Prepared remarks
Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceuticals Second Quarter 2026 Earnings and Corporate Update Conference Call. As a reminder, today's conference call is being recorded. Now I'd like to turn the conference over to Fennec's Chief Financial Officer, Robert Andrade.
Thank you, operator, and good morning, everyone. We would like to thank you for joining us. We are pleased to host Fennec Pharmaceuticals' Second Quarter 2026 Earnings Conference Call today, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning is our Chief Executive Officer and Board member, Jeff Hackman; our Chief Commercial Officer, Terry Evans; and our Chief Medical Officer, Dr. Pierre Sayad. I am also pleased to welcome our Chief Strategy Officer, Christy Cioffi, who is joining our earnings call for the first time. Christy has more than two decades of leadership experience spanning commercial strategy, brand building and organizational development, including nearly 15 years of expertise leading award-winning commercialization and launch strategies across the product life cycle. She has held senior commercial leadership roles at a number of leading biopharmaceutical companies, including Shield Therapeutics, Stemline Therapeutics, EUSA Pharma, Karyopharm Therapeutics, Servier, previously Shire/Baxalta/Baxter and Abbott Laboratories, where she helped build and grow oncology, rare disease and hematology brands from early development through commercialization. As a graduate of West Point, Christy also served our country as a decorated U.S. Army veteran and Bronze Star recipient, leading soldiers during two deployments in Operation Iraqi Freedom. Later in the call, Christy will speak to how recent cross-functional efforts are supporting our long-term growth plans. Additionally, Dr. Pierre Sayad will provide a medical affairs update and Terry Evans will speak to our commercial progress. Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. Reference to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the United States Securities and Exchange Commission. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on Fennec's website, www.fennecpharma.com, where it will be available for the next 30 days. I will now turn the call over to Jeff Hackman.
Thank you, Robert, and good morning, everyone. Thank you all for joining us here today. So before we dive into the quarter, I'd like to take a moment to reflect on how far we've come as an organization. Two years ago, I joined Fennec with clear objectives: build the team, sharpen our execution and position the company for sustainable long-term growth. Over that time, we've built a talented and experienced leadership team, deep expertise across commercial, medical affairs, clinical development and corporate strategy. Today, you'll have the opportunity to hear from each of them about the progress that they're making in their business. We also expanded our customer-facing team, as you know, to reach a larger prescriber target base with a greater frequency, increasing the numbers from 1,300 to roughly 5,000 targets. Together, we've built an organization that is focused, accountable and aligned around delivering for our patients, our health care providers and our shareholders. I'm proud of what we accomplished. Since I joined the company, we've increased revenue by 143%, driven by a unified strategy, consistent execution and a disciplined focus on the fundamentals of our business. Perhaps most importantly, we've demonstrated that this isn't the result of any single initiative or quarter. It's been built through steady execution, expanding our commercial reach, strengthening our clinical evidence base, investing in targeted talent across this organization and maintaining a strong financial foundation. Today's results, including our seventh consecutive quarter of growth, reflect momentum we've created and the commitment of our entire organization. I'd like to thank everyone here and take this opportunity to thank all Fennec employees for their exceptional work to help ensure that these patients facing cancer treatment can continue to hear the moments that make life most meaningful. While we're proud of our progress, we also believe we're still in the early stages of our opportunity. As you'll hear today, we're continuing to invest in the drivers that we believe will support long-term growth from generating additional clinical evidence and expanding physician engagement to building awareness and ensuring that we have resources to execute on our strategies. One of those drivers in Q2 was breaking new ground in a disease awareness campaign, bringing the conversation around testicular cancer to the Indianapolis 500 and introducing Fennec and our mission to millions of fans and forging meaningful connections across the oncology community. Christy will go much deeper into detail and the impact of this campaign shortly. As a reminder, PEDMARK is currently approved for pediatric patients 1 month of age and older with localized non-metastatic solid tumors and is also recognized by the National Comprehensive Cancer Network with the 2A recommendation for use in adolescent and young adult patients. As we look ahead, we believe the investments we've made across our commercial organization, the clinical evidence generation efforts and the financial foundation is translating into meaningful momentum. Encouraged by what we've seen so far in the third quarter, we are confident in our ability to continue to build on this progress and deliver sustainable growth. So with that, I'll turn it over to Christy for a more detailed update on our disease awareness efforts and our presence at ASCO.
