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Foamix Pharmaceuticals (NASDAQ:FOMX)
Q1 2019 Earnings Call
May. 08, 2019, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Greetings, and welcome to Foamix Pharmaceuticals first-quarter 2019 earnings call. [Operator instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host for today's call, Mr. Michael Wood with LifeSci Advisors.

Thank you. You may begin.

Michael Wood -- Investor Relations, LifeSci Advisors

Thank you, Rob. Good morning, everyone, and thank you for joining us on the call. Yesterday, Foamix issued a press release with earning results and a corporate update for the quarter ended March 31, 2019. Press release is available on the investor relations page of the Foamix corporate website, foamix.com.

This call is being recorded and webcast, and a replay will be available on the company's website for the next two weeks. Before we begin formal remarks, I want to remind you that some of the information in the news release and on this conference call contain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words that express and reflect optimism, satisfaction with current progress, prospects or projections, as well as words such as a believe, intend, expect, plan, anticipate and similar variations are all identified forward-looking statements, but their absence does not mean that a statement is not forward-looking. Such forward-looking statements are not a guarantee of performance, and the company's actual results could differ materially from those contained in such statements.

Several factors that could cause or contribute to such differences are described in detail in Foamix's filings with the securities and exchange commission. These forward-looking statements speak only as of today's press release and conference call, and the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the circumstances after the date of this call. Participating in today's call are Dave Domzalski, chief executive officer of Foamix; Ilan Hader, chief financial officer. And also participating in the Q&A session will be Dr.

Iain Stuart, chief scientific officer; and Matt Wiley, chief commercial officer. With that, I'll turn the call over to Dave Domzalski. Dave, please go ahead.

Dave Domzalski -- Chief Executive Officer

Thank you, Michael. Good morning, and thanks to everyone for joining our call. 2019, so far, has been a busy and productive year for Foamix with a number of major accomplishments. The NDA for our most advanced candidate, FMX101 for acne, has been accepted by the FDA, putting us on track for our first potential commercial approval in the United States in October of this year.

We are also planning to file a second NDA for FMX103 toward the middle of this year. In parallel, we continue to measuredly build our commercial infrastructure and invest in our sales and marketing capabilities as we prepare to launch our products in dermatology. Let me begin with FMX101, which we are developing for moderate-to-severe acne. On March 7, we announced that the FDA accepted our New Drug Application and has set October 20 of this year as the targeted PDUFA action date.

The NDA is being reviewed under the 505(b)(two) regulatory pathway. To date, our communications with the FDA continues to be fluid, and the review of our NDA is proceeding in line with expectations. The NDA is supported by a very comprehensive data package, including the previously communicated results from our two Phase 3 trials, studies FX2014-05 and FX2017-22. It also incorporates information on chemistry, manufacturing and controls and data from nonclinical toxicology studies on FMX101.

Our FMX101 product will also be the subject of 2 late-breaking poster presentations at the Annual Meeting of the Society for Investigative Dermatology, which is being held in Chicago this week. Our chief scientific officer, Dr. Iain Stuart, will be presenting this data. The first poster will provide an overview of the unique properties of FMX101 vehicle on beneficially impacting sebum viscosity and melting point at skin temperature.

The second poster summarizes a significant body of work characterizing the antimicrobial potency of minocycline against Cutibacterium acnes, or C. acnes, which is the key driver in inflammatory acne development. Our data suggest that minocycline continues to be a highly potent bacteriostatic agent against this bacterium, with very little antibiotic resistance liability being observed in our studies. FMX103, our 1.5% minocycline foam candidate for papulopustular rosacea, will be our second product candidate that we will file an NDA for, and we remain on schedule to submit our New Drug Application to the FDA around mid-year.

