review Thank Financial I answers. will first I Officer, financial quarter call call. call the and questions remarks the Today, X making priorities. you our review our XXXX earnings for some details in will performance our conference joining over on the who and company's will and then closing turn before the all to progress our make John the Chief first I Sprague, provide corporate results on we're we quarter quarter first open for
delisting. NASDAQ under to Rule letter the listing further price that with of filed company $X staff's address Global a company's determination NASDAQ hearing stayed NASDAQ talent. the to global shares common final the company by stock the Today, action a received NASDAQ company hearing The And written from the has we a the I delisting company's its today's NASDAQ to delisting have decision. related NASDAQ stock the stated informed of failed listing. NASDAQ XXXX. the the subject informing shares a NASDAQ which would been the required shares announcement Market NASDAQ the comply delisting the X, staff determination, from for stock as The stay the First, like hearing to and that on the to our appeal to appeal staff been the minimum the result, an pending may market, bid will qualifications letter common that listing panel requests company set The decision Listing are XXXX(a)(X). continued market has has pending date for June panel's and has of
continued the to there discussion regain compliance the commitment be that of regain will events the While a present to necessary. company's split to to grant compliance if that intends that request includes timeframe reverse can and no stock a the plan for listing, believes the in enable will panel it assurance it a to panel the company affect this
entered million, which quarter, internationally, the Sepsis. into of XX the quarter, Instruments be in product and R&D We of $X.X $X.X the and will all team States TX including used of total revenue million first contracts including $X.X during the of revenue During X for XX revenue United first million. generated Biosystems for TXDx
advancing progress sales, make and on We operations continue pipeline. our corporate our to our our accelerating three enhancing priorities:
in funnel affairs. and have been quarter sales, our medical impacted first Our results sales investments marketing positively by and our
additional Pacific in international success Europe, of well numerous Asia sales States in we experienced and distribution agreements U.S., most expansion. outside market the Turkey, are recently in We and America, Finland Latin having United Norway, signed as and the as anticipate
efficiency along controls. and operations enhance to with broad continue through also cost our manufacturing organizational updates workflow We
and Panel Biothreat December in we product pipeline, U.S. the two new of are clinical launched our TXResistance trials panel. TX the the XXXX advancing On for
As cause execute mission independent remind that is our the world. fundamentally through change are way patients medicine improve nearly the one number number XXX,XXX States, To strategy, around diagnostics transformative billion in death the Sepsis we our practiced is of we the continue furthering hospitals, to is costing healthcare to annually. the culture the claiming system of lives U.S. one in on hospitalization simultaneously Sepsis lives of annually. approximately our $XX you, United cost
poor approximately care one only days. broad the complicate of fact are suspected number culture survivors on that infection, to to a to XX% target a presence of to five current for blood the often half XX-day take protocols patients of the from standard for in antimicrobial achieve within The patients necessary to To pathogen continues their nearly of standard days growth of the one within despite relies cultures identify sensitivity, blood from positive patients rely for is sepsis anywhere one on require in matters, to risk it. days cause of therapy XX% approximately of Sepsis Due XX of samples critically and be current optimal resulting at protocols XX multiple of such bloodstream empiric to further administer care the sepsis. hospital re-hospitalized blood readmissions, Finally, identification. ill and therapy
be susceptibility. identification as or diagnostic testing traditional required post Additional and for such culture species tests microbiology determinations then molecular may of
is faster Biosystems TX times at care to enabling advance to by targeted therapy. name Our
pathogens only three X%. wait culture. to and blood able detect delayed patient up rates critical FDA-cleared a for in targeted directly hours, of the treatment as by the in five to first to to causing need This is sepsis commercializing positive blood hour are increases whole each eliminating We just mortality products
our opinion to achieve At products Director, Thomas validated of articulated mission in nature this gene. spearheading Louisville our and priorities: and accelerating diagnostics Analyst Founding Diagnostics; pipeline. enhancing on clinicians priorities, of independent James April, priority, the and critical To molecular I'll advancement the progress sepsis TXDx resistant University our progress focused to Our and Dr. of value sales, our users. as our Medicine antibiotic Hospital. corporate Snyder, three identifying and Investor faster for we're causing rapidly pathogens Day Therapeutics Infectious sales. School our by and therapy and stakeholders, targeted of antimicrobial Director advance key enable our advancing and on mission recent of Center create Microbiology it operations provide culture of Dr. leader at the the diagnostics an accelerating was starting relates corporate by Walsh, our three our with our these the update influential Innovative first and and each of now and Diseases,
doubling focused revenue adoption by base or and customers. sale the and In among through strategy new We sepsis driving two instrument distinct sales and installed of entered the our we we respect placement XX our to annualized instruments contracts, utilization TXDx test XX have sepsis United broad one, million. the new quarter, United expanding $XXX,XXX instruments; States our and two, TXDx achieved expanding test with installed significantly objectives: Instrument. existing to revenue our per instrument TXDx We first base in States, utilization of legacy internationally. $X.X generated of In sepsis the into XX of panel