Thank you, Jeff. As Jeff just mentioned, over the past two years, we've been very intentional about evolving not only how we position PEDMARK, but also how we engage the oncology community. In 2025, we reinvented our commercial approach with a bold, differentiated branded campaign called Survival Should Be Loud. This campaign challenges convention, resonates strongly with oncologists and has helped to establish a leadership position for both PEDMARK and Fennec. Building on that momentum, 2026 represents the natural next phase of that evolution. In May, we launched a disruptive disease awareness initiative to wake up a broader audience to the issue of cisplatin-induced hearing loss, or CIO. As we've shared in the past, cisplatin is the cornerstone of testicular cancer treatment, transforming the disease from a frequently fatal diagnosis to one with a cure rate exceeding 95%. In support of this community, we created an innovative campaign targeting testicular cancer awareness called Indy's Nuts. This campaign with multiple strategic collaborations launched at the Indianapolis 500, one of the world's largest sporting events. Through sponsorships with racecar driver Jack Harvey and NFL linebacker Alex Singleton, the campaign was intentionally designed to stop people in their tracks. This bold unexpected creative concept included distribution of over 100,000 bags of peanuts. We sought to capture attention, spark curiosity and encourage audiences to learn more. Our two important objectives: first, to encourage men to perform regular testicular self-exams and promote earlier diagnosis of testicular cancer; and second, to educate patients diagnosed with testicular cancer about the importance of discussing CIO and hearing prevention with their care teams before treatment begins. Additionally, we sponsored an educational event with leading key opinion leaders from a renowned institution in the region to deepen understanding of CIO prevention and the role of PEDMARK. Importantly, the initiative demonstrates our ability to reach and engage audiences well beyond traditional health care settings, further expanding awareness of both the disease and the unmet need surrounding CIO. We are extremely pleased by our campaign performance metrics that exceeded industry norms in several categories. The momentum did not stop at the Speedway. We carried that same energy and awareness into the ASCO Annual Meeting, where the racing theme became a natural conversation starter at our booth. Through the draw of racing simulators and interactive experiences, we engaged with oncologists, advanced practitioners, nurses, patient advocates and industry leaders in meaningful discussions about hearing preservation and the role of PEDMARK in addressing the unmet need of CIO. Throughout the meeting, the Fennec Speedway generated exceptional engagement and quickly became one of the most talked about exhibits on the show floor. It was even featured as a part of ASCO's wrap-up coverage. Our cross-functional team generated hundreds of health care professional leads and received overwhelmingly positive feedback from attendees who appreciated both the interactive education and the important clinical conversation the booth enabled. Pierre will speak more about ASCO shortly. For us, that was the ultimate validation. ASCO wasn't simply memorable. It created an effective platform to educate health care professionals, amplify our mission and reinforce Fennec's leadership in changing the standard of care for the prevention of CIO. With that, I will now turn the call over to Pierre for a medical update.
