The document is ThermoGenesis Corp.'s annual report on Form 10-K for the fiscal year ended June 30, 2010. It provides information on the company's business overview, products, key events in fiscal 2010 including launching the Res-Q System and establishing global distribution for it, expanding distribution of existing products, and key management changes. It also discusses the regenerative medicine market opportunity and drivers of growth, ThermoGenesis' product offerings including the AXP and Res-Q Systems, and financial information and risks to the business.
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Thermogenesis 2010 annual report
1. UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended: June 30, 2010
Commission File Number: 333-82900
ThermoGenesis Corp.
(Exact name of registrant as specified in its charter)
Delaware 94-3018487
(State of incorporation) (I.R.S. Employer Identification No.)
2711 Citrus Road
Rancho Cordova, California 95742
(Address of principal executive offices) (Zip Code)
(916) 858-5100
(Registrant’s telephone number, including area code)
Securities Registered Pursuant to Section 12(b) of the Act: Common Stock, $0.001 par value Nasdaq Stock Market,
LLC 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 [X] No
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 [X] No
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 twelve 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.
[X] Yes [ ] No
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 the registrant’s knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any amendment of this Form 10-K. [ ]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer,
or a smaller reporting company. See the definitions of “large accelerated filer” and “small reporting company” in
Rule 12b-2 of the Exchange Act.
Large accelerated filer [ ] Accelerated filer [ ] Non-accelerated filer* [ ] Smaller reporting company [ X ]
*(Do not check if a smaller reporting company)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)
[ ] Yes [X] No
The aggregate market value of the common stock held by non-affiliates as of December 31, 2009 (the last trading
day of the second quarter) was $32,533,917, based on the closing sale price on such day.
As of September 13, 2010, 14,023,240 shares of the registrant’s Common Stock were outstanding.
DOCUMENTS INCORPORATED BY REFERENCE: Portions of the registrant’s proxy statement for its 2010
Annual Meeting of Stockholders are incorporated by reference into Part III hereof.
2. TABLE OF CONTENTS
Part I
Page Number
ITEM 1. Business ........................................................................................................................ 2
ITEM 1A. Risk Factors ................................................................................................................ 20
ITEM 1B. Unresolved Staff Comments ...................................................................................... 26
ITEM 2. Properties .................................................................................................................... 26
ITEM 3. Legal Proceedings ...................................................................................................... 27
ITEM 4. [Removed and Reserved] ........................................................................................... 27
Part II
ITEM 5. Market for the Registrant’s Common Equity and Related Stockholder Matters ........ 28
ITEM 6. Selected Financial Data .............................................................................................. 30
ITEM 7. Management’s Discussion and Analysis of Financial Condition and
Results of Operations ........................................................................................... 30
(a) Overview.............................................................................................................. 31
(b) Results of Operations ........................................................................................... 33
(c) Liquidity and Capital Resources .......................................................................... 36
ITEM 7A. Quantitative and Qualitative Disclosures about Market Risk .................................... 37
ITEM 8. Financial Statements and Supplementary Data .......................................................... 38
ITEM 9. Changes in and Disagreements with Accountants on Accounting
and Financial Disclosure ...................................................................................... 67
ITEM 9A. Controls and Procedures ............................................................................................. 67
ITEM 9B. Other Information ....................................................................................................... 67
Part III
ITEM 10. Directors, Executive Officers and Corporate Governance ......................................... 68
ITEM 11. Executive Compensation ............................................................................................ 68
ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters ................................................................................................... 68
ITEM 13. Certain Relationships and Related Transactions, and Director Independence ........... 68
ITEM 14. Principal Accounting Fees and Services .................................................................... 68
Part IV
ITEM 15. Exhibits and Financial Statement Schedules .............................................................. 69
Signatures ................................................................................................................... 73
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3. PART I
ITEM 1. BUSINESS
Business Overview
ThermoGenesis Corp. (“the Company”, “we”, “our”) mission is to design, develop and commercialize
medical products that enable the collection, processing and cryopreservation of stem cells and other
cellular tissues used in the practice of regenerative medicine. Regenerative medicine is an emerging field
which, among other things, aims to repair or restore lost or damaged tissue and cell function using cell-
based therapies. Our current products automate the volume reduction and cryopreservation process of
adult stem cell concentrates from cord blood and bone marrow for use in laboratory and point of care
settings. Our growth strategy is to expand our offerings in regenerative medicine and partner with other
pioneers in the stem cell arena to accelerate our worldwide penetration in this potentially explosive
market. We plan to have a product line that encompasses all sources of stem cells, including cord blood,
bone marrow, adipose, among others and to leverage our technological investments into profitable
adjacent markets, such as platelet rich plasma (“PRP”). The Company was founded in 1986 and is
located in Rancho Cordova, California.
Our business model is based on the sale of medical devices and the recurring revenues generated from the
companion single-use, sterile disposable products. We currently sell our products in 37 countries
throughout the world to customers that include private and public cord blood banks, surgeons, hospitals
and research institutions. Our worldwide commercialization strategy relies primarily on the utilization of
distributors.
Based upon early clinical results, there is accumulating evidence that many of the stem cell therapy trials
and clinical trials underway may result in approved therapies in disease states and tissue regeneration
procedures affecting significant patient populations, leading to a revolution in therapeutics involving stem
cells. Although understanding the full potential of cell therapies and their ultimate impact on the practice
of medicine remains a longer term prospect, we believe there are significant commercial opportunities in
the market today for technologies supporting stem cell research and cell-based treatments.
Our Solutions
We provide the tools necessary for the collection, separation, storage and delivery of stem cells from adult
tissue sources including cord blood and bone marrow, and potentially in the future, adipose and placenta.
These tools are being used by healthcare providers in both the laboratory and point of care settings. Our
competitive advantage is achieved through applying our advanced research and engineering capabilities to
develop a complete “tool box” for healthcare providers advancing regenerative medicine. Our solutions
enable our customers to automate their processes, comply with quality regulations and achieve high stem
cell yields. We believe our products significantly enhance the safety and viability of stem cell and
regenerative medical products and will ultimately expand the use and success of those products in clinical
treatment through their ease of use and high cell recovery rates.
Key Events and Accomplishments
The following are key events and accomplishments that occurred in fiscal 2010:
• Launch of Res-Q System
In July 2009, we launched the Res-Q™ 60 BMC (“Res-Q”) System, an automated cell processing
medical device for the concentration of bone marrow-derived stem cells at the point of care.
2
4. • Established Res-Q Distribution
We established global distribution for Res-Q, having signed agreements with distributors
covering four continents:
○ GE Healthcare (“GEHC”): Non-exclusive, U.S. excluding orthopedics, Canada and 19
European countries;
○ Celling Technologies: Orthopedic applications in North America (exclusive) and
worldwide (non-exclusive);
○ TotipotentSC: Exclusive for all fields of use (except orthopedics, non-exclusive) in
India, Malaysia and Thailand; and
○ CEI: Exclusive for all fields of use (except orthopedics, non-exclusive) in Mexico, and
Central and South American countries including Brazil, Chile, Columbia, Costa Rica,
Panama, Peru, Uruguay and Venezuela.
• Expanded Distribution of Existing Products
In keeping with our strategy to extend the distribution reach of our existing products, we
enhanced agreements in existing territories, added new territories and added new distributors:
○ GEHC - On February 4, 2010, we announced an improved distribution agreement with
GEHC for the AutoXpress™ or AXP® Platform (“AXP”). GEHC will provide
incremental funding for marketing support and market research beyond its previous
commitments.
○ Fenwal - In March 2010, we signed a new distribution agreement with Fenwal, Inc. to
market and distribute the AXP and BioArchive® systems in China, India and Japan.
• Key Management Changes
The following key management changes were made in fiscal 2010:
○ In August 2009, Harold Baker joined our Company and currently serves as Vice
President of Commercial Operations. Mr. Baker has more than two decades of global
sales and marketing experience in the healthcare sector, introducing new products,
leading teams in the cord blood stem cell market, managing distributor relationships
and building sales force organizations.
○ In October 2009, Jorge Artiles joined our Company as Vice President, Chief Quality
and Regulatory Affairs Officer. Mr. Artiles has more than two decades of quality and
regulatory affairs experience in the medical device industry, with expertise in quality
system development and compliance, project management and process optimization.
• Plan for CryoSeal® Fibrin Sealant System (“CryoSeal”) Product Line Divestiture
On June 16, 2010 we reached an agreement with Asahi Kasei Kuraray Medical Co., Ltd
(“Asahi”) in which Asahi paid us $1 million to provide CryoSeal products and clinical support
services until such time as Asahi assumes manufacturing of the product line in Japan or
December 31, 2012, whichever comes first. As part of the $1 million payment, we granted Asahi
an option to acquire the CryoSeal product line, which may be exercised over the next five years.
