五星体育直播

Form: 8-K

Current report filing

November 5, 2019



Exhibit 99.1

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五星体育直播 Reports Third quarter 2019 Financial Results

Total revenues rose 29% to $21.9 million driven by strength in R&D, product, and CodeEvolver licensing revenues

Eleven customers each contributed at least a quarter million dollars in revenue

Conference call begins at 4:30 pm Eastern time today

REDWOOD CITY, Calif. (November听5, 2019) - 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, 2019 and provides a business update.

鈥淥ur exceptional financial performance for the third quarter featured total revenues up 29% to nearly $22 million. Strength was delivered across both product and R&D revenues, which increased 23% and 35%, respectively versus the prior year,鈥 said 五星体育直播 President and CEO John Nicols. 鈥淚mportantly, revenues were derived from a larger and increasingly diverse customer base, with seven customers each contributing more than $1 million, and another four each adding at least $250,000 in revenues in the quarter. Strong growth in revenues combined with careful expense management resulted in a profit for the quarter.

鈥淚n addition, the quarter benefitted from advancements with our CodeEvolver licensing strategy, starting with revenue from the Novartis agreement announced in May 2019. We also recognized revenue from a milestone payment from GlaxoSmithKline which marked the advancement of an enzyme developed under their agreement to practice our CodeEvolver protein engineering platform technology; the enzyme was engineered to potentially improve a key step in the manufacturing process for one of their active pharmaceutical ingredients.鈥

Third Quarter Financial Highlights
五星体育直播 is reporting two business segments: 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 2019 were $21.9 million, up 29% from $16.9 million for the third quarter of 2018. Product revenue was $10.4 million, up 23% from $8.4 million for the third quarter of 2018, with the increase reflecting customer demand for enzymes for both branded and generic pharmaceutical products. Research and development (R&D) revenue for the third quarter of 2019 was $11.6 million, up 35% from $8.5 million for the prior-year period. The increase was primarily due to revenues under the Novartis CodeEvolver Agreement and a milestone payment under the GSK CodeEvolver Agreement, partially offset by lower development fees from Nestl茅 Health Science. R&D revenue for the third quarter of 2019 included $10.1 million from the Performance Enzymes segment and $1.5 million from the Novel Biotherapeutics segment. R&D revenue for the third quarter of 2018 included $3.7 million from the Performance Enzymes segment, which included the completion of services to Tate & Lyle, and $4.8 million from the Novel Biotherapeutics segment.

Gross margin on product revenue for the third quarter of 2019 was 51%, compared with 55% for the third quarter of 2018, with the decrease due to product mix.

R&D expenses were $8.7 million for the third quarter of 2019, compared with $7.9 million for the third quarter of 2018, with the increase primarily due to headcount, allocation of occupancy-related costs and lab supplies, partially offset by lower outside services. R&D expenses for the third quarter of 2019 included $5.3 million from the

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Performance Enzymes segment and $3.1 million from the Novel Biotherapeutics segment. 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.

Selling, general and administrative (SG&A) expenses for the third quarter of 2019 were $7.9 million, compared with $7.3 million for the third quarter of 2018, with the increase primarily due to higher facilities costs and headcount, partially offset by reductions in outside services and allocable occupancy-related costs. SG&A expenses for the third quarter of 2019 included $2.0 million from the Performance Enzymes segment, $0.7 million from the Novel Biotherapeutics segment and the remaining portion is included in $5.4 million in corporate overhead and depreciation and amortization expense. SG&A expenses for the third quarter of 2018 included $1.9 million from the Performance Enzymes segment, $0.2 million from Novel Biotherapeutics and the remaining portion is included in $5.4 million in corporate overhead, depreciation, amortization and other expenses, net.

Net income for the third quarter of 2019 was $0.3 million, or $0.01 per diluted share, compared with a net loss for the third quarter of 2018 of $2.0 million, or $0.04 per share. Non-GAAP net income for the third quarter of 2019 was $2.5 million, or $0.04 per diluted share, compared with non-GAAP net income for the third quarter of 2018 of $91,000, or $0.00 per diluted 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, 2019 were $49.8 million, up 12% from $44.5 million for the nine months ended September 30, 2018, and included $24.6 million in product revenue and $25.2 million in R&D revenue. R&D revenue for the first nine months of 2019 included $16.5 million from the Performance Enzymes segment and $8.7 million from the Novel Biotherapeutics segment. 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.

Gross margin on product sales for the first nine months of 2019 was 50%, compared with 44% for the prior-year period, with the increase due to product mix.

R&D expenses for the first nine months of 2019 were $25.0 million, compared with $22.5 million for the first nine months of 2018, with the increase primarily due to headcount, allocation of occupancy-related costs and lab supplies, partially offset by decreases in stock-based compensation and outside services. R&D expenses for the first nine months of 2019 included $14.9 million from the Performance Enzymes segment and $9.3 million from the Novel Biotherapeutics segment. 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.

