Changing the shape of life science research
and transforming medical care.
A N N U A L R E P O R T 2 0 1 6
Company Profile
Organovo designs and creates functional human tissues using its proprietary 3D bioprinting
technology. With reproducible 3D tissues that accurately represent human biology, Organovo is
enabling ground-breaking therapies. 3D human tissues have the potential to accelerate the drug
discovery process, enabling treatments to be developed faster and at lower cost.
Organovo partners with biopharmaceutical companies and academic medical centers to build and
validate more predictive in vitro tissues for toxicology and disease modeling. By giving researchers
a solution they have never had before – the opportunity to evaluate drugs on functional human
tissue before ever administering the drug to a living human being – Organovo is bridging the gap
between preclinical testing and clinical trials.
Organovo conducts early research on specific tissues for therapeutic use to repair or replace
damaged or diseased tissues.
Who is Organovo?
• We participate in attractive and growing markets with critical unmet needs.
• We benefit from favorable competitive dynamics and a first mover advantage.
• We’re a technology leader with a strong IP portfolio.
• We’re leveraging our technology platform to build a robust product and service portfolio.
across the preclinical safety, efficacy and disease modeling and therapeutic tissues markets.
FY2016 Operating Highlights
• Generated fiscal-year 2016 total revenue of $1.5 million, a 160% year-over-year increase.
• Closed a $43 million public offering to support R&D and the development and
commercialization of products.
• Partnered with L’Oreal USA to develop 3D bioprinted skin tissue.
• Achieved functional validation of our 3D bioprinted kidney tissue.
• Samsara, our wholly-owned subsidiary, which is focused on the provision of high-quality
primary human liver cells for in vivo and in vitro research applications, launched
commercial operations.
Financial Highlights
(in millions) 2014 2015 2016
Organovo Holdings, Inc.
Revenue $0.4 $0.6 $1.5
Product and Service – $0.3 $0.8
Collaborations $0.2 $0.1 $0.5
Grants $0.1 $0.1 $0.2
Net Loss ($25.8) ($30.1) ($38.6)
Cash and Cash Equivalents $48.2 $50.1 $62.1
* Fiscal year ending March 31
Mission
We strive to enable superior patient outcomes by
delivering functional human tissue products that
revolutionize drug discovery and transplant medicine.
%
8
R : 9
G
A
w t h C
e G r o
Revenue Growth
(dollars in millions)
u
n
e
v
e
6 R
1
0
4 - 2
1
0
2
■ Grants
■ Collaborations
■ Product and Service
2014 2015 2016
1.5
1.0
0.5
0.0
We design and create functional human tissues using our proprietary three-dimensional bioprinting technology.
O rg a n ovo H o l d i n g s, I n c. 1
Dear Fellow Shareholders:
Keith Murphy,
Chairman and Chief Executive Officer
A long-term plan with near-term inflection points
It’s been a true pleasure leading Organovo over the past year. Though
there has been some churn in the broader market around us, our internal
progress and trajectory have never felt stronger. During the past year, we
recorded a solid pace of revenue growth in the first full year of our new
commercial business, we hit a tremendous milestone in the demonstration
of fibrosis in liver tissues, and we moved along key projects such as our
kidney tissue and animal studies of therapeutic transplant tissues. I’d like
to recap some of what makes Organovo great today and tell you about
what to expect from us in the future.
When I think about what excites me most about Organovo, it’s our
team and our technology, which form the needed core of our ability to
deliver for shareholders. As the team has grown in recent years, we’ve
focused on building not just a group of people, but a great culture. We’ve
successfully developed a strong culture, which has been behind many of our scientific and commercial
achievements. Our team is engaged, motivated, and unified. We are working together to drive wins for patients,
partners and shareholders, and we are having fun doing it. Our partners and customers see it and share their
feedback with us, validating that we’re building a strong and effective team. To be sure that this culture
perpetuates, we’ve taken time this past year to capture it in writing. You’ll find the results inside this annual
report and I know you’ll agree we’re on the right track.
The power of our technology platform is at the core of what keeps this amazing team of people engaged
year after year. In some ways, we’re still in the early chapters, but the consistently impressive results across
tissue types suggest that a truly great book is being written. We’re forging new ground by marrying engineering
and biology to do what no one else has ever done before. We’re designing and producing 100% cellular native
human tissue that recreates the key aspects of in vivo form and function. To a great degree, our 3D bioprinted
tissues match the biological function of tissues in the human body. Our extremely powerful scientific results
bode well for future opportunities.
Looking out over the next few years, we’ll continue to work to achieve scientific milestones and we anticipate
commercial success. Four key pillars guide
our long-term plan. First, we participate in
attractive and growing markets with critical
unmet needs. When you consider the
development costs and timelines for
pharmaceutical discovery, which are typically
about a decade and roughly $1 billion for a
single drug, it’s clear that pharma customers
need better, more predictive solutions. In the
past 25 years, many drugs have failed in
human clinical trials or have been withdrawn
from the market altogether, the majority of
which were due to toxicity or lack of efficacy.
We believe we can significantly impact the
cost, predictability and speed of drug
discovery with our solutions. Similarly, with
Bridging the gaps in pharmaceutical discovery by giving researchers
something they’ve never had before – the opportunity to test drugs for
safety and efficacy before ever giving the drug to a human.
2 2016 Annual Repor t
the constant supply challenges that exist in transplant medicine, we have
the long-term potential to transform therapeutic applications by creating
tissue replacement products for surgical implantation. Second, we benefit
from a first mover advantage. This is a dynamic space that is changing
rapidly with many organizations working on interesting solutions, but no
one really does what we do. Third, we’re a technology leader with a world-
class IP portfolio. Our team really does a great job making engineering
enhancements to our bioprinting process and extending the influence
and reach of our innovation. Our IP portfolio now includes more than 25
exclusive patents globally and more than 110 patent applications pending.
Finally, the power and versatility of our technology platform allows us to
build out our product and service portfolio and target multiple revenue
streams. There is tremendous leverage in our business model driving the
breadth and diversity of our long-term revenue profile in the preclinical
safety, disease and efficacy modeling and therapeutic tissues markets.
A year of innovation and progress
In fiscal 2016, we dealt head on with the challenges of commercial
traction to assure that the end result was a rewarding year that allowed
Technology leadership with a world-class IP
portfolio that includes more than 25 exclusive
patents globally.
“We’re forging new
ground by marrying
engineering and biology
to do what no one else
has ever done before.”
us to chart an excellent path
forward. We grew total revenue to $1.5 million, a 160% year-over-year
increase, with the primary contributions coming from our exVive3DTM
Liver research services and collaboration agreements. This was our
first full year of commercial results and we learned a great deal.
We’re pleased with our early customer profile in the liver business,
as we’ve attracted healthcare customers from across the spectrum.
We’ve won business from five of the Top 25 global pharmaceutical
companies, and have also had good traction with smaller enterprises
and private venture-backed companies. Importantly, we’ve seen repeat contracts from a high percentage of our
customers, which supports the applicability of our liver tissue in preclinical research and the quality of our work.
One important lesson, which will be critical to driving customer penetration in all of our business lines, is that you
can never have enough scientific data. We’ve had customer posters,
third-party research institutions and internal validation studies highlighting
our science, but we intend to do more. It’s all about credibility with our
customers, and we continue to invest in developing additional proof sets.
It also takes time to build customer relationships. We are offering
high-content solutions that have the potential to change the way
pharmaceutical companies do business. It’s a new paradigm and
they’re receiving insights from us on their drug development and
discovery efforts that they’ve never had before. Just as we’re creating
a new market, they’re figuring out how to integrate our products and
services into their preclinical workflow. We all want to go faster,
and by building out our sales and marketing footprint in the last
several months, we’ve taken an important step in that direction.
As you can see from our guidance, we have growing confidence
in our ability to achieve in these markets.
With our partnerships and research collaborations, we’ve struck
significant deals that extend our reach beyond primarily transactional
services to multiple potential revenue streams that could include royalty
and licensing opportunities. Our partnership with L’Oreal USA, a leader
in the beauty and cosmetics space, is a great example. Our agreement
We collaborate with leading academic
institutions and industry partners, combining
our expertise to develop transplantable tissues.
O rg a n ovo H o l d i n g s, I n c. 3
with them contemplates being their commercial supplier for certain
bioprinted skin tissue products, co-marketing these products to other
beauty and cosmetics companies, and a royalty opportunity on their
new products that are tested in our 3D skin model. Similarly, our deal
with Merck has multiple components including a toxicology piece and
developing custom tissues for disease modeling. In both cases, we’ve
completed the early phases of our agreements and they’ve begun to
meaningfully contribute to our top line.
We also launched Samsara Sciences this year, our wholly-owned
subsidiary, whose core mission is the provision of high-quality primary human
liver cells for a wide variety of in vivo and in vitro research applications.
“The power and versatility
of our technology platform
allows us to build out our
product and services
portfolio and target
multiple revenue streams.”
Samsara will contribute
to our consolidated
revenue through
agreements it has
with other commercial
buyers, but its real
value to Organovo lies
on the cash flow side of the ledger. Cellular raw materials are a
critical input for our products and services, and this step allows
us to materially improve our supply chain and reduce expenses.
The high-precision, advanced instrumentation
of our bioprinter allows us to produce tissues
that closely mimic native architecture.
What’s the next chapter for Organovo?
Perhaps the most exciting reason to be your CEO these days are the scientific and operating milestones that lie
ahead. While the long-term outlook for Organovo is powerful, we anticipate great progress this year, and expect
you to be impressed in the short-term as well. There are several important catalysts in fiscal 2017. We expect
to meaningfully grow customer penetration and revenue in our liver business. Our kidney development timeline
remains on track for initiation of commercial contracting in the calendar third quarter of 2016. This product will
expand our portfolio in the preclinical safety market, and we’re seeing solid customer interest through our early
access program. In the therapeutic tissues business, we’re achieving solid results in animal models on the
multiple tissue types we’re evaluating and are narrowing down the candidates we anticipate moving forward.
We plan to share some high-level data and our next steps in the
coming months, and we expect this will be exciting for investors.
As for our liquidity position and balance sheet profile, when you take
our fiscal 2016 year-end cash balance and our forecasted cash needs
in fiscal 2017, we have approximately two years of cash on hand to
execute our current business plan. We’ll continue to be thoughtful in
deploying our resources to balance growth and operating efficiency.
I am proud to be the CEO of an innovative and visionary company.
I thank my colleagues at Organovo for their loyalty, dedication and hard
work, and am grateful for the continued support of our stockholders,
customers and partners during the course of the year. I look forward
to strong execution in fiscal 2017 and am excited that the best is still
ahead of us.
Our scientists work with customers to
tailor the framework of their preclinical
testing programs.
4 2016 Annual Repor t
Keith Murphy
Chairman and Chief Executive Officer
June 2016
Safe Harbor Statement
Any statements contained in this Annual Report that do not describe historical facts are forward-looking
statements as defined under the Federal securities laws. The Company has based these forward-looking
statements on its current expectations and the information currently available to it, but any forward-
looking statements are subject to a number of risks and uncertainties. The factors that could cause the
Company’s actual future results to differ materially from its current expectations, or from the results
implied by any forward-looking statements, include, but are not limited to, risks and uncertainties
relating to the Company’s ability to develop, market and sell products and services based on its
technology; the expected benefits and efficacy of the Company’s products, services and technology; the
market acceptance of the Company’s products and services; the Company’s ability to generate revenue
and control its operating losses; the validity of the Company’s intellectual property rights and the ability
to protect those rights; and the Company's ability to implement and achieve its business, research,
product development, regulatory approval, marketing and distribution plans and strategies. These and
other factors are identified and described in more detail in the Company’s filings with the Securities and
Exchange Commission (“the SEC”), including those factors listed under the caption "Risk Factors" in the
Company’s Annual Report on Form 10-K for the year ended March 31, 2016, filed with the SEC on June
9, 2016, as well as other filings Organovo makes with the SEC from time to time. Readers are cautioned
not to place undue reliance on forward-looking statements, which speak only as of the date of this
Annual Report. Except as required by applicable law, the Company does not intend to update any of the
forward-looking statements to conform these statements to reflect actual results, later events or
circumstances or to reflect the occurrence of unanticipated events.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(Mark One)
(cid:95) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended March 31, 2016
OR
(cid:133) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Transition Period from to
Commission File No. 001-35996
ORGANOVO HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State of incorporation)
6275 Nancy Ridge Drive, Suite 110
San Diego, CA
(Address of principal executive offices)
Title of Each Class
Common Stock, par value $0.001
per share
Registrant’s telephone number, including area code: 858-224-1000
Securities registered pursuant to Section 12(b) of the Act:
27-1488943
(IRS Employer Identification No.)
92121
(Zip code)
Name of Each Exchange on which
Registered
NYSE MKT
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 (cid:133) No (cid:95)
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes (cid:133) No (cid:95)
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 (cid:95) No (cid:133)
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 during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes (cid:95) No (cid:133)
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K 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. (cid:95)
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company
(as defined in Rule 12b-2 of the Exchange Act).
Large accelerated filer (cid:133)
Non-accelerated filer
(cid:133)
Accelerated filer
(cid:95)
Smaller reporting company (cid:133)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes (cid:133) No (cid:95)
The aggregate market value of the voting common stock held by non-affiliates based on the closing stock price as reported on the NYSE MKT on
September 30, 2015, the last trading day of the registrant’s second fiscal quarter, was $227,966,466. For purposes of this computation only, all
executive officers, directors and 10% or greater stockholders have been deemed affiliates.
The number of outstanding shares of the registrant’s common stock, as of June 1, 2016 was 92,391,989.
Documents Incorporated by Reference
Certain information required for Part III of this report is incorporated herein by reference to the proxy statement for the 2016 annual meeting of the
registrant’s stockholders, expected to be filed within 120 days of the end of the registrant’s fiscal year.
Organovo Holdings, Inc.
Annual Report on Form 10-K
For the Year Ended March 31, 2016
Table of Contents
Important Information Regarding Forward-Looking Statements
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PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
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Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Selected Financial Data
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Consolidated Financial Statements
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
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PART III
Item 10. Directors, Executive Officers and Corporate Governance
Item 11.
Item 12.
Item 13.
Item 14.
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accountant Fees and Services
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PART IV
Item 15.
Exhibits and Financial Statement Schedules
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38
Important Information Regarding Forward-Looking Statements
Portions of this Annual Report on Form 10-K (including information incorporated by reference) include “forward-looking statements”
based on our current beliefs, expectations and projections regarding our technology, our product development opportunities and
timelines, our business strategies, the market potential of our technology and products, our future capital requirements, our future
financial performance and other matters. This includes, in particular, “Item 1 — Business” and “Item 7 — Management’s Discussion
and Analysis of Financial Condition and Results of Operations” of this Annual Report on Form 10-K as well as other portions of this
Annual Report on Form 10-K. The words “believe,” “expect,” “anticipate,” “project,” “could,” “would,” and similar expressions,
among others, generally identify “forward-looking statements”, which speak only as of the date the statements were made. The
matters discussed in these forward-looking statements are subject to risks, uncertainties and other factors that could cause our actual
results to differ materially from those projected, anticipated or implied in the forward-looking statements. As a result, you should not
place undue reliance on any forward-looking statements. The most significant of these risks, uncertainties and other factors are
described in “Item 1A — Risk Factors” of this Annual Report on Form 10-K. Except to the limited extent required by applicable law,
we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events
or otherwise.
1
Item 1. Business.
Overview
PART I
Organovo Holdings, Inc. (“Organovo Holdings,” “we,” “us,” “our,” “the Company” and “our Company”) is an early commercial stage
company focused on developing and commercializing functional human tissues that can be employed in drug discovery and
development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. We
intend to introduce a paradigm shift in the approach to the generation of three-dimensional (“3D”) human tissues, by utilizing our
proprietary platform technology to create human tissue constructs in 3D that mimic native human tissue composition, architecture, and
function. We believe we will leverage our highly unique 3D human tissue models to improve the current industry standard cell-based
and animal model testing approaches to drug discovery and development by creating 3D tissues constructed solely of human cells. We
believe our foundational approach to the 3D printing of living tissues, as disclosed in peer-reviewed scientific publications, and the
continuous evolution of our core bioengineering technology platform combine to provide us with the opportunity to fill many critical
gaps in commercially available preclinical human tissue modeling and tissue transplantation.
Our foundational proprietary technology, grounded in over a decade of peer-reviewed scientific publications, derives from research
led by Dr. Gabor Forgacs, the George H. Vineyard Professor of Biological Physics at the University of Missouri-Columbia. We have a
broad portfolio of intellectual property rights covering the principles, enabling instrumentation, applications, and methods of cell-
based printing, including exclusive licenses to certain patented and patent pending technologies from the University of Missouri-
Columbia and Clemson University. We have continued to develop our technology and grow our intellectual property portfolio. In
addition to our in-licensed patents, we own outright more than 90 additional patents and pending patent applications around the world.
We believe that our broad and exclusive commercial rights to patented and patent-pending 3D bioprinting technology, 3D tissues and
applications provides us with a strong and defensible market position for the successful commercialization of 3D bioprinted human
tissues serving a broad array of unmet preclinical and clinical needs.
We believe we have the potential to build and maintain a sustainable business by leveraging our core technology platform across a
variety of applications. We have entered into multiple collaborative research agreements with pharmaceutical corporations and
academic medical centers. We have also secured federal grants, including Small Business Innovation Research grants, to support the
development of our technology. We developed the NovoGen MMX Bioprinter™ (our first-generation 3D bioprinter) less than two
years after commencing operations, and the Bioprinter was named one of the “Best Inventions of 2010” by TIME Magazine, and won
a number of engineering innovation awards. Our first tissue product, exVive3D™ Liver, Bioprinted Human Tissue, was launched in
2014 and received the CONNECT Most Innovative Product award for 2014 in Life Sciences (Diagnostics & Research Tools). The
exVive3D Liver was also selected as one of the Top 10 Innovations of 2014 by The Scientist magazine. We were selected by MIT’s
Technology Review magazine among the Most Innovative Companies of 2012, by Inc. Magazine as one of the Most Audacious
Companies in 2013, by Fast Company as one of the most innovative companies in healthcare for 2015, and as a Technology Pioneer
for 2015 by the World Economic Forum in Davos, Switzerland. We believe these corporate achievements provide strong validation
for the commercial potential of our 3D bioprinting platform and the tissues it produces.
Our Platform Technology
Our platform technology is centered on multiple 3D bioprinting technologies, which we have utilized to develop our proprietary
instrument platform, our NovoGen Bioprinters®. Our 3D bioprinting technologies enable a wide array of tissue compositions and
architectures to be created, using purely cellular ‘bio-ink’ (building blocks comprised of only living cells), biocompatible hydrogels,
or combinations of the two. A key distinguishing feature of our bioprinting platform is the ability to generate complex 3D tissues that
have all or some of their components comprised entirely of cells. Prior to the invention of our NovoGen bioprinting platform, the most
common fabrication method for 3D tissues was the use of biomaterial scaffolding into which cells were incorporated. While useful for
some applications, scaffold-based engineered tissues lack features of native tissue that are critical to function such as dense cellularity
wherein cells have intimate contact with neighboring cells, and an intricate architecture created by the spatial arrangement of specific
cellular compartments relative to each other. Organovo’s 3D bioprinting platform can deliver tissues that are truly three-dimensional
with a cellularity and architecture that closely resembles native tissue. Moreover, most tissues can be generated using human cells as
inputs, yielding functional models of human tissue that can be used in vitro for drug discovery and development. In the future,
complex bioprinted human tissues may also address unmet clinical needs by serving as tissue grafts for the augmentation or
replacement of functional mass in tissues and organs that have sustained significant damage by trauma or disease.
2
We are focused on developing the following products:
•
•
•
A suite of standardized, 3D human tissues for the preclinical assessment of drug effects, including applications in
predictive toxicology, absorption, distribution, metabolism, excretion (“ADME”), and drug metabolism and
pharmacokinetics (“DMPK”).
Highly customized human tissues as living, dynamic models of human biology or disease, for use in drug discovery and
development.
Three-dimensional human tissues for clinical applications, such as blood vessels for bypass grafting, nerve grafts for nerve
damage repair and functional tissue patches for the repair or replacement of damaged tissues and organs.
Our Market Opportunity
We believe that our proprietary 3D bioprinting platform enables us to deliver highly unique functional human tissues to the drug
discovery and development market and to multiple clinical markets:
1)
Standardized, Normal 3D Human Tissues for Predictive Toxicology and Preclinical Testing: We believe that our
NovoGen MMX Bioprinter delivers highly differentiated 3D tissues for use in assays aimed at predicting human clinical
outcomes. Our products in this area may replace or complement traditional two-dimensional (“2D”) cell culture based cell
assays, or cellular co-culture systems. Because our 3D tissues are made of human cells and reproduce many aspects of in
vivo tissue architecture and function, we believe they may provide advantages over non-human animal models with
respect to prediction of in vivo human outcomes. Bioprinted 3D human tissue products may be provided to the market as
kits that are sold by us or distributed by a partner. Additionally, our tissue products may be marketed as a compound
screening service, for customers who prefer to provide their compounds to a testing laboratory that will conduct short- or
long-term tests involving the exposure of our bioprinted 3D human tissues to their compound(s) and providing them with
results and samples. The compound screening service may be conducted by us or may be offered by one or more partners,
such as contract research organizations (“CROs”).
Our 3D tissue products are anticipated to be compatible with a broad range of in vitro preclinical tests, including some
aspects of assessments of ADME, DMPK, and predictive toxicology. DMPK testing is a subset of ADME. Determining
the DMPK properties of a drug helps the drug developer to better predict its safety and efficacy. The ADME and DMPK
properties of a drug essentially determine the bioavailability of that drug, including how long and at what concentrations it
is exposed to the target tissue(s). Toxicology testing is a further requirement to assess the potential for a particular drug to
seriously damage one or more organs systems while it is present in the body. Many aspects of preclinical drug testing can
be altered significantly by age, genetics, disease state, and the presence of other drugs or chemicals. Most companies
perform preclinical ADME, DMPK, and toxicology tests using a combination of biochemical and cell-based assays and
animal testing. 3D bioprinted tissue products may replace or complement traditional cell based assays that typically
employ primary hepatocytes, intestinal cell lines, renal epithelial cells and cell lines grown in traditional two-dimensional
formats. Because 3D bioprinted tissues share more features with native tissue in vivo than standard 2D cell cultures, and
they persist for extended time periods in vitro (>40 days), we believe they can provide highly differentiated and valuable
outcomes and give clients “human preclinical data” with greater depth and accuracy than has previously been possible.
Additional opportunities in this area include the testing of environmental toxins and cosmetic products on living human
tissues. Due to ethical concerns and regulatory considerations, there is a growing market opportunity for the use of 3D
human tissue models as alternatives to non-human animal studies. For example, human skin models have substantial
potential value as a means to test the effects of candidate cosmetic products prior to commercialization. We have
established a collaborative research program in this field with the intention of developing products and services for this
type of testing. In addition, many of the standard tissue models developed within this aspect of our business may be used
to assess the potential human health impacts and toxicological properties of a large number of chemical products,
environmental toxins, or biowarfare agents.
2)
Specialized 3D Tissue Models for Drug Discovery and Development: Our NovoGen bioprinting platform, comprised
of multicellular inputs (“bio-ink”) and a family of bioprinters with unique capabilities, can produce highly specialized
human tissues that model physiology or disease. We have used our bioprinting platform to create a wide array of human
tissues, including blood vessels, liver tissues, skin tissues, kidney tissues, lung tissues, and tumor tissues. 3D bioprinted
tissues possess unique features, including cell type-specific compartments, prevalent intercellular tight junctions, and
microvascular structures. These features facilitate the development of complex, multicellular disease models for use in the
development of targeted therapeutics for cardiovascular disease, lung disease, liver disease, kidney disease, and oncology.
Market opportunities within this aspect of our business may include externally-partnered or internally-directed drug
discovery and the clinical development and commercialization of new molecular entities using highly customized 3D
tissue models.
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3)
Implantable 3D Tissues for Therapeutic Use: Cell- and tissue-based therapeutic products have advanced through
research and development via multiple strategic approaches, with current clinical efforts in the field focused on systemic
or localized delivery of cell suspensions or surgical installation of combination products that consist of a predominant
biomaterial component and cellular component(s). The architectural precision and flexibility of our bioprinting platform
may facilitate the prototyping, optimization, development, and clinical use of three-dimensional tissue constructs.
Importantly, our platform enables all or part of a three-dimensional tissue to be generated without dependence on
scaffolding or biomaterial components, using only living cells as raw materials. The ultimate goal is to construct
surgically implantable tissues that restore significant functional mass to a damaged tissue or organ after delivery. It is our
belief that, in most cases, whole organ replacement will not be required to achieve meaningful clinical outcomes and
address unmet medical needs. Three-dimensional tissues with tightly defined architecture and composition can create a
new product category within cell and tissue therapies. Tissue products may include bioprinted tissues (patches, tubes, etc.)
or hybrids comprised of bioprinted tissues and device component(s). We may develop specific tissue targets with partners
through technology licenses and royalty-bearing deals, and may self-fund the development of additional tissue targets
through preclinical and clinical development.
Background on Bioprinting
The formation of ‘bio-ink’, the cell-based building blocks that can be dispensed by our suite of NovoGen Bioprinters®, relies on the
demonstrated principle that groups of individual cells will self-assemble to generate aggregates, through the actions of cell surface
proteins that bind to each other and form junctions between cells. Furthermore, if two or more compatible self-assembled aggregates
are placed in close proximity, under the proper conditions they will merge to generate larger, more complex structures via physical
properties analogous to those that drive fusion of liquid droplets. The concept of tissue liquidity originated in studies of developmental
biology, where it was noted that developing tissues have liquid-like properties that enable individual cellular components to pattern
each other, migrate, organize, and differentiate. As development progresses, tissues transition from a dynamic viscous liquid state to a
more static semi-solid state, largely driven by the compartmentalized organization of cellular components and production within the
organized tissue of extracellular matrix proteins that provide the mature tissue with the biomechanical properties required for tissue
specific function.
Early publications describing scaffold-free bioprinting demonstrate self-assembly and tissue liquidity using cellular aggregates
generated from developing chicken heart tissue, showing that adjacent aggregates will fuse over time and generate a larger cellular
structure. This basic behavior can be leveraged to form more complex structures whereby aggregates are arranged in a specific
geometry that can recapitulate shapes and architectures commonly found in tissues and organs, including tubes and multi-layered
structures.
Additional published results demonstrated that the observed fusion of aggregates in embryonic tissue can be extended to adult-derived
cultured mammalian cells, as demonstrated by the fusion of adult hamster ovary epithelial cell aggregates to form toroid (ring)
structures when placed into that geometry and held for about 120 hours.
