Halozyme Therapeutics Inc
NASDAQ:HALO
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Halozyme Therapeutics Inc
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Good day, ladies and gentlemen and welcome to the Halozyme Investor Call. We now have all of have speakers in conference. Please be aware that your line is in listen-only mode. At the conclusion on today’s presentation, we will open the floor for questions, [Operator Instructions].
It is now my pleasure to turn the conference over Dr. Helen Torley, Dr. Torley, please begin.
Good afternoon everyone. And thank you for joining us today. Today I’m joined by Laurie Stelzer, our CFO, and Dr. Demetrius Chondros, our Chief Medical Officer. As we enter the second half of 2018, I’m pleased to share details of the strong progress and continued momentum across both of our value creating pillars.
And during this call, we will be making forward-looking statements and I refer you to our SEC filings for a listing of risks and uncertainties.
I will begin the call with the key takeaways for the quarter. Firstly, we reported yet another quarter of strong growth and enhanced outpace, we increase 36% over the second quarter of 2017, on a reported basis, or 17% adjusting for the change in accounting we implemented at the beginning of the year.
And secondly, we are making strong progress towards realizing the enhance $1 billion royalty revenue potential in 2027, that I discussed in January. This projection was based on the continued growth of our three currently marketed products and the successful development approval and launch of seven new products.
The great news is, that we expect all seven of these new products will be in the clinic by the end of this year. And I will give more details on this in just a moment.
And thirdly, our HALO-301 registration study remains on-track to achieve the target number of Progression-Free survival events, between December of 2018 and February of 2019. Enrollment is also on-track to achieve approximately 500 patients by year end.
Now with those key takeaways, let me now provide some additional color on each pillar. On enhance with license, our uPH20 Enzyme to eight leading companies to-date. As shown in Slide 2, the projected royalties for our three marketed productions plus the seven new products that are projected to be in clinical development in 2018 result in the potential for approximately $1 billion in royalty revenue in 2027.
Now this has since multiple indications and global launches and the recall that Halozyme receives on average mid single-digit royalty on that sales of ENHANZE formulated products.
Let me begin with the updated and progress in the currently marketed products. In July, we announced achievement of a major milestone, the FDA acceptance of ROCHE BLA for subcutaneous version of Herceptin and its approved breast cancer indication.
The action date is March of 2019. Upon approval, this would allow for new administration option and potential shorter treatment times for patients. What is reported 2017 U.S. sales of IV Herceptin of CHF2.7 billion. The potential royalties from a successful U.S. launch of subcutaneous Herceptin representing meaningful opportunity for Halozyme.
And Roche’s Rituxan HYCELA is subcutaneous formulation of rituximab coformulated with ENHANZE was approved by the FDA in multiple blood cancer indications in mid-2017. The commercial launch of Rituxan HYCELA continue to progress with the additional clinic initiating and driving conversion.
Roche begin piloting direct with agent strategies in July highlighting the potential benefit of replacing of Rituxan IV infusion with the five to seven minute injection suing Rituxan HYCELA.
Let's move now the seven new product that are already in clinical development or planned to enter development in 2018. I'm going to break the discussion into two parts. Firstly I will focus on four targets that have already been disclosed and then second we will focus on the three additional undisclosed targets.
If you turn now to Slide 3, if we consider the four disclosed targets shown here, together with three currently marketed products and these represent more than 60% of the $1 billion royalty revenue potential in 2027.
Excitingly two of these targets are now in Phase III clinical study deratumamab and fixed dose combination of Perjeta and Herceptin. As we have said before in our experience, a product entering Phase III testing represents a significant derisking event on the path to approval and commercialization with ENHANZE.
Focusing first on DARZALEX SC, in December of 2017 Janssen and Macey did a multiple Phase III studies of ENHANZE. This follows a presentation of data supporting a 16 milliliter injection also subcutaneous formulation delivered in five minutes or less.
Janssen is currently studying DARZALEX SC with ENHANZE and four Phase III trials in patients with multiple myeloma, amyloidosis and smoldering myeloma. In addition, the company has initiated a Phase II study of DARZALEX SC with various combination therapies in frontline and relapse refractory multiple myeloma patients.
