Verastem Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: We secured FDA approval for our lead therapy, AvmapKefaxin co-pack, for KRAS-mutated recurrent LGSOC nearly two months ahead of schedule, marking the first-ever novel drug combination approved in oncology.
  • Positive Sentiment: In the first six weeks of commercial availability, AvmapKefaxin co-pack generated $2.1 million in net product revenue, reflecting strong early market uptake and seamless payer coverage.
  • Negative Sentiment: R&D expenses rose to $24.8 million and SG&A to $20.7 million, driving a non-GAAP net loss of $41.4 million compared to $16.5 million a year ago.
  • Positive Sentiment: The balance sheet was bolstered by a private placement, ending Q2 with $164.3 million in cash and investments, supporting operations into 2026.
  • Neutral Sentiment: Multiple clinical trials remain on track, including the VS7375 G12D inhibitor and the Phase 3 RAMP-301 study, with key data readouts expected later this year.
AI Generated. May Contain Errors.
Earnings Conference Call
Verastem Q2 2025
00:00 / 00:00

Transcript Sections

Skip to Participants
Operator

Thank you for standing by. My name is Rebecca, and I will be your conference operator today. At this time, I would like to welcome everyone to the Verastem Oncology Second Quarter twenty twenty five Financial Results Conference Call. All lines have been placed on mute Call. Thank you.

Operator

I will now turn the call over to Drulissa Fianna, Vice President, Corporate Communications, Investor Relations, Patient Advocacy. Please go ahead.

Julissa Viana
Julissa Viana
VP, Corporate Communications & IR at Verastem

Thank you, operator. Welcome, everyone, and thank you for joining us today to discuss VeriCEM's second quarter twenty twenty five financial results and recent business updates. Earlier today, we issued a press release detailing our financial results for the 2025. This release, along with a 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.

Julissa Viana
Julissa Viana
VP, Corporate Communications & IR at Verastem

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 of the company's most recent annual report on Form 10 ks filed with the SEC on 03/20/2025, and the current report on Form 10 Q filed today as well as other reports filed with the SEC. Any forward looking statements we make represent Verastem's 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 VeriStem, who will provide opening remarks and recap key highlights from the quarter Matt Ross, Chief Operating Officer and Mike Crowther, Chief Commercial Officer, who will walk through the initial progress of the Avmazky Faxinga Copac commercial launch and Dan Calkins, Chief Financial Officer, who will provide an overview of our financial results. I will now turn the call over to Dan.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Thanks, Melissa. Good afternoon everyone and thank you for joining us on today's call. We're pleased to report that we delivered exceptional results in the 2025 highlighted by a particularly transformative second quarter. Our team achieved several significant milestones that position us for sustained long term growth. We secured FDA approval for our lead program ahead of schedule and successfully launched Abnapti Faxinga Copac marking a major inflection point for the company.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

In addition, we advanced key clinical programs and strengthened our balance sheet to support our growth. As we look ahead to the 2025, we remain highly focused on maintaining this strong momentum, bringing our new treatment option to more patients and delivering value for our shareholders. The second quarter marked a pivotal milestone for our company with the FDA approval of AvmapKefaxin Jakobak for KRAS mutated recurrent LGSOC. This approval represents several industry firsts that underscore the significance of our achievement. For the first time patients with this rare ovarian cancer have access to an FDA approved therapy specifically to address this area of high unmet need.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

And to our knowledge this approval marks the first ever truly novel novel drug combination approved in oncology, a clear validation to our innovative approach and execution capabilities. Importantly, we received accelerated approval nearly two months ahead of schedule and our extensive pre launch efforts over the last two years allowed us to quickly move into the market. Avmap defects in Jakobak was available at our designated specialty pharmacies within five days of approval demonstrating our operational excellence and commitment to patient access. In just six weeks on the market, we reported $2,100,000 in net product revenue reflecting successful early traction and robust execution across all key launch priorities. Our commercial and medical teams have performed exceptionally well in engaging healthcare providers, supporting patients, and ensuring seamless access, delivering on each component of our go to market plan.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Matt and Mike will speak more about this in a few minutes. As we continue to build on the positive momentum thus far, we firmly believe that the Abmap diffaxinga co pack will become the new standard of care for this indication, fundamentally changing the treatment paradigm for this disease. I'll now turn the call over to Matt to discuss our commercial launch in greater detail. Matt?

