EX-99.2 3 d867874dex992.htm EX-99.2 EX-99.2
Innovative Solutions for Global Health
Corporate Presentation
Exhibit 99.2


1
Safe Harbor Statements
This
presentation
(“Presentation”)
contains
“forward-looking”
statements
within
the
meaning
of
the
Private
Securities
Litigation Reform Act of 1995 that are based on our management’s beliefs and assumptions and on information currently
available to management. These forward-looking statements include, among others, statements regarding the timing of our
anticipated
clinical
trials
and
results
for
PF582,
PF530
and
our
other
product
candidates,
expectations
with
regard
to
future
milestone and royalty payments from our collaboration with Hospira, potential market opportunities for PF582, PF530 and
our other product candidates, the expected patent expiration timelines for Lucentis, Betaseron, and other branded reference
drugs, the potential outcomes of our discussions with governmental regulatory agencies, our anticipated commercialization
strategy,
and
our
expected
use
of
our
cash,
cash
equivalents
and
short-term
investments.
Forward-looking
statements
are
typically
identified
by
words
like
“believe,”
“anticipate,”
“could,”
“should,”
“estimate,”
“expect,”
“intend,”
“plan,”
“project,”
“will,”
“forecast,”
“budget,”
“pro forma,”
and similar terms. Factors that could cause the Company's results to differ
materially from those expressed in forward looking statements include, without limitation, our need for additional funds to
support
our
operations;
our
success
being
dependent
on
PF582
and
PF530;
our
reliance
on
our
collaboration
partners’
performance over which we do not have control; failure to achieve favorable results in later clinical trials for PF582 and
PF530
or
receive
regulatory
approval;
delays
in
our
clinical
trials
or
in
enrollment
of
patients
in
our
clinical
trials;
failure
to
market PF582 or PF530 due to the existence of intellectual property protection owned or controlled by a third party and
directed to PF582 or PF530; PF582 and PF530 may cause serious adverse side effects or have properties that delay or
prevent regulatory approval or limit their commercial profile; if approved, risks associated with market acceptance, including
pricing and reimbursement; and our ability to enforce our intellectual property rights. Forward-looking statements represent
our management’s beliefs and assumptions only as of February 10, 2015. You should read our Quarterly Report on Form 10-
Q for the quarter ended September 30, 2014 and our subsequent periodic reports, including our Form 10-K for the year ended
December
31,
2014,
which
is
expected
to
be
filed
with
the
SEC
in
March
of
2015,
including
the
Risk
Factors
set
forth
therein,
completely and with the understanding that our actual future results may be materially different from what we expect. Except
as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons
why actual results could differ materially from those anticipated in the forward-looking statements, even if new information
becomes available in the future.
All patent expiry dates provided in this Presentation are estimated based on publically available information as of the July 23,
2014 and speak only as of that date.


2
Investment Highlights
Biosimilar developer with patented protein production and
analytics platform
Validation through            industrial experience and collaborations with big
pharma
12 products in development pipeline
8 biosimilars and 1 peptide generic
3 vaccine candidates
Lead product PF582 –
biosimilar candidate to Lucentis
®
Manufacturing and cost advantages from Pfenex Expression Technology
Large Lucentis market opportunity; $4.3B in 2013 sales ($6.7B anti-VEGF segment)
Limited competition
Local administration
Visual Acuity clinical trial endpoints
Approximately 100 person sales force to address focused retinal specialist market
Up to $342 million PF582 collaboration with Hospira
Further validates Pfenex’s product development strength and capability as pipeline of
biosimilar candidates continue to advance


3
Pfenex Pipeline
*PF582 in collaboration with Hospira


4
Why Biosimilars Now?
Market opportunity is significant
Patent cliff: by 2020, biologic products representing approximately $100 billion of aggregate
2013 product sales will have become available globally
Favorable Pricing: 2010 discounts on certain biosimilars in EU member states ranged
between 8% and 23% compared to the reference products
Global cost containment favors utilization of biosimilars
Increasing mandate for lower drug costs by governments and private payors
Strong uptake and growth of biosimilars: approximately 30%-40% volume penetration in EU5
Regulatory pathways (abbreviated) for biosimilars are defined
EU: CHMP 437/04 published 2005
First approval in 2006; approximately 20 approvals
US: 351(k) pathway established in 2010; Five draft guidance documents
4th
guidance:
Comparative
analytical
similarity
data
submission
prior
to
being
granted
a
Biosimilar
Initial
Advisory Meeting
At least 4 biosimilar candidates have been submitted for approval under 351(k) in the U.S.
Sandoz’s biosimiilar candidate to filgrastim underwent  review at FDA Advisory Committee meeting held in
January 2015 and the result was a unanimous 14-0 vote for approval.
Strong barriers to entry
Quality, long timeline to create production strain, process development and minimizing COGS
are all challenges for biosimilars creating both hurdles and opportunities
Bioanalytical characterization and attention to COGS are key factors to compete


