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EX-99.2 - EX-99.2 - ORASURE TECHNOLOGIES INCosur-ex992_206.htm
8-K - 8-K - ORASURE TECHNOLOGIES INCosur-8k_20200219.htm

Exhibit 99.1

 

 

 

Company Contacts:

 

Roberto Cuca

Jeanne Mell

Chief Financial Officer

610-882-1820

VP Corporate Communications

484-353-1575

Investorinfo@orasure.com

media@orasure.com

www.orasure.com

www.orasure.com

OraSure Announces 2019 Full Year and Fourth Quarter Financial Results

BETHLEHEM, PA – February 19, 2020 – (Globe Newswire) – OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices and microbiome laboratory and analytical services, today announced its financial results for the three months and year ended December 31, 2019.

Financial and Business Highlights

 

Net revenues for the fourth quarter of 2019 were $49.7 million, a 1% decrease from the fourth quarter of 2018. Net product revenues were $47.2 million, a 5% increase from the fourth quarter of 2018. Net product and service revenues in the fourth quarter of 2019 increased 12% over the comparable period of 2018 if revenues from the Company’s cryosurgical systems business, which was sold in 2019, are excluded from the year ago period.

 

Other revenue highlights include:

 

-

International sales of the Company’s OraQuick® HIV products increased 123% compared to the fourth quarter of 2018. This increase was primarily the result of higher sales of the Company’s OraQuick® HIV Self-Test.

 

-

Total microbiome product and service revenues in the fourth quarter of 2019 were $4.4 million compared to $1.9 million in the fourth quarter of 2018. Microbiome revenues in 2019 include the service revenues generated by the Company’s subsidiaries, CoreBiome, Inc. and Diversigen, Inc.

 

-

Total molecular collection systems revenues including royalty income and other revenues were $27.8 million during the fourth quarter of 2019, a decline of 8% from the fourth quarter of 2018. Molecular collection systems product and service revenues were $25.5 million during the fourth quarter of 2019, and were flat compared to the fourth quarter of 2018.

 

Net income for the fourth quarter of 2019 was $2.4 million, or $0.04 per share on a fully-diluted basis, compared to net income of $10.3 million, or $0.16 per share on a fully-diluted basis, for the fourth quarter of 2018. Net income for the fourth quarter of 2019 included $797,000 of acquisition-related transaction costs and a non-cash charge of $179,000 representing the change


 

in fair value of contingent consideration associated with two acquisitions that closed at the beginning of the year. The net impact of the additional transaction costs and the change in the fair value of contingent consideration in the current quarter was approximately $0.02 per share on a fully-diluted basis. Net income for the fourth quarter of 2018 included $1.2 million of expense for activities in support of the early January 2019 acquisitions and $974,000 of transition costs associated with the Company’s executive management changes during that period.  The transaction and transition costs together represent $0.04 per share for the fourth quarter of 2018. The transition costs in the fourth quarter consisted of non-cash stock compensation charges.

 

Cash and investments totaled $189.8 million at December 31, 2019.

 

“We had a strong close to 2019. Our fourth quarter revenue performance was primarily driven by triple-digit growth in our international HIV sales and an impressive showing by our microbiome product and services business,” said OraSure President and CEO, Stephen S. Tang. “Through our acquisitions and investment in our core businesses, we have built on our leadership in sample collection and infectious disease diagnostics and bolstered our services capabilities in the burgeoning field of microbiome analysis.  In 2020, we expect to increase our investment in these core areas to provide our customers with the information and data they need to understand health, wellness and disease states.  Looking further ahead, we believe these activities will empower us to advance our innovation strategy at an ever faster rate.”

Financial Results

Net product and service revenues for the fourth quarter of 2019 increased 5% from the comparable period of 2018, primarily as a result of higher international HIV product sales and higher sales of the Company’s microbiome products and services. The increased sales were partially offset by the absence of cryosurgical sales in the quarter, as the cryosurgical systems business was divested in mid-August, and by lower genomics product sales.

 

International sales of the OraQuick® HIV Self-Test for the three months ended December 31, 2019 and 2018 included $966,000 and $855,000, respectively, of support payments under the Company’s charitable support agreement with the Bill & Melinda Gates Foundation.

Royalty income from a litigation settlement associated with a molecular collection device was $2.2 million and $4.8 million for the fourth quarter of 2019 and 2018, respectively. Other revenues were $334,000 and $578,000 for the fourth quarter of 2019 and 2018, respectively.

Gross profit percentage was 60% and 69% for the three months ended December 31, 2019 and 2018, respectively.  Gross profit percentage in 2019 was negatively affected by a less favorable product mix as a result of higher sales of lower gross profit products and services and the decline in other revenues.

