Greetings, and welcome to the Sol-Gel investor conference call a t this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during today's conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Mr. Alon Seri-Levy, CEO of Sol-Gel. Thank you, sir. You may begin. Thank you, operator, and hello everybody, and thank you for joining us on such a short notice. Together with me is our Executive Chairman, Mr. Mori Arkin, our CSO, Mr. Mamlok, and our VP of Clinical and Regulatory Affairs, Dr. Ofra Levy-Hacham. This morning, we informed about two exciting advancements we have made. Signing of a strategic partnership with Galderma regarding commercialization of EPSOLAY and TWYNEO in the U.S., and new pipeline findings and their implications for our future development plans that are in line with our vision to transform into the leading topical dermatology company. Before further discuss these two advancements, I kindly ask you to pay attention to this cautionary note on forward-looking statements. The cornerstone of our strategic partnership with Galderma is the innovation behind EPSOLAY and TWYNEO and the strong clinical results obtained for both assets. We are proud that Galderma has recognized the advantages of EPSOLAY and TWYNEO and their importance for rosacea and acne patients, and delighted that following this partnership, EPSOLAY and TWYNEO will have the potential to become the next key rosacea and acne market brand in the U.S. Galderma is the world's largest independent dermatology company. It has been the U.S. acne and rosacea market's leader for many years, achieving nearly $350 million in peak sales for Epiduo in acne and nearly $200 million in peak sales for Soolantra in rosacea. We therefore identified Galderma as our preferred strategic partner for making EPSOLAY and TWYNEO available to as many rosacea and acne patients as possible in the U.S., and for maximizing the market potential of these two assets for the benefit of Sol-Gel stakeholders. According to our agreement with Galderma, Sol-Gel will be entitled to receive up to $50 million in upfront and product approval payments, assuming both products are approved by the end of this year. Sol-Gel will also be entitled to mid-to-high teen percentage royalties of net sales and up to an additional $9 million in sales milestone payments. In addition, Sol-Gel has the option to regain commercialization rights five years following first commercialization, which we find very compelling, as EPSOLAY and TWYNEO are patent protected until 2040 and 2038 respectively, and we are pursuing additional patent applications for both programs. We carefully considered the alternative of go-alone and decided that given payers' current approach and investments required to go alone, that it would be more prudent to collaborate with a top-tier, well-established dermatology company rather than building our own marketing and sales force for only two drug products, as good as they may be. We may ever commercialize EPSOLAY and TWYNEO ourselves in five years, after their markets are well-established and after our pipeline candidates mature. In the meantime, the capital we gain from our partnership with Galderma and our partnership with Perrigo generics will be used to advance our promising pipeline of innovative topical formulations of roflumilast, tapinarof, and erlotinib, for which we have constructed comprehensive development and intellectual property strategies. It is now my pleasure to turn it over to our Executive Chairman, Mori Arkin. Mori, please. Thank you, Alon. As the Executive Chairman of the board of Sol-Gel, it was extremely important for me to join you today to review our new strategic direction and to highlight that this decision has been carefully considered and has the full support of our board. On this call, I will not only discuss the partnership for our lead branded drugs, EPSOLAY and TWYNEO, but also our vision of Sol-Gel moving forward, as we are now in a position to maximize the development of our assets while capturing a revenue stream from both our generic and branded product partners. Importantly, the structure of today's partnership announced with Galderma, a world leader in dermatology, allows us to deploy our capital to focus on our earlier-stage, high-value clinical candidates in our pipeline rather than on commercial expenses. In five years' time, I envision that Sol-Gel will be a company with a robust portfolio, with two established leading products in acne and rosacea, with roughly 40% profit margin, and two, possibly three, soon-to-be-launched products targeting the large markets for psoriasis, atopic dermatitis, and hyperkeratotic skin diseases including four of roflumilast, tapinarof, and erlotinib, each of which has promising potential. If we are able to capitalize on this opportunity, we'll be a stronger company, whether as a standalone company or as an independent division within a larger entity. Although a number of large pharmaceutical companies have moved into biologics, we expect topical therapy to continue to be the backbone of skin therapy for these complex diseases. It is therefore our goal to fill the gap that was created by Big Pharma abandoning topical R&D, and within five years, become topical innovators and the leading topical dermatology