Q2 2023 Trinity Biotech PLC Earnings Call
Good day and welcome Trini Biotech, MOUNTS' second quarter financial results. All participants will be in the assembly mode. If you need assistance, please signal conference specialists by pressing the star key followed by zero.
After today's presentation are the opportunity to ask questions. Please note that this event is being recorded.
I'd like to turn the call over to Mr. Joe Diaz, of Latham Partners. Please go ahead.
Thank you, operator, and thanks all of you for joining us today to review the financial results of Pineda Biotech for the second quarter of 2023.
Joining us on today's call are Eric Caucasian, Chief Executive Officer, and John Gillard, Chief Financial Officer.
At the conclusion of today's prepared remarks, we will open the call for a question and answer session.
Before we begin, please note that statements made during this conference call may be deemed forward-looking statements within the meaning of federal securities laws.
These statements are subject to known and unknown risks and uncertainties that may cause actual events to differ from those expressed or implied in such statements.
These risks include, but are not limited to, those set forth in the risk factor statement in the company's annual report on Form 20F filed with the Securities and Exchange Commission. Attorney Biotech undertakes no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after today or the occurrence of unanticipated events.
With that said, I will now turn the call over to CEO Eris Kekajian for opening remarks. He will be followed by CFO John Gillard for review of the financial results, after which we will open the call for your questions.
Aris, the floor is yours.
Thank you. Good morning.
As usual, I will discuss the summary highlights for the quarter, and John Giller will discuss the detailed financial results.
In addition, we took the opportunity this quarter to take you through the in-depth details of our operational initiatives surrounding our core diabetes franchise. We think these are critical.
for our shareholders to understand as it's critical to our pivot.
and transformation.
Total revenue for fiscal Q2 2023 was $13.99. This excluded the Shell Industries which was disposed of in April 2023.
excluding our COVID-focused PCR vital transfer media, or VTM products.
Fitzgerald. Revenue for the quarter was 13.7 million which is comparable properly comparable given the changes.
This was 3 percent lower than in Q1, 2023.
Our core franchise diabetes consumables revenues increased 10% over Q1 2023.
This is a critical financial growth metric that is key to the transformation of the company.
Recurring diabetes consumers revenue rebounded strongly in Asia in the quarter.
increasing approximately 70% over Q1.
This was led by demand recovery in China.
Our expectation is that this level of demand will continue for the rest of 2023 in one of our most important markets.
In addition, diabetes revenues grew by over 10% collectively.
over the quarters in our direct distribution markets, namely the US and Brazil.
In other product lines, Clinical Chemistry, Chrome Systems, and Ciphalos product lines continue to show positive revenue momentum, despite key raw material backorders in some Clinical Chemistry product lines. I'll reflect on that as we continue the dialogue.
These revenues were gain... Sorry, these revenue gains were offset by lower infectious disease.
revenue compared to Q1 2023.
and reflects the irregular order cycle in this business line.
In addition, we phased out our non-core and difficult-to-scale transplant activity at our Buffalo, New York laboratory during the quarter.
Revenue outlook for Q3 is expected to be approximately $14 to $15 million.
Based on our current...
perspective on what we're seeing coming in and the fact that we've more or less closed the quarter.
we think that might be closer to the upper end of that range.
In addition, order back loss has increased substantially to Roxone 1 million, which is broadly double the run rate for the first half of 2023.
I want to give you a further perspective on the outlook for the rest of the year, especially around the hemoglobin franchise.
significant commercial reorganization, customer engagement initiatives and service quality improvements have positioned the core hemoglobin franchise for a strong second half.
2023 revenue performance.
We've made strategic instrument placements and focused on maximizing instrument utilization. These are gaining traction toward building an expanding recurring revenue profile for the business.
diabetes consumers are expected to increase over 20% in the second half of 2023 versus the first half.
In addition, diabetes instrument placements for the second half of the year are accelerating, are expected to be up double
to those placed in the first half.
Of 2023.
Now I'd like to turn our attention to some strategic highlights with respect to our key product lines.