Commercialization of the DARZALEX IV formulation continues to progress well. Reported sales were $511 million in Q2 and 18% growth from that quarter. Recall that analyst predicts peak sales of DARZALEX to exceed $7 billion with ongoing studies for the SC regimen progressing well, this program continues to play a key role in Janssen development plans for DARZALEX.
Turning now to Herceptin SC and Perjeta SC using ENHANZE. In July we announced Roche initiated a global Phase III study of fixed-dose combination following support to Phase I results from the same combination that was shared at the 2017 San Antonio Breast Cancer symposium.
The Phase III study will enroll approximately 500 patients with HER2-positive early breast cancer in the new adjuvant and adjuvant setting. Today patients receiving Perjeta IV and Herceptin IV administered sequentially can expected to take 2.5 hours for the loading dose and between 1 and 2.5 hours for subsequent doses.
With the fixed dose subcutaneous approach, the times are substantially shorter with the loading dose expected to take seven to eight minutes and subsequent doses five minutes. Roche expect to submit data from the Phase III study for approval in 2020.
The remaining two disclosed targets are first Phase Bristol-Myers nivolumab for a Phase I study, its planned to begin to begin in the third quarter. And secondly, Alexion’s ALXN1210 for a Phase I study is planned for the second half of this year.
Now we will turn to the undisclosed targets to complete those initial seven targets we discussed. These development programs include at Lilly's investigational target, which began at Phase I study in 2017. A new unnamed Roche target which began clinical testing earlier this year, and another unnamed target, which is expected to enter the clinic later this year. Each of these program is also progressing to plan.
We are really delighted with the acceleration in the number of product planned for development with all seven of these new potential product expected to be in clinical testing by the end of 2018.
And now we have some additional good news. During the first half of the year, we worked close to the Bristol-Myers Squibb for additional development target. As a result, we now have line of sight to studies for two new targets at the start in 2018, that were not in our original projection.
In the first study, Bristol-Myers will be evaluating their investigational anti-CD-73 antibody and a Phase I study to begin in the third quarter of this year. The second study which is also planned to begin in the third quarter, we evaluating currently undisclosed targets.
Our partners continue progress, quickly moving into and through the clinic is testament to the opportunity for strong competitive differentiation with ENHANZE and I look forward to sharing additional information and updates around these programs in the coming months.
At closing ENHANZE, interest in new collaboration agreements remain strong. I have confidence, we will continue to secure additional partnerships as companies look for competitive differentiation and the potential to reduce the treatment burden for patients.
While the timing of new agreements is always unpredictable, we are very excited by the potential these new agreements can represent.
I will turn now to our oncology pillar and our investigational drug PEGPH20. PEGPH20 is a targeted therapy, that temporarily degrades highly Ronan or HA that can accumulate in certain tumors and constrict the tumor vasculature.
We are studying PEGPH20 with a companion diagnostic developed with our partner Ventana to identify patients with HA high tumors and we protect them approximately $1 billion potential global opportunity in pancreas cancer alone.
On Slide 4, is an overview of our Phase III study, HALO-301, which is evaluating PEGPH20 in combination with ABRAXANE and gemcitabine in first-line pancreas cancer patients. Screening and enrollment for the study are on target and we project enrollment of approximately 500 patients by year end.
HALO-301 has two primary endpoints, progression-free survival and overall survival. Recall, an interim analysis is planned for our first primary endpoint progression-free survival, when we achieve the target number of PFS events.
We continue to predict this will occur between December of 2018, and February of 2019. Upon achieving the target number of PFS events, the next step will be final data collection and data based clean and lock. The Independent Data Monitoring Committee will conduct the interim analysis.
At that time, if the progression-free survival data show a significant benefits in the PEGPH20 treatment arm and both the overall survival and overall risk benefit are supportive, these data may form the basis for marketing application in the United States and conditional marketing authorization in Europe.
Now there is a second ongoing study evaluating the combination of PEGPH20 ABRAXANE and gemcitabine in first-line metastasis pancreas cancer patients. This is an investigator sponsored trial which has been conducted by Dr. Kenneth Hughes at the Memorial St. Catherine Cancer Center.
