false 2020 Q1 0001116463 --12-31 Large Accelerated Filer P2Y P2Y P2Y P1Y6M true true 2020 P1Y P3Y P10Y P10Y P8Y4M2D P10Y P9Y P5Y18D P3Y3M7D 0001116463 2020-01-01 2020-03-31 xbrli:shares 0001116463 2020-05-01 iso4217:USD 0001116463 2020-03-31 0001116463 2019-12-31 iso4217:USD xbrli:shares 0001116463 osur:ProductAndServicesMember 2020-01-01 2020-03-31 0001116463 osur:ProductAndServicesMember 2019-01-01 2019-03-31 0001116463 osur:OtherRevenuesMember 2020-01-01 2020-03-31 0001116463 osur:OtherRevenuesMember 2019-01-01 2019-03-31 0001116463 2019-01-01 2019-03-31 0001116463 2018-12-31 0001116463 2019-03-31 0001116463 osur:CorebiomeIncAndNovosanisNVMember 2020-01-01 2020-03-31 0001116463 osur:DiversigenIncMember 2020-01-01 2020-03-31 0001116463 osur:PerformanceBasedRestrictedStockUnitMember 2020-01-01 2020-03-31 osur:Segment 0001116463 osur:GuaranteedInvestmentCertificatesMember 2020-03-31 0001116463 osur:CorporateBondsMember 2020-03-31 0001116463 osur:GuaranteedInvestmentCertificatesMember 2019-12-31 0001116463 osur:CorporateBondsMember 2019-12-31 0001116463 osur:MaturityOfAvailableForSaleSecurityLessThanOneYearMember 2020-03-31 0001116463 osur:MaturityOfAvailableForSaleSecurityGreaterThanOneYearMember 2020-03-31 0001116463 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member 2020-03-31 0001116463 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member 2019-12-31 0001116463 srt:MinimumMember us-gaap:BuildingMember 2020-01-01 2020-03-31 0001116463 us-gaap:BuildingMember srt:MaximumMember 2020-01-01 2020-03-31 0001116463 srt:MinimumMember us-gaap:ComputerEquipmentMember 2020-01-01 2020-03-31 0001116463 srt:MaximumMember us-gaap:ComputerEquipmentMember 2020-01-01 2020-03-31 0001116463 srt:MinimumMember us-gaap:MachineryAndEquipmentMember 2020-01-01 2020-03-31 0001116463 srt:MaximumMember us-gaap:MachineryAndEquipmentMember 2020-01-01 2020-03-31 0001116463 srt:MinimumMember us-gaap:FurnitureAndFixturesMember 2020-01-01 2020-03-31 0001116463 srt:MaximumMember us-gaap:FurnitureAndFixturesMember 2020-01-01 2020-03-31 0001116463 srt:MinimumMember 2020-01-01 2020-03-31 0001116463 srt:MaximumMember 2020-01-01 2020-03-31 0001116463 us-gaap:IntellectualPropertyMember 2020-01-01 2020-03-31 0001116463 2019-01-01 0001116463 osur:CommonStockOptionsUnvestedRestrictedStockAndUnvestedPerformanceUnitsMember 2020-01-01 2020-03-31 0001116463 osur:CommonStockOptionsUnvestedRestrictedStockAndUnvestedPerformanceUnitsMember 2019-01-01 2019-03-31 0001116463 osur:CorebiomeIncAndNovosanisNVMember 2019-01-04 2019-01-04 0001116463 osur:CorebiomeIncAndNovosanisNVMember 2019-01-01 2019-03-31 0001116463 osur:CorebiomeIncAndNovosanisNVMember 2019-01-04 0001116463 osur:CorebiomeIncAndNovosanisNVMember 2019-12-31 0001116463 osur:CorebiomeIncAndNovosanisNVMember 2019-03-31 0001116463 osur:CorebiomeIncAndNovosanisNVMember 2020-03-31 0001116463 osur:CorebiomeIncAndNovosanisNVMember srt:MaximumMember 2020-03-31 0001116463 osur:CorebiomeIncAndNovosanisNVMember us-gaap:DevelopedTechnologyRightsMember 2019-01-04 0001116463 osur:CorebiomeIncAndNovosanisNVMember us-gaap:CustomerRelationshipsMember 2019-01-04 0001116463 osur:CorebiomeIncAndNovosanisNVMember us-gaap:TradeNamesMember 2019-01-04 0001116463 osur:CorebiomeIncAndNovosanisNVMember us-gaap:DevelopedTechnologyRightsMember 2019-01-04 2019-01-04 0001116463 osur:CorebiomeIncAndNovosanisNVMember us-gaap:CustomerRelationshipsMember 2019-01-04 2019-01-04 0001116463 osur:CorebiomeIncAndNovosanisNVMember us-gaap:TradeNamesMember 2019-01-04 2019-01-04 0001116463 osur:DiversigenIncMember 2019-11-08 2019-11-08 0001116463 osur:DiversigenIncMember 2019-01-01 2019-03-31 0001116463 osur:DiversigenIncMember 2020-03-31 0001116463 osur:DiversigenIncMember 2019-11-08 0001116463 osur:DiversigenIncMember us-gaap:CustomerRelationshipsMember 2019-11-08 0001116463 osur:DiversigenIncMember us-gaap:TradeNamesMember 2019-11-08 0001116463 osur:DiversigenIncMember us-gaap:CustomerRelationshipsMember 2019-11-08 2019-11-08 0001116463 osur:DiversigenIncMember us-gaap:TradeNamesMember 2019-11-08 2019-11-08 0001116463 osur:CorebiomeIncDiversigenAndNovosanisNVMember 2019-01-01 2019-03-31 0001116463 osur:OraquickMember us-gaap:SalesMember 2020-01-01 2020-03-31 0001116463 osur:OraquickMember us-gaap:SalesMember 2019-01-01 2019-03-31 0001116463 osur:OrageneMember us-gaap:SalesMember 2020-01-01 2020-03-31 0001116463 osur:OrageneMember us-gaap:SalesMember 2019-01-01 2019-03-31 0001116463 osur:ORAcollectMember us-gaap:SalesMember 2020-01-01 2020-03-31 0001116463 osur:ORAcollectMember us-gaap:SalesMember 2019-01-01 2019-03-31 0001116463 osur:InterceptMember us-gaap:SalesMember 2020-01-01 2020-03-31 0001116463 osur:InterceptMember us-gaap:SalesMember 2019-01-01 2019-03-31 0001116463 osur:MicrobiomeLaboratoryServicesMember us-gaap:SalesMember 2020-01-01 2020-03-31 0001116463 osur:MicrobiomeLaboratoryServicesMember us-gaap:SalesMember 2019-01-01 2019-03-31 0001116463 osur:OMNIGeneGUTMember us-gaap:SalesMember 2020-01-01 2020-03-31 0001116463 osur:OMNIGeneGUTMember us-gaap:SalesMember 2019-01-01 2019-03-31 0001116463 osur:HistofreezerMember us-gaap:SalesMember 2019-01-01 2019-03-31 0001116463 osur:OtherProductsMember us-gaap:SalesMember 2020-01-01 2020-03-31 0001116463 osur:OtherProductsMember us-gaap:SalesMember 2019-01-01 2019-03-31 0001116463 us-gaap:SalesMember 2020-01-01 2020-03-31 0001116463 us-gaap:SalesMember 2019-01-01 2019-03-31 0001116463 osur:RoyaltyIncomeMember us-gaap:OtherIncomeMember 2020-01-01 2020-03-31 0001116463 osur:RoyaltyIncomeMember us-gaap:OtherIncomeMember 2019-01-01 2019-03-31 0001116463 osur:OtherNonProductRevenuesMember us-gaap:OtherIncomeMember 2020-01-01 2020-03-31 0001116463 osur:OtherNonProductRevenuesMember us-gaap:OtherIncomeMember 2019-01-01 2019-03-31 0001116463 us-gaap:OtherIncomeMember 2020-01-01 2020-03-31 0001116463 us-gaap:OtherIncomeMember 2019-01-01 2019-03-31 0001116463 country:US 2020-01-01 2020-03-31 0001116463 country:US 2019-01-01 2019-03-31 0001116463 srt:EuropeMember 2020-01-01 2020-03-31 0001116463 srt:EuropeMember 2019-01-01 2019-03-31 0001116463 osur:OtherForeignCountriesMember 2020-01-01 2020-03-31 0001116463 osur:OtherForeignCountriesMember 2019-01-01 2019-03-31 xbrli:pure 0001116463 us-gaap:CustomerConcentrationRiskMember us-gaap:AccountsReceivableMember osur:CustomerMember 2020-01-01 2020-03-31 0001116463 us-gaap:CustomerConcentrationRiskMember us-gaap:AccountsReceivableMember osur:CustomerMember 2019-01-01 2019-12-31 0001116463 us-gaap:CustomerConcentrationRiskMember us-gaap:SalesRevenueNetMember osur:CustomerMember srt:MaximumMember 2020-01-01 2020-03-31 0001116463 us-gaap:CustomerConcentrationRiskMember us-gaap:SalesRevenueNetMember osur:CustomerMember srt:MaximumMember 2019-01-01 2019-03-31 osur:Supplier 0001116463 osur:DNAGenotekMember 2020-03-31 0001116463 us-gaap:UpFrontPaymentArrangementMember 2020-03-31 0001116463 us-gaap:UpFrontPaymentArrangementMember 2019-12-31 0001116463 us-gaap:LongTermContractWithCustomerMember 2020-03-31 0001116463 us-gaap:LongTermContractWithCustomerMember 2019-12-31 0001116463 us-gaap:CommonStockMember 2019-12-31 0001116463 us-gaap:AdditionalPaidInCapitalMember 2019-12-31 0001116463 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-12-31 0001116463 us-gaap:RetainedEarningsMember 2019-12-31 0001116463 us-gaap:CommonStockMember 2020-01-01 2020-03-31 0001116463 us-gaap:AdditionalPaidInCapitalMember 2020-01-01 2020-03-31 0001116463 us-gaap:RetainedEarningsMember 2020-01-01 2020-03-31 0001116463 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-01-01 2020-03-31 0001116463 us-gaap:CommonStockMember 2020-03-31 0001116463 us-gaap:AdditionalPaidInCapitalMember 2020-03-31 0001116463 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-03-31 0001116463 us-gaap:RetainedEarningsMember 2020-03-31 0001116463 us-gaap:CommonStockMember 2018-12-31 0001116463 us-gaap:AdditionalPaidInCapitalMember 2018-12-31 0001116463 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-12-31 0001116463 us-gaap:RetainedEarningsMember 2018-12-31 0001116463 us-gaap:CommonStockMember 2019-01-01 2019-03-31 0001116463 us-gaap:AdditionalPaidInCapitalMember 2019-01-01 2019-03-31 0001116463 us-gaap:RetainedEarningsMember 2019-01-01 2019-03-31 0001116463 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-01-01 2019-03-31 0001116463 us-gaap:CommonStockMember 2019-03-31 0001116463 us-gaap:AdditionalPaidInCapitalMember 2019-03-31 0001116463 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-03-31 0001116463 us-gaap:RetainedEarningsMember 2019-03-31 0001116463 us-gaap:EmployeeStockOptionMember 2020-01-01 2020-03-31 0001116463 us-gaap:EmployeeStockOptionMember 2019-01-01 2019-03-31 0001116463 us-gaap:RestrictedStockMember 2020-01-01 2020-03-31 0001116463 us-gaap:RestrictedStockMember 2019-01-01 2019-03-31 0001116463 osur:RestrictedStockAwardAndRestrictedStockUnitsMember 2019-12-31 0001116463 osur:RestrictedStockAwardAndRestrictedStockUnitsMember 2020-01-01 2020-03-31 0001116463 osur:RestrictedStockAwardAndRestrictedStockUnitsMember 2020-03-31 0001116463 us-gaap:ShareBasedCompensationAwardTrancheOneMember osur:PerformanceBasedRestrictedStockMember 2020-01-01 2020-03-31 0001116463 us-gaap:ShareBasedCompensationAwardTrancheTwoMember osur:PerformanceBasedRestrictedStockMember 2020-01-01 2020-03-31 0001116463 osur:PerformanceBasedRestrictedStockUnitMember 2019-01-01 2019-03-31 0001116463 osur:PerformanceBasedRestrictedStockUnitMember 2019-12-31 0001116463 osur:PerformanceBasedRestrictedStockUnitMember 2020-03-31 0001116463 osur:StockRepurchaseProgramMember 2020-01-01 2020-03-31 0001116463 osur:StockRepurchaseProgramMember 2019-01-01 2019-03-31 0001116463 2008-08-05 0001116463 osur:OSURMember 2020-01-01 2020-03-31 0001116463 osur:OSURMember 2019-01-01 2019-03-31 0001116463 osur:DNAGMember 2020-01-01 2020-03-31 0001116463 osur:DNAGMember 2019-01-01 2019-03-31 0001116463 osur:OSURMember 2020-03-31 0001116463 osur:OSURMember 2019-12-31 0001116463 osur:DNAGMember 2020-03-31 0001116463 osur:DNAGMember 2019-12-31

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2020.

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                      .

Commission File Number 001-16537

 

ORASURE TECHNOLOGIES, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

 

 

Delaware

 

36-4370966

(State or Other Jurisdiction of

Incorporation or Organization)

 

(IRS Employer Identification No.)