For the three months ended December 31, 2019, operating expenses were $25.8 million, an increase of $3.6 million from the $22.2 million reported for the three months ended December 31, 2018. This increase was due primarily to the contribution of $2.0 million of operating expenses incurred by our newly acquired subsidiaries, higher research and development costs associated with the development of automated drug testing assays, and increased professional fees associated with business development work including $797,000 associated with the Diversigen acquisition, partially offset by a decline in employee bonus accruals and stock compensation expense, the amount of which is directly related to Company and individual performance. Fourth quarter 2018 operating expenses included $1.2 million of transaction costs associated with the Company’s acquisitions of CoreBiome and Novosanis.

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The Company generated operating income of $4.1 million in the fourth quarter of 2019 compared to operating income of $12.5 million in the fourth quarter of 2018.

During the fourth quarter of 2019, the Company recorded income tax expense of $2.1 million compared to $3.8 million recorded in the fourth quarter of 2018. This decrease largely reflects the lower pre-tax income generated by the Company’s Canadian subsidiary.

The Company’s cash and investment balance totaled $189.8 million at December 31, 2019, compared to $201.3 million at December 31, 2018. For the year ended December 31, 2019, the Company generated $9.8 million in cash from operations compared with $39.1 million in the same period of 2018.

Full-Year 2020 Guidance

The Company expects consolidated net revenues for the year ended December 31, 2020 to range from $145.0 million to $155.0 million and is projecting a net loss of $0.07 to $0.10 per share.  These projections do not account for the impact of changes in the fair value of acquisition-related contingent consideration or any potential transaction costs related to future business development activity since those items cannot be fully determined at this time. “We expect 2020 to be a building year for the OraSure family of companies as we focus on revenue growth by continuing to invest in our core businesses and leveraging our balance sheet to accelerate our innovation growth strategy,” added Dr. Tang.  


3

 


Financial Data

Condensed Consolidated Financial Data

(in thousands, except per-share data)

 

(Unaudited)

 

 

Three Months Ended

 

 

 

Year Ended

 

 

 

December 31,

 

 

 

December 31,

 

 

 

2019

 

 

2018

 

 

 

2019

 

 

2018

 

Results of Operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenues

 

$

49,668

 

 

$

50,246

 

 

 

$

154,605

 

 

$

181,743

 

Cost of products sold

 

 

19,829

 

 

 

15,540

 

 

 

 

60,022

 

 

 

68,130

 

Gross profit

 

 

29,839

 

 

 

34,706

 

 

 

 

94,583

 

 

 

113,613

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

6,104

 

 

 

4,059

 

 

 

 

19,629

 

 

 

16,250

 

Sales and marketing

 

 

7,932

 

 

 

8,377

 

 

 

 

31,869

 

 

 

30,609

 

General and administrative

 

 

11,539

 

 

 

9,758

 

 

 

 

35,287

 

 

 

38,325

 

Change in fair value of acquisition-related contingent consideration

 

 

179

 

 

 

 

 

 

 

(664

)

 

 

 

Gain on sale of business

 

 

 

 

 

 

 

 

 

(10,149

)

 

 

 

Total operating expenses

 

 

25,754

 

 

 

22,194

 

 

 

 

75,972

 

 

 

85,184

 

Operating income

 

 

4,085

 

 

 

12,512

 

 

 

 

18,611

 

 

 

28,429

 

Other income

 

 

477

 

 

 

1,629

 

 

 

 

2,720

 

 

 

3,287

 

Income before income taxes

 

 

4,562

 

 

 

14,141

 

 

 

 

21,331

 

 

 

31,716

 

Income tax expense

 

 

2,124

 

 

 

3,843

 

 

 

 

4,675

 

 

 

11,320

 

Net income

 

$

2,438

 

 

$

10,298

 

 

 

$

16,656

 

 

$

20,396

 

Earnings per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.04

 

 

$

0.17

 

 

 

$

0.27

 

 

$

0.33

 

Diluted

 

$

0.04

 

 

$

0.16

 

 

 

$

0.27

 

 

$

0.33

 

Weighted average shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

61,729

 

 

 

61,268

 

 

 

 

61,675

 

 

 

61,112

 

Diluted

 

 

62,199

 

 

 

62,511

 

 

 

 

62,170

 

 

 

62,532

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4

 


Summary of Net Revenues by Market and Product (Unaudited)

 

 

Three Months Ended December 31,

 

 

 

 

Dollars

 

 

 

 

 

 

 

Percentage of Total Net Revenues

 

 

 

 

2019

 

 

2018

 

 

%

Change

 

 

 

2019

 

 

 

2018

 

 

Market

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Infectious disease testing

 

$

18,743

 

 

$

13,643

 

 

 

37

 

%

 

 

38

 

%

 

 

27

 

%

Risk assessment testing

 

 

2,944

 

 

 

2,898

 

 

 