Matthew Ros
Matthew Ros
COO at Verastem

Thank you, Dan. The entire team is proud to bring this novel and breakthrough therapy to people living with KRAS mutated recurrent LGSOC, and we are encouraged by our early launch progress. This therapy addresses a critical need in LGSOC as patients face poor response rates to chemotherapy and hormone therapy, which results in high recurrence rates, creating an urgent need for more effective treatment options. As the first ever treatment approved specifically for KRAS mutated recurrent LGSOC, we can make a real difference in patients' lives. Our launch strategy focuses on three key areas.

Matthew Ros
Matthew Ros
COO at Verastem

First, we want to reach all healthcare providers. We are effectively targeting both academic and community based physicians. Our experienced field and marketing teams are executing at a high level, ensuring healthcare providers understand unique benefits and how to safely use AppMAPI Faxingia Copac. We're supporting these efforts with comprehensive and complementary digital marketing efforts. Second, we want to engage and support patients.

Matthew Ros
Matthew Ros
COO at Verastem

Given the very limited treatment options available, many patients will continue to progress through other therapies and will likely be ready for a new treatment option within six to seven months. We are building upon our patient advocacy relationships and using various tools to educate patients and their caregivers about this new treatment option and supporting conversations with their doctors. And third, we want to ensure seamless access by providing comprehensive patient support for access to epmask effects and to co pack. We have seen coverage from the largest insurers in The US, including the three major PBMs, representing over eighty percent of lives in The US. We're working closely with payers to establish appropriate coverage policies.

Matthew Ros
Matthew Ros
COO at Verastem

I'm proud of what the team has accomplished since our May approval. The approval came early and the team hit the ground running and is executing well against all three areas of the launch. As Jan said, we achieved $2,100,000 in net product revenue in the first six weeks of launch. To date, reimbursement has not been a barrier to access. While it is too early to share any trends or provide guidance on future prescriptions, we are encouraged by what we are seeing.

Matthew Ros
Matthew Ros
COO at Verastem

Consistent with expectations, we have seen a variety of patient usage. Specifically, the combination therapy has been prescribed to women with advanced disease who have tried more than three prior lines of therapy. Encouragingly, we have also seen prescriptions for patients who were experiencing their first recurrence. This matches our pre launch market research and the types of patients enrolled in Ramp two zero one. Our sales force has been highly effective in engaging with physicians across academic, community centers, and large private oncology practices.

Matthew Ros
Matthew Ros
COO at Verastem

Early use of epmap defects in Jakobak appears to be well balanced between these customer segments. Physician enthusiasm has been very high. In fact, some customers are reaching out to us to help educate their entire treatment teams on the therapy, including some accounts that are historically viewed as hard to access or not known to grant access to sales representatives. In addition to our sales force efforts, our medical science liaisons are contributing to the more fulsome understanding of FMAP defects in Jakobak and LGSOCC through impactful scientific exchanges with opinion leaders. We expect the recent RAMP-two zero one and FRAME publications to drive an even deeper appreciation and understanding of the clinical relevance of FMAP defects in Jakobak.

Matthew Ros
Matthew Ros
COO at Verastem

These studies show the combination therapy's clinically meaningful response rates, duration of treatment, long progression free survival, favorable tolerability profile, and low treatment discontinuation rates. Moving to physician and patient education, we launched a comprehensive physician education and digital patient engagement effort immediately after approval. Our branded websites for HCPs and patients are seeing high engagement, showing we are a trusted source of information. We quickly activated our distribution network by bringing on two independent oncology focused pharmacy to fulfill prescriptions as soon as possible. Together with the Verastem Cares patient support program, these pharmacies also provide comprehensive patient support services. Recently, we have entered into multiple agreements with specialty distributors and oncology group purchasing organizations. Looking towards the second half of the year, we will build on this momentum while staying laser focused on our strategic imperatives. Given our early achievements, our team's effective execution, and the high unmet need for this rare form of ovarian cancer, we believe we are poised to have a strong second half of the year. Now, I will turn the call over to Mike.

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

Thanks, Mark. It's a pleasure to be on the call today and provide some further details on the launch of the Avmac Defaxinger co pack. As you have heard, we are off to a strong start that began with our commercial team engaging prescribers immediately after we learned of the approval. The team has been incredibly nimble in a short period of time and we are proud to be making a positive difference in the lives of people living with LGSOC. Now let me share some early indicators in the launch dynamics.

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

In the second quarter, with just six weeks in the market, our field team called on 93% of the top 100 parent organizations and 84% of the top 100 office locations. We know that HCPs who treat LGSOP have a good understanding of where the patients are on their treatment journey. We are hearing from them that they are actively assessing identifying patients when they might become appropriate candidates for the combination therapy. We are seeing prescriptions to patients coming from these high priority accounts including a mix of academic and community. We are also starting to see both repeat prescriptions from physicians prescribing to multiple patients and refills for individual patients as patients receive their treatment package within a short timeframe following the receipt of a prescription for at one of the specialty pharmacies.

