Good afternoon, and welcome to the Verastem Oncology Investor Conference Call on Tuesday, March 12, 2019. At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow.

Please be advised that this call is being recorded at the company’s request and will be available on the company’s website for a period of 90 days from today. At this time, I would like to introduce Ms. Erin Cox, Senior Director of Investor Relations & Corporate Communications at Verastem Oncology. Please go ahead..

Thank you, Kathryn. Welcome everyone and thank you for joining us this afternoon to discuss Verastem Oncology's financial results and corporate highlights for the fourth quarter and full-year 2018.

I'm joined today by Robert Forrester, our President and CEO; Joe Lobacki, our Chief Commercial Officer; Dan Paterson, our Chief Operating Officer; and Rob Gagnon, our Chief Financial Officer. During today's call, Robert will provide some introductory comments. Joe will provide an update on our commercial COPIKTRA program.

Dan will review our clinical development program and Rob will highlight our year-end financial results. Robert will then provide a brief closing summary before opening up the call to your questions. Earlier today we issued a press release detailing our financial results for the fourth quarter and full-year 2018.

The release is available on our website at Verastem.com.

Before we begin our formal comments, I will remind you that we will be making forward looking statements during today's call that represent the company's intensions, expectations or beliefs concerning future events which constitute forward looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.

All forward looking statements are subject to factors, risk and uncertainties such as those detailed in today’s press release announcing this call and in our filings with the SEC which may cause actual results to differ materially from the results expressed or implied by such statement.

In addition, any forward-looking statements represent our views only as of the date of this recording and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statement.

We refer you to the disclosure notice section in our earnings release we issued today and the risk factors section of the annual report on Form 10-K for a discussion of important factors that could cause actual results to differ materially from these forward-looking statements. With that, I would like to turn the call over to Robert Forrester.

Robert?.

Thank you Erin and thank you everyone for joining us this afternoon on this call. Late 2018 and early 2019 had an exciting time at Verastem Oncology as many of you know our lead oncology drug COPIKTRA also known as duvelisib received its first marketing approval from the US Food and Drug Administration in late September 2018.

COPIKTRA was approved as a safe and effective treatment for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies.

COPIKTRA also received accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma after at least to prior systemic therapies. Accelerated approval was based on overall response rate and continued approval in FL maybe contingent upon confirmatory trials.

COPIKTRA includes a Boxed Warning for fatal and serious toxicities, including infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. A Risk Evaluation and Mitigation Strategy or REMS program has been initiated to inform and educate healthcare providers and patients about these risks.

COPIKTRA is an oral inhibitor PI3K and a dual inhibitor of both PI3K-delta and PI3K-gamma. COPIKTRA is administered as a twice daily oral capsule that patients can take at home under the guidance of their physician.

The introduction of COPIKTRA into marketplace provides an important new treatment option for relapsed or refractory patients with CLL/SLL and FL who have few to know opportunities to treat their disease and manage their life.

Initially following the early FDA approval of COPIKTRA, our commercial team was mobilized the same day and began educating physicians, other healthcare professionals and payers on the clinical benefits safety profile and appropriate use of COPIKTRA and to secure access to therapy for patients.

Very quickly following approval COPIKTRA was added to the National Comprehensive Cancer Network, Clinical Practice Guidelines in Oncology for CLL/SLL, FL and also Marginal Zone Lymphoma or MZL is not the FDA approved indication. The NCCN guidelines understand the physician resource determining the protocol for treatment for patients.

And we believe these updated guidelines will help to increase awareness of COPIKTRA and help healthcare providers making firm decisions for patient battling with these difficult to treat advanced cancers. I'm very proud of our whole team in launching COPIKTRA in the US.

This is no small undertaking and it requires a lot of hard work, experience, persistence and perseverance. The US is clearly the most important market for us. However, we own worldwide right for COPIKTRA and we intend to bring COPIKTRA to those patients who could benefit in the major markets of the world.

We will mainly do this through collaborating with major pharmaceutical companies in each region. In June 2018 we entered into a license agreement with Yakult Honsha to develop and commercialize COPIKTRA in Japan that carries a total deal value of up to a $100 million, including a one-time upfront payment of $10 million.

Then in late September 2018 on the heels of the US approval we entered into a license agreement with CSPC to develop and commercialize COPIKTRA in China, Hong Kong, Macau and Taiwan. That carries a total deal value of up to $175 million including a one-time upfront payment of $15 million.

Both agreements cover the treatment, prevention and/or diagnosis of all the oncology indications in each respective territories and each have double-digits payout royalty on eventual commercial sales.

We are delighted to working with Yakult Honsha and CSPC and believe these partnerships highlight the global potential of COPIKTRA and we welcome the growing mix of strategic partners focused on bringing COPIKTRA to patients worldwide.

As we continue to execute the launch of COPIKTRA in US, we will be working collaboratively with Yakult and CSPC to rapidly evolve Yakult Honsha for the regulatory processes in Japan and China, and also meet the patients who need them.

