Certara Investor Day Presentation Deck

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#1CERT Nasdaq Listed CERTARAO accelerating medicines Investor Day 2021#2Disclaimer Numerical figures in the presentation have been subject to rounding adjustments. Accordingly, numerical figures shown as totals in various tables may not be arithmetic aggregations of the figures that precede them. Trademarks and Service Marks The Certara design logo, "Certara," and our other registered or common law trademarks, service marks or trade names appearing in this presentation are our property. Solely for convenience, our trademarks, tradenames, and service marks referred to in this presentation appear without the ®, TM, and SM symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights to these trademarks, tradenames, and service marks. This presentation contains additional trademarks, tradenames, and service marks of other companies that are the property of their respective owners. We do not intend our use or display of other companies' trademarks, trade names or service marks to imply relationships with, or endorsement or sponsorship of us by, these other companies. Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, that reflect the Company's current views with respect to, among other things, the Company's operations and financial performance. Forward-looking statements include information concerning possible or assumed future results of operations, including descriptions of our business plan and strategies. These statements often includes words such as "anticipate," "expect," "suggest," "plan," "believe," "intend," "project," "forecast," "estimates," "targets," "projections," "should," "could," "would," "may," "might," "will," and other similar expressions. We base these forward-looking statements or projections on our current expectations, plans and assumptions, which we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at the time. The forward-looking statements are based on our beliefs, assumptions and expectations of future performance, taking into account the information currently available to us. These statements are only predictions based upon our current expectations and projections about future events. Actual results may differ materially from those described in the forward-looking statements and are subject to a variety of assumptions, uncertainties, risks and factors that are beyond our control, including the acceptance of model-informed biopharmaceutical discovery and development by regulators, continued growth in R&D spend by our customers, outsourcing of services and technology by our customers, and the other factors detailed under the captions "Risk Factors" and "Special Note Regarding Forward-Looking Statements" and elsewhere in our Securities and Exchange Commission filings, and reports, including the Prospectus filed with the SEC on December 14,2020. New risks emerge from time to time and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Any forward-looking statement made by us in this presentation speaks only as of the date of this presentation and is expressly qualified in its entirety by the cautionary statements included in this presentation. We undertake no obligation to publicly update or review any forward- looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable laws. You should not place undue reliance on our forward-looking statements. Non-GAAP Financial Information This presentation contains "non-GAAP measures" that are financial measures that either exclude or include amounts that are not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles ("GAAP"). Specifically, we make use of the non-GAAP financial measures adjusted EBITDA, adjusted EBITDA margin, adjusted net income, and adjusted diluted EPS, which are not recognized terms under GAAP and should not be considered as alternatives to net income (loss) and GAAP EPS as measures of financial performance or cash provided by operating activities as a measure of liquidity, or any other performance measure derived in accordance with GAAP. The presentation of this measure has limitations as an analytical tool and should not be considered in isolation, or as a substitute for our results as reported under GAAP. Because not all companies use identical calculations, the presentations of these measures may not be comparable to other similarly titled measures of other companies and can differ significantly from company to company. Adjusted EBITDA represents net income (loss) excluding interest expense, provision (benefit) for income taxes, depreciation and amortization expense, intangible asset amortization, equity-based compensation expense, acquisition and integration expense and other items not indicative of our ongoing operating performance. Adjusted EBITDA margin represents adjusted EBITDA divided by revenue. Adjusted net income and adjusted diluted EPS exclude the effect of the same items noted above with respect to adjusted EBITDA from GAAP net income (loss) and GAAP EPS, respectively, as well as adjust the provision for income taxes for such charges. You should refer to the appendix at the end of this document for a reconciliation of these non-GAAP measures in specific periods to their most directly comparable financial measures calculated and presented in accordance with GAAP for those periods. Management uses various financial metrics, including total revenues, income from operations, net income, and certain non-GAAP measures, including those discussed above, to measure and assess the performance of the Company's business, to evaluate the effectiveness of its business strategies, to make budgeting decisions, to make certain compensation decisions, and to compare the Company's performance against that of other peer companies using similar measures. In addition, managem believes these metrics provide useful measures for period-to-period comparisons of the Company's business, as they remove the effect of certain non-cash xpenses and other items not indicative of its ongoing operating performance. Management believes that these metrics are helpful to investors, analysts, and other interested parties because they can assist in providing a more consistent and comparable overview of our operations across our historical periods. In addition, these measures are frequently used by analysts, investors, and other interested parties to evaluate and assess performance. In evaluating adjusted EBITDA, adjusted net income, and adjusted diluted EPS, you should be aware that in the future the Company may incur expenses similar to those eliminated in this presentation and this presentation should not be construed as an inference that future results will be unaffected by unusual items. CERTARA 2#3Agenda CEO Remarks Software: Innovating to Transform Traditional R&D Q&A Break Technology-driven Services: Customer Value Creation Q&A Financial Guidance Q&A 3 CERTARA#4-2% $330.80 NBC Al Nasdaq CMCSA 5.65% Nasdaq100 +2.77 $51.85 PEPSICO PEP Nasdaq100 planda ▲0.61% +0.97 $161.13 Nasdog AAPL 0.62% Nasdaq 100 -1.01 $163.75 ▼ Nandag CEO Remarks William Feehery, Ph.D. Chief Executive Officer SBUX 2.83% Nasdaq 100 +3.08 $111.74 CERTARAO amazon AMZN ▲ 0.13% Nasdaq 100 +4.49 $3,448.21 +694.93 Nasdaq CERTARAO Nasdog 34,7 PayPal PYPL