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Oxford Immunotec

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Oxford Immunotec Reports Fourth Quarter and Full Year 2015 Financial Results

  • Fourth quarter revenue of$16.8 millionincreased 42% on a constant currency basis compared to prior year period
  • 2015 revenue of $62.8 million increased 33% on a constant currency basis compared to prior year
  • T-SPOT®.PRT assay made available in the United States as laboratory developed test (LDT)
  • Gained CE Mark for the T-SPOT.PRT assay

OXFORD, United Kingdom and MARLBOROUGH, Mass., March 01, 2016 (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 fourth quarter and full year 2015 financial results.

"We are pleased with our fourth quarter financial and operating results as well as the significant progress we made during 2015," said Dr.Peter Wrighton-Smith, Chief Executive Officer ofOxford Immunotec. "Our sales performance, driven by accelerated growth in all geographies,exceeded expectations. We are also excited by the progress we made in our pipeline during the year and look forward to the many growth opportunities for our business in the future.”

By revenue type, total revenues were, in millions:

Three Months Ended December 31, Full Year Ended December 31,
2015 2014 Percent
Change
2015 2014 Percent
Change
Product $ 8.2 $ 6.2 31 % $ 30.2 $ 25.4 19 %
Service 8.6 5.9 46 % 32.6 24.1 35 %
Total Revenue $ 16.8 $ 12.1 39 % $ 62.8 $ 49.5 27 %

By geography, total revenues were, in millions:

Three Months Ended December 31, Full Year Ended December 31,
Percent Change Percent Change
2015 2014 As
Reported
Constant
Currency(1)
2015 2014 As
Reported
Constant
Currency(1)
United States $ 8.4 $ 5.6 51 % 51 % $ 31.4 $ 22.5 39 % 39 %
Europe & ROW 1.8 1.8 -3 % 5 % 7.1 7.2 -2 % 10 %
Asia 6.6 4.7 40 % 45 % 24.3 19.8 23 % 33 %
Total revenue $ 16.8 $ 12.1 39 % 42 % $ 62.8 $ 49.5 27 % 33 %

(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.

Fourth Quarter 2015 Financial Results

Revenue for the fourth quarter of 2015 was$16.8 million, representing 39% growth over the fourth quarter 2014 revenue of$12.1 million. On a constant currency basis, revenue growth was 42% versus the prior year period.

2015 fourth quarter product revenue was$8.2 millionrepresenting a 31% increase from product revenue of$6.2 millionin the fourth quarter of 2014. The increase in product revenue was primarily attributable to volume growth in Asia. Service revenue for the fourth quarter of 2015 was $8.6 million, up 46% from the 2014 fourth quarter revenue of$5.9 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 Statesrevenue was$8.4 millionin the fourth quarter of 2015 representing 51% growth over the same period's revenue of$5.6 millionin the prior year. Growth was driven primarily by accelerated growth in the institutional segment and early contribution from the patient testing segment.

Europe& ROW revenue was$1.8 millionin the fourth quarter of 2015 representing a 3% decrease compared to fourth quarter of 2014. On a constant currency basis, Europe & ROW grew 5% versus the fourth quarter of 2014. Asiarevenue was$6.6 millionin the fourth quarter of 2015 representing 40% growth over 2014 fourth quarter revenue of$4.7 million. On a constant currency basis,Asiagrew 45% versus the fourth quarter of 2014. The increase was driven by continued growth in both China and Japan.

Gross profit for the fourth quarter of 2015 was$8.5 million, an increase of$1.9 millionover gross profit of$6.6 millionin the same period of 2014. Gross margin was 50.4%, a decrease of 4.3 percentage points from the gross margin of 54.7% in the fourth quarter of 2014. The decrease in gross margin was primarily due to an increased percentage of lower margin product sales volume in China and Japan, as well as the ongoing refinement of the full automation process in our Memphis laboratory.

Operating expenses were$14.7 millionin the fourth quarter of 2015, an increase of$1.4 millioncompared to$13.3 millionin the same period last year. The increase in operating expenses was primarily due to headcount increases related to both sales and marketing and general and administrative functions, as well as increased costs from clinical studies and legal fees during the quarter.

EBITDA for the fourth quarter was$(5.7) millioncompared to$(6.2) millionin the fourth quarter of 2014.Adjusted EBITDA was$(4.7) millionfor the fourth quarter compared to$(5.4) millionin the same period in 2014. Both EBITDA and Adjusted EBITDA are non-GAAP measures.

