2016 corporate profile

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2016 Corporate Profile www.BioDermInc.com compassionate solutions

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Page 1: 2016 Corporate Profile

2016 Corporate Profilewww.BioDermInc.com

compassionate solutions

Page 2: 2016 Corporate Profile

Improving quality of life, everyday, with innovative

healthcare products.

BioDerm, Inc.

Page 3: 2016 Corporate Profile

compassionate solutions

Who We AreHeadquartered in Largo, Florida, BioDerm is a global leader in proprietary hydrocolloid products for urinary management, infection control and skin protection. The company challenges accepted inferior standards of care by creating products that reduce infection rates, add comfort and reliability, and vastly improve quality of life.

Company Evolution

1991: BioDerm, Inc. is founded as a research and development organization.

1997: FDA rules the External Continence Device (ECD) as 510(k) exempt.

2000: Began initial testing of proposed direct-to-consumer sales models.

2006: BioDerm begins testing sales of a redesigned and improved Liberty catheter with integral collection chamber; Medicare Part B reimbursement is granted under HCPCS Code A4326; First international sales begin to the UK and the Netherlands.

2011: Launched full scale, national direct-to-consumer sales campaign; Gary Damkoehler, formerly CEO of JSA Healthcare Corp, takes over as CEO; BioDerm receives code verification from the Center for Medicare and Medicaid Services to support billing under HCPCS Code A4326.

2012: BioDerm rebrands as Men’s Liberty in the consumer market and Safe n’ Dry in the acute care market; Introduces new adjunct product lines: BioPlus+, FreeDerm and CathGrip.

2013: BioDerm brings on an independent sales team and national sales manager to drive growth; BioDerm awarded a U.S. Federal GSA Schedule contract under Schedule 65 II A—Medical Equipment and Supplies.

2014: BioDerm awarded Catheter Securement supplier agreement with the Premier Healthcare Alliance; Launch of BioDerm Penile Clamp; Acute Care sales partnerships established with independent rep groups. Attended Medica tradeshow to increase international sales.

2015: Launch of new products to the CathGrip securement line, PEGprotect and WingSeal. Established new international distribution agreements in Canada and the Middle East. Built on-site clinical support team for patients, sales reps and healthcare professionals.

2016: BioDerm brings in new President, Gaet Tyranski, to accelerate growth in 2016 and beyond.

Page 4: 2016 Corporate Profile

What We Do BioDerm® specializes in the manufacture of urology, skin interface, and catheter securement products. All BioDerm’s products are made from the company’s proprietary hydrocolloid formulation that is hypoallergenic, latex free, and moves like a second skin. All BioDerm products aim to provide a superior patient experience through added comfort, reliability and safety.

Men’s Liberty™ is a proprietary, innovative alternative to traditional male external catheters. It is completely external and applied just once a day. This discreet, one-size-fits-all option manages men’s urinary incontinence in a safe, healthy way. More than 3 million units have been used with zero attributable adverse events, including urinary tract infections.

Safe n’ Dry™ is a proprietary male external catheter designed for institutional and hospital use. It is completely external and seals gently and securely to the tip of the penis with BioDerm’s proprietary hydrocolloid adhesive XtraDerm™. Safe n’ Dry is currently private labelled for Eloquest Healthcare® as ReliaFit®.

CathGrip® is a proprietary universal catheter securement system. With soft no-slip grips that secure tubes from 2-47Fr and three sizing options for the hydrocolloid base, CathGrip can meet all your securement needs in only 13 SKUs, making it the new standard of care sought after by physicians, nurses and purchasing teams. CathGrip now includes speciality securement for PEG/PEJ and epidural tubes.

Our proprietary adhesive remover, FreeDerm™ is the only adhesive remover on the market to instantly release hydrocolloid and other adhesives by breaking the bond between the adhesive and the skin. With a no-sting, flash dry formula, FreeDerm ensures painless removal of any hydrocolloid products even on compromised skin.

Page 5: 2016 Corporate Profile

Our Sales Approach

OUTPATIENT

BioDerm’s products are sold through its world-class customer service center, based in Largo, Florida. Customer service reps are trained to understand the conditions associated with urinary incontinence, and are extremely knowledgeable about all BioDerm’s products. BioDerm also provides on site clinical support and a robust quality auditing program to ensure the highest quality service and support.

ACUTE CARE

BioDerm’s CathGrip product line is sold through a growing network of direct and independent representatives targeting acute care, long term care and other surgical centers. Our representatives currently cover more than 80% of states in the US, introducing CathGrip into ICUs, Interventional Radiology, Wound Care and more.

INTERNATIONAL

BioDerm’s products are currently available for sale in the United Kingdom, Canada, the Netherlands, South Korea, Poland and the United Arab Emirates through a network of independent distribution partners in each country.

PARTNERSHIPSBioDerm’s urinary management products for acute care are currently private labelled and sold by Eloquest Healthcare as ReliaFit and the ReliaFit Kit with CathGrip. Other BioDerm products are available for private label collaboration for the target markets and partnerships.