Nasdaq 100 4.60% +8.25 $187.57 +75.08 4,588.12 SNBC CMCSA Nasdaq100 Nasdag 5.65% +2.77 $51.85 Too Far WeldT PayPal PYPL 4.60% Nasdaq 100 $187.5 +8.25 CERTARAO#5Certara at a glance BUSINESS 20+ Year History of innovation 1,100+ Employees(1) 350+ with Ph.D.s, Pharm.D.s and M.D.s 15 Acquisitions Track record of accretive, complementary acquisitions (1) As of 11/30/2021 (2) Market research reports from Grand View and SpendEdge (3) Customer data as of 12/31/2020 (4) See Appendix for reconciliation tables ● ● ● END-TO-END PLATFORM Software ● Biosimulation Regulatory & compliance Market access Technology-Driven Services • Drug discovery & development with biosimulation • Regulatory science Market access $13B TAM growing at 12-16% CAGR(²) CUSTOMERS (3) 1,650+ Customers across 61 countries 10+ Year Average tenure for top 30 customers 261 customers with ACV > $100,000 53 customers with ACV > $1M 2021 Q1-Q3 FINANCIALS $210.8M Revenue 18% YoY Growth $75.5M Adjusted EBITDA (4) 15% YoY Growth 36% Adjusted EBITDA Margin Net Loss ($3.6M) PY $5.1M 5 CERTARA#6Accelerating medicines using biosimulation and technology DISCOVERY NONCLINICAL CLINICAL POST Regulatory and compliance technologies APPROVAL Informing critical decisions throughout R&D using technology-driven services Biosimulation software Market access software CERTARA#7Advancing drug programs with our suite of solutions Biosimulation Increasing probability of success throughout R&D lifecycle Regulatory & Access Biosimulation is applied throughout R&D and integrated into regulatory strategy and submission Technology-driven regulatory science improves quality, delivers scalability and expedites the submission process Modeling and analytics help to understand and incorporate real-world impact in value assessment and market access decisions 7 CERTARA#8Predictive power of biosimulation Biosimulation uses computer-based models of biological systems to predict how the body affects the drug and how the drug affects the body. Simcyp Advanced Models for 10 Organs Skin Lung Liver Adipose Gut M Brain Heart Kidney Muscle Bone 8 CERTARA#9Streamlining trials and optimizing outcomes Biosimulation Use Case Examples Nonclinical Discovery Clinical Improve target selection Identify safety risks early Replace, reduce and refine animal studies Inform design of subsequent experiments Determine first-in-human dosing Waive drug interaction studies Optimize dosing for special populations Streamline or waive bioequivalence studies Benefits Fail faster Streamline or waive animal and human studies Help increase safety and efficacy Cut time and cost 9 CERTARA#10Differentiated strengths fuel global expansion 血 III Proprietary end-to-end software platform Biosimulation software adopted by 17 regulatory agencies Embedded in customers' R&D process with 90% renewal rate Scalable service model powered by technology and leading experts $M Revenue Nine Months by Region Ended Sept. 30 178.9 13.1 30.6 135.2 2020 44% 35% 11% Americas EMEA 10 210.8 18.9 41.2 150.6 2021 Asia Pac CERTARA#11Large, growing end markets 2022 $13B Ï Biosimulation $2.8B TAM 16% CAGR Regulatory $8.8B TAM 12% CAGR 2026 $21B 12% -16% ‒‒‒‒‒‒ Market Access $1.5B TAM 12% CAGR aft INDVINNE Orian 30 Market Drivers FDA U.S. Department of Health and Human Serib Food and Drug Administration Biotech growth OUTSOURCING Global regulatory support Outsourcing 11 CERTARA#12Drug R&D grows in complexity and cost Cost Small Molecules Peptides Cell & Gene Therapy Antibodies Complexity Cost of development grows with complexity of compound Clinical phase times are increasing Biologics comprise 43% of the R&D pipeline Complex generics also pose development challenges 12 CERTARA#13Powerful flywheel effect fuels momentum and adoption Regulatory / Industry Flywheel Effect Drug Approvals Industry Adoption Innovation Regulatory Guidances New technology and biosimulation models expand use cases 13 CERTARA#14Driving innovation - 10 new products and updates in 2021 Regular cadence of new software launches and new capabilities to expand use cases SimcypTM Simulator Versions 20 and 21 Synchrogenix™M Writer ● PINNACLE 21 Pinnacle 21™ Enterprise ● Immuno-oncology Immunogenicity Vaccine Simulator Quantitative Systems Pharmacology D360TM Platform Simcyp™ Secondary Intelligence BaseCaseTM Platform 14 Innovation CERTARA#15Powerful flywheel effect fuels momentum and adoption Regulatory / Industry Flywheel Effect Drug Approvals Industry Adoption Innovation Regulatory Guidances New technology and biosimulation models expand use cases Global regulatory guidances and workshops educate industry and advance use of biosimulation 15 CERTARA#16Increasing regulatory adoption 3 Incorporation of Biosimulation in FDA Guidances <2000 30+ FDA Guidances to Date PopPK Dose-response 5 Renal impairment Hepatic impairment 2000 - 2010 6 Pediatric HIV Animal QT interval prolongation 2011-2015 17 Pediatric rare diseases Drug-drug interaction PBPK Biosimilars Hypertension Ulcerative colitis Multi- regional clinical trials 2016-2020 MIDD applications in the report include: Predicting clinical outcomes Informing trial designs. ● ● 2021 FDA Focus Areas of Regulatory Science Model-informed product development aims to integrate information from diverse data sources to help decrease uncertainty and lower failure rates, and to develop information that cannot or would not be generated experimentally. Supporting evidence for efficacy Optimizing drug dosing Predicting product safety Drug Approvals https://www.fda.gov/science-research/advancing- regulatory-science/focus-areas-regulatory-science 16 Adoption Innovation Regulatory Guidances CERTARA#17Powerful flywheel effect fuels momentum and adoption Regulatory / Industry Flywheel Effect Biopharmaceutical companies use biosimulation and technology-driven services to accelerate R&D programs Drug Approvals Industry Adoption Innovation Regulatory Guidances New technology and biosimulation models expand use cases Global regulatory guidances and workshops educate industry and advance use of biosimulation 17 CERTARA#18Growing number of publications by industry and academia Number of Scientific Publications on Biosimulation ~2,000 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 PK Modeling PBPK 2014 2015 2016 2017 2018 2019 ~8,000 2020 2021 YTD The Journal of Official Publication of the American College of Clinical Pharmacology Population Pharmacokinetics of TAK-931, a Cell Division Cycle 7 Kinase Inhibitor, in Patients With Advanced Solid Tumors CPT: Pharmacometrics & Systems Pharmacology ARTICLE Open Access Ⓒ V²ACHER: Visualization of complex trial data in pharmacometric analyses with covariates ELSEVIER European Journal of Pharmaceutics and Biopharmaceutics Volume 164, July 2021, Pages 54-65 Pediatric formulation development - Challenges of today and strategies for Clinical Pharmacology Official Publication of the American College of Clinical Pharmacology Orig tomorrow: Summary report from M-CERSI workshop 2019 Industry Adoption 18 Innovation Regulatory Guidances Meta-Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure CERTARA#19Powerful flywheel effect fuels momentum and adoption Regulatory / Industry Flywheel Effect New drug approvals incorporating biosimulation serve as proof points and unlock more opportunities Biopharmaceutical companies use biosimulation and technology-driven services to accelerate R&D programs Drug Approvals Industry Adoption Innovation Regulatory Guidances New technology and biosimulation models expand use cases Global regulatory guidances and workshops educate industry and advance use of biosimulation 19 CERTARA#20Drug approvals using biosimulation Our customers, who use our software and technology-driven services, have received 90% of FDA drug approvals for 7 consecutive years.