FBIOP 全部逐字稿

Fortress Biotech, Inc.(FBIOP)Q2 2026 法說會逐字稿

33 段

管理層發言

OperatorOperator

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to Journey Medical's Second Quarter 2026 Financial Results and Corporate Update Conference Call. Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of this call will be available approximately one hour after the end of the call for approximately 30 days. I would now like to turn the call over to Jaclyn Jaffe, the company's Senior Director of Corporate Operations. Please go ahead, Jaclyn.

Jaclyn JaffeSenior Director, Corporate Operations

Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical's leadership team are Claude Maraoui, Co-Founder, President and Chief Executive Officer; Joseph Benesch, Chief Financial Officer; and Ramsey Alloush, Chief Operating Officer and General Counsel, who will participate in the Q&A portion of the call. During this call, management will be making forward-looking statements, including statements that address, among other things, Journey Medical's expectations for future performance, operational results, financial condition and the receipt of regulatory approvals. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For 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, the Form 8-K filed with the SEC today and the company's press release that accompanies this call, particularly the cautionary statements in it. 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 or as a substitute for results prepared in accordance with GAAP. For a reconciliation of this non-GAAP financial measure to net loss, its most directly comparable GAAP financial measure, please see the reconciliation table located in the company's earnings press release. The content of this call contains time-sensitive information that is accurate only as of today, Wednesday, August 12, 2026. 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 is now my pleasure to turn the call over to Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical.

Claude MaraouiCo-Founder, President and Chief Executive Officer

Thank you, Jaclyn, and good afternoon to everyone on the call today. We continue to make solid progress in our business in the second quarter as we delivered strong revenue growth and improved profitability during the period. Emrosi revenues were $8.1 million in Q2, up significantly year-over-year and sequentially from the first quarter on higher prescription volume, improving payer reimbursement and a significant step-up in the number of dermatology writers prescribing the brand. These metrics not only trended positively, but also showed acceleration, and we expect this progress to continue in the coming quarters. Our total net product revenues for the second quarter rose by 23% year-over-year, while operating expenses increased by less than 1% compared to Q2 of last year. We remain focused on delivering strong top line growth and leveraging our proven dermatology commercial infrastructure. We are executing on these initiatives and as a result, we generated positive EBITDA in the second quarter. With this performance, we continue to believe that 2026 will be a breakout year for Journey Medical with respect to both revenue growth and profitability. Emrosi prescriptions totaled approximately 36,000 in the second quarter, up from about 30,000 total prescriptions in the first quarter of this year. This represents approximately 20% sequential quarterly growth for the product, which is up from the 11% sequential quarterly prescription growth seen last quarter. Importantly, the growth is being driven by new prescriptions in addition to refills with successive increases in NRxs on a monthly basis. In June, we saw a strong increase with over 5,300 new prescriptions filled, up from an average of 4,700 NRxs in the preceding three months. This was an all-time monthly high for the product. We reported last quarter that approximately 3,700 unique dermatology prescribers had written a prescription of Emrosi. Today, I am pleased to report that there are now over 4,500 unique prescribers writing for the brand. This is more than a 40% increase in Emrosi prescribers from the 3,200 prescribers that we had at the end of 2025. We believe that these accelerating trends are encouraging and demonstrate that as more prescribers and patients gain experience with Emrosi, product loyalty will increase and the franchise value will continue to compound. As we had planned, we hired an additional five dermatology sales professionals into our commercial organization during the second quarter. These experienced representatives joined the company in late July and were recently deployed into the field. The time to fill these relatively large sales territories couldn't be better, and we expect that contributions from these new representatives will add to our already strong market penetration efforts. With over 15,000 dermatologists in the United States, there is significant room for us to grow our base of prescribers. We are increasing our peer-to-peer marketing activities, and we remain active at key dermatology medical conferences to expand awareness of Emrosi's superior clinical benefits in the treatment of rosacea. The superior head-to-head efficacy results demonstrated in our Phase III clinical trials comparing Emrosi to the only other branded oral rosacea treatment, Oracea, continue to be central in driving adoption throughout the dermatology community. Emrosi's placebo-like safety and tolerability profile is proving to be durable, which is another important factor in recruiting new prescribers. From the patient perspective, Emrosi's rapid onset of action and superior skin clearing effects compared to Oracea are key and real-world patient experiences are supporting a growing base of loyal end users. Helping us to further broaden awareness of Emrosi in the market, we expect to announce new journal publications for the product in the coming quarters, and we believe that Emrosi has the potential to be incorporated into the consensus treatment guidelines for rosacea. The payer community is also taking note of Emrosi's early success in the market, and we are continuing to make progress with the downstream health plans. Importantly, the calculated average selling price for Emrosi based on prescriptions increased in Q2 over Q1, after increasing previously in Q1 over Q4, as reimbursed prescriptions are becoming an increasing part of the business mix. As Emrosi's formulary status improves, we believe that our ASP will continue to rise. Earlier this year, we completed our agreements with all the top three GPOs in the nation, bringing plan access for Emrosi to over 169 million of the 192 million covered commercial lives in the U.S. With those agreements in place, our focus is to pursue high-quality formulary coverage with the downstream health plans, meaning a single step edit or better. We made good progress in the second quarter as the percentage of commercial lives with high-quality formulary coverage increased from 34% in Q1 to approximately 38% currently. Supporting this positive trend, a large national health plan placed Emrosi on its formulary in early August, and we expect to see traction from that addition this quarter. And now I will turn the call over to our CFO, Joe Benesch, to review our second quarter financial results.

