Anticipate 2024 Product Revenue Growth of at Least 10% vs. 2023 Excluding Enzyme Sales Related to PAXLOVID™
Recently Announced Debt Financing Reinforces Strong Financial Position with Projected Runway Through Expected Positive Cash-flow Around End of 2026
2024 to Focus on Securing Early Access Customers for ECO Synthesis™ Manufacturing Platform, Launch of Double-stranded RNA Ligase and Return to Growth for Pharmaceutical Manufacturing
“We are thrilled with how we closed out 2023, and it’s quite clear that the strategic decisions we made last year are translating into real momentum as we kick off 2024. We recently executed asset purchases for our lead biotherapeutics asset, CDX-7108, with Nestlé Health Science, and our newly engineered dsDNA ligase with Roche. We also completed an out-licensing deal with
Fourth Quarter and Recent Business Highlights
- In
November 2023 at the TIDES Europe annual meeting,Codexis presented a technical update for its Enzyme-Catalyzed Oligonucleotide (ECO) Synthesis™ manufacturing platform, which is in development to enable the commercial-scale production of ribonucleic acid interference (RNAi) therapeutics using an enzymatic route of synthesis. The presentation focused on the Company’s broader enzyme evolution and process development efforts for both the iterative nucleotide addition and the supply of critical nucleotide reagents. Driving for high volumetric productivity, data highlighted multiple, consecutive additions of 2’-modified RNA nucleotides to a growing oligonucleotide sequence, achieving significant coupling efficiencies with immobilized enzymes. Additionally, proof-of-concept was presented for an enzymatic “one-pot, two-step” phosphorylation cascade to manufacture nucleotide reagents for supply with the ECO Synthesis™ manufacturing platform. - In
November 2023 ,Codexis announced the formation of itsStrategic Advisory Board (SAB) to guide the Company’s strategic direction and offer valuable insights to inform the continued development of the ECO Synthesis™ manufacturing platform.John Maraganore , PhD, founder and former Chief Executive Officer of Alnylam Pharmaceuticals, joined theSAB as its inaugural external member. InFebruary 2024 , the Company announced the addition of Masad Damha, PhD, andJim Lalonde , PhD, to theSAB . Dr. Damha is the DistinguishedJames McGill Professor atMcGill University and his research has been instrumental in the development of new therapeutic drugs based on RNA targeting and gene editing.Dr. Lalonde is a consultant focused on enzyme engineering and biotechnology companies and the former Senior Vice President of Research and Development atCodexis , where he oversaw the development of more than 50 enzymes for biotherapeutics, drug manufacturing, nutrition and molecular diagnostics applications. - In
December 2023 ,David Butler , PhD, Chief Technology Officer atHongene Biotech Corporation , joinedDr. Maraganore andCodexis leadership for a virtual key opinion leader event focused on the ECO Synthesis™ technology platform. Drs. Maraganore and Butler discussed the growth of RNAi therapeutics as a modality, the manufacturing landscape and the potential role of an enzymatic route of synthesis to enable the commercial-scale production of these therapeutics. A replay of the virtual event is accessible on the Investor Relations section of the Company’s website, located here. - In
December 2023 ,Codexis achieved gram-scale synthesis with its ECO Synthesis™ technology platform, demonstrating the preparative-scale manufacture of an oligonucleotide, composed of the modified nucleotide building blocks typically used in ribonucleic acid (RNA) therapeutics, under process-like conditions. Successful completion of this technical milestone enablesCodexis engineers to initiate a comprehensive assessment of the purity profile for small interference RNA (siRNA) developed with the ECO Synthesis™ manufacturing platform. Separately, data collected on process-related parameters provides foundational information for early models of the siRNA manufacturing process and allows the Company to open conversations with early access customers on their RNAi therapeutics manufacturing processes. - In
December 2023 , the Company entered into an agreement withAldevron , a global leader in the custom development and manufacture of plasmid DNA, RNA and proteins for the biotech industry, for the global exclusive license to Codexis’ Codex® HiCap RNA Polymerase. Under the terms of the deal,Aldevron will receive global manufacturing and commercialization rights to the Codex® HiCap RNA Polymerase andCodexis will receive payments for near-term technical milestones, along with commercial milestones and sales-based royalties. - In
December 2023 ,Codexis and Nestlé Health Science entered into a purchase agreement for CDX-7108, an investigational therapy for the potential treatment of exocrine pancreatic insufficiency (EPI). Under the terms of the agreement,Codexis will receive up to$45 million in potential milestone payments, including a$5 million upfront payment received inJanuary 2024 , as well as high single-digit net-sales-based royalties.Codexis will receive up to an additional$5 million if Nestlé Health Science exercises an option to purchase two additional early-stage enzymes being developed for EPI. - 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 buffer 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 with Roche for Codexis’ newly engineered dsDNA ligase. Under the terms of the agreement,Codexis is eligible to receive upfront and technical milestone payments. This deal supersedes the prior exclusive license on the evolved T4 DNA ligase.
