Acelia Pharma reported its Q4 2024 earnings, focusing on its strategic advancements and financial stability. The company announced an operating loss of 21.9 million kronor, while maintaining a cash balance of 75 million kronor. According to InvestingPro data, the company’s financial health score is rated as GOOD, with particularly strong momentum and profit scores, despite operating with a significant debt burden of 2.6 billion USD. Acelia has extended its cash runway to late 2025, bolstered by a fully subscribed rights issue and potential additional financing. The company continues to advance its product pipeline, including the OrbiGlance and OncorAL projects, amidst a challenging market environment. InvestingPro analysis reveals the company is currently trading near its Fair Value, with a current ratio of 2.21 indicating reasonable short-term liquidity. Discover 6 more exclusive ProTips and comprehensive financial analysis with an InvestingPro subscription.
Key Takeaways
- Acelia extended its cash runway to late 2025.
- OrbiGlance NDA submission to FDA is planned for mid-2025.
- Phase 1 study for OncorAL completed; Phase 2 preparation underway.
- Acelia raised 105 million kronor through a rights issue in Q3 2024.
Company Performance
Acelia Pharma’s Q4 2024 performance was marked by strategic financial maneuvers and significant progress in its product pipeline. While the company reported an operating loss of 21.9 million kronor, its financial position shows resilience with an EBITDA of 509 million USD and a gross profit margin of 32.7% in the last twelve months. The company’s stock has shown positive momentum with a 9.5% return year-to-date, according to InvestingPro data. Access the complete Pro Research Report for deeper insights into Acelia’s financial health and growth prospects. The fully subscribed rights issue and potential financing from warrants highlight investor confidence in the company’s future prospects.
Financial Highlights
- Operating Loss: 21.9 million kronor
- Cash Balance: 75 million kronor as of December 2024
- Rights Issue: 105 million kronor raised in Q3 2024
Outlook & Guidance
Acelia plans to submit an NDA for OrbiGlance in mid-2025, with FDA pre-submission meeting conclusions expected in Q1 2025. The company is preparing for a potential US launch and exploring partnerships for commercialization. With analysts predicting profitability this year and the company maintaining a relatively low price volatility, investors seeking detailed analysis can access comprehensive valuation models and growth projections through InvestingPro’s exclusive research tools. Additionally, Acelia is developing a second-generation OrbiGlance effervescent tablet for lifecycle management.
Executive Commentary
"We are bringing to market a first-in-class diagnostic drug addressing an $800 million market for patients with a high unmet need," said Magnus Korvertsen, CEO of Acelia Pharma. Deputy CEO Julie Brogren emphasized, "Ninety percent of healthcare professionals are concerned with the issues related to gadolinium contrast agents," underscoring the demand for OrbiGlance.
Risks and Challenges
- Regulatory Risks: The success of OrbiGlance hinges on FDA approval.
- Market Competition: New entrants could challenge Acelia’s market share.
- Financial Sustainability: Continued losses could pressure cash reserves.
- Partnership Dependencies: Commercialization efforts rely on securing strategic partners.
Acelia Pharma’s Q4 2024 earnings call highlighted its commitment to innovation and financial prudence, setting the stage for future growth in a competitive market.
Full transcript - ACEA (BIT:ACE) Q4 2024:
Unnamed Speaker, Unspecified, Acelia Pharma: Welcome to Welcome to the conference.
Conference Moderator: For the first part of the conference call, the participants will be in listen only mode. During the questions and answer session, participants are able to ask questions by dialing 5 on their telephone keypad. Now I will hand the conference over to the speakers. Please go ahead.
Magnus Korvertsen, CEO, Acelia Pharma: Thank you, and welcome everyone to the webcast for Celliopharma’s Q4 Report for 2024. We will be making a number of forward looking statements on this call. On today’s call, we will start with recent key events and then head into our portfolio update before moving to financials and priorities ahead. After the presentation, we will open up for questions. I’m Magnus Korvertsen, CEO of Acelia Pharma.
And with me today, I have Julie Brogren, Deputy CEO. Andreas Nolan, our Chief Scientific Officer is unable to join us today, and he will join us at our next quarterly call. At the CEA Pharma, we identify, develop and commercialize novel drugs that address unmet medical needs within rare cancer conditions. We have two drugs in our pipeline. OrbiGlandse is in the registration phase as we have successfully completed the pivotal Phase three clinical study, SPARCL, and we’re preparing an NDA submission to the FDA.
