Quotient Limited Provides Fourth Quarter Fiscal 2022 Results and Business Update
Quotient Limited (QTNT) reported FY 2022 revenue of $38.5 million amid ongoing restructuring efforts to improve liquidity. The company's cash and investments stood at $83.2 million as of March 31, 2022. It secured $1.4 million in orders for its CE-marked MosaiQ solution and expects to engage in over 20 European immunohematology tenders in the next 18 months. However, operational losses persist, with net losses accumulating to $725 million. The company anticipates fiscal 2023 sales between $39 million and $42 million.
- Secured $1.4 million in orders for MosaiQ in Q1 FY2023.
- Cash and investments of $83.2 million provide operational flexibility.
- Expecting sales in FY2023 to range between $39 million and $42 million.
- Operational losses of $26.9 million in Q4 FY2022.
- Accumulated deficit of $725 million as of March 31, 2022.
- Increased interest expense due to debt issuance.
- Financial Position
- Amended Secured Notes: Reduces the company’s cash obligations by approximately
$93 million over the next 36 months - Announces Public Equity Offering: Improving liquidity runway
- FY 2022 Revenue of
$38.5 Million $83.2 million in cash and investments as of March 31, 2022
- Amended Secured Notes: Reduces the company’s cash obligations by approximately
- MosaiQ™ Solution
- Commercial Execution:
- Extended IH Launch: Commercialization is underway;
$1.4 million of MosaiQ orders in Q1 FY2023; Multiple MosaiQ instruments shipped to customers - Tenders: Actively engaged in Immunohematology (IH) donor tenders;
20 European IH donor tender submissions expected in the next 18 months - Distribution Network: 9 international agreements in place and expanding global distribution network
- Extended IH Launch: Commercialization is underway;
- Transfusion Diagnostics: Extended Serological Disease Screening (SDS) microarray panel continues to progress towards EU commercial launch in calendar year 2023
- Clinical Diagnostics: Partnership with Theradiag to accelerate time to the development of Autoimmune microarray with optimized costs; Will expand access to
$2 billion autoimmune IVD specialty market with MosaiQ; Expected entry into EU and US markets in calendar year 2023
- Scientific & Medical Affairs: Successful KOL event held providing expert validation in real-world settings; Innovator’s Circle community is comprised of 8 experts to enable better patient care; Launch of Company’s international research program, Investigator Initiated Research (IIR), with Centre Pasteur in Cameroon (CPC)
- Commercial Execution:
JERSEY, Channel Islands, June 24, 2022 (GLOBE NEWSWIRE) -- Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (Quotient or the Company), headquartered in Eysins, Switzerland, today reported its fourth quarter fiscal 2022 key financial results and provided an update on recent business developments and key upcoming milestones.
“I am deeply proud of the tremendous progress we have achieved at Quotient during my first year as CEO,” said Manuel O. Mendez, Chief Executive Officer of Quotient. “We received European CE mark approval of the MosaiQ Extended IH microarray in March, and we are announcing a financing with key equity and debt restructuring to strengthen our balance sheet and provide the necessary capital to improve our liquidity runway and advance our commercial and clinical execution strategy. We have a talented and experienced management team to lead us through this period of exciting growth and shareholder value creation for our company.”
Financial Position:
The Company reported cash, cash equivalents and investments of
MosaiQ Solution
Commercial Execution:
Extended Immunohematology (IH) Launch: The Company recently secured
Tenders: The Company will continue to participate in upcoming IH tenders in Europe and expanding distribution outside of the US. There are over 20 IH tenders which have been identified by the Company and which it intends to pursue across Europe when available for submission over the next 18 months. Quotient remains active in preparing for new tenders in the rest of the world where CE marking is accepted.
Distribution: In addition, the Company is focused on expanding its distribution footprint across the major international geographies. The Commercial team has signed nine international agreements with distributors.
Transfusion Diagnostics:
Immunohematology (IH) Microarray: In March, the Company received CE Mark for the MosaiQ Extended Immunohematology (IH) Microarray. The receipt of CE Mark allows the Company to commercialize the microarray for use with the Company’s MosaiQ instrument across the European Union and other CE Mark recognizing geographies.
The Company’s MosaiQ platform offers an all-in-one, fully automated, high-performance solution in blood-testing laboratories and other settings. The IH microarray offers extended phenotyping, Antibody Screening and Antigen Typing, including ABO forward and reverse grouping. Laboratories and clinicians may use the platform to generate comprehensive characterization of blood donor samples through a single test procedure.
Serological Disease Screening (SDS) Microarray: The Company has made advances on the Extended SDS panel and continues to expect to submit an application in the EU for CE mark in the second half of calendar year 2022. The Company expects an EU commercial launch and a US FDA BLA submission in the first half of calendar year 2023.
