Amphastar Pharmaceuticals Inc (AMPH) Q3 2020 Earnings Call Transcript

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Amphastar Pharmaceuticals Inc (NASDAQ:AMPH)
Q3 2020 Earnings Call
Nov 6, 2020, 12:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen, and welcome to the Amphastar Third Quarter Earnings Call.

[Operator Instructions]

All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements. Including among other things, statements relating to the company’s expectations regarding future financial performance, backlogs, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events, such as the impact of the COVID-19 pandemic and related responses of business and governments to the pandemic on our operations and personnel, and on commercial activity and demand across our business operations and results of operations. These statements are not historical facts but rather are based on Amphastar’s historical performance and its current expectations, estimates, and projections regarding Amphastar’s business, operations, and other similar or related factors.

Words such as may, might, will, could, would, should, anticipate, predict, potential, continue, expect, intend, plan, project, believe, estimate, and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar’s filings with the Securities and Exchange Commission, including in the Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 16, 2020. In particular, the extent of COVID-19’s impact on our business will depend on several factors, including the severity, duration and extent of the pandemic, as well as actions taken by governments, businesses, and consumers in response to the pandemic, all of which continue to evolve and remain uncertain at this time. You can locate these reports through the company’s website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov.

The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar’s expectations to change.

I would now like to turn the conference over to your host, Mr. Dan Dischner, Vice President of Corporate Communications. Please go ahead, sir.

Dan DischnerVice President of Corporate Communications

Thank you, operator and good morning everyone. Welcome to Amphastar’s third quarter earnings call.

My name is Dan Dischner, VP of Corporate Communications. Joining me on the call are Bill Peters, CFO, and Tony Marrs Senior Vice President of Regulatory Affairs and Clinical Operations. We appreciate everyone joining us today and we look forward to sharing some of our very exciting pipeline updates, how well Primatene has trended and other great news.

I would like to first start by sharing the exciting pipeline updates I just mentioned. I am pleased to announce our intranasal epinephrine, an NDA that will target the epinephrine auto-injector market. Thus far our intranasal epinephrine product has completed its Phase I clinical trial and we plan to begin Phase II clinical trials in the first quarter of 2021. While we usually do not discuss Phase I clinical trial results, I’d like to share that we believe our novel formulation of epinephrine significantly increases drug absorption rate while using and intranasal route of delivery for anaphylaxis treatment. This offers a very attractive and non-invasive delivery option compared to the currently marketed epinephrine products, that being of course as an intramuscular injection with auto-injector. We are excited about the potential opportunity this brings to strengthen our portfolio and provide a new treatment option for patients having an anaphylactic reaction. For epinephrine auto-injectors, the 2020 IQVIA Data Annualized Sales has an addressable market of over $4 billion.

Moving on to business. Our third quarter saw sales growth of 4% compared to the same period in 2019. Net revenues in Q3 compared to the prior quarter, saw a decrease of 3%. We are attributing primarily due to the impact of our IMS product portfolio, which previously had benefited from market shortages. And the third quarter saw lower demand due to the market shortage resolution. Regarding Primatene Mist, we continued to see progressive growth on this product due to our recent Kroger store launch and our nationwide TV, radio and digital marketing campaigns. We will soon publish an updated presentation on our website where you can observe that Primatene still presents a strong growth trajectory as the product has seen sales growth of 4% compared to the previous quarter.

We have great confidence in our abilities to continue to grow Primatene, therefore our ad spend for Primatene will increase by 20%, or to put it in dollar terms, in the range of an additional $1 million to $2 million on an annualized basis. Moreover, I’m pleased to announce that we are working on adding an additional distribution point for Primatene Mist with a nationwide mass marketing retailer, which we anticipate to launch sometime in the first or second quarter of 2021. We will continue to explore other opportunities in large retail chains. And on a final note on Primatene, I’d like to announce that we’ll be investing in a new TV commercial. We also will invest in digital media to broaden our market reach in the 18 to 34-year-old demographic. We continue to reiterate our guidance for Primatene, which is expected to reach prior peak sales of $65 million annualized next year in 2021. As we advance, we continue to expect our marketing spend to be a lower percentage of sales.

