2014 Annual Report

40 years of saving and enhancing lives 2014 Annual Report

Message from the Chairman of the Board & the CEO

A future built on a solid past If the past is the foundation of the future, BioBridge Global (BBG) is in a remarkable position. Our mission to save and enhance lives around the world over the course of 40 years has helped us evolve into a global participant in the biotech industry.

Dennis Stahl Chairman of the Board BioBridge Global

In 1974, as the South Texas Regional Blood Bank, we began collecting and testing blood from generous area donors, ensuring it reached those in need. We grew to be a medical industry partner and a pillar of the community. Later, we changed our name to the South Texas Blood & Tissue Center and spun out our subsidiaries – The Blood & Tissue Center Foundation, QualTex Laboratories and GenCure – into their own nonprofit entities. We grew from 12 employees in 1974 to nearly 725 in 2014, making us among the larger employers – nonprofit or otherwise – in the city, according to the San Antonio Economic Development Foundation.

Establishing BBG as a nonprofit umbrella organization and implementing a strategic plan to leverage our unique resources was an exhilarating move into the future, and 2014 was our first year embodying that new identity. Among our achievements, BBG entered into an unprecedented alliance with a private biomedical firm in which it leases BBG lab space to conduct stem cell research and product development. Also, a chief operating officer for QualTex Laboratories was hired.

Linda Myers CEO BioBridge Global

The focal point was BBG’s co-organizing of the World Stem Cell Summit. The event showcased our capabilities to the world, and we’re tapping the invaluable network of the summit, exploring international collaborations and partnerships. Even in this lofty forum, it was clear what BBG offers – access to biomaterials as well as procurement and testing expertise – is uncommon among our peers.

Our dedicated employees and their passion for our mission have helped elevate our organization throughout these transitions. As we’ve expanded services, our team members have adapted and helped build BBG into the organization it is today.

Through extraordinary vision over four decades, BioBridge Global has positioned itself to be a leader in blood resource management, biologic testing and regenerative medicine by refining an infrastructure that holistically supports its mission. Every facet enables research and development as we continue our longtime service to the community, bringing hope to the ill and injured in Texas and around the world.

Financials

Revenue By Source

Expenses

n Client Testing.......................... 69.1% n Blood & Tissue Processing...... 26.0% n Other Revenues........................ 4.9%

n n n n n n n

Testing. . .................................. 53.2% Wages.................................... 21.9% Purchased Services & Other.... 10.5% Supplies................................... 6.5% Benefits.................................... 4.8% Depreciation............................. 2.3% Interest Exp.............................. 0.8%

SouthTexasBlood.org

S

ince 1974, donors, patients and customers of the South Texas Blood & Tissue Center

In 2014, STBTC was honored with the enthusiastic support of our donors; a total of 145,308 potential donors walked through our doors or came to a mobile drive, ready to give of themselves and be part of our critical mission to save lives.

STBTC significantly increased its efforts to improve efficiency and quality, including:

(STBTC) have depended on us to have an adequate blood supply

▶ ▶ Increasing our telerecruiting productivity rate, resulting in an additional

available whenever and wherever

8,125 appointments for the year

it’s needed. Our deep-rooted history

▶ ▶ Registering an additional 4,868 donors at our fixed-site donor rooms

in blood banking and extensive

▶ ▶ Adding a Sunday donor room rotation, increasing platelet collections by an average of 18 additional products per weekend

base of generous donors position STBTC to serve medical and research

▶ ▶ Implementing a call-recording system to train and mentor staff

communities in Texas and beyond

▶ ▶ Implementing software that saved $100,000 through increased calling efficiency

by providing blood, plasma, platelets

▶ ▶ Reducing the average number of mobile blood drive cancellations per

and specialty products.

month from 81 to 44

▶ ▶ Achieving excellent external audit results with zero Form 483s from the Food and Drug Administration (FDA)

In addition, Donor Services completed its first Lean Six Sigma project to improve phlebotomy efficiencies. One major change was replacing the terminology “Quantity Not Sufficient” (QNS) with “First Time Right” (FTR), indicating a phlebotomy was correctly performed, resulting in a transfusable blood product. The efficiencies raised the number of successful phlebotomies on the first attempt by 50 percent, yielded more than $500,000 in savings and increased the amount of blood available for patients.

STBTC products distributed for 2014

n n n n n

The Component Lab increased its platelet pool production by 59 percent over the previous year and validated new blood separation devices.

Additionally, Hospital Services entered into three new hospital contracts and completed development and validation of its new online ordering program with plans for rollout to all the hospitals we serve beginning in early 2015.

RBCs...................................... 116,654 Fresh Frozen Plasma................. 27,452 Apheresis.. ................................ 25,966 Whole Blood RDPs.................... 12,385 Cryoprecipitate........................... 6,628

STBTC is grateful for the many community-minded individuals willing to support the organization and roll up their sleeves to help patients. In 2015, STBTC will focus on continued efficiencies and quality improvement. We also will implement the electronic donor questionnaire to simplify and dramatically improve the donation process.