We're awaiting on the final clinical study reports from our Phase 3 program, and we also plan to hold a pre-NDA meeting with the FDA later this quarter, just prior to our NDA submission. In preparing this filing, we intend to leverage much of the work we have previously conducted for FMX101, given the similarities between these two products. The FMX103 filing is also supported by strong Phase 3 data. In February this year, we announced positive results from our long-term, open-label safety study, FX2016-13, that evaluated the safety of FMX103 therapy for up to an additional nine months of treatment beyond the 12 weeks in which patients were treated in our two registrational trials.

We discussed these results on our year-end earnings call, so I will refer you back to our press release from February 27 for the details of these study results. In parallel with the R&D and regulatory activities around FMX101 and FMX103, we are also making progress on the commercial front as we prepare to launch these products. These efforts are being led by Matt Wiley who became our Chief Commercial Officer last November. Key members of our commercial marketing, supply chain, managed care and medical affairs functions have come on board, and we have been moving swiftly in our prelaunch activities.

I'm quite pleased with the progress our team has made, and I look forward to providing more details on these activities over the next few quarters as we approach the PDUFA date in October and our planned launch for FMX101 at the turn of the new year. We believe, based on surrogate launches in acne, that the environment for novel branded entrants into the market is very favorable. The most recent launch, sarecycline, which is a tetracycline-derived oral antibiotic, is particularly interesting because of both its recency and positive market uptake. While the macro prescription trends in the category have remained relatively stable over the last few years, the early market uptake of sarecycline in 2019 demonstrates a continued unmet need in the treatment of acne and a desire for novel therapeutic options.

We have confidence that FMX101, with its unique product attributes and localized activity, if approved, will have distinct and favorable competitive advantages in this market and should fill these unmet market needs even further. At the R&D Day we hosted earlier in the year, we provided an update on a few of our pipeline products for the first time. The most advanced product is FCD105, which is our combination foam product of minocycline and adapalene for the treatment of acne. Adapalene is one of the most widely used retinoids for common nodal acne and is an active ingredient in the leading acne brands.

We believe combining adapalene with minocycline could present another significant advancement in topical therapy for acne patients. Plans are now at an advanced stage to initiate a Phase 2 study in the U.S., and our goal is to enroll the first patient by the end of the second quarter. As we have said, as we bring new and innovative products to the market, our goal is to address unmet needs of patients and healthcare providers while also creating long-term value for our shareholders. One of our key objectives to achieving this goal is to create durability around the acne and rosacea franchises.

We believe the development of a product like FCD105 behind FMX101 and FMX103, plus the earlier-stage programs we have in development, can provide new and potentially better options for patients and establish a substantial, profitable and sustainable business in these therapeutic areas. Finally, in February and in April of this year, we had two additional patents granted to support FMX101 and FMX103 that will be listed in the Orange Book. These are continuation patents to previously filed applications that should further consolidate our position and to provide competition claims of differing scope to support our products. With that, and at this point, I'd like to now turn the call over to Ilan Hader for a review of the financial results.

Ilan?

Ilan Hadar -- Chief Financial Officer

Thank you, Dave, and good morning, everyone. Our total revenues in the three months ended March 31st, 2019 was $308,000 compared to $906,000 in the three months ended March 31st, 2018. The decrease was due to reduced royalty payments from LEO Pharma to us for sales of Finacea foam and is the result of supply issues related to the Finacea foam product. LEO has informed us that they are working diligently to resolve the matter.

We do not view this decrease as material to our business, and it is important to note that the supply chain issue for Finacea is not related to the manufacturing, production or supply of any of our products, including FMX101 and FMX103. Our research and development expenses for the 3 months ended March 31, 2019 were $10.8 million, which were reduced significantly from the $22.8 million we reported in the first quarter of 2018, primarily as a result of lower clinical trial costs as the registration studies for FMX101 and FMX103 came to conclusion. This was offset by an increase in payroll-related and consulting expenses. General and administrative expenses for the three months ended March 31st, 2019 were $5.3 million compared to $3.8 million reported in the first quarter of 2018.

