アンファスター・ファーマシューティカルズ（AMPH）2026年第3四半期決算説明会：過去最高の売上高、IMSコスト

アンファスター・ファーマシューティカルズの2026年第3四半期決算説明会では、過去最高の四半期売上高、BAQSIMIおよびPrimatene MISTの好調な売上、ならびにIMSの是正措置費用と製品価格下落による継続的な下押し圧力が強調された。

主要なポイント

• 売上高は前年同期比8%増、前四半期比13%増の2億760万ドルに達し、過去最高を記録した。
• BAQSIMIの純売上高は10%増の5,880万ドルと過去最高を記録した。販売数量の増加が740万ドルの押し上げ要因となった一方、220万ドルの価格低下要因により一部相殺された。
• Primatene MISTの純売上高は、第2四半期の値上げと販売数量の増加に支えられ、9%増の3,150万ドルと過去最高を記録した。
• 売上総利益率は、主に一部製品の価格低下とIMS是正措置に伴う製造コストの増加により、前年同期の51%から48%に低下した。
• 調整後純利益は、前年同期の4,470万ドル（希薄化後1株当たり0.93ドル）から4,930万ドル（同1.14ドル）に増加した。
• 経営陣は、是正措置の継続に伴うIMS製品売上の緩やかな減速を織り込みつつ、第4四半期の売上高が前年同期比で1桁台後半の増収になると予想している。

主要財務データ

取締役会はまた、アンファスターの自社株買いプログラムに対して5,000万ドルの追加枠を承認した。

事業および営業実績

BAQSIMIは引き続き開示対象製品の中で最大の売上規模を維持し、5,880万ドルの純売上高を計上した。アンファスターは、処方数の伸びについて、マーケティングおよび商業化の取り組みが反映されたものとしている。340Bプログラムにおける重複割引の可能性に対処する措置により、過去2四半期と比較して影響は軽減されたものの、経営陣は約80%の解決目標にはまだ達していないと述べている。

Primatene MISTの売上高は3,150万ドルとなり、店頭での販売数量は前年同期比で約2.5%増加した。経営陣は、価格設定と販売数量増の双方が成長に寄与したとしている。

最近投入された製品もポートフォリオの成長に寄与した。2026年4月に発売された臭化イプラトロピウムは660万ドル、テリパラチドは640万ドルの売上をもたらした。経営陣は、イプラトロピウムが市場シェアを拡大し続けており、決算説明会の時点では当該市場において唯一のジェネリック医薬品にとどまっていると述べた。

リドカインの売上高は、他社サプライヤーの供給不足に伴う需要増により29%増の1,660万ドルとなった。エピネフリンの売上高は、IMSの是正対応により出荷が減少したため19%減の1,530万ドルとなった。グルカゴンの売上高は、競争激化を背景に37%減の860万ドルに減少した。

その他の医薬品売上高は、テリパラチドおよびアンファスター子会社ANPによる620万ドルの原薬（API）売上に支えられ、9%増の7,020万ドルとなった。ただし、IMSの一部製品の出荷減により、これらの増収分は一部相殺された。

アンファスターは、FDA（米食品医薬品局）の承認を前提として2027年の発売を見込むインスリン・アスパルトの相互交換可能なバイオシミラーの開発作業を継続した。また、同社はAMP-101、AMP-109、AMP-110、AMP-107の各プログラムを前進させたが、これら独自の開発プログラムは依然として初期の開発段階にあることを強調した。

経営陣のガイダンス

経営陣は、2026年第4四半期の売上高が2025年第4四半期比で1桁台後半の増収になると予想している。この見通しには、同社が是正措置を優先する中でIMS製品の売上が緩やかに減速することが織り込まれている。

IMSの是正措置について、アンファスターは第3四半期に200万〜300万ドルの追加費用が発生したと見積もっている。経営陣は、今後2〜3四半期の各期において、この費用がやや高水準になると見込んでいる。

