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© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL London Healthcare Conference November 20-21, 2019
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London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

Aug 01, 2020

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Page 1: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

London Healthcare Conference November 20-21, 2019

Page 2: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Safe Harbor - Forward Looking Statements

Statements in this presentation which are not purely historical, including statements regarding the Company’s intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, such as: the Company’s expectations regarding the completion of the public offering, its expectations with respect to granting the underwriters a 30-day option to purchase additional shares and the anticipated use of net proceeds from the offering, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. It is important to note that the Company’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic conditions, trends in the products markets, variations in the Company’s cash flow, market acceptance risks, and technical development risks. The Company’s business could be affected by a number of other factors, including the risk factors discussed in the preliminary prospectus supplement relating to the offering and the documents incorporated by reference therein, which include the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed with the SEC. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this presentation. The Company disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this presentation.

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Page 3: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Cryoport – A Trusted Partner to Life Sciences Companies

Life sciences company focused on providing mission critical, proprietary temperature-controlled solutions

Unique capabilities include core competencies to ship, store and deliver biologics in a cryogenic or temperature- controlled state such as:

CAR-T and allogeneic therapies

Human and animal reproductive materials

Animal vaccines

Stem cells

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Page 4: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Quarterly Revenue Trends

$5.3M

$3.0M

$4.0M

$4.6M

Q3-2019 over Q3-2018 growth: 81%

and continued sequential growth

$3.3M

Continued quarterly revenue growth fueled by revenue expansion from existing clients and new clients Commercial

Biopharma revenue increased to $2.6M

Bioservices acquisition contributed $1.2M in revenue for Q3-2019

$5.7M

$2.9M$2.7M

$6.7M

$8.5M

Commercialized Therapies Global Bioservices

$9.6M

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Page 5: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Adjusted EBITDA

$(820,977)

$(428,922) $(435,328)$(334,774)

$250,226

$1,176,715

JUN-18 SEP -18 DEC-18 M AR -19 JUN-19 SEP -19

Page 6: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Snapshot of the Regenerative Medicine Market

ClinicalTrials

Underway Worldwide by End of Q3 20191,052 Clinical Trials

Ph. I: 363 • Ph. II: 594 • Ph. III: 95

Number of Clinical Trials Utilizing Specific

RM/AT Technology: Q3 2019

TISSUE ENGINEERING

CELL THERAPY

Total: 218Ph. I: 41Ph. II: 147Ph. III: 30

Total: 46Ph. I: 6Ph. II: 23Ph. III: 17

Total: 418Ph. I: 201Ph. II: 201Ph. III: 16

GENE THERAPYGENE-MODIFIED CELL THERAPY

Total: 370Ph. I: 115Ph. II: 223Ph. III: 32

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Page 7: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Revenue Trends & Clinical Trial Growth

Biopharma growth driven by commercial revenue. Clinical trial pipeline continues to grow.

Page 8: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Cryoport Systems’ Differentiators

Scientifically

Engineered Shippers

Near Real-time

Monitoring

& Automated

Escalation

Alerts

Biostorage

Continuous

RequalificationComprehensive

Logistics

Consulting

Rigorous Process

Intelligent Informatics

Fully Integrated System, Processes and Equipment Supported by the Life Sciences

Industry’s Most Advanced Informatics Platform and 24/7/365

Personnel

All Systems, Processes, and

Platforms Integrate to Support Chain of

Compliance™ Requirements

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Page 9: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Engineered and validated for safe transport of fragile biologics in dynamic shipping conditions

Non-hazardous liquid nitrogen dry vapor technology eliminates cellular degradation

Cryogenically stable temperature providing 10-day dynamic holding time and enabling global reach

Over a decade of data recorded regarding our Cryoport Express® Shippers

International Air Transport Association (IATA) / International Safe Transit Association (ISTA) certified

The C3™ shipper seamlessly integrates Cryoport’s expertise in packaging, informatics and logistics for the secure transport of life science commodities requiring 2-8°C temperatures

Cryoport Express® Shippers are Validated for Safe,Effective and Efficient Transport

Cryoport Express® Shippers are designed to be non-hazardous and capable of

maintaining temperatures of under -150°C for 10 days under dynamic conditions.

