Q4 2020 Athenex Inc Earnings Call
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[music].
Greetings and welcome to the Phoenix, Inc, fourth quarter and fiscal year 2020 earnings call. At this time, all participants are in a listen only mode of <unk>.
Question and answer session will follow the formal presentation, if anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder of this conference is being recorded.
I would now like to turn the conference over to your host Mr. Steve Rubis Senior director of Investor Relations for of Phoenix. Thank you you may begin.
Good morning, and thank you for joining our conference call the.
This morning, we published two press releases the first announces that we received a complete response letter from the FDA for oral Paclitaxel, the second announced as our fourth quarter and full year 2020 financial results. These news releases crossed the wire earlier. This morning and are available on our website.
Today, we will provide an update on the Phoenix its business as well as a review of financial results for the fourth quarter and full year 2020.
A replay of this call will also be archived on the company website.
During the conference call the company will make projections or forward looking statements regarding future events, including statements about financial business and clinical milestones anticipated in fiscal year, 'twenty 'twenty, one and beyond.
We encourage you to review the company's past and future filings with the SEC, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward looking statements you can find our SEC filings in the Edgar database at Www Dot S E C Dot Gov.
Or in the Investor Relations section at our website at Www Dot Athene ex Dot com.
This morning, we are joined by Dr. Johnson Lau, Chief Executive Officer, Mr. Jeff Gordon Chief Operating Officer, Dr. Rudolf Kwan, Chief Medical Officer, and Mr. Randall The Chief Financial Officer, who all will be available to answer questions. After the prepared remarks, I will now turn the call over to Johnson for introductory.
Doctor He comments.
Thank you Steve.
I will provide an update regarding the complete response letter really simple oral paclitaxel.
And our first FDA approved product cause theory, and the launch of people attended the call over the.
Two our chief Medical Officer, Doctor, who the quad.
This morning, we announced the debt the FDA issued a complete response letter related to the new drug application for oral paclitaxel.
We are surprised.
The appointed with the Fda's decision.
We believe that oral paclitaxel demonstrated a superior efficacy and safety profile in the well controlled at the phase III trial setting.
And we remain committed to exploring all options to unlock value from these assets.
I will give a quick recap of the issues raised in the complete response letter.
Dr. Kwan will provide additional details later in the call.
The FDA expressed concerns about safety risks associated with the increase in mutual PBA related cycladic.
The agency also express the uncertainty with regard to the primary endpoint assessment conducted by the blinded independent Central review in the Phase III trial.
The ft recommence, we submit the results from our new clinical trial and does the one we elaborate on all of these later.
The team is actively working to NN life and respond to the complete response letter.
We will request a meeting with the FDA to discuss his concerns as soon as possible.
During the meeting we hope to align with the F. D. All of the path forward required to obtain the approval.
The complete response letter represents a disappointing outcome.
The only for us.
But also for our colleagues conditions.
Patients who held the line.
For the pace development of oral paclitaxel in metastatic breast cancer the taser.
As the company, we're working to identify the.
The appropriate internal bulk of our seasonal adjustments accordingly.
We will be able to communicate more out these adjustments once we gain clarity on the path forward for oral paclitaxel from the F D. A.
Despite the disappointing outcome with oral Paclitaxel our team achieved the regulatory success with the FDA approval for cash series late last year.
Let me provide you with an update.
The product has to be the approval for the treatment of actinic keratosis of the phase.
Phase of Scott It has already been launched in the United States with our partner Emerald.
The launch of <unk> in the United States per wife's decisions with a compelling new product that can benefit patients.
Considering the is the novel topical first in class microtubule inhibitor indicated for the topical treatment of actinic keratosis, Okay face all stop.
In two phase III clinical trials, the theory demonstrate the efficacy and a favorable side effect profile.
The shock treatment protocol is unique S. Kasumi requires one state of the application for all the five days.
The demonstrate the efficacy and safety profile positions cause CRE as a compelling new treatment option for patients with actinic keratosis. The second most common condition the dermatologist in the United States.
In mid February the New England Journal Medicine, published the results of our true phase III trials debt.
<unk> is the foundation for the approval of Kousseri.
The publication of these data reinforce the innovation and clinical significance of the theory and further raise the profile and awareness of the theory of possible treatment option for physicians.
In terms of launch Ambarella intends to reinforce its U S sales force to surpass the support the marketing sales force effort.
The marketing authorization application is also currently Adobe view by the European Medicines Agency.
<unk> maintained attractive economics around the company's partnership with MRO.
In addition to the $15 million upfront and additional milestone payments already received and.
The Phoenix is eligible to receive up to an additional $65 million in aggregate milestone payments associated with the the series launch and expansion into additional indications.
Additionally, the company is eligible to receive additional sales of milestone payments and is eligible to receive tiered it.
Royalty payments, starting at 15% of annual net sales.
In conclusion, we had record success for consideration.
For oral Paclitaxel I want to reiterate our belief in the superior efficacy and safety profile of oral paclitaxel.
