Q3 2025 Verastem Inc Earnings Call
Good morning and welcome to Verizon East third quarter 2025 earnings conference. Call my name is Liz and I'll be your call operator for today.
Please note, this event is being recorded, all participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. I will now turn the call over to Julissa Vienna, vice president of corporate Communications, investor relations and patient advocacy at verisim. Oncology, please go ahead.
Thank you, operator, welcome everyone. And thank you for joining us today to discuss. Fair Sims, third quarter, 2025 Financial results, and recent visits Updates this morning. We issued a press release detailing our financial results for the quarter, and year to date. This release, along with the slide presentation that we will reference during our call. Today are available on our website.
Before we begin I would like to remind you that any statements made during this call are not historical and are considered to be forward-looking statements within the meaning of the private Securities. Litigation Reform, Act of 1995.
Actual results May differ materially from those indicated by these statements as a result of various important factors including those discussed in the risk factors section in the company's most recent annual report on form, 10K filed with the SEC in March 20th 2025 and the current report on form. 102 that will be filed later today as well as other reports filed with the SEC. Any forward-looking statements, we make represents vims views as of today and we disclaim any obligations or responsibility to update.
Joining me on today's call are Dan Patterson president and chief executive officer of VM, who will provide opening remarks and recap key highlights from the quarter Matt Ross Chief Operating Officer and Mike Crowder Chief commercial officer who will walk through the continued progress of the fnati vaccine. Copac commercial launch and Dan Caulkins Chief Financial Officer who will provide an overview of our financial results.
I will now turn the call over to Dan.
Thank you, Julissa. Good morning, and thank you for joining us today to discuss our third quarter Financial results and business update.
In Q2, we shared our excitement about achieving FDA approval for a mapapi facts in your copac in cos mutated recurrent low-grade. Cirrus, ovarian cancer or LG SOC and reported our first 6 weeks of commercial performance.
Today, I'm pleased to share that the strengths we saw in those initial weeks as accelerated.
With a full quarter of commercial operations. Now, complete the fundamentals, we put in place to guide. Our commercial launch are translating into meaningful results.
Our third quarter, net product, revenue of 11.2 million, surpassed our expectations and was driven by consistent, adoption among both academic centers and Community oncologists
We set three key objectives to support our commercial execution and drive sustainable growth.
Physician engagement.
Patient initiation and retention and streamlined reimbursement, all 3 are trending positively.
We're simultaneously advancing our broader, strategic priorities, specifically expanding the opportunity set for a Mappy facts in your copac and accelerating the clinical path of Zs 7375 our kras g12d on off. Inhibitor program.
Let me highlight a few achievements.
We completed the enrollment of our expansion cohort and ramp 205. Our first line pancreatic cancer trial, evaluating a vutta plus deactivate and standard of care chemotherapy.
We completed the plan enrollment of our confirmatory, phase 3 clinical, trial ramps, 301, and recurrent LGS SOC and will be making a modest increase in enrollment per the ID. MC's recommendation.
This does not have a meaningful impact on our expected timelines.
Ability data from our g12d program, the vs 7375.
We cleared 2 monotherapy doses with do no dose. Limiting toxicities. We reported that we did not observe nausea. Vomiting or diarrhea above grade 1.
Importantly, these dose levels included the phase 2, go forward dose, that was chosen by our partner in China.
We're now moving ahead opening the combination cohort with the toxin that.
These are exciting developments that add to our continued success. In the fourth quarter, we remain focused on our three key launch objectives and maintaining our execution discipline across all commercial, clinical, and operational functions.
Let me now turn the call over to Matt to review some specific highlights from the third quarter.
Thank you, Dan. The strong FM map, defects, and your copac growth reflect the high unmet medical need and physician enthusiasm for this first-ever treatment option.
The team has achieved significant results since our May approval, and we continue to execute well against all three strategic launch imperatives.
Dan touched upon these, and they are
First to effectively reach Healthcare Providers, remembering that the top 100 Commercial Healthcare organizations.
Comprise about 50% of the sales opportunity.
