Form 8-K Oxford Immunotec Global For: Nov 04

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November 4, 2014 7:31 AM EST

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�

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

�

FORM 8-K

�

CURRENT REPORT

Pursuant to Section�13 or 15(d)

of the Securities Exchange Act of 1934

�

Date of Report (date of earliest event reported): November 4, 2014

�

OXFORD IMMUNOTEC GLOBAL PLC

(Exact name of registrant as specified in its charter)

�

England and Wales

(State or other jurisdiction

of incorporation)

�

001-36200	98-1133710
(Commission File Number)	(IRS Employer Identification No.)

�

94C Innovation Drive, Milton Park, Abingdon OX14 4RZ, United Kingdom

(Address of principal executive offices)

�

Registrants telephone number including area code +44 (0)�1235 442780

�

Check appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

�

Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

�

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

�

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

�

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

�

Item�2.02 Results of Operations and Financial Condition.

�

On November 4, 2014, Oxford Immunotec Global PLC (the Registrant) issued a press release announcing its financial results for the third quarter of 2014.�The full text of the press release and the related attachment are furnished as Exhibit 99.1 hereto and incorporated herein by reference.

�

In accordance with General Instruction B.2 of Form 8-K, the information in this Item�2.02, and Exhibit 99.1 hereto, shall not be deemed filed for purposes of Section�18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Registrants filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing.

�

Item�9.01 Financial Statements and Exhibits.

�

(d) Exhibits

�

Exhibit Number	Exhibit Description
�	�
99.1	Press Release dated November 4, 2014, Oxford Immunotec Reports�Third Quarter 2014�Financial Results

�

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 hereunto duly authorized.

�

Date: November 4, 2014

�

OXFORD IMMUNOTEC GLOBAL PLC
�	�
By:	�	/s/ Richard M. Altieri
�	�	Richard M. Altieri
�	�	Chief Financial Officer

�

EXHIBIT INDEX

�

Exhibit Number	��	Exhibit Description
�	�
99.1	��	Press Release dated November 4, 2014, Oxford Immunotec Reports�Third Quarter 2014�Financial Results

�

Exhibit 99.1

�

November 4, 2014

�

Oxford Immunotec Reports Third Quarter 2014 Financial Results

�

�	2014 Third Quarter Revenue of $13.3 Million Increased 24% Compared to Prior Year

�

�	Asia Region had 41% Revenue Growth Over Prior Year

�

�	Net Loss was $6.1 Million for the Third Quarter

�

�	1 Millionth Test Processed by Oxford Diagnostics Laboratories in the United States

�

OXFORD, United Kingdom and MARLBOROUGH, Mass., November 4, 2014 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (NASDAQ: OXFD), a global, commercial-stage diagnostics company committed to improving patient care by providing advanced, innovative tests in the field of immunology, today announced third quarter 2014 financial results.

�

"We are pleased with our financial performance and the operational progress we made in the third quarter," said Dr. Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec. We were encouraged by our performance in the United States and Asia and are excited about the product pipeline we are building.

�

By revenue type, total revenues were, in millions:

�

Three Months Ended Sep. 30,

�

2014

�

2013

�

Change

�

Product

�

6.5

�

5.0

�

Service

�

6.8

�

5.7

�

Total Revenue

�

13.3

�

10.7

�

By geography, total revenues were, in millions:

�

Three Months Ended Sep. 30,

�

2014

�

2013

�

Change

�

United States

�

6.5

�

5.3

�

Europe and ROW

�

1.7

�

1.7

�

-1

Asia

�

5.1

�

3.7

�

Total Revenue

�

13.3

�

10.7

�

Third Quarter 2014 Financial Results

�

Revenue for the third quarter of 2014 was $13.3 million, representing 24% growth over the third quarter 2013 revenue of $10.7 million.

�

United States revenue was $6.5 million in the third quarter of 2014 representing 21% growth over the same periods revenue of $5.3 million in the prior year. Growth was primarily driven by the acquisition of new customers.

�

Europe and Rest of World revenue of $1.7 million in the third quarter of 2014 was essentially flat compared to the third quarter of 2013. The performance in this region is reflective of the more fragmented nature of this market and our investment priorities.

�

Asia revenue was $5.1 million in the third quarter of 2014 representing 41% growth over the 2013 third quarter of $3.7 million. Revenue growth from this geography is representative of the large market opportunity and strong adoption of our test in both China and Japan.

�

Gross profit for the third quarter of 2014 was $6.8 million, an increase of $1.0 million over gross profit of $5.8 million in the same period of 2013. Gross margin was 51.1%, a decrease of 2.9 percentage points in comparison to the gross margin of 54.0% in the third quarter of 2013. The decrease in gross margin was primarily due to currency effects, investments to increase capacity in our service lab and an increase in share-based compensation included in COGS. The majority of our product costs, including the kit cost component of our service cost of sales are denominated in Pounds Sterling while the majority of our revenues are recognized in U.S. Dollars and Japanese Yen, both of which have weakened against the Pound.