5
"Do Loop 1"
"Good Enough"
Inadequate
Some
Production
Handful of Conditions
Refine conditions
Discovery
PC/1
Early Stage
Late Stage
"Do Loop 2"
DEVELOPMENT
-
Pfenex
Expression
Technology
Current Protein Production Process:
Handful of Experiments –
Trial & Error
Pfenex Platform: Thousands of Parallel Experiments
Faster, Scalable, Higher Quality, Lower Cost
Problem:
Traditional
techniques
=
trial
and
error
protein
strain
selection
Solution: Pfenex Expression Technology
Current Duration on Average: 1 Year Process!
Process Duration:  ~ 9 Weeks
Thousands of Expression Strains Cultured in Parallel
High-Throughput Analytical Quality, Titer & Function
Production Strain Down-Selection
48 Parallel Micro Scale Fermentations
High-Throughput Analytical
Quality, titer & Function
16 Parallel 1L Fermentations
High-Throughput Analytical
Quality, titer & Function
-


6
-
Optimizing the Expression Universe
Let the biology dictate the
best conditions
High yield
High quality
Thus, low-cost production
Speed to solution encompasses taking guesswork out of the protein
production paradigm
Pfenex
Expression
Technology
has
proven
track
record
of
rapidly
improving expression –
especially for “difficult”
to produce proteins
>80% success rate with proteins that have failed in other expression systems
11 of top 15 top biopharmaceutical companies have collaborated with Pfenex
Platform/capabilities highly applicable to biosimilars
Traditional:
Trial and
Error
Goal:
High Quality, High
Titer


7
Bioanalytical expertise creates robust characterization
FDA 351(k) and CHMP 437/04 both heavily emphasize
bioanalytics
Extensive in-house analytical capabilities
Structure
Folding
Activity
Purity
Yield
Characterization is Essential to Accessing
Biosimilar Pathways


8
PF582: Biosimilar to Lucentis (ranibizumab)
PF582 has the potential to disrupt the growing retinal
disease market
Branded Lucentis: $4.3 billion in 2013
Lucentis label extrapolation (including DME, RVO) enables broad
access
We believe PF582 is the most advanced Lucentis biosimilar
in development
Pfenex was granted a Biosimilar Initial Advisory Meeting
(January 2014)
FDA indicated that our analytical data appear acceptable to support
the development of PF582 as a biosimilar to Lucentis
Clear guidance from FDA for global regulatory approach
Developing according to 351(k) pathway
PF582 production process already at launch scale
Completed enrolling Phase 1b/2a trial


9
PF582: Hospira Collaboration
$342 million in combined upfront and potential milestone
payments
$51 million upfront payment and $291 m in potential milestone
payments
Tiered double digit royalties on net sales
Split phase 3 clinical trial costs
Pfenex costs capped at $20 million, $10 million of that deferred
until
commercialization
Hospira responsible for manufacturing, commercialization and
litigation
Collaboration governed by Executive Steering Committee with
equal representation from each company
Agreement allows for additional potential product collaborations
Further validates Pfenex biosimilar product development strength
and capability
* Subject to HSR Approval


10
Country IP Status
Current Open
Q2 2018
Q2 2020
Jan 2022
Cumulative
2013 Sales (IMS Health)
$65MM
$471MM
$2B
$1.7B
$4.2B
PF582 Launches to Follow IP Expiry Roadmap


11
PF708: Generic to Forteo
®
Forteo (teriparatide) indicated for treatment of high fracture
risk osteoporosis
Reference product made by E. coli fermentation
2013 sales $1.25 billion
Generic regulatory approval pathway for PF708
Latest to expire Orange Book-listed Forteo patent in 2019
Pfenex has achieved high titer protein production; low cost
of goods
Bioequivalence study expected to initiate in 2H15
First to file potential, confers 180 day exclusivity


12
Strides Joint Venture (JV)
Strides collaboration: cost effective progression
of six biosimilars in Pfenex pipeline
Global commercialization of partnered products
Terms provide efficient product development
progression
Pfenex responsible for creating protein production engine, process
development and analytical package
Strides and Pfenex share in development costs


13
PF530: Biosimilar to Betaseron
®
Betaseron (interferon beta-1b):  indicated to reduce relapse
number in multiple sclerosis patients
Sales of $1.4 billion in 2013
We believe PF530 is the most advanced Betaseron
biosimilar in global development
Phase 1 trial PF530 v. Betaseron:
expected to initiate in
early 2015
Trial funded by Strides
Data expected in 2H15
Phase 3 trial expected to commence 2016