The NovoGen Bioprinter® Platform
Our NovoGen Bioprinters are automated devices that enable the fabrication of 3D living tissues comprised of mammalian cells. A
custom graphic user interface (“GUI”) facilitates the 3D design and execution of scripts that direct precision movement of multiple
dispensing heads to deposit defined cellular building blocks called bio-ink. Bio-ink can be formulated as a 100% cellular composition
or as a mixture of cells and other matter (hydrogels, particles, etc.). Our NovoGen Bioprinters can also dispense pure hydrogel
formulations provided the physical properties of the hydrogel are compatible with the dispensing parameters. Most typically,
hydrogels are deployed to create void spaces within specific locations in a 3D tissue or to aid in the deposition of specific cell types.
We employ a wide variety of proprietary cell- and hydrogel-based bio-inks in the fabrication of tissues. Our NovoGen Bioprinters also
serve as important components of our tissue prototyping and manufacturing platform, as they are able to rapidly and precisely
fabricate intricate small-scale tissue models for in vitro use as well as larger-scale tissues suitable for in vivo use.
Our first-generation NovoGen MMX Bioprinter™ went from in-licensing and initial design to commercial production in less than two
years. Our efforts in systems engineering are focused on ensuring the continuous improvement and evolution of our NovoGen
Bioprinters to meet the needs of internally driven and externally partnered tissue programs. To date, several generations of NovoGen
Bioprinters have been designed, developed, and released for tissue production.
Generation of bio-ink building blocks is the first step in bioprinting. A wide variety of cells can serve as the raw materials for bio-ink,
including cell lines, primary cells, stromal cells, epithelial cells, endothelial cells, and progenitor cells. The majority of tissue designs
employ two or more distinct varieties of bio-ink, usually comprised of cells that represent distinct compartments within a target tissue.
For example, a 3D tumor might consist of both stromal and epithelial bio-inks, a vascular tube may consist of both fibroblast and
smooth muscle bio-inks, and a liver tissue may consist of two bio-inks made from distinct liver cell types. Our NovoGen Bioprinters
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dispense two or more bio-inks layer by layer in the geometry specified by the user, with bio-inert hydrogels serving as an optional
physical support for the bioprinted tissue as well as occupying any negative space included in the design.
Our NovoGen MMX BioprinterTM is a powerful enabling tool for the design, optimization, and fabrication of viable functional human
tissues, based on our internal product discovery and development efforts as well as the experience of our corporate partners and
customers. Continuous use of NovoGen Bioprinters in the pursuit of multiple in vitro and in vivo applications provides key insights
that drive design features and specifications for next-generation instrumentation. We believe that we are uniquely positioned to deliver
commercially viable 3D tissue products for drug development and clinical uses.
We currently collaborate with the following institutions, providing access to our NovoGen Bioprinters for research purposes: Yale
School of Medicine, University of California, San Francisco (“UCSF”), Knight Cancer Institute at Oregon Health & Science
University (“OHSU”), the National Center for Advancing Translational Sciences (“NCATS”) and the National Eye Institute (“NEI”).
We believe that the use of our bioprinting platform by major research institutes will help to advance the basic capabilities of the
platform and generate new and exciting applications for bioprinted tissues, ultimately creating future opportunities for our commercial
products and intellectual property licensing.
Research Collaborations
We currently have research collaborations with pharmaceutical, biotechnology and cosmetic companies, academic and research
institutions and government agencies. These collaborations are focused on a variety of research projects, including: developing tissue-
based drug discovery assays and tissues, developing more clinically predictive in vitro three-dimensional cancer models, exploring the
use of our 3D liver tissues in toxicology, and exploring the use of 3D skin for testing skin care products. Our collaborations with
pharmaceutical and biotechnology companies generally involve the partner providing research funding to cover, in part or in full, the
scope of work. This funding is typically reflected as revenues in our financial statements. Upon entering into a collaboration, we
disclose the financial details only to the extent that they are material to our business. Our academic and research institute
collaborations typically involve both us and the academic partner contributing resources directly to projects, but also may involve
sponsored research agreements where we fund specific research programs. We may also contribute a bioprinter and technical support
or a bioprinter plus research headcount, depending on the project scope.
Our Products and Product Candidates
We have utilized and intend to utilize our bioprinting technology to develop functional human tissues that can be employed in drug
discovery and development, biological research and as therapeutic implants. Our first commercial tissue offered is exVive3D™
Human Liver Tissue, which was designed to be used for predictive preclinical testing of drug compounds. In April 2014, we
announced that we had begun to sign contracts with pharmaceutical and biotechnology companies for toxicity research services using
our 3D Human Liver Tissue. In November 2014, we began to offer 3D Human Liver services more broadly. We currently focus on
contract research services, though we also intend to offer our 3D Human Liver Tissue directly to end user customers as a product in a
kit for toxicological and other testing over time. Our second commercial product under development is our 3D Human Kidney Tissue.
Similar to our 3D Human Liver Tissue, we are designing our 3D Human Kidney Tissue to be used for predictive preclinical testing of
drug compounds.
Samsara Sciences
In January 2016, we announced that our wholly-owned subsidiary, Samsara Sciences, Inc. (“Samsara”), commenced commercial
operations. We formed Samsara to serve as a key source of certain of the primary human cells we utilize in our products and services
and in the development of therapeutic products. We believe Samsara can help us optimize our supply chain and operating expenses
related to cell sourcing and procurement and ensure that the cellular raw materials we use are of the highest quality and are derived
from tissues that are ethically sourced in full compliance with state and federal guidelines. Samsara has begun providing us with
qualified liver cells for use in our 3D Human Liver Tissue manufacturing, and certain other human cells for use in our preclinical
research and development programs. In addition to serving as one of our key suppliers, Samsara offers human cells for use by life
science customers, both directly or through distribution partners.
Competition
We are subject to significant competition from pharmaceutical, biotechnology, and diagnostic companies; academic and research
institutions; and government or other publicly-funded agencies that are pursuing the development of tissue models and therapeutic
products that otherwise address the needs of our potential customers. We believe our future success will depend, in large part, on our
ability to maintain a competitive position in our field. Biopharmaceutical technologies have undergone and are expected to continue to
undergo rapid and significant change. We or our competitors may make rapid technological developments which may cause our
research tools or therapeutic products to become obsolete before we recover the development expenses we have incurred. The
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introduction of less expensive or more effective therapeutic discovery and development technologies, including technologies that may
be unrelated to our field, may also make our technology or products less valuable or obsolete. We may not be able to make the
necessary enhancements to our technologies or products to compete successfully with newly emerging technologies. The failure to
maintain a competitive position in the biopharmaceutical field may result in decreased revenues.
We are a platform technology company dedicated to the development and production of functional human tissues that service the drug
discovery and development, biological research, and cell- and tissue-based therapy industries.
Set forth below is a discussion of competitive factors for each of the broad markets in which we intend to utilize our technology:
1)
Standardized 3D Tissues for in vitro Preclinical Testing: We intend to employ our technology to provide an array of
broadly applicable 3D tissue models for use in preclinical assessments of safety and efficacy as an adjunct or alternative to
animal studies. Examples of products in this segment of the business include cell-based models for ADME/TOX/DMPK
markets.
We believe that we are the first and only company to leverage a bioprinting system in the commercial production of 3D
tissue products. Importantly, our fabrication platform remains highly unique in its ability to fabricate 3D tissues from
human cells without reliance on biomaterial scaffolding. Consequently, the tissues that we produce have unique features
that to date have not been attainable in 3D tissues generated by alternative strategies. Specifically, we believe the dense
cellularity, compartmentalized 3D geometry, and microarchitectural features of our bioprinted tissues offer unparalleled in
vitro modeling of native tissues. Current competition in this area, and predominant market share, arises mainly from two
sources, traditional cell-based in vitro culture approaches and traditional in vivo animal models and testing. Additional
competition exists from non-bioprinted cell-based assays offered by such companies as InSphero AG, Ascendance
Biotechnology, Inc., RegeneMed Inc., and Hurel Corporation, some of which have a three-dimensional aspect. Although
assays from these companies have limited market share today, they may improve market share and competitive position in
the future. Future competition may also exist from companies developing cellular models “on a chip”, such as Emulate, or
developing tissues with alternative biofabrication methods, such as Cyfuse.
Specialized Models for Drug Discovery and Development: This aspect of our business is driven by leveraging our
technology as a high-end partnered service that designs and delivers highly complex, custom tissue models of normal or
diseased tissue for use in drug discovery and development. Each model is designed to enable a customer to discover or
optimally formulate a pharmacologic product that delivers a specific therapeutic effect, or avoids a particular side effect.
In addition to revenue generated from the tissue production work, additional revenues are possible in the form of up-front
license fees, milestone payments, know-how payments, and royalties. We can provide the customer access to tissues as a
service or can produce and supply the tissues to customers; both options are designed to generate continuing revenue.
Competition in this area arises mainly from two sources, traditional cell-based in vitro culture approaches and traditional
in vivo animal models and testing. Future competition from companies like Cyfuse Biomedical (including service
companies using their instrument platform), and Aspect Biosystems is also possible.
We believe that an important factor distinguishing our approach from that of our competitors is our ability to build models
that are composed of human cells and have a 3D tissue-like configuration (i.e., able to generate results that are not subject
to inherent limitations of 2D monolayer culture). We acknowledge, however, that there are some areas of research for
which the existing methods (2D cell culture and/or animal studies) are adequate and 3D in vitro human tissues are not
sufficiently advantageous on a cost basis.
Implantable 3D Tissues for Clinical Use: This aspect of our business involves application of our 3D bioprinting
technology to generate human tissues suitable for implantation in vivo to augment or replace damaged or degenerating
tissues. These efforts will be undertaken by us alone, or as partnered projects with leading therapeutic companies seeking
to develop a therapeutic tissue product for a specific application. Near-term revenues would come from the funding of
development work and, in some cases, licensing fees for access to our platform technologies. We expect longer-term
revenues may arise from shared profits and royalties or other forms of income from successful clinical and commercial
development of the tissue products. There are many companies pursuing the discovery, development, and
commercialization of tissue-based products for a variety of applications, including but not limited to Organogenesis and
Cyfuse. These companies uniquely represent potential competition for us while also being partner candidates. Our
platform has the ability to enable the generation and optimization of unique, scaffold-free or hybrid tissue prototypes and
ultimately support production of the tissue.
2)
3)
Research and Development
We continuously engage in research and development to enhance our platform technology, to develop new products and service
offerings and to pursue our therapeutic initiatives. Our research and development efforts include internal initiatives as well as
collaborative development opportunities with third parties. Our research and development expenses were $18.0 million, $12.9 million
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and $8.0 million for the fiscal years ended March 31, 2016, March 31, 2015, and March 31, 2014, respectively. We focus our research
and development activities in areas where we have technological expertise and where we believe a significant market opportunity
exists for our technology and the products and services we develop. We intend to continue our focus on research and development as a
key strategy for the growth of our business.
Intellectual Property
Our success depends in large part on our ability to establish and protect our proprietary technologies and our products and services.
We rely on a combination of patents, trademarks, trade secrets and a variety of contractual mechanisms such as confidentiality,
material transfer, licenses, and invention assignment agreements, to protect our intellectual property. Our intellectual property
portfolio for our core technology was initially built through licenses from the University of Missouri-Columbia (“MU”) and the
Medical University of South Carolina. We have subsequently expanded our intellectual property portfolio by filing patent applications
and negotiating additional licenses and purchases.
We own or hold exclusive licenses to 12 issued U.S. patents and 22 pending U.S. patent applications. Outside of the U.S., we own or
hold exclusive licenses to 15 issued patents and over 90 pending applications, related to our bioprinting technology and its various
uses in areas of tissue creation, in vitro testing, and utilization in drug discovery, including filings covering specific tissue constructs.
In-Licensed IP
In 2009 and 2010, we obtained world-wide exclusive licenses to intellectual property owned by MU and the Medical University of
South Carolina, which now includes 6 issued U.S. patents, 4 pending U.S. applications, 8 issued international patents and 15 pending
international applications. Dr. Gabor Forgacs, one of our founders and the George H. Vineyard Professor of Biophysics at MU, was
one of the co-inventors of all of these works (collectively, the “Forgacs Intellectual Property”). The Forgacs Intellectual Property
provides us with intellectual property rights relating to cellular aggregates, the use of cellular aggregates to create engineered tissues,
and the use of cellular aggregates to create engineered tissue with no scaffold present. The intellectual property rights derived from the
Forgacs Intellectual Property also enables us to utilize our NovoGen MMX Bioprinter to create engineered tissues.
In 2011, we obtained an exclusive license to a U.S. patent (U.S. Pat. No. 7,051,654) owned by the Clemson University Research
Foundation that provides us with intellectual property rights relating to methods of using ink-jet printer technology to dispense cells,
and relating to the creation of matrices of bioprinted cells on gel materials.
The patent rights we obtained through these exclusive licenses are not only foundational within the field of 3D Bioprinting, but
provide us with favorable priority dates. We are required to make ongoing royalty payments under these exclusive licenses based on
net sales of products and services that rely on the intellectual property we in-licensed. For additional information regarding our royalty
obligations see Note 7 to Consolidated Financial Statements “Licensing Agreements and Research Contracts” in our audited financial
statements that are included in this Annual Report.
Company Owned IP
In addition to the IP we have in-licensed, we have continued to innovate and grow our IP portfolio.
With respect to our bioprinting platform, we have 3 issued U.S. patents directed to our NovoGen MMX Bioprinter and methods of
bioprinting: U.S. Patent No. 8,931,880; No. 9,149,952; and No. 9,227,339. We have additional U.S. continuation applications
pending in this family as well foreign counterpart applications in multiple countries. We recently received a notice of allowance in the
U.S. for a patent in a second family covering additional features of our bioprinter. Additional continuation applications are pending in
the U.S. in this second family, as well as foreign counterpart applications in multiple countries. We intend to continue pursuing patent
protection as we continue to innovate in relation to the design, features, and functionality of our bioprinter platform and bioprinting
methods.
Organovo is also pursuing U.S. and foreign patents covering our 3D bioprinted tissues and methods of fabricating such tissues. Our
exVive3D Human Liver Tissue is protected by U.S. Patent No. 9,222,932. We have additional U.S. patent applications pending in this
family, as well as foreign counterpart applications in multiple countries. We currently have pending numerous patent applications in
the U.S. and globally that are directed to additional types of tissues, their methods of fabrication, and specific applications. We intend
to continue filing additional patent applications as we continue to innovate in this area.
We believe that protection of the proprietary nature of our products and technologies is essential to our business. Accordingly, we
have adopted and will continue a vigorous program to secure and maintain protection of our intellectual property. Under this program,
we intend to continue to file patent applications with respect to novel technology, and improvements thereof, that are important to our
business. We also will continue to rely upon trade secret protection of our methods and technology. As with other areas of
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biotechnology, this provides a critical adjunct to the protection offered by patents. As always, we continue to pursue our internal
technological innovation and external licensing opportunities to develop and maintain our competitive position. There can be no
assurance that others will not independently develop substantially equivalent proprietary technology or that we can meaningfully
protect our proprietary position.
Regulatory Considerations
We are not aware of any current FDA regulatory requirements for sales or use of 3D tissue models for use in research applications. All
human cells utilized in our research activities and, ultimately in our bioprinted tissue products, are collected in compliance with the
FDA’s guidance for current Good Tissue Practices (cGTP). However, our collaboration partners face regulatory review of the research
data generated using our technology platform and research tools. Good Laboratory Practice (GLP) data is required in the development
of any human therapeutic, and our technology platform has been designed to support compliance with GLP, although no independent
certification has been performed to date to confirm this compliance. In addition, as our constructs move into clinical and commercial
settings, full compliance with the FDA’s cGTP (current Good Tissue Practices) and cGMP (current Good Manufacturing Practices)
guidelines will be required. Suitable design and documentation for clinical use of the bioprinter will be a part of future phases of our
NovoGen Bioprinter® design programs.
Therapeutic tissues and other regenerative medicine products are subject to an extensive, lengthy and uncertain regulatory approval
process by the U.S. Food and Drug Administration (FDA) and comparable agencies in other countries. The regulation of new products
is extensive, and the required process of laboratory testing and human studies is lengthy and expensive. The resource investment
necessary to meet the requirements of these regulations will fall on our collaborating partners, or may be shared with us, to the extent
that we are developing proprietary products that are the result of a collaboration effort. The resource investment of time, staff and
expense to satisfy these regulations will fall on us for the proprietary products we are developing on our own. We may not be able to
obtain FDA approvals for those products in a timely manner, or at all. We may encounter significant delays or excessive costs in our
efforts to secure necessary approvals or licenses. Even if we obtain FDA regulatory approvals, the FDA extensively regulates
manufacturing, labeling, distributing, marketing, promotion and advertising after product approval. Moreover, several of our product
development areas may involve relatively new technology and have not been the subject of extensive product testing in humans. The
regulatory requirements governing these products and related clinical procedures remain uncertain and the products themselves may
be subject to substantial review by the FDA and/or foreign governmental regulatory authorities that could prevent or delay approval of
these products and procedures. Regulatory requirements ultimately imposed on our products could limit our ability to test,
manufacture and, ultimately, commercialize our products and thereby could adversely affect our financial condition and results of
operations.
Raw Materials
We use live human cells to produce our 3D tissues. We formed our wholly-owned subsidiary, Samsara Sciences, Inc. (“Samsara”), to
serve as a key source of the primary human cells we utilize in our products and services and in the development of therapeutic
products. Samsara is currently supplying us with qualified human liver cells for use in manufacturing our exVive 3D Human Liver
Tissue, as well as certain cells for research and development activities. We believe that Samsara can help us optimize our supply chain
and operating expenses and ensure that the human cells we utilize for our services, products and research and development programs
are of the highest quality and are derived from tissues that are ethically sourced in full compliance with state and federal guidelines. In
addition to Samsara, we also purchase human cells from selected third-party suppliers based on quality assurance, cost effectiveness,
and regulatory requirements. We work closely with Samsara and our third-party suppliers to assure continuity of supply while
maintaining high quality and reliability. Although we believe we have adequate available sources of raw materials, there can be no
guarantee that we will be able to access the quantity of raw material needed to meet our demands on a timely basis or at a cost
effective price.
Employees
As June 1, 2016, we have 116 employees, of whom 115 are employed full time. We also engage consultants and temporary employees
from time to time to provide services that relate to our bioprinting business and technology as well as for general administrative
services.
Available Information
Our investor relations website is located at http://ir.organovo.com. We are subject to the reporting requirements of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”). Reports filed with the SEC pursuant to the Exchange Act, including annual
and quarterly reports, and other reports we file, are available free of charge, through our website, and we make them available on the
website as soon as reasonably possible after we file them with the SEC. The content of our website is not intended to be incorporated
by reference into this report or in any other report or document that we file.
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The reports we file with the SEC can also be inspected and copied at the public reference facilities maintained by the SEC at 100 F
Street, N.E., Washington, D.C. 20549. Investors may obtain information on the operation of the public reference room by calling the
SEC at 1-800-SEC-0330. Investors can request copies of these documents upon payment of a duplicating fee by writing to the SEC.
The reports we file with the SEC are also available on the SEC’s website (http://www.sec.gov).
Item 1A. Risk Factors.
Investment in our common stock involves a substantial degree of risk and should be regarded as speculative. As a result, the purchase
of our common stock should be considered only by persons who can reasonably afford to lose their entire investment. Before you elect
to purchase our common stock, you should carefully consider the risk and uncertainties described below in addition to the other
information incorporated herein by reference. Additional risks and uncertainties of which we are unaware or which we currently
believe are immaterial could also materially adversely affect our business, financial condition or results of operations. If any of the
risks or uncertainties discussed in this Annual Report occur, our business, prospects, liquidity, financial condition and results of
operations could be materially and adversely affected, in which case the trading price of our common stock could decline, and you
could lose all or part of your investment.
Risks Related to Our Business and Our Industry
We have a limited operating history and a history of operating losses, and expect to incur significant additional operating losses.
We were incorporated in 2007, and opened our laboratories in San Diego, California in January 2009. Since our incorporation, we
have focused primarily on the development of our platform technology and the development of our biological research, drug discovery
and therapeutic products and services based on that technology. In April 2014, we announced that we had begun to sign contracts for
research services using our 3D Human Liver Tissue product, and in November 2014, we announced the full commercial release of our
first product, the exVive3D™ Human Liver Tissue for use in toxicology and other preclinical drug testing. Because of our limited
commercial operating history, investors have limited historical financial or other information upon which to base an evaluation of our
performance and future prospects. Moreover, our future prospects must be considered in light of the uncertainties, risks, expenses, and
difficulties frequently encountered by companies in their early stages of operations and competing in new and rapidly developing
technology areas. We have generated operating losses each year since we began operations, including $38.6 million, $30.3 million,
and $20.6 million for the years ended March 31, 2016, 2015, and 2014, respectively. As of March 31, 2016, we had incurred
cumulative operating losses of $107.2 million and cumulative net losses totaling $160.9 million. We expect to incur substantial
additional operating losses over the next several years as our research, development, and commercial activities increase. The amount
of future losses and when, if ever, we will achieve profitability are uncertain. Our ability to generate revenue and achieve profitability
will depend on, among other things:
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successfully developing drug discovery, biological research, and therapeutic tools, products and services that are more
effective than existing technologies and can be offered at competitive prices;
entering into collaborative relationships with strategic partners;
obtaining any necessary regulatory approval for our drug discovery, biological research, and therapeutic tools, products and
services;
entering into successful manufacturing, sales and marketing arrangements with third parties or developing an effective sales
and marketing infrastructure to commercialize our products and services; and
raising sufficient funds to finance our activities and long-term business plan.
We might not succeed at any of these undertakings. If we are unsuccessful at one or more of these undertakings, our business,
prospects, and results of operations will be materially adversely affected.
We are an early-stage company with an unproven business strategy, and may never achieve profitability.
We are in the early stages of using our proprietary platform technology to develop and commercialize functional human tissues that
can be employed in drug discovery and development, biological research, and potentially as therapeutic implants for the treatment of
damaged or degenerating tissues and organs. Our success will depend upon the commercial viability of our platform technology, as
well as on our ability to determine which drug discovery, biological research, and therapeutic tools, products and services can be
successfully developed and commercialized with our platform technology. Our success will also depend on our ability to increase
customer awareness and demand for our products and services, to enter into additional collaboration agreements on favorable terms
and to select an appropriate commercialization strategy for the products and services we or our collaborators choose to pursue. If we
are not successful in implementing our development and commercialization strategies, which are new and unproven, and/or if we
underprice or overrun our cost estimates for our contracts or our development and commercialization activities, we may never achieve
profitability, or even if we achieve profitability, we may not be able to maintain or increase our profitability.
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We may not be able to correctly estimate our future revenues and operating expenses, which could lead to cash shortfalls, and
require us to secure additional financing sooner than planned.
We may not correctly predict the amount or timing of future revenues and our operating expenses may fluctuate significantly in the
future as a result of a variety of factors, many of which are outside of our control. These factors include:
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our expectations regarding revenues from sales of our products and services, and from collaborations with third parties;
the time and resources required to develop our drug discovery, biological research, and therapeutic tools, products and
services;
the time and cost of obtaining any necessary regulatory approvals;
we may elect to pursue additional research and development programs as part of our long-term business plan;
the cost and time required to create effective sales and marketing capabilities and commercialization strategies;
the expenses we incur to maintain and improve our platform technology;
the costs to attract and retain personnel with the skills required for effective operations; and
the costs of preparing, filing, prosecuting, defending and enforcing patent claims and other patent related costs, including
litigation costs and the results of such litigation.
In addition, our budgeted expense levels are based in part on our expectations concerning future revenues from sales of our products
and services, and from collaborations with third parties. However, we may not correctly predict the amount or timing of future
revenues. In addition, we may not be able to adjust our operations in a timely manner to compensate for any unexpected shortfall in
our revenues or we may increase our expenses as part of implementing our long-term business plan. As a result, a significant shortfall
in our planned revenues or a significant increase in our planned expenses could have an immediate and material adverse effect on our
business and financial condition. In such case, we may be required to issue additional equity or debt securities or enter into other
commercial arrangements, including relationships with corporate and other partners, sooner than anticipated to secure the additional
financial resources to support our development efforts and future operations.
We may need to secure additional financing to support our long-term business plans.
We may require additional funds to support our long-term business plans. We expect that we may be required to issue additional
equity or debt securities or enter into other commercial arrangements, including relationships with corporate and other partners, to
secure the additional financial resources to support our development efforts and to implement our long-term business plans.
Depending upon market conditions, we may not be successful in raising sufficient additional capital on a timely basis, on favorable
terms, or at all. Additionally, the issuance of additional equity securities, including securities convertible into or exercisable for our
equity securities, would result in the dilution of the ownership interests of our present stockholders. If we fail to obtain sufficient
additional financing, or enter into relationships with others that provide additional financial resources, we may not be able to develop
our technology and products in accordance with our long-term business plan, and we may be required to delay significantly, reduce
the scope of or eliminate one or more of our research or development programs, downsize our general and administrative
infrastructure, or seek alternative measures to raise additional funds.
Our platform technology and our drug discovery, biological research, therapeutic tools, products and services are new and
unproven.
Our platform technology, as well as our drug discovery, biological research, therapeutic tools, products and services, involve new and
unproven models and approaches. We only began offering our first commercial product (and related research services), our 3D Human
Liver Tissue, on a limited basis in April 2014 and more broadly in November 2014. The second product (and related research
services) we are developing is our 3D Human Kidney Tissue, which we plan to offer for predictive preclinical testing of drug
compounds. As a result, we have had a limited time to prove that our 3D Human Liver Tissue and related services will enable our
customers to conduct drug discovery and biological research more effectively than through the use of existing technologies. Our 3D
Human Kidney Tissue and our other products under development are unproven at this time, and there is no assurance that they will
perform as expected or as required by our customers. Our success depends on the commercial acceptance of, and the success of our
efforts to increase customer awareness and demand for, our drug discovery and biological research tools, products and services. Even
if we or our collaborators are successful in our respective efforts, we or our collaborators may not be able to discover or develop
commercially viable therapeutics or other products therefrom. To date, there has not been sufficient time for our collaborators to
develop or commercialize any therapeutic products based on our drug discovery and biological research tools, products and services.
If our drug discovery and biological research tools, products and services do not assist in the discovery and development of such
therapeutic products, our current and potential collaborators may lose confidence in us and our drug discovery and biological research
tools, products and services. Our inability to successfully develop effective and competitive drug discovery, biological research, tools,
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products and services and achieve and maintain commercial acceptance for those tools, products and services would materially
adversely affect our business, financial condition and results of operations.
Our technology, products and services are subject to the risks associated with new and rapidly evolving technologies and
industries.
