五星体育直播 Reports Third Quarter 2022 Financial Results

Reiterates 2022 Total Revenue Guidance of $135M-$141M,听Including Product Revenues of $112M-$118M

REDWOOD CITY, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- 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 third quarter ended September听30, 2022 and provided a business update.

鈥淚n the last few months, the leadership team and I have been working to refine 五星体育直播鈥 strategy by assessing the markets where 五星体育直播 and our proprietary CodeEvolver庐 platform have a clear competitive advantage,鈥 said Dr. Stephen Dilly, President and CEO of 五星体育直播. 鈥淲e believe our evolved strategy will position the Company nicely to drive long-term success and increased market penetration by focusing our resources and concentrating our spend on programs where we are positioned to win. I look forward to sharing additional detail on the go-forward plan in the coming months as we solidify our strategy to deliver value for 五星体育直播 customers and shareholders.鈥

Key Business Highlights

  • Product revenues decreased 2% to $28.0 million in the third quarter of 2022. Excluding revenue from sales of CDX-616 used in the manufacture of Pfizer鈥檚 COVID-19 therapeutic (PAXLOVID鈩) in both periods, product revenues increased 53% to $15.1 million in the third quarter of 2022, up from $9.9 million in the third quarter of 2021. Revenues attributable to enzymes sales to Pfizer for the manufacture of PAXLOVID鈩 were $12.9 million in the third quarter of 2022 compared to $18.9 million last year.

  • Executive Leadership Updates

    • Dr. Stephen Dilly was appointed as the President and CEO of 五星体育直播. Dr. Dilly has more than three decades of executive management experience in the biopharmaceutical industry, most recently having served as President and CEO of Sierra Oncology through its recent sale to GlaxoSmithKline for $1.9 billion.

    • Kevin Norrett was appointed as the Chief Operating Officer of 五星体育直播. Mr. Norrett brings more than 20 years of experience across commercial, business and corporate development, operations and finance. He is responsible for driving the Company鈥檚 corporate growth strategy, business development and operational activities.

    • Margaret Fitzgerald was appointed as General Counsel of 五星体育直播. Ms. Fitzgerald has almost two decades of legal experience in the biotechnology field, with a background spanning complex transactions, intellectual property and portfolio management, and commercializing therapeutics.

  • The Company announced the appointment of Rahul Singhvi, Sc.D. to its Board of Directors. Currently the CEO of National Resilience, a technology-focused biomanufacturing company, Dr. Singhvi is a biotechnology industry veteran with more than 30 years of research and development, operations and commercialization expertise across several modalities including cell and gene therapies, nucleic acids, vaccines and biologics.

  • 五星体育直播 hosted its 2022 Protein Engineering Forum, bringing over 100 top scientists and innovators together for two days of presentations and networking events to facilitate the sharing of insights and recent technological advancements throughout genomics, nucleic acid synthesis and synthetic biology.

Third Quarter 2022 Financial Highlights

  • Total revenues for the third quarter 2022 were $34.5 million, a decrease of 6% from $36.8 million in the third quarter 2021. On a segment basis, $31.1 million in revenue was from the Performance Enzymes segment and $3.3 million was from Biotherapeutics.

  • Product revenues for the third quarter 2022 were $28.0 million compared to $28.7 million in the third quarter 2021; the decrease was primarily driven by lower enzyme sales related to PAXLOVID鈩.

  • R&D revenues for the third quarter 2022 were $6.4 million compared to $8.0 million in the third quarter 2021; the decrease was driven by lower revenues from several of our large, existing customers.

  • Product gross margin for the third quarter 2022 was 65% compared to 76% in the third quarter 2021. The decrease was largely driven by changes in product mix, particularly the decline in sales related to PAXLOVID, variations in prices for volume sold and higher shipping costs.

  • R&D expenses for the third quarter 2022 were $21.8 million compared to $15.2 million in the third quarter 2021. The increase was primarily driven by higher costs associated with increased headcount and salaries as well as higher expenses for facilities and outside services.

  • Selling, General & Administrative expenses for the third quarter 2022 were $13.5 million, compared to $13.4 million in the third quarter 2021. SG&A expenses were flat, primarily, because higher compensation-related expenses were offset by decreases in legal costs.

  • The net loss for the third quarter 2022 was $10.0 million, or $0.15 per share, compared to a net income of $2.2 million, or $0.03 per share, for the third quarter 2021.

  • As of September听30, 2022, the Company had $108.7 million in cash and cash equivalents.

2022 Guidance

五星体育直播 reiterated its financial guidance for 2022 issued on July 14, 2022, as follows:

  • Total revenues are expected to be in the range of $135 million to $141 million.

  • Product revenues are expected to be in the range of $112 million to $118 million, including approximately $75 million from Pfizer.

  • Gross margin on product revenue is expected to be in the range of 65% to 70%.

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 at least 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 Investors section of the Company鈥檚 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 13732962.

