Alkermes Investor Day Presentation Deck | Slidebook.io

Alkermes Investor Day Presentation Deck

March 2021, 144 slides

alkermes investor day march | Alkermes

forward looking statements and non financial information certain statements set forth in this presentation constitute forward looking statements within the meaning of the private securities litigation reform act of as amended including but not limited to statements concerning the company expectations with respect to its current and future financial and operating performance business plans or prospects including revenue growth from its current commercial product portfolio and the addition of potential new revenue streams and the company plans and ability to manage for growth and profitability including achievement of its stated profitability targets through revenue growth expense management and optimization of its cost structure and exploration of strategic opportunities the potential therapeutic and commercial value of the company marketed products and development candidates expectations regarding patient life for the company products expectations regarding the effectiveness and cost efficiency of the company research and development strategy and the potential of the company capabilities including its molecule design and engineering capabilities plans and expectations for development activities relating to the company products and development candidates including i for alfa plans to initiate studies in mucosal melanoma and platinum resistant ovarian cancer to support potential registration further explore the potential synergistic benefits of to existing cancer treatments and pursue strategic collaborations for plans to initiate phase first in human trials and for the company other early stage programs including its program its engineered platform including and and its inhibitor platform plans to conduct proof of concept studies and or other enabling activities advance towards characterization and nomination of lead candidates and identify and initial potential indications the company expectations relating to regulatory activities and interactions including the food and drug administration target action date for the company new drug application for and plans to advance discussions on registration plans for expectations concerning commercial activities relating to the company products and product candidates including preparations for the potential commercial launch of the company cautions that forward looking statements are inherently uncertain these risks assumptions and uncertainties include among the impacts of the ongoing covid pandemic and continued efforts to mitigate its spread on the company business results of operations or financial condition the unfavorable outcome of litigation including so called paragraph litigation and other patent litigation related to any of the company products which may lead to competition from generic drug manufacturers the may not agree with the company regulatory approval strategies or components of the company including clinical trial designs conduct and methodologies manufacturing processes and facilities or the adequacy of the data or other information included in the company regulatory submissions to support the requirements for approval and may make adverse decisions regarding the company products including with respect to the for the company development activities may not be completed on time or at all the results of the company development activities may not be positive or predictive of real world results and preliminary data from ongoing studies may not be predictive of future or final data from such studies results of future studies or real world results the company and its licensees may not be able to successfully commercialize their products or support growth of revenue from such products there may be a reduction in payment rate or reimbursement for the company products or an increase in the company financial obligations to governmental payers the company products may prove difficult to manufacture be precluded from commercialization by the proprietary rights of third parties or have unintended side effects adverse reactions or incidents of misuse and those risks assumptions and uncertainties described under the heading risk factors in the company annual report on form for the year ended and in subsequent filings made by the company with the securities and exchange commission sec which are available on the sec at sec and on the company at alkermes in the investors sec filings section existing and prospective investors are cautioned not to place undue reliance on these forward looking statements which speak only as of the date hereof except as required by law the company disclaims any intention or responsibility for updating or revising any forward looking statements contained in this presentation non financial measures this presentation includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the including non net income and these non measures are not based on any standardized methodology prescribed by and are not necessarily comparable to similar measures presented by other companies reconciliations of non financial measures to the most directly comparable financial measures to the extent reasonably determinable can be found on the investors page of the company note regarding the company and its affiliates are the owners of various federal registrations and other including and is a registered of biogen used by alkermes under license any other referred to in this presentation are the property of their respective owners appearances of such other herein should not be construed as any indicator that their respective owners will not assert their rights thereto | Alkermes

scientific and business excellence focused on new approaches to creating value pops chief executive officer | Alkermes

diversified company with proven drug development and commercialization capabilities significant diverse revenues driving topline and positioned for growth pipeline of novel development candidates designed to target significant unmet needs proprietary commercial products that target large markets in addiction and psychiatry additional potential revenue streams as new products launch and grow licensed product oncology alfa phase advanced solid tumors preclinical advanced solid tumors enabling neurodegenerative and disorders agonist preclinical narcolepsy focus on profitability under review june focus on driving cost efficiencies and operating leverage while investing in the long term growth of high potential commercial and development stage products lye ors pend we a | Alkermes

evolution of alkermes strategy legacy strategy target evaluation driven by potential to add new medical value to established medications enabled rapid advancement to late stage development yielded advanced formulation science chemistry and drug delivery technologies applied to improve established pharmacology under review june | Alkermes

evolution of alkermes strategy focus management new molecules leveraging scientific capabilities new strategy focus two areas of scientific and oncology programs with validated biology rationale leverage established small molecule and protein design capabilities management utilize an integrated approach to target evaluation design development programs to provide key data early and allocate resources based on data scientific excellence molecular design medicinal chemistry and protein engineering applied to develop novel molecules to address unmet needs in and oncology by | Alkermes

value enhancement plan growth efficiency and profitability value enhancement plan establishes clear profitability targets provides framework for capital allocation decisions and of investments focuses investment on highest roi opportunities emerging from new platform incorporates feedback from shareholders external advisors and peer group data management and governance focused on growth efficiency and profitability business excellence | Alkermes

scientific business excellence drive enterprise value scientific excellence innovation driven value creation and profitability business excellence alkermes | Alkermes

consistent with alkermes purpose and values our great science deep compassion real impact collaboration at our core sharing success all is possible beyond passionate respect each voice value every person driven by trust unwavering commitment do the right thing our | Alkermes