Executive Management

Gary Damkoehler, Chairman and CEO

Gaet Tyranski, President

John DeBella, Chief Operating Officer

Wendy LaTorre, Chief Strategy Officer

Byron Dyke, Chief Financial Officer

James Terpstra, National Sales Manager

Joe Carrens, VP of Quality and Regulatory Affairs

Steve Babb, VP of Product Technology

Media Contact: Sarah Woodward, (727) 507-7655 ext. 2019 or [email protected]

You can find more info here: www.BioDermInc.com

Page 6: 2016 Corporate Profile

REFERENCES: 1. Catheter Stabilization Device/Catheter Securement Devices Market by Product, Application, End User – Global Forecast to 2020, Research and Markets, June 2015, Available online: http://www.researchandmarkets.com/reports/3287155/catheter-stabilization-devicecatheter-securement. 2. Global Male External Catheters Market 2015-2019, TechNavio Insights, Published April 2015. Available online: http://www.researchandmarkets.com/reports/3150284/global-male-external-catheters-market-2015-2019#pos-0

Drivers of Business GrowthBased on several independent research publications and market studies, BioDerm expects to continue delivering strong revenue and profit growth in the decades to come.

Key growth estimates include:

• The global catheter stabilization device market is expected to reach $1,372.35 Million by 2020 from $957.26 Million in 2015, growing at a CAGR of 7.47% between 2015 and 2020.1

• The Global Male External Catheters market was valued at US$152.11 million in 2014 and is expected to reach US$200.13 million by 2019, growing at a CAGR of 5.64 percent.2 However, BioDerm has been increasing its sales at over 47% annually since 2011.

• The major drivers for both of these markets include: increasing healthcare expenditure, growing aging population, increasing prevalence of lifestyle diseases, and increasing demand for minimally invasive surgeries/treatment options.1, 2

Key internal growth drivers include:

• BioDerm was awarded a contract as a national provider of securement devices for drainage and catheters by the Premier Healthcare Alliance, opening up nearly 3,000 acute care facilities for BioDerm sales.

• Grown direct to consumer advertising programs by more than 50% since 2013. BioDerm continues to acquire a record number of new customers each month at a highly competitive cost per acquisition.

• Launched aggressive international distribution partnerships, projected increase of international revenue by 100% in 2015.

• Established sales coverage for the acute care channel covering more than 80% of states in the US.

Page 7: 2016 Corporate Profile

“BioDerm continues to grow by exceeding our clients’ expectations at every turn. We’re committed

to delivering the best products that make a real difference in our customers’ daily lives.”

~Gary Damkoehler, CEO, BioDerm, Inc.

Page 8: 2016 Corporate Profile

AccomplishmentsSuccess is a collaborative effort. BioDerm’s executive team has reduced manufacturing costs by over 60%, increased sales revenue by over 47% each year since 2011, increased staff to support growth, expanded manufacturing, and updated its technology to improve efficiency and facilitate growth.

In addition, we have:

• Helped thousands of clients regain their dignity and quality of life with the Men’s Liberty device. More than three and half million units sold with zero attributable adverse events reported

• Reduced carbon footprint by replacing the majority of our products’ plastic packaging with recycled and biodegradable materials

• Expanded call center operations to handle increased customer volumes; updated technology and introduced a Noble Dialer system

• Installed an updated, secure CRM solution to manage client files safely and ensure that minimum HIPAA guidelines for data security are exceeded

• Grown direct-to-consumer advertising programs, generating a record number of new customers each month at a highly competitive cost per acquisition

• Successfully launched and maintained a content marketing program that has established BioDerm as an industry thought leader; pioneered direct-to-consumer blogging and social media campaigns on incontinence that have cultivated a growing following

• Established new partnerships with major U.S. and international distribution partners to expand product penetration into the acute care market

• Worked with Enterprise Florida, the Small Business Development Center and the Chamber of Commerce to grow our international sales program and raise awareness of our brands

• Developed tradeshow calendar for domestic and international sales including the Medica show in Dusseldorf, Germany.

• Secured 15 patents and patents pending for entire product suite• Launched a new catheter securement product line to expand reach into the acute care and hospital market• Launched and expanded on-site clinical support team in our Largo offices including support for clinical trials,

evaluations and value analysis. Support ongoing development of acute care marketing collateral including videos, white papers, brochures and other materials as needed

• Introduced manufacturing automation in 2014 to reduce costs • Successfully completed ISO-13485 certification for manufacturing and exporting to international markets• Launched a new penile clamp product in 2014 for the out-patient market• Registered with the Better Business Bureau and secured an A+ rating

Page 9: 2016 Corporate Profile

John DeBellaChief Operating Officer

DeBella has more than 30 years of experience in manufacturing operations, including Manufacturing Management for Square D Corporation. He received his Bachelor’s degree in Industrial Technology from the University of Dayton, and his Masters in Business Administration from the Florida Institute of Technology. DeBella is also an adjunct professor teaching courses on Six Sigma Techniques, Quality and Statistical

Processes at St. Petersburg College.

