Q2 2019 Earnings Call
Unknown Executive: Special Conference Call for the second quarter of 2019. At this time, all participants are in a listen-only mode. A brief 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.
At this time, all participants are in listen only mode.
A brief question and answer session will follow the formal presentation.
If I knew what require operator assistance during the conference. Please press star zero in a telephone keypad as a reminder, this conference is being recorded.
Unknown Executive: As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Dolly Vance, who is Rigel's Executive Vice President, Corporate Affairs, and General Counsel. Thank you, Ms. Vance. You may begin.
It is now my pleasure to introduce our first speaker Dolly Vance, who is Rogers executive Vice President Corporate Affairs and General Counsel. Thank you Ms. Vance you may begin.
Welcome to our financial results and business update conference call.
Unknown Executive: Welcome to our Financial Results and Business Update Conference Call. The financial press release for the second quarter of 2019 was issued a short while ago and can be viewed, along with the accompanying slides for this presentation, in the News and Events section of our Investor Relations page on our website at www.rigel.com.
The financial press release for the second quarter of 2019 was issued a short while ago and can be viewed along with the accompanying slides for this presentation and the news and events section of our Investor Relations page on our website at Www Dot Rigel Dot com.
Unknown Executive: As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent quarterly report on Form 10-Q, on file with the SEC. Any forward-looking statements are made only as of today, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I would like to turn the call over to our CEO, Raul Rodriguez.
As a reminder, during today's call we may make forward looking statements regarding our financial outlook, and our plans and timing for regulatory and product development.
These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
A description of these risks can be found in our most recent quarterly report on Form 10-Q on file with the FCC.
Any forward looking statements are made only as of today's date and we undertake no obligation to update these forward looking statements to reflect subsequent events or circumstances.
At this time I would like to turn the call over to our CEO Raul Rodriguez.
Thank you Dolly and thank you for joining us on our second quarter 2019 financial and business update call.
Raul R. Rodriguez: Thank you, Dolly, and thank you for joining us on our second quarter 2019 financial and business update call. Also joining me on the call today are Elden Mayer, our Chief Commercial Officer, Anne-Marie DuLiage, our Chief Medical Officer, and Dean Schorno, our Chief Financial Officer. I'd like to start with slide five.
Also joining me on the call today are holding Mayer, our chief commercial officer.
And Murray do the Azure, our Chief Medical Officer, and didn't short no our chief Financial Officer.
I'd like to start with slide five.
Regardless, focusing on developing opportunities that will drive both near term and long term value.
Raul R. Rodriguez: Rigel is focusing on developing opportunities that will drive both near-term and long-term value for the company and its shareholders. Our main priority now is execution, so let me show you how we're going to do that.
And we have a clear path to creating this value for the company and its shareholders.
Our main priority now is execution. So let me show you, how we're going to do that.
Raul R. Rodriguez: From a commercial perspective, we brought Tavaleese to the market approximately 12 months ago. Cavalisse is the first approved sick inhibitor for the treatment of ITP. Tavlis is highly differentiated as the only therapy that prevents the body's immune system from destroying its own platelets and so addresses the underlying pathophysiology of this disease.
From a commercial perspective, we brought top at least to the market approximately 12 months ago.
Police is the first approved syk inhibitor for the treatment of by TPM.
But at least it's highly differentiated as the only therapy that prevents the body's immune system from destroying its own platelets.
And so addresses the underlying pathophysiology of this disease.
Raul R. Rodriguez: Chronica Adult ITP is a billion-dollar market in the U.S., and we're establishing ourselves in this rare disease market with an important medical need, and we are gaining market share. As we look at other opportunities for revenue generation, we are focusing on expanding the range of potential indications for Tavale. We believe that sick inhibition plays an important role in a number of other immune-mediated diseases.
Chronic oh adult I T. P is a billion dollar market in the U.S., we're establishing ourselves in this rare disease market with important unmet medical need and we are gaining market share.
As we look at other opportunities for revenue generation, we are focusing on expanding the range of potential indications for top on lease.
We believe that sick inhibition plays an important role in a number of other immune mediated diseases.
Our plan is to continue development efforts, our new indications such as auto immune hemolytic anemia and others.
Raul R. Rodriguez: Our plan is to continue development efforts on new indications such as autoimmune hemolytic anemia and others. The investment is worthwhile since Palvelis has exclusivity until 2031. Our pipeline of opportunities comes from Rydges Proprietary Research, the foundation of the company. We are proud of our research and development accomplishments to date and their contributions towards creating further long-term value for the company. Going on to slide 6, we are executing to drive value for RIGEL. Sales were $10.2 million in the second quarter, which was a 26% growth from Q1.
The investment is worthwhile since top Elise has exclusivity until 2031.
Our pipeline of opportunities come from Reits per tire proprietary research the foundation of the company.
We are proud of our research and development of accomplishments to date.
And their contributions towards creating further long term value for the company.
Going on to slide six.
We are executing to drive value for rigel.
Sales were 10, Mil 10.2 million in the first and the second quarter, which was a 26% growth from Q1.
Raul R. Rodriguez: Clearly, the launch is going quite well. We're also seeing growing awareness for Tavalllis, including understanding optimal dosing, duration of treatment, and broader use amongst physicians and patients. These trends are exciting in regards to our future growth potential. We continue to progress with the EMA approval process, and we are responding to the Day 180 questions. Based on the expected timeline, we should have a decision by the end of the year, which could potentially mean a sizable milestone, as well as a royalty stream from Europe beginning next year.
Clearly the launch is going quite well.
We're also seeing growing awareness for topics, including understanding optimal dosing duration of treatment and broader use amongst physicians and patients. These trends are exciting in regards to our future growth potential.
We continue to progress with <unk>. He may EMA approval process and we are responding to the day when 80 questions based on the expected timeline, we should have a decision from the EMA by the end of the year, which could potentially mean, a sizable milestones as well as the royalty stream from Europe , beginning next year.
On the last call, we announced at the sites for our Phase three trial in Ha open and subsequently we announced the enrollment of the first patients.
Raul R. Rodriguez: On the last call, we announced that the sites for our Phase 3 trial in AIHA opened, and subsequently, we announced the enrollment of the first patient. We have been very strategic in our approach to this trial enrollment in order to complete this in a timely manner. Anne-Marie will discuss this further in greater detail. Moving on to slide seven.
We have seen very been very strategic in our approach to this trial enrollment in order to complete this in a timely manner and Marie will discuss this further in greater detail.
Going on to slide seven.
Raul R. Rodriguez: Before Eldon dives into the commercial business, I'd like to talk a little bit about the opportunity in warm autoimmune hemolytic anemia and why we're so excited about this indication. First, based on external market research, this market has the potential to be a billion-dollar market. The patient population is approximately 40,000. And with no FDA-approved therapies for this disease, this is a clear unmet medical need. Tavalisse may begin to address this important unmet need, and it's already shown a benefit in its Phase II clinical trials. Similar to ITP, steroids are the primary option for patients today, but they are known to have side effects that are difficult to manage, especially in the long term. And so they are not an optimal choice for chronic treatment.
Before elden draw dives into the commercial business I'd like to talk a little bit about the opportunity in warm autoimmune hemolytic anemia, and why we're so excited about the syndication.
First based on external market research this market has potential to be a billion dollar market.
The patient population is approximately 40000.
And with no FDIC approved therapies for this disease. This is a clear unmet medical need.
To have at least may bring begin to address this important unmet need and how it's already showing a benefit in its phase two clinical trials.
