• Codexis Reports Second Quarter 2021 Financial Results

    Источник: Nasdaq GlobeNewswire / 05 авг 2021 16:05:03   America/New_York

    Record Product Revenue of $14.7M, up 227% YOY

    Record Product Gross Margin of 71%

    Company Raises Guidance for 2021 Total Revenue to $98 - 103 M and 2021 Product Revenue to $59 - 63 M

    REDWOOD CITY, Calif., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Codexis, Inc. (Nasdaq:CDXS), a leading enzyme engineering company enabling the promise of synthetic biology, today announced financial results for the second quarter ended June 30, 2021 and provided a business update.

    “Codexis had an extraordinarily strong second quarter, with record product revenue that also drove our product gross margin to a new high,” said John Nicols, Codexis President and CEO. “Our Sustainable Manufacturing business showcased Codexis’ ability to translate our decades of R&D work designing high performance enzymes into impressive top line growth. We received a new order from a global pharmaceutical company for commercial-scale quantities of one of Codexis’ proprietary enzymes for delivery in the second half of 2021, which should culminate in the largest annual sales for a product in the Company’s history. In the second quarter, another facet of Codexis’ business model was highlighted by the receipt of a CodeEvolver® platform milestone payment from GlaxoSmithKline (GSK), our largest-ever backend license payment.

    “Our Biotherapeutics business demonstrated its strategic value in Q2, with our partner Takeda expanding the collaboration to a fourth program. In addition to customer-driven projects, we are applying our R&D resources to advance Codexis’ self-funded programs further into development across all of our business segments, in order to capture even greater value in the future. This is a defining period of growth for Codexis, and we look forward to building upon this momentum as our proprietary platform and growing pipeline continue to deliver the promise of synthetic biology to improve the improve the health of people and the planet,” concluded Mr. Nicols.

    Key Performance Indicators and Recent Business Highlights

    • Product revenues increased 227% to $14.7 million in Q2’21, primarily driven by the sale of enzymes used to manufacture branded pharmaceutical products.

    • Product gross margin climbed to 71% in Q2’21, driven by a shift in the sales mix to higher margin products.

    • In the second quarter, Codexis had 22 customers who contributed over $100,000 in revenue, nine of which contributed over $1 million in revenue.

    • In the Sustainable Manufacturing business, Codexis received a significant new order for commercial-scale quantities of a proprietary enzyme from an undisclosed global pharmaceutical company. The Company also earned a CodeEvolver® platform licensing milestone payment from GSK, related to the advancement of the commercialization of an enzyme, engineered by GSK, using CodeEvolver® to improve a key step in the manufacturing process for a currently undisclosed drug. In July, Codexis announced the completion of the technology transfer to Novartis Pharma AG for a non-exclusive license to the CodeEvolver® platform to develop novel performance enzymes for use in the manufacture of pharmaceutical products. In addition, last week the Company announced an expanded commercial supply agreement with Kalsec for an enzyme to sustainably produce their natural clean-label beverage ingredient.

    • In the Life Science Tools market, the Company received an option payment on a program for an enzyme with an undisclosed partner. Customer interest in Codex® HiFi DNA polymerase and Codex® HiCap RNA polymerase remains strong. Codexis continues to drive both partnered and self-funded research and product development, notably making significant technical progress in its enzymatic DNA synthesis collaboration with Molecular Assemblies, which is on track for the enzyme engineering to be completed in the second half of 2021.

    • In the Biotherapeutics segment, Codexis’ pipeline continued to expand during the second quarter as Takeda exercised the option to expand its strategic collaboration for the discovery of additional transgenes for a lysosomal storage disorder gene therapy program. CDX-7108, partnered with Nestlé Health Sciences and targeting an undisclosed GI disorder, has now been filed for approvals with regulatory authorities outside the U.S. for its first clinical trial, which we expect to initiate around the turn of the year.

    Pipeline Update

    Codexis published its annual pipeline snapshot as of June 30, 2021, which is available on the Presentations page of the Company’s investor relations website. Highlights include:

    • Total Number of Programs: The total number of commercial products and pipeline programs as of June 30, 2021 increased to 78 from 65 a year ago.

    • Commercial Products by Market: Codexis had 17 commercial products as of June 30, 2021 (up from 14 a year ago), with 12 in Pharma Manufacturing (up from 11), and 5 in Food and Life Science Tools (up from 3).

    • Pre-Commercial Products by Market: The Company had 61 pre-commercial programs as of June 30, 2021 (up from 51 a year ago), with 24 in late-stage Pharma Manufacturing (flat compared to a year ago); 19 in Life Science Tools, Food & Industrials (up from 13); and 18 in Biotherapeutics (up from 14).

    • Partnered vs Self-Funded Programs: As of June 30, 2021, 45 of Codexis’ pre-commercial programs were partnered (up from 38 a year ago) and 16 were self-funded (up from 13).