The increase year-over-year resulted primarily from an increase in expenses mostly relating to pre-commercialization activities and market research. In the three-month period ended March 31, 2019, we reported financial income of $504,000 compared to $73,000 in the comparable period of 2018. Our financial income includes mostly gains from marketable securities and interest earned on our bank's deposits. Our net loss for the three months ended March 31, 2019 was $15.2 million or $0.28 per share compared to $26 million or $0.69 per share in the first quarter of 2018, representing a decrease of $10.8 million or 42% year over year.

As of March 31st, 2019, Foamix had cash and cash equivalents of $82-point million compared to cash and cash equivalents of $99.4 million at December 31, 2018. Based on our cash flow forecast for 2019 and 2020, we believe that we have sufficient cash to support our operation until mid-2020. For further details on our financials, please refer to the Form 10-Q in the financial statement filed with the SEC yesterday. I will now hand the call back to Dave for closing remarks.

Dave Domzalski -- Chief Executive Officer

Thanks, Ilan. This is a very exciting time for Foamix with one product now under review at the FDA and preparations under way for a second NDA filing by mid year. I'm very pleased with our progress and the execution of our plans by the team here at Foamix. As we transition to commercialization, we see a great opportunity to serve the dermatology community, as well as create value for our shareholders.

Before I open the call for questions, just one reminder that we will be presenting at the Bank of America Merrill Lynch healthcare conference next Tuesday, May 14, in Las Vegas. Details of the presentation slot are on our website and we hope to see some of you there in person. The presentation will also be webcast. So with that, operator, we're now ready to take on some questions.

Questions & Answers:


Operator

[Operator instructions] Our first question comes from Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Sudan Loganathan -- Cantor Fitzgerald -- Analyst

Yes. Thank you. This is Sudan Loganathan in for Louise. I've got a few here.

So first, what are the future goals for the FCD105 asset? Since FMX101 is on track to launch for the treatment of acne vulgaris, what will be the difference in the indication or patient population for FCD105 treating acne vulgaris? And then, secondly, do you have any plans for ex-U.S. expansion for the FMX101 or 103 programs? And if so, will there be a partner? And how does the acne rosacea market differ? Or is it similar to the U.S.? When can we get details on this front? And then, thirdly, my last one, you've mentioned the plans expected to see a net planned price of approximately $200 to $400. What are the different factors going into the lower versus higher end of that range?

Dave Domzalski -- Chief Executive Officer

OK. Thanks, Sudan. So I'll take the question regarding ex-U.S. plans.

So as we've said for some time now, our focus is on the development of our products and commercialization of our products here in the United States. We're certainly open to partnerships outside of the United States, and we continue to have ongoing dialogue with different organizations regarding such in different regions around the world. Obviously, at this stage, nothing is imminent, but we do look at those opportunities. Those -- that dialogue or those discussions have certainly increased to quite an extent post our positive Phase 3 results about acne and rosacea toward the back end of last year.

So we'll continue to explore those opportunities, certainly, where it makes sense. Again, we're in dialogue with various potential partners. If we do engage in such partnerships, obviously, we'll be looking for those partners to lead the activities going forward. Regarding goals for FCD105, I'll turn it to Iain, Dr.

Stuart, to provide overview of the program itself and the differentiation, if you will, between this study and what we've done for FMX101. So Iain? 

Iain Stuart -- Chief Scientificf Officer -- Analyst

Sure, Dave. Thanks for your questions, Sudan. So in relation to differentiation, I'll just state on the call, this is a 505(b)(two) pathway for FMX101. So we anticipate to have comparable indication to a reference listed drug, which is SOLODYN.

So just to remind you, that's for the treatment of inflammatory lesions of nodular moderate-to-severe acne vulgaris. Anticipation for the corresponding indication for FCD105 is it will not be a qualifier as to the treatment of inflammatory lesions, it will be the treatment for the entire disease, which will include comedonal acne as well. So that's how the two of them differentiate in relation to indication, or at least anticipated indication. In relation to the Phase 2 study, so we've already communicated that this is a 4-arm study, FCD105 will be one arm.

