Q3 2019 Earnings Call
Greetings and welcome to the Phoenix Inc. third quarter 2019 earnings call.
At this time, all participants are in listen only mode.
A question and answer session will follow the formal presentation.
Anyone trying to acquire operator assistance during the conference. Please press star zero on your telephone keypad.
A reminder, this conference is being recorded I would now like turn the conference over to your host Mr. Kim Mccarthy with lifestyle Advisors. Please go ahead Sir.
Good morning, Thank you for joining our conference calls we provide an update on this business as well as a review financial results for the third quarter 2019.
The news release detailing the third quarter results crossed the wire earlier. This morning and is available on the company's website a.
A replay of this call will also be archived on the company website.
During the course of this conference call the company will make projections or forward looking statements regarding future events, including statements about financial and clinical milestones anticipated in fiscal year 2019 and beyond.
We encourage you to review the company's past and future filings with the FCC, which identify specific factors that may cause actual results or events.
For materially from those described in this world statement.
You can find our FCC filings in the Edgar database.
Got it in the Investor Relations section at our website at Phoenix Dot Com.
This morning, we are joined by Dr. Johnson Lowery, Chief Executive Officer, Mr., Jeff Gordon Chief Operating Officer, Dr., Rudolph Kwan, Chief Medical Officer, Mr. rentals East Chief Financial Officer, and several other executives who will be available to answer questions. After the prepared remarks.
I will turn the call Johnson for introductory comments.
Thank you, Tim Hello, and welcome.
Continued to be strong progress across the board, bringing us closer to becoming a 40 integrated global pharmaceutical company.
For the second time this year, we're pleased to be raising full year products sales guidance for 29 team.
We have several major catalyst upcoming equaling and oral presentation. All I could talk so it is like what are they too at the upcoming San Antonio breast cancer meeting and true anticipated Indeed fighting seen already 2020, which we expect to follow with record she is fighting either additional.
Global markets.
We also in the very strong position toolbar multiple potentially successful therapies in the future.
Well happy strategic including our operations and mentioned our resources to maximize the potential commercial opportunity drug candidates in development.
Yes, I bought a pipeline continue still bonds were looking beyond current indications and for ways to get the best labels and marketing outcomes for our products.
As we prepare to market our first <unk> oncology true up oral Paclitaxel and then secretary.
Well mix nothing significant progress to expand and optimize our commercial infrastructure.
We expect to be well compared to make significant impact with this product he literally once its approved.
Hey, So chief operating Officer Mr., Jeff Gordon will discuss you missed your pot <unk> ongoing commercial preparation you couldn't two weeks into profile of our new if Felix Encore did you break and become a recognize it commercial <unk> with differentiated products with pockets the cockpit tightens up.
Oh, Petrotec sold will become our flagship product to build our global brand upon approval.
Currently we are preparing to discuss the phase three data with the F.D.A.
Oh previously indicated that this study if successful could be adequate as a single comparative trial to support registration of oral paclitaxel and it's exactly the U.S. for metastatic breast cancer.
The positive data, we we bought in August was a major milestone for your Phoenix.
Adding to the strong body of clinical evidence that outcome free platform is working as design.
They significantly de risked the critical programs that follow including oral dose is excellent.
All you were told you can.
All told you can an oral you open it.
Based on the successful outcome of the phase three study.
Oral paclitaxel has demonstrated a very strong clinical profile from both efficacy and safety perspectives.
He said he met its primary endpoint.
So in statistically significant improvement in overall response rate compared to RMB paclitaxel.
They were also strong trends in progression free survival and overall survival oral paclitaxel compared to Ivy Petrotec. So it's well I said, we took a portion of confirmed responses on acrodex all with the Irish enough responsible breaks it down 150 days with this I, we packed attack.
So.
New Ropey was much less frequently with our effective tax off.
Which we believe is an important differentiating factor.
Importantly, this clinical outcome highlights the potential of our oral chemotherapy pipeline, what should we expect to the Buffalo Wrinkle attendances in combination approaches its taught a product cycle lifecycle management.
Our second M.D.A. east for our two manipulated ornament for treating and telecom ptosis for which we reported positive phase three topline results in March this year.
We've competed pre indeed consultation with the FDA.
The process of finalizing the submission will fade anticipates filing in the first quarter of 2020.
I'll upon ambarella is also preparing to submit the marketing authorization application in Europe .
