Report of Foreign Issuer (6-k)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of March, 2015

Commission File Number: 000-22320

 

 

TRINITY BIOTECH PLC

(Name of Registrant)

 

 

IDA Business Park

Bray, Co. Wicklow

Ireland

(Address of Principal Executive Office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  x             Form 40-F  ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes  ¨            No   x

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-            

 

 

 

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This Form 6-K contains (i) a press release related to the proposed offering of $100,000,000 Exchangeable Senior Notes due 2045 (the “Notes”) by Trinity Biotech Investment Limited, a wholly owned subsidiary of Trinity Biotech plc (the “Company”) and (ii) a copy of the corporate presentation of the Company. The information contained in this Form 6-K and in the exhibits attached hereto are being furnished to the Securities and Exchange Commission and shall not be deemed “filed” for purposes of the Securities Exchange Act of 1934, as amended, or incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

The following exhibits are attached:

 

Exhibit No.		Description of Exhibit
99.1		Press release: “Trinity Biotech plc Announces Proposed Offering of $100 Million of Exchangeable Senior Notes due 2045”
99.2		Corporate Presentation

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SIGNATURE

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, thereunto duly authorized.

 

TRINITY BIOTECH PLC
By:		/s/ Kevin Tansley
		Kevin Tansley
		Chief Financial Officer

Date: April 1, 2015

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EXHIBIT INDEX

 

Exhibit Number		Description
99.1		Press Release of Trinity Biotech plc, dated April 1, 2015
99.2		Corporate Presentation

Exhibit 99.1

Press Release dated April 1, 2015

Trinity Biotech plc Announces Proposed Offering of $100 Million of Exchangeable Senior Notes due 2045

DUBLIN, IRELAND – 04/01/15 Trinity Biotech plc (Nasdaq: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, announced today that Trinity Biotech Investment Limited, its wholly-owned subsidiary (the “Issuer”), intends to offer, subject to market and other considerations $100 million aggregate principal amount of Exchangeable Senior Notes due 2045 in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). In addition, the Issuer expects to grant to the initial purchasers of the notes a 30-day option to purchase up to an additional $15 million aggregate principal amount of the notes. The notes will mature on April 1, 2045, unless earlier purchased, redeemed or exchanged.

Trinity Biotech plc (the “Company”) currently expects to use the net proceeds from the offering for potential future acquisitions and for general corporate purposes, which may include continued product development and commercialization.

The notes will be senior unsecured obligations of the Issuer and will accrue interest from the date on which the notes are originally issued, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on October 1, 2015. The Issuer’s obligations under the notes will be fully and unconditionally guaranteed on a senior unsecured basis by the Company. The notes will be exchangeable at any time prior to the close of business on the second business day immediately preceding the maturity date for, and the Issuer will settle exchanges of the notes by delivering, American Depositary Shares (“ADSs”) of the Company (each representing, as of the date hereof, four “A” ordinary shares of the Company). The interest rate, exchange rate and other terms of the notes will be determined at the time of pricing of the offering.

The Issuer may not redeem the notes prior to April 1, 2020. On or after April 1, 2020, until, but excluding, April 1, 2022, the Issuer may from time to time redeem for cash all or part of the notes, but only if the last reported sale price per ADS for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on the trading day immediately preceding the date on which the Issuer provides the notice of redemption exceeds 130% of the applicable exchange price for the notes on each applicable trading day. On or after April 1, 2022, the Issuer may from time to time redeem for cash all or part of the notes, regardless of the last reported sale price per ADS. The redemption price will equal 100% of the principal amount of the notes being redeemed, plus accrued and unpaid interest to, but excluding, the redemption date, plus, for all notes redeemed prior to April 1, 2022, a “make-whole premium” payment payable in cash, ADSs or a combination of cash and ADSs, at the Issuer’s option, equal to the sum of the remaining scheduled payments of interest on the notes to be redeemed through April 1, 2022 (without duplication of the interest accrued to, but excluding, the redemption date). If the Issuer elects to pay some or all of the make-whole premium in ADSs, then the number of ADSs a holder will receive will be that number of ADSs that have a value equal to the amount of the make-whole premium payment to be paid to such holder in ADSs, divided by the product of (i) the average of the last reported sale price per ADS for the five trading days immediately preceding and including the third day prior to the redemption date and (ii) 0.97.

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Holders may require the Issuer to repurchase the notes on April 1, 2022, April 1, 2025, April 1, 2030, April 1, 2035 or April 1, 2040 at a price equal to 100% of the principal amount of the notes being repurchased, plus accrued and unpaid interest up to, but excluding, the repurchase date. The Issuer will pay cash for all notes so repurchased.

