TRINITY BIOTECH PLC [TRIB] Filings

---

 

---

---

 

 

 

 

 

 

 

 

 

 

 

---

 

 

---

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer ☒

Emerging growth company ☐

 

 

 

 

 

 

 

 

 

 

 

---

•

the development of our products;

•

the potential attributes and benefit of our products and their competitive position;

•

our ability to successfully commercialize, or enter into strategic relationships with third parties to commercialize, our products;

•

the duration of our patent portfolio.

Item 1.

Identity of Directors, Senior Management and Advisers

Item 2.

Offer Statistics and Expected Timetable

Item 3.

Key Information

A.

Reserved

B.	Capitalization and Indebtedness

C.	Reasons for the Offer and Use of Proceeds

•

our ability to sell products could be adversely affected by competition from new and existing diagnostic products, changing conditions in the diagnostic market, including, inter alia, reductions in government funding and sector consolidation.

•

our exclusion from one or more HIV testing algorithms, or a delay in the implementation of a HIV testing algorithm, could adversely affect our business and financial results.

•

we have incurred substantial debt, which could impair our flexibility and access to capital and adversely affect our financial position.

•

our ability to continue as a going concern depends on our ability to generate cash flows from operations and to conduct adequate financing activities. We expect we will require future additional capital.

•

our long-term success depends upon the successful development and commercialization of new products, particularly in the biosensor area.

•

significant interruptions in production at our principal manufacturing facilities and/or third-party manufacturing facilities would adversely affect our business and operating results.

•

our products may in the future be subject to product recalls that could harm our reputation, business and financial results.

•

the large amount of intangible assets and goodwill recorded on our balance sheet may lead to significant impairment charges in the future.

•

failure to achieve our financial and strategic objectives could have a material adverse impact on our business prospects.

•

changes in global economic conditions may have a material adverse impact on our results.

•

we are highly dependent on our senior management team and other key employees, and the loss of one or more of these employees or the inability to attract and retain qualified personnel as necessary could adversely affect our operations.

•

our revenues are highly dependent on a network of distributors worldwide.

•

our ability to protect our information systems and electronic transmissions of sensitive data from data corruption, cyber-based attacks, security breaches or privacy violations is critical to the success of our business.

•

our sales and operations are subject to the risks of fluctuations in currency exchange rates.

•

tax matters, including disagreements with taxing authorities, the changes in corporate tax rates and imposition of new taxes could impact our results of operations and financial condition.

•

the Covid-19 outbreak could significantly disrupt our operations and adversely affect our results of operations.

•

clinical trials necessary to support future premarket submissions will be expensive and will require enrolment of suitable patients who may be difficult to identify and recruit.

•

we may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or “off-label” uses.

•

if we fail to maintain regulatory approvals and clearances our ability to commercially distribute and market these products could suffer.

•

we face risks relating to our international sales and business operations, including regulatory risks, which could impact our current business operations and growth strategy.

•

we are subject to various laws targeting fraud and abuse in the healthcare industry.

•

we may be unable to protect or obtain proprietary rights that we utilize or intend to utilize.

•

our patent protection may not be sufficiently broad to compete effectively, the existing patents could be challenged; and trade secrets and confidential know-how could be obtained by competitors.

•

affiliates of Perceptive Credit Holdings III, LP (“Perceptive”) and MiCo IVD Holdings, LLC (“MiCo”) own approximately 19.0% and 23.6%, respectively, of the voting share capital of our Company (excluding ADS issuable with respect to warrants and a convertible note), which may give each of them significant influence over our management and affairs and may deter a change in control or other transaction that may be favorable to our shareholders.

•

our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our ADSs and penny stock trading.

•

as a foreign private issuer we are exempt from a number of reporting requirements under the Exchange Act and are permitted to file less information with the SEC than a domestic U.S. reporting company.

•

we may be classified as a passive foreign investment company,

•

the market price of our ADSs has been, and may continue to be, highly volatile.

•

we expect we will need additional capital in the future.

