NEW YORK (GenomeWeb News) — Cepheid said after the close of the market Thursday that its first quarter revenues grew 16 percent year over year driven by 26 percent growth in its clinical business.
In addition, the company disclosed during a conference call following the earnings release that it received Chinese Food and Drug Administration clearance for its Xpert MTB/RIF test.
The Sunnyvale, Calif.-based molecular diagnostics firm reported total first quarter revenues of $106.9 million for the quarter ended March 31, up from $91.9 million in the comparable quarter a year ago, and beating average analyst estimates of $104.9 million.
Clinical systems revenue grew 38 percent to $17.3 million from $12.5 million, while clinical reagents revenue spiked 24 percent to $83.1 million from $67.1 million. Meantime, non-clinical and other revenue shrunk nearly in half to $6.5 million from $12.3 million.
Cepheid placed a total of 503 GeneXpert systems in the quarter — 181 systems in its commercial clinical business, including seven high-throughput Infinity systems, and 322 systems as part of its high-burden developing country (HBDC) program. The company said it has now placed a cumulative total of 6,012 GeneXpert systems worldwide.
"As expected, commercial clinical systems were down in the first quarter after our record-breaking Q4," Cepheid CEO John Bishop said during the conference call. "Nevertheless, commercial clinical system revenue of $11.2 million was very strong and in fact set a new record for the strongest first-quarter performance in the company's history."
Of note, HBDC revenues were up 69 percent in Q1, growing more than $7 million to $18.3 million, Bishop said. During Q1, 322 HBDC system placements included 160 in Brazil to support the initial phases of a planned national rollout.
In addition, Bishop disclosed that late in Q1 Cepheid received Chinese FDA clearance for Xpert MTB/RIF.
"With the clearance behind us we expect to ship more than 700 GeneXpert systems supported by the [Global Fund to Fight AIDS, Tuberculosis, and Malaria] to be shipped to China in the second quarter," Bishop said. "Combined with the 179 systems already placed in China, this will bring the HBDC installed base in that country to almost 900. To put that in perspective, the HBDC installed base in South Africa at the end of the first quarter was 342."
Cepheid also recently commercialized its Xpert HPV and Xpert Norovirus assays to bring its total Xpert assay tally to 14 tests. Growing adoption of the company's broad menu of tests helped drive commercial clinical Xpert reagent growth of 20 percent in Q1, the company noted in a statement.
"GeneXpert system placements are increasingly driven by broad menu adoption, so while we continue to add new HAI customers and test volumes continue to grow, we more often see our HAI tests placed with one or more non-HAI assays," Bishop said.
Cepheid reported a net loss for the quarter of $9.3 million, or $.13 per share, compared to net income of $313,000, or break-even on an EPS basis, in Q1 2013. On a non-GAAP basis, its Q1 net loss was $600,000, or $.01 per share. On average, analysts had estimated a net loss of $.17 per share.
The company's R&D expenses totaled $21.7 million, up about 23 percent from $17.7 million in the year-ago period, while SG&A expenses rose 28 percent to $37.1 million from $28.9 million.
Cepheid ended the quarter with $136.7 million in cash and cash equivalents, and $131 million in short-term investments.
The firm updated its full-year 2014 guidance to total revenue in the range of $446 million to $461 million and a net loss in a range from $.43 to $.38 per share. In its Q4 and full-year 2013 earnings release in January the company had guided to a similar revenue range, but said it expected a range of $.26 to $.21 for its net loss per share.