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Page 10: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Cryoport Advanced Therapies Shippers™

Cryoport anticipates enhanced regulatory requirements including full traceability of equipment and

processes for improper cold chain management impacting the integrity of cell and gene therapies.

Commercial and Clinical partners requested traceability for commodity history, historical use,

performance, handling, cleaning and disinfection of equipment.

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Page 11: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Page 12: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Minimizing Risk and Maximizing Success

CHAIN OF COMPLIANCETM

Traceability of the Equipment and Processes

Supporting each Client’s or Patient’s Therapy

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Page 13: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

The Cryoportal® Logistics Management Platform

Secure; 21 CFR, Part 11

Compliant

Chain-of-Custody and Chain-of-

Condition; cloud-based archival

Unit level performance tracking

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Reporting

Near real-time monitoring

Proactive alerts and escalation

Appropriate lane optimization

Corrections; Redirections;

Interceptions; Recharging alerts

Cryoportal® can integrate with

manufacturers, hub services,

partner systems, etc.

Automated scheduling

Risk Management Intervention Capable

Page 14: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

The Cryoportal® & SmartPak IITM Interface

In near real-time, Cryoport and customers can monitor and track every shipment and key statistics,

including Chain of Compliance™, through our integrated SmartPak II™ and Cryoportal® systems.

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Page 15: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Client Base of Leading Companies

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Page 16: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Clinical Trials Drive Growth in Biopharma

425

180 19154

54 Phase III clinical trials supported by Cryoport, 3 commercial launches

Commercial Launches:KYMRIAH® by NovartisYESCARTA® by Gilread/KiteZYNTEGLO™ by bluebird bio

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Page 17: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Designed to Provide Solutions for the Growing Cellular Therapy Market

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Page 18: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Yescarta® And Kymriah® Global Ramp Continues

$79 million Q3 2019 vs. $82 million FY2018 commercial revenue for Kymriah®

$118 million in net commercial Yescarta® revenue Q3 2019 vs $75 million for Q3 2018

Both therapies have successfully treated patients in Germany, U.K., France, Italy and Spain

Supporting entire cell therapy clinical trial portfolios for Novartis and Gilead

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Page 19: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

bluebird bio – ZyntegloTM

Received EU approval June 3rd , 2019 and carried PRIME designation

EMA approved refined commercial drug manufacturing specifications in October

Launching in Germany first, followed by UK and Italy

Announced plan for a rolling BLA filing in the U.S. for ZyntegloTM by end of 2019

Indicated for Patients 12 years and older with certain forms of Transfusion-Dependent BetaThalassemia (TDT)

One-time autologous gene therapy that adds functional copies of a modified form of the BetaGlobin gene into a patient’s own hematopoietic (blood) stem cells (HSC’s)

Supporting 13 ongoing clinical trials

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Page 20: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Global Partnership with Lonza

Founded 1897

Over 15,500 employees

CHF $5.5 billion of revenue in 2018

Supporting over 150 cell and gene companies

More than 100 sites and offices

Largest cellular manufacturing facility in the world located outside of Houston, TX

Common clients include bluebird bio, Adaptimmune, Mesoblast, and Cellectis

Manufacture autologous and allogeneic therapies as well as viral vectors

Complicated manufacturing and distribution processes require system integration

All stakeholders require visibility during process

Require ability to scale for commercialization

Must have repeatable processes for product quality

Process efficiency needed to help control costs

Accelerated timelines challenging industry

Evolving regulatory landscape must be considered

Client needs drive partnership

Page 21: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Cryoport & Lonza (Cell & Gene Mfg) Site Map

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Page 22: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Cryoport Expands into Biostorage

Accretive acquisition

$1,200,000 revenue for Q3 2019

Approx. 340 mechanical freezers (-80c & -20c)

Approx. 140 LN2 freezers (-196c)

Key clients include MD Anderson Cancer Center, Methodist Hospital, Texas Children's Hospital, Mesoblast, Bellicum, Merck, Baylor University, etc.

