79446a006708c4f3d6d77324379c39ef970e0ab82ef5a65737d08e1d4ccd2ab6

Adjustments for Non-Cash Items (USD, thousands)

Stock-Based Compensation (USD, thousands)

Changes in Working Capital (USD, thousands)

Capital Expenditures (USD, thousands)

Proceeds from / Repayments of Debt (USD, thousands)

Share Repurchases (USD, thousands)

Dividend Payments (USD, thousands)

Net Change in Cash (USD, thousands)

14c79712dbb74c653d7f9951a95ed958d63a7014d4d90f8b4654797e9f903093

3c79eea5723de8c2b4e8e4c111a524eaa9970ce47bcd82685eb867c1731341e0

| Name              | Position                                      | Start Date       | Short Bio                                                                                                                                                                                                                                                                                                                                                   |
|-------------------|----------------------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| William M. Greenman | President, Chief Executive Officer, and Director | April 2011       | Joined Cerus in **1995** as Director of Business Development. Held roles including Senior VP of Business Development and Marketing, Chief Business Officer, and President of Cerus Europe. Holds a B.A.S. in economics and biological sciences from Stanford University.  **[0000950170-24-048801_cers-20240419.htm:19]** **[0000950170-23-015609_cers-20230424.htm:14]** **[0000950170-24-048801_cers-20240419.htm:68]**                                                                           |
| Kevin D. Green    | Vice President, Finance, and Chief Financial Officer | February 2013    | Previously served as VP, Finance and Chief Accounting Officer from **March 2009**. Held financial management roles at Macromedia, Inc. from **2000 to 2006**. Certified public accountant with a BS in Accounting from California State University, Fresno.  **[0000950170-24-048801_cers-20240419.htm:68]** **[0000950170-23-015609_cers-20230424.htm:67]**                                                                                           |
| Vivek Jayaraman   | Chief Operating Officer                      | March 2020       | Previously Chief Commercial Officer from **August 2016**. Held leadership roles at TriVascular Technologies, Inc. and Medtronic, Inc. Holds an MBA from the Wharton School and dual bachelor’s degrees from the University of Michigan.  **[0000950170-24-048801_cers-20240419.htm:68]** **[0000950170-23-015609_cers-20230424.htm:67]**                                                                                                             |
| Richard Benjamin  | Chief Medical Officer                        | July 2015        | Former Chief Medical Officer for the American Red Cross (**2006–2015**). Board Member and Regional Director for North America for the International Society of Blood Transfusion. Adjunct Full Professor of Pathology at Georgetown University. Holds a Ph.D. from Cambridge University and completed post-doctoral research at Stanford University.  **[0000950170-23-015609_cers-20230424.htm:67]** **[0000950170-24-048801_cers-20240419.htm:68]**  |
| Chrystal Jensen   | Chief Legal Officer and General Counsel      | December 2012    | Former Senior Corporate Counsel at Zynga Inc. (**2011–2012**) and partner at Cooley LLP. Specializes in corporate and securities law. Holds a BS from the University of Colorado and a JD from the University of Chicago.  **[0000950170-24-048801_cers-20240419.htm:68]** **[0000950170-23-015609_cers-20230424.htm:68]**                                                                                                                             |
| Carol M. Moore    | Senior Vice President, Regulatory Affairs and Quality | February 2013    | Previously VP, Regulatory Affairs, Quality and Clinical (**2008–2013**). Held roles at Bayer Corporation, including VP, Worldwide Regulatory Affairs. Focused on registration and compliance of biological and biotech products. Holds a BS in Biological Science from California State University, Hayward.  **[0000950170-24-048801_cers-20240419.htm:69]** **[0000950170-23-015609_cers-20230424.htm:68]** **[0001193125-22-114637_d266263ddef14a.htm:58]**                                       |
| Dean Gregory      | Member, Board of Directors                   | July 1, 2024 (expected) | Brings over **30 years of experience** in global blood transfusion and cell therapy. Former President, Global Commercial Operations, Med Tech at Fresenius Kabi. Held leadership roles at Fenwal Inc. and Baxter International. Focused on commercialization, product development, and strategy in transfusion medicine and cell therapy.  **[0000950170-24-080426_cers-ex99_1.htm:0]** **[0000950170-24-080426_cers-20240701.htm:1]**               |

