Pfenex Inc

Pfenex Inc.

Fiscal 2016 Annual Report

March 30, 2017

Dear Fellow Stockholders:

In 2016, Pfenex continued its momentum by further advancing our programs in product development. We made
steady progress advancing our broad pipeline of biosimilar therapeutic candidates, therapeutic equivalent product
candidates, and vaccine candidates, regained full rights to PF582 (biosimilar candidate to Lucentis®) and
completed a worldwide license and option agreement with Jazz Pharmaceuticals (Jazz) that further demonstrates
the versatility of our production platform. In addition to the progress within our development programs, we
continued to strengthen the organization with the formation of our Scientific Advisory Board (SAB) that will
provide technical guidance as we advance toward product commercialization.

This year, we saw increased clarity in the biosimilars market with the release of several important guidance
documents that have further articulated the US Food & Drug Administration’s (FDA) current thinking with
regard to the biosimilar approval process in the United States. We also saw continued focus on domestic medical
countermeasure infrastructure, as affirmed by our ongoing collaboration with the Biomedical Advanced Research
and Development Authority (BARDA).

Our Product Candidates

Our product development programs continue to progress. In May, we announced positive top-line bioequivalence
data in healthy subjects for PF708, our therapeutic equivalent candidate to Forteo®. In December, we initiated a
pivotal clinical study for PF708, which will include an immunogenicity and pharmacokinetic assessment in
osteoporosis patients. In July, we entered into a collaboration with Jazz on multiple hematology/oncology
product candidates which includes an option for Jazz to negotiate a license for an Oncaspar® biosimilar
candidate from Pfenex. Pfenex received upfront and option payments totaling $15 million and may be eligible to
receive additional payments of up to $166 million based on the achievement of certain development, regulatory,
and sales-related milestones, including up to $41 million for certain non-sales-related milestones. Pfenex may
also be eligible to receive tiered royalties on worldwide sales of any products resulting from the collaboration. In
August, we announced positive results from the Phase 1/2 clinical study for PF582, our biosimilar candidate to
Lucentis, and simultaneously regained full rights to the product. We continue to explore strategic options for the
PF582 product. In December we received regulatory feedback for PF529, our biosimilar candidate to Neulasta®,
and pursuant to that feedback we are currently evaluating a development plan for the product.

Finally, we continue to work closely with BARDA on Px563L, our recombinant protective antigen (rPA) anthrax
vaccine candidate. In August we announced positive immunogenicity and safety data from the Day 70 analysis of
Px563L in a Phase 1 clinical study. The results demonstrate tolerability and significant immunogenicity after
only two doses of Px563L. Subsequent to the communication of the promising Phase 1 clinical data and the
BARDA In Process Review (IPR) meeting, BARDA has authorized the opening of additional phases of the
development contract in our $143.5 million advanced development contract in support of process optimization
for the antigen and adjuvant. Our partnership with BARDA and ongoing communication with Congressional
offices has emphasized the relevance of this initiative for US medical countermeasure support.

2016 Employee Additions and Scientific Advisory Board Development

In 2016, we added experienced professionals to the management team, including Steven Sandoval as our Chief
Manufacturing Officer. Mr. Sandoval has over 25 years of commercial biopharmaceutical engineering and
operations experience, specializing in commercial operations, facility design and licensure of large-scale
biopharmaceutical commercial manufacturing facilities. He has extensive knowledge of cGMP
biopharmaceutical engineering as well as significant first-hand experience preparing for and interfacing with the
FDA and other global regulatory agencies during pre-licensure and biennial inspections of commercial cGMP
biopharmaceutical manufacturing facilities. We also added Mayda Mercado as Vice President of Quality
Assurance. Ms. Mercado is a quality and compliance leader with over 25 years of progressive leadership in the
biopharmaceutical/pharmaceutical and health care industry, bringing a diverse and broad experience to the team.

In October, we announced the establishment of our inaugural Scientific Advisory Board (SAB) to assist Pfenex
as we navigate process development and analytical similarity and move closer to product commercialization.
SAB members include Greg Blank, Ph.D., a recognized global leader in bioprocess development; Matthew S.
Croughan, Ph.D., an expert in biopharmaceutical, cell therapy, and biofuels process development; and Dennis
Fenton, Ph.D., an industry pioneer, with over three decades of experience in biotechnology. Together, the vast
industry experience of these three individuals will be invaluable as we advance our product pipeline.

Biosimilar Industry Overview

In 2016, the advancement of biosimilars in the US market was significant and the momentum was marked by
additional biosimilar product approvals and further regulatory guidance from the FDA. We continued to see US
approvals for biosimilars, with three approved in 2016 and one additional biosimilar approved in early 2015.
There are currently at least 66 programs in the Biosimilars Biologic Product Development (BPD) program at the
FDA. The increased scrutiny on drug pricing in the United States has highlighted the potential of biosimilars to
be considered part of the solution.

Importantly, the FDA progressed the conversation within biosimilars, publishing final guidance on labeling in
March, an important step in framing and paving the pathway for biosimilars marketing moving forward. We also
saw additional clarity from the courts with the decision by the US Court of Appeals for the Federal Circuit
decision in Amgen v. Sandoz, which determined that the decision of a biosimilar developer to engage in the
patent dance with a reference product is optional, but that a biosimilar candidate must wait for FDA approval
prior to providing 180-day market notification. In early 2017, the US Supreme Court agreed to hear the Amgen v.
Sandoz case centering on these two particular provisions of the Biologics Price Competition and Innovation Act
(BPCIA).

As the first biosimilars prepared to enter the US market, 2016 saw several insurance providers move toward
adoption of biosimilars onto formularies, and in certain cases excluding the branded product in favor of its
biosimilar. One payer has even gone so far as to establish a biosimilars-only tier providing lower out of pocket
costs to patients and thus fostering biosimilar uptake.

Other key developments in the market included finalization of guidance from the Center for Medicaid and
Medicare Services (CMS) on J-codes, which affirmed that all biosimilars of a reference product would share a
J-code that was separate from the reference product J-code. The FDA also released guidance for biosimilars
naming.

Moving forward, we expect to receive clarity and advancement on several important concepts in 2017.
Specifically, we anticipate final guidance from the FDA on interchangeability as well as an ultimate decision on
the patent dance and market exclusivity provisions from the Supreme Court. As well, we expect to see additional
clarity around the Trump Administration’s impact on agencies and regulations, specifically as they relate to
biosimilars market development.

We will continue to work closely with our industry and agency counterparts to advance understanding and
education of biosimilars, encouraging market uptake and driving toward greater patient access to medicines
through biosimilars approval and adoption.

Medical Countermeasures Overview

At the end of last year we saw continued support for medical countermeasures (MCMs) in Congress through the
passage of the 21st Century Cures legislation. This important piece of legislation includes a specific incentive for
developers of MCM’s to identified threats in the form of a Priority Review Voucher (PRV). The PRV can be
applied to any other product requiring FDA approval; it provides a marketing application priority review, where
FDA’s goal is to review such application within 6 months, instead of the traditional 10-month review period. The
PRV can also be sold to another company, thereby providing an important financial incentive to MCM
developers. In 2017, we look toward Congress for implementation of this legislation, including the appropriation

of funds to support BARDA, as well as providing resources to the BioShield Special Reserve Fund and the
Strategic National Stockpile. These efforts could provide advanced funding for important programs such as
Pfenex’s anthrax vaccine program. Pfenex will continue to monitor and support these important policies and
work with policymakers to provide medical countermeasures having the potential to protect the American public
and our allies.

2017 and beyond

As we move into 2017, our strategy will focus on execution of our lead product development programs. We will
be nimble in our response to evolving policies both domestically and globally, and will leverage our unique
platform and approach to drive cost-effective development and production of biosimilar and medical
countermeasure products. We continue to drive quality execution as the expectation of all stockholders and
maintain our focus on educating the market as to the impact and benefit of biosimilars. We are focused on our
commitment to maintain our competitive advantage by developing quality products efficiently and effectively.
And, we will remain steadfast in our advocacy for the biosimilar and biodefense industries to be able to increase
patient access to important therapies and provide the American public safety against certain biological threats.

I thank you for the confidence to which you have entrusted us at Pfenex.

Sincerely,

Patrick K. Lucy
Interim Chief Executive Officer, President, and Secretary, and Chief Business Officer

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-K

(Mark One)
È ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2016
or

‘ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

For the transition period from

to

Commission file number: 001-36540

Pfenex Inc.

(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of
incorporation or organization)

27-1356759
(I.R.S. Employer
Identification Number)

10790 Roselle Street
San Diego, California 92121
(Address of principal executive offices, including zip code)
858.352.4400
(Registrant’s telephone number, including area code)

Common Stock, par value $0.001 per share

NYSE MKT LLC

Securities registered pursuant to Section 12(b) of the Act:

(Title of each class)

(Name of each exchange on which registered)

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act: Yes ‘ No È
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act: Yes ‘ No È
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934

during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes È No ‘

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File
required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter
period that the registrant was required to submit and post such files). Yes È No ‘

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and

will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. È

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.

See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ‘
Non-accelerated filer ‘ (Do not check if a smaller reporting company)

È
Accelerated filer
Smaller reporting company ‘

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ‘ No È
The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant, based on the closing sale price of the
Registrant’s common stock on the last business day of its most recently completed second fiscal quarter, as reported on NYSE MKT, was approximately
$169.3 million. Shares of common stock held by each executive officer and director and by each other person who may be deemed to be an affiliate of the
Registrant, have been excluded from this computation. The determination of affiliate status for this purpose is not necessarily a conclusive determination for
other purposes.

As of March 6, 2017, there were 23,372,791 shares of the registrant’s common stock, $0.001 par value, outstanding.

DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s Proxy Statement for its Annual Meeting of Stockholders are incorporated by reference in Part III of this Annual Report on

Form 10-K where indicated. Such Proxy Statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year
ended December 31, 2016.

Pfenex Inc.

Annual Report on Form 10-K

For the Fiscal Year Ended December 31, 2016

TABLE OF CONTENTS

PART I

Item 1. Business
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 1A. Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 1B. Unresolved Staff Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 2.
Item 3.
Legal Proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 4. Mine Safety Disclosures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART II

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of

Equity Securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 6.
Selected Financial Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations . . . . .
Item 7A. Quantitative and Qualitative Disclosures about Market Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Financial Statements and Supplementary Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 8.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure . . . . .
Item 9A. Controls and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 9B. Other Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART III

Item 10. Directors, Executive Officers and Corporate Governance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 11. Executive Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder

Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 13. Certain Relationships and Related Transactions and Director Independence . . . . . . . . . . . . . . . . .
Item 14. Principal Accountant Fees and Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART IV

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Item 15. Exhibits and Financial Statement Schedules
Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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As used in this Annual Report on Form 10-K, the terms “the Company,” “we,” “us” and “our” refer to

Pfenex Inc. and its subsidiaries, unless the context indicates otherwise.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended,
which are subject to the “safe harbor” created thereunder and which involve substantial risks and uncertainties.
Forward-looking statements generally relate to future events or our future financial or operating performance. In
some cases, you can identify forward-looking statements because they contain words such as “may,” “will,”
“should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar terms or
expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements contained in
this Annual Report on Form 10-K include, but are not limited to, statements about:

•

•

our and our collaboration partners’ ability to enroll patients in our clinical studies at the pace that we
project;

our expectations regarding the timing and the success of the design of the clinical trials and planned
clinical trials of PF708, PF582 and our other product candidates, and reporting results from same;

• whether the results of our and our potential collaboration partners’ trials will be sufficient to support

domestic or global regulatory approvals for PF708 and PF582;

•

•

•

•

•

•

•

•

•

•

•

•

•

our and our collaboration partners’ ability to obtain and maintain regulatory approval of PF708, PF582
or our future product candidates, and the timing of such regulatory approvals;

our reliance on third parties to conduct clinical studies;

our reliance on third-party contract manufacturers to manufacture and supply our product candidates
for us;

the benefits of the use of PF708, PF582 or any of our other product candidates;

the rate and degree of market acceptance of PF708 and PF582 or any of our other product candidates;

regulatory developments in the United States and foreign countries;

our expectations regarding government and third-party payor coverage and reimbursement;

our ability to manufacture PF708, PF582 and our other product candidates in conformity with
regulatory requirements and to scale up manufacturing of PF708, PF582 and our other product
candidates to commercial scale;

our ability to successfully build a specialty sales force, or collaborate with third-party distributors, to
commercialize our product candidates;

our ability to compete with companies currently producing the reference products, including Forteo and
Lucentis;

our reliance on our collaboration partners’ performance over which we do not have control;

our ability to retain and recruit key personnel, including development of a sales and marketing
function;

our ability to obtain and maintain intellectual property protection for PF708, PF582 or any future
product candidates;

-ii-

•

•

•

•

•

•

•

•

•

•

our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or
ability to obtain additional financing;

the sufficiency of our cash and cash equivalents and cash generated from operations to meet our
working capital and capital expenditure needs;

our expectations regarding the market size, size of patient populations, and growth potential for our
product candidates, if approved for commercial use;

our estimates of the expected patent expiration timelines for Forteo, Lucentis and other branded
reference biologics;

our expectations regarding the time during which we will be an emerging growth company under the
Jumpstart Our Business Startups Act;

our ability to develop new products and product candidates;

our ability to successfully establish and successfully maintain appropriate collaborations and derive
significant revenue from those collaborations;

our ability to successfully implement our planned remediation efforts with respect to our internal
controls over financial reporting;

our financial performance; and

developments and projections relating to our competitors and our industry.

We caution you that the foregoing list may not contain all of the forward-looking statements made in this

Annual Report on Form 10-K.

You should not rely upon forward-looking statements as predictions of future events. We have based the
forward-looking statements contained in this Annual Report on Form 10-K primarily on our current expectations
and projections about future events and trends that we believe may affect our business, financial condition,
results of operations, and prospects. The outcome of the events described in these forward-looking statements is
subject to risks, uncertainties, and other factors described in the section titled “Risk Factors” and elsewhere in
this Annual Report on Form 10-K. Moreover, we operate in a very competitive and rapidly changing
environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all
risks and uncertainties that could have an impact on the forward-looking statements contained in this Annual
Report on Form 10-K. We cannot assure you that the results, events, and circumstances reflected in the forward-
looking statements will be achieved or occur, and actual results, events, or circumstances could differ materially
from those described in the forward-looking statements.

The forward-looking statements made in this Annual Report on Form 10-K are based on information
available to us on the date of this Annual Report on Form 10-K. We undertake no obligation to update any
forward-looking statements made in this Annual Report on Form 10-K to reflect events or circumstances after the
date of this Annual Report on Form 10-K or to reflect new information or the occurrence of unanticipated events,
except as required by law. We may not actually achieve the plans, intentions, or expectations disclosed in our
forward-looking statements and you should not place undue reliance on our forward-looking statements. Our
forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions,
joint ventures, or investments we may make.

This Annual Report on Form 10-K also contains estimates, projections and other information concerning our

industry, our business, and the markets for certain diseases, including data regarding the estimated size of those
markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates,
forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual
events or circumstances may differ materially from events and circumstances reflected in this information.

-iii-

Unless otherwise expressly stated, we obtained this industry, business, market, and other data from reports,
research surveys, studies, and similar data prepared by market research firms and other third parties, industry,
medical and general publications, government data, and similar sources.

Pfe¯nex™ and Pfe¯nex Expression Technology® are our primary registered trademarks. This Annual Report

on Form 10-K contains these trademarks and some of our other trademarks, trade names and service marks. Each
trademark, trade name or service mark of any other company appearing in this Annual Report on Form 10-K
belongs to its respective holder.

-iv-

Item 1.

Business

Overview

PART I

We are a clinical-stage biotechnology company engaged in the development of biosimilar and therapeutic

equivalent products and other high-value and difficult-to-manufacture proteins. We leverage our protein
production platform, Pfe¯nex Expression Technology®, to produce complex proteins with higher accuracy and
greater degree of protein purity, as well as speed and cost advantages. We use this technology to produce
biosimilar candidates, therapeutic equivalent product candidates, as well as vaccine candidates. It is our goal to
leverage our patented technology and our team’s expertise in bioanalytical characterization to become a leading
protein therapeutics company.

We are currently focused on several product candidates, however our two lead candidates are PF708, a

therapeutic equivalent candidate to Forteo®, and PF582, a biosimilar candidate to Lucentis®.

Product Candidates

The following table summarizes certain information about our lead product candidates:

Product Candidate

Branded
Reference
Drug

Collaboration
Partner

Indication

Biosimilars and Therapeutic Equivalents
PF708 – Teriparatide . . . . . . . . . . . . . . . Forteo Wholly-Owned Osteoporosis
PF582 – Ranibizumab . . . . . . . . . . . . . . . Lucentis Wholly-Owned Macular edema or choroidal

Novel Vaccines
Px563L – rPA based anthrax vaccine . . N/A

neovascularization conditions

U.S. Government

Anthrax post-exposure prophylaxis

Funded

PF708 – Forteo

PF708 is a product candidate that is being developed as a therapeutic equivalent to Forteo (teriparatide),

marketed by Eli Lilly for the treatment of osteoporosis patients at high risk of fracture. Forteo achieved
approximately $1.4 billion in global product sales in 2015. The PF708 bioequivalence study, conducted in 70
healthy subjects, was completed in the second quarter of 2016 and met its primary objectives. The 90%
confidence intervals of the area-under-the-curve (AUC) and maximum concentration (Cmax) geometric mean
ratios of PF708 versus Forteo were within the 80-125% range required for concluding bioequivalence. We
initiated an immunogenicity/pharmacokinetics clinical study in osteoporosis patients in the fourth quarter of
2016. We believe that this study, along with the positive bioequivalence study, should satisfy the filing
requirements for PF708 through the 505(b)(2) regulatory pathway. The interim pharmacokinetic data from this
study is expected in the second half of 2017 and the immunogenicity data is expected in the first half of 2018.
We believe that the clinical program in the United States may be leveraged for regulatory filings in other
geographies, such as the European Union.

PF582 – Ranibizumab

PF582 is a biosimilar product candidate to Lucentis (ranibizumab), indicated for the treatment of visual
impairment due to neovascular, or wet, age-related macular degeneration (AMD), macular edema following
retinal vein occlusion, choroidal neovascularization secondary to pathologic myopia, diabetic macular edema and
diabetic retinopathy in patients with diabetic macular edema.

-1-

We have completed extensive bioanalytical similarity studies comparing PF582 to multiple lots of United

States and European Union sourced Lucentis, as well as comparability studies between multiple lots of PF582 at
the pilot scale and commercial scale. Based on our analytical and preclinical data package, the U.S. Food and
Drug Administration, or FDA, granted us a Biosimilar Initial Advisory Meeting which was held in January 2014.
We discussed the data that was generated prior to that date, our comparative clinical trial design and our strategy
for the comparison of European Union and the United States licensed reference products. In the subsequent
meeting minutes, the FDA indicated that our analytical data appear acceptable to support the development of
PF582 as a biosimilar candidate to Lucentis. Similarly, we have had discussions with the European Union’s
Committee for Medicinal Products for Human Use, or CHMP, and Health Canada.

In the third quarter of 2016, we announced top-line results from the Phase 1/2 trial, which showed that
PF582 was pharmacologically active and with a safety profile that was consistent with that of Lucentis. We
enrolled a total of 25 VEGF-inhibitor naïve patients with neovascular AMD in the PF582 Phase 1/2 trial (13
received PF582, including one sentinel patient who received open label PF582, 12 received Lucentis). All
patients received three monthly intravitreal injections. The primary endpoint of the study was safety and
tolerability of PF582 compared to that of Lucentis. There were no clinically meaningful differences in adverse
event profiles or intra-ocular pressure between PF582 and Lucentis. The efficacy and pharmacodynamic results
indicated that there were no clinically meaningful differences in best corrected visual acuity or decreases in
central retinal thickness between PF582 and Lucentis at any of the timepoints.

Vaccine Programs

Our Pfe¯nex Expression Technology® is also well suited for vaccine development. We are developing
Px563L, a novel anthrax vaccine candidate, in response to the United States government’s unmet demand for
increased quantity, stability and dose sparing regimens of anthrax vaccine. We initiated a randomized, placebo-
controlled Phase 1a trial in healthy subjects in the second half of 2015 to investigate the safety and
immunogenicity of Px563L, and we announced the interim analysis results in the second half of 2016. Findings
indicated that the vaccine was well-tolerated, with the potential to afford immunogenicity protection against
anthrax infection after only two injections (vs. three for the currently licensed anthrax vaccine product).

The development of Px563L is funded by the U.S. Department of Health and Human Services, through the

Biomedical Advanced Research and Development Authority, or BARDA, in accordance with a cost plus fixed
fee advanced development contract valued at up to approximately $143.5 million. In addition to the base period,
BARDA has now exercised additional phases of the development contract effective January 2017, allowing for
the continuing development of Px563L. The phase 2 study could initiate in 2018, provided the program continues
to successfully advance with the support of BARDA.

The development of Px533, a prophylactic vaccine candidate against malaria infection, has been funded by

Leidos, Inc., or Leidos, formerly Science Applications International Corporation, or SAIC, through its Malaria
Vaccine Production and Support Services contract with the National Institute of Allergy and Infectious Diseases,
or NIAID. Clinical trials for Px533 are controlled by NIAID.

Biosimilars Market Opportunity

A biosimilar is a biologic product that has been demonstrated to be highly similar to a biologic product that

is already licensed, also known as a reference product. By definition, a biosimilar expresses no clinically
meaningful differences when compared to a reference product in terms of safety, purity, and potency. In the next
several years, a large number of blockbuster products are expected to lose patent protection, opening up the
market for biosimilars.

It is our belief that this emerging biosimilar market will be significant as several biologic products reach

patent expiry. According to IMS Health, by 2020, eight biologic products are expected to lose patent protection
in the EU5 (France, Germany, Italy, Spain and the UK) and the US. Additionally, the abbreviated biosimilar

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regulatory pathways established via legislation such as the Patient Protection and Affordable Care Act (ACA),
coupled with an increasing mandate for lower drug costs by governments and private payers, has positively
positioned the biosimilars market for rapid expansion.

It has been reported that the global biosimilars market is expected to reach $10.9 billion by 2021 from $3.4
billion in 2016, at a compound annual growth rate of 26% from 2016 to 2020. We expect the biologics market to
shift toward biosimilars over the coming years, much like generic small molecule drugs, which currently
accounts for an estimated 89% of the dispensed prescription small molecule drug market in the United States.

Our Strategy

Our strategy is to utilize our Pfe¯nex Expression Technology® and our expertise in bioanalytical
characterization and product development to become a leading protein therapeutics company focused on
developing our own product candidates.

Our product candidate selection strategy focuses on products with large addressable markets, which are
expected to be free of intellectual property barriers in major markets over our projected approval timelines, and
for which our Pfe¯nex Expression Technology ® enables efficient and large-scale manufacture of high-value and
difficult-to-manufacture proteins. Our pipeline of product candidates and preclinical products under development
includes wholly-owned programs, programs that are being developed in a joint venture with Strides Arcolab
Limited (Strides Arcolab), and certain other products that are being developed in collaboration with Jazz
Pharmaceuticals Ireland Limited (Jazz). In addition, we are also developing proprietary vaccine candidates that
are being funded by the Department of Health and Human Services and the National Institutes of Health (NIH)
within the United States government.

The key elements to implement our strategy include the following:

• Develop and obtain regulatory approval of PF708 and maximize its commercial potential. We are
actively completing the necessary items that we believe will satisfy the filing requirements for the
505(b)(2) regulatory pathway in the United States to enable timeline regulatory approval as intellectual
property protection and regulatory exclusivity for Forteo expire. In the fourth quarter of 2016, we
initiated an immunogenicity/pharmacokinetics study in osteoporosis patients to compare the effects of
PF708 and Forteo. The interim pharmacokinetic data from this study is expected in the second half of
2017 and the immunogenicity data is expected in the first half of 2018. We anticipate the results of this
study will fulfill necessary filing requirements.

• Develop and obtain regulatory approval of PF582 and maximize its commercial potential. Following

the termination of our collaboration with Hospira, Inc., a subsidiary of Pfizer Inc. (together, with
Hospira, “Pfizer”), we are assessing the optimal development and commercialization strategy for
PF582 to enable timely regulatory approval following the expected expiration of intellectual property
protection and regulatory exclusivity for Lucentis.

• Develop vaccine programs primarily with non-dilutive government funding and other third-party
grants. Using our Pfe¯nex Expression Technology®, we are developing Px563L as a next generation
anthrax vaccine candidate that we believe will address the limitations of the existing approved product
including compliance, cost and potential fulfillment of the Strategic National Stockpile. We reported
interim results of an ongoing Phase 1a trial in the second half of 2016 and anticipate its completion in
the first half of 2017. The development of Px563L is funded through BARDA under a cost plus fixed
fee advanced development contract valued at up to approximately $143.5 million. NIAID continues to
evaluate our vaccine candidate, Px533, against malaria infection. Clinical development of Px533 is
controlled and funded by NIAID.

• Continue to develop our pipeline of product candidates. We intend to continue developing a pipeline
of additional biosimilar candidates, including PF529, a biosimilar candidate to Neulasta® and PF688, a

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biosimilar candidate to Cimzia®. We have also developed PF530, a biosimilar candidate to Betaseron.
We continue to evaluate new product candidates to add to our pipeline.

Biosimilars Background

The Biologics Price Competition and Innovation Act, or BPCIA, was enacted in 2010, creating an
abbreviated approval pathway for biosimilar products, referred to as the “351(k) pathway”. We believe the
FDA’s guidance to date provides the necessary clarity regarding approval requirements under the 351(k) pathway
to permit the development of our biosimilar product candidates and the ultimate submission of applications for
marketing approval for these product candidates. The first biosimilar in the United States, Zarxio® (filgrastim-
sndz), was approved by the FDA in 2015.

Biosimilars Development and Challenges

Product development progresses differently with biosimilars than with innovative biologic candidates. This

is a result of abbreviated development requirements for the approval of biosimilars as compared to innovative
biologic products. Because a biosimilar product may reference existing information regarding the safety, purity
and potency of a previously approved biologic product, a biosimilar product application emphasizes analytical
characterization to demonstrate similarity between the biosimilar and the reference product, which regulators
have already found to be safe and effective.

The development of proteins, such as biosimilars, requires several competencies which represent both
challenges and barriers to entry. Due to their inherent complexity, proteins require the use of living organisms to
efficiently produce them at large scale. Traditional techniques for protein production employ a trial and error
approach to production organism, or production strain, selection and process optimization, which is inherently
inefficient and typically produces suboptimal results. This historically inefficient process provides barriers to
create or replicate complex proteins, adds significant time to market and results in the high cost of goods typical
of biologic therapeutics. Together, these limitations pose significant hurdles for companies interested in entering
the market with biosimilar and therapeutic equivalents to branded products.

Our Approach

Our patented protein production platform, Pfe¯nex Expression Technology®, allows us to address hurdles to

development and enable our product candidates. We believe our technology confers several important
competitive advantages compared to traditional techniques for protein production, including the ability to
produce complex proteins with higher accuracy and greater degree of protein purity, as well as speed and cost
advantages. Our platform utilizes a proprietary high throughput robotically-enabled parallel approach, which
allows the construction and testing of thousands of unique protein production variables in parallel, thereby
allowing us to produce and characterize complex proteins while reducing the time and cost of development and
long-term production.

We have replaced the traditional, trial and error approach to protein production with a simultaneous, parallel
processing model that allows the construction and testing of thousands of unique protein production variables in
parallel. This technology, which became our Pfe¯nex Expression Technology® was originated at Mycogen
Corporation and further developed at The Dow Chemical Company , collectively, over a period of 20 years, and
was assigned to us in the 2009 spinout to form the technology basis of our company. We have continued to
improve the technology for the specific use in biopharmaceuticals development and manufacturing. We believe
our platform delivers a significant competitive advantage for protein production, including higher accuracy,
greater degree of protein purity, speed and lower costs.

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Pfe¯nex Expression Technology®

Protein Production Overview

Protein production is a fundamental activity necessary for biological drug development and manufacturing.

The most common method of manufacturing therapeutic proteins involves the use of engineered microorganisms.
Proteins produced using these organisms are referred to as recombinant proteins. Recombinant proteins are
produced by inserting DNA, or a gene, that codes for the protein, into a cell which then acts as a protein
production factory. Typically, this is accomplished by inserting DNA into an expression vector, which contains
genetic control elements that can be used to turn the gene on and off.

Our platform is based on automated high-throughput screening of large libraries of novel, genetically
engineered P. fluorescens bacterial expression strains. The libraries contain thousands of expression strains
which are constructed from a large inventory of expression vectors, or genetic elements, incorporated into
engineered P. fluorescens host strains. We then employ automated, robotically enabled parallel high-throughput
screening, incorporating extensive bioanalytical testing, in order to select strains from the library which express
the protein of interest at optimal yields, purity and potency. Extensive fermentation scouting experiments on the
selected strains allows for the identification of a final production strain with further improvements in the yield of
the active therapeutic protein.

Our patented Pfe¯nex Expression Technology® is capable of identifying a final production strain in
approximately nine weeks compared to approximately one year or more in the typical case, if even possible,
compared to the traditional trial and error approach as illustrated in the diagram below.

Differentiation of Today’s Process v. Pfenex Platform

Current Protein Production Process:
Handful of Experiments – Trial & Error

Pfenex Platform:  Thousands of Parallel Experiments
Faster, Scalable, Higher Quality, Lower Cost

“Do Loop 1”

Inadequate

“Good Enough”

Thousands of Expression Strains Cultured in Parallel

Some
Production 

Handful of Conditions

Refine conditions

High-Throughput Analytical
Quality, Titer & Function

Production Strain Down-Selection

DEVELOPMENT

24 Parallel 1L Fermentations

<9 weeks

Discovery

PC/tox

Early Stage

Late Stage

“Do Loop 2”

High-Throughput Analytical
Quality, Titer & Function

16 Parallel 1L Fermentations

High-Throughput Analytical:
Quality, Titer & Function

Current duration on average:  One year process!

Production Strain Producing High Titers of
High Quality Protein in ~ 9 Weeks

Our Pfe¯nex Expression Technology® platform consists of three primary elements that, when combined,
deliver a significant competitive advantage for protein production that differentiates us in the biopharmaceutical
industry.

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The three elements include:

• Robust Protein Production Organism

• Creation of Extensive Library of Protein Expression Variants

• Robotically Enabled High Throughput Screening

Robust Protein Production Organism

P. fluorescens has been used industrially where it has efficiently produced complex proteins. We exploit

certain attributes of the P. fluorescens bacterium that enables us to rapidly identify the optimal strain for a
specific protein of interest. The favorable attributes of the P. fluorescens bacterium include:

•

Secretion of soluble protein into the bacterial periplasm, or the space between the inner and outer
membrane in gram negative bacteria, resulting in increased recovery yields of properly folded protein

• P. fluorescens genome allows for modifications, including deleting protease genes, or nucleotides that
provide instructions for synthesis of RNA into a specific protease, and inserting chaperone and/or
disulfide bond isomerase genes, or nucleotides that provide instructions for synthesis of RNA into a
specific chaperone or disulfide isomerase, which overall increase the quality and production of
properly folded active full length proteins

•

Selection of expression strains without the use of antibiotics

• High cell density fermentation due to its obligate aerobe growth nature, or bacterium that can only

grow in the presence of oxygen, which improves the protein production for characterization, enables
consistent scale-up and long-term low cost of goods

Creation of Extensive Library of Protein Expression Variants

We have developed an extensive toolbox of protein production variants that can be readily accessed for
finding the best choice for manufacturing of a specific protein. This toolbox is continuously growing due to our
ongoing research and development efforts. We construct libraries of thousands of unique expression strain
variants by combining engineered P. fluorescens host strains with proprietary expression vectors. The engineered
P. fluorescens strains have reduced expression of protein degrading enzymes and/or increased levels of folding
elements while the expression vectors consist of plasmids with engineered genetic elements including promoters,
ribosome binding sites and secretion leaders. Determining which of these variants will improve production of any
particular protein cannot be determined from the amino acid sequence of the protein of interest. As a result, we
employ the automated high throughput screening of a large library of the strain variants in order to select the
strain that produces the protein of interest at optimal purity, yield and potency.

Robotically Enabled High Throughput Screening

Our high-throughput automation supports simultaneous, parallel evaluation of thousands of unique protein
production alternatives, enabling rapid identification of the optimal production strain for the protein of interest.
Our protein production technology employs rapid construction of protein production strains and testing
thousands of unique variants evaluated through automated sample analysis to determine the titer, or quantity of
the product per unit volume, of high quality protein each expression strain produces, which can then be analyzed
through our high throughput analytical capacity. Our proprietary, robotically enabled automated high throughput
screening process, along with our optimized production organism and toolbox of variants, as well as our
expertise in analytical characterization, expedites the development of an optimal protein production engine from
approximately one year in a typical case for traditional approaches, if at all possible, to approximately nine
weeks with our Pfe¯nex Expression Technology®.

Reagent Proteins

Utilizing our Pfe¯nex Expression Technology®, we supply preclinical and cGMP-grade CRM197 to the
biopharmaceutical and vaccine development community. We currently have supply agreements for the supply of
cGMP CRM197.

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Our Product Candidates

The development of our own portfolio of product candidates has been enabled by our successful history of

meeting analytically rigorous client specifications of protein quality, yield and potency using our Pfe¯nex
Expression Technology®. Our pipeline includes product candidates and preclinical products under development
in various stages of development. Details of our pipeline are included below.

Therapeutic Equivalent, Biosimilar and Next Generation Candidates

PF708 – Teriparatide

One of our lead product candidates, PF708, is a peptide product candidate that is being developed as a
therapeutic equivalent to the reference listed drug Forteo, an injectable prescription medicine marketed by Eli
Lilly for the treatment of osteoporosis patients at high risk of fractures. Teriparatide is a shortened version of the
naturally occurring parathyroid hormone (amino acids 1-34) that promotes bone growth. To date, we have
demonstrated production of teriparatide in quantities that we believe predict a competitive cost of goods. Despite
Forteo’s status as a biologic peptide currently manufactured in E. coli, due to its size (less than or equal to
40 amino acids), it is considered a small molecule. As a result, we are developing PF708 pursuant to the
Section 505(b)(2) regulatory pathway in the United States.

Market Overview

The global osteoporosis market represents a significant opportunity, with product sales that are estimated to

grow to approximately $5.2 billion in the United States, Japan and the five major European Markets in 2021.
Treatment with teriparatide is the only treatment approach that promotes bone growth currently available for the
treatment of osteoporosis. According to the National Institutes of Health (NIH), it is estimated that approximately
44 million Americans either have osteoporosis or are at increased risk due to low bone mass (osteopenia). Forteo
(marketed as Forsteo in Europe) is the only product currently approved that builds bone primarily by increasing
the activity of osteoblasts (cells that deposit bone). Worldwide sales of Forteo were approximately $1.4 billion in
2015, according to Eli Lilly.

Development

We have performed an extensive bioanalytical comparative analysis of PF708 and Forteo. Based on what

we believe to be equivalent results to date, we have not conducted preclinical in vivo studies for safety or
efficacy purposes prior to initiating clinical investigation. We have also completed an initial assessment of the
PF708 and Forteo injection pens, and we believe that the two injection devices are functionally equivalent. We
completed a pharmacokinetic bioequivalence study in healthy subjects in the first half of 2016, and we initiated a
comparative immunogenicity/pharmacokinetics study in osteoporosis patients in the fourth quarter of 2016. The
interim pharmacokinetic data from this study is expected in the second half of 2017 and the immunogenicity data
is expected in the first half of 2018.We anticipate that the study results will support the potential licensure of
PF708 under the Section 505(b)(2) regulatory pathway in the United States.

PF582 – Ranibizumab

PF582, our other lead product candidate, is a biosimilar product candidate to Lucentis (ranibizumab),
indicated for the treatment of visual impairment due to neovascular, or wet, age-related macular degeneration
(AMD), macular edema following retinal vein occlusion, choroidal neovascularization secondary to pathologic
myopia, diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema.

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Market Overview

Lucentis achieved approximately $3.6 billion in global product sales in 2015. By the second quarter of 2018,

markets with 2015 Lucentis sales of approximately $530 million are expected to lose patent protection, and
become available to biosimilars. By the second quarter of 2020, markets with an additional $1.8 billion in 2015
Lucentis sales are expected to lose patent protection and become available for biosimilars, and after January 2022
markets with an additional $1.2 billion in 2015 sales are expected to also lose patent protection.

Given the characteristics of the patient populations for each of its approved indications, we believe

ranibizumab has attractive long-term growth prospects. In addition, we believe, the market is underpenetrated for
the approved indications allowing future growth opportunities particularly for lower cost biosimilars.

• Wet AMD—Age-related macular degeneration, or AMD, is the leading cause of severe vision loss in
people over age 60, and it impacts approximately 30-50 million people worldwide. AMD occurs when
the center of the retina, known as the macula, deteriorates. In the United States, approximately
15 million people suffer from AMD. Wet AMD accounts for about 10% of all cases of AMD and about
600,000 new cases of wet AMD are diagnosed each year globally.

• Diabetic Macular Edema—Diabetic macular edema, or DME, is the leading cause of blindness in
young adults in developed countries. The global prevalence of DME is approximately 21 million
people. Worldwide, 285 million adults suffer from diabetes, and the number of adults who suffer from
diabetes is projected to increase by 69% in developing countries and 20% in developed countries from
2010 to 2030. Approximately 28% of patients with type 2 diabetes and 12% of patients with type 1
diabetes will develop DME.

• Retinal Vein Occlusion—Retinal vein occlusion, or RVO, is the blockage of the small veins that carry
blood away from the retina, potentially causing glaucoma and loss of vision. RVO affects more than
one million people in the United States and 16.4 million people globally. In the United States,
approximately 193,000 new cases of RVO are diagnosed each year.

• Myopic Choroidal Neovascularization—Myopic choroidal neovascularization, or mCNV, is a

complication of severe near-sightedness that can lead to blindness. In mCNV, new, abnormal blood
vessels grow directly into the retina. These vessels may break and leak blood or fluid into the retina,
which can cause irreversible central vision loss. mCNV affects approximately 41,000 people in the US,
and it most commonly affects people between ages 45 and 64. It is estimated that mCNV exists in 5%-
10% of highly myopic patients.

Development

We have completed extensive bioanalytical similarity studies comparing PF582 to multiple lots of United

States and European Union sourced Lucentis, as well as comparability studies between multiple lots of PF582 at
the pilot scale and current Good Manufacturing Practice, or cGMP, commercial scale. We have also completed a
preclinical study using an animal model that demonstrated, when injected into animal eyes, PF582 and Lucentis
yielded similar tolerability and pharmacological profiles. Based on our analytical and preclinical data package,
the FDA granted us a Biosimilar Initial Advisory Meeting which was held in January 2014 to discuss the data we
had generated to date, our comparative clinical trial design and our strategy for the comparison of European
Union and United States licensed reference products. In the subsequent meeting minutes, the FDA indicated that
our analytical data appear acceptable to support the development of PF582 as a biosimilar candidate to Lucentis.

In the third quarter of 2016, we announced the results of a randomized Phase 1/2 trial in patients with wet
AMD. We believe that positive results from a future global comparative clinical trial should provide sufficient
data to seek and secure marketing approval in our target markets.

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Px563L

Px563L is a novel anthrax vaccine candidate based on a recombinant modified form (mutant) of the

protective antigen from Bacillus anthracis (anthrax). We are developing Px563L in response to the United States
government’s unmet demand for increased quantity, stability and dose sparing regimens of anthrax vaccine. We
believe that Px563L can address each of these demands. We initiated a randomized, placebo-controlled Phase 1a
trial in healthy subjects in the second half of 2015 to investigate the safety and immunogenicity of Px563L, and
we announced the interim analysis results in the second half of 2016. Findings indicated that the vaccine was
well-tolerated, with the potential to afford immunogenicity protection against anthrax infection after only two
injections (vs. three for the currently licensed anthrax vaccine product). The development of Px563L is funded by
the U.S. Department of Health and Human Services (HHS) through BARDA under a contract providing up to
$143.5 million in funding.

Market Overview

In October 2001, letters contaminated with anthrax spores were delivered to government officials and
members of the media in the United States. As a result of these attacks, 22 people became infected with anthrax
and five people died. In response to this and other terrorist attacks around the world, the biodefense market has
grown dramatically. In December 2016 the Centers for Disease Control (CDC) signed a procurement contract for
BioThrax valued at up to $911 million to supply to the Strategic National Stockpile that represents approximately
29.4 million doses through September 2021. The federal government spends billions of dollars in biodefense
through HHS, CDC, NIAID and Office of Public Health Preparedness and Response. In 2013, the Pandemic and
All-Hazards Preparedness Reauthorization Act, or PAHPRA, which was originally passed in 2006 to improve the
United States’ public health and medical preparedness and response capabilities for emergencies, authorized $2.8
billion for the procurement of countermeasures for biological, chemical, radiological and nuclear attacks. If
successful with clinical development, we believe we may be able to enter into a procurement relationship with
the US federal government to supply a next generation recombinant protective antigen (rPA) based anthrax
vaccine to the Strategic National Stockpile.

Development

In preclinical animal studies, Px563L has resulted in a greater immune response than the only available
anthrax vaccine, BioThrax, and has the potential to provide longer protective immunity with fewer vaccinations.
Through the application of our Pfe¯nex Expression Technology® we have developed a robust production strain for
manufacturing that has demonstrated an ability to produce large amounts of mutant recombinant protective
antigen, or mrPA.

In August 2016, we announced positive immunogenicity and safety data from Day 70 analysis of the
Px563L anthrax vaccine study. The randomized, double-blind, placebo-controlled Phase 1a study enrolled three
cohorts in a dose-escalating manner (10 mcg, 50 mcg and 80 mcg of antigen). Within each cohort, subjects
received Px563L, RPA563 or placebo in an 8:8:2 ratio. Subjects were administered two doses of vaccine or
placebo 28 days apart. Interim results indicated that the vaccine was well-tolerated, with the potential to afford
immunogenicity protection against anthrax infection after only two injections (vs. three for the currently licensed
anthrax vaccine product). Immunogenicity was assessed by toxin-neutralizing antibody (TNA) expressed as 50%
neutralizing factor (NF50), with a threshold value ≥0.56 correlating with significant survival in animal models of
anthrax infection. On Day 70, 100% of Px563L subjects at the 10 mcg and 80 mcg dose levels achieved a TNA
NF50 ≥0.56, and 87.5% at the 50 mcg dose level achieved the target threshold. An additional success criterion
for assessing anthrax vaccine immunogenicity is for the lower confidence limit (LCL), or the lower bound of
95% confidence interval, of the percentage of subjects who met or exceeded the TNA NF50 threshold of 0.56, to
be greater than or equal to 40%. On Day 70, all doses of Px563L exceeded this threshold, which was established
by the currently licensed anthrax vaccine for the indication of post-exposure prophylaxis.

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In addition, we have developed a production process for the large scale manufacturing of bulk mrPA. We
announced positive interim results from a Phase 1a study in healthy subjects in the second half of 2016, and we
anticipate study completion in the first half of 2017.

Additional Products Under Development

Given the Jazz collaboration and our recent pipeline review, we have decided to advance the hematology

assets that are part of the Jazz collaboration ahead of the PF530 biosimilar Betaseron opportunity. The expenses
associated with PF530 will be reduced as part of the portfolio re-alignment. We completed a Phase 1 trial of
PF530, a biosimilar candidate to Betaseron, in 2015 which enrolled 12 healthy subjects. Based on the analysis of
the trial PK and PD parameters, no meaningful differences between PF530 compared to the reference compound
were observed. Potential strategic opportunities for the PF530 program will be explored, given the successful
advancement of PF530 and the positive regulatory feedback.

We also have a number of preclinical products under development. We are currently in process development

for PF529, a peg-filgrastim biosimilar candidate to Neulasta, as well as for PF690 pegaspargase, a biosimilar
candidate to the reference product Oncaspar. Regulatory feedback for PF529 was received in 2016 and supported
the feasibility of development under the 351(k) biosimilar pathway. We continue to evaluate the potential
resource requirements and timeline for development. Additional products in process development include PF444-
human growth hormone, and PF688-certolizumab-pegol, which are being developed as biosimilars of
Genotropin, and Cimzia, respectively.

Collaborations, Joint Development, and Licenses

Jazz Pharmaceuticals

In July 2016, we entered into a development and license agreement, or the Jazz Agreement, with Jazz

Pharmaceuticals Ireland Limited, or Jazz, for the development and commercialization of multiple early stage
hematology product candidates. The agreement also includes an option for Jazz to negotiate a license for a
recombinant pegaspargase product candidate with us. Under the Jazz Agreement, we received an upfront and
option payment totaling $15 million in July 2016 and may be eligible to receive additional payments of up to
$166 million based on achievement of certain research and development, regulatory and sales related milestones,
including up to approximately $41 million for certain non-sales-related milestones. The total milestones are
categorized as follows: $7 million are based on achievement of certain research and development milestones;
$34 million for certain regulatory milestones; and $125 million for sales-related milestones. For the non-sales-
related milestones, we conducted an evaluation of whether they will be recorded using the milestone method and
as a result of this evaluation, we estimate approximately $7 million of these non-sales-related milestones are
deemed to be substantive. We may also be eligible to receive tiered royalties on worldwide sales of any products
resulting from the collaboration. We and Jazz will both be contributing to the development efforts. Unless
terminated earlier, the Jazz Agreement will continue on a product-by-product basis for as long as Jazz is
commercializing or having commercialized the products under the Jazz Agreement.

Pfizer

In February 2015, we entered into a development and license agreement with Pfizer for the development and

commercialization of PF582. Under the terms of the development and license agreement, in March of 2015 we
received a non-refundable license payment of $51 million on receipt of antitrust approval. We regained the full
rights to PF582 following Pfizer’s strategic review of the current therapeutic focus of its biosimilar pipeline. To
that effect, in August 2016, we entered into a termination agreement, pursuant to which the development and
license agreement was terminated and all rights to PF582 were returned to us.

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Strides Arcolab

In December 2012, we entered into a Joint Development & License Agreement, or JDLA, with Strides
Arcolab, to develop biosimilar products according to development plans to be mutually agreed upon by us and
Strides Arcolab. Under such development plans, we will generally be responsible for establishing and
characterizing a research cell bank of the protein production strain and developing a manufacturing process and
analytical methods, while Strides Arcolab will generally be responsible for developing master and working cell
banks for the applicable protein production strain, developing a formulation for the applicable biosimilar product,
manufacturing the biosimilar for Phase 1 trials, conducting preclinical and Phase 1 trials and managing
regulatory matters. Each of Strides Arcolab and us will bear our own costs for the aforementioned development
activities. Each of Strides Arcolab and us must use commercially reasonable efforts to accomplish the objectives
set forth in the development plan for each biosimilar product and certain milestones set forth in the JDLA.
Except pursuant to the JDLA during its term, neither we nor Strides Arcolab may develop, manufacture, supply
or commercialize any product that is being or has been developed under the agreement or assist any third party to
do the same.

In March 2013, we entered into a joint venture agreement, or JVA, with Strides Arcolab to form a joint
venture company, or JV, to develop and commercialize biosimilar products developed under the JDLA that have
completed Phase 1 trials. Under the terms of the JVA, when formed, we will own a 49% equity interest in the JV,
while Strides Arcolab will own a 51% equity interest in the JV. Both we and Strides Arcolab will have equal
board representation and equal voting rights.

In February 2015, we notified Strides Arcolab that we were removing PF530 Interferon beta-1b, PF726
PEGylated Interferon beta-1b and PF529 PEGylated filgrastim from the JDLA. We intend to independently
advance these candidates as wholly owned products.

Currently there are two biosimilar candidates for development under the JDLA and potential further

development and commercialization by the JV:

•

PEGylated interferon alpha-2a (a biosimilar candidate to Roche’s Pegasys); and

• Human growth hormone (a biosimilar candidate to Pfizer’s Genotropin).

After transfer of a biosimilar product to Strides Arcolab, Strides Arcolab will be responsible for

manufacturing such biosimilar product, preparing and filing all regulatory filings and conducting the Phase 1
study. Upon successful completion of the first Phase 1 trial for each biosimilar candidate, the product will
transfer to the JV and the JV will be responsible for all regulatory filings and approvals, clinical trials,
commercialization strategies and distribution of the applicable biosimilar product upon approvals. Also
transferred to the JV are all associated data, rights and assets, including any inventions developed by us or Strides
Arcolab under the JDLA and all intellectual property rights therein. The JDLA will continue on a biosimilar
product-by-biosimilar product basis until successful completion of the first Phase 1 trial for such biosimilar
product. Either we or Strides Arcolab may terminate the JDLA in its entirety for the other party’s insolvency, or
in its entirety or with respect to the applicable biosimilar product for the other party’s material breach of the
JDLA. In addition, if the JVA is terminated in its entirety, the JDLA will automatically terminate.

The JVA will remain in effect so long as there is at least one biosimilar product under development or
commercialization by the JV. If the JV fails to initiate the first commercial sale of a biosimilar product within the
timeframe set forth in the plan for such biosimilar product, either we or Strides Arcolab may terminate the JVA
with respect to such biosimilar product upon notice to the other party. Beginning March 7, 2018, either we or
Strides Arcolab may offer to sell our or Strides Arcolab’s entire equity interest in the JV to the other party, at
which time the other party must either buy the first party’s entire interest in the JV or sell to the first party such
other party’s entire interest in the JV. In addition, if either we or Strides Arcolab materially breaches the JVA or
become insolvent and fail to cure such breach or insolvency within a specified period of time, the other party

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may require the breaching or insolvent party to buy such other party’s entire equity interest in the JV or to sell
such breaching or insolvent party’s entire equity interest in the JV to such other party.

The Dow Chemical Company

On November 30, 2009, we entered into a series of agreements with Dow Global Technologies LLC and/or
The Dow Chemical Company, or collectively, Dow, including a technology assignment agreement, a technology
licensing agreement, and a grant-back and technology license agreement. Under the technology assignment
agreement, Dow assigned to us certain patents, know-how and trademarks relating to our Pfe¯nex Expression
Technology®. Under the technology licensing agreement, Dow granted us exclusive licenses to exploit certain
patents relating to RNA viruses and oral immunization methods (each of which were subsequently terminated),
and certain amended recombinant cells, and a non-exclusive license to exploit certain patents relating to
production and isolation techniques for peptides and proteins made using our Pfe¯nex Expression Technology®.
Under the grant-back and technology license agreement, we granted to Dow exclusive and non-exclusive licenses
under certain patents and know-how relating to our Pfe¯nex Expression Technology® to use certain biological
materials to make, use and commercialize products in certain fields of use that do not include human
therapeutics.

The U.S. Department of Health and Human Services

In July 2010, we entered into a contract with BARDA, a division of the Office of the Assistant Secretary for
Preparedness and Response in the U.S. Department of Health and Human Services, to develop a production strain
and process for the production of bulk recombinant Protective Antigen, or rPA, from anthrax. Under the contract,
we agreed to provide protein production and process development services to BARDA. The contract was
amended several times to advance development of the product, and BARDA exercised options to provide
additional funding and extend the term of the contract. In December 2014, we filed the investigational new drug,
or IND, application for Px563L. BARDA extended the contract in December 2014 and provided additional
funding, increasing the total contract to $25.2 million. A total of $24.8 million had been recognized as revenue
under the development contract, which was completed in August 2015.

In August 2015, we entered into a five-year, cost plus fixed fee contract valued at up to $143.5 million with

BARDA for the advanced development of Px563L, which is a mutant recombinant protective antigen anthrax
vaccine. The contract consists of a 30-month base period with total funding up to $15.9 million that will fund
activities related to cGMP manufacturing of drug product and a Phase 1a clinical study. In addition to the base
period, there are eight option periods, with potential additional funding of up to $127.6 million that will fund
activities including completion of a Phase 1b clinical study, a Phase 2 clinical study and non-clinical efficacy
studies, as well as manufacturing technology transfer and optimization, process and analytical method validation
and consistency lot manufacture. In addition to the base period, BARDA has exercised additional phases of the
development contract effective January 2017, allowing for the continuing development of Px563L. The phase 2
study could initiate in 2018, provided the program continues to successfully advance with the support of
BARDA. We believe the successful completion of the activities under this contract could lead to a procurement
contract for supply of Px563L to the Strategic National Stockpile.

