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Trinity Biotech Announces Increased Orders for TrinScreen HIV and Raises Guidance For 2024 Sales

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Trinity Biotech plc (Nasdaq: TRIB) has announced increased orders for its TrinScreen HIV product, leading to an upward revision of its 2024 sales guidance. The company now expects TrinScreen HIV sales to reach approximately $10 million in 2024, up from the previous estimate of $8 million. This increase is attributed to strong demand and successful scaling of production capacity.

Additionally, Trinity Biotech has increased manufacturing capacity for FlexTrans™, its FDA 510(k) cleared viral transport medium, in anticipation of potential increased demand due to the WHO's declaration of Mpox as a Public Health Emergency of International Concern. The company aims to contribute to diagnostic testing for this global health threat.

Trinity Biotech plc (Nasdaq: TRIB) ha annunciato un aumento degli ordini per il suo prodotto TrinScreen HIV, portando a una revisione al rialzo delle aspettative di vendita per il 2024. L'azienda prevede ora che le vendite di TrinScreen HIV raggiungano circa 10 milioni di dollari nel 2024, rispetto alla precedente stima di 8 milioni. Questo incremento è attribuito a una forte domanda e a un riuscito ampliamento della capacità produttiva.

Inoltre, Trinity Biotech ha aumentato la capacità produttiva per FlexTrans™, il suo mezzo di trasporto virale approvato dalla FDA 510(k), in previsione di una possibile maggiore domanda a causa della dichiarazione dell'OMS riguardante l'Mpox come Emergenza Sanitaria Pubblica di Rilevanza Internazionale. L'azienda mira a contribuire ai test diagnostici per questa minaccia sanitaria globale.

Trinity Biotech plc (Nasdaq: TRIB) ha anunciado un aumento en los pedidos de su producto TrinScreen HIV, lo que ha llevado a una revisión al alza de su pronóstico de ventas para 2024. La compañía espera ahora que las ventas de TrinScreen HIV alcancen aproximadamente 10 millones de dólares en 2024, por encima de la estimación anterior de 8 millones. Este incremento se atribuye a una fuerte demanda y a una exitosa ampliación de la capacidad de producción.

Adicionalmente, Trinity Biotech ha aumentado la capacidad de fabricación de FlexTrans™, su medio de transporte viral aprobado por la FDA 510(k), anticipando una posible mayor demanda debido a la declaración de la OMS sobre Mpox como Emergencia de Salud Pública de Preocupación Internacional. La compañía busca contribuir a las pruebas diagnósticas para esta amenaza de salud global.

트리니티 바이오텍 plc (Nasdaq: TRIB)는 TrinScreen HIV 제품에 대한 주문 증가를 발표했으며, 이로 인해 2024년 매출 전망을 상향 조정했습니다. 회사는 이제 2024년 TrinScreen HIV 매출이 약 1천만 달러에 이를 것으로 예상하고 있으며, 이는 이전 추정치인 800만 달러에서 상승한 것입니다. 이 증가분은 강한 수요와 생산 능력의 성공적인 확장에 기인합니다.

또한, 트리니티 바이오텍은 FlexTrans™의 제조 용량을 늘렸습니다. 이 제품은 FDA 510(k) 승인을 받은 바이러스 운반 매개체로, WHO가 Mpox를 국제적 건강 비상사태로 선언함에 따라 잠재적 수요 증가를 예상하고 있습니다. 회사는 이 글로벌 건강 위협에 대한 진단 테스트에 기여하는 것을 목표로 하고 있습니다.

Trinity Biotech plc (Nasdaq: TRIB) a annoncé une augmentation des commandes pour son produit TrinScreen HIV, ce qui a conduit à une révision à la hausse de ses prévisions de ventes pour 2024. L'entreprise s'attend désormais à ce que les ventes de TrinScreen HIV atteignent environ 10 millions de dollars en 2024, contre une estimation précédente de 8 millions. Cette augmentation est attribuée à une forte demande et à une augmentation réussie de la capacité de production.

De plus, Trinity Biotech a augmenté sa capacité de fabrication pour FlexTrans™, son milieu de transport viral approuvé par la FDA 510(k), en prévision d'une demande potentiellement accrue en raison de la déclaration de l'OMS concernant Mpox en tant qu'urgence de santé publique d'importance internationale. L'entreprise vise à contribuer aux tests de diagnostic pour cette menace mondiale pour la santé.

Die Trinity Biotech plc (Nasdaq: TRIB) hat einen Anstieg der Bestellungen für ihr Produkt TrinScreen HIV bekannt gegeben, was zu einer Anhebung der Umsatzprognose für 2024 geführt hat. Das Unternehmen erwartet nun, dass die Umsätze mit TrinScreen HIV im Jahr 2024 etwa 10 Millionen Dollar erreichen, was über der vorherigen Schätzung von 8 Millionen Dollar liegt. Dieser Anstieg wird auf eine starke Nachfrage und eine erfolgreiche Erweiterung der Produktionskapazität zurückgeführt.

Darüber hinaus hat Trinity Biotech die Herstellungsfähigkeit von FlexTrans™ erhöht, dessen FDA 510(k) genehmigtes virales Transportmedium in Erwartung einer möglichen erhöhten Nachfrage aufgrund der Erklärung der WHO, dass Mpox eine Notlage der öffentlichen Gesundheit mit internationaler Bedeutung ist, angepasst wurde. Das Unternehmen zielt darauf ab, einen Beitrag zur diagnostischen Prüfung dieser globalen Gesundheitsbedrohung zu leisten.