today agenda value creation innovation growth and profitability blair executive vice president and chief operating officer alkermes new model optimizing for success executive vice president and chief medical officer focus on innovative molecular design senior vice president research oncology alfa clinical data updates vice president clinical research oncology alfa preclinical research heather senior director research oncology tumor targeted split fusion protein josh principal scientist research oncology selective inhibitors senior vice president research receptor agonists senior director research project leadership and strategy a | Alkermes

value creation at alkermes innovation growth and profitability blair chief operating officer | Alkermes

strong operational foundation to drive value creation revenues diverse and positioned for growth capital allocation focused on highest roi opportunities commitment to profitability focused on organizational efficiency and cost management strong corporate governance board refreshment independence and oversight reflects the of our expectations these expectations and the underlying assumptions and risks are set forth in alkermes the company current report on form filed with the sec on the company expressly disclaims any obligation to update or reaffirm these expectations reconciliations of non financial measures to the most directly comparable financial measures to the extent reasonably determinable can be found in the appendix of this presentation non net income | Alkermes

revenues growing commercial products serving large markets | Alkermes

topline growth and diversification reflect evolving business total revenue total revenue non proprietary revenue inclusive of developed by alkermes and licensed to biogen | Alkermes

expected growth drivers net sales patent life indications alcohol dependence prevention of relapse to dependence following detoxification schizophrenia schizophrenia bipolar i disorder potential launch in current proprietary commercial products proprietary candidate under review june licensed product royalty manufacturing revenue commercialized by biogen relapsing forms of multiple sclerosis launched in under the terms of a settlement and license agreement entered into in with pharmaceuticals alkermes granted a non exclusive license under certain patents covering including the remaining patent covering in the to market and sell a generic formulation of in the beginning sometime in or under certain circumstances subject to paragraph certification related to an anda seeking approval of a generic version a patent infringement lawsuit has been filed against the paragraph filer in response full indication and prescribing information for may be found at full prescribing information for may be found at injectable suspension | Alkermes

anticipated recovery following covid disruption monthly units covid disruptions began stabilization and recovery began alcohol dependence resumed growth as new patient starts rebounded from pandemic lows in dependence volumes have stabilized but continue to be impacted by covid related disruptions to the treatment landscape reduced patient capacity and treatment services at settings of care where people commonly undergo detoxification residential treatment centers correctional facilities mar may volume expected to regain growth as access to care improves full indication and prescribing information for may be found at unit i | Alkermes

strong growth driven by two month dose net sales mot increased in strong performance reflects favorable product characteristics inclusive of data data mot months of therapy growth of month dose reflects differentiated value proposition | Alkermes

growth outpaced atypical long acting injectable market mot growth rate branded market size lai market annual market share mot share yoy includes estimated sales and audit mot months of therapy | Alkermes

oral atypical markets represent large opportunities oral schizophrenia oral bipolar i disorder branded market size annual commercial payer market share reported sales audit factored by indication using reported indication mix sob reported sales are higher than manufacturer reported net sales because does not incorporate all gross to net expenses reported audit factored by indication using reported indication mix sob sob data reported audit converted into mot and factored by indication using reported indication mix sob sob data for the oral atypical market specific to indications data includes schizophrenia and disorder data includes and other indications switches includes add on sob data all indications due to data limitations schizophrenia data includes disorder for which will not be indicated due to data limitations data includes other indications for which will not be indicated treatment switches occur each month growth year over year size share year over year | Alkermes

growth presents additional long term revenue opportunity monthly novel oral fumarate for the treatment of relapsing forms of multiple sclerosis biogen holds exclusive license to commercialize royalty to alkermes on net sales oral market mar may june data i | Alkermes

near term expected revenue drivers current proprietary commercial products alcohol dependence prevention of relapse to dependence following detoxification expected net sales schizophrenia under review june schizophrenia bipolar i disorder potential launch royalty stream commercialized by biogen relapsing forms of multiple sclerosis launched in these expectations and the underlying assumptions and risks are set forth in the company filed with the sec on the company expressly disclaims any obligation to update or reaffirm these expectations full indication and prescribing information for may be found at full prescribing information for may be found at | Alkermes

capital allocation focused on organizational efficiency and cost management | Alkermes

conducted comprehensive analysis of operations and cost structure and implemented significant changes comprehensive cost structure review optimization initiatives undertaken conducted extensive review of operations and cost structure both internally and with external advisors to identify potential areas for efficiencies and savings completed peer to identify areas of focus for potential saving initiatives assessed resource requirements across multiple functions to determine optimal in house strategy evaluated enterprise system processes that could drive long term efficiencies commercial infrastructure reorganization addiction refocused to increase emphasis on alcohol dependence psychiatry infrastructure realigned to drive efficiencies and reallocate resources to support potential launch of highest roi development programs determined optimal balance of internal external resources a leverage identified efficiency opportunities implementation ongoing | Alkermes

disciplined capital allocation supports highest roi priorities support profitable commercial portfolio prepare for anticipated launch of advance alfa develop next generation of pipeline candidates drive operating margins of commercial business and focus on profitability create value through innovation and position for future growth | Alkermes

disciplined capital allocation supports highest roi priorities support profitable commercial portfolio awareness and marketing campaign for alcohol dependence indication drive growth through continued focus on two month dose plus addiction sales infrastructure psychiatry sales infrastructure shared commercial services support market access and key account management infrastructure patient access services digital marketing capabilities policy initiatives in addiction and serious mental illness alkermes | Alkermes