Similar to I T. P. Steroids are the primary option for patients today, but they are known to have side effects that are difficult to manage especially in the long term.
And so they are not an optimal choice for chronic treatment.
Eldon: Potentially becoming the first product approved for warm autoimmune hemolytic anemia with a safety profile for long-term use would provide a significant advantage for Rigel in this market. Finally, the AIHA opportunity is extremely synergistic with Tavalese and ITP. The physicians that treat ITP are also the ones that treat AIHA. Our team is already educating the market on sickle cell inhibition in ITP, and the mechanism of action is similar in AIHA. We have a commercial infrastructure already in place, so it would require minimal change to begin selling Tavalese for warm autoimmune hemolytic anemia. So with that, I'd like to turn the call over to Eldon for an update on our commercial progress and the exciting inroads we're making with Taviliz.
Potentially becoming the first product approved for warm autoimmune hemolytic anemia with a safety profile for long term use.
Would provide a significant advantages for rigel in this market.
Finally be a ci opportunity, it's extremely synergistic with top at least an i. TP.
The physicians that treat RTP are also the ones that treat ha.
Our team is already educating the market on sick inhibition denied T P and the mechanism of action is similar in AI Ajay.
We have been have a commercial infrastructure already in place you would require minimal changes to begin selling today at least for warm autoimmune hemolytic anemia.
So with that I'd like to turn the call over to Elden for an update on our commercial progress and the exciting inroads, we're making with Teletubbies Holden.
Thanks Ross.
Eldon: Thanks, Raul. It was a great quarter for Tavalis following a significant uptake in the first year of commercialization. Our Q2 product sales were strong, with bottles shipped up 25% over Q2, bringing in $10.2 million in net revenues. Importantly, we continue to see strong persistency. Our patient refill rate for Tavalis at four months suggests that approximately half the patients are receiving a benefit with manageable side effects. As a product in its commercial infancy, we believe this is very encouraging. With further experience and knowledge of the product among HCPs, as well as use in earlier lines of therapy, we believe there's potential for this to improve over time. To that end, we continue to see trends toward using it in earlier lines of therapy.
It was a great quarter for top Elise following a significant uptake in the first year of commercialization.
Our Q2 product sales were strong with bottles shipped up 25% over Q2, bringing in 10.2 million net revenues importantly, we continue to see strong persistency.
Our patient refill rate for top at least four months suggest that approximately half the patients are receiving a benefit with manageable side effects as a product and its commercial entity. We believe this is very encouraging with further experience and knowledge of the product the money she piece as well as use in earlier lines of therapy. We believe there is potential for this to improve overtime.
To that end, we continued to see trends towards use in earlier lines of therapy.
Eldon: The next two lines of therapy in the post-steroid market comprise about 75% of the addressable market, so it's critical that we capture a significant share of this subset of patients. We believe it's very achievable, given the Tavelis product profile and the unmet need in this market. We're also seeing expansion of the prescriber base, good repeat prescribers year-to-date, and consistency of adding new prescribers quarter-over-quarter, all of which can be attributed to the positive results that physicians and patients are having with Tavalese, as well as strong execution of our customer-facing team. Next slide.
The next two lines of therapy in the post dairy market comprised about 75% of the addressable market.
So it's critical that we capture a significant share of the subset of patients I believe is very achievable given the top at least product profile and the unmet need in this market.
We're also seeing expansion of the prescriber base, good repeat prescribers year to date and consistency of adding new prescribers quarter over quarter, all of which can be attributed to the positive result that physicians and patients are having with hobble lease as well as strong execution of our customer facing teams.
Next slide.
When we entered the market at the first product in 10 years with a different mechanism of action, we had the challenge of changing the mindset and the habit of physicians patients and payers and just one year. We've seen our efforts have an impact on how physicians are thinking about IP treatment. How patients are looking at their options and how payers are valuing our product our core objectives have been too.
Eldon: When Tavaly's entered the market as the first product in 10 years with a different mechanism of action, we had the challenge of changing the mindset and the habits of physicians, patients, and payers. In just one year, we've seen our efforts have an impact on how physicians are thinking about ITP treatment, how patients are looking at their options, and how payers are valuing our product. Our core objectives have been to, number one, highlight the different mechanism of action that addresses the destruction of platelets and, number two, communicate the benefit of Tavalys across lines of therapy. Three, educate patients on dose titration to achieve an optimal benefit, as well as the ability of our product to be used continuously to address the chronic nature of this disease. And four, support access and adherence.
Number one highlight a different mechanism of action that addresses the destruction of platelets number to communicate the benefit of top lease across lines of therapy, three educate on dose titration to achieve an awful benefit as well as the ability of our product to be used.
Continuously to address the chronic nature of this disease and for support access and adherence one of the ways in which we are doing this is through Roger one care, our physician and patient assistance center and the support programs.
Eldon: One of the ways in which we're doing this is through RIGEL OneCare, our physician and patient assistance center and its support program. These efforts have led to a positive perception of Topolis by the ITP community, as demonstrated by the following. Physicians recognize this is a very different product compared to others, and many physicians agree that preventing the destruction of platelets is an important way to treat ITP, as opposed to stimulating the bone marrow to increase platelet production or by weakening the immune system to slow the destruction of platelets.
These efforts have led to a positive perception of top lease by the ITC.
Immunity at us as demonstrated by the following.
Physicians recognize this is a very different product compared to others and many physicians agree that preventing the destruction of platelets as an important way to treat I compete as opposed to stimulating the bone marrow to increase platelet production or by weakening the immune system to slow the destruction of platelets.
Eldon: Additionally, patients are expressing their excitement for another treatment option. While we have an attractive safety profile and convenient oral dosing that patients can really appreciate, we're also demonstrating a meaningful clinical benefit. And finally, since launch, payers have shown they understand the value of our product, and coverage continues to be strong. Next slide.
Additionally.
Patients are expressing their excitement for another treatment option, while we have an attractive safety safety profile and convenient oral dosing. The patients can really appreciate we're also demonstrating meaningful clinical benefit and finally since launch Paris have shown they understand the value of our product and coverage continues to be strong.
Next slide.
Obviously, you don't drive change overnight with a physician.
Eldon: Obviously, you don't drive change overnight with a physician and patient community. A majority tend to demonstrate caution when a new treatment comes to market and need to fully understand a product or a way to see the type of success early adopters are having. To address this, we continue to drive physician access and awareness and create as many touch points as possible. For example, we... We support physician peer-to-peer education, particularly among those engaging in the initial use of Tavalese, so that they have the knowledge and confidence to titrate and treat patients successfully. Here on this slide is a real-world example of how our multiple points of direct and indirect engagement, including exposure at conferences, sales force engagement, peer-to-peer engagement, and experience, converted a physician into a repeat prescriber. Initially, the physician learned of Tablis at our exhibit boat booth at ASCO.
And patient community a majority tend to demonstrate caution when a new treatment comes to market and need to fully understand the product or wait to see the type of success early adopters are having to address this we continue to drive physician access and awareness and create as many touchpoints as possible.
For example, we could.
We support physician peer to peer education, particularly among those engaging initially set top beliefs.
So that they have the knowledge and confidence to titrate and treat patients successfully here on this slide is a real World example of how our multiple points of direct indirect engagement, including exposure at conferences Salesforce engagement peer to peer engagement and experience converted a physician to repeat prescriber.
Initially the physician learned of top lease at our exhibit booth at ASCO.
