Amphastar Pharmaceuticals (NASDAQ:AMPH) Q3 2020 Earnings Call

0:00 Good morning, ladies and gentlemen, and welcome to the Amphastar third quarter earnings call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touch-tone telephone. As a reminder, this conference call may be recorded. All statements in this press release and in the conference call reference 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 DMS of ANP, the timing of the 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 the business operations and results

1:35 of operations. These statements are not historical facts but rather are based on Ma'am Phastar 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 may contain these words.

2:26 You should not place any reliance on forward-looking statements because they involve unknown 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 AFASTAR'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.

3:13 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 the 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 of the dates of release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call reference above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar's expectation to change.

4:32 I would now like to turn the conference over to your host, Mr. Dan Dischner, Vice President of Corporate Communications. Please go ahead, sir.

4:44 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 primatine 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 internasal epinephrine, an NDA that will target the epinephrine auto-injector market. Thus far, our internasal epinephrine product has completed its Phase I clinical trial, and we plan to begin Phase II clinical trials in the first quarter of 2021.

5:34 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 an 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 an autoinjector. 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 autoinjectors, the 2020 Equivia data annualized sales has an addressable market of over $4 billion.

6:25 Moving on to business, our third quarter saw sales growth of 4% compared to the same period in 2019. Thank you for joining us. We will soon publish an updated presentation on our website where you can observe that Primatine 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 Primatine. Therefore, our ad spend for Primatine will increase by 20%, or to put it in dollar terms, in the range of an additional $1 to $2 million on an annualized basis. Thank you for joining us.

8:00 Thank you for joining us. Thank you for joining us. or the fourth quarter if another pre-approval inspection was needed.

8:56 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 AMP001 is still in the same review cycle, we continue to maintain a positive dialogue with the agency and are still excited about AMP001 as it is still on track to become the first generic to hit the market. Regarding AMP002's projections, We remain confident that the agency will find it to be therapeutically equivalent and continue to anticipate a fourth quarter GDUFA target action date. Although news about AMP001 may temper AMP002 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 towards 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 towards completion, we'll provide one as we approach closer to the date in the future.

10:08 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 Inoxaparin briefly. Although there have been exits and a new entrant into the Inoxaparin 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 longstanding experience in this area since we are the only company that manufactures both the Noxaparin's API and finished product in the United States.

11:26 Finally, we continue to see success in our pipeline development as demonstrated by our intranasal epinephrine products progress. We remain committed to the prospects of AMP001 and 002 while we anticipate primatine sales to trend upward as we approach allergy season. Although factors outside of Amphistars 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.

12:17 Thank you, Dan. Sales for the third quarter increased 4% to $83.4 million from $80.1 million in the previous year's period. Primatine 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 primatine myths in Kroger, which is one of the largest grocery chains in the country. Anoxaparin sales increased 22% to $11.6 million from $9.6 million as Teva left the anoxaparin market. Epinephrine multi-dose vials had sales of $2.8 million in the second quarter back on the market.

13:03 Other finished pharmaceutical products sales declined 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 $4.4 million last year, as last year's sales numbers included a $1.5 million amendment fee from Mankind. Cost of revenues increased to $46.9 million from $44.9 million. Gross margins were relatively unchanged at 44% of revenues, We had increased gross margins related to newer, higher margin products such as primatine mist and epinephrine multi-dose vials, which were offset by lower sales of naloxone and other finished pharmaceutical products.

13:52 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 primatine 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.

14:39 The company reported net income attributable to Amphistar shareholders of $3.9 million or $0.08 per share in the second 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 10 cents 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.

15:26 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.

15:36 Yes, operator, we're ready for the Q&A. Ladies and gentlemen, if you have a question at this time, please press the star and then the number one key on your touchstone telephone. If your question has been answered, or you wish to remove yourself from the queue, please press the pound key. Our first question comes from Jacob Hughes of Wells Fargo Securities. Your line is open.

16:14 Hey, thanks for taking the question. I wonder if you could just comment on the trends for Primati. In the quarter, it looked like the growth slowed a bit sequentially, and we had the leveling off and the pantry low 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's any other retailers you could launch in, and how you're thinking about the upside to the $65 million annual sales target.

16:45 Sure, great. Yeah, we still, private team still, the trajectory is still good. You know, there might have been some, you know, slow because, you know, the pantry loading as we've talked about in the past, but we still feel like, you know, the trajectory has kind of returned to what we expected it to be. You know, Kroger, introducing it to 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, 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.

17:32 We hope that will also help with the growth of the sales. As we've 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. We believe that those peak sales of $65 million that we had previously, we believe we can get back to there really easy.