Clinical Diagnostics:
The recently announced Theradiag partnership serves as a key step to introduce the multimodal, multiplexed MosaiQ solution to various clinical diagnostic specialty segments with the aim of enabling clinical labs to simplify the complexity of diagnostic algorithms and accelerate standards of care. The first application covered by their new collaboration will be a solution for Connective Tissue Diseases (CTD). The autoimmune IVD pathway to market has a tighter turnaround time due to different regulatory requirements and is at a lower cost than blood transfusion. The Company estimates that autoimmune diagnostics would provide an additional
Scientific & Medical Affairs:
The Company hosted a successful key opinion leader (KOL) webinar (available on the Quotient website) with Dr. Christophe Martinaud (MD, PhD), on the current landscape and unmet needs within blood grouping and donor disease screening, providing expert validation for the MosaiQ solution.
To further strengthen scientific and medical synergies, a total of eight members are participating in the MosaiQ Innovator’s Circle initiative. The goal of the initiative is to create a community of experts at institutions across the world who focus on transfusion medicine and clinical diagnostics. Members partner with Quotient to create innovation and evidence generation to improve patient care and laboratory efficiencies.
In addition, Quotient has established an Investigator Initiated Research (IIR) program open to all healthcare professionals who wish to study the clinical and economic impact of the MosaiQ system.
The Company recently announced an international partnership with Centre Pasteur du Cameroon (CPC) for the IIR program. This partnership will provide Quotient’s R&D team with rare HIV samples and will sponsor young scientists studying infectious diseases in Africa.
Additionally, the Company established a new Scientific Advisory Board relating to Autoimmunity and Allergy and has published a white paper focused on how increasing phenotype-matched blood provided to hospital patients is expected to make transfusion medicine safer and more effective.
Fiscal Fourth Quarter Financial Results:
The Alba by Quotient reagent business generated product sales of
Key revenue and profit results are summarized below (expressed in thousands, except percentages)
| Quarter Ended March 31, | Year Ended March 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (in thousands, except percentages) | ||||||||||||||||
| Revenue: | ||||||||||||||||
| Product sales - OEM customers | $ | 6,654 | $ | 6,470 | $ | 25,653 | $ | 23,224 | ||||||||
| Product sales - direct customers and distributors | 3,132 | 2,870 | 12,539 | 11,287 | ||||||||||||
| Product sales - MosaiQ | - | 240 | 91 | 1,276 | ||||||||||||
| Other revenues | - | 58 | 231 | 7,592 | ||||||||||||
| Total revenue | $ | 9,786 | $ | 9,638 | $ | 38,514 | $ | 43,379 | ||||||||
| Product sales from standing purchase orders (%) | 69 | % | 64 | % | 66 | % | 67 | % | ||||||||
| Gross profit | $ | 3,795 | $ | 4,447 | $ | 14,944 | $ | 23,305 | ||||||||
| Gross profit as a % of total revenue | 39 | % | 46 | % | 39 | % | 54 | % | ||||||||
| Gross margin on product sales (%) | 39 | % | 46 | % | 38 | % | 44 | % | ||||||||
| Operating loss | $ | (26,865 | ) | $ | (28,458 | ) | $ | (103,827 | ) | $ | (82,697 | ) | ||||
Total operating expenses for the quarter decreased by
Capital expenditures totaled
Interest expense for the quarter increased by
As of March 31, 2022, Quotient had
Of the
Outlook for the Fiscal Year Ending March 31, 2023
- The Company expects total sales in the current fiscal year will be in the range of
$39 million to$42 million compared to$38.5 million in FY 2022. - Capital expenditures for fiscal year 2023 are expected to be in the range of
$5 million to$10 million . - The Company estimates that cash used for operations for fiscal year 2023 will be in the range of
$6.5 million to$7.5 million per month (excluding debt service cost and capital expenditures).
The accompanying consolidated financial statements have been prepared on a basis which assumes that Quotient will continue as a going concern. However, the Company has incurred net losses from operations in each year since it commenced operations in 2007 and had an accumulated deficit of
Conference Call:
Quotient will host a conference call on June 24th, 2022, at 8:00 a.m. Eastern Time to provide a business update. Participants may access the call by dialing 1-877-407-0784 in the U.S. or +1-201-689-8561 outside the U.S. The access code is 13729874. The conference call will be webcast live on the Company’s website at www.quotientbd.com or by using the following webcast link.
A replay of this conference call will be available through July 8th, 2022, by dialing 1-877-407-0784 in the U.S. or +1-201-689-8561 outside the U.S. The access code is 13729874.