Eldon: They then received a follow-up from Rigel and identified an appropriate patient. The patient received a meaningful clinical benefit after a short time on treatment, and the physician gained further confidence through peer-to-peer speaker forums and is now using Copolis more broadly across numerous patient types and lines of therapy. And this next slide is another real-world example of how we are successfully reaching physicians and how experience and education of optimal dosing are resulting in patients benefiting from treatment with Tavolese. This doctor was recommended Topolis by a peer who had success using it with different patients across various lines of therapy. A patient was identified who was frustrated with her current therapy and then switched from the TPO drug to tabliliz. The patient experienced a modest benefit in the first month, but the physician spoke to a colleague who suggested titrating the dosetopolys up to 150 mg BID and then extended the treatment for up to 12 weeks before potentially discontinuing. The patient received a clinically meaningful response and continues on treatment today. Final slide.
Hey, Ben received a follow up from Rigel and identified an appropriate patient.
Patient received a meaningful clinical benefit after a short time on treatment.
And the physician gain further confidence or peer to peer speaker forms and is now using cavalese more broadly across numerous patient types and lines of therapy.
And on this next slide is another real World example of how we are successfully reaching physicians at her experience and education of optimal dosing are resulting in patients benefiting from treatment with takeaways.
This physician was recommended top lease by peer that success using it with different patients across various lines of therapy.
The patient was identified it was frustrated with the current therapy, and then switched from a tipo drug to cobble lease.
The patient experience a modest benefit in the first month.
But the physician spoke to a colleague for suggest a tight trading windows top lease up to 150 milligram VIP and then extended treatment for up to 12 weeks before potentially just continuing.
Patient received a clinically meaningful response it continues on treatment today.
Final slide.
Eldon: To summarize, our success to date has been driven by the broad efforts of our customer-facing team. It's also important to note that over time, our team has gained and will continue to gain additional tools to help educate and change the mindset of physicians who have been using the same products for years with varying degrees of success. We believe engagement, experience, and education are essential components that will drive our market share growth in the coming quarters, and these efforts continue to increase and improve over time. Since the beginning, the sales team has been the foundation of Tavalee's success and will continue to be the main driver of uptake. However, other channels of physician engagement are also important in growing awareness and adoption, and we are very active with speaker bureaus and at medical conferences.
To summarize our success to date has been driven by the broad efforts of our customer facing teams.
It's also important to note that over time, our team has gained and we'll continue to gain additional tools to help educate and change the mindset of physicians, who have been using the same products for years with varying degrees of success. We believe engagement experience and education are essential components that will drive our market share growth in the coming quarters and these efforts continue to increase and improve over time.
Since the beginning the sales team has been the foundation of Taobao lease success and will continue to be the main driver of uptake. However, other channels physician engagement are also important and growing awareness and adoption and we are very active with Speaker Bureau, and at medical conferences. We continue to hear Taobao. These success stories and see physicians sharing their experiences which are driving use and increased interest and.
Eldon: We continue to hear Tavoli success stories and see physicians sharing their experiences, which are driving use and increased interest. By continuing to educate the market and grow our database with insights from our extension study and post-hoc analysis, publications, and educational programs, we believe we can attract further physician interest and continue to change the mindset of prescribers. I would also like to point out that we are not just educating the market on our product; we are also educating ourselves on the market. Through education, the Advisory Board, and ongoing market research, we continue to grow our understanding of the market, which we believe will help us to achieve a leading market position for Topolese. Thank you. Emory
By continuing to educate the market and grow our database with insights from our extension study in post talk analysis publications and educational programs. We believe we can attract further physician interest.
And continue to change the mindset of prescribers.
I would also like to point out that we are not just educating the market on our product. We are also educating ourselves on the market through educational.
Advisory Board.
And ongoing market research, we continue to grow our understanding of the market, which we believe will help us to achieve a leading market position for takeaway. Thank you.
And Murray.
Thank you well done.
I would like to walk you through our initiatives on the clinical development sites that have the potential to create meaningful near term value for rigel.
Anne-Marie: Thank you, Eldon. I would like to walk you through our initiatives on the clinical development side that have the potential to create meaningful near-term value for Rigel. As an update, we remain on track for the EMA's decision on our marketing authorization application for Fostamadenib in chronic ITP. We have been collaborating with Grifo as they prepare for the potential launch in Europe. And, with the lead time they have, as well as the relationships and infrastructure they have established over the years, revenue generation in Europe could begin next year.
As an update we remain on track with the with we remain on track for the emails decision on our marketing authorization application for Fostamatinib in chronic ITP.
We have been collaborating with reefal as they prepare for the potential launch in Europe .
And we do lead time, they had as well as the relationships and infrastructure they have established over the years.
Revenue generation in Europe .
Could begin next year.
Anne-Marie: KISE is moving along as well, working to finalize the trial protocol for a bridging study in Japan. Based on their expectations for the trial, they expect to be in a position to file an NDA by the end of the fourth quarter in 2021 or during the first quarter of 2022. We are also continuing to move forward with the next indication for Taveliz in the U.S., which is warm autoimmune hemorrhagic anemia. We have enrolled the first patient as planned and have several sites that are approved for participation. With enrollment up and running, we're on track to complete enrollment in the middle of next year and have top-line results in 2021. Next slide, slide 16.
Can you say is moving along as well.
Working to finalize the 12 critical for bridging study in Japan.
Based on their expectations for the trial.
We expect to be in a position to file an NDA by the end of the fourth quarter in 2021.
Or during the first quarter of 2022.
We're also continuing to move forward with the next indication for 10 release in the U.S., which is a war two immune hemolytic anemia.
We have enrolled the first patient to plan and have several sites that are approved for participation.
We then enrollment up and running we're on track to complete enrollment in the middle of next year and half topline result.
In 2021.
Next slide slide 16.
Well described why we're so excited about the potential opportunity for Teva lease in warm antibody or to immune hemolytic anemia.
Anne-Marie: Raul described why we're so excited about the potential opportunity for Tavalez in warm antibody autoimmune hemolytic anemia. This is a wide open market, and our goal is to become the first FDA-approved product. In order to achieve this goal, we need to be thorough but also efficient in our Phase 3 trials. We have been able to leverage our experience with ITP to help develop a strategy that we believe will enable us to enroll all 12 in a timely manner. Our trial protocol calls for 80 patients, but we'll be targeting over 90 sites in 22 countries to enroll the trial. Since this is a rare disease, the pool of patients is relatively small. So being aggressive in the number of trial sites we enlist and being thoughtful as to which geographies we utilize will help compensate for potential hurdles.
This is a wide open market and our goal is to become the first and you proof product.
In order to achieve this goal we need to be so but also efficient in our phase three trial.
We have been able to leverage our experience with IP to help develop the strategy that we believe will enable us to enroll the trial in a timely manner.
Our 12 critical coal through 80 patients. However, we'll be targeting over 90 sites in 22 countries to enroll the trial.
Since this is a rare disease.
This pool of patients is relatively small.
So being aggressive in the number of 12 sites we had list.
And being thoughtful as to which geographies we utilized.
We'll help compensate for potential hurdle.
With that said the relationships and knowledge, we gained from the ITC trial and the subsequent commercial launch in the U.S.
