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Piper Jaffray, Mizuho Initiate Coverage of CareDx with Bullish Outlooks

NEW YORK (GenomeWeb) – Piper Jaffray and Mizuho Securities today initiated coverage of transplant molecular diagnostics firm CareDx with bullish views of the company's stock and market opportunities for its tests.

Piper Jaffray's William Quirk put an Overweight rating and a $13 share price target on CareDx's shares, while Mizuho's Peter Lawson rated the company's stock at Buy and gave it a $15 price target.

CareDx went public in mid-July with an offering of 4 million shares at $10 per share.

Quirk said in a research report that while CareDx has enjoyed initial success with its AlloMap non-invasive heart transplant monitoring test in the $90 million domestic heart monitoring space, "we view the expected FY 16 launch into the [approximately] $1 billion domestic kidney transplant monitoring market as the larger catalyst for the company."

AlloMap is a blood-based gene expression test used to monitor heart transplant recipients for acute cellular rejection that was cleared by the US Food and Drug Administration for marketing in 2008.

According to Quirk, the test is only 49 percent penetrated into the market of people who are in the first year of getting a heart transplant, and 18 percent penetrated into the maintenance population, "leaving plenty of room for growth." In total, about 177 million lives are covered for the test by payors, and as CareDx secures more positive reimbursement decisions, adoption of AlloMap will increase, he said.

CareDx is in the process of launching AlloMap outside of the US with partnerships in Canada and Europe, and though Quirk's expectations for the overseas opportunities for the test are conservative, "we see better-than-expected penetration as potential upside to our forecast."

Additionally, CareDx has intentions to address the kidney transplant monitoring market with a cell-free DNA-based test, which is currently available as a research-use-only test. Quirk said that initial data from a CareDx trial is "very promising with kidney transplant rejection patients showing a 3x increase in donor-derived cfDNA," and as more data becomes available, he anticipates CareDx "to leverage this technology (longer term) for the launch of additional organ transplant rejection assays (e.g. liver, lung)."

In initiating coverage of CareDx, Mizuho's Lawson also took note of the potential upside of AlloMap sales through greater market penetration and increased patient use, as well as new market opportunities for the planned cfDNA test for both kidney and other organ monitoring. He also said in a report said that as a first-mover, CareDx is the "established market leader" in the molecular heart transplant monitoring space "with a high barrier of entry coming from 1) established reimbursement, and 2) clinical acceptance."

He estimated that in the first-year heart transplant space, the number of patients will grow at about 1 percent annually and that penetration of AlloMap into this market will reach 58 percent by 2017. In the maintenance space, the number of patients is also projected to grow annually at 1 percent, and AlloMap's share of this market will reach 29 percent by 2017, Lawson said.

He noted that CareDx faces risks associated with the cfDNA test, as it is early phase "and may fail to clear efficacy/utility hurdle rates for adoption," and there is the potential for a delay in revenue ramp resulting from a lag in revenue recognition from clinical labs. Also, he said the cfDNA space is a crowded one "at least in the prenatal testing arena, with inherent IP issues."

However, Lawson sees CareDx "as well positioned in high-growth DNA testing and transplantation markets that should be relatively insulated from competition in the near- to midterm." The company has an established market position, a new product cycle, and upside to legacy tests, he added.

In afternoon trading CareDx shares were up 2 percent at $10.19 on the Nasdaq.