04905b25a35d967699377151d699bae3d696efd23c7eb90bf176131cf31f867d

1. With your gross margins expected to remain relatively stable near current levels, what specific strategies do you have to significantly improve margins moving forward?
2. Given that a significant portion of your R&D expenses are funded by BARDA, how are you preparing for potential fluctuations in government funding, and what steps are you taking to mitigate risks associated with this dependency?
3. Considering the anticipated regulatory approval of the LED illuminator in Europe in 2025 and the PMA submission in the U.S. in 2026, how does this timeline affect your competitive positioning, and what measures are you taking to address any potential market challenges?
4. As demand for INTERCEPT Fibrinogen Complex (IFC) grows, do you anticipate any manufacturing capacity constraints, and how might these impact your ability to meet customer demand and revenue growth targets?
5. With the completion of the ReCePI trial and the planned conclusion of the RedeS trial, how do you plan to offset the potential decrease in government contract revenue and sustain growth in this area?

bf3d0e294cea6edbab4bfa4bca27857d07731560f897f6bd9bee8efa20882354

Shelf Life of Platelet Kits (U.S.) [Months]

Shelf Life of Platelet Kits (Global) [Months]

Shelf Life of Platelet Kits (Global) Extended [Months]

Shelf Life of Plasma Kits [Months]

Shelf Life of Plasma Kits Extended [Months]

Shelf Life of IFC Product [Days]

FDA Agreement Value [$ Million]

DoD Agreement Value [$ Million]

BARDA Committed Funding [$ Million]

BARDA Total Funding Opportunity [$ Million]

cf708486bae12a406c13e58cc10094ab7eacdc52c4c17da53cdebf2286522189

- **Expansion into key international markets faces delays and uncertainties**: Cerus' joint venture in China may require a local clinical study, and the opportunity is expected to materialize towards the back part of this decade, indicating potential delays in revenue generation from this market. \[11\]
- **Full implementation of INTERCEPT in Héma-Québec not expected until 2026**: While validation is effectively complete, initial pathogen reduction is anticipated in 2025, with full implementation delayed until 2026, postponing potential revenue growth from this customer. \[13\]
- **Delays in European approval of INTERCEPT red blood cell system**: The company is still awaiting a response from the Netherlands' competent authority (CBG-MEB), which may delay the approval process and impact the timeline for product launch and revenue realization in Europe. \[15\]

d0bbb1b814e7a468c0e4e283bd3b38418c6907b6cc77b8dc55255436e0660766

Cerus Corporation (**CERS**) is a biomedical products company dedicated to enhancing the safety of the global blood supply. The company develops and commercializes the **INTERCEPT Blood System**, a proprietary technology designed to reduce blood-borne pathogens and donor leukocytes in blood components intended for transfusion. Cerus operates globally, selling its products in regions such as the United States, Europe, the Middle East, and Latin America, with a focus on pathogen reduction in platelets, plasma, and red blood cells.

1. **INTERCEPT Blood System for Platelets and Plasma** - Reduces pathogens in platelets and plasma to ensure safer transfusions. Approved by the FDA in the U.S. and certified in the EU, it is marketed globally.  **[0000950170-24-048801_cers-20240419.htm:71]** **[0000950170-24-089390_cers-20240630.htm:30]**   
   - **Disposable Kits** - Used for pathogen reduction during blood processing.  **[0000950170-24-052296_cers-20240331.htm:30]** **[0000950170-24-089390_cers-20240630.htm:6]**   
   - **UVA Illumination Devices** - Supports the pathogen reduction process.  **[0000950170-24-052296_cers-20240331.htm:30]** **[0000950170-24-089390_cers-20240630.htm:6]**   
   - **Maintenance Services** - Includes spare parts and storage solutions for illuminators.  **[0000950170-24-052296_cers-20240331.htm:30]** **[0000950170-24-089390_cers-20240630.htm:6]**   

2. **INTERCEPT Blood System for Cryoprecipitation** - Produces INTERCEPT Fibrinogen Complex (IFC) for treating bleeding disorders and pathogen-reduced plasma, cryoprecipitate reduced. Approved by the FDA for use in the U.S..  **[0000950170-24-048801_cers-20240419.htm:71]** 