* FDA Novel Drug Approvals Received by Our Clients 2014 - 2020 Orphan designation Oncology Infectious disease Neurology Hematology Dermatology Cardiology Gastroenterology Pulmonary Diabetes Migraine Psychiatry Sleep disorders Bone Other 0 20 40 60 Number of Drug Approvals 80 *Excludes diagnostics Orphan designation applies across therapeutic areas 100 120 140 maribavir tepotinib ponesimod maralixibato atogepanta asciminib: sotorasib 2021 Novel Drug Approvals Using Certara Solutions brincidofovir casimersen Drug Approvals mobocertinib belumosudil belzutifan yoclosporin illustrative examples Industry Adoption 20 Innovation Regulatory Guidances CERTARA#21Disciplined, strategic approach to M&A Proven track record of successfully acquiring and integrating businesses Our strategy is highly disciplined and growth- and capability-focused. We continually seek and assess a range of opportunities in: Software and technology to build out the depth and breadth of our end-to-end platform Services to strengthen and scale our technology-driven services and accelerate global expansion We are uniquely well-positioned to be the acquirer of choice in the markets in which we compete. 21 CERTARA#22Diverse global team of leading experts C R A A 08 22 Ma SERTARA?#23Diverse global team of leading experts 1,100+ employees 24% growth in people YTD North America ~550 Europe 400 Asia Pac ~175 350+ with Ph.D.'s, Pharm.D.'s and M.D.'s 150+ scientific publications and presentations in 2021 7 of our scientists recognized as top 2% most cited 23 CERTARA?#24Proven growth strategy Innovation Technology leader with 90%+ renewal rate Land and Expand web Significant white space to expand with customers and add new ones M&A $ Global Expansion 15 successful strategic acquisitions, 10 with software People An employer of choice, attracting leading experts Track record of mid-teens topline growth with EBITDA margins in mid- to high-30s 24 CERTARA#25Our speakers today Andrew Schemick Chief Financial Officer Robert Aspbury President of Simcyp Leif Pedersen President of Software Justin Edge President of Regulatory and Access Patrick Smith President of Integrated Drug Development 25 Hannah Jones VP, Simcyp Consultancy CERTARA#26COMPANIES Leif Pedersen President of Software GROWING PRIVATE COMPANIES 520 Software: Innovating to Transform Traditional R&D 26 CERTARA#27Certara Software Year to date as of September 30, 2021 YoY change Revenue $61.3M 10% Bookings $62.2M 19% Renewal Rate 90% PY 91% 2021 Highlights 2 new software launches and 8 product updates Pinnacle 21 acquisition 2021 R&D 100 Award for COVID-19 Vaccine Model 27 CERTARAO#28Industry-leading software with more than 60,000 users Biosimulation P Phoenix Industry-leading software for PK/PD, toxico- kinetic, and non-compartmental analyses - required for regulatory submissions 36,000+ Google Scholar citations Integrated discovery informatics. software with self-service access and analytics D360 Used by 6,500+ discovery research scientists Simcyp Leading mechanistic biosimulation platform used to predict how drugs work, without human or animal studies Supported >250 label claims for 85+ drugs op. 55 proprietary databases and analytics to compare drug's safety and efficacy relative to competitors' CODEX Covers 10,000+ studies C Certara Integral Repository Regulatory & Market Access GlobalSubmit BaseCase PINNACLE 21 Enterprise Synchrogenix Writer Cloud-based applications to achieve regulatory compliance, prepare regulatory submissions and expand market access 40,000+ users 28 CERTARA#29Simcyp Platform Overview Robert Aspbury, Ph.D. President of Simcyp CERTARA Simoyp 29 CERTARA#30Simcyp platform spans discovery to post-approval support DISCOVERY NONCLINICAL CLINICAL Simcyp Mechanistic Biosimulation Platform POST APPROVAL 30 CERTARA#31Mechanistic biosimulation is used to quantitatively predict, without human or animal studies... What the body does to the drug Physiologically-based pharmacokinetics (PBPK) Simcyp Simulator Drug Ingestion Excretion Absorption Distribution Metabolism 31 CERTARA#32Mechanistic biosimulation is used to quantitatively predict, without human or animal studies... What you want the drug to do to the body Quantitative systems Pharmacology (QSP) Simcyp QSP What the body does to the drug Physiologically-based pharmacokinetics (PBPK) Simcyp Simulator Mechanism of Action Drug Activity Dose 32 CERTARA#33Mechanistic biosimulation is used to quantitatively predict, without human or animal studies... What you want the drug to do to the body Quantitative systems Pharmacology (QSP) Simcyp QSP What the body does to the drug Physiologically-based pharmacokinetics (PBPK) Simcyp Simulator What you don't want the drug to do to the body Quantitative systems toxicology and safety (QSTS) Secondary Intelligence Primary Target Off Target Interactions Secondary Effects Adapted from Jenkinson et al., 2020 33 CERTARA#34Simcyp Platform, leading mechanistic biosimulation software Built upon first principles of biology, chemistry and pharmacology օստաալ Neuro- degenerative Immuno- genicity Oncology COVID-19 Quantitative Pharmacology (QSP) ve Systems PBPK Simcyp Mechanistic Biosimulation Platform pharmacokinetics (PBPK) Cardiac Safety Physiologic Safety and Toxicity Pediatrics Quantitative Systems Toxicology & Safety Animal Mech DermA ● 18 of the top 20 biopharma companies by R&D spend used the Simcyp Platform in 2021 • Used by 11 global regulatory agencies Recipient of FDA cooperative R&D agreement, 6 FDA grants and 7 European grants Drives both software and tech-driven consulting ● Supported FDA approval of 85+ novel drugs with more than 250 label claims ● 34 CERTARA#35Growing regulatory adoption and support ● ● ● Recent FDA Guidances Guidance for Industry Pharmacokinetics in Patients with Impaired Renal Function Study Design, Data Analysis, and Impact on Dosing DRAFT GUIDANCE The Use of Physiologically Based Pharmacokinetic Analyses Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls Guidance for Industry Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry DRAFT GUIDANCE Japan Pharmaceuticals and Medical Devices Agency Population pharmacokinetic and pharmacodynamic analysis Exposure-response analysis of drugs Analysis reports involving physiologically based pharmacokinetic models Drug interaction for drug development and appropriate provision of information Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry DRAFT GUIDANCE ● ● ● ● ● ● ● ● European Medicines Agency Guidances Investigation of drug interactions Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products Evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function Role of pharmacokinetics in the development of medicinal products in the paediatric population Reporting the results of population pharmacokinetic analysis