SG&A expenses for the first nine months of 2019 were $24.2 million, compared with $22.5 million for the first nine months of 2018, with the increase primarily due to higher facilities costs and headcount, partially offset by decreases in allocation of occupancy-related costs, stock-based compensation expense and outside services. SG&A expenses for the first nine months of 2019 included $6.5 million from the Performance Enzymes segment, $1.8 million from the Novel Biotherapeutics segment and the remaining portion is included in the $16.5 million in corporate overhead, depreciation, amortization and other expenses, net. SG&A expenses for the first nine months of 2018 included $5.7 million from Performance Enzymes, $0.6 million from the Novel Biotherapeutics segment and the remaining portion is included in the $16.6 million in corporate overhead, depreciation and amortization expense.

The net loss for the nine months ended September 30, 2019 was $11.3 million, or 0.20 per share, compared with a net loss for the nine months ended September 30, 2018 of $10.4 million, or $0.20 per share. Non-GAAP net loss for the first nine months of 2019 was $4.4 million, or $0.08 per share, compared with a non-GAAP net loss for the first nine months of 2018 of $3.4 million, or $0.07 per share.

Cash and cash equivalents as of September听30, 2019 were $92.1 million, compared with $53.0 million as of December听31, 2018.

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2019 Financial Outlook
五星体育直播 is affirming its financial guidance for 2019, as follows:
Total revenues are expected to be $69 million to $72 million;
Product revenues are expected to be $26 million to $29 million; and
Gross margin on product revenues 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 income or loss, non-GAAP net income or loss per share (basic and diluted), 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 8406309. A live webcast of the call will be available on the Investors section of www.codexis.com.

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 8406309 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 protein engineering company that applies its proprietary CodeEvolvertechnology 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 五星体育直播鈥 expectations regarding 2019 total revenues, product revenue and gross margin on product revenue. 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; potential adverse effects to 五星体育直播鈥 business if its customers鈥 products are not received well in the markets; 五星体育直播鈥 ability to

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deploy its technology platform in new market spaces; 五星体育直播鈥 dependence on key personnel; 五星体育直播鈥 ability to compete may decline if it loses some of its intellectual property rights; third party claims that 五星体育直播 infringes third party intellectual property rights; 五星体育直播 could face increased competition if third parties misappropriate 五星体育直播 biocatalysts; 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 biotherapeutic 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. 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, 2019 and Form 10-Q filed with the听SEC听辞苍听August 6, 2019, 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
jcain@lhai.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)




Three Months Ended September 30,
Nine months ended September 30,
2019
2018
2019
2018
Revenues:
Product revenue
$
10,351

$
8,405

$
24,588

$
18,291

Research and development revenue
11,555

8,541

25,220

26,235

Total revenues
21,906

16,946

49,808

44,526

Costs and operating expenses:
Cost of product revenue
5,067

3,791

12,230

10,228

Research and development
8,711

7,917

25,000

22,464

Selling, general and administrative
7,869

7,344

24,180

22,485

Total costs and operating expenses
21,647

19,052

61,410

55,177

Income (loss) from operations
259

(2,106
)
(11,602
)
(10,651
)
Interest income
480

199

929

444

Other expenses, net
(403
)
(80
)
(615
)
(221
)
Income (loss) before income taxes
336

(1,987
)
(11,288
)
(10,428
)
Provision for (benefit from) income taxes
(7
)
1

12

(11
)
Net income (loss)
$
343

$
(1,988
)
$
(11,300
)
$
(10,417
)
Net income (loss) per share, basic
$
0.01

$
(0.04
)
$
(0.20
)
$
(0.20
)
Net income (loss) per share, diluted
$
0.01

$
(0.04
)
$
(0.20
)
$
(0.20
)
Weighted average common stock shares used in computing net income (loss) per share, basic
58,287

53,597

55,818

51,609

Weighted average common stock shares used in computing net income (loss) per share, diluted
61,412

53,597

55,818

51,609




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五星体育直播
Condensed Consolidated Balance Sheets
(Unaudited)
(In Thousands)
September听30, 2019
December听31, 2018
Assets
Current assets:
Cash and cash equivalents
$
92,143

$
53,039

Accounts receivable, net
12,327

11,551

Unbilled receivables, current
2,317

1,916

Inventories
397

589

Prepaid expenses and other current assets
1,553

1,068

Contract assets
1,193

35

Total current assets
109,930

68,198

Restricted cash
1,731

1,446

Equity securities

588

Right-of-use assets - Operating leases, net
24,542


Right-of-use assets - Finance leases, net
321


Property and equipment, net
6,241

4,759

Goodwill
3,241

3,241

Other non-current assets
190

1,051

Total assets
$
146,196

$
79,283

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable
$
1,743

$
3,050

Accrued compensation
4,695

5,272

Other accrued liabilities
6,182

4,855

Current portion of lease obligations - Operating leases
893


Current portion of lease obligations - Finance leases
122


Deferred revenue
1,288

4,936

Total current liabilities
14,923

18,113

Deferred revenue, net of current portion
1,988

3,352

Long-term lease obligations - Operating leases
25,554


Long-term lease obligations - Finance leases

61

Lease incentive obligation, net of current portion

35

Other long-term liabilities
1,223

1,416

Total liabilities
43,688

22,977

Stockholders' equity:
Common stock
6

5

Additional paid-in capital
444,276

386,775

Accumulated deficit
(341,774
)
(330,474
)
Total stockholders' equity
102,508

56,306

Total liabilities and stockholders' equity
$
146,196

$
79,283



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五星体育直播
Segmented Information
(Unaudited)
(In Thousands)
Three months ended September 30, 2019
Three months ended September 30, 2018
Performance Enzymes
Novel Biotherapeutics
Total
Performance Enzymes
Novel Biotherapeutics
Total
Revenues:
Product revenue
$
10,351