Neither the notes nor the ADSs issuable upon exchange of the notes have been or are expected to be registered under the Securities Act or under any state securities laws and, unless so registered, may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.

About Trinity Biotech plc

Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide.

Forward-Looking Statements

This press release includes forward-looking statements regarding Trinity Biotech’s financing plans, including statements related to the offering of the notes, the terms of the notes and the intended use of net proceeds of the offering. Such statements are subject to certain risks and uncertainties including, without limitation, risks related to whether the Company and the Issuer will consummate the offering of the notes on the expected terms, or at all, market and other general economic conditions, whether the Company and the Issuer will be able to satisfy the conditions required to close any sale of the notes, and the fact that the Company’s management will have broad discretion in the use of the proceeds from any sale of the notes. Trinity Biotech’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Trinity Biotech’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Trinity Biotech. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Trinity Biotech are described in additional detail in Trinity Biotech plc’s annual report on Form 20-F for the year ended December 31, 2014, which is on file with the Securities and Exchange Commission.

Your Diagnostics Partner March 2015 Nasdaq: TRIB POINT-OF-CARE | CLINICAL LABORATORY Exhibit 99.2

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains certain forward-looking statements. All statements other than statements of historical fact included in this presentation are forward-looking statements including, without limitation, all statements regarding future plans, business objectives, strategies, expected future financial position or performance, expected future operational position or performance, future competitive position or goals or projections of management for future operations. In some cases, you can identify a forward-looking statement by terminology such as “expected” or references to future growth rates or financial results The forward-looking statements contained in this presentation are largely based on our expectations and beliefs concerning future developments and their potential effect on us, which reflect certain estimates and assumptions made by our management. These estimates and assumptions reflect our judgment based on currently known market conditions, operating trends and other factors, and they are inherently uncertain and involve a number of risks and uncertainties that are beyond our control. As such, management’s assumptions about future events may prove to be inaccurate For a more detailed description of the known material factors that could cause actual results to differ from those in the forward-looking statements, see “Risk Factors” in our annual report on Form 20-F (available at www.sec.gov) Forward-Looking Statements 2

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Leading medical diagnostics company with brand recognition and global footprint Investment Summary 3 Significant expertise and success in developing and commercialising tests for multiple indications Profitable and growing business with no long-term debt obligations as of 31 December 2014 Generated 2014 sales of $105 million, representing 15% year-over-year growth Proven M&A expertise of executing and integrating synergistic acquisitions Near-term growth opportunities Growth in emergency medicine diagnostics with a focus on cardiac diagnostics Continued growth in Premier haemoglobin analyser business Significant new POC products including new rapid syphilis test

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Headquartered in Ireland, where the corporate tax rate is 12.5% Company Overview Principal offices located at IDA Business Park, Bray, Ireland Additional facilities located in: Jamestown, NY Buffalo, NY Carlsbad, CA Acton, MA Kansas City, MO Sao Paulo, Brazil Burlington, Canada Uppsala, Sweden 4 Facility Locations Worldwide Offers ~850 products used to detect autoimmune, infectious and sexually transmitted diseases, diabetes, and disorders of the liver and intestine Also operates as a provider of raw materials to the life sciences industry (Fitzgerald) Sell directly in the US (60 sales and marketing employees), Brazil and the UK Sales in a further ~100 countries through a distributor network

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Timeline 1992 2010 2012 2013 2015 Trinity Biotech has expanded its product portfolio through internal development and acquisitions over the past 20 years Incorporated in Ireland Completed IPO in the US Acquired Immco Diagnostics (Autoimmune diseases) Acquired blood bank screening business of Lab21 CE mark of Troponin I test and the BNP test Received CLIA waiver for the Syphilis Health Check Acquired Fiomi Diagnostics (POC cardiac assays) Launched the Premier laboratory system Sold Coagulation product line to Stago Diagnostica Employed ~345 people Currently employs ~545 people 2014 5

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Revenue Segments Revenue by Geography 2013 Revenue 2014 Revenue 58% 24% 18% 60% 26% 14% Americas Asia/Africa Europe Revenues 2013 2014 % Change Clinical Laboratory $68,727 $77,240 12.4% Point-of-Care 19,754 20,036 1.4% Laboratory Services 2,735 7,596 177.7% Total $91,216 $104,872 15.0% 6

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POC, which refers to diagnostic testing carried out in the presence of the patient, is a strategic priority and key growth segment of Trinity Biotech especially Emergency Medicine Point-of-Care Existing HIV offering – Significant market presence in Africa and US Rapid syphilis test – Newly CLIA waived with major market potential New Meritas platform focused on Cardiac (heart attack and heart failure) – Currently in FDA trials New range of POC products – Targeting S. pneumoniae, Legionella, H. pylori, C. difficile and syphilis 7

