Trinity Biotech Announces Q1 2024 Financial Results and Reiterates Guidance
Trinity Biotech (Nasdaq: TRIB) reported its Q1 2024 financial results with several key highlights. The company posted total revenues of $14.7 million, a 0.8% decrease from Q1 2023. Point-of-Care (PoC) revenues surged by 39% quarter-on-quarter, driven by increased TrinScreen HIV sales, which contributed $1.2 million in Q1 2024. However, overall revenue from PoC products saw a decline of 17.2% compared to Q1 2023.
Net loss improved to $3.3 million from $5.5 million in Q4 2023. The company continues to expect annualized run-rate EBITDASO of $20 million on revenues of $75 million by Q2 2025. Operating efficiencies led to a 3.6 percentage point increase in gross margin, with further improvements anticipated. However, Trinity Biotech received a Nasdaq delisting notice due to not meeting the minimum market value requirement.
- Point-of-Care revenues increased by 39% Q/Q.
- Net loss reduced to $3.3 million from $5.5 million in Q4 2023.
- Gross margin improved by 3.6 percentage points.
- Guidance reiteration of $20 million EBITDASO on $75 million in revenue by Q2 2025.
- Successful rollout of TrinScreen HIV with $1.2 million in Q1 2024 sales.
- Significant progress in supply chain optimization and operational efficiency.
- SG&A expenses reduced to $7.5 million from $8.6 million in Q1 2023, a $1.1 million decrease.
- Total Q1 2024 revenues decreased by 0.8% compared to Q1 2023.
- Point-of-Care product revenue decline of 17.2% compared to Q1 2023.
- Clinical laboratory revenues dropped by 7.6% compared to Q1 2023.
- Received Nasdaq delisting notice for failing to meet minimum market value requirements.
- Net financial expenses increased due to higher outstanding loan balance.
- Operating loss of $3.0 million in Q1 2024, a reduction of $0.9 million from Q1 2023.
Trinity Biotech's Q1 2024 financial results provide several key insights for investors. The company reported total revenues of $14.7 million for Q1 2024, a slight decrease of
Despite a net loss of
The company has reiterated its guidance of achieving an annualized run-rate EBITDASO of
For retail investors, the key takeaway is that while there are current losses, the long-term growth prospects driven by the HIV PoC product and ongoing cost optimization appear promising. It’s also worth noting the substantial improvement in gross margins, which is important for profitability moving forward.
The development of Trinity Biotech's next generation Continuous Glucose Monitoring (CGM) system is an exciting prospect for investors interested in the health tech space. Engaging a leading design consultancy and applying for ethical approval for a pre-pivotal clinical trial demonstrate a solid pipeline strategy. The collaboration with PulseAI to leverage AI-driven health and wellness analytics further enhances the value proposition of their CGM system.
The company's focus on wearable biosensors aligns with the growing trend towards personalized healthcare. The ability to capture and analyze health data in real-time offers immense potential for better diabetes management. However, investors should be cautious as technological advancements often come with high R&D costs and regulatory hurdles.
The appointment of Avinash Kale as the CGM Programme Director could be a significant asset, bringing in expertise to drive these innovations. In summary, while the CGM developments are still in early stages, they have the potential to contribute significantly to the company's future growth and diversification.
Trinity Biotech's strategy to optimize its manufacturing and supply chain processes and offshore corporate services is expected to drive further efficiencies and cost savings. The successful rollout of the TrinScreen HIV test in Africa underscores the company's ability to penetrate emerging markets effectively.
However, the news of a potential delisting from Nasdaq due to non-compliance with market value requirements is a significant concern. It poses a risk to investor confidence and could impact the stock's liquidity. The company’s plan to request a hearing before a Nasdaq panel to seek an extension until November 2024 is a critical step to watch.
For retail investors, the key takeaway is to monitor how Trinity Biotech navigates these challenges while pursuing its growth and operational efficiency plans. The response to the Nasdaq compliance issue will be important in determining the company's market position and stock performance in the near term.
-Business performance on track to achieve approximately
-Strong sequential
-Disciplined execution of operational efficiencies led to 3.6 percentage point Q/Q increase in gross margin percentage with further improvements expected through 2024 and into early 2025-
DUBLIN, Ireland, May 23, 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 the Company’s results for the quarter ended March 31, 2024.
