五星体育直播

五星体育直播 Reports Third Quarter 2018 Financial Results

Total revenues increase 70% to $16.9 million driven by higher product revenue and R&D revenue across an increased number of customers

Conference call begins at 4:30 p.m. Eastern time today

REDWOOD CITY, Calif., Nov. 08, 2018 (GLOBE NEWSWIRE) -- 五星体育直播 (NASDAQ: CDXS), a leading protein engineering company, announces financial results for the three and nine months ended September 30, 2018 and provides a business update.

鈥淲e are pleased to report another quarter of outstanding financial performance with total revenues of $16.9 million, a 70% increase over the prior year,鈥� said 五星体育直播 President and CEO John Nicols. 鈥淎doption of our engineered proteins widened with 12 customers each contributing at least six-digit sales in the quarter. Product revenue was up 21% with a strong showing from Merck along with our first shipments of enzymes to Tate & Lyle for their zero-calorie TASTEVA^庐 M Stevia Sweetener. Research & development (R&D) revenue increased 181% over the prior year and included strong contributions from Tate & Lyle, Nestl茅 Health Science, and our first project with a new global top 10 pharmaceutical customer.

鈥淚n addition, we announced earlier today the top-line results from the first-ever clinical trial with a 五星体育直播-developed biotherapeutic, marking another significant advancement in our novel biotherapeutics program,鈥� Nicols added. 鈥淎ll of the defined endpoints were met in our Phase 1a ascending dose clinical trial in healthy volunteers with CDX-6114, our orally administrable enzyme candidate for the potential treatment of phenylketonuria (PKU).鈥�

Third Quarter Financial Highlights
五星体育直播 is reporting two business segments:听 the Performance Enzymes segment, which consists of its protein catalyst and enzyme product and service offerings with a focus on pharmaceutical, food, molecular diagnostics and other industrial markets; and the Novel Biotherapeutics discovery and development segment.

Total revenues for the third quarter of 2018 were $16.9 million, up 70% from $10.0 million for the third quarter of 2017, with the increase due to both higher product revenue and R&D revenue. Product revenue for the third quarter was $8.4 million, up 21% from $6.9 million for the third quarter of 2017, with the increase due to higher customer demand for enzymes. R&D revenue for the third quarter of 2018 was $8.5 million, up 181% from $3.0 million for the prior-year period, with the increase mainly attributable to collaborations with Tate & Lyle and Nestl茅 Health Science. R&D revenue for the third quarter of 2018 included $3.7 million from the Performance Enzymes segment and $4.8 million from the Novel Biotherapeutics segment. The company recorded no R&D revenue from the Novel Biotherapeutics segment in the third quarter of 2017.

Gross margin on product revenue for the third quarter of 2018 was 55%, up from 43% for the third quarter of 2017, with the increase due to favorable product mix.

R&D expenses were $7.9 million for the third quarter of 2018, compared with $8.1 million for the third quarter of 2017, with the decrease primarily due to lower outside services, partially offset by costs associated with higher headcount and an increase in lab supplies. R&D expenses for the third quarter of 2018 included $4.8 million from the Performance Enzymes segment and $2.9 million from the Novel Biotherapeutics segment. R&D expenses for the third quarter of 2017 included $4.4 million from the Performance Enzymes segment and $3.5 million from the Novel Biotherapeutics segment.

Selling, general and administrative (SG&A) expenses for the third quarter of 2018 were $7.3 million, compared with $8.0 million for the third quarter of 2017, with the decrease primarily due to lower legal expenses partially offset by increases in costs associated with higher headcount and outside services expense. SG&A expenses for the third quarter of 2018 included $1.9 million from the Performance Enzymes segment, $0.2 million from the Novel Biotherapeutics segment and $5.2 million in corporate overhead and depreciation expense. SG&A expenses for the third quarter of 2017 included $1.6 million from Performance Enzymes and $6.4 million in corporate overhead and depreciation expense. The company recorded no SG&A expenses from the Novel Biotherapeutics segment in the third quarter of 2017.