Orwigland has orphan drug designation from the FDA and is targeting a global addressable market opportunity of $800,000,000 Oncrawl is ready to start Phase two in the treatment of gastric cancer based on encouraging results in Phase one and a high level of unmet medical need. Acilia is based in Malmo in Sweden and we are listed on NASDAQ Stockholm. The fourth quarter of twenty twenty four was busy with a lot of announcement that followed the successful outcome of the SPARC clinical study earlier in 2024. I’d like to briefly mention some of the key highlights. The interest in the scientific and medical community to learn about the SPACLE result has been significant and data was presented at the RSNA in December 2024.
We have also announced an additional five accepted abstracts here of three oral presentations at SAR, Society of Addominal Radiology, and at ESCAR, European Society of Gastrointestinal Radiology. We are proud of this high level of interest in oral glands. The full study report from the SPACLE study was also completed in Q4. And I was very pleased with the data, which reinforces the positive outcome of the study. In the fourth quarter, Mariana Koch was also elected to the Board of Directors of Acelia Pharma.
Mariana has a long experience from pharma, including global expertise in drug development, regulatory affairs and commercialization, and she is already adding significant value to Acelia. We are very excited about OrbiGlandse, and here’s why. OrbiGlandse is addressing a well defined unmet medical need for subgroup of people living with cancer. This is an $800,000,000 global market opportunity, and OrbiGlandse is a first in class product to target this and has often dropped designation from the FDA. We have strong data from nine clinical studies, and manufacturing has been upscaled to commercial scale.
With a strong Phase three data, OrbiGlandse has now been advanced to regulatory phase and we are preparing for an NDA submission. We’re pursuing some important value creation opportunities with OrbiGlandse. The first objective is a timely submission and approval of OrbitGlance with the optimal label. The key steps to achieving this is completion of the SPARCL clinical study report, which was done in early Q4. The next milestone is the conclusions from the pre submission interaction with the FDA in Q1.
And we are on track to deliver on this. Next (LON:NXT) milestone in line is the submission of the NDA to the FDA, which is in the middle of this year where we are also on track for delivering on that. The second objective is to progress OrbitGlance for commercialization. The key activities are continue to advance launch readiness by ensuring manufacturing and supply chain is ready for launch, as well as working with medical experts and key opinion leaders, payers, patient advocacy groups, and other key stakeholders. In addition to this, as we have announced, we’re pursuing a partnership for commercialization and we continue to make progress here as well.
I’m very happy with the progress we are making in the Silicon Valley and the efforts made by our team to ensure we will meet our objectives and create value for shareholders. We will now start the portfolio section of our presentation with OrbiGland and as Andreas is not here, I will continue. OrbiGland is a first in class liver MRI contrast agent, which addresses a very specific unmet medical need for which there are no good alternative today. Treatment of primary liver cancer and liver metastasis is an important challenge within oncology. Good visualization of cancer in the liver is critical for making the right treatment decisions.
Gadolinium based contrast agents are the gold standard procedure for examination of patients with suspected unknown tumors or metastasis as they improve the information from the imaging procedure. In patients with severe kidney impairment, use of gadolinium based contract agent has been associated with an increased risk of a very severe side effect called NSF, nephrogenic systemic fibrosis. This may have even fatal side effects. And, therefore, both the European and US regulatory authorities have issued warnings for the use of gadolinium based contrast agents in this group of patients. The consequence is that patients with impaired kidney function will often have an MRI without contrast, which will result in liver images of suboptimal quality with a risk for that, that the cancer is not managed in the best possible way.
Our ambition is to make Orwiglands, which is based on manganese, the product of choice for this patient population in need of liver imaging, where use of gadolinium may be medically inadvisable. The FDA has granted an orphan drug designation for organ gland for use in this population. In May, we share positive results from the SPARCL Phase three study. We found that organ gland enhanced liver MRI were superior to unenhanced MRI. As a quick reminder, I’d like to share the key highlights from the study.