Existing Business - Key Highlights
Strong Quarter-on-Quarter Revenue and Profitability Improvements
- Strong demand and output in TrinScreen HIV drove a
10% quarter-on-quarter revenue increase with39% quarter on quarter revenue growth in Point-of-Care (“PoC”). - Continued disciplined execution on profitability enhancing initiatives contributed to:
- a decrease in the net loss from
$5.5m in Q4, 2023 to a net loss of$3.3m for Q1, 2024, a40% improvement, and - a
62% improvement on our EBITDASO position when compared to Q4, 2023.
- a decrease in the net loss from
- Based upon strong Q1, 2024 execution and continued momentum in the new management team’s Comprehensive Transformation Plan (see below), the Company expects further gross margin and EBITDASO improvement through 2024 and into early 2025.
- Company reiterates guidance of approximately
$20 million of Annualized run-rate EBITDASO1 on annualised run-rate revenues of approximately$75 million by Q2, 2025. This outlook is predicated solely on growth from the existing businesses including haemoglobin testing and HIV, and planned improvements to operating margins, with no contribution from the recently acquired biosensor business.
TrinScreen HIV Growth
39% quarter on quarter increase in revenue from our PoC portfolio driven by increased sales of our new TrinScreen HIV product.- Successful ramp up of TrinScreen HIV production in the quarter with sales of
$1.2m recognised in Q1, 2024. - TrinScreen HIV revenue was dilutive to our overall gross margin percentage in Q1, 2024, as we invested in training additional staff to support the ramp up in production. However, we do expect near term improvements in gross margin over the coming two quarters with additional automation coming online in Q2, 2024 through repurposing existing equipment and further supply chain optimisations. Additional improvements in profitability are expected later in the year as we move to offshore downstream assembly.
- Total orders of
$6m for TrinScreen HIV for 2024 supply received to date, with revenue of over$8m expected for fiscal year 2024.
Comprehensive Transformation Plan – Key Developments
- The following previously announced profitability initiatives are now contributing to improved financial performance:
- Our revised in-house manufacturing process of our key Diabetes HbA1c consumable.
- Reductions in headcount in late 2023 and Q1, 2024.
- Overall supply chain optimisation.
- Targeted price increases notified to customers in late 2023 and early 2024.
- We expect the above profitability initiatives to further contribute to improved financial performance improvements through 2024.
- In addition, we expect the launch of our improved diabetes column system, which is ongoing, to contribute to improved financial performance in 2024.
In early 2024, our new management team announced further profitability initiatives focused on delivering improved financial performance and since then the Company has made significant progress in advancing these key initiatives:
- Consolidate & Offshore Manufacturing:
- We completed training of our identified offshore manufacturing partner’s staff in the assembly of our rapid HIV tests.
- Significant progress in ceasing main manufacturing activities at our Kansas City manufacturing plant which currently serves our Haemoglobin business. We remain on track to have fully executed this change by the end of 2024.
- We completed training of our identified offshore manufacturing partner’s staff in the assembly of our rapid HIV tests.
- Optimise Supply Chain:
- We prioritised optimisation of our rapid HIV supply chain, with increased volumes from TrinScreen HIV creating opportunities to negotiate with supply partners, resulting in meaningful reductions in our cost of goods.
- We prioritised optimisation of our rapid HIV supply chain, with increased volumes from TrinScreen HIV creating opportunities to negotiate with supply partners, resulting in meaningful reductions in our cost of goods.
- Centralise & Offshore Corporate Services:
- We have substantially progressed the set-up of our centralised & offshored corporate services function. We have signed an implementation agreement with a third party outsourced partner.
Biosensor Developments
- We continue to progress the development of our next generation Continuous Glucose Monitoring (“CGM”) system in line with our previously communicated plan.
- We have now engaged a world leading physical & digital product design consultancy, based in London and California, to lead the design of this next generation solution.
- We are progressing technical optimisations of our glucose sensor wire.
- We have applied for ethical approval to begin a pre-pivotal clinical trial in June 2024. This pre-pivotal clinical trial will give us insights into the sensor optimisation pathway and we expect to receive ethical approval to commence the trial in the coming weeks.
- We also continue to focus on the exciting health & wellness analytical insight opportunities from our CGM’s data capture capabilities and recently announced a strategic collaboration with medical artificial intelligence company PulseAI. Under this collaboration Trinity Biotech will provide a unique pool of multi-parameter CGM datasets from Waveform’s existing biosensor database to PulseAI, which will be used to support the design and implementation of Trinity Biotech’s AI-driven health & wellness analytics platform.