 

 

 

 

220 East First Street, Bethlehem, Pennsylvania

 

18015

(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

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes      No  

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).    Yes      No  

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

 

 

 

 

 

 

 

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

 

 

 

Non-accelerated filer

 

☐  

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

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.    

Indicate by checkmark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  

As of May 1, 2020, the registrant had 62,066,000 shares of common stock, $.000001 par value per share, outstanding.

 


 

PART I. FINANCIAL INFORMATION

 

 

 

 

Page
No.

 

 

Item 1. Financial Statements (Unaudited)

 

 

 

Consolidated Balance Sheets at March 31, 2020 and December 31, 2019

3

 

 

Consolidated Statements of Operations for the three months ended March 31, 2020 and 2019

4

 

 

Consolidated Statements of Comprehensive Income (Loss) for the three months ended March 31, 2020 and 2019

5

 

 

Consolidated Statements of Cash Flows for the three months ended March 31, 2020 and 2019

6

 

 

Notes to the Consolidated Financial Statements

7

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

20

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

26

 

 

Item 4. Controls and Procedures

27

 

 

PART II. OTHER INFORMATION

 

 

 

Item 1. Legal Proceedings

28

 

 

Item 1A. Risk Factors

28

 

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

30

 

 

Item 3. Defaults Upon Senior Securities

30

 

 

Item 4. Mine Safety Disclosures

30

 

 

Item 5. Other Information

30

 

 

Item 6. Exhibits

31

 

 

Signatures

32

 

 

 

-2-


 

Item 1.

FINANCIAL STATEMENTS

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

(in thousands, except per share amounts)

 

 

March 31, 2020

 

 

December 31, 2019

 

ASSETS

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

83,365

 

 

$

75,715

 

Short-term investments

 

82,735

 

 

 

80,623

 

Accounts receivable, net of allowance for doubtful accounts of $2,511 and $2,666

 

27,861

 

 

 

36,948

 

Inventories

 

22,694

 

 

 

23,155

 

Prepaid expenses

 

2,912

 

 

 

2,433

 

Other current assets

 

3,878

 

 

 

5,676

 

Total current assets

 

223,445

 

 

 

224,550

 

Noncurrent Assets:

 

 

 

 

 

 

 

Property, plant and equipment, net

 

31,829

 

 

 

30,339

 

Operating right-of-use assets, net

 

4,665

 

 

 

4,996

 

Finance right-of-use assets, net

 

1,818

 

 

 

1,951

 

Intangible assets, net

 

15,746

 

 

 

14,674

 

Goodwill

 

34,544

 

 

 

36,201

 

Long-term investments

 

10,070

 

 

 

33,420

 

Other noncurrent assets

 

2,955

 

 

 

3,164

 

Total noncurrent assets

 

101,627

 

 

 

124,745

 

TOTAL ASSETS

$

325,072

 

 

$

349,295

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

Accounts payable

$

6,881

 

 

$

9,567

 

Deferred revenue

 

4,312

 

 

 

3,713

 

Accrued expenses and other current liabilities

 

12,339

 

 

 

14,288

 

Finance lease liability

 

588

 

 

 

613

 

Operating lease liability

 

999

 

 

 

1,032

 

Acquisition-related contingent consideration obligation

 

1,220

 

 

 

3,500

 

Total current liabilities

 

26,339

 

 

 

32,713

 

Noncurrent Liabilities:

 

 

 

 

 

 

 

Finance lease liability

 

1,281

 

 

 

1,372

 

Operating lease liability

 

3,899

 

 

 

4,206

 

Other noncurrent liabilities

 

2,641

 

 

 

2,960

 

Deferred income taxes

 

760

 

 

 

899

 

Total noncurrent liabilities

 

8,581

 

 

 

9,437

 

TOTAL LIABILITIES

 

34,920

 

 

 

42,150

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

Preferred stock, par value $.000001, 25,000 shares authorized, none issued

 

 

 

 

 

Common stock, par value $.000001, 120,000 shares authorized, 62,026 and 61,731 shares

  issued and outstanding

 

 

 

 

 

Additional paid-in capital

 

401,812

 

 

 

401,814

 

Accumulated other comprehensive loss

 

(21,799

)

 

 

(12,136

)

Accumulated deficit

 

(89,861

)

 

 

(82,533

)

Total stockholders' equity

 

290,152

 

 

 

307,145

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

$

325,072

 

 

$

349,295

 

 

See accompanying notes to the consolidated financial statements.

 

-3-


ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(in thousands, except per share amounts)

 

 

 

Three Months Ended March 31,

 

 

 

2020

 

 

2019

 

NET REVENUES:

 

 

 

 

 

 

 

 

Products and services

 

$

30,886

 

 

$

28,332

 

Other

 

 

710

 

 

 

1,790

 

 

 

 

31,596

 

 

 

30,122

 

COST OF PRODUCTS AND SERVICES SOLD

 

 

15,465

 

 

 

12,042

 

Gross profit

 

 

16,131

 

 

 

18,080

 

OPERATING EXPENSES:

 

 

 

 

 

 

 

 

Research and development

 

 

5,644

 

 

 

4,371

 

Sales and marketing

 

 

7,369

 

 

 

7,295

 

General and administrative

 

 

10,054

 

 

 

8,930

 

Change in the estimated fair value of acquisition-related contingent consideration

 

 

1,110

 

 

 

1,295

 

 

 

 

24,177

 

 

 

21,891

 

Operating loss

 

 

(8,046

)

 

 

(3,811

)

OTHER INCOME

 

 

1,430

 

 

 

524

 

Loss before income taxes

 

 

(6,616

)

 

 

(3,287

)

INCOME TAX (BENEFIT) EXPENSE

 

 

712

 

 

 

(29

)

NET LOSS

 

$

(7,328

)

 

$

(3,258

)

LOSS PER SHARE:

 

 

 

 

 

 

 

 

BASIC

 

$

(0.12

)

 

$

(0.05

)

DILUTED

 

$

(0.12

)

 

$

(0.05

)

SHARES USED IN COMPUTING LOSS PER SHARE:

 

 

 

 

 

 

 

 

BASIC

 

 

61,927

 

 

 

61,531

 

DILUTED

 

 

61,927

 

 

 

61,531

 

 

See accompanying notes to the consolidated financial statements.

-4-


 

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(Unaudited)

(in thousands)

 

 

 

Three Months Ended March 31,

 

 

 

2020

 

 

2019

 

NET LOSS

 

$

(7,328

)

 

$

(3,258

)

OTHER COMPREHENSIVE INCOME (LOSS)

 

 

 

 

 

 

 

 

Currency translation adjustments

 

 

(9,221

)

 

 

2,232

 

Unrealized gain (loss) on marketable securities

 

 

(442

)

 

 

497

 

COMPREHENSIVE LOSS

 

$

(16,991

)

 

$

(529

)

 

See accompanying notes to the consolidated financial statements.

-5-


ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)

 

 

 

Three Months Ended March 31,

 

 

 

2020

 

 

2019

 

OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss

 

$

(7,328

)

 

$

(3,258

)

Adjustments to reconcile net loss to net cash provided by operating activities:

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

1,376

 

 

 

1,231

 

Depreciation and amortization

 

 

2,197

 

 

 

1,726

 

Provision for doubtful accounts

 

 

26

 

 

 

47

 

Unrealized foreign currency (gain) loss

 

 

(224

)

 

 

231

 

Interest expense on finance leases

 

 

20

 

 

 

4

 

Deferred income taxes

 

 

(71

)

 

 

(85

)

Change in the estimated fair value of acquisition-related contingent consideration

 

 

1,110

 

 

 

1,295

 

Payment of acquisition-related contingent consideration

 

 

(496

)

 

 

 

Changes in assets and liabilities

 

 

 

 

 

 

 

 

Accounts receivable

 

 

8,623

 

 

 

10,494

 

Inventories

 

 

248

 

 

 

(2,917

)

Prepaid expenses and other assets

 

 

1,035

 

 

 

416

 

Accounts payable

 

 

(3,094

)

 

 

(253

)

Deferred revenue

 

 

780

 

 

 

661

 

Accrued expenses and other liabilities

 

 

(1,703

)

 

 

(9,064

)

Net cash provided by operating activities

 

 

2,499

 

 

 

528

 

INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Purchases of investments

 

 

(36,945

)

 

 

(44,954

)

Proceeds from maturities and redemptions of investments

 

 

55,811

 

 

 

44,624

 

Purchases of property and equipment

 

 

(2,595

)

 

 

(2,628

)

Proceeds from escrow associated with business acquisitions

 

 

126

 

 

 

 

Acquisition of businesses, net of cash acquired

 

 

 

 

 

(13,256

)

Purchase of patent and product rights

 

 

(2,250

)

 

 

 

Net cash provided by (used in) investing activities

 

 

14,147

 

 

 

(16,214

)

FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Repayments of loans

 

 

 

 

 

(724

)

Cash payments for lease liabilities

 

 

(175

)

 

 

(35

)

Payment of acquisition-related contingent consideration

 

 

(3,004

)

 

 

 

Proceeds from exercise of stock options

 

 

30

 

 

 

22

 

Repurchase of common stock

 

 

(1,408

)

 

 

(3,595

)

Net cash used in financing activities

 

 

(4,557

)

 

 

(4,332

)

EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH

 

 

(4,439

)

 

 

1,096

 

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 

 

7,650

 

 

 

(18,922

)

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

 

75,715

 

 

 

88,438

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

83,365

 

 

$

69,516

 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:

 

 

 

 

 

 

 

 

Cash paid (received) for income taxes

 

$

(85

)

 

$

4,397

 

Non-cash investing and financing activities

 

 

 

 

 

 

 

 

Accrued property and equipment purchases

 

$

1,129

 

 

$

563

 

Unrealized gain (loss) on marketable securities

 

$

(442

)

 

$

497

 

 

See accompanying notes to the consolidated financial statements.

-6-


 

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

Notes to the Consolidated Financial Statements

(Unaudited)

(in thousands, except per share amounts, unless otherwise indicated)

 

1.

The Company

Our business consists of two segments: our “OSUR” business consists of the development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices using our proprietary technologies, other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. Our molecular products and services business, or DNAG business consists of the manufacture and sale of kits that are used to collect, stabilize, transport and store samples of genetic material for molecular testing in the consumer genetic, clinical genetic, academic research, pharmacogenomics, personalized medicine, microbiome and animal genetics markets. Our collection kits are also used for the collection of first-void urine for liquid biopsy in the prostate and bladder cancer markets; and in the sexually transmitted infection screening market. In addition, our DNAG business provides microbiome laboratory and bioinformatics services.

Our OSUR diagnostic products include tests for diseases including HIV and Hepatitis C that are performed on a rapid basis at the point of care and tests that are processed in a laboratory. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. Our HIV product is also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S. and as a self-test to individuals in a number of other countries. We also previously manufactured and sold medical devices used for the removal of benign skin lesions by cryosurgery or freezing. We sold the assets associated with our cryosurgical systems business to a third party in August 2019. See further discussion at Note 4.

Our DNAG business is operated by our subsidiaries, DNA Genotek Inc. (“DNAG”), CoreBiome Inc. (“CoreBiome”), Novosanis NV (“Novosanis”), and Diversigen, Inc. (“Diversigen”).   DNAG’s specimen collection devices provide all-in-one systems for the collection, stabilization, transportation and storage of nucleic acids from human saliva and other sample types for genetic and microbiome applications. CoreBiome and Diversigen provide laboratory and bioinformatics services. Novosanis’ Colli-Pee collection device is designed for the volumetric collection of first-void urine for use in research, screening and diagnostics for the liquid biopsy and sexually transmitted infection markets. We also sell research use only sample collection products into the microbiome market and we offer our customers a suite of genomics and microbiome services, which range from package customization and study design optimization to extraction, analysis and reporting services. We serve customers worldwide in the research, healthcare, pharmaceutical and agricultural communities 

2.

Summary of Significant Accounting Policies

 

Principles of Consolidation and Basis of Presentation. The consolidated financial statements include the accounts of OraSure Technologies, Inc. (“OraSure”) and its wholly-owned subsidiaries, DNAG, CoreBiome, Novosanis and Diversigen. All intercompany transactions and balances have been eliminated. References herein to “we,” “us,” “our,” or the “Company” mean OraSure and its consolidated subsidiaries, unless otherwise indicated.

 

The accompanying consolidated financial statements are unaudited and, in the opinion of management, include all adjustments (consisting only of normal and recurring adjustments) necessary for a fair presentation of our financial position and results of operations for these interim periods. These financial statements should be read in conjunction with the financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019. Results of operations for the three months ended March 31, 2020 are not necessarily indicative of the results of operations expected for the full year.

 

Use of Estimates. The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions about future events. These estimates and underlying assumptions affect the amounts of assets and liabilities reported, disclosures about contingent assets and liabilities, and reported amounts of revenues and expenses. Such estimates include the fair value of assets acquired and liabilities assumed for business combinations, the valuation of accounts receivable and inventories and assumptions utilized in impairment testing for intangible assets and goodwill, as well as calculations related to accruals, taxes, contingent consideration, and performance-based compensation expense, among others. These estimates and assumptions are based on management’s best estimates and judgment. Management evaluates its estimates and assumptions on an ongoing basis, using historical experience and other factors, which management believes to be reasonable under the circumstances, including the current economic environment. As future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Changes in those estimates resulting from continuing changes in the economic environment and other factors will be reflected in the financial statements in those future periods.