Reporting of physiologically based pharmacokinetic modeling and simulation China National Medical Products Agency PK/PD research of antimicrobials Extrapolation of adult medication data to pediatric populations Biostatical analysis in clinical trials Drug interaction Rare disease drug development 35 CERTARA#36Industry and academic adoption astellas ucb SANOFI Landbeck Eisai Mitsubishi Tanabe Pharma Ame Simcyp Consortium AstraZeneca Pfizer gsk ono MERCK L E O Biogen Otsuka SHIONOGI INC. Sumitomo Dainippon Pharma Incyte VERTEX NEKTAR GRUNENTHAL TAISHO PHARMACEUTICAL idorsia illustrative examples of consortium members Number of Simcyp Scientific Publications 16 Independent publications Simcyp publications 11 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 141 36 CERTARA#37Simulating virtual patients and waiving clinical studies More than 250 label claims for 85+ novel drugs using the Simcyp Simulator NEVIS 2 000 ONCOLOGY RARE DISEASE CENTRAL NERVOUS SYSTEM INFECTIOUS DISEASE GASTROENTEROLOGY CARDIOVASCULAR OTHER Agios Amgen Ariad Ariad (Takeda) AstraZeneca AstraZeneca AstraZeneca Beigene BluePrint Medicines Celgene Daiichi Sankyo Eisai EMD Serono AkaRx (Eisai) AstraZeneca Auriana Genentech Genentech AbbVie AbbVie Alkermes Alkermes Gilead GSK Janssen Merck AstraZeneca Helsinn Actelion (J & J) Tibsovo (ivosidenib) Blincyto (blinatumomab) Alunbrig (brigatinib) Iclusig (ponatinib) Calquence (acalabrutinib) Lynparza (olaparib) Tagrisso (osimertinib) Brukinsa (zanubrutinib) Ayvakit (avapritinib) Inrebic (fedratinib hydrochloride) Turalio (pexidartinib) Lenvima (lenvatinib) Tepmetko (tepotinib hydrochloride) AbbVie Galderma Doptelet (avatrombopag maleate) Koselugo (selumetinib) Lupkynis (voclosporin) Enspryng (satralizumab) Evrysdi (risdiplam) Rinvoq (upadacitinib) Qulipta (atogepant) Aristada (aripiprazole lauroxil) Lybalvi (olanzapine; samidorphan) Veklury (remdesivir) Dectova (zanamivir) Olysio (simeprevir) Pifeltro (doravirine) Movantik (naloxegol) Akynzeo (fosnetupitant/palonosetron) Opsumit (macitentan) Orilissa (elagolix) Aklief (trifarotene) Genentech Genentech Genentech Genentech Incyte Janssen Janssen Lilly Lilly Loxo Oncology Novartis Novartis Novartis Global Blood Therapeutics Intercept Kadman Merck Mirum Eisai GW Research Janssen Kyowa Kirin Merck Nabriva Novartis Shionogi Johnson & Johnson Alecensa (alectinib) Cotellic (cobimetinib) Polivy (polatuzumab vedotin-piiq) Rozlytrek (entrectinib) Pemazyre (pemigatinib) Balversa (erdafitinib) Erleada (apalutamide) Retevmo (selpercatinib) Verzenio (abemaciclib) Vitrakvi (larotrectinib) Farydak (panobinostat) Kisqali (ribociclib succinate) Scemblix (asciminib) Janssen Lilly Oxbryta (voxelotor) Ocaliva (obeticholic acid) Rezurock (belumosudil) Welireg (belzutifan) Livmarli (maralixiba) Dayvigo (lemborexant) Epidiolex (cannabidiol) Ponvory (ponesimod) Nourianz (istradefylline) Prevymis (letermovir) Xenleta (lefamulin acetate) Egaten (triclabendazole) Symproic (naldemedine) Xarelto (rivaroxaban) Invokana (canagliflozin) Olumiant (baricitinib) Novartis Novartis Novartis Novartis Novartis Pfizer Pfizer Pharmacyclics Sanofi Seattle Genetics Spectrum Takeda Verastem Novartis PTC Therapeutics Sanofi Genzyme Vertex Vertex Lilly Novartis UCB Tibotec VIIV VIIV Shire Pfizer Merck Odomzo (sonidegib) Piqray (alpelisib) Rydapt (midostaurin) Tabrecta (capmatinib) Zykadia (ceritinib) Bosulif (bosutinib) Lorbrena (lorlatinib) Imbruvica (ibrutinib) Jevtana (cabazitaxel) Tukysa (tucatinib) Beleodaq (tucatinib) Exkivity (mobocertinib) Copiktra (duvelisib) Isturisa (osilodrostat) Emflaza (deflazacort) Cerdelga (eliglustat tartrate) Symdeko (tezacaftor/ivacaftor) Trikafta (elexacaftor/ivacaftor/tezacaftor) Reyvow (lasmiditan succinate) Mayzent (siponimod fumaric acid) Briviact (brivaracetam) Edurant (rilpivirine) Cabenuva Kit (cabotegravir, rilpivirine) Vocabria (cabotegravir sodium) Motegrity (prucalopride) Revatio (sildenafil) Steglatro (ertugliflozin) 37 CERTARA#382021 novel drug approval using Simcyp Simulator Multi-discipline Review for voclosporin Center for Drug Evaluation and Research All simulations were performed using the PK/PD Profiles mode in the Simcyp® Simulator (Version 17 Certara, Sheffield, UK). A scheme of the PBPK simulation strategy is shown in Figure 21, which summarizes the studies used for model development and verification, and model applications in DDI predictions. Simcyp library files of ketoconazole, diltiazem, verapamil and nor- verapamil, fluconazole, fluvoxamine, cimetidine, rifampin MD, efavirenz, rosuvastatin and pravastatin were used for DDI simulations without any modification except that a P-gp Ki of 0.059 M was incorporated into the sim-ketoconazole 400 mg QD file and ketoconazole CL/F was reduced to 3.7 L/h (see comments in the Results section). Simulated concentration-time profiles of voclosporin following difference dosing scenarios in the absence or presence of moderate CYP3A4 inhibitor fluconazole 0.25 mg/kg BID Compared to the Control Blood Concentration (ng/mL) 140 120 100 80 60 40 20 50 Label for drug-drug interaction informed by Simcyp -DRUG INTERACTIONS- . Moderate CYP3A4 inhibitors: Reduce LUPKYNIS daily dosage to 15.8 mg in the morning and 7.9 mg in the evening. (2.5, 7.1, 12.3) . Strong and moderate CYP3A4 inducers: Avoid co-administration. (7.1, 12.3) + Certain P-gp substrates: Reduce dosage of certain P-gp substrates with a narrow therapeutic window when co-administered with LUPKYNIS. (7.2, 12.3) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf 100 Time (h) 150 38 200 CERTARA#393 areas of significant impact with Simcyp Simulator Clinical Trial Waivers Extrapolation to Special Populations Reduction in Study Patients 39 CERTARA#40Regulatory priority to increase access to generics Simcyp Simulator can advance development of complex generics Increasing Access to Generic Alternatives for Complex Drugs Importance to FDA FDA supports the development of generic versions of complex drug products because they represent nearly one-third of drug products currently used but have less generic competition than non-complex drugs. The presence of generic drugs on the market helps to ensure availability of quality medicines at a lower cost to the American public. Zhao, Generic Drug Research Public Workshop May 2017, MD, USA General PBPK Model Applications for Generic Products PPI - DDI Gl local concentration Dissolution Waiver of in vivo studies BE 2021 Advancing Regulatory Science at FDA Specific populations Locally acting product assessment Critical quality attribute In vivo alcohol dose dumping simulation Mechanism change risks Increasing trends in using PBPK models to support regulatory decision making in the realm of generic drug development FDA Milestone FDA Approval of Diclofenac Gel First complex generic approved using the Simcyp Simulator to establish virtual bioequivalence in lieu of a clinical trial, saving significant time and money. 7amneal 10000162-833- air Research Highlight THEO COMPAR Diclofenac Sodium Topical Gel, 1% Use the Dosing Card Attached Inside the Carton See Medication Guide and Patient Instructions Inside of Carton For Topical Use Only Rx only Diclofenac Sodium Topical Gel, 1% Use the Dosing Card Attached Inside the Carton See Medication Guide and Patient Instructions Inside of Carton For Topical Use Only Reply Net Wt 100 g Net Wt 100 g FDA Physiologically-based pharmacokinetic modeling supported approval of a locally acting drug based on an efficient alternative bioequivalence approach. 