AMPHASTAR JPM 2025_.pdf

1、J.P.Morgan Healthcare ConferenceJanuary 2025Highly Purified Peptide/ProteinProprietaryInjectables Inhalation IntranasalBiosimilar InterchangeableComplex Generic Combination Products2Forward Looking StatementsThis presentation and the accompanying oral presentation contain forward-looking statements,

2、of Amphastar Pharmaceuticals,Inc.(“Amphastar”,“we”.“our”and that are based on our managements current expectations and assumptions and on information currently available to management.Forward-looking statements include all statements other than statements of historical fact contained in this present

3、ation,including,but not limited to,information concerning our business plans and objectives,potential growth opportunities,product development,regulatory approvals,market potential,efficiencies,competitive position,and industry environment,among other statements.All statements in this presentation r

4、eferenced above that are not historical are forward-looking statements,including,among other things,statements relating to our expectations regarding future financial performance and business trends,our future growth,sales and marketing of our products,market size and expansion,product portfolio,pro

5、duct development,the timing of FDA filings or approvals,including the DMFs of ANP,the timing of product launches,acquisitions and other matters related to our pipeline of product candidates,the timing and results of clinical trials,the benefits of the acquisition of BAQSIMI,including its potential f

6、or continued revenue growth,the success of our integration of BAQSIMI,the transition of our pipeline towards branded products,proprietary products,and biosimilars,our ability to leverage our existing expertise and technology,and other future events.These statements are not facts but rather are based

7、 on Amphastars historical performance and our current expectations,estimates,and projections regarding our business,operations,and other similar or related factors.Words such as“may,”“might,”“will,”“could,”“would,”“should,”“anticipate,”“predict,”“potential,”“continue,”“expect,”“intend,”“plan,”“proje

8、ct,”“believe,”“estimate,”and other similar or related expressions are used to identify these forward-looking statements,although not all forward-looking statements contain these words.You should not place undue reliance on forward-looking statements because they involve known and unknown risks,uncer

9、tainties,and assumptions that are difficult or impossible to predict and,in some cases,beyond Amphastars control.Actual results may differ materially from those in the forward-looking statements as a result of a number of factors,including those described in Amphastars filings with the Securities an

10、d Exchange Commission,including in our Annual Report on Form 10-K for the year ended December 31,2023,filed with the SEC on February 29,2024,in our Quarterly Report on Form 10-Q for the quarter ended March 31,2024,filed with the SEC on May 10,2024,in our Quarterly Report on Form 10-Q for the quarter

11、 ended June 30,2024,filed with the SEC on August 9,2024,and in our Quarterly Report on Form 10-Q for the quarter ended September 30,2024,filed with the SEC on November 7,2024.In particular,there can be no guarantee that our pivoting towards high-value and high-growth areas market will be successful,

12、that demand will be sufficient for us to meet our sales goal for Primatene MIST or that we will continue to experience significant sales of BAQSIMI.You can locate these reports through our website at http:/ and on the SECs website at www.sec.gov.The forward-looking statements in this presentation sp

13、eak only as of the date of the release.Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future,even if new information becomes available or if s

14、ubsequent events cause our expectations to change.The forward-looking statements in this presentation speak only as of the date of the release.Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced

15、above to reflect events or circumstances in the future,even if new information becomes available or if subsequent events cause our expectations to change.You should not rely upon forward-looking statements as predictions of future events.Although our management believes that the expectations reflect

16、ed in our forward-looking statements are reasonable,we cannot guarantee that the future results,levels of activity,performance or events and circumstances described in the forward-looking statements will be achieved or occur as forward-looking statements are inherently susceptible to uncertainty and

17、 changes in circumstances as with any projections or forecasts.Moreover,neither we,nor any other person,assume responsibility for the accuracy and completeness of the forward-looking statements.Any forward-looking statements made by us in this presentation speak only as of the date of this presentat

18、ion,and we undertake no obligation to update any forward-looking statements for any reason after the date of this presentation,except as required by law.All third-party brand names and logos appearing in this presentation are trademarks or registered trademarks of their respective holders.Any such a

19、ppearance does not necessarily imply any endorsement of the company.3Company Overview4Company Overview High Quality High Efficiency High Technology Pipeline Development Strategic Acquisitions Fully Integrated Business Model,R&D,Manufacturing and DistributionOne-StopDualStrategiesGrowth ModelThree-H

20、Focus5Extensive in-house product development capabilitiesTechnical PlatformsState-of-the-art instrumentsAnimal studiesClinical research teamControl over quality and compliance throughout the product development and manufacturing cycleFully integrated back-end manufacturing capabilitiesAPI and key ma

