Q2 2024 Amphastar Pharmaceuticals Inc Earnings Call

August 7, 2024

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Operator: Greetings and welcome to Amphastar Pharmaceuticals' second quarter earnings. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keyboard.

Operator: 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 at the SEC's, 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.

Operator: Greetings and welcome to the Amphastar Pharmaceuticals second quarter earnings At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keyboard.

Speaker Change: Greetings and welcome to the Amtrust start Pharmaceuticals second quarter earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.

Operator: 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 this section entitled "Forward-looking Statements" in the press release issued today in the presentation on the company's website. Also, please refer to our SEC violence, which can be found on our website and the SEC's website for a discussion of numerous factors that may impact our future performance.

Operator: 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 the public. 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.

Operator: 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 the public. 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.

Speaker Change: 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.

Speaker Change: Issued today and the presentation on the Companys website.

Speaker Change: 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.

Operator: We will also discuss certain non-gap measures. Important information on our use of these measures and recommendations to US GAAP may be found in our earnings release. Please note this conference is being recorded.

We'll 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.

Operator: 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'll now turn the call over to your host, Mr. Dan Dischner, Senior Vice President of Corporate Communications. Dan, you may begin.

Speaker Change: Please note. This conference is being recorded our speakers today are Mr. Bill Peters CFO, Mr. Dan Dishner Senior Vice President Corporate Communications, Mr. Tony <unk> Executive Vice President of regulatory Affairs, and clinical operations I will now turn the call over to your house, Mr. Gander here Senior Vice President of corporate Communications.

Operator: Our speakers today are Mr. Bill Peters, CFO; Mr. Dan Dishner, Senior Vice President of Corporate Communications; and Mr. Tony Mars, Executive Vice President of Regulatory Affairs and Clinical Operations.

Dan Dishner: I'll now turn the call over to your host, Mr. Dan Dishner, Senior Vice President of Corporate Communications. Dan, may be in.

Speaker Change: You may begin.

Dan Dischner: Thank you, Paul. Good afternoon, and thanks for joining us for our second quarter earnings call of 2024. Joining me today will be Bill Peters, CFO and Executive Vice President of Finance, and Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations. It has now been over a year since the successful acquisition of Baximi, underscoring Amphastar's strategic focus on expanding our portfolio with proprietary products, biosimilars, and complex products. This quarter, Vaksimi has emerged as a key driver, achieving impressive worldwide sales of $38.5 million for the quarter, representing a 10% increase compared to the same period last year, and highlighting this product growth. Overall, the quarter concluded with solid sales growth, driving total revenues to $182.4 million, representing an impressive 25% increase year-over-year.

Dan Dischner: Thank you, Paul. Good afternoon, and thanks for joining us for our second quarter earnings call of 2024. Joining me today will be Bill Peters, CFO and Executive Vice President of Finance, and Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations. It has now been over a year since the successful acquisition of Baximi, underscoring Amphastar's strategic focus on expanding our portfolio with proprietary products, biosimilars, and complex products. This quarter, Vaksimi emerged as a key driver, achieving impressive worldwide sales of $38.5 million for the quarter, representing a 10% increase compared to the same period last year and highlighting this product's potential. Overall, the quarter concluded with solid sales growth, driving total revenues to $182.4 million, representing an impressive 25% increase year over year.

Dan Dischner: Thank you, Paul. Good afternoon, and thanks for joining us for our second quarter earnings call of 2024. Joining me today will be Bill Peters, CFO and Executive Vice President of Finance, and Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations. It has now been over a year since the successful acquisition of Baximi, underscoring Amphastar's strategic focus on expanding our portfolio with proprietary products, biosimilars, and complex products. This quarter, Vaximi has emerged as a key driver, achieving impressive worldwide sales of $38.5 million for the quarter, representing a 10% increase compared to the same period last year and highlighting this product's growth.

Dan Dishner: Thank you, Paul. Good afternoon, and thanks for joining us for our second quarter earnings call of 2024. Joining me today will be Bill Peters, CFO, and Executive Vice President of Finance, and Tony Mars, Executive Vice President of Regulatory Affairs and Clinical Operations.

Paul Gander: Thank you Paul good afternoon, and thanks for joining us for our second quarter earnings call of 'twenty 'twenty four joining me today will be Bill Peters, CFO and executive Vice President of Finance and Tony Marrs Executive Vice President of regulatory affairs and clinical operations.

Dan Dischner: This revenue growth is strengthened by significant increases in sales of primatine mist and epinephrine, which have risen by 38% and 67% on an annualized basis respectively. Specifically, in-store sales of Primatine Mist have continued to show a growth trend, experiencing a 14% increase from Q2 of 2023. Remain confident in Primatine Mist's trajectory that it is on track to meet the 100 million sales target by the end of 2024.

Dan Dischner: This revenue growth is strengthened by significant increases in sales of primatine mist and epinephrine, which have risen by 38% and 67% on an annualized basis respectively. Specifically, in-store sales of Primatine Mist have continued to show a growth trend, experiencing a 14% increase from Q2 of 2023. Remain confident in its trajectory and that it is on track to meet the 100 million sales target by the end of 2024

Dan Dishner: It has now been over a year since the successful acquisition of Backfimmy, scoring Ampestar Strategic Focus on expanding our portfolio with proprietary products, biosimilars, and complex products. This quarter, that seeming has emerged as a key driver, achieving impressive worldwide sales of 38.5 million for the quarter, representing a 10 percent increase compared to the same period last year, and highlighting this product's growth. Overall, the quarter concluded with solid sales growth, driving total revenues to 182.4 million, representing an impressive 25 percent increase year over year. This revenue growth is strengthened by significant increases in sales of Primatene Mist and epinephrine, which have risen by 38 percent and 67 percent on an annualized basis, respectively.

Speaker Change: Now been over a year since the successful acquisition of vaccine me underscoring ample star strategic focus on expanding our portfolio with proprietary product Biosimilars and complex products.

Speaker Change: This quarter vaccine. He has emerged as a key driver achieving impressive worldwide sales of $38 5 million for the quarter, representing a 10% increase compared to the same period last year and highlighting this products growth.

Dan Dischner: Overall, the quarter concluded with solid sales growth, driving total revenues to $182.4 million, representing an impressive 25% increase year over year. This revenue growth is strengthened by significant increases in sales of primatine mist and epinephrine, which have risen by 38% and 67% on an annualized basis, respectively. Specifically, in-store sales of Primatine Mist have continued to show a growth trend, experiencing a 14% increase from Q2 of 2023.

Speaker Change: Overall, the quarter concluded with solid sales growth driving total revenue to $182 4 million, representing an impressive 25% increase year over year.

Speaker Change: This revenue growth is strengthened by significant increases in sales of prime attainment, and epinephrine, which have risen by 38% and 67% on an annualized basis respectively.

Dan Dishner: Specifically, in-store sales of Primatene Mist have continued to show a growth trend. Experiencing a 14 percent increase from Q2 of 2023, remain confident in Primatene Mist trajectory that it is on track to meet the 100 million sales target by the end of 2024.

Speaker Change: Specifically in store sales of private 10 minutes. The continued to show a growth trend experiencing a 14% increase from Q2 of 2023 remain confident and private teen Ms trajectory than it is on track to meet the 100 million sales target by the end of 'twenty 'twenty four.

Dan Dischner: I remain confident in Primatine Mist's trajectory and that it is on track to meet the 100 million sales target by the end of 2024. At our IMS facility, we have focused on enhancing efficiencies in the production of our epinephrine and other products, leading to increased capacity. These improvements have strategically positioned us to meet current and future market demands. Furthermore, our ongoing efficiency enhancements have significantly boosted our manufacturing capabilities without the need for additional square footage.

Dan Dishner: At our IMS facility, we have focused on enhancing efficiencies in the production of our epinephrine and other products, leading to increased capacity. These improvements have strategically positioned us to meet current and future market demands. Our ongoing efficiency enhancements have significantly boosted our manufacturing capabilities without the need of additional square footage. Furthermore, we believe that the recent approval of our albuterol product will improve our efficiencies at our Massachusetts manufacturing facility, where currently Primatene Mist is manufactured, optimizing our capacity utilization with another product, and a third one AMP007 on the horizon. Our glucagon injection sales have remained strong.

Dan Dischner: At our IMS facility, we have focused on enhancing efficiencies in the production of our epinephrine and other products, leading to increased capacity. These improvements have strategically positioned us to meet current and future market demands. Our ongoing efficiency enhancements have significantly boosted our manufacturing capabilities without the need of additional square footage.

Speaker Change: At our IMS facility, we have focus on enhancing efficiencies in the production of our epinephrine and other products leading to increased capacity. These improvements has strategically positioned us to meet current and future market demand.

Speaker Change: Our ongoing efficiency and Hammond enhancements have significantly boosted our manufacturing capabilities without the need of additional square footage.

Dan Dischner: Furthermore, we believe that the recent approval of our albuterol product will improve our efficiencies at our Massachusetts manufacturing facility, where currently primatine mist is manufactured, optimizing our capacity utilization with another product and a third one, AMP 007, on the horizon. Our glucagon injection sales have remained strong. However, we anticipate a decline from peak levels due to increased availability of competitor products in the diagnostic market.

Dan Dischner: Furthermore, we believe that the recent approval of our albuterol product will improve our efficiencies at our Massachusetts manufacturing facility, where currently primatine mist is manufactured, optimizing our capacity utilization with another product and a third one, AMP 007, on the horizon. Meanwhile, our glucagon injection sales have remained strong. However, we anticipate a decline from peak levels due to increased availability of competitor products in the diagnostic market. This trend aligns with our strategic focus on the diabetes sector, particularly with the emphasis on vaccinia.

Dan Dischner: Furthermore, we believe that the recent approval of our albuterol product will improve our efficiencies at our Massachusetts manufacturing facility, where currently primatine mist is manufactured, optimizing our capacity utilization with another product, and a third one, AMP 007, on the horizon. Our glucagon injection sales have remained strong. However, we anticipate a decline from the peak levels due to increased availability of competitor products in the diagnostic market.

Speaker Change: Furthermore, we believe that the recent approval of our albuterol product will improve our efficiencies at our Massachusetts manufacturing facility. We're currently prime a teen misses manufactured optimizing our capacity utilization with another product and a third one M. P 007 on the horizon.

Speaker Change: Our glucagon injection sales have remained strong however, we anticipate a decline from the peak levels due to increased availability of competitor products in the diagnostic market. This trend aligns with our strategic focus on the diabetes sector.

Dan Dishner: However, we anticipate a decline from the peak levels due to increased availability of competitor products in the diagnostic market. This trend aligns with our strategic focus on the diabetes sector, particularly with the emphasis of backseaming. We are dedicated to advancing our branded product strategy with backseaming, which presents significant opportunities in the retail market. The current underutilization of glucagon amongst diabetes combined with backseaming's advantages as an intranasal product positions us well for growth.

Dan Dischner: This trend aligns with our strategic focus on the diabetes sector, particularly with the emphasis of vaccine. We are dedicated to advancing our branded product strategy with Baxiami, which presents significant opportunities in the retail market. The current underutilization of glucagon amongst diabetics, combined with Baximi's advantages as an intranasal product, positions us well for growth.

Dan Dischner: This trend aligns with our strategic focus on the diabetes sector, particularly with the emphasis on Vaccinia. We are dedicated to advancing our branded product strategy with Baxiami, which presents significant opportunities in the retail market. The current underutilization of glucagon amongst diabetics, combined with Baximi's advantages as an intranasal product, positions us well for growth.

Speaker Change: Particularly with the emphasis of vaccine me.

Dan Dischner: We are dedicated to advancing our branded product strategy with Baxiami, which presents significant opportunities in the retail market. The current underutilization of glucagon amongst diabetics, combined with Baximi's advantages as an intranasal product, positions us well for growth.

Speaker Change: We are dedicated to advancing our branded product strategy with that Sami, which presents significant opportunities in the retail market. The current underutilization of glucagon amongst diabetics combined with vaccine. These advantages as an intranasal product positions us well for growth.

Dan Dishner: We want to briefly address the lawsuit filed by Teva on July 25. The lawsuit was filed with respect to Armstrong's approval or approved A&DA for generic albuterol. At the time of Teva's filing of this lawsuit, Armstrong had already received FDA approval for its A&DA, and we have launched the product. While we cannot comment further about the pending litigation, we are confident about our likelihood of prevailing against Teva. We will vigorously defend ourselves in this matter since we recognize the importance of providing patients with more access to affordable generic versions of albuterol inhalers.

Dan Dischner: We want to briefly address the lawsuit filed by Teva on July 25th. The lawsuit was filed with respect to Armstrong's approval or the approved ANDA for generic albuterol. At the time of Tebba's filing of this lawsuit, Armstrong had already received FDA approval for its ANDA, and we have launched the product. While we cannot comment further about the pending litigation, we are confident about our likelihood of prevailing against TEVA. We will vigorously defend ourselves in this matter since we recognize the importance of providing patients with more access to affordable generic versions of albuterol inhalers.

Dan Dischner: We want to briefly address the lawsuit filed by Teva on July 25th. The lawsuit was filed with respect to Armstrong's approval or approved ANDA for generic albuterol. At the time of Tebba's filing of this lawsuit, Armstrong had already received FDA approval for its ANDA, and we have launched the product. While we cannot comment further about the pending litigation, we are confident about our likelihood of prevailing against TEVA.

Speaker Change: We want to briefly address the lawsuit filed by tether on July 25th.

Speaker Change: The lawsuit was filed with respect to Armstrong's approval or approved Anda for generic albuterol at.

Speaker Change: At the time of tablets filing of this lawsuit Armstrong had already received FDA approval for its Anda and we have launched the product.

Speaker Change: While we cannot comment further about the pending litigation, we are confident about our likelihood of prevailing against Teva, we will vigorously defend ourselves in this matter since we recognize the importance of providing patients with more access to affordable generic versions of albuterol inhalers.

Dan Dischner: We will vigorously defend ourselves in this matter, since we recognize the importance of providing patients with more access to affordable generic versions of albuterol inhalers. Having now covered our key revenue drivers and significant events for the quarter, I would like to turn our attention to our pipeline and regulatory activities. On the topic of our filed ANDAs, we are engaged in positive and ongoing discussions with the FDA for AMP002, with anticipated progress in the near future.

