Cerus Corporation Q3 2019 and Final FDA Guidance Update Conference - - PowerPoint PPT Presentation

Cerus Corporation

Q3 2019 and Final FDA Guidance Update Conference Call and Webcast

October 30, 2019

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Forward Looking Statements

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The following presentation includes forward-looking statements relating to Cerus’ business and clinical and commercial prospects and

• pportunities, including Cerus’ 2019 annual product revenue guidance and Cerus’ future growth prospects and expectations, Cerus’

expectations regarding gross margins, Cerus’ planned commercialization efforts and expectations, potential market opportunities for the INTERCEPT Blood System and its potential commercial, logistical, safety, economic and regulatory compliance advantages, potential regulatory interactions, submissions, approval decisions and projected timelines related thereto, potential efficacy of the INTERCEPT Blood System and Cerus’ plans to pursue further development thereof, anticipated future milestones and projected timelines, including those related to the INTERCEPT cryoprecipitate opportunity and other regulatory and commercialization milestones, and Cerus’ expectations, beliefs and plans, which involve significant risks and uncertainties. There are important factors that could cause actual events and performance to differ materially from Cerus’ forward-looking statements, including without limitation risks and uncertainties related to commercial adoption and market acceptance of the INTERCEPT Blood System, Cerus’ ability to effectively commercialize the INTERCEPT Blood System in the U.S. and abroad, including the risk that it may not meet its 2019 revenue guidance, reimbursement availability and competition, Cerus’ ability to maintain an efficient, effective and sufficient manufacturing supply chain, the uncertain nature of funding from the U.S. government and actions of Congress and governmental agencies that could adversely affect Cerus’ BARDA contract or funding therefrom, Cerus’ reliance on third parties for sales, marketing and regulatory support, product safety issues, including the risk that septic platelet transfusions may not be avoidable with the INTERCEPT Blood System, Cerus’ ability to obtain and maintain domestic and foreign regulatory approvals, including its ability to ability to expand the label claims and product configurations for INTERCEPT platelets and plasma, whether for INTERCEPT-treated extended storage cryoprecipitate or otherwise, the conduct of clinical trials and other development activities, including the risk that current or planned clinical trials of the INTERCEPT Blood System may not be initiated or completed on the anticipated timing, if at all, regulatory oversight of Cerus and its customers by the U.S. Food and Drug Administration and foreign regulatory authorities as well as compliance with other U.S. and foreign healthcare regulatory requirements, protection of intellectual property rights and Cerus’ ability to conduct its business without infringing the intellectual property rights of others, rate of consumption of and sufficiency of Cerus’ current cash reserves, Cerus’ need for additional capital, and other risks and uncertainties disclosed from time to time in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on October 30, 2019. All forward-looking statements speak only as of the time when made; Cerus undertakes no obligation to update any such forward-looking statements to reflect any future events or developments.

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William ‘Obi’ Greenman

President and Chief Executive Officer

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• Dr. Laurence Corash

Chief Scientific Officer

* European Union, Switzerland and Iceland References Represents EU, Switzerland and Iceland December 2017 market size data provided by national, regional and individual blood centers. Data on file

MKT-EN 00363-01 v4.0

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Pathogen Reduction LVDS ≥ 36h2 LVDS ≥ 48h2-4 Primary Culture2

Day 2 3 4 5 6 7 1

Available for transfusion PR process Available for transfusion

Hold ≥12h

Available for transfusion

Hold ≥12h Sample + Incubate

OR

Step 1 Step 2

Available for transfusion Available for transfusion

AND

Single Step Strategies Two Step Strategies

FDA Guidance on Bacterial Safety 9/30/191

LVDS2

Sample ≥36h

2° Culture ≥ Day 35 2° Culture ≥ Day 42,4 2° Rapid Testing4

Hold 12h Hold 12h

OR OR

Sample ≥24h Sample ≥36h Sample ≥48h Sample + Incubate

Test ≤ 24 hours prior to transfusion

• 1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry. US FDA; Sept 2019. 2. Aerobic and Anaerobic, 3. At the time of the