Regarding our recently launched epinephrine multi-dose vial product, Q3 has demonstrated that this product still benefits from its 180 days of market exclusivity as we still make our reintroduction into this market. Demonstrating this, our epinephrine multi-dose vial saw incremental growth by 7% compared to the previous quarter. We previously stated that we want to be competitive in this market without severely disrupting it and the goal has been going as planned.

With our AMP 001 product, we were given a GDUFA target action date for the third quarter of this year, or the fourth quarter if another pre-approval inspection was needed. We want to disclose that we are still awaiting a decision from the agency as they have not postponed the GDUFA date. However, the action date was not met. While AMP 001 is still in the same review cycle, we continue to maintain a positive dialog with the agency and are still excited about AMP 001 as it is still on track to become the first generic to hit the market.

Regarding AMP 002’s projections, we remain confident that the agency will find it to be therapeutically equivalent and continue to anticipate a fourth quarter the GDUFA target action date. Although news about AMP 001 may temper AMP 002 status expectations, our GDUFA date is still in the fourth quarter. We will keep you updated if we hear a response regarding the product’s progress with the agency as needed.

Regarding our China facility in Nanjing, otherwise known as ANP, it continues to advance toward completing construction of its finished pharmaceutical product facility and then eventually for a finished product launch for the Chinese domestic market. Regarding an update on a timeline toward completion, we’ll provide one as we approach closer to the date in the future. On a similar note to our international efforts, we continue to progress on our IMS UK products launch and anticipate our first launch in early 2021. We currently have multiple products on file and are working through the approval process.

Next, I’d like to bring up our insulin programs. We have made progress on our insulin biosimilar products specifically in the characterization and clinical stage. And our final pipeline item I’d like to bring up is intranasal naloxone. We remain our guidance for refiling intranasal naloxone in 2021.

On another note, I’d like to talk about enoxaparin briefly. Although there have been exits and a new entrant into the enoxaparin market, we have a long-term commitment to this product and this product has shown some improvements, seeing a 22% increase compared to the same period in 2019 and a 14% increase compared to the previous quarter attributing this to a greater market opportunity presented just recently. We are confident that our quality systems will prove to be the difference as our long-standing experience in this area, since we are the only company that manufactures both enoxaparin’s API and finished product in the United States.

Finally, we continued to see success in our pipeline development as demonstrated by our intranasal epinephrine product’s progress. We remain committed to the prospects of AMP 001 and 002 while we anticipate Primatene sales to trend upward as we approach allergy season. Although factors outside of Amphastar’s control may have tempered some expectations for now, we want to assure everyone that our success is made organically and is demonstrated by our R&D scientific and technical progress, especially regarding intranasal epinephrine and the proprietary formulation technology of this product. We are confident that our pipeline development will continue to demonstrate our technical capabilities.

I will now turn the call over to our CFO, Bill Peters, to discuss our third quarter’s financials.

Bill PetersChief Financial Officer, Treasurer, and Senior Vice President of Finance

Thank you, Dan.

Sales for the third quarter increased 4% to $83.4 million from $80.1 million in the previous year’s period. Primatene Mist saw sales growth of 255% to $13 million, from $3.7 million in the third quarter of last year, with strong sales to our current customers, growing online sales at Amazon.com, as well as the launching of Primatene Mist at Kroger, which is one of the largest grocery chains in the country. Enoxaparin sales increased 22% to $11.6 million from $9.6 million as Teva the enoxaparin market. Epinephrine multi-dose vial sales of $2.8 million in the second [Phonetic] quarter back on the market. Other finished pharmaceutical products, sales decline of $4.1 million as a competitor, who had previously had supply issues, returned to the market. Our insulin API business had sales of $2.1 million, down from $4 million last year as last year’s sales numbers included a $1.5 million amendment fee for MannKind.

Cost of revenues increased to $46.9 million from $44.9 million. Gross margins were relatively unchanged at 44% of revenues. We had increased margins related to newer higher margin products such as Primatene Mist and epinephrine multi-dose vials, which were offset by lower sales of naloxone and other finished pharmaceutical products. Selling, distribution and marketing expenses increased 14% to $3.7 million from $3.2 million due to advertising and distribution costs including television commercials for Primatene Mist. General and administrative spending increased 6% to $11.7 million from $11 million due to higher legal expenses. Research and development expenditures decreased 5% to $17.6 million from $18.6 million as lower expenses in China were partially offset by increased costs related to our biosimilar insulin program, our generic inhalation program and our newly disclosed intranasal epinephrine product.

