五星体育直播

五星体育直播 Reports Fourth Quarter and Fiscal Year 2022 Financial Results

Biotherapeutics Application of CodeEvolver庐 Validated by Recent Data Supporting the Potential for Three Upcoming Investigational New Drug Applications

Cash Runway Through End of 2024 Funds Important Upcoming Milestones

Company Provides 2023 Revenue Guidance

REDWOOD CITY, Calif., Feb. 23, 2023 (GLOBE NEWSWIRE) -- 五星体育直播 (NASDAQ: CDXS), a leading enzyme engineering company, today announced financial results for the fourth quarter and fiscal year ended December 31, 2022 and provided a business update.

鈥�2022 was an important year for 五星体育直播 as we prioritized programs in our life sciences, biotherapeutics, and pharmaceutical manufacturing businesses that align with our focused strategy and best position the Company for long-term success,鈥� said Stephen Dilly, MBBS, PhD, President and CEO of 五星体育直播. 鈥淚n addition to our strong financial performance last year, I am especially pleased with the first patient data set from our study of CDX-7108 for exocrine pancreatic insufficiency in partnership with Nestl茅 Health Science and with the pre-clinical data recently presented by Takeda in Fabry disease, which validates the potential of our CodeEvolver庐 platform in gene therapy. We also continue to make great progress in our life sciences business and recently launched our newly engineered DNA ligase which is designed to improve sensitivity of next generation sequencing testing and easily fit into existing workflows. With two years of cash runway and numerous catalysts ahead, we are well positioned to demonstrate the commercial potential and strategic optionality that exists within 五星体育直播.鈥�

2022 Business Highlights

Corporate Highlights

• In November 2022, 五星体育直播 announced a plan to prioritize time and resources on areas where the Company believes it has the strongest commercial opportunity and greatest probability of success. As part of this plan, the Company decided to discontinue investment in certain internal development programs, expand investment in high potential development programs, and realign its workforce.
  
  
• Throughout 2022 and early 2023, the Company strengthened its management team and Board of Directors with individuals who possess the strategic acumen, operational experience, and commercial mindset to deliver on its prioritized corporate goals. These changes include the addition of Dr. Stephen Dilly as President and CEO, Kevin Norrett as Chief Operating Officer, Sri Ryali as Chief Financial Officer, Meg Fitzgerald, JD, as Chief Legal Officer and General Counsel, and the additions of both H. Stewart Parker and Rahul Singhvi, ScD, to the Board of Directors.

Life Sciences

• In February 2023, at the Advances in Genome Biology and Technology (AGBT) General Meeting, 五星体育直播 launched a newly engineered DNA ligase for next-generation sequencing, or NGS. Subsequently, Roche exercised its right of first negotiation (ROFN) on the newly engineered DNA ligase. For additional details, please see the white paper available at /resources/detail/11503/a-ligase-with-superior-ligation-efficiency.
  
  
• In August 2022, 五星体育直播 and Molecular Assemblies, Inc. (MAI) announced the execution of a Commercial License and Enzyme Supply Agreement, enabling MAI to utilize an evolved terminal deoxynucleotidyl transferase (TdT) enzyme in MAI鈥檚 Fully Enzymatic Synthesis鈩� (or FES鈩�) technology. The companies collaborated to develop this TdT enzyme to advance fully enzymatic DNA synthesis for the production of long, pure, accurate oligonucleotides to accelerate innovation in many fields.
  
  
• In April 2022, 五星体育直播 announced a partnership and strategic investment with seqWell, Inc., a developer of transformative library preparation products for next generation sequencing applications.

Biotherapeutics

• In February 2023, 五星体育直播 announced interim results from the Phase 1 clinical trial of CDX-7108, which is being co-developed with Nestl茅 Health Science S.A., for the treatment of exocrine pancreatic insufficiency (EPI). Data from five subjects with EPI in the proof-of-concept arm indicated improved lipid absorption when patients are administered CDX-7108 versus placebo. Importantly, no safety issues were noted in the 48 healthy subjects that participated in the single ascending dose and multiple ascending dose portion of the study.
  
  
• In February 2023, Takeda Pharmaceutical Company Limited (Takeda) presented pre-clinical data from the Fabry disease transgene program, part of its Strategic Collaboration and License Agreement with 五星体育直播, at the 19th Annual WORLDSymposium鈩�. The gene therapy candidate is being developed to encode the codon optimized, CodeEvolver庐 engineered a-GAL enzyme, which is designed to have improved serum and lysosomal stability and a predicted reduced immunogenicity.

Pharmaceutical Manufacturing

• In September 2022, 五星体育直播 hosted its 2022 Protein Engineering Forum, bringing more than 100 top scientists and innovators together for presentations and networking events to facilitate the sharing of insights and recent technological advancements throughout genomics, nucleic acid synthesis and synthetic biology.
  