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

Our medical science liaisons and oncology nurse educators have been equally busy, having engaged in hundreds of scientific exchanges and over 30 educational forums with healthcare providers in the quarter. Feedback from customers has been very positive regarding the product profile and our Veris M Care support program. It's early days, but the breadth and reach of our field engagement is critical as we raise awareness of the availability of a first ever treatment specifically for KRAS mutated recurrent LGSOC patients. Importantly, immediately after abutamestine defactinib was approved by the FDA in May, we were immediately listed in the NCCN treatment guidelines with CASPI-2A recommendation, which is aligned with the approved indication. We recently submitted the Ramp two zero one and FRAME publication to the NCCN to potentially expand the recommendation to include the broader LGSOC population that was enrolled and represented in both studies.

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

The NCCN committee has informed us that they plan to review our submission in October at our annual meeting. Additionally, these recent important publications are appearing in high impact journals, which will help us to further increase awareness and understanding among physicians and medical professionals about our product and the disease state that it treats. As Matt mentioned, we activated our digital programming and branded websites quickly to engage and support patients looking for information on the combination therapy. We also engaged with the 2,500 patients who previously signed up on our disease education website before the launch. As we have shared previously, the general payer mix for our combination therapy is about half commercial and half Medicare.

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

While it's too early to break down the mix we have seen to date, thanks to the process we have in place, the payer coverage has been broad and the time to fill prescriptions has been fast. While this process will evolve and formulary coverage will build over time, we believe payers are acknowledging the unmet needs that can now be addressed by Admiral Q factor in the co pack as well as the clinical value of the combination therapy. To close, we strongly believe that Abnath Q factor 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. I'm happy with our results against our strategic imperatives in these early days and the team is executing well against all our launch objectives. We believe a steady adoption will occur over time and our early observations post our approval support this perspective.

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

I look forward to sharing more in the coming quarters as we progress through the launch and gain more experience and insight. With that, I'll turn the call over to Dan.

Dan Calkins
Dan Calkins
CFO at Verastem

Thank you, Mike. Since we issued a press release before the call today with the full financial results, I will focus on the highlights as shown on the next slide. We performed well in our initial quarter of launch, and I am pleased to report $2,100,000 in net product revenue for the first six weeks with six weeks of the launch. Cost of sales were $400,000 for the 2025 versus zero in the 2024. Cost of sales did not include a significant amount of product costs as inventory produced prior to FDA approval was fully expensed at the time of production.

Dan Calkins
Dan Calkins
CFO at Verastem

Research and development expense were 24,800,000 for the 2025 compared to $18,100,000 for the 2024. The increase was primarily driven by higher clinical related expenses to support the global phase three RAMP-three zero one trial, higher drug production activities in preparation for the launch, and higher costs associated with drug product and startup activities related to the BS7375 phase 128 clinical trial in The US. Selling, general and administrative expenses, or SG and A, were $20,700,000 for the 2025 compared to $10,200,000 for the 2024. The increase was primarily driven by commercial readiness activities and operations, including personnel related costs, in preparation of the approval. With that being said, we continue to be prudent in our expense management.

Dan Calkins
Dan Calkins
CFO at Verastem

For the 2025, non GAAP adjusted net loss was $41,400,000 or $0.63 per share diluted compared to non GAAP adjusted net loss of $16,500,000 or $0.61 per share diluted for the twenty twenty four quarter. Please see our press release for a reconciliation of GAAP to non GAAP measures. Moving to the balance sheet. We strengthened our financial position in April with a $75,000,000 private placement, which included issuance of common stock and pre funded warrants. We ended the 2025 with cash, cash equivalents and investments of $164,300,000 We believe our current cash combined with future revenues from FMAPI PEPF Synergy co pack sales and the exercise of the outstanding cash warrants provides cash runway into the 2026.