The primary statistical evaluation compared visualization of focal liver lesions when reviewers had access to both the enhanced and unenhanced MRI images versus the unenhanced images alone. The primary endpoint is the mean pair differences. That means the difference on the same patient along with their 95% confidence intervals. And this is presented in the graph to the right. Notably, all mean pair differences are positive showing that the combined organ gland’s MRI is superior in visualizing focal ablation compared to unenhanced.
The analysis yielded a p value of less than 0.001 for both visualization variables across all readers. To further validate our findings, subgroup analysis were conducted and in every subgroup, combined MRI was preferred over unenhanced MR. The results from secondary endpoints consistently demonstrate superiority of orbitalance over unenhanced MR with no analysis favoring unenhanced MR. The safety analysis indicated that no serious adverse drug reactions were observed. More than eighty percent of reported reactions were mild and short lived, primarily related to the gastrointestinal tract, including nausea, diarrhea and vomiting.
The safety result from this vulnerable patient population were consistent with previous studies. With the completion of the SPARCL Phase three clinical studies, we have completed the clinical development. The comprehensive clinical program includes a total of two eighty six patients and healthy volunteers in nine clinical studies. Taken together, these studies have consistently demonstrated positive efficacy and safety of organelles. With the phase three study confirming the superior visualization of focal level lesions in the target population of patients with severe renal impairment and an adverse event profile consistent with what we were observed in the other studies, we are excited to move forward with the submission for marketing authorization to the FDA.
We are on track to submit the NDA for OrbiGlynce in the middle of this year. Having completed the full study report, we are now focusing on finalizing our pre NDA interaction with the FDA here in the first quarter. This step is crucial for finalizing our NDA submission to ensure alignment with the FDA to facilitate a smooth review process. In summary, the strong results from this vital study show that OrbiGland provides superior imaging compared to unenhanced MR and allows us to move forward towards market authorization. We’re excited about this opportunity to provide a better option for patients in need of liver imaging where use of gadolinium may be medically inadvisable.
Now, I’d like to hand over to Julie, to so she can talk about the commercial opportunity for Overgance.
Unnamed Speaker, Unspecified, Acelia Pharma: Thank you, Magnus. The addressable market for Overgland has a global value of $800,000,000 annually. The U. S. Represents almost half of this.
This market opportunity for ovaGlands addresses the unmet need for well defined patient population, cancer patients who need liver imaging and also have severely impaired kidney function. Our strategy for commercialization is to launch through partners. This strategy supports our ambition to secure the optimal balance between future revenues and the investment required. We have a focused ambitious launch strategy and plans built on advanced market insights in place and these will support this partnering strategy and the launch. As mentioned, The U.
S. Is the largest commercial opportunity for obliance. In The U. S. Alone, our real world data, I.
E. Data from realized procedures in our target patient population, show that every year, 100,000 abdominal imaging procedures are performed in around fifty thousand patients that fall under the black box warning for gadolinium contrast agents. So this is about four percent of people with cancer that undergo abdominal imaging. The well defined patient population with this clear unmet need also drives an attractive pricing opportunity. We’ve extensive input from market access and pricing experts with whom we’ve tested different price levels and collected insights on the evidence needed to support access and reimbursement.
And we have investigated pricing and access benchmarks of other innovative diagnostic drugs in The U. S. Ninety Percent of healthcare professionals are concerned with the issues related to gadolinium contrast agents. This includes the severe side effect associated with our target patient population, NSF. In fact, sixteen percent of providers have experienced cases of NSF in patients exposed to gadolinium.
These insights come from market research with two seventy US healthcare professionals and the answers from radiologists, nephrologists and oncologists. And the insights confirm the concerns with gadolinium in clinical practice and the unmet need for oblutants. Beyond the risk of NSF in kidney impaired patients, gadolinium is well known to be retained in the brain and other tissue in all patients. And the scrutiny over the possible safety effects is a key concern of regulatory and medical bodies. It’s also well known that gadolinium is excreted via the kidneys in urine.
Because it’s difficult to remove in our sewage system, it’s discharged into the environment and into our drinking water. There’s an urgency from regulators and medical bodies to find a viable alternative to the growing use of this toxic gadolinium, an alternative that is not associated with these potential safety and environmental concerns for patients and for the environment with gadolinium. So in short, the momentum for an alternative is getting better and better and the industry is responding. Recent developments from the large manufacturers of gadolinium are focused on smaller doses of gadolinium and there’s even an early stage injectable manganese contrast agent, which is not liver specific like Ovidlands. We are excited that we have a head start and that Overglance is expected to be a first in class to lead a future with less gadolinium and improved outcomes for patients.
