Irgendwie taucht die Firma nirgendswo auf...
On Monday, shares of the Irish biotechnology outfit Trinity Biotech (TRIB) surged 57% to $5.14, nearly a four-year high, after U.S. regulators approved Trinity's 10-minute test for detecting HIV. The stock of OraSure Technologies (OSUR), which makes a rival HIV test, fell 5% to $8.25.
"The HIV rapid test could jump Trinity's growth curve very dramatically," says Elemer Piros, an analyst at Rodman & Renshaw, a New York investment bank, "because of the attractive margin that it could experience in the U.S."
The Food and Drug Administration's blessing makes Trinity's Uni-Gold Recombigen HIV the first product approved for testing blood serum, plasma or whole blood to detect antibodies to the virus that causes AIDS. Trinity said the trial data it submitted to the FDA showed that its test detected 100% of the HIV positive specimens and was 99.7% accurate on the negative samples for about 9,000 patients. OraSure's OraQuick Rapid HIV-1 test, approved in November 2002, takes 20 minutes but can only be used on whole blood. Both tests are a step up from conventional laboratory tests, which often take hours or days to give a result.
Trinity, which plans to market the test to government programs and physicians, expects hospitals to be its main market. The company says the test could provide immediate help to medical professionals who are stuck with potentially contaminated needles about 800,000 times a year and require an immediate HIV test. In addition, about 200,000 pregnant women at risk for HIV are tested in hospitals each year.
Currently, Trinity's test is sold in Africa and Asia and approved for the World Health Organization's HIV testing program in Africa. The company sells about four million tests in Africa and expects to sell between 400,000 and 500,000 tests in the U.S. next year. Trinity says the conversion of lab-based HIV tests to rapid tests represents an annual market opportunity of $30 million.
For the third quarter, the company, which makes more than 500 diagnostic products for detecting a variety of diseases and disorders, posted a profit of $1.8 million, or four cents a share, on revenue of $16.9 million.
Rodman & Renshaw's Piros predicts Trinity will earn 14 cents a share for 2003. Next year, he projects the HIV test will bring in sales of $5 million, rising to $8 million in 2005 and $11.5 million in 2006. While that $11.5 million would only be 13% of total revenue, Piros predicts it will be 20% of gross margins, bringing annual profits to 23 cents a share.
Prior to Monday's announcement, the consensus estimate among analysts polled by Thomson First Call was for Trinity to earn 17 cents a share for 2003 and 19 cents for 2004.
"Trinity's revenue growth rate has been about 25% per annum; we've been a very acquisitive company," says Trinity President Brendan Farrell. "Earnings growth has not matched as fast, since we have invested a lot in a direct sales force in Germany and the U.S. But earnings should match revenue growth going forward."
Farrell says the HIV test currently accounts for 7% of the 12-year-old company's revenue, which he estimates to be about $67 million this year. Gross margins are currently 45%. He expects the test to sell for between $10 and $13, and bring in gross margins "north of 80%." By the end of 2004, 15% of the company's sales will come from the HIV test, with about half from the U.S.
According to Piros, the wildcard in the equation is the adoption by physicians outside of hospitals, which he hasn't included in his calculations. That's because family doctors may avoid the rapid HIV test since they'd need to offer immediate counseling to those testing positive.
But problems over at OraSure may give Trinity an opportunity to corner more of the market quickly. Even though OraSure's test has been available for a year, three months ago the company terminated its marketing relationship with Abbott Laboratories (ABT), its sole distributor. OraSure cited Abbott's failure to meet its obligation of minimum monthly purchases.
"Orasure had a 12-month lead," says Piros, "but it was equalized by the fact Abbott didn't carry the day. Now, it needs to do the same process as Trinity does with building a sales force. Plus, the OraSure version test isn't as user friendly in the hospital environment as the Trinity product."
Quote: "The playing field is level right now," says Rodman & Renshaw's Piros, "the only difference being Trinity has a better quality test. OraSure is currently valued at $340 million and Trinity is valued at half that much. The key difference is perception because OraSure was the market leader. But according to our thesis, this difference could be cut and the situation could completely reverse during the next six to 12 moths after Trinity establishes that its test is more favorable and will be adopted." (Piros doesn't own shares of Trinity Biotech; Rodman & Renshaw has an investment-banking relationship with the company.)
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