disciplined capital allocation supports highest roi priorities prepare for anticipated launch of commercial launch life cycle management complete sales force hiring complete early in illness phase study support patient access programs initiate planned pediatric program commence planned marketing campaign initiate physician outreach payer interactions under review june | Alkermes

disciplined capital allocation supports highest roi priorities advance alfa initiate studies to support potential registration pathways in mucosal melanoma and platinum resistant ovarian cancer continued enrollment in artistry dose expansion evaluating subcutaneous anti tumor activity continue to build objective response data in multiple tumor types in artistry and artistry go | Alkermes

disciplined capital allocation supports highest roi priorities develop next generation of pipeline candidates complete phase enabling activities initiate phase first in human study initiate phase study nominate candidate to the clinic oncology lead candidate generation advance lead candidate identification | Alkermes

value enhancement plan includes evaluation of strategic opportunities evaluation of strategic opportunities monetization of non core assets strategic collaboration for and other oncology assets operational financial elements of legacy drug monetization of royalty delivery drug manufacturing business revenue streams from third party products platforms intellectual property preclinical and clinical assets outside of strategic portfolio risk sharing product development structures | Alkermes

strong corporate governance board refreshment independence and oversight | Alkermes

maintaining strong board of directors and corporate governance board composition and refreshment board skills and support strategy and long term value creation appointed new independent directors since new directors bring financial operational and oncology three longer serving directors have recently retired or announced their retirement from the board average director tenure years continued board refreshment efforts announced for proposal to shareholders to declassify the board to be included in proxy statement board oversight of value enhancement plan formed financial operating committee to oversee implementation of value enhancement plan compensation committee incorporated objective performance based elements related to value enhancement plan into company long term incentive plan for executives does not include two directors retiring at close of the company annual general meeting gender wormer | Alkermes

board refreshment lead independent director more than years of experience in pharmaceutical drug development and commercialization former of a experience in institutional investment management value creation and transactional matters former and executive director of mellon investments experience in finance strategic planning corporate development and investor relations current and treasurer of labs former of iron mountain nancy experience as a practicing physician veteran journalist advisor to policy organizations former chief medical editor at news former corporate communications at a significant management and operations experience former coo of alkermes experience in product development regulatory affairs and commercialization of pharmaceuticals former chief marketing officer at former executive at significant experience in financial reporting and compliance former and treasurer of former of experience in finance and accounting strategic planning investor relations and business development former of former executive at new director in announced retirement as of the close of the alkermes annual general meeting of shareholders global experience in the industry including in business development former of corporation former president of alkermes experience in scientific research and current president chief of research and development at formerly at pops leadership experience and deep industry knowledge gained through years in the industry current of alkermes board member of and nancy experience building and leading life sciences companies and in overseeing key operational and commercial functions former and of vertex former coo of | Alkermes

diversified company with proven drug development and commercialization capabilities significant diverse revenues driving topline and positioned for growth pipeline of novel development candidates designed to target significant unmet needs proprietary commercial products that target large markets in addiction and psychiatry additional potential revenue streams as new products launch and grow licensed product oncology alfa phase advanced solid tumors preclinical advanced solid tumors enabling neurodegenerative and disorders agonist preclinical narcolepsy focus on profitability under review june focus on driving cost efficiencies and operating leverage while investing in the long term growth of high potential commercial and development stage products injectable suspension a trolly mat enabling | Alkermes

developing new treatments to address unmet patient need in and oncology optimizing for success executive vice president and chief medical officer alkermes | Alkermes

alkermes objective develop innovative medicines with clear value propositions relative to current and anticipated future standards of care in and oncology based on strong biological rationale embodied in new molecular entities that leverage alkermes advanced small molecule drug development and protein engineering capabilities developed efficiently and cost effectively with rigorous governance rooted in alkermes patient centric approach to developing medicines | Alkermes

evolution to novel drug development with differentiated and contemporary approach employ integrated approach to target selection development and management with continuous evaluation of medical and economic value leverage advanced medicinal chemistry and protein engineering capabilities to develop novel molecular entities with strong intellectual property protection risk programs with front end loaded development plans utilizing forward and reverse translational medicine strategies | Alkermes

integrated approach to target evaluation and portfolio assessment biology rationale commercial opportunity unmet need high value development candidate regulatory pathway technical feasibility clinical pathway alkermes | Alkermes

efficient development designed to expedite answers to critical go no go questions preclinical research development clinical development early demonstration of preclinical proof of concept in disease relevant models thorough molecular design feasibility assessment in depth drug metabolism and human dose prediction embedded reverse translational tailoring the medication to the patient establishment of scale up path accelerate generation of decision driving data innovative clinical trial designs including adaptive and or basket approaches comprehensive strategy expeditious and cost efficient execution early engagement with regulators to establish clear and expeditious regulatory pathways strong foundational intellectual property and pragmatic approach to indication expansion | Alkermes

portfolio management and investment data driven decision making established success criteria and stage gates throughout development process enables kills and risks overall investment cross functional integrated governance to enable strategic decision making extends beyond legal commercial and manufacturing incorporates perspectives into decision making recently discontinued programs program reason for discontinuation phase of development suboptimal pharmaceutical properties phase oncology failure in third party competitive program enabling epigenetic target oncology strategic portfolio fit stress signaling target research proof of concept not achieved preclinical preclinical | Alkermes