Dan Dishner: Having now covered our key revenue drivers and significant events for the quarter, I would like to turn our attention to our pipeline and regulatory activities. On the topic of our filed A&DAs, we are engaged in positive and ongoing discussions with the FDA for AMP-002, with anticipated progress in the near future. For AMP-0015, our teraparitide A&DA, we have submitted our response to address the minor CRL and the FDA of the FDA. We have assigned the Gadufa gold date in the fourth quarter. Additionally, our second inhalation A&DA AMP-007 remains on track for a fourth quarter Gadufa gold date.

Dan Dischner: Having now covered our key revenue drivers and significant events for the quarter, I would like to turn our attention to our pipeline and regulatory activities. On the topic of our filed ANDAs, we are engaged in positive and ongoing discussions with the FDA for AMP002, with anticipated progress in the near future. For AMP015, our teriparatide ANDA, we have submitted our response to address the minor CRL, and the FDA has assigned the GDUFA goal date for the fourth quarter. Additionally, our second inhalation ANDA, AMP-007, remains on track for a four-quarter GDUFA gold.

Speaker Change: Having now covered our key revenue drivers and significant events for the quarter I would like to turn our attention to our pipeline and regulatory activities.

Dan Dischner: For AMP015, our teriparatide ANDA, we have submitted our response to address the minor CRL, and the FDA has assigned the GDUFA goal date in the fourth quarter. Additionally, our second inhalation ANDA, AMP-007, remains on track for a four-quarter GDUFA Gold Award.

Dan Dischner: On the topic of our filed ANDAs, we are engaged in positive and ongoing discussions with the FDA for AMP002, with anticipated progress in the near future. For AMP015, our teriparatide ANDA, we have submitted our response to address the minor CRL, and the FDA has assigned the GDUFA goal date in the fourth quarter. Additionally, our second inhalation ANDA, AMP-007, remains on track for a four-quarter GDUFA goal. With regard to our diabetes products, I am pleased to announce that we have filed our ANDA for AMP018, which is a generic GLP-1 product, and the FDA has accepted review with the GDUFID goal date in the second quarter of 2025. As for our BLA for Insulin APART, or AMP004, the product is expected to be refiled in the third quarter of 2024.

Speaker Change: On the topic of our filed Andas, we are engaged in positive and ongoing discussions with the FDA for M. P 002 with anticipated progress in the near future.

Speaker Change: For M. P 015, our Terra paratype Anda, we have submitted our response to address the minor C. R. L and the FDA has assigned the good group a goal date in the fourth quarter.

Speaker Change: Additionally, our second inhalation Anda M. P 007 remains on track for a fourth quarter. It could do for goal date.

Dan Dishner: With regards to our diabetes products, I am pleased to announce that we have filed our A&DA for AMP-0018, which is a generic GLP-1 product, and the FDA has accepted review of the Gadufa gold date in the second quarter of 2025. As for our BLA for insulin app part, or AMP-004, the product is expected to be refiled in the third quarter of 2024. In closing, I would like to note that AMP-004 is well positioned for a promising second half of 2024 with the potential for three significant product approvals: teraparitide AMP-0015, AMP-007, and AMP-002. These anticipate the approvals are expected to substantially contribute to our revenue growth and enhance our market presence.

Dan Dischner: With regards to our diabetes products, I'm pleased to announce that we have filed our ANDA for AMP018, which is a generic GLP-1 product, and the FDA has accepted review with the GDUFID goal date in the second quarter of 2025. As for our BLA for Insulin Aspart, or AMP004, the product is expected to be refiled in the third quarter of 2024. In closing, I'd like to note that Amphastar is well-positioned for a promising second half of 2024 with the potential for three significant product approvals. Teraparatide, AMP 015, AMP 007, and AMP 002.

Dan Dischner: With regard to our diabetes products, I am pleased to announce that we have filed our ANDA for AMP018, which is a generic GLP-1 product, and the FDA has accepted review with the GDUFID goal date in the second quarter of 2025. As for our BLA for Insulin Aspart, or AMP004, the product is expected to be refiled in the third quarter of 2024. In closing, I'd like to note that Amphastar is well-positioned for a promising second half of 2024 with the potential for three significant product approvals: Teraparatide, AMP 015, AMP 007, and AMP 002.

Speaker Change: With regards to our diabetes products I'm pleased to announce that we have filed our anda for M. P 018, which is a generic G. L. P. One product and the FDA has accepted review of the with a good do FID goal date in the second quarter of 'twenty 'twenty five.

Speaker Change: As for our BLA for insulin as part or a M. P zero zero for the product is expected to be re filed in the third quarter of 2024.

Speaker Change: In closing I'd like to note that Amp Istar is well positioned for a promising second half of 'twenty 'twenty four with the potential for three significant product approvals Terra paratype M. P 015, a M. P 007 and M. P zero zero to these.

Dan Dischner: Teraparatide, AMP 015, AMP 007, and AMP 008.

Dan Dischner: 007 and AMP 002. These anticipated approvals are expected to substantially contribute to our revenue growth and enhance our market presence. Our efforts to further strengthen our operational efficiencies and manufacturing capabilities will improve the foundation for transitioning from generics to higher-value products, including branded offerings, biosimilars, and complex products with significant barriers to entry. By continuing to optimize our resources while strategically advancing our product pipeline, along with our commitment to grow our current branded product offerings, Baccemium primatine mist, we are confident in our ability to drive long-term growth and deliver value. With that said, I would now like to turn the call over to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the second quarter's financial results. Thank you, Dan.

Dan Dischner: These anticipated approvals are expected to substantially contribute to our revenue growth and enhance our market presence. Our efforts to further strengthen our operational efficiencies and manufacturing capabilities will improve the foundation for transitioning from generics to higher value products including branded offerings, biosimilars, and complex products with significant barriers to entry. By continuing to optimize our resources while strategically advancing our product pipeline, along with our commitment to grow our current branded product offerings, Baccemium primatine mist, we are confident in our ability to drive long-term growth and deliver value. With that, I would now like to turn the call over to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the second quarter's financial results. Thank you, Dan.

Dan Dischner: These anticipated approvals are expected to substantially contribute to our revenue growth and enhance our market presence. Furthermore, our efforts to further strengthen our operational efficiencies and manufacturing capabilities will improve the foundation for transitioning from generics to higher-value products, including branded offerings, biosimilars, and complex products with significant barriers to entry. By continuing to optimize our resources while strategically advancing our product pipeline, along with our commitment to grow our current branded product offerings, Baccemium primatine mist, we are confident in our ability to drive long-term growth and deliver value. With that, I would now like to turn the call over to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the second quarter's financial results. Thank you, Dan.

Speaker Change: These anticipated approvals are expected to substantially contribute to our revenue growth in Manhattan, and enhance our market presence our efforts to further strengthen our operational efficiencies and manufacturing capabilities will improve the foundation for transitioning from generics to higher value products, including branded offerings Biosimilars.

Dan Dishner: Our efforts to further strengthen our operational efficiencies and manufacturing capabilities will improve the foundation for transitioning from generics to higher value products, including branded offerings, biosimilars, and complex products with significant barriers to entry. By continuing to optimize our resources while strategically advancing our product pipeline, along with our commitment to grow our current branded product offerings, Baximian Primatene Mist, we are confident in our ability to drive long-term growth and deliver value.

Speaker Change: And complex products with significant barriers to entry.

Speaker Change: By continuing to optimize our resources, while strategically advancing our product pipeline along with our commitment to grow our current branded product offerings back Simi and prime a teen missed we are confident in our ability to drive long term growth and deliver value.

William Peters: With that, I would now like to turn the call over to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the second quarter's financial results. Thank you, Dan. Revenues for the second quarter increase 25% to $102.4 million from $145.7 million in the previous year's period. Primatine missed sales grew 38% to $22.9 million in the second quarter from $16.5 million in the second quarter of last year. Remember that in the second quarter of last year we experienced a one-time inventory drawdown by retailers, which held back sales of Primatene Mist in that period. Epineference sales increased 67% to $27.9 million from $16.7 million due to other supplier shortages in the quarter.

Speaker Change: With that I would now like to turn the call over to our CFO and executive Vice President of Finance Bill Peters to discuss the second quarter's financial results.

Bill Peters: Revenues for the second quarter increased 25% to $182.4 million from $145.7 million in the previous year's period. Primatine Mist sales grew 38% to $22.9 million in the second quarter from $16.5 million in the second quarter of last year. Remember that in the second quarter of last year, we experienced a one-time inventory drawdown by retailers, which held back sales of Primatine Mist in that period. However, epinephrine sales increased 67% to $27.9 million from $16.7 million due to other supplier shortages in the quarter.

Bill Peters: Revenues for the second quarter increased 25% to $182.4 million from $145.7 million in the previous year's period. Primatine mist sales grew 38% to $22.9 million in the second quarter from $16.5 million in the second quarter of last year. However, remember that in the second quarter of last year, we experienced a one-time inventory drawdown by retailers, which held back sales of primatine mist in that period.

Bill Peters: Revenues for the second quarter increased 25% to $182.4 million, from $145.7 million in the previous year's period. Primatine mist sales grew 38% to $22.9 million in the second quarter, from $16.5 million in the second quarter of last year. Remember that in the second quarter of last year, we experienced a one-time inventory drawdown by retailers, which held back sales of primatine mist in that period. Epinephrine sales increased 67% to $27.9 million from $16.7 million due to other supplier shortages in the quarter.

Bill Peters: Thank you Dan.

Bill Peters: Revenues for the second quarter increased 25% to $182 $4 million from $145 $7 million in the previous year's period private team missed sales grew 38% to $22 $9 million in the second quarter from $16 $5 million in the second quarter of last year remember.

Speaker Change: That in the second quarter of last year, we experienced a one time inventory drawdown by retailers, which held back sales of primacy Miss in that period.

Bill Peters: Epinephrine sales increased 67% to $27.9 million from $16.7 million due to other supplier shortages in the quarter. Phytonodione sales decreased to $10.3 million from $17.9 million due to increased competition. Anoxaparin and Naloxone sales also saw a decline due to increased competition. Glucagon injection sales were flat as sales in Canada offset the decline in the United States during the quarter.

Bill Peters: Epinephrine sales increased 67% to $27 $9 million from $16 $7 million due do other supplier shortages in the quarter Phytonadione.

William Peters: Faiteno Dion sales decreased to $10.3 million from $17.9 million due to increased competition. Anoxoparent and naloxone sales also saw the declines due to increased competition. Google got injection sales reflect as sales in Canada offset the decline in the United States during the quarter. Other finished pharmaceutical products sales decreased to $34.7 million from $37.5 million, primarily due to a decrease in majority progesterum sales of $4.6 million due to the discontinuation of the API by our previous supplier, which has caused us to temporarily stop selling the finished product. This was partially offset by increased sales in other products such as dextrose and sodium bicarbonate.

Bill Peters: Phytonodione sales decreased to $10.3 million from $17.9 million due to increased competition. Anoxaparin and naloxone sales also saw a decline due to increased competition. Glucagon injection sales were flat, as sales in Canada offset the decline in the United States during the quarter.

Bill Peters: Phytonodione sales decreased to $10.3 million from $17.9 million due to increased competition. Anoxaparin and Naloxone sales also saw a decline due to increased competition. Glucagon injection sales were flat, as sales in Canada offset the decline in the United States during the quarter.

Bill Peters: If I turn a diode sales decreased to $10 $3 million from $17 $9 million due to increased competition.

Bill Peters: Enoxaparin and naloxone sales also saw declines due to increased competition.

Bill Peters: We got injection sales were flat as sales in Canada, offset the decline in the United States during the quarter.

Bill Peters: Other finished pharmaceutical product sales decreased to $34.7 million from $37.5 million, primarily due to a decrease in medroxyprogesterone sales of $4.6 million due to the discontinuation of the API by our previous supplier, which has caused us to temporarily stop selling the finished product. This was partially offset by increased sales in other products such as dextrose and sodium bicarbonate. Vaccine revenues fall into two categories as we begin shipping the product to the United States and a few European countries in the first quarter of this year. The first category relates to products we ship directly to our customers, for which we recorded net revenues of $30.9 million. These revenues are recorded in our Product Revenues Netline on the income statement.

Bill Peters: Other finished pharmaceutical product sales decreased to $34 7 million from $37 $5 million, primarily due to a decrease in medroxyprogesterone sales of $4 $6 million due to the discontinuation of the API by our previous supplier, which has caused us to temporarily stop selling the finished product.

Bill Peters: This was partially offset by increased sales in other products, such as dextrose and sodium bicarbonate.

William Peters: Vaccine revenues fall into two categories as we begin shipping the product in the United States in a few European countries in the first quarter of this year. The first category relates to products we ship directly to our customers, for which we recorded net revenues of $30.9 million. These revenues are recorded in our product revenues netline on the income statement. The second category relates to products sold by Lillian on our behalf under the Transition Service Agreement totaling $7.6 million, which had a cost of sales and expenses of $4.6 million. This resulted in net revenues of $3 million in our other revenues category, which corresponds to Amphusar's net economic benefit for vaccineing.

Bill Peters: Vaccine me revenues fall into two categories as we begin shipping the product United States in a few European countries in the first quarter of this year.

Bill Peters: The first category relates to products, we ship directly to our customers for which we recorded net revenues of $39 million.

Bill Peters: These revenues are recorded in our product revenues net line on the income statement.

Bill Peters: The second category relates to products sold by Lilly on our behalf under the Transition Service Agreement totaling $7.6 million, which had a cost of sales and expenses of $4.6 million. This resulted in net revenues of $3 million in our Other Revenues category, which corresponds to Amphastar's net economic benefit for vaccines. Total worldwide vaccine sales were $38.5 million for the quarter, up 10% from $34.9 million in sales reported by Lilly in the second quarter of 2023.

Bill Peters: The second category relates to products sold by Lilly on our behalf under the transition service agreement totaling $7 $6 million, which had a cost of sales and expenses of $4 $6 million.

Speaker Change: This resulted in net revenues of $3 million and our other revenues category, which corresponds to emphasize net economic benefit for Baxter Amy.

William Peters: Total worldwide vaccine sales worth $38.5 million for the quarter, up 10% from $34.9 million in sales reported by Lillian in the second quarter of 2023. We will continue to book revenues on a net revenue basis for those countries where Lillian continues to distribute the product on our behalf. For our own distribution of vaccine, we will increase throughout 2024 on a country basis based on local regulations as Lillian has wound down their inventory, and we have Amphusar label inventory available. This will result in an increase in product sales and a decline in the net economic benefit recognized in our other revenues.

Speaker Change: Total worldwide vaccine sales were $38 $5 million for the quarter up 10% from $34 $9 million in sales reported by Lilly and in the second quarter of 2023.