The company reported net income attributable to Amphastar shareholders of $3.9 million or $0.08 per share in the second [Phonetic] quarter, compared to net income of $1.3 million or $0.03 per share in the third quarter of 2019. The company reported an adjusted net income of $7.6 million or $0.15 per share compared to an adjusted net income of $5.2 million or $0.10 per share in the third quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets and one-time events.

In the third quarter, we had cash flow from operations of approximately $8.8 million as we reduced inventory and accounts receivable levels. During the quarter, we used a portion of our cash to buy back approximately $4.3 million of stock.

I will now turn the call back over to Dan.

Dan DischnerVice President of Corporate Communications

Yes. Operator, we’re ready for the Q&A.

Questions and Answers:

Operator

[Operator Instructions]

Our first question comes from Jacob Hughes of Wells Fargo Securities. Your line is open.

Jacob HughesWells Fargo Securities — Analyst

Hey, thanks for taking the question. I wonder if you could just comment on the trends for Primatene in the quarter. It looks like the growth slowed a bit sequentially. And we had the leveling off in the pantry load in the beginning of the year. I think you launched Kroger at the beginning of the quarter. So, if you could just touch on how that’s going? If there is any other retailers you could launch in? And how you’re thinking about the upside to the $65 million annual sales target?

Dan DischnerVice President of Corporate Communications

Sure. Great. Yeah, we still — Primatene is still — the trajectory is still good. There might have been some slow because of the pantry loading, as we’ve talked about in the past, but we still feel like the trajectory has kind of return to what we expected it to be. Kroger — introducing at the Kroger has gone really well. We see that there. Amazon has been doing well, as well. Even though, we still believe that this product is more — in the physical stores, has — we’ve seen it better there, but we do believe Amazon will continue to be an important component of it. We are planning, we’re hoping to launch in the first or second quarter of next year, into a major retailer. So we hope that will also help this there, with the growth of the sales. And as we said, we believe that the advertising campaign that we’ve done with the commercials — adding a new commercial. We believe that that’s really going to help us, and we believe that — those peak sales of $65 million that we had previously, we believe we can get back to there really easy.

Bill PetersChief Financial Officer, Treasurer, and Senior Vice President of Finance

Yeah. And just a couple more points. One is that we are updating the slide on the — that shows the in-store sales levels to our investor presentation. If it’s not out there now, it will be by the end of the day. Additionally, Kroger — earlier in the quarter — actually it wasn’t earlier in the quarter, it’s actually late in the quarter. So while we did have some load in sales to Kroger, they did not have the opportunity to put in reorders during the quarter as well.

Jacob HughesWells Fargo Securities — Analyst

Got it. That’s helpful. And then just on 001, maybe you could comment what’s causing the delay with the FDA? Thanks.

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Yeah, hi, this is Tony. We don’t really see anything that’s triggering a delay. It’s not as though we’re going through cycles with the agency. Right now we are in routine communication with the agency essentially just getting kind of routine updates. What they’re telling us is just that they have not met their action date. So we’re not really clear, we just expect it’s part of their normal review cycle for a complex product like this.

Jacob HughesWells Fargo Securities — Analyst

Thanks a lot, guys.

Operator

[Indecipherable] BMO Capital Markets. Your line is open.

Dan DischnerVice President of Corporate Communications

Good morning, Gary. You there?

Rafay SardarBMO Capital Markets — Analyst

Can you hear me?

Dan DischnerVice President of Corporate Communications

There you are. Are you there? Hello? Operator, we don’t hear anything on our end.

Operator

One moment, sir.

Dan DischnerVice President of Corporate Communications

Operator, can we just move to the next question?

Operator

Mr. Gary Nachman, your line is now open.

Rafay SardarBMO Capital Markets — Analyst

Hi there. Can you hear me?

Dan DischnerVice President of Corporate Communications

Yes. There we go.

Rafay SardarBMO Capital Markets — Analyst

Great. I don’t know what happened there. But it’s Rafay Sardar on for Gary. Regarding the intranasal epinephrine opportunity, I’m curious how long do you expect it would take to run the Phase II trial and what additional studies will be required after that.