As the prime contractor, we are responsible for performing activities under a research plan proposed by us

and accepted by BARDA. We are also obligated under the contract to satisfy various federal reporting
requirements, including technical reporting with respect to our development activities, reporting with respect to
intellectual property and financial reporting. In addition, certain technical documents and our clinical trial
protocols may be reviewed by BARDA prior to their finalization and/or submission.

Under standard government contracting terms, the government receives only limited rights for government
use of certain of our pre-existing data and certain data produced with non-federal funding, to the extent such data
are required for delivery to BARDA under the project. The United States government receives unlimited rights to

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use and disclose new data first produced under the project with BARDA funding. If the product is successfully
developed and achieves marketing authorization, we would have the commercial rights to the anthrax vaccine;
provided that the United States government is entitled to a nonexclusive, worldwide, royalty-free license to practice
or have practiced any patent on an invention that is conceived or first reduced to practice under the project, and may
obtain additional rights if we do not elect to retain ownership of a subject invention or if we do not satisfy certain
disclosure and patent prosecution obligations with respect to a subject invention. Our contract with BARDA does
not entitle the government to any sales royalties or other post-commercialization financial rights.

BARDA is entitled to terminate the project for convenience at any time, and is not obligated to provide
continued funding beyond current year amounts allotted from Congressionally approved annual appropriations.

The National Institute of Allergy and Infectious Diseases (NIAID)

In September 2012, we entered into a contract with NIAID for the development of a next generation anthrax

vaccine. Under the contract, which was amended in April 2013 and November 2013, we have agreed to provide
services to NIAID for approximately 25 months under a cost plus fixed fee contract with a total value of
approximately $2.2 million. In addition to the base period, NIAID has 13 options to extend the term of the
contract, with payments totaling approximately $22.9 million. NIAID exercised an option effective January 2015
and another effective May 2016.

As the prime contractor, we are responsible for performing activities under a research plan proposed by us

and accepted by NIAID. We are also obligated under the contract to satisfy various federal reporting
requirements, including technical reporting with respect to our development activities, reporting with respect to
intellectual property and financial reporting.

Under standard government contracting terms, the government receives only limited rights for government
use of certain of our pre-existing data and certain data produced with non-federal funding, to the extent such data
are required for delivery to NIAID under the project. The United States government receives unlimited rights to
use and disclose new data first produced under the project with NIAID funding. If an anthrax vaccine is
successfully developed and achieves marketing authorization we would have the commercial rights to the anthrax
vaccine; provided that the United States government is entitled to a nonexclusive, worldwide, royalty-free license
to practice or have practiced any patent on an invention that is conceived or first reduced to practice under the
project, and may obtain additional rights if we do not elect to retain ownership of a subject invention or if we do
not satisfy certain disclosure and patent prosecution obligations with respect to a subject invention. Our contract
with NIAID does not entitle the government to any sales royalties or other post-commercialization financial
rights.

NIAID is entitled to terminate the project for convenience at any time, and is not obligated to provide
continued funding beyond current year amounts allotted from Congressionally approved annual appropriations.

Customers

As of December 31, 2016, we had generated only limited revenue from government contracts, service
agreements, collaboration agreements, and reagent protein product sales. Our total revenue was $60.2 million,
$9.6 million and $10.6 million in 2016, 2015 and 2014, respectively. In 2016, a significant portion of our revenue
was derived from recognizing $45.8 million in revenue upon termination of the Pfizer agreement in August 2016,
in addition to revenue derived from development and license agreements. In 2015 and 2014, a significant portion
of our revenue was derived from developing proprietary vaccine candidates for government agencies.

For the year ended December 31, 2016, Pfizer accounted for more than 10% of our revenue. For the year
ended December 31, 2015, BARDA and Pfizer each accounted for more than 10% of our revenue. For the year
ended December 31, 2014, BARDA, NIAID and Boehringer Ingelheim International GmbH each accounted for
more than 10% of our revenue.

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Government Regulation

Government authorities in the European Economic Area, at European Union and national Member State
level, and in United States, at the federal, state and local level, extensively regulate, among other things, the
research, development, testing, manufacturing, labeling, packaging, promotion, advertising, storage, distribution,
marketing, post-approval monitoring and reporting, and export and import of drugs and biologics such as those
we are developing. We, along with third-party contractors, will be required to navigate the various preclinical,
clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we
wish to conduct studies or seek approval or licensure of our product candidates. The process of obtaining
regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes
and regulations require the expenditure of substantial time and financial resources.

European Economic Area Regulation

In the European Economic Area, or EEA, comprising the European Community (European Union) plus
Iceland, Liechtenstein and Norway, the information that must be submitted to the European Medicines Agency,
or EMA, or to the competent authorities in the relevant European Union Member States varies depending on
whether the biological medicinal product is a new product, whose quality, safety and efficacy has not previously
been demonstrated in humans or a product whose known biological active substance and certain other properties
are similar to those of a previously authorized (reference) biological medicinal product. The European Directive
2001/83/EC as amended defines a medicinal product as any substance or combination of substances:

•

presented as having properties for treating or preventing disease in human beings; or

• which may be used in or administered to human beings either with a view to restoring, correcting or

modifying physiological functions by exerting a pharmacological, immunological or metabolic action,
or to making a medical diagnosis.

Directive 2001/83/EC as amended further defines the category of biological medicinal products as:

•

a product, the active substance of which is a biological substance. A biological substance is a substance
that is produced by or extracted from a biological source and that needs for its characterization and the
determination of its quality a combination of physico-chemical-biological testing, together with the
production process and its control.

Examples of biological medicinal products include recombinant proteins, monoclonal antibodies, vaccines,

and products derived from human blood or plasma.

Approval of New Biological Medicinal Products

In the EEA, all medicinal products (biological or not) can only be commercialized after obtaining a

Marketing Authorization, or MA. There are two types of MA:

The Community MA, which is issued by the European Commission through the Centralized Procedure,

based on the opinion of the CHMP of the EMA, is valid throughout the entire territory of the EEA. The
Centralized Procedure is mandatory for certain types of products, such as medicinal products derived from
certain biotechnology processes (including biotechnology-derived proteins such as the ones we make), orphan
medicinal products, and medicinal products containing a new active substance indicated for the treatment of
AIDS, cancer, neurodegenerative disorders, diabetes and auto-immune and viral diseases. The Centralized
Procedure is optional for products containing a new active substance not yet authorized in the EEA, or for
products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of
public health in the European Union.

National MAs, which are issued by the competent authorities of the Member States of the EEA and only

cover their respective territory, are available for products not falling within the mandatory scope of the

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Centralized Procedure. Where a product has already been authorized for marketing in a Member State of the
EEA, this National MA can be recognized in other Member States through the Mutual Recognition Procedure. If
the product has not received a National MA in any Member State at the time of application, it can be approved
simultaneously in various Member States through the Decentralized Procedure.

Under the above described procedures, before granting the MA, the EMA or the competent authorities of the

Member States of the EEA make an assessment of the risk-benefit balance of the product on the basis of
scientific criteria concerning its quality, safety and efficacy.

More concretely, the requirements for centralized marketing authorization of a new biological medicinal

product in the EEA generally include but are not limited to:

•

•

•

•

•

•

•

•

•

•

•

•

•

submission of the results of pharmaceutical (physico-chemical, biological or microbiological) tests and
preclinical (toxicological and pharmacological) tests through laboratory tests and animal studies in
compliance with Good Laboratory Practice, or GLP;

submission to the competent authorities of a Clinical Trial Application, or CTA, which must become
effective before human clinical trials may begin and must include the protocol, Investigator’s
Brochure, Investigational Medicinal Product-related data, and independent Ethics Committee approval;

submission of the results of adequate and well-controlled clinical trials to establish the quality, safety
and efficacy of the product for each indication;

a statement to the effect that clinical trials carried outside the European Union meet the ethical
requirements of Directive 2001/20/EC;

submission of an application for marketing authorization to the EMA or to the competent authorities of
the relevant EU Member States;

establishment of the applicant in the EEA;

description of the qualitative and quantitative particulars of all constituents of the medicinal product;

evaluation of the potential environmental risks posed by the medicinal product;

description of the manufacturing method, description of the control measures employed by the
manufacturer, and a document showing that the manufacturer is authorized in his own country to
produce medicinal products;

a summary of product characteristics, therapeutic indications, adverse reactions, dosage,
pharmaceutical form, route of administration and expected shelf life;

additional information for specific classes of medicinal products, such as a Vaccine Antigen Master
File documentation for vaccine products;

a summary of the pharmacovigilance system, the risk management plan describing the risk-
management system, and proof that the applicant has the services of a qualified person responsible for
pharmacovigilance as well as the necessary means for fulfilling the EU pharmacovigilance obligations
including the notification of any adverse reaction suspected of occurring either in the EEA or in a third
country; and

review by EMA’s CHMP or the competent authorities in the relevant European Union Member States
and approval of the marketing authorization application.

Preclinical tests include laboratory evaluations of the product’s structure, purity and biological activity, as

well as animal studies to determine toxicity and pharmacology. An Investigational Medicinal Product (IMP)
sponsor must submit a CTA to the competent authority prior to initiation of human clinical trials. The application
process to perform a clinical trial in the EEA is governed on a country-by-country basis. A sponsor must apply in

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each country in which it intends to conduct any part of a human clinical trial. While the process is similar in most
countries, additional materials may be required in certain instances. For example, in many, but not all European
countries, a sponsor must submit a copy of the insurance coverage obtained to cover the clinical study. Australia
and New Zealand adhere to EMA guidelines with respect to the regulation of IMPs and clinical trials.

Assuming successful completion of the required clinical testing, and having met all criteria set forth by
Directive 2001/83/EC and Regulation (EC) No 726/2004, the applicant may choose to proceed with submission
of marketing authorization application. If the application is accepted for review in the Centralized Procedure,
within 210 days (excluding clock stops), the EMA’s CHMP will issue an opinion on whether the conditions for
granting market authorization are satisfied. During the review period, the scientific committees will review the
scientific data, may request for independent testing of the medicinal product, its starting materials, or other
constituent materials, may request supplemental information from the applicant, may request for proof of cGMP
compliance of the manufacturer, and may request for said manufacturing facilities to be inspected.

Accelerated Review

Under the Centralized Procedure in the European Union, the maximum timeframe for the evaluation of a

marketing authorization application is 210 days (excluding clock stops, when additional written or oral
information is to be provided by the applicant in response to questions asked by the EMA’s CHMP). Accelerated
evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a
major public health interest, particularly from the point of view of therapeutic innovation. In this circumstance,
EMA ensures that the opinion of the CHMP is given within 150 days, excluding clock stops.

Approval of Similar Biological Medicinal Products

Similar biological medicinal product applications of medicinal products authorized via the Centralized
Procedure have automatic access to the Centralized Procedure. Similar biological medicinal products that do not
fall under the mandatory scope can, at the request of the applicant, be accepted for consideration under the
Centralized Procedure, when the applicant shows that the medicinal product constitutes a significant therapeutic,
scientific or technical innovation or when the applicant shows that the granting of a Community authorization for
the medicinal product is in the interest of patients at European Union level.

A similar biological medicinal product, also known as a biosimilar, is a product that is similar to a biological
medicine that has already been authorized, the so-called “reference medicinal product.” The active substance of a
similar biological medicinal product is a known biological active substance and similar to the one of the
reference medicinal product. A similar biological medicinal product and its reference medicinal product are
expected to have the same safety and efficacy profile and are generally used to treat the same conditions.

The similar nature of a biosimilar and a reference product is demonstrated by comprehensive comparability

studies covering quality, biological activity, safety and efficacy. The dosage and route of administration should
be the same while deviations in formulation or inactive substances require justification or further studies.
Intended changes to improve efficacy are not compatible with a biosimilarity approach. The minimum
expectation of data supplied with the application will include pharmaceutical, chemical, and biological
preclinical data, as well as bioequivalence and bioavailability (bodily distribution and concentration) clinical
data. The type and amount of additional information, such as toxicological and other preclinical and clinical data,
is determined on a case-by-case basis. Unlike in the United States, the directives and guidelines governing the
EEA do not explicitly provide for the designation of interchangeability of similar biological medicinal products,
nor does the EMA submit an opinion on whether a biosimilar can be used interchangeably with its reference
product.

EMA guidelines suggest that clinical trials comparing a biosimilar candidate to a reference medicinal
product be designed such that they will demonstrate not only similar efficacy but also similar clinical outcome

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with respect to safety. Clinical trials designed to establish the expectation of equivalent clinical outcomes for any
one patient require a sufficiently large number of patients in the study such that certain statistical measures are
satisfied. As such, equivalence trials are usually more expensive and longer in duration than non-inferiority trials
that may be employed in other medicinal product categories. The EMA recommends engaging in discussions
with regulatory authorities if the use of a non-inferiority design is being considered. If a reference product is
approved for more than one therapeutic indication, the efficacy and safety of the biosimilar has to be justified or,
if necessary, demonstrated separately for each of the claimed indications. This may include a review of clinical
experience and available literature data, or the execution of further non-clinical or appropriate clinical studies.

The EMA provides additional specific guidance and requirements for products being developed as
biosimilar candidate to EEA-authorized Interferon-beta 1a or 1b and Interferon-alpha 2a or 2b. The guidance
outlines specific types of preclinical data and clinical studies required to support the claim of biosimilarity.
Additionally, the guidelines provide specific considerations for assessing clinical safety and for post-
authorization pharmacovigilance monitoring.

European Union legislation provides (with respect to reference products for which a marketing authorization

was applied for after October 30, 2005 under the Decentralized, Mutual Recognition and national procedures, or
after November 20, 2005, for products authorized under the Centralized Procedure) for an eight-year period of
data protection and ten-year period of market exclusivity for medicinal products which received marketing
authorization in accordance with, respectively, Directive 2001/83/EC as amended or Regulation (EC) No
726/2004 as amended. The provisions also state that if, during the first eight years of authorization, the holder
obtains an authorization for one or more new therapeutic indications which are deemed to have significant
clinical benefit as compared to existing therapies, the original market exclusivity can be extended to a maximum
of 11 years. The data and market exclusivity periods start from the date of the initial authorization, which for
reference medicinal products authorized through the Centralized Procedure is the date of notification of the
marketing authorization decision to the marketing authorization holder of the reference product.

Post-Approval Requirements

Once granted, initial marketing authorization of a medicinal product is valid for five years. The

authorization may be renewed after five years on the basis of a reevaluation of the risk-benefit balance. At that
point, once renewed, the marketing authorization is valid indefinitely or, if justified on grounds of
pharmacovigilance, may be restricted to an additional five-year authorization period.

Marketing authorization holders are required to maintain a pharmacovigilance system and to maintain
detailed records of all suspected adverse reactions in the EEA or in a third country. Serious suspected adverse
reactions are to be communicated to the appropriate EEA regulatory authorities no later than 15 days after receipt
of the information. EEA regulations require periodic safety reporting leading up to and following market
authorization, based on a defined schedule, for as long as the product is marketed, or when immediately
requested by regulatory authorities. An increase in incidents of adverse events or any cause for a change in
opinion by the EMA pertaining to the risk-benefit balance may lead to suspension, variation, or revocation of
marketing authorization and would severely impact our business.

EEA regulations also stipulate that regulators, such as the Competent Authorities of the EEA Member

States, independently or coordinated by the EMA, may carry out repeated or unannounced inspections of the
medicinal product manufacturer or at the premises of the marketing authorization holder, regarding compliance
with cGMP principles and guidelines. Compliance issues identified at our facilities or at third-party
manufacturers may disrupt clinical or commercial production or distribution or require substantial resources to
correct. This may result in the delay of clinical trials or commercial product launch. Discovery or problems with
the product or the failure to comply with applicable requirements may result in restrictions on a product, the
manufacturer or the holder of a marketing authorization, including withdrawal or recall of the product from the
market or other EMA or EEA Competent Authority initiated action that could delay or prohibit future marketing.

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Additionally, new government regulations may be established that could delay or prevent regulatory approval of
our products under development.

United States Government Regulation

In the United States, section 351(i)(1) of the Public Health Service Act, or PHSA, defines a biological

product (biologic) as a:

•

“virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic
product, protein (except any chemically synthesized polypeptide), or analogous product, … applicable
to the prevention, treatment, or cure of a disease or condition of human beings.”

The information that must be submitted to the FDA in order to obtain approval to market a new biologic

varies depending on whether the application for the biological product is submitted under section 351(a) or
section 351(k) of the PHSA. Any proposed biologic, including a new product whose safety, purity and potency
has not previously been demonstrated in humans, may follow the Biologics License Application, or BLA, route
as defined by section 351(a). However, a proposed biologic whose active ingredient(s) and certain other
properties are highly similar (biosimilar) to those of a previously approved biologic may follow an abbreviated
licensure pathway as defined by section 351(k) of the PHSA. The FDA, under the authority of the Secretary of
Health and Human Services, reviews and ultimately approves applications for biological products submitted
under either pathway.

In addition, in the FDA’s 2015 guidance document “Biosimilars: Questions and Answers Regarding
Implementation of the Biologics Price Competition and Innovation Act of 2009,” the FDA clarified that it
intends to regulate any polymer composed of 40 or fewer amino acids, and any polymer made entirely by
chemical synthesis and composed of fewer than 100 amino acids, as drugs under the Federal Food, Drug, and
Cosmetic Act, or FFDCA, and its implementing regulations, rather than as biologics under the PHSA, unless the
polymer otherwise meets the statutory definition of a biological product. The process required by the FDA before
a drug may be marketed in the United States generally involves the submission to the FDA of a New Drug
Application, or NDA. The results of preclinical studies and clinical trials, along with information regarding the
manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling and other
relevant information are submitted to the FDA as part of an NDA, and FDA review and approval of the NDA is
necessary prior to any commercial marketing or sale of the drug in the United States. However, under the Hatch-
Waxman Act, a pharmaceutical manufacturer may file an abbreviated new drug application, or ANDA, seeking
approval of a generic copy of an approved branded product. Additionally, a pharmaceutical manufacturer may,
under Section 505(b)(2) of the FFDCA, file an NDA that relies on studies not conducted by the applicant, or for
which the applicant has not obtained a right of reference.

Drugs and biologics are also subject to other federal, state, and local statutes and regulation. If we fail to
comply with applicable FDA or other requirements at any time during the drug development process, clinical
testing, approval process or post-approval activities, we may become subject to administrative or judicial
sanctions. These sanctions could include the FDA’s refusal to approve pending applications, license suspension
or revocation, withdrawal of an approval, warning letters, product recalls, product seizures, total or partial
suspension of production or distribution, injunctions, fines, civil penalties or criminal prosecution. Any FDA
enforcement action could have a material adverse effect on us.

BLA/NDA Approval Process

The process generally required by the FDA before a biologic or drug product candidate may be marketed in

the United States involves the following:

•

completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s
current GLP regulations;

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•

•

•

•

•

•

•

•

submission to the FDA of an IND which must become effective before human clinical trials may begin
and must be updated annually;

approval by an independent institutional review board, or IRB, or ethics committee at each clinical site
before the trial is initiated;

performance of adequate and well-controlled clinical trials to establish the safety, purity and potency of
the proposed biologic, and the safety and efficacy of the proposed drug for each indication;

preparation of and submission to the FDA of a BLA or NDA after successful completion of all pivotal
clinical trials;

satisfactory completion of an FDA Advisory Committee review, if applicable;

a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for
substantive review;

satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at
which the proposed product is produced to assess compliance with cGMP and to assure that the
facilities, methods and controls are adequate to preserve the biological product’s continued safety,
purity and potency; and

FDA review and approval of the BLA or NDA prior to any commercial marketing or sale of the
biologic product in the United States.

The preclinical and clinical testing and approval process requires substantial time, effort, and financial

resources, and we cannot be certain that any approvals for our product candidates will be granted on a timely
basis, if at all. An IND is a request for authorization from the FDA to administer an investigational new drug
product to humans. The central focus of an IND submission is on the general investigational plan and the
protocol(s) for human studies. The IND also includes results of animal and in vitro studies assessing the
toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry,
manufacturing, and controls information; and any available human data or literature to support the use of the
investigational product. An IND must become effective before human clinical trials may begin. An IND will
automatically become effective 30 days after receipt by the FDA, unless before that time the FDA raises
concerns or questions related to the proposed clinical studies. In such a case, the IND may be placed on clinical
hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before clinical
studies can begin. Accordingly, submission of an IND may or may not result in the FDA allowing clinical studies
to commence.

Clinical trials involve the administration of the investigational product to human subjects under the
supervision of qualified investigators in accordance with current Good Clinical Practices, or cGCPs, which
include the requirement that all research subjects provide their informed consent for their participation in any
clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the
study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Each clinical
protocol and any subsequent protocol amendments must be submitted to the FDA as part of the IND, and an IRB
at each site where the study is conducted must also approve the study. The IRB must monitor the study until
completed. There are also requirements governing the reporting of ongoing clinical studies and clinical study
results to public registries. Clinical trials typically are conducted in three or four sequential phases, but the phases
may overlap or be combined.

•

•

Phase 1. The investigational product is initially introduced into healthy human subjects or patients with
the target disease or condition. These studies are designed to evaluate the safety, dosage tolerance,
metabolism and pharmacologic actions of the investigational product in humans, the side effects
associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

Phase 2. The investigational product is administered to a limited patient population to evaluate dosage
tolerance and optimal dosage, identify possible adverse side effects and safety risks, and preliminarily
evaluate efficacy.

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•

•

Phase 3. The investigational product is administered to an expanded patient population, generally at
geographically dispersed clinical study sites to generate enough data to statistically evaluate dosage,
clinical effectiveness and safety, to establish the overall benefit-risk relationship of the investigational
product, and to provide an adequate basis for product labeling and approval.

Phase 4. In some cases, the FDA may condition approval of an NDA or BLA for a product candidate
on the sponsor’s agreement to conduct additional clinical studies after approval. In other cases, a
sponsor may voluntarily conduct additional clinical studies after approval to gain more information
about the product. Such post-approval studies are typically referred to as Phase 4 clinical trials.

A pivotal trial is a clinical study that is designed to generate substantial evidence of product’s safety and

efficacy that adequately meets regulatory agency requirements to justify the approval of the product. Generally,
pivotal trials are Phase 3 trials, but the FDA may accept results from Phase 2 trials if the trial design provides a
well-controlled and reliable assessment of clinical benefit, particularly in situations where there is an unmet
medical need and the results are sufficiently robust.

Phase 1, Phase 2 and Phase 3 trials may not be completed successfully within a specified period, if at all,

and there can be no assurance that the data collected will support FDA approval or licensure of the product.
Furthermore, the FDA, the IRB, or the clinical study sponsor may suspend or terminate a clinical study at any
time on various grounds, including a finding that the research subjects are being exposed to an unacceptable
health risk. Additionally, some clinical studies are overseen by an independent group of qualified experts
organized by the clinical study sponsor, known as a data safety monitoring board or committee. This group
provides authorization for whether or not a trial may move forward at designated check points based on access to
certain data from the trial. We may also suspend or terminate a clinical study based on evolving business
objectives and/or competitive climate.

Assuming successful completion of all required testing in accordance with all applicable regulatory
requirements, detailed information regarding the investigational product is submitted to the FDA in the form of
an NDA or BLA requesting approval to market the product for one or more indications. The NDA or BLA must
include all relevant data available from pertinent preclinical and clinical trials, including negative or ambiguous
results as well as positive findings, together with detailed information relating to the product’s chemistry,
manufacturing, controls, and proposed labeling, among other things. Data can come from company-sponsored
clinical studies intended to test the safety and effectiveness of a use of the product, or from a number of
alternative sources, including studies initiated by investigators. Under federal law, the submission of most NDAs
and BLAs is subject to an application user fee, and the sponsor of an approved NDA or BLA is also subject to
annual product and establishment user fees. These fees are typically increased annually. A waiver of user fees
may be obtained under certain limited circumstances.

Once an NDA or BLA has been submitted, the FDA’s goal is to review the application within ten months
after it accepts the application for filing, or, if the application relates to an unmet medical need in a serious or
life-threatening indication, six months after the FDA accepts the application for filing. The review process is
often significantly extended by FDA requests for additional information or clarification. The FDA reviews a
BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is
manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety,
purity and potency. Similarly, the FDA reviews an NDA to determine, among other things, whether the proposed
product is safe and effective for its intended use, and whether the product is being manufactured in accordance
with cGMP to assure and preserve the product’s quality and purity.

Before approving a BLA or NDA, the FDA typically will inspect the facility or facilities at which the
product is manufactured. The FDA will not approve the application unless it determines that the manufacturing
processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production
of the product within required specifications. Additionally, before approving a BLA or NDA, the FDA will

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typically inspect one or more clinical sites to assure compliance with cGCP. If the FDA determines that the
application, clinical data, manufacturing process or manufacturing facilities are not acceptable, it will outline the
deficiencies in the submission and often will request additional testing or information. Notwithstanding the
submission of any requested additional information, the FDA ultimately may decide that the application does not
satisfy the regulatory criteria for approval.

The FDA is required to refer an application for a novel product to an advisory committee or explain why

such referral was not made. Typically, an advisory committee is a panel of independent experts, including
clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the
application should be approved and under what conditions. The FDA is not bound by the recommendations of an
advisory committee, but it considers such recommendations carefully when making decisions.

The testing and approval process requires substantial time, effort and financial resources, and each may take

several years to complete. The FDA may not grant approval on a timely basis, or at all, and we and our partners
may encounter difficulties or unanticipated costs in our efforts to secure necessary governmental approvals,
which could delay or preclude us from marketing our products. After the FDA evaluates a BLA or NDA and
conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will
be produced, the FDA may issue an approval letter or a Complete Response Letter. An approval letter authorizes
commercial marketing of the product with specific prescribing information for specific indications. A Complete
Response Letter indicates that the review cycle of the application is complete and the application is not ready for
approval. A Complete Response Letter may require additional clinical data and/or an additional pivotal Phase 3
trial or trials, and/or other significant, expensive and time-consuming requirements related to clinical trials,
preclinical trials or manufacturing. Even if such additional information is submitted, the FDA may ultimately
decide that the BLA or NDA does not satisfy the criteria for approval. The FDA may also approve the BLA or
NDA with a Risk Evaluation and Mitigation Strategy, or REMS, plan to mitigate risks, which could include
medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution
methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among
other things, changes to proposed labeling, development of adequate controls and specifications, or a
commitment to conduct one or more post-market studies or clinical trials. Such post-market testing may include
Phase 4 trials and surveillance to further assess and monitor the product’s safety and effectiveness after
commercialization. New government requirements, including those resulting from new legislation, may be
established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products
under development.

Drugs and biologics manufactured or distributed pursuant to FDA approvals are subject to pervasive and

continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping,
periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse
experiences with the product. After approval, most changes to the approved product, such as adding new
indications or other labeling claims are subject to prior FDA review and approval. There also are continuing,
annual user fee requirements for any marketed products and the establishments at which such products are
manufactured, as well as new application fees for supplemental applications with clinical data. Manufacturers are
subject to periodic unannounced inspections by the FDA and state agencies for compliance with cGMP
requirements. Changes to the manufacturing process are strictly regulated, and, depending on the significance of
the change, may require prior FDA approval before being implemented. FDA regulations also require
investigation and correction of any deviations from cGMP and impose reporting and documentation requirements
upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue
to expend time, money and effort in the area of production and quality control to maintain compliance with
cGMP and other aspects of regulatory compliance.

We rely, and expect to continue to rely, on third parties for the production of clinical quantities of our
product candidates, and expect to rely in the future on third parties for the production of commercial quantities.
Future FDA and state inspections may identify compliance issues at our facilities or at the facilities of our

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contract manufacturers that may disrupt production or distribution, or require substantial resources to correct. In
addition, discovery of previously unknown problems with a product or the failure to comply with applicable
requirements may result in restrictions on a product, manufacturer or holder of an approved NDA or BLA,
including withdrawal or recall of the product from the market or other voluntary, FDA-initiated or judicial action
that could delay or prohibit further marketing.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not
maintained or if problems occur after the product reaches the market. Later discovery of previously unknown
problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing
processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to
add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or
imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences
include, among other things:

•

•

•

•

•

restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from
the market or product recalls;

adverse publicity, fines, warning letters or holds on post-approval clinical trials;

refusal of the FDA to approve pending applications or supplements to approved applications, or
suspension or revocation of product license approvals;

product seizure or detention, or refusal to permit the import or export of products; or

injunctions or the imposition of civil or criminal penalties.

The FDA strictly regulates marketing, labeling, advertising, and promotion of products that are placed on
the market. Drugs and biologics may be promoted only for the approved indications and in accordance with the
provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations
prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label
uses may be subject to significant enforcement action and liability.

Abbreviated Licensure Pathway of Biological Products as Biosimilar or Interchangeable

The Patient Protection and Affordable Care Act, or PPACA, or Affordable Care Act, or ACA, signed into
law on March 23, 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, or
BPCIA, which amended the PHSA and created an abbreviated approval pathway for biological products shown
to be highly similar to an FDA-licensed reference biological product. The BPCIA attempts to minimize
duplicative testing, and thereby lower development costs and increase patient access to affordable treatments. An
application for licensure of a biosimilar product under section 351(k) of the PHSA must include information
demonstrating biosimilarity based upon the following, unless the FDA determines otherwise:

•

•

•

analytical studies demonstrating that the proposed biosimilar product is highly similar to the approved
product notwithstanding minor differences in clinically inactive components;

animal studies (including the assessment of toxicity); and

a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or
pharmacodynamics) sufficient to demonstrate safety, purity and potency in one or more conditions for
which the reference biologic product is licensed and intended to be used.

In addition, an application submitted under the 351(k) pathway must include information demonstrating that:

•

the proposed biosimilar product and reference product utilize the same mechanism of action for the
condition(s) of use prescribed, recommended, or suggested in the proposed labeling, but only to the
extent the mechanism(s) of action are known for the reference product;

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•

•

•

the condition or conditions of use prescribed, recommended, or suggested in the labeling for the
proposed biosimilar product have been previously approved for the reference product;

the route of administration, the dosage form, and the strength of the proposed biosimilar product are the
same as those for the reference product; and

the facility in which the biological product is manufactured, processed, packed and held meets
standards designed to assure that the biological product continues to be safe, pure, and potent.

Biosimilarity, as defined in PHSA §351(i), means that the biological product is highly similar to the
reference product notwithstanding minor differences in clinically inactive components; and that there are no
clinically meaningful differences between the biological product and the reference product in terms of the safety,
purity, and potency of the product.

In addition, section 351(k)(4) of the PHSA provides for a designation of “interchangeability” between the
reference and biosimilar products, whereby the biosimilar may be substituted for the reference product without
the intervention of the health care provider who prescribed the reference product. To date, the FDA has not
approved any biosimilar product as being interchangeable to the reference product. The higher standard of
interchangeability must be demonstrated by information sufficient to show that:

•

•

•

the proposed product is biosimilar to the reference product;

the proposed product is expected to produce the same clinical result as the reference product in any
given patient; and

for a product that is administered more than once to an individual, the risk to the patient in terms of
safety or diminished efficacy of alternating or switching between the biosimilar and the reference
product is no greater than the risk of using the reference product without such alternation or switch.

FDA approval is required before a biosimilar may be marketed in the United States. However, complexities

associated with the large and intricate structures of biological products and the process by which such products
are manufactured pose significant hurdles to the FDA’s implementation of the 351(k) approval pathway that are
still being worked out by the FDA. For example, the FDA has discretion over the kind and amount of scientific
evidence—laboratory, preclinical and/or clinical—required to demonstrate biosimilarity to a licensed biological
product. According to FDA guidance:

“the implementation of an abbreviated licensure pathway for biological products can present challenges

given the scientific and technical complexities that may be associated with the larger and typically more
complex structure of biological products, as well as the processes by which such products are manufactured.
Most biological products are produced in a living system such as a microorganism, or plant or animal cells,
whereas small molecule drugs are typically manufactured through chemical synthesis.”

The FDA intends to consider the totality of the evidence, provided by a sponsor to support a demonstration

of biosimilarity, and recommends that sponsors use a stepwise approach in the development of their biosimilar
products. Biosimilar product applications thus may not be required to duplicate the entirety of preclinical and
clinical testing used to establish the underlying safety and effectiveness of the reference product. However, the
FDA may refuse to approve a biosimilar application if there is insufficient information to show that the active
ingredients are the same or to demonstrate that any impurities or differences in active ingredients do not affect
the safety, purity or potency of the biosimilar product. In addition, as with BLAs, biosimilar product applications
will not be approved unless the product is manufactured in facilities designed to assure and preserve the
biological product’s safety, purity and potency.

The submission of an application via the 351(k) pathway does not guarantee that the FDA will accept the

application for filing and review, as the FDA may refuse to accept applications that it finds are insufficiently
complete. The FDA will treat a biosimilar application or supplement as incomplete if, among other reasons, any

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applicable user fees assessed under the Biosimilar User Fee Act of 2012 have not been paid. In addition, the FDA
may accept an application for filing but deny approval on the basis that the sponsor has not demonstrated
biosimilarity, in which case the sponsor may choose to conduct further analytical, preclinical or clinical studies
and submit a BLA for licensure as a new biological product under section 351(a) of the PHSA.

The timing of final FDA approval of a biosimilar for commercial distribution depends on a variety of

factors, including whether the manufacturer of the branded product is entitled to one or more statutory
exclusivity periods, during which time the FDA is prohibited from approving any products that are biosimilar to
the branded product. The FDA cannot approve a biosimilar application for twelve years from the date of first
licensure of the reference product. Additionally, a biosimilar product sponsor may not submit an application
under the 351(k) pathway for four years from the date of first licensure of the reference product. A reference
product may also be entitled to exclusivity under other statutory provisions. For example, a reference product
designated for a rare disease or condition (an “orphan drug”) may be entitled to seven years of exclusivity under
section 360cc of the FFDCA, in which case no product that is biosimilar to the reference product may be
approved until either the end of the twelve-year period provided under §351(k) or the end of the seven-year
orphan drug exclusivity period, whichever occurs later. In certain circumstances, a regulatory exclusivity period
can extend beyond the life of a patent, and thus block §351(k) applications from being approved on or after the
patent expiration date. In addition, the FDA may under certain circumstances extend the exclusivity period for
the reference product by an additional six months if the FDA requests, and the manufacturer undertakes, studies
on the effect of its product in children, a so-called pediatric extension.

The first biological product determined to be interchangeable with a branded product for any condition of

use is also entitled to a period of exclusivity, during which time the FDA may not determine that another product
is interchangeable with the reference product for any condition of use. This exclusivity period extends until the
earlier of: (1) one year after the first commercial marketing of the first interchangeable product; (2) 18 months
after resolution of a patent infringement suit instituted under 42 U.S.C. § 262(l)(6) against the applicant that
submitted the application for the first interchangeable product, based on a final court decision regarding all of the
patents in the litigation or dismissal of the litigation with or without prejudice; (3) 42 months after approval of
the first interchangeable product, if a patent infringement suit instituted under 42 U.S.C. § 262(l)(6) against the
applicant that submitted the application for the first interchangeable product is still ongoing; or (4) 18 months
after approval of the first interchangeable product if the applicant that submitted the application for the first
interchangeable product has not been sued under 42 U.S.C. § 262(l)(6).

Post Approval Requirements

After obtaining regulatory approval of a product, manufacturers may be required to comply with a number

of post-approval requirements. For example, as a condition of approval of a BLA or a §351(k) application the
FDA may require post marketing testing and surveillance to monitor the product’s safety or efficacy.

In addition, the holder of an approved BLA or §351(k) application is required to timely report certain
adverse reactions and production problems involving its product to the FDA to provide updated safety and
efficacy information and to comply with requirements concerning advertising and promotional labeling for the
product. Quality control and manufacturing procedures must also continue to conform to cGMPs after approval
and the FDA periodically inspects manufacturing facilities to assess compliance with cGMPs.

Patent Disputes under the BPCIA

The BPCIA includes a detailed framework for addressing potential patent disputes between biosimilar
product and reference product sponsors. Within 20 days after being notified that FDA has accepted its application
for review, a 351(k) applicant must provide a copy of its application, along with any other information that
describes the manufacturing processes for the biosimilar product, to the reference product sponsor’s in-house
counsel, the reference product sponsor’s outside counsel, and/or a representative of the owner of a patent

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exclusively licensed to the reference product sponsor with respect to the reference product who has retained a
right to assert the patent or participate in litigation. The copy of the application and any other information
provided are considered “confidential information” under the PHSA, and recipients are generally prohibited from
disclosing anything contained therein and from using the information for any purposes other than to determine
whether a patent infringement claim may reasonably be asserted. The reference product sponsor then has sixty
days to provide the applicant with an initial list of patents that could reasonably be asserted. The reference
product sponsor may also choose to designate patents that it would be willing to license to the applicant.

Within sixty days of receiving the initial list of patents from the reference product sponsor, the biosimilar

applicant may provide the reference product sponsor with an initial list of patents that the applicant contends
could reasonably be asserted by the reference product sponsor, and, for each patent on this list or the list provided
by the reference product sponsor, must either (1) provide a claim-by-claim statement of the factual and legal
basis for the applicant’s opinion that the patent is invalid, unenforceable, or will not be infringed, or (2) provide a
statement that the applicant does not intend to begin marketing its product prior to the patent’s expiration. The
applicant must also respond to the reference product sponsor’s list of patents available for licensing. If the
applicant provided any statement regarding the non-infringement, invalidity, or unenforceability of any of the
patents-at-issue, the reference product sponsor has sixty days to rebut such arguments and to provide the factual
and legal basis for the reference product sponsor’s option that the patent(s) will be infringed by the commercial
marketing of the proposed biosimilar product.

Once the applicant has received the statement of the basis for the reference product sponsor’s opinion, the
parties have fifteen days to engage in good faith negotiations to agree on which if any of the patents will be the
subject of an infringement action. The PHSA contemplates that the parties may not reach an agreement within
this timeframe, in which case additional patent list exchange procedures are triggered. The applicant must first
notify the reference product sponsor of the number of patents that it believes should be the subject of an
infringement action. Subsequently, within five days of this notification and on a date agreed upon by the parties,
the parties must simultaneously exchange lists of the patents that each believes should be the subject of an
infringement action. The reference product sponsor may not list a greater number of patents than the number
listed by the applicant, though if the applicant lists no patents the reference product sponsor may still list just one.
Under this provision, the biosimilar applicant thus controls the number of patents that will be the subject of the
infringement action.

Following this last list exchange, the reference product sponsor has thirty days to bring an infringement
action for each patent on both lists. Alternatively, if the parties successfully negotiate an agreement regarding the
patents that will form the basis for an infringement action, the reference product sponsor has thirty days after
such agreement to bring an infringement action for each of the negotiated patents. Within thirty days of being
served with a complaint in the infringement action, the applicant must provide notice to the FDA, and the FDA
will publish notice of the complaint in the Federal Register. Unlike the Hatch-Waxman Act, under which a
reference product sponsor must list its patents in the Orange Book, and the FDA will suspend its review for thirty
months if a reference product sponsor files a patent infringement suit, the BPCIA does not direct the FDA to
suspend review of the biosimilar product application as a result of the patent dispute.

For patents that are issued or licensed after the reference product sponsor has identified its initial list, the
reference product sponsor may supplement its initial list with the additional patents within thirty days of the new
patents’ issuance or licensing. The biosimilar applicant must then respond within thirty days with a statement of
the factual and legal basis for its opinion that the patent is invalid, unenforceable, or will not be infringed, or that
the applicant does not intend to begin marketing its product prior to the patent’s expiration. However, these
patents do not become subject to the additional negotiation and list exchange procedures of the BPCIA, but rather
are subject to preliminary injunction (PI) procedures. The BPCIA requires the biosimilar applicant to provide 180
day notice to the reference product sponsor of the applicant’s intent to market the biosimilar product, and the
reference product sponsor may then seek a PI on any patents there were included on any of the patent lists
initially exchanged between the parties, but excluded from the patent list agreed to during negotiations or from

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the lists that were exchanged as a result of the parties’ failure to reach an agreement. Both parties must
reasonably cooperate to expedite discovery as is needed in connection with the PI motion.

The BPCIA limits both the reference product sponsor and the biosimilar applicant from bringing actions for

declaratory judgment (DJ). In particular, if the reference product sponsor has been provided confidential access
to the biosimilar application, neither party may bring a DJ action before the reference product sponsor receives
the applicant’s 180 day advance notice of commercial marketing. Moreover, DJ actions may only be brought
against patents for which a PI motion has been filed. Importantly, if the biosimilar applicant fails to respond to
the reference product sponsor as required at the various steps of the BPCIA’s patent dispute resolution
framework, the reference product sponsor may bring a DJ action on any patent included on the reference product
sponsor’s initial list and its list of newly issued or licensed patents. If the applicant fails to provide access to the
confidential information required to be provided at the start of the patent dispute process, the reference product
sponsor may bring a DJ action on any patent that claims the biological product or its use.

The FDA has approved four applications submitted under the 351(k) pathway through December 31, 2016:
Zarxio (filgrastim-sndz) on March 6, 2015, Inflectra (infliximab-dyyb) on April 5, 2016, Erelzi (etanercept-szzs)
on August 30, 2016 and Amjevita (adalimumab-atto) on September 23, 2016. Thus, no typical review period for
a biosimilar application has yet been established. However, the FDA aims to review 70%, 80%, 85%, and 90% of
original (rather than resubmitted) biosimilar applications within ten months of receipt in fiscal years 2014, 2015,
2016, and 2017 respectively. The FDA did complete review of the Zarxio application within 10 months of a BLA
filing (May 8, 2014). While it may be possible for a biosimilar applicant and reference product sponsor to settle
any patent disputes prior to approval, patent litigation may delay the ability of a biosimilar applicant to sell
commercial product in the United States, as was the case with Zarxio, which was launched in September 2015.

505(b)(2) New Drug Applications

The provisions of Section 505(b)(2) of the FFDCA were created, in part, to help avoid unnecessary
duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section
gives the FDA express permission to rely on data not developed by the NDA applicant. Indeed, a new drug
application filed under Section 505(b)(2) is one for which one or more of the investigations relied upon by the
applicant for approval were not conducted by or for the applicant and for which the applicant has not obtained a
right of reference or use from the person by or for whom the investigations were conducted. We are pursuing a
Section 505(b)(2) regulatory strategy for our PF708 product candidate and we plan to reference the Forteo
(teriparatide) listed drug which is marketed by Eli Lilly for the treatment of osteoporosis.

The owner of an NDA for a branded drug product may list with the FDA certain patents whose claims
allegedly cover the applicant’s branded product. Each of the patents listed in the application for the drug is then
published in the Orange Book. Any applicant who files a 505(b)(2) new drug application referencing a drug
listed in the Orange Book must certify to the FDA that: (1) no patent information on the drug product that is the
subject of the application has been submitted to the FDA, referred to as a Paragraph I Certification; (2) such
patent has expired, referred to as a Paragraph II Certification; (3) the date on which such patent expires, referred
to as a Paragraph III Certification; or (4) such patent is invalid or will not be infringed upon by the manufacture,
use or sale of the drug product for which the application is submitted, referred to as a Paragraph IV Certification.
The applicant may also elect to submit a “section viii” statement certifying that its proposed label does not
contain, or carves out, any language regarding the patented method-of-use rather than certify to a listed method-
of-use patent. An applicant submitting a Paragraph IV Certification must provide notice to each owner of the
patent that is the subject of the certification and to the holder of the approved branded drug to which the
505(b)(2) application refers. If the reference branded drug holder and patent owners assert a patent challenge
directed to one of the Orange Book listed patents within 45 days of the receipt of the Paragraph IV Certification
notice, the FDA is prohibited from approving the 505(b)(2) application until the earlier of 30 months from the
receipt of the Paragraph IV Certification, expiration of the patent, settlement of the lawsuit, or a decision in the
infringement case that is favorable to the applicant.

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Additionally, a 505(b)(2) application also will not be approved until any applicable non-patent exclusivity
listed in the Orange Book for the NDA branded reference drug has expired as described in further detail below.
Market and data exclusivity provisions under the FFDCA can delay the submission or the approval of certain
applications for competing products. In addition to patent exclusivity, the holder of the NDA for a reference
listed drug may be entitled to a period of non-patent exclusivity, during which the FDA cannot approve another
drug application that relies on the listed drug. For example, a pharmaceutical manufacturer may obtain five years
of non-patent exclusivity upon NDA approval of a new chemical entity, or NCE, which is a drug that contains an
active moiety that has not been approved by the FDA in any other NDA. An “active moiety” is defined as the
molecule or ion responsible for the drug substance’s physiological or pharmacologic action. During the five-year
exclusivity period, the FDA cannot accept for filing any application for the same active moiety and that relies on
the FDA’s findings regarding that drug; the FDA may accept an application for filing after four years if the
follow-on applicant makes a Paragraph IV Certification. A drug may obtain a three-year period of exclusivity for
a particular condition of approval, or change to a marketed product, such as a new formulation for a previously
approved product, if one or more new clinical trials, other than bioavailability or bioequivalence studies, was
essential to the approval of the application and was conducted or sponsored by the applicant. Should this occur,
the FDA would be precluded from approving any ANDA that references such product until after that three-year
exclusivity period has run. However, unlike NCE exclusivity, the FDA can accept an application and begin the
review process during the entire exclusivity period.

Patent Term Restoration

Depending upon the timing, duration, and specifics of the FDA approval of the use of our product
candidates, some of our U.S. patents may be eligible for limited patent term extension under the Drug Price
Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman
Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as
compensation for patent term lost during product development and the FDA regulatory review process. However,
patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the
product’s approval date. The patent term restoration period is generally half the time between the effective date
of an IND and the submission date of an NDA or BLA, plus the time between the submission date and the
approval of that application. Only one patent applicable to an approved product is eligible for the extension and
the application for the extension must be submitted prior to the expiration of the patent. The U.S. Patent and
Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term
extension or restoration. In the future, we may apply for restoration of patent term for one of our currently owned
or licensed patents to add patent life beyond its current expiration date, depending on the expected length of the
clinical studies and other factors involved in the filing of the relevant NDA or BLA.

The Animal Rule

In the case of product candidates that are intended to treat certain rare life-threatening diseases, such as our
anthrax vaccine product candidates, conducting controlled clinical trials to determine efficacy may be unethical
or unfeasible. Under regulations issued by the FDA in 2015, often referred to as the “Animal Rule,” the approval
of such products can be based on clinical data from trials in healthy human subjects that demonstrate adequate
safety and efficacy data from adequate and well-controlled animal studies. Among other requirements, the animal
studies must establish that the drug or biological product is reasonably likely to produce clinical benefits in
humans. Because the FDA must agree that data derived from animal studies may be extrapolated to establish
safety and effectiveness in humans, seeking approval under the Animal Rule may add significant time,
complexity and uncertainty to the testing and approval process. In addition, products approved under the Animal
Rule are subject to additional requirements including post-marketing study requirements, restrictions imposed on
marketing or distribution or requirements to provide information to patients.

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Pharmaceutical Coverage, Pricing and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any products for which we

obtain regulatory approval. In the United States and markets in other countries, sales of any products for which
we receive regulatory approval for commercial sale will depend in part on the availability of coverage and
reimbursement from third-party payors. Third-party payors include government authorities, managed care
providers, private health insurers and other organizations. The process for determining whether a payor will
provide coverage for a drug product may be separate from the process for setting the reimbursement rate that the
payor will pay for the drug product. Third-party payors may limit coverage to specific drug products on an
approved list, or formulary, which might not include all of the FDA-approved drugs for a particular indication.
Moreover, a payor’s decision to provide coverage for a drug product does not imply that an adequate
reimbursement rate will be approved. Adequate third-party reimbursement may not be available to enable us to
maintain price levels sufficient to realize an appropriate return on our investment in product development.

Third-party payors are increasingly challenging the price and examining the medical necessity and cost-

effectiveness of medical products and services, in addition to their safety and efficacy. In order to obtain
coverage and reimbursement for any product that might be approved for sale, we may need to conduct expensive
pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products,
in addition to the costs required to obtain regulatory approvals. Our product candidates may not be considered
medically necessary or cost-effective. If third-party payors do not consider a product to be cost-effective
compared to other available therapies, they may not cover the product after approval as a benefit under their
plans or, if they do, the level of payment may not be sufficient to allow a company to sell its products at a profit.

The United States government, state legislatures and foreign governments have shown significant interest in

implementing cost containment programs to limit the growth of government-paid health care costs, including
price controls, restrictions on reimbursement and requirements for substitution of therapeutic equivalent products
for branded prescription drugs. By way of example, the Patient Protection and Affordable Care Act, as amended
by the Health Care and Education Reconciliation Act, collectively, Affordable Care Act, contains provisions that
may reduce the profitability of drug products, including, for example, increased the minimum rebates owed by
manufacturers under the Medicaid Drug Rebate Program, extended the rebate program to individuals enrolled in
Medicaid managed care plans, addressed a new methodology by which rebates owed by manufacturers under the
Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected,
established mandatory discounts for certain Medicare Part D beneficiaries and annual fees based on
pharmaceutical companies’ share of sales to federal health care programs. Furthermore, the current presidential
administration and Congress are also expected to attempt broad sweeping changes to the current health care laws.
We face uncertainties that might result from modification or repeal of any of the provisions of the Affordable
Care Act, including as a result of current and future executive orders and legislative actions. The impact of those
changes on us and potential effect on biosimilar manufacturers as a whole is currently unknown. But, any
changes to the Affordable Care Act are likely to have an impact on our results of operations, and may have a
material adverse effect on our results of operations. We cannot predict what other healthcare programs and
regulations will ultimately be implemented at the federal or state level or the effect of any future legislation or
regulations in the United States may have on our business.

In the European Union, governments influence the price of pharmaceutical products through their pricing
and reimbursement rules and control of national health care systems that fund a large part of the cost of those
products to consumers. Some jurisdictions operate positive and negative list systems under which products may
only be marketed once a reimbursement price has been agreed to by the government. To obtain reimbursement or
pricing approval, some of these countries may require the completion of clinical studies that compare the cost-
effectiveness of a particular product candidate to currently available therapies. Other member states allow
companies to fix their own prices for medicines, but monitor and control company profits. The downward
pressure on health care costs in general, particularly prescription drugs, has become very intense. As a result,
increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-
border imports from low-priced markets exert a commercial pressure on pricing within a country.

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The marketability of any products for which we and our collaboration partners receive regulatory approval
for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and
reimbursement. In addition, an increasing emphasis on cost containment measures in the United States and other
countries has increased and we expect will continue to increase the pressure on pharmaceutical pricing. Coverage
policies and third-party reimbursement rates may change at any time. Even if favorable coverage and
reimbursement status is attained for one or more products for which we receive regulatory approval, less
favorable coverage policies and reimbursement rates may be implemented in the future.

