- Development data provides positive results for extended IH microarray panel
- Field trial for initial Serological Disease microarray panel has commenced
- Reagent revenue growth of 15% in the quarter and 12% year to date
JERSEY,
“I am very pleased to report the progress which we have been able to make. We are well positioned with an ISO certified MosaiQ manufacturing system, a CE marked MosaiQ instrument and the resources required to bring a commercializable MosaiQ testing menu to the transfusion diagnostics market. The Quotient team continues to operate well to achieve the targets which we set earlier this fiscal year.” said
Extended Antigen Assay Performance
In development studies performed for the extended antigen microarray the following concordance data were achieved in sample sizes of between 120 to 280:
MosaiQ IH Microarray – Extended Antigen Typing
| Blood Group Antigen | A | B | D | C | c | E | e | K | k | Cw | ||||||||||
| Concordance | 100% | 100% | 100% | 100% | 100% | 99.6 | 100% | 100% | 100% | 100% | ||||||||||
| Blood Group Antigen | Kpa | Fya | Fyb | Jka | Jkb | M | N | S | Leb | P1 | ||||||||||
| Concordance | 100% | 99.5% | 100% | 100% | 100% | 100% | 99.1% | 99.4% | 100% | * | ||||||||||
* An additional assay for the P1 antigen is in the final stages of the print concentration phase of development.
These studies also demonstrate equivalent or improved performance for the antigen assays included on the initial IH microarray. Ongoing development plans include commencement of Verification and Validation for the extended antigen panel in the near future.
MosaiQ Platform
MosaiQ, Quotient's next-generation platform is designed to deliver fast, comprehensive antigen typing, antibody detection and serological and molecular disease screening, using a single low volume sample in a high throughput automated format. MosaiQ represents a transformative and highly disruptive unified diagnostic testing platform for transfusion diagnostics and beyond. Through MosaiQ, Quotient expects to deliver substantial value to its initial target market of donor testing laboratories 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.
Quotient Reconfirms the Following Regulatory and Commercial Milestones
- European Regulatory Approval – Quotient filed for European regulatory approval for its initial MosaiQ IH microarray in
September 2018 and continues to expect to file for the initial Serological Disease Screening (SDS) microarray in the first half of calendar 2019 - European Commercialization – Quotient has received invitations to participate in tenders once MosaiQ has obtained European approval for the initial IH microarray
IH Microarray Ongoing Development – Quotient continues to plan for a Verification and Validation study for the expanded IH antigen testing menu during the first half of calendar 2019- U.S. Field Trials – Quotient expects to commence U.S. field trials with the expanded antigen testing menu in the first half of calendar 2019
- U.S. Regulatory Approval – Quotient expects to file for U.S. and European regulatory approval for the expanded IH microarray in the second half of calendar 2019
Fiscal Third Quarter 2019 Financial Results
“The conventional reagent business recognized strong product sales of
Key revenue and profit results are summarized below (expressed in thousands)
| Quarter Ended | Nine Months Ended | |||||||||||||||
| Dec 31, | Dec 31 | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product sales —OEM Customers | $ | 4,719 | $ | 3,829 | $ | 14,744 | $ | 12,625 | ||||||||
| Product sales — direct customers and distributors | 2,004 | 1,824 | 6,090 | 5,164 | ||||||||||||
| Other revenues | — | 206 | 19 | 806 | ||||||||||||
| Total revenue | $ | 6,723 | $ | 5,859 | $ | 20,853 | $ | 18,595 | ||||||||
| Product sales from standing orders (%) | 67 | % | 76 | % | 67 | % | 75 | % | ||||||||
| Gross profit | $ | 2,537 | $ | 3,534 | $ | 8,050 | $ | 10,652 | ||||||||
| Gross profit as a % of total revenue | 37.7 | % | 60.3 | % | 38.6 | % | 57.3 | % | ||||||||
| Gross margin on product sales (%) | 37.7 | % | 58.9 | % | 38.5 | % | 55.3 | % | ||||||||
| Operating (loss) | $ | (19,028 | ) | $ | (17,095 | ) | $ | (58,629 | ) | $ | (52,062 | ) | ||||
Capital expenditures totaled
During the third quarter Quotient announced the closing of an underwritten public offering of 10,615,385 ordinary shares at a price to the public of
In
During the third quarter the Company entered into a first supplemental indenture to modify the terms of its previously issued Senior Notes as follows:
- extending the maturity date of the Senior Notes to
April 15, 2024 - revising the principal amortization schedule to delay by two years the initial redemption of the Senior Notes now set to commence on
April 15,2021 - revising the periods and redemption prices related to the optional redemption by the Company of the Senior Notes
- permitting the Company to issue up to an additional
$25.0 million aggregate principal amount of Senior Notes following the European CE marking of the Company's initial MosaiQTM IH Microarray
In consideration for these modifications, the Company agreed to pay to the noteholders a one-time consent payment of
Quotient ended the quarter with
Outlook for the Fiscal Year Ending
- Product revenue is expected to be in the range of
$27.6 to $27.8 million for the full fiscal year. Other revenues (product development fees) of approximately$0.45 million are also expected in the fiscal year. Forecasted other revenue assumes the receipt of milestone payments contingent upon achievement of regulatory milestones for certain products under development. The receipt of these milestone payments involves risks and uncertainties. - Operating loss, reflecting incremental investments in our development priorities, is expected to be in the range of
$75 to $78 million including approximately$18 million of non-cash expenses such as depreciation, amortization and stock compensation. - Capital expenditures are expected to be in the range of
$4 to $5 million .
