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EX-99.2 - EXHIBIT 99.2 - Oxford Immunotec Global PLCex_129090.htm
8-K - FORM 8-K - Oxford Immunotec Global PLCoxfd20181108_8k.htm

Exhibit 99.1

 

 

 

 

Oxford Immunotec Reports Third Quarter 2018 Financial Results

 

 

Closed transformative deal to sell U.S. laboratory services business to Quest Diagnostics

 

T-SPOT®.TB tests sold in the third quarter exceeded one million tests for the first time

 

Significant improvement in GAAP net loss; first quarter of positive non-GAAP adjusted EBITDA

 

OXFORD, United Kingdom and MARLBOROUGH, Mass., November 9, 2018 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq: OXFD), a global, high-growth diagnostics company, today announced third quarter 2018 financial results.

 

“We are very pleased with the continued strong growth in our TB business, as well as the Company’s continued progress on profitability metrics,” said Dr. Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec. “The Quest transaction is a transformative event for the Company that well positions us for greater commercial and financial success”.

 

By revenue type, total revenues were, in millions:

 

   

Three Months Ended September 30,

 
   

2018

   

2017

   

Percent

Change

 
                         

Product

  $ 15.1     $ 13.4       12 %

Service

    1.0       1.6       -40 %

Total Revenue

  $ 16.1     $ 15.0       7 %

 

By geography, total revenues were, in millions:

 

   

Three Months Ended September 30,

 
                   

Percent Change

 
   

2018

   

2017

   

As Reported

   

Constant Currency (a)

 
                                 

United States

  $ 2.9     $ 3.4       -15 %     -15 %

Europe & ROW

    2.3       2.2       3 %     4 %

Asia

    10.9       9.4       16 %     18 %

Total Revenue

  $ 16.1     $ 15.0       7 %     8 %

 

(a) Changes in revenue include the impact of changes in foreign currency exchange rates. We use the non-GAAP financial measure "constant currency basis" in our filings to show changes in our revenue without giving effect to period-to-period currency fluctuations. We consider the use of a period over period revenue comparison on a constant currency basis to be helpful to investors, as it provides a revenue growth measure free of positive or negative volatility due to currency fluctuations.

 

 

 

 

Third Quarter 2018 Financial Results

 

Revenue for the third quarter of 2018 was $16.1 million, representing a 7% increase from third quarter 2017 revenue of $15.0 million. On a constant currency basis, revenue growth was 8% versus the prior year period.

 

2018 third quarter product revenue was $15.1 million, representing a 12% increase from product revenue of $13.4 million in the third quarter of 2017. Service revenue for the third quarter of 2018 was $1.0 million, down 40% from 2017 third quarter service revenue of $1.6 million. The decrease in service revenue was driven by an expected decline in blood donor screening revenue.

 

United States revenue was $2.9 million in the third quarter of 2018, representing a 15% decline from revenue of $3.4 million in the prior year period. Growth in our core tuberculosis business was offset by an expected decline in blood donor screening revenue.

 

Europe & ROW revenue was $2.3 million in the third quarter of 2018, representing a 3% increase compared to the third quarter of 2017. On a constant currency basis, Europe & ROW revenue increased 4% versus the third quarter of 2017.

 

Asia revenue was $10.9 million in the third quarter of 2018, representing an increase of 16% compared to 2017 third quarter revenue of $9.4 million. On a constant currency basis, Asia revenue increased 18% versus the third quarter of 2017.

 

Gross profit for the third quarter of 2018 was $11.5 million, an increase of approximately $1.7 million from gross profit of $9.8 million in the same period of 2017. Gross margin was 71.5%, an increase of 650 basis points from gross margin of 65.0% in the third quarter of 2017.

 

Operating expenses were $16.5 million in the third quarter of 2018, a decrease of approximately $11.1 million compared to $27.6 million in the third quarter of 2017. Excluding one-time items, operating expenses for the third quarter of 2018 decreased approximately $900k compared to the third quarter of 2017.

 

Net loss for the third quarter of 2018 was $3.5 million, or $0.13 per share, compared to $16.8 million, or $0.70 per share, in the third quarter of 2017. Net loss per share was based on 26,033,550 and 24,123,574 weighted average ordinary shares outstanding for the third quarters of 2018 and 2017, respectively. 

 

EBITDA for the third quarter of 2018 was $(1.2) million compared to $(14.7) million in the third quarter of 2017. Adjusted EBITDA was $2.3 million for the third quarter of 2018 compared to $(2.5) million in the same period in 2017. Both EBITDA and Adjusted EBITDA are non-GAAP measures.

