EX-99.1 2 d220853dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

Cerus Corporation Announces Record Third Quarter 2021 Financial Results and Raises

Full-Year Product Revenue Guidance

Accelerating Revenue Growth Driven by U.S. Adoption of INTERCEPT Platelets

Total Revenue of $42.1 Million Grew 44% in the Third Quarter

Product Revenue of $36.1 Million Grew 53% in the Third Quarter

Full-Year 2021 Product Revenue Guidance Range Raised to $127-129 Million

CONCORD, CA, November 2, 2021 - Cerus Corporation (Nasdaq: CERS) today announced financial results for the third quarter ended September 30, 2021.

Recent developments and highlights include:

 

   

Third quarter 2021 total revenue of $42.1 million, reflecting a 44% increase over the prior year period. Total revenue was composed of (in thousands, except %):

 

     Three Months Ended
September 30,
           Nine Months Ended
September 30,
        
     2021      2020      Change     2021      2020      Change  

Product revenue

   $ 36,131        23,607        53   $ 90,994        63,721        43

Government contract revenue

     5,970        5,584        7     18,436        16,938        9
  

 

 

    

 

 

      

 

 

    

 

 

    

Total revenue

   $ 42,101        29,191        44   $ 109,430        80,659        36
  

 

 

    

 

 

      

 

 

    

 

 

    

 

   

As of the date of this release, the Company is increasing its 2021 annual product revenue guidance range to $127 million to $129 million (from the prior guidance of $118 million to $122 million), representing an approximate 38% to 40% increase over full year 2020 reported product revenue.

 

   

On October 1, 2021, the U.S. Food and Drug Administration’s (FDA) final guidance document on bacterial risk control strategies for platelet collection and transfusion was made effective. This guidance for the industry identifies FDA-approved pathogen reduction as a means of compliance.

 

   

Cerus achieved cumulative sales for the INTERCEPT Blood System for platelets and plasma that have surpassed 10 million treatable doses globally since the products were first commercially launched.

 

   

Cash, cash equivalents, and short-term investments were $120 million at September 30, 2021.

“Cerus’ third quarter results represent a strong commercial achievement for the Company, in particular with regard to the U.S. platelet business. With quarterly product revenue of $36.1 million and sales momentum that continues into the fourth quarter, I am pleased that adoption of the INTERCEPT Blood

 


System for platelets is establishing a new standard of care,” said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. “With solid visibility to continued demand for the balance of the year, we are raising our product revenue guidance and look forward to finishing this breakout year for Cerus on a strong note.”

Revenue

Product revenue during the third quarter of 2021 was $36.1 million, compared to $23.6 million during the same period in 2020. Product revenue growth during the quarter was driven by increased sales of INTERCEPT platelet products to blood center customers across the U.S.

Third quarter government contract revenue was $6.0 million, compared to $5.6 million during the same period in 2020. Third quarter government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Cells as well as sponsored efforts related to the development of next generation pathogen reduction technology to treat whole blood.

Product Gross Profit & Margin

Product gross profit for the third quarter 2021 was $18.5 million and was the highest in company history, reflecting a nearly $6 million increase over the same period in 2020. Product gross margin for the third quarter 2021 was 51.3% compared to 53.6% for the third quarter of 2020 and flat compared to the second quarter of 2021. The anticipated decrease in product gross margin compared to the third quarter of 2020 was tied to higher sales to U.S. customers during the quarter, who at present, primarily use the Company’s single dose platelet kits, which provide a lower product gross margin percentage compared to our double dose kits that are more frequently used internationally.

Operating Expenses

Total operating expenses for the third quarter of 2021 were $35.6 million compared to $32.2 million for the same period of the prior year. In general, the increase in operating expenses compared to the prior year period were driven by higher commercial expenses, due to sales incentive compensation and partially offset by lower R&D expenses.

Selling, general, and administrative (SG&A) expenses for the third quarter of 2021 totaled $20.4 million, compared to $16.3 million for the third quarter of 2020. The year-over-year increase in SG&A expenses was tied to increased sales costs and continued investments in our therapeutics business unit.

R&D expenses for the third quarter of 2021 were $15.3 million, compared to $15.9 million for the third quarter of 2020. Continued investments in a variety of R&D pipeline projects continued during the quarter, including those related to the Company’s LED illuminator, but were offset by lower R&D costs versus the prior year period associated with mature projects that have been completed.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the third quarter of 2021 was $12.4 million, or $0.07 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $14.1 million, or $0.08 per basic and diluted share, for the third quarter of 2020.

Balance Sheet

At September 30, 2021, the Company had cash, cash equivalents and short-term investments of $120.0 million, compared to $122.8 million at June 30, 2021 and $133.6 million at December 31, 2020. Despite continued investments in inventory to meet the anticipated growth in demand, cash used from operations continued to decline as the Company realized increased revenue contribution and significant leverage in SG&A spend.

 

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As of September 30, 2021, the Company carried $55 million of notes due and a balance on its revolving line of credit of $10 million. The Company continues to have access to another $15 million under its term facility and capacity for an additional $10 million under its revolving line of credit.