strategic planning and execution integrates ongoing feedback from external advisory boards dedicated and oncology scientific advisory boards comprised of leading experts in medicinal chemistry translational medicine and academic science offer insight into current scientific state of the art approaches provide independent program assessments identify opportunities to risk and or accelerate programs engage routinely with internal teams to address emerging challenges clinical advisory boards comprised of global thought leaders in areas of therapeutic focus validate clinical trial designs support selections advise on regulatory strategy and expedited pathways provide insights on disease landscape | Alkermes

alkermes new approach is designed to increase the probability of technical regulatory and commercial success design medicines with compelling value propositions accelerate time to data and decision milestones establish and adhere to clear go no go criteria efficiently bring important new medicines to patients | Alkermes

focus on innovative molecular design harnessing alkermes scientific technical capabilities senior vice president research | Alkermes

alkermes molecular design biology rationale commercial opportunity unmet need high value development candidate strong biology rationale capabilities focused within defined scientific platforms targets externally validated and vetted with scientific advisors potential opportunity for first in class or best in class therapies structure activity insight guides molecular design regulatory pathway technical feasibility technical feasibility clinical pathway integrated capabilities in medicinal chemistry protein engineering and molecular modeling utilized to address technical challenges | Alkermes

medicinal chemistry or protein engineering approach for each target medicinal chemistry protein engineering guided internal medicinal chemistry design internal synthesis enables work in difficult to make space access to specialized chemistry capabilities protein degrader technology encoded libraries close integration with modeling team to guide protein design advanced protein engineering capabilities engineering tumor targeting platform fusion proteins | Alkermes

sophisticated purpose built state of the art toolbox for advanced molecular design molecular dynamics binding energy calculations proprietary molecular design platform with on the fly in silico predictions protein design computational optimization artificial intelligence for generative design machine designed molecular structures machine learning models in silico assay panel with pharmacology and safety predictions i | Alkermes

scientific platforms serve as the foundation to strategy and focus in and oncology oncology synaptic dysfunction immune modulation inhibitors agonist engineered alkermes | Alkermes

synaptic dysfunction a versatile platform across neurology and psychiatry synaptic loss is the best current pathologic correlate of cognitive decline improving synaptic function is critical to slow progression and preserve cognitive and functional abilities in neurological disorders targeting synaptic integrity and function at different levels synapse structure restore integrity and number of synapses synapse function increase efficiency of synapses and restore function in deficient synapse environment improve efficiency of supporting cells such as microglia and astrocytes baxter nat rev front decline disorders | Alkermes

development candidates emerging from platform mechanism programs and potential indications selective inhibitors pro synaptic orphan indications in and neurodegenerative disorders follow on candidate non orphan indications in neurodegenerative and neuropsychiatric spaces increase of and pro synaptic frontotemporal dementia with precursor mutations and other variants restoration of abnormal receptor agonist narcolepsy and indications with excessive daytime sleepiness fatigue or attention cognition issues histone repressor of repressor element silencing transcription factor | Alkermes

immune modulation in oncology based on engineered have pleiotropic effects and can act on every phase of the cancer immunity cycle alkermes is focusing on based therapies designed to increase visibility of tumor cells to immune system increase tumor killing potential of and cells mutation fusion remove suppressive signals in the tumor modern based drugs need a high degree of engineering to reduce side effects improve enhance efficacy natural killer journal of cancer cycle | Alkermes

immune modulation portfolio of engineered technical challenge alkermes protein engineering solution key anti tumor mechanisms alfa tumor targeted split enhanced efficacy efficacy of limited by expansion of cells and other undesirable effects fusion of circularly permuted with the subunit resulting in only activating intermediate affinity has low tolerability when given systemically efficacy of limited by a protein that binds to separate inactive tumor targeted engineered for which activity is not subunits assemble and activate in the tumor blocked by suppressive mechanisms expansion of cells and cells minimal expansion of cells drive responses at the tumor site through potent activation of and cells enhance mediated anti cancer immune responses reduce cell exhaustion potential cancer types solid tumors including melanoma platinum resistant ovarian cancer solid tumors including pancreatic breast colon and ovarian cancer tumor inhibitor resistant tumors | Alkermes

focus and discipline integral to portfolio advancement discovery phase enabling phase phase phase phase alfa intravenous dosing alfa subcutaneous dosing neurology orphan agonist inhibitors neurology neuropsychiatry non orphan inhibitors frontotemporal dementia tumor targeted split inhibitors oncology oncology | Alkermes

alfa a novel engineered variant clinical data updates from artistry and artistry trials vice president clinical research oncology a | Alkermes

today agenda harnessing the potential of the pathway advancing a differentiated alfa molecular design clinical development strategy clinical data overview artistry intravenous dosing focus on melanoma and platinum resistant ovarian cancer artistry subcutaneous dosing subcutaneous recommended phase dose and preliminary objective response upcoming data and next steps alkermes | Alkermes

is sterically occluded from binding to the high affinity receptor suppress immune response cells cell cell cell extracellular domain of a receptor fight cancer cells cells for illustrative purposes only regulatory cell cell natural killer cell high affinity receptor bearing cell intermediate affinity receptor bearing cell | Alkermes

key differentiation parameters support broad potential utility validate molecular design demonstrate anti tumor activity create dosing flexibility support broad potential utility demonstrated selective expansion of and cells demonstrated minimal changes in peripheral regulatory cells in both intravenous and subcutaneous administrations single agent activity observed with combination activity observed in combination with anti both and in hard to treat tumors plans to progress into registration enabling studies only variant in development identified based on safety and anti tumor activity achieved first objective response activity observed with in experienced patients combination activity observed with combination activity observed with multiple agents in preclinical studies may offer dosing flexibility renal cell carcinoma recommended phase dose pharmacodynamic inhibitors net | Alkermes