First, on hemoglobin. In August , Trinity Biotech received USFDA 510K clearance for the Premier Resolution System.
the automated analyzer for accurate and precise quantifications of hemoglobin variants.
Our intention is to retake the market leadership position in human bone variance with this modern successor to the highly regarded Ultra-2 platform.
The premier resolution system builds on our ion exchange technology reputation of excellence.
and a market leading combination of accuracy, speed and value.
We expect this important clearance from the FDA to actually drive further penetration and increase utilization of the premier resolution system in key global markets.
including Brazil, where there's substantial scale in the blood screening market.
and allow us to begin the regulatory process.
to roll out the product in China.
The redevelopment of our flagship diabetes HbA1c platform, the PMER9210.
is on track for phase rollout in 2024.
The final redevelopment system is expected to feature improved backward compatible column and reagent formalization.
that should feature up to three times the current injection capacity, reduce calibration frequency, improve user interface, and better lab system integration.
The launch of the new columnar reagent will be the first step in a multi-generation product development plan aimed at expanding the target market into higher throughput segments.
driving a lower service downtime and cost while significantly expanding operating margins.
Our improved design combined with significant overhaul of our supply chain
are expected to yield significant reductions in the cost.
Costs of goods sold related to test volume, cost of service, and repair are all on the priority list.
These cost competitive actions are aimed at significantly expanding our total addressable market.
in a high-growth diabetes space.
We have initiated a program to manufacture a version of our core diabetes instrument in China, the 9210.
in addition to optimizing supply chain benefits. We believe this will enable us to double our reach.
in a very significant proportion of the Chinese hospital market that is limited to domestic manufacturers.
We plan to obtain regulatory approval for domestic market entry by late 2024.
Now, I'd like to take a moment to discuss our strategy to leverage and scale our reference lab in New York. This is the data Mustote chemistry toward Canada.
Efforts are at an advanced stage to significantly reposition scale the commercial focus of our 50 state certified lab in Buffalo, New York.
The company continues to see significant potential in its proprietary Sjogrens Brian Marker lab-developed tests.
Despite limited commercialization activities to date, we've had 20% average annual growth since 2020.
annual revenues are approaching 4 million. We think we can significantly scale this.
number.
a serious autoimmune complication of the broader dry eye market.
Studies indicate that Sjogren's syndrome may affect over 3 million individuals in the US, or about 1% of the population.
In conjunction with this opportunity, we are entering into a strategic revenue sharing partnership with trusted health advisors.
to lead our commercial and business development activities aimed at maximizing the children's opportunity.
The team comprising of ex-senior executives from Quest and Mayo Clinics brings decades of experience and extensive network in the industry.
We as partners intend to explore the opportunity to leverage the reference labs autoimmune capabilities.
to jointly expand beyond children's.
and look at proprietary biomarker library expansion opportunities.
This may give us the opportunity.
to develop this platform into a center of excellence for therapeutic drug monitoring and companion diagnostics.
across multiple autoimmune disease.
I'm very happy to have a team of this caliber working with us on such an important initiative.
Next.
I would like to update you on the status of our Trinscreen HIV launch in Kenya.
The company is focused.
on executing the launch and distribution of the Transgreen HIV
screening test. This follows the announcement by the Kenyon Ministry of Health last year of the adoption of this new HIV rapid testing algorithm.
This algorithm establishes Trinity Biotech's Trinscreen HIV as the standard screen test in Kenya under World Health Organization guidelines.
We have completed field evaluations of the algorithm in June .
The Ministry of Health has communicated procurement and use specifications to the agencies that are directly aimed at placing the orders.
and we have shift kits for training purposes.
We, along with the Kenyan government, are addressing legal challenges to the HIV testing algorithm and related process changes introduced.
We're anticipating resolution of the court challenges in hearings being held in early October .
Our expectation and the government's actions indicate that we will receive significant orders in the fourth quarter upon resolution of these legal maps.
The Canyon HIV Screening Program is one of the largest in Africa, with up to an estimated 10 million screening tests annually.
