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Concert Pharmaceuticals, inc (CNCE) Q2 2021 Earnings Call Transcript

By Motley Fool Transcribers – Aug 5, 2021 at 4:30PM

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CNCE earnings call for the period ending June 30, 2021.

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Concert Pharmaceuticals, inc (CNCE -5.04%)
Q2 2021 Earnings Call
Aug 5, 2021, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day and thank you for standing by, and welcome to the Concert Pharmaceuticals Second Quarter 2021 Financial Results Conference Call. [Operator Instructions] After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Justine Koenigsberg. Please go ahead.

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Justine E. Koenigsberg -- Senior Vice President, Corporate Communications and Investor Relations

Good morning and welcome to Concert Pharmaceuticals' second quarter 2020 investor update. Like last quarter our prepared comments today will be brief, so we can jump right into the Q&A portion of the call. Roger Tung, our CEO will provide the CTP-543 key highlights; and then Marc Becker, our CFO will walk you through the second quarter financials. We will then be joined by Nancy Stuart, our Chief Operating Officer; and Jim Cassella, our Chief Development Officer for the Q&A portion of the call.

As a reminder, today's discussion will include forward-looking statements about our future expectations, plans and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected. A description of these risks can be found in our most recent 10-K filed with the SEC. Any forward-looking statements speak only as of today's date and we assume no obligation to update any forward-looking statements made on today's call.

With that, I would now like to turn the call over to Roger.

Roger D. Tung -- Co-Founder, President and Chief Executive Officer

Thank you, Justine. This past quarter we continue to execute on the pivotal clinical development of CTP-543 for Alopecia Areata. We presented additional promising data from our long-term open label study of CTP-543 and we strengthened our balance sheet. Importantly, we remain on track to file our CTP-543 NDA in the early part of 2023.

In the second quarter, we initiated THRIVE-AA2, our second Phase 3 trial for CTP 543. As a reminder, this study has a similar design to the THRIVE-AA1 trial. Between the two THRIVE-AA studies, we expect to enroll more than 1,000 individuals with moderate to severe Alopecia Areata. These Phase 3 trials, our long-term extension studies and other ongoing and completed trials will provide us with a sizable safety database, including a significant number of patients receiving treatment for longer than one year to support our NDA. We continue to engage with treatment community about CTP-543 and to be a vocal advocate for the needed progress in the treatment of Alopecia Areata.

For example, last month we had the opportunity to present findings from the ongoing CTP-543 open label extension study at second JAK Inhibitors Drug Development Summit. Currently over 100 patients have been dosed with CTP-543 for at least a year and a half. Importantly, a high percentage of eligible patients have elected to continue to participate in the extension study. Treatment with CTP-543 in the study continues to be generally well tolerated with adverse events consistent with those recorded in the Phase 2 studies.

Importantly, SALT scores assessing hair regrowth were maintained or improved in the vast majority of Alopecia Areata patients, who continued in the study. CTP-543 has the potential to be a best-in-class treatment for Alopecia Areata and remains the top priority for our business. Our team is focused on expeditiously executing the Phase 3 THRIVE-AA clinical program and is deep into planning for the regulatory pathway to NDA. There is an enormous need for an FDA approved treatment for Alopecia Areata, and we're proud that concert was one of the first in the industry to take notice of this important disease by advancing CTP-543.

Let me pause here and turn the call over to Mark.

Marc Becker -- Chief Financial Officer

Thank you, Roger. As I review our second quarter 2021 financial results, please reference the financial tables found in today's press release. Revenue was $32 million for the second quarter of 2021, due to the monetization of outstanding milestones under our 2017 asset sale to Vertex. We were happy to bring in this additional non-dilutive capital and strengthen our balance sheet as we continue to advance CTP-543 through its Phase 3 program.

Research and development expenses were $20.2 million during the second quarter of '21, compared to $14.8 million during the same period in 2020. The Q2 '21 increase was primarily related to the ongoing CTP-543 Phase 3 clinical program.

General and administrative expenses were $5.6 million during Q2 '21, compared to $4.7 million for the same period in 2020. The Q2 '21 increase was primarily attributable to higher external professional service expenses and non-cash stock-based compensation.

Our net income for Q2 '21 was $5.4 million or $0.16 per share, compared to a net loss of $13 million or $0.41 per share during the same period in 2020. We ended the second quarter of 2021 with $122.4 million in cash and cash equivalents. Under our current operating plan, we expect our cash and cash equivalents to fund the Company into the second quarter of 2022.

This concludes our prepared remarks and we would be happy to address any questions.

Questions and Answers:

Operator

And thank you. [Operator Instructions] And our first question comes from Jason Butler from JMP Securities. Your line is now open.

Devin Ryan -- JMP Securities -- Analyst

Hi, it's Ryan for Jason. Thanks for taking our questions. Just a couple of questions, one on the THRIVE-AA1 and 2 trials, it sounds like enrollment is going fine, the trials [Indecipherable] any feedback from investigators or the patients that you can share. Just characterize what they're seeing in the trial? And then just wondering if you have any comments on the recent results from Pfizer with their drug Ritlecitinib Phase 2b/3 results that were recently announced? Thanks.