  
• In June 2022, Merck and 五星体育直播 published a paper in the peer-reviewed journal Science, detailing the development of a suite of enzymes and their application for site-selective synthesis of insulin bioconjugates. The publication describes the development and optimization of enzymes using the CodeEvolver庐 technology platform.

Upcoming Milestones

• Phenylketonuria (PKU): The Company anticipates that its partner Nestl茅 Health Science will file an Investigational New Drug (IND) application for CDX-6114 for PKU, one of the most common inborn errors of metabolism (IEM) in the second half of 2023.
  
  
• Exocrine Pancreatic Insufficiency (EPI): The Company anticipates that Nestl茅 Health Science will file an IND application for the Phase 2 study of CDX-7108 for the treatment of EPI by the end of 2023. The Phase 2 study is expected to be conducted over approximately 12 months, with topline data anticipated in 2025.
  
  
• Fabry disease: The Company anticipates that its partner Takeda will file an IND application for a Phase 1 study in Fabry disease as soon as late 2023.

Fiscal Year 2022 Financial Highlights

• Total revenues for fiscal year 2022 were $138.6 million, an increase of 32% from $104.8 million the prior year. Excluding enzyme sales related to PAXLOVID鈩�, which were $75.4 million and $34.5 million for 2022 and 2021, respectively, total revenues for fiscal year 2022 were $63.2 million, a decrease of 10% from $70.3 million in the prior year.
  
  
• Product revenues for fiscal year 2022 were $116.7 million, an increase of 65% from $70.7 million the prior year, primarily driven by enzyme sales related to PAXLOVID鈩�. Excluding these sales, total product sales for fiscal year 2022 were $41.3 million, an increase of 14% from $36.1 million in the prior year.
  
  
• R&D revenues were $21.9 million for fiscal year 2022, compared to $34.1 million the prior year. The decrease was driven by lower license fees, decreased revenue from milestone payments, and lower R&D fees from existing collaborating agreements.
  
  
• Product gross margin for fiscal year 2022 was 67%, compared to 69% the prior year. The decrease was primarily driven by sales mix and higher shipping costs.
  
  
• R&D expenses for fiscal year 2022 increased to $80.1 million, compared to $55.9 million the prior year. The increase in R&D expenses was driven by higher costs associated with increased headcount, facilities, lab supplies, depreciation, and outside services.
  
  
• Selling, General & Administrative expenses for fiscal year 2022 were $52.2 million, compared to $49.3 million the prior year. The increase in SG&A expense was the result of higher costs associated with headcount, and outside services, partially offset by lower legal fees.
  
  
• Fiscal year 2022 includes $3.2 million in restructuring charges related to the workforce reduction plan that occurred in the fourth quarter.
  
  
• The net loss for fiscal year 2022 was $33.6 million, or $0.51 per share, compared to $21.3 million, or $0.33 per share, for fiscal year 2021.
  
  
• As of December 31, 2022, 五星体育直播 had $114.0 million in cash and cash equivalents.

Fourth Quarter 2022 Financial Highlights

• Total revenues for the fourth quarter 2022 were $30.4 million, an increase of 24% from $24.5 million in the fourth quarter 2021. Excluding fourth quarter enzyme sales related to PAXLOVID鈩�, which were $17.4 million and $11.3 million for 2022 and 2021, respectively, total revenues for the fourth quarter 2022 were $13.0 million, a decrease of 2% from $13.2 million in the prior year.
  
  
• Product revenues for the fourth quarter 2022 were $23.3 million compared to $17.0 million in the fourth quarter 2021, driven by enzyme sales related to PAXLOVID鈩�.
  
  
• R&D revenues for the fourth quarter 2022 were $7.1 million compared to $7.5 million in the fourth quarter 2021. The decrease was driven by lower license fees, decreased revenue from milestone payments, and lower R&D fees from collaboration agreements.
  
  
• Product gross margin for the fourth quarter 2022 was 64% compared to 60% in the fourth quarter 2021, driven by changes in sales mix.
  
  
• R&D expenses for the fourth quarter 2022 were $19.7 million compared to $16.4 million in the fourth quarter 2021, driven by higher costs associated with increased headcount, facilities, outside services, lab supplies, and depreciation.
  
  
• Selling, General & Administrative expenses for the fourth quarter 2022 were $12.3 million, compared to $11.7 million in the fourth quarter 2021. The increase was primarily the result of higher costs associated with increased headcount, freight, and outside services.
  
  
• Fourth quarter 2022 includes $3.2 million in restructuring charges related to the workforce reduction plan.
  
  
• The net loss for the fourth quarter 2022 was $12.6 million, or $0.19 per share, compared to $10.2 million, or $0.16 per share, for the fourth quarter 2021.