Other Healthcare Laws and Compliance Requirements

If we and our collaboration partners obtain regulatory approval for any of our product candidates, we may
be subject to various federal and state laws targeting fraud and abuse in the healthcare industry. These laws may
impact, among other things, our proposed sales, marketing and education programs. In addition, we may be
subject to patient privacy regulation by both the federal government and the states in which we conduct our
business. The laws that may affect our ability to operate include:

• The federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and
willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in
return for, the purchase or recommendation of an item or service reimbursable under a federal
healthcare program, such as the Medicare and Medicaid programs;

•

Federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among
other things, individuals or entities from knowingly presenting, or causing to be presented, claims for
payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;

• The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created
new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit
program and making false statements relating to healthcare matters;

• The federal transparency laws, including the federal Physician Payment Sunshine Act, that requires
drug manufacturers to disclose payments and other transfers of value provided to physicians and
teaching hospitals and ownership and investment interests held by such physicians and their immediate
family members;

• HIPAA, as amended by the Health Information Technology and Clinical Health Act, or HITECH, and
its implementing regulations, which imposes certain requirements relating to the privacy, security and
transmission of individually identifiable health information; and

•

State law equivalents of each of the above federal laws, such as anti-kickback and false claims laws
which may apply to items or services reimbursed by any third-party payor, including commercial
insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical
industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the
federal government, or otherwise restrict payments that may be made to healthcare providers and other
potential referral sources; state laws that require drug manufacturers to report information related to
payments and other transfers of value to physicians and other healthcare providers or marketing
expenditures; and state laws governing the privacy and security of health information in certain
circumstances, many of which differ from each other in significant ways and may not have the same
effect, thus complicating compliance efforts.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors

available, it is possible that some of our future business activities could be subject to challenge under one or more
of such laws. In addition, the Affordable Care Act broadened the reach of the fraud and abuse laws by, among
other things, amending the intent requirement of the federal Anti-Kickback Statute and certain criminal
healthcare fraud statutes. Pursuant to the statutory amendment, a person or entity no longer needs to have actual
knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, the

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Affordable Care Act provides that the government may assert that a claim including items or services resulting
from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the
False Claims Act, or FCA, (discussed below) or the civil monetary penalties statute.

We are also subject to the Foreign Corrupt Practices Act, or FCPA, which prohibits improper payments or
offers of payments to foreign governments and their officials for the purpose of obtaining or retaining business.
Safeguards we implement to discourage improper payments or offers of payments by our employees, consultants,
and others may be ineffective, and violations of the FCPA and similar laws may result in severe criminal or civil
sanctions, or other liabilities or proceedings against us, any of which would likely harm our reputation, business,
financial condition and result of operations.

If our operations are found to be in violation of any of the laws described above or any other governmental

regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, exclusion from
participation in government healthcare programs, such as Medicare and Medicaid and imprisonment, damages,
fines and the curtailment or restructuring of our operations, any of which could adversely affect our ability to
operate our business and our results of operations.

Hazardous Materials

Our research and development processes may involve the controlled use of hazardous materials and
chemicals. We are subject to federal, state and local laws and regulations governing the use, manufacture,
storage, handling and disposal of hazardous materials and waste products. We cannot predict how changes in
laws or development of new regulations will affect our business operations or the cost of compliance.

Competition

The development and commercialization of protein therapeutics is highly competitive. While we believe

that our Pfe¯nex Expression Technology®, knowledge, experience and scientific resources provide us with
competitive advantages, we face potential competition from many different sources, including major
pharmaceutical, generic pharmaceutical, specialty pharmaceutical and biotechnology companies. In the event that
we and our collaboration partners were to market and sell any of our biopharmaceutical products, we would face
competition from the companies producing branded reference drugs, as well as any other firms developing the
biosimilars that would compete with the product candidates in our pipeline and other novel products with similar
indications. For example, PF582 may compete with products by Roche, as the reference product sponsor, Sandoz
International GmbH, or Sandoz, a subsidiary of Novartis AG, Formycon AG, and bioeq GmbH as biosimilar
companies and Ophthotech Corporation as a developer of novel products. Additionally, PF582 and Lucentis
compete with globally marketed products including Eylea and Avastin (off label). Similarly, PF708, our
teriparatide 505(b)(2) candidate, may face competition from the reference product sponsor, Eli Lilly, or other
competition from companies like Teva and Gedeon Richter Plc., and from Amgen Inc. and Radius Health, Inc. as
developers of novel products. Key competitive factors affecting the success of our lead product candidates, if
approved, are likely to be price, the level of biosimilar, therapeutic equivalent and novel product competition and
the availability of coverage and reimbursement from government and other third-party payors.

Similarly, our novel vaccine development programs face substantial competition from major pharmaceutical

and other biotechnology companies that are actively working on improved and novel vaccines. We believe that
our primary competitors include Emergent BioSolutions, Inc. and Altimmune, Inc. These companies are
receiving funding from BARDA for the development of next generation anthrax vaccines. All of our novel
vaccine efforts will face competition for limited government funding from other non-vaccine defensive measures
as well, including medical countermeasures for biological, chemical and nuclear threats, diagnostic testing
systems and other emergency preparedness countermeasures.

Further, many of our competitors, either alone or with their strategic partners, have substantially greater
financial, technical and human resources than we do and significantly greater experience in the discovery and

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development of product candidates, obtaining FDA and other regulatory approvals of treatments and
commercializing those treatments. Accordingly, our competitors may be more successful than we are in
obtaining approval for treatments and achieving widespread market acceptance. Our competitors’ treatments may
be more effective or more effectively marketed and sold than any treatment we may commercialize and may
render our treatments obsolete or non-competitive before we can recover the expenses of developing and
commercializing any of our product candidates.

Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more
resources being concentrated among a smaller number of our competitors. These competitors also compete with
us in recruiting and retaining qualified scientific and management personnel and establishing clinical study sites
and subject registration for clinical studies, as well as in acquiring technologies complementary to or necessary
for our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly
through collaborative arrangements with large and established companies.

Sales and Marketing

To date, none of our product candidates have completed clinical development, been submitted for regulatory

review or received marketing authorization from any regulatory agency, and therefore we have not received
revenue from the sale of any of our product candidates.

In light of our stage of development, we have not yet established commercial organization or distribution

capabilities. Except for our agreements with Jazz and Strides Arcolab with respect to certain product candidates,
we generally expect to retain commercial rights for our product candidates. In particular, we intend to use an
internal sales force to commercialize products for which we may receive marketing approvals in territories in
which we believe it is possible to access the market through a focused, specialty sales force.

Upon marketing approval, Jazz, our collaboration partner, will assume responsibility for the manufacturing

and commercialization of certain hematology products globally. For products being developed as part of our joint
venture with Strides Arcolab, we have joint responsibility for worldwide commercialization. Given the initial
emerging markets focus for those products, we generally expect to jointly seek collaboration, distribution and/or
marketing arrangements with third parties.

We have sales and marketing capabilities to support our commercial efforts for our protein production
services and reagent protein product sales. In addition, we have sales and marketing capabilities to support those
products under development that receive FDA approval that will ultimately be procured by the United States
government.

Intellectual Property

We strive to protect and enhance the proprietary technologies that we believe are important to our business,
and seek to obtain and maintain patents for any patentable aspects of our platform technology and our products or
product candidates, their methods of use and any other inventions that are important to the development of our
business. Our success depends substantially on our ability to obtain and maintain patent and other proprietary
protection for our technology and product candidates, to defend and enforce our patents to prevent others from
infringing our proprietary rights, maintain our licenses to use intellectual property owned by third parties,
preserve the confidentiality of our trade secrets and to operate without infringing on the valid and enforceable
patents and other proprietary rights of third parties. Our policy is to seek to protect our proprietary position by,
among other methods, filing United States and foreign patent applications related to our proprietary technology
and product candidates that are important to the development of our business. We also rely on trade secrets,
know-how, continuing technological innovation and in-licensing opportunities to develop and maintain our
proprietary position relating to our platform technology and product candidates.

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We are the owner or licensee of a portfolio of patents and patent applications and possess substantial know-
how and trade secrets which protect various aspects of our business. As of December 31, 2016, we were the sole
owner of a patent portfolio that consisted of a total of 18 U.S. issued patents and six U.S. pending patent
applications that provide material coverage for our platform technology and our lead product candidates as well
as foreign granted and pending patent applications which are counterparts to certain of the foregoing U.S. patents
and patent applications. Our U.S. issued patents expire during the time period beginning in 2025 and ending in
2033. Our owned and exclusively licensed patent portfolio includes claims directed to:

• methods for bacterial protein production and methods for rapid screening of an array of expression

systems

• P. fluorescens promoter sequences and secretion leader sequences

•

•

•

•

auxotrophic marker systems for antibiotic free maintenance of expression plasmids in high cell density
cultures,

improved incorporation of non-natural amino acids

expression of classes of proteins such as cytokines

antibody derivatives

• microbial toxins in P. fluorescens

• methods and expression strains for production and/or purification of soluble full length human

cytokines, Interferon beta and G-CSF

•

•

vaccine antigens recombinant anthrax protective antigen, microbial toxins and toxoids, and the malarial
vaccine candidate antigen P. falciparum circumsporozoite protein (CSP)

fusion partners for peptide production

Pursuant to the technology licensing agreement, The Dow Chemical Company, or TDCC, and Dow Global

Technologies LLC, or DGTI, also grant to us non-exclusive licenses to U.S. patents and applications and their
foreign counterparts covering methods and technologies for recovery of proteins and peptides from
P. fluorescens cells. In conjunction with the licenses granted by TDCC and DGTI to us under the technology
licensing agreement, we also entered into a grant-back and technology license agreement, pursuant to which we
granted to TDCC exclusive and non-exclusive licenses under certain patent rights and know-how relating to our
Pfe¯nex Expression Technology® to use certain biological materials to make, use and commercialize products in
certain fields of use that do not include human therapeutics. See “Business—Collaborations, Joint Development
and Licenses” for a detailed description of our agreements with TDCC and DGTI.

The patent positions of companies like ours are generally uncertain and involve complex legal and factual

questions. Our ability to obtain and maintain our proprietary position for our technology will depend on our
success in obtaining issued claims that cover our technology and product candidates, and being able to enforce
those claims against our competitors once granted. We do not know whether any of our pending patent
applications will result in the issuance of any patents. Moreover, even our issued patents do not guarantee us the
right to practice the patented technology in relation to the commercialization of our product candidates. Third
parties may have blocking patents that could be used to prevent us from commercializing our patented products
and practicing our patented technology. Our issued patents and those that may be issued in the future may be
challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related
products or the length of the term of patent protection that we may have for our products. In addition, the rights
granted under any issued patents may not provide us with proprietary protection or competitive advantages
against competitors with similar technology. Furthermore, our competitors may independently develop similar
technologies. For these reasons, we may have competition for both our biosimilar and vaccine products.
Moreover, because of the extensive time required for development, testing and regulatory review of a potential
product, it is possible that, before any of our products can be commercialized, any related patent may expire or

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remain in force for only a short period following commercialization, thereby reducing any advantage of the
patent.

We may rely, in some circumstances, on trade secrets to protect our technology. However, trade secrets are

difficult to protect. We seek to protect our technology and product candidates, in part, by entering into
confidentiality agreements with those who have access to our confidential information, including our employees,
consultants, advisors, contractors and collaborators. We also seek to preserve the integrity and confidentiality of
our proprietary technology and processes by maintaining physical security of our premises and physical and
electronic security of our information technology systems. While we have confidence in these individuals,
organizations and systems, agreements or security measures may be breached and we may not have adequate
remedies for any breach. In addition, our trade secrets may otherwise become known or be independently
discovered by competitors. To the extent that our employees, consultants, advisors, contractors and collaborators
use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or
resulting know-how and inventions. For this and more comprehensive risks related to our proprietary technology
and processes, please see “Risk Factors—Risks related to our intellectual property.”

Environmental Matters

Our research and development and manufacturing activities and our third-party manufacturers’ and
suppliers’ activities involve the controlled storage, use and disposal of hazardous materials owned by us,
including, small quantities of acetonitrile, methanol, ethanol, ethidium bromide and compressed gases, and other
hazardous compounds. We and our manufacturers and suppliers are subject to laws and regulations governing the
use, manufacture, storage, handling and disposal of these hazardous materials. In some cases, these hazardous
materials and various wastes resulting from their use are stored at our and our manufacturers’ facilities pending
their use and disposal. We seek to comply with applicable laws regarding the handling and disposal of such
materials. Given the small volume of such materials used or generated at our facilities, we do not expect our
compliance efforts to have a material effect on our capital expenditures, earnings, and competitive position.
However, we cannot eliminate the risk of accidental contamination or discharge and any resultant injury from
these materials. We do not currently maintain separate environmental liability coverage and any such
contamination or discharge could result in significant cost to us in penalties, damages, and suspension of our
operations.

Suppliers

We currently rely on, and expect to continue to rely on, contract manufacturers to produce sufficient
quantities of our product candidates for use in our clinical trials. In addition, we intend to rely on third parties to
manufacture any products that we may commercialize in the future. We have established an internal
pharmaceutical development group to develop manufacturing methods for our product candidates, to optimize
manufacturing processes, and to select and transfer these manufacturing technologies to our suppliers. We
contract with multiple manufacturers to ensure adequate product supply and to mitigate risk.

There currently are a limited number of these manufacturers. Furthermore, some of the contract
manufacturers that we have identified to date only have limited experience at manufacturing, formulating,
analyzing and packaging our product candidates in quantities sufficient for conducting clinical trials or for
commercialization.

Manufacturing

We do not own or operate facilities for cGMP manufacturing of any products. Although we intend to rely on

contract manufacturers, we have personnel with experience in the development of United States and European
Union cGMP-compliant processes and management of Contract Manufacturing Organizations (“CMOs”), to
oversee the technology transfer to the manufacturers of PF708, PF582, Px563L, Px533 and future product

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candidates that we may develop. Our manufacturing processes employ standard equipment common to CMOs.
Our processes also use common and widely available materials, and our well-established manufacturing
procedures are robust, scalable, and readily transferable to support our clinical development programs and
commercialization of our products. We believe that there are alternate sources of supply that can satisfy our
clinical and commercial requirements, although we cannot be certain that identifying and establishing
relationships with such sources, if necessary, would not result in significant delay or material additional costs.
For a discussion of risks related to our sources and availability of supplies, see “Risk Factors—Risks Relating to
our Reliance on Third Parties – We rely on third-party suppliers, and in some instances a single third-party
supplier, for the manufacture and supply of certain materials in our protein production services, and these
suppliers could cease to manufacture the materials, go out of business or otherwise not perform as anticipated.”

In each of our agreements with contract manufacturers, we retain ownership of our intellectual property and

generally own and/or are assigned ownership of processes, developments, data, results and other intellectual
property generated during the course of the performance of each agreement that primarily relate to our products.
Where applicable, we are granted non-exclusive licenses to certain contract manufacturer intellectual property for
purposes of exploiting the products that are the subject of the agreement, and in a few instances we grant non-
exclusive licenses to the contract manufacturers for use outside of our product area. In each contract, we have the
right to terminate for convenience. The agreements also contain typical provisions for both parties to terminate
for material breach, and bankruptcy and insolvency.

PF582. In December 2016, we entered into a contract manufacturing agreement for the cGMP

manufacturing of PF582.

Px563L. In July 2015, we entered into a contract manufacturing agreement for the cGMP fill and finish of

Px563L drug product for use in the Phase 1a clinical trial that was initiated in December 2015. All manufacturing
costs are funded by BARDA, pursuant to the contract awarded to us in August 2015.

Protein Production

Utilizing our Pfe¯nex Expression Technology®, we provide protein production and process development
services to third parties on a fee for service basis in support of the development of novel biopharmaceuticals.
Pursuant to a license agreement, the third-party licenses a production strain from us and then pays us an up-front
payment, milestone payments based upon clinical progression and regulatory filings, and a royalty based on
product net sales. Our protein production efforts enable us to maximize the utilization of our Pfe¯nex Expression
Technology®, expand our institutional knowledge and generate revenue.

Seasonality

Our revenues are not seasonal in nature.

U.S. Government Contracts

Revenue from U.S. Government contracts varies by year. A portion of our government business is subject to

renegotiation of profits or termination of contracts or subcontracts at the election of the U.S. Government. In
addition to contract terms, we must comply with procurement laws and regulations relating to the formation,
administration, and performance of U.S. Government contracts. Failure to comply with these laws and
regulations could lead to the termination of contracts at the election of the government or the suspension or
debarment from U.S. Government contracting or subcontracting. U.S. Government revenue as a percentage of
our total revenue was approximately 10%, 48% and 74% for fiscal years 2016, 2015 and 2014, respectively. For
further discussion of risks related to government contracting, see the discussion in Item 1A, “Risk Factors” in
this Form 10-K.

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Employees

We believe that our success will depend greatly on our ability to identify, attract and retain capable
employees. As of December 31, 2016, we had 63 employees, including a total of 16 employees who hold M.D.
and/or Ph.D. degrees. Our employees are not represented by any collective bargaining unit, and we believe our
relations with our employees are good.

Backlog

We have no material backlog of orders.

Research and Development

Over the last three fiscal years, we have invested over $54.7 million in principal research and development
programs ($32.4 million, $18.2 million and $4.1 million for the years ended December 31, 2016, 2015 and 2014,
respectively). Please see “Management’s Discussion and Analysis of Financial Condition and Results of
Operations” in this Annual Report on Form 10-K for additional information related to research and development
expenditures.

Geographic Information

During 2016, substantially all of our long-lived assets were located within the United States. With the
exception of $0.1 million of long-lived assets held by a third-party vendor in India for manufacturing purposes,
during 2015 all of our long-lived assets were located within the United States. During 2014, all of our long-lived
assets were located within the United States. Approximately 9% of our revenue for 2016, 12% of our 2015
revenue, and 18% of our 2014 revenue came from international markets. Please see Note 1 to our audited
financial statements included in Item 8 of this Annual Report on Form 10-K for additional information related to
our U.S. and non-U.S. revenue.

Corporate Information

We were founded in November 2009 as a Delaware corporation spun out of The Dow Chemical Company.
Our principal executive offices are located at 10790 Roselle St., San Diego, California 92121 and our telephone
number is (858) 352-4400. Our website is www.pfenex.com. We make available on our website, free of charge,
our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any
amendments to those reports, as soon as reasonably practicable after we electronically file such material with, or
furnish it to, the Securities and Exchange Commission, or SEC. Our SEC reports can be accessed through the
investor relations page of our website located at http://pfenex.investorroom.com. Additionally, a copy of this
Annual Report on Form 10-K is located at the SEC’s Public Reference Room at 100 F Street, NE, Washington,
D.C. 20549. Information on the operation of the Public Reference Room can be obtained by calling the SEC at
1-800-SEC-0330.

We webcast our earnings calls and certain events we participate in or host with members of the investment

community on our investor relations page of our website. Corporate governance information, including our board
committee charters, code of ethics and conduct, and corporate governance principles, is also available on our
investor relations page of our website located at http://pfenex.investorroom.com/corporate-governance. In
addition, we use our website (http://www.pfenex.com), our investor relations website
(http://pfenex.investorroom.com), press releases, SEC filings, public conference calls, corporate Twitter account
(https://twitter.com/pfenex), Facebook page
(https://www.facebook.com/Pfenex-Inc-105908276167776/timeline), and LinkedIn page
(https://www.linkedin.com/company/pfenex-inc) in order to achieve broad, non-exclusionary distribution of
information to the public. We encourage our investors and others to review the information we make public in
these locations as such information could be deemed to be material information. Please note that this list may be
updated from time to time.

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The contents of our website and the information we post through social media are not a part of, and are not

incorporated by reference into, this Annual Report on Form 10-K or any other report or document we file with
the SEC, and any references to our website and social media sites are intended to be inactive textual references
only.

Pfenex™, the Pfenex logo and other trademarks or service marks of Pfenex appearing in this Annual Report

on Form 10-K are the property of Pfenex Inc. Trade names, trademarks and service marks of other companies
appearing in this Annual Report on Form 10-K are the property of their respective holders.

Executive Officers

The following table identifies certain information about our executive officers as of March 2, 2017.

Name

Age

Position

Patrick K. Lucy . . . . . . . . . . . . . . . . .

Paul A. Wagner . . . . . . . . . . . . . . . . .
Patricia Lady . . . . . . . . . . . . . . . . . . .
Hubert C. Chen . . . . . . . . . . . . . . . . .
Henry W. Talbot . . . . . . . . . . . . . . . .
Steven S. Sandoval . . . . . . . . . . . . . .

49

Interim Chief Executive Officer, President, and Secretary, and
Chief Business Officer
Chief Financial Officer
46
Chief Accounting Officer
58
48
Chief Medical Officer
65 Vice President, Operations
51

Chief Manufacturing Officer

Patrick K. Lucy is currently serving as our Interim Chief Executive Officer, President, and Secretary, and

Chief Business Officer. He has served as our Chief Business Officer since 2014 and our Vice President of
Business Development and Marketing between 2009 and 2014. Prior to joining us, Mr. Lucy held the position of
Director of Business Development at DowPharma, a business within The Dow Chemical Company, a chemicals
manufacturer, from 2002 to 2009. From 1999 to 2002, he held the position of Director of Business Development
at Collaborative BioAlliance, Inc., a biotechnology company, which was acquired by The Dow Chemical
Company. From 1998 to 1999, Mr. Lucy worked as a Validation Manager and Capital Project Manager and from
1996 to 1998, as a Quality Control Biochemistry Supervisor at Lonza Biologics Inc., a chemicals and
biotechnology company. From 1991 to 1996, Mr. Lucy held various positions at Repligen Corporation, a life
sciences company. Mr. Lucy holds a Bachelor’s degree in Biology from Villanova University.

Paul A. Wagner has served as our Chief Financial Officer since 2014. From 2006 to 2014, Dr. Wagner held

the positions of Director and Portfolio Manager/Sr. Equity Analyst with Allianz Global Investors, a diversified
active investment manager where he was responsible for biotechnology and pharmaceutical investments. Prior to
that, Dr. Wagner was the Head of Development Licensing at PDL BioPharma, a diversified biopharmaceutical
company from 2005 until 2006. Prior to PDL BioPharma, Dr. Wagner held the position of Vice President at
Lehman Brothers, a global financial services firm, starting in 1999 until 2005. Dr. Wagner received a B.S. from
the University of Wisconsin and a Ph.D. in Chemistry from the California Institute of Technology. Dr. Wagner is
also a CFA charterholder.

Patricia Lady has served as our Chief Accounting Officer since 2011. Prior to serving in her current role,
Ms. Lady served as our Director of Finance and Corporate Controller from 2009 to 2011. From 2007 to 2009, she
served as Director of Finance and Accounting at Neurocrine Biosciences, Inc., a biopharmaceutical company.
From 2006 to 2007, Ms. Lady held the position of Corporate Controller of Avanir Pharmaceuticals, Inc., a
pharmaceutical company. From 2001 to 2005, Ms. Lady held the position of Vice President of Finance at 3E
Company, a technology company. From 2000 to 2001, she served as Vice President of Business Development of
Everypath, Inc., a technology company. From 1999 to 2000, Ms. Lady held the position of Vice President of
Business Development and Marketing at iOwn, Inc., a technology company. From 1997 to 1999, she served as
Vice President of Business Development at Careerbuilder, a technology company. Ms. Lady is a certified public

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accountant, a chartered global management accountant and a certified management accountant. Ms. Lady holds a
Bachelor’s degree in Accounting from California State University, Fullerton and an M.B.A. from the University
of California, Los Angeles.

Hubert C. Chen has served as our Chief Medical Officer since November 2014. From July 2012 to October

2014, Dr. Chen served as Vice President, Clinical Development of Aileron Therapeutics, a biopharmaceutical
company developing and advancing drugs using novel peptide-stabilizing technologies. From September 2009 to
June 2012, Dr. Chen served as Vice President, Translational Medicine of Regulus Therapeutics, a
biopharmaceutical company focused on the discovery and development of microRNA therapeutics. From
September 2006 to September 2009, Dr. Chen served as Director, Clinical Research and Senior Director, Clinical
Research and Corporate Development of Amylin Pharmaceuticals, a biopharmaceutical company engaged in the
discovery, development and commercialization of drug candidates for the treatment of diabetes, obesity and other
diseases. From March 2004 to September 2006, Dr. Chen served as Associate Director, Medical Sciences of
Amgen, Inc., a biopharmaceutical company discovering, developing, and manufacturing of innovative human
therapeutics. Additionally, from 2002 to 2012, Dr. Chen served as Assistant Clinical Professor of Medicine and
Clinical Instructor of Medicine at the University of California, San Francisco. From 2001 to 2004, Dr. Chen
served as a Staff Research Investigator, Staff Scientist, and Research Scientist at the Gladstone Institute of
Cardiovascular Disease. Dr. Chen received his medical residency training at Massachusetts General Hospital
from 1995 to 1998, his M.D. from Columbia University in 1995 and his B.A.S. in political science and biological
sciences from Stanford University in 1991.

Henry W. Talbot has served as our Vice President of Research and Operations since 2009. Prior to joining

us, Dr. Talbot held the position of Biotechnology Site Leader at The Dow Chemical Company, a chemicals
manufacturer, from 1999 to 2009. From 1994 to 1998, Dr. Talbot was Director of Fermentation and
Manufacturing at Mycogen Corporation, an agricultural sciences company, prior to it being acquired by The Dow
Chemical Company in 1998. Dr. Talbot holds a Bachelor’s degree in Biology from the University of Colorado,
Boulder, a Master of Science degree in Microbiology from the University of Missouri and a Ph.D. in
Microbiology from Oregon State University.

Steven S. Sandoval Sr. has served as our Chief Manufacturing Officer since September 2016. Prior to
joining us, Mr. Sandoval founded and served as the President and Chief Executive Officer of Pharmaceutical
Technical Solutions, Inc., a technical consulting firm, from 2010 to September 2016. From 2015 to 2016,
Mr. Sandoval held the position of Vice President, Engineering/Facilities of BioSciencesCorp LLC, a
pharmaceutical consulting company. Prior to that, Mr. Sandoval held various senior management positions with
Maple Leaf Foods Inc., a consumer foods firm, including Commissioning Director from 2010 to 2014 and
Engineering Director from 2014 to 2015. From 2008 to 2009, Mr. Sandoval served as Lead Senior Construction
Manager for Parsons, Inc., an engineering and construction firm. From 1989 to 2008, Mr. Sandoval held various
management positions at Amgen, Inc., a biopharmaceutical company, including Facilities and Engineering
Director from 2004 to 2008.

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Item 1A. Risk Factors

RISK FACTORS

Investing in our common stock involves a high degree of risk. You should carefully consider the risks and
uncertainties described below, together with all of the other information in this Annual Report on Form 10-K,
before making an investment decision. The risks and uncertainties described below may not be the only ones we
face. If any of the risks actually occur, our business, financial condition, operating results, cash flows and
prospects could be materially and adversely affected. In that event, the market price of our common stock could
decline, and you could lose part or all of your investment.

Risks Relating to our Financial Condition and Need for Additional Capital

We have a limited operating history and expect to generate significant losses for the foreseeable future. If we
do not generate significant revenue, we will not be profitable.

With the exception of two years, we have incurred annual net operating losses since inception, and to date
have generated only limited revenue from government contracts, service agreements, collaboration agreements,
and reagent protein product sales. We have recognized net income of $5.5 million for the year ending
December 31, 2016 and net losses of $28.2 million and $9.8 million for the years ending December 31, 2015 and
2014, respectively, and had an accumulated deficit of $136.0 million and net working capital of $69.7 million as
of December 31, 2016. To date, we have funded our operations primarily through the sale and issuance of
common stock in our public offerings, revenue from our collaboration agreements, government contracts, service
agreements, and reagent protein product sales, our prior credit facility and the private placement of equity
securities. As a result of the termination of the development and license agreement with Pfizer in August of 2016,
we will need to invest or find a collaboration partner to invest significant resources in the further development of
PF582. The termination accelerated recognition of $45.8 million of revenue that had been previously deferred.
As of December 31, 2016, we had capital resources consisting of cash and cash equivalents of $81.5 million.

As we continue to develop and invest more resources into the development and commercialization of our
product candidates, we expect that our expenses will increase substantially, and that our net operating losses will
increase over the next several years. To become profitable, we must successfully develop and obtain regulatory
approval for our product candidates, and effectively manufacture and commercialize the product candidates we
develop. If we obtain regulatory approval to market a product candidate, our future revenue will depend upon the
size of any markets in which our product candidates may receive approval, and our and our collaboration
partners’ ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payors, and
adequate market share for our product candidates in those markets. We may never succeed in these activities and
therefore may never generate revenue that is significant or large enough to achieve profitability. Even if we do
achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our
failure to become and remain profitable could depress the market price of our common stock and could impair
our ability to raise capital, expand our business, diversify our product offerings or continue our operations.

We will require substantial additional funds to seek and obtain regulatory approval for and commercialize our
two most advanced biosimilar and therapeutic equivalent product candidates and our other product candidates
and, if additional capital is not available, we may need to limit, scale back or cease our operations.

Since our inception, a significant portion of our resources have been dedicated to the preclinical and clinical

development of our two most advanced biosimilar and therapeutic equivalent product candidates, PF708 and
PF582. We believe that we will continue to expend substantial resources for the foreseeable future for the
preclinical and clinical development of our current product pipeline, and the development of any other
indications and product candidates we may choose to pursue, either alone or with our strategic collaboration
partners. These expenditures will include costs associated with research and development, conducting preclinical
studies and clinical trials, and manufacturing and supply as well as marketing and selling any products approved

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for sale. In addition, other unanticipated costs may arise. Because the outcome of any clinical trial is highly
uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development
and commercialization of PF708, PF582 and our pipeline of other product candidates and preclinical products
under development. As a result of the termination of the development and license agreement with Pfizer,
management is assessing all opportunities for the continued advancement of PF582, and we may be required to
devote additional resources to the development of PF582 or seek a new collaboration partner on short notice, and
the terms of any additional collaboration or other arrangements that we establish may not be favorable to us. We
may also need to obtain substantial additional sources of funding to develop PF582 as currently contemplated. If
such additional funding is not available on favorable terms or at all, we may need to delay or reduce the scope of
our PF582 development program, or grant rights in the United States, as well as outside the United States, to
PF582 to one or more partners.

We believe that our available cash and cash equivalents, including the proceeds from any revenue from our
government contracts, service agreements, collaboration agreements, and reagent protein product sales will allow
us to fund our operations for at least the next 12 months. In addition, we may seek additional capital due to
favorable market conditions or strategic considerations; even if we believe we have sufficient funds for our
current or future operating plans. Our future capital requirements may vary depending on the following:

•

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•

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•

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•

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•

•

•

•

the timing and extent of spending on our research and development efforts, including with respect to
PF708, PF582 and our other product candidates;

our ability to enter into and maintain collaboration, licensing, commercialization and other
arrangements and the terms and timing of such arrangements;

the cost of manufacturing and commercialization activities, if any;

the receipt of any collaboration or milestone payments;

the scope, rate of progress, results and cost of our clinical trials, preclinical testing and other related
activities;

the emergence of competing technologies or other adverse market developments;

the time and costs involved in seeking and obtaining regulatory and marketing approvals in multiple
jurisdictions for our product candidates that successfully complete clinical trials;

the cost of preparing, filing, prosecuting, defending and enforcing any patent claims and other
intellectual property rights;

the introduction of new product candidates and the number and characteristics of product candidates
that we pursue;

the timing, receipt and amount of sales, profit sharing or royalties, if any, from our potential products;

if approved, the degree and rate of market acceptance of any products launched by us or our
collaboration partners;

the expansion of our sales and marketing activities; and

the potential acquisition and in-licensing of other technologies, products or assets.

If we were to experience any delays or encounter issues with any of the above, including clinical holds,

failed studies, inconclusive or hard-to-interpret results, safety or efficacy issues, or other regulatory challenges
that require longer follow-up of existing studies, additional major studies, or additional supportive studies in
order to pursue marketing approval, it could further increase the costs associated with the above and delay
revenues.

We will need to raise additional capital to fund our operations in the near future. If we seek additional
funding in the future, additional funds may not be available to us on acceptable terms or at all. We may seek to

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raise additional funds through equity, equity-linked or debt financings. If we raise additional funds through the
incurrence of indebtedness, such indebtedness would have rights that are senior to holders of our equity securities
and could contain covenants that restrict our operations. Any additional equity financing may be dilutive to our
stockholders. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail the
advancement of one or more of our product candidates. We also could be required to seek funds through
arrangements with collaboration partners or others that may require us to relinquish rights to some of our
technologies or product candidates which we would otherwise pursue on our own.

The termination of our development and license agreement with Pfizer resulted in all rights to PF582 being
returned to us. Any further development of PF582 will require significant resources from us or another
collaboration partner, and in the event that we do not find a collaboration partner, the development of PF582
could be significantly delayed or result in the discontinuation of the development of PF582.

In August 2016, we and Pfizer entered into a termination agreement pursuant to which our development and

license agreement was terminated and all rights to PF582 were returned to us. The termination accelerated
recognition of $45.8 million of revenue that had been previously deferred and we will not recognize any
additional future revenue under the Pfizer license agreement.

Additionally, further development of PF582 will require significant resources from us or another

collaboration partner. We or a new collaboration partner will be responsible for funding any new PF582
development and clinical trial activities undertaken after the termination. Any such further development will
require significant resources to develop and commercialize PF582, and such further development may not be
possible in the near term without a new collaboration partner. There are no assurances that we will have access to
additional capital or find a new collaboration partner or that the terms and timing of any such arrangements
would be acceptable to us. As a result, we could experience a significant delay in the PF582 development
process. If we determine instead to discontinue the development of PF582, we will not receive any future return
on our investment from that product candidate.

Our quarterly operating results may fluctuate significantly.

Our operating results are subject to quarterly fluctuations. Our operating results are affected by numerous

factors, including:

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•

•

variations in the level of expenses related to our PF708 and PF582 development programs;

addition or termination of clinical trials;

any intellectual property infringement lawsuit in which we may become involved;

regulatory developments affecting any of our products; and

our execution of any service, collaborative, licensing or similar arrangements, and the timing of
payments we may make or receive under these arrangements.

If our quarterly operating results fall below the expectations of investors or securities analysts, the market
price of our common stock could decline substantially. Furthermore, any quarterly fluctuations in our operating
results may, in turn, cause the market price of our stock to fluctuate substantially.

Risks Relating to our Business and our Industry

If an improved version of a reference product, such as Lucentis or Forteo, is developed, or if the market for a
reference product significantly declines, sales or potential sales of our biosimilar and therapeutic equivalent
product candidates may suffer.

Reference product sponsor companies may develop improved versions of a reference product as part of a

life cycle extension strategy, and may obtain regulatory approval of the improved version under a supplemental

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biologics license application. If a reference product sponsor company succeeds in obtaining an approval of an
improved product, it may capture a significant share of the collective reference product market and significantly
reduce the market for the reference product, and thereby the potential size of the market for our biosimilar and
therapeutic equivalent product candidates. In addition, the improved product may be protected by additional
patent rights.

Additionally, competition in the pharmaceutical market is intense. Reference products face competition on

numerous fronts as technological advances are made that may offer patients a more convenient form of
administration or increased efficacy, or as new products are introduced. As new products are approved that
compete with the reference product to our biosimilar and therapeutic equivalent product candidates, such as
Lucentis or Forteo, sales of the reference products may be significantly and adversely impacted and may render
the reference product obsolete. If the market for the reference product is impacted, we in turn may lose
significant market share or market potential for our products and product candidates. As a result, the value of our
product pipeline could be negatively impacted and our business, prospects and financial condition could suffer.

Our product candidates, if approved, will face significant competition from the reference products and from
other biosimilars and therapeutic equivalent products of the reference products. Our failure to effectively
compete may prevent us from achieving significant market penetration and expansion.

We expect to enter highly competitive pharmaceutical markets. Successful competitors in the

pharmaceutical market have the ability to effectively discover, obtain patents, develop, test and obtain regulatory
approvals for products, as well as the ability to effectively commercialize, market and promote approved
products, including communicating the effectiveness, safety and value of products to consumers and medical
professionals. Numerous companies, universities, and other research institutions are engaged in developing,
patenting, manufacturing and marketing of products competitive with those that we are developing. Many of
these potential competitors, such as Novartis AG, Genentech, Inc., a wholly-owned member of the Roche Group,
Amgen Inc. and Eli Lilly and Company, are large, experienced companies that enjoy significant competitive
advantages, such as substantially greater financial, research and development, manufacturing, personnel and
marketing resources. Recent and potential future merger and acquisition activity in the biotechnology and
pharmaceutical industries are likely to result in even more resources being concentrated among a smaller number
of our competitors. These companies also maintain greater brand recognition and more experience and expertise
in undertaking preclinical testing and clinical trials of product candidates, and obtaining the U.S. Food and Drug
Administration, or FDA, and other regulatory approvals of products. Established pharmaceutical companies may
also invest heavily to accelerate discovery and development of novel compounds that could make our product
candidates obsolete.

In addition, our biosimilar and therapeutic equivalent products may face competition from companies that

develop and commercialize biosimilars and therapeutic equivalent products that compete directly with our
products. See “Risks Related to Government Regulation — If other biosimilars of Lucentis or other therapeutic
equivalent products to Forteo are approved and successfully commercialized before PF708 or PF582, our
business would suffer.”

Use of our product candidates could be associated with side effects or adverse events.

Use of our product candidates could be associated with side effects or adverse events which can vary in

severity (from minor reactions to death) and frequency (infrequent or prevalent). Side effects or adverse events
associated with the use of our product candidates may be observed at any time, including in clinical trials or
when a product is commercialized, and any such side effects or adverse events may negatively affect our and our
collaboration partners’ ability to obtain and maintain regulatory approval or market our product candidates. Side
effects such as toxicity or other safety issues associated with the use of our product candidates could require us or
our collaboration partners to perform additional studies or halt development or sale of these product candidates or
expose us to product liability lawsuits which will harm our business. We may be required by regulatory agencies

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to conduct additional animal or human studies regarding the safety and efficacy of our product candidates which
we have not planned or anticipated. We may also be required to change our product labeling, including
increasing the prominence and content of warnings and contraindications for our products. There can be no
assurance that we will resolve any issues related to any product-related adverse events to the satisfaction of the
FDA or any regulatory agency in a timely manner or ever, which could harm our business, prospects and
financial condition.

In addition, if we and our collaboration partners are successful in commercializing PF708 and PF582 or any other
product candidates the FDA, European Medicines Agency, or EMA, European Economic Area Competent Authorities,
or EEA Competent Authorities, and other foreign regulatory agency regulations require that we timely report certain
information about adverse medical events if those products may have caused or contributed to those adverse events.
The timing of our obligation to report would be triggered by the date we become aware of the adverse event as well as
the nature of the event. We or our collaboration partners may fail to report adverse events we become aware of within
the prescribed timeframe. We or our collaboration partners may also fail to appreciate that we or our collaboration
partners have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event or if
it is an adverse event that is unexpected or removed in time from the use of our products. If we or our collaboration
partners fail to comply with our reporting obligations, the FDA, the EMA, EEA Competent Authorities, or other
foreign regulatory agencies could take action including criminal prosecution, the imposition of civil monetary
penalties, seizure of our products, or delay in approval or clearance of future products.

If we fail to attract and keep senior management and key scientific personnel, we may be unable to
successfully develop PF708, PF582 or any future product candidates, conduct our clinical trials and
commercialize PF708, PF582 or any future product candidates we develop.

Our success depends in part on our continued ability to attract, retain and motivate highly qualified
management, clinical and scientific personnel. We believe that our future success is highly dependent upon the
contributions of our senior management, particularly our Interim Chief Executive Officer and Chief Business
Officer, Chief Financial Officer, and Chief Medical Officer, as well as our senior scientists and other members of
our senior management team. Employment agreements with each of our Chief Executive Officer and Chief
Business Officer, Chief Financial Officer, Chief Medical Officer, and other senior executives, as well as our offer
letters with our senior scientists, all provide for “at-will” employment. The loss of services of any of these
individuals could delay or prevent the successful development of our product pipeline, completion of our planned
clinical trials or the commercialization of PF708, PF582 or any future products we develop.

We are currently undertaking a search for a permanent chief executive officer. The transition to a permanent

chief executive officer may be disruptive to our business and, during the transition period, there may be
uncertainty among investors and others concerning our future direction and performance. It also may be more
difficult for us to recruit and retain other personnel until a permanent chief executive officer is identified. The
failure to successfully hire a chief executive officer or other executives and key employees, or the loss of any
additional executives and key employees, could have a significant impact on our operations.

Although we have not historically experienced significant difficulties attracting and retaining qualified
employees, we could experience such problems in the future. For example, competition for qualified personnel in
the biotechnology and pharmaceuticals industry is intense due to the limited number of individuals who possess
the skills and experience required. We will need to hire additional personnel as we expand our clinical
development and commercial activities. We may not be able to attract and retain quality personnel on acceptable
terms, or at all, which may cause our business and operating results to suffer.

We currently rely on a limited number of collaboration partners for a substantial portion of our revenue. The
loss of or a change in any significant collaboration partner, including its credit worthiness, could materially
reduce our revenue and adversely impact our financial position.

One collaboration partner accounted for more than 10% of our 2016 revenue, two collaboration partners
accounted for more than 10% of our 2015 revenue, and three collaboration partners accounted for more than 10%

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of our revenue in 2014. Pfizer accounted for more than 10% of our 2016 revenue, and Pfizer and the Biomedical
Advanced Research and Development Authority, or BARDA, each accounted for more than 10% of our revenue
in 2015. BARDA, the National Institute of Allergy and Infectious Diseases, or NIAID, and Boehringer Ingelheim
International GmbH each accounted for more than 10% of our revenue in 2014.

In August 2016, we entered into a termination agreement with Pfizer pursuant to which our development

and license agreement was terminated and all rights to PF582 returned to us. The termination accelerated
recognition of $45.8 million of revenue that had been previously deferred and we will not recognize any
additional future revenue under this agreement. Pfizer will no longer be responsible for manufacturing, clinical
studies and commercialization of PF582. We will not receive additional revenue from Pfizer.

The loss of any key collaboration partner or any significant adverse change in the size or terms of a contract
with a key collaboration partner, such as the termination of the development and license agreement with Pfizer in
August 2016, could significantly reduce our revenue over the short term. Moreover, having our revenue
concentrated among a limited number of entities creates a concentration of financial risk for us, and in the event
that any significant collaboration partner is unable to fulfill its payment obligations to us, our operating results
and cash position would suffer. See “Risks Relating to our Reliance on Third Parties — We are substantially
dependent on the expertise of Strides Arcolab and Jazz to develop and commercialize some of our product
candidates. If we fail to maintain our current strategic relationship with Strides Arcolab and Jazz, our business,
commercialization prospects and financial condition may be materially adversely affected.”

We currently have limited marketing capabilities and no sales organization.

We currently have limited sales and marketing capabilities. We have no prior experience in the marketing,

sale and distribution of pharmaceutical products and there are significant risks involved in building and
managing a sales organization, including our ability to hire, retain and incentivize qualified individuals, generate
sufficient sales leads, provide adequate training to sales and marketing personnel and effectively manage a
geographically dispersed sales and marketing team.

We will need to invest or find a collaboration partner to invest significant resources in the further

development of PF582. In the event that we independently advance PF582 as a wholly-owned product candidate,
we will need to identify potential sales, marketing and distribution partners or establish our own internal sales
force. For PF708, we will need to identify potential sales, marketing and distribution partners or establish our
own internal sales force. In the future, we may choose to collaborate with other third parties that have direct sales
forces and established distribution systems, either to augment our own sales force or in lieu of our own sales
force. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to
successfully commercialize our product candidates. If we are not successful in commercializing our product
candidates, either on our own or through collaborations with one or more third parties, our future product revenue
will suffer and we would incur significant additional losses.

We enter into various contracts in the normal course of our business that periodically incorporate provisions
whereby we indemnify the other party to the contract. In the event we would have to perform under these
indemnification provisions, it could have a material adverse effect on our business, financial position and
results of operations.

In the normal course of business, we periodically enter into academic, commercial and consulting
agreements that contain indemnification provisions. With respect to our academic agreements, we may be
required to indemnify the institution and related parties from losses arising from claims relating to the products,
processes or services made, used, sold or performed pursuant to the agreements for which we have secured
licenses, and from claims arising from our or our sublicensees’ exercise of rights under the agreement. With
respect to commercial agreements entered into with our protein production customers, we typically provide
indemnification for claims from third parties arising out of any potential intellectual property infringement

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associated with our Pfe¯nex Expression Technology® in the course of performing our services. With respect to our
commercial agreements, the bulk of which are with contract manufacturers, we indemnify our vendors from
third-party product liability claims which result from the production, use or consumption of the product, as well
as for certain alleged infringements of any patent or other intellectual property right by a third party. With respect
to consultants, we indemnify them from claims arising from the good faith performance of their services. In all of
the above cases, we do not indemnify the parties for claims resulting from the negligence or willful misconduct
of the indemnified party.

In certain circumstances, we maintain insurance coverage which we believe may limit our obligations under

certain of these indemnification provisions. However, we do not carry insurance for all risks that our business
may encounter, including our obligations under certain indemnification provisions. To the extent we do not have
insurance to cover certain indemnification obligations, we are denied insurance coverage, or our obligation under
an indemnification provision exceeds applicable insurance coverage, any significant, uninsured liability may
require us to pay substantial amounts, which would adversely affect our working capital and results of
operations.

We may have difficulty managing our growth and expanding our operations successfully.

As we advance our product candidates through the development process, we will need to expand our

development, regulatory, manufacturing, quality, sales and marketing capabilities or contract with other
organizations to provide these capabilities for us. As our operations expand, we expect that we will need to
manage additional relationships with various collaborative partners, suppliers and other organizations.

As of December 31, 2016, we had 63 full-time employees. Our management and personnel, systems and

facilities currently in place may not be adequate to support this future growth. Therefore, we will need to
continue to expand our managerial, operational, finance and other resources to manage our operations and
clinical trials, continue our development activities and commercialize our product candidates, if approved. In
order to effectively execute our growth strategy, we will be required to:

• manage our clinical trials effectively;

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identify, recruit, retain, incentivize and integrate additional employees;

establish and maintain collaborations with third parties for the development and commercialization of
our product candidates, or otherwise build and maintain a sales, marketing and distribution
infrastructure to commercialize any products for which we may obtain marketing approval;

• manage our internal development efforts effectively while carrying out our contractual obligations to

third parties; and

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continue to improve our operational, financial and management controls, reporting systems and
procedures.

Due to our limited financial resources and our limited experience in managing a company with such

anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train
additional qualified personnel. In addition, this expansion of our operations may lead to significant costs and may
divert our management and business development resources. Any inability to manage growth could delay the
execution of our development and strategic objectives, or disrupt our operations, which could materially impact
our business, revenue, and operating results.

The U.S. government holds certain intellectual property rights related to our Anthrax vaccine, Px563L and
Malaria vaccine, Px533.

Although we have intellectual property related to expression of recombinant protective antigen in P.
fluorescens, the U.S. government holds certain patents related to the recombinant protective antigen, as well as
certain license rights to intellectual property related to other Px563L components used to produce the final

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vaccine, which, if exercised, could materially impact our business, revenue and operating results. We have rights
to utilize this intellectual property held by the U.S. government by virtue of the Authorization and Consent
clauses of our contracts with the U.S. government.

Our contracts with the U.S. government, and our subcontracts with U.S. government contractors, require
ongoing funding decisions by the U.S. government; reduced or discontinued funding of these contracts could
cause our financial condition and operating results to suffer materially.

Development of our anthrax vaccine, Px563L, is funded by BARDA and development of our Px563L-SDI
anthrax vaccine and our malaria vaccine, Px533, is funded by NIAID. The funding for government programs is
subject to Congressional appropriations, often made on a fiscal year basis, even for programs designed to
continue for several years. These appropriations can be subject to political considerations and stringent budgetary
constraints. Additionally, our government-funded development contracts give the U.S. government the right,
exercisable in its sole discretion, to extend this contract for successive option periods following a base period of
performance. The value of the services to be performed during these option periods may constitute the majority
of the total value of the underlying contract. If levels of government expenditures and authorizations for
biodefense decrease or shift to programs in areas where we do not offer products or are not developing product
candidates, or if the U.S. government otherwise declines to exercise its options under its contracts with us, our
business, revenue and operating results would suffer.

Our current contracts with BARDA and NIAID are cost plus fixed fee contracts and potential future
contracts with the U.S. government may also be structured this way. Under our cost plus fixed fee contracts, we
are allowed to recover our approved costs plus a fixed fee. The total price on a cost plus fixed fee contract is
based primarily on allowable costs incurred, but generally is subject to contract funding limitations. U.S.
government regulations require us to notify our customer of any cost overruns or underruns on a cost plus
contract. If we incur costs in excess of the funding limitation specified in the contract, we may not be able to
recover those cost overruns.

Moreover, changes in U.S. government contracting policies could directly affect our financial performance.

Factors that could materially adversely affect our U.S. government contracting business include:

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budgetary constraints affecting U.S. government spending generally, or specific departments or
agencies in particular;

changes in U.S. government fiscal policies or available funding;

changes in U.S. government defense and homeland security priorities;

changes in U.S. government programs or requirements;

adoption of new laws or regulations;

technological developments;

• U.S. government shutdowns, threatened shutdowns or budget delays;

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competition and consolidation in our industry; and

general economic conditions.

These or other factors could cause U.S. government departments or agencies to reduce their development

funding or future purchases under contracts, to exercise their right to terminate contracts or fail to exercise their
options to extend our contracts, any of which could have a material adverse effect on our business, financial
condition, operating results and ability to meet our financial obligations.

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Unfavorable provisions in government contracts, some of which are customary, may subject our business to
material limitations, restrictions and uncertainties and may have a material adverse impact on our financial
condition and operating results.

Government contracts contain provisions that give the U.S. government substantial rights and remedies,

many of which are not typically found in commercial contracts, including provisions that allow the U.S.
government to:

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terminate existing contracts, in whole or in part, for any reason or no reason;

unilaterally reduce or modify the government’s obligations under such contracts or subcontracts,
without the contractor’s consent, including by imposing equitable price adjustments;

audit contract-related costs and fees, including allocated indirect costs;

claim rights, including intellectual property rights, in products and data developed under such
agreements;

under certain circumstances involving public health and safety, license inventions made under such
agreements to third parties;

suspend the contractor from receiving new contracts pending resolution of alleged violations of
procurement laws or regulations;

impose U.S. manufacturing requirements for products that embody inventions conceived or first
reduced to practice under such contracts;

suspend or debar the contractor from doing future business with the government;

decline to exercise an option to continue a contract;

exercise an option to purchase only the minimum amount, if any, specified in a contract;

decline to exercise an option to purchase the maximum amount, if any, specified in a contract;

claim rights to facilities or to products, including intellectual property, developed under the contract;

require repayment of contract funds spent on construction of facilities in the event of contract default;

take actions that result in a longer development timeline than expected;

change the course of a development program in a manner that differs from the contract’s original terms
or from our desired development plan, including decisions regarding our partners in the program;

pursue civil or criminal remedies under the False Claims Act, or FCA, and False Statements Act; and

control or prohibit the export of products.

Generally, government contracts, including our contracts with BARDA and NIAID, contain provisions
permitting unilateral termination or modification, in whole or in part, at the U.S. government’s convenience.
Under general principles of government contracting law, if the U.S. government terminates a contract for
convenience, the government contractor may recover only its incurred or committed costs, settlement expenses
and profit on work completed prior to the termination. If the U.S. government terminates a contract for default,
the government contractor is entitled to recover costs incurred and associated profits on accepted items only and
may be liable for excess costs incurred by the government in procuring undelivered items from another source. In
addition, government contracts normally contain additional requirements that may increase our costs of doing
business, reduce our profits, and expose us to liability for failure to comply with these terms and conditions.
These requirements include, for example:

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specialized accounting systems unique to government contracts;

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• mandatory financial audits and potential liability for price adjustments or recoupment of government

funds after such funds have been spent;

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public disclosures of certain contract information, which may enable competitors to gain insights into
our research program;

• mandatory internal control systems and policies; and

• mandatory socioeconomic compliance requirements, including labor standards, non-discrimination and

affirmative action programs and environmental compliance requirements.

If we fail to maintain compliance with these requirements, we may be subject to potential contract or FCA

liability and to termination of our contracts.