clinical development strategy focused on difficult to treat cancers with clear unmet need approved tumor types with anti unapproved tumor types with anti post failure with anti mucosal melanoma addition to standard of care new potential therapies designed to address important unmet needs where inhibitors are not successful granted orphan drug designation platinum resistant ovarian cancer inhibitors | Alkermes

artistry intravenous dosing study | Alkermes

demonstrated anti tumor activity in melanoma and renal cell carcinoma dose tumor type prior therapy lines best overall response decrease in target lesions time on therapy weeks continuing therapy mucosal melanoma mucosal melanoma unconfirmed cutaneous melanoma melanoma vaccine renal cell carcinoma renal cell carcinoma placebo awaiting confirmation awaiting confirmation awaiting confirmation yes no yes yes yes data cutoff march reported after data extraction partial response recommended phase dose | Alkermes

responses in melanoma | Alkermes

high unmet needs remain for treatment of refractory melanoma melanoma burden mucosal melanoma fifth most common type of cancer in the prevalence new cases in estimated deaths in the in due to melanoma melanoma patients with distant metastases have a year survival rate of incidence has risen faster than almost any common cancer type in the last years rare and aggressive type of melanoma occurring in mucosal membranes that is often diagnosed late due to non specific symptoms and anatomic location poor prognosis when compared with cutaneous melanoma year survival rates as low as for mucosal melanoma mucosal melanoma is largely resistant to traditional therapies response rates with chemotherapy are poor and targeted therapies such as inhibitors are usually not an option for mucosal melanoma immune inhibitors have lower response rates for mucosal melanoma than for cutaneous melanoma was recently granted orphan drug designation for mucosal melanoma epidemiology of melanoma in ward editors cutaneous melanoma etiology and therapy codon publications chapter available from codon primary mucosal melanomas a comprehensive review combatting mucosal melanoma recent advances and future perspectives melanoma published efficacy and safety of alone or in combination with in patients with mucosal melanoma a pooled analysis be eat location parle lene at years | Alkermes

artistry melanoma cohort focused on unmet need key inclusion criteria artistry study melanoma cohort progressed on immune inhibitor anti with or without anti targeted agent as appropriate inhibitor if protocol defined efficacy response criteria achieved triggered two stage expansion cohort second stage of enrollment underway artistry two stage stage enroll more if stage refractory melanoma expansion total | Alkermes

artistry responses in experienced melanoma patients tumor type line of therapy new cutaneous melanoma partial response evaluation of evaluation of evaluation of ongoing to with time on study weeks artistry part efficacy preliminary data ongoing study out of evaluable patients with scans total responses observed with tumor shrinkage mucosal melanoma and cutaneous melanoma majority of patients are ongoing as of march data cut inhibitors intravenous progressive disease partial response recommended phase dose stable disease reported after the data cut off and awaiting confirmation data cut off march experienced seers fee roe sails a | Alkermes

artistry dose expansion cohort case study year old male cutaneous melanoma patient diagnosis melanoma diagnosed on study activity started remains on treatment prior treatment line therapy vaccine change in target lesion from duration mos best response cycle cycle target lesion size stable disease reduction partial response reduction treatment related aes last dose of prior treatment manageable with no dose modifications anemia and fever grade intermittent grade and grade patient continues on therapy as of march per criteria reported after the data cut off and awaiting confirmation progressive disease stable disease data cut off march | Alkermes

for melanoma advancing toward registration stage demonstrate activity mucosal cutaneous identify unmet need experienced patients mucosal melanoma orphan designation advance clinical studies to support potential registration path in mucosal melanoma engage with regulatory authorities on registration plans experienced of | Alkermes

responses in heavily treated platinum resistant ovarian cancer patients in combination with | Alkermes

high unmet needs remain for treatment of ovarian cancer ovarian cancer burden limited treatment options second most common gynecological cancer prevalence cases in leading cause of gynecologic cancer related deaths in the year survival rate for stage ovarian cancer of median overall survival mos for platinum resistant ovarian cancer is less than months standard of care median progression free survival months standard of care surgery platinum based chemotherapy followed by and or inhibitor as maintenance many become platinum resistant refractory and progress months after completion of platinum based chemotherapy few treatment options post platinum chemotherapy in one study of non platinum chemotherapy objective response rate was and median progression free survival was months anti have been shown to be ineffective for treatment of ovarian cancer efficacy in ovarian cancer is for high expression maintenance expression | Alkermes

artistry in combination with responses in heavily treated ovarian cancer tumor type line of therapy artistry part efficacy ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer ovarian cancer evaluation of evaluation of evaluation of evaluation of ongoing out of patients with scans patients experienced an objective response confirmed and unconfirmed patients remain on study as of march data cut time on study weeks intravenous progressive disease partial response stable disease complete response data cut off march alkermes | Alkermes

artistry in combination with responses in platinum resistant ovarian cancer table patient experience in reduction of tumor burden age prior therapies lines reduction of target lesions overall response investigator assessment response from time on therapy weeks artistry part efficacy pac gem doc pac doc doc tam pac pac pac gem top pac pac cap normalized from to at cycle normalized from to at cycle reduced from to at cycle awaiting confirmation reduced from to at cycle normal at at cap doc gem pac albumin hydrochloride tam top complete response partial response unconfirmed stable disease continuing on therapy due to node shrinkage to short axis per criteria data cut off march | Alkermes