Increasing 2021 Product Revenue Guidance

Based on the strong product revenue year to date and updated demand estimates heading into the remainder of the Company’s fourth quarter, the Company now expects 2021 product revenue to be in the range of $127 million to $129 million, compared to the prior range of $118 million to $122 million. The revised guidance range represents approximately 38% to 40% growth over 2020 reported product revenue.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir. Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 3970817. The replay will be available approximately three hours after the call through November 16, 2021.

ABOUT CERUS

Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE Mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

Forward Looking Statements

Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements relating to Cerus’ updated 2021 annual product revenue guidance, including Cerus’ expectation of continued demand for the balance of 2021; Cerus establishing the INTERCEPT Blood System as a standard of care; Cerus’ ability to access additional funding under its term loan facility and revolving line of credit; and other statements that are not historical fact. Actual results could differ materially from these

 

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forward-looking statements as a result of certain factors, including, without limitation: risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, including the risks that Cerus may not (a) meet its updated 2021 annual product revenue guidance, (b) effectively launch and commercialize the INTERCEPT Blood System for Cryoprecipitation, (c) grow sales globally, including in its U.S. and European markets, and/or realize expected revenue contribution resulting from its U.S. and European market agreements, (d) realize meaningful and/or increasing revenue contributions from U.S. customers in the near term or at all, particularly since Cerus cannot guarantee the volume or timing of commercial purchases, if any, that its U.S. customers may make under Cerus’ commercial agreements with these customers, (e) effectively expand its commercialization activities into additional geographies and/or (f) realize any revenue contribution from its pipeline product candidates, whether due to Cerus’ inability to obtain regulatory approval of its pipeline programs, or otherwise; risks associated with the ultimate duration and severity of the COVID-19 pandemic and resulting global economic and financial disruptions, and the current and potential future negative impacts to Cerus’ business operations and financial results such as the current and potential additional disruptions to the U.S. and EMEA blood supply resulting from the evolving effects of the COVID-19 pandemic; risks associated with Cerus’ lack of commercialization experience with the INTERCEPT Blood System for Cryoprecipitation and in the United States generally, and its ability to develop and maintain an effective and qualified U.S.-based commercial organization, as well as the resulting uncertainty of its ability to achieve market acceptance of and otherwise successfully commercialize the INTERCEPT Blood System in the United States, including as a result of licensure requirements that must be satisfied by U.S. customers prior to their engaging in interstate transport of blood components processed using the INTERCEPT Blood System; risks related to Fresenius Kabi’s efforts to assure an uninterrupted supply of platelet additive solution (PAS); risks related to how any future PAS supply disruption could affect INTERCEPT’s acceptance in the marketplace; risks related to how any future PAS supply disruption might affect current commercial contracts; risks related to Cerus’ ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction, including INTERCEPT Fibrinogen Complex for the treatment and control of bleeding, and the INTERCEPT Blood System is safe, effective and economical; risks related to the uncertain and time- consuming development and regulatory process, including the risks that (a) Cerus may be unable to comply with the FDA’s post-approval requirements for the INTERCEPT Blood System, including by successfully completing required post-approval studies, which could result in a loss of U.S. marketing approval(s) for the INTERCEPT Blood System, (b) manufacturing site Biologics License Applications necessary for Cerus to distribute the INTERCEPT Blood System for Cryoprecipitation may not be obtained in a timely manner or at all, and (c) Cerus may be unable to obtain the requisite regulatory approvals to advance its pipeline programs and bring them to market in a timely manner or at all; risks associated with the uncertain nature of BARDA’s funding over which Cerus has no control as well as actions of Congress and governmental agencies that may adversely affect the availability of funding under Cerus’ BARDA agreement and/or BARDA’s exercise of any potential subsequent option periods, including in connection with the general economic environment and uncertainty associated with the evolving effects of the COVID-19 pandemic, such that the anticipated activities that Cerus expects to conduct with the funds available from BARDA may be further delayed or halted and that Cerus may not otherwise realize the total potential value under its agreement with BARDA; risks related to product safety, including the risk that the septic platelet transfusions may not be avoidable with the INTERCEPT Blood System; risks related to adverse market and economic conditions, including continued or more severe adverse fluctuations in foreign exchange rates and/or continued or more severe weakening in economic conditions resulting from the evolving effects of the COVID-19 pandemic or otherwise in the markets where Cerus currently sells and is anticipated to sell its products; Cerus’ reliance on third parties to market, sell, distribute and maintain its products; Cerus’ ability to maintain an effective, secure manufacturing supply chain, including the risks that (a) Cerus’ supply chain could be negatively impacted as a result of the evolving effects of the COVID-19 pandemic, (b) Cerus’ manufacturers could be unable to comply with extensive FDA and

 

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foreign regulatory agency requirements, and (c) Cerus may be unable to maintain its primary kit manufacturing agreement and its other supply agreements with its third party suppliers; Cerus’ ability to identify and obtain additional partners to manufacture the INTERCEPT Blood System for Cryoprecipitation; risks associated with Cerus’ ability to access additional funds under its term loan facility and revolving line of credit and to meet its debt service obligations, and its need for additional funding; the impact of legislative or regulatory healthcare reforms that may make it more difficult and costly for Cerus to produce, market and distribute its products; risks related to future opportunities and plans, including the uncertainty of Cerus’ future capital requirements and its future revenues and other financial performance and results, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Cerus’ Quarterly Report on Form 10-Q, filed with the SEC on August 3, 2021, and future filings and reports by Cerus. In addition, to the extent that the COVID-19 pandemic adversely affects Cerus’ business and financial results, it may also have the effect of heightening many of the other risks and uncertainties described above. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

Contact:

Matt Notarianni – Senior Director, Investor Relations

Cerus Corporation

925-288-6137

Supplemental Tables

 

     Three Months Ended     Nine Months Ended  
     September 30,     September 30,  
     2021 vs. 2020     2021 vs. 2020  

Platelet Kit Growth

 

U.S.

     168     127

International

     5     5

Worldwide

     82     58

Change in Calculated Number of Treatable Platelet Doses*

 

U.S.

     162     124

International

     5     5

Worldwide

     69     50

 

*

Dose treatable calculation based on the number of kits sold and the product configuration (single, double, and triple dose kits)

 

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CERUS CORPORATION

REVENUE BY REGION

(in thousands, except percentages)

 

     Three Months Ended                  Nine Months Ended               
     September 30,      Change     September 30,      Change  
     2021      2020      $     %     2021      2020      $     %  

North America

   $ 20,860      $ 8,465      $ 12,395       146   $ 45,171      $ 20,942      $ 24,229       116

Europe, Middle East and Africa

     14,965        14,527        438       3     44,473        41,210        3,263       8

Other

     306        615        (309     -50     1,350        1,569        (219     -14
  

 

 

    

 

 

    

 

 

     

 

 

    

 

 

    

 

 

   

Total product revenue

   $ 36,131      $ 23,607      $ 12,524       53   $ 90,994      $ 63,721      $ 27,273       43
  

 

 

    

 

 

    

 

 

     

 

 

    

 

 

    

 

 

   

CERUS CORPORATION

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

(in thousands, except per share information)

 

     Three Months Ended     Nine Months Ended  
     September 30,     September 30,  
     2021     2020     2021     2020  

Product revenue

   $ 36,131     $ 23,607     $ 90,994     $ 63,721  

Cost of product revenue

     17,582       10,953       44,000       28,978  
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit on product revenue

     18,549       12,654       46,994       34,743  
  

 

 

   

 

 

   

 

 

   

 

 

 

Government contract revenue

     5,970       5,584       18,436       16,938  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Research and development

     15,288       15,921       48,119       47,349  

Selling, general and administrative

     20,357       16,299       59,285       48,324  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     35,645       32,220       107,404       95,673  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (11,126     (13,982     (41,974     (43,992

Total non-operating expense, net

     (1,238     (89     (3,033     (1,292
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (12,364     (14,071     (45,007     (45,284

Provision for income taxes

     73       68       248       192  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

     (12,437     (14,139     (45,255     (45,476

Net loss attributable to noncontrolling interest

     —         —         —         —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to Cerus Corporation

   $ (12,437   $ (14,139   $ (45,255   $ (45,476
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to Cerus Corporation:

        

Basic and diluted

   $ (0.07   $ (0.08   $ (0.27   $ (0.28

Weighted average shares outstanding:

        

Basic and diluted

     171,904       166,572       170,666       162,800  

 

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CERUS CORPORATION

CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

(in thousands)

 

     September 30,      December 31,  
     2021      2020  
     (unaudited)         
ASSETS      

Current assets:

     

Cash and cash equivalents

   $ 78,460      $ 36,594  

Short-term investments

     41,501        97,000  

Accounts receivable

     22,439        21,166  

Current inventories

     29,420        23,254  

Prepaid and other current assets

     6,232        5,417  
  

 

 

    

 

 

 

Total current assets

     178,052        183,431  

Non-current assets:

     

Property and equipment, net

     12,684        13,867  

Goodwill

     1,316        1,316  

Operating lease right-of-use assets

     12,409        13,122  

Other assets

     14,485        9,679  
  

 

 

    

 

 

 

Total assets

   $ 218,946      $ 221,415  
  

 

 

    

 

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY      

Current liabilities:

     

Accounts payable and accrued liabilities

   $ 52,371      $ 48,966  

Debt – current

     9,986        8,516  

Operating lease liabilities – current

     1,616        1,915  

Deferred product revenue – current

     744        577  
  

 

 

    

 

 

 

Total current liabilities

     64,717        59,974  

Non-current liabilities:

     

Debt – non-current

     54,675        39,588  

Operating lease liabilities – non-current

     16,079        16,873  

Other non-current liabilities

     2,400        1,174  
  

 

 

    

 

 

 

Total liabilities

     137,871        117,609  
  

 

 

    

 

 

 

Cerus Corporation stockholders’ equity

     80,075        103,806  
  

 

 

    

 

 

 

Noncontrolling interest

     1,000        —    
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 218,946      $ 221,415  
  

 

 

    

 

 

 

 

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