Phoenix, we mix focused on unlocking mix some of them value around not only oral paclitaxel, but also deepwater all stuffy program.
We are committed to breast cancer patients.
Our focus on bringing the these asian to the market.
Rudolf.
Thank you Jonathan.
This morning.
We announced that the FDA issued a complete response letter for oral Paclitaxel.
The complete response letter stated that the agency cannot approve the application in its place in the fall.
We ask the price and extremely disappointed with this outcome.
And the licensing the details of this complete response letter.
The agency expressed two main concepts.
The first cancer.
We walk around safety risks associated with an increase in neutropenia related <unk>.
At this level of foundation that neutropenia without the stance of no pharmacological effect of Paclitaxel.
Especially in patients with hepatic impairment.
In the Paclitaxel label.
We believe the FDA is particularly concerned on the early my low toxicity related debt.
Despite the overall survival benefit trend that we reported in the study.
The second concern expressed by the FDA.
We work.
In the southern tier Holford. The result of the primary end point of objective response rate or <unk>.
At week 19.
Conducted by blinded independent Central review.
The ICL.
The agency stated debt the ICL reconciliation and we reprocess Mei.
It may have ensured deals of meshed bias and interest on the <unk> ICL.
Our phase III trial use the industry recognized those standard of the ICL.
Which is a completely independent and totally blind the process for the primary endpoint of OS.
All of procedures.
The specified and followed.
The FDA all of the that the process looking at the index at the sponsor the Kerr.
The trial site and in making the lap conducting the ICL and we were informed that no fault for 83 split issue.
We hope to gain clarity on the TICC Alcon says when we meet with the FDA.
Lastly.
The agency request that we submit the south from the Neil adequate and well conduct the clinical trial.
For the patient population with metastatic breast cancer representative of the population in the United States.
The agency for the state that additional risk mitigation strategies to improve toxicity.
Which may in what dose optimization and or exclusion of patients deemed it to be at high risk of toxicity are required to support potential approval of the NDA.
Throughout the reveal process, we engaged in the robust dialogue with the FDA regarding our package.
As with any FDA review the agency May information requests.
And raise questions during the process.
We provide that a significant amount of information and clinical data that you asked the agency's questions.
During one of these 14 exchanges the.
The company, even suggest that the limiting the population of patients in the label the.
With our hepatic impairment and with potentially avoid access early mortality filter of Milo toxicity the.
The agency did not accept this proposal.
We will request the meeting as soon as possible to discuss the complete response letter.
And to align with the FDA on the pathway forward to obtain approval.
We continue Paul addiction in the superior efficacy and safety profile associated with oral paclitaxel as demonstrated in our phase III trial.
The higher response rate.
Lower neuropathy and strong trend in both of our survival couple.
Coupled with oral delivery.
<unk> oral paclitaxel could be of meaningful treatment alternative for breast cancer patients.
We are committed to creating maximum variable around the only oral paclitaxel, but also our entire are of discovery program.
I will now turn the call over to Jeff.
Thank you Rudolf.
I will provide an update on current developments with our infrastructure and supply chain.
And the existing commercial business.
The supply chain for our Tilda Earth's free lunch.
Is in excellent shape.
The Phoenix is responsible for the manufacturing of <unk>.
For clarity.
Our clearance from New York facility ship launch quantities to armor all true.
Two weeks ahead of schedule and position the amaral for a successful launch.
Further more we are able to supply as much inventory as needed.
We will far exceed the current core cash.
The performance of our client's facility underscores the high efficiency.
Of our integrated business model.
We have recently received approval from the Chinese government to begin manufacturing at our new larger API facility in Chongqing.
The new API facility will allow us to manufacture of portfolio of raw materials, and we expect to generate revenues from these products in 2021.
Construction of our facility in Dunkirk, New York is nearly complete.
The facility will serve the commercial needs of our specialty pharmaceutical business.
<unk>.
Use of our proprietary products.
Beginning in the second half of this year.
We plan to dedicate a portion of the facility.
The manufacturing by both III V products.
The increased manufacturing capacity.
Allow us to more than double our capacity for these segments of the business.
Currently we sell every unit we can manufacture.
And clearly our goal is to substantially increase our capacity to increase our revenue.
Yeah.
Our specialty pharma business performed well in 2020.
As a result, we recorded a $105 3 million and product sales.
31% year over year.
The COVID-19 pandemic drove both positive.
And negative effects and performance last year.
Yeah.
While the elective surgeries are down significantly the.
Demand for specific drugs used to treat COVID-19 hospitalized patients increased.
The biggest contributors to the sales growth in 2020.
Included products, such as the ex one time again.
The zip for myosin.
Pursuant sales went back to them.
<unk> got for Roxanne.
Our Phoenix Pharmaceutical Division currently markets 30 for products.
With 63 Skus.
<unk> pharma solutions markets six products and <unk>.
19 Skus.
We have just recently launched the room temperature stable cyclophosphamide.