About Quotient Limited
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. The MosaiQ solution, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. The MosaiQ solution is designed to be a game-changing solution, which Quotient believes will increase efficiencies, improve clinical practice, and deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Switzerland, Scotland, US, and the UAE.
The Quotient logo, Quotient MosaiQ and MosaiQ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.
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 full year fiscal 2023 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 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, Quotient MosaiQ and MosaiQ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.
CONTACT: Investor Relations, ir@quotientbd.com; +41 22 545 52 26
| Quotient Limited Condensed Consolidated Statements of Comprehensive Loss (in thousands, except share and per share amounts) | ||||||||
| Year ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Revenue: | ||||||||
| Product sales | $ | 38,283 | $ | 35,787 | ||||
| Other revenues | 231 | 7,592 | ||||||
| Total revenue | 38,514 | 43,379 | ||||||
| Cost of revenue | (23,569 | ) | (20,074 | ) | ||||
| Gross profit | 14,944 | 23,305 | ||||||
| Operating expenses: | ||||||||
| Sales and marketing | (11,023 | ) | (9,849 | ) | ||||
| Research and development, net of government grants | (58,691 | ) | (53,727 | ) | ||||
| General and administrative expense: | ||||||||
| Compensation expense in respect of share options and management equity incentives | (6,951 | ) | (4,984 | ) | ||||
| Other general and administrative expenses | (42,107 | ) | (37,442 | ) | ||||
| Total general and administrative expense | (49,058 | ) | (42,426 | ) | ||||
| Total operating expense | (118,771 | ) | (106,002 | ) | ||||
| Operating loss | (103,827 | ) | (82,697 | ) | ||||
| Other income (expense): | ||||||||
| Interest expense, net | (31,954 | ) | (29,804 | ) | ||||
| Other, net | 11,612 | 2,723 | ||||||
| Other income (expense), net | (20,342 | ) | (27,081 | ) | ||||
| Loss before income taxes | (124,169 | ) | (109,778 | ) | ||||
| Provision for income taxes | (961 | ) | (1,254 | ) | ||||
| Net loss | $ | (125,130 | ) | $ | (111,032 | ) | ||
| Other comprehensive income (loss): | ||||||||
| Change in fair value of effective portion of foreign currency cash flow hedges | $ | (355 | ) | $ | 582 | |||
| Unrealized loss on short-term investments | (186 | ) | (898 | ) | ||||
| Foreign currency gain (loss) | 6,007 | (2,057 | ) | |||||
| Provision for pension benefit obligation | 2,941 | 447 | ||||||
| Other comprehensive income (loss), net | 8,407 | (1,926 | ) | |||||
| Comprehensive loss | $ | (116,723 | ) | $ | (112,958 | ) | ||
| Net loss available to ordinary shareholders - basic and diluted | $ | (125,130 | ) | $ | (111,032 | ) | ||
| Loss per share - basic and diluted | $ | (1.23 | ) | $ | (1.21 | ) | ||
| Weighted-average shares outstanding - basic and diluted | 101,910,562 | 91,637,966 | ||||||
| Quotient Limited Condensed Consolidated Balance Sheets (In thousands) | ||||||||
| March 31, 2022 | March 31, 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 65,059 | $ | 45,673 | ||||
| Short-term investments | 2,626 | 65,999 | ||||||
| Trade accounts receivable, net | 6,272 | 5,323 | ||||||
| Inventories | 22,036 | 22,011 | ||||||
| Prepaid expenses and other current assets | 5,761 | 4,870 | ||||||
| Total current assets | 101,754 | 143,876 | ||||||
| Restricted cash | 8,744 | 9,024 | ||||||
| Long-term investments | 15,467 | — | ||||||
| Property and equipment, net | 33,242 | 39,071 | ||||||
| Operating lease right-of-use assets | 29,411 | 22,011 | ||||||
| Intangible assets, net | 520 | 619 | ||||||
| Deferred income taxes | 123 | 255 | ||||||
| Other non-current assets | 4,728 | 4,956 | ||||||
| Total assets | $ | 193,989 | $ | 219,812 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,524 | $ | 4,659 | ||||
| Accrued compensation and benefits | 8,503 | 12,343 | ||||||
| Accrued expenses and other current liabilities | 15,729 | 14,009 | ||||||
| Current portion of long-term debt | — | 24,167 | ||||||
| Current portion of operating lease liability | 3,535 | 3,446 | ||||||
| Current portion of finance lease obligation | 537 | 835 | ||||||
