Fulgent Genetics aims to alteration from a genomic diagnostic concern into a fully integrated precision medicine institution focused connected oncology
Fulgent Pharma’s proprietary caller nano-drug transportation exertion level synergistically underpins the combined businesses, perchance providing some near- and semipermanent marketplace opportunities
Fulgent to sermon acquisition connected scheduled net league telephone and webcast contiguous astatine 1:30 p.m. PT
TEMPLE CITY, Calif., November 07, 2022--(BUSINESS WIRE)--Fulgent Genetics, Inc. (NASDAQ: FLGT), a technology-based familial investigating institution focused connected transforming diligent attraction successful oncology, infectious and uncommon diseases, and reproductive health, announced contiguous that it has completed an acquisition of Fulgent Pharma Holdings, Inc. ("Fulgent Pharma"), an autarkic clinical-stage, therapeutics improvement institution focused connected the improvement of innovative crab treatments. Under the presumption of the agreement, Fulgent Genetics acquired Fulgent Pharma for a full acquisition terms of astir $100 million, taxable to adjustments, to beryllium paid with a operation of currency connected manus and shares of communal banal of Fulgent Genetics.
The combined institution plans to connection a vertically integrated solution to combat crab with the imaginable to unlock important semipermanent upside for some the therapeutic and diagnostic businesses, portion efficaciously managing risk. Fulgent Pharma and Fulgent Genetics were antecedently some owned by Fulgent Therapeutics until 2016, erstwhile the businesses were separated up of the Initial Public Offering of Fulgent Genetics. The companies person operated arsenic abstracted entities since 2016, enabling each concern to absorption connected and execute halfway objectives crossed familial investigating and therapeutic cause development. Over the past year, Fulgent Genetics has established a meaningful beingness successful the ample marketplace for molecular diagnostics and oncologic testing, astir notably with the caller acquisitions of CSI Laboratories and Inform Diagnostics, and the opening of a state-of-the-art oncologic investigating installation successful confederate California. Fulgent Pharma has developed a caller nanoencapsulation and targeted therapy platform, which is designed to amended the therapeutic model and pharmacokinetic illustration of caller and existing crab drugs. Based connected existent studies and pre-designated criteria, Fulgent Pharma believes its pb cause candidate, FID-007, has achieved proof-of-concept successful preliminary quality objective trials for the attraction of assorted crab types, including Head and Neck, Ampullary, Pancreatic, NSCLC, and Breast.
"This acquisition advances our ngo to physique a holistic level to supply broad solutions and services crossed the crab attraction continuum, including aboriginal detection, diagnostics, and monitoring, arsenic good arsenic cause find and development," said Ming Hsieh, Chairman and CEO of Fulgent Genetics and co-founder of Fulgent Therapeutics. "With my committedness and our teams already successful place, the operation of these 2 businesses diversifies our assets and will, we believe, supply sustainable aboriginal gross and borderline accidental done a perchance lucrative people oncology market."
"In summation to FID-007, our proprietary nano-drug transportation level has generated a heavy pipeline of wholly owned cause candidates, focused connected further people crab indications, including 1 for colon crab and 1 NCE (new chemic entity) targeting the STING pathway. Both person been tested extensively successful preclinical studies," said Ray Yin, PhD., President and Chief Scientific Officer of Fulgent Pharma and co-founder of Fulgent Therapeutics. "Through this acquisition, Fulgent Pharma volition person entree to commercialized relationships crossed the oncology marketplace arsenic good arsenic superior to money research, improvement and, assuming the requisite regulatory approvals, commercialization arsenic portion of Fulgent Genetics."
Strategic Vision
Attractive Lead Therapeutic Candidate FID-007 and Nanoencapsulation Technology: Fulgent Pharma’s pb program, FID-007, is simply a proprietary nanoencapsulated formulation of paclitaxel developed to amended the wide solubility illustration of paclitaxel. Data observed from studies conducted to day suggest that nanoencapsulation of paclitaxel whitethorn amended the biodistribution and bioavailability to people tissues. Such information besides show a favorable illustration and further enactment imaginable applications successful a wide scope of indications including Head and Neck, Ampullary, Pancreatic, Lung, Breast, and Ovarian cancers.
Expanded Market Opportunity: FID-007 is presently being developed for 2nd and 3rd enactment attraction of Head & Neck (H&N) cancer, a imaginable $2.2+ cardinal people marketplace opportunity. The institution sees further opportunities successful ample multi-billion markets including NSCLC, Pancreatic, Breast, and Ovarian cancers wherever presently disposable therapies are suboptimal.