artistry in combination with case study year old ovarian cancer patient artistry part efficacy diagnosis on study tumor shrinkage high grade serous ovarian cancer status unknown status wild type platinum resistant prior treatment change in target lesions from cycle stable disease reduction cycle stable disease reduction cycle stable disease reduction line therapy duration mos best response cycle partial response reduction last dose not evaluable patient has remained on treatment for months treatment related aes manageable with no dose modifications majority aes grade and grade elevated alt and grade anemia notes continues on therapy as of march per criteria reported after the data cut off and awaiting confirmation progressive disease partial response stable disease data cut off march | Alkermes

advancing fast to market opportunity in platinum resistant ovarian cancer advance discussions on registration plans with regulatory agencies initiate study with intravenous in combination with complete enrollment subcutaneous dose expansion cohort initiated ongoing studies designed to accumulate additional data artistry intravenous phase artistry subcutaneous phase artistry tumor phase ion head and neck phase | Alkermes

clinical update for artistry selection of recommended phase dose | Alkermes

induced dose dependent selective expansion of circulating and cells cells fold change from cells fold change from fold change from provided greater expansion of cells and cells relative to subcutaneous intravenous once every days once every days natural killer regulatory cells tags | Alkermes

artistry in combination with case study year old female with high grade serous diagnosis on study activity high grade serous diagnosed status positive status negative status low prior treatment line therapy duration mos best response pac started remains on treatment subcutaneous change in target lesion and levels from total target lesions size cycle reduction partial response treatment related aes level unit reduction manageable with no known dose modifications last dose of prior treatment hypotension and dehydration grade and multiple events patient continued on therapy as of march per criteria awaiting confirmation progressive disease partial response platinum resistant ovarian cancer tumor mutational burden homologous recombination deficiency pac multiple injection site reactions grade data as of march | Alkermes

advancing across key domains submission of data for presentation at upcoming congresses artistry updated safety and efficacy data artistry dose and initial efficacy and safety data advance ongoing studies advance interactions with regulatory authorities initiate studies in mucosal melanoma and platinum resistant ovarian cancer to support potential registration pursue strategic collaborations to expand development program | Alkermes

alfa preclinical research paving the clinical development path heather director research program lead oncology | Alkermes

immune modulation portfolio of engineered technical challenge alkermes protein engineering solution key anti tumor mechanisms alfa tumor targeted split enhanced efficacy efficacy of limited by expansion of cells and other undesirable effects fusion of circularly permuted with the subunit resulting in only activating intermediate affinity has low tolerability when given systemically efficacy of limited by a protein that binds to separate inactive tumor targeted engineered for which activity is not subunits assemble and activate in the tumor blocked by suppressive mechanisms expansion of cells and cells minimal expansion of cells drive responses at the tumor site through potent activation of and cells enhance mediated anti cancer immune responses reduce cell exhaustion potential cancer types solid tumors including melanoma platinum resistant ovarian cancer solid tumors including pancreatic breast colon and ovarian cancer tumor inhibitor resistant tumors | Alkermes

oncology goal activate innate and adaptive immune responses to drive tumor cell death antigen identification and presentation recognition by immune system immune system activation endogenous other immune cell mediated tumor cell death dendritic cell presenting antigen activated cells and cells activated cells attacking tumor tumor killing and release of antigens cells cells aes | Alkermes

oncology goal activate innate and adaptive immune responses to drive tumor cell death enhanced antigen identification and presentation cell death chemotherapy radiation inhibitors targeted agents growth factor inhibitors immune system activation endogenous other immune cell mediated tumor cell death dendritic cell presenting antigen activated cells and cells activated cells attacking tumor tumor killing and release of antigens cells cells aes | Alkermes

oncology goal activate innate and adaptive immune responses to drive tumor cell death antigen identification and presentation amplified immune system activation immune cell mediated tumor cell death recognition by immune system dendritic cell presenting antigen activation and expansion cells and cells activated cells attacking tumor tumor killing and release of antigens cells cells | Alkermes

oncology goal activate innate and adaptive immune responses to drive tumor cell death enhanced antigen identification and presentation cell death amplified immune system activation enhanced immune cell mediated tumor cell death chemotherapy radiation inhibitors targeted agents growth factor inhibitors dendritic cell presenting antigen activation and expansion cells and cells activated cells attacking tumor tumor killing and release of antigens cells cells | Alkermes

preclinical efforts inform the clinical development strategy preclinical research clinical research molecular design confirmed selectivity demonstrated efficacy first in human studies signal seeking studies receptor selectivity maintained potency cell cell expansion minimal expansion of combination with anti mouse determined recommended phase dose from safety and data responses in multiple tumor types and in combination with anti pivotal studies combination with demonstrate efficacy with complementary mechanisms growth factor pathway inhibitors chemotherapy radiation other agents sab at a oft | Alkermes

agents that induce immunogenic cell death may offer synergistic advantages in combination with chemotherapy or radiation agents that induce immunogenic cell death include immune inhibitors growth factor pathway inhibitors cytotoxic chemotherapies radiation activated cancer fighting cells pharmacotherapy | Alkermes

agents that induce immunogenic cell death may offer synergistic advantages in combination with combination with growth factor pathway inhibitors chemotherapy or radiation immune inhibitors anti ongoing clinical trials anti growth factor pathway inhibitors tyrosine kinase inhibitors anti antibodies cytotoxic chemotherapies radiation activated cancer fighting cells pharmacotherapy alkermes | Alkermes