finalization of this guidance, the instructions for use of the culture-based device currently labeled as a “safety measure” require a primary culture and secondary test to extend dating of platelets. Therefore, the LVDS no sooner than 48 hours strategy for a 7- day dating period cannot be implemented until appropriately labeled devices are available. 4. Platelets may only be stored beyond day 5 and up to day 7 if each component is tested using a bacterial detection device cleared by FDA and labeled for use as a “safety measure” according to its instructions for use, and if the platelet storage container has been cleared or approved for 7-day storage. 5. Aerobic.

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Available for transfusion Available for transfusion

Guidance Document Definitions

• Collection Time: is the time when an apheresis platelet collection is initiated.

The day of collection is defined as Day 0, beginning at midnight, and ending at 11:59 PM.

• Expiry: occurs at11:59 PM of either day 3, 5, or day 7, depending on the option

selected.

• Hold Time: is the period during which platelets must in quarantine, prior to

sampling for bacterial culture screening and release.

• Available Transfusion Time: is the time after release from pathogen reduction
• r testing that the platelets can be transfused.
• Sample Volume: is the amount of sample which must be taken from each

platelet unit for bacterial testing.

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Number of bacteria culture bottles and sample volumes required pre and post FDA Guidance 2019 1

Post-Guidance

Single Double Triple Transfusion Bag

Pre-Guidance

Donation Bag

• 1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry. US FDA; Sept 2019.

aerobic and anaerobic culture bottles =

16 mL 32 mL 48 mL 8 mL

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• Cultures must be monitored until platelet unit expiration (day 5 or 7)
• Any positive culture bottle requires recall, and notification for

all associated platelet units

FDA Guidance on Bacterial Safety 9/30/19 (One Step Strategies)1

Day

2 3 4 5 6 7 1

• 1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry. US FDA; Sept 2019.
• 2. NAT result release times not included – will vary per facility. Assumes platelet collections on Day 0 (~8 am – 5 pm), illumination on Day 0, overnight CAD, release Day 1 as soon as test results allow.
• 3. At the time of the finalization of this guidance, the instructions for use of the culture-based device currently labeled as a “safety measure” require a primary culture and

secondary test to extend dating of platelets. Therefore, the LVDS no sooner than 48 hours strategy for a 7-day dating period cannot be implemented until appropriately labeled devices are available. 4. Platelets may only be stored beyond day 5 and up to day 7 if each component is tested using a bacterial detection device cleared by FDA and labeled for use as a “safety measure” according to its instructions for use, and if the platelet storage container has been cleared or approved for 7-day storage.

Available for transfusion Available for transfusion

PR process2 Sample ≥36h

Hold ≥12h

Available for transfusion

Sample ≥48h

Hold ≥12h

16mL total per final product aerobic + anaerobic 16mL total per final product aerobic + anaerobic

PATHOGEN REDUCTION (PR) LARGE VOLUME, DELAYED SAMPLING (LVDS) AT ≥36HR LARGE VOLUME, DELAYED SAMPLING (LVDS) AT ≥ 48HR3,4

1 2 3

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Age Distribution of Transfused Platelet Components – INTERCEPT Platelets versus Conventional Platelets

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Key Metrics for Comparison of Single Step Strategies

Single Step Strategy Hours of Hold Time Days of Culture Follow Up Delay Hours to Transfusion Available Transfusion Time (days) INTERCEPT ≤ 24 12 - 24 5.0 to 5.5 LVDS – 36 hours ≥ 36 5 48 3.5 LVDS – 48 hours ≥ 48 7 60 5.5* * Culture test allowing for 7-day shelf life is not currently FDA approved

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Vivek Jayaraman

Chief Commercial Officer

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Kevin D. Green

Chief Financial Officer

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William ‘Obi’ Greenman

President and Chief Executive Officer

Question & Answers

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Cerus Corporation

Investor Relations IR@cerus.com (925) 288-6137

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