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SEATTLE GENETICS INC (SGEN) Q1 2019 Earnings Call Transcript

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SGEN earnings call for the period ending March 31, 2019.

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Q1 2019 Earnings Call
April 25, 2019, 4:30 p.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Good day, and welcome to the Seattle Genetics First Quarter 2019 Financial Results. Today's conference is being recorded.

At this time, I would like to turn the conference over to Peggy Pinkston, Vice President Investor Relations. Please go ahead sir, ma'am.

Peggy Pinkston -- Head Of Corporate Communications

Thank you, operator, and good afternoon, everyone. I'd like to welcome all of you to Seattle Genetics First Quarter 2019 Conference Call. With me today are Clay Siegall, President and Chief Executive Officer; Todd Simpson, Chief Financial Officer; and Roger Dansey, Chief Medical Officer.

Accompanying today's conference call are supporting slides, which are available on our website in the Investors section under the Events and Presentations page. And following our prepared remarks today, we'll open the line for questions.

Today's conference call will include forward-looking statements regarding future events or the future financial and operating performance of the company such as those, among others, relating to the company's 2019 financial outlook, including anticipated 2019 ADCETRIS sales and future revenues; cost and expenses; and the company's potential and anticipated timing to achieve future clinical and regulatory milestones, including data readouts, regulatory submissions and approvals.

Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Among the factors that may cause such a difference include the difficulty in forecasting sales, revenues and expenses and the uncertainty associated with the pharmaceutical development and regulatory approval process.

More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors, included in the company's periodic reports filed with the Securities and Exchange Commission, including the company's annual report on Form 10-K for the year ended December 31, 2018.

Now I'll turn the call over to Clay.

Clay Siegall -- Chief Executive Officer

Thanks, Peg, and good afternoon, everyone. During the first quarter of 2019, we further positioned Seattle Genetics to become a multiproduct oncology company. This was illustrated by the remarkable top line data we reported from the enfortumab vedotin in trial in metastatic urothelial cancer, which puts EV on path to becoming our next marketed drug.

We have also reached the targeted patient enrollment in pivotal trials of our 2 other late-stage programs, tucatinib in HER2-positive metastatic breast cancer and tisotumab vedotin in metastatic cervical cancer. These late-stage pipeline milestones are in addition to continued ADCETRIS sales growth. ADCETRIS net sales in U.S. and Canada were $135 million in the first quarter.

ADCETRIS sales are typically lower in the first quarter and grow throughout the year. Ordering patterns in January were light compared to December, but we have seen growth month-over-month since then including a strong April to date. Sales in the first quarter of 2019 increased by 42% over the first quarter of 2018. And we are maintaining our guidance of full year 2019 ADCETRIS net sales in the range of $610 million to $640 million.

We expect ADCETRIS sales will continue to grow in the U.S. and Canada driven primarily by our 2 frontline approvals in 2018. First, stage III and IV classical Hodgkin lymphoma in March and more recently, CD30-expressing PTCL in November. This brings the number of approved indications to 6 since initial launch in 2011.

One key dynamic in frontline Hodgkin lymphoma is the NCCN Guidelines, which are more restrictive than our labeled indication. These guidelines are translated into treatment pathways. Importantly, there was a recent update to NCCN Guidelines for ADCETRIS in a number of clinical settings. In frontline stage III and IV Hodgkin lymphoma, the guidelines are now less restrictive toward utilization of the E1 regimen.

Notably, the compendia listing now includes a 2A recommendation for patients with no known neuropathy. This provides an opportunity for our commercial and medical affairs teams to update physicians and work with pathways toward more closely aligning use of ADCETRIS with the approved frontline indication. Roger will speak to other recent changes to the NCCN Guidelines.

We are intensifying our efforts to increase Hodgkin lymphoma patient awareness notably through digital patient outreach. Upon diagnosis, we know that many patients spend a significant amount of time online researching the disease and treatment options.

This information allows patients to understand the role that ADCETRIS could have as they discuss treatment options with their physician. We believe raising awareness among patients is important because many physicians see only a few Hodgkin lymphoma patients per year.

I'll now turn to our most recent frontline approval in PTCL. While still relatively early in the launch, we're hearing positive reactions to the E2 data, especially to the overall survival advantage that showed a 34% reduction in the risk of death. The efficacy advantage of the ADCETRIS plus CHP regimen demonstrated by the E2 trial resulted in its rapid inclusion in the NCCN Guidelines and treatment pathways that are consistent with the label.

There is a significant unmet need in frontline PTCL, and our goal is to establish ADCETRIS plus CHP as the new standard of care for CD30-expressing PTCL patients in the U.S. We and our partner, Takeda, have also made progress outside the U.S. with frontline approvals. In frontline Hodgkin lymphoma, ADCETRIS was approved in Japan in September and in Europe in February. These approvals triggered a combined $40 million in milestone payments to us.

In Canada, we also expect a approval decision in frontline Hodgkin lymphoma in the near term, and we recently submitted an application for approval in frontline PTCL. Takeda plans to submit E2 to the EMA and other health authorities this year for frontline PTCL.

I'll move on now to enfortumab vedotin or EV, which we're developing in collaboration with Astellas. In late March, we reported positive top line data from the pivotal Phase II trial, EV-201, in patients who had received both a platinum-containing regimen and the PD-1 or PD-L1 inhibitor.

The EV-201 data will be presented in an oral session at the American Society of Clinical Oncology annual meeting in early June. The pivotal trial also forms the basis of the Biologics License Application that we plan to submit to the FDA this year under its accelerated approval mechanism. We believe the activity and safety profile will be well received by the physician community and may lead to a new standard of care for these patients.

This is a transformational period for Seattle Genetics as we expand from hematologic malignancies into a multiproduct company with drugs that also target solid tumors. In addition to EV, we're advancing tucatinib in HER2-positive metastatic breast cancer as well as tisotumab vedotin in metastatic cervical cancer. Both of these programs are in pivotal trials. These are followed by a number of earlier-stage programs, including both ADCs and novel agents.

Our portfolio is strongly positioned to address the significant unmet medical needs of cancer patients. Antibody drug conjugates are playing an increasingly important role in cancer therapy. This is demonstrated by our results with EV, the positive impact ADCETRIS is having globally in the treatment of lymphoma and progress by other companies.

We also have several collaborator ADCs in late-stage development. These include polatuzumab vedotin from Genentech/Roche, which has received priority review in the U.S. for relapsed diffuse large B-cell lymphoma and a PDUFA date in August 2019.

An approval application was also filed in Europe. GSK is advancing in ADC for multiple myeloma in several ongoing trials and is planning a regulatory submission in the second half of 2019. And AbbVie has an ADC in a Phase III clinical trial for glioblastoma with data expected in 2019. It's an exciting time in the field of ADCs.

