UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended December 31, 20192020

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 001-36415

 

QUOTIENT LIMITED

(Exact name of registrant as specified in its charter)

 

 

Jersey, Channel Islands

 

Not Applicable

(State or other jurisdiction of
incorporation or organization)

 

(I.R.S. Employer
Identification No.)

 

 

B1, Business Park Terre Bonne,

Route de Crassier 13,

1262 Eysins, Switzerland

 

Not Applicable

(Address of principal executive offices)

 

(Zip Code)

011-41-22-716-9800

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol

 

Name of each exchange on which registered

Ordinary Shares, nil par value

 

QTNT

 

The Nasdaq Global Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes      No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes      No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

  

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

☐  

  

Smaller reporting company

 

 

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes      No  

As of January 31, 2020,February 2, 2021, there were 80,311,796101,133,253 Ordinary Shares, nil par value, of Quotient Limited outstanding.

 

 

 


 

TABLE OF CONTENTS

 

 

  

Page

 

PART I – FINANCIAL INFORMATION

  

 

3

 

 

Item 1. Financial Statements

  

 

3

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

  

 

2627

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

  

 

41

 

 

Item 4. Controls and Procedures

  

 

42

 

 

PART II – OTHER INFORMATION

  

 

43

 

 

Item 1. Legal Proceedings

  

 

43

 

 

Item 1A. Risk Factors

43

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

  

 

44

 

 

Item 3. Defaults Upon Senior2. Unregistered Sales of Equity Securities and Use of Proceeds

44

Item 4. Mine Safety Disclosures

44

Item 5. Other Information

44

Item 6. Exhibits

  

 

45

 

 

SignaturesItem 3. Defaults Upon Senior Securities

45

Item 4. Mine Safety Disclosures

45

Item 5. Other Information

  

 

46

Item 6. Exhibits

47

Signatures

48

 

 

 

 

- i -


 

Cautionary note regarding forward-looking statements

This Quarterly Report on Form 10-Q, and exhibits thereto, contains estimates, predictions, opinions, projections and other statements that may be interpreted as “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, that involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I, Item 2: “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and are also contained elsewhere in this Quarterly Report. Forward-looking statements can be identified by words such as “strategy,” “objective,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “contemplate,” “might,” “design” and other similar expressions, although not all forward-looking statements contain these identifying words. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain, and are subject to numerous known and unknown risks and uncertainties.

Forward-looking statements include statements about:

 

the continuing development, regulatory approval and commercialization of the MosaiQTM technology, or “MosaiQ”;

the design of blood grouping and disease screening capabilities of MosaiQ, the potential for the expansion of our MosaiQ technology into the larger clinical diagnostics market and the benefits of MosaiQ for both customers and patients;

the design of blood grouping and disease screening capabilities of MosaiQ, the potential for the expansion of MosaiQ into the larger clinical diagnostics market and the benefits of MosaiQ for both customers and patients (including using MosaiQ  to test for novel coronavirus disease 2019, or COVID-19, antibodies);

future demand for and customer adoption of MosaiQ, the factors that we believe will drive such demand and our ability to address such demand;

future demand for and customer adoption of MosaiQ, the factors that we believe will drive such demand and our ability to address such demand;

our expected profit margins for MosaiQ;

our expected profit margins for MosaiQ;

the size of the market for MosaiQ;

the size of the market for MosaiQ;

the regulation of MosaiQ by the U.S. Food and Drug Administration, or the FDA, or other regulatory bodies, or any unanticipated regulatory changes or scrutiny by such regulators;

the regulation of MosaiQ by the U.S. Food and Drug Administration, or the FDA, or other regulatory bodies, or any unanticipated regulatory changes or scrutiny by such regulators;

future plans for our conventional reagent products;

future plans for our conventional reagent products;

the status of our future relationships with customers, suppliers, and regulators relating to our products;

the status of our future relationships with customers, suppliers, and regulators relating to our products;

future demand for our conventional reagent products and our ability to meet such demand;

future demand for our conventional reagent products and our ability to meet such demand;

our ability to manage the risks associated with international operations;

our ability to manage the risks associated with international operations;

anticipated changes, trends and challenges in our business and the transfusion diagnostics market;

anticipated changes, trends and challenges in our business and the transfusion diagnostics market;

the effects of competition;

continued or worsening adverse conditions in the global economic and financial markets, including as a result of the on-going COVID-19 pandemic;

the expected outcome or impact of pending or threatened arbitration or litigation, including our ongoing dispute with Ortho-Clinical Diagnostics Inc., or Ortho;

the impact on our business of the United Kingdom ceasing to be a member of the European Union;

our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

the effects of competition;

the status of our business relationship with Ortho;

the expected outcome or impact of arbitration or litigation;

our anticipated cash needs, including the adequacy of our available cash and short-term investment balances relative to our forecasted cash requirements for the next twelve months, our expected sources of funding, and our estimates regarding our capital requirements and capital expenditures; and

our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

our anticipated cash needs, including the adequacy of our available cash and short-term investment balances relative to our forecasted cash requirements for the next twelve months, our expected sources of funding, and our estimates regarding our capital requirements and capital expenditures; and

our plans for executive and director compensation for the future.

our plans for executive and director compensation for the future.- 1 -


You should also refer to the various factors identified in this and other reports filed by us with the Securities and Exchange Commission, or SEC, including but not limited to those discussed in the section entitled “Risk Factors” in this Quarterly Report and in our Annual Report on Form 10-K for the year ended March 31, 2019 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019,2020, for a discussion of other important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Further, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this Quarterly Report represent our views only as of the date of this Quarterly Report. Subsequent events and developments may cause our views to change. While we may elect to update these forward-looking statements at some point in the future, we undertake no obligation to publicly update any forward-looking statements, except as required by law.

- 1 -


You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report.

Available Information

Access to our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to these reports filed with or furnished to the SEC, may be obtained through the investor section of our website at www.quotientbd.com as soon as reasonably practical after we electronically file or furnish these reports. We do not charge for access to and viewing of these reports. Information on our website, including in the investor section, is not part of this Quarterly Report on Form 10-Q or any of our other securities filings unless specifically incorporated herein or therein by reference. In addition, our filings with the SEC may be accessed through the SEC’s website at www.sec.gov. All statements made in any of our securities filings, including all forward-looking statements or information, are made as of the date of the document in which the statement is included, and we do not assume or undertake any obligation to update any of those statements or documents unless we are required to do so by law.

 

 

- 2 -


 

PART I – FINANCIALFINANCIAL INFORMATION

Item 1. Financial Statements

CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

(Expressed in thousands of U.S. Dollars — except for share data and per share data)

 

 

 

December 31,

2019

 

 

March 31,

2019

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

4,664

 

 

$

4,096

 

Short-term investments

 

 

133,371

 

 

 

90,729

 

Trade accounts receivable, net

 

 

5,037

 

 

 

3,348

 

Inventories

 

 

19,791

 

 

 

15,551

 

Prepaid expenses and other current assets

 

 

3,856

 

 

 

3,202

 

Total current assets

 

 

166,719

 

 

 

116,926

 

Restricted cash

 

 

9,015

 

 

 

7,507

 

Property and equipment, net

 

 

43,425

 

 

 

47,293

 

Operating lease right-of-use assets

 

 

22,798

 

 

 

 

Intangible assets, net

 

 

687

 

 

 

751

 

Deferred income taxes

 

 

564

 

 

 

605

 

Other non-current assets

 

 

4,747

 

 

 

4,688

 

Total assets

 

$

247,955

 

 

$

177,770

 

LIABILITIES AND SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,513

 

 

$

5,936

 

Accrued compensation and benefits

 

 

5,899

 

 

 

6,149

 

Accrued expenses and other current liabilities

 

 

12,839

 

 

 

12,458

 

Current portion of operating lease liability

 

 

3,157

 

 

 

 

Current portion of deferred lease rental benefit

 

 

 

 

 

435

 

Current portion of finance lease obligation

 

 

522

 

 

 

471

 

Total current liabilities

 

 

25,930

 

 

 

25,449

 

Long-term debt, less current portion

 

 

153,717

 

 

 

121,855

 

Operating lease liability, less current portion

 

 

21,139

 

 

 

 

Deferred lease rental benefit, less current portion

 

 

 

 

 

1,144

 

Finance lease obligation, less current portion

 

 

950

 

 

 

865

 

Defined benefit pension plan obligation

 

 

7,998

 

 

 

7,368

 

7% Cumulative redeemable preference shares

 

 

20,163

 

 

 

19,375

 

Total liabilities

 

 

229,897

 

 

 

176,056

 

Commitments and contingencies

 

 

 

 

 

 

Shareholders' equity:

 

 

 

 

 

 

 

 

Ordinary shares (nil par value) 80,256,946 and 65,900,447 issued and outstanding at

December 31, 2019 and March 31, 2019 respectively

 

 

459,686

 

 

 

368,958

 

Additional paid in capital

 

 

32,040

 

 

 

28,665

 

Accumulated other comprehensive loss

 

 

(14,960

)

 

 

(14,884

)

Accumulated deficit

 

 

(458,708

)

 

 

(381,025

)

Total shareholders' equity

 

 

18,058

 

 

 

1,714

 

Total liabilities and shareholders' equity

 

$

247,955

 

 

$

177,770

 

 

 

 

December 31,

2020

 

 

March 31,

2020

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

3,401

 

 

$

3,923

 

Short-term investments

 

 

131,062

 

 

 

116,871

 

Trade accounts receivable, net

 

 

4,539

 

 

 

5,402

 

Inventories

 

 

23,709

 

 

 

20,501

 

Prepaid expenses and other current assets

 

 

4,928

 

 

 

3,775

 

Total current assets

 

 

167,639

 

 

 

150,472

 

Restricted cash

 

 

9,046

 

 

 

9,017

 

Property and equipment, net

 

 

40,894

 

 

 

40,165

 

Operating lease right-of-use assets

 

 

22,364

 

 

 

21,493

 

Intangible assets, net

 

 

632

 

 

 

625

 

Deferred income taxes

 

 

237

 

 

 

237

 

Other non-current assets

 

 

4,914

 

 

 

4,454

 

Total assets

 

$

245,726

 

 

$

226,463

 

LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

5,860

 

 

$

4,826

 

Accrued compensation and benefits

 

 

4,844

 

 

 

7,210

 

Accrued expenses and other current liabilities

 

 

11,351

 

 

 

15,490

 

Current portion of long-term debt

 

 

24,167

 

 

 

 

Current portion of operating lease liability

 

 

3,309

 

 

 

3,033

 

Current portion of finance lease obligation

 

 

878

 

 

 

598

 

Total current liabilities

 

 

50,409

 

 

 

31,157

 

Long-term debt, less current portion

 

 

135,490

 

 

 

153,024

 

Operating lease liability, less current portion

 

 

21,203

 

 

 

19,914

 

Finance lease obligation, less current portion

 

 

582

 

 

 

1,117

 

Deferred income taxes

 

 

1,455

 

 

 

 

Defined benefit pension plan obligation

 

 

7,707

 

 

 

6,353

 

7% Cumulative redeemable preference shares

 

 

21,213

 

 

 

20,425

 

Total liabilities

 

 

238,059

 

 

 

231,990

 

Commitments and contingencies

 

 

 

 

 

 

Shareholders' equity (deficit):

 

 

 

 

 

 

 

 

Ordinary shares (nil par value) 101,075,845 and 80,398,326 issued and outstanding at December 31, 2020 and March 31, 2020 respectively

 

 

540,819

 

 

 

459,931

 

Additional paid in capital

 

 

36,630

 

 

 

33,132

 

Accumulated other comprehensive loss

 

 

(16,186

)

 

 

(15,155

)

Accumulated deficit

 

 

(553,596

)

 

 

(483,435

)

Total shareholders' equity (deficit)

 

 

7,667

 

 

 

(5,527

)

Total liabilities and shareholders' equity (deficit)

 

$

245,726

 

 

$

226,463

 

 

The accompanying notes form an integral part of these condensed consolidated financial statements.

 

- 3 -


 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited)

(Expressed in thousands of U.S. Dollars — except for share data and per share data)

 

 

 

Quarter ended

 

 

Nine months ended

 

 

Quarter ended

 

 

Nine months ended

 

 

December 31,

 

 

December 31,

 

 

December 31,

 

 

December 31,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

7,636

 

 

$

6,723

 

 

$

22,901

 

 

$

20,834

 

 

$

8,740

 

 

$

7,636

 

 

$

26,207

 

 

$

22,901

 

Other revenues

 

 

305

 

 

 

 

 

 

1,055

 

 

 

19

 

 

 

11

 

 

 

305

 

 

 

7,534

 

 

 

1,055

 

Total revenue

 

 

7,941

 

 

 

6,723

 

 

 

23,956

 

 

 

20,853

 

 

 

8,751

 

 

 

7,941

 

 

 

33,741

 

 

 

23,956

 

Cost of revenue

 

 

(4,532

)

 

 

(4,186

)

 

 

(13,067

)

 

 

(12,803

)

 

 

(4,970

)

 

 

(4,532

)

 

 

(14,883

)

 

 

(13,067

)

Gross profit

 

 

3,409

 

 

 

2,537

 

 

 

10,889

 

 

 

8,050

 

 

 

3,781

 

 

 

3,409

 

 

 

18,858

 

 

 

10,889

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

(2,290

)

 

 

(2,233

)

 

 

(7,123

)

 

 

(6,359

)

 

 

(2,283

)

 

 

(2,290

)

 

 

(6,757

)

 

 

(7,123

)

Research and development, net of government grants

 

 

(14,160

)

 

 

(11,788

)

 

 

(38,895

)

 

 

(37,356

)

 

 

(14,485

)

 

 

(14,160

)

 

 

(38,813

)

 

 

(38,895

)

General and administrative expense:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Compensation expense in respect of share options and

management equity incentives

 

 

(1,196

)

 

 

(1,073

)

 

 

(3,375

)

 

 

(3,576

)

 

 

(1,214

)

 

 

(1,196

)

 

 

(3,498

)

 

 

(3,375

)

Other general and administrative expenses

 

 

(8,120

)

 

 

(6,471

)

 

 

(20,717

)

 

 

(19,388

)

 

 

(7,524

)

 

 

(8,120

)

 

 

(24,334

)

 

 

(20,717

)

Total general and administrative expense

 

 

(9,316

)

 

 

(7,544

)

 

 

(24,092

)

 

 

(22,964

)

 

 

(8,738

)

 

 

(9,316

)

 

 

(27,832

)

 

 

(24,092

)

Total operating expense

 

 

(25,766

)

 

 

(21,565

)

 

 

(70,110

)

 

 

(66,679

)

 

 

(25,506

)

 

 

(25,766

)

 

 

(73,402

)

 

 

(70,110

)

Operating loss

 

 

(22,357

)

 

 

(19,028

)

 

 

(59,221

)

 

 

(58,629

)

 

 

(21,725

)

 

 

(22,357

)

 

 

(54,544

)

 

 

(59,221

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(7,008

)

 

 

(5,679

)

 

 

(20,384

)

 

 

(14,614

)

 

 

(6,753

)

 

 

(7,008

)

 

 

(19,537

)

 

 

(20,384

)

Other, net

 

 

1,894

 

 

 

(1,536

)

 

 

1,600

 

 

 

(5,516

)

 

 

192

 

 

 

1,894

 

 

 

5,423

 

 

 

1,600

 

Other expense, net

 

 

(5,114

)

 

 

(7,215

)

 

 

(18,784

)

 

 

(20,130

)

 

 

(6,561

)

 

 

(5,114

)

 

 

(14,114

)

 

 

(18,784

)

Loss before income taxes

 

 

(27,471

)

 

 

(26,243

)

 

 

(78,005

)

 

 

(78,759

)

 

 

(28,286

)

 

 

(27,471

)

 

 

(68,658

)

 

 

(78,005

)

Provision for income taxes

 

 

(14

)

 

 

(11

)

 

 

(41

)

 

 

(33

)

 

 

(1,471

)

 

 

(14

)

 

 

(1,503

)

 

 

(41

)

Net loss

 

$

(27,485

)

 

$

(26,254

)

 

$

(78,046

)

 

$

(78,792

)

 

$

(29,757

)

 

$

(27,485

)

 

$

(70,161

)

 

$

(78,046

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of foreign currency

cash flow hedges

 

$

487

 

 

$

41

 

 

$

209

 

 

$

(320

)

 

$

295

 

 

$

487

 

 

$

571

 

 

$

209

 

Change in unrealized gain on short-term investments

 

 

148

 

 

 

169

 

 

 

342

 

 

 

416

 

 

 

111

 

 

 

148

 

 

 

(372

)

 

 

342

 

Foreign currency gain (loss)

 

 

254

 

 

 

(176

)

 

 

(771

)

 

 

554

 

 

 

2,031

 

 

 

254

 

 

 

(1,270

)

 

 

(771

)

Provision for pension benefit obligation

 

 

48

 

 

 

35

 

 

 

144

 

 

 

107

 

 

 

13

 

 

 

48

 

 

 

40

 

 

 

144

 

Other comprehensive income (loss), net

 

 

937

 

 

 

69

 

 

 

(76

)

 

 

757

 

Other comprehensive loss, net

 

 

2,450

 

 

 

937

 

 

 

(1,031

)

 

 

(76

)

Comprehensive loss

 

$

(26,548

)

 

$

(26,185

)

 

$

(78,122

)

 

$

(78,035

)

 

$

(27,307

)

 

$

(26,548

)

 

$

(71,192

)

 

$

(78,122

)

Net loss available to ordinary shareholders - basic and diluted

 

$

(27,485

)

 

$

(26,254

)

 

$

(78,046

)

 

$

(78,792

)

 

$

(29,757

)

 

$

(27,485

)

 

$

(70,161

)

 

$

(78,046

)

Loss per share - basic and diluted

 

$

(0.37

)

 

$

(0.46

)

 

$

(1.14

)

 

$

(1.53

)

 

$

(0.29

)

 

$

(0.37

)

 

$

(0.79

)

 

$

(1.14

)

Weighted-average shares outstanding - basic and diluted

 

 

73,768,845

 

 

 

56,619,356

 

 

 

68,722,475

 

 

 

51,512,352

 

 

 

101,016,040

 

 

 

73,768,845

 

 

 

88,512,823

 

 

 

68,722,475

 

 

The accompanying notes form an integral part of these condensed consolidated financial statements.

 

 

- 4 -


 

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT) (unaudited)

(Expressed in thousands of U.S. Dollars — except for share data)

 

 

 

Ordinary shares

 

 

Additional paid in

 

 

Accumulated

Other Comprehensive

 

 

Accumulated

 

 

Total Shareholders'

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

Loss

 

 

Deficit

 

 

Equity (Deficit)

 

September 30, 2020

 

 

100,965,451

 

 

$

540,769

 

 

$

35,416

 

 

$

(18,636

)

 

$

(523,839

)

 

$

33,710

 

Issue of shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issue of shares upon exercise of incentive share options and vesting of RSUs

 

 

110,394

 

 

 

50

 

 

 

 

 

 

 

 

 

 

 

 

50

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(29,757

)

 

 

(29,757

)

Change in the fair value of foreign currency cash flow hedges

 

 

 

 

 

 

 

 

 

 

 

295

 

 

 

 

 

 

295

 

Change in unrealized gain on short-term investments

 

 

 

 

 

 

 

 

 

 

 

111

 

 

 

 

 

 

111

 

Foreign currency gain (loss) on:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term investment nature intra-entity balances

 

 

 

 

 

 

 

 

 

 

 

(4,692

)

 

 

 

 

 

(4,692

)

Retranslation of foreign entities

 

 

 

 

 

 

 

 

 

 

 

6,723

 

 

 

 

 

 

6,723

 

Provision for pension benefit obligation

 

 

 

 

 

 

 

 

 

 

 

13

 

 

 

 

 

 

13

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

2,450

 

 

 

 

 

 

2,450

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,214

 

 

 

 

 

 

 

 

 

1,214

 

December 31, 2020

 

 

101,075,845

 

 

$

540,819

 

 

$

36,630

 

 

$

(16,186

)

 

$

(553,596

)

 

$

7,667

 

 

 

Ordinary shares

 

 

Additional paid in

 

 

Accumulated

Other Comprehensive

 

 

Accumulated

 

 

Total Shareholders'

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

Loss

 

 

Deficit

 

 

Equity (Deficit)

 

March 31, 2020

 

 

80,398,326

 

 

$

459,931

 

 

$

33,132

 

 

$

(15,155

)

 

$

(483,435

)

 

$

(5,527

)

Issue of shares, net of issue costs of $5,565

 

 

20,294,117

 

 

 

80,685

 

 

 

 

 

 

 

 

 

 

 

 

80,685

 

Issue of shares upon exercise of incentive share options and vesting of RSUs

 

 

383,402

 

 

 

203

 

 

 

 

 

 

 

 

 

 

 

 

203

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(70,161

)

 

 

(70,161

)

Change in the fair value of foreign currency cash flow hedges

 

 

 

 

 

 

 

 

 

 

 

571

 

 

 

 

 

 

571

 

Change in unrealized gain on short-term investments

 

 

 

 

 

 

 

 

 

 

 

(372

)

 

 

 

 

 

(372

)

Foreign currency gain (loss) on:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term investment nature intra-entity balances

 

 

 

 

 

 

 

 

 

 

 

(3,848

)

 

 

 

 

 

(3,848

)

Retranslation of foreign entities

 

 

 

 

 

 

 

 

 

 

 

2,578

 

 

 

 

 

 

2,578

 

Provision for pension benefit obligation

 

 

 

 

 

 

 

 

 

 

 

40

 

 

 

 

 

 

40

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(1,031

)

 

 

 

 

 

(1,031

)

Stock-based compensation

 

 

 

 

 

 

 

 

3,498

 

 

 

 

 

 

 

 

 

3,498

 

December 31, 2020

 

 

101,075,845

 

 

$

540,819

 

 

$

36,630

 

 

$

(16,186

)

 

$

(553,596

)

 

$

7,667

 

The accompanying notes form an integral part of these condensed consolidated financial statements.

- 5 -


 

 

Ordinary shares

 

 

Additional paid in

 

 

Accumulated

Other Comprehensive

 

 

Accumulated

 

 

Total Shareholders'

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

Loss

 

 

Deficit

 

 

Equity (Deficit)

 

September 30, 2019

 

 

66,366,706

 

 

$

369,335

 

 

$

30,844

 

 

$

(15,897

)

 

$

(431,223

)

 

$

(46,941

)

Issue of shares, net of issue costs of $6,227

 

 

13,800,000

 

 

$

90,373

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

90,373

 

Issue of shares upon exercise of

   incentive share options and

   vesting of RSUs

 

 

90,240

 

 

 

(22

)

 

 

 

 

 

 

 

 

 

 

 

(22

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(27,485

)

 

 

(27,485

)

Change in the fair value of foreign

   currency cash flow hedges

 

 

 

 

 

 

 

 

 

 

 

487

 

 

 

 

 

 

487

 

Change in unrealized gain on short-

   term investments

 

 

 

 

 

 

 

 

 

 

 

148

 

 

 

 

 

 

148

 

Foreign currency gain (loss) on:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term investment nature

   intra-entity balances

 

 

 

 

 

 

 

 

 

 

 

(7,435

)

 

 

 

 

 

(7,435

)

Retranslation of foreign entities

 

 

 

 

 

 

 

 

 

 

 

7,689

 

 

 

 

 

 

7,689

 

Provision for pension benefit

   obligation

 

 

 

 

 

 

 

 

 

 

 

48

 

 

 

 

 

 

48

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

937

 

 

 

 

 

 

937

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,196

 

 

 

 

 

 

 

 

 

1,196

 

December 31, 2019

 

 

80,256,946

 

 

$

459,686

 

 

$

32,040

 

 

$

(14,960

)

 

$

(458,708

)

 

$

18,058

 

 

 

 

Ordinary shares

 

 

Additional paid in

 

 

Accumulated

Other Comprehensive

 

 

Accumulated

 

 

Total Shareholders'

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

Loss

 

 

Deficit

 

 

Equity (Deficit)

 

March 31, 2019

 

 

65,900,447

 

 

$

368,958

 

 

$

28,665

 

 

$

(14,884

)

 

$

(381,025

)

 

$

1,714

 

Issue of shares, net of issue costs of $6,227

 

 

13,800,000

 

 

 

90,373

 

 

 

 

 

 

 

 

 

 

 

 

90,373

 

Issue of shares upon exercise of

   incentive share options and

   vesting of RSUs

 

 

556,499

 

 

 

355

 

 

 

 

 

 

 

 

 

 

 

 

355

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(78,046

)

 

 

(78,046

)

Change in the fair value of foreign

   currency cash flow hedges

 

 

 

 

 

 

 

 

 

 

 

209

 

 

 

 

 

 

209

 

Change in unrealized gain on short-

   term investments

 

 

 

 

 

 

 

 

 

 

 

342

 

 

 

 

 

 

342

 

Foreign currency gain (loss) on:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term investment nature

   intra-entity balances

 

 

 

 

 

 

 

 

 

 

 

2,972

 

 

 

 

 

 

2,972

 

Retranslation of foreign entities

 

 

 

 

 

 

 

 

 

 

 

(3,743

)

 

 

 

 

 

(3,743

)

Provision for pension benefit

   obligation

 

 

 

 

 

 

 

 

 

 

 

144

 

 

 

 

 

 

144

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(76

)

 

 

 

 

 

(76

)

Stock-based compensation

 

 

 

 

 

 

 

 

3,375

 

 

 

 

 

 

 

 

 

3,375

 

Cumulative effect of accounting

   changes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

363

 

 

 

363

 

December 31, 2019

 

 

80,256,946

 

 

$

459,686

 

 

$

32,040

 

 

$

(14,960

)

 

$

(458,708

)

 

$

18,058

 

 

The accompanying notes form an integral part of these consolidated financial statements.


- 5 -


CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIT) (unaudited)

(Expressed in thousands of U.S. Dollars — except for share data)

 

 

Ordinary shares

 

 

Additional paid in

 

 

Accumulated

Other Comprehensive

 

 

Accumulated

 

 

Total Shareholders'

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

Loss

 

 

Deficit

 

 

Equity (Deficit)

 

September 30, 2018

 

 

54,229,503

 

 

$

303,176

 

 

$

26,211

 

 

$

(15,946

)

 

$

(328,177

)

 

$

(14,736

)

Issue of shares, net of issue costs of $4,497

 

 

10,615,385

 

 

 

64,503

 

 

 

 

 

 

 

 

 

 

 

 

64,503

 

Issue of shares upon exercise of incentive

   share options and vesting of RSUs

 

 

127,664

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(26,254

)

 

 

(26,254

)

Change in the fair value of the effective

   portion of foreign currency cash

   flow hedges

 

 

 

 

 

 

 

 

 

 

 

41

 

 

 

 

 

 

41

 

Unrealized gain on short-term investments

 

 

 

 

 

 

 

 

 

 

 

169

 

 

 

 

 

 

169

 

Foreign currency gain (loss) on:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term investment nature intra-

   entity balances

 

 

 

 

 

 

 

 

 

 

 

3,399

 

 

 

 

 

 

3,399

 

Retranslation of foreign entities

 

 

 

 

 

 

 

 

 

 

 

(3,575

)

 

 

 

 

 

(3,575

)

Provision for pension benefit obligation

 

 

 

 

 

 

 

 

 

 

 

35

 

 

 

 

 

 

35

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

69

 

 

 

 

 

 

69

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,073

 

 

 

 

 

 

 

 

 

1,073

 

December 31, 2018

 

 

64,972,552

 

 

$

367,679

 

 

$

27,284

 

 

$

(15,877

)

 

$

(354,431

)

 

$

24,655

 

 

 

Ordinary shares

 

 

Additional paid in

 

 

Accumulated

Other Comprehensive

 

 

Accumulated

 

 

Total Shareholders'

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

Loss

 

 

Deficit

 

 

Equity (Deficit)

 

March 31, 2018

 

 

45,646,424

 

 

$

253,934

 

 

$

23,708

 

 

$

(16,634

)

 

$

(275,639

)

 

$

(14,631

)

Issue of shares, net of issue costs of $4,497

 

 

19,085,068

 

 

 

113,723

 

 

 

 

 

 

 

 

 

 

 

 

113,723

 

Issue of shares upon exercise of incentive

   share options and vesting of RSUs

 

 

241,060

 

 

 

22

 

 

 

 

 

 

 

 

 

 

 

 

22

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(78,792

)

 

 

(78,792

)

Change in the fair value of the effective

   portion of foreign currency cash

   flow hedges

 

 

 

 

 

 

 

 

 

 

 

(320

)

 

 

 

 

 

(320

)

Unrealized gain on short-term investments

 

 

 

 

 

 

 

 

 

 

 

416

 

 

 

 

 

 

416

 

Foreign currency gain (loss) on:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term investment nature intra-

   entity balances

 

 

 

 

 

 

 

 

 

 

 

10,848

 

 

 

 

 

 

10,848

 

Retranslation of foreign entities

 

 

 

 

 

 

 

 

 

 

 

(10,294

)

 

 

 

 

 

(10,294

)

Provision for pension benefit obligation

 

 

 

 

 

 

 

 

 

 

 

107

 

 

 

 

 

 

107

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

757

 

 

 

 

 

 

757

 

Stock-based compensation

 

 

 

 

 

 

 

 

3,576

 

 

 

 

 

 

 

 

 

3,576

 

December 31, 2018

 

 

64,972,552

 

 

$

367,679

 

 

$

27,284

 

 

$

(15,877

)

 

$

(354,431

)

 

$

24,655

 

The accompanying notes form an integral part of thesecondensed consolidated financial statements.

 

 

- 6 -


 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)

(Expressed in thousands of U.S. Dollars)

 

 

Nine months ended

December 31,

 

 

Nine months ended

December 31,

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(78,046

)

 

$

(78,792

)

 

$

(70,161

)

 

$

(78,046

)

Adjustments to reconcile net loss to net cash provided by operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

8,996

 

 

 

9,503

 

Depreciation, amortization and loss on disposal of fixed assets

 

 

6,484

 

 

 

8,996

 

Share-based compensation

 

 

3,375

 

 

 

3,576

 

 

 

3,498

 

 

 

3,375

 

Increase in deferred lease rentals

 

 

215

 

 

 

266

 

 

 

512

 

 

 

215

 

Swiss pension obligation

 

 

551

 

 

 

453

 

 

 

776

 

 

 

551

 

Amortization of deferred debt issue costs

 

 

7,736

 

 

 

4,097

 

 

 

6,633

 

 

 

7,736

 

Accrued preference share dividends

 

 

788

 

 

 

788

 

 

 

788

 

 

 

788

 

Deferred income taxes

 

 

41

 

 

 

33

 

Income taxes

 

 

1,503

 

 

 

41

 

Net change in assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Trade accounts receivable, net

 

 

(1,638

)

 

 

315

 

 

 

1,268

 

 

 

(1,638

)

Inventories

 

 

(3,838

)

 

 

147

 

 

 

(1,218

)

 

 

(3,838

)

Accounts payable and accrued liabilities

 

 

(2,268

)

 

 

(5,076

)

 

 

(3,670

)

 

 

(2,268

)

Accrued compensation and benefits

 

 

(268

)

 

 

(664

)

 

 

(2,825

)

 

 

(268

)

Other assets

 

 

(406

)

 

 

3,833

 

 

 

(330

)

 

 

(406

)

Net cash used in operating activities

 

 

(64,762

)

 

 

(61,521

)

 

 

(56,742

)

 

 

(64,762

)

INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Increase in short-term investments

 

 

(95,000

)

 

 

(119,000

)

 

 

(72,247

)

 

 

(95,000

)

Realization of short-term investments

 

 

52,700

 

 

 

21,883

 

 

 

57,683

 

 

 

52,700

 

Purchase of property and equipment

 

 

(3,941

)

 

 

(3,047

)

 

 

(3,602

)

 

 

(3,941

)

Purchase of intangible assets

 

 

 

 

 

(3

)

Net cash used in investing activities

 

 

(46,241

)

 

 

(100,167

)

 

 

(18,166

)

 

 

(46,241

)

FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Repayment of finance leases

 

 

(337

)

 

 

(358

)

 

 

(491

)

 

 

(337

)

Proceeds from drawdown of new debt

 

 

25,000

 

 

 

36,000

 

 

 

 

 

 

25,000

 

Debt issuance costs and fees paid to noteholders

 

 

(874

)

 

 

(5,113

)

 

 

 

 

 

(874

)

Proceeds from issuance of ordinary shares and warrants

 

 

90,728

 

 

 

113,745

 

 

 

80,888

 

 

 

90,728

 

Net cash generated from financing activities

 

 

114,517

 

 

 

144,274

 

 

 

80,397

 

 

 

114,517

 

Effect of exchange rate fluctuations on cash, cash equivalents and restricted cash

 

 

(1,438

)

 

 

4,187

 

 

 

(5,982

)

 

 

(1,438

)

Change in cash, cash equivalents and restricted cash

 

 

2,076

 

 

 

(13,227

)

 

 

(493

)

 

 

2,076

 

Beginning cash, cash equivalents and restricted cash

 

 

11,603

 

 

 

25,205

 

 

 

12,940

 

 

 

11,603

 

Ending cash, cash equivalents and restricted cash

 

$

13,679

 

 

$

11,978

 

 

$

12,447

 

 

$

13,679

 

Supplemental cash flow disclosures:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income taxes paid

 

$

 

 

$

 

 

$

 

 

$

 

Interest paid

 

$

15,959

 

 

$

11,435

 

 

$

17,499

 

 

$

15,959

 

Reconciliation of cash, cash equivalents and restricted cash:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

4,664

 

 

$

4,468

 

 

$

3,401

 

 

$

4,664

 

Restricted cash

 

 

9,015

 

 

 

7,510

 

 

 

9,046

 

 

 

9,015

 

Total cash, cash equivalents and restricted cash

 

$

13,679

 

 

$

11,978

 

 

$

12,447

 

 

$

13,679

 

 

The accompanying notes form an integral part of these condensed consolidated financial statements.

 

- 7 -


 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Expressed in thousands of U.S. Dollars — except for share data and per share data, unless otherwise stated)

 

Note 1. Description of Business and Basis of Presentation

Description of Business

The principal activity of Quotient Limited (the “Company”) and its subsidiaries (the “Group”) is the development, manufacture and sale of products for the global transfusion diagnostics market. Products manufactured by the Group are sold to hospitals, blood banking operations and other diagnostics companies worldwide.

Basis of Presentation

The condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and are unaudited. In accordance with those rules and regulations, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States (“GAAP”) for complete financial statements.

In the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) considered necessary to present fairly the financial position, results of operations, changes in shareholders’ equity and cash flows for the interim periods presented. The March 31, 20192020 balance sheet was derived from audited financial statements, but does not include all disclosures required by GAAP. However, the Company believes that the disclosures are adequate to make the information presented not misleading. The financial statements should be read in conjunction with the audited consolidated financial statements at and for the year ended March 31, 20192020 included in the Company’s Annual Report on Form 10-K for the year then ended. The results of operations for the nine month period ended December 31, 20192020 are not necessarily indicative of the results of operations that may be expected for the year ending March 31, 20202021 and any future period.

The Company has incurred net losses and negative cash flows from operations in each year since it commenced operations in 2007 and had an accumulated deficit of $458.7$553.6 million as of December 31, 2019.2020. At December 31, 20192020, the Company had available cash holdings and short-term investments of $138.0$134.5 million. The The Company’s existing available cash and short-term investment balances are adequate to meet its forecasted cash requirements for the next twelve months and accordingly the financial statements have been prepared on the going concern basis.  

In the longer term, the Company expects to fund its operations, including the ongoing development of MosaiQ through successful field trial completion, achievement of required regulatory authorizations and commercialization, from the use of existing available cash and short-term investment balances and the issuance of new equity or debt.

 

Note 2. Summary of Significant Accounting Policies

Use of Estimates

The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes.

On March 11, 2020, the World Health Organization declared the outbreak of a strain of novel coronavirus disease, COVID-19, a global pandemic. The extent to which the COVID-19 pandemic will impact the Company’s business, operations and financial results will depend on future developments and numerous evolving factors, which are highly uncertain and difficult to predict. As of the date of issuance of these unaudited condensed consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to further update estimates, judgments or revise the carrying value of any assets or liabilities. These estimates may change, as new events occur and additional information is obtained, and are recognized in the condensed consolidated financial statements as soon as they become known. Actual results could differ from these estimates.those estimates and any such differences may be material to the Company’s condensed consolidated financial statements.

- 8 -


Cash and Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. AllAt December 31, 2020 and March 31, 2020, all cash and cash equivalents comprised readily accessible cash balances. Restricted cash comprised $8.7 million and $7.2 million$8,700 at both December 31, 20192020 and March 31, 2019, respectively,2020, held in a cash reserve account pursuant to the indenture governing the Company’s 12% Senior Secured Notes (“the Secured Notes”) and $315$346 and $317 at December 31, 20192020 and $307 at March 31, 20192020, respectively, held in a restricted account as security for the property rental obligations of the Company’s Swiss subsidiary.

- 8 -


Short-term Investments

Short-term investments represent investments in a money-market fundfunds which isare valued daily and which hashave no minimum notice period for withdrawals. The fund isfunds are invested in a portfolio of holdings and the creditworthiness requirement for individual investment holdings is a minimum of an A rating from a leading credit-rating agency. The Company records the value of its investment in the fundfunds based on the quoted value of the fundfunds at the balance sheet date. Unrealized gains or losses are recorded in accumulated other comprehensive loss and are transferred to the statement of comprehensive loss when they are realized.

Trade Accounts Receivable

Trade accounts receivable are recorded at the invoiced amount and are not interest bearing. The Company maintains an allowance for doubtful accounts to reserve for potentially uncollectible trade receivables. Movements in the allowance for doubtful accounts are recorded in general and administrative expenses. The Company reviews its trade receivables to identify specific customers with known disputes or collectability issues. In addition, the Company maintains an allowance for all other receivables not included in the specific reserve by applying specific rates of projected uncollectible receivables to the various aging categories. In determining these percentages, the Company analyzes its historical collection experience, customer credit-worthiness, current and forecast economic trends and changes in customer payment terms.

Concentration of Credit Risks and Other Uncertainties

The carrying amounts for financial instruments consisting of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate fair value due to their short maturities. Derivative instruments, consisting of foreign exchange contracts, and short-term investments are stated at their estimated fair values, based on quoted market prices for the same or similar instruments. The counterparties to the foreign exchange contracts consist of large financial institutions of high credit standing. The short-term investments are invested in a fund which is invested in a portfolio of holdings and the creditworthiness requirement for individual investment holdings is a minimum of an A rating from a leading credit-rating agency.

The Company’s main financial institutions for banking operations holdheld all of the Company’s cash and cash equivalents as of December 31, 20192020 and at March 31, 2019.2020. The Company’s accounts receivable are derived from net revenue to customers and distributors located in the United States and other countries. The Company performs credit evaluations of its customers’ financial condition. The Company provides reserves for potential credit losses, but has not experienced significant losses to date. There was one1 customer whose accounts receivable balance represented 10% or more of total accounts receivable, net, as of December 31, 20192020 and March 31, 2019.2020. This customer represented 63%69% and 55%70% of the accounts receivable balances as of December 31, 20192020 and March 31, 2019,2020, respectively.

The Company currently sells products through its direct sales force and through third-party distributors. There was one1 customer that accounted for 10% or more of total product sales for the nine month periods ended December 31, 20192020 and December 31, 2018.2019. This customer represented 59% and 60% of total product sales for the nine month period ended December 31, 20192020 and 59% for the nine month period ended December 31, 2018.2019, respectively.

Fair Value of Financial Instruments

The Company defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company’s valuation techniques used to measure fair value maximized the use of observable inputs and minimized the use of unobservable inputs. The fair value hierarchy is based on the following three levels of inputs:

Level 1—Quoted prices in active markets for identical assets or liabilities.

Level 1—Quoted prices in active markets for identical assets or liabilities.

Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

- 9 -


Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

See Note 6, “Commitment and Contingencies,” for information and related disclosures regarding the Company’s fair value measurements.

- 9 -


Inventory

Inventory is stated at the lower of standard cost (which approximates actual cost) or market, withnet of reserves. Cost is determined at standard cost, determined on the first-in-first-out method. Accordingly, allocationapproximating average cost. Allocation of fixed production overheads to conversion costs is based on normal capacity of production. Abnormal amounts of idle facility expense, freight, handling costs and spoilage are expensed as incurred and not included in overhead. NoVariances between standard cost and actual cost, arising in the production process, are analyzed to determine whether they reflect part of the normal cost of production, and should therefore be reflected as inventory value, or whether they are a period cost and should thus not be included in inventory.  Inventory reserves are recorded based upon historic usage, expected future demand and shelf life of the products held in inventory. NaN stock-based compensation cost was included in inventory as of December 31, 20192020 and March 31, 2019.2020.

Property and Equipment

Property, equipment and leasehold improvements are stated at cost, net of accumulated depreciation and amortization. Depreciation and amortization are computed on a straight-line basis over the estimated useful lives of the related assets as follows:

Plant, machinery and equipment—4 to 20 years;

Plant, machinery and equipment—3 to 20 years;

Leasehold improvements—the shorter of the lease term or the estimated useful life of the asset.

Leasehold improvements—the shorter of the lease term or the estimated useful life of the asset.

Repairs and maintenance expenditures, which are not considered improvements and do not extend the useful life of property and equipment, are expensed as incurred.

Intangible Assets

Intangible assets related to product licenses are recorded at cost, less accumulated amortization. Intangible assets related to technology and other intangible assets acquired in acquisitions are recorded at fair value at the date of acquisition, less accumulated amortization. Intangible assets are amortized over their estimated useful lives, on a straight-line basis as follows:

Customer relationships—5 years

Brands associated with acquired cell lines—40 years

Product licenses—10 years

Other intangibles assets—7 years

The Company reviews its intangible assets for impairment and conducts an impairment review when events or circumstances indicate the carrying value of a long-lived asset may be impaired by estimating the future undiscounted cash flows to be derived from an asset to assess whether or not a potential impairment exists. NoNaN impairment losses have been recorded in either of the nine month periods ended December 31, 20192020 or December 31, 2018.2019.

Revenue Recognition

Revenue is recognized in accordance with ASU 2014-09, Revenue from Contracts with Customers.

Product revenue is recognized at a point in time upon transfer of control of a product to a customer, which is generally at the time of deliveryshipment at an amount based on the transaction price. Customers have no right of return except in the case of damaged goods and the Company has not experienced any significant returns of its products. Shipping and handling costs are expensed as incurred and included in cost of product sales. In those cases where the Company bills shipping and handling costs to customers, the amounts billed are classified as revenue.

- 10 -


Revenue is also earned from the provision of development services to a small number of original equipment manufacturer (“OEM”) customers. These development service contracts are reviewed individually to determine the nature of the performance obligations and the associated transaction prices.  In recent years, product development revenues have been commensurate with achieving milestones specified in the respective development agreements relating to those products. These milestones may include the approval of new products by the European or U.S. regulatory authorities, which are not within the Company’s control. While there can be no assurance that this will continue to be the case, the milestones have been such that they effectively represent completion of the Company’s performance obligations under a particular part of a development program. Should the Company fail to achieve these milestones the Company would not be entitled under the terms of the development agreements to any compensation for the work undertaken to date. As a result, the milestone-related revenues have been recognized as the contractual milestones are achieved.

- 10 -


Pursuant to an Umbrella Supply Agreement with Ortho,Ortho-Clinical Diagnostics, Inc. (“Ortho”), the Company executed a product attachment relating to the development of a range of rare antisera products. During the year ended March 31, 2019,2020, the Company recognized a milestone of $450 related to the submission to the FDA of an application to cover use of the products on an Ortho automation platform and during the nine month period ended December 31, 2019, the Company recognized further milestones totaling $1,050 related to the approval by the FDA of thisan application submitted during the year ended March 31, 2019, and a further FDA submission and approval related to the use of the products on another of Ortho’s automation platforms.  There are no further milestone revenues due under this agreement.

In January 2015, the Companythe Company’s subsidiaries, Quotient Suisse and QBD (QS-IP) Limited, entered into a supply and distribution agreement with Ortho related to the commercialization and distribution of certain MosaiQ products.products (the "Prior Ortho Agreement"), which the Company terminated effective as of December 27, 2019. Under the terms of this agreement,the Prior Ortho Agreement, the Company was entitled to receive milestone payments, totaling in aggregate $59.0 million, upon CE-mark and FDA approval, as well as upon the first commercial sale of the relevant MosaiQ products by Ortho within the European Union, United States and within any country outside of these two regions.  In November 2019, Ortho initiated an arbitration proceeding as result of the Company's termination of the Prior Ortho Agreement.  See Note 6, "Commitments and Contingencies—Ortho Arbitration and Settlement," for details.

On September 4, 2020, the Company and Ortho entered into a binding letter agreement (the “Letter Agreement”) pursuant to which the Company and Ortho agreed:

to confirm the termination of the Prior Ortho Agreement and various related contracts;

to end the parties’ disputes regarding the Prior Ortho Agreement by executing mutual releases and terminating their pending arbitration proceeding related to the Prior Ortho Agreement (see Note 6); and

to negotiate in good faith, and use their respective reasonable best efforts to execute, a new distribution agreement (the “New Distribution Agreement”) based on the terms set forth in the Letter Agreement, but if for any reason no such definitive agreement is reached, the Letter Agreement will govern the parties’ respective rights and obligations as a binding contract.

Pursuant to the Letter Agreement, Ortho made an initial, non-refundable milestone payment of $7.5 million to the Company on the date of the Letter Agreement.

In the Letter Agreement, the Company and Ortho have agreed that Ortho has the right to distribute, market and sell a dedicated MosaiQ microarray optimized for the patient transfusion diagnostics market (the “MosaiQ IH3 Microarray”) in the European Territory (defined as the European Economic Area plus the United Kingdom and Switzerland) and in the United States, solely for use in testing the immuno-hematological profile of the blood of medical patients in the course of their care or treatment. Ortho’s rights in the two territories each are for one ten-year term commencing on the receipt of specified regulatory approvals in the respective territory. The Company hadretains the right to distribute, market and sell the immunohematology Microarrays for use in blood donor testing worldwide and in the patient testing market outside of the European Territory and the United States. Ortho’s rights in respect of the MosaiQ IH3 Microarray are exclusive provided it satisfies annual minimum purchase volume requirements in each territory. Ortho also has the non-exclusive right to sell and distribute MosaiQ instruments in the United States and the European Territory for use in testing the immuno-hematological profile of blood of medical patients in the course of their care or treatment. Ortho is required to purchase the MosaiQ IH3 Microarrays, and the instruments, controls and reagents required for their use, only from the Company at specified prices.

In addition to the initial $7.5 million milestone payment, Ortho is required to make up to another $60 million of additional milestone payments upon achievement of certain regulatory milestones and commercial sales benchmarks, including up to $25 million upon the achievement by Ortho of certain cumulative gross revenue hurdles.

The Company has concluded that asthe initial $7.5 million milestone represents a payment in respect of development work undertaken to date in respect of the MosaiQ IH3 Microarray and accordingly has recognized the revenue in the nine month period ended December 31, 2020.

- 11 -


The Company has also concluded that each of thesethe remaining milestones requiredunder the Letter Agreement require significant levels of development work to be undertaken and there wasis no certainty at the start of the projects that the development work wouldwill be successful, these milestones wereare substantive and, accordingly, the revenue would have beenwill be recognized when the milestones wereare achieved. The Company terminated this agreement effective as of December 27, 2019.

In the nine month period ended December 31, 2019,2020, revenue recognized from performance obligations related to prior periods was not material and, atmaterial. At December 31, 2019, revenue2020 revenues expected to be recognized in future periods related to remaining performance obligations was also not material.under the Ortho Letter Agreement were as described above. There were 0 other material revenues to be recognized in future periods related to remaining performance obligations at December 31, 2020.

Research and Development

Research and development expenses consist of costs incurred for company-sponsored and collaborative research and development activities. These costs include direct and research-related overhead expenses. TheOther than materials assessed as having alternative future uses and which are recognized as prepaid expenses, the Company expenses research and development costs, including products manufactured for research and development purposes and the expenses for research under collaborative agreements, as such costs are incurred. Where government grants or tax credits are available for the income concernedsponsorship of such research, the grant receipt is included as a credit against the related expense.

Stock-Based Compensation

Stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as an expense on a straight-line basis over the requisite service period, which is generally the vesting period. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the requisite service periods in the Company’s consolidated statements of comprehensive loss.

In determining fair value of the stock-based compensation payments, the Company uses the Black–Scholes model and a single option award approach for share options, and a barrier option pricing model for multi-year performance based restricted share units (“MRSUs”), both of which requirerequires the input of subjective assumptions. These assumptions include: the fair value of the underlying share, estimating the length of time employees will retain their awards before exercising them (expected term), the estimated volatility of the Company’s publicly listed peersordinary share price over the expected term (expected volatility), risk-free interest rate (interest rate), expected dividends and the number of shares subject to awards that will ultimately not complete their vesting requirements (forfeitures).

Where modifications are made to vesting conditions, the Company considers the nature of the change and accounts for the change in accordance with ASC 715 Compensation – Stock Compensation.  The Company determined that certain modifications made during the nine month periods ended December 31, 2020 and December 31, 2019 were type III in nature and accordingly the original compensation expense related to these awards was reversed and the value of the awards was re-measured at the date of the change and was expensed over the vesting period of the awards concerned.

Share Warrants

As of December 31, 2019,2020, the Company had one class of warrants to purchase ordinary shares outstanding, which comprised warrants that were issued in December 2013 and August 2015 in connection with the establishment or increase of the Company’s then existing secured term loan facility. None of these warrants contain or contained any obligation to transfer value and, as such, the issuance of these warrants has been recorded in additional paid in capital as part of shareholders’ (deficit) equity.

Leases

 

In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update, or ASU 2016-02, Leasesor ASU 2016-02, to enhance the transparency and comparability of financial reporting related to leasing arrangements. The Company adopted ASU 2016-02 on April 1, 2019, or the effective date, and used the effective date as its date of initial application.

 

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. A lease is a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment (an identified asset) for a period of time, in exchange for consideration. The Company determines if the contract conveys the right to control the use of an identified asset for a period of time. The Company assesses throughout the period of use whether the Company has both of the following: (1) the right to obtain substantially all of the economic benefits for use of the identified asset, and (2) the right to direct the use of the identified asset. This determination is reassessed if the terms of the contract are changed. The Company also reviews the terms of the lease in accordance with Accounting Standard Update, or ASU, 2016-02 in order to determine whether the lease concerned is a finance or an operating lease. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less.

 

- 1112 -


 

For finance leases, an asset is included within property and equipment and a lease liability equal to the present value of the minimum lease payments is included in current or long-term liabilities.  Interest expense is recorded over the life of the lease at a constant rate.

Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. The operating lease right-of-use assets also include any lease payments made prior to the commencement date and any initial direct costs incurred, less any lease incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The incremental borrowing rate is determined at lease commencement, or as of April 1, 2019 for operating leases existing upon adoption of ASU 2016-02. The incremental borrowing rate is subsequently reassessed upon modification to the lease arrangement. Operating lease expense is recognized on a straight-line basis over the lease term.

 

In accordance with the guidance in ASU 2016-02, components of a lease should be split into three categories: lease components (e.g., land, building, etc.), non-lease components (e.g., common area maintenance, maintenance, consumables, etc.), and non-components (e.g., property taxes, insurance, etc.). Although separation of lease and non-lease components is required, certain practical expedients are available. In particular, entities may elect a practical expedient to not separate lease and non-lease components and instead account for each lease component and the related non-lease component together as a single component. The Company has elected to account for the lease and non-lease components of each of its operating leases as a single lease component and allocate all of the contract consideration to the lease component only. The lease component results in an operating lease right-of-use asset being recorded on the balance sheet and amortized on a straight-line basis as lease expense.

The finance lease assets and operating lease right-of-use assets are assessed for impairment in accordance with the Company’s accounting policy for long-lived assets.

Derivative Financial Instruments

In the normal course of business, the Company’s financial position is routinely subjected to market risk associated with foreign currency exchange rate fluctuations. The Company’s policy is to mitigate the effect of these exchange rate fluctuations on certain foreign currency denominated business exposures. The Company has a policy that allows the use of derivative financial instruments to hedge foreign currency exchange rate fluctuations on forecasted revenue denominated in foreign currencies. The Company carries derivative financial instruments (derivatives) on the balance sheet at their fair values. The Company does not use derivatives for trading or speculative purposes. The Company does not believe that it is exposed to more than a nominal amount of credit risk in its foreign currency hedges, as counterparties are large, global and well-capitalized financial institutions. To hedge foreign currency risks, the Company uses foreign currency exchange forward contracts, where possible and prudent. These forward contracts are valued using standard valuation formulas with assumptions about future foreign currency exchange rates derived from existing exchange rates, interest rates, and other market factors.

The Company considers its most current forecast in determining the level of foreign currency denominated revenue to hedge as cash flow hedges. The Company combines these forecasts with historical trends to establish the portion of its expected volume to be hedged. The revenue and expenses are hedged and designated as cash flow hedges to protect the Company from exposures to fluctuations in foreign currency exchange rates. If the underlying forecasted transaction does not occur, or it becomes probable that it will not occur, the related hedge gains and losses on the cash flow hedge are reclassified from accumulated other comprehensive loss to the consolidated statement of comprehensive loss at that time.

Income Taxes

The Company accounts for income taxes using an asset and liability approach, which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements, but have not been reflected in taxable income. A valuation allowance is established to reduce deferred tax assets to their estimated realizable value. Therefore, the Company provides a valuation allowance to the extent that is more likely than not that it will generate sufficient taxable income in future periods to realize the benefit of its deferred tax assets. Deferred tax assets and liabilities are classified as noncurrent on the balance sheet.

The Company accounts for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The Company evaluates uncertain tax positions on a quarterly basis and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit and changes in facts or circumstances related to the tax position.

- 1213 -


 

Termination and Transition Charges

Termination charges are recognized as a result of actions to restructure operations. Transition charges are recognized as a result of the retirement of senior employees. Such charges are recognized upon meeting certain criteria, including the finalization of committed plans or agreements and discussions with the impacted employees.  

Loss Contingencies

Loss contingencies from legal proceedings and claims may occur from contractual and other related matters. Accruals are recognized when it is probable that a liability will be incurred and the amount of the loss can be reasonably estimated. Gain contingencies are not recognized until realized. Legal fees are expensed as incurred.

Debt Issuance Costs and Royalty Rights

The Company follows the requirements of Accounting Standards Update 2015-03, Interest — Imputation of Interest (Subtopic 835-30) — Simplifying the Presentation of Debt Issuance Costs, which requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the debt liability rather than as an asset.

On October 14, 2016, June 29, 2018 and May 15, 2019, the Company issued Secured Notes, and, on December 4, 2018, the Company amended the indenture governing the Secured Notes, which amendments became effective on December 18, 2018. In connection with these issuances and this amendment, the Company entered into royalty rights agreements with the subscribers and the consenting note holders, as applicable, which, as of December 31, 2019,2020, provided for an aggregate amount of royalties payable thereunder of 3.4% of net sales of MosaiQ instruments and consumables made in the donor testing market in the United States and the European Union. All of these royalty rights agreements are treated as sales of future revenues that meet the requirements of Accounting Standards Codification Topic 470 “Debt” (“ASC 470”) to be treated as debt. The future cash outflows under the royalty rights agreements have been combined with the issuance costs (which includes the one-time consent payment of $3.9 million paid to holders of our Secured Notes in December 2018) and interest payable to calculate the effective interest rate of the Secured Notes and will beis being expensed through interest expense in the consolidated statement of comprehensive loss using the effective interest rate method over the term of the Secured Notes and royalty rights agreements.

Pension Obligation

The Company maintains a pension plan covering employees in Switzerland pursuant to the requirements of Swiss pension law. Certain aspects of the plan require that it be accounted for as a defined benefit plan pursuant to Accounting Standards Codification Topic, 715 Compensation – Retirement Benefits (“ASC 715”). The Company recognizes an asset for the plan’s overfunded status or a liability for the plan’s underfunded status in its consolidated balance sheets. Additionally, the Company measures the plan’s assets and obligations that determine its funded status as of the end of the year and recognizes the change in the funded status within ‘‘Accumulated other comprehensive loss’’. The service cost component of the net periodic benefit cost is disclosed in the same line item as other employee compensation costs arising from services rendered during the period, and the other components are reported separately from the line item that includes the service cost and within interest expense, net in the consolidated statement of comprehensive loss.

- 14 -


The Company uses an actuarial valuation to determine its pension benefit costs and credits. The amounts calculated depend on a variety of key assumptions, including discount rates and expected return on plan assets. Details of the assumptions used to determine the net funded status are set out in the notes to the Company’s audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2019.2020. The Company’s pension plan assets are assigned to their respective levels in the fair value hierarchy in accordance with the valuation principles described in the ‘‘Fair Value of Financial Instruments’’ section above.

Adoption of New Accounting Standards

 

In FebruaryJune 2016, the FASB issued ASU 2016-02, Leases2016-13, “Financial Instruments – Credit Losses”. The standard, including subsequently issued amendments, requires a financial asset measured on an amortized cost basis, such as accounts receivable, to be presented at the net amount expected to be collected based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that requires lessees to recognize a right-of-use asset and a lease liability on their balance sheet for all leases with lease terms greater than 12 months but recognize expenses in their income statements in a manner similar toaffect the previous guidance. ASU 2016-02 also requires new qualitative and quantitative disclosures to help investors and other financial statement users better understandcollectability of the amount, timing and uncertainty of cash flows arising from leases. The Company’s process of evaluating the impact of ASU 2016-02 has included reviewing all forms of leases and performing a completeness assessment over the lease population. The Company also performed detailed analysis to determine the appropriate incremental borrowing rates used to discount outstanding lease payments.  

reported amount. The Company adopted ASU 2016-022016-13 on April 1, 2019. In adopting this standard the Company applied the package of practical expedients in ASU 2016-02 which allow an entity to not reassess whether any expired or existing contracts are or contain leases, lease classification of any expired or existing leases and the accounting for any initial direct costs on any expired or existing leases. The Company also elected the additional transitional approach prescribed under ASU 2018-11 to allow the Company to apply the new standard from the date of adoption, rather than adjusting comparative periods, and recognize a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.

The results for the nine month period to December 31, 2019 reflect the adoption of ASU 2016-02 guidance while the results for the nine month period to December 31, 2018 and the year to March 31, 2019 were prepared under the guidance of the previous leasing standard (Accounting Standard Codification 840).2020. The adoption of ASU 2016-02 hasthis standard did not hadhave a material impact on the Company’s consolidated statements of comprehensive loss or consolidated statements of cash flows.

- 13 -


The adoption of ASU 2016-02 resulted in the following impact on its consolidated balance sheet:

(i)

no change in the carrying values of assets or liabilities related to the Company’s finance leases,

(ii)

the recording of right-of-use assets and corresponding lease liabilities related to the Company’s operating leases, adjusted for existing balances of accrued rent liabilities and deferred lease rental benefit, and

(iii)

adjustments to reclassify the deferred gain on a sale and leaseback transaction to accumulated deficit as of the transition date.

The cumulative effect of adopting ASU 2016-02 to all leases that had commenced at or prior to April 1, 2019 was as follows:

Balance sheet captions impacted by ASU 2016-02

 

31 March 2019 (prior to adoption of ASU 2016-02)

 

 

Effect of the adoption of ASU 2016-02

 

 

March 31, 2019 (As adjusted)

 

Operating lease right-of use assets (1)

 

$

 

 

$

18,478

 

 

$

18,478

 

Current portion of operating lease liability (2)

 

 

 

 

 

3,130

 

 

 

3,130

 

Operating lease liability less current portion (3)

 

 

 

 

 

16,564

 

 

 

16,564

 

Current portion of deferred lease rental benefit (4)

 

 

435

 

 

 

(435

)

 

 

 

Deferred lease rental benefit, less current portion (5)

 

 

1,144

 

 

 

(1,144

)

 

 

 

Accumulated deficit (6)

 

 

(381,025

)

 

 

363

 

 

 

(380,662

)

(1)

Recognition of operating lease right-of-use assets and adjusted for the accrued rent and deferred lease rental benefit reclassifications referred to in footnotes (4) and (5) below.

(2)

Recognition of current portion of operating lease liabilities.

(3)

Recognition of the long-term portion of operating lease liabilities.

(4)

Current portion of deferred gain on sale and lease back transaction transferred to accumulated deficit and reclassification of current portion of deferred lease rental benefit to operating lease right-of-use assets.

(5)

Long-term portion of deferred gain on sale and lease back transaction transferred to accumulated deficit and reclassification of accrued rent to operating lease right-of-use assets.

(6)

Transfer of deferred gain on sale and leaseback transaction to accumulated deficit.

The Company has included additional disclosures in Note 12 to itsunaudited condensed consolidated financial statements regarding its leasing portfolio.

In the condensed consolidated statement of cash flows the non-cash amortization of deferred lease rental benefit and movements in other non-cash operating lease accruals in the nine month period ended December 31, 2018 has been retitled as increase in deferred lease rentals.

Recent Accounting Pronouncements Not Yet Adoptedrelated disclosures.

 

In August 2018, the FASB issued ASU 2018-14, “Compensation Retirement Benefits - Defined Benefit Plans -General (Subtopic 715-20)” or ASU 2018-14. ASU 2018-14 removes the requirements to disclose the amounts in accumulated other comprehensive income (loss) expected to be recognized as components of net periodic benefit cost over the next fiscal year and other disclosure requirements. In addition, the ASU adds the requirement to disclose an explanation for any significant gains and losses related to changes in the benefit obligation for the period. The ASU is effective for fiscal years ending after December 15, 2020 and will be applied on a retrospective basis to all periods presented. Early adoption is permitted. The Company continues to evaluate the impact thatadopted ASU 2018-14 on April 1, 2020. The adoption of this guidance willstandard did not have a material impact on itsthe unaudited condensed consolidated financial statements and related disclosures, but does not expect it to have a material impact.disclosures.

In June 2016, the FASB issued ASU 2016-13, “Financial Instruments – Credit Losses”. The standard requires a financial asset measured on an amortized cost basis, such as accounts receivable, to be presented at the net amount expected to be collected based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The ASU is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years, and requires the modified retrospective approach. Early adoption is permitted.  The Company continues to evaluate the impact that adoption of this guidance will have on its consolidated financial statements and related disclosures, but does not expect it to have a material impact.

- 14 -


 

Note 3. Intangible Assets

 

December 31, 2019

 

 

December 31, 2020

 

 

Gross

Carrying

Amount

 

 

Accumulated

Amortization

 

 

Net Carrying

Amount

 

 

Weighted

Average

Remaining

Useful Life

 

 

Gross

Carrying

Amount

 

 

Accumulated

Amortization

 

 

Net Carrying

Amount

 

 

Weighted

Average

Remaining

Useful Life

 

Customer relationships

 

$

2,596

 

 

$

(2,596

)

 

$

 

 

 

 

 

$

2,687

 

 

$

(2,687

)

 

$

 

 

 

 

Brands associated with acquired cell lines

 

 

535

 

 

 

(165

)

 

 

370

 

 

27.7 years

 

 

 

554

 

 

 

(185

)

 

 

369

 

 

26.9 years

 

Product licenses

 

 

904

 

 

 

(587

)

 

 

317

 

 

3.7 years

 

 

 

936

 

 

 

(673

)

 

 

263

 

 

3.0 years

 

Other intangibles

 

 

169

 

 

 

(169

)

 

 

 

 

 

 

 

 

175

 

 

 

(175

)

 

 

 

 

 

 

Total

 

$

4,204

 

 

$

(3,517

)

 

$

687

 

 

16.3years

 

 

$

4,352

 

 

$

(3,720

)

 

$

632

 

 

16.7 years

 

 

 

March 31, 2019

 

 

March 31, 2020

 

 

Gross

Carrying

Amount

 

 

Accumulated

Amortization

 

 

Net Carrying

Amount

 

 

Weighted

Average

Remaining

Useful Life

 

 

Gross

Carrying

Amount

 

 

Accumulated

Amortization

 

 

Net Carrying

Amount

 

 

Weighted

Average

Remaining

Useful Life

 

Customer relationships

 

$

2,564

 

 

$

(2,564

)

 

$

 

 

 

 

 

$

2,436

 

 

$

(2,436

)

 

$

 

 

 

 

Brands associated with acquired cell lines

 

 

529

 

 

 

(153

)

 

 

376

 

 

28.4 years

 

 

 

502

 

 

 

(158

)

 

 

344

 

 

27.4 years

 

Product licenses

 

 

890

 

 

 

(515

)

 

 

375

 

 

4.2 years

 

 

 

849

 

 

 

(568

)

 

 

281

 

 

3.3 years

 

Other intangibles

 

 

167

 

 

 

(167

)

 

 

 

 

 

 

 

 

158

 

 

 

(158

)

 

 

 

 

 

 

Total

 

$

4,150

 

 

$

(3,399

)

 

$

751

 

 

16.3 years

 

 

$

3,945

 

 

$

(3,320

)

 

$

625

 

 

16.5 years

 

 

- 15 -


 

Note 4. Debt

Long-term debt comprises:

 

December 31,

2019

 

 

March 31,

2019

 

 

December 31,

2020

 

 

March 31,

2020

 

Total debt

 

$

145,000

 

 

$

120,000

 

 

$

145,000

 

 

$

145,000

 

Less current portion

 

 

 

 

 

 

 

 

24,167

 

 

 

 

Long-term debt

 

$

145,000

 

 

$

120,000

 

Deferred debt costs and royalty liability, net of amortization

 

 

8,717

 

 

 

1,855

 

 

$

153,717

 

 

$

121,855

 

 

$

120,833

 

 

$

145,000

 

Royalty liability

 

$

20,886

 

 

$

15,473

 

Deferred debt costs, net of amortization

 

 

(6,229

)

 

 

(7,449

)

Long-term debt, less current portion

 

$

135,490

 

 

$

153,024

 

The Company’s debt at December 31, 2019 was comprised of2020 and March 31, 2020, comprises the Secured Notes. On October 14, 2016, the Company completed the private placement of up to $120 million aggregate principal amount of the Secured Notes and entered into an indenture governing the Secured Notes with the guarantors party thereto and U.S. Bank National Association, a national banking association, as trustee and collateral agent. The Company issued $84 million aggregate principal amount of the Secured Notes on October 14, 2016 and an additional $36 million aggregate principal amount of the Secured Notes on June 29, 2018. On December 18, 2018, the Company also completed certain amendments to the indenture governing the Secured Notes. The amendments included an increase to the aggregate principal amount of Secured Notes that can be issued under the indenture from $120 million to up to $145 million following the European CE Marking of the Company’s initial MosaiQ IH Microarray. On April 30, 2019, the Company was notified that it had received the European CE Marking of the initial MosaiQ IH Microarray and, on May 15, 2019, the Company issued the additional $25 million of Secured Notes.

The obligations of the Company under the indenture and the Secured Notes are unconditionally guaranteed on a secured basis by the guarantors, which include all the Company’s subsidiaries, and the indenture governing the Secured Notes contains customary events of default. The Company and its subsidiaries must also comply with certain customary affirmative and negative covenants, including a requirement to maintain six-months of interest in a cash reserve account maintained with the collateral agent. Upon the occurrence of a Change of Control, subject to certain conditions, or certain Asset Sales (each, as defined in the indenture), holders of the Secured Notes may require the Company to repurchase for cash all or part of their Secured Notes at a repurchase price equal to 101% or 100%, respectively, of the principal amount of the Secured Notes to be repurchased, plus accrued and unpaid interest to the date of repurchase.

The Company paid $8.7 million of the total proceeds of the three issuances into the cash reserve account maintained with the collateral agent under the terms of the indenture, $1.5 million of which related to the third issuance on May 15, 2019.

- 15 -


Interest on the Secured Notes accrues at a rate of 12% per annum and is payable semi-annually on April 15 and October 15 of each year commencing on April 15, 2017. Commencing on April 15, 2021, the Company will also be required to pay an installment of principal of the Secured Notes on each April 15 and October 15 until April 15, 2024 pursuant to a fixed amortization schedule.

- 16 -


In connection with the three issuances of the Secured Notes as well as the December 2018 amendment of the related indenture, the Company has entered into royalty rights agreements, pursuant to which the Company has agreed to pay 3.4% of the aggregate net sales of MosaiQ instruments and consumables made in the donor testing market in the United States and the European Union. The royalties will be payable beginning on the date that the Company or its affiliates makes its first sale of MosaiQ consumables in the donor testing market in the European Union or the United States and will end on the last day of the calendar quarter in which the eighth anniversary of the first sale date occurs. The royalty rights agreements are treated as sales of future revenues that meet the requirements of Accounting Standards Codification Topic 470 “Debt” to be treated as debt. The estimated future cash outflows under the royalty rights agreements, estimated at $106.4 million at December 31, 2020 and$87.0 at March 31, 2020, have been combined with the Secured Notes issuance costs and interest payable to calculate the effective interest rate of the Secured Notes and will be expensed through interest expenses using the effective interest rate method over the term of the Secured Notes and such royalty rights agreements. Estimating the future cash outflows under the royalty rights agreements requires the Company to make certain estimates and assumptions about future sales of MosaiQ products. These estimates of the magnitude and timing of MosaiQ sales are subject to significant variability due to the current status of development of MosaiQ products, and thus are subject to significant uncertainty. Therefore, the estimates are likely to change as the Company gains experience of marketing MosaiQ, which may result in future adjustments to the accretion of the interest expense and amortized cost based carrying value of the Secured Notes.

At December 31, 2019,2020, the outstanding debt was repayable as follows:

Within 1 year

 

$

 

 

$

24,167

 

Between 1 and 2 years

 

 

24,167

 

 

 

42,291

 

Between 2 and 3 years

 

 

42,292

 

 

 

48,334

 

Between 3 and 4 years

 

 

48,333

 

 

 

30,208

 

Between 4 and 5 years

 

 

30,208

 

 

 

 

Total debt

 

$

145,000

 

 

$

145,000

 

 

 

 

Note 5. Consolidated Balance Sheet Detail

Inventory

The following table summarizes inventory by category for the dates presented:

 

December 31,

2019

 

 

March 31,

2019

 

 

December 31,

2020

 

 

March 31,

2020

 

Raw materials

 

$

9,227

 

 

$

8,216

 

 

$

10,284

 

 

$

9,737

 

Work in progress

 

 

7,595

 

 

 

4,959

 

 

 

10,060

 

 

 

8,522

 

Finished goods

 

 

2,969

 

 

 

2,376

 

 

 

3,365

 

 

 

2,242

 

Total inventories

 

$

19,791

 

 

$

15,551

 

 

$

23,709

 

 

$

20,501

 

 

Inventory at December 31, 20192020 included $7,520$8,038 of raw materials, $3,980$5,103 of work in progress and $641$1,266 of finished goods related to the MosaiQ project. Inventory at March 31, 20192020, included $6,187$8,093 of raw materials and $2,311$4,395 of work in progress and $235$368 of finished goods related to the MosaiQ project. During the quarter ended December 31, 2020 the Company recorded inventory provisions of $2,015 in respect of certain raw materials and work-in-progress items related to the MosaiQ project following evaluation of further development data and corresponding changes in manufacturing processes.  

Property and equipment

The following table summarizes property and equipment by categories for the dates presented:

 

December 31,

2019

 

 

March 31,

2019

 

 

December 31,

2020

 

 

March 31,

2020

 

Plant and equipment

 

$

56,440

 

 

$

51,327

 

 

$

65,878

 

 

$

57,726

 

Leasehold improvements

 

 

32,411

 

 

 

32,047

 

 

 

34,535

 

 

 

31,395

 

Total property and equipment

 

 

88,851

 

 

 

83,374

 

 

 

100,413

 

 

 

89,121

 

Less: accumulated depreciation

 

 

(45,426

)

 

 

(36,081

)

 

 

(59,519

)

 

 

(48,956

)

Total property and equipment, net

 

$

43,425

 

 

$

47,293

 

 

$

40,894

 

 

$

40,165

 

- 17 -


 

 

- 16 -


Depreciation expenses were $2,901$2,343 and $3,058$2,901 in the quarters ended December 31, 20192020 and December 31, 2018,2019, respectively, and $8,923$6,433 and $9,428$8,923 in the nine month periods ended December 31, 2020 and 2019, and 2018, respectively. During the quarter ended June 30, 2020, the Company reassessed the useful economic lives of equipment used in the production line at its facility in Eysins, Switzerland. Based on lower utilization rates than initially estimated, the remaining useful lives of the equipment was increased from 4 years to 6 years. The impact of these changes in remaining useful lives was to reduce the depreciation expenses for the nine month period ended December 31, 2020 by $467.  

Accrued compensation and benefits

Accrued compensation and benefits consist of the following:

 

December 31,

2019

 

 

March 31,

2019

 

 

December 31,

2020

 

 

March 31,

2020

 

Salary and related benefits

 

$

200

 

 

$

638

 

 

$

262

 

 

$

635

 

Accrued vacation

 

 

554

 

 

 

495

 

 

 

1,013

 

 

 

521

 

Accrued payroll taxes

 

 

1,639

 

 

 

1,316

 

 

 

756

 

 

 

1,200

 

Accrued incentive payments

 

 

2,250

 

 

 

3,700

 

 

 

2,813

 

 

 

3,700

 

Accrued termination and transition payments

 

 

1,256

 

 

 

 

 

 

 

 

 

1,154

 

Total accrued compensation and benefits

 

$

5,899

 

 

$

6,149

 

 

$

4,844

 

 

$

7,210

 

 

In the quarteryear ended DecemberMarch 31, 2019,2020, the Company incurred termination benefit costs of $856$1,323 in respect of a restructuring of its operations. The Company expects to complete the restructuring was completed during the quarteryear ended March 31, 2020.  In the quarteryear ended DecemberMarch 31, 20192020 the Company also incurred transition benefit costs of $400$807 in respect of the transitional arrangements with its former chief financial officer and its former group financial controller. No termination benefit or transition benefit costsThe final payments under these arrangements were incurred inmade during the quarter or nine month period ended December 31, 2018.June 30, 2020.

 

Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consist of the following:

 

December 31,

2019

 

 

March 31,

2019

 

 

December 31,

2020

 

 

March 31,

2020

 

Accrued legal and professional fees

 

$

1,739

 

 

$

405

 

 

$

728

 

 

$

829

 

Accrued interest

 

 

3,718

 

 

 

6,628

 

 

 

3,718

 

 

 

8,056

 

Goods received not invoiced

 

 

2,456

 

 

 

1,337

 

 

 

1,772

 

 

 

1,724

 

Accrued capital expenditure

 

 

1,256

 

 

 

801

 

 

 

2,188

 

 

 

1,287

 

Other accrued expenses

 

 

3,670

 

 

 

3,287

 

 

 

2,945

 

 

 

3,594

 

Total accrued expenses and other current liabilities

 

$

12,839

 

 

$

12,458

 

 

$

11,351

 

 

$

15,490

 

 

Note 6. Commitments and Contingencies

Hedging arrangements

The Company’s subsidiary in the United Kingdom (“UK”) has entered into three3 contracts to sell $500 and purchase pounds sterling at £1:$1.3245 in each calendar month from January 20202021 through March 2020, three2021 at £1:$1.335, 3 contracts to sell $500 and purchase pounds sterling at £1:$1.30 in each calendar month from April 20202021 through June 2020, three2021 at £1:$1.2630, 3 contracts to sell $500 and purchase pounds sterling at £1:$1.28 in each calendar month from July 20202021 through September 20202021 at £1:$1.260, and three3 contracts to sell $500 and purchase pounds sterling at £:$1.2520 in each calendar month from October 20202021 through December 20202021 at £1:$1.3090, as hedges of its U.S. dollar denominated revenues. The fair values of these contracts in place at December 31, 2020, and similar contracts in place at March 31, 2020, amounted to assets of $344 and liabilities of $227, respectively.

- 18 -


Fair value measurements

The following table summarizes the Company’s assets and liabilities that are measured at fair value on a recurring basis, by level, within the fair value hierarchy:

 

 

 

December 31, 2019

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pension plan assets(1)

 

$

 

 

$

11,355

 

 

$

 

 

$

11,355

 

Short-term investments(2)

 

 

133,371

 

 

 

 

 

 

 

 

 

133,371

 

Foreign currency forward contracts(3)

 

$

 

 

$

146

 

 

$

 

 

$

146

 

Total assets measured at fair value

 

$

133,371

 

 

$

11,501

 

 

$

 

 

$

144,872

 

- 17 -


 

 

December 31, 2019

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency forward contracts(3)

 

$

 

 

$

7

 

 

$

 

 

$

7

 

Total liabilities measured at fair value

 

$

 

 

$

7

 

 

$

 

 

$

7

 

 

 

December 31, 2020

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pension plan assets(1)

 

$

 

 

$

16,131

 

 

$

 

 

$

16,131

 

Short-term investments(2)

 

 

131,062

 

 

 

 

 

 

 

 

 

131,062

 

Foreign currency forward contracts(3)

 

$

 

 

$

344

 

 

$

 

 

$

344

 

Total assets measured at fair value

 

$

131,062

 

 

$

16,475

 

 

$

 

 

$

147,537

 

 

 

March 31, 2019

 

 

March 31, 2020

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pension plan assets(1)

 

$

 

 

$

10,416

 

 

$

 

 

$

10,416

 

 

$

 

 

$

12,436

 

 

$

 

 

$

12,436

 

Short-term investments(2)

 

 

90,729

 

 

 

 

 

 

 

 

 

90,729

 

 

 

116,871

 

 

 

 

 

 

 

 

 

116,871

 

Total assets measured at fair value

 

$

90,729

 

 

$

10,416

 

 

$

 

 

$

101,145

 

 

$

116,871

 

 

$

12,436

 

 

$

 

 

$

129,307

 

 

 

March 31, 2019

 

 

March 31, 2020

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency forward contracts(3)

 

$

 

 

$

70

 

 

$

 

 

$

70

 

 

$

 

 

$

227

 

 

$

 

 

$

227

 

Total liabilities measured at fair value

 

$

 

 

$

70

 

 

$

 

 

$

70

 

 

$

 

 

$

227

 

 

$

 

 

$

227

 

 

(1)

The fair value of pension plan assets has been determined as the surrender value of the portfolio of active insured employees held within the Swiss LifeAXA LLP Foundation Suisse Romande collective investment fund. See Note 10, “Defined Benefit Pension Plans”.

(2)

The fair value of short-term investments has been determined based on the quoted value of the units held in the money market fund at the balance sheet date.  See Note 2, “Summary of Significant Accounting Policies – Short-term Investments”.

(3)

The fair value of foreign currency forward contracts has been determined by calculating the present value of future cash flows, estimated using market-based observable inputs including forward and spot exchange rates and interest rate curves obtained from third party market price quotations.

The total unrealized gains on the short-term investments were $638 and $1,154 in the nine month periods ended December 31, 2020 and December 31, 2019, respectively.  The amount of these unrealized gains reclassified to earnings were $1,010 and $812 in the nine month periods ended December 31, 2020 and December 31, 2019, respectively.

Ortho Arbitration and Settlement

 

The Company'sCompany’s subsidiaries, Quotient Suisse SA and QBD (QS-IP) Limited are involved in an arbitrationwere party to the Prior Ortho Agreement with Ortho related to the termination of the Company's former supply and distribution agreement with Ortho for the commercialization and distribution of certain MosaiQ products.  See Note 2, “Summary of Significant Accounting Policies—Revenue Recognition,” for information regarding this agreement.the Prior Ortho is seekingAgreement.  The Company and an affiliate of Ortho also entered into a subscription agreement pursuant to which the affiliate subscribed for newly issued ordinary shares of the Company and newly issued 7% cumulative redeemable preference shares, of no par value, of the Company for an aggregate subscription price of approximately $25 million.

On November 27, 2019, the Company delivered a notice to Ortho that it had terminated the Prior Ortho Agreement, effective as of December 27, 2019.  The Company did not realize any revenue under the Prior Ortho Agreement prior to its termination.  

- 19 -


On or about November 17, 2019, Ortho initiated an arbitration proceeding in which it sought a declaration that the Company's subsidiaries doCompany did not have the right to terminate the agreement,Prior Ortho Agreement, specific performance of certain provisions of the agreement,Prior Ortho Agreement, and damages.damages including in respect of the difference in amounts Ortho invested in the Company’s shares and their market value.  The Company is pursuingpursued counterclaims against Ortho, including that it had the right to terminate the Prior Ortho Agreement and damages that included the milestone payments due under the Prior Ortho Agreement (see Note 2, "Summary of Significant Accounting Policies—Revenue Recognition," for damages.  Althoughdetails).  In addition, on December 20, 2019, the Company believesentered into an agreement with Ortho pursuant to which it agreed, while the arbitration was pending, not to grant commercialization rights in respect of products that Ortho's allegations areoverlapped with Ortho’s rights under the Prior Ortho Agreement without merit,prior written notice to Ortho.

On September 4, 2020, the Company cannot currently estimate a reasonably possible loss or rangeand Ortho entered into the Letter Agreement,  pursuant to which the Company and Ortho agreed to confirm the termination of loss for thisthe Prior Ortho Agreement and various related contracts and to end the parties’ disputes regarding the Prior Ortho Agreement by executing mutual releases and terminating their pending arbitration dueproceeding related to the complexitiesPrior Ortho Agreement.

The Company and uncertainty surroundingOrtho also agreed to negotiate in good faith, and use their respective reasonable best efforts to execute, the arbitration (including thatNew Distribution Agreement based on the arbitrationterms set forth in the Letter Agreement, but if for any reason no such definitive agreement is reached, the Letter Agreement will govern the parties’ respective rights and obligations as a binding contract. See Note 2, "Summary of Significant Accounting Policies—Revenue Recognition," for further details regarding the commercial terms included in its early stages) and the nature of the claims.Letter Agreement.

 

 

Note 7. Ordinary and Preference Shares

Ordinary shares

The Company’s issued and outstanding ordinary shares were as follows:

 

Shares Issued

and Outstanding

 

 

 

 

 

 

Shares Issued

and Outstanding

 

 

 

 

 

 

December 31,

2019

 

 

March 31,

2019

 

 

Par value

 

 

December 31,

2020

 

 

March 31,

2020

 

 

Par value

 

Ordinary shares

 

 

80,256,946

 

 

 

65,900,447

 

 

$

 

 

 

101,075,845

 

 

 

80,398,326

 

 

$

 

Total

 

 

80,256,946

 

 

 

65,900,447

 

 

$

 

 

 

101,075,845

 

 

 

80,398,326

 

 

$

 

- 18 -


On September 15, 2020, the Company completed a public offering of 20,294,117 newly issued ordinary shares at $4.25 per share which raised $86.3 million of gross proceeds before underwriting discounts and other offering expenses of $5.6 million.

Preference shares

The Company’s issued and outstanding preference shares consist of the following:

 

 

Shares Issued

and Outstanding

 

 

Liquidation

amount per share

 

 

Shares Issued

and Outstanding

 

 

Liquidation

amount per share

 

 

December 31,

2019

 

 

March 31,

2019

 

 

December 31,

2019

 

 

March 31,

2019

 

 

December 31,

2020

 

 

March 31,

2020

 

 

December 31,

2020

 

 

March 31,

2020

 

7% Cumulative Redeemable

Preference shares

 

 

666,665

 

 

 

666,665

 

 

$

30.24

 

 

$

29.06

 

 

 

666,665

 

 

 

666,665

 

 

$

31.82

 

 

$

30.64

 

Total

 

 

666,665

 

 

 

666,665

 

 

 

 

 

 

 

 

 

 

 

666,665

 

 

 

666,665

 

 

 

 

 

 

 

 

 

 

On November 12, 2019The 7% Cumulative Redeemable Preference shares were issued to Ortho-Clinical Diagnostics Finco S.A.R.L., an affiliate of Ortho on January 29, 2015 at a subscription price of $22.50 per share. These preference shares are redeemable at the request of the shareholder on the “Redemption Trigger Date” which is currently the date of the eighth anniversary of the date of issue of the preference shares, but the Company completed a public offering of 13,800,000 newly issued ordinary shares at $7.00 per share which raised $96.6 million of gross proceeds before underwriting discounts and other offering expenses of $6.2 million.

Effective as of November 13, 2019may further extend the Company terminated its Open Market Sales Agreement with Jeffries LLC for the Company’s at-the-market public offering, or the Sales Agreement. The Company has not sold any ordinary shares pursuantredemption date in one year increments up to the Sales Agreement and the Company was not subject to any termination penalties related to the terminationtenth anniversary of the Sales Agreement.date of issue. Because the 7% Cumulative Redeemable Preference shares are redeemable at the option of the shareholders, they are shown as a liability in the unaudited condensed consolidated balance sheet.

- 20 -


 

Note 8. Share-Based Compensation

The Company records share-based compensation expense in respect of options multi-year performance based restricted share units (“MRSUs”) and restricted share units (“RSUs”) issued under its share incentive plans. Share-based compensation expense amounted to $1,196$1,214 and $1,073$1,196 in the quarters ended December 31, 20192020 and December 31, 2018,2019, respectively, and $3,375$3,498 and $3,576$3,375 in the nine month periods ended December 31, 20192020 and December 31, 2018,2019, respectively.

Share option activity

The following table summarizes share option activity:

 

Number

of Share

Options

Outstanding

 

 

Weighted

Average

Exercise Price

 

 

Weighted

Average

Remaining Contractual Life

(Months)

 

 

Number

of Share

Options

Outstanding

 

 

Weighted

Average

Exercise Price

 

 

Weighted

Average

Remaining Contractual Life

(Months)

 

Outstanding — March 31, 2019

 

 

1,936,397

 

 

$

7.77

 

 

 

78

 

Outstanding — March 31, 2020

 

 

1,848,052

 

 

$

7.73

 

 

 

70

 

Granted

 

 

85,623

 

 

 

8.69

 

 

 

120

 

 

 

258,026

 

 

 

5.38

 

 

 

120

 

Exercised

 

 

(85,920

)

 

 

4.70

 

 

 

 

 

 

(46,464

)

 

 

3.58

 

 

 

 

Forfeited

 

 

(76,121

)

 

 

12.84

 

 

 

 

 

 

(94,354

)

 

 

10.38

 

 

 

 

Outstanding —December 31, 2019

 

 

1,859,979

 

 

$

7.75

 

 

 

70

 

Exercisable — December 31, 2019

 

 

1,513,110

 

 

$

7.91

 

 

 

63

 

Outstanding — December 31, 2020

 

 

1,965,260

 

 

$

7.40

 

 

 

69

 

Exercisable — December 31, 2020

 

 

1,635,538

 

 

$

7.74

 

 

 

60

 

 

 

 

 

 

 

 

 

 

 

 

 

The closing price of the Company’s ordinary shares on Thethe Nasdaq Global Market at December 31, 20192020 was $9.51.$5.21.

The following table summarizes the options granted in the current financial year ending March 31, 2021 with their exercise prices, the fair value of ordinary shares as of the applicable grant date, and the intrinsic value:

value, if any:

Grant Date

 

Number of

Options Granted

 

 

Exercise Price

 

 

Ordinary

Shares

Fair Value Per

Share at Grant

Date

 

 

Per Share

Intrinsic

Value of

Options

 

July 16, 2019

 

 

28,517

 

 

$

10.52

 

 

$

10.52

 

 

$

6.48

 

October 31, 2019

 

 

57,106

 

 

$

7.78

 

 

$

7.78

 

 

$

4.90

 

Grant Date

 

Number of

Options Granted

 

 

Exercise Price

 

 

Ordinary

Shares

Fair Value Per

Share at Grant

Date

 

 

Per Share

Intrinsic

Value of

Options

 

May 24, 2020

 

 

60,438

 

 

$

7.69

 

 

$

7.69

 

 

$

4.96

 

September 1, 2020

 

 

45,922

 

 

4.81

 

 

4.81

 

 

3.07

 

October 29, 2020

 

 

81,666

 

 

 

4.55

 

 

 

4.55

 

 

 

2.93

 

October 30, 2020

 

 

70,000

 

 

4.72

 

 

4.72

 

 

3.05

 

- 19 -


Determining the fair value of share incentive awardsoptions

The fair value of each grant of share incentive grantoptions was determined by the Company using the Black-Scholes optionsBlack Scholes option pricing model. The total fair value of option awards in the nine month periods ended December 31, 2020 and December 31, 2019 amounted to $889 and $470, respectively.

Assumptions used in the option pricing models are discussed below. Each of these inputs is subjective and generally requires significant judgment to determine.

Expected volatility. The expected volatility was based on the historical share volatilities of a numberprice volatility of the Company’s publicly listed peersshares over a period equal to the expected terms of the options, as the Company did not have a sufficient trading history to use the volatility of its own ordinary shares.options.

Fair value of ordinary shares. The Since the Company’s initial public offering in April 2014, the fair value of the ordinary shares washas been based uponon the closingshare price of the Company’s shares on Thethe Nasdaq Global Market on the last trading dayimmediately prior to the dategrant of grant.the options concerned.

Risk-Free Interest Rate. The risk-free interest rate wasis based on the US TreasuryUK Government 10-year bond yield curve in effect at the time of grant.grant prior to the initial public offering and 10-year U.S. Treasury Stock for awards from April 2014 onwards.

Expected term.The expected term wasis determined after giving consideration to the contractual terms of the share-based awards, graded vesting schedules ranging from one to three years and expectations of future employee behavior as influenced by changes to the terms of the Company’sits share-based awards.

- 21 -


Expected dividend. According to the terms of the awards, the exercise price of the options is adjusted to take into account any dividends paid. As a result, dividends wereare not required as an input to the model, as these reductions in the share price are offset by a corresponding reduction in exercise price.

A summary of the assumptions applicable to the share options issued in the current financial yearnine month period ended December 31, 2020 is as follows:

 

May 24, 2020

 

 

September 1, 2020

 

 

October 29, 2020

 

 

October 30, 2020

 

Risk-free interest rate

 

0.65

%

 

 

0.69

%

 

 

0.81

%

 

 

0.87

%

Expected lives (years)

 

6

 

 

 

6

 

 

 

6

 

 

 

6

 

Volatility

 

74.50

%

 

 

73.30

%

 

 

74.30

%

 

 

74.30

%

Dividend yield

 

 

 

 

 

 

 

 

 

 

 

Grant date fair value (per share)

$

7.69

 

 

$

4.81

 

 

$

4.55

 

 

$

4.72

 

Number granted

 

60,438

 

 

 

45,922

 

 

 

81,666

 

 

 

70,000

 

 

 

 

July 16, 2019

 

 

October 31, 2019

 

Risk-free interest rate

 

 

2.10

%

 

 

1.77

%

Expected lives (years)

 

 

6

 

 

 

6

 

Volatility

 

 

67.39

%

 

 

70.14

%

Dividend yield

 

 

 

 

 

 

Grant date fair value (per share)

 

$

10.52

 

 

$

7.78

 

Number granted

 

 

28,517

 

 

 

57,106

 

 

 

A summary of the RSUs in issue at December 31, 20192020 is as follows:

 

Number

of RSUs

Outstanding

 

 

Weighted

Average

Remaining

Vesting Period

(Months)

 

Period in which the

target must be

achieved

 

Number

of RSUs

Outstanding

 

 

Weighted

Average

Remaining

Vesting Period

(Months)

 

Period in which the

target must be

achieved

RSUs subject to time based vesting

 

 

726,839

 

 

11

 

N/A

 

 

875,387

 

 

12

 

N/A

RSUs subject to milestone based vesting

 

 

55,000

 

 

N/A

 

N/A

 

 

118,650

 

 

N/A

 

N/A

 

At December 31, 2019, 726,8392020, 875,387  RSUs were subject to time-based vesting and the weighted average remaining vesting period was 1112 months.  In addition, 55,000118,650 RSUs were subject to vesting based on the achievement of various business milestones related mainly to the development, approval and marketing of MosaiQ.

 

 

Note 9. Income Taxes

A reconciliation of the income tax expense at the statutory rate to the provision for income taxes is as follows:

 

Quarter ended

 

 

Nine months ended

 

 

December 31,

 

 

December 31,

 

 

Quarter ended December 31,

 

 

Nine months ended December 31,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Income tax expense at statutory rate

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

Impact of tax uncertainties

 

$

1,455

 

 

 

 

 

 

$

1,455

 

 

 

 

 

Foreign tax rate differential

 

 

(1,436

)

 

 

(1,328

)

 

 

(3,035

)

 

 

(3,812

)

 

 

13

 

 

 

(1,436

)

 

 

(1,233

)

 

 

(3,035

)

Increase in valuation allowance against deferred

tax assets

 

 

1,450

 

 

 

1,339

 

 

 

3,076

 

 

 

3,845

 

 

 

3

 

 

 

1,450

 

 

 

1,281

 

 

 

3,076

 

Provision for income tax

 

$

14

 

 

$

11

 

 

$

41

 

 

$

33

 

 

$

1,471

 

 

$

14

 

 

$

1,503

 

 

$

41

 

- 2022 -


 

 

Significant components of deferred tax are as follows:

 

 

December 31,

2019

 

 

March 31,

2019

 

Provisions and reserves

 

$

1,484

 

 

$

1,442

 

Fixed asset basis difference

 

 

44

 

 

 

34

 

Operating lease liability

 

 

3,994

 

 

 

 

Net operating loss carry forwards

 

 

20,313

 

 

 

17,330

 

Gross deferred tax assets

 

$

25,835

 

 

$

18,806

 

Operating lease right-of-use assets

 

$

(3,994

)

 

$

 

Net deferred tax asset

 

$

21,841

 

 

$

18,806

 

Valuation allowance

 

 

(21,277

)

 

 

(18,201

)

Total

 

$

564

 

 

$

605

 

The balance sheet classification of deferred tax is as follows:

 

 

December 31,

2019

 

 

March 31,

2019

 

Net noncurrent deferred tax assets

 

$

564

 

 

$

605

 

Total

 

$

564

 

 

$

605

 

 

In connection with the sale and leaseback transaction of the BiocampusCompany’s conventional reagents manufacturing facility, near Edinburgh, Scotland (the “Alan Robb Campus (“ARC”) facility”) that was completed in March 2018, the Company has agreed to transfer tax allowances related to certain other property, plant and equipment to the purchaser of the facility. An election to effect the transfer of these allowances to the purchaser has been made, but due to uncertainty regarding whether the election will be effective, the tax effect of the transfer of the allowances hashad not previously been recorded in the financial statements as atstatements. The Company has determined that during the quarter ended December 31, 2019. If the transfer of the allowances was regarded as being2020 it is now more likely than not that this election will be effective at December 31, 2019, the financial statements would reflect an additionaland accordingly a net deferred tax expense of $1,004$1,455 and an equivalent deferred tax liability.liability have been recorded, including associated adjustments to valuation allowances.  

Significant components of deferred tax are as follows:

 

 

December 31,

2020

 

 

March 31,

2020

 

Provisions and reserves

 

$

1,521

 

 

$

1,315

 

Operating lease liability

 

 

4,089

 

 

 

3,409

 

Fixed asset basis difference

 

 

 

 

 

 

Net operating loss carry forwards

 

 

21,293

 

 

 

19,526

 

Gross deferred tax assets

 

$

26,903

 

 

$

24,250

 

Fixed asset basis difference

 

$

(2,237

)

 

$

(90

)

Operating lease right-of-use assets

 

$

(4,089

)

 

$

(3,409

)

Gross deferred tax liabilities

 

$

(6,326

)

 

$

(3,499

)

Net deferred tax asset

 

$

20,577

 

 

$

20,751

 

Valuation allowance

 

 

(21,795

)

 

 

(20,514

)

Net deferred taxes

 

$

(1,218

)

 

$

237

 

The balance sheet classification of deferred tax is as follows:

 

 

December 31,

2020

 

 

March 31,

2020

 

Net noncurrent deferred tax assets

 

$

237

 

 

$

237

 

Net noncurrent deferred tax liabilities

 

$

(1,455

)

 

$

 

Total

 

$

(1,218

)

 

$

237

 

The following table summarizes the activity related to the Company’s uncertain tax positions (excluding interest and penalties and related tax attributes):

 

 

Quarter ended December 31,

 

 

Nine months ended December 31,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Balance at beginning of period

 

$

1,216

 

 

$

 

 

$

1,216

 

 

$

 

Increases related to current year  tax positions

 

 

 

 

 

 

 

 

 

 

 

 

Increases related to prior years tax positions

 

 

 

 

 

 

 

 

 

 

 

 

Balance at end of period

 

$

1,216

 

 

$

 

 

$

1,216

 

 

$

 

As of December 31, 2020, the Company has an unrecognized benefit of $1,216, that if recognized would be recorded as a component of tax expense. The Company’s unrecognized tax benefits include exposures related to positions taken on income tax returns in all jurisdictions. The Company has interest expense carryforward from March 31, 2017 that potentially would be disqualified as interest expense in the amount of $613. Additionally, the Company has reassessed its transfer pricing policies in certain jurisdictions from 2015 to 2017, the impact of which is $603. In the normal course of business, the Company’s tax returns are subject to examination by various taxing authorities. Such examinations may result in future tax and interest assessments by these taxing authorities and the Company has accrued a liability when it believes it is more likely than not that the tax position claimed on tax returns will continue to monitornot be sustained by the position regardingtaxing authorities on the effectivenesstechnical merits of the election to transferposition. Changes in the allowancesrecognition of the liability are reflected in order to determine whether the deferred tax liability should be recorded.  period in which the change in judgment occurs.

- 23 -


 

 

Note 10. Defined Benefit Pension Plans

The Company’s Swiss subsidiary has a fully insured pension plan managed by Swiss Life. The costs of this plan were:

 

 

Quarter ended

 

 

Nine months ended

 

 

Quarter ended

 

 

Nine months ended

 

 

December 31,

 

 

December 31,

 

 

December 31,

 

 

December 31,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Employer service cost

 

$

456

 

 

$

388

 

 

$

1,362

 

 

$

1,183

 

 

$

620

 

 

$

456

 

 

$

1,818

 

 

$

1,362

 

Interest cost

 

 

31

 

 

 

38

 

 

 

93

 

 

 

115

 

 

 

33

 

 

 

31

 

 

 

95

 

 

 

93

 

Expected return on plan assets

 

 

(32

)

 

 

(32

)

 

 

(94

)

 

 

(98

)

 

 

(62

)

 

 

(32

)

 

 

(183

)

 

 

(94

)

Amortization of prior service credit

 

 

(6

)

 

 

(4

)

 

 

(17

)

 

 

(11

)

 

 

13

 

 

 

(6

)

 

 

40

 

 

 

(17

)

Amortization of net loss

 

 

54

 

 

 

38

 

 

 

161

 

 

 

116

 

 

 

 

 

 

54

 

 

 

 

 

 

161

 

Net pension cost

 

$

503

 

 

$

428

 

 

$

1,505

 

 

$

1,305

 

 

$

604

 

 

$

503

 

 

$

1,770

 

 

$

1,505

 

 

The employer contributions for the nine month periods ended December 31, 20192020 and December 31, 20182019 were $954$995 and $852,$954, respectively.  The estimated employer contributions for the fiscal year ending March 31, 20202021 are $1,208.$1,255.

- 21 -


 

Note 11. Net Loss Per Share

In accordance with Accounting Standards Codification Topic 260 “Earnings Per Share”, basic earnings available to ordinary shareholders per share is computed based on the weighted average number of ordinary shares outstanding during each period. Diluted earnings available to ordinary shareholders per share is computed based on the weighted average number of ordinary shares outstanding during each period, plus potential ordinary shares considered outstanding during the period, as long as the inclusion of such shares is not anti-dilutive. Potential ordinary shares consist of the incremental ordinary shares issuable upon the exercise of share options (using the treasury shares method), the warrants to acquire ordinary shares and the ordinary shares issuable upon vesting of the MRSUs and RSUs.

The following table sets forth the computation of basic and diluted earningsloss per ordinary share:

 

 

Quarter ended

 

 

Nine months ended

 

 

Quarter ended

 

 

Nine months ended

 

 

December 31,

 

 

December 31,

 

 

December 31,

 

 

December 31,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(27,485

)

 

$

(26,254

)

 

$

(78,046

)

 

$

(78,792

)

 

$

(29,757

)

 

$

(27,485

)

 

$

(70,161

)

 

$

(78,046

)

Net loss available to ordinary

shareholders - basic and diluted

 

$

(27,485

)

 

$

(26,254

)

 

$

(78,046

)

 

$

(78,792

)

 

$

(29,757

)

 

$

(27,485

)

 

$

(70,161

)

 

$

(78,046

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares

outstanding - basic and diluted

 

 

73,768,845

 

 

 

56,619,356

 

 

 

68,722,475

 

 

 

51,512,352

 

 

 

101,016,040

 

 

 

73,768,845

 

 

 

88,512,823

 

 

 

68,722,475

 

Loss per share - basic and diluted

 

$

(0.37

)

 

$

(0.46

)

 

$

(1.14

)

 

$

(1.53

)

 

$

(0.29

)

 

$

(0.37

)

 

$

(0.79

)

 

$

(1.14

)

 

The following table sets out the numbers of ordinary shares excluded from the above computation of earnings per share at December 31, 20192020 and December 31, 20182019 as their inclusion would have been anti-dilutive:

 

 

 

December 31,

2019

 

 

December 31,

2018

 

Ordinary shares issuable on exercise of options to purchase

   ordinary shares

 

 

1,859,979

 

 

 

2,241,223

 

Restricted share units awarded, including the multi-year

   performance related restricted share units

 

 

781,839

 

 

 

1,085,752

 

Ordinary shares issuable on exercise of warrants at $16.14 per

   share

 

 

111,525

 

 

 

111,525

 

Ordinary shares issuable on exercise of warrants at $9.375 per

   share

 

 

64,000

 

 

 

64,000

 

Ordinary shares issuable on exercise of warrants at $0.01 per

   share

 

 

 

 

 

550,000

 

 

 

 

2,817,343

 

 

 

4,052,500

 

 

 

December 31,

2020

 

 

December 31,

2019

 

Ordinary shares issuable on exercise of options to purchase ordinary shares

 

 

1,965,260

 

 

 

1,859,979

 

Restricted share units awarded

 

 

994,037

 

 

 

781,839

 

Ordinary shares issuable on exercise of warrants at $16.14 per

   share

 

 

111,525

 

 

 

111,525

 

Ordinary shares issuable on exercise of warrants at $9.375 per

   share

 

 

64,000

 

 

 

64,000

 

 

 

 

3,134,822

 

 

 

2,817,343

 

 

 

- 24 -


12. Lease Commitments

 

The Company has operating lease commitments for real estate and certain equipment in the United States, the United Kingdom, the Republic of Ireland and Switzerland. There are no0 sublease agreements in place. The Company has finance lease commitments for equipment in the United Kingdom and Switzerland.

 

The Company leases an 87,200 square foot conventional reagents manufacturing facility, with integrated offices and laboratories, in Edinburgh, Scotland. This lease commenced in March 2018, following completion of a sale and leaseback transaction, and expires in September 2052. Rent is recognized in the consolidated statement of comprehensive loss on a straight-line basis over the lease term. Additionally, the lease required the Company to provide a rent deposit of £3.6 million which amounted to $4.7$4.9 million at December 31, 20192020 and $4.7$4.4 million at March 31, 2019,2020 and is included within other non-current assets in the consolidated balance sheets. In March 2015 the Company signed a five-year lease agreement for its corporate headquarters and MosaiQ manufacturing facility in Eysins, Switzerland. This lease was extended for a further five-year period to March 14, 2025. The Company also leases office space for commercial and development activities under one to three-year lease agreements in Newtown PA, Chapel Hill NC and Dublin, Republic of Ireland.

 

- 22 -


The operating lease commitments relating to equipment are not material. The finance lease commitments relate to specialized equipment required for manufacturing operations in both Edinburgh, Scotland and Eysins, Switzerland.  

 

Many of the Company’s leases contain options to renew and extend lease terms and options to terminate leases early. Reflected in the right-of-use asset and lease liability on the Company’s balance sheet are the periods provided by renewal and extension options that the Company is reasonably certain to exercise, as well as the periods provided by termination options that the Company is reasonably certain not to exercise. The Company does not have any existing lease agreements with variable lease components.

 

In calculating the present value of future lease payments, the Company has elected to utilize itsan incremental borrowing rate based on the remaining lease term at the date of adoption. Incremental borrowing rates are the rates incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company has elected to account for each lease component and its associated non-lease component as a single lease component and has allocated all the contract consideration across the lease component only. There are no material non-lease components. As of December 31, 2019,2020, an operating lease right-of-use asset of $22,798$22,364 and an operating lease liability of $24,296$24,512 (including a current portion of $3,157)$3,309) were reflected on the condensed consolidated balance sheet. As of March 31, 2020, an operating lease right-of-use asset of $21,493 and an operating lease liability of $22,947 (including a current portion of $3,033) were reflected on the condensed consolidated balance sheet. As of December 31, 2019,2020, the Company had entered into finance leases for the purchase of plant and equipment that had net book values of $1,975.$1,591. An associated finance lease liability of $1,472$1,460 (including a current portion of $522)$878) was reflected on the condensed consolidated balance sheet. As of March 31, 2020, the Company had entered into finance leases for the purchase of plant and equipment that had net book values of $2,216. An associated finance lease liability of $1,715 (including a current portion of $598) was reflected on the condensed consolidated balance sheet.  

 

The elements of lease expense were as follows:

 

 

Quarter ended December 31,

 

 

Nine months ended December 31,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Lease cost

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease cost

 

$

1,133

 

 

$

950

 

 

$

3,262

 

 

$

2,760

 

Finance lease cost

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of right-of-use asset

 

 

298

 

 

 

230

 

 

 

814

 

 

 

565

 

Interest on lease liabilities

 

 

28

 

 

 

29

 

 

 

99

 

 

 

84

 

Short-term lease cost

 

 

18

 

 

 

18

 

 

 

52

 

 

 

52

 

Total lease cost

 

$

1,477

 

 

$

1,227

 

 

$

4,227

 

 

$

3,461

 

- 25 -


 

 

 

Quarter ended

 

 

Nine months ended

 

 

 

December 31, 2019

 

 

December 31, 2019

 

Operating lease cost

 

$

950

 

 

$

2,760

 

Finance lease cost

 

 

 

 

 

 

 

 

Amortization of right-of-use asset

 

 

230

 

 

 

565

 

Interest on lease liabilities

 

 

29

 

 

 

84

 

Short-term lease cost

 

 

18

 

 

 

52

 

Total lease cost

 

$

1,227

 

 

$

3,461

 

 

Other information related to leases was as follows:

 

Supplemental cash flow information

 

Nine months ended December 31,

 

 

Nine months ended

December 31, 2019

 

 

2020

 

 

2019

 

Cash paid for amounts included in the measurement of lease liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Operating leases - operating cash flows

 

$

2,270

 

 

$

2,806

 

 

$

2,270

 

Finance leases - finance cash flows

 

$

337

 

Finance leases - financing cash flows

 

$

490

 

 

$

337

 

Finance leases - operating cash flows

 

$

84

 

 

$

99

 

 

$

84

 

Non-cash leases activity

 

 

 

 

 

 

 

 

 

 

 

 

Right-of-use assets obtained in exchange for new operating lease liabilities

 

$

5,160

 

 

$

56

 

 

$

5,160

 

Right-of-use assets obtained in exchange for new finance lease liabilities

 

$

487

 

 

$

130

 

 

$

487

 

Lease term and discount rate

 

 

As at

of December 31, 2019

2020

 

Weighted average remaining lease terms (in years)

 

 

 

 

Operating leases

 

30.229.6

 

Finance leases

 

2.2

1.8

 

Weighted average discount rate

 

 

 

 

Operating leases

 

 

10.110.9

%

Finance leases

 

 

5.89.1

%

 

- 23 -


 

Future lease payments required under non-cancellable operating leases in effect as of December 31, 2019 were as follows:

 

 

December 31,

2020

 

 

March 31,

2020

 

2021 (excluding the nine months ended December 31, 2020)

 

$

927

 

 

$

3,335

 

2022

 

 

3,674

 

 

 

3,319

 

2023

 

 

3,370

 

 

 

3,050

 

2024

 

 

3,360

 

 

 

3,055

 

2025

 

 

3,409

 

 

 

3,105

 

Thereafter

 

 

72,959

 

 

 

66,138

 

Total lease payments

 

$

87,699

 

 

$

82,002

 

Less : imputed interest

 

 

(63,187

)

 

 

(59,055

)

Total operating lease liabilities

 

$

24,512

 

 

$

22,947

 

 

 

 

December 31,

2019

 

2020 (excluding the nine months ended December 31, 2019)

 

$

897

 

2021

 

 

3,441

 

2022

 

 

3,426

 

2023

 

 

3,159

 

2024

 

 

3,164

 

Thereafter

 

 

73,695

 

Total lease payments

 

$

87,782

 

Less : imputed interest

 

 

(63,486

)

Total operating lease liabilities

 

$

24,296

 

 

Future lease payments required under finance leases in effect as of December 31, 2019 were as follows:

 

December 31,

2019

 

 

December 31,

2020

 

 

March 31,

2020

 

2020 (excluding the nine months ended December 31, 2019)

 

$

179

 

2021

 

 

578

 

2021 (excluding the nine months ended December 31, 2020)

 

$

185

 

 

$

720

 

2022

 

 

690

 

 

 

958

 

 

 

838

 

2023

 

 

207

 

 

 

423

 

 

 

349

 

2024

 

 

3

 

 

 

45

 

 

 

7

 

Thereafter

 

 

 

2025

 

 

13

 

 

 

 

Total lease payments

 

$

1,657

 

 

$

1,624

 

 

$

1,914

 

Less : imputed interest

 

 

(185

)

 

 

(164

)

 

 

(199

)

Total finance lease liabilities

 

$

1,472

 

 

$

1,460

 

 

$

1,715

 

 

The Company adopted ASU 2016-02 on April 1, 2019 and, as required, the following disclosure is provided for periods prior to adoption. Future minimum lease payments required under non-cancellable operating leases in effect as of March 31, 2019 were as follows:

 

 

March 31,

2019

 

2020

 

$

3,387

 

2021

 

 

1,861

 

2022

 

 

1,858

 

2023

 

 

1,830

 

2024

 

 

1,841

 

Thereafter

 

 

71,507

 

Total minimum future lease payments

 

$

82,284

 

Future annual lease payments required under finance leases in effect as of March 31, 2019 were as follows:

 

 

March 31,

2019

 

2020

 

 

471

 

2021

 

 

369

 

2022

 

 

306

 

2023

 

 

190

 

Thereafter

 

 

 

Total minimum future lease payments

 

$

1,336

 

- 24 -


13. Subsequent events

On January 3, 2020 the Company entered into a transition, separation and consultancy agreement with Christopher J. Lindop, its Chief Financial Officer. Under this agreement Mr. Lindop will resign his position as Chief Financial Officer with effect from February 5, 2020, and serve as an Executive Vice President until his retirement on May 31, 2020. Certain transitional benefit payments will be made to Mr. Lindop under the terms of his agreement. Peter Buhler will be appointed as Chief Financial Officer, effective as of February 5, 2020.

 

 

 

- 2526 -


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the corresponding section of our Annual Report on Form 10-K for the year ended March 31, 20192020 filed with the SEC on May 29, 2019.June 12, 2020.

The information set forth and discussed below for the quarters and nine month periods ended December 31, 20192020 and December 31, 20182019 is derived from the condensed consolidated financial statements included under Part I, Item 1 “Financial Statements” above. The financial information set forth and discussed below is unaudited but includes all adjustments (consisting of normal recurring adjustments) that our management considers necessary for a fair presentation of the financial position and the operating results and cash flows for those periods. Our results of operations for a particular quarter may not be indicative of the results that may be expected for other quarters or the entire year.

In addition to historical financial information, the following discussion contains forward looking statements that reflect our plans, estimates, beliefs and expectations that involve risks and uncertainties. Our actual results and the timing of events could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report, and our Annual Report on Form 10-K for the year ended March 31, 2019,2020, particularly in “Risk Factors.”

Overview

We were incorporated in Jersey, Channel Islands on January 18, 2012. On February 16, 2012, we acquired the entire issued share capital of Alba Bioscience Limited (or Alba), Quotient Biodiagnostics, Inc. (or QBDI) and QBD (QSIP) Limited (or QSIP) from Quotient Biodiagnostics Group Limited (or QBDG), our predecessor.

Our Business

We are a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. Our initial focus is on blood grouping and donor disease screening, which is commonly referred to as transfusion diagnostics. Blood grouping involves specific procedures performed at donor or patient testing laboratories to characterize blood, which includes antigen typing and antibody detection. Disease screening involves the screening of donor blood for unwanted pathogens using two different methods, a serological approach (testing for specific antigens or antibodies) and a molecular approach (testing for DNA or RNA).

We have over 3035 years of experience developing, manufacturing and commercializing conventional reagent products used for blood grouping within the global transfusion diagnostics market. We are developing MosaiQ, our proprietary technology platform, to better address the comprehensive needs of this large and established market. We believe MosaiQ has the potential to transform transfusion diagnostics, significantly reducing the cost of blood grouping in the donor and patient testing environments, while improving patient outcomes.

In addition, in response to the global COVID-19 pandemic, in May 2020, we completed development of a microarray-based SARS-CoV-2 antibody test for use on the MosaiQ platform. The SARS-CoV-2 antibody test is designed as a serological disease screen specific to COVID-19 antibody detection. The assay detects the Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies directed at SARS-CoV-2. We refer to the SARS-CoV-2 antibody test as the MosaiQ COVID-19 Microarray.

We currently operate as one business segment with 420439 employees in the United Kingdom, Switzerland and the United States, as of December 31, 2019.2020. Our principal markets are the United States, Europe and Japan. Based on the location of the customer, revenues outside the United States accounted for 44%30% of total revenue during the nine month ended December 31, 2019 and 50% during the nine month period ended December 31, 2018.2020 and 44% during the nine month period ended December 31, 2019.

We have incurred net losses and negative cash flows from operations in each year since we commenced operations in 2007. As of December 31, 2019,2020, we had an accumulated deficit of $458.7$553.6 million. We expect our operating losses to continue for at least the remainder of the currentfinancial year ending March 31, 2021 as we continue our investment in the commercialization of MosaiQ. For the nine month period ended December 31, 2019,2020, our total revenue was $24.0$33.7 million and our net loss was $78.0$70.2 million.

- 2627 -


 

From our incorporation in 2012 to March 31, 2019,2020, we have raised $160.0 million of gross proceeds through the private placement of our ordinary and preference shares and warrants, $250.1$346.7 million of gross proceeds from public offerings of our shares and issuances of ordinary shares upon exercise of warrants and $120.0$145.0 million of gross proceeds from the issuance of 12% Senior Secured Notes, or the “Secured Notes”.

On May 15, 2019, we issued an additional $25.0 million aggregate principal amount of the Secured Notes. On May 15, 2019, we paid $1.5 million of the net proceeds of the issuance into the cash reserve account maintained with the collateral agent under the terms of the indenture governing the Secured Notes, which together with the $7.2 million paid into the cash reserve account in respect of previous issuances, brought the total in the cash reserve account to $8.7 million at December 31, 2019.

On November 12, 2019,September 15, 2020, we completed a public offering of 13,800,00020,294,117 newly issued ordinary shares at a price of $7.00$4.25 per share which raised $96.6$86.3 million of gross proceeds before underwriting discounts and other offering expenses.expenses of $5.6 million.

As of December 31, 2019,2020, we had available cash, cash equivalents and short-term investments of $138.0$134.5 million and $9.0 million of restricted cash held as part of the arrangements relating to our Secured Notes and the lease of our property in Eysins, Switzerland.

Regulatory and Commercial Milestones

You should read the following regulatory and commercial milestones update in conjunction with the discussion included under the sections “Item 1. Business” and “Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended March 31, 20192020 filed with the SEC on May 29, 2019.June 12, 2020.

 

Initial European Regulatory Approval– we filed for European regulatory approval for our initial MosaiQ Immunohematology, or “IH”, microarray in late September 2018 and were notified of its approval on April 30, 2019.

Initial European Regulatory Approval– we filed for European regulatory approval for our initial MosaiQ IH Microarray in late September 2018 and were notified of its approval on April 30, 2019. We also filed for European regulatory approval of the initial MosaiQ SDS Microarray in June 2019 and were notified of its approval on February 14, 2020.

European Hyper-Care Launch– following the CE mark for our initial IH microarray, we have commenced a hyper-care launch with four of ten selected customers.

European and U.S. Hypercare Launch– following the CE mark for our initial MosaiQ IH Microarray, we have commenced and completed hypercare testing with four selected customers.

Ongoing Microarray Menu Development– our activities for the expansion of our IH and Serological Disease Screening, or “SDS”, testing menus included the completion of the validation and verification, or “V&V”, concordance study for the expanded IH microarray menu, which we announced in October 2019. The V&V study for the expanded SDS microarray is planned for the second quarter of calendar year 2020.

Ongoing Microarray Menu Development– our activities for the expansion of our IH and SDS, testing menus included the completion of the validation and verification, or “V&V”, concordance study for the expanded MosaiQ IH Microarray menu, which we announced in October 2019. The V&V study for the expanded MosaiQ SDS Microarray is planned for the coming months.

Field Trials– we commenced the European field trial activities with our expanded IH microarray menu in the first quarter of calendar year 2020, with U.S. field trial activity expected to follow thereafter. We have completed U.S. field trial activity for our initial SDS microarray and expect to commence European and U.S. field trial activities for our expanded SDS microarray in the second half of calendar year 2020.

Field Trials– we commenced field trials for the expanded MosaiQ IH Microarray in Europe in the first quarter of calendar year 2020. These trials were initially suspended due to the COVID-19 pandemic in March 2020, but by the end of May 2020, quarantine and containment measures and restrictions had eased in all three trial locations allowing the work to recommence. However, subsequent governmental restrictions implemented towards the end of 2020 have impacted our ability to conduct these trials, as discussed below. We announced the initial results from these trials in November 2020. Based on our internal performance testing, we subsequently determined to enhance a limited number of the tests on the expanded MosaiQ IH Microarray. The commencement of field trials in the United States for the expanded MosaiQ IH Microarray has also been postponed due to the COVID-19 pandemic. We expect these trials to commence in the second quarter of calendar year 2021. We expect field trials for the expanded MosaiQ SDS Microarray to commence towards the end of calendar year 2021.

Ongoing Regulatory Approval Process– we filed for U.S. regulatory approval for our initial MosaiQ SDS Microarray on December 23, 2019. On December 10, 2020, we received a request from the FDA for additional testing data related to specific individual performance characteristics of the assays on this microarray. We anticipate that we will resubmit our filing and receive 510(k) clearance for the initial MosaiQ SDS Microarray during the first half of calendar year 2021. We expect to make the initial European regulatory submissions for our expanded MosaiQ IH Microarray during the second quarter of calendar year 2021, with the U.S. regulatory submissions following in the fourth quarter of calendar year 2021. We expect to receive the CE mark for the expanded MosaiQ IH Microarray by the fourth quarter of calendar year 2021. We expect to make a European regulatory submission for the expanded MosaiQ SDS Microarray in the second quarter of calendar year 2022, with the U.S. regulatory submission following in the second or third quarter of calendar year 2022.

Ongoing Regulatory Approval Process– we completed a CE mark submission for the initial SDS microarray on June 30, 2019.  We filed for U.S. regulatory approval for our initial SDS microarray on December 23, 2019. Initial European regulatory submissions for our expanded IH microarray are expected during the first half of calendar year 2020 with US regulatory submissions following later in the calendar year 2020. European regulatory submission for the expanded SDS microarray is expected in the second half of calendar year 2020.

Patient IH Microarray – we are developing for Ortho-Clinical Diagnostics Inc. (or Ortho), a dedicated MosaiQ IH Microarray optimized for the patient transfusion market (which we refer to as the MosaiQ IH3 Microarray), and we expect to submit it for CE mark in the first half of calendar year 2022.

Ortho Distribution and Supply Agreement

COVID-19 Pandemic

You should read the following COVID-19 pandemic update regarding our distribution and supply agreement with Ortho Clinical Diagnostics, Inc. (or Ortho) in conjunction with the discussion included under the sections “Item 1. Business” and “Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended March 31, 20192020 filed with the SEC on May 29, 2019.June 12, 2020.

- 2728 -


 

We were party to

On March 11, 2020, the World Health Organization declared the novel strain of coronavirus (COVID-19) a distributionglobal pandemic and supply agreement with Ortho to sellrecommended containment and distribute MosaiQ Microarraysmitigation measures worldwide. The governments of each of the major locations in certain markets, which we referoperate, the United Kingdom, Switzerland and the United States, have implemented varying measures and restrictions to ascombat the Ortho Agreement. On November 27, 2019, we delivered a notice to Ortho that we had terminatedCOVID-19 pandemic.

The restrictions implemented at the Ortho Agreement, effective as of December 27, 2019.  We had not realized any revenue under the Ortho Agreement prior to its termination.  

Ortho has initiated an arbitration proceeding in which it seeks a declaration that we do not have the right to terminate the Ortho Agreement, specific performance of certain provisionsbeginning of the Ortho Agreement, and damages.  We are pursuing counterclaims against Ortho, includingpandemic directly impacted our on-going clinical trials for damages.  In addition, on December 20, 2019, we entered into an agreement, or the Ortho Dispute Agreement, with Ortho pursuant to which we agreed, while the arbitration is pending, not to enter into any commercialization agreement in respect of products that overlap with Ortho’s rights under the Ortho Agreement without prior written notice to Ortho.  We believe that Ortho’s allegations are without merit and we intend to defend ourselves vigorously against Ortho’s claims. However, because of the uncertainties inherent in all dispute resolution proceedings, we cannot predict with certainty whether we will prevail on our defenses and counterclaims or the impact this arbitration may have on our business, results of operations or financial condition, including our conventional reagent business with Ortho.

Our initial MosaiQ IH Microarray and our second, expanded MosaiQ IH Microarray are being developed for the donor testing market, with our initial focus being onin Europe and the United States, whilecommencement of clinical trials for our thirdexpanded MosaiQ IH Microarray is being developedin the United States. All external work on these trials was suspended in March 2020 until such time as the existing restrictions in the relevant jurisdictions are removed or moderated. By the end of May 2020, quarantine and containment measures and restrictions had eased in all of the three European trial locations allowing the work to recommence.

In addition, on April 6, 2020, we announced the completion of the development phase of the MosaiQ COVID-19 Microarray, in response to the COVID-19 pandemic. On April 27, 2020, we published the final performance data for the patient testing market. UnderMosaiQ COVID-19 Microarray, achieving 100% sensitivity and 99.8% specificity, and on May 1, 2020, we announced the Ortho Agreement, Ortho had rightsCE Mark for this Microarray. In addition, in May 2020, we submitted an application to distributethe FDA for an Emergency Use Authorization (EUA) of the MosaiQ IH MicroarraysCOVID-19 Microarray in the patient testing marketUnited States, and in September 2020, we announced the EUA had been issued by the FDA for this Microarray. We signed the first commercial contract for the sale of the MosaiQ COVID-19 Microarray in May 2020, and we have subsequently entered into nine additional contracts with customers in Europe and the United States.  While our dispute with OrthoIn addition, we developed an enhanced, semi-quantitative MosaiQ COVID-19 Microarray, which has been ongoing,CE marked as of January 29, 2021 and for which we intend to submit an FDA EUA application in February 2021.

Since October 2020, there has been a widespread increase, or "second wave," in reported infections from COVID-19, including in Europe and the United States. In response, various countries including in Europe have announced the re-imposition of some restrictions on social, business and other activities. Government travel restrictions and lockdowns imposed in response to the second wave seriously affected our operations in Europe and the United Kingdom.  

In spite of this widespread increase of COVID-19 infections, the COVID-19 pandemic and the associated restrictions have not pursued alternativeshad a material adverse impact on our conventional reagent revenues. Customer demand has remained robust since March 31, 2020 and, to date, supply chain disruptions have been minimal. Our manufacturing operations in Edinburgh, Scotland have been adapted to meet social distancing requirements, which impacted our operating costs during the nine month period ended December 31, 2020.

However, the second wave has negatively affected the on-going field trials for commercializing our expanded MosaiQ IH MicroarraysMicroarray, with travel restrictions and lockdowns making it difficult for relevant teams to spend time on-site and resulting in trials repeatedly stopping and restarting. Furthermore, these restrictions and lockdowns have impacted our research and development activities, slowed down the patient testing market.regulatory approval process and delayed the timing of customer tenders.

The extent to which the COVID-19 pandemic will impact our business, operations and financial results will depend on future developments and numerous evolving factors, which are highly uncertain and difficult to predict.

Revenue

We generate product sales revenue from the sale of conventional reagent products directly to hospitals, donor collection agencies and independent testing laboratories in the United States, the United Kingdom and to distributors in Europe and the rest of the world, and indirectly through sales to our original equipment manufacturer (or OEM) customers. We recognize revenues in the form of product sales when the goods are shipped. Products sold by standing purchase orders as a percentage of product sales revenue were 71%69% and 67%71% for the nine month periods ended December 31, 20192020 and December 31, 2018,2019, respectively. We also provide product development services to our OEM customers. We recognize revenue from these contractual relationships in the form of product development fees, which are included in other revenues. In addition, during the nine month period ended December 31, 2020, we began to generate sales revenue from the MosaiQ COVID-19 Microarray in Europe and the United States, and our product sales from this microarray were approximately $1 million during this period. Although we anticipate that these product sales will continue for the next three to six months, we believe there is ultimately a limited opportunity for future revenue from our MosaiQ COVID-19 Microarray beyond that timeframe, based on the limited demand for COVID-19 antibody testing that we are observing. For a description of our revenue recognition policies, see “—Critical Accounting Policies and Significant Judgments and Estimates—Revenue Recognition and Accounts Receivable.”

- 29 -


Our revenue is denominated in multiple currencies. Sales in the United States and to certain of our OEM customers are denominated in U.S. Dollars. Sales in Europe and the rest of the world are denominated primarily in U.S. Dollars, Pounds Sterling or Euros. Our expenses are generally denominated in the currencies in which our operations are located, which are primarily in the United Kingdom, Switzerland and the United States. We operate globally and therefore changes in foreign currency exchange rates may become material to us in the future due to factors beyond our control. See “—Quantitative and Qualitative Disclosure About Market Risk—Foreign Currency Exchange Risk.”

Cost of revenue and operating expenses

Cost of revenue consists of direct labor expenses, including employee benefits, overhead expenses, material costs and freight costs, along with the depreciation of manufacturing equipment and leasehold improvements. Our gross profit represents total revenue less the cost of revenue, gross margin represents gross profit expressed as a percentage of total revenue, and gross margin on product sales represents gross margin excluding other revenues as a percentage of revenues excluding other revenues. We expect our overall cost of revenue to increase in absolute U.S. Dollars as we continue to increase our product sales volumes. However, we also believe that we can achieve efficiencies in our manufacturing operations, primarily through increasing production volumes.

- 28 -


Our sales and marketing expenses include costs associated with our sales organization for conventional reagent products, including our direct sales force, as well as our marketing and customer service personnel and the costs of the MosaiQ commercial team. These expenses consist principally of salaries, commissions, bonuses and employee benefits, as well as travel and other costs related to our sales and product marketing activities. We expense all sales and marketing costs as incurred. We expect sales and marketing expense to increase in absolute U.S. Dollars, primarily as a result of commissions on increased product sales in the United States and as we grow the MosaiQ commercial team.

Our research and development expenses include costs associated with performing research, development, field trials and our regulatory activities, as well as production costs incurred in advance of the commercial launch of MosaiQ. Research and development expenses include research personnel-related expenses, fees for contractual and consulting services, travel costs, laboratory supplies and depreciation of laboratory equipment.

We expense all research and development costs as incurred, net of government grants received and tax credits. Our UK subsidiary claims certain tax credits on its research and development expenditures and these are included as an offset to our research and development expenses. Our research and development efforts are focused on developing new products and technologies for the global transfusion diagnostics market. We segregate research and development expenses for the MosaiQ project from expenses for other research and development projects. We do not maintain detailed records of these other costs by activity. We are nearing completion of the initial development of MosaiQ and expect our costs associated with field trials and regulatory approvals will increase at the same time as our development costs decrease. As we move to commercialization of MosaiQ in the donor testing market, we expect our overall research and development expense to decrease.

Our general and administrative expenses include costs for our executive, accounting and finance, legal, corporate development, information technology and human resources functions. We expense all general and administrative expenses as incurred. These expenses consist principally of salaries, bonuses and employee benefits for the personnel performing these functions, including travel costs. These expenses also include share-based compensation, professional service fees (such as audit, tax and legal fees), costs related to our Board of Directors, and general corporate overhead costs, which include depreciation and amortization. We expect our general and administrative expenses to increase as our business develops and also due to the costs of operating as a public company, such as additional legal, accounting and corporate governance expenses, including expenses related to compliance with the Sarbanes-Oxley Act, directors’ and officers’ insurance premiums and investor relations expenses.

Net interest expense consists primarily of interest charges on our Secured Notes and the amortization of debt issuance costs (which includes amortization of the one-time consent payment of $3.9 million paid to holders of our Secured Notes in December 2018), as well as accrued dividends on the 7% cumulative redeemable preference shares issued in January 2015. We amortize debt issuance costs over the life of the Secured Notesinstrument and report them as interest expense in our statements of operations. Net interest also includes the expected costs of the royalty rights agreements we entered into in October 2016, June 2018, December 2018 and May 2019 with the purchasers and consenting note holders, as applicable, of our Secured Notes. See Note 4, “Debt” and Note 7, “Ordinary and Preference Shares – Preference shares” to our condensed consolidated financial statements included in this Quarterly Report for additional information.

Other income (expense), net consists primarily of exchange fluctuations. These include realized exchange fluctuations resulting from the settlement of transactions in currencies other than the functional currencies of our businesses. Monetary assets and liabilities that are denominated in foreign currencies are measured at the period-end closing rate with resulting unrealized exchange fluctuations. The functional currencies of our businesseslegal entities are Pounds Sterling, Swiss Francs and U.S. Dollars depending on the entity.

Provision- 30 -


As discussed in more detail below, provision for income taxes in the nine month period ended December 31, 2019 reflects a reduction in2020 reflected the net operating losses available to be carried forward intaxes payable on the taxable income of a subsidiary asand the resolution of a resultmajor tax uncertainty related to the treatment of the offset of historiccertain tax losses against the profits of this subsidiary.depreciation allowances.

- 29 -


Results of Operations

Comparison of the Quarters ended December 31, 20192020 and 20182019

The following table sets forth, for the periods indicated, the amounts of certain components of our statements of operations and the percentage of total revenue represented by these items, showing period-to-period changes.

 

 

Quarter ended December 31,

 

 

 

 

 

 

 

 

 

 

Quarter ended December 31,

 

 

 

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

 

 

2020

 

 

2019

 

 

Change

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

(in thousands, except percentages)

 

 

(in thousands, except percentages)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

7,636

 

 

 

96

%

 

$

6,723

 

 

 

100

%

 

$

913

 

 

 

14

%

 

$

8,740

 

 

 

100

%

 

$

7,636

 

 

 

96

%

 

$

1,104

 

 

 

14

%

Other revenues

 

 

305

 

 

 

4

%

 

 

 

 

 

0

%

 

 

305

 

 

 

 

 

 

11

 

 

 

0

%

 

 

305

 

 

 

4

%

 

 

(294

)

 

 

-96

%

Total revenue

 

 

7,941

 

 

 

100

%

 

 

6,723

 

 

 

100

%

 

 

1,218

 

 

 

18

%

 

 

8,751

 

 

 

100

%

 

 

7,941

 

 

 

100

%

 

 

810

 

 

 

10

%

Cost of revenue

 

 

4,532

 

 

 

57

%

 

 

4,186

 

 

 

62

%

 

 

346

 

 

 

8

%

 

 

4,970

 

 

 

57

%

 

 

4,532

 

 

 

57

%

 

 

438

 

 

 

10

%

Gross profit

 

 

3,409

 

 

 

43

%

 

 

2,537

 

 

 

38

%

 

 

872

 

 

 

34

%

 

 

3,781

 

 

 

43

%

 

 

3,409

 

 

 

43

%

 

 

372

 

 

 

11

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

2,290

 

 

 

29

%

 

 

2,233

 

 

 

33

%

 

 

57

 

 

 

3

%

 

 

2,283

 

 

 

26

%

 

 

2,290

 

 

 

29

%

 

 

(7

)

 

 

0

%

Research and development

 

 

14,160

 

 

 

178

%

 

 

11,788

 

 

 

175

%

 

 

2,372

 

 

 

20

%

 

 

14,485

 

 

 

166

%

 

 

14,160

 

 

 

178

%

 

 

325

 

 

 

2

%

General and administrative

 

 

9,316

 

 

 

117

%

 

 

7,544

 

 

 

112

%

 

 

1,772

 

 

 

23

%

 

 

8,738

 

 

 

100

%

 

 

9,316

 

 

 

117

%

 

 

(578

)

 

 

-6

%

Total operating expenses

 

 

25,766

 

 

 

324

%

 

 

21,565

 

 

 

321

%

 

 

4,201

 

 

 

19

%

 

 

25,506

 

 

 

291

%

 

 

25,766

 

 

 

324

%

 

 

(260

)

 

 

-1

%

Operating loss

 

 

(22,357

)

 

 

-282

%

 

 

(19,028

)

 

 

-283

%

 

 

(3,329

)

 

 

17

%

 

 

(21,725

)

 

 

-248

%

 

 

(22,357

)

 

 

-282

%

 

 

632

 

 

 

-3

%

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(7,008

)

 

 

-88

%

 

 

(5,679

)

 

 

-84

%

 

 

(1,329

)

 

 

23

%

 

 

(6,753

)

 

 

-77

%

 

 

(7,008

)

 

 

-88

%

 

 

255

 

 

 

-4

%

Other, net

 

 

1,894

 

 

 

24

%

 

 

(1,536

)

 

 

-23

%

 

 

3,430

 

 

 

-223

%

 

 

192

 

 

 

2

%

 

 

1,894

 

 

 

24

%

 

 

(1,702

)

 

 

-90

%

Total other expense, net

 

 

(5,114

)

 

 

-64

%

 

 

(7,215

)

 

 

-107

%

 

 

2,101

 

 

 

-29

%

 

 

(6,561

)

 

 

-75

%

 

 

(5,114

)

 

 

-64

%

 

 

(1,447

)

 

 

28

%

Loss before income taxes

 

 

(27,471

)

 

 

-346

%

 

 

(26,243

)

 

 

-390

%

 

 

(1,228

)

 

 

5

%

 

 

(28,286

)

 

 

-323

%

 

 

(27,471

)

 

 

-346

%

 

 

(815

)

 

 

3

%

Provision for income taxes

 

 

(14

)

 

 

 

 

 

(11

)

 

 

 

 

 

(3

)

 

 

 

 

 

(1,471

)

 

 

 

 

 

(14

)

 

 

 

 

 

(1,457

)

 

 

21

%

Net loss

 

$

(27,485

)

 

 

-346

%

 

$

(26,254

)

 

 

-391

%

 

$

(1,231

)

 

 

5

%

 

$

(29,757

)

 

 

-340

%

 

$

(27,485

)

 

 

-346

%

 

$

(2,272

)

 

 

8

%

- 31 -


 

Revenue

Total revenue and productfor the quarter ended December 31, 2020 increased by 10% to $8.8 million, compared with $7.9 million for the quarter ended December 31, 2019. Product sales for the quarter ended December 31, 20192020 increased by 18%14% to $7.9$8.7 million, compared with $6.7$7.6 million for the quarter ended December 31, 2018. The increase in total revenue was due to $0.3 million of other revenues arising from the achievement of product development milestones in the quarter ended December 31, 2019 and an increase of 14% in product sales.2019.  The increase in product sales was primarily attributable to growth in product sales to OEM customers, and incremental direct sales of conventional reagent products to customers in the United States. States and sales of the MosaiQ COVID-19 Microarray. Other revenues for the quarter ended December 31, 2020 related to a small development project for an OEM customer. Other revenues in the quarter ended December 31, 2019 arose from the achievement of product development milestones on a development contract, which was completed during the year ended March 31, 2020.    

Products sold by standing purchase order were 72%70% of product sales for the quarter ended December 31, 2019,2020, compared with 67%72% for the quarter ended December 31, 2018.2019.

The table below sets forth revenue by product group:

 

 

Quarter ended December 31,

 

 

 

 

 

 

 

 

 

 

Quarter ended December 31,

 

 

 

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

 

 

2020

 

 

2019

 

 

Change

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

(in thousands, except percentages)

 

 

(in thousands, except percentages)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales - OEM customers

 

$

5,071

 

 

 

64

%

 

$

4,719

 

 

 

70

%

 

$

352

 

 

 

7

%

 

$

5,536

 

 

 

63

%

 

$

5,071

 

 

 

64

%

 

$

465

 

 

 

9

%

Product sales - direct customers and

distributors

 

$

2,565

 

 

 

32

%

 

 

2,004

 

 

 

30

%

 

 

561

 

 

 

28

%

 

$

2,846

 

 

 

33

%

 

 

2,565

 

 

 

32

%

 

 

281

 

 

 

11

%

Product sales - MosaiQ

 

 

358

 

 

 

4

%

 

 

 

 

 

0

%

 

 

358

 

 

 

100

%

Other revenues

 

 

305

 

 

 

4

%

 

 

 

 

 

0

%

 

 

305

 

 

 

 

 

 

11

 

 

 

0

%

 

 

305

 

 

 

4

%

 

 

(294

)

 

 

-96

%

Total revenue

 

$

7,941

 

 

 

100

%

 

$

6,723

 

 

 

100

%

 

$

1,218

 

 

 

18

%

 

$

8,751

 

 

 

100

%

 

$

7,941

 

 

 

100

%

 

$

810

 

 

 

10

%

 

OEM Sales. Product sales to OEM customers increased 7%9% to $5.5 million for the quarter ended December 31, 2020, compared with $5.1 million for the quarter ended December 31, 2019, compared with $4.7 million for the quarter ended December 31, 2018.2019. The increase was due to increased sales to existing customers and the impact of recently launched new products.pricing increases.

- 30 -


Direct Sales to Customers and Distributors. Product sales directly to customers and distributors of $2.8 million for the quarter ended December 31, 2020 increased by $0.3 million compared with $2.6 million for the quarter ended December 31, 2019 increased by $0.6 million compared with $2.0 million for the quarter ended December 31, 2018.2019. This increase was due to increased direct sales in the United States which increased by $0.4to $2.6 million in the quarter ended December 31, 2020 from $2.3 million in the quarter ended December 31, 2019 from $1.9 millionas a result of growth in sales to existing customers and expansion of our customer base.

MosaiQ Product Sales. MosaiQ sales in the quarter ended December 31, 2018 as a result2020 consisted of recent product launches andrevenues from our MosaiQ COVID-19 Microarray. There were no MosaiQ sales in the expansion of our customer base.quarter ended December 31, 2019.

Other Revenues.Revenues. Other revenues in the quarter ended December 31, 2020 related to a small development project for an OEM customer. Other revenues in the quarter ended December 31, 2019 consisted of product development fees which arose as a result offrom the achievement of product development milestones underon a development contract, which was completed during the terms of our umbrella supply agreement with Ortho. See Note 2 “Summary of Significant Accounting Policies — Revenue Recognition” to our condensed consolidated financial statements included in this Quarterly Report for additional information. There were no other revenues in the quarteryear ended DecemberMarch 31, 2018.2020.    

Cost of revenue and gross margin

Cost of revenue increased by 8%10% to $5.0 million for the quarter ended December 31, 2020, compared with $4.5 million for the quarter ended December 31, 2019, compared with $4.2 million for the quarter ended December 31, 2018. This2019. The increase in cost of revenue was primarily related toreflected the incremental costs associated with the 14% increase in productgreater sales in the quarter ended December 31, 2019. In addition, in the quarter ended December 31, 2018, we were in the process of moving our conventional reagents manufacturing operations to our new Biocampus facility in Edinburgh, Scotland and we incurred additional expenditure as a result of operating two facilities. We completed the relocation at the start of 2019 and we no longer bear any costs related to our previous facility in Edinburgh.volumes.  

- 32 -


Gross profit on total revenue for the quarter ended December 31, 20192020 was $3.4$3.8 million, an increase of 11% when compared with $2.5$3.4 million for the quarter ended December 31, 2018.2019.  The increase was attributable to $0.3 million of other revenue in the quarter ended December 31, 2019 and the increase in gross margin on product sales described below.

Gross profit on product sales, which excludes other revenues, was $3.8 million for the quarter ended December 31, 2020, an increase of 21% when compared with $3.1 million for the quarter ended December 31, 2019 compared with $2.5 million for the quarter ended December 31, 2018.2019. This increase was due to a more favorable product mix and lower levels of material scrapped, in addition to the gross profit on increased sales to existing customers and the impact of recently launched new products.  In addition, as described above, in the quarter ended December 31, 2018, we were in the process of moving our conventional reagents manufacturing operations to our new Biocampus facility in Edinburgh, Scotland and we incurred additional expenditure as a result of operating two facilities. customers. Gross margin on product sales, which excludes other revenues, was 43% for the quarter ended December 31, 2020 compared with 41% for the quarter ended December 31, 2019 compared with 38% for the quarter ended December 31, 2018.

Sales and marketing expenses

Sales and marketing expenses were $2.3 million for the quarter ended December 31, 2019,2020, compared with $2.2$2.3 million for the quarter ended December 31, 2018. This increase was attributable to greater personnel and other expenses related to the planned commercial launch of MosaiQ.2019. As a percentage of total revenue, sales and marketing expenses were 26% for the quarter ended December 31, 2020 compared to 29% for the quarter ended December 31, 2019 compared to 33% for the quarter ended December 31, 2018.2019.

Research and development expenses

 

 

Quarter ended December 31,

 

 

 

 

 

 

 

 

 

 

Quarter ended December 31,

 

 

 

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

 

 

2020

 

 

2019

 

 

Change

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

(in thousands, except percentages)

 

 

(in thousands, except percentages)

 

Research and development expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MosaiQ research and development

 

$

13,770

 

 

 

173

%

 

$

11,464

 

 

 

171

%

 

$

2,306

 

 

 

20

%

 

$

14,214

 

 

 

162

%

 

$

13,770

 

 

 

173

%

 

$

444

 

 

 

3

%

Other research and development

 

 

473

 

 

 

6

%

 

 

411

 

 

 

6

%

 

 

62

 

 

 

15

%

 

 

397

 

 

 

5

%

 

 

474

 

 

 

6

%

 

 

(77

)

 

 

-16

%

Tax credits

 

 

(84

)

 

 

-1

%

 

 

(87

)

 

 

-1

%

 

 

3

 

 

 

-4

%

 

 

(126

)

 

 

-1

%

 

 

(84

)

 

 

-1

%

 

 

(42

)

 

 

50

%

Total research and development expenses

 

$

14,160

 

 

 

178

%

 

$

11,788

 

 

 

175

%

 

$

2,372

 

 

 

20

%

 

$

14,485

 

 

 

166

%

 

$

14,160

 

 

 

178

%

 

$

325

 

 

 

2

%

Research and development expenses increased by 20%2% to $14.5 million for the quarter ended December 31, 2020, compared with $14.2 million for the quarter ended December 31, 2019, compared with $11.8 million for2019. During the quarter ended December 31, 2018. This increase was attributable to higher MosaiQ instrument2020, we recorded inventory provisions of $2.0 million in respect of certain raw materials and work-in-progress items following evaluation of further development expenditures,data and corresponding changes in manufacturing processes. These expenses were offset by a $0.5 million decrease in depreciation charges as a result of certain leasehold improvements becoming fully depreciated at the costs associated with our recently completed U.S. field trial forstart of the initial SDS microarray and higher material and labor costs associatedcurrent financial year, as well as the impact of extending the useful economic lives of certain operating equipment. Costs incurred with development work onpartners were also $0.8 million lower during the expanded SDS microarray. Terminationquarter ended December 31, 2020. This decrease was due to our incurring certain upfront contract charges and material deliveries during the quarter ended December 31, 2019 and there were no corresponding charges in the quarter ended December 31, 2020. In addition, termination benefit costs of $0.4 million were also included in quarter ended December 31, 2019. There were no termination benefit costs in the quarter ended December 31, 2018.2020.

- 31 -


General and administrative expenses

General and administrative expenses increaseddecreased by 23%6% to $8.7 million for the quarter ended December 31, 2020, compared with $9.3 million for the quarter ended December 31, 2019, compared2019. The decreases reflected lower legal expenses related to our now settled dispute with $7.5 million for the quarter ended December 31, 2018. OurOrtho, offset by higher D&O insurance and other advisory costs. In addition, our general and administrative expenses included termination and transition benefit costs of $0.9 million in the quarter ended December 31, 2019. We also incurred additional legal and advisory expenses in the quarter ended December 31, 2019 compared to the quarter ended December 31, 2018 related to our dispute with Ortho and the termination of the Ortho Agreement, as well as other incremental costs associated with operating as a public company. In the quarter ended December 31, 2018 we incurred approximately $0.5 million of costs associated with the relocation of our conventional reagents manufacturing operations to our new Biocampus facility, which did not recur in the quarter ended December 31, 2019.We recognized $1.2 million of stock compensation expense in the quarter ended December 31, 20192020 compared with $1.1$1.2 million in the quarter ended December 31, 2018.2019. As a percentage of total revenue, general and administrative expenses were 100% for the quarter ended December 31, 2020 compared to 117% for the quarter ended December 31, 2019 and 112%2019.

- 33 -


Other income (expense)

Net interest expense was $6.8 million for the quarter ended December 31, 2018.

Other income (expense)

Net interest expense was2020, compared with $7.0 million for the quarter ended December 31, 2019, compared with $5.7 million for the quarter ended December 31, 2018.2019. Interest expense in the quarterquarters ended December 31, 2020 and December 31, 2019 included $4.4 million of interest charges on our Secured Notes compared with $3.6 million in the quarter ended December 31, 2018.  The increase was due to the additional issuance of $25 million of Secured Notes on May 15, 2019.Notes. Interest expense in the quarters ended December 31, 20192020 and December 31, 20182019 also included amortization of deferred debt issue costs and estimated royalty costs of $2.7$2.2 million and $1.9$2.6 million, respectively, which included,respectively. The decreased expense reflected changes in the 2019 period, the amortization of the expected costs of the royalty rights agreements entered into in October 2016, June 2018, December 2018 and May 2019 in connection with the issuances of the Secured Notes and the amendment of the indenture relating to the Secured Notes and, in the 2018 period, amortization of the expected costs of the royalty rights agreements entered into in October 2016, June 2018 and December 2018. The additional royalty rights agreements entered into in May 2019 increased in aggregate the amount of royalties payable pursuant to royalty rights agreements from 3% to 3.4% of net sales of MosaiQ instruments and consumables made in the donor testing market in the United States and the European Union.cost estimates. Net interest expense also included $0.3 million of dividends accrued on the 7% cumulative redeemable preference shares in each of the quarters ended December 31, 20192020 and December 31, 2018.2019. In addition, in the quarter ended December 31, 2019,2020 we realized interest income of $0.3$0.1 million on our short-term money market investments.investments compared to $0.3 million for the quarter ended December 31, 2019.

Other, net in the quarter ended December 31, 2019 was2020 comprised of $1.9$0.2 million of foreign exchange gains arising on monetary assets and liabilities denominated in foreign currencies compared to $0.6$1.9 million of foreign exchange lossesgains for the quarter ended December 31, 2018. In the quarter ended December 31, 2018, other expense also included $0.9 million of fees related to the amendment of the indenture related to the Secured Notes in December 2018.2019.

Provision for income taxes

Provision for income taxes in the quarter ended December 31, 2019 reflects2020 reflected the taxes payable on the taxable income of a reduction insubsidiary and the net operating losses availableresolution of a major tax uncertainty related to be carried forwardthe treatment of  tax depreciation allowances, which resulted in a subsidiary as a resultone-time tax charge of the offset of historic tax losses against the profits of this subsidiary.$1.5 million.

- 32 -


 

Comparison of the Nine monthMonth Periods ended December 31, 20192020 and 20182019

The following table sets forth, for the periods indicated, the amounts of certain components of our statements of operations and the percentage of total revenue represented by these items, showing period-to-period changes.

 

 

Nine months ended December 31,

 

 

 

 

 

 

 

 

 

 

Nine months ended December 31,

 

 

 

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

 

 

2020

 

 

2019

 

 

Change

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

(in thousands, except percentages)

 

 

(in thousands, except percentages)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales

 

$

22,901

 

 

 

96

%

 

$

20,834

 

 

 

100

%

 

$

2,067

 

 

 

10

%

 

$

26,207

 

 

 

78

%

 

$

22,901

 

 

 

96

%

 

$

3,306

 

 

 

14

%

Other revenues

 

 

1,055

 

 

 

4

%

 

 

19

 

 

 

0

%

 

 

1,036

 

 

 

5453

%

 

 

7,534

 

 

 

22

%

 

 

1,055

 

 

 

4

%

 

 

6,479

 

 

 

614

%

Total revenue

 

 

23,956

 

 

 

100

%

 

 

20,853

 

 

 

100

%

 

 

3,103

 

 

 

15

%

 

 

33,741

 

 

 

100

%

 

 

23,956

 

 

 

100

%

 

 

9,785

 

 

 

41

%

Cost of revenue

 

 

13,067

 

 

 

55

%

 

 

12,803

 

 

 

61

%

 

 

264

 

 

 

2

%

 

 

14,883

 

 

 

44

%

 

 

13,067

 

 

 

55

%

 

 

1,816

 

 

 

14

%

Gross profit

 

 

10,889

 

 

 

45

%

 

 

8,050

 

 

 

39

%

 

 

2,839

 

 

 

35

%

 

 

18,858

 

 

 

56

%

 

 

10,889

 

 

 

45

%

 

 

7,969

 

 

 

73

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

7,123

 

 

 

30

%

 

 

6,359

 

 

 

30

%

 

 

764

 

 

 

12

%

 

 

6,757

 

 

 

20

%

 

 

7,123

 

 

 

30

%

 

 

(366

)

 

 

-5

%

Research and development

 

 

38,895

 

 

 

162

%

 

 

37,356

 

 

 

179

%

 

 

1,539

 

 

 

4

%

 

 

38,813

 

 

 

115

%

 

 

38,895

 

 

 

162

%

 

 

(82

)

 

 

0

%

General and administrative

 

 

24,092

 

 

 

101

%

 

 

22,964

 

 

 

110

%

 

 

1,128

 

 

 

5

%

 

 

27,832

 

 

 

82

%

 

 

24,092

 

 

 

101

%

 

 

3,740

 

 

 

16

%

Total operating expenses

 

 

70,110

 

 

 

293

%

 

 

66,679

 

 

 

320

%

 

 

3,431

 

 

 

5

%

 

 

73,402

 

 

 

218

%

 

 

70,110

 

 

 

293

%

 

 

3,292

 

 

 

5

%

Operating (loss)

 

 

(59,221

)

 

 

-247

%

 

 

(58,629

)

 

 

-281

%

 

 

(592

)

 

 

1

%

 

 

(54,544

)

 

 

-162

%

 

 

(59,221

)

 

 

-247

%

 

 

4,677

 

 

 

-8

%

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(20,384

)

 

 

-85

%

 

 

(14,614

)

 

 

-70

%

 

 

(5,770

)

 

 

39

%

 

 

(19,537

)

 

 

-58

%

 

 

(20,384

)

 

 

-85

%

 

 

847

 

 

 

-4

%

Other, net

 

 

1,600

 

 

 

7

%

 

 

(5,516

)

 

 

-26

%

 

 

7,116

 

 

 

-129

%

 

 

5,423

 

 

 

16

%

 

 

1,600

 

 

 

7

%

 

 

3,823

 

 

 

239

%

Total other expense, net

 

 

(18,784

)

 

 

-78

%

 

 

(20,130

)

 

 

-97

%

 

 

1,346

 

 

 

-7

%

 

 

(14,114

)

 

 

-42

%

 

 

(18,784

)

 

 

-78

%

 

 

4,670

 

 

 

-25

%

Loss before income taxes

 

 

(78,005

)

 

 

-326

%

 

 

(78,759

)

 

 

-378

%

 

 

754

 

 

 

-1

%

 

 

(68,658

)

 

 

-203

%

 

 

(78,005

)

 

 

-326

%

 

 

9,347

 

 

 

-12

%

Provision for income taxes

 

 

(41

)

 

 

0

%

 

 

(33

)

 

 

 

 

 

(8

)

 

 

100

%

 

 

(1,503

)

 

 

-4

%

 

 

(41

)

 

 

 

 

 

(1,462

)

 

 

3566

%

Net loss

 

$

(78,046

)

 

 

-326

%

 

$

(78,792

)

 

 

-378

%

 

$

746

 

 

 

-1

%

 

$

(70,161

)

 

 

-208

%

 

$

(78,046

)

 

 

-326

%

 

$

7,885

 

 

 

-10

%

- 34 -


 

Revenue

Total revenue and product sales for the nine month period ended December 31, 20192020 increased by 15%41% to 24.0$33.7 million, compared with $20.9$24.0 million for the nine month period ended December 31, 2018.2019. The increase in total revenue was due to $1.1$7.5 million of other revenues arising from the achievement of product development milestones in the nine month period ended December 31, 20192020 and an increase of 10%14% in product sales. Products sold by standing purchase order were 71%69% of product sales for the nine month period ended December 31, 2019,2020, compared with 67%71% for the nine month period ended December 31, 2018.2019.

The table below sets forth revenue by product group:

 

 

Nine months ended December 31,

 

 

 

 

 

 

 

 

 

 

Nine months ended December 31,

 

 

 

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

 

 

2020

 

 

2019

 

 

Change

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

(in thousands, except percentages)

 

 

(in thousands, except percentages)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product sales - OEM customers

 

$

15,354

 

 

 

64

%

 

$

14,744

 

 

 

71

%

 

$

610

 

 

 

4

%

 

$

16,754

 

 

 

50

%

 

$

15,354

 

 

 

64

%

 

$

1,400

 

 

 

9

%

Product sales - direct customers

and distributors

 

 

7,547

 

 

 

32

%

 

 

6,090

 

 

 

29

%

 

 

1,457

 

 

 

24

%

 

 

8,417

 

 

 

25

%

 

 

7,547

 

 

 

32

%

 

 

870

 

 

 

12

%

Product sales - MosaiQ

 

 

1,036

 

 

 

3

%

 

 

 

 

 

0

%

 

 

1,036

 

 

 

100

%

Other revenues

 

 

1,055

 

 

 

4

%

 

 

19

 

 

 

0

%

 

 

1,036

 

 

 

5453

%

 

 

7,534

 

 

 

22

%

 

 

1,055

 

 

 

4

%

 

 

6,479

 

 

 

614

%

Total revenue

 

$

23,956

 

 

 

100

%

 

$

20,853

 

 

 

100

%

 

$

3,103

 

 

 

15

%

 

$

33,741

 

 

 

100

%

 

$

23,956

 

 

 

100

%

 

$

9,785

 

 

 

41

%

 

OEM Sales. Product sales to OEM customers increased 4%9% to $16.8 million for the nine month period ended December 31, 2020, compared with $15.4 million for the nine month period ended December 31, 2019, compared with $14.7 million for the nine month period ended December 31, 2018.2019. The increase was due to increased sales to existing customers and the impact of recently launched new products.

 

- 33 -


Direct Sales to Customers and Distributors. Product sales directly to customers and distributors of $8.4 million for the nine month period ended December 31, 2020 increased by $0.9 million compared with $7.5 million for the nine month period ended December 31, 2019 increased by $1.4 million compared with $6.1 million for the nine month period ended December 31, 2018.2019. This increase was due to increased direct sales in the United States which increased to $7.6 million in the nine month period ended December 31, 2020 from $6.7 million in the nine month period ended December 31, 2019 from $5.5 millionas a result of higher sales to existing customers and the expansion of our customer base.

MosaiQ Product Sales. MosaiQ sales in the nine month period ended December 31, 2018 as a result2020 consisted of recent product launches andrevenues from our MosaiQ COVID-19 Microarray. There were no MosaiQ sales in the expansion of our customer base.

nine month period ended December 31, 2019.  

Other Revenues.Revenues. Other revenues for the nine month period ended December 31, 2020 arose from the recognition of an initial milestone payment of $7.5 million received from Ortho in respect of the development of the MosaiQ IH3 Microarray and a small development project for an OEM customer. Other revenues in the nine month period ended December 31, 2019 consisted of product development fees, which arose as a result offrom the achievement of product development milestones under the terms of our umbrella supply agreement with Ortho. See Note 2 “Summary of Significant Accounting Policies — Revenue Recognition” to our condensed consolidated financial statements included in this Quarterly Report for additional information. Other revenues in the nine month period ended December 31, 2018 consisted of sales of ancillary products related to the MosaiQ instruments,on another development contract, which we sold to a development partner inwas completed during the year ended March 31, 2018, and sales of licenses to use our conventional reagents products.2020.    

 

Cost of revenue and gross margin

 

Cost of revenue increased by 2%14% to $14.9 million for the nine month period ended December 31, 2020, compared with $13.1 million for the nine month period ended December 31, 2019, compared with $12.8 million for the nine month period ended December 31, 2018. This2019. The increase in the cost of revenue was primarily related toreflected additional costs associated with operating social distancing restrictions and the incremental costs associated with the 10%14% increase in product sales in the nine month period ended December 31, 2019. In addition, in the nine month period ended December 31, 2018, we were in the process of moving our conventional reagents manufacturing operations to our new Biocampus facility in Edinburgh, Scotland and we incurred additional expenditure as a result of operating two facilities. We completed the relocation at the start of 2019 and we no longer bear any costs related to our previous facility in Edinburgh.2020.

 

Gross profit on total revenue for the nine month period ended December 31, 20192020 was $10.9$18.9 million, compared with $8.1$10.9 million for the nine month period ended December 31, 2018.2019.  The increase was attributable to $1.1the $6.5 million ofincrease in other revenues in the nine month period ended December 31, 20192020 and the increase in gross margin on product sales described below.

 

Gross profit on product sales, which excludes other revenues, was $11.3 million for the nine month period ended December 31, 2020 compared with $9.8 million for the nine month period ended December 31, 2019 compared with $8.0 million for the nine month period ended December 31, 2018.2019. This increase was due to the gross profit on increased sales to existing and new customers, and the impact of recently launched new products.  In addition, as described above,offset in the nine month period ended December 31, 2018, we were in the process of moving our conventional reagents manufacturing operations to our new Biocampus facility in Edinburgh, Scotland and we incurred additional expenditure as a result of operating two facilities. part by higher costs associated with social distancing requirements. Gross margin on product sales, which excludes other revenues, was 43% for the nine month period ended December 31, 20192020 compared with 39%43% for the nine month period ended December 31, 20182019.

- 35 -


Sales and marketing expenses

Sales and marketing expenses were $6.8 million for the nine month period ended December 31, 2020, compared with $7.1 million for the nine month period ended December 31, 2019, compared with $6.4 million for the nine month period ended December 31, 2018.2019. This increasedecrease was attributable to greater personnelreduced travel expenses and other expenses relatedthe cancellation of sales conferences due to the planned commercial launch of MosaiQ.COVID-19 pandemic. As a percentage of total revenue, sales and marketing expenses were 30% for both the nine month period ended December 31, 2019 and20% for the nine month period ended December 31, 2018.2020 compared to 30% for the nine month period ended December 31, 2019.

Research and development expenses

 

 

Nine months ended December 31,

 

 

 

 

 

 

 

 

 

 

Nine months ended December 31,

 

 

 

 

 

 

 

 

 

 

2019

 

 

2018

 

 

Change

 

 

2020

 

 

2019

 

 

Change

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

% of revenue

 

 

Amount

 

 

%

 

 

(in thousands, except percentages)

 

 

(in thousands, except percentages)

 

Research and development expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MosaiQ research and development

 

$

37,536

 

 

 

157

%

 

$

36,406

 

 

 

175

%

 

$

1,130

 

 

 

3

%

 

$

37,953

 

 

 

112

%

 

$

37,536

 

 

 

157

%

 

$

417

 

 

 

1

%

Other research and development

 

 

1,609

 

 

 

7

%

 

 

1,158

 

 

 

6

%

 

 

451

 

 

 

39

%

 

 

1,409

 

 

 

4

%

 

 

1,609

 

 

 

7

%

 

 

(200

)

 

 

-12

%

Tax credits

 

 

(250

)

 

 

-1

%

 

 

(208

)

 

 

-1

%

 

 

(42

)

 

 

20

%

 

 

(549

)

 

 

-2

%

 

 

(250

)

 

 

-1

%

 

 

(299

)

 

 

120

%

Total research and development

expenses

 

$

38,895

 

 

 

162

%

 

$

37,356

 

 

 

179

%

 

$

1,539

 

 

 

4

%

 

$

38,813

 

 

 

115

%

 

$

38,895

 

 

 

162

%

 

$

(82

)

 

 

0

%

Research and development expenses increaseddecreased by 3%$0.1 million to $38.8 million for the nine month period ended December 31, 2020, compared with $38.9 million for the nine month period ended December 31, 2019, compared with $37.4 million for the nine month period ended December 31, 2018.2019.  Our research and development expenses included an expenseexpenses of $1.0 million in both the nine month periodperiods ended December 31, 20192020 and an expense of $0.5 million in the nine month period ended December 31, 20182019 related to the costs of our intellectual property license with TTP for MosaiQ.

- 34 -


Additional researchTTP. During the nine month period ended December 31, 2020, we recorded inventory provisions of $2.0 million in respect of certain raw materials and work-in-progress items following evaluation of further development expenses related to our recently completed U.S. field trialdata and corresponding changes in manufacturing processes. We also incurred additional development costs for the initial SDS microarray. TerminationMosaiQ COVID-19 Microarray and higher employee costs in the nine month period ended December 31, 2020. These expenses were offset by a $2.6 million decrease in depreciation charges as a result of certain leasehold improvements becoming fully depreciated in the nine month period ended December 31, 2020, as well as the impact of extending the useful economic lives of certain operating equipment. In addition, termination benefit costs of $0.4 million were also included in the nine month period ended December 31, 2019. There were no termination benefit costs in the nine month period ended December 31, 2018.2020.

General and administrative expenses

General and administrative expenses increased by 5%16% to $27.8 million for the nine month period ended December 31, 2020, compared with $24.1 million for the nine month period ended December 31, 2019, comparedreflecting additional legal expenses related to our dispute with $23.0 million for the nine month period ended December 31, 2018. OurOrtho, higher advisory fees and higher D&O insurance costs. In addition, our general and administrative expenses included termination and transition benefit costs of $0.9 million in the nine month period ended December 31, 2019. We also incurred additional legal and advisory expenses in the nine month period ended December 31, 2019 compared to the nine month period ended December 31, 2018 related to our dispute with Ortho and the termination of the Ortho Agreement, as well as incremental costs associated with operating as a public company. In the nine month period ended December 31, 2018 we incurred approximately $1.3 million of costs associated with the relocation of our conventional reagents manufacturing operations to our new Biocampus facility, which did not recur in the nine month periodquarter ended December 31, 2019. We recognized $3.4$3.5 million of stock compensation expense in the nine month period ended December 31, 20192020 compared with $3.6$3.4 million in the nine month period ended December 31, 2018.2019. As a percentage of total revenue, general and administrative expenses were 82% for the nine month period ended December 31, 2020 and 101% for the nine month period ended December 31, 2019 and 110%2019.

Other income (expense)

Net interest expense was $19.5 million for the nine month period ended December 31, 2018.

Other income (expense)

Net interest expense was2020, compared with $20.4 million for the nine month period ended December 31, 2019, compared with $14.6 million for the nine month period ended December 31, 2018.2019. Interest expense in the nine month period ended December 31, 20192020 included $12.8$13.1 million of interest charges on our Secured Notes compared with $9.7$12.8 million in the nine month period ended December 31, 2018.  The increase was due to the additional issuances of $36 million of Secured Notes on June 29, 2018 and $25 million of Secured Notes on May 15, 2019. Interest expense in the nine month periods ended December 31, 20192020 and December 31, 20182019 also included amortization of deferred debt issue costs and estimated royalty costs of $6.6 million and $7.7 million, and $4.1 million, respectively, which included,respectively. The decreased expense reflected changes in the 2019 period, the amortization of the expected costs of the royalty rights agreements entered into in October 2016, June 2018, December 2018 and May 2019 in connection with the issuances of the Secured Notes and the amendment of the indenture relating to the Secured Notes and, in the 2018 period, amortization of the expected costs of the royalty rights agreements entered into in October 2016, June 2018 and December 2018. The additional royalty rights agreements entered into in May 2019 increased in aggregate the amount of royalties payable pursuant to royalty rights agreements from 3% to 3.4% of net sales of MosaiQ instruments and consumables made in the donor testing market in the United States and the European Union.cost estimates. Net interest expense also included $0.8 million of dividends accrued on the 7% cumulative redeemable preference shares in each of the nine month periods ended December 31, 20192020 and December 31, 2018.2019. In addition, in the nine month period ended December 31, 2019,2020 we realized interest income of $0.9$1.0 million on our short-term money market investments.investments compared with $0.9 million for the nine month period ended December 31, 2019.

Other, net in the nine month period ended December 31, 20192020 was comprised of $1.6$5.4 million of foreign exchange gains arising on monetary assets and liabilities denominated in foreign currencies compared to $4.6$1.6 million of foreign exchange lossesgains for the nine month period ended December 31, 2018. In the nine month period ended December 31, 2018, other expense also included $0.9 million of fees related to the amendment of the indenture related to the Secured Notes in December 2018.2019.

- 36 -


Provision for income taxes

Provision for income taxes in the nine month period ended December 31, 2019 reflects2020 reflected the taxes payable on the taxable income of a reduction insubsidiary and the net operating losses availableresolution of a major tax uncertainty related to be carried forwardthe treatment of tax depreciation allowances, which resulted in a subsidiary as a resultone-time tax charge of the offset of historic tax losses against the profits of this subsidiary.$1.5 million.

 

Quarterly Results of Operations

Our quarterly product sales can fluctuate depending upon the shipment cycles for our red blood cell based products, which account for approximately two-thirds of our current product sales. For these products, we typically experience 13 shipping cycles per year. This equates to three shipments of each product per quarter, except for one quarter per year when four shipments occur. In fiscal 2019,2020, the greatest impact of extra product shipments occurred in our first quarter and the greatest impact thus far in fiscal 20202021 has also occurred in the first quarter. The timing of shipment of bulk antisera products to our OEM customers may also impact revenues from quarter to quarter. We also experience some seasonality in demand around holiday periods in both Europe and the United States. As a result of these factors, we expect to continue to see seasonality and quarter-to-quarter variations in our product sales. The timing of product development fees included in other revenues is mostly dependent upon the achievement of pre-negotiated project or revenue milestones.

- 35 -


Liquidity and Capital Resources

Since our commencement of operations in 2007, we have incurred net losses and negative cash flows from operations. As of December 31, 2019,2020, we had an accumulated deficit of $458.7$553.6 million. During the nine month period ended December 31, 2019,2020, we incurred a net loss of $78.0$70.2 million and used $64.8$56.7 million of cash in operating activities. As described under results of operations, our use of cash during the nine month period ended December 31, 20192020 was primarily attributable to our investment in the development of MosaiQ and corporate costs, including costs related to being a public company.

From our incorporation in 2012 to March 31, 2019,2020, we have raised $160.0 million of gross proceeds through the private placement of our ordinary and preference shares and warrants, $250.1$346.7 million of gross proceeds from public offerings of our shares and issuances of ordinary shares upon exercise of warrants and $120.0$145.0 million of gross proceeds from the issuance of the Secured Notes.

On MaySeptember 15, 2019, we issued an additional $25.0 million aggregate principal amount of the Secured Notes. On May 15, 2019, we paid $1.5 million of the net proceeds of the issuance into the cash reserve account maintained with the collateral agent under the terms of the indenture governing the Secured Notes, which together with the $7.2 million paid into the cash reserve account in respect of previous issuances, brought the total in the cash reserve account to $8.7 million at December 31, 2019.

On November 12, 2019,2020, we completed a public offering of 13,800,00020,294,117 newly issued ordinary shares at a price of $7.00$4.25 per share, which raised $96.6$86.3 million of gross proceeds before underwriting discounts and other offering expenses.expenses of $5.6 million.

As of December 31, 2019,2020, we had available cash, cash equivalents and short-term investments of $138.0$134.5 million and $9.0 million of restricted cash held as part of the arrangements relating to our Secured Notes and the lease of our property in Eysins, Switzerland.

Cash Flows for the Nine monthMonth Periods ended December 31, 20192020 and 20182019

Operating activities

Net cash used in operating activities was $56.7 million during the nine month period ended December 31, 2020, which included net losses of $70.2 million offset by non-cash items of $20.2 million. Non-cash items were depreciation and amortization expense of $6.5 million, share-based compensation expense of $3.5 million, Swiss pension costs of $0.8 million, amortization of deferred debt issue costs of $6.6 million, accrued preference share dividends of $0.8 million, deferred lease rentals of $0.5 million and deferred income taxes of $1.5 million. We also experienced a net cash outflow of $6.7 million from changes in operating assets and liabilities during the period, consisting of a $2.8 million reduction in accrued compensation and benefits, a $1.2 million increase in inventories and a $0.3 million increase in other assets and a $3.7 million reduction in accounts payable and accrued liabilities, offset by a $1.3 million reduction in accounts receivables.

Net cash used in operating activities was $64.8 million during the nine month period ended December 31, 2019, which included net losses of $78.0 million offset by non-cash items of $21.7 million. Non-cash items were depreciation and amortization expense of $9.0 million, share-based compensation expense of $3.4 million, Swiss pension costs of $0.6 million, amortization of deferred debt issue costs of $7.7 million, and accrued preference share dividends of $0.8 million and deferred lease rentals of $0.2 million. We also experienced a net cash outflow of $8.5 million from changes in operating assets and liabilities during the period, consisting of a $2.3 million reduction in accounts payable and accrued liabilities, a $0.3 million reduction in accrued compensation and benefits, a $1.6 million increase in accounts receivable, a $3.9 million increase in inventories and a $0.4 million increase in other assets.

- 37 -


Investing activities

Net cash used in operatinginvesting activities was $61.5$18.2 million duringfor the nine month period ended December 31, 2018, which included net losses of $78.8 million offset by non-cash items of $18.7 million. Non-cash items were depreciation and amortization expense of $9.5 million, share-based compensation expense of $3.6 million, Swiss pension costs of $0.5 million, amortization of deferred debt issue costs of $4.1 million, accrued preference share dividends of $0.8 million and an increase in the deferred lease rental benefit of $0.3 million. We also experienced a net cash outflow of $1.4 million from changes in operating assets and liabilities during the period, consisting of a $5.1 million reduction in accounts payable and accrued liabilities and a $0.7 million reduction in accrued compensation and benefits, offset by a $0.3 million decrease in accounts receivable, a $0.1 million decrease in inventories and a $3.8 million decrease in other assets.

- 36 -


Investing activities

Net cash used in investing activities was2020 compared to $46.2 million for the nine month period ended December 31, 2019 compared to $100.2 million for the nine month period ended December 31, 2018.2019. We spent $3.9$3.6 million on purchases of property and equipment in the nine month period ended December 31, 2020, which was mainly related to purchasing MosaiQ instruments and investments in our IT infrastructure. Purchases of property and equipment in the nine month period ended December 31, 2019 were $3.9 million, which was mainly related to payments for an additional assembly unit for our MosaiQ manufacturing facility. Purchases of property and equipment in the nine month ended December 31, 2018 were $3.0 million, which was mainly related to the payment of final costs related to the construction of our new Biocampus conventional reagents manufacturing facility. We also increased our short-term money market investments by $42.3$14.6 million net in the nine month period ended December 31, 20192020, compared with ana net increase of $97.1$42.3 million net infor the nine month period ended December 31, 2018.2019.

Financing activities

Net cash provided by financing activities was $80.4 million during the nine month period ended December 31, 2020, consisting of $80.7 million generated from the issuance of ordinary shares on September 15, 2020 and $0.2 million generated from the exercise of share options, offset by $0.5 million of repayments on finance leases. Net cash provided by financing activities was $114.5 million during the nine month ended December 31, 2019, consisting of $24.1 million of net proceeds from the issuance of additional Secured Notes on May 15, 2019, $90.4 million of net proceeds from the issuance of ordinary shares on November 12, 2019 and $0.3 million from the exercise of share options, offset by $0.3 million of repayments on finance leases. Net cash provided by financing activities was $144.3 million during the nine month period ended December 31, 2018, consisting of $34.8 million of net proceeds from the issuance of additional Secured Notes on June 29, 2018, payment of $3.9 million of consent fees in December 2018 related to the amendment of the indenture relating to the Secured Notes in December 2018 and $113.7 million of proceeds from the issuance of ordinary shares (including $49.2 million in connection with the exercise of warrants and share options), offset by $0.4 million of repayments on finance leases.

 

Operating and Capital Expenditure Requirements

We have not achieved profitability on an annual basis since we commenced operations in 2007 and we expect to incur net losses for at least the next fiscal year. As we move towards the commercial launch of MosaiQ in the donor testing market, we expect our operating expenses during the year ended March 31, 20202021 to be similar to those of the year ended March 31, 2019,2020, as we continue to invest in growing our customer base, expanding our marketing and distribution channels, completing field trials and regulatory filings, hiring additional employees and investing in other product development opportunities while our development expenditures on MosaiQ decrease.

As of December 31, 2019,2020, we had $134.5 million of available cash, cash equivalents and short-term investments of $138.0 million and $9.0 million of restricted cash held as part of the arrangements relating to our Secured Notes and the lease of our property in Eysins, Switzerland.

Our future capital requirements will depend on many factors, including:

our progress in developing and commercializing MosaiQ and the cost required to complete development, obtain regulatory approvals and complete our manufacturing scale up;

our progress in developing and commercializing MosaiQ and the cost required to complete development, obtain regulatory approvals and complete our manufacturing scale up;

our ability to pursue successful alternatives for commercializing MosaiQ in the patient market;

Ortho’s progress in commercializing the MosaiQ IH3 Microarray for the patient testing market;

our ability to manufacture and sell our conventional reagent products, including the costs and timing of further expansion of our sales and marketing efforts;

our ability to manufacture and sell our conventional reagent products, including the costs and timing of further expansion of our sales and marketing efforts;

our ability to collect our accounts receivable;

the impact of the COVID-19 pandemic on the global economy, our business and our development timeline for MosaiQ;

our ability to generate cash from operations;

our ability to collect our accounts receivable;

any acquisition of businesses or technologies that we may undertake; and

our ability to generate cash from operations;

any acquisition of businesses or technologies that we may undertake; and

our ability to penetrate our existing market and new markets.

our ability to penetrate our existing market and new markets.

We expect to fund our operations, including the ongoing development of MosaiQ through successful field trial completion, achievement of required regulatory authorizations and commercialization from the use of existing available cash and short-term investment balances and the issuance of new equity or debt. Our existing available cash and short-term investment balances are adequate to meet our forecasted cash requirements for the next twelve monthsdebt, and accordingly we have prepared theour financial statements on the going concern basis.basis. We may also seek to repay, restructure or refinance our existing indebtedness, including with the proceeds from sales of additional equity or debt securities.

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Contractual Obligations

Our contractual obligations and commitments were summarized in our Annual Report on Form 10-K for the year ended March 31, 2019.2020.

On May 15, 2019, we issued an additional $25 million aggregate principal amount of the Secured Notes and entered into additional royalty rights agreements with the purchasers of the Secured Notes. As a result of these transactions, the aggregate amounts payable under the Secured Notes is $145.0 million, with zero due in less than a year, $66.5 million due in 1-3 years and $78.5 million due in 3-5 years. Interest payments due on the Secured Notes total $57.3 million with $17.4 million due in less than a year, $30.1 million due in 1-3 years and $9.8 million due in 3-5 years. The aggregate estimated amount payable in connection with the royalty rights agreements is $103.2 million, with zero due in less than a year, $4.5 million due in 1-3 years, $20.5 million due in 3-5 years and $78.2 million due in more than 5 years.- 38 -


We note that the capital leases referred to in the summary of our contractual obligations in our Annual Report on Form 10-K are now accounted for as finance leases under current GAAP; however, the nature of these obligations has not changed. There were no other major changes in the nature of our contractual obligations and commitments between March 31, 2019 and December 31, 2019.

Critical Accounting Policies and Significant Judgments and Estimates

We have prepared our condensed consolidated financial statements in accordance with U.S. GAAP. Our preparation of these condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures at the date of the consolidated financial statements, as well as revenue and expenses during the reporting periods. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in Note 2 to our condensed consolidated financial statements included in this Quarterly Report, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our financial statements.

Revenue recognition and accounts receivable

Revenue is recognized in accordance with Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers. Product revenue is recognized at a point in time upon transfer of control of a product to a customer, which is generally at the time of deliveryshipment at an amount based on the transaction price. Customers have no right of return except in the case of damaged goods and we have not experienced any significant returns of our products.

We also earn revenue from the provision of development services to a small number of OEM customers. These development service contracts are reviewed individually to determine the nature of the performance obligations and the associated transaction prices.  In recent years, our product development revenues have been commensurate with achieving milestones specified in the respective development agreements relating to those products. These milestones may include the approval of new products by the European or U.S. regulatory authorities, which are not within our control. While there can be no assurance that this will continue to be the case, the nature of the milestones has been such that they effectively represent completion of our performance obligations under a particular part of a development program. Should we fail to achieve these milestones, we are not entitled under the terms of the development agreements to any compensation related to the work undertaken to date. As a result, we typically fully recognize milestone-related revenues as the contractual milestones are achieved.

Under certain development contracts, we also manufacture and supply the customer with finished products once they have been approved for use by relevant regulatory agencies. These agreements reflect both arrangements for product development and the sales prices and other contractual terms for subsequent supply of the product to the customer. Under these development contracts, we view the development service revenue as distinct from subsequent product sales revenue, and we recognize each separately as described above.

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Accounts receivable consist primarily of amounts due from OEM customers, hospitals, donor testing laboratories, and distributors. Accounts receivable are reported net of an allowance for uncollectible accounts, which we also refer to as doubtful accounts. The allowance for doubtful accounts represents a reserve for estimated losses resulting from our inability to collect amounts due from our customers. Direct sales, where we may make many low value sales to a large number of customers, represents a larger risk of doubtful accounts, as opposed to OEM customer sales consisting primarily of a small number of well established businesses with whom we have a long trading history. The collectability of our trade receivables balances is regularly evaluated based on a combination of factors such as the ageingaging profile of our receivables, past history with our customers, changes in customer payment patterns, customer credit-worthiness and any other relevant factors. Based on these assessments, we adjust the reserve for doubtful accounts recorded in our financial statements.

Inventories

We record inventories at the lower of cost (first-in, first-out basis)(at standard costs, approximating average costs) or market (net realizable value), net of reserves. We record adjustments to inventory based upon historic usage, expected future demand and shelf life of the products held in inventory. We also calculate our inventory value based on the standard cost of each product. This approach requires us to analyze variances arising in the production process to determine whether they reflect part of the normal cost of production, and should therefore be reflected as inventory value, or whether they are a period cost and should thus not be included in inventory.

Intangible assets

The intangible assets included in our financial statements include intangible assets identified as at the time of the acquisition of the business of Alba Bioscience on August 31, 2007. At the time of this acquisition, we identified intangible assets related to customer relationships, master cell lines and certain other items, which include domain names and product trademarks. The customer relationships have been amortized over a five-year period, which resulted in them becoming fully amortized at August 31, 2012. The other items were amortized over a seven-year period from August 31, 2007, which resulted in them becoming fully amortized at August 31, 2014.

The intangible assets related to master cell lines reflect the know-how and market recognition associated with the cell lines, which are used as the source material of certain of our products. These cell lines are maintained by us and have an indefinite life. We have nevertheless decided to amortize the intangible assets over a forty-year period to reflect the possibility of market changes or other events resulting in the lines becoming technically obsolete at some future date. In the event that any of the lines cease to be used, we would record additional amortization at that point.

We also include in intangible assets the costs of obtaining product licenses for our products. These include external costs such as regulatory agency fees associated with the approval and bringing to market of our products once the development is complete. We amortize these over an expected product life of ten years, although if any such product ceased to be produced, we would record additional amortization at that point.

Income taxes

We account for income taxes under the asset and liability method, which requires, among other things, that deferred income taxes be provided for temporary differences between the tax basis of our assets and liabilities and their financial statement reported amounts. In addition, deferred tax assets are recorded for the future benefit of utilizing NOLs and research and development credit carry forwards. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized.

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We follow the accounting guidance for uncertainties in income taxes, which prescribes a recognition threshold and measurement process for recording uncertain tax positions taken, or expected to be taken, in a tax return in the financial statements. Additionally, the guidance also prescribes the derecognition, classification, accounting in interim periods and disclosure requirements for uncertain tax positions. We accrue for the estimated amount of taxes for uncertain tax positions if it is more likely than not that we would be required to pay such additional taxes. An uncertain tax position will not be recognized if it has less than a 50% likelihood of being sustained.

We did not have any accrued interest or penalties associated with any unrecognized tax positions, and there were no such interest or penalties recognized during the nine month periodquarter ended December 31, 20192020 or in the year ended March 31, 2019.2020.

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Stock compensation expense

Stock compensation expense is measured at the grant date based on the fair value of the award and is recognized as an expense in the income statement over the vesting period of the award. The calculation of the stock compensation expense is sensitive to the fair value of the underlying ordinary shares. The fair value of option awards and multi-year performance based restricted share units or MRSUs at the grant date is calculated using the Black-Scholes model or other valuation models, which use a number of assumptions to determine the fair value. Details of the assumptions used are set out in the notes to the condensed consolidated financial statements included in this Quarterly Report.

Defined Benefit Pension Obligations

We account for the pension obligations of our Swiss subsidiary as a defined benefit plan under Accounting Standards Codification Topic 715 Compensation – Retirement Benefits,or ASC 715.  This requires that an actuarial valuation be performed to determine the funded status of the pension arrangements.  The actuarial valuation is based on a number of assumptions, details of which are set out in the notes to the audited consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2019.2020.

Royalty Liability

The royalty rights agreements entered into in connection with the issuances of our Secured Notes and the amendment of the related indenture are treated as sales of future revenues that meet the requirements of Accounting Standards Codification Topic 470 “Debt” to be treated as debt. The estimated future cash outflows under the royalty rights agreements have been combined with the Secured Notes issuance costs and interest payable to calculate the effective interest rate of the Secured Notes and will be expensed through interest expenses using the effective interest rate method over the term of the Secured Notes and royalty rights agreements. Estimating the future cash outflows under the royalty rights agreements requires us to make certain estimates and assumptions about future sales of MosaiQ products. These estimates of the magnitude and timing of MosaiQ sales are subject to significant variability due to the current status of development of MosaiQ products, and thus are subject to significant uncertainty. Therefore, the estimates are likely to change as we gain experience of marketing MosaiQ, which may result in future adjustments to the accretion of the interest expense and the amortized cost based carrying value of the Secured Notes.

Leases

 

In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update or ASU 2016-02, Leases, or ASU 2016-02, to enhance the transparency and comparability of financial reporting related to leasing arrangements. We adopted ASU 2016-02 on April 1, 2019, or the effective date, and used the effective date as our date of initial application.

At the inception of an arrangement, we determine whether the arrangement is or contains a lease based on the unique facts and circumstances present. A lease is a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment (an identified asset) for a period of time, in exchange for consideration. We determine if the contract conveys the right to control the use of an identified asset for a period of time. We assess throughout the period of use whether we have both of the following: (1) the right to obtain substantially all of the economic benefits for use of the identified asset, and (2) the right to direct the use of the identified asset. This determination is reassessed if the terms of the contract are changed. We also review the terms of the lease in accordance with ASUAccounting Standards Update, or “ASU”, 2016-02, Leases” in order to determine whether the lease concerned is a finance or an operating lease. Most leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. We have elected not to recognize on the balance sheet leases with terms of one year or less.

 

For finance leases, an asset is included within property and equipment and a lease liability equal to the present value of the minimum lease payments is included in current or long-term liabilities. Interest expense is recorded over the life of the lease at a constant rate.

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Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. The operating lease right-of-use assets also include any lease payments made prior to the commencement date and any initial direct costs incurred, less any lease incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, we utilize our incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The incremental borrowing rate is determined at lease commencement, or as of April 1, 2019 for operating leases existing upon the adoption of ASU 2016-02. The incremental borrowing rate is subsequently reassessed upon modification to the lease arrangement. Operating lease expense is recognized on a straight-line basis over the lease term.

 

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In accordance with the guidance in ASU 2016-02, components of a lease should be split into three categories: lease components (e.g., land, building, etc.), non-lease components (e.g., common area maintenance, maintenance, consumables, etc.), and non-components (e.g., property taxes, insurance, etc.). Although separation of lease and non-lease components is required, certain practical expedients are available. In particular, entities may elect a practical expedient to not separate lease and non-lease components and instead account for each lease component and the related non-lease component together as a single component. We have elected to account for the lease and non-lease components of each of its operating leases as a single lease component and allocate all of the contract consideration to the lease component only. The lease component results in an operating lease right-of-use asset being recorded on the balance sheet and amortized on a straight-line basis as lease expense.

The finance lease assets and operating lease right-of-use assets are assessed for impairment in accordance with the Company’sour accounting policy for long-lived assets.

Off-Balance Sheet Arrangements

We do not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or for any other contractually narrow or limited purpose.

Recent Accounting Pronouncements

Refer to Note 2 to our accompanying unaudited condensed consolidated financial statements included elsewhere in this reportQuarterly Report for a discussion of recently issued accounting pronouncements.

JOBS Act

Under the Jumpstart Our Business Startups Act of 2012, emerging growth companies that become public can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are exposed to market risks in the ordinary course of our business. These market risks are principally limited to interest rate fluctuations and foreign currency exchange rate fluctuations.

Interest rate sensitivity

We are exposed to market risk related to changes in interest rates as it impacts our interest income and expense.

Cash, cash equivalents and cash reserve account. At December 31, 2019,2020, we had cash and cash equivalents of $138.0$3.4 million and we also held $9.0 million of restricted cash. Our exposure to market risk includes interest income sensitivity, which is impacted by changes in the general level of U.S. and European interest rates. Our cash and cash equivalents and the restricted cash are held in interest-bearing savings accounts and bank accounts. We do not enter into investments for trading or speculative purposes. Due to the current levels of interest rates, we do not believe an immediate one percentage point change in interest rates would have a material effect on the fair market value of our holdings, and therefore we do not expect our operating results or cash flows to be significantly affected by changes in market interest rates.

Senior securedSecured notes. At December 31, 2019,2020, we had term debt of $145 million outstanding under the Secured Notes. The Secured Notes are fixed-rate instruments and, as a result, a change in market interest rates has no impact on our interest expense incurred or cash flows.

Foreign currency exchange risk

The main currencies that we use for our trading operations are the U.S. Dollar, the Pound Sterling, the Swiss Franc and, to a lesser extent, the Euro. Our meaningful cash balances are held in a mixture of U.S. Dollars, Euros, Pounds Sterling and Swiss Francs. These cash balances may not be the same as the functional currencies of the Quotient entities in which they are held and, as a result, exchange rate fluctuations may result in foreign exchange gains and losses on our income statement.

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We are subject to market risks arising from changes in foreign currency exchange rates between the U.S. Dollar and the Pound Sterling and the U.S. Dollar and the Swiss Franc. Accordingly, fluctuations in the U.S. Dollar versus Pounds Sterling and U.S. Dollar versus the Swiss Franc exchange rate give rise to exchange gains and losses. These gains and losses arise from the conversion of U.S. Dollars and Euros to Pounds Sterling and the retranslation of cash, accounts receivable, intercompany indebtedness and other asset and liability balances. Based on our assets and liabilities held in Pounds Sterling at December 31, 2019,2020, we estimate that a 5% strengthening of the Pound Sterling against the U.S. Dollar would give rise to a gain of approximately $0.7$0.8 million and a 5% weakening of the Pound Sterling against the U.S. Dollar would give rise to loss of approximately $0.7$0.8 million. Based on our assets and liabilities held in Swiss Francs at December 31, 2019,2020, we estimate that a 5% strengthening of the Swiss Franc against the U.S. Dollar would give rise to a gain of approximately $1.2$1.4 million and a 5% weakening of the Swiss Franc against the U.S. Dollar would give rise to loss of approximately $1.2$1.4 million.

Most of our revenues are earned in U.S. Dollars, but the costs of our conventional reagent manufacturing operations are payable mainly in Pounds Sterling. We therefore closely monitor the results of our UK operations to address this difference. During the year ended March 31, 2019,2020, the net operating expenses arising in Pounds Sterling from our UK conventional reagent manufacturing operations amounted to $27.0$25.8 million. This expenditure was offset by revenues arising in U.S. Dollars and other currencies. We have entered into forward contracts to hedge against the effects of fluctuations in the U.S. Dollar versus the Pounds Sterling exchange rate. The principal value of the hedges related to the results of fiscal year 20202021 is $6.0 million and, based on this, a hypothetical instantaneous 5% strengthening of the Pound Sterling against the U.S. Dollar would reduce our net income by $1.1$1.0 million in the year ending March 31, 20202021 after taking account of the shelter provided by our existing hedging arrangements through March 31, 2020.2021. Similarly, a hypothetical instantaneous 5% weakening of the Pound Sterling against the U.S. Dollar would increase group net income by $1.1$1.0 million over the same period.

We do not use financial instruments for trading or other speculative purposes.

Our management does not believe that inflation in past years has had a significant impact on our results from operations. In the event inflation affects our costs in the future, we will offset the effect of inflation and maintain appropriate margins through increased selling prices.

 

 

Item 4.4.  Controls and Procedures

Evaluation of disclosure controls and procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Quarterly Report on Form 10-Q. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationshipattributes of possible controls and procedures.

Based on suchtheir evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2019,2020, due to our identification of a material weakness in internal control over financial reporting as described below, our disclosure controls and procedures were not effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our Chief Executive and Chief Financial Officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

A material weakness is defined as “a deficiency, or a combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.”

During the quarter ended September 30, 2020, management identified a material weakness in the design of our internal control over the classification of indebtedness and the consistency of our primary financial statements with the underlying note disclosures. This material weakness also existed at June 30, 2020 and, specifically, resulted in $12,083 thousand of indebtedness being classified as non-current liabilities instead of current liabilities in the condensed consolidated balance sheet as of June 30, 2020, while the correct maturity analysis was presented within the related note disclosure. This error had no impact on the condensed consolidated statement of comprehensive income, condensed consolidated statement of changes in shareholders’ equity, or condensed consolidated statement of cash flows for the quarter ended June 30, 2020, and this error was corrected prior to the issuance of the condensed consolidated financial statements for the quarter ended September 30, 2020.

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Changes in internal control over financial reporting

There were no material changes to our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We did implement internal controlsreporting, other than noted above and except for the following changes:

In order to ensure we properly assessremediate the impact of the new accounting standard related to leases on our financial statements to facilitate its adoption on April 1, 2019. However, there were no material changes to our internal control over financial reporting dueweakness described above, management has implemented immediate steps with regards to the adoptionclassification of long-term debt by:

Automating compilation of relevant captions of the primary financial statements from the detailed underlying accounting records

Strengthening overall disclosure review controls through additional formal review processes

Based on the new accounting standard.  foregoing process and remediation measures, management believes that the above mentioned control deficiency will be remediated, but the material weakness cannot be considered remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.

 

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PARTPART II – OTHER INFORMATION

Item 1. Legal Proceedings

We are not currently aOur subsidiaries, Quotient Suisse and QBD (QS-IP) Limited were party to any pending legal proceedingsa distribution and supply agreement with Ortho related to the commercialization and distribution of certain MosaiQ products, which we refer to as the Prior Ortho Agreement. We also entered into a subscription agreement with an affiliate of Ortho pursuant to which the affiliate subscribed for our newly issued ordinary shares and newly issued 7% cumulative redeemable preference shares, of no par value, for an aggregate subscription price of approximately $25 million.

On November 27, 2019, we delivered a notice to Ortho that we believe couldhad terminated the Prior Ortho Agreement, effective as of December 27, 2019.  We had not realized any revenue under the Prior Ortho Agreement prior to its termination.  

On or about November 17, 2019, Ortho initiated an arbitration proceeding in which it sought a declaration that we did not have the right to terminate the Prior Ortho Agreement, specific performance of certain provisions of the Prior Ortho Agreement, and damages including in respect of the difference in amounts Ortho invested in our shares and their market value.  We pursued counterclaims against Ortho, including that we had the right to terminate the Prior Ortho Agreement and damages that included the milestone payments due under the Prior Ortho Agreement.  In addition, on December 20, 2019, we entered into an agreement, or the Ortho Dispute Agreement, with Ortho pursuant to which we agreed, while the arbitration was pending, not to grant commercialization rights in respect of products that overlapped with Ortho’s rights under the Prior Ortho Agreement without prior written notice to Ortho.  

On September 4, 2020, we entered into a material adverse effectbinding letter agreement with Ortho (or the Letter Agreement) pursuant to which we and Ortho agreed to confirm the termination of the Prior Ortho Agreement and various related contracts and to end the parties’ disputes regarding the Prior Ortho Agreement by executing mutual releases and terminating their pending arbitration proceeding related to the Prior Ortho Agreement.

We also agreed with Ortho to negotiate in good faith, and use our respective reasonable best efforts to execute, a new distribution agreement based on the terms set forth in the Letter Agreement, but if for any reason no such definitive agreement is reached, the Letter Agreement will govern the parties’ respective rights and obligations as a binding contract. See Note 2, "Summary of Significant Accounting Policies—Revenue Recognition" to our business orcondensed consolidated financial condition. However, westatements included in this Quarterly Report for additional information about the Letter Agreement.

We may also be subject to variousother claims and legal actions arising in the ordinary course of business from time to time.

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Item 1A. Risk Factors

Except as set forth below, there have been no material changes in the risk factors described in Item 1A "Risk Factors" of our Annual Report on Form 10-K for the year ended March 31, 20192020.

Our commercialization plan for MosaiQ in the patient transfusion diagnostics market depends on our distributor relationship with Ortho, and Part II, Item 1A “Risk Factors”we may enter into additional distribution or sales arrangements in the future that may subject us to similar risks.

We will rely on Ortho to commercialize MosaiQ in the highly fragmented patient transfusion diagnostics market in Europe and the United States. Under our distributor relationship with Ortho, we will develop sell the MosaiQ IH3 Microarray for the patient transfusion market, and Ortho will have the right to distribute, market and sell the MosaiQ IH3 Microarray in Europe and in the United States, solely for use in testing the immuno-hematological profile of the blood of medical patients in the course of their care or treatment. Ortho may not commit sufficient resources to this commercialization arrangement, as MosaiQ may compete for time, attention and resources with Ortho’s internal programs, or Ortho otherwise may not perform its obligations as expected. In addition, Ortho is both a customer and a competitor of our Quarterly Reportconventional reagent business. If Ortho is unable, or fails, to perform its obligations, there can be no assurance that we will be able to enter into commercialization relationships with other partners with sufficient existing global sales and support infrastructures necessary to successfully commercialize MosaiQ in the patient transfusion diagnostics market in these territories. Any of these risks could delay the commercialization of MosaiQ in the patient transfusion diagnostics market, result in high costs to us or otherwise materially harm our business and adversely affect our future revenues.

We may also enter into additional distribution or sales arrangements to commercialize MosaiQ in other markets. To the extent that we enter into other distribution or sales arrangements, our product revenue is likely to be lower than if we directly market or sell MosaiQ. In addition, any revenue we receive will depend in whole or in part upon the efforts of third parties, which may not be successful and will generally not be within our control. If we are not successful in commercializing MosaiQ through collaborations with one or more third parties, our future product revenue will suffer and we may incur significant additional losses.

We may need to raise additional capital, which may not be available on Form 10-Q forfavorable terms, if at all, and which may cause dilution to shareholders, restrict our operations or adversely affect our ability to operate our business.

We expect to fund our operations in the quarter ended September 30, 2019.

near-term, including the ongoing development of MosaiQ through successful field trial completion, achievement of required regulatory authorizations and commercialization, from a combination of funding sources, including with available cash and short-term investment balances and the issuance of new equity or debt. Our ability to raise additional capital may be significantly affected by general market conditions, the market price of our ordinary shares, our financial condition, uncertainty about the future commercial success of MosaiQ, regulatory developments, the status and scope of our intellectual property, any ongoing arbitration or litigation, our compliance with applicable laws and regulations and other factors, many of which are outside our control.  Furthermore, the indenture governing the Secured Notes contains limitations on our ability to incur debt and issue preferred and/or disqualified stock. Accordingly, we cannot be certain that we will be able to obtain additional financing on favorable terms or at all.  If we are unable to obtain needed financing on acceptable terms, or otherwise, we may not be able to implement our business plan, which could have a material adverse effect on our business, financial condition and results of operations, including a decline in the trading price of our ordinary shares. Any additional equity financings could result in additional dilution to our then existing shareholders. In addition, we may enter into additional financings that restrict our operations or adversely affect our ability to operate our business and, if we issue equity, debt or other securities to raise additional capital or restructure or refinance our existing indebtedness, the new equity, debt or other securities may have rights, preferences and privileges senior to those of our existing shareholders.

Recent global economic and political conditions could result in significant changes to legislation, government policies, rules and regulations, which may have a material adverse effect on our business.

The impact of recent political and economic developments in the United States, the United Kingdom and Europe, including the legislative and trade policy agenda of President Donald Trump and the United Kingdom'sKingdom’s exit from the European Union, commonly referred to as "Brexit,"“Brexit,” are uncertain. These political and economic developments could result in changes to legislation or reformation of government policies, rules and regulations pertaining to the U.S. healthcare system, tax and trade. Such changes could have a significant impact on our business by increasing the cost of doing business, affecting our ability to sell our products and negatively impacting our profitability. In addition, these developments, or continuing uncertainty surrounding these developments, could result in significant financial market volatility, and could also exacerbate, or result in, a slow-down of growth in global, localU.S. and U.S.other economies, which could have a material adverse effect on our operating performance and the market price of our ordinary shares.

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Efforts to repeal and replace the U.S. Patient Protection and Affordable Care Act, or the PPACA, have been ongoing since the 2016 election, but it is unclear if these efforts will be successful.  Since January 2017, President Trump has signed two Executive Orders to delay, circumvent or loosen the implementation of certain requirements mandated by the PPACA or otherwise circumvent some of the requirements for health insurance mandated by the PPACA.  In addition, as part of the December 2017 Tax Cuts and Jobs Act, the "individual mandate," which required individuals to purchase insurance, was repealed.  The PPACA significantly impacts the pharmaceutical and medical device industries and clinical laboratories, and the repeal, replacement or modification of the PPACA, or other legislative or regulatory actions, could meaningfully further change the way healthcare services are delivered and may materially impact aspects of our business.  We cannot predict whether future healthcare initiatives will be implemented at the federal or state level or in countries outside of the United States in which we may do business, or the effect any future legislation or regulation will have on us.

Our conventional reagent products are manufactured in Scotland and our MosaiQ Instruments and Microarrays are manufactured in Germany and Switzerland, respectively.  In the United States, President Trump's administration has discussed, and in some cases implemented, changes with respect to certain tax and trade policies, tariffs and other government regulations affecting trade between the United States and other countries. For example, trade relations between the United States and China were, at times, significantly strained during calendar 2019, as both countries imposed increased tariffs on the importation of certain product categories. While it is not possible to predict whether or when any additional changes will occur or what form they may take, the implementation of a border tax, tariff or higher customs duties on our products imported into the United States, or any potential corresponding actions by other countries in which we do business, could negatively impact our financial performance. In addition, other countries may change their business and trade policies in anticipation of or in response to increased import tariffs and other changes in United States’ trade policy and regulations, which could also negatively impact our financial performance.

Furthermore,particular, on January 31, 2020, the United Kingdom ceased to be a member state of the European Union. As of that date,Union and, on December 31, 2020, the United Kingdom entered a transitional period with the European Union, which is expectedceased to continue through December 31, 2020. During this transitional period, the United Kingdom retains access tobe part of the E.U. single market and customs union, as well as all E.U. policies and international agreements. As a result, the United Kingdomfree movement of persons, goods, services and the European Union are expected to attempt to negotiate various aspects of their future relationship following the transitional period, including a free trade deal. The long-term effects of Brexit will depend on the agreements or arrangementscapital between the United Kingdom and the European Union ended, and the extent to whichEuropean Union and the United Kingdom retainsformed two separate markets and two distinct regulatory and legal spaces. On December 24, 2020, the European Commission reached a trade agreement with the United Kingdom on the terms of its future cooperation with the European Union, which we refer to as the “Trade Agreement”. The Trade Agreement offers U.K. and E.U. companies preferential access to the E.U.each other's markets, both duringensuring imported goods will be free of tariffs and after the transitional period. The longer termquotas; however, economic legal, political and social framework to be put in placerelations between the United Kingdom and the European Union is unclearwill now be on more restricted terms than existed previously. In addition, the Trade Agreement sets out certain procedures for approval and recognition of medical products. 

Although we cannot predict at this stagetime the full impact that Brexit and the Trade Agreement may have on our business, operations and financial results, we do expect that Brexit will impact our regulatory approval plan for MosaiQ. The European Union is transitioning from the existing European Directive 98/79/EC on in vitro diagnostic medical devices, or the IVDD, to the In Vitro Diagnostic Device Regulation, or the IVDR, which will repeal and replace the IVDD. Unlike the IVDD, which must be implemented into the national laws of the Member States of the European Economic Area, or EEA, the IVDR will be directly applicable in all EEA Member States and is likelyintended to leadeliminate current differences in the regulation of in vitro diagnostic medical devices among EEA Member States. However, due to ongoing politicalBrexit, the United Kingdom will not be subject to the IVDR and economic uncertainty and periods of exacerbated volatility in bothhas instead introduced its own regulatory framework. As a result, there is a new conformity marking solely for the United Kingdom and, as of January 1, 2021, any new products require a U.K. Conformity Assessed, or UKCA, mark, in wider European markets for some time.addition to a CE mark. However, our existing products will be able to rely on CE marks previously obtained during a transition period that will last until June 30, 2023.  

We incur increased costs as a result of being a public company whose ordinary shares are publicly traded in the United States and our management must devote substantial time to public company compliance programs.

While we believeAs a public company, we have developed plansincurred and will continue to manage the Brexit-related risksincur significant legal, insurance, accounting and other expenses that we did not incur as a private company. We intend to our businesscontinue to invest resources to comply with evolving laws, regulations and operations, including in the event that the United Kingdomstandards, and the European Union fail to finalize an agreement on the United Kingdom's future relationship with the

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European Union before the end of the transitional period, it is unknown what the final terms of the relationshipthis investment will be.  If no agreement can be reached before the end of the transitional period, there will be a period of considerable uncertainty, particularly in relation to the U.K. financial and banking markets, the regulatory process in Europe and movement of goods and people between the United Kingdom and European Union.  It is also possible that, even if there is an agreement, there will be greater restrictions and transportation delays on imports and exports between the United Kingdom and European Union countries and increased regulatory complexities, which could result in delays and increased expenses relating to the regulatory approval of our products.  In addition, depending on the terms of the agreement, the United Kingdom could lose the benefits of global trade agreements negotiated by the European Union on behalf of its members, which may result in increased trade barriers which could makegeneral and administrative expenses and may divert management’s time and attention. If our doingefforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us and our business worldwide more difficult.  Furthermore, currency exchange ratesmay be harmed. Our insurance costs have increased, particularly for directors’ and officers’ liability insurance. Such costs may further increase in the pound sterlingfuture, and the euro with respectwe may be required to each otheraccept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult for us to attract and the U.S. dollar have already been adversely affected by Brexit.  Should this foreign exchange volatility continue, it could cause volatility inretain qualified members of our financial results.

The outcomeBoard of any current or future disputes, claims, arbitration and litigation could have a material adverse effectDirectors, particularly to serve on our business, financial conditionaudit committee and resultsremuneration committee, and qualified executive officers.

Pursuant to Section 404 of operations.

We are currently involved in an arbitration dispute with Ortho regarding the Ortho Agreement.  See “Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Our Business –Ortho Distribution and Supply Agreement.”  In addition, we may, from time to time, be party to arbitrationSarbanes-Oxley Act, or litigation in the normal course of business, including class action and product liability lawsuits. Due to the inherent uncertainties of litigation and arbitration, it is not possible to predict the final outcome of these arbitrations, lawsuits and proceedings or determine the amount of any potential losses we may incur. In the eventSection 404, we are required or determine to pay amounts in connection with any such arbitrations, lawsuits or other proceedings, such amounts could be significantfurnish a report by our management on our internal control over financial reporting on an annual basis, and could haveour management is also required to evaluate our disclosure controls and procedures quarterly.  During the quarter ended September 30, 2020, we identified a material adverse impact onweakness in our liquidity, business,internal control over financial conditionreporting and resultsconcluded that our disclosure controls were not effective as of operations.  Furthermore, Ortho is a significant customerSeptember 30, 2020 or June 30, 2020. Due to this material weakness, we have also concluded that our disclosure controls were not effective as of our conventional reagent businessDecember 31, 2020. For additional information, see Part I, Item 4 "Controls and accounts for a substantial percentage of our product sales and total revenues.Procedures". We cannot predict the impactassure you that there will not be additional material weaknesses or significant deficiencies in our dispute with Ortho may have on our conventional reagent business.

Our commercialization plan for MosaiQinternal controls in the patient testing market may depend on entering into arrangements with one or more commercial partners.future.

Our initial MosaiQ IH Microarray and our second, expanded MosaiQ IH Microarray are being developed for the donor testing market, with our initial focus being on Europe and the United States, while our third MosaiQ IH Microarray is being developed for the patient testing market. We had previously contracted with Ortho to commercialize the MosaiQ IH Microarray in the patient testing market.  However, as a result of the termination of the Ortho Agreement, we are currently not party to a commercialization arrangement for the MosaiQ IH Microarray in the patient testing market, and, while our dispute with Ortho has been ongoing, we have not pursued alternatives for commercializing our MosaiQ IH Microarray in this market.  

Commercializing MosaiQ in the patient testing market, which is highly fragmented, will require a global sales and support infrastructure.  Our future commercialization plan for this market may include identifying and engaging one or more partners with an existing global commercial infrastructure.  Unless we engage such a partner to assist us, we do not believe we would choose to commercialize MosaiQ ourselves without significant additional funds to build our own global sales and support team. Even if we successfully establish new commercialization arrangements, these relationships may never result in the successful commercialization of MosaiQ in the patient testing market.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

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Item 5. Other Information

None.On January 29, 2021, we announced the following changes to our management team:

Ernest Larnach resigned from his position as our Head of Financial Accounting and Treasury and as our principal accounting officer, effective February 1, 2021.

Vittoria Bonasso, age 44, was appointed as our Head of Finance & Group Controller, effective February 1, 2021, and will take on the position of principal accounting officer following an initial on-boarding period.

We and Ms. Bonasso have entered into an employment agreement in connection with her appointment as our Head of Finance & Group Controller.

Resignation of Ernest Larnach as our Head of Financial Accounting and Treasury and Principal Accounting Officer

On January 29, 2021, Mr. Larnach, our Head of Financial Accounting and Treasury and our principal accounting officer, notified us of his decision to leave our company to pursue other career opportunities. Effective February 1, 2021, he resigned from his position as our Head of Financial Accounting and Treasury and our principal accounting officer. Following his resignation date, he will serve as our Head of Group Accounting and will continue to support us through the close of the financial year ended March 31, 2021 and the preparation of our Annual Report on Form 10-K until the end of May 2021 to ensure a smooth transition.

Appointment of Vittoria Bonasso as our Head of Finance & Group Controller and Principal Accounting Officer

On February 1, 2021, Ms. Bonasso joined our company as our Head of Finance & Group Controller. Ms. Bonasso brings over 20 years of experience in public accounting and strategic and financial leadership of healthcare and technology businesses. From 2017 to 2020, Ms. Bonasso served as the Director of Global Financial Controlling & Deputy Chief Financial Officer at EHL Group, a company focused on hospitality education. From 2015 to 2016, Ms. Bonasso served as the Director of Europe Group Controller at eBay Inc., where, among others, she oversaw controlling, accounting and financial reporting activities. From 2010 to 2015, Ms. Bonasso held various roles at Stryker Corporation, a medical technologies corporation, most recently as Director of Finance for Eastern Europe, Middle East & Africa (EEMEA), Regional Chief Financial Officer and Member of the Board of Directors and Leadership Team. From 1998 to 2010, Ms. Bonasso held various roles at PricewaterhouseCoopers, most recently as a Senior Manager specialized in managing large and complex audits of listed multinational corporations. Ms. Bonasso, a Canadian and Swiss citizen, holds a degree in Business Administration and a post-graduate superior specialized diploma in Public Accounting, both from HEC Montreal. She is a member of the Chartered Professional Accountants (CPA) of Canada and is a Certified Chartered Accountant.

Ms. Bonasso will be responsible for overseeing accounting, controlling and treasury activities. After an initial on-boarding period, Ms. Bonasso will assume the role of our principal accounting officer no later than June 1, 2021.

With respect to the disclosure required by Item 401(b) of Regulation S-K, there are no arrangements or understandings between Ms. Bonasso and any other person pursuant to which she will assume the role of our principal accounting officer. With respect to the disclosure required by Item 401(d) of Regulation S-K, there are no family relationships between Ms. Bonasso and any of our directors or executive officers. With respect to Item 404(a) of Regulation S-K, except as described herein, there are no relationships or related transactions between Ms. Bonasso and us that would be required to be reported.

In connection with Ms. Bonasso's appointment as Head of Finance & Group Controller, on December 18, 2020, we entered into an employment agreement with Ms. Bonasso, which sets forth the terms and conditions under which Ms. Bonasso will serve in this position. The employment agreement has no specific term and continues until terminated in accordance with the terms therein. Ms. Bonasso's current annual base salary for fiscal year 2021 will be Swiss Francs (CHF) 250,000. Ms. Bonasso's annual base salary will be reviewed by us from time to time.

Both we and Ms. Bonasso must give a minimum of six months’ prior notice to terminate her employment, other than for cause (as provided for in the employment agreement). Ms. Bonasso is obligated to refrain from competition with us and also refrain from soliciting our employees, suppliers or customers for a period of one year after her termination, unless that period is shortened by a period of leave. After notice to terminate has been given by Ms. Bonasso or us, all or part of the duration of the notice period of leave would be counted as part of the non-competition period. 

In addition to her salary, Ms. Bonasso is entitled to certain annual allowances and to benefits in accordance with our Swiss pension fund and insurance plans. Ms. Bonasso is eligible for an annual discretionary bonus equal to 25% of her base salary.

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On February 1, 2021, we entered into a change of control agreement with Ms. Bonasso. The purpose of the change of control agreement is to establish certain protections for Ms. Bonasso upon a qualifying termination of her employment in connection with a change of control of our company.

The change of control agreement provides that, if we terminate Ms. Bonasso's employment without "Cause" (as defined in the change of control agreement) or Ms. Bonasso terminates her employment for "Good Reason" (as defined in the change of control agreement) and, in either case, such termination occurs within 24 months following a "Change of Control" (as defined in the change of control agreement), then, subject to Ms. Bonasso executing and delivering to us a release and waiver of claims, she will receive a lump sum payment of the following:

any accrued obligations owed to her, which include: (i) any of her annual base salary earned through the effective date of termination that remains unpaid; (ii) any bonus payable with respect to any fiscal year which ended prior to the effective date of her termination of employment, which remains unpaid; and (iii) any expense reimbursement due to her on or prior to the date of termination which remains unpaid to her; and

a cash payment equal to 150% of the sum of her base salary plus target annual bonus in effect on the date of termination, without taking into effect any reduction in her annual base salary that may constitute "Good Reason" under the change of control agreement.

In addition, immediately prior to the effective date of termination, 100% of Ms. Bonasso's then outstanding, unvested equity awards, if any, will immediately vest and, if applicable, become exercisable (and any rights of repurchase by us or restriction on sale on Ms. Bonasso's then outstanding equity awards will lapse), and, following the effective date of termination, Ms. Bonasso's then outstanding equity awards, if any, will, if applicable, remain exercisable for a period of 12 months or until the expiration date of the equity award, whichever is the shorter period.

The change of control agreement will expire on February 1, 2024 and will automatically renew for successive one year terms unless our board of directors provides written notice of expiration of the change of control agreement at least 90 days prior to February 1, 2024 or the applicable anniversary thereof.

The above summary descriptions of certain terms contained in the employment agreement and the change of control agreement do not purport to be complete and are qualified in their entirety by reference to the full texts of the employment agreement and the change of control agreement, copies of which are filed as Exhibits 10.1 and 10.2, respectively, hereto.

Item 6. ExhibitsExhibits

The following is a list of exhibits filed as part of this Quarterly Report on Form 10-Q:

 

Exhibit No.

 

Description

 

4.1

 

 

Registration Rights Agreement, dated December 13, 2019 among the Company, Heino von Prondzynski, Franz Walt and Christopher Lindop (filed as exhibit 4.1 to our Current Report on Form 8-K filed on December 13, 2019 and incorporated herein by reference).

10.1

 

Lease extension agreementEmployment Agreement, dated October 2, 2019 among Quotient Limited, FidFund Management SA andDecember 18, 2020, between Quotient Suisse SA amending the lease agreement dated March 10, 2010 to extend the Company’s lease on its facility in Eysins, Switzerland to March 14, 2025and Vittoria Bonasso.

10.2

 

Transition Agreement, dated December 10, 2019, between the Company and Roland Boyd (filed as exhibit 10.1 to our Current Report on Form 8-K on December 13, 2019 and incorporated herein by reference).

10.3

Employment Agreement, dated September 3, 2018, between the Company and Ernest Larnach (filed as exhibit 10.2 to our Current Report on Form 8-K on December 13, 2019 and incorporated herein by reference).

10.4

Amendment No. 1 to Employment Agreement, dated December 12, 2019, between the Company and Ernest Larnach (filed as exhibit 10.3 to our Current Report on Form 8-K on December 13, 2019 and incorporated herein by reference).

10.5

Change of Control Agreement, dated November 8, 2019,February 1, 2021, between the Company and Ernest Larnach (filed as exhibit 10.4 to our Current Report on Form 8-K on December 13, 2019 and incorporated herein by reference).Vittoria Bonasso

10.6

Agreement among Ortho-Clinical Diagnostics Inc,, Quotient Suisse SA and QBD (QSIP) Limited (filed as exhibit 10.1 to our Current Report of Form 8-K filed on December 27, 2019 and incorporated herein by reference).

10.7†

Second Amendment to STRATEC Supply and Manufacturing Agreement, dated November 4, 2019, between STRATEC SE and QBD (QSIP) Limited.

 

31.1

 

 

Certification of Franz Walt, Chief Executive pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

31.2

 

 

Certification of Christopher Lindop,Peter Buhler, Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

32.1

 

 

Certification of Franz Walt, Chief Executive pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

32.2

 

 

Certification of Christopher Lindop,Peter Buhler, Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

101*

101

 

 

The following financial statementsinformation from the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2019,2020 filed with the SEC, formatted in XBRL (eXtensibleInline Extensible Business Reporting Language)Language (Inline XBRL): (i) Condensed Consolidated Balance Sheets (unaudited), (ii) Condensed Consolidated Statements of Comprehensive Loss (unaudited), (iii) Condensed Consolidated Statements of Changes in Shareholders’ Deficit (unaudited), (iv) Condensed Consolidated Statements of Cash Flows (unaudited) and (v) Notes to Condensed Consolidated Financial Statements, tagged as blocks of text and including detailed tags.Statements.

 

* XBRL information is furnished and not filed for purposes of Section 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934, and is not subject to liability under those sections, is not part of any registration statement, prospectus or other document to which it relates and is not incorporated or deemed to be incorporated by reference into any registration statement, prospectus or other document.104

 

Portions of this exhibit (indicated by asterisks) have been omittedCover Page Interactive Data File, formatted in accordance with the rules of the Securities and Exchange Commission.Inline XBRL (included as Exhibit 101).

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

QUOTIENT LIMITED

 

 

 

Date: February 4, 20202021

 

/s/ Franz Walt

 

 

Franz Walt

Chief Executive Officer

 

Date: February 4, 2021

/s/ Peter Buhler

Peter Buhler

Chief Financial Officer

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