- New Chief Technology Officer (CTO) appointed to accelerate innovation and further strengthen organizational capabilities
- Continuing robust progress in advancing the MosaiQ transfusion diagnostics menu
- Actively preparing for commercialization of MosaiQ products through planned evaluation placements in
Europe - Exploring potential partnerships across a broad range of applications for the multimodal and multiplexing MosaiQ by Quotient system
- Continued strong Alba by Quotient revenues with high single digit growth in Q4 FY21,
exceeded full-year guidance - Further strengthened cash position through private placement of Convertible Senior Notes
JERSEY,
Chief Technology Officer (CTO) - The Company has recruited Dr.
“We are delighted to welcome Michael to the Quotient team as our new CTO, a role to which he is perfectly suited. I’ve known Michael for a number of years, and I have seen the extent of his professional contributions and have followed his executive career progression. I’m confident that he’s the right person to further accelerate our innovation development strategy and take our team to the next level,” said Manuel O. Méndez, Chief Executive Officer of Quotient.
“Turning technology into clinical solutions that create medical and operational efficiency value for patients and customers, is a great passion of mine. I look forward to working with the teams in
Michael holds a Ph.D. in Biology from the Max-Planck-
MosaiQ by Quotient Solution – The Company continues to make significant progress toward commercialization of its transfusion diagnostics menu:
- Immunohematology (IH): Optimization of the Expanded Immunohematology (IH) microarray has been completed and European field trials are set to commence in
June 2021 , to be followed shortly thereafter by US field trials. Qualification visits have been conducted at all sites and the MosaiQ multimodal multiplexing system has been installed at all trial locations inEurope and the US. - Serological Disease Screening (SDS): Development of the Expanded SDS microarray is ongoing and European and US Field Trials are expected to commence at the end of the current calendar year with a CE mark submission in Q1 FY2023. Initial SDS 510(k) submission is on-track to be submitted by year-end.
- Molecular Disease Screening (MDS): The Company's internal testing suggests the MDS microarray will deliver a level of accuracy and sensitivity comparable to the most sensitive widely available molecular disease screening tests, using the flexible and efficient MosaiQ platform.
Commercial Readiness – The MosaiQ expanded IH microarray and the already CE marked Initial Serological Disease Screening (SDS) microarray are on track for European commercial launch at around year-end. Approximately twenty-five potential tenders in FY2022 and FY2023 have been identified and in anticipation of participating in those tenders the Company's commercial team has a target of conducting evaluations at a minimum of twelve sites by Q1 FY2023. The Company believes its commercial team has all the resources required to successfully execute the launch of these products.
“I’m excited about the progress our team has made to launch the MosaiQ solution. This is key as we expand our partnership with our customers to address their needs and contribute to optimizing the safety of the blood supply,” said Manuel O. Méndez, Chief Executive Officer of Quotient.
Applications Across Various Testing Market Segments – To leverage the power and flexibility of the MosaiQ multimodal multiplexing system, the Company is exploring new opportunities in various market segments, notably the clinical diagnostics and plasma diagnostics segments.
Alba by Quotient – The Alba by Quotient reagent business generated strong revenue growth during fiscal 2021, with product revenues growing 9.2% for the full year and 7.4% in the fourth quarter over fiscal 2020.
Financial position – The Company significantly strengthened its cash position with a private placement of
“The strengthening of our financial position allows us to expand our pipeline and fund our commercial endeavors,” said Manuel O. Méndez, Chief Executive Officer of Quotient.