40 CERTARA#41Emerging technologies in biosimulation What you want the drug to do to the body Quantitative systems Pharmacology (QSP) Simcyp QSP What the body does to the drug Physiologically-based pharmacokinetics (PBPK) Simcyp Simulator What you don't want the drug to do to the body Quantitative systems toxicology and safety (QSTS) Secondary Intelligence 41 CERTARA#42Platform approach to quantitative systems pharmacology QSP combines computational modeling and experimental data to examine the relationships between a drug, the biological system and the disease process. • Monoclonal antibodies ● Immunogenicity Y ● Bi-specifics Complement system Neuro-immunity Immuno-oncology ● • Combination therapies • IL-2 TIGIT • CAR T-cell therapies ● Vaccines Increasing complexity • COVID vaccines • Respiratory ● syncytial vaccine Oncology vaccine Neurodegenerative diseases ● ● ● ● Alzheimer's Parkinson's Multiple sclerosis Schizophrenia ● Gene therapies ● XX AAV vector delivery Hemophilia Fabry disease • Gaucher disease 42 CERTARA#43Addressing safety issues consistently and earlier Secondary Intelligence CERTARA ToxStudio®: Secondary Intelligence™ (V1.0) Projects Project Compounds Receptors Compound Assessment Thresholds You are here: Projects / Compound Assessment Compound assessment for Compound A Compound Assessment Compound Comparison Focus Compound Receptor B2-adrenoceptor ENT 1 adenosine ACHE PDE 40 B1-adrenoceptor PDE 3A C1A-adrenoceptor 2A-adrenoceptor H 2 histamine SERT serotonin Compound A Compound B Compound C Compound D Compound E Compound F Compound G v1 Compound H Compound I Compound J ● ● ● Toxicology and safety pharmacology impact organ-specific drug exposure Biosimulation tools can simulate and predict safety issues More efficient and consistent than traditional method Reduction in animal use Relevant for adjacent industries 43 CERTARA#44Simcyp Simulator Demo Hannah Jones, Ph.D. Vice President of Simcyp Consultancy 44 CERTARA#45Simcyp Simulator framework with virtual patients 10 Advanced Mechanistic Organ Models Venous Blood Lung Liver Adipose Brain Heart Gut Kidney Muscle Skin Others Arterial Blood Simcyp Simulator Model Structure Population Data Compound Data Simcyp Model 45 Trial Design CERTARA#46Numerous applications across R&D lifecycle ● ● ● ● Discovery/Nonclinical Animal to human extrapolation Early formulation assessment Early drug interaction risk assessment First-in-human dose prediction ● ● Early Development First-in-human single/multiple dose exposure Drug-drug interactions. Absorption, food effect and formulation modelling ● ● ● Late Development Drug-drug interactions Pediatric and special populations Organ impairment modelling Label claims in lieu of clinical study "Learn and confirm" with continuous Model Refinement, Verification and Validation wi 46 CERTARA#47Ibrutinib case study using Simcyp Simulator Ibrutinib for the treatment of mantle cell lymphoma Source: American Chemical Society Simcyp Modelling Strategy Simcyp model developed in healthy adults using lab and clinical data Simcyp model verified using clinical data with strong CYP3A4 inhibitor & inducer Simulated DDI with moderate CYP3A4 inhibitors & inducers in cancer patients -> recommended dose adjustments 47 CERTARA#48Ibrutinib model predicted untested scenarios Ketoconazole Cmax (observed) AUC Ketoconazole Cmax (simulated) AUC Erythromycin Cmax AUC Diltiazem Fluvoxamine Efavirenz Cmax AUC Cmax AUC Cmax AUC Rifampin Cmax (simulated) AUC Cmax Rifampin (observed) AUC 0.01 I 0.07 0.08 0.06 0.08 Drug-Drug Interaction Scenarios Observed DDI Verification Prediction 0.1 I 0.38 0.38 2.2 2.0 1.0 Ratio with 95% confidence interval 7.5 86 5.0 5.5 10.0 31 27 21 30 100.0 The Simcyp Simulator accurately predicted observed drug interactions and was used to study new scenarios, avoiding several DDI studies. 48 CERTARA#49Ibrutinib model used to inform dose adjustments in label "The simulations of PBPK model provided a dose optimization strategy for combined use of ibrutinib with specific CYP3A inhibitors or inducers." - from the FDA label report, June 28, 2013 CYP3A modulators Inhibitors Inducers Goal Simulated ibrutinib exposure vs. that of 560 mg without inhibitor should be <2 fold Simulated ibrutinib exposure vs. that of 140 mg without inducer should be >1 CYP3A interaction mechanisms of co- medications Strong, reversible, minimal accumulation (e.g. ketoconazole) Strong, time-dependent (e.g. ritonavir) Moderate Moderate Strong Ibrutinib dosing Reduce to 140 mg and give 2 hours before inhibitor Do not use Reduce to140 mg No dose adjustment Do not use 49 CERTARA#50Track record of scientific and regulatory milestones First PBPK workshop to FDA First FDA approval with virtual bioequivalence for complex generic ● ● ● First FDA acceptance of Simcyp simulation in lieu of DDI trial Simcyp used to enable drug to come off FDA clinical safety hold Yesterday Drug-drug interaction model Pediatrics module Animal module Cardiac safety simulator ● ● ● Gene therapy regulatory submission with QSP Today COVID-19 Vaccine Model wins R&D 100 Award Virtual bioequivalence Vaccine simulator Immuno-oncology Immunogenicity ● Secondary pharmacology • Long-acting injectables ● • Gene therapy Neurodegenerative diseases Tomorrow ● 50 CERTARA#51Clinical development opportunity DISCOVERY NONCLINICAL CLINICAL POST APPROVAL 51 CERTARA#52Pain points in clinical phase significant opportunity Clinical Data Workflow 曲 CLINICAL STUDIES DATA STANDARDIZATION AND COMPLIANCE BIOSIMULATION AND DATA ANALYSIS REGULATORY CONTENT AND SUBMISSION 52 REGULATORY AGENCIES CERTARA#53Pain points in clinical phase significant opportunity Clinical Data Workflow CLINICAL DATA STANDARDIZATION STUDIES AND COMPLIANCE ● Growing number and diversity of data sources --> longer database lock cycle times • Lack of data governance Manual data management Customer Pain Points and Opportunities Sub-optimal trial design Patient recruitment challenges BIOSIMULATION AND DATA ANALYSIS ● • ~50% of compounds fail due to safety, efficacy or funding REGULATORY CONTENT AND SUBMISSION Get the dose right for the right patient ● Evolving regulatory and compliance landscape • Global regulatory filings 53 REGULATORY AGENCIES CERTARA#54Reducing errors, ensuring quality and increasing speed Clinical Data Workflow CLINICAL DATA STANDARDIZATION STUDIES AND COMPLIANCE PINNACLE 21 fo Integral Repository BIOSIMULATION AND DATA ANALYSIS REGULATORY CONTENT AND SUBMISSION 54 REGULATORY AGENCIES CERTARA#55Validating all clinical data submitted to FDA and PMDA Pinnacle 21 Enterprise Data Fitness Score 75 Actual Score Goal: 90 to 100 Earn points by fixing issues. +20 Reject +10 Error +5 Warning +5 Notice 1 issue 30 issues 100 issues 197 issues ● ● ● ● The US FDA and Japan's Pharmaceutical and Medical Devices Agency use Pinnacle 21 Enterprise to validate all clinical data submitted by sponsors 22 of the top 25 biopharmaceutical companies by R&D spend and 6 of the top 10 CRO's license Pinnacle 21 Enterprise Software integration with Integral Repository o CFR Part 11 compliant repository with audit trail