We and our partner Ambrose I'm very excited to launch this product for patients with attend the CCAR process.
Who is seriously all effective therapy.
Under our agreement with Aberle, we're eligible for development and sales milestone payments and commercial royalties.
I also want to highlight our ongoing efforts to integrate our whole functions and capture value across the supply chain.
I'm very pleased that Phoenix has continued to expand our global capabilities and footprint.
Both in terms of clinical and manufacturing.
Well I'll part you products and for our customers around the world, which Jeff will discuss.
I will Neil and larger Apiay plants in China computer construction and he's anticipate two comments operation in first half of next year.
We're also expanding our global K. the code I wouldn't be capacity in Europe with establishment office subsidiary in the UK and we are growing number of trial sites in the region.
And we're delighted to report that the acquisition upside down assets in Latin America.
Close on October 31st.
These initiatives have been ticket with the goal of a dozen 18. This kept capacity to conduct clinical studies and support our regional marketing decision process.
Competition for patients globally has become fees.
Having that high quality Latin American kinda cooperation.
Allows us to draw from a population for clinical development, that's being overlooked by traditional big pharma mold.
Many of our new colleagues as side there would in fact during the by U.S. Big pharma companies. So they bring strong expertise.
Because of this enhanced global infrastructure.
We believe will be in the position to deliver substantial growth in mix among value over the years to come.
Only management front during the quarter, we announced appointment left up to 10, new land as president of excess Faro Physics limited to read the operations of our T cell immunotherapy platform.
Also as a senior director of corporate development flight Phoenix.
Dr. Lynn was previously the chip you listen to office Oh actually that's once.
He has over 25 years of medicine healthcare investment.
Well as leadership and Bces experience.
We're delighted to welcome him and look forward to his leadership and insect for this important and exciting exciting part of our business.
Finally, before I turn the call also I want to discuss the issue of several subset of reports from the same source that were published recently on our company.
This report contains an function and inaccurate information and as well as misleading conclusions.
We remain focused on execution and if you look at outright records. So far we've been making significant accomplishments, including successful delivery of two phase three programs.
And increasing our revenue guidance twice in 2019.
We take price integrity and loss experience of the entire they feed export a management team and importantly, we're committed to strong corporate governance.
At this point, we do not intend to comment further on this subject as we want to put I'll focus on what really matters, which is how pipeline value can it would be vitamins and business progress.
I'll now turn the call over to our Chief Medical Officer, Dr. <unk> plan to pull what an overview of our clinical programs.
Thank you Joe Johnson.
We have little thing I had confidently to us our first and the submission or a suffer a platform based on the strong data. We previously reported quality candidate oral paclitaxel.
And second data.
As a reminder, the randomized multicenter study in wall and two patients income pad our product so intravenous paclitaxel in patients with confirmed metastatic breast cancer and fall home Paclitaxel Monotherapies recommended.
We were very excited to announce that the study met its primary endpoints.
Showing statistically significant improvement overall, I mean, I could taxable income overall tumor response rate based on <unk> Ilalis's oral paclitaxel showed an overall response rate of 36% compared to 24% well Ivy Paclitaxel.
Agent.
And part of what is based on the received 1.1 criteria with a P value of Sito plus zero one.
There was also benefit in comes off the duration of response.
As we detailed on our last call. We also saw stall trends for both progression free survival and overall survival that faith, but oral paclitaxel.
We're also very pleased with the safety profile for all of that the text so.
In particular, we saw a much lower than they were up a fee compared to I view petrotec. So.
17% versus 57% overall.
And for break free neuropathy.
1% was 8%.
We're also see is the major dose limiting toxicity for <unk> actual treatment and can be chronic and irreversible.
Collectively the results of this pivotal study represent an important milestones in the development of this Neal class of oral anti cancer drugs.
Based on the phase three results.
We see compelling evidence in terms of the efficacy and safety of oral packet, Texas clinical benefit for patients with metastatic breast cancer.
We believe it will be competitive and has the potential to become a cornerstone in the treatment of metastatic breast cancer.
As we disclosed we a schedule that that if a an oral presentation of our phase three results at the San Antonio breast cancer Symposium on December 13th.
We plan to share additional inflammation arrived the topline efficacy and safety results that we report the in August .
We believe the physician community will find a beta compelling and look forward to this important updates.
In the meantime, that's currently working diligently to compete I'll end the submission for oral Petrotec, So which we currently expect in the first quarter next year.
