8-K
0001116463false00011164632023-02-142023-02-14

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): February 14, 2023

OraSure Technologies, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware

 

001-16537

 

36-4370966

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

220 East First Street

 

Bethlehem, Pennsylvania

18015-1360

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: 610-882-1820

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.000001 par value per share

 

OSUR

 

The NASDAQ Stock Market LLC

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by a check mark whether the Registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

1

 


Item 2.02 – Results of Operations and Financial Condition.

On February 14, 2023, OraSure Technologies, Inc. (the “Company”) issued a press release announcing its consolidated financial results for full year and quarter ended December 31, 2022 and certain other matters. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

The information in this Item and attached Exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall such information and Exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such a filing. The fact that the information and Exhibit are being furnished should not be deemed an admission as to the materiality of any information contained therein. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Current Report or attached Exhibit.

Item 7.01 – Regulation FD Disclosure.

On February 14, 2023, the Company held a webcast conference call with analysts and investors, during which members of the Company’s management team, including Carrie Eglinton Manner, the Company’s President and Chief Executive Officer, and Kenneth J. McGrath, the Company’s Chief Financial Officer, discussed the Company’s consolidated financial results for the full year and quarter ended December 31, 2022, and described certain business developments.

The information in this Item shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall such information and Exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such a filing. The fact that the information is being furnished should not be deemed an admission as to the materiality of any information contained therein. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Current Report.

Item 8.01 – Other Events

On February 14, 2023, the Company announced a business restructuring to combine its Molecular Solutions and Diagnostics business units resulting in the elimination of roles impacting approximately 11% of its current non-production workforce. These actions are part of the Company’s efforts toward achieving cashflow breakeven for its core business.

Item 9.01 – Financial Statements and Exhibits.

(d) Exhibits

 

 

 

 

Exhibit

Number

 

Description

 

 

99.1

 

Press Release, dated February 14, 2023, announcing consolidated financial results of OraSure Technologies, Inc. for the full-year and quarter ended December 31, 2022 and certain other matters.

 

 

 

Exhibit 104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

2

 


 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

ORASURE TECHNOLOGIES, INC.

 

 

Date: February 14, 2023

By:

/s/ Carrie Eglinton Manner

 

 

Carrie Eglinton Manner

 

 

President and Chief Executive Officer

 

 

 

3

 


EX-99

 

https://cdn.kscope.io/494820f99bbe28e22041e9afca4d474e-img105834308_0.jpg 

EXHIBIT 99.1

 

Investor Contact:

Scott Gleason

SVP investor Relations & Corporate Communications

(484) 425-0588

sgleason@orasure.com

Media Contact:

Amy Koch

Sr. Manager Corporate Communications

(484) 523-1815

media@orasure.com

 

OraSure Reports 4Q22 Record Revenue of $123.1 Million Growing 94% Year-Over-Year;

Positions for Longer-Term Growth and Profitability

InteliSwab® revenue of $88.9 million in Q4, up 12% sequentially; wins two new federal government contracts extending the tail on InteliSwab® revenue

 

Signs a deal with Quest Diagnostics Genomic Sequencing Services for saliva collection kits

Q4 GAAP EPS of $0.21; Non-GAAP EPS of $0.36

Announces restructuring expected to result in operating expense savings of $15 million to be fully implemented by June 2023; targets achieving cash flow breakeven for core business by end of 2024

Cash balance grows to $111 million, up $9 million from prior quarter

Management to Host Analyst/Investor Call and Webcast Today at 5:00 p.m. ET

BETHLEHEM, PA, February 14, 2023 (GLOBE NEWSWIRE) – OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care and home diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its financial results for the three months ended December 31, 2022.

 

“This quarter we have delivered clear progress on our transformation journey to Strengthen our foundation. We identified meaningful expense reductions through restructuring our two business units into a single organization, reducing our non-production workforce by 11%, and lowering manufacturing costs. Importantly, this quarter we further increased our cash balance that will help fund investments for our future,” said OraSure President and CEO Carrie Eglinton Manner.

 

She continued, “building from our stronger base, our focus this year is to increasingly Elevate core growth across our product lines by expanding our existing business, driving internal innovation, and targeting key strategic partnerships. We believe our actions will drive the Company to achieving cash flow breakeven for the core business by the end of 2024 while we Accelerate profitable growth.”