Rollout of services powered by Pinnacle 21 Enterprise 55 CERTARA#56Mining insights to inform critical decisions Clinical Data Workflow CLINICAL STUDIES DATA STANDARDIZATION AND COMPLIANCE PINNACLE 21 & Integral Repository BIOSIMULATION AND DATA ANALYSIS P Phoenix Platform Simcyp Simulator REGULATORY CONTENT AND SUBMISSION 56 REGULATORY AGENCIES CERTARA#57Regulatory-adopted software for required analyses Phoenix PK/PD Software NLME IVIVC Toolkit WinNonlin P Integral Repository Validation Suites CDISC Tool ● ● ● ● Exposure-response information is at the heart of any determination of the safety and effectiveness of drugs. FDA Guidance for Industry, Exposure-Response Relationships, 2003 Leading software for non-compartmental analysis, pharmacokinetic/pharmacodynamic (PK/PD) and toxicokinetic modeling with 13,000+ users Multiple integrated modules for the full empirical biosimulation workflow with data processing, graphing and report generation Adopted by key regulatory agencies, including US FDA, Japan PMDA and China NMPA and used by 37 of the top 40 biopharma companies Customers can be confident they are using the same tools used by regulators to evaluate their products CERTARA 57#58Assuring and accelerating regulatory success Clinical Data Workflow CLINICAL STUDIES DATA STANDARDIZATION AND COMPLIANCE PINNACLE 21 & Integral Repository BIOSIMULATION AND DATA ANALYSIS P Phoenix Platform Simcyp Simulator REGULATORY CONTENT AND SUBMISSION 7 GlobalSubmit Software Synchrogenix Writer REGULATORY AGENCIES 58 CERTARA#59Next study is informed by biosimulation Clinical Data Workflow A CLINICAL STUDIES DATA STANDARDIZATION AND COMPLIANCE PINNACLE 21 & Integral Repository BIOSIMULATION AND DATA ANALYSIS P Phoenix Platform Simcyp Simulator REGULATORY CONTENT AND SUBMISSION 7 0-0- GlobalSubmit Software Synchrogenix Writer REGULATORY AGENCIES 59 CERTARA#60Use case from top 10 biopharmaceutical company Agnostic to operational model Request Data Frame Research Question Research Scientists Unlock clinical data to guide agile decision making in a click Simplified user experience for real-time data integration Adapted from client Data Ingestion Data Curator Easy data access Prepare Data VISION Content Validation Data Transformation Data Integration Structure Validation Data Medical Data Reviewer Conversion Expert Plug & play analytical tools to transform data into evidence Traceability for knowledge management Interoperability in context of Bedside to Bench & fast submission Analyse Consume Data Analytics & Insights Data Analyst External Disclosure & Internal Decisions Research Scientists Flexibility to explore data in a sandbox 60 CERTARA#61Technology-driven Services: Maximizing Client Value Creation C WIFI Justin Edge President of Regulatory & Access Patrick Smith, Pharm.D. President of Integrated Drug Development. 61 CERTARA#62Certara Technology-Driven Services Year to date as of September 30, 2021 YoY change Revenue $149.5M 22% Bookings $167.1M 10% NRR 115% PY 115% 2021 Highlights Advanced 1,200+ projects YTD Supported more than 250 regulatory submissions in past 4 years Grew global team of scientists and experts by 18% YTD 62 CERTARA#63Sustained drivers of our growth Biotech Investment • Healthcare investment in 1H 2021 reaches $47B Expanding biotech needs ● China growth ● Global Regulatory Tailwinds Parallel global filings EU Policy 70 Project Optimus Technology-driven Differentiation Technologies spanning entire life cycle to increase speed and quality Proprietary biosimulation tools 63 CERTARA#64Integrated suite of services powered by technology Full spectrum of technology-driven services from discovery and clinical development to regulatory and commercial success Drug Development and Regulatory Strategy CODEX Mechanistic Clinical Pharmacology and Pharmacometrics Phoenix Software Biosimulation Consulting Simcyp Simulator, QSP & Secondary Intelligence O O Regulatory Writing Synchrogenix Writer REQUIREMENTS E MATION LAW STANDARDS COMPLIANCE Regulatory Submissions GlobalSubmit, Pinnacle 21 64 Real World Evidence and Market Access BaseCase CERTARA#65Accelerating patient safety narratives with technology Patient safety narratives are critical to clinical study reports Summary of adverse events that occurred with a patient Required in all clinical phases across every therapeutic area ● ● Quality 3 Key Challenges in the Narrative Process C Speed Scale Synchrogenix Writer automates and accelerates the patient safety narrative process. Certara's regulatory team uses Synchrogenix Writer to generate quality narratives at speed and scale for many of our biopharmaceutical clients. 65 CERTARA#66CODEX for model-based meta-analysis (MBMA) CODEX Databases cover more than 55 therapeutic areas and 10,000+ studies Influences critical decisions in drug development Used by 9 out of the top 15 global biopharmaceutical companies ● Evidence Synthesis Public Data Optimize dose and dose regimen for a compund Optimize trial design Facilitate early go/no go decisions Perform portfolio profitization and due diligence in support of in/out licensing Show marketing viability and determine market strategy Proprietary Data 66 CERTARA#67Insights from the COVID-19 CODEX database Funded by the Bill and Melinda Gates Foundation, now includes 482 COVID-19 trials and real-world studies Comparison of RCTs and RWSS by COVID Treatment Overall Not randomized (n=112) Randomized (n=77) Anti-IL-6 Not randomized (n=38) Randomized (n=14) Antimalarial Not randomized (n=26) Randomized (n=24) Antiviral Not randomized (n=12) Randomized (n=19) Glucocorticoid Not randomized (n=28) Randomized (n=9) Plasma therapy Not randomized (n=13) Randomized (n=14) 0.250 0.500 Odds Ratio of Death 1.000 Real world studies (RWS) Randomized controlled trials (RCT) 2.000 ● ● ● ● ● Real world studies overestimated COVID treatment effects compared to randomized controlled trials Sheds important insights on how to bridge between real world studies and RCTs Valuable across all areas from rare diseases to viral pandemics CODEX can be used to create synthetic control arms Growing regulatory support for real-world evidence FDA U.S. FOOD & DRUG ADMINISTRATION FRAMEWORK FOR FDA'S REAL-WORLD EVIDENCE PROGRAM Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry 67 CERTARA#68Tale of two COVID-19 repurposed therapies Odds-ratio for death 3.0 2.5 2.0 1.5 1.0 0.5 0.0 200 Learning on Anti-Interleukin-6 (95% CI in green) 300 400 Pandemic Day 500 600 RWS RCT 14000 12000 10000 8000 cumulative sample size 6000 4000 2000 0 Odds-ratio for death 3.0 2.5 2.0 1.5 1.0 0.5 0.0 Learning on Glucocorticoids (critical/severe patients) T + 200 300 (95% CI in blue) 400 Pandemic Day 500 68 600 For new drugs to be commercially successful, they must differentiate themselves from the standard of care. Model-based meta-analysis using CODEX can help predict how a new drug's safety and efficacy profile might compare to competitor drugs, informing critical go/no-go decisions. RWS RCT CERTARA#69Different customer journeys depending on their needs Market Access Land and Expand Biosimulation Software Regulatory Science Biosimulation Services Lift and Shift Drug development & regulatory strategy Market Access Biosimulation Software Regulatory Science Biosimulation Services 69 CERTARA#70Practice areas with