$

$
10,351

$
8,405

$

$
8,405

Research and development revenue
10,073

1,482

11,555

3,720

4,821

8,541

Total revenues
20,424

1,482

21,906

12,125

4,821

16,946

Costs and operating expenses:
Cost of product revenue
5,067


5,067

3,791


3,791

Research and development (1)
5,313

3,080

8,393

4,758

2,920

7,678

Selling, general and administrative(1)
2,037

690

2,727

1,870

165

2,035

Total segment costs and operating expenses
12,417

3,770

16,187

10,419

3,085

13,504

Income (loss) from operations
$
8,007

$
(2,288
)
$
5,719

$
1,706

$
1,736

$
3,442

Corporate costs (2)
(4,912
)
(5,120
)
Depreciation and amortization
(471
)
(309
)
Income (loss) before income taxes
$
336

$
(1,987
)
(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 and expenses.

Nine months ended September 30, 2019
Nine months ended September 30, 2018
Performance Enzymes
Novel Biotherapeutics
Total
Performance Enzymes
Novel Biotherapeutics
Total
Revenues:
Product revenue
$
24,588

$

$
24,588

$
18,291

$

$
18,291

Research and development revenue
16,512

8,708

25,220

15,728

10,507

26,235

Total revenues
41,100

8,708

49,808

34,019

10,507

44,526

Costs and operating expenses:
Cost of product revenue
12,230


12,230

10,228


10,228

Research and development (1)
14,889

9,252

24,141

14,548

7,294

21,842

Selling, general and administrative(1)
6,499

1,768

8,267

5,695

615

6,310

Total segment costs and operating expenses
33,618

11,020

44,638

30,471

7,909

38,380

Income (loss) from operations
$
7,482

$
(2,312
)
$
5,170

$
3,548

$
2,598

$
6,146

Corporate costs (2)
(15,185
)
(15,762
)
Depreciation and amortization
(1,273
)
(812
)
Loss before income taxes
$
(11,288
)
$
(10,428
)
(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 and expenses.

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五星体育直播
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
(In Thousands, Except Per Share Amounts)
Three Months Ended September 30,
Nine Months Ended September 30,
2019
2018
2019
2018
(i) Research and development expenses
Research and development expenses - GAAP
$
8,711

$
7,917

$
25,000

$
22,464

Non-GAAP adjustments:
Depreciation expense(a)
(301
)
(239
)
(793
)
(623
)
Stock-based compensation(b)
(458
)
(552
)
(1,249
)
(1,555
)
Research and development expenses - Non-GAAP
$
7,952

$
7,126

22,958

20,286

(ii) Selling, general and administrative expenses
Selling, general and administrative expenses - GAAP
$
7,869

$
7,344

24,180

22,485

Non-GAAP adjustments:
Depreciation expense(a)
(125
)
(70
)
(325
)
(189
)
Stock-based compensation(b)
(1,274
)
(1,218
)
(4,534
)
(4,652
)
Selling, general and administrative expenses - Non-GAAP
$
6,470

$
6,056

19,321

17,644

(iii) Net Income (loss)
Net Income (loss) - GAAP
$
343

$
(1,988
)
$
(11,300
)
$
(10,417
)
Non-GAAP adjustments:
Depreciation expense(a)
426

309

1,118

812

Stock-based compensation(b)
1,732

1,770

5,783

6,207

Net Income (loss) - Non-GAAP
$
2,501

$
91

$
(4,399
)
$
(3,398
)
(iv) Net Income (loss) per share
Net Income (loss) per share - GAAP, basic
$
0.01

$
(0.04
)
$
(0.20
)
$
(0.20
)
Adjustments to GAAP net income (loss) per share (as detailed above)
0.03

0.04

0.12

0.13

Net income (loss) per share - Non-GAAP, basic
$
0.04

$

$
(0.08
)
$
(0.07
)
Net Income (loss) per share - GAAP, diluted
$
0.01

$
(0.04
)
$
(0.20
)
$
(0.20
)
Adjustments to GAAP net income (loss) per share (as detailed above)
0.03

0.04

0.12

0.13

Net income (loss) per share - Non-GAAP, diluted
$
0.04

$

$
(0.08
)
$
(0.07
)
Weighted average common shares used in computing GAAP and non-GAAP net income (loss) per share, basic
58,287

53,597

55,818

51,609

Weighted average common shares used in computing GAAP net income (loss) per share, basic
58,287

53,597

55,818

51,609

Effect of dilutive shares
3,125

4,415



Weighted average common shares used in computing non-GAAP net income (loss) per share, diluted
61,412

58,012

55,818

51,609


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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.
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