Our proprietary tissue creation technology and our drug discovery, biological research, therapeutic tools, products and services are
subject to the risks associated with new, rapidly evolving technologies and industries. We may experience unforeseen technical
complications, unrecognized defects and limitations in the development and commercialization of our tools, products and services,
including our 3D Human Liver and Kidney Tissues. These complications could materially delay or limit the use of those tools,
products and services, substantially increase the anticipated cost of manufacturing, or prevent us or our collaborators from
implementing their drug discovery or biological research projects successfully or at all. In addition, the process of developing new
technologies, products and services is complex, and if we are unable to develop enhancements to, and new features for, our existing
products and services or acceptable new products and services that keep pace with technological developments or industry standards,
our products and services may become obsolete, less marketable and less competitive.
Our ability to successfully commercialize the drug discovery, biological research, and therapeutic tools, products and services we
develop is subject to a variety of risks.
The commercialization of our drug discovery and biological research tools and products are subject to risks and uncertainties,
including:
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failing to develop products or services that are effective and competitive;
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failing to demonstrate the commercial and technical viability of any products or services that we successfully develop or
otherwise failing to achieve market acceptance of such products or services;
failing to be cost effective;
failing to obtain any necessary regulatory approvals;
being difficult or impossible to manufacture on a large scale;
being unable to establish and maintain supply and manufacturing relationships with reliable third parties;
being unable to obtain a sufficient supply of human cells for our products, services and research and development
activities on a timely basis and at acceptable quality levels and costs;
failing to develop our products and services before the successful marketing of similar products and services by
competitors;
being unable to hire and retain qualified personnel; and
infringing the proprietary rights of third parties or competing with superior products marketed by third parties.
If any of these or any other risks and uncertainties occur, our efforts to commercialize our drug discovery and biological research
tools, products and services may be unsuccessful, which would harm our business and results of operations.
The near and long-term viability of our products and services will depend on our ability to successfully establish strategic
relationships.
The near and long-term viability of our products and services will depend in part on our ability to successfully establish new strategic
collaborations with biotechnology companies, pharmaceutical companies, universities, hospitals, insurance companies and
government agencies. Establishing strategic collaborations is difficult and time-consuming. Potential collaborators may reject
collaborations based upon their assessment of our technology or product offerings or our financial, regulatory or intellectual property
position. If we fail to establish a sufficient number of collaborations on acceptable terms, we may not be able to commercialize our
products or generate sufficient revenue to fund further research and development efforts. Even if we establish new collaborations,
these relationships may never result in the successful development or commercialization of any product or service candidates for
several reasons both within and outside of our control.
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We cannot control our collaborators’ allocation of resources or the amount of time that our collaborators devote to developing our
programs or potential products, which may have a material adverse effect on our business.
Our existing research and collaboration agreements typically allow our collaborators to obtain the options to license or exclusive rights
to negotiate licenses to our new technologies. Our collaborators may have significant discretion in electing whether to pursue product
development, regulatory approval, manufacturing and marketing of the products they may develop with the help of our technology.
We cannot control the amount and timing of resources our collaborators may devote to our programs or potential products. As a result,
we cannot be certain that our collaborators will choose to develop and commercialize these products or that we will realize any future
milestone payments, royalties and other payments provided for in the agreements with our collaborators. In addition, if a collaborator
is involved in a business combination, such as a merger or acquisition, or if a collaborator changes its business focus, its performance
pursuant to its agreement with us may suffer. As a result, we may not generate any revenues from royalty, milestone and similar
provisions that may be included in our collaborative agreements.
In addition, our collaborative partners or other customers that utilize our research tools will be required to submit their research for
regulatory review in order to proceed with human testing of drug candidates. This review by the FDA and other regulatory agencies
may result in timeline setbacks or complete rejection of an application to begin human studies, such as an Investigative New Drug
(IND) application, or the ultimate failure to receive the regulatory approval required to commercialize the drug candidate or product.
Should our collaborative partners or other customers face such setbacks, we would be at risk of not earning any future milestone or
royalty payments.
Any termination or breach by or conflict with our collaborators or licensees could harm our business.
If we or any of our existing or future collaborators or licensees fail to renew or terminate any of our collaboration or license
agreements, or if either party fails to satisfy its obligations under any of our collaboration or license agreements or complete them in a
timely manner, we could lose significant sources of revenue, which could result in volatility in our future revenues. In addition, our
agreements with our collaborators and licensees may have provisions that give rise to disputes regarding the rights and obligations of
the parties. These and other possible disagreements could lead to termination of the agreement or delays in collaborative research,
development, supply or commercialization of certain products, or could require or result in litigation or arbitration. Moreover,
disagreements could arise with our collaborators over rights to our intellectual property or our rights to share in any of the future
revenues of products developed by our collaborators. These kinds of disagreements could result in costly and time-consuming
litigation. Any such conflicts with our collaborators could reduce our ability to obtain future collaboration agreements and could have
a negative impact on our relationship with existing collaborators, adversely affecting our business and revenues. Finally, any of our
collaborations or license agreements may prove to be unsuccessful.
Our collaborators could develop competing research tools or services, reducing the available pool of potential collaborators and
increasing competition, which may adversely affect our business and revenues.
Our collaborators and potential collaborators could develop research tools similar to our own, reducing our pool of possible
collaborative parties and increasing competition. Any of these developments could harm our commercialization efforts, which could
seriously harm our business. In addition, we may pursue opportunities in fields that could conflict with those of our collaborators.
Developing products and services that compete with our collaborators’ or potential collaborators’ products and services could preclude
us from entering into future collaborations with our collaborators or potential collaborators. Any of these developments could harm
our product development efforts and could adversely affect our business and revenues.
We face intense competition which could result in reduced acceptance and demand for our products and services.
The biotechnology industry is subject to intense competition and rapid and significant technological change. We have many potential
competitors, including major drug companies, specialized biotechnology firms, academic institutions, government agencies and
private and public research institutions. Many of these competitors have significantly greater financial and technical resources,
experience and expertise in the following areas than we do:
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research and technology development;
product identification and development;
regulatory processes and approvals;
production and manufacturing;
securing government contracts and grants to support their research and development efforts; and
sales and marketing of products, services and technologies.
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Principal competitive factors in our industry include the quality, price and breadth of technology and services; management and the
execution of product development and commercialization strategies; skill and experience of employees, including the ability to recruit
and retain skilled, experienced employees; intellectual property portfolio; range of capabilities, including product identification,
development, manufacturing and marketing; and the availability of substantial capital resources to fund these activities. Please see
Item 1. “Business – Competition” for a further description of the competition for our products and services, including the identity of
certain of our significant competitors.
In order to effectively compete, we will need to make substantial investments in our research and technology development, product
identification and development, testing and regulatory approval, manufacturing, customer awareness activities, publications of our
technology and results in scientific publications and sales and marketing activities. There is no assurance that we will be successful in
commercializing and gaining significant market share for any products or services we offer in part through use of our technology. Our
technologies, products and services also may be rendered obsolete or noncompetitive as a result of products and services introduced
by our competitors.
Our current therapeutic product candidate portfolio is in the early stages of development.
We are in the early stages of developing potential therapeutic products based on our proprietary technology. There is no assurance that
we can successfully identify and develop therapeutic products, prove that they are safe and efficacious in clinical trials, or meet
applicable regulatory standards. Given the potential costs of these therapeutic programs, we may pursue licensing, partnering and
other strategic alternatives to help fund further investigation and clinical development, but there is no assurance that we will be able to
do so based on their early stage of development. As a result, we may not be successful in developing, showing clinical efficacy,
obtaining regulatory approval or raising the required capital for any therapeutic programs we identify and elect to pursue.
We may have product liability exposure from the sale of our research tools and therapeutic products or the services we provide.
We may have exposure to claims for product liability. Product liability coverage is expensive and sometimes difficult to obtain. There
can be no assurance that our existing insurance coverage will extend to other products in the future. Our product liability insurance
coverage may not be sufficient to satisfy all liabilities resulting from product liability claims. A successful claim may prevent us from
obtaining adequate product liability insurance in the future on commercially desirable items, if at all. Even if a claim is not successful,
defending such a claim would be time-consuming and expensive, may damage our reputation in the marketplace, and would likely
divert management’s attention.
We may be dependent on third-party research organizations to conduct some of our future laboratory testing, animal and human
studies.
We may be dependent on third-party research organizations to conduct some of our laboratory testing, animal and human studies with
respect to therapeutic tissues and other life science products that we may develop in the future. If we are unable to obtain any
necessary testing services on acceptable terms, we may not complete our product development efforts in a timely manner. If we rely
on third parties for laboratory testing and/or animal and human studies, we may lose some control over these activities and become too
dependent upon these parties. These third parties may not complete testing activities on schedule or when we so request. We may not
be able to secure and maintain suitable research organizations to conduct our laboratory testing and/or animal and human studies. We
are responsible for confirming that each of our clinical trials is conducted in accordance with our general plan and protocol. Moreover,
the FDA and foreign regulatory agencies require us to comply with regulations and standards, commonly referred to as good clinical
practices, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and
accurate and that the trial participants are adequately protected. Our reliance on third parties does not relieve us of these
responsibilities and requirements. If these third parties do not successfully carry out their contractual duties or regulatory obligations
or meet expected deadlines, if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised
due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development
activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval
for our future product candidates.
We will require access to a constant, steady, reliable supply of human cells to successfully commercialize our tools and products.
We require a reliable supply of human cells for our commercial products and services and for our research and development activities.
We also purchase qualified human cells from selected third-party suppliers based on quality assurance, cost effectiveness, and
regulatory requirements. We formed our wholly-owned subsidiary,Samsara, to eventually serve as a key source of the primary human
cells we utilize in our business. We will utilize a combination of third party suppliers and Samsara to meet our overall future demand
for human cells. We work closely with Samsara and our third-party suppliers to assure adequate supply while maintaining high quality
and reliability. Although we believe we have adequate available sources of raw materials to meet our commercial demands, there can
be no guarantee that we will be able to access the quantity and quality of raw materials needed at a cost effective price. Any failure to
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obtain a reliable supply of human cells at cost effective prices will harm our business and our results of operations, and could cause us
to be unable to comply with the contractual obligations we owe to our customers and collaboration partners.
If our laboratory facilities become inoperable, we will lose access to our 3D bioprinters and tissues, and our ability to conduct our
business and comply with our contractual obligations will be harmed.
We manufacture our NovoGen Bioprinters® and our 3D Human Liver Tissues at our laboratory facilities in San Diego, California.
We also provide research services to our customers and collaboration partners and conduct our product research and development
activities at our laboratory facilities in San Diego, California. We do not currently have redundant laboratory facilities. Our San Diego,
California laboratory facilities are situated near active earthquake fault lines. Our facilities may be harmed or rendered inoperable by
natural or manmade disasters, including earthquakes, flooding, fires, power outages and contamination, which may render it difficult
or impossible for us to continue to provide our products and services and engage in our research and development activities for some
period of time. Even if our facilities are inoperable for even a short period of time, we may suffer the loss of our existing tissue and
cell inventory, and the loss of any research services and activities currently in process. Accordingly, any disruption to operations at
our laboratory facilities in San Diego, California would materially affect our business, prospects and results of operations.
We currently rely on third-party suppliers for some of our materials, including our supply of human cells, and we may rely on
third-party manufacturers in the future to produce our tools and products.
We rely on third-party suppliers and vendors for some of the human cells and other materials we utilize in our products and services
and in our research and development activities. We currently acquire our human cells from Samsara and third-party suppliers. Any
significant problem experienced by one of our suppliers could result in a delay or interruption in the supply of materials to us until
such supplier resolves the problem or an alternative source of supply is located. Any delay, interruption or inability to obtain an
adequate supply of human cells would negatively affect our operations. In addition, in the future we may require access to, or
development of, facilities to manufacture a sufficient supply of our tools and products. If we are unable to manufacture our products in
commercial quantities or the third-parties on which we rely to manufacture our tools and products fail to perform as anticipated, our
business and future growth will suffer.
We may not be successful in establishing Samsara as a profitable commercial business.
In January 2016, we announced that our wholly-owned subsidiary, Samsara, commenced commercial operations. We formed Samsara
to serve as a key source of certain of the primary human cells we utilize in our products and services and in the development of
therapeutic products. In addition to supplying human cells for our business requirements, we believe there is an opportunity for
Samsara to operate as a commercial business by selling human cells to other pharmaceutical, biotech and research organizations.
Samsara has begun selling its human cell offerings to end users both directly and through distribution partners. Operating and
developing Samsara’s business is subject to a number of risks and uncertainties, including:
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failing to source a sufficient supply of high quality human cells;
failing to achieve market acceptance for its human cell offerings;
failing to demonstrate the quality and reliability of its human cell offerings;
failing to be both cost effective and competitive with the products offered by third parties;
failing to obtain any necessary regulatory approvals;
failing to be able to produce its human cell offerings on a large scale;
failing to establish and maintain distribution relationships with reliable third parties;
failing to hire and retain qualified personnel; and
infringing the proprietary rights of third parties.
If any of these or any other risks and uncertainties occur, our efforts to establish Samsara as a commercial business may be
unsuccessful, which would harm our business and results of operations.
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A significant portion of our sales will be dependent upon our customers’ capital spending policies and research and development
budgets, and government funding of research and development programs at universities and other organizations, which are each
subject to significant and unexpected decrease.
Our prospective customers include pharmaceutical and biotechnology companies, academic institutions, government laboratories, and
private research foundations. Fluctuations in the research and development budgets at these organizations could have a significant
effect on the demand for our products and services. Research and development budgets fluctuate due to changes in available
resources, patent expirations, mergers of pharmaceutical and biotechnology companies, spending priorities, general economic
conditions, and institutional and governmental budgetary policies, including but not limited to reductions in grants for research by
federal and state agencies as a result of the current budget crises and budget reduction measures. In addition, our business could be
seriously damaged by any significant decrease in life sciences research and development expenditures by pharmaceutical and
biotechnology companies, academic institutions, government laboratories, or private foundations.
The timing and amount of revenues from customers that rely on government funding of research may vary significantly due to factors
that can be difficult to forecast. Research funding for life science research has increased more slowly during the past several years
compared to the previous years and has declined in some countries, and some grants have been frozen for extended periods of time or
otherwise become unavailable to various institutions, sometimes without advance notice. Government funding of research and
development is subject to the political process, which is inherently fluid and unpredictable. Other programs, such as homeland security
or defense, or general efforts to reduce the federal budget deficit could be viewed by the United States government as a higher priority.
These budgetary pressures may result in reduced allocations to government agencies that fund research and development activities.
National Institute of Health and other research and development allocations have been diminished in recent years by federal budget
control efforts. The prolonged or increased shift away from the funding of life sciences research and development or delays
surrounding the approval of government budget proposals may cause our customers to delay or forego purchases of our products or
services, which could seriously damage our business.
An inability to manage our planned growth or expansion of our operations could adversely affect our business, financial condition
or results of operations.
Our business operations and activities have grown rapidly, and we expect this growth to continue as we expand our ability to develop
and commercialize functional human tissues. The rapid expansion of our business and addition of new personnel may place a strain on
our management and operational systems. To effectively manage our operations and growth, we must continue to expend funds to
enhance our operational, financial and management controls, reporting systems and procedures and to attract and retain sufficient
numbers of talented employees. In addition, our management will need to continue to successfully:
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expand and our research and product development efforts;
implement and expand our sales, marketing and customer support programs;
expand, train and manage our employee base; and
effectively address new issues related to our growth as they arise.
We may not manage our planned growth and expansion successfully, which could adversely affect our business, financial condition or
results of operations.
Our business will be adversely impacted if we are unable to successfully attract and hire key additional employees or if we are
unable to retain our executive officers and other key personnel.
Our future success depends in part on our ability to timely attract and hire a highly skilled and experienced Chief Financial Officer as
well as the other technical, managerial and sales and marketing personnel required to support our business. Our success will also
depend to a significant degree upon the continued contributions of our key personnel, especially our executive officers. We do not
currently have long-term employment agreements with our executive officers or our other key personnel, and there is no guarantee
that our executive officers or key personnel will remain employed with us. Moreover, we have not obtained key man life insurance
that would provide us with proceeds in the event of the death, disability or incapacity of any of our executive officers or other key
personnel. Further, the process of attracting and retaining suitable replacements for any executive officers and other key personnel we
lose in the future would result in transition costs and would divert the attention of other members of our senior management from our
existing operations. Additionally, such a loss could be negatively perceived in the capital markets. As a result, the loss of any of our
executive officers or other key personnel or our inability to timely attract and hire qualified personnel in the future (in particular
skilled technical, managerial and sales and marketing personnel) will adversely impact our ability to meet our key commercial and
technical goals and successfully implement our business plan.
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We may be subject to security breaches or other cybersecurity incidents that could compromise our information and expose us to
liability.
We routinely collect and store sensitive data (such as intellectual property, proprietary business information and personally
identifiable information) for the Company, its employees and its suppliers and customers. We make significant efforts to maintain the
security and integrity of our computer systems and networks and to protect this information. However, like other companies in our
industry, our networks and infrastructure may be vulnerable to cyber-attacks or intrusions, including by computer hackers, foreign
governments, foreign companies or competitors, or may be breached by employee error, malfeasance or other disruption. Any such
breach could result in unauthorized access to (or disclosure of) sensitive, proprietary or confidential information of ours, our
employees or our suppliers or customers, and/or loss or damage to our data. Any such unauthorized access, disclosure, or loss of
information could cause competitive harms, result in legal claims or proceedings, liability under laws that protect the privacy of
personal information, and/or cause reputational harm.
We are subject to risks associated with doing business outside the United States.
We do business with customers outside the United States. We intend to continue to pursue customers and growth opportunities in
international markets, and we expect that international revenues may account for a significant percentage of our revenues in the
foreseeable future. There are a number of risks arising from our international business, including those related to:
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foreign currency exchange rate fluctuations, potentially reducing the United States dollars we receive for sales
denominated in foreign currency;
general economic and political conditions in the markets we operate in;
potential increased costs associated with overlapping tax structures;
potential trade restrictions and exchange controls;
more limited protection for intellectual property rights in some countries;
difficulties and costs associated with staffing and managing foreign operations;
unexpected changes in regulatory requirements;
the difficulties of compliance with a wide variety of foreign laws and regulations; and
longer accounts receivable cycles in certain foreign countries, whether due to cultural differences, exchange rate
fluctuation or other factors.
These risks, individually or in the aggregate, could have an adverse effect on our results of operations and financial condition. For
example, we are subject to compliance with the United States Foreign Corrupt Practices Act and similar anti-bribery laws, which
generally prohibit companies and their intermediaries from making improper payments to foreign government officials for the purpose
of obtaining or retaining business. While our employees are required to comply with these laws, we cannot be sure that our internal
policies and procedures will always protect us from violations of these laws, despite our commitment to legal compliance and
corporate ethics. The occurrence or allegation of these types of risks may adversely affect our business, performance, prospects, value,
financial condition, and results of operations.
Risks Related to Government Regulation
Violation of government regulations or quality programs could harm demand for our products or services, and the evolving nature
of government regulations could have an adverse impact on our business.
To the extent that our collaborators or customers use our products in the manufacturing or testing processes for their drug and medical
device products, such end-products or services may be regulated by the FDA under Quality System Regulations (QSR) or the Centers
for Medicare & Medicaid Services (CMS) under Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) regulations. The
customer is ultimately responsible for QSR, CLIA’88 and other compliance requirements for their products. However, we may agree
to comply with certain requirements, and, if we fail to do so, we could lose sales and our collaborators or customers and be exposed to
regulatory delays or objections and potential product liability claims. In addition, our platform technology is subject to the
requirements of Good Laboratory Practice (GLP) to provide suitable data for INDs and other regulatory filings. No regulatory review
of data from our platform technology has yet been conducted and there is no guarantee that our technology will be acceptable under
GLP. As a result, the violation of government regulations or quality programs could harm demand for our products or services, and the
evolving nature of government regulations could have an adverse impact on our business.
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Any therapeutic implants we develop will be subject to extensive, lengthy and uncertain regulatory requirements, which could
adversely affect our ability to obtain regulatory approval in a timely manner, or at all.
Any therapeutic and other life science products we develop will be subject to extensive, lengthy and uncertain regulatory approval
process by the Food and Drug Administration (FDA) and comparable agencies in other countries. The regulation of new products is
extensive, and the required process of laboratory testing and clinical studies is lengthy, expensive and uncertain. We may not be able
to obtain FDA approvals for any therapeutic products we develop in a timely manner, or at all. We may encounter significant delays or
excessive costs in our efforts to secure necessary approvals or licenses. Even if we obtain FDA regulatory approvals, the FDA
extensively regulates manufacturing, labeling, distributing, marketing, promotion and advertising after product approval. Moreover,
several of our product development areas may involve relatively new technologies and have not been the subject of extensive
laboratory testing and clinical studies. The regulatory requirements governing these products and related clinical procedures remain
uncertain and the products themselves may be subject to substantial review by the FDA and other foreign governmental regulatory
authorities that could prevent or delay approval in the United States and any other foreign country. Regulatory requirements ultimately
imposed on our products could limit our ability to test, manufacture and, ultimately, commercialize our products and thereby could
adversely affect our financial condition and results of operations.
As we continue to adapt and develop parts of our product line in the future, including tissue-based products in the field of regenerative
medicine, the manufacture and marketing of our products will become subject to government regulation in the United States and other
countries. In the United States and most foreign countries, we will be required to complete rigorous preclinical testing and extensive
human clinical trials that demonstrate the safety and efficacy of a product in order to apply for regulatory approval to market the
product. The steps required by the FDA before our proposed products may be marketed in the United States include performance of
preclinical (animal and laboratory) tests; submissions to the FDA of an IDE (Investigational Device Exemption), NDA (New Drug
Application), or BLA (Biologic License Application) which must become effective before human clinical trials may commence;
performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the product in the intended
target population; performance of a consistent and reproducible manufacturing process intended for commercial use; Pre-Market
Approval Application (PMA); and FDA approval of the PMA before any commercial sale or shipment of the product.
The processes are expensive and can take many years to complete, and we may not be able to demonstrate the safety and efficacy of
our products to the satisfaction of such regulatory authorities. The start of clinical trials can be delayed or take longer than anticipated
for many and varied reasons, many of which are outside of our control. Safety concerns may emerge that could lengthen the ongoing
trials or require additional trials to be conducted. Regulatory authorities may also require additional testing, and we may be required to
demonstrate that our proposed products represent an improved form of treatment over existing therapies, which we may be unable to
do without conducting further clinical studies. Moreover, if the FDA grants regulatory approval of a product, the approval may be
limited to specific indications or limited with respect to our distribution. Expanded or additional indications for approved devices or
drugs may not be approved, which could limit our revenues. Foreign regulatory authorities may apply similar limitations or may
refuse to grant any approval. Consequently, even if we believe that preclinical and clinical data are sufficient to support regulatory
approval for our product candidates, the FDA and foreign regulatory authorities may not ultimately grant approval for commercial sale
in any jurisdiction. If our products are not approved, our ability to generate revenues will be limited and our business will be adversely
affected.
Even if a product gains regulatory approval, such approval is likely to limit the indicated uses for which it may be marketed, and the
product and the manufacturer of the product will be subject to continuing regulatory review, including adverse event reporting
requirements and the FDA’s general prohibition against promoting products for unapproved uses. Failure to comply with any post-
approval requirements can, among other things, result in warning letters, product seizures, recalls, substantial fines, injunctions,
suspensions or revocations of marketing licenses, operating restrictions and criminal prosecutions. Any of these enforcement actions,
any unanticipated changes in existing regulatory requirements or the adoption of new requirements, or any safety issues that arise with
any approved products, could adversely affect our ability to market products and generate revenues and thus adversely affect our
ability to continue our business.
We also may be restricted or prohibited from marketing or manufacturing a product, even after obtaining product approval, if
previously unknown problems with the product or our manufacturer are subsequently discovered and we cannot provide assurance that
newly discovered or developed safety issues will not arise following any regulatory approval. With the use of any treatment by a wide
patient population, serious adverse events may occur from time to time that initially do not appear to relate to the treatment itself, and
only if the specific event occurs with some regularity over a period of time does the treatment become suspect as having a causal
relationship to the adverse event. Any safety issues could cause us to suspend or cease marketing of our approved products, possibly
subject us to substantial liabilities, and adversely affect our ability to generate revenues.
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If restrictions on reimbursements and health care reform limit our or our collaborators’ actual or potential financial returns on
therapeutic products that we or they develop based on our platform technology, we may not be able to recover our research and
development costs and our collaborators may reduce or terminate their collaborations with us.
Our ability to recover our research and development costs and successfully commercialize any therapeutic products we develop and
our collaborators’ abilities to successfully commercialize the therapeutic and other life science products they develop through the
research tools or services that we provide them may depend in part on the extent to which coverage and adequate payments for these
products will be available from government payers, such as Medicare and Medicaid, private health insurers, including managed care
organizations, and other third-party payers. These payers are increasingly challenging the price of medical products and services.
Significant uncertainty exists as to the reimbursement status of newly approved therapeutic and other life science products, and
coverage and adequate payments may not be available for these products.
In recent years, officials have made numerous proposals to change the health care system in the U.S. These proposals included
measures to limit or eliminate payments for some medical procedures and treatments or subject the pricing of pharmaceuticals and
other medical products to government control. Government and other third-party payers increasingly attempt to contain health care
costs by limiting both coverage and the level of payments of newly approved health care products. In some cases, they may also refuse
to provide any coverage of uses of approved products for disease indications other than those for which the FDA has granted
marketing approval. Governments may adopt future legislative proposals and federal, state or private payers for healthcare goods and
services may take action to limit their payments for goods and services. Any of these events could reduce the demand for our products
and services by our collaboration partners, reduce the proceeds we receive from our arrangements with our collaboration partners
based on future sales of their therapeutic products or limit our ability to recover our research and development costs and successfully
commercialize any therapeutic products we develop.
We use hazardous chemicals, biological materials and infectious agents in our business. Any claims relating to improper handling,
storage or disposal of these materials could be time consuming and costly.
Our product manufacturing research and development, and testing activities involve the controlled use of hazardous materials,
including chemicals, biological materials and infectious disease agents. We cannot eliminate the risks of accidental contamination or
the accidental spread or discharge of these materials, or any resulting injury from such an event. We may be sued for any injury or
contamination that results from our use or the use by third parties of these materials, and our liability may exceed our insurance
coverage and our total assets. Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal
of these hazardous materials and specified waste products, as well as the discharge of pollutants into the environment and human
health and safety matters. We are also subject to various laws and regulations relating to safe working conditions, laboratory and
manufacturing practices, and the experimental use of animals. Our operations may require that environmental permits and approvals
be issued by applicable government agencies. We also cannot accurately predict the extent of regulations that might result from any
future legislative or administrative action. Any of these laws or regulations could cause us to incur additional expense or restrict our
operations. Compliance with environmental laws and regulations may be expensive, and current or future environmental regulations
may impair our research, development or production efforts. If we fail to comply with these requirements, we could incur substantial
costs, including civil or criminal fines and penalties, clean-up costs or capital expenditures for control equipment or operational
changes necessary to achieve and maintain compliance.