differentiated tools and support Global Health Pediatrics Complex Biologics Cell and Gene Therapy 70 CERTARA#71Advancing a novel, rare pediatric drug to FDA approval mirum Mirum, a start-up biotech, needed support to advance maralixibat, its novel therapy aimed at treating a rare pediatric disease, and chose to partner with Certara. ● ● ● Clinical pharmacology Clinical protocol design Regulatory strategy ● ● ● ● Non-compartmental PK analysis Phoenix Software Represent client at FDA meetings ● ● Drug interaction modeling Simcyp Simulator Regulatory submission Approved by the FDA as the first and only medication for the treatment of cholestatic pruritus in patients with Alagille syndrome 1 year of age and older • Client received a rare pediatric disease priority review voucher More than 35 scientists and regulatory experts at Certara contributed to this program FDA Approval 71 CERTARA#72Virtual drug development for a neglected, tropical disease Certara formed a virtual drug development team with Medicines Development for Global Health to work on moxidectin, a treatment for onchocerciasis or river blindness. River blindness is the second leading cause of infectious blindness, affecting at least 25 million people worldwide. ● ● Drug development and regulatory strategy Clinical pharmacology ● ● Population PK/PD analysis and NCA Clinical trial design ● ● Phoenix Software Epidemiology modeling FDA Approval Approved by the FDA as the first medication in 20 years to treat patients 12 and older Client received a tropical disease priority review voucher 72 CERTARA#73Meeting customers where they are Hong Kong-based biotech seeks FDA approval • Two cancer therapies in development Long-time Phoenix customer Simcyp and drug development consulting, regulatory writing and submission support, and HEOR modeling Client granted 2 FDA Fast Track designations ● ● Nasdaq-traded biotech needs major regulatory support Regulatory customer for 6 years Regulatory writing, including safety reports and narratives . NDA and BLA submissions with GlobalSubmit eCTD publishing Simcyp and drug development consulting Novel cancer drug approved by FDA in 2021 Top 3 pharma expands into evidence and access HS CI HN • 10+ year partnership with Simcyp, Phoenix, R&D consulting Expansion with evidence and access support across immunology, neuroscience & oncology programs o Health economics models, health technology assessments, payer insights, dossier, value messaging Successful coverage achieved in major and secondary EU markets 73 CERTARA#74People, passion and purpose Employer of choice in industry with 350+ experts with doctorate degrees Strong growth globally, especially in Europe and Asia Pac with nearly 30% growth in people YTD Sales and marketing expansion with more than 40% growth in people YTD ● ESSENT SLEEP VALIDATE REPEAT Welcome NUZIZ Best Places to Work NJ 2021 CONGRATULATIONS TO THE 2021 BEST PLACES TO WORK IN NEW JERSEVI EAT DRUM SON Breast CANCER 74 CERTARA#75Educating to influence Education and Certification ● ● ● ED CERTARA CERTIFIED Phoenix® WinNonlinⓇ NCA Analyst EI CERTARA BASECASE Developer 3,000+ scientists trained in 2021 48 scientific webinars in 2021 with 15,000+ attendees and recording views Academic fellowships, awards and grants Scientific Publications and Presentations nature The NEW ENGLAND JOURNAL MEDICINE Biochemical CPT: Pharmacometrics & Mapping the hid Systems Pharmacology ASCPT aaps DIA THE LANCET Public Health BJCP. British Journal of Clinical Pharmacology WILEY 150+ scientific publications and presentations at key industry conferences YTD ●●● ***** 000 RAPS ISPOR Improuing houtchoure decisions Recognition of our experts by industry organizations ● ● Regulatory Engagement COMPLEX GENERICS Generic Industry Challenges #1: Model-Integrated Evidence for Generic Drug Development Generic Drug User Fee Amendments of 2017 (GDUFA) Science and Research Initiatives: Request for Public Input on Fiscal Year (FY) 2022 Generic Drug Research Virtual Public Workshop June 23, 2021 Amin Rostami, PhD Professor of Systems Pharmacology University of Manchester Experts invited to speak at FDA, European Medicines Agency, UK Medicines and Healthcare Products Regulatory Agency FDA Workshops in 2021 o Model Informed Drug Development Approaches for Immunogenicity Assessments 75 o Generic Drug Science and Research Initiatives Public Workshop CERTARA#76Q G A 76 CERTARA#77Financial Update and Outlook Andrew Schemick Chief Financial Officer ARCA CERTARA#78Track record of strong performance Year to date as of September 30, 2021 Revenue $210.8M YoY Change 18% See Appendix for reconciliation tables Net Loss Adj. EBITDA $75.5M ($3.6M) PY $5.1M 15% Diluted EPS ($0.02) PY $0.04 78 Adjusted Diluted EPS $0.16 167% CERTARA#79Bookings growth drives strong visibility TTM Bookings (through October 31, 2021) $M 350 300 250 200 150 100 50 0 272.1 198.2 73.9 2020 Software 19% growth 16% growth Services 322.1 236.5 85.6 2021 79 CERTARA#80Acquisition of Pinnacle 21, a leader in data standardization software ● Closed acquisition on 10/1 for purchase price of $310M with approximately $250M in cash consideration and 2,239,717 shares of Certara restricted common stock Estimated 2021 pro forma revenue of $23-24M, contributing $6M in 4Q21 Accretive to revenue and adjusted EBITDA 57 employees and ~70% are software developers and data standards experts Pinnacle 21 Enterprise Software >130 customers, including 22 of top 25 leading biopharma companies Average annual customer subscription value >$100k in 2020 and growing 94% aggregate renewal rate in 2020 O Expecting 2022 Pinnacle 21 revenue of $28-31M and adjusted EBITDA of $12 - 13M (~43% EBITDA margin) 1.Internal estimate based off of commissioned market research We have not reconciled the adjusted EBITDA and adjusted EIBTDA margin above to the most directly comparable GAAP measures because this cannot be done without unreasonable effort due to the variability and low visibility with respect to costs related to acquisitions, financings, and employee stock compensation programs, which are potential adjustments to future earnings. We expect the variability of these items to have a potentially unpredictable, and a potentially significant, impact on our future GAAP financial results. $300M Total Addressable Market (1) for CDISC Compliance Software 12%-15% CAGR (2022-2026) 80 CERTARAO#81FASB final guidance no longer requires purchase accounting adjustment Subsequent to our third quarter earnings release, the FASB issued final guidance that requires companies to apply ASC 606 to recognize and measure contract assets and liabilities from contracts with customers acquired in a business combination. This creates an exception to the general recognition and measurement principle in ASC 805. As a result, companies will recognize contract assets and contract liabilities at amounts consistent with those recorded by the acquiree immediately before the acquisition date. The standard is effective for fiscal years beginning after December 15, 2022; however, Certara will early adopt the standard for fiscal year 2021. No deferred revenue valuation adjustment will be required, and Certara will not be providing guidance or report an Adjusted Revenue metric 81 CERTARA#822022 Outlook Certara Initiates 2022 Guidance