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Yeah, hi, this is Tony, again. We’ve been working pretty closely with the agency on this product. What I can say is we’re very encouraged from some of the comments that we’ve received from the agency. They’re very, very positive, they’re very clear on what the expectations are. As Dan said, we’ve completed our Phase I. The results are very promising. The PK profile is very encouraging. And we’re planning to go into the Phase II trials very shortly thereafter. Rather than get into the complexities and the scale of the trials, what I could say is that broadly if things go according to our plans, we would anticipate to be filing this application sometime in 2022.

Rafay SardarBMO Capital Markets — Analyst

Thanks. And then I was also hoping you could comment on gross margin heading into 2021. I know there is an incremental benefit in 2020 for Primatene that won’t reoccur. So, just any color there would be helpful. Thank you.

Dan DischnerVice President of Corporate Communications

Yeah. So while we did have the issue with Primatene where we had expensed many of the components that were purchased prior to the approval and that did help the gross margins last year and this year, we’ve burned through those components. We’re still using API, which had been expensed prior to launch. But that’s becoming a smaller and smaller amounts of the cost of goods. However, the Primatene Mist is still going to be growing next year. And because of that, we’ll will have higher sales of a product that is well above our corporate average. So that will help the gross margins in general. Also, the products that we expect to be on the market next year, AMP 001 and AMP 002, should have higher gross margins than our corporate average as well. So we think that those trends will help us increase our gross margins next year.

Rafay SardarBMO Capital Markets — Analyst

Thank you.

Operator

Our next question comes from Tim Chiang of Northland Capital. Your line is open.

Tim ChiangNorthland Capital — Analyst

Hi, thanks. It looks like your third quarter came in a little short versus expectations, at least consensus expectations. I’m sort of wondering if some of the revenue that we thought you were going to get in the third quarter might be shifting into the fourth quarter or even the first or second quarter of next year. Obviously, you’re still waiting for over 001, maybe 002, but what do you guys think the likelihood is that these product approvals really shift into 2021?

Dan DischnerVice President of Corporate Communications

Yeah. So the first thing there, Tim, is that we — there is definitely always timing. Some of these things are one-time things, some are just timing with the other finished pharmaceutical products. We did mention that we did have a competitive return to the market. So that was what was causing the sales decline there and that should continue in the future. But things like Primatene are very strong and we expect growth in that product definitely into the fourth — in the fourth quarter and well into next year as we still are talking about $65 million as our sales target for next year. And on AMP 001 and 002, at this point in the approval cycle, since we don’t have approval today, I would say that it’s unlikely that we would have any material sales from either of those products in 2020.

Tim ChiangNorthland Capital — Analyst

Okay. And then could you talk a little bit about just the epinephrine multi vial injection product? How is that doing in the hospital market? I know you — basically, the first generic into that market. Were there other competitors have entered?

Dan DischnerVice President of Corporate Communications

No, we’re the only one. So we have a six-month exclusivity. So happy about to be in that position. We are gaining market share and the sales last quarter were primary load into the wholesalers and the sales of this year, which were higher than last quarter, were restocking and indicate the actual sales levels that we have now. Our sales — our market share grew over the course of the quarter. So we think that that product will also continue to grow sales, as we look into the fourth quarter next year as well.

Tim ChiangNorthland Capital — Analyst

Okay. And then maybe just one last question on this intranasal epinephrine. Given the Phase I data that you have, what’s your plan in 2021? Are you going to need — what additional studies will you need to run? I am assuming you’ve met with the FDA recently, or you plan on meeting with them to sort of discuss what other clinical studies you’d have to run here?

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Yeah, hi, this is Tony. We have had correspondence with the agency. We have an IND that we filed with them. They’ve seen our clinical plan and gone through it. 2021 will have a number of trials that we’ll be performing. We have a pretty good grasp of what those trials are. They’re types of trials that we’ve done before. We’re familiar with doing intranasal type trials. We’re familiar with epinephrine and doing trials with epinephrine. So I think 2021 is where the bulk of our trials will be completed. There’ll be Phase II and Phase III trials that will be performed during that time. But the emphasis is, we’ve been working with the agency on it and they’re really — the comments that we’ve received from the agency on this have been very positive. I really want to emphasize that. It seems they’re very hungry for a product like this. Some of the strengths that we have for this product, I think they’ve been able to see, we really have created a special enhancement agent that we’re going to be using with this that really will give us good differentiation in our product. We’ll have a superior product that will be used for the consumers and we’re very encouraged by that. And we think the agency is as well.