Dan Calkins
Dan Calkins
CFO at Verastem

This is an exciting time for all of us at Verastem as we start delivering the AvMazk effect synger co pack combination therapy to patients in The US. We had a solid first quarter as a commercial company, and we have sufficient capital to fund our ongoing commercial launch in The U. S. And continue advancing our current clinical development plans. With that, let me turn the call back over to Dan.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Thanks, Dan. Before we open the call to Q and A, I'll share a few final remarks to close out today's presentation. It's been a strong first half of the year for Verisem, and we've delivered on all of our milestones and are off to a great start with the commercial launch. We're in a strong position to continue executing against our plan. For the second half of the year, some of our milestones include continuing to report on the launch of AvMaFK effects in Jakobak.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

We're advancing our potential best in class oral G12D on off inhibitor, VS7375, which our partner Jenfleet shared encouraging early results at ASCO from our study in China. We'll continue enrollment in the VS7375-one 101 trial including the monotherapy portion and move towards initiating the dose escalation combination cohort of VS7375 in combination with ceftuximab in the fourth quarter. In our Ramp two zero five frontline metastatic pancreatic cancer trial, we demonstrated an eighty three percent response rate with ten of twelve patients achieving a confirmed partial response. We have moved quickly to enroll additional patients into an expansion cohort and will complete enrollment in the third quarter. In our Ramp two zero three KRAS G12C advanced non small cell lung cancer trial, we plan to share an interim safety and efficacy update in the fourth quarter.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Finally, we expect to complete planned enrollment in our phase three RAMP-three zero one trial evaluating the combination in recurrent low grade serous ovarian cancer regardless of KRAS mutation status. These milestones demonstrate the breadth of our development programs and our commitment to maximizing the potential of our platform across multiple cancer types. We have tremendous momentum heading into the second half of the year and remain confident in our ability to execute against our strategic plan and continue to help the patients we serve. With that, we'll open up the call for questions. Operator?

Operator

Your first question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Paul Jeng
Vice President at Guggenheim Partners

Hey guys, thanks for taking our questions. This is Paul on for Michael. So just on the LGSOC launch, can you talk about the degree of off label use that you're currently seeing in the ARREST wall type setting, what the feedback has been from providers on intended use in this setting? And then what you expect in terms of prescribing and reimbursement trends leading up to the possible NCCN guideline update in October and how that could inflect once the decision is made on including the full data set?

Matthew Ros
Matthew Ros
COO at Verastem

Sure. Thanks for the question. This is Matt. While we don't promote any off label uses, of course, based on the current label, we have seen utilization in both the labeled population as well as in the wild type population. Reimbursement for the patient populations that we just spoke of have not been an issue to date and we'll continue to follow the reimbursement patterns as we move forward into the third quarter leading up to NCCN.

Paul Jeng
Vice President at Guggenheim Partners

Great. And then I have a follow-up on the KRAS program. So it seems like The U. S. Study is enrolling fairly well.

Paul Jeng
Vice President at Guggenheim Partners

Can you just talk about the scope of that update in the fourth quarter? Will it be roughly the same number of patients following TDAC as the initial China study update at ASCO? And also, could we expect any additional updates from GENFLEET from that China study at some point? Thank you.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Sure. Thanks for the question. This is Dan. We would expect the magnitude of the update that we'll give to be roughly equivalent to what we saw in the Chinese data at ASCO. Genfleet has advised that they'll be presenting additional data at two different medical meetings later this year.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

So you should expect two updates from Genfleet and then we'll give an initial update on our Phase one experience in The U. S. Likely late this year on the safety side and there's a lot of interest in that and then the efficacy early next year.

Paul Jeng
Vice President at Guggenheim Partners

Got it. Thanks very much.

Operator

Your next question comes from the line of Kelly Hsu with Jefferies. Your line is open.

Analyst

This is Anshi on for Kelly Hsu. Congrats for the quarter and thanks for taking our question. Our question is, what are the key indicators you're tracking to gauge the launch performance? And how should we interpret those in terms of launch momentum in the back half of the year? And what could be the key drivers there? Thank you.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Yes. As it's early in the launch and as Matt had mentioned earlier, we launched with the two specialty pharmacies in place. We've now brought on the specialty distributors and the GPOs. And so we're just starting to track the breadth of data that we're able to get. I'll let Matt comment a little more kind of where we'll go from here.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

But part of it is really starting to see the patterns we see and see what we think is repeatable and reliable. And that'll then inform kind of what we're going to be tracking. But Matt, I don't know if you want Yes.

Matthew Ros
Matthew Ros
COO at Verastem

No, I mean, Dan is absolutely right on that. I mean, we've mentioned on the call the importance of the three strategic imperatives around engagement with the healthcare community, ensuring that patient access continues to be seamless and that we're working closely with the patient population. So you can expect, I think over time and once we see the appropriate trends that the reporting on our performance will be anchored against those three imperatives.

Analyst

Got it. Thank you.

Operator

Your next question comes from Pete Stavropoulos with Cantor Fitzgerald. Your line is open.

Pete Stavropoulos
Director - Biotech Equity Research at Cantor Fitzgerald

Hi, Dan and team. Congratulations And thank you for taking our questions. First one, in terms of prescribers, do you have a sense if these are physicians you were targeting? What is the split between centers of excellence and community setting?