Now, I'd like to take a moment to discuss in a little bit more detail our operating initiatives. I thought it would be worthwhile sharing with you.
the status of the extensive operational transformation casual improvement activities
that have been underway for much of this year. We believe many of those activities are actually reaching an inflection point, and we'd like to share those with you now.
We are very focused on driving significant operational transformation and optimization to improve cash flow and allow our key products to gain cost competitive advantage in certain market segments.
As a company operates in a highly regulated healthcare sector, significant operational changes are typically subject to complex technical validation processes that can create time lag between initiation and change.
and final implementation.
In that context, many of the key operational and transformational programs we initiated over the past 12 or 24 months and are starting to deliver significant benefits.
and we project it to deliver increased and recurring cash flow benefits, while allowing us to target growth in certain lower-priced markets.
all the while maintaining target margins.
We'll let some of the key operational and transformational projects include the following.
First.
headcount optimization. This has been an ongoing effort, but in Q2 and Q3 2023 management accelerated headcount reductions as a result of process simplification initiatives that have been ongoing for the past several quarters.
The implementation of new software tools in quality and regulatory compliance.
as well as production planning.
and to reflect the lower than expected revenues.
particularly in light of the delays around the Kenyan HIV roll-up.
excluding the impact of the disposal to Cheryl's and limited hiring to support transcribing HIV manufacturing.
These changes are expected to deliver an approximately net 20% reduction in headcount by the end of Q4 2023, compared to Q1 2023.
with a resulting annualized cash flow savings of over $4 million.
Overall, this would represent an over 35% reduction in headcount compared to Q4 2020 when we originally started this optimization journal.
The majority of these 2023 reductions are in back office functions.
such as finance, quality, assurance regulatory, supply chain, etc. reflecting the impact of modernization and simplification projects led by senior functional leaders we have hired over the past couple of years.
We expect the financial benefit of the reductions to make a meaningful impact from Q4 2023.
To support Trinscreen HIV manufacturing, we have hired approximately 15 staff. I'd just like to reflect on a lot of these numbers I indicated to you.
We are highly focused on revenue per headcount as a key KPI for management, and we intend to continue to transform and optimize operations to improve this KPI over time. And we'll keep you posted on how we progress.
Beyond Headcount.
We are also focused on optimizing the entire hemoglobin's operation.
to enhance price competitiveness and profitability.
we see significant opportunity to truly refine this platform. Specific actions are as follows.
Number one.
With respect to our diabetes A1C consumables manufacturing optimization efforts.
We are now at the final stages of our revised manufacturing process for our key diabetes A1c testing column.
It's the key consumable for a 9210 instrument platform.
Bringing this process in-house in an optimized manner is projected to reduce the cost of goods sold of our diabetes A1c testing column by over 30%.
based upon current run rate production.
This is estimated to deliver over 1.5 million recurring annualized cash flow savings once we have fully transitioned to the revised manufacturing process and should allow our Premier 9210 A1C testing system to be more competitive and lower priced high volume segments of the market.
We expect the financial benefit of these reductions to make a meaningful impact in Q4 2023.
with an increased savings of the level of 2024 as we transition completely away from the legacy manufacturing process.
Initiative number two with respect to our core hemoglobin platform.
Diabetes A1c instrument supply chain optimization.
over the past 12 months.
We have initiated a supply chain optimization program for this instrument.
with the intent of reducing cost and optimizing the quality of the instrument by moving to a more competitive supply chain.
environment.
This program has progressed significantly.
We have already commenced securing materials savings of 20% per instrument.
Given the success of this program today, we are now targeting savings of 40 to 50 percent in material costs for our PREMIER 92 instrument, which is based upon our expected production run rate and would deliver, based on that run rate, annualized cash flow savings of 1.5 million until completed.
These changes are already delivering a working capital benefit in terms of low inventory costs.
and expected EBITDA impact to begin in late 2023 or earlier 2024.
As inventories can work in so far.
In addition,
This lower cost of production should allow us to competitively target growth in segments
diabetes A1C testing market that are lower priced but much higher volume than our traditional focus segments.
This would allow us to significantly scale our business in terms of revenue while maintaining target margins.
