Thank you for joining the H.C. Wainwright 28th Annual Global Investment Conference. My name is Joshua Korsen, and I am a senior equity research associate. Today, I would like to introduce our presenter, Robert Andrade, who is the CFO of Fennec Pharmaceuticals. The floor is yours.
Thank you, Josh, and thank you to H.C. Wainwright for having us here. This is maybe going on 10 years for us, so much appreciated. I see some new faces and some existing faces that have been interested in the story. This is our safe harbor statement. We are a publicly traded company, so I encourage you to read our SEC filings accordingly. Going a little bit into Fennec.
We have one product. It is PEDMARK, and it is the first and only FDA-approved therapy for the prevention of cisplatin-induced ototoxicity or hearing loss. Importantly, it is the only FDA-approved product for any form of prevention of hearing loss. We were approved in September of 2022, and thereafter, we received NCCN Category 2A endorsement for the prevention of CIO, or cisplatin-induced ototoxicity, for the AYA population or that population from ages 15 to 39.
We are a global company. We announced a partnership with Norgine in 2023 as it relates to Europe, Australia, and New Zealand. We also recently announced some Japanese preliminary results as we embark to look for a partner for both registration and for commercialization in Japan.
We have a partnership in the Middle East and in Turkey with Inpharmus. Bottom line, anywhere where you see cisplatin administration, and we will get into some of the uses here in subsequent slides, we would hope that you would utilize PEDMARK for the prevention of that hearing loss.
We have a long-term value proposition here for investors with a robust IP portfolio with patents extending until 2039. We did settle a patent infringement lawsuit with a generic until 1 September of 2033. In Europe specifically, we are under PUMA or Paediatric-use marketing authorisation, which gives us 10 years of exclusivity.
Importantly, about two years ago, we reshaped and refocused Fennec. Our CEO is here in the audience. His name is Jeff Hackman. He brought under him a new and seasoned commercial leadership team to focus and sharpen our focus commercially and medically. You will see it not only in their expertise and their experience, but also in our results, which we will share coming up.
This was done by our marketing team, which I think is ingenious. You see here survival with an asterisk. Why with the asterisk? Because cisplatin is incredibly effective, up to 90% long-term survival across various tumor types, but there is an asterisk. That asterisk is hearing loss. That is something that we address in PEDMARK.
Cisplatin, if you are not familiar with it, is a cornerstone in cancer care. It has been around for nearly half of a century, but it comes with the price of hearing loss. Across all ages, recent studies showed that about 75% of patients that are administered cisplatin have some form of hearing loss.
Here is cisplatin in itself and its uses. Pediatric, you can see across various tumor types, neuroblastoma, medulloblastoma, and in the AYA population for which we have NCCN Category 2A endorsement, some of the significant cancer types with some of the more prevalent uses being testicular cancer, cervical and uterine, and head and neck cancer.
Importantly, though, there is significant survivorship, nearly upwards of 87% across tumor types. That comes with a cost. As I mentioned, approximately 60%-90% of patients treated with cisplatin develop some form of hearing loss.
It can be accompanied by tinnitus. Effectively what happens is the cisplatin enters your ear, and it causes an oxidative stress, eliminating these tiny hair cells that all of us have, whether you are a one-month-old baby or you are in your later years of life. Up to 40% of patients that are administered cisplatin would require some form of hearing aids. If not hearing aids, then cochlear ear implants. If not that, then living with the lifelong burden.
Damage can start early. What is the goal of our team here is to start the use of PEDMARK prophylactically with cisplatin, so from day one. Generally, cisplatin can be given anywhere from 6x to 15x . With each dose of cisplatin, six hours later, the goal would be to dose PEDMARK to prevent that hearing loss.
It is an unseen burden. Many people say there is high survivorship. That is the truth, but that is just the tip of the iceberg. It can come with ringing in the ears, the obvious hearing loss, decreased sound tolerance, which then impacts your entire life, your quality of life. Social settings, isolation, stress, anxiety, depression, economic hardship can come with hearing loss.
Hearing loss, I think all of us have been around somebody that has their hearing impacted, can impact the way patients live, learn, connect, their family members, how they react socially. Our goal here is as you go into taking cisplatin, you do not know which patient will have that hearing loss, which patient will be impacted. The goal would be a safe, effective, and tolerable drug, and PEDMARK is utilized.
There was no way to prevent ototoxicity until we received approval in September 2022. The alternatives I have discussed earlier, but were hearing aids, cochlear ear implants, some personal frequency modulation, speech rehabilitation. Ultimately, once you lose your hearing, you cannot get it back.
There has been some studies done in terms of the overall economic burden. I personally think this underestimates it if you just think economically. Studies range anywhere from $500,000 to 1 million in terms of the overall burden on an individual from the loss of hearing, including loss of productivity, educational costs, and medical costs. Until now.
We are almost on our fourth year anniversary here for the approval of PEDMARK. PEDMARK was studied for over 30 years, including two phase III trials, one of which was published in the New England Journal of Medicine, which proved that that prevalence of hearing loss was cut by at least in half.
That's the vial of PEDMARK that you would receive. The vial is based on two factors, or the amount of vials. One is the amount of cisplatin infusions, and the second part is the size of the patient. Many things I've said here before. The bottom line is this is the only approved therapy for the prevention of ototoxicity associated with cisplatin, this being PEDMARK.