Risks Related to Our Intellectual Property
If we are not able to adequately protect our proprietary rights, our business could be harmed.
Our commercial success will depend to a significant extent on our ability to obtain patents and maintain adequate protection for our
technologies, intellectual property and products and service offerings in the United States and other countries. If we do not protect our
intellectual property adequately, competitors may be able to use our technologies and gain a competitive advantage.
To protect our products and technologies, we and our collaborators and licensors must prosecute and maintain existing patents, obtain
new patents and pursue other intellectual property protection. Our existing patents and any future patents we obtain may not be
sufficiently broad to prevent others from using our technologies or from developing competing products and technologies. Moreover,
the patent positions of many biotechnology and pharmaceutical companies are highly uncertain, involve complex legal and factual
questions and have in recent years been the subject of much litigation. As a result, we cannot guarantee that:
•
•
•
any patent applications filed by us will issue as patents;
third parties will not challenge our proprietary rights, and if challenged that a court or an administrative board of a patent
office will hold that our patents are valid and enforceable;
third parties will not independently develop similar or alternative technologies or duplicate any of our technologies by
inventing around our claims;
18
•
•
•
•
any patents issued to us will cover our technology and products as ultimately developed;
we will develop additional proprietary technologies that are patentable;
the patents of others will not have an adverse effect on our business; or
as issued patents expire, we will not lose some competitive advantage.
We may not be able to protect our intellectual property rights throughout the world.
Certain foreign jurisdictions have an absolute requirement of novelty that renders any public disclosure of an invention immediately
fatal to patentability in such jurisdictions. Therefore, there is a risk that we may not be able to protect some of our intellectual property
in the United States or abroad due to disclosures, which we may not be aware of, by our collaborators or licensors. Some foreign
jurisdictions prohibit certain types of patent claims, such as “method-of-treatment/use-type” claims; thus, the scope of protection
available to us in such jurisdictions is limited.
Moreover, filing, prosecuting and defending patents on all of our potential products and technologies throughout the world would be
prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not sought or obtained patent protection
to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but
where enforcement is not as strong as that in the United States. These products may compete with our future products in jurisdictions
where we do not have any issued patents and our patent claims or other intellectual property rights may not be effective or sufficient to
prevent them from so 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 cost and divert our efforts and attention from other aspects
of our business.
We may be involved in lawsuits or other proceedings to protect or enforce our patents or the patents of our licensors, which could
be expensive, time-consuming and unsuccessful.
Competitors may infringe our patents or the patents of our collaborators or licensors. Or, our licensors may breach or otherwise
prematurely terminate the provisions of our license agreements with them. To counter infringement or unauthorized use, we may be
required to file infringement claims or lawsuits, which can be expensive and time-consuming. In addition, in an infringement
proceeding, a court may decide that a patent of ours or our collaborators or licensors 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 patents do not cover the technology in question. An
adverse result in any litigation or defense 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. Additionally, our licensors may
retain certain rights to use technologies licensed by us for research purposes. Patent disputes can take years to resolve, can be very
costly and can result in loss of rights, injunctions and substantial penalties. Moreover, patent disputes and related proceedings can
distract management’s attention and interfere with running the business.
Furthermore, because of the potential for substantial discovery in connection with intellectual property litigation, there is a risk that
some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be
public announcements of the results of hearings, motions or other interim proceedings or developments which could harm our
business.
As more companies file patents relating to bioprinters and bioprinted tissues, it is possible that patent claims relating to bioprinters or
bioprinted human tissue may be asserted against us, and any such assertions could harm our business. Moreover, we may face claims
from non-practicing entities, which have no relevant product revenue and against whom our own patent portfolio may thus have no
deterrent effect. Any such claims, with or without merit, could be time-consuming to defend, result in costly litigation and diversion of
resources, cause product shipment or delays or require us to enter into royalty or license agreements. These licenses may not be
available on acceptable terms, or at all. Even if we are successful in defending such claims, infringement and other intellectual
property litigation can be expensive and time-consuming to litigate and divert management’s attention from our core business. Any of
these events could harm our business significantly.
Our current and future research, development and commercialization activities also must satisfy the obligations under our license
agreements. Any disputes arising under our license agreements could be costly and distract our management from the conduct of our
business. Moreover, premature termination of a license agreement could have an adverse impact on our business.
19
In addition to infringement claims against us, if third parties have prepared and filed patent applications in the United States that also
claim technology to which we have rights, we may have to participate in interference proceedings in the United States Patent and
Trademark Office (“PTO”) to determine the priority of invention. An unfavorable outcome could require us to cease using the related
technology or to attempt to license rights to it from the prevailing party.
Third parties may also attempt to initiate reexamination, post grant review or inter partes review of our patents or those of our
collaborators or licensors in the PTO. We may also become involved in similar opposition proceedings in the European Patent Office
or similar offices in other jurisdictions regarding our intellectual property rights with respect to our products and technology.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
In addition to seeking patents for some of our technology and potential products, we also rely on trade secrets, including unpatented
know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets,
in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees,
corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also
enter into confidentiality and invention or patent assignment agreements with our employees and consultants that obligate them to
assign their inventions to us. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary
information, including our trade secrets, and we may not be able to obtain adequate remedies for these breaches. Alternatively, if a
third party alleges that any of our employees or consultants has breached confidentiality obligations to our benefit, we may have to
defend against allegations of trade secret misappropriation.
Enforcing or defending a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-
consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or
unwilling to protect trade secrets. Further, if any of our trade secrets were to be lawfully obtained or independently developed by a
competitor, we would have no right to prevent that competitor from using that technology or information to compete with us. If any of
our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.
We rely in part on trademarks to distinguish our products and services from those of other entities. Trademarks may be opposed or
cancelled and we may be involved in lawsuits or other proceedings to protect or enforce our trademarks.
We rely on trademarks, in the United States and in certain foreign jurisdictions, to distinguish our products and services in the minds
of consumers and our business partners from those of other entities. Third parties may challenge our pending trademark applications
through opposition proceedings in the U.S., or comparable proceedings in foreign jurisdictions, in which they seek to prevent
registration of a mark. Our registered trademarks may be subject to cancellation proceedings in the U.S., or comparable proceedings in
foreign jurisdictions, in which a third party seeks to cancel an existing registration. To enforce our trademark rights, we may be
involved in lawsuits or other proceedings which could be expensive, time-consuming and uncertain.
Risks Related to Our Common Stock and Liquidity Risks
We have a limited trading history and there is no assurance that an active market in our common stock will continue at present
levels or increase in the future.
There is limited trading history in our common stock, and although our common stock is now traded on the NYSE MKT, there is no
assurance that an active market in our common stock will continue at present levels or increase in the future. As a result, an investor
may find it difficult to dispose of our common stock on the timeline and at the volumes they desire. This factor limits the liquidity of
our common stock, and may have a material adverse effect on the market price of our common stock and on our ability to raise
additional capital.
Compliance with the reporting requirements of federal securities laws can be expensive.
We are a public reporting company in the United States, and accordingly, subject to the information and reporting requirements of the
Exchange Act and other federal securities laws, including the compliance obligations of the Sarbanes-Oxley Act. The costs of
complying with the reporting requirements of the federal securities laws, including preparing and filing annual and quarterly reports
and other information with the SEC and furnishing audited reports to stockholders, can be substantial.
20
If we fail to comply with the rules of Section 404 of the Sarbanes-Oxley Act of 2002 related to accounting controls and procedures,
or, if we discover material weaknesses and deficiencies in our internal control and accounting procedures, we may be subject to
sanctions by regulatory authorities and our stock price could decline.
Section 404 of the Sarbanes-Oxley Act (the “Act”) requires that we evaluate and determine the effectiveness of our internal control
over financial reporting and requires an attestation and report by our external auditing firm on our internal control over financial
reporting. We believe our system and process evaluation and testing comply with the management certification and auditor attestation
requirements of Section 404. We cannot be certain, however, that we will be able to satisfy the requirements in Section 404 in all
future periods, especially as we grow our business. If we are not able to continue to meet the requirements of Section 404 in a timely
manner or with adequate compliance, we may be subject to sanctions or investigation by regulatory authorities, such as the SEC or
NYSE MKT. Any such action could adversely affect our financial results or investors’ confidence in us and could cause our stock
price to fall. Moreover, if we are not able to comply with the requirements of Section 404 in a timely manner, or if we or our
independent registered public accounting firm identifies deficiencies in our internal controls that are deemed to be material
weaknesses, we may be required to incur significant additional financial and management resources to achieve compliance.
We may have undisclosed liabilities and any such liabilities could harm our revenues, business, prospects, financial condition and
results of operations.
Prior to our reverse merger in February 2012, the assets and liabilities of the public company shell we eventually merged into were
transferred in a split-off transaction (the “Split-Off”) to a separate entity (the “Split-Off Entity”) owned by the then outstanding
stockholders of the public company shell (the “Split-Off Stockholders”). Even though the pre-merger assets and liabilities were
transferred to the Split-Off Entity in the Split-Off, there can be no assurance that we will not be liable for any or all of such liabilities.
Any such liabilities that survived our reverse merger could harm our revenues, business, prospects, financial condition and results of
operations upon our acceptance of responsibility for such liabilities. The transfer of the operating assets and liabilities to Split-Off
Entity, coupled with the Split-Off, will result in taxable income to us in an amount equal to the difference between the fair market
value of the assets transferred and the pre-merger tax basis of the assets. Any gain recognized, to the extent not offset by our net
operating loss carryforward, if any, will be subject to federal income tax at regular corporate income tax rates.
The price of our common stock may continue to be volatile, which could lead to losses by investors and costly securities litigation.
The trading price of our common stock is likely to be highly volatile and could fluctuate in response to factors such as:
•
•
•
•
•
•
•
•
•
•
•
•
actual or anticipated variations in our operating results;
announcements of developments by us or our competitors, including new product and service offerings;
regulatory actions regarding our products or services;
reduced government funding for research and development activities;
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital
commitments;
adoption of new accounting standards affecting our industry;
additions or departures of key personnel;
introduction of new products by us or our competitors;
sales of our common stock or other securities in the open market;
degree of coverage of securities analysts and reports and recommendations issued by securities analysts regarding our
business;
volume fluctuations in the trading of our common stock; and
other events or factors, many of which are beyond our control.
The stock market is subject to significant price and volume fluctuations. In the past, following periods of volatility in the market price
of a company’s securities, securities class action litigation has often been initiated against such a company. Litigation initiated against
us, whether or not successful, could result in substantial costs and diversion of our management’s attention and resources, which could
harm our business and financial condition.
21
Investors may experience dilution of their ownership interests because of the future issuance of additional shares of our capital
stock.
We are authorized to issue 150,000,000 shares of common stock and 25,000,000 shares of preferred stock. As of March 31, 2016,
there were an aggregate of 109,540,165 shares of our common stock issued and outstanding on a fully diluted basis and no shares of
preferred stock outstanding. That total for our common stock includes 16,101,363 shares of our common stock that may be issued
upon the exercise of outstanding stock options or is available for issuance under our equity incentive plans, and 1,046,813 shares of
our common stock that may be issued upon the exercise of outstanding warrants.
In the future, we may issue additional authorized but previously unissued equity securities, resulting in the dilution of the ownership
interests of our present stockholders. We may also issue additional shares of our capital stock or other securities that are convertible
into or exercisable for our capital stock in connection with presently outstanding warrants, hiring or retaining employees, future
acquisitions, future sales of our securities for capital raising purposes, or for other business purposes. The future issuance of any such
additional shares of capital stock may create downward pressure on the trading price of our common stock. There can be no assurance
that we will not be required to issue additional shares, warrants or other convertible securities in the future in conjunction with any
capital raising efforts, including at a price (or exercise prices) below the price at which shares of our common stock is currently traded
on the NYSE MKT.
Our common stock is subject to trading risks created by the influence of third party investor websites.
Our common stock is widely traded and held by retail investors, and these investors are subject to the influence of information
provided by third party investor websites and independent authors distributing information on the internet. This information has
become influential because it is widely distributed and links to it appear as top company headlines on commonly used stock quote and
finance websites, or through services such as Google alerts. These emerging information distribution models are a consequence of the
emergence of the internet. Some information and content distribution is by individuals through platforms that mainly serve as hosts
seeking advertising revenue. As such, we believe an incentive exists for these sites to increase advertising revenue by increasing page
views, and for them to post or allow to be posted inflammatory information to achieve this end. It has been our experience that a
significant portion of the information on these websites or distributed by independent authors about our Company is false or
misleading, and occasionally, we believe, purposefully misleading. These sites and internet distribution strategies also create
opportunity for individuals to pursue both “pump and dump” and “short and distort” strategies. We believe that many of these
websites have little or no requirements for authors to have professional qualifications. While these sites sometimes require disclosure
of stock positions by authors, as far as we are aware these sites do not audit the accuracy of such conflict of interest disclosures. We
believe that many of these websites have few or lax editorial standards, and thin or non-existent editorial staffs. Despite our best
efforts, we have not and may not be able in the future to obtain corrections to information provided on these websites about our
Company, including both positive and negative information, and any corrections that are obtained may not be achieved prior to the
majority of audience impressions being formed for a given article. These conditions create volatility and risk for holders of our
common stock and should be considered by investors. We can make no guarantees that regulatory authorities will take action on these
types of activities, and we cannot guarantee that legislators will act responsively, or ever act at all, to appropriately restrict the
activities of these websites and authors.
Our common stock is controlled by insiders.
Our current executive officers and directors beneficially own approximately 13.2% of our outstanding shares of common stock as of
March 31, 2016. Although we are not aware of any voting arrangements between our officers and directors, such concentrated control
may adversely affect the price of our common stock. Investors who acquire our common stock may have no effective voice in the
management of our operations.
We do not intend to pay dividends for the foreseeable future.
We have paid no dividends on our common stock to date and it is not anticipated that any dividends will be paid to holders of our
common stock in the foreseeable future. While our future dividend policy will be based on the operating results and capital needs of
our business, it is currently anticipated that any earnings will be retained to finance our future expansion and for the implementation of
our business plan. As an investor, you should take note of the fact that a lack of a dividend can further affect the market value of our
stock, and could significantly affect the value of any investment.
22
Anti-takeover provisions in our organizational documents and Delaware law may discourage or prevent a change of control, even
if an acquisition would be beneficial to our stockholders, which could affect our stock price adversely and prevent attempts by our
stockholders to replace or remove our current management.
Our certificate of incorporation and bylaws contain provisions that could delay or prevent a change of control of our company or
changes in our Board of Directors that our stockholders might consider favorable. Some of these provisions:
•
•
•
•
authorize the issuance of preferred stock which can be created and issued by the Board of Directors without prior
stockholder approval, with rights senior to those of the common stock;
provide for a classified Board of Directors, with each director serving a staggered three-year term;
prohibit our stockholders from filling board vacancies, calling special stockholder meetings, or taking action by written
consent; and
require advance written notice of stockholder proposals and director nominations.
In addition, we are subject to the provisions of Section 203 of the Delaware General Corporation Law, which may prohibit certain
business combinations with stockholders owning 15% or more of our outstanding voting stock. These and other provisions in our
certificate of incorporation, bylaws and Delaware law could make it more difficult for stockholders or potential acquirers to obtain
control of our Board of Directors or initiate actions that are opposed by our then-current Board of Directors, including delaying or
impeding a merger, tender offer, or proxy contest involving our company. Any delay or prevention of a change of control transaction
or changes in our Board of Directors could cause the market price of our common stock to decline.
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
Since July 2012, the Company has leased its main facility at 6275 Nancy Ridge Drive, San Diego, CA 92121, consisting of
approximately 30,895 rentable square feet containing laboratory, clean room and office space. Monthly rental payments are
approximately $83,000 per month with 3% annual escalators. The lease term expires September 1, 2021 with the option to terminate
on or after September 1, 2019. The Company also has a right of first refusal on adjacent additional premises of approximately 14,500
square feet.
On January 9, 2015, the Company entered into an agreement to lease a second facility consisting of 5,803 rentable square feet of
office and lab space located at 6310 Nancy Ridge Drive, San Diego, CA 92121. The term of the lease is 36 months, beginning on
February 1, 2015 and ending on January 31, 2018, with monthly rental payments of approximately $12,000 commencing on April 1,
2015. In addition, there are annual rent escalations of 3% on each 12-month anniversary of the lease commencement date.
On December 28, 2015, the Company entered into an agreement to lease a third facility consisting of 12,088 rentable square feet of
office space located at 6166 Nancy Ridge Drive, San Diego, CA 92121. The term of the lease is 12 months, beginning on February 1,
2016 and ending on January 31, 2017, with monthly rental payments of $15,000 commencing on February 1, 2016.
Item 3. Legal Proceedings.
The Company is not involved in any material legal proceedings or legal matters at this time. See Note 6 of the Notes to the
Consolidated Financial Statements contained within this Annual Report on Form 10-K for a further discussion of potential
commitments and contingencies related to legal proceedings.
Item 4. Mine Safety Disclosures.
Not applicable.
23
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information for Common Stock
On February 8, 2012, Organovo, Inc., a privately held Delaware corporation, merged with and into Organovo Acquisition Corp., a
wholly-owned subsidiary of the Company, a publicly traded Delaware corporation, with Organovo, Inc. surviving the merger as a
wholly-owned subsidiary of the Company (the “Merger”). Organovo Holdings, Inc. commenced trading on the QB tier of the OTC on
February 15, 2012, and upgraded from the QB to the QX tier of the OTC on October 8, 2012. On July 11, 2013, the Company’s shares
began trading on the NYSE MKT under the symbol “ONVO”.
The following table sets forth, on a per share basis, for the periods indicated, the high and low bid or sales prices of our common
stock.
Year Ended March 31, 2016
Fourth Quarter
Third Quarter
Second Quarter
First Quarter
Year Ended March 31, 2015
Fourth Quarter
Third Quarter
Second Quarter
First Quarter
High
Low
2.64 $
3.48 $
4.13 $
5.82 $
1.60
2.37
1.90
3.50
High
Low
7.42 $
7.68 $
9.25 $
9.10 $
3.29
5.35
6.17
5.12
$
$
$
$
$
$
$
$
As of March 31, 2016, we had 92,391,989 outstanding shares of common stock, with a closing price of $2.17 per share. On this date,
there were 100 holders of record of the Company’s common stock.
Dividend Policy
We have never declared or paid any cash dividends on our common stock. We currently intend to retain all future earnings, if any, for
use in our business and do not anticipate paying any cash dividends on our common stock in the foreseeable future.
Recent Sales of Unregistered Securities
None.
24
Performance Graph
This performance graph is furnished and shall not be deemed “filed” with the SEC or subject to Section 18 of the Exchange Act, nor
shall it be deemed incorporated by reference in any of our filings under the Securities Act of 1933, as amended.
The graph set forth below compares our total stockholder returns since we commenced trading on February 15, 2012 through March
31, 2016 to two indices: the NASDAQ Composite Index and the NASDAQ Biotechnology Index. This graph assumes the investment
of $100 on February 15, 2012 in our common stock, the NASDAQ Composite Index and the NASDAQ Biotech Index, and assumes
the reinvestment of dividends. No cash dividends have been declared or paid on our common stock. The comparisons in the graph
below are required by the SEC and are not intended to forecast or be indicative of possible future performance of our common stock,
and we do not make or endorse any predictions as to future stockholder returns.
Stock Price Performance Graph
D
O
L
L
A
R
S
500.00
450.00
400.00
350.00
300.00
250.00
200.00
150.00
100.00
50.00
0.00
2/15/12
3/31/12
3/31/13
3/31/14
3/31/15
3/31/16
Organovo Holdings, Inc.
NASDAQ Composite
NASDAQ Biotechnology
Organovo Holdings, Inc. — ONVO
NASDAQ Composite — IXIC
NASDAQ Biotechnology — NBI
Equity Compensation Plans
February 15,
2012
100.00
100.00
100.00
March 31,
2012
149.70
106.03
102.25
March 31,
2013
223.03
112.06
133.23
March 31, March 31,
2015
2014
463.03 214.55
144.01 168.08
197.05 287.10
March 31,
2016
131.52
167.01
217.65
The following table summarizes information about the Company’s equity compensation plans by type as of March 31, 2016 (in
thousands, except per share amounts):
Number of
securities to be
issued upon
exercise/vesting
of outstanding
Plan category
Equity compensation plans approved by
security holders
Equity compensation plans not approved by
security holders
options, warrants, Weighted average
units and rights
(1)
exercise price
(1)
Number of
securities available
for future issuance
9,835,997 $
4.12
6,486,736
—
—
—
(1) Does not include outstanding restricted stock units for 6,250 shares of common stock as of March 31, 2016.
25
Item 6. Selected Financial Data (in thousands except per share data).
You should read the following selected consolidated financial data in conjunction with our consolidated financial statements, the notes
to the consolidated financial statements and Item 7—“Management’s Discussion and Analysis of Financial Condition and Results of
Operations” included elsewhere in this report. The selected consolidated financial data included in this section are not intended to
replace the consolidated financial statements and the related notes included elsewhere in this report.
On March 31, 2013, our Board of Directors approved a change in our fiscal year end from December 31st to March 31st. As a result of
this change, we filed a Transition Report on Form 10-K/T for the three-month transition period ended March 31, 2013. References to
any of our pre-2013 fiscal years mean the fiscal years ending on December 31st.
The table below shows selected consolidated financial data. The consolidated statements of operations data for the years ended March
31, 2016, 2015 and 2014, and the consolidated balance sheet data at March 31, 2016 and 2015 are derived from our consolidated
financial statements included elsewhere in this report. The consolidated statement of operations data for the three months ended March
31, 2013 and 2012 and the years ended December 31, 2012 and 2011 and the consolidated balance sheet data as of March 31, 2014,
2013 and 2012, and as of December 31, 2012 and 2011 are derived from our consolidated financial statements not included in this
report. The historical results presented below are not necessarily indicative of financial results to be achieved in future periods.
Year
Ended
March 31,
2016
Year
Ended
March 31,
2015
Year
Ended
March 31,
2014
Three Months
Ended
March 31,
2013
Three Months
Ended
March 31,
2012
(unaudited)
Year
Ended
Year
Ended
December 31, December 31,
2012
2011
$
$
$
$
1,483
(38,643 )
(38,575 )
(0.43 )
$
$
$
$
$
571
(30,297) $
(30,082) $
(0.38) $
379
$
(20,649) $
(25,848) $
(0.35) $
215
$
(4,025) $
(16,120) $
(0.26) $
120
(1,329 )
(37,081 )
(1.17 )
$
$
$
$
1,197
$
(9,319) $
(43,553) $
(1.01) $
969
(2,305)
(4,383)
(0.19)
90,057,356
79,650,087
73,139,618
61,750,157
31,591,663
43,149,657
22,925,694
March 31,
2016
March 31,
2015
March 31,
2014
March 31,
2013
March 31,
2012
(unaudited)
December 31, December 31,
2012
2011
Selected Consolidated
Statement of Operations Data:
Revenue
Operating loss
Net loss
Loss per share, basic and diluted
Weighted average shares
outstanding, basic and diluted
Selected Consolidated
Balance Sheet Data:
Working capital (deficit)
Total assets
Long-term liabilities
Stockholders’ equity (deficit)
$
$
$
$
59,162
67,576
905
62,181
$
$
$
$
46,501
53,489
32
48,696
$
$
$
$
47,268
50,186
9
48,284
$
$
$
$
7,762
17,375
24
8,969
$
$
$
$
9,724
11,241
47,515
(37,385 )
$
$
$
$
(6,169) $
$
16,749
$
17
(5,303) $
(946)
1,409
1,267
(1,835)
26
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following management’s discussion and analysis of financial condition and results of operations should be read in conjunction
with our historical consolidated financial statements and the related notes. This management’s discussion and analysis contains
forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and
intentions. Any statements that are not statements of historical fact are forward-looking statements. These forward-looking statements
are subject to risks and uncertainties that could cause our actual results or events to differ materially from those expressed or implied
by the forward-looking statement. Factors that could cause or contribute to such differences include, but are not limited to, those
identified below and those discussed in the section entitled “Risk Factors” included elsewhere in this Annual Report. Except as
required by applicable law we do not undertake any obligation to update forward-looking statements to reflect events or
circumstances occurring after the date of this Annual Report.
The management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial
statements, which we have prepared in accordance with U.S. generally accepted accounting principles. 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 consolidated financial statements, as well as the reported revenues and
expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments, including those described in
greater detail below. 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. Our actual results may differ from these estimates under different assumptions or
conditions.
Overview
We are an early commercial stage company focusing on developing and commercializing functional human tissues that can be
employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or
degenerating tissues and organs. We intend to introduce a paradigm shift in the approach to the generation of three-dimensional
human tissues, by utilizing our proprietary platform technology to create human tissue constructs in 3D that mimic native human
tissue composition, architecture and function. We intend to leverage our unique 3D human tissue models to improve the current
industry standard cell-based and animal model testing approaches to drug discovery and development by creating 3D tissues
constructed solely of human cells. We believe our foundational approach to the 3D printing of living tissues, as disclosed in peer-
reviewed scientific publications, and the continuous evolution of our core bioengineering technology platform combine to provide us
with the opportunity to fill many critical gaps in commercially available preclinical human tissue modeling and tissue transplantation.
In November 2014, we announced the commercial release of our first product, the exVive3DTM Human Liver Tissue for use in
toxicology and other preclinical drug testing. Initial revenues derived from the product have been and will continue to be
predominantly through our research service model, which involves testing compounds provided to us for analysis by our customers.
Prior to initiating the service, our technical staff assists customers in determining the extent of testing to be conducted utilizing our
exVive3D Human Liver Tissue. Testing may include the analysis of one or multiple compounds under various dosing and duration
protocols to determine toxicity and metabolic effects of the test compounds on the tissue model. Projects may involve multiple
deliverables, which are clearly defined and based on pricing as stated in the related customer agreements. Consistent with our revenue
recognition policies, revenue related to each deliverable will be recognized when delivered and the period of customer acceptance has
been met. Revenue from projects without multiple deliverables will be recognized when the data package has been delivered to the
customer and the term of customer acceptance has been met. In general, project duration is in the four to six month range.
In addition to our exVive3D Human Liver Tissue product and research service contracts, we have entered into collaborative research
agreements with pharmaceutical corporations and academic medical centers. We have also secured federal grants, including Small
Business Innovation Research grants, to support the development of our technology.