There is also significant component commonality between our PREMIER 9210 and our Hemoglobin Variant Instrument, the PREMIER resolution that recently received FDA clearance.
This means that many of the stages in C for the 92 instrument can also carry into meaningful lower cost production for the Premier Resolution.
The third key initiative I like to highlight with respect to this platform.
is the fact that we are rebuilding and repositioning the diabetes A1c reagent column system core to our 9210 instrument.
As previously discussed, we are developing an improved backward compatible reagent call-up system.
Please.
system is expected to feature up to three times the injection capacity of our current system.
This program is at its final stages of development and technical validation.
Subject to this validation.
We expect to launch this new reagent column in early 2024 and estimate that this system should deliver recurring annualized incremental cost of goods sold cash flow savings of over 1 million.
while again facilitating us, more importantly, to competitively target growth in segments of the A1C testing market at our lower price but much higher volume.
that are traditional focus segments.
the ability for us to maintain volumes.
because our reagent business is much higher margin than our insurance business. This is a razor blade model and high volume is a critical way to scale.
We are applying the same thinking now.
with all of this discussion about our
Hemoglobin's business.
to our HIV product manufacturing as well.
We have initiated a program to optimize the location and cost of certain downstream manufacturing and supply chain activities related to our HIV products, namely Unigold and Trinscreen.
Our initial assessment indicates that such a program could well deliver several million dollars of annual cash flow savings while providing the company with additional manufacturing capacity to meet the increased and expected demand for Trinspring as we roll the product out in additional countries.
We expect this key product...
this key project to start to deliver recurring savings in 2024 and we will provide further updates on this program as it progresses.
over the next couple of quarters.
These initiatives have combined to increase.
these initiatives have contributed to some increased sGNA expenditure over the last 12 months.
we will continue to require some further investment over the coming quarters.
Management believes that the future profitability and growth of the company is significantly dependent on optimizing our cost structure and cost competitiveness which makes these investments key to delivering significant returns over the medium term.
We are prioritizing investing.
in the delivery of recurring savings or recurring revenue.
as they should deliver an increased sustainable EBITDA and thus increase capital value in each of our core business areas.
Before I turn it over to John , I'd like to address.
ongoing balance sheet optimization, and the development of new growth opportunities.
As can be seen from the results from the past three quarters, our SG&A has increased. A major driver of this increase is expenditure on third-party market research.
technical assessment consultancy services, and other related costs as we seek to identify next generation biotech opportunities.
for the very significant growth market segments within our total addressable market.
We are trying to position Trinity and its capabilities where the TAM is significant or larger especially as it relates to adjacencies.
around our diabetes franchise.
As a result of this work, we have now identified and are pursuing a select number of investment areas.
and associated targets.
In conjunction with pursuing these targets, we're also closely working with our existing lenders, Perceptive Advisors,
to both improve the terms of our existing financing.
considering our lower debt levels.
and to gain their support and investments in these high growth opportunity areas.
These discussions are going well.
We continue our strategic review of some of our non-core business lines for potential capital reallocation to lower debt or
reallocate capital to high growth opportunities.
Our approach to improving cash flow through operational transformation and organic growth in our core business areas should also play a key role in providing cash flow for investment availability to incrementally improve financing.
With that, I would like now to turn it over to John Gillard.
We will provide you a more detailed review of the financial results for the quarter. Following that, we will take your questions.
Thank you.
Thank you, Iris. Good morning, everyone. Now I will take you to the results for the second quarter of 2023. As you may be aware, we sold our Fitzgerald Industries business in April this year.
So in our income statement for Q223, the results of FASTERA have been reported separately within discontinued operations.
As was the case in our Q1 earnings, the revenue, gross, profit and operating loss numbers are stated without its germs for both Q2 2023 and the comparative period.
Starting with revenues, total revenues for the quarter were 13.9 million compared with 15.4 million in Q2 2022.
Gross margin for the quarter was 36.2%, which is the same as for Q2 2022.
Here we are seeing that sales price increases and cost saving issues that we have implemented in the last year have been offset by lower revenues over a significantly fixed and semi-fixed cost base.
and buy unfavorable sales mix changes.