Second arm will be 3% minocycline foam. The third arm will be zero-point-one -- sorry, 0.3% adapalene foam and vehicle. So this is a standard acne protocol here where we compare the many treatment activities in safety to the dyad, which is obviously the combination. It will be a 12-week study, very similar to many acne studies where patients will self-apply the product once a day.

Clearly, we'll be looking at our IGA treatment success and reduction of both inflammatory and noninflammatory or comedonal lesions and, of course, the standard safety assessments will be taken as well.

Dave Domzalski -- Chief Executive Officer

Thanks, Iain. Regarding, Sudan, your question on net price we plan, I'll turn it to Matt for some additional thoughts.

Matt Wiley -- Chief Commercial Officer -- Analyst

So as we think about the net planned range that was communicated in the last conference call, it's really predicated on a couple of different things. One is our market entry, pricing strategy and then our contracting strategy. That range is really going to then dictate whether the product is non-preferred, meaning tier two or perhaps tier three with a simple step edit or prior authorization. Again, it's going to be dependent on the pricing and contracting strategies.

So that's -- those decisions are yet to come.

Sudan Loganathan -- Cantor Fitzgerald -- Analyst

Ok. Great. Thank you.

Dave Domzalski -- Chief Executive Officer

Yeah.

Operator

Our next question comes from Vamil Divan with Credit Suisse. Please proceed with your question.

Inanc Caner -- Credit Suisse -- Analyst

This is Inanc Caner for Vamil. I know last quarter, you guys were sort of expecting to launch FMX101 shortly after the PDUFA. Right now, you sort of said that it's going to be early next year. So have there been any changes to your commercialization plan, timeline or strategy? And secondly, in terms of the Finacea foam payments, when can we sort of expect those to come back? And sort of should we expect them to continue in the $1 million range? And then, thirdly, could you talk a little bit about your R&D spend expectations for 2Q as you sort of enroll FCD105 and then also possibly submit the application for FMX103?

Dave Domzalski -- Chief Executive Officer

Sure. Regarding first the question on the launch of FMX101, nothing has changed at all. In fact, I've been quite clear and consistent in our communication. We have our anticipated PDUFA date, which is October 20 of this year.

We will -- we anticipate it will take a few weeks, assuming the product is approved, to actually load the trade. That obviously takes you right through the holiday season here in the United States. We would obviously look to get products through the trade and potentially book sales for the organization as early as the end of this year. But in terms of a formal launch with our sales force, that would likely take place right after the new year.

Not an ideal time to be launching products with a commercial infrastructure during the holiday season. That's really what we're looking at. So always been consistent, PDUFA date October 20th, a formal launch with the sales force right after the turn of the year. Regarding Finacea foam payments, as we outlined, we had a -- saw a decrease in the royalties, but we're talking hundreds of thousands of dollars.

We're not talking millions of dollars. So we do not view, and have not viewed that these payments from LEO, or previous to that payer, is material to our business. We identified or LEO informed us that there's a supply issue with the Finacea foam products. They're working to address it.

We have confidence that will get addressed as quickly as possible. And then when that happens, we would anticipate or hope to see a return to levels that we've seen previously. Last comment, again, I'll just reinforce, it's important to note that the supply just have absolutely nothing to do with the manufacturing, production or supply of our products and development of FMX101 and FMX103. Last, regarding R&D expenditures, as we outlined in our call, those costs, certainly for the quarter, have significantly been reduced since we've wrapped up the studies for 101 and 103.

We've not provided really any specific guidance on R&D costs for the balance of the year. We've been running at a burn rate of around $15 million or so per quarter. That's where we've been tracking at. We anticipate that our SG&A costs will continue to increase as we move toward launch.

And we have sufficient capital to get us through mid-2020 with the cash we have on hand.