�

Operating expenses were $13.0 million in the third quarter of 2014, an increase of $5.0 million compared to $8.0 million in the same period last year. The increase in operating expenses was primarily a result of the expansion to our sales force and marketing personnel in the United States and Asia as well as increased research and development costs associated with our product pipeline.

�

EBITDA for the third quarter was $(5.5) million compared to $(2.7) million in the third quarter of 2013. Adjusted EBITDA was $(4.9) million for the third quarter compared to $(2.1) million in the same period in 2013. Both EBITDA and Adjusted EBITDA are non-GAAP measures.

�

Net loss for the third quarter of 2014 was $6.1 million or $0.35 per share compared to $3.2 million or $1.36 per share in the third quarter of 2013. Net loss per share was based on 17,333,441 and 2,331,990 weighted average ordinary shares outstanding for the third quarter of 2014 and 2013, respectively.

�

Cash and cash equivalents were $58.0 million as of September 30, 2014 compared to $65.8 million as of June 30, 2014, a decrease of $7.8 million.

�

Business Outlook

�

We expect to report revenue of between $11.6 and $12.1 million for the fourth quarter of 2014, and between $49.0 and $49.5 million for the full year of 2014. We expect our gross margin to continue to improve at a moderate pace in the upcoming quarters and that operating expenses will increase as we continue to invest in the business.

�

Conference Call

�

Oxford Immunotec will host a conference call on Tuesday, November 4, 2014 at 8:00 a.m. Eastern Time to discuss its third quarter 2014 financial results. The call will be concurrently webcast. To listen to the conference call on your telephone please dial, (855) 363-5047 for United States callers and +1 (484) 365-2897 for international callers and reference confirmation code 25979461, approximately ten minutes prior to start time. To access the live audio webcast or subsequent archived recording, visit the Investor Relations section of Oxford Immunotecs website at�http://www.oxfordimmunotec.com. The replay will be available on the Companys website for approximately 90 days.

�

About Oxford Immunotec

�

Oxford Immunotec Global PLC is a global, commercial-stage diagnostics company committed to improving patient care by providing advanced, innovative tests in the field of immunology. The proprietary T-SPOT^� technology platform measures the responses of specific immune cells, known as T cells, to inform the diagnosis, prognosis and monitoring of patients with immunologically controlled diseases. T cells are a central component of the human bodys immune system, and are implicated in the control and progression of many medical conditions, including certain types of infectious diseases, cancers and autoimmune diseases. The Companys initial product developed using the T-SPOT technology platform is the T-SPOT.TB�test, which is used to test for latent tuberculosis infection. The T-SPOT.TB�test has�been approved for sale in over 50 countries, including the United States, where it has received�pre-market approval from the Food and Drug Administration, Europe, where it has obtained a CE mark, as well as Japan and China. The Company is headquartered near Oxford, UK and in Marlborough, MA. Additional information can be found at www.oxfordimmunotec.com.

�

T-SPOT and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd.

�

Forward-Looking Statements

�

This release contains forward-looking statements, including statements regarding future revenues, expenses and the prospects for sales of our products. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, decisions by regulatory authorities, hospitals and other health care institutions, laboratories, physicians, patients and third party payers, as well as our ability to expeditiously and successfully expand our sales and distribution networks and the other factors described under the Risk Factors section in our filings with the Securities and Exchange Commission. When evaluating Oxford Immunotecs business and securities, investors should give careful consideration to these risks and uncertainties.

�

Forward-looking statements are based on current expectations and assumptions and currently available data and are neither predictions nor guarantees of future events or performance. You should not place undue reliance on forward-looking statements, which speak only as of the date of this presentation. We do not undertake to update or revise any forward-looking statements after they are made, whether as a result of new information, future events, or otherwise, except as required by applicable law.

�

CONTACTS:

�

For Media Inquiries:

Caroline Crawley

Oxford Immunotec

Tel: +44 1235 442796

[email protected]

�

For Investor Inquiries:

Rick Altieri

Chief Financial Officer

Oxford Immunotec

Tel: +1 (508) 573-9953

[email protected]

�

Mark Klausner

Westwicke Partners

Tel: +1 (443) 213-0500

[email protected]

�

SOURCE: Oxford Immunotec

�

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)

�

2014

�

2013

�

2014

�

2013

�

Revenue

�

Product

�

6,480

�

4,977

�

19,192

�

14,888

�

Service

�

6,845

�

5,749

�

18,195

�

13,671

�

Total revenue

�

13,325

�

10,726

�

37,387

�

28,559

�

Cost of revenue

�

Product

�

2,944

�

2,158

�

8,807

�

6,767

�

Service

�

3,568

�

2,773

�

9,710

�

7,398

�

Total cost of revenue

�

6,512

�

4,931

�

18,517

�

14,165

�

Gross profit

�

6,813

�

5,795

�

18,870

�

14,394

�

Operating expenses:

