SAN FRANCISCO (GenomeWeb News) – The 31st Annual JP Morgan Healthcare Conference kicked off here yesterday with several life science tools and diagnostic firms making presentations to investors and other attendees.
The following are capsules from the presentations and breakout sessions of Myriad Genetics, Bruker, Genomic Health, Qiagen, and Waters.
Myriad CEO Peter Meldrum talked about the variety of products Myriad is developing to diversify its product offerings beyond its well-known BRACAnalysis tests and into new markets beyond oncology and women's health. The firm is hoping its Prolaris test for aiding treatment decisions for men with prostate cancer will provide a significant revenue boost. Meldrum noted that the firm is currently seeking reimbursement from Medicare for the test, but that process could take between 18 months and two years. Prolaris currently lists for $3,400, and Myriad said that it addresses a $2 billion market opportunity. The company has 20 sales reps detailing Prolaris, and it recently presented data from nine studies that included 3,000 patients to support claims about the test's efficacy.
But Myriad also is working to enter new markets and currently has 13 products in development, said Meldrum. Among those products are neurology, dermatology, and autoimmune tests. In addition, it has partnerships with 20 pharmaceutical partners for companion diagnostics. Meldrum noted that the firm already offers a companion diagnostic — its HRD test for predicting chemotherapy response.
Myriad also is on track to launch this year its Melapath molecular diagnostic test to assist pathologists in determining whether a skin biopsy is benign or malignant.
Meldrum reaffirmed the company's full-year revenue guidance for its fiscal year ending June 30. Myriad anticipates revenues of $570 million to $580 million, or 15 percent to 18 percent growth year over year.
Bruker President and CEO Frank Laukien used part of his presentation to highlight the firm's recent efforts in the diagnostics field. A key to this emerging opportunity is its MALDI BioTyper, of which the firm has installed 700 instruments worldwide. The system is used to identify and classify microorganisms and has been on the market for several years. But it has now been cleared for diagnostic applications in Canada, Australia, New Zealand, Taiwan, and Japan, and Bruker is pursuing the CE-IVD Mark for Europe. The firm also intends to file for US Food and Drug Administration clearance for the system as an in vitro diagnostic device in the second half of this year.
The launch of the firm's Evoq triple quadrupole mass spectrometer a few months ago also is expected to further Bruker's reach in clinical proteomics.
Laukien also noted the firm's acquisitions of Skyscan and part of Carestream Molecular Imaging, which provided Bruker with expanded access to the preclinical markets, as well as a partnership with Philips aimed at cardiovascular imaging.
With the recent addition of new members of the management team and a reorganization of its business segments, Bruker is focused on improving profitability and its margins. Company officials didn't disclose details of how they would do that or specific targets, but they did mention during a Q&A after their presentation that the firm's R&D spend is around 11.5 percent of revenues and could come down. In addition, they hinted at potential workforce cuts.
Genomic Health CEO Kim Popovits discussed the firm's efforts to expand its customer base for its OncoType DX Breast and Colon Cancer tests including the firm's expansion outside of the US over the past year. Genomic Health now has distributors covering 80 countries but has gone to direct sales in several international markets, such as France and the UK, according to Brad Cole, the company's COO. He noted that the firm has gone direct in countries where it is getting reimbursement.
Genomic Health also is preparing for a launch this coming spring of its prostate cancer test. It hasn't yet set a price for the test, but officials said it would be disclosed closer to launch and would be "value-based" like its other tests. Popovits also said the firm hadn't yet discussed pricing with payors. Cole said the sales force for the prostate test would be small at first — perhaps 8 to 10 sales people, and would expand as it received positive reimbursement decisions.
After announcing earlier in the day that it had surpassed its 2012 goal for placements of the QiaSymphony with 750 installations at the end of the year, Qiagen CEO Peer Schatz said that the company expects more than 1,000 placements by the end of 2013. He said that eventually it expects reagent pull-through for the system to average between $150,000 and $200,000 annually.
Schatz said that the company is on track for a launch later this year of its own sequencing systems specifically for clinical applications. Qiagen is developing its systems to be compatible with its QiaSymphony and QiaCube platforms. It will leverage tests the firm already sells using other molecular technologies, said Schatz, and will complement its real-time PCR assays.
The new system is "just a different version of the QiaSymphony platform," said Schatz, and is based on sequencing-by-synthesis IP that Qiagen owns.
Schatz also noted that the firm recently submitted applications with the FDA for its TheraScreen and Quantiferon CMV assays. The Quantiferon test builds on a tuberculosis test Qiagen already sells based on the Quantiferon technology.
Doug Berthiaume, president, chairman, and CEO of Waters, said in his presentation that the company's revenue in 2013 is expected to grow in the low to high single digits while EPS is anticipated to grow by as much as 15 percent.
After a challenging 2012, Berthiaume sounded a comparatively optimistic note for the year ahead. In response to questions during the firm's break-out session, he said that indications are that its business in India, as well as the mass spectrometry space, particularly in high-end instruments, would rebound this year.
Berthiaume said that the company's high-end mass spec platforms were hurt in 2012 by competition from Thermo Fisher Scientific's Q Exactive LC-MS/MS system, introduced during the spring in 2011. Waters believes, however, that its products bring new capabilities to the table and that segment of the market will gradually respond and sales will rise. Berthiaume added that recent activity makes Waters "more competitive than we were" in 2012, though he was vague on what that activity was.
Waters' lower-end mass spec business has been stable, he added, while the mid-end platforms, such as triple quadrupoles, have done "very well," particularly the Xevo TQ-S.
Berthiaume also said that Waters will continue its normal R&D spending for the foreseeable future at its historical rate of between 5 percent and 6 percent of sales.
Lastly, while competitors Thermo Fisher and Agilent during the past year began offering a quarterly dividend to shareholders, Berthiaume nixed any idea that Waters would do the same. He said that the response from the investor community to such a move by his company has been "less than overwhelming."