Now I'll turn the call over to Todd who will discuss our first quarter financial results and then Roger will provide additional comments on our clinical development activities. Todd?Great. Thanks, Clay, and thanks to everyone for joining us on the call this afternoon. Today, I'll summarize our first quarter 2019 financial results and provide a few updates to our guidance for the year.

Total revenues in the first quarter of 2019 were $195 million. This included ADCETRIS net sales in the U.S. and Canada of $135 million. This was a 42% increase over the first quarter of 2018 and reflects the 2 label expansions in frontline Hodgkin lymphoma and PTCL. Takeda sales increased meaningfully over the first quarter of 2018.

However, royalty revenues in the first quarter of 2018 included additional amounts attributable to Takeda's portion of third-party royalty obligations some of which expired in 2018. Therefore, despite the increase in sales by Takeda, royalty revenues in the first quarter of 2019 were comparable and the cost of royalty revenues decreased.

Collaboration revenues were $45 million in the first quarter of 2019 primarily driven by amounts earned under our ADCETRIS collaboration with Takeda and our ADC deals. This includes the earned portion of a $30 million milestone payment from Takeda related to ADCETRIS approval in Europe for frontline Hodgkin lymphoma.

Turning now to expenses. R&D expenses were $158 million in the first quarter of 2019 compared to $153 million in the first quarter of 2018. Expenses in 2019 primarily reflect investment across our pipeline, notably our late-stage programs, EV, tucatinib and TV.

SG&A expenses increased to $80 million in the first quarter of 2019 compared to $66 million in the first quarter of 2018. This increase reflects commercial efforts to support ADCETRIS in the new frontline indications as well as costs related to our late-stage pipeline programs.

We ended the first quarter with $418 million in cash and investments. This is an addition to approximately $148 million in common stock holdings in Immunomedics at the end of the quarter. As a reminder, these shares are mark-to-market and that resulted in a noncash investment gain of $38 million for the first quarter.

Regarding our 2019 financial guidance, last quarter, I mentioned that we expected to provide updates based on progress with our late-stage programs, including pivotal trial outcome. One of those trials was EV-201, and based on the positive results, we are increasing our expectations for expenses.

We now expect 2019 R&D expenses to be in the range of $650 million to $700 million, and that SG&A expenses for the year will be in the range of $300 million to $335 million. These increases reflect the clinical development activities for EV as well as launch preparation activities of our late-stage assets. Our other guidance remains unchanged.

Now I'll turn the call over to Roger.

Roger Dansey -- Senior Key Executive

Thanks, Todd, and good afternoon, everyone. As Clay indicated, exciting results from the EV-201 trial in previously treated metastatic urothelial cancer patients support our plans to submit a BLA this year. Among patients who received both the platinum regimen and a PD-1 or PD-L1 inhibitor, the confirmed objective response rate was 44%.

And the duration of response was consistent with that recently reported from the Phase I trial. From a safety perspective, the most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and peripheral neuropathy. The BLA submission is a priority and our clinical development and regulatory teams are working together with our partner at Astellas to rapidly achieve this important objective.

We continue to work on expanding the clinical development plan for this highly active ADC in urothelial cancer. We are still enrolling a second cohort of the EV-201 trial of metastatic urothelial cancer patients who received the PD-1 or PD-L1 treatment but our platinum-naive and ineligible to platinum. This is also a population with a high unmet need. In addition, the confirmatory trial EV-301 is enrolling in the same population as EV-201 cohort 1 and is well under way.

Importantly, we are also conducting the EV-103 trial, which combines EV with pembrolizumab and/or platinum chemotherapy in the first-line metastatic setting. The positive EV-201 top line data have also opened the door to other opportunities for EV that we and Astellas are considering for the development, including in other solid tumors.

Next, I'll return to ADCETRIS. We continue to work on ensuring that the medical community is educated on the E1 study, including the updated data presented at ASH in 2018. These data show that with extended follow-up, the PFS benefit for ADCETRIS plus AVD was maintained and the peripheral neuropathy continued to resolve.

We are communicating the outcomes of E1 by interim PET status as we think this is also important information for oncologists. ABVD is frequently modified in clinical practice using an end-of-cycle 2 PET-adapted approach to either reduce the potential for lung injury from exposure to bleomycin or escalate the intensity of chemotherapy if needed due to lack of response. The ADCETRIS plus AVD regiment E1 did not contain bleomycin and was not adapted by PET status.

While cross-trial comparisons have their limitations, the data from E1 appear to be better in similar patient populations then, for example, the PET-adapted RATHL trial. Related to the NCCN Hodgkin lymphoma guidelines, ADCETRIS combined with bendamustine or with Opdivo is now listed as specific regimens in the second-line setting. The availability of these combination regimens are important for patients as they provide well-tolerated and effective options for outpatient-based salvage therapy.

Another update to the guideline is in frontline Hodgkin lymphoma where ADCETRIS combined with dacarbazine is now listed as a treatment option for patients over the age of 60 with either Stage I or II unfavorable disease and for all Stage III and IV patients. We believe this is also an important addition as it recognizes the value of ADCETRIS in a failed and difficult-to-treat population that is traditionally associated with poor outcomes.

Another area we're focused for ADCETRIS is its potential for the new development opportunities. ADCETRIS is part of various combination regimens, has been shown to be highly active in a number of settings in Hodgkin lymphoma and diffuse large B-cell lymphoma. We are now evaluating several trial designs that could support ADCETRIS label expansion and/or result in practice-informing data sets. We'll keep you posted as these plans mature.

I'll now move on to our 2 pivotal-state programs, tucatinib and tisotumab vedotin. Tucatinib is an oral tyrosine kinase inhibitor that targets HER2. The primary focus of this program is a randomized pivotal trial called HER2CLIMB in HER2-positive metastatic breast cancer, including patients with brain metastasis. We announced earlier this year that we've enrolled 480 patients in HER2CLIMB, which will support analysis of the PFS primary endpoint.

Today, we announced the target enrollment of 600 patients for HER2CLIMB has been range. As a reminder, the increased trial size strengthens the analysis of the key secondary endpoints, which are overall survival in the entire study and PFS in patients with brain metastasis.

These will be important additional endpoints in assessing how tucatinib may help patients in need. We believe tucatinib has the potential to be a best-in-class HER2 TKI. HER2CLIMB has rapidly advanced, and we are looking forward to reporting data later this year.