Recent significant event:
3
5. • Reverse Stock Split
On August 11, 2010, we announced that our board of directors had approved a 1-for-4 reverse
stock split of our common stock, pursuant to previously obtained stockholder authorization. The
reverse stock split, which became effective at the close of business on August 26, 2010, reduced
the number of shares of our common stock issued and outstanding from approximately 56.1
million to approximately 14 million. All share and per share amounts herein are presented on a
post-reverse-split basis.
Market Overview
The regenerative medicine market continues to experience meaningful advances in the clinical efficacy,
regulatory approval and product commercialization of cell based therapies. The vast majority of this
progress has been achieved through the application of adult stem cells, reflecting a greater awareness and
appreciation for the clinical value and safety of these cells in the research and medical communities.
Examples of clinical efficacy and regulatory approvals include:
• Approval of the first autologous cellular immunotherapy for the treatment of prostrate cancer;
• Positive results from a Phase II clinical trial to expand Mesenchymal Precursor Cells (“MPCs”)
from cord blood to reduce graft-versus-host disease;
• Expansion of treatments using cord blood beyond hematopoetic reconstitution;
• Favorable outcomes from the first human clinical trial of adipose tissue-derived stem and
regenerative cells for the treatment of heart attacks; and
• Positive results from a Phase I clinical trial of an allogeneic cell therapy product, administered to
individuals following acute myocardial infarction.
Examples of commercialization include:
• Expansion of orthopedic procedures using stem cells and orthobiologics.
• Growth of cord blood banking globally, especially in China.
Increasing positive results from the application of adult stem cells have resulted in greater government
and private sector investment in research and development of new cell therapies as well as the further
advancement of existing treatments. For example, in October of 2009, the California Institute of
Regenerative Medicine awarded $250 million in research grants to 14 universities and companies mainly
for adult stem cell research.
The regenerative medicine market is comprised of companies that either harvest, process, purify,
cryopreserve, store or administer stem cells. Key success factors include, among other things:
o Stem cell recovery rates
o Efficiency of cell processing
o Cost of care
o Product quality and efficacy
o Purity, viability and potency of stem cells
Cells are processed in the laboratory as well as in the operating room or point of care setting. Point of
care applications involve the processing of patient cells in conjunction with a surgical procedure in an
operating room or in an outpatient clinical setting. The laboratory market requirements include, but are
not limited to, Good Manufacturing Practices (“GMP”), objective quality assurance and the ability to
process multiple samples at one time. Requirements for the point of care include sterile field packaging,
4
6. portability, minimal processing steps and speed of processing. These market requirements must be
considered and translated into product features and benefits for successful market adoption.
The availability of stem cells at the point of care enables physicians to apply cells across an array of
applications. Physicians may also choose to study patient outcomes to understand the benefit of stem
cells under their own independently-sponsored and regulated studies. Such research efforts are growing
and already represent studies in diverse areas such as wound healing, radiation injury, breast
reconstruction and augmentation, cardiovascular applications, peripheral vascular disease and liver
disease among many others.
We expect the breadth of these applications will grow significantly as physicians continue to adopt cell-
based regenerative medicine into their treatment strategies based on the availability of safe, clinical grade
cells at the point of care.
Market Size
Market estimates for the regenerative medicine market include pathologies that affect vast numbers of
people of all age groups. A well known industry analyst, Robin Young, predicts the U.S. regenerative
medicine market will grow from $146.5 million in 2010 to over $8 billion by the year 2020. The
following chart highlights the disease states that are expected to be impacted by the advent of stem cell
therapies by the year 2020.
Dental Other
Diabetes
Anti‐
Inflammatory
Orthopedics/Spine
Nerve Repair
Cardiovascular
Industry Market Drivers
We expect a number of key market drivers to cause the practice of regenerative medicine to mature over
the next several years. As regenerative medicine matures, clinical studies and practice of medicine will
give way to broad clinical acceptance and substantial commercialization of cell based therapies.
We expect the following key market drivers to be the primary forces in the near future to positively
impact the growth of regenerative medicine:
• Political actions
• Government funding
• Clinical outcomes
• Corporate investment
5
7. • Awareness of availability
• Growing endorsement by doctors
• Increase in prevalence of conditions treated
• New sources of stem cells
Product Overview
We provide proprietary tools and technologies to enable highly effective separation and cryopreservation
of biological fluids including peripheral, bone marrow and umbilical cord blood at a competitive cost.
• The AXP is a medical device with an accompanying disposable bag set that isolates and retrieves
stem cells from umbilical cord blood. The AXP provides cord blood banks with an automated
system to enrich adult stem cells combined with lower labor costs and a reduced risk of
contamination under GMP conditions. The AXP product is an automated, closed, sterile system
that volume-reduces cord blood to a user defined volume in 30 minutes while retaining over 97%
of the mononuclear cells (“MNCs”). Self-powered and microprocessor-controlled, the AXP
contains flow control optical sensors that achieve precise separation.
Our market for the AXP includes both private and public cord blood banks. In private banks,
parents pay to preserve the cord blood cells from their offspring for family use, while a public
bank owns cord blood stem cells donated by individuals, which are then available to the public
for transplantation.
The AXP has been commercially available since 2006, marketed under a Master File with the
U.S. Food and Drug Administration (“FDA”). In 2007, we received 510(k) clearance from the
FDA for use in the processing of cord blood for cryopreservation.
Worldwide Cord Blood Banks Growth Rate
(Data Gathered by ThermoGenesis)
2005 2010 CAGR
Public Banks 118 176 8.3%
Private Banks 91 222 19.5%
Total Banks 209 398 13.7%
• The MarrowXpress™ or MXP™, an extension of the AXP, isolates and retrieves stem cells
from bone marrow aspirate and its initial application is for the preparation of cells for
regeneration of bone in spinal fusion procedures and tissues in cosmetic surgeries. The product is
an automated, closed, sterile system that volume-reduces blood from bone marrow to a user-
defined volume in 30 minutes, while retaining over 90% of the MNCs. Self-powered and
microprocessor-controlled, the MXP contains flow control optical sensors that achieve precise
separation. In June 2008, we received the CE-Mark, enabling commercial sales in Europe. In
July 2008, we received authorization from the FDA to begin marketing the MXP in the U.S. for
the preparation of cell concentrate from bone marrow.
• The Res-Q product is also used for bone marrow stem cell processing. Launched in July 2009,
the Res-Q can be used in a clinical laboratory or inter-operatively at the point of care. The
technology is a next generation, centrifuge-based disposable device designed for the isolation and
extraction of specific stem cell populations. Res-Q is a rapid, reliable, and easy-to-use product
6
8. which achieves a higher recovery rate of stem cells from bone marrow. The key advantages of
the Res-Q include (a) delivering a high number of target cells from a small sample of bone
marrow, and (b) providing a disposable that is highly portable and packaged for the sterile field.
These features allow the physician to process bone marrow and return the cells to the patient in as
little as 15 minutes. As cell processing for regenerative medicine applications becomes more
readily accepted, we believe the features and benefits of the Res-Q will position the product for
broad-based adoption.
• The BioArchive System is an automated cryogenic system used to cryopreserve and archive stem
cells for future transplant and treatment. Launched in fiscal 1998, over 200 BioArchive Systems
have been purchased by over 100 umbilical cord blood banks in over 33 countries to archive,
cryopreserve and store stem cell preparations extracted from human placentas and umbilical cords
for future use.
The BioArchive System is designed to store over 3,600 stem cell samples. It is the only fully-
automated, commercially available system that integrates controlled-rate freezing, sample
management and long term cryogenic storage in liquid nitrogen. The robotic storage and retrieval
of these stem cell units improves cell viability, provides precise inventory management and
minimizes the possibility of human error.
• The ThermoLine™ product line includes the ultra-rapid plasma ThermoLine Freezer and ultra-
rapid plasma ThermoLine Thawer. We offer two models of plasma freezers, which vary
primarily by capacity and condenser type. The ThermoLine freezer optimizes plasma freezing
through its unique liquid heat transfer and uniform freezing technologies that can freeze units of
blood plasma in approximately 30 minutes. These products are suited for medium to large
laboratories.
We also offer three models of blood component thawers which vary primarily by capacity. The
product’s unique flexible membrane technology allows for a closed thawing system. These
instruments can be used for rapid (less than 12 minute) homogeneous thawing of plasma and
glycerolized frozen red blood cells.
• The CryoSeal System is an automated system serving the wound market used to prepare an
autologous hemostatic surgical sealant from a patient’s own blood or from a single donor in
approximately one hour. We received a Premarket Approval (“PMA”) to market the CryoSeal in
liver resection surgeries in July 2007. On June 16, 2010 we reached an agreement with Asahi in
which Asahi paid us $1 million to provide CryoSeal products and clinical support services until
such time as Asahi assumes manufacturing of the product line in Japan or December 31, 2012,
whichever comes first. As part of the $1 million payment, we granted Asahi an option to acquire
the CryoSeal product line, which may be exercised over the next five years.