In particular, the loss of the transplant testing services at our Buffalo Lab has had a negative gross margin impact.
As I will speak to you later, and as Iris has already discussed, we are taking significant action to address our cost base.
R&D expenditure increased from 1 million to Q2 2022 to 1.2 million in Q2 2023, mainly due to lower capitalization of payroll costs.
into the product development of intangible assets.
as key products came to the end of their development cycle.
Meanwhile, SG&A expense in the quarter increased by 2 million compared to Q2 2022, mainly due to the effect of three different cost increases.
Firstly, $0.9 million of the increase was due to higher share-based payment expenses.
This is a non-cash accounting charge relating to performance share based compensation awards.
which are intended to closely align the goals of our team with those of our shareholders in the creation of shareholder value.
Secondly, there was an increase of $0.6 million due to external technical advisory, legal and professional fees.
The board of the company is committed to our corporate development and corporate finance activities.
as we continue to assess strategic opportunities for inorganic growth and balance sheet optimization.
In particular, we are seeking to identify next generation biotech opportunities for very significant growth in market segments with total addressable markets of real scale that can fuel Trinity Biotech's growth into a much larger scale company.
As such, we have invested in market research, technical advisory, and other professional services to assist us in successfully mapping our way to these key areas.
Thirdly, within SG&A, there was an FX loss of 26K for Q2 2023 compared to an FX gain of 0.6 million in Q2 2022, resulting in an unfavorable variance of approximately 0.6 million.
This mainly relates to lease liabilities for our rented premises.
We have recorded an impairment charge of 10.8 million to score compared to an impairment charge of 0.5 in Q2 2022.
The impairment test performed as of June 30, 2023 identified an impairment loss in two cash-generating units, namely IMCO Diagnostics and Trinity Biotech Brazil, with the majority of the impairment charge relating to IMCO.
InCo's laboratory has for a number of years provided transplants, excuse me, testing services to a local healthcare provider.
However, in early 2023, that healthcare provider informed the company that it was moving to a different service provider, and this resulted in lost revenues for the laboratory since the beginning of Q2 2023.
Secondly, the expected level of additional laboratory services.
revenue arising from a partnership that I'm aware of has not materialized.
As a result, ImCo's value in use has fallen below the carrying amount of its relevant assets.
Similarly, Trinity Biotech's Brazil value in use at the end of June is below the value launch date, or at least it wouldn't hit the stadium with Freeze's
Included within the IMCO impairment is a full impairment of the financial assets associated with the company's 1.5 million investment in IMOware.
To date, the company has paid 700,000 of this 1.5 million investment, I'm aware, but as the investment agreement provides for total potential investment of 1.5 million, this amount has recognised their balance sheet in Q1 2023.
Given the uncertainty over the future of IMRware's performance and thus the value of this investment, management have decided to impair the entire 1.5 million of committed investment.
We have not today paid the additional $800,000 to IMAWARE, which remains in our balance sheet as an accrued pay-about.
However, we have contested whether we have a valid obligation to pay the additional age of 1,000 and expect discussions on that matter to continue with IMOware.
The aforementioned items have resulted in an operating loss for Q2 2023 of 14.9 million compared to an operating loss of 1.9 million reported in Q2 2022.
Moving on to net financial expenses of $3.8 million in Q2 2023 compared to $8.3 million for Q2 2022.
The decrease of 4.5 million is mainly due to the comparative period including a penalty for early settlement of the Senior Secure Term Loan, or Perceptive, in Q2 2022 of 3.5 million, whereas in Q2 2023 there was an early repayment penalty of 0.9 million.
Additionally, early partial settlements of the term loan result in an acceleration of the accretion interest expense under the applicable IFRS accounting provisions.
This accelerated interest expense was $2.1 million in Q2 2022 and $0.5 million in Q2 2023.
These variances account for $4.2 million of the decrease, while the remaining decreases account for by decreases in the fair value of derivatives of $0.4 million and an increase of $0.1 million, convertible note interest, as the note was issued midway through the comparison period.