同社は2027年の正式なガイダンスを提示しなかった。それでも経営陣は、BAQSIMI、Primatene MIST、および通年換算したイプラトロピウムの売上が潜在的な成長要因になると指摘した。また、承認を条件として2027年にインスリン・アスパルトを発売できる可能性があるとの予想を維持したものの、確定した発売日はないと述べた。

リスクと主要課題

• BAQSIMI、グルカゴンなどの製品における平均販売価格の低下が売上総利益率を圧迫した。経営陣は、340B重複割引への対応が進展しているものの、BAQSIMIの価格設定が以前の水準に戻ることは想定していない。
• FDAの警告書を受けたIMSの是正対応は、生産スケジュール、製品の出荷、および製造費用に影響を及ぼした。経営陣は、これまでの影響は需要面ではなく主に業務運営面によるものであると説明した。
• IMSの製造施設では1,250万ドルの受注残を抱えており、リドカインなど各製品間で製造リソースの競合が生じている。
• 経営陣によると、インスリン・アスパルトが参入する市場には、すでに3〜4つの競合ジェネリック製品が存在しているという。
• 原薬（API）の出荷時期は、製造ロットの計上時期が決算の締め日の前後にずれる可能性があるため、四半期業績の変動要因となり得る。

アナリスト質疑応答の要点

経営陣は、アンファスターが340B重複割引の対策において約80%の目標に近づいているものの、まだ達成していないと述べた。同様のリソースを活用している他社の実績を踏まえると、その水準を超えた追加の進展は限定的になると見込んでいる。

IMSについて、同社はFDAへ定期的な進捗報告を行っており、外部パートナーとともに、より包括的な是正計画を実施していると述べた。新たな管理体制を支援し、生産能力を改善するために、品質管理リソースの追加投入が進められている。

経営陣は、具体的な売上目標の再確認は行わなかったものの、処方シェアの拡大に伴いイプラトロピウムの売上が増加すると予想している。インスリン・アスパルトについては、新たな参入者を受け入れるのに十分な市場規模があると評した一方、既存の競合の存在や確定した発売時期がないことを認めた。

アンファスターはまた、地球温暖化係数を低減した次世代型Primatene MIST製剤であるAMP-104についても言及した。同社は2028年末までの申請を目指しており、特許1件が承認済みで、もう1件が出願中であると述べた。

決算説明会 文字起こし全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Greetings, and welcome to the Amphastar Pharmaceuticals Inc. Third Quarter Earnings Call.

[Operator Instructions]

Please note that certain statements made during this call regarding matters that are not historical facts, including, but not limited to, management's outlook or predictions for future periods are forward-looking statements. These statements are based solely on information that is now available to us. We encourage you to review the section entitled Forward-Looking Statements in the press release issued today and the presentation on the company's website. Also, please refer to our SEC filings, which can be found on our website and the SEC's website for a discussion of numerous factors that may impact our future performance.

We will also discuss certain non-GAAP measures. Important information on our use of these measures and reconciliations to U.S. GAAP may be found in our earnings release. Please note, this conference is being recorded. Our speakers today are Mr. Bill Peters, CFO; Mr. Dan Dischner, Senior Vice President of Corporate Communications; and Mr. Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations. I will now turn the conference over to your host, Mr. Dan Dischner, Senior Vice President of Corporate Communications. Dan, you may begin.

Dan Dischner

Thank you, Paul. Good afternoon, everyone, and thank you for joining Amphastar's third quarter 2026 earnings call. Earlier today, we reported our financial results for the third quarter ended September 30, 2026, which are available on the Investors page of our website. The third quarter was marked by record commercial performance, continued progress on our IMS remediation efforts and earlier advancement of our development pipeline. We achieved quarterly revenue of $207.6 million, up approximately 8% year-over-year and 13% sequentially.

Growth was driven primarily by strong performance from BAQSIMI and Primatene MIST supplemented by contributions from recently launched products. Gross margin decreased during the quarter, primarily driven by the impact of lower net pricing on certain products and higher manufacturing expenses, including costs associated with the remediation efforts at our IMS manufacturing facility. Bill will provide additional detail on these factors as well as the year-over-year earnings comparison in the financial review.