•

the conversion of our outstanding employee share options, any new employee share options and existing warrants would dilute the ownership interest of existing shareholders.

•

it could be difficult for U.S. holders of our ADSs to enforce any securities laws claims against us, our officers or directors in Irish Courts.

•

we have no plans to pay dividends on our ADSs, and you may not receive funds without selling the ADSs.

•

the terms of the deposit agreement limit the voting rights of holders of ADSs.

•

require us to use a substantial portion of our cash flow from operations to make debt service payments;

•

limit our ability to use our cash flow or obtain additional financing for working capital, capital expenditures, acquisitions or other general business purposes;

•

limit our flexibility to plan for, or react to, changes in our business and industry;

•

result in dilution to our existing shareholders in the event we issue equity to fund our debt obligations;

•

place us at a competitive disadvantage compared to our less leveraged competitors; and

•

increase our vulnerability to the impact of adverse economic and industry conditions.

•

incur, assume or guarantee additional indebtedness; or

•

repurchase capital stock;

•

make other restricted payments, including paying dividends and making investments;

•

create liens;

•

sell or otherwise dispose of assets, including capital stock of subsidiaries;

•

enter into agreements that restrict dividends from subsidiaries;

•

acquire another company or business or enter into mergers or consolidations;

•

The success of our research and product development efforts, in particular the significant development effort required to develop and commercialise the biosensor technology, including the glucose monitoring technology acquired in January 2024;

•

The time, cost and degree of success of conducting clinical trials and obtaining regulatory approvals;

•

The costs and timing of expansion of sales and marketing activities;

•

The timing and size of any repayment requirements for existing debt obligations;

•

The timing and success of the commercial launch of new products;

•

The extent to which we gain or expand market acceptance for existing, new or enhanced products;

•

The costs and timing of the expansion of our manufacturing capacity;

•

The magnitude of capital expenditures;

•

Changes in existing and potential relationships with distributors and other business partners;

•

The costs involved in obtaining and enforcing patents, proprietary rights and necessary licences;

•

The costs and liability associated with patent infringement or other types of litigation;

•

The costs related to, and the success of, our operational efficiency focused activities;

•

Competing technological and market developments; and

•

The scope and timing of strategic acquisitions.

•

The acquisition of the CGM assets and the related integration activities may require greater capital and other resources than originally anticipated at the time of acquisition;

•

The benefits expected to be derived from the acquisition of the CGM assets may not materialize and could be affected by numerous factors, such as the failure to complete planned research and development objectives, regulatory developments, general economic conditions and increased competition;

•

We may be unable to successfully integrate the CGM assets, products and technology into our business;

•

Worse than expected performance of the acquired assets may result in the impairment of intangible assets;

•

The acquisition will require substantial expense and management time and this could disrupt our business;

•

The biosensor industry, including the CGM industry, is a highly innovative area with several industry participants developing intellectual property portfolios over many years. As such there can be no assurance that the technology acquired from Waveform or further developed by us, will not infringe on other parties’ existing IP portfolios. We could incur significant costs and management time in defending against IP infringement claims.

•

We may not be able to accurately forecast the performance or ultimate impact of an acquired CGM business; and

•

The acquisition may result in the incurrence of unexpected expenses, the dilution of our earnings or our existing stockholders’ percentage ownership, or potential losses from undiscovered liabilities not covered by an indemnification from the seller(s) of the acquired business;

•

Suitable acquisitions or investments may not be found or consummated on terms or schedules that are satisfactory to us or consistent with our objectives;

•

The benefits expected to be derived from an acquisition may not materialize and could be affected by numerous factors, such as regulatory developments, insurance reimbursement, general economic conditions and increased competition;

•

We may be unable to successfully integrate an acquired company’s personnel, assets, management systems, products and/or technology into our business;

•

Worse than expected performance of an acquired business may result in the impairment of intangible assets;

•

Acquisitions may require substantial expense and management time and could disrupt our business;

•

We may not be able to accurately forecast the performance or ultimate impact of an acquired business;