 

Quest Diagnostics Completes Acquisition of Our U.S. Laboratory Services Business

 

On November 6, 2018, Quest Diagnostics completed its previously announced acquisition of our U.S. laboratory services business. The T-SPOT.TB tuberculosis and the Accutix tick-borne disease testing services are now part of Quest Diagnostics’ portfolio of innovative infectious disease testing services. As part of the transaction, we will sell T-SPOT.TB test kits and related accessories to Quest Diagnostics under the terms of a long-term supply agreement. In addition, the parties have entered into a strategic collaboration agreement to drive continued growth of T-SPOT.TB testing in the U.S.

 

 

 

 

The transaction represents a strategic business shift having a major effect on our operations and financial results. Accordingly, the assets and liabilities of this business have been classified as held for sale and the related operations reported in discontinued operations in our condensed consolidated financial statements for all periods presented.

 

Supplemental Financial Information

 

To assist investors in understanding third quarter results excluding the disposition of the U.S. laboratory services business, Oxford Immunotec has provided Unaudited Non-GAAP Pro Forma Condensed Combined Statement of Operations for the quarterly period ended September 30, 2018 as Exhibit 99.2 to our Current Report on Form 8-K furnished on November 9, 2018.

 

Conference Call

 

Oxford Immunotec will host a conference call on Friday, November 9, 2018 at 8:00 a.m. Eastern Time to discuss its third quarter 2018 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 7673307 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, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions. The Company's 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, U.K. 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 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this release are forward-looking statements. This includes statements about Oxford Immunotec's anticipated plans, objectives, intentions, the anticipated benefits of the transaction, the effects of the transaction, including effects on future financial and operating results, prospects for sales of its products and other statements that are not historical facts. Actual events or results may differ materially from those described in this release due to a number of risks and uncertainties. Risks and uncertainties include, among others: the potential disruption of management time from ongoing business operations due to the transaction; the risk that Oxford Immunotec may fail to realize the expected benefits from the transaction; the risk that the announcement of the completion of the transaction could have adverse effects on the market price of Oxford Immunotec's ordinary shares; decisions by regulatory authorities, hospitals and other health care institutions, laboratories, physicians, patients and third party payers that could affect Oxford Immunotec's business and prospects; Oxford Immunotec’s exposure to potential litigation and contingent liabilities pursuant to the transaction; as well as Oxford Immunotec’s ability to expeditiously and successfully expand its sales and distribution networks. The risks included above are not exhaustive. Other factors that could adversely affect Oxford Immunotec's business and prospects are described under the "Risk Factors" section in its filings with the Securities and Exchange Commission ("SEC"). Oxford Immunotec's SEC filings are available for free by visiting the investor section of its website, www.oxfordimmunotec.com, or the SEC's website, www.sec.gov.

 

 

 

 

Investors should give careful consideration to these risks and uncertainties. Forward-looking statements contained herein 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 contained herein, which speak only as of the date of this release. Oxford Immunotec does 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 and Investor Inquiries:

Karen Koski

VP, Strategy and Investor Relations

Oxford Immunotec

Tel: +1 (508) 556-1377

kkoski@oxfordimmunotec.com

 

 

 

 

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)

 

2018

   

2017

   

2018

   

2017

 

Revenue:

                               

Product

  $ 15,095     $ 13,419     $ 40,236     $ 37,713  

Service

    955       1,592       4,150       4,411  

Total revenue

    16,050       15,011       44,386       42,124  

Cost of revenue:

                               

Product

    3,864       4,035       9,993       11,319  

Service

    709       1,212       2,877       3,513  

Total cost of revenue

    4,573       5,247       12,870       14,832  

Gross profit

    11,477       9,764       31,516       27,292  

Operating expenses:

                               

Research and development

    1,754       2,931       5,969       8,092  

Sales and marketing

    6,432       7,257       20,655       22,175  

General and administrative

    8,132       7,066       19,349       19,456  

Change in fair value of contingent purchase price consideration

          (880 )           (3,475 )

Intangible assets impairment charge

          11,064             11,064  

Settlement expense

    212       196       1,979       9,831  

Total operating expenses

    16,530       27,634       47,952       67,143  

Operating loss from continuing operations

    (5,053 )     (17,870 )     (16,436 )     (39,851 )

Other expense:

                               

Interest expense, net

    (673 )     (781 )     (2,011 )     (2,411 )

Foreign exchange losses

    (52 )     (624 )     (306 )     (1,277 )

Other income (expense)

    5             (242 )     (262 )

Loss from continuing operations before income taxes

    (5,773 )     (19,275 )     (18,995 )     (43,801 )

Income tax expense from continuing operations

    (485 )     (222 )     (1,182 )     2,189  

Loss from continuing operations

    (6,258 )     (19,497 )     (20,177 )     (41,612 )