| Total current liabilities | 32,828 | 59,459 | ||||||
| Long-term debt, less current portion | 233,313 | 145,059 | ||||||
| Derivative liabilities | 13,515 | — | ||||||
| Operating lease liability, less current portion | 28,753 | 20,907 | ||||||
| Finance lease obligation, less current portion | 388 | 445 | ||||||
| Deferred income taxes | 1,988 | 1,152 | ||||||
| Defined benefit pension plan obligation | 4,777 | 6,896 | ||||||
| 22,525 | 21,475 | |||||||
| Total liabilities | 338,087 | 255,393 | ||||||
| Commitments and contingencies | ||||||||
| Shareholders' equity (deficit): | ||||||||
| Ordinary shares (nil par value) 102,611,397 and 101,264,412 issued and outstanding at March 31, 2022 and March 31, 2021 respectively | 540,736 | 540,813 | ||||||
| Additional paid in capital | 46,399 | 38,116 | ||||||
| Accumulated other comprehensive loss | (6,191 | ) | (14,598 | ) | ||||
| Accumulated deficit | (725,042 | ) | (599,912 | ) | ||||
| Total shareholders' equity (deficit) | (144,098 | ) | (35,581 | ) | ||||
| Total liabilities and shareholders' equity (deficit) | $ | 193,989 | $ | 219,812 | ||||
| Quotient Limited Condensed Consolidated Statements of Cash Flows (In thousands) | |||||||||
| Year ended March 31, | |||||||||
| 2022 | 2021 | ||||||||
| OPERATING ACTIVITIES: | |||||||||
| Net loss | $ | (125,130 | ) | $ | (111,032 | ) | |||
| Adjustments to reconcile net loss to net cash provided by operating activities operating activities: | |||||||||
| Depreciation, amortization and loss on disposal of fixed assets | 7,417 | 8,354 | |||||||
| Share-based compensation | 6,156 | 4,984 | |||||||
| Increase in deferred lease rentals | 659 | 726 | |||||||
| Swiss pension obligation | 669 | 1,054 | |||||||
| Amortization of deferred debt issue costs and discount | 11,020 | 12,965 | |||||||
| Impairment of investments | 970 | 2,285 | |||||||
| Change in fair value of derivative instruments | (19,395 | ) | — | ||||||
| Accrued preference share dividends | 1,050 | 1,050 | |||||||
| Provision for income taxes | 961 | 1,254 | |||||||
| Net change in assets and liabilities: | |||||||||
| Trade accounts receivable, net | (1,143 | ) | 568 | ||||||
| Inventories | (165 | ) | (475 | ) | |||||
| Accounts payable and accrued liabilities | 3,418 | (3,410 | ) | ||||||
| Accrued compensation and benefits | (3,735 | ) | 4,549 | ||||||
| Other assets | (1,796 | ) | (454 | ) | |||||
| Net cash used in operating activities | (119,044 | ) | (77,582 | ) | |||||
| INVESTING ACTIVITIES: | |||||||||
| Increase in short-term investments | (4,500 | ) | (87,247 | ) | |||||
| Realization of short-term investments | 51,425 | 134,936 | |||||||
| Purchase of property and equipment | (2,851 | ) | (4,240 | ) | |||||
| Purchase of intangible assets | — | — | |||||||
| Net cash from investing activities | 44,074 | 43,449 | |||||||
| FINANCING ACTIVITIES: | |||||||||
| Repayment of finance leases | (713 | ) | (633 | ) | |||||
| Proceeds from issuance of long-term debt | 104,222 | — | |||||||
| Debt issuance costs | (3,732 | ) | — | ||||||
| Repayment of long-term debt | (12,083 | ) | — | ||||||
| (Cost of) proceeds from issuance of ordinary shares and warrants | (76 | ) | 80,881 | ||||||
| Net cash generated from financing activities | 87,618 | 80,248 | |||||||
| Effect of exchange rate fluctuations on cash and cash equivalents | 6,458 | (4,358 | ) | ||||||
| Change in cash and cash equivalents | 19,106 | 41,757 | |||||||
| Beginning cash and cash equivalents | 54,697 | 12,940 | |||||||
| Ending cash and cash equivalents | $ | 73,803 | $ | 54,697 | |||||
| Supplemental cash flow disclosures: | |||||||||
| Income taxes paid | $ | — | $ | — | |||||
| Interest paid | $ | 19,008 | $ | 17,529 | |||||
| Reconciliation of cash, cash equivalents and restricted cash: | $ | — | |||||||
| Cash and cash equivalents | $ | 65,059 | $ | 45,673 | |||||
| Restricted cash | $ | 8,744 | $ | 9,024 | |||||
| Total cash, cash equivalents and restricted cash | $ | 73,803 | $ | 54,697 | |||||
FAQ
What were Quotient Limited's revenue results for FY 2022?
What is the financial outlook for Quotient Limited in FY 2023?
What recent orders did Quotient Limited secure for its MosaiQ solution?
What is the cash position of Quotient Limited as of March 31, 2022?