STBTC Automation Products 2012-2014 35000 30000 25000 20000 15000 10000

2012 5000

2013 2014

0 Total number of products collected by automation (more products collected from fewer donors)

QualTexLabs.org

Q

ualTex Laboratories is one of the largest independent nonprofit

testing laboratories in the United States. It is focused on supporting global public safety at its Texas and Georgia locations by providing advanced biologic testing services for whole blood and plasma as well as for human cells, tissue and cellular- and tissue-based products (HCT/P). QualTex’s internationally recognized services continue to expand as its global biotechnology and biopharmaceutical customers’ needs for high-quality testing grow.

QualTex, which was officially established as its own 501(c)(3) in 2007, had a transformative year in 2014. Medical Director Dr. Norman D. Kalmin retired after 31 years, and Dirk Johnson was hired as chief operating officer, bringing 25 years of blood banking knowledge. QualTex also marked several successes:

▶ ▶ Tested a record number of samples ▶ ▶ Opened the Atlanta Immunohematology Reference Lab (IRL) ▶ ▶ Achieved new certifications in the states of New York, Rhode Island and Pennsylvania, enabling QualTex to expand testing services to these states and allowing us to remain in compliance with state regulations and requirements

▶ ▶ Selected as vendor of choice for Blood Centers of America ▶ ▶ Internal research team completed development of Hepatitis E virus

nucleic acid test (NAT) that detects HEV in human plasma, preparing QualTex to support future regulatory requirements as HEV has been identified as an emerging infectious disease in developed countries

▶ ▶ Realized an increase in source plasma customers due to those companies’ organic growth

▶▶ Completed two Lean Six Sigma projects to increase laboratory efficiencies and reduce waste that resulted in a validated savings of $275,000

▶ ▶ Received more than 20 successful audits by national and international customers, potential customers and regulatory agencies

QualTex by the numbers year over year 2013-2014 Total samples tested

11% increase over 2013

Whole blood volume

21% increase over 2013

Source plasma samples tested

12% increase over 2013 HCT/P tested

52% increase over 2013 Specialty products tested

43% increase over 2013

QualTex continued to grow its whole-blood customer base, adding six key new accounts. A substantial portion of this business is going into Atlanta.

Because the Hartsfield-Jackson Atlanta International Airport has direct flights around the world, QualTex can offer customers multiple shipping options and expedited sample delivery.

QualTex also completed a major initiative – an onboarding process for new customers to facilitate the ease with which they can begin doing business with QualTex. When a customer chooses QualTex as its service provider, the QualTex team works to evaluate its unique internal operational requirements. QualTex then provides customized testing services, which meet the customer’s needs and help to achieve its mission. The process includes feasibility studies and feedback to the customer. QualTex strives to exceed each aspect of a customer’s requirements, and the result is a smooth and productive relationship.

GenCure.org

G

enCure uses the power

In 2014, GenCure received its own 501(c)(3) nonprofit corporation designation. To further its mission and foster crossfunctional operations, GenCure shed official references to separate centers, resulting in a more cohesive branding approach designed to ensure personnel engage together across all potential opportunities.

of human cells and tissue to inspire hope,

enhance lives and enable clinical

During 2014, the construction of the GenCure Applied Regenerative Medicine Laboratory (GARML) was completed. The laboratory will be used to identify, differentiate, grow and collect stem cells and other biomaterials.

The biomaterials will then be transformed into products and services that researchers, physicians and clinicians can use to facilitate further research into the use of stem cells in regenerative medicine.

advancements in the field of regenerative medicine. Through its tissue, cord blood and cellular therapy centers, GenCure serves

GenCure further broadened its product portfolio by employing computeraided design (CAD) engineering capabilities to support manufacturing of custom-engineered tissue components in line with cGMP and quality standards. It also established its own quality assurance department to continue to meet and exceed the rigorous standards that govern its daily operations.

the global community by providing lifesaving units for transplant, components to the medical community to treat ill and injured

In addition, this year GenCure:

patients and supporting biomedical

▶ ▶ Constructed 2,700 square feet of Class 100 tissue processing

research efforts.

cleanrooms

▶ ▶ Manufactured 3,976 tissue products ▶ ▶ Sent 60 cord blood units (CBUs) for transplant, the highest in the program’s history

TCBB Cord Blood Units Banked and Collected 2013 vs 2014

▶ ▶ Sent 277 CBUs for research 300

10000

250

8000

200 6000 150 4000 100 2000

50

2013 2014 0

0

Cord Blood Units Collected

Cord Blood Units Banked

Tissue Collections 2013 vs 2014 300 250 200 150 100 50

2013 2014

0

Tissue Donors Recovered

Tissue Donors Processed

▶ ▶ Registered 17,855 new members to the national marrow donor registry ▶ ▶ Conducted collections from 56 peripheral blood stem cell (PBSC)

and bone marrow donors who were found to be matches for patients needing transplants

GenCure’s growth has greatly expanded the products and services it makes available to the medical community and its research partners in the fastgrowing field of regenerative medicine.

