News Article | April 19, 2017
OXFORD, United Kingdom and MARLBOROUGH, Mass., April 19, 2017 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions, today announced that it plans to release first quarter 2017 financial results prior to market open on Tuesday, May 2, 2017. Dr. Peter Wrighton-Smith, Chief Executive Officer, and Rick Altieri, Chief Financial Officer, will host a conference call to review the Company's results at 8:00 a.m. Eastern Time the same day. 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 8077049, 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. 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 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 Company's second product line is a range of assays for tick-borne diseases, such as Lyme disease, obtained through the acquisitions of Imugen and Immunetics. Also obtained through the acquisitions is the Company's third product line focused on screening for Babesia in donated blood, for which the Company is currently seeking FDA clearance. The T-SPOT.CMV test and the T-SPOT.PRT test are pipeline products as part of the Company's fourth intended product line focused on the transplantation market. In addition to these four product lines, the Company has additional active development programs in other immune-regulated conditions. 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. Immunetics is a trademark of Immunetics, Inc.
News Article | May 2, 2017
OXFORD, United Kingdom and MARLBOROUGH, Mass., May 02, 2017 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions, today announced first quarter 2017 financial results. “We are very pleased with our performance during the first quarter as we continued our evolution from a single-product company to a multi-product company,” said Dr. Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec. "Our core tuberculosis (TB) business grew in line with our expectations, with strong growth in the U.S. and Europe & ROW markets during the first quarter, and we saw a strong contribution from our newly acquired tick-borne disease franchise. As we move forward through the year, we will continue to focus on driving revenue growth and progressing the company towards profitability.” By revenue type, total revenues were, in millions: By indication, total revenues were, in millions: By geography, total revenues were, in millions: (1) 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. Revenue for the first quarter of 2017 was $21.5 million, representing 26% growth over the first quarter 2016 revenue of $17.1 million. On a constant currency basis, revenue growth was 27% versus the prior year period. Tuberculosis revenue for the first quarter of $18.5 million increased 8% over the prior year period. 2017 first quarter product revenue was $8.4 million, representing a 3% increase from product revenue of $8.1 million in the first quarter of 2016. The increase was primarily attributable to Europe & ROW TB growth and the sale of Immunetics tick-borne disease kits, offset by reduced revenue in Asia driven by order timing. Service revenue for the first quarter of 2017 was $13.1 million, up 46% from 2016 first quarter revenue of $9.0 million. The increase in service revenue was primarily driven by increased tuberculosis revenues in the United States as well as revenues from Imugen tick-borne disease services. United States revenue was $13.5 million in the first quarter of 2017, representing 55% growth over revenue of $8.7 million in the prior year period. The increase was due both to strong organic growth in our core tuberculosis business revenue as well as the additional contribution of our tick-borne disease revenues. Europe & ROW revenue was $1.8 million in the first quarter of 2017, representing a 12% increase compared to the first quarter of 2016. On a constant currency basis, Europe & ROW increased 22% versus the first quarter of 2016. The increase was primarily due to strong TB growth, particularly in the UK, and sales of Immunetics tick-borne disease kits. Asia revenue was $6.2 million in the first quarter of 2017, representing a decrease of 9% compared to 2016 first quarter revenue of $6.8 million. On a constant currency basis, Asia declined 8% versus the first quarter of 2016. The decline was due to the timing of orders in China. Gross profit for the first quarter of 2017 was $11.0 million, an increase of $2.1 million over gross profit of $8.9 million in the same period of 2016. Gross margin was 51.2%, a decrease of 110 basis points from the gross margin of 52.3% in the first quarter of 2016. The first quarter gross margin performance reflects a strong improvement in the underlying TB margins offset by the addition of tick-borne disease products, which carry a lower gross margin. Operating expenses were $18.0 million in the first quarter of 2017, an increase of $1.9 million compared to $16.1 million in the same period last year. The increase in operating expenses was largely due to the inclusion of operating expenses as a result of the Imugen and Immunetics acquisitions, as well as expenses related to ongoing patent litigation. In addition, in the first quarter we recorded a $2.4 million credit related to the change in fair value of contingent consideration associated with the acquisition of Immunetics. Net loss for the first quarter of 2017 was $8.1 million, or $0.36 per share, compared to $7.0 million, or $0.32 per share, in the first quarter of 2016. Net loss per share was based on 22,533,531 and 22,284,392 weighted average ordinary shares outstanding for the first quarters of 2017 and 2016, respectively. EBITDA for the first quarter was $(6.1) million compared to $(6.4) million in the first quarter of 2016. Adjusted EBITDA was $(7.1) million for the first quarter compared to $(5.8) million in the same period in 2016. Both EBITDA and Adjusted EBITDA are non-GAAP measures. We expect to report revenue of between $24.9 and $25.7 million for the second quarter of 2017. We continue to expect to report full year 2017 revenue of between $102 and $105 million, representing 19% - 22% year-over-year growth. We expect revenue to increase 21% to 24% for the year using constant exchange rates. Oxford Immunotec will host a conference call on Tuesday, May 2, 2017 at 8:00 a.m. Eastern Time to discuss its first quarter 2017 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 8077049 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. 