Joseph BeneschChief Financial Officer

Thank you, Claude, and good afternoon to everyone on the call. I'll now review our financial results for the second quarter of 2026. Total revenue for the quarter was $18.5 million compared to $15 million in the second quarter of 2025, reflecting a 23% increase from period to period. This growth was primarily driven by momentum from continued commercial demand for Emrosi which generated $8.1 million in net revenue for the quarter. Turning to gross margin. We reported a 67% margin for the second quarter of 2026, consistent with the prior year quarter. SG&A expenses were $10.9 million for the quarter compared to $11.9 million in the second quarter of 2025. The decrease was primarily due to the impact of launch-related spending for Emrosi in the prior year quarter. Our GAAP net loss narrowed to $300,000 or $0.01 per share basic and diluted compared to a net loss of $3.8 million or $0.16 per share basic and diluted for 2Q 2025. On a non-GAAP basis, both EBITDA and adjusted EBITDA were positive for the three- and six-month periods ended June 30, 2026. EBITDA reflected net income of $1.4 million and $1.1 million for the second quarter and the six-month period ended June 30, 2026, respectively, compared to net losses of $1.9 million and $4.1 million for the prior year quarter and the prior year-to-date period, respectively. Adjusted EBITDA, which is generally our EBITDA number less noncash share-based compensation expense, reflected net income of $2.9 million and $3.5 million for the second quarter and the six-month period ended June 30, 2026, respectively, compared to net losses of $500,000 and $1.4 million for the prior year quarter and the prior year-to-date period, respectively. We ended the quarter with $25.6 million in cash compared to $24.1 million as of December 31, 2025. In summary, our second quarter results reflect the continued execution of our plan to become sustainably EBITDA positive through revenue growth, margin improvement and expense optimization, which we intend to remain focused on. Thank you very much. I will now turn the call back over to Claude.

Claude MaraouiCo-Founder, President and Chief Executive Officer

Thank you, Joe. The second quarter was another productive period for Journey Medical with clear progress made on our business objectives. We are delivering on our goal to generate positive EBITDA for the remainder of the year with our net product sales growing significantly faster than our expenses. We are making solid progress toward becoming sustainably earnings and cash flow positive. Emrosi continues to gain market share in the rosacea treatment segment with prescription growth accelerating in Q2 and our base of new prescribers increasing at an impressive rate. With total prescriptions growing by 20% sequentially from the first quarter of this year, we believe that the promise of Emrosi is beginning to be realized broadly in the market. Importantly, patient experiences are validating that the superior benefits in our Phase III clinical trials are highly clinically meaningful. We remain focused on achieving high prescriber and patient satisfaction rates as this is the cornerstone of our efforts to build a strong base and deliver compounding growth for the brand. With market momentum building, our payer coverage continues to improve as well. The trends of higher ASPs since the beginning of the year is a reflection of that progress. Emrosi was added to the formulary of a major national health plan earlier this month and with other payer initiatives in various stages of progress, we continue to expect our ASP to improve throughout the back half of the year, fueling Emrosi sales growth. With our business moving in the right direction, we believe it was the perfect time to expand our commercial organization, and we did so by recently hiring and deploying five new sales professionals to fill new territories. We also executed on launching a niche dermatology product late in the second quarter called Eurax Cream. Our new sales professionals and this new addition to our product lineup are expected to augment our efforts to grow company revenues with Emrosi remaining a high priority detail in the Journey portfolio. With regards to business development activities, we continue to explore out-licensing opportunities for the commercial rights to our patented products in non-U.S. territories, in addition to the potential to in-license assets to expand our dermatology product offering and increase value for the company. We continue to expect that 2026 will be a breakout year for Journey Medical, and we will remain committed to delivering on our core objectives to improve the lives of patients, offer innovative treatment options to dermatology health care providers and to create long-term value for our shareholders. Thank you. Operator, we are now ready to open the lines for Q&A.