Furthermore, we are required to enter into agreements and subcontracts with third parties, including
suppliers, consultants and other third-party contractors in order to satisfy our contractual obligations pursuant to
our agreements with the United States government. Negotiating and entering into such arrangements can be time-
consuming and we may not be able to reach agreement with such third parties. Any such agreement must also be
compliant with the terms of our government contract. Any delay or inability to enter into such arrangements or
entering into such arrangements in a manner that is non-compliant with the terms of our contract, may result in
violations of our contract.

We may not have the right to prohibit the U.S. government from using certain technologies developed by us,
and we may not be able to prohibit third-party companies, including our competitors, from using those
technologies in providing products and services to the U.S. government. The U.S. government generally takes
the position that it has the right to royalty-free use of technologies that are developed under U.S. government
contracts.

Most U.S. government contracts grant the U.S. government the right to use on a royalty free basis, for or on

behalf of the U.S. government, any technologies developed and data first produced by the contractor under the
government contract. If we were to develop technology under a contract with such a provision, we might not be
able to prohibit third parties, including our competitors, from using that technology in providing products and
services to the U.S. government.

Our business is subject to audit by the U.S. government and a negative audit could adversely affect our
business.

U.S. government agencies such as the Department of Health and Human Services, or HHS, and the Defense

Contract Audit Agency, or the DCAA, routinely audit and investigate government contractors and recipients of
federal grants and contracts. These agencies review a contractor’s performance under its contracts, cost structure
and compliance with applicable laws, regulations and standards.

The HHS and the DCAA also review the adequacy of, and a contractor’s compliance with, its internal

control systems and policies, including the contractor’s accounting, purchasing, property, estimating,
compensation and management information systems. Any costs found to be improperly allocated to a specific
contract will not be reimbursed, while such costs already reimbursed must be refunded. If an audit uncovers
improper or illegal activities, we may be subject to civil and criminal penalties and administrative sanctions,
including:

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termination of contracts;

forfeiture of profits;

suspension of payments;

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fines; and

suspension or prohibition from conducting business with the U.S. government.

In addition, we could suffer serious reputational harm if allegations of impropriety were made against us,

which could cause our stock price to decrease.

The United States government’s determination to award a future contract may be challenged by an interested
party, such as another bidder, at the United States Government Accountability Office, or the GAO, or in
federal court. If such a challenge is successful, any future contract we may be awarded may be terminated.

The laws and regulations governing the procurement of goods and services by the U.S. government provide

procedures by which other bidders and interested parties may challenge the award of a government contract. If
we are awarded a government contract, such challenges or protests could be filed even if there are not any valid
legal grounds on which to base the protest. If any such protests are filed, the government agency may decide to
suspend our performance under the contract while such protests are being considered by the GAO or the
applicable federal court, thus potentially delaying delivery of payment. In addition, we could be forced to expend
considerable funds to defend any potential award. If a protest is successful, the government may be ordered to
terminate the contract and resolicit proposals. The government agencies with which we have contracts could even
be directed to award a potential contract to one of the other bidders.

Laws and regulations affecting government contracts make it more costly and difficult for us to successfully
conduct our business.

We must comply with numerous laws and regulations relating to the formation, administration and
performance of government contracts, which can make it more difficult for us to retain our rights under our
government contracts, including our contracts with BARDA and NIAID. These laws and regulations affect how
we conduct business with government agencies. Among the most significant government contracting regulations
that affect our business are:

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the Federal Acquisition Regulations, or FAR, and agency-specific regulations supplemental to the
FAR, which comprehensively regulate the procurement, formation, administration and performance of
government contracts;

the Truth in Negotiations Act, which requires certification and disclosure of cost or pricing data in
connection with contract negotiations;

business ethics and public integrity obligations, which govern conflicts of interest and the hiring of
former government employees, restrict the granting of gratuities and funding of lobbying activities and
include other requirements such as the Anti-Kickback Statute and Foreign Corrupt Practices Act;

export and import control laws and regulations; and

laws, regulations and executive orders restricting the use and dissemination of information classified
for national security purposes and the exportation of certain products and technical data.

Any material changes in applicable laws and regulations could restrict our ability to maintain our existing
BARDA and NIAID contracts and obtain new contracts, which could limit our ability to conduct our business
and materially adversely affect our results of operations.

Agreements with government agencies may lead to claims against us under the Federal False Claims Act, and
these claims could result in substantial fines and other penalties.

The biopharmaceutical industry is, and in recent years has been, under heightened scrutiny as the subject of
government investigations and enforcement actions. Our government contracts are subject to substantial financial

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penalties under the Federal Civil Monetary Penalties Act and the FCA. Under the FCA’s “whistleblower”
provisions, private enforcement of fraud claims against businesses on behalf of the U.S. government has
increased due in part to amendments to the FCA that encourage private individuals to sue on behalf of the
government. These whistleblower suits, known as qui tam actions, may be filed by private individuals, including
present and former employees. The FCA statute provides for treble damages and up to $11,000 per false claim. If
our operations are found to be in violation of any of these laws, or any other governmental regulations that apply
to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from the
Medicare and Medicaid programs, and the curtailment or restructuring of our operations. Any penalties,
damages, fines, exclusions, curtailment, or restructuring of our operations could adversely affect our ability to
operate our business and our financial results.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to
limit commercialization of any future products we develop.

We face a risk of product liability as a result of the clinical testing of our product candidates and will face an

even greater risk if we commercialize any products. For example, we may incur liability if any product we
develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing,
marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects
in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of
warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend
ourselves against product liability claims, we may incur substantial liabilities or be required to limit
commercialization of our products. Regardless of the merits or eventual outcome, liability claims may result in:

•

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decreased demand for PF708, PF582 or any future product candidates or products we develop;

injury to our reputation and significant negative media attention;

• withdrawal of clinical trial participants or cancellation of clinical trials;

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costs to defend the related litigation;

a diversion of management’s time and our resources;

substantial monetary awards to trial participants or patients;

regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional
restrictions;

loss of revenue; and

the inability to commercialize any products we develop.

Our inability to obtain and maintain sufficient product liability insurance at an acceptable cost and scope of

coverage to protect against potential product liability claims could impact the commercialization of PF708,
PF582 and any future products we develop. We currently carry product liability insurance covering our clinical
trials in the amount of $10.0 million in the aggregate. Although we maintain such insurance, any claim that may
be brought against us could result in a court judgment or settlement that is in excess of the limits of our insurance
coverage. Our insurance policies also have various exclusions and deductibles, and we may be subject to a
product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or
negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we
may not have, or be able to obtain, sufficient capital to pay such amounts. Moreover, in the future, we may not be
able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. If
and when we obtain approval for marketing PF708, PF582 or any other product candidates, we intend to expand
our insurance coverage to include the sale of such products; however, we may be unable to obtain this liability
insurance on commercially reasonable terms.

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Our employees, independent contractors, principal investigators, CROs, consultants and collaboration
partners may engage in misconduct or other improper activities, including noncompliance with regulatory
standards and requirements and insider trading.

We are exposed to the risk that our employees, independent contractors, principal investigators, third-party

clinical research organizations, or CROs, consultants and collaboration partners may engage in fraudulent
conduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent
conduct or unauthorized activities that violate: (1) regulations of the FDA and comparable foreign authorities,
including those laws requiring the reporting of true, complete and accurate information to such authorities;
(2) manufacturing standards; (3) federal and state healthcare fraud and abuse laws and regulations; or (4) laws
that require the reporting of true and accurate financial information and data. In particular, sales, marketing and
business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent
fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or
prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive
programs and other business arrangements. These activities also include the improper use of information
obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our
reputation. We have adopted a Code of Ethics and Conduct, but it is not always possible to identify and deter
misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity
may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental
investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or
regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or
asserting our rights, those actions could have a significant impact on our business including the imposition of
significant civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from
participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational
harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely
affect our ability to operate our business and our results of operations.

Our cash and cash equivalents and short term investments could be adversely affected if the financial
institutions in which we hold our cash and cash equivalents and short term investments fail.

We regularly maintain cash balances at third-party financial institutions in excess of the Federal Deposit
Insurance Corporation, or FDIC, insurance limit. While we monitor the cash balances in our accounts and adjust
the balances as appropriate, these balances could be impacted, and there could be a material adverse effect on our
business, if one or more of the financial institutions with which we deposit fails or is subject to other adverse
conditions in the financial or credit markets. To date, we have experienced no loss or lack of access to our
invested cash or cash equivalents; however, we can provide no assurance that access to our invested cash and
cash equivalents will not be impacted by adverse conditions in the financial and credit markets.

We may be subject to information technology failures, including data protection breaches and cyber-attacks,
that could disrupt our operations, damage our reputation and adversely affect our business, operations, and
financial results.

We rely on our information technology systems for the effective operation of our business and for the secure

maintenance and storage of confidential data relating to our business and third party businesses. Although we
have implemented security controls to protect our information technology systems, experienced programmers or
hackers may be able to penetrate our security controls, and develop and deploy viruses, worms and other
malicious software programs that compromise our confidential information or that of third parties and cause a
disruption or failure of our information technology systems. Any such compromise of our information
technology systems could result in the unauthorized publication of our confidential business or proprietary
information, result in the unauthorized release of customer, supplier or employee data, result in a violation of
privacy or other laws, expose us to a risk of litigation, or damage our reputation. The cost and operational
consequences of implementing further data protection measures either as a response to specific breaches or as a

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result of evolving risks, could be significant. In addition, our inability to use or access our information systems at
critical points in time could adversely affect the timely and efficient operation of our business. Any delayed
sales, significant costs or lost customers resulting from these technology failures could adversely affect our
business, operations and financial results.

Third parties with which we conduct business have access to certain portions of our sensitive data. In the
event that these third parties do not properly safeguard our data that they hold, security breaches could result and
negatively impact our business, operations and financial results.

Our business involves the use of hazardous materials and we, our collaboration partners, and our third-party
manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive
and restrict how we do business.

Our research and development and manufacturing activities and our third-party manufacturers’ and
suppliers’ activities involve the controlled storage, use and disposal of hazardous materials owned by us,
including small quantities of acetonitrile, methanol, ethanol, ethidium bromide and compressed gases, and other
hazardous compounds. We and our collaboration partners, manufacturers and suppliers are subject to laws and
regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In some
cases, these hazardous materials and various wastes resulting from their use are stored at our and our
manufacturers’ facilities pending their use and disposal. We cannot eliminate the risk of contamination, which
could cause an interruption of our commercialization efforts, research and development efforts and business
operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and
regulations governing the use, storage, handling and disposal of these materials and specified waste products.

Although we believe that the safety procedures utilized by us and our third-party manufacturers for handling

and disposing of these materials generally comply with the standards prescribed by these laws and regulations,
we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these
materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our
resources and state or federal or other applicable authorities may curtail our use of certain materials and interrupt
our business operations.

We are also subject to numerous environmental, health and workplace safety laws and regulations, including

those governing laboratory procedures, and the handling of biohazardous materials. Although we maintain
workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our
employees resulting from the use of these materials, this insurance may not provide adequate coverage against
potential liabilities. For claims not covered by workers’ compensation insurance, we also maintain an employer’s
liability insurance policy in the amount of $1.0 million per occurrence and in the aggregate. We do not maintain
insurance for environmental liability or toxic tort claims that may be asserted against us.

Environmental laws and regulations are complex, change frequently and have tended to become more

stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. Any
inability to comply with environmental laws and regulations may adversely affect our business and operating
results.

Changes in accounting principles, or interpretations thereof, could have a significant impact on our financial
position and results of operations.

We prepare our consolidated financial statements in accordance with accounting principles generally
accepted in the United States of America, referred to as GAAP. These principles are subject to interpretation by
the SEC and various bodies formed to interpret and create appropriate accounting principles. A change in these
principles can have a significant effect on our reported results and may even retroactively affect previously
reported transactions. Additionally, the adoption of new or revised accounting principles may require that we
make significant changes to our systems, processes and controls.

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It is not clear if or when these potential changes in accounting principles may become effective, whether we

have the proper systems and controls in place to accommodate such changes and the impact that any such
changes may have on our financial position and results of operations.

Risks Relating to our Reliance on Third Parties

We are substantially dependent on the expertise of Strides Arcolab and Jazz to develop and commercialize
some of our product candidates. If we fail to maintain our current strategic relationship with Strides Arcolab
and Jazz, our business, commercialization prospects and financial condition may be materially adversely
affected.

Because we have limited or no capabilities for late-stage product development, manufacturing, sales,
marketing and distribution, we may need to enter into alliances with other companies to develop our product
candidates. For example, we have entered into agreements with Strides Arcolab and Jazz, pursuant to which we
will transfer the development, manufacture and commercialization of some of our products.

In February 2015, we entered into a development and license agreement with Pfizer to develop and
commercialize PF582. In August 2016, we entered into a termination agreement with Pfizer pursuant to which
the development and license agreement was terminated and all rights to PF582 have been returned to us. The
termination accelerated recognition of $45.8 million of revenue that had been previously deferred and we will not
recognize any additional future revenue under the Pfizer development and license agreement. We may seek a
new collaboration partner for the development and commercialization of PF582, however there are no assurances
that we can find a new collaboration partner or that the terms and timing of any such arrangements would be
acceptable to us. As a result, we could experience a significant delay in the PF582 development process.

For the products included in the Joint Development & License Agreement, or JDLA, Strides Arcolab is
responsible for development expenses up to Phase 3, at which time we will share in expenses and revenue going
forward. Additionally, we will transfer the development, manufacture and commercialization of the products to a
joint venture company jointly owned by us and Strides Arcolab upon completion of Phase 1 trials.

In July 2016, we entered into a license and option agreement with Jazz, pursuant to which we and Jazz will
collaboratively develop certain hematology products, and Jazz will have the exclusive right to manufacture and
commercialize such products throughout the world. In addition, pursuant to the agreement, we have granted Jazz
certain other rights to negotiate the exclusive right to develop, manufacture and commercialize throughout the
world other hematology products that are currently or in the future may be developed by us, including PF690
(pegaspargase), a biosimilar candidate to the reference product Oncaspar. In consideration for the exclusive
licenses and other rights contained in the agreement, we received upfront and option payments totaling $15
million in July 2016, and may be eligible to receive additional payments of up to $166 million based on the
achievement of certain development, regulatory, and sales-related milestones, including up to $41 million for
certain non-sales-related milestones. We may also be eligible to receive tiered royalties on worldwide sales of
any products resulting from the collaboration.

The prospects for the product candidates developed under these collaborations depend on the expertise,

development and commercial skills, and financial strength of Strides Arcolab and Jazz, respectively. Our
collaborations with Strides Arcolab, Jazz or any future collaboration partner may not be successful, and we may
not realize the expected benefits from such collaborations, due to a number of important factors, including but
not limited to the following:

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•

Strides Arcolab, Jazz or any future collaboration partner may terminate their agreements with us prior
to completing development or commercialization of our product candidates, in whole or in part,
adversely impacting our potential approval and revenue from licensed products;

the timing and amount of any payments we may receive under these agreements will depend on, among
other things, the efforts, allocation of resources, and successful commercialization of the relevant

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product candidates by Strides Arcolab, Jazz or any future collaboration partner, as applicable, under
our agreements;

the timing and amounts of expense reimbursement that we may receive are uncertain; or

Strides Arcolab, Jazz or any future collaboration partner may change the focus of their development or
commercialization efforts or pursue or emphasize higher priority programs.

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A failure of Strides Arcolab, Jazz or any future collaboration partner to successfully develop our product
candidates which are covered by the collaboration, or commercialize such product candidates, or the termination
of our agreement with Strides Arcolab, Jazz or any future collaboration partner, as applicable, may have a
material adverse effect on our business, results of operations and financial condition.

Our existing product development and/or commercialization arrangements, and any that we may enter into in
the future, may not be successful, which could adversely affect our ability to develop and commercialize our
product candidates.

We are a party to, and continue to seek additional, collaboration arrangements with other pharmaceutical
companies for the development and/or commercialization of our current and future product candidates. In such
alliances, we would expect our collaboration partners to provide substantial capabilities in clinical development,
manufacturing, regulatory affairs, sales and marketing, both in the United States and internationally.

To the extent that we decide to enter into collaboration agreements, we will face significant competition in

seeking appropriate collaboration partners. Any failure to meet our clinical milestones with respect to an
unpartnered product candidate would make finding a collaboration partner more difficult. Moreover,
collaboration arrangements are complex and time consuming to negotiate, document and implement, and we
cannot guarantee that we can successfully maintain such relationships or that the terms of such arrangements will
be favorable to us. If we fail to establish and implement collaboration or other alternative arrangements, the value
of our business and operating results will be adversely affected.

We may not be successful in our efforts to establish, implement and maintain collaborations or other
alternative arrangements if we choose to enter into such arrangements. The terms of any collaboration or other
arrangements that we may establish may not be favorable to us. The management of collaborations may take
significant time and resources that distract our management from other matters. Our ability to successfully
collaborate with any future collaboration partners may be impaired by multiple factors including:

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a collaboration partner may shift its priorities and resources away from our programs due to a change
in business strategies, or a merger, acquisition, sale or downsizing of its company or business unit;

a collaboration partner may cease development in therapeutic areas which are the subject of alliances
with us;

a collaboration partner may change the success criteria for a particular program or product candidate
thereby delaying or ceasing development of such program or candidate;

a significant delay in initiation of certain development activities by a collaboration partner will also
delay payments tied to such activities, thereby impacting our ability to fund our own activities;

a collaboration partner could develop a product that competes, either directly or indirectly, with our
current or future products, if any;

a collaboration partner with commercialization obligations may not commit sufficient financial or
human resources to the marketing, distribution or sale of a product;

a collaboration partner with manufacturing responsibilities may encounter regulatory, resource or
quality issues and be unable to meet demand requirements;

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•

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a collaboration partner may exercise its rights under the agreement to terminate our collaboration;

a dispute may arise between us and a collaboration partner concerning the research or development of a
product candidate or commercialization of a product resulting in a delay in milestones, royalty
payments or termination of a program and possibly resulting in costly litigation or arbitration which
may divert management attention and resources;

the results of our clinical trials may not match our collaboration partners’ expectations, even if
statistically significant;

a collaboration partner may not adequately protect or enforce the intellectual property rights associated
with a product or product candidate; and

a collaboration partner may use our proprietary information or intellectual property in such a way as to
invite litigation from a third party.

Any such activities by our current or future collaboration partners could adversely affect us financially and

could harm our business reputation.

In addition to product development and commercialization capabilities, we may depend on our alliances
with other companies to provide substantial additional funding for development and potential commercialization
of our product candidates. We may not be able to obtain funding on favorable terms from these alliances, and if
we are not successful in doing so, we may not have sufficient funds to develop a particular product candidate
internally, or to bring product candidates to market. Failure to bring our product candidates to market will
prevent us from generating sales revenue, and this may substantially harm our business. Furthermore, any delay
in entering into these alliances could delay the development and commercialization of our product candidates and
reduce their competitiveness even if they reach the market. As a result, our business and operating results may be
adversely affected.

We rely on CROs to conduct and oversee our planned clinical trials for our product candidates and other
clinical trials for product candidates we are developing or may develop in the future. If our CROs do not
successfully carry out their contractual duties, meet expected deadlines, or otherwise conduct the trials as
required or comply with regulatory requirements, we and our collaboration partners may not be able to seek
or obtain regulatory approval for or commercialize our product candidates when expected or at all, and our
business could be substantially harmed.

We will continue to rely upon medical institutions, clinical investigators and contract laboratories to conduct

our trials in accordance with our clinical protocols and in accordance with applicable legal and regulatory
requirements. These third parties play a significant role in the conduct of these trials and the subsequent
collection and analysis of data from the clinical trials. These third parties are not our employees, and except for
remedies available to us under our agreements with such third parties, there is no guarantee that any such third
party will devote adequate time and resources to our clinical trial. If our CRO or any other third parties upon
which we rely for administration and conduct of our clinical trials do not successfully carry out their contractual
duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the
clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory
requirements, or for other reasons, or if they otherwise perform in a substandard manner, our clinical trials may
be extended, delayed, suspended or terminated, and we may not be able to complete development of, seek or
obtain regulatory approval for, or successfully commercialize our product candidates. We plan to rely heavily on
these third parties for the execution of clinical trials for products we are developing or may develop in the future,
and will control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of
our clinical trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific
standards, and our reliance on our CRO does not relieve us of our regulatory responsibilities.

We, our CRO and our collaboration partners are required to comply with Good Clinical Practice, or GCP,

which are regulations and guidelines enforced by regulatory authorities around the world for products in clinical

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development. Regulatory authorities enforce these GCP regulations through periodic inspections of clinical trial
sponsors, principal investigators and clinical trial sites. If we, our CRO or our collaboration partners fail to
comply with applicable GCP regulations, the clinical data generated in clinical trials may be deemed unreliable
and submission of marketing applications may be delayed or the regulatory authorities may require us to perform
additional clinical trials before accepting our applications for review or approving marketing applications. We
cannot assure that, upon inspection, a regulatory authority will determine that any of our clinical trials comply or
complied with applicable GCP regulations. In addition, clinical trials must be conducted with product produced
under current Good Manufacturing Practices, or cGMP, regulations, which are enforced by regulatory authorities.
Any failure to comply with these regulations may require us to repeat clinical trials, which would delay the
regulatory approval process. Moreover, our business may be implicated if our CRO violates federal or state fraud
and abuse or false claims laws and regulations or healthcare privacy and security laws.

Comparative clinical trials require a substantial number of patients that can form the basis for generating
statistically significant results. Delays in site initiation or unexpectedly low patient enrollment rates may delay
the results of the clinical trial. CROs may also generate higher costs than anticipated. As a result, our results of
operations and the commercial prospects for our product candidates would be harmed, our costs could increase,
and our ability to generate revenue could be delayed. Further, if our relationship with our CRO is terminated, we
may be unable to enter into arrangements with an alternative CRO on commercially reasonable terms, or at all.
Switching or adding CROs can involve substantial cost and require extensive management time and focus. In
addition, there is a natural transition period when a new CRO commences work. As a result, delays may occur,
which can materially impact our ability to meet our desired clinical development timelines. Although we
carefully manage our relationship with our CROs, there can be no assurance that we will not encounter such
challenges or delays in the future or that these delays or challenges will not have a material adverse impact on
our business, prospects, financial condition or results of operations.

We rely on third parties, and in some cases a single third party, to manufacture nonclinical and clinical
supplies of our product candidates and to store critical components of our product candidates for us. Our
business could be harmed if those third parties fail to provide us with sufficient quantities of product
candidates, or fail to do so at acceptable quality levels or prices.

We do not currently have the infrastructure or capability internally to manufacture supplies of our product

candidates for use in clinical studies, and we lack the resources and the capability to manufacture any of our
product candidates on a clinical or commercial scale. We rely on third-party manufacturers, including our
collaboration partners, Strides Arcolab and Jazz, to manufacture our product candidates for preclinical and
clinical studies. Successfully transferring complicated manufacturing techniques to manufacturing organizations
and scaling up these techniques for commercial quantities will be time consuming and we may not be able to
achieve such transfer. Moreover, the market for contract manufacturing services for protein therapeutics is highly
cyclical, with periods of relatively abundant capacity alternating with periods in which there is little available
capacity. If our need for contract manufacturing services increases during a period of industry-wide production
capacity shortage, we may not be able to produce our product candidates on a timely basis or on commercially
viable terms. Although we generally do not begin a clinical study unless we believe we have a sufficient supply
of a product candidate to complete such study, any significant delay or discontinuation in the supply of a product
candidate for an ongoing clinical study due to the need to replace a third-party manufacturer could considerably
delay completion of our clinical studies, product testing, and potential regulatory approval of our product
candidates, which could harm our business and results of operations.

Reliance on third-party manufacturers entails additional risks, including reliance on the third party for
regulatory compliance and quality assurance, the possible breach of the manufacturing agreement by the third
party, and the possible termination or nonrenewal of the agreement by the third party at a time that is costly or
inconvenient for us. In addition, third-party manufacturers may not be able to comply with cGMP, or similar
regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to
comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions,

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civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products,
operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of
our product candidates or any other product candidates or products that we may develop. Any failure or refusal to
supply the components for our product candidates that are being developed could delay, prevent or impair
clinical development or commercialization efforts. If our manufacturers were to breach or terminate their
manufacturing arrangements with us, the development or commercialization of the affected products or product
candidates could be delayed, which could have an adverse effect on our business. Any change in our
manufacturers could be costly because the commercial terms of any new arrangement could be less favorable and
because the expenses relating to the transfer of necessary technology and processes could be significant.

If any of our product candidates are approved, in order to produce the quantities necessary to meet

anticipated market demand, any manufacturer that we engage may need to increase manufacturing capacity. If we
or our manufacturers are unable to produce our product candidates in sufficient quantities to meet the
requirements for the launch of these products or to meet future demand, our revenue and gross margins could be
adversely affected. Although we currently believe that we and our manufacturers will not have any material
supply issues, we cannot be certain that we will be able to obtain long-term supply arrangements for our product
candidates or materials used to produce them on acceptable terms, if at all. If we are unable to arrange for third-
party manufacturing, or to do so on commercially reasonable terms, we may not be able to complete
development of our products or market them.

We also rely on third parties to store master and working cell banks for our product candidates. We have
master and working cell banks and believe we would have adequate backup should any cell bank be lost in a
catastrophic event. However, it is possible that we could lose multiple cell banks and have our manufacturing
severely impacted by the need to replace the cell banks, which could materially and adversely affect our
business, financial condition and results of operations.

We rely on third-party suppliers, and in some instances a single third-party supplier, for the manufacture and
supply of certain materials in our protein production services, and these suppliers could cease to manufacture
the materials, go out of business or otherwise not perform as anticipated.

We rely on third-party suppliers for our protein production services and in some instances a single third-

party supplier, for the manufacture and supply of certain materials. We currently rely, and expect to continue to
rely, on a single-source supplier for the manufacture and supply of CRM197. To meet these demands, our
supplier is in the process of increasing production capacity, and we also have established a repository in the
United States that is capable of storing a safety supply of CRM197 and the CRM197 cell bank. Furthermore, we
have taken steps to identify alternate sources of supply sufficient to support future needs; however, there may be
delays in switching to these alternative suppliers if our contract with primary sources are terminated without
notice. Regardless of the foregoing alternative measures, we cannot guarantee that we will have an adequate
supply of CRM197. If we are unable to secure adequate quantities of CRM197 from our primary supplier, from
potential secondary suppliers or from our safety supply, we may be required to identify additional suppliers. If
we are required to engage additional suppliers, we may not be able to enter into an alternative supply
arrangement on commercially reasonable terms, or at all. Even if we are able to identify additional suppliers and
enter into agreements on commercially reasonable terms, we may incur delays associated with identifying and
qualifying additional suppliers and negotiating the terms of any supply contracts. These delays could adversely
impact our business and negatively affect profitability of our protein production services.

We have entered into collaborations with third parties in connection with the development of certain of our
product candidates. Even if we believe that the development of our technology and product candidates is
promising, our partners may choose not to proceed with such development.

Our existing agreements with our collaboration partners, including our agreements with Strides Arcolab and

Jazz, are generally subject to termination by the counterparty on short notice upon the occurrence of certain

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circumstances. Accordingly, even if we believe that the development of product candidates is worth pursuing,
our partners may choose not to continue with such development. If any of our collaborations are terminated, such
as the termination of our collaboration with Pfizer in August 2016, we may be required to devote additional
resources to the development of our product candidates or seek a new collaboration partner on short notice, and
the terms of any additional collaboration or other arrangements that we establish may not be favorable to us.

We are also at risk that our collaborations or other arrangements may not be successful. Factors that may

affect the success of our collaborations include the following:

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•

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•

our collaboration partners may incur financial and cash flow difficulties that force them to limit or
reduce their participation in our joint projects;

our collaboration partners may be pursuing alternative technologies or developing alternative products
that are competitive to our technology and products, either on their own or in partnership with others;

our collaboration partners may terminate their collaboration with us, which could make it difficult for
us to attract new partners or adversely affect perception of us in the business and financial
communities; and

our collaboration partners may pursue higher priority programs or change the focus of their
development programs, which could affect their commitment to us.

If we cannot maintain successful collaborations, our business, financial condition and operating results may

be adversely affected.

If we are unable to maintain our commercial supply agreements with key customers purchasing CRM197 or if
third-party distributors of our reagent proteins fail to perform as expected, sales revenue could decline.

We primarily sell CRM197 directly to biopharmaceutical companies and currently have several commercial

supply agreements in place for long-term supply of CRM197. To establish and maintain relationships with
customers, we believe we need to maintain adequate supplies of CRM197, remain price competitive, comply
with regulatory regulations and provide high quality products. If we are unable to establish and maintain
arrangements for the sale of CRM197, our revenue and profits would decline.

Although we sell our protein reagents through multiple sales channels, including our ecommerce website,
we also sell our protein reagents to some of our customers through third-party distributors. Many of such third
parties also market and sell products from our competitors. Our third-party distributors may terminate their
relationships with us at any time, or with short notice. Our future performance will also depend, in part, on our
ability to attract additional third-party distributors that will be able to market protein reagents effectively,
especially in markets in which we have not previously distributed our protein reagents. If our current third-party
distributors fail to perform as expected, our revenue and results of operations could be harmed.

Risks Relating to Our Intellectual Property

Our collaboration partners may assert ownership or commercial rights to inventions we develop from our use
of the materials which they provide to us, or otherwise arising from our collaboration.

We collaborate with several companies and institutions with respect to research and development matters.

Also, we rely on numerous third parties to provide us with materials that we use to develop our technology. If we
cannot successfully negotiate sufficient ownership, licensing and/or commercial rights to any inventions that
result from our use of any third-party collaborator’s materials, or if disputes arise with respect to the intellectual
property developed with the use of a collaborator’s materials, or data developed in a collaborator’s study, our
ability to capitalize on the market potential of these inventions or developments may be limited or precluded
altogether.

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If our efforts to protect our intellectual property related to our platform technology and our current or future
product candidates are not adequate, we may not be able to compete effectively in our market.

We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the

intellectual property related to our current product candidates and our development programs. If we do not
adequately protect our intellectual property, competitors may be able to use our technologies and erode or negate
any competitive advantage we may have, which could harm our business and ability to achieve profitability. In
particular, our success depends in large part on our ability to obtain and maintain patent protection in the
United States and other countries with respect to our platform and product candidates. However, we may not be
able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.
We may also fail to identify patentable aspects of our research and development before it is too late to obtain
patent protection. Any disclosure to or misappropriation by third parties of our confidential proprietary
information could enable competitors to quickly duplicate or surpass our technological achievements, eroding
our competitive position in our market.

The patentability of inventions, and the validity, enforceability and scope of patents in the biotechnology

and pharmaceutical industry involve complex legal and scientific questions and can be uncertain. This
uncertainty includes changes to the patent laws through either legislative action to change statutory patent law or
court action that may reinterpret existing law in ways affecting the scope or validity of issued patents. The patent
applications that we own or license may fail to result in issued patents in the United States or foreign countries.
There is a substantial amount of prior art in the biotechnology and pharmaceutical fields, including scientific
publications, patents and patent applications. Our ability to obtain and maintain valid and enforceable patents
depends on whether the differences between our technology and the prior art allow our technology to be
patentable over the prior art. We may be unaware of certain prior art relating to our patent applications and
patents, which could prevent a patent from issuing from a pending patent application, or result in an issued patent
being invalidated. Even if the patents do successfully issue, third parties may challenge the validity,
enforceability or scope of such issued patents or any other issued patents we own or license, which may result in
such patents being narrowed, invalidated or held unenforceable.

Patents granted by the European Patent Office may be opposed by any person within nine months from the

publication of their grant and, in addition, may be challenged before national courts at any time. Furthermore,
even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual
property or prevent others from designing around our claims. If the breadth or strength of protection provided by
the patents and patent applications we hold, license or pursue with respect to our product candidates is
threatened, it could threaten our ability to commercialize our product candidates. In addition, recent changes to
the patent laws of the United States provide additional procedures for third parties to challenge the validity of
issued patents based on patent applications filed after March 15, 2013. If the breadth or strength of protection
provided by the patents and patent applications we hold or pursue with respect to our current or future product
candidates is challenged, then it could threaten our ability to commercialize our current or future product
candidates, and could threaten our ability to prevent competitive products from being marketed. Further, if we
encounter delays in our clinical trials, the period of time during which we could market our current or future
product candidates under patent protection would be reduced. Since patent applications in the United States and
most other countries are confidential for a period of time after filing, we cannot be certain that we were the first
to either (i) file any patent application related to our product candidates, or (ii) invent any of the inventions
claimed in our patents or patent applications. Furthermore, for applications filed before March 16, 2013, or
patents issuing from such applications, an interference proceeding can be provoked by a third party, or instituted
by the United States Patent and Trademark Office, or USPTO, to determine who was the first to invent any of the
subject matter covered by the patent claims of our applications and patents. As of March 16, 2013, the
United States transitioned to a “first-to-file” system for deciding which party should be granted a patent when
two or more patent applications are filed by different parties claiming the same invention. A third party that files
a patent application in the USPTO before us could therefore be awarded a patent covering an invention of ours
even if we had made the invention before it was made by the third party.

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The change to “first-to-file” from “first-to-invent” is one of the changes to the patent laws of the United

States resulting from the Leahy-Smith America Invents Act, or the Leahy-Smith Act, signed into law
on September 16, 2011. Among some of the other significant changes to the patent laws are changes that limit
where a patentee may file a patent infringement suit and provide opportunities for third parties to challenge any
issued patent in the USPTO. It is not yet clear what, if any, impact the Leahy-Smith Act will have on the
operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties
and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued
patents, all of which could have a material adverse effect on our business and financial condition.

Even where laws provide protection, costly and time-consuming litigation could be necessary to enforce and

determine the scope of our proprietary rights, and the outcome of such litigation would be uncertain. Moreover,
any actions we may bring to enforce our intellectual property against our competitors could provoke them to
bring counterclaims against us, and some of our competitors have substantially greater intellectual property
portfolios than we have.

If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be
materially adversely affected and our business would be harmed.

In addition to the protection afforded by patents, we also rely on trade secret protection and confidentiality

agreements to protect proprietary know-how that may not be patentable, processes for which patents may be
difficult to obtain or enforce and any other elements of our product development processes that involve
proprietary know-how, information or technology that is not covered by patents.

As part of our efforts to protect our trade secrets and other confidential information, we require our

employees, consultants, collaborators and advisors to execute confidentiality agreements upon the
commencement of their relationships with us. These agreements require that all confidential information
developed by the individual or made known to the individual by us during the course of the individual’s
relationship with us be kept confidential and not disclosed to third parties. These agreements, however, may not
provide us with adequate protection against improper use or disclosure of confidential information, and these
agreements may be breached. Adequate remedies may not exist in the event of unauthorized use or disclosure of
our confidential information. We also note in this respect that trade secret protection in foreign countries may not
provide protection to the same extent as federal and state laws in the United States. A breach of confidentiality
could significantly affect our competitive position. In addition, in some situations, these agreements may conflict
with, or be subject to, the rights of third parties with whom our employees, consultants, collaborators or advisors
have previous employment or consulting relationships. To the extent that our employees, consultants or
contractors use any intellectual property owned by others in their work for us, disputes may arise as to the rights
in any related or resulting know-how and inventions. Also, third parties, including our competitors, may
independently develop substantially equivalent proprietary information and technologies or otherwise lawfully
gain access to our trade secrets and other confidential information. In such a case, we would have no right to
prevent such third parties from using such proprietary information or technologies to compete with us, which
could harm our competitive position.

If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be
harmed.

Our research, development and commercialization activities may infringe or otherwise violate or be claimed

to infringe or otherwise violate patents owned or controlled by other parties. Our competitors have developed
large portfolios of patents and patent applications in fields relating to our business and it may not always be clear
to industry participants, including us, which patents cover various types of products or methods of use. There
may also be patent applications that have been filed but not published that, when issued as patents, could be
asserted against us. The coverage of patents is subject to interpretation by the courts, and the interpretation is not
always uniform. If we are sued for patent infringement, we would need to demonstrate that our product

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candidates, products or methods either do not infringe the patent claims of the relevant patent or that the patent
claims are invalid, and we may not be able to do this. Proving that a patent is invalid is difficult. For example, in
the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the
presumption of validity enjoyed by issued patents. Also in proceedings before courts in Europe, the burden of
proving invalidity of the patent usually rests on the party alleging invalidity. Third parties could bring claims
against us that would cause us to incur substantial expenses and, if successful against us, could cause us to pay
substantial damages. Further, if a patent infringement suit were brought against us, we could be forced to stop or
delay research, development, manufacturing or sales of the product or product candidate that is the subject of the
suit.

As a result of patent infringement claims, or to avoid potential claims, we may choose or be required to seek
licenses from third parties. These licenses may not be available on acceptable terms, or at all. Even if we are able
to obtain a license, the license would likely obligate us to pay license fees or royalties or both, and the rights
granted to us might be nonexclusive, which could result in our competitors gaining access to the same intellectual
property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect
of our business operations, if, as a result of actual or threatened patent infringement claims, we are unable to
enter into licenses on acceptable terms.

There has been substantial litigation and other proceedings regarding patent and other intellectual property

rights in the pharmaceutical industry. In addition to infringement claims against us, we may become a party to
other patent litigation and other proceedings, including interference, derivation or post-grant proceedings
declared or granted by the USPTO and similar proceedings in foreign countries, regarding intellectual property
rights with respect to our current or future products. Third parties may submit applications for patent term
extensions in the United States and/or supplementary protection certificates in the European Union member
States seeking to extend certain patent protection which, if approved, may interfere with or delay the launch of
one or more of our biosimilar or vaccine products. The cost to us of any patent litigation or other proceeding,
even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of
such litigation or proceedings more effectively than we can because of their substantially greater financial
resources. Patent litigation and other proceedings may also absorb significant management time. Uncertainties
resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to
compete in the marketplace. The occurrence of any of the foregoing could have a material adverse effect on our
business, financial condition or results of operations.

We may become involved in lawsuits to protect or enforce our inventions, patents or other intellectual property
or the patents of our licensors, which could be expensive and time consuming.

Competitors may infringe our intellectual property, including our patents or the patents of our licensors. In
addition, one or more of our third-party collaborators may have submitted, or may in the future submit, a patent
application to the USPTO without naming a lawful inventor that developed the subject matter in whole or in part
while under an obligation to execute an assignment of rights to us. As a result, we may be required to file
infringement or inventorship claims to stop third-party infringement, unauthorized use, or to correct inventorship.
This can be expensive, particularly for a company of our size, and time-consuming. Any claims that we assert
against perceived infringers could also provoke these parties to assert counterclaims against us alleging that we
infringe their intellectual property rights. In addition, in an infringement proceeding, a court may decide that a
patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at
issue on the grounds that our patent claims do not cover its technology or that the factors necessary to grant an
injunction against an infringer are not satisfied.

An adverse determination of any litigation or other proceedings could put one or more of our patents at risk
of being invalidated, held unenforceable or interpreted narrowly and could put our patent applications at risk of
not issuing.

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Interference, derivation or other proceedings brought at the USPTO or any foreign patent authority may be
necessary to determine the priority or patentability of inventions with respect to our patent applications or those
of our licensors or collaborators. Litigation or USPTO proceedings brought by us may fail. An unfavorable
outcome in any such proceedings could require us to cease using the related technology or to attempt to license
rights to it from the prevailing party, or could cause us to lose valuable intellectual property rights. Our business
could be harmed if the prevailing party does not offer us a license on commercially reasonable terms, if any
license is offered at all. Even if we are successful, domestic or foreign litigation or USPTO or foreign patent
office proceedings may result in substantial costs and distraction to our management. We may not be able, alone
or with our licensors or collaborators, to prevent misappropriation of our trade secrets, confidential information
or proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the
United States.

Furthermore, because of the substantial amount of discovery required in connection with intellectual
property litigation or other proceedings, there is a risk that some of our confidential information could be
compromised by disclosure during this type of litigation or proceedings. In addition, during the course of this
kind of litigation or proceedings, there could be public announcements of the results of hearings, motions or
other interim proceedings or developments or public access to related documents. If investors perceive these
results to be negative, the market price for our common stock could be significantly harmed.

We may not be able to globally protect our intellectual property rights.

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would
be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be
less extensive than those in the United States. In addition, the laws of some foreign countries do not protect
intellectual property rights to the same extent as federal and state laws in the United States and in some cases
may even force us to grant a compulsory license to competitors or other third parties. Consequently, we may not
be able to prevent third parties from practicing our inventions in all countries outside the United States, or from
selling or importing products made using our inventions in and into the United States or other jurisdictions.
Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop
their own products and further, may export otherwise infringing products to territories where we have patent
protection, but enforcement is not as strong as that in the United States. These products may compete with our
products and our patents or other intellectual property rights may not be effective or sufficient to prevent them
from competing.

Many companies have encountered significant problems in protecting and defending intellectual property
rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do
not favor the enforcement of patents and other intellectual property protection, particularly those relating to
biopharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of
competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in
foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our
business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at
risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits
that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful.
Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain
a significant commercial advantage from the intellectual property that we develop or license.

In addition, our ability to protect and enforce our intellectual property rights may be adversely affected by

unforeseen changes in domestic and foreign intellectual property laws.

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Obtaining and maintaining patent protection depends on compliance with various procedural, document
submission, fee payment and other requirements imposed by governmental patent agencies, and our patent
protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or

applications will be due to be paid to the USPTO and various governmental patent agencies outside of the
United States in several stages over the lifetime of the patents and/or applications. The USPTO and various non-
U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment
and other similar provisions during the patent application process. In many cases, an inadvertent lapse can be
cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are
situations in which noncompliance can result in abandonment or lapse of the patent or patent application,
resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors
might be able to use our technologies and this circumstance would have a material adverse effect on our
business.

We may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade
secrets of former or other employers.

Many of our employees and consultants, including our senior management, have been employed or retained

by other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
Although we try to ensure that our employees and consultants do not use the proprietary information or know-
how of others in their work for us, we may be subject to claims that we or these employees or consultants have
used or disclosed intellectual property, including trade secrets or other proprietary information, of any such
employee’s or consultant’s former or other employer. We are not aware of any material threatened or pending
claims related to these matters, but in the future litigation may be necessary to defend against such claims. If we
fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual
property rights or personnel. Even if we are successful in defending against such claims, litigation could result in
substantial costs and be a distraction to management.

Risks Related to Government Regulation

The approval processes of the FDA, EMA, and comparable foreign authorities are lengthy, time consuming
and inherently unpredictable, and if we and our collaborators are ultimately unable to obtain regulatory
approval for our product candidates, our business will be substantially harmed.

The research, development, testing, manufacturing, labeling, packaging, approval, promotion, advertising,

storage, marketing, distribution, post-approval monitoring and reporting, and export and import of drug and
biologic products are subject to extensive regulation by the FDA and other regulatory authorities in the
United States, by the EMA and EEA Competent Authorities in the EEA, and by other regulatory authorities in
other countries, which regulations differ from country to country. Neither we nor any collaboration partner is
permitted to market PF708, PF582 or any future product candidates in the United States until approval from the
FDA is received, or in the EEA until we receive EU Commission or EEA Competent Authority approvals. The
time required to obtain approval from regulatory authorities is unpredictable, typically takes many years
following the commencement of clinical trials, and depends upon numerous factors, including the substantial
discretion of such regulatory authorities. In addition, approval policies, regulations, or the type and amount of
clinical data necessary to gain approval may change during the course of a product candidate’s clinical
development and may vary among jurisdictions, which may cause delays in the approval or the decision not to
approve an application. We and our collaboration partners have not submitted any market application to
regulatory authorities or obtained regulatory approval for any product candidate and it is possible that none of
our existing product candidates or any product candidates we may seek to develop in the future will ever obtain
regulatory approval.

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Applications for our product candidates could fail to receive regulatory approval for many reasons,

including but not limited to the following:

•

•

•

•

the data collected from clinical studies of our product candidates may not be sufficient to support the
submission of a biologics license application, or BLA; a new drug application, or NDA, under the
505(b)(2) section of the Food, Drug, and Cosmetic Act; a biosimilar product application under the
351(k) pathway of the PHSA, a biosimilar marketing authorization under Article 6 of Regulation (EC)
No. 726/2004 and/or Article 10(4) of Directive 2001/83/EC in the EEA, or other submission or to
obtain regulatory approval in the United States, the EEA, or elsewhere;

regulatory authorities may disagree with the design or implementation of our clinical trials and may, at
any time, determine that the regulatory pathway that we have committed to for PF708, PF582 or any
future product candidate is inappropriate;

the population studied in the clinical program may not be sufficiently broad or representative to assure
efficacy and safety in the full population for which we seek approval;

regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical
trials;

• we may be unable to demonstrate to the satisfaction of regulatory authorities that a product candidate’s

risk-benefit ratio for its proposed indication is acceptable;

•

•

regulatory authorities may fail to approve the manufacturing processes, test procedures and
specifications, or facilities of third-party manufacturers with whom we contract for clinical and
commercial supplies; and

the approval policies or regulations of regulatory authorities may significantly change in a manner that
renders our clinical data insufficient for approval.

This lengthy approval process as well as the unpredictability of future clinical trial results may result in our

failing to seek or obtain regulatory approval to market PF708, PF582 or any other product candidates, which
would significantly harm our business, results of operations and prospects. Moreover, any delays in the
commencement or completion of clinical testing could significantly impact our product development costs and
could result in the need for additional financing.

In addition, even if we or our collaborators were to obtain approval, regulatory authorities may approve any
of our product candidates for fewer or more limited indications than requested, may grant approval contingent on
the performance of costly post- marketing clinical trials, or may approve a product candidate with a label that
does not include the labeling claims necessary or desirable for the successful commercialization of that product
candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product
candidates.

If we or our collaborators fail to obtain approval for our two most advanced product candidates or if our two
most advanced product candidates are not commercially successful, we may have to curtail our product
development programs and our business would be materially harmed.

We have invested a significant portion of our time, financial resources and efforts in the development of our

two most advanced product candidates, PF708 and PF582. The clinical and commercial success of our product
candidates will depend on a number of factors, including the following:

•

•

timely and successful completion of all necessary clinical trials and our immunogenicity/
pharmacokinetic study in subjects with osteoporosis for PF708, which may be significantly slower or
cost more than we currently anticipate and will depend substantially upon the accurate and satisfactory
performance of third-party contractors, including our collaborators;

our ability to find a suitable collaboration partner to develop PF582 or our ability to obtain substantial
additional sources of funding to develop PF582 as currently contemplated;

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•

timely receipt of necessary marketing approvals from the FDA, the EU Commission, and similar
foreign regulatory authorities;

• maintaining an acceptable safety and adverse event profile of our products following approval;

•

achieving and maintaining compliance with all regulatory requirements applicable to our product
candidates or any approved products;

• making arrangements with third-party manufacturers for, or establishing, commercial manufacturing

capabilities;

•

•

•

•

•

launching commercial sales of our products, if and when approved, whether alone or in collaboration
with others;

obtaining and maintaining patent and trade secret protection and regulatory exclusivity, where
available, for our product candidates;

the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative
and competing treatments;

acceptance of our products, if and when approved, by patients, the medical community and third-party
payors; and

the ability to raise additional capital on acceptable terms to achieve our goals.

If we and our collaboration partners are unable to seek and obtain regulatory approval for any of our product

candidates in a timely manner or at all, we may never realize revenue from these products and we may have to
curtail our other product development programs. As a result, our business, financial condition and results of
operations would be materially harmed.

Our ability to market our products in the United States may be significantly delayed or prevented by the
BPCIA patent dispute resolution mechanism.

The Biologics Price Competition and Innovation Act of 2009, Title VII, Subtitle A of the Patent Protection

and Affordable Care Act, Pub.L.No.111-148, 124 Stat.119, Sections 7001-02 signed into law March 23, 2010,
and codified in 42 U.S.C. §262, or the BPCIA, created an elaborate and complex patent dispute resolution
mechanism for biosimilars that could prevent us from launching our product candidates in the United States or
could substantially delay such launches. The BPCIA mechanism required for 351(k) biosimilar applicants may
pose greater risk as compared to the litigation risk to which we might be exposed under a traditional 351(a) BLA
regulatory pathway.

The BPCIA sets forth patent disclosure and briefing that are demanding and time-sensitive. The following is

an overview of the patent exchange and patent briefing procedures set forth in the BPCIA:

• Disclosure of the Biosimilar Application. Within 20 days after the FDA publishes a notice that its
application has been accepted for review, a 351(k) biosimilar applicant must provide a copy of its
application to the originator.

•

•

Identification of Pertinent Patents. Within 60 days of the date of receipt of the application the
originator must identify patents owned or controlled by the originator which it believes could be
asserted against the biosimilar applicant.

Statement by the Biosimilar Applicant. Following the receipt of the originator’s patent list, the
biosimilar applicant must state either that it will not market its product until the relevant patents have
expired or alternatively provide its arguments that the patents are invalid, unenforceable or would not
be infringed by the proposed biosimilar product candidate. The biosimilar applicant may also provide
the originator with a list of patents it believes the brand-name firm could assert against the reference
product.

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•

•

•

Statement by the Originator. In the event the biosimilar applicant has asserted that the patents are
invalid, unenforceable or would not be infringed by the proposed follow-on product, the originator
must provide the biosimilar applicant with a response within 60 days. The response must provide the
legal and factual basis of the opinion that such patent will be infringed by the commercial marketing of
the proposed biosimilar.

Patent Resolution Negotiations. If the originator provides its detailed views that the proposed
biosimilar would infringe valid and enforceable patents, then the parties are required to engage in good
faith negotiations to identify which of the discussed patents will be the subject of a patent infringement
action. If the parties agree on the patents to be litigated, the brand-name firm must bring an action for
patent infringement within 30 days.

Simultaneous Exchange of Patents. If those negotiations do not result in an agreement within 15 days,
then the biosimilar applicant must notify the originator of how many patents (but not the identity of
those patents) that it wishes to litigate. Within five days, the parties are then required to exchange lists
identifying the patents to be litigated. The number of patents identified by the originator may not
exceed the number provided by the biosimilar applicant. However, if the biosimilar applicant
previously indicated that no patents should be litigated, then the originator may identify one patent.

• Commencement of Patent Litigation. The originator must then commence patent infringement

litigation within 30 days. That litigation will involve all of the patents on the originator’s list and all of
the patents on the follow-on applicant’s list. The follow-on applicant must then notify the FDA of the
litigation. The FDA must then publish a notice of the litigation in the Federal Register.

• Notice of Commercial Marketing. The BPCIA requires the biosimilar applicant to provide notice to the
originator 180 days in advance of its first commercial marketing of its proposed follow-on biologic.
The originator is allowed to seek a preliminary injunction blocking such marketing based upon any
patents that either party had preliminarily identified, but were not subject to the initial phase of patent
litigation. The litigants are required to “reasonably cooperate to expedite such further discovery as is
needed” with respect to the preliminary injunction motion.

Biosimilar companies such as ours have the option of applying for U.S. regulatory approval for our products

under either a traditional 351(a) BLA approval route, or under the recently enacted streamlined 351(k) approval
route established by the BPCIA. The factors underpinning such a decision are extremely complex and involve,
among other things, balancing legal risk (in terms of, e.g., the degree and timing of exposure to potential patent
litigation by the originator) versus regulatory risks (in terms of, e.g., the development costs and the differing
scope of regulatory approval that may be afforded under 351(a) versus 351(k)).

A significant legal risk in pursuing regulatory approval under the 351(k) regulatory approval route is that the

above-summarized patent exchange process established by the BPCIA could result in the initiation of patent
infringement litigation prior to FDA approval of a 351(k) application, and such litigation could result in blocking
the market entry of our products. In particular, while the 351(k) route is more attractive to us (versus 351(a)) for
reasons related to development time and costs and the potential broader scope of eventual regulatory approval for
our proposed biosimilar candidates, the countervailing risk in such a regulatory choice is that the complex patent
exchange process mandated by the BPCIA could ultimately prevent or substantially delay us from launching our
products in the United States.