The go to market strategy for Overglance is to launch with commercialization partners and our dialogue with such partners is progressing. This supports our objective to secure the optimal balance between future revenues and the investment required. This strategy also allows us to leverage the commercial capabilities already established by a partner. So our dialogue with these potential partners for the successful commercialization of Overland is progressing. We’re also working in parallel to ensure that Overglance and a partner is ready to launch upon FDA approval.
For example, that manufacturing is ready for the first product to be available in The US. We are very excited to see the successful acceptances of SPARQL data for presentation at major scientific conferences. Early October, we announced the acceptance of the primary results from SPARCL as an oral presentation in the cutting edge research at the annual conference of the Radiology Society of North America, the RSNA. This is the largest radiology conference globally. Later in October, we announced the acceptance of an abstract on SPARCL data as part of the late breaking science session at the American Society of Nephrology’s Kidney Week Congress.
Other key scientific conferences have subsequently also welcomed the presentation of SPARCL data. This includes the Society of Abdominal Radiology and the European Society of Gastrointestinal and Abdominal Radiology. In total, four oral presentations and three abstract presentations have been accepted at major conferences this far. This underscores the interest in all the glans within the medical and scientific community. I will now move to talk a little bit about OncorAL, the other asset in our development portfolio.
OncorAL is a daily tablet formulation of irinotecan, a well established intravenous chemotherapeutic agent. A daily tablet formulation enables a frequent low dose regimen that could offer advantages on both efficacy and on safety compared to the infrequent high dose intravenous administration used today. We have completed a phase one study which demonstrated a promising safety profile and an uptake of the drug after all dosing consistent with the daily dosing concept. We’re now ready for taking Oncrel into clinical phase two. The objective in phase two is to generate clinical proof of efficacy data in metastatic gastric cancer in combination with LUNSURF.
LUNSURF is another oral cancer treatment approved for gastric cancer. Animal data has demonstrated a synergistic effect of aveno chicken as IV formulation when combined with LUNSAFE. This makes this all oral combination very interesting. The planned Phase two study is designed to study Oncorale plus LUNSRF against LUNSRF alone. The study will randomize approximately 100 patients and involves a clinical collaboration with Taiho Oncology, the manufacturer of LUN SURF.
Taiho Oncology will provide clinical advice and supply of LUN SURF for the study. Irinotecan is a well established chemotherapy with recognized anti tumor effect in solid tumors. Our strategy is to start on corral development in gastric cancer, which is today a $3,000,000,000 market. For these patients, there’s a high unmet medical need for improving outcomes and there’s an opportunity for an orphan indication. We also see opportunities for developing Oncoral and other solid tumor indications, where a daily dosing tablet formulation can demonstrate an attractive efficacy and safety profile.
Immunotecan as an IV formulation is already approved in colorectal and pancreatic cancer. And in addition, it’s clinically demonstrated and recognized in guidelines for other cancer types. So we are assessing these opportunities as part of our ongoing strategic planning for Encore. I will now move to the update on our financials and priorities ahead. In Q4, our operating result was a loss, I.
E. Cost of 21,900,000.0 kronor. This is a slightly increased cost level compared to Q3 Q3 in 02/2004, driven by our cost for the NDA preparations. At the December 2024, we had 75,000,000 krona in the bank. With the fully subscribed rights issue of 105,000,000 Swedish kroner in Q3 twenty twenty four, we have a cash runway to late twenty twenty five, well beyond the NDA submission.
This cash runway excludes the repayment of the remaining 27,500,000.0 krona loans to Finnia, but it can be extended significantly with financing from partnering and from warrants. The proceeds from the issued TO1 series warrants alone can provide up to SEK70 million in April. To wrap up, we have substantial value creation opportunities ahead for Overglance and for Acilia Pharma. With Overglance, we’re bringing to market a first in class diagnostic drug addressing an $800,000,000 market for patients with a high unmet need. We have two key objectives.