 

 

1

 


 

Financial Highlights

 

Three Months Ended

 

 

 

Year Ended

 

 

 

December 31,

 

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

% Change

 

 

 

2022

 

 

2021

 

 

% Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Core Diagnostics

$

18,400

 

 

$

17,898

 

 

 

3

 

%

 

$

70,007

 

 

$

67,333

 

 

 

4

 

%

InteliSwab

 

88,857

 

 

 

14,770

 

 

 

502

 

 

 

 

233,666

 

 

 

22,707

 

 

 

929

 

 

Total Diagnostics

 

107,257

 

 

 

32,668

 

 

 

228

 

 

 

 

303,673

 

 

 

90,040

 

 

 

237

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Core Molecular Solutions

 

15,684

 

 

 

22,936

 

 

 

(32

)

 

 

 

74,147

 

 

 

89,467

 

 

 

(17

)

 

COVID-19 kits

 

137

 

 

 

7,964

 

 

 

(98

)

 

 

 

9,659

 

 

 

54,167

 

 

 

(82

)

 

Total Molecular Solutions

 

15,821

 

 

 

30,900

 

 

 

(49

)

 

 

 

83,806

 

 

 

143,634

 

 

 

(42

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Revenue

$

123,078

 

 

$

63,568

 

 

 

94

 

%

 

$

387,479

 

 

$

233,674

 

 

 

66

 

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

Year ended

 

 

 

December 31,

 

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

% Change

 

 

 

2022

 

 

2021

 

 

% Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenues

$

123,078

 

 

$

63,568

 

 

 

94

 

%

 

$

387,479

 

 

$

233,674

 

 

 

66

 

%

Gross profit

 

49,589

 

 

 

27,133

 

 

 

83

 

 

 

 

147,637

 

 

 

117,600

 

 

 

26

 

 

Gross margin

 

40

%

 

 

43

%

 

 

 

 

 

 

38

%

 

 

50

%

 

 

 

 

Non-GAAP gross profit

 

50,126

 

 

 

28,685

 

 

 

75

 

 

 

 

154,464

 

 

 

121,708

 

 

 

27

 

 

Non-GAAP gross margin

 

41

%

 

 

45

%

 

 

 

 

 

 

40

%

 

 

52

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income (loss)

 

13,435

 

 

 

(9,371

)

 

NM

 

 

 

 

(22,957

)

 

 

(10,164

)

 

NM

 

 

Operating margin

 

11

%

 

 

-15

%

 

 

 

 

 

 

-6

%

 

 

-4

%

 

 

 

 

Non-GAAP operating income (loss)

 

18,340

 

 

 

(1,336

)

 

NM

 

 

 

 

21,726

 

 

 

5,388

 

 

 

303

 

 

Non-GAAP operating income (loss)

 

15

%

 

 

-2

%

 

 

 

 

 

 

6

%

 

 

2

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

15,561

 

 

 

(10,393

)

 

NM

 

 

 

 

(17,935

)

 

 

(22,998

)

 

 

-22

 

 

Non-GAAP net income (loss)

 

26,041

 

 

 

(2,490

)

 

NM

 

 

 

 

24,986

 

 

 

(7,847

)

 

 

(418

)

 

GAAP EPS

$

0.21

 

 

$

(0.14

)

 

NM

 

 

 

$

(0.25

)

 

$

(0.32

)

 

 

(23

)

 

Non-GAAP EPS

$

0.36

 

 

$

(0.03

)

 

NM

 

%

 

$

0.34

 

 

$

(0.11

)

 

 

(416

)

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NM – not meaningful

 

Net revenues for the fourth quarter of 2022 were $123.1 million, a 94% increase from the fourth quarter of 2021 and a new record for the Company.
Total InteliSwab® test revenue of $88.9 million increased 12% sequentially as the Company continued to scale its production capacity and saw increased order volume supporting the Federal government’s school testing program.
Core Diagnostic revenue increased 3% versus the prior year primarily due to strong domestic growth in HIV and HCV product sales. The Company experienced delays of a large number of international diagnostic orders toward the end of the quarter due to timing of product availability which we believe will drive higher sales in the first quarter of 2023. Core Molecular Solutions revenue decreased 32% year-over-year predominantly due to lower order volumes at key customers. The Company believes that some of this decline is associated with customer destocking activity as many organizations focus on cash balances given challenging financial conditions.