Our strategy remains focused on 3 complementary growth priorities: First, maximizing the growth of BAQSIMI and Primatene MIST while expanding our differentiated commercial portfolio; second, advancing our pipeline of complex generics and biosimilars; and third, progressing our proprietary development program. Our scientific manufacturing and commercial capabilities support each of these initiatives.

I would like to provide an update on each, beginning with our commercial portfolio. BAQSIMI delivered record quarterly net sales of $58.8 million, representing growth of approximately 10% compared to the prior year's period. The increase was driven by higher unit volumes, partially offset by lower net pricing associated with commercial discounts and customer mix. During the quarter, the measures we implemented to address duplicate 340B discounts continue to produce results, further reducing their impact relative to the second quarter. We remain focused on driving prescription growth, expanding patient access and executing our commercial strategy to maximize the long-term value of the franchise.

Primatene MIST delivered record quarterly net sales of $31.5 million, an increase of approximately 9% compared to the prior year's period. Growth was driven by both the price increase implemented in the second quarter and higher unit volume, with in-store unit sales increasing approximately 2.5% year-over-year. These results highlighted the strength of our commercial operation and our ability to successfully manage differentiated pharmaceutical products across multiple markets and distribution channels.

More recent product launches also contribute meaningfully during the quarter. Specifically, ipratropium bromide, which launched in April, generated $6.6 million of sales, while teriparatide contributed $6.4 million. These launches supported overall portfolio growth and partially offset headwinds affecting certain established products, including Glucagon injections. Our commercial portfolio continues to provide the cash flow and operational foundation needed to invest in the development, manufacturing and commercial capabilities that support our pipeline of complex generics, biosimilars and proprietary medicines. During the quarter, we continued to invest in manufacturing initiatives that support both our existing portfolio and future growth opportunities and activities related to our insulin and proprietary development program.

Our U.S.-based manufacturing footprint and vertically integrated operating model remain important competitive advantages as we prepare for future product launches. We also remain focused on addressing matters related to our IMS facility. Following the FDA's warning letter received earlier this year, we continue to implement corrective actions and advance our remediation efforts. These activities affected production schedules and the timing of certain product releases during the quarter, resulting in lower sales of certain IMS manufacturing products and higher manufacturing expenses. It is important to note, the impact to date has been primarily operational in nature rather than demand related. We continue to work closely with the FDA while maintaining the supply of essential medicines, including products that help address ongoing drug shortages.

At the same time, we remain committed to fully addressing the agency's observations, maintaining the supply of important medicines and achieving sustainable improvements in our quality and manufacturing system. Bill will provide additional detail on the financial impact of these activities, our current expectations for remediation related spending and our broader business outlook.

Turning to the second and third pillars of our growth strategy. We continue to make progress across our development pipeline during the quarter. For our Insulin Aspart biosimilar interchangeable program, we remain on track to support a potential commercial launch in 2027, subject to FDA approval. During the quarter, we advanced the clinical and manufacturing activities needed to support the program and continue preparing for commercialization. Development activities also remain ongoing across our broader biosimilar portfolio as well as additional complex inhalation and injectable product candidates.

Our proprietary pipeline also remains an important part of our long-term growth strategy. For AMP-101, our intranasal epinephrine program, we continued clinical development activities following the initiation of our Phase I program in the second quarter. In the third quarter, we refined the study design and formulation based on regulatory feedback as we continue to advance the clinical development program.

We believe AMP-101 has the potential to provide patients with an additional non-injectable treatment option specific to -- for severe allergic reactions, including anaphylaxis. For AMP-109, our peptide-coupled docetaxel oncology program, we continued nonclinical studies and manufacturing preparations during the quarter, building on the constructive FDA feedback received earlier this year regarding our proposed development approach.

We also continued development of AMP-110, our synthetic human corticotropin program, including the evaluation of potential therapeutic indications and additional nonclinical studies to support a clinical development program.