Tisotumab vedotin or TV is an ADC that we are developing in partnership with Genmab. We are conducting a pivotal Phase II single-arm, single-agent trial for women with recurrent or metastatic cervical cancer, which has recently completed enrollment and is designed to support a regulatory submission under the FDA's accelerated approval mechanism. The primary endpoint of this trial is confirmed objective response rate by independent review.

Updated data from the Phase I trial were recently reported at the Society of Gynecologic Oncology annual meeting showing a 22% confirmed objective response rate by independent review with a medium duration of response of 6 months. The safety profile of TV was as previously reported. We remain encouraged by the data in this setting where there is no standard of care and outcomes are poor. We and Genmab are also evaluating TV in combination with other agents to inform our strategy of moving TV into earlier lines of cervical cancer. Further, we are enrolling patients in trials of TV with other solid tumors.

Beyond our late-stage portfolio, we are advancing several other targeted therapies for cancer. This includes ladiratuzumab vedotin, which is in multiple trials for triple-negative breast cancer, including in combination with pembrolizumab. In addition, we expect to submit several more INDs during 2019 and 2020 for other agents.

For example, at AACR earlier this month, we presented pre-clinical data on SGN-CD228A, a novel auristatin-based ADC for solid tumors. The data showed antitumor activity on several models, including melanoma and non-small cell lung cancer. We expect to initiate the first Phase I trial of this agent in 2019 after IND approval.

With that, I'll turn the call back over to Clay.

Clay Siegall -- Chief Executive Officer

Thanks, Roger. Before we open the line for questions, I'll recap the key upcoming activities across our portfolio. First, continue establishing ADCETRIS as a standard of care in frontline Hodgkin lymphoma and frontline PTCL. Second, report full results from EV pivotal trial in urothelial cancer at ASCO in June and submit the BLA to FDA this year.

Third, report top line data from the tucatinib pivotal trial, HER2CLIMB in 2019. And lastly, advance the pivotal trial of TV in cervical cancer, which is now fully enrolled. At this point, we'll open the line for Q&A. Operator, please open the call for questions.


(Operator Instructions) Our first question will come from Michael Schmidt with Guggenheim.

Michael Schmidt -- Guggenheim -- Analyst

Clay, could you maybe comment a little bit more on the ADCETRIS sales in the first quarter and through the dynamics relative to the fourth quarter figure in terms of organic growth and then contribution of ordering patterns? Can you just help us understand those dynamics a little bit better?

Clay Siegall -- Chief Executive Officer

Well, sure, I could comment on. Let me start by saying that ADCETRIS is a remarkable drug that patients and doctors really depend on. First of all, there is a typical softness in sales in the first quarter. And we've seen this pretty much every year and you see it in other oncology products as well. But what I could say is in January, the sales were lower and higher in February and higher in March, and we've had a really strong April.

So I think when you look at month to month to month, we're really feeling good about where it's going through time. Second of all, please note that as we've mentioned many times that ADCETRIS is -- in frontline, is coming up against entrenched standard of care that have been around for 40 years. So it does take time. And the third thing that I'll mention, maybe you didn't ask, but we also discussed the very recent NCCN changes and these we think will be important going forward.

Michael Schmidt -- Guggenheim -- Analyst

And then could you -- a question on HER2CLIMB. You mentioned the study is now fully enrolled. Just a question on potentially filing time lines here. Would you anticipate filing potentially based on the initial PFS data set and then submitting the OS analysis later on? Or would potentially have to wait for the full data set to read out, including secondary endpoints for potential filing assuming success, obviously?

Clay Siegall -- Chief Executive Officer

These are a really, really good questions that we talk about internally. I mean some of what you asked is confidential to what we're doing, but I'll turn it over to Roger to give you a little bit of color on how we're thinking about HER2CLIMB with the caveat that we can't answer all of what you're saying at this point, Michael.

Roger Dansey -- Senior Key Executive

So thanks, Clay. So as you pointed out, the primary endpoint PFS is on the entire population, and we 2 key secondary endpoints, PFS in patients with brain metastases and overall survival. I mean in general, in a clinical trial circumstance, the primary endpoint is the key focus of the trial.

And so readouts and plans that one would make around if a trial is positive, what would a defining approach look like is focused primarily on the primary endpoint. Although the secondary endpoint is obviously very important to have as well. So without giving any specifics around what we're doing, that's sort of general guidance. Hopefully, it's of some help.


Our next question comes from Kennen MacKay with RBC Capital Markets.

Kennen MacKay -- RBC Capital Markets -- Analyst

Another one on ADCETRIS and the guidance. I guess just looking at the guidance, it seems like throughout the rest of 2019, we're going to need quarter-over-quarter growth somewhere from 5% to 10% or 11% to reach the low and high end of guidance respectively?

And I guess thinking about the quarter-over-quarter growth we saw from Q4 to Q1, can you help us understand sort of where this is going to come from? I guess it's hard for me to really conceptualize how much of Q1 was just sort of order timing impact, especially when there was a price benefit that came throughout the quarter.

And then beyond that, I was wondering if you would help us understand what is sort of going on in the relapsed/refractory Hodgkin setting with the NCCN Guideline changes midyear and last year, it seems like there's potential for some clinicians to sequence checkpoints in front of ADCETRIS? Is that something that is, sort of, taking place? Obviously, the standard of care there is going to change within the next couple of years, but any color as to commercially what's happening would be super helpful?

Clay Siegall -- Chief Executive Officer

Sure. It's a bunch of questions there; I'll try to take as I heard them. So as far as the sales and our guidance, look, we feel that this quarter-over-quarter -- I mean, excuse me, month-over-month change in the sales has been very important, and it does matter a lot of history and matches a lot of other cancer drugs, which they have some seasonality right after the holiday. So I wouldn't get too wrapped up in it.

I mean we did not provide quarterly guidance. We provided an annual guidance that we feel that we can hit, and we feel that the growth is tracking well. The E2 launch is going well. We hear from a lot of docs for this, but we're only one quarter outed to that. So it's early.

We have more data coming out at ASCO on watching E1 age and it's -- the data is a strong. And so all of that is something that we really feel is good. But going to the guidelines, the NCCN Guidelines initially were more restrictive than the label.

And -- but the committee of doctors has -- literally a couple of weeks ago, has made changes that can open the previous limitations that were there for some doctors and some pathways to write prescriptions because it now more closely matches the label, which is what the case is for E2 but for E1 had never really matched a label.

But now it's much closer as of the few weeks ago. So we think that, that's something that's very important to get out there, talking to doctors and talking to pathways. So that's a complete new thing for us to work on.

And -- but we're really excited with what we see as the growth of the product with doctors and their happiness in using it and helping patients. As far as the price specifics you mentioned, I'll turn that over to Todd to talk a little bit about the price benefit in some specifics. And then Todd you could turn it back to me to talk about the last question.