2

 


 

GAAP gross margin percentage was 40.3% in the quarter compared to 42.7% in the fourth quarter of 2021. GAAP gross margins increased 60 basis points on a sequential basis. Non-GAAP gross margins in the quarter were 40.7% compared to 45.1% in the fourth quarter of 2021 and Non-GAAP gross margins increased 70 basis points on a sequential basis. On a year-over-year basis, gross margins were negatively impacted primarily by product mix, but improved sequentially with efficiencies achieved with the Company’s InteliSwab® test production.
GAAP operating income in the fourth quarter was $13.4 million which compares to a ($9.4) million operating loss in the fourth quarter of 2021 and increased $12.6 million on a sequential basis. Non-GAAP operating income was $18.3 million in the quarter compared to a ($1.3) million operating loss in the fourth quarter of 2021 and increased by $7.0 million on a sequential basis. This was driven by higher revenue, improved gross margins, and lower non-GAAP operating expenses which declined by $3.5 million sequentially due to timing and cost control.
Cash and short-term investments increased $9.2M sequentially to $110.8 million in Q4 2022. Working capital increased significantly in the fourth quarter, which the Company believes will convert to cash as InteliSwab® revenues begin to taper in the future.

 

Business Restructuring

 

The Company has shared a business restructuring combining its Molecular Solutions and Diagnostics business units into One OraSure. As part of the restructuring, the Company is announcing role eliminations that will affect 11% of its current non-production workforce. The Company believes that, when coupled with additional cost savings, these changes will lead to annualized operating expense reductions of approximately $15 million to be fully implemented by the end of the second quarter of 2023. With additional system changes and manufacturing site consolidation, the Company targets achieving cash flow breakeven on base business (excluding InteliSwab® revenue) by the end of calendar year 2024. The Company’s profitability turnaround enables current cash generation from InteliSwab® to be utilized for innovation and future growth investments.

 

“To support our long-term goals and growth as an organization, we’ve made the difficult decision to eliminate a number of roles,” said OraSure President and CEO Carrie Eglinton Manner. “The changes we made will streamline levels of leadership, centralize core enterprise functions, and prioritize value creation activities. We believe our new operating structure will unlock significant operating efficiencies, foster stronger collaboration across the organization, and allow us to increase our innovation pipeline for growth.”

 

Recent Business Highlights

 

Signed a deal with Quest Diagnostics to serve as the preferred provider of saliva collection kits for Quest’s Genomic Sequencing Services Group’s test offerings.
Received FDA approval for a new packaging and labeling configuration for InteliSwab®. The Company expects the new configuration to begin shipping by the end of March 2023. The packaging changes are expected to drive per test cost savings of approximately $0.40 which includes the impact from lower shipping costs based upon the smaller packaging configuration which should reduce total truckloads by approximately 50%.
Launched four new CE-IVD Collipee urine collection products to support growing interest in non-invasive HPV and STI screening diagnostics and liquid biopsy from first-void urine samples. Included among these launches is a product with a proprietary chemistry for cell-free DNA and extra-cellular vesicles for oncology applications.
Announced two new federal government contracts for InteliSwab®. The first procurement contract runs through November 2023; and, under the terms of the award, the contract estimate is 18 million

3

 


 

InteliSwab® COVID-19 Rapid Tests, with a maximum award of 36 million tests and a guaranteed minimum award of 3.6 million tests. The second contract was awarded for 3.2 million tests in December of 2022.
Chosen as one of a group of manufacturers to win a Connecticut tender that allows the Company to compete for a total award of six million potential InteliSwab® tests annually.
Evaluating new respiratory applications to build upon our COVID-19 success, including internally and externally via strategic partnership.
Pursuing additional 510(k) clearances for the use of our proprietary collection kits in new applications in women’s health and oncology, similar to our recently announced co-clearance with Grifols.
Announced that its OraQuick HIV® Self-Test, in addition to its InteliSwab® test, is available for purchase directly via Amazon with eligibility for Prime free shipping.
Noted that the first microbiome based therapeutic received FDA approval which the Company views as a signal of positive catalyst for investment in the microbiome testing services industry.

 

Financial Guidance

 

The Company is guiding toward 1Q23 revenue of $125 to $130 million representing 85% to 92% growth relative to the first quarter of last year. Given the continued volatility with the COVID-19 market, OraSure is only providing quarterly financial guidance for fiscal year 2023; however, it is anticipating higher revenue in the first half of the year followed by lower sales in the second half as the Company works down its COVID-19 government contracts.

