Immuron Limited - Case Study

Written: 28 September 2023

In this analysis, we are examining a pharmaceutical company that was heavily impacted by the COVID-19 pandemic despite having solid business fundamentals. The company's unique technology utilizes bovine colostrum (the first milk of cows after calving) combined with targeted oral polyclonal antibodies to produce treatments for gut diseases that traditionally rely on antibiotics. The company is currently selling two products - Travellan and Protectyn - while advancing four clinical programs to assess new applications for their technology. The company has also partnered with US government institutions for two of these trials and is receiving Department of Defence funding to assess applications of their Travellan Traveller's Diarrhoea product in the military, where such diseases are one of the top risks to soldier performance.

Analyzing companies whose share prices were heavily affected by COVID yet have maintained the potential of their business can be highly rewarding. In this case, the company entered this financial year with near-cash backing and rapidly recovering sales for its product.

Let's dive in and see whether Immuron (ASX:IMC) is a rare Triple Threat.

Threat 1: Spending to grow
Spending money wisely is a non-negotiable quality that all well-run companies possess. This is especially important for small growth companies where the business model is not yet established, and the funding runway is finite. In such cases, ensuring that each dollar is thoughtfully spent is important so that the company has the best chance of creating evolutionary value between dilutive capital raises.

In many of our past analyses, we often focused on non-cashflow-generating businesses, usually in the mining or biotechnology space. For Immuron, they have an interesting business structure where a revenue-generating business line (Travellan and Protectyn sales) exists alongside an extensive R&D program (four clinical trials).

This not only means they do not release quarterly cash flow reports but also means that their P&L statement items of interest exceed the usual R&D vs. G&A ratio. In this case, we are interested not only in the G&A cost relationship with R&D but also with gross profit. See the figures for the last four years below:
Period
Revenue
Gross Profit
General and admin expense
R&D expense
Full year FY2023
$1,804,705
$1,309,147
$4,220,905
$2,592,145
Half year ended 31 Dec 2022
$583,646
$427,920
$1,859,881
$1,521,635
Full year FY2022
$765,193
$523,502
$3,524,388
$657,715
Half year ended 31 Dec 2021
$230,964
$161,545
$1,688,014
$367,278
With these time periods in mind, let’s examine the ratios:
Period
Gross Profit : G&A
R&D : G&A
Full year FY2023
0.31
0.61
Full year FY2022
0.15
0.19
Half year ended 31 Dec 2022
0.23
0.82
Half year ended 31 Dec 2021
0.10
0.22
The figures here tell two stories. The first looks at gross profit, which shows that it is still far from sustaining G&A, unfortunately. Yet, if we examine the history of the company, COVID drove sales down to near zero and is only just starting to pick back up after licensing and logistics delays. Between FY22 and FY23, the ratio improved by 107%, which shows that gross profit can increase significantly without a meaningful increase in G&A. This means that the company can continue to increase sales to achieve a parity rate with G&A without concern for a linear increase in overhead costs.

The second story looks at R&D, which, similar to the gross profit dynamic, has increased meaningfully without a proportional increase in overhead G&A costs. This means that in recent years, the company has been able to run more growth investment activities (clinical trials in this case) on the same cost base as in previous years when less occurred.

Overall, we can see that Immuron has been able to increase gross profit and R&D, two key metrics (concurrently!), by 150% and 294%, respectively, despite just a 19.7% increase in general and admin costs.

If this continues, the company may rapidly be able to achieve breakeven and use potential profits (on top of already generous government cash grants) to fund blue-sky R&D programs where any success usually leads to a meaningful valuation re-rate for biotech and pharmaceutical companies.
About spending to grow
Threat 2: Setting goals
Investing is all about creating upside predictability in the investments we choose. This allows us to understand not only the risks in the investment, but also the likely payoff should management deliver on their roadmap.

Therefore, having management that is willing to commit to goals and follow through with their execution is very important. Yet, this is not to say that goals cannot be changed or replaced, as it's equally prudent to maintain an agile approach to business and ensure that things adapt.

A great way to examine for this “threat” is to review past milestones/goals and compare them to actual delivery. What we want to see is the timely completion of goals, or an acknowledged variable in them. What we do not want to see is goals changed or missed without any explanation.

In Immuron's case, the new managing director Steven Lydeamore has delivered a robust pipeline of goals across the company's four clinical programs. The investor presentation closest to him taking the role outlines this (link).
Let's review how many of these goals were satisfied within the time range given or varied with an updated explanation/guidance.

