EX-99.1
Published on November 4, 2021
Exhibit 99.1
五星体育直播 Reports Third Quarter 2021 Financial Results
Record Quarterly Total Revenue, Product Revenue and Product Gross Margin
Reiterating Total Revenue Guidance of $98-103M; Raising Product Revenue Guidance to $63-66M
REDWOOD CITY Calif., November 4, 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 third quarter ended September听30, 2021 and provided a business update.
鈥溛逍翘逵辈� delivered another quarter of exceptional strategic and operational performance,鈥� said John Nicols, 五星体育直播 President and CEO. 鈥淥ur Sustainable Manufacturing business demonstrated remarkable growth, as we significantly executed against the large enzyme orders we received from Pfizer to support its COVID-19 antiviral therapeutic candidate. Our capacity to fulfill this order in such a rapid timeframe highlights the strength of our supply chain and the value of our deep library of performance enzymes. Also in the third quarter, with Merck and Almelo, we established our first two multi-year agreements to extend our longstanding sitagliptin product business into its generic chapter. We also delivered strong results in the faster-to-market food sector, including enzyme sales for Tate & Lyle sweeteners and a milestone from Kalsec for their newest natural hop ingredient.
鈥淚n the Life Science Tools market, we are extremely pleased to have recorded our first sales of Codex庐 HiFi DNA Polymerase in the third quarter. We remain on track with our groundbreaking collaboration with Molecular Assemblies (MAI) for the commercialization of enzymatic DNA synthesis. Underscoring our enthusiasm for this disruptive approach, we recently made an additional investment in MAI alongside Casdin Capital enabled by our SynBio Innovation Accelerator. Our high-value Biotherapeutics pipeline is also advancing steadily, including the recent initiation of our Phase 1 clinical trial of CDX-7108, our program co-owned with Nestl茅 Health Science, for the treatment of exocrine pancreatic insufficiency. 五星体育直播 remains on the cutting edge of synthetic biology鈥檚 evolution, leveraging the near-boundless potential of our enzymes to improve the health of people and the planet.鈥�
Key Performance Indicators and Recent Business Highlights
鈥�Product revenues increased 242% to $28.7 million in Q3鈥�21, primarily driven by the sale of a proprietary 五星体育直播 enzyme to manufacture Pfizer鈥檚 clinical-stage COVID antiviral therapeutic candidate.
鈥�Product gross margin increased to a record 76% in Q3鈥�21, driven by a shift in the sales mix to higher margin products.
鈥�In the third quarter, 五星体育直播 had 19 customers who contributed over $100,000 in revenue, seven of which contributed over $1 million in revenue.
鈥�In the Sustainable Manufacturing market of the Performance Enzymes segment, in August 五星体育直播 received two new purchase orders for approximately $15.0 million for a proprietary 五星体育直播 enzyme to manufacture Pfizer鈥檚 clinical-stage COVID antiviral therapeutic candidate, PF-07321332. This followed a large order of $13.9 million for this enzyme that 五星体育直播 received in June. In aggregate, the orders the Company received in June and August total approximately $29.0 million.
五星体育直播 amended and extended its agreement with Merck to license and supply a proprietary enzyme used in the manufacturing process for sitagliptin, the active pharmaceutical ingredient (API) in Merck鈥檚 JANUVIA庐 and JANUMET庐. The Company also recently announced a tri-party collaboration agreement with Almelo Private, Ltd., an Indian producer of APIs, and RC2 Pharma Connect, LLC, a U.S.-based leading pharmaceutical
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manufacturing representative, to license and manufacture 五星体育直播鈥� proprietary enzyme for sitagliptin to be used in the manufacture of sitagliptin for the future generic market.
五星体育直播 announced an expanded, exclusive commercial supply agreement with Kalsec for a novel enzyme to sustainably produce their natural, clean-label hop ingredient. The Company also earned a milestone from Kalsec in the quarter for Generally Recognized as Safe (GRAS) self-affirmation of this enzyme.
鈥�In the Life Science Tools market within the Performance Enzymes segment 五星体育直播 recorded its first commercial sale of Codex庐 HiFi DNA polymerase in the third quarter. The Company expects to launch Codex庐 Reverse Transcriptase into sequencing applications in December.