We continuously engage in research and development to enhance our platform technology, to develop new product and service
offerings and to pursue our therapeutic initiatives. Our research and development efforts include internal initiatives as well as
collaborative development opportunities with third parties. Our second commercial product under development is our 3D Human
Kidney Tissue. Similar to our 3D Human Liver Tissue, we are designing our 3D Human Kidney Tissue to be used for predictive
preclinical testing of drug compounds.
In January 2016, we announced that our wholly-owned subsidiary, Samsara, commenced commercial operations. We formed Samsara
to serve as a key source of certain of the primary human cells that we utilize in our products and services and in the development of
therapeutic products. In addition to serving as one of our key suppliers, Samsara offers human cells for use by life science customers,
both directly or through distribution partners.
27
Reverse Merger Transaction
On February 8, 2012 (the “Closing Date”), Organovo Acquisition Corp., a wholly-owned subsidiary of Organovo Holdings, Inc. (“the
Company”), merged (the “Merger”) with and into Organovo, Inc., a privately held Delaware corporation (“Organovo”). Organovo was
the surviving corporation of that Merger, and became a wholly-owned subsidiary of the Company. As a result of the Merger, the
Company acquired the business of Organovo, and has continued the existing business operations of Organovo.
Simultaneously with the Merger, on the Closing Date, all of the issued and outstanding shares of Organovo common stock converted,
on a 1 for 1 basis, into shares of the Company’s common stock, par value $0.001 per share (“Common Stock”). Also on the Closing
Date, all of the issued and outstanding options to purchase shares of Organovo Common Stock, all of the issued and outstanding
Bridge Warrants (as defined below) to purchase shares of Organovo Common Stock, and other outstanding warrants to purchase
Organovo Common Stock converted, respectively, into options (the “New Options”), new bridge warrants (the “New Bridge
Warrants”) and new warrants (the “New Warrants”) to purchase shares of Common Stock on a 1 for 1 basis. The New Options are
being administered under Organovo’s 2008 Equity Incentive Plan (the “2008 Plan”), which the Company assumed and adopted on the
Closing Date in connection with the Merger.
Specifically, on the Closing Date, (i) 22,445,254 shares of Common Stock were issued to former Organovo stockholders; (ii) New
Options to purchase 896,256 shares of Common Stock granted under the 2008 Plan were issued to optionees pursuant to the
assumption of the 2008 Plan; (iii) New Warrants to purchase 1,309,750 shares of Common Stock at $1.00 per share were issued to
holders of Organovo warrants; and (iv) New Bridge Warrants to purchase 1,500,000 shares of Common Stock at $1.00 per share were
issued to Bridge Investors (as defined below).
Additionally, New Warrants to purchase 100,000 shares of Common Stock at $1.00 per share were issued to a former note holder of
Organovo in connection with the repayment at the Closing Date of a promissory note in the principal amount of $100,000.
The Merger was treated as a recapitalization of the Company for financial accounting purposes. The historical financial statements of
Organovo Holdings, Inc. before the Merger were replaced with the historical financial statements of Organovo before the Merger.
In connection with the Merger, Organovo Holdings, Inc.’s Board of Directors and stockholders adopted the 2012 Equity Incentive
Plan (the “2012 Plan”). The 2012 Plan, as amended on August 20, 2015, provides for the issuance of up to 17,553,986 shares to
executive officers, directors, advisory board members, consultants and employees. In addition, we assumed and adopted the 2008
Plan, and as described above option holders under that plan were granted New Options to purchase Common Stock. No further options
will be granted under the 2008 Plan. The parties have taken all actions necessary to ensure that the Merger was treated as a tax-free
exchange under Section 368(a) of the Internal Revenue Code of 1986, as amended.
As of June 1, 2016, the Company had 92,391,989 total issued and outstanding shares of Common Stock, and four- and five-year
warrants for the opportunity to purchase an additional 1,046,813 shares of Common Stock at exercise prices ranging from $0.85 to
$7.62 per share. The Company had outstanding stock options to purchase an aggregate of 9,600,089 shares of Common Stock at
exercise prices ranging from $0.08 to $9.92 and 6,250 outstanding unvested restricted stock units, with each unit representing the right
to receive one share of Common Stock.
Critical Accounting Policies
Our consolidated financial statements include the accounts of the Company as well as its wholly-owned subsidiaries, with all material
intercompany accounts and transactions eliminated in consolidation, which appear under Item 8 of Part II, and have been prepared in
accordance with accounting principles generally accepted in the United States, which require that we make certain assumptions and
estimates and, in connection therewith, adopt certain accounting policies. Our significant accounting policies are set forth in Note 1 to
our consolidated financial statements. Of those policies, we believe that the policies discussed below may involve a higher degree of
judgment and may be more critical to an accurate reflection of our financial condition and results of operations.
Revenue Recognition
The Company derives its revenues from research service agreements, product sales, collaborative research agreements, and grants
from the National Institutes of Health (“NIH”), U.S. Treasury Department and private not-for-profit organizations.
The Company recognizes revenue when the following criteria have been met: (i) persuasive evidence of an arrangement exists;
(ii) services have been rendered or product has been delivered; (iii) price to the customer is fixed and determinable; and (iv) collection
of the underlying receivable is reasonably assured.
28
Billings to customers or payments received from customers are included in deferred revenue on the balance sheet until all revenue
recognition criteria are met.
Revenue Arrangements with Multiple Deliverables
The Company follows ASC 605-25 Revenue Recognition – Multiple-Element Arrangements for revenue arrangements that contain
multiple deliverables. Judgment is required to properly identify the accounting units of the multiple deliverable transactions and to
determine the manner in which revenue should be allocated among the accounting units. Moreover, judgment is used in interpreting
the commercial terms and determining when all criteria of revenue recognition have been met for each deliverable in order for revenue
recognition to occur in the appropriate accounting period. For multiple deliverable agreements, consideration is allocated at the
inception of the agreement to all deliverables based on their relative selling price. The relative selling price for each deliverable is
determined using vendor-specific objective evidence (“VSOE”) of selling price or third-party evidence of selling price if VSOE does
not exist. If neither VSOE nor third-party evidence of selling price exists, the Company uses its best estimate of the selling price for
the deliverable. While changes in the allocation of the arrangement consideration between the units of accounting will not affect the
amount of total revenue recognized for a particular sales arrangement, any material changes in these allocations could impact the
timing of revenue recognition, which could affect the Company’s results of operations.
The Company periodically receives license fees for non-exclusive research licensing associated with funded research projects. License
fees under these arrangements are recognized over the term of the contract or development period as it has been determined that such
licenses do not have stand-alone value.
Revenue from Research Service Agreements
For research service agreements that contain only a single or primary deliverable, the Company defers any up-front fees collected
from customers, and recognizes revenue for the delivered element only when it determines there are no uncertainties regarding
customer acceptance. For agreements that contain multiple deliverables, the Company follows ASC 605-25 as described above.
Research and Development Revenue under Collaborative Agreements
The Company’s collaboration revenue consists of license and collaboration agreements that contain multiple elements, including non-
refundable up-front fees, payments for reimbursement of third-party research costs, payments for ongoing research, payments
associated with achieving specific development milestones and royalties based on specified percentages of net product sales, if any.
The Company considers a variety of factors in determining the appropriate method of revenue recognition under these arrangements,
such as whether the elements are separable, whether there are determinable fair values and whether there is a unique earnings process
associated with each element of a contract.
The Company recognizes revenue from research funding under collaboration agreements when earned on a “proportional
performance” basis as research services are provided or substantive milestones are achieved. We recognize revenue that is contingent
upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. A milestone is
considered substantive when the consideration payable to us for the milestone (i) is consistent with our performance necessary to
achieve the milestone or the increase in value to the collaboration resulting from our performance, (ii) relates solely to our past
performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. In making this
assessment, we consider all facts and circumstances relevant to the arrangement, including factors such as the risks that must be
overcome to achieve the milestone, the level of effort and investment required to achieve the milestone and whether any portion of the
milestone consideration is related to future performance or deliverables.
The Company initially defers revenue for any amounts billed or payments received in advance of the services being performed, and
recognizes revenue pursuant to the related pattern of performance, using the appropriate method of revenue recognition based on its
analysis of the related contractual element(s).
Product Revenue
The Company recognizes product revenue at the time of shipment to the customer, provided all other revenue recognition criteria have
been met. To date, the Company has not recognized significant revenue from commercial product sales.
As our commercial sales increase, we expect to establish a reserve for estimated product returns that will be recorded as a reduction to
revenue. This reserve will be maintained to account for future return of products sold in the current period. The reserve will be
reviewed quarterly and will be estimated based on an analysis of our historical experience related to product returns.
29
Grant Revenues
Grant revenue recognition is based on the terms of the grant. The Company generally receives two kinds of grants: cost
reimbursement-based grants, and fixed price grants for which payments are due upon the achievement of specific milestones. For cost
reimbursement-based grants, revenues are based upon internal and subcontractor costs incurred that are specifically covered by the
grants, and where applicable, an additional facilities and administrative rate that provides funding for overhead expenses. These
revenues are recognized as grant-related expenses are incurred by the Company or its subcontractors. Fixed price grants that provide
for payments upon the completion of specific milestones are considered revenue arrangements with multiple deliverables, and as such,
revenue is allocated among the accounting units as described above and is recognized only as elements are delivered and the Company
determines there are no uncertainties regarding customer acceptance.
Derivative Financial Instruments
The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks.
The Company reviews the terms of convertible debt and equity instruments it issues to determine whether there are derivative
instruments, including an embedded conversion option that is required to be bifurcated and accounted for separately as a derivative
financial instrument. In circumstances where the convertible instrument contains more than one embedded derivative instrument,
including the conversion option, that is required to be bifurcated, the bifurcated derivative instruments are accounted for as a single,
compound derivative instrument. Also, in connection with the sale of convertible debt and equity instruments, the Company may issue
freestanding warrants that may, depending on their terms, be accounted for as derivative instrument liabilities, rather than as equity.
Derivative instruments are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value
reported as non-operating income or expense. When the convertible debt or equity instruments contain embedded derivative
instruments that are to be bifurcated and accounted for as liabilities, the total proceeds allocated to the convertible host instruments are
first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the
convertible instruments themselves, usually resulting in those instruments being recorded at a discount from their face value.
Fair Value Measurements
Financial assets and liabilities are measured at fair value, which is defined as the exchange price that would be received for an asset or
paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of
observable inputs and minimize the use of unobservable inputs. The following is a fair value hierarchy based on three levels of inputs,
of which the first two are considered observable and the last unobservable, that may be used to measure fair value:
•
•
•
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar
assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated
by observable market data for substantially the full term of the assets or liabilities.
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value
of the assets or liabilities.
The Company has issued warrants, of which some are classified as derivative liabilities as a result of the terms in the warrants that
provide for down-round protection in the event of a dilutive issuance. The Company uses Level 3 inputs for its valuation methodology
for the warrant derivative liabilities. The estimated fair values were determined using a Monte Carlo option pricing model based on
various assumptions. The Company’s derivative liabilities are adjusted to reflect estimated fair value at each period end, with any
decrease or increase in the estimated fair value being recorded in other income or expense accordingly, as adjustments to fair value of
derivative liabilities. Various factors are considered in the pricing models we use to value the warrants, including the Company’s
current stock price, the remaining life of the warrants, the volatility of the Company’s stock price, and the risk free interest rate. Future
changes in these factors may have an impact on the computed fair value of the warrant liability.
Stock-Based Compensation
For purposes of calculating stock-based compensation, we estimate the fair value of stock options using a Black-Scholes option-
pricing model. The determination of the fair value of share-based payment awards utilizing the Black-Scholes model is affected by our
stock price and a number of assumptions, including expected volatility, expected life, risk-free interest rate and expected dividends.
The expected volatility is based on the historical volatility of our common stock over the most recent period commensurate with the
estimated expected term of the stock options. The expected life of the stock options is based on historical and other economic data
30
trended into the future. The risk-free interest rate assumption is based on observed interest rates appropriate for the expected terms of
our stock options. The dividend yield assumption is based on our history and expectation of no dividend payouts. If factors change and
we employ different assumptions, stock-based compensation expense may differ significantly from what we have recorded in the past.
If there is a difference between the assumptions used in determining stock-based compensation expense and the actual factors that
become known over time, specifically with respect to anticipated forfeitures, we may change the input factors used in determining
stock-based compensation costs for future grants. These changes, if any, may materially impact our results of operations in the period
such changes are made.
Results of Operations
Overview
Organovo was founded in Delaware in April 2007. Activities since the Company’s inception have been devoted primarily to
developing a platform technology and functional human tissues that can be employed in drug discovery and development, biological
research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs, raising capital and building
infrastructure. In November 2014, the Company announced the full commercial release of its first product, the exVive3DTM Human
Liver Tissue for use in toxicology and other preclinical drug testing. In September 2015, we established another wholly-owned
subsidiary in the United Kingdom, Organovo U.K., Ltd., primarily for the purpose of establishing a sales presence in Europe. In
January 2016, we announced that our wholly-owned subsidiary, Samsara, commenced operations. We formed Samsara to serve as a
key source of certain primary human cells that we utilize in our products and services and in the development of therapeutic products.
As of March 31, 2016, the Company has not yet realized significant revenues from its planned principal operations. The Company’s
activities are subject to significant risks and uncertainties including failing to secure additional funding to fully operationalize the
Company’s current technology and continue to implement its business plan.
Comparison of the Years Ended March 31, 2016 and March 31, 2015
Revenues
Revenues of $1.5 million for the year ended March 31, 2016 increased approximately $0.9 million, or 150%, over revenues of $0.6
million for the year ended March 31, 2015. This change reflects an increase of $0.5 million in product and service revenue over the
year ended March 31, 2015, due to an increasing number of customer contracts for our exVive3D Human Liver Tissue during the year
ended March 31, 2016. In addition, collaboration revenue increased $0.3 million due to two new collaborative research agreements
that began during the fiscal year ended March 31, 2016, and grant revenue increased $0.1 million due to activities under an NIH grant
that was ongoing during the first half of fiscal 2016.
Operating Expenses
Operating expenses increased approximately $9.2 million, or 30%, from $30.9 million for the year ended March 31, 2015 to $40.1
million for the year ended March 31, 2016. Of this increase, approximately $4.1 million is related to increased selling, general and
administrative expense, while the other $5.1 million relates to increased investment in research and development expense. These
increases are attributed to the Company’s continued implementation of its business plan, including hiring additional staff to support
research and development initiatives, incremental investments associated with strategic growth and commercialization initiatives
following the commercial launch of our exVive3D Human Liver Tissue in November 2014, expenses related to operating as a publicly
traded corporation, and expansion of its facility.
Research and Development Expenses
Research and development expense increased $5.1 million, or 40%, from approximately $12.9 million for the year ended March 31,
2015 to approximately $18.0 million for the year ended March 31, 2016 as the Company significantly increased its research staff to
support its obligations under certain collaborative research agreements and grants, to complete additional research studies for its liver
product and to expand its kidney product development team. Full-time research and development staffing increased from an average
of forty-four full-time employees during the year ended March 31, 2015 to an average of sixty-eight full-time employees during the
year ended March 31, 2016, resulting in increases in staffing expense of approximately $2.6 million, facility costs of approximately
$1.2 million, lab supply costs of approximately $1.0 million, and outsourced research and consulting related to new product
development of approximately $0.3 million.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased approximately $4.1 million, or 23%, from $18.0 million for the year ended
March 31, 2015 to approximately $22.1 million for the year ended March 31, 2016. This increase was primarily driven by an increase
in staffing-related expenses of approximately $2.3 million due to the headcount increase from an average of sixteen full-time
31
employees during the year ended March 31, 2015 to an average of twenty-eight full-time employees during the year ended March 31,
2016, to support the commercial launch of our exVive3D Human Liver Tissue and to provide strategic infrastructure in developing
collaborative relationships and the commercialization of research-derived product introductions. Non-cash stock-based compensation
costs also increased approximately $1.5 million, $1.3 million of which is related to the acceleration of vesting and modification to
extend the exercise period for an employee who terminated employment due to disability (as defined in the Company’s Amended and
Restated 2012 Equity Plan) in addition to new grants during the period. In addition, due to the Company’s overall growth and
expansion of the commercial business during the year ended March 31, 2016, strategic consulting and facility-related costs increased
significantly over the previous year. Partially mitigating these increases was a $0.8 million decrease in expense related to vendor
warrants due to fewer warrants issued and outstanding as well as the reversal of approximately $0.1 million of expense related to a
potential bonus equity issuance to a consultant during the year ended March 31, 2016.
Other Income (Expense)
Other income was approximately $0.1 million for the year ended March 31, 2016, and consisted primarily of interest income. For the
year ended March 31, 2015, other income of approximately $0.2 million consisted primarily of gains related to the revaluation of
warrant derivative liabilities, and to a lesser extent, interest income. As a result of fewer outstanding warrants underlying the
derivative liabilities in fiscal 2016, changes in fair value have had a lesser impact on other income (expense).
Comparison of the Years Ended March 31, 2015 and March 31, 2014
Revenues
Revenues of $0.6 million for the year ended March 31, 2015 increased approximately $0.2 million, or 50%, over revenues of $0.4
million for the year ended March 31, 2014. This increase reflects the recognition of $0.3 million in commercial revenue since the
Company’s product launch in November 2014, partially offset by a $0.1 million decrease in collaboration revenue due to the
completion of one of the Company’s larger collaborative research agreements during the year ended March 31, 2014.
Operating Expenses
Operating expenses increased approximately $9.9 million, or 47%, from $21.0 million for the year ended March 31, 2014 to $30.9
million for the year ended March 31, 2015. Of this increase, approximately $5.0 million is related to increased selling, general and
administrative expense, while the other $4.9 million relates to increased investment in research and development expense. Those
increases are attributed to the Company’s continued implementation of its business plan, including hiring additional staff to support its
research and development initiatives, incremental investment associated with commercialization project initiatives, expenses related to
operating as a publicly traded corporation, expansion to a larger facility, and increased stock compensation expense relative to
employees and certain consulting services.
Research and Development Expenses
Research and development expense increased $4.9 million, or 61%, from approximately $8.0 million for the year ended March 31,
2014 to approximately $12.9 million for the year ended March 31, 2015 as the Company significantly increased its research staff to
support its obligations under certain collaborative research agreements and grants, and to expand product development efforts in
preparation for commercial revenues. Full-time research and development staffing increased from an average of twenty-five full-time
employees for the year ended March 31, 2014 to an average of forty-four full-time employees for the year ended March 31, 2015. In
addition to the incremental payroll, benefits and stock-based compensation resulting from increased staffing levels, the Company
increased its facility space to accommodate its growing research staff, and increased its spending on lab equipment and supplies in
proportion to its increased research activities.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased approximately $5.0 million, or 38%, from $13.0 million for the year ended
March 31, 2014 to approximately $18.0 million for the year ended March 31, 2015. Increased staffing expenses of approximately $1.0
million was due to the headcount increase from an average of twelve full-time employees for the year ended March 31, 2014 to an
average of sixteen full-time employees as of March 31, 2015, to provide strategic infrastructure in developing collaborative
relationships and preparing for commercialization of products and services, and to address the additional compliance requirements of
operating as a publicly traded corporation. Stock-based compensation costs also increased approximately $1.7 million due to
additional grants to employees and consultants. In addition, due to the Company’s overall growth and transition into the commercial
phase during the year ended March 31, 2015, fees for legal services, investor outreach, marketing, insurance and consulting increased
over the previous year. Finally, facility costs increased due the expansion of the Company’s facility during the latter part of the year
ended March 31, 2014.
32
Other Income (Expense)
Other income was approximately $0.2 million for the year ended March 31, 2015, and consisted primarily of interest income and a
gain related to the revaluation of warrant derivative liabilities. This gain was caused by a declining stock price during the period that
decreased the value of the derivative liability. For the year ended March 31, 2014, other expense consisted primarily of a $5.1 million
loss related to the revaluation of warrant derivative liabilities due to rising stock prices during the period that caused an increase in the
value of the derivative liability. In addition, the majority of the underlying warrants to which the derivative relates were exercised or
converted to equity instruments during fiscal 2014, significantly lessening the impact of subsequent changes in our stock price.
Various factors are considered in the pricing models we use to value the warrants, including the Company’s current stock price, the
remaining life of the warrants, the volatility of the Company’s stock price, and the risk free interest rate. Future changes in these
factors may have a significant impact on the computed fair value of the warrant liability. As such, we expect future changes in the fair
value of the warrants could continue to vary significantly from period to period.
Financial Condition, Liquidity and Capital Resources
The Company has primarily devoted its efforts to technology and product development, raising capital and building infrastructure. In
November 2014, the Company announced the full commercial release of its first product, the exVive3D Human Liver Tissue for use in
toxicology and other preclinical drug testing, and has built a sales and marketing and research and development infrastructure to
support the commercialization of research services of the exVive3D Human Liver Tissue.
The Company has incurred negative cash flows from operations. Net cash used in operations is primarily driven by our operating
results (net income adjusted for stock-based compensation, depreciation, amortization, changes in fair value, and other non-cash
charges). As of March 31, 2016, the Company had cash and cash equivalents of $62.1 million and an accumulated deficit of $160.9
million. The Company also had negative cash flows from operations of $29.4 million, $19.6 million, and $15.6 million for the years
ended March 31, 2016, 2015 and 2014, respectively.
At March 31, 2016, we had total current assets of $63.7 million and current liabilities of $4.5 million, resulting in working capital of
$59.2 million. At March 31, 2015, we had total current assets of $51.3 million and current liabilities of $4.8 million, resulting in
working capital of $46.5 million.
Net cash used in investing activities was approximately $2.1 million, $1.5 million, and $0.3 million for the years ended March 31,
2016, 2015 and 2014, respectively. The majority of net cash used in investing activities to date has been for capital purchases,
including laboratory equipment purchases and the expansion and buildout of the Company’s facilities related to its expanded research
capabilities and the commercialization of its first product.
Net cash provided by financing activities was approximately $43.5 million, $23.1 million, and $48.4 million for the years ended
March 31, 2016, 2015 and 2014, respectively.
During the year ended March 31, 2016, we raised net proceeds of approximately $43.1 million through the sale of 10,838,750 shares
of our common stock. In addition, we raised approximately $0.3 million from stock option exercises during the year ended March 31,
2016.
During the year ended March 31, 2015, we raised net proceeds of approximately $22.3 million through the sale of 3,197,768 shares of
our common stock through at-the-market offerings. In addition, we raised approximately $0.4 million from the exercise of warrants,
and $0.4 million from stock option exercises during the year ended March 31, 2015.
Through March 31, 2016, the Company has financed its operations primarily through the sale of convertible notes, the private
placement of equity securities, the sale of common stock through public offerings, and from revenue derived from products and
research-based services, grants, and collaborative research agreements. Based on its current operating plan and available cash
resources, the Company has sufficient resources to fund its business for at least the next twelve months.
The Company will need additional capital to further fund the development and commercialization of its human tissues that can be
employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or
degenerating tissues and organs. The Company intends to cover its future operating expenses through cash on hand, through revenue
derived from research services agreements, product sales, grants, and collaborative research agreements, and through the issuance of
additional equity or debt securities. Depending on market conditions, we cannot be sure that additional financing will be available
when needed or that, if available, financing will be obtained on terms favorable to us or our stockholders.
33
Having insufficient funds may require us to delay, scale back, or eliminate some or all of our development programs or relinquish
rights to our technology on less favorable terms than we would otherwise choose. Failure to obtain adequate financing could
eventually adversely affect our ability to operate as a going concern. If we raise additional funds from the issuance of equity securities,
substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms
of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our
ability to operate our business.
Contractual Obligations
In the normal course of business, we enter into contracts and commitments that obligate us to make payments in the future. The table
below sets forth Organovo’s significant contractual obligations and related scheduled payments as of March 31, 2016 (in thousands):
Operating lease obligations (A)
Total
Total
2017
2018 to
2019
2020 to
2021
2022 and
Thereafter
$
$
6,148 $
6,148 $
1,313 $
1,313 $
2,192
2,192
$
$
2,176 $
2,176 $
467
467
(A) Operating lease obligations include the remaining payments due under the Company’s facility leases.
Recent Accounting Pronouncements
For information regarding recently adopted and issued accounting pronouncements, see Note 11 to the consolidated financial
statements.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
The primary objective of our investment activities is to preserve our capital for the purpose of funding our operations. To achieve
these objectives, our investment policy allows us to maintain a portfolio of cash, cash equivalents, and short-term investments in a
variety of securities, including money market funds. Our primary exposure to market risk is interest income sensitivity, which is
affected by changes in the general level of U.S. interest rates, particularly because the majority of our investments are comprised of
cash and cash equivalents. We currently do not hedge interest rate exposure. Due to the nature of our short-term investments, we
believe that we are not subject to any material market risk exposure. We have limited foreign currency risk exposure as our business
operates primarily in U.S. dollars. We do not have any foreign currency or other derivative financial instruments.
34
Item 8. Consolidated Financial Statements.
Organovo Holdings, Inc.
Index to Consolidated Financial Statements
Reports of Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of March 31, 2016 and March 31, 2015
Consolidated Statements of Operations for the years ended March 31, 2016, 2015 and 2014
Consolidated Statements of Stockholders’ Equity from March 31, 2013 through March 31, 2016
Consolidated Statements of Cash Flows for the years ended March 31, 2016, 2015 and 2014
..
Notes to Consolidated Financial Statements
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F-2
F-4
F-5
F-6
F-7
F-9
Page
Number
F-1
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of
Organovo Holdings, Inc.
San Diego, California
We have audited the accompanying consolidated balance sheets of Organovo Holdings, Inc. and Subsidiaries (the “Company”) as
of March 31, 2016 and 2015, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of
the years in the three year period ended March 31, 2016. 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. 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 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 financial position of
Organovo Holdings, Inc. and Subsidiaries as of March 31, 2016 and 2015, and the results of their consolidated operations and their
cash flows for each of the three years in the period ended March 31, 2016, in conformity with accounting principles generally
accepted in the United States of America.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the
effectiveness of Organovo Holdings, Inc. and Subsidiaries’ internal control over financial reporting as of March 31, 2016, based on
criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO), and our report dated June 9, 2016 expressed an unqualified opinion.
/s/ Mayer Hoffman McCann P.C.
San Diego, CA
June 9, 2016
F-2
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of
Organovo Holdings, Inc.