We expect to provide an update after the end he has been filed.
Importantly, we believe this is only the beginning in terms of the where will we expect to demonstrate <unk> oral paclitaxel and I'll always discovery platform.
Well I was so high response rate and a strong safety profile oral paclitaxel.
I don't know reset the bulk cutaneous angiosarcoma and gastric cancer in combination with rubber Sarah Matt.
With respect to the Ed just sarcoma poke around potential to study has come met at least continuing to add real well I'll stop selling rapid and robust tumor response in part one.
We are planning to spend the study to the UK a lot of countries.
We were pleased to announce last week that we received orphan designation from the European Commission fall, Paclitaxel and and SEC, what all in the treatment of soft tissue sarcoma.
In terms of future opportunities while these product.
We are working to develop our opex tax so for additional indications and nice boring potential combinations with biologics.
Sample anti PD one.
And Tybee, Jeff therapies.
I will face one to study oral paclitaxel in combination with pad Brody Sublet Ocala, Florida.
That really well.
We also have advancing inexpensive phase of our global phase will be study of oral pack attack, so unless I clicked off with Red Mr., Matt in patients with at Las gastric cancer.
We recently pretty sad encouragingly cells from this study at the ESMO Congress 2019.
Looking to out all the phase three program cut the nibbling weideman fluctuating actually kind of ptosis.
We appreciate update that we have recently completed the M.D.A. consultation with the U.S.F.D. and are on track with the preparation of the and the submission.
Which is expected to be filed in the first quarter 2020 .
We continue to believe that covered lives. The billings came public safety profile and hi clearance race, that's upsets in the phase three studies.
First a competitive advantage over existing therapies like Kate.
We try to limit the buy side effects that negatively impact patient compliance.
So we look forward, bringing this variable treatment option to the market, Jeff will talk more about that.
Now turning briefly to our earliest stage kinda coupled reps.
This quarter, we allows that I'll partner sensei pharmaceutical initiate a phase one study of oral takes to free six one already know S takes all too.
Takes to 56 to one is being developed to treat real blastoma multi fabi all GBM.
You too is unique ability to cross the blood brain barrier.
Treatments are very limited floods GBM, so kicks to 46, what could become a potential the variable treatment option for patients will have high unmet need.
In summary, we are proud off the progress being made across our deep height lie.
We are continuing to execute what all the clinical programs.
We look forward to be something further updates in the field chip.
With that I'll turn the call to our Chief Financial Officer read those the.
Randall.
Thank you write off.
Sales for the three months and September 30, 2019 were 19.2 million compared with 13.3 million for the stream months and its Tempur 32018.
An increase over an increase of 45% year over year.
The increase was primarily attributable to an increase in specialty product revenue and fibrosis, we'd be revenue of 4.7 million and 2.5 minute respectively.
The licensing fees and consulting revenues for the stream month and at September 32018 were primarily in relation to the license agreement that we have entered into with <unk>.
Cost of sales for the three month ended September 32019 totaled 17.1 billion, an increase of 5.1 million or 43% as compared to 12 minutes. What is three months and September 32018.
This was primarily due to the increase of 4.9 million in cost of sales, resulting from the south of specialty products.
The increase in cost of sales was generally in line with Protestants increase.
Research and development expenses for the three months and the Septemberthirty 2019 were 19.6 million as compared to 51.2 million for the stream month ended September 32018.
The decrease in R&D expenses was primarily due to a decrease in licensing fees what technology. We acquired in July 2018, we booked a noncash license fee of 29.5 million and a three month ended September 32018, and it was related to the purchase of TC Archie technology.
In connection with the establishment of asset therapeutics.
Selling general and administrative expenses for the three months ended Septemberthirty 2019 totaled 16.3 million as compared to 11.5 million for the three months ended Septemberthirty 2018.
This was primarily due to an increase in cost of preparing to commercialize our proprietary trust and increase in general and administrative expenses, including legal fees and audit professional service fees.
Net loss attributable to ethnics for the three month ended September 30, 2019 was 34.8 million or 45 cents per diluted share compared to net loss of 46.2 million or 70 cents per diluted share in the same period last year.
We received a 20 million milestone payments from Emerald during the second quarter of 2019 in connection with the partnership entrepreneur doing and expect this payments to be recorded as revenue in the fourth quarter 2019.
At September 30, 2019, the company had cash cash equivalents restricted cash and short term investments of 129.2 million compared to 107.4 million at December 31st 2018.