Bill Peters: We will continue to book revenues on a net revenue basis for those countries where Lilly continues to distribute the product on our behalf, but our own distribution of the vaccine will increase throughout 2024 on a country-by-country basis based on local regulations as Lilly has wound down its inventory and we have Amphastar label inventory available. This will result in an increase in product sales and a decline in the net economic benefit recognized in our other revenues.

Bill Peters: We will continue to book revenues on a net revenue basis for those countries where Lilly continues to distribute the product on our behalf, as our own distribution of the vaccine will increase throughout 2024 on a country-by-country basis based on local regulations, as Lilly has wound down its inventory, and we have Amphastar label inventory available. This will result in an increase in product sales and a decline in the net economic benefit recognized in our other revenues.

Bill Peters: We will continue to book revenues on a net revenue basis for those countries where Lilly continues to distribute the product on our behalf, for our own distribution of vaccine will increase throughout 2024 on a country-by-country basis based on local regulations as Lilly has wound down their inventory and we have Amphastar label inventory available. This will result in an increase in product sales and a decline in the net economic benefit recognized in our other revenues.

Bill Peters: We will continue to book revenues on a net revenue basis for those countries, where Lilly continues just to distribute the products on our behalf.

Speaker Change: For our own distribution of vaccine me will increase throughout 2024 on the country country by on a country by country basis based on the local regulations is literally has wound down their inventory and we have emphasis star labeled inventory available.

Speaker Change: This will result in an increase in product sales and a decline in the net economic benefit recognized in our other revenues.

William Peters: We would like to note that we just completed the first contract year of the five contract year period for potential milestone payments to Lillian. The four potential milestone payments are based on annual and cumulative five-year sales of vaccineing. Cumulative vaccine sales in the first quarter or the first year totaled $163.2 million, so none of these milestone payments for traders. Our informed API business had sales of $3.5 million, up from $2.8 million last year, as we have shipped RHI API to mankind for the last time until they have qualified our updated material. Cost of revenues increased to $87.2 million from $73 million, and gross margins improved to 52.2% from 49.9% in the previous year.

Bill Peters: We would like to note that we just completed the first contract year of the five-contract year period for potential milestone payments to Lilly. The four potential milestone payments are based on annual and cumulative five-year sales of the vaccine. Cumulative vaccine sales in the first quarter, or the first year, totaled $163.2 million. So none of these milestone payments were triggered.

Bill Peters: We would like to note that we just completed the first contract year of the five contract year period for potential milestone payments to Lilly. The four potential milestone payments are based on annual and cumulative five-year sales of vaccine, cumulative vaccine sales in the first quarter, or the first year, totaled $163.2 million. So none of these milestone payments were triggered.

Speaker Change: We would like to note that we just completed the first contract here of the five contract year period for potential milestone payments to Lilly.

Speaker Change: The four potential milestone payments based on annual and cumulative five year sales of vaccines.

Speaker Change: Humility that simi sales in the first quarter or the first year totaled $163 $2 million. So none of these milestone payments were triggered.

Bill Peters: Our insulin API business had sales of $3.5 million, up from $2.8 million last year as we shipped RHI to Mankind for the last time until they have qualified our updated material. Cost of revenues increased to $87.2 million from $73 million, and gross margins improved to 52.2% from 49.9% in the previous year. The benefit of increased sales of higher-margin products such as Baximi, primatine myths, and epinephrine will be partially offset by increased depreciation and amortization related to Baximi and increases in labor and certain component costs.

Bill Peters: Our insulin API business had sales of $3.5 million, up from $2.8 million last year, as we shipped RHI to Mankind for the last time until they have qualified our updated material. Cost of revenues increased to $87.2 million from $73 million, and gross margins improved to 52.2% from 49.9% in the previous year. The benefit of increased sales of higher-margin products such as Baximi, primatine myths, and epinephrine were partially offset by increased depreciation and amortization related to Baximi, and increases in labor and certain component costs.

Bill Peters: Our insulin API business had sales of $3.5 million, up from $2.8 million last year, as we have shipped RHI to, RHI API to Mankind for the last time until they have qualified our updated material. Cost of revenues increased to $87.2 million from $73 million and gross margins improved to 52.2% from 49.9% in the previous year. The benefit of increased sales of higher-margin products such as Baximi, primatine myths, and epinephrine will partially offset by increased depreciation and amortization related to Baximi and increases in labor and certain component costs.

Speaker Change: Our insulin API business had sales of $3 $5 million up from $2 $8 million last year as we have shipped our HIV.

Speaker Change: Our H I API to Mannkind for the last time until they have qualified our updated material.

Speaker Change: Yeah.

Speaker Change: Cost of revenues increased to $87 $2 million from $73 million and gross margins improved to 52, 2% from 49, 9% in the previous year the.

Operator: Greetings and welcome to the Amphastar Pharmaceuticals' second quarter earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone's your fire operator assistance during the conference, please press star zero on your telephone keypad. 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.

William Peters: The benefit of increased sales of higher margin products such as Baxime, Primativeness, and Epinephrine were partially offset by increased depreciation and memorization related to Baxime and increases in labor and certain component costs. Selling, distribution, and marketing expenses increased 34% to $9 million from $6.7 million in the previous year's period due to sales force expansion and marketing expenses related to Baxime. General and administrative spending increased 8% to $13.3 million from $12.3 million, primarily due to increased expenses related to Baxime. Research and development expenditures increased 5% to $17.7 million from $16.8 million due to an increase in salary and personal related expenses, as well as the ANDA filing fee for AMP 018.

Speaker Change: The benefit of increased sales of higher margin products, such as vaccine me privacy missed an epinephrine and were partially offset by increased depreciation and amortization related to vaccine me and increases in labor and certain component costs.

Bill Peters: Selling, distribution, and marketing expenses increased 34% to $9 million from $6.7 million in the previous year's period due to sales force expansion and marketing expenses related to the vaccine. General and administrative spending increased 8% to $13.3 million from $12.3 million, primarily due to increased expenses related to vaccine agents. Research and development expenditures increased 5% to $17.7 million from $16.8 million due to an increase in salary and personnel-related expenses as well as the ANDA filing fee for AMP 018. These increases were partially offset by decreases in clinical trial expenses due to the timing of clinical trials.

Bill Peters: Selling, distribution, and marketing expenses increased 34% to $9 million from $6.7 million in the previous year's period due to sales force expansion and marketing expenses related to vaccine, General and administrative spending increased 8% to $13.3 million from $12.3 million, primarily due to increased expenses related to vaccine. Research and development expenditures increased 5% to $17.7 million from $16.8 million due to an increase in salary and personnel-related expenses, as well as the ANDA filing fee for AMP 018. These increases were partially offset by decreases in clinical trial expenses due to the timing of clinical trials.

Bill Peters: Selling, distribution, and marketing expenses increased 34% to $9 million from $6.7 million in the previous year's period due to sales force expansion and marketing expenses related to the vaccine. General and administrative spending increased 8% to $13.3 million from $12.3 million, primarily due to increased expenses related to the vaccine. Research and development expenditures increased 5% to $17.7 million from $16.8 million due to an increase in salary and personnel-related expenses as well as the ANDA filing fee for AMP 018.

Speaker Change: Selling distribution and marketing expenses increased 34% to $9 million from $6 $7 million in the previous year's period due to sales force expansion and marketing expenses related to vaccines.

Operator: These statements are based solely on information that is now available to us. We encourage you to review this section entitled Forward-looking Statements in the press release issued today in the presentation on the company's website. Also, please refer to our SEC violence, 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-gap measures. Important information on our use of these measures and recommendations to US Gap may be found in our earnings release. Please note this conference is being recorded.

Speaker Change: General and administrative spending increased 8% to $13 $3 million from $12 $3 million, primarily due to increased expenses related to vaccine me.

Speaker Change: Research and development expenditures increased 5% to $17 $7 million from $16 $8 million due to an increase in salary and personnel related expenses as well as the anda filing fee for E&ps 018.

William Peters: These increases were partially offset by decreasing and decreases in clinical trial expenses due to the timing of clinical trials. Non-operating expenses increased to $5 million from $4.1 million, primarily driven by increased interest expense on loans associated with the acquisition of Baxime. Net income increased 45% to $37.9 million, or $0.73 cents per share, in the second quarter from $26.1 million, or $0.49 cents per share, in the second quarter of 2023. Adjusted net income increased to $48.7 million, or 94 cents per share, compared to an adjusted net income of $34.8 million, or 65 cents per share, in the second quarter of last year.

Speaker Change: These increases were partially offset by decreasing and decreases in clinical trial expenses due to the timing of clinical trials.

Operator: Our speakers today are Mr. Bill Peters, CFO, Mr. Dan Dishner, Senior Vice President of Corporate Communications and Mr. Tony Mars, Executive Vice President of Regulatory Affairs and Clinical Operations.

Bill Peters: Non-operating expenses increased to $5 million from $4.1 million, primarily driven by increased interest expense on loans associated with the acquisition of vaccine makers. Net income increased 45% to $37.9 million or $0.73 per share in the second quarter from $26.1 million or $0.49 per share in the second quarter of 2023. Adjusted net income increased to $48.7 million, or $0.94 per share, compared to an adjusted net income of $34.8 million, or $0.65 per share, in the second quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets, and one-time events.

Bill Peters: Non-operating expenses increased to $5 million from $4.1 million, primarily driven by increased interest expense on loans associated with the acquisition of vaccine. Net income increased 45% to $37.9 million or $0.73 per share in the second quarter from $26.1 million or $0.49 per share in the second quarter of 2023. Adjusted net income increased to $48.7 million, or $0.94 per share, compared to an adjusted net income of $34.8 million, or $0.65 per share, in the second quarter of last year.

Speaker Change: Non operating expenses increased to $5 million from $4 $1 million, primarily driven by increased interest expense on loans associated with the acquisition of vaccine me.

Dan Dishner: I'll now turn the call over to your host, Mr. Dan Dishner, Senior Vice President of Corporate Communications. Dan, may be in. Thank you, Paul.

Bill Peters: These increases were partially offset by decreases in clinical trial expenses due to the timing of clinical trials. Non-operating expenses increased to $5 million from $4.1 million, primarily driven by increased interest expense on loans associated with the acquisition of vaccine materials. Net income increased 45% to $37.9 million, or $0.73 per share, in the second quarter, from $26.1 million, or $0.49 per share. In the second quarter of 2023, adjusted net income increased to $48.7 million, or $0.94 per share, compared to an adjusted net income of $34.8 million, or $0.65 per share, in the second quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets, and one-time events.

Speaker Change: Net income increased 45% to $37 $9 million or <unk> 73 per share in the second quarter from $26 $1 million or 49 cents per share in the second quarter of 2023.

Dan Dishner: Good afternoon, and thanks for joining us for our second quarter earnings call of 2024. Joining me today will be Bill Peters, CFO, and Executive Vice President of Finance and Tony Mars, Executive Vice President of Regulatory Affairs and Clinical Operations. It has now been over a year since the successful acquisition of Backfimmy, scoring Ampestar Strategic Focus on expanding our portfolio with proprietary products, biosimlers, and complex products. This quarter, that seeming has emerged as a key driver, achieving impressive worldwide sales of 38.5 million for the quarter, representing a 10 percent increase compared to the same period last year, and highlighting this product's growth.

Speaker Change: Adjusted net income increased to $48 $7 million or <unk> 94 per share compared to an adjusted net income of $34 $8 million or 65 cents per share in the second quarter of last year.

William Peters: Adjusted earnings exclude amortization, equity compensation, impairments of loan with assets in one-time events. In the second quarter, we had cash flow from operations of approximately $69.1 million. During the quarter, we made the required $129 million payment to the lease for the Baxime acquisition. In addition, we used the portion of our cash to buy back $8.5 million worth of shares and to pay down the mortgage for $8 million.

Bill Peters: Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets, and one-time events. In the second quarter, we had cash flow from operations of approximately $69.1 million. During the quarter, we made the required $129 million payment to Lilly for the vaccine acquisition. In addition, we used a portion of our cash to buy back $8.5 million worth of shares and to pay down a mortgage for $8 million.

Speaker Change: Adjusted earnings exclude amortization equity compensation impairments of long lived assets and one time events.

Bill Peters: In the second quarter, we had cash flow from operations of approximately $69.1 million. During the quarter, we made the required $129 million payment to Lilly for the Vaccini Acquisition. In addition, we used a portion of our cash to buy back $8.5 million worth of shares and to pay down a mortgage for $8 million. I will now turn the call back over to Dan. Thank you, Bill, for the update. With that, we will now take your questions. Operator, please open the line for Q&A.

Speaker Change: In the second quarter, we had cash flow from operations of approximately $69 $1 million during the quarter, we made the required $129 million payment to Lilly for the vaccine the acquisition.

Dan Dishner: Overall, the quarter concluded with solid sales growth, driving total revenues to 182.4 million, representing an impressive 25 percent increase year over year. This revenue growth is strengthened by significant increases in sales of primatine mist and epinephrine, which have risen by 38 percent and 67 percent on an annualized basis respectively. Specifically, in-store sales of primatine mist have continued to show a growth trend. Experiencing a 14 percent increase from Q2 of 2023, remain confident in primatine mist trajectory that it is on track to meet the 100 million sales target by the end of 2024.

Speaker Change: In addition, we used a portion of our cash to buy back $8 $5 million worth of shares and to pay down our mortgage for $8 million.

Dan Dishner: I will now turn the call back over to Dan. Thank you, Bill, for the update. With that, we will now take your questions.

Dan Dischner: I will now turn the call back over to Dan. Thank you, Bill, for the update. With that, we will now take your questions. Operator, please open the line for Q&A. Thank you. We'll now be conducting a question and answer session.

Dan Dischner: I will now turn the call back over to Dan. Thank you Bill for the update. With that, we will now take your questions. Operator, please open the line for Q&A. Thank you. We'll now be conducting a question and answer session.

Speaker Change: I'll now turn the call back over to Dan.

Dan: Thank you Bill for the update with that we will now take your questions. Operator. Please open the line for Q&A.

Operator: Operator, please open the line for Q&A. Thank you. We'll now be conducting an question and answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation telephone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your hand step before pressing the star keys. One moment, please, while we pull for questions. Thank you.

Operator: Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker Change: Thank you well now be conducting a question and answer session.

Speaker Change: Okay.

Operator: If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tome will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker Change: I'd like to ask a question. Please press star one on your telephone keypad.

Speaker Change: A confirmation tone will be King your line is in the question queue.

Speaker Change: Press Star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.

Operator: One moment, please, while we poll for questions. Thank you. Our first question is from Ekaterina Knyazkova with J.P. Morgan. Please proceed with your question.