Strategic and Operational Synergies: Potential semipermanent worth instauration driven by the operation of therapeutic candidates and diagnostics expertise, designed to connection a broad oncology-focused solution that enables precision medicine done in-house oregon partnered therapeutics programs underpinned by familial information insights. In addition, Fulgent Pharma’s talented technological squad brings unsocial expertise to the combined businesses and creates a differentiated vantage successful the oncology market.
Enhanced Commercial Profile: Following completion of improvement and regulatory approval, the combined institution is positioned to beryllium a "one-stop shop" that spans the beingness sciences concatenation and reaches the expanded lawsuit basal of Fulgent Genetics done its increasing income organization.
Attractive Capital Allocation Plan: Fulgent Genetics’ beardown equilibrium expanse and currency flows from operations are expected to beryllium capable to enactment the advancement of Fulgent Pharma’s R&D pipeline. Fulgent Genetics’ way grounds of integrating acquisitions, strategical partnerships, and disciplined execution has been a cardinal constituent successful the company’s growth. This acquisition is designed to align with Fulgent Genetics’ strategy to thrust agelong word shareholder worth done integrated and inorganic initiatives crossed the genomics and, assuming the requisite regulatory approvals, therapeutics marketplace segments.
Advisors
A peculiar committee comprised of autarkic members of Fulgent Genetics’ committee of directors was established to reappraisal this transaction. In consultation with its autarkic fiscal and ineligible advisors, the peculiar committee recommended the committee of directors o.k. the Fulgent Pharma acquisition. The peculiar committee was advised by First Principles Advisory Group and Cooley LLP. Fulgent Genetics was represented successful the transaction by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.; and Procopio, Cory, Hargreaves & Savitch LLP acted arsenic ineligible counsel to Fulgent Pharma.
Conference Call Information
Fulgent Genetics volition sermon this transaction during its scheduled 3rd 4th 2022 net league telephone and webcast being held contiguous astatine 4:30 PM ET (1:30 PM PT). The telephone and associated presumption whitethorn beryllium accessed done a unrecorded audio webcast connected the Investor Relations conception of the company’s website, http://ir.fulgentgenetics.com. An audio replay volition beryllium disposable astatine the aforesaid location.
About Fulgent Genetics
Fulgent Genetics is simply a technology-based familial investigating institution focused connected transforming diligent attraction successful oncology, infectious and uncommon diseases, and reproductive health. Fulgent’s proprietary exertion level has created a broad, flexible trial paper and offered the quality to continually grow and amended its proprietary familial notation library, portion besides maintaining accessible pricing, precocious accuracy, and competitory turnaround times. Combining adjacent procreation sequencing ("NGS") with its exertion platform, Fulgent performs full-gene sequencing with deletion/duplication investigation successful an array of panels that tin beryllium tailored to conscionable circumstantial lawsuit needs. A cornerstone of Fulgent’s concern is its quality to supply expansive options and flexibility for each clients’ unsocial investigating needs done a broad exertion offering including unreality computing, pipeline services, grounds management, web portal services, objective workflow, sequencing arsenic a service, and automated laboratory services.
About Fulgent Pharma
Fulgent Pharma began arsenic Fulgent Therapeutics successful Temple City, California, successful June 2011. As the institution progressed into the sphere of personalized medicine, it besides started delving into objective familial investigating - a earthy complement. In 2016, Fulgent Therapeutics divided into 2 abstracted entities - Fulgent Pharma and Fulgent Genetics - successful bid to amended prosecute their autarkic objectives. Today, Fulgent Pharma is afloat focused connected perfecting cause candidates for treating a wide scope of cancers. Its partners successful this endeavor see the University of Southern California, Moffitt Cancer Center, and ANP Technologies.
About FID-007
FID-007 consists of paclitaxel encapsulated successful a polyethyloxazoline (PEOX) polymer excipient designed to heighten PK, biodistribution, and tolerability. In summation to allowing the cause to stay successful solution until it tin participate a crab cell, the PEOX nanoparticle is designed to preferentially present paclitaxel to the tumor done the leaky hyperpermeable vasculature.
Forward-Looking Statements
This property merchandise contains forward-looking statements wrong the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements successful this property merchandise see statements about, among different things: management’s and others’ beliefs, judgments, and estimates regarding Fulgent Pharma’s business, prospects, exertion platform, therapeutic candidates, therapeutic candidates’ worth to Fulgent and their imaginable payment to Fulgent’s business, platform, services, products and merchandise candidates; semipermanent visions and strategies, including, with respect to Fulgent Pharma, those designed to make a vertically integrated solution for crab care, the objective improvement of Fulgent Pharma’s pipeline, and related statements and assumptions regarding improvement timelines, perchance accelerated pathway for regulatory approval; the imaginable information oregon efficacy of the nano-drug transportation level and immoderate related therapeutic candidates; the imaginable marketplace size for these candidates and platforms and the worth of disposable data, including genomic data; Fulgent’s investigating solutions and services, including its laboratory capableness and related matters; Fulgent’s recognition and valuation of opportunities, estimates of marketplace size oregon covered lives, and its quality to capitalize connected opportunities to turn its business.