3. **INTERCEPT Blood System for Red Blood Cells** - Currently in development, this system is undergoing Phase 3 clinical trials in the U.S. and has a pending CE Certificate of Conformity application in the EU. It aims to reduce pathogens in red blood cells for transfusion.  **[0000950170-24-048801_cers-20240419.htm:71]**

b6392be9cec48cfbb8b486f7cc7a1c592f005ba5f351bb76a90c9785b54273c1

23794d91c53ae875c8e247d72561e35d9d06ee07c70c9e0dbcc977a6d161504a

Product Revenue

Government Grants and Cooperative Agreements Revenue

Government Contract Revenue

Total Revenue

2c1519ef45163d7f3ac08733cab9315d4cf3a0c5877d4af2d4eeb4635a04d339

### **Q3 2024 Earnings Call**
- **Issued Period**: Q3 2024  
- **Guided Period**: FY 2024  
- **Guidance**:  
  1. **Full-Year 2024 Product Revenue Guidance**: Revised upward to **$177 million to $179 million**, up from the prior range of **$175 million to $178 million**.  **[CERS_3405016_6]**   
  2. **Full-Year 2024 INTERCEPT Fibrinogen Complex (IFC) Revenue Guidance**: Revised upward to **$9 million to $10 million**, up from the prior range of **$8 million to $10 million**.  **[CERS_3405016_6]**   
  3. **Gross Margins**: Expected to remain close to Q3 2024 levels of **56.9%** for the balance of the year.  **[CERS_3405016_5]**   
  4. **Adjusted EBITDA**: Expected to deliver **positive adjusted EBITDA** for FY 2024.  **[CERS_3405016_6]**   
  5. **Operating Expenses**:  
     - SG&A expenses: No significant swings anticipated for the remainder of 2024.  **[CERS_3405016_6]**   
     - R&D expenses: Expected to see a **modest increase** in Q4 2024 due to ramping enrollment in the RedeS clinical study and activities under the new BARDA contract.  **[CERS_3405016_5]** 

### **Q2 2024 Earnings Call**
- **Issued Period**: Q2 2024  
- **Guided Period**: FY 2024  
- **Guidance**:  
  1. **Full-Year 2024 Product Revenue Guidance**: Raised to **$175 million to $178 million**, up from the prior range of **$172 million to $175 million**.  **[CERS_3395855_6]** **[CERS_3395855_1]**   
  2. **Full-Year 2024 IFC Revenue Guidance**: Reiterated at **$8 million to $10 million**.  **[CERS_3395855_6]** **[CERS_3395855_1]**   
  3. **Adjusted EBITDA**: Committed to achieving **positive adjusted EBITDA** for FY 2024.  **[CERS_3395855_2]** **[CERS_3395855_6]**   
  4. **Gross Margins**: Expected to remain stable at approximately Q2 levels (**54.7%**) for the balance of the year.  **[CERS_3395855_5]**   
  5. **Operating Expenses**:  
     - SG&A expenses: No significant swings anticipated for the remainder of 2024, with continued leverage expected.  **[CERS_3395855_5]**   

### **Q1 2024 Earnings Call**
- **Issued Period**: Q1 2024  
- **Guided Period**: FY 2024  
- **Guidance**:  
  1. **Full-Year 2024 Product Revenue Guidance**: Expected to be **$172 million to $175 million**, reflecting **double-digit growth** from 2023 levels.  **[CERS_3382226_6]** **[CERS_3382226_1]**   
  2. **Full-Year 2024 IFC Revenue Guidance**: Expected to be **$8 million to $10 million**, representing growth of approximately **25% to 50%** compared to 2023 IFC sales.  **[CERS_3382226_6]** **[CERS_3382226_1]**   
  3. **Non-GAAP Adjusted EBITDA**: Committed to achieving **adjusted EBITDA breakeven** for FY 2024.  **[CERS_3382226_1]** **[CERS_3382226_4]**   
  4. **Operating Cash Flow**: Anticipates potentially generating **positive operating cash flows** for FY 2024, with some possible quarterly fluctuations.  **[CERS_3382226_5]** 