And we will continue the launch new products in 2021.
We have identified over 60 products that we can potentially add to our portfolio.
Many of which are high margin products.
I will now turn the call over to Randall to discuss our financials in more detail.
Thank you Chad.
I will highlight a few key financial items in fourth quarter and for the full year 2020.
More details please refer to the earnings press release published earlier this morning.
Revenues from product sales in the fourth quarter for $21 8 million.
The 54% year over year increase for the full year 2020 product sales were $105 3 million.
31% increase year over year for the sales growth is attributed both to the significant increase in specialty product sales driven by increased demand for COVID-19 related drugs and the launch of additional products.
Part of sales growth was partially offset by decreases in API and <unk> product.
On the expense side SG&A expenses have gone up year over year.
Increases in SG&A expenses were primarily due to increase in commercial preparation costs associated with the possible approval of oral Paclitaxel and work force expansion at our manufacturing plants.
In addition in the fourth quarter of 2020.
Recorded a provision for potential credit loss of $8 9 million.
Yes.
Which included an outstanding balance due from Shaanxi and associated expenses related to currency conversion.
The provision is related to the 10 million of license revenue, we recognized in the third quarter of 2020 in connection with our partnership with <unk>.
Net loss attributable to of Phoenix for the fourth quarter and full year 2020 were $49 5 million and $146 2 million respectively.
50, <unk> III.
And $1 72 per diluted share respectively.
Excluding the credit loss provision of $8 9 million net loss attributable to Athene ex for the quarter was $40 6 million of 43 cents per diluted share.
Excluding the onetime debt extinguishment expenses of $10 3 million and $8 9 million credit loss provision net loss attributable to Phoenix for the full year 2020 was 127 million or $1 $40 49.
Per diluted share.
As of December 31, 2020 Athena.
The Phoenix had cash cash equivalents and restricted cash of 86 1 million and shops from investments of $138 6 million.
In terms of product sales guidance.
We're limiting financial guidance, the only the existing part of portfolio, which accrues excludes any proprietary products into meaningful sales data from CRE.
On the available.
In 2020, we recorded a significant amount of such revenues for international customers and the result of the global pandemic.
However, we do not see these revenues as recurring in nature.
While we have been continuing to expand our product portfolio.
We currently expect our product sales in 2021 ex.
Creating any thoughts from the <unk> to be in line with what we have achieved from 2020.
I would like to reiterate our cash runway guidance provided in November based on our current operating plan, we expect our cash cash equivalents restricted cash and short term investments as of December 31, 2020, we've got us into the second quarter of 2022.
We believe with additional cash preservation measures.
Our cash the only will get further extended.
Please note that our estimate of based on conditions, there are known and reasonably novo to us and subject to change the two changes.
In the street and macroeconomic conditions.
I will now turn the call back to Jonathan.
Thank you Randall.
We will now open the call for questions.
Thank you at this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.
The confirmation tone will indicate your line is in the question queue.
You mean from start to if you'd like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up of your handset before pressing the star keys.
Our first question comes from the line of Omar <unk> with Evercore ISI. Please proceed with your question.
Hi, Thanks, so much for taking our questions Johnson as I think about the issues you guys have talked about from the complete response letter it almost feels like either there could've been exclusionary language for hepatic impairment or on the response rate side, presumably O F has no bias irrespective of what.
The metrics are used and it was at least non inferior if not trending in favor of so I guess my question is.
And we've seen United Therapeutics try this why can't you resubmit without any new data.
But this time with a lot more resources thrown at it number one, especially again in the context of Covid and some of the.
Challenges with travel for patients and secondly, if you were to perhaps in parallel start a trial either single arm or like a keynote 21 G.
100 patients out of 20 patients could you have interim data by first half 'twenty two.
And finally, Johnson finally, if I may I'm.
Curious if you guys or FDA did that stringent assessment of response rates and what that look like thank you.
Thank you.
Do you I wanted to ask the pinnacle.
Questions.
Thank you for the question you.
You have quite a number of component on that so please.
Uh huh.
The piece some of those <unk>.
I did not answer all of those okay. So the.
Question regarding the excluding.
Patients.
With the hepatic impairment, we already make debt proposal to the FDA and the update did not upset that proposal.
Regarding overall survival as you'll know we update the overall sort of LIFO based on the wrong, 65% response.
The response rate.
On the on the.
Please send the anything until Aneel in December we continue to follow up those patients. So that is a good point debt, we will raise with the FDA at the upcoming planned.
Planned the request for meeting at where the debt.
And the merit in providing it for the update when the data becomes the more mature.
So can.
Can you remind me what other questions I may have missed.
Okay.
I was also just curious.
If you could run the trial like keynote <unk>, one G and have interim data by first half 'twenty, two which could be used towards filing and or why can't you just resubmit without new data and more resources that were out of it.
Yeah, I think the the first question will depend on what the FDA will.
At the stretch.