Product sales in the fourth quarter of fiscal 2019 are expected to be in the range of
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
Quotient is a commercial-stage diagnostics company committed to ensuring clinical excellence and increasing the efficiency in the lab through the provision of innovative testing methods for existing tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQ™ 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
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 application of MosaiQ to infectious disease diagnostics), current estimates of fourth quarter and full year fiscal 2019 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
The Quotient logo and MosaiQ™ are registered trademarks or trademarks of
CONTACT:
| Quotient Limited Condensed Consolidated Statements of Comprehensive Loss (in thousands, except share and per share amounts) (unaudited) |
||||||||||||||||
| Quarter Ended | Nine Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product sales | $ | 6,723 | $ | 5,653 | $ | 20,834 | $ | 17,789 | ||||||||
| Other revenues | — | 206 | 19 | 806 | ||||||||||||
| Total revenue | 6,723 | 5,859 | 20,853 | 18,595 | ||||||||||||
| Cost of revenue | 4,186 | 2,325 | 12,803 | 7,943 | ||||||||||||
| Gross profit | 2,537 | 3,534 | 8,050 | 10,652 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales and marketing | 2,233 | 1,910 | 6,359 | 5,461 | ||||||||||||
| Research and development, net | 11,788 | 11,929 | 37,356 | 37,944 | ||||||||||||
| General and administrative expense | 7,544 | 6,790 | 22,964 | 19,309 | ||||||||||||
| Total operating expense | 21,565 | 20,629 | 66,679 | 62,714 | ||||||||||||
| Operating loss | (19,028 | ) | (17,095 | ) | (58,629 | ) | (52,062 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest expense, net | (5,679 | ) | (3,249 | ) | (14,614 | ) | (11,656 | ) | ||||||||
| Other, net | (1,536 | ) | 33 | (5,516 | ) | 1,478 | ||||||||||
| Other expense, net | (7,215 | ) | (3,216 | ) | (20,130 | ) | (10,178 | ) | ||||||||
| Loss before income taxes | (26,243 | ) | (20,311 | ) | (78,759 | ) | (62,240 | ) | ||||||||
| Provision for income taxes | (11 | ) | — | (33 | ) | — | ||||||||||
| Net loss | $ | (26,254 | ) | $ | (20,311 | ) | $ | (78,792 | ) | $ | (62,240 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Change in fair value of effective portion of foreign currency cash flow hedges |
$ | 41 | $ | (64 | ) | $ | (320 | ) | $ | 409 | ||||||
| Unrealized gain on short-term investments | 169 | (7 | ) | 416 | 25 | |||||||||||
| Foreign currency gain (loss) | (176 | ) | (168 | ) | 554 | 1,144 | ||||||||||
| Provision for pension benefit obligation | 35 | 45 | 107 | 132 | ||||||||||||
| Other comprehensive income (loss) | 69 | (194 | ) | 757 | 1,710 | |||||||||||
| Comprehensive loss | $ | (26,185 | ) | $ | (20,505 | ) | $ | (78,035 | ) | $ | (60,530 | ) | ||||
| Net loss available to ordinary shareholders - basic and diluted |
$ | (26,254 | ) | $ | (20,311 | ) | $ | (78,792 | ) | $ | (62,240 | ) | ||||
| Loss per share - basic and diluted | $ | (0.46 | ) | $ | (0.47 | ) | $ | (1.53 | ) | $ | (1.58 | ) | ||||
| Weighted-average shares outstanding - basic and diluted |
56,619,356 | 43,353,506 | 51,512,352 | 39,274,570 | ||||||||||||
| Quotient Limited Condensed Consolidated Balance Sheets (In Thousands) (Unaudited) |
||||||||
| December 31, 2018 |
March 31, 2018 |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,468 | $ | 20,165 | ||||
| Short-term investments | 103,202 | 5,669 | ||||||
| Trade accounts receivable, net | 2,356 | 2,862 | ||||||
| Inventories | 15,306 | 16,278 | ||||||
| Prepaid expenses and other current assets | 2,678 | 7,065 | ||||||
| Total current assets | 128,010 | 52,039 | ||||||
| Restricted cash | 7,510 | 5,040 | ||||||
| Property and equipment, net | 49,286 | 60,156 | ||||||