Anne-Marie: With that said, the relationships and knowledge we gained from the ITP trial and the subsequent commercial launch in the U.S. will also help mitigate potential challenges that come with recruiting from a smaller patient population. Early on, we have seen contributions from our ITP experience, as we have had 9 out of the 11 phase 3 sites in the U.S. enlist in our autoimmune hemodidykinemia trial. Additionally, we have received interest from physicians who have had success treating ITP patients with Tavoliz and understand how the mechanism of action could potentially work well in warm autoimmune hemolytic anemia.
We will also help mitigate potential challenges that come with recruiting from the smaller patient population.
Early on we have seen contributions from our Itps Steven.
As we have had nine out of the 11 phase three sites in the U.S.
And list in our auto immune hemolytic anemia trial.
Additionally, we have received interest from physicians will know that success treating the patients we believe.
And understand how the mechanism affection could potentially work well in a warm auto immune hemolytic anemia.
The 12 is being managed by a CR low that has substantial experience in the field of what two immune hemolytic anemia.
Dean L. Schorno: The trial is being managed by a CRO that has substantial experience in the field of autoimmune hemorrhagic anemia, which we believe provides a significant advantage. Finally, we're being very diligent in selecting trial sites and how we work with them to identify patients. While patient identification is core to any clinical trial site, we're taking extra steps to stay informed on all the potential patients a site will have. Our system enables us to maintain close contact with sites around the time that prospective patients will be making office visits, and we will work with the investigators to make sure that these patients understand the value of Tavalese and are aware of the trial opportunity. Our enrollment efforts are very robust, and we believe they will provide significant value to our execution efforts. I will now turn the call over to Dean Schorno.
Which we believe provide a significant advantage.
Finally, we're being very diligent in selecting 12 sites and how we work with them to identify patients.
While patient identification is core to any clinical trial site.
We're taking as two X two steps to stay informed on older potential patient site will have.
Our system enables us to maintain close contact with sites around the time that prospective patients will be making office visit.
And we will work with investigators to make sure that these patients understand the value of total lease and are aware of the 12 opportunity.
Our enrollment efforts are very robust.
And we believe they will provide significant value to addition efforts.
I will now turn the call over to ensure no.
Dean L. Schorno: Thank you, Anne-Marie. Looking at slide 18, for the second quarter of 2019, we shipped 1,270 bottles to our specialty distributors, resulting in $12.5 million in gross product sales. 1,163 of those bottles were shipped to patients and clinics, while 107 bottles remained in our distribution channels at the end of the quarter. As of June 30th, a total of 436 bottles remained in our distribution channel.
Thank you Anne Marie looking at Slide 18 for the second quarter 2019, we shipped 1270 bottles through our specialty distributors, resulting in $12.5 million of gross product sales 1163 of those bottles were shipped to patients at clinics. While 107 bottles were made in our distribution channels at the end of the quarter.
As of June Thirtyth, a total of 436 bottles or amend our distribution channels.
Dean L. Schorno: We reported net product sales from Tavalease of $10.2 million, which was a recorded net of estimated discounts, chargebacks, rebates, returns, copay assistance, and other allowances of $2.3 million. Our gross to net adjustment, which is 18.5% of gross product sales. This 26% quarterly-over-quarter increase in net product sales of Tavalease reflects the continuing growth of our business since our commercial launch in May of 2018. As a reminder, and as we expected, our first quarter's sequential net product sales growth rate of 10% was impacted by typical first quarter reimbursement issues, such as the resetting of copays and the Medicare donut hole. As a result, our second quarter's sequential net product sales growth rate of 26% was positively impacted. For the third quarter, the sequential growth rate is likely to moderate, as shown on the next slide.
We reported net product sales from top $10.2 million, which was recorded net of estimated discounts chargebacks rebates returns co pay assistance and other allowances of $2.3 million, our gross to net adjustment, which is 18.5.
Percent.
Gross product sales this 26% quarter over quarter increase net product sales of top always reflects the continuing growth of our business since commercial launch in may of 2018.
As a reminder, and as we expected our first quarter support sequential net product sales growth rate of 10% was impacted by a typical first quarter reimbursement initiatives, such as the resetting of content and the Medicare Donut hole.
As a result, our second quarter sequential net product sales growth rate of 26% was positively impacted.
For the third quarter this sequential growth rate is likely to moderate.
On to the next slide.
In addition to our net product sales contract revenues from collaborations were $234000 for the three months ended June Thirtyth 2019.
Dean L. Schorno: In addition to our net product sales, contract revenues from collaborations were $234,000 for the three months ended June 30, 2019, which were related to our collaboration agreements with KeySafe Pharmaceutical Company Ltd. and Gripple's S.A. There were no contract revenues from collaborations during the three months ended June 30, 2018. As a reminder, we entered into a Collaboration Agreement and License Agreement with Grifols during the first quarter of 2019 to commercialize Fostamatinib in Europe.
Which were related to our collaboration agreements with key stage pharmaceutical company limited and grip of asset.
There were no contract revenues from collaborations during the three months ended June Thirtyth 2018.
As a reminder, we entered into the collaboration agreement and license agreement with grip goals. During the first quarter 2019 to commercialize fostamatinib in Europe .
Dean L. Schorno: In the first quarter, we discussed revenue accounting as well as the key terms under the agreement. Moving on to costs and expenses. Our cost of product sales was approximately $311,000 for the second quarter of 2019. Overall, cost and expenses were $31.7 million versus $27.9 million in the second quarter of 2018. The increase in costs was primarily due to increased personnel costs for Rigel's customer-facing team and third-party costs related to the commercial launch of Tavoise and Chronic ITP, as well as R&D costs related to our phase 3 pivotal trial of tavoids in patients with warm autoimmune hemolytic anemia, which was initiated during the quarter. We expect our costs and expenses to increase in the second half of 2019 compared to the first half We ended the quarter with cash and short-term investments of approximately $112.4 million. We currently expect our cash runway to extend into the second half of 2020 and provide for our continued commercial expansion as well as expansion of our clinical programs. With that, I'd like to turn the call back over to Raul.
In the first quarter, we discussed the revenue accounting as well as the key terms under the agreement.
Moving on to costs and expenses our cost of product sales was approximately $311000 for the second quarter of 2019.
Overall cost and expenses were $31.7 million versus $27.9 million in the second quarter of 2018.
The increase in cost was primarily due to increased personnel costs for rigel is customer facing team and third party costs related to the commercial launch of towers and chronic high altitude.
As well as R&D costs related to our phase three pivotal trial tolerated.
In patients with warm autoimmune hemolytic anemia, which was initiated during the quarter.
We expect our cost and expenses increased in the second half of 2019 compared to the first half as we continue to ramp up our activities in our phase three study in warm auto immune hemolytic anemia, and as we continue our commercial expansion on top of it is.
We ended the quarter with cash and short term investments of approximately $112.4 million. We currently expect our cash runway through extended into the second half of 2020 and provide for our continued commercial expansion as well as expansion of our clinical programs.
With that I'd like to turn the call back over to ROE.
Thank you Dean and I am on slide 21.
Raul R. Rodriguez: Thank you, Dean, and I'm on slide 21. I'd like to reemphasize how pleased we are with the performance of Cavalisse in its first year on the market for the treatment of ITP. Our commercial team did an excellent job preparing for the product launch and then executing on that plan, and these efforts are clearly paying off. For our first year, we generated over $32 million in net product revenue, owing to a steady double-digit increase in sales quarter over quarter. That's fantastic!
I'd like to reemphasize, how pleased we are with the performance of top at least in its first year on the market for the treatment of by TP. Our commercial team did an excellent job in preparing for the product launch and then executing on that plan.