We will require in their complete response letter they clearly want a study so that is the subject for discussion and we will elaborate on debt. Once we got clarity following the meeting we certainly will want to.
Go in the King of <unk>.
So your proposal is not an unreasonable one we'll take that into consideration.
Regarding lease operating without new date without additional new data certainly pieces of land Neil will discuss the live meeting as well.
I would concede the perhaps.
Reinforcing the overall survival analysis as we as I mentioned earlier on profit than be submitting with our new data that may be more convincing argument just in my view that's the answer your question.
Thank you very much.
Just to.
The further for you on the win when we were having discussions with key opinion leaders.
Some of them actually were highlighting that the overall survival debt.
Clinical studies will be more effective.
<unk> will be looked at many.
Arthur Interventional therapies up to be applied to the patients.
In our industry.
In the geographic areas that we took all of our clinical studies and the comment at the time was that our overall survival analysis should be both clean compared to a lot of the studies.
Our geographic area of Sip the a lot more.
For the offline fifth line therapy are being tested in terms of Covid.
Creating confusion with regard to the analysis. So we felt that that was a very important point and certainly don't include Otis opinions in our response and send it to the U S F.
U S FDA during our meeting.
Thank you.
Thank you Omar.
Okay.
Our next question comes from the line of Jonathan Chang with SBB Leerink. Please proceed with your question.
Hey, guys. Thanks for taking my questions. First question can you provide more color around of the regulatory comments, suggesting a new study in patients representatives of the U S population.
Assistant create SCS, Jay taking issue with and what implications does this have been of potential future study.
I guess, what geographic locations. Besides the Alaska this comprise of.
Yeah.
Yes. Thank you for the question the reference to the U S population is very.
Obviously.
Subject to interpretation of what they mean and we certainly would want to clarify that with the.
The FDA from our perspective, the concede that the patient population in terms of receptor subtypes. The presentation representative of the U S population, whether they have additional concerns above representation of.
Geographic location that none of the centers were done in the U S debt will be of discussion.
They did not mentioned the geographic location.
A specific issue all along the interaction with the FDA.
So.
Whether you require.
The whole study be done in the U S. Not we will have to carry the <unk> with them in the in the meeting.
Got it and second question.
Seems like the stereotypes multiple issues here, how should we be thinking about the relative weighting of the fda's concerns over each of these issues.
But wonder if that's from the reverse order of how it's listed in the press release any color here would be helpful. Thank you.
I think I think it is an interesting observation because each of those two issue on its own.
Rather.
Uh huh.
Not as clear cut as we would like to hear from the agency the risk issue the.
The.
Of the myeloid toxicity day in my myeloid toxicity is unknown.
Pharmacologically fat of Paclitaxel.
The IV late the fact that hepatic impaired patients.
More sensitive is also well documented in the labeling of IV paclitaxel. So those are not the pricing things and clinician generally can handle it.
Knowing that it's.
The pharmacologic effect and having more of.
<unk>.
Yeah.
Tcs App available.
In the current nowadays.
And so certainly is a surprise to us that they did not have stepped debt by limiting the labeling.
On the hepatic impaired patients debt at.
The address.
Their concern.
The the.
The <unk>.
The other issue of the.
Radiologic concern is even more complex.
We use industry standard.
Blinded independent Central review.
Which is completely independent and totally the readers of totally blinded and the process are well documented and is.
Frustrating for us to hear that they are concerned about the process, especially having weakness them.
All of our process, including process in the <unk>.
In this aspect of having all of the to the clinical sites conducting the study and having all of the bio imaging lab. The conduct these independent blinded process and steel.
Feels that the.
And that should.
Biased debt that they cannot articulate clearly so clearly we have to current five with the agency what constitute a mesh and the bias after hotels like the risk inspection of the process and the independency of the REIT. So.
We will be certainly tried to Kevin.
Explanation from the agency on the wheel on debt during our discussion with them.
Yes.
Okay about the.
While I think the third item really the thought of items that trial and the trial is as indicated we will be discussing with them what they CSN.
Adequate and well conduct the trial.
Jonathan Let me provide you some data and some color.
In addition to total <unk> comment so the first quantity of product was the.
The neutral opinion related part of it in terms of the.
The effect in the.
With the part of the study.
One of the biodiesel toxicity toxicity. So just for your information within the first 19 weeks of the trial.
Sure we have the all of you.
The response to raise price right.
The death rates will eventually very similar roughly around 9% for IV paclitaxel in the 8% for the oral paclitaxel of each.
Types of mortality. So basically I think that are the two ways of looking at the module boxes. The toxicity, we think the upside effect due to the neutropenia and also the all for benefit for the patients.
In fact for the first 19 weeks in terms of mortality there was not much different at all in fact I mean.
The higher for each of the unexpected Texel now to remind you about the <unk>.
Our presentation in the same total meetings, we already presented at the rates, we import neutropenia for oral paclitaxel, what's up 30% and for IV Paclitaxel was up 20.