Revenue $350-$370M 20-25% YoY growth Adjusted EBITDA (¹) $127-$135M 36-37% EBITDA Margin Adjusted Diluted EPS(1)(2) $0.48-$0.53 This financial guidance was provided as of December 15, 2021, and its inclusion in this presentation should not be construed as continued affirmation of such guidance beyond that date. (1) We have not reconciled the adjusted EBITDA and adjusted diluted EPS forward-looking guidance above to the most directly comparable GAAP measures because this cannot be done without unreasonable effort due to the variability and low visibility with respect to costs related to acquisitions, financings, and employee stock compensation programs, which are potential adjustments to future earnings. We expect the variability of these items to have a potentially unpredictable, and a potentially significant, impact on our future GAAP financial results. (2) The company is planning to revise the calculation of adjusted eps to exclude amortization expense related to M&A. Amortization related to P21 estimated based on preliminary purchase accounting valuation to be updated before year end. (3) Pinnacle21 Goodwill Amortization which will provide a cash tax benefit of approximately $500K per year Key Assumptions 2022 Guidance Revenue growth excluding Pinnacle 21 expected to be 12-17% Fully diluted shares expected to be in the range of 156-158M GAAP tax rate expected to be in the range of 40-45% Cash tax rate expected to be 20-25%(3) 82 CERTARAO#83yay DER 726156 BROADWAY REPRITE TOMORROW Nasdaq bi dedes Nasdaq REWRITE TOMORROW Nasdaq HULLE 68131 Concluding Remarks William Feehery Chief Executive Officer NEFT ABOY CERTARA DANI GOOD WHOLEH CH NGU POLICE 83 11 ALLF Miss CERTARA NEW Time Sare COLLE#84Full Certara toolkit to advance a drug program DISCOVERY Software • D360 • Simcyp QSP ● ● ● Technology-driven Services • Simcyp consulting ● NONCLINICAL Simcyp Simulator Phoenix Software Secondary Intelligence Drug development & regulatory strategy • IND submission ● • Toxicology ● ● ● ● ● CLINICAL ● Pinnacle 21 Integral CODEX • Clinical pharmacology • Pharmacometrics • Model-based meta-analysis GlobalSubmit eCTD Synchrogenix Writer Regulatory writing Regulatory submissions ● POST APPROVAL ● BaseCase Software Market access Real world evidence • Pharmacovigilance 84 CERTARA#85Certara investment highlights $ Attractive end markets growing in mid-teens driven by R&D efficiency demand and global adoption Technology leader with highly predictable business model with 90%+ renewal rates Deeply embedded scientific solutions at the core of R&D with 1,650+ customers Significant opportunities to expand within customer base and add new customers worldwide EX Long track record of growth and profitability with EBITDA margins in mid- to high- 30's and strong free cash flow Proven track record of innovation and 15 successful strategic acquisitions 85 CERTARA#86CERTARAO accelerating medicines Investor Day 2021#87Appendix 87 CERTARA#88Reconciliation of Net Income (Loss) to Adjusted EBITDA (in thousands) Net income (loss)(a) Interest expense(a) Interest income(a) (Benefit) provision for income taxes(a) Depreciation and amortization expense(a) Intangible asset amortization(a) Currency gain (loss) (a) Equity-based compensation expense(b) Acquisition-related expenses(<) Integration expense(d) Transaction related expenses(e) Severance expense(f) Reorganization expense(s) Loss on disposal of fixed assets(h) Executive recruiting expense First-year Sarbanes-Oxley implementation costs() Adjusted EBITDA Three Months Ended September 30, Nine Months Ended September 30, 2020 2021 2020 2021 (1,762) $ 3,289 (84) (1,631) 533 10,209 $ $ (545) 8,165 7,561 154 22 86 129 26,126 $ 1,227 $ 5,929 (12) 350 614 9,956 37 1,181 216 57 487 150 83 9 188 (3,567) $ 13,549 (255) 349 1,687 30,436 (189) 20,846 9,713 1,776 304 413 469 20,472 $ 75,531 $ 88 5,050 19,810 (36) 4,696 1,836 29,804 (190) 2,286 1,165 57 487 361 190 9 188 65,713 CERTARA#89Reconciliation of Net Income (Loss) to Adjusted Net Income (Loss) (in thousands) Net income (loss)(a) Currency gain (loss) (a) Equity-based compensation expense(b) Acquisition-related expenses(c) Integration expense(d) Transaction related expenses(e) Severance expense(f) Reorganization expense() Loss on disposal of fixed assets(h) Executive recruiting expense() First-year Sarbanes-Oxley implementation costs() Income tax expense impact of adjustments(k) Adjusted net income Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 $ $ (1,762) $ (545) 8,165 7,561 154 ।। 22 86 129 (3,036) 10,774 $ 1,227 $ 37 1,181 216 57 487 150 83 9 188 (335) 3,300 $ (3,567) $ (189) 20,846 9,713 1,776 304 413 469 (5,382) 24,383 89 5,050 (190) 2,286 1,165 57 487 361 190 9 188 (600) $ 9,003 CERTARA#90Reconciliation of Diluted Earnings Per Share to Adjusted Diluted Earnings Per Share Diluted earnings per share(a) Currency gain (loss) (a) Equity-based compensation expense(b) Acquisition-related expenses(c) Integration expense(d) Transaction related expenses(e) Severance expense(f) Reorganization expense() Loss on disposal of fixed assets(h) Executive recruiting expense First-year Sarbanes-Oxley implementation costs) Income tax expense impact of adjustments(k) Adjusted diluted earnings per share Diluted weighted average common shares outstanding Effect of potentially dilutive shares outstanding ( Adjusted diluted weighted average common shares outstanding Three Months Ended September 30, 2021 2020 $ $ (0.01) $ 0.05 0.05 ||||||| (0.02) 0.07 $ 0.01 $ 0.01 |||||||| Nine Months Ended September 30, 2021 2020 0.02 $ (0.02) $ 0.13 0.06 0.02 |||| (0.03) 0.16 $ 0.04 90 0.02 |||||||| 0.06 149,016,609 132,407,786 147,894,227 132,407,786 4,303,765 4,584,295 153,320,374 132,407,786 152,478,522 132,407,786 CERTARA#91Notes to Reconciliations (b) (c) (d) (1) (₁) (k) (0) Represents amounts as determined under GAAP. Represents expense related to equity-based compensation. Equity-based compensation has been, and will continue to be for the foreseeable future, a recurring expense in our business and an important part of our compensation strategy. Represents costs associated with mergers and acquisitions and any retention bonuses pursuant to the acquisitions. Represents integration costs related to post-acquisition integration activities. Represents costs associated with directly expensed costs from the secondary offerings and debt modification. Represents charges for severance provided to former executives and non-executives. Represents expense related to reorganization, including legal entity reorganization. Represents the gain/loss related to disposal of fixed assets. Represents recruiting and relocation expenses related to hiring senior executives. Represents the first year Sarbanes-Oxley costs for accounting and consulting fees related to the Company's preparation to comply with Section 404 of the Sarbanes-Oxley Act in 2021. Represents the income tax effect of the non-GAAP adjustments calculated using the applicable statutory rate by jurisdiction. Represents potentially dilutive shares that were excluded from the Company's GAAP diluted weighted average shares outstanding because the Company had a reported net loss and therefore including these shares would have been anti-dilutive. 91 CERTARA

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