Inanc Caner -- Credit Suisse -- Analyst

Great. Thank you very much.

Operator

Our next question comes from Stacy Ku with Cowen & Company. Please proceed with your question.

Stacy Ku -- Cowen and Company -- Analyst

Hi, good morning and congratulations on the progress. Thanks for taking my questions. So first, given the recent pricing pressures in the pharma world, we appreciate any insight into the current pricing decisions for FMX101 and potentially 103. Could you add some commentary around the payer appetite to reimburse for FMX101? And I have a follow-up.

Dave Domzalski -- Chief Executive Officer

Go ahead, Matt.

Matt Wiley -- Chief Commercial Officer -- Analyst

Sure. So you know the -- right now, the payer environment is changing, as you know. And so the landscape, because it is evolving, is going to require us to continue to monitor and do a pricing research -- another pricing research study closer to launch. So the decision on final price will be made very close to the PDUFA date.

As we know, the value proposition to payers is indicated that they do see a net planned range of $200 to $400, as we stated earlier. So we understand roughly what the payers are willing to pay given the clinical value proposition. And we'll continue to evaluate that as well between now and PDUFA, and that will feed into our final decision.

Stacy Ku -- Cowen and Company -- Analyst

OK. That's helpful. I'd also like to follow up with another question on the FMX101 launch. Can you add any additional commentary on the prelaunch activities? And importantly, can you help us understand the strategies in place to address the six-month lag in coverage?

Matt Wiley -- Chief Commercial Officer -- Analyst

Sure. So we're doing a lot of the traditional work now as it relates to market prep. So we want to condition the market specifically on the vehicle technology, some of that's being done through medical affairs activities. Some of that will be done through commercial activity as well in an unbranded format.

As it relates to the three-to-nine-month lag in coverage. So first of all, we will have our PDUFA date on October 20th. That'll give us some time before commercialization to begin to speak with payers and hopefully get to P&T review. As it relates to the balance of that time, we believe that we will have to use some synthetic coverage to help patients access the drug until we do have payer coverage.

Dave Domzalski -- Chief Executive Officer

Yes. I would -- this is Dave. I would additionally add that in terms of our prelaunch activities, I'm thrilled with the effort from the team here. We have our key functional positions in place, have already been engaged with the various partners, if you will, and audiences.

We've had ongoing market research, really good feedback on the market research about the prospects for our product, if approved. As I alluded to in my opening, formal comments, when we see what happened in the category itself with a product such as sarecycline, a drug which is an oral antibiotic, and see the uptake of prescription trends for that, we're even more bullish about the prospects for our product, FMX101. So when we look at the environment and the uptake of recent new products, couple that with the fact that there aren't a lot of competitors out there, and less ease, I guess, for share of voice and less mind share to compete against, quite bullish about our prospects to see a successful uptake of our drug once it's approved -- assuming it's approved.

Stacy Ku -- Cowen and Company -- Analyst

OK. Great. Thank you.

Dave Domzalski -- Chief Executive Officer

You're welcome.

Operator

Our next question comes from Jason Gerberry with Bank of America. Please proceed with your question.

Unknown Analyst

Oh, hi, good morning, everyone. This is Chi Young for Jason. A couple of questions from me. First going back to the robust launch of Seysara oral tetracycline and the net pricing range, given the value proposition of 101 being a foam version of minocycline, do you see sort of a pricing premium relative to where Seysara may be coming at net price basis? And secondly, can you comment a little bit about the FDA pre-approval inspection? I noticed that on the 10-Q, we noticed some minor inspection observations that are being addressed.

Doesn't seem like a major impediment of any kind, but if you can provide any color on what these inspections are, whether they are pretty common for an NDA review and maybe a timeline on when we can expect an update on that that would be great. Thanks.

Dave Domzalski -- Chief Executive Officer

Matt's going to take the first part.