San Diego, California
We have audited Organovo Holdings, Inc. and Subsidiaries’ internal control over financial reporting as of March 31, 2016, based
on criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO). Organovo Holdings, Inc. and Subsidiaries’ management is responsible for maintaining effective
internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included
in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an
opinion on the company’s internal control over financial reporting 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 effective internal control over
financial reporting was maintained in all material respects. Our audit of internal control over financial reporting included obtaining an
understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating
the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other
procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the
maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in
accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect
on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections
of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in
conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In our opinion, Organovo Holdings, Inc. and Subsidiaries maintained, in all material respects, effective internal control over
financial reporting as of March 31, 2016, based on criteria established in Internal Control—Integrated Framework (2013) issued by
the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the
consolidated balance sheets and the related consolidated statements of operations, stockholders’ equity, and cash flows of Organovo
Holdings, Inc. and Subsidiaries, and our report dated June 9, 2016 expressed an unqualified opinion.
/s/ Mayer Hoffman McCann P.C.
San Diego, CA
June 9, 2016
F-3
ORGANOVO HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands except per share data)
Assets
Current Assets
Cash and cash equivalents
Accounts receivable
Inventory, net
Prepaid expenses and other current assets
Total current assets
Fixed assets, net
Restricted cash
Other assets, net
Total assets
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable
Accrued expenses
Deferred rent
Deferred revenue
Capital lease obligation
Warrant liabilities
Total current liabilities
Deferred revenue, net of current portion
Deferred rent, net of current portion
Total liabilities
Commitments and Contingencies (Note 6)
Stockholders’ Equity
Common stock, $0.001 par value; 150,000,000 shares authorized,
92,391,989 and 81,536,724 shares issued and outstanding at
March 31, 2016 and March 31, 2015, respectively
Additional paid-in capital
Accumulated deficit
Total stockholders’ equity
Total Liabilities and Stockholders’ Equity
March 31, 2016
March 31, 2015
$
$
$
$
$
62,091 $
259
334
968
63,652
3,711
79
134
67,576 $
787 $
2,450
139
1,110
—
4
4,490
—
905
5,395 $
50,142
—
66
1,054
51,262
2,042
79
106
53,489
1,387
2,257
759
227
5
126
4,761
32
—
4,793
92
222,959
(160,870 )
62,181
67,576 $
82
170,909
(122,295)
48,696
53,489
The accompanying notes are an integral part of these consolidated financial statements.
F-4
ORGANOVO HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except per share data)
Revenues
Product and service
Collaborations
Grants
Total Revenues
Selling, general, and administrative expenses
Research and development expenses
Loss from Operations
Other Income (Expense)
Change in fair value of warrant liabilities
Loss on disposal of fixed assets
Interest expense
Interest income
Total Other Income (Expense)
Income Tax Expense
Net Loss
Net loss per common share—basic and diluted
Weighted average shares used in computing net
loss per common share—basic and diluted
Year Ended
March 31,
2016
Year Ended
March 31,
2015
Year Ended
March 31,
2014
$
$
$
806 $
486
191
1,483
22,118
18,008
(38,643)
(17)
—
—
88
71
(3)
(38,575) $
(0.43) $
314 $
134
123
571
17,947
12,921
(30,297 )
196
(12 )
(1 )
32
215
—
(30,082 ) $
(0.38 ) $
—
248
131
379
13,054
7,974
(20,649)
(5,120)
(84)
(13)
18
(5,199)
—
(25,848)
(0.35)
90,057,356
79,650,087
73,139,618
The accompanying notes are an integral part of these consolidated financial statements.
F-5
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (in thousands)
ORGANOVO HOLDINGS, INC.
Additional
Balance at March 31, 2013
Issuance of common stock from warrant exercises, net
Issuance of restricted common stock
Restricted stock forfeitures
Issuance of common stock from public offering, net
Stock-based compensation expense
Expense related to modification of warrants
Warrant liability removed due to exercises of warrants
Warrant liability reclassified to equity
Stock option exercises
Issuance of warrants to consultant
Net loss
Balance at March 31, 2014
Issuance of common stock from warrant exercises, net
Restricted stock forfeitures
Issuance of common stock from public offering, net
Stock-based compensation expense
Warrant liability removed due to exercises of warrants
Stock option exercises
Issuance of warrants to consultant
Net loss
Balance at March 31, 2015
Issuance of common stock from warrant exercises, net
Restricted stock forfeitures
Issuance of common stock from public offering, net
Stock-based compensation expense
Warrant liability removed due to exercises of warrants
Stock option exercises
Issuance of warrants to consultant
Adjustment related to potential equity bonus issuance
Net loss
Balance at March 31, 2016
Common Stock
Shares
Amount
64,687 $
2,713
60
(215)
10,684
—
—
—
—
184
—
—
78,113 $
211
(190)
3,198
—
—
205
—
—
81,537 $
32
(132)
10,839
—
—
116
—
—
—
92,392 $
65 $
3
—
—
10
—
—
—
—
—
—
—
78 $
—
—
4
—
—
—
—
—
82 $
—
—
10
—
—
—
—
—
—
92 $
Paid-in
Capital
Accumulated
75,269 $
1,098
—
—
46,905
4,600
12
10,874
767
402
492
—
140,419 $
445
—
22,303
7,020
55
351
316
—
Deficit
(66,365) $
—
—
—
—
—
—
—
—
—
—
(25,848)
(92,213) $
—
—
—
—
—
—
—
(30,082)
170,909 $ (122,295) $
—
—
—
—
—
—
—
—
(38,575)
222,959 $ (160,870) $
—
—
43,127
8,556
139
320
38
(130 )
—
Total
8,969
1,101
—
—
46,915
4,600
12
10,874
767
402
492
(25,848)
48,284
445
—
22,307
7,020
55
351
316
(30,082)
48,696
—
—
43,137
8,556
139
320
38
(130)
(38,575)
62,181
The accompanying notes are an integral part of these consolidated financial statements.
F-6
ORGANOVO HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands)
Year Ended
March 31, 2016
Year Ended
March 31, 2015
Year Ended
March 31, 2014
$
(38,575) $
(30,082 ) $
(25,848)
Cash Flows From Operating Activities
Net loss
Adjustments to reconcile net loss to net cash used
in operating activities:
Amortization of warrants issued for services
Depreciation and amortization
Loss on disposal of fixed assets
Change in fair value of warrant liabilities
Expense associated with warrant modification
Stock-based compensation
Increase (decrease) in cash resulting from changes in:
Grants receivable
Accounts receivable
Inventory
Prepaid expenses and other assets
Accounts payable
Accrued expenses
Deferred rent
Deferred revenue
Net cash used in operating activities
Cash Flows From Investing Activities
Deposits released from restriction
Purchases of fixed assets
Proceeds from disposals of fixed assets
Purchases of intangible assets
Net cash used in investing activities
Cash Flows From Financing Activities
Proceeds from issuance of common stock and
exercise of warrants, net
Proceeds from exercise of stock options
Principal payments on capital lease obligations
Deferred financing costs
Net cash provided by financing activities
Net Increase in Cash and Cash Equivalents
Cash and Cash Equivalents at Beginning of Period
Cash and Cash Equivalents at End of Period
Supplemental Disclosure of Cash Flow Information:
Interest
Income Taxes
$
$
$
(92)
815
—
17
—
8,556
—
(259)
(268)
83
(600)
193
(89)
851
(29,368)
—
(2,114)
14
(35)
(2,135)
43,137
320
(5)
—
43,452
11,949
50,142
62,091 $
— $
3 $
557
472
12
(196 )
—
7,020
—
—
(3 )
(389 )
1,061
1,435
270
242
(19,601 )
—
(1,517 )
—
—
(1,517 )
22,752
351
(10 )
—
23,093
1,975
48,167
50,142 $
— $
4 $
323
387
84
5,120
12
4,600
101
—
25
(392)
(315)
312
75
(45)
(15,561)
9
(277)
—
—
(268)
48,016
402
(10)
(40)
48,368
32,539
15,628
48,167
—
—
The accompanying notes are an integral part of these consolidated financial statements.
F-7
Supplemental Disclosure of Noncash Investing and Financing Activities ($ in thousands):
During the year ended March 31, 2014, the warrant liability was reduced by approximately $10,874 as a result of warrant exercises.
During the year ended March 31, 2014, the warrant liability was reduced by approximately $767 for warrants reclassified as equity
instruments.
During the year ended March 31, 2014, the Company issued 75,000 warrants to purchase shares of our common stock for consulting
services. The warrants were valued at approximately $404.
During the year ended March 31, 2015, the warrant liability was reduced by approximately $55 as a result of warrant exercises.
During the year ended March 31, 2015, approximately $144 of leasehold improvements were funded by the Company’s landlord as a
lease incentive. The Company capitalized these costs as property, plant and equipment, with a corresponding increase in deferred rent
that will be amortized over the remaining lease term.
During the year ended March 31, 2016, the warrant liability was reduced by approximately $139 as a result of warrant exercises.
During the year ended March 31, 2016, approximately $374 of leasehold improvements were funded by the Company’s landlord as a
lease incentive. The Company capitalized these costs as property, plant and equipment, with a corresponding increase in deferred rent
that will be amortized over the remaining lease term.
The accompanying notes are an integral part of these consolidated financial statements.
F-8
Organovo Holdings, Inc.
Notes to Consolidated Financial Statements
1. Description of Business and Summary of Significant Accounting Policies
A summary of significant accounting policies, consistently applied in the preparation of the accompanying consolidated financial
statements follows:
Nature of operations and basis of presentation
References in these notes to the consolidated financial statements to “Organovo Holdings, Inc.,” “Organovo Holdings,” “we,” “us,”
“our,” “the Company” and “our Company” refer to Organovo Holdings, Inc. and its consolidated subsidiaries. Our consolidated
financial statements include the accounts of the Company as well as its wholly-owned subsidiaries, with all material intercompany
accounts and transactions eliminated in consolidation. In December 2014, we established a wholly-owned subsidiary, Samsara
Sciences, Inc., to focus on the acquisition of qualified cells in support of our commercial and research endeavors. In September 2015,
we established another wholly-owned subsidiary in the United Kingdom, Organovo U.K., Ltd., for the primary purpose of establishing
a sales presence in Europe.
Since its inception, the Company has devoted its efforts primarily to developing and commercializing a platform technology and
functional human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for
the treatment of damaged or degenerating tissues and organs. The Company has also focused on raising capital and building
infrastructure. In November 2014, the Company announced the commercial release of its first product, the exVive3D™ Human Liver
Tissue for use in toxicology and other preclinical drug testing. As of March 31, 2016, the Company had not yet realized significant
revenues from its planned principal operations. The Company’s activities are subject to significant risks and uncertainties including
failing to successfully develop products and services based on its technology and to achieve the market acceptance necessary to
generate sufficient revenues and to achieve and sustain profitability.
NYSE MKT listing
On July 9, 2013, the Company announced that its common stock had been approved to list on the NYSE MKT. Shares began trading
on the New York Stock Exchange on July 11, 2013 under the symbol “ONVO”. Prior to that time, the Company’s shares were quoted
on the OTC QX.
Liquidity
As of March 31, 2016, the Company had an accumulated deficit of approximately $160.9 million. The Company also had negative
cash flows from operations of approximately $29.4 million during the year ended March 31, 2016.
Through March 31, 2016, the Company has financed its operations primarily through the sale of convertible notes, the private
placement of equity securities, the sale of common stock through public offerings, and through revenue derived from grants,
collaborative research agreements, and product and research service-based agreements. Based on its current operating plan and
available cash resources, the Company believes it has sufficient resources to fund its business for at least the next twelve months.
The Company will need additional capital to further fund the development and commercialization of its human tissues that can be
employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or
degenerating tissues and organs. The Company intends to cover its future operating expenses through cash on hand, through revenue
derived from research service agreements, product sales, collaborative research agreements, grants, and through the issuance of
additional equity or debt securities. Depending on market conditions, we cannot be sure that additional financing will be available
when needed or that, if available, financing will be obtained on terms favorable to us or to our stockholders.
Having insufficient funds may require us to delay, scale back, or eliminate some or all of our development programs or relinquish
rights to our technology on less favorable terms than we would otherwise choose. Failure to obtain adequate financing could
eventually adversely affect our ability to operate as a going concern. If we raise additional funds from the issuance of equity securities,
substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms
of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our
ability to operate our business.
F-9
Use of estimates
The preparation of the financial statements in conformity with accounting principles generally accepted in the United States requires
management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could
differ from those estimates. Significant estimates used in preparing the consolidated financial statements include those assumed in
computing the valuation of warrants, revenue recognized under the proportional performance model, the valuation of stock-based
compensation expense, and the valuation allowance on deferred tax assets.
Financial instruments
For certain of the Company’s financial instruments, including cash and cash equivalents, inventory, prepaid expenses and other assets,
accounts payable, accrued expenses, deferred revenue, and capital lease obligations, the carrying amounts are generally considered to
be representative of their respective fair values because of the short-term nature of those instruments.
Cash and cash equivalents
The Company considers all highly liquid investments with original maturities of 90 days or less to be cash equivalents.
Derivative financial instruments
The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency.
The Company reviews the terms of convertible debt and equity instruments it issues to determine whether there are derivative
instruments, including an embedded conversion option that is required to be bifurcated and accounted for separately as a derivative
financial instrument. In circumstances where a host instrument contains more than one embedded derivative instrument, including a
conversion option, that is required to be bifurcated, the bifurcated derivative instruments are accounted for as a single, compound
derivative instrument. Also, in connection with the sale of convertible debt and equity instruments, the Company may issue
freestanding warrants that may, depending on their terms, be accounted for as derivative instrument liabilities, rather than as equity.
Derivative instruments are initially recorded at fair value and are then revalued at each reporting date with changes in the fair value
reported as non-operating income or expense. When the convertible debt or equity instruments contain embedded derivative
instruments that are to be bifurcated and accounted for as liabilities, the total proceeds allocated to the convertible host instruments are
first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the
convertible instruments themselves, usually resulting in those instruments being recorded at a discount from their face value.
The discount from the face value of the convertible debt, together with the stated interest on the instrument, is amortized over the life
of the instrument through periodic charges to interest expense, using the effective interest method.
Restricted cash
As of March 31, 2016 and 2015, the Company had approximately $79,000 of restricted cash deposited with a financial institution. The
entire amount is held in certificates of deposit to support a letter of credit agreement related to the Company’s facility lease.
Inventory
Inventories are stated at the lower of the cost or market (first-in, first-out). Inventory at March 31, 2016 consists of approximately
$206,000 in raw materials, approximately $15,000 in work-in-process inventory, and approximately $113,000 in finished goods.
Inventory at March 31, 2015 consisted of approximately $66,000 in raw materials, net of reserves.
Fixed assets and depreciation
Property and equipment are carried at cost. Expenditures that extend the life of the asset are capitalized and depreciated. Depreciation
and amortization are provided using the straight-line method over the estimated useful lives of the related assets or, in the case of
leasehold improvements, over the lesser of the useful life of the related asset or the remaining lease term. The estimated useful lives of
the fixed assets range between one and seven years.
Impairment of long-lived assets
In accordance with authoritative guidance the Company reviews its long-lived assets, including property and equipment and other
assets, for impairment whenever events or changes in circumstances indicate that the carrying amounts of the assets may not be fully
F-10
recoverable. To determine recoverability of its long-lived assets, the Company evaluates whether future undiscounted net cash flows
will be less than the carrying amount of the assets and adjusts the carrying amount of its assets to fair value. Management has
determined that no impairment of long-lived assets occurred as of March 31, 2016.
Fair value measurement
Financial assets and liabilities are measured at fair value, which is defined as the exchange price that would be received for an asset or
paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of
observable inputs and minimize the use of unobservable inputs. The following is a fair value hierarchy based on three levels of inputs,
of which the first two are considered observable and the last unobservable, that may be used to measure fair value:
•
•
•
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar
assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated
by observable market data for substantially the full term of the assets or liabilities.
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value
of the assets or liabilities.
The Company has issued warrants, of which some are classified as derivative liabilities as a result of the terms in the warrants that
provide for down-round protection in the event of a dilutive issuance. The Company uses Level 3 inputs for its valuation methodology
for the warrant derivative liabilities. The estimated fair values were determined using a Monte Carlo option pricing model based on
various assumptions (see Note 4). The Company’s derivative liabilities are adjusted to reflect estimated fair value at each period end,
with any decrease or increase in the estimated fair value being recorded in other income or expense accordingly, as adjustments to the
fair value of derivative liabilities. Various factors are considered in the pricing models we use to value the warrants, including the
Company’s current stock price, the remaining life of the warrants, the volatility of the Company’s stock price, and the risk free interest
rate. Future changes in these factors may have an impact on the computed fair value of the warrant liability.
The estimated fair values of the liabilities measured on a recurring basis are as follows:
Fair Value Measurements at March 31, 2016 and 2015 (in thousands):
Significant
Other
Unobservable
Inputs
(Level 3)
Significant
Other
Observable
Inputs
(Level 2)
Quoted
Prices in
Active
Markets
(Level 1)
Balance at
March 31,
2016
Warrant liability
Warrant liability
$
$
4 $
—
$
— $
4
Balance at
March 31,
2015
Quoted
Prices in
Active
Markets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Other
Unobservable
Inputs
(Level 3)
126 $
—
$
— $
126
F-11
The following table presents the activity for liabilities measured at estimated fair value using unobservable inputs for the years ended
March 31, 2016 and 2015:
Fair Value Measurements Using Significant Unobservable Inputs (Level 3)
Balance at March 31, 2014
Issuances
Adjustments to estimated fair value
Warrant liability removal due to settlements
Balance at March 31, 2015
Issuances
Adjustments to estimated fair value
Warrant liability removal due to settlements
Balance at March 31, 2016
Research and development
Warrant
Derivative
Liability
(in thousands)
377
—
(196)
(55)
126
—
17
(139)
4
$
$
$
$
$
$
$
$
$
Research and development expenses, including direct and allocated expenses, consist of independent research and development costs,
as well as costs associated with sponsored research and development. Research and development costs are expensed as incurred.
Income taxes
Deferred income taxes are recognized for the tax consequences in future years for differences between the tax basis of assets and
liabilities and their financial reporting amounts at each year end based on enacted tax laws and statutory tax rates applicable to the
periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce
deferred tax assets to the amount expected to be realized. Income tax expense is the combination of the tax payable for the year and
the change during the year in deferred tax assets and liabilities.
Revenue recognition
The Company’s revenues are derived from research service agreements, product sales, collaborative research agreements, and grants
from the National Institutes of Health (“NIH”), U.S. Treasury Department and private not-for-profit organizations.
The Company recognizes revenue when the following criteria have been met: (i) persuasive evidence of an arrangement exists; (ii)
services have been rendered or product has been delivered; (iii) price to the customer is fixed and determinable; and (iv) collection of
the underlying receivable is reasonably assured.
Billings to customers or payments received from customers are included in deferred revenue on the balance sheet until all revenue
recognition criteria are met. As of March 31, 2016 and 2015, the Company had approximately $1,110,000 and $259,000, respectively,
in deferred revenue related to its commercial products and research service agreements, grants, and collaborative research programs.
Revenue arrangements with multiple deliverables
The Company follows ASC 605-25 Revenue Recognition – Multiple-Element Arrangements for revenue arrangements that contain
multiple deliverables. Judgment is required to properly identify the accounting units of the multiple deliverable transactions and to
determine the manner in which revenue should be allocated among the accounting units. Moreover, judgment is used in interpreting
the commercial terms and determining when all criteria of revenue recognition have been met for each deliverable in order for revenue
recognition to occur in the appropriate accounting period. For multiple deliverable agreements, consideration is allocated at the
inception of the agreement to all deliverables based on their relative selling price. The relative selling price for each deliverable is
determined using vendor-specific objective evidence (“VSOE”) of selling price or third-party evidence of selling price if VSOE does
not exist. If neither VSOE nor third-party evidence of selling price exists, the Company uses its best estimate of the selling price for
the deliverable.
F-12
While changes in the allocation of the arrangement consideration between the units of accounting will not affect the amount of total
revenue recognized for a particular sales arrangement, any material changes in these allocations could impact the timing of revenue
recognition, which could affect the Company’s results of operations.
The Company periodically receives license fees for non-exclusive research licensing associated with funded research projects. License
fees under these arrangements are recognized over the term of the contract or development period as it has been determined that such
licenses do not have stand-alone value.
Revenue from research service agreements
For research service agreements that contain only a single or primary deliverable, the Company defers any up-front fees collected
from customers, and recognizes revenue for the delivered element only when it determines there are no uncertainties regarding
customer acceptance. For agreements that contain multiple deliverables, the Company follows ASC 605-25 as described above.
Research and development revenue under collaborative agreements
The Company’s collaboration revenue consists of license and collaboration agreements that contain multiple elements, including non-
refundable up-front fees, payments for reimbursement of third-party research costs, payments for ongoing research, payments
associated with achieving specific development milestones and royalties based on specified percentages of net product sales, if any.
The Company considers a variety of factors in determining the appropriate method of revenue recognition under these arrangements,
such as whether the elements are separable, whether there are determinable fair values and whether there is a unique earnings process
associated with each element of a contract.
The Company recognizes revenue from research funding under collaboration agreements when earned on a “proportional
performance” basis as research services are provided or substantive milestones are achieved. We recognize revenue that is contingent
upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. A milestone is
considered substantive when the consideration payable to us for the milestone (i) is consistent with our performance necessary to
achieve the milestone or the increase in value to the collaboration resulting from our performance, (ii) relates solely to our past
performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. In making this
assessment, we consider all facts and circumstances relevant to the arrangement, including factors such as the risks that must be
overcome to achieve the milestone, the level of effort and investment required to achieve the milestone and whether any portion of the
milestone consideration is related to future performance or deliverables.
The Company initially defers revenue for any amounts billed or payments received in advance of the services being performed, and
recognizes revenue pursuant to the related pattern of performance, using the appropriate method of revenue recognition based on its
analysis of the related contractual element(s).
In 2011, the Company entered into a research collaboration agreement with a third party to perform research and development
services. The agreement, as amended in 2012, was for a total fixed fee of $1,405,000. The Company completed its obligations under
this agreement and recognized the remaining revenue of approximately $184,000 during the year ended March 31, 2014, in
recognition of the proportional performance achieved.
In September 2013, the Company entered into a research contract agreement with a third party to perform research and development
services for fixed fees. The Company completed its obligations under this agreement during the year ended March 31, 2015. The
Company recorded approximately $69,000 and $7,000 for the years ended March 31, 2015 and 2014, respectively, in revenue related
to the research contract in recognition of the proportional performance achieved.
In October 2013, the Company entered into a research contract agreement with a third party to perform research and development
services for fixed fees. The Company completed its obligations under this agreement during the year ended March 31, 2015. The
Company recorded approximately $41,000 and $52,000 for the years ended March 31, 2015 and 2014, respectively, in revenue related
to the research contract in recognition of the proportional performance achieved.
In November 2014, the Company entered into a collaborative nonexclusive research affiliation with a university medical school and a
non-profit medical charity, under which the Company received a one-time grant from the charity towards the placement of a NovoGen
Bioprinter at the university for the purpose of developing bioprinted tissues for surgical transplantation research. The Company has
recorded approximately $50,000 and $18,000 for the years ended March 31, 2016 and 2015, respectively, in revenue related to this
collaboration in recognition of the proportional performance achieved.
F-13
In April 2015, the Company entered into a research collaboration agreement with a third party to develop custom tissue models for
fixed fees. Based on the proportional performance achieved under this agreement for the year ended March 31, 2016, the Company
has recorded approximately $352,000 in collaboration revenue for the year.
Also in April 2015, the Company entered into a multi-year research agreement with a third party to develop multiple custom tissue
models for use in drug development. Approximately $80,000 under this agreement was recognized as revenue in recognition of the
proportional performance achieved during the year ended March 31, 2016.
Product revenue
The Company recognizes product revenue at the time of shipment to the customer, provided all other revenue recognition criteria have
been met. To date, the Company has not recognized significant revenue from commercial product sales.
As our commercial sales increase, we expect to establish a reserve for estimated product returns that will be recorded as a reduction to
revenue. That reserve will be maintained to account for future return of products sold in the current period. The reserve will be
reviewed quarterly and will be estimated based on an analysis of our historical experience related to product returns.
Grant revenues
During August of 2013, the Company was awarded a research grant by a private, not-for-profit organization for up to $251,700,
contingent on go/no-go decisions made by the grantor at the completion of each stage of research as outlined in the grant award.
Revenues from the grant are based upon internal costs incurred that are specifically covered by the grant, plus an additional rate that
provides funding for overhead expenses. Revenue is recognized when the Company incurs expenses that are related to the grant.
Revenue recognized under this grant was approximately $43,000, $49,000 and $119,000 for the years ended March 31, 2016, 2015
and 2014, respectively.
During September of 2014, the NIH awarded the Company a research grant totaling approximately $222,000. The grant provides for
fixed payments based on the achievement of certain milestones. As such, revenue will be recognized upon completion of those
milestones. Revenue recognized under this grant was approximately $148,000 and $74,000 for the years ended March 31, 2016 and
2015, respectively.
Stock-based compensation
The Company accounts for stock-based compensation in accordance with the Financial Accounting Standards Board’s ASC Topic
718, Compensation — Stock Compensation, which establishes accounting for equity instruments exchanged for employee services.
Under such provisions, stock-based compensation cost is measured at the grant date, based on the calculated fair value of the award,
and is recognized as an expense, under the straight-line method, over the employee’s requisite service period (generally the vesting
period of the equity grant).
The Company accounts for equity instruments, including restricted stock or stock options, issued to non-employees in accordance with
authoritative guidance for equity based payments to non-employees. Stock options issued to non-employees are accounted for at their
estimated fair value determined using the Black-Scholes option-pricing model. The fair value of options granted to non-employees is
re-measured as they vest, and the resulting increase in value, if any, is recognized as expense during the period the related services are
rendered. Restricted stock issued to non-employees is accounted for at its estimated fair value as it vests.
Comprehensive income (loss)
Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances
from non-owner sources. The Company is required to record all components of comprehensive income (loss) in the financial
statements in the period in which they are recognized. Net income (loss) and other comprehensive income (loss), including unrealized
gains and losses on investments, are reported, net of their related tax effect, to arrive at comprehensive income (loss). For the years
ended March 31, 2016, 2015 and 2014, the comprehensive loss was equal to the net loss.
Net loss per share
Basic and diluted net loss per share has been computed using the weighted-average number of shares of common stock outstanding
during the period. The weighted-average number of shares used to compute diluted loss per share excludes any assumed exercise of
stock options and warrants, the assumed release of restriction of restricted stock units, and shares subject to repurchase as the effect
F-14
would be anti-dilutive. No dilutive effect was calculated for the years ended March 31, 2016, 2015 and 2014 as the Company reported
a net loss for each respective period and the effect would have been anti-dilutive. Total common stock equivalents that were excluded
from computing diluted net loss per share were approximately 10.7 million, 8.6 million, and 7.7 million for the years ended March 31,
2016, 2015 and 2014, respectively.
