Pfenex (PFNX) 8-K Pfenex and Hospira Announce Collaboration to Develop

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