And these efforts are clearly paying off.
For our first year, we generated over 32 million and net product revenues.
Moving to steady double digit increase on sales quarter over quarter that's fantastic.
Raul R. Rodriguez: And most importantly, over a thousand patients have been treated with Talvalese to date, and many of them are succeeding on our product. The momentum and trends we are seeing as we emerge from the first year are incredibly encouraging. Slide 22, The results for the first half of 2019 speak for themselves, but let me remind you of our priorities for this entire year. Most importantly, the continued growth of Tavelizu. We are growing awareness of tavelizu amongst physicians and patients alike, and importantly, physicians are gaining experience and becoming more educated on the product and its use, and this will continue to drive increased usage and durability of treatment. For our next indication, AIHA, we are enrolling patients in the pivotal trial for TAVA. We're also working to make fostamatinib available globally, including seeking EU approval for taveliz in ITP and its launch potentially next year. In addition, we have been actively progressing our other pipeline initiatives, and we expect to talk more about these in the coming quarters. With that, I'd like to turn the call over to the operator for your questions.
And most importantly over a thousand patients have been treated with top at least to date and many of them are succeeding on our product.
The momentum and trends we are seeing as we emerged from the first year are incredibly encouraging.
On slide 22.
The results for the first half of 2019 speak for themselves, but let me remind you of our priorities for this entire year.
Most importantly continued growth of top of lease we are growing awareness until the lease amongst physicians and patients alike, and importantly patients physicians arts are gaining experience and becoming more educated on the product and its use and this will continue to drive increased usage and durability of treatment.
For our next indication he I'd say, we are enrolling patients in the pivotal trial for top of these.
We're also working to make fostamatinib available globally.
Including seeking you approval for Tbilisi, My TP and its launch potentially next year.
In addition, we have been actively progressing our other pipeline initiatives and we expect to talk more about these in the coming quarters.
With that I'd like to turn the call over to the operator for your questions.
Thank you, we'll now be conducting a question and answer session.
Unknown Executive: Thank you. We will now be conducting a question and answer session. If you would like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start key. Once again, that is star number one to ask a question today. Our first question today is coming from Eun Yang from Jeffrey's, Your Line is Now Live.
If you had to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.
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For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Once again that is star one to ask a question today.
Our first question today is coming from Union from Jefferies. Your line is that a lot.
Thank you I have a couple of questions. So last October .
Eun Kyung Yang: Thank you. I have a couple of questions.
Eldon: So, last October, you gave us the data pointing to about 16% second-line use and about 25% third-line use. Can you give us an updated number? And also, what percent of patients currently on top of the list are post-tip amniotic?
You gave us the data.
Blinking key above 16% decline used in about 25% below the line.
Can you give us an updated number and also what percentage of patients currently on top of me.
Our goal is to keep problematic.
Eldon: Hi Eun, this is Eldon. I will answer your question as best I can. You know, we haven't revealed any specific metrics by line of therapy since then. I think, as I've mentioned on prior calls, it's the best data that we are continuing to monitor. And as we collect more data, I think that we'll be able to report on that in the future. And we think we have sufficient data to show that those figures are reliable. I can tell you, though, as we monitor it, we are seeing a continued trend towards earlier line treatment. So we are being used across all lines, but we are seeing a gradual movement upward in line.
Yes, Hi, how are you this is Ellen I will.
And to your question and.
Thats like can we havent revealed any specific metrics by line of therapy. Since then I think as I've mentioned on prior calls its best data is we are continuing to monitor and as we collect more data I think that we'll be able to report on that report out on that in the future and we think we have.
Sufficient days those figures are reliable I can tell you, though as we monitor it we are seeing.
Continued.
Trend towards earlier following treatment.
So we are being used across all lines, where we are seeing a gradual movement.
Upward in line also.
Eldon: Also, as you may understand about the market, there are many different styles of treatment. Some doctors prefer to use rituximab or TIPO drugs. And there are many variations. There is a lot of heterogeneity in disease and a lot of variability in treatment. And therefore, there are many different entry points for how our drug can be used. So the usage of our drug is across all lines for a number of reasons. But in part, because physicians have different treatment styles, and they see the value proposition and role for our product differently depending on how they prefer to treat the disease. Again, I hope that helps.
As you may understand about the market there are.
Many different styles of treatment some doctors prefer to use right for a toxin or peak.
Rituximab or or Tipo drugs and there are many variation there is a lot of heterogeneity in fees and a lot of variability in that tree in treatment and therefore, there are many different entry entry points for our drug can be used so.
The usage of our drug is across all aligned.
For a number of reasons, but in part because physicians have different treatment styles and they see the value proposition enrolled for our product differently, depending on how they prefer to treat the disease. So hope that hope that helps.
Now what percent of patients.
Eldon: So, what percent of our patients currently on Tavilis are post-typomimetic?
I will list.
Post the tip of embedded.
Yeah, I don't I don't think we have a reliable number for you we can check and possibly follow up at another time.
Eldon: Yeah, I don't think we have a reliable number for you. We could check and possibly follow up at another time.
Okay and then one other question.
Tony was recently launched based on how those people memetic.
Eldon: Okay, and then another question is, you know, DAPLI was recently launched. It's another type of mimetic. Do you, are you seeing any impact on tablets? I mean, although tablets are really too early, but do you, more importantly, do you expect that to have an impact on earlier use of tablets?
Do you.
Are you seeing any.
Impact on populism, who will go public it's really too early.
But do you have more importantly, the fact is that.
To have an impact on Oreo you silver toppling.
Raul R. Rodriguez: Let me try to answer that and then kick it over to Eldon. You know, our view has been and continues to be that the value proposition of Tavalis is driven by its mechanism of action, which is unique and different in the treatment of ITP by targeting the underlying disease mechanism. And that has resonated quite well with physicians and many other healthcare providers. And so that's the real focus of us. And for that reason, I think it continues unchanged, even with the recent launch of ibotrombin. Eldon, do you want to add some comments?
Well, let me, let me try to answer and then kick it over to Ellen.
You know I think you know our view has been and continues to be that the value proposition of top Elise is driven by its mechanism of action, which is unique and different and not in the treatment of eye to be addressing the underlying disease mechanism.
And that has resonated quite well with physicians and many other health care providers and so that's the real focus of us and for that I think it continues on unchanged even with the recent launch of by the Trump APAC Holden you want to add some comments.
Eldon: Yeah, I mean, it goes along with what I said before. I mean, we are being used, you know, across all lines, and I think there are physicians that are using our product before T-Pos and physicians that are using our product after them. So there are physicians that may choose to use a T-Po, and they can pick one of their choice, but we believe that we are well differentiated from that class, and we think there's a lot of rationale for using our product. When a T-Po has not resulted in a good clinical response, it makes more sense to use a product with a different mechanism of action like ours before moving on to yet another T So, again, of course, as you mentioned, it's way too early to see any impact there.
Yes, I mean, it goes along consistent with what I said before I mean, we are being used.
Across all lines.
And I think there are.
There are physicians that are using our products more t. posts.
And.
Physicians that are using our product.
After that so yes, there are physicians that.
Yes may choose to use the teco and they can pick one of their choice.
But we we believe that we are well differentiated from that class and we think theres a lot rationale for using our product.
When.
Tipo has not resulted in a good clinical response makes more sense to use products with different mechanism that action like ours.
Yes.
So again of course, he's actually it's way too early.
See any impact there.