分析師問答

OperatorOperator

The first question today comes from Scott Henry with Alliance Global Partners.

Scott HenryAnalyst (Alliance Global Partners)

Claude, you gave a lot of color on ASP. I'm just going to ask a couple of follow-up questions. Were there any inventory movements in the quarter that can sometimes inflate or even deflate that ASP on a specific quarter?

Claude MaraouiCo-Founder, President and Chief Executive Officer

None. No.

Scott HenryAnalyst (Alliance Global Partners)

Okay. Oftentimes I'll see ASP drift up but it's not a straight line. You sound pretty confident that we could get sequential gains in the next couple of quarters as well. Is that the correct interpretation?

Claude MaraouiCo-Founder, President and Chief Executive Officer

That's correct. I think you'll see good progress from really from Q4 last year through Q1 to Q2, and our expectation is that we'll continue to gain better ASPs as more reimbursement from our payer strategy gets implemented and more reimbursements happen through the insurance companies. Regarding seasonality, it's a good question. Looking at market data over the past six to seven quarters, the total market has been pretty consistent. You might anticipate some changes from summer going into winter with cold weather in the next several months, but it's minimal and I would not put a lot of seasonality on it. We've had good growth consistent throughout the whole year. You'll see some weeks that are at the same level and then we get a bump up, and that's what we've seen with this brand on a consistent basis since we launched it in 2026. We just got Symphony numbers for July: we had about 13,000 prescriptions for Emrosi in June, and now we have approximately 14,000. So we've increased in a good fashion. New prescriptions are up. The trends are very strong. We had about 5,300 new prescriptions in June; the last three months preceding that averaged about 4,700 new prescriptions a month. The trends are very positive. From closing out 2025, we had about 3,200 prescribers. We moved that up to approximately 3,700 prescribers ending Q1, and we're close to 4,500-plus prescribers right now. More physicians are adopting the product, and it's looking very positive.

Scott HenryAnalyst (Alliance Global Partners)

Okay. Some great momentum there. Just shifting gears, a couple of the other products. QBREXZA was down a little bit in the quarter. That's kind of the second product that really matters here now. How do you see that product? Is that a flattish product? Or should we think about that as a declining product? Just wanted to hear your thoughts on the big picture long-term view on QBREXZA in the next four to six quarters?

Claude MaraouiCo-Founder, President and Chief Executive Officer

QBREXZA is a fantastic product and is very meaningful to the company. Right now, it's second out of the bag in terms of promotion with our field sales force; obviously Emrosi is first. We have great contribution from QBREXZA, very consistent over the time that we've had it. It brings in roughly about $25 million to $26 million annually. You'll see some up and down quarters with the brand, and this past one was a little light. I would attribute that to a few things: patient mix and payer mix, which we don't control, and residual effects from insurance deductible resets at the beginning of the year that can leak into Q2. We are entering a very strong season for hyperhidrosis with the hotter summer months. We had an extremely strong month of June; we hit over 14,000-plus prescriptions, about 14,500 to be exact. As I mentioned with Emrosi, we just got the July numbers and we're just shy of the 15,000 mark. Demand is increasing. Patient satisfaction with the brand is extremely high. It's convenient to use any time of the day or evening with no usage restrictions, and the simple use makes it very friendly. The fact there's no aluminum-containing ingredients in the brand makes it appealing. The brand is growing and we see great contribution. I would expect consistency similar to what you've seen over the last couple of years.

OperatorOperator

The next question comes from Mayank Mamtani with B. Riley Securities.