 

 

4

 


 

Financial Data (Unaudited)

 

 

Three Months Ended

 

 

Year Ended

 

 

 

December 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Results of Operations

 

 

 

 

 

 

 

 

 

 

 

 

Net revenues

 

$

123,078

 

 

$

63,568

 

 

$

387,479

 

 

$

233,674

 

Cost of products and services sold

 

 

73,489

 

 

 

36,435

 

 

 

239,842

 

 

 

116,074

 

Gross profit

 

 

49,589

 

 

 

27,133

 

 

 

147,637

 

 

 

117,600

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

8,999

 

 

 

8,900

 

 

 

36,237

 

 

 

34,170

 

Sales and marketing

 

 

11,363

 

 

 

10,915

 

 

 

49,238

 

 

 

44,751

 

General and administrative

 

 

15,944

 

 

 

16,648

 

 

 

68,206

 

 

 

50,328

 

Loss on impairment

 

 

 

 

 

 

 

 

17,101

 

 

 

 

Change in fair value of acquisition-related contingent consideration

 

 

(152

)

 

 

41

 

 

 

(188

)

 

 

(1,485

)

Total operating expenses

 

 

36,154

 

 

 

36,504

 

 

 

170,594

 

 

 

127,764

 

Operating income (loss)

 

 

13,435

 

 

 

(9,371

)

 

 

(22,957

)

 

 

(10,164

)

Other income

 

 

1,960

 

 

 

443

 

 

 

6,480

 

 

 

872

 

Income (loss) before income taxes

 

 

15,395

 

 

 

(8,928

)

 

 

(16,477

)

 

 

(9,292

)

Income tax expense (benefit)

 

 

(166

)

 

 

1,465

 

 

 

1,458

 

 

 

13,706

 

Net income (loss)

 

$

15,561

 

 

$

(10,393

)

 

$

(17,935

)

 

$

(22,998

)

Earnings (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.21

 

 

$

(0.14

)

 

$

(0.25

)

 

$

(0.32

)

Diluted

 

$

0.21

 

 

$

(0.14

)

 

$

(0.25

)

 

$

(0.32

)

Weighted average shares:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

72,734

 

 

 

72,040

 

 

 

72,505

 

 

 

71,981

 

Diluted

 

 

73,248

 

 

 

72,040

 

 

 

72,505

 

 

 

71,981

 

 

 

5

 


 

 

Three Months Ended

 

 

 

Year Ended

 

 

 

December 31,

 

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

% Change

 

 

 

2022

 

 

2021

 

 

% Change

 

 

DIAGNOSTICS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  Infectious Disease Testing Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Domestic HIV

$

4,126

 

 

$

3,773

 

 

 

9

 

%

 

$

16,241

 

 

$

16,641

 

 

 

(2

)

%

     International HIV

 

7,109

 

 

 

8,626

 

 

 

(18

)

 

 

 

22,571

 

 

 

25,503

 

 

 

(11

)

 

 Net HIV revenues

 

11,235

 

 

 

12,399

 

 

 

(9

)

 

 

 

38,812

 

 

 

42,144

 

 

 

(8

)

 

     Domestic HCV

 

1,913

 

 

 

1,301

 

 

 

47

 

 

 

 

8,353

 

 

 

6,881

 

 

 

21

 

 

     International HCV

 

1,274

 

 

 

1,100

 

 

 

16

 

 

 

 

5,016

 

 

 

4,902

 

 

 

2

 

 

 Net HCV revenues

 

3,187

 

 

 

2,401

 

 

 

33

 

 

 

 

13,369

 

 

 

11,783

 

 

 

13

 

 

            Net OraQuick® revenues

 

14,422

 

 

 

14,800

 

 

 

(3

)

 

 

 

52,181

 

 

 

53,927

 

 

 

(3

)

 

     COVID-19

 

88,857

 

 

 

14,770

 

 

 

502

 

 

 

 

233,666

 

 

 

22,707

 

 

 

929

 

 

     Other infectious disease revenues

 

127

 

 

 

183

 

 

 

(31

)

 

 

 

547

 

 

 

718

 

 

 

(24

)

 

  Total Infectious Disease

 

103,406

 

 

 

29,753

 

 

 

248

 

 

 

 

286,394

 

 

 

77,352

 

 

 

270

 

 

  Risk Assessment

 

2,483

 

 

 

