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1、Evaluate Vantage2023 PreviewBy Amy Brown,Edwin Elmhirst and Joanne Fagg|DECEMBER 20222 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.ContentsFOREWORD 3INNOVATION AND REGULATION 4MONEY MARKETS AND M&A 10CLINICAL CATALYSTS IN 2023 163 Evaluate Vantage 2023 Preview Copyr
2、ight 2022 Evaluate Ltd.All rights reserved.ForewordAfter the market downturn of 2021,2022 brought little respite to beaten-up biopharma companies.There are some hopes for an improvement in conditions in 2023,though few are expecting a dramatic recovery.This is partly because the era of cheap money i
3、s over.As interest rates rise,the high-stakes world of drug development offers the sort of gambles that many investors no longer need to take.At the same time,the rising cost of capital only makes life more expensive for cash-burning biopharma groups.For those in need of funds,the start of 2023 is l
4、ikely to be tough.Many believe an improvement towards the end of the year to be the best-case scenario.Others are bracing for a more protracted slump,caused by global instability and entrenched inflation that is dampening economic growth around the world.This backdrop should emphasise the so-called“
5、safe haven”attributes of the more established end of the pharmaceutical sector.This means that larger developers could do well next year,particularly if the threat of Zantac litigation continues to fade.Still,several big pharma names are under pressure to fill looming revenue gaps,and the strategic
6、direction and leadership of companies like GSK and Sanofi will be hot topics.Acquirers will be keen to make the most of compressed valuations in 2023,and opportunistic moves will surely abound.The question of whether bigger deals might occur was answered as this report went to press,with Amgens$28bn
7、 takeover of Horizon.Many are hoping that the coming months will see an uptick in more sizeable transactions.No such explosion is expected in the IPO world,with the window effectively shut.This means that the venture world is also likely to slow again in 2023.After years of plenty,the private world
8、is well stocked,although all eyes are on valuations could 2023 be the year of the down round?Life is harder on the public markets.A big proportion of listed developers will be starting the year trading below cash,and some will not see the start of 2024.Perhaps 2023 will see a resurgence reverse merg
9、ers.The sector also feels ripe for investor activism.Biopharma desperately needs to deliver clinical successes in 2023,to help remind investors why this sector can be worth the risks.Areas of focus next year include Alzheimers disease,where Eisai and Lilly are hoping to succeed where Biogen failed.A
10、nd respiratory syncytial virus could become a battleground,with several big names starting to contest the space.Investors will also be looking for signs that the nascent gene therapy and gene editing fields are maturing and gaining the confidence of regulators.The cancer field,which has attracted hu
11、ge amounts of money over the past five years,also needs to show that it can deliver new mechanisms.Not everything needs to work,but in a bear market bright spots are desperately needed.At least the regulatory climate looks set to improve:Evaluate Omnium predicts an uptick in FDA approvals next year,
12、after a slowdown in 2022.Evaluate Vantages preview of 2023 seeks to describe these and other challenges facing biopharma in the coming months,as well as the many opportunities that will present themselves.For the first time,the report includes the thoughts of almost 150 public and private investors,
13、bankers and industry employees who responded to our poll.Read on to discover their opinions on what might be coming next year for IPOs and M&A,as well as several other data-driven analyses of sector performance.We also include Evaluate Pharmas forecasts of the fastest-growing drugs,most valuable R&D
14、 projects and most important regulatory approvals all of which will shape the biopharma sector in 2023,and beyond.All data pulled and analysed in early November 2022.4 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.INNOVATION AND REGULATION5 Evaluate Vantage 2023 Previ
15、ew Copyright 2022 Evaluate Ltd.All rights reserved.Growing biopharmas top line:drugsMAbs and jabs are set to dominate 2023s biggest-selling drugs,in terms of forecast annual revenues as well as new sales generated over 2022.Four products make it into both tables,a result of the huge demand and prici
16、ng power that these brands command.Mercks PD-1-targeted Keytruda is projected to become the worlds top-selling medicine next year,and remarkably is also seen adding almost$3bn in new sales in 2023.The checkpoint inhibitor is currently approved in 38 settings across 18 tumour types;perioperative use
