Neurocrine Biosciences, Inc. (NASDAQ:NBIX) Q3 2023 Earnings Call Transcript
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) Q3 2023 Earnings Call Transcript October 31, 2023
Operator: Good day, everyone. And welcome to the Neurocrine Biosciences Reports third quarter results. At this time, all participants are in a listen-only mode. Later you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note this call is being recorded and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Todd Tushla, Vice President of Investor Relations. Please go ahead.
Todd Tushla: Good morning. Happy Halloween and thanks for joining Neurocrine’s third quarter 2023 earnings call. I’m pleased to be joined by Kevin Gorman, our Chief Executive Officer; Matt Abernethy, our Chief Financial Officer; Eiry Roberts, our Chief Medical Officer; Eric Benevich, our Chief Commercial Officer; and Kyle Gano, our Chief Business Development and Strategy Officer. During today’s call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. After prepared remarks, we’re going to try and get to all of your questions. So, Kevin, take it away.
Kevin Gorman: Thank you, Todd, and good morning, everyone. It’s been a very, very good quarter. I’m not going to go into really any detail. I think everyone else who’s going to be talking on the call will, and as always, we just want to spend as much time with your questions as possible. What I will say is that, it’s rare that you get to announce so much progress from a clinical standpoint with CAH from a regularly -- regulatory standpoint with the Huntington’s approval and then the outstanding work by our commercial and field medical units in bringing INGREZZA to so many patients and to having the success we’re having there. That’s all I really want to start out with today. So much to talk about, so what I’d like to do is I’d like to turn it over to Matt right now. Thank you.
Matt Abernethy: Good morning. Between our positive Phase III results in CAH, record INGREZZA sales and solid cash flow generation, we had an incredible quarter. During the quarter, INGREZZA sales were $486 million, reflecting 29% year-over-year growth. The INGREZZA commercial, marketing and medical teams are doing an excellent job continuing to build and develop the tardive dyskinesia market. With INGREZZA net sales through Q3 at approximately $1.34 billion, we’re increasing our guidance range to $1.82 billion to $1.84 billion. Our financial profile strengthened in Q3, resulting in non-GAAP diluted earnings per share of $1.54 and over $1.5 billion in cash at quarter end. We continue to prioritize our capital towards growing INGREZZA in both expanding and advancing our pipeline.
As we mentioned during a recent call, we’ll be hosting an Analyst Day on December 5th. The agenda will be focused on our R&D strategy and include preclinical and clinical pipeline updates. We’ll also feature a panel discussion on congenital adrenal hyperplasia centered on addressing the challenges of current therapies for patients, caregivers and clinicians. We look forward to seeing all of you in New York. With this, I will now hand the call over to Eric Benevich, our Chief Commercial Officer. Eric?
Eric Benevich: Thanks, Matt. Q3 2023 was a great quarter for INGREZZA with both strong continued growth from our TD franchise and the initial rollout of the new HD Chorea indication, which I’ll discuss later. It’s been six years since our initial launch and I continue to be impressed with our team’s ability to help improve diagnosis and treatment rates for patients living with tardive dyskinesia. And our just announced increase to the full year guidance range reflects our confidence in continued strong growth. In the half dozen years since the launch, we’ve grown the diagnosis rate of TD from low single digits to around 35% of the prevalent population. While this is great progress, it also means that about two-thirds of the roughly 600,000 patients who suffer from TD have not yet been diagnosed, much less treated with a VMAT2 inhibitors like INGREZZA.
Net-net, we clearly have much work to do to help more TD patients get a diagnosis for their uncontrollable movements and have the option to be treated. In August, we were excited by the FDA approval of the new indication for the treatment of adults with Chorea associated with Huntington’s disease. Now we have an opportunity to help yet another patient community in need. The many thousands of those HD patients who today continue to suffer with untreated Chorea. With approval occurring just a few short months ago, we are in the early stages of introducing INGREZZA to the HD community. But I can say that early feedback has been encouraging. Just as in TD, INGREZZA offers meaningful and differentiated benefits for HD Chorea patients, including high selectivity for VMAT2, rapid and sustained efficacy, good tolerability, simple one capsule, once daily dosing and comprehensive support programs.
