五星体育直播 Reports 2018 Fourth Quarter and Full Year Financial Results

2018 revenues of $61 million include a 50% increase in R&D revenue听
Introduces 2019 financial guidance

Conference call begins at 4:30 pm Eastern time today
Accompanying slide presentation available on Investor section of company website

REDWOOD CITY, Calif., Feb. 26, 2019 (GLOBE NEWSWIRE) -- 五星体育直播 (NASDAQ: CDXS), a leading protein engineering company, announces financial results for the three and 12 months ended December听31, 2018, provides a business update and introduces 2019 financial guidance.

鈥淲e closed a highly productive year with revenues of $61 million, up 21% from the prior year, as we met or exceeded all guidance metrics for the fifth consecutive year,鈥 said 五星体育直播 President and CEO John Nicols. 鈥淥ur growth was driven by a 50% increase in R&D revenue. Product revenue of $26 million met our outlook and gross margin on product revenue of 51% was above our guidance range. Besides these excellent financial accomplishments in 2018, we delivered strategic advancements across our business segments.听 In Performance Enzymes, we announced and advanced a new pharma partnership with Porton Pharma Solutions, plus commercialized a suite of proprietary high-performing enzymes for the production of Tate & Lyle鈥檚 Tasteva M stevia sweetener.听 In Novel Biotherapeutics, we successfully completed our first-ever clinical trial.听 Our execution enabled our partner, Nestl茅 Health Science, to exercise their option in recent weeks for the licensing of our first self-funded biotherapeutic candidate, CDX-6114, for the potential treatment of phenylketonuria.

鈥淥ur outlook for 2019 is for another solid performance, with year-over-year revenue growth expected between 14% and 19%,鈥 he added. 鈥淲e are lined up to strategically advance in both business segments again as well.听 In Performance Enzymes, we anticipate a growing list of deepening pharmaceutical relationships, significant market penetration of molecular diagnostics markets, and expansion of industrial enzyme development partnerships.听 In Novel Biotherapeutics, we are accelerating the discovery and development programs, and expect two additional biotherapeutic candidates to be at the partnerable stage before the end of the year.鈥

Fourth 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 fourth quarter of 2018 were $16.1 million compared with $21.7 million for the fourth quarter of 2017, which included the recognition of $1.7 million of non-recurring revenue in connection a revenue-sharing arrangement that was terminated in the fourth quarter of 2017. Product revenue for the fourth quarter of 2018 was $7.3 million compared with $7.6 million for the fourth quarter of 2017, with the decrease due to timing in the demand for various enzymes. R&D revenue for the fourth quarter of 2018 was $8.8 million, compared with $14.2 million for the prior-year period, which included initial R&D revenue under the agreement with Nestle Health Science. R&D revenue for the fourth quarter of 2018 included $5.8 million from the Performance Enzymes segment and $3.0 million from the Novel Biotherapeutics segment. R&D revenue for the fourth quarter of 2017 included $6.5 million for the Performance Enzymes segment and $7.7 million from the Novel Biotherapeutics segment.

Gross margin on product revenue for the fourth quarter of 2018 was 67%, up from 53% for the fourth quarter of 2017, with the increase due to favorable product mix.

R&D expenses were $7.5 million for the fourth quarter of 2018, compared with $9.4 million for the fourth quarter of 2017, with the decrease primarily due to lower consulting fees and outside services related to CDX-6114, partially offset by higher expense related to headcount. R&D expenses for the fourth quarter of 2018 included $4.4 million from the Performance Enzymes segment and $2.9 million from the Novel Biotherapeutics segment. R&D expenses for the fourth quarter of 2017 included $4.3 million from the Performance Enzymes segment and $5.0 million from the Novel Biotherapeutics segment.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2018 were $6.8 million, compared with $7.9 million for the fourth quarter of 2017, with the decrease primarily due to lower legal fees, and lower stock-based compensation expense, partially offset by higher consulting and accounting fees. SG&A expenses for the fourth quarter of 2018 included $1.8 million from the Performance Enzymes segment, $0.2 million from the Novel Biotherapeutics segment and $4.9 million in corporate overhead and depreciation expense. SG&A expenses for the fourth quarter of 2017 included $2.1 million from the Performance Enzymes segment and $5.9 million in corporate overhead and depreciation expense. The company recorded no SG&A expenses from the Novel Biotherapeutics segment in the fourth quarter of 2017.