2

 

 

 

 

6

 

 

 

 

6

 

 

Cryosurgical systems

 

 

 

 

 

2,894

 

 

 

(100

)

 

 

 

 

 

 

 

6

 

 

Molecular collection systems

 

 

25,487

 

 

 

25,407

 

 

 

 

 

 

 

51

 

 

 

 

50

 

 

Net product and service revenues

 

 

47,174

 

 

 

44,842

 

 

 

5

 

 

 

 

95

 

 

 

 

89

 

 

Royalty income

 

 

2,160

 

 

 

4,826

 

 

 

(55

)

 

 

 

4

 

 

 

 

10

 

 

Other

 

 

334

 

 

 

578

 

 

 

(42

)

 

 

 

1

 

 

 

 

1

 

 

Net revenues

 

$

49,668

 

 

$

50,246

 

 

 

(1

)

%

 

 

100

 

%

 

 

100

 

%

 

 

Year Ended December 31,

 

 

 

 

Dollars

 

 

 

 

 

 

 

Percentage of Total Net Revenues

 

 

 

 

2019

 

 

2018

 

 

%

Change

 

 

 

2019

 

 

 

2018

 

 

Market

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Infectious disease testing

 

$

58,016

 

 

$

56,148

 

 

 

3

 

%

 

 

38

 

%

 

 

31

 

%

Risk assessment testing

 

 

12,189

 

 

 

12,058

 

 

 

1

 

 

 

 

8

 

 

 

 

7

 

 

Cryosurgical systems

 

 

7,054

 

 

 

10,767

 

 

 

(34

)

 

 

 

5

 

 

 

 

6

 

 

Molecular collection systems

 

 

70,814

 

 

 

86,455

 

 

 

(18

)

 

 

 

45

 

 

 

 

47

 

 

Net product and service revenues

 

 

148,073

 

 

 

165,428

 

 

 

(10

)

 

 

 

96

 

 

 

 

91

 

 

Royalty income

 

 

5,116

 

 

 

9,653

 

 

 

(47

)

 

 

 

3

 

 

 

 

5

 

 

Other

 

 

1,416

 

 

 

6,662

 

 

 

(79

)

 

 

 

1

 

 

 

 

4

 

 

Net revenues

 

$

154,605

 

 

$

181,743

 

 

 

(15

)

%

 

 

100

 

%

 

 

100

 

%

 

 

Three Months Ended

 

 

 

Year Ended

 

 

 

 

December 31,

 

 

 

December 31,

 

 

 

 

2019

 

 

2018

 

 

%

Change

 

 

 

2019

 

 

2018

 

 

%

Change

 

 

OraQuick® Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Domestic HIV

 

$

4,960

 

 

$

4,974

 

 

 

 

%

 

$

17,984

 

 

$

19,663

 

 

 

(9

)

%

International HIV

 

 

9,795

 

 

 

4,399

 

 

 

123

 

 

 

 

25,108

 

 

 

21,794

 

 

 

15

 

 

Net HIV revenues

 

 

14,755

 

 

 

9,373

 

 

 

57

 

 

 

 

43,092

 

 

 

41,457

 

 

 

4

 

 

Domestic HCV

 

 

2,202

 

 

 

2,066

 

 

 

7

 

 

 

 

8,108

 

 

 

7,490

 

 

 

8

 

 

International HCV

 

 

1,295

 

 

 

1,598

 

 

 

(19

)

 

 

 

4,864

 

 

 

4,904

 

 

 

(1

)

 

Net HCV revenues

 

 

3,497

 

 

 

3,664

 

 

 

(5

)

 

 

 

12,972

 

 

 

12,394

 

 

 

5

 

 

Net product revenues

 

$

18,252

 

 

$

13,037

 

 

 

40

 

%

 

$

56,064

 

 

$

53,851

 

 

 

4

 

%

5

 


 

 

Three Months Ended

 

 

 

Year Ended

 

 

 

 

December 31,

 

 

 

December 31,

 

 

 

 

2019

 

 

2018

 

 

%

Change

 

 

 

2019

 

 

2018

 

 

%

Change

 

 

Molecular Collection Systems Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Genomics

 

$

21,005

 

 

$

23,505

 

 

 

(11

)

%

 

$

57,365

 

 

$

79,765

 

 

 

(28

)

%

Microbiome

 

 

4,423

 

 

 

1,902

 

 

 

133

 

 

 

 

12,786

 

 

 

6,690

 

 

 

91

 

 

Other

 

 

59

 

 

 

 

 

 

100

 

 

 

 

663

 

 

 

 

 

 

100

 

 

Net product and service revenues

 

 

25,487

 

 

 

25,407

 

 

 

 

 

 

 

70,814

 

 

$

86,455

 

 

 

(18

)

 

Royalty income

 

 

2,160

 