Tim ChiangNorthland Capital — Analyst

Okay. Great. Thanks.

Dan DischnerVice President of Corporate Communications

Thank you.

Operator

Our next question comes from David Amsellem of Piper Sandler. Your line is open.

David AmsellemPiper Sandler — Analyst

Hey. Thanks. So on the two injectable pipeline products, 001 and 002, I may have missed this, but have you said or can you say whether you’ve had pre-approval inspections for one or both of these products? That’s number one. And then number two is, on the market shortages, I think you had cited potential — I forget what the figure was, but some potential revenue benefit from the market shortages. So can you talk through what resolved, what hasn’t been resolved and what you think — what kind of benefit, if any, you can derive from any market shortages going forward? Thanks.

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Yeah, hi. I can speak to the pre-approval inspection for these two products, AMP 001 and 002. We previously disclosed that we’ve had inspections for both of these. AMP 002 in particular is the most recent set and these were very rigorous inspections were they inspected every possible facility or component of our operations, including manufacturing, our clinical site where these trials have been performed and the laboratories where the analysis has been done. So those were very positive, and overall, we don’t anticipate to have additional inspections associated with these. The results were positive for all of those.

Dan DischnerVice President of Corporate Communications

And your second question related to the shortages. There were multiple shortages in many of our critical care products that are on the hospital crash carts, includes product like dextrose, sodium bicarbonate, epinephrine. So a lot of these products had — we had a competitor, who was frequently out of the market. That competitor was shipping it seemed like for most of the quarter and — or near the end of the quarter. So we did not have the same level of sales because of their return to the market. They’ve had multiple outages and shortages over the last 10 years and we really can’t predict whether they will or will not be able to satisfy the demand that’s out there for these products. But we do know that we have the ability to as you that and we have the increased capacity that we put on earlier this year. So, we do have the capacity in the ability to meet demand should they have shortages.

David AmsellemPiper Sandler — Analyst

Okay, great. Thanks, guys.

Operator

Our next question comes from Elliot Wilbur of Raymond James. Your line is open.

Elliot WilburRaymond James — Analyst

Thanks, good morning. Just — the first question I wanted to ask was around the intranasal epinephrine development program. I’m presuming the path to approval is via a BE [Phonetic] study versus injectable epinephrine, but just wanted to ask you to confirm if that’s the case.

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

While we’re doing — the route of approval is the NDA through the 505(b)(2) route. So I wouldn’t quite call it a BE. And so, we’re not comparing it to just a general epinephrine injection. We’ll be looking at the intramuscular EpiPen type of device, as far as what will be comparing it to.

Elliot WilburRaymond James — Analyst

Okay. So I guess — still trying to [Indecipherable] is this a PK-based study or is it — or do they actually — I mean, there is not endpoints in studies like this. That’s impossible. But I’m just trying to get a little bit better sense of what has to happen given sort of the relatively short timeline that you have outlined in terms of potential filing?

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

I want to be careful about not disclosing too much. What I will say is, it’s — there is a strong PK component to it. Maybe that will give you enough.

Elliot WilburRaymond James — Analyst

Okay. And is this an internally developed program, or is it partnered?

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

No, this is part of the capabilities that we have. This was completely developed internally. Our scientists here came up with the concept and what they’ve done is pretty extraordinary. And as we get closer, and we’ll be able to disclose a little more about it, you’ll get a sense for some of that. It is something that we have IP that we have filed for. And once that comes to light, I think you’ll get a real good sense of what we’re trying to do. But essentially, we’re using a special enhancement excipient to assist in the absorption of the epinephrine. And once you see what that is and how we’re doing, I think it’s going to really, it’s going to be clear how advantageous this product will be.

Elliot WilburRaymond James — Analyst

Okay. Thanks for that. And I just want to ask a question on enoxaparin trends in the quarter. You may have addressed this in your prepared commentary. I apologize, I got a little bit late here. But in terms of the incremental step up, we’ve seen this in the past basically, when you’ve had the opportunity to kind of go after off contract sales on a short-term basis. It doesn’t seem like that’s the case, in terms of what drove the upside this quarter. Just trying to get a sense of how — how sustainable this increase is?