- PulseAI are experts in evidence-based medical AI and have extensive experience in scaling AI algorithm training using medical sensor datasets. PulseAI have worked in association with Mayo Clinic to train their machine learning algorithms using large-scale datasets captured across millions of patients.
- We have also strengthened our team with the appointment of Avinash Kale as Continuous Glucose Monitor Programme Director. We are very excited to welcome Avinash to Trinity Biotech and believe Avinash will be instrumental in advancing our mission of introducing intelligent wearable biosensors, including CGMs, into markets all around the globe.
First Quarter Results (Unaudited)
Total revenues for Q1, 2024 were
2024 Quarter 1 | 2023 Quarter 1 | Increase/ (decrease) | |
US | US | % | |
Clinical laboratory | 11,712 | 12,669 | ( |
Point-of-care | 2,992 | 2,160 | |
Total | 14,704 | 14,829 | (0.8%) |
Our PoC portfolio generated revenues of
Our clinical laboratory revenues were
Gross profit for the quarter was
- the financial benefits resulting from our previously announced haemoglobins business initiatives, namely the optimisation of our instrument manufacturing supply chain and our revised in-house manufacturing process of our key diabetes HbA1c consumable, which we fully implemented by the end of Q1 2024, and
- a more favourable sales mix of higher margin haemoglobin consumables.
The improved margin performance in haemoglobins this quarter was offset by the margin impact of the higher TrinScreen HIV revenues, which are currently achieving a lower-than-average gross margin. Higher TrinScreen revenues will continue to dilute our overall gross margin percentage in the remaining quarters of 2024 given its lower price point when compared to our UniGold HIV test, but we do expect TrinScreen HIV to contribute additional gross profit as 2024 progresses due to further automation of our manufacturing process, increased operational efficiency and the expected transfer of assembly to a lower cost of manufacturing location by the end of 2024.
Additionally, over the coming quarters, we expect to realize further financial benefits of the previously announced cost saving initiatives in our haemoglobins, autoimmune and infectious diseases divisions.
R&D
Research and development expenses in Q1, 2024 were
SG&A
Selling, general and administrative (SG&A) expenses were
Key drivers of this lower SG&A expense include:
- Lower recurring salary and contractor costs of
$0.4m in Q1 2024 versus the comparative period, driven by headcount optimisation activities during Q3 and Q4 2023. - Cost savings of approximately
$0.6m due to the benefits of our other cost saving initiatives in the last twelve months. - Our share-based payments accounting charge was
$0.6m lower in Q1, 2024 compared to Q1, 2023, with the lower expense mainly due to the resignation of our former CEO in Q4, 2023.
A favourable movement in foreign exchange retranslation gains and losses, which shifted from an FX loss of$0.1m in Q1, 2023, to an FX gain of$0.1m for Q1, 2024, largely related to the accounting driven requirement to mark-to-market Euro-denominated lease liabilities for right-of-use assets. - These savings were offset by a quarter-on-quarter increase in operating expenses relating to our biosensor division of
$0.3m and higher amortisation of$0.3m mainly due to the Waveform acquisition which occurred during Q1, 2024.
Operating Loss
Operating loss for the quarter was
Net Financial Expenses
Net financial expenses in Q1, 2024 were
Additionally, the fair value movement of the derivative liability associated with warrants held by Perceptive resulted in a
Offsetting the above was an increase in the Amended Term Loan interest expense of
The financial expense for the current and comparative period are summarized in the table below.