2,406

 

 

 

3

 

 

 

 

10,269

 

 

 

9,678

 

 

 

6

 

 

  Other non-product revenues

 

1,368

 

 

 

509

 

 

 

169

 

 

 

 

7,010

 

 

 

3,010

 

 

 

133

 

 

TOTAL DIAGNOSTIC NET REVENUE

 

107,257

 

 

 

32,668

 

 

 

228

 

 

 

 

303,673

 

 

 

90,040

 

 

 

237

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MOLECULAR SOLUTIONS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Genomics

$

9,777

 

 

$

14,017

 

 

 

(30

)

 

 

$

54,335

 

 

$

63,350

 

 

 

(14

)

 

     Microbiome

 

1,920

 

 

 

2,050

 

 

 

(6

)

 

 

 

7,503

 

 

 

7,944

 

 

 

(6

)

 

     COVID-19

 

137

 

 

 

7,964

 

 

 

(98

)

 

 

 

9,659

 

 

 

54,167

 

 

 

(82

)

 

     Laboratory services

 

2,401

 

 

 

3,824

 

 

 

(37

)

 

 

 

7,296

 

 

 

11,840

 

 

 

(38

)

 

     Other product and services revenues

 

699

 

 

 

1,334

 

 

 

(48

)

 

 

 

2,591

 

 

 

2,566

 

 

 

1

 

 

Net product and service revenues

 

14,934

 

 

 

29,189

 

 

 

(49

)

 

 

 

81,384

 

 

 

139,867

 

 

 

(42

)

 

  Other non-product and service revenues

 

887

 

 

 

1,711

 

 

 

(48

)

 

 

 

2,422

 

 

 

3,767

 

 

 

(36

)

 

TOTAL MOLECULAR SOLUTIONS NET REVENUE

 

15,821

 

 

 

30,900

 

 

 

(49

)

 

 

 

83,806

 

 

 

143,634

 

 

 

(42

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TOTAL NET REVENUES

$

123,078

 

 

$

63,568

 

 

 

94

 

%

 

$

387,479

 

 

$

233,674

 

 

 

66

 

%

 

Condensed Consolidated Balance Sheets (Unaudited)

 

 

 

 

 

 

December 31, 2022

 

 

December 31, 2021

 

Assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

83,980

 

 

$

116,762

 

Short-term investments

 

 

26,867

 

 

 

36,279

 

Accounts receivable, net

 

 

70,797

 

 

 

45,323

 

Inventories

 

 

96,232

 

 

 

53,138

 

Other current assets

 

 

47,842

 

 

 

47,804

 

Property, plant and equipment, net

 

 

59,413

 

 

 

73,435

 

Intangible assets, net

 

 

11,694

 

 

 

14,343

 

Goodwill

 

 

35,104

 

 

 

40,279

 

Long-term investments

 

 

 

 

 

17,009

 

Other noncurrent assets

 

 

12,779

 

 

 

16,618

 

Total assets

 

$

444,708

 

 

$

460,990

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Accounts payable

 

$

39,349

 

 

$

28,024

 

Deferred revenue

 

 

2,273

 

 

 

2,936

 

Other current liabilities

 

 

28,770

 

 

 

37,104

 

Other non-current liabilities

 

 

10,692

 

 

 

12,393

 

Stockholders’ equity

 

 

363,624

 

 

 

380,533

 

Total liabilities and stockholders’ equity

 

$

444,708

 

 

$

460,990

 

 

6

 


 

Additional Financial Data (Unaudited)

 

Year Ended

 

 

 

December 31,

 

 

 

2022

 

 

2021

 

Capital expenditures

 

$

4,545

 

 

$

48,117

 

Depreciation and amortization

 

$

15,308

 

 

$

11,658

 

Stock-based compensation

 

$

11,622

 

 

$

7,807

 

Cash used in operating activities

 

$

(47,202

)

 

$

35,382

 

 

 

Conference Call

 

The Company will host a conference call and audio webcast for analysts and investors to discuss the Company’s fourth quarter 2022 results and certain business developments, beginning today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will be Carrie Eglinton Manner, President and Chief Executive Officer, Ken McGrath, Chief Financial Officer, and Scott Gleason, SVP Investor Relations and Corporate Communications. The call will include prepared remarks by management and a question and answer session.