At this study, it's a single arm study which examined to use also of the oral anticoagulant [indiscernible] in place of using low molecular heparin injection. Data from the first part of Dr. Hughes study were presented at SPGI earlier this year and included 28 patients irrespective of HA status. Results showed that 57% overall response rate and no cases of grade 3-4 thromboembolism in an all comer population.
At the European Society for Medical Oncology Congress in October, Dr. Hughes will report updated data including data on additional patients who have been enrolled. The data will show the strong overall response rate was maintained.
A retrospective efficacy analysis based on patient AA status will also be conducted. With this encouraging data, we are continuing to access the feasibility of and a pass through achieving future regulatory labeling for the use of [indiscernible] with PEGPH20.
Now let's turn to Slide 5 and an update on our evaluation of PEGPH20 in other tumor types. Data from the Phase I portion of our clinical collaboration with Eisai evaluating PEGPH20 to Eribulin have also been accepted for presentation for the 2018 ASMO Congress.
The addition of PEGPH20 to Eribulin showed an overall response rate of 36% in the single arm trial. Now it's important is that this is double the response rate reported with single agent Eribulin in prior studies of patients with HER2-negative metastatic breast cancer. This is our first demonstration of PEGPH20 positive effects outside pancreas cancer.
Moving now to our trials and combination of checkpoint inhibitors, I will focus firstly on our study evaluating PEGPH20 plus KEYTRUDA or pembrolizumab in non-small cell lung cancer and gastric cancer.
In the non-small cell lung cancer cohort, we are evaluating PEGPH20 plus KEYTRUDA monotherapy in second line and later stage patient who have not previously been treated with the immune checkpoint inhibitor.
In June, we announced the early closing enrollment in this cohort and this was an anticipation obtained in the standard of care resulting from the recent reported studies for KEYTRUDA plus chemotherapy in frontline patients.
For the closing enrollment they totaled a total of 17 of the target 30 patients were enrolled in the expansion cohort. And while there are still three patients on treatment, I’m comfortable providing a brief update today.
All 13 currently evaluable patients four patients experienced a more than 30% reduction in tumor volume as affect by the investigator site. Two of these patients had a further scan confirming the 30% reduction was maintained.
All of the four patients experienced more than 30% reduction three were PD-L1 negative, while data is unavailable on the moment for the forth. Now acknowledging the small sample size, the reduction in tumor size in four patients, three were PD-L1 negative is start to make them treating. And we are now working with investigators and advisors to understand how to further evaluate PEGPH20 in non-small cell lung cancer given the highly competitive and dynamic environment.
Turning to the gastric cancer cohort. Earlier this year we reached enrollment of 34 patients. three patients remain ongoing in the trial and PD-L1 testing has not yet been completed. Of the current 26 evaluable patients, to-date we are seeing one responder who had PDL-1positive status. The response rate does not meet our threshold to continued development of PEGPH20 in combination with KEYTRUDA alone in gastric cancer.
Regarding our collaboration studies with Roche, we continue to make progress in the evaluation of PEGPH20 and pembrolizumab in pancreas, gastric and gallbladder cancers, as well as in cholangiocarcinoma.
In particular, we are making good progress in the dose escalation portion of the Halozyme life study in cholangiocarcinoma and gallbladder cancer. If all continues well, we would expect to began dose expansion portion of the study later this year and we will there evaluate efficacy parameters.
So in summary, we have seen encouraging efficacy results in our combination studies of PEGPH20 plus chemotherapy in pancreas and the breast cancer and encouraging data in PDL-1negative non-small cell lung cancer. We look forward to the presentation of the new data in pancreas and breast cancer at [AMO] (Ph) in October.
And finally I would like to highlight a recent development in the Halozyme intellectual property portfolio. In March the U.S. patent and trademark office granted Halozyme a passive covering the combination of PEGPH20, ABRAXANE and gemcitabine.
This is the combination being studied in our HALO-301 registration trial in pancreas cancer. Following these actions Halozyme has obtained exclusive rights to the claims combination through March of 2033, which is subject the potential for patent term extension that made for the prolong the exclusivity period and this same application is pending or has been issued in multiple countries outside the United States.
With that update, it's my pleasure to turn the call over to Laurie who will discuss our financial results in greater detail. Laurie?
