管理層發言
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. At this time, all participants are in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by 0. 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.
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-Q and the Form 8-Ks 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, 08/12/2026. 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.
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. Amrozi revenues were $8.1 million in Q2, up significantly year over year and sequentially from the first quarter, driven by 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. Amrozi 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 new prescriptions 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 new prescriptions 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 for Amrozi. 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 Amrozi 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 Amrozi, 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 could not 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 Amrozi's superior clinical benefits in the treatment of rosacea. The superior head-to-head efficacy results demonstrated in our Phase III clinical trials comparing Amrozi to the only other branded oral rosacea treatment, Oracea, continue to be central in driving adoption throughout the dermatology community. Amrozi'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, Amrozi'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 Amrozi in the market, we expect to announce new journal publications for the product in the coming quarters. We believe that Amrozi has potential to be incorporated into the consensus treatment guidelines for rosacea. The payer community is also taking note of Amrozi's early success in the market, and we are continuing to make progress with downstream health plans. Importantly, the calculated average selling price for Amrozi 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 Amrozi'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 planned access for Amrozi 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 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 38% currently. Supporting this positive trend, a large national health plan placed Amrozi on its formulary in early August, and we expect to see traction from that addition this quarter. I will now turn the call over to our CFO, Joe Benesch, to review our second quarter financial results.
Thank you, Claude, and good afternoon to everyone on the call. I will now review our financial results for the second quarter of 2026. Total revenue for the quarter was $18.5 million compared to $15.0 million in the second quarter of 2025, reflecting a 23% increase period to period. This growth was primarily driven by momentum from continued demand for Amrozi, 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 Amrozi in the prior year quarter. Our GAAP net loss narrowed to $0.3 million, 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 six-month periods ended 06/30/2026. EBITDA reflected net income of $1.4 million and $1.1 million for the second quarter and the six-month period ended 06/30/2026, 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 06/30/2026, respectively, depicting net losses of $0.5 million 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 12/31/2025. In summary, 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.
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, and with our net product sales growing significantly faster than our expenses, we are making solid progress toward becoming sustainably earnings and cash-flow positive. Amrozi 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 Amrozi 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. Amrozi 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 Amrozi sales growth. With our business moving in the right direction, we believed 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 Urox Cream. Our new sales professionals and this new addition to our product lineup are expected to augment our efforts to grow company revenues, with Amrozi 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 healthcare 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
The question-and-answer session will now begin. If you are using a speakerphone, please pick up your handset before pressing the keys. At this time, we will pause momentarily to assemble our roster. The first question today comes from Scott Henry with Alliance Global Partners. Please go ahead.
Thank you, and good afternoon. Claude, you gave a lot of color on Amrozi, so 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 deflate that ASP in a specific quarter?
None. No.
Okay. Oftentimes I see this where the ASP is drifting up but it is not a straight line, but you sound pretty confident that we could get sequential gains over the next couple of quarters as well. Is that a correct interpretation?
That is correct. I think you will see good progress from Q4 last year through Q1 to Q2, and our expectation is that we will continue to gain better ASPs as more reimbursement from our payer strategy gets implemented and more reimbursements happen through the insurance companies.
Okay. Great. I do not know if you can speak to seasonality. Q2 was great and you had some significant gains, but it has kind of plateaued for the past couple of weeks around 3,000 a week. Is there any seasonality where we may get a boost coming out of the summer months? Any thoughts on that?
That's a fair question. Looking at market data over the past six to seven quarters, it's been pretty consistent. From summer going into winter with colder weather in the coming months, you may see some changes, but they are minimal and I would not put a lot of seasonality on it. We have had good growth consistently throughout the year. You will see some weeks that are at the same level and then we get a bump up, and that is what we have seen with this brand since launch in 2026. We just got Symphony numbers for example for July. We had about 13,000 prescriptions for Amrozi in June and now we have approximately 14,000, so we have increased it in a good fashion. New prescriptions are up and the trends are very strong. We hit about 5,300 new prescriptions; the last three months preceding that averaged about 4,700 new prescriptions. So the trends are very positive. In my opening remarks we talked about unique prescribers: from the end of 2025 we had about 3,200 prescribers, we moved that up to approximately 3,700 prescribers at the end of Q1, and we are close to 4,500 prescribers now. More physicians are adopting the brand and it looks positive.