Thank you, Christy, and good morning, everyone. The second quarter for medical affairs was one defined by expansion. We have a fully trained, fully deployed medical science liaison team. This team engaged with a record number of new health care professionals as well as affiliated sites and health care organizations in Q2, adding significantly to an already growing target base. In fact, our total unique HCP reach increased 63% and unique affiliated sites increased 72%. This team is successfully converting the scientific field engagements from HCP educational gaps to further clinical conviction as we collaborate across functions to change the standard of care with PEDMARK. During the quarter, we also advanced our evidence generation efforts with impactful presentations at ASCO and through an expanding portfolio of investigator-sponsored studies, or ISTs. In April, we announced a third IST with the University of Arizona Cancer Center to evaluate the use of PEDMARK in adolescent and young adult and adult patients with head and neck and testicular cancers receiving cisplatin. This news follows the initiation of two other institution-led clinical studies with Tampa General Hospital Cancer Institute and the City of Hope. These studies are actively accruing patients. We are also engaged in discussions to grow this pipeline of ISTs, which will further expand our understanding of PEDMARK's potential. Importantly, these conversations are across multiple tumor types and across various patient populations. One of the most encouraging takeaways from our presence at ASCO in June was the evolution of the conversation. Discussions are now moving beyond general awareness of cisplatin-induced hearing loss to implementation with health care providers asking practical questions about incorporating PEDMARK into standard treatment workflows. We believe this reflects increasing clinical confidence and growing momentum towards broader adoption. In Q2, we nearly tripled our medical congress footprint at both national and regional conferences. At these meetings, gynecologists were of particular interest and generated significant discussions and insights surrounding the market opportunity in this area. We heard from multiple leading academic gynecologists that there is limited PEDMARK awareness despite recognizing CIO, reinforcing our medical affairs strategy to expand structured education into gynecology alongside head and neck and testicular cancers. These specific tumor areas account for nearly half of our medical target base. Our field medical team plays a critical role in the education of physicians. The depth of our team's scientific knowledge and respected standing within the academic community are a true competitive advantage. Our evidence generation strategy continues to gain momentum beyond ASCO. We are pleased to share that the investigator-initiated Phase II/III STS-J01 clinical trial evaluating PEDMARK for the reduction of CIO in pediatric and adolescent and young adult patients with non-metastatic solid tumors in Japan has been selected for an oral presentation at the SIOP 2026 Annual Meeting in September. These data will mark the first public presentation of human pharmacokinetic data, representing an important milestone in deepening our understanding of the clinical profile and potential of PEDMARK to change the standard of care. Oral presentations are reserved for research considered to be of particular scientific interest. And we believe this recognition reflects the growing clinical focus on preventing hearing loss in children receiving cisplatin-based chemotherapy. We look forward to sharing more details on the full results in September. Together with the data shared at ASCO earlier this year, these presentations continue to expand the scientific dialogue around hearing loss prevention and reinforce our commitment to supporting the generation of high-quality evidence. And with that, I will now turn the call over to Terry for a commercial update.
Thank you, Pierre, and good morning, everyone. Our newly expanded sales force is driving a positive impact in the first quarter. Commercial demand continued to grow in Q2, which is attributed to our disciplined execution and greater reach and frequency with prescribers underscoring we have a repeatable and scalable platform for growth. For example, in the second quarter, we saw a 280% increase in the number of sales calls made by our field sales team. Demand in Q2 grew double digits over Q1, driven primarily through our patient services hub called Fennec HEARS. In fact, Fennec HEARS saw a significant increase in patient enrollments that led to an all-time high number of infusions for the quarter. Q2 also delivered record adolescent and young adult enrollment supported by the NCCN 2A recommendation. Additionally, more than half of our business came from the home infusion setting. This flexible at-home scheduling option works for both patients and providers by making it easier to start therapy and to stay on therapy. Importantly, this record patient enrollment in Q2 has helped create real momentum with unprecedented demand carried into the third quarter. In fact, in the month of July, we reported an all-time high of completed PEDMARK infusions, new patient enrollments, active patients on therapy and new customers in a single month. As we have discussed previously, continued commercial growth depends on strong alignment and execution across our organization. We are encouraged by how our expanded sales force has partnered with our market access and medical affairs teams to deliver a coordinated customer experience as we work to change the standard of care with PEDMARK. To give you an example of this teamwork in action, these groups recently collaborated to secure a major formulary addition with a nationally recognized community oncology network. By combining strong sales and account management with compelling clinical education, we successfully added PEDMARK to their formulary, which expands access and creates new opportunities for patients. This achievement demonstrates the strength of our integrated commercial model and our team's ability to drive meaningful results. In summary, there are several positive trends that we're carrying into Q3, including overall vial demand, number of vials per patient, new patients entering the funnel and infusions ordered and completed. We are optimistic that this commercial success will continue to reach record levels in the second half of 2026. With that, I will turn the call over to Robert for a financial update.