inhibition of growth factor pathways induces immunogenic cancer cell death combination with growth factor pathway inhibitors growth factor pathway inhibitors anti growth factor receptors immune cell trafficking to tumor tissue activity of immune suppressive cells tumor cell survival growth tumor cell metastasis tumor angiogenesis growth factors support several mechanisms that promote cancer cell survival and metastasis inhibition of tumor growth factor pathways is a validated therapeutic approach in oncology cell mediated immune responses emerging from inhibition of tumor growth factors may be augmented by ability to activate cancer fighting immune cells immunogenic cancer cell death release of cancer antigens cell activation and expansion cancer metastasis rev physiology oncology mechanism of inhibitor action accessed march ref | Alkermes

in combination with growth factor pathway inhibitors enhanced cancer fighting mechanisms in mouse tumors combination with growth factor pathway inhibitors cells in tumor cells in tumor dendritic cells in tumor dendritic cells in tumor in tumor in tumor macrophages in tumor macrophages in tumor vehicle in combination with either or not shown resulted in increased immune activation and decreased immune suppression in tumors alkermes internal data on file the mouse of was used in mouse tumor model a a | Alkermes

in combination with growth factor pathway inhibitors enhanced cancer fighting mechanisms in mouse tumors combination with growth factor pathway inhibitors tumor gene expression in mice treated with and vehicle angiogenesis gene expression in combination with either or not shown resulted in enhanced angiogenesis blockade and activated multiple immune pathways alkermes internal data on file the mouse of was used in mouse tumor model a | Alkermes

enhanced the anti tumor efficacy of in mouse tumors tumor growth inhibition overall survival combination with growth factor pathway inhibitors days vehicle complete responses days in combination with either or not shown resulted in enhanced tumor suppression and survival relative to groups similar results observed with a mouse surrogate of which is a selective inhibitor of the angiogenesis factor alkermes internal data on file the mouse of was used in mouse tumor model | Alkermes

agents that induce immunogenic cell death may offer synergistic advantages in combination with combination with radiation chemotherapy or radiation immune inhibitors anti ongoing clinical trials anti growth factor pathway inhibitors tyrosine kinase inhibitors anti antibodies cytotoxic chemotherapies radiation activated cancer fighting cells pharmacotherapy alkermes | Alkermes

combination with radiation exploring potential synergistic benefits to chemotherapy or radiation mediated mechanisms chemotherapy and radiation can have positive effects on anti cancer immunity both can directly induce tumor cell lysis and lead to immunogenic cancer cell death chemotherapy and radiation can enhance innate anti tumor immune responses however chemotherapy and radiation can also have negative effects on the immune system decreased lymphocyte and counts which can negatively impact response to therapy immune suppression due to increased in the tumor ongoing preclinical collaborations leverage specialized translational models to explore ability to augment chemotherapy radiation driven anti cancer mechanisms while countering the negative impacts cell death dis dar front a front trier cancer cancer res responses therapy | Alkermes

research collaborations with leading institutes explore further potential clinical utility of principal investigator and institute research collaborations clinic college of medicine kin wong health james welsh the university of cancer center and lan university of medical center soc standard of care preclinical collaboration to study combinations of with multiple immune inhibitors in individualized humanized melanoma models preclinical collaboration to study novel combinations of with soc chemotherapy in mouse lung tumor models preclinical collaboration to study combinations of with novel radiation approaches in mouse models of immune inhibitor resistance preclinical collaboration to study the effects of on the human tumor in multiple solid tumor types in | Alkermes

preclinical efforts inform the clinical development strategy preclinical research clinical research molecular design confirmed selectivity demonstrated efficacy first in human studies signal seeking studies receptor selectivity maintained potency cell cell expansion minimal expansion of combination with anti mouse determined recommended phase dose from safety and data responses in multiple tumor types and in combination with anti pivotal studies combination with demonstrate efficacy with complementary mechanisms potential expansion of clinical program growth factor pathway inhibitors chemotherapy radiation other agents new combinations new indications new collaborations a sab at oft | Alkermes

tumor targeted split fusion protein program principal scientist research oncology | Alkermes

immune modulation portfolio of engineered technical challenge alkermes protein engineering solution key anti tumor mechanisms alfa tumor targeted split enhanced efficacy efficacy of limited by expansion of cells and other undesirable effects fusion of circularly permuted with the subunit resulting in only activating intermediate affinity has low tolerability when given systemically efficacy of limited by a protein that binds to separate inactive tumor targeted engineered for which activity is not subunits assemble and activate in the tumor blocked by suppressive mechanisms expansion of cells and cells minimal expansion of cells drive responses at the tumor site through potent activation of and cells enhance mediated anti cancer immune responses reduce cell exhaustion potential cancer types solid tumors including melanoma platinum resistant ovarian cancer solid tumors including pancreatic breast colon and ovarian cancer tumor inhibitor resistant tumors | Alkermes

is a highly potent with diverse anti tumor effects is a protein consisting of two linked subunits and individual components are non functional anti tumor activity is driven through activation of both innate and adaptive immune compartments and production of robust anti tumor efficacy observed in preclinical studies cancer front cancer res august cell effector function antigen processing remodeling angiogenesis ref natural killer cell natural killer cell cell cell studies fee | Alkermes