As previously reported, in
Fiscal Fourth Quarter and Full Year Financial Results
The Alba by Quotient product revenue growth for the fiscal year was driven by 9.5% growth in sales to original equipment manufacturer (OEM) customers, while direct product sales grew 8.7%. In the fourth quarter, gross margin on product sales was 45.8% compared to 45.6% in the fourth quarter of fiscal 2020, reflecting marginal improvements in sales mix. For fiscal year 2021 gross margin on product sales also improved year on year from 43.7% to 43.9%. Other revenues for the year ended
Key revenue and profit results are summarized below (expressed in thousands, except percentages)
| Quarter Ended | Year Ended | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product sales —OEM Customers | $ | 6,470 | $ | 5,863 | $ | 23,224 | $ | 21,217 | ||||||||
| Product sales — direct customers and distributors | 2,870 | 2,837 | 11,287 | 10,384 | ||||||||||||
| Product sales - MosaiQ | 240 | — | 1,276 | — | ||||||||||||
| Other revenues | 58 | — | 7,592 | 1,055 | ||||||||||||
| Total revenue | $ | 9,638 | $ | 8,700 | $ | 43,379 | $ | 32,656 | ||||||||
| Product sales from standing orders (%) | 64 | % | 68 | % | 67 | % | 70 | % | ||||||||
| Gross profit | $ | 4,447 | $ | 3,964 | $ | 23,305 | $ | 14,856 | ||||||||
| Gross profit as a % of total revenue | 46.1 | % | 45.6 | % | 53.7 | % | 45.5 | % | ||||||||
| Gross margin on product sales (%) | 45.8 | % | 45.6 | % | 43.9 | % | 43.7 | % | ||||||||
| Operating (loss) | $ | (27,964 | ) | $ | (21,469 | ) | $ | (82,508 | ) | $ | (80,691 | ) | ||||
The operating loss for the quarter and the year ended
Capital expenditures totaled
At
As at
Outlook for the Fiscal Year Ending
- Total product sales of Alba by Quotient reagents in the range of
$35.5 to$36.5 million compared to product sales in fiscal 2020 of$34.5 million . 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
$6 to$6.5 million - Alba by Quotient product sales in the first quarter of fiscal 2022 are expected to be within the range of
$8.9 to$9.4 million , compared with$8.8 million for the first quarter of fiscal 2021.
The Company is not providing guidance on the operating loss.
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
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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 first quarter and full year fiscal 2022 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; 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) |
||||||||||||
| Year ended |
||||||||||||
| 2021 | 2020 | 2019 | ||||||||||
| Revenue: | ||||||||||||
| Product sales | $ | 35,787 | $ | 31,601 | $ | 28,665 | ||||||
| Other revenues | 7,592 | 1,055 | 469 | |||||||||
| Total revenue | 43,379 | 32,656 | 29,134 | |||||||||
| Cost of revenue | (20,074 | ) | (17,800 | ) | (17,230 | ) | ||||||
| Gross profit | 23,305 | 14,856 | 11,904 | |||||||||
| Operating expenses: | ||||||||||||
| Sales and marketing | (9,849 | ) | (9,853 | ) | (8,637 | ) | ||||||
| Research and development, net of government grants | (54,168 | ) | (53,744 | ) | (50,677 | ) | ||||||
| General and administrative expense: | ||||||||||||
| Compensation expense in respect of share | ||||||||||||
| options and management equity incentives | (4,984 | ) | (4,467 | ) | (4,957 | ) | ||||||
| Other general and administrative expenses | (36,812 | ) | (27,483 | ) | (26,588 | ) | ||||||
| Total general and administrative expense | (41,796 | ) | (31,950 | ) | (31,545 | ) | ||||||