Moreover, the disclosure process set forth in Step 1 of the process outlined above, which is directed to
disclosure by the biosimilar applicant of not only its regulatory application but also the applicant’s manufacturing
process, has the potential to afford originators an easier path than traditional infringement litigation for
developing any factual grounds they may require to support allegations of infringement. The rules established in
the BPCIA’s patent dispute procedures (versus the rules governing traditional patent infringement litigation)
place biosimilar firms at a significant disadvantage by affording originators a much easier mechanism for factual
discovery, thereby increasing the risk that a biosimilar product could be blocked from the market more quickly
than under traditional patent infringement litigation processes.

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Preparing for and conducting the patent exchange, briefing and negotiation process outlined above will
require extraordinarily sophisticated legal counseling and extensive planning, all under extremely tight deadlines.
Moreover, it may be difficult for us to secure such legal support if large, well-funded originators have already
entered into engagements with highly qualified law firms or if the most highly qualified law firms choose not to
represent biosimilar applicants due to their long standing relationships with originators. Furthermore, we could
be at a serious disadvantage in this process as an originator company, as competitors may be able to apply
substantially greater legal and financial resources to this process than we could.

We are aware that some biosimilar companies, namely Sandoz International GmbH, or Sandoz, a subsidiary
of Novartis AG, and Celltrion, Inc. have engaged in legal challenges against originators to establish their right to
bring declaratory judgment actions against such originators outside the complex framework of the BPCIA patent
exchange rules in order to challenge the validity of the originators’ patents prior to the filing of any biosimilar
regulatory application. For example, in the Sandoz case against the originator Amgen (relating to Sandoz’
proposed etanercept (Enbrel) biosimilar) the federal district court ruled that Sandoz did not have the right to
bring a declaratory judgment action against Amgen to challenge the validity of certain Amgen-controlled patents
directed to Enbrel, but instead determined that Sandoz must use the patent exchange mechanism established in
the BPCIA. Sandoz appealed this decision to the United States Court of Appeals for the Federal Circuit, and on
December 5, 2014 the Federal Circuit Court ruled that Sandoz had not met the legal requirements to pursue a
declaratory judgment action against Amgen. The Federal Circuit court did not address whether the patent
resolution mechanism established in the BPCIA would preclude Sandoz from filing its declaratory judgment
action against Amgen if and when it files an FDA application under the BPCIA for its etanercept biosimilar.

In October 2014, Amgen filed suit in federal district court against Sandoz alleging that Sandoz unlawfully

refused to follow the patent resolution provisions of the BPCIA in connection with Sandoz’ July 2014 regulatory
approval application under 351(k) for its Neupogen (filgrastim) biosimilar, Zarxio. Amgen sought declaratory
and injunctive relief. In October 2014, Amgen also filed a Citizen’s Petition with the FDA asking that the FDA
require biosimilar applicants to comply with the BPCIA by providing to the reference product sponsor a copy of
the biosimilar application accepted for review, together with information that fully describes the manufacture of
the proposed biosimilar product, within 20 days after being informed by the FDA that the biosimilar application
has been accepted for review. On March 19, 2015, the district court refused Amgen’s request to enjoin Sandoz’
launch of Zarxio and ruled that the patent resolution provisions of the BPCIA (summarized in the prior eight
bullet points) are optional insofar as it is permissible for a 351(k) applicant to decide not to provide its BLA and/
or manufacturing information to the originator. The court also held that a biosimilar applicant need not wait until
it receives BLA approval to provide the 180 prior day notice of commercial marketing set forth in the BPCIA
provisions (see paragraph 8 above), but instead may provide such notice to the originator, if at all, prior to
receiving FDA approval. On March 26, 2015, the FDA denied Amgen’s Citizen’s Petition. On July 21, 2015, a
divided panel of the Federal Circuit issued its first decision interpreting the BPCIA on appeal in the Amgen v.
Sandoz case. The court held that a biosimilar applicant is not required to share its biosimilar application with the
reference product sponsor or follow the patent dispute resolution procedures set forth in the BPCIA. However,
the Federal Circuit appellate court also held that the biosimilar applicant must provide 180 days pre-marketing
notice and cannot do so until after the FDA has “licensed” (approved) the biosimilar product. On February 16,
2016, Sandoz petitioned the United States Supreme Court for certiorari review of this latter holding.

If we file a 351(k) regulatory approval application for one or more of our products, we may consider it

necessary or advisable to adopt the strategy of selecting one or more patents of the originator to litigate in the
above described BPCIA process (for example in steps 3 and 7, of the process, as outlined above), either to assert
our non-infringement of such patents or to challenge their validity; but we may ultimately not be successful in
that strategy and could be prevented from marketing the product in the United States.

Under the complex and uncertain rules of the BPCIA patent provisions, coupled with the inherent

uncertainty surrounding the legal interpretation of any originator patents that might be asserted against us in this
new process, we see substantial risk that the BPCIA process may significantly delay or defeat our ability to
market our products in the United States.

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Our ability to market our therapeutic equivalent products in the United States may be significantly delayed or
prevented by the Hatch-Waxman patent dispute resolution mechanism, including a potential automatic
30 month stay of regulatory approval of our marketing applications.

The Hatch-Waxman Act. The provisions of Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act,

or FFDCA, were created, in part, to help avoid unnecessary duplication of studies already performed on a
previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data
not developed by the New Drug Application, or NDA, applicant. Indeed, an NDA filed under Section 505(b)(2)
is one for which one or more of the investigations relied upon by the applicant for approval were not conducted
by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by
or for whom the investigations were conducted. We are pursuing a Section 505(b)(2) regulatory strategy for our
PF708 product candidate and we plan to reference the Forteo (teriparatide) listed drug which is marketed by Eli
Lilly for the treatment of osteoporosis. It is possible that for one reason or another, we will not be able to
establish that our PF708 product candidate is suitable for approval under the Section 505(b)(2) framework. In
addition, to the extent we rely on certain data and information that was submitted to the FDA related to the safety
of Forteo, the FDA may likely require any approved labeling for PF708 to include certain safety information that
is included in the Forteo label, including contraindications, warnings, precautions and other safety information.

The owner of an NDA for a branded drug product may list with the FDA certain patents whose claims
allegedly cover the applicant’s branded product. Each of the patents listed in the application for the drug is then
published in the Orange Book. Any applicant who files a 505(b)(2) NDA referencing a drug listed in the Orange
Book must certify to the FDA that: (1) no patent information on the drug product that is the subject of the
application has been submitted to the FDA, referred to as a Paragraph I Certification; (2) such patent has expired,
referred to as a Paragraph II Certification; (3) the date on which such patent expires, referred to as a Paragraph III
Certification; or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the
drug product for which the application is submitted, referred to as a Paragraph IV Certification.

The applicant may also elect to submit a “section viii” statement certifying that its proposed label does not
contain, or carves out, any language regarding the patented method-of-use rather than certify to a listed method-
of-use patent. An applicant submitting a Paragraph IV Certification must provide notice to each owner of the
patent that is the subject of the certification and to the holder of the approved branded drug to which the
505(b)(2) application references. If the reference branded drug holder and patent owners file a lawsuit directed to
one of the Orange Book listed patents within 45 days of the receipt of the Paragraph IV Certification notice, the
FDA is prohibited from approving the 505(b)(2) application until the earlier of 30 months from the receipt of the
Paragraph IV Certification, expiration of the patent, settlement of the lawsuit, or a decision in the infringement
case that is favorable to the applicant. In the event we commercially launch our PF708 product candidate at a
time when one or more unexpired patents are listed in the Orange Book for a reference listed drug product, we
see substantial risk that the Paragraph IV certification process, including the likelihood of imposition of a 30
month stay and necessity of defending against accusation of patent infringement, may significantly delay or
defeat our ability to competitively market our PF708 product in the United States.

Non-Patent Exclusivity and Approval of Competing Products. Additionally, a 505(b)(2) application also will

not be approved until any applicable non-patent exclusivity listed in the Orange Book for the NDA branded
reference drug has expired as described in further detail below. Market and data exclusivity provisions under the
FFDCA can delay the submission or the approval of certain applications for competing products. In addition to
patent exclusivity, the holder of the NDA for a reference listed drug may be entitled to a period of non-patent
exclusivity, during which the FDA cannot approve another drug application that relies on the listed drug. For
example, a pharmaceutical manufacturer may obtain five years of non-patent exclusivity upon NDA approval of
a new chemical entity, or NCE, which is a drug that contains an active moiety that has not been approved by the
FDA in any other NDA. An “active moiety” is defined as the molecule or ion responsible for the drug
substance’s physiological or pharmacologic action. During the five-year exclusivity period, the FDA cannot
accept for filing any application for the same active moiety and that relies on the FDA’s findings regarding that

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drug; the FDA may accept an application for filing after four years if the 505(b)(2) applicant makes a
Paragraph IV Certification. A drug may obtain a three-year period of exclusivity for a particular condition of
approval, or change to a marketed product, such as a new formulation for a previously approved product, if one
or more new clinical trials, other than bioavailability or bioequivalence studies, was essential to the approval of
the application and was conducted or sponsored by the applicant. Should this occur, the FDA would be precluded
from approving any ANDA that references such product until after that three-year exclusivity period has run.
However, unlike NCE exclusivity, the FDA can accept an application and begin the review process during the
entire exclusivity period.

Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of
earlier studies and trials may not be predictive of future trial results.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain.
Furthermore, we rely on our collaborators, CROs, and clinical trial sites to ensure the proper and timely conduct
of our clinical trials for our product candidates. While we have agreements governing the committed activities of
our collaborators and CROs, we have limited influence over their actual performance. A failure of one or more
clinical trials can occur at any time during the trial process. The results of preclinical studies and early clinical
trials of our product candidates may not be predictive of the results of later-stage clinical trials. Product
candidates that have shown promising results in early studies may still suffer significant setbacks in subsequent
clinical studies. For example, the results generated to date in the clinical trial for PF582 do not ensure that later
clinical trials will demonstrate similar results. There is a high failure rate for drugs and biologics proceeding
through clinical studies, and product candidates in later stages of clinical trials may fail to show the desired
safety and efficacy despite having progressed through preclinical studies and initial clinical trials. A number of
companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to
lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier clinical trials, and we
cannot be certain that we will not face similar setbacks. Even if the clinical trials for our product candidates are
completed, nonclinical and clinical data are often susceptible to varying interpretations and analyses, and the
results may not be sufficient to obtain regulatory approval for our product candidates.

We have in the past and may in the future experience delays in ongoing clinical trials for our product
candidates, and we do not know whether future clinical trials, if any, will begin on time, need to be redesigned,
enroll an adequate number of patients on time or be completed on schedule, if at all. The commencement or
completion of clinical trials can be delayed or aborted for a variety of reasons, including delay or failure to:

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generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of
human clinical studies;

raise sufficient capital to fund a trial;

obtain regulatory approval, or feedback on trial design, necessary to commence a trial;

identify, recruit and train suitable clinical investigators;

reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which
can be subject to extensive negotiation and may vary significantly among different CROs and trial
sites;

obtain institutional review board, or IRB, approval at each site;

identify, recruit, and enroll suitable patients to participate in a trial;

have patients complete a trial or return for post-treatment follow-up;

ensure clinical sites observe trial protocol or continue to participate in a trial;

address any patient safety concerns that arise during the course of a trial;

address any conflicts with new or existing laws or regulations;

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add a sufficient number of clinical trial sites;

• manufacture sufficient quantities of product candidate for use in clinical trials; and

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avoid delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable
quantities of our product candidates for use in clinical studies, or the inability to do any of the
foregoing.

Patient enrollment is a significant factor in the completion of clinical trials and is affected by many factors,

including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility
criteria for the trial, the design of the clinical trial, competing clinical trials and clinicians’ and patients’
perceptions as to the potential advantages of the drug being studied in relation to other available therapies,
including any new drugs or treatments that may be approved for the indications we are investigating.

We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the
institutions in which such trials are being conducted, by the data safety monitoring board, for such trial or by the
FDA or other regulatory authorities. Such authorities may suspend or terminate a clinical trial due to a number of
factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical
protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities
resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to
demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of
adequate funding to continue the clinical trial.

If we or our collaborators experience delays in the completion of, or termination of, any clinical trial of our

product candidates, the commercial prospects of our product candidates may be harmed, and our ability to
generate product revenue from any of these product candidates will be delayed. In addition, any delays in
completing clinical trials for our product candidates will increase our costs, slow down our product candidate
development and approval process and jeopardize our ability to commence product sales and generate revenue.
Any of these occurrences may significantly harm our business, financial condition and prospects. In addition,
many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also
ultimately lead to the denial of regulatory approval of our product candidates.

Even if PF708, PF582 or any of our other product candidates obtain regulatory approval, they may never
achieve market acceptance or commercial success.

Even if we or our collaboration partners obtain FDA or other regulatory approvals, PF708, PF582 or any of
our other product candidates may not achieve market acceptance among physicians and patients, and may not be
commercially successful. The degree and rate of market acceptance of PF708, PF582 or any of our other product
candidates for which we receive approval depends on a number of factors, including:

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the safety and efficacy of the product as demonstrated in clinical trials;

the clinical indications for which the product is approved;

acceptance by physicians, major operators of clinics and patients of the product as a safe and effective
treatment;

proper training and administration of our products by physicians and medical staff;

the potential and perceived advantages of our products over alternative treatments;

the cost of treatment in relation to alternative treatments and willingness to pay for our products, if
approved, on the part of physicians and patients;

relative convenience and ease of administration;

the prevalence and severity of adverse events; and

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the effectiveness of our sales and marketing efforts.

Any failure by our product candidates that obtain regulatory approval to achieve market acceptance or
commercial success would materially adversely affect our results of operations and delay, prevent or limit our
ability to generate revenue and continue our business.

The development, manufacture and commercialization of biosimilar and other therapeutic equivalent products
pose unique risks, and our failure to successfully introduce biosimilar and other therapeutic equivalent
products could have a negative impact on our business and future operating results.

We are actively working to develop multiple biosimilar and other therapeutic equivalent products, including

our two most advanced product candidates, PF708 and PF582. The cost to develop each biosimilar and
therapeutic equivalent product candidate could vary significantly and is highly dependent on the specific
compound and the amount and type of clinical work that will be necessary for regulatory approval. There can be
no assurance that our clinical work will be successful, or that regulatory authorities will not require additional
clinical development beyond that which we have planned. Additionally, we may enter into alliances and
collaborations to fund biosimilar and therapeutic equivalent product research and development activities, and the
success of any such biosimilar or therapeutic equivalent product program may depend on our ability to realize the
benefits under such arrangements. Due to events beyond our control or the risks identified herein, we may be
unable to fund all or some of our internal biosimilar and therapeutic equivalent product research and
development initiatives, which would have an adverse impact on our strategy and growth initiatives.

We intend to pursue market authorization globally when commercially appropriate. Since October 2005, the

European Union has had a regulatory framework for the approval of biosimilar products. As of December 31,
2016, 25 biosimilar medicinal products, less three subsequently withdrawn, have been approved. In the United
States, an abbreviated pathway for approval of biosimilar products was established by the BPCIA, enacted on
March 23, 2010, as part of the Patient Protection and Affordable Care Act. The BPCIA established this
abbreviated pathway under section 351(k) of the Public Health Service Act, or PHSA. Subsequent to the
enactment of the BPCIA, the FDA issued draft guidance regarding the demonstration of biosimilarity as well as
the submission and review of biosimilar applications. However, to date, only four biosimilars have been
approved by the FDA, and no biosimilar product has been designated as interchangeable to the reference drug.
Moreover, market acceptance of biosimilar products in the U.S. is unclear. Numerous states are considering or
have already enacted laws that regulate or restrict the substitution by state pharmacies of biosimilars for
biological products already licensed by the FDA pursuant to BLAs, or “reference products.” Market success of
biosimilar products will depend on demonstrating to patients, physicians, payors, and relevant authorities that
such products are safe and efficacious compared to other existing products.

We will continue to analyze and incorporate into our biosimilar development plans any final regulations

issued by the FDA, pharmacy substitution policies enacted by state governments, and other applicable
requirements established by relevant authorities. The costs of development and approval, along with the
probability of success for our biosimilar product candidates, will be dependent upon application of any laws and
regulations issued by the relevant regulatory authorities.

Biosimilar products may also be subject to extensive patent clearances and patent infringement litigation,
which will likely delay and could prevent the commercial launch of a product. Moreover, the BPCIA prohibits
the FDA from accepting an application for a biosimilar candidate to a reference product within four years of the
reference product’s licensure by the FDA. In addition, the BPCIA provides innovative biologics with twelve
years of exclusivity from the date of their licensure, during which time the FDA cannot approve any application
for a biosimilar candidate to the reference product. For example, the FDA may not be able to approve any
application that we or our collaborators submit for PF582 until twelve years after the original BLA for Lucentis
was approved. However, in his proposed budget for fiscal year 2014, President Obama proposed to cut this 12-
year period of exclusivity down to seven years. He also proposed to prohibit additional periods of exclusivity due

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to minor changes in product formulations, a practice often referred to as “evergreening.” It is possible that
Congress may take these or other measures to reduce or eliminate periods of exclusivity.

The BPCIA is complex and only beginning to be interpreted and implemented by the FDA. As a result, its

ultimate impact, implementation, and meaning is subject to significant uncertainty. Future implementation
decisions by the FDA could result in delays in the development or commercialization of our product candidates
or increased costs to assure regulatory compliance, and could adversely affect our operating results by restricting
or significantly delaying our ability to market new biosimilar products. In the EEA, holders of marketing
authorizations of reference products (for which a marketing authorization was applied for under the centralized
procedure after November 20, 2005, or under the Decentralized, Mutual Recognition and national procedures,
after October 30, 2005) enjoy eight years of data exclusivity during which a follow-on product or biosimilar
marketing authorization applicant cannot rely on the preclinical and clinical data included in the reference
product’s dossier, and ten years of marketing exclusivity during which a follow-on product or biosimilar of the
reference product cannot be placed in the EEA market. The marketing exclusivity period can be extended one
additional year (to 11 years) if a second indication of the reference product with significant clinical benefit is
approved during the eight-year data exclusivity period. The data and marketing exclusivity periods start from the
date of the initial authorization, which for reference medicinal products authorized through the Centralized
Procedure is the date of notification of the marketing authorization decision to the marketing authorization holder
of the reference product. Lucentis was granted a marketing authorization by the EU Commission through the EU
centralized procedure on January 22, 2007.

We may rely on the Animal Rule in conducting trials, which could be time consuming and expensive.

To obtain FDA approval for our vaccine candidate Px563L, we may obtain clinical data from trials in
healthy human subjects that demonstrate adequate safety, and efficacy data from adequate and well-controlled
animal studies under regulations issued by the FDA in 2002, often referred to as the “Animal Rule.” Among
other requirements, the animal studies must establish that the drug or biological product is reasonably likely to
produce clinical benefits in humans. If we use this approach we may not be able to sufficiently demonstrate this
correlation to the satisfaction of the FDA, as these corollaries are difficult to establish and are often unclear.
Because the FDA must agree that data derived from animal studies may be extrapolated to establish safety and
effectiveness in humans, seeking approval under the Animal Rule may add significant time, complexity and
uncertainty to the testing and approval process. The FDA may decide that our data are insufficient for approval
and require additional preclinical, clinical or other studies, refuse to approve Px563L, or place restrictions on our
ability to commercialize the products. In addition, products approved under the Animal Rule are subject to
additional requirements including post-marketing study requirements, restrictions imposed on marketing or
distribution or requirements to provide information to patients. Further, regulatory authorities in other countries
have not, at this time, established an “Animal Rule” equivalent, and consequently there can be no assurance that
we will be able to make a submission for marketing approval in foreign countries based on such animal data.

Additionally, few facilities in the U.S. and internationally may have the capability to test animals involving
exposure to anthrax or otherwise assist us in qualifying the requisite animal models, and we must compete with
other companies for access to this limited pool of highly specialized resources. We therefore may not be able to
secure contracts to conduct the testing in a predictable timeframe or at all.

If we and our collaboration partners are not able to demonstrate biosimilarity of our biosimilar product
candidates to the satisfaction of regulatory authorities, we will not obtain regulatory approval for commercial
sale of our biosimilar product candidates and our future results of operations would be adversely affected.

Our future results of operations depend, to a significant degree, on our and our collaboration partners’

ability to obtain regulatory approval for and commercialize our proposed biosimilar products. To obtain
regulatory approval for the commercial sale of these product candidates, we will be required to demonstrate to
the satisfaction of regulatory authorities, among other things, that our proposed biosimilar products are highly

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similar to biological products already licensed by the FDA pursuant to Biologic License Applications, or BLAs,
notwithstanding minor differences in clinically inactive components, and that they have no clinically meaningful
differences as compared to the marketed biological products in terms of the safety, purity and potency of the
products. In the EEA, the similar nature of a biosimilar and a reference product is demonstrated by
comprehensive comparability studies covering quality, biological activity, safety and efficacy. For example, a
determination of biosimilarity for PF582 will be based on our demonstration of its high similarity to Lucentis.

In addition, the FDA may determine that a proposed biosimilar product is “interchangeable” with a
reference product, meaning that the biosimilar product may be substituted by a pharmacist for the reference
product without the intervention of the health care provider who prescribed the reference product, if the
application includes sufficient information to show that the product is biosimilar to the reference product and that
it can be expected to produce the same clinical result as the reference product in any given patient. If the
biosimilar product may be administered more than once to a patient, the applicant must demonstrate that the risk
in terms of safety or diminished efficacy of alternating or switching between the biosimilar and reference product
is not greater than the risk of using the reference product without such alternation or switch. To make a final
determination of biosimilarity or interchangeability, regulatory authorities may require additional confirmatory
information beyond what we and our collaboration partners plan to initially submit in our applications for
approval, such as more in-depth analytical characterization, animal testing, or further clinical studies. Provision
of sufficient information for approval may prove difficult and expensive. We cannot predict whether any of our
biosimilar product candidates will meet regulatory authority requirements for approval as a biosimilar or
interchangeable product. To date, the FDA has not approved a biosimilar product as being interchangeable to the
reference drug.

Analytical assessments can identify potential differences between biosimilar candidates and reference

products. Differences in the analytical assessments may require clinical studies to reduce the residual
uncertainties. In the event that regulatory authorities require us to conduct additional clinical trials or other
lengthy processes, the commercialization of our proposed biosimilar products could be delayed or prevented.
Delays in the commercialization of, or the inability to obtain regulatory approval for, these products could
adversely affect our operating results by restricting or significantly delaying our introduction of new biosimilars.

If other biosimilars of Lucentis or other therapeutic equivalent products to Forteo are approved and
successfully commercialized before PF708 or PF582, our business would suffer.

Other companies may seek approval to manufacture and market biosimilar versions of Lucentis or
therapeutic equivalent product versions of Forteo. If other biosimilars of Lucentis or therapeutic equivalent
product versions of Forteo, are approved and successfully commercialized before PF708 or PF582, we may never
achieve significant market share for PF708 or PF582, our revenue would be reduced and, as a result, our
business, prospects and financial condition could suffer. In addition, the first biosimilar determined to be
interchangeable with a particular reference product for any condition of use is eligible for a period of market
exclusivity that delays an FDA determination that a second or subsequent biosimilar product is interchangeable
with that reference product for any condition of use until the earlier of: (1) one year after the first commercial
marketing of the first interchangeable product; (2) 18 months after resolution of a patent infringement suit
instituted under 42 U.S.C. § 262(l)(6) against the applicant that submitted the application for the first
interchangeable product, based on a final court decision regarding all of the patents in the litigation or dismissal
of the litigation with or without prejudice; (3) 42 months after approval of the first interchangeable product, if a
patent infringement suit instituted under 42 U.S.C. § 262(l)(6) against the applicant that submitted the application
for the first interchangeable product is still ongoing; or (4) 18 months after approval of the first interchangeable
product if the applicant that submitted the application for the first interchangeable product has not been sued
under 42 U.S.C. § 262(l)(6). A determination that another company’s product is interchangeable with Lucentis
prior to approval of PF582 may therefore delay the potential determination that PF582 is interchangeable with
the reference product, which may materially adversely affect our results of operations and delay, prevent or limit
our ability to generate revenue.

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Failure to obtain regulatory approval in each regulatory jurisdiction would prevent us and our collaboration
partners from marketing our products to a larger patient population and reduce our commercial opportunities.

In order to market our products in the European Union, the United States and other jurisdictions, we or our

collaboration partners must obtain separate regulatory approvals and comply with numerous and varying
regulatory requirements. The European Medicines Agency is responsible for the centralized procedure for human
medicines. This procedure results in a single marketing authorization that is valid in all European Union
countries, as well as in Iceland, Liechtenstein and Norway. The time required to obtain approval abroad may
differ from that required to obtain FDA approval. The foreign regulatory approval process may include all of the
risks associated with obtaining FDA approval and we may not obtain foreign regulatory approvals on a timely
basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and
approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign
countries or by the FDA. We may not be able to file for regulatory approvals and may not receive necessary
approvals to commercialize our products within the United States or in any market outside the United States.
Failure to obtain these approvals would materially and adversely affect our business, financial condition and
results of operations.

Even if we and our collaboration partners obtain regulatory approvals for our product candidates, we will be
subject to ongoing regulatory review.

Even if we and our collaboration partners obtain regulatory approval for our product candidates, any
products we develop will be subject to ongoing regulatory review with respect to manufacturing, labeling,
packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and
submission of safety, efficacy, and other post-market information, including both federal and state requirements
in the United States and requirements of comparable foreign regulatory authorities. Manufacturers and
manufacturers’ facilities are required to comply with extensive FDA and comparable foreign regulatory authority
requirements, including ensuring that quality control and manufacturing procedures conform to cGMP. As such,
we and our contract manufacturers will be subject to continual and unannounced review and inspections by the
regulatory authorities governing the markets in which we wish to sell our products. Accordingly, we and others
with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance,
including manufacturing, production, and quality control.

Any regulatory approvals that we and our collaboration partners receive for our product candidates may be
subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions
of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 trials, and
surveillance to monitor the safety and efficacy or the safety, purity, and potency of the product candidate. We
will be required to immediately report any serious and unexpected adverse events and certain quality or
production problems with our products to regulatory authorities along with other periodic reports. Any new
legislation addressing drug or biologic product safety issues could result in delays in product development or
commercialization, or increased costs to assure compliance. We and our collaboration partners will have to
comply with requirements concerning advertising and promotion for our products. Promotional communications
with respect to prescription drug and biologic products are subject to a variety of legal and regulatory restrictions
and must be consistent with the information in the product’s approved label. As such, we will not be allowed to
promote our products for indications or uses for which they do not have approval. The holder of an approved
NDA, BLA, 351(k) application or marketing authorization application, or MAA, must submit new or
supplemental applications and obtain prior approval for certain changes to the approved product, product
labeling, or manufacturing process. We could also be asked to conduct post-marketing clinical studies to verify
the safety and efficacy of our products in general or in specific patient subsets. An unsuccessful post-marketing
study or failure to complete such a study could result in the withdrawal of marketing approval.

If a regulatory agency discovers previously unknown problems with a product, such as adverse events of
unanticipated severity or frequency, or problems with the facility where the product is manufactured or disagrees

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with the promotion, marketing or labeling of a product, or if we or our collaboration partners fail to comply with
applicable continuing regulatory requirements, such regulatory agency may impose restrictions on that product or
us, including requiring withdrawal of the product from the market. If we or our collaboration partners fail to
comply with applicable regulatory requirements, a regulatory agency or enforcement authority may subject us to
administrative or judicially imposed sanctions or other actions, including, among other things:

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adverse publicity, fines or warning letters;

civil or criminal penalties;

injunctions;

suspending or withdrawing regulatory approval;

suspending any of our ongoing clinical studies;

refusing to approve pending applications or supplements to approved applications submitted by us;

imposing restrictions on our operations, including closing our contract manufacturers’ facilities; or

seizing or detaining products, or requiring a product recall.

Any government investigation of alleged violations of law could require us to expend significant time and

resources in response, and could generate negative publicity. Any failure to comply with ongoing regulatory
requirements may significantly and adversely affect our ability to commercialize and generate revenue from our
products. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and
our operating results will be adversely affected.

We will also be subject to various health care fraud and abuse laws, including anti-kickback, false claims and
fraud laws, and physician payment transparency laws, and any violations by us of such laws could result in
fines or other penalties.

Although we currently do not have any products on the market, if our product candidates are approved and

we begin commercialization, we will be subject to healthcare regulation and enforcement by the federal
government and the states and EEA and other foreign governments in which we conduct our business. These
laws include, without limitation, state and federal, as well as EEA and other foreign, anti-kickback, fraud and
abuse, false claims, privacy and security and physician sunshine laws and regulations. The federal Anti-Kickback
Statute prohibits the offer, receipt, or payment of remuneration in exchange for or to induce the referral of
patients or the use of products or services that would be paid for in whole or part by Medicare, Medicaid or other
federal health care programs. Remuneration has been broadly defined to include anything of value, including
cash, improper discounts, and free or reduced price items and services. The government has enforced the Anti-
Kickback Statute to reach large settlements with healthcare companies based on sham research or consulting and
other financial arrangements with physicians. Further, the Affordable Care Act, among other things, amended the
intent requirement of the federal Anti-Kickback Statute and certain criminal statutes governing healthcare fraud.
A person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it. In
addition, the Affordable Care Act provided that the government may assert that a claim including items or
services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for
purposes of the FCA or federal civil money penalties statute. Many states have similar laws that apply to their
state health care programs as well as private payors. Violations of the anti-kickback laws can result in exclusion
from federal health care programs and substantial civil and criminal penalties. The FCA imposes liability on
persons who, among other things, present or cause to be presented false or fraudulent claims for payment by a
federal health care program. The FCA has been used to prosecute persons submitting claims for payment that are
inaccurate or fraudulent, that are for services not provided as claimed, or for services that are not medically
necessary. Actions under the FCA may be brought by the Attorney General or as a qui tam action by a private
individual in the name of the government. Violations of the FCA can result in significant monetary penalties and
treble damages. The federal government is using the FCA, and the accompanying threat of significant liability, in

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its investigation and prosecution of pharmaceutical and biotechnology companies throughout the country, for
example, in connection with the promotion of products for unapproved uses and other sales and marketing
practices. The government has obtained multi-million and multi-billion dollar settlements under the FCA in
addition to individual criminal convictions under applicable criminal statutes. In addition, companies have been
forced to implement extensive corrective action plans, and have often become subject to consent decrees or
corporate integrity agreements, severely restricting the manner in which they conduct their business. Given the
significant size of actual and potential settlements, it is expected that the government will continue to devote
substantial resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud
and abuse laws. If our future marketing or other arrangements were determined to violate anti-kickback or related
laws, including the FCA, then our revenue could be adversely affected, which would likely harm our business,
financial condition, and results of operations.

In addition, there has been a recent trend of increased federal and state regulation of payments made to
physicians and other healthcare providers. The Affordable Care Act, among other things, imposed new reporting
requirements on drug commercial manufacturers for payments and other transfers of value made by them to
physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their
immediate family members. Failure to submit required information may result in civil monetary penalties of up
to an aggregate of $150,000 per year (or up to an aggregate of $1 million per year for “knowing failures”), for all
payments, transfers of value or ownership or investment interests that are not timely, accurately and completely
reported in an annual submission. Drug manufacturers must submit reports by the 90th day of each calendar year.
Certain states also mandate implementation of commercial compliance programs, impose restrictions on device
manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other
remuneration to physicians.

The shifting commercial compliance environment and the need to build and maintain robust and expandable
systems to comply with different compliance and/or reporting requirements in multiple jurisdictions increase the
possibility that a healthcare company may violate one or more of the requirements. If our operations are found to
be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to
penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or
restructuring of our operations, exclusion from participation in federal and state healthcare programs and
imprisonment, any of which could adversely affect our ability to operate our business and our financial results.

Also, the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit
companies and their intermediaries from making improper payments to non-U.S. officials for the purpose of
obtaining or retaining business. We cannot assure investors that our internal control policies and procedures will
protect us from reckless or negligent acts committed by our employees, future distributors, partners, collaborators
or agents. Violations of these laws, or allegations of such violations, could result in fines, penalties or
prosecution and have a negative impact on our business, results of operations and reputation.

Legislative or regulatory healthcare reforms in the United States may make it more difficult and costly for us
to obtain regulatory approval of PF708, PF582 or any future product candidates and to produce, market, and
distribute our products after approval is obtained, if any.

From time to time, legislation is drafted and introduced in Congress that could significantly change the
statutory provisions governing the regulatory approval, manufacturing, and marketing of regulated products or
the reimbursement thereof. In addition, FDA regulations and guidance may be revised or reinterpreted by the
FDA in ways that may significantly affect our business and our products. Any new regulations or guidance, or
revisions or reinterpretations of existing regulations or guidance, may impose additional costs or lengthen FDA
review times for PF708, PF582 or any future product candidates. We cannot determine how changes in
regulations, statutes, policies, or interpretations when and if issued, enacted or adopted, may affect our business
in the future. Such changes could, among other things, require:

•

changes to manufacturing methods;

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•

•

recalls, replacements, or discontinuance of one or more of our products; and

additional recordkeeping.

Such changes would likely require substantial time and impose significant costs, and could materially harm
our business and our financial results. In addition, delays in receipt of or failure to receive regulatory clearances
or approvals for any future products would harm our business, financial condition, and results of operations.

If efforts by manufacturers of reference products to delay or limit the use of biosimilars and therapeutic
equivalent products are successful, our sales of biosimilar and other therapeutic equivalent products may
suffer.

Many manufacturers of reference products have increasingly used legislative, regulatory and other means in

attempts to delay regulatory approval of and competition from biosimilars and therapeutic equivalent products.
These efforts have included sponsoring legislation to prevent pharmacists from substituting biosimilars and
therapeutic equivalent products for prescribed reference products or to make such substitutions more difficult by
establishing notification, recordkeeping, and/or other requirements, as well as seeking to prevent manufacturers
of biosimilars and therapeutic equivalent products from referencing the branded products in biosimilar and
therapeutic equivalent product labels and marketing materials. If these or other efforts to delay or block
competition are successful, we may be unable to sell our biosimilar and therapeutic equivalent product
candidates, which could have a material adverse effect on our sales and profitability.

Our and our collaboration partners’ future sales will be dependent on the availability and level of coverage
and reimbursement from third-party payors who continue to implement cost-cutting measures and more
stringent reimbursement standards.

In the United States and internationally, our and our collaboration partners’ ability to generate revenue on
future sales of our products will be dependent, in significant part, on the availability and level of coverage and
reimbursement from third-party payors, such as state and federal governments and private insurance plans.
Insurers have implemented cost-cutting measures and other initiatives to enforce more stringent reimbursement
standards and likely will continue to do so in the future. These measures include the establishment of more
restrictive formularies and increases in the out-of-pocket obligations of patients for such products. In addition,
particularly in the U.S. and increasingly in other countries, we will be required to provide discounts and pay
rebates to state and federal governments and agencies in connection with purchases of our products that are
reimbursed by such entities.

In addition, in the United States, the full impact of recent healthcare reform and other changes in the
healthcare industry and in healthcare spending is currently unknown. In March 2010, the Patient Protection and
Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, collectively referred to
as the Affordable Care Act, was enacted with a goal of reducing the cost of healthcare and substantially changing
the way healthcare is financed by both government and private insurers. The Affordable Care Act, among other
things, subjected biologic products to potential competition by lower-cost biosimilars and follow-on products,
addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate
Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increased the
minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the
rebate program to individuals enrolled in Medicaid managed care organizations, established annual fees and
taxes on manufacturers of certain prescription drugs, and created a new Medicare Part D coverage gap discount
program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of
applicable reference product drugs to eligible beneficiaries during their coverage gap period as a condition for the
manufacturer’s outpatient drugs to be covered under Medicare Part D.

Other legislative changes have been proposed and adopted in the U.S. since the Affordable Care Act was

enacted. On August 2, 2011, the Budget Control Act of 2011 created measures for spending reductions by

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Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction
of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the
legislation’s automatic reduction to several government programs. This included aggregate reductions of
Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013 and will stay in
effect through 2024 unless additional Congressional action is taken. On January 2, 2013, the American Tax Payer
Relief Act, or ATRA, was signed into law, which, among other things, further reduced Medicare payments to
several providers, including hospitals. We expect that additional healthcare reform measures will be adopted in
the future, any of which could limit the amounts that federal, state and foreign governments will pay for
healthcare products and services, which could result in reduced demand for our products, if approved, or
additional pricing pressures. Furthermore, the current presidential administration and Congress are also expected
to attempt broad sweeping changes to the current health care laws. We face uncertainties that might result from
modification or repeal of any of the provisions of the Affordable Care Act, including as a result of current and
future executive orders and legislative actions. The impact of those changes on us and potential effect on
biosimilar manufacturing industry as a whole is currently unknown. But, any changes to the Affordable Care Act
are likely to have an impact on our results of operations, and may have a material adverse effect on our results of
operations. We cannot predict what other healthcare programs and regulations will ultimately be implemented at
the federal or state level or the effect of any future legislation or regulation in the United States may have on our
business.

Foreign governments tend to impose strict price controls, which may adversely affect our revenue, if any.

In some foreign countries, the pricing of prescription pharmaceuticals is subject to governmental control. In
these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of
marketing approval for a product. Our existing or future collaboration partners, if any, may elect to reduce the
price of our products in order to increase the likelihood of obtaining reimbursement approvals which could
adversely affect our revenues and profits. To obtain reimbursement or pricing approval in some countries, we or
our collaboration partners may also be required to conduct a clinical trial that compares the cost-effectiveness of
our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in
scope or amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected.

Risks Relating to Owning Our Common Stock

The market price of our stock may fluctuate significantly, and investors may have difficulty selling their
shares.

Our stock is currently traded on NYSE MKT, but we can provide no assurance that we will be able to
maintain an active trading market on NYSE MKT or any other exchange in the future. The trading volume of our
stock tends to be low relative to our total outstanding shares, and we have several stockholders, including
affiliated stockholders, who hold substantial blocks of our stock. As of December 31, 2016, we had 23,429,501
shares of common stock outstanding, and stockholders holding at least 5% of our stock, individually or with
affiliated persons or entities, collectively beneficially owned or controlled approximately 56% of such shares.
Sales of large numbers of shares by any of our large stockholders could adversely affect our trading price,
particularly given our relatively small historic trading volumes. If stockholders holding shares of our common
stock sell, indicate an intention to sell, or if it is perceived that they will sell, substantial amounts of their
common stock in the public market, the trading price of our common stock could decline.

Since shares of our common stock were sold in our initial public offering in July 2014 at a price of $6.00 per

share, our stock price has ranged from $5.28 to $24.41 through December 31, 2016. In addition to the factors
discussed in this “Risk Factors” section and elsewhere in this annual report on Form 10-K factors that may cause
volatility in our share price include:

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actual or anticipated quarterly variation in our results of operations or the results of our competitors;

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announcements by us or our competitors of new commercial products, significant contracts,
commercial relationships or capital commitments;

issuance of new or changed securities analysts’ reports or recommendations for our stock;

developments or disputes concerning our intellectual property or other proprietary rights;

changes to our organization and our search for a permanent chief executive officer;

commencement of, or our involvement in, litigation;

• market conditions in the relevant market;

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reimbursement or legislative changes in the relevant market;

failure to complete significant sales;

regulatory developments that may impact our product candidates;

any future sales of our common stock or other securities;

any major change to the composition of our board of directors or management; and

general economic conditions and slow or negative growth of our markets.

The stock market in general and market prices for the securities of biopharmaceutical companies like ours in

particular, have from time to time experienced volatility that often has been unrelated to the operating
performance of the underlying companies. These broad market and industry fluctuations may adversely affect the
market price of our common stock, regardless of our operating performance.

We may be subject to securities litigation, which is expensive and could divert management attention.

The market price of our common stock has been and will likely continue to be volatile, and in the past
companies that have experienced volatility in the market price of their stock have been subject to securities class
action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could
result in substantial costs and divert our management’s attention from other business concerns, which could
seriously harm our business.

If securities or industry analysts publish unfavorable research about our business or cease to cover our
business, our stock price and/or trading volume could decline.

The trading market for our common stock may rely, in part, on the research and reports that equity research

analysts publish about us and our business. We do not have any control of the analysts or the content and
opinions included in their reports. The price of our stock could decline if one or more equity research analysts
downgrade our stock or issue other unfavorable commentary or research. If one or more equity research analysts
cease coverage of our company or fails to publish reports on us regularly, demand for our stock could decrease,
which in turn could cause our stock price or trading volume to decline.

If we sell shares of our common stock in future financings, stockholders may experience immediate dilution
and, as a result, the market price of our common stock may decline.

We may from time to time issue additional shares of common stock at a discount from the current trading
price of our common stock. As a result, our stockholders would experience immediate dilution upon the purchase
of any shares of our common stock sold at such discount. In addition, as opportunities present themselves, we
may enter into financing or similar arrangements in the future, including the issuance of debt securities, preferred
stock or common stock. If we issue common stock or securities convertible into common stock, our common
stockholders would experience additional dilution and, as a result, the market price of our common stock may
decline.

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Sales of substantial amounts of our common stock in the public markets, or the perception that such sales
might occur, could reduce the price that our common stock might otherwise attain and may dilute your voting
power and your ownership interest in us.

Sales of a substantial number of shares of our common stock in the public market, or the perception that
these sales might occur, could depress the market price of our common stock and could impair our ability to raise
capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on
the prevailing market price of our common stock.

As of December 31, 2016, one holder of approximately 2.3 million shares, or approximately 10%, of our
outstanding shares, has rights, subject to some conditions, to require us to file registration statements covering
the sale of their shares or to include their shares in registration statements or prospectus supplements that we file
or have filed for ourselves or other stockholders. We also register the offer and sale of all shares of common
stock that we may issue under our equity compensation plans.

Furthermore, certain of our executive officers have adopted, and other directors and executive officers may

in the future adopt, written plans, known as “Rule 10b5-1 Plans,” under which they have contracted, or may in
the future contract, with a broker to sell shares of our common stock on a periodic basis to diversify their assets
and investments. Sales of substantial amounts of our common stock in the public markets, including, but not
limited to, sales made by our executive officers and directors pursuant to Rule 10b5-1 Plans, or the perception
that these sales could occur, could cause the market price of our common stock to decline.

We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging
growth companies could make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups, or JOBS, Act

enacted in April 2012, and may remain an “emerging growth company” for up to five years following the
completion of our initial public offering, although, if we have more than $1.0 billion in annual revenue, if the
market value of our common stock that is held by non-affiliates exceeds $700 million as of December 31 of any
year, or we issue more than $1.0 billion of non-convertible debt over a three-year period before the end of that
five-year period, we would cease to be an “emerging growth company” as of the following December 31. For as
long as we remain an “emerging growth company,” we are permitted and intend to rely on exemptions from
certain disclosure requirements that are applicable to other public companies that are not “emerging growth
companies.” These exemptions include:

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•

•

•

not being required to comply with the auditor attestation requirements in the assessment of our internal
control over financial reporting;

not being required to comply with any requirement that may be adopted by the Public Company
Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the financial statements;

reduced disclosure obligations regarding executive compensation; and

exemptions from the requirements of holding a nonbinding advisory vote on executive compensation
and shareholder approval of any golden parachute payments not previously approved.

We have taken advantage of reduced reporting burdens in our reports filed with the Securities and Exchange

Commission, or SEC. In addition, the JOBS Act provides that an emerging growth company can take advantage
of an extended transition period for complying with new or revised accounting standards, delaying the adoption
of these accounting standards until they would apply to private companies. We have elected to avail ourselves of
this exemption and, as a result, our financial statements may not be comparable to the financial statements of
reporting companies who are required to comply with the effective dates for new or revised accounting standards
that are applicable to public companies. We cannot predict whether investors will find our common stock less

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attractive as a result of our reliance on these exemptions. If some investors find our common stock less attractive
as a result, there may be a less active trading market for our common stock and the market price of our common
stock may be reduced or more volatile.

We have identified a material weakness in our internal control over financial reporting. If we do not
remediate the material weakness in our internal control over financial reporting, we may not be able to
accurately report our financial results or file our periodic reports in a timely manner, which may cause
investors to lose confidence in our reported financial information and may lead to a decline in the market
price of our stock.

In connection with our audit committee investigation as more fully described in Item 9A, “Controls and

Procedures”, we identified a material weakness in our internal control over financial reporting. A material
weakness is a significant deficiency, or a combination of significant deficiencies, in internal control over
financial reporting such that it is reasonably possible that a material misstatement of the annual or interim
financial statements will not be prevented or detected on a timely basis. The material weakness that we identified
related to a failure to maintain an effective control environment as our former Chief Executive Officer failed to
set an appropriate “Tone at the Top.” As further described in Item 9A, “Controls and Procedures”, the material
weakness was identified in connection with our Audit Committee Investigation, which found violations of our
Board Approval Process Policy and related violations of our Code of Ethics and Conduct by our former Chief
Executive Officer. The investigation determined that our former Chief Executive Officer had not acted in
accordance with our Board Approval Process Policy and Code of Ethics and Conduct as a result of his failure to
comply with certain board approval procedures for third-party contracts.

As further described in Item 9A, “Controls and Procedures—Remediation Plan and Activities”, we have

undertaken steps to improve our internal controls over financial reporting. If we are unable to successfully
remediate our existing or any future material weaknesses in our internal control over financial reporting, the
accuracy and timing of our financial reporting may be adversely affected, we may be unable to maintain
compliance with securities laws and NYSE MKT listing requirements regarding the timely filing of periodic
reports, investors may lose confidence in our financial reporting, and our stock price may decline.

Additionally, our independent registered public accounting firm is not required to and did not perform an
evaluation of our internal control over financial reporting during any period in accordance with the provisions of
the Sarbanes-Oxley Act due to a transition period established by the rules of the SEC for newly public companies
that have not lost their “emerging growth company” status as defined in the JOBS Act. Had our independent
registered public accounting firm performed an evaluation of our internal control over financial reporting in
accordance with the provisions of the Sarbanes-Oxley Act, additional control deficiencies amounting to
significant deficiencies or material weaknesses may have been identified. We cannot be certain as to when we
will be able to implement the requirements of Section 404 of the Sarbanes-Oxley Act. If we fail to implement the
requirements of Section 404 in a timely manner, we might be subject to sanctions or investigation by regulatory
agencies such as the SEC. In addition, failure to comply with Section 404 or the report by us of a significant
deficiency or material weakness may cause investors to lose confidence in our financial statements, and the
trading price of our common stock may decline. If we fail to remedy any significant deficiency or material
weakness, our financial statements may be inaccurate, our access to the capital markets may be restricted and the
trading price of our common stock may decline.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

We generated a tax net operating loss for 2016. Our previous tax net operating losses offset the taxable

income related to the Pfizer agreement in 2015. The 2016 net operating loss will carry forward to offset future
taxable income, if any, until such unused losses expire. Under Sections 382 and 383 of the Internal Revenue
Code of 1986, as amended, if a corporation undergoes an “ownership change,” generally defined as a greater than
50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period,

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the corporation’s ability to use its pre-change net operating loss carryforwards, or NOLs, and other pre-change
tax attributes (such as research tax credits) to offset its post-change income or taxes may be limited. We may
experience ownership changes in the future as a result of shifts in our stock ownership. As a result, if or when we
earn net taxable income, our ability to use our pre-change NOLs to offset such taxable income may be subject to
limitations. Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes.
As a result, even if we attain profitability, we may be unable to use a material portion of our NOLs and other tax
attributes, which could adversely affect our future cash flows.

We will incur increased costs as a result of operating as a public company and our management will be
required to devote substantial time to new compliance initiatives and corporate governance practices including
maintaining an effective system of internal control over financial reporting.

As a public company, and increasingly after we are no longer an “emerging growth company,” we will incur

significant legal, accounting and other expenses that we did not incur as a private company. In addition, the
Sarbanes-Oxley Act and rules subsequently implemented by the SEC, and the NYSE MKT impose numerous
requirements on public companies, including establishment and maintenance of effective disclosure and financial
controls and corporate governance practices. Also, the Securities Exchange Act of 1934, as amended, or the
Exchange Act, requires, among other things, that we file annual, quarterly and current reports with respect to our
business and operating results. Our management and other personnel will need to devote a substantial amount of
time to comply with these laws and regulations. These requirements have increased and will continue to increase
our legal, accounting, and financial compliance costs and have made and will continue to make some activities
more time consuming and costly. For example, we expect these rules and regulations to make it more difficult
and more expensive for us to obtain director and officer liability insurance, and we may be required to incur
substantial costs to maintain the same or similar coverage. These rules and regulations could also make it more
difficult for us to attract and retain qualified persons to serve on our board of directors or our board committees
or as executive officers. These rules and regulations are often subject to varying interpretations, in many cases
due to their lack of specificity, and, as a result, their application in practice may evolve over time as new
guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding
compliance matters and higher costs necessitated by ongoing revisions to disclosure and changing governance
practices.

The Sarbanes-Oxley Act requires, among other things, that we assess the effectiveness of our internal

control over financial reporting annually and the effectiveness of our disclosure controls and procedures
quarterly. In particular, Section 404(a) of the Sarbanes-Oxley Act requires us to perform system and process
evaluation and testing of our internal control over financial reporting to allow management to report on the
effectiveness of our internal control over financial reporting. Section 404(b) of Sarbanes-Oxley Act, or
Section 404(b), also requires our independent registered public accounting firm to attest to the effectiveness of
our internal control over financial reporting. As an “emerging growth company,” we are availing ourselves of the
exemption from the requirement that our independent registered public accounting firm attest to the effectiveness
of our internal control over financial reporting under Section 404(b). However, we may no longer avail ourselves
of this exemption when we are no longer an “emerging growth company.” When our independent registered
public accounting firm is required to undertake an assessment of our internal control over financial reporting, the
cost of our compliance with Section 404(b) will correspondingly increase. Our compliance with applicable
provisions of Section 404 requires us and will continue to require us to incur substantial accounting expense and
expend significant management time on compliance-related issues as we implement additional corporate
governance practices and comply with reporting requirements.

Furthermore, investor perceptions of our company may suffer if deficiencies are found, such as the material
weakness described in Item 9A, “Controls and Procedures,” and this could cause a decline in the market price of
our stock. Irrespective of any required compliance with Section 404, any failure of our internal control over
financial reporting could have a material adverse effect on our stated operating results and harm our reputation. If
we are unable to implement these requirements effectively or efficiently, it could harm our operations, financial

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reporting, or financial results and could result in an adverse opinion on our internal controls from our
independent registered public accounting firm.

Our directors, executive officers and principal stockholders will continue to have substantial control over us
and could limit investors’ ability to influence the outcome of key transactions, including transactions that
would cause a change of control.

As of December 31, 2016, our executive officers, directors and stockholders who owned more than 5% of

our outstanding common stock and their respective affiliates beneficially owned or controlled approximately
60% of the outstanding shares of our common stock. Accordingly, these executive officers, directors and
stockholders and their respective affiliates, acting as a group, have substantial influence over the outcome of
corporate actions requiring stockholder approval, including the election of directors, any merger, consolidation or
sale of all or substantially all of our assets or any other significant corporate transactions. These stockholders
may therefore delay or prevent a change of control of us, even if such a change of control would benefit our other
stockholders. The significant concentration of stock ownership may adversely affect the trading price of our
common stock due to investors’ perception that conflicts of interest may exist or arise.

Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful
third-party claims against us and may reduce the amount of money available to us.

Our amended and restated certificate of incorporation and amended and restated bylaws provide that we will
indemnify our directors and officers, in each case to the fullest extent permitted by Delaware law. In addition, as
permitted by Section 145 of the Delaware General Corporation Law, our amended and restated bylaws and our
indemnification agreements that we have entered into with our directors and officers provide that:

• We will indemnify our directors and officers for serving us in those capacities, or for serving other
business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law
provides that a corporation may indemnify such person if such person acted in good faith and in a
manner such person reasonably believed to be in or not opposed to the best interests of the registrant
and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct
was unlawful.

