Fortress Biotech, Inc. Q2 FY2022 Earnings Call

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the Journey Medical's Second Quarter 2022 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and it's also being recorded for playback purposes. Our webcast replay of the call will be available approximately one hour after the end of the call for approximately 30 days. I would like now to turn the call over to the Company's Investor Relations. Please go ahead, sir.

Thank you, Carolyn. Good afternoon, everyone. And thank you for participating in today's conference call. Joining me from Journey Medical Corporation's leadership today are Claude Maraoui, Co-Founder President and Chief Executive Officer, Ernest De Paolantonio, Chief Financial Officer, Ramsey Alloush, General Counsel and Dr. Srinivas Sidgiddi, Vice President of Clinical Development and Medical Affairs, who will also be joining us for the question-and-answer session. During this call, management will be making forward-looking statements including statements that address Journey Medical's expectations for future performance or operational results. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in Journey Medical's most recently filed periodic reports, on Form 10-K and Form 10-Q, Form 8-K filed with the SEC today, and the company's press release that accompanies this call, particularly the cautionary statements within. Today's conference call includes non-GAAP financial measures that Journey Medical believes can be useful in evaluating its performance. You should not consider this additional information in isolation, nor as a substitute for results prepared in accordance with GAAP. For reconciliation of this non-GAAP financial measures to net loss, its most directly comparable GAAP financial measure, please see the reconciliation table located in the company's earnings press release. The contents of this call contain time-sensitive information that is accurate only as of today, August 9, 2022. Except as required by law, Journey Medical disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It's now my pleasure to turn the call over to Claude Maraoui, Co-Founder President and Chief Executive Officer. Claude.

Thanks, Jules. Good afternoon, and thanks to everyone for joining our second quarter 2022 conference call. Journey continued to show solid growth in the second quarter of 2022, despite the challenges of supply chain delays during the quarter that reduced the availability of product for sale. However, this was a temporary setback as these delays were resolved in July, and we feel confident that we will recover a significant portion of these lost revenues over the remainder of the year. Our flagship products QBREXZA and Accutane continue to gain momentum in the market along with the additional contributions from our recently acquired products AMZEEQ and ZILXI, coupled with the launch of one additional prescription product in the second half of this year, positions us for yet another year of record revenue growth. We achieved net sales of $18.3 million, an increase of 20% when compared to the second quarter of 2021, which was driven primarily by the strong performance of QBREXZA and ACCUTANE. We began selling these products in the second quarter of 2021, which achieved combined net sales of $6.5 million versus this quarter’s combined net sales of $11.3 million, which represents a growth rate of 74%. This growth was slightly offset by product shortages in the quarter for Ximino and Exelderm, as well as the continued generic competition for Targadox, which was $3 million less than the prior two years' period. Looking forward, we will continue executing our strategy of supporting and growing our newly acquired and launched products, including QBREXZA, Accutane, AMZEEQ, and ZILXI. The second quarter was also impacted by an update to our managed care claim estimates, particularly for the recently acquired assets AMZEEQ and ZILXI, as the actual managed care claim experiences emerged greater than expected. On the development front, we continue to be excited about the ongoing progress of our pivotal Phase 3 clinical program for DFD-29, which is being evaluated for the treatment of papulopustular rosacea in adults. Patient enrollment is tracking according to plan, and with the recent addition of nine sites this quarter, we have already achieved and reached 45% of our targeted enrollment of 640 patients in the two trials. We anticipate announcing top-line data from the trials in the first half of 2023, along with the submission of our new drug application in the second half of 2023. To reiterate, the market opportunity for DFD-29 is massive, as an estimated 16 million patients in the U.S. suffer from rosacea, which equated to an estimated $1 billion in prescription sales in 2021. The Phase 2 clinical data for DFD-29 demonstrated nearly double the efficacy overall compared to the current market leader with $340 million in prescription sales in 2021. We estimate that our peak net sales for this product will be in excess of $100 million. While we faced some unforeseen challenges this quarter, we are confident that these issues have been resolved, and we look forward to another record year of growth in sales. The foundation of our future growth continues to be the expansion of our product portfolio through in-licensing and acquisition of commercial and late-stage development assets that will allow us to continue to leverage our industry-leading sales force. With that, I'll now turn the call over to Ernie, our Chief Financial Officer, who will review our financial results for the second quarter.

