ORASURE TECHNOLOGIES INC quarterly report, Q1 FY2017

OraSure Technologies, Inc. — Q1 2017 Form 10-Q

Reporting period: Three months ended March 31, 2017; unaudited. Comparisons are with Q1 2016 unless otherwise noted. OraSure develops and sells diagnostic products and specimen-collection devices through its OSUR and DNAG (molecular collection systems) businesses.

Financial performance

MetricQ1 2017Q1 2016Change
Net revenue$32.5 million$29.1 million+12%
Product revenue$31.5 million$25.2 million+25%
Gross profit / margin$20.3 million / 62%$20.3 million / 70%Margin down 8 points
Operating income$15.9 million$2.7 millionIncludes $12.5 million litigation-settlement gain
Net income$12.4 million$2.4 millionEPS: $0.21 diluted vs. $0.04
Operating cash flow$12.6 million$4.7 million2017 includes settlement proceeds

Revenue growth was driven by molecular-product sales and higher international HIV and HCV test sales. Other revenue fell to $1.1 million from $3.8 million, primarily because the AbbVie HCV co-promotion agreement ended in December 2016; Q1 2016 included $3.4 million of exclusivity revenue. Gross margin declined amid the absence of that revenue, increased scrap and spoilage, and a higher mix of lower-margin sales. The $12.5 million Ancestry settlement was recorded as a reduction of operating expenses; excluding that gain, reported operating income would have been approximately $3.4 million.

Segments and material changes

  • OSUR: Revenue was $21.8 million, down 2% overall; product revenue rose 13% to $20.8 million. Infectious-disease testing revenue increased 28%, led by international HIV and HCV sales. Domestic professional HIV sales fell 33%, cryosurgical revenue fell 21%, and OSUR reported an operating loss of $0.2 million.
  • DNAG: Revenue increased 55% to $10.7 million, reflecting stronger commercial Oragene sales and microbiome-product revenue. Academic-market sales declined. Segment operating income was $16.1 million, substantially reflecting the settlement gain.
  • International customers generated $11.7 million, or 36% of revenue, versus $6.9 million, or 24%, a year earlier. International HIV and HCV orders can be sporadic and dependent on government funding and other factors.

Cash, liquidity and debt

  • At March 31, cash and cash equivalents were $120.9 million, restricted cash was $1.8 million, and short-term investments were $18.8 million; combined cash, restricted cash and investments totaled about $141.5 million. Working capital was $162.3 million.
  • Operating activities provided $12.6 million; investing activities used $8.4 million, including $7.5 million for short-term investments and $0.9 million for property and equipment. Financing activities provided $8.6 million, including $9.4 million from option exercises, partly offset by $0.9 million for shares withheld for taxes.
  • No borrowings were outstanding under the $10 million revolving credit facility. The company could request up to $5 million of additional commitments at the lender’s discretion; the facility matures September 2019. OraSure reported covenant compliance and expected available cash and borrowing capacity to fund needs for the foreseeable future.

Outlook, risks and unusual items

  • No quantified revenue or earnings guidance is provided. Management says liquidity is expected to cover current operating and capital needs for the foreseeable future, while noting that cash requirements may vary.
  • OraSure reported a contract to supply more than $20 million of DNA saliva-collection kits to a genomics customer over a period exceeding 12 months; timing and fulfillment remain relevant to monitor.
  • The Ancestry/Spectrum litigation was settled effective February 6, 2017. OraSure received $12.5 million and granted Ancestry a limited royalty-bearing license; the agreement also provides OraSure a royalty-free license to certain Ancestry patents. Related lawsuits and patent-review proceedings were dismissed or terminated.
  • Key risks include reliance on government funding and uneven international orders, competition and changing testing guidelines, sole-source suppliers, regulatory and product-development execution, patent matters, and foreign-exchange exposure. The company reported no material change to its previously disclosed risk factors.
  • A 10% unfavorable Canadian-dollar exchange-rate movement would have reduced Q1 comprehensive income by $5.9 million, according to the filing. One customer represented 22% of accounts receivable at quarter-end.

Important facts for investors to verify

  • Whether DNAG’s greater-than-$20 million supply contract converts into shipments and revenue on the expected schedule.
  • Whether strong international HIV/HCV and molecular-product sales persist, given ordering variability and funding dependence.
  • Underlying profitability and margins excluding the one-time $12.5 million settlement gain, and the drivers of lower gross margin.
  • Collection timing for international receivables and the concentration of receivables with a major customer.
  • Settlement-license royalty terms, future patent-related developments, and exposure to Canadian-dollar movements and sole-source suppliers.