Development activities also continue for AMP-107, our proprietary ophthalmic program targeting wet-age-related macular degeneration and diabetic macular edema. Our goal is to develop a differentiated eye-drop treatment alternative for conditions currently treated primarily through intraocular injection, which we believe significant unmet needs remain.

While these programs remain in early stages of development, we believe they represent meaningful long-term opportunities, and we are focused on disciplined investment as we advance them towards key development milestones. I will now turn the call over to Bill Peters, our CFO and Executive Vice President of Finance, for a more detailed third quarter financial review. Bill?

William Peters

Thank you, Dan, and good afternoon, everyone. In my comments today, I will discuss the third quarter results and then update some of our assumptions for 2026. Revenues for the third quarter increased 8% to $207.6 million, which is the highest amount we have ever recorded in one quarter. This compares to $191.8 million of revenue in the previous year's period. Ipratropium bromide inhalation, which we launched in April, led the growth with strong sales of $6.6 million. BAQSIMI revenues increased 10% to $58.8 million compared to $53.6 million in the prior year period, primarily due to an increase in units sold, contributing $7.4 million of sales, driven by our continued marketing efforts. This increase was partially offset by lower average selling prices, which negatively impacted sales by approximately $2.2 million, primarily as a result of higher rebates and higher 340B pharmacy discounts, some of which may have been duplicated.

Although rebates and 340B discounts remain a year-over-year pricing headwind, the impact was significantly smaller than in the previous 2 quarters, reflecting the positive impact of the measures we implemented to identify and resolve potential duplicate 340B discounts.

Primatene MIST sales rose 9% to $31.5 million in the third quarter, up from $28.8 million in the third quarter of last year due to both a recent price increase and an increase in unit volumes as we continue to see strong in-store demand. Sales of lidocaine increased 29% to $16.6 million from $12.9 million in the prior year period, driven by higher demand due to a shortage from another supplier. Epinephrine sales decreased 19% to $15.3 million from $18.8 million in the prior year period, primarily due to lower product releases at our IMS facility as a result of the remediation efforts related to the FDA warning letter.

Glucagon sales declined 37% to $8.6 million from $13.6 million due to increased competition. Other pharmaceutical product sales increased 9% to $70.2 million from $64.1 million, primarily due to sales of teriparatide contributing $6.4 million, which we launched in December 2025. API sales of $6.2 million from our ANP subsidiary also had a positive impact on sales. These increases were partially offset by a decrease in sales for several IMS products as a result of the remediation efforts at that facility.

Cost of revenues increased 16% to $108 million from $93.2 million and gross margin decreased to 48% of revenue in the third quarter of 2026 compared to 51% from the previous year's period. The primary drivers of the change were lower average selling prices for BAQSIMI, glucagon and epinephrine multi-dose vial product. Additionally, we had increased manufacturing costs at our IMS facility related to the remediation efforts. These factors were partially offset by sales of recently launched products to higher margins such as Ipratropium bromide and teriparatide.

Selling, distribution and marketing expenses increased 4% to $11.9 million from $11.5 million, primarily due to higher freight expense. General and administrative spending decreased 57% to $16.8 million from $39.5 million, primarily because the prior year period included a legal settlement. Research and development expenditures decreased 10% to $20.1 million from $22.3 million as the previous year period included a onetime payment for our licensing agreement. This decrease was partially offset by higher expenses for our insulin and proprietary product pipeline.

Our nonoperating expenses of $1.7 million during the period compared to nonoperating expense of $3.8 million in the prior year period, primarily due to foreign currency fluctuations as well as mark-to-market adjustments related to our interest rate swap. Net income in the third quarter increased to $37.8 million, an increase on a per share basis to $0.87 from $17.4 million or $0.37 per share in the third quarter of 2025. Adjusted net income rose to $49.3 million or $1.14 per share in the third quarter compared to an adjusted net income of $44.7 million or $0.93 per share in the third quarter of last year.

Adjusted earnings exclude amortization, equity compensation, impairment of long-lived assets and onetime events. In the third quarter, we had cash flow from operations of approximately $43.3 million. Separately, our Board of Directors authorized an additional $50 million for our share buyback program.