Before I turn the call over to Joe for commercial update, I would just like to take a moment to mention another strategic collaboration that came to fruition in late 2018. Peripheral T-cell lymphoma is an aggressive type of non-Hodgkin’s lymphoma, it's an indication where in the future we are looking for expand the use of duvelisib.

In November duvelisib was selected for Leukemia Lymphoma Society’s Therapy Acceleration Program to evolve duvelisib as novel oral agent for treatment of patients with PTCL. The TAP program provides financial and other resources to support the duvelisib therapies for patients with blood cancers.

And we plan to use the funds from the TAP program to conduct certain translational and clinical activities relating to development of duvelisib for the treatment of PTCL. Portion to this PTCL program, we conducted in collaboration with Memorial Sloan Kettering, The Dana-Farber, Washington University in St. Louis and Stanford University.

With that, I will turn the call over to Joe to provide an update on the commercialization of the COPIKTRA. .

Thank you, Robert. 2018 was a landmark year for Verastem Oncology with the FDA approval and subsequent launch of COPIKTRA in late September. In terms of our commercial performance as we disclosed in our financial results press release, in 2018 since launch, we achieved $1.7 million in net product revenues.

As Robert mentioned, COPIKTRA is quickly added to the NCCN guidelines following its approval. And as of year-end 2018 we have secured reimbursement approval for approximately 75% of major targeted health plans representing 240 million US lives. As of yesterday, that number has increased over 90% of health plans providing reimbursement for COPIKTRA.

Even with this success, there's still much more for us to do to bring COPIKTRA to patients who’ve been battling. And a quick overview of the market opportunity and treatment landscape for COPIKTRA, currently in the US nearly 350,000 patients are living with CLL/SLL or FL.

Once diagnosed, a majority of patients cycle through several lines of therapy due to the chronic incurable nature of this disease. The treatment task can differ greatly based on the individual profile, including comorbidities, potential intolerance and non-response for available therapies such BTKs and BCL-2 who inhibitors.

When patients cannot tolerate a therapy or their disease stops responding the therapy, option for treating CLL becomes limited. This is where COPIKTRA and its dual inhibition of PI3K-delta and PI3K-gama fits into the CLL and FL treatment landscape for patients who are post two prior lines of therapies.

We believe COPIKTRA can fill that gap of therapy providing oral monotherapy therapy alternative once chemotherapy or other treatment options have failed to show additional benefit. For FL, it is important to remember that COPIKTRA was approved on accelerated basis.

We believe this reflects the unmet medical need for patients with relapsed or refractory FL. We are excited to be initiating our education and marketing campaign this quarter with physicians around the benefits and safety profile of using COPIKTRA to treat appropriate FL patients.

A key benefit of COPIKTRA for all potential patients is that as an oral monotherapy that could be taken at home twice daily. Thus making it especially advantageous for patients with ambulatory limitations or for patients who live a long way from the doctor's office, infusion center or tertiary care hospital.

The goal of COPIKTRA treatment is for patients to be able to take advantage of an at-home disease management under the guidance of their physician and to assist those patients in maintaining their lifestyle, family life, standard of living and productivity.

A large part of our commercial efforts to-date have evolved around educating physicians about Verastem Oncology, the need for PI3K as a patient option and the COPIKTRA information.

We have been working hard to help physicians overcome some of the negative perceptions that have been created by prior drugs in the class while being upfront about our safety profile and risk management or USPR. Overall, the poor perception of previous PI3Ks and physicians’ lack of clinical experience using COPIKTRA, have been headwinds.

This lack of experience and misperceptions are something that we believe we can overcome with our educational efforts aimed at physicians and other healthcare professionals by helping them understand the COPIKTRA data and the patients who could benefit from COPIKTRA as well as the management of patients being treated with COPIKTRA.

It's still early days in both the overall launch and the 2019.

We’re receiving positive feedback from the physicians who are prescribing COPIKTRA including their support for new treatment alternative of PI3K is an important mechanism and the importance of new mechanisms of action for patients who intolerated other classes have comorbidities or failed previous regimens.

For CLL/SLL and FL, we estimate that patient population in need of a new option is approximately 20,000 patients per year. As we projected it will take time to educate the medical community and have the physicians begin prescribing.

The natural evolution of a product launch is rarely linear instead it tends to grow as physicians gain experience with the product. We fiercely believe that the importance of COPIKTRA for patients and our whole team is diligently working to educate healthcare professionals and drive adoption of COPIKTRA.

Next, I’ll provide a quick summary of our ongoing marketing activities. In 2018 for May to mid September, we rapidly built the team and infrastructure needed to deliver on the promise of a novel agent, COPIKTRA. Our dedicated and experienced sales group for 50 sales representatives were in place prior to launch.

And today they continue to be actively supporting healthcare providers and their patients. We established a distribution network and successfully shipped product on the day we received COPIKTRA’s approval in September.

We have an exceptional team with extensive experience of launching new drugs and importantly in recognizing and understanding the needs that exists for physicians and patients. Our goal is to not only educate but support physicians and their patients to properly manage their disease so that patients can focus on living their lives.

