and build Avion’s market presence and influence
in Women’s Health, Hematinic and Dermatology.
•
•
Short Term Criteria
–
Low barriers to entry
–
Leverage exisiting sales
–
Unique, protected
–
Building block in our continuum strategy
Long Term Criteria
–
NDAs
–
Unique high impact products
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Significant clinical application
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Narrow therapeutic indication
–
Compliments our continuum of care
–
Builds on our legacy and expertise
Avion Product Launches for 2013 & 2014
Product Category
Product Launch
Market Size
Prenate Mini
Q2-12
$160mm
Hematinic – OB (FeRiva)
Q1-13
$250mm
Prenate Chewable
Q1-13
$155mm
Prenate AM – Morning Sickness
Q1-13
$195mm
Prenate Enhance – Advanced
Formulation
Q2-14
$155mm
Prenate Restore Post Pregnancy
(Breastfeeding)
Q3-14
$195mm
Falessa - (oral contraceptive)
Q2-14
$3.8B
Prenate® Franchise Historical Highlights
•
Previously #1 prescribed prenatal vitamin in U.S.
•
1.8mm prenatal prescriptions generated in ‘09
•
Most widely recognized and trusted brand in
prescription nutrition for women during pregnancy
•
Three Original Prenate® brands
– Prenate® DHA
– Prenate® Essential
– Prenate® Elite
Prenate® Product Launch Highlights
•
New Product Launch – Prenate® Mini June 2012
–
Prenate® Mini now the “fastest-growing” PNV in the entire branded and generic PNV
category (IMS NPA Data Dec. 7, 2012)
•
Added Prenate® Chewable - May 2013
•
Introduced Prenate® AM - August 2013
•
Launched Prenate® Enhance & Prenate® Restore – November 2013. The
most advanced Prenatal and the first Postpartum Supplement with
Probiotics
Avion Dermatology
Avion Dermatology Portfolio
•
Acquisition of Nicomide in 2011
– Generic competition removed providing exclusivity
– Field promotion August 2012
•
Nicomide® - Allows HCPs to address one component of acne that
is currently not being treated with some of the other products
available – the inflammation.
•
Nicomide – Natural supplement that works on mediating the
outward signs of inflammation – redness and swelling, as well as
the internal signs by preventing free fatty acids from forming can
cause of inflammation
Avion Portfolio
NEW!!
NEW!!
NEW!!
NEW!!
Avion Long-Term Pipeline Development Summary
Product
Indication
Phase
Projected
NDA
Approval
Market
Size
Oral Contraceptive Fe
Oral contraception
Phase 2
Q2 - 2016
$3.8B
Oral Contraceptive
Folic Acid
Oral contraception
Phase 2
Q4 – 2016
$3.8B
Oral Contraceptive
FA – Fe
Oral contraception
Phase 1
Q2 - 2017
$3.8B
Vaginal Delivery
Estrogen/Testosterone
Vaginal atrophy
Pre-clinical
Q1 – 2018
$250M
Combination BV/VVC
QD Dose Product
Vaginal infection
Pre-clinical
Q2 - 2017
$200M
Boric Acid 4.5% In a
Bioadhesive Vaginal
base
Vaginal infection
Phase 2
Q4 - 2016
$150M
Pregnancy and PostPartum Hemorrhoid &
Vaginal Varicosity Care
Post and Pregnancy
related hemorrhoids
Phase 1
Q4 - 2017
$225M
Reference Market Size – approximation IMS data source
Avion – An Integrated Growth Strategy
Avion NDAs
Avion Acquisitions
Avion Refomulations
$
•
Short-Term Revenue Generation
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–
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Market Participation
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Avion acquisitions on reformulations with patented API
Avion Nutritionals
Avion Sales Force Built on Advanced Nutritionals
Hematology, Oncology, Nephrology, GI
Innovation Drives Long Term Success
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–
Avion NDAs
Avion Strategic Acquisitions
Right now, Avion has received 5 American Business (“Stevie”) Awards
•
•
•
•
Prenate® Mini Marketing Campaign
Category: Marketing Campaign of the
Year – Pharmaceuticals
Prenate® Mini Brand Experience
Category: Brand Experience of the Year
Prenate Mini - Smallest Rx Prenatal
Vitamin
Category: Best New Product Of the Year
Prenate Mini – Making it easy to take
Consumer Marketing Campaign of the
Year
Avion Nominated for HDMA Diana Award 2014 – Manufacturer of the Year
A Commitment to Healthcare, Leadership and Innovation
HDMA’s Distribution Industry Award for Notable Achievements in Healthcare
(DIANA) has been the industry’s most recognized symbol of excellence since
1959. The award honors pharmaceutical and consumer product manufacturer
members that set the standard of excellence in new product introductions and
product promotions as well as build stronger business practices with HDMA
distributor members.
The DIANA Best Overall Manufacturer Award is a
distributor-driven nomination process. HDMA distributor members are asked
to nominate their top five manufacturer partners in each of the six categories.
HDMA will honor leading manufacturers with the DIANA on Monday, June
2, 2014, at its annual Business and Leadership Conference in Phoenix. The
awards will recognize HDMA associate manufacturer member companies
that strengthen their business partnerships with HDMA distributor members
by developing innovative, results-oriented business practices to bolster trade
relations and benefit the entire healthcare supply chain.
Nominations for these awards are submitted by HDMA’s distributor members
through Friday, March 28, 2014. DIANA winners join an elite circle of past
recipients who serve as models for leadership and innovation in the healthcare
marketplace and become part of the tradition of excellence that the DIANA has
fostered for more than a 50 years.
Join HDMA to celebrate and honor excellence in the healthcare supply chain!
Avion Pharmaceuticals is uniquely positioned to leverage our product
development innovation and recent success with the Prenate®
Franchise to expand our therapeutic focus further into “other”
Women’s Health therapeutic categories while also leveraging our
product development innovation and acquisition strategy to leverage
our Specialty Pharmaceutical market expertise to further expand into
the hematology, oncology nephrology, and gastroenterology
therapeutic categories.
Avion Pharmaceuticals is well positioned for continued and sustained
growth through a proven portfolio development strategy and
experienced commercial leadership team with a proven track record in
building previously successful Specialty Pharmaceutical companies.
Summary