2% so of defense of one 8%. So these are the inflammation, we wanted to share with you certainly in the risk benefit ratio analysis, we need to also see look for every single risks involved I guess the highly appropriate at the same time, the other subtle and of this related to we do.
Neuropathy and debt a substantial or significant increase in the response rate and.
Also the use.
<unk> should also be consider and where could the bring disappoints of for discussion with the FDA in terms of the oil for assessment of the risk benefit ratio.
Got it thanks for taking my questions.
Thank you Jonathan.
Thank you. Our next question comes from the line of Kennan Mackay with RBC capital markets. Please proceed with your question.
A couple of questions here.
John So just sort of first and foremost.
Would love to understand how.
Do you plan to maximize shareholder value.
From.
Sure.
Yeah.
It seems like the Fda's request for another randomized clinical trial to be prohibitively expensive.
Just wondering one what other funding options are to pursue continued of rock salt development beyond the more debt I would certainly think there would be a value and potentially the strategic interest in your generics or manufacturing business or or other.
The remaining of course here geographies and then I have a subsequent question on the the FDA feedback of Mr. Euro.
Certainly we have.
So we believe the data we believe we have very.
Good data with regard to the benefit and and also.
The risks involved are all within our expectations because of neutropenia is.
The Nicholas from base side effect of deemed to offer any sort of the toxic effects of texel.
Certainly we will go ahead, and then talk about the.
Discussion with FDA, we will be presenting the data and then try to seek the yeah.
The feedback we believe that that we have clung true Hawaii more day to hopefully they will consider debt there is sufficient in terms of changing.
Already but its not there I mean, they did not specify with regard to the nature of the study more RFP. The use of work control study actually index in debit Commendation. So we would like to seek the feedback with regard to what type of study will be.
To set aside for them.
So sort of recommend by a former sort of.
Question in terms of where the Apollo study of a smaller nature of showing the same direction for the same time showing certain directions debt recommended by the FDA will be able to provide data to their set of section of this remains to be discussed now if it's a small study we will be will be in the position we made.
The position to support it the search.
It is a big study.
Our professionals, we will have to reconsider with regard to helping the study the financial implications the timing wall and also the competing nature of our other programs as well as the competitive landscape before we can make a firm decision.
I apologize if I'm, giving you a long answer but the admin affect us of consider in particular the response from the FDA before we can have.
Any clarity after our analysis, we picked up the how would you assess of pushing this program forward.
Sure.
<unk> done that.
Great and my second question is it seems like that.
Feedback in the CRA all of it was certainly a huge surprise to me given you're proud of interactions and.
Even some of their such as granting that the shortening of priority review.
So it's for maybe for you Jonathan as well as Rudolph how do you reconcile your prior apparently positive reaction from communications with the FDA on this trial design and cost of your 2018 press release literally titled <unk> received positive feedback from FDA on design of Phase III clinical trial for Exxon.
And also the FDA granting that prestigious priority review and lack of an advisory committee meeting or the <unk>.
With this BRL requesting a trial representative of the U S patient population in the US standard of care. It seems like somewhere very mixed messaging or cross wires.
Thank you Rudolf do you want to address this question.
Absolutely I think I think the we clearly have discussed with the FDA about the study design and the.
The fact that is not conducted in U S because of the comparator arm.
With the FDA and clearly received written documentation from them confirming that.
One single studies as we pull post is sufficient should the results be positive and that the the second car.
Considering the really the benefit of resets shown by the data and certainly when we submit the that the MTA package all the information we are talking debt.
They have seen.
Include in the submission so whole dose safety data neutropenia data that we please send using Antonio in the survival analysis of all the submission package and the <unk>.
We waited for the stand at 60 days to a non <unk> of the submission and gave US the power till the deal. So all of those were very positive and certainly along the way.
I cannot explain the a lot of those for example of the Milo toxicity, which is known well documented and we come up with a proposal that we can minimize debt.
And the and in the Central lab the.
Hung up on on the Golden standard in the in the industry. We don't know what the hung up east and southern extend debt. We also offer to say debt.
Even if you take into the worst case scenario debt there.
Relief there were only a minimal number of which were too.
One of the change of itself and if you incorporate that we saw change in there it actually faithful our actual more so we don't know what the hand hung up is <unk>.
Completely confused by this change so.
We will we will clarify debt with the agency going forward I think.
I suspect the reading of the left that is purely of my suspicion that are focusing on the U S population in the letter that they perhaps are looking for some more U S. Data that is purely of my speculation at this time point.
Rudolph one one follow up on that it seems like some of the.
CERN around buyers in the blinded review of introduction of buyers there.
It could be mitigated by just looking at some of the overall survival data rich.
Obviously the <unk>.
Just wondering on.
<unk> for <unk>.
Specter of on that overall survival.
The data and then.
The second secondary to that just thinking about the U S population to your point obviously.
Much more.
Use of <unk>.
Yes, the gross doctors to prevent some of the neutropenia, if you were thinking about.