Based on the current operating plan, we expect our cash cash equivalents and restricted cash as of September 32019, together with cash to be generated from our operating activities will enable us to fund our operations into the second quarter of 2020.
We provide revenue guidance for products that was only today, we're raising our products does guidance for the full year 2019 tend to increase of 35% to 40% year over year from 56.4 million in 2018.
This is versus prior guidance of 30% to 35% year over year and this is on top of the previous guidance increase we made in August .
This new revenue guidance has taken into account the discontinuation of our video precedence house and especially of operations at our Thai Hot Apiay plant. This revenue guidance excludes license and collaboration fees.
For more detailed discussion on our finance Joe's, including those specific factors that contributed to the changes a lot items on our income statement as well as financial results for the nine months and September 30 2019. Please.
Please refer to the Form 10-Q , two we filed with SEC.
I will now trying to call next to Jeff yard it.
Thank you.
As our regulatory and clinical changed work to prepare for NDS submissions for our two lead product candidate.
We have continued to expand and optimize our commercial infrastructure.
Develop the market in anticipation of commercial launch of oral paclitaxel.
We plan to be prepared to capture significant market share as efficiently as possible, establishing this product as the chemotherapy of choice for metastatic breast cancer.
As we've discussed Tim Cook, our senior VP of marketing has begun assembling his team of highly accomplished executives to lead our commercialization efforts.
We've now finalized our staffing and organizational plan.
And we'll begin to make additional key hires in early 2020, including medical science liaisons and regional sales leaders with the full sales channel.
Coming onboard in the months, leading up to potential approval.
We have also continue our discussions with experts in the areas access distribution and patient adherence to further understand the market dynamics for metastatic breast cancer that will drive our success upon potential approval.
We are conducting payer market research.
And happy to see a strong positive response to the unique product profile of our oral Paclitaxel candidate.
We're also working to refine the specific target physicians and patients segments. So we can have a focused promotion of the product launch.
We're expecting it should target physicians and patients who are early adopters of new therapy is supportive of an oral option.
Patients that are generally hands on in terms of working with our doctors to find the right treat for them.
As highlighted.
The next key event for us will be the San Antonio breast cancers symposium.
Well, we will have a substantial presence.
In addition to the presentation on the oral pack attached off and then secondly to our phase three results.
San Antonio will be an opportunity to continue the efforts introduced at ASKO earlier, this year and generate further awareness and interest in the Phoenix oncology brand.
Our activities around the meeting are designed to ensure strong presence and visibility with kao wells and provide concrete signals of our long term commitments Jordan colleges.
Specifically, we plan to watch our new campaign empowered the theme of which is empowering patients and why it's at the heart of everything another thing that styles.
As with ASKO, we'll have a booth staffed with medical affairs, and commercial personnel as well as initiatives, including a full page programming to drive attendees through our booth at our website.
We look forward to seeing some of you in San Antonio I would encourage you to visit our booth.
In parallel with our efforts around oral pack with that so that its Ecuador.
Preparing to submit the NDA for it to your banner drilling.
In the U.S. as Jonathan mentioned, we remain on track to file the NDA turbulent appointment is a novel treatment for access to care choices, which is terribly underserved market.
Upon approval armor, all will lead to commercialization efforts for the U.S. as well as Europe as announced by a small product launches in the U.S. and in Europe are expected in Q1, 2021, and Q2 2021, respectively.
The next retains the right for banner.
And significant global markets, such as Japan, Canada, Australia, Israel, and several Asian markets. We plan to access these markets in collaboration with regional partners or directly with our own resources, depending on the market conditions and the early commercial experience.
For Japan, everyone in the United States.
In addition to this late stage pipeline progress. We're once again pleased to report strong revenue growth for our existing commercial business.
Thanks Randall mentioned.
Our product revenue for Q3 meet our projections and this was driven by new and recently launched products, which were led by LIBOR Arthrex.
Apds currently markets 31 products with 59 skews.
Yes markets five products with 13 skews.
In the third quarter, we launch one new product.
With the goal of launching a total of three to five new products and the remainder of 2019.
After we discussed the litigation regarding days or pressure was not decided anything that's a spread.
While this was a disappointing result.
Certainly not unexpected and we have now discontinued the litigation proceedings and ceased marketing base or pressure.
They suppressant was a significant driver of revenue growth in 2018.
It has also been a contributor to 2019.