Thank you, Terry. Our press release contains details of our financial results for the second quarter of 2026, which can be viewed on the Investors and Media section of our website. As customary, rather than read through all of those details, my comments today will focus on some key financial results. Of note, a table reconciling non-GAAP measures was included in today's press release for reference and will be in our accompanying 10-Q filed with the SEC. For the second quarter of 2026, the company recorded net product sales of $17.1 million compared to $9.7 million in the second quarter of 2025, representing an increase of approximately 78% year-over-year. We witnessed the highest amount of new patient enrollments in the second quarter and carry record demand for PEDMARK into the third quarter. On the OpEx side, which we define as research and development and selling, general and administrative expenses, excluding stock-based compensation, it was approximately $13.6 million for the quarter, with a year-over-year increase of approximately $3.6 million. The majority of the increase was in SG&A with expanded marketing investment focused on awareness initiatives and increased commercial headcount supporting PEDMARK growth. Consistent with prior commentary for 2026, we expect approximately $50 million in total cash OpEx in 2026, with approximately $20 million to $22 million or 40% of those expenses left to be recorded in the second half of 2026. We are focused on EBITDA generation and cash flow as we grow the business and as such, are presenting record non-GAAP adjusted EBITDA in the second quarter of approximately $2.8 million compared to a loss of $1.2 million in the comparable quarter a year ago. We have significant leverage in the business with a predominantly fixed cost base. And as our revenue growth continues, we anticipate operating income and non-GAAP adjusted EBITDA to grow meaningfully in the quarters to come. EPS in the second quarter of 2026 was $0.05 per share compared to a loss of $0.11 per share in the comparable quarter. Cash and cash equivalents were $41.2 million as of June 30, 2026. For the quarter, there was a $1 million increase in cash and cash equivalents, which was higher than we anticipated for the quarter. As we have stated previously, as we grow the business, we anticipate select quarterly swings in cash position based on collection cycles with customers and as such, expect the third quarter ending cash to be lower than the second quarter. However, we expect the fourth quarter cash generation and our year-ending cash to be positive. Lastly, as we stated in our press release, we anticipate that our cash, cash equivalents and investment securities as of June 30, 2026, coupled with the projected revenues from PEDMARK will be sufficient to fund our business based on our current operating plan. Operator, with that, we are now ready to open the call for questions.
Questions and answers
And our first question comes from the line of David Amsellem of Piper Sandler.
So just a few for me. First, regarding the testicular cancer population. Can you talk to how much of your overall patient mix right now is coming from young men with testicular cancer? That's number one. Or maybe asking another way, what portion of your new starts on PEDMARK are in testicular cancer patients? And then secondly, can you give us a sense of the mix between usage in academic centers versus community oncology practices? And how is that trending? And then lastly, I wanted to pick your brain on life cycle management and what you think you can do or have you even thought of ways to better improve the profile of PEDMARK?
Perfect. Thank you. This is Jeff. I'll take these, and then we'll kind of pass them through some of the folks here. So thanks for the question. I appreciate it. Testicular cancer continues to be a driver for our business. It's the largest adolescent and young adult tumor type that fits our PEDMARK profile. So those numbers for AYA, the size of the market is larger than the rest of the tumor types. Again, we're agnostic on tumor types, as you know, because we target cisplatin usage. And it doesn't matter what tumor type it is. It's still going to have the impact to the hearing. So maybe I'll have Terry talk a little bit about the testicular market, and he can kind of give you a little bit more detail, and then I'll jump back to the academic and community setting. Go ahead, Terry.
Yes, sure. And what we're seeing is roughly typical of what we had in Q1. However, slightly better in testicular cancer in Q2 with regard to that particular tumor type and PEDMARK utilization. We've got over 80% of our business right now between testicular, cervical and head and neck. And predominantly, it is testicular that's the larger driver of all of those. And it really does speak to our commercial execution sticking on our targeted plan, our sales force calling on the right folks at the right time and then collaborating with our colleagues in market access as well as medical that's really driving the business forward. The next question was about academic versus community. So we see a really nice balanced approach between both academic and community. I mentioned a formulary win in the community, but we've also seen really fantastic things happening in our academic setting as well. I wouldn't characterize it by one leading more than the other. Both are growing really nicely with the additional sales force that we have.