7
9. Sales and Distribution Channels
During fiscal 2010, we significantly expanded our distribution channels to include more geographies,
products and indications targeted by our products. This expansion took the form of new distributors,
improvements to existing distribution agreements and further leveraging our channels by granting rights
to distribute multiple products. See Item 1. Business/Business Overview.
The chart below outlines the distribution network for our products.
Product Distributor Region
U.S. and Canada, and approximately 30 countries
GEHC
throughout the world
CEI 9 countries in Latin America
AXP System
Fenwal, Inc. China, India, Japan
Delrus Russian Federation and CIS countries
ThermoGenesis All other countries
• U.S. orthopedic indications: Exclusive
Celling Technologies • Outside U.S. orthopedic indications: Non-
exclusive
Res-Q System U.S. (except orthopedics), Canada and 19
GEHC
European countries
9 countries in Latin America for indications
CEI
outside of orthopedics
TotipotentSC India, Malaysia and Thailand
Fenwal, Inc. China, India and Japan
CEI 5 countries in Latin America
BioArchive System Additional Distribution
10 Distributors covering over 30 countries
Network
All other countries including U.S., Canada and
ThermoGenesis
Australia
• U.S. orthopedic indications: Exclusive
Celling Technologies • Outside U.S. orthopedic indications: Non-
exclusive
MXP System 9 countries in Latin America for indications
CEI
outside of orthopedics
TotipotentSC India, Malaysia and Thailand
ThermoGenesis All other countries
8
10. Our sales by geographic region are as follows for the years ended June 30:
2010 2009 2008
U.S. $13,827,000 $11,489,000 $12,901,000
Asia 4,303,000 3,544,000 2,125,000
Europe 3,117,000 2,510,000 5,565,000
South America 1,405,000 1,859,000 1,208,000
Other 436,000 397,000 147,000
$23,088,000 $19,799,000 $21,946,000
9
11. Competition
Following are our major competitors, listed by each of our major products and disclosing the markets in
which they currently distribute competing products.
Competitors/Markets Area of Focus Geographic Distribution
AXP
BioSafe/Sepax • Processing of cord blood • Direct in Europe, Asia Pacific and U.S.
BioE/Prepacyte-cb • Modified manual processing of cord • Worldwide via local distribution
blood networks
MXP
BioSafe/Sepax • Laboratory processing of bone marrow • Direct in Europe, Asia Pacific and U.S.
aspirate
COBE/Spectra • Laboratory processing of bone marrow • Worldwide
aspirate
Ficoll/Paque • Manual processing of bone marrow • Worldwide distribution through GEHC
aspirate
Res-Q
Harvest/SmartPReP • Point of care and laboratory processing • U.S distribution through Oteotech, India
of bone marrow aspirate distribution through LifeCell, otherwise
direct
BioMet/MarrowStem • Point of care processing of bone marrow • Direct
aspirate
BioArchive
Chart • Cryopreservation of cells and tissue • Worldwide via local distribution
• BioRepository (Storage of cell lines, networks
primarily in vials)
• BioPharma (Storage of drugs or
vaccines, primarily in vials)
• Cord blood banks
Taylor Wharton • Cryopreservation of cells and tissue. • Worldwide via local distribution
• BioRepository networks
• BioPharma
• Cord blood banks
Thawers
Helmer • Blood banks, blood centers and hospital • Worldwide via Baxter in Europe.
blood banks Biotechnology Medical Services in the
Middle East, local distributors and direct
Thermo Fisher • Blood banks, blood centers and hospital • Worldwide
Scientific/Cyto Therm blood banks
Freezers
Harris • Source plasma companies and recovered • Worldwide via local distribution
plasma suppliers networks
Jewett • Source plasma companies and recovered • Worldwide via local distribution
plasma suppliers networks
10
12. Scientific Overview
Stem Cells
Stem cells have the remarkable potential to develop into many different cell types and serve as a repair
system for the body. They can theoretically divide without limit to replenish other cells as long as the
person or animal is alive. When a stem cell divides, each new cell has the potential to either remain a
stem cell or become another type of cell with a more specialized function, such as a muscle, a red blood,
or a brain cell.
There are two main types of stem cells: embryonic and adult. An embryonic stem cell is a primitive cell
derived from a 5-day pre-implantation embryo that has the potential to become a cell from a wide variety
of specialized cell types. Adult stem cells are found in human tissue and can renew and differentiate
themselves to yield the major specialized cell types of that tissue. Adult stem cells are thought to reside
in a specific area of each tissue where they may remain non-dividing for many years until they are
activated by disease or tissue injury. Our current products address therapies with adult stem cells only.
Initially, researchers’ greatest hope was for stem cells derived from embryos. However, while embryonic
stem cell therapies may offer great promise, it is unlikely that embryonic stem cell treatments will be
marketed for serious conditions for many years.
It is reported that stem cells can be found in umbilical cord blood, bone marrow, brain, peripheral blood,
fat, blood vessels, amniotic fluid, skeletal muscle, skin, placenta, menstrual blood and liver. Our products
have been used in cord blood and bone marrow applications. The technologies we are using for bone
marrow also have application in PRP procedures. We are currently evaluating opportunities for our
technology in the adipose (fat tissue) stem cell market.
Stem Cell Therapy
Adult stem cell research is primarily focused on the isolation, characterization, purity, plasticity and
clinical uses of adult-derived, pluripotent stem cells from a variety of human tissues. There are two
principal types of adult stem cells being investigated today for medical application: hematopoietic stem
cell and mesenchymal stem cells. Hematopoietic adult stem cells are capable of restoring the ability of a
patient’s bone marrow to produce healthy blood cells and are routinely used in the treatment of cancer.
Mesenchymal stem cells are being intensively investigated for their ability to promote healing of tissues
by modulation of inflammatory and immunologic responses and by promoting the growth of blood
vessels in ischemic (blood restricted) tissues.
Stem cell therapies include:
• Regenerating of bone marrow damaged by high-dose chemotherapy or radiation therapy used to
treat patients with a variety of cancers such as leukemia and lymphoma;
• Providing genetically healthy and functioning bone marrow to treat patients with more than 60 life
threatening genetic diseases such as sickle cell anemia and immunodeficiency; and
• Regenerating and repairing of tissue including the treatment of myocardial infarction, peripheral
limb ischemia and non-union bone fractures.
Perhaps the most important potential application of human stem cells is the generation of cells and tissues
that could be used for new regenerative medicine cell-based therapies. Today, donated organs and tissues
are often used to replace ailing or destroyed tissue, but the need for transplantable tissues and organs far
outweighs the available supply. Directed to differentiate into specific cell types, stem cells offer the
11
13. possibility of a renewable source of replacement cells and tissues that could possibly treat conditions
including spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.
Stem cell processing techniques are also capable of processing other cells including PRP for use in
orthopedics, cardio, dental and sports-related therapies.
Clinical Evaluations
We have the following Clinical Evaluations underway:
Product Indication Purpose Status
Celling Res-Q Spinal Fusion Full outcome, prospective The study is ready to
Technologies/ 30 patient study, one year begin
Spine Smith follow-up. Purpose of
study is comparing the
efficacy of three different
concentrations of MNCs
in spinal fusion
TotipotentSC Res-Q Critical Limb Pilot 15 patient limb Study to start
Ischemia (“CLI”) salvage study, one year September 2010
/Peripheral Artery follow-up. Purpose is to
Disorder (“PAD”) establish Res-Q
safety/efficacy for CLI
UC Davis Res-Q Non-Union Fractures 30 patient study, one year Study to start
follow-up, to establish September 2010
efficacy for Non-union
fractures
Naples MXP CLI 30 patient study, one year 15 patients enrolled. 9
follow-up to establish patients completed 2-
efficacy of bone marrow injection treatment. 4
treatment for CLI patients had six month
evaluation.
Research and Development
Our research and development activities are focused principally on the development of new products that
serve the regenerative medicine market and on significant upgrades to our existing products. Specific
activities in fiscal 2010 included launching our Res-Q product for bone marrow applications and
development of enhanced versions of our AXP device and companion disposable bag set. Activities
planned for fiscal 2011 include evaluation of our current technologies for PRP, further completion of
AXP second generation product enhancements and the development of a new BioArchive control box to
avoid obsolescence issues. Research and development expense reflects the cost of these activities, as well
as the costs to obtain regulatory approvals of new products and processes and to maintain the highest
quality standards with respect to existing products. We have no customer-sponsored research and
development expense.
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14. Manufacturing
Our long-term manufacturing strategy is to utilize high quality, low cost contract manufacturers to
provide the routine production of our products. The Company outsources the manufacture of the majority
of our disposable products. During fiscal 2010, we added an in-house pilot manufacturing capability to
ensure that initial production scale-up batches meet product requirements and manufacturability
standards. Also, we completed the manufacturing transfer of all ThermoLine products to our contract
manufacturer. Once the transfer was complete, we initiated cost reduction efforts in coordination with the
contract manufacturer. We continue to manufacture or assemble all of our other instruments and medical
devices. It is our intent to transition substantially all our device manufacturing to contract manufacturers
over the next few years. In conjunction with our outsourcing efforts and the eventual divestiture of our
surgical wound care business, we expect to streamline our supply chain and improve our order fulfillment
process through vendor consolidation and third party logistics providers.