Q1, 2024 US | Q1, 2023 US | |
Amended Term Loan interest | 2,560 | 2,119 |
Convertible note interest | 282 | 265 |
Notional interest on lease liabilities for Right-of-use assets | 147 | 167 |
Fair value movement on derivative balances | 841 | – |
IFRS modification adjustment to term loan | (3,566) | – |
264 | 2,551 |
Loss on continuing operations
Loss on continuing operations for the quarter was
EBITDASO
Loss before interest, tax, depreciation, amortisation, share option expense (Adjusted EBITDASO) for continuing operations for Q1, 2024 was
Q1, 2024 | Q1, 2023 | |
US | US | |
Loss on continuing operations | (3,317) | (6,305) |
Income tax expense/(credit) | 67 | (11) |
Net Financial Expense | 209 | 2,397 |
Depreciation | 164 | 351 |
Amortisation | 527 | 251 |
Adjusted EBITDA for continuing operations | (2,350) | (3,317) |
Share option expense | 812 | 1,364 |
Adjusted EBITDASO for continuing operations | (1,538) | (1,953) |
Loss per Share
The basic loss per ADS for Q1, 2024 was
Liquidity
The Group’s cash balance increased from
Excluding the recognition of a contingent liability of
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard
As previously reported in a Current Report on Form 6-K filed November 29, 2023, on November 21, 2023, the Company received a deficiency letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, for the preceding 30 consecutive business days, the market value of publicly held shares ("MVPHS") remained below the minimum
On May 22, 2024, the Company received a staff determination letter (the “Determination Letter”) from the Staff notifying the Company that it had not regained compliance with the MVPHS Requirement by May 20, 2024. Accordingly, and as described in the Determination Letter, unless the Company timely requests a hearing before a Hearings Panel (the “Panel”), the Company’s securities would be subject to suspension/delisting. Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. In that regard, pursuant to the Nasdaq Listing Rules, the Panel has the authority to grant an extension not to exceed November 18, 2024.
Notwithstanding the foregoing, there can be no assurance that the Panel will grant the Company an additional extension period or that the Company will ultimately regain compliance with all applicable requirements for continued listing on The Nasdaq Global Select Market.
Use of Non-IFRS Financial Measures
The attached summary unaudited financial statements were prepared in accordance with International Financial Reporting Standards (IFRS). To supplement the consolidated financial statements presented in accordance with IFRS, the Company presents non-IFRS presentations of, Adjusted EBITDA and Adjusted EBITDASO. The adjustments to the Company's IFRS results are made with the intent of providing both management and investors a more complete understanding of the Company's underlying operational results, trends, and performance. Non-IFRS financial measures mainly exclude, if and when applicable, the effect of share-based payments, depreciation, amortization and impairment charges.
Adjusted EBITDA for continuing operations and Adjusted EBITDASO for continuing operations are presented to evaluate the Company's financial and operating results on a consistent basis from period to period. The Company also believes that these measures, when viewed in combination with the Company's financial results prepared in accordance with IFRS, provides useful information to investors to evaluate ongoing operating results and trends. Adjusted EBITDA for continuing operations and Adjusted EBITDASO for continuing operations, however, should not be considered as an alternative to operating income or net income for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA for continuing operations and Adjusted EBITDASO for continuing operations are not measures of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. Reconciliation between the Company's operating profit/(loss) and Adjusted EBITDA for continuing operations and Adjusted EBITDASO for continuing operations are presented.
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 presentation 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 diabetes management solutions and human diagnostics, 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. 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. For further information, please see the Company's website: www.trinitybiotech.com
Trinity Biotech plc Consolidated Income Statements | ||
(US | Three Months Ended March 31, 2024 US (unaudited) | Three Months Ended March 31, 2023 US (unaudited) |
Revenues | 14,704 | 14,829 |
Cost of sales | (9,182) | (9,256) |
Gross profit | 5,522 | 5,573 |
Gross margin % | 37.6% | 37.6% |
Other operating income | 29 | – |
Research & development expenses | (1,089) | (860) |
Selling, general and administrative expenses | (7,503) | (8,632) |
Operating Loss | (3,041) | (3,919) |
Financial income | 55 | 154 |
Financial expenses | (264) | (2,551) |