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Yeah. So it’s not off contract sales. Basically when Teva left the market, there were some — we were able to gather a portion of what they had. So hopefully, our sales level can stay at this level. But this market has seen a lot of twists and turns. But as Dan did say in his prepared remarks, we’re — this is a product that we’re in for the long term. And we make the API, we make the finished product, both here in the US and we’re very confident about our prospects for this product as a long-term generator of value for us.

Elliot WilburRaymond James — Analyst

So speaking on the lines — along the lines of long-term value generation, with Teva leaving the market, any chance that this product starts behaving more like to biosimilar that it is rather than a commodity generic in terms of pricing?

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

That’s our hope. But we haven’t necessarily seen that yet.

Elliot WilburRaymond James — Analyst

Okay, fair enough. Just real quickly on Primatene. Haven’t seen the updated slide deck yet to get kind of the latest data in terms of sort of the uptake here, but any other metric that you could share with us in terms of how many stores the product is on the shelf on? And I guess in terms of some of the early launch sites, kind of what you’re seeing in terms of pull-through per week, I guess sort of how we look at that?

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Yeah, I think we’re — it’s been every — everywhere we launched the product, it’s been well received. And so, we feel like — we’ve recently launched in Kroger, that was toward the end of the quarter. We expect that to do well. We’re really close to being able to add another large retailer to our distribution points. And so, we believe that that will also be a big thing. And we continue to invest in the advertising because we do see a very positive trend when we — with our advertising both television and digital media. And I think with our digital media, we’re really going to target kind of the 18 to 34 demographic and expand that market. So, we’re excited to see how that — how it’s received in that group.

Dan DischnerVice President of Corporate Communications

And just the chart that will be on the investor slide, it does show continued upward growth in the weekly sales. It will say that.

Elliot WilburRaymond James — Analyst

Okay. And just last question. You are ANDA filer on vasopressin, been in a lot of discussion about that product in financial markets as of late given that we’re approaching a trial date for a group of filers, as well as the possibility that Eagle [Phonetic] may in fact not have a blocking exclusivity position and is also suggested it may be in a position to launch at-risk. Just any updated developments or thoughts on your filing with respect to some of these recent emerging facts would be helpful. Thanks.

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Sure. So we’ll be — it will be in our 10-Q, which we hope to get filed by the end of the day today, but we did settle during the quarter and that settlement is confidential and it would be typical to other settlements that you’ve seen in these cases where there are multiple filers. So that’s all we can really say at this point.

Elliot WilburRaymond James — Analyst

Okay, good. Thank you.

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Have a good day.

Operator

Our next question comes from Serge Belanger of Needham. Your line is open.

Serge BelangerNeedham & Company, LLC — Analyst

Hey, good afternoon. A couple of questions on the epinephrine opportunity here. I guess the first one is once you’re 180-day exclusivity expires. How many generics. Do you expect to enter the market? And then just more broadly, how big is this market, and as you think of your new epinephrine product in development, what kind of role do you think it could play in this epinephrine market?

Bill PetersChief Financial Officer, Treasurer, and Senior Vice President of Finance

Yeah, OK. So, the size of the market, I do know it’s currently over $100 million dollars and size. And so, we–we expect to get our fair share of the market. And we are not probably there yet but we’re happy with the gains that we’ve gotten over the course of the time so far. As far as competitors go, this is a product that it was a grandfathered product for a long time, yet there is really only two competitors in it for a very long period of time so. We’re not — we don’t know of any other competitors, and so I would — our best guess is that even though we have a six-month exclusivity that goes into the — well into the fourth quarter here, we’re not expecting any significant number of competitors in the near future. So, we think this is going to be — remain a strong product with relatively high margins. And we think that we will get our reasonable share in the not-too-distant future.

Dan DischnerVice President of Corporate Communications

And that’s on our multi-dose vials. I think the other question or second part of your question was about the intranasal epinephrine? Is that correct?

Serge BelangerNeedham & Company, LLC — Analyst

Yeah, that’s correct.

Dan DischnerVice President of Corporate Communications

Okay. And how — now, can you revisit that question, because I think it kind of got mix in there was the first part?

Serge BelangerNeedham & Company, LLC — Analyst

Just your overall thoughts on what kind of opportunity you see with the intranasal products competing against these various injectables?