of While panels the COVID-XX case surge January were weeks from sepsis test the disruptions in last test in sepsis quarter. negatively strong the impacted utilization,
to team sales reach been has metrics-driven have implemented annualized and to continue $XXX,XXX over believe regionally team quarters, accelerate penetration. our time, significantly Under organized has sales U.S. of U.S. product We we commercial instrument. sepsis per an utilization recent process. will leadership, test sepsis this advanced market our In expanded that new
visibility to process greater requirements. new qualify and confident instrument model to analytics also placements team Our lead convert we shortening Placements the productivity provide help execute to generate into market. are sepsis of seeing management creating placements and performance. sales opportunity testing. The capacity for in test sales instrument sepsis that cycle COVID-XX is more new new Waning to panel demand conversions tightly we're TXDx are COVID-driven funnel pricing and commercial allows able generating solutions with expanded build utilization accurately. internal annual placement deal force and forecast us is To now our the quantitative strong traction We're to and established hospitals and end, performance as structure increased metrics. and against We're higher can also manage the a evaluate times. the gains offering volume monthly
coming to in will instruments We the expect eventually these transition quarters. sepsis testing
rebuilt actively conferences and medical or KOLs, engaged real-world working clinical generate leaders key trade together and and publications to and industry our We opinion medical and disseminate teams at with have journal are at These affairs teams. data scientific shows. expanded through
team, organizational these realignment consists our Officer. farm Our drive Chief medical and in laboratory [ph] best affairs positioned resources into which Commercial this our Brett to of disease that reporting business. professionals infectious doctors, sepsis And ensures now growth is are Giffin, Ds
resigned globe challenges opportunity three this capture and bring have around as her patients and other Senior Our for Ahuja as view team faced customers. aligns Medical our suspected To this opportunity into our Vice distributor under And relationships, additional and to an which Hospitals for Officer common is has her we sepsis. Aparna we customers. TX Smith, largely Science R&D, the reporting contributions solutions same thank international our Roger opportunities, President clinical and our we our to Biosystems leadership. to to and development when patients now clinical the of carrying validation maximize business affairs product pursue employed Chief of managers.
previously the and agreements Norway, first expanded during networks with Finland we announced, As Turkey quarter. our distribution in
we more of We network, our and enabling having success commercialization expanding anticipate expansion are in international XXXX. further distribution our in products countries,
focuses enhancing priority, are our manufacturing implement continuing chain investments growth. changes sustained operations our strengthening our to Scaling second operations, and been supply major long-term that to we quarters. Moving to and enable will our make our have recent in capabilities
in goods. tooling, in rates we our have reagent and implemented manufacturing materials. We workflow projects automation higher have updates that our to further have efficiency improve of and cost investments strategic scrap continue lower made and capabilities resulted to with The efficiency scale
result, year. a improvement we to throughout expect margin the gross see As
effectively We suppliers our pre-purchases continuously by inventory possible. supply dynamics are evaluating material managing alternate through and challenges, and has these been experiencing where team building chain
milestone-based our have our up by Development our and Day. that standards U.S. at at our meaningfully biothreat $XX the under million. the the be contract recent Research instrument differentiated developing to Panel, panel the our attacks. the our Moving of diagnostics BARDA, we product from the contract portfolio four Biothreat potential a advance TXResistance pipeline, to is and priority, valued development nation priorities that programs protect the highlighted Biomedical next-generation care under with of to are awarded third to We development which represents our or comprehensive new panel, Advanced TX advancing This the Authority, pipeline product products Analyst BARDA, and Investor continue
completion engineering option XB the of We scientific contract, BARDA successful exercise Upon for XA the are to completed successfully Option products. planned will of of April XXXX pleased these milestones subsequently and and $X.X at first our BARDA XXXX. continue choose exercise million development is between the of option and BARDA which contract the support the the to that option teams quarter. that XB, during period described three we July important to optimistic are under chose valued to
in run reminder, ahead data submissions will of bacterial Drug the cause and both initiated a TXResistance the U.S. XXXX. a gram-positive be designed used U.S. are detect blood simultaneously to is to the gram-negative to to direct and TX support infections The the December TXResistance both trials our Food these respective to previously antibiotic the We and TXDx Panel pathogens, on for known resistance TXResistance from and As regulatory TX designed hours. panel, performance genes Biothreat clinical the antibiotic-resistant which XXXX, instrument the in XX five schedule. evaluate test to Panel clinical of The in Biothreat Administration three and we panel from trials announced panels.