    Second Quarter 2021 Financial Highlights

    • Total revenues for the second quarter 2021 were $25.5 million, an increase of 70% from $15.0 million in the second quarter 2020. On a segment basis, $21.6 million in revenue was from the Performance Enzymes segment and $3.9 million was from Biotherapeutics. Product revenues for the second quarter 2021 were $14.7 million compared to $4.5 million in the second quarter 2020; the increase was the result of higher sales of enzymes used to manufacture branded pharmaceutical products. R&D revenues were $10.7 million compared to $10.5 million last year.

    • Product gross margin for the second quarter 2021 was 71% compared to 62% in the second quarter 2020. The increase was driven by increased sales of higher margin products.

    • R&D expenses for the second quarter 2021 were $12.8 million compared to $10.9 million in the second quarter 2020. The increase was driven by higher compensation expenses driven primarily by higher headcount, higher expenses for outside services, cost of lab supplies and depreciation, partially offset by lower preclinical development and regulatory expenses.

    • Selling, General & Administrative expenses for the second quarter 2021 were $12.8 million, compared to $8.5 million in the second quarter 2020. The increase was the result of higher expenses for compensation, primarily driven by higher headcount, and higher legal fees, partially offset by lower allocation expenses.

    • The net loss for the second quarter 2021 was $4.3 million, or $0.07 per share, compared to $6.3 million, or $0.11 per share, for the second quarter 2020. As of June 30, 2021, the Company had $129.5 million in cash and cash equivalents.

    Guidance

    Codexis is raising its financial guidance issued on June 17, 2021, as follows:

    • FY 2021 total revenues are expected to be in the range of $98 - $103 million; up from prior guidance of $89 to $93 million
    • FY 2021 product revenues are expected to be in the range of $59 - $63 million; up from prior guidance of $45 to $48 million
    • FY 2021 gross margin on product revenue is expected to be in the range of 65% - 68%; up from prior guidance of a range of 60% - 64%  

    Conference Call and Webcast
    Codexis will hold a conference call and webcast today beginning at 4:30 p.m. ET. A live webcast and slide presentation to accompany the conference call will be available on the Investor section of Company website. The conference call dial-in numbers are 877-705-2976 for domestic callers and 201-689-8798 for international callers, and the passcode is 13721066.

    A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing 877-660-6853 for domestic callers or 201-612-7415 for international callers. Please use the passcode 13721066 to access the recording. A webcast replay will be available on the Investors section of www.codexis.com for 30 days, beginning approximately two hours after the completion of the call.

    About Codexis
    Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® platform to discover and develop novel, high performance enzymes and novel biotherapeutics. Codexis enzymes have applications in the sustainable manufacturing of pharmaceuticals, food, and industrial products; the creation of the next generation of life science tools; and as biologic therapeutics and in gene therapy. The Company’s unique enzymes drive improvements such as reduced energy usage, waste generation and capital utilization, higher yields, higher fidelity diagnostics, and more efficacious therapeutics. Codexis enzymes enable the promise of synthetic biology to improve the health of people and the planet. For more information, visit www.codexis.com.

    Forward-Looking Statements
    To the extent that statements contained in this press release are not descriptions of historical facts regarding Codexis, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, among others: Codexis’ guidance on 2021 total revenues, product revenues and gross margin; prospects for product revenue growth in Codexis’ Sustainable Manufacturing business; Codexis’ expectations regarding record annual sales for a single proprietary Codexis enzyme; prospects for Codexis’ self-funded programs and Life Science Tools business and growth in its project pipeline and the anticipated initiation of a first clinical trial of CDX-7108. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Codexis’ control and that could materially affect actual results. Factors that could materially affect actual results include, among others: Codexis’ dependence on its licensees and collaborators; Codexis’ dependence on a limited number of products and customers and potential adverse effects to Codexis’ business if its customers’ products are not received well in the markets. Additional information about factors that could materially affect actual results can be found in Codexis’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 1, 2021, and in Codexis’ Quarterly Report on Form 10-Q filed with the SEC on May 7, 2021, including under the caption “Risk Factors,” and in Codexis’ other periodic reports filed with the SEC. Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

    Investor Relations Contact:
    Argot Partners
    Stephanie Marks/Carrie McKim
    (212) 600-1902
    Codexis@argotpartners.com

    Financial Tables to Follow


    Codexis, Inc.
    Condensed Consolidated Statements of Operations
    (Unaudited)
    (In Thousands, Except Per Share Amounts)

     Three Months Ended June 30, Six Months Ended June 30,
     2021 2020 2021 2020
    Revenues:       
    Product revenue$14,717   $4,504   $24,943   $9,604  
    Research and development revenue10,736   10,463   18,542   20,033  
    Total revenues25,453   14,967   43,485   29,637  
    Costs and operating expenses:       
    Cost of product revenue4,318   1,699   8,536   4,240  
    Research and development12,826   10,853   24,397   21,820  
    Selling, general and administrative12,795   8,522   24,193   17,512  
    Total costs and operating expenses29,939   21,074   57,126   43,572  
    Loss from operations(4,486)  (6,107)  (13,641)  (13,935) 
    Interest income206   57   382   323  
    Other income (expense), net23   13   (63)  (72) 
    Loss before income taxes(4,257)  (6,037)  (13,322)  (13,684) 
    Provision for income taxes8   307   11   312  
    Net loss$(4,265)  $(6,344)  $(13,333)  $(13,996) 
            