Pete Stavropoulos
Director - Biotech Equity Research at Cantor Fitzgerald

And can you provide some color on how this traction sort of compares to your expectations?

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Yes, I'll start and then I'll hand it over to Mike. I would say, probably exceeds our expectations. We had a lot of inbound and I know Mike in the sales force doesn't like to hear this, but we actually had prescriptions from people hadn't been called on yet. But we did, it was a nice mix of the high priority sites and really ones that we hadn't expected and we actually have a couple of physicians that have had multiple prescriptions that weren't on our high priority list. And so, the team is working really hard with the larger centers to really compile lists of patients.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

I've said a number of times as we've been asked, will be the is there going be a huge bolus of patients that are just sitting out there. The nature of this disease is they need to be treated. And so and we wouldn't advise anything different by the way. If you're on a therapy and it's okay, this is a marathon not a sprint. And the best thing for the patients is to stay on what you're on as long as you can tolerate it and as long as the cancer isn't advancing.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

And at the point in time either of those things happen, then there's a conversation with the physician. And based on our market research and what we're seeing so far that is what's happening. They come in, they talk and we've been told where the most likely thing they'll go on next. And so, it's probably too early to give numbers on the actual breakdown, but we are seeing the majority of scripts I would say are from Gyn oncs. And that's not a surprise.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

The big volume would go to them. We are seeing it from med oncs. And it's rolling out kind of as we'd expected qualitatively, quantitatively, I'd say a little ahead of where we thought we would be. I don't know if Mike, if you Sure. Want to say anything

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

I'm just trying add a little bit more color and thank you, Dan, thank you for the question. You can imagine we're very encouraged by the breadth of the initial uptake. We've certainly seen a lot of business from the top one and two tier customers that represent about 50% of the potential. But obviously about 50% are managed more broadly across the reach. And we've seen encouraging uptake outside those from both community and academic physician.

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

We've obviously got a very focused field strategy and we're going to continue broadening the reach of that in Q3. But we do now expect the business to continue evolving because we put in place those critical GPO agreements in SD contracts as well. So I think overall, we're not surprised by the business from our center accounts, but we're very encouraged by the spontaneous use arising from those accounts, which we're supporting through our digital outreach and surround sound activities as well.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Yes. And an important point that Mike just made, because the approval became came almost two months early, there were certain things we could accelerate. We hired the sales force. We were ready to go with our specialty pharmacies. We wanted to make sure that in the early days of the launch, this was very high touch.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

And so this is all through specialty pharmas. Now we're bringing on the specialty distributors that are aligned with the GPOs. A big part of our strategy to reach the physicians in those large practices is not to expend a lot of effort trying to go one on one to those physicians, because frankly those practices don't like sales reps anyway. It's really the educational programs through the GPOs that we're just bringing online now. So we had no impact to that whatsoever in the first quarter.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

And so I really feel like we're going into the second half of the year with kind of all of our sales up, the winds at our back and we'll start to see the effect of everything that we were planning to bring to bear for the launch.

Pete Stavropoulos
Director - Biotech Equity Research at Cantor Fitzgerald

All right. Thank you for that color and that detail. Just one more question. Just curious to know what your experience has been with payers, any pushback or perhaps you're still in the honeymoon phase with them? Any thoughts around that would be great.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Yes, I would say, my market access people tell me that there's always a honeymoon phase at the beginning. Now having said that, we're not exactly Wegovy and I don't expect that there'll be a massive pushback from payers, because frankly, we have the data packets to support the reimbursement. And so and this is kudos to our specialty pharmacies to date. They've done a phenomenal job. And we've seen reimbursement both with mutant, with wild type, with totally off label uses, which again, we wouldn't promote.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

But we're finding that the data really supports the usage of these drugs and so far so good. We're seeing it's prior off, of course. Medicare in particular in that first ninety days, you get the first denial and then you have to put the appeal in. But we're seeing very short periods of time indicated by the fact that we're giving away very little free drug. We're not discounting.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

And I would say the most impactful program to date has been our $0 copay, because we are committed to minimizing the burden on patients and we are making sure that patients don't have to pay a lot out of pocket for this. That's obviously on the commercial side. The benefit of IRA on the Medicare side is those patients are now capped at 2,000 out of pocket total cost. So that should have minimal impact. So early days so far so good.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

We're hoping to continue that And looking forward to a great second half of the year.

Pete Stavropoulos
Director - Biotech Equity Research at Cantor Fitzgerald

All right. Thank you for taking my questions. And once again, Great to see you moving forward.