 

Investments. We consider all investments in debt securities to be available-for-sale securities. These securities consist of guaranteed investment certificates and corporate bonds with purchased maturities greater than ninety days. Available-for-sale securities are carried at fair value, based upon quoted market prices, with unrealized gains and losses, if any, reported in stockholders’ equity as a component of accumulated other comprehensive loss.

-7-


 

We record an allowance for credit loss for our available-for-sale securities when a decline in investment market value is due to credit-related factors. When evaluating an investment for impairment, we review factors such as the severity of the impairment, changes in underlying credit ratings, forecasted recovery, the Company’s intent to sell or the likelihood that it would be required to sell the investment before its anticipated recovery in market value and the probability that the scheduled cash payments will continue to be made. As of March 31, 2020, we determined that the decline in the market value of our available-for-sale investment was not due to credit-related factors and as such no allowance for credit-loss was necessary.

The following is a summary of our available-for-sale securities as of March 31, 2020 and December 31, 2019:

 

 

 

Amortized

Cost

 

 

Gross

Unrealized

Gains

 

 

Gross

Unrealized

Losses

 

 

Fair Value

 

March 31, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Guaranteed investment certificates

 

$

22,757

 

 

$

 

 

$

 

 

$

22,757

 

Corporate bonds

 

 

70,604

 

 

 

94

 

 

 

(650

)

 

 

70,048

 

Total available-for-sale securities

 

$

93,361

 

 

$

94

 

 

$

(650

)

 

$

92,805

 

December 31, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Guaranteed investment certificates

 

$

24,632

 

 

$

 

 

$

 

 

$

24,632

 

Corporate bonds

 

 

89,525

 

 

 

271

 

 

 

(385

)

 

 

89,411

 

Total available-for-sale securities

 

$

114,157

 

 

$

271

 

 

$

(385

)

 

$

114,043

 

At March 31, 2020, maturities of our available-for-sale

   securities were as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Less than one year

 

$

83,274

 

 

$

94

 

 

$

(633

)

 

$

82,735

 

Greater than one year

 

$

10,087

 

 

$

 

 

$

(17

)

 

$

10,070

 

 

Fair Value of Financial Instruments. As of March 31, 2020 and December 31, 2019, the carrying values of cash and cash equivalents, accounts receivable, and accounts payable approximate their respective fair values based on their short-term nature.

Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified and disclosed in one of the following three categories:

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and

Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

All of our available-for-sale securities are measured as Level 2 instruments as of March 31, 2020 and December 31, 2019.

Included in cash and cash equivalents at March 31, 2020 and December 31, 2019, was $21,660 and $1,624 invested in government money market funds. These funds have investments in government securities and are measured as Level 1 instruments.

We offer a nonqualified deferred compensation plan for certain eligible employees and members of our Board of Directors. The assets of the plan are held in the name of the Company at a third-party financial institution. Separate accounts are maintained for each participant to reflect the amounts deferred by the participant and all earnings and losses on those deferred amounts. The assets of the plan are held in mutual funds. The fair value of the plan assets as of March 31, 2020 and December 31, 2019 was $3,444 and $3,519, respectively, and was calculated using the quoted market prices of the assets as of those dates. All investments in the plan are classified as trading securities and measured as Level 1 instruments. The fair value of plan assets is included in both current assets and noncurrent assets with the same amount included in accrued expenses and other noncurrent liabilities in the accompanying consolidated balance sheets.

-8-


Accounts Receivable. Accounts receivable have been reduced by an estimated allowance for amounts that may become uncollectible in the future. This estimated allowance is based primarily on management’s evaluation of specific balances as they become past due, the financial condition of our customers and our historical experience related to write-offs.

Inventories. Inventories are stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis, and consist of the following:

 

 

 

March 31,

2020

 

 

December 31,

2019

 

Raw materials

 

$

13,927

 

 

$

14,168

 

Work in process

 

 

865

 

 

 

643

 

Finished goods

 

 

7,902

 

 

 

8,344

 

 

 

$

22,694

 

 

$

23,155

 

 

Property, Plant and Equipment. Property, plant and equipment are stated at cost. Additions or improvements are capitalized, while repairs and maintenance are charged to expense. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the related assets. Buildings are depreciated over twenty to forty years, while computer equipment, machinery and equipment, and furniture and fixtures are depreciated over two to ten years. Building improvements are amortized over their estimated useful lives. When assets are sold, retired, or discarded, the related property amounts are relieved from the accounts, and any gain or loss is recorded in the consolidated statements of operations. Accumulated depreciation of property, plant and equipment as of March 31, 2020 and December 31, 2019 was $49,417 and $46,882, respectively.

Intangible Assets. Intangible assets consist of customer relationships, patents and product rights, acquired technology and tradenames. Patents and product rights consist of costs associated with the acquisition of patents, licenses, and product distribution rights. Intangible assets are amortized using the straight-line method over their estimated useful lives of five to fifteen years. Accumulated amortization of intangible assets as of March 31, 2020 and December 31, 2019 was $22,812 and $23,420, respectively. The change in intangibles from $14,674 as of December 31, 2019 to $15,746 as of March 31, 2020 is a result of the acquisition of patent and product rights of $2,250 offset by foreign currency translation losses of $446 and $732 in amortization expense.  

Goodwill. Goodwill represents the excess of the purchase price we paid over the fair value of the net tangible and identifiable intangible assets acquired and liabilities assumed in our acquisitions of DNAG, CoreBiome, Novosanis and Diversigen. All acquired goodwill has been allocated to our DNAG segment. Goodwill is not amortized but rather is tested annually for impairment or more frequently if we believe that indicators of impairment exist. Current U.S. generally accepted accounting principles permit us to make a qualitative evaluation about the likelihood of goodwill impairment. If we conclude that it is more likely than not that the carrying value of a reporting unit is greater than its fair value, then we would be required to recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated to the reporting unit.

The decrease in goodwill from $36,201 as of December 31, 2019 to $34,544 as of March 31, 2020 is a result of a purchase price adjustment related to one of our acquisitions of $126 and a decrease of $1,531 associated with foreign currency translation.

Leases. In February 2019, the FASB issued ASU No. 2016-02, Leases. The standard requires lessees to recognize lease assets and lease liabilities on the balance sheet and requires expanded disclosures about leasing arrangements. We adopted this standard on January 1, 2019 on a modified retrospective basis and did not restate comparative amounts. Also, we elected the practical expedients permitted under the transition guidance, which allows us to carryforward our historical lease classification, our assessment on whether a contract is or contains a lease, and our initial direct costs for any leases that exist prior to adoption of the new standard. Leases with an initial term of 12 months or less are not recognized on the balance sheet and the associated lease payments are included in the consolidated statements of operations on a straight-line basis over the lease term. As a result, on January 1, 2019, we recorded right-of-use assets of $4,027 and lease liabilities of $4,263 on our consolidated balance sheet.

Business Combinations and Contingent Consideration. Acquired businesses are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. Amounts allocated to contingent consideration are recorded to the balance sheet at the date of acquisition based on their relative fair values. The purchase price allocation requires us to make significant estimates and assumptions, especially at the acquisition date, with respect to intangible assets. Although we believe the assumptions and estimates we have made are reasonable, they are based in part on historical experience and information obtained from the management of the acquired companies and are inherently uncertain.

We account for contingent consideration in accordance with applicable guidance provided within the business combination accounting standard. As part of our consideration for the CoreBiome and Novosanis acquisitions, we are contractually obligated to pay certain consideration resulting from the outcome of future events. Therefore, we are required to update our underlying assumptions each reporting period, based on new developments, and record such contingent consideration liabilities at fair value until the contingency is resolved. Changes in the fair value of the contingent consideration liabilities are recognized each reporting period and included in our consolidated statements of operations.  Our estimates

-9-


of fair value are based on assumptions we believe to be reasonable, but the assumptions are uncertain and involve significant judgment by management.  Updates to these assumptions could have a significant impact on our results of operations in any given period and any updates to the fair value of the contingent consideration could differ materially from the previous estimates.

Examples of critical estimates used in valuing certain intangible assets and contingent consideration include:

 

 

 

 

 

 

• 

 

future expected cash flows from sales and acquired developed technologies;

 

 

 

 

 

 

• 

 

the acquired company's trade name and customer relationships as well as assumptions about the period of time the acquired trade name and customer relationships will continue to be used in the combined company's portfolio;

 

 

 

 

 

 

• 

 

the probability of meeting the future events; and

 

 

 

 

 

 

• 

 

discount rates used to determine the present value of estimated future cash flows.

 

Loss Per Share. Basic and diluted loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted loss per share is generally computed assuming the exercise or vesting of all dilutive securities such as common stock options, unvested performance stock units, and unvested restricted stock. Basic and dilutive computations of net loss per share are the same in periods in which a net loss exists as the dilutive effects of excluded items would be anti-dilutive.

 

For the three months ended March 31, 2020 and 2019, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 312 and 779 shares, respectively, were excluded from the computation of diluted earnings per share as their inclusion would have been anti-dilutive.       

Foreign Currency Translation. The assets and liabilities of our foreign operations are translated into U.S. dollars at current exchange rates as of the balance sheet date, and revenues and expenses are translated at average exchange rates for the period. Resulting translation adjustments are reflected in accumulated other comprehensive loss, which is a separate component of stockholders’ equity.

Transaction gains and losses resulting from exchange rate changes on transactions denominated in currencies other than a functional currency are included in our consolidated statements of operations in the period in which the change occurs. Net foreign exchange gains (losses) resulting from foreign currency transactions that are included in other income in our consolidated statements of income were $693 and $(609) for the three months ended March 31, 2020 and 2019, respectively.     

Accumulated Other Comprehensive Income (Loss). We classify items of other comprehensive income (loss) by their nature and disclose the accumulated balance of other comprehensive loss separately from accumulated deficit and additional paid-in capital in the stockholders’ equity section of our consolidated balance sheets.

We have defined the Canadian dollar as the functional currency of our Canadian subsidiary, DNAG, and we have defined the Euro as the functional currency of our Belgian subsidiary, Novosanis. The results of operations for those subsidiaries are translated into U.S. dollars, which is the reporting currency of the Company. Accumulated other comprehensive loss at March 31, 2020 consists of $21,243 of currency translation adjustments and $556 of net unrealized losses on marketable securities, which represents the fair market value adjustment for our investment portfolio. Accumulated other comprehensive loss at December 31, 2019 consists of $12,022 of currency translation adjustments and $114 of net unrealized losses on marketable securities.

Recent Accounting Pronouncements.  In June 2016, the FASB issued guidance on the measurement of credit losses, which requires measurement and recognition of expected credit losses for financial assets, including trade receivables and capital lease receivables, held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. The method to determine a loss is different from the existing guidance, which requires a credit loss to be recognized when it is probable. We adopted this guidance in the first quarter of 2020 and the impact of the adoption was not material to the Company's consolidated financial statements as credit losses are not expected to be significant based on historical collection trends, the financial condition of payment partners, and external market factors. The Company will continue to actively monitor the impact of the recent coronavirus (COVID-19) pandemic on expected credit losses. In addition, the new guidance requires us to record an allowance for credit loss when a decline in investment market value is due to credit-related factors. As of January 1, 2020, there was no material decline in the market value of available-for-sale investments due to credit-related factors.

In February 2018, the FASB issued guidance allowing a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the U.S. Tax Cuts and Jobs Act. The guidance is effective in fiscal year 2020, with early adoption permitted, including adoption in an interim period. If elected, the reclassification can be applied in either the period of adoption or retrospectively to the period of the enactment of the U.S. Tax Cuts and Jobs Act (i.e., our first quarter of fiscal year 2018). We adopted this guidance in the first quarter of 2020 and the impact of the adoption was not material to the Company's consolidated financial statements.

-10-


In August 2018, the FASB issued guidance related to fair value measurement disclosures. This guidance removes the requirement to disclose the amount of and reasons for transfers between Levels 1 and 2 of the fair value hierarchy, the policy for determining that a transfer has occurred, and valuation processes for Level 3 fair value measurements. Additionally, this guidance modifies the disclosures related to the measurement uncertainty for recurring Level 3 fair value measurements (by removing the requirement to disclose sensitivity to future changes) and the timing of liquidation of investee assets (by removing the timing requirement in certain instances). The guidance also requires new disclosures for Level 3 financial assets and liabilities, including the amount and location of unrealized gains and losses recognized in other comprehensive income(loss) and additional information related to significant unobservable inputs used in determining Level 3 fair value measurements. This guidance is effective beginning in fiscal year 2020. We adopted this guidance in the first quarter of 2020 and the impact of the adoption was not material to the Company's consolidated financial statements.

3. Business Combinations

CoreBiome and Novosanis

On January 4, 2019, the Company acquired all of the outstanding stock of CoreBiome, pursuant to the terms of a merger agreement, dated January 3, 2019. Also on January 4, 2019, the Company, through a wholly-owned subsidiary, acquired all of the outstanding stock of Novosanis, pursuant to a share purchase agreement, dated January 3, 2019. We began operating these entities as of the January 4, 2019 closing date. The aggregate purchase price for both of these transactions was $13,320 adjusted for certain transaction costs, indebtedness, and holdback amounts, and was funded with cash on hand. A portion of the purchase price was deposited into escrow accounts for a limited period after closing, in order to secure the potential payment of certain indemnification obligations of the selling stockholders under each agreement noted above.