Okay, yes, some great momentum there. Just shifting gears, a couple of the other products: QBREXZA was down a little bit in the quarter. How do you see that product? Is that a flattish product, or should we think about it as declining? Just want to hear your thoughts on the big picture long-term view on QBREXZA over the next four to six quarters.
QBREXZA is a fantastic product and very meaningful to the company. Right now, it is second in our promotion efforts behind Amrozi. We have had great contribution from QBREXZA consistently; it brings in roughly about $25 million to $26 million. You will see some up and down quarters with the brand; this past one was a little light, which I would attribute to a few things: patient mix and payer mix, which we do not control, and some residual effects from insurance deductible resets at the beginning of the year that can leak into Q2. We are going into a very strong season for hyperhidrosis with the hotter summer months. We had an extremely strong month of June, hitting over 14,500 prescriptions. As mentioned with Amrozi, July numbers are just shy of the 15,000 mark. Demand is increasing, patient satisfaction with the brand is extremely high, and it is convenient to use any time of the day. The lack of aluminum-containing ingredients makes it appealing to many patients. The brand is growing and we see great contribution, so I would expect continued consistency over the coming quarters.
Okay, great. I will wrap it up there. Thank you for taking the questions.
Thank you.
The next question comes from Mayank Mamtani with B. Riley Securities. Please go ahead.
Yes. Good afternoon, team. Thanks for taking my questions, and congrats on a lot of progress here. Maybe on operating leverage to start: your SG&A stayed unchanged while you are reporting strong commercial KPIs. Should we expect a step-up in SG&A in the second half with the corporate developments you discussed, including the niche launch?
Sure. Joe, would you like to take that one?
Yes. The answer is yes, somewhat. You will not see any surprises, but we do have some marketing and advertising programs that we will probably implement in Q3 and Q4. Overall, I expect the SG&A as a percentage of revenue to remain pretty consistent.
Okay. Claude, you talked about the major national plan added in early August. How does that impact net ASP in the second half or what have you seen already relative to the improvement in Q1 and Q2? Also, on refill rates that continue to climb, is there a year-end number you have in mind based on trends, and how is the unique prescriber number moving? Is there correlation between these two KPIs?
I will start with the latter two points. Refill rates are very important. We have been consistent in our messaging about the Phase III clinical trials and our commercial team is executing on that message, including the four-month trial regimen. That messaging is resonating with prescribers. As more prescribers come on board and return patients, they will become more comfortable prescribing refills. Refill rates will go up and down depending on physician prescribing patterns—some may prescribe one prescription plus three refills per the trial design, while others will vary based on the patient's presentation. The month of July was an all-time high with 14,000 prescriptions. Our refill rate for that month is about 1.5 plus the regular fill; overall you could think of it as about 2.5 right now. New prescriptions have increased from an average of 4,700 to about 5,300 per month. So even though refill rates are compounding as more physicians prescribe, total prescriptions remain the most important metric and that line continues to show very strong positive growth. Mayank, I will ask Ramsey to comment on the national health plan and the potential impact for the rest of the year.
Hi Mayank, thanks for the question. Regarding the new national formulary, we expect an upward trajectory for ASP as this is a very large national plan. As of April, we had signed all three major GPOs, and in Q2 some number of lives came online from that third GPO. This national formulary is in addition to those agreements. We expect improvement and increased quality coverage: we currently talk about 38% of the 192 million lives having access to Amrozi with a single step therapy or better. Adding this new national formulary increases that number and reduces friction for patients in the adjudication process. We have a number of additional negotiations and presentations with other large national formularies ongoing, and we think success with this recent add will help momentum going forward. We expect good milestones to be hit throughout Q3 into Q4 and into 2028 as well.
Great. My final question on ex-U.S. out-licensing efforts, including for Amrozi: is there anything IP-related playing a role there, or is it mainly that these processes take a while given different regional dynamics?
