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Fulgent Genetics Details Diversification, Expansion Strategies

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NEW YORK – Having won a stunning amount of RT-PCR COVID-19 testing in 2021, Fulgent Genetics expects to accumulate $1 billion on the balance sheet by the end of the year. The Temple City, California, firm now plans to direct this windfall to further grow its core business on numerous fronts.

On a call to discuss its third quarter earnings on Tuesday, Fulgent officials described the firm's deepening expansion into new market spaces, as well as headcount and footprint growth both in the US and in China.

Traditionally focused on next-generation sequencing-based pediatric rare disease testing, Fulgent had grown its revenues severalfold during the pandemic through its COVID-19 RT-PCR business. It expects to branch further into oncology testing and to also expand its pharmaceutical and clinical research support services business.

Specifically, Fulgent outlined an upcoming launch of a liver cancer liquid biopsy assay, growth of its new oncology testing lab business, strategies for reimbursement, and development of an end-to-end pharma research support business that includes biomarker discovery.

The liver cancer assay in development is part of the firm's new commercialization and co-branding partnership with Helio Health. The test, called Helio Liver, detects 28 genes from 77 methylation sites using next-generation sequencing, Brandon Perthuis, Fulgent's chief commercial officer, said on the call.

Liver cancer is frequently detected using ultrasound imaging approaches, but this method has a sensitivity as low as 40 percent, Perthuis said.

However, in a recent blinded, multicenter validation study including a total of 303 subjects, Helio Liver showed a sensitivity of 76 percent for early-stage liver cancer, 92 percent for late-stage disease, and an overall specificity of 91 percent.

"These numbers could improve as we gather more data but are already showing major improvement over ultrasound," Perthuis said.

In addition to enabling earlier diagnosis — which improves outcomes and reduces the cost of care — the liquid biopsy test could also be beneficial for screening and surveillance of high-risk patients, who otherwise must travel to medical centers for ultrasound, Perthuis said.

"The Helio Liver test is a simple blood draw that can be done at any physician office or phlebotomy service," he said.

To support the launch of Helio Liver later this year, Fulgent plans to bring on 10 new sales managers. The new team will target a subset of the approximately 7,000 hepatology providers in the US with potential secondary call points among the 15,000 gastroenterologists, Perthuis said.

"We invested in data resources to assist in our account targeting and planning, allowing us to focus on those high-volume physicians with high spend on ultrasound and MRIs," he said.

Fulgent sales people will also focus their efforts on key markets with high rates of hepatocellular carcinoma, specifically, New York, California, Illinois, Texas, and Florida, Perthuis said, but added that overall the rollout of Helio Liver will be nationwide.

"As we gain sales experience during the early launch, we anticipate the number of sales people to expand rapidly," he said.

Fulgent's oncology lab business — which was christened when the firm acquired Jupiter, Florida-based CSI Laboratories last quarter — will also expand. The firm announced last quarter that it will increase the physical footprint of the business by building a new lab in California to support national expansion of CSI services beyond the Southeast.

Perthuis said the CSI sales team has traditionally been small with three to four salespeople. In the third quarter, Fulgent doubled the size of the current team, and it plans to double it again in Q4.

"We believe we have superior turnaround time, service, and quality for cancer diagnostics, and look forward to leveraging an expanded sales team to take the services national," he said.

Fulgent is also actively pursuing reimbursement from insurance companies, CEO Ming Hsieh said on the call. "We are encouraged by the expanded relationship we have with third-party payors and look forward to building on this momentum as we continue to scale and expand our test menu," he said on the call.

Currently, the firm is in-network in some locations and boasts 160 million lives covered under insurance contracts, Hsieh said.

"We continue to put effort into becoming more in-network," Perthuis said. "We continue to go after smaller regional contracts, some of the Blue Cross Blue Shield contracts we don't have yet; we do have resources working on that on a daily basis to continue to improve and increase the number of covered lives we have," he added.

While the Helio partnership and the firm's joint-venture in China focus on next-generation sequencing, CSI supplements Fulgent's expansive NGS testing menu by offering 400 unique tests in molecular oncology, flow cytometry, FISH, cytogenetics, and histology.

Branching into yet another testing modality, the firm recently expanded into proteomics through a partnership with Olink Proteomics, which has designated Fulgent as a certified provider of its full suite of Olink products.

Fulgent plans to offer Olink assays in the US and in China, in part to support an "end-to-end" service for pharmaceutical development.

Specifically, pharmaceutical and clinical researchers can use the Olink high-throughput biomarker discovery technology for research and clinical trials while simultaneously testing the same samples using Fulgent's suite of assays: whole genome, whole exome, and RNA sequencing, tumor profiling, methylation sequencing, liquid biopsy, and pathology services. In this way, Fulgent plans to create "a one-stop shop for pharma and clinical research customers," Perthuis said.

"This partnership will make it faster, easier, and more efficient for researchers to carry out their projects, as it enables them to send their samples to one location and access all of their results from one portal," Perthuis added.

Fulgent expects to continue to take advantage of its foothold in COVID-19 RT-PCR testing as long as the opportunity exists.

On the call, Perthuis said that the firm completed 2.2 million COVID-19 tests in the third quarter due to Delta variant-related increases in SARS-CoV-2 incidence.

Nevertheless, he acknowledged that "symptomatic testing ebbs and flows with the positivity rate" and said that the firm expects to capitalize on "more predictable long-term contracts," like back-to-school and back-to-work programs.

Fulgent is currently supporting more than 1,000 school testing programs, he said. It has also launched an online dashboard platform that enables employees to upload either vaccination documentation or weekly testing results to help employers track compliance.

The firm now continues to evaluate a pipeline of assets, Perthuis said, and it expects to see continued activity on the M&A and strategic investment front.

Although share buybacks are on the table, Fulgent's first priority is to reinvest its COVID-19 windfall. CFO Paul Kim suggested an announcement of a deal before the end of the year is "certainly a possibility."

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