Looking ahead to the fourth quarter, we expect sales to increase in the high single-digit range compared to the fourth quarter of last year. This guidance incorporates a modest slowdown in IMS sales as we prioritize corrective actions to strengthen our quality and manufacturing systems. I'll now turn the call back over to Dan.

Dan Dischner

Thank you, Bill. The third quarter reflects continued execution across our business, led by record sales of BAQSIMI and Primatene MIST, along with contributions from recently launched products. These results reinforce the value of our commercial platform we have built to provide an important foundation for our long-term strategy. We also continued to make progress on several important operational and strategic initiatives during the quarter.

At IMS, we advanced our remediation efforts and continue working closely with the FDA while maintaining supply of essential medicines. Across our development portfolio, we continue to advance our complex generics, biosimilars and proprietary programs while maintaining a disciplined approach to capital allocation and investment. We believe Amphastar is well positioned as a diversified pharmaceutical company with established commercial products, a U.S.-based manufacturing footprint, vertically integrated capabilities and a growing pipeline of differentiated opportunities.

Our priorities remain clear: sustaining commercial performance, strengthening our operations, advancing our pipeline and creating long-term value for our shareholders. With that, we will take your questions. Paul?

Operator

[Operator Instructions]

Our first question is from Ekaterina Knyazkova with JPMorgan.

質疑応答

Ekaterina Knyazkova

So firstly, just on BAQSIMI, and I think you've mentioned this, but just in terms of the double dipping, how much of it has been addressed at this point? I remember you were targeting 80%. Just how close are we to that 80%? And is that still the target? Or do you think you can kind of even go beyond that?

And then second question is just -- I know it's early, but just as you kind of start thinking about 2027, just any early thoughts on your pushes and pulls, both on the revenue side and EPS side as we think about next year?

William Peters

Sure. On the first question, we're not at that 80% yet, but we're getting closer. We don't think we'll get past that because that's where the other companies that are using the same resources have gotten to. So we think there's a little bit more room to go, but not a lot. As I mentioned, we still had a $2.2 million headwind this quarter from pricing. That was primarily, I think, these duplicate discounts. But as you can see from the numbers, it was a lot better than it has been for the last 2 quarters. So we're really happy with the progress we've made there.

Looking forward to 2027, we're not prepared to give guidance at this point. But I will say that we are still expecting strong growth from BAQSIMI, growth from Primatene MIST, annualized sales of Ipratropium bromide. So we have a lot of positive things for next year.

Ekaterina Knyazkova

And then if I can squeeze in one more. Just on the IMS facility and the remediation. Can you just quantify the impact in Q3 a bit more? Is it $5 million, $10 million? And just how should we think about impact in the fourth quarter? And any impact that we should potentially think in 2027?

William Peters

Sure. So it's probably between $2 million and $3 million of the extra expense in this quarter, and it will probably be a little bit higher than that in each of the next 2 or 3 quarters.

Operator

Our next question is from David Amsellem with Piper Sandler.

Naoki Martin

This is Naoki on for David. The first one on BAQSIMI. As you work through the duplicate discounting issue, is it reasonable to expect some net pricing recovery towards historical levels in 2027, so that's number one. And next also on BAQSIMI. Scripts have continued to look strong here. So can you give us some color on what's driving the growth? Are these new patients in the category switches? Any color would be helpful here.

William Peters

Sure. So we don't think we'll get back to pricing that we had previously because of this double dipping. And even the 3% price increase that we took this year doesn't fully offset that. So we still have that pricing headwind going into next year. But remember, we had a bigger pricing problem in the first quarter of last year because that's when the peak double discounting. So we'll have some easier comps as we run into the year. And then...

Dan Dischner

What's driving the growth?

William Peters

Oh yes. Primarily, it is our marketing and commercialization efforts. And it's sort of how we've expected since we acquired the product to be at around these levels, maybe it's a little higher than we expected, but it's right around where we expected. It's bringing awareness to BAQSIMI and our team has been working on those efforts throughout. So I think that's really what's driving the growth.