Enabled by the SynBio Innovation Accelerator, 五星体育直播 made an additional $7.0 million investment in Molecular Assemblies (MAI), alongside a $3.0 million investment by Casdin Capital in MAI.
鈥�In the Novel Biotherapeutics segment, 五星体育直播鈥� pipeline includes 13 programs. The Company recently announced the initiation of a Phase 1 clinical trial of CDX-7108, which is co-owned with Nestl茅 Health Science, for the treatment of exocrine pancreatic insufficiency.
Third Quarter 2021 Financial Highlights
鈥�Total revenues for the third quarter 2021 were $36.8 million, an increase of 100% from $18.4 million in the third quarter 2020. On a segment basis, $32.6 million in revenue was from the Performance Enzymes segment and $4.2 million was from the Novel Biotherapeutics segment. Product revenues for the third quarter 2021 were $28.7 million compared to $8.4 million in the third quarter 2020; the increase was the result of higher sales of enzymes used to manufacture branded pharmaceutical products, primarily Pfizer. R&D revenues were $8.0 million compared to $10.0 million last year. The decrease was driven by lower R&D revenue from several large pharmaceutical companies and a shift towards more self-funded R&D programs.
鈥�Product gross margin for the third quarter 2021 was 76% compared to 57% in the third quarter 2020. The increase was driven by increased sales of higher margin products.
鈥�R&D expenses for the third quarter 2021 were $15.2 million compared to $12.0 million in the third quarter 2020. The increase was driven by higher compensation expenses driven primarily by higher headcount, cost of lab supplies and depreciation, partially offset by lower preclinical development and regulatory expenses.
鈥�Selling, General & Administrative expenses for the third quarter 2021 were $13.4 million, compared to $8.8 million in the third quarter 2020. The increase was the result of higher expenses for compensation, primarily driven by higher headcount, and higher legal fees.
鈥�Net income for the third quarter 2021 was $2.2 million, or $0.03 per share, compared to a net loss of $6.1 million, or $0.10 per share, for the third quarter 2020. As of September听30, 2021, the Company had $119.2 million in cash and cash equivalents.
Guidance
五星体育直播 is updating its financial guidance issued on August 5, 2021, as follows:
鈥�FY 2021 total revenues continue to be expected in the range of $98 - $103 million
鈥�FY 2021 product revenues are now expected to be in the range of $63 - $66 million compared to $59 - $63 million previously
鈥�FY 2021 gross margin on product revenue is expected to be in the range of 68% to 71% compared to 65% to 68% previously
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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 (866) 682-6100 for domestic callers and (862) 298-0702 for international callers, and the passcode is 13724176.
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; in the creation of the next generation of life science tools; and as gene therapy and biologic therapeutics. 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 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 and product margin growth in 五星体育直播鈥� Sustainable Manufacturing business; 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 August 6, 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 September 30, | Nine Months Ended September 30, | |||||||||||||||||||||
| 听 | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| Product revenue | $ | 28,731听 | $ | 8,401听 | $ | 53,674听 | $ | 18,005听 | |||||||||||||||
| Research and development revenue | 8,038听 | 9,984听 | 26,579听 | 30,018听 | |||||||||||||||||||
| Total revenues | 36,769听 | 18,385听 | 80,253听 | 48,023听 | |||||||||||||||||||