The net loss for the fourth quarter of 2018 was $0.5 million, or $0.01 per share, compared with net income for the fourth quarter of 2017 of $1.0 million, or $0.02 per basic and diluted share. Non-GAAP net income for the fourth quarter of 2018 was $1.6 million, or $0.03 per basic and diluted share, compared with non-GAAP net income for the fourth quarter of 2017 of $3.1 million, or $0.06 per basic and diluted share. A reconciliation of GAAP to non-GAAP measures is provided below.

2018 Financial Results
Total revenues for 2018 were $60.6 million, up 21% from $50.0 million for 2017, and included $35.0 million in R&D revenue and $25.6 million in product revenue. R&D revenue for 2018 included $21.5 million from the Performance Enzymes segment and $13.5 million from the Novel Biotherapeutics segment. R&D revenue for 2017 included $15.6 million from the Performance Enzymes segment and $7.7 million from the Novel Biotherapeutics segment.

Gross margin on product sales for 2018 was 51%, an increase from 46% for 2017 due to improved sales mix.

R&D expenses for 2018 were $30.0 million, compared with $29.7 million for 2017, with the increase primarily due to higher headcount, allocation of occupancy-related costs and increases in lab supplies and stock-based compensation expense, partially offset by a decrease in outside services. R&D expenses for 2018 included $18.9 million from the Performance Enzymes segment and $10.2 million from the Novel Biotherapeutics segment. R&D expenses for 2017 included $16.8 million from the Performance Enzymes segment and $12.1 million from the Novel Biotherapeutics segment.

SG&A expenses for 2018 were $29.3 million, compared with $29.0 million for 2017, with the increase due to higher headcount, consulting and outside services, accounting fees, recruiting fees and stock-based compensation expense partially offset by a decrease in legal expenses. SG&A expenses for 2018 included $7.5 million from the Performance Enzymes segment, $0.8 million from the Novel Biotherapeutics segment and $21.5 million in corporate overhead and depreciation expense. SG&A expenses for 2017 included $7.4 million from Performance Enzymes and $22.3 million in corporate overhead and depreciation expense. The company recorded no SG&A expenses from the Novel Biotherapeutics segment for 2017.

The net loss for 2018 was $10.9 million, or $0.21 per share, compared with a net loss for 2017 of $23.0 million, or $0.50 per share. Non-GAAP net loss for 2018 was $1.8 million, or $0.04 per share, compared with non-GAAP net loss for 2017 of $14.9 million, or $0.32 per share.

Cash and cash equivalents as of December 31, 2018 were $53.0 million, compared with $31.2 million as of December 31, 2017.

2019 Financial Outlook
五星体育直播 is introducing financial guidance for 2019, as follows:

  • Total revenues are expected to be $69 million to $72 million;
  • Product sales are expected to be $26 million to $29 million; and
  • Gross margin on product sales is expected to be 48% to 52%.

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 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. A slide presentation to accompany the conference call will be available on the 听section of company website. The conference call dial-in numbers are 855-890-8665 for domestic callers and 720-634-2938 for international callers, and the passcode is 1467218. 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 1467218 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
五星体育直播听is a leading protein engineering company that applies its proprietary CodeEvolver 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 2019 total revenues, product revenue and gross margin on product revenue, and growth prospects for its Performance Enzyme business, and the discovery, development and prospects of additional biotherapeutic candidates in its Novel Biotherapeutics business. 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 biotherapeutic programs are early stage, highly regulated and expensive; the regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and the results inherently unpredictable; results of preclinical studies and early clinical trials of product candidates may not be predictive of results of later studies or trials; unintended or undesirable side effects of our product candidates could hinder or prevent receipt of regulatory approval; even if regulatory approval is obtained for any products that we develop alone or with collaborators, such products will remain subject to ongoing regulatory requirements and expenses; our biotherapeutic products may face competition in the market; 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