### **Q4 2023 Earnings Call**
- **Issued Period**: Q4 2023  
- **Guided Period**: FY 2024  
- **Guidance**:  
  1. **2024 Product Revenue Guidance**: Expected to be **$172 million to $175 million**, reflecting double-digit growth from 2023.  **[CERS_3376465_4]**   
  2. **2024 IFC Revenue Guidance**: Expected to be **$8 million to $10 million**.  **[CERS_3376465_5]**   
  3. **Non-GAAP Adjusted EBITDA**: Aims to sustain or improve upon the positive non-GAAP adjusted EBITDA achieved in Q4 2023 for FY 2024, though some quarter-to-quarter fluctuations are expected.  **[CERS_3376465_3]** **[CERS_3376465_4]**   
  4. **Operating Cash Flows**: Expects improvements in operating cash flows for FY 2024 and potentially achieving **positive operating cash flows** for the year.  **[CERS_3376465_4]** 

0f7c28e3e989235c68d41a3670a7125ae20cb580b200c859ab80fa523434cd77

- **Uncertain Growth in EMEA Markets**: The company acknowledges challenges in its EMEA region, with revenue declining over several years. Growth depends on new geographies, but it is hard to predict when large accounts will come online, indicating potential difficulties in achieving future growth in these markets.  **[CERS_3382226_15]**
- **Slow Adoption in Key European Countries**: Adoption of INTERCEPT products in important markets like the UK and Germany is progressing slowly. In the UK, market conversion is uncertain and hard to predict. In Germany, progress is slow, and adoption depends on extended shelf life claims, potentially impacting revenue growth.  **[CERS_3382226_14]**
- **Regulatory Uncertainties in China**: The company faces uncertainties in obtaining regulatory approval in China. They are waiting for feedback from the NMPA and cannot provide clarity on the timing for approval, which could delay market entry and affect future revenues.  **[CERS_3382226_9]**

d10e63420d5558af2b94de4169c3d34243e8e2c4ae9d07266e78941ef3700b4f

1. **IFC Growth Outlook for 2025**  
   **Q:** How should we think about IFC growth in 2025?  
   **A:** Management anticipates continued growth in IFC driven by both new customer acquisition and expanding usage within existing accounts. With approximately **55-60% of customers added this calendar year**  **[CERS_3405016_10]** , recent BLA approvals enhance supply capacity to meet growing demand.  **[CERS_3405016_11]**  Hospitals recovering from COVID are now more open to adopting new projects like IFC, creating meaningful tailwinds for 2025.  **[CERS_3405016_11]** 

2. **Manufacturing Capacity for IFC**  
   **Q:** Do you need more manufacturing capacity for growing IFC demand?  
   **A:** As demand for IFC grows, Cerus continues to work with blood centers to add manufacturers.  **[CERS_3405016_8]**  The addition of **three BLAs in the quarter** is significant to ensure they can meet increasing demand, and they plan to recruit and partner with more blood centers to produce IFC.  **[CERS_3405016_8]** 

3. **LED Illuminator Approval Timeline**  
   **Q:** What's the timeline for LED illuminator approval and launch?  
   **A:** Cerus is targeting a European launch of the LED illuminator in **2025**.  **[CERS_3405016_9]**  They plan to roll it out across multiple customers throughout 2025 and '26 in Europe. A PMA submission in the U.S. is likely to take place around **2026**.  **[CERS_3405016_9]** 

4. **Impact of LED Illuminator on Margins**  
   **Q:** Will the LED illuminator affect gross margins?  
   **A:** The LED illuminator technology is newer with slightly higher COGS and ASPs.  **[CERS_3405016_15]**  The margins on this product are expected to be **neutral** to current margins. It provides a platform for future growth and potential product iterations.  **[CERS_3405016_15]** 

5. **Government Contract Revenue and BARDA**  
   **Q:** How should we think about government contract revenue and the new BARDA contract?  
   **A:** The **2016 BARDA contract** had lighter revenues due to study completion.  **[CERS_3405016_17]**  As new sites ramp up, revenues and associated expenses will **increase over the next 12-15 months**.  **[CERS_3405016_17]**  Activities under the new **2024 BARDA contract**, with **$32 million** committed over several years, will begin in earnest in **2025**.  **[CERS_3405016_17]** 

