The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Thanks, Chris, for the presentation. And as a reminder, if you want to ask questions, please you can submit those questions using the big blue
button, and I can be able to get back to Chris and Jo and talk.
So maybe as a first question, focusing on the IV KORSUVA, what has been the progress for launch preparations? And ultimately, when should we
expect to see revenue from KORSUVA injections flowing through Cara's financials?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: And then as you talk with these prescribers, what's the level of awareness that they are giving you back in terms of feedback about the (inaudible)
pruritus? And how would they characterize the proportion of patients who will be eligible for KORSUVA injection once it comes online?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: We actually have a question on the portal. Given the sale of Vifor to Australian pharma, how can you -- how would you characterize your engagement
with you and whether it has changed or it remains the same as you go forward?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: So you've managed to get this TDAPA designation, but now we are working with Vifor to determine pricing. So maybe give us an understanding
of what are the considerations that go into determining the price between you and Vifor for the injection.
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Okay. You have mentioned -- so following the granting of the TDAPA by CMS that they have expressed interest in continuing working with you
even past the 2-year period. So how are you thinking about potentially extending the TDAPA? And maybe you can elaborate for us what type of
support CMS can offer to do to be able to accomplish that?
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JANUARY 10, 2022 / 4:15PM, CARA.OQ - Cara Therapeutics Inc at JPMorgan Healthcare Conference (Virtual)
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: I have to ask this. Given that you're launching in 4Q, how should we think about the shape of the launch trajectory? And maybe how do you think
about the peak potential opportunity for IV -- KORSUVA injection?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Should we expect any guidance on revenue in 2022?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Okay. And then this morning, you released a press release regarding the positive result from Japanese study of IV -- of KORSUVA injection in
hemodialysis patients. Maybe can you briefly comment on that and also give us an understanding of the revenue opportunity there is for you,
especially considering that there's already an approved product in Japan for that indication?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Maybe shifting to oral KORSUVA. You've expressed in the prepared remarks your excitement to move to the Phase III. Maybe can you give
us what the data points that led you to that excitement and as you advance the product into Phase III?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Maybe focusing on the atopic dermatitis setting, with an atopic dermatitis, which patients actually will be included in as you go forward? Do you
plan to include all of them consider if they have the moderate to severe pruritus? Or are you going to select from the mild to moderate to severe
atopic dermatitis patients?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Okay. And in terms of the nondialysis CKD patients, I believe, you previously mentioned you were planning to run 2 trials. So just when we think
about it, ultimately, when you read out the trial, is one positive trial enough for registration? Or will you have to hit both of them? And also, will
you be able to run those trials in parallel or in a staggered fashion? And I understand you haven't finalized the design, but if you could provide us
some highlights.
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Great. And then as we shift to the earlier-stage pipeline, maybe can you give us an idea why the data coming for the PBC trial shifted from
first half to second half? Is it due to COVID? And should we anticipate any more shifts as we go forward due to impact from COVID?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: And then you have data in 2Q coming from the notalgia paresthetica program. What would be concerned a win there?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Okay. And I guess, just big picture, can you walk us through the regulatory pathway and how potentially single approvals in each indication could
translate to a broad antipruritic label for oral KORSUVA?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Maybe to wrap up with one last question to Tom. The cash guidance runway through 2023, what are some of the considerations in terms of what
it will cover up to that point?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Great. Again, thank you very much, Chris, Tom, Jo. And with that, we should wrap it up.
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JANUARY 10, 2022 / 4:15PM, CARA.OQ - Cara Therapeutics Inc at JPMorgan Healthcare Conference (Virtual)
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