Running the trial, whether single arm or double arm in the U S. Again building off the experience of <unk>.
<unk> from the trial, what kind of things could you add to the protocol to limit.
Some of these adverse events like neutropenia, but we saw some of the <unk> Gi talks.
And at least in the first half of the.
The prior phase three.
Yes.
Yeah.
This is very interesting the D. We have always sort of you have ongoing studies in the U S.
For example, the I spy two.
For example, the angiosarcoma.
The program, which we are collecting more and more experience in the U S patient population, even the Seb speak and certainly with the U S. A way of a practice.
We haven't and conquer the similar level of Milo toxicity.
In the early stage is seen in the study so perhaps the U S population may keep us.
Handle how the U S clinician.
Can handle the Spectre now this is early stage, so I would be cautious about the but certainly you would expect to hear more about those data as they become more mature, but certainly we certainly watch the safety signal and certainly we are feeling good about the same dosing regimen being used in a much elderly population in the <unk>.
Coma patient population the aiding the.
$60 $70 87, the nineties and and in the I spy two way of with the co administer with multiple other trucks. So we certainly do not see such a.
Worrying signal in those 30 of 30 data that was seen so we'll continue to follow that up and pull post debt whether that can be part of the.
Way that we can understand what they mean by that.
The collecting more of information on the U S population.
Does that answer you had mentioned it.
It doesn't and one final question the.
The sudden rise off some of them.
For a thought up and that's the the angiosarcoma population. This is obviously an area of.
Huge unmet need for a small indication and potentially could see.
Much more the accelerated path to market maybe even.
The faster path to market than in breast cancer now just wondering.
You have approached the FDA.
Our path to market given the population or.
How you could potentially go about that.
We already obtained orphan drug designation from the FDA.
And we are we are very actively completing that study I think we are I. The completed enrollment of about to complete enrollment of the 43 patient single arm study and as you've seen in some of our early of the past.
The results are extremely encouraging.
Really.
Uh Huh, John I'm mistaken income missing the sponsors.
As evidenced by the pictures of a pretty standard in San Antonio and previously in in other medical conferences, and certainly is an area where there is no.
Approved treatment and the wherever it rare disease, so that could be net interesting value to see how the FDA would react to our data debt will be collected MP sent to them with 10, we intend to request the formal meeting with the FDA tool.
Discuss the path forward for this indication they my thesis of rare disease, but also.
Rare disease may be.
The treated differently than the then I'll, let the CS within the agency. So we we certainly will be aggressively progressing the regulatory consultation of debt has been.
Yeah.
Thank you.
Thank you kind of.
Thank you, ladies and gentlemen, two of that for as many questions as possible. We ask that you keep to one question and one pharma of each.
Our next question comes from the line of Robert kind of asked US What's true of Securities. Please proceed with your question.
Hey, guys. Thank you I guess I'm.
Here are my two I guess.
Can we just explore like the worst case scenario and the best case scenario. So under a worst case scenario, where you're forced to do it in other trials do you have an estimate of SKU you know how long that would take you like you're saying of cash through 2023, if that is the possibility would you still explore it if they actually asked for like.
A much more controlled study or a bigger study just because there is of patent expiration for this product.
And then the second question is more on the best case scenario. So can you walk us through the timeline for when Youre going to speak to the F. D. A net and I think you have to get documentation together and some proposals together so it might take some time and then you know.
At times of request the meeting and have the being in how youre going to get paid to the street.
The outcome like for example would you wait until after you have the minute.
Just help us get some book ends unlike.
The best case worst case in the pipeline.
Thank you Robyn I think with regards of the first question. Please on the two leach of concerns from FDA in terms of the usual P&L do you think the Socratic I think we do have data that we believe we can be the case with regard to the fact that this is the mechanism a mechanism based side.
The fact that he is manageable and are there some concern with the a small study with the April to address their concerns and how did these line. Besides of the study with the pay a lot with the Halloween would take and the resources required to handle the particular concern now the.
Concern with regard to the blinded.
Cost of independent Central review, we already percent inflammation together with our sales of CLO debt and tight process, what's being done.
And also well control and all of the process with document.
Mentioned by total of corn the.
The reconsideration process and we read process that they have some concern on the measure of bias.
Not only to patients and when people don't have any change I'll cover later in the.
Process and the other one actually.
If you actually took considerations you did that it actually pick out these of even better. So therefore I think there is some concern with the kind of process. Obviously, we will try opacity in terms of going back to discern the independency of the data we feel.
I mean once the understand how independent of the process is that the the FDA may.
May have a different opinion with regard to the.
Integrity, and the and the quality of our data so with regard to your question on the study. It is a small study and are just looking for direction I'm quite sure of that this can be.
Some of range and obviously, we will try our best to the likelihood to FDA as soon as possible the other.
<unk> already addressed the therefore, the review process by the FDA maybe exercise it.
Now with regard to timeline.