Sean Lee
VP - Equity Research at H.C. Wainwright & Co.

Thanks Pete.

Operator

Your next question comes from the line of Leonid Timmasheev with RBC Capital Markets. Your line is open.

Anish Nikhanj
Anish Nikhanj
Senior Associate - Biotechnology Equity Research at RBC Capital Markets

Hey guys, it's Anish on for Leo. Congrats on the progress this quarter and for taking our questions. Just a couple from us. First, how might the launch curve for AvFac evolve as you switch over from specialty pharmacies to the integration of the specialty distributors you mentioned? And second, even though it's early, it would be great to get a sense on the breakdowns of AVFACT patient history based on lines of care and recurrence, if you could share some color there? Thanks so much.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Sure. I would say in general, I really feel like because this came early, we didn't have the publications and we had part of our distribution network in place. That first six weeks, we kind of had a hand tied behind our back. And I really do feel like a lot of the pre work we've done, we've been out doing outreach with our MSLs for the last two plus years. I think when we have the full complement in place, we really should see an acceleration.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Again, I don't think there's a huge bolus of patients sitting there. This will be a steady uptick. But what we will start to see is the benefit of the long duration of therapy. And we would expect over time that you're going to see a big group of patients who are continuing patients and then adding more on every month. And as far as the mix, I don't know Matt if you want to say anything or Mike? Yes.

Matthew Ros
Matthew Ros
COO at Verastem

It's a little early, but Yes. It is a little early. We're following it as closely as you might expect us to be doing. We've seen a mix of patients with multiple lines of prior therapy, but also encouragingly, we've seen patients that have the combination right at their first recurrence, which is quite consistent with our market research that was conducted in the pre launch setting and remarkably consistent with what we observed in ramp 02/2001. So the dynamics of 02/2001 and what we've seen in our market research, as I just shared is lining up, and it's been very consistent within the six first weeks of the quarter and we're seeing those trends continue into the third. Yes.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

And there have been a couple of KOLs who expressed the interest in us wanting to go to frontline and we started investigator sponsored trial in frontline in combination with AI. We're looking into kind of more substantial programs there. Obviously, an eye on cost, but there's great enthusiasm around the drug combination and we want to continue to build on that.

Anish Nikhanj
Anish Nikhanj
Senior Associate - Biotechnology Equity Research at RBC Capital Markets

Thanks and congrats again.

Operator

Your next question comes from the line of Craig Svanov with Mizuho. Your line is open.

Graig Suvannavejh
Graig Suvannavejh
Managing Director at Mizuho Financial Group

Great. Thanks so much for taking my questions. Congratulations on the launch so far. Wanted to ask two questions if I could. First, just on the launch, could you just remind us, even though there was a question already on kind of how you think the uptake curve could look like, could you just remember remind us of your commercial efforts in terms of sizing, how you expect that may or may not evolve over time?

Graig Suvannavejh
Graig Suvannavejh
Managing Director at Mizuho Financial Group

And then secondly and with that, if you could comment on the role of IQVIA in that. And then secondly, on the NCCN guideline potential inclusion in the meeting in October, could you maybe provide some color, for me at least, as to, typically what types of considerations go into, the committee that reviews this stuff? You know, are there certain criteria that they need to see? I guess what I'm trying to get at is trying to get a sense of how we should think about the level of confidence that you will get inclusion, although I think most people think that you will. But any color there would be great. Thanks.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Yeah, why don't I start with the NCCN one and then Mike, I'll turn it over to you. I mean, they look at the totality of the data. And if you look at the publications, I think anyone who's looked at the publications feels that these patients benefit. And as much as I would have liked, we got the 2A on the label right away and that was kind of administrative e mail back and forth. As much as I would have liked the other part sooner, I think it's important to understand that in these committees, not everyone is an LGSOC expert.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

They're ovarian experts, but there's a handful of the LGSOC experts that are on the committee. And I think having them in a room together with our publication to advocate is our best chance of getting it done. And we have heard universally that there's the belief that this benefits patients broadly and we think that would factor into the decision, although nothing's guaranteed and we're not going to be in the room. It's not like an FDA meeting where we get to go and advocate for ourselves. We're relying on the LGSOC experts to advocate for us at those meetings.

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

And to address the shape of the curve and the evolution of the launch, I think, as we said, we're very encouraged by the strength at the start. And we continue to believe that we'll continue to see steady progression because this is not a switch market where we anticipate seeing a large bolus of patients. Obviously, bringing the STs and the GPOs online for the Q3 and Q4 and putting those additional programs in place that Dan spoke to, I think will continue to give us increasing breadth and opportunity to push on that. In terms of the evolution of our commercial organization, we held the premise that we would focus very heavily through our field teams on the top 100 accounts. And we've seen such positive results from that.