Mayank MamtaniAnalyst (B. Riley Securities)

Maybe on operating leverage, if I could start there. Your SG&A stayed unchanged while you're reporting very strong commercial KPIs. Should we expect a step-up in SG&A starting with 3Q with the corporate developments you've talked about, including the niche launch? And I have a few follow-ups after that.

Joseph BeneschChief Financial Officer

Yes, Mayank. The answer is yes, somewhat. You're not going to see any surprises, but we do have some marketing programs and some advertising programs that we will probably implement in the third and fourth quarters. Overall, I expect to see the percentage of revenue from SG&A remain pretty consistent.

Mayank MamtaniAnalyst (B. Riley Securities)

Claude, you talked about the major national plan added in early August. How does that impact net ASP in the second half or what you've seen already relative to the improvement in Q1 and Q2? On the refill rate that continues to climb, is there a year-end refill rate number that you have in mind based on trends? And how is your unique prescriber number moving — is there a correlation between those two big KPIs you're tracking?

Claude MaraouiCo-Founder, President and Chief Executive Officer

I'll start with the refill rate and prescriber correlation. Refill rates are very important. We have been committed to our message around the Phase III clinical trials — our commercial team is executing and discussing four-month trials, and I think it's resonating with prescribers. As more prescribers come on board, once they see patients return, they get more comfortable with the brand. Refill patterns vary: sometimes a dermatologist will write one prescription plus three refills consistent with our trials, but physicians will tailor refills to the patient's presentation. As we onboard new prescribers, the refill rate should rise. For July, which just came in as an all-time high month with 14,000 prescriptions, our refill rate for that month was at 1.5 plus the regular fill, which you can think of as approximately 2.5 when you factor new plus refills. New prescriptions have also increased from an average of about 4,700 to about 5,300 per month. On the national health plan addition, I'll ask Ramsey to comment on the formulary impact and what we expect for the rest of the year.

Ramsey AlloushChief Operating Officer and General Counsel

Mayank, thanks for the question. With this new national formulary on board, we expect improvement to ASP. This is a very large national plan. As of April, we had signed with all three major GPOs, so in the second quarter we did have some number of lives come over from that third GPO. This national formulary addition is in addition to that and will increase our share of lives with high-quality coverage. We currently talk about 38% quality of the 192 million lives having access to Emrosi with a single-step therapy or better. Adding this new national formulary will increase that number. Single-step coverage is the least friction for patient access and prescription adjudication. We have ongoing negotiations and presentations with other large national formularies. Being successful with this recent add should help our momentum going forward. We expect milestones to be hit throughout Q3, into Q4 and into 2028 as well.

Mayank MamtaniAnalyst (B. Riley Securities)

Great. My final question on ex-U.S. out-licensing efforts, including for Emrosi: is there anything IP-related that may be playing a role there? Or is it just that these things can take a while, especially ex-U.S. where dynamics are different?

Ramsey AlloushChief Operating Officer and General Counsel

I'll take that. We acquired global rights and maintain a global patent portfolio for Emrosi, QBREXZA and AMZEEQ. QBREXZA is available in Japan with our partner Maruho, and we have out-licensing in Korea, Taiwan and other ASEAN countries. AMZEEQ is available in China with our commercial partner, which launched about a year ago. We continue to have discussions regarding out-licensing these brands, and Emrosi is a key focus. We have IP protection across Europe, Canada, Australia, New Zealand, Japan and other parts of Asia, so the IP robustness and market opportunity exist. That said, international deals can take time to negotiate to get the right structure and adapt to local regulatory and market conditions. Our primary focus remains making Emrosi the standard of care in the U.S., but we have ongoing discussions with other companies about opportunities in international regions, and we will provide updates when something definitive is available.

OperatorOperator

The next question comes from Brandon Folkes with H.C. Wainwright. Europe, Canada, Australia, New Zealand, Japan and other parts of Asia show IP robustness and market opportunity. That said, international deals can take time to negotiate to get the right structure and adapt to local regulatory and market conditions. Our primary focus remains making Emrosi the standard of care in the U.S., but we have ongoing discussions with other companies about opportunities in international regions, and we will provide updates when something definitive is available.

Brandon FolkesAnalyst (H.C. Wainwright)

Maybe just two for me. First, staying on Emrosi: you look to be making very good progress on gross-to-net and on volume. Where is the remaining friction in access today, including prior authorization, especially that friction you believe you could remove or loosen over the next 12 months? Second, can you give more color on your expectations for Eurax — when it launched in the quarter and how you envision that product growing over time?