 

 

4,826

 

 

 

(55

)

 

 

 

5,116

 

 

 

9,653

 

 

 

(47

)

 

Other

 

 

129

 

 

 

 

 

 

100

 

 

 

 

450

 

 

 

 

 

 

100

 

 

Net revenues

 

$

27,776

 

 

$

30,233

 

 

 

(8

)

%

 

$

76,380

 

 

$

96,108

 

 

 

(21

)

%

 

 

Condensed Consolidated Balance Sheets (Unaudited)

 

 

December 31, 2019

 

 

December 31, 2018

 

Assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

75,715

 

 

$

88,438

 

Short-term investments

 

 

80,623

 

 

 

68,134

 

Accounts receivable, net

 

 

36,948

 

 

 

34,842

 

Inventories

 

 

23,155

 

 

 

22,888

 

Other current assets

 

 

8,109

 

 

 

5,010

 

Property, plant and equipment, net

 

 

30,339

 

 

 

24,299

 

Right of use assets, net

 

 

6,947

 

 

 

 

Intangible assets, net

 

 

14,674

 

 

 

5,137

 

Goodwill

 

 

36,201

 

 

 

18,521

 

Long-term investments

 

 

33,420

 

 

 

44,752

 

Other non-current assets

 

 

3,164

 

 

 

3,550

 

Total assets

 

$

349,295

 

 

$

315,571

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Accounts payable

 

$

9,567

 

 

$

10,598

 

Deferred revenue

 

 

3,713

 

 

 

3,521

 

Contingent consideration obligation

 

 

3,500

 

 

 

 

Other current liabilities

 

 

15,933

 

 

 

13,861

 

Long-term lease liabilities

 

 

5,578

 

 

 

 

Other non-current liabilities

 

 

3,859

 

 

 

4,213

 

Stockholders’ equity

 

 

307,145

 

 

 

283,378

 

Total liabilities and stockholders’ equity

 

$

349,295

 

 

$

315,571

 

 

Additional Financial Data (Unaudited)

 

Year Ended

 

 

 

December 31,

 

 

 

2019

 

 

2018

 

Capital expenditures

 

$

9,314

 

 

$

6,344

 

Depreciation and amortization

 

$

7,730

 

 

$

7,222

 

Stock-based compensation

 

$

4,057

 

 

$

15,237

 

Cash provided by operating activities

 

$

9,804

 

 

$

39,090

 

6

 


 

Conference Call

The Company will host a conference call and audio webcast for analysts and investors to discuss the Company’s 2019 fourth quarter results, certain business developments and updated financial guidance, beginning today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will be Dr. Stephen S. Tang, President and Chief Executive Officer, and Roberto Cuca, Chief Financial Officer. The call will include prepared remarks by management and a question and answer session.

 

In order to listen to the conference call, please dial 844-831-3030 (Domestic) or 315-625-6887 (International) and reference Conference ID #5381869 or go to OraSure Technologies’ web site, www.orasure.com, and click on the Investor Relations page. Please click on the webcast link and follow the prompts for registration and access 10 minutes prior to the call. A replay of the call will be archived on OraSure Technologies’ web site shortly after the call has ended and will be available for seven days. A replay of the call can also be accessed until midnight, February 26, 2020, by dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and entering the Conference ID #5381869.

About OraSure Technologies

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate essential information.  Together with its wholly-owned subsidiaries (DNA Genotek, CoreBiome, Diversigen and Novosanis), OraSure provides its customers with end-to-end solutions that encompass tools, services and diagnostics.  The OraSure family of companies is a leader in the development, manufacture and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular product and services solutions designed to discover and detect critical medical conditions.  OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, distributors, government agencies, pharma, commercial entities and direct to consumers.

 

For more information on OraSure Technologies, please visit www.orasure.com.

 

Important Information

This press release contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: ability to successfully manage and integrate acquisitions of other companies in a manner that complements or leverages our existing business, or otherwise expands or enhances our portfolio of products and our end-to-end service offerings, and the diversion of management’s attention from our ongoing business and regular business responsibilities to effect such integration; the expected economic benefits of acquisitions (and increased returns for our stockholders), including that the anticipated synergies, revenue enhancement strategies and other benefits from the acquisitions may not be fully realized or may take longer to realize than expected and our actual integration costs may exceed our estimates; impact of increased or different risks arising from the acquisition of companies located in foreign countries; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to

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effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration (“FDA”) or other regulators; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for the Company’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales; ability to identify, complete, integrate and realize the full benefits of future acquisitions; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention (“CDC”) or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors that could affect our results are discussed more fully in our Securities and Exchange Commission (“SEC”) filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2018, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements.  The forward-looking statements are made as of the date of this press release and we undertake no duty to update these statements.

#   #   #  

 

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