Developed a high performance COVID-19 Antibody Test
Several customer contracts signed for MosaiQ system and COVID-19 Antibody TestTransfusion Dx Expanded Immunohematology (IH) Field Trials have restarted following COVID related delaysInitial Serological Disease Screening (SDS) CE Mark obtainedContinued Strong Top Line Growth in Fourth Quarter and Full Year JERSEY, Channel Islands, June 09, 2020 (GLOBE NEWSWIRE) — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (Quotient or the Company), headquartered in Eysins, Switzerland, today summarized recent key achievements. These included Quotient’s rapid development of a high performance COVID-19 antibody test based on its innovative MosaiQ™ platform and several commercial MosaiQ contracts. Quotient’s European Field Trials in transfusion diagnostics recently restarted for the Company’s expanded MosaiQ IH microarray. A CE Mark was obtained for the Company’s initial SDS microarray. The Company also announced strong top line growth for both its fourth quarter ended March 31, 2020 and for the full financial year.“The global coronavirus crisis was a shock to everyone, but we are very proud of how the Quotient team leveraged the knowledge we acquired over the past eight years, and the flexibility of the MosaiQ platform, to develop a state of the art COVID-19 antibody test. The test performs with 100% sensitivity and 99.8% specificity and detects antibodies early due to its sensitivity to both IgM and IgG antibodies. The fact that we were able to sign several MosaiQ COVID-19 antibody test customer contracts, demonstrates the attractiveness of our innovative MosaiQ platform,” said Franz Walt, Chief Executive Officer of Quotient.Mr. Walt added “I am pleased to report that we restarted the expanded IH Field Trials in Europe and we are expecting the first commercial transfusion menu in Q1 CY2021. I am also pleased that, despite the unprecedented disruption caused by the pandemic, we were able to exceed sales expectations for our Alba by Quotient reagent business.”MosaiQ PlatformMosaiQ, Quotient’s next-generation platform, is designed to deliver fast immunohematology, serological and molecular disease screening (MDS), using a single low volume sample on a high throughput automated platform. MosaiQ represents a transformative and highly disruptive unified testing system for transfusion diagnostics and beyond. Feasibility to deliver required performance in serological and molecular disease screening has been demonstrated. MosaiQ offers the potential to significantly reduce complexity and improve workflow for our customers.Regulatory and Commercial MilestonesNew Product Development – The rapid development of the Company’s MosaiQ COVID-19 antibody test is a notable success. It also represents an interesting opportunity because the test is primarily commercialized outside of donor labs and therefore outside Quotient’s initial target market. It introduces the MosaiQ platform to a different market. The first customer contract was signed shortly after the CE marking and the Company subsequently entered into several more contracts with customers in Europe and the United States.European Regulatory Approval – The CE mark for the initial MosaiQ IH microarray was obtained in April 2019 and for the initial SDS microarray in February 2020. The COVID-19 antibody test was CE marked on May 1, 2020 and is the fifth CE mark for the MosaiQ platformUS Regulatory approval – Quotient submitted a 510(K) for the initial SDS microarray and the MosaiQ device in December 2019. The request for FDA Emergency Use Authorization of the COVID-19 antibody test was submitted on May 6, 2020Field Trials – Expanded IH field trials in Europe restarted recently after they were interrupted in March due to the coronavirus pandemicOngoing Microarray Menu Development – Two benchmark studies were successfully completed for selected SDS and MDS parameters demonstrating the high performance of the MosaiQ technologyUpcoming Regulatory Submissions– Submission of the expanded IH microarray in Europe is expected in Q4 of CY2020 followed by US submission in the first half of CY2021. The European submission of the expanded SDS microarray is expected in the second half of CY2021Franz Walt commented “I am delighted with the Quotient team who were able to turn the crisis into a positive contribution to the fight against COVID-19 and who continue to deliver on our goals.”Fiscal Fourth Quarter and Full Year Financial ResultsThe Alba by Quotient reagent business once again generated strong revenue growth during fiscal 2020, with product revenues growing 10.2% for the full year and 11.1% in the fourth quarter. Product revenue growth for the fiscal year was driven by 5% growth in sales to original equipment manufacturer (OEM) customers, while direct product sales grew 24%. In the fourth quarter, gross margin on product sales was 45.6% compared to 43.5% in the fourth quarter of fiscal 2019, reflecting improved product mix and the efficiencies gained through the Company’s new reagent manufacturing site. For fiscal year 2020 gross margin on product sales also improved year on year from 39.9% to 43.7%, as the incremental costs of the relocation to the new manufacturing site were removed. Milestone payments earned from the development and approval for sale in the United States of certain rare antisera reagents developed for a key OEM customer, contributed $1.1 million of other revenues in fiscal year 2020 compared to $0.5 million in the prior year.Key revenue and profit results are summarized below (expressed in