Todd Simpson -- Chief Financial Officer

Great. Thanks, Clay. Kennen, good question. So I did want to give a little bit more color on the price increase. We did have a price increase in January, but when you look at growth in the quarter, it was predominantly all volume-based.

And while that may sound a little bit unusual, maybe I can give a little bit more color around that point. A substantial part of ADCETRIS business is covered under PHS pricing. When we do a price increase, the PHS price is limited to the rate of inflation.

So we actually see very little of the price increase come through into net sales as it relates to the PHS part of business. What we saw in Q1 was a little bit of a shift in the mix of business, a little bit more PHS ordering in the quarter.

So while we did have a price increase, we didn't see a lot of that come through in the form of a sales driver. And again, most of the increase for the quarter, in fact, the vast majority of the increase was all volume-based. And we think that bodes well for how we're doing with the drug.

Clay Siegall -- Chief Executive Officer

Thanks, Todd. And going to your saying about -- questions about relapsed/refractory Hodgkin lymphoma and checkpoints and it was a conglomeration of question. What I could tell you in the new guidelines, which really are important, you have ADCETRIS plus nivolumab, which is for the first time, only a few weeks ago, is now listed in guidelines. And in fact, previously, the guidelines called out ADCETRIS plus chemotherapy, but it was a little fuzzy. And in the newest guidelines of a few weeks ago, it specifically states ADCETRIS plus bendamustine.

And let me just remind you, ADCETRIS plus bendamustine in the relapsed patients has an overall response rate of 93% with a CR rate of 74%, real truly amazing data. And ADCETRIS plus nivolumab has also an overall response rate of 93% and a CR rate of 80% and better tolerated than any bendamustine regimen.

So you have 2 choices to use, and it kind of takes the whole concept of do you choose a single agent there and you sequence them and how does it work to be why not get the highest response rate and the highest CR rate that you can get.

And with ORRs at 93%, it certainly makes sense for doctors to take a look at that. And now just recently, it's in the guidelines. And so that's something that's really important for the relapsed/refractory patient to consider.

Kennen MacKay -- RBC Capital Markets -- Analyst

Super helpful. One ultra-quick follow-up. Just wondering on the EV filing in bladder cancer, just wondering if you could help us understand what the gating factor is for filings here. And what point we might have a little bit more precision on when we might expect a filing here? Looking forward to that data at ASCO.

Clay Siegall -- Chief Executive Officer

Yes. We are working really hard on EV. EV -- I will tell you something. EV is a very important drug for us. And it is -- it's the real deal. This is a special drug and can really help patients. The number of doctors that contact us is a lot. They want -- all the doctors want to be involved with this drug. And so we're working really hard on EV-201 to get that submitted. It is the first time this will be submitted.

So it's not a second or third level. So all of the CMC and the manufacturing needs to be included in this one in a way that's different when you have a fourth or fifth or third label or whatever that we've had with ADCETRIS.

So this one takes a little longer to put together. But we are working really hard on it. We're very confident with what we're doing and at the same time, have a very big development plan with EV that's going on. So this year is what we're saying for submitting.


Our next question comes from Cory Kasimov with JPMorgan.

Matthew Thomas Holt -- JP Morgan Chase & Co, Research Division -- Analyst

This is Matthew on for Cory. First on ADCETRIS, I'm curious how you would characterize what you're seeing in terms of physicians prescribing that, depth versus reaching out to more physicians than Q1.

Clay Siegall -- Chief Executive Officer

You know what, it was a little fuzzy, the question. Can you state it one more time? You're asking about ADCETRIS prescribing, I didn't hear that.

Matthew Thomas Holt -- JP Morgan Chase & Co, Research Division -- Analyst

Yes, just wondering how you would characterize physician prescribing depth versus reaching more physicians than Q1.

Clay Siegall -- Chief Executive Officer

Okay. I will say that we keep on seeing more docs prescribing here. So we have not yet had every hematologist prescribe ADCETRIS. It's kind of -- even though it's been out there for a few years, some docs refer out the late-stage patients.

And so we're seeing more and more docs come in that -- treating the frontline. So it's really great to continue to see the depth of doctors using ADCETRIS growing. And that's something we're excited about that we've seen in Q1 and have seen every quarter since the data came out.

Matthew Thomas Holt -- JP Morgan Chase & Co, Research Division -- Analyst

Got it. And then on -- just quickly on EV. You mentioned that docs have been calling you and been pretty positive on the top line data. But what are they looking to see in the full data presentation at ASCO?

Clay Siegall -- Chief Executive Officer

Thank you for the question. So we have to reserve a lot of data for the principal investigators that worked on EV to present their data at ASCO. And it was important also for the conference for them to have a lot of data. So there will be a substantial amount of data that is released.

And I think that while the top line data of the 44% is out there, there is substantial other data that you can look at that includes other efficacies and CR rates and waterfall plots and safety parameters and all sorts of things that you'll see in the data. So I really would encourage you to listen in.

We got an oral presentation in the big section for the appropriate diseases. We're really thrilled with where ASCO put us and looking forward also to making sure we get the publication of these data out in a peer-review journal.

So I'm very pleased with what's going on with EV-201. And I just may add that we look forward to, later this year, also putting out data of the combination of EV with checkpoint inhibitors. And that's something we're really very keen on and you'll hear more about that.


Our next question comes from Geoff Meacham with Barclays.

Geoff Meacham -- Barclays -- Analyst

I just got a couple. Clay, you mentioned seeing good month-over-month growth trends. Can you talk a little bit about where you are PTCL versus Hodgkin's just with respect to sequential growth? And beyond guidelines, are there any other external threats that you think could help impact the ADCETRIS' trajectory for the balance of the year? And then I have a follow-up.

Clay Siegall -- Chief Executive Officer

So we don't really break out the Hodgkin's from PTCL, if that's what you're asking. I do understand that we look at it internally, but that's not something we report. But we continue to see growth in both areas and expect that growth will continue there.

I think the guidelines is quite important to us. We certainly have provided a lot of data and information to guidelines committees there. And to get the guidelines to be more closely matching the label is something that we have certainly been aspiring to work toward. And this just happened recently.

We're very pleased with that. We think it's the right thing for docs and right thing for patients that the guidelines more closely mimic the label. And so we think that, that is really good. As far as you asked the question should we expect more for the rest of the year, the committee meets once a year and they're going to meet later this year, and I can't speculate at whether the committee will do anything more.

The committee sometimes for these kind of things, they ask us to provide them data, and we provide them with data. I think that the aging of E1 is only to the benefit, and we continue to present that as it gets longer and longer.

