Cerus Corporation Q3 2019 and Final FDA Guidance Update Conference Call and Webcast October 30, 2019 Not to be Reproduced
Forward Looking Statements The following presentation includes forward-looking statements relating to Cerus’ business and clinical and commercial prospects and opportunities, 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. 2 Not to be Reproduced
William ‘Obi’ Greenman President and Chief Executive Officer 3 Not to be Reproduced
Dr. Laurence Corash Chief Scientific Officer 4 Not to be Reproduced
MKT-EN 00363-01 v4.0 * European Union, Switzerland and Iceland Not to be Reproduced References 5 Represents EU, Switzerland and Iceland December 2017 market size data provided by national, regional and individual blood centers. Data on file
FDA Guidance on Bacterial Safety 9/30/19 1 Day 0 1 2 3 4 5 6 7 Single Step Pathogen Reduction PR process Available for transfusion Strategies Hold LVDS ≥ 36h 2 Available for transfusion Sample ≥36h ≥1 2h Hold LVDS ≥ 48h 2- 4 Available for transfusion Sample ≥48h ≥ 12h Sample Hold Primary Culture 2 Available for transfusion ≥24h 12h Step 1 OR Hold Two Step Strategies LVDS 2 Available for transfusion Sample ≥36h 12h AND Sample + 2° Culture ≥ Day 3 5 Available for transfusion Incubate OR Step 2 Sample + 2° Culture ≥ Day 4 2,4 Available for transfusion Incubate OR Test ≤ 24 hours prior to transfusion 2° Rapid Testing 4 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” requ ire 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. 6 Not to be Reproduced
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 or 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. 7 Not to be Reproduced
Number of bacteria culture bottles and sample volumes required pre and post FDA Guidance 2019 1 Pre-Guidance Post-Guidance Donation Single 8 mL 16 mL Bag Transfusion Double 32 mL Bag Triple 48 mL • 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 aerobic and anaerobic = culture bottles 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. 8 Not to be Reproduced
FDA Guidance on Bacterial Safety 9/30/19 (One Step Strategies) 1 0 1 2 3 4 5 6 7 Day PATHOGEN REDUCTION (PR) 1 Available for transfusion PR process 2 LARGE VOLUME, DELAYED SAMPLING (LVDS) AT ≥36HR 2 Hold Available for transfusion Sample ≥36h ≥12h 16mL total per final product aerobic + anaerobic LARGE VOLUME, DELAYED SAMPLING (LVDS) AT ≥ 48HR 3,4 3 Hold Available for transfusion Sample ≥48h ≥12h 16mL total per final product aerobic + anaerobic 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. Not to be Reproduced 9
Age Distribution of Transfused Platelet Components – INTERCEPT Platelets versus Conventional Platelets 10 Not to be Reproduced
Key Metrics for Comparison of Single Step Strategies Days of Culture Delay Hours to Available Transfusion Single Step Strategy Hours of Hold Time Follow Up Transfusion Time (days) INTERCEPT ≤ 24 0 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 11 Not to be Reproduced
Vivek Jayaraman Chief Commercial Officer 12 Not to be Reproduced
Kevin D. Green Chief Financial Officer 13 Not to be Reproduced
William ‘Obi’ Greenman President and Chief Executive Officer 14 Not to be Reproduced
Question & Answers 15 Not to be Reproduced
Cerus Corporation Investor Relations IR@cerus.com (925) 288 -6137 Not to be Reproduced
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