6. **Sustainability of Cash Flow**  
   **Q:** How sustainable is cash flow going forward?  
   **A:** Cerus expects to generate operating cash flows as a result of top-line growth, margin management, and OpEx leverage.  **[CERS_3405016_19]**  Inventory built in 2023 can be converted into finished kits without replenishing, aiding cash flows.  **[CERS_3405016_19]**  In 2025, working capital will need to be rebuilt to meet growing demand, but this should be offset by operating income.  **[CERS_3405016_19]** 

7. **R&D Expenses and Funding**  
   **Q:** To what extent are R&D expenses funded by BARDA?  
   **A:** A significant portion of R&D expenses are funded by BARDA, especially with multiple agreements in place.  **[CERS_3405016_20]**  Initiatives like the whole blood program and lyophilized IFC are major components. Remaining expenses are for foundational initiatives like the LED illuminator.  **[CERS_3405016_20]** 

8. **Uses of Cash Going Forward**  
   **Q:** What are other uses of cash we should consider?  
   **A:** Cerus plans to manage working capital, potentially leveraging their revolving line of credit.  **[CERS_3405016_21]**  Other uses include CapEx for **COGS reduction initiatives**, capacity expansion, and geographic expansion, which are viewed as high-return investments.  **[CERS_3405016_21]** 

9. **Adjusted EBITDA and Guidance Conservatism**  
   **Q:** Is the full-year adjusted EBITDA guidance conservative?  
   **A:** While tracking slightly better than neutral guidance, management maintains caution due to many moving parts.  **[CERS_3405016_18]**  They expect growth with increased revenue guidance, sustaining gross margins, and continued OpEx leverage.  **[CERS_3405016_18]**  Variability in operating expenses and margins drives a conservative stance.  **[CERS_3405016_18]** 

10. **Value Proposition of LED Illuminator**  
    **Q:** What is the value proposition of the LED illuminator for customers?  
    **A:** The LED illuminator offers improved **throughput and ease of use**.  **[CERS_3405016_13]**  It ensures supply chain continuity and reliable performance, which is critical for customers processing hundreds of units daily.  **[CERS_3405016_13]**  It's a foundational platform for future technological evolution, potentially impacting COGS positively.  **[CERS_3405016_13]** 

11. **Future BLA Approvals for IFC**  
    **Q:** Should we expect more BLA approvals for IFC?  
    **A:** Cerus anticipates more BLAs to come through in **2025 and beyond**.  **[CERS_3405016_14]**  Other blood center partners are preparing BLA applications, and the timing may vary.  **[CERS_3405016_14]**  Recent approvals provide sufficient capacity to aggressively drive demand.  **[CERS_3405016_14]** 

12. **Intellectual Property Extension**  
    **Q:** Does the LED illuminator extend IP protection?  
    **A:** Yes, the development of the LED illuminator over the past **five years** has generated significant IP, extending the company's moat.  **[CERS_3405016_16]**  This IP is filed globally, improving the product's IP profile worldwide.  **[CERS_3405016_16]** 

01800b2f58f9596edfff70a72fc10167620070cc64d9a54b2ecfd4d18f52a01d

- **Significant dependence on government funding for R&D**: The company heavily relies on government contracts, such as BARDA agreements, to fund a substantial portion of its R&D expenses. Kevin Green stated, "Almost a majority of our R&D expenses are funded by BARDA... The remaining items are initiatives that are foundational to our future growth and revenue trajectory, like the LED illuminator... We're not done planning and we're not providing guidance today."  **[CERS_3405016_20]**
- **New LED illuminator may not improve profit margins**: The upcoming LED illuminator is expected to have higher cost of goods sold (COGS), and margins are anticipated to be neutral rather than accretive. Kevin Green mentioned, "The technology is newer. The COGS will be slightly higher... We expect that the margins on that product will be neutral to our current margin business."  **[CERS_3405016_16]**
- **Conservative guidance despite beating estimates indicates potential uncertainties**: Despite outperforming in Q3, the company maintained conservative full-year adjusted EBITDA guidance due to variability in operating expenses and margins. William Greenman said, "There is variability in operating expenses and margins... So we really want to hedge that as much as possible."  **[CERS_3405016_18]**