company. If our plan remains on track, we expect to realize significant value for both patients and shareholders. The programs that we are focusing on utilize active pharmaceutical ingredients that have already demonstrated efficacy in third-party Phase III trials, we believe that our new programs have the potential for success and in markets that offer high economic potential. To be clear, we believe these are not traditional risky Phase I assets, but pipeline programs that warrant significantly higher valuations. We're extremely energized and excited by this development. First, let us explain why we decided to pivot and partner our lead branded product candidate, EPSOLAY and TWYNEO. We are always seeking ways to maximize shareholder value, we carefully evaluated a number of options with respect to our branded products in our early-stage pipeline. We collectively decided that this opportunity with Galderma represented the most attractive path. It permits our branded indications in acne and rosacea to be promoted by the strongest dermatology sales force in the industry with deep prescribing relationships. We believe that Galderma, which is exclusively focused on dermatology, has the best ability to optimize our brands' future growth trajectory and ensure successful commercialization. This decision also expedites our path to profitability by conserving marketing expenditure while we benefit from up-front payment and sales royalties. Finally, it gives us the bandwidth to focus on developing other promising pipeline projects like novel formulations of roflumilast and tapinarof in the high-value topical market of psoriasis and atopic dermatitis. We believe that these compounds represent attractive development opportunities, and we have constructed a shrewd intellectual property strategy for each of these programs. Thanks to the enormous efforts of Dr. Alon Seri-Levy and Mr. Gilad Mamlok, we have reached an agreement announced today with Galderma that provides us with the best of all worlds. As we previously indicated, the main compounds that we are developing are topical roflumilast, SGT-510, topical tapinarof, SGT-310, and topical erlotinib, SGT-210. We said in our release today that in the second half of the decade, we aim to become the leading player in the roflumilast psoriasis market, which is forecasted by analysts to reach approximately $1 billion in 2028. The atopic dermatitis market similarly represents another $1 billion opportunity. By the end of 2022, we expect to have head-to-head data against a formulation of 0.3 roflumilast cream that we believe will be a very close approximation of the soon-to-be-launched roflumilast brand. We hope that this comparative study will highlight the unique features of our formulations and expect to initiate Phase II work in roflumilast shortly thereafter and to realize an inflection in value from this program. With respect to our roflumilast trial, we are extremely pleased with the highly encouraging results from a recent preclinical study using a validated psoriasis model that has been used to predict efficacy for marketed psoriasis drugs such as apremilast, Otezla, and several injectable biologics. What is unique about testing with this model is that drugs are tested on living human psoriatic skin, and therefore results are expected to mimic the clinical effect in humans. In this experiment, we tested our proprietary formulation of roflumilast and compared it to a 0.3 cream formulation of roflumilast created by Sol-Gel, each dosed once daily for two weeks. We also employed a positive control of the topical steroid, dexamethasone, given twice daily, which we know rapidly calms inflammation, as well as a negative vehicle control. In this study, six out of 10, or 60%, of the animals treated with our roflumilast formulation recovered, compared to three out of 10, or 30%, in the animals treated with roflumilast cream. Make note, this is not a spurious finding despite the small number of animals treated because the study was designed based on a pre-defined hypothesis that our formulation would be superior to the cream. These results were further supported by histological findings. As a result, we intend to advance our innovative SGT-510 formulation to clinical studies by the middle of next year. Shifting gears, tapinarof is another product that has comparable market potential, and therefore we are equally excited about this product candidate. Our enthusiasm stems from our expectation to be the only player besides the brand in the U.S. and the rest of the world for a number of years, offering innovative formulations or combinations, and increased patient access. In those markets where it would make sense to offer the product also in an unbranded form, we will do so via partnership with the competent players. If our trials are successful, our regulatory strategy to develop our formulation of tapinarof will consist of filing a new drug application, or NDA, via the 505(b)(1) pathway. We took into consideration that the 505(b)(1) regulatory pathway is more demanding and more costly than the 505(b)(2) regulatory pathway h owever, the latter pathway is associated with the Hatch-Waxman 30-month stay, which we prefer to avoid. The 505(b)(1) route will enable us early entry into most of the