Hi, Thanks, and the last question is well what do you want me to even EMEA a patient enrollment is going to be completion is they want to be expected them. Even next year and do you see the 24 week study so why Oh, why not data wholly owned impeded to present to wanting one thank you.
Eun Kyung Yang: All right, thanks. And the last question is, for autoimmune hemorrhidic anemia, patient enrollment is going to be, completion is going to be expected in the next year, and this is a 24-week study, so why not data earlier than mid-2021? Thank you.
Yes, Thank you and me.
Raul R. Rodriguez: Yeah, thank you, Eun Yang. So we initiated enrollment. We expect to have it enrolled mid-next year, and it is a rare disease, so keep in mind it is a challenging disease to enroll trial patients in this, and the fact that we're going to 22 countries is kind of a testament to that. And so we nonetheless plan on having completion of enrollment by mid-next year. Mid is broadly defined sometime in the summer, most likely. With that, it's a six-month study, and a couple more months of that after completion of the last patient and last visit, and so that could bring us into mid-2021.
So we initiated enrollment we expect to have it enrolled mid next year and it is a rare disease. So keep in mind. It is a challenging disease to enroll the trial patients in this and the fact that we're going to 22 countries. It kind of is testament to that and so we nonetheless plan on having completion of enrollment by mid next year mid is broadly defined sometime in the summer most likely.
With that it's a six month study and a couple of more months up that after completion of the last patient last visit and so that could bring us into mid 2021.
Hi, Thank you.
Allison Marie Bratzel: Thank you, Jude. Thank you. Our next question today is coming from Chris Raymond from Piper Jaffray. Your line is now live.
Thank you.
Thank you. Our next question today is coming from Chris Raymond from Piper Jaffrey. Your line is now live.
Dean L. Schorno: Hi, this is Allie Bratzel on for Chris today. Thanks for taking the question. Um, so we saw you guys took a nine and a half percent price increase on Tavalese effective late July. I think that's the second price increase this year after a smaller one in January. So just hoping you guys could talk about the strategy there.
Hi, this is <unk>.
On for Chris today, Thanks for taking the question.
So we saw you guys took a I think a 9.5% price increase on tower lease effective a weak July .
I think that the second price increase this year after a smaller one in January so just hoping you guys could talk about the strategy, there and what kind of not price tailwind, we should think about as we model 2019 and 2020.
Dean L. Schorno: And what kind of net price tailwind we should think about as we model 2019 and 2020. And then related to that, I think you mentioned that Q3 sequential growth trends are expected to moderate. Is that talking about sequential volume growth, or does that include any price impact? Thanks.
And then related to that I think you mentioned that Q3 sequential growth trends are expected to moderate that talking about sequential volume growth or does that include any any price impact. Thanks.
Dean L. Schorno: Okay. I will talk about our thoughts on pricing and our strategy there, and then I'll hand it over to Dean. Yeah, I mean, first off, our pricing is aligned with the category. In the ITP category, we've seen year-over-year price increases in the range of 10% to 14%, with price increases usually taking place early and mid-year. Our price adjustments this year are within that range for the industry norm and the category, the ITP category. You know, we believe that payer and patient access will be maintained prior to any pricing action. We ensure that any adjustment will maintain affordable access to Tavalease and continue to deliver good value for payers. So, you know, we thoroughly assess a number of things, working with physicians and payers, making sure there's minimal, if not no, impact on patient access competition as well, as well as consider overall just considering the costs that are required to make Tavalease available to patients. So that's it. Overall thoughts on the pricing, and do you have a question about margin and about future growth?
Yes, okay.
I will talk about the.
Our thoughts on the pricing and our strategy there and then I'll hand, it over to Dean.
Yeah, I mean first first off our pricing is in line with the category in the IP category we've seen.
Year over year price increases in the range of 10% to 14%.
Ah with price increases usually taking taken in early and mid year.
Our price adjustments this year are within that range for the industry norm and the category the category.
You know, we we believe that payer and patient access will be maintained prior to any pricing action, we ensure that.
Any adjustment will maintain affordable access to patients and.
The continued to deliver good value for payer. So yeah, we thoroughly assess a number of things working with physicians and payers.
Making sure there is minimal to no impact patient access.
Competition as well.
As well as overall just considering the costs that are required to make cavalese failure patient. So that's.
Overall thoughts on the pricing.
And you asked that question on margin about future growth, Yes, and then with respect to the gross to net adjustments during the quarter, we reported 18.5% gross to net adjustment and as you suggest we don't capture the entirety of these price increases as a result of the mix of government and commercial payers that said, we do think that gross to net.
Dean L. Schorno: And then, with respect to the growth-to-net adjustment, during the quarter, we reported an 18.5% growth-to-net adjustment. And, as you suggest, we don't capture the entirety of these price increases as a result of the mix of government and commercial payers.
Rate will remain in the 19% area three through the rest of the year.
Dean L. Schorno: That said, we do think the growth-to-net rate will remain in the 19% area through the rest of the year. With respect to the comment on moderation of the sequential growth rate, that was intended to be around net revenues. I would remind everyone that we're not intending to give guidance, and therefore it is a general comment.
With respect to.
The comment on a moderation of the sequential growth rate that was intended to be around net revenues.
I would remind everyone that we're not intending to give guidance and therefore it is that it is a general comment we are excited about the 26% sequential growth in Q2 and as I said in my comments that that's coming off of a 10% growth in Q1 that has the reimbursement headwinds. So as we think about Q3.
Dean L. Schorno: We are excited about the 26% sequential growth in Q2. And as I said in the comments, that's coming off of the 10% growth in Q1 that had the reimbursement headwinds. So as we think about Q3, we believe that we'll continue to have robust growth, which will be a combination of both model power as well as pricing.
We believe it will continue to have you have to have robust growth.
Which will be a combination of both a bottle count as well as price increase.
Allison Marie Bratzel: Got it. Thank you.
Got it thank you.
Yigal Dov Nochomovitz: Thank you, Ellie.
Thank you Alex.
Yigal Dov Nochomovitz: Thank you. Our next question today is coming from Yigal Nochomovitz from Citigroup. Your line is now live.
Thank you. Our next question today is coming from New York.
No some of it's from Citigroup. Your line is now what.
Eldon: Hi. Thanks for taking the questions. Hi, Raul and team. I think in previous quarters you had given the statistics on physicians with multiple patients. I didn't see that for this quarter. Could you provide any color there? Thanks.
Yeah, Hi, thanks for taking the questions.
Hi, Roland team I think you in previous quarters, you would given the statistic on the physicians with multiple patients I didnt see that for this quarter could you provide any color there. Thanks.
Sure.
Eldon: Yeah, I'll take that one, Eldon again. So we're seeing a positive trend of repeat prescribers, I think that's what you're referring to, in the 20% range. We do expect this to gradually increase over the long run as more physicians become familiar with Tavalease and its value proposition and see a benefit, a clinical benefit, for the patient.
Yes, I'll take that one element [laughter]. So we're seeing a positive trend of repeat prescribers I think that's what you're referring to in the 20% range.
We do expect this to gradually increase over the long run as more physicians become familiar with top beliefs and its value proposition and see a benefit.
Clinical benefit for the patient.
Okay. So it's in the 20% range got it and then held and I think he mentioned that in your comments that you're educating yourself on the market and I was just curious what is your confirm from your market research in your in the in the launch that has been a consistent with your market research and what has been the sort of biggest misconception. Once you went went live with the launch and how have those learnings shipped your overall strategy.