2H 2022
File IND for single dose IMM-124E per date ETEC challenge clinical trial
Filed and announced on 5 December 2022. Link
Submit complete response letter to FDA clinical hold for CampETEC clinical challenge study
Completed on 25 Jan 2023. Link
1H 2023
Initiate ETEC IMM-124E CHIM clinical trial
Recruitment started on May 30 2023. Link.
IMM-529 cGMP manufacture
Patent received on 17 Jan 2023 (Link), but manufacture delayed until 2H 2023.
Initiate USU P3TD IMM-124E field clinical trial
First participants enrolled on Jan 18 2023 (link)
2H 2023
Top line results for IMM-124E ETEC CHIM clinical trial
Disclosed on 7 June 2023 (link)
Initiate NMRC ETEC CampETEC CHIM clinical trial
Disclosed on 11 September 2023 (link)
Initiate NMRC CampETEC Campylobacter CHIM clinical trial
Disclosed on 7 June 2023 (link)
IMM-529 IND pre-IND submission
Disclosed on 7 June 2023 (link)
As we can see, the company has somewhat had success in meeting their timelines originally set out. A lot of this relates to the company's CampETC CHIM trial (targeting ETEC and Campylobacter) that was delayed as a result of an FDA hold, which was later resolved by at the expense of time. This is in addition to the highly unpredictable nature of most biotechnology and pharmaceutical development.

Yet in all cases of delay and variance, a timely update was provided informing shareholders of this change, in addition to an updated timeline. This is a great start as it wasn't simply ignored without commentary. What would be an improvement from here, is an explanation concerning the reason for the delay to provide additional transparency.

Overall, the company appears to have adhered to most of their timelines and we can therefore expect this to continue going forward. Immuron's latest timeline guidance is below.
About setting goals
Threat 3: Transparency
Investor transparency can take many forms but is important in ensuring that the market receives up-to-date information on all of the company's past and present activities. This goes hand in hand with setting goals.

In the case of high-risk companies, which constitute most of the small-cap section of the market, ensuring that investors understand all the good and bad aspects of the company is important. This commonly comes in the form of regular updates on the company's activities, as well as presentations to external groups.

Immuron has done a great job of maintaining regular communication with the market and ensuring that investors have complete information. Over the last four quarters, not only has the company advanced its underlying business, but it has also increased its release of presentations and provided more progress updates compared to 12 months prior.
Period
Progress Updates
Presentations
Q1 FY24
  • Immuron receives TGA GMP clearance (link)
  • Immuron achieves record monthly Travelan sales (link)
  • Immuron enrols patients in Travelan clinical study (link)
  • Immuron FY23 sales increase 136% on FY22 sales (link)
  • Immuron CEO, Steven Lydeamore to present at H.C. Wainwright (link)
  • Immuron present to Military Health System Research Symposium (link)
  • Immuron CEO, Steven Lydeamore to present at Bioshares (link)
Q4 FY23
  • Immuron initiates recruitment of Travelan clinical study (link)
  • FDA removed clinical hold on Campylobacter ETEC therapeutic (link)
  • Immuron Q3 sales reach 150% of 1H sales (link)
  • Immuron and US NMRC respond to CampETEC FDA clinical hold (link)
  • US DoD Travelan clinical recruitment milestone (link)
  • Immuron receives European patent on Drug composition (link)
  • Immuron CEO, Steven Lydeamore presents at LD Micro (link)
  • IMC CEO Steven Lydeamore to present at Coffee Microcaps (link)
  • Q3 FY23 Business Update Presentation (link)
Q3 FY23
  • Immuron receives FDA approval for Travelan IND application (link)
  • Immuron submits IND application to FDA for Travelan (link)
  • Immuron completes strategic investment in Ateria Health (link)
  • IMC investment in leading gut health Ateria Health (link)
  • Immuron executes Travelan clinical trial agreement pharmaron (link)
  • Business Update Presentation (link)
Q2 FY23
  • Immuron update on IMM-124E SARS-CoV-2 Research (link)
  • Update on IND application for Campylobacter ETEC therapeutic (link)
  • North American Travelan Sales up 494%, global sales up 431% (link)
  • European patent notification on drug composition for CDI (link)
This approach to transparency is especially important when the company encounters unexpected developments, such as the FDA hold on the CampETEC trial. These events may alter an investor's understanding of their investment risk profile, so ensuring that each step of the rectification process is communicated clearly is critical. In many cases, it is preferable to invest in companies that are transparent with risks and bad news, as this may show they have less to hide.

Indeed, the company has maintained a good cadence with investors via ASX announcements and has put meaningful effort into promoting to new groups through presentations. Additional opportunities lie in hosting more in-person events to better connect with investors, as well as facilitating more investor questions.
About transparency
My concluding thoughts

Immuron has had a patchy journey in the last 48 months. From COVID disrupting the sales of its travel medication products to the FDA delaying a clinical trial, the growth curve has not been straightforward. Yet, with the technology proven and products back on shelves, Immuron looks finally set to pick up where COVID left off by leveraging its $17 million cash balance and unique technology to drive high-margin sales. This is in addition to four clinical trials currently live, which provide additional upside on success.

However, there are a few areas of concern despite these positive signs. Firstly, the directors of the company have very little shareholding in the business, which could create misalignment with shareholder interests. Although this usually isn't an issue, it does place additional emphasis on the achievement of goals and remuneration discipline. Secondly, the company could further improve its communication strategy by facilitating more Q&A sessions and shareholder events.

Despite these two areas to note, Immuron has demonstrated a significant opportunity to generate shareholder value, and therefore, we view the company as a rare Triple Threat.

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