| Total operating expense | (105,813 | ) | (95,547 | ) | (90,859 | ) | ||||||
| Operating loss | (82,508 | ) | (80,691 | ) | (78,955 | ) | ||||||
| Other income (expense): | ||||||||||||
| Interest expense, net | (25,918 | ) | (23,859 | ) | (20,018 | ) | ||||||
| Other, net | 1,882 | 2,438 | (6,369 | ) | ||||||||
| Other income (expense), net | (24,036 | ) | (21,421 | ) | (26,387 | ) | ||||||
| Loss before income taxes | (106,544 | ) | (102,112 | ) | (105,342 | ) | ||||||
| Provision for income taxes | (1,926 | ) | (661 | ) | (44 | ) | ||||||
| Net loss | $ | (108,470 | ) | $ | (102,773 | ) | $ | (105,386 | ) | |||
| Other comprehensive income (loss): | ||||||||||||
| Change in fair value of effective portion of | ||||||||||||
| foreign currency cash flow hedges | $ | 582 | $ | (157 | ) | $ | (123 | ) | ||||
| Unrealized gain (loss) on short-term investments | (898 | ) | 554 | 796 | ||||||||
| Foreign currency gain (loss) | (1,216 | ) | (2,702 | ) | 1,964 | |||||||
| Provision for pension benefit obligation | 622 | 2,034 | (887 | ) | ||||||||
| Other comprehensive loss, net | (910 | ) | (271 | ) | 1,750 | |||||||
| Comprehensive loss | $ | (109,380 | ) | $ | (103,044 | ) | $ | (103,636 | ) | |||
| Net loss available to ordinary shareholders | ||||||||||||
| - basic and diluted | $ | (108,470 | ) | $ | (102,773 | ) | $ | (105,386 | ) | |||
| Loss per share - basic and diluted | $ | (1.18 | ) | $ | (1.44 | ) | $ | (1.92 | ) | |||
| Weighted-average shares outstanding - basic and | ||||||||||||
| diluted | 91,637,966 | 71,610,035 | 54,874,391 | |||||||||
Condensed Consolidated Balance Sheets (In Thousands) (Unaudited) |
||||||||
2021 |
2020 |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 45,673 | $ | 3,923 | ||||
| Short-term investments | 65,999 | 116,871 | ||||||
| Trade accounts receivable, net | 5,323 | 5,402 | ||||||
| Inventories | 22,011 | 20,501 | ||||||
| Prepaid expenses and other current assets | 4,870 | 3,775 | ||||||
| Total current assets | 143,876 | 150,472 | ||||||
| Restricted cash | 9,024 | 9,017 | ||||||
| Property and equipment, net | 38,530 | 40,165 | ||||||
| Operating lease right-of-use assets | 22,011 | 21,493 | ||||||
| Intangible assets, net | 619 | 625 | ||||||
| Deferred income taxes | 255 | 237 | ||||||
| Other non-current assets | 4,956 | 4,454 | ||||||
| Total assets | $ | 219,271 | $ | 226,463 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,659 | $ | 4,826 | ||||
| Accrued compensation and benefits | 11,833 | 7,210 | ||||||
| Accrued expenses and other current liabilities | 13,889 | 15,490 | ||||||
| Current portion of long-term debt | 24,167 | — | ||||||
| Current portion of operating lease liability | 3,446 | 3,033 | ||||||
| Current portion of finance lease obligation | 835 | 598 | ||||||
| Total current liabilities | 58,829 | 31,157 | ||||||
| Long-term debt, less current portion | 137,936 | 153,024 | ||||||
| Operating lease liability, less current portion | 20,907 | 19,914 | ||||||
| Finance lease obligation, less current portion | 445 | 1,117 | ||||||
| Deferred income taxes | 1,824 | — | ||||||
| Defined benefit pension plan obligation | 6,896 | 6,353 | ||||||
| 7% Cumulative redeemable preference shares | 21,475 | 20,425 | ||||||
| Total liabilities | 248,312 | 231,990 | ||||||
| Commitments and contingencies | — | — | ||||||
| Shareholders' equity (deficit): | ||||||||
| Ordinary shares (nil par value) 101,264,412 and 80,398,326 issued and outstanding at |
540,813 | 459,931 | ||||||
| Additional paid in capital | 38,116 | 33,132 | ||||||
