PAION Earnings Call 1 st Half of Dr. Wolfgang Söhngen, CEO Abdelghani Omari, CFO Conference Call 12 August 2015

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1 PAION Earnings Call 1 st Half of 2015 Dr. Wolfgang Söhngen, CEO Abdelghani Omari, CFO Conference Call 12 August 2015

2 Disclaimer It is important to note that this information contains forward-looking statements which are based on the currently held beliefs and assumptions of the management of PAION AG, which are expressed in good faith and, in its opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of PAION AG, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. Given these risks, uncertainties and other factors, recipients of this information are cautioned not to place undue reliance on these forward-looking statements. PAION AG disclaims any obligation to update these forward-looking statements to reflect future events or developments. This presentation constitutes neither an offer to sell nor a solicitation to buy any securities of PAION AG (the Securities ) in Germany, the United States of America, the United Kingdom or any other jurisdiction. Neither this presentation nor anything contained herein shall form the basis of, or be relied on in connection with, any offer or commitment whatsoever. The Securities have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the Securities Act ). The Securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act. 2

3 Agenda 1. Corporate overview 2. Financials 3. Remimazolam US Strategy EU Strategy Japan/Asia Strategy 4. Summary 3

4 Corporate overview 4

5 Corporate overview PAION AG is a specialty pharma company with a focus on anesthesia products Remimazolam, PAION s lead drug candidate, in Phase III development Six regional partnerships for Remimazolam in China, South Korea, Canada, Russia (CIS), Turkey and MENA region Headcount of 30 (incl. Mgmt Board), HQ in Aachen, Germany: PAION AG with subsidiaries in Cambridge (UK): PAION UK Ltd New Jersey (USA): PAION, Inc. ~ EUR 47 million cash and cash equivalents Sufficient funds for Phase III programs with Remimazolam in the U.S. and EU Supervisory Board Dr. Jörg Spiekerkötter (Chairman) Background: Former CFO, Organon, Schering AG Dr. Karin Dorrepaal Background: Former Schering AG Board Member John Dawson Background: CEO Oxford BioMedica Management Dr. Wolfgang Söhngen Title: CEO, Founder Dr. Mariola Söhngen Title: CMO, Founder Abdelghani Omari Title: CFO 5

6 Corporate overview Listed on Frankfurt Stock Exchange, Prime Standard (FSE: PA8) Market capitalization: EUR ~ 137m High liquidity (3-month period Xetra): ~ 11 million shares traded, ~ EUR 0.5 million average trading volume per day Stock Performance (price and volume in EUR, H1 2015) Shareprice (EUR) 3,1 2,9 2,7 2,5 2,3 2,1 1,9 1,7 Trading Volume Xetra + Frankfurt (Share/day) Market Data (EUR in million except per share data) Capitalization Financial Data Current Share Price Revenue 3.5 FD Shares Outstanding EPS Market Cap (H1) Cash 47 Mean target price of 3 analyst reports (Edison, Oddo Seydler, First Berlin) ,

7 Financials 7

8 Consolidated statement of comprehensive income In accordance with IFRS (all figures in EUR k if not otherwise noted) Revenues R&D Costs H H H H SG&A Costs H H Net Result H H No significant revenues in H1 2015, revenues in prior-year period mainly related to Remimazolam license agreements Costs as planned higher than in H due to preparation, initiation and conduct of Phase III programs with Remimazolam in the U.S. and EU 8

9 Balance sheet and employees In accordance with IFRS (all figures in EUR k if not otherwise noted) Total assets Cash and cash equivalents Dec June Dec Total Cash Flow 30 June 2015 Equity Employees in the Group Dec June 2015 FY 2014 H Equity ratio as of 30 June 2015 was 91.5 % 9

10 Financial Outlook 2015 Actual FY 2014 EUR million Plan FY 2015 EUR million Comments Revenues 3.5 m < 50 k Costs R&D 11.8 m 25 m 30 m SG&A 3.7 m approx. 5.5 m Tax credits 2.4 m 5.0 m 6.0 m No significant revenues expected in 2015 due to concentration on development of Remimazolam Increased R&D expenses due to development of Remimazolam SG&A costs will increase, mainly due to higher selling expenses Tax credits on parts of R&D expenses from British tax authorities Net result -9.1 m m m Net loss will significantly increase Cash is sufficient for conducting the clinical Phase III programs Further funds of approx. EUR 10 million required up to approval for establishment of supply chain, securing preproduction of market material for launch phase and compiling the filing dossier for Japan 10

11 Pipeline overview Status of Development Compound Indication PC Ph I Ph II Ph III Estimated peak sales (worldwide pa) Partners Remimazolam i.v. anesthetic/ sedative General Anesthesia General Anesthesia Procedural Sedation Japan PAION PAION 500m US$ 500m US$ Yichang Humanwell (China) R-Pharm (Russia+CIS, Turkey, MENA) Hana Pharm (S Korea) Pendopharm (Canada) ICU Sedation Japan 500m US$ GGF2 i.v. glial growth factor Heart Failure Acorda (worldwide) M6G i.v. opioid Peri-operative Pain No Development Activities Yichang Humanwell (China) 11

12 Events in 2015 Start of first U.S. Phase III trial of Remimazolam for procedural sedation during colonoscopy Start of second U.S. Phase III trial of Remimazolam for procedural sