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Table Of Contents

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 September 30, 2015 

 

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 001-36200

 


 

OXFORD IMMUNOTEC GLOBAL PLC

(Exact name of registrant as specified in its charter)

 

England and Wales

98-1133710

(State or other jurisdiction of

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

incorporation or organization)

 

 

 

94C Innovation Drive, Milton Park, Abingdon

OX14 4RZ, United Kingdom

 

Not Applicable

(Address of Principal Executive Offices)

(Zip Code)

 

+44 (0)1235 442780

(Registrant’s Telephone Number, Including Area Code)

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).

 

Yes     No

 

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

 

Large accelerated filer ☐

 

Accelerated filer ☒

 

Non-accelerated filer ☐

 (Do not check if a smaller

reporting company)

Smaller reporting company ☐

 

 

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 October 30, 2015, there were 22,538,047 Ordinary Shares, nominal value £0.006705, of Oxford Immunotec Global PLC outstanding.

  

  

Oxford Immunotec Global PLC

Form 10-Q

Quarterly Period Ended September 30, 2015 

 

TABLE OF CONTENTS 

 

PART I – FINANCIAL INFORMATION  

 

 

 

Item 1.

Financial Statements:

 4

 

 

 

 

Condensed consolidated balance sheets (unaudited) as of September 30, 2015 and December 31, 2014

4

 

 

 

 

Condensed consolidated statements of operations (unaudited) for the three and nine months ended September 30, 2015 and 2014

5

     

 

Condensed consolidated statements of comprehensive loss (unaudited) for the three and nine months ended September 30, 2015 and 2014

6

     

 

Condensed consolidated statements of cash flows (unaudited) for the nine months ended September 30, 2015 and 2014

7

     

 

Notes to the unaudited condensed consolidated financial statements

8

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

16

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

30

 

 

 

Item 4.

Controls and Procedures

30

 

 

 

PART II – OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

30

 

 

 

Item 1A.

Risk Factors

30

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

30

 

 

 

Item 3.

Defaults Upon Senior Securities

30

 

 

 

Item 4.

Mine Safety Disclosures

30

 

 

 

Item 5.

Other Information

30

 

 

 

Item 6.

Exhibits

30

 

 

 

Signatures

31

  

 

Special note regarding forward-looking statements

 

This Quarterly Report on Form 10-Q, and exhibits hereto, contains or incorporates by reference estimates, predictions, opinions, projections and other statements that may be interpreted as “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. 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 Part II, Item 1A, “Risk Factors,” but are also contained elsewhere in this Quarterly Report. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “would,” “could,” “should,” “intend,” “plan,” “contemplate,” “expect,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “target,” “potential,” “continue,” and “ongoing” and other comparable expressions intended to identify statements about the future, although not all forward-looking statements contain these identifying words. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, level of activity, performance or achievements to differ materially from those currently anticipated. Forward-looking statements are neither historical facts nor assurances of future performance. 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 that involve substantial risks and uncertainties. Such risks and uncertainties include, but are not limited to:

 

 

our history of losses, our ability to achieve or sustain profitability and our ability to manage our growth;

 

our ability to further develop, commercialize and achieve market acceptance of our current and future products;

 

our ability to obtain regulatory body clearance to market any of our products;

 

our ability to successfully develop and complete the acquired in process research and development, or IPR&D, program and profitably commercialize the underlying product candidates before our competitors develop and commercialize similar products, or at all;

 

continued demand for diagnostic products for tuberculosis and the development of new market opportunities;

 

our ability to compete successfully and to maintain and expand our sales network;

 

decisions by insurers and other third party payors with respect to coverage and reimbursements;

 

our dependence on certain of our customers, suppliers and service providers;

 

disruptions to our business, including disruptions at our laboratories and manufacturing facilities;

 

our ability to effectively use our current financial resources and our ability to obtain additional capital resources;

 

the integrity and uninterrupted operation of our information technology and storage systems;

 

the impact of currency fluctuations on our business;

 

our ability to make successful acquisitions or investments and to manage the integration of such acquisitions or investments;

 

our ability to retain key members of our management;

 

the impact of taxes on our business, including our ability to use net operating losses;

 

the impact of legislative and regulatory developments, including healthcare reform, on our business;

 

the impact of product liability, intellectual property and commercial litigation on our business;

 

our ability to comply with SEC reporting, antifraud, anti-corruption, environmental, health and safety laws and regulations;

 

our ability to maintain our licenses to sell our products around the world, including in countries such as China and the United States, including the several states requiring licensure;

 

our ability to protect and enforce our intellectual property rights;

 

our status as an emerging growth company and as an English company listing ordinary shares in the United States;

 

the volatility of the price of our share price, substantial future sales of our shares and the fact that we do not pay dividends; and

 

the impact of anti-takeover provisions under U.K. law and our articles of association.

 

 

You should refer to Part I, Item 1A, “Risk Factors” in our 2014 Annual Report on Form 10-K 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. 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.

 

Where you can find more information

 

We file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission. You can inspect, read and copy these reports, proxy statements and other information at the Securities and Exchange Commission’s Public Reference Room, which is located at 100 F Street, N.E., Washington, D.C. 20549. You can obtain information regarding the operation of the Securities and Exchange Commission’s Public Reference Room by calling the Securities and Exchange Commission at 1-800-SEC-0330. The Securities and Exchange Commission also maintains a website at www.sec.gov that makes available reports, proxy statements and other information regarding issuers that file electronically.

 

We make available free of charge on our corporate website at www.oxfordimmunotec.com (in the “Investors” section) copies of materials we file with, or furnish to, the Securities and Exchange Commission. By referring to our corporate website, www.oxfordimmunotec.com, we do not incorporate any such website or its contents into this Quarterly Report.

 

 

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

 

Oxford Immunotec Global PLC

Condensed consolidated balance sheets 

(unaudited)

 

 

   

September 30,

   

December 31,

 

(in thousands, except share and per share data)

 

2015

   

2014

 

Assets

               

Current assets:

               

Cash and cash equivalents

  $ 88,483     $ 50,165  

Restricted cash

    112       200  

Accounts receivable, net

    7,444       6,823  

Inventory

    6,473       6,425  

Prepaid expenses and other assets

    2,718       2,755  

Total current assets

    105,230       66,368  

Restricted cash, non-current

    80       192  

Property and equipment, net

    5,706       4,537  

In-process research and development

    1,832       2,399  

Goodwill

    46       50  

Other intangible assets, net

    278       273  

Other assets

    19       30  

Total assets

  $ 113,191     $ 73,849  
                 

Liabilities and shareholders’ equity

               

Current liabilities:

               

Accounts payable

  $ 3,213     $ 2,368  

Accrued liabilities

    7,886       7,070  

Deferred income

    1,686       1,993  

Current portion of loans payable

    127       137  

Taxes payable

    147        

Total current liabilities

    13,059       11,568  

Long-term portion of loans payable

    352       454  

Contingent purchase price consideration

    1,274       1,218  

Total liabilities

    14,685       13,240  
                 

Commitments and contingencies (Notes 2, 9 and 10)

               
                 

Shareholders’ equity:

               

Ordinary shares, £0.006705 nominal value; 36,183,293 shares authorized at September 30, 2015 and December 31, 2014, and 22,538,047 and 17,614,650 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively

    242       192  

Additional paid-in capital

    243,126       186,816  

Accumulated deficit

    (139,917 )     (121,829 )

Accumulated other comprehensive loss

    (4,945 )     (4,570 )

Total shareholders’ equity

    98,506       60,609  

Total liabilities and shareholders’ equity

  $ 113,191     $ 73,849  

 

See accompanying notes to these unaudited condensed consolidated financial statements.        

 

 

Oxford Immunotec Global PLC

Condensed consolidated statements of operations 

(unaudited)

 

   

Three months ended September 30,

   

Nine months ended September 30,

 

(in thousands, except share and per share data)

 

2015

   

2014

   

2015

   

2014

 

Revenue:

                               

Product

  $ 8,310     $ 6,480     $ 22,045     $ 19,192  

Service

    9,634       6,845       23,952       18,195  

Total revenue

    17,944       13,325       45,997       37,387  

Cost of revenue:

                               

Product

    3,757       2,944       9,712       8,807  

Service

    4,312       3,568       11,514       9,710  

Total cost of revenue

    8,069       6,512       21,226       18,517  

Gross profit

    9,875       6,813       24,771       18,870  

Operating expenses:

                               

Research and development

    3,187       1,946       8,392       4,185  

Sales and marketing

    7,381       7,468       22,549       18,376  

General and administrative

    4,137       3,567       11,788       11,447  

Total operating expenses

    14,705       12,981       42,729       34,008  

Loss from operations

    (4,830 )     (6,168 )     (17,958 )     (15,138 )

Other income (expense):

                               

Interest expense, net

    (19 )     (41 )     (53 )     (104 )

Foreign exchange gains (losses)

    476       76       (33 )     (331 )

Other (expense) income

    (64 )     91       50       170  

Loss before income taxes

    (4,437 )     (6,042 )     (17,994 )     (15,403 )

Income tax expense

    46       53       94       79  

Net loss

  $ (4,483 )   $ (6,095 )   $ (18,088 )   $ (15,482 )

Net loss per share attributable to ordinary shareholders—basic and diluted

  $ (0.20 )   $ (0.35 )   $ (0.84 )   $ (0.89 )

Weighted-average shares used to compute net loss attributable to ordinary shareholders—basic and diluted

    22,259,840       17,333,441       21,619,375       17,300,881  

 

See accompanying notes to these unaudited condensed consolidated financial statements. 

 

 

Oxford Immunotec Global PLC

Condensed consolidated statements of other comprehensive loss 

(unaudited)

 

   

Three months ended September 30,

   

Nine months ended September 30,

 

(in thousands)

 

2015

   

2014

   

2015

   

2014

 

Net loss

  $ (4,483 )   $ (6,095 )   $ (18,088 )   $ (15,482 )

Other comprehensive loss, net of taxes:

                               

Foreign currency translation adjustment, net of taxes

    (394 )     (672 )     (375 )     (374 )

Other comprehensive loss, net of taxes

    (394 )     (672 )     (375 )     (374 )

Total comprehensive loss

  $ (4,877 )   $ (6,767 )   $ (18,463 )   $ (15,856 )

 

See accompanying notes to these unaudited condensed consolidated financial statements. 

 

  

Oxford Immunotec Global PLC

Condensed consolidated statements of cash flows 

(unaudited)

 

   

Nine months ended September 30,

 

(in thousands)

 

2015

   

2014

 

Cash flows from operating activities

               

Net loss

  $ (18,088 )   $ (15,482 )

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation and amortization

    1,533       1,239  

Intangible asset impairment charge

    385        

Share-based compensation expense

    2,582       1,759  

Change in fair value of contingent purchase price consideration

    148       38  

Loss on change in fair value of warrants

          22  

Changes in operating assets and liabilities, net of acquisition:

               

Accounts receivable, net

    (721 )     (480 )

Inventory

    (162 )     (1,112 )

Prepaid expenses and other assets

    12       115  

Accounts payable

    770       290  

Accrued liabilities

    922       (751 )

Deferred income

    (258 )     191  

Net cash used in operating activities

    (12,877 )     (14,171 )

Cash flows from investing activities

               

Purchases of property and equipment

    (2,466 )     (2,567 )

Purchases of intangible assets

    (45 )     (17 )

Cash paid for acquisition, net of cash acquired

          (1,716 )

Decrease in restricted cash

    200       57  

Net cash used in investing activities

    (2,311 )     (4,243 )

Cash flows from financing activities

               

Proceeds from issuance of ordinary shares

    53,762        

Proceeds from exercise of share options and warrants

    14       13  

Payments on loan

    (107 )     (139 )

Net cash provided by (used in) financing activities

    53,669       (126 )

Effect of exchange rate changes on cash and cash equivalents

    (163 )     53  

Net increase (decrease) in cash and cash equivalents, excluding restricted cash

    38,318       (18,487 )

Cash and cash equivalents at beginning of period

    50,165       76,494  

Cash and cash equivalents at end of period

  $ 88,483     $ 58,007  
                 

Noncash investing and financing activities:

               

Warrants liability reclassified to additional paid-in capital upon exercise of warrants

  $     $ 318  

 

See accompanying notes to these unaudited condensed consolidated financial statements.     

 

 

 

Oxford Immunotec Global PLC

Notes to Unaudited Condensed Consolidated Financial Statements

September 30, 2015

 

1. Business and basis of presentation

 

Description of business

 

Oxford Immunotec Global PLC, or the Company, is a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions. The Company’s proprietary T-SPOT® technology platform allows it to measure the responses of specific immune cells to inform the diagnosis, prognosis and monitoring of patients with immune-regulated conditions. Substantially all of the Company’s revenue is currently derived from the sale of its T-SPOT.TB test, which is sold in two formats: an in vitro diagnostic kit format (allowing customers to perform the test at their own institutions), and a service format (in which the Company performs the test on samples sent by customers to the Company’s own laboratory facilities). The Company has a direct sales force in the United States, certain European countries and Japan and market development personnel in China. In parts of the world where the Company does not maintain a direct sales force, it markets and sells its products through distributors.

 

During the first quarter of 2015, the Company announced the availability in the United States of a new test, the T-SPOT.CMV test, that measures the strength of a patient's cellular immune response to cytomegalovirus infection, or CMV. The T-SPOT.CMV test was CE marked and made available in the European Union during the second quarter of 2015. CMV can affect individuals with weaknesses in their T cell response and is therefore an important and common cause of morbidity and mortality in solid organ and hematopoietic stem cell transplant recipients. The T-SPOT.CMV test is available in the United States as a laboratory developed test from the Company's Clinical Laboratory Improvements Amendment, or CLIA, certified and College of American Pathologists, or CAP, accredited service laboratory.

 

Unaudited interim financial statements

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, the interim consolidated financial statements reflect all adjustments of a normal recurring nature necessary for a fair statement of the financial position at September 30, 2015, the results of operations for the three and nine-month periods ended September 30, 2015 and 2014, and the cash flows for the nine-month periods ended September 30, 2015 and 2014. Interim results are not necessarily indicative of results for a full year.

 

The consolidated balance sheet presented as of December 31, 2014, has been derived from the audited consolidated financial statements as of that date. The consolidated financial statements and notes included in this report should be read in conjunction with the 2014 consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 5, 2015, or the Company’s 2014 Form 10-K.

 

Note 1 to the consolidated financial statements included in the Company’s 2014 Form 10-K describes the significant accounting estimates and policies used in preparing the consolidated financial statements. There have been no material changes in the Company’s significant accounting policies during the three and nine-month periods ended September 30, 2015.

 

Recent accounting pronouncements

 

In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers, or ASU 2014-09, which converges the FASB and the International Accounting Standards Board standards on revenue recognition. Under ASU 2014-09, a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. This guidance will be effective for the Company for annual and interim periods beginning after December 15, 2017. Early adoption is permitted for annual and interim periods beginning after December 15, 2016. The guidance allows for either “full retrospective” adoption, meaning the standard is applied to all of the periods presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements. The Company is currently evaluating ASU 2014-09 and has not yet determined how it may impact the Company’s financial position or results of operations and related disclosures.

 

 

In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern, or ASU 2014-15. ASU 2014-15 will be effective for fiscal years and interim periods beginning after December 15, 2016 and early application is permitted. ASU 2014-15 requires that management evaluate at each annual and interim reporting period whether there is a substantial doubt about an entity’s ability to continue as a going concern within one year of the date that the financial statements are issued. The Company does not expect that the application of ASU 2014-15 will have an impact on the presentation of its results of operations, financial position or disclosures.

 

In November 2014, the FASB issued ASU 2014-16, Derivatives and Hedging, or ASU 2014-16. The objective of ASU 2014-16 is to eliminate the existing diversity in practice in accounting for hybrid financial instruments issued in the form of a share. A hybrid financial instrument consists of a “host contract” into which one or more derivative terms have been embedded. ASU 2014-16 requires an entity to consider the terms and features of the entire financial instrument, including the embedded derivative features, in order to determine whether the nature of the host contract is more akin to debt or to equity. ASU 2014-16 is effective for fiscal years and interim periods beginning after December 15, 2015, with early adoption permitted. A reporting entity should apply ASU 2014-16 using a modified retrospective approach by recording a cumulative-effect adjustment to equity as of the beginning of the annual period of adoption. Retrospective application is permitted to all relevant prior periods. The adoption of ASU 2014-16 on January 1, 2015 had no impact on the Company’s presentation of its results of operations, financial position or disclosures.

 

In January 2015, the FASB issued ASU 2015-01, Income Statement—Extraordinary and Unusual Items, or ASU 2015-01. ASU 2015-01 eliminates from GAAP the concept of extraordinary items. However, the presentation and disclosure guidance for items that are unusual in nature or occur infrequently will be retained and will be expanded to include items that are both unusual in nature and infrequently occurring. The amendments in ASU 2015-01 are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. A reporting entity may apply the amendments prospectively. A reporting entity also may apply the amendments retrospectively to all prior periods presented in the financial statements. Early adoption is permitted provided that the guidance is applied from the beginning of the fiscal year of adoption. The adoption of ASU 2015-01 on January 1, 2015 had no impact on the Company’s presentation of its results of operations, financial position or disclosures.

 

In April 2015, the FASB issued ASU 2015-05, Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement, or ASU 2015-05. ASU 2015-05 amends existing accounting guidance to provide explicit guidance related to a customer’s accounting for fees paid in a cloud computing arrangement. Under the guidance, cloud computing arrangements that include a software license would be accounted for consistent with the acquisition of other software licenses. Conversely, cloud computing arrangements that do not include a software license would be accounted for as a service contract. This guidance will be effective for the Company for annual and interim periods beginning after December 15, 2015 and early adoption is permitted. The Company does not expect that the application of ASU 2015-05 will have an impact on the presentation of its results of operations, financial position or disclosures.

 

In July 2015, the FASB issued ASU 2015-11, Simplifying the Measurement of Inventory, or ASU 2015-11. ASU 2015-11 requires that an entity should measure inventory within the scope of ASU 2015-11 at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. This guidance will be effective for the Company for annual and interim periods beginning after December 15, 2016. The amendments in ASU 2015-11 are to be applied prospectively with earlier application permitted as of the beginning of an interim or annual reporting period. The Company does not expect that the application of ASU 2015-11 will have a material impact on the presentation of its results of operations, financial position or disclosures.

 

Under the U.S. Jumpstart our Business Startups Act, or the JOBS Act, 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 irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, we are subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

 

  

2. Fair value measurement

 

As a basis for determining the fair value of certain of the Company’s financial instruments, the Company utilizes a three-tier value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

 

Level I—Observable inputs such as quoted prices in active markets for identical assets or liabilities.

 

Level II—Observable inputs, other than Level I prices, 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 III—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

This hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. The carrying amount of certain of the Company’s financial instruments, including cash, accounts receivable, prepaid expenses and other assets, accounts payable, and accrued liabilities approximate fair value due to their short maturities.

 

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the entire fair value measurement requires management to make judgments and consider factors specific to the asset or liability.

 

The following tables present information about the balances of liabilities measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques it utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable such as quoted prices, interest rates, and yield curves. Fair values determined by Level 3 inputs are unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. The Company did not have any financial assets measured at fair value on a recurring basis.

 

           

Fair value measurements at September 30, 2015 using

 

(in thousands)

 

September 30,

2015

   

Quoted prices in active markets for identical assets
(Level
1)

   

Significant
other
observable
inputs
(Level 2)

   

Significant
u
nobservable
inputs
(Level 3)

 

Liabilities:

                               

Contingent purchase price consideration

  $ 1,274     $     $     $ 1,274  

Total

  $ 1,274     $     $     $ 1,274  

 

           

Fair value measurements at December 31, 2014 using

 

(in thousands)

 

December 31,

2014

   

Quoted prices in active markets for identical assets
(Level
1)

   

Significant
other
observable
inputs
(Level 2)

   

Significant
u
nobservable
inputs
(Level 3)

 

Liabilities:

                               

Contingent purchase price consideration

  $ 1,218     $     $     $ 1,218  

Total

  $ 1,218     $     $     $ 1,218  

 

 

On July 31, 2014, the Company acquired substantially all of the assets of Boulder Diagnostics, Inc., or Boulder, a privately owned company developing immunology-based assays for autoimmune and inflammatory conditions/diseases. The terms of the purchase agreement included contingent purchase price consideration consisting of future potential milestone payments totaling up to $6.1 million at any time on or prior to July 31, 2024. The milestone payments consist of completion of studies related to acquired technologies, development of diagnostic test kits, patient enrollment in an Institutional Review Board approved study, issuance of patents, and approvals or clearances by the U.S. Food and Drug Administration, or FDA. The fair value of future potential milestone payments was determined based upon a probability weighted analysis of expected future milestone payments to be made to the seller, which are considered as Level 3 inputs.

 

The following table provides a summary of changes in the fair value of the Company's Level 3 financial liabilities for the three and nine-month periods ended September 30, 2015:

 

(in thousands)

 

Three months

ended

September 30,

2015

   

Nine months

ended

September 30,

2015

 

Balance – beginning

  $ 1,219     $ 1,218  

Change in fair value of contingent purchase price consideration

    52       148  

Foreign currency adjustment

    3       (92 )

Balance – ending

  $ 1,274     $ 1,274  

 

The change in the fair value of the contingent purchase price consideration was due to the effect of the passage of time on the fair value measurement of future potential milestone payments related to the Boulder acquisition that is included in other income in the Company’s condensed consolidated statements of operations for the three and nine-month periods ended September 30, 2015.

 

Foreign currency adjustments are included in accumulated other comprehensive loss for the three and nine-month periods ended September 30, 2015.

 

3. Accounts receivable, net

 

Accounts receivable, net, consisted of the following as of: 

 

(in thousands)

 

September 30,

2015

   

December 31,

2014

 

Accounts receivable

  $ 7,845     $ 6,937  

Less allowance for uncollectible accounts receivable

    (401 )     (114 )

Accounts receivable, net

  $ 7,444     $ 6,823  

 

4. Inventory

 

Inventory consisted of the following as of: 

 

(in thousands)

 

September 30,

2015

   

December 31,

2014

 

Raw materials

  $ 3,390     $ 3,605  

Finished goods

    3,083       2,820  

Inventory, net

  $ 6,473     $ 6,425  

 

 

5. Accrued liabilities

 

Accrued liabilities consisted of the following as of:

 

(in thousands)

 

September 30,

2015

   

December 31,

2014

 

Employee related expenses

  $ 4,531     $ 3,348  

Royalties

    2,177       2,458  

Clinical trials

    261        

Professional services

    212       323  

Inventory

    86       88  

Rent

    55       196  

Other accrued liabilities

    564       657  

Total accrued liabilities

  $ 7,886     $ 7,070  

 

6. Share option and equity incentive plan

 

Net expense recognized related to share-based compensation was as follows:

 

   

Three months ended

September 30,

   

Nine months ended

September 30,

 

(in thousands)

 

2015

   

2014

   

2015

   

2014

 

Cost of revenue

  $ 147     $ 37     $ 386     $ 91  

Research and development

    56       20       166       30  

Sales and marketing

    302       242       725       593  

General and administrative

    489       435       1,305       1,045  

Total share-based compensation

  $ 994     $ 734     $ 2,582     $ 1,759  

 

In November 2013, in connection with the Company’s initial public offering, the Company adopted the 2013 Share Incentive Plan, or the 2013 Plan, which provides for the grant of share options, restricted shares, restricted share units, or RSUs, and other share-based awards to employees, officers, directors and consultants of the Company.

 

During the three-month period ended September 30, 2015, the Company granted to certain employees 15,650 share options with an exercise price of $14.08 per share under the 2013 Plan. The weighted-average grant date fair value related to share options granted under the 2013 Plan during the three-month period ended September 30, 2015 was $6.18 per share. During the nine month period ended September 30, 2015, the Company granted to certain employees 685,800 share options with exercise prices ranging from $14.08 to $14.61 per share under the 2013 Plan. The weighted-average grant date fair value related to share options granted under the 2013 Plan during the nine-month period ended September 30, 2015 was $6.41 per share. Share options generally vest based on the grantee’s continued service with the Company during a specified period following the vesting start date or, in rare instances, based on the achievement of performance or other conditions as determined by the Board of Directors, and expire after ten years.

 

During the nine month period ended September 30, 2015, the Company awarded to certain employees 108,563 RSUs with a weighted average grant date fair value of $14.25 per share under the 2013 Plan. The RSUs vest based on the grantee’s continued service with the Company during a specified period following grant as follows: 40% on the second anniversary of the grant date; 30% on the third anniversary of the grant date; and 30% on the fourth anniversary of the grant date. Share-based compensation expense for these RSUs is calculated based on the grant date market price of the shares and is being recognized over the vesting period.

 

For the three-month period ended September 30, 2015, the Company incurred shared-based compensation expense related to share options and restricted shares/RSUs of $636,000 and $358,000, respectively. For the three-month period ended September 30, 2014, the Company incurred shared-based compensation expense related to share options and restricted shares of $446,000 and $288,000, respectively.

 

  

For the nine-month period ended September 30, 2015, the Company incurred shared-based compensation expense related to share options and restricted shares/RSUs of $1.7 million and $841,000, respectively. For the nine-month period ended September 30, 2014, the Company incurred shared-based compensation expense related to share options and restricted shares of $1.1 million and $653,000, respectively.

 

As of September 30, 2015, there was $6.4 million and $5 million of total unrecognized compensation cost related to unvested share options and restricted shares/RSUs, respectively. These costs are expected to be recognized over weighted-average periods of 2.5 years for share options and 2.7 years for restricted shares/RSUs.

 

7. Share capital

 

On January 29, 2015, the Company entered into an underwriting agreement, or the Underwriting Agreement, with J.P. Morgan Securities LLC and Piper Jaffray & Co., as representatives of the several underwriters named therein, collectively, the Underwriters, relating to the public offering, or the Offering, of 4,255,319 ordinary shares, nominal value £0.006705, or the Shares, at an offering price to the public of $11.75 per Share, or the Offering Price. The Underwriters agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $11.045 per share. Under the terms of the Underwriting Agreement, the Company granted the Underwriters a 30-day option to purchase up to an additional 638,297 Shares, or the Option Shares, at the Offering Price, less underwriting discounts and commissions. On January 30, 2015, the Underwriters exercised their option to purchase the Option Shares in full. The gross proceeds to the Company from the sale of the Shares and the Option Shares were approximately $57.5 million and the Company received net proceeds of approximately $53.8 million after deducting underwriting discounts and commissions and estimated aggregate offering expenses payable by the Company. The Offering closed on February 4, 2015.

 

During the first nine months of 2015, 29,781 ordinary shares were issued upon the exercise of options. As of September 30, 2015, there were 36,183,293 ordinary shares authorized and 22,538,047 ordinary shares issued and outstanding.

 

8. Net loss per share

 

The following numbers of outstanding ordinary share options, unvested restricted shares and unvested restricted share units were excluded from the computation of diluted net loss per share for the periods presented because their effect would have been anti-dilutive:

 

   

Three months ended

September 30,

   

Nine months ended

September 30,

 
   

2015

   

2014

   

2015

   

2014

 

Options to purchase ordinary shares

    1,119,303       1,168,700       1,119,397       1,197,817  

Unvested restricted shares

    253,740       275,500       253,740       275,500  

Unvested restricted share units

    108,563             108,563        

 

9. Commitments and contingencies

 

In August 2015, the Company entered into a lease amendment for the Company’s location in Marlborough, Massachusetts to extend the term of the lease by two years through October 31, 2020. In addition, the lease amendment will expand the Company’s office space at this location by 7,600 square feet to a new total of 22,100 square feet. The base rent for the combined space over the lease term will range from an initial low of $36,000 per month, which includes $12,000 per month for the expansion space commencing in early 2016, to a high of $39,000 per month. The Company will have an option to extend the lease for one additional term of five years.

 

10. Acquisition

 

On July 31, 2014 (“date of the acquisition”), the Company acquired substantially all of the assets of Boulder, a privately owned company developing immunology-based assays for autoimmune and inflammatory conditions/diseases. The assets acquired primarily relate to assays for Lyme disease and gout and an assay to help select biologics for autoimmune disease based on monitoring and prognosis of drug response that was acquired in conjunction with the Boulder acquisition. As part of the transaction, Boulder transferred to the Company all shares of capital stock in its wholly-owned subsidiary, Boulder Diagnostics Europe GmbH, such that the Company has become the sole owner of Boulder Diagnostics Europe GmbH.

 

 

The terms of the purchase agreement provided for an upfront payment of $1.7 million and contingent purchase price consideration consisting of future potential milestone payments totaling up to $6.1 million in respect of the Lyme disease and gout assays at any time on or prior to July 31, 2024. The milestone payments consist of up to $400,000 for the completion of studies related to acquired technologies, up to $700,000 for the development of diagnostic test kits, $500,000 for the first patient enrolled in an Institutional Review Board approved study, up to $1.5 million for the issuance of patents, and up to $3.0 million for approvals or clearances by the U.S. Food and Drug Administration. The Company has determined that this liability is a Level 3 fair value measurement within the FASB’s fair value hierarchy and the fair value has been estimated to be $1.2 million on the date of acquisition based on significant assumptions, including the probabilities of milestone occurrence, the expected timing of milestone payments, and a discount rate of 15%. Such liability is adjusted to fair value at each reporting date, with the adjustment reflected in general and administrative expenses. See Note 2 “Fair value measurement” for information pertaining to changes in the fair value of this liability.

 

The acquisition of Boulder was accounted for under the acquisition method of accounting. Total consideration was (in thousands):

 

Cash consideration

  $ 1,724  

Estimated fair value of contingent consideration

    1,247  
         

Total consideration transferred

  $ 2,971  

 

$183,200 of the cash consideration has been placed in an escrow account for a period of 24 months as security for any undisclosed liabilities and as indemnification for certain items. The Company paid approximately $181,000 in transaction costs associated with this transaction, which is included in general and administrative expense in the consolidated statement of operations.

 

The following table summarizes the purchase price of the Boulder acquisition, the fair value of identified assets acquired and liabilities assumed at the acquisition date (in thousands):

 

Assets acquired:

       
         

Cash

  $ 8  

Accounts receivable

    15  

Inventory

    40  

Prepaid expenses and other

    12  

Property and equipment

    359  

In-process research and development

    2,627  
         

Total assets acquired

    3,061  
         

Liabilities assumed:

       
         

Accounts payable

    (97 )

Accrued liabilities

    (14 )

Other current liabilities

    (34 )
         

Total liabilities assumed

    (145 )
         

Net assets acquired

    2,916  
         

Add: goodwill

    55  
         

Total consideration transferred

  $ 2,971  

 

On the date of the acquisition the fair value of IPR&D acquired was determined to be $2.6 million ($1.8 million for the Lyme disease assay, $0.5 million for the assay to help select biologics for autoimmune disease based on monitoring and prognosis of drug response that was acquired in conjunction with the Boulder acquisition, and $0.3 million for the gout assay) using the excess earnings method with significant inputs, including estimates of the timing and cost required for product approval, revenue growth, gross margin, operating expenses and a 15% discount rate, that are not observable. The Company considers the fair value of IPR&D to be a Level 3 fair value asset due to the significant estimates and assumptions used by management in establishing the estimated fair value.

 

 

Goodwill and IPR&D are indefinite-lived intangible assets and are not amortized. Rather, they are reviewed for impairment at least annually. During the third quarter of 2015, the timeline for the development of an assay to inform decisions regarding biologic therapies that was acquired as part of the Boulder acquisition was changed due to delays in the completion of research studies. Based upon the changed timeline and the resulting impact on fair value, the Company recorded an IPR&D impairment charge of $385,000 in research and development expense.

 

Actual results of operations of Boulder for 2014 were included in the unaudited condensed consolidated interim financial statements from the date of the acquisition, including revenues in the amount of $17,000 for the quarter ended September 30, 2014 and losses from operations of $100,000 for the quarter ended September 30, 2014. The functional currency for Boulder in Germany is the Euro.

 

As a result of a restructuring during the fourth quarter of 2014 (see Note 11. “Restructuring”) the results of operations of Boulder for 2015 are immaterial.

 

Pro Forma Information: The unaudited pro forma condensed consolidated statement of operations of the Company, set forth below, gives effect to the Company’s acquisition of Boulder, using the acquisition method as if it occurred on January 1, 2014. These amounts are not necessarily indicative of the consolidated results of operations for future years or actual results that would have been realized had the acquisition occurred as of the beginning of 2014:

 

(in thousands, except share and per share data)

 

Three months

ended

September 30,

2014

   

Nine months

ended

September 30,

2014

 

Total revenues

  $ 13,335     $ 37,459  

Net loss

  $ (5,987 )   $ (15,707 )

Net loss per share—basic and diluted

  $ (0.35 )   $ (0.91 )

Weighted average shares outstanding—basic and diluted

  $ 17,333,441     $ 17,300,881  

 

11. Restructuring

 

During the fourth quarter of 2014, the Company closed the facilities that had been used by Boulder, terminated four employees, and consolidated the research and development activities that had been performed at those locations to the Company’s Abingdon, U.K. and Memphis, Tennessee facilities. As a result of these actions, the Company recorded a fourth quarter 2014 restructuring charge of $182,000 in research and development expense.

 

The following table provides a rollforward of the liability balance for these restructuring actions.

 

(in thousands)

 

Abandonment

of Excess Facilities

   

Relocation

Costs

   

Severance

   

Total

 

Balance at December 31, 2014

  $ 42     $ 28     $     $ 70  

(Credit) charge for restructuring

          (9 )     3       (6 )

Payments

    (42 )     (19 )     (3 )     (64 )

Balance at September 30, 2015

  $     $     $     $  

 

 

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

 

This management’s discussion and analysis of financial condition and results of operations contains forward-looking statements that involve risks and uncertainties. Please see “Cautionary note regarding forward-looking statements” in this Quarterly Report on Form 10-Q for a discussion of the uncertainties, risks and assumptions associated with these statements. You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and the related notes to those statements included elsewhere in this Quarterly Report. In addition to our historical consolidated financial information, the following discussion contains forward-looking statements that reflect our plans, estimates, beliefs and expectations. 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 in the Company’s 2014 Form 10-K, particularly in Part I, Item 1A, “Risk Factors.”

 

Overview

 

Oxford Immunotec Global PLC is a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions. Our proprietary T-SPOT® technology platform allows us to measure the responses of specific immune cells to inform the diagnosis, prognosis and monitoring of patients with immune-regulated conditions. Our current development activities are principally focused on four areas: chronic infections, transplantation, autoimmune and inflammatory disease and immune-oncology. We believe these areas are particularly attractive for the development of diagnostic tests because they involve large patient populations and chronic conditions that present the opportunity for both initial diagnosis and additional testing to monitor the conditions. These immune-regulated conditions also tend to be characterized by wide variation in presentation and progression and often require expensive therapies, making diagnostic tests that can better categorize patients and inform treatment pathways particularly useful. We believe the sensitivity of our T-SPOT technology platform, which can measure T cell and innate immune cell responses at a single cell level, well position us to bring new insights into the diagnosis, prognosis and monitoring of immune-regulated conditions.

 

The initial product we have developed using our T-SPOT technology platform is our T-SPOT.TB test, which is used to test for tuberculosis (TB) infection. Our T-SPOT.TB test has been approved for sale in over 50 countries, including the United States, where we have received premarket approval, or PMA, from the FDA, in Europe, where we have obtained a CE mark, as well as in Japan and China. Our T-SPOT.TB test has been included in clinical guidelines for TB screening in at least 17 countries, including the United States, several European countries and Japan. In addition, we have established reimbursement for our test in the United States, as well as a Current Procedural Terminology, or CPT, code that is unique to our test. Outside the United States, we have established reimbursement in several countries where reimbursement applies, including Japan, Switzerland and Germany. We have also established the cost-effectiveness of our test in several published studies.

 

During the first quarter of 2015, we announced the availability in the United States of a new test, the T-SPOT.CMV test, that measures the strength of a patient's cellular immune response to cytomegalovirus infection, or CMV. The T-SPOT.CMV test was CE marked and made available in the European Union during the second quarter of 2015. CMV can affect individuals with weaknesses in their T cell response and is therefore an important and common cause of morbidity and mortality in solid organ and hematopoietic stem cell transplant recipients. The T-SPOT.CMV test is available in the United States as a laboratory developed test from the Company's Clinical Laboratory Improvements Amendment, or CLIA, certified and College of American Pathologists, or CAP, accredited service laboratory. While we are enthusiastic about the potential clinical utility and economic value that the T-SPOT.CMV test may provide in transplant medicine, we are taking a measured approach to market introduction as we await the results of two pivotal clinical studies to provide the evidence needed to drive adoption and acceptance by the medical and payor communities of this test.

 

We also have seven active development programs pertaining to new potential tests. Each program seeks to exploit our T cell and innate immune measuring technology and cover each of our four focus areas.

 

Our T-SPOT.PRT, or Panel of Reactive T-cells, test is also based on our T-SPOT technology platform and assesses T cell responses to foreign tissue as a means of better informing organ rejection risk in current or potential transplant recipients.

 

Our development pipeline also includes an assay to assess the overall competence of the T cell side of the immune system, products targeting autoimmune and inflammatory diseases, such as gout and Lyme disease, and an assay informing the efficacy of biologic therapies. We also continue to explore applications of our T-SPOT technology platform in the immune-oncology space. These products are in earlier stages of development. Product development activities are inherently uncertain, and there can be no assurance that we will be able to obtain regulatory body clearance to market any of our products, or if we obtain clearances that we will successfully commercialize any of our products. In addition, we may terminate our development efforts with respect to one or more of our products under development at any time, including before or during clinical trials.

 

 

In April 2015, we entered into a First Amendment to Distributorship Agreement, or the Amendment, with Fosun Long March Medical Science Co. Ltd. and Shanghai Xin Chang Medical Device Co. Ltd., collectively the Distributors. The Amendment amends the Distributorship Agreement between the parties dated October 8, 2013, pursuant to which the Distributors purchase T-SPOT.TB test kits from us for distribution in China, or the Agreement. In accordance with the terms of the Amendment, we will provide the Distributors with a certain quantity of T-SPOT.TB test kits at no charge for use in the Distributors’ discount programs, subject to the achievement by the Distributors of certain minimum purchase requirements. The costs of these no charge tests will be recorded in cost of product revenue or in sales and marketing expense, based on the recipient.

 

In August 2015, we entered into a lease amendment for our location in Marlborough, Massachusetts to extend the term of the lease by two years through October 31, 2020. In addition, the lease amendment will expand our office space at this location by 7,600 square feet to a new total of 22,100 square feet. The base rent for the combined space over the lease term will range from an initial low of $36,000 per month, which includes $12,000 per month for the expansion space commencing in early 2016, to a high of $39,000 per month. We will have an option to extend the lease for one additional term of five years.

 

We have incurred significant losses from inception and as of September 30, 2015 had an accumulated deficit of $139.9 million. We anticipate that our operating losses will continue for the next few years as we continue to invest to grow our customer base and invest in research and development to expand our product portfolio. Our revenue for the three months ended September 30, 2015 was $17.9 million and for the three months ended September 30, 2014 was $13.3 million. Our revenue for the nine months ended September 30, 2015 was $46.0 million and for the nine months ended September 30, 2014 was $37.4 million. Our net loss for the three months ended September 30, 2015 was $4.5 million and for the three months ended September 30, 2014 was $6.1 million. Our net loss for the nine months ended September 30, 2015 was $18.1 million and for the nine months ended September 30, 2014 was $15.5 million.

 

Financial operations overview

 

Revenue

 

We generate revenue from sales associated with our T-SPOT technology platform via our direct sales force and also through distributors. Our T-SPOT.TB test is our first commercialized product based on this platform.

 

Revenue mix

 

We currently offer our T-SPOT.TB test as both an in vitro diagnostic kit and a service. In the former, we sell test kits and associated accessories to distributors for resale and directly to institutions and laboratories that perform TB testing. In the latter, we have established clinical testing laboratories in the United States and the United Kingdom, where we perform our T-SPOT.TB test on samples sent to us by customers. In these markets, we have found that many customers prefer to send samples to us rather than perform their own analysis on-site.

 

Our U.S. business derived 96% of its revenue from our service offering (as opposed to diagnostic kit sales) for each of the three month periods ended September 30, 2015 and 2014, which reflects our experience that U.S. customers prefer to send interferon-gamma release assay, or IGRA, tests out for processing and analysis rather than run them in-house. Our U.S. business also derived 96% of its revenue from our service offering for each of the nine month periods ended September 30, 2015 and 2014, respectively. For the majority of our U.S. customers in the hospital and public health segments, TB testing programs are funded primarily from institutional budgets. We receive payment from these customers according to our pre-negotiated prices. For other segments of the U.S. market (notably, for example, the physicians’ office segment) third-party reimbursement is often available to cover the cost of our T-SPOT.TB test. 

 

 

Outside the United States, we derived 92% our revenue from the sale of our in vitro diagnostic kits and associated accessories for each of the three month periods ended September 30, 2015 and 2014. These sales represented 92% and 91% of our revenue for the nine-month periods ended September 30, 2015 and 2014, respectively. For the majority of our customers outside the United States, we primarily negotiate pricing directly with our customers; our prices are influenced to some degree by the mechanism and level of funding our customers receive for performing tests for TB infection.

 

   

Three months ended

September 30,

   

Nine months ended

September 30,

 

(in thousands)

 

2015

   

2014

   

2015

   

2014

 

Revenue

                               

Product

  $ 8,310     $ 6,480     $ 22,045     $ 19,192  

Service

    9,634       6,845       23,952       18,195  

Total revenue

  $ 17,944     $ 13,325     $ 45,997     $ 37,387  

 

Revenue by geography

 

We have a direct sales force in the United States, certain European countries and Japan and market development personnel in China. During the third quarter of 2015, we modified the pricing aspects of our arrangement with our Japanese wholesaler and, as a result, price is now determinable upon shipment. Previously, price was determinable when the wholesaler dispatched the product. In parts of the world where we do not maintain a direct sales force, we market and sell our products through distributors. As a result, our revenue is denominated in multiple currencies. We intend to expand our sales force globally and establish additional distributor relationships outside of our direct markets to better access international markets.

 

The following tables reflect product revenue by geography (United States, Europe and rest of world, or Europe & ROW, and Asia) and as a percentage of total product revenue, based on the billing address of our customers.

 

   

Three months ended September 30,

 

(in thousands, except percentages)

 

2015

   

2014

 

Revenue

                         

United States

  $ 9,300       52 %   $ 6,476       49 %

Europe & ROW

    1,653       9 %     1,721       13 %

Asia

    6,991       39 %     5,128       38 %

Total revenue

  $ 17,944       100 %   $ 13,325       100 %

 

   

Nine months ended September 30,

 

(in thousands, except percentages)

 

2015

   

2014

 

Revenue

                         

United States

  $ 22,971       50 %   $ 16,967       45 %

Europe & ROW

    5,312       12 %     5,406       15 %

Asia

    17,714       38 %     15,014       40 %

Total revenue

  $ 45,997       100 %   $ 37,387       100 %

 

In 2014, we created new subsidiaries in Hong Kong and Shanghai, China, further expanding our presence in Asia.

 

Diagnostic products such as ours are subject to periodic re-registration in China. We completed the re-registration process for our T-SPOT.TB test with the China Food and Drug Administration, or CFDA, effective December 11, 2014. The registration will remain in effect until 2019.

 

Cost of revenue and operating expenses

 

Cost of revenue and gross margin

 

Cost of revenue consists of direct labor expenses, including employee benefits and share-based compensation expenses, overhead expenses, material costs, cost of laboratory supplies, freight costs, royalties paid under license agreements, U.S. medical device excise tax and depreciation of laboratory equipment and leasehold improvements. During the three months ended September 30, 2015 and 2014, our cost of revenue represented 45% and 49%, respectively, of our total revenue. For the nine months ended September 30, 2015 and 2014, our cost of revenue represented 46% and 50%, respectively, of our total revenue.

 

 

   

Three months ended

September 30,

   

Nine months ended

September 30,

 

(in thousands)

 

2015

   

2014

   

2015

   

2014

 

Cost of revenue

                               

Product

  $ 3,757     $ 2,944     $ 9,712     $ 8,807  

Service

    4,312       3,568       11,514       9,710  

Total cost of revenue

  $ 8,069     $ 6,512     $ 21,226     $ 18,517  

 

Our gross profit represents total revenue less total cost of revenue, and gross margin is gross profit expressed as a percentage of total revenue. Our gross margins were 55% and 51%, respectively, for the three months ended September 30, 2015 and 2014. Gross margins were 54% and 50%, respectively, for the nine months ended September 30, 2015 and 2014. The gross margin improvement was attributable to a reduction in material costs per test and efficiency from increased volume in our manufacturing operations and service laboratories, partially offset by the impact of foreign currency exchange rate changes and increased share-based compensation expense in 2015 compared to 2014.

 

We expect our overall cost of revenue to increase as we continue to increase our volume of kits manufactured and tests performed. However, we also believe that through these increased volumes, we can achieve certain efficiencies in our manufacturing and laboratory operations that could help maintain or improve our overall margins.

 

Research and development expenses

 

Our research and development efforts have historically focused on developing multiple new diagnostic tests that use our quantitative T cell measurement technology, including assays that would help transplant physicians better manage patients at risk of rejection and infection. We have expanded our research and development efforts since our initial public offering in November 2013 and, with the Boulder acquisition in July 2014, we are expanding our research and development efforts to include the development of immunology-based assays for autoimmune and inflammatory conditions/diseases.

 

Our research and development activities include performing research, development, clinical and regulatory activities and validating improvements to our technology and processes for the purposes of enhancing product performance. Research and development expenses include personnel-related expenses, including share-based compensation, fees for contractual and consulting services, clinical trial costs, travel costs, laboratory supplies, amortization, depreciation, rent, insurance, repairs and maintenance. In June 2014, we hired a Chief Medical Officer, or CMO. Since joining the Company, the CMO has supported the continued growth of our T-SPOT.TB business and expanded the team focused on the development of new products through management of clinical trial programs. In addition, we are expanding our research and development efforts in the United Kingdom and in Memphis, Tennessee. We expense all research and development costs as incurred.

 

During the three months ended September 30, 2015 and 2014, our research and development expenses represented 18% and 15%, respectively, of our total revenue. For the nine months ended September 30, 2015 and 2014, research and development expenses represented 18% and 11%, respectively, of our total revenue. These increases were primarily related to clinical studies, including the PROTECT study, which is a pivotal clinical trial designed to demonstrate the clinical value of our T-SPOT.CMV and T-SPOT.PRT products, and the REACT study, which focuses on stem cell transplant patients, and is the second of two pivotal clinical trials designed to demonstrate the clinical value of our T-SPOT.CMV test, as well as development project expenses related to our transplant program, to the hiring of personnel in the United States to support development programs and to projects acquired in the Boulder acquisition. During the third quarter of 2015, the timeline for the development of an assay to inform decisions regarding biologic therapies that was acquired as part of the Boulder acquisition was changed due to delays in the completion of research studies. Based upon the changed timeline and the resulting impact on fair value, we recorded an IPR&D impairment charge of $385,000 in research and development expense.

 

Sales and marketing expenses

 

Our sales and marketing expenses include costs associated with our sales organization, including our direct sales force and sales management, and our marketing, customer service and business development personnel. These expenses consist principally of salaries, commissions, bonuses and employee benefits for these personnel, including share-based compensation, as well as travel costs related to sales, marketing, customer service activities, medical education activities and overhead expenses. We expense all sales and marketing costs as incurred.

 

 

We continue to expand our operations in Asia. During 2014, we established two new subsidiaries in Asia: Oxford Immunotec Asia Limited, located in Hong Kong, and Oxford Immunotec (Shanghai) Medical Device Co. Ltd., located in Shanghai, China. In addition, we are expanding our sales force in Japan.

 

During the three months ended September 30, 2015 and 2014, our sales and marketing expenses represented 41% and 56%, respectively, of our total revenue. For each of the nine month periods ended September 30, 2015 and 2014, our sales and marketing expenses represented 49% of our total revenue. We expect our sales and marketing costs to increase, as we expand our sales force, business development activities, geographic presence, and marketing and medical education programs to increase awareness and adoption of our current T-SPOT.TB test and future products.

 

General and administrative expenses

 

Our general and administrative expenses include costs for our executive, accounting and finance, legal, information technology, or IT, and human resources functions. These expenses consist principally of salaries, bonuses and employee benefits for the personnel included in these functions, including share-based compensation and travel costs, professional services fees, such as consulting, audit, tax and legal fees, costs related to our Board of Directors, general corporate costs, overhead expenses, and bad debt expense. We expense all general and administrative expenses as incurred.

 

During the three months ended September 30, 2015 and 2014, our general and administrative expenses represented 23% and 27%, respectively, of our total revenue. For the nine months ended September 30, 2015 and 2014, our general and administrative expenses represented 26% and 31%, respectively, of our total revenue. Although general and administrative expense has declined in 2015 as a percentage of revenue, spending has increased in absolute terms largely as a result of higher salary costs, partially offset by lower legal costs.

 

Other income (expense)

 

Other income (expense) includes interest expense, net, foreign exchange gains and other income and expense items.

 

Monetary assets and liabilities that are denominated in foreign currencies are remeasured at the period-end closing rate with resulting unrealized exchange fluctuations. Realized exchange fluctuations result from the settlement of transactions in currencies other than the functional currencies of our businesses. The functional currencies of our businesses are U.S. Dollars, Pounds Sterling, Euros, Yen and the Yuan, depending on the entity.

 

 

 

Results of operations

 

Comparison of three months ended September 30, 2015 and 2014

 

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.

 

   

Three months ended September 30,

                 
   

2015

   

2014

   

Change

 

(in thousands, except percentages)

 

Amount

   

% of
revenue

   

Amount

   

% of
revenue

   

Amount

   

%

 

Revenue:

                                         

Product

  $ 8,310       46 %   $ 6,480       49 %   $ 1,830       28 %

Service

    9,634       54 %     6,845       51 %     2,789       41 %

Total revenue

    17,944       100 %     13,325       100 %     4,619       35 %

Cost of revenue:

                                         

Product

    3,757       21 %     2,944       22 %     813       28 %

Service

    4,312       24 %     3,568       27 %     744       21 %

Total cost of revenue

    8,069       45 %     6,512       49 %     1,557       24 %

Gross profit

    9,875       55 %     6,813       51 %     3,062       45 %

Operating expenses:

                                         

Research and development

    3,187       18 %     1,946       15 %     1,241       64 %

Sales and marketing

    7,381       41 %     7,468       56 %     (87 )     (1 )%

General and administrative

    4,137       23 %     3,567       27 %     570       16 %

Total operating expenses

    14,705       82 %     12,981       97 %     1,724       13 %

Loss from operations

    (4,830 )     (27 )%     (6,168 )     (46 )%     1,338       (22 )%

Interest expense, net

    (19 )     0 %     (41 )     0 %     22       (54 )%

Foreign exchange gains

    476       3 %     76       1 %     400       526 %

Other (expense) income

    (64 )     0 %     91       1 %     (155 )     (170 )%

Loss before income taxes

    (4,437 )     (25 )%     (6,042 )     (45 )%     1,605       (27 )%

Income tax expense

    46       0 %     53       0 %     (7 )     (13 )%

Net loss

  $ (4,483 )     (25 )%   $ (6,095 )     (46 )%   $ 1,612       (26 )%

 

 

Revenue 

 

Revenue increased by 35% to $17.9 million for the three months ended September 30, 2015 compared to $13.3 million for the same period in 2014. This increase in revenue was due to an increase in volumes across all regions where we sell our T-SPOT.TB test. U.S. revenue grew by 44%, to $9.3 million for the three months ended September 30, 2015, driven by growth of $1.8 million from the addition of new customers and $1.0 million from existing customers. Asia revenue grew by 36% to $7.0 million for the three months ended September 30, 2015 compared to the same period in 2014, due primarily to higher revenue in Japan and China. On a constant currency basis, revenue for Asia would have increased by 48%. Europe & ROW revenue decreased 4% to $1.7 million for the three months ended September 30, 2015 compared to the same period in 2014. On a constant currency basis, Europe & ROW revenue would have increased by 8% in 2015 compared to 2014.

 

   

Three months ended September 30,

   

Change

 

(in thousands, except percentages)

 

2015

   

2014

   

Amount

   

%

 

Revenue

                         

Product

  $ 8,310     $ 6,480     $ 1,830       28 %

Service

    9,634       6,845       2,789       41 %

Total revenue

  $ 17,944     $ 13,325     $ 4,619       35 %

 

   

Three months ended September 30,

   

Change

 

(in thousands, except percentages)

 

2015

   

2014

   

Amount

   

%

 

Revenue

                         

United States

  $ 9,300     $ 6,476     $ 2,824       44 %

Europe & ROW

    1,653       1,721       (68 )     (4 )%

Asia

    6,991       5,128       1,863       36 %

Total revenue

  $ 17,944     $ 13,325     $ 4,619       35 %

 

Cost of revenue and gross margin

 

Cost of revenue increased by 24% to $8.1 million for the three months ended September 30, 2015 from $6.5 million in the same period in 2014. This increase in cost of revenue was due to the increased volume of kits sold and an increase in volume of tests performed by our laboratories in the United States and the United Kingdom. Gross margin increased to 55% for the three months ended September 30, 2015 from 51% for the same period in 2014. The gross margin improvement was attributable to a reduction in material costs per test and efficiency from increased volume in our manufacturing operations and service laboratories, partially offset by the impact of foreign currency exchange rate changes and increased share-based compensation expense in 2015 compared to 2014.

 

   

Three months ended September 30,

   

Change

 

(in thousands, except percentages)

 

2015

   

2014

   

Amount

   

%

 

Cost of revenue

                         

Product

  $ 3,757     $ 2,944     $ 813       28 %

Service

    4,312       3,568       744       21 %

Total cost of revenue

  $ 8,069     $ 6,512     $ 1,557       24 %

 

Research and development expenses

 

Research and development expenses increased by 64%, to $3.2 million for the three months ended September 30, 2015, from $1.9 million for the same period in 2014. This increase reflects the fact that in 2014 we were just beginning to ramp-up our research and development activities following completion of our initial public offering in late 2013. The increased spending has primarily related to development project expenses for our transplant program and to the hiring of personnel in the United States to support development programs. And, with the acquisition of Boulder in the third quarter of 2014, we have expanded our research efforts to include assays for Lyme disease and gout.

 

 

Salary costs for research and development increased $473,000 in the third quarter of 2015 compared to the same period in 2014. In addition, the cost of clinical studies increased $387,000 in 2015 compared to 2014. As a percentage of total revenue, research and development expenses increased to 18% for the three months ended September 30, 2015 from 15% for the same period in 2014.

 

Sales and marketing expenses

 

Sales and marketing expenses decreased 1% to $7.4 million for the three months ended September 30, 2015 from $7.5 million for the same period in 2014. The decrease in 2015 compared to 2014 largely reflects a $757,000 decrease in marketing costs, including decreases of $343,000 in symposia, exhibitions, and medical education and $314,000 in market research, as well as a $238,000 decrease in recruiting and hiring costs, partially offset by a $761,000 increase in salary costs and an $110,000 increase in travel costs. As a percentage of total revenue, sales and marketing expenses decreased to 41% for the three months ended September 30, 2015 from 56% for the same period in 2014.

 

General and administrative expenses

 

General and administrative expenses increased by 16% to $4.1 million for the three months ended September 30, 2015 from $3.6 million for the same period in 2014. The increase in general and administrative expenses included increases of $533,000 for salary costs and $169,000 for recruiting and hiring costs in the third quarter of 2015 compared to the same period in 2014, partially offset by a $234,000 decrease in legal and professional fees in 2015 compared to 2014. As a percentage of total revenue, general and administrative expenses decreased to 23% for the three months ended September 30, 2015 from 27% for the same period in 2014. 

 

Interest expense, net

 

Interest expense, net was $19,000 for the three months ended September 30, 2015, compared to $41,000 in the same period in 2014. Interest expense in both periods primarily related to the fit out of our Marlborough facility.

 

Foreign exchange gains (losses)

 

We recorded foreign exchange gains of $476,000 for the three months ended September 30, 2015 as a net result of U.S. Dollar denominated bank accounts, accounts receivable, and accounts payable reflected on the books of Oxford Immunotec Limited, which has a functional currency of the U.K. Pound Sterling, during a period when the Pound was falling versus the Yen. For the three months ended September 30, 2014, we recorded foreign exchange gains of $76,000. We are exposed to foreign exchange rate risk because we currently operate in three major regions of the world: the United States, Europe & ROW, and Asia, and our revenue is denominated in multiple currencies. Approximately 52% of our sales were in the United States, which are denominated in U.S. Dollars. Sales in China are denominated in U.S. Dollars but these sales are made by our United Kingdom-based subsidiary where the Pound Sterling is the functional currency. As a result, these sales are subject to remeasurement into Pounds Sterling and then translation into U.S. Dollars when we consolidate our financial statements. Sales in Europe are denominated primarily in the Pound Sterling and Euro. As we grow Europe & ROW sales outside the United Kingdom and the Euro Zone, we may be subject to risk from additional currencies. Sales in Japan are denominated in Yen, and our sales in Japan, which started in late 2012, have since grown significantly.

 

Our expenses are generally denominated in the currencies in which our operations are located, which are primarily in the United States, the United Kingdom, Japan, Europe and China. 

 

As we continue to grow our business outside the United States, our results of operations and cash flows will be subject to fluctuations due to changes in foreign currency exchange rates, which could harm our business in the future. To date, we have not entered into any foreign currency hedging contracts, although we may do so in the future.

 

Other income (expense)

 

Other income (expense) was an expense of $64,000 for the three months ended September 30, 2015, compared to income of $91,000 in the same period in 2014.

 

 

Comparison of nine months ended September 30, 2015 and 2014

 

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 September 30,

                 
   

2015

   

2014

   

Change

 

(in thousands, except percentages)

 

Amount

   

% of
revenue

   

Amount

   

% of
revenue

   

Amount

   

%

 

Revenue:

                                               

Product

  $ 22,045       48 %   $ 19,192       51 %   $ 2,853       15 %

Service

    23,952       52 %     18,195       49 %     5,757       32 %

Total revenue

    45,997       100 %     37,387       100 %     8,610       23 %

Cost of revenue:

                                               

Product

    9,712       21 %     8,807       24 %     905       10 %

Service

    11,514       25 %     9,710       26 %     1,804       19 %

Total cost of revenue

    21,226       46 %     18,517       50 %     2,709       15 %

Gross profit

    24,771       54 %     18,870       50 %     5,901       31 %

Operating expenses:

                                               

Research and development

    8,392       18 %     4,185       11 %     4,207       101 %

Sales and marketing

    22,549       49 %     18,376       49 %     4,173       23 %

General and administrative

    11,788       26 %     11,447       31 %     341       3 %

Total operating expenses

    42,729       93 %     34,008       91 %     8,721       26 %

Loss from operations

    (17,958 )     (39 )%     (15,138 )     (40 )%     (2,820 )     19 %

Interest expense, net

    (53 )     0 %     (104 )     0 %     51       (49 )%

Foreign exchange (losses) gains

    (33 )     0 %     (331 )     (1 )%     298       (90 )%

Other income (expense)

    50       0 %     170       0 %     (120 )     (71 )%

Loss before income taxes

    (17,994 )     (39 )%     (15,403 )     (41 )%     (2,591 )     17 %

Income tax expense

    94       0 %     79       0 %     15       19 %

Net loss

  $ (18,088 )     (39