17、is expected to drive much of the growth for the PD-(L)1-targeted mechanism in the coming years.Keytruda will take the top spot from the Covid vaccine Comirnaty,which itself supplanted Humira in 2021.Biosimilars against the Abbvie anti-rheumatic will arrive in the US in January 2023,20 years after Hu
18、mira was first launched;how quickly sales will be eroded by lower-cost competition is an open question.Covid remains an uncertainty next year.Forecasts have been coming down over 2022,and for now the world is well stocked with pandemic products.Much still depends on what the virus does in the coming
19、 months or years,in terms of rendering existing treatments ineffective.For now,these Covid products are seen pushing drugs like Regenerons Eylea and Novo Nordisks Ozempic names that are likely to feature in coming years out of the top 10.The diabetes drug Ozempic does make it into the fastest grower
20、s,with a forecast$2bn in new sales on the way in 2023.Lillys newly launched Mounjaro is the product to watch,however.An incredibly strong launch has sent forecasts shooting higher,and the biggest risk for now is that Lilly will not be able to make enough to keep up with demand.INNOVATION AND REGULAT
21、IONTop selling drugs in 2023Biggest new sales generators:drugs055Keytruda(Merck&Co)Comirnaty(Pfizer/Biontech)Humira(Abbvie/Eisai)Paxlovid(Pfizer)Eliquis(Bristol Myers Squibb/Pfizer)Opdivo(Bristol Myers Squibb/Ono Pharmaceutical)Dupixent(Sanofi)Stelara(Johnson&Johnson/Mitsubishi Chemical)S
22、pikevax(Moderna)Biktarvy(Gilead Sciences)Global 2023 sales($bn)0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Keytruda(Merck&Co)Dupixent(Sanofi/Regeneron)Ozempic(Novo Nordisk)Mounjaro(Eli Lilly)Darzalex(Johnson&Johnson)Wegovy(Novo Nordisk)Opdivo(Bristol Myers Squibb/Ono Pharmaceutical)Skyrizi(Abbvie)Eliquis(Bristo
23、l Myers Squibb/Pfizer)Rinvoq(Abbvie)Global new sales in 2023($bn)Note:includes sales booked by global partners,where relevant.Source:Evaluate Pharma and Evaluate Vantage.6 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.Growing biopharmas top line:companiesSales of Comi
24、rnaty and the Covid antiviral Paxlovid are expected to keep Pfizer at the top of the table next year,in terms of prescription drug sales.Even the might of Keytruda cannot help Merck&Co,in second place,close the gap.But with waning demand for pandemic products,Pfizers pole position is not likely to l
25、ast much longer.The list of companies with fast-growing top lines looks quite different from the top 10 by sales.Novo Nordisk and Lilly feature because of high demand for the type 2 diabetes and obesity agents that were highlighted in the previous analysis Ozempic,Wegovy and Mounjaro.Huge expectatio
26、ns behind the last of those,Lillys newly launched dual GLP-1/GIP agonist,mean that the group is likely to move into the top 10 companies by sales in coming years.Several non-big pharma names feature in this second analysis.CSL is riding surging demand for immunoglobulins,while last years acquisition
27、 of Vifor is also giving the Australian vaccines and blood products group a boost.Grifols is another big player in the blood plasma and immunoglobulin space.The Japanese developer Daiichi Sankyo has the Astrazeneca-partnered Enhertu to thank for its growing top line.The Her2-directed antibody-drug c
28、onjugate is making fast inroads into breast cancer on the back of highly impressive clinical data.Astrazenecas success in oncology more widely is largely responsible for its showing here,as well as the groups move into rare diseases via its 2020 Alexion acquisition.That deal brought the fast-growing
29、 brand Ultomiris,which is sold for various autoimmune conditions.INNOVATION AND REGULATION007080PfizerMerck&CoJohnson&JohnsonNovartisAbbvie Roche Bristol Myers SquibbAstrazenecaSanofiGSKForecast prescription drug sales in 2023($bn)01234Novo NordiskAstrazenecaEli LillyBristol Myers SquibbJ
30、ohnson&JohnsonAmgenCSLNovartisGrifolsDaiichi SankyoNew prescription drug sales in 2023($bn)Biggest companies in 2023Biggest new sales generators:companiesSource:Evaluate Pharma and Evaluate Vantage.7 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.Waiting in the wings:b
31、iggest launchesAlzheimers disease will be a major focus for biopharma followers next year,as Eisai and Lilly attempt to get their respective amyloid plaque-clearing antibodies onto the market.The read out of donanemabs pivotal trial in mid-2023 is likely to be one of the biggest events for the secto
32、r next year.Securing full reimbursement in the US is also likely to take time,should FDA approvals be won.This uncertainty makes it hard to estimate how quickly sales of lecanemab and donanemab might build.The same can be said for Sarepta and Roches gene therapy for Duchenne muscular dystrophy;predi