21、terialsDevice and key componentsComplete front-end integrationMarketingDistribution Fully Integrated Business Model:One-StopProduct DevelopmentAPI/Key Components ManufacturingUS Based Finished Product ManufacturingMarketingDistribution6Dual-Strategies Growth ModelDual-StrategiesPipeline DevelopmentP

22、rimatene MISTNDA,MDI,OTCGlucagon InjectionANDA,Highly-Purified PeptideIN NDAsInsulin AnalogBLA,rDNAStrategic AcquisitionArmstrong MDI Facility AFPrDNA FacilityBaqsimiNDA,Powder IN DeliveryPrimary-Organic GrowthSecondary-Inorganic Growth20182020On-going200320142023On-going7Three-H FocusAmphastars Man

23、agement team operates the Company to:Insist on High Quality Emphasize High Efficiency and Rely on High Technology to Develop PipelinesThe 3-H focus results in high net income margin3.5%5.5%9.0%15.5%20.7%27.3%0%5%10%15%20%25%30%35%201820192020202120222023Net Income Margin,%YearNet Income Margin,%per

24、Adjusted Net Income($Million or Specified)201820192020202120222023Revenue,x295322350438499644Net Income(GAAP)-5.748.91.462.191.4137.5Net Income,Adjusted,y10.417.831.668.0103.2175.7Net Income Margin,Adjusted,=y/x,%3.5%5.5%9.0%15.5%20.7%27.3%8Leveraging Strategic Vision&Core Strengths9Pipeline Evoluti

25、onGeneric63%Biosimilar16%Proprietary21%Generic15%Biosimilar35%Proprietary50%2021 Pipeline Projected 2026 PipelineAmphastars pipeline is projected to advance with a greater focus on proprietary and biosimilar products 10Technical Platforms NDA The Only FDA approved asthma inhaler available as OTCMult

26、iple peptide/protein products including AMP-028Insulin AnalogsBLABiosimilarInterchangeableANDA BaqsimiCharacterization ImmunogenicityEvaluationrDNAHighly-PurifiedPeptide/ProteinParticle EngineeringNovel FormulationNovel Device11In ProgressIn ProgressIn ProgressStrategic Shift Toward Proprietary&Bios

27、imilars DrugsDiabetes PortfolioBAQSIMI acquired with global footprint in+26 countriesCommerical Capabilities Expanded AMP-028Biosimilar PortfolioCapacity expansion at facilities to support future approvalsCapEx Investments&Product SupportProprietary Product Pipeline Intranasal Epinephrine 3 early st

28、age products Primatene MIST with Green*propellantAMP-002AMP-015AMP-007AMP-018(GLP-1)Expected ApprovalsInhalation pipeline to be filed and approvedInhalation Pipeline(Complex Generic)In ProgressIn Progress2023 3 Biosimilar Insulins GLP-1 ANDAIn Progress*Low global warming potential12R&D and Pipeline1

29、3 Strategic focus to make substantial R&D investments to expand our product portfolio Diverse pipeline development with flexibility and scalability for sourcing API,starting material,and research under our vertically integrated platform Emphasis and investment in R&D differentiates us from our compe

30、titors as our focus is on the long-term growth of our company R&D from API,early stage,and clinical trials and from laboratory to scale-upFocused on R&D InvestmentSelf-funded R&D investment of approximately$345 million in the recent 5 years 14Pipeline ANDAs and BLAs with Technical Barriers Generic P

31、ipeline,8 Candidates*IQVIA sales with TTM as of September 30,2024ANDA TypeProduct CodeCurrent Stage*IQVIA SalesInjectableAMP-002GDUFA Q2 2023,no FDA Action and no pending requests as of 1/10/25+$500 MillionAMP-015(Teriparatide)CRL received;planned response in Q1 2025+$600 MillionAMP-018(GLP-1)Filed,

32、GDUFA Q2 2025+$1.1 BillionInhalationAMP-007Filed,GDUFA extended to Q2 2025+$2.5 BillionAMP-016DevelopmentAMP-017Planned filing 2025AMP-023DevelopmentBiosimilarAMP-028Development+2.0 Billion15Diabetes PortfolioInterchangeable Insulin PipelineRecombinant Human InsulinInsulin AspartInsulin DegludecAMP-

33、025AMP-005AMP-004BAQSIMI,the first and only FDA approved glucagon nasal powderThe first FDA approved generic Glucagon injection kitGLP-1 ANDA filedInsulin Pipeline:-Covers the full spectrum of the insulin from rapid to long acting-AMP-004 BLA resubmitted Q4 2024-$6 Billion in IQVIA sales,70 million