•

An acquisition and subsequent integration activities may require greater capital and other resources than originally anticipated at the time of acquisition;

•

An acquisition may result in the incurrence of unexpected expenses, the dilution of our earnings or our existing stockholders’ percentage ownership, or potential losses from undiscovered liabilities not covered by an indemnification from the seller(s) of the acquired business;

•

An acquisition may result in the loss of our or the acquired company’s key personnel, customers, distributors or suppliers;

•

An acquisition of a foreign business may involve additional risks, including, but not limited to, foreign currency exposure, liability or restrictions under foreign laws or regulations, and our inability to successfully assimilate differences in foreign business practices or overcome language or cultural barriers; and

•

Our ability to integrate future acquisitions may be adversely affected by inexperience in dealing with new technologies.

•

Decreased demand for our products;

•

Lost revenues;

•

Damage to our image or reputation;

•

Costs related to litigation; and

•

Diversion of management time and attention;

•

contract manufacturers or suppliers may fail to comply with regulatory requirements or make errors in manufacturing that could negatively affect the efficacy or safety of our products or cause delays in shipments of our products;

•

we or our contract manufacturers and suppliers may not be able to respond to unanticipated changes in customer orders, and if orders do not match forecasts, we or our suppliers may have excess or inadequate inventory of materials and components;

•

we or our contract manufacturers and suppliers may be subject to price fluctuations due to a lack of long-term supply arrangements for key components;

•

we or our contract manufacturers and suppliers may lose access to critical services and components, resulting in an interruption in the manufacture, assembly and shipment of our systems;

•

we may experience delays in delivery by our contract manufacturers and suppliers due to changes in demand from us or their other customers;

•

fluctuations in demand for products that our contract manufacturers and suppliers manufacture for others may affect their ability or willingness to deliver components to us in a timely manner;

•

our suppliers or those of our contract manufacturer may wish to discontinue supplying components or services to us for risk management reasons;

•

we may not be able to find new or alternative components or reconfigure our system and manufacturing processes in a timely manner if the necessary components become unavailable; and

•

our contract manufacturers and suppliers may encounter financial hardships unrelated to our demand, which could inhibit their ability to fulfil our orders and meet our requirements.

•

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (2013);

•

ICH Harmonised Guidelines - Integrated Addendum to ICH E6 (R2) Guideline for Good Clinical Practice (Nov 2016);

•

ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice; and

•

ISO 14155:2020: Clinical investigation of medical devices for human subjects – Good clinical practice.

•

our inability to demonstrate to the FDA’s satisfaction that our products are safe and effective for their intended users;

•

insufficient data from our pre-clinical studies and clinical trials to support clearance or approval, where required; and

•

the failure of the manufacturing process or facilities we use to meet applicable requirements.

•

unanticipated expenditures to address or defend such actions;

•

customer notifications for repair, replacement and refunds;

•

recall, detention or seizure of our products;

•

operating restrictions or partial suspension or total shutdown of production;

•

refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;

•

operating restrictions;

•

withdrawing 510(k) clearances on PMA approvals that have already been granted;

•

refusal to grant export approval for our products; or

•

criminal prosecution.

•

the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and wilfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

•

the Physician Self-Referral Law, also known as the “Stark Law”, which provides for strict liability for referrals by physicians to entities with which they or their immediate family members have a financial arrangement for certain designated health services, including clinical laboratory services provided by our CLIA-certified laboratory owned and operated by our subsidiary Immco Diagnostics Inc., that are reimbursable by federal healthcare programs, unless an exception applies. Penalties for violating the Stark Law include denial of payment, civil monetary penalties of up to fifteen thousand dollars per claim submitted, and exclusion from federal health care programs, as well as a penalty of up to one-hundred thousand dollars for attempts to circumvent the law;

•

federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal third-party payers that are false or fraudulent. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “whistleblowers”, may share in any amounts paid by the entity to the government in fines or settlement. When an entity is determined to have violated the False Claims Act, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. Often, to avoid the threat of treble damages and penalties under the False Claims Act, which in 2020 were $11,665 to $23,331 per false claim, companies will resolve allegations in a settlement without admitting liability to avoid the potential treble damages. Any such settlement could materially affect our business, financial operations, and reputation;