33、cting demand is hard owing to lack of precedents,and securing reimbursement for what will be a very expensive product is bound to present a problem.Regulatory risks should also not be ignored.Another space on which opinions are divided on the size of the opportunity is respiratory syncytial virus,an
34、 infection that vaccine makers have finally managed to hit after years of trying.GSK is seen as ahead here although Pfizer is close on its heels,and late-stage readouts from the likes of J&J and Moderna are due soon.Apelliss progress with its geographic atrophy project will be closely watched after
35、the company rattled investors by filing more data with the FDA during the review process,a move that delayed the PDUFA date by three months.Only one of the companys two phase 3 trials hit,and while a green light is expected a positive outcome is far from assured.Under normal circumstances an advisor
36、y committee would have reviewed the submission,but the FDAs ophthalmic committee has not resumed its panel hearings in the wake of Covid,making the verdict even harder to call.INNOVATION AND REGULATIONBiggest potential launches of 2023ProjectCompanies involvedDescription Status 2028e sales Lecanemab
37、Eisai/BiogenAnti-amyloid-beta MAb for Alzheimers diseasePDUFA Jan 6,2023(accelerated approval)$3.0bnSRP-9001Sarepta/Roche Gene therapy for Duchenne muscular dystrophyPDUFA May 29,2023(accelerated approval)$2.2bnIntravitreal PegcetacoplanApellis Complement factor C3 inhibitor for geographic atrophy P
38、DUFA Feb 26,2023;EMA filing planned for December 2022$2.0bnDonanemabLilly Anti-amyloid-beta MAb for Alzheimers diseaseFDA decision on accelerated approval expected in February 2023$1.9bnRSVPreF3 OA(GSK3844766A)GSKVaccine for older adults against respiratory syncytial virusPDUFA May 3,2023.European a
39、pproval likely mid-late 2023$1.8bnEpcoritamabAbbvie/GenmabAnti-CD20 bispecific for lymphomasPDUFA May 21,2023(possibly accelerated decision),filed in EU,for diffuse large B cell lymphoma$1.7bnZuranolone Biogen/SageGaba A modulator for major depressive disorder and postpartum depressionNDA for MDD an
40、d PPD to be completed by YE22 with potential for priority review.Analysts assume mid-late 2023 US approval$1.5bnMirikizumabLilly Anti-IL-23 MAb in development for ulcerative colitis and CrohnsPDUFA date May 2023(ulcerative colitis).MAA filed Q122,decision expected 2023$1.2bnEtrasimodPfizerS1P 1 modu
41、lator for ulcerative colitisRegulatory filings planned for 2022.Analysts assume late 2023 launch$1.2bnSotaterceptMerck&CoActivin receptor 2a regulator for pulmonary arterial hypertensionFiling expected early 2023.Fast track/breakthrough designations in place in US and Europe.Analysts assuming late 2
42、023 launch$1.0bnSource:Evaluate Pharma and Evaluate Vantage8 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.Waiting in the wings:R&D projectsMoving on to projects coming behind those already filed with regulators,two novel antibody-drug conjugates from Daiichi Sankyo s
43、tand out.The Japanese group hopes to build on the success of Enhertu,and a pivotal readout early next year for a second Astrazeneca-partnered project,datopotamab deruxtecan,is a big event for both companies and the ADC space more widely.Elsewhere,talquetamab was one of the stars of Ash in 2022 and a
44、ll eyes are on how J&J decides to push forward here either seeking an early approval for the bispecific in a small use or waiting for controlled data in earlier myeloma settings.Karuna delivered a rare win in the psychiatric space in 2022 with its novel schizophrenia project KarXT.More data are expe
45、cted in 2023 and the company plans to file for approval mid-year.Some huge expectations lie behind the agent,and while the company has said it wants to launch the drug itself in the US many believe Karuna is a takeover target.Intellia and Regeneron,meanwhile,are waiting for the FDA to green light th
46、e start of clinical trials of NTLA-2001 in the US.The agencys caution around certain gene-editing projects is a theme to watch for 2023.Finally,tiragolumab is included here despite huge doubts around the anti-Tigit mechanism.Forecasts for the Roche MAb have more than halved since the first phase 3 r
47、eadouts disappointed,but with Merck&Co also heavily invested here this approach remains of interest for now.INNOVATION AND REGULATIONOnes to watch:biopharmas most valuable R&D projectsProjectCompanies involvedDescription NPVDatopotamab deruxtecanDaiichi Sankyo/AstrazenecaTrop-2 targeted antibody-dru
48、g conjugate;first phase 3 data due H123$9.6bnNTLA-2001Intellia/Regeneron Crispr-Cas9 gene editing therapy for hereditary transthyretin amyloidosis;further cuts of ph1 data due over 2023,pivotal plans awaited$6.3bnNipocalimabJohnson&JohnsonFcRn antagonist for autoimmune conditions;ph3 in myasthenia g