We will continue to seek opportunities to add to our portfolio of specialty pharmaceutical and fiber threed be products in order to drive further growth and leverage the brand recognition and relationships we have built in oncology.
On the manufacturing from work continues on building, our New York State funded production plant in Dunkirk, New York, which we continue to anticipate becoming operational in the second half of 2021.
Once it is online we will begin with cgmp commercial manufacturing of our injectable and five or three be products and eventually our proprietary oncology products as well.
Exterior construction of the 409000 square foot plant is complete and we are well underway with the interior construction with the expectation that will order the filling equipment late this year.
Our early next year.
We look forward to completing construction and bringing this facility online.
X U.S., we announced in September .
We completed construction of our new 440000 square foot Apiay facility and chunking churn it significantly expanding our apiay production capacity to support our global clinical development needs and ensure an uninterrupted supply.
To support our future commercial launches.
The opening of this facility is part of it the mix is ongoing strategy for vertical integration in order to capture value across the entire supply chain.
The facility will be producing validation batches and we expect to commence operations in the first half of 2020.
As you may recall in the second quarter of 2019.
We decided to suspend operations at our current manufacturing facility in China.
After a few incidents occurred at unrelated facilities in the region.
However, we believe we will be able to support the requirements for Phoenix is ongoing near term clinical studies and registration activities for late stage clinical products.
And we have taken steps to secure additional backup sources, we will provide an update in due course.
So to summarize we continue to execute successfully across all of our strategic objectives with respect to our commercial preparedness vertical integration.
We're continuing to leverage abroad opportunities establish our global oncology brand and build out our marketing infrastructure.
We're actively developing the market and honing our sales strategy in advance of the anticipated product launch for oral paclitaxel and separate our.
Based on the positive feedback and progress we've made to date, we expect to hit the ground running as soon as the first product is approved.
I'll now turn the call back to Johnson low Fourq is reasonable.
Thank you.
We remain on track to 2019th transformational year for eating that which we believe we're positioned the company that's a global leader in oncology.
And as we advance to whats to end the findings in the coming buttons were looking to plenty plenty to be another you called <unk> growth.
<unk>.
For the exciting opportunities ahead of us in terms of commercialization as well as <unk> expanded capacity to conduct global clinical trials there with.
Our development pipeline forward.
Adding substantial value for our stake holders.
We look forward to sharing our children with you as we continue to execute our long term growth strategy.
We would now you happy to take your questions.
Thank you.
Thank you at this time will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation code will indicate your line is in the question Q you May press star to if you'd like to remove your question from the Q.
Participant using speaker equipment and may be necessary to pick up your handset before pressing the star Keith one moment, please while we poll for questions.
Your first question comes from the line.
Lee.
Wang with JP Morgan.
Please proceed with your question.
Thank you for taking my questions and congratulations on the problem.
First question is out.
Okay.
Our <unk>.
Why you might be meeting with DAC, D.A.O. <unk> Dot Oh rock, so filing and secondly, with regard to the San Antonio.
<unk>.
I think you measure you will detail on August data.
I was wondering what are there any chance for brought us to see I'm more update on data, especially with regard to.
Sorry.
Oh.
And then maybe lastly can you comment.
You mentioned that potential Oh violence in other regions, maybe you can help us to understand exactly.
<unk> strategy there.
To to look for partners to to exploit warranty deferred your opportunities out there. Thank you.
Ah So Rudolph here, let me answer to your three questions.
The first one is regarding the updates on the process with the FDA on a on Rx So and I can tell you. We are actively engaging with the FDA on oral paclitaxel and we are on track with our preparations well and the submission first quarter 2020 .
Your second question is what they need to.
Regarding the phase three trial would you expect to see in San Antonio.
And we definitely intend to please send a full of dataset from the top line phase three results announced in August .
Some examples of those full dataset.
What include the Standex like demography subgroup analysis details safety profile et cetera. We believe we have very compelling dataset to please send to the precision community as well as to all view.
We are planning to.
Although you have an asset that you are the losing too we are looking at further data on.
Oh, Yes, Oh PFS as we.
The visit eat into I will reinforce.
What we have set all our law that we're planning to see guidance from the FDA before defining Neil PFS and unless they took cutting off so we cannot comment on when this will be ready for presentation that thing and Tony or not at this time point.
I'll objectives is to ensure that the best outcome from a regulatory and commercialization perspective.
Got it so.
Last question is regarding reckitt atri outside the U.S. right.
