OraSure Technologies, Inc. Announces Full-Year and Fourth Quarter 2014 Financial Results

BETHLEHEM, Pa., Feb. 4, 2015 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in oral fluid diagnostics, today announced its consolidated financial results for the full-year and fourth quarter ended December 31, 2014.

Financial Highlights

  • The Company exceeded $100 million in annual revenues for the first time in its history. Consolidated net revenues for the year ended December 31, 2014 were $106.5 million, an 8% increase from the comparable period of 2013.
  • Consolidated net revenues for the fourth quarter of 2014 were $28.7 million, which approximated the level of revenues reported in the fourth quarter of 2013.
  • Licensing and product development revenues were $3.4 million and $7.6 million for the quarter and year ended December 31, 2014, respectively, and represent the recognition of payments under the Company’s’ HCV collaboration with AbbVie.
  • Net revenues generated by the Company’s molecular collection systems subsidiary, DNA Genotek (“DNAG”), were $6.3 million and $23.8 million for the fourth quarter and full-year of 2014, respectively, representing an 8% decrease and a 17% increase over the fourth quarter and full-year of 2013, respectively. DNAG accounted for 22% of the Company’s aggregate 2014 consolidated net revenues.
  • Net revenues for the Company’s OraQuick® rapid HCV test were $1.7 million and $7.3 million for the fourth quarter and full-year of 2014, respectively, representing a 10% decrease and a 42% increase over the fourth quarter and full-year of 2013, respectively.
  • Consolidated net loss for the fourth quarter of 2014 was $2.7 million, or $0.05 per share, which compares to net income of $6.2 million, or $0.11 per share, for the fourth quarter of 2013. This change in the current quarter bottom line performance was primarily the result of the absence of an $8.3 million contract termination payment received in the prior year period. Consolidated net loss for the year ended December 31, 2014 was $4.6 million, or $0.08 per share, which compares to a net loss of $11.2 million, or $0.20 per share, for the comparable period of 2013.
  • Cash and short term investments totaled $97.9 million and working capital amounted to $104.8 million at December 31, 2014.

“Crossing the $100 million threshold in annual revenues has been a long-term goal and is a significant milestone for our Company,” said Douglas A. Michels, President and CEO of OraSure Technologies. “The molecular collection systems segment continues to deliver strong results and our HCV business continues to grow. Our immediate focus is on increasing usage of our OraQuick® HCV test under our HCV collaboration with AbbVie, continuing the strong performance at DNA Genotek, and pursuing a potential rapid Ebola test, including securing development funding and purchase commitments for this proposed new product.”

Financial Results

Consolidated net product revenues for the fourth quarter of 2014 decreased 12% from the comparable period of 2013, primarily as a result of the change in revenue recognition policy related to the Company’s OraQuick® In-Home HIV test which increased fourth quarter 2013 net revenues by $2.5 million. Consolidated net product revenues for the year ended December 31, 2014 increased 1% over the prior year period, primarily as a result of higher sales of the Company’s molecular collection systems, OraQuick® HCV and cryosurgical systems products. These increases were partially offset by lower sales of the OraQuick® professional HIV product line and OraQuick® In-Home HIV test. OraQuick® HIV In-Home revenues in 2013 included the $2.5 million non-recurring favorable adjustment resulting from the accounting policy change.

Consolidated licensing and product development revenues for the fourth quarter and full-year of 2014 were $3.4 million and $7.6 million, respectively. Consolidated licensing and product development revenues for the fourth quarter and full-year of 2013 were $0 and $623,000, respectively. Licensing and product development revenues in 2014 represent the recognition of exclusivity payments under the Company’s HCV collaboration agreement with AbbVie. Licensing and product development revenues in 2013 represent royalties paid on domestic outsales of a licensee’s OTC cryosurgical wart removal product, pursuant to a license agreement that expired in that same year.

Consolidated gross margin for both the three months and year ended December 31, 2014 was 63%. Consolidated gross margin for the three months and year ended December 31, 2013 was 60% and 59%, respectively. Gross margin for the current quarter improved largely as a result of the increased licensing and product development revenues and a more favorable product mix resulting from higher margin DNAG sales, partially offset by a decline in overhead absorption as a result of facility equipment replacements. Gross margin for the full-year 2014 also improved largely due to the increased licensing and product development revenues and higher margin DNAG sales.

Consolidated operating expenses increased to $20.5 million during the fourth quarter of 2014 compared to $11.1 million in the comparable period of 2013. This increase was primarily due to the absence of an $8.3 million contract termination payment from Roche Diagnostics which was received in the fourth quarter of 2013. This payment, coupled with lower promotional expenses associated with the Company’s OraQuick® In-Home HIV test, were partially offset by increased expenses incurred under the HCV collaboration with AbbVie , higher research and development costs and higher staffing expenses. Promotional expenses for the OraQuick® In-Home HIV test were $614,000 and $4.6 million for the fourth quarters of 2014 and 2013, respectively.

For the year ended December 31, 2014, consolidated operating expenses increased to $71.4 million from the $70.8 million reported for the prior year. This increase was primarily due to a $2.8 million reduction in contract termination payments received from Roche Diagnostics during 2014, increased expenses incurred under the HCV collaboration with AbbVie, higher research and development costs, and higher legal, staffing and consulting costs, partially offset by lower promotional expenses associated with the Company’s OraQuick® In-Home HIV test. Full-year promotional expenses for the OraQuick® In-Home HIV test were $8.5 million and $18.8 million for 2014 and 2013, respectively.