Second to engage and support patients throughout their Journey. As we know that, as patients progress through other therapies, many will be ready for a new treatment option and third to ensure seamless access. So we can support patients and ensure any barriers to reimbursement, are removed.
Our approach is highly targeted, and we're utilizing a deliberate mix of 1-on-1, meetings group discussions and Conference engagements to maximize the impact of every interaction. In this rare disease Market,
Thus, far each element of this approach has proven to be successful.
as Dan shared, we generated 11.2 million in net product Revenue in the third quarter which was our first full quarter of launch
We've leveraged the momentum from the first 6 weeks of launch and uptake has been strong.
With 133 prescribers of that Mac defects engine compact position. Excitement is palpable, and our field teams continue to do an excellent job in engaging with healthcare providers to ensure they understand the unique benefits of the copac and how to administer it.
Consistent with Q2, we continue to see prescriptions generated by gynecological oncologists and medical oncologists.
This well-rounded basic prescribers reinforces the touch points. Our teams are making across our top 100 organizations and Tier 1 and tier 2 targets.
We are experiencing high levels of Engagement within Community practices that are either large Affiliated practices or are associated with group, purchasing organizations,
We are also having meaningful success in accounts that are typically closed to sales representatives.
We continue to engage in support patients, with Outreach efforts, to help, educate them about the treatment and support their conversations with their doctors.
And while we won't be speaking to Future Trends or prescriptions, at this time, we are encouraged by specific insights following, our first full quarter of launch
Approximately 65% of prescriptions written have been generated by our top 100 organizations.
What's great about this is that we are making strong Headway and our Tier 1 and tier 2 accounts, but we are also seeing prescriptions coming from other accounts as well.
We believe that speaks to the strength of the data and brand awareness.
More than half of total prescriptions are coming from the academic setting and we expect the split to be consistent between the community and academic setting providers over time.
60% of the prescriptions written are coming from GYN, oncologists and 40% written from medical oncology.
A specialty distributors are now fully onboard, and we see a good mix between the two specialty pharmacies onboarded in Q2 and the four specialty distributors we added this quarter.
The initial orders across our specialty distributors were managed closely and have been consistent with the initial orders from our two specialty pharmacies at launch.
For these reasons, we believe inventory stocking has been minimized and we plan to continue to manage this closely through year end,
Lastly, reimbursement has not been a barrier to any access and light will provide more specifics in that regard shortly.
Fourth quarter, we aim to continue to build on our momentum while staying laser focused on our strategic imperatives to ensure every appropriate patient benefits from this novel treatment.
The key opinion leader Community continues to reinforce our thesis that every cos mutated LG SOC, patient should not only receive this treatment but should do so at their first recurrence.
Given our early achievements, our team's effective execution and the high unmet need. In this rare form of ovarian cancer, we believe we are well positioned for continued growth.
Now, I will turn the call over to Mike to speak further about the launch Dynamics.
Mike.
Thanks Mom. Let's get right into the specifics of our aati, Fox injury, copac launch an extremely pleased with how well the launch is going as net product, Revenue growth accelerates in the third quarter, while we consider ourselves still. In the early days of launch, the underpinnings of success is built upon the breadth and reach of our field engagement to raise awareness of the availability of the first ever treatment specifically, for people living with, cos mutated recurrent, LGS SOC.
These impressive results are driven by a few key factors: high unmet need, increased engagement with both academic and community oncology practices, expanding reach, and removing barriers to access through specialty distributors and their GPO partners, along with continued efforts to ensure seamless access.
From an engagement standpoint in the third quarter, we have had high engagement among our top 100 organizations, and top 100 officers, which includes a mix of academics and Community providers.
These efforts have resulted in approximately 65% of prescriptions coming from them, specifically within our Tier 1 and Tier 2 accounts.
We continue to see both repeat prescriptions from Physicians prescribing to multiple patients and refill for patients. Given the Poco packs, favorable safety profile.