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 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 Company's second product line is a range of assays for tick-borne diseases, such as Lyme disease, obtained through the acquisitions of Imugen and Immunetics. Also obtained through the acquisitions is the Company's third product line focused on screening for Babesia in donated blood, for which the Company is currently seeking FDA licensure. The T-SPOT.CMV test and the T-SPOT.PRT test are pipeline products as part of the Company's fourth intended product line focused on the transplantation market. In addition to these four product lines, the Company has additional active development programs in other immune-regulated conditions. 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. Immunetics is a trademark of Immunetics, Inc. This release contains forward-looking statements that involve risks and uncertainties, including statements about our 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 our products and other statements that are not historical facts. The forward-looking statements in this release are based on current expectations, assumptions and data available as of the date of this release and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements, including but not limited to: risks related to disruption of management time from ongoing business operations due to the integration of Imugen and Immunetics into the Company; the risk that the Company may fail to realize the benefits expected from the acquisitions; the risk that the integration of Imugen and Immunetics into the Company may not progress as anticipated; decisions by regulatory authorities, hospitals and other health care institutions, laboratories, physicians, patients and third party payers that could affect the Company's business and prospects; as well as our ability to expeditiously and successfully expand our sales and distribution networks. The risks included above are not exhaustive. Other factors that could adversely affect our business and prospects are described under the "Risk Factors" section in our filings with the Securities and Exchange Commission ("SEC"). Our filings are available for free by visiting the investor section of our 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. 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. (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.
PubMed | Imugen Inc., Nantucket Cottage Hospital, Hunterdon Medical Center Infectious Diseases, Hawthorn Medical Associates and Tufts University
Type: Journal Article | Journal: Clinics in laboratory medicine | Year: 2015
Borrelia miyamotoi disease (BMD) is a newly recognized borreliosis globally transmitted by ticks of the Ixodes persulcatus species complex. Once considered to be a tick symbiont with no public health implications, B miyamotoi is increasingly recognized as the agent of a nonspecific febrile illness often misdiagnosed as acute Lyme disease without rash, or as ehrlichiosis. The frequency of its diagnosis in the northeastern United States is similar to that of human granulocytic ehrlichiosis. A diagnosis of BMD is confirmed by polymerase chain reaction analysis of acute blood samples, or by seroconversion using a recombinant glycerophosphodiester phosphodiesterase enzyme immunoassay. BMD is successfully treated with oral doxycycline or amoxicillin.
Chowdri H.R.,Hawthorn Medical Associates |
Gugliotta J.L.,Hunterdon Medical Center |
Berardi V.P.,IMUGEN Inc. |
Goethert H.K.,Tufts University |
And 3 more authors.
Annals of Internal Medicine | Year: 2013
Background: The diverse tickborne infections of the northeastern United States can present as undifferentiated flu-like illnesses. In areas endemic for Lyme and other tickborne diseases, patients presenting with acute febrile illness with myalgia, headache, neutropenia, thrombocytopenia, and elevated hepatic aminotransferase levels are presumptively diagnosed as having human granulocytic anaplasmosis (HGA). Objective: To assign a cause for illness experienced by 2 case patients who were initially diagnosed with HGA but did not rapidly defervesce with doxycycline treatment and had no laboratory evidence of Anaplasma phagocytophilum infection. Design: Case report. Setting: 2 primary care medical centers in Massachusetts and New Jersey. Patients: 2 case patients acutely presenting with fever. Measurements: Identification of the causative agent by polymerase chain reaction and DNA sequencing. Results: Molecular diagnostic assays detected Borrelia miyamotoi in the peripheral blood of both patients. There was no evidence of infection with other tickborne pathogens commonly diagnosed in the referral areas. Limitation: One of the case patients may have had concurrent Lyme disease. Conclusion: The presence of B. miyamotoi DNA in the peripheral blood and the patients' eventual therapeutic response to doxycycline are consistent with the hypothesis that their illness was due to this newly recognized spirochete. Samples from tick-exposed patients acutely presenting with signs of HGA but who have a delayed response to doxycycline therapy or negative confirmatory test results for HGA should be analyzed carefully for evidence of B. miyamotoi infection. © 2013 American College of Physicians.
Young C.,Rhode Island Blood Center |
Young C.,Hasbro Childrens Hospital of Rhode Island |
Young C.,Imugen Inc. |
Young C.,Women and Infants Hospital |
And 32 more authors.