• We may, in our discretion, indemnify employees and agents in those circumstances where

indemnification is permitted by applicable law.

• We are required to advance expenses, as incurred, to our directors and officers in connection with

defending a proceeding, except that such directors or officers shall undertake to repay such advances if
it is ultimately determined that such person is not entitled to indemnification.

• We will not be obligated pursuant to our amended and restated bylaws to indemnify a person with

respect to proceedings initiated by that person against us or our other indemnitees, except with respect
to proceedings authorized by our board of directors or brought to enforce a right to indemnification.

• The rights conferred in our amended and restated bylaws are not exclusive, and we are authorized to

enter into indemnification agreements with our directors, officers, employees and agents and to obtain
insurance to indemnify such persons.

• We may not retroactively amend our amended and restated bylaw provisions to reduce our

indemnification obligations to directors, officers, employees and agents.

To the extent that a claim for indemnification is brought by any of our directors or officers, it would reduce

the amount of funds available for use in our business.

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Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us,
which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to
replace or remove our current management and limit the market price of our common stock.

Provisions in our certificate of incorporation and bylaws may have the effect of delaying or preventing a

change of control or changes in our management. Our amended and restated certificate of incorporation and
amended and restated bylaws include provisions that:

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authorize our board of directors to issue, without further action by the stockholders, up to 10,000,000
shares of undesignated preferred stock;

require that any action to be taken by our stockholders be effected at a duly called annual or special
meeting and not by written consent;

specify that special meetings of our stockholders can be called only by our board of directors, the
chairman of the board of directors, or the chief executive officer;

establish an advance notice procedure for stockholder approvals to be brought before an annual
meeting of our stockholders, including proposed nominations of persons for election to our board of
directors;

establish that our board of directors is divided into three classes, Class I, Class II and Class III, with
each class serving staggered three-year terms;

provide that our directors may be removed only for cause;

provide that vacancies on our board of directors may be filled only by a majority of directors then in
office, even though less than a quorum;

specify that no stockholder is permitted to cumulate votes at any election of directors; and

require a super-majority of votes to amend certain of the above-mentioned provisions.

These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current
management by making it more difficult for stockholders to replace members of our board of directors, which is
responsible for appointing the members of our management. In addition, because we are incorporated in
Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which
limits the ability of stockholders owning in excess of 15% of our outstanding voting stock to merge or combine
with us.

We have broad discretion in the use of the net proceeds from our public offerings and may not use them
effectively.

We have broad discretion as to how to spend and invest the proceeds from our public offerings, and we may

spend or invest these proceeds in a way with which our stockholders disagree. Accordingly, investors will need
to rely on our judgment with respect to the use of these proceeds and these uses may not yield a favorable return
to our stockholders. In addition, until the net proceeds are used, they may be placed in investments that do not
produce significant income or that may lose value.

With the exception of the issuance of shares of common stock to our preferred stockholders in connection with
the payment of all accrued and unpaid dividends in connection with our initial public offering, we do not
anticipate paying any cash dividends in the foreseeable future.

At the closing of our initial public offering, our board of directors issued shares of common stock to pay all

accrued but unpaid dividends on our convertible preferred stock. As of July 29, 2014, there were cumulative
unpaid dividends of $7.3 million for our Series A-1 and Series A-2 convertible preferred stock. Based on the
initial public offering price of $6.00 per share and the offering closing on July 29, 2014, we issued
1,217,784 shares of common stock to the holders of our outstanding preferred stock prior to the offering in

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satisfaction of these accrued dividends through July 28, 2014. With the exception of this dividend, we do not
anticipate paying cash dividends on any classes of our capital stock in the foreseeable future. We currently intend
to retain our future earnings for the foreseeable future to fund the development and growth of our business. As a
result, capital appreciation, if any, of our common stock will be the sole source of gain on an investment in our
common stock for the foreseeable future.

Item 1B. Unresolved Staff Comments

None.

Item 2.

Properties

As of December 31, 2016, we leased a total of approximately 46,959 square feet of office and laboratory
space located at 10790 and 10788 Roselle Street, San Diego, CA 92121. The lease expires on March 31, 2024.
We believe that our existing facilities are adequate to meet our business requirements for the foreseeable future
and that additional space will be available on commercially reasonable terms, if required.

Item 3.

Legal Proceedings

In the normal course of business, we are from time to time involved in legal proceedings or potential legal

proceedings, including matters involving employment, intellectual property, or others. Although the results of
litigation and claims cannot be predicted with certainty, we currently believe that the final outcome of any
currently pending matters would not have a material adverse effect on our business, operating results, financial
condition, or cash flows. Regardless of the outcome, litigation can have an adverse impact on us because of
defense and settlement costs, diversion of management resources, and other factors.

Item 4. Mine Safety Disclosures.

Not applicable.

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PART II

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of

Equity Securities

Market Information and Holders of Record

Our common stock has been listed on the NYSE MKT under the symbol “PFNX” since July 24, 2014. Prior
to that date, there was no public trading market for our common stock. The following table sets forth the high and
low sales price per share of our common stock as reported on the NYSE MKT for the periods indicated:

Year Ended December 31, 2015:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
First Quarter
Second Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Third Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fourth Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Year Ended December 31, 2016:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
First Quarter
Second Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Third Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fourth Quarter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

High

Low

$18.72
21.01
24.41
18.23

$12.37
11.35
10.82
11.35

$ 6.40
12.74
14.15
10.87

$ 6.50
5.79
7.06
7.18

As of February 28, 2017, we had 59 holders of record of our common stock. The actual number of stockholders
is greater than this number of record holders and includes stockholders who are beneficial owners but whose
shares are held in street name by brokers and other nominees. This number of holders of record also does not
include stockholders whose shares may be held in trust by other entities.

Dividends

With the exception of common stock issued in connection with the payment of all accrued but unpaid
dividends upon the conversion of all preferred stock upon the completion of our initial public offering, we have
not made any distributions on our common stock and do not intend to make any distributions on our common
stock for the foreseeable future. Instead, we anticipate that all of our earnings in the foreseeable future will be
used for the operation and growth of our business.

Stock Performance Graph

This performance graph shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the Exchange Act), or incorporated by reference into any filing of Pfenex Inc. under
the Securities Act of 1933, as amended, or the Exchange Act.

The graph below shows the cumulative total stockholder return assuming the investment of $100 as of the

close on July 24, 2014, the first day of trading for Pfenex Inc.’s common stock, (and the reinvestment of
dividends thereafter) in each of (i) Pfenex Inc.’s common stock, and (ii) the ARCA Biotechnology Index. The
comparisons in the graph below are based upon historical data and are not indicative of, or intended to forecast,
future performance of our common stock or the index. The prices are as of the close of PFNX’s first trading day
to the close at December 31, 2016.

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$450 

$400 

$350 

$300 

$250 

$200 

$150 

$100 

$50 

$-

6/30/2014

7/31/2014

8/31/2014

12/31/2014
11/30/2014
9/30/2014
1/31/2015
10/31/2014

2/28/2015

3/31/2015

4/30/2015

5/31/2015

6/30/2015

7/31/2015

8/31/2015

11/30/2015
10/31/2015
1/31/2016
12/31/2015
9/30/2015

2/29/2016

3/31/2016

4/30/2016

5/31/2016

6/30/2016

7/31/2016

8/31/2016

9/30/2016
11/30/2016
12/31/2016
10/31/2016

PFNX

ARCA Biotechnology Index (BTK)

Securities Authorized for Issuance Under Equity Compensation Plans

The information required by this Item regarding equity compensation plans is incorporated by reference to

the information set forth in PART III Item 12 of this Annual Report on Form 10-K.

Recent Sales of Unregistered Securities and Use of Proceeds

(a) Sales of Unregistered Securities

None.

(b) Use of Proceeds

In April 2015, we completed a follow-on offering in which we sold 2,610,000 shares of common stock at

the public offering price of $15.50 per share. After deducting underwriting discounts and commissions and
estimated offering expenses payable by us, the proceeds were approximately $37.3 million. There has been no
material change in the planned use of proceeds from our public offering as described in our final prospectus filed
with the SEC on April 24, 2015 pursuant to Rule 424(b).

(c) Issuer Purchases of Equity Securities

We did not repurchase any shares of our common stock during the three months ended December 31, 2016.

Item 6.

Selected Financial Data

The following selected historical financial data below should be read in conjunction with Item 7,
“Management’s Discussion and Analysis of Financial Condition and Results of Operations,” our financial
statements, and the related notes appearing in Item 8, “Financial Statements and Supplementary Data”, of this
Annual Report on Form 10-K to fully understand factors that may affect the comparability of the information
presented below.

The consolidated statements of operations data for the years ended December 31, 2016, 2015 and 2014 and

the consolidated balance sheet data as of December 31, 2016 and 2015 are derived from our audited financial

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statements appearing in Item 8, “Financial Statements and Supplementary Data,” of this Annual Report on Form
10-K. The consolidated statements of operations data for the years ended December 31, 2013 and 2012 and the
consolidated balance sheet data as of December 31, 2014, 2013 and 2012 are derived from audited financial
statements not included in this Annual Report on Form 10-K. Our historical results are not necessarily indicative
of the results to be expected in the future.

Years Ended December 31,

2016

2015

2014

2013

2012

Revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expense:
Cost of revenues(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Selling, general and administrative . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . .
Research and development(1)

(in thousands, except for per
share data)
$10,644

$ 9,583

$11,914

$11,294

$60,194

5,313
17,340
32,418

4,640
14,598
18,183

7,233
9,003
4,125

6,423
6,698
5,490

7,253
6,876
1,792

Total expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

55,071

37,421

20,361

18,611

15,921

Income (loss) from operations . . . . . . . . . . . . . . . . . . . . . . .
Other income (expense), net . . . . . . . . . . . . . . . . . . . . .

Income (loss) before income taxes . . . . . . . . . . . . . . . . . . . .
Income tax benefit (expense) . . . . . . . . . . . . . . . . . . . .

5,123
149

5,272
209

(27,838)
74

(27,764)
(452)

(9,717)
(77)

(9,794)
—

(6,697)
(36)

(6,733)
2,671

(4,627)
(7)

(4,634)
2,041

Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 5,481

$(28,216) $ (9,794) $ (4,062) $ (2,593)

Effective preferred stock dividends(2) . . . . . . . . . . . . . . . . . .

$ — $ — $ — $ (1,695) $ (1,589)

Net income (loss) attributable to common stockholders . . .

$ 5,481

$(28,216) $ (9,794) $ (5,757) $ (4,182)

Basic and diluted net income (loss) per share attributable to
. . . . . . . . . . . . . . . . . . . . . . . . . .

common stockholders(3)

Basic weighted-average shares used to compute net income
(loss) per share attributable to common stockholders . . .

Diluted weighted-average shares used to compute net
income (loss) per share attributable to common
stockholders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

0.23

$

(1.26) $ (1.04) $ (3.76) $ (2.84)

23,389

22,376

9,441

1,531

1,474

23,688

22,376

9,441

1,531

1,474

(1) Please refer to Note 1 of our consolidated financial statements for an explanation of the method used to

recognize cost of revenues and research and development expense.

(2) The holders of our convertible preferred stock were entitled to cumulative dividends prior and in preference
to our common stock. Because the holders of our convertible preferred stock were entitled to participate in
dividends, net loss attributable to common stockholders was equal to net loss adjusted for convertible
preferred stock dividends for the period. Immediately upon the closing of our IPO, all outstanding shares of
our redeemable convertible preferred stock, or our convertible preferred stock, were automatically converted
into an aggregate of 8,634,857 shares of common stock and these holders were issued 1,217,784 shares of
common stock for the payment of all accrued and unpaid dividends through July 28, 2014 in connection
with such conversion based on the initial public offering price of $6.00 per share and the offering closing on
July 29, 2014. See Note 14 to our financial statements for a description of the method used to compute basic
and diluted net loss per share attributable to common stockholders and for a description of convertible
preferred stock, respectively. Please refer to Note 8 of our consolidated financial statements for an
explanation of the cumulative preferred stock dividends.

(3) All share, per-share and related information have been retroactively adjusted, where applicable, to reflect

the impact of a 2.812-for-1 reverse stock split, which was effected on June 27, 2014.

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Other Financial Data

As of December 31,

2016

2015

2014

2013

2012

(in thousands)

Balance Sheet Data: . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash and cash equivalents and short-term

investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts and unbilled receivables, net . . . . . . . . . . . . . .
Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restricted cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property and equipment, net . . . . . . . . . . . . . . . . . . . . . .
Goodwill and intangibles . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 81,501
2,822
—
—
5,246
10,878
2,675

$106,162
2,683
24
3,959
3,179
11,409
4,278

$45,722
1,584
23
3,955
2,310
11,940
5,489

$

5,204
3,461
26
4,029
2,329
12,470
4,294

$ 9,966
2,703
754
1,501
2,681
13,001
2,326

Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$103,122

$131,694

$71,023

$ 31,813

$ 32,932

Current liabilities, excluding debt . . . . . . . . . . . . . . . . . .
Deferred revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Debt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 10,696
12,255
—
26

$

Total liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Redeemable convertible preferred stock . . . . . . . . . . . . .
Stockholders’ equity (deficit) . . . . . . . . . . . . . . . . . . . . .

22,977
—
80,145

6,883
48,095
3,813
1,722

60,513
—
71,181

$ 3,762
201
3,813
3,373

11,149
—
59,874

$

4,757
1,253
3,590
3,484

$ 3,199
2,342
1,140
3,611

13,084
113,180
(94,451)

10,292
42,500
(19,860)

Total liabilities, redeemable convertible preferred stock
and stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . .

$103,122

$131,694

$71,023

$ 31,813

$ 32,932

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in

conjunction with our financial statements and related notes appearing elsewhere in this Annual Report on
Form 10-K. In addition to historical financial information, the following discussion contains forward-looking
statements that reflect our plans, estimates and beliefs. Statements containing words such as “may,” “believe,”
“anticipate,” “expect,” “intend,” “plan,” “project,” “projections,” “business outlook,” “estimate,” or similar
expressions constitute forward-looking statements. Our actual results could differ materially from those
contained in or implied by any forward-looking statements. Factors that could cause or contribute to these
differences include those discussed below, in the section captioned “Risk Factors,” and elsewhere in this Annual
Report on Form 10-K.

Overview

We are a clinical-stage biotechnology company engaged in the development of biosimilar and therapeutic
equivalent products and other high-value and difficult-to-manufacture proteins. Our product candidate selection
strategy is to focus on products with large addressable markets, which are expected to be free of intellectual
property barriers in major markets over our projected approval timelines, and for which our Pfe¯nex Expression
Technology® enables efficient and large scale manufacturing. Our pipeline of product candidates and preclinical
products under development includes six wholly-owned programs, two that are being developed in a joint
venture with Strides Arcolab Limited, a specialty pharmaceutical company, and certain other products that are
being developed in collaboration with Jazz Pharmaceuticals Ireland Limited, or Jazz. In addition, we are also
developing proprietary vaccine candidates that are being funded by the Department of Health and Human
Services and the National Institutes of Health (NIH) within the United States government.

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Our lead product candidates include the following:

PF708 – our teriparatide (Forteo) therapeutic equivalent candidate. PF708 is our therapeutic equivalent

candidate to Forteo, which is marketed by Eli Lilly and Company for the treatment of osteoporosis. Forteo
achieved over $1.4 billion in global product sales in 2015. The PF708 bioequivalence study, conducted in 70
healthy subjects, was completed in the second quarter of 2016 and met its primary objectives. The 90%
confidence intervals of the area-under-the-curve (AUC) and maximum concentration (Cmax) geometric mean
ratios of PF708 versus Forteo were within the 80-125% range required for concluding bioequivalence. We
initiated an immunogenicity/pharmacokinetics study in osteoporosis patients in the fourth quarter of 2016. This
study, along with the positive bioequivalence study, is anticipated to satisfy the filing requirements for PF708
through the 505(b)(2) regulatory pathway. The interim pharmacokinetic data from this study is expected in the
second half of 2017 and the immunogenicity data is expected in the first half of 2018. We believe that the clinical
program in the US may be leveraged for regulatory filings in other geographies, such as the European Union
(EU).

PF582 – our ranibizumab (Lucentis) biosimilar candidate. PF582 is our biosimilar candidate to Lucentis,

which is marketed by Genentech, Inc., a wholly-owned member of the Roche Group, and Novartis AG, for the
treatment of patients with retinal diseases. Lucentis achieved approximately $3.6 billion in global product sales
in 2015. In February 2015, we entered into a development and license agreement with Hospira, Inc., or Hospira,
a subsidiary of Pfizer Inc. (collectively with Hospira, “Pfizer”) for the development and commercialization of
PF582. For PF582, we completed a Phase 1/2 trial in patients with wet age-related macular degeneration, or wet
AMD, with Pfizer. Following Pfizer’s strategic review of the therapeutic focus of its biosimilars pipeline, we
entered into a Termination Agreement (the “Termination Agreement”) with Pfizer and agreed to terminate the
development and license agreement. The termination accelerated recognition of $45.8 million of revenue that had
been previously deferred. Under the terms of the Termination Agreement, all rights to PF582 were returned to us
in August 2016. In the third quarter of 2016, we announced top-line results from the Phase 1/2 trial, which
showed that PF582 was pharmacologically active and with a safety profile that was consistent with that of
Lucentis. We enrolled a total of 25 VEGF-inhibitor naïve patients with neovascular AMD (13 received PF582,
including one sentinel patient who received open label PF582, 12 received Lucentis). All patients received three
monthly intravitreal injections. The primary endpoint of the study was safety and tolerability of PF582 compared
to that of Lucentis. There were no clinically meaningful differences in adverse event profiles or intra-ocular
pressure between PF582 and Lucentis. The efficacy and pharmacodynamic results indicated that there were no
clinically meaningful differences in best corrected visual acuity or decreases in central retinal thickness between
PF582 and Lucentis at any of the timepoints.

In addition to our two most advanced product candidates, our pipeline includes various other biosimilar
candidates as well as vaccines and next generation biologic candidates. A few of those candidates include the
following:

Px563L – our anthrax vaccine candidate funded by BARDA. In August 2016, we announced positive
immunogenicity and safety data from Day 70 analysis of the Px563L anthrax vaccine study. The results indicated
that the vaccine was well-tolerated and afforded immunogenicity protection with fewer doses than the currently
licensed product. The randomized, double-blind, placebo-controlled Phase 1a study enrolled three cohorts in a
dose-escalating manner (10 mcg, 50 mcg and 80 mcg of antigen). Within each cohort, subjects received Px563L,
RPA563 or placebo in an 8:8:2 ratio. Subjects were administered two doses of vaccine or placebo 28 days apart.
Interim results indicated that the vaccine was well-tolerated, with the potential to afford immunogenicity
protection against anthrax infection after only two injections (vs. three for currently licensed anthrax vaccine
product). Immunogenicity was assessed by toxin-neutralizing antibody (TNA) expressed as 50% neutralizing
factor (NF50), with a threshold value ≥ 0.56 correlating with significant survival in animal models of anthrax
infection. On Day 70, 100% of Px563L subjects at the 10 mcg and 80 mcg dose levels achieved a TNA NF50
0.56, and 87.5% at the 50 mcg dose level achieved the target threshold. An additional success criterion for
assessing anthrax vaccine immunogenicity is for the lower confidence limit (LCL), or the lower bound of 95%

≥

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confidence interval, of the percentage of subjects who met or exceeded the TNA NF50 threshold of 0.56, to be
greater than or equal to 40%. On Day 70, all doses of Px563L exceeded this threshold, which was established by
the currently licensed anthrax vaccine for the indication of post-exposure prophylaxis. In addition, we have
developed a production process for the large scale manufacturing of bulk mrPA. We announced positive interim
results from a Phase 1a study in healthy subjects in the second half of 2016, and we anticipate study completion
in the first half of 2017.

PF690 – our pegaspargase (Oncaspar) biosimilar candidate. In July 2016, we entered into a license and

option agreement with Jazz, pursuant to which we and Jazz will collaboratively develop certain hematology
products, and Jazz will have the exclusive right to manufacture and commercialize such products throughout the
world. In addition, pursuant to the agreement, we have granted Jazz certain other rights to negotiate the exclusive
right to develop, manufacture and commercialize throughout the world other hematology products that are
currently or in the future may be developed by us, including PF690 (pegaspargase), a biosimilar candidate to the
reference product Oncaspar.

To date, none of our product candidates have completed clinical development, been submitted for regulatory

review or received marketing authorization from any regulatory agency, and therefore we have not received
revenue from the sale of any of our product candidates.

Our product candidates are enabled by our patented protein production platform, Pfe¯nex Expression

Technology®, which we believe confers several important competitive advantages compared to traditional
techniques for protein production, including the ability to produce complex proteins with higher accuracy and
greater degree of protein purity, as well as speed and cost advantages. The development of proteins, such as
biosimilars, requires several competencies which represent both challenges and barriers to entry. Due to their
inherent complexity, proteins require the use of living organisms to efficiently produce them at a large scale.
Traditional techniques for protein production employ a trial and error approach to production organism, or strain,
selection and process optimization, which is inherently inefficient and typically produces suboptimal results. This
historically inefficient process provides barriers to create or replicate complex proteins, adds significant time to
market and results in the high cost of goods typical of biologic therapeutics. Together, these limitations pose
significant hurdles for companies interested in entering the market with biosimilar and therapeutic equivalents to
branded products. Our platform utilizes a proprietary high throughput robotically-enabled parallel approach,
which allows the construction and testing of thousands of unique protein production variables in parallel, thereby
allowing us to produce and characterize complex proteins while reducing the time and cost of development and
long-term production.

Transparency Market Research states that the global biologics market will expand at a healthy 10.9%
compound annual growth rate from 2016 to 2024. If the number holds true, the market, which is valued at
$210 billion in 2016, is expected to rise to $480 billion by 2024. We believe the emerging biosimilar market will
be significant due to the large number of blockbuster products expected to lose patent protection in the next
several years, abbreviated regulatory pathways for the approval of biosimilars and a mandate for lower drug costs
by governments and private payers. A biosimilar is a biologic product that has been demonstrated to be highly
similar to a biologic product that is already licensed, referred to as a reference product, notwithstanding minor
differences in clinically inactive components, and where there are no clinically meaningful differences between
the reference product and the biosimilar in terms of the safety, purity, and potency of the product. By 2020,
8 biologic products representing approximately $45.6 billion of aggregate 2015 product sales are expected to lose
patent protection and become available globally for biosimilars according to IMS Health.

The market opportunities for our most advanced product candidates are substantial. Lucentis achieved

approximately $3.6 billion in global product sales in 2015. By the second quarter of 2018, markets with 2015
Lucentis sales of approximately $530 million are expected to lose patent protection, and become available to
biosimilars. Additionally, by the second quarter of 2020, markets with an additional $1.8 billion in 2015 Lucentis
sales are expected to lose patent protection and become available for biosimilars, and after January 2022 markets

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with an additional $1.2 billion in 2015 sales are expected to also lose patent protection. Approximately
$70 million in 2015 Lucentis sales come from markets for which accurate patent expiration dates are not
available. Forteo achieved product sales of approximately $1.4 billion in 2015. Almost half of these product sales
came from the US alone, followed by Japan. Forteo is expected to lose patent protection in the US, EU and Japan
in 2019.

Our revenue for the years ended December 31, 2016, 2015, and 2014 was $60.2 million, $9.6 million, and
$10.6 million, respectively. As a result of the termination of the development and license agreement with Pfizer
in August 2016, $45.8 million of revenue was recognized that had been previously deferred. Our historical
revenue has been primarily derived from monetizing our Pfe¯nex Expression Technology® through collaboration
agreements, service agreements, government contracts and reagent protein product sales, which provide for
various types of payments, including upfront payments, funding of research and development, milestone
payments, intellectual property access fees and licensing fees. Currently, various government agencies are
funding costs associated with our proprietary novel vaccine programs. As we continue to focus our business on
the development of our product pipeline, we anticipate allocating fewer resources to certain aspects of our
protein production activities that currently generate our revenue, which we expect will result in a decline of
service-related revenue associated with protein production.

As of December 31, 2016, we had an accumulated deficit of $136.0 million of which $89.8 million was

attributable to recognizing the accretion in the redemption value of our convertible preferred stock. We
recognized net income of $5.5 million for the year ended December 31, 2016 and net losses of $28.2 million and
$9.8 million for the years ended December 31, 2015 and 2014, respectively. We expect to incur substantial and
increasing losses for the next several years as we develop and advance our lead product candidates through
clinical development, expand our research and development activities, and prepare for the potential commercial
launch of our lead product candidates. As a result, our research and development expenses will increase
materially as we incur further costs of development. We currently utilize third-party clinical research
organizations, or CROs, to carry out our clinical development and we do not yet have an extensive sales
organization. We will need substantial additional funding to support our operating activities, especially as we
approach anticipated regulatory approval in the United States, Europe and other territories, and begin to establish
our commercialization capabilities. Adequate funding may not be available to us on commercially reasonable
terms, or at all. Since our inception, we have funded our operations primarily through the sale and issuance of
common stock in our public offerings, revenue from our collaboration agreements, government contracts, service
agreements, and reagent protein product sales, our prior credit facility and the private placement of equity
securities. We have devoted substantially all of our capital resources to the research and development of our
product candidates and working capital requirements. Additionally, as we continue to focus our business on the
development of our product pipeline, we anticipate allocating fewer resources to certain aspects of our protein
production activities that currently generate our revenue, which we expect will result in a decline of service-
related revenue.

Critical Accounting Policies, Significant Judgments and Use of Estimates

Our management’s discussion and analysis of financial condition and results of operations is based on our
consolidated financial statements, which have been prepared in accordance with accounting principles generally
accepted in the United States, or GAAP. The preparation of these financial statements requires us to make
estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of
contingent assets and liabilities at the date of the financial statements, as well as the reported revenue and
expenses during the reporting periods. These items are monitored and analyzed by us for changes in facts and
circumstances, and material changes in these estimates could occur in the future. We base our estimates on
historical experience and on various other factors that we believe are reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which
they become known. Actual results may differ materially from these estimates under different assumptions or
conditions. Historical results are not necessarily indicative of future results.

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We believe the following critical accounting policies involve significant judgements and estimates used in
the preparation of our consolidated financial statements (see also Note 1 to our consolidated financial statements
included in Item 8 of this Annual Report on Form 10-K).

Revenues

In accordance with GAAP, we recognize revenue when all of the following criteria are met: (1) persuasive

evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the seller’s price
to the buyer is fixed or determinable; and (4) collectibility is reasonably assured.

We consider a variety of factors in determining the appropriate method of accounting for our licensing and

collaboration agreements, including whether multiple deliverables can be separated and accounted for
individually as separate units of accounting. Where there are multiple deliverables within a collaboration
agreement that cannot be separated and therefore are combined into a single unit of accounting, revenues are
deferred and recognized over the estimated period of performance. If the deliverables can be separated, we apply
the relevant revenue recognition guidance to each individual deliverable. The specific methodology for the
recognition of the underlying revenue is determined on a case-by-case basis according to the facts and
circumstances applicable to each agreement.

Upfront, nonrefundable licensing payments are assessed to determine whether or not the licensee is able to
obtain standalone value from the license apart from the other deliverables in the arrangement. Where the license
does not have standalone value, non-refundable license fees are recorded as deferred revenue and recognized as
revenue as we perform under the applicable agreement. Where the level of effort is relatively consistent over the
performance period, we recognize fixed or determinable revenue on a straight-line basis over the estimated
period of performance. Where the license has standalone value, we recognize total license revenue at the time all
revenue recognition criteria have been met.

Nonrefundable payments for research funding are recognized as revenue over the period the underlying

research activities are performed.

Revenues under service agreements are recorded as services are performed. These agreements do not require
scientific achievement as a performance obligation and provide for payment when services are rendered. All such
revenue is nonrefundable. Upfront, nonrefundable payments for license fees, exclusivity and services received in
excess of amounts earned are classified as deferred revenue and recognized as income over the contract term or
period of performance based on the nature of the related agreement.

Revenue for our cost plus fixed fee government contracts is recognized in accordance with the authoritative
guidance for revenue recognition including the authoritative guidance specific to federal government contractors.
Reimbursable costs under our government contracts primarily include direct labor, materials, subcontracts,
accountable property and indirect costs. In addition, we receive a fixed fee under our government contracts,
which is unconditionally earned as allowable costs are incurred and is not contingent on success factors.
Reimbursable costs under our government contracts, including the fixed fee, are recognized as revenue in the
period the reimbursable costs are incurred and become billable.

We assess milestone fees on an individual basis and recognize revenue from nonrefundable milestone fees

when the earnings process is complete and the payment is reasonably assured. Nonrefundable milestone fees
related to arrangements under which we have continuing performance obligations are recognized as revenue
upon achievement of the associated milestone, provided that (i) the milestone event is substantive and its
achievability was not reasonably assured at the inception of the agreement, and (ii) the amount of the milestone
payment is reasonable in relation to the effort expended or the risk associated with the milestone event.

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Cost of Revenues

Cost of revenues includes costs incurred in connection with the execution of service contracts, government
contracts, as well as costs to manufacture or purchase, package and ship our reagent products. Cost of revenues
also includes development costs for our proprietary novel vaccine programs which are funded by various
government agencies.

Research and Development Expenses

Research and development expenses are recognized as incurred. We expect our research and development

expenses to increase for the foreseeable future as we advance our product candidates through our clinical
development programs.

Preclinical and Clinical Trial Accruals

Our clinical trial accruals are based on estimates of patient enrollment and related costs at clinical

investigator sites as well as estimates for the services received and efforts expended pursuant to contracts with
multiple research institutions and CROs that conduct and manage clinical trials on our behalf.

We estimate preclinical and clinical trial expenses based on the services performed, pursuant to contracts
with research institutions and clinical research organizations that conduct and manage preclinical studies and
clinical trials on our behalf. In accruing service fees, we estimate the time period over which services will be
performed and the level of patient enrollment and activity expended in each period. If the actual timing of the
performance of services or the level of effort varies from the estimate, we will adjust the accrual accordingly.
Payments made to third parties under these arrangements in advance of the receipt of the related series are
recorded as prepaid expenses until the services are rendered.

Stock-Based Compensation

We generally grant equity-based awards under our share-based equity incentive plans and employee stock
purchase plan. We have granted, and may in the future grant, options and restricted stock awards to employees,
directors, consultants and advisors under our 2014 and 2016 equity incentive plans and our employee stock
purchase plan (“ESPP”).

As of December 31, 2016, there were no shares available for issuance under the 2009 Plan, 0.6 million
shares available for issuance under the 2014 Plan, 0.3 million shares available for issuance under the 2016 Plan,
and 1.0 million shares available for issuance under the ESPP.

Employee stock-based compensation expense is measured at the grant date, based on the estimated fair

value of the award, and is recognized as an expense, net of estimated forfeitures, over the requisite service
period. Stock-based compensation expense is amortized on a straight-line basis over the requisite service period
for the entire award, which is the vesting period of the award.

We estimate the fair value of stock options and other equity-based compensation using a Black Scholes

option pricing model on the date of grant. The Black-Scholes valuation model requires multiple subjective
inputs. The fair value of equity instruments expected to vest are recognized and amortized on a straight line basis
over the requisite service period of the award, which is generally four years; however, certain provisions in our
equity compensation plan provide for shorter and longer vesting periods under certain circumstances.

See Note 11 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-

K for information concerning certain of the specific assumptions used in applying the Black-Scholes option
pricing model to determine the estimated fair value of employee stock options granted in 2016, 2015 and 2014.

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The Black-Scholes option pricing model requires the input of highly subjective assumptions, including the risk-
free interest rate, the expected dividend yield of our common stock, the expected volatility of the price of our
common stock, and the expected term of the option. These estimates involve inherent uncertainties and the
application of management’s judgment. If factors change and different assumptions are used, our stock-based
compensation expense could be materially different in the future.

Other Information

Income Tax Matters

We file U.S. federal income tax returns and California and Massachusetts state tax returns. We are also
subject to income tax in India. To date, we have not been audited by the Internal Revenue Service or any state tax
authority; however, tax years from and including 2012 remain open for examination by federal and state income
tax authorities. We utilize the asset and liability method of accounting for income taxes. Under this method,
deferred tax assets and liabilities are determined based on the difference between the financial statement carrying
amounts and tax basis of assets and liabilities using enacted tax rates in effect for years in which the temporary
differences are expected to reverse. A deferred income tax asset or liability is computed for the expected future
impact of differences between the financial reporting and income tax bases of assets and liabilities and for the
expected future tax benefit, if any, to be derived from tax credits and loss carryforwards. Deferred income tax
expense or benefit would represent the net change during the year in the deferred income tax asset or
liability. Deferred tax assets, if any, are reduced by a valuation allowance when, in the opinion of management, it
is more likely than not that some portion or all of the deferred tax assets will not be realized.

During the years ended December 31, 2016 and 2015, we recorded an income tax benefit of $0.2 million
and an income tax provision of $0.5 million, respectively, which is principally attributable to U.S. federal and
state income taxes. No income tax provision was recorded during the year ended December 31, 2014. Our
practice is to recognize interest and/or penalties related to income tax matters in income tax expense. We had no
accrual for interest or penalties on our consolidated balance sheets at December 31, 2016, 2015 and 2014.

As of December 31, 2016, we had federal and state research and development credits carryforwards of
approximately $2.7 million and $1.7 million, respectively, to offset potential tax liabilities. The federal research
and development credits have a 20-year carryforward period and being to expire in 2030 unless utilized.
California research and development tax credits have no expiration. We have $19.9 million federal net operating
loss carryforwards and $11.8 million of state net operating loss carryforwards as of December 31, 2016. The
federal and state net operating losses can be carried forward until 2036 unless utilized.

Pursuant to Internal Revenue Code (IRC) Sections 382 and 383, annual use of our net operating loss and
research and development credit carryforwards may be limited in the event a cumulative change in ownership of
more than 50% occurs within a three-year period. We have completed an IRC Section 382/383 analysis regarding
the limitation of net operating loss and research and development credit carryforwards and found that a greater
than 50% cumulative change in ownership occurred in August of 2014 in conjunction with our initial public
offering. We had significant built-in gains; therefore, all the pre-change net operating losses were available for
utilization.

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Results of Operations

Comparison of the years ended December 31, 2016, 2015 and 2014

The following table summarizes our net income (loss) during the periods indicated.

Years Ended December 31,

2016

2015

2014

% change from
2015 to 2016

% change from
2014 to 2015

Revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cost of revenues . . . . . . . . . . . . . . . . . . . . . . . . . .

$60,194
5,313

(in thousands)
$ 9,583
4,640

$10,644
7,233

528%
15%

Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . .

54,881

4,943

3,411

1010%

Operating expenses

Selling, general and administrative . . . . . . .
Research and development . . . . . . . . . . . . . .

17,340
32,418

14,598
18,183

9,003
4,125

Total operating expense . . . . . . . . . . . .

49,758

32,781

13,128

Income (loss) from operations . . . . . . .
Other income (expense) . . . . . . . . . . . . . . . . . . . .

Net income (loss) before income taxes . . . . . . . . .
Income tax (expense) benefit . . . . . . . . . . . . . . . .

5,123
149

5,272
209

(27,838)
74

(27,764)
(452)

(9,717)
(77)

(9,794)
—

Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . .

$ 5,481

$(28,216) $ (9,794)

19%
78%

52%

118%
101%

119%
146%

119%

(10)%
(36)%

45%

62%
341%

150%

186%
196%

183%
(100)%

188%

Revenues

Revenue increased by $50.6 million, or 528%, from $9.6 million in 2015 to $60.2 million in 2016. The
increase in revenue was primarily due to the termination of our development and license agreement with Pfizer.
As a result of the termination in August 2016, the estimated performance period was accelerated resulting in the
recognition of $45.8 million of revenue that had been previously deferred. As a result of the termination, we will
not recognize any additional future revenue under the Pfizer development and license agreement. In addition, we
recognized revenue of $4.9 million attributable to amortization of a development and license fee. We had a net
increase in revenue of $0.9 million attributable to our Px563L product candidate under our government contracts,
as the project moved into clinical trials in 2016, as well as a $0.6 million reduction in protein services revenue.
We expect revenue related to our protein production services to decline in the near-term as we shift our resources
to developing our product pipeline.

Revenue decreased by $1.0 million, or 10%, from $10.6 million in 2014 to $9.6 million in 2015. The change

in revenue was primarily due to a $2.9 million net decrease attributable to our Px563L product candidate under
our government contracts, as the development phase was completed and manufacturing activity commenced late
in 2015, as well as a $0.9 million reduction in protein services revenue, offset by $3.0 million in revenue
recognized attributed to the portion of the $51 million upfront payment under our agreement with Pfizer.

Cost of Revenues

Cost of revenue increased by $0.7 million, or 15%, to $5.3 million in 2016 compared to $4.6 million in
2015. The change was due primarily to a net increase of $0.7 million in costs for our proprietary novel vaccine
program Px563L, which is funded by a government agency. Given the nature of the novel vaccine development
process, these costs will fluctuate depending on stage of development.

Cost of revenue decreased by $2.6 million, or 36%, to $4.6 million in 2015 compared to $7.2 million in
2014. This change was due primarily to a net decrease of $2.0 million in costs for our proprietary novel vaccine
program Px563L which is funded by a government agency, as development was completed and the

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manufacturing phase began in late 2015, as well as decreased costs of $0.2 million attributable to reduced
activity related to our Px533 product candidate and a $0.1 million decrease due to reduced activity in protein
services work.

Selling, General and Administrative

Selling, general and administrative expenses increased by $2.7 million, or 19% to $17.3 million in 2016

compared to $14.6 million in 2015. The increase in selling, general and administrative was primarily due to
higher personnel-related expenses.

Selling, general and administrative expenses increased by $5.6 million, or 62% to $14.6 million in 2015
compared to $9.0 million in 2014. The increase in selling, general and administrative was primarily due to hiring
for compliance for public markets and an increase in activities associated with operating as a publicly-traded
company.

We expect general and administrative costs to continue to increase for activities associated with company

operations. These increases will likely include the hiring of additional personnel. In addition, we intend to
continue to incur increased internal and external business development costs to support our various product
development efforts, which can vary from period to period.

Research and Development

Research and development expenses increased by approximately $14.2 million, or 78%, to $32.4 million in

2016 compared to $18.2 million in 2015. The increase in research and development expenses was due to
manufacturing and development activities of PF708, which is being developed as a therapeutically equivalent
candidate Forteo, and our other biosimilar product candidates. The bioequivalence study for PF708 was
completed in 2016 and additional expenses were incurred to support upcoming clinical trials and US regulatory
submissions.

Research and development expenses increased by approximately $14.1 million, or 341%, to $18.2 million in
2015 compared to $4.1 million in 2014. The increase in research and development expenses was due primarily to
manufacturing and development activities to support upcoming clinical studies and US regulatory submissions,
as well as initiation of process development, offset by a decrease due to the Pfizer collaboration on PF582.

Our clinical trial accruals are based on estimates of patient enrollment and related costs at clinical

investigator sites as well as estimates for the services received and efforts expended pursuant to contracts with
multiple research institutions and clinical research organizations that conduct and manage clinical trials on our
behalf.

We estimate preclinical and clinical trial expenses based on the services performed, pursuant to contracts
with research institutions and clinical research organizations that conduct and manage preclinical studies and
clinical trials on its behalf. In accruing service fees, we estimate the time period over which services will be
performed and the level of patient enrollment and activity expended in each period. If the actual timing of the
performance of services or the level of effort varies from the estimate, we adjust the accrual accordingly.
Payments made to third parties under these arrangements in advance of the receipt of the related series are
recorded as prepaid expenses until the services are rendered.

We expect research and development expenses to increase as we advance our lead candidates and pipeline

product candidates. The funding necessary to bring a drug candidate to market is subject to numerous
uncertainties. Once a drug candidate is identified, the further development of that drug candidate can be halted or
abandoned at any time due to a number of factors. These factors include, but are not limited to, funding

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constraints, safety or a change in market demand. For each of our drug candidate programs, we periodically
assess the scientific progress and merits of the programs to determine if continued research and development is
economically viable. Certain of our programs may be terminated due to the lack of scientific progress and lack of
prospects for ultimate commercialization.

Liquidity and Capital Resources

The following table summarizes our cash, cash equivalents and short term investments for the periods

indicated:

December 31,

2016

2015

(in thousands)

Cash, cash equivalents and short-term

investments . . . . . . . . . . . . . . . . . . . . . . . . . . .

$81,501

$106,162

To date, we have funded our operations primarily through the sale and issuance of common stock in our
public offerings, revenue from our collaboration agreements, government contracts, service agreements, and
reagent protein product sales, our prior credit facility and the private placement of equity securities. At
December 31, 2016, we had $81.5 million in cash, cash equivalents and short-term investments compared to
$106.2 million as of December 31, 2015 and $4.0 million in restricted cash as collateral for lines of credit at
December 31, 2015. As of December 31, 2015, we had $3.8 million drawn under our prior $3.9 million Amended
Credit Facility. In February 2016, we terminated the credit facility and repaid the amount outstanding using our
restricted cash.

In July 2016, we entered into an agreement with Jazz to develop certain hematology products. Under the

terms of the collaboration, we received upfront and option payments totaling $15 million in July 2016, and may
be eligible to receive additional payments of up to $166 million based on the achievement of certain
development, regulatory, and sales-related milestones, including up to $41 million for certain non-sales-related
milestones. We may also be eligible to receive tiered royalties on worldwide sales of any products resulting from
the collaboration.

In August 2016, following Pfizer’s strategic review of the current therapeutic focus of its biosimilar
pipeline, our development and license agreement with Pfizer was terminated and all rights to PF582 were
returned to us. The termination accelerated recognition of $45.8 million of revenue that had been previously
deferred. As a result of the termination of the development and license agreement with Pfizer, management is
assessing all opportunities for the continued advancement of PF582, and we may need to obtain substantial
additional sources of funding to develop PF582 as currently contemplated. If such additional funding is not
available on favorable terms or at all, we may need to delay or reduce the scope of our PF582 development
program, or grant rights in the United States, as well as outside the United States, to PF582 to one or more
partners.

We believe that our existing cash and cash equivalents and our cash inflow from operations will be
sufficient to meet our anticipated cash needs for at least the next 12 months. We have based this estimate on
assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we
currently expect. Further, our operating plan may change, and we may need additional funds to meet operational
needs and capital requirements for product development and commercialization sooner than planned. We
currently have no credit facility or committed sources of capital although we may receive milestone and other
contingent payments under our current license and collaboration agreements. Our future capital requirements will
depend on many factors, including:

•

•

the timing and extent of spending on our research and development efforts, including with respect to
PF708 and PF582, and our other product candidates;

our ability to enter into and maintain collaboration, licensing, commercialization and other
arrangements and the terms and timing of such arrangements;

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•

•

•

•

•

•

•

•

•

•

•

the cost of manufacturing and commercialization activities, if any;

the receipt of any collaboration or milestone payments;

the scope, rate of progress, results and cost of our clinical trials, preclinical testing and other related
activities;

the emergence of competing technologies or other adverse market developments;

the time and costs involved in seeking and obtaining regulatory and marketing approvals in multiple
jurisdictions for our product candidates that successfully complete clinical trials;

the cost of preparing, filing, prosecuting, defending and enforcing any patent claims and other
intellectual property rights;

the introduction of new product candidates and the number and characteristics of product candidates
that we pursue;

the timing, receipt and amount of sales, profit sharing or royalties, if any, from our potential products;

the degree and rate of market acceptance of any products launched by us or our collaboration partners;

the expansion of our sales and marketing activities; and

the potential acquisition and in-licensing of other technologies, products or assets.

We will need to raise additional capital to fund our operations in the near future. Funding may not be
available to us on acceptable terms, or at all. If we are unable to obtain adequate financing when needed, we may
have to delay, reduce the scope of or suspend one or more of our clinical trials, research and development
programs or commercialization efforts. We may seek to raise any necessary additional capital through a
combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing
arrangements and other marketing and distribution arrangements. To the extent that we raise additional capital
through marketing and distribution arrangements or other collaborations, strategic alliances or licensing
arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future
revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable
to us. If we do raise additional capital through public or private equity offerings, the ownership interest of our
existing stockholders will be diluted, and the terms of these securities may include liquidation or other
preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing,
we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring
additional debt, making capital expenditures or declaring dividends.

Cash Flows

The following table sets forth the primary sources and uses of cash and cash equivalents for each of the

periods presented below.

Years Ended December 31,

2016

2015

2014

(in thousands)

Net cash (used in) provided by:

Operating activities . . . . . . . . . . . . . . . . . . . . . .
Investing activities . . . . . . . . . . . . . . . . . . . . . . .
Financing activities . . . . . . . . . . . . . . . . . . . . . .

$ (22,274)
(2,860)
473

$ 24,230
(1,470)
37,680

$ (10,002)
934
50,836

Net increase (decrease) in cash and cash

equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ (24,661)

$ 60,440

$ 41,768

Net cash used in operating activities was $22.3 million for the year ended December 31, 2016 compared to

net cash provided of $24.2 million for the year ended December 31, 2015. Net cash used in operating activities in

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2016 was primarily attributable to our research and development activities associated with PF708 and our other
product candidates, partially offset by $15 million of upfront and option payments received pursuant to our
license and option agreement with Jazz. In addition, our general and administrative costs increased due to higher
headcount and marketing and legal expenses. We anticipate using cash in operating activities for our research
and development efforts for the foreseeable future.

Net cash provided by operating activities was $24.2 million for the year ended December 31, 2015

compared to net cash used of $10.0 million for the year ended December 31, 2014. Cash was provided mainly by
the $51.0 million received from Pfizer in March 2015. This was offset by net losses associated with our research
and development activities. In addition, we increased our general and administrative costs as a result of activities
associated with operating as a publicly-traded company.

Net cash used in investing activities was $2.9 million for the year ended December 31, 2016 compared to
net cash used of $1.5 million for the year ended December 31, 2015. We used $2.9 million and $1.5 million in
2016 and 2015, respectively, to purchase property and equipment.

Net cash used in investing activities was $1.5 million for the year ended December 31, 2015 compared to

net cash provided of $0.9 million for the year ended December 31, 2014. We had no maturities of short-term
investments in 2015 and $1.3 million in maturities of short-term investments in 2014. We used $1.5 million and
$0.3 million in 2015 and 2014, respectively, to purchase property and equipment.

Net cash provided by financing activities was $0.5 million for the year ended December 31, 2016 compared

to net cash provided of $37.7 million for the year ended December 31, 2015. Net cash provided by financing
activities in 2016 resulted primarily from the issuance of common stock in connection with our Employee Stock
Purchase Plan and exercises of stock options and a refund of the residual restricted cash resulting from the $3.8
million repayment of the Amended Credit Facility upon termination in February 2016. Net cash provided by
financing activities in 2015 was primarily related to the net proceeds of $37.3 million from the issuance of our
common stock in connection with our follow-on offering after deducting estimated offering expenses of
approximately $0.7 million.

Net cash provided by financing activities was $37.7 million for the year ended December 31, 2015

compared to net cash provided of $50.8 million for the year ended December 31, 2014. In 2015, we received net
proceeds of approximately $37.3 million from the issuance of our common stock in connection with our follow-
on offering after deducting offering expenses. In 2014, we received net proceeds of approximately $50.6 million,
from the issuance of our common stock in connection with our IPO after deducting offering expenses. We did not
draw down on our prior revolving credit in 2015, but borrowed approximately $0.2 million in 2014. We received
$0.3 million and $0.1 million in 2015 and 2014, respectively, for the issuance of common stock in connection
with exercises of stock options.

Off-Balance Sheet Arrangements

We have not engaged in any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K,

other than a joint venture agreement, or JVA, with Strides Arcolab, and the agreements containing
indemnification provisions described below.

In March 2013, we and Strides Arcolab entered into the JVA. The JVA was established to provide a vehicle

for the advancement of certain biosimilars successful in Phase 1 trials under a joint development and license
agreement between us and Strides Arcolab. Under the terms of the JVA, both parties share equally in all
decisions, and share revenue and expenses at a rate of 51% to Strides Arcolab and 49% to us. There has been no
activity in the joint venture, or JV, to date. Once a biosimilar product successfully completes a Phase 1 trial and
Strides Arcolab and we agree to contribute the biosimilar to the JV, the JV will incur activity.

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In the normal course of business, we enter into contracts and agreements that contain a variety of
representations and warranties and provide for indemnification, including our Strides Arcolab agreements
described above. Our exposure under these agreements is unknown because it involves claims that may be made
against us in the future, but have not yet been made. As of December 31, 2016, we have not paid any claims or
been required to defend any action related to our indemnification obligations. However, we may record charges
in the future as a result of these indemnification obligations.

Contractual Obligations and Commitments

The following summarizes our contractual obligations and commitments as of December 31, 2016:

Contractual Obligations (in thousands)

Capital lease obligations . . . . . . . . . . . . . . . . . . . . . . . .
Purchase obligations . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating lease obligations . . . . . . . . . . . . . . . . . . . . . .

Payments due by period

Total

$

100
15,807
6,974

Less than 1
year

$

60
15,320
1,188

$22,881

$16,568

1 - 3 years

3 - 5 years

More than 5
years

$

26
487
1,847

$2,360

$

14
—
1,799

$1,813

$ —
—
2,140

$2,140

Purchase obligations represent agreements with contract research organizations and subcontractors to
further develop our products. These contracts can be cancelled at any time, with some having certain cancellation
fees associated with the termination of the contract, and others that only obligate us through the termination date.

In June 2010, we entered into a lease agreement (the Lease) with a landlord for an initial term of 10 years,

for our corporate headquarters comprised of one building located in San Diego, California. Occupation of the
premises under the Lease began in April 2011. Under the terms of the Lease, we pay annual base rent, subject to
an annual fixed percentage increase, plus our share of common operating expenses. The annual base rent was
subject to abatement of 50% for the first year of the lease. We recognize rent expense on a straight-line basis
over the term of the Lease. The total estimated rent payments over the life of the Lease was $3.6 million.

In September 2014, we amended the Lease to extend the term for an additional three years through June 30,
2024 and to lease additional facilities consisting of 7,315 square feet, resulting in a total increase in the estimated
rent payments over the life of the Lease by approximately $2.9 million. Base rent payments for the new space
commenced in December 2014 and increased total estimated rent payments over the life of the Lease by
approximately $1.5 million. The extended term on the existing space increased total estimated rent payments by
approximately $1.4 million. In addition to the base rent, we are obligated to pay certain customary amounts for
our share of operating expenses and tax obligations. In November 2015, we amended the Lease to add facilities
consisting of 16,811 square feet. Base rent payments for a portion of the new space commenced in March 2016,
which will increase total estimated rent payments over the life of the lease by approximately $2.3 million.

In March 2016, we entered into an operating lease for lab equipment with estimated total payments of $0.7

million over the two-year term.

Recently Issued Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or

ASU, No. 2014-09 Revenue from Contracts with Customers (Topic 606), which supersedes the revenue
recognition requirements in ASC 605, Revenue Recognition. This ASU is based on the principle that revenue is
recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to
which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional
disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer
contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to

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obtain or fulfill a contract. Numerous updates were issued in 2016 that provide clarification on a number of
specific issues as well as requiring additional disclosures. The effective date will be the first quarter of fiscal year
2019 using one of two retrospective application methods. We are in the process of determining the timing of
adoption and the adoption method. We do not expect the new standard to have a material impact on the
recognition of revenue from our reagent protein product sales. However, we continue to evaluate the impact that
this guidance will have on our consolidated financial statements in connection with the contracts with BARDA
and NIAID and our collaboration and license agreements.

In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern.