Eldon: Okay, so it's in the 20% range. Got it.
Eldon: And then, Eldon, I think you mentioned in your comments that you're educating yourselves on the market. And I was just curious, what have you confirmed from your market research during the launch that has been consistent with your market research? And what has been the sort of biggest misconception once you went live with the launch? And how have those learnings shaped your overall strategy?
Yeah, I think initially when we did the market research.
Eldon: Yeah, I think initially, when we did the market research, I think some of the unmet needs in the market were a little bit understated. Often, when you're doing market research well prior to launch, and physicians aren't as aware of what's coming, they're thinking about the unmet needs in the framework of what they have. And they've accepted things about products that may not be optimal or that they'd like to see change. And so I think that that was a little bit of a surprise on the positive side. I think also that one of the things that we did get right was our positioning of the product. I don't think I would change that, going back and doing it again.
I think some of the unmet need in the market, we're a little bit understated.
Often when you're doing market research well prior to launch and traditions are as aware of whats coming they are thinking about the unmet need in the framework of what they have and they have accepted Ah things about products that may not be awful or they'd like to see change and so I think that.
That was a little bit of a surprise on the positive side I think also that one of the things that we we didn't get it right. I think is our positioning of the product I don't think I would change that.
Going back and doing it again I think we heard about the unmet need Oh, we also heard about that as I alluded to just now.
Eldon: I think we heard about the unmet need, but we also heard about that, as I sort of alluded to just now. But we heard about the unmet need relative to the disease, and we heard something about platelet production as a pathophysiology, but we heard a great deal about platelet destruction. That remains to be something that's important to physicians, and we'd like to address that underlying pathophysiology, and I think that's been validated. Some of the things that I was alluding to earlier about some of the things that doctors had accepted were things like the lack of a food effect for our products. I think that it was something that was perceived well. I think that we haven't received as much concern as, you know, about the AE profile. I think that's been, the product profile has been well accepted by the physician community. So those are some things that are sort of positive and as expected. I hope that answers your question. But it's something, you know, we continue to monitor, of course, as I mentioned, through our advisory boards and our ongoing market research.
But we heard about.
The unmet need relative to the disease, and we heard something about platelet production.
The pathophysiology, we heard a great deal about platelet destruction that remains to be something that's important positions I would like to under to address that underlying pathophysiology I think that's been validated.
Some of the things that I was alluding to earlier about some of the things that doctors had accepted work.
Things like the.
The.
A lack of a food effect for our product to think that was something has been perceived well.
I think that we haven't received as much concern.
As you know about the profile I think thats been the product profile has been well accepted by the physician.
Community. So those are some things that are sort of on the on the positive and as expected I hope that answers. Your question, but it's something we continue to monitor of course as I mentioned.
In our advisory boards and our ongoing market research.
Okay. Thanks, and then just a question on the quarter, obviously, good numbers. So a rule and team I just want to understand if this is more of a reflection of just the relatively weaker comp Q1 given the reimbursement headwinds that you alluded to or is there something that's changed are you doing something different on the commercial side that is what is ramping things better or just to check, especially since the refill rate is the same just wondered if you could comment a little more on on that.
Yigal Dov Nochomovitz: Okay, thanks. And then just a question on the quarter. Obviously, good numbers. So, Raul and team, I just want to understand if this is more of a reflection of just the relatively weaker comp in 1Q, given the reimbursement headwinds that you alluded to, or is there something that's changed? Are you doing something different on the commercial side that is making things better? Because especially since the refill rate is the same, I just wondered if you could comment a little more on that.
Raul R. Rodriguez: Yeah, I think this is, I'll let my colleagues also comment, I think it's a mix of those things. I think clearly there was some benefit that we derived from a muted Q1 that helped this quarter out a bit. But in addition to that, I think the story is resonating, and doctors are trying the product, trying it in more patients. Patients are staying on the product longer, especially as we tap into additional doctors. We hired additional reps early in the year, and they're clearly showing a benefit in terms of talking to new doctors. So really, it's really driving and executing on the strategy overall that I think is the underlying result that causes this substantial increase.
Yeah I think this is I'll, let my colleagues also comment I think it's a mix of those things I think clearly there was some some some benefit that we derive from a a muted Q1 that helped this quarter out a bit but in addition to that I think the story is resonating and doctors are trying the product.
Brian you did more patients patients are staying on the product longer, especially as we tap into additional doctors, we hired additional reps out early in the year and there are clearly showing a benefit.
In terms of Oh talking to new doctors are really it today, it's really driving and executing on the strategy overall that I think is the underlying underlying as a result of the causes this substantial increase.
Yigal Dov Nochomovitz: Got it. All right. Thank you very much.
Got it all right. Thank you very much.
Thank you. Our next question today is coming from Joe Pantginis from each C. Wainwright. Your line is now live.
Joseph Pantginis: Thank you. Our next question today is coming from Joel Pantginis from H.C. Wainwright. Your line is now live.
Hey, guys. Good afternoon, I'm wanted ask a question about your pace your physician experience when you talked about the ER patient that had modest benefit then went onto a tight trade stayed on therapy. So I wanted to go off of that and say do you have any evidence regarding or do you see patients that have not necessarily stayed on therapy long enough that you believe could have received benefit and if so how are you addressing that.
Eldon: Hey guys, good afternoon. I wanted to ask a question about your physician experience when you talked about the patient that had modest benefit, then went on to, you know, titrate, and stayed on therapy. So I wanted to go off of that and say, do you have any evidence regarding, or do you see patients that have not necessarily stayed on therapy long enough that you believe could have received benefit? And if so, how are you addressing that?
Oh, you mean I suppose you were asking for commercial.
Joseph Pantginis: What do you mean? I thought you were asking for a commercial experience.
Eldon: Joe, hi, this is Eldon. So I can tell you that one of the things that we emphasize at launch is the rapid response. And so sometimes what we saw was some physicians discontinuing a little prematurely and not giving it the full 12 weeks and also not escalating. So these are things that we've educated our patients about as well, and I think that's helped with that. And so we did see in our clinical studies, and it was in our package insert, that some patients took a little bit longer. So I think messaging with that general information, in addition to just getting comfortable with the drug, has helped in that area.
Okay. So.
Hi, Selman, so I can tell you that.
One of the things that we message it launches launches a rapid response and so.
Sometimes what we saw is some physicians discontinuing a little prematurely in not giving it for 12 weeks and also not escalating. So these are things that weve.
Educated too as well and I think Thats helped.
With that.
And so with that we did see in our in our clinical studies and that was in our package insert that some patients took a little bit longer. So I think messaging that is general.
In addition to just getting comfortable with the drug.
Has helped.
It's in that area.
Okay and like tax ask a more macro question. If you don't mind I've been discussing this point with.
Joseph Pantginis: Okay. And I'd like to ask a more macro question, if you don't mind. I've been discussing this point with multiple ITP players and physicians. When you look at the upcoming finalized guidance for ITP discussed at ASH-18, how do you feel these guidelines could benefit Tavilis? But even more importantly, do you think these guidelines will help in general? Because even though the indication is so heterogeneous.
Multiple ATP players and physicians when you look at the upcoming finalized guidance for I T. P discuss data discussed coming out about 18, how do you feel these guidelines could benefit tabah lease, but even more importantly, do you think these guidelines will help in general because even though the indication is so heterogeneous.
