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GenMark Diagnostics Expanding Manufacturing to Meet Pent Up Demand for SARS-CoV-2, Respiratory Panel

NEW YORK ─ GenMark Diagnostics is building three new manufacturing lines to meet exceptional demand for its ePlex molecular diagnostic tests during the pandemic.

The Carlsbad, California-based molecular diagnostic test developer announced it is adding the new manufacturing lines to three it already uses, on the back of a third quarter that saw revenues more than double year-over-year.

Of the different types of tests to diagnose active SARS-CoV-2 infections, demand is particularly hot for sample-to-answer syndromic panels and continues to exceed manufacturers' capacities, Scott Mendel, GenMark's president and CEO, said during a conference call on Wednesday to discuss the company's financial results.

Right now, he said, there are limitations to how many tests the company can produce because supply "has been governed by what we can produce off our consumables [manufacturing lines] …. and also flows into what we're willing to commit to from a placement perspective."

GenMark completed construction for its fourth and fifth manufacturing lines earlier this month, and after the equipment is installed, production is expected to begin on the fourth line later in Q4. The firm expects to begin production on the fifth line in Q1 next year, leading to a capacity of up to 175,000 tests per month. Ultimately, new manufacturing capacity should enable it to boost output to 250,000 tests per month by the middle of next year, Mendel said.

Like other test manufacturers struggling to meet the demand for COVID-19 tests, GenMark has seen an upside to that challenge – unprecedented revenue growth.

According to Mendel, GenMark has been transformed by the coronavirus pandemic and "COVID-19 has accelerated adoption of our ePlex platform well ahead of our pre-pandemic expectations."

A rapid increase in ePlex placements "combined with multiyear contracts that include committed purchase volumes, has created an enduring and predictable revenue stream," he said on the conference call.

As a result, GenMark increased its total revenue guidance for full-year 2020 to a range of $165 million to $168 million, compared to the previously stated range of $155 million to $165 million.

The company expects to achieve the top end of both its global ePlex placement guidance of 230 to 250 net new analyzers and annuity per analyzer of $175,000 to $200,000.

But the onset of the pandemic brought challenges other than the need to quickly ramp up manufacturing. Due to shifting resources because of COVID-19, GenMark's development timeline for a gastrointestinal panel on ePlex has been delayed by six to nine months, Mendel said.

The delay "correlates with the amount of time we've been focused on COVID and [the ePlex Respiratory Pathogen Panel 2, or RP2], as well as satisfying commercial demand," he said, adding that he would provide a clearer timeline for the gastrointestinal panel's development in the future.

Mendel noted that with enough cash flow to fund investments, the firm recently increased the size of its assay team to focus on completing the development of its gastrointestinal panel and other panels in its pipeline.

Going forward, he expects that the firm will be able to launch one to two new panels per year. Mendel didn't specify the types of panels they anticipate developing, but the firm has said in the past that it is interested in panels for central nervous system infections and bone and joint infections.

In addition to its near-term revenue growth, the company is also seeing positive longer-term effects from the increase in testing demand during the pandemic. Mendel noted that about 95 percent of ePlex placements this year included multiyear contracts with volume commitments for the RP2 or blood culture identification panels, or both.

"The company has taken action to ensure that its forward-looking growth profile is driven by its core product offerings, not [just] COVID-19 testing, and [the firm] now holds multiyear consumables contracts that de-risk its growth for the next several years," Canaccord Genuity analyst Max Masucci wrote in a research note on Wednesday.

Masucci said GenMark could see even more demand as more people present to hospitals. Given that its multi-target RP2 panel detects several pathogens that cause respiratory infections, "a rise in hospitalizations for patients exhibiting COVID-like symptoms should drive strong test volumes," he added. 

During 2020, GenMark's revenues have grown consistently year over year on the back of COVID-19 testing demand and sales of its single-target ePlex SARS-CoV-2 test, which received US Food and Drug Administration Emergency Use Authorization in March.

Around mid-year, GenMark announced it was launching RP2, which identifies 21 respiratory pathogens, including for SARS-CoV-2, influenza, and other seasonal respiratory infections.

The company is discontinuing sales of its ePlex single-target test and anticipates only a "few hundred thousand dollars" in revenues from it in the fourth quarter as customers increasingly use the broader respiratory panel, Mendel said.

The transition to a syndromic respiratory panel is going "better than expected," he said, adding that the rate of adoption of the respiratory panel shows that customers increasingly understand the value of syndromic testing.

Additionally, GenMark's BCID panels, which have received US Food and Drug Administration clearance in the past few years, are an important part of its future growth, but adoption occurred at a "slightly lower rate than originally planned as resources shifted toward supporting COVID-19 initiatives," Mendel said.

Nonetheless, the firm is "encouraged by the implementations completed thus far and the growing number of customers contracting for BCID adoption. In fact, more than 40 percent of 2020 year-to-date placements include BCID," he said.

According to Sung Ji Nam, a BTIG research analyst, GenMark is now well positioned in the market for syndromic testing, which also includes competitors such as Luminex, BioMérieux, and Qiagen.

"While COVID-19-related testing provided significant tailwinds [year-to-date] and is likely to provide significant tailwinds into next year, we continue to believe the pandemic has been a major impetus for [GenMark's] accelerated penetration into the addressable market of sample-to-answer syndromic testing in acute care settings," Nam wrote in a research note on Wednesday. "Furthermore, [GenMark] remains well-positioned to take share in the rapidly growing syndromic testing market beyond the pandemic, in our view, leveraging its existing respiratory and BCID" panels and expanding test menu.

She noted that about 50 percent of the ePlex placements this year were to customers new to syndromic testing "whose adoption timelines were likely to have been accelerated due to the pandemic."

Mendel said he believes increasing awareness of diagnostic tools, including syndromic tools, is driving greater adoption during the pandemic. "The pandemic certainly helped encourage some folks to get across the finish line," he said, adding that he believes many who have adopted syndromic testing for the first time may have been previously sending samples to other laboratories for testing and decided to begin testing internally.

Though US-based testing capacity is increasing, most of that increase is coming from high-throughput testing in central laboratories, Mendel said, adding, "There's an increase in capacity but not necessarily in sample-to-answer syndromic" testing.

Against the backdrop of capacity constraints, brisk demand continues for such testing, he added.

The company is seeing adoption of multiple platforms in hospital laboratories, including platforms from manufacturers other than GenMark ─ something it had not seen in the past for the same disease state, Mendel said. This is another effect of there not being "enough capacity in the sample-to-answer syndromic space to satisfy all the demand," he added.