| Intangible assets, net | 759 | 914 | ||||||
| Deferred income taxes | 616 | 649 | ||||||
| Other non-current assets | 4,584 | 5,043 | ||||||
| Total assets | $ | 190,765 | $ | 123,841 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,996 | $ | 5,441 | ||||
| Accrued compensation and benefits | 4,337 | 5,312 | ||||||
| Accrued expenses and other current liabilities | 10,390 | 15,340 | ||||||
| Current portion of long-term debt | — | — | ||||||
| Current portion of deferred lease rental benefit | 440 | 443 | ||||||
| Capital lease obligation | 469 | 515 | ||||||
| Total current liabilities | 18,632 | 27,051 | ||||||
| Long-term debt | 120,044 | 85,063 | ||||||
| Deferred lease rental benefit, less current portion | 1,056 | 443 | ||||||
| Capital lease obligation, less current portion | 943 | 1,422 | ||||||
| Defined benefit pension plan obligation | 6,322 | 6,168 | ||||||
| 7% Cumulative redeemable preference shares | 19,113 | 18,325 | ||||||
| Total liabilities | 166,110 | 138,472 | ||||||
| Total shareholders' equity (deficit) | 24,655 | (14,631 | ) | |||||
| Total liabilities and shareholders' equity (deficit) | $ | 190,765 | $ | 123,841 | ||||
| Quotient Limited Condensed Consolidated Statements of Cash Flows (In Thousands) (Unaudited) |
||||||||
| Nine months ended December 31, |
||||||||
| 2018 | 2017 | |||||||
| OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | (78,792 | ) | $ | (62,240 | ) | ||
| Adjustments to reconcile net loss to net cash provided by operating activities: | ||||||||
| Depreciation and amortization | 9,503 | 7,678 | ||||||
| Share-based compensation | 3,576 | 3,458 | ||||||
| Increase in (amortization of) deferred lease rental benefit | 266 | (324 | ) | |||||
| Swiss pension obligation | 453 | 494 | ||||||
| Amortization of deferred debt issue costs | 4,097 | 3,383 | ||||||
| Accrued preference share dividends | 788 | 788 | ||||||
| Deferred income taxes | 33 | — | ||||||
| Net change in assets and liabilities: | ||||||||
| Trade accounts receivable, net | 315 | 681 | ||||||
| Inventories | 147 | (2,347 | ) | |||||
| Accounts payable and accrued liabilities | (5,076 | ) | (4,066 | ) | ||||
| Accrued compensation and benefits | (664 | ) | (886 | ) | ||||
| Other assets | 3,833 | 456 | ||||||
| Net cash used in operating activities | (61,521 | ) | (52,925 | ) | ||||
| INVESTING ACTIVITIES: | ||||||||
| Increase in short-term investments | (119,000 | ) | (78,000 | ) | ||||
| Realization of short-term investments | 21,883 | 66,403 | ||||||
| Purchase of property and equipment | (3,047 | ) | (17,343 | ) | ||||
| Purchase of intangible assets | (3 | ) | (68 | ) | ||||
| Net cash used in investing activities | (100,167 | ) | (29,008 | ) | ||||
| FINANCING ACTIVITIES: | ||||||||
| Repayment of finance leases | (358 | ) | (135 | ) | ||||
| Proceeds from drawdown of new debt | 36,000 | — | ||||||
| Issue costs of new debt | (5,113 | ) | — | |||||
| Proceeds from issuance of ordinary shares and warrants | 113,745 | 84,985 | ||||||
| Net cash generated from financing activities | 144,274 | 84,850 | ||||||
| Effect of exchange rate fluctuations on cash, cash equivalents and restricted cash | 4,187 | (1,521 | ) | |||||
| Change in cash, cash equivalents and restricted cash | (13,227 | ) | 1,396 | |||||
| Beginning cash, cash equivalents and restricted cash | 25,205 | 9,794 | ||||||
| Ending cash, cash equivalents and restricted cash | $ | 11,978 | $ | 11,190 | ||||
| Supplemental cash flow disclosures: | ||||||||
| Income taxes paid | $ | — | $ | — | ||||
| Interest paid | $ | 11,435 | $ | 5,068 | ||||
| Reconciliation of cash, cash equivalents and restricted cash: | ||||||||
| Cash and cash equivalents | $ | 4,468 | $ | 6,150 | ||||
| Restricted cash | 7,510 | 5,040 | ||||||
| Total cash, cash equivalents and restricted cash | $ | 11,978 | $ | 11,190 | ||||
Source: Quotient Limited