Thank you, Helen. I will begin on Slide 6. When you will see that revenue for the second quarter was $35.2 million compared to $33.7 in the prior year period. Royalty revenue total $20 million an increase of 36% on an as reported basis from the second quarter of 2017, primarily driven by sales of ENHANZE products outside the U.S. with Herceptin SC continuing to be the largest contributor.
We remain encouraged by recent comments from Roche on their Q2 earnings call, indicating the subcutaneous formulations of ritoxin and Herceptin has proven to be durable and despite the impact of biosimilars to the IV version of MabThera in Europe, MabThera ST has maintained market share.
Moving down the income statement, bulk sales of rHuPH20, [indiscernible] drug product $0.7 million compared to $8.9 million in the prior year period. This reduction is the result of the plan decline in API product orders, we previously reported as our partners continue their manufacturing transition.
HYLENEX product sales totaled $3.8 million and collaboration revenue total $10.7 million including the recognition of two $5 million milestone from our ENHANZE partners.
Prior to the adoption of FASB Topic 606, we typically recognized clinical milestone payments upon the achievement of the underlying event such as the dosing of the first patient in this study., Under the new accounting standard, we are required to recognize revenue associated to a given milestone if a high likelihood for achieving that milestone exists.
As a result, we are recognizing a total of $10 million of milestone revenue in the second quarter in connection with the upcoming initiation of Bristol-Myers Squibb Phase I study of the CD-73 target with ENHANZE and the Alexion Phase I study of ALX1210 with ENHANZE.
Moving Slide 7, starting last quarter, we implemented a new process related to FASB Topic 606 for how we record royalty revenue. Prior to January, we recognized royalty revenue one quarter in arrears due to the timing difference between our financial close and when we received royalty reports from our partners.
Under the new guidance, we now estimate royalty revenue for the current reporting quarter and we will true-up this estimate to actual in the subsequent period when the royalty reports are received.
To assist in this transition, two comparisons were shown on the slide. The first table shows reported royalties for the quarter, which is our estimate of $20 million, an increase of 36% from the $14.7 million in royalty revenue we reported for the second quarter of 2017.
The second table compares our Q2 estimate of $20million to the actual royalties we received in the prior year of $17.1 million which were recorded in Q3 of 2017 under the prior methodology. This adjusted view shows growth of 17%.
To close on royalties our estimates for the second quarter royalty revenue was negatively impacted by the strength of the U.S. dollar which we calculated to be approximately $0.9 million. Adjusted for that impact, Q2 royalties were sequentially flat to $20.9 million we reported in Q1. From a year-on-year perspective, foreign exchange did not have an impact on to be as reported royalty growth of 36% from Q2, 2017.
Turning to Slide 8 for a more detailed breakdown of our P&L. Total operating expenses were $55.3 million, cost to product sales was $0.8 million in the quarter compared to $7.8 million in the prior year period driven by lower API product orders. Research and development expenses for the quarter were $40.1 million compared to $38.3 million in the second quarter of 2017.
Selling general and administrative expenses were $14.4 million compared to $13.1 million in the prior year period. Net loss for the quarter of $22.9 million or $0.16 per share compared to a net loss of $30.8 million or $0.23 per share in the second quarter of 2017. And cash and cash equivalents and marketable securities was $398.9 million at June 30, 2018 compared to $297.5 million at June 30, 2017.
Finally, I would like to update our revenue and year-end cash guidance and reiterate our other 2018 guidance ranges as shown on Slide 9. For the full-year 2018, we now expect net revenue increasing from the prior range of $115 million to $125 million to $125 million to $135 million driven by ENHANZE milestones not contemplated in our guidance from the beginning of the year.
Within the revenue line, we are maintaining our forecast for royalty growth of 25% to 30%. In addition, we continue to forecast a decline in ACI product orders as our partners continue in their manufacturing transition and currently have sufficient API and safety stock to support their near term plans. For modeling purposes, we expect the third quarter of 2018 to be consistent with Q2 and for API sales to begin to rebound by the end of the year.
We continue to expect operating expenses for 2018 of $230 million to $240 million flat to both 2017 and 2016. Operating cash burn of $75 million to $85 million, debt repayment of approximately $95 million, which includes principal and interest payments related to our royalty-backed and SVB Oxford loan.