And the last time I looked at data, and we presented some data at ASH, you saw the Kaplan-Meier curves get even better when you look at over longer time period. And so I think our data, as its maturing, is improving. And that's a really important factor here. Because as you with E2, we had OS, but with E1, we have not reached OS yet.

So as our data matures, doctors will look at this, and I've heard them say that is important for them because Hodgkin lymphoma is a potentially curable disease in a pretty substantial quantity of patients that get chemotherapy and to have longer time in seeing how the Kaplan-Meiers are improving for the ADCETRIS continuing regimen really gives doctors a lot of comfort to use it more and more in their patients. So we see that and we feel that and we're working on that and presenting the data.

Geoff Meacham -- Barclays -- Analyst

That's helpful. And then on tucatinib, clearly you're making progress in breast cancer with enrollment, but I just want to get your updated view outside of breast. I think CASCADE originally had some data in colon or perhaps other HER2 tumors, but I wasn't sure where you were with that.

Clay Siegall -- Chief Executive Officer

Indeed, we do. Roger, do you want to touch on that?

Roger Dansey -- Senior Key Executive

Sure, Clay, thanks. So you're correct. The whole HER2 signaling pathway is of relevance where HER2 is overexpressed including in diseases like CRC and gastric cancer. And we're obviously very interested in exploring the role of tucatinib in those 2 diseases.

So there is an investigator-initiated trial ongoing looking at CLC. There's the possibility that we may have data available some time later this year, which we think will be important in order to understand what else tucatinib may be able to do.

And we are looking carefully at gastric cancer and thinking about what a development plan could potentially look like in that disease, beyond that, even with the whole question of HER2 mutants. So there are lot of opportunities for us to explore tucatinib further.


Our next question comes from Salveen Richter with Goldman Sachs.

Andrea R. Tan -- Goldman Sachs Group Inc -- Analyst

This is Andrea on for Salveen. Maybe first with regards to the sales force that you're envisioning for EV as you launch, can you provide some additional color on how you think that buildup might progress as you move from what has traditionally been indications in blood cancers to solid tumors and then I have a follow-up.

Clay Siegall -- Chief Executive Officer

Thank you very much for the question. So EV, as I mentioned before, it is a very important drug to us -- for us and the data is just -- is strong. And so it's really -- it's remarkable. I mean it's better data when you look at what other drugs have been used for patients that have seen that are relapsed patients or refractory patients, the 44% objective response rate is way above anything else.

So it's really unprecedented data in the relapsed setting in that area. So based on that, we are going full force on building the sales for EV. We have a lead person that's in charge of that sales force that reports into our top commercial person and that buildup is happening now.

We're going to bring in fantastic people like we've done with ADCETRIS. And we're going to really grow and build this sales force. So that by the time we're ready to launch this product, we will have all of the boots on the ground and we'll be cranking forward.

And I'll remind you this is a collaboration with Astellas, and we're working very closely with them on all of the commercial aspects as well. And just in case you're wondering we -- to remind everyone, this drug is a 50-50 around the globe with Astellas. Todd, would you like to add something?

Todd Simpson -- Chief Financial Officer

Yes. So maybe just to give a little bit more color on how we're thinking about commercialization there. As I mentioned in the guidance update, there are some preparatory activities that we have under way.

We think that the commercial infrastructure that we've built for ADCETRIS can be leveraged, to a large degree, as far as things like distribution and just leadership, that type of thing. But with respect to a sales force, we do envision it being a completely separate sales force. We want to lead the ADCETRIS team solely devoted to ADCETRIS and then build a separate sales team for EV.

And I think with respect to timing, what you should expect and the way we're thinking about it is, once we see what the BLA submission time line looks like and get some insights into what kind of a PDUFA date might look like, then we'll start to become more active on the broader build on the sales team. Clay was right, we're doing some of the leadership pieces now, but the real boots on the ground would be pending more of a clear look at the submission time line.

Andrea R. Tan -- Goldman Sachs Group Inc -- Analyst

Okay. And then just one on tucatinib. Can you help us think about the opportunity there just in the context of a number of other competitors' agents that also target HER2 having shown positive benefits?

Roger Dansey -- Senior Key Executive

Sure. Yes, thanks for the question. It's Roger here. So bear in mind, tucatinib is an oral small molecule TKI inhibitor and it's taken obviously orally. The competitors that you're referring to I think are the other TKIs, neratinib, lapatinib, we do thing we have a best-in-class HER2 TKI. So depending on how HER2 claim plays out, we may be able to make that argument very clearly.

Other molecules such as margetuximab where we will see some data at ASCO is essentially a better form of trastuzumab. And so from a, sort of, direct competitor perspective, we would see it more as a potential combination approach rather than a direct competitor.


Our next question comes from Andrew Berens with SVB.

Andrew Berens -- SVB Leerink -- Analyst

Just another question on the guidelines. When I look at the revised guidelines relative to the previous ones, one of the issues I thought with the previous guidelines was it really didn't recognize that ADCETRIS substitution follow-on had an efficacy benefit. And I'm still -- I'm looking at this revision and it still lists the ABVD regimen as preferred and the other regimens, including BEACOPP and the A+AVD regimen as useful in certain circumstances.

So I still just don't get that sense what the doctors are going to see this as a potential to get better efficacy to mimic what you guys saw in ECHELON-1. So I just was wondering how you can get the message to the doctors that this is not just a drug to use in patients that have lung disease or don't have neuropathy and get a -- seen as the preferred regimen.

Clay Siegall -- Chief Executive Officer

Roger, do you want to comment on the guidelines?

Roger Dansey -- Senior Key Executive

Sure. So the wording has changed. And it's pretty clear that the description in the earlier -- in the prior version was a definition of what patients represent category 2A. And the wording was such that it appeared as though you had to have multiple conditions in place in order to be considered a 2A. So had to have no neuropathy plus IPS greater than 4 or bleomycin contraindicated.

The wording now is much clearer. It states that category 2A in select patients, for example, no known neuropathy or IPS greater than 4 or bleomycin contraindicated. So the wording really shifts the definition of category 2A more clearly into there's no known neuropathy group.

And of course patients with Hodgkin's lymphoma are generally younger people and at diagnosis in an untreated stage are likely to have neuropathy. So it obviously is a subtlety around the difference between category 2B and 2A, nevertheless, it's a very important difference in regard to the guidelines indicating unanimous agreement around the recommendation.

Clay Siegall -- Chief Executive Officer

And I will add that there is a lot of patients with Hodgkin lymphoma are under groups that proscribe to certain pathways. And when you look at certain pathways, if you're not a 2A, then a lot of pathways discourage use for a variety of reasons.