2023 Guidance

五星体育直播 is introducing financial guidance for 2023, as follows:

• Total revenues are expected to be in the range of $63 million to $68 million. This range excludes revenue from enzyme sales related to PAXLOVID鈩�.
  
  
• Product revenues are expected to be in the range of $35 million to $40 million, excluding enzyme sales related to PAXLOVID鈩�.
  
  
• Gross margin on product revenue is expected to be 68% to 73%, excluding enzyme sales related to PAXLOVID鈩�.
  
  
• In addition, 五星体育直播 expects that its existing cash and cash equivalents, combined with the Company鈥檚 future expectations for product revenues, R&D revenues and expense management, will be sufficient to fund its planned operations through the end of 2024.

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 13735352.

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 13726635 to access the recording. A webcast replay will be available on the Investors section of 听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 biotherapeutics. 五星体育直播 enzymes have applications in the sustainable manufacturing of small molecule pharmaceuticals, in RNA and DNA synthesis and the creation of next generation life science tools, and as gene therapies and oral enzyme therapies. 五星体育直播鈥� unique enzymes can drive improvements such as higher yields, reduced energy usage and waste generation, improved return on capital in manufacturing, improved sensitivity in genomic and diagnostic applications, and more efficacious therapeutics. For more information, visit .

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 鈥渁im,鈥� 鈥渁nticipate,鈥� 鈥渁ssume,鈥� 鈥渂elieve,鈥� 鈥渃ontemplate,鈥� 鈥渃ontinue,鈥� 鈥渃ould,鈥� 鈥渄esign,鈥� 鈥渄ue,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥済oal,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渙bjective,鈥� 鈥減lan,鈥� 鈥減ositioned,鈥� 鈥減otential,鈥� 鈥減redict,鈥� 鈥渟eek,鈥� 鈥渟hould,鈥� 鈥渟uggest,鈥� 鈥渢arget,鈥� 鈥渙n track,鈥� 鈥渨ill,鈥� 鈥渨ould鈥� 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. All statements other than statements of historical facts contained in this press release are forward-looking statements. Such forward-looking statements include, but are not limited to, statements regarding anticipated milestones, including product launches; timing of data reports; progression of clinical studies; engagement with regulators, including such engagements made by 五星体育直播鈥� partners; 五星体育直播鈥� expectations regarding 2023 total revenues, product revenues and gross margin on product revenue; its ability to fund planned operations through the end of 2024; and the ability of its evolved strategy to drive long-term success and increased market penetration to deliver value for 五星体育直播 customers and shareholders. 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, including, but not limited to, 五星体育直播 being dependent on its collaborators and any failure to successfully manage these relationships preventing it from developing and commercializing many of its products; 五星体育直播鈥� biotherapeutic programs being early stage, highly regulated and expensive; if Nestl茅 Health Science, Takeda or any other collaborator terminate their development programs under their respective license agreements with 五星体育直播, any potential revenue from those license agreements will be significantly reduced or non-existent; 五星体育直播 may need additional capital in the future in order to expand its business; 五星体育直播鈥� dependency on a limited number of customers and its inability to extend or renew contracts with such customers; if 五星体育直播 is unable to develop and commercialize new products for its target markets; if competitors and potential competitors who have greater resources and experience than 五星体育直播 develop products and technologies that make 五星体育直播鈥� products and technologies obsolete; 五星体育直播 may be unable to obtain regulatory approval for its product candidates given the lengthy, time consuming and inherently unpredictable nature of such approval processes; clinical trials are difficult to design and implement, expensive, time-consuming and involve an uncertain outcome; results of preclinical studies and early clinical trials of product candidates may not be predictive of results of later studies or trials; 五星体育直播 may not be able to maintain orphan drug designations for certain of our product candidates, and may be unable to maintain the benefits associated with orphan drug designation; even if 五星体育直播 obtains regulatory approval for any products that it develop alone or with collaborators, such products will remain subject to ongoing regulatory requirements; and market and economic conditions may negatively impact 五星体育直播鈥� business, financial condition, and share price. 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 that will be filed with the Securities and Exchange Commission (SEC) on or about February 24, 2023, 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. 五星体育直播鈥� results for the quarter and year ended December 31, 2022 are not necessarily indicative of our operating results for any future periods.

Investor Relations Contact:

Argot Partners
Brendan Strong/Carrie McKim
(212) 600-1902
听

Media Relations Contact:

Lauren Musto
(781) 572-1147
听

Financial Tables to Follow

五星体育直播
Condensed Consolidated Statements of Operations
(unaudited)
(In Thousands, Except Per Share Amounts)

听

五星体育直播
Condensed Consolidated Balance Sheets
(unaudited)
(In Thousands)

五星体育直播
Segmented Information
(unaudited)
(In Thousands)

⁽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 and restructuring charges, interest income, and other income (expense), net.

⁽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 and restructuring charges, interest income, and other income (expense), net.

Released February 23, 2023