Yeah, I'll comment and ask Anne Marie to comment as well no because the guidelines currently existing are really quite outdated and they precede the approval and introduction of uptake of the people age and so it's a it's a good to have the guidelines being up didn't particularly were interested in the international working group guidelines is also appealing in addition to the ash guidelines being updated and so we're happy to be contributors to that and I'll, let Ann Marie maybe talk a little bit more about those.
Raul R. Rodriguez: I'll comment and ask Anne-Marie to comment as well. You know, the guidelines currently existing are really quite outdated, and they precede the approval and introduction of the TIPO agent. So it's good to have the guidelines being updated. In particular, we're interested in the International Working Group guidelines being updated, in addition to the ASH guidelines being updated. And so we're happy to be contributors to that, and I'll let Anne-Marie maybe talk a little bit more about that.
Anne-Marie: Yeah, we know that phosphamidinib is going to be mentioned in the guidelines. What we don't know yet exactly will be the position of phosphamidinib, and so we'll be eager to see how it's positioned in the guidelines.
Yes, we know that somebody is going to be mentioned in the guidelines would we don't know yet exactly is going to be the position of softening in it and it will be eager to see how its position in the guideline.
Understood. Okay. Thanks, guys.
Joseph Pantginis: Understood. Okay, thanks guys.
Thank you as a reminder, that star one to be placed into question Hugh.
Kristen Brianne Kluska: Thank you. As a reminder, that's star number one to be placed into question Q. Our next question today is coming from Kristen Kluska from Cantor Fitzgerald. Your line is now live.
Our next question today is coming from Chris inclusive from Cantor Fitzgerald. Your line is now live.
Eldon: Hi, good afternoon, and thank you for taking my question. Could you talk about the breakdown of specific types of physicians who are prescribing Tavalese? And of these, how many do you expect might also have some experience in treating AIHA?
Hi, good afternoon, and thank you for taking my question could you talk about the breakdown of specific types of physicians, who are prescribing have lease and of this how many do you expect [laughter] might also have some experience in treating a high ha.
Anne-Marie: Sure, I will take a stab at that and anyone else, if you want to chime in. And when you say different types, I'll interpret that in the best way that I can, but feel free to follow up. We look at that, and overall, we are seeing very broad usage of the product. We've actually looked as carefully as we can based on the data sets that we have to see if there's any kind of a niche or any particular segment of physicians, and we're just not seeing that. We're seeing, as I said, usage across lines. There's a lot of experimentation with the drug. I think that also, when you look at whether it's academic or community-based, we're being used in both settings.
Sure I will take a stab at that and anyone else.
Yes, you want to chime in.
And when you say different types, all interpret that as in the best way that I that I can but feel free to follow up on we look at that and overall.
We are seeing very broad usage of the product we've actually looked as carefully as we can based on the data sets that we have to see if there's any kind of a niche or any particular segment of physicians. When you start seeing that we're seeing as I said usage across lines usage.
Before reduction after a toxin before depots after tea posts. So there's a lot of experimentation with the drug.
I think that also when you look at whether its academic or community based or were being used in both settings.
Anne-Marie: Additionally, we're looking at the deciles, if you will, of prescribing by volume. And so, sometimes the higher deciles of physicians, the ones that prescribe the highest volumes, can be the most difficult to penetrate. But we're not seeing that either here. We're seeing usage across different deciles as well. And I think we're doing a lot there with our customer-facing team. We've added five more reps to 35 reps. We're engaging with our field-based reimbursement team, and, of course, as a supportive effort for education with the MSLs. So, the combination of all of these things. And then I also did not mention our field-based marketing team. So, we've been gradually adding more resources there for our customer-facing team, and they're getting better and better at engaging. It just takes time.
Additionally, we are looking at the.
Debt tiles, if you will or that of the prescribing bye.
Oh volume and so sometimes the higher deciles of physicians the ones the prescribed the highest volumes can be the most difficult to penetrate but we're not seeing that either are seeing usage across different desktops as well.
Yes, and that's I think we're doing a lot better with our customer facing team. We've added five more reps 35 reps.
We're engaging with.
Our.
Phil based reimbursement team and as well of course as a part of that for education with the MSL. So the combination of all of these things and then I also did not mention our field based marketing team. So weve been gradually adding more resources there to our customer facing team and they are getting better and better at engaging just takes time so.
Kristen Brianne Kluska: And as to the second question, which is whether physicians treating patients with ITP are also likely to see patients with autoimmune hemolytic anemia, the answer is clearly yes. This is the same specialty of hematology, even for hemato-oncologists. They would likely see those two types of patients. However, autoimmune hemolytic anemia, as we have mentioned, is a rarer disease than ITP, so they would see fewer such patients
And as to the second question, which is whether patients treating physicians treating patients with NTP also likely to see patients we do to immune hemolytic anemia. The answer is clearly yes. This is the same.
Specialty of hematology, even for hematology colleges, they would likely see on those two types of patients. However.
Oh, two immune hemolytic anemia as was mentioned is a lever disease, then he's ITD be so they would see fewer such patients.
Kristen Brianne Kluska: Great, thank you.
Great. Thank you very much.
Raul R. Rodriguez: Great, thank you very much.
Unknown Executive: Thank you, Kristen. Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to Raul for any further closing comments.
Thank you Chris.
Thank you. We appreciate of our question and answer session I like to turn the floor back over to roll for any further or closing comments.
Raul R. Rodriguez: Thank you, and thank you for your questions. You know, it's been a year since we launched this product, and I can honestly say that we're delighted with how the launch has gone and how this year has progressed. I think, you know, just the numbers speak for themselves, $32 million in net revenue, but most importantly, over a thousand patients haven't tried Tavalese, and many of them, nearly half, are showing a benefit in month four of refills. That's a fantastic outcome, I think, for the first year of the product, and I think we're equally optimistic about what the next year is going to bring. I was at the PDSA, the Platelet Disorder Support Association, meeting about 10 days ago. Every year they have an excellent meeting that is very patient-focused.
Thank you and thank you for your questions you know it's been a year since we launched this product in and I can honestly say that we're delighted with how the launch is gone and how this year has progressed I think.
Just the numbers speak for themselves 32 million in net revenue, but most importantly over a thousand patients haven't tried tommy's and many of them nearly half are showing a benefit in month four refills. That's fantastic out outcome I think for the first year of the product then and I think were equally optimistic about what the next year is going to bring.
I was at the PD as say the plate this sort of support Association meeting about 10 days ago every year. They have been excellent meeting that is very patient focused and it's one of my favorite meetings of the year and this year was no different.
Raul R. Rodriguez: And it's one of my favorite meetings of the year, and this year was no different. Here you get to learn the patient's struggle with this disease, and I have to say, more than in previous years, it was really a session that brought tears to many people in the audience because of how difficult this disease is and what a toll it takes on not only the patients but also their families. And so it was great to be able to say that we're bringing a new product to these patients with a different mechanism that hopefully will help some of them. And we're so excited about being able to continue to do that in our second year on the market. So thank you, and thank you for your support. I look forward to keeping you updated.
Here you get to learn the patient the patient struggled with this disease and I have to say more than even prior years. It was really a session that brought tears to many people in the audience on how difficult to this disease is and what a toll that takes on the patients but also their families and so it was a it was great to be able to say that we are bringing a new product to these patients with a different mechanism that hopefully will will help some of them and we're we're so excited about being able to continue to do that in our second year of being on the market. So thank you and thank you for your support and look forward to keeping you updated.
Unknown Executive: Thank you. That does conclude today's teleconference. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.
Thank you that does conclude today's teleconference. You may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.