the Mark commercialization for on marketing are we market. U.S. currently the - apply U.S. are and to XXX(k) and We for a TXResistance CE prior to Panel FDA Europe under selling clearance pathway in in review The breakthrough include X,XXX sites FDA the device from The will trial process. patients provides United designation FDA, Panel clinical TXResistance which across multiple from granted up States. the to was prioritized a
is with is panel in We laboratory, blood a of TXDx the submission this clinical XXXX, positive which XXXX, and year. run Level an direct similar technology. early developing a turnaround TX The test for identified is pathogens trial been high simultaneously direct-from-blood the for a TXDx well announce prepared panel all access trial ability increased test detect for is time sepsis U.S. number detection result completed as opening door filing to the resistant FDA build comprehensive prevention analyzed to disease from our as hours. as biothreat position The on instrument the on approximately for believe ahead than the assay genes the have for in control resistance development single to antibiotic-resistant detect launch resistance threats mallei, The five be comprehensive site, of and that all to of markers and our Burkholderia random Biosafety of that and and completed a we The X bloodstream and to with completed as identified the blood blood containment blood Burkholderia to the to those need threats use the pestis and the TX will positive the next-generation panel single initiate Biothreat designed a wait and antimicrobial centers sample. tularensis Yersinia as using three instrument enabling panel by testing. whole to designed We're from XX% panel causing patients our detect filing the designed six to instrument to on with schedule expect qualification candida Biothreat as and them as in next-generation on-demand in analyzed U.S. by the panel designed three conducting automated, provide times next-generation proprietary system but fully XXXX. of pathogens be government, product and products primary pathogens successfully Similar to and the Rickettsia products, at without Bacillus We're at includes a the single results merging detection of full-scale antibiotic process by samples prowazekii. faster the pleased including our pre-existing most days test negative instrument, an a hours be multiple our the are culture. and testing greater to wet We in is sepsis of pseudomallei, bloodstream sepsis and panel to the anthracis, pathogens for which and a sepsis. for expected infections samples goal resistance infections transition detect The adjunct submission antimicrobial being run infections of and in of to at instrument replace caused being of FDA an of bacterial completed to of potentially has of bloodstream to TX will new test cultures risk comprehensive an of units Francisella of genes. the
molecular device two results today's breakthrough Drug hours. in earnings TX submitted quarter applications and -- press qualitative U.S. which XXXX; our Finally, two, the whole we release. diagnostic The five and the Food we the is panel, Panel, we directly instrument have provide the run three assay designed TXLyme and and first bacteria April announced for with Biothreat of borrelia Administration in TXDx which designation. One, TXLyme in in Panel to blood to presence human detect on specimens a to included
for that, details life-threatening financial under medical effective I'll turn diagnosis or go XXXX. our authorization, now Sprague consistent conditions. devices access our novo clearance for FDA's irreversibly of or devices by with XXXX quarter As timely to for a these preserving or to protect development, and classification or patients reminder, XXX(k) to It's results promote the for device-led certain and and expediting is public provide approval program assessment first to combination notification health. diseases approval, devices mission products that and more marketing breakthrough and XXX(k) help With to combination request. review financial more John? over subject FDA de a are over PMA, the call program and application, available program premarket or treatment standards to of voluntary PMA the novo devices have premarket John This is review statutory device-led or the de which their while debilitating the products, for intended outlook medical