For our submission to FDA and then ask for type a meeting obviously, we need to submit the package of people. We have of timeline I felt for Qantas team is working very hard and we are trying to.
<unk> as soon as possible hopefully within a couple of weeks and then followed by a request.
To FDA and we sincerely hope that FDA will grant us the meeting as soon as possible, but the usual timeline, you're setting guidance at the meeting with the help will be occurring within 30 days. So we are looking into a couple of weeks together.
The the timeline that the FDA would grant us the meeting and I think we will have some carry of Emerson.
And one follow up if I may I mean.
Usually with like.
I think data points like this a lot of times of people get refused to file because there.
The data integrity question of the B. The ICR question did you have any changes with the people you're interacting with between the people that you initially spoke with regarding approval of the trial in 2018.
The acceptance of the filing and then today are there any changes in any kols expert I'm sure you have F. The advisers, who advise you on filings what are they saying about the situation. It seems like we've seen this happened once before in the space from a recently, where there's been a surprise.
Yes.
Peter side, so just maybe some of them.
Color there would be really helpful for us.
Right.
As far as I recall, when we submit the protocol more than two years ago to the FDA.
It was a nice upsides of the price wise, because we expect to have a conversation with FDA with regard to the protocol.
We received the letter I think in early January that the.
<unk>.
Send us a letter saying that the.
But at least on the on what you have something on the protocol and the if I remember correctly the comment was that we.
Meet the primary endpoint and demonstrated the risk benefit ratio. The some of these line is adequate for FDA to consider approving the product and it was a very simple two centers in the specter of debt that we have received followed by the standard information with regard to the other aspect of phase one.
Our other requirements to the to be follow so that was the basis of the the letter that we received and the press release that we see of based on the information available.
The latter no I mean.
I mean with that then.
Debbie other wet mopping.
Many of things attach in debt.
And then followed by a number of developments with regard to the submission meeting followed by the subsequent discussion of sensor.
Talk of Quanta is leading the effort I'll, let the quantity of rest of question with regard to whether this change in personnel.
From the early stage two recently with the adapt to the review process for Quanta.
Stephanie.
I think those would be fair to say, we don't think debt any change in personnel from the submission we had a pre submission type C meeting with the FDA to discuss the <unk> and everything.
To the.
The process along the way.
I cannot remember the 2018 meeting where the tenants for the group.
We're essentially similar that I cannot answer.
Okay. Thank you thanks.
Thank you Robyn.
Thank you. Our next question comes from the line of Kevin <unk> with Oppenheimer. Please proceed with your question.
Hey, guys. Thanks for taking my question.
<unk>.
Rudolph one of the areas of differentiation and our work was the neuropathy profile for the oral paclitaxel.
Any comment or are you.
Light you could shed as the weather that was viewed by the FDA has.
Material consideration and the benefit risk profile for patients.
I think.
Kevin My interpretation.
And B when we make the submission debt then when day.
<unk> as a policy of reveal.
They would have.
Scene and understand that pulp is what drives it.
Neuropathy and as Youll see in this thing and total Neil <unk> 'twenty.
I think we pulp the update of the continually seeing fall on the show that the PTT. The neuropathy is clear the differentiating.
And <unk>.
I still have to see.
And the other approach in the tax in the area, where you can differentiate the.
Uropathy in such a way.
<unk> the new new.
Pin the.
Uh-huh.
Profile and also in view of the.
The.
The.
Efficacy benefit we have weakness in the study so thats true the.
Intriguing day.
French facing sector, which has been echoed by all of the Kols, we have to talk with.
So your question is whether the FDA analogy.
Assume they would have of knowledge it when the assigned the policy of reveal the.
Certainly that has not been raised in the discussion along the way so.
It's something we believe we raised with the FDA when one two or <unk>.
Benefit free.
Assessment.
Half of that should provide more evidence and we certainly intend to discuss with kols in.
In the U S how that can be.
Feel from the clinician side. So thank you for asking the question.
Great and my follow up question building on the comments from my colleagues that you.
Suggest that at least in my view as well because it seems to be largely of U S day at a question.
Can you remind us the with regard to the regulatory strategy for jurisdictions outside the U S.
And was that recognize it is not ideal to have the CR.
Oh, well engage and regulators and the other jurisdictions, but yes.
Clearly the modes of delivery of care for for patients are different in different jurisdictions and.
Yes, there would seem to be of strong risk benefit analysis to take to other regulators and the other jurisdictions as well.
Absolutely the dilution will be what we are actively exploring.
Within the.
The DT at the.
The company, we certainly were exploring.
The <unk>.
Uh huh.
By the way is that UK debt recently.
And leave the European Union following Brexit. So those are the bad news that we will actively be pursuing and certainly previously we our partnership interest with the Australian and it will sit in.
Agency and we will continue to explore that and also in the other Asia area Taiwan.
Uh huh.
We had how partner had an interest shouldnt before and we are expecting our partner in China essentially at the start negotiating with the China, FDA, where we have the <unk> or actual in China. So those are the bad news that we were pursuing and we certainly will.