For the three months and year ended December 31, 2014, the Company recorded Canadian income tax expense of $376,000 and $343,000, respectively. For the three months and year ended December 31, 2013, the Company recorded Canadian income tax expense of $14,000 and a Canadian income tax benefit of $772,000 respectively. The 2013 full-year tax benefit was the result of certain Canadian research and development and investment tax credits and DNAG’s loss before income taxes in that period.

The Company’s cash and short-term investment balance totaled $97.9 million at December 31, 2014 compared to $93.2 million in cash at December 31, 2013. Working capital was $104.8 million at December 31, 2014 compared to $100.6 million at December 31, 2013. For the year ended December 31, 2014, the Company’s consolidated operations generated $7.5 million of cash.

First Quarter 2015 Outlook

The Company expects consolidated net revenues to range from $26.5 to $27.0 million and is projecting a consolidated net loss of approximately $0.01 to $0.02 per share for the first quarter of 2015.

Financial Data

Condensed Consolidated Financial Data
(In thousands, except per-share data)
Unaudited
Three months ended Year ended
December 31, December 31,
2014 2013 2014 2013
Results of Operations
Net revenues1 $ 28,681 $ 28,768 $ 106,464 $ 98,940
Cost of products sold 10,704 11,640 39,840 40,351
Gross profit 17,977 17,128 66,624 58,589
Operating expenses:
Research and development 3,817 2,212 12,058 10,932
Sales and marketing 10,290 11,241 41,118 46,465
General and administrative 6,433 5,912 23,750 21,654
Gain on contract termination settlement -- (8,300) (5,500) (8,300)
Total operating expenses 20,540 11,065 71,426 70,751
Operating income (loss) (2,563) 6,063 (4,802) (12,162)
Other income (expense) 287 164 531 200
Income (loss) before income taxes (2,276) 6,227 (4,271) (11,962)
Income tax expense (benefit) 376 14 343 (772)
Net income (loss) $ (2,652) $ 6,213 $ (4,614) $ (11,190)
Earnings (loss) per share:
Basic and Diluted $ (0.05) $ 0.11 $ (0.08) $ (0.20)
Weighted average shares:
Basic 56,105 55,616 55,949 55,555
Diluted 56,105 56,176 55,949 55,555
_________________
1Net revenues for the three months and year ended December 31, 2013 include a non-recurring net favorable $2.5 million adjustment to reflect a change in the Company’s revenue recognition policy related to its OraQuick® In-Home HIV test.

Summary of Net Revenues by Market and Product (Unaudited)

Three Months Ended December 31,
Percentage of
Total Net
Dollars Revenues
%
Market 2014 2013 Change 2014 2013
Infectious disease testing $ 12,602 $ 15,436 (18)% 44% 54%
Substance abuse testing 2,250 2,116 6 8 7
Cryosurgical systems 3,377 3,558 (5) 11 12
Molecular collection systems 6,255 6,831 (8) 22 24
Insurance risk assessment 800 827 (3) 3 3
Net product revenues 25,284 28,768 (12) 88 100
Licensing and product development 3,397 -- NM* 12 --
Net revenues $ 28,681 $ 28,768 (0)% 100% 100%
Year Ended December 31,
Percentage of
Total Net
Dollars Revenues
%
Market 2014 2013 Change 2014 2013
Infectious disease testing $ 47,515 $ 50,961 (7)% 45% 51%
Substance abuse testing 8,437 8,571 (2) 8 9
Cryosurgical systems 15,505 14,468 7 15 14
Molecular collection systems 23,778 20,381 17 22 21
Insurance risk assessment 3,659 3,936 (7) 3 4
Net product revenues 98,894 98,317 1 93 99
Licensing and product development 7,570 623 NM* 7 1
Net revenues $ 106,464 $ 98,940 8% 100% 100%
* Calculation is not considered meaningful
Three Months Ended Year Ended
December 31, December 31,
% %
OraQuick® Revenues 2014 2013 Change 2014 2013 Change
Domestic HIV $ 8,363 $ 8,447 (1)% $ 29,933 $ 32,301 (7)%
International HIV 587 907 (35) 2,483 3,365 (26)
Domestic HIV OTC1 1,502 3,909 (62) 6,493 9,106 (29)
Net HIV revenues 10,452 13,263 (21) 38,909 44,772 (13)
Domestic HCV 1,036 1,073 (3) 4,220 2,847 48
International HCV 707 860 (18) 3,048 2,268 34
Net HCV revenues 1,743 1,933 (10) 7,268 5,115 42
Net OraQuick® revenues $ 12,195 $ 15,196 (20)% $ 46,177 $ 49,887 (7)%
Three Months Ended Year Ended
December 31, December 31,
% %
Intercept® Revenues 2014 2013 Change 2014 2013 Change
Domestic $ 1,629 $ 1,453 12% $ 6,101 $ 5,693 7%
International 73 115 (37) 149 500 (70)
Net Intercept® revenues $ 1,702 $ 1,568 9% $ 6,250 $ 6,193 1%
Three Months Ended Year Ended
December 31, December 31,
% %
Cryosurgical Systems Revenues 2014 2013 Change 2014 2013 Change
Domestic professional $ 2,149 $ 1,828 18% $ 6,750 $ 6,020 12%
International professional 111 402 (72) 693 1,441 (52)
Domestic over-the-counter 108 -- 100 108 -- 100
International over-the-counter 1,009 1,328 (24) 7,954 7,007 14
Net cryosurgical systems revenues $ 3,377 $ 3,558 (5)% $ 15,505 $ 14,468 7%
_________________
1Net revenues for the three months and year ended December 31, 2013 include a non-recurring net favorable $2.5 million adjustment to reflect a change in the Company’s revenue recognition policy re
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