The provisions of ASU 2014-15 provide that, in connection with preparing financial statements for each annual
and interim reporting period, an entity’s management should evaluate whether there are conditions or events,
considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern
within one year after the date that the financial statements are issued. ASU 2014-15 is effective for the annual
reporting period ending after December 15, 2016, and for annual and interim periods thereafter. Early adoption is
permitted. We have adopted ASU No. 2014-15 for the year ended December 31, 2016 and the adoption did not
have a material effect on our financial statement disclosures.

In February 2016, the FASB issued ASU No. 2016-02 Leases (Topic 842), which requires lessees to
recognize “right of use” assets and liabilities for all leases with lease terms of more than 12 months. The ASU
requires additional quantitative and qualitative financial statement footnote disclosures about the leases,
significant judgments made in accounting for those leases and amounts recognized in the financial statements
about those leases. The effective date will be the first quarter of fiscal year 2020. We are currently evaluating the
impact of the adoption of this accounting standard update on our financial statements.

In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718),

Improvements to Employee Share-Based Payment Accounting. ASU 2016-09 requires, among other elements,
the excess tax benefits and deficiencies related to employee share-based payment awards and related dividends to
be recorded in the statement of operations during the reporting period in which they occur. Additionally, it allows
us to make an entity-wide accounting policy election to either estimate the number of awards that are expected to
vest (consistent with current GAAP) or account for forfeitures when they occur. ASU 2016-09 also requires that
all tax-related cash flows resulting from share-based payments, including the excess tax benefits related to the
settlement of stock-based awards, be classified as cash flows from operating activities, and that cash paid by
directly withholding shares for tax withholding purposes be classified as a financing activity in the Consolidated
Statements of Cash Flows. We have elected to early adopt ASU 2016-09 in the fourth quarter of fiscal 2016.
Amendments requiring recognition of excess tax benefits and tax deficiencies within the Consolidated
Statements of Operations were adopted prospectively and resulted in the recognition of no excess tax benefits
within income tax (benefit) expense, as any impact is offset by a change in valuation allowance. We have elected
to continue to estimate forfeitures expected to occur to determine the amount of compensation expense to be
recognized in each period. ASU 2016-09 amendments related to presentation within the Consolidated Statements
of Cash Flows were applied prospectively and resulted in no reclassification of excess tax benefits related to the
settlement of stock-based awards from financing to operating activities, and no taxes paid related to net share
settlements of stock-based compensation awards from operating activities to financing activities for the year
ended December 31, 2016.

In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash,
which clarifies the presentation of restricted cash and restricted cash equivalents in the statements of cash flows.
Under the ASU, restricted cash and restricted cash equivalents are included with cash and cash equivalents when
reconciling the beginning-of-period and end-of-period total amounts presented on the statements of cash flows.
The ASU is intended to reduce diversity in practice in the classification and presentation of changes in restricted
cash on the Consolidated Statement of Cash Flows. The ASU requires that the Consolidated Statement of Cash
Flows explain the change in total cash and equivalents and amounts generally described as restricted cash or
restricted cash equivalents when reconciling the beginning-of-period and end-of-period total amounts. The ASU

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also requires a reconciliation between the total of cash and equivalents and restricted cash presented on the
Consolidated Statement of Cash Flows and the cash and equivalents balance presented on the Consolidated
Balance Sheet. The ASU is effective retrospectively on January 1, 2018, with early adoption permitted. We do
not expect the adoption of the ASU to have a material effect on its results of operations, financial condition or
cash flows.

Segment Information

We operate in one segment. Management uses one measurement of profitability and does not segregate its

business for internal reporting. During 2016, substantially all of our long-lived assets were located within the
United States. With the exception of $0.1 million of long-lived assets held by a third-party vendor in India for
manufacturing purposes, during 2015 all of our long-lived assets were located within the United States. During
2014, all of our long-lived assets were located within the United States.

Item 7A. Quantitative and Qualitative Disclosures about Market Risk

We are exposed to market risk in the ordinary course of our business. Market risk represents the risk of loss

that may impact our financial position due to adverse changes in financial market prices and rates. Our market
risk exposure is primarily a result of fluctuations in interest rates and foreign currency exchange rates. As of
December 31, 2016, we did not hold or issue financial instruments for trading purposes.

Interest rate fluctuation risk

The primary objective of our investment activities is to preserve our capital to fund our operations. We also
seek to maximize income from our cash and cash equivalents without assuming significant risk. To achieve our
objectives, we invest our cash and cash equivalents in money market funds, treasury obligations, short term
certificates of deposit and high-grade corporate securities, directly or through managed funds, with maturities of
six months or less. As of December 31, 2016, we had cash and cash equivalents of $81.5 million consisting of
cash of $4.5 million and investments of $77.0 million in highly liquid U.S. money market funds. A portion of our
investments may be subject to interest rate risk and could fall in value if market interest rates increase. However,
because our investments are primarily short-term in duration, we believe that our exposure to interest rate risk is
not significant and a 100 basis point movement in market interest rates would not have a significant impact on
the total value of our portfolio. We actively monitor changes in interest rates.

Foreign currency exchange risk

We contract with clinical research organizations, investigational sites and suppliers in foreign countries. We

are therefore subject to fluctuations in foreign currency rates in connection with these agreements. We have not
entered into any material foreign currency hedging contracts although we may do so in the future. To date we
have not incurred any material effects from foreign currency changes on these contracts. The effect of a 10%
adverse change in exchange rates on foreign currency denominated cash and payables as of December 31, 2016
would not have been material. However, fluctuations in currency exchange rates could harm our business in the
future.

Inflation risk

Inflation may affect us by increasing our cost of labor and clinical trial costs. We do not believe that
inflation has had a material effect on our business, financial condition or results of operations for any period
presented herein.

-102-

Item 8.

Financial Statements and Supplementary Data

INDEX TO FINANCIAL STATEMENTS

Reports of Independent Registered Public Accounting Firms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Balance Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’

Equity (Deficit) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Consolidated Statements of Cash Flows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes to Consolidated Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Page(s)

104
106
107

108
109
110

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Report of Independent Registered Public Accounting Firm

The Board of Directors and Stockholders
Pfenex Inc.:

We have audited the accompanying consolidated balance sheet of Pfenex Inc. and subsidiary as of
December 31, 2016, and the related consolidated statements of operations, changes in redeemable convertible
preferred stock and stockholders’ equity (deficit), and cash flows for the year ended December 31, 2016. In
connection with our audit of the consolidated financial statements, we have also audited the financial statement
schedule II for the year ended December 31, 2016. These consolidated financial statements and financial
statement schedule are the responsibility of the Company’s management. Our responsibility is to express an
opinion on these consolidated financial statements and financial statement schedule based on our audit.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance
about whether the financial statements are free of material misstatement. An audit includes examining, on a test
basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that our audit provides a reasonable basis for our
opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects,

the financial position of Pfenex Inc. and subsidiary as of December 31, 2016, and the results of their operations
and their cash flows for the year ended December 31, 2016, in conformity with U.S. generally accepted
accounting principles. Also, in our opinion, the related financial statement schedule II for the year ended
December 31, 2016, when considered in relation to the basic consolidated financial statements taken as a whole,
presents fairly, in all material respects, the information set forth therein.

/s/ KPMG LLP

San Diego, California
March 15, 2017

-104-

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of Pfenex Inc.
San Diego, California

We have audited the accompanying consolidated balance sheet of Pfenex Inc. (the “Company”) as of
December 31, 2015, and the related consolidated statements of operations, changes in redeemable convertible
preferred stock and stockholders’ equity (deficit) and cash flows for each of the years ended December 31, 2015
and 2014. In connection with our audits of the consolidated financial statements, we have also audited the
financial statement schedule for each of the years ended December 31, 2015 and 2014. These financial
statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on
these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance
about whether the financial statements are free of material misstatement. The Company is not required to have,
nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included
consideration of internal control over financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the
Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also
includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements,
assessing the accounting principles used and significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that our audits provide a reasonable basis for our
opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects,

the consolidated financial position of Pfenex Inc. as of December 31, 2015, and the consolidated results of its
operations and its cash flows for each of the years ended December 31, 2015 and 2014 in conformity with
accounting principles generally accepted in the United States of America. Also, in our opinion, the related
financial statement schedule for each of the years ended December 31, 2015 and 2014, when considered in
relation to the basic consolidated financial statements taken as a whole, presents fairly, in all material respects,
the information set forth therein.

San Diego, California
March 10, 2016

/s/ HASKELL & WHITE LLP

HASKELL & WHITE LLP

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PFENEX INC.

Consolidated Balance Sheets

December 31,

2016

2015

(in thousands)

Assets
Current assets

Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Restricted cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts and unbilled receivables, net
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income tax receivable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 81,501
—
2,822
717
1,878

$ 106,162
3,959
2,683
508
1,718

Total current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Property and equipment, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other long term assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intangible assets, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Goodwill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

86,918
—
5,246
80
5,301
5,577

115,030
1,955
3,179
121
5,832
5,577

Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 103,122

$ 131,694

Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity
Current liabilities

Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current portion of deferred revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Line of credit obligation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income tax payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

Total current liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue, less current portion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other long-term liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1,284
9,412
6,516
—
—

17,212
5,739
26

22,977

$

886
5,997
3,870
3,813
1,676

16,242
44,225
46

60,513

Commitments and contingencies
Stockholders’ equity

Preferred stock, $0.001 par value, 10,000,000 shares authorized; no shares issued

and outstanding

Common stock, par value $0.001, 200,000,000 shares authorized at December 31,
2016 and 2015, respectively, 23,429,501 and 23,316,413 shares issued and
outstanding at December 31, 2016 and 2015, respectively . . . . . . . . . . . . . . . . . .
Additional paid-in capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated deficit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

24
216,144
(136,023)

24
212,661
(141,504)

Total stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

80,145

71,181

Total liabilities and stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 103,122

$ 131,694

The accompanying notes are an integral part of these consolidated financial statements.

-106-

PFENEX INC.

Consolidated Statements of Operations

Revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cost of revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Years Ended December 31,

2016

2015

2014

(in thousands except for per share data)
$10,644
$ 9,583
$60,194
7,233
4,640
5,313

Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

54,881

4,943

3,411

Operating expense
Selling, general and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17,340
32,418

14,598
18,183

9,003
4,125

Total operating expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

49,758

32,781

13,128

Income (loss) from operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expense), net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Net income (loss) before income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income tax benefit (expense) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5,123
149

5,272
209

(27,838)
74

(27,764)
(452)

(9,717)
(77)

(9,794)
—

Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 5,481

$(28,216) $ (9,794)

Net income (loss) per common share basic . . . . . . . . . . . . . . . . . . . . . . . . . .

Net income (loss) per common share diluted . . . . . . . . . . . . . . . . . . . . . . . . .

$

$

0.23

0.23

$

$

(1.26) $ (1.04)

(1.26) $ (1.04)

Weighted-average common shares used to compute basic net income (loss) per

share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23,389

22,376

9,441

Weighted-average common shares used to compute diluted net income (loss) per
share . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23,688

22,376

9,441

The accompanying notes are an integral part of these consolidated financial statements

-107-

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I

PFENEX INC.

Consolidated Statements of Cash Flows

Cash flows from operating activities
Net income (loss)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

activities

Years Ended December 31,

2016

2015

2014

(in thousands)

$

5,481

$ (28,216) $ (9,794)

Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amortization of intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss on disposal of property and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changes in operating assets and liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts and unbilled receivables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other current assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Notes receivable from related parties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other long term assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income tax (receivable) payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

670
531
1,955
3,156
250

(139)
(160)
—
25
431
3,250
(35,840)
(1,884)

541
531
(1,955)
1,840
59

(1,099)
58
—
(68)
(243)
3,318
47,894
1,570

465
529
—
404
—

1,877
(1,466)
95
(17)
(675)
(365)
(1,051)
(4)

Net cash provided by (used in) operating activities . . . . . . . . . . . . . . . . . . .

(22,274)

24,230

(10,002)

Cash flows from investing activities
Sales/maturities of investments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Acquisitions of property and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from sales of equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Net cash provided by (used in) investing activities . . . . . . . . . . . . . . . . . . . .

Cash flows from financing activities
Borrowings under line of credit agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repayments of borrowings under line of credit agreement
. . . . . . . . . . . . . . . . . . . . . . . . .
Restricted cash . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Repurchase of common stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from exercise of stock options and other stock issuances . . . . . . . . . . . . . . . . . . .
Proceeds from issuance of common shares from initial public offering . . . . . . . . . . . . . . . .
Proceeds from issuance of common shares from secondary offering . . . . . . . . . . . . . . . . . .

Net cash provided by financing activities . . . . . . . . . . . . . . . . . . . . . . . . . . .

—
(2,868)
8

(2,860)

—
(3,813)
3,959
—
327
—
—

473

Net increase (decrease) in cash and cash equivalents . . . . . . . . . . . . . . . . . .

(24,661)

—
(1,470)
—

(1,470)

—
—

(4)

—
342
—
37,342

37,680

60,440

1,250
(316)
—

934

223
—
74
(131)
56
50,614
—

50,836

41,768

Cash and cash equivalents
Beginning of year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

106,162

45,722

3,954

End of year

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 81,501

$106,162

$ 45,722

Supplemental schedule of cash flow information
Cash paid for interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash paid for taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-cash financing and investing transactions
Conversion of preferred stock to common stock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preferred stock dividends paid in common shares . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Beneficial dividend . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reclass from permanent to temporary equity and accretion of preferred stock redemption
value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Capital lease obligation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Purchases of property and equipment included in accounts payable and accrued

$
$

30
32

$
$

104
942

$
$

91
25

$ — $ — $113,940
7,307
$ — $ — $
1,067
$ — $ — $

$ — $ — $
$
$
$

89

42

760
130

liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

248

$ — $ —

The accompanying notes are an integral part of these consolidated financial statements

-109-

PFENEX INC.

Notes to Consolidated Financial Statements

1. Organization and Summary of Significant Accounting Policies

Business Activities and Organization

Pfenex Inc. (“Company” or “Pfenex”) was incorporated in the state of Delaware in 2009. Pfenex is a
clinical-stage biotechnology company engaged in the development of biosimilar and therapeutic equivalents to
branded therapeutics and other high-value and difficult to manufacture proteins. The Company’s lead product
candidates are PF708 and PF582. PF708 is a therapeutic equivalent candidate to Forteo (teriparatide), marketed
by Eli Lilly and Company, for the treatment of osteoporosis. A bioequivalence study for PF708 was completed in
the second quarter of 2016. The interim pharmacokinetic data from this study is expected in the second half of
2017 and the immunogenicity data is expected in the first half of 2018. PF582, a biosimilar to Lucentis
(ranibizumab), is marketed by Genentech, Inc., a wholly-owned member of the Roche Group and Novartis AG,
for the treatment of patients with retinal diseases. The Company completed a Phase 1/2 trial in patients with wet
age-related macular degeneration, or wet AMD, with Hospira, Inc. (“Hospira”), a subsidiary of Pfizer Inc.
(collectively with Hospira, “Pfizer”). Pfenex regained full rights to PF582 following Pfizer’s strategic review of
the therapeutic focus of its biosimilars pipeline. To that effect, in August 2016, the Company and Pfizer entered
into a termination agreement, pursuant to which the development and license agreement was terminated and all
rights to PF582 were returned to the Company. The termination accelerated recognition of $45.8 million of
revenue that had been previously deferred. The Company also announced top-line results from the Phase 1/2
trial, which showed that PF582 was pharmacologically active and with a safety profile that was consistent with
that of Lucentis. In addition to the Company’s two lead product candidates, its pipeline includes various other
biosimilar candidates as well as vaccines and next generation biologic candidates. The Company initiated a Phase
1a study for its recombinant anthrax vaccine at the end of 2015 and announced interim Day 70 results in the third
quarter of 2016.

The Company’s revenue in the near term is primarily related to monetizing its protein production platform
through collaboration agreements, service agreements, government contracts and reagent protein product sales
which may provide for various types of payments, including upfront payments, funding of research and
development, milestone payments, intellectual property access fees and licensing fees.

Reverse Stock Split

On June 27, 2014, the Company effected a 2.812-for-1 reverse stock split of its common and preferred
stock. All share and per share information has been retroactively adjusted to reflect this reverse stock split.

Initial Public Offering

In July 2014, the Company completed its initial public offering (“IPO”) in which 8,333,333 shares of

common stock at a price of $6.00 per share were issued and sold. Additionally, the Company sold 1,095,751
shares of common stock pursuant to the underwriters’ option to purchase additional shares. The Company
received aggregate proceeds of approximately $52.6 million from the sale of shares of common stock, net of
underwriters’ discounts and commissions, but before deducting paid and unpaid offering expenses of
approximately $2.0 million. In connection with the IPO, (i) all shares of the Company’s outstanding convertible
preferred stock automatically converted into 8,634,857 shares of common stock; (ii) the Company issued
1,217,784 shares of common stock as payment of all accrued and unpaid dividends through July 28, 2014;
(iii) the Company repurchased 423,185 shares of its common stock at a purchase price of $0.31 per share
pursuant to the amended and restated subscription agreement, dated May 2, 2014, entered into with certain
stockholders, including Signet Healthcare Partners Accredited Partnership III, LP and Signet Healthcare Partners
QP Partnership III, LP; and (iv) certain members of the Company’s executive management team forfeited an
aggregate of 100,000 shares of common stock.

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Follow-on Public Offering

In April 2015, the Company completed a follow-on public offering pursuant to which it sold 2,610,000
shares of its common stock at a price to the public of $15.50 per share. In addition, certain existing stockholders
sold 4,140,000 shares of common stock in the underwritten public offering at the same per-share price. The total
proceeds the Company received from the offering were approximately $38.0 million, net of underwriting
discounts and commissions of approximately $2.4 million. After deducting estimated offering expenses of $0.7
million, net proceeds to the Company were $37.3 million.

Subsidiary—Pfenex India Development Private Limited (“Pfenex India”)

In July 2016, to assist with the continued research and development of its pipeline products, the Company

formed a new entity in India. An application for incorporation with the Government of India Ministry of
Corporate Affairs was filed and approved for the Company’s subsidiary, Pfenex India Development Private
Limited. There has been limited activity in the subsidiary, consisting mainly of set-up costs, and all intercompany
transactions have been eliminated in the consolidated financial statements.

Pfenex India uses its local currency, the India Rupee, as its functional currency, the local currency
denominated assets and liabilities are translated at the period end exchange rates, and costs and expenses are
translated at the period end exchange rates during the periods then ended. No gain or loss resulting from foreign
currency translation is included as a component of accumulated other comprehensive income or loss because the
impact was immaterial.

Basis of Presentation

The accompanying consolidated financial statements have been prepared in accordance with United States
generally accepted accounting principles (“U.S. GAAP”), and reflect all of our activities, including those of our
wholly-owned subsidiary. All material intercompany accounts and transactions have been eliminated in
consolidation. In the opinion of management, all adjustments considered necessary for a fair presentation have
been included. These adjustments consist of normal and recurring accruals, as well as non-recurring charges.

Certain immaterial reclassifications of 2015 amounts have been made to conform with the 2016

presentation.

Segments

The Company operates in one segment. Management uses one measurement of profitability and does not
segregate its business for internal reporting. During 2016, substantially all of the Company’s long-lived assets
were located within the United States.

Use of Estimates

The preparation of the accompanying consolidated financial statements in conformity with U.S. GAAP
requires management to make estimates and assumptions that affect the reported amounts (including assets,
liabilities, revenues and expenses) and related disclosures. Estimates have been prepared on the basis of the most
current and best available information. However, actual results could differ from those estimates.

Cash and Cash Equivalents

The Company considers all highly liquid investments that are readily convertible into cash and have an

original maturity of three months or less at the time of purchase to be cash equivalents.

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Restricted Cash

As discussed in Note 6, the Company had a line of credit with Wells Fargo Bank, National Association
(“Wells Fargo”) under which the Company could borrow up to $3.9 million. The line of credit was secured by a
security interest of first priority in favor of Wells Fargo in all funds deposited into the Company’s money market
account held at Wells Fargo. In February 2016, the Company terminated the credit facility and repaid the amount
outstanding using its restricted cash.

Concentrations

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily

of cash, cash equivalents, investments and accounts and unbilled receivables. The Company has established
guidelines intended to limit its exposure to credit risk by placing investments with high credit quality financial
institutions, diversifying its investment portfolio and placing investments with maturities that help maintain
safety and liquidity. All cash and cash equivalents were held at four major financial institutions as of
December 31, 2016 and three major financial institutions as of December 31, 2015. For the Company’s cash
position of $81.5 million as of December 31, 2016, the Company has exposure to credit loss for amounts in
excess of insured limits in the event of non-performance by the institutions; however, the Company does not
anticipate non-performance.

Additional credit risk is related to the Company’s concentration of receivables. As of December 31, 2016,
receivables were concentrated among three customers representing 89% of total net receivables and one customer
as of December 31, 2015, representing 88%. The Company recognized $45.8 million in revenue upon
termination of the Pfizer agreement in August 2016. Revenue from Pfizer represented 80% of total revenue for
the year ended December 31, 2016. Two customers, including Pfizer, represented 70% of total revenue for the
year ended December 31, 2015. For the year ended December 31, 2014, revenue was concentrated among three
customers, representing 82% of total revenues. There were no supplier concentrations.

A portion of revenue is earned from sales outside the United States. Non-U.S. revenue is denominated in

U.S. dollars. A breakdown of the Company’s revenue from U.S. and non-U.S. sources for the years ended
December 31, 2016, 2015 and 2014 is as follows:

US Revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-US Revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$54,641
5,553

(in thousands)
$8,399
1,184

$ 8,782
1,862

$60,194

$9,583

$10,644

Years Ended December 31,

2016

2015

2014

For the years ended December 31, 2016 and 2015, no single foreign country accounted for more than 10%

of the Company’s revenues. For the year ended December 31, 2014, Germany accounted for 10% of the
Company’s revenues.

Risk and Uncertainties

The Company’s future results of operations involve a number of risks and uncertainties. Factors that could

affect the Company’s future operating results and cause actual results to vary materially from expectations
include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of
regulatory approval of the Company’s potential drug candidates, uncertainty of market acceptance of the
Company’s products, competition from substitute products and larger companies, securing and protecting
proprietary technology, strategic relationships and dependence on key individuals.

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Products developed by the Company require clearances from international regulatory agencies prior to
commercial sales. There can be no assurance that the products will receive the necessary clearances. If the
Company was denied clearance, clearance was delayed or the Company was unable to maintain clearance, it
could have a materially adverse impact on the Company.

As of December 31, 2016, the Company had an accumulated deficit of $136.0 million and expects to incur

substantial operating losses for the next several years. It will need to obtain additional financing in order to
complete clinical studies and launch and commercialize any product candidates for which it receives regulatory
approval. There can be no assurance that such financing will be available or will be at terms acceptable by the
Company.

Accounts and Unbilled Receivables

Accounts receivable represent primarily commercial receivables associated with the Company’s service
fees, license fees, product sales and receivables from U.S. government contracts. Accounts receivable amounted
to $1.9 million and $1.1 million as of December 31, 2016 and 2015, respectively. Unbilled receivables represent
reimbursable costs in excess of billings and, where applicable, accrued profit related to long-term government
contracts for which revenue has been recognized, but the customer has not yet been billed. Unbilled receivables
amounted to $1.0 million and $2.0 million as of December 31, 2016 and 2015, respectively.

The Company evaluates the collectability of its receivables based on a variety of factors, including the
length of time the receivables are past due, the financial health of its customers and historical experience. Based
upon the review of these factors, the Company recorded an allowance for doubtful accounts of $0.1 million and
$0.4 million at December 31, 2016 and 2015, respectively.

Fair Value of Financial Instruments

Financial instruments, including cash, cash equivalents, restricted cash and the lines of credit, are carried at

cost, which management believes approximates fair value because of the short-term maturity of these
instruments.

Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer

a liability in an orderly transaction between market participants. As such, fair value is a market-based
measurement that should be determined based on assumptions that market participants would use in pricing an
asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been
established, which prioritizes the inputs used in measuring fair value as follows:

• Level 1—Observable inputs such as quoted prices in active markets for identical assets or liabilities.
Level 1 assets at December 31, 2016 and December 31, 2015 included the Company’s cash and cash
equivalents. There were no Level 1 liabilities;

• Level 2—Inputs, other than the quoted prices in active markets, that are observable either directly or
indirectly. The Company had no Level 2 assets or liabilities at December 31, 2016 or December 31,
2015; and

• Level 3—Unobservable inputs to the valuation methodology that are significant to the measurement of
the fair value of assets or liabilities in which there is little or no market data. The Company had no
Level 3 assets or liabilities at December 31, 2016 or December 31, 2015.

Property and Equipment

Property and equipment are stated at cost and depreciated using the straight-line method over the estimated
useful lives of the assets ranging from five to ten years with the exception of leasehold improvements which are
amortized over the shorter of the lease term or their estimated useful life.

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Intangible Assets

Intangible assets include customer relationships, developed technology and trade names related to the
Company’s asset acquisition and have been capitalized and amortized over the estimated useful life of 15 years,
20 years and 15 years, respectively.

Impairment of Long-Lived Assets Other Than Goodwill

The Company assesses potential impairments to its long-lived assets whenever events or changes in
circumstances indicate that the carrying value of an asset may not be recoverable. If indicators of impairment
exist, the Company assesses the recoverability of the affected long-lived assets by determining whether the
carrying value of such assets can be recovered through undiscounted future operating cash flow expected to
result from the use of the assets. If the carrying amount is not recoverable, the Company measures the amount of
any impairment by comparing the carrying value of the asset to the present value of the expected future cash
flows associated with the use of the asset. No impairment was noted as of the years ended December 31, 2016
and 2015.

Goodwill

Goodwill is the excess of purchase price over the aggregate fair values of tangible and intangible assets
acquired, less liabilities assumed, in a business combination. The Company does not amortize goodwill. Instead,
goodwill is tested for impairment annually and between annual tests if the Company becomes aware of an event
or a change in circumstances that would indicate the carrying amount may be impaired. The Company performs
its annual impairment testing as of December 31st of each year. The Company will first assess qualitative factors
to determine whether the existence of events or circumstances suggests that it is more likely than not that
goodwill is impaired. Unless it is more likely than not that goodwill is impaired, the Company does not perform
the two-step impairment test. The Company’s determination as to whether, and, if so, the extent to which,
goodwill becomes impaired is highly judgmental and based on assumptions regarding its projected future
operating results, changes in the manner of its use of the acquired assets or its overall business strategy and
regulatory, market and economic environment and trends. No impairment was noted as of December 31, 2016
and 2015.

Revenue

The Company’s revenue is related to the monetization of its protein production platform through
collaboration agreements, service agreements, license agreements, government contracts and sales of reagent
protein products which may provide for various types of payments, including upfront payments, funding of
research and development, milestone payments, intellectual property access fees and licensing fees. The
Company’s revenue generating agreements also include potential revenues for achieving milestones and for
product royalties. The specifics of the Company’s significant agreements are detailed in Note 10—Significant
Research and Development Agreements.

The Company considers a variety of factors in determining the appropriate method of accounting for its

collaboration agreements, including whether multiple deliverables can be separated and accounted for
individually as separate units of accounting. Where there are multiple deliverables within a collaboration
agreement that cannot be separated and therefore are combined into a single unit of accounting, revenues are
deferred and recognized using the relevant guidance over the estimated period of performance. If the deliverables
can be separated, the Company applies the relevant revenue recognition guidance to each individual deliverable.
The specific methodology for the recognition of the underlying revenue is determined on a case-by-case basis
according to the facts and circumstances applicable to each agreement.

Upfront, nonrefundable licensing payments are assessed to determine whether or not the licensee is able to

obtain standalone value from the license. Where the license does not have standalone value, non-refundable

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license fees are recorded as deferred revenue and recognized as revenue as the Company performs under the
applicable agreement. Where the level of effort is relatively consistent over the performance period, the
Company recognizes fixed or determined revenue on a straight-line basis over the estimated period of
performance. Where the license has standalone value, the Company recognizes total license revenue at the time
all revenue recognition criteria have been met.

Nonrefundable payments for research funding are generally recognized as revenue over the period the

underlying research activities are performed.

Revenue under service agreements are recorded as services are performed. These agreements do not require
scientific achievement as a performance obligation and provide for payment when services are rendered. All such
revenue is nonrefundable. Upfront, nonrefundable payments for license fees, exclusivity and feasibility services
received in excess of amounts earned are classified as deferred revenue and recognized as income over the
contract term or period of performance based on the nature of the related agreement.

The Company recognizes revenue for its cost plus fixed fee government contracts in accordance with the

authoritative guidance for revenue recognition including the authoritative guidance specific to federal
government contractors. Reimbursable costs under the Company’s government contracts primarily include direct
labor, materials, subcontracts, accountable property and indirect costs. In addition, the Company receives a fixed
fee under its government contracts, which is unconditionally earned as allowable costs are incurred and is not
contingent on success factors. Reimbursable costs under the Company’s government contracts, including the
fixed fee, are generally recognized as revenue in the period the reimbursable costs are incurred and become
billable.

The Company assesses milestone payments on an individual basis and recognizes revenue from

nonrefundable milestone payments when the earnings process is complete and the payment is reasonably assured.
Nonrefundable milestone payments related to arrangements under which the Company has continuing
performance obligations are recognized as revenue upon achievement of the associated milestone, provided that
(i) the milestone event is substantive and its achievability was not reasonably assured at the inception of the
agreement, and (ii) the amount of the milestone payment is reasonable in relation to the effort expended or the
risk associated with the milestone event. The Company recognized $0.8 million in connection with the
achievement of certain milestones under a development and license agreement for the year ended December 31,
2016. For the years ended December 31, 2015 and 2014, no revenue in connection with the achievement of
milestones has been recognized.

The Company’s reagent protein products are comprised of internally developed reagent protein products and

those purchased from original manufacturers for resale. Revenues for reagent product sales are reflected net of
attributable sales tax. The Company generally offers a 30 day return policy. The Company recognizes reagent
product revenue from product sales when it is realized or realizable and earned. As of December 31, 2016, the
Company has had minimal product returns related to reagent protein product sales. No reserve for warranty and
return rights was recorded as of December 31, 2016, and reserves of $1 thousand and $10 thousand had been
recorded as of December 31, 2015 and 2014, respectively. The reserve is a component of accounts and unbilled
receivables, net in the accompanying consolidated balance sheets.

Revenue under arrangements where the Company outsources the cost of fulfillment to third parties is

evaluated as to whether the related amounts should be recorded gross or net. The Company records amounts
collected from the customer as revenue, and the amounts paid to suppliers as cost of revenue when it holds all or
substantially all of the risks and benefits related to the product or service. For transactions where the Company
does not hold all or substantially all the risk, the Company uses net reporting and therefore records the
transaction as if the end-user made a purchase from the supplier with the Company acting as a sales agent.

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Cost of Revenue

Cost of revenue includes costs incurred in connection with the execution of service contracts, as well as

costs to manufacture or purchase, package and ship the Company’s reagent products.

Preclinical and Clinical Trial Accruals

The Company’s clinical trial accruals are based on estimates of patient enrollment and related costs at

clinical investigator sites, as well as estimates for the services received and efforts expended pursuant to
contracts with multiple research institutions and clinical research organizations that conduct and manage clinical
trials on the Company’s behalf.

The Company estimates preclinical and clinical trial expenses based on the services performed, pursuant to

contracts with research institutions and clinical research organizations that conduct and manage preclinical
studies and clinical trials on its behalf. In accruing service fees, the Company estimates the time period over
which services will be performed and the level of patient enrollment and activity expended in each period. If the
actual timing of the performance of series or the level of effort varies from the estimate, the Company will adjust
the accrual accordingly. Payments made to third parties under these arrangements in advance of the receipt of the
related series are recorded as prepaid expenses until the services are rendered.

Research and Development Expenses

Research and development expenses are recognized as incurred and amounted to $32.4 million, $18.2

million and $4.1 million for the years ending December 31, 2016, 2015 and 2014, respectively.

Stock-Based Compensation

Employee stock-based compensation expense is measured at the grant date, based on the estimated fair

value of the award, and is recognized as an expense, net of estimated forfeitures, over the requisite service
period. Stock-based compensation expense is amortized on a straight-line basis over the requisite service period
for the entire award, which is generally the vesting period of the award.

The Company estimates the fair value of stock options and other equity-based compensation using a Black-

Scholes option pricing model on the date of grant. The Black-Scholes valuation model requires multiple
subjective inputs, which are discussed further in Note 11 — Stock-Based Compensation. The fair value of equity
instruments expected to vest are recognized and amortized on a straight-line basis over the requisite service
period of the award, which is generally four years; however, certain provisions in the Company’s equity
compensation plan provides for shorter and longer vesting periods under certain circumstances.

Comprehensive Loss

Comprehensive loss is defined as a change in equity of a business enterprise during a period, resulting from

transactions from non-owner sources. There have been no items qualifying as other comprehensive loss and,
therefore, for all periods presented, the Company’s comprehensive loss was the same as its reported net loss.

Income Taxes

Income taxes are accounted for under the asset-and-liability method. Deferred tax assets and liabilities are
recognized for the future tax consequences attributable to differences between the financial statement carrying
amounts of existing assets and liabilities and their respective tax bases and operating loss and tax carryforwards.
Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax

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assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment
date. The Company recognizes the effect of income tax positions only if those positions are more likely than not
of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50%
likely of being realized. Changes in recognition or measurement are reflected in the period in which the change
in judgment occurs. Valuation allowances are established, when necessary, to reduce deferred tax assets to the
amount expected to be realized. The Company accounts for interest and penalties related to income tax matters, if
any, as a component of income tax expense or benefit.

Net Income (Loss) per Share of Common Stock

Basic net income (loss) per common share is calculated by dividing the net income (loss) attributable to
common stockholders by the weighted-average number of common shares outstanding during the period, without
consideration for potentially dilutive securities. Diluted net income (loss) per share is computed by dividing net
income (loss) by the weighted-average number of common shares outstanding and potentially dilutive securities
during the period under the treasury stock method. For purposes of the diluted net income (loss) per share
calculation, stock options and employee purchase plan shares are considered to be potentially dilutive securities.
Securities are excluded from the computation of diluted net income (loss) per share if their effect would be anti-
dilutive to earnings per share. Because the Company has reported a net loss for the years ended December 31,
2015 and 2014, diluted net loss per common share is the same as basic net loss per common share for those
periods. There were no accumulated dividends related to preferred stock at December 31, 2016, 2015 or 2014.
Immediately prior to the IPO, the Company issued shares of common stock in connection with the payment of all
accrued and unpaid dividends on the preferred stock upon the conversion of the convertible preferred stock to
common stock. See Note 8—Common Stock and Preferred Stock.

Recently Issued Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update

(“ASU”) No. 2014-09 Revenue from Contracts with Customers (Topic 606), which supersedes the revenue
recognition requirements in ASC 605, Revenue Recognition. This ASU is based on the principle that revenue is
recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to
which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional
disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer
contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to
obtain or fulfill a contract. Numerous updates were issued in 2016 that provide clarification on a number of
specific issues as well as requiring additional disclosures. The effective date will be the first quarter of fiscal year
2019 using one of two retrospective application methods. The Company is in the process of determining the
timing of adoption and the adoption method. It does not expect the new standard to have a material impact on the
recognition of revenue from its reagent protein product sales. However, the Company continues to evaluate the
impact that this guidance will have on its consolidated financial statements in connection with the contracts with
BARDA and NIAID and its collaboration and license agreements.

In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements — Going
Concern. The provisions of ASU 2014-15 provide that, in connection with preparing financial statements for
each annual and interim reporting period, an entity’s management should evaluate whether there are conditions
or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going
concern within one year after the date that the financial statements are issued. ASU 2014-15 is effective for the
annual reporting period ending after December 15, 2016, and for annual and interim periods thereafter. Early
adoption is permitted. The Company has adopted ASU No. 2014-15 for the year ended December 31, 2016 and
the adoption did not have a material effect on its financial statement disclosures.

In February 2016, the FASB issued ASU No. 2016-02 Leases (Topic 842), which requires lessees to
recognize “right of use” assets and liabilities for all leases with lease terms of more than 12 months. The ASU

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requires additional quantitative and qualitative financial statement footnote disclosures about the leases,
significant judgments made in accounting for those leases and amounts recognized in the financial statements
about those leases. The effective date will be the first quarter of fiscal year 2020. The Company is currently
evaluating the impact of the adoption of this accounting standard update on its financial statements.

In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718),

Improvements to Employee Share-Based Payment Accounting. ASU 2016-09 requires, among other elements,
the excess tax benefits and deficiencies related to employee share-based payment awards and related dividends to
be recorded in the statement of operations during the reporting period in which they occur. Additionally, it allows
the Company to make an entity-wide accounting policy election to either estimate the number of awards that are
expected to vest (consistent with current GAAP) or account for forfeitures when they occur. ASU 2016-09 also
requires that all tax-related cash flows resulting from share-based payments, including the excess tax benefits
related to the settlement of stock-based awards, be classified as cash flows from operating activities, and that
cash paid by directly withholding shares for tax withholding purposes be classified as a financing activity in the
Consolidated Statements of Cash Flows. The Company has elected to early adopt ASU 2016-09 in the fourth
quarter of fiscal 2016. Amendments requiring recognition of excess tax benefits and tax deficiencies within the
Consolidated Statements of Operations were adopted prospectively and resulted in the recognition of no excess
tax benefits within income tax (benefit) expense, as any impact is offset by a change in valuation allowance. The
Company has elected to continue to estimate forfeitures expected to occur to determine the amount of
compensation expense to be recognized in each period. ASU 2016-09 amendments related to presentation within
the Consolidated Statements of Cash Flows were applied prospectively and resulted in no reclassification of
excess tax benefits related to the settlement of stock-based awards from financing to operating activities, and no
taxes paid related to net share settlements of stock-based compensation awards from operating activities to
financing activities for the year ended December 31, 2016.

In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash,
which clarifies the presentation of restricted cash and restricted cash equivalents in the statements of cash flows.
Under the ASU, restricted cash and restricted cash equivalents are included with cash and cash equivalents when
reconciling the beginning-of-period and end-of-period total amounts presented on the statements of cash flows.
The ASU is intended to reduce diversity in practice in the classification and presentation of changes in restricted
cash on the Consolidated Statement of Cash Flows. The ASU requires that the Consolidated Statement of Cash
Flows explain the change in total cash and equivalents and amounts generally described as restricted cash or
restricted cash equivalents when reconciling the beginning-of-period and end-of-period total amounts. The ASU
also requires a reconciliation between the total of cash and equivalents and restricted cash presented on the
Consolidated Statement of Cash Flows and the cash and equivalents balance presented on the Consolidated
Balance Sheet. The ASU is effective retrospectively on January 1, 2018, with early adoption permitted. The
Company does not expect the adoption of the ASU to have a material effect on its results of operations, financial
condition or cash flows.

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2. Fair Value Measurements

The fair value measurements of the Company’s cash equivalents and investments, which are measured at
fair value on a recurring basis as of December 31, 2016 and 2015, were determined using the inputs described
above and are as follows:

Fair Value Measurements at Reporting
Data Using

Quoted Prices
in Active
Markets for
Identical Assets
(Level 1)

Significant
Other
Observable
Inputs
(Level 2)

Significant
Unobservable
Inputs
(Level 3)

(in thousands)

Total

December 31, 2016

Cash and money market funds . . . . . . . . . . . $ 81,501

$ 81,501

Total assets measured at fair value . . . . $ 81,501

$ 81,501

December 31, 2015

Cash and money market funds . . . . . . . . . . . $110,121

$110,121

Total assets measured at fair value . . . . $110,121

$110,121

$

$

$

$

— $

— $

— $

— $

—

—

—

—

The Company’s policy is to recognize transfers between levels of the fair value hierarchy on the date of the

event or change in circumstances that caused the transfer. There were no significant transfers into or out of
Level 1, 2, or 3 for the years ended December 31, 2016 and 2015.

3. Property and Equipment

Property and equipment consisted of the following:

December 31,

2016

2015

Furniture and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Computers and IT equipment . . . . . . . . . . . . . . . . . . . . . . . . .
Purchased software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lab and research equipment . . . . . . . . . . . . . . . . . . . . . . . . . .
Leasehold improvements . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Construction-in-progress . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other fixed assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

$

(in thousands)
350
290
869
5,022
739
575
64

175
267
728
3,879
463
1
64

Total property and equipment, gross . . . . . . . . . . . . . . .
Less: accumulated depreciation and amortization . . . . .

7,909
(2,663)

5,577
(2,398)

Total property and equipment, net . . . . . . . . . . . . . . . . .

$ 5,246

$ 3,179

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Total property and equipment assets under capital lease were $0.2 million as of December 31, 2016 and
2015. Accumulated depreciation related to assets under capital lease as of these dates were $40 thousand and $19
thousand, respectively. For the years ended December 31, 2016, 2015 and 2014, total depreciation and
amortization expense was $0.7 million, $0.5 million, and $0.5 million each year and is included in selling,
general and administrative expenses and research and development in the accompanying consolidated statements
of operations as follows:

Selling, general and administrative . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development

Total depreciation and amortization expense . . . . . . . .

Years ended December 31,

2016

2015

2014

$ 254
416

$ 670

(in thousands)
$ 267
274

$ 541

$ 366
99

$ 465

4. Intangible Assets

Intangible assets consisted of the following:

December 31,

2016

2015

(in thousands)

Customer relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Developed technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Trade names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 3,750
4,400
910

$ 3,750
4,400
910

Gross intangible assets . . . . . . . . . . . . . . . . . . . . . . . . .
Less: Accumulated amortization . . . . . . . . . . . . . . . . . . . . . .

9,060
(3,759)

9,060
(3,228)

Total intangible assets, net

. . . . . . . . . . . . . . . . . . . . . .

$ 5,301

$ 5,832

Amortization expense related to intangible assets was $0.5 million for each of the years ended December 31,
2016, 2015 and 2014. Amortization expense is included within selling, general and administrative expense in the
accompanying consolidated statements of operations. As of December 31, 2016, estimated amortization expense
for the next five years amounts to approximately $0.5 million per year.

5. Accrued Liabilities

Accrued liabilities consisted of the following:

December 31,

2016

2015

Accrued vacation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred rent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued bonuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other accrued employee-related liabilities . . . . . . . . . . . . . .
Accrued professional fees . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued supplier liability . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accrued subcontractor costs . . . . . . . . . . . . . . . . . . . . . . . . .
Other accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

$

(in thousands)
553
627
1,385
293
266
428
4,974
886

438
380
1,239
205
447
90
2,913
285

Total accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . .

$ 9,412

$ 5,997

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6. Lines of Credit Obligation

The Company previously entered into two Revolving Line of Credit agreements with Wells Fargo
(“LOCs”), the first of which was entered into in May 2012 (“2012 LOC”) and the second in June 2013 (“2013
LOC”). The maximum capacity for the 2012 LOC and 2013 LOC was $1.5 million and $2.4 million,
respectively, for a total capacity of $3.9 million. The LOCs were collateralized by money market accounts held at
Wells Fargo. In July 2015, the Company and Wells Fargo entered into the Amended and Restated Credit
Agreement and the Amended and Restated Revolving Line of Credit Note (together, the “Amended Credit
Facility”). The Amended Credit Facility replaced the LOCs and still provided the Company with a $3.9 million
revolving line of credit which the Company could draw upon from time to time. The proceeds of the loans under
the Amended Credit Facility could be used for working capital and general corporate purposes. In February 2016,
the Company terminated the Amended Credit Facility and repaid the approximately $3.8 million outstanding
under the Amended Credit Facility using its restricted cash.

The Company recognized $8 thousand, $90 thousand and $85 thousand of interest expense related to the
Amended Credit Facility and LOCs for each of the years ended December 31, 2016, 2015 and 2014, respectively.

7. Commitments and Contingencies

Lease Agreements

In June 2010, the Company entered into an operating lease agreement (“Lease”) with a landlord for an

initial term of 10 years, for its corporate headquarters comprised of one building located in San Diego,
California. Occupation of the premises under the Lease began in April 2011. Under the terms of the Lease, the
Company pays annual base rent, subject to an annual fixed percentage increase, plus its share of common
operating expenses and tax obligations. The annual base rent was subject to abatement of 50% for the first year
of the Lease. The Company recognizes rent expense on a straight-line basis over the lease term.

In September 2014, the Company amended the Lease to extend the term for an additional three years

through March 31, 2024 and to an additional 7,315 square feet of leased space. The extended term on the existing
space increased total estimated rent payments by approximately $1.4 million. Base rent payments for the new
space commenced in December 2014 and increased total estimated rent payments over the life of the Lease by
approximately $1.5 million. In November 2015, the Company further amended the Lease to add facilities
consisting of 16,811 square feet. Base rent payments for the new space commenced in March 2016 and June
2016 and increased total estimated rent payments over the life of the Lease by approximately $2.3 million. In
January 2017, a sublease agreement was executed with a tenant to lease a portion of leased space from the
Company for eight months. The amounts received are offset against rent expense and are shown as a decrease in
commitments.

Rent expense was $0.7 million, $0.5 million, and $0.4 million for the years ended December 31, 2016, 2015

and 2014, respectively, which is included in selling, general and administrative and research and development
expenses in the accompanying consolidated statements of operations as follows:

Selling, general and administrative . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development

Total rent expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Years Ended December 31,

2016

2015

2014

(in thousands)
$290
248

$538

$279
99

$378

$375
364

$739

In addition to the Lease, the Company has entered into operating and capital lease agreements for office and

lab equipment that expire at various dates through December 2021.

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As of December 31, 2016, the total estimated future annual minimum lease payment obligations under the
Company’s non-cancelable leasing arrangements, including the facilities lease described above, are as follows:

2017 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2018 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2020 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2021 and thereafter . . . . . . . . . . . . . . . . . . . . . . . . . . .

Operating
Leases

$ 1,188
963
884
891
3,048

Total future minimum lease payments . . . . . . . .

$ 6,974

$ 100

Payment Amounts

Capital Leases

Total

(in thousands)

$

60
13
13
13
1

$ 1,248
976
897
904
3,049

$ 7,074

Clinical Study and Development Activity Commitments

The Company has entered into agreements with contract research organizations and subcontractors to
further develop our products. The total contracted costs under these arrangements totaled approximately $20.9
million as of December 31, 2016, of which $5.1 million has been incurred to date. These contracts can be
cancelled at any time, with some having certain cancellation fees associated with the termination of the contract,
and others that only obligate the Company through the termination date.

Contingencies

From time to time, the Company may be involved in legal proceedings, claims, and litigation in the ordinary

course of business. At December 31, 2016 and 2015 there were no material legal proceedings.

8. Common Stock and Preferred Stock

Common Stock

Each share of common stock is entitled to one vote. The holders of common stock are also entitled to
receive dividends whenever funds are legally available and when declared by the board of directors, subject to
the prior rights of holders of other classes of stock outstanding.

Preferred Stock

Pursuant to the amended and restated certificate of incorporation filed by the Company immediately prior to
the completion of its IPO, the board of directors is authorized to issue up to 10,000,000 shares of preferred stock
in one or more series and to fix the rights, preferences, privileges and restrictions thereof. These rights,
preferences and privileges could include dividend rights, conversion rights, voting rights, redemption rights,
liquidation preferences, and the number of shares constituting any series or the designation of such series, any or
all of which may be greater than the rights of common stock. The issuance of preferred stock could adversely
affect the voting power of holders of common stock and the likelihood that such holders will receive dividend
payments and payments upon liquidation. In addition, the issuance of preferred stock could have the effect of
delaying, deferring or preventing change in the Company’s control or other corporate action. At December 31,
2016, no preferred stock had been issued or was outstanding.

Series A-1 and A-2 Redeemable Convertible Preferred Stock

The Series A-1 and A-2 preferred stock had a contingent redemption feature allowing redemption by the
holders at any time after December 31, 2014 upon the affirmative vote of sixty-six and two thirds (66 2/3%) of the

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holders. As the event that would trigger the redemption of the redeemable convertible preferred stock was not
solely within the Company’s control, the redeemable convertible preferred stock had been classified as
mezzanine equity (outside of permanent equity) on the Company’s consolidated balance sheets. The shares were
to be redeemed by paying cash in an amount per share equal to the greater of (i) the Series A original issue price
and any Series A dividends accrued but unpaid, and (ii) the then-current fair market value of such shares.

The Company immediately recognized the changes in the redemption value as they occurred and the
carrying value of the security was adjusted to equal what the redemption amount would be as if redemption were
to occur at the end of the reporting date based on the conditions that exist as of that date. There was no limit to
the maximum amount the Company could be required to pay. A value adjustment was made to the redemption
value at June 30, 2014 as an increase of $0.8 million.

Series A-1 stock was subject to a cumulative dividend of four percent (4%) compounded quarterly, whether
or not declared. Each share of Series A-1 stock was convertible into 0.91966 shares of common stock, subject to
adjustments for certain dilutive events. Series A-2 stock was subject to a cumulative dividend of eight percent
(8%) compounded quarterly, whether or not declared. Each share of Series A-2 stock was convertible into 1.1406
shares of common stock, subject to adjustments for certain dilutive events.

Based on the IPO price of $6.00 per share and the offering closing on July 29, 2014, the Company issued

1,217,784 shares of common stock to holders of its outstanding preferred stock prior to the offering in
satisfaction of these accrued dividends through July 28, 2014. Cumulative dividends as of July 28, 2014 and
December 31, 2013 were as follows:

Series A-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Series A-1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cumulative as of July 28, 2014

Dividends

Dividends
per Share

(in thousands except dividends per share)

$4,457
2,850

$7,307

$1.25
$0.57

9. Commitment to Repurchase Stock

On December 1, 2009, the Company entered into a common stock subscription agreement with three
investors (“Investors”) pursuant to which the Company agreed to repurchase a maximum of 423,185 shares of
common stock at a price per share of $0.31. Pursuant to the amended and restated subscription agreement, dated
May 2, 2014, the Company repurchased all 423,185 shares of common stock at $0.31 price per share
immediately prior to the completion of the Company’s IPO in July 2014. The total cost of the repurchase was
$131 thousand.

10. Significant Research and Development Agreements

The Company has two types of research and development agreements (i) those for which the Company
receives funding to advance its own products (“Funding Agreements”), and (ii) those for which the Company co-
develops or assists customers in developing their products (“Collaboration Agreements”).

Funding Agreements

Strides Arcolab Limited

In December 2012, the Company and Stelis Biopharma Private Limited, a subsidiary of Strides Arcolab
Limited (“Strides”), entered into a Joint Development & License Agreement (“JDLA”), the purpose of which is

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to collaborate to develop certain therapeutic biosimilars through the completion of the first Phase 1 clinical trial.
Under the terms of the agreement, Strides is responsible for paying the costs associated with the Phase 1 trials
and the manufacturing of the drug product for the trials. Strides is obligated to reimburse the Company for any
and all payments made to third-party service providers for Phase 1 trials. As of December 31, 2012 the total of all
reimbursable costs was $0.2 million. These reimbursable costs were paid in full to Pfenex in 2013. In March
2013, the Company and Strides entered into a joint venture agreement (“JVA”). The JVA was established to
provide a vehicle for the advancement of biosimilars successful in Phase 1 trials under the JDLA. Under the
terms of the JVA, both parties share equally in all decisions, and share revenue and costs 51% to Strides and 49%
to the Company. As of December 31, 2016, there was no investment in the joint venture by the Company, and
there has been no activity in the joint venture (“JV”) to date. Once a biosimilar product successfully completes a
Phase 1 trial and Strides and the Company agree to contribute the biosimilar to the JV, the JV will incur activity.