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Trinity Biotech’s African Market Trinity Biotech’s US Market $19 million in 2014 sales HIV Represents an estimated market size of  over $50 million Competitors: Orasure and Chembio Recent FDA approval for HIV-2 Supplies rapid HIV products under the President’s Emergency Plan for AIDS Relief  (PEPFAR) Market funded by the WHO, World Bank, Clinton & Gates Foundations, among other organisations Uni-Gold HIV serves as a gold standard product Confirmatory not screening 8

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POC syphilis test that delivers results in 12 minutes Only CLIA waived product on the market (received in December 2014) Target customers include: State public health departments Major city public health departments CDC funding CBO (community based organisations) Planned parenthood Excellent companion product for Trinity Biotech’s       Uni-Gold HIV test Both sold through Trinity’s existing US direct sales force New market with significant revenue opportunity Represents an estimated $10 million+ market opportunity Key Advantages Syphilis Health Check 9

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Targeting an estimated global POC cardiac market size of over $1 billion Platform technology and quantitative instrument for emergency medicine Meritas platform utilised for heart attack and heart failure diagnosis Consists of two components Microfluidic chip IP protected component providing controlled fluid flow for high assay precision Optical read-out module Provides high assay sensitivity Other applications include D-dimer, infectious diseases, autoimmune, allergy, veterinary and industrial segments Micropillar Array Cartridge Assembly Desk-Top Reader Cardiac – Trinity Biotech’s Technology : : 10

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Product CE Mark Estimated FDA Submission Troponin I Received Late 2015 BNP Received Late 2015 Meritas Troponin I Marker used for detecting acute myocardial infarctions Meritas BNP Marker used for detecting acute and chronic heart failure Competing products include Biosite Triage (Alere), Cobas (Roche) and i-Stat (Abbott) CE Mark/European Regulatory Approval for Troponin I received in January 2014 and BNP received in September 2014 Distributor network in Europe put into place                    with ongoing evaluations in Germany, France,                    UK, Spain and Italy FDA trials commenced in 1Q14 Trials temporarily suspended in October 2014 and resumed mid-February 2015 Cardiac – Trinity Biotech’s Technology : : Commenced D-dimer development - For diagnosis of deep vein thrombosis (“economy class syndrome”) Trinity understands that it is the first to submit under the new guidelines Troponin I FDA approval guidelines tightened 11

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Cardiac – POC Troponin I CE Mark Trial Results Product Characteristics Testing carried out in the emergency room with results patient-side in 15 minutes Tests run on Meritas analyser, which is cost efficient and size of a desk telephone Designed for ease of use, using a single drop of blood in a one-step process Demonstrated superior results with limit of detection of 19ng/L of whole blood and a CV of 10% at 36ng/L, which corresponds to 99th percentile of the reference population Time zero sensitivity of 60%, with specificity of 98% (CE Marking Study) Time zero sensitivity of 75%, with specificity of 93.6% (Independent clinical study by Dr. Fred Apple - Published July 2014) 12

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Trinity Biotech supplies the clinical laboratory segment of the in-vitro diagnostic market with a range of diagnostic tests and instrumentation Clinical Laboratory HbA1c for diabetes monitoring and diagnosis Hb Variants for the detection of Haemoglobin mutations Autoimmune diseases Infectious diseases mainly viral, bacterial, fungal and parasitic diseases A range of niche Clinical Chemistry products 13

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Targeting part of the $900 million A1c global testing market Major increase in incidence of diabetes in the US and internationally – Currently over 380 million diagnosed diabetics worldwide Haemoglobin A1c (A1c) is a long term indicator of diabetes management Diabetes A1c Superior indicator of a diabetic’s glycemic control Diabetics are recommended A1c testing 4 times a year Competitive Landscape Trinity Biotech (from 2012) Arkray Tosoh Bio-Rad 14

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Diabetes – Premier Instrument Interference free HPLC method (boronate affinity) Competitors such as Bio-Rad, Arkray and Tosoh suffer interference Capacity of up to 210 tests, one of the largest among competing products (100 tests) Results available in 1 minute enabling fast patient result turnaround times State-of-the-art software with touch screen Modular instrument which will significantly reduce the cost of on-site maintenance New Premier Resolution instrument for detection of sickle cell anaemia Major market opportunity Will target major worldwide labs including Quest and Lab Corp New-born testing Major tenders for         neo-natal won in Brazil Benefits 15