Net loss for the fourth quarter of 2015 was$6.4 million, or$0.29per share, compared to$6.7 million, or$0.39per share, in the fourth quarter of 2014. Net loss per share was based on 22,264,307 and 17,337,646 weighted average ordinary shares outstanding for the fourth quarters of 2015 and 2014, respectively.

Cash and cash equivalents were$83.7 millionas ofDecember 31, 2015compared to$88.5 millionas ofSeptember 30, 2015.

Full Year 2015 Financial Results

Revenue for the full year 2015 was$62.8 million, representing 27% growth over the full year 2014 revenue of$49.5 million. On a constant currency basis, revenue growth was 33% versus the prior year.

2015 full year product revenue was$30.2 millionrepresenting a 19% increase from product revenue of$25.4 millionin the full year 2014. The increase in product revenue was primarily attributable to volume growth in Asia. Service revenue for the full year 2015 was $32.6 million, up 35% from $24.1 million in the full year 2014. The increase in service revenue was primarily driven by increased volume, specifically in the institutional and patient testing segments, in the United States.

United Statesrevenue was$31.4 millionin the full year 2015 representing 39% growth compared to full year 2014 revenue of$22.5 million. Growth was driven primarily by accelerated growth in the institutional segment and early contribution from the patient testing segment.

Europe& ROW revenue was$7.1 millionin the full year 2015 representing a 2% decrease compared to full year 2014 revenue of$7.2 million. On a constant currency basis, Europe & ROW grew 10% versus the full year 2014. Asiarevenue was$24.3 millionin the full year 2015 representing 23% growth over full year 2014 revenue of$19.8 million. On a constant currency basis,Asiagrew 33% versus the full year 2014. The increase was driven by continued growth in both China and Japan.

Gross profit for the full year 2015 was$33.2 million, an increase of$7.7 millionover gross profit of$25.5 millionin the full year 2014. Gross margin was 52.9%, an increase of 1.4 percentage points from a gross margin of 51.5% in the full year 2014. The increase in gross margin was a consequence of driving operational efficiencies.

Operating expenses were$57.4 millionin the full year 2015, an increase of$10.0 millioncompared to$47.4 millionin the full year 2014. Operating expenses increased at a slower rate than revenue during the year. The increase was primarily due to company-wide headcount increases to support the Company’s growth, in particular, the expansion of our sales forces in the U.S. and Japan. In addition legal fees and costs from clinical studies increased during the year.

EBITDA for the full year 2015 was$(22.1) millioncompared to$(20.2) millionfor the full year 2014.Adjusted EBITDA was$(18.2) millionfor the full year 2015 compared to$(17.7) millionfor the full year 2014. Both EBITDA and Adjusted EBITDA are non-GAAP measures.

Net loss for the full year 2015 was$24.5 million, or$1.12per share, compared to$22.2 million, or$1.28per share, for the full year 2014. Net loss per share was based on 21,781,933 and 17,310,148 weighted average ordinary shares outstanding for the full years 2015 and 2014, respectively.

Business Outlook

We expect to report revenue of between$16.6and$17.3 millionfor the first quarter of 2016.

We expect to report full year 2016 revenue of between$74and$77 million, representing 18-23% year-over-year growth on both a reported and constant currency basis.

Conference Call

Oxford Immunotecwill host a conference call onTuesday, March 1, 2016at8:00 a.m. Eastern Timeto discuss its fourth quarter and full year 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 Statescallers and +1 (484) 365-2897 for international callers and reference confirmation code 55316515 approximately ten minutes prior to start time. To access the live audio webcast or subsequent archived recording, visit the Investor Relations section ofOxford Immunotec'swebsite atwww.oxfordimmunotec.com. The replay will be available on the Company's website for approximately 60 days.