Forward-looking statements are statements different than humanities facts; they subordinate to aboriginal events oregon circumstances and to Fulgent’s and/or Fulgent Pharma’s aboriginal performance; and they are based connected management’s existent assumptions, expectations, and beliefs concerning aboriginal developments and their imaginable effect connected Fulgent’s business. These forward-looking statements are taxable to a fig of risks and uncertainties, which whitethorn origin the forward-looking events and circumstances described successful this property merchandise to not hap and existent results to disagree materially and adversely from those described successful oregon implied by the forward-looking statements. These risks and uncertainties include, among others: the imaginable interaction of the announcement oregon consummation of the acquisition connected relationships with 3rd parties, including employees, customers, partners and competitors; inability to clasp cardinal personnel; changes successful authorities oregon authorities regulations affecting the acquisition oregon the parties; economic, social, oregon governmental conditions that could adversely impact the acquisition oregon the parties; Fulgent Pharma whitethorn not nutrient the anticipated benefits discussed successful this release; Fulgent Pharma’s therapeutic candidates whitethorn not recognize the anticipated benefits discussed successful this merchandise oregon whitethorn endure delays that materially and adversely impact their aboriginal commercialized viability; the integration of Fulgent Pharma whitethorn devour much absorption and different resources than anticipated; the imaginable of oncology markets; oncology markets whitethorn not turn astatine the rates anticipated; the ongoing impacts of the COVID-19 pandemic, including the preventive nationalist wellness measures that whitethorn proceed to interaction request for Fulgent’s genetics tests and the pandemic’s effects connected the planetary proviso chain; the marketplace imaginable for, and the complaint and grade of marketplace adoption of, Fulgent’s tests, including its tests for COVID-19 and familial investigating generally; Fulgent’s quality to vie successfully, including its quality to proceed to make caller tests that are charismatic to its assorted lawsuit markets and its quality to support turnaround times and different support gait with rapidly changing technology; Fulgent’s quality to successfully integrate acquired businesses and assets, including Fulgent Pharma, into its concern strategy and to deduce worth from its investments; Fulgent’s quality to support the debased interior costs of its concern model, peculiarly arsenic Fulgent makes investments crossed its business; Fulgent’s quality to support an acceptable borderline connected income of its tests, peculiarly successful airy of expanding competitory pressures and different factors that whitethorn proceed to trim Fulgent’s merchantability prices for and margins connected its tests; risks related to volatility successful Fulgent’s results, which tin fluctuate importantly from play to period; risks associated with the creation of Fulgent’s lawsuit base, which tin fluctuate from play to play and tin beryllium comprised of a tiny fig of customers that relationship for a important information of Fulgent’s revenue; Fulgent’s quality to turn and diversify its lawsuit basal and summation request from existing and caller customers; Fulgent’s investments successful its infrastructure, including its income enactment and operational capabilities, and the grade to which these investments interaction Fulgent’s concern and show and alteration it to negociate immoderate maturation it whitethorn acquisition successful aboriginal periods; Fulgent’s level of occurrence successful obtaining sum and capable reimbursement and collectability levels from third-party payors for its tests; Fulgent’s level of occurrence successful establishing and obtaining the intended benefits from Fulgent Pharma, partnerships, associated ventures, oregon different relationships; Fulgent’s compliance with the assorted evolving and analyzable laws and regulations applicable to its concern and its industry; risks associated with Fulgent’s planetary operations; Fulgent’s quality to support its proprietary exertion platform; and wide industry, economic, political, and marketplace conditions. As a effect of these risks and uncertainties, forward-looking statements should not beryllium relied connected oregon viewed arsenic predictions of aboriginal events.
The forward-looking statements made successful this property merchandise talk lone arsenic of the day of this property release, and Fulgent assumes nary work to update publically immoderate specified forward-looking statements to bespeak existent results oregon to changes successful expectations, but arsenic different required by law.
Fulgent’s reports filed with the U.S. Securities and Exchange Commission ("SEC"), including its yearly study connected Form 10-K for the twelvemonth ended December 31, 2021, filed with the SEC connected February 28, 2022 and the different reports it files from clip to time, including subsequently filed quarterly and existent reports, are made disposable connected Fulgent’s website upon their filing with the SEC. These reports incorporate much accusation astir Fulgent, its business, and the risks affecting its business.
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Contacts
Investor Relations Contact:
The Blueshirt Group
Melanie Solomon; melanie@blueshirtgroup.com
English (US)