The majority of the raw materials used to produce the Company’s products are readily available from a
variety of sources and, as such, the Company does not anticipate any shortage of supply. In the event it
becomes necessary to obtain raw materials from a new supplier, we would first be required to qualify the
quality systems and product of that alternative supplier.
Quality Strategy
Our quality strategy is now based on five key tenets:
• Doing things right the first time;
• Meeting customer expectations;
• Continuous improvement;
• Maintaining supplier controls; and
• Ensuring quality by design.
We embrace the notion that quality must be a key component of everything we do. Our management and
employees are measured and evaluated based on our quality performance. The foundation of our quality
strategy is our “quality system.”
Our quality system is based on a process approach to quality management. Any activity that receives
inputs and converts them to outputs is considered a quality process. We have identified and currently
manage numerous linked processes. Often the output from one process directly forms the input to the
next. Our quality system defines the parameters under which we conduct our business. The quality
system embeds our quality policy and describes how we will consistently provide our customers with
products and services that meet their expectations. Our quality system, and the obligations defined within
it, is applicable to all our suppliers, operating facilities, and functions. The principles embodied in our
quality system are viewed worldwide as a means of ensuring our products are produced in an acceptable
manner.
Our quality system has been created to be harmonized with domestic and international standards and is
focused to ensure it is appropriate for the specific devices we manufacture. Our corporate quality policies
govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging,
labeling, storage, installation, and servicing of all finished devices intended for human use. These
requirements are intended to ensure that finished devices will be safe and effective and otherwise in
compliance with the Federal Food, Drug, and Cosmetic Act administered by the FDA and the applicable
rules of other governmental agencies.
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15. We, as well as any contract manufacturers of our products, are subject to inspections by the FDA and
other regulatory agencies for compliance with applicable regulations, codified in the Quality System
Regulations (21 CFR 820) (“QSR”) which include requirements relating to manufacturing processes,
extensive testing, control documentation and other quality assurance procedures. Our facilities have
undergone International Organization of Standards (“ISO”) 13485:2003 and European Union Medical
Device Directive (93/42/EEC) (“MDD”) inspections and we have obtained approval to CE-Mark our
products. UL/CSA approval has also been obtained for our CryoSeal, BioArchive, MXP and AXP
products. We have obtained the CE-Mark for the Res-Q product line. Failure to obtain or maintain
necessary regulatory approvals to market our products would have a material adverse impact on our
business.
Over the last year, we improved our design process to better satisfy customer requirements and bolster
validation and verification of design outputs. We enhanced how we select and monitor our supplier base
to ensure components and products meet all relevant specifications.
Regulatory Strategy
Our regulatory strategy is to be involved in selective clinical programs that can generate data that will
help fuel adoption of our product offerings. We have a quality and regulatory compliance management
system that complies with the requirements of the ISO 13485: 2003 standard, the FDA’s QSR, the
European Union MDD, the Canadian Medical Device Regulations (“SOR 98-282”), and other applicable
local, state, national and international regulations.
Our medical devices are subject to regulation by numerous government agencies, including the FDA and
comparable foreign agencies. To varying degrees, each of these agencies requires us to comply with laws
and regulations governing the development, testing, manufacturing, labeling, marketing, distribution,
installation and servicing of our research, investigational, and commercially-distributed medical devices.
These international, national, state, and local agencies set the legal requirements for ensuring our products
are safe and effective. Virtually every activity associated with the manufacture and sale of our products
and services are scrutinized on a defined basis and failure to implement and maintain a Quality
Management System could subject the Company to civil and criminal penalties.
Class III Devices
Before certain medical devices may be marketed in the U.S., they must be approved by the FDA. FDA
approval depends on the classification of the device. If the product is a Class III device, such as the
CryoSeal System, the FDA approval process includes the following:
• Extensive pre-clinical laboratory and animal testing;
• Submission and approval of an Investigational Device Exemption (“IDE”) application;
• Human clinical trials (Phase III) to establish the safety and efficacy of the medical device for the
intended indication; and
• Submission and approval of a PMA to the FDA.
Pre-clinical trials include laboratory evaluation, through in vitro and in vivo animal studies, to obtain
safety and dosage information about the product to justify future clinical trials in human subjects. Safety
testing is performed to demonstrate the biocompatibility of the device, particularly if the device is
intended to come into contact with blood or other body tissues. Pre-clinical studies must be performed by
laboratories which comply with the FDA’s Good Laboratory Practices regulations. The results of the pre-
clinical studies are submitted to the FDA as part of an IDE application and are reviewed by the FDA
before human clinical trials can begin.
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16. Clinical trials involve the application of the medical device or biologic produced by the medical device to
patients by a qualified medical investigator, after approval from an Institutional Review Board (“IRB”).
Clinical trials are conducted in accordance with FDA Good Clinical Practice regulations, standards
developed by the International Conference on Harmonization (“ICH”), and an approved study protocol
that details the objectives of the study, the parameters to be used to monitor participant safety and
effectiveness of the product, or other criteria to be evaluated. Each protocol is submitted to the FDA as
part of the IDE and each clinical study is conducted only after the approval of the IRB. The IRB
considers, among other things, ethical factors, the potential risks to subjects participating in the trial, and
the possible liability of the institution. The IRB also approves the consent form signed by the study
participants.
Medical device clinical trials are typically conducted as a Phase III clinical trial. A Phase II safety pilot
trial may be performed prior to initiating the Phase III clinical trial to determine the safety of the product
for specific targeted indications or dosage optimization studies. The FDA, the clinical trial sponsor, the
investigators or the IRB may suspend clinical trials at any time if any one of them believes that study
participants are being exposed to an unacceptable health risk.
The combined results of product development, pre-clinical studies, and Phase III clinical studies are
submitted to the FDA as a PMA for approval of the marketing and commercialization of the medical
device in the U.S. The FDA may deny the approval of a PMA if applicable regulatory criteria are not
satisfied or it may require additional clinical testing. Even if the appropriate data is submitted, the FDA
may ultimately decide the PMA does not satisfy the criteria for approval. Product approvals, once
obtained, may be withdrawn if compliance with regulatory standards is not maintained or if safety
concerns arise after the product reaches the market. The FDA may require post-marketing testing and
surveillance programs to monitor the effect of the medical devices that have been commercialized and has
the power to prevent or limit future marketing of the product based on the results of such programs.
Class II Devices
Several of our medical devices, such as the BioArchive and AXP are categorized as Class II. These
devices have a lower potential safety risk to the patient, user, or caregiver. A PMA submission is not a
requirement for these devices. A similar (but simpler and shorter) process of premarket notification,
known as a 510(k) submission, is required to demonstrate that the device is as safe and effective as a
substantially equivalent medical device that has been legally marketed in the U.S. prior to May 29, 1976.
Once the FDA has notified the Company that the product file has been cleared, the medical device may be
marketed and distributed in the U.S.
Class I Devices
Some of our products, such as MXP and Res-Q that have minimal risk to the intended user are deemed by
the FDA as being exempt from FDA approval or clearance processes. While submissions to the Agency
are not a requirement for these Class I (low risk) devices, compliance with the QSR is still mandated.
Other U.S. Regulatory Information
Failure to comply with applicable FDA requirements can result in fines, injunctions, civil penalties, recall
or seizure of products, total or partial suspension of production or loss of distribution rights. It may also
include the refusal of the FDA to grant approval of a PMA or clearance of a 510(k). Actions by the FDA
may also include withdrawal of marketing clearances and possibly criminal prosecution. Such actions, if
taken by the FDA, could have a material adverse effect on the Company’s business, financial condition,
and results of operation.
In February of 2008, the Company initiated a voluntary recall for its AXP processing bag sets. The
product was recalled as a result of the omission of endotoxin testing during lot release testing. The
15
17. Company developed a process, with the approval of the FDA and other regulatory agencies, to assess
each manufactured lot and perform the appropriate testing. To date, all but one lot have been
“reconditioned” through the testing process and samples remain to be obtained for the final lot before the
recall can be completed and closed. Although this recall remains open a recall closure request has been
submitted to the FDA. FDA response to our recall closure request is pending.
Each manufacturing establishment must be registered with the FDA and is subject to a biennial inspection
for compliance with the Federal Food, Drug, and Cosmetic Act and the QSRs. In addition, each
manufacturing establishment in California must be registered with the California State Food and Drug
Branch of the California Department of Public Health and be subject to an annual inspection by the State
of California for compliance with the applicable state regulations. Companies are also subject to various
environmental laws and regulations, both within and outside the U.S. Our operations involve the use of
substances regulated under environmental laws, primarily manufacturing and sterilization processes.