34、units of both pens and vialsCommercialized Glucagon Inj.KitBAQSIMI Nasal PowderGLP-1AMP-018GLP-1 ANDA*IQVIA sales with TTM as of September 30,202416Sales and Marketing17Sales and EPS Trend18Recent Quarter Trend:Sales&Adjusted EPS195%9%3%2%7%13%14%18%8%22%51%11%9%6%5%4%14%2014NaloxoneOther PharmaPrim

35、atene MISTEpiVita KLidocaineEnox.Existing Products Provide Strong BaseNew Launches have Supported Diversification of the Revenue Base2023Insulin APIEnox.LidocaineGlucagonNaloxoneInsulin APIEpiVita K%of Total Revenue($210 MM)%of Total Revenue($644 MM)Other PharmaBaqsimi20Key Proprietary Products 21BA

36、QSIMI Strategic Rationale:A Transformative Transaction for AmphastarBAQSIMI fits well into Amphastars proprietary product strategyNovel intranasal glucagon product with IP protectionExpands diabetes portfolioBuilds upon our commercial intranasal product portfolioExpands Amphastars international foot

37、print into 26 countriesInitiate commercial sales team for BAQSIMI and future branded productsBranded product with growing sales and strong gross margin22BAQSIMI Patient ImpactGlucagon is underutilized:The American Diabetes Association(ADA)recommends that patients at increased risk for Level 2 hypogl

38、ycemia be prescribed glucagon1Approximately 7 million people are treated with insulin and only about 0.7 million(10%)2 of these patients currently utilize glucagon BAQSIMI is currently a category leader for ease in patient use:Simple nasal administration:Currently the only non-injection glucagon app

39、roved by the FDA,passively absorbed in the nose,provide lower barrier for administration than injectionReady-to-use with no reconstitution or priming requiredSmaller product size than other glucagon products,and wider temperature storage range than other glucagon injection product.1American Diabetes

40、 Association.Standards of Medical Care in Diabetes2020.Diabetes Care.2020;43(suppl 1):S1-S212.2Estimates based on IQVIA Annual TRx volume in 2022.Portability for Consumers:Amphastar will focus on BAQSIMI to better serve patients23$76M$113M$139M$153M0204060801001201401601802020202120222023$-MillionBA

41、QSIMI Worldwide Annual SalesBAQSIMI Forecast Sales Net Economic Benefit(sales minus expenses)will be booked until Amphastar takes over distribution from Lilly,on a country by country basis throughout 2024 Projected to reach peak of$250 million to$275 million Selling Expense Projected to be 15%of Baq

42、simi sales Starting in January 2025:Collaboration with Mannkind to increase Baqsimi sales footprint with their endocrinology focused sales force Adjusted EPS(1)Project$2.00 to$2.50 incremental adjusted EPS at peak(1)Adjusted EPS is a non-GAAP financial measure.Reconciliation to the nearest GAAP meas

43、ure is unavailable without unreasonable efforts.Refer to the section titled Non-GAAP Financial Measures for an explanation of non-GAAP financial measures.24Primatene MIST Primatene MIST,a proprietary and patent-protected over-the-counter epinephrine inhalation product Achieved$100mm sales target in

44、2024(1)The only FDA approved asthma inhaler available OTC,launched Dec 2018 US Adult asthma patients:20 million per CDC(2)Starting in January 2025:increase physician sampling program Development of proprietary Green(3)propellant formulation with patent pending1.Based on unaudited results 2.https:/ww

45、w.cdc.gov/asthma/most_recent_national_asthma_data.htm3.Low global warming potential$18M$52M$73M$84M$89M$101M1535557595115135201920202021202220232024$-MillionPrimatene MIST Annual Sales(1)25Highlights and Catalysts26Growth Drivers and Upcoming Milestones BAQSIMI-Increased sales footprint Primatene MI

46、ST-Advertising campaign-Increased Physician sampling program Albuterol-Launched in August 2024Expected approvals-AMP-002 CRL responded;GDUFA Q2 2023-AMP-015(Teriparatide)CRL received,planned response Q1 2025-AMP-007 GDUFA Q2 2025-AMP-018(GLP-1)GDUFA Q2 2025Key Growth Drivers in 2025 AMP-007 ANDA AMP-018 ANDA GLP-1 AMP-004 BLA resubmitted Q4 2024 Intranasal Naloxone Rx to OTC switch AMP-017 ANDAMilestonesRecent FilingsPlanned Filings in 2025