Q1 Total Revenue Up 32% Year-over-year, Including Product Revenue Up 14%; Company Reiterates 2024 Financial Guidance
First Substantial Order for dsRNA Ligase Received from Large Pharma Customer
Company is in Final Stages of Enzymatically Synthesizing a Full-Length Oligonucleotide with ECO Synthesis™ Manufacturing Platform and will Provide Update at
“We are off to a strong start this year with our first quarter financial results, and we are on track to deliver full year product revenue growth of at least ten percent. We have also added flexibility to our projected cash runway through our debt financing deal with
First Quarter and Recent Business Highlights
- In
March 2024 , the Company received a low-to-mid-single-digit million-dollar order for its double-stranded RNA (dsRNA) ligase from a top tier pharmaceutical company. This significant transaction reinforces the increasing need from customers to enzymatically join separate RNA fragments via a ligation step. - In
February 2024 ,Codexis announced it had entered into a loan facility agreement with an affiliate ofInnovatus Capital Partners, LLC , for up to$40 million . The non-dilutive capital reinforces the strength of Codexis’ cash position, provides additional flexibility on the Company’s projected cash runway and enables the accelerated development of certain elements of the ECO Synthesis™ manufacturing platform, including the planned build-out of an ECO Synthesis™Innovation Lab . - In
February 2024 , the Company announced it had entered into an exclusive, global license agreement withRoche Sequencing Solutions, Inc. for Codexis’ newly engineered dsDNA ligase. Under the terms of the agreement,Codexis is eligible to receive a total of mid-single digit million dollars in upfront and technical milestone payments. - In
April 2024 ,Codexis completed an asset purchase agreement to sell its Homocystinuria (HCU) and Maple Syrup Urine Disease (MSUD) compounds.Codexis is eligible to receive development milestone payments and future royalties on net sales. - Three leading experts in oligonucleotide research, development and commercialization have joined Codexis’
Strategic Advisory Board (SAB) since the first of the year. Masad Damha, PhD, DistinguishedJames McGill Professor atMcGill University ;Jim Lalonde , PhD, biotechnology consultant for start-up companies in enzyme engineering and former Senior Vice President of Research and Development atCodexis ; andCarole Cobb , MBA, biotechnology consultant and former Chief Operating Officer at GreenLight Biosciences, will collaborate with inaugural external memberJohn Maraganore , PhD, Founder and Former Chief Executive Officer at Alnylam Pharmaceuticals. TheSAB held its first meeting at the end of April.
Upcoming Milestones
Codexis is finalizing the enzymatic synthesis of a full-length oligonucleotide with its ECO Synthesis™ manufacturing platform, which it expects to complete and present at theTIDES USA annual meeting being heldMay 14-17, 2024 , inBoston .
- The Company continues to build upon its capability in dsRNA ligation with the launch of its ligase screening service at the
TIDES USA meeting and the anticipated launch of its ligase kits in the second half of 2024. As part of Codexis’ initial market entry into the RNAi therapeutics space, the dsRNA ligase program is designed to augment and improve traditional phosphoramidite chemistry by stitching together small, manufactured strands of RNA. In addition to enabling the more efficient use of existing chemical synthesis with the potential to reduce overall costs, the dsRNA ligase provides an opportunity to educate potential customers on the benefits of incorporating enzymatic solutions as a complement to their current manufacturing processes. Codexis expects to substantially complete the build-out of its ECO Synthesis™Innovation Lab by the end of 2024. In addition to providing a strong basis for partnering discussions and early access customer shared development programs, this facility will enableCodexis to demonstrate its RNA ligation capabilities and test new nucleotide modifications and conjugation modalities; develop tech transfer protocols and ensure flexibility with a small-scale footprint; and allow the Company to model scalability into full-scale GMP manufacturing.- Early access customer testing of the full ECO Synthesis™ manufacturing platform remains on track to begin in the second half of 2024. Customer feedback will provide valuable insights and the Company expects it to lead to potential commercial licensing opportunities in the second half of 2025, ahead of an anticipated full commercial launch of the platform in 2026.
First Quarter 2024 Financial Highlights
- Total revenues increased by 32% to
$17.1 million for first quarter 2024 compared to$13.0 million in first quarter 2023. - Product revenues increased by 14% to
$9.6 million for first quarter 2024 compared to$8.4 million in first quarter 2023. - R&D revenues for first quarter 2024 were
$7.5 million compared to$4.6 million in first quarter 2023; the increase was primarily due to the recognition of$6.0 million related to the agreement with Roche for an exclusive, global license for the Company’s newly engineered double-stranded DNA ligase. First quarter 2023 R&D revenues included$3.5 million related to Biotherapeutics programs that the Company previously announced it was discontinuing. - Product gross margin was 49% for first quarter 2024 compared to 46% in first quarter 2023. The improvement in gross margin was largely due to variability in the product mix.
- R&D expenses for first quarter 2024 were
$11.2 million compared to$16.7 million in first quarter 2023; the decrease was primarily driven by a decrease in costs associated with lower headcount, a decrease in outside services related to Chemistry, Manufacturing and Controls and regulatory expenses, a decrease in lease costs due to the assignment of the Company’sSan Carlos facility lease during the fourth quarter of 2023 and lower lab supply costs. - Selling, General & Administrative expenses for first quarter 2024 were
$12.9 million compared to$15.4 million in first quarter 2023; the decrease was primarily due to a decrease in costs associated with lower headcount, a decrease in consulting and outside services and lower marketing and advertising costs, partially offset by higher non-cash stock-based compensation expense.
