Quotient Limited

Greetings. Welcome to Quotient Limited's fourth quarter and full year fiscal year 2022 financial results conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from 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 Kabaro, Chief Financial Officer of Quotient Limited. Please go ahead.

Thank you, Rob. Good morning, everyone, and welcome to Quotient's fourth quarter and full year 2022 financial results, as well as business update. Joining me today is Manuel Mendez, our Chief Executive Officer. Today's conference call is being 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 quotient filings with the U.S. Securities and Exchange Commission, as well as in this morning's relief. The forward-looking statements, including guidance and projections provided during this call, are valid only as of today's date, June 24, 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 CEO, Manuel Mendez.

Thanks, Ali, and good morning, everyone. Thank you for joining us today for the fourth quarter fiscal 2022 results and business update. During today's call, my comments will cover our strategic financing transaction we recently announced, the exciting progress we have made around Mosaic menu expansion and the distribution footprint, and our pipeline activities in clinical diagnostics. Then, Ali will review our financial results and outlook for fiscal year 2023, followed by my summary comments before we open it up for a Q&A session. Today, we announced two actions to improve our liquidity runway, and provide greater financial flexibility in our balance sheet. First, we amended our senior secured notes, reducing our amortization payments by a net $93 million over the next 36 months. Second, we raised $20 million in gross proceeds through an equity deal. The proceeds from the deal will fund our major growth initiatives, which I will cover next. Let me now provide you with a quick update on our commercial execution. Following the extended immunohematology commercial launch, our efforts this quarter have secured 1.4 million of Mosaic orders in the first quarter of fiscal year 2023. We are focused on expanding our distribution footprint across the major international geographies. The commercial team has made significant progress this quarter and have signed nine international agreements with distributors. Overall, I am very pleased with the momentum we have generated in expanding our commercial distribution footprint and our pipeline opportunities to grow. In conjunction with the geographical expansion activities, we're highly focused on the large volume of immunohematology tenders we are tracking in Europe and other eligible CE mark territories. We anticipate these tenders will come into play within the next 18 months. This is an important part of our strategy to drive increased awareness and market share gains with existing and potential customers who may be attracted by the Mosaic solution economic and clinical value. We look forward to updating you on our progress on the tender opportunities throughout the year. Turning to our Mosaic solution for the transfusion diagnostics channel, this past March we were thrilled to receive CE mark of the Mosaic extended immunohematology microarray. The receipt of the CE mark was a significant company milestone as it enabled Quotient to commercialize the immunohematology microarray for use with our Mosaic instrument across the European Union and other CE mark-recognizing geographies. As a reminder for our listeners who are newer to our story, Mosaic offers our transfusion and clinical lab customers an all-in-one, fully automated, high-performance, multimodal, multiplexing solution. More specifically, the immunohematology microarray allows the user to perform extended phenotyping, antibody screening, antigen typing, including ABO forward and reverse groupings. Laboratories and clinicians may use the solution to generate comprehensive characterization of blood donor samples through a single test procedure. Our strategy is to continue to expand the Mosaic menu to drive increased value for our customers and economies of scale for our business. We have been working with the FDA in the U.S. during our pre-submission meetings as we're making important advancements in the extended immunohematology trials. Our progress includes performance and manufacturability advances and exciting development work which yielded an expansion of the specificities in this product. Next, I want to share the progress we continue to make on our serological disease screening microassay. Throughout our clinical development work, we are advancing the sensitivity of our lead infectious disease immunoassay multiplex panel. The company continues to be on track to submit an application to the EU for CE microapproval in the second half of calendar year 2022. Next, I'd like to provide an update on our clinical diagnostics. We are very pleased about the clinical diagnostic activity this past quarter, namely our partnership announcement with Theradiag. Our two companies bring together complementary solutions to jointly develop autoimmune mosaic microarray reagents and multiconstituent quality controls. First, with a collective solution for collective tissue diseases, connective tissue diseases, or CTD. Testing involves a complex diagnostic pathway, in order to identify the exact autoimmune disease and to distinguish from other conditions with similar clinical signs and symptoms. The integration of several autoantibody diseases and tests into a single multiplex assay is thought to simplify testing and ultimately provide a faster and more reliable path to patients and clinicians to diagnosis and adequate therapy. Autoimmune diagnostics provides an additional estimated $2 billion addressable market opportunity for Quotient's Mosaic platform. An autoimmune microarray would have a faster path to market at a lower cost when compared to blood diagnostics due to different regulatory requirements. Now on to our scientific and medical activities. We held our first KOL event this past quarter with Dr. Christophe Martineau, where he shared his expert insight on the current landscape and unmet needs within blood grouping and donor's disease screening. During the session, he stated, Mosaic is easy to use and is a game-changing system in diagnostics as it has direct impact on patient safety through extended phenotyping. We look forward to organizing more KOL sessions into the year. Additionally, we are very pleased with the development of a Mosaic Innovator Circle initiative, which we first launched in March. The goal of the Innovative Circle is to create a community of experts from laboratories across the world who focus on transfusion medicine and clinical diagnostics. Our member partners with Quotient to create innovation and evidence generation to improve patient care and laboratory efficiencies. We're up to eight members with a goal of expanding our network of experts in the next few months. We signed an international partnership with Centre Pasteur in Cameroon as part of our investigator initiative research program. The partnership will provide Quotient's R&D team access to rare HIV samples and will also sponsor young scientists studying infectious diseases. This program is open to all healthcare professionals who wish to study the clinical and economic impact of the Mosaic system. Currently, two Mosaic workflow efficiency studies are in progress, one in Europe and one in the U.S., and we look forward to giving you the results in the near future. I would like to conclude this section with two recent wins. I am pleased to announce that our headquarters, and particularly our microarray manufacturing facility in Essen, Switzerland, passed the ISO 14001 certification, which sets out the requirements for an 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 and is now officially ISO 14001. 14001 certification. Thank you Esteban Uriarte, our Chief Manufacturing Operations Officer, and his team for leading this important project. Lastly, I'm pleased to announce that as of today, we have shipped multiple Mosaic instruments to customers. This is an exciting time of quotient, and I'm very proud of Mohamed Elkhoury, our Chief Commercial Officer, and the commercial team for making excellent progress and delivering a major commercial win for the whole company. It was certainly a team effort across the board. Well done, everyone. Now, let me turn the call to Ali for more details on our financial results. Ali.