And we are increasing our year-end cash balance from the prior range of $305 million to $315 million to a new range of $310 to $320 million. This increase is driven by the ENHANZE milestones revenue partially offset by a modest built in rHuPH20 inventory and anticipation of future partner demand.
And with that, let me turn the call back to Helen, who will provide closing comments.
Thank you Laurie. In Summary, you have just heard we executed well in the first half of 2018 and are poised to continue to generate value across the ENHANZE and PEGPH20 pillars in the second half of the year.
Highlights for ENHANZE include wealthy increasing 36% year-on-year in a reported basis. Strong progress being made with the three currently marketed products and across the seven development Phase products supporting our projection for the potential $1 billion in royalty revenue in 2027 and two new targets planned to enter clinical testing in 2018 that we are not in our initial projections from January.
And in our oncology pillar, HALO-301 execution remains strong with the target number of PFS events projected between December of 2018 and February 2019, and additional data in pancreas and breast cancer data to be presented at ESMO of 2018.
Recall, I spoke in January about the $1 billion potential for each of our pillars. As you can see, our executions throughout the first half of 2018 has reinforced and de risked these projections and I want to by expressing my ongoing - and appreciating for the talent that Halozyme team for their continued hard work as we advance our programs and support partners and patients.
We are now ready to take your questions. Operator please would you open the call?
Yes ma’am [Operator Instructions] Our first question comes Gena Wang with Barclays.
Hey this is actually Salveen dialing for Gena. Thank you so much for the question and congrats on the quarter. Maybe just to start, could you please share with us about the conversion rate of new derision for the launch product especially like Herceptin, Rituxan and [indiscernible]?
Let me ask Laurie to address that.
Yes, thanks for that question. As you know, we are limited to what we can say, but based on what our partners have said, but what I can say when I can point to is some recent comments from Roche that the Herceptin SC conversion outside the U.S. is about 60% and of course that is a number of years since the program launch.
Unfortunately they have a commented around the MabThera outside the U.S. conversion in a couple of years since 2016, but in 2016 they did trade that had converted about 34% to the market. So again, the most near-term a data point I have is that 60% Herceptin outside the U.S.
And then as for RITUXAN HYCELA Roche hasn’t provided any details but as I mentioned in the prepared remarks, we did provided an update of seeing more clinics begin at the conversion continuing in clinic. And they are supporting the launch now with some exciting direct to patient and activities as well.
Got it, thank you. Maybe just quick question on the financials. So, for the Phase I initiation of your partner program, should we continue to expect like roughly $5 million milestones?
Yes that is a great question, this is Laurie. All of our partner agreements are slightly different. And so while many have Phase I milestones not all of our study starts will have a Phase I milestone associated with it. Again, our most recent partners have a $160 million in milestones per target. But again, the amounts and timing of the target is different depending on the partner and the studies they are starting.
Got it. Thank you so much.
Thank you. Next question?
Our next question will come from Joel Beatty with Citi.
Hi and thanks for taking the questions. So first one is on the ENHANZE platform and the several undisclosed assets. Could you just add a high level explain a bit on the current Phase that they are ar. What is likelihood of those agents moving on to become name to late stage assets later on in their development?
Thanks Joel. It's certainly our pulmonary expectations that the majority of these product if not all will move forward and to fill development. We have most often seen that ENHANZE is able to very effectively change IV drug for subcutaneous. So it's my expectations that varying an unexpected technical difficulty once, we get the Phase I data which is generally down to health pick the dose. These products will all move into Phase III clinical testing and ultimately approval.
Great. And then one other question related to PEGPH20 and the combination with KEYTRUDA. I think I heard you mentioned earlier in the call that it seems like the response rate for non-small cell lung cancer seem to be higher than the response for gastric cancer. Do you have any hypothesis on why this might have been the case?
Yes. Let me ask Demetri to answer that question.
Sure thank you very much. You are right that the initial response rate in lung cancer that is the highest in gastric cancer. Now there might be a variety of reasons. One reason is certainly based on the inversion data we saw with other checkpoint inhibitors in the gastric cancer disease, that gastric cancer is not a very mood sensitive tumor type and that might be the most prominent explanation for [indiscernible].