Discontinued operations:

                               

Income (loss) from discontinued operations before income taxes

    2,774       2,650       (104 )     (73 )

Income tax expense

                       

Income (loss) from discontinued operations

    2,774       2,650       (104 )     (73 )

Net loss

  $ (3,484 )   $ (16,847 )   $ (20,281 )   $ (41,685 )
                                 

Net loss from continuing operations per ordinary share—basic and diluted

  $ (0.24 )   $ (0.81 )   $ (0.78 )   $ (1.80 )

Net income (loss) from discontinued operations per ordinary share—basic and diluted

    0.11       0.11       0.00       0.00  

Net loss per ordinary share—basic and diluted

  $ (0.13 )   $ (0.70 )   $ (0.78 )   $ (1.80 )

 

 

 

 

 

Reconciliation of net loss to Adjusted EBITDA (1)

(unaudited)

 

   

Three months ended September 30,

   

Nine months ended September 30,

 

(in thousands)

 

2018

   

2017

   

2018

   

2017

 

Net loss

  $ (3,484 )   $ (16,847 )   $ (20,281 )   $ (41,685 )

Income tax expense (benefit)

    486       222       1,183       (2,189 )

Interest expense, net

    534       641       1,590       1,982  

Depreciation and amortization of intangible assets

    1,167       1,122       3,410       3,115  

Accretion and amortization of loan fees

    140       140       421       429  

EBITDA

    (1,157 )     (14,722 )     (13,677 )     (38,348 )
                                 

Reconciling items:

                               

Share-based compensation expense

    1,016       1,506       3,763       4,266  

Unrealized exchange (gains) losses

    (234 )     333       (717 )     614  

Change in fair value of contingent purchase price consideration

          (880 )           (3,475 )

Intangible assets impairment charges

          11,064             11,064  

Settlement expense

    211       196       1,979       9,831  

Transaction expenses

    2,445             2,445        

Adjusted EBITDA

  $ 2,281     $ (2,503 )   $ (6,207 )   $ (16,048 )

 

(1) EBITDA and Adjusted EBITDA are non-GAAP measures that we calculate as net loss, adjusted for the impact of earnings or charges resulting from matters that we consider not to be indicative of our ongoing operations. We believe that these measures provide useful information to investors in understanding and evaluating our operating results in the same manner as our management and Board of Directors. Our presentation of these measures is not made in accordance with U.S. GAAP, and our computation of these measures may vary from others in the industry. Our use of these measures has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under U.S. GAAP.

 

The above table presents a reconciliation of net loss, the most comparable U.S. GAAP measure, to EBITDA and Adjusted EBITDA for each of the periods indicated.

 

 

 

 

Oxford Immunotec Global PLC

Condensed consolidated balance sheets

(unaudited)

 

   

September 30,

   

December 31,

 

(in thousands, except share and per share data)

 

2018

   

2017

 
   

(unaudited)

         

Assets

               

Current assets:

               

Cash and cash equivalents

  $ 70,156     $ 90,332  

Accounts receivable, net

    7,080       6,021  

Inventory, net

    6,114       7,137  

Prepaid expenses and other assets

    2,957       2,711  

Current assets held for sale

    31,899       14,281  

Total current assets

    118,206       120,482  

Restricted cash, non-current

    200       200  

Property and equipment, net

    6,428       2,764  

Goodwill

    2,483       2,483  

Other intangible assets, net

    958       1,036  

Deferred tax asset

    885       2,486  

Noncurrent assets held for sale

          14,785  

Total assets

  $ 129,160     $ 144,236  
                 

Liabilities and shareholders’ equity

               

Current liabilities:

               

Accounts payable

  $ 3,685     $ 5,552  

Accrued liabilities

    10,189       7,807  

Settlement liability

    4,530       4,342  

Deferred income

    31       36  

Current portion of loans payable

    30,200       78  

Current liabilities held for sale

    4,361       4,630  

Total current liabilities

    52,996       22,445  

Long-term portion of loans payable

    97       29,856  

Settlement liability

    4,064       3,894  

Other liabilities

          364  

Noncurrent liabilities held for sale

    37       48  

Total liabilities

    57,194       56,607  
                 

Shareholders’ equity:

               

Ordinary shares, £0.006705 nominal value; 36,183,293 shares authorized at September 30, 2018 and December 31, 2017, and 26,337,963 and 25,661,634 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively

    276       269  

Additional paid-in capital

    300,802       294,613  

Accumulated deficit

    (221,822 )     (201,541 )

Accumulated other comprehensive loss

    (7,290 )     (5,712 )

Total shareholders’ equity

    71,966       87,629  

Total liabilities and shareholders’ equity

  $ 129,160     $ 144,236