During the three months ended March 31, 2019, we incurred a total of $597 of acquisition-related costs in connection with these acquisitions, including success-based investment banking fees and accounting, legal and other professional fees, related to both acquisitions, all of which were expensed and reported as a component of general and administrative expenses in the consolidated statement of operations for the three months ended March 31, 2019.

Pursuant to our acquisition agreements, we were to pay up to an additional $32,400 of contingent consideration over the next three years based on the achievement of certain performance criteria as defined under the agreements, including generating certain revenue dollars, the achievement of a large customer contract, and the development of certain new technology. The Company, with the assistance of an independent valuation specialist, utilized a Monte Carlo simulation to determine the estimated acquisition-date fair value of the acquisition-related contingent consideration of $4,350. The simulation calculated the probability-weighted payments based on our assessment of the likelihood that the benchmarks will be achieved. The probability-weighted payments were then discounted using a discount rate based on an internal rate of return analysis using the probability-weighted cash flows. The fair value measurement was based on significant inputs, including revenue forecasts, not observable in the market and thus represents a Level 3 measurement within the fair value hierarchy. The fair value of the contingent consideration obligation changed from $4,350 as of the acquisition date to $5,625 as of March 31, 2019 as a result of changes in our estimated revenue forecasts.  The fair value of the contingent consideration obligation changed from $3,612 as of December 31, 2019 to $1,220 as of March 31, 2020.  This change is a result of a $3,500 payment made in the first quarter of 2020, changes in our estimated revenue forecasts and an amendment to one of the agreements.  The amendment was entered into in March 2020, in which the terms of the contingent consideration provisions associated with one of the acquisitions were modified and are expected to be paid during the first quarter of 2021. As of March 31, 2020, we may pay up to an additional $22,500 of contingent consideration over the next year and a half.  

 

-11-


The following table summarizes the preliminary estimated fair values of the assets acquired and liabilities assumed as of the acquisition date:

 

Assets Acquired

 

 

 

 

Accounts receivable

 

$

791

 

Inventories

 

 

310

 

Other current assets

 

 

82

 

Property, plant, and equipment, net

 

 

414

 

Other assets

 

 

5

 

Acquired intangible assets

 

 

8,400

 

Goodwill

 

 

10,368

 

Total assets acquired

 

 

20,370

 

Liabilities Assumed

 

 

 

 

Current liabilities

 

 

1,180

 

Notes payable, short-term

 

 

730

 

Deferred tax liability

 

 

819

 

Other long-term liabilities

 

 

74

 

Total liabilities assumed

 

 

2,803

 

Net Assets Acquired

 

 

17,567

 

Estimated fair value of contingent consideration

 

 

(4,350

)

Net Cash Paid (net of cash acquired of $103)

 

$

13,217

 

 

The purchase price was allocated to the tangible assets and identifiable intangible assets acquired and liabilities assumed based on their acquisition-date estimate fair values. The identifiable intangible assets principally included developed technology, customer relationships, and tradenames, all of which are subject to amortization on a straight-line basis and are being amortized over estimated useful lives as summarized below:

 

 

 

Estimated Useful

 

 

 

 

Description

 

Life (in yrs)

 

Amount

 

Developed Technology

 

10

 

$

5,000

 

Customer relationships

 

10

 

 

2,200

 

Tradenames

 

8.34

 

 

1,200

 

Total acquired intangibles

 

 

 

$

8,400

 

 

The Company, with the assistance of an independent valuation specialist, assessed the fair value of the assets of CoreBiome and Novosanis. The income approach was used to value the acquired intangibles and the fair value measurements were primarily based on significant inputs that are not observable in the market and are considered Level 3 fair value measurements. The income approach estimates fair value for an asset based on the present value of cash flows projected to be generated by the asset.  Projected cash flows are discounted at a required rate of return that reflects the relative risk of achieving the cash flows and the time value of money.

The useful lives of the intangible assets were estimated based on the expected future economic benefit of the assets and are being amortized over the estimated useful life in proportion to the economic benefits consumed using the straight-line method.  The amortization of intangible assets is not deductible for income tax purposes.

 

Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the fair value of the net assets acquired, and represents the future economic benefits that we expect to achieve as a result of the acquisition. We believe the goodwill related to the acquisitions was a result of providing us a complementary service and product offering that will enable us to leverage those services and products with existing and new customers.  The goodwill is not deductible for income tax purposes.  All of the goodwill identified above has been allocated to our DNAG segment.

Revenues from CoreBiome primarily consist of microbiome laboratory services that utilize optimal analytical algorithms to deliver speed and scalability in the lab with precise analytics.  Revenues from Novosanis primarily consist of the sale of its Colli-Pee collection device which was designed for the standard collection of first-void urine used in the liquid biopsy and sexually transmitted infection screening market. Effective as of January 4, 2019, the financial results of CoreBiome and Novosanis are included in our DNAG segment.        

Diversigen

 

On November 8, 2019, the Company acquired all of the outstanding stock of Diversigen pursuant to the terms of a merger agreement. We began operating this entity as of the November 8, 2019 closing date.

-12-


 

The aggregate purchase price for this transaction was $12,000, adjusted for certain transaction costs, indebtedness, and holdback amounts, and was funded with cash on hand. A portion of the purchase price was deposited into an escrow account for a limited period after closing, pursuant to indemnification obligations under the merger agreement noted above.  

 

During the three months ended March 31, 2020 and 2019, we did not incur any acquisition related costs associated with this transaction, including investment banking fees and accounting, legal and other professional fees.

Pursuant to our acquisition agreements, we were to pay up to an additional $1,500 of contingent consideration in 2020 based on the achievement of certain 2019 revenue metrics as defined under the agreements which did not occur. 

The following table summarizes the preliminary estimated fair values of the assets acquired and liabilities assumed as of the acquisition date:

Assets Acquired

 

 

 

 

Accounts receivable

 

$

1,234

 

Other current assets

 

 

45

 

Property, plant, and equipment, net

 

 

1,916

 

Acquired intangible assets

 

 

3,560

 

Goodwill

 

 

6,317

 

Total assets acquired

 

 

13,072

 

Liabilities Assumed

 

 

 

 

Current liabilities

 

 

1,123

 

Deferred tax liability

 

 

598

 

Other long-term liabilities

 

 

893

 

Total liabilities assumed

 

 

2,614

 

Net Cash Paid (net of cash acquired of $479)

 

$

10,458

 

The purchase price was allocated to the tangible assets and identifiable intangible assets acquired and liabilities assumed based on their acquisition-date estimate fair values. The identifiable intangible assets included customer relationships and tradenames, all of which are subject to amortization on a straight-line basis and are being amortized over estimated useful lives as summarized below:

 

 

Estimated Useful

 

 

 

 

Description

 

Life (in yrs)

 

Amount

 

Customer relationships

 

10

 

 

2,900

 

Tradenames

 

9

 

 

660

 

Total acquired intangibles

 

 

 

$

3,560

 

 

The Company, with the assistance of an independent valuation specialist, assessed the fair value of the assets of Diversigen. The income approach was used to value the acquired intangibles and the fair value measurements were primarily based on significant inputs that are not observable in the market and are considered Level 3 fair value measurements. The income approach estimates fair value for an asset based on the present value of cash flows projected to be generated by the asset.  Projected cash flows are discounted at a required rate of return that reflects the relative risk of achieving the cash flows and the time value of money.

The useful lives of the intangible assets were estimated based on the expected future economic benefit of the assets and are being amortized over the estimated useful life in proportion to the economic benefits consumed using the straight-line method.  The amortization of intangible assets is not deductible for income tax purposes.

Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the fair value of the net assets acquired, and represents the future economic benefits that we expect to achieve as a result of the acquisition. We believe the goodwill related to the acquisitions was a result of providing us a complementary service and product offering that will enable us to leverage those services and products with existing and new customers.  The goodwill is not deductible for income tax purposes.  All of the goodwill identified above has been allocated to our DNAG segment.

We continue to evaluate the fair value of certain assets acquired and liabilities assumed. Additional information, which existed as of the acquisition date, but was at that time unknown to us, may become known during the remainder of the measurement period. Changes to amounts recorded as a result of the final determination may result in a corresponding adjustment to these assets and liabilities, including goodwill. The determination of the estimated fair values of all assets acquired is expected to be completed within one year from the date of acquisition.

Revenues from Diversigen primarily consist of microbiome laboratory services that provide metagenomics sequencing, bioinformatics and statistical analysis for the study of the microbiome. Effective as of November 8, 2019, the financial results of Diversigen are included in our DNAG segment.     

-13-


Unaudited Pro Forma Financial Information

The unaudited pro forma results presented below include the results of the CoreBiome, Diversigen and Novosanis acquisitions as if they had been consummated as of January 1, 2019. The unaudited pro forma results include the amortization associated with acquired intangible assets and the estimated tax effect of adjustments to income before income taxes but do not include changes in the fair value of our contingent consideration obligations. Material nonrecurring charges, directly attributable to the transactions, including direct acquisition costs, are also excluded. In addition, the unaudited pro forma results do not include any expected benefits of the acquisitions. Accordingly, the unaudited pro forma results are not necessarily indicative of either future results of operations or results that might have been achieved had the acquisitions been consummated as of January 1, 2019.

 

 

Three Months ended

 

 

 

March 31, 2019

 

 

 

 

 

 

Revenue

 

$

31,048

 

Net loss

 

 

(3,290

)

Net loss per share, basic and diluted

 

 

(0.05

)

 

4.

Revenues

Revenues by product.  The following table represents total net revenues by product line:

 

 

 

Three Months Ended March 31,

 

 

2020

 

 

2019

 

 

OraQuick®

 

$

13,756

 

 

$

11,590

 

 

Oragene®

 

 

9,633

 

 

 

4,173

 

 

ORAcollect®

 

 

449

 

 

 

3,225

 

 

Intercept®

 

 

1,978

 

 

 

1,842

 

 

Microbiome laboratory services

 

 

2,447

 

 

 

958

 

 

OMNIgene® • GUT

 

 

693

 

 

 

979

 

 

Histofreezer® (1)

 

 

-

 

 

 

2,213

 

 

Other products

 

 

1,930

 

 

 

3,352

 

 

Net product and services revenues

 

 

30,886

 

 

 

28,332

 

 

 

 

 

 

 

 

 

 

 

 

Royalty income

 

 

446

 

 

 

1,084

 

 

Other non product revenues

 

 

264

 

 

 

706

 

 

Other revenues

 

 

710

 

 

 

1,790

 

 

Net revenues

 

$

31,596

 

 

$

30,122

 

 

 

 

(1)

On August 16, 2019, we sold all rights and title to the assets necessary to operate our cryosurgical line of business and as such results of operations after August 16, 2019, do not include any revenues associated with that line of business.

 

Revenues by geographic area.  The following table represents total net revenues by geographic area, based on the location of the customer:

 

 

 

 

Three Months Ended March 31,

 

 

 

 

2020

 

 

2019

 

United States

 

 

$

21,616

 

 

$

20,566

 

Europe

 

 

 

2,805

 

 

 

2,431

 

Other regions

 

 

 

7,175

 

 

 

7,125

 

 

 

 

$

31,596

 

 

$

30,122

 

 

Customer and Vendor Concentrations. One of our customers accounted for 12% of our accounts receivable as of March 31, 2020. Another customer accounted for 19% of our accounts receivable as of December 31, 2019. We had no significant customer concentrations (greater than 10%) in our net consolidated revenues for the three months ended March 31, 2020 and 2019           

 

We currently purchase certain products and critical components of our products from sole-supply vendors. If these vendors are unable or unwilling to supply the required components and products, we could be subject to increased costs and substantial delays in the delivery of our products to our customers. Also, our subsidiary, DNAG, uses two third-party suppliers to manufacture its product. Our inability to have a timely supply of any of these components and products could have a material adverse effect on our business, as well as our financial condition and results of operations.

-14-


Deferred Revenue.  We record deferred revenue when funds are received prior to the recognition of the associated revenue.  Deferred revenue as of March 31, 2020 and December 31, 2019 includes customer prepayments of $2,508 and $1,904, respectively.  Deferred revenue as of March 31, 2020 and December 31, 2019 also includes $ 1,804 and $1,809, respectively, associated with a long-term contract that has variable pricing based on volume. The average price over the life of the contract was determined and revenue is recognized at that rate.

5.

Accrued Expenses and other current liabilities

 

 

 

March 31, 2020

 

 

December 31, 2019

 

Payroll and related benefits

 

$

5,414

 

 

$

6,088

 

Professional fees

 

 

2,364

 

 

 

2,769

 

Other

 

 

4,561

 

 

 

5,431

 

 

 

$

12,339

 

 

$

14,288

 

 

6.

Leases

We determine whether an arrangement is a lease at inception. We have operating and finance leases for corporate offices, warehouse space and equipment (including vehicles). As of March 31, 2020, we are the lessee in all agreements. Our leases have remaining lease terms of 1 to 7 years, some of which include options to extend the leases based on agreed upon terms, and some of which include options to terminate the leases within 1 year.