Great. I got you. thank you.
Thanks Joel. Next question please?
Our next question comes from Jessica Fye with JPMorgan.
Hi, this is Daniel for Jessica. Thanks for taking our questions. For PEGPH20, could you provide us with an update on how you are thinking about developing and commercializing this asset?
Yes. Thank you [Daniel] (Ph). We as you know retained the global rights to PEGPH20. And as we are preparing for the upcoming data read, we have initiated planning for commercial launch in both the U.S. and see in European markets. Because that is prudent to do at the stage of your adds.
We certainly will continue to evaluate European environment to determine going alone versus a partner, but at this point in time, we are preparing and we will be fully ready to launch on our own in U.S. and top European markets.
Got It. Thanks. If I could follow-up. For the data for the KEYTRUDA combo besides response rate. What should we expect at the data presentation?
Yes Dan, I'm sorry you cut out a little bit, for the which data.
For the KEYTRUDA combo study?
Right. So as we mentioned during the prepared remarks, the study is still ongoing and so what we will be planning to do is continue to collect the data on the three ongoing patients in each cohort of this study, once we have that, we will submit this to a scientific meeting, which is likelihood for now in 2019 and of course that time we would report all of the data, including standard parameters like the response rate, PFS and [OSA] (Ph) in that single arm study.
But given the response rate today, I think really gives you a good color and pictures that we are seeing something intriguing in the PDL-1 negative patients with non-small cell lung cancer and we obviously didn't see the response that we were looking for in gastric cancer.
Okay. Thank you very much.
Alright. Next question?
Thank you. Next we have a question from Jason Butler with JMP securities.
Hi thanks for taking the question, its [Roy] (Ph) in for Jason. I had a similar question about the data ASMO for the - combo of breast cancer. I think - other than doubling the OR why you are excited about it. I kind of thought that program is on hold and if I could hear more about why you are excited about breast cancer and PEGPH20? Thanks.
Yes, we will begin that and see of Demetrius has anything to add. Why we are excited, is that this 36% response rate reported is double anything that [indiscernible] single agent have ever been able to see. So clearly that has been a very encouraging signal for us for what we might be reporting in progression-free survival and other parameters that ASMO.
Because this is going to be presented at a major scientific forum, because some of the analysis still ongoing. We are not in a position today to give any additional data, but we certainly speaking with them, our advisors people are certainly entirely encouraged by the response rate.
what we are doing is talking to our advisors about whether the path forward to further study PEGPH20 in breast cancer, see things that we always want to consider or what is the future competitive environment going to be like, what is the future standard of care and what is the size of the opportunity.
So while we are analyzing the data those discussions are ongoing, so that when we finished that assessment we will be in a position to talk about how we see future development in breast cancer. Demetrius anything to add to that.
No thank you [indiscernible].
Okay. Do you think will have a comprehensive update at the same time at ASMO or possibly after.
I think possibly after, when I think you will get the efficacy data that that is available at ASMO, but I do imagine just taking in context of wanting to make sure we are looking at all of the changes in the landscape we will be continuing to assess that certainly through the ASMO Congress.
Great. Thank you.
Thank you. [Operator instructions]. Our next question will come from Jim Birchenough, with Wells Fargo.
Yes, hi guys, congrats on all the progress. I guess a couple of questions from PEGPH20. Hi Helen can you hear me?
Yes, we can thanks.
Yes. Just on PEGPH20, and further investment in breast cancer and PD-1 combinations. And I guess overall broader investment. How will the 301 study results inform that investment? I guess what I'm looking for is, if it turns out that the Phase II data in pancreatic cancer weren't predict of a Phase III success. Does that set a much higher bar for advancing PEGPH20 in other cancers and I guess the opposite as well, if you have positive 301 results would that accelerate the investment in other cancers. Thanks.
Yeah, thanks, Jim. I think it's fair to say that we are taking a high bar based on the Phase III data for PEGPH 20 in pancreatic cancer. Now as we are waiting that data, what we are planning to do is to assess the opportunity and assess what the next steps would be to advance PEGPH20 in different tumors.