Yeah, you add if a planning and.
Discussion regarding.
Other territories of course, you used the most important one China, Taiwan and new student all record each authorities, we are targeted to discuss with.
Okay, great and in those regions.
Do you do you plan to look for partners.
Oh.
We are exploring opportunities certainly the advantage and pros in terms of Haven partners in the same time, we want to make sure that we will be equal to capture the maximum opportunity I'll return for our stake holders, we do have a lot of experience.
This weakness as well and based on the loss experience that I'll management team, but we have and therefore, we do have different options to explore piece that territories.
Okay. That's helpful.
How much.
Thank you.
Your next question comes from a line of Kennen Mackay with RBC capital markets. Please proceed with your question.
Hi, Thank you for taking the question now that were three months to today actually after your positive or I felt the free topline data announcement.
Can you help us understand what what the regulatory interactions happen. So far I really do imagine that at this point you've reached out.
To be up for a meeting, but do you have to house I think 30 days or maybe further to respond in a further window.
First joined can you just help us understand if an image initial meeting has taken place that are worth one has been scheduled I ask because to Rudolphs point it sounds like the potential to see minded PFS and OS data at San Antonio might be dependent on after your feedback evaluating some of these secondary endpoints and.
Ways of doing this in a good statistically rigorous manner.
Moving forward in a minute a second question on.
The regulatory pathway I, just wanted to confirm or after the initial endorsement of the initial trial design.
Being sufficient for regulatory approval was based strictly on the primary endpoint of our our I'm not dependent on a PFS or more or less during these were secondary from then I had a quick follow up on our strategic options as well.
Thank you Ken.
The we're actually indicate we are actively engaging the F.D.A. in communications in discussion regarding the Rx so.
Submission and we're on track to file first quarter I think I'll leave it at that point I'll also PON used to the fact that we don't normally.
Communique F.D. communications as you may have notice for our Cup Ilim billing program, we complete our P.M.D.A. consultation that we did not.
Except those just one of the process, we could crying in achieving the submission pocket. Okay. So we'll announce our submission that definitely we'll do that.
The file data regarding the if thing Antonio again, it will depend on the peak that we shall we see from the FDA regarding the endpoint and to put it again on the rack caught our previous dialogue with the F.D. consultation.
Can you just based on the pie Marie and point of response rate DPF as an asset.
Secondary end points and they do not but they're not a requirement for the F.D. consideration does that answer your question.
Yep, Okay very helpful.
Thank you.
Very much for that or maybe just a follow up then on strategic options here and potential for maybe bring non dilutive capital young walk going on with several regulatory submissions approaching can you maybe just remind us the geographies, where you retained ownership of Petro one I think oceana was one of these were.
Cemetery <unk>.
The most prevalent and one of the largest markets or and if.
If this could be a a potential option for it's my something here could be a potential option for bringing in some non dilutive.
Capital or are there or any other options out there that maybe we should be thinking about thanks again for doing the question for looking forward to San Antonio.
The cakes. So one all tepid never been a compound was six your discovered and developed by the Phoenix. So we only global right our partnership with Amro. They have acquired the rights to a license that rice, who Europe to U.S.
Not even excluding Canada, and <unk> and Mexico, and also with Russia. So we own the already are the global test rates up happens. This three areas no all in all to see your question with regard to the way that they ought to opportunities in terms all known died of <unk>.
So with ought to geographic regions. What this compound what I will like to say is that we wouldn't like to explore opportunities set up beneficial and creating value for south stick hold us now certainly we'd have to be successful phase three resells assets and therefore, you can contemplate.
They have quite a number of orbitz decent option, if he's lying in front of us and our job is to ensure that we captured the value so to the you'll be inappropriate for us to Hawaii details allow this were evaluating these opportunities and discussion so it could be ongoing and thank you for your question.
Your next question comes from the line, Kevin Degeeter with Oppenheimer. Please proceed with your question.
Thanks for taking my questions, maybe maybe Q for me first off can you just comment on preparation for CMC for the oral paclitaxel.
Andy a submission in the first quarter 2020, specifically you know any outstanding steps that will need to be completed two.
Oh filed that portion of the submission.
Oh I forgot to your first question, we're actively preparing for the submission of the CMC sections.
As indicated to you that we've contemplated that to be a very important product with a substantial market potential so on top of resolving all the logistics and the Apiay and then deep the product manufacturing. We're also looking into playing in plain C.. We said, we we have.