Financial Tables to Follow

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

Three months ended December 31, Twelve months ended December 31,
2018 2017 2018 2017
Revenues:
Product revenue $ 7,299 $ 7,551 $ 25,590 $ 26,685
Research and development revenue 8,769 14,171 35,004 23,339
Total revenues 16,068 21,722 60,594 50,024
Costs and operating expenses:
Cost of product revenue 2,393 3,559 12,620 14,327
Research and development 7,513 9,417 29,978 29,659
Selling, general and administrative 6,806 7,867 29,291 29,008
Total costs and operating expenses 16,712 20,843 71,889 72,994
Income (loss) from operations (644 ) 879 (11,295 ) (22,970 )
Interest income 227 52 671 147
Other expense, net (69 ) (12 ) (291 ) (92 )
Income (loss) before income taxes (486 ) 919 (10,915 ) (22,915 )
Provision for (benefit from) income taxes (25 ) (51 ) (37 ) 81
Net income (loss) $ (461 ) $ 970 $ (10,878 ) $ (22,996 )
Net income (loss) per share, basic $ (0.01 ) $ 0.02 $ (0.21 ) $ (0.50 )
Net income (loss) per share, diluted $ (0.01 ) $ 0.02 $ (0.21 ) $ (0.50 )
Weighted average common stock shares used in computing net income (loss) per share, basic 53,973 48,187 52,205 46,228
Weighted average common stock shares used in computing net income (loss) per share, diluted 53,973 50,599 52,205 46,228

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

December听31,
2018 2017
Assets
Current assets:
Cash and cash equivalents $ 53,039 $ 31,219
Accounts receivable, net 10,551 11,447
Unbilled receivables, current 1,916 353
Inventories, net 589 1,036
Prepaid expenses and other current assets 1,068 984
Contract assets 35
Total current assets 67,198 45,039
Restricted cash 1,446 1,557
Equity securities 588 671
Property and equipment, net 4,759 2,815
Goodwill 3,241 3,241
Other non-current assets 1,051 302
Total assets $ 78,283 $ 53,625
Liabilities and Stockholders鈥 Equity
Current liabilities:
Accounts payable $ 3,050 $ 3,545
Accrued compensation 5,272 4,753
Other accrued liabilities 4,855 4,362
Deferred revenues 3,936 12,292
Total current liabilities 17,113 24,952
Deferred revenues, net of current portion 3,352 1,501
Lease incentive obligation, net of current portion 35 460
Financing obligation, net of current portion 61 302
Other long-term liabilities 1,416 1,863
Total liabilities 21,977 29,078
Stockholders鈥 equity:
Common stock 5 5
Additional paid-in capital 386,775 340,079
Accumulated other comprehensive loss (472 )
Accumulated deficit (330,474 ) (315,065 )
Total stockholders鈥 equity 56,306 24,547
Total liabilities and stockholders鈥 equity $ 78,283 $ 53,625

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

Three months ended December 31, 2018 Three months ended December 31, 2017
Performance
Enzymes
Novel
Biotherapeutics
Total Performance
Enzymes
Novel
Biotherapeutics
Total
Revenues:
Product revenue $ 7,299 $ $ 7,299 $ 7,551 $ $ 7,551
Research and development revenue 5,755 3,014 8,769 6,480 7,691 14,171
Total revenues 13,054 3,014 16,068 14,031 7,691 21,722
Costs and operating expenses:
Cost of product revenue 2,392 2,392 3,559 3,559
Research and development(1) 4,376 2,891 7,267 4,265 4,973 9,238
Selling, general and administrative 1,843 156 1,999 2,133 2,133
Total segment costs and operating expenses 8,611 3,047 11,658 9,957 4,973 14,930
Income (loss) from operations $ 4,443 $ (33 ) 4,410 $ 4,074 $ 2,718 6,792
Corporate costs (2) (4,561 ) (5,626 )
Depreciation (335 ) (247 )
Loss before income taxes $ (486 ) $ 919

(1) Research and development expenses exclude depreciation.
(2) Corporate costs include unallocated selling, general and administrative expense, interest income, and other income and expenses.

