- FDA Emergency Use Authorization for the MosaiQ COVID-19 antibody test received
- FDA 510(k) clearance for Initial MosaiQ SDS microarray and MosaiQ instrument expected before the end of CY2020
- European field trial for Expanded MosaiQ IH microarray progressing; on track for CE Mark submission in Q4 2020
- Binding Letter Agreement for patient transfusion diagnostics signed with
Ortho Clinical Diagnostics ; eligible for up to$67.5 million in milestones and arbitration settled - Double digit growth for Alba by Quotient reagents, reaching high-end of guidance
- Strong cash position following successful completion of public equity offering
JERSEY, Channel Islands,
Quotient obtained an FDA Emergency Use Authorization (EUA) in
The European field trials for the MosaiQ Expanded Immunohematology (IH) microarray are progressing and a submission for CE Mark is planned for the fourth quarter of calendar year (CY) 2020. The Expanded IH microarray is expected to be available for sale in
At the beginning of
The Company also announced double digit growth for Alba by Quotient reagents for the second quarter ended
Following an equity capital raise in
MosaiQ Platform
MosaiQ, Quotient's next-generation platform, is designed to deliver fast immunohematology, serological and molecular disease screening, using a single low volume sample on a high throughput, multimodal multiplexing 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. A serological test was developed in
Regulatory and Commercial Milestones
- Donor IH Field Trials – Results of the Expanded IH microarray field trials in
Europe are expected inNovember 2020 . The submission for CE mark is targeted before year-end while the CE mark is anticipated to be obtained by the end of the first quarter of CY2021 - SDS Field Trials – European field trials for the Expanded SDS microarray are targeted to start in the first half of CY2021 with a CE mark submission targeted in the second or third quarter of CY2021
- Commercial Offering – The first comprehensive commercial combination for the donor transfusion market (Initial SDS and Expanded IH microarrays) is expected to be available in
Europe at the end of the first quarter of CY2021 - Patient IH – The Company is developing for Ortho an IH microarray for the patient transfusion market and we expect to submit for CE mark in the fourth quarter of CY2021
- Donor IH Field Trials – Expanded IH field trials are expected to commence by
December 2020 or at the beginning of CY2021. - SDS Regulatory –
US FDA 510(k) clearance for the Initial SDS microarray and the MosaiQ instrument is expected before the end of CY2020
Quotient CEO
Fiscal Fourth Quarter and Full Year Financial Results
The Alba by Quotient reagent business continues to deliver top line growth, with strong product sales of
Other revenues for the quarter ended
In the quarter ended
Key revenue and profit results are summarized below (expressed in thousands, except percentages).
| Quarter Ended | Six Months Ended | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product sales —OEM customers | $ | 5,034 | $ | 4,696 | $ | 11,218 | $ | 10,431 | ||||||||
| Product sales — direct customers and distributors | 2,942 | 2,400 | 5,571 | 4,834 | ||||||||||||
| Product sales – MosaiQ | 567 | — | 678 | — | ||||||||||||
| Other revenues | 7,523 | 750 | 7,523 | 750 | ||||||||||||
| Total revenue | $ | 16,066 | $ | 7,846 | $ | 24,990 | $ | 16,015 | ||||||||
| Product sales from standing orders (%) | 67 | % | 68 | % | 68 | % | 70 | % | ||||||||
| Gross profit | $ | 11,567 | $ | 3,876 | $ | 15,077 | $ | 7,481 | ||||||||
| Gross profit as a % of total revenue | 72.0 | % | 49.4 | % | 60.3 | % | 46.7 | % | ||||||||
| Gross margin on product sales (%) | 47.3 | % | 44.1 | % | 43.2 | % | 44.1 | % | ||||||||
| Operating (loss) | $ | (13,098 | ) | $ | (18,441 | ) | $ | (32,819 | ) | $ | (36,864 | ) | ||||
The operating loss for the quarter ended
Capital expenditures totaled
On
As at
Outlook for the Fiscal Year Ending
- Total product sales of Alba by Quotient reagents are still expected to be in the range of
$32 to$34 million compared to product sales in fiscal 2020 of$31.6 million . - 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 third quarter of fiscal 2021 are expected to be within the range of
Quotient is unable to reliably forecast sales volumes for its MosaiQ COVID-19 antibody tests because the market for those tests is still developing and industry expectations as to potential demand vary widely. For this reason, Quotient also is not providing guidance on its operating results for the remainder of this fiscal year.