�

Research and development

�

1,946

�

579

�

4,185

�

1,583

�

Sales and marketing

�

7,468

�

3,325

�

18,376

�

9,557

�

General and administrative

�

3,567

�

4,084

�

11,447

�

8,457

�

Total operating expenses

�

12,981

�

7,988

�

34,008

�

19,597

�

Loss from operations

�

(6,168

)

�

(2,193

)

�

(15,138

)

�

(5,203

)

Other (expense) income:

�

Interest expense, net

�

(41

)

�

(139

)

�

(104

)

�

(256

)

Foreign exchange gains (losses)

�

(721

)

�

(331

)

�

Other income (expense)

�

(113

)

�

170

�

114

�

Loss before income taxes

�

(6,042

)

�

(3,166

)

�

(15,403

)

�

(5,301

)

Income tax expense

�

Net loss

�

(6,095

)

�

(3,181

)

�

(15,482

)

�

(5,336

)

�

Net loss per share attributable to ordinary shareholdersbasic and diluted

�

(0.35

)

�

(1.36

)

�

(0.89

)

�

(2.36

)

�

Weighted-average shares used to compute net loss attributable to ordinary shareholdersbasic and diluted

�

17,333,441

�

2,331,990

�

17,300,881

�

2,256,494

�

Note: 2013 share and per share amounts have been adjusted to reflect the Companys

1-for-6.705 reverse stock split which occurred in November 2013.

�

Reconciliation of net loss to Adjusted EBITDA

(unaudited)

�

Three months ended September 30,

�

Nine months ended September 30,

�

(in thousands)

�

2014

�

2013

�

2014

�

2013

�

Net loss

�

(6,095

)

�

(3,181

)

�

(15,482

)

�

(5,336

)

Income tax expense

�

Interest expense, net

�

139

�

104

�

256

�

Depreciation and amortization

�

479

�

306

�

1,239

�

863

�

EBITDA

�

(5,522

)

�

(2,721

)

�

(14,060

)

�

(4,182

)

�

Reconciling items:

�

Share-based compensation expense

�

734

�

1,759

�

Unrealized exchange losses (gains)

�

(164

)

�

609

�

(191

)

Loss on change in fair value of warrants

�

Change in fair value of contingent purchase price consideration

�

Adjusted EBITDA

�

(4,914

)

�

(2,060

)

�

(12,238

)

�

(4,296

)

�

Oxford Immunotec Global PLC

Condensed consolidated balance sheets

(unaudited)

�

�	�	September 30,		�	�	December 31,		�
(in thousands, except share and per share data)	�	2014		�	�	2013		�
Assets	�	�	�	�	�	�	�	�
Current assets:	�	�	�	�	�	�	�	�
Cash and cash equivalents	�	$	58,007	�	�	$	76,494	�
Restricted cash	�	�	146	�	�	�	87	�
Accounts receivable, net	�	�	5,211	�	�	�	4,754	�
Inventory	�	�	6,515	�	�	�	5,450	�
Prepaid expenses and other	�	�	2,155	�	�	�	2,242	�
Total current assets	�	�	72,034	�	�	�	89,027	�
Restricted cash, non-current	�	�	246	�	�	�	362	�
Property and equipment, net	�	�	4,463	�	�	�	2,964	�
In-process research and development	�	�	2,497	�	�	�		�
Goodwill	�	�	55	�	�	�		�
Other intangible assets, net	�	�	295	�	�	�	331	�
Other assets	�	�	26	�	�	�	60	�
Total assets	�	$	79,616	�	�	$	92,744	�
�	�	�	�	�	�	�	�	�
Liabilities and shareholders equity	�	�	�	�	�	�	�	�
Current liabilities:	�	�	�	�	�	�	�	�
Accounts payable	�	$	2,901	�	�	$	2,310	�
Accrued liabilities	�	�	6,177	�	�	�	6,936	�
Deferred income	�	�	1,699	�	�	�	1,540	�
Current portion of loans payable	�	�	170	�	�	�	170	�
Taxes payable	�	�		�	�	�	177	�
Total current liabilities	�	�	10,947	�	�	�	11,133	�
Long-term portion of loans payable	�	�	449	�	�	�	563	�
Contingent purchase price consideration	�	�	1,234	�	�	�		�
Other liabilities	�	�		�	�	�	296	�
Total liabilities	�	�	12,630	�	�	�	11,992	�
�	�	�	�	�	�	�	�	�
Shareholders equity:	�	�	�	�	�	�	�	�
Ordinary shares, �0.006705 nominal value; 40,103,528 and 25,189,285 shares authorized at September 30, 2014 and December 31, 2013, respectively, and 17,611,348 and 17,255,267 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively	�	�	192	�	�	�	188	�
Additional paid-in capital	�	�	186,053	�	�	�	183,967	�
Accumulated deficit	�	�	(115,137	)	�	�	(99,655	)
Accumulated other comprehensive loss	�	�	(4,122	)	�	�	(3,748	)
Total shareholders equity	�	�	66,986	�	�	�	80,752	�
Total liabilities and shareholders equity	�	$	79,616	�	�	$	92,744	�

�

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