Workplace safety, hazardous material, and controlled substances regulations also govern our activities.
The Company has a California Environmental Protection Agency Identification number for the disposal
of biohazardous waste from its research and development biological lab.
International Regulatory Requirements
Internationally, we are required to comply with a multitude of other regulatory requirements. To legally
market our medical devices in Canada, for example, we fall under the auspices of Health Canada and the
Canadian Medical Device Regulations. Health Canada reviews medical devices to assess their safety,
effectiveness, and quality before allowing them to be authorized for sale in Canada. The Therapeutic
Products Directorate (“TPD”) undertakes a variety of activities, including the promulgation of policies
and regulations to support its role as the federal regulatory authority for the sale of medical devices in
Canada. In Canada, manufacturers must receive a medical device license for certain health products
defined as a "device" under the Canadian Food and Drugs Act before they can be sold on the Canadian
market. To determine which devices need a license, medical devices are categorized based on the risks
associated with their use. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices
must obtain a medical device license. Although Class I devices do not require a license, manufacturers,
distributors, and importers are required to obtain an establishment license. Health Canada requires
medical device manufacturers to use a quality system certificate as evidence of compliance to the
appropriate regulatory quality system requirement and Health Canada will only accept quality system
certificates that have been issued by special third party recognized auditing organizations (registrars)
under the Canadian Medical Devices Conformity Assessment System (“CMDCAS”). The Medical
Devices Regulations require class II, III and IV medical devices to be designed and/or manufactured
under ISO 13485:2003.
In the European Union, a single regulatory approval process has been created and approval is represented
by the CE-Mark. To be able to affix the CE-Mark to our medical devices and distribute them in the
European Union, we must meet minimum standards for safety and quality (known as the essential
requirements) and comply with one or more conformity rules. A Notified Body assesses our quality
management system and compliance to the MDD.
To be sold in Japan, most medical devices must undergo thorough safety examinations and demonstrate
medical efficacy before they can be granted approval (known as “shonin”). The Japanese government,
through the Ministry of Health, Labor, and Welfare (“MHLW”) regulates medical devices under the
Pharmaceutical Affairs Law (“PAL”).
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18. Patents and Proprietary Rights
The Company believes that patent protection is important for products and potential segments of its
current and proposed business. In the U.S., the Company currently holds 22 patents, and has three patents
pending to protect the designs of products which the Company intends to market. There can be no
assurance, however, as to the breadth or degree of protection afforded to the Company or the competitive
advantage derived by the Company from current patents and future patents, if any. Although the
Company believes that its patents and the Company’s existing and proposed products do not infringe
upon patents of other parties, it is possible that the Company’s existing patent rights may be challenged
and found invalid or found to violate proprietary rights of others. In the event any of the Company’s
products are challenged as infringing, the Company would be required to modify the design of its product,
obtain a license or litigate the issue. There is no assurance that the Company would be able to finance
costly patent litigation, or that it would be able to obtain licenses or modify its products in a timely
manner. Failure to defend a patent infringement action or to obtain a license or implementation of
modifications would have a material adverse effect on the Company’s continued operations.
While patents have been issued or are pending, the Company realizes, (a) that the Company will benefit
from patents issued only if it is able to market its products in sufficient quantities of which there is no
assurance; (b) that substitutes for these patented items, if not already in existence, may be developed; (c)
that the granting of a patent is not a determination of the validity of a patent, such validity can be attacked
in litigation or the Company or owner of the patent may be forced to institute legal proceedings to enforce
validity; and (d) that the costs of such litigation, if any, could be substantial and could adversely affect the
Company.
Licenses and Distribution Rights
Asahi
In June 2010, the Company and Asahi entered into an amendment (the "Amendment") of their
Distribution and License Agreement, originally effective March 28, 2005. Under the terms of the
Amendment, Asahi will obtain exclusive rights to distribute the CryoSeal System (“Products”) in South
Korea, North Korea, Taiwan, the Peoples Republic of China, the Philippines, Thailand, Singapore, India
and Malaysia. These rights shall include the exclusive right to market, distribute and sell the processing
disposables and Thrombin Reagent for production of thrombin in a stand alone product. The Company
will provide support to Asahi in the form of maintaining manufacturing capabilities of the CryoSeal
System products until the earlier of when Asahi receives regulatory approval from the MHLW or
December 31, 2012, upon which the Company shall have no further obligation to manufacture the
Products. Asahi shall continue to have the right to manufacture such Products in Japan and shall
additionally have a non-exclusive right to manufacture such Products outside of Japan and would make
royalty payments to the Company for Products it manufactures and sells. The Amendment extends the
agreement eight years with automatic one year renewals. Asahi paid us a $1,000,000 license fee, of
which $400,000 is refundable if the Company fails to provide technical support or maintain
manufacturing capabilities as specified in the Amendment.
In connection with the above-described Amendment, the Company and Asahi also entered into an Option
Agreement ("Option Agreement"). Under the terms of the Option Agreement, the Company granted
Asahi an option to purchase certain intellectual property rights of the Company related to the CryoSeal
System, including, but not limited to, patents and patent applications, FDA-PMA ownership relating to
the products and certain related contracts and contractual relationships. Asahi may exercise the Option
Agreement at any time after the effective date of the Amendment, but no later than the earlier of the fifth
anniversary of the Amendment or 90 days after receiving regulatory approval from the MHLW.
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19. Cord Blood Registry Systems, Inc. (“CBR”)
In June 2010, the Company and CBR entered into a License and Escrow Agreement as a method to
provide assurances to CBR of continuity of product delivery and manufacturing for CBR’s business, and
to alleviate concerns about long term supply risk. We are the sole provider for CBR of devices and
disposables used in the processing of cord blood samples in CBR’s operations. Under the agreement, the
Company granted CBR a non-exclusive, royalty-free license to certain intellectual property necessary for
the potential manufacture and supply of AXP devices and certain AXP disposables. The license is for the
sole and limited purpose of manufacturing and supplying the AXP and related disposables for use by
CBR. The licensed intellectual property will be maintained in escrow and will be released to and used by
CBR if and only if the Company defaults under the Agreement. Default occurs if the Company (1) fails
to meet certain positive cash flow metrics for each rolling quarterly measurement period beginning
December 31, 2010, except where the following two measures are met, (2) failure to meet cash balance
and short-term investments of at least $6 million at the end of any given month, or (3) failure to meet a
quick ratio of 2 to 1 at the end of any given month.
GEHC
In May 2010, the Company and GEHC signed a non-exclusive distribution agreement for the Res-Q
System. Under the agreement, GEHC has the right to distribute the Res-Q in the U.S. excluding
orthopedic indications, Canada and 19 European countries. The agreement has a two and a half year
term, with automatic one year renewals, unless terminated by either party with six months advance notice.
The Agreement provides for a price reduction mechanism should the Company fail to meet certain
product quality and delivery metrics.
In January 2010, the Company and GEHC also signed an amendment (the "Amendment") of their
Amended and Restated International Distribution Agreement, effective February 1, 2010. Under the terms
of the Amendment, the initial term runs through July 31, 2012, GEHC will continue to distribute the AXP
product line in the United States, Canada and approximately 30 countries throughout the world, excluding
certain countries in Latin America, Asia, CIS, Eastern Europe and the Middle East. The parties will
implement a joint operating committee to oversee, review and coordinate marketing and sales activities
and performance of the parties. GEHC will provide incremental funding for marketing support and
market research beyond its previous commitments. The Amendment provides incentives for both parties
related to sales success, product quality and delivery. The Amendment will automatically renew for one
year terms unless terminated at least six months prior to the end of the then current term. Under the
original agreement, signed October 13, 2005, the Company received fees for the rights granted under the
agreement. The amounts received are being recognized as revenue on the straight-line method over the
initial five year term of the contract.
Fenwal
In March 2010, the Company and Fenwal, Inc. signed a five year distribution agreement. Under the
agreement, Fenwal will have exclusive rights to market and distribute the AXP System and BioArchive
System for use in cord blood processing and storage in China, India and Japan.
Celling Technology
In September 2008, the Company and Celling Technology signed a distribution agreement for the
Company’s MXP and Res-Q product lines. The distribution rights are for the field of use in orthopedic
intraoperative or point of care applications. The five year agreement provides Celling with an initial two
year period of exclusive distribution rights in the U.S. and non-exclusive distribution rights throughout
the rest of the world, excluding Central and South America, Russia and certain Eastern European
countries. The exclusivity period and field of use may be extended under certain circumstances. The
parties amended the agreement on July 29, 2009 to provide shared funding for clinical studies to
demonstrate the clinical effectiveness of the products in orthopedic applications.
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20. CBR
On August 22, 2006, the Company announced that GEHC and CBR, the world’s largest family cord
blood bank, signed a multi-year contract to supply CBR with the Company’s AXP Platform and
disposables. In conjunction with this agreement, the Company signed a Product Development and Supply
Assurance Agreement with CBR which assures the supply of AXP products for a 15 year period. This
agreement also initiates the development of an advanced cord blood stem cell container.