potential clinical utility limited by severe toxicities clinical evaluation limited due to severe toxicities associated with systemic exposure to and its narrow therapeutic index systemic administration associated with the potential for rapid development of lethal inflammatory syndrome ongoing efforts in seeking to develop strategies for tumor localized delivery gene therapy viral delivery primarily based on it administration alkermes design intentions for engineered harness the therapeutic potential of address delivery challenges associated with it approaches avoid toxicity associated with systemic exposure to cancer front cancer res august cancer res index | Alkermes

alkermes design approach build functional in the tumor through engineered tumor targeted subunits key design considerations and challenges split to create functionally inactive subunits to be directed to the tumor engineer subunits to address inherent stability challenges in production and enhance the affinity of non linked and subunits identify unique tumor targeting antigen and generate proprietary antibodies certain proteins exhibit increased expression in tumors relative to normal tissue and can be leveraged to target to tumors with high specificity produce novel engineered tumor targeted fusion proteins using proprietary antibodies subunits can be fused to proprietary antibody against unique tumor antigen fusion protein engineering non targeted engineered inactive subunit tumor targeting antibody tumor targeted subunits | Alkermes

tumor site specific assembly of functional designed to avoid systemic exposure treat with targeted subunit wait for clearance from circulation treat with targeted subunit results in functional in the tumor sequentially timed injections of tumor targeted subunits reduce systemic exposure to functional thereby potentially reducing associated toxicities targeted accumulation of functional in the tumor may improve anti tumor activity tumor targeted subunit tumor targeted subunit functional i | Alkermes

preclinical data demonstrated differential clearance of targeted subunits to minimize systemic exposure tumor and serum from pet imaging of tumor targeted subunits subunit concentration subunit concentration tumor blood hours tumor blood hours tumor clearance of targeted subunits was than serum clearance facilitating tumor specific assembly alkermes internal data on file a a | Alkermes

preclinical data demonstrated accumulation of tumor targeted split subunits in the tumor pet imaging of tumor hours post treatment single chain non targeted targeted subunit targeted subunit molecules in tumor high signal non targeted targeted targeted non targeted targeted low signal alkermes internal data on file murine tumors in mice percent of injected dose per gram of tissue | Alkermes

sequential administration of split subunits resulted in dose dependent pharmacodynamic response in preclinical study vehicle tumor targeted subunits low dose tumor targeted subunits high dose vehicle single chain non targeted targeted targeted subunit subunit non targeted non targeted subunit subunit alkermes internal data on file humanized mice | Alkermes

tumor targeted split advancing toward preclinical proof of concept and cell line development engineer tumor targeted subunits fused to proprietary tumor targeting antibody demonstrate that tumor targeted subunits are retained in tumors with expected kinetics demonstrate that sequentially administered subunits combine to form functional and drive dose dependent production in humanized mice complete humanization of tumor targeting antibodies ongoing characterize lead candidates and preclinical proof of concept studies planned initiate cell line development | Alkermes

| Alkermes

selective inhibitors in synaptic dysfunction senior vice president research | Alkermes

alkermes inhibitor portfolio introduction to and synaptic dysfunction biological rationale for the program established epigenetic control of synapse formation and function modulated by inhibitors limitations of first generation agents as therapeutics alkermes novel rationally designed to selectively target the complex first nominated development candidate from inhibitor portfolio leveraging proprietary chemistry and insight to other potential compounds and indications including frontotemporal dementia with precursor mutations histone repressor of repressor element silencing transcription factor | Alkermes

synapses play a vital role in brain function learning and memory synapse points of communication between neurons formation of synapses occurring throughout a healthy person normal dendritic spines presynaptic axon dendritic spine presynaptic axon dendrite axon reduced dendritic spine density | Alkermes

span multiple neurological diseases independent of underlying pathology many neurological disorders are characterized by synaptic pathology which includes synapse loss abnormal density of dendritic spines aberrant synaptic signaling and plasticity targeting the synapse may slow progression and preserve cognitive and functional abilities in a range of diseases neuropsychiatric neurodegenerative bipolar spectrum disorder frontotemporal dementia disease epilepsy schizophrenia disease major depressive disorder disease cochlear retinal autism spectrum disorders syndrome fragile syndrome dementia in down syndrome tuberous sclerosis complex syndrome | Alkermes

epigenetic control of knockout or inhibition of histone increases the number of synapses conversely reduces the number of synapses inhibitors function by enhancing the acetylation of histones this opens up the chromatin and increases accessibility of for transcription of multiple genes associated with closed chromatin histone tail acetyl group inaccessible gene inactive histone guan nature open chromatin accessible gene active a | Alkermes

class i function in association with protein complexes that determine their activity family consists of enzymes class complexes with sin a sin a sin class class class class i doc a complex is directly involved in repression of genes in neuronal tissue ill | Alkermes

alkermes novel selectively target bound in the complex alkermes has designed inhibitors binding to specifically in the complex selectivity achieved by exploiting a key pocket present in in the complex fuller | Alkermes

alkermes proprietary inhibitors design goals selectivity selectively inhibit complex safety demonstrate favorable hematological safety brain penetration exhibit desired brain exposure | Alkermes

a novel selective inhibitor candidate for the treatment of neurodegenerative and disorders | Alkermes

achieved alkermes compound design goals selectivity selectively inhibited complex safety demonstrated favorable hematological safety brain penetration exhibited desired brain exposure fold selectivity other class i complexes minimal effects in and in preclinical in assessments unbound ratio in rat dog cerebrospinal fluid alkermes data on file | Alkermes

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