attractive markets in the world, as all these markets have a data exclusivity policy, which prohibits a company from entering the market for a period of up to 11 years unless you have full registration package that was internally developed. It can also provide us with a durable patent protection product that can be marketed alongside other tapinarof formulations as well as monetized to potential partners. We are extremely committed to this project and have already dedicated resources to its advancement. Our first initiative has been to develop a GMP-compliant active pharmaceutical ingredient, or API, of tapinarof to meet FDA standards by partnering with a reputable API manufacturer, Wavelength Pharmaceuticals, which is well-known in the field for its stellar track record FDA GMP compliance. This is an important milestone for us, which remove a major hurdle to clinical trial development. We are now full steam ahead with both clinical projects. In summary, we're extremely galvanized by this turn of event and our stronger-than-ever strategic position. We have struck a deal with a leading global dermatology company to monetize our late-stage products in a way that preserves financial upside for the long term and conserves cash in the near term. This partnership also permits us to focus on scientific efforts on innovative, high-value products that will drive upside for our shareholders. We have also carefully mapped our regulatory and legal strategies, which are core competencies for Sol-Gel, alongside our formulation capabilities. Backed by our strong science innovation, it is our aim to be a leader in the topical dermatology field by the end of this decade. I will now turn the call to Gilad. Gilad? Thank you, Mori. At the end of May of this year, we had $42.1 million in cash investments. We estimate that our cash resources will enable funding of operational and capital expenditure requirements into the first quarter of 2023, assuming FDA approval of both TWYNEO and EPSOLAY in 2021. This estimate excludes any sales milestone or royalty payments that we may receive from Galderma. We now turn it over to the operator for Q&A. At this time, we'll be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary for you to pick up your handset before pressing the star keys. One moment while we poll for questions. Our first question comes from the line of Elliot Wilbur with Raymond James y ou may proceed with your question. Thanks. Good morning, good afternoon c ongratulations on the deal with Galderma and the progress on your pipeline. I guess my first question is with respect to the Galderma licensing agreement o bviously, it's the company to partner with in the dermatology space, clearly the leader in the category. They also have a lot of products. Can you just give us some sense of how the licensing agreement incorporates? or embeds various performance obligations in terms of sales and marketing spend or minimum level of details? How are TWYNEO and EPSOLAY going to be positioned against some of Galderma's existing products, mainly Epiduo Forte, Aklief, and Differin? Just curious as to how they're going to make room for these attractive assets within a fairly large derm portfolio. Let me answer it. We will start the answer, and then Gilad will follow. What we have to remember is right now, Galderma does not have so many products because both Epiduo and Soolantra, the two leading products that paid the bills for the last years are now genericized. It makes no sense to market it. Our two products came very sharp on the area where they are lacking. The new retinoid cannot become an alternative to Epiduo t hey're not perceived so in the market. The two products that we are offering are right, the products that they need t hey need a replacement for Soolantra, which was up to $200 million, and they got EPSOLAY, and they needed a replacement for Epiduo, and they got TWYNEO. That's why they were eager to have it and were excited about the opportunity. Because of this complementarity, we feel very confident that they will pursue this business because they can do it relatively easily because of the contacts and the lack of a competitive product in the very same category. That's what made this deal so valuable for both parties. For the specific numbers regarding sales minimum, we do not disclose the numbers, but certainly we took care of that also. Okay. I had a follow-up as well, unless Alon [Unintelligible] g ot additional commentary there? Yes, indeed l ovely. Could you repeat just the question, the follow-up question? Sure w ell, let me ask the follow-up question then. Just moving beyond the promotion and just looking at the rights to get back the products in five years, seems to be obviously quite an attractive option a ny financial payment associated with those rights in order to reacquire? No, there is no-. Products? -financial. We can get it back up to five years. Okay. We have the option to get it back up to five years. There is no cost to it. Okay. Just one last question here, and I'll get back in the queue. On roflumilast, you mentioned the regulatory pathway here and went into a lot of detail about how you're proceeding and using the 505(b)(1) pathway. Just wondering, the 505(b)(1) pathway versus the 505(b)(2), how much longer do you think that will take in terms of the development pathway? Just curious, obviously, the 505(b)(1) may circumvent some IP that's out there b ut, there's still the possibility of commencing litigation against the Sol-Gel formulation once the product is proved and commercialized i m just wondering how you were thinking about that alternative versus pursuing the 505(b)(2) w hich forces litigation at a much earlier point under Hatch-Waxman. Let me put things in order. The 505(b)(1) strategy is for tapinarof. In the case of roflumilast, we are going to use the 505(b)(2) route, only we will refer to the old product of roflumilast, so that also in this case, we'll avoid the part of our litigation. 