I can take the out-licensing question. We acquired global rights and maintain a global patent portfolio for these brands. QBREXZA is available in Japan with our partner Maruho, and we have additional out-licensing in Korea, Taiwan, and other ASEAN countries. Amzeeq is available commercially in China with our partner Qdia; it launched about a year ago. We have ongoing discussions for additional out-licensing, and specifically for Amrozi, those negotiations are happening consistently. We have IP coverage globally including Europe, Canada, Australia, New Zealand, Japan, and other parts of Asia. The opportunity and the IP robustness are there, but these deals take time to reach the right structure and to navigate regional regulatory and political considerations. Our primary focus remains making Amrozi the standard of care in the U.S., but we believe there is great opportunity in other regions and will update as things become definitive.
Thank you.
The next question comes from Brandon Folkes with H.C. Wainwright. Please go ahead.
Hi, thanks for taking my questions and congrats on the quarter. Two questions on Amrozi: where is the remaining friction in access today, including payer access, especially friction you believe you could remove over the next 12 months? Second, I noticed Urox launched in the quarter—can you give more color on that product, when it launched, and how you envision it growing over time?
Yes. Urox is the correct name. It's a 10% crotamiton cream; an anti-itch, antipruritic product that is nonsteroidal, nonhistaminic, and fragrance-free. We worked to change and enhance this formula. This is a brand we acquired a number of years ago and we believe it will be welcomed in the dermatology community for patients suffering from significant itching. We trained our commercial team in June and launched the brand in July, so it is brand new in the market. In our portfolio, it is positioned behind QBREXZA in the third position, with Amrozi first, QBREXZA second, and Urox third. We are starting to see traction and positive feedback from dermatologists. It is early, but we expect it to be a good contributor to base business. We are tracking prescriptions, physician counts, and all major KPIs and the brand is included in our commercial compensation plan so it will receive focus and promotion. Regarding managed care and where friction remains, I will ask Ramsey to jump in.
Yes, thank you.
Brandon, on market friction: we talk about 'quality' access as the number with single-step therapy or better, which we estimate at 38% of lives, and we talk about 'access' as pathway to a prescription, closer to 169 million lives. The delta between those numbers—roughly 80 to 90 million lives—represents larger barriers such as prior authorization or a double step therapy. Our job is identifying those bottlenecks and working with plans to reduce them so Amrozi can reach our benchmark of single-step therapy or better. From a clinical perspective we have a strong value proposition with head-to-head data showing faster results versus Oracea and a strong financial profile. Payers are taking notice, but rosacea is not as highly managed a category as some other therapy areas, so it can take time. We are in active discussions with important plans to remove inappropriate barriers such as double steps or prior authorizations based on the clinical and financial profile. If we can reduce those barriers, we expect submission and adjudication rates to increase, which will improve reimbursement rates. We will continue this work through Q3, Q4, and into 2028.
Brandon, in terms of negotiations, our market access team is pursuing potential lookbacks—six months, 12 months, or a year-plus—and evaluating clinical and previous therapy criteria such as prior topical or oral use. We stand at about 38% quality coverage today, which is a good position, and we believe we can increase that number significantly while maintaining our strategy to reduce friction so patients can get the best oral treatment for rosacea.
The next question comes from Thomas Flaten with Lake Street. Please go ahead.
Hey, good afternoon. Congrats on the Amrozi performance. With respect to the new reps that were hired, can I assume those were white space hires or are you territory splitting?
Out of the five new reps, most are white-space hires, but we do have some areas where territory splitting made sense given dermatologist density and penetration. So it's a mix of both.
Got it. With respect to physician utilization, have they keyed in on a specific element of your efficacy—time to response, overall resolution, erythema—that is driving use?
Physician feedback has been very positive about efficacy. The superiority factor from our trials is resonating with patients and physicians. When physicians see patients one to two months after the initial prescription, the reinforcement from patients about clearance is notable. We achieve results in essentially half the time compared to Oracea, which is a major factor, combined with a strong safety and tolerability profile. Physicians are not getting pushback that they could have had with some other products, so they like what they are seeing.
Are there specific subtypes of rosacea patients that they are primarily using Amrozi on, or are they using it more broadly?
We are indicated for papulopustular rosacea, which covers moderate to severe disease. That is where the niche for the brand is right now; physicians are generally prescribing Amrozi for moderate to severe papulopustular patients.
This concludes our question-and-answer session, and concludes the conference call today. Thank you for attending today's presentation. You may now disconnect.