In summary, we expect the COPIKTRA launch being a steady build throughout 2019. To-date, the US Commercial Medical Affairs and Access teams have done a great job of establishing appropriate payer, patient advocacy, physician, KOL, nurse and physician practice relationships.

This of course is related to the opportunity and a base to grow from in the months ahead.

As we continue further into 2019, we are focused on further increasing the number of doctors using COPIKTRA and continuing to work with the leukemia and lymphoma communities to increase awareness and help ensure patients are able to get the treatment and support they need. With that, I'll turn it over to Dan. .

Thanks Joe. Today we're focused on the near-term on the ongoing commercial launch of COPIKTRA in the relapsed or refractory setting for patients with CLL/SLL or FL that have had at least two prior therapies.

But we're also excited about the significant growth potential of COPIKTRA and other hematologic malignancies and potentially solid tumors in the mid to longer term. The composition of matter for COPIKTRA expires in 2030 before any extensions so we have time to explore the potential to help patients with others tumors.

Our strategy is to first extend the use of COPIKTRA in the additional lines of therapy in CLL/SLL and FL, both as a monotherapy and in combinations and then into other lymphoid malignancy such as PTCL and aggressive type of non-Hodgkin’s lymphoma.

We then see potential for expansion of COPIKTRA to help patients with other aggressive non-Hodgkin’s lymphomas, such as diffuse large B-cell lymphoma, Marginal Zone Lymphoma, cutaneous T-cell lymphoma, mantle cell lymphoma, Richter's transformation and transformed FL.

These are all indications where combinations with novel and standard-of-care agents could really make a difference. Beyond that, we see potential for COPIKTRA in combination with other immunotherapies and CAR-T, both in hematologic malignancies and possibly certain solid tumors. This is our vision for the potential for COPIKTRA.

I'd like to update you on where we are today with these development programs, both from the company initiated studies and also with investigator sponsored studies. Last week at the 23rd annual International Congress on Hematologic Malignancies, four abstracts represented which continue to support the use of COPIKTRA in CLL/SLL and FL.

The key abstract at the meeting highlighted data from the Phase 3 dual study evaluating COPIKTRA compared to ofatumumab in patients with relapsed to refractory CLL/SLL after at least two prior therapies. This is the labeled indication for which COPIKTRA received approval in September of 2018.

In this analysis COPIKTRA demonstrated progression free survival of 16.4 months compared to a PFS of 9.1 months for patients treated with ofatumumab. COPIKTRA also demonstrated an overall response rate of 78% compared to 39% for patients treated with ofatumumab.

The other three COPIKTRA posters from the ICHM featured long-term efficacy and safety data from patients treated with COPIKTRA. One abstract described long-term efficacy and safety analysis of four studies evaluating COPIKTRA in patients with relapsed or refractory CLL/SLL that have been on therapy for greater than two years.

The main finding was that this subset of patients who received duvelisib monotherapy achieved an overall response rate of 89% with a median PFS of 40 months and observed side effects that were consistent with previously described treatment related events for COPIKTRA.

The investigators were able to manage most adverse events through dose reductions and dosing holds, allowing these patients to continue treatment.

In an abstract on the dual crossover study, the 90 patients who crossed over to dual list and once they progressed following treatment with ofatumumab achieved an overall response rate of 77% with a median PFS of 15.2 months.

This result was consistent with the strong activity of duvelisib in the parent dual study and showed that most patients who failed an additional line of therapy continue to benefit from duvelisib therapy. Now to some other important data presented in 2018.

At ASH in December data we presented from investigators sponsored Phase 1 trial investigating duvelisib in combination with romidepsin in patients with relapsed or refractory T-cell lymphoma, including PTCL and cutaneous T-cell lymphoma.

Of the 27 patients with PTCL, the overall response rate was 59%, including 22% who responded deeply enough to allow them to bridge to potentially curative stem cell transplant. The median PFS for patients with PTCL was 6.72 months. However, this was confounded by the six subjects who then proceeded the stem cell transplant.

We plan to use funds awards to us from the LLS TAP program to expand this study and enroll a total of approximately 50 patients.

Then in mid 2018 at the European Hematology Association Annual Meeting data were represented from an investigator sponsored Phase 1b/2 trial and began investigating duvelisib in combination with fludarabine, cyclophosphamide, and rituximab, commonly referred to as FCR as a front line therapy in younger patients with CLL.

The overall response rate in this study was 94% with 52% of the patients achieving a complete response or a complete response with incomplete hematologic recovery. Importantly the MRD negativity rate in response to treatment was 76% in this study.

The two year progression free survival and overall survival rates for patients in the study were both 97%. These early data demonstrate duvelisib’s potential combinability with chemotherapy and potentially used in a frontline setting.

The most common adverse reactions occurred in 20% or more patients across these studies were consistent with the COPIKTRA label and included diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain and anemia.

Before I turn the call over to Rob for the financials, I'd like to just mention two additional studies that are currently ongoing and worth watching.

