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Meridian to Increase R&D Investments as It Starts Planning for Next-Gen MDx Platform

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NEW YORK (GenomeWeb) – Meridian Bioscience marked its newly declared era of transparency earlier this month by holding the firm's first-ever conference call to recap its earnings. After one year at the helm, new CEO Jack Kenny used the call to announce a series of strategic business changes, including a plan to drive growth through directing profits to R&D projects rather than paying a locked-in dividend.

Investment analysts subsequently weighed in with cautious optimism that the new leadership team may bring about a culture shift at Meridian that may ultimately help the firm compete better in the diagnostics space.

Meridian Bioscience became a publicly listed company in 1986, and Jack Kraeutler previously headed the Cincinnati-based firm, serving as CEO for 24 years beginning in 1992.

New CEO Jack Kenny was appointed a year ago, upon Kraeutler's retirement. Kraeutler preferred to report out earnings and then talk to a few analysts one on one, rather than having a recorded call, Kenny said in an interview following reporting the firm's fiscal fourth quarter and full year earnings. When he came in a year ago, Kenny said he wanted to focus on the business for the first fiscal year. But, going forward, the firm will hold calls every quarter.

"In talking to people on the Street, there was a strong desire to increase transparency, and one of my goals internally in the company, but also externally, is to improve the transparency for Meridian," Kenny said in the interview.

Indeed, Bill Quirk, an analyst at Piper Jaffray who follows Meridian, noted in a separate interview that the public recorded conference call format may also allow the company to disclose things that they are not permitted to in a one-to-one basis.

"In a public conference call format, generally speaking, management teams have more flexibility to talk about additional plans and nuances of business," said Quirk. "It opens up the conversation and engages the sell side as well as the buy side."

The higher-level business strategy changes Kenny described on the call and in a follow up interview included initiatives such as redirecting excess cash into research and development instead of dividends with a goal of expanding R&D investment from 7 percent to 10 percent of revenues. The firm has also undertaken a rebranding effort and plans to launch an improved website in the near future.

"We believe — and we think the market generally believes — that Meridian was underinvesting in the growth of the business," Kenny said. "We have paid a very significant dividend for years, and a high percentage of the profit generated has gone back to dividends," he added.

With a focus on expanding its product portfolio, the firm's new SVP of R&D for Diagnostics, Larry Mertz, had previously been at BD for a number of years and will now spearhead the development of a next-generation molecular platform to someday replace the firm's Illumigene system.

"The Illumigene has been a great product for us for the eight-plus-years that we've had it," but "there are more manual steps, and it is less automated to run higher volumes," Kenny said.

For the firm's next approach to molecular, "the intent is to have a sample-to-answer approach," Kenny said, as well as walkaway capability, and to simplify the workflow down to only a few steps.

The transition will take a bit of time and depends on whether the firm develops the technology internally or externally, so Illumigene will be part of the business for at least the next few years.

"To change priorities for excess cash ... from a focus on dividends to reinvesting in the business, as well as looking externally through tuck-in deals, I think is a great idea, and certainly something that we've been asking the company to do for some time, in part because of the changing competitive dynamic," Quirk said.

Illumigene has suffered from the hands-on time it requires, he added. "When Illumigene was released, it was a fine product for those new-to-molecular accounts and perhaps lower-volume accounts," Quirk said. But the challenge now is that molecular "has been shifting towards automation for almost a decade now, particularly at the high end, and that has worked its way into medium- and lower-volume," Quirk said, citing Cepheid's GeneXpert and Quidel's Savanna systems as examples of this.

"I agree with the company that they have to move to a new platform that has better total hands-on time," said Quirk. The seven steps of the Illumigene workflow are spread through the total run time, requiring a technician to be nearby throughout the assay. "I think that is a big reason Illumigene never blossomed into the asset that they thought it would be," he said.

Kenny emphasized that the firm has not yet figured out if it will get from point A to point B with this new platform through in-house development or perhaps a small tuck-in acquisition.