The net loss for the third quarter of 2018 was $2.0 million, or $0.04 per share, compared with a net loss for the third quarter of 2017 of $10.2 million, or $0.21 per share. Non-GAAP net income for the third quarter of 2018 was $91,000, or $0.00 per basic and diluted share, compared with a non-GAAP net loss for the third quarter of 2017 of $8.2 million, or $0.17 per share. A reconciliation of GAAP to non-GAAP measures is provided below.

Year-to-date Financial Results
Total revenues for the nine months ended September 30, 2018 were $44.5 million, up 57% from $28.3 million for the first nine months of 2017, and included $26.2 million in R&D revenue and $18.3 million in product revenue. R&D revenue for the first nine months of 2018 included $15.7 million from the Performance Enzymes segment and $10.5 million from the Novel Biotherapeutics segment. The company recorded no R&D revenue from the Novel Biotherapeutics segment for the first nine months of 2017.

Gross margin on product sales for the first nine months of 2018 and 2017 remained unchanged at 44%.

R&D expenses for the first nine months of 2018 were $22.5 million, compared with $20.2 million for the first nine months of 2017, with the increase primarily due to higher headcount and an increase in lab supplies, partially offset by a decrease in outside services. R&D expenses for the first nine months of 2018 included $14.5 million from the Performance Enzymes segment and $7.3 million from the Novel Biotherapeutics segment. R&D expenses for the first nine months of 2017 included $12.6 million from the Performance Enzymes segment and $7.1 million from the Novel Biotherapeutics segment.

SG&A expenses for the first nine months of 2018 were $22.5 million, compared with $21.1 million for the first nine months of 2017, with the increase due to higher headcount, outside services and stock-based compensation expense offset by lower legal expenses. SG&A expenses for the first nine months of 2018 included $5.7 million from the Performance Enzymes segment, $0.6 million from the Novel Biotherapeutics segment and $16.2 million in corporate overhead and depreciation expense. SG&A expenses for the first nine months of 2017 included $5.2 million from Performance Enzymes and $15.9 million in corporate overhead and depreciation expense. The company recorded no SG&A expenses from the Novel Biotherapeutics segment in the first nine months of 2017.听

The net loss for the first nine months of 2018 was $10.4 million, or $0.20 per share, compared with a net loss for the first nine months of 2017 of $24.0 million, or $0.53 per share. Non-GAAP net loss for the first nine months of 2018 was $3.4 million, or $0.07 per share, compared with non-GAAP net loss for the first nine months of 2017 of $18.0 million, or $0.39 per share.

Cash and cash equivalents as of September 30, 2018 were $54.2 million, compared with $31.2 million as of December 31, 2017.

2018 Financial Outlook

The company is updating its 2018 financial outlook as follows:听

• The total revenue range is narrowed to between $60 million and $62 million, representing an increase of 20% to 24% over 2017;
  
  
• The product revenue range is narrowed to between $25 million and $27 million; and
  
  
• Gross margin on product revenue is raised and is now between 47% and 50%.

Non-GAAP Financial Measures
Consolidated financial information has been presented in accordance with GAAP as well as on a non-GAAP basis. On a non-GAAP basis, financial measures exclude the non-cash items听 depreciation expense and stock-based compensation expense. Non-GAAP financial measures presented are non-GAAP net loss, non-GAAP net loss per share (basic and diluted) and the non-GAAP operating expenses non-GAAP R&D expense and non-GAAP SG&A expense. Non-GAAP operating expenses exclude stock-based compensation expense and depreciation of fixed assets.

五星体育直播 management uses these non-GAAP financial measures to monitor and evaluate the Company鈥檚 operating results and trends on an ongoing basis, and internally for operating, budgeting and financial planning purposes. 五星体育直播 management believes the non-GAAP information is useful for investors by offering them the ability to identify trends in what management considers to be 五星体育直播鈥� core operating results and to better understand how management evaluates the business. These non-GAAP measures have limitations, however, because they do not include all expenses that affect 五星体育直播. These non-GAAP financial measures are not prepared in accordance with, and should not be considered in isolation of, or as an alternative to, measurements required by GAAP, and therefore these non-GAAP results should only be used for evaluation in conjunction with the corresponding GAAP measures. A description of the non-GAAP calculations and reconciliation to comparable GAAP financial measures is provided in the accompanying table entitled 鈥淩econciliation of GAAP to Non-GAAP Financial Measures.鈥�

Conference Call and Webcast
五星体育直播 will hold a conference call and audio webcast today beginning at 4:30 p.m. Eastern time. The conference call dial-in numbers are 855-890-8665 for domestic callers and 720-634-2938 for international callers, and the passcode is 3370326. A live webcast of the call will be available on the Investors section of .