And so doctors are hesitant to use it when it is not a 2A. And this opens up the vast majority of patients now for 2A. So it's a big difference from what we've had. And this is within 2 weeks old. And so we're just now to get out there and it really has the potential to impact the pathways and the log jam that we had with various groups.

Andrew Berens -- SVB Leerink -- Analyst

All right. Well, I mean it's definitely an improvement, but what's going to take to get it to the preferred treatment for it to reflect that, there's actually an efficacy benefit if you substitute A+AVD? I just wonder when I look at this, the preferred regimen of the ABVD for two cycles and then you restage and then there's 3 branches, which could include A+AVD for support cycles or the other 2 options in chemotherapy. And I just wonder if the reason of the guidelines are not recognizing the full benefit that ECHELON-1 has because it wasn't compared to one of these other branches in the tree.

Clay Siegall -- Chief Executive Officer

You're asking some really good questions, and over time, guidelines can change, and we just saw a change in guideline. We remained very excited about our data. There is no doubt that ADCETRIS AVD is a better regimen for patients. And you get -- you don't have the bleomycin toxicity and you get a higher efficacy.

And as we track this longer and longer, we get even better efficacy. So it is -- there is no doubt to us that ADCETRIS AVD is the best regimen. What we're talking about is entrenched 40-year regimens by doctors who a lot of these people making the rules are the same doctors that did these trials and put it together.

And so it is a -- it is -- you're up against something that when we started and said, we're going to improve frontline Hodgkin lymphoma and get a higher cure rate without the deaths and toxicity associated with bleomycin, there were some folks who said why you're doing this, Hodgkin lymphoma is cured in everybody, which is not true.

There are a lot of patients where it's not cured and a lot of patients suffer the side effects. Some patients die from the side effects. And the more docs we get out there, the more docs are convinced to use ADCETRIS AVD. So we are working along this entrenched pathway and making really good progress.

Andrew Berens -- SVB Leerink -- Analyst

Okay. Is there any plans to expand the sales force to reach the community docs more? And what percentage of the community docs have been detailed on the ECHELON-1 results?

Clay Siegall -- Chief Executive Officer

Thank you for the question. We actually expanded our sales force when we went into and got frontline approval. So we added another 50% to the sales force. We think that our sales force now -- with our enhanced sales force is the right size.

We feel that we are detailing the community docs and the academic docs as much as possible. As you know, there is a lot of roadblocks to detailing with docs these days. It's not as easy that it used to be to get out in their office, get their time, get their attention. We've been doing a lot of different things.

One of the things that's pretty darn effective is hosting regional dinners with key opinion leaders coming to give talks about what the data are with Hodgkin lymphoma and when docs hear key opinion leaders talk about the data and they talk about the benefits of ADCETRIS-containing regimen, we see improved ordering because they're helping patients.

So we need to continue doing the best we can do to get out into the field with the appropriate and compliant ways of doing it in 2019 and beyond because these compliance rules of talking to docs change all the time. And they're making it really tough to talk to docs in a way that it used to. But we're getting through that. We have a lot of great things going on. And the other thing that we've been working really hard is the whole digital approach.

We're increasing our focus on digital because patients come in and especially these young people, which is a big chunk of Hodgkin lymphoma, and they go right to the Internet. They want to know what's going on.

And so we're increasing our focus on banner ads and social media advertisements and media placements to get the people that go online to go on and see the data and look at the data. And those people, they talk to their docs about this.

And what we hear it from the docs, they like that, they like the patient take some activity and looks at the data. And they like to have that discussion with patients when patients are informed of the newest data. So this is something that we're really adding a lot of focus to.


Our next question comes from Tazeen Ahmad with Bank of America.

Tazeen Ahmad -- Bank of Merrill Lynch, Research Division -- Analyst

Clay, a couple for you. You said at the beginning of the call that the beginning of the year was impacted by seasonality. I was wondering if you could provide a little bit more color on what the drivers of that seasonality might be.

And then to follow up on your comments about the collaborations and upcoming data with some of your partners including GSK, for example, could you give us a sense, based on what you know about the indications being studied, that which of them could potentially have the most impact in terms of payments to SGN over time? And then I have a follow-up for Todd on financials.

Clay Siegall -- Chief Executive Officer

Yes. So we see the seasonality event happening pretty much every year. Hodgkin lymphoma is not a superfast moving disease like some diseases are. And if you're not feeling well and you have night sweats or fever and you go to your doc, you don't know necessarily of Hodgkin lymphoma or if you're just diagnosed with Hodgkin lymphoma, you may decide to delay treatment until after the holiday.

So you first start coming in perhaps sometime in January for even your first dose. So it can delay your treatment and that way you could spend the holidays with your family. And it's just something you could see in a more slow-moving tumor than some of the more rapid ones where you got to hop on it that minute.

So we do see the seasonality. It's something we see over and over and over from year to year. So it was not surprising to us to see February being better than January and March better than February and April being very strong. So we're really happy with what we're seeing right now. Onto the collaborations, you brought up GSK.

GSK has some fantastic data in multiple myeloma with their BCMA antibody drug conjugate. What we hear from them is they're planning to submit in the second half of this year. And we're delighted through the impact in multiple myeloma.

That is a potential large market. And they also are doing many other trials, including frontline. And so that potentially could be a really big drug for GSK and really beneficial to patients and to Seattle Genetics.

The other two collaborator drugs that we pointed out in our prepared remarks included Genentech/Roche with polatuzumab for non-Hodgkin lymphoma and that is likely -- to me, likely to get approved this year. Their PDUFA date is August.

The data that they have is fantastic. And I was very impressive with the data. And they're also doing frontline trial. So both GSK and Genentech are looking toward getting their first approvals in the relapsed setting but then moving into frontline with ongoing trials. So it's not just hand waiving. It's very exciting to see what these 2 drug conjugates can do in patients.

And lastly, AbbVie, they have a glioblastoma drug. They put out their numbers this morning and on their conference call talked about this drug for glioblastoma and their excitement level with it. So that's something that you should definitely keep on the lookout for when AbbVie releases data from their Phase III trial.

Tazeen Ahmad -- Bank of Merrill Lynch, Research Division -- Analyst

Okay. And then Todd, you talked about the changes that you expect for expenses heading into the rest of the year with regards to R&D. Can you directionally give us a sense on what proportion of your spend in R&D is going to be for your late-stage trials versus your early pipeline expirations? And then can you just give us a sense of what the cash runway is based on where you are today?