BloodnTissueFoundation.org

T

he mission of The Blood & Tissue Center Foundation is to advocate for increased

community awareness and to develop financial and other resources in support of BioBridge Global and its subsidiaries. Since 2002, the Foundation has raised nearly $10 million dollars for efforts such as purchasing cutting-edge equipment and educating the public about the lifesaving work of BioBridge Global.

In 2014, the Foundation experienced growth and renewal as it focused on the future and its invaluable work to help save lives. Its dedicated and compassionate community leaders graciously gave of their time, commitment and resources to raise funds and educate the community.

The board embarked on an endeavor to develop a comprehensive longterm strategic plan that will direct the Foundation’s efforts into the future.

Through the outstanding leadership of the strategic planning committee and the unwavering commitment of board members, a “defining living document” was created. It will chart the course for the Foundation as it expands to support the emerging field of regenerative medicine.

Through the dedication and generous contributions from our members, along with community support, The Ruskin C. Norman Founders’ Circle raised $53,667. The Founders’ Circle exclusively supports the efforts of the Texas Cord Blood Bank (TCBB).

The Foundation marked the 20th Annual Marrow Ambassadors Golf Tournament, which raises funds for recruiting bone marrow donors for patients needing marrow transplants. The event featured a touching meeting between a leukemia survivor and his stem cell donor.

In September, the Foundation hosted its marquee event, the Red and White Ball. The event raised $176,099 to support programs, services and equipment needs.

Throughout the year, the Foundation received numerous in-memoriam and honorary contributions and grants supporting programs that have special meaning to individual donors.

2014 Foundation funds raised

n n n n n n

Red and White Ball.. ............ $ 176,099 Other.................................. $ 101,280 Cord Blood........................... $ 71,480 Founders’ Circle.. .................. $ 53,667 Bone Marrow........................ $ 18,571 Golf Tourney......................... $ 13,467

The Foundation Board’s quarterly luncheons in 2014 featured expert guest speakers who shared their expertise in current and innovative research taking place in regenerative medicine. The luncheons helped Foundation Board members better understand their vital role in advocating for BioBridge Global programs, services and equipment needs. For example, the Founders’ Circle has helped purchase BioArchive storage systems for the cord blood center, giving GenCure the ability to store additional lifesaving units available for transplant around the world.

Total. . ............................................ $ 434,564

The reason for our work The important work of the Foundation and the purpose it serves is never more evident than in the story of AJ Salazar, who was diagnosed with leukemia in February 2000, a few weeks before his 4th birthday. His best chance for survival was a marrow or cord blood transplant.

At the time of AJ’s diagnosis, his mother was seven months pregnant with his sister Brianna. Brianna’s cord blood, collected at her birth, turned out to be a perfect match for AJ. He received her cord blood as a transplant and lived to see his fifth birthday and beyond.

Today, AJ is graduating from high school and heading to college, where he hopes to continue his lifelong dream of playing football.

AJ in 2000 holding baby sister Brianna

AJ in 2015

The decades that led to our future Over 40 years, BioBridge Global has witnessed different names, changes of location, the speed of technology and the addition of products and services that weren’t even imagined back in 1974. We proudly look back on our past in preparation for our future and the promise it holds for our now-diverse organization and everything it can contribute to the field of regenerative medicine.

1980s 1970s

2

1

4

6

Past

3

1 In 1974, the South

Texas Regional Blood Bank was established with the support of the Bexar County Medical Society.

2 From 12 in 1974 to more than 700 today, employees help anchor our organization with their commitment to quality.

5

3 Over the decades,

blood donations from dedicated volunteer donors have helped meet patient needs.

4 Employees became more highly skilled as technology continued to evolve.

5 Henry Cisneros and other community leaders across South Texas supported our lifesaving mission.

6 The mid-1980s marked a growth in services as patients of all sizes required lifesaving transfusions.

6211 Interstate 10 West San Antonio, Texas 78201

2000s 1990s 10

12 7

8

13 11

9

7 In 1994, the blood bank changed its name to the South Texas Blood & Tissue Center (STBTC) and settled into North Central San Antonio to accommodate expanded services. The building is now BioBridge Global BioBridge Global (BBG) headquarters.

6211 Interstate 10 West San Antonio, Texas 78201

BioBridgeGlobal.org

Future

8 Tissue services began in 1994, bringing lifeenhancing therapy to hundreds of patients every year.

10 QualTex Laboratories

12 In 2013, BBG became

9 In 1998, cord blood collections began bringing hope to patients in need of a stem cell transplant.

11 The Donor Pavilion

13 In 2014, GenCure

SouthTexasBlood.org

became a separate 501(c) (3) in 2007 and opened a facility in Atlanta in 2011.

opened in 2008 to better serve our blood donors.

QualTexLabs.org

GenCure.org

the parent organization of STBTC, QualTex, GenCure and The Blood & Tissue Center Foundation. became a separate 501(c) (3), helping patients such as Valentina DeLeon, a cord blood recipient.

BloodnTissueFoundation.org