17:56 Yeah, and just a couple more points. One is that we're updating the slide 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, I said Kroger earlier in the quarter. It actually wasn't earlier in the quarter. It was 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. Thank you.

18:26 Got it. That's helpful. And then just on 001, is there anything you could comment around, you know, what's causing the delay at the FDA? Thanks.

18:36 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're 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.

19:14 Thanks a lot, guys. Good morning Gary, are you there? Can you hear me? Ah, there you are.

19:57 Are you there?

20:03 Hello? Operator, we don't hear anything on our end. Yeah. One moment, sir.

20:36 Operator, can we just move to the next question? Thank you, Mr. Gary Nachman. Your line is still open.

20:46 Hi there. Can you hear me? Yes. There we go. 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 two trial and what additional studies would be required after that?

21:13 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 one. The results are very promising. The PK profile is very encouraging. And we're planning to go into the phase two 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.

22:11 Thanks. And then I was also hoping you could comment on gross margin heading into 2021. I know there was an incremental benefit in 2020 for Primatine that won't reoccur, so just any color there would be helpful. Thank you.

22:29 Yeah, so while we did have the issue with Primatine 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 amount of the cost of goods. However, the primatine mist is still going to be growing next year, and because of that, we'll 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.

23:15 So we think that those trends will help us increase our gross margins next year.

23:23 Thank you. Our next question comes from Tim Chang of Northland Capital. Your line is open.

23:36 Hi, thanks. You know, it looked 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. You know, obviously, you're still waiting for 001. What do you guys think the likelihood is that these product approvals really shift into 2021?

24:15 The first thing there, Tim, is that there's 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 competitor return to the market, so that was what was causing the sales decline there, and that should continue in the future. But things like Primatine are very strong, and we expect growth in that product definitely in the fourth quarter and well into next year. We still are talking about $65 million as our sales target for next year. And on AMPOO-102, 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. Okay.

25:07 And then can you talk a little bit about just the epinephrine multivial injection product? I mean, how is that doing in the hospital market? I know you were basically the first generic into that market. Were there other competitors that entered?

25:25 No, we're the only one still. We have a six-month exclusivity, so happy to be in that position. We are gaining market share, and the sales last quarter were primarily loaded into the wholesalers, and the sales this year, which were higher than last quarter, were restocking and indicate the actual sales levels that we have now. Our market share grew over the course of the quarter, so we think that the that product will also continue to grow sales as we look into the fourth quarter next year.

26:02 Okay. And then maybe just one last question on this intranasal epinephrine. You know, given the phase one data that you have, I mean, what's your plan in 2021? I mean, are you going to need to, I mean, what additional studies will you need to run I'm 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?

26:32 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, we'll 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 will 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 the comments that we've received from the agency on this have been very positive.

27:26 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. We think the agency is as well.

28:01 Okay, great. Thanks. Thank you. Our next question comes from David M. Solomon of Piper Cellular. Your line is open.

28:16 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 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.

29:10 Yeah, I can speak to the pre-approval inspections for these two products, MP001 and 002. We previously disclosed that we've had inspections for both of these products. MP002 in particular is the most recent set, and these were very rigorous inspections where 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.

30:00 And your second question related to the shortages, there were multiple shortages and many of our critical care products that are on the hospital crash carts includes products like Dextro, 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 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 do that, and we have the increased capacity that we put on earlier this year.

30:59 So we do have the capacity and the ability to meet demand should they have shorter-distance seizures. Great.

31:08 Great. Thanks, guys. Thanks. Our next question comes from Elliot Wilbur of Raymond James. Your line is open.

31:22 Thanks. Good morning. Just the first question I want to ask was around the intranasal epinephrine development program. I'm presuming the path to approval is via a BE study versus injectable epinephrine, but just wanted to ask you to confirm if that's the case.

31:44 While we're doing the route of approval is the NDA through the 505 route, so I wouldn't quite call it a BE, but 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 we'll be comparing it to.

32:14 Okay, so I guess, still trying to understand, is this, you know, a PK-based study, or is this, or they're going to actually, I mean, there's not endpoints in studies like this. That's impossible, but I'm just trying to get a little bit better sense of, you know, what has to happen given sort of the relatively short timeline that you have outlined in terms of potential filings.

32:45 I want to be careful about not disclosing too much. What I will say is there's a strong PK component to it. Maybe that will give you enough. Okay. And is this an internally developed program or is it partnered? 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.

33:47 And once you see what that is and how we're doing, I think it's going to be clear how advantageous this product will be.