In order to listen to the conference call, please register to obtain a dial in and pin at the following link:

 

https://register.vevent.com/register/BIf712ba49243f46c7a741f490d1ea19a4

 

To listen to the webcast, 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 14 days. It is recommended to dial-in 15 to 20 minutes prior to the call start to reduce waiting times. If a participant will be listen-only, they are encouraged to listen via the webcast on OraSure’s Investor Relations page.

 

About InteliSwab®

OraSure has received Emergency Use Authorizations (EUA) from the FDA for its InteliSwab® COVID-19 rapid tests. The FDA has authorized the InteliSwab® COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. The FDA has also authorized the InteliSwab® COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and the InteliSwab® COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. The InteliSwab® test’s unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result. With less than one minute of “hands-on time,” it is as simple as “Swab, Swirl, and See.”

This product has not been FDA cleared or approved, but it has been authorized by the FDA under an EUA. The emergency use of this product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

 

Multiple government agencies, including the U.S. Department of Defense (DoD) and Department of Health and Human Services (HHS) are working to address COVID-19 testing needs. Development of the InteliSwab®

7

 


 

COVID-19 Rapid Test has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50120C00061 and 75A50121C00078, utilizing Health Care Enhancement Act (HCEA) funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the manufacturing expansion effort for the InteliSwab® COVID-19 rapid test in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT). The manufacturing effort was funded through the American Rescue Plan Act (ARPA) to enable and support domestic industrial base expansion for critical medical resources.

 

About OraSure Technologies

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, 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 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, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

 

Forward Looking Statements
 

This press release contains certain forward-looking statements, including with respect to products, product development activities, regulatory submissions and authorizations, revenue growth, cost savings, cash flow, increasing margins and other matters. 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: our ability to satisfy customer demand; ability to reduce our spending rate, capitalize on manufacturing efficiencies and drive profitable growth; ability to achieve the anticipated cost savings as a result of our business restructuring; 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 effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration (“FDA”) or other regulators; the impact of the novel coronavirus (“COVID-19”) pandemic on the Company's business, supply chain, labor force, ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing, and demand for our COVID-19 testing products ; 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 and the

8

 


 

ability to continue to reduce costs; 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, civil unrest, hostilities and war ; and general political, business and economic conditions, including inflationary pressures. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2021, 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 OraSure Technologies undertakes no duty to update these statements.

Statement Regarding Use of Non-GAAP Financial Measures

In this press release, the company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures, including non-GAAP gross margin, non-GAAP operating income (loss), and non-GAAP earnings (loss) per share. Management believes that presentation of operating results using these non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the company’s core operating results and comparison of operating results across reporting periods, while excluding certain expenses that may not be indicative of the Company’s recurring core business operating results. In addition, management believes these non-GAAP financial measures are useful to investors both because they (1) allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) are used by OraSure’s institutional investors and the analysis community to help them analyze the health of OraSure’s business. Management also uses non-GAAP financial measures to establish budgets and to manage the company’s business. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the schedules below and a description of the adjustments made to the GAAP financial measures is included at the end of the schedules.

9

 


 

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Non-GAAP financial results are reported in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Further, non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared.

OraSure Technologies GAAP to Non-GAAP Reconciliation ($ in 000's)

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Year Ended

 

 

December 31,

 

 

December 31,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

$

123,078

 

 

$

63,568

 

 

$

387,479

 

 

$

233,674

 

GAAP Cost of Goods Sold

$

73,489

 

 

 

36,435

 

 

 

239,842

 

 

 

116,074

 

GAAP Gross Margin

 

40

%

 

 

43

%

 

 

38

%

 

 

50

%

Stock compensation

 

140

 

 

 

162

 

 

 

331

 

 

 

572

 

Amortization of acquisition-related intangible assets

 

132

 

 

 

132

 

 

 

528

 

 

 

528

 

Transformation related expenses

 

265

 

 

 

-

 

 

 

1,599

 

 

 

-

 

Inventory reserve for excess levels

 

-

 

 

 

1,258

 

 

 

4,369

 

 

 

3,008

 

Non-GAAP Cost of Goods Sold

 

72,952

 

 

 

34,883

 

 

 

233,015

 

 

 

111,966

 

Non-GAAP Gross Margin

 

40.7

%

 

 

45.1

%

 

 

39.9

%

 

 

52.1

%

 

 

 

 

 

 

 

 

 

 

 

 

GAAP Operating Income (Loss)

 

13,435

 

 

 