Matt Wiley -- Chief Commercial Officer -- Analyst

So on the question of sarecycline, so that product is launched in the market with a WAC of $860, which is a premium to many of the products on the market, a discount to some of the branded antibiotics. We have to see -- and we have the advantage of examining the payer reaction to that price and what the market access strategy will be as far as contracting and net plans. So we do have some good visibility as we're evaluating our pricing strategy. It's not an intuitive strategy to price into a Tier four type of WAC position.

And so we're continuing to monitor, and we'll make that determination later in the year.

Dave Domzalski -- Chief Executive Officer

Thanks, Matt. And Chi, regarding the NDA review and the inspection process from the FDA, as I alluded to in my opening comments, we're pleased with the progress. Things continue to progress in line with our expectations. Regarding our comments in our 10-Q, these were just a few operational observations, not uncommon commentary during the process.

It's just that, not uncommon. The observations that were provided, much of which we had already addressed and provided the appropriate feedback to the FDA or in the process to do that. So we do not believe anything that has any material impact at all to the continued review of our NDA.

Unknown Analyst

Thank you.

Dave Domzalski -- Chief Executive Officer

You're welcome.

Operator

Our next question comes from Ram Selvaraju with H.C. Wainwright. Please proceed with your question.

Edward Marks -- H.C. Wainwright -- Analyst

This is Edward Marks on for Ram. A couple of questions. You mentioned that there's a lot of work going into the 101 launch from a commercial perspective. Wondering how much overlap there is with 103, whether you're communicating currently, whether you're undertaking any sort of commercial endeavors with 103 yet, or whether you're going to wait closer to maybe a potential PDUFA.

Dave Domzalski -- Chief Executive Officer

Edward, so one of the things that's nice, as we've often said, for the launch of these two products is it is the same active minocycline, different concentrations, different indications. So we view these products as distinct and unique. But in the same breath, we will be able to leverage very much or most of the infrastructure that we have or are in the process of putting in place for the FMX101 launch. So we'll have distinct strategies behind the launches, distinct materials for the launches.

They are two different indications. But we get to leverage very much the infrastructure, and the spend to support those launches. So they'll have -- they'll obviously have unique activities behind it. There will be some incremental spend when we get ready to launch FMX103.

But as I've often said, it's not as if we are launching to two different target audiences, need to build out to two different infrastructure, need to build out different teams. We get to leverage very much what we have done for FMX101. I'll turn it to Matt to provide some additional commentary on more of the specifics, to the extent that he wants to.

Matt Wiley -- Chief Commercial Officer -- Analyst

Sure. So the process that we get to a strategic plan and our final launch strategy, we've kicked that off already. We've developed our situation analysis, etc., and we're putting that strategic plan together. Some of the things that we're doing concurrently with the FMX101 launch such as contracting strategy, pricing strategy, sales force sizing, that's all being done concurrently.

Those things do have a knock-on effect for one another. So we make sure that those things are tightly defined now, so we don't have any potential issues down the road. And so that's -- those are the types of things that we're focused on in 103 today. But because we have a little bit more time, we are basically taking the same approach that we took beginning last November with 101 and going through the process of truly examining the market and the upside opportunities in it.

Edward Marks -- H.C. Wainwright -- Analyst

OK. That makes sense. And from the 101 NDA filing perspective, just wondering if you've received any, something like a multidisciplinary review letter from the FDA currently?

Dave Domzalski -- Chief Executive Officer

Regarding the review of the NDA, we anticipate that we'll have a mid-cycle review sometime toward the middle of the year, a late-cycle review toward the end of the year. And assuming all goes well, we'll be looking at label negotiations as we get into the third quarter, which is really standard process for NDA reviews.

Edward Marks -- H.C. Wainwright -- Analyst

And finally, considering the conferences starting this week, just wondering what you think some of the most important information you guys will be presenting at the investigative dermatology meeting is?

Dave Domzalski -- Chief Executive Officer

Yeah. I'll turn that to Iain since he's presenting at that meeting. Go ahead, Iain.