Net financial expense | (209) | (2,397) |
Loss before tax | (3,250) | (6,316) |
Income tax (expense)/credit | (67) | 11 |
Loss for the period on continuing operations | (3,317) | (6,305) |
Profit for the period on discontinued operations | - | 496 |
Loss for the period (all attributable to owners of the parent) | (3,317) | (5,809) |
Loss per ADS (US cents) | (37.4) | (76.1) |
Diluted loss per ADS (US cents) | (37.4) | (76.1) |
Weighted average no. of ADSs used in computing basic earnings per ADS | 8,872,108 | 7,631,692 |
Weighted average no. of ADSs used in computing diluted earnings per ADS | 8,872,108 | 7,631,692 |
Trinity Biotech plc Consolidated Balance Sheets | ||
March 31, 2024 US$ ‘000 (unaudited) | December 31, 2023 US$ ‘000 | |
ASSETS | ||
Non-current assets | ||
Property, plant and equipment | 3,363 | 1,892 |
Goodwill and intangible assets | 38,572 | 16,270 |
Deferred tax assets | 2,020 | 1,975 |
Derivative financial asset | 232 | 178 |
Other assets | 79 | 79 |
Total non-current assets | 44,266 | 20,394 |
Current assets | ||
Inventories | 22,645 | 19,933 |
Trade and other receivables | 17,319 | 13,901 |
Income tax receivable | 299 | 1,516 |
Cash, cash equivalents and deposits | 5,776 | 3,691 |
Total current assets | 46,039 | 39,041 |
TOTAL ASSETS | 90,305 | 59,435 |
EQUITY AND LIABILITIES | ||
Equity attributable to the equity holders of the parent | ||
Share capital | 2,338 | 1,972 |
Share premium | 49,944 | 46,619 |
Treasury shares | (24,922) | (24,922) |
Accumulated deficit | (51,145) | (48,644) |
Translation reserve | (5,804) | (5,706) |
Equity component of convertible note | 6,709 | 6,709 |
Other reserves | 23 | 23 |
Total deficit | (22,857) | (23,949) |
Current liabilities | ||
Income tax payable | 337 | 279 |
Trade and other payables | 20,527 | 12,802 |
Exchangeable senior note payable | 210 | 210 |
Provisions | 50 | 50 |
Lease liabilities | 1,694 | 1,694 |
Total current liabilities | 22,818 | 15,035 |
Non-current liabilities | ||
Senior secured term loan | 58,674 | 40,109 |
Derivative financial liability | 1,367 | 526 |
Convertible note | 14,748 | 14,542 |
Lease liabilities | 10,310 | 10,872 |
Other payables | 1,760 | - |
Deferred tax liabilities | 3,485 | 2,300 |
Total non-current liabilities | 90,344 | 68,349 |
TOTAL LIABILITIES | 113,162 | 83,384 |
TOTAL EQUITY AND LIABILITIES | 90,305 | 59,435 |
Trinity Biotech plc Consolidated Statement of Cash Flows | ||
Three Months Ended March 31, 2024 US (unaudited) | Three Months Ended March 31, 2023 US (unaudited) | |
Cash flows from operating activities | ||
Loss for the period | (3,317) | (5,809) |
Adjustments to reconcile loss to cash used in operating activities: | ||
Depreciation | 164 | 351 |
Amortisation | 527 | 251 |
Income tax expense / (credit) | 67 | (11) |
Financial income | (55) | (154) |
Financial expense | 264 | 2,551 |
Share-based payments | 812 | 1,364 |
Foreign exchange gains on operating cash flows | (163) | (89) |
Other non-cash items | (153) | 195 |
Operating cash outflows before changes in working capital | (1,854) | (1,351) |
Net movement on working capital | (2,143) | (1,364) |
Cash used in operations before income taxes | (3,997) | (2,715) |
Income taxes received/(paid) | 1,178 | (3) |
Net cash used in operating activities | (2,819) | (2,718) |
Cash flows from investing activities | ||
Payments to acquire trades or businesses | (12,500) | - |
Payments to acquire intangible assets | (1,397) | (355) |
Payments to acquire financial assets | - | (700) |
Acquisition of property, plant and equipment | (66) | (274) |
Net cash used in investing activities | (13,963) | (1,329) |
Cash flows from financing activities | ||
Net proceeds from senior secured term loan | 21,676 | 4,853 |
Interest paid on senior secured term loan | (1,925) | (2,567) |
Interest paid on convertible note | (75) | (75) |
Interest paid on exchangeable notes | (4) | (4) |
Payment of lease liabilities | (556) | (599) |
Transaction costs paid in relation to the issue of share capital | (270) | - |
Net cash provided by financing activities | 18,846 | 1,608 |
Increase / (decrease) in cash and cash equivalents | 2,064 | (2,439) |
Effects of exchange rate movements on cash held | 21 | 14 |
Cash and cash equivalents at beginning of period | 3,691 | 6,578 |
Cash and cash equivalents at end of period | 5,776 | 4,153 |
The above financial statements have been prepared in accordance with the principles of International Financial Reporting Standards and the Company’s accounting policies but do not constitute an interim financial report as defined in IAS 34 (Interim Financial Reporting).
1 Earnings before interest, tax, depreciation, amortisation, share based payments from continuing operations– also excludes impairment charges and one-off items.
Contact: | Trinity Biotech plc | LifeSci Partners, LLC |
Des Fitzgerald | Eric Ribner | |
(353)-1-2769800 | (1)-646-751-4363 | |
E-mail: investorrelations@trinitybiotech.com |
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