thousands, except percentages)The operating loss for the quarter and the year ended March 31, 2020 included termination and transition benefit costs of approximately $0.9 million and $2.1 million, respectively, as well as, legal and advisory fees related to the Company’s termination of its distribution and supply agreement with Ortho Clinical Diagnostics Inc. (OCD) and the related arbitration with OCD. Capital expenditures totaled $4.6 million in the year ended March 31, 2020, compared with $4.8 million in the year ended March 31, 2019.As at March 31, 2020 Quotient had $120.8 million in available cash and other short-term investments and $153.0 million of debt and $8.7 million in an offsetting long-term cash reserve account.Outlook for the Fiscal Year Ending March 31, 2021Total product sales of Alba by Quotient reagents in the range of $32 to $34 million compared to product sales in fiscal 2019 of $31.6 million. A forecast of COVID-19 antibody tests is not currently possible due to the uncertainties related to the development of this new market. No other revenues are expected.Capital expenditures in the range of $5 to $10 million.Average monthly cash use for operations in the range of $5 to $6 million excluding potential revenue related to COVID-19 antibody test.Alba by Quotient product sales in the first quarter of fiscal 2021 are expected to be within the range of $8.4 to $8.9 million, compared with $8.2 million for the first quarter of fiscal 2020.The Company is not providing guidance on the operating loss due to the uncertainty around revenues derived from MosaiQ by Quotient COVID-19 antibody tests.Quarterly product sales can fluctuate depending upon the shipment cycles for red blood cell-based products, which account for approximately two-thirds of current product sales. These products typically experience 13 shipment cycles per year, equating to three shipments of each product per quarter, except for one quarter per year when four shipments occur. The timing of shipment of bulk antisera products to OEM customers may also move revenues from quarter to quarter. Some seasonality in demand is also experienced around holiday periods in both Europe and the United States. As a result of these factors, Quotient expects to continue to see seasonality and quarter-to-quarter variations in product sales. The timing of product development fees included in other revenues is mostly dependent upon the achievement of pre-negotiated project milestones.The accompanying condensed consolidated financial statements have been prepared on a basis which assumes that Quotient will continue as a going concern. However, the Company has incurred net losses from operations in each year since it commenced operations in 2007 and had an accumulated deficit of $483.4 million as of March 31, 2020. The Company expects to include disclosure within its Annual Form 10-K in respect of certain conditions concerning the Company’s overall liquidity position that raise substantial doubt about its ability to continue as a going concern, which the Company’s auditors will also reference in their report on the Company’s consolidated financial statements.Conference CallQuotient will host a conference call on Tuesday, June 9 at 8:00 a.m. Eastern Time to discuss its fourth quarter fiscal 2020 financial results. Participants may access the call by dialing 1-877-407-0784 in the U.S. or 1-201-689-8560 outside the U.S. The access code is 13704376. The conference call will be webcast live on the Company’s website at www.quotientbd.com.A replay of this conference call will be available through June 16, 2020 by dialing 1-844-512-2921 in the U.S. or 1-412-317-6671 outside the U.S. The replay access code is 13704376.About Quotient LimitedBuilding on over 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. MosaiQ, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ is designed to be a game-changing solution, which Quotient believes will increase efficiencies, improve clinical practice, deliver significant workflow improvements, and create operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania.Forward-Looking StatementsThis news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include statements regarding our expectations of continued growth, the development, regulatory approval, commercialization and impact of MosaiQ and other new products (including the potential for using the Company’s MosaiQ technology to infectious disease diagnostics), current estimates of first quarter and full year fiscal 2021 operating results and expectations regarding our future funding sources. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include delays or denials of regulatory approvals or clearances for products or applications; market acceptance of our products; the impact of competition; the impact of facility expansions and expanded product development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or field trial studies; adverse results in connection with any ongoing or future legal proceedings, including the ongoing arbitration with OCD; continued or worsening adverse conditions in the general domestic and global economic markets, including as a result of the global COVID-19 pandemic; as well as the other risks set forth in the Company’s filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements.The Quotient logo, Quotient MosaiQ and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.CONTACT: Peter Buhler, Chief Financial Officer – [email protected]; +41 22 545 52 26





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