Operator: One moment, please, while we poll for questions. Thank you. Our first question is from Ekaterina Knyazkova with J.P. Morgan. Please proceed with your question. Hi, thank you so much. Just two from me, if I may.

Operator: One moment, please, while we poll for questions. Thank you. Our first question is from Ekaterina Knyazkova with J.P. Morgan. Please proceed with your question.

Speaker Change: One moment, please while we poll for questions.

Dan Dishner: At our IMS facility, we have focused on enhancing efficiencies in the production of our epinephrine and other products, leading to increased capacity. These improvements have strategically positioned us to meet current and future market demands. Our ongoing efficiency enhancements have significantly boosted our manufacturing capabilities without the need of additional square footage. Furthermore, we believe that the recent approval of our albuterol product will improve our efficiencies at our Massachusetts manufacturing facility, where currently primatine mist is manufactured, optimizing our capacity utilization with another product, and a third one AMP007 on the horizon.

Speaker Change: Thank you. Our first question is from EQECAT Arena, Nicola with J P. Morgan. Please proceed with your question.

Ike Dorena: Our first question is from Ike Dorena, Nia Kova, with J.P. Morgan. Please proceed with your question. Hi. Thank you so much. Just two from me, if I may. So first, just an epinephrine seems like another very strong quarter for the product.

Ekaterina Knyazkova: Hi, thank you so much. Just two from me, if I may.

unknown: So first, just an epinephrine seems like another very strong order for the product. Can you just maybe talk about expectations for that franchise over time, both from a competitor supply shortage standpoint, if you're seeing any changes there, as well as with potentially other players either entering or filing an application in that market? And then the second question is generic pro-air. Can you just help us frame how you're thinking about the size of that opportunity and how quickly you can launch, as soon as you decide to do so, and how quickly you can, I guess, get uptake for that product? Thank you so much. So for the Epi, we do have, you know, we have two different presentations for that product. First of all, there is a multi-dose vial and a pre-filled syringe.

Nicola: Hi, Thank you so much just two for me if I may so.

Dan Dischner: So first, just an epinephrine seems like another very strong order for the product. Can you just maybe talk about expectations for that franchise over time, both from a competitor supply shortage standpoint, if you're seeing any changes there, as well as with potentially other players either entering or filing an application in that market? And then the second question is generic pro-air. Can you just help us frame how you're thinking about the size of that opportunity and how quickly you can launch, as soon as you decide to do so, and how quickly you can, I guess, get uptake for that product? Thank you so much. So for

Speaker Change: So first just a preference seems like another very strong quarter for the product, but can you just need to talk about expectations for that franchise over time, both from a competitor supply shortages standpoint, if you're seeing any changes there as long as with potentially other players either entering or filing an.

Ike Dorena: Can you just maybe talk about acceptations for that franchise over time, both from a competitor or supply shortage standpoint, if you're seeing any changes there, as well as potentially other players either entering or filing an application in that market?

Nicola: An application in that market and then just second question is on generic pro Air can you just help us frame, how youre thinking about the size of that opportunity and how quickly you can launch them and as.

Ike Dorena: And then just second question is generic pro-air. Can you just help us frame how you're thinking about the size of that opportunity, and how quickly you can launch an SMZ decided to do so, and how quickly you can, I guess, get uptake for that product. Thank you so much. So for the epi, we do have, you know, we have two different presentations for that product. First of all, those multi-dose file and a pre-filled syringe. And the pre-filled syringe has been on the drug shortage supply list for almost a year now, or about a year now, based on a hurricane that has hit one of our competitors.

Dan Dishner: Our glucagon injection sales have remained strong. However, we anticipate a decline from the peak levels due to increased availability of competitor products in the diagnostic market. This trend aligns with our strategic focus on the diabetes sector, particularly with the emphasis of backseaming. We are dedicated to advancing our branded product strategy with backseaming, which presents significant opportunities in the retail market. The current underutilization of glucagon amongst diabetes combined with backseaming's advantages as an intranasal product positions us well for growth.

Speaker Change: As soon as he decides to do so and how quickly you can I guess get uptake for that product well. Thank you so much.

Nicola: Yeah.

Dan Dischner: So, for the Epi, we do have, you know, we have two different presentations for that product. First of all, there's a multi-dose vial and a pre-filled syringe, and the pre-filled syringe has been on the drug shortage supply list for almost a year now, or about a year now, based on a hurricane that hit one of our competitors.

Speaker Change: So for the F. B, we do have you know we have two different presentations for that product first of all of those are multi dose vial in a prefilled syringe and the pre filled syringe has been on.

unknown: And the pre-filled syringe has been on the drug shortage supply list for almost a year now, or about a year now, based on a hurricane that hit one of our competitors. So that portion of the business has remained relatively robust. However, as Dan mentioned in his comments, what we've done is we've taken some steps to increase the capacity of that plant by increasing some of the efficiency of some of the labor and the different packaging steps.

Speaker Change: Drug shortage supply list for almost a year now we're about a year now based on the Hurricanes that hit one of our competitors. So that that portion of the business has remained relatively robust. However, as Dan had mentioned it in his comments what we've done is we've taken some steps to increase the capacity.

Dan Dischner: So that portion of the business has remained relatively robust. However, as Dan mentioned in his comments, what we've done is we've taken some steps to increase the capacity of that plant by increasing some of the efficiency of some of the labor and the different packaging steps. So we've been able to increase the production of that product and pump out more sales, as we showed this quarter. So we do expect that that shortage for that product will be, you know, we're seeing from the competitors that they're going to start returning to the market in the fourth quarter now. I think last quarter they said it was the third quarter.

Dan Dishner: So that portion of the business has remained relatively robust. However, as Dan had mentioned in his comments, what we've done is we've taken some steps to increase the capacity of that plant by increasing some of the efficiency of some of the labor and the different packaging steps. So we've been able to increase the production of that product and pump out more sales, as we showed this quarter. So we do expect that shortage for that product will be, you know, we're seeing from the competitor that they're gonna start returning to the market in the fourth quarter now.

Dan: City of that plant by increasing some of the efficiencies from the labor and the different fill out the different packaging steps. So we've been able to increase the production of that product in and pump out more sales as we as we showed this quarter. So we do expect that that shortage for that product will be.

unknown: So we've been able to increase the production of that product and pump out more sales, as we showed this quarter. So we do expect that that shortage for that product will be, you know, we're seeing from the competitors that they're going to start returning to the market in the fourth quarter now. I think last quarter they said the third quarter.

Dan Dishner: While we cannot comment further about the pending litigation, we are confident about our likelihood of prevailing against Teva. We will vigorously defend ourselves in this matter since we recognize the importance of providing patients with more access to affordable generic versions of albuterol inhalers.

Speaker Change: Where we're seeing from the competitor that theyre going to start returning to the market in the fourth quarter now I think last quarter. They said the third quarter. This quarter was the same in the fourth quarter, so, but returning to a regular supply sometime next year. So yeah.

Dan Dishner: I think last quarter, they said the third quarter; this quarter is saying the fourth quarter, so but returning to a regular supply sometime next year. So, you know, it's hard to say exactly, but, you know, right now we're just preparing ourselves to make sure that we can take advantage of this and we can supply as much as needed to the industry.

Dan Dischner: This quarter, they're saying the fourth quarter, but returning to a regular supply sometime next year. So, you know, it's hard to say exactly, but, you know, right now, we're just preparing ourselves to make sure that we can take advantage of this, and we can supply as much as needed to the industry. As far as the multi-dose vial is concerned, there is a new competitor to that one out there, so we do expect that the sales of that presentation will drop somewhat as the market has gone from two to three suppliers.

Dan Dishner: Having now covered our key revenue drivers and significant events for the quarter, I would like to turn our attention to our pipeline and regulatory activities. On the topic of our filed A&DAs, we are engaged in positive and ongoing discussions with the FDA for AMP-002 with anticipated progress in the near future. For AMP-0015, our teraparitide A&DA, we have submitted our response to address the minor CRL and the FDA of the FDA. We have assigned the Gadufa gold date in the fourth quarter.

unknown: This quarter they're saying the fourth quarter but returning to a regular supply sometime next year. So, you know, it's hard to say exactly, but, you know, right now, we're just preparing ourselves to make sure that we can take advantage of this, and we can supply as much as needed. As far as the multi-dose file, there is a new competitor for that one out there, so we do expect that the sales of that presentation will drop somewhat as the market has gone from two to three suppliers. Yeah, on the generic pro-air, as we mentioned in the call, we have launched the product, so we've already got it out there.

Dan: It's hard to say exactly but you know right now where we're just preparing ourselves to make sure that we can take advantage of this and we can supply as much as needed to the to the industry as far as the multi dose file there is a new competitor to that one out there. So we do expect that the sales of that presentation will.

Dan Dishner: As far as the multi-dose file, there is a new competitor to that one out there, so we do expect that the sales of that presentation will drop somewhat as the market has gone from two to three suppliers. Yeah, on the generic pro-air, as we mentioned in the call, we have launched the product, so we've already got it out there. Where we're going with that, you know, obviously there are other competitors in the market, and we're still working on securing business there. So, right now I don't know that we're really have a good idea, but it's been received well so far, so hopefully we'll be able to give an update a better update later.

Dan: Dropped somewhat as as the market has gone from two to three mm suppliers.

Dan Dishner: Additionally, our second inhalation A&DA AMP-007 remains on track for a fourth quarter Gadufa gold date. With regards to our diabetes products, I am pleased to announce that we have filed our A&DA for AMP-0018, which is a generic GLP-1 product, and the FDA has accepted review of the Gadufa gold date in the second quarter of 2025. As for our BLA for insulin app part, or AMP-004, the product is expected to be refiled in the third quarter of 2024.

Dan Dischner: Yeah, on the generic pro-air, as we mentioned in the call, we have launched the product, so we've already got it out there. Where we're going with that, you know. Obviously, there are other competent competitors in the market, and we're still working on securing business there. So I, right now, I don't know that we really have a good idea, but it's been received well so far, so hopefully we'll be able to give an update, a better update, later.

Dan: Yeah.

Dan: On the generic pro are as we mentioned in the call. We have launched the product. So we've already got it out there.

unknown: Where we're going with that is, you know, obviously, there are other competent competitors in the market, and we're still working on securing business there. So I, right now, I don't know that we really have a good idea, but it's been received well so far, so hopefully we'll be able to give an update, a better update, later. And one of the things with that one is that we're increasing the capacity of the packaging over time, so we might be off to, I don't want to say it, a more moderate start, but then we expect to increase that, the ability to meet the demand for that product over the course of the next year. Thank you. I appreciate it.

Dan: Where we're going with that is you know obviously there are other competitors in the market and we're still working on securing our business. There. So right now I don't know that we're really.

Dan: Have a good idea, but we it's been received well so far so hopefully we'll be able to give an update a better update later and one of the things with that one is that where we.

Dan Dishner: And one of the things with that one is that we're increasing the capacity of the packaging over time, so we might be off to, I don't want to say a more moderate start, but then we expect to increase that ability to meet the demand for that product over the course of the next few quarters, right? Thank you; I appreciate it.

Dan Dischner: And one of the things with that one is that we're increasing the capacity of the packaging over time, so we might be off to, I don't want to say, a more moderate start, but then we expect to increase the ability to meet the demand for that product over the course of the next few quarters. Thank you.

Dan Dishner: In closing, I would like to note that AMP-004 is well positioned for a promising second half of 2024 with the potential for three significant product approvals, teraparitide AMP-0015, AMP-007 and AMP-002. These anticipate the approvals are expected to substantially contribute to our revenue growth and enhance our market presence. Our efforts to further strengthen our operational efficiencies and manufacturing capabilities will improve the foundation for transitioning from generics to higher value products, including branded offerings, biosimlers, and complex products with significant barriers to entry.

Dan: We're increasing the capacity of the the packaging over time so.

Speaker Change: We might be off to I don't want to say it.

Dan: A more moderate start, but then we expect to increase that the ability to meet the demand for that product over the course of next few quarters right.

Speaker Change: Thank you appreciate it.

Speaker Change: Okay.

Operator: Thank you. Our next question is from David Amsellem with Piper Sandler. Please proceed with your question. Thanks. I've got a couple of pipeline questions. So, I know 002 has kind of been beaten over the head, but is there anything new that you could add regarding your interactions with the FDA or, more specifically, what they're hung up on? That's number one. Number two, on the GLP-1, just remind us, is that a P4 or a P3? Is that a litigated filing?

David Amsalem: Thank you. Our next question is from David Amsalon with Piper Sandler. Please proceed with your question. Thanks. Got a couple of pipeline questions.

David Amsellem: Thank you. Our next question is from David Amsellem with Piper Sandler. Please proceed with your question.

David <unk>: Thank you. Our next question is from David <unk> with Piper Sandler. Please proceed with your question.

Dan Dischner: Thanks. I've got a couple of pipeline questions. So, I know 002 has kind of been beaten over the head, but is there anything new that you could add regarding your interactions with the FDA or, more specifically, what they're hung up on? That's number one. Number two, on the GLP-1, just remind us, is that a P4 or a P3? Is that a contested filing? And is there already generic competition, or do you anticipate that there will be others when you're in a position to launch? So, that's number two. And then number three, on 017, a similar kind of question. Is that a P4? Is that going to be a litigated filing? And talk about the nature of competition in that market? Thanks.

David <unk>: So got a couple of pipeline questions. So I.

David Amsalem: I know 002 has been beaten over the head, but is there anything new that you could add regarding your interactions with the FDA, or more specifically what they're hung up on? That's number one, number two on the GLP-1. Just to remind us, is that P4 or a P3? Is that a litigated filing, and is there already generic competition, or do you anticipate that there will be others when you're in a position to launch? So that's number two.

David <unk>: I know zero-zero who's kind of been beaten over the head, but is there anything new that you could add regarding your interactions with the FDA or more specifically what they are hung up on that's number one number two on the G. L. P. One just remind us is that PV.

Dan Dishner: By continuing to optimize our resources while strategically advancing our product pipeline, along with our commitment to grow our current branded product offerings, Baximian primatine mist, we are confident in our ability to drive long-term growth and deliver value.

unknown: And is there already generic competition, or do you anticipate that there will be others when you're in a position to launch? So, that's number two. And then number three, on 017, a similar kind of question. Is that a P4?