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

I don't see any initial reason to adjust that strategy. But we'll keep a weather eye to make sure that the reach and frequency is what we'd expect. And then obviously, we're supporting that through the digital programming and the GPO programming. Again, Dan spoke to the other 50% of patients managed through those large community practices. And we also obviously have a very strong medical

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

We're continuing to engage at medical meetings and others to catch those customers increase our frequency of connection with those customers.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

And as for the IQVIA relationship, a small biotech launching a drug, the ability to be able to tap into these world class resources in an era where digital matters, data matters. We never could have gotten data warehouse and all the infrastructure up two months early without a partner like IQVIA that was tapping into infrastructure they had and essentially customizing stuff for our business rules, but not building from scratch. And so we've been very pleased with that relationship. They work nights and weekends just like our team and beside our team as we were getting ready to do this. And that's the reason we were able to pull this off.

Graig Suvannavejh
Graig Suvannavejh
Managing Director at Mizuho Financial Group

Thank you. Congratulations again.

Operator

Your next question comes from the line of Justin Ziehlen with BTIG. Your line is open.

Justin Zelin
Director - Biotechnology at BTIG

Thanks for taking our questions and congrats on the successful launch thus far. So given your use of specialty pharmacy, can we assume the $2,100,000 in Q2 revenue largely reflects true patient demand with minimal channel stocking? And can you just talk about expectation of any inventory channel stocking moving forward? And if you could share any early insights on gross to net dynamics or how the payer mix is shaping up between commercial and Medicare?

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Sure. I'll take part of that and then I'll hand it over to Dan C. So thank you for the question. I'm surprised we didn't get it earlier. Because it was just two SPs, there was minimal stocking.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

We've been pretty adamant in our agreements that we get to limit the inventory. We want to make sure that we don't have any surprises with returns and things like that. And so we're keeping tight control. I will tell you each of the SPs has been restocked a number of times and that just shows that the inventory is going out the door. This isn't a bunch of inventory sitting on shelves. Dan, I'll let you speak to gross to net.

Dan Calkins
Dan Calkins
CFO at Verastem

Yes. So yes, thanks, Justin. Obviously, it's early in the launch and we're getting everything up and running. So we've been given the specifics on the gross to nets and when that will be going forward. But I think as we look forward, if you look at other oncology small molecule therapeutics, I think typically it's around fifteen percent to twenty percent, which is not a bad expectation.

Dan Calkins
Dan Calkins
CFO at Verastem

So we'll continue to monitor that, but we're not giving the specific guidance or details of that at this point.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Any follow ons or are we going to move to the next question?

Operator

Your next question comes from the line of Sean Lee with H. C. Wainwright. Your line is open.

Sean Lee
VP - Equity Research at H.C. Wainwright & Co.

Hey, good afternoon and congrats on a great quarter. And I just have two quick questions. First, you mentioned that most of these patients are switching on once they progress from their prior therapy. So I was wondering, have you noticed any noticeable differences between these patients versus what patients you've had in the clinical study?

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

No, I think as Matt said earlier, it aligns pretty well with what we saw in the study. In the Ramp two zero one study, we had patients from one to 10 prior lines of therapy. And we are seeing a mix of patients who had multiple prior lines as well as ones that are coming right off their first relapse. And they typically come off therapy for two reasons, either progression or they can't tolerate their existing therapy. And again, consistent with what we saw with the patients that went on RHAM-two zero one.

Sean Lee
VP - Equity Research at H.C. Wainwright & Co.

Great, thanks for that. My last question is on the 07/1975 study. So I was wondering, how quickly do you expect to move on to specific indications because generally it has quite a bit of safety data to back it up.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Yes, no, that's a good question. So the reason we were able to start the trial at four hundred milligrams, which is clearly right in an effective range is we included the Chinese data in our IND. And so that probably cut, I don't know, six to nine months off the timeframe because we didn't have to start back at the lower doses. So we intend to move very quickly. What we're finding is there are a lot of these patients out there and the sites we've chosen not only have a lot of patients, but they're very experienced investigators.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

We're finding, we open a cohort, the cohort gets filled. And so we're going to move very quickly. Once we get to the six hundred milligram dose, we're going to start the cetuximab combo early. And again, that I think was benefited from having some human clinical data in the IND and allowing us to really short circuit a lot of this. And so we intend to move very quickly.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

We believe that we have a best in class drug. We're excited to be able to get data out as soon as possible. There will be additional data from the Genfleet experience at least two meetings later this year. So we're looking forward to getting a lot more out there to really back up what we've been saying about the drug.

