Quotient Limited

Greetings, and welcome to the Quotient Limited First Quarter Fiscal Year 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the call, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I'd now like to turn the conference over to your host, Mr. Ali Khaboura, Chief Financial Officer of Quotient Limited. Please go ahead, sir.

Thank you. Good morning, everybody, and welcome to Quotient's first quarter fiscal year 2023 financial results, as well as the business update. Joining me today is Manuel O. Mendez, our Chief Executive Officer. Today's conference call, broadcast live through an audio webcast and a replay of the conference call, will be available later today at www.quotientbd.com. During this call, Quotient will be making forward-looking statements, including guidance and projections as to future operating results and expected development and commercialization timelines. Because such statements deal with future events, actual results may differ materially from those projected in the forward-looking statements. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements can be found in quotients filings for the U.S. Securities and Exchange Commission as well as in this morning's release. The forward-looking statements, including guidance and projections provided during this call, are valid only as of today's date, August 9th, 2022, and quotient assumes no obligation to publicly update these forward-looking statements. With that, I would like to turn the call over to quotient's chief executive officer, Manuel O. Mendez.

Thanks, Ali, and good morning, everyone. Thank you for joining us today for the first quarter fiscal 2023 results and business update. During today's call, I will provide an update on the progress we have made in the month since we had our last earnings call and our key priorities to fiscal 2023. As many of you will know, earlier this year, we received CE mark for our extended immunohematology microarray. Since then, we have made progress on maximizing the commercial potential for this product by growing our distribution network, participating in tenders, and increasing awareness of the Mosaic solution. We are simultaneously focused on leveraging the potential of our Mosaic platform with new microarrays. The ones closest to commercialization are extended serological disease screening microarray, autoimmune microarray, and the extended immunohematology US microarray. I am pleased to report we remain on track with our development work and regulatory filings for all three microarrays. Also, we have been exploring ways to lower R&D costs to bring new products to market and decrease the time to commercialization. Pursuant to this initiative, we recently announced new strategic alliances with Infinity Biomarkers and Theradiag. We believe these alliances will enhance our development of infectious disease screening and clinical diagnostic products. In addition, we have made advancements in our scientific and medical affairs activities with the expansion of our innovator circle, completion of workflow studies, and development of white papers. Overall, I am pleased with the execution of our key priorities since our last call just over a month ago, and I look forward to our continued progress in fiscal 2023. Let's begin with a review of Mosaic's commercial execution. In the first quarter of fiscal 2023, We secured $1.4 million in bookings and generated $0.4 million in revenue for our recently CE marked extended immunohematology mosaic solution. The commercial team continues to focus on expanding our global distribution footprint across major geographies. We have signed 10 distributor agreements, and last month we hosted our first annual distributor network meeting. The meeting was held at our headquarters in Switzerland with 12 participants from over 10 different countries who shared best practices and clinical use cases for Mosaic. Participants were enthusiastic. One of the participants, Teresa Marsik from Croatia, told us she is impressed with the Mosaic system's ease of use and she is excited for her customers to experience the Mosaic solution. I'd like to thank Teresa and all other participants. We look forward to our continued collaboration. Turning to our European immunohematology donor tender opportunities, we continue to actively participate in and prepare for the 20 European immunohematology tenders expected over the next 18 months. Turning to our transfusion diagnostics pipeline, the extended immunohematology US microarray is on track for FDA submission by year end. We continue to make progress in the development of the extended serological disease screening microarray panel. We're on track for an expected commercial launch in calendar year 2023. Our recently announced partnership with Infinity Biomarkers serves as an opportunity to enrich the Mosaic STS and infectious disease clinical immunoassay menu and reduce time and cost to commercialization. Infinity Biomarkers has proven expertise in infectious disease diagnostics and we are excited about this collaboration as it expands our innovation network, allowing us to further accelerate our development timeline. We're also pleased with the early benefits we are seeing from the TheraDiag Clinical Diagnostics Partnership. The collaboration team has confirmed technical feasibility of the extractable nuclear antigen antibodies, ENA, on the mosaic microarray. We are confident to make continued progress in our development eventual commercialization of the Connected Tissue Diseases Panel, which will include the ENA and anti-nuclear antibodies, ANA. This panel will provide us with access to part of the $1.8 billion autoimmune market and entry into the clinical diagnostic segment. Like the Infinity Collaboration, this partnership allows us to accelerate our time to commercialization and reduce cost of development. Next, I would like to update you on the scientific and medical affairs activities. We are very pleased to add three members during the quarter on the Mosaic Innovative Circle Initiative. We now have a total of 11 members, most recently the Centro de Hemoterapia y Hemodonación de Castilla y León in Spain joined this initiative. As a reminder, the goal of the Innovative Circle is to create a community of experts and institutions across the world who focus on transfusion medicine and clinical diagnostics. Member partners with Quotient to create innovation and evidence generation to improve patient care and laboratory efficiencies. Lastly, we are pleased to announce we have completed flow analysis at multiple sites. These analyses include current and future time and motion studies, which we expect will underline the efficiency and effectiveness of the Mosaic solution. We expect to submit papers for publication later this year. We are continuing to build an experienced and collaborative executive management team. Steven Suderwick joined quotient on July 1st in the role of Chief Strategy and Business Development Officer. Prior to joining our company, Stephen served as vice president of Philips, leading global strategy and business development and execution in the precision diagnostic business. Prior to Philips, Stephen led teams across Europe, Middle East, and Boston Consulting Group, BCG, to develop corporate and commercial strategies for leading financial institutions and executed several post-merger integrations and turnarounds. Stephen brings great experience and energy to help our team drive business growth, portfolio expansion, market access, and broaden global strategic partnerships. Welcome, Stephen. Finally, on the operations front, we were awarded ISO 14001 certification, reflecting we meet requirements for environmental management system. This certification exists to help organizations minimize how operations negatively affect the environment. To qualify, Quotient went through a series of external audits validating the Mosaic microarray manufacturing facility. Now let me turn the call to Ali for more details on our financial results. Ali?