Upcoming Milestones
Codexis plans to present a technical update on the ECO Synthesis™ manufacturing platform at theTIDES USA annual meeting inMay 2024 . During the event, the Company expects to highlight ECO Synthesis™ platform data demonstrating the linear synthesis of a full-length oligonucleotide strand composed of modified nucleotides and representative of double-stranded siRNA therapeutics.
- Early access customer testing of the ECO Synthesis™ manufacturing platform remains on track to initiate in the second half of 2024. Feedback from this program will provide valuable insights and could lead to initial commercial licensing opportunities in 2025, ahead of an anticipated full commercial launch of the platform in 2026.
- The Company anticipates making its newly engineered, double-stranded RNA (dsRNA) ligase, or ecoRNA™ ligase, program widely available for customers in the second half of 2024. As part of Codexis’ initial market entry into the RNAi therapeutics space, the ecoRNA™ 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 facilities, the ecoRNA™ ligase program provides an opportunity to educate potential customers on the benefits of incorporating enzymatic solutions as a complement to their current manufacturing processes.
Fiscal Year 2023 Financial Highlights
- Total revenues, excluding enzyme sales related to PAXLOVID™, decreased by 2% to
$62.0 million for fiscal year 2023 compared to$63.2 million for fiscal year 2022. Including enzyme sales related to PAXLOVID™, total revenues were$70.1 million for fiscal year 2023 compared to$138.6 million for fiscal year 2022. - Product revenues, excluding enzyme sales related to PAXLOVID™, decreased by 16% to
$34.8 million for fiscal year 2023 compared to$41.3 million for fiscal year 2022. Including enzyme sales related to PAXLOVID™, product revenues were$42.9 million for fiscal year 2023 compared to$116.7 million for fiscal year 2022. - R&D revenues for fiscal year 2023 were
$27.2 million compared to$21.9 million for fiscal year 2022; the increase was primarily due to higher license fees from Pfizer and Nestlé, offset by lower R&D fees from existing collaboration agreements. - Product gross margin, excluding enzyme sales related to PAXLOVID™, was 63% for fiscal year 2023 compared to 52% for fiscal year 2022. The increase was largely due to deferred product revenue with no related costs in 2023 that was recognized due to the planned termination of an enzyme supply agreement with a food and feed customer, partially offset by variability in the product mix. Including enzyme sales related to PAXLOVID™, product gross margin for fiscal year 2023 was 70% compared to 67% for fiscal year 2022.