Although our borrowings are now significantly smaller following our repayments of debt, the interest cash expense is broadly similar to the comparative period last year as our main borrowing accrues interest at a significantly higher interest rate than during Q2 2022 due to base interest increases in the interim.
The profit on discontinued operations was 12.4 million in Q2 2023, comprising a gain on disposal of Fitzgerald Industries of 12.7 million, offset by trading loss of 0.3 million for discontinued operations.
The gain on disposal was made up of proceeds of approximately 30 million offset by associated transaction costs of 1.3 million and the net assets are limited on disposal of 16 million.
The trading loss of approximately 300,000 mainly comprises the results of Fitzgerald on 1 April to the date of sale on 27 April 2023.
In Q2 2023 the loss per ADS is 16 cents compared to 29 cent loss per ADS in Q2 2022.
I will now move on to address some of the main balance sheet movements we have seen since quarter one 2023.
PPE decreased by 3.6 million in Q2. Of this, 3.5 million relates to the impairment charge for IMCO.
Intangible assets decreased by 5.6 million with 5.8 million relating to impairment of in-cause intangible assets.
The remainder is made up of amortization of 0.2 million offset by acid additions of 0.4
The majority of the additions to intangibles relate to product development in our hemoglobin business, and some of this expenditure contributed to us gaining FDA 510K clearance of our primary resolution instruments in August .
As I mentioned above, financial assets have decreased by 1.5 million as a result of our impairment of the investment in Imaware.
The senior secured term loan liability has decreased by $9.4 million during the quarter as we repaid $10.1 million of the senior secured debt held by perceptive advisors from the proceeds of the Fitzgerald thing.
The remaining movement is made up of accretion interest.
Finally, to briefly mention our cash flow for the quarter, our cash balance increased by 10 million in Q2 2023, from 4.2 million at the end of Q1 to 14.2 million at the end of Q2.
including the cash balance of the stern and the Q1 number of 4.2 million, although you will note that this balance was reported on March balance sheets within asset 10% rather than in cash balance.
Now turning to the operational transformation issues as we outlined in today's press release and as discussed by Aris
As I said out of previous earnings calls.
driving recurring operational cost savings has been a key priority for Trinity over the last few years and indeed since I've joined.
and has been a major driver in us hiring some of the senior function leaders that have joined the business over the past three years.
As Ira said out, and as you will note from today's press release, in Q2 and Q3 management initiated a significant headcount reduction program.
As a result of this program, net of limited hiring for Trinscreen production, we expect a headcount reduction of approximately 20% by the end of 2023, compared to our headcount in Q1 2023, with an expected annualised saving of 4 minutes.
We expect that the financial benefits of these reductions will really start in Q4 2023 and will reach full run rate savings in early 2024.
We've also focused on reducing the cost of our core products through manufacturing and supply chain optimizations.
including the four million of cost of goods saving expected in our diabetes business, from the key three initiatives being moving a key manufacturing aspect of our main diabetes test consumable, our column, in-house, changing the sourcing of key components of our Premier 92 and Premier Resolution instruments, and the launch of a new diabetes column and reagent system.
All of these, as I said, are expected to deliver a combined 4 million annualized run rate savings.
These initiatives should lead to a significant improvement of the operating margin and cash flow generation profile of our hemoglobin business.
The savings are now starting to come through, but we expect it will be mid to late 2024 until we see the full 4 million impact of those savings.
We're also focused on improving the cost of our HIV tests, Unigold and Trinscreen. As Aire set out, we've identified opportunities to change some downstream manufacturing activities, which we believe could save several millions of dollars per year and allow us effectively to scale production to meet the increased demands as we roll out Trinscreen HIV to new Americans.
This is a very exciting opportunity and we expect it will deliver savings from late 2024 and is now a key priority for the operations team.
We are focused on delivering recurring annual savings.
that in turn increase the sustainable EBITDA of our businesses.
This in turn should increase the capital value of these businesses and ultimately our shareholders' equity.
simple rule of thumb.
if we assume a 10x EBITD evaluation of multiple.
which is broadly what we saw with Fitzgerald.