Meridian is also investing more in R&D for its other business. "We do believe there are some smaller strategic bolt-ons ... that perhaps we could look into acquiring and integrating them into our life science business," Kenny said. 

Kenny said the firm plans to build out its instrument portfolio and test menu in a way that increases the diversity of its offerings to better appeal to integrated delivery networks (IDNs).

Quirk noted that, overall, it is important that the management team recognizes some of the shortfalls in the Illumigene system, and "between some things they've talked about internally and of course quite a few potential external targets, predominantly private, our suspicion is that they are probably going to be able to find a replacement for Illumigene."

However, the challenge is that, beyond FDA approval, "in order to compete with entrenched competitors you really have to start to think about menu, how rapidly you can build up that menu, and of course, speed, automation, and cost of goods are all very important considerations when you are looking at deals like this," Quirk said. "I think we are going to see the menu develop more before we can really opine on the effectiveness of the strategy within that important customer base," he said.

In the gastrointestinal testing space, in particular, the company plans to develop a "deep" menu, particularly to appeal to IDNs, Kenny said.

"If you look in the GI space, companies like Cepheid, for example, do C. diff, they do a test or two, or if you look at BioFire, they have one panel that does basically everything in GI. … But IDN's don't want just one test for everything, or the occasional test," Kenny suggested.

Meridian is instead planning to build up a comprehensive GI menu that has everything from single tests — both immunoassay and molecular — all the way up to bacterial or viral molecular "smart panels," that have a moderate number of targets that is in line with the current reimbursement climate. The company will also develop its menu around antibiotic resistance testing, Kenny said.

Overall, with the GI menu Meridian will drive toward more differentiation, higher margins, and lower-volume assays. This diversified menu will support large hospital labs requiring molecular systems as well as outlying sites that lack skilled technologists or lab-based instruments, according to Kenny. For example, they could provide IDNs stand-alone Enterotoxigenic E. coli (ETEC) or Campylobacter tests to be used in a physician office as well as a more complex molecular panel that can be run in a core lab.

In addition, Meridian plans to focus on developing a more limited menu of respiratory infection assays. But here it sees opportunities with more price-sensitive, high-volume assays, Kenny said. This includes targets like Group A Strep and influenza, and extends across the immunoassay and molecular platforms.

In terms of other diagnostics platforms, Meridian also continues to develop its Curian automated immunoassay reader, Kenny said. It anticipates bringing the product, with an initial focus on C. diff testing, to market in early 2020, Kenny said. The test will have fewer processing steps than some of the other assays on the market, providing an improved workflow, he said. 

Meridian is also developing a new platform to address point-of-care testing needs in pediatric offices. The firm's Pediastat instrument, which is currently in development, represents the next generation of its lead care testing business that was acquired from Magellan.

"The next generation is intended to run not just lead but also other assays that are important to a pediatrician," such as hematocrit, bilirubin, or cholesterol, Kenny said. "Those are the kinds of tests we're looking to be able to consolidate," he said. The firm first needs to get through remediation with the US Food and Drug Administration for its venous blood lead testing product, a process that it noted in the earnings call should be completed in the spring of 2019. 

Magellan had a large footprint in pediatrician offices that Meridian hopes to continue to leverage. But the firm is also orienting itself to the trend it sees of hospitals buying up physician offices. Pediatricians in these environments also need to connect into the health system's information system as well.

Quirk confirmed that this general trend is still going strong, noting that the number of physicians practicing independently has gone from something on the order of 70 percent to less than 50 percent today.

Meridian has done two acquisitions in the last decade – BioLine in 2010 and Magellan in 2016 – but Kenny said that, in general, M&A needs to be a more programmatic element of its business. "If we're generating cash and we can use some of it to appropriately buy things to help us build a stronger business, we believe there is a good balance to that," he said.

The firm is now doing a full analysis of internal and external opportunities for its molecular diagnostics business in particular. Ultimately, this could be "a little bit of a larger acquisition, if it was something that made sense," Kenny said, but the firm is not considering any large, transformative M&A move as a first option at this time.