One is a timely submission and approval of overglands with the optimal label. The key steps on the way are the completion of the SPARCL clinical study report, a milestone we achieved early November last year and which reinforced the successful study outcomes of the SPARCL Phase III study’s primary and secondary endpoints and which supports the NDA process. We are on track to share conclusions from a meeting with the FDA in Q1 twenty twenty five. And we plan to submit the NDA in the middle of this year. Our other objective is to progress Overglance for commercialization for patients in need by entering into a partnering agreement for the launch in The US and by securing that a partner and Overglance is ready for launch by approval.
All in all, the strong headline results from SPARQL mark the completion of clinical development for Overglance and reinforce our confidence in the regulatory and commercial path ahead for Overgland. We look very much forward to executing on these priorities ahead for Overgland and for a cellular farmer in 2025 and beyond. So this was the end of our presentation part, and we are ready to take your questions. So back to the moderator.
Conference Moderator: The next question comes from Ludwig Sveinsson from Carnegie. Please go ahead.
Ludwig Sveinsson, Analyst, Carnegie: Yes. Thank you very much for taking my question. So I just have one question for you today. Did you have your pre MDA meeting with the FDA yet?
Magnus Korvertsen, CEO, Acelia Pharma: So we will not talk specifically. What we’ll say is that we have the conclusion from the meeting in Q1 and we are on track for that. And as you know, there is a when you have the meeting, then you could say the final minutes from the meeting will be sent by the FDA no later than thirty days after the meeting has been helped. And that is the time when you can conclude on the outcome of the meeting. And we expect to communicate on the outcome of the meeting in Q1.
Ludwig Sveinsson, Analyst, Carnegie: All right. Great. Looking forward for that. Thank you very much.
Unnamed Speaker, Unspecified, Acelia Pharma: Yeah. Thanks. So do we. So do we. Yeah.
Conference Moderator: The next question comes from Johan Uneris from Redi. Please go ahead.
Johan Uneris, Analyst, Redi: Thank you for taking our questions. I have a few follow-up or clarification then. Just by the previous question, it seems like you are likely to be in this process given that it’s a thirty day period and you expect to receive the minutes done by the by Q1. So out of clarification then, when you receive the minute, that’s when this pre FDA process is completed?
Magnus Korvertsen, CEO, Acelia Pharma: Yes. So you could say you are right. So when we receive the minutes, then of course, we will carefully review them as quickly as absolutely possible and then be able to conclude if that has any implications on the plan that we already have in place or if there are any sort of edits that have a material impact. So what we will do is that we will do that, of course, as swiftly as possible and then we will share that information with everyone.
Johan Uneris, Analyst, Redi: Great. So, the minutes as such will not be published, but you will sort of publish the conclusion or the fact that you received them, of course, as well?
Magnus Korvertsen, CEO, Acelia Pharma: Yes. So, we will do like as everyone else. So, these minutes are, we would say highly confidential because it’s the, it would say confidential dialogue we have with the FDA. And I’m not aware of any companies that have ever shared that communication. So we will of course share the information in terms of what does it have any impact to the plan that we have.
We are very well on track for submitting in the middle of this year and, yes, we have the information and we’ve been listening to FDA feedback. So I think that is the scenario. So we are looking into this process and looking forward to receiving the minutes at some point and communicating the results.
Johan Uneris, Analyst, Redi: Excellent. And also, there is a potential that you will could benefit from a faster review process. And that decision and clarification, could that come then sometime after submission?
Magnus Korvertsen, CEO, Acelia Pharma: Yes. So the way it works for the prior to review is that at the time of submission, you ask for a prior to review by the FDA. And then the FDA will make a decision on whether they will grant it or not. And that’s how the process work.
Johan Uneris, Analyst, Redi: And time wise, presuming that you will sort of complete by mid submit by mid twenty twenty five? When could that clarification come sort of Yes.
Magnus Korvertsen, CEO, Acelia Pharma: So I don’t it’s probably somewhere on the FDA webpage in terms of how quickly they will respond. But it’s an initial part of the review process.
Unnamed Speaker, Unspecified, Acelia Pharma: It’s often as part of the comments you receive after around three months calendar time. But they have variations in when they respond to this, but that’s not uncommon.