•

the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

•

federal criminal laws that prohibit executing a scheme to defraud any federal healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

•

the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;

•

the federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the CMS, information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members and payments or other “transfers of value” to such physician owners. Manufacturers are required to submit reports to CMS by the 90th day of each calendar year. We cannot assure you that we have and will successfully report all transfers of value by us, and any failure to comply could result in significant fines and penalties. Failure to submit the required information may result in civil monetary penalties up to an aggregate of $150,000 per year (and up to an aggregate of $1 million per year for “knowing failures”) for all payments, transfers of value or ownership or investment interests not reported in an annual submission, and may result in liability under other federal laws or regulations;

•

federal and state laws governing the certification and licensing of clinical laboratories, including operational, personnel and quality requirements designed to ensure that testing services are accurate and timely, and federal and state laws governing the health and safety of clinical laboratory employees;

•

the U.S. Foreign Corrupt Practices Act, or the FCPA, which prohibits corporations and individuals from paying, offering to pay or authorising the payment of anything of value to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity; the UK Bribery Act, which prohibits both domestic and international bribery, as well as bribery across both public and private sectors; and bribery provisions contained in the German Criminal Code, which makes the corruption and corruptibility of physicians in private practice and other healthcare professionals a criminal offense; and

•

analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any payor, including commercial insurers; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

•

announcements of new products by us or others;

•

announcements by us of significant acquisitions, disposals, strategic partnerships, in-licensing,

•

joint ventures or capital commitments;

•

the developments of the businesses and projects of our various subsidiaries;

•

expiration or terminations of licences, research contracts or other collaboration agreements;

•

public concern as to the safety of the products we sell;

•

the volatility of market prices for shares of companies with whom we compete;

•

developments concerning intellectual property rights or regulatory approvals;

•

variations in our and our competitors’ results of operations;

•

changes in revenues, gross profits and earnings announced by us;

•

changes in estimates or recommendations by securities analysts, if the ADSs are covered by analysts;

•

fluctuations in the share price of our publicly traded subsidiaries;

•

changes in government regulations or patent decisions; and

•

general market conditions and other factors, including factors unrelated to our operating performance.

•

the debt is for a liquidated or defined sum;

•

the procedural rules of the U.S. Court must have been observed and the U.S. Court must have had jurisdiction in relation to the particular defendant according to Irish conflict of law rules (the submission to jurisdiction by the defendant would satisfy this rule); and

•

the judgment must be final and conclusive and the decree must be final and unalterable in the U.S. Court which pronounces it. A judgment can be final and conclusive even if it is subject to appeal or even if an appeal is pending. If the effect of lodging an appeal under the applicable law is to stay execution of the judgment, it is possible that, in the meantime, the judgment should not be actionable in Ireland. It remains to be determined whether final judgment given in default of appearance is final and conclusive.

•

if the judgment is not for a debt or a definite sum of money;

•

if the judgment was obtained or alleged to have been obtained by fraud;

•

if the process and decision of the U.S. Courts were contrary to natural or constitutional justice under the laws of Ireland and if the enforcement of the judgment in Ireland would be contrary to natural or constitutional justice;

•

if the judgment is contrary to Irish public policy or involves certain United States laws which will not be enforced in Ireland or constitute the enforcement of a judgment of a penal or taxation nature;

•

if jurisdiction cannot be obtained by the Irish Courts over the judgment debtors in the enforcement proceedings by personal service in Ireland or outside Ireland under Order 11 of the Irish Superior Courts Rules;

•

there is no practical benefit to the party in whose favor the foreign judgment is made in seeking to have that judgment enforced in Ireland, or

•

if the judgment is not consistent with a judgment of an Irish Court in respect of the same matter.

Item 4.