49、ravis ongoing,further pivotal plans awaited$5.4bnmRNA-1647ModernaCytomegalovirus vaccine;ph3 ongoing$4.7bnTalquetamabJ&J/GenmabT-cell redirecting bispecific targeting GPRC5D for multiple myeloma;mid-stage readouts due over the year$4.5bnKarXTKaruna TherapeuticsM1/M4-muscarinic agonist for schizophre
50、nia;pivotal programme ongoing,further data and US filing slated for 2023$4.2bnAficamtenCytokinetics Cardiac myosin inhibitor;ph3 data in hypertrophic cardiomyopathy due H223$3.7bnTiragolumabRocheAnti-Tigit MAb;further overall survival readouts due in 2023$3.2bnPatritumab deruxtecan(U3-1402)Daiichi S
51、ankyoHer3 targeted antibody-drug conjugate for for breast and lung cancer;potentially pivotal ph2 data due 2023$2.9bnCTX001(exagamglo-gene-autotemcel)Crispr/VertexCrisr-Cas9 gene editing therapy for sickle cell disease and beta-thalassaemia;US and European filings anticipated by Q123$2.4bnSource:Eva
52、luate Pharma and Evaluate Vantage9 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.The regulatory environment:reading the runesNext year should see a return to the 50+novel approvals that has become the norm in recent years,after a dip in 2022.This is according to Evalu
53、ate Omnium,which has pinpointed 57 agents with a high probability of reaching the finish line in 2023.Should this come to pass it would mean that the apparent slowdown in 2022 was just a blip rather than any tapping of the breaks by the FDA.This should provide some reassurance to a sector heading in
54、to another tough year on the financing front.Much focus in 2023 is likely to fall on the accelerated approval pathway,where the FDA has been tightening up.The agency and industry have been criticised for foot-dragging when it comes to demanding and providing confirmatory evidence,but it is becoming
55、clear that this permissive period is over.Data provided by the agency point to a big drop in the number of conditional approvals granted,with 2022 way down on previous years.It is worth noting that 2020 was boosted by 16 applications by Merck&Co for alternative Keytruda dosing regimens.Even removing
56、 these,the 29 accelerated approvals granted that year is likely to be the peak.The FDA is making it clear to developers that confirmatory phase 3 trials must be well under way before the accelerated pathway can be considered.It is also ensuring that drugs are pulled swiftly from the market should fi
57、rm evidence not arrive.This tightening means that smaller developers hoping to use this pathway to generate early revenues must think again.And further change might also be on the way.More extensive reform of the accelerated approval pathway was dropped in the recent user fee reauthorisation,but adv
58、ocates have every intention of trying again in the coming months.MONEY,MARKETS AND M&ATracking US approvals:back to business in 2023?FDA tightens up on accelerated approvals Note:2022 count to end September.2020 inflated by 16 accelerated applications by Merck&Co for alternative Keytruda dosing regi
59、mens.Source:FDA.Note:Count includes novel therapeutics approved by both CDER and CBER.Source:FDA and Evaluate Pharma for 5th year sales.0200FDA approvals5th year sales combined0202530500222023FDA approval count5th year sales($bn)Potential/predicted approvals030354045
60、505320002020212022Accelerated approval count ConvertedNot Yet ConvertedWithdrawn10 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.MONEY,MARKETS AND M&A11 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.Stoc
61、k market performanceThe protracted downturn from the peak of the market in early 2021 looks to have bottomed out,at time of writing in November 2022,although sentiment is expected to remain depressed throughout 2023.The war in Ukraine and rising global interest rates will remain live issues next yea
62、r,providing a poor backdrop for the high-risk drug development sector.Even so-called“safe haven”big pharma names could struggle next year,with investors concerned about the impact on future earnings from drug price reform in the US.As a result of the November mid-terms the US has a divided governmen
63、t,dashing industrys hopes that a Republican majority could weaken certain aspects of the Biden administrations Inflation Reduction Act(IRA),enacted in August 2022.The Democrats ability to strengthen the law,for example by expanding the number of drugs included in new Medicare negotiations,has also b
64、een blown.Either way,the fallout of the IRA remains hard to predict,and figuring out its longer-term implications will be a big focus in 2023.It is smaller,cash-hungry developers that will take the brunt of inclement market conditions next year,however.Should the poor financing climate persist throu