Biomet
In July 2006, the Company entered into a Product Development and Supply Agreement with Biomet.
Under the development phase of this agreement, Biomet paid the Company $1.1 million in milestone
payments to develop a fibrinogen concentration kit. The Company will grant intellectual property license
rights to Biomet and its affiliates to manufacture, use and sell the product for use in surgical hemostats,
graft delivery systems and surgeries. The Company has the right of first offer to manufacture the product;
and if the Company does not manufacture the product, Biomet will pay a royalty. The agreement has a
term of five years.
New York Blood Center (“NYBC”)/Pall Medical
In March 1997, the Company and NYBC, as licensors, entered into a license agreement with Pall
Medical, a subsidiary of Pall Corporation, as a Licensee through which Pall Medical became the
exclusive worldwide manufacturer (excluding Japan) for a system of sterile, disposable containers
developed by the Company and NYBC for the processing of hematopoietic stem cells sourced from
placental cord blood (“PCB”). The system is designed to simplify and streamline the harvesting of stem
cells from umbilical cord blood and the manual concentration, cryopreservation (freezing) and transfusion
of the PCB stem cells while maintaining the highest stem cell population and viability from each PCB
donation. In May 1999, the Company and Pall Medical amended the original agreement, and the
Company regained the rights to distribute the bag sets outside North America and Europe under the
Company’s name, and in May 2000, the Company negotiated rights to directly co-market the bag sets in
Europe in exchange for an additional royalty fee, while continuing to utilize Pall Europe’s distribution
centers.
Backlog
Our backlog was $600,000 and $500,000 as of June 30, 2010 and 2009, respectively. Our backlog
consists of product orders for which a customer purchase order has been received and is scheduled for
shipment within the next twelve months. Orders are subject to cancellation or rescheduling by the
customer, sometimes with a cancellation charge. Due to timing of order placement, product lead times,
changes in product delivery schedules and cancellations, and because sales will often reflect orders
shipped in the same quarter received, our backlog at any particular date is not necessarily indicative of
sales for any succeeding period.
Employees
As of June 30, 2010, the Company had 76 employees, 31 of whom were engaged in manufacturing and
quality control, 19 in research and new product development, regulatory affairs, clinical and scientific
affairs, 12 in sales, marketing and customer service, and 14 in administration. The Company also utilizes
temporary employees throughout the year to address business needs and significant fluctuations in orders
and product manufacturing. None of our employees are represented by a collective bargaining agreement,
nor have we experienced any work stoppage.
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21. FOREIGN SALES AND OPERATIONS
For fiscal year 2010, foreign sales were $9,261,000 or 40% of net revenues. For fiscal year 2009, foreign
sales were $8,310,000 or 42% of net revenues. For fiscal year 2008, foreign sales were $9,045,000 or
41% of net revenues.
Our second-source bag set supplier manufactures the AXP bag sets in Costa Rica.
WHERE YOU CAN FIND MORE INFORMATION
The Company is required to file annual reports on Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8-K and other information with the Securities and Exchange Commission (“SEC”). The
public can obtain copies of these materials by visiting the SEC’s Public Reference Room at 100 F Street,
NE, Room 1580, Washington, DC 20549, by calling the SEC at 1-800-732-0330, or by accessing the
SEC’s website at http://www.sec.gov. In addition, as soon as reasonably practicable after these materials
are filed with or furnished to the SEC, the Company will make copies available to the public free of
charge through its website, www.thermogenesis.com. The information on the Company’s website is not
incorporated into, and is not part of, this annual report.
ITEM 1A. RISK FACTORS
An investment in ThermoGenesis’ common stock is subject to risks inherent to our business. The
material risks and uncertainties that management believes affect us are described below. Before making
an investment decision, you should carefully consider the risks and uncertainties described below together
with all of the other information included or incorporated by reference in this report. The risks and
uncertainties described below are not the only ones facing ThermoGenesis. Additional risks and
uncertainties that management is not aware of or focused on or that management currently deems
immaterial may also impair ThermoGenesis’ business operations. This report is qualified in its entirety
by these risk factors.
If any of the following risks actually occur, our financial condition and results of operations could be
materially and adversely affected. If this were to happen, the value of our common stock could decline
significantly, and you could lose all or part of your investment.
Risks Related to Our Business
Our New Products Are at Initial Market Introduction, and We Are Not Sure the Market Will Accept Them.
The market acceptance of our new products will depend upon the medical community and third-party
payers accepting the products as clinically useful, reliable, accurate, and cost effective compared to
existing and future products or procedures. Market acceptance will also depend on our ability to
adequately train technicians on how to use the MXP and Res-Q Systems and future products. Even if our
new products are released for sale, their use may not be recommended by the medical profession or
hospitals unless acceptable reimbursement from healthcare and third party payers is available. Failure of
these new products to achieve significant market share could have material adverse effects on our long
term business, financial condition, and results of operation.
A Significant Portion of our Revenue is Derived from Customers in Foreign Countries. We may Lose
Revenues, Market Share, and Profits due to Exchange Rate Fluctuations, Political and Economic
Changes related to our Foreign Business. In the year ended June 30, 2010, sales to customers in foreign
countries comprised approximately 40% of our revenues. This compares to 42% in fiscal 2009. Our
foreign business is subject to economic, political and regulatory uncertainties and risks that are unique to
each area of the world. Fluctuations in exchange rates may also affect the prices that our foreign
customers are willing to pay, and may put us at a price disadvantage compared to other competitors.
Potentially volatile shifts in exchange rates may negatively affect our financial position and results.
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22. Outcomes of Pending or Future Clinical Trials May be Negative and the Regenerative Medicine Market
May not Expand, or May Not Expand in the Areas Targeted by our Products. The marketing and sales of
new products may depend on successful clinical trial outcomes in the regenerative medicine areas
targeted by our products and the approval of regulators. Clinical trials also represent a significant
expenditure of resources. Negative clinical trial results in connection with our products or in the areas
targeted by the Company could negatively impact regulatory approval or market acceptance of our
products. Failure to attain successful clinical trials, to obtain regulatory approval, or to target areas with
successful clinical trials could have material adverse effects on our long term business, financial
condition, and results of operation
Risks Related to Our Operations
Our Inability to Protect Our Patents, Trademarks, Trade Secrets and Other Proprietary Rights could
Adversely Impact Our Competitive Position. We believe that our patents, trademarks, trade secrets and
other proprietary rights are important to our success and our competitive position. Accordingly, we
devote substantial resources to the establishment and protection of our patents, trademarks, trade secrets
and proprietary rights. We use various methods, including confidentiality agreements with employees,
vendors, and customers, to protect our trade secrets and proprietary know-how for our products. We
currently hold patents for products, and have patents pending for additional products that we market or
intend to market. However, our actions to establish and protect our patents, trademarks, and other
proprietary rights may be inadequate to prevent imitation of our products by others or to prevent others
from claiming violations of their trademarks and proprietary rights by us. If our products are challenged
as infringing upon patents of other parties, we may be required to modify the design of the product, obtain
a license, or litigate the issues, all of which may have an adverse business effect on us.
Any Failure to Achieve and Maintain the High Design and Manufacturing Standards that our Products
Require may Seriously Harm our Business. Our products require precise, high-quality manufacturing.
Achieving precision and quality control requires skill and diligence by our personnel as well as our
vendors. Our failure to achieve and maintain these high manufacturing standards, including the incidence
of manufacturing errors, design defects or component failures, could result in patient injury or death,
product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other
problems that could seriously hurt our business. Additionally, the large amount of AXP disposable
inventory certain distributors and end-users maintain may delay the identification of a manufacturing
error and expand the financial impact. A manufacturing error or defect, or previously undetected design
defect, or uncorrected impurity or variation in a raw material component, either unknown or undetected,
could affect the product. Despite our very high manufacturing standards, we cannot completely eliminate
the risk of errors, defects or failures. If we or our vendors are unable to manufacture our products in
accordance with necessary quality standards, our business and results of operations may be negatively
affected.
We are Dependent on our Suppliers and Manufacturers to Meet Existing Regulations. Certain of our
suppliers and manufacturers are subject to heavy government regulations, including FDA QSR
compliance, in the operation of their facilities, products and manufacturing processes. Any adverse action
by the FDA against our suppliers or manufacturers could delay supply or manufacture of component
products required to be integrated or sold with our products. There are no assurances we will be
successful in locating an alternative supplier or manufacturer to meet product shipment or launch
deadlines. As a result, our sales, contractual commitments and financial forecasts may be significantly
affected by any such delays.