- R&D expenses for fiscal year 2023 were
$58.9 million compared to$80.1 million for fiscal year 2022; the decrease was primarily driven by a decrease in costs associated with lower headcount, a decrease in outside services related to manufacturing and regulatory expense, lower lab supplies expense, and a decrease in lease costs due to assignment of theSan Carlos facility lease. - Selling, General & Administrative expenses for fiscal year 2023 were
$53.3 million compared to$52.2 million for fiscal year 2022; the increase was primarily due to higher payroll-based expenses and higher fees for outside services, partially offset by lower stock-based compensation costs. - The net loss for fiscal year 2023 was
$76.2 million , or$1.12 per share, compared to a net loss of$33.6 million , or$0.51 per share, for the fiscal year 2022. Excluding enzyme sales related to PAXLOVID™, net loss for the fiscal year 2023 would have been$84.4 million , or$1.24 per share. Further excluding all charges related to the restructuring and non-cash impairment charges, net loss for fiscal year 2023 was$50.8 million , or$0.74 per share. - As of
December 31, 2023 , the Company had pro forma cash and cash equivalents of$70.1 million , including cash and cash equivalents of approximately$65.1 million as ofDecember 31, 2023 , and a$5.0 million upfront payment received inJanuary 2024 related to the recent Nestlé transaction. In addition, the Company retained approximately$29.2 million in net proceeds from a previously announced debt financing inFebruary 2024 .
Fourth Quarter 2023 Financial Highlights
- Total revenues, excluding enzyme sales related to PAXLOVID™, increased by 42% to
$18.4 million for fourth quarter 2023 compared to$13.0 million in fourth quarter 2022. Including enzyme sales related to PAXLOVID™, total revenues were$26.6 million in fourth quarter 2023 compared to$30.4 million in fourth quarter 2022. - Product revenues, excluding enzyme sales related to PAXLOVID™, increased by 69% to
$9.9 million for fourth quarter 2023 compared to$5.9 million in fourth quarter 2022. Including enzyme sales related to PAXLOVID™, product revenues were$18.1 million in fourth quarter 2023 compared to$23.3 million in fourth quarter 2022. - R&D revenues for fourth quarter 2023 were
$8.5 million compared to$7.1 million in fourth quarter 2022; the increase was primarily due to higher license fees, offset by lower R&D fees from existing collaboration agreements. - Product gross margin, excluding enzyme sales related to PAXLOVID™, was 71% for fourth quarter 2023 compared to 44% in fourth quarter 2022. The increase was largely due to increased sales of higher margin products. Including enzyme sales related to PAXLOVID™, product gross margin for fourth quarter 2023 was 84% compared to 64% in fourth quarter 2022.
- R&D expenses for fourth quarter 2023 were
$11.2 million compared to$19.7 million in fourth quarter 2022; the decrease was primarily driven by a decrease in costs associated with lower headcount, a decrease in outside services related to manufacturing and regulatory expenses and lower lab supply. - Selling, General & Administrative expenses for fourth quarter 2023 were
$12.2 million compared to$12.3 million in fourth quarter 2022; the decrease was primarily due to lower payroll-based expenses and stock-based compensation costs. - The net loss for fourth quarter 2023 was
$7.2 million , or$0.10 per share, compared to a net loss of$12.6 million , or$0.19 per share, for fourth quarter 2022. Excluding enzyme sales related to PAXLOVID™, net loss for fourth quarter 2023 would have been$15.3 million , or$0.22 per share.
- Excluding all non-cash impairment charges, net income for fourth quarter 2023 was
$1.1 million , or$0.02 per share.
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™.
- In addition,
Codexis expects that its existing cash and cash equivalents will be sufficient to fund its planned operations through positive cash flow, expected around the end of 2026.