(9,371

)

 

 

(22,957

)

 

 

(10,164

)

Stock compensation

 

2,349

 

 

 

2,020

 

 

 

9,154

 

 

 

7,177

 

Amortization of acquisition-related intangible assets

 

467

 

 

 

707

 

 

 

1,937

 

 

 

2,843

 

Inventory reserve for excess levels

 

-

 

 

 

1,258

 

 

 

4,369

 

 

 

3,008

 

Loss on impairment

 

-

 

 

 

-

 

 

 

17,101

 

 

 

-

 

Transformation related expenses

 

520

 

 

 

1,200

 

 

 

6,191

 

 

 

1,200

 

Severance expense

 

300

 

 

 

2,683

 

 

 

3,850

 

 

 

2,683

 

Strategic alternative costs

 

-

 

 

 

126

 

 

 

848

 

 

 

126

 

Government grant accounting

 

1,422

 

 

 

-

 

 

 

1,422

 

 

 

-

 

Change in fair value of acquisition-related contingent consideration

 

(152

)

 

 

41

 

 

 

(188

)

 

 

(1,485

)

Non-GAAP Operating Income (Loss)

 

18,340

 

 

 

(1,336

)

 

 

21,726

 

 

 

5,388

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP Net Income (Loss)

 

15,561

 

 

 

(10,393

)

 

 

(17,935

)

 

 

(22,998

)

Stock compensation

 

2,349

 

 

 

2,020

 

 

 

9,154

 

 

 

7,177

 

Amortization of acquisition-related intangible assets

 

467

 

 

 

707

 

 

 

1,937

 

 

 

2,843

 

Inventory reserve for excess levels

 

-

 

 

 

1,258

 

 

 

4,369

 

 

 

3,008

 

Loss on impairment

 

-

 

 

 

-

 

 

 

17,101

 

 

 

-

 

Transformation related expenses

 

520

 

 

 

1,200

 

 

 

6,191

 

 

 

1,200

 

Severance expense

 

300

 

 

 

2,683

 

 

 

3,850

 

 

 

2,683

 

Strategic alternative costs

 

-

 

 

 

126

 

 

 

848

 

 

 

126

 

Change in fair value of acquisition-related contingent consideration

 

(152

)

 

 

41

 

 

 

(188

)

 

 

(1,485

)

Tax effect of Non-GAAP adjustments

 

6,997

 

 

 

(132

)

 

 

(340

)

 

 

(401

)

Non-GAAP Net Income (Loss)

$

26,041

 

 

$

(2,490

)

 

$

24,986

 

 

$

(7,847

)

 

 

 

 

 

 

 

 

 

 

 

 

GAAP Earnings (Loss) Per Share:

$

0.21

 

 

$

(0.14

)

 

$

(0.25

)

 

$

(0.32

)

Non-GAAP Earnings (Loss) Per Share:

$

0.36

 

 

$

(0.03

)

 

$

0.34

 

 

$

(0.11

)

     Diluted Shares Outstanding

 

73,248

 

 

 

72,040

 

 

 

72,505

 

 

 

71,981

 

Following is a description of the adjustments made to GAAP financial measures:

Stock Compensation: non-cash equity-based compensation provided to OraSure employees and directors, excluding accelerated stock compensation as required under former employees’ employment agreements

10

 


 

Amortization of acquisition-related intangible assets: represents recurring amortization charges resulting from the acquisition of intangible assets associated with our business combinations
Inventory reserve for excess levels: reserves recorded for inventory balances that are deemed excess based on current forecasts and expirations dates
Loss on impairment: charges related to the write down of company assets including PP&E and Goodwill
Transformation related expenses: transitory costs such as consulting and professional fees related to transformation initiatives
Strategic alternative costs: one-time expenses such as legal and banking fees tied to the company’s strategic alternative process
Severance expenses: Expenses tied to executive severance agreements including accelerated stock compensation
Government contract accounting: As required under International Accounting Standard Board IAS 20, Accounting for Government Contracts and Disclosure of Government Assistance, our operating expenses associated with the Department of Defense expansion contract are reflected in operating expenses with offsetting reimbursement reflected in other income
Change in fair value of acquisition-related contingent consideration: changes in the fair value of contingent consideration liability associated with estimate changes in reaching contingent consideration metrics
Tax impact associated with non-GAAP adjustments – tax expense/(benefit) due to non-GAAP adjustments

###

11