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23. Dependence on Suppliers for Disposable Products and Custom Components May Impact the Production
Schedule. The Company obtains certain disposable products and custom components from a limited
number of suppliers. If the supplier raises the price or discontinues production, the Company may have to
find another qualified supplier to provide the item or re-engineer the item. In the event that it becomes
necessary for us to find another supplier, we would first be required to qualify the quality assurance
systems and product quality of that alternative supplier. Any operational issues with re-engineering or the
alternative qualified supplier may impact the production schedule, therefore delaying revenues, and this
may cause the cost of disposables or key components to increase.
Our Products May Be Subject to Product Recalls which May Harm Our Reputation and Divert Our
Managerial and Financial Resources. The FDA and similar governmental authorities in other countries
have the authority to order the mandatory recall of our products or order their removal from the market if
the governmental entity finds our products might cause adverse health consequences or death. The FDA
may also seize product or prevent further distribution. A government-mandated or voluntary recall by us
could occur as a result of component failures, manufacturing errors or design defects (including labeling
defects). In the past we have initiated voluntary recalls of some of our products and we could do so in the
future. Any recall of our products may harm our reputation with customers, divert managerial and
financial resources and negatively impact our profitability.
Quality Problems with our Products or Processes could Harm our Reputation for Producing High
Quality Products and Decrease our Future Revenues. Quality is extremely important to us and to our
customers due to the consequences of product failure. Our quality certifications and product performance
during evaluations and validations are critical to the marketing success of our products. If we fail to meet
our customer’s quality standards our reputation could be damaged. We could lose current and potential
customers and our future revenues could decline as a result.
All of our Operations are Conducted at a Single Location. Any Disruption at our Facility could Delay
Revenues or Increase our Expenses. All of our operations are conducted at a single location although we
contract the manufacturing of certain devices, disposables and components. We take precautions to
safeguard our facility, through insurance, health and safety protocols, and off-site storage of computer
data. However, a natural disaster, such as a fire, flood or earthquake, could cause substantial delays in
our operations, damage or destroy our manufacturing equipment or inventory, and cause us to incur
additional expenses. The insurance we maintain against fires, floods, and other natural disasters may not
be adequate to cover our losses in any particular case.
We are Heavily Reliant on a Single Distributor to Market and Sell our AXP Products. GEHC is the
primary distributor of the AXP Platform. We have limited control over their sales and marketing efforts
for these products. Although we have added distributors in other territories, we must manage our
distribution network effectively. Since the AXP Platform products are a significant portion of our
revenues and projected revenue growth, a delay or failure by our distributor to successfully market these
products may decrease our future revenues and competitive advantage.
We are Heavily Reliant on a Single Distributor to Market and Sell our MXP and Res-Q Products.
Currently, Celling Technologies is the primary distributor of our MXP and Res-Q products. For
orthopedic applications, Celling Technologies has exclusive distribution rights in the U.S. and non-
exclusive rights in the rest of the world. Although we have added distributors in other territories and for
other indications, we must manage our distribution network effectively to gain additional revenue and
gross profit. We have limited control over our distributor’s sales and marketing efforts for these products.
A delay or failure by our distributors to successfully market these products may decrease our revenues
and competitive advantage.
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24. Our Business is Indirectly Subject to Customer and Distributor Inventory Requirements and Continuity of
Inventory Purchasing. Our end user customers may have separate agreements with our distributors that
require them to hold a certain level of inventory. Similarly, other customers have historically purchased
ahead of their utilization to insure growth within their business, particularly for the processing of stem
cells. Given the tightening of credit and other financial constraints, including possible downturns in
collection and processing for cord blood, our customers could reduce the amount of inventory levels our
distributors hold, or which they hold internally in lieu of new purchases. If that were to occur, sales of our
products could decline significantly, which would have a material adverse effect on our financial
performance in any period where such events occur.
Failure to Meet the Quality and Delivery Metrics specified in the GEHC Distribution Agreements could
Decrease our Revenues. Under the AXP and Res-Q distribution agreements with GEHC, if we fail to
meet certain quality and delivery metrics, the price paid by GEHC will be reduced in the following
quarter. If this were to occur, our revenues would be negatively impacted.
Failure to Meet Certain Financial Covenants could Decrease our AXP Revenues. Under the CBR license
and escrow agreement, if we fail to meet certain financial covenants, CBR may take possession of the
escrowed intellectual property and initiate manufacturing of the AXP device and disposables for their
own use. If this were to occur, our revenues would be negatively impacted.
Failure to Retain or Hire Key Personnel May Adversely Affect Our Ability to Sustain or Grow Our
Business. Our ability to operate successfully and manage our potential future growth depends
significantly upon retaining key research, technical, clinical, regulatory, sales, marketing and managerial
personnel and attracting and retaining highly qualified personnel in these areas. Our future success
partially depends upon the continued services of key technical and senior management personnel. Our
future success also depends on our continuing ability to attract, retain and motivate highly qualified
managerial and technical personnel. The inability to retain or attract qualified personnel could have a
significant negative effect upon our efforts and thereby materially harm our business and future financial
condition.
Risks Related to Operating Results and Financial Markets
We Have Incurred Net Losses since Our Inception and Losses May Continue. Except for net income of
$11,000 for fiscal 1994, we have not been profitable since our inception. For the fiscal year ended June
30, 2010, we had a net loss of $5,193,000 and an accumulated deficit at June 30, 2010, of $103,552,000.
We will continue to incur significant costs as we develop and market our current products and related
applications. Although we are executing on our business plan to develop and market launch new
products, continuing losses may impair our ability to fully meet our objectives for new product sales.
We May Need to Raise Additional Capital in the Future to Fund Our Operations. We May be Unable to
Raise Funds When Needed or on Acceptable Terms. During the year ended June 30, 2010, our operating
activities used cash of $4,428,000. As of June 30, 2010, we had a cash balance of $10,731,000. Based on
our cash balance, historical trends, planned cost reductions and future revenue projections, we believe our
current funds are sufficient to provide for our projected needs to maintain operations and working capital
requirements for at least the next 12 months. However, if actual sales do not meet expectations, or
product development, marketing and production costs increase significantly, we may need to seek
additional financing beyond the next 12 months. We may also raise money for strategic initiatives which
may be dilutive. Any additional equity financings may be dilutive to our existing stockholders.
The Continuing Crisis in the U.S. and World Financial and Securities Markets Could Have a Material
Adverse Effect on our Customers’ Business and Effect our Operations and Revenues. Our products are
purchased by cord blood banks and hospitals. We believe these entities have been negatively affected by
23
25. the deterioration in the U.S. and global economies in several ways. For instance, cord blood banks and
hospitals are facing increased pressure from reduction in donations or in government funding that support
their operations. The current economic crisis heightens the risk that our customers may lack the funding
or credit facilities that they may have previously used for acquiring our products. Such credit or funding
restrictions could delay or lower our future revenues.
The Preparation of our Consolidated Financial Statements in Accordance with U.S. Generally Accepted
Accounting Principles Requires Us to Make Estimates, Judgments, and Assumptions that may Ultimately
Prove to be Incorrect. The accounting estimates and judgments that management must make in the
ordinary course of business affect the reported amounts of assets and liabilities at the date of the
consolidated financial statements and the reported amounts of revenue and expenses during the periods
presented. If the underlying estimates are ultimately proven to be incorrect, subsequent adjustments could
have a material adverse effect on our operating results for the period or periods in which the change is
identified. Additionally, subsequent adjustments could require us to restate our consolidated financial
statements. Restating consolidated financial statements could result in a material decline in the price of
our stock.
We and our Customers are Subject to Various Political, Economic and Regulatory Changes in the
Healthcare Industry that Could Force us to Modify how we Develop and Price our Components,
Manufacturing Capabilities and Services, and could Harm our Business. The healthcare industry is
highly regulated and is influenced by changing political, economic and regulatory factors. Federal and
state legislatures have periodically considered programs to reform or amend the U.S. healthcare system at
both the federal and state levels. Regulations affecting the healthcare industry in general, and the medical
device industry in particular, are complex, change frequently and have tended to become more stringent
over time. In addition, these regulations may contain proposals to increase governmental involvement in
healthcare, lower reimbursement rates or otherwise change the environment in which healthcare industry
participants, including medical device companies, operate. While we are not aware of any legislation or
regulations specifically targeting the medical device industry that are currently pending, any such
regulations could impair our ability to operate profitably. In addition, any failure by us to comply with
applicable government regulations could also result in the cessation of portions or all of our operations,
impositions of fines and restrictions on our ability to continue or expand our operations.