Transfusion | Year: 2012
BACKGROUND: Babesiosis is the most common transfusion-transmitted infection reported to the Food and Drug Administration (FDA). We developed and implemented the first laboratory-based blood donor screening program for Babesia microti to help reduce and prevent transfusion-transmitted babesiosis (TTB) and report results for the initial year. STUDY DESIGN AND METHODS: Selective B. microti donor screening was performed using real-time polymerase chain reaction (PCR) and indirect immunofluorescence assay (IFA) to reduce the incidence of TTB in neonates and pediatric sickle cell and thalassemia patients under an FDA-approved investigational new drug application. We compared the reports of TTB in these patients in the first 12 months of the study with those of patients who received unscreened blood from 2005 to 2010. RESULTS: There were 2113 units tested with 2086 negative results, 26 positive IFA results (1.23%), and one indeterminate PCR result (0.05%). No reported case of TTB occurred with any B. microti-screened unit transfused to the targeted patients (0/787 units) or to any patient who received the screened units (0/2086 units). Before screening, there were seven cases of TTB in neonates, sickle cell, and thalassemia patients from 6500 unscreened units (one case/929 units) and 24 cases in the total transfused population from 496,545 units distributed (one case/20,686 units). CONCLUSION: Implementation of B. microti IFA and PCR screening is compatible with blood center operations to provide tested units. While the results after 1 year are not powered to demonstrate a change in the rate of TTB after testing, they are encouraging. © 2012 American Association of Blood Banks.
Moritz E.D.,Red Cross |
Winton C.S.,Red Cross |
Johnson S.T.,Red Cross |
Krysztof D.E.,Red Cross |
And 7 more authors.
Transfusion | Year: 2014
BACKGROUND: Babesia microti, a transfusiontransmissible intraerythrocytic parasite, is increasing in frequency in the United States with no available FDAlicensed donor screening assay. We utilized investigational arrayed fluorescence immunoassay (AFIA) and polymerase chain reaction (PCR) to detect B. microti antibodies and DNA in blood donors. STUDY DESIGN AND METHODS: AFIA and real-time PCR were performed on frozen paired EDTA plasma (AFIA) and EDTA whole blood (PCR) samples collected from May to September 2010 to 2011 in nonendemic (Arizona [AZ] and Oklahoma [OK]), moderately endemic (Minnesota [MN] and Wisconsin [WI]), and highly endemic (Connecticut [CT] and Massachusetts [MA]) areas of the United States. AFIA utilized B. microti piroplasm as an antigen substrate; PCR primers and probes targeted the B. microti 18S ribosomal RNA gene. Data from AZ and OK were used to calculate specificity. All AFIA- or PCR-positive or -inconclusive donors were deferred, notified, and invited to participate in a follow-up study involving repeat testing and a demographic and risk-factor questionnaire. Recipient tracing was performed for any cellular component transfused at index, at subsequent donation, or within the prior 12 months. RESULTS: Testing of 13,269 paired samples included 4022 from AZ and OK, 4167 from MN and WI, and 5080 from CT and MA. B. microti antibody and/or DNA prevalences were 0.025% (95% confidence interval [CI], 0.00%-0.14%), 0.12% (95% CI, 0.04%-0.28%), and 0.75% (95% CI, 0.53%-1.03%) in the nonendemic, midendemic, and high-endemic regions, respectively. Specificities were 99.95% (95% CI, 99.82%-99.99%) at a 1-in-64 AFIA cutoff and 99.98% (95% CI, 99.86% 100.00%) at a 1-in-128 cutoff. CONCLUSIONS: B. microti prevalence followed expected geographical patterns. Screening was feasible with a performance comparable or superior to other infectious disease blood donor screening assays. © 2014 AABB.
Townsend R.L.,Red Cross |
Moritz E.D.,Red Cross |
Fialkow L.B.,Red Cross |
Berardi V.,IMUGEN Inc. |
Stramer S.L.,Red Cross
Transfusion | Year: 2014
Background Anaplasma phagocytophilum (AP), a tick-borne obligate intracellular bacterium, causes human granulocytic anaplasmosis (HGA) and has been implicated in seven transfusion-transmitted (TT)-HGA cases associated with red blood cells (RBCs). Here we report the first probable case of TT-HGA involving leukoreduced platelets (PLTs). Case Report A hospitalized male received 25 blood components (November 2012) before his death from trauma. Hospital testing confirmed HGA by peripheral blood smears; samples were also sent to IMUGEN, Inc. (Norwood, MA), for AP-polymerase chain reaction (PCR) and AP-immunoglobulin (Ig)M and IgG enzyme immunoassay. All 12 potentially transmitting donors provided follow-up samples.Results Recipient smears progressed from negative to predominantly positive 16 days posttransfusion; hospital-performed AP-PCR was positive on Day 22. IMUGEN sample testing was PCR positive and IgM and IgG negative 14 to 23 days posttransfusion. The recipient had no known AP risk factors. One of 12 donors of RBCs or PLTs (leukoreduced 5-day-old PLTs) provided six follow-up samples; all were strongly IgG positive and IgM negative; one was PCR-positive. The IgG-positive donor was a 52-year-old female from Hudson Valley, New York, an area endemic for AP. She reported tick bites in September to October 2012 with no travel outside New York. The donor remained asymptomatic and received no treatment. The cocomponent PLT unit was transfused to a 78-year-old male who died of causes unrelated to AP.Conclusions This eighth case of probable TT-HGA indicates that leukoreduced PLTs may be infectious. An antibody- and PCR-positive donor having prior tick exposure living in an endemic area was identified. PCR positivity and elevated IgG levels, which continue to exceed the assay's detectible range even in the absence of IgM, indicate active donor infection. © 2014 AABB.