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Diabetes – Premier Western Europe – Distributed through Menarini Diagnostics, currently a market leader in A1c testing with over 100 instruments contracted annually U.S. – Utilises a direct sales force China (approved 2Q13) – Largest number of diabetics in the world (98 million) Brazil (approved 1Q14) – Served by direct sales force (over 100 instruments placed in first year post-approval) Turkey – Key market in which Trinity has had a long term presence Rest of World – Sales to the Andean region, Eastern Europe, Southeast Asia, Australia and Central America Market Presence 16

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Acquired in July 2013 for $33 million Based in Buffalo, NY and employs 99 people Consists of IFA products and EIA products Tests that detect lupus, Sjögren’s, celiac disease, Crohn’s and rheumatoid arthritis etc. Expected growth through leveraging synergies with Trinity Biotech and launch of laboratory-based tests Autoimmune Diseases – Immco Diagnostics Immco Diagnostics 17

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Autoimmune Diseases – Immco Diagnostics NYSDOH accredited reference laboratory New Sjögren’s product launched nationwide in June 2014 - Marketing partner Bausch & Lomb (reference laboratory) 4Q14 revenues over $500k Main competitors include Werfen-Inova, Bio-Rad and Phadia High organic growth 18

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Infectious Diseases and Blood Bank Screening Prominent niche player offering 60 products Large DSX instrument installed base in the US China represents a large growth market Developing new tests to add to portfolio including dengue, West Nile Virus and Chagas Trinity Biotech also offers blood bank screening products focusing on syphilis and malaria testing Represents a $4 million segment in 2014 Strong gross margins and cash generation $9 million of 2014 sales from Lyme confirmation business 19

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IFRS Summary 2012 2013 2014 Capitalised Development Costs $13,029 $18,390 $20,323 R&D Expenses 3,130 3,691 4,290 20 Trinity capitalises R&D expenditures on projects whose outcome has been assessed with reasonable certainty and charges the rest to the profit & loss account R&D is capitalised at cost within intangible assets and amortised over its expected useful life of the product Most of the Company’s R&D expenditures are capitalised

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Financial Information – Profit & Loss 2010 – 2012 EBITDASO, operating profit, profit after tax and EPS adjusted for consistency to show impact of Medical Device Excise Tax. 2010 excludes $46.4 million ($46.8 million net of tax) gain from divestment of Coagulation business and 2013 excludes one-time charges of $8.2 million ($7.5 million net of tax). ($ in millions) 2010* 2011* 2012* 2013 2014 Revenue $73.8 $77.9 $82.5 $91.2 $104.9 EBITDASO 17.5 19.1 21.2 22.8 24.0 Operating profit 13.6 15.3 16.6 17.2 18.0 Profit after tax 13.1 15.1 16.8 17.1 17.2 EPS (in US dollars) $0.62 $0.71 $0.78 $0.78 $0.76 Pre-launch cardiac costs Cost of duplicate UK manufacturing facilities (now closed) Lower sales within Lyme disease which typically attracts strong gross margins Increased sales of Premier instruments which have lower margins 21 Note: 2014 profit was partly impacted by: *

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Balance Sheet as of 31 December 2014 ($ in thousands) Financial Information – Balance Sheet 2014 Total Non-Current Assets $173,893 Cash and Cash Equivalents 9,102 Inventories 33,516 Trade and Other Receivables 25,976 Income Tax Receivables 351 Current Assets 68,945 Trade and Other Payables (21,197) Income Tax Payable (785) Provisions (75) Net Current Assets 46,888 Bank Debt $0 22

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Leading medical diagnostics company with ~850 products in its portfolio POC growth is a strategic focus for Trinity Biotech Significant near term growth opportunities with Premier, Premier Resolution, Syphilis Health Check, Sjögren’s and Meritas Cardiac platforms Expected FDA submission of Troponin I and BNP in 2015 Continued growth in Premier installed base - Strong placements since launch Profitable and cash generating infectious disease and autoimmune lab segments Growing and profitable business that enjoys a 12.5% tax rate in Ireland 2014 dividend of 22 cents per ADR Key Take Aways 23

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Profit & Loss (As Reported - IFRS) Note: 2010 includes $46.4 million ($46.8 million net of tax) gain from divestment of Coagulation business and 2013 includes one-time charges of $8.2 million ($7.5 million net of tax). ($ in millions) 2010 2011 2012 2013 2014 Revenue $89.6 $77.9 $82.5 $91.2 $104.9 Operating profit 60.5 15.8 17.2 9.0 18.0 Profit after tax 60.4 15.6 17.3 9.6 17.2 Earnings per ADS (US dollars) $2.85 $0.73 $0.81 $0.44 $0.76 Appendix 24