Iain Stuart -- Chief Scientificf Officer -- Analyst

So yeah, thanks for the question. So as Dave said at the top of the call, we are presenting two posters this week. I'm actually in Chicago tonight. The first one really is touching to the uniqueness of the vehicle, topical vehicle for FMX101 and its very beneficial impact on the viscosity and flow, if you will, on sebum, which is obviously a major component on the pathogenesis of acne.

So this really does underline this uniqueness of our vehicle and really is very different from anything else in the market. The second one is really establishing or reestablishing our understanding of the potency of minocycline against the target microbe, Cutibacterium acnes. As you know, that's the primary initiator of inflammatory acne. Minocycline has been in the market for many, many years and there's always concern in antibiotic use over this large period of time on resistance development or drug failure.

In our studies, we showed this potency is still very, very high, and that the resistance liability that we see in our studies is very, very low. Again, it's the unique data set for the molecule of tetracycline class, and again, very differentiating from all of the tetracyclines and antibiotics that are being used in this space. So those are the two posters that we're doing this week.

Edward Marks -- H.C. Wainwright -- Analyst

Perfect. That's all for me. Thank you for taking my questions.

Matt Wiley -- Chief Commercial Officer -- Analyst

Thanks, Edward.

Operator

Our next question comes from Patrick Dolezal with LifeSci Capital. Please proceed with your question.

Patrick Dolezal -- LifeSci Capital -- Analyst

I was just curious if there's any major differences in the payer views on reimbursement for products in the acne space versus rosacea, or if payers typically view these two indications in a similar light? And how might pricing differ for 101 versus 103?

Matt Wiley -- Chief Commercial Officer -- Analyst

So on the question of major differences, as we've done our landscape analysis, we don't see any true distinction between how the payers are viewing 101 and 103. And so more to come on that. We're doing a full landscape study on 103. And so if anything turns up, we would believe that the value proposition is going to be similar for 103 and be received that way.

The question on pricing differential, our operating assumption is that we will be pricing on a per mg basis. So there shouldn't be any difference in our price.

Patrick Dolezal -- LifeSci Capital -- Analyst

OK. Thanks. And could you just provide an update on the status of the FMX109 study and if there's any guidance on the timing of data?

Dave Domzalski -- Chief Executive Officer

Iain, do you want to take that? Iain, did we lose you?

Iain Stuart -- Chief Scientificf Officer -- Analyst

Sorry about that. Sorry. My phone just lagged a second there. Yes.

Sure. The guidance on the study, we're enrolling this study right now. We still have hope to have top-line results in Q3 of this year. Running concurrently with this study is our formulation development work as well.

So we hope to provide some additional guidance in Q3.

Patrick Dolezal -- LifeSci Capital -- Analyst

Great. Thank you.

Operator

Ladies and gentlemen, we've reached the end of the question-and-answer session. At this time, I'd like to turn the call back to management for closing comments.

Dave Domzalski -- Chief Executive Officer

Well, thank you. And again, thanks to everyone for taking the time out of your busy schedules. As I shared, it's been an exciting time for Foamix, off to a very strong start. And I look forward to providing everyone with updates over the course of the next several quarters.

Thanks. And we look forward to speaking with you soon.

Operator

[Operator signoff]

Duration: 38 minutes

Call participants:

Michael Wood -- Investor Relations, LifeSci Advisors

Dave Domzalski -- Chief Executive Officer

Ilan Hadar -- Chief Financial Officer

Sudan Loganathan -- Cantor Fitzgerald -- Analyst

Iain Stuart -- Chief Scientificf Officer -- Analyst

Matt Wiley -- Chief Commercial Officer -- Analyst

Inanc Caner -- Credit Suisse -- Analyst

Stacy Ku -- Cowen and Company -- Analyst

Unknown Analyst

Edward Marks -- H.C. Wainwright -- Analyst

Patrick Dolezal -- LifeSci Capital -- Analyst

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