Quotient Limited Reports Fourth Quarter And Full-Year Financial Results For The Year Ended March 31, 2015

JERSEY, Channel Islands, May 18, 2015 (GLOBE NEWSWIRE) -- Quotient Limited (Nasdaq:QTNT), a commercial-stage diagnostics company, today reported financial results for its fourth quarter and fiscal year ended March 31, 2015.

"During the quarter we continued to make excellent progress on bringing MosaiQ™ to market," said Paul Cowan, Chairman and Chief Executive Officer of Quotient. "Installation of the MosaiQ™ consumable manufacturing system at our Eysins, Switzerland facility is set to commence next month and we expect to receive the first instruments for field trials towards the end of 2015. The latest performance evaluation data for assays to be incorporated on both the blood grouping and disease screening consumable continued to be very positive and we remain on track for the commercial launch of MosaiQ™ in Europe during the second half of 2016."

MosaiQ™ Status Update

MosaiQ™, our next-generation automation platform for blood grouping and serological disease screening, is at an advanced stage of development with our efforts now focused on industrial scale-up for final product validation and commercialization.

Conversion of our Eysins, Switzerland facility is substantially complete and next month we will start installing the key elements of the initial manufacturing system for MosaiQ™ consumables. We expect to complete formal validation of the initial manufacturing system before the end of 2015.

We expect to begin transferring to production individual assays for the blood grouping consumable in the second quarter of 2015 with completion expected before the end of 2015. We also expect to transfer to production the CMV and Syphilis assays for the initial disease screening consumable in the fourth quarter of 2015, with remaining planned disease screening assays (HBV, HCV, HIV, HTLV and Chagas) for inclusion on the full disease screening consumable expected to be transferred to production in the first half of 2016.

Development of the MosaiQ™ instrument is also at an advanced stage. We have received advanced prototype instruments from STRATEC for evaluation, which have met our expected functional requirements. We expect to use these prototype instruments to undertake a further large-scale validation study in the middle of 2015, prior to receiving field trial versions of the MosaiQ™ instrument before the end of 2015.

We plan to commence formal field trials in the first half of 2016 and file necessary regulatory submissions in the second half of 2016, first in Europe and then in the United States, to obtain required marketing clearances. If licensed for sale, we continue to anticipate commercial launch for both the MosaiQ™ blood grouping consumable and the initial MosaiQ™ disease screening consumable in Europe during the second half of 2016 and in the United States during the second half of 2017. We anticipate commercial launch of the full MosaiQ™ disease screening consumable in Europe during the second half of 2017 and in the United States during 2018, quicker than previously anticipated.

OCD Commercial Partnership

In January 2015, we announced that we had entered into a distribution and supply agreement with Ortho-Clinical Diagnostics, or OCD, to sell and distribute MosaiQ™ within the $2.8 billion global transfusion diagnostics market (the "OCD Agreement"). OCD is recognized as the global market leader in the supply of transfusion diagnostics. Pursuant to this agreement, OCD will exclusively commercialize MosaiQ™ for the global patient testing market (for blood grouping), as well as the donor testing market (for blood grouping and serological disease screening) for territories other than those (North America, Europe and certain territories in the Asia-Pacific region, excluding Japan) in which we will commercialize MosaiQ™. We will remain responsible for the manufacture and supply of all MosaiQ™ related products and have retained all other commercial rights to MosaiQ™.

Pursuant to the OCD Agreement, we received $25 million of funding, in the form of an investment in our ordinary shares and preference shares and OCD agreed to pay us certain one-time payments upon the achievement of regulatory and commercial milestones totaling in the aggregate $59 million. These milestones primarily relate to the approval and launch of MosaiQ™ in the United States and Europe for blood grouping. OCD has also agreed to reimburse us for the cost of goods sold incurred for MosaiQ™ instruments and associated replacement parts sold to OCD, as well as the cost of ancillary products sold to OCD. A transfer price mechanism for MosaiQ™ consumables sold to OCD has also been established, which will increase as a percentage of net sales based on the achievement of agreed-upon revenue milestones. In addition, a basis for calculating minimum transfer prices for MosaiQ™ consumables, instruments and ancillary products has also been agreed.

Conventional Reagent Business Update

"Our conventional reagent business continued to progress to plan during fiscal 2015, despite the negative impact on reported revenues of a stronger than forecast U.S. dollar during the last two quarters of the year," said Paul Cowan. While this had only a limited impact on our reported operating profit, revenue growth over the next twelve months will likely be impacted by the recent appreciation of the U.S. dollar against the Euro and British Pound. Conventional reagent revenue growth will also be impacted by a shift in production to support the commercial scale-up of MosaiQ™ in fiscal 2016."

"Product sales in FY15 grew 4% year-over-year to $17.7 million, or 6% excluding the negative impact of foreign currency translation. Ongoing product rationalization continues to release production capacity for higher margin product sales with greater growth potential and assay development support for MosaiQ™. Since the beginning of fiscal 2015, we have launched six new conventional reagent products in the U.S. market. These new product launches are expected to drive continued growth for our conventional reagent business."

Key revenue and profit results are summarized below (expressed in thousands):