As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments.

We have lease agreements that contain both lease and non-lease components (e.g., common-area maintenance). For these agreements, we account for lease components separate from non-lease components.

The components of lease expense are as follows:

 

 

Three Months Ended March 31,

 

 

 

2020

 

 

2019

 

Operating Lease Cost

 

$

313

 

 

$

231

 

Finance Lease Cost

 

 

 

 

 

 

 

 

    Amortization of right-of use assets

 

 

163

 

 

 

39

 

    Interest on lease liabilities

 

 

20

 

 

 

4

 

Total Finance Lease Cost

 

$

183

 

 

$

43

 

 

 

 

 

 

 

 

 

 

   

Supplemental cash flow information related to leases is as follows:

 

 

Three Months Ended March 31,

 

 

 

2020

 

 

2019

 

Cash paid for amounts included in the measurement of lease liabilities:

 

 

 

 

 

 

 

 

Operating cash flows from operating leases

 

$

316

 

 

$

228

 

Operating cash flows from financing leases

 

 

20

 

 

 

3

 

Financing cash flows from financing leases

 

 

175

 

 

 

35

 

Non-cash activity

 

 

 

 

 

 

 

 

Right-of-use assets obtained in exchange for operating lease obligations

 

 

 

 

 

240

 

Right-of-use assets obtained in exchange for finance lease obligations

 

 

 

 

 

1,249

 

 

-15-


Supplemental balance sheet information related to leases is as follows:

 

 

March 31, 2020

 

 

December 31, 2019

 

Operating Leases

 

 

 

 

 

 

 

 

Right-of-use assets

 

$

4,665

 

 

$

4,996

 

 

 

 

 

 

 

 

 

 

Current lease liabilities

 

 

999

 

 

 

1,032

 

Non-current lease liabilities

 

 

3,899

 

 

 

4,206

 

   Total operating lease liabilities

 

$

4,898

 

 

$

5,238

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Finance Leases

 

 

 

 

 

 

 

 

Right-of-use assets

 

$

1,818

 

 

$

1,951

 

 

 

 

 

 

 

 

 

 

Current lease liabilities

 

 

588

 

 

 

613

 

Non-current lease liabilities

 

 

1,281

 

 

 

1,372

 

   Total finance lease liabilities

 

$

1,869

 

 

$

1,985

 

 

Weighted Average Remaining Lease Term

 

 

 

 

Weighted-average remaining lease term—operating leases

 

 

5.05

 

Weighted-average remaining lease term—finance leases

 

 

3.27

 

 

 

 

 

 

Weighted Average Discount Rate

 

 

 

 

Weighted-average discount rate—operating leases

 

 

4.29

%

Weighted-average discount rate—finance leases

 

 

4.32

%

 

As of March 31, 2020, minimum lease payments by period are expected to be as follows:

 

 

 

 

 

 

 

 

 

Finance

 

 

Operating

 

2020 (excluding the three months ended March 31, 2020)

$

512

 

 

$

928

 

2021

 

565

 

 

 

1,180

 

2022

 

565

 

 

 

1,161

 

2023

 

336

 

 

 

758

 

2024

 

24

 

 

 

776

 

Thereafter

 

4

 

 

 

760

 

Total Minimum Lease Payments

 

2,006

 

 

 

5,563

 

Less: imputed interest

 

(137

)

 

 

(665

)

Present Value of Lease Liabilities

$

1,869

 

 

$

4,898

 

 

 

 

 

-16-


7.

Stockholders’ Equity

 

Reconciliation of the changes in stockholders' equity for the three months ended March 31, 2020 and 2019

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Total

 

Balance at December 31, 2019

 

 

61,731

 

 

$

 

 

$

401,814

 

 

$

(12,136

)

 

$

(82,533

)

 

$

307,145

 

Common stock issued upon exercise

   of options

 

 

6

 

 

 

 

 

 

30

 

 

 

 

 

 

 

 

 

30

 

Vesting of restricted stock and performance stock units

 

 

486

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase and retirement of common shares

 

 

(197

)

 

 

 

 

 

(1,408

)

 

 

 

 

 

 

 

 

(1,408

)

Stock-based compensation

 

 

 

 

 

 

 

 

1,376

 

 

 

 

 

 

 

 

 

1,376

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,328

)

 

 

(7,328

)

Currency translation adjustments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,221

)

 

 

 

 

 

 

(9,221

)

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

 

(442

)

 

 

 

 

 

(442

)

Balance at March 31, 2020

 

 

62,026

 

 

$

 

 

$

401,812

 

 

$

(21,799

)

 

$

(89,861

)

 

$

290,152

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Total

 

Balance at December 31, 2018

 

 

61,276

 

 

$

 

 

$

401,273

 

 

$

(18,706

)

 

$

(99,189

)

 

$

283,378

 

Common stock issued upon exercise

   of options

 

 

4

 

 

 

 

 

 

22

 

 

 

 

 

 

 

 

 

22

 

Vesting of restricted stock and performance stock units

 

 

664

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase and retirement of common shares

 

 

(277

)

 

 

 

 

 

(3,595

)

 

 

 

 

 

 

 

 

(3,595

)

Stock-based compensation

 

 

 

 

 

 

 

 

1,231

 

 

 

 

 

 

 

 

 

1,231

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,258

)

 

 

(3,258

)

Currency translation adjustments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,232

 

 

 

 

 

 

 

2,232

 

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

 

497

 

 

 

 

 

 

497

 

Balance at March 31, 2019

 

 

61,667

 

 

$

 

 

$

398,931

 

 

$

(15,977

)

 

$

(102,447

)

 

$

280,507

 

 

Stock-Based Awards

We grant stock-based awards under the OraSure Technologies, Inc. Stock Award Plan, as amended (the “Stock Plan”). The Stock Plan permits stock-based awards to employees, outside directors and consultants or other third-party advisors. Awards which may be granted under the Stock Plan include qualified incentive stock options, nonqualified stock options, stock appreciation rights, restricted awards, performance awards and other stock-based awards. We account for stock-based compensation to employees and directors using the fair value method. We recognize compensation expense for stock option and restricted stock awards issued to employees and directors on a straight-line basis over the requisite service period of the award. We recognize compensation expense related to performance-based restricted stock units based on assumptions as to what percentage of each performance target will be achieved. We evaluate these target assumptions on a quarterly basis and adjust compensation expense related to these awards, as appropriate. To satisfy the exercise of options, issuance of restricted stock, or redemption of performance-based restricted stock units, we issue new shares rather than shares purchased on the open market.

Total compensation cost related to stock options for the three months ended March 31, 2020 and 2019 was $253 and $324 respectively. Net cash proceeds from the exercise of stock options were $30 and $22 for the three months ended March 31, 2020 and 2019, respectively. As a result of our net operating loss carryforward position, no actual income tax benefit was realized from stock option exercises during these periods.

The following table summarizes the stock option activity for the three months ended March 31, 2020:

  

 

Options

 

Outstanding on January 1, 2020

 

 

1,193

 

Granted

 

 

510

 

Exercised

 

 

(6

)

Forfeited

 

 

(14

)

Outstanding on March 31, 2020

 

 

1,683

 

-17-


 

Compensation cost of $1,079 and $653 related to restricted shares was recognized during the three months ended March 31, 2020 and 2019, respectively. In connection with the vesting of restricted shares during the three months ended March 31, 2020 and 2019, we purchased and immediately retired 197 and 277 shares with aggregate values of $1,408 and $3,595, respectively, in satisfaction of minimum tax withholding obligations.

 

The following table summarizes time-vested restricted stock award and restricted stock unit activity for the three months ended March 31, 2020:

 

 

Units

 

Issued and unvested, January 1, 2020

 

 

464

 

Granted

 

 

480

 

Vested

 

 

(178

)

Forfeited

 

 

(10

)

Issued and unvested, March 31, 2020

 

 

756

 

 

We grant performance-based restricted stock units (“PSUs”) to certain executives. Vesting of these PSUs is dependent upon achievement of performance-based metrics during a one-year or three-year period from the date of grant. Assuming achievement of each performance-based metric, the executive must also generally remain in our service for three years from the grant date. Performance during the one-year period is based on a one-year earnings per share or income before income taxes target. If the one-year target is achieved, the PSUs will then vest three years from grant date. Performance during the three-year period will be based on achievement of a three-year compound annual growth rate for consolidated product revenues. If the three-year target is achieved, the corresponding PSUs will then vest three years from grant date. PSUs are converted into shares of our common stock once vested.

Compensation cost of $44 and $254 related to PSUs was recognized during the three months ended March 31, 2020 and 2019, respectively.

The following table summarizes the PSU activity for the three months ended March 31, 2020:  

  

 

Units

 

Issued and unvested, January 1, 2020

 

 

525

 

Granted

 

 

353

 

Performance adjustment

 

 

103

 

Vested

 

 

(311

)

Forfeited

 

 

(35

)

Issued and unvested, March 31, 2020

 

 

635

 

 Stock Repurchase Program

On August 5, 2008, our Board of Directors approved a share repurchase program pursuant to which we are permitted to acquire up to $25,000 of our outstanding common shares. No shares were purchased and retired during the three months ended March 31, 2020 and 2019.   

8.

Income Taxes

During the three months ended March 31, 2020, we recorded income tax expense of $712 which primarily consists of foreign tax expense.  During the three months ended March 31, 2019, we recorded and income tax benefit of $29 which primarily consists of a foreign tax benefit offset by nominal domestic tax expense.

Tax expense reflects taxes due to the taxing authorities and the tax effects of temporary differences between the basis of assets and liabilities recognized for financial reporting and tax purposes, and net operating loss and tax credit carryforwards. The significant components of our total deferred tax liability as of March 31, 2020 and December 31, 2019 relate to the tax effects of the basis difference between the intangible assets acquired in our acquisitions for financial reporting and for tax purposes.

In 2008, we established a full valuation allowance against our U.S. deferred tax asset. Management believes the full valuation allowance is still appropriate at both March 31, 2020 and December 31, 2019 since the facts and circumstances necessitating the allowance have not changed. As a result, no U.S. federal or state deferred income tax expense or benefit was recorded for the three month period ended March 31, 2020.

9.

Commitments and Contingencies

From time to time, we are involved in certain legal actions arising in the ordinary course of business. In management’s opinion, the outcomes of such actions, either individually or in the aggregate, are not expected to have a material adverse effect on our future financial position or results of operations.

-18-


10.

Business Segment Information

Our business consists of two segments: our “OSUR” business consists of the development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices using our proprietary technologies, other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. Our DNAG business consists of the development, manufacture, marketing and sale of specimen collection kits that are used to collect, stabilize, transport and store samples of genetic material for molecular testing. Our collection kits are also used for the collection of first-void urine for liquid biopsy in the prostate and bladder cancer markets; and in the sexually transmitted infection screening market. In addition, our DNAG business provides microbiome laboratory services that accelerate research and discovery for customers in the pharmaceutical, agricultural, and academic research markets. Financial results of CoreBiome, Novosanis and Diversigen are included in our DNAG segment. Our cryosurgical systems business was included in our OSUR segment and the impact of the sale of that business in August 2019 is reflected in the results presented below. 

We organized our operating segments according to the nature of the products included in those segments. The accounting policies of the segments are the same as those described in the summary of significant accounting policies (see Note 2). We evaluate performance of our operating segments based on revenue and operating income. We do not allocate interest income, interest expense, other income, other expenses or income taxes to our operating segments. Reportable segments have no inter-segment revenues and inter-segment expenses have been eliminated.

The following table summarizes operating segment information for the three months ended March 31, 2020 and 2019, and asset information as of March 31, 2020 and December 31, 2019:

 

 

 

Three Months Ended March 31,

 

 

 

2020

 

 

2019

 

Net revenues:

 

 

 

 

 

 

 

 

OSUR

 

$

17,792

 

 

$

18,233

 

DNAG

 

 

13,804

 

 

 

11,889

 

Total

 

$

31,596

 

 

$

30,122

 

Operating loss:

 

 

 

 

 

 

 

 

OSUR

 

$

(7,641

)

 

$

(3,499

)

DNAG

 

 

(405

)

 

 

(312

)

Total

 

$

(8,046

)

 

$

(3,811

)

Depreciation and amortization:

 

 

 

 

 

 

 

 

OSUR

 

$

861

 

 

$

822

 

DNAG

 

 

1,336

 

 

 

904

 

Total

 

$

2,197

 

 

$

1,726

 

Capital expenditures:

 

 

 

 

 

 

 

 

OSUR

 

$

818

 

 

$

1,929

 

DNAG

 

 

1,777

 

 

 

699

 

Total

 

$

2,595

 

 

$

2,628

 

 

 

 

 

March 31, 2020

 

 

December 31, 2019

 

Total assets:

 

 

 

 

 

 

 

 

OSUR

 

$

174,197

 

 

$

163,943

 

DNAG

 

 

150,875

 

 

 

185,352

 

Total

 

$

325,072

 

 

$

349,295

 

 

-19-


Item 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Statements below regarding future events or performance are “forward-looking statements” within the meaning of the Federal securities laws. These may include statements about our expected revenues, earnings, losses, expenses, or other financial performance, future product performance or development, expected regulatory filings and approvals, planned business transactions, expected manufacturing performance, views of future industry, competitive or market conditions, and other factors that could affect our future operations, results of operations or financial position. These statements often include words such as “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates,” “may,” “will,” “should,” “could,” or similar expressions. 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 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 our business and our ability to successfully develop new products, validate the expanded use of existing collector products and commercialize such products for COVID-19 testing; 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, 2019, 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 Report, and we undertake no duty to update these statements.

