Quotient Limited
Aug 7, 2017

Quotient Limited Reports Results From Ongoing MosaiQ Performance Evaluation Studies and First Quarter Fiscal 2018 Financial Results

JERSEY, Channel Islands, Aug. 07, 2017 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported progress on performance evaluation studies for MosaiQ™ and financial results for its fiscal first quarter ended June 30, 2017.

"We are continuing to make progress towards our goal of obtaining an initial CE mark for MosaiQ. The key step in this process, which we are providing an update on today, involves using market ready MosaiQ instruments as well as blood grouping and disease screening microarrays manufactured in our validated manufacturing facility to test for concordance with blood samples supplied and previously characterized by independent blood collection agencies. These results represent a major technical achievement for the project and give us added confidence of being field trial ready in the near future," said Paul Cowan, Chairman and Chief Executive Officer of Quotient. Mr. Cowan added, "The value that MosaiQ will deliver for our potential customers was underscored during our recent participation at ISBT's annual meeting held in Copenhagen this June. More than 230 ISBT delegates joined us at a symposium to discuss the benefits associated with routine comprehensive antigen typing for donated blood products, which MosaiQ will make possible on a routine basis once it is available in the market."

MosaiQ Platform

MosaiQ, Quotient's next-generation platform delivers fast, comprehensive antigen typing, antibody detection and disease screening results, using a single low volume sample in a high throughput automated format. MosaiQ represents a transformative and highly disruptive unified testing platform for transfusion diagnostics. Feasibility has also been demonstrated with respect to the detection of nucleic acids (DNA or RNA) using the MosaiQ platform. Through MosaiQ, Quotient expects to deliver substantial value to donor testing laboratories worldwide by providing affordable, routine comprehensive characterization and screening of blood products, on a single automated instrument platform designed to radically reduce labor costs and complexity associated with existing practice.

Assay Performance

Assay performance in the ongoing performance evaluation studies for the MosaiQ IH Microarray (the initial blood grouping microarray) and the MosaiQ SDS Microarray (the initial disease screening microarray) demonstrate substantial concordance compared with predicate technologies. The performance evaluation data were derived using microarrays manufactured in Quotient's validated, high-volume manufacturing facility and run on field trial-ready instruments.  The Company has taken the opportunity over the past two months to further improve the performance of the antibody detection assay, and that work is now complete. Final internal verification and validation studies for the MosaiQ IH Microarray and MosaiQ SDS Microarray are the next step in preparation for European field trials later this year. Verification and validation studies are designed to mimic the subsequent field trials.

MosaiQ IH Microarray - Antigen Typing

A summary of the most recent performance evaluation data derived in our ongoing study for antigen typing is set out below:

Blood Group AntigenABDCcEeCwKk
Concordance100%100%99.2%100%96.3%100%99.3%100%100%100%

In this study 268 donor samples were tested.

Actions to improve concordance for the c antigen are underway, including modification of the concentration of the detection reagent formulation for this specificity.

MosaiQ IH Microarray - Antibody Detection

The most recent performance evaluation study for the antibody detection assay achieved 97% concordance compared with the predicate technology.  In this study, 413 donor samples and 50 known positive samples were tested.

MosaiQ SDS Microarray

The most recent performance evaluation study for the MosaiQ SDS Microarray achieved 97% sensitivity and 100% specificity for CMV and 98% sensitivity and 100% specificity for syphilis.  In this study, 314 donor samples and 88 known positive samples were tested.  Known positive samples were selected to test the limits of detection for MosaiQ, hence the achieved sensitivity of 97-98% for both assays. These results indicate that the performance of the MosaiQ SDS Microarray meets or exceeds the established performance characteristics of the predicate technology.

The most recent performance evaluation data for the MosaiQ IH Microarray and MosaiQ SDS Microarray provide confidence in the ultimate outcome of the upcoming verification and validation studies for these products and ultimately the European field trials that we expect to complete later this year.

Regulatory and Commercial Milestones - Next Twelve Months

Fiscal First Quarter 2018 Financial Results

"The conventional reagent business recognized record product sales in the first quarter, while also having six new reagent products licensed for sale in the U.S. by the FDA," said Paul Cowan. "Strong top line performance was driven by 17% growth in sales to OEM customers, while U.S. direct sales which grew only 2%, were adversely impacted by the expected timing of shipments. Our continued focus on growing these more profitable revenue lines has shown positive results, with significant gross margin improvement in the quarter. Milestone payments earned from the approval for sale in the U.S. of certain rare antisera reagents developed for a key OEM customer contributed $600,000 of other revenues this quarter."

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

  Quarter Ended 
  June 30, 
  2017  2016 
Revenue:        
Product sales —OEM Customers $4,561  $3,911 
Product sales — direct customers and distributors  1,665   1,806 
Other revenues  600    
Total revenue $6,826  $5,717 
         
Product sales from standing orders (%)  79%  76%
         
Gross profit $3,994  $2,626 
Gross profit as a % of total revenue  58.5%  45.9%
Gross margin on product sales (%)  54.5%  45.9%
Operating (loss) $(16,906) $(16,378)

Capital expenditures totaled $5.4 million in 1QFY18, compared with $6.6 million in 1QFY17, largely reflecting ongoing investment related to the construction of our new conventional reagent manufacturing facility near Edinburgh, Scotland.

Quotient ended 1QFY18 with $40.7 million in cash and other short-term investments and $77.1 million of term debt, net of $5.0 million in an offsetting long-term cash reserve account. On April 10, 2017, the Company completed a public offering of its ordinary shares raising $45.2 million, net of expenses.

Outlook for the Fiscal Year Ending March 31, 2018

Product sales in the second quarter of fiscal 2018 are expected to be in the range of $5.2 to $5.5 million, compared with $4.8 million for the second quarter of fiscal 2017.