Operator

Our next question is from Dennis Ding with Jefferies.

Yuchen Ding

I have two. So in regards to the IMS facility, it sounds like it'll be mid-2027 before it gets back to full capacity. How involved is the FDA in doing some of these quality control checks or how involved are they in the process? And is there a risk of them having to shut down that specific prefilled syringe line? And then question #2, on Ipratropium. It's annualizing at around $25 million. So I believe historically, you'd characterize this as a $50 million opportunity. Given that we haven't seen a major yet, do you expect this to keep growing and we eventually get to $50 million? Or what's gating that from happening?

William Peters

Yes, Dennis, for your first question about the IMS facility, we send routine updates to the agency. We gave them an overall plan. And this is in conjunction with working with our third party partner. And essentially, we just provide routine updates to them on the progress of each of the different work streams that we're working through. So the progress of that is going very well. We're progressing through it. I mean we'll continue those updates into the year.

Dan Dischner

And also to add on that, the FDA was looking for several things, specifically, and what we've done is a more comprehensive plan, but we're working on things that weren't even asked for by them as well. So multiple things that we're working on at once. We will continue to work on that. And as far as getting back to capacity, I think we're pretty close to actually being there because part of what we had to do was add some additional resources to the quality group to help because we've added some controls there. And because we've added these controls, we needed some more resources. Now we're adding those resources. And we think that the -- we should be able to pick up relatively soon back to where we were before.

And as far as ipratropium goes, yes, we think that sales should continue to increase from where we were this quarter because what we've seen is that we had a little bit of loading in the second quarter. So that was partially why the third quarter was a little lower than the second quarter. But what we're seeing is continued share growth for our market share.

So as those prescriptions continue to grow, we expect that our sales will continue to grow. And we don't know when there will be another generic, but as of right now, we are the only generic in that market.

Operator

Our next question is from Serge Belanger with Needham & Company.

Serge Belanger

First one regarding lidocaine, it looks like you benefited from some supplier shortages. Do you expect these shortages will continue being a benefit into 2027? And then secondly, as we approach 2027 and look at the potential new launches, I think you've talked about the GLP-1 generic, which is expected to be competitive as well as the insulin biosimilar. Just curious if you could frame the opportunity of the insulin biosimilar? Could it be another opportunity similar to the Ipratropium launch? Or will it be drastically different from that?

William Peters

Yes. As far as the lidocaine goes, we do expect the demand for that product to continue into next year, but it does become a matter of overall resources on what we were able to deliver from that facility because of the tightness that we've had and the things. So if you take a look at our 10-Q, which we put out today, one of the things is that we have a larger back order from that facility than we've had in the past. It's up to $12.5 million now. So we have competing demands on our resources there. So we were able to ship Lidocaine this quarter. We plan and intend to try to get out as much as we can next quarter. But as of right now, we do see the demand for that product continuing to hold up as well as demand for other products that we weren't able to execute on yet.

Dan Dischner

[indiscernible] new launches. As we've pointed out before, on AMP-018, we do expect that to be a limited opportunity for us due to the competitive nature of that environment. However, we do remain on track for the 2027 commercialization. And then the insulin biosimilar, our insulin Aspart product. Yes, we also know that there's 3 or 4 competitive generics already in the market. So we've said all along, it's a large market. So we feel like there is still room for us to fit into that.

Operator

Our next question is from Jason Gerberry with Bank of America.

Jason Gerberry

Just wanted to tease out a little bit, if you can, to sort of the drag on gross margins this quarter. Was that mainly IMS? Was it more of the BAQSIMI price called out? And when would you kind of expect GMs to kind of bounce back to kind of more normalized levels?

William Peters

Sure. So a pricing issue more than anything else and that pricing reduction comes from BAQSIMI and from glucagon and from the antivirals. So we had 3 products that were high-margin products that had some margin pressures on them. Additionally, we did have that increased $2 million to $3 million of expense at IMS plus some additional expense at the Amphastar facility as we're building out some, as we've taken on some new capacity here. So I think in order to get the gross margins back to where they were, I think we need to get our volume levels up a little higher with some things.