First is the company sponsored PRIMO study an open label multicenter Phase 2 clinical trial evaluating the efficacy and safety of duvelisib monotherapy in adult patients with histologically confirmed relapsed or refractory PTCL.

This is an important study because it potentially allows us to file for accelerated approval for PTCL if the trial is successful. The other ongoing trial as investigator sponsored Phase 1/2 study evaluating duvelisib in combination with venetoclax, an oral selective inhibitor of BCL-2 in patients with relapsed or refractory CLL/SLL.

The primary objectives of the Phase 1 portion of this trial, is to determine the maximum tolerated dose and the recommended Phase 2 dose of venetoclax to this combination regimens.

This is an important proof-of-concept study to validate the preclinical synergy that we have seen to show that venetoclax and duvelisib can be combined and to potentially broaden the utility of duvelisib into some higher risk patient populations. We're committed to exploring the use of duvelisib in multiple indications and settings.

Long-term, we see significant potential to create many new and exciting options for patient care based on the mechanism of action of COPIKTRA, which includes effects on PI3K-delta and gamma inhibition of both the tumor directly and the tumor microenvironment.

Our approach is to follow the science and the unique mechanism of COPIKTRA to support the future development [Audio Gap] oral agent as both the monotherapy and in combination with both targeted and immuneoncology agents in a broad range of hematologic and solid tumors. We believe there are many more opportunities to be unlocked.

I'll now turn the call over to Rob for financials.

Rob?.

Thank you, Dan. Since we issued a press release earlier today outlining our fourth quarter and full year 2018 financial results, I'll just review the highlights beginning with our cash position, then the full year 2018 results.

As of December 31, 2018, Verastem Oncology had cash and investments of $249.7 million compared to $86.7 million of cash investments as of December 31, 2017. Net product revenue for the full year 2018 was $1.7 million compared to zero product revenue for the full year 2017.

As a reminder, we recognize product revenue when product arrives at our specialty distributor or specialty pharmacy network from our 3PL. License revenue for the full year 2018 was $25 million and was related to the license agreements with Yakult and CSPC.

Research and development expense for the full year 2018 was $43.6 million compared to $46.4 million for the full year 2017.

The $2.8 million decrease was primarily related to a decrease of $6 million in license fees related to a one-time milestone payment pursuant to the Infinity license agreement that was recognized in 2017, and a decrease of approximately $3 million in consulting fees, partially offset by increases of $4 million in personnel related costs and approximately $2 million CRO expense.

Selling, general and administrative expense for the full year 2018 was $77.3 million compared to $21.4 million for the full year 2017.

The increase of $55.9 million resulted from an increase in personnel related costs of approximately $27 million related to the hiring and staffing of our sales team as well as an increase in consulting and professional fees of $24 million related to the support of the commercial launch.

Net loss for the full year 2018 was $72.4 million or $1.12 per share, compared to a net loss of $67.8 million or $1.76 per share for the full year 2017. Before I turn the call over to Robert for closing remarks, I would like to highlight one other recent transaction that underscores the value of COPIKTRA.

Last week Infinity Pharmaceuticals announced that they had monetized their royalty rights to COPIKTRA to HealthCare Royalty Partners for $30 million upfront and up to an additional $20 million in sales milestones.

I'd like to remind everyone that we are obligated to pay Infinity a tiered royalty on sales of COPIKTRA ranging from mid single to high single-digits. This was the portion of the royalty that was sold and I highlight this point because it represents a small part of the overall product as a whole.

It did not include the additional royalty that the company is obligated to pay to Infinity that as owed to MundiPharma and Purdue Pharma. Now, I will turn the call back to Robert for closing remarks and to open the call for questions. .

One, ensuring to expand on the commercial traction of COPIKTRA in CLL/SLL and FL for appropriate patients. Two, initiating a confirmatory Phase 3 study evaluating duvelisib for treatment of patients with relapsed or refractory FL after at least two prior systemic therapies. The confirmatory study is expected to start in 2019.

Supporting additional investigational studies of duvelisib both through company and investigator sponsored studies. Four, working with Yakult and CSPC on the LLS to advance the development and expansion of the COPIKTRA brand. Five, one more ex-US partnership with duvelisib.

And six, advancing our focal adhesion kinase inhibitor defactinib which is currently being evaluated in four separate clinical collaborations in combination the immunotherapeutic agents.

At a twice daily oral monotherapy we believe that COPIKTRA is an attractive treatment option for both physicians and patients first in CLL/SLL, FL and potentially in other high unmet need lymphoid malignancies in the future.

I recognize the challenge with the launching of novel therapeutic where there are challenges for own perceptions of the class and limited clinical experience. However we’ve come a long way since in-licensing COPIKTRA in late 2016. We successfully got COPIKTRA approved by the FDA and it has a long patent life ahead.

I'm confident in our strategic and operational plans, the team we have built and our ability to execute on our mission to help bring COPIKTRA to patients in need and to change the way cancer is treated, one patient at a time. With that, we will now open up the call for your questions.