Roger D. Tung -- Co-Founder, President and Chief Executive Officer

Thanks for the question. Jim, could you start off on that and I may chime in afterwards.

James V. Cassella -- Chief Development Officer

Sure. Yes, so the -- as you know, the trials are ongoing. So we really can't make any comments on anything regarding the details of the trial. But the trial -- both trials continue to progress nicely with enrollment and we are on track as we projected with our expected completion dates in the early next year for THRIVE-AA1 and second half for THRIVE-AA2. As far as the -- go ahead, Roger.

Roger D. Tung -- Co-Founder, President and Chief Executive Officer

No. Go on.

James V. Cassella -- Chief Development Officer

Okay. I think, you know, there wasn't really any data to speak of in the press release for Ritlecitinib. So it's really hard to determine what they're seeing in that trial.

Roger D. Tung -- Co-Founder, President and Chief Executive Officer

Yes, I agree with that.

Devin Ryan -- JMP Securities -- Analyst

Fair enough. Thank you.

Operator

Thank you. And our next question comes from Maury Raycroft from Jefferies. Your line is now open.

Unidentified Participant

Good morning, everyone. This is [Indecipherable] on for Maury. Thank you for taking our questions. Just to follow-up on the two Phase 3s, since the focus is there. Are you potentially thinking of any innovations to accelerate enrollment given the enthusiasm in the study.

Roger D. Tung -- Co-Founder, President and Chief Executive Officer

Jim?

James V. Cassella -- Chief Development Officer

I mean, yes, so we have -- we've implemented all the things that we need to do to keep enrollment going in the THRIVE program. So I think we are really pulling out all stops as we have been from the very beginning to make sure that we have patients enrolled in both studies on our timeline. I think we're tracking both trials toward the completion dates that we projected.

Unidentified Participant

Okay, great. Thank you for taking [Technical Issues].

Roger D. Tung -- Co-Founder, President and Chief Executive Officer

Sure.

Operator

Thank you. [Operator Instructions] And our next question comes from Difei Yang from Mizuho. Your line is now open.

Alexandre Bouilloux -- Mizuho Securities -- Analyst

Hi, good morning. This is Alex [Phonetic] on for Difei. Thanks for taking the question. So you recently presented some long-term data from CTP-543, where you showed from a safety standpoint stable hematology parameters over time. I was wondering if you could help contextualize this data relative to what we know from experience with other JAK Inhibitors around hematology parameters? And then just how do you see the overall safety profile 543 relative to other JAK Inhibitors?

James V. Cassella -- Chief Development Officer

Sure. Thanks, Alex. Great question, because we know that JAK Inhibitors have a known pharmacology profile. I think what we've been seeing and what we reported in the JAK conference recently is that the key parameters that we continue to monitor in the hematology side of things neutrophils, platelets, etc., are all very stable as we look at longer term dosing. I think this is a very important finding to be reported, but also for us to be continuing to look at, because I believe we have the longest term data out there for JAK Inhibitor coming from controlled trial.

So I think the fact that we're seeing stability of our hematology responses as we now go out in subjects over a year of, you know, continuous dosing is very good sign for this product. And I think it's going to be very important in our submission package as we have all these long-term studies -- this long-term data that we'll be able to put in there. So I think the profile, we're seeing is not inconsistent with what was expected for JAK inhibition. But I think the important thing is that the data shows that we have good stability of these parameters as we continue to dose for a long period of time.

Roger D. Tung -- Co-Founder, President and Chief Executive Officer

Hi, this is Roger. I just want to add in that. I agree with everything that Jim said, this is really with respect to Alopecia Areata patients, JAK inhibition of course has been studied in other disease states for substantial periods of time in clinical trials, but we know that the pharmacology of JAK Inhibitors and their effects on patients, both therapeutically and adverse effects are really associated with the underlying disease state of the patients. So we have studied CTP-543 in Alopecia Areata patients and reported, as Jim indicated, what we believe is the longest-term data in that patient population in our -- so far very pleased with what we see in terms of the safety versus efficacy profile.

Operator

And thank you. And I'm showing no further questions. I would now like to turn the call back to Justine Koenigsberg for closing remarks.

Justine E. Koenigsberg -- Senior Vice President, Corporate Communications and Investor Relations

We'd like to thank everyone for joining us this morning and we look forward to continuing to keep you updated on our progress. In the meantime for a list of upcoming investor conferences, please visit the events page within the Investor section of our website. This concludes today's call. Thank you.

Operator

[Operator Closing Remarks]

Duration: 12 minutes

Call participants:

Justine E. Koenigsberg -- Senior Vice President, Corporate Communications and Investor Relations

Roger D. Tung -- Co-Founder, President and Chief Executive Officer

Marc Becker -- Chief Financial Officer

James V. Cassella -- Chief Development Officer

Devin Ryan -- JMP Securities -- Analyst

Unidentified Participant

Alexandre Bouilloux -- Mizuho Securities -- Analyst

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