Sean Lee
VP - Equity Research at H.C. Wainwright & Co.

Great, thank you. Thanks for that. That's all I have. Great, thanks.

Operator

Your next question comes from the line of Yong Jai with B. Riley Securities. Your line is open.

Yuan Zhi
Managing Director at B.Riley Securities

Thank you for taking our questions and congrats on this initial commercial ramp up. When we think about modeling for 3Q and 4Q, should the free sample play an important role in this initial ramp up and in the 2Q, do you know how many free samples were used by patients?

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

To be clear, there aren't free samples as a means of bridging over until insurance gets approved. We can give a month's supply. I mentioned a little earlier, there's been almost none. It's been very little and really the program that we've used the most is really the co pay assistance and we're happy to do that.

Yuan Zhi
Managing Director at B.Riley Securities

Got it. I think you've already touched on this, but if the co pay is covered by commercial insurance and Medicare, what do you expect the monthly out of pocket cost will be for the patients in these two payers group?

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

I think for the majority of patients it's zero. We have a very liberal program to support the patients. And that's for commercial patients. With the Medicare patients, again, they have the yearly out of pocket limit for all medical costs. And that kicks in for cancer patient like the first month.

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

Yep. Got it.

Operator

Your final question comes from the line of James Malloy with Alliance Global Partners. Your line is open.

James Molloy
MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners

Hey, guys. Matt on for Jim tonight. Congrats on the progress and thanks for taking our questions. So first on the launch, I wanted to touch on how many reps are currently on board for the sales force and how many total planned reps you guys might add just for the launch in the KRAS mutated population? If you could go into that.

James Molloy
MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners

And then as well what the timeline might look like for the regulatory pathway for a MACI effect in in Japan and The EU?

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

I'll let you take the first part Mike and then I'll address We launched with

Michael Crowther
Michael Crowther
Chief Commercial & Strategy Officer at Verastem

a very focused team of 16 individuals. And as I've mentioned in earlier comments, while we'll keep a very close eye on that, we currently have no plans to increase beyond that.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

And then we haven't given specific guidance on Japan and The EU, but what we have said is we're doing a small bridging study in Japan that will it's actually wrapping up accrual now. And we intend to engage with the PMDA and seek conditional approval based on the bridging study. And we are already switching the sites in Japan over to be participants in three zero one and we'll put enough patients on Japan, so we'll be able to get full approval. But to be clear, you get full reimbursement in Japan based on conditional approval. Well, we haven't given specific guidance on the EU.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

We have engaged. We recently got orphan drug designation, which we think is an important part of the step and part of what we went through here in The U. S. To make sure it's recognized as a distinct disease. And then we'll be seeking formal scientific guidance on whether we can get approval based on Ramp-two zero one or whether we're going to need the randomized confirmatory study to get approval.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

With everything going on with MFN and unclearness around that, I'm not sure that rushing towards that is really something that we want to do anyway. Want to make it available to patients in Europe. But I do believe that even if we are able to get regulatory approval on the single arm study, most reimbursement in Europe will require the randomized study.

James Molloy
MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners

Got it.

James Molloy
MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners

Okay. Thank you guys for taking our questions and congrats again.

Dan Paterson
Dan Paterson
President, CEO & Director at Verastem

Thanks.

Operator

That is the end of the questions for today. Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

Executives
    • Julissa Viana
      Julissa Viana
      VP, Corporate Communications & IR
    • Dan Paterson
      Dan Paterson
      President, CEO & Director
    • Matthew Ros
      Matthew Ros
      COO
    • Michael Crowther
      Michael Crowther
      Chief Commercial & Strategy Officer
    • Dan Calkins
      Dan Calkins
      CFO
Analysts
    • Paul Jeng
      Vice President at Guggenheim Partners
    • Analyst
    • Pete Stavropoulos
      Director - Biotech Equity Research at Cantor Fitzgerald
    • Sean Lee
      VP - Equity Research at H.C. Wainwright & Co.
    • Anish Nikhanj
      Senior Associate - Biotechnology Equity Research at RBC Capital Markets
    • Graig Suvannavejh
      Managing Director at Mizuho Financial Group
    • Justin Zelin
      Director - Biotechnology at BTIG
    • Yuan Zhi
      Managing Director at B.Riley Securities
    • James Molloy
      MD & Equity Research - Biotechnology and Specialty Pharmaceuticals at Alliance Global Partners
Powered by Quartr