Operator?.

Thank you. [Operator instructions]. And our first question comes from Robert Hazlett with BTIG. Your line is open..

Hi, this is actually Jake Colby on the line for Bert. Thanks for the question and congrats on the progress.

I guess just to start with COPIKTRA on the market for a few months now, has there been any evolution in the sales and education message to physicians to address the PI3K perception headwind?.

Yes, it’s great, obviously, we -- as I say little surprises, but obviously, you learn things as you progress. And so I think we're refining messages relevant, so they’re going down completely different path. But let me let Joe comment more deeply about that..

Yes, so Jake, thanks for the question. We have been kind of changing as we move along, which is a planned part of the launch. So when we launched we wanted to come out as what is COPIKTRA, it’s dual inhibitor of delta and gamma, so it's really first and only, so it was new in this class. So we presented it that way.

And we started giving the information around CLL. So what's evolving is more around going away from the dual inhibition to the efficacy and safety of the product. And then also the FL, going from CLL to the FL campaign. So we started with CLL, we're now evolving into the FL campaign, which I think is a great spot for us.

So the message has evolved over the past couple months, but all of the messages have been resonating very well with physicians..

Okay, thank you. That's helpful.

And then I was just wondering if we could get any sort of commentary on expenses for 2019 and how we should think about their trajectory throughout the year?.

Absolutely. So I'll hand you over to Rob to answer that question on expenses for this year. .

Yes. Thanks. And as you know it's very early on in both the launch and the calendar year as it relates to guidance. We won't be giving guidance and so at least the end of the year. We really need to get a solid idea of the ramp and the overall growth patterns before we comment to specific guidance.

I will point to you however on the expense side, based on as noted in our earnings release today, our operating expenses were about $35 million. That compares to about $37 million in the third quarter.

That should give you a sense for where we are in terms of the back half of last year, but we won't be giving specific guidance on the projected revenue expense numbers for the end of the year..

Thank you. And our next question comes from H.C. Wainwright. Your line is open..

Thank you. Good afternoon Robert and team. I have a couple of quick questions.

In terms of the education programs that the commercial team is planning so that it can increase the clinician’s experience, can you give us some color as to what sort of programs are you thinking about for that to happen in 2019?.

Yes, thanks, RK. I mean as you know, some of the headwinds that we knew when we bought this product in was some of the negative perceptions around PI3K. And so we are obviously addressing those head on and really owning the benefits and side effects of the drug. But let Joe to a little more detail about that. .

Sure, thanks, RK, this kind of builds on Jake’s question as well. So again, when we launched we were really looking at kind of coming out as a novel agent how we're different in the space to introduce COPIKTRA.

As we moved forward we’ve done more around the piece for CLL as well as the management of the profile of the product, and now we're moving into the FL piece of it.

We're also doing around the message is, to really look at what are the patients that physicians are looking to treat? So we just actually came off of our national sales meeting last week where we had a robust discussion around what are the patients that we’re looking to treat, we had two KOLs from the field come in to help work with our sales representative, to help representatives to identify those patients.

So as we look at it, where physicians are trying to fit in, which where does this fit in? And here is the question, actually, when we're out with investors as well, where does it actually fit in.

And what we're looking to do is this post two prior lines of therapies, so that that patient who is now being treated with chemo, ibrutinib, maybe another product like venetoclax, and then there's no option for those patients, where they're being treated right now is really an open space because there's no treatment in that post two priors.

So we're developing those programs around to really identify physicians where we fit in and we have right fitters according to our filler label.

So we'll do the same thing now with FL as we launch the FL campaign going forward is to really look at, what happens post two prior chemotherapies in follicular lymphoma, and it's really an open space because there's no ibrutinib, there’s no venetoclax. It's really a PI3K case base.

So how do we fit ourselves as a PI3K of choice and that goes back to how we launched. Looking at it as a novel agent delta-gamma, our profile around efficacy 42% being in double refractory patients which is different than the other products that are out there.

So really our educational programs are established ourselves in CLL those two prior lines which in open space and an FL post two prior lines which is really an open space as well and it's definitely a PI3K space.

We're also working with the Medical Affairs team to bring more physicians in to having experienced with COPIKTRA through clinical programs, through their own ideas as we initiate those, but also some programs that we're looking at for Medical Affairs to initiate that something like a registry study, so to provide them with experience.

So we're hitting them from both ends. Where does it fit in? And there’s a clear open need in these posts two priors and we giving the experience. .

So, Joe with your experience of having launched drugs before, how does in your world, how does this seem comparing it against your previous experience and are there things that you feel requires a little bit of attraction to probably a certain things which requires a lot of treat.

So how do you see this and what is some of the anecdotal information that you're getting especially now that the drug has been out for like close to five to six months? And then the second part of the question is on the clinical side.

So based on some of the things that you have been hearing and based on some of the clinical studies that have been highlighted so far in this call, I would like to know what sort of data expectations we should have, and also how you're trying to tie that data with the message on COPIKTRA, just as you're trying to do this on this call with the physicians?.