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

Year Ended December 31, 2018 Year Ended December 31, 2017
Performance
Enzymes
Novel
Biotherapeutics
Total Performance
Enzymes
Novel
Biotherapeutics
Total
Revenues:
Product revenue $ 25,590 $ $ 25,590 $ 26,685 $ $ 26,685
Research and development revenue 21,483 13,521 35,004 15,648 7,691 23,339
Total revenues 47,073 13,521 60,594 42,333 7,691 50,024
Costs and operating expenses:
Cost of product revenue 12,620 12,620 14,327 14,327
Research and development(1) 18,924 10,185 29,109 16,847 12,107 28,954
Selling, general and administrative 7,538 771 8,309 7,371 7,371
Total segment costs and operating expenses 39,082 10,956 50,038 38,545 12,107 50,652
Income (loss) from operations $ 7,991 $ 2,565 10,556 $ 3,788 $ (4,416 ) (628 )
Corporate costs (2) (20,324 ) (21,245 )
Depreciation (1,147 ) (1,042 )
Loss before income taxes $ (10,915 ) $ (22,915 )

(1) Research and development expenses exclude depreciation.
(2) Corporate costs include unallocated selling, general and administrative expense, interest income, and other income and expenses.


五星体育直播听
Reconciliation of GAAP to Non-GAAP Financial Measures听
(unaudited)听
(In Thousands)

Three months ended December 31, Twelve months ended December 31,
2018 2017 2018 2017
(i) Research and development expenses
Research and development expenses - GAAP $ 7,513 $ 9,417 $ 29,978 $ 29,659
Non-GAAP adjustments:
Depreciation expense (a) (246 ) (178 ) (870 ) (709 )
Stock-based compensation (b) (500 ) (394 ) (2,055 ) (1,444 )
Research and development expenses - Non-GAAP $ 6,767 $ 8,845 $ 27,053 $ 27,506
听(ii) Selling, general and administrative expenses
Selling, general and administrative expenses - GAAP $ 6,806 $ 7,867 $ 29,291 $ 29,008
Non-GAAP adjustments:
Depreciation expense (a) (89 ) (69 ) (277 ) (333 )
Stock-based compensation (b) (1,182 ) (1,485 ) (5,834 ) (5,647 )
Selling, general and administrative expenses - Non-GAAP $ 5,535 $ 6,313 $ 23,180 $ 23,028
(iii) Net income (loss)
Net income (loss) - GAAP $ (461 ) $ 970 $ (10,878 ) $ (22,996 )
Non-GAAP adjustments:
Depreciation expense (a) 335 247 1,147 1,042
Employee stock-based compensation (b) 1,682 1,879 7,889 7,091
Net income (loss) - Non-GAAP $ 1,556 $ 3,096 $ (1,842 ) $ (14,863 )

五星体育直播听
Reconciliation of GAAP to Non-GAAP Financial Measures听
(unaudited)听
(Shares in Thousands)

Three months ended December 31, Twelve months ended December 31,
2018 2017 2018 2017
(iv) Net income (loss) per share
Net income (loss) per share - GAAP, basic $ (0.01 ) $ 0.02 $ (0.21 ) $ (0.50 )
Non-GAAP adjustments:
Depreciation expense (a) $ 0.01 $ 0.01 $ 0.02 $ 0.02
Stock-based compensation (b) $ 0.03 $ 0.04 $ 0.15 $ 0.15
Net income (loss) per share - Non-GAAP, basic $ 0.03 $ 0.06 $ (0.04 ) $ (0.32 )
Net income (loss) per share - GAAP, diluted $ (0.01 ) $ 0.02 $ (0.21 ) $ (0.50 )
Non-GAAP adjustments:
Depreciation expense (a) $ 0.01 $ $ 0.02 $ 0.02
Stock-based compensation (b) $ 0.03 $ 0.04 $ 0.15 $ 0.15
Net income (loss) per share - Non-GAAP, diluted $ 0.03 $ 0.06 $ (0.04 ) $ (0.32 )
Weighted average common shares used in computing GAAP and Non-GAAP net income (loss) per share, basic 53,973 48,187 52,205 46,228
Weighted average common shares used in computing GAAP net income (loss) per share, diluted 53,973 50,599 52,205 46,228
Effect of dilutive shares 4,469
Weighted average common shares used in computing non-GAAP net income (loss) per share, diluted 58,442 50,599 52,205 46,228

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: 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.

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