Each 1 million of annualized sustainable savings is worth 10 million in capital value.
In addition...
if these savings can also allow our products to become more cost competitive and deliver growth through accessing new market segments.
That then delivers an additional benefit to shareholders.
Finally, we are in advanced discussions with our current lenders perceptive regarding an update to our existing credit facility and we expect to access improved interest rates.
recognizing our progress in lowering debt compared to when we initially took over the debt.
plus access to additional capital to fund the key strategic investments in next generation biotechnology areas.
I expect we'll have further updates on that for shareholders in the short term.
With that, I will hand it back to Aris. Thank you.
Thank you, John . Appreciate the thorough update. I think you can all appreciate that.
We endeavored in this call to be a bit more in depth.
and specific about our initiatives and efforts. As John mentioned, some of these things take time. We are in a regulated industry.
but we felt both the combination of
positive momentum.
from a commercial standpoint and improvements that have been implemented over the last 24 months.
From a COGS standpoint, we believe we're actually approaching an inflection point. Now, we don't want to get ahead of ourselves, but we do feel very confident about the progress we're making, and we wanted to share that with you.
With that said, we'd like to.
Hand it over to questions.
Thank you. Now begin the question and answer session. Ask a question, you may press star then one on your touch tone phone.
If you're using a speakerphone, please pick up your handset before pressing the keys.
To withdraw your question, please press star then 2. This time we'll pause momentarily to assemble the roster.
The first question is from Jim Sidoti of Sidoti & Company. Please go ahead.
Hi, good morning. I'll have to go over this morning, but let's start with the business that you lost in in Buffalo.
transplant services testing business. So on an annual basis, how material is that for you?
Hi, Jim. It's Prop John here. It's probably about two million in revenue. We had seen some declines in it.
It's not huge material, you know
It was a difficult business to scale.
So, you know, the vast majority of our business at that lab is focused on autoimmune disease, in particular our proprietary showbiz test.
You know the transplant business required kind of 24-7, 365 staffing And so there was some additional costs associated with that I'm not saying we were happy to to lose that business but it was not core to us and Did add complexity as we set out the press release was not easy to scale Because inherently the transplant business you have to be within a certain geographical distance typically to where the
Where the transplant activity is happening, so you know you're limited. Yeah in a geographic
I think you have to be within 30 miles typically so you're basically covering two hospitals. You can't scale.
And as John mentioned, the standby requirements and frankly.
We everementally parachute.
Had a chance to try to win that business or maintain that business. We actually bid it pretty low
But we felt at some level it didn't make any sense anymore because long term we couldn't scale it.
And so at the level it went at, I think we felt confident we had better opportunities, to be honest with you.
If you look at the margins in Sjogren's compared to the margins in Transpond, they're not even close.
And we have a chance here to partner with a team that people know what they're doing to really scale the showrooms business So you know what, that's the right focus right now.
Okay, all right. And you did give guidance for the third quarter, which is higher than the second quarter, despite the fact you bought this business. Should we take that as saying maybe the second quarter is a... I know you don't want to give long-term guidance, but you think this second quarter was a low watermark for you and that you'll see revenues from your other businesses continue to grow to offset this business and some of the other...
COVID type businesses so that revenue should sequentially be climbing for the next several quarters.
Again, I think your premise here is actually.
pretty much why John and I wanted to spend the time on this call.
baseline people, okay. We feel like we bottomed on all of the changes we had to make on the revenue run rate. We feel confident about our sequential.
revenue profile going forward.
at an inflection point. That's our view.
Okay, and now if we switch over to the premier business, it was down overall in the quarter, but that was, sounds like that was all on instruments that the consumer business continues to grow. Is that correct? Yeah, look, the thing you got to look at in this core business, in the premier business, and eventually as we get into rolling out the resolution product in a more extensive way is really about consumables. That's where all the money is, right? We generate, again, apologies, I'm not trying to get you all very accurate here. But sometimes all of the things that we produce for consumers sing is free trial. That doesn't mean that it costs a lot to the consumer, but for the Baltimore generation Standard currently,
greater than 50% margins in the consumer rolls.