Okay. There's lot of great questions in that, I think two main ones, the first one, Joe, can you talk a bit about your prior experience in other oncology drugs? How does that -- how the experience is compared to what we're seeing here? That's the first question. .

Okay, yes. And RK I think one of the things you said in terms of the -- we've been out now for about five months. And that's really the period of time we've had to introduce both Verastem Oncology and COPIKTRA to the marketplace.

So as you recall that Verastem picked up duvelisib in fact at the end of 2016, developed it, mostly experienced clinical trials was in Europe, not within the US. So it's building that base of support right now, the company has picked up.

So over the past five or six months the team at Medical Affairs, Commercial has done a great job building that base. And from my experience, that's the important piece of it, people kind of touch the product and being able to work with it. We've got some great folks out there who have done that and are supporting us.

We need to continue to pull that through and I think it's -- first party started with that five to six months since launch. So we still have ways to go, but it's going well in gaining that experience. .

So, actually I think the first half. The second half was really talk about, the clinical studies, and maybe more broadly, the brand expansion strategy, and I think a couple of quick comments, and I'll hand over to Dan. I mean, first thing is, we now have an approved drug.

We’ve run the corner to corners of the biology of clinical trials and also through the FDA. We've got long IP as Dan pointed out 2030 before extensions. We’ve got 13 or 14 years of exclusivity. We’ve got -- thanks to Rob, he has raised good capital. We've got a great team.

So we have got time to really explore the potential for this drug in earlier lines of therapy and also in different indications both in monotherapy and combination. So maybe with that let Dan comment a bit more. .

First and foremost, we want to own our indication. We want to own two more lines of therapy in CLL or FL.

And I think you saw some of the data that we presented recently that was really data that was taken out of studies that where the top-line has already been reported, when we give more information around how well the drug works, how well it works in certain subpopulations and tolerability of the drug. And that's really job once.

Then when we look at broadening the reach it’s really expanding the use and CLL/SLL and FL. And if you look at the investigator sponsored studies that are going, MAT agent study combining with venetoclax that's potentially very important study.

As an IHC, we don't necessarily control the timing and when that data comes out, but it's moving very rapidly and we would expect to see something hopefully in the near future. The PTCL study, we've talked about three months, again the data from that first portion of that study is likely to be reported out the second half of the year.

While we're not releasing any data now I will tell you it accrued much more quickly than we ever expected, which is usually a good sign that physicians are seeing something they like.

And then as we start going in to more aggressive subtypes in non-Hodgkin’s lymphoma, you'll really see a lot of the investigator sponsor studies we're doing in the more aggressive subtypes DLBCL, MCL, Richter's are really supported by some of the combination work that’s being done now because once we show we can safely get duvelisib together with a drug like venetoclax we can look at other areas we can go into.

And then we’ve reported 50 some of the preclinical data around what I would view kind of a homerun for COPIKTRA which is if we can go into combining with IO, CAR-T, essentially crossover solid tumors, you were hoping to get those studies started later this year and really go from there.

But it's a combination of mining the data we have from the previous studies, getting readouts from some of the studies that have progressed a little farther and then moving into the others..

Thank you. [Operator Instructions] And our next question comes from Matthew Cross with Jones Trading. Your line is open..

Hey guys, congrats on completing the first full quarter of COPIKTRA sales and thanks for taking my questions this afternoon. Starting off I wanted to ask, you mentioned this increase now up to 90% and then reimbursement coverage.

And I was wondering if you could kind of give some color around what drove that increase whether -- at least in if there was one particular driving force whether that was some dataset, whether discussion of FL given the recent publication and ability to know market beyond the package inserts, and is there any reason to expect you to achieve 100% coverage or near 100% coverage in the next few quarters as things progress?.

Great question and I can answer your question very easily. We got a great team that’s working incredibly hard, certainly have more color than that but that certainly is a large part of it, I mean they really are very dedicated, very experience and they’re already working at.

But Joe you want to add anything to that?.

So I totally agree with Robert. From the sales team through to Market Access team, through to Medical Affairs team, the back and everybody else, they've done a great job over the past year. And actually we're in a place -- RK had asked about my experience.

We're in a place that usually at this point in time ago we’re going, I could do a lot better if I just had reimbursement support. So that we have, we've got that reimbursement support. So that's fantastic.

But what drove it was really beginning of last year, we had I think our first payer meetings back beginning in the March, if I remember maybe in 3rd of March, we were talking to them.

So we've been working very hard with the payers to introduce them to Verastem, and so there’s COPIKTRA in the data and we've been pulling that through throughout the year. So it's been a very -- I think the Market Access team has done great job, as Rob was saying. So we've educated them on the product, the class that fits in and they're aware of it.

And we’ve brought in kind of our medical affairs team with physicians to back it up, why is this an important drug for patients? Now getting to a 100%, do I think we'll get there? I think we will, maybe 99% or otherwise. But I think we'll get there. There are a couple other folks we need to pull in, yes, but I think we'll get there.