Todd Simpson -- Chief Financial Officer

Sure. So with respect to late versus early, I think, as probably you would expect, the late-stage programs have advanced quite nicely with multiple drugs in pivotal studies. So without getting into a specific allocation of what gets spent by program, you can rest assured that the lion share of the investment is in late-stage programs.

ADCETRIS continues to actually be fairly significant area of spent for us. EV I, think, will be cranking up now with the very positive results we saw from the 201 study. Tucatinib has been a big program and will continue throughout the year.

And then drugs like LV and TV are cranking along as well. TV, we just recently announced that the pivotal study has been fully enrolled. So we're very focused in the late-stage pipeline. But I think as we've talked about before, there's also a deep pipeline of other assets in technology that we continue to look at.

So we don't only invest in late-stage, we're trying to keep the pipeline full as well. And then with respect to cash runway, the company continues to be in a really strong position. ADCETRIS is a strong base of business for us through not only our sales in the U.S. and Canada, but through the royalties that we receive from Takeda.

So that continues to really provide a lot of fuel for the engine, so to speak. And we have a strong cash position. We ended the quarter with about $420 million on the balance sheet. That doesn't include obviously the investment we have in Immunomedics, which is about another $140 million to $150 million. So we feel really good about where we are even with the added burn and feel that we're well positioned to continue really aggressively pushing all of our programs forward.


Our next question comes from Stephen Willey with Stifel.

Stephen Douglas Willey -- Stifel, Nicolaus & Company -- Analyst

I know it's early in terms of PTCL but just kind of wondering if you could maybe characterize some of the initial commercial dynamics you're seeing there, specifically with respect to utilization in some of those subtypes beyond ALCL. And then I have a follow-up.

Clay Siegall -- Chief Executive Officer

Yes. Thanks for the question. We hear really good things about the use of ADCETRIS to the E2 regimen and all the different subtypes. We're not hearing that docs are not using it in certain areas. That's just not what we're hearing. I do want to say that for the E2 regimen, and we've previously said this, that the number of cycles that a patient gets is a little less than E1 regimen.

And they're just based on how they're treated and in our protocol, there's always less cycles. So the standard patient with E2 is less financial -- less of a payment for the drug than it is for E1. So that's something -- it's about 20-or-so percent less, something like that per patient. But it depends certainly on their size. So that is something just to point out that they're not exactly equivalent. And you have another question?

Stephen Douglas Willey -- Stifel, Nicolaus & Company -- Analyst

Yes. So I know retreatment with ADCETRIS appears to be a fairly well-accepted concept within the realm of Hodgkin's. But just wondering if you think this is a phenomenon that we'll see play out over time in PTCL? And I guess, how you're thinking about the legacy relapsed/refractory sales you're generating in ALCL?

Clay Siegall -- Chief Executive Officer

Sure. Retreatment with ADCETRIS works really well. I mean we have data -- early on we had data that showed 70% retreatment reresponse rate and that was in Hodgkin lymphoma. And I hear from docs that they feel comfortable in using ADCETRIS in retreatment.

One of the things that happened was when we first got approval, we had a cap of how many cycles of ADCETRIS could be used in a patient. And that was in 2011. But when -- as we provided more data to regulators, only a few years after that, they removed the cap. So I think that was in 2013 or '14, they removed the cap on the use of ADCETRIS.

So it's capped to 1 year of potential use. You can now use ADCETRIS as you see -- as the doctor sees fit, much like how they use Rituxan. They treat with Rituxan and then they come up with another regimen and come up with another regimen. And we've shown that, that can be very valuable for patients. So we feel very good about retreatment. And you had another -- I forget the second part of your question.

Stephen Douglas Willey -- Stifel, Nicolaus & Company -- Analyst

No, that was it.


Our next question comes from Shanshan Xu with Berenberg Capital Markets.

Shanshan Xu -- Berenberg -- Analyst

I think you have talked about the North American subgroup analysis of ECHELON-1 quite a bit in the past. I'm just curious that you published another subgroup analysis on AYA, adolescent and young adult patients in which actually the risk reduction for the traditional PFS is 40%, and that was in 2018 ASH.

This is a very impressive data and I'm wondering if there's any ongoing effort to promote this AYA data in the medical community, given that the younger patients will probably tolerate ADCETRIS better and they receive additional survival benefit from it. And could this become another tailwind for ADCETRIS?

Clay Siegall -- Chief Executive Officer

So first of all, thank you for seeing our data. We really are excited with our data with E1 and it proves over and over, every time you look at it, every time we age a data, looking at the North American region, looking at the young folks, the E1 regimen definitely outperforms ABVD every which way we look at it.

And so -- but showing the data in these subpopulations is not necessarily something you can promote to. So it's really good for us to get out the publications and put them in great journals. And doctors can see what we're doing and the power of the ADCETRIS-containing frontline regimens.

Shanshan Xu -- Berenberg -- Analyst

Another forming is that I would like to touch briefly upon EV-103. So this is a combination trial in the first-line you see with cisplatin or carboplatin. So given that EV is essentially a chemotherapy, actually with -- obviously with the GPS with the navigation, so how should we think about the tolerability and toxicity profile for the combination of chemotherapy together with EV?

Clay Siegall -- Chief Executive Officer

So first of all, when you think about EV-103, it has a couple of different groups in there. First of all, and probably the most important of the groups in EV-103 is EV plus pembrolizumab or KEYTRUDA, as it's called.

And that subgroup is the one we have been focused on the most. And that's the subgroup where we think that we've been collecting a lot of data in substantive amount of patients. And I think there's a decent chance we will present those data later this year. So stay tuned for the group of EV-103, arguably the most important with EV and pembrolizumab.

In that same trial, there's also an arm that's EV plus a platinum. And that's something that we wanted to look at -- largely to look at what the safety is because we've never really put those 2 together. And the reason is, we may also look -- or also contemplated in EV-103 is putting a platinum regimen plus a checkpoint plus EV together in a triplet.

So that's also contemplated in that, in EV-103. And that is because there are quite a few companies now doing trials in the frontline combining checkpoints with platinum regimens. And so we wanted to be prepared for whichever way this goes, our first approval is going to be what we're submitting for EV-201 is in patients that have been exposed to both a platinum and a checkpoint. And so that's initially.

But as we go toward frontline, it is really important to know all the parameters, all the components -- what the components bring forward and then we can make the best choice for frontline. But I'm really jazzed up about our options in frontline in the future. And Roger has a comment.

Roger Dansey -- Senior Key Executive

Sure. So on the point of combining agents, just bear in mind when you look at, for example, ADCETRIS, which has the same vedotin component as the EV molecule, we've combined ADCETRIS actually quite well, including, for example, vinblastine in the E1 program.