And I do anticipate that's going to take a number of months and coincidently I think the timing of all these decision is very likely to be sometime in the early 2019 in parallel when we get the pancreatic cancer data. So just by terms of our planning, we are going to likely to be making those decisions all around at the same time.
And then maybe just on the ENHANZE side. I might have missed that, but when you were talking about what is underlying your $1 billion 2027 royalty target. Does that include all eight programs going into the clinic this year or was there something carved out that was unexpected that would add to for that 2027 revenue projection.
Yes great question. Based on the three marketed products and seven all of the programs that are in development that we had line of sight to at the beginning of this year Jim. So on the call I announced the Bristol-Myer Squibb is actually moving not just one product into clinic this year but three.
These at last two products were unexpected at the start of the year. And so those were not in the original $1 billion projections. So its three marketed product and seven all the development products that make up the $1 billion. And I think it's nicely illustrated on Slide 3 where you can see at the bottom those are the two undisclosed target that weren't included in the original $1 billion forecast.
And can you remind us telling us if you look at all the collaboration ENHANZE programs. How many there are left to be identified and what the mix is between marketed products and development stage candidates?
So Jim to understanding your question. For some partners, how many have them targets that we haven't selected yet.
Okay. Yes I guess I'm trying to get a sense of what pipeline maybe feeding in subsequently 2019 and 2020 in terms of target. How many targets in aggregate are out there and if you think the cadence of programs we have seen this year can continue in subsequent years, based on the pipeline?
Alright. Just to I will use couple to illustrate it. Alexion is a good example basic four targets, they have only taking one of the targets in terms of what they disclosed. So certainly there is three additional targets. And Alexion is certainly very enthusiastic to continue to develop new sub cue formulation.
For Bristol that get 11 targets. You seen them move very quickly into the clinic with three targets and eighty other ones. I wouldn't be surprised that they continue to do that, because this is a part of their immunooncology strategy.
So just speaking of those companies with three plus eight that is 11 more. and within the other partners there are some other targets that are I know companies are thinking of potentially moving in. So multiple opportunities in our current partners, but don't forget we have got the potential for new agreements.
And so as we mentioned on the call, we continue an active dialogue with a number of partners and I do expect that we are going to see more partners sign up and move product into clinic as well. So I'm excited about this continued momentum that really began in 2017 and it's going to continue in 2019 with more products in and making progress through the clinic.
Great. Thanks for taking the questions.
Thank you.
Our next question will come from Eun Yang with Jefferies.
Thank you. And in terms of partnership update and you provided update on Roche, but it’s been on Alexion. How about other partners such as Pfizer AbbVie and [indiscernible] is there any updated to the provided.
Yes, I can say with Pfizer and with AbbVie we have no active programs in the clinic with them, but we continually in a very active dialogue as they consider any value at their portfolio to identify if there is any more products they want to move into the clinic. And Lily, as you know already have a product that is in Phase I, testing that is a study that started in 2017 and once again we continue in a very active dialogue, by potential and other targets as well.
How about Pfizer?
Pfizer I covered at the start the Pfizer don’t have any products actively in the clinic at the moment. We do continue in dialogue with them to identify if there is anything in their portfolio that would be suitable for taking IV to sub cue. So perhaps more to come in that at later date. For AbbVie and for Pfizer, there is nothing suitable today, but I believe there may be for the future.
Thank you. And then you mentioned U.S. patent issuance of PEGPH20, ABRAXANE [indiscernible]. Is that a method of the use pattern.
No, it was actually a composition of matter pattern, so obviously we are very excited to get this composition of matter patent, for use of PEG with ABRAXANE and gemcitabine with patent just out through 2033 with the potential that I will be further extended, its depending on certain events, so certainly this is very good news for the Company and very good news for PEGPH20.
Thank you very much.
Alright, thank you.
Thank you. And there are currently no further questions in the queue at this time.
All right. With that, I really thanks everybody for your attention and your questions. We look forward to seeing many of you at the upcoming conferences. Laurie is going to be at the Cannacord Genuity conference later this week and I will be at Wells Fargo and the Citi Conferences in September. Have a good evening everybody. Thank you.
Thank you, ladies and gentlemen. This concludes today’s teleconference, and you may now disconnect.