So again, team has done a great job..

Great. Glad to hear and hope to see that continue.

Next one was on just kind of the cadence of up-sales what maybe the first year, so including this quarter, and say the first three of 2019, just kind of hoping your expectations for what I would expect would be in initially lumpier period during that first year as you're improving inventory build and improving distribution efficiency, before we kind of make an assessment about the real sales trajectory.

Would you expect us to be say in this first year kind of back end loaded in terms of sales and is this in any way impacted by the time in we should recognize revenue when that reaches distributors?.

Thanks, Matt. It's a great question, it’s something we think about a lot, obviously. It's -- we're not we're not giving financial guidance, but I think some of the color that you're asking, I think you totally said to talk about, we see this as being a sort of building year and it is starting to catch eye, it’s more towards the back end.

And we’ve definitely got some of those headwinds that we knew about that we're overcoming, but it does take time. So maybe, Joe, if you want to give a little more color, maybe Rob do you want give some guidance after that -- not official guidance, obviously..

Yes.

So I agree I think it's a slow build over the years in the first year of sales as we want to educate more physicians get them to putting new patients on and then as we start getting into the annuity of patients continuing on to therapy, one of the abstracts that the Dan had mentioned patients around for 13 months so that's a great thing for us for the future.

So as we get patients on our goal is to keep them on currently and build that kind of going forward. And I think as we deal with some of these headwinds of getting in, talking about how we're a different PI3K physicians can use this drug and manage. And then they just start writing for patients.

So I think there will a build throughout the year and you're right you're looking at the projections more sales force for back half the year..

And, hey Matt, it’s Rob. I'll just add to that, you asked about rev recognition. So the revenues recognized when the product is received by the specialty pharmacy or the specialty distributor and shipped from our 3PL, so that's how that works. And it's typically a turnaround time, 24 hours..

Perfect, I appreciate all that detail and very helpful with that, obviously getting into specific numbers and guidance here. And then just one more before I jump potentially back in the queue here.

Was curious obviously with so much focus on commercialization right now and that being a crucial driver of the company's growth wanted to get a sense for given everything you're doing on the R&D side of things as well kind of where the focus is, I know there's a lot going on between PTCL this confirmatory Phase 3 in FL various combinations, kind of a lot going on beyond obviously the PRIMO study that's very much on going, what kind of is the focus that we should be paying attention to most maybe in terms of key catalyst for this year and maybe an initial label extension?.

Yes, that's a very important question. I mean, job number one and Dan said this very, very well, job number one is to make sure we execute on the launch and Joe and the team on point clearly for that. Job number two is to maximize the potential for duvelisib.

Again we have long patent life on this drug, we know mechanistically that this drug has the potential to go into many other tumor types.

And so we need to explore those and explore those quickly and efficiently, so it's through company sponsored studies and also through investigators sponsored trials and we're starting those -- we've already started some of those class combination, the PTCL programs, two of them that are going on. We see a lot of potential there.

And so that's step job number two. And job number three is what else, what other products can we bring forward? And clearly we have Defactinib, and Defactinib is in those four programs. And we have to start to see some data coming out from those trials in sort of throughout this year.

So the fact that it is going to be potentially important drug, we don't know yet, the theory is still out on it. And then what else and then in due course, that may be what else is to.

So Dan, is there anything you would like to add to that?.

No, I would just like emphasize the PTCL study. And that's likely to be the next label expansion.

And, I would say if you looked at the Phase 1 data, it was pretty exciting data and there’s almost a halo effect, when you talk to KOLs about the PTCL data and our plans for the future and they are very excited that we have multiple requests for ISTs for example in that area, and so as we look at the more aggressive lymphoma, so I think that's going to be a big area of growth for us..

That's a good point just to emphasize and we've been very focused up until the approval on getting the drug approved and we hadn't initiated a lot of additional studies, we were again very close to get the drug approved. Now that drug is approved it gives the opportunity to broaden into additional indications and trials.

And it has been extraordinary the interest that we have received from physicians, KOLs around the country and in fact around the world to try to picture in different tumor types, different combinations and you're going to start to see those rolling out as the year goes on.

So it's been very heartening and very exciting to see the scientific interest in taking this drug potentially into new indications..

Thank you. Our next question comes from George Zavoico with B. Riley FBR. Your line is open..

Hi, everyone. Thanks for taking my questions. Nice to see the sales progressing as you described. So I have a question about the European discussions with the EMA.

Where do you stand with getting COPIKTRA approved in Europe?.

Quite important question. As you know we own the worldwide rights to the drug and are clearly US is the most important market and we're putting almost all our efforts into US.

And we want to commercialize in other regions of the world because there are patient everywhere that could benefit from this drug and we want to make sure we bring that -- bring COPIKTRA to those patients in an effective manner.

You saw SCPC in China, Yakult in Japan and you just probably expect to see one more collaboration over the next -- for the rest of this year. However, that is not likely to be in Europe. And so we are taking a different approach in Europe and the most of open approach, I may let Dan talk about that in more detail. .