Investors should also be aware that while we do, from time to time, communicate with securities analysts, it is against our policy to disclose any material non-public information or other confidential commercial information. Accordingly, stockholders should not assume that we agree with any statement or report issued by any analyst irrespective of the content of the statement or report. Furthermore, we have a policy against issuing or confirming financial forecasts or projections issued by others. Thus, to the extent that reports issued by securities analysts contain any projections, forecasts or opinions, such reports are not the responsibility of OraSure.

The following discussion should be read in conjunction with our consolidated financial statements contained herein and the notes thereto, along with the Section entitled “Critical Accounting Policies and Estimates,” set forth below.


-20-


Overview and Business Segments

 

Our business consists of two segments: our “OSUR” business consists of the development, manufacture, marketing and sale of oral fluid diagnostic products and specimen collection devices using our proprietary technologies, other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. Our DNAG business consists of the manufacture and sale of kits that are used to collect, stabilize, transport and store biological samples of genetic material for molecular testing. Our collection kits are also used for the collection of first-void urine for liquid biopsy in the prostate and bladder cancer markets; and in the sexually transmitted infection screening market. In addition, our DNAG business provides microbiome laboratory and bioinformatics services. The DNAG segment also includes genomic and microbiome laboratory testing and analytical services.

Our OSUR diagnostic products include tests for diseases including HIV and Hepatitis C that are performed on a rapid basis at the point of care and tests that are processed in a laboratory. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. Our HIV product is also sold in a consumer-friendly format in the OTC and public health markets in the U.S. and as a self-test to individuals in a number of other countries. We also previously manufactured and sold medical devices used for the removal of benign skin lesions by cryosurgery or freezing. These cryosurgical products were sold in both professional and OTC markets in North America, Europe, Central and South America, and Australia. We sold the assets associated with our cryosurgical systems business to a third party in August 2019.    

Our DNAG business is operated by our subsidiaries, DNAG, CoreBiome, Novosanis and Diversigen. DNAG’s specimen collection devices provide all-in-one systems for the collection, stabilization, transportation and storage of nucleic acids from human saliva and other biological sample types for genetic and microbiome applications. Our products are used for academic research and commercial applications, including ancestry, disease risk management, lifestyle and animal testing.  Included in the disease risk management area are pharmacogenomics testing, hereditary disease screening, prenatal or cancer screening, population health initiatives and other molecular testing in DNA or RNA for the diagnosis of acute disease.  CoreBiome and Diversigen provide the laboratory testing and bioinformatics services. Novosanis’ Colli-Pee collection device is designed for the volumetric collection of first-void urine for use in research, screening and diagnostics for the liquid biopsy and sexually transmitted infection markets. We also sell research use only sample collection products into the microbiome market and we offer our customers a suite of genomics and microbiome services, which range from package customization and study design optimization to extraction, analysis and reporting services. We serve customers worldwide in the research, healthcare, pharmaceutical and agricultural communities.  

Recent Developments

Impact of COVID-19

In March 2020, the World Health Organization declared the novel coronavirus (“COVID-19”) a global pandemic.  This contagious disease outbreak, which has continued to spread, and any related adverse public health developments, has adversely affected workforces, economies, and financial markets globally, potentially leading to an economic downturn. It is not possible for the Company to predict the duration or magnitude of the outbreak’s effects on the Company’s business or results of operations at this time.

 

During the first quarter of 2020, traditional HIV and HCV testing programs and drug testing in the workplace market began to be reduced or terminated as a result of the various “stay-at-home” orders and social distancing guidelines issued by federal, state and local governments to contain the spread of the COVID-19 pandemic in the United States.  On the international front, during the first quarter of 2020, we experienced some delays with international shipments due to a reduction of customs and transportation personnel, a reduced number of air flights and shipping congestion.  In our molecular segment, clinical and research work during the first quarter, particularly in the academic market, has reduced demand for our products.  Although these trends did not materially impact our first quarter 2020 financial results, we believe they will continue and will have a greater adverse impact on the revenues of certain parts of our business for an indeterminate time period, depending on the duration and severity of the COVID-19 pandemic.

 

Despite the expected negative impacts from COVID-19, we also believe there are potentially significant opportunities for increased revenues as a result of the pandemic.  In the U.S., public health customers are purchasing increased quantities of our OraQuick® In-Home HIV Test in order to permit continued HIV testing while allowing clients and patients to adhere to “stay-at-home” and social distancing requirements.  In addition, we are seeing increased demand for our molecular collection products from customers who conduct both saliva and blood-based testing. As it becomes increasingly difficult to collect blood in clinics or healthcare settings, these customers are increasingly relying on the saliva collection alternative.  As described below, we are also developing new tests for coronavirus and are working to validate the use of a number of our existing molecular collection products for use in COVID-19 testing.  If we are successful in these efforts, we believe these new products and the expanded use of our existing products could result in significant additional revenues that could potentially offset or exceed the lost revenues expected in other parts of our business as a result of the COVID-19 pandemic.

 

COVID-19 Product Development

In April 2020, we were awarded a contract for $710,310 in funding from the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority (“BARDA”) to develop a

-21-


pan-SARS-coronavirus rapid in-home self-test that uses oral fluid samples and that will be based on our OraQuick® platform which currently supports HIV, HCV, and Ebola testing. This support from BARDA will enable the Company to file for FDA Emergency Use Authorization allowing for an in-home self-test to debut into the U.S. market. In addition to a rapid coronavirus antigen self-test, we are developing a lab-based oral fluid microplate coronavirus antibody enzyme-linked immunosorbent assay (ELISA).

 

We are also actively engaged with several laboratories and researchers to demonstrate the effectiveness of our existing products for use with coronavirus testing. Recent publications show that the coronavirus can be successfully detected in saliva. The stabilization solution in our molecular collection products can accommodate a very broad spectrum of microbiome activity spanning bacteria to viruses and we are collecting data on the usability of our kits for this purpose.  Although we understand that the current standard for collecting COVID-19 samples is with a nasopharyngeal or oropharyngeal swab, we believe that oral samples collected using devices from our product lines for liquid saliva or oral swab samples could be a suitable alternative. Unlike nasopharyngeal and oropharyngeal swabs which cannot be self-administered, our products are optimized for self-collection. That means healthcare providers, retailers, and online vendors could ship our kits directly to an individual’s home, eliminating unnecessary trips to hospitals, doctors’ offices and testing facilities. Self-collection would support the social distancing guidelines already in place in many communities, reduce the burden on testing sites and healthcare facilities, provide wider access to testing and curb the spread of virus.

 

Moreover, the chemistry in our products stabilizes nucleic acids, including RNA, which is the nucleic acid used by most labs for COVID-19 testing. The usability and form factor of these products are ideal for use in at-home or clinic settings. Should the data support the use of our existing products for COVID-19 diagnostics, additional avenues of sample collection will be enabled. We expect to receive this data in the near future as this validation requires paired sampling from infected patients.  

Current Consolidated Financial Results

During the three months ended March 31, 2020, our consolidated net revenues increased 5% to $31.6 million, compared to $30.1 million for the three months ended March 31, 2019. Net product and services revenues during the three months ended March 31, 2020 increased 9% when compared to the same period of 2019, primarily due to higher international sales of our OraQuick® HIV Self-Test, higher sales of our genomics products, and increased laboratory service revenues. Partially offsetting these increases were lower sales of our domestic and international HCV products and the absence of cryosurgical sales as a result of the divestiture of our cryosurgical systems business in August 2019. Other revenues for the three months ended March 31, 2020 were $710,000 compared to $1.8 million in the same period of 2019. This decline is largely due to lower royalty income.

Our consolidated net loss for the three months ended March 31, 2020 was $7.3 million or $0.12 per share on a fully diluted basis, compared to consolidated net loss of $3.3 million, or $0.05 per share on a fully diluted basis, for the three months ended March 31, 2019. Results for the three months ended March 31, 2020 included a $1.1 million non-cash pre-tax charge associated with the change in the fair value of acquisition-related contingent consideration, which approximated $0.02 per share. Results in the first quarter of 2019 included $1.3 million of a non-cash pre-tax charge associated with the change in the fair value of our acquisition-related contingent consideration and $597,000 of acquisition-related transaction costs.  The combined impact of these charges reduced our fully diluted earnings per share by approximately $0.03.  

Cash provided by operating activities during the three months ended March 31, 2020 was $2.5 million. Cash provided by operating activities during the three months ended March 31, 2019 was $528,000. As of March 31, 2020, we had $176.2 million in cash, cash equivalents, and available-for-sale securities, compared to $189.8 million at December 31, 2019.

Results of Operations

Three months ended March 31, 2020 compared to March 31, 2019

CONSOLIDATED NET REVENUES

The table below shows a breakdown of total consolidated net revenues (dollars in thousands) generated by each of our business segments for the three months ended March 31, 2020 and 2019.

 

 

 

Three Months Ended March 31,

 

 

 

 

Dollars

 

 

 

 

 

 

 

Percentage of Total Net Revenues

 

 

 

 

2020

 

 

2019

 

 

% Change

 

 

 

2020

 

 

 

2019

 

 

OSUR

 

$

17,664

 

 

$

17,749

 

 

 

 

%

 

 

56

 

%

 

 

59

 

%

DNAG

 

 

13,222

 

 

 

10,583

 

 

 

25

 

 

 

 

42

 

 

 

 

35

 

 

Net product and services revenues

 

 

30,886

 

 

 

28,332

 

 

 

9

 

 

 

 

98

 

 

 

 

94

 

 

Other

 

 

710

 

 

 

1,790

 

 

 

(60

)

 

 

 

2

 

 

 

 

6

 

 

Net revenues

 

$

31,596

 

 

$

30,122

 

 

 

5

 

%

 

 

100

 

%

 

 

100

 

%

 

-22-


Consolidated net product and services revenues increased 9% to $30.9 million in the first quarter of 2020 from $28.3 million in the comparable period of 2019. Higher sales of our international HIV and genomics products and higher laboratory services revenues were partially offset by lower domestic and international OraQuick® HCV sales and the absence of cryosurgical systems revenues due to the sale of our cryosurgical systems business in August 2019. Other revenues for the first quarter of 2020 were $710,000 compared to $1.8 million in the same period of 2019. Other revenues in the first quarter of 2020 included $446,000 in royalty income earned under a litigation settlement agreement and other revenues of $264,000 associated with funded research and development, reimbursement of certain costs under our charitable support agreement with the Gates Foundation, and grant revenue. Other revenues in the first quarter of 2019 included $1.1 million in royalty income earned under a litigation settlement agreement and $706,000 in research and development funding, reimbursement of certain costs under our charitable support agreement with the Gates Foundation, and grant revenue. 

Consolidated net revenues derived from products sold to customers outside of the United States were $10.0 million and $9.6 million, or 32% of total net revenues, in the first quarters of 2020 and 2019, respectively. Because the majority of our international sales are denominated in U.S. dollars, the impact of fluctuating foreign currency exchange rates was not material to our total consolidated net revenues.

Net Revenues by Segment

OSUR Segment

The table below shows a breakdown of total net revenues (dollars in thousands) generated by our OSUR segment during the first quarters of 2020 and 2019.

 

 

 

Three Months Ended March 31,

 

 

 

 

Dollars

 

 

 

 

 

 

 

Percentage of Total Net Revenues

 

 

Market

 

2020

 

 

2019

 

 

% Change

 

 

 

2020

 

 

 

2019

 

 

Infectious disease testing

 

$

14,664

 

 

$

12,338

 

 

 

19

 

%

 

 

82

 

%

 

 

67

 

%

Risk assessment testing

 

 

3,000

 

 

 

2,836

 

 

 

6

 

 

 

 

17

 

 

 

 

16

 

 

Cryosurgical systems

 

 

 

 

 

2,575

 

 

 

(100

)

 

 

 

 

 

 

 

14

 

 

Net product revenues

 

 

17,664

 

 

 

17,749

 

 

 

 

 

 

 

99

 

 

 

 

97

 

 

Other

 

 

128

 

 

 

484

 

 

 

(74

)

 

 

 

1

 

 

 

 

3

 

 

Net revenues

 

$

17,792

 

 

$

18,233

 

 

 

(2

)

%

 

 

100

 

%

 

 

100

 

%

 

Infectious Disease Testing Market

Sales to the infectious disease testing market increased 19% to $14.7 million in the first quarter of 2020 from $12.3 million in the first quarter of 2019. This increase resulted from higher international sales of our OraQuick® HIV products, partially offset by lower domestic sales of our OraQuick® HIV products and lower world-wide sales of our OraQuick® HCV products.

The table below shows a breakdown of our total net OraQuick® HIV and HCV product revenues (dollars in thousands) during the first quarters of 2020 and 2019.