65、ghout 2023 few harbour hopes for any improvement in the first half of the year the sector will inevitably see more cash conservation efforts.This means portfolio prioritisation,job cuts and deals struck out of desperation and a rise in investor activism.Encouragingly,a survey conducted by Evaluate V
66、antage for this report found that most sector followers believe that the US biotech market has already hit the bottom.A sizeable proportion of responders think that the market still has further to fall in 2023,however.All of this suggests that those developers already struggling with financing will
67、find little respite in the coming months.MONEY,MARKETS AND M&AXBIRSPXLV-60%-40%-20%0%20%40%60%80%100%01/202003/202005/202007/202009/202011/202001/202103/202105/202107/202109/202111/202101/202203/202205/202207/202209/202211/2022Share price movement from 02/01/2020Stock market performance 0
68、070Already hasQ1 2023Q2 2023Q3 2023Q4 20232024+VotesNote:Survey conducted in early November 2022.Reponses are from public and private investors,bankers and other biopharma industry employees.Note:This chart shows three equal weighted exchange traded funds tracking US listed companies.XBI includes bi
69、otech stocks from across the market cap spectrum.XLV includes healthcare equipment and medtech as well as pharmaceutical companies.RSP includes all stocks in the S&P 500.When will the US biotech market hit the bottom?12 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.Th
70、oughts on the IPO windowThe health of the IPO market is a strong proxy for investors appetite for high-risk biotech,and it is clear from 2022s record that sentiment is poor.By the end of the third quarter 16 pure-play drug developers had floated on Western exchanges,a big drop on the previous few ye
71、ars.Eight managed to raise more than$100m,pointing to some latent support for certain offerings,although these flotations required substantial insider support to get away.In our survey,41%of respondents expect to see more of these larger offerings in the US next year.This proportion is not vastly ah
72、ead of the 31%of people who think 2023 is likely to look the same as 2022,however.It is comforting that the smallest proportion of responders reckon the IPO market will retrench further.When it comes to Europe most respondents expect the situation to improve in 2023,although the continents IPO marke
73、t could not get much worse.At time of writing only one biotech,Aelis Farma,had managed to float in the region in 2022.Even if volumes stay the same next year,as 39%of people in our poll reckon,this will still equal a dire financing situation.The US market will inevitably recover first,which means th
74、at Europe-based developers with public ambitions and sufficient support will likely have to turn to Nasdaq rather than Euronext.MONEY,MARKETS AND M&AEight pure-play drug developers raised more than$100m at IPO in 2022.How many flotations of this size will we see in 2023?One pure-play drug developer
75、floated in Europe in 2022.What will we see in this region in 2023?Note:Survey conducted in early November 2022.Reponses are from public and private investors,bankers and other biopharma industry employees.0070MoreAbout the sameFewerVotes0070MoreAbout the sameFewerVotes13 Evalua
76、te Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.IPOs:historical performance and future trendsThose looking to apportion blame for the bursting of the biotech bubble frequently point fingers at the IPO market,and the flood of early-stage companies that arrived in 2020 and 2021
77、.A look at the disappointing performance of recent new issues shows why investors have cooled,although it should be remembered that the whole market is also significantly down.By comparison,the class of 2022 is faring fairly well,although many of the groups in this cohort have yet to reach milestone
78、s.Small deals are a feature of the downturn:six of 2022s 16 IPOs raised less$20m,and four of these groups are already trading more than 60%below their offer price.These developers have struggled to hold onto their valuations post-float because in most cases the IPO failed to satisfy funding needs.Un
79、til the market starts supporting larger raises again,it is hard to see the volume of flotations rising.The type of companies being supported by investors next year is also a trend to monitor,in terms of assessing any potential fallout from the IRA.Critics contend that the new law makes small-molecul
80、e investments less attractive than those in biotech products,because the former can be selected for Medicare price negotiations seven years after approval,and the latter after 11 years.Some companies have already blamed this disparity for deprioritising certain assets.Certain investors claim to be c