e6237e64994a2781e94f33cfd1bc86ebcdfdf388e224a8338ed39c52a4ef9f77

- **Potential quarterly EBITDA volatility**: The company acknowledged that their top-line guidance doesn't suggest linearity and there may be **"chop quarter-to-quarter"** in financial results, suggesting that positive EBITDA may not be sustained every quarter in 2024.  **[CERS_3376465_8]**
- **Uncertainty surrounding the ReCePI study results**: Awaiting unblinding of the ReCePI study data with a **wide non-inferiority margin of 50%**, raising concerns about the study's ability to demonstrate desired outcomes and potential impact on future regulatory approvals.  **[CERS_3376465_12]**
- **Regulatory delays in China could impact growth**: Experiencing **delays** in the regulatory approval process in China, with the company noting they are **"not complete with the review yet"**, which may affect international expansion plans.  **[CERS_3376465_9]**

b11f2c5f63e719d4ad3db74cee04ed854d6f70bd2006c91fc8728c55958a6ee5

- **Cerus Corporation raised its full-year 2024 product revenue guidance to $175 million to $178 million**, up from the previous range of $172 million to $175 million, driven by strong growth in the U.S. platelet business.  **[CERS_3395855_1]**
- **The company achieved positive adjusted EBITDA of just under $1 million in Q2 2024**, a significant improvement from a loss of $4.7 million in the prior year period, and is confident in achieving positive adjusted EBITDA for the full year.  **[CERS_3395855_6]**
- **Growing demand for INTERCEPT Fibrinogen Complex (IFC) presents a significant growth opportunity**, with increasing hospital adoption and positive clinical validation supporting future sales.  **[CERS_3395855_11]**

58b83dd841bd7c8106fb81ec8683a8940a34f1787361655e4a997d1fe69a3d5f

- **Cerus anticipates delivering double-digit growth throughout the rest of 2024 and is increasingly confident in meeting or exceeding its full-year revenue guidance.**  **[CERS_3382226_7]** **[CERS_3382226_10]**
- **The company generated positive operating cash flows of **$2 million** for Q1 and believes it can potentially generate positive operating cash flows for 2024 as a whole.**  **[CERS_3382226_17]**
- **Significant growth opportunities exist in new geographies, including Germany, the Middle East, and potentially the UK, which could provide upside to revenue.**  **[CERS_3382226_15]** **[CERS_3382226_14]** **[CERS_3382226_12]**

e172700605bda5ed5b187ee8d0de8b4de98cf16f4b6ea4efd5caca2afd18339e

- **Strong momentum in IFC adoption**, with growth driven by both new customer acquisitions and deeper penetration in existing accounts; **approximately 55%-60% of customers were added this calendar year**, and some institutions are now at **100% IFC usage across all clinical departments**, indicating significant growth potential for this therapeutic category.  **[CERS_3405016_10]**
- **Upcoming launch of the LED illuminator in Europe in 2025**, viewed as a foundational new platform for the business and the use of platelets and plasma in blood centers, with plans to roll out across multiple customers in 2025 and 2026, followed by a PMA submission in the U.S. in 2026; this innovation is expected to improve future processes and drive growth.  **[CERS_3405016_9]**
- **Strong financial outlook**, with **increased revenue guidance**, expecting growth, sustaining gross margins, and continued leverage in operating expenses; the company is trending in the right direction and is **optimistic about the future**, focusing on high-return investments in capacity expansion and geographic expansion, which are beneficial to shareholders.  **[CERS_3405016_18]** **[CERS_3405016_21]**

1b26dd0427282ca71ed759939c24b16b28ae26d1f73533f89499ee739c6b11d3

- **Achieved positive adjusted EBITDA of $5 million in Q4 2023**, marking the first time in the company's history, and expects to sustain or improve this measure in 2024.  **[CERS_3376465_8]**
- **Projected strong growth in the INTERCEPT Fibrinogen Complex (IFC) business**, with 2024 revenue guidance of **$8 million to $10 million**, representing **30% to 50% growth** over the prior year, addressing a total addressable market of **$200 million to $300 million**.  **[CERS_3376465_7]**
- **International expansion opportunities** in Canada, Germany, the Middle East, and pending regulatory approval in China, are expected to drive further growth in 2024.  **[CERS_3376465_9]**

cb78a399e95f7bbf8d58984a94f40c90a70f1f336fd04c7ba08563325e357d5d

Cerus Corp (CERS)

Financials