| Costs and operating expenses: | |||||||||||||||||||||||
| Cost of product revenue | 6,867听 | 3,642听 | 15,403听 | 7,882听 | |||||||||||||||||||
| Research and development | 15,165听 | 12,010听 | 39,562听 | 33,830听 | |||||||||||||||||||
| Selling, general and administrative | 13,407听 | 8,797听 | 37,600听 | 26,307听 | |||||||||||||||||||
| Total costs and operating expenses | 35,439听 | 24,449听 | 92,565听 | 68,019听 | |||||||||||||||||||
| Income (loss) from operations | 1,330听 | (6,064) | (12,312) | (19,996) | |||||||||||||||||||
| Interest income | 41听 | 39听 | 424听 | 362听 | |||||||||||||||||||
| Other income (expense), net | 983听 | (50) | 920听 | (125) | |||||||||||||||||||
| Income (loss) before income taxes | 2,354听 | (6,075) | (10,968) | (19,759) | |||||||||||||||||||
| Provision for income taxes | 110听 | 19听 | 121听 | 331听 | |||||||||||||||||||
| Net income (loss) | $ | 2,244听 | $ | (6,094) | $ | (11,089) | $ | (20,090) | |||||||||||||||
| Net income (loss) per share, basic | $ | 0.03听 | $ | (0.10) | $ | (0.17) | $ | (0.34) | |||||||||||||||
| Net income (loss) per share, diluted | $ | 0.03听 | $ | (0.10) | $ | (0.17) | $ | (0.34) | |||||||||||||||
| Weighted average common stock shares used in computing net income (loss) per share, basic | 64,628听 | 59,061听 | 64,452听 | 58,984听 | |||||||||||||||||||
| Weighted average common stock shares used in computing net income (loss) per share, diluted | 67,741听 | 59,061听 | 64,452听 | 58,984听 | |||||||||||||||||||
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五星体育直播
Condensed Consolidated Balance Sheets
(Unaudited)
(In Thousands)
| September 30, 2021 |
December 31, 2020 |
||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 119,189听 | $ | 149,117听 | |||||||
| Restricted cash, current | 581听 | 638听 | |||||||||
| Investment in non-marketable debt security | 鈥斕� | 1,000听 | |||||||||
| Financial assets: | |||||||||||
| 听听听听听Accounts receivable | 25,084听 | 13,894听 | |||||||||
| 听听听听听Contract assets | 12,701听 | 4,526听 | |||||||||
| Unbilled receivables | 10,760听 | 10,942听 | |||||||||
| 听听听听听听听听Total financial assets | 48,545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 | 48,471听 | 29,288听 | |||||||||
| Inventories | 1,084听 | 964听 | |||||||||
| Prepaid expenses and other current assets | 4,787听 | 3,416听 | |||||||||
| Total current assets | 174,112听 | 184,423听 | |||||||||
| Restricted cash | 1,519听 | 1,062听 | |||||||||
| Investment in non-marketable equity securities | 12,763听 | 1,450听 | |||||||||
| Right-of-use assets - Operating leases, net | 19,478听 | 21,382听 | |||||||||
| Right-of-use assets - Finance leases, net | 43听 | 119听 | |||||||||
| Property and equipment, net | 16,124听 | 9,675听 | |||||||||
| Goodwill | 3,241听 | 3,241听 | |||||||||
| Other non-current assets | 271听 | 294听 | |||||||||
| Total assets | $ | 227,551听 | $ | 221,646听 | |||||||
| Liabilities and Stockholders' Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 3,281听 | $ | 2,970听 | |||||||
| Accrued compensation | 9,041听 | 7,288听 | |||||||||
| Other accrued liabilities | 15,927听 | 10,272听 | |||||||||
| Current portion of lease obligations - Operating leases | 2,782听 | 2,627听 | |||||||||
| Deferred revenue | 2,449听 | 1,824听 | |||||||||
| Total current liabilities | 33,480听 | 24,981听 | |||||||||
| Deferred revenue, net of current portion | 3,747听 | 2,967听 | |||||||||
| Long-term lease obligations - Operating leases | 20,218听 | 22,324听 | |||||||||
| Other long-term liabilities | 1,051听 | 1,271听 | |||||||||
| Total liabilities | 58,496听 | 51,543听 | |||||||||
| Stockholders' equity: | |||||||||||
| Common stock | 6听 | 6听 | |||||||||
| Additional paid-in capital | 546,557听 | 536,516听 | |||||||||