An important Insight, we have gained is the hcp's treating, LG SOC. Have a good understanding of where their patients are in the treatment journey and are keeping copac top of mind, for when that patient's current therapy fails due to either intolerable or clinical progression,
Doctors continue to share that they are actively assessing and identifying patients. That may become appropriate candidates for this targeted, combination therapy demonstrating that her efforts with hcps. Are creating visibility into new patients becoming available for treatment.
Additionally the awareness about map key facts in your copac is high, our Medical Science liaison and oncology nurse Educators have engaged in 800, scientific exchanges and well over 100 educational forums with Healthcare Providers within this quarter alone.
We Believe payers are at knowledge in the unmet needs that can now be addressed by the co-ack, as well as the clinical value of the combination therapy.
The payer coverage continues to be Broad and the time to fill prescriptions has been fast within approximately 12 to 14 days. We can also confidently, share the covered lives has now exceeded 80%. And that the payer mix for our combination therapy is about half commercial and half Medicare
From a patient perspective, we continue to see high engagement in our branded website. Our digital campaign is effectively driving traffic to this resource and patients are downloading. Our patient brochure and opting in to receive more details associated with how the copra can be appropriate for them.
To close. We strongly believe that the admat key facts in combination therapy has the potential to make a significant impact on the lives of patients. Who previously had no treatment options, specific to their disease, with several months. Now under our belt, the team is executing well against all our launch objectives, we continue to believe a steady adoption will occur over time and our early observations post approval support this perspective. I look forward to sharing more in the coming quarters as we progress through the launch and gain more experience and insights with that. I'll turn the call over to Dan Kalin to provide an update on our financials.
Thank you Mike. We use it to press release before the call today with the full Financial results. So we'll focus on the highlights for the third quarter.
In our first full quarter of launch, I'm also a place to report 11.2 million of net product revenue for the third quarter cost, of sales were 1.7 million. So the third quarter of 2025 and did not include a significant amount of product costs as inventory, produced prior to FDA approval, was fully expensed at the time of production,
Currently, we are not providing guidance on gross net, other than to say that expectations should be consistent with other oncology small molecule Therapeutics.
Around 301 clinical trial and the ongoing vs 7375 phase 128 clinical trial, as well as higher costs associated with drug substance production activities related to Via 7375.
Sgna expenses were 21.0 million for the third quarter. The expenses were driven by commercial activities in operations which included Personnel related costs to support the ongoing CPAC launch. We continue to be prudent in our expense management. Making the right Investments at the right time to support the ongoing commercial launch efforts. While simultaneously advancing our pipeline,
For the third quarter of 2025, non-GAAP adjusted net loss was $39.4 million, or $0.54 per diluted share, compared to a non-GAAP adjusted net loss of $35.3 million, or $0.88 per diluted share, for the 2024 quarter. Please refer to our press release for a reconciliation of GAAP to non-GAAP measures.
Moving to the balance sheet. We ended the third quarter of 2025 with cash cash equivalents and Investments of 137.7 million.
We believe our current cash combined with future revenues from a mass keep expenditure copics sales and the exercise of the outstanding cash warrants provides Runway into the second half of 2026.
Being a solid First full quarter as a commercial company. We have sufficient Capital to fund our ongoing commercial launch in the US and continue advancing, our current clinical development plans, with that, I'll turn the call back over to Dan.
Thanks, Dan. Before we open the call to Q&A, I'll share a few final remarks to close out today's presentation.
We've seen another strong quarter of execution at varsome as we continue to deliver on all our strategic priorities meeting our key milestones and delivering a strong commercial launch.
as we're in the final quarter of 2025 and look to 2026, I want to reaffirm our strong confidence in our growth trajectory and the significant value creation opportunities ahead for our company and shareholders,
Commercial execution remains a top priority. The fundamentals are driving ATM map defects in your co-pack, adoption, and the launch is progressing as planned.
Our clinical pipeline continues to advance on multiple fronts.
We expect several important data readouts in the first half of 2026 that will further demonstrate the breadth of our Ras mapk pathway driven approach.
we expect to share safety and efficacy results from a ramp 205 expansion cohort in first line Advanced pancreatic cancer in the first half of 2026
We also plan to share initial results from our phase 12a trial, evaluating vs 7375 and advanced g12d mutant solid tumors in the first half of 2026.