PEDMARK has a 15-minute infusion time given six hours post the cisplatin and a unique formulation. Importantly, after approval, we received NCCN, which is the gold standard 2A endorsement for the adolescent and young adult population, otherwise defined as that age group from 15 to 39.
E ffectively, we received approval for pediatric patients, which you would traditionally think under the 18 years of age, and then we received 2A endorsement for that population. That then expanded it up to 39.
Importantly, all patients of all ages that receive cisplatin are impacted with that hearing loss. A little bit about the two markets. In the pediatric population, you can see here approximately 2,000 patients are treated with cisplatin annually. Similar numbers over in Europe, and effectively, globally, it's as a percentage of the population.
In the US, pediatric cancer is largely concentrated. You can see it in the larger Metropolitan Statistical Areas, 200 primary hospitals, with the majority of pediatric cancer treated at these key centers. Moving on to the AYA population. Again, that is the population going up to the age of 39. That population is nearly tenfold the population of the pediatric market, or over 20,000. Some of the top tumor types we have already discussed.
That is a market that with our new leadership team, we have really started to make some inroads and been successful at executing and building both the brand and the awareness and the education of that product. A little different than the market from a pediatric perspective. You can see here in the AYA population, it's spread out.
Largely, the AYA population is seen by community centers with approximately 80% of the patients. What we did was we modified our sales approach as a result. Going back to the pediatric at the larger cities, the bigger Metropolitan Statistical Areas, we had a sales team of roughly 10 territories. In March of this year, we expanded our sales team to 24 territories to be able to more effectively and frequently cover this market here in the AYA market.
W e believe there's a clear path to value creation. You can see it in our numbers coming up, but also in our team. We've grown from territories from 10 to 24 territories. We've expanded our medical awareness and reach, and we brought in a new leadership team, really with the key focus of driving execution for PEDMARK.
It starts with the awareness, establishing PEDMARK of the standard of care, having an initial successful trial adoption, and then with those doctors being able to augment that PEDMARK use into more components of their patient population.
We're very successful on the payer approach with over 90% reimbursement rates, significant inroads in advocacy, and we have tremendous amount of goodwill being built in the community itself as we've grown that population use. Some of the similar components you'd find with any commercial team, we've built brand and awareness.
We just had a big booth over at ASCO for the first time ever, as we've grown from pediatric to AYA. We've aligned our commercial and medical infrastructure. We've grown from 30 FTEs to 60 FTEs. Very important here is establishing the KOL engagement and KOL understanding of the product.
That takes time, and you can see that in both the growth of our business, but also in some of the speaker forums that we've been able to have with these KOLs. Lastly, we have a fully ramped up Fennec HEARS program that answers any questions medically and also provides any logistical supports for the product. Another picture of the footprint, which I talked about earlier. Europe, we have a partnership with Norgine.
We are very excited that in the H2 of 2026, they are launching in 10 markets, so we look forward to being able to announce more of their progress in the coming quarters. I touched upon the Middle East as a potentially very attractive market where reimbursement is significant and the understanding of the impact of cisplatin as well.
In Japan, where we announced preliminary top-line results late last year. We will have another announcement later this week as it relates to those results, and we also look forward to embarking on registration and commercialization with a partner here in the near future. We're not stopping. We'd like to continue to generate clinical evidence to support wider use of PEDMARK. What are a couple of the areas with some potential wider use of PEDMARK?
The adult population, where cancer is most prevalent, much larger population than the AYA population, as well as the metastatic population. We've announced three investigator sponsored trials with some very prominent institutions in the City of Hope, Tampa General Hospital, and the University of Arizona.
As you can see by these ISTs, largely focused on the adult population as well as in the metastatic population. By order of magnitude, I mentioned that the AYA population is approximately 10 x the size of the pediatric population. The adult population is about that same amount of magnitude increase, 10x .
Fennec HEARS I touched upon as well. A lot of success getting reimbursement, over 90% reimbursement across the biggest plans. A lot of support we provide to patients. We really want no patient to be left behind, and we also have a great partner in home health, so a patient can go get their cisplatin, get their cancer, go home, and then through our partner, we can have a nurse go and administer six hours later the PEDMARK.
We're on the NASDAQ. I think one part here to note is we have a clean balance sheet, absolutely no debt, $40 million of cash as of June 30th. For the first quarter ever, we reported on our report EBITDA, and nearly $3 million of EBITDA important there. We have a fixed cost base of $50 million in cash OpEx.
As we generate roughly north of the $14 million, $15 million of net sales, the EBITDA will continue to grow. Very scalable business. Here's a chart of our revenue growth. Our CEO, who is in the audience, Jeff Hackman, you can see since his leadership and the new team coming in, we have grown seven quarters in a row, more than doubling our revenue. Important here to note, what I like to highlight is we were largely a pediatric-focused company until Jeff joined us.
Thereafter, a big part of that growth is the AYA market. If you did the math in terms of where we are, we are just getting going, and I am happy to explain that to you later in terms of the penetration on AYA. We made a big bet in March of 2026 in terms of more than doubling our sales force.
Our FTE count has doubled, but as I mentioned, our costs are effectively flat at $50 million in cash OpEx per year. As we grow our revenue over that $14 -$15 million, every dollar should go down to EBITDA. With that, I will take any questions if there are any.
Yeah, perfect. We have a minute left if anyone would like to ask any-