Positive
  • Increased orders for TrinScreen HIV product
  • Upward revision of 2024 sales guidance for TrinScreen HIV from $8 million to $10 million
  • Successful scaling of production capacity to meet demand
  • Increased manufacturing capacity for FlexTrans™ viral transport medium
Negative
  • None.

Insights

The increased orders for TrinScreen HIV and subsequent revenue guidance raise are significant developments for Trinity Biotech. The projected $10 million in sales for 2024, up from $8 million, represents a 25% increase in expected revenue from this product line. This substantial growth suggests strong market acceptance and demand for TrinScreen HIV, potentially indicating improved market penetration or expanded distribution channels.

Moreover, the company's ability to scale up manufacturing capacity to meet this increased demand is a positive indicator of operational efficiency. This scalability could be important for future growth and ability to respond to market opportunities. The mention of increased capacity for FlexTrans™, their FDA-cleared viral transport medium, in response to the WHO's PHEIC declaration for Mpox, demonstrates the company's agility in addressing emerging health threats. This positions Trinity Biotech favorably in the rapidly evolving infectious disease diagnostics market.

The upward revision of TrinScreen HIV sales guidance is a positive financial indicator for Trinity Biotech. The additional $2 million in expected revenue represents a meaningful increase for a company of Trinity's size. This could potentially improve profit margins if the increased production doesn't lead to proportional cost increases.

Investors should note that while this news is encouraging, it's important to consider how significant TrinScreen HIV sales are in relation to Trinity's overall revenue. The company's diversification into multiple product lines, including diabetes management solutions and wearable biosensors, provides some buffer against market fluctuations in any single product line. The potential for increased FlexTrans™ sales due to the Mpox PHEIC could further boost revenues, though the exact impact remains uncertain. Overall, this news suggests improved near-term financial prospects for Trinity Biotech, but a comprehensive analysis of the company's full product portfolio and market position would be necessary for a complete financial outlook.

The increased demand for TrinScreen HIV reflects positively on both Trinity Biotech and the broader HIV diagnostics market. This surge in orders could indicate expanding HIV testing initiatives in key markets, potentially driven by public health campaigns or increased healthcare funding. The company's long history in rapid HIV testing gives it a strong foundation to capitalize on this growth.

The mention of potential increased demand for FlexTrans™ due to the Mpox PHEIC is also noteworthy. While the direct impact is yet to be seen, it highlights Trinity's ability to leverage its existing product lines to address emerging health crises. This adaptability could be a key differentiator in the competitive diagnostics market. However, investors should be cautious about overestimating the impact of Mpox-related sales, as the scope and duration of this demand are uncertain. Trinity's proactive approach to scaling production for both TrinScreen HIV and FlexTrans™ suggests a responsive strategy to market dynamics, which could position them well for future opportunities in infectious disease diagnostics.

DUBLIN, Ireland, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced that it has received substantial additional orders for TrinScreen HIV. As a result of this strong demand and the successful scaling of production capacity, the Company is now increasing its expected 2024 sales revenue for TrinScreen HIV to approximately $10 million, up from $8 million previously.

John Gillard, President and Chief Executive Officer of Trinity Biotech, said, “Trinity has had a long history of supplying its rapid HIV tests to markets with the greatest need, and we are pleased to have scaled up our manufacturing capacity to meet the increased demand for TrinScreen HIV.  Also, as a company with a strong presence in infectious disease, we have also increased our manufacturing capacity for our U.S. Food and Drug Administration (FDA) 510(k) cleared viral transport medium, FlexTrans, in anticipation of potential increased customer demand due to the recently declared World Health Organization (WHO) Public Health Emergency of International Concern (PHEIC) for Mpox. We will continue to look for opportunities to contribute to diagnostic testing for this global health threat.”

Forward-Looking Statements

This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe-harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterised by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on our purchase of the assets of Waveform, our continued listing on the Nasdaq Stock Market, our ability to  achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2023 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.

About Trinity Biotech

Trinity Biotech is a commercial stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors.  The Company 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 and has recently entered the wearable biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. Our 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 and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please see the Company's website: www.trinitybiotech.com.

Contact:Trinity Biotech plcLifeSci Partners, LLC
 Micheal RocheEric Ribner 
 (353)-1-2769800(1)-646-751-4363
  investorrelations@trinitybiotech.com
   
  RedChip Companies Inc.
  Dave Gentry, CEO
  (1)-407-644-4256
  TRIB@redchip.com

FAQ

What is Trinity Biotech's new sales guidance for TrinScreen HIV in 2024?

Trinity Biotech has increased its expected 2024 sales revenue for TrinScreen HIV to approximately $10 million, up from the previous estimate of $8 million.

Why has Trinity Biotech (TRIB) increased its manufacturing capacity for FlexTrans™?

Trinity Biotech has increased manufacturing capacity for FlexTrans™, its FDA 510(k) cleared viral transport medium, in anticipation of potential increased demand due to the WHO's declaration of Mpox as a Public Health Emergency of International Concern.

What factors contributed to Trinity Biotech's increased sales guidance for TrinScreen HIV?

The increased sales guidance for TrinScreen HIV is attributed to substantial additional orders received and the successful scaling of production capacity to meet strong demand.

How is Trinity Biotech (TRIB) responding to the Mpox global health threat?

Trinity Biotech is increasing its manufacturing capacity for FlexTrans™, its viral transport medium, to potentially contribute to diagnostic testing for Mpox in response to the WHO's declaration of it as a global health threat.

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