Both the primary supplier base how cells. We also have club pickup is an ultra of supply is to ensure that when we are able to launch a product that will be no interruptions. All these activities are it could be ongoing and delta I missed the Jeff Yodle and myself are actively engaging to ensure that.
All these a smooth <unk> process, a smooth and there will be no interruptions Chaucer says I hope that decides to your first question.
Sure and my second question actually pertains to comments at me Jeff made in his prepared remarks with regard to a new show outreach and been payer research and if perhaps you can elaborate a bit more in terms of aspects of the oral paclitaxel product profile.
Resonated strongly with.
With some of them some of the payers in that initial outreach.
Jeff Yeah.
Yeah this would be.
Happy to do that.
The feedback we've had and about three different forms that we felt was that there were very encouraged that our pricing targets or look to be acceptable Oh, we are pricing similar to the original abraxane pricing.
And the feedback has been very positive so we're encouraged that.
Based on our forecasting based on the selling price we look like we're in very good chip.
Great. That's very helpful I'll get back into queue. Thank you.
Okay. Thank you. Thank you.
As a reminder, if you'd like to ask a question. Please press star one on your telephone keypad.
As a reminder, if you like to ask a question. Please press star one on your telephone keypad one moment. Please while we poll for more questions.
Your next question comes from line of Chad Messer with Needham and company. Please proceed with your question.
Great. Thanks for taking my question and let me add my congratulations on all the progress and I also I'm certainly very excited for for San Antonio.
Maybe just one for Rudolph to start I'm kind of looking forward.
What is your sense of the.
The regulatory Tory strategy for getting you know forgetting Iraq Sol and are there other indications you've got some interesting additional studies run a you're calling all in phase one or two kind of wondering if you think any of those might support label expansions and all.
Also do you think you'd have to do this piecemeal in each individual indication or is there. Some level of evidence you could provide that or acts all is basically a better paclitaxel and could be used anywhere it's used.
[noise]. Thank you Chad.
Youre quite right already so it's space on a no more to kill a private tech so which has been study intensively and that's why the use multiple type of cancer types and multiple.
Scenarios, so see the deep possibility in the sense is like and see if you look at that number publications on Ivy Petrotec. So it's puppy well over 1006 7000 so.
Our strategy S. I always ethically is to laugh rates that rather than repeating that and I think incomes all showing the.
Comparison with Ivy Petrotec, so we choose the monotherapy as a comparison and you will be seeing the compiling data from San Antonio, but you'll see the full dataset and I think we clearly differentiate that from Ivy petrotec, so with the strong.
No one else have certainly so filed with the tech seen offset lower neuropathy in the platts and have a better efficacy. So this is a very very compelling piece of data that we will laugh grage expand into other indications. The first all this one is tool and hand the.
Yeah.
The MH off the efficacy of Paclitaxel, and especially already so in wherever it if it goes treat cancer types like angiosarcoma Coziness Endos Arkoma and you are seeing that we have been reporting.
Very rapid poke grass Eaton and Roman in a very very ready cease and desist because all the.
Hi, Murray investigators the principal investigators and process some of the data so I'll leave it that you've seen some early data should expect to see continuing excitement for the indication. We also got the you.
Approval for often junk indication for soft tissue sarcoma, which includes angiosarcoma and therefore, everyone is excited about that so stay tuned you'll see some of those data coming in the field show in terms of other indications we have already alluded to we had combination immunotherapy.
And anti Viekira, we Jeff.
Products and those will be announced as that they'd have become more mature. So certainly we are expanding into whole other indications and we'll lap or age whatever has been useful type attack, so and built a further back to that the original Ivy Paclitaxel.
Oh in terms of record heat treat again, we are focusing on the U.S. and then we'll continue to do.
Oh the in indications that also other areas up building on metastatic breast cancer and left raging angiosarcoma and other indications as they become mature.
[noise] great. Thank thank you for thank you for that and then maybe one for for Jeff you talked about some of the market research you're doing in preparation for the launch in that you.
I think you'll be initially targeting early adopter physicians in sort of hands on types of patients can you talk a little bit more about that does this you know does this mean, we're gonna be targeting sort of the larger centers of excellence.
And maybe trying to get some information out to the consumers you know internet or adds or how do you. How do you go about getting that that segment of sort of early adopter proactive a.
Patients and doctors [noise].
Sure Yeah, and it's interesting.