Yes. Perfect. Thank you, Terry. And the last is the life cycle management. Your comment on that's a good one. And I might have Pierre touch on that a little bit because I think what you're hearing from us from a life cycle side is really coming from some of the ISTs that we put out there. There are a few areas where we think we can significantly grow the business, potentially even based on publications from these ISTs as the data comes in over the next few years. So Pierre, maybe talk a little bit about some of those areas that you see from your ISTs.
Sure, sure. So thank you for the question. The data generation is really leading to kind of a multipronged approach, if you will. So as patients are quickly accruing across the three existing ISTs, so City of Hope, University of Arizona and Tampa General Hospital, we have an abundance of increased interest in additional ISTs. And importantly, these are across tumor types, across patient ages and localized as well as metastatic disease. So as the data matures, we are certainly having discussions with the regulatory agencies to see is there opportunities for label expansion. Additionally, we are very, very keenly looking at NCCN guidelines and seeing opportunities for having increased guideline recommendations there as well.
Our next question comes from the line of Chase Knickerbocker of Craig-Hallum.
Congrats on the results here. Maybe just as far as how kind of that productivity of the new reps is trending, were they meaningful contributors to Q2 growth? Just trying to get a sense for what inning, how early are we in kind of their productivity ramp?
Sure. Thanks for the question, Chase. I'll take a little bit of it, and then I'll give it to Terry. But you heard from some of my comments, we now are approaching close to 5,000 targets that we're calling on. It is having an impact. We're seeing patients in places in the country where we've never seen patients before. And as we even hinted a little bit on our Q3 numbers, our July continued that momentum that we're seeing. So one of the things we said early on was give these guys a little time. Now they've had a quarter under their belt, but they're still going to continue to grow and get better at what they do. They need to understand where they're going. Multiple times, we have to be in these offices, obviously, before we can move physicians. And so give them a little time. But what I would say is that the growth of what we're seeing, a lot is coming from our new reps. And maybe, Terry, you can comment on the success of what you're seeing too.
Yes, there's no doubt about that. The new reps are adding to the success. And across the board, coast to coast, these are fantastic people, great humans to start with, but really good salespeople. And they're decorated before they got here. And it's not really an accident looking across there for us that I mentioned the cross-functional model, the collaboration that we have with our medical affairs team as well as our key account team. It's in that collaboration where these guys are doing such a wonderful job. There's consistency. They're hustling every day, and it really resonates in seven straight quarters of growth. So I'm super proud of these guys. They are on the curve, though, keeping in mind, Jeff mentioned this that they started in early March. And we've got one full quarter, and they're on the growth curve of their education and them getting around to see everybody.
Yes. But I can tell you the seven straight quarters, and we mentioned July, and I think Terry commented on it, Chase, July, we recorded a new all-time high of completed PEDMARK infusions, a new all-time high of patient enrollments and also an all-time high of active patients. And so you're seeing new customers, a record month in July, and we don't plan on slowing down. So I hope that answers your question, Chase.
It does, Jeff. And maybe just to kind of piggyback on that comment a little bit. Growth accelerated again sequentially in the second quarter. You just kind of talked about kind of record demand you're carrying into Q3. It seems like we've got meaningful potential utilization gain to still get from some of those newer reps. I mean with all that together, should we be thinking about your business accelerating from a growth perspective sequentially? Maybe just give us a little bit more color as far as exactly kind of what you're seeing in July and how we should think about the back half of the year here as your business is clearly starting to.
I'll comment and then I'll let Robert jump in, Chase. But we have said the back half of the year is where we'll see our growth, and we're showing growth in the first and second quarters. So yes, your question is how fast and how big and where do we see this going? When we came out of the first quarter, April was a record month for us as we entered the second quarter. Now we're coming out of the second and going into the third, and July is a record month for us. So we're continuing to see significant growth. I expect that to continue through this third quarter and into the fourth. Maybe, Robert, you can comment from your side on some of the things that we share.
Yes, Chase, just to echo really Jeff and Terry's comments, July was an outstanding month. Early on in August, obviously, we're August 11, that continues. And also in line with that, the productivity curve, we expect to ramp up. So we're not going to get into details in terms of how much growth, but needless to say, we are quite pleased with where we stand today in the third quarter.
And our next question comes from the line of Raghuram Selvaraju of H.C. Wainwright & Co.
