Form 8-K Oxford Immunotec Global For: Nov 03

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

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FORM 8-K

 

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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 3, 2015

 

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OXFORD IMMUNOTEC GLOBAL PLC

(Exact name of registrant as specified in its charter)

 

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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)

 

Registrant’s telephone number including area code +44 (0) 1235 442780

 

 

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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 3, 2015, Oxford Immunotec Global PLC (the “Registrant”) issued a press release announcing its financial results for the third quarter of 2015. 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, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Registrant’s filings under the Securities Act of 1933, as amended, 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 3, 2015, “Oxford Immunotec Reports Third Quarter 2015 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 3, 2015

 

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 3, 2015, “Oxford Immunotec Reports Third Quarter 2015 Financial Results”

 

 

 

4

Exhibit 99.1

 

 

Oxford Immunotec Reports Third Quarter 2015 Financial Results

 

	●	Third quarter revenue of $17.9 million increased 41% on a constant currency basis compared to prior year period
	●	Gross margin improved by 390 basis points compared to prior year period
	●	Two seasoned diagnostics executives appointed to the Board of Directors

 

OXFORD, United Kingdom and MARLBOROUGH, Mass., November 3, 2015 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq: OXFD), a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions, today announced third quarter 2015 financial results.

 

"We are very pleased with our third quarter financial and operating results," said Dr. Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec. "Our sales performance exceeded expectations, driven by strong growth in our United States and Asia geographies, and we are pleased with the progress we are making on our pipeline."

 

By revenue type, total revenues were, in millions:

 

		Three Months Ended September 30,
		2015				2014				Percent Change
Product		$	8.3			$	6.5				28	%
Service			9.6				6.8				41	%
Total revenue		$	17.9			$	13.3				35	%

 

By geography, total revenues were, in millions:

 

		Three Months Ended September 30,
										Percent Change
		2015				2014				As Reported				Constant Currency (1)
United States		$	9.3			$	6.5				44	%			44	%
Europe & ROW			1.6				1.7				-4	%			8	%
Asia			7.0				5.1				36	%			48	%
Total revenue		$	17.9			$	13.3				35	%			41	%

 

⁽¹⁾ We evaluate our revenue on both an as reported and a constant currency basis. The constant currency presentation, which is a non-GAAP measure, excludes the impact of fluctuations in foreign currency exchange rates.

 

 

Third Quarter 2015 Financial Results

 

Revenue for the third quarter of 2015 was $17.9 million, representing 35% growth over the third quarter 2014 revenue of $13.3 million. On a constant currency basis, revenue growth was 41% versus the prior year period.

 

2015 third quarter product revenue was $8.3 million representing a 28% increase from product revenue of $6.5 million in the third quarter of 2014. The increase in product revenue was primarily attributable to volume growth in Asia. Service revenue for the third quarter of 2015 was $9.6 million, up 41% from the 2014 third quarter of $6.8 million. The increase in service revenue was primarily driven by increased volume, specifically in the institutional and patient testing segments, in the United States.

 

United States revenue was $9.3 million in the third quarter of 2015 representing 44% growth over the same period's revenue of $6.5 million in the prior year. Growth was driven primarily by increases in the institutional and patient testing segments.

 

Europe & ROW revenue was $1.6 million in the third quarter of 2015 representing a 4% decrease compared to 2014 third quarter revenue of $1.7 million. On a constant currency basis, Europe & ROW grew 8% versus the third quarter of 2014. Asia revenue was $7.0 million in the third quarter of 2015 representing 36% growth over the 2014 third quarter revenue of $5.1 million. On a constant currency basis, Asia grew 48% versus the third quarter of 2014. The increase was driven by continued strong growth in both China and Japan.

 

Gross profit for the third quarter of 2015 was $9.9 million, an increase of $3.1 million over gross profit of $6.8 million in the same period of 2014. Gross margin was 55.0%, an increase of 390 basis points from the gross margin of 51.1% in the third quarter of 2014. The increase was primarily due to operational efficiencies associated with increased volume and operational improvements in our service business, partially offset by the impact of foreign currency exchange rate changes and increased share-based compensation charges in 2015 compared to 2014.

 

Operating expenses were $14.7 million in the third quarter of 2015, an increase of $1.7 million compared to $13.0 million in the same period last year. The increase in operating expenses was primarily due to headcount increases related to both research and development and sales and marketing, as well as increased costs from clinical studies performed during the quarter.

 

EBITDA for the third quarter was $(3.8) million compared to $(5.5) million in the third quarter of 2014. Adjusted EBITDA was $(2.0) million for the third quarter compared to $(4.9) million in the same period in 2014. Both EBITDA and Adjusted EBITDA are non-GAAP measures.

 

Net loss for the third quarter of 2015 was $4.5 million, or $0.20 per share, compared to $6.1 million, or $0.35 per share, in the third quarter of 2014. Net loss per share was based on 22,259,840 and 17,333,441 weighted average ordinary shares outstanding for the third quarters of 2015 and 2014, respectively. 

 

Cash and cash equivalents were $88.5 million as of September 30, 2015 compared to $90.4 million as of June 30, 2015.

 

 

Business Outlook

 

We expect to report revenue of between $15.9 and $16.7 million for the fourth quarter of 2015.

 

We expect to report full year 2015 revenue of between $61.9 and $62.7 million, representing 25%-27% year-over-year growth. We expect revenue to increase 31% to 32% for the year using constant exchange rates.

 

Board of Directors Appointments

 

On November 3, 2015, the Company announced that seasoned diagnostics executives Ronald Andrews Jr. and A. Scott Walton will join the Company’s Board of Directors effective November 4, 2015. The addition of Mr. Andrews and Mr. Walton to Oxford Immunotec’s Board of Directors increases the total number of directors to eight.

 

Conference Call

 

Oxford Immunotec will host a conference call on Tuesday, November 3, 2015 at 8:00 a.m. Eastern Time to discuss its third quarter 2015 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 65863291, approximately ten minutes prior to start time. To access the live audio webcast or subsequent archived recording, visit the Investor Relations section of Oxford Immunotec's website at www.oxfordimmunotec.com. The replay will be available on the Company's website for approximately 60 days.

 

About Oxford Immunotec

 

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. The Company's first product is the T-SPOT^®.TB test, which is used to test for 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 T-SPOT.CMV test is the Company's second product and the first in a series of products intended for the transplantation market. Overall, the Company has seven active development programs, each of which leverages our T cell, B cell and innate immune measuring technology. The Company is headquartered near Oxford, U.K. and in Marlborough, Mass. 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 Immunotec's 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)		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

 

 

Reconciliation of net loss to Adjusted EBITDA

(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	)
Income tax expense			46				53				94				79
Interest expense, net			19				41				53				104
Depreciation and amortization			597				479				1,533				1,239
EBITDA			(3,821	)			(5,522	)			(16,408	)			(14,060	)
Reconciling items:
Share-based compensation expense			994				734				2,582				1,759
Unrealized exchange losses (gains)			422				(164	)			(193	)			3
Loss on change in fair value of warrants			—				—				—				22
Change in fair value of contingent purchase price consideration			52				38				148				38
Intangible asset impairment charge			385				—				385				—
Adjusted EBITDA		$	(1,968	)		$	(4,914	)		$	(13,486	)		$	(12,238	)

 

 

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			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
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

 

 

 

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