Present, our case of the FDA.
Sponsor.
The 222 debit helpful for Ot to see what are the different interpretation they might the profile of the true up.
Is actually may potentially be ideal for countries that have <unk>.
Health care system, where the the use of an oral.
<unk> made a significant additional benefit of part of the clinical benefit to the health care system. So we will actively explore those options.
Got it thank you.
Thank you. Our next question comes from the line of Yale Jen with Laidlaw <unk> Company. Please proceed with your question.
Good morning, and thanks for taking the questions.
Excuse me.
For my first question is that the given given the abraxas, although that's about all of more than a decade ago was approved mainly based on the data from the Russia in the Ukraine, which account for more than two third of the population studied the.
And is debt.
Issued you would think that the FDA wanted to have.
Slightly more U S population and the that will be the.
The sort of data set they will consider vs. They need something completely in the U S for a much larger study.
Yes.
Well clearly discussed with them.
Think of them.
The way the would it as I read it is representative of the U S population not current.
Contact the in the U S now what do they mean by that the certainly.
The topic for discussion and certainly at the representation is acceptable and debt. It is not the and tie the U S. A study that allows more flexibility in operation, but it all be the buy stock in terms of the debt.
Postal debt may be accepted all of them what they like so I would.
The publicly answer that with better clarity once we had our meeting with the FDA.
Okay. That's very helpful and the one more follow up question here is that the.
We certainly recognize the blinded of review is the gold standard.
And.
And it's not that clear why FDA has reviewed suggest that they may be bias introduced so in your future meetings with the agency would you be able to add more specifics of what they have seen.
The so called of buyers potential buyers being introduced so you'll have a better sense of what they really need.
Absolutely and that's an interesting dialogue that I would anticipate because in the old days, maybe even the apex study when the FDA is not certain the property would.
Look at the radio graph themselves right or relative.
Until independent lap when these investigator initiated in this case, we already use the state of the art. They mined the essential REIT process is very straight.
We used two independent readers that are trained in the six.
That's really kind of bear in mind. The investigators are not always 40 of the day in training. This is the clinical practice with the CP search, whereas in the Central lab, they were fully trained and day.
With the scans following Britain procedures debt come.
Complete the line that way.
And and the reading has to correlate and the state don't correlate 10 of 13 dependent read of complete declined with two of the case of all of those process a really state of the art. So I am stuck go to find out how we can.
Our move away from those and measure of both buy and measurable bias because in the old days, the FDA, probably what the uptime in obviously in this case they didn't have time with Hep.
And the that the scans and analyze the himself and properly collaborate what the the flattening of the wedge of individuals central would have done and I don't know how one can certainly is a question we will explore with the FDA, whether they wanted to the parcel of they want to to assign an additional central and have to look at the skin those topics will be something that will raise.
Okay, great. Thanks, a lot and the best of luck well move forward.
<unk>.
Thank you.
Thank you. Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.
Oh, Hi, this is Raymond in for Matt just a quick question and one more follow up is I was wondering if the if you could provide any additional color on the dose optimization language that the agency provided.
Without.
No certainly not I think we did discuss I think we did discuss the.
Early stage when we talk about the with the agency of about the the labeling language for those.
Hosting then there was the question how those adjustments.
Should be made in patients with hepatic impairment and we proposed to use it as in the protocol and Thats, what we did and so that was the open the discussion we had with them and so I presume. This will be of follow on of what kind of dose optimization would be.
Consider the best for those higher risk group, just reading the language of.
With the needs of questions that we want to clarify with them.
Okay and just my follow up is.
Perhaps the impact on just the pipeline in general do the.
The language from the FTA, perhaps you can kind of.
The price and additional color on that.
Let me answer the question the two questions that were asked.
One was being the on Paclitaxel of specific.
The adverse events of side effects and the second one was the.
Question on making sure that the.
By the independent Central review was a source of.
Appropriate according to the assessment.
None of them are really tied to the technology platform that we are working on right now. So therefore based on this assessment.
It should not be.
That will free up to the platform and how we're going to pursue other programs. The suddenly I mean, when is something to tie into our platform. The inmates use there and we obviously will have to work through and ensure that we provide sufficient data to.
Make sure that the confidence.
What is the result, all up for both of investors for the retrofit agencies for patient central conditions.
Okay. Thank you thank.
Thank you.
Thank you ladies and gentlemen, this concludes our question and answer session.
Turn the floor back to Dr. Low for any final comments.
Thank you.
During the last three months, we have had the approval and launch of <unk> and we see the complete response letter from the FDA on oral Paclitaxel.
Our team will continue working towards the possible work with FDA to address the concerns on the oral paclitaxel and the package.
At the same time, we are working to identify other pick.
The appropriate internal.
The organizational adjustments accordingly, and we will communicate information regarding this inflammation when more information is available.
Thank you for your time in joining us the call. This morning.
Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.