| Accumulated other comprehensive loss | (16,065 | ) | (15,155 | ) | ||||
| Accumulated deficit | (591,905 | ) | (483,435 | ) | ||||
| Total shareholders' equity (deficit) | (29,041 | ) | (5,527 | ) | ||||
| Total liabilities and shareholders' equity (deficit) | $ | 219,271 | $ | 226,463 | ||||
Condensed Consolidated Statements of Cash Flows (In Thousands) (Unaudited) |
||||||||||||
| Year ended |
||||||||||||
| 2021 | 2020 | 2019 | ||||||||||
| OPERATING ACTIVITIES: | ||||||||||||
| Net loss | $ | (108,470 | ) | $ | (102,773 | ) | $ | (105,386 | ) | |||
| Adjustments to reconcile net loss to net cash provided by | ||||||||||||
| operating activities: | ||||||||||||
| Depreciation, amortization and loss on disposal of fixed assets | 8,620 | 12,276 | 12,767 | |||||||||
| Share-based compensation | 4,984 | 4,467 | 4,957 | |||||||||
| Increase in deferred lease rentals | 726 | 293 | 372 | |||||||||
| Swiss pension obligation | 1,054 | 756 | 575 | |||||||||
| Amortization of deferred debt issue costs | 9,079 | 7,043 | 5,908 | |||||||||
| Impairment of short term investments | 2,285 | — | — | |||||||||
| Accrued preference share dividends | 1,050 | 1,050 | 1,050 | |||||||||
| Income taxes | 1,926 | 368 | 44 | |||||||||
| Net change in assets and liabilities: | ||||||||||||
| Trade accounts receivable, net | 568 | (2,177 | ) | (637 | ) | |||||||
| Inventories | (475 | ) | (4,967 | ) | (93 | ) | ||||||
| Accounts payable and accrued liabilities | (2,514 | ) | 2,456 | 370 | ||||||||
| Accrued compensation and benefits | 4,039 | 1,218 | 1,121 | |||||||||
| Other assets | (454 | ) | (656 | ) | 3,297 | |||||||
| Net cash used in operating activities | (77,582 | ) | (80,646 | ) | (75,655 | ) | ||||||
| INVESTING ACTIVITIES: | ||||||||||||
| Increase in short-term investments | (87,247 | ) | (95,000 | ) | (119,000 | ) | ||||||
| Realization of short-term investments | 134,936 | 69,412 | 34,735 | |||||||||
| Purchase of property and equipment | (4,240 | ) | (4,598 | ) | (4,791 | ) | ||||||
| Purchase of intangible assets | — | (2 | ) | (3 | ) | |||||||
| Net cash from (used in) investing activities | 43,449 | (30,188 | ) | (89,059 | ) | |||||||
| FINANCING ACTIVITIES: | ||||||||||||
| Repayment of finance leases | (633 | ) | (524 | ) | (486 | ) | ||||||
| Proceeds from drawdown of new debt | — | 25,000 | 36,000 | |||||||||
| Debt issue costs | — | (874 | ) | (1,216 | ) | |||||||
| Fee paid to noteholders | — | — | (3,900 | ) | ||||||||
| Proceeds from issuance of ordinary shares and warrants | 80,881 | 90,973 | 115,024 | |||||||||
| Net cash generated from financing activities | 80,248 | 114,575 | 145,422 | |||||||||
| Effect of exchange rate fluctuations on cash and cash equivalents | (4,358 | ) | (2,404 | ) | 5,690 | |||||||
| Change in cash and cash equivalents | 41,757 | 1,337 | (13,602 | ) | ||||||||
| Beginning cash and cash equivalents | 12,940 | 11,603 | 25,205 | |||||||||
| Ending cash and cash equivalents | $ | 54,697 | $ | 12,940 | $ | 11,603 | ||||||
| Supplemental cash flow disclosures: | ||||||||||||
| Income taxes paid | $ | — | $ | — | $ | — | ||||||
| Interest paid | $ | 17,529 | $ | 15,776 | $ | 11,838 | ||||||
| Reconciliation of cash, cash equivalents and restricted cash: | ||||||||||||
| Cash and cash equivalents | $ | 45,673 | $ | 3,923 | $ | 4,096 | ||||||
| Restricted cash | $ | 9,024 | $ | 9,017 | $ | 7,507 | ||||||
| Total cash, cash equivalents and restricted cash | $ | 54,697 | $ | 12,940 | $ | 11,603 | ||||||
Source: Quotient Limited