2. Fixed Assets
Fixed assets consisted of the following (in thousands):
Laboratory equipment
Construction in process
Computer software and equipment
Furniture and fixtures
Leasehold improvements
Vehicles
Less accumulated depreciation and amortization
March 31,
2016
March 31,
2015
2,799 $
52
488
337
1,832
9
5,517
(1,806 )
3,711 $
1,951
529
274
135
155
—
3,044
(1,002)
2,042
$
$
Depreciation and amortization expense for the years end March 31, 2016, 2015 and 2014 was approximately $805,000, $464,000, and
$380,000, respectively.
3. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
Accrued compensation
Accrued legal and professional fees
Other accrued expenses
4. Derivative Liability
March 31,
2016
March 31,
2015
2,221 $
168
61
2,450 $
1,917
195
145
2,257
$
$
During 2011 and 2012, the Company issued 22,847,182 five-year warrants to purchase the Company’s common stock in connection
with financing transactions. The exercise price of the warrants is protected against down-round financing throughout the term of the
warrants, as described below. Pursuant to ASC 815-15 and ASC 815-40, the fair value of the warrants was recorded as a derivative
liability on the issuance dates.
The Company revalued the warrants as of the end of each reporting period, and the estimated fair value of the outstanding warrant
liabilities was $4,000 and $126,000 as of March 31, 2016 and 2015, respectively. The change in fair value of the derivative liabilities
for the year ended March 31, 2016 was an increase of $17,000. The changes in fair value of the derivative liabilities for the year ended
March 31, 2015 and 2014 were a decrease of $196,000 and an increase of $5,120,000, respectively. These changes are included in
other income (expense) in the statements of operations.
During the years ended March 31, 2016 and 2015, 43,796 and 8,647 warrants that were classified as derivative liabilities were
exercised. The warrants were revalued as of the settlement date, and the change in fair value was recognized to earnings. In addition,
in the year ended March 31, 2014, the Company entered into amendment agreements with certain of the warrant holders, which
removed the down-round pricing protection provision, resulting in 269,657 of these warrants being reclassified from liability
instruments to equity instruments. The Company also recognized a reduction in the warrant liability based on the fair value as of the
settlement date for the warrants exercised and as of the modification date for the warrants that were amended, with a corresponding
increase in additional paid-in capital.
F-15
The derivative liabilities were valued upon issuance of the warrants and at the end of each reporting period using a Monte Carlo
valuation model with the following assumptions:
Closing price per share of common stock
Exercise price per share
Expected volatility
Risk-free interest rate
Dividend yield
Remaining expected term of underlying securities (years)
$
$
March 31,
2016
March 31,
2015
$
$
2.17
1.00
73.35 %
0.59 %
—
0.96
3.54
1.00
76.80%
0.56%
—
1.96
In accordance with the terms of the warrant agreements, if, prior to the expiration date of the warrants, the Company issues additional
shares of common stock, as defined below, without consideration or for a consideration per share less than the exercise price of the
warrants in effect immediately prior to such issue, then the exercise price shall be reduced, concurrently with such issue, to a price
(calculated to the nearest cent) determined by multiplying such exercise price by a fraction, (A) the numerator of which shall be
(1) the number of shares of common stock outstanding immediately prior to such issue plus (2) the number of shares of common stock
which the aggregate consideration received or to be received by the Company for the total number of additional shares of common
stock so issued would purchase at such exercise price; and (B) the denominator of which shall be the number of shares of common
stock outstanding immediately prior to such issue plus the number of such additional shares of common stock so issued; provided that
(i) all shares of common stock issuable upon conversion or exchange of convertible securities outstanding immediately prior to such
issue shall be deemed to be outstanding, and (ii) the number of shares of common stock deemed issuable upon conversion or exchange
of such outstanding convertible securities shall be determined without giving effect to any adjustments to the conversion or exchange
price or conversion or exchange rate of such convertible securities resulting from the issuance of additional shares of common stock
that is the subject of this calculation. For purposes of the warrants, “additional shares of common stock” shall mean all shares of
common stock issued by the Company after the effective date (including without limitation any shares of common stock issuable upon
conversion or exchange of any convertible securities or upon exercise of any option or warrant, on an as-converted basis), other than:
(i) shares of common stock (and/or warrants for any class of equity securities of the Company) issued or issuable upon conversion or
exchange of any convertible securities or exercise of any options or warrants outstanding on the effective date; (ii) shares of common
stock issued or issuable by reason of a dividend, stock split, split-up or other distribution on shares of common stock; (iii) shares of
common stock (or options with respect thereto) issued or issuable to employees or directors of, or consultants to, the Company or any
of its subsidiaries pursuant to a plan, agreement or arrangement approved by the Board of Directors of the Company; (iv) any
securities issued or issuable by the Company pursuant to (A) the Private Placement; or (B) the Merger; (v) securities issued pursuant
to acquisitions or strategic transactions approved by a majority of disinterested directors of the Company, provided that any such
issuance shall only be to a person which is, itself or through its subsidiaries, an operating company in a business synergistic with the
business of the Company and in which the Company receives benefits in addition to the investment of funds, but shall not include a
transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary
business is investing in securities and (vi) securities issued to financial institutions, institutional investors or lessors in connection with
credit arrangements, equipment financings or similar transactions approved by a majority of disinterested directors of the Company,
but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity
whose primary business is investing in securities.
Upon each adjustment of the exercise price pursuant to the provisions stated above, the number of warrant shares issuable upon
exercise of the warrants shall be adjusted by multiplying a number equal to the exercise price in effect immediately prior to such
adjustment by the number of warrant shares issuable upon exercise of the warrant immediately prior to such adjustment and dividing
the product so obtained by the adjusted exercise price.
5. Stockholders’ Equity
Common stock
In May of 2008, the Board of Directors of the Company approved the 2008 Equity Incentive Plan (the “2008 Plan”). The 2008 Plan
authorized the issuance of up to 1,521,584 common shares for awards of incentive stock options, non-statutory stock options,
restricted stock awards, restricted stock award units, and stock appreciation rights. The 2008 Plan terminates on July 1, 2018. No
shares have been issued under the 2008 Plan since 2011, and the Company does not intend to issue any additional shares from the
2008 Plan in the future.
F-16
In January 2012, the Board of Directors of the Company approved the 2012 Equity Incentive Plan (the “2012 Plan”). The 2012 Plan
authorized the issuance of up to 6,553,986 shares of common stock for awards of incentive stock options, non-statutory stock options,
stock appreciation rights, restricted stock, restricted stock units, performance units, performance shares, and other stock or cash
awards. The Board of Directors and stockholders of the Company approved an amendment to the 2012 Plan in August 2013 to
increase the number of shares of common stock that may be issued under the 2012 Plan by 5,000,000 shares. In addition, the Board of
Directors and stockholders of the Company approved an amendment to the 2012 Plan in August 2015 to further increase the number
of shares of common stock that may be issued under the 2012 Plan by 6,000,000 shares, bringing the aggregate shares issuable under
the 2012 Plan to 17,553,986. The 2012 Plan as amended and restated became effective on August 20, 2015 and terminates ten years
after such date. As of March 31, 2016, 6,486,736 shares remain available for issuance under the 2012 plan.
The Company filed a shelf registration statement on Form S-3 (File No. 333-189995), or the 2013 Shelf, with the SEC on July 17,
2013 authorizing the offer and sale in one or more offerings of up to $100,000,000 in aggregate of common stock, preferred stock,
debt securities, or warrants to purchase common stock, preferred stock or debt securities, or any combination of the foregoing, either
individually or as units comprised of one or more of the other securities. This 2013 Shelf was declared effective by the SEC on
July 26, 2013.
On August 2, 2013, the Company entered into an Underwriting Agreement with Lazard Capital Markets LLC, acting as representative
of the underwriters named in the Underwriting Agreement and joint book-runner with Oppenheimer & Co. Inc., relating to the
issuance and sale of 10,350,000 shares of the Company’s common stock, which includes the issuance and sale of 1,350,000 shares
pursuant to an overallotment option exercised by the Underwriters on August 5, 2013 (the “2013 Offering”). JMP Securities LLC and
Maxim Group LLC each acted as co-managers for the 2013 Offering. The price to the public in the 2013 Offering was $4.50 per share,
and the Underwriters purchased the shares from the Company pursuant to the Underwriting Agreement at a price of $4.23 per share.
The net proceeds to the Company from the 2013 Offering were approximately $43.4 million, after deducting underwriting discounts
and commissions and other offering expenses of $3.2 million payable by the Company, including the Underwriters’ exercise of the
overallotment option. The transactions contemplated by the Underwriting Agreement closed on August 7, 2013.
In November 2013, the Company entered into an equity distribution agreement with an investment banking firm. Under the terms of
the distribution agreement, the Company may offer and sell up to 4,000,000 shares of its common stock, from time to time, through
the investment bank in at-the-market offerings, as defined by the SEC, and pursuant to the 2013 Shelf. During the years ended March
31, 2016, 2015 and 2014, the Company issued 0, 2,197,768 and 334,412 shares of common stock in at-the-market offerings under the
distribution agreement with net proceeds of $0, $16.1 million and $3.5 million, respectively.
In December 2014, the Company entered into an equity offering sales agreement with another investment banking firm. Under the
terms of the sales agreement, the Company may offer and sell shares of its common stock, from time to time, through the investment
bank in at-the-market offerings, as defined by the SEC, and pursuant to the Company’s 2013 Shelf. During the years ended March 31,
2016 and 2015, the Company issued 0 and 1,000,000 shares of common stock in at-the-market offerings under the sales agreement
with net proceeds of $0 and $6.2 million, respectively. The Company intends to use the net proceeds raised through any at-the-market
sales for general corporate purposes, including research and development, the commercialization of the Company’s products, general
administrative expenses, and working capital and capital expenditures.
The Company will limit future sales under the 2013 distribution agreement and the 2014 sales agreement to ensure that it does not
exceed the maximum amount available for sale under its effective shelf registration statement previously filed with the SEC. Based on
its use of the shelf registration statement through March 31, 2016, the Company cannot sell more than an aggregate of $26,777,785 in
shares of common stock under the 2013 distribution agreement and the 2014 sales agreement.
A shelf registration statement on Form S-3 (File No. 333-202382), or the 2015 shelf, was filed with the SEC on February 27, 2015
authorizing the offer and sale in one or more offerings of up to $190,000,000 in aggregate of common stock, preferred stock, debt
securities, warrants to purchase common stock, preferred stock or debt securities, or any combination of the foregoing, either
individually or as units comprised of one or more of the other securities. The 2015 shelf was declared effective by the SEC on March
17, 2015.
In addition, during the years ended March 31, 2016 and 2015, the Company issued 32,914 and 210,600 shares of common stock upon
exercise of 43,796 and 211,647 warrants, respectively.
During the years ended March 31, 2016 and 2015, the Company issued 116,001 and 205,033 shares of common stock upon exercise of
116,001 and 205,684 stock options, respectively.
On June 18, 2015, the Company entered into an Underwriting Agreement with Jefferies LLC and Piper Jaffray & Co., acting as
representatives of the underwriters named in the 2015 Underwriting Agreement and as joint book-running managers, relating to the
issuance and sale of 9,425,000 shares of the Company’s common stock, par value $0.001 per share (the “2015 Offering”). The price to
F-17
the public in the 2015 Offering was $4.25 per share, and the Underwriters have agreed to purchase the shares from the Company
pursuant to the 2015 Underwriting Agreement at a price of $3.995 per share. Under the terms of the 2015 Underwriting Agreement,
the Company granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 1,413,750 shares. The
Company issued 10,838,750 shares of common stock pursuant to the 2015 Underwriting Agreement, including shares issuable upon
the exercise of the over-allotment option, with net proceeds of approximately $43.1 million, after deducting underwriting discounts
and commissions and expenses payable by the Company. The shares were issued pursuant to the 2015 Shelf.
Restricted stock awards
On August 6, 2012, 200,000 restricted stock awards were issued to a member of senior management, the vesting of which was
performance based with achievement to be measured at December 31, 2014 or earlier if the metric was achieved. As of
December 31, 2014, the Company had determined that three of the four target metrics had been achieved with the fourth performance
metric criterion not met resulting in 150,000 shares of restricted stock vested and the remaining 50,000 restricted stock awards
surrendered back to the Company unvested. The Company recognized the related stock-based compensation expense over the
requisite service period ending on March 31, 2015.
During the year ended December 31, 2012, the Company issued an aggregate 950,000 of restricted stock awards to certain members of
senior management and 130,000 restricted stock awards to non-executive employees. The vesting schedule is 25% on each
anniversary of the vesting start date over four years. Additionally, the Company issued 100,000 restricted stock awards to a consultant.
The vesting schedule is 100% after six months.
During the year ended March 31, 2014, 218,655 restricted stock awards were surrendered related to shares of common stock returned
to the Company, at the option of the holder, to cover the tax liability related to the vesting of 405,000 restricted stock awards. Upon
the return of the common stock, 218,655 stock option grants with immediate vesting were granted to the individual at the vesting date
market value strike price.
During the year ended March 31, 2014, the Company issued an aggregate of 60,000 restricted stock units with immediate vesting to a
consultant.
During the year ended March 31, 2015, 137,816 restricted stock awards were surrendered related to shares of common stock returned
to the Company, at the option of the holder, to cover the tax liability related to the vesting of 255,000 restricted stock awards. Upon
the return of the common stock, 137,816 stock option grants with immediate vesting were granted to the individual at the vesting date
market value strike price.
During the year ended March 31, 2016, 129,900 restricted stock awards were surrendered related to shares of common stock returned
to the Company, at the option of the holder, to cover the tax liability related to the vesting of 250,000 restricted stock awards. Upon
the return of the common stock, 129,900 stock option grants with immediate vesting were granted to the individual at the vesting date
market value strike price.
During the year ended March 31, 2016, there were 2,500 restricted stock awards forfeited by one employee upon termination of their
employment with the Company.
A summary of the Company’s restricted stock award activity is as follows:
Unvested at March 31, 2013
Granted
Vested
Canceled / forfeited
Unvested at March 31, 2014
Granted
Vested
Canceled / forfeited
Unvested at March 31, 2015
Granted
Vested
Canceled / forfeited
Unvested at March 31, 2016
F-18
Number of
Shares
985,742
60,000
(472,247)
—
573,495
—
(262,245)
(52,500)
258,750
—
(250,000)
(2,500)
6,250
The fair value of each restricted stock award is recognized as stock-based compensation expense over the vesting term of the award.
The Company recorded restricted stock-based compensation expense in operating expenses for employees and non-employees of
approximately $215,000, $421,000, and $817,000, during the years ended March 31, 2016, 2015 and 2014, respectively. Expense for
each of the periods included approximately $5,000, $15,000, and $16,000, for research and development during the years ended
March 31, 2016, 2015 and 2014, respectively. General and administrative expense for the years ended March 31, 2016, 2015 and 2014
were approximately $210,000, $406,000, and $801,000, respectively.
As of March 31, 2016, total unrecognized restricted stock-based compensation expense was approximately $3,000, which will be
recognized over a weighted average period of 0.25 years.
Stock options
During the years ended March 31, 2016 and 2015, under the 2012 Equity Incentive Plan, 2,966,778 and 1,429,191 incentive stock
options were issued, respectively, at various exercise prices. The stock options generally vest on the one year anniversary of the grant
date, quarterly over a three year period, or over a four-year period, with a quarter vesting on either the one year anniversary of
employment or the one year anniversary of the vesting commencement date, and the remainder vesting ratably over the remaining
36 month terms with the exception of 129,900 and 139,316 of the incentive stock option grants during the years ended March 31, 2016
and 2015, respectively, that have immediate vesting at the grant date, 0 and 56,500 of the incentive stock option grants in the years
ended March 31, 2016 and 2015, respectively, that vest quarterly over three years, and 185,000 and 128,500 of the incentive stock
option grants in the years ended March 31, 2016 and 2015, respectively, that vest after one full year.
The following table summarizes stock option activity for the years ended March 31, 2016 and 2015:
Outstanding at March 31, 2014
Options granted
Options canceled
Options exercised
Outstanding at March 31, 2015
Options granted
Options canceled
Options exercised
Outstanding at March 31, 2016
Vested and Exercisable at March 31, 2016
Options
Outstanding
Weighted-
Average
Exercise Price
5,935,888
1,429,191
(45,847)
(205,684)
7,113,548
2,966,778
(349,698)
(116,001)
9,614,627
5,165,836
$
$
$
$
$
$
$
$
$
$
4.87
6.18
7.17
1.73
5.21
3.87
6.30
2.76
4.79
4.45
$
$
$
$
$
$
Aggregate
Intrinsic
Value
20,482,823
883,795
4,969,499
112,441
1,927,137
1,860,789
The weighted-average remaining contractual term of options exercisable and outstanding at March 31, 2016 was approximately 6.16
years.
The Company uses the Black-Scholes valuation model to calculate the fair value of stock options. Stock-based compensation expense
is recognized over the vesting period using the straight-line method. The fair value of stock options was estimated at the grant date
using the following weighted average assumptions:
Dividend yield
Volatility
Risk-free interest rate
Expected life of options
Weighted average grant date fair value
Year Ended
March 31, 2016
Year Ended
March 31, 2015
—
73.96 %
1.57 %
6.00 years
2.52
$
$
—
76.90%
1.60%
6.00 years
4.14
The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. Due to the
Company’s limited historical data, the estimated volatility incorporates the historical and implied volatility of comparable companies
whose share prices are publicly available. The risk-free interest rate assumption was based on the U.S. Treasury rates. The weighted
average expected life of options was estimated using the average of the contractual term and the weighted average vesting term of the
options. Certain options granted to consultants are subject to variable accounting treatment and are required to be revalued until
vested.
F-19
The total stock option based compensation recorded as operating expense was approximately $8,341,000, $6,599,000, and $3,783,000
for the years ended March 31, 2016, 2015 and 2014, respectively. Research and development expense for the years ended March 31,
2016, 2015 and 2014 were approximately $1,243,000, $1,175,000, and $462,000, respectively. General and administrative expense for
the years ended March 31, 2016, 2015 and 2014 were approximately $7,098,000, $5,424,000, $3,321,000, respectively.
Included in total stock option-based compensation for the year ended March 31, 2016 is additional expense resulting from acceleration
of the vesting schedule to fully vest options held by a terminated executive as pursuant to the 2012 Equity Incentive Plan.
Additionally, as part of the severance agreement, a modification was made to extend the exercise period of the fully vested options,
resulting in an incremental expense.
The total unrecognized compensation cost related to unvested stock option grants as of March 31, 2016 was approximately
$13,385,000 and the weighted average period over which these grants are expected to vest is 2.48 years.
Warrants
During the years ended December 31, 2012 and 2011, the Company issued warrants to investors to purchase 21,347,182 and
2,909,750 shares, respectively, of its common stock.
During the years ended March 31, 2016, 2015 and 2014, 0, 203,000 and 225,000 of these warrants were exercised for cash proceeds of
approximately $0, $445,000 and $210,000, respectively, and 43,796, 8,647 and 2,628,003 of these warrants were exercised through a
cashless exercise for issuance of 32,914, 7,600 and 2,139,577 shares of common stock, respectively.
During the year ended March 31, 2014, derivative liability warrants of 1,920,874 were exercised.
During the year ended March 31, 2014, the Company entered into amendment agreements for 269,657 warrants to purchase common
stock which reduced the exercise price of the warrants from $1.00 to $0.85, which removed the down-round price protection provision
of the warrant agreement related to the adjustment of exercise price upon issuance of additional shares of common stock. As a result
of the removal of the down-round price protection provision, the warrants were reclassified from liability to equity instruments at their
fair value. The Company determined the incremental expense associated with the modification based on the fair value of the awards
prior to and subsequent to the modification. The fair value of the awards subsequent to modification was calculated using the Black-
Scholes model. The incremental expense associated with the modification of approximately $12,000 was recognized as interest
expense for the year ended March 31, 2014.
In 2012 the Company issued a total of 650,000 warrants to purchase common stock, in connection with consulting agreements, at
prices ranging from $1.70 to $3.24, with lives ranging from two to five years, to be earned over service periods of up to six months.
During the years ended March 31, 2016 and 2015, no warrants held by consultants were exercised. During the year ended March 31,
2014, 348,630 warrants held by consultants were exercised resulting in proceeds to the Company of approximately $891,000. As of
March 31, 2016, 1,370 of these warrants are outstanding.
During November 2013, the Company entered into an agreement with a consultant for services. In connection with the agreement, the
Company issued 75,000 warrants to purchase common stock, at a price of $7.36, with a life of five years, to be earned over a twelve
month service period. The fair value of the warrants was estimated to be approximately $404,000, which was recognized as a prepaid
asset and is being amortized over the term of the consulting agreement. These warrants were classified as equity instruments because
they do not contain any anti-dilution provisions. The Black-Scholes model, using a volatility rate of 96.90% and a risk-free interest
rate factor of 0.60%, was used to determine the value. The Company recognized approximately $0 and $43,000 during the years ended
March 31, 2016 and 2015, respectively, related to these services. As of December 31, 2014, these warrants were fully expensed.
Additionally, during September 2014, the Company issued 50,000 warrants to a consultant in recognition of services previously
provided. These warrants were classified as equity instruments because they do not contain any anti-dilution provisions. As of
December 31, 2014, the full amount of the warrants related to these services, approximately $237,000 had been recognized.
During November 2014 the Company entered into an agreement with a consultant for services. In connection with the agreement, the
Company issued 145,000 warrants to purchase common stock, at a price of $6.84, with a life of five years, to be earned over a
seventeen month service period ending on March 31, 2016. The final number of vested warrant shares was 95,000, based on
management’s judgment of the satisfaction of specific performance metrics. The fair value of the warrants was estimated to be
approximately $74,000, which was revalued and amortized over the term of the consulting agreement. These warrants were classified
as equity instruments because they do not contain any anti-dilution provisions. The Black-Scholes model, using a volatility rate of
73.4% and a risk-free interest rate factor of 1.21%, was used to determine the value as of March 31, 2016. The Company recognized
approximately $41,000 and $36,000 during the years ended March 31, 2016 and 2015, respectively, related to these services. As of
March 31, 2016, these warrants were fully expensed.
F-20
The following table summarizes warrant activity for the years ended March 31, 2016 and 2015:
Balance at March 31, 2014
Granted
Expired / Canceled
Exercised
Balance at March 31, 2015
Granted
Expired / Canceled
Exercised
Balance at March 31, 2016
Warrants
Weighted-Average
Exercise Price
1,194,756 $
195,000 $
—
(211,647 ) $
1,178,109 $
—
(87,500 ) $
(43,796 ) $
1,046,813 $
1.79
7.04
—
2.14
2.59
—
7.06
1.00
2.29
The warrants outstanding at March 31, 2016 are immediately exercisable at prices between $0.85 and $7.62 per share, and have a
weighted average remaining term of approximately 1.28 years.
Common stock reserved for future issuance
Common stock reserved for future issuance consisted of the following at March 31, 2016:
Common stock warrants outstanding
Common stock options outstanding under the 2008 Plan
Common stock options outstanding and reserved under the 2012 Plan
Total
Preferred stock
1,046,813
622,192
15,479,171
17,148,176
The Company is authorized to issue 25,000,000 shares of preferred stock. There are no shares of preferred stock currently outstanding,
and the Company has no present plans to issue shares of preferred stock.
6. Commitments and Contingencies
Operating leases
The Company leases laboratory and office space in San Diego, California under three non-cancelable leases as described below.
Since July 2012, the Company has leased its main facility at 6275 Nancy Ridge Drive, San Diego, CA 92121. The lease, as amended
in 2013 and 2015, consists of approximately 30,895 rentable square feet containing laboratory, clean room and office space. Monthly
rental payments are currently approximately $83,000 per month with 3% annual escalators. The lease term expires September 1, 2021
with the option to terminate on or after September 1, 2019. The Company also has a right of first refusal on adjacent additional
premises of approximately 14,500 square feet.
On January 9, 2015, the Company entered into an agreement to lease a second facility consisting of 5,803 rentable square feet of
office and lab space located at 6310 Nancy Ridge Drive, San Diego, CA 92121. The term of the lease is 36 months, beginning on
February 1, 2015 and ending on January 31, 2018, with monthly rental payments of approximately $12,000 commencing on April 1,
2015. In addition, there are annual rent escalations of 3% on each 12-month anniversary of the lease commencement date.
On December 28, 2015, the Company entered into an agreement to lease a third facility consisting of 12,088 rentable square feet of
office space located at 6166 Nancy Ridge Drive, San Diego, CA 92121. The term of the lease is 12 months, beginning on February 1,
2016 and ending on January 31, 2017, with monthly rental payments of $15,000 commencing on February 1, 2016.
The Company records rent expense on a straight-line basis over the life of the leases and records the excess of expense over the
amounts paid as deferred rent. In addition, one of the leases provides for certain improvements made for the Company’s benefit to be
funded by the landlord. Such costs, totaling approximately $518,000 to date, have been capitalized as fixed assets and included in
deferred rent.
Rent expense was approximately $1,088,000, $968,000, and $561,500 for the years ended March 31, 2016, 2015 and 2014,
respectively.
F-21
Future minimum rental payments required under operating leases that have initial or remaining non-cancelable lease terms in excess of
one year as of March 31, 2016, are as follows (in thousands):
Fiscal year ended March 31, 2017
Fiscal year ended March 31, 2018
Fiscal year ended March 31, 2019
Fiscal year ended March 31, 2020
Fiscal year ended March 31, 2021
Thereafter
Total
Legal matters
$
$
1,313
1,148
1,044
1,072
1,104
467
6,148
In addition to commitments and obligations in the ordinary course of business, the Company may be subject, from time to time, to
various claims and pending and potential legal actions arising out of the normal conduct of its business. The Company assesses
contingencies to determine the degree of probability and range of possible loss for potential accrual in its financial statements.
Because litigation is inherently unpredictable and unfavorable resolutions could occur, assessing litigation contingencies is highly
subjective and requires judgments about future events. When evaluating contingencies, the Company may be unable to provide a
meaningful estimate due to a number of factors, including the procedural status of the matter in question, the presence of complex or
novel legal theories, and/or the ongoing discovery and development of information important to the matters. In addition, damage
amounts claimed in litigation against it may be unsupported, exaggerated or unrelated to possible outcomes, and as such are not
meaningful indicators of its potential liability.
The Company regularly reviews contingencies to determine the adequacy of its accruals and related disclosures. During the period
presented, the Company has not recorded any accrual for loss contingencies associated with such claims or legal proceedings;
determined that an unfavorable outcome is probable or reasonably possible; or determined that the amount or range of any possible
loss is reasonably estimable. However, the outcome of legal proceedings and claims brought against the Company is subject to
significant uncertainty. Therefore, although management considers the likelihood of such an outcome to be remote, if one or more of
these legal matters were resolved against the Company in a reporting period, the Company’s consolidated financial statements for that
reporting period could be materially adversely affected.