Information on the Company

A.	History and Development of the Company

•

Trinity Biotech Manufacturing Limited, based in Bray, Ireland;

•

Konamite Limited, based in Bray, Ireland;

•

Clark Laboratories Inc, based in Jamestown, New York;

•

Primus Corporation, based in Kansas City;

•

Biopool US Inc (trading as Trinity Biotech USA), based in Jamestown, New York;

•

Immco Diagnostics Inc, based in Buffalo, New York;

•

Trib Biosensors Inc, based in Wilsonville, Oregon;

•

Nova Century Scientific Inc, based in Burlington, Canada; and

•

Trinity Biotech Brazil based in Sao Paulo, Brazil.

Point-of-care		Clinical Laboratory
Infectious Diseases		Infectious Diseases		Haemoglobin		Autoimmune		Clinical Chemistry		Blood Bank Screening
UniGold		MarDx		Premier		ImmuBlot		EZ		Captia
Recombigen		FlexTrans		Ultra		ImmuGlo
Trinscreen						ImmuLisa
						OTOblot

•

Infectious diseases;

•

Glycated haemoglobin (for diabetes monitoring and diagnosis) and haemoglobin variants for the detection of haemoglobinopathies (haemoglobin abnormalities); and

•

Autoimmune diseases.

•

Sexually transmitted diseases, including Syphilis and Herpes;

•

Markers for Epstein Barr, Measles, Mumps, Toxoplasmosis, Cytomegalovirus, Rubella, Varicella and other viral pathogens, and

•

SARS-CoV-2.

•

Immunofluorescence Assay (“IFA”);

•

Enzyme-linked immunosorbent (“ELISA”);

•

Western Blot (“WB”); and

•

Line immunoassay (“LIA”).

 

•

Its clinical chemistry product range directly to hospitals and laboratories in Germany and France;

•

Infectious diseases and clinical chemistry product ranges directly to hospitals and laboratories in the UK; and

•

All product lines through independent distributors and strategic partners in a further approximately 100 countries.

		2023				2022				Total project costs to December 31, 20231
Product Name		US$’000				US$’000				US$’000
Premier Instruments for A1c and haemoglobinopathies testing			1,669				1,904				39,497

•

Immco entered into a licence agreement on January 19, 2012, and subsequently an amended licence agreement on June 14, 2018. The licence pertains to any product or service relating to identifying indicators of Sjogren’s disease. The agreement is effective through January 21, 2036 and is worldwide in scope. Royalties are payable based on agreement in place.

•

In 2013, we entered into a licence agreement with a leading market participant, giving us a non-exclusive, worldwide licence to access a significant HIV-2 patent portfolio for the purpose of making, using and selling a HIV test kit, subject to certain limitations.

•

On December 19, 1999, we obtained a non-exclusive commercial licence from the National Institutes of Health (“NIH”) in the United States for NIH patents relating to the general method of producing HIV-1 in cell culture and methods of serological detection of antibodies to HIV-1.

•

untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

•

unanticipated expenditures to address or defend such actions;

•

customer notifications for repair, replacement, refunds;

•

recall, detention or seizure of our products;

•

operating restrictions or partial suspension or total shutdown of production;

•

refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;

•

operating restrictions;

•

withdrawing 510(k) clearances or PMA approvals that have already been granted;

•

refusal to grant export approval for our products; or

•

criminal prosecution.

•

product design, development and manufacture;

•

product safety, testing, labelling and storage;

•

record keeping procedures;

•

product marketing, sales and distribution; and

•

post-marketing surveillance, complaint handling, medical device reporting, reporting of deaths, serious injuries or device malfunctions and repair or recall of products.

•

Are not to be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure; and

•

product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;

•

Quality System Regulation, (“QSR”), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;

•

labelling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;

•

clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices;

•

approval of product modifications that affect the safety or effectiveness of one of our approved devices;

•

medical device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur;

•

post-approval restrictions or conditions, including post-approval study commitments;

•

post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device;

•

the FDA's recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market a product that is in violation of governing laws and regulations;

•

regulations pertaining to voluntary recalls; and

•

notices of corrections or removals.