The U.S. Department of Health and Human Services

In July 2010, the Company entered into a contract with the Biomedical Advanced Research and

Development Authority (“BARDA”) within the Office of the Assistant Secretary for Preparedness and Response
in the U.S. Department of Health and Human Services to develop a production strain and process for the
production of bulk recombinant protective antigen (“rPA”) from anthrax. The arrangement is a cost plus fixed fee
contract comprised of a base program and follow on options at BARDA’s election. At the inception of the
contract, both BARDA and the Company entered into the arrangement with the expectation that BARDA would
fund all costs of development and no costs in excess of the arrangement would be incurred by the Company. In
December 2014, the Company filed the investigational new drug (“IND”) application for Px563L. BARDA
extended the contract in December 2014 and provided additional funding, increasing the total contract to $25.2
million. The development contract was completed in August 2015.

In August 2015, the Company entered into a contract with BARDA for the advanced development of

Px563L as a novel vaccine candidate for the prevention of anthrax infection (the “BARDA Advanced
Development Agreement”). The BARDA Advanced Development Agreement is a cost plus fixed fee
development contract valued at up to approximately $143.5 million, including a 30 month base period of
performance of approximately $15.9 million, and eight option periods valued at a total of approximately $127.6
million. The 30 month base period of performance is from August 2015 through February 2018. In addition to
the base period, BARDA exercised additional phases of the development contract effective January 2017,
totaling $4.9 million and allowing for the continuing development of Px563L. The phase 2 study could initiate in
2018, provided the program continues to successfully advance with the support of BARDA. The period of
performance for the two option periods will be completed within the same base period as described above. Each
additional option period, if exercised, would extend the period of performance and the entire contract period of
performance would end in August 2020.

Revenue is recognized in accordance with the authoritative guidance for revenue recognition including the

authoritative guidance specific to federal government contractors. Reimbursable costs under this government
contract primarily include direct labor, materials, subcontracts, accountable property and indirect costs. In
addition, the Company receives a fixed fee under the BARDA contract, which is unconditionally earned as
allowable costs are incurred and is not contingent on success factors. Reimbursable costs under this BARDA
contract, including the fixed fee, are generally recognized as revenue in the period the reimbursable costs are
incurred and become billable. The Company recorded revenues of $5.0 million, $3.7 million and $6.6 million for
services performed in the years ended December 31, 2016, 2015 and 2014, respectively. Reimbursable costs
related to fulfilling on this contract amounted to $3.9 million, $2.9 million and $5.0 million for the years ended
December 31, 2016, 2015 and 2014, respectively, and are reflected in cost of revenue in the accompanying
consolidated statements of operations. The billing of any overage in indirect cost rates over the approved
provisional rates in the contract is not allowed. Any such overage is expensed as incurred. When and if final rates
with Defense Contract Audit Agency are approved, the Company will recognize any change in revenue resulting
from the rate change in the period such revised rates are approved and as such this would be considered a change

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in estimate. This agreement is subject to early termination and stop-work order in conformance with Federal
Acquisition Regulations 52.249-6 and 52.242-15 whereupon BARDA may immediately terminate the agreement
early for convenience, or request the Company to stop all or any part of the work for a period of at least 90 days.
If BARDA is not adequately funded, there is a potential that some or all of the follow on options could be
delayed or never elected.

The National Institute of Allergy and Infectious Diseases

In September 2012, the Company entered into a contract with the National Institute of Allergy and
Infectious Diseases (“NIAID”) to provide services to advance vaccine components and technologies that
accelerate the immune response for use in post-event settings following the intentional release of the NIAID
Category A Priority Pathogen Bacillus anthracis or in response to naturally occurring outbreaks of infectious
diseases caused by NIAID Category A Priority Pathogen B. anthracis. The arrangement is a cost plus fixed fee
contract comprised of a base program and 13 follow-on options at NIAID’s election. At the inception of the
contract, both NIAID and the Company entered into the arrangement with the expectation that NIAID would
fund all costs of development and no costs in excess of the arrangement would be incurred by the Company. The
total amount of the contract including options is $22.9 million, with $2.2 million eligible for payment during the
base program of approximately 14 months. The fixed fee is paid as specific activities are completed. NIAID
exercised the first option period effective in January 2015, increasing the funding to $3.0 million. NIAID
exercised the second option period effective May 2016, increasing the funding to approximately $4.1 million.
The contract has been extended through the end of December 31, 2017.

Revenue is recognized in accordance with the authoritative guidance for revenue recognition including the

authoritative guidance specific to federal government contractors. Reimbursable costs under this government
contract primarily include direct labor, subcontracts and indirect costs. In addition, the Company receives a fixed
fee under the NIAID contract, which is unconditionally earned as allowable costs are incurred and is not
contingent on success factors. Reimbursable costs under this NIAID contract, including the fixed fee, are
generally recognized as revenue in the period the reimbursable costs are incurred and become billable. The
Company recorded revenues of $0.5 million, $0.9 million and $1.0 million for services performed in the years
ended December 31, 2016, 2015 and 2014, respectively. Reimbursable costs related to fulfilling this contract
amounted to $0.4 million, $0.5 million and $0.5 million for the years ended December 31, 2016, 2015 and 2014,
respectively, and are reflected in cost of revenues in the accompanying consolidated statements of operations.
The billing of any overage in indirect cost rates over the approved provisional rates in the contract is not allowed.
Such overage is expensed as incurred. When and if final rates with Defense Contract Audit Agency are approved,
the Company will recognize any change in revenue resulting from the rate change in the period such revised rates
are approved and as such this would be considered a change in estimate. This agreement is subject to early
termination and stop-work order in conformance with Federal Acquisition Regulations 52.249-6 and 52.242-15
wherein NIAID may immediately terminate the agreement early for convenience, or request the Company to stop
all or any part of the work for a period of at least 90 days. If NIAID is not adequately funded, there is a potential
that some or all of the follow on options could be delayed or never elected.

Collaboration and License Agreements

Pfizer

In February 2015, the Company entered into a development and license agreement (“Pfizer Agreement”)
with Pfizer for the development and commercialization of PF582. Under the terms of the Pfizer Agreement, in
March of 2015 the Company received a non-refundable license payment of $51 million on receipt of antitrust
approval. Following Pfizer’s strategic review of the current therapeutic focus of its biosimilar pipeline, the
Company and Pfizer entered into a termination agreement in August 2016, pursuant to which the Pfizer

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Agreement was terminated and all rights to PF582 were returned to the Company. Upon termination, $45.8
million of previously deferred revenue was recognized. For the years ended December 31, 2016 and 2015, $48.0
and $3.0 million was recognized as license revenue related to the Pfizer Agreement, respectively.

Jazz

In July 2016, the Company entered into the Jazz Agreement for the development and commercialization of
multiple early stage hematology product candidates. The agreement also includes an option for Jazz to negotiate
a license for a recombinant pegaspargase product candidate with the Company. Under the Jazz Agreement,
Pfenex received an upfront and option payment totaling $15 million in July 2016 and may be eligible to receive
additional payments of up to $166 million based on achievement of certain research and development, regulatory
and sales related milestones, including up to approximately $41 million for certain non-sales-related
milestones. The total milestones are categorized as follows: $7 million are based on achievement of certain
research and development milestones; $34 million for certain regulatory milestones; and $125 million for sales
milestones. For the non-sales-related milestones, the Company conducted an evaluation whether they will be
recorded using the milestone method and as a result of this evaluation, estimates approximately $7.0 million of
these non-sales-related milestones are deemed to be substantive. The Company may also be eligible to receive
tiered royalties on worldwide sales of any products resulting from the collaboration. Both Jazz and the Company
will be contributing to the development efforts. Unless terminated earlier, the Jazz Agreement will continue on a
product-by-product basis for as long as Jazz is commercializing or having commercialized the products under the
Jazz Agreement.

In accordance with ASC 605-25, the Company identified all of the deliverables at the inception of the Jazz
Agreement. The significant deliverables were determined to be the research and development services related to
the pegaspargase product candidate option and for license and research and development activities of the other
hematology products. The Company has determined that the license, together with the research and development
activities, represent one unit of accounting for each product under license, as the license does not have standalone
value from the respective development activities. The research and development activities related to the
pegaspargase option were determined to have standalone value apart from the license and development activities
for the other hematology products. The estimated selling price for the Pegaspargase product candidate and the
hematology products was determined using an income approach. In determining the estimated selling price, we
considered costs expected to be incurred for internal labor, burden rates, internal margins, and subcontractors.
Based on our considerations of estimated selling price, we allocated $10 million to the Pegaspargase product
candidate and $2.5 million to each of the hematology products. The upfront and option payment is being deferred
and will be recognized as revenue ratably over the period in which the Company expects services to be rendered
for each respective unit of accounting, which approximates a range of 15 to 32 months. During the year ended
December 31, 2016, the Company recorded revenue of approximately $3.6 million related to the Jazz Agreement.

Boehringer Ingelheim International GmbH

Effective December 2010, the Company entered into a three-year transaction agreement with Boehringer
Ingelheim International GmbH (“BII”) to provide BII with access to the Company’s proprietary technology to
express BII and BII’s clients’ proteins. During the collaboration, BII had the option to obtain a commercial
license for up to four designated proteins. All collaborations and licenses under the agreement are nonexclusive.
Under the terms of the agreement, BII paid the Company an annual technology fee of $0.2 million and
guaranteed a minimum fee of $0.6 million. Additionally, for providing protein expression services, BII paid the
Company approximately $0.4 million per protein expression program with a guaranteed minimum of
$1.0 million during the term of the agreement.

The Company evaluated each of the deliverables included within the BII agreement and concluded the
underlying deliverables met the criteria to be considered separate units of accounting; therefore, the annual
technology maintenance fee was recognized in equal monthly installments over the related 12-month period, and
revenue associated with the feasibility service fees was recognized as the services were performed.

The Company recognized feasibility revenue of $1.0 million for services performed during the year ended

December 31, 2014. All performance obligations pursuant to the contract were completed during 2014. No

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deferred revenues were recorded as of December 31, 2016, 2015 or 2014, and no revenue related to the contract
was recorded during the years ended December 31, 2016 or 2015.

11. Stock-Based Compensation

Summary Stock-Based Compensation Information

The following table summarizes stock-based compensation expense:

Years Ended December 31,

2016

2015

2014

Cost of revenues . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development . . . . . . . . . . . . . . . . . . .
Selling, general and administrative . . . . . . . . . . . .

$

225
822
2,109

$

(in thousands)
124
371
1,345

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

3,156

$

1,840

$

$

49
47
308

404

Years Ended December 31,

2016

2015

2014

(in thousands)

Stock-based compensation from:

Stock options . . . . . . . . . . . . . . . . . . . . . . . . .
Employee stock purchase plan . . . . . . . . . . . .

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

$

2,983
173

3,156

$

$

1,761
79

1,840

$

$

404
—

404

Stock Option Plan

The Company’s board of directors adopted, and the Company’s stockholders approved, the Company’s
2009 Equity Incentive Plan (“2009 Plan”) in 2009. The 2009 Plan terminated in connection with the Company’s
IPO in 2014 and, accordingly, no awards will be granted under the 2009 Plan following the IPO. However, the
2009 Plan will continue to govern outstanding awards granted thereunder. An aggregate of 1.1 million shares of
common stock was reserved for issuance under the 2009 Plan. The 2009 Plan provided for the grant of incentive
stock options and for the grant of nonstatutory stock options, restricted stock, restricted stock units, and stock
appreciation rights to the Company’s employees, directors and consultants. As of December 31, 2016, awards
covering 0.5 million shares of common stock were outstanding under the 2009 Plan.

In July 2014, the board of directors adopted a 2014 Equity Incentive Plan (“2014 Plan”) and the Company’s
stockholders approved it. The 2014 Plan provides for the grant of incentive stock options, within the meaning of
Section 422 of the Internal Revenue Code, to employees and any parent and subsidiary corporations’ employees,
and for the grant of nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights,
performance units and performance shares to employees, directors and consultants and parent and subsidiary
corporations’ employees and consultants. The shares available for issuance under the 2014 Plan include shares
returned to the 2009 Plan as the result of expiration or termination of awards (provided that the maximum
number of shares that may be added to the 2014 Plan pursuant to such previously granted awards under the 2009
Plan is 961,755 shares). The number of shares available for issuance under the 2014 Plan also includes an annual
increase on the first day of each fiscal year beginning in 2015 and ending with and including the 2018 fiscal year,
equal to the least of: (i) 1,356,219 shares; (ii) 2.5% of the outstanding shares of common stock as of the last day
of the immediately preceding fiscal year; or (iii) such other amount as the board of directors may determine. As
of December 31, 2016, a total of 595,928 shares of common stock were available for issuance pursuant to the
2014 Plan. As of December 31, 2016, awards covering 1.9 million shares of common stock were outstanding
under the 2014 Plan.

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In September 2016, the board of directors adopted the 2016 Inducement Equity Incentive Plan (“2016
Plan”). The 2016 Plan provides for the grant of nonstatutory stock options, restricted stock, restricted stock units,
stock appreciation rights, performance units and performance shares to new employees. Stock options granted
under the 2016 Plan have a term of ten years from the date of grant, the exercise price for the shares to be issued
will be no less than 100% of the fair market value per share on the date of grant and generally vest over a four-
year period. The maximum aggregate number of shares that may be issued under the 2016 Plan is 500,000 shares.
As of December 31, 2016, a total of 313,710 shares of common stock were available for issuance pursuant to the
2016 Plan. As of December 31, 2016, awards covering 0.2 million shares of common stock were outstanding
under the 2016 Plan.

Stock options granted to date under the 2009 Plan and the 2014 Plan have a term of ten years from the date
of grant, and generally vest over a four-year period. However, in the event that an incentive stock option (“ISO”)
granted to a participant who, at the time the ISO is granted, owns stock representing more than ten percent
(10%) of the total combined voting power of all classes of stock of the Company, the term of the ISO shall be
five years from the grant date or such shorter term as may be provided in the award agreement.

In July 2014, the board of directors adopted the 2014 Employee Stock Purchase Plan (“ESPP”) and the
stockholders approved it. As of December 31, 2016, a total of 952,402 shares of common stock were available
for issuance under the ESPP. In addition, the ESPP provides for annual increases in the number of shares
available for sale under the ESPP on the first day of each fiscal year beginning in 2015, equal to the least of:
(i) 355,618 shares; (ii) 1.5% of the outstanding shares of the common stock on the last day of the immediately
preceding fiscal year; or (iii) such other amount as may be determined by the administrator. As of December 31,
2016, 59,037 shares have been purchased under the ESPP.

Stock Options

The exercise price of all options granted during the years ended December 31, 2016, 2015 and 2014 was
equal to the estimated fair value of the underlying common stock on the date of grant. The fair value of each
stock option granted is estimated on the grant date under the fair value method using the Black-Scholes model.
The estimated fair values of the stock option, including the effect of estimated forfeitures, are then expensed over
the requisite service period which is generally the vesting period. The following assumptions were used to
estimate the fair value of stock options:

Years Ended December 31,

2016

2015

2014

Risk-free interest rate . . . . . . . . . . . . . . . .
Expected volatility . . . . . . . . . . . . . . . . . .
Expected dividend yield . . . . . . . . . . . . . .
Expected life of options in years . . . . . . . .

1.1 – 2.0%
1.7 – 2.0%
1.3 – 1.9%
63.1 – 68.6% 49.8 – 68.2% 48.7 – 55.0%
0.0%
6.0

0.0%
5.3-6.1

0.0%
5.1-6.3

The fair value of equity instruments that are ultimately expected to vest, net of estimated forfeitures, are
recognized and amortized on a straight-line basis over the requisite service period. The Black-Scholes option-
pricing model requires multiple subjective inputs, including a measure of expected future volatility. Prior to the
Company’s IPO, the Company’s stock did not have a readily available market. Consequently, the expected future
volatility was based on the historical volatility for comparable publically traded companies over the most recent
period commensurate with the estimated expected term of the Company’s stock options. Beginning in the fourth
quarter of 2016, the expected future volatility was based on the historical volatility for the Company’s common
stock. Following the completion of the Company’s IPO in July 2014, the fair value of options granted is based on
the closing price of the Company’s common stock on the date of grant as quoted on the NYSE MKT.

The risk-free interest rate assumption is based upon observed interest rates during the period appropriate for

the expected term of the options. The expected term of the options has been estimated using the simplified

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method to determine the expected life of the Company’s options due to insufficient activity as a basis from which
to estimate future exercise patterns. With the exception of 1,217,784 shares of common stock issued in
connection with the payment of all accrued and unpaid dividends on the preferred stock immediately prior to the
completion of the Company’s IPO, the Company had never declared or paid dividends and has no plans to do so
in the foreseeable future. Accordingly, the dividend yield assumption is based on the expectation that the
Company will not pay dividends on its common stock in the future. Authoritative guidance requires forfeitures to
be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from
those estimates. The weighted-average grant date fair value of options granted during the year ended
December 31, 2016, 2015 and 2014 was $5.47, $5.91 and $4.60 respectively. Total fair value of shares vested
during the years ended December 31, 2016, 2015 and 2014 was $972 thousand, $971 thousand and $137
thousand, respectively.

Stock option transactions under the 2009, 2014 and 2016 Plans during the year ended December 31, 2016

were as follows:

Outstanding at January 1, 2016 . . .
Granted . . . . . . . . . . . . . . . . . . . . . . . .
Exercised . . . . . . . . . . . . . . . . . . . . . .
Cancelled (forfeited) . . . . . . . . . . . . . .

Outstanding at December 31,

Number of
Options
(in thousands)

Weighted
Average
Exercise Price

1,638
1,167
(78)
(156)

8.50
8.87
1.57
12.85

Weighted
Average
Remaining
Contractual
Term (in years)

Aggregate
Intrinsic Value
(in thousands)

2016 . . . . . . . . . . . . . . . . . . . . . . . .

2,571

$ 8.62

Vested and expected to vest at

December 31, 2016 . . . . . . . . . . . . .

2,346

Vested and exercisable at

December 31, 2016 . . . . . . . . . . . . .

972

$ 8.55

$ 7.53

7.96

6.67

6.67

$3,135

$3,996

$3,135

The Company received $123 thousand, $201 thousand and $56 thousand for the years ended December 31,

2016, 2015 and 2014, respectively, for options exercised. Options outstanding at December 31, 2016 have a
weighted-average remaining contractual term of 7.96 years.

As of December 31, 2016, there was approximately $6.5 million of unrecognized compensation cost related

to unvested stock option awards, and the weighted-average period over which this cost is expected to be
recognized is 2.79 years.

The total aggregate intrinsic value, which is the amount, if any, by which the exercise price was exceeded by

the estimated fair value of the Company’s common stock, of options exercised, was $0.6 million, $4.7 million
and $0.8 million for the years ended December 31, 2016, 2015 and 2014, respectively.

12. Retirement Plan

The Company has a 401(k) Savings Plan (“401(k)”). The 401(k) is for the benefit of all qualifying

employees and permits voluntary contributions by employees up to a maximum percentage allowable by current
IRS regulations. During the year ended December 31, 2016, the Company made matching contributions to the
401(k) of $197 thousand. During the years ended December 31, 2015 and 2014, the Company did not match
employee contributions.

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13. Income Taxes

The components of the income tax (benefit) expense are as follows:

Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$(2,164)
1,955

(in thousands)
$ (680)
1,132

$(1,047)
1,047

Total (benefit) expense . . . . . . . . . . . . . . . . . . . . . . . .

$ (209)

$ 452

$ —

Years Ended December 31,

2016

2015

2014

During the year ended December 31, 2016, the Company recorded an income tax benefit of $0.2 million

attributable to state income tax and the refundable Alternative Minimum Tax Credit. For the year ended
December 31, 2015, the Company recorded an income tax expense of $0.5 million attributable to U.S. federal
alternative minimum tax and state income tax. The Company’s practice is to recognize interest and/or penalties
related to income tax matters in income tax expense. The Company had no accrual for interest or penalties on the
Company’s balance sheet as of December 31, 2016 and 2015 and the Company did not recognize any interest
and/or penalties in its consolidated statements of operations during the years ended December 31, 2016, 2015, or
2014. The Company is subject to income tax in the United States, California, Massachusetts and India. The
Company currently has no years under examination by any jurisdiction; however, the Company is subject to
income tax examination by federal and various state tax authorities for the years beginning in 2012 due to federal
and state statutes.

For tax purposes, the Company recognized all of the $51 million upfront payment from Pfizer as income

during the year ended December 31, 2015. The Company also established a deferred tax asset for the difference
between the income recognized for book and tax during the year ended December 31, 2015. The contract with
Pfizer was terminated in August 2016, at which time the entire deferred tax asset of $48 million was reversed.
The reversal of the deferred revenue will provide for a carryback to the 2015 tax year, resulting in a net tax
provision for federal alternative minimum tax of $0.4 million which was recorded during the year ended
December 31, 2015.

As of December 31, 2016, the Company had federal and state research and development credits

carryforwards of approximately $2.7 million and $1.7 million, respectively, to offset potential tax liabilities. The
federal research and development credits have a 20-year carryforward period and begin to expire in 2030 unless
utilized. California research and development tax credits have no expiration. The Company has $19.9 million
federal net operating loss carryforwards and $11.8 million of state net operating loss carryforwards as of
December 31, 2016. The federal and state net operating losses can be carried forward until 2036 unless utilized.

Pursuant to Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of the Company’s net
operating loss and research and development credit carryforwards may be limited in the event that a cumulative
change in ownership of more than 50% occurs within a three-year period. The Company has completed an IRC
Section 382/383 analysis regarding the limitation of net operating loss and research and development credit
carryforwards and found that a greater than 50% cumulative change in ownership occurred in August 2014 in
conjunction with the Company’s IPO. The Company has significant built-in gains; therefore all the pre-change
net operating losses were available for utilization.

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Significant components of the Company’s deferred tax assets as of December 31, 2016 and 2015 are shown

below. A valuation allowance of $14.5 million for the year ended December 31, 2016 has been established to
offset deferred tax assets as realization of such assets is uncertain.

December 31,

2016

2015

(in thousands)

Deferred tax assets
Net operating losses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development credits . . . . . . . . . . . . . . . . . . .
Deferred revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accruals and other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 7,442
1,069
3,456
4,166
846

Total deferred tax assets . . . . . . . . . . . . . . . . . . . . . . .

16,979

$

12
535
1,225
16,506
844

19,122

Deferred tax liabilities
Depreciation and amortization . . . . . . . . . . . . . . . . . . . . . .
Intangible assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total deferred tax liabilities . . . . . . . . . . . . . . . . . . . .

(629)
(1,867)

(2,496)

(757)
(2,058)

(2,815)

Valuation allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(14,483)

(14,352)

Net deferred tax asset . . . . . . . . . . . . . . . . . . . . . . . . .

$ —

$ 1,955

A reconciliation of the Company’s effective tax rate and federal statutory tax rate at December 31, 2016,

2015 and 2014 is as follows:

Federal income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
State income taxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
State rate changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock-based compensation . . . . . . . . . . . . . . . . . . . . . . . . . .
Valuation allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and development credits . . . . . . . . . . . . . . . . . . . .
Permanent items and other . . . . . . . . . . . . . . . . . . . . . . . . . .

December 31,

2016

2015

2014

$ 1,792
190
(1,080)
489
130
(1,683)
(47)

(in thousands)
$(9,440)
(673)
743
(117)
9,984
(815)
770

$(3,330)
(567)
(2)
75
3,994
(165)
(5)

Total income tax (benefit) expense . . . . . . . . . . . . . . . . . . .

$ (209)

$

452

$ —

In accordance with authoritative guidance, the impact of an uncertain income tax position on the income tax

return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the
relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50%
likelihood of being sustained. The Company established an uncertain tax position with respect to its research and
development credits as of December 31, 2016.

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Following is a tabular reconciliation of the Company’s Unrecognized Tax Benefits activity (excluding

interest and penalties):

December 31,

2016

2015

2014

Beginning balance of unrecognized tax benefits . . . . . . . . . . . . . .
Additions based on tax positions related to the current year
. . . . .
Additions based on tax positions of prior years . . . . . . . . . . . . . . .
Reductions for tax positions of prior years . . . . . . . . . . . . . . . . . . .
Settlements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reductions due to lapse in statute of limitations . . . . . . . . . . . . . . .

(in thousands)
$ —
$301
162
369
79
139
(19) —
—
—
—
—

Reductions for tax positions of the prior year . . . . . . . . . . . . . . . . .

$730

$ 301

$ —
—
—
—
—
$ —

$ —

As of December 31, 2016, if recognized, approximately $0.7 million would affect the effective tax rate if the

Company did not have a valuation allowance.

The Company does not anticipate significant increases or decreases within the next 12 months with respect

to its unrecognized tax benefit.

14. Net Income (Loss) Per Share of Common Stock

The following table summarizes the computation of basic and diluted net income (loss) per share

attributable to common stockholders of the Company:

December 31,

2016

2015

2014

Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Weighted average shares used to compute basic net

(in thousands, except per share data)
$(28,216)

$ 5,481

$(9,794)

income (loss) per share . . . . . . . . . . . . . . . . . . . . . . . . .
Dilutive effect of employee stock option plans . . . . . . . . .

23,389
299

22,376
—

9,441
—

Dilutive weighted-average common shares

outstanding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Basic net income (loss) per common share . . . . . . . . . . . .

Diluted net income (loss) per common share . . . . . . . . . .

23,688
0.23

0.23

$

$

$

$

22,376
(1.26)

9,441
$ (1.04)

(1.26)

$ (1.04)

The following potentially dilutive securities outstanding at the end of the periods presented have been
excluded from the computation of diluted shares outstanding because of their anti-dilutive impact to earnings per
share:

Options to purchase common stock . . . . . . . . . . . . . . . . . . . . . . . .
ESPP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1,774
60

(in thousands)
1,638
33

1,232
45

December 31,

2016

2015

2014

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15. Quarterly Financial Data (unaudited)

The following is a summary of the quarterly results of the Company for the years ended December 31, 2016

and 2015:

First
Quarter

Second
Quarter
(in thousands, except for per share data)

Fourth
Quarter

Third
Quarter

Year Ended
December 31

2016
Revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cost of revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 2,764
1,276

$ 3,135
1,440

$48,824
1,285

$ 5,471
1,312

$ 60,194
5,313

Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income, net . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income tax benefit (expense) . . . . . . . . . . . . . . . . . . . . .

1,488
9,696
—

(1)

1,695
11,907
46
—

47,539
13,095
52
—

4,159
15,060
51
210

Net income (loss) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8,209)

(10,166)

34,496

(10,640)

54,881
49,758
149
209

5,481

Net income (loss) per share:

Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ (0.35) $
$ (0.35) $

(0.43) $
(0.43) $

1.47
1.46

$
$

(0.45)
(0.45)

$
$

0.23
0.23

Shares used in the calculation of net income (loss) per

share:

Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23,353
23,353

23,379
23,379

23,400
23,689

23,424
23,424

23,389
23,688

2015
Revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cost of revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 1,975
1,308

$ 2,290
921

$ 2,057
682

$ 3,261
1,729

$ 9,583
4,640

Gross profit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expense), net . . . . . . . . . . . . . . . . . . . . . .
Income tax expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

667
6,700
80
(19)

1,369
7,298
(33)
(21)

1,375
8,955
(9)
(1)

1,532
9,828
36
(411)

4,943
32,781
74
(452)

Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5,972)

(5,983)

(7,590)

(8,671)

(28,216)

Net loss per share:
Basic and Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Shares used in the calculation of net loss per share:
Basic and Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ (0.29) $

(0.27) $ (0.33) $

(0.37)

$

(1.26)

20,474

22,460

23,215

23,295

22,376

Item 9.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

None.

Item 9A. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Interim Chief Executive Officer and our Chief Financial
Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period
covered by this Annual Report on Form 10-K. The term “disclosure controls and procedures,” as defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
means controls and other procedures of a company that are designed to ensure that information required to be
disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed,
summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and

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procedures include, without limitation, controls and procedures designed to ensure that information required to
be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and
communicated to management, including its principal executive and principal financial officers, or persons
performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Management recognizes that any controls and procedures, no matter how well designed and operated, can
provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment
in evaluating the cost-benefit relationship of possible controls and procedures. Based upon that evaluation, the
Interim Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and
procedures were not effective as of December 31, 2016, due to the material weakness in internal control over
financial reporting that is described below. Notwithstanding the material weakness in our internal control over
financial reporting as of December 31, 2016, management has concluded that the consolidated financial
statements included in this Form 10-K present fairly, in all material respects, our financial position, results of
operations and cash flows for the periods presented.

Management’s Annual Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial

reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act). Management conducted an
assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in
Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (2013 framework). Based on this assessment, management has concluded that its internal control
over financial reporting was ineffective as of December 31, 2016 due to the existence of a material weakness.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial

reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim
financial statements will not be prevented or detected on a timely basis. We did not maintain an effective control
environment as our former Chief Executive Officer failed to set an appropriate “Tone at the Top.” Specifically,
our former Chief Executive Officer failed to act in accordance with our Board Approval Process Policy and Code
of Ethics and Conduct as a result of his failure to comply with certain board approval procedures for third-party
contracts. This control deficiency did not result in a misstatement to our consolidated financial statements.
However, this control deficiency could have resulted in a material misstatement to our annual or interim
consolidated financial statements that would not be prevented or detected. Accordingly, our management has
determined that this control deficiency constitutes a material weakness.

Our independent registered public accounting firm, KPMG LLP, is not required to and has not issued an

attestation report as of December 31, 2016 due to a transition period established by the rules of the SEC for
newly public companies that have not lost their “emerging growth company” status as defined in the JOBS Act.

Remediation Plan and Activities

Management, with the participation and input of the audit committee and the board of directors, is engaged

in remedial activities to address the material weakness described above. The remedial activities include the
following:

• A change in our Chief Executive Officer when our board appointed a new Interim Chief Executive

Officer, President, and Secretary following the resignation of our former Chief Executive Officer on
January 23, 2017;

• Requiring documentation of approvals for contracts that implicate the Board Approval Process Policy;

•

Increasing the frequency of our internal audit testwork to assess the design, implementation, and
operating effectiveness of our entity level and process level controls; and

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•

Increasing communication with, and training of employees regarding:

• Our commitment to ethical standards and the integrity of our business practices;

• Requirements for compliance with our Board Approval Process Policy and Code of Ethics and

Conduct, including training of new hires and re-training of existing employees; and

• Availability of and processes for reporting suspected violations of our Code of Ethics and

Conduct.

We are committed to maintaining a strong internal control environment, and we believe we are making
progress toward achieving the effectiveness of our internal controls and disclosure controls. The actions that we
are taking are subject to ongoing senior management review, as well as audit committee oversight. We will not
be able to conclude whether the steps we are taking will fully remediate this material weakness in our internal
control over financial reporting until we have completed our remediation efforts and subsequent evaluation of
their effectiveness. We may also conclude that additional measures may be required to remediate the material
weakness in our internal control over financial reporting, which may necessitate additional implementation and
evaluation time. We will continue to assess the effectiveness of our internal control over financial reporting and
take steps to remediate the known material weakness expeditiously.

Changes in Internal Control Over Financial Reporting

During the three months ended December 31, 2016, we identified a material weakness in our internal
control over financial reporting because our former Chief Executive Officer failed to set an appropriate “Tone at
the Top.” As described above under “Remediation Plan and Activities,” we have been taking steps to remediate
the material weakness identified above.

Inherent Limitations on Effectiveness of Controls

Management recognizes that a control system, no matter how well designed and operated, can provide only

reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a
control system must reflect the fact that there are resource constraints and that management is required to apply
its judgment in evaluating the benefits of possible controls and procedures relative to their costs. Because of the
inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all
control issues and instances of fraud or error, if any, have been detected. These inherent limitations include the
realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple
error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion
of two or more people, or by management override of the controls. The design of any system of controls also is
based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that
any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may
become inadequate because of changes in conditions, or the degree of compliance with policies or procedures
may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error
or fraud may occur and not be detected.

Item 9B. Other Information

Not applicable.

-135-

PART III

Item 10. Directors, Executive Officers and Corporate Governance

The information required by this item is incorporated herein by reference from our definitive proxy
statement relating to our 2017 annual meeting of shareholders. The definitive proxy statement will be filed with
the Securities and Exchange Commission within 120 days after the end of the 2016 fiscal year.

Codes of Ethics and Conduct

Our board of directors has adopted a code of business conduct and ethics that applies to all of our
employees, officers, and directors, including our Chief Executive Officer, Chief Financial Officer, and other
executive and senior financial officers. The full text of our Code of Ethics and Conduct is posted on the Investors
portion of our website at http://pfenex.investorroom.com/. We will post amendments to our Code of Ethics and
Conduct or waivers of our Code of Ethics and Conduct for directors and executive officers on the same website.

Item 11. Executive Compensation

The information required by this item is incorporated herein by reference from our definitive proxy
statement relating to our 2017 annual meeting of shareholders. The definitive proxy statement will be filed with
the Securities and Exchange Commission within 120 days after the end of the 2016 fiscal year.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder

Matters

The information required by this item is incorporated herein by reference from our definitive proxy
statement relating to our 2017 annual meeting of shareholders. The definitive proxy statement will be filed with
the Securities and Exchange Commission within 120 days after the end of the 2016 fiscal year.

Item 13. Certain Relationships and Related Transactions and Director Independence

The information required by this item is incorporated herein by reference from our definitive proxy
statement relating to our 2017 annual meeting of shareholders. The definitive proxy statement will be filed with
the Securities and Exchange Commission within 120 days after the end of the 2016 fiscal year.

Item 14. Principal Accounting Fees and Services

The information required by this item is incorporated herein by reference from our definitive proxy
statement relating to our 2017 annual meeting of shareholders. The definitive proxy statement will be filed with
the Securities and Exchange Commission within 120 days after the end of the 2016 fiscal year.

-136-

PART IV

Item 15. Exhibits and Financial Statement Schedules

(a) The following documents are filed as part of this report:

1. Financial Statements

See Index to Financial Statements at Item 8 herein.

2. Financial Statement Schedules

SCHEDULE II—VALUATION AND QUALIFYING ACCOUNTS

Years Ended December 31,

2016

2015

2014

(in thousands)

Allowance for Doubtful Accounts:

Beginning balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Charged to costs and expenses . . . . . . . . . . . . . . . . . . . . . . . .
Reductions and write-offs . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 408
—
(358)

$ 585
0
(177)

$ 44
559
(18)

Ending balance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 50

$ 408

$585

All other schedules have been omitted because they are not required, not applicable, or the required

information is otherwise included.

3. Exhibits

The documents listed in the Exhibit Index of this Annual Report on Form 10-K are incorporated by

reference or are filed with this report, in each case as indicated therein (numbered in accordance with Item 601 of
Regulation S-K).

-137-

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant
has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly
authorized.

Date: March 15, 2017

Pfenex Inc.

By: /s/ Patrick K. Lucy
Patrick K. Lucy
Interim Chief Executive Officer, President, and
Secretary, and Chief Business Officer

POWER OF ATTORNEY

Each person whose signature appears below constitutes and appoints Patrick K. Lucy and Paul A. Wagner,

and each of them, as his or her true and lawful attorney-in-fact and agent, with full power of substitution
and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any
and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other
documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-
in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing
requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might
or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them,
or their or his substitutes, may lawfully do or cause to be done by virtue thereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by

the following persons on behalf of the registrant and in the capacities and on the dates indicated:

Signature

Title

Date

/s/ Patrick K. Lucy

Patrick K. Lucy

/s/ Paul A. Wagner

/s/ Patricia Lady

Paul A. Wagner

Patricia Lady

Interim Chief Executive Officer,
President, and Secretary, and
Chief Business Officer

(Principal Executive Officer)

Chief Financial Officer
(Principal Financial Officer)

Chief Accounting Officer
(Principal Accounting Officer)

March 15, 2017

March 15, 2017

March 15, 2017

/s/ William R. Rohn

Chairman and Director

March 15, 2017

William R. Rohn

/s/ Robin D. Campbell

Robin D. Campbell

/s/ Dennis Fenton

Dennis Fenton

/s/ Phillip M. Schneider

Phillip M. Schneider

/s/ John Taylor

John Taylor

Director

Director

Director

Director

March 15, 2017

March 15, 2017

March 15, 2017

March 15, 2017

-138-

Exhibit
Number

3.1

3.2

4.1

4.2

4.3

10.1+

10.2+

10.3+

10.4+

10.5

10.6

10.7

10.8

10.9

10.10†

EXHIBIT INDEX

Description

Form

File No.

Exhibit

Filing Date

Incorporated by Reference

Amended and Restated Certificate of
Incorporation of the Registrant.

Amended and Restated Bylaws of the
Registrant.

Specimen Stock Certificate.

Investors’ Rights Agreement, dated
December 1, 2009, as amended, by and
among the Registrant and the investors
named therein.

Amended and Restated Subscription
Agreement, dated May 2, 2014.

2009 Equity Incentive Plan and form of
award thereunder.

2014 Equity Incentive Plan and form of
award thereunder.

8-K

001-36540

3.2

July 29, 2014

S-1

333-196539

3.3

June 5, 2014

S-1/A 333-196539

S-1/A 333-196539

4.1

4.2

June 23, 2014

July 7, 2014

S-1

333-196539

4.3

June 5, 2014

S-1

333-196539

10.1

June 5, 2014

S-1/A 333-196539

10.2

July 17, 2014

2014 Employee Stock Purchase Plan.

S-1/A 333-196539

10.3

July 7, 2014

10-Q 001-36540

10.4

November 9, 2016

S-1

S-1

333-196539

10.4

June 5, 2014

333-196539

10.5

June 5, 2014

8-K

001-36540

10.1

September 25, 2014

10-K 001-36540

10.7

March 10, 2016

10-Q 001-36540

10.2

May 9, 2016

S-1/A 333-196539

10.6

June 25, 2014

2016 Inducement Equity Incentive Plan and
forms of award thereunder.

Form of Indemnification Agreement.

Lease Agreement, dated June 22, 2010,
between the Registrant and BRS-Tustin
Safeguard Associates II, LLC.

First Amendment to Multi-Tenant Industrial/
Commercial Lease dated September 4, 2014
between the Registrant and BRS-Tustin
Safeguard Associates II, LLC.

Second Amendment to Multi-Tenant
Industrial/Commercial Lease dated
November 19, 2015 between the Registrant
and BRS-Tustin Safeguard Associates II,
LLC.

Third Amendment to Multi-Tenant
Industrial/Commercial Lease dated February
24, 2016 between the Registrant and BRS-
Tustin Safeguard Associates II, LLC.

Joint Development & License Agreement,
dated December 31, 2012, between the
Registrant and Agila Biotech Private
Limited.

-139-

Exhibit
Number

10.11†

10.12†

10.13

10.14

10.15

10.16†

10.17†

10.18†

10.19

10.20

10.21

Description

Form

File No.

Exhibit

Filing Date

Incorporated by Reference

S-1/A 333-196539

10.7

June 25, 2014

S-1/A 333-196539

10.8

June 25, 2014

S-1

333-196539

10.9

June 5, 2014

S-1

333-196539

10.10

June 5, 2014

S-1

333-196539

10.11

June 5, 2014

S-1/A 333-196539

10.12

June 25, 2014

10-Q 001-36540

10.4

November 14, 2014

10-K 001-36540

10.15 March 16, 2015

10-Q 001-36540

10.6

May 14, 2015

10-Q 001-36540

10.1

August 13, 2015

10-Q 001-36540

10.2

November 13, 2015

Joint Venture Agreement, dated March 7,
2013, between the Registrant and Agila
Biotech Private Limited.

Technology License Agreement, dated
November 30, 2009, between the Registrant
and The Dow Chemical Company.

Grant Back License Agreement, dated
November 30, 2009, between the Registrant
and The Dow Chemical Company.

Technology Assignment Agreement, dated
November 30, 2009, between the Registrant
and The Dow Chemical Company.

Contribution Assignment and Assumption
Agreement, dated November 30, 2009,
between the Registrant and The Dow
Chemical Company.

Subcontract Agreement, effective
September 11, 2009, between the Registrant,
as assignee of The Dow Chemical Company,
and Science Applications International
Corporation.

Subcontract Agreement, Modification 21,
effective September 12, 2014, between the
Registrant, as assignee of The Dow Chemical
Company, and Science Applications
International Corporation.

Cost Plus Fixed Fee Agreement, dated
July 30, 2010, as amended December 18,
2014, between the Registrant and the United
States Department of Health and Human
Services.

Modification No. 11, effective January 5,
2015, to Contract Agreement dated July 30,
2010, between the Registrant and the United
States Department of Health and Human
Services

Modification No. 12, effective May 5, 2015,
to Contract Agreement dated July 30, 2010,
between the Registrant and the United States
Department of Health and Human Services.

Modification No. 13, effective July 23, 2015,
to Contract Agreement dated July 30, 2010,
between the Registrant and the United States
Department of Health and Human Services.

-140-

Exhibit
Number

10.22†

10.23†

10.24

10.25

10.26

10.27

10.28

10.29

10.30

10.31

10.32

10.33

Description

Form

File No.

Exhibit

Filing Date

Incorporated by Reference

Modification No. 14, effective October 20,
2015, to Contract Agreement dated July 30,
2010, between the Registrant and the United
States Department of Health and Human
Services.

Modification No. 15, effective March 14,
2016, to Contract Agreement dated July 30,
2010, between the Registrant and the United
States Department of Health and Human
Services.

Credit Agreement, dated May 1, 2012, as
amended, between the Registrant and Wells
Fargo Bank, National Association.

Third Amendment to Credit Agreement,
dated December 11, 2014, between the
Registrant and Wells Fargo Bank, National
Association.

Amended and Restated Credit Agreement,
dated July 1, 2015, between the Registrant
and Wells Fargo Bank, National Association.

First Amendment to Amended and Restated
Credit Agreement, dated September 28,
2015, between the Registrant and the Wells
Fargo Bank, National Association.

Security Agreement, dated May 1, 2012,
between the Registrant and Wells Fargo
Bank, National Association.

Security Agreement, dated June 24, 2013,
between the Registrant and Wells Fargo
Bank, National Association.

Security Agreement dated June 24, 2014
between the Registrant and Wells Fargo
Bank, National Association.

Revolving Line of Credit Note, dated May 1,
2012, between the Registrant and Wells
Fargo Bank, National Association.

Revolving Line of Credit Note, dated June
24, 2013, between the Registrant and Wells
Fargo Bank, National Association.

Amended and Restated Revolving Line of
Credit Note, dated July 1, 2015, between the
Registrant and Wells Fargo Bank, National
Association.

-141-

10-K 001-36540

10.20 March 10, 2016

10-Q 001-36540

10.4

May 9, 2016

S-1

333-203418

10.16 April 15, 2015

10-K 001-36540

10.17 March 16, 2015

8-K

001-36540

10.1

July 6, 2015

10-Q 001-36540

10.3

November 13, 2015

S-1

333-196539

10.15

June 5, 2014

S-1

333-196539

10.17

June 5, 2014

S-1/A 333-196539

10.28

July 7, 2014

S-1

333-203418

10.19 April 15, 2015

S-1

333-203418

10.21 April 15, 2015

8-K

001-36540

10.2

July 6, 2015

Exhibit
Number

10.34

10.35+

10.36+

10.37+

10.38+

10.39+

10.40+

10.41+

10.42+

10.43+

Description

Form

File No.

Exhibit

Filing Date

Incorporated by Reference

Securities Account Control Agreement,
dated June 24, 2013, between the Registrant
and Wells Fargo Bank, National Association.

Executive Employment Agreement, dated
June 20, 2014, between the Registrant and
Bertrand C. Liang.

Executive Employment Agreement, dated
June 20, 2014, between the Registrant and
Paul A. Wagner.

Executive Employment Agreement, dated
June 20, 2014, between the Registrant and
Patricia Lady.

Executive Employment Agreement, dated
June 20, 2014, between the Registrant and
Patrick K. Lucy.

Executive Employment Agreement, dated
June 20, 2014, between the Registrant and
Henry W. Talbot.

Executive Employment Agreement, dated
November 3, 2014, between the Registrant
and Hubert C. Chen.

Executive Employment Agreement, dated
September 26, 2016, between the Registrant
and Steven Sandoval, Sr.

Separation Agreement and Release by and
between the Company and Bertrand C. Liang
effective January 23, 2017.

Consulting Agreement by and between the
Company and Bertrand C. Liang effective
January 23, 2017.

S-1

333-196539

10.19

June 5, 2014

S-1/A 333-196539

10.20

June 23, 2014

S-1/A 333-196539

10.21

June 23, 2014

S-1/A 333-196539

10.22

June 23, 2014

S-1/A 333-196539

10.23

June 23, 2014

S-1/A 333-196539

10.24

June 23, 2014

10-K 001-36540

10.29 March 16, 2015

10-Q 001-36540

10.3

November 9, 2016

8-K

001-36540

10.1

January 24, 2017

8-K

001-36540

10.2

January 24, 2017

10.44+

Executive Incentive Compensation Plan.

S-1/A 333-196539

10.27

June 23, 2014

10.45†

10.46

10.47†

Contract Agreement, dated September 27,
2012, between the Registrant and the
National Institutes of Health.

Modification No. 3, dated October 31, 2014,
to Contract Agreement, dated September 27,
2012, between the Registrant and the
National Institutes of Health.

Modification No. 4, dated January 5, 2015, to
Contract Agreement, dated September 27,
2012, between the Registrant and the
National Institutes of Health.

-142-

S-1/A 333-196539

10.25

June 25, 2014

10-K 001-36540

10.32 March 16, 2015

10-K 001-36540

10.33 March 16, 2015

Exhibit
Number

10.48†

10.49†

10.50†

10.51†

10.52†

Description

Form

File No.

Exhibit

Filing Date

Incorporated by Reference

Modification No. 5, dated April 5, 2015, to
Contract Agreement, dated September 27,
2012, between the Registrant and the
National Institutes of Health.

Modification No. 6, dated November 2,
2015, to Contract Agreement, dated
September 27, 2012, between the Registrant
and the National Institutes of Health.

Modification No. 7, dated February 22, 2016,
to Contract Agreement, dated September 27,
2012, between the Registrant and the
National Institutes of Health.

Modification No. 8, dated May 16, 2016, to
Contract Agreement, dated September 27,
2012, between the Registrant and the
National Institutes of Health.

Modification No. 9, effective September 28,
2016, to Contract Agreement, dated
September 27, 2012, between the Registrant
and the National Institutes of Health.

S-1

333-203418

10.34 April 15, 2015

10-K 001-36540

10.43 March 10, 2016

10-Q 001-36540

10.3

May 9, 2016

10-Q 001-36540

10.1

August 8, 2016

10-Q 001-36540

10.2

November 9, 2016

10.53#* Modification No. 10, effective October 31,

10.54†

10.55†

10.56†

10.57†

2016, to Contract Agreement, dated
September 27, 2012, between the Registrant
and the National Institutes of Health.

Development and License Agreement, dated
February 9, 2015, between the Registrant and
Hospira Bahamas Biologics Ltd.

S-1/A 333-203418

10.35 April 23, 2015

Cost Plus Fixed Fee Agreement, dated
August 14, 2015 between the Registrant and
the United States Department of Health and
Human Services.

10-
Q/A

001-36540

10.1

February 23, 2016

Modification No. 1, effective October 15,
2015, to Cost Plus Fixed Fee Agreement,
dated August 14, 2015, between the
Registrant and the United States Department
of Health and Human Services.

Modification No. 2, effective February 17,
2016, to Cost Plus Fixed Fee Agreement,
dated August 14, 2015, between the
Registrant and the United States Department
of Health and Human Services.

10-K 001-36540

10.46 March 10, 2016

10-Q 001-36540

10.1

May 9, 2016

-143-

Exhibit
Number

Description

Form

File No.

Exhibit

Filing Date

Incorporated by Reference

10-Q 001-36540

10.1

November 9, 2016

10.58#* Modification No. 3, effective November 29,

2016, to Cost Plus Fixed Fee Agreement,
dated August 14, 2015, between the
Registrant and the United States Department
of Health and Human Services.

10.59#* Modification No. 4, effective January 9,
2017, to Cost Plus Fixed Fee Agreement,
dated August 14, 2015, between the
Registrant and the United States Department
of Health and Human Services.

10.60†

License and Option Agreement, dated July
27, 2016, by and between the Registrant and
Jazz Pharmaceuticals Ireland Limited.

23.1*

23.2*

24.1*

31.1*

31.2*

32.1^

Consent of KPMG LLP, Independent
Registered Public Accounting Firm.

Consent of Haskell & White, LLP,
Independent Registered Public Accounting
Firm.

Power of Attorney (contained on signature
page).

Certification of Chief Executive Officer
pursuant to Exchange Act Rules 13a-14(a)
and 15d-14(a), as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of
2002.

Certification of Chief Financial Officer
pursuant to Exchange Act Rules 13a-14(a)
and 15d-14(a), as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of
2002.

Certifications of Chief Executive Officer and
Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002.

101.INS*

XBRL Instance Document.

101.SCH* XBRL Taxonomy Extension Schema

Document.

101.CAL* XBRL Taxonomy Extension Calculation

Linkbase Document.

101.DEF* XBRL Taxonomy Extension Definition

Linkbase Document

-144-

Exhibit
Number

Description

Form

File No.

Exhibit

Filing Date

Incorporated by Reference

101.LAB* XBRL Taxonomy Extension Label Linkbase

Document

101.PRE* XBRL Taxonomy Extension Presentation

Linkbase Document

*
^

†

#

+

Filed herewith.
The information in this exhibit is furnished and deemed not filed with the Securities and Exchange
Commission for purposes of section 18 of the Exchange Act of 1934, as amended (the “Exchange Act”), and
is not to be incorporated by reference into any filing of Pfenex Inc. under the Securities Act of 1933, as
amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof,
regardless of any general incorporation language in such filing.
Portions of the exhibit have been omitted pursuant to an order granted by the Securities and Exchange
Commission for confidential treatment.
Portions of this exhibit have been omitted pursuant to a request for confidential treatment and the non-public
information has been filed separately with the SEC.
Indicates a management contract or compensatory plan.

-145-

BOARD OF DIRECTORS

CORPORATE HEADQUARTERS

William R. Rohn
Chairman
Former Chief Operating Officer of Biogen Idec

Robin D. Campbell
Technology Management Program Lecturer at
University of California, Santa Barbara

the

Phillip M. Schneider
Former Senior Vice President and Chief Financial
Officer at IDEC Pharmaceuticals Corporation

Dennis M. Fenton
Former Executive Vice President at Amgen, Inc.

John M. Taylor
President and Principal of Compliance and Regulatory
Affairs at Greenleaf Health LLC

Pfenex Inc.
10790 Roselle St.
San Diego, CA 92121
T: (858) 352-4400
F: (858) 352-4602
www.pfenex.com

COMMON STOCK LISTING

NYSE MKT
Ticker Symbol: PFNX

ANNUAL MEETING OF STOCKHOLDERS

May 5, 2017 at 12:00 p.m. Pacific Time
Offices of Wilson Sonsini Goodrich & Rosati, P.C.
12235 El Camino Real, Suite 200
San Diego, CA 92130

CORPORATE EXECUTIVES

REGISTRAR AND TRANSFER AGENT

Patrick K. Lucy
Interim Chief Executive Officer, President, and Secretary,
and Chief Business Officer

For questions regarding your account, changes of
address or the consolidation of accounts, please
contact the Company’s transfer agent:

Paul A. Wagner
Chief Financial Officer

Patricia Lady
Chief Accounting Officer

Hubert C. Chen
Chief Medical Officer

Steven S. Sandoval Sr.
Chief Manufacturing Officer

American Stock Transfer & Trust Company, LLC
6201 15th Avenue
Brooklyn, NY 11219
T: 800-937-5449
www.amstock.com

LEGAL COUNSEL

Wilson Sonsini Goodrich & Rosati,
Professional Corporation
San Diego, California

INDEPENDENT AUDITORS

KPMG LLP
San Diego, California

INVESTOR RELATIONS

Pfenex Inc.
Investor Relations
10790 Roselle St.
San Diego, CA 92121
Telephone: (858) 352-4400
E: investors@pfenex.com