Johan Uneris, Analyst, Redi: Yeah. We’ve seen that before that, well, there is some flexibility and and they they couldn’t respond faster sometimes and and and a bit later other times. Yes, another question, if you could share some dynamics on the partner conversations and also the related aspect of you being rather successful in sort of featuring your candidate at conferences, international conferences. Presumably, that’s an important arena to expand the network and AOLs and perhaps even add new partner conversations?
Unnamed Speaker, Unspecified, Acelia Pharma: Yes. I mean, this dialogue is ongoing and progressing. And so as you said, it’s really great to see that the results from SPARCL get interest in the medical and scientific community, of course, that also means something to a partner. So it’s all part of that kind of due diligence, you can say, both the clinical data from Phase three and the full study report and this recognition in the community, as you say, also by key opinion leaders and which includes the ones presenting our data and then, of course, FDA process and so forth. So it’s going it’s moving forward and, yes.
Johan Uneris, Analyst, Redi: Thank you. And finally, could you perhaps share something about the benefits and differences of Orbitglance two point zero, so to speak? You that’s subject in China, Asia, I suppose?
Unnamed Speaker, Unspecified, Acelia Pharma: Yes. So you’re referring to the granting of a patent in China for our second generation Overglance. And the second generation Overglance is an effervescent tablet formulation of also a manganese, so also oral agent for liver imaging. So in that sense, we see it really as a lifecycle management opportunity for the Overglance franchise. We think it’s an opportunity to sort of extend the total lifecycle of the asset.
And since there are markets such as Asian markets where you will always be required to have some local clinical data, perhaps it’s a good opportunity to combine that with the development of the second generation asset that there could be some synergies in that. So we, of course, expect that it’s as least as good as Overglance. That’s the indication we have so far.
Johan Uneris, Analyst, Redi: Interesting. And presumably, that would be sort of an investment decision that you would take once a partner is established?
Unnamed Speaker, Unspecified, Acelia Pharma: Yes. We think a partner would also be interested in clarifying what the roles are for this second generation asset, but also, of course, geographically and and so forth. So it’s part of those conversations, whether it’s drugs or drug proof fees that you put in the plans. Yeah.
Johan Uneris, Analyst, Redi: Excellent. That’s all from me. Thank you.
Magnus Korvertsen, CEO, Acelia Pharma: So we have some additional questions put in here. So one is a question relating to our announcement about an extraordinary general assembly in February instead of our regular annual general meeting in May. So the Board proposed this extraordinary general assembly to ensure as they write in the invite that there is a, you could say, an valuable incentive program to ensure, you could say, retention and motivation of all employees who are working on important milestones. And as is also described, the current value of all the combined incentive programs are expected to be maximum 400,000 matching shares, which is a very small world value. And that’s why they have decided to implement it now and make hopefully sure that there is no retention risk score and everybody is aligned on the objectives, which is also of great value to the shareholders.
So that’s why the implementation is down. It’s also very comparable to the previous option program that has been implemented, which expired end of last year. So there’s another question, whether we would have prefer either one or several partners, splitting geographies, etcetera. Julie, do you want to comment on that?
Unnamed Speaker, Unspecified, Acelia Pharma: Well, I think this is a high value, very focused launch for a small but well defined patient population. So there are a lot of synergies in the work around the medical community, the QPND leaders, and also the payers. So it it makes good sense for for to to focus around geographies. So I I think it makes good sense to have one fully dedicated partner to key geographies. So if someone wants to take more than The US, of course, that’s on the table.
It could also be that someone else is higher would would provide higher value for us if it’s another partner for for Europe and other geographies. So it could be more than one if we look at the global landscape. But within, a country, it there’s higher value for a partner and for us, likely if
Johan Uneris, Analyst, Redi: it’s only
Magnus Korvertsen, CEO, Acelia Pharma: one. There’s also a question here on whether we would sort of promote the Acelia sort of in a broader context, and I’m assuming that is related to investor communication and so forth. So we are having our quarterly calls. We’re participating in conferences and working through various, you could say, communication channels and and spending some good deal of time and and money on that. We’re always looking into how we can do this in the in the best possible way.
And and if any of you have some good ideas about how we could do that even more effectively, we are very I don’t see any more questions here in the feed. So if there are no further questions, thank you all for joining our Q4 twenty twenty four call. We’re very excited about the progress we made in 2024 and looking forward to continuing successful meeting the milestones here in 2025. Thank you and have a great day.
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