Congratulations on a very solid quarter. Firstly, I wanted to ask about what your outlook is with regard to the time line with which you might be in a position to provide us with a revenue guidance range, if not for this year, then potentially for 2027. Secondly, I was wondering if you could provide us with any granularity on when you anticipate a potential shift in NCCN guideline category classification for PEDMARK based on the available evidence. I was also wondering if you could tell us a little bit about ways, potential techniques, strategies to ensure that enrollment pace in the various ISTs, both the ones that are currently enrolling and the ones that you expect to come online would proceed at a reasonable, if not accelerated pace? And then lastly, if you could just give us an update on potential launch preparations or commercial assessments in preparation for the introduction of PEDMARK in Japan and how you are thinking about partnership strategy over there, that would be very helpful.
Sure. Great questions. Thank you. I'll start and then hand over to Robert. We have said repeatedly that we do not provide formal revenue guidance, and we have not done so for this year. That said, we are encouraged by the trends we are seeing. We are discussing whether we can enter 2027 in a position to provide guidance for 2027. As you grow a company this rapidly and make so many changes, the worst thing you can do is miss guidance, so we have been cautious. We will be in touch about our approach to guidance for 2027. On your question about ISTs and enrollment, I will let Pierre speak more about that because you were asking about enrollment and some of the numbers. We do not publicly report those numbers, but we can comment on the momentum we are seeing.
Sure, sure. So obviously, we need to be very careful that we, as a company, don't interfere with IST accruals for compliance reasons. That said, we have helped each institution drive awareness within their own circuits, allowing all the other physicians to know that the ISTs are open and actively accruing. So we are very encouraged by the early numbers that we're seeing. And so yes, I'll stop there on that in terms of IST accruals. In terms of the question for NCCN, we have a very focused strategy as to when this data will finally mature so we could take it to different NCCN boards, including head and neck, gynecologic as well as testicular. But it really is a function of getting the data.
The other is Japan. And one of the things you had asked about kind of where is the status and where do we look like with the partnering and licensing opportunities in Japan. We're encouraged by the discussions that we've been having. As you heard from Pierre, the data is now getting picked up at multiple meetings, not just ASCO, but now SIOP. So there we're excited about the STS-J01 data and potential opportunity it represents. We have been engaged with a number of folks in Japan on the ground, both — as a matter of fact, Pierre and I will be there next week meeting with our team in Hiroshima as well as meeting with potential partners and partners that we've been in discussions with for a while. Our focus really is we want to have the right path forward for the product there and not just for Japan, but for Asia Pacific. So we're taking our time, but we want to do this right, and we want to maximize the long-term value for that region for this product. But most importantly, also, we want to get this product approved in Japan as fast as we can. So I hope that answers your question.
Yes, it does. And one last quick one. Jeff, I know I've asked this a couple of times in the past. And I was just wondering if there has been any evolution in your strategic thinking regarding the possibility of in-licensing anything that might be complementary to PEDMARK for your sales force to sink their teeth into, given the fact that you've now built up a very good head of steam with that product, are you thinking about potentially other opportunities commercially speaking, within oncology supportive care?
We are. And we talked about this in the past. And now that the team is really starting to perform and execute the way they are, you can imagine that there's an opportunity to be able to put something else in their bag, so to speak. So we're looking at it. We get opportunities coming across our desks. All of us here that you've heard on the call all are helping evaluate these opportunities. So yes, we continue to do that. We haven't seen anything just yet, but we're open to those discussions, as you know.
I'm showing no further questions at this time. I'll now turn it back to Jeff Hackman for closing remarks.
Perfect. Thank you. So thank you all for joining the call today. And as you know, and especially the questions and your participation here at the end, thank you. In summary, as you know, we execute an incredible set of priorities here at the organization. They reinforce our long-term growth, they advance the clinical evidence and they drive commercial performance. And we maintain a strong financial position as we continue all of these initiatives. Combined with the encouraging trends that we're seeing early in the third quarter, we believe we are well positioned to continue to sustain our growth and momentum throughout the remainder of the year. I want to thank you all for joining the call today, and this is the end of Fennec's second quarter call.
Thank you for your participation in today's conference. This concludes the program. You may now disconnect.