Wendy LaTorreChief Strategy Officer

LaTorre is a marketing and sales executive with more than 20 years of experience, including 16 years in the direct response industry. Since joining BioDerm in 2012, she has developed and led branding and marketing efforts that have boosted company and product awareness and supported sales revenue growth by more than 47% each year. LaTorre was previously director of marketing for a $30 million direct response company. LaTorre holds a Bachelors degree in Marketing

from Eckerd College.

Jim TerpstraNational Sales Manager

Prior to joining BioDerm, Jim was Director of Corporate Accounts for Eloquest Healthcare where he was responsible for negotiating contracts with GPOs, distributors and integrated health networks for product distribution, building and supporting a growing sales team and generating real term revenue growth to meet and exceed corporate goals. Before Eloquest, Jim spent 9 years with Sage Products, where he held leadership positions in corporate account development and was regularly

recognized as Sales Person of the Year.

Byron DykeChief Financial Officer

Dyke has 25 years of experience in corporate financial leadership in public and private enterprises encompassing start-up, developing and rapid-growth environments. His expertise spans managed growth, strategic planning, fiscal troubleshooting, mergers and acquisitions, process re-engineering. He has also overseen information technology implementations. Mr. Dyke holds a Bachelor of Science degree in Business Administration/Accounting

from Ohio State University.

Steve BabbVP of Product Technology

Babb is a leader with 30-plus years of experience in medical device, chemical processing, aerospace, nuclear, information technology and business consulting industries, Babb excels at creating chains of value and quality extending from suppliers through customers. Since joining BioDerm in 2007, he has created and patented several new consumable medical products, and released them to market. Babb earned his Bachelor of Science degree in Chemical Engineering from Georgia Institute of Technology, and his Masters in Chemical

Engineering from the Univ. of Florida.

Joe CarrensVP of Quality & Regulatory

AffairsCarrens is an FDA compliance inspection veteran with more than 35 years of experience in medical device product/process development. His expertise encompasses production, testing, validation, quality assurance (QA), regulatory affairs and FDA product submissions. Carrens oversees BioDerm’s development and implementation of all processes for new and existing product lines, including market feedback.

LeadershipGary Damkoehler, Chief Executive OfficerDamkoehler is a veteran healthcare industry executive and former Chairman of the Board of JSA Healthcare Corporation. After successful stints at USAID and Westinghouse’s Health Systems Division, he joined the predecessor company to JSA in 1984. Damkoehler founded JSA’s Government Services Division, which grew from $120,000 in sales in 1984 to $21.4 million in 1989, an achievement that placed the company on the Inc. 500 List. He was appointed President of JSA in 1985 and Chairman of the Board in 1988. Damkoehler holds a Bachelor’s degree in Economics from the University of Alabama and a Masters degree in Economics from the University of Alabama.

Gaet Tyranski, PresidentTyranski is a global P&L Executive with a proven track record of organic and inorganic growth, continuous improvement, customer satisfaction and employee development. He is a veteran of multiple rapid-growth organizations, including start-ups and multi-million-dollar healthcare manufacturers and service providers. Prior to joining BioDerm, Tyranski was with Jabil Circuit in progressive roles for 14 years, before moving to Synergy Health, a global sterilization services company, in 2014 where he was President, Applied Sterilization Technologies – Americas. Gaet has a BA in economics and political science from Bucknell University and a MBA from the University of Florida. He is a Board Member of the Florida Medical Manufacturers Consortium (FMMC).

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Making a Difference in Our CommunityBioDerm is proud of our ongoing partnership with all of our clients to deliver the best quality products and services. It truly is a collaborative effort that all our employees find rewarding. Just listen to the comments from a few of our clients over the years to understand the impact of making innovative medical products available to the people who need them.

“After many complications with prostate surgery, I was left with complete incontinence. Every

day was miserable and I did not want to go anywhere. After my doctor offered the Liberty

external catheter, life has been much better. I can now drink what I want and lead a more

normal life. I am very thankful there was a product like the

Men’s Liberty that has given me some normalcy in my life and

allowed me to be active again.”

~ Phil C.

“First, thank you for your product. In this age of product

hype and overpromises it is truly refreshing to find a manufactured

good that does everything as promised. My since of security is returning and I am now able to conduct my affairs outside our

home with confidence that I will not be embarrassed by leakage or smell. Again, you have my

gratitude.”

~Cliff C.

“I love your products. My skin was happy for one of the first times in 5 years. They don’t cause itching, or pain. After

you remove them you cannot tell where they were. They are

sturdy and they didn’t fall off (or even lift) and the clasps didn’t

break no matter how many times you opened and shut them. The BioPlus+ didn’t cause any itching

either. You have an awesome product and it truly does what it

claims to do”!”

~ Kelly I., CathGrip User

“This product has made a large impact on our lives. The most degrading thing that my husband can think of is being in a diaper. Your product helped him to avoid that bit of humiliation. We were able to utilize this product so that he could attend our daughters’ graduation in comfort and without the fear of an “accident” that would further embarrass him.” ~ Tina P.

Page 12: 2016 Corporate Profile

BioDerm, Inc.

12320 73rd Court NLargo, FL 33773

(727) [email protected]