 

 

 

Three Months Ended March 31,

 

 

Market

 

2020

 

 

2019

 

 

% Change

 

 

Domestic HIV

 

$

4,216

 

 

$

4,304

 

 

 

(2

)

%

International HIV

 

 

6,949

 

 

 

4,001

 

 

 

74

 

 

Net HIV revenues

 

 

11,165

 

 

 

8,305

 

 

 

34

 

 

Domestic HCV

 

 

1,494

 

 

 

1,828

 

 

 

(18

)

 

International HCV

 

 

1,097

 

 

 

1,457

 

 

 

(25

)

 

Net HCV revenues

 

 

2,591

 

 

 

3,285

 

 

 

(21

)

 

Net OraQuick®  revenues

 

$

13,756

 

 

$

11,590

 

 

 

19

 

%

 

Domestic OraQuick® HIV sales decreased 2% to $4.2 million for the three months ended March 31, 2020 from $4.3 million for the three months ended March 31, 2019. This decrease was primarily the result of lower sales of our professional product due to price and fourth generation test competition partially offset by higher sales of our over-the-counter product as a result of a stocking order at a new retailer.  

International sales of our OraQuick® HIV tests increased 74% to $6.9 million for the three months ended March 31, 2020 from $4.0 million for the three months ended March 31, 2019. This increase was largely due to higher sales of our OraQuick® HIV Self-Test in Africa.

Domestic OraQuick® HCV sales decreased 18% to $1.5 million in the first quarter of 2020 from $1.8 million in the first quarter of 2019 primarily due to a decline in public health funding as funds were redirected to COVID-19 testing and due to the closure of testing programs to comply with the national stay at-home orders associated with the COVID-19 pandemic.

-23-


International OraQuick® HCV sales decreased 25% to $1.1 million in the first quarter of 2020 from $1.5 million in the first quarter of 2019 due to lower sales in Asia.

Risk Assessment Market

Sales to the risk assessment market increased 6% to $3.0 million in the first quarter of 2020 compared to $2.8 million in the first quarter of 2019 due to increased pre-employment drug testing.

Cryosurgical Systems Market

In August 2019, we sold our cryosurgical systems line of business and as such have stopped recording revenues associated with that business since the third quarter of 2019.

Other revenues

Other revenues in the first quarter of 2020 decreased 74% to $128,000 from $484,000 of other revenues recorded in the first quarter of 2019. Revenue associated with funding of our research and development efforts declined to $104,000 in the first quarter of 2020 from $364,000 in the first quarter of 2019 as a result of the wind-down of our development efforts on our rapid Ebola test.  Other revenues in the first quarter of 2020 also included $24,000 in reimbursement of certain costs under our charitable support agreement with the Gates Foundation compared to $120,000 in the first quarter of 2019.

DNAG Segment

The table below shows a breakdown of our total net revenues (dollars in thousands) during the first quarters of 2020 and 2019.

 

 

 

Three Months Ended March 31,

 

 

Market

2020

 

 

2019

 

 

% Change

 

 

Genomics

 

$

9,135

 

 

$

8,047

 

 

 

14

 

%

Microbiome

 

 

1,645

 

 

 

1,609

 

 

 

2

 

 

Other product revenues

 

 

27

 

 

 

210

 

 

 

(87

)

 

Laboratory services

 

 

2,415

 

 

 

717

 

 

 

237

 

 

Net molecular product and services revenues

 

$

13,222

 

 

$

10,583

 

 

 

25

 

 

Other

 

 

582

 

 

 

1,306

 

 

 

(55

)

 

Net molecular product and services revenues

 

$

13,804

 

 

$

11,889

 

 

 

16

 

%

 

Sales of our genomics products increased 14% to $9.1 million in the first quarter of 2020 compared to $8.0 million in the first quarter of 2019, largely due to organic growth of existing customers and a shift from blood to saliva collection by customers using both sample types due to the inability to collect blood samples as a result of restrictions related to COVID-19.

Microbiome sales largely remained consistent at $1.6 million in the first quarters of 2020 and 2019.  

 

Laboratory services revenues increased 237% to $2.4 million in the first quarter of 2020 compared to $717,000 in the first quarter of 2019, due to the inclusion of revenues generated by Diversigen which was acquired in the fourth quarter of 2019.  

Other revenues in the first quarter of 2020 decreased 55% to $582,000 from $1.3 million in the first quarter of 2019 largely as a result of lower royalty income under a litigation settlement agreement.

CONSOLIDATED OPERATING RESULTS

Consolidated gross profit percentage was 51% for the first quarter of 2020 compared to 60% for the first quarter of 2019. The decrease in gross profit percentage in the first quarter of 2020 was primarily due to a less favorable product mix as a result of higher sales of lower gross profit products and services, increased international freight costs, increased scrap and spoilage expense, and the decline in other revenues which contribute 100% to our gross profit percentage.

Consolidated operating loss for the first quarter of 2020 was $8.0 million, a $4.2 million increased loss from the $3.8 million of operating loss reported in the first quarter of 2019. Results in the first quarter of 2020 were negatively impacted by the lower gross profit percentage, higher legal fees, increased research and development expenses, and the incremental operating expenses added by the Diversigen acquisition which did not occur until the fourth quarter of 2019.

-24-


OPERATING LOSS BY SEGMENT

We evaluate performance of our operating segments based on revenue and operating income. Reportable segments have no inter-segment revenue and inter-segment expenses are eliminated in consolidation, including the fees associated with an intercompany service agreement between OSUR and DNAG.  

OSUR Segment

OSUR’s gross profit percentage was 43% in the first quarter of 2020 compared to 54% in the first quarter of 2019. This decrease is due to a less favorable product mix associated with the increased international HIV product sales and the absence of cryosurgical systems revenues due to the sale of our cryosurgical systems business in August 2019 which generated higher margins.  Gross profit percentage was also negatively impacted by increased international freight costs and higher scrap and spoilage expense.

Research and development expenses increased 28% to $3.5 million in the first quarter of 2020 from $2.7 million in the first quarter of 2019 largely due to increased staffing costs. Sales and marketing expenses of $4.6 million in the first quarter of 2020 were flat compared to the first quarter of 2019. General and administrative expenses increased 20% to $7.3 million in the first quarter of 2020 compared to $6.0 million in the first quarter of 2019 largely due to higher legal fees.

All of the above contributed to OSUR’s first quarter 2020 operating loss of $7.6 million, which included non-cash charges of $861,000 for depreciation and amortization and $1.1 million for stock-based compensation.

DNAG Segment

DNAG’s gross profit percentage was 61% in the first quarter of 2020 compared to 69% in the first quarter of 2019. This decrease is attributable to the decline in other revenues which contribute 100% to the gross profit percentage and a less favorable product mix as a result of higher sales of lower gross profit products and services.

Research and development expenses increased 31% to $2.2 million in the first quarter of 2020 from $1.7 million in the first quarter of 2019 due to higher staffing costs, higher lab supply and consulting costs in support of bioinformatics and new product initiatives, and the inclusion of research and development expense incurred by Diversigen. Sales and marketing expenses increased 2% to $2.8 million in the first quarter of 2020 from $2.7 million in the first quarter of 2019 largely due to expenses incurred by Diversigen not included in the first quarter of 2019, partially offset by a decrease in our reserve for uncollectible accounts. General and administrative expenses largely remained consistent at $2.9 million in both the first quarter of 2020 and 2019.

All of the above contributed to DNAG’s first quarter 2020 operating loss of $405,000, which included a non-cash charge of $1.1 million for the change in the fair value of acquisition-related contingent consideration, $1.3 million for depreciation and amortization, and $300,000 for stock-based compensation.

CONSOLIDATED INCOME TAXES

We continue to believe the full valuation allowance established in 2008 against OSUR’s total U.S. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. For the three months ended March 31, 2020, $9,000 of state income tax expense was recorded compared to $21,000 for the three months ended March 31, 2019. For the three months ended March 31, 2020, foreign tax expense of $703,000 was recorded compared to a foreign tax benefit of $50,000 recorded for the three months ended March 31, 2019.

Liquidity and Capital Resources

 

 

March 31,

 

 

December 31,

 

 

 

2020

 

 

2019

 

 

 

(In thousands)

 

Cash and cash equivalents

 

$

83,365

 

 

$

75,715

 

Available for sale securities

 

 

92,805

 

 

 

114,043

 

Working capital

 

 

197,106

 

 

 

191,837

 

 

Our cash and cash equivalents and available-for-sale securities decreased to $176.4 million at March 31, 2020 from $189.8 million at December 31, 2019. Our working capital increased to $197.3 million at March 31, 2020 from $191.8 million at December 31, 2019.

During the first three months of 2020, we generated $2.5 million in cash from operating activities. Our net loss of $7.3 million included non-cash charges for depreciation and amortization expense of $2.2 million, stock-based compensation expense of $1.4 million, and a charge for the change in the estimated fair value of acquisition-related contingent consideration of $1.1 million and other non-cash benefits of $249,000. Cash used in operating activities also includes a $496,000 contingent consideration payment which represents the excess of the total contingent

-25-


consideration payment made during the first quarter of 2020 over the fair value of the liability estimated at the time of acquisition. Sources of cash generated from our working capital accounts include an $8.6 million decrease in accounts receivable as a result of the collection of large outstanding balances, a $1.0 million decrease in prepaid expenses and other assets associated with lower tax payment made to the Canadian taxing authority, and a $780,000 increase in deferred revenue largely associated with a customer prepayment received for laboratory services. Offsetting these sources of cash were a decrease in accounts payable of $3.1 million due to the payment of vendor invoices that were outstanding at the end of 2019 and a decrease in accrued expenses and other liabilities of $1.7 million largely due to payment of our 2019 management incentive bonuses.

Net cash provided by investing activities was $14.1 million for the three months ended March 31, 2020, which reflects $55.8 million in proceeds from the maturities and redemptions of investments partially offset by $36.9 million used to purchase investments, $2.6 million used to acquire property and equipment, and $2.3 million used to purchase patent and product rights.

Net cash used in financing activities was $4.6 million for the three months ended March 31, 2020, which largely resulted from $3.0 million used for payment of our contingent consideration obligation and $1.4 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted shares awarded to our employees.

We expect current balances of cash and cash equivalents and available-for-sale securities to be sufficient to fund our current and foreseeable operating and capital needs. Our cash requirements, however, may vary materially from those now planned due to many factors, including, but not limited to, the scope and timing of future strategic acquisitions, the progress of our research and development programs, the scope and results of clinical testing, the cost of any future litigation, the magnitude of capital expenditures, changes in existing and potential relationships with business partners, the timing and cost of obtaining regulatory approvals, the timing and cost of future stock purchases, the costs involved in obtaining and enforcing patents, proprietary rights and any necessary licenses, the cost and timing of expansion of sales and marketing activities, market acceptance of new products, competing technological and market developments, the impact of the current economic environment and other factors. In addition, $69.2 million or 39% of our $176.4 million in cash, cash equivalents and available-for-sale securities belongs to our Canadian subsidiary. Repatriation of such cash into the United States exceeding certain levels could have adverse tax consequences.

Summary of Contractual Obligations

A summary of our obligations to make future payments under contracts existing at December 31, 2019 is included in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2019. As of March 31, 2020, there were no significant changes to this information.

Critical Accounting Policies and Estimates

This Management’s Discussion and Analysis of Financial Condition and Results of Operations discusses our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires that we make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, we evaluate our judgments and estimates, including those related to the bad debts, customer sales returns, inventories, intangible assets, income taxes, revenue recognition, performance-based compensation, contingencies and litigation. We base our judgments and estimates on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

A more detailed review of our critical accounting policies is contained in our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC. During the first three months of 2020, there were no material changes to our critical accounting policies.

Item 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We do not hold any amounts of derivative financial instruments or derivative commodity instruments and, accordingly, we have no material derivative risk to report under this Item.

As of March 31, 2020, we did not have any foreign currency exchange contracts or purchase currency options to hedge local currency cash flows. Sales denominated in foreign currencies comprised 5.4% of our total revenues for the three months ended March 31, 2020. We do have foreign currency exchange risk related to our operating subsidiaries in Canada and in Belgium. The principal foreign currencies in which we conduct business are the Canadian dollar and the Euro. Fluctuations in the exchange rate between the U.S. dollar and these foreign currencies could affect year-to-year comparability of operating results and cash flows. Our foreign subsidiaries had net assets, subject to translation, of $111.1 million in U.S. Dollars, which are included in the Company’s consolidated balance sheet as of March 31, 2020. A 10% unfavorable change in the Canadian-to-U.S. dollar and Euro-to-U.S. dollar exchange rates would have decreased our comprehensive income by approximately $9.0 million in the three months ended March 31, 2020.

-26-


Item 4.

CONTROLS AND PROCEDURES

(a) Evaluation of Disclosure Controls and Procedures. The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934) as of March 31, 2020. Based on that evaluation, the Company’s management, including such officers, concluded that the Company’s disclosure controls and procedures were effective as of March 31, 2020 to provide reasonable assurance that material information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934 was accumulated and communicated to the Company’s management, including the Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure and was recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission.

(b) Changes in Internal Control Over Financial Reporting. There was no change in the Company’s internal control over financial reporting that occurred during the three months ended March 31, 2020 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

-27-


 

PART II. OTHER INFORMATION

Item 1.

From time to time, we are involved in certain legal actions arising in the ordinary course of business. In management’s opinion, based upon the advice of counsel, the outcomes of such actions are not expected, individually or in the aggregate, to have a material adverse effect on our future financial position or results of operations.