A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers. Please use the passcode 3370326 to access the recording. A webcast replay will be available on the Investors section of for 30 days, beginning approximately two hours after the completion of the call.

About 五星体育直播
五星体育直播听is a leading protein engineering company that applies its proprietary CodeEvolver^庐 technology to develop proteins for a variety of applications, including as biocatalysts for the commercial manufacture of pharmaceuticals, fine chemicals and industrial enzymes, and enzymes as biotherapeutics and for use in molecular diagnostics. 五星体育直播鈥� proven technology enables improvements in protein performance, meeting customer needs for rapid, cost-effective and sustainable manufacturing in multiple commercial-scale implementations of biocatalytic processes. For more information, see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 五星体育直播鈥� expectations regarding 2018 total revenues, product revenue and gross margin on product revenue, and continuing clinical development of CDX-6114. 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: the uncertainties inherent in research and the clinical development process, including risks, uncertainties and costs associated with the successful development of biotherapeutic candidates, including obtaining development partners for 五星体育直播鈥� unpartnered biotherapeutic programs and progressing such programs to clinical trials and regulatory approvals; 五星体育直播鈥� dependence on its licensees and collaborators, including 五星体育直播鈥� dependence on Nestl茅 Health Science for the successful development and commercialization of CDX-6114; 五星体育直播鈥� dependence on a limited number of products and customers in its biocatalysis business; potential adverse effects to 五星体育直播鈥� business if its customers鈥� pharmaceutical or food products are not received well in the markets; risks, uncertainties and costs associated with the successful development of biotherapeutic candidates, including obtaining development partners for its biotherapeutic programs and progressing such programs to clinical trials and regulatory approvals; 五星体育直播鈥� ability to develop and commercialize new products for the biocatalysis markets; 五星体育直播鈥� dependence on a limited number of contract manufacturers for large-scale production of its enzymes; 五星体育直播鈥� ability to deploy its technology platform in new market spaces, including the fine chemicals, therapeutics and in vitro molecular diagnostics markets; 五星体育直播鈥� ability to comply with the terms of its credit facility and its associated debt service obligations; 五星体育直播鈥� need for additional capital in the future in order to expand its business or to adjust for market conditions or strategic considerations, which may involve 五星体育直播 entering into equity offerings, debt financings, credit facilities and/or strategic collaborations; 五星体育直播鈥� dependence on key personnel; 五星体育直播鈥� ability to establish and maintain adequate protection for intellectual property, trade secrets and other proprietary rights covering its technologies; and any claims by third parties that 五星体育直播 is infringing their intellectual property rights or other proprietary rights. 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 15, 2018 and Form 10-Q filed with the SEC on August 9, 2018, 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 Contact:
LHA Investor Relations
Jody Cain, 310-691-7100 听

Financial Tables to Follow

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

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

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

五星体育直播
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
(In Thousands, Except Per Share Amounts)

These non-GAAP financial measures exclude the following items:

(a) Depreciation expense: we provide non-GAAP information which excludes depreciation expense related to the depreciation of property and equipment. We believe that eliminating this expense from our non-GAAP measures is useful to investors, because the acquisition of property and equipment, and the corresponding depreciation expense, can be inconsistent in amount and can vary from period to period.

(b) Stock-based compensation expense: we provide non-GAAP information which excludes expenses for stock-based compensation. We believe the exclusion of this item allows for financial results that are more indicative of our operations. We also believe that the exclusion of stock-based compensation expense provides for a better comparison of 五星体育直播' operating results to prior periods as the calculations of stock-based compensation vary from period to period and company to company due to different valuation methodologies, subjective assumptions and the variety of award types.

Released November 8, 2018