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
Conference Call
Quotient will host a conference call on
A replay of this conference call will be available through
About
Building 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,
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 MosaiQ and other new products (including the potential for using the Company’s MosaiQ technology to infectious disease diagnostics), current estimates of third 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 future legal proceedings, 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
The Quotient logo, Quotient MosaiQ and MosaiQ™ are registered trademarks or trademarks of
CONTACT:
Condensed Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share amounts)
(Unaudited)
| Quarter Ended | Six Months Ended | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product sales | $ | 8,543 | $ | 7,096 | $ | 17,467 | $ | 15,265 | ||||||||
| Other revenues | 7,523 | 750 | 7,523 | 750 | ||||||||||||
| Total revenue | 16,066 | 7,846 | 24,990 | 16,015 | ||||||||||||
| Cost of revenue | 4,499 | 3,970 | 9,913 | 8,534 | ||||||||||||
| Gross profit | 11,567 | 3,876 | 15,077 | 7,481 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales and marketing | 2,231 | 2,253 | 4,474 | 4,833 | ||||||||||||
| Research and development, net | 12,878 | 13,083 | 24,328 | 24,736 | ||||||||||||
| General and administrative expense | 9,556 | 6,981 | 19,094 | 14,776 | ||||||||||||
| Total operating expense | 24,665 | 22,317 | 47,896 | 44,345 | ||||||||||||
| Operating loss | (13,098 | ) | (18,441 | ) | (32,819 | ) | (36,864 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest expense, net | (6,858 | ) | (7,291 | ) | (12,784 | ) | (13,376 | ) | ||||||||
| Other, net | 4,998 | (1,244 | ) | 5,231 | (294 | ) | ||||||||||
| Other expense, net | (1,860 | ) | (8,535 | ) | (7,553 | ) | (13,670 | ) | ||||||||
| Loss before income taxes | (14,958 | ) | (26,976 | ) | (40,372 | ) | (50,534 | ) | ||||||||
| Provision for income taxes | (17 | ) | (14 | ) | (32 | ) | (27 | ) | ||||||||
| Net loss | $ | (14,975 | ) | $ | (26,990 | ) | $ | (40,404 | ) | $ | (50,561 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Change in fair value of effective portion of foreign currency cash flow hedges |
$ | 279 | $ | (158 | ) | $ | 276 | $ | (278 | ) | ||||||
| Change in unrealized gain on short-term investments | (79 | ) | 47 | (483 | ) | 194 | ||||||||||
| Foreign currency gain (loss) | (3,447 | ) | (11 | ) | (3,301 | ) | (1,025 | ) | ||||||||
| Provision for pension benefit obligation | 14 | 48 | 27 | 96 | ||||||||||||
| Other comprehensive loss | (3,233 | ) | (74 | ) | (3,481 | ) | (1,013 | ) | ||||||||
| Comprehensive loss | $ | (18,208 | ) | $ | (27,064 | ) | $ | (43,885 | ) | $ | (51,574 | ) | ||||
| Net loss available to ordinary shareholders - basic and diluted |
$ | (14,975 | ) | $ | (26,990 | ) | $ | (40,404 | ) | $ | (50,561 | ) | ||||
| Loss per share - basic and diluted | $ | (0.18 | ) | $ | (0.41 | ) | $ | (0.49 | ) | $ | (0.76 | ) | ||||
| Weighted-average shares outstanding - basic and diluted |
83,949,195 | 66,291,548 | 82,227,052 | 66,185,501 | ||||||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (In Thousands) (Unaudited) |
||||||||
2020 |
2020 |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 18,125 | $ | 3,923 | ||||
| Short-term investments | 144,618 | 116,871 | ||||||
| Trade accounts receivable, net | 4,518 | 5,402 | ||||||
| Inventories | 22,798 | 20,501 | ||||||
| Prepaid expenses and other current assets | 5,851 | 3,775 | ||||||
| Total current assets | 195,910 | 150,472 | ||||||
| Restricted cash | 9,031 | 9,017 | ||||||
| Property and equipment, net | 39,912 | 40,165 | ||||||
| Operating lease right-of-use assets | 21,557 | 21,493 | ||||||