- The net loss for first quarter 2024 was
$11.5 million , or$0.16 per share, compared to a net loss of$22.6 million , or$0.34 per share, for first quarter 2023.
- As of
March 31, 2024 , the Company had$85.5 million in cash, cash equivalents and investments.Codexis expects its existing cash, cash equivalents and investments will be sufficient to fund its planned operations through positive cash flow, expected around the end of 2026.
2024 Financial Guidance
- Product revenues are expected to be in the range of
$38 million to$42 million , excluding revenue related to PAXLOVID™. - R&D revenues are expected to be in the range of
$18 million to$22 million . - Gross margin on product revenue is expected to be in the range of 58% to 63%, excluding revenue related to PAXLOVID™.
Conference Call and Webcast
A telephone 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 13726635 to access the recording. A webcast replay will be available on the Investors section of the Company website for 90 days, beginning approximately two hours after the completion of the call.
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “suggest,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. To the extent that statements contained in this press release are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management, including but not limited to statements regarding anticipated milestones, including product launches, technical milestones, data releases and public announcements related thereto; whether
For More Information
Investor Contact
(336) 608-9706
ir@codexis.com
Media Contact
(650) 421-8205
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Condensed Consolidated Statements of Operations
(Unaudited)
(In Thousands, Except Per Share Amounts)
Three Months Ended | |||||||
2024 | 2023 | ||||||
Revenues: | |||||||
Product revenue | $ | 9,551 | $ | 8,364 | |||
Research and development revenue | 7,522 | 4,618 | |||||
Total revenues | 17,073 | 12,982 | |||||
Costs and operating expenses: | |||||||
Cost of product revenue | 4,855 | 4,521 | |||||
Research and development | 11,246 | 16,655 | |||||
Selling, general and administrative | 12,860 | 15,399 | |||||
Restructuring charges | — | 72 | |||||
Total costs and operating expenses | 28,961 | 36,647 | |||||
Loss from operations | (11,888 | ) | (23,665 | ) | |||
Interest income | 909 | 1,089 | |||||
Other expense, net | (516 | ) | (25 | ) | |||
Loss before income taxes | (11,495 | ) | (22,601 | ) | |||
Provision for income taxes | 10 | 16 | |||||
Net loss | $ | (11,505 | ) | $ | (22,617 | ) | |
Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (0.34 | ) | |
Weighted average common stock shares used in computing net loss per share, basic and diluted | 69,854 | 65,931 | |||||
Condensed Consolidated Statements of Comprehensive Loss
(Unaudited)
(In Thousands)
Three Months Ended | |||||||
2024 | 2023 | ||||||
Net loss | $ | (11,505 | ) | $ | (22,617 | ) | |
Other comprehensive loss: | |||||||
Unrealized loss on available-for-sale short-term investments, net of tax | (16 | ) | — | ||||
Comprehensive loss | $ | (11,521 | ) | $ | (22,617 | ) | |
Condensed Consolidated Balance Sheets
(Unaudited)
(In Thousands)
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 58,046 | $ | 65,116 | |||
Restricted cash, current | 518 | 519 | |||||
Short-term investments | 27,469 | — | |||||
Financial assets: | |||||||
Accounts receivable | 6,240 | 10,036 | |||||
Contract assets | 2,571 | 815 | |||||
Unbilled receivables | 5,459 | 9,142 | |||||
Total financial assets | 14,270 | 19,993 | |||||
Less: allowances | (65 | ) | (65 | ) | |||
Total financial assets, net | 14,205 | 19,928 | |||||
Inventories | 2,441 | 2,685 | |||||
Prepaid expenses and other current assets | 5,269 | 5,218 | |||||
Total current assets | 107,948 | 93,466 | |||||
Restricted cash | 1,062 | 1,062 | |||||
Investment in non-marketable equity securities | 9,700 | 9,700 | |||||
Right-of-use assets - Operating leases, net | 12,364 | 13,137 | |||||
Property and equipment, net | 14,668 | 15,487 | |||||
2,463 | 2,463 | ||||||
Other non-current assets | 1,354 | 1,246 | |||||
Total assets | $ | 149,559 | $ | 136,561 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,465 | $ | 5,947 | |||
Accrued compensation | 6,502 | 11,246 | |||||
Other accrued liabilities | 5,374 | 4,735 | |||||
Current portion of lease obligations - Operating leases | 3,879 | 3,781 | |||||
Deferred revenue | 9,860 | 10,121 | |||||
Total current liabilities | 29,080 | 35,830 | |||||
Deferred revenue, net of current portion | 630 | 640 | |||||
Long-term lease obligations - Operating leases | 11,232 | 12,243 | |||||
Long-term debt | 28,102 | — | |||||
Other long-term liabilities | 1,248 | 1,233 | |||||
Total liabilities | 70,292 | 49,946 | |||||
Stockholders' equity: | |||||||
Common stock | 7 | 7 | |||||
Additional paid-in capital | 588,311 | 584,138 | |||||
Accumulated other comprehensive income | (16 | ) | — | ||||
Accumulated deficit | (509,035 | ) | (497,530 | ) | |||
Total stockholders' equity | 79,267 | 86,615 | |||||
Total liabilities and stockholders' equity | $ | 149,559 | $ | 136,561 | |||
Source:
2024 GlobeNewswire, Inc., source