Risks Related to Our Industry
Our Business is Heavily Regulated, Resulting in Increased Costs of Operations and Delays in Product
Sales. Many of our products require FDA approval or clearance to sell in the U.S. and will require
approvals from comparable agencies to sell in foreign countries. These authorizations may limit the U.S.
or foreign markets in which our products may be sold. Although the majority of our products related to
freezing blood components are currently exempt from the requirement to file a 510(k) or PMA, that
situation may change in the future if the FDA moves to regulate cell therapy products. In anticipation of
possible future regulation by the FDA, the Company has filed, and is maintaining, a Master File on the
BioArchive System and the AXP Platform. However, currently the BioArchive, AXP, and the
ThermoLine products are being marketed and sold worldwide. Further, our products must be
manufactured under principles of our quality system for continued CE-Marking so they can continue to be
marketed and sold in Europe. These principles are similar to the QSR of both the FDA and California
Department of Public Health. Failure to comply with or inappropriately interpret these quality system
requirements and regulations may subject the Company to delays in production while it corrects
deficiencies found by the FDA, the State of California, or the Company’s Notifying Body as a result of
any audit of our quality system. If we are found to be out of compliance, we could receive a Warning
Letter or an untitled letter from the FDA or even be temporarily shut down in manufacturing while the
non-conformances are rectified. The FDA may also invalidate our PMA if appropriate regulations
24
26. relative to the PMA product are not met. The Notified Bodies may elect to not renew CE-Mark
certification. Any of these events would negatively impact our revenues and costs of operations.
Future Regulatory Changes May Affect Our Business. On August 3, 2010, the FDA released for public
comment two internal working group reports with numerous recommendations (1) to improve the 510(k)
process, and (2) to utilize science in regulatory decision making in ways that encourage innovation yet
maintain predictability. Comments are due in 60 days and the FDA is targeting the implementation of or
setting timelines for the implementation of “non-controversial” recommendations by the end of the year.
At the same time, the FDA acknowledges that the recommendations are preliminary and no decisions
have been made on specific changes to pursue. Nevertheless, we anticipate significant changes will result
in the way 510(k) programs will operate and the data requirements, including clinical data, to obtain
510(k) clearance or PMA approval. We cannot predict what effect these reforms will have on our ability
to obtain 510(k) clearances or PMA approvals in a timely manner or the effect on our business.
Competition in Our Industry is Intense and Will Likely Involve Companies with Greater Resources than
We Have. We hope to develop a competitive advantage in the medical applications of our products, but
there are many competitors that are substantially larger and possess greater financial resources and more
personnel than we do. Our current principal market is cord blood banks, and with regards to the
BioArchive System and AXP Platform, numerous larger and better-financed medical device
manufacturers may choose to enter this market as it develops.
Influence By the Government and Insurance Companies May Adversely Impact Sales of Our Products.
Our business may be materially affected by continuing efforts by government, third party payers such as
Medicare, Medicaid, and private health insurance plans, to reduce the costs of healthcare. For example,
in certain foreign markets the pricing and profit margins of certain healthcare products are subject to
government controls. In addition, increasing emphasis on managed care in the U.S. will continue to place
pressure on the pricing of healthcare products. As a result, continuing efforts to contain healthcare costs
may result in reduced sales or price reductions for our products. To date, we are not aware of any direct
impact on our pricing or product sales due to such efforts by governments to contain healthcare costs, and
we do not anticipate any impact in the near future.
Product Liability and Uninsured Risks May Adversely Affect the Continuing Operations. We operate in
an industry susceptible to significant product liability claims. We may be liable if any of our products
cause injury, illness, or death. These claims may be brought by individuals seeking relief or by groups
seeking to represent a class. We also may be required to recall certain of our products should they
become damaged or if they are defective. We are not aware of any material product liability claims
against us. However, product liability claims may be asserted against us in the future based on events we
are not aware of at the present time. We maintain a general liability policy that includes product liability
coverage of $1,000,000 per occurrence and $2,000,000 per year in the aggregate. However, a product
liability claim against us could have a material adverse effect on our business or future financial
condition.
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27. Risks Related to Our Common Stock
Trading Prices for our Common Stock Have Been, and May Continue To Be, Volatile. The trading price
of our common stock has been subject to wide fluctuations and may continue to be volatile in the future.
Trading price fluctuations can be caused by a variety of factors, many of which are beyond our control,
including, among other things:
· Variations in operating results,
· Regulatory actions, such as product recalls,
· Governmental regulatory acts,
· Biological or medical discoveries,
· Changes in earnings estimates by securities analysts, and
· Market conditions in our industry and the economy as a whole.
If our revenues or operating results fall below the expectations of securities analysts and investors, the
price of our common stock would likely decline. In the last few years, the stock market experienced
extreme price and volume fluctuations due to the unprecedented turmoil and upheaval of the credit
markets and the financial services industry, which have particularly affected the market prices for
emerging biotechnology and medical device companies, and has adversely affected the market price of
our common stock.
If the Price of our Common Stock Does Not Meet the Requirements of the NASDAQ Capital Market Stock
Exchange (“NASDAQ”), Our Shares may be Delisted. Our Ability to Publicly or Privately Sell Equity
Securities and the Liquidity of Our Common Stock Could be Adversely Affected if We Are Delisted. One
of the requirements for continued listing on NASDAQ requires a company’s minimum bid price to be
above $1.00 per share. On August 9, 2010, our Board of Directors declared a one for four reverse stock
split effective at the close of business on August 26, 2010 which resulted in a $2.08 per share stock price.
If our share price falls below $1.00 for 30 days, our shares may be delisted or the Company may have to
take other action to avoid delisting. Delisting from NASDAQ could adversely affect our ability to raise
additional financing through the public or private sale of equity securities, would significantly affect the
ability of investors to trade our securities and would negatively affect the value and liquidity of our
common stock. Delisting could also have other negative results, including the potential loss of
confidence by employees, the loss of institutional investor interest and fewer business development
opportunities.
We Do Not Pay Cash Dividends. We have never paid any cash dividends on our common stock and may
not pay cash dividends in the future. Instead, we intend to apply earnings to the expansion and
development of our business. Thus, the liquidity of your investment is dependent upon your ability to sell
stock at an acceptable price. The price can go down as well as up and may limit your ability to realize
any value from your investment, including the initial purchase price.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
The Company leases a facility with approximately 28,000 square feet of space located in Rancho
Cordova, California. Approximately 50% of the facility is devoted to warehouse space and
manufacturing of products, including 500 square feet for a clean room. The other 50% is comprised of
office space, a biologics lab and a Research and Development lab. Under the current amendment, the
lease expires in October 2016.
26
28. The Company leases a second facility with approximately 14,000 square feet. The two facilities are
located in the same commercial complex. Approximately 30% of the second facility is devoted to
warehouse space. The remaining 70% is comprised of office space. The lease expires in March 2012.
Under the terms of the lease, on July 22, 2010 the Company gave a “Notice to Vacate” in 180 days or
January 21, 2011.
At fiscal year end, the Company did not own or lease any other facilities.
ITEM 3. LEGAL PROCEEDINGS
The Company and its property are not a party to any pending legal proceedings. In the normal course of
operations, the Company may have disagreements or disputes with employees, vendors or customers.
These disputes are seen by the Company’s management as a normal part of business, and there are no
currently pending actions or threatened actions that management believes would have a significant
material impact on the Company’s financial position, results of operations or cash flows.
ITEM 4. [REMOVED AND RESERVED]
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29. PART II
ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY AND RELATED
STOCKHOLDER MATTERS
The Company’s common stock, $0.001 par value, is traded on NASDAQ under the symbol KOOL. At
the close of business on August 26, 2010, we effected a 1-for-4 reverse split of our common stock. The
following table sets forth the range of high and low bid prices for the Company’s common stock for the
past two fiscal years as reported by NASDAQ. All amounts in the table have been adjusted to give effect
to the reverse stock split.
Fiscal 2010 High Low Fiscal 2009 High Low
First Quarter (Sep. 30) $2.92 $2.16 First Quarter (Sep. 30) $7.36 $4.68
Second Quarter (Dec. 31) $2.80 $2.24 Second Quarter (Dec. 31) $5.12 $1.24
Third Quarter (Mar. 31) $3.08 $2.04 Third Quarter (Mar. 31) $3.36 $1.60
Fourth Quarter (June 30) $3.20 $1.84 Fourth Quarter (June 30) $3.08 $2.04
The Company has not paid cash dividends on its common stock and does not intend to pay a cash
dividend in the foreseeable future. There were approximately 271 stockholders of record on June 30,
2010 (not including street name holders).
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30. The following graph compares the performance of the Company’s common stock during the period June
30, 2005 to June 30, 2010, with the NASDAQ Stock Market Index and the Company’s peer group of
NASDAQ stocks:
COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN*
Among ThermoGenesis Corp., the NASDAQ Composite Index
and a Peer Group
$160
$140
$120
$100
$80
$60
$40
$20
$0
6/05 6/06 6/07 6/08 6/09 6/10
ThermoGenesis Corp. NASDAQ Composite Peer Group
*$100 invested on 6/30/05 in stock or index, including reinvestment of dividends.
Fiscal year ending June 30.
6/05 6/06 6/07 6/08 6/09 6/10
ThermoGenesis Corp. 100.00 94.71 63.45 32.18 14.48 11.19
NASDAQ Composite 100.00 107.08 130.99 114.02 90.79 105.54
Peer Group 100.00 120.33 146.76 149.27 105.83 134.27
29