Bill Peters: With that, I would now like to turn the call over to our CFO and Executive Vice President of Finance Bill Peters to discuss the second quarter's financial results. Thank you, Dan. Revenues for the second quarter increase 25% to $102.4 million from $145.7 million in the previous year's period. Primatine missed sales grew 38% to $22.9 million in the second quarter from $16.5 million in the second quarter of last year. Remember that in the second quarter of last year we experienced a one-time inventory drawdown by retailers which held back sales of primatine missed in that period.

David <unk>: Or or a P threes that are litigated filing.

Speaker Change: And is there already.

Speaker Change: Generic competition or do you anticipate that there will be others.

Speaker Change: When youre in a position to launch them. So that's number two and then number three on <unk> seven.

David Amsalem: And then number three on 017. Similar kind of question, is that a P4? Is that going to be a litigated filing, and talk about the nature of competition in that market? Thanks. Yeah, for MP002, we continue to have routine conversations with the agency. The last conversations we've had have been, and I guess maybe stepping back, the idea is just to kind of get a sense of what they're doing and the progress that they're making for the issue. We think we understand what their issue is, and based on those conversations, we feel that they're coming to an end to be able to resolve their issue.

Speaker Change: Kind of question is that a pea for is that going to be a litigated filing.

David <unk>: And talk about the nature of competition.

David <unk>: In that market. Thanks.

David <unk>: Okay.

unknown: Is that going to be a litigated filing? And talk about the nature of competition in that market? Thanks. Yeah, for AMP002, we continue to have routine conversations with the agency. The last conversations we've had have been, and I guess maybe stepping back, the idea is just to kind of get a sense of what they're doing and the progress that they're making on the issue. We think we understand what their issue is, and based on those conversations, we feel that they are coming to an end to be able to resolve their issue.

Dan Dischner: Yeah, for AMP002, we continue to have routine conversations with the agency. The last conversations we've had have been, and I guess maybe stepping back, the idea is just to kind of get a sense of what they're doing and the progress that they're making on the issue. We think we understand what their issue is, and based on those conversations, we feel that they're coming to an end to be able to resolve their issue.

Speaker Change: Yeah, four four M. P 002, we continue to have routine conversations with the agency.

Bill Peters: Epineference sales increased 67% to $27.9 million from $16.7 million due to other supplier shortages in the quarter. Faiteno Dion sales decreased to $10.3 million from $17.9 million due to increased competition. Anoxoparent and Naloxone sales also saw the declines due to increased competition. Google got injection sales reflect as sales in Canada offset the decline in the United States during the quarter. Other finished pharmaceutical products sales decreased to $34.7 million from $37.5 million primarily due to a decrease in majority progesterum sales of $4.6 million due to the discontinuation of the API by our previous supplier which has caused us to temporarily stop selling the finished product.

Speaker Change: And the last conversations we've had has had been and I guess, maybe stepping back. The idea is just to kind of get a sense of what they're doing and the progress that they're making for the issue. We think we understand what their issue is.

Speaker Change: And based on those conversations we feel that they're coming to an end to be able to resolve their issue.

Dan Dishner: And so, based on those calls that we routinely have with them, is why we feel that we believe it'll be a newer future that they'll take action on the application. For the AMP018, the GLP, it is a paragraph four filing on that product. And we're still within the period of time where we have not been sued to date, but we still could be, and that we do expect competition on this one when we're in a position to launch the product. And AMP007, that is a paragraph four filing as well. And you expect competition? It's hard to say at this point.

Dan Dischner: And so based on those calls that we routinely have with them, it's why we feel that it'll be in the near future that they'll take action on the application. For AMP018, GLP, it is a paragraph 4 filing on that product. And we're still within the period of time where we have not been sued to date, but we still could be. And we do expect competition on this one when we're in a position to launch the product, and AMP007, that is a paragraph for filing as well.

unknown: And so based on those calls that we routinely have with them, it's why we feel that it'll be in the near future that they'll take action on the application. For AMP018, GLP, it is a paragraph 4 filing on that product.

Speaker Change: And so based on those calls that we routinely have with that and it is why we feel that we believe it'll be at near future that they'll they'll take action on the application.

Speaker Change: For the a M. P 018 am did G. L. P. It is a paragraph four filing on that product.

Bill Peters: This was partially offset by increased sales in other products such as Dextrose and sodium bicarbonate. Vaccine revenues fall into two categories as we begin shipping the product in the United States in a few European countries in the first quarter of this year. The first category relates to products we ship directly to our customers for which we recorded net revenues of $30.9 million. These revenues are recorded in our product revenues netline on the income statement.

unknown: And we're still within the period of time where we have not been sued to date, but we still could be. And we do expect competition on this one when we're in a position to launch, and AMP007 is a paragraph for filing as well. And do you expect competition? It's hard to say at this point.

Speaker Change: And we're still within the period of time, where we have not been sued to date, but we still could be and that we do expect competition on this one when we're in a position to launch the product.

Speaker Change: And a M. P 007 that is a paragraph four filing as well.

Dan Dischner: And do you expect competition?

Speaker Change: And do you expect competition.

Dan Dischner: It's hard to say at this point, but we'd rather not say at this point. All right, fair enough.

Speaker Change: It's hard to say at this point.

Bill Peters: The second category relates to products sold by Lillian on our behalf under the Transition Service Agreement totaling $7.6 million which had a cost of sales and expenses of $4.6 million. This resulted in net revenues of $3 million in our other revenues category which corresponds to Amphusar's net economic benefit for vaccineing. Total worldwide vaccine sales worth $38.5 million for the quarter up 10% from $34.9 million in sales reported by Lillian in the second quarter of 2023.

Dan Dishner: We'd rather not say at this point. All right, fair enough, thanks.

unknown: We'd rather not say. All right, fair enough. Thanks. Thank you. Thank you.

Speaker Change: Yeah, we'd rather not say at this point.

Dan Dischner: All right. Fair enough.

Speaker Change: Alright fair enough. Thanks.

Dan Dishner: Thanks. Thank you.

Speaker Change: Thanks.

Speaker Change: Yeah.

Operator: Our next question is from Jason Gerberry with Bank of America. Please proceed with your question. Hey guys, thank you for taking my questions. Two for me.

Jason Gerberry: Thank you. Our next question is from Jason Gerberry with Bank of America. Please proceed with your question.

Speaker Change: Thank you. Our next question is from Jason <unk> with Bank of America. Please proceed with your question.

Jason Gerber: Our next question is from Jason Gerber with Bank of America. Thanks for being with your question. Hey, guys. Thank you for taking my questions. Two for me. First with Beck-Simmy, you know, as long as presumably it's going to curl in the second half. This overall company grows margins. Second half was first half. We saw a little bit of margin degradation in 2Q versus 1Q. So just wondering how we think about the impact of mix and more Beck-Simmy in the revenues dropping to the growth profit line. And then on business development, wondering how you're thinking about that as something that might kick start your goal of getting to pipeline 50% proprietary programs by next year versus using BD more as a tool to maybe add a complementary market-ready asset like Beck-Simmy.

Dan Dischner: You guys, thank you for taking my questions, too, for me. First, with Beximi, you know, as long as presumably it's going to grow in the second half, we could. Overall company gross margins, second half versus first half, you know, we saw a little bit of margin degradation in 2Q versus 1Q. So, just wondering how we think about the impact of mix and more back semi in the revenues dropping to the gross profit line.

Jason: Hey, guys. Thank you for taking my questions two for me.

unknown: First, with Beximi, you know, as long as, presumably, it's going to grow in the second half of the year. Overall company gross margins, second half versus first half, we saw a little bit of margin degradation in 2Q versus 1Q. So just wondering how we think about the impact of mix and more back semi in revenues dropping to the gross profit line. And then on business development, I'm wondering how you're thinking about that as something that might kickstart your goal of getting to pipeline 50% proprietary programs by next year versus using BD more as a tool to maybe add a complementary market-ready asset like back semi.

Jimmy: First with Jimmy.

Speaker Change: You know as long as presumably it's going to grow in the second half.

Speaker Change: This.

Speaker Change: Overall company gross margins second half versus first half, we saw a little bit of margin degradation in <unk> versus <unk>. So just wondering how we think about the impact of mix and more back to Jimmy.

Bill Peters: We will continue to book revenues on a net revenue basis for those countries where Lillian continues to distribute the product on our behalf. For our own distribution of vaccine we will increase throughout 2024 on a country basis based on local regulations as Lillian has wound down their inventory and we have Amphusar label inventory available. This will result in an increase in product sales and a decline in the net economic benefit recognized in our other revenues.

Speaker Change: And the revenues are dropping to the gross profit line and then.

Speaker Change: On business development, I'm wondering how you're thinking about that as it is.

Dan Dischner: And then on business development, I'm wondering how you're thinking about that as something that might kickstart your goal of getting to pipeline 50% proprietary programs by next year versus using BD more as a tool to maybe add a complementary market-ready asset like a back semi.

Jimmy: That might kickstart your goal of getting to.

Speaker Change: Pipeline, 50% proprietary programs by next year.

Speaker Change: Versus using BD more as a tool to maybe add a complementary market ready asset like Jimmy thanks.

Dan Dishner: Thanks. Yes, so first one on the vaccine, the market trend, the third quarter is always the biggest quarter, so we're expecting it to certainly ramp up from the second quarter on that basis. So when we move from having them sell a majority of vaccines to having us sell a majority of vaccine, that we start incurring a significantly more cost of goods for those revenues; therefore, the gross margin trend does drop. And so one of the things that I want to make sure people realize is that that trend will continue on into the next quarter as we start picking up more countries in the quarter.

Bill Peters: We would like to note that we just completed the first contract year of the five contract year period for potential milestone payments to Lillian. The four potential milestone payments are based on annual and cumulative five year sales of vaccineing, cumulative vaccine sales in the first quarter or the first year totaled $163.2 million so none of these milestone payments for traders. Our informed API business had sales of $3.5 million, up from $2.8 million last year, as we have shipped RHI API to mankind for the last time until they have qualified our updated material.

Dan Dischner: Yeah, so first one on the vaccine and the market trend: the third quarter is always the biggest quarter. So we're expecting it to certainly ramp up from the second quarter on that basis. And the other thing is that in accounting, remember that when Eli Lilly books the sale, when they're the distributor, and we get the net economic benefit, that's at 100% gross margin. There's no cost of goods associated with that, so we're getting that at a net profit.

unknown: Yeah, so first one on the vaccine and the market trend: the third quarter is always the biggest quarter. So we're expecting it to certainly ramp up from the second quarter on that basis. And the other thing is that in accounting, remember that when Eli Lilly books the sale, when they're the distributor, and we get the net economic benefit, that's at 100% gross margin, there's no cost of goods associated with that. So we're getting that net.

Dan Dischner: Thanks. Yes, the first one on the back.

Speaker Change: Yeah. So the first one on the vaccine.

Speaker Change: The market trends there, yes third quarter is always the biggest quarter. So we're expecting it to certainly ramp up from the second quarter on a on the on that basis and the other thing is that on the accounting remember that when Eli Lilly books are the sad when theres, a distributor and we get the net economic benefit that.

Speaker Change: At 100% gross margin, there's no cost of goods associated with that so we're getting out in that so when we moved from having them sell a majority of vaccine needs to having us sell a majority of vaccine me.

unknown: So when we move from having them sell a majority of vaccines to having us sell a majority of vaccines, we start incurring significantly more cost of goods for those revenues. Therefore, the gross margin trend does drop. And so one of the things I want to make sure people realize is that that trend will continue into the next quarter as we start picking up more countries in the quarter. As far as business development goes, yeah, so we're actively looking for things. And we've actually looked at things that are both in development and more like vaccines already on the market.

Dan Dischner: So when we move from having them sell a majority of vaccines to having us sell a majority of vaccines, we start incurring a significantly higher cost of goods for those revenues. Therefore, the gross margin trend does drop. And so one of the things I want to make sure people realize is that that trend will continue on into the next quarter as we start picking up more countries in the quarter. As far as business development goes, yeah, so we're actively looking for things, and we've actually looked at things that are both in development and more like vaccines already on the market.

Speaker Change: The debt that we start incurring a significantly more cost of goods for those revenues. Therefore, the gross margin trend does is dropping so I'm one of the things that I want to make sure people realize is that that trend will continue on into the next quarter as we start picking up more countries Oh.

Bill Peters: Cost of revenues increased to $87.2 million from $73 million and gross margins improved to 52.2% from 49.9% in the previous year. The benefit of increased sales of higher margin products such as Baxime, Primativeness and Epinephrine were partially offset by increased depreciation and memorization related to Baxime and increases in labor and certain component costs. Selling distribution and marketing expenses increased 34% to $9 million from $6.7 million in the previous year's period due to sales force expansion and marketing expenses related to Baxime.

Speaker Change: In the quarter as far as the business development goes yeah. So we're actively looking for things and we are we've actually looked at things that are both in development and more like vaccine you already on the market. So we've actually been in.

Dan Dishner: As far as the business development goes, yeah, so we're actively looking for things, and we've actually looked at things that are both in development and more like vaccine we already on the market. So we've actually been in discussions with those things that there's nothing to announce at this time, and I don't want to say we're close on anything, but we remain diligent and also want to make sure that we're paying the right price for these assets. So a couple of processes that we've looked at this year have been competitive processes where we're not necessarily the highest bidders, but we're okay with that because we want to remain disciplined.

Dan Dischner: So we've actually been in discussions about both of those things. There's nothing to announce at this time, and I don't want to say we're close to anything, but we remain diligent and also want to make sure that we're paying the right price for these assets. So a couple of the processes that we've looked at this year have been competitive processes where we're not necessarily the highest bidder, but we're okay with that because we want to remain disciplined.

Speaker Change: Discussions with both of those things that you know there's nothing to announce at this time and I don't want to say, we're close on anything but.

unknown: So we've actually been in discussions about both of those things. But there's nothing to announce at this time. And I don't want to say we're close to anything, but we remain diligent and also want to make sure that we're paying the right price for these assets. So a couple of the processes that we've looked at this year have been competitive processes where we're not necessarily the highest bidder, but we're okay with that because we want to remain disciplined. We have strong faith in our R&D pipeline.

Speaker Change: We remain.

Speaker Change: Elegance and also want to make sure that we're paying the right price for these assets. So a couple of the processes that we've looked at this year have been competitive processes, where I'm more not necessarily the highest bidder. So but we're okay with that because we want to remain disciplined and we have a strong faith in our R&D pipeline. So we really want to make.