Thanks, Claude, and hello, everyone. I will now review the second quarter financial results. Total net revenues increased by $3 million, or 20%, to $18.3 million for the three months period ending June 30, 2022, from $15.3 million for the three month period ending June 30, 2021. Net revenue growth from period to period is primarily due to year-over-year revenue growth of QBREXZA acquired and launched during the second quarter of 2021 and revenue growth in ACCUTANE, which was launched late in the first quarter of 2021. In addition, the increase from period to period is driven by incremental net revenues from our newly acquired and launched products, AMZEEQ and ZILXI, in January of 2022. Offsetting the increase is a decrease in revenue of $3 million from Targadox due to continued generic competition and XIMINO and EXELDERM supply delays from our contract manufacturers in the second quarter. As Claude previously mentioned, these delays were resolved in July, and we currently have sufficient inventory to meet our current and future demand. Cost of goods sold increased by $0.1 million to $7.6 million for the three month period ended June 30, 2022, from $7.5 million for the same period of the prior year. This increase is primarily due to higher product cost of goods sold of $0.8 million, driven by the higher volume of product sales, and non-cash amortization of $0.3 million related to our acquired intangible assets due to the acquisition of AMZEEQ and ZILXI. This increase is offset by a net $1 million decrease in product cost of goods related to the inventory step-up of units sold from the acquired finished goods to QBREXZA in 2021. Selling, general and administrative expenses increased by $7.4 million to $15.2 million for the three month period ended June 30, 2022, from $7.8 million for the three month period ended June 30, 2021. The increase is primarily attributable to the expansion of our sales force, marketing expenses related to our expanded product portfolio, patent litigation expenses, compliance, and other costs associated with being a public company. Research and development expenses increased to $2.6 million for the three month period ended June 30, from $29,000 for the three month period ended June 30, 2021. The increase is attributable to clinical trial expenses of our DFD-29 candidates, for which dosing began in March of 2022. These expenses will increase as more patients are fully enrolled in the trials in the coming months. Research and development licensing decreased by $13.7 million or 100% for the three month period ended June 30, 2022, from the prior period of the same quarter in 2021. The prior period expense reflects the acquisition of DFD-29 from Dr. Reddy for $10 million, plus a fair value of the contingent payment due to Dr. Reddy of $3.7 million. Net loss attributable to common shareholders was $7.5 million, or $0.43 per share basic and diluted for the second quarter of 2022, compared to a net loss attributable to common shareholders of $11.9 million, or $1.30 per share basic and diluted for the second quarter of 2021. Our non-GAAP adjusted EBITDA for the quarter after adjusting for R&D expenses related to DFD-29 was a loss of $2.6 million, and on a year-to-date basis is negative $263,000. This does not take into account the impact that certain product delays had on our sales in the quarter. We believe that this non-GAAP adjusted EBITDA figure will turn positive in the upcoming quarters, as it has been since 2017. At June 30, 2022, we had $38.1 million in cash and cash equivalents, compared to $49.1 million at December 31, 2021. As mentioned in our press release, we received encouraging news regarding our cybersecurity breach, which resulted in losses of $9.5 million. The FBI and the Department of Homeland Security informed us that a significant amount of cryptocurrency associated with the breach has been seized and will soon enter the liquidation process for the eventual return to Journey Medical. We cannot estimate the exact amount or the timetable for receiving the funds at this time. Finally, in August, we borrowed the additional $5 million available from the second tranche of the term loan with East West Bank. This additional $5 million is part of our operating plan to support the DFD-29 clinical program and working capital. With that, I will turn the call back over to Claude. Thank you.

Thank you, Ernie. We are looking forward to achieving significant milestone events in the second half of 2022, including the completion of enrollment for both Phase 3 clinical trials for DFD-29 and the launch of another prescription dermatology product to add to our portfolio. With a strong foundation and the continued momentum in our new products, we expect to achieve another year of record revenues in 2022. I will now turn the call over to the operator for questions. Thank you.

The first question comes from Brandon Folkes with Cantor Fitzgerald.

Maybe just for me starting off on DFD-29. What do we need to see in the data in order to differentiate the product from others? And then how does the enrollment at this stage compare to your initial expectations?

I'll just start. I'm going to hand it over to our Vice President of Clinical Development, Dr. Srinivas Sidgiddi. But overall, in summary, we are on track regarding the clinical trials for DFD-29, and enrollment is proceeding according to our plan. I'm going to have Dr. Sidgiddi take it from here and give you some more details. Sidgiddi?

The enrollment for the two studies, the Phase 3 studies MVOR-1 and MVOR-2. So that's the acronym we have given to the Phase 3 studies. MVOR essentially stands for minocycline versus placebo in rosacea. The enrollment for the two studies is going on as planned, there is a slight delay on the European leg of the second study, and that is due to things that are out of our control, such as regulatory approvals, which have been delayed. But overall, the enrollment is still within what we had anticipated, and within the buffers that we have had. So that's the first question. The second part of the question was about differentiation. In rosacea, we anticipate seeing a significant improvement on the inflammatory lesions and the investigator global assessment, which are the two primary endpoints for this study. We would essentially like to see a significant difference in the inflammatory lesion counts, as well as the erythema component of rosacea. Those are the two things that would differentiate us from the other products.