These are the reasons why INGREZZA is the most prescribed VMAT2 inhibitor and I’m confident that these attributes will translate well to the HD Chorea community. I’d like to close by congratulating our clinical development colleagues on the recent positive Phase III results for crinecerfont in both pediatric and adult congenital adrenal hyperplasia patients. The trial results were outstanding. I believe crinecerfont, if approved, has the potential to be a paradigm changing treatment option. Today, the standard-of-care utilizing supraphysiologic doses of glucocorticoids to suppress excess androgen production creates unwanted side effects and long-term complications. Patients are faced with dealing with the undesirable effects of excess androgen production or the undesirable effects of chronic treatment with high dose GCs. That’s a terrible tradeoff and we believe crinecerfont can establish a new standard-of-care.
From a commercial perspective, we’ll be diligently working to demonstrate the high value we expect crinecerfont to bring to the CH community. While it’s premature to speculate on price, early discussions with payers have been productive in recognizing the benefits that lowering excess androgens and/or reducing GC exposure could bring to patients living with this inherited orphan genetic disorder. So, at this time, I’ll hand the call over to my colleague, Dr. Eiry Roberts, our Chief Medical Officer.
Eiry Roberts: Thank you and good morning. During our earnings call back in February, I noted that 2023 promised to be an important year for the Neurocrine pipeline. Today, I could not be more pleased to discuss how we are fulfilling that promise. Q3 featured several significant pipeline milestones, which I will address further. Beginning with our on-time FDA approval of INGREZZA for the treatment of Chorea associated with Huntington’s disease. As Eric noted, the vast majority of patients with HD Chorea are currently untreated. Given INGREZZA’s attractive product profile and differentiated attributes, I’m confident that Eric and his team will be able to change that. To further differentiate INGREZZA, we’ve developed the INGREZZA sprinkles formulation, which the FDA accepted as a new drug application last month.
This potential new formulation could serve as a preferred alternative administration option for many of the tardive dyskinesia and Huntington’s disease patients who have trouble swallowing or simply prefer not to take a whole capsule. Turning to crinecerfont, I believe everyone is familiar with the outstanding topline statistically significant and clinically meaningful results from our adult and pediatric Phase III CAHtalyst studies. There is much more data to share with you that will become available over time, either in peer reviewed journal articles or scientific conferences. During our KOL call earlier this month, Dr. Rich Auchus adeptly summarized the hope that the burden of congenital adrenal hyperplasia can someday be alleviated by a simple block and replace strategy.
With the androgen excess caused by CAH managed by treatment with crinecerfont, thus providing clinicians with significantly more flexibility in treating the cortisol deficiency caused by CAH with lower levels of exogenous steroids. In our upcoming Analyst Day, as Matt mentioned, we are planning a panel discussion focused on the current burden of disease in CAH and how crinecerfont, if approved, could potentially significantly ease that burden for patients, caregivers and clinicians. On the muscarinic front, our lead asset, NBI-568, continues to enroll very well in the Phase II study in schizophrenia. In addition, the clinical trial application for NBI-570, our dual M1 / M4 agonist was accepted and that program is currently dosing in a Phase I study.
These two compounds represent just the first of several muscarinic compounds that we will be advancing into the clinic over the coming months. Finally, we remain on track to deliver topline data for both NBI-352 in focal onset seizure and for NBI-846 in anhedonia in major depressive disorder over the coming weeks. It has truly been exciting times at Neurocrine this past year and I look forward to discussing many of our pipeline programs with you at our Analyst Day. I’ll stop here and turn it back to Kevin.
Kevin Gorman: Thank you, Eiry. Nikki, I think we’re ready for your questions now.
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