Bill Peters: General and administrative spending increased 8% to $13.3 million from $12.3 million, primarily due to increased expenses related to Baxime. Research and development expenditures increased 5% to $17.7 million from $16.8 million due to an increase in salary and personal related expenses as well as the ANDA filing fee for AMP 018. These increases were partially offset by decreasing and decreases in clinical trial expenses due to the timing of clinical trials. Non-operating expenses increased to $5 million from $4.1 million, primarily driven by increased interest expense on loans associated with the acquisition of Baxime.

Dan Dishner: We have a strong faith in our R&D pipeline, so we really want to make sure that that's our first number one focus. And if we do any business development on top of that, that's really just a nice thing on the cake.

Dan Dischner: We have a strong faith in our R&D pipeline, so we really want to make sure that that's our number one focus. And if we do any business development on top of that, that's really just icing on the cake.

unknown: So we really want to make sure that that's our number one focus. And if we do any business development on top of that, that's really just the icing on the cake.

Speaker Change: Sure that that's our first number one focus and if we do any business development on top of that just that's really just icing on the cake.

Dan Dishner: Okay, thanks, guys. Thanks.

Operator: Okay. Thanks, guys. Thanks. Thank you. Our next question is from Tim Chiang with Capital One. Please proceed with your question. I think. So, just a couple. Could you just comment on how you think RecStovi will do for you guys when you launch that in the second quarter?

Speaker Change: Got it okay. Thanks, guys.

Speaker Change: Thanks.

Dan Dishner: Thank you.

unknown: And then secondly, just sort of comment on, you know, how you expect selling and marketing costs to shape up in the back half of the year versus the first half as you, you know, fully take over back semi-? in the U.S., some of these other countries, well, not just in the U.S. Yeah, thanks, Tim. You know, Rex Tovey, as you know, is a crowded field.

Timothy Chiang: Thank you. Our next question is from Tim Chiang with Capital One. Please proceed with your question. I think

Speaker Change: Thank you. Our next question is from Tim Chiang with capital. One. Please proceed with your question.

Tim Chang: Our next question is from Tim Chang with Capital One. Please proceed with your question. I think that's just a couple. Could you just comment on how you think Rex Dovey will do for you guys under you launched that in the second quarter.

Dan Dischner: Could you just comment on how you think RecStovi will do for you guys? I know you launched that in the second quarter. And then secondly, just sort of comment on, you know, how you expect selling and marketing costs to shape up in the back half of the year versus the first half as you, you know, fully take over back semi-auto in the U.S. and some of these other countries, well, not just in the U.S.

Timothy Chiang: I think so. Just a couple.

Tim Chiang: Alright, Thanks, So just a couple.

Tim Chiang: Could you just comment on how you think ricks Toby will do for you guys. I know you launched that in the second quarter.

Bill Peters: Net income increased 45% to $37.9 million or $73 cents per share in the second quarter from $26.1 million or $49 cents per share in the second quarter of 2023. Adjusted net income increased to $48.7 million or 94 cents per share compared to an adjusted net income of $34.8 million or $65 cents per share in the second quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of loan with assets in one time events.

Tim Chang: And then secondly, just sort of comment on how you expect selling and marketing costs to shape up in the back half of the year versus the first half as you fully take over back to me in the US and some of these other countries. Well, not just in the US. Yeah, thanks, Tim. Rex Dovey, as you know, is a crowded field. And one thing our focus is on more of the government, first responders, or municipalities and first responders. And as we've discussed before, our product is also different. We're using our proprietary device. So it's still too early to really say how we're going to do there.

Speaker Change: And then secondly, just sort of comment on.

Speaker Change: How you expect selling and marketing costs.

Speaker Change: To shape up in the back half of the year versus the first half.

Speaker Change: As you know.

Speaker Change: Fully takeover back shimmy.

Speaker Change: In the U S.

Speaker Change: Some of these other country well, it's not just in the U S.

Dan Dischner: Yeah, thanks, Tim. You know, Rextovi, as you know, is a crowded field.

unknown: And one thing, you know, our focus is on more government first responders, municipalities, and first responders. And, and, as we've discussed before, our product is also different. We use our proprietary device. So it's still too early to really say how we're going to do there; it takes time to secure those contracts, but we don't really anticipate it being a big product for us, just because of the competitive nature of that, that environment there. And then on the sales and marketing trend, two things there. One is that for most foreign entities, we don't really have a significant sales and marketing trend.

Tim Chiang: Yeah. Thanks, Tim you know Rex Dolby as you know is a it's a crowded field and one thing you know our focus is on more of the government first responders are municipalities and first responders.

Dan Dischner: And one thing, you know, our focus is on more government first responders, municipalities, and first responders. And, and, as we've discussed before, our product is also different. Our, you know, we're using our proprietary device.

Bill Peters: In the second quarter, we had cash flow from operations of approximately $69.1 million. During the quarter, we made the required $129 million payment to the lease for the Baxime acquisition. In addition, we used the portion of our cash to buy back $8.5 million worth of shares and to pay down the mortgage for $8 million.

Speaker Change: And as we've discussed before our product is also.

Speaker Change: It's different are you know, we're using our proprietary device. So it's it's still too early to really say, how we're going to do there. It takes time to secure those contracts, but we don't really anticipate it being a big product for us just because of the competitive nature of that that environment there.

Dan Dischner: Proprietary device. So it's still too early to really say how we're going to do there. It takes time to secure those contracts, but we don't really anticipate it being a big product for us just because of the competitive nature of that environment there. And then on the sales and marketing trend, two things. One is that for most of the foreign entities, we don't really have a significant sales and marketing presence.

Tim Chang: It takes time to secure those contracts.

Dan Dishner: But we don't really anticipate it being a big product for us just because of the competitive nature of that environment there.

Dan Dishner: I will now turn the call back over to Dan. Thank you, Bill, for the update.

Dan Dishner: With that, we will now take your questions.

Operator: Operator, please open the line for Q&A. Thank you.

Dan Dishner: And then on the sales and marketing trends, two things there. One is that for most of the foreign entities, we don't really have a significant sales and marketing trend. It's mostly a distribution agreement. So we will have distribution expense. It's going to fall into the cost of... because of good category there. However, as we look at the United States and we ramp up, we are planning to add some people to the sales force, so the sales force is slated to grow in the third quarter. And you know, obviously, that's an incremental growth as we make sure that we cover some more territories that were not as well covered in the past.

Speaker Change: And then on the sales and marketing trend too.

Operator: We'll now be conducting any question and answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation telephone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your hand step before pressing the star keys. One moment, please, while we pull for questions.

Speaker Change: Two things there one is that for most of the foreign entities. We don't really have a significant sales and marketing trend. That's mostly a distribution agreement. So we will have distribution expense, it's going to fall into the cost of our cost of goods category. There. However, as we look at the United States and we ramp up we are planning to add some people to the sales force or the sales.

Operator: Thank you.

Dan Dischner: It's mostly a distribution agreement, so we will have distribution expense that's going to fall into the cost of goods category there. However, as we look at the United States and ramp up, we are planning to add some people to the sales force, so the sales force is slated to grow in the third quarter. And I'll say that it's an incremental growth as we make sure that we cover some more territories that were not as well covered in the past.

unknown: It's mostly a distribution agreement, so we will have distribution expenses that are going to fall into the cost of goods category there. However, as we look at the United States and ramp up, we are planning to add some people to the sales force. So the sales force is slated to grow in the third quarter, and I'll say that it's an incremental growth as we make sure that we cover some more territories that were not as well covered in the past.

Tim Chiang: Forces is slated to grow in the third quarter and you'll see that as an incremental growth as we make sure that we cover some more territories that we're not not as well covered in the past. So we are growing that and one way to think about it is that we're probably going to spend a similar percentage of sales.

Ike Dorena: Our first question is from Ike Dorena, Nia Kova, with J.P. Morgan. Please proceed with your question. Hi. Thank you so much. Just two from me if I may. So first, just an epinephrine seems like another very strong quarter for the product.

Dan Dischner: So we are growing that, and one way to think about it is that we're probably going to spend a similar percentage of sales as we did for Vaximi a year ago. So the sales are up about 10%, and so the sales and marketing expense should grow about 10% as well. Okay, got it.

Dan Dishner: So we are growing that, and the one way to think about it is that we're probably going to spend a similar percentage of sales as we did for Vaccine Me a year ago. So the sales are up about 10 percent, so that sales and marketing essentially grow about 10 percent as well. Okay, got it.

unknown: So we are growing that, and one way to think about it is that we're probably going to spend a similar percentage of sales as we did for Vaximi a year ago. So sales are up about 10%, and so the sales and marketing expense should grow about 10% as well. Okay.

Dan Dischner: Okay, I got it. Thanks.

Tim Chiang: We did for.

Tim Chiang: For vaccine me a year ago. So the sales are up.

Bill Peters: Can you just maybe talk about acceptations for that franchise over time, both from a competitor or supply shortage standpoint, if you're seeing any changes there, as well as potentially other players either entering or filing an application in that market? And then just second question is generic pro-air. Can you just help us frame how you're thinking about the size of that opportunity, and how quickly you can launch an SMZ decided to do so, and how quickly you can, I guess, get uptake for that product.

Speaker Change: About 10% and so the sales and marketing expense to grow about 10% as well.

Speaker Change: Okay got it thanks.

Tim Chiang: Thanks, Tim.

Operator: Thanks. Thank you. Our next question is from Serge Belanger with Needham & Company. Please proceed with your question. Hey, good afternoon. A couple questions. First on Baccimi.

Serge Belanger: Thank you. Our next question is from Serge Belanger with Needham & Company. Please proceed with your question.

Speaker Change: Thank you. Our next question is from Serge Belanger with Needham <unk> Company. Please proceed with your question.

unknown: I think you mentioned sales were up about 10% year over year this quarter. I'm just curious if that was volume and market share driven, or if there was a price increase involved in that growth. And then secondly, on the pipeline, you highlighted three annual approvals that you're expecting over the second half. Maybe talk about the market opportunity for each and how they compare to the generic prior opportunity in terms of being impactful on Amphastar's top line. Sure, so I'll take the first thing.

Dan Dischner: Good afternoon. I have a couple of questions. First on Baksimi, I think you mentioned sales were up about 10% year over year this quarter. I'm just curious if that was volume and market share driven, or if there was a price increase involved in that growth. And then secondly, on the pipeline, you highlighted... and the three annual approvals that you're expecting over the second half. Maybe talk about the market opportunity for each and how they compare to the generic prior opportunities. In terms of being impactful to the, Amphastar's top line, I'll take the first thing.

Serge Belanger: Hey, good afternoon.

Speaker Change: Couple of questions first on.

Speaker Change: Excuse me I think you mentioned.

Bill Peters: Thank you so much. So for the epi, we do have, you know, we have two different presentations for that product. First of all, those multi-dose file and a pre-filled syringe. And the pre-filled syringe has been on the drug shortage supply list for almost a year now, or about a year now, based on a hurricane that has hit one of our competitors. So that portion of the business has remained relatively robust. However, as Dan had mentioned in his comments, what we've done is we've taken some steps to increase the capacity of that plant by increasing some of the efficiency of some of the labor and the different packaging steps.

Speaker Change: We're up about 10% year over year this quarter.

Serge Belanger: I'm just curious if that was volume and market share driven or are there was a price increase involved in that growth.

Serge Belanger: And then, secondly, on the pipeline, you highlighted three annual approvals that you're expecting over the second half. Maybe talk about the market opportunity for each and how they compare it to the generic prior opportunity in terms of being impactful to Amphistar's top line. Thanks.

Tim Chiang: And then secondly on the pipeline.

Speaker Change: You highlighted.

Speaker Change: Three anda approvals that you're expecting over the second half maybe.

Speaker Change: Maybe just talk about the market opportunity for each and.

Speaker Change: How do they compare to the.

Speaker Change: Generic career opportunity.

Speaker Change: In terms of being impactful to <unk>.

Speaker Change: <unk> top line.

Dan Dishner: Sure, so I'll take the first thing. Units were up; remember the main thing in the United States is not that we're something there, that we actually have a net pricing decrease in the United States because we have higher fees that we have to pay to the wholesalers. So that's a growth in that item, so we actually see a price reduction in the United States this year for the second quarter. So all of that, and more, is unicrowth. And the pricing outside of the U.S. really hasn't changed much at all other than, you know, there's only one country that had a material change.

Dan Dischner: Units were up. Remember, the main thing in the United States is that now that we're somewhat there, we actually have a net pricing decrease in the United States because we have higher fees that we have to pay to the wholesalers. So that's a gross to net item. So we actually saw a price reduction in the United States this year for the second quarter. So all of that and more is unit growth.

Dan Dischner: Sure. So I'll take the first thing.

Speaker Change: Sure So I'll take the first thing.

unknown: Units were up; remember, the main thing in the United States now that we're so much there is that we actually have a net pricing decrease in the United States because we have higher fees that we have to pay to the wholesalers. So that's a gross to net item. So we actually saw a price reduction in the United States this year for the second quarter. So all of that and more is unit growth, and the pricing outside of the U.S. really hasn't changed much at all, other than maybe there's only one country that had a material change, that moved from me.

Speaker Change: Units were up remember the the main thing in the United States is not that we're selling out there is that we actually had a net pricing decrease in the United States because we have higher.

Bill Peters: So we've been able to increase the production of that product and pump out more sales as we as we showed this quarter. So we do expect that shortage for that product will be, you know, we're seeing from the competitor that they're gonna start returning to the market in the fourth quarter now. I think last quarter, they said the third quarter, this quarter is saying the fourth quarter, so but returning to a regular supply sometime next year.

Speaker Change: The fees that we have to pay to the wholesalers. So that's a gross to net items. So we actually see a price reduction in the United States. This year for the second quarter.

Speaker Change: So all of that and more as unit growth and that the pricing outside of the U S really hasn't changed much at all.

Dan Dischner: And the pricing outside of the US really hasn't changed much at all, other than maybe there's only one country that had a material change, and that's because it moved from a government pay to a non-government pay over some price negotiations. So the price went up, but the units went down.

Bill Peters: So, you know, it's hard to say exactly, but, you know, right now we're just preparing ourselves to make sure that we can take advantage of this and we can supply as much as needed to the industry.

Speaker Change: Other than you know.

Speaker Change: Maybe there's only one country that had a material change in that because it moved from a government.

Dan Dishner: And that's because it moved from a government pay to a non-government pay, or some price negotiations, so a price went up to the units went down. And as far as the ANDA is for the market share, you know, so teriparatide, you know, as you know, there's already a multiplayer market. So I think our expectations are that we'll get a reasonable market share of that product, but it's not going to be as big as we had thought at one point. AMP002, I think what we've said in the past is that it's a relatively large market, but we're going to be somewhat capacity constrained for that market.

unknown: A government pays to a non-government pays over some price negotiations, so the price went up at the end. Um, and as far as the ANDAs for the market share, Terraparatide, as you know, it's already a multiplayer market.