33:58 Okay. Thanks for that. and I just want to ask you a question on Noxa Parent Trends in the quarter. You may have addressed this in your prepared commentary. I apologize. I got in 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. I'm just trying to get a sense of how – How sustainable this increase

34:35 is? It's not off-contract sales. Basically, when Teva left the market, we were able to gather a portion of what they had. Hopefully, our sales level can stay at this level. This market has seen a lot of twists and turns, but As Dan did say in his prepared remarks, 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 U.S., and we're very confident about our prospects for this product as a long-term generator of value for us.

35:14 Speaking along the lines of long-term value generation, with Teva leaving the market, any chance that this product starts behaving more like the biosimilar that it is rather than a commodity generic in terms of pricing?

35:28 That's our hope, but we haven't necessarily seen that yet.

35:34 Okay, fair enough. Just real quickly on Primatine, haven't seen the updated slide deck yet to get the latest data in terms of sort of the Any other metrics 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 is sort of how we look at that.

36:06 Thank you for joining us. 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 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 it's received in that group.

36:58 and just, you know, the chart that'll be on the investor slide does show continued upward growth in the weekly sales. So we'll say that.

37:11 Okay. And just a last question. You are a and a filer on vasopressin. Been 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 may, in fact, not have a blocking and exclusivity position and has also suggested it may be in 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.

37:49 Sure. So it'll 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's multiple filers. So that's all we can really say at this point.

38:12 Okay, good. Thank you. Have a good day. Our next question comes from Serge Belanger of Needham. Your line is open.

38:24 Hey, good afternoon. A couple questions on the epinephrine opportunity here. I guess the first one is once your 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, you know, as you think of your new epinephrine product and developments, what kind of role do you think it could play in this epinephrine market?

39:02 Yeah, okay. So the size of the market, I do know it's currently over $100 million in size. And so we expect to get a 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 of the time so far. As far as competitors go, this is a product that was a grandfathered product for a long time, yet there was really only two competitors in it for a very long period of time. We don't know of any other competitors. Our best guess is that even though we have a six-month exclusivity that goes 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 remain a strong product with relatively high margins. And we think that we will get our reasonable share in the not too distant future.

40:12 And that's on our multi-dose vial. Yes. I think the other question or second part of your question was about the intranasal epinephrine. Is that correct?

40:21 Yeah, that's correct.

40:23 OK. Now, can you revisit that question? Because I think it kind of got mixed in there with the first part.

40:35 Just your overall thoughts on what kind of opportunity you see with this intranasal product competing against these various injectables.

40:48 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, you know, we're excited by it because the technology that's behind it is, you know, what we've seen has been very, very, very positive. So, you know, the market opportunity, I think we said was like, I think the Equivia data for 2020 is, for the autoinjector epinephrine market is $4 billion. So that's the addressable market that we're targeting. Does that help?

41:26 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?

41:44 Yeah, there's about eight products, and I think we've said this is an annualized mid-to-high single-digit million-dollar opportunity for us. We've waited until we had the new capacity online earlier this year to really focus on those because we really didn't have enough Thank you very much.

42:22 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 lockdown and most of the MHRA are working remotely. But nonetheless, we're working with them on that. We are addressing any issues that come up, but the applications are on file with them and we just continue to work through questions that they may have on that.

42:54 All right, thank you.

42:56 Thank you. Our next question comes from David Steinberg of Jefferies. Your line is open.

43:07 Hi, guys. It's actually Ed Chung on for Dave. A couple questions. You haven't talked about your – I think you had talked about – Your first respiratory inhalation and the filing, is there an update on that? And then also just a quick question on your SG&A spend, you know, and kind of sequentially kind of what we should expect going into fourth quarter and then kind of in 2021. You know, the investments that you're looking to add on to this year.

43:52 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're completed, and we're just compiling information as we prepare for the filing that we anticipate to do later this quarter.

44:14 And as far as the SG&A spend, a lot of that in the quarter was related to legal expenses. Specifically, we were getting closer. We had a lot of expenses for the vasopressin case and also the Lexiscan 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 Primatine 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 are going to increase faster than our spend so that we'll have increasing operating margins from that product.

45:16 Thank you so much.

45:17 No problem. Operator, that's it? At this time, I would like to turn it back to the speakers for any further comments.

45:38 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 Q4 and meeting with everybody then. Everybody please stay safe and have a good weekend. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation and have a wonderful day. You may all disconnect. Thank you for watching.

46:54 Music Music Music Music Music and many more. and many more.

51:48 Thank you. and many more.

55:11 Transcription by CastingWords Transcription by CastingWords

1:02:43 and many more.

1:10:34 Net revenues in Q3 compared to the prior quarter saw a decrease of 3%. We are attributing this 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 primatine mist, Thank you very much. Thank you for joining us.

1:11:50 and on a final note on Primatine, 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 Primatine, 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 vials 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.

1:12:47 With our AMP001 product, we were given a GDUPA target action date for the third