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
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Condensed Consolidated Statements of Operations
(unaudited)
(In Thousands, Except Per Share Amounts)
Three Months Ended | Year Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenues: | |||||||||||||||
Product revenue | $ | 18,099 | $ | 23,300 | $ | 42,906 | $ | 116,676 | |||||||
Research and development revenue | 8,462 | 7,075 | 27,237 | 21,914 | |||||||||||
Total revenues | 26,561 | 30,375 | 70,143 | 138,590 | |||||||||||
Costs and operating expenses: | |||||||||||||||
Cost of product revenue | 2,861 | 8,456 | 12,809 | 38,033 | |||||||||||
Research and development | 11,234 | 19,689 | 58,885 | 80,099 | |||||||||||
Selling, general and administrative | 12,184 | 12,314 | 53,250 | 52,172 | |||||||||||
Restructuring charges | — | 3,167 | 3,284 | 3,167 | |||||||||||
Asset impairment and other charges | — | — | 9,984 | — | |||||||||||
Total costs and operating expenses | 26,279 | 43,626 | 138,212 | 173,471 | |||||||||||
Loss from operations | 282 | (13,251 | ) | (68,069 | ) | (34,881 | ) | ||||||||
Interest income | 906 | 823 | 4,172 | 1,441 | |||||||||||
Other income (expense), net | (8,345 | ) | (26 | ) | (12,274 | ) | 124 | ||||||||
Loss before income taxes | (7,157 | ) | (12,454 | ) | (76,171 | ) | (33,316 | ) | |||||||
Provision for income taxes | 35 | 151 | 69 | 276 | |||||||||||
Net loss | $ | (7,192 | ) | $ | (12,605 | ) | $ | (76,240 | ) | $ | (33,592 | ) | |||
Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.19 | ) | $ | (1.12 | ) | $ | (0.51 | ) | |||
Weighted average common stock shares used in computing net loss per share, basic and diluted | 69,500 | 65,558 | 68,131 | 65,344 | |||||||||||
Condensed Consolidated Balance Sheets
(unaudited)
(In Thousands)
2023 | 2022 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 65,116 | $ | 113,984 | |||
Restricted cash, current | 519 | 521 | |||||
Financial assets: | |||||||
Accounts receivable | 10,036 | 31,904 | |||||
Contract assets | 815 | 2,116 | |||||
Unbilled receivables | 9,142 | 7,016 | |||||
Total financial assets | 19,993 | 41,036 | |||||
Less: allowances | (65 | ) | (163 | ) | |||
Total financial assets, net | 19,928 | 40,873 | |||||
Inventories | 2,685 | 2,029 | |||||
Prepaid expenses and other current assets | 5,218 | 5,487 | |||||
Total current assets | 93,466 | 162,894 | |||||
Restricted cash | 1,062 | 1,521 | |||||
Investment in non-marketable equity securities | 9,700 | 20,510 | |||||
Right-of-use assets - Operating leases, net | 13,137 | 39,263 | |||||
Property and equipment, net | 15,487 | 22,614 | |||||
2,463 | 3,241 | ||||||
Other non-current assets | 1,246 | 350 | |||||
Total assets | $ | 136,561 | $ | 250,393 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 5,947 | $ | 3,246 | |||
Accrued compensation | 11,246 | 11,453 | |||||
Other accrued liabilities | 4,735 | 15,279 | |||||
Current portion of lease obligations - Operating leases | 3,781 | 5,360 | |||||
Deferred revenue | 10,121 | 13,728 | |||||
Total current liabilities | 35,830 | 49,066 | |||||
Deferred revenue, net of current portion | 640 | 16,881 | |||||
Long-term lease obligations - Operating leases | 12,243 | 38,278 | |||||
Other long-term liabilities | 1,233 | 1,371 | |||||
Total liabilities | 49,946 | 105,596 | |||||
Stockholders’ equity: | |||||||
Common stock | 7 | 6 | |||||
Additional paid-in capital | 584,138 | 566,081 | |||||
Accumulated deficit | (497,530 | ) | (421,290 | ) | |||
Total stockholders’ equity | 86,615 | 144,797 | |||||
Total liabilities and stockholders’ equity | $ | 136,561 | $ | 250,393 | |||
Source:
2024 GlobeNewswire, Inc., source