Next question comes from Mayank Mamtani with B. Riley FBR.

Just maybe first on the QBREXZA sales. Could you comment on what specific campaigns are you seeing resonate well with your customers? And then also, if you could give us a sense of repeat versus new prescriptions? Again, I understand it's still early days, but if you could comment on how you're seeing that trend? And then I have a couple of follow-ups.

Regarding QBREXZA, we have really focused on a digital campaign with the brand, which encompasses a few areas. One is really building awareness with the demographic in the age group that we're targeting, and I think it's off to a really good start. We're focused on, for example, with Facebook, Instagram, and other social media platforms to increase awareness, education, and drive inquiries about this to the dermatology providers when these patients go and see their dermatologist. I believe that's how it's been progressing. Our impressions and hits have all been increasing nicely, and I think that's really corresponded well in terms of prescription demand. For example, from Q1 to Q2, we have had approximately a 25% increase in prescription growth. So I think the campaign is working well, and we're making some progress on that front. Could you repeat your second part of your question, please?

Repeat versus new prescriptions?

Sure, just as far as looking into the new prescriptions with Symphony data, as of the most recent month, new prescriptions have been trending upward. In January, for example, we were at 3,600 prescriptions for the month in new prescriptions, and in June, which is the latest data, we were up to approximately 5,400 prescriptions. And when you look at that comparator and analyze the ratio of total prescriptions, we've more than doubled that. So for example, again, new prescriptions in June at 5,400 and total prescriptions at approximately 12,000. I think that's a good indicator and sign that we are increasing our refill rates as well.

Great. I'd like to follow up on the earlier question that Srini addressed. Could you share your assumptions regarding the placebo and active comparator in the two studies, MVOR-1 and MVOR-2? Additionally, Sri, could you provide your expectations for the effect size on the IGA and how it might be influenced by the lesion count reduction endpoint?

Sure, Mike, thank you so much for the question. It's a really good question. We have looked at the efficacy that we saw in the Phase 2 study that was conducted in Europe, in which DFD-29 was one of the arms, and we had Oracea, that is the European Oracea, as well as placebo. We have used those estimates in the calculation of the sample sizes for this Phase 3 program. To briefly summarize the efficacy we observed there, we had an IGA treatment success of 66% for the DFD-29 40 mg, versus 33% for Oracea, and 11% for placebo. Those were the estimates that we used in calculating sample sizes.

Very helpful. And my final question, just high-level, maybe for Claude and Ernie, at what stage will you feel comfortable talking about a longer-term projection and maybe discussing giving guidance? I understand you have some one-off supply chain dynamics and certain products, competitive dynamics. So I’m just curious, at what point do you feel you'd have a good understanding for thinking about two or three quarters ahead and maybe even planning for the next year from a financial guidance standpoint?

Sure, first of all, we are getting closer to giving guidance in terms of getting the new assets on board that we acquired in January with AMZEEQ and ZILXI. I think in the next two quarters, definitely towards the beginning of next year, we'll be able to provide guidance moving forward with a very comfortable range. Ernie, I'd like you to add anything on that if you'd like.

We're still getting our portfolio of products normalized before we can make estimates for our earnings. But as Claude said, in the upcoming quarters, you'll see us start to provide guidance.

Sri, could you provide an update on how many sites we currently have enrolled for the DFD-29 study?

So we initially planned to have 29 sites in both studies MVOR-1 and MVOR-2, which means that we would have 58 sites for the U.S. and Europe combined. We plan to get 640 subjects from these 58 sites. Currently, we stand at 30 sites that are enrolled in the MVOR-01 study, entirely in the United States. In MVOR-2, we have 15 sites in the U.S. that have been enrolling patients, and we have 14 sites that are coming up in Europe. Of the 14, we have nine sites in Germany that are initiated or in the process of being initiated. We are awaiting approval from the Polish competent authority, after which we will be starting the four sites in Poland as well. As of now, we have 29 sites in the DFD-29 study and the 15 sites in the U.S. for the MVOR-02 study, plus additional five sites that have been initiated in Germany as of today.

Thank you very much, gentlemen, and that concludes our question-and-answer session. I would like now to turn the call back over to Claude Maraoui. Please go ahead, sir.

Thank you very much. I want to thank all of you for participating in today's call and your interest in Journey Medical. We look forward to sharing our ongoing progress when we report our third quarter results in November. Thank you and have a good day.

This conference is now concluded.