It's recurring revenue. The instruments are there to largely drive that consumable revenue profile.
So we've been focused very much on being strategic about where we're placing instruments, making sure that, and I can tell you John's a stickler for this, making sure that we've got recurring revenue profiles associated with those instrument placements around the world so that the payback makes sense. And that is a big change in terms of how we've been running the place historically versus we are today. Okay, so this is where...
The french eyes skills
And this is our number one focus.
And Jim, just to augment that, as we reduce down the cost of us manufacturing the instrument,
Right, that will allow us to be more competitive in terms of placing instruments.
which would ultimately allow us to have a greater footprint, which again will drive revenue in the consumables, right? So really reducing down the cost of the instrument is reducing down a barrier to market entry in certain segments.
And coupled with that is we can reduce down the cost of goods of our consumables, in particular our column, will allow us to be cost competitive while also maintaining margin. So there's a comprehensive strategy here to grow. We've had some market research done on the A1C testing business. And that feedback indicates that cost is critical and that kind of validates the path we've been on for.
for the last 12, 18, 24 months and trying to get these cost reductions through. As Darius' point, we're in a regulated market. This is not stuff you can just flick the switch on. But the flip side of that is once you've made those changes, those regulatory barriers that slowed you down can become somewhat of a competitive moat around your business.
Okay, and that's actually where I was going to ask that next, the regulatory.
hurdles. Now you've overcome a big one I think when you got resolution improved but it's a separate 510K for the new column and then for the 9210? No. Well let's put it this way. The changes we're anticipating at the end of the year into 2024 don't require any significant regulatory approval.
They've been undergoing validations.
testing which are required but we don't need any regulatory approval.
Are there regulatory approvals planned in the updates later in 24 and 25? Yes.
But for the initial launch of these improvements, the things John's talking about, the 3x improvement in call and performance, etc., that's all within the purview of what we've got going on right now.
And look, one of the other things I think I want to expand on.
with respect to John's point.
Competitiveness is a huge factor here in scaling the volume and volume is the game but the other thing you got to keep in mind is
if we can actually increase throughput of our system, which is what we're working on with the caller.
we start getting to higher volume segments in general.
It's not just price driven, but it's the fact that we can actually draw it into higher volume segments.
So we're trying to scale this thing by driving costs down.
driving through put ups.
That's how you make money in this business. It's not very complicated.
Okay, and so you don't need any – you can launch the new column then when you're ready. And then I do – I would assume you would need some kind of 510K for the 9210 in 2024.
Well, we're looking at next generation changes, which would.
significantly potentially increase the volume.
the number of tests per column. So like I said, John , we've been talking to you about increasing the column test numbers right now by 3x in the current generation. We feel confident that's all within our purview. We are looking at strategies to increase that even more, potentially to double that. That would probably require regulatory approval, and that's why we are concurrently, in addition to the changes we're about to roll out in the fourth quarter, concurrently working on that longer term process. And we think that'll be late 24 before we get.
All right. And then can you just give us some kind of sense on what the legal challenges are left in Kenya? Are you confident that you'll have this resolved?
in 2023 and that you'll be able to start shipping units by the end of the year.
Look, I'm not going to, I'm not going to apply on legal matters necessarily, but I will say
When you look at...
the actions being undertaken by the government.
and the progress being made.
In our assessment of the situation, we believe that the
that these matters should be resolved in early October . There are a couple of hearings coming up.
And in principle, our view is those hearings should all rule in the favor of the government ourselves and should be able to move forward. Okay.
I am not, unfortunately, I'm not going to give you a prediction on that other than to say we're confident that we feel
that these matters should be resolved and that we will move forward at least with the expectation that the government has and ourselves, our expectation in terms of all the activities that we are moving forward.
And then lastly, you ended the quarter with about $14 million in cash. Do you think that's sufficient? I know you expect cash flow to improve over the next few quarters as some of your initiatives start to take effect. Do you think the cash flow is sufficient? I just want to be clear. I don't think it's sufficient. And John and I are working with our lenders to make sure we have plenty of liquidity going forward.