7. Licensing Agreements and Research Contracts
University of Missouri
In March 2009, the Company entered into a license agreement with the Curators of the University of Missouri to in-license certain
technology and intellectual property relating to self-assembling cell aggregates and to intermediate cellular units. The Company
received the exclusive worldwide rights to commercialize products comprising this technology for all fields of use. The Company is
required to pay the University of Missouri royalties ranging from 1% to 3% of net sales of covered tissue products, and of the fair
market value of covered tissues transferred internally for use in the Company’s commercial service business, depending on the level of
net sales achieved by the Company each year. A minimum annual royalty of $25,000 is due beginning in calendar 2017 and will be
credited against royalties due during the subsequent twelve months. The license agreement terminates upon expiration of the patents
licensed and is subject to certain conditions as defined in the license agreement, which are expected to expire after 2029.
In March 2010, the Company entered into a license agreement with the Curators of the University of Missouri to in-license certain
technology and intellectual property relating to engineered biological nerve grafts. The Company received the exclusive worldwide
rights to commercialize products comprising this technology for all fields of use. The Company is required to pay the University of
Missouri royalties ranging from 1% to 3% of net sales of covered tissue products depending on the level of net sales achieved by the
Company each year. The license agreement terminates upon expiration of the patents licensed and is subject to certain conditions as
defined in the license agreement.
Clemson University
In May 2011, the Company entered into a license agreement with Clemson University Research Foundation to in-license certain
technology and intellectual property relating to ink-jet printing of viable cells. The Company received the exclusive worldwide rights
to commercialize products comprising this technology for all fields of use. The Company is required to pay the University royalties
ranging from 1.5% to 3% of net sales of covered tissue products and the fair market value of covered tissues transferred internally for
use in the Company’s commercial service business, depending on the level of net sales reached each year. The license agreement
terminates upon expiration of the patents licensed, which is expected to expire in May 2024, and is subject to certain conditions as
defined in the license agreement. Minimum annual royalty payments of $20,000 were due for each of the two years beginning with
F-22
calendar 2014, and $40,000 per year beginning with calendar 2016. The annual minimum royalty is creditable against royalties owed
during the same calendar year.
Capitalized license fees consisted of the following (in thousands):
License fees
Less accumulated amortization
License fees, net
March 31,
2016
March 31,
2015
$
$
148 $
(43 )
105 $
114
(34)
80
The above license fees, net of accumulated amortization, are included in Other Assets in the accompanying balance sheets and are
being amortized over the life of the related patents. Amortization expense of licenses was approximately $9,700, $8,500, and $8,500
for the years ended March 31, 2016, 2015 and 2014, respectively. At March 31, 2016, the weighted average remaining amortization
period for all licenses was approximately 11 years. The annual amortization expense of licenses for the next five years is estimated to
be approximately $10,300 per year.
8. Income Taxes
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for
financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred tax
assets are as follows as of March 31, 2016 and 2015 (in thousands):
Deferred tax assets:
Net operating loss carry forwards
Research and development credits
Depreciation and amortization
Accrued expenses and reserves
Stock compensation
Other, net
Total deferred tax assets
Valuation allowance
March 31,
2016
March 31,
2015
$
$
— $
—
(105 )
862
5,584
12
6,353
(6,353 )
— $
—
—
(48)
826
3,462
6
4,246
(4,246)
—
A full valuation allowance has been established to offset the deferred tax assets as management cannot conclude that realization of
such assets is more likely than not. Under the Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of our net operating
loss and research tax credit carryforwards to offset taxable income may be limited based on cumulative changes in ownership. We
have not completed an analysis to determine whether any such limitations have been triggered as of March 31, 2016. Until this
analysis is completed, we have removed the deferred tax assets related to net operating losses and research credits from our deferred
tax asset schedule. Further, until a study is completed and any limitation known, no amounts are being considered as an uncertain tax
position or disclosed as an unrecognized tax benefit. Due to the existence of the valuation allowance, future changes in the Company’s
unrecognized tax benefits will not impact its effective tax rate. Any carryforwards that will expire prior to utilization as a result of
such limitations will be removed from deferred tax assets with a corresponding reduction of the valuation allowance. The valuation
allowance increased by approximately $2,107,000 and $2,002,000 for the years ended March 31, 2016 and 2015, respectively.
The Company had federal and state net operating loss carryforwards of approximately $89,814,000 and $89,063,000 at March 31,
2016, respectively. The federal and state net operating loss carryforwards will begin expiring in 2028, unless previously utilized. The
net operating loss carryforwards included approximately $6,332,000 of windfall tax benefits related to stock compensation that will be
recorded as an increase to additional paid in capital if and when realized.
The Company had federal and state research tax credit carryforwards of approximately $1,351,000 and $1,578,000 at March 31, 2016,
respectively. The federal research tax credit carryforwards begin expiring in 2028. The state research tax credit carryforwards do not
expire.
In 2009 the Company adopted the accounting guidance for uncertainty in income taxes pursuant to ASC 740-10. The adoption of this
guidance did not have a material impact on the Company’s consolidated financial statements. The Company did not record any
accruals for income tax accounting uncertainties for the year ended March 31, 2016.
F-23
The Company’s policy is to recognize interest and penalties that would be assessed in relation to the settlement value of unrecognized
tax benefits as a component of income tax expense. The Company did not accrue either interest or penalties from inception through
March 31, 2016.
The Company does not have any unrecognized tax benefits that will significantly decrease or increase within 12 months of March 31,
2016.
The Company is subject to tax in the United States and in various state jurisdictions. As of March 31, 2016, the Company’s tax years
from inception are subject to examination by the tax authorities. The Company is not currently under examination by any U.S. federal
or state jurisdictions.
9. Concentrations
Credit risk and significant customers
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash
investments. The Company maintains cash balances at various financial institutions primarily located within the United States.
Accounts at these institutions are secured by the Federal Deposit Insurance Corporation. Balances may exceed federally insured limits.
The Company has not experienced losses in such accounts, and management believes that the Company is not exposed to any
significant credit risk with respect to its cash and cash equivalents.
The Company is also potentially subject to concentrations of credit risk in its revenues and accounts receivable. Because it is in the
early commercial stage, the Company’s revenues to date have been derived from a relatively small number of customers and
collaborators. However, the Company has not historically experienced any accounts receivable write-downs and management does not
believe significant credit risk exists as of March 31, 2016.
10. Defined Contribution Plan
The Company has a defined contribution 401(k) plan covering substantially all employees. During the year ended March 31, 2015, the
401(k) plan was amended (“the Amended Plan”) to include an employer matching provision. Under the terms of the Amended Plan,
the Company will make matching contributions on up to the first 6 % of compensation contributed by its employees. Amounts
expensed under the Company’s 401(k) plan for the years ended March 31, 2016 and 2015 were approximately $277,000 and $57,000,
respectively.
11. Recent Accounting Pronouncements
In May 2014, the FASB issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers, which
requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services
to customers. The standard will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. The
new standard was originally effective for public companies for annual reporting periods beginning after December 15, 2016, with no
early application permitted. In August 2015, the FASB issued ASU No. 2015-14 that defers by one year the effective date for all
entities, with application permitted as of the original effective date. The updated standard becomes effective for us on April 1, 2018,
with early adoption permitted as of April 1, 2017. The standard permits the use of either the retrospective or cumulative effect
transition method. We are evaluating the effect that these updates will have on our consolidated financial statements and related
disclosures. We have not yet selected a transition method nor have we determined the effect of these standards on our ongoing
financial reporting.
In February 2016, the FASB issued ASU 2016-02, Leases, which requires an entity to recognize lease assets and lease liabilities on the
balance sheet for leases with terms of more than 12 months and to disclose key information about leasing arrangements. This new
guidance is effective for us on April 1, 2019, with early adoption permitted in any interim or annual period. The Company is currently
evaluating the impact that this guidance will have on its financial statements and related disclosures.
In November 2015, the FASB issued an ASU 2015-17, which requires noncurrent classification of all deferred tax assets and liabilities
for annual periods beginning after December 31, 2016, with early adoption permitted. The Company has elected to early adopt this
update for the year ended March 31, 2017. The Company will apply this standard on a prospective basis. The effect of this update is
not expected to be material to our financial statements.
F-24
12. Quarterly Financial Data (unaudited)
The following quarterly financial data, in the opinion of management, fairly presents the results for the periods presented (in
thousands, except per share data):
Revenue
Net loss
Net loss per common share - basic and diluted
Weighted average shares used in computing net
loss per common share—basic and diluted
Revenue
Net loss
Net loss per common share - basic and diluted
Weighted average shares used in computing net
loss per common share—basic and diluted
13. Subsequent Events
None.
First Quarter Second Quarter Third Quarter
Year Ended March 31, 2016
$
306 $
(8,491)
(0.10)
301 $
(11,257 )
(0.12 )
328 $
(10,455)
(0.11)
Fourth Quarter
548
(8,372)
(0.09)
82,993,966
92,385,150 92,396,358
92,402,668
First Quarter Second Quarter Third Quarter
Year Ended March 31, 2015
$
99 $
(6,433)
(0.08)
50 $
(8,858 )
(0.11 )
155 $
(6,993)
(0.09)
Fourth Quarter
267
(7,798)
(0.10)
78,241,373
78,933,884 80,491,120
80,946,849
F-25
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports
filed pursuant to the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is recorded, processed, summarized, and
reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated
to our management, including our principal executive officer and principal financial and accounting officer, as appropriate, to allow
timely decisions regarding required disclosure.
Under the supervision of our Chief Executive Officer and our Principal Financial Officer, and with the participation of all members of
management, we conducted an evaluation of our disclosure controls and procedures, as such term is defined under Rule 13a-
15(e) promulgated under the Exchange Act. Based on this evaluation, our principal executive officer and our principal financial officer
concluded that our disclosure controls and procedures were designed and operating effectively as of the end of the period covered by
this Annual Report on Form 10-K.
Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f). Our management’s annual report on internal control over financial reporting is set forth
below and the report of our independent registered public accounting firm is included on page F-3 of this Annual Report on Form 10-
K.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our system of
internal control over financial reporting is designed to provide reasonable assurance to our management and Board of Directors
regarding the preparation and fair presentation of our consolidated financial statements for external purposes in accordance with
generally accepted accounting principles.
Our management, under the supervision of our Chief Executive Officer and the Principal Financial Officer, assessed the effectiveness
of our internal control over financial reporting as of March 31, 2016. In making this assessment, we used the framework included in
Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on our evaluation under the criteria set forth in Internal Control — Integrated Framework (2013), our
management concluded that our internal control over financial reporting was effective as of March 31, 2016.
Auditor’s Attestation Report on Internal Control Over Financial Reporting
Mayer Hoffman McCann P.C., our independent registered public accounting firm, has audited our consolidated financial statements
included in this Annual Report on Form 10-K and has issued an attestation report, included herein, on the effectiveness of our internal
control over financial reporting as of March 31, 2016.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred
during the fourth quarter of the fiscal year ended March 31, 2016 to which this report relates that has materially affected, or is
reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer and our Principal Financial Officer, do not expect that our disclosure controls
or our internal control over financial reporting will prevent or detect all error and all fraud. A control system, no matter how well
designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The
design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered
relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute
assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been
detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can
35
occur because of simple error or mistake. Controls can also 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 is based in part on 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. Projections of any evaluation of controls effectiveness to future periods are subject to risks.
Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with
policies or procedures.
Item 9B. Other Information.
None.
36
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
Information relating to our directors, executive officers and corporate governance, including our Code of Business Conduct, will be
included in the proxy statement for the 2016 annual meeting of the Company’s stockholders, expected to be filed within 120 days of
the end of our fiscal year, which is incorporated herein by reference. The full text of our Code of Business Conduct, which is the code
of ethics that applies to all of our officers, directors and employees, can be found in the “Investors” section of our website accessible
to the public at www.organovo.com.
Item 11. Executive Compensation.
Information relating to executive compensation will be included in the proxy statement for the 2016 annual meeting of the Company’s
stockholders, expected to be filed within 120 days of the end of our fiscal year, which is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Information relating to the beneficial ownership of our common stock will be included in the proxy statement for the 2016 annual
meeting of the Company’s stockholders, expected to be filed within 120 days of the end of our fiscal year, which is incorporated
herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
Information relating to certain relationships and related transactions and director independence will be included in the proxy statement
for the 2016 annual meeting of the Company’s stockholders, expected to be filed within 120 days of the end of our fiscal year, which
is incorporated herein by reference.
Item 14. Principal Accountant Fees and Services.
Information relating to principal accountant fees and services will be included in the proxy statement for the 2016 annual meeting of
the Company’s stockholders, expected to be filed within 120 days of the end of our fiscal year, which is incorporated herein by
reference.
37
Item 15. Exhibits, Financial Statement Schedules.
(a).The following documents have been filed as part of this Annual Report on Form 10-K:
PART IV
1.
2.
3.
Consolidated Financial Statements: The information required by this item is included in Item 8 of Part II of this report.
Financial Statement Schedules: Financial statement schedules required under the related instructions are not applicable for
the years ended March 31, 2016 and 2015 and have therefore been omitted.
Exhibits: The exhibits listed in the Exhibit Index attached to this report are filed or incorporated by reference as part of
this Annual Report.
(b).The exhibits listed in the accompanying Exhibit Index are filed or incorporated by reference as part of this Annual Report on
Form 10-K.
38
Pursuant to the requirements of the Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this
Report to be signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
ORGANOVO HOLDINGS, INC.
By:
/s/ Keith Murphy
Keith Murphy,
Chairman of the Board, Chief Executive
Officer and President
Date: June 9, 2016
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Keith
Murphy and Jennifer Bush, and each of them individually, as the undersigned’s true and lawful attorneys-in-fact and agents, with full
power of substitution and resubstitution, for the undersigned and in the undersigned’s name, place, and stead, in any and all capacities,
to sign any and all amendments to this Report, 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 the undersigned might or could do in person, hereby ratifying and confirming that all said attorneys-in-fact and
agents, or any of them or their respective substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the
capacities and on the dates indicated.
Signature
Title
Chairman of the Board, Chief Executive Officer
and President (Principal Executive Officer,
Principal Financial Officer and Principal
Accounting Officer)
Director
Director
Director
Director
Director
/s/ Keith Murphy
Keith Murphy
/s/ Robert Baltera, Jr.
Robert Baltera, Jr.
/s/ James Glover
James Glover
/s/ Tamar Howson
Tamar Howson
/s/ Richard Heyman
Richard Heyman
/s/ Kirk Malloy
Kirk Malloy
Date
June 9, 2016
June 9, 2016
June 9, 2016
June 9, 2016
June 9, 2016
June 9, 2016
Exhibit No.
2.1
2.2
2.3
2.4
2.5
2.6
2.7
3.1
3.2
4.1
4.3
4.4
10.1
10.2
10.3
10.4+
10.5+
10.6+
10.7+
EXHIBIT INDEX
Description
Agreement and Plan of Merger and Reorganization, dated as of February 8, 2012, by and among Organovo Holdings, Inc.
a Delaware corporation, Organovo Acquisition Corp., a Delaware corporation and Organovo, Inc., a Delaware corporation
(incorporated by reference from Exhibit 2.1 to the Company’s Current Report on Form 8-K, as filed with the SEC on
February 13, 2012)
Certificate of Merger as filed with the Delaware Secretary of State effective February 8, 2012 (incorporated by reference
from Exhibit 2.2 to the Company’s Current Report on Form 8-K, as filed with the SEC on February 13, 2012)
Articles of Merger as filed with the Nevada Secretary of State effective December 28, 2011 (incorporated by reference
from Exhibit 2.1 to the Company’s Current Report on Form 8-K, as filed with the SEC on February 3, 2012 (the
“February 2012 Form 8-K”)
Agreement and Plan of Merger, dated as of December 28, 2011, by and between Real Estate Restoration and Rental, Inc.
and Organovo Holdings, Inc. (incorporated by reference from Exhibit 2.2 to the Company’s Current Report on Form 8-K,
as filed with the SEC on January 4, 2012)
Certificate of Merger as filed with the Delaware Secretary of State effective January 30, 2012 (incorporated by reference
from Exhibit 2.3 to the February 2012 Form 8-K)
Agreement and Plan of Merger, dated as of January 30, 2012, by and between Organovo Holdings, Inc. (Nevada) and
Organovo Holdings, Inc. (Delaware) (incorporated by reference from Exhibit 2.2 to the February 2012 Form 8-K)
Articles of Merger as filed with the Nevada Secretary of State effective January 30, 2012 (incorporated by reference from
Exhibit 2.4 to the February 2012 Form 8-K)
Certificate of Incorporation of Organovo Holdings, Inc. (Delaware) (incorporated by reference from Exhibit 3.1 to the
February 2012 Form 8-K)
Bylaws of Organovo Holdings, Inc. (Delaware) (incorporated by reference from Exhibit 3.2 to the February 2012 Form 8-K)
Form of Bridge Warrant of Organovo, Inc. (incorporated by reference from Exhibit 4.1 to the Company’s Current Report
on Form 8-K, as filed with the SEC on February 13, 2012)
Form of Warrant of Organovo Holdings, Inc. ($1.00 exercise price) issued to Placement Agent (incorporated by reference
from Exhibit 4.2(i) to the Company’s Current Report on Form 8-K, as filed with the SEC on March 19, 2012)
Form of Warrant of Organovo Holdings, Inc. ($1.00 exercise price) issued to Placement Agent in exchange for Organovo,
Inc. warrant issued to Selling Agent (incorporated by reference from Exhibit 4.2(iii) to the Company’s Current Report on
Form 8-K, as filed with the SEC on March 19, 2012)
Split-Off Agreement, by and among Organovo Holdings, Inc., Organovo Split Corp., Deborah Lovig and James Coker
(incorporated by reference from Exhibit 10.9 to the Company’s Current Report on Form 8-K, as filed with the SEC on
February 13, 2012)
General Release Agreement by and among Organovo Holdings, Inc., Organovo Split Corp., Deborah Lovig and James
Coker (incorporated by reference from Exhibit 10.10 to the Company’s Current Report on Form 8-K, as filed with the
SEC on February 13, 2012)
Form of Share Cancellation Agreement and Release (incorporated by reference from Exhibit 10.11 to the Company’s
Current Report on Form 8-K, as filed with the SEC on February 13, 2012)
Organovo, Inc. 2008 Equity Incentive Plan (incorporated by reference from Exhibit 10.14 to the Company’s Current
Report on Form 8-K, as filed with the SEC on February 13, 2012)
Organovo Holdings, Inc. 2012 Equity Incentive Plan (incorporated by reference from Exhibit 10.15 to the Company’s
Current Report on Form 8-K, as filed with the SEC on February 13, 2012)
Form of Stock Option Award Agreement under the 2012 Equity Incentive Plan (incorporated by reference from
Exhibit 10.16 to the Company’s Current Report on Form 8-K, as filed with the SEC on February 13, 2012)
Form of Indemnification Agreement (incorporated by reference from Exhibit 10.17 to the Company’s Current Report on
Form 8-K, as filed with the SEC on February 13, 2012)
Exhibit No.
10.12†
10.13†
10.14†
10.15+
10.16
10.17+
10.18+
10.19
Description
License Agreement dated as of March 24, 2009, by and between Organovo, Inc. and the Curators of the University of
Missouri, **** (incorporated by reference from Exhibit 10.23 to the Company’s Current Report on Form 8-K, as filed
with the SEC on May 11, 2012)
License Agreement dated as of March 12, 2010 by and between the Company and the University of Missouri, ****
(incorporated by reference from Exhibit 10.24 to the Company’s Current Report on Form 8-K, as filed with the SEC on
May 11, 2012)
License Agreement dated as of May 2, 2011, by and between the Company and Clemson University Research
Foundation, **** (incorporated by reference from Exhibit 10.25 to the Company’s Current Report on Form 8-K, as filed
with the SEC on May 11, 2012)
Executive Employment Agreement, dated February 28, 2012, by and between Keith Murphy and Organovo, Inc.
(incorporated by reference from Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the SEC on
March 1, 2012)
First Amendment to Lease, dated December 4, 2013, by and between Organovo, Inc. and ARE-SD Region No. 25, LLC.
(incorporated by reference from Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q, as filed with the SEC on
February 6, 2014)
Forms of Executive Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement under the 2012 Equity
Incentive Plan. (incorporated by reference from Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q, as filed
with the SEC on February 6, 2014)
Forms of Performance Based Restricted Stock Grant Notice and Performance Based Restricted Stock Unit Agreement
under the 2012 Equity Incentive Plan. (incorporated by reference from Exhibit 10.6 to the Company’s Quarterly Report on
Form 10-Q, as filed with the SEC on February 6, 2014)
Controlled Equity OfferingSM Sales Agreement, dated December 30, 2014, by and between Organovo Holdings, Inc. and
Cantor Fitzgerald & Co. (incorporated by reference from Exhibit 10.1 to the Company’s Current Report on Form 8-K, as
filed with the SEC on December 30, 2014 )
10.20+
Form of Non-Employee Director Stock Option Award Agreement under the 2012 Equity Incentive Plan* (incorporated by
reference to Exhibit 10.35 to the Company’s Annual Report on Form 10-K, as filed with the SEC on June 6, 2015)
10.21+
Form of Executive Stock Option Award Agreement under the 2012 Equity Incentive Plan* (incorporated by reference to
Exhibit 10.36 to the Company’s Annual Report on Form 10-K, as filed with the SEC on June 6, 2015)
10.22†
Research Collaboration Agreement, dated March 31, 2016, by and between Organovo Holdings, Inc. and L’Oréal USA
Products, Inc.* (incorporated by reference to Exhibit 10.37 to the Company’s Annual Report on Form 10-K, as filed with
the SEC on June 6, 2015)
10.23+
10.24+
10.25+
Organovo Holdings, Inc. Severance and Change in Control Plan (incorporated by reference to Exhibit 10.2 to the
Company’s Quarterly Report on Form 10-Q, as filed with the SEC on November 9, 2015)
Form of Organovo Holdings, Inc. Severance and Change in Control Plan Participation Agreement (incorporated by
reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q, as filed with the SEC on November 9, 2015)
Consulting, Separation Agreement and Release, between Barry Michaels and Organovo Holdings, Inc., dated March 30,
2016 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the SEC on
April 5, 2016)
10.26+
Consulting Agreement, between Organovo Holdings, Inc., Organovo, Inc. and Barry Michaels, dated March 30, 2016
(incorporated by reference to the Company’s Current Report on Form 8-K, as filed with the SEC on April 5, 2016)
21.1
23.1
24.1
31.1
32.1
Subsidiaries of Organovo Holdings, Inc. (incorporated by reference from Exhibit 21.1 to the Company’s Current Report
on Form 8-K, as filed with the SEC on February 13, 2012)
Consent of Independent Registered Public Accounting Firm*
Power of Attorney (included on signature page hereto)*
Certification of Chief Executive Officer and Principal Financial Officer Required Under Rule 13a-14(a) and 15d-14(a) of
the Securities Exchanges Act of 1934, as amended.*
Certifications Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and to 18 U.S.C.
Section 1350.*
Exhibit No.
101.INS
XBRL Instance Document*
101.SCH XBRL Taxonomy Extension Schema*
101.CAL XBRL Taxonomy Extension Calculation Linkbase*
101.DEF XBRL Taxonomy Extension Definition Linkbase*
101.LAB XBRL Taxonomy Extension Label Linkbase*
101.PRE
XBRL Taxonomy Extension Presentation Linkbase*
Description
*
+
†
Filed herewith.
Designates management contracts and compensation plans.
This Exhibit has been filed separately with the Secretary of the Securities and Exchange Commission without the redaction
pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Corporate Information
2016 ANNUAL MEETING
The Annual Meeting of Stockholders will be held on August 17, 2016 at 9:00 a.m. local time at Green Acre Campus Pointe,
10300 Campus Point Drive, San Diego, CA, 92121.
BOARD OF DIRECTORS
Keith Murphy
Chairman of the Board
Chief Executive Officer
Robert Baltera, Jr.
Chief Executive Officer,
Hawkeye Therapeutics
James T. Glover
Former Chief Financial Officer,
Beckman Coulter, Inc.
Richard A. Heyman, Ph.D.
Former Chief Executive Officer,
Aragon Pharmaceuticals and
Seragon Pharmaceuticals
Tamar D. Howson
Former Senior Vice President of
Corporate and Business Development,
Lexicon Pharmaceuticals
Kirk Malloy, Ph.D.
Former Senior Vice President and
General Manager of Life Sciences,
Illumina
Eric Michael David, M.D., J.D.
Chief Strategy Officer and
Executive Vice President,
Preclinical Development
MANAGEMENT TEAM
Keith Murphy
Chairman of the Board
Chief Executive Officer
Sharon Collins Presnell, Ph.D.
Chief Scientific Officer
President, Samsara Sciences Inc.
Paul Gallant
General Manager
Jennifer Kinsbruner Bush, J.D.
General Counsel,
Corporate Secretary and
Compliance Officer
Susan Daugherty
Vice President,
Human Resources
GENERAL INFORMATION
INVESTOR INFORMATION
Transfer Agent and Registrar
Continental Stock Transfer and
Trust Company
17 Battery Place, 8th Floor
New York, NY 10004
(800) 509-5586
www.continentalstock.com
Independent Registered Public
Accounting Firm
Mayer Hoffman McCann P.C.
10616 Scripps Summit Court
San Diego, CA 92131
(858) 795-2000
www.mhmcpa.com
Stock Exchange
NYSE MKT
Common Stock (ONVO)
Information Requests
Copies of the Company’s Annual
Report on Form 10-K and other
investor information are available to
stockholders upon written request to:
Organovo Holdings, Inc.
Attention: Investor Relations
6275 Nancy Ridge Drive, Suite 110
San Diego, CA 92121
Investor Inquiries
Steve E. Kunszabo
Vice President, Investor Relations
and Corporate Communications
(858) 224-1092
ir@organovo.com
www.organovo.com
Organovo
6275 Nancy Ridge Drive, Suite 110
San Diego, CA 92121
(858) 224-1000
www.organovo.com
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Changing the shape of life science research and transforming medical care.
Organovo designs and creates functional human tissues using its proprietary 3D bioprinting technology. Organovo
builds living human tissues that are proven to function like native tissues. With reproducible 3D tissues that accurately
represent human biology, Organovo is enabling ground-breaking therapies. Organovo’s 3D human tissues have the
potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost.
Organovo also conducts early research on specific tissues for therapeutic use in direct surgical applications.
www.organovo.com
© Copyright 2016 Organovo Holdings, Inc. All rights reserved. Organovo is a registered mark of Organovo Holdings, Inc.
All other trademarks and service marks are the property of their respective holders. Information is subject to change without notice.