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 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 pharmaceuticals, food and industrial products; in the creation of the next generation of life science tools; and as gene therapy and oral enzyme therapies. The Company鈥檚 unique performance enzymes drive improvements such as: reduced energy usage, waste generation and capital requirements; 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 .听

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, without limitation, 五星体育直播鈥 expectations regarding 2022 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. 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 February听28, 2022 and in 五星体育直播鈥 Quarterly Report on Form 10-Q filed with the SEC on August 5, 2022, 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
Brendan Strong/Carrie McKim
(212) 600-1902

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

Three Months Ended September 30, Nine Months Ended September 30,
2022 2021 2022 2021
Revenues:
Product revenue $ 28,042 $ 28,731 $ 93,376 $ 53,674
Research and development revenue 6,428 8,038 14,839 26,579
Total revenues 34,470 36,769 108,215 80,253
Costs and operating expenses:
Cost of product revenue 9,786 6,867 29,577 15,403
Research and development 21,821 15,165 60,410 39,562
Selling, general and administrative 13,499 13,407 39,859 37,600
Total costs and operating expenses 45,106 35,439 129,846 92,565
Income (loss) from operations (10,636 ) 1,330 (21,631 ) (12,312 )
Interest income 436 41 618 424
Other income, net 216 983 150 920
Income (loss) before income taxes (9,984 ) 2,354 (20,863 ) (10,968 )
Provision for income taxes 8 110 125 121
Net income (loss) $ (9,992 ) $ 2,244 $ (20,988 ) $ (11,089 )
Net income (loss) per share, basic $ (0.15 ) $ 0.03 $ (0.32 ) $ (0.17 )
Net income (loss) per share, diluted $ (0.15 ) $ 0.03 $ (0.32 ) $ (0.17 )
Weighted average common stock shares used in computing net income (loss) per share, basic 65,426 64,628 65,271 64,452
Weighted average common stock shares used in computing net income (loss) per share, diluted 65,426 67,741 65,271 64,452

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

September 30, 2022 December 31, 2021
Assets
Current assets:
Cash and cash equivalents $ 108,689 $ 116,797
Restricted cash, current 528 579
Financial assets:
Accounts receivable 16,527 24,953
Contract assets 5,867 4,557
Unbilled receivables 7,490 8,558
Total financial assets 29,884 38,068
Less: allowances (109 ) (416 )
Total financial assets, net 29,775 37,652
Inventories 1,623 1,160
Prepaid expenses and other current assets 5,382 5,700
Total current assets 145,997 161,888
Restricted cash 1,520 1,519
Investment in non-marketable equity securities 20,510 14,002
Right-of-use assets - Operating leases, net 40,493 44,095
Right-of-use assets - Finance leases, net 17
Property and equipment, net 23,319 21,345
Goodwill 3,241 3,241
Other non-current assets 208 276
Total assets $ 235,288 $ 246,383
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 2,621 $ 2,995
Accrued compensation 9,463 11,119
Other accrued liabilities 12,992 12,578
Current portion of lease obligations - Operating leases 5,230 4,093
Deferred revenue 1,602 2,586
Total current liabilities 31,908 33,371
Deferred revenue, net of current portion 8,238 3,749
Long-term lease obligations - Operating leases 39,655 43,561
Other long-term liabilities 1,356 1,311
Total liabilities 81,157 81,992
Stockholders' equity:
Common stock 6 6
Additional paid-in capital 562,811 552,083
Accumulated deficit (408,686 ) (387,698 )
Total stockholders' equity 154,131 164,391
Total liabilities and stockholders' equity $ 235,288 $ 246,383

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

Three Months Ended September 30, 2022 Three Months Ended September 30, 2021
Performance Enzymes Novel Biotherapeutics Total Performance Enzymes Novel Biotherapeutics Total
Revenues:
Product revenue $ 28,042 $ $ 28,042 $ 28,731 $ $ 28,731
Research and development revenue 3,104 3,324 6,428 3,853 4,185 8,038
Total revenues 31,146 3,324 34,470 32,584 4,185 36,769
Costs and operating expenses:
Cost of product revenue 9,786 9,786 6,867 6,867
Research and development(1) 6,782 13,855 20,637 5,670 8,850 14,520
Selling, general and administrative(1) 3,791 888 4,679 3,306 831 4,137
Total segment costs and operating expenses 20,359 14,743 35,102 15,843 9,681 25,524
Income (loss) from operations $ 10,787 $ (11,419 ) (632 ) $ 16,741 $ (5,496 ) 11,245
Corporate costs(2) (7,947 ) (8,097 )
Unallocated depreciation and amortization (1,405 ) (794 )
Income (loss) before income taxes $ (9,984 ) $ 2,354

(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, net.

Nine Months Ended September 30, 2022 Nine Months Ended September 30, 2021
Performance Enzymes Novel Biotherapeutics Total Performance Enzymes Novel Biotherapeutics Total
Revenues:
Product revenue $ 93,376 $ $ 93,376 $ 53,674 $ $ 53,674
Research and development revenue 7,398 7,441 14,839 14,723 11,856 26,579
Total revenues 100,774 7,441 108,215 68,397 11,856 80,253
Costs and operating expenses:
Cost of product revenue 29,577 29,577 15,403 15,403
Research and development(1) 19,833 37,279 57,112 17,172 20,649 37,821
Selling, general and administrative(1) 11,208 2,288 13,496 9,294 2,052 11,346
Total segment costs and operating expenses 60,618 39,567 100,185 41,869 22,701 64,570
Income (loss) from operations $ 40,156 $ (32,126 ) 8,030 $ 26,528 $ (10,845 ) 15,683
Corporate costs(2) (24,940 ) (24,431 )
Unallocated depreciation and amortization (3,953 ) (2,220 )
Loss before income taxes $ (20,863 ) $ (10,968 )

(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, net.


Source: 五星体育直播