Things are getting so sophisticated now that we have access to <unk> incredible data that gives us profiles of these things [laughter] and really that's the best way to lift when it is we're going after physicians that we know will be most responsive to this type of therapy.
And as we make progress with those physicians will trickle down to others are so we have a very specific.
Super positions that we've already targeted identified and our first marketing programs will be.
To to those positions and then we moved to a second set and then eventually books are itself.
I hope that answers your question.
Yeah, Thanks, and congrats again guys [noise].
Thank you [laughter].
Your next question comes from the line of Yale Jen with Laidlaw <unk> Company. Please proceed with your question.
Good morning, and thanks.
Taking the questions.
The first question I have is that.
Some of that says.
So what are the or tax so if you compare with let's say the weekly.
Regimen or do you see any benefit outdoor attack, so, particularly in the safety side or two that.
<unk>.
Yes, clearly the did the major benefits they don't have to come fall weekly fields and they get trip to the infusion center, but since you asking about safety and definitely you will you will you.
You will see that.
We have announced already that he say significantly benefit in neuropathy.
And if you look at that literature Catelotti.
Tom neuropathy dose limiting the relative we're talking about great free Grateful and Oh, you look at it did the chip everywhere you see is.
Dose limiting toxicity fall all highly petrotec, so all Ivy Paclitaxel dosing regimen and expect should be in a weekly infusion.
I think we have a major significant advantage in that back to differentiate our sales from weekly IB.
Hi Tech so.
So do come to us Antonio you'll see the whole dataset.
Okay, Great. That's very helpful. Maybe one follow up here, which is that you might be a little bit too early.
About the pay or.
Research so.
Hello.
Might be provide.
They also.
Oh publicized they should process.
Hi, Jeff Yes.
Yeah.
A couple of things one than the original plan.
Was to be looking at pricing equivalent to Brexit person.
And also get to a very good idea about the argument that you know do the generic tax all cost as much.
Would would payers be willing to pay and because of the a the examine juicy inherent advantages of our product.
Very encouraged to say that yeah the.
The abraxane pricing seems to be one that's going to be widely accepted by most payers. So.
It's early but we're very encouraged by that by that down.
Okay great.
Maybe just talk a lot more questions.
You mentioned that you are seeking the F.D.A. guidance in terms of cut off time for the progression free as well so as overall survival.
Just curious.
What do you think you might get any feedback from the agency prior to the San Antonio meeting or that's again difficult to tell it does that at this moment.
Yes.
We.
As I said, we cannot dictate when the F.D. will answer that specific secondary endpoint in question.
The specific platinum we.
I want to get clarify is about seasons is not pay specifying a protocol is a surprise pleasant surprise upside as a secondary endpoint that we're seeing a strong trend.
What would be upset the bulk.
To put it in the final analysis.
Now to put it into that analysis plan. So we want to that more clarity from the FDA before we actually implement that because that.
We'll be very important we'll all regulatory strategy and the labeling perspective.
I need to that.
Okay, Great. That's very very helpful again, congrats and I look forward to see the nics data updates.
Yeah, I just want to give you an update in terms of for your second question you often see can anticipate that we will be conducting a thought pharmaco economic studies with regard to the value of our product.
In terms of the value that we are pointing to both patients as was the pay us and all this office seat I will very much support the proposition that with proposing to both the ER the patients as well as such they pay us. So I think all this important considerations that you may want to have in your mind.
With regard to how with an approach launching that product and certainly with boss experience in launching products. We sell team in terms of both clinical development post approval support as well as some marketing and sales I think that so how did you you would pick up to the fact that we're well prepared to launch this.
Product successfully thank you.
Okay, great and that's it again.
Appreciate that.
Thank you.
Ladies and gentlemen, we have reached the end of the question and answer session and I would like to turn the call back to Dr., John somewhere else CEO for closing remarks.
Thank you everyone for your time. This morning, we have mixed significant progress and continuing to advance to us major catalyst.
For those quite interested in our oral predicating EXL and second of data would like to so strongly encourage you to join us in the upcoming San Antonio breast cancer.
Symposium the presentation will be the often noon on December 13th and would have.
A good presence as well as say inviting you to join our booth for those school not able to attend our de meeting will be able to pull why did you update after the meeting and therefore when should that off you update with regard to the progress and also the preparation work that were prepared to launch this very important product.
Thank you again for your time.
[laughter].
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
[noise].
Oh.
[noise].