 

On February 6, 2017, DNA Genotek, Inc. (“DNAG”) entered into a settlement and license agreement (the “Settlement Agreement”) in order to settle certain patent infringement and breach of contract litigation against Ancestry.comDNA, LLC (“Ancestry”) and its contract manufacturer.  This litigation was related to a saliva DNA collection device sold by Ancestry that was similar to products sold by DNAG.  Under the terms of the Settlement Agreement, DNAG and Ancestry agreed to certain procedures for considering whether future versions of Ancestry’s saliva DNA collection product are covered by the DNAG patents licensed to Ancestry (the “Licensed Patents”) and thus subject to ongoing royalties under  the Settlement Agreement.  We have been in a dispute with Ancestry regarding whether yet-to-be launched Ancestry products are covered by the Licensed Patents.  In March 2019, Ancestry filed a Dispute Notice and Request for Arbitration (the “Notice”) with an alternative dispute resolution services provider in order to initiate a binding arbitration proceeding pursuant to the Settlement Agreement.  DNAG denied the allegations contained in the Notice and asserted that the potential new Ancestry products are covered by the Licensed Patents and would be subject to ongoing royalties if such products are commercialized by Ancestry.  A panel of arbitrators was appointed (the “Panel”) and this arbitration proceeding was completed in early 2020.  In February 2020, the Panel issued a decision that found that the potential new Ancestry products do not infringe the DNAG patents asserted in the arbitration.  As a result, these new Ancestry products will not be subject to the royalties under the Settlement Agreement.  Under the terms of the Settlement Agreement, the Panel’s decision is final and binding on the parties.

 

Item 1A.

RISK FACTORS

 

The risk factors set forth in this report update, and should be read together with, the risk factors discussed in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019.

Economic Volatility and Disruption Could Adversely Affect Our Results of Operations, Cash Flow and Financial Condition or Those of Our Customers and Suppliers.

Global and U.S. markets and economies have experienced extreme volatility and disruption following the global outbreak of COVID-19 that began in December 2019. Many economists and major investment banks have expressed concern that the continued spread of the virus globally has led or will lead to a world-wide economic downturn. Volatile economic conditions may occur again or continue in the future. These conditions could adversely affect our financial performance and condition or those of our customers and suppliers. These circumstances could also adversely affect our access to liquidity needed to conduct or expand our business or conduct future acquisitions or make other discretionary investments. Many of our customers rely on public funding provided by federal, state and local governments, and this funding has been and may continue to be reduced or deferred as a result of economic conditions or other factors. These circumstances may adversely impact our customers and suppliers, which, in turn, could adversely affect their ability to purchase and/or distribute our products or supply us with necessary equipment, raw materials or components. Even with the improvement of economic conditions, it may take time for our customers and suppliers to establish new budgets and return to normal purchasing and shipping patterns. We cannot predict the reoccurrence of any economic slowdown or the strength or sustainability of an economic recovery.

Terrorist Attacks, Natural Disasters, Public Health Crises or Other Catastrophic Events Outside of Our Control May Adversely Affect Our Business.

Terrorist attacks, natural disasters, public health crises or other catastrophic events outside of our control, including pandemics, and subsequent governmental responses to these events, could cause economic instability. These actions could adversely affect economic conditions both within and outside the United States and reduce demand for our products.  For example, the COVID-19 outbreak has led to, and for an unknown period of time will continue to lead to, disruptions in local, regional, national and global markets and economies affected thereby, including the United States.  This outbreak has resulted in, and until fully resolved is likely to continue to result in, among other things: (i) restrictions on travel, government mandated social distancing measures, and the temporary closure of many corporate offices, retail stores, and manufacturing facilities and factories; (ii) significant disruption to the business of many companies, including our customers and suppliers, as well as layoffs of employees; (iii) reduction or termination by public health and other customers of infectious disease testing programs, including for HIV and HCV, and a reallocation of personnel and monetary resources from these programs to programs intended to address COVID-19; (iv) reduction or termination of clinical and research studies by academic and other entities that use our molecular collection products and laboratory services; and (v) rapidly evolving proposals and actions by state and federal governments to address the problems being experienced by markets, businesses and the economy in general, which may have unintended consequences or may not adequately address such problems.  These events have disrupted, and threaten to continue to disrupt, our normal operation, the operations of our customers and suppliers and eliminate, reduce or delay

-28-


our customers’ ability to purchase and use our products and our suppliers’ ability to provide raw materials and finished products.  Despite our efforts to manage and mitigate the impact of these events on us, it is impossible to predict the precise nature and consequences of these events, or of any political or policy decisions and regulatory changes occasioned by emerging events or uncertainty under applicable laws or regulations that impact us. It is clear that these types of events are impacting and will, for at least some time, continue to impact our operation and in many instances the impact will be adverse and may be material. Any potential impact to our results of operations will depend to a large extent on future developments and new information that could emerge regarding the duration and severity of the COVID-19 pandemic and the actions taken by authorities and other entities to contain the spread or treat its impact, all of which are beyond our control. These potential impacts, while uncertain, could adversely affect our business and results of operation.

Various types of disasters, including earthquakes, fires, floods, acts of terrorism and pandemics, may also affect our manufacturing facilities and computer systems, and increase our cybersecurity risks. Although we have business interruption insurance, our facilities, including some pieces of manufacturing equipment and our computer systems, may be difficult to replace and could require substantial replacement lead-time. In the event our existing manufacturing facilities or computer systems are affected by man-made or natural disasters, including pandemics, we may have difficulty operating our business and may be unable to manufacture products for sale or meet customer demands or sales projections. If our manufacturing operations were curtailed or shut down entirely, it would seriously harm our business. Moreover, we may incur incremental costs following an unforeseen event which could adversely affect our results of operation.

The Use of Third Party Supply Sources For Critical Components of Our Products Could Adversely Affect Our Business.

We currently purchase certain critical components of our products from sole supply sources or other third-party suppliers. For example, the biological antigens and antibodies, nitrocellulose and certain other components required to make our OraQuick HIV, HCV and Ebola products are currently purchased from sole source suppliers. Our OraSure QuickFlu® test and the fully automated high-throughput drug assays sold with our Intercept i2® device are manufactured and supplied by sole source suppliers and the conjugates used in our MICROPLATE oral fluid drugs-of-abuse assays are obtained from third-party suppliers. We have contracted with a third party in Thailand for the assembly of OraQuick® HIV device and the OraQuick® HIV Self-Test in order to supply certain international markets. In addition, our subsidiary, DNAG, uses two third-party manufacturers to supply virtually all of its products, including its Oragene® line of collection kits. Many of the raw materials and components used in its products are also purchased from third parties, a critical one of which is obtained from a sole source supplier.

The COVID-19 pandemic and the measures taken to contain the spread of the virus, could disrupt the normal operations of our third-party suppliers.  Our third-party suppliers may not have the personnel, raw materials, capacity, or capability to manufacture our products according to our schedule and specifications.  To the extent any such production and distribution interruption or closures occur and continue for an extended period of time, the impact on our supply chain could have a material adverse effect on our results of operations. If our third-party suppliers are unable or unwilling to supply or manufacture a required component or product or if they make changes to a component, product or manufacturing process or do not supply materials meeting our specifications, we may need to find another source and/or manufacturer. This could require that we perform additional development work and it may be difficult to find such an alternate supply source in a reasonable time period or on commercially reasonable terms, if at all. We may also need to obtain FDA or other regulatory approvals for the use of an alternative component or for changes to our products or manufacturing process. Completing that development and obtaining such approvals could require significant time and expense and such approvals may not occur at all. The availability of critical components and products from sole supply sources or other third parties could also reduce our control over pricing, quality and timely delivery. These events could either disrupt our ability to manufacture and sell certain of our products into one or more markets or completely prevent us from doing so, and could increase our costs. Any such event could have a material adverse effect on our results of operations, cash flow and business.

Our Future Success Depends Upon Market Acceptance of Our Existing and Future Products and Service Offerings.

We believe successful new product and service introductions provide a significant competitive advantage because customers make an investment of time in selecting and learning to use a new product or service and are reluctant to switch thereafter. Our future success will depend, in part, on the market acceptance, and the timing of such acceptance, of new products such as our in-home antigen self-test for pan-SARS-coronavirus (“Coronavirus Self-Test”), laboratory-based pan-SARS-coronavirus antibody test (“Coronavirus Antibody Test”), OraQuick® HIV Self-Test , OraQuick® Ebola test and  OMNIgene®  GUT product offerings, and other new products or technologies that may be developed or acquired. In addition, our future revenues will depend on market acceptance of new uses for our saliva collection products, including for COVID-19 testing, and our new service offerings, such as the microbiome laboratory testing and analytical services we provide through CoreBioime and Diversigen.  To achieve market acceptance, we will likely be required to undertake clinical studies to validate the new uses for our products and substantial marketing efforts and spend significant funds to complete product development and clinical studies and inform potential customers and the public of the existence and perceived benefits of these products and services. In addition, governmental funding may be needed to help complete development, obtain required regulatory approvals and create market acceptance and expand the use of these products and services.

There may be limited evidence on which to evaluate the market reaction to products and services that may be developed and our marketing efforts for new products and services or products with new uses may not be successful. The market for microbiome products and services is in its early stages and its future development and acceptance by our customers is uncertain.  It is also possible that governmental funding may be limited for new products, such as our Coronavirus Self-Test and Coronavirus Antibody Test or the new sample collection and stabilization products being commercialized by DNAG. Also, we are still in the process of developing the Coronavirus Self-Test and Coronavirus Antibody Test and validating the use of existing products for COVID-19 testing, and it is uncertain whether we will be successful in our development and validation

-29-


efforts or whether these products will prove effective, receive applicable regulatory approvals and gain widespread acceptance in the marketplace. As such, there can be no assurance that any products or services will obtain significant market acceptance and fill the market need that is perceived to exist on a timely basis, or at all.

 

Item 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Period

 

Total number of shares purchased

 

 

 

Average price paid per Share

 

 

Total number of shares purchased as part of publicly announced plans or programs

 

 

Maximum number (or approximate dollar value) of shares that may yet be repurchased under the plans or programs (1, 2)

 

January 1, 2020 - January 31, 2020

 

 

227

 

(3)

 

$

7.91

 

 

 

 

 

 

11,984,720

 

February 1, 2020 - February 29, 2020

 

 

196,734

 

(3)

 

 

7.15

 

 

 

 

 

 

11,984,720

 

March 1, 2020 - March 31, 2020

 

 

 

 

 

 

 

 

 

 

 

 

11,984,720

 

 

 

 

196,961

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1)

On August 5, 2008, our Board of Directors approved a share repurchase program pursuant to which we are permitted to acquire up to $25.0 million of outstanding shares. This share repurchase program may be discontinued at any time.

(2)

This column represents the amount that remains available under the $25.0 million repurchase plan, as of the period indicated. We have made no commitment to purchase any shares under this plan.

(3)

Pursuant to the OraSure Technologies, Inc. Stock Award Plan, and in connection with the vesting of restricted shares, these shares were retired to satisfy minimum tax withholdings.

Item 3.

DEFAULTS UPON SENIOR SECURITIES

None

Item 4.

MINE SAFETY DISCLOSURES

Not applicable

Item 5.

OTHER INFORMATION

None

-30-


 

Item 6.

EXHIBITS

 

 

 

 

Exhibit

Number

  

Exhibit

 

 

10.1*

 

Description of OraSure Technologies, Inc. 2020 Incentive Plan is incorporated by reference to Item 5.02 to the Company’s Current Report on Form 8-K filed February 21, 2020.

 

 

 

10.2*

 

Description of OraSure Technologies, Inc. Long-Term Incentive Policy and 2019 Award Performance Measures is incorporated by reference to Item 5.02 to the Company’s Current Report on Form 8-K filed February 21, 2020.

 

 

 

10.3*

 

Employment Agreement dated as of May 11, 2020 between OraSure Technologies, Inc. and Lisa A. Nibauer.

 

 

 

  31.1

 

Certification of Stephen S. Tang required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.

 

 

  31.2

 

Certification of Roberto Cuca required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.

 

 

  32.1

 

Certification of Stephen S. Tang required by Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

  32.2

 

Certification of Roberto Cuca required by Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

101.INS

 

Inline XBRL Instance Document – the Instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Labels Linkbase Document

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

Exhibit 104

 

Cover Page from the Company’s Quarterly Report on Form 10-Q for the Quarter Ended March 31, 2020 has been formatted in Inline XBRL

 

* Management contract or compensation plan arrangement.

Filed herewith

-31-


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

ORASURE TECHNOLOGIES, INC.

 

 

 

 

 

 

 

/s/ Roberto Cuca

Date: May 11, 2020

 

 

Roberto Cuca

 

 

 

Chief Financial Officer

 

 

 

(Principal Financial Officer)

 

 

 

 

 

 

 

/s/Michele M. Miller

Date: May 11, 2020

 

 

Michele M. Miller

 

 

 

Vice President, Finance and Controller

 

 

 

(Principal Accounting Officer)

 

 

-32-

OraSure Technologies (NASDAQ:OSUR)
Historical Stock Chart
From Jun 2024 to Jul 2024 Click Here for more OraSure Technologies Charts.
OraSure Technologies (NASDAQ:OSUR)
Historical Stock Chart
From Jul 2023 to Jul 2024 Click Here for more OraSure Technologies Charts.