81、hanging how they value opportunities.If the IRA really is shifting allocation of capital,this will turn up in the data.To kick off the monitoring of this trend Evaluate Vantage split recent IPOs into technology type biotech or small molecule a measure that is also a proxy of sorts for venture invest
82、ment trends.The split over the last five years is almost even,with 48%of new issues built on the former and 52%on the latter.That proportion will shift towards biotech if the aforementioned concerns prove accurate.Performance of annual IPO cohorts,to November 2022INNOVATION AND REGULATION0%10%20%30%
83、40%50%60%70%80%BiotechSmall molecule chemistryProportion of IPOs by technology200212022Note:IPOs of pure-play drug developers on Western exchanges only.Sectors like medtech and digital health excluded.Note:IPOs of pure-play drug developers on Western exchanges only.Only includes companies
84、 still trading,so excludes M&A or reverse merger targets,bankruptcies etc.Tracking the impact of IRA:IPOs by company technology-20%-40%-60%-80%-100%0%20%40%60%80%100%share price increase from float2018(n=55)2019(n=45)2020(n=73)2021(n=96)2022(n=16)Max value within1.5*IQRMin value within1.5*IQRUpper Q
85、uartileLower QuartileMeanMedian14 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.Venture funding:circle the wagonsThe venture capital world has also been feeling the pain of the biotech bear market,and 2023 is likely to see further retrenchment.Many firms are well stoc
86、ked for now,but with the investment world“risk-off”,the days of largesse are over.The shutting of the IPO window has also had a big impact on the private world.Deep-pocketed crossover investors who supported large pre-flotation rounds have retreated,and traditional venture funds cannot pass on their
87、 portfolio companies as quickly.Make no mistake the financing wheels were spinning fast in 2021.A remarkable 16%of venture-backed companies received more than one round of financing that year,a figure driven by the wide-open IPO window.In 2022 that number is sitting at 5%,and while the year is not y
88、et over,the absence of flotations means it is unlikely to move higher.The second chart maps out another trend that will be monitored next year the average number of venture financing rounds a company receives before floating or being bought.With the IPO window all but shut,being able to exit an inve
89、stment via acquisition has become an even juicier prospect for these funds.Again,2022 is not yet over but investors have had to wait longer for this years buyouts,with developers having received almost four rounds of investment ahead of a deal.Venture firms will not want to see that line creeping hi
90、gher.MONEY,MARKETS AND M&AThe money wheels are slowing down Heading for the exit Note:all data concerns deals and financings struck by global,pure-play drug developers only.Sectors like medtech and digital health are excluded.2022 data to mid-November.Source:Evaluate Pharma.00500600Number
91、 of companies receiving VC funding%companies receiving multiple rounds08%10%12%2%4%6%14%16%18%200212022Number of companies%of companies receiving multiple rounds00.511.522.533.54M&AIPOMean number of VC rounds prior to exit200212022Exit year15 Evaluate Vantage 2023 Preview Copyr
92、ight 2022 Evaluate Ltd.All rights reserved.M&A:potential targets2022 was not a terrible year for M&A but,at the time of writing in late November it had not delivered the big bang that many were hoping for.A sizeable deal looks to be brewing,however,with Horizon Therapeutics confirming preliminary in
93、terest from Amgen,Johnson&Johnson and Sanofi.With three marketed products Horizon has long been considered desirable,and disagreement over valuation is probably the only barrier to this happening.The developer was highlighted as a target by respondents to our poll;Biogen and Vertex were also popular
94、 choices,and all would represent very sizeable transactions.Analysts reckon Horizon could go for$25-30bn,which would make it the biggest biopharma deal since Astrazeneca announced its takeover of Alexion in late 2020.A good proportion of respondents to our survey were hopeful that 2023 would be a bi
95、gger year for M&A than 2022,although most expect more of the same.That means a healthy flow of mid-sized transactions,as well as plenty of deals done out of desperation.With valuations still at rock bottom more developers will be faced with the choice of giving up or selling out.Next year is also li
96、kely to see a good number of reverse mergers,particularly if the IPO window remains closed.Also consider the cash-rich preclinical companies that amassed funds in the boom but are now struggling to keep investors interested.Could they come to the rescue of some more advanced but cash-strapped develo
97、pers?Another possibility is a rise in collaborations between biotechs and the firms that are typically contracted to carry out the work could this era of cash conservation prompt some risk-sharing up and down the supply chain?The big deals are always the big story,however.A buyout of the other most