505(b)(1) is tapinarof. Now you ask several good questions. We have already started the development of tapinarof, and it is our expectation to reach the market not later than five years from the launch of the brand. This means that if I take, for example, U.S., where practically if you have a new chemical entity, a pediatric exclusivity, and a 30-month period that starts about three months after you have submitted, because you have to write to them, and they have to write, sue you back, plus the appeal on appeal, it is rarely less than 10 years that one can maintain exclusivity when a company has a new chemical entity as tapinarof is. By resorting to a route that will require only five years from the launch of the brand, we are going to have five years of exclusivity in the U.S. marke n ow, if we assume that the market is between $500 million or $1 billion by 2028, roughly similar to roflumilast, we are talking about huge potential for ourselves, both as a brand and also as an unbranded product. We started discussions with companies, and everyone is very excited about this possibility so t he value is at least five years of exclusivity in the United States. Six or maybe more in Europe because there they have the 11 years of data exclusivity, if you will. We're talking about a huge benefit that will translate into $100 of $1 million. The cost will be higher, but in our models, again, which are based on the forecast of the analyst, and if they are right, we will reach break even very soon after launch, maybe two years or something. Now your question about patents. We study every patent of Dermavant and every patent of Arcutis very thoroughly w e have several legal advisors, and we are confident that our product will not infringe in any shape or form, the patents of each of these two companies l et's not talk about tapinarof. Yes, they can sue us, but we are not afraid from a sham suit if they don't come together with a 30-month stay. Any litigation will be a sham litigation. We are not afraid of sham litigations w e are worried about litigations that come with three, four, five years of stay. We are confident w e know the patents, we know the patent applications, we know the comments from the patent office. We are very confident, and so are our legal consultants, that we are not going to infringe any patent. Okay. Thank you. Appreciate the responses. Our next question comes from the line of Gary Nachman with BMO Capital Markets. You may proceed with your question. It's Evan Hua, filling in for Gary Nachman, c ongratulations on the partnership and the pipeline updates. My first question, I think you mentioned that SGT-310, you already filed NDA to the FDA? when do you expect to receive a potential approval for that product? No, SGT-310 was not there. None of the three products were filed, not at all. Okay. We submitted the NDA for EPSOLAY now, not for the product that are mentioned in our press release for the Albumin pipeline. SGT-210, SGT-310, SGT-510. Got it. Not yet submitted an NDA for them. Got it. Yeah. Thank you for clearing that up. I have another question regarding EPSOLAY. Has there been any updates regarding the pre-approval inspection for that facility? Has there been further discussions with the FDA around that? We approached the FDA, but we have not received any response yet regarding when and how they are going to conduct the pre-approval inspection. Got it. My last question, for SGT-150, can you provide some more color around the timeline to approval? When do you expect to meet with the FDA regarding the 505(b)(2) pathway for that product? Would you please repeat the number? SGT-510, you mean? Yes. Sorry. SGT-510. As I said, there are two routes and e ach route will have its own timeline. Our preferred route right now is to reference our product to the Formulas Oil brand. We will approach FDA, I guess, sometime beginning of Q4 2024. The first Pre-IND meeting in order to initiate safety study will take place in 2023 for the 505(b)(2). NDA submission is estimated to be submitted in 2026. Got it. Yep. Thank you. Ladies and gentlemen, we have reached the end of today's question and answer session. I would like to turn this call back over to Mr. Alon Seri-Levy for closing remarks. Thank you very much, operator. I would like to take the opportunity and to thank Sol-Gel's excellent employees for making the achievements we announced today feasible and to thank you all for joining us this morning. Thank you. Operator? Thank you for joining us today. This concludes today's conference. You may disconnect your lines at this time.