Speaker Change: Government paid a nongovernment payer, where some price negotiation. So the price went up but the units went down.

Bill Peters: As far as the multi-dose file, there is a new competitor to that one out there, so we do expect that the sales of that presentation will drop somewhat as the market has gone from two to three suppliers. Yeah, on the generic pro-air, as we mentioned in the call, we have launched the product, so we've already got it out there. Where we're going with that, you know, obviously there are other competitors in the market and we're still working on securing business there.

Speaker Change:

Dan Dischner: And as far as the ANDAs for market share, you know, so Teraparatide, you know, as you know, it's already a crowded market, so I think, you know, our expectations are that we'll get a reasonable market share of that product, but it won't be as big as we had thought at one point. AMP002, I think what we've said in the past is that it's a relatively large market, but we're going to be somewhat capacity constrained for that market, so we're probably going to get a lower market share than what you'd consider to normally have in a two-player market, but we still see it as being a good market and a large market for us.

Speaker Change: And as far as the Andas for the market share.

Speaker Change: So tariff parity side, you know as as you know there's already a multi player market. So I think the you know our expectations are that we will get to a.

unknown: So I think our expectations are that we'll get a reasonable market share of that product, but it's not gonna be as big as we had thought at one point. AMP002, I think what we've said in the past is that it's a relatively large market, but we're gonna be somewhat capacity constrained for that market. So we're probably going to get a lower market share than what you'd consider to normally have in a two-player market, but we still see it as being a good market and a large market for us.

Speaker Change: A reasonable market share of that product, but it's not going to be as big as we had thought at one point A&P zero zero to I think what we've said in the past is that it's a relatively large market, but we're gonna be somewhat capacity constrained for that market. So we're going to probably get a lower market share than what you would consider the norm.

Bill Peters: So, right now I don't know that we're really have a good idea, but it's been received well so far, so hopefully we'll be able to give an update a better update later. And one of the things with that one is that we're increasing the capacity of the packaging over time, so we might be off to, I don't want to say a more moderate start, but then we expect to increase that ability to meet the demand for that product over the course of the next few quarters, right? Thank you, I appreciate it. Thank you.

Dan Dishner: So we're going to probably get a lower market share than what you'd consider the normally have in a two-player market, but we still see it as being a good market and a large market for us.

Speaker Change: We have an a and a two player market, but we still see it as being a good market and a large market.

Dan Dishner: And then AMP007, we haven't said because we've been somewhat... Yeah, yeah. Consciously about the issue there because we don't want to let people know what the product is for competitive reasons, so I will say that we see this as a very good market opportunity for us, though. Thanks, Serge.

Speaker Change: For Us and then A&P a 007, we haven't said because we don't we.

unknown: And then AMP007, we haven't said that because we've been somewhat deliberately clouding the issue there because we don't want to let people know what the product is for competitive reasons. So I will say that we see this as a very good market opportunity for us, though. Thank you. Our next question is from Glen Santangelo with Jeffries. Please proceed with your question.

Dan Dischner: and then AMP007. We haven't said anything because we don't want to, we've been somewhat, you know..., intentionally clouding the issue there because we don't want to let people know what the product is for competitive reasons. But I will say that we see this as a very good market opportunity for us.

Dan Dischner: Thank you. Our next question is from Glen Santangelo with Jeffries. Please proceed with your question.

Speaker Change: Then somewhat.

Speaker Change: Yeah.

Speaker Change: Consciously clouding the issue there because we don't want to let people know what the product is for competitive reasons. So I will say that we see this as a very good market opportunity for us though.

David Amsalem: Our next question is from David Amsalon with Piper Sandler. Please proceed with your question. Thanks.

Serge Belanger: Thanks Serge.

Glen Santangelo: Thank you. Our next question is from Glen Santangelo with Jeffries. Please proceed with your question. Thanks for taking my question. Hey, Bill, I also wanted to unpack back to see me a little bit because what's interesting is the results were probably better than I think we were expecting. You know, looking at some of the script data, it looked like the numbers were trending in negative territory for the first quarter. Based on your response to the previous question, you kind of made it sound like it was more volume driven than price driven.

Speaker Change: Thank you. Our next question is from Glenn Santana Jeweler with Jefferies. Please proceed with your question.

Bill Peters: Got a couple of pipeline questions. I know 002 has been beaten over the head, but is there anything new that you could add regarding your interactions with the FDA, or more specifically what they're hung up on? That's number one, number two on the GLP-1. Just to remind us, is that P4 or a P3 is that a litigated filing, and is there already generic competition, or do you anticipate that there will be others when you're in a position to launch? So that's number two.

Glen Santangelo: Right, yeah, thanks for taking my question. Hey, Bill, I also wanted to unpack Vaccinia a little bit because what's interesting is the results were probably better than I think we were expecting. You know, looking at some of the script data, it looked like the numbers were trending in negative territory for the first quarter. Based on your response to the previous question, you kind of made it sound like it was more volume-driven than price-driven.

Operator: Yeah, thanks for taking my question. Hey, Bill, I also wanted to unpack Vaximi a little bit because, what's interesting is that the results were probably better than I think we were expecting. You know, looking at some of the script data, it looked like the numbers were trending in negative territory for the first quarter. Based on your response to the previous question, you kind of made it sound like it was more volume-driven than price-driven.

Speaker Change: Oh, yeah. Thanks for taking my question, Hey, Bill I also wanted to unpack that see me a little bit because what's interesting is the results were probably better than I think we were expecting you know looking at some of the scripted it looked like the numbers were trending in negative territory for the first quarter based on your response to the previous question you kind of made at Sally.

unknown: So, you know, could you maybe reconcile those data points and what drove the strength in the quarter? And then maybe related to that, as we look for the back half of the year, could you maybe give us a little more color on the country-by-country transition and when you think the transition to Amphastar will be fully complete? So yeah, so the units in the quarter, yeah, I will say that we had a couple hiccups as we transitioned from Lilly supply numbers to ours and DC numbers in certain drugstore chains and certain government programs, so we did have a hiccup and there was a little bit of a time during the second quarter where we weren't getting every script we should have been getting, but I think all of those problems were resolved by the end of the quarter, and so I think we're expecting the third quarter to tick back up the way it should be.

Speaker Change: It was more volume driven than price driven so could you maybe reconcile those data points and what drove the strength in the quarter and then and then maybe related to that as we look at it.

Glen Santangelo: So, you know, could you maybe reconcile those data points and what drove the strength in the quarter? And then maybe related to that, as we look at the back half of the year, could you maybe give us a little more color on the country-by-country transition and when you think the transition to Amphastar will be fully complete?

Dan Dishner: So, you know, could you maybe reconcile those data points and what drove the strength in the quarter and then maybe relate it to that as we look for the back after the year, could you maybe give us a little more color on the country by country transition and when you think the transition to Amphastar will be fully complete? Sure. So, yeah, so the units in the quarter, yeah, I will say that we had a couple hiccups as we transitioned from Lilly supply numbers to ours and DC numbers in certain drug search chains and certain government programs. So, we did have a hiccup, and there was a little bit of a time during the second quarter where we weren't getting every script we should have been getting. But I think all of those problems were resolved by the end of the quarter, and so I think we're expecting the third quarter to tick back up the way it should be.

Speaker Change: The back half of the year could you maybe give us a little more color on the country by country transition and when do you think the transition to amp to start will be fully complete.

Bill Peters: And then number three on 017. Similar kind of question, is that a P4? Is that going to be a litigated filing, and talk about the nature of competition in that market? Thanks. Yeah, for MP002, we continue to have routine conversations with the agency. The last conversations we've had have been, and I guess maybe stepping back, the idea is just to kind of get a sense of what they're doing and the progress that they're making for the issue.

Dan Dischner: Sure, so yeah, so the units in the quarter, yeah, I will say that we had a couple hiccups as we transitioned from Lilly supply numbers to ours and DC numbers in certain drugstore chains and certain government programs. So we did have a hiccup, and there was a little bit of a time during the second quarter where we weren't getting every script we should have been getting, but I think all of those To a certain extent, some of the units sold later in the quarter were, I think, more of some wholesalers trying to gear up to make sure they had enough inventory in the channel because they want to make sure that they had enough for the large back-to-school surge that's usually happening in August. So I think that's part of it, and ex-US, we still had some nice trends there, so that's been going well as well.

Speaker Change: Sure. So yeah. So the units in the quarter, Yeah, We I will say that we had a couple hiccups as we transition from Lilly Hum supply numbers to ours and do you see numbers in certain drugstore chains in certain government programs. So we did have a hiccup and there was a little bit.

Speaker Change: A time during the second quarter, where we werent getting every script, we should've been getting but I think all of those problems.

Speaker Change: Problems were resolved by the end of the quarter and so I think we're expecting the third quarter to tick back up the way it should be to a certain extent some of the units sold later in the quarter were I think more of some of the wholesalers trying to gear up to make sure they had enough.

Bill Peters: We think we understand what their issue is, and based on those conversations, we feel that they're coming to an end to be able to resolve their issue. And so based on those calls that we routinely have with them, is why we feel that we believe it'll be a newer future that they'll take action on the application. For the AMP018, the GLP, it is a paragraph four filing on that product. And we're still within the period of time where we have not been sued to date, but we still could be, and that we do expect competition on this one when we're in a position to launch the product. And AMP007, that is a paragraph four filing as well. And you expect competition? It's hard to say at this point. We rather not say at this point. All right, fair enough, thanks. Thanks.

unknown: To a certain extent, some of the units sold later in the quarter were, I think, more of some wholesalers trying to gear up to make sure they had enough inventory in the channel because they want to make sure that they had enough for the large back-to-school surge that's usually happening in August. So I think that's part of it, and ex-U.S., we still had some nice trends there, so that's been going well as well.

Dan Dishner: To a certain extent, some of the units sold later in the quarter were, I think, more of some of the wholesalers trying to gear up to make sure they had enough inventory in the channel because they want to make sure that they had enough for the large back-to-school search that's usually happening in August. So, I think that's part of it, and XXUS, we still had some nice trends there, so that's been going well as well. As far as the country by country basis, our goal is to get a majority of other countries that are not distributed by Amphastar over to our distribution by the end of this quarter.

Speaker Change: Inventory in the channel because they wanted to make sure that they had enough for the the large back to school surge, it's usually happening in in August. So I think that's part of it and an X X U S and we still had some some nice trends there. So that's it.

Operator: Thank you.

Speaker Change: That's been going well as well.

unknown: As far as country-by-country basis, our goal is to get a majority of other countries that are not distributed by Amphastar over to our distribution by the end of this quarter. So we have a lot of countries planned for cutover in August and September. So this is going to be another one of those quarters that's a little bit mixed in that there are going to be multiple countries that are cutting over throughout this.

Dan Dischner: As far as country-by-country basis, our goal is to get a majority of other countries that are not distributed by Amphastar over to our distribution by the end of this quarter. So we have a lot of countries planned for cutover in August and September. So this is going to be another one of those quarters that's a little bit mixed in that there are going to be multiple countries that are cutting over throughout this.

Speaker Change: As far as the country by country basis.

Speaker Change:

Speaker Change: Our goal is to get a majority of other countries that are not not distributed by amstar over to our distributions by the end of this quarter. So we have a lot of countries planned for cutover in August and September. So this is gonna be another one of those.

Dan Dishner: So, we have a lot of countries planned for cut over in August and September. So, this is going to be another one of those quarters that's a little bit mixed and that there's going to be multiple countries that are cutting over throughout this. So, our expectation is that by the fourth quarter there will only be three countries that are still being distributed by Lily. Our goal is probably on the spinal three. We might not take over distribution of them until January 1st. So, we're still looking at either a December transition for those spinal three countries or maybe January 1st.

Speaker Change: <unk>, that's a little bit mixed and that there's going to be multiple countries that are cutting over.

Speaker Change: Hum throughout this so our expectation is that by the fourth quarter. There will only be three countries that are still being distributed.

unknown: So our expectation is that by the fourth quarter, there will only be three countries that are still being distributed by Lilly. Our goal is probably those final three. We might not take over distribution of them until January 1st, so we're still looking at either a December transition for those final three countries or maybe January 1st. But most countries should be our distribution by the end of the third quarter, which means that the fourth quarter will be a little cleaner from that standpoint; it'll be a little truer.

Dan Dischner: So our expectation is that by the fourth quarter, there will only be three countries that are still being distributed by Lilly. Our goal is probably for those final three; they might not, we might not take over distribution of them until January 1st. So we're still looking at either a December transition for those final three countries or maybe January 1st. But most countries should be in our distribution by the end of the third quarter, which means that the fourth quarter will be a little cleaner from that standpoint. It'll be a little truer.

Lilly: By by Lilly.

Lilly: Our goal is probably on the spinal III they might not we might not take over distribution of them until January 1st. So we're still looking at either a December transition for those final three countries or.

Lilly: Maybe maybe January 1st so, but most countries should be our distribution by the end.

Dan Dishner: But most countries should be our distribution by the end of the third quarter, which means that the fourth quarter will be a little cleaner from that standpoint.

Speaker Change: Third quarter, which means that the fourth quarter will be a little cleaner from that standpoint, and it'll be a little chair.

Glen Santangelo: Perfect. I appreciate all those details.

Glen Santangelo: Perfect. I appreciate all those details. Maybe I can just ask one quick follow-up. You know, on some of the other product categories, like when we think about lidocaine and phytonadine, you know, we see supply issues, you know, ebbing and flowing in the market, and that creates sort of these big swings in the results. And so, as you look to the back half, without maybe giving specific guidance, are there any sort of, you know, product areas you'd call out where you're seeing either shortages or competitors sort of coming back online that influence, you know, some of those product categories in the back half? And I'll stop there. Thanks. Yeah, so as

unknown: Perfect. I appreciate all those details. Maybe I can just ask one quick follow-up. You know, on some of the other product categories, like when we think about, like, lidocaine and phytonadine, we see, you know, supply issues ebbing and flowing in the market, and that creates sort of these big swings in the results. And so, as you look to the back half, without maybe giving specific guidance, are there any sort of, you know, product areas you'd call out where you're seeing either shortages or competitors sort of coming back online that influence, you know, some of those product categories in the back half? And I'll stop there.

Speaker Change: Perfect I appreciate those details maybe I can just ask one quick follow up on some of the other product categories like when we think about like lidocaine and <unk>, we see the supply issues.