We'll continue to advance our trial of vs 7375 in both monotherapy and combination expansion cohorts, in pancreatic lung, and colorectal cancers.
Importantly, we believe vs. 7375 has demonstrated significant investment in class potential among kres.
G12d Inhibitors to date in both Advanced pancreatic cancer and lung cancer.
And we're committed to moving quickly, to registration enabling studies in these and other high potential priority indications.
This is an active area of focus for the company and we plan to engage for the FDA in the first half of 2026 to discuss our path forward.
This would include seeking their input on how to harmonize the abundance of existing data generated by a partner in China, to advance the program efficiently on behalf of patients, who currently have no FDA approved treatments for their kras. G12d mutated cancers.
We now have a commercial product generating growing revenue and a robust clinical pipeline with multiple near-term catalysts that will determine the future development plans.
We're building a sustainable. Multi-asset oncology company to address. Important unmet needs in rasim map. K pathway driven cancers.
With that, we'll open up the calls for questions. Operator.
At this time, I would like to remind everyone in order to ask a question. Press star, then the number 1 on your telephone keypad. We will pause for just a moment to compile the Q&A roster.
Comes from the line of Michael Smith with go security. Please go ahead.
Um,
On the LG SOC launch. Um, yeah just wondering if you could provide a few more comments on how the the product is being used in the market, in terms of um, patients having had prior lines of therapy. I'm just thinking about some of the the the market dynamics around incidents of new patients. Um, you know, that that relapse versus that sort of existing prevalence pool. You know how how is the the product we utilize in that context? And what are you seeing in terms of uh, cos mutant versus wild type use
Yeah. I mean we're early in the launch and so you do end up seeing some patients with later lines of therapy. But we're also seeing patients that are, um, first recurrence and it is a mix of wild type and mutant, as well as some um, just off-label. Uh, totally. We don't have exact numbers on that again. We don't see total visibility of that through the distribution channel that goes through the Distributors as opposed to Specialty Pharmacy. And we don't always have a good view into total number of lines of therapy. I don't know Mike if you wanted to give it a little more color.
You're done. Um, I've been consistent with what you've said. We've seen a variety of patients across a range of lines of therapy. We're not always given the information about what prior therapies they've been on, but obviously, they've seen most of the classical mix of chemotherapy, AIs, and M plus or minus a Mech inhibitor. Since we're promoting just on label, the vast majority of our patients that we've seen so far are KRAS mutant LGSS.
All right, thanks. And then a question on the ramp 301, study update. Um, just curious, if you could comment on what type of analysis is, the idmc did. Was this just looking at event rates and adjusting for for event rates or did they perhaps look at additional information in terms of effect size? Um yeah any comments that would be helpful. Thanks so much.
Yeah. The great question I mean to be clear we're blinded by what the idmc did and
Um, we had put this interim analysis in place because, and we've mentioned this before, um, there wasn't perfect information on the comparators. There weren't prior studies with, um, prospectively broken out KS mutant and wild type. And, you know, we tried to keep the sample size as low as possible, but also have the ability to be able to upsize that if needed. Um, you know, I'm optimistic because um, the number of uh,
Of recommended additional patients was relatively small. So about 30, it was across both wild type, and mutant, which again, I think speaks to them being within the range. And what I was told is because the study occurred faster than POS than we had projected, there were less events than 1 normally would have had and I think part of the reason for adding a couple more patience is um there just aren't enough events yet really to draw any definitive conclusion and we want to make sure we're, you know, we have enough patience to be in the range.
Great, thanks so much and congrats again on the great quarter.
Thanks.
Your next question comes from the line of Justin zelen with btig. Please go ahead.
Thanks for taking our questions and congrats on the strong quarter. I want to ask about the nccn committee review, uh, in October, if you had heard back on a recommendation for the, uh, labels to, to be expanded to include kres wild type, uh, patience and have some follow-ups.
Um, yes, that's a great question and, um, to be clear had we heard we would have told people, uh, we don't know. Uh, we know the committee met uh we don't know the outcome of that yet.
