EX-99.1
Published on August 5, 2021
Exhibit 99.1
五星体育直播 Reports Second Quarter 2021 Financial Results
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., August 5, 2021 鈥� 五星体育直播 (Nasdaq:CDXS), a leading enzyme engineering company enabling the promise of synthetic biology, today announced financial results for the second quarter ended June听30, 2021 and provided a business update.
鈥溛逍翘逵辈� had an extraordinarily strong second quarter, with record product revenue that also drove our product gross margin to a new high,鈥� said John Nicols, 五星体育直播 President and CEO. 鈥淥ur Sustainable Manufacturing business showcased 五星体育直播鈥� 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 五星体育直播鈥� proprietary enzymes for delivery in the second half of 2021, which should culminate in the largest annual sales for a product in the Company鈥檚 history. In the second quarter, another facet of 五星体育直播鈥� business model was highlighted by the receipt of a CodeEvolver庐 platform milestone payment from GlaxoSmithKline (GSK), our largest-ever backend license payment.
鈥淥ur 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 五星体育直播鈥� 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 五星体育直播, 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,鈥� concluded Mr. Nicols.
Key Performance Indicators and Recent Business Highlights
鈥�Product revenues increased 227% to $14.7 million in Q2鈥�21, primarily driven by the sale of enzymes used to manufacture branded pharmaceutical products.
鈥�Product gross margin climbed to 71% in Q2鈥�21, driven by a shift in the sales mix to higher margin products.
鈥�In the second quarter, 五星体育直播 had 22 customers who contributed over $100,000 in revenue, nine of which contributed over $1 million in revenue.
鈥�In the Sustainable Manufacturing business, 五星体育直播 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庐 platform licensing milestone payment from GSK, related to the advancement of the commercialization of an enzyme, engineered by GSK, using CodeEvolver庐 to improve a key step in the manufacturing process for a currently undisclosed drug. In July, 五星体育直播 announced the completion of the technology transfer to Novartis Pharma AG for a non-exclusive license to the CodeEvolver庐 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.
鈥�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庐 HiFi DNA polymerase and Codex庐 HiCap RNA polymerase remains strong. 五星体育直播 continues to drive both partnered and self-funded research and product development, notably making significant technical progress in its enzymatic DNA synthesis
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collaboration with Molecular Assemblies, which is on track for the enzyme engineering to be completed in the second half of 2021.
鈥�In the Biotherapeutics segment, 五星体育直播鈥� 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 Nestl茅 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
五星体育直播 published its annual pipeline snapshot as of June 30, 2021, which is available on the Presentations page of the Company鈥檚 investor relations website. Highlights include:
鈥�Total Number of Programs: The total number of commercial products and pipeline programs as of June听30, 2021 increased to 78 from 65 a year ago.
鈥�Commercial Products by Market: 五星体育直播 had 17 commercial products as of June听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).
鈥�Pre-Commercial Products by Market: The Company had 61 pre-commercial programs as of June听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).
鈥�Partnered vs Self-Funded Programs: As of June听30, 2021, 45 of 五星体育直播鈥� pre-commercial programs were partnered (up from 38 a year ago) and 16 were self-funded (up from 13).
Second Quarter 2021 Financial Highlights
鈥�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.
鈥�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.
鈥�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.
鈥�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.