Dan DischnerVice President of Corporate Communications

Well, I think, as we said, we do believe that it presents a new way of — and a safer way maybe of having epinephrine. And we’re excited by it because the technology that’s behind it is — what we’ve seen has been very, very, very positive. The market opportunity, I think we said was — I think the IQVIA data for 2020 for the auto-injector epinephrine market is $4 billion. So, that’s the addressable market that we’re targeting. Does that help?

Serge BelangerNeedham & Company, LLC — Analyst

Yeah. Absolutely. And then, can we revisit the IMS UK products? I think these were acquired quite a while back. Can we just get an idea of how many products and the opportunity they represent?

Bill PetersChief Financial Officer, Treasurer, and Senior Vice President of Finance

Yeah, it was about eight products. And I think we’ve said, this is an annualized mid to high single-digit million-dollar opportunity for us. We waited until we had the new capacity online earlier this year to really focus on those because we really didn’t have enough capacity to satisfy the domestic market. But now that we have that — we had hoped to have that online earlier, but now that we have that capacity, we have turned our focus back to the UK market. And Tony can give you a little bit of an update on where we are with some of that and getting those products relaunched.

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Yeah. We have a number of products on file with the MHRA. They’re going through a little bit of a shuffle between Brexit as well as COVID. They’re essentially on locked down and most of the MHRA are working remotely. But nonetheless, we’re working with them on that. We are addressing any issues that come out, but the applications are on file with them, and we just continue to work through questions that they may have on that.

Serge BelangerNeedham & Company, LLC — Analyst

All right. Thank you.

Dan DischnerVice President of Corporate Communications

Thank you.

Operator

Our next question comes from David Steinberg of Jefferies. Your line is open.

Ed ChungJefferies — Analyst

Hi guys, it’s actually Ed Chung on for Dave. Couple of questions. You haven’t talked about your — I think you had talked about your first respiratory inhalation ANDA filing. Is there an update on that? And then, also just a quick question on your SG&A spend. Sequentially, what we should expect going into the fourth quarter and then in ’21, the investments that you’re looking to add on to this year?

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Yeah, hi, this is Tony. I can address the inhalation filing. The trials are wrapped up. All of the trials that we needed to do for that product, they are completed. And we’re just compiling information as we prepare for the filing that we anticipate to do later this quarter.

Bill PetersChief Financial Officer, Treasurer, and Senior Vice President of Finance

And as far as the SG&A spend, a lot of that in the quarter is related to legal expenses. Specifically, we were getting closer — we had a lot of expenses for the vasopressin case and also [Indecipherable] case. So now that the vasopressin case is settled, those go away. So that should flatten out somewhat, but in the selling expense line, we are targeting an increase in spending in the fourth quarter for advertising on Primatene MIST, and we’re also looking to increase that spending next year as well. But in both of those cases, our belief is that sales is going to sales are going to increase faster than our spend. So that will have increasing operating margins from that product.

Ed ChungJefferies — Analyst

Great. Thank you so much.

Bill PetersChief Financial Officer, Treasurer, and Senior Vice President of Finance

No problem.

Dan DischnerVice President of Corporate Communications

Operator, if that’s it?

Operator

At this time, I would like to turn it back to the speakers for any further comments.

Dan DischnerVice President of Corporate Communications

Great. I want to thank everybody for joining us today to share in our exciting news on our pipeline, specifically with our intranasal epinephrine product. We look forward to continuing to update you as these programs progress. And we look forward to a good net [Phonetic] in Q4, and meeting with everybody then.

Everybody please stay safe and have a good weekend.

Operator

[Operator Closing Remarks]

Duration: 46 minutes

Call participants:

Dan DischnerVice President of Corporate Communications

Bill PetersChief Financial Officer, Treasurer, and Senior Vice President of Finance

Tony MarrsSenior Vice President of Regulatory Affairs and Clinical Operations

Jacob HughesWells Fargo Securities — Analyst

Rafay SardarBMO Capital Markets — Analyst

Tim ChiangNorthland Capital — Analyst

David AmsellemPiper Sandler — Analyst

Elliot WilburRaymond James — Analyst

Serge BelangerNeedham & Company, LLC — Analyst

Ed ChungJefferies — Analyst

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