| Intangible assets, net | 614 | 625 | ||||||
| Deferred income taxes | 237 | 237 | ||||||
| Other non-current assets | 4,634 | 4,454 | ||||||
| Total assets | $ | 271,895 | $ | 226,463 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,138 | $ | 4,826 | ||||
| Accrued compensation and benefits | 5,191 | 7,210 | ||||||
| Accrued expenses and other current liabilities | 17,410 | 15,490 | ||||||
| Current portion of long-term debt | 12,083 | — | ||||||
| Current portion of operating lease liability | 3,138 | 3,033 | ||||||
| Current portion of finance lease obligation | 577 | 598 | ||||||
| Total current liabilities | 43,537 | 31,157 | ||||||
| Long-term debt | 145,326 | 153,024 | ||||||
| Operating lease liability, less current portion | 20,282 | 19,914 | ||||||
| Finance lease obligation, less current portion | 921 | 1,117 | ||||||
| Defined benefit pension plan obligation | 7,169 | 6,353 | ||||||
| 7% Cumulative redeemable preference shares | 20,950 | 20,425 | ||||||
| Total liabilities | 238,185 | 231,990 | ||||||
| Total shareholders' equity (deficit) | 33,710 | (5,527 | ) | |||||
| Total liabilities and shareholders' equity (deficit) | $ | 271,895 | $ | 226,463 | ||||
| Condensed Consolidated Statements of Cash Flows | ||||||||
| (In Thousands) | ||||||||
| (Unaudited) | ||||||||
| Six months ended |
||||||||
| 2020 | 2019 | |||||||
| OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (40,404 | ) | $ | (50,561 | ) | ||
| Adjustments to reconcile net loss to net cash provided by operating activities: | ||||||||
| Depreciation, amortization and loss on disposal of fixed assets | 4,126 | 6,070 | ||||||
| Share-based compensation | 2,284 | 2,179 | ||||||
| Increase in deferred lease rentals | 346 | 148 | ||||||
| Swiss pension obligation | 516 | 363 | ||||||
| Amortization of deferred debt issue costs | 4,386 | 5,041 | ||||||
| Accrued preference share dividends | 525 | 525 | ||||||
| Income taxes | 32 | 27 | ||||||
| Net change in assets and liabilities: | ||||||||
| Trade accounts receivable, net | 1,093 | (1,161 | ) | |||||
| Inventories | (1,411 | ) | (2,874 | ) | ||||
| Accounts payable and accrued liabilities | 1,896 | (63 | ) | |||||
| Accrued compensation and benefits | (2,215 | ) | (1,764 | ) | ||||
| Other assets | (1,807 | ) | (648 | ) | ||||
| Net cash used in operating activities | (30,633 | ) | (42,718 | ) | ||||
| INVESTING ACTIVITIES: | ||||||||
| Increase in short-term investments | (72,247 | ) | (15,000 | ) | ||||
| Realization of short-term investments | 44,016 | 38,926 | ||||||
| Purchase of property and equipment | (2,069 | ) | (2,558 | ) | ||||
| Net cash (used in) / generated from investing activities | (30,300 | ) | 21,368 | |||||
| FINANCING ACTIVITIES: | ||||||||
| Repayment of finance leases | (356 | ) | (210 | ) | ||||
| Proceeds from drawdown of new debt | — | 25,000 | ||||||
| Debt issuance costs and fees paid to noteholders | — | (874 | ) | |||||
| Proceeds from issuance of ordinary shares and warrants | 80,838 | 377 | ||||||
| Net cash generated from financing activities | 80,482 | 24,293 | ||||||
| Effect of exchange rate fluctuations on cash and cash equivalents | (5,333 | ) | 277 | |||||
| Change in cash and cash equivalents | 14,216 | 3,220 | ||||||
| Beginning cash and cash equivalents | 12,940 | 11,603 | ||||||
| Ending cash and cash equivalents | $ | 27,156 | $ | 14,823 | ||||
| Supplemental cash flow disclosures: | ||||||||
| Income taxes paid | $ | — | $ | — | ||||
| Interest paid | $ | 8,765 | $ | 7,239 | ||||
| Reconciliation of cash, cash equivalents and restricted cash: | ||||||||
| Cash and cash equivalents | $ | 18,125 | $ | 5,816 | ||||
| Restricted cash | 9,031 | 9,007 | ||||||
| Total cash, cash equivalents and restricted cash | $ | 27,156 | $ | 14,823 | ||||
Source: Quotient Limited