Got it. Do, do you have an expectation on a timelines on? On, when you might, um,
Expect to hear back.
Uh, we actually don't um, you know, you know, we've heard it can be as long as early next year. Could be earlier I think different committees operate differently. We've not been given a lot of guidance, it's a um relatively opaque and what I would say secret process and they've all you know, signed ndas and things. And so as much as I would love to know, um, the outcome of the meeting, we just don't know yet.
On, uh, the commercial launch, do do you have any color on new patient starts versus patients who are refilling uh, prescriptions as far as contribution to your to your strong quarter.
Uh Matt, you want to take that 1?
Yeah sure. Uh great question. You know we we aren't providing that level of detail or specificity on new to uh RX refills. However um We are continuing to see significant new, uh, prescriptions come in for patients and patients that have started on therapy. Particularly in the beginning of the third quarter have uh continued to receive refills. So we are seeing that dynamic in the marketplace but providing that level of granularity at this point is a bit too premature for us. We want to just see another full quarter or 2, underneath our Bells before we provide that level of detail.
Thanks.
again, if you would like to ask a question, please press star 1 on your telephone keypad,
Your next question comes from the line of Shun Lee with HC. Wayne Right, please go ahead.
Uh, hey, good morning, guys. Um, congrats on a good quarter and, uh, thanks for taking my questions. Uh, I just have two quick ones. Uh, first, on the LG's OC market, I was wondering whether you could provide some details on, um, what you are seeing in terms of, uh, patient retention. Correct me if I'm wrong, I think I'm going to...
Study, uh, the average reading duration is about 10 months, so it's still a little bit early for that. Maybe, you know, if you provide some color on, you know, uh, the patient Dropout rates has swept in uh, in line with what you expect.
Yeah, I would say it's really early to tell, and actually, the average duration was about 18 months in the clinical trial. I don't know, Matt or Mike, if you want to provide any more color. It is really too early to tell, but.
Yeah. I mean it's a great question dian's right? The the performance of the copac in the clinical program, the door was around 18 months. Um we're seeing patients that are coming in at first recurrence and so we would expect if they're coming in at an earlier line of treatment that the benefit would be prolonged, but it is still fairly early to provide specific commentary.
Okay, I see ya, thanks for that. Um, uh my second question is on the uh the vs 7375 study, I was wondering whether there are any um significant differences between how your uh treating the patients compared to the uh, a study that you are Partners running in China. Because I think I recall that you were discussing some, um, prophylactic any Medics and such uh, is are there any notable differences?
Yes. And thanks Sean. It was a great question. Um, yeah, 1 of the things that we've said we were doing differently is and this was based on experience with the g12c Inhibitors, um, being developed. And a number of our investigators participated. In those studies is really the difference is where um the patients in China were fasted. Um, this first couple of cohorts, we treated in the US were fed. Uh, they were also, um, mandated to have prophylactic anti, which is not a part of the protocol in China. And part of the reason we, um, you know, released the information on the first 2 cohorts is a, you know, we thought it was important that we cleared those first 2 cohorts, which included the recommended Phase 2 dose in China, without any dlts, but also the early data that we're seeing is that those interventions are making a difference. And, um, as um, we said earlier, uh, we didn't see any, um, GI toxicities. You know. Nausea, vomiting diarrhea that were graded in grade 1, which we were
A very happy to see and we hope that carries forward.
And great. Uh, thanks for that. And that's all the questions I have.
Great. Thanks. Sean.
Your next question comes from the line of unz with B Riley Securities. Go ahead.
Congratulations on the commercial launch and maybe my first question is for your confirmatory trial. Can you remind us what was the enrollment plan for the kirat mutant patient population and kirat well type patient population separately?
Quite a bit and that it was both arms which you know, tells us that um you know we're in play with both of them.
Is what is your next step or priority in the commercial launch? Uh, do you plan to Target more prescribers or just make sure a higher number of prescription products?