鈥�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
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五星体育直播 is raising its financial guidance issued on June 17, 2021, as follows:
鈥�FY 2021 total revenues are expected to be in the range of $98 - $103 million; up from prior guidance of $89 to $93 million
鈥�FY 2021 product revenues are expected to be in the range of $59 - $63 million; up from prior guidance of $45 to $48 million
鈥�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
五星体育直播 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 五星体育直播
五星体育直播 is a leading enzyme engineering company leveraging its proprietary CodeEvolver庐 platform to discover and develop novel, high performance enzymes and novel biotherapeutics. 五星体育直播 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鈥檚 unique enzymes drive improvements such as reduced energy usage, waste generation and capital utilization, higher yields, higher fidelity diagnostics, and more efficacious therapeutics. 五星体育直播 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 五星体育直播, 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: 五星体育直播鈥� guidance on 2021 total revenues, product revenues and gross margin; prospects for product revenue growth in 五星体育直播鈥� Sustainable Manufacturing business; 五星体育直播鈥� expectations regarding record annual sales for a single proprietary 五星体育直播 enzyme; prospects for 五星体育直播鈥� 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 五星体育直播鈥� control and that could materially affect actual results. Factors that could materially affect actual results include, among others: 五星体育直播鈥� dependence on its licensees and collaborators; 五星体育直播鈥� dependence on a limited number of products and customers and potential adverse effects to 五星体育直播鈥� business if its customers鈥� products are not received well in the markets. Additional information about factors that could materially affect actual results can be found in 五星体育直播鈥� Annual Report on Form 10-K filed with the Securities and Exchange Commission (鈥淪EC鈥�) on March 1, 2021, and in 五星体育直播鈥� Quarterly Report on Form 10-Q filed with the SEC on May 7, 2021, including under the caption 鈥淩isk Factors,鈥� and in 五星体育直播鈥� other periodic reports filed with the SEC. 五星体育直播 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
五星体育直播@argotpartners.com
Financial Tables to Follow
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五星体育直播
Condensed Consolidated Statements of Operations
(Unaudited)
(In Thousands, Except Per Share Amounts)
| 听 | Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||||
| 听 | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| Product revenue | $ | 14,717听 | $ | 4,504听 | $ | 24,943听 | $ | 9,604听 | |||||||||||||||
| Research and development revenue | 10,736听 | 10,463听 | 18,542听 | 20,033听 | |||||||||||||||||||
| Total revenues | 25,453听 | 14,967听 | 43,485听 | 29,637听 | |||||||||||||||||||
| Costs and operating expenses: | |||||||||||||||||||||||
| Cost of product revenue | 4,318听 | 1,699听 | 8,536听 | 4,240听 | |||||||||||||||||||
| Research and development | 12,826听 | 10,853听 | 24,397听 | 21,820听 | |||||||||||||||||||
| Selling, general and administrative | 12,795听 | 8,522听 | 24,193听 | 17,512听 | |||||||||||||||||||
| Total costs and operating expenses | 29,939听 | 21,074听 | 57,126听 | 43,572听 | |||||||||||||||||||
| Loss from operations | (4,486) | (6,107) | (13,641) | (13,935) | |||||||||||||||||||
| Interest income | 206听 | 57听 | 382听 | 323听 | |||||||||||||||||||
| Other income (expense), net | 23听 | 13听 | (63) | (72) | |||||||||||||||||||
| Loss before income taxes | (4,257) | (6,037) | (13,322) | (13,684) | |||||||||||||||||||
| Provision for income taxes | 8听 | 307听 | 11听 | 312听 | |||||||||||||||||||
| 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 diluted | 64,434听 | 59,000听 | 64,363听 | 58,944听 | |||||||||||||||||||
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五星体育直播
Condensed Consolidated Balance Sheets
(Unaudited)
(In Thousands)
| June 30, 2021 | December 31, 2020 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 129,506听 | $ | 149,117听 | |||||||
| Restricted cash, current | 585听 | 638听 | |||||||||
| Investment in non-marketable debt security | 1,289听 | 1,000听 | |||||||||
| Financial assets: | |||||||||||
| 听听听听听Accounts receivable | 19,488听 | 13,894听 | |||||||||
| 听听听听听Contract assets | 4,528听 | 4,526听 | |||||||||
| Unbilled receivables | 12,417听 | 10,942听 | |||||||||
| 听听听听听听听听Total financial assets | 36,433听 | 29,362听 | |||||||||
| 听听听听听听听听听听听听听Less: allowances | (74) | (74) | |||||||||
| 听听听听听听听听听Total financial assets, net | 36,359听 | 29,288听 | |||||||||