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.

Conference Call

Quotient will host a conference call on Tuesday, August 8th at 8:30 a.m. Eastern Time to discuss its first quarter fiscal 2018 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 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 August 30th by dialing 1-844-512-2921 in the U.S. or 1-412-317-6671 outside the U.S. The replay access code is 13667029.

About Quotient Limited

Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQTM technology platform to offer a breadth of tests that is unmatched by existing commercially available transfusion diagnostic instrument platforms. The Company's operations are based in Edinburgh, Scotland; Eysins, Switzerland and Newtown, Pennsylvania.

Forward-Looking Statements

This 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 MosaiQTM and other new products, current estimates of second quarter and full year fiscal 2018 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 proceeding; continued or worsening adverse conditions in the general domestic and global economic markets; 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 and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.

  
Quotient Limited 
Condensed Consolidated Statements Of Comprehensive Loss 
(in thousands, except share and per share amounts) 
(unaudited) 
  
  Quarter Ended 
  June 30, 
  2017  2016 
Revenue:        
Product sales $6,226  $5,717 
Other revenues  600    
Total revenue  6,826   5,717 
Cost of revenue  2,832   3,091 
Gross profit  3,994   2,626 
Operating expenses:        
Sales and marketing  1,682   1,257 
Research and development, net  12,673   11,801 
General and administrative expense  6,545   5,946 
Total operating expense  20,900   19,004 
Operating loss  (16,906)  (16,378)
Other income (expense)        
Interest expense, net  (4,210)  (1,171)
Other, net  880   1,314 
Other income (expense), net  (3,330)  143 
Loss before income taxes  (20,236)  (16,235)
Provision for income taxes      
Net loss $(20,236) $(16,235)
Other comprehensive income (loss):        
Change in fair value of effective portion of
  foreign currency cash flow hedges
 $345  $(263)
Unrealized gain on short-term investments  38    
Foreign currency gain (loss)  1,815   (3,308)
Provision for pension benefit obligation  43   41 
Other comprehensive income (loss)  2,241   (3,530)
Comprehensive loss $(17,995) $(19,765)
Net loss available to ordinary shareholders
  - basic and diluted
 $(20,236) $(16,235)
Loss per share - basic and diluted $(0.55) $(0.64)
Weighted-average shares outstanding - basic and
  diluted
  36,767,544   25,410,598 


  
Quotient Limited 
Condensed Consolidated Balance Sheets 
(In Thousands) 
(Unaudited) 
  
  June 30,
2017
  March 31,
2017
 
ASSETS        
Current assets:        
Cash and cash equivalents $13,008  $4,754 
Short-term investments  27,661   16,057 
Trade accounts receivable, net  2,800   2,556 
Inventories  14,810   13,636 
Prepaid expenses and other current assets  4,682   3,629 
Total current assets  62,961   40,632 
Cash reserve account  5,040   5,040 
Property and equipment, net  70,062   63,530 
Intangible assets, net  784   769 
Total assets $138,847  $109,971 
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)        
Current liabilities:        
Accounts payable $10,098  $10,782 
Accrued compensation and benefits  2,846   3,641 
Accrued expenses and other current liabilities  13,398   13,509 
Current portion of lease incentive  441   422 
Capital lease obligation  1,445   1,374 
Total current liabilities  28,228   29,728 
Long-term debt  82,150   80,704 
Lease incentive, less current portion  772   844 
Capital lease obligation, less current portion  153   174 
Defined benefit pension plan obligation  5,535   5,337 
7% Cumulative redeemable preference shares  17,538   17,275 
Total liabilities  134,376   134,062 
Total shareholders' equity (deficit)  4,471   (24,091)
Total liabilities and shareholders' equity (deficit) $138,847  $109,971 


  
Quotient Limited 
Condensed Consolidated Statements of Cash Flows 
(In Thousands) 
(Unaudited) 
  
  Quarter ended
June 30,
 
  2017  2016 
OPERATING ACTIVITIES:        
Net loss $(20,236) $(16,235)
Adjustments to reconcile net loss to net cash provided by operating activities:        
Depreciation and amortization  2,464   2,286 
Share-based compensation  1,285   898 
Amortization of lease incentive  (109)  (109)
Swiss pension obligation  172   185 
Amortization of deferred debt issue costs  1,446   228 
Accrued preference share dividends  263   263 
Net change in assets and liabilities:        
Trade accounts receivable, net  (170)  (204)
Inventories  (608)  (560)
Accounts payable and accrued liabilities  (2,005)  1,406 
Accrued compensation and benefits  (837)  (152)
Other assets  (811)  (1,247)
Net cash used in operating activities  (19,146)  (13,241)
INVESTING ACTIVITIES:        
Increase in short-term investments  (43,000)   
Realization of short-term investments  31,434    
Purchase of property and equipment  (5,436)  (6,579)
Purchase of intangible assets  (6)   
Net cash used in investing activities  (17,008)  (6,579)
FINANCING ACTIVITIES:        
Repayment of finance leases  (29)  (37)
Proceeds from issuance of ordinary shares  45,273    
Net cash generated from financing activities  45,244   (37)
Effect of exchange rate fluctuations on cash and cash equivalents  (836)  (1,860)
Change in cash and cash equivalents  8,254   (21,717)
Beginning cash and cash equivalents  4,754   44,100 
Ending cash and cash equivalents $13,008  $22,383 
Supplemental cash flow disclosures:        
Income taxes paid $  $ 
Interest paid $5,068  $679 


CONTACT: Chris Lindop, Chief Financial Officer — chris.lindop@quotientbd.com; +41 22 545 52 26