Dan Dishner: Maybe I just asked one quick follow-up. You know, on some of the other product categories, like when we think about like lighted cane and phytonidine, you know, we see, you know, the supply issues, you know, ebbing and flowing in the market, and that creates sort of these big swings and the results. And so, as you look to the back half, but without maybe getting specific guidance, are there any sort of, you know, product areas you'd call out where you're seeing either shortages or competitors sort of coming back online to influence, you know, some of those product categories in the back half.

Jason Gerber: And then on business development, wondering how you're thinking about that as something that might kick start your goal of getting to pipeline 50% proprietary programs by next year versus using BD more as a tool to maybe add a complementary market-ready asset like Beck-Simmy. Thanks.

Speaker Change: Having and flowing in the market and that creates sort of these big swings in the results and so it looks it looks in the back half so without maybe giving specific guidance are there any sort of.

Speaker Change: All product areas, you'd call out, where you're seeing either shortages or or competitors shorted coming back online.

Bill Peters: Yes, so first one on the vaccine, the market trend, the third quarter is always the biggest quarter, so we're expecting it to certainly ramp up from the second quarter on that basis. So when we move from having them sell a majority of vaccines to having us sell a majority of vaccine that we start incurring a significantly more cost of goods for those revenues, therefore the gross margin trend does drop. And so one of the things that I want to make sure people realize is that that trend will continue on into the next quarter as we start picking up more countries in the quarter.

Speaker Change: Fluence, you know some of those some of those product categories in the back half.

Dan Dishner: And I'll stop there. Thanks. Yeah. So, as I mentioned, the competitor that had the supply problems over the last year has said that they will begin distribution of some of these supply-constrained products in the fourth quarter. So, we do expect that some of the, you know, they will be able to do that further for their disclosures. So, any of those things could drop off in the fourth quarter. We're not seeing that in the third quarter yet. So, the third quarter has got a whole thing steady, but, and as Dan had mentioned, I'll just point it out again.

Speaker Change: And I'll stop there thanks.

Dan Dischner: Yeah, so, um... As I mentioned, the competitor that had the supply problems over the last year has said that they will begin distribution of some of these supply-constrained products in the fourth quarter. So we do expect that some of the, you know, they will be able to do that for their disclosures. So any of those things could drop off in the fourth quarter. We're not seeing that in the third quarter yet.

unknown: Thanks. Yeah, so, um... As I mentioned, the competitor that had the supply problems over the last year has said that they will begin distribution of some of these supply-constrained products in the fourth quarter. So we do expect that they will be able to do that for their disclosures. So any of those things could drop off in the fourth quarter. We're not seeing that in the third quarter yet.

Speaker Change: Yeah. So.

Speaker Change: As I mentioned.

Speaker Change: The competitor that had the supply problems over the last year has said that they will begin distribution of some of these these supply constrained products in the fourth quarter. So we do expect that some of the you know they will be able to do that for their further disclosures. So any of those things could could drop.

Speaker Change: Off in the fourth quarter, we're not seeing that in the third quarter, yet so the third quarter is kind of holding steady but.

Dan Dischner: So the third quarter is kind of holding steady, but, and as Dan mentioned, I'll just point it out again, we have increased the capacity of the facility that makes all of those products so that we can take advantage of them. And that was one of the reasons that drove epinephrine sales in this quarter. We think it probably should drive higher sodium bicarbonate and dextrose sales in the third quarter. And with that, we can, you know, make more product out of that facility.

unknown: So the third quarter is kind of holding steady, and as Dan mentioned, I'll just point it out again, we have increased the capacity of the facility that makes all of those products so that we can better take advantage of them, and that was one of the reasons that drove the epinephrine sales in this quarter. We think it probably should drive higher sodium bicarbonate and dextrose sales in the third quarter. So with that, we can make more product out of that facility, hopefully taking advantage of these things as they come up. And so, you know, we want to be in a position so that if there is a supply shortage by another competitor of these products, we're able to supply the entire market.

Dan: And as Dan had mentioned I'll just point out again, we have increased the capacity of the facility that makes all of those products. So that we could take advantage of those and that was one of the reasons that through yet but that friends sales in this quarter, we think it probably shouldn't drive higher so that he can buy carbonate and dextrose sales in the third quarter.

Dan Dishner: We have increased the capacity of the facilities that makes all of those products so that we could take advantage of those. And that was one of the reasons that drove Yep, and that friend's sales in this quarter. We think it probably should drive higher setting by carbonate and dexterous sales in the third quarter. So, with that, we can, you know, make more product out of that facility. Hopefully, I'm seeing advantage of these things as they come up. And so, that, you know, we want to be in a position so that if there is a supply shortage by another competitor on these products, that we're able to supply the entire market.

Bill Peters: As far as the business development goes, yeah, so we're actively looking for things and we've actually looked at things that are both in development and more like vaccine we already on the market. So we've actually been in discussions with those things that there's nothing to announce at this time, and I don't want to say we're close on anything, but we remain diligent and also want to make sure that we're paying the right price for these assets.

Speaker Change: So with that we can.

Speaker Change: Make more product out of that out of that facility and hopefully I'm taking advantage of these things as they come up and so that you know, we we want to be in a position. So that if there is a supply shortage by another competitor on these products that we're able to supply the entire market. So we're kind of gearing up to be able to do that.

Dan Dischner: Hopefully, I'm taking advantage of these things as they come up. And so, you know, we wanna be in a position so that if there is a supply shortage by another competitor of these products, we're able to supply the entire market. So we're kind of gearing up to be able to do that.

Dan Dishner: So, we're kind of gearing up to be able to do that.

unknown: So we're kind of gearing up to be able to do that. Perfect. Thanks. Thanks. Go ahead.

Bill Peters: So a couple of processes that we've looked at this year have been competitive processes where we're not necessarily the highest bidders, but we're okay with that because we want to remain disciplined. We have a strong faith in our R&D pipeline, so we really want to make sure that that's our first number one focus. And if we do any business development on top of that, that's really just nice thing on the cake. Okay, thanks, guys. Thanks. Thank you.

Speaker Change: Yes.

Dan Dishner: Perfect. Thanks.

Speaker Change: Perfect. Thanks.

Operator: Thank you. There are no further questions at this point.

Speaker Change: Thank God.

Dan Dischner: Thank you. There are no further questions at this time. I'd like to hand the floor back over to management for any closing comments. I want to thank everyone for joining us today. The second half of 2024 remains to be a highly-anticipated period with three potential launches.

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

Speaker Change: Thank you there are no further questions at this time I would like to hand, the floor back over to management for any closing comments.

Dan Dishner: I'd like to hand the floor back over to management for any closing comments. I want to thank everyone for joining us today. The second half of 2024 remains to be a highly anticipated period with three potential launches.

Dan Dischner: I want to thank everyone for joining us today. The second half of 2024 remains to be a highly anticipated period with three potential launches. We look forward to updating you all again and again. Thank you.

Operator: We look forward to updating you all again. And again, thank you and have a great day. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

Speaker Change: I want to thank everyone for joining us today, the second half of 'twenty 'twenty four remains to be a highly anticipated period with three potential launches. We look forward to updating you all again and again, thank you and have a great day.

Dan Dishner: We look forward to updating you all again and again. Thank you, and have a great day.

Speaker Change: Yeah.

Operator: This concludes today's conference. You may disconnect your lives at this time. Thank you for your participation.

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

Tim Chang: Our next question is from Tim Chang with Capital One. Please proceed with your question. I think that's just a couple.

Speaker Change: This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.

Tim Chang: Could you just comment on how you think Rex Dovey will do for you guys under you launched that in the second quarter.

Speaker Change: Yeah.

Bill Peters: And then secondly, just sort of comment on how you expect selling and marketing costs to shape up in the back half of the year versus the first half as you fully take over back to me in the US and some of these other countries. Well, not just in the US. Yeah, thanks, Tim. Rex Dovey, as you know, is a crowded field. And one thing our focus is on more of the government, first responders or municipalities and first responders.

Bill Peters: And as we've discussed before, our product is also different. We're using our proprietary device. So it's still too early to really say how we're going to do there. It takes time to secure those contracts. But we don't really anticipate it being a big product for us just because of the competitive nature of that environment there.

Bill Peters: And then on the sales and marketing trends, two things there. One is that for most of the foreign entities, we don't really have a significant sales and marketing trend. It's mostly a distribution agreement. So we will have distribution expense. It's going to fall into the cost of.., because of good category there. However, as we look at the United States and we ramp up, we are planning to add some people to the sales force, so the sales force is slated to grow in the third quarter.

Bill Peters: And you know, obviously that's an incremental growth as we make sure that we cover some more territories that were not as well covered in the past. So we are growing that and the one way to think about it is that we're probably going to spend a similar percentage of sales as we did for vaccine me a year ago. So the sales are up about 10 percent, so that sales and marketing essentially grow about 10 percent as well. Okay, got it.

Operator: Thank you.

Serge Belanger: Our next question is from Serge Belanger with Needham and Company. Please proceed with your question. Thank you, afternoon. A couple of questions. First on Baximi. Like you mentioned, sales were up about 10 percent year over year of this quarter. I'm just curious if that was volume and market share driven or there was a price increase involved in that growth. And then secondly, on the pipeline, you highlighted three annual approvals that you're expecting over the second half. Maybe talk about the market opportunity for each and how they compare it to the generic prior opportunity in terms of being impactful to Amphistar's top line. Thanks.

Bill Peters: Sure, so I'll take the first thing. Units were up, remember the main thing in the United States is not that we're something there, that we actually have a net pricing decrease in the United States because we have higher fees that we have to pay to the wholesalers. So that's a growth in that item, so we actually see a price reduction in the United States this year for the second quarter. So all of that, and more, is unicrowth.

Bill Peters: And the pricing outside of the U.S, really hasn't changed much at all other than, you know, there's only one country that had a material change. And that's because it moved from a government pay to a non-government pay, or some price negotiations, so a price went up to the units went down. And as far as the ANDA is for the market share, you know, so terror paratide, you know, as you know, there's already a multiplayer market.

Bill Peters: So I think our expectations are that we'll get a reasonable market share of that product, but it's not going to be as big as we had thought at one point. AMP002, I think what we've said in the past is that it's a relatively large market, but we're going to be somewhat capacity constrained for that market. So we're going to probably get a lower market share than what you'd consider the normally have in a two-player market, but we still see it as being a good market and a large market for us.

Bill Peters: And then AMP007, we haven't said because we've been somewhat... Yeah, yeah. Consciously about the issue there because we don't want to let people know what the product is for competitive reasons, so I will say that we see this as a very good market opportunity for us though. Thanks, Serge.

Glen Santangelo: Thank you. Our next question is from Glen Santangelo with Jeffries. Please proceed with your question. Thanks for taking my question. Hey, Bill, I also wanted to unpack back to see me a little bit because what's interesting is the results were probably better than I think we were expecting, you know, looking at some of the script data, it looked like the numbers were trending in negative territory for the first quarter based on your response to the previous question, you kind of made it sound like it was more volume driven than price driven.

Glen Santangelo: So, you know, could you maybe reconcile those data points and what drove the strength in the quarter and then maybe relate it to that as we look for the back after the year, could you maybe give us a little more color on the country by country transition and when you think the transition to Amphastar will be fully complete? Sure. So, yeah, so the units in the quarter, yeah, I will say that we had a couple hiccups as we transitioned from Lilly supply numbers to ours and DC numbers in certain drug search chains and certain government programs.

Glen Santangelo: So, we did have a hiccup and there was a little bit of a time during the second quarter where we weren't getting every script we should have been getting but I think all of those problems were resolved by the end of the quarter and so I think we're expecting the third quarter to tick back up the way it should be. To a certain extent, some of the units sold later in the quarter were I think more of some of the wholesalers trying to gear up to make sure they had enough inventory in the channel because they want to make sure that they had enough for the large back to school search that's usually happening in August.

Glen Santangelo: So, I think that's part of it and XXUS, we still had some nice trends there so that's been going well as well. As far as the country by country basis, our goal is to get a majority of other countries that are not distributed by Amphastar over to our distribution by the end of this quarter. So, we have a lot of countries planned for cut over in August and September. So, this is going to be another one of those quarters that's a little bit mixed and that there's going to be multiple countries that are cutting over throughout this.

Glen Santangelo: So, our expectation is that by the fourth quarter there will only be three countries that are still being distributed by Lily. Our goal is probably on the spinal three. We might not take over distribution of them until January 1st. So, we're still looking at either a December transition for those spinal three countries or maybe January 1st. But most countries should be our distribution by the end of the third quarter which means that the fourth quarter will be a little cleaner from that standpoint.

Bill Peters: Perfect. I appreciate all those details. Maybe I just asked one quick follow-up. You know, on some of the other product categories, like when we think about like lighted cane and phytonidine, you know, we see, you know, the supply issues, you know, ebbing and flowing in the market, and that creates sort of these big swings and the results. And so, as you look to the back half, but without maybe getting specific guidance, are there any sort of, you know, product areas you'd call out where you're seeing either shortages or competitors sort of coming back online to influence, you know, some of those product categories in the back half.

Bill Peters: And I'll stop there. Thanks. Yeah. So, as I mentioned, the competitor that had the supply problems over the last year has said that they will begin distribution of some of these supply constrained products in the fourth quarter. So, we do expect that some of the, you know, they will be able to do that further for their disclosures. So, any of those things could drop off in the fourth quarter. We're not seeing that in the third quarter yet.

Bill Peters: So, the third quarter has got a whole thing steady, but, and as Dan had mentioned, I'll just point it out again. We have increased the capacity of the facilities that makes all of those products so that we could take advantage of those. And that was one of the reasons that drove yep, and that friend's sales in this quarter. We think it probably should drive higher setting by carbonate and dexterous sales in the third quarter.

Bill Peters: So, with that, we can, you know, make more product out of that facility. Hopefully, I'm seeing advantage of these things as they come up. And so, that, you know, we want to be in a position so that if there is a supply shortage by another competitor on these products that we're able to supply the entire market. So, we're kind of gearing up to be able to do that.

Bill Peters: Perfect. Thanks. Thank you.

Operator: There are no further questions at this point.

Dan Dishner: I'd like to hand the floor back over to management for any closing comments.

Dan Dishner: I want to thank everyone for joining us today. The second half of 2024 remains to be a highly anticipated period with three potential launches. We look forward to updating you all again and again.

Operator: Thank you and have a great day.

Operator: This concludes today's conference. You may disconnect your lives at this time. Thank you for your participation.

Q2 2024 Amphastar Pharmaceuticals Inc Earnings Call

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