| Inventories | 1,078听 | 964听 | |||||||||
| Prepaid expenses and other current assets | 3,578听 | 3,416听 | |||||||||
| Total current assets | 172,395听 | 184,423听 | |||||||||
| Restricted cash | 1,519听 | 1,062听 | |||||||||
| Investment in non-marketable equity securities | 3,430听 | 1,450听 | |||||||||
| Right-of-use assets - Operating leases, net | 20,124听 | 21,382听 | |||||||||
| Right-of-use assets - Finance leases, net | 68听 | 119听 | |||||||||
| Property and equipment, net | 11,232听 | 9,675听 | |||||||||
| Goodwill | 3,241听 | 3,241听 | |||||||||
| Other non-current assets | 301听 | 294听 | |||||||||
| Total assets | $ | 212,310听 | $ | 221,646听 | |||||||
| Liabilities and Stockholders' Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 3,164听 | $ | 2,970听 | |||||||
| Accrued compensation | 6,859听 | 7,288听 | |||||||||
| Other accrued liabilities | 9,082听 | 10,272听 | |||||||||
| Current portion of lease obligations - Operating leases | 2,672听 | 2,627听 | |||||||||
| Deferred revenue | 2,313听 | 1,824听 | |||||||||
| Total current liabilities | 24,090听 | 24,981听 | |||||||||
| Deferred revenue, net of current portion | 3,166听 | 2,967听 | |||||||||
| Long-term lease obligations - Operating leases | 20,992听 | 22,324听 | |||||||||
| Other long-term liabilities | 1,289听 | 1,271听 | |||||||||
| Total liabilities | 49,537听 | 51,543听 | |||||||||
| Stockholders' equity: | |||||||||||
| Common stock | 6听 | 6听 | |||||||||
| Additional paid-in capital | 542,519听 | 536,516听 | |||||||||
| Accumulated deficit | (379,752) | (366,419) | |||||||||
| Total stockholders' equity | 162,773听 | 170,103听 | |||||||||
| Total liabilities and stockholders' equity | $ | 212,310听 | $ | 221,646听 | |||||||
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五星体育直播
Segmented Information
(Unaudited)
(In Thousands)
| 听 | Three months ended June 30, 2021 | Three months ended June 30, 2020 | |||||||||||||||||||||||||||||||||
| 听 | Performance Enzymes | Novel Biotherapeutics | Total | Performance Enzymes | Novel Biotherapeutics | Total | |||||||||||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||||||||||||||
| Product revenue | $ | 14,717听 | $ | 鈥斕� | $ | 14,717听 | $ | 4,504听 | $ | 鈥斕� | $ | 4,504听 | |||||||||||||||||||||||
| Research and development revenue | 6,868听 | 3,868听 | 10,736听 | 3,002听 | 7,461听 | 10,463听 | |||||||||||||||||||||||||||||
| Total revenues | 21,585听 | 3,868听 | 25,453听 | 7,506听 | 7,461听 | 14,967听 | |||||||||||||||||||||||||||||
| Costs and operating expenses: | |||||||||||||||||||||||||||||||||||
| Cost of product revenue | 4,318听 | 鈥斕� | 4,318听 | 1,699听 | 鈥斕� | 1,699听 | |||||||||||||||||||||||||||||
Research and development (1)
|
5,057听 | 7,194听 | 12,251听 | 4,997听 | 5,490听 | 10,487听 | |||||||||||||||||||||||||||||
Selling, general and administrative(1)
|
3,170听 | 620听 | 3,790听 | 2,375听 | 621听 | 2,996听 | |||||||||||||||||||||||||||||
| Total segment costs and operating expenses | 12,545听 | 7,814听 | 20,359听 | 9,071听 | 6,111听 | 15,182听 | |||||||||||||||||||||||||||||
| Income (loss) from operations | $ | 9,040听 | $ | (3,946) | 5,094听 | $ | (1,565) | $ | 1,350听 | (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.
| 听 | Six months ended June 30, 2021 | Six months ended June 30, 2020 | |||||||||||||||||||||||||||||||||
| 听 | Performance Enzymes | Novel Biotherapeutics | Total | Performance Enzymes | Novel Biotherapeutics | Total | |||||||||||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||||||||||||||
| Product revenue | $ | 24,943听 | $ | 鈥斕� | $ | 24,943听 | $ | 9,604听 | $ | 鈥斕� | $ | 9,604听 | |||||||||||||||||||||||
| Research and development revenue | 10,872听 | 7,670听 | 18,542听 | 8,775听 | 11,258听 | 20,033听 | |||||||||||||||||||||||||||||
| Total revenues | 35,815听 | 7,670听 | 43,485听 | 18,379听 | 11,258听 | 29,637听 | |||||||||||||||||||||||||||||
| Costs and operating expenses: | |||||||||||||||||||||||||||||||||||
| Cost of product revenue | 8,536听 | 鈥斕� | 8,536听 | 4,240听 | 鈥斕� | 4,240听 | |||||||||||||||||||||||||||||
Research and development (1)
|
11,502听 | 11,799听 | 23,301听 | 10,693听 | 10,415听 | 21,108听 | |||||||||||||||||||||||||||||
Selling, general and administrative(1)
|
5,988听 | 1,221听 | 7,209听 | 4,720听 | 1,213听 | 5,933听 | |||||||||||||||||||||||||||||
| Total segment costs and operating expenses | 26,026听 | 13,020听 | 39,046听 | 19,653听 | 11,628听 | 31,281听 | |||||||||||||||||||||||||||||
| Income (loss) from operations | $ | 9,789听 | $ | (5,350) | 4,439听 | $ | (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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