AboutOxford 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.TBtest, which is used to test for tuberculosis infection. TheT-SPOT.TBtest 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.CMVtest and the T-SPOT.PRTtest are the Company's second and third products and part of a series of products intended for the transplantation market. In addition to these three products, the Company has an additional six 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 atwww.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 theSecurities and Exchange Commission. When evaluatingOxford Immunotec'sbusiness 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
ccrawley@oxfordimmunotec.com

For Investor Inquiries:
Rick Altieri
Chief Financial Officer
Oxford Immunotec
Tel: +1 (508) 573-9953
raltieri@oxfordimmunotec.com

Mark Klausner
Westwicke Partners
Tel: +1 (443) 213-0500
oxfordimmunotec@westwicke.com

Oxford Immunotec Global PLC
Condensed consolidated statements of operations
(unaudited)
Three months endedDecember31, Year endedDecember 31,
(in thousands, except share and per share data) 2015 2014 2015 2014
Revenue
Product $ 8,162 $ 6,215 $ 30,207 $ 25,407
Service 8,623 5,903 32,575 24,098
Total revenue 16,785 12,118 62,782 49,505
Cost of revenue
Product 3,585 2,418 13,297 11,225
Service 4,733 3,074 16,247 12,784
Total cost of revenue 8,318 5,492 29,544 24,009
Gross profit 8,467 6,626 33,238 25,496
Operating expenses:
Research and development 2,610 2,848 11,002 7,033
Sales and marketing 7,853 7,111 30,402 25,487
General and administrative 4,222 3,390 16,010 14,837
Total operating expenses 14,685 13,349 57,414 47,357
Loss from operations (6,218 ) (6,723 ) (24,176 ) (21,861 )
Other (expense) income:
Interest (expense) income, net (14 ) 52 (67 ) (52 )
Foreign exchange losses (110 ) (21 ) (143 ) (352 )
Other income 4 75 54 245
Loss before income taxes (6,338 ) (6,617 ) (24,332 ) (22,020 )
Income tax expense 52 75 146 154
Net loss $ (6,390 ) $ (6,692 ) $ (24,478 ) $ (22,174 )
Net loss per share attributable to ordinary shareholders—basic and diluted $ (0.29 ) $ (0.39 ) $ (1.12 ) $ (1.28 )
Weighted-average shares used to compute net loss attributable to ordinary shareholders—basic and diluted 22,264,307 17,337,646 21,781,933 17,310,148
Reconciliation of net loss to Adjusted EBITDA
(unaudited)
Three months endedDecember 31, Year endedDecember 31,
(in thousands) 2015 2014 2015 2014
Net loss $ (6,390 ) $ (6,692 ) $ (24,478 ) $ (22,174 )
Income tax expense 52 75 146 154
Interest expense, net 14 (52 ) 67 52
Depreciation and amortization 609 503 2,142 1,742
EBITDA (5,715 ) (6,166 ) (22,123 ) (20,226 )
Reconciling items:
Share-based compensation expense 903 762 3,485 2,521
Unrealized exchange losses (gains) 43 (56 ) (150 ) (53 )
Loss on change in fair value of warrants 22
Change in fair value of contingent purchase price consideration 54 34 202 72
Intangible assets impairment charge 34 419
Adjusted EBITDA $ (4,681 ) $ (5,426 ) $ (18,167 ) $ (17,664 )
Oxford Immunotec Global PLC
Condensed consolidated balance sheets
(unaudited)
December31,
(in thousands, except share and per share data) 2015 2014
Assets
Current assets:
Cash and cash equivalents $ 83,715 $ 50,165
Restricted cash 200
Accounts receivable, net 7,058 6,823
Inventory 7,099 6,425
Prepaid expenses and other 3,592 2,755
Total current assets 101,464 66,368
Restricted cash, non-current 80 192
Property and equipment, net 6,284 4,537
In-process research and development 1,782 2,399
Goodwill 45 50
Other intangible assets, net 179 273
Other assets 18 30
Total assets $ 109,852 $ 73,849
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable $ 3,799 $ 2,368
Accrued liabilities 9,949 7,070
Deferred income 1,654 1,993
Current portion of loans payable 79 137
Total current liabilities 15,481 11,568
Long-term portion of loans payable 386 454
Contingent purchase price consideration 1,293 1,218
Total liabilities 17,160 13,240
Shareholders’ equity:
Ordinary shares, £0.006705 nominal value; 36,183,293 and 40,103,528 shares authorized at December 31, 2015 and 2014, respectively, 22,549,488 and 17,614,650 shares issued and outstanding at December 31, 2015 and 2014, respectively 243 192
Additional paid-in capital 244,033 186,816
Accumulated deficit (146,307 ) (121,829 )
Accumulated other comprehensive loss (5,277 ) (4,570 )
Total shareholders’ equity 92,692 60,609
Total liabilities and shareholders’ equity $ 109,852 $ 73,849

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