I would say both, you know, we're we're not going to change what we're doing. We feel that between our direct calling on individual, doctors to Pro programmatic work. We're doing with the organizations and our digital work as well as um reaching out to patients that we're covering the Waterfront. So we're not planning on changing what we're doing but it's really a matter of making sure existing prescribers continue to prescribe
New prescribers, come on because in any launch, you've got early adopters, mid adopters late adopters and we're working through that chain and then importantly that when patients go on they stay on.
Maybe before I come back to the queue. My last question is on the patient's Journey. So let's say a patient, got their prescription, how long do they have to refill? And how often do they have to visit the doctors to check? You know either symptoms or any side effects additional color will be very helpful. Thank you.
Yeah Mike, do you want to take that 1?
Sure, so um, prescription is for a month's Supply, 3 weeks out to 4. Um, and in terms of doctor's visits, there is a small amount of visit to begin with just to make sure they're being monitored closely for early toxicities, but that rapidly goes down to every 3 to 6 months.
Thank you.
Your next question comes from the line of Eric Schmidt with cater Fitzgerald, please go ahead.
thanks for taking my question and and apologies, I, I hopped on a little bit late but with regard to, the ramp 301, idmc recommendation to to moderately upsize the study, can you talk about
What the potential outcomes could have been through that look and and what data uh, the committee had access to order to make the decision. Thank you.
Yes. So the committee had the full data set and the outcomes could arranged from everything from futility.
Adding um, I believe up to a 100 patients. Um, to they could have added none. Um, you know again we're blinded to the actual results but our understanding was um, there were less events than 1 would have anticipated given the rapid approval and that may, you know, led to the small number of patients being added on. But they are being added on to both krest, wild type and mutant, and it's about 30 across the 2.
Groups.
So that's helpful. Thank you. Um there wasn't any pre-specified criteria for adding the the 30-ish 27 patients. It was sorry. 29 patients. It was just what the idmc chose to do that number.
Um my understanding is it was within their purview and they made a recommendation to us and we followed it and again it, you know, we don't have full transparency into exactly what they were doing.
And then maybe switching to the um uh 7675 the g12d and your ongoing uh study. They're very clear that GI tolerability was good in the first dose with no um more than a great 1 cases of uh GI issues were there.
Any other side effects to report in that initial cohort, any anything at all a great 2 or 3?
Um, I I, well, I believe there were some grade 2, or 3 um, in, you know, very, very small numbers but nothing no signal that we had not expected based on the Chinese data, I think. The only thing that was really different was, um, you know, the level of ghee talks and we'll give a more full release of the full efficacy. Once we've got a few more patients on it. I think we've got it. Um, you know, early next year. We'll give an update on both efficacy and safety.
Great, thank you, Dan.
Thank you, Eric.
Your next question comes from the line of James Malloy with Alliance Global Partners. Please go ahead.
Hey guys, thank you very much for taking my questions. I was wondering, could you share any Savannah total, uh, updates from uh, from the launch uh, talking to, uh, the usage and the potential offer level usage on uh on the wild type versus mutant uh, and sort of any feedback you're getting early stages of the launch. And then I have a couple of other questions as well.
Give a little more color.
Sure. I mean I think as we shared in our um scripted remarks, and an earlier question, um we're promoting obviously our labeled indication. So the vast majority of use we've seen thus far, has been within the kras mutant LG SOC population. That doesn't mean there haven't been more time patients because they have. Um, and those have also been seen seen coverage through the payers as well, thus far.
Okay, great. Then maybe before this look like, there's been some, uh, Mna in the oncology space recently. Um, you know, he has an office after after, after an excellent launch here, any thoughts, I can discuss any any in interest you make because may may not have or from other partners.
Yeah, I mean, obviously we wouldn't talk about any specifics but, um, you know, given you know, the launch trajectory to date and I, you know, say even more. So the excitement around g12d and how, um, the molecules performed both free clinically and clinically, um, we do get a fair amount of inbound interest in, um, you know, entertain those discussions all the time. Um, you know, we've got some very exciting plans to take these forward, but we're always evaluating, um, could we do more with more resources?
Okay, thank you for taking questions.
Ladies and gentlemen, that concludes today's call, thank you all for joining. You may now disconnect