Claude MaraouiCo-Founder, President and Chief Executive Officer

Eurax is the correct name, Eurax Cream, 10% crotamiton. This is an antipruritic product — nonsteroidal, non-histaminic and fragrance-free. We worked to enhance the formulation. We picked this brand up a number of years ago and believe it's an improved formulation that will be welcomed by the dermatology community for patients with significant itching. We trained our commercial team in June and launched the brand in July. It's brand new. In our portfolio it sits behind QBREXZA in the third position: Emrosi first, QBREXZA second, then Eurax. We're starting to see traction and getting positive feedback from dermatology physicians. It's early, but we like what we're hearing. It's included in the compensation plan for our commercial team, so there is focus and promotion behind it. We'll be tracking prescriptions, physician counts and other KPIs for the brand. In terms of access and managed care friction, I'll ask Ramsey to jump back in to discuss specific barriers such as prior authorizations and what we are doing to reduce friction.

Ramsey AlloushChief Operating Officer and General Counsel

Brandon, more specifically on friction: we have two concepts we track. One is 'access' which measures the pathway to a prescription and is around 169 million covered lives; the other is 'quality' which is about having single-step therapy or better, currently about 38% of 192 million lives. The delta between those — about 80 to 90 million lives — may have larger barriers like prior authorizations or double-step requirements. Our job is to identify those bottlenecks and work with plans to get Emrosi down to our benchmark single-step therapy or better. Clinically, we have a strong value proposition with head-to-head data showing faster results and a favorable safety profile. From a payer perspective, there's also a strong financial profile. However, rosacea is not as highly managed a category as areas like GLP-1s or certain oncology drugs, so it can take more time. We have strong contacts at the important plans and are engaging them to explain why certain utilization management policies, like a double step or prior authorization, are not appropriate for Emrosi given the data and the financial profile. Reducing those barriers should allow scripts to go through at a higher rate and improve reimbursement, and we'll continue this work through Q3, Q4 and into 2028.

Claude MaraouiCo-Founder, President and Chief Executive Officer

To add, our market access team is negotiating potential look-backs and other arrangements — six months, twelve months or longer. We examine prior topical or oral therapy requirements and work the 'and/or' language with plans. Our strategy is to focus on reducing friction and getting patients on what we believe is currently the best oral treatment for rosacea. Taking the time to negotiate appropriately makes business sense and positions us to widen access in a sustainable way.

OperatorOperator

The next question comes from Thomas Flaten with Lake Street. To add, our market access team is negotiating potential look-backs and other arrangements, six months, twelve months or longer. We examine prior topical or oral therapy requirements and work the 'and/or' language with plans. Our strategy is to focus on reducing friction and getting patients on what we believe is currently the best oral treatment for rosacea. Taking the time to negotiate appropriately makes business sense and positions us to widen access in a sustainable way.

Thomas FlatenAnalyst (Lake Street)

Congrats on the Emrosi performance. With respect to the new reps that were hired, can I assume those were white space hires? Or are you already territory splitting?

Claude MaraouiCo-Founder, President and Chief Executive Officer

Out of the five new hires, most are white space hires, but we do have areas where the number of dermatologists and penetration are better served by splitting territories. So it's a mix of both.

Thomas FlatenAnalyst (Lake Street)

With respect to physician utilization, have they prioritized a specific element of your efficacy — time to effect or overall resolution of erythema — as the driving reason for their use?

Claude MaraouiCo-Founder, President and Chief Executive Officer

Physician feedback has been strong around efficacy. The superiority factor we achieved is resonating with physicians and patients. When physicians see patients back after a month or two, the reinforcement from the patient and the clearance rate is notable. Our trials show we achieve the results in essentially half the time compared to the comparator, and that is a major driver. Coupled with a strong safety and tolerability profile, physicians are building confidence in Emrosi.

Thomas FlatenAnalyst (Lake Street)

Are there specific subtypes of rosacea patients they're primarily using it on, or are they using it more broadly?

Claude MaraouiCo-Founder, President and Chief Executive Officer

We're indicated for papulopustular rosacea, and physicians are using Emrosi broadly within moderate to severe patients in that category. That is the primary niche for the brand at this time.

OperatorOperator

This concludes our question-and-answer session and concludes the conference call today. Thank you for attending today's presentation. You may now disconnect.

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