98、named target highlighted in our poll,Seagen,looks increasingly unlikely.The stock is back to levels seen before rumours of Merck&Cos interest surfaced.Biogen is considered a target for its Alzheimers link;it is notable that Lilly is the only big pharma group with a potential Alzheimers project anywh
99、ere near the market.MONEY,MARKETS AND M&AWestern drug makers have spent just over$40bn on M&A so far this year.What might 2023 look like?Which big developers should/could get acquired in 2023?Note:Survey conducted in early November 2022.Reponses are from public and private investors,bankers and othe
100、r biopharma industry employees.0070Less M&A spend(cost of capital is rising and small deals will persist)About the same(bolt-ons are the way forward)A big one is coming(the patent clif approaches)Votes16 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.CLINICA
101、L CATALYSTS IN 202317 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.Big cap events2023 clinical catalysts:the big developers Project CompanyDetail Timing Clinical trial IDTiragolumabRochePh3(+Tecentriq)Skyscraper-01 OS readout in NSCLC,anti-Tigit MAbInterim Q1,final H
102、2NCT04294810Fidanacogene elaparvovecPfizerPh3 Benegene-2 haemophilia B gene therapyQ1NCT03861273CrovalimabRochePh3 Commodore-2 in complement inhibitor-naive PNH ptsEarly 2023?(primary completion Jan)NCT04434092Rybelsus(oral semaglutide)Novo NordiskPh3 Pioneer Plus(25mg and 50mg dosing)in type 2 diab
103、etes,Ph3a Oasis 1(50mg)in obesityH1NCT04707469NCT05035095NipocalimabJ&J Ph2 in rheumatoid arthritis,Ph3 in myasthenia gravisH1(RA)Primary completion in Nov for myastheniaNCT04991753NCT04951622Datopotamab deruxtecanDaiichi Sankyo/AstrazenecaPh3 Tropion-Lung01 in 2nd/3rd-line NSCLCH1NCT04656652Dupixen
104、tSanofi/RegeneronPh3 Boreas in COPDH1NCT03930732EnhertuDaiichi Sankyo/AstrazenecaPh3 Destinty-Breast06 in Her2-low 2L+metastatic breast cancer,includes a Her2-0 cohort,primary is PFSH1NCT04494425Mounjaro(tirzepatide)Lilly Ph3 Surmount 2,3&4 in obesity dataQ2NCT04657003NCT04657016NCT04660643Semagluti
105、deNovo NordiskPh3 STEP-HFpEF in HFpEF+obesityQ2?(primary completion Mar)NCT04788511MK-7684(vibostolimab)Merck Coformulation with Keytruda,Ph2 Keyvibe-002 2L NSCLC,anti-Tigit MAb2023(primary completion May)NCT04725188DonanemabLillyConfirmatory Ph3 Trailblazer-Alz 2(filed for accelerated approval)in A
106、lzheimers diseaseMid yearNCT04437511Wegovy(semaglutide injection)Novo NordiskPh3 Select CVOT cardiovascular outcomes study in obesity(important given Lillys impressive obesity data with tirzepatide)Set to complete mid yearNCT03574597Rybrevant+lazertinibJ&JPh3 Mariposa-2 in 2L EGFR-mutant NSCLCMid ye
107、arNCT04988295PF-07252220(BNT161)Pfizer/BiontechPh3,quadrivalent modified mRNA influenza vaccine 2023(primary completion June)NCT05540522TalquetamabJ&J/GenmabFurther readouts likely from Ph2 MonumenTAL-1 trial in relapsed/refractory multiple myelomaH2NCT04634552CLINICAL CATALYSTS IN 202318 Evaluate V
108、antage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.Big cap eventscontinued2023 clinical catalysts:the big developers Project CompanyDetail Timing Clinical trial IDMounjaro(tirzepatide)LillyPh3 Summit in HFpEF+obesityH2(primary completion Nov)NCT04847557Tolebrutinib SanofiPh3 Gemini-
109、1&Gemini-2 in relapsing MSH2(primary completion Aug/Sep)NCT04410978NCT04410991ImlunestrantLilly Ph3 Ember in ER+ve/Her2-ve breast cancerH2?(primary completion June)NCT04120493Patritumab deruxtecan(U3-1402,Her3-DXd)Daiichi SankyoPotentially pivotal Ph2 Herthena-Lung01 in late-line EGFR+NSCLC2023(prim
110、ary completion Nov)NCT04619004KisqaliNovartis Adjuvant HR+breast cancer,Ph3 Natalee studyInterim at end of 2022,final in 2023NCT03701334Camizestrant+CDKiAstrazenecaPh3 Serena-6,1L metastatic Hr+/Her2-breast cancer ESR1m,oral serdQ4NCT04964934Opdivo+YervoyBristol Myers SquibbPh3 Checkmate-9DW 1L live
111、r cancerQ4NCT04039607EpcoritamabAbbvie/GenmabPh3 Epcore DLBCL-1 trial,relapsed/remitting setting(could support full approval)Late 2023NCT04628494SabatolimabNovartisPh2 Stimulus-AML1,Tim3 project in unfit acute myeloid leukaemia2023NCT04150029IptacopanNovartis Ph3 Applause-IgAN(proteinuria data for a
112、ccelerated filing)in IgAN,Ph3 Appear-C3G in C3 glomerulopathy2023NCT04578834NCT04817618CLINICAL CATALYSTS IN 2023Source:Evaluate Pharma,company statements and clinicaltrials.gov.19 Evaluate Vantage 2023 Preview Copyright 2022 Evaluate Ltd.All rights reserved.2023 clinical catalysts:outside of the bi
113、g developers Project CompanyDetail Timing Clinical trial IDPemvidutide Altimmune Ph2 Momentum,obesity data,GLP-1/glucagon dual receptor agonistQ1NCT05295875KarXTKaruna TherapeuticsSecond Ph3 data(Emergent-3)due;US filing planned mid-2023Q1NCT04659161MagrolimabGileadInterim look at Ph3 Enhance in 1L