| Accumulated deficit | (377,508) | (366,419) | |||||||||
| Total stockholders' equity | 169,055听 | 170,103听 | |||||||||
| Total liabilities and stockholders' equity | $ | 227,551听 | $ | 221,646听 | |||||||
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五星体育直播
Segmented Information
(Unaudited)
(In Thousands)
| 听 | Three months ended September 30, 2021 | Three months ended September 30, 2020 | |||||||||||||||||||||||||||||||||
| 听 | Performance Enzymes | Novel Biotherapeutics | Total | Performance Enzymes | Novel Biotherapeutics | Total | |||||||||||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||||||||||||||
| Product revenue | $ | 28,731听 | $ | 鈥斕� | $ | 28,731听 | $ | 8,401听 | $ | 鈥斕� | $ | 8,401听 | |||||||||||||||||||||||
| Research and development revenue | 3,853听 | 4,185听 | 8,038听 | 4,604听 | 5,380听 | 9,984听 | |||||||||||||||||||||||||||||
| Total revenues | 32,584听 | 4,185听 | 36,769听 | 13,005听 | 5,380听 | 18,385听 | |||||||||||||||||||||||||||||
| Costs and operating expenses: | |||||||||||||||||||||||||||||||||||
| Cost of product revenue | 6,867听 | 鈥斕� | 6,867听 | 3,642听 | 鈥斕� | 3,642听 | |||||||||||||||||||||||||||||
Research and development (1)
|
5,670听 | 8,850听 | 14,520听 | 5,184听 | 6,433听 | 11,617听 | |||||||||||||||||||||||||||||
Selling, general and administrative(1)
|
3,306听 | 831听 | 4,137听 | 2,675听 | 515听 | 3,190听 | |||||||||||||||||||||||||||||
| Total segment costs and operating expenses | 15,843听 | 9,681听 | 25,524听 | 11,501听 | 6,948听 | 18,449听 | |||||||||||||||||||||||||||||
| Income (loss) from operations | $ | 16,741听 | $ | (5,496) | 11,245听 | $ | 1,504听 | $ | (1,568) | (64) | |||||||||||||||||||||||||
Corporate costs (2)
|
(8,097) | (5,483) | |||||||||||||||||||||||||||||||||
| Unallocated depreciation and amortization | (794) | (528) | |||||||||||||||||||||||||||||||||
| Income (loss) before income taxes | $ | 2,354听 | $ | (6,075) | |||||||||||||||||||||||||||||||
(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 | Nine months ended September 30, 2021 | Nine months ended September 30, 2020 | |||||||||||||||||||||||||||||||||
| 听 | Performance Enzymes | Novel Biotherapeutics | Total | Performance Enzymes | Novel Biotherapeutics | Total | |||||||||||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||||||||||||||
| Product revenue | $ | 53,674听 | $ | 鈥斕� | $ | 53,674听 | $ | 18,005听 | $ | 鈥斕� | $ | 18,005听 | |||||||||||||||||||||||
| Research and development revenue | 14,723听 | 11,856听 | 26,579听 | 13,380听 | 16,638听 | 30,018听 | |||||||||||||||||||||||||||||
| Total revenues | 68,397听 | 11,856听 | 80,253听 | 31,385听 | 16,638听 | 48,023听 | |||||||||||||||||||||||||||||
| Costs and operating expenses: | |||||||||||||||||||||||||||||||||||
| Cost of product revenue | 15,403听 | 鈥斕� | 15,403听 | 7,882听 | 鈥斕� | 7,882听 | |||||||||||||||||||||||||||||
Research and development (1)
|
17,172听 | 20,649听 | 37,821听 | 15,877听 | 16,848听 | 32,725听 | |||||||||||||||||||||||||||||
Selling, general and administrative(1)
|
9,294听 | 2,052听 | 11,346听 | 7,395听 | 1,728听 | 9,123听 | |||||||||||||||||||||||||||||
| Total segment costs and operating expenses | 41,869听 | 22,701听 | 64,570听 | 31,154听 | 18,576听 | 49,730听 | |||||||||||||||||||||||||||||
| Income (loss) from operations | $ | 26,528听 | $ | (10,845) | 15,683听 | $ | 231听 | $ | (1,938) | (1,707) | |||||||||||||||||||||||||
Corporate costs (2)
|
(24,431) | (16,526) | |||||||||||||||||||||||||||||||||
| Unallocated depreciation and amortization | (2,220) | (1,526) | |||||||||||||||||||||||||||||||||
| Loss before income taxes | $ | (10,968) | $ | (19,759) | |||||||||||||||||||||||||||||||
(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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