And I think one of the things that can do that is the Insulin Aspart because that will be taking advantage of both underutilized capacity at our ANP facility for the API and also our unused finished product capacity here at Amphastar.

Operator

Our next question is from Glen Santangelo with Barclays.

Glen Santangelo

Two quick ones for me. Bill, I want to talk to you about, sort of, the other category. I mean you put a pretty decent growth there, and you called out specifically teriparatide and the API sales. And we're obviously, I think, going to launch the -- or get to the anniversary of the launch of teriparatide. And so I'm just trying to think about the durability of that growth as we head into 2027. Any sort of commentary you can give us around that, I think, would be helpful.

And then secondly, as you look to '27, I also wanted to follow up on the insulin biosimilar. I mean it feels like the company's sort of biggest incremental opportunity in '27. I was wondering if you could maybe just give us a little bit more detail about sort of probability of that launch, the timing of that launch, the margin profile of that product? Anything you can sort of give us to help us think about that opportunity would be helpful.

William Peters

Sure. As far as the other income goes, you're right, teriparatide does annualize into the fourth quarter this year, but the sales of that are holding up strong. So maybe we don't get growth out of that, but I think we still will have strong sales. Additionally, with the API sales out of the ANP facility that we've had 2 quarters of about the same level of sales, and we expect sales to continue around that level. However, those are a little bit lumpy because they're shipping out batches of API one at a time and sometimes the timing of those things can be a little off from our quarterly cut-offs.

The other thing is I'll just go back to what I was saying on the last question, which is we have a growing backlog because of some of the increased controls that we added at the IMS facility. So we have an opportunity there as well to reduce that backlog. And so there were several products in that other category, where we had -- were unable to ship because of some of the things we were doing there. So our goal for this quarter would be reduce that backlog and get those sales out.

And then as far as the insulin biosimilar, we've said next year launch. I think it was, I'll say, imminent, that we probably talk about a first quarter launch in thought. So it's not something that we can really -- we don't have a firm date on that launch at this point.

Operator

Our next question is from Ben Burnett with Wells Fargo.

Unknown Analyst

This is [indiscernible] on for Ben. There seems to have been a small delay in the AMP-005 and 017 filings from the first half of '27 to the second half, can you help us understand what drove that? Would the delay be related to data, FDA feedback? Or is it more of a capacity issue?

William Peters

I wouldn't categorize it as any of those. I think it's just a normal development process delays, nothing in particular as far as an interaction with the FDA or anything like that. I think it's just a normal part of the development process.

Unknown Analyst

And if I may just quickly on AMP-104. We noticed that's a next-generation Primatene program in your pipeline. Can you help us understand what drove the new program and what the development path looks like there? And secondly, would you expect it to extend Primatene's IP protection?

William Peters

Yes. So this is the new Primatene MIST formulation that we've been talking about for a little while now. It has a lower global warming potential. We're just including that on the proprietary side. We haven't included in the past, but we wanted to add it there just to give some people an idea of the timeline for that. So -- and yes, we've already filed and have one patent approved, and we filed another one. So we're hoping to have significant patent protection on that product as well. And we just thought we'd add it to the deck so you'd understand, our goal is to file that by the end of 2028. So we think it's an important [indiscernible] to protect the long-term Primatene MIST brand.

And I'll add a little bit of context to that is the EPA has drawn back some of the -- is on a drawdown for HFA. And so this is something the FDA has taken to eventually get rid of that as a propellant. And so this is just our development program to maintain and be compliant with those regulations.

Operator

Thank you. There are no further questions at this time. I'd like to hand the floor back over to management for any closing remarks.

Dan Dischner

Thank you, Paul, and thank you all for your questions today. We appreciate your continued interest in Amphastar and look forward to updating you on our progress next quarter. Have a great day.

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you again for your participation.