14
Vaccine Strategy Focused on Value
Creation –
Fully Funded by US Government
Anthrax (rPA):
Malaria:
>$45MM in awards from BARDA and
NIH (NIAID) for anthrax vaccine (3
programs)
Target market is the first responders
and strategic national stockpile (SNS)
Vaccine procurement historically
approximately
$250MM annually; current
pricing is approximately $27/dose
US Government has articulated SNS to be
75MM doses; never filled due to lack of
capability of incumbent technology
Potential procurement contract if
within 10 years of FDA approval
IND filed
Phase 1a initiation in 2H15
>$8.5MM in awards from NIH/NIAID for
the development of a better malaria
vaccine
Proteins which either have been unavailable
(couldn’t be made) (circumsporozoite protein,
CSP) or have not been made in sufficient
quantities/quality (Rh5)
Target market includes military,
governments, travelers to endemic
regions
Military market ~12.5MM doses  by 2025
Traveler’s market estimated between 1.7MM
and 3.3MM doses by 2025
No current vaccine available
Phase 1 initiation 2015


15
IP Protects Platform and Products
Platform and Toolbox
10 patent families
80 issued/allowed
(8 U.S., 34 in EPO countries)
Products
7 patent families
10 issued/allowed
(3 U.S., 3 in EPO)
Promoters
Secretion Leaders
Strain Engineering
and Screening
Auxotrophic
Markers
Expression
Plasmids
Biosimilar
Production
Microbial Toxin
Production
Protein Expression
Vaccine Antigen
Production
Status of portfolio, including the number of issued/allowed patents and geographic regions are as of December 31, 2014.


16
Selected Upcoming Milestones
Expected Event
Timing
PF582 -
Ranibizumab
biosimilar (Lucentis
®
)
Phase 1b/2a trial completion
1Q15
Manufacturing/technology transfer to Hospira
2015
Initiate Phase 3 equivalence trial of PF582 vs. Lucentis in wet AMD
2016
PF708 -
Teriparitide generic
(Forteo
®
)
Initiate ANDA-enabling bioequivalence trial of PF708 vs. Forteo
2H15
PF530 -
Interferon beta-1b
biosimilar
(Betaseron
®
)
Initiate Phase 1 trial of PF530
1Q15
Phase 1 data of PF530
2H15
Recombinant anthrax
vaccine
Initiate Phase 1a of recombinant anthrax vaccine
2015
Recombinant malaria
vaccine
Initiate Phase 1 of recombinant malaria vaccine
2015


17
Investment Highlights
Biosimilar developer with patented protein production and
analytics platform
Validation through            industrial experience and collaborations with big
pharma
12 products in development pipeline
8 biosimilars and 1 peptide generic
3 vaccine candidates
Lead product PF582 –
biosimilar candidate to Lucentis
®
Manufacturing and cost advantages from Pfenex Expression Technology
Large Lucentis market opportunity; $4.3B in 2013 sales
Limited competition
Local administration
Visual Acuity clinical trial endpoints
Approximately 100 person sales force to address focused retinal specialist market
Up to $342 million PF582 collaboration with Hospira
Further validates Pfenex’s product development strength and capability as we continue to
advance our pipeline of biosimilar candidates


18
Appendix


19
Overview of US/EU Biosimilar Regulation
US Biosimilar Regulatory Path
EU Biosimilar Regulatory Path
351(k) U.S. biosimilar approval pathway established in
2010
Five FDA guidance documents provide additional
clarity on path
Benefits of 351(k) = abbreviated development
Bioanalytical assessment is a key element of
biosimilar market authorization
Defines degree of similarity and whether 351(k)
pathway is available for the proposed product
FDA Guidance adds clarity regarding pathway
timing/requirements
Similar to EU process: totality of evidence
Specific delineation and outcomes of meetings with the
FDA in fourth guidance document
Unlike generics, patent disputes do not trigger 30
month delay; FDA review of 351(k) submission may
continue during any litigation
Additional interchangeability guidance expected in
2014
CHMP/437/04 biosimilar approval pathway established
in 2005
Biosimilar guidance on quality as well as non-clinical
and clinical issues, including immunogenicity
Additional product-class specific annex guidelines
issued including:
EMA approval based on totality of evidence similar to
FDA 351(k) pathway
First biosimilar approved in 2006 (Omnitrope)
As of 2014 20 biosimilar products have been approved
by EMA
Price discount between 8% and 23% of innovator in for
biosimilars 2010
Avg. 71% filgrastim biosimilar penetrance in EU
>50% EPO biosimilar penetrance in Germany
>90% EPO and filgrastim biosimilar penetrance in
Hungary
Australia, Canada, Japan, South Korea and South
Africa have adopted a biosimilar path very similar or
idem quot to the EU
Abbreviated pathway with limited preclinical and
clinical studies, with reference to innovator product
Wang, J. and Chow, S. On the Regulatory Approval Pathway of Biosimilar Products. Pharmaceuticals, 5 (4). April 2012, pp. 353-368.
Alliance
for
Safe
Biologic
Medicines.
Alliance
for
Safe
Biologic
Medicines:
Information
Center.
Alliance
for
Safe
Biologic
Medicines.
http://www.safebiologics.org/info-center.php.


20
The Pfenex Toolbox
Thousands of unique components can be seamlessly integrated to enable rapid strain engineering for optimal protein
production
accelerating
proof
of
concept
product
development
and
long
term
cost
of
goods
advantage