Long term contracts with recurring and growing revenues

Strategically located in Houston, TX

Proprietary CryoTrax biosample management and process control software

Clients include:

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Page 23: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Q3-2019 Financial Snapshot

Statements of Operations Data:

(in thousands) Q3-2019 Q3-2018 growth %

Net Revenues 9,583$ 5,285$ 81%

Global Logistics Solutions

Biopharma 7,460 4,472$ 67%

Animal Health 219 230 -5%

Reproductive Medicine 735 584 26%

Global Bioservices 1,169 -

Cost of revenues 4,956 2,549

Gross profit 4,627 2,736 69.1%

Loss from operations (12,352) (2,161)

Adjusted EBITDA 1,177 (429)

Net loss (12,469)$ (2,144)$

Net loss per share - basic and diluted (0.35)$ (0.07)$

Balance sheet data:

(in thousands) 30-Sep-19

Cash and s-t investments 93,502$

Working capital 96,626

Total assets 135,021

Long term obligations, less current portion 19,020

Total stockholders' equity 110,329

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Page 24: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Financial Highlights: Q3-2019

$93.5M Cash/

Short-term

Investments

Cryogene business

contributes $1.2M in

revenue for the quarter

Gross Margin

48.3%(52.3% excluding acc.

stock-based comp.

expense

Revenue

$8.5M

up 81%

Strong

embedded

growth with

existing clients

$2.6 million revenue from

commercial biopharma

clients (+368%)

Adjusted EBITDA

positive $1.2M

from ($0.4M) in Q3-2018

Supporting 425

clinical trials • US 360

• EMEA 55

• APAC 10

Biopharma

revenue

up 67%

35.7M shares o/s

Adjusted EPS

($0.35)(($0.05) excluding acc. stock-

based comp. expense)

Reproductive

Medicine

up 26%

54 Phase III

trials

All comparisons are on a Q3-2019 over Q3-2018 basis

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Page 25: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Summary

Large & rapidly developing market for temperature-

controlled logistics for the life sciences industry

Market leader with long-term client agreements

Strategically positioned with diversified client base

Leading, proprietary solutions: Cryoportal® Logistics

Management Platform and SmartPak II™ Condition

Monitoring System technology

Highly advanced and validated Cryoport Express®

shippers

Cryogene acquisition is the first step in a strategy to

augment our market leading position

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Page 26: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Appendix

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Page 27: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Capitalization Table

Type: Authorized Shares

Preferred Stock: 2,500,000

Preferred Class A 800,000 -

Preferred Class B 585,000 -

Common Stock 100,000,000 35,843,532

Warrants 1,134,883

Stock Options 6,768,434

Fully diluted 43,746,849

2018 Plan (reserved) 2,753,790

Warrant Detail

1,011,460 3.57$ 07/2020

123,423 6.00$ 03/2020 to 05/2020

1,134,883

Page 28: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Management

Jerrell Shelton, Chief Executive Officer

Robert Stefanovich, Chief Financial Officer

Mark W. Sawicki, Ph.D., Chief Commercial Officer

Bret Bollinger, Chief Technology Officer

Phil Wilson, Senior Vice President - Global Operations & Supply Chain

Joseph Rotino, Vice President of Quality Assurance & Regulatory Affairs

Rob Jones, Vice President of Global Bioservices

Thomas Heinzen, Vice President - Corporate Development & Investor Relations

Board of Directors

Jerrell Shelton, Chairman of the Board

Richard Berman, Lead Director

Daniel M. Hancock

Robert Hariri, PhD, MD

Ramkumar Mandalam, Ph.D.

Edward Zecchini

Management & Board of Directors

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Page 29: London Healthcare Conference November 20-21, 2019 · processes for improper cold chain management impacting the integrity of cell and gene therapies. Commercial and Clinical partners

© 2019 Cryoport, Inc. All Rights Reserved | CONFIDENTIAL

Science. Logistics. Certainty.

NASDAQ: CYRX

Thank you!

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