Sure, George as you can imagine when we set the priority review in the US and things moved pretty quickly it kept our regulatory team pretty busy.

And so when we got the early approval for COPIKTRA, we really moved a number of those resources to focus on the EMA and we're actively working now in strengthening our KOL network in Europe, as you know that's part of very important through the approval process and then finalizing our regulatory strategy in Europe.

We’ve boosted -- there was a question earlier about clinical development as well as on the regulatory side, you probably saw the announcement of -- when we brought Bob Morgan on recently, one of the reasons we brought him on was to expand both our capacity on the clinical side, but he also has a great deal of international regulatory experience which is helpful to us both in the EMA as well as working with our partners in China and Japan.

And so that's a big focus of the team right now. And we'll give more guidance on EMA and timing probably in the latter half of this year..

Okay. And part of the education that you guys need to do obviously with the very sort of poor perception of PI3Ks is about handling and recognizing when some of the warnings of the -- in the Black Box actually begin to appear as symptoms. So can you describe a little bit about how that's going whether the rate of dosifications or dose reductions.

Have you been tracking that or now that COPIKTRA is out on the market? And are you seeing the physicians are sort of adapting well, perhaps the more they use it, they adapt better.

But any comment on that would be helpful?.

No, it's a really important question and we're taking a very different approach. There's a lot of companies in the past who are on PI3K. We are really holing the side effects and embracing them and providing the materials and education to the physicians and nurse, physicians’ office and directly to the patients.

Make sure we know what to say because in general these side effects are predictable and manageable and then side effects that many physicians are very familiar because they are dosing IO drugs and guess what, there seemed many of the same side effects.

So it's much more wanted education and much more wanted overcoming perceptions than anything else anything more real in that. So, let I handed it over to Joe, maybe Dan, you want to comment as well.

But Joe, do you want to add to what I just said?.

Yes. It’s been an important part of the launch and will be going forward as well.

So it goes all the way back to the people that we hired in oncology account managers or sales team that we wanted them to be kind of upfront about side effects what to know our physician and what to expect, when to expect it and what to do going forward and that has driven a lot of very robust conversations which has been great.

So that's going well and to-date patients are -- what we're seeing is, patients do well in therapy. And again, just as long as physicians know about it, they feel more comfortable about it and how to manage it as well. So it's a big piece of our sales efforts..

Well I was just going to comment on, what data we have so far on usage in the market. I mean the nice thing about starting from scratch with all our systems as we've designed our systems, we can actually track that, real life usage and delays in dose reductions and things. I would say it's just way too early right now.

I mean, the numbers are too small, too early draw any conclusions..

Okay, and I guess as we go we will learn more about that with every quarter. Okay. And then in terms of just recent, maybe again it’s also too early.

How many repeat scripts versus new scripts? Can you talk about that or is it way too early for that too?.

George, it's important data as well. It's too early, because it leaves us what three or four months into the launch. We obviously know that that many patients are having repeat scripts but terms of the numbers it's probably too early to make anything of the data. .

Thank you. And our next question is a follow-up from Matthew Cross with Jones Trading. Your line is open..

Just had one kind of as you think about BD opportunities for COPIKTRA beyond geographical deals? I understand you're likely to be opportunistic, but would you say you're committed to commercializing in the US entirely internally or open to a co-commercial or out-license situation maybe for certain indications where there may be some kind of added synergies from the existing offerings of other place in the space?.

I mean, it's a very important question. Heart of our business is commercializing in the US. We are not open to co-commercialization and also setting up indications is not something that is particularly easy to do or to track.

Now we believe in this drug, we have the team and we have the right team, we have the capital, we have a great product, we want to commercialize in the US. and want to own that. And that's how we can build a nice business here.

And the second is, we're thinking about what we should do in Europe, whether we should be fully commercial in Europe or whether we should partner in Europe. And that's something the decision that we're keeping open. We want to move the regulatory path, down the regulatory path a bit more before making that kind of decision.

So definitely in the US we're not open to BD conversations. .

And Robert, I guess I would add I mean, one of the things we're already starting to hear back from the field is very good feedback on our people and how they interact and how responsive we are as a company and things like that are hard to continue if you find a partner, I mean it’s something that we want to continue to be known for the way we do things..

No I mean in no ways to try to serve the negative message of the strong progress Joe and the rest of the team are making here. Just wanted to clarify as far as the strategy and then how we should think about it as we're moving. .

We are delighted to owning this drug and we're delighted to have the opportunity to commercialize this in the US. .

Thank you. Ladies and gentlemen, this concludes our question and answer portion of today's call. I'd like to turn it back over to Robert now for any additional closing remarks..

Thank you. Thank you very much for joining us for the great questions. In closing, I just like to thank everyone again for joining today's call. This is a very exciting time for Verastem Oncology and we are now delivering on our mission to improve the lives of patients with cancer. Have a good evening..

Ladies and gentlemen, just as conclude the conference call for today. We appreciate your participation and you may now disconnect. Have a great day..