114、high-risk MDSEarly 2023NCT04313881Elahere(mirvetuximab soravtansine)ImmunogenConfirmatory Mirasol study(approved under accelerated approval)in FR-high,platinum-resistant ovarian cancerEarly 2023NCT04209855mRNA-1647ModernaPh3 CMVictory ongoing,cytomegalovirus vaccine2023(primary completion Jan)NCT050
115、85366mRNA-1345ModernaPivotal ConquerRSV Ph3 1st interim analysis in adults(60 yrs)with RSVWinter 22/23NCT05127434TarpeyoCalliditasPh3 Nefigard Part B eGFR data at 2 years(confirmatory data,approved under accelerated approval)in IgANH1NCT03643965Vax-24VaxcytePh2 in adults aged 65 and over in pneumoco
116、ccal disease(24-valent vaccine)H1NCT05297578AMT-130UniqureUS Ph1/2 1-2yr dataQ2NCT04120493PNT2002Point Biopharma/LantheusPivotal Ph3 Splash in metastatic castration-resistant prostate cancerMid yearNCT04647526MVA-BN RSVBavarian NordicPh3 in adults(60 yrs)with RSVMid yearNCT05238025EvobrutinibMerck K
117、GaAPh3 evolutionRMS 1&2 in relapsing MSH2(primary completion Sep)NCT04338022NCT04338061AficamtenCytokinetics Ph3 Sequoia-HCM in obstructive hypertrophic cardiomyopathyH2NCT05186818ALN-HBV02(VIR-2218)Alnylam/Vir BiotechnologyPart B of March trial,in combo with VIR-3434,and in triple combo with VIR-34
118、34+interferon in hepatitis BH2NCT04856085VERVE-101VerveFirst(ex-US)data from ph1 Heart-1 trial in familial hypercholesterolaemiaH2NCT05398029SparsentanTraverePh3 Protect eGFR data at 2 years(confirmatory data,filed for accelerated approval)in IgANH2NCT03762850AtrasentanChinookPh3 Align proteinuria d
119、ata in IgAN(for accelerated filing)Q3NCT04573478SRP-9001Sarepta/RocheConfirmatory Embark study(filed for accelerated approval)in Duchenne muscular dystrophyEnd of 2023NCT05096221NTLA-2001Intellia Therapeutics/RegeneronFurther updates from Ph1 in ATTR amyloidosis2023NCT04601051Other eventsCLINICAL CA
120、TALYSTS IN 2023Source:Evaluate Pharma,company statements and clinicaltrials.gov.Evaluate HeadquartersEvaluate Ltd.3 More LondonLondon SE1 2REUnited KingdomT+44(0)20 7377 0800Evaluate AmericasEvaluatePharma USA Inc.60 State Street,Suite 1910Boston,MA 02109USAT+1 617 573 9450Evaluate Asia PacificEvalu
121、ate Japan KKHolland Hills Mori Tower 2F5-11-2 Toranomon,Minato-kuTokyo 105-0001,JapanT+81(0)70 4131 |EvaluatePharma EvaluateVantageEvaluate provides trusted commercial intelligence for the pharmaceutical industry.We help our clients to refine and transform their understanding of the past,present and
122、 future of the global pharmaceutical market to drive better decisions.When you partner with Evaluate,our constantly expanding solutions and our transparent methodologies and datasets are instantly at your disposal,along with personalised,expert support.Evaluate gives you the time and confidence to t
123、urn understanding into insight,and insight into action.offers a global view of the pharmaceutical markets past,present and future performance with best-in-class consensus forecasts to 2028,unique broker forecasts,and the application of proprietary methodologies to support highly robust,detailed and
124、accurate analysis.provides a complete,dynamic view of development risk and commercial return across all phases of the clinical lifecycle including early-phase and privately-developed drugs not covered by analysts forecasts.With product-specific data including Predicted Peak Sales,Probability of Tech
125、nical and Regulatory Success(PTRS),R&D Costs,Net Present Value,Time-to-Peak and more,Evaluate Omnium makes it easier than ever to quantify and compare risk and return across the full pipeline landscape.is curated by epidemiology experts and delivers comprehensive,global epidemiological data in granu
126、lar detail,on a highly interrogatable platform.Customers have access to impartial data for 15 therapeutic areas,and over 230 indications and 9,500 sub-populations across 27 core markets(up to 49 for some countries).provides a transparent and trusted source of market intelligence and consensus foreca
127、sting for the global medical device and diagnostic landscape,using the same proprietary methodologies as Evaluate Pharma.Customers can quickly understand how the market views products and portfolios and where their opportunities,risks and priorities lie.are specialists in solving unique and complex
128、biopharma pipeline,portfolio and commercialisation challenges with best-in-class datasets,powerful analytical capabilities,and deep therapy and commercialisation expertise.provides award-winning,thought-provoking news and insights on current and future developments in the pharma,biotech and medtech industries,and is the only news service underpinned by Evaluates commercial intelligence and data.Subscribe to Evaluate Vantage Daily News