There is some early data with ADCETRIS looking at a platinum-containing regimen and we believe they were tolerable. So the -- obviously we have to test the safety and report out the safety and make sure that these sorts of combinations with chemotherapy are indeed tolerable and safe. But it may well be that we can get significant additive benefits combining with these agents.

As Clay indicated, I think our focus is heavily weighted toward the PD-1, but we do need to understand what EV looks like, both from a safety and then from an efficacy perspective, when we look at the other agents that are commonly used in bladder cancer such that if any particular combination looks particularly favorable and has an acceptable safety profile, that's something we can take forward.


Our next question comes from Silvan Tuerkcan with Oppenheimer.

Silvan Tuerkcan -- Oppenheimer -- Analyst

You already touched on treatment options in breast cancer a bit, but I want to ask about the since being renewed interest in HER2 targeting ADCs, I think Roche is working on one. And there was a deal between AstraZeneca and Daiichi. Could you just let us know what potential differentiators are there between the different ADCs targeting HER2 plus?

Clay Siegall -- Chief Executive Officer

Well, that's sort of a question outside a little bit of Seattle Genetics, if you will. And what I would tell you is, TDM-1 seems to be a very important drug and helps a lot of patients. And if used in patients with HER2-positive breast cancer along with -- I mean trastuzumab or Herceptin is used same way the PERJETA or -- and same way the TDM-1.

So there's really a suit that Genentech/Roche sells of HER2-targeted agents. I think that the Daiichi Sankyo 8201 looks very interesting. I think it can really help patients. And that's a drug that I think you should keep an eye out for. And Roche is constantly looking at HER2. So I can't comment on what they have in their pipeline.


Our next question comes from Andy Hsieh with William Blair.

Andy Hsieh -- William Blair -- Analyst

I just have a question on the second-line Hodgkin physician adoption. So probably for Roger. So in terms of ADCETRIS plus bendamustine, ADCETRIS plus nivolumab or added to the NCCN Guidelines, do you think that these regimens are mostly for ABVD upfront or be a cop upfront? Or do you think, given, I think, Steve's question earlier about retreatment, you can actually get a lot of patients from the E1 regimen to go on these 2 combinations?

Roger Dansey -- Senior Key Executive

Yes. I think the point was made earlier that retreatment with ADCETRIS appears to be vary in Hodgkin lymphoma. So in the circumstance of having initial therapies and the reasonable gap between individual therapy and follow-on treatment, ADCETRIS monotherapy is acceptable.

The ADCETRIS, as Clay indicated earlier, ADCETRIS plus bendo, ADCETRIS plus nivo, both of those outcomes, they're small data sets, but they are very encouraging results and have obviously risen to the level where the guidelines committee has considered them worthy of recommendation.

So the idea of someone, for example, getting E1 in the frontline and then having relapse and then getting reexposed to ADCETRIS, again, I think is an entirely reasonable concept, if that's what you're asking. I think you would expect that the regimen should be tolerable.

Andy Hsieh -- William Blair -- Analyst

And also -- you also emphasized the CR rates. Is that in the context of bringing these patients to transplant eventually?

Roger Dansey -- Senior Key Executive

Exactly, exactly. I think as you heard in the prepared remarks, ADCETRIS plus bendo is a tolerable regimen, ADCETRIS plus nivolumab is a tolerable regimen with remarkable results, high CR rate -- high ROR and high CR rates, which is exactly the circumstance patients need to be in as they head into transplantation. So providing obviously you need to have an outpatient salvage rate, which lines you up for a good outcome post-transplant is what we think these regimens may offer patients.

Clay Siegall -- Chief Executive Officer

Andy, if you are a Hodgkin lymphoma patient, what you want the most is to get at cure with your first treatment regimen. And what ADCETRIS offers upfront is a higher long-term disease-free survival rate than what ABVD offered. And then in that small population that's remaining, they also want to have another bite at the apple for a cure.

And what you want to do is you want to get a patient into a CR and do a transplant, if you need to go that direction. And the CR rates that we have with ADCETRIS and benda or ADCETRIS and nivo are extraordinarily high. So there are really 2 different ways you can get to cure with Hodgkin lymphoma.

And if you're a patient with Hodgkin lymphoma, you're -- you have options to get a substantial amount of these people into long-term disease-free survival. And ultimately, a lot of these patients could be cured meaning they don't die of their Hodgkin lymphoma in their lifetime.

And so could we all die of something? And so it is really exciting to me to see how ADCETRIS has redefined the landscape of how you treat Hodgkin lymphoma, and I believe we'll end up curing a lot more patients.

Andy Hsieh -- William Blair -- Analyst

Great. And just one thing. Am I correct in thinking that the manufacturing issue that was brought up during this Q4 call that's been completely resolved?

Clay Siegall -- Chief Executive Officer

I wouldn't call it manufacturing issue. We reported that we had to remake 1 batch of drug. Andy, I will tell you that we have manufactured and supplied ADCETRIS to 72 countries since 2011 without any failure to do so and working with regulators around the globe. We're pretty good at this. Todd, do you have any comments?

Todd Simpson -- Chief Financial Officer

Well, yes. I was just going to say, there wasn't a manufacturing issue, there was a quality release threshold that we didn't meet on a few batches. So we let them go. But to Clay's point, we've never had a supply interruption and that happened in Q4 didn't even put us close to that. And we have now substantially reestablished all that inventory. So we're in good shape.


And we have no further questions in the queue at this time. I would now like to turn the conference back to our presenters for any closing remarks.

Peggy Pinkston -- Head Of Corporate Communications

Okay. Thank you, operator, and thanks, everybody, for joining us this afternoon. Have a good evening.


Ladies and gentlemen, this concludes today's presentation. You may now disconnect your phone lines.

Duration: 72 minutes

Call participants:

Peggy Pinkston -- Head Of Corporate Communications

Clay Siegall -- Chief Executive Officer

Roger Dansey -- Senior Key Executive

Michael Schmidt -- Guggenheim -- Analyst

Kennen MacKay -- RBC Capital Markets -- Analyst

Todd Simpson -- Chief Financial Officer

Matthew Thomas Holt -- JP Morgan Chase & Co, Research Division -- Analyst

Geoff Meacham -- Barclays -- Analyst

Andrea R. Tan -- Goldman Sachs Group Inc -- Analyst

Andrew Berens -- SVB Leerink -- Analyst

Tazeen Ahmad -- Bank of Merrill Lynch, Research Division -- Analyst

Stephen Douglas Willey -- Stifel, Nicolaus & Company -- Analyst

Shanshan Xu -- Berenberg -- Analyst

Silvan Tuerkcan -- Oppenheimer -- Analyst

Andy Hsieh -- William Blair -- Analyst

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