    Net loss per share, basic and diluted$(0.07)  $(0.11)  $(0.21)  $(0.24) 
            
    Weighted average common stock shares used in computing net loss per share, basic and diluted64,434   59,000   64,363   58,944  
            

    Codexis, Inc.
    Condensed Consolidated Balance Sheets
    (Unaudited)
    (In Thousands)

     June 30, 2021 December 31, 2020
    Assets   
    Current assets:   
    Cash and cash equivalents$129,506   $149,117  
    Restricted cash, current585   638  
    Investment in non-marketable debt security1,289   1,000  
    Financial assets:   
    Accounts receivable19,488   13,894  
    Contract assets4,528   4,526  
    Unbilled receivables12,417   10,942  
    Total financial assets36,433   29,362  
    Less: allowances(74)  (74) 
    Total financial assets, net36,359   29,288  
    Inventories1,078   964  
    Prepaid expenses and other current assets3,578   3,416  
    Total current assets172,395   184,423  
    Restricted cash1,519   1,062  
    Investment in non-marketable equity securities3,430   1,450  
    Right-of-use assets - Operating leases, net20,124   21,382  
    Right-of-use assets - Finance leases, net68   119  
    Property and equipment, net11,232   9,675  
    Goodwill3,241   3,241  
    Other non-current assets301   294  
    Total assets$212,310   $221,646  
        
    Liabilities and Stockholders' Equity   
    Current liabilities:   
    Accounts payable$3,164   $2,970  
    Accrued compensation6,859   7,288  
    Other accrued liabilities9,082   10,272  
    Current portion of lease obligations - Operating leases2,672   2,627  
    Deferred revenue2,313   1,824  
    Total current liabilities24,090   24,981  
    Deferred revenue, net of current portion3,166   2,967  
    Long-term lease obligations - Operating leases20,992   22,324  
    Other long-term liabilities1,289   1,271  
    Total liabilities49,537   51,543  
        
    Stockholders' equity:   
    Common stock6   6  
    Additional paid-in capital542,519   536,516  
    Accumulated deficit(379,752)  (366,419) 
    Total stockholders' equity162,773   170,103  
    Total liabilities and stockholders' equity$212,310   $221,646  
        

    Codexis, Inc.
    Segmented Information
    (Unaudited)
    (In Thousands)

     Three months ended June 30, 2021 Three months ended June 30, 2020
     Performance Enzymes Novel Biotherapeutics Total Performance Enzymes Novel Biotherapeutics Total
    Revenues:           
    Product revenue$14,717  $—   $14,717   $4,504   $—  $4,504  
    Research and development revenue6,868  3,868   10,736   3,002   7,461  10,463  
    Total revenues21,585  3,868   25,453   7,506   7,461  14,967  
    Costs and operating expenses:           
    Cost of product revenue4,318  —   4,318   1,699   —  1,699  
    Research and development (1)5,057  7,194   12,251   4,997   5,490  10,487  
    Selling, general and administrative(1)3,170  620   3,790   2,375   621  2,996  
    Total segment costs and operating expenses12,545  7,814   20,359   9,071   6,111  15,182  
    Income (loss) from operations$9,040  $(3,946)  5,094   $(1,565)  $1,350  (215) 
    Corporate costs (2)    (8,610)      (5,316) 
    Unallocated depreciation and amortization    (741)      (506) 
    Loss before income taxes    $(4,257)      $(6,037) 
                

    (1) Research and development expenses and selling, general and administrative expenses exclude depreciation and amortization of finance leases.
    (2) Corporate costs include unallocated selling, general and administrative expense, interest income, and other income (expense), net.


     Six months ended June 30, 2021 Six months ended June 30, 2020
     Performance Enzymes Novel Biotherapeutics Total Performance Enzymes Novel Biotherapeutics Total
    Revenues:           
    Product revenue$24,943  $—   $24,943   $9,604   $—   $9,604  
    Research and development revenue10,872  7,670   18,542   8,775   11,258   20,033  
    Total revenues35,815  7,670   43,485   18,379   11,258   29,637  
    Costs and operating expenses:           
    Cost of product revenue8,536  —   8,536   4,240   —   4,240  
    Research and development (1)11,502  11,799   23,301   10,693   10,415   21,108  
    Selling, general and administrative(1)5,988  1,221   7,209   4,720   1,213   5,933  
    Total segment costs and operating expenses26,026  13,020   39,046   19,653   11,628   31,281  
    Income (loss) from operations$9,789  $(5,350)  4,439   $(1,274)  $(370)  (1,644) 
    Corporate costs (2)    (16,335)      (11,042) 
    Unallocated depreciation and amortization    (1,426)      (998) 
    Loss before income taxes    $(13,322)      $(13,684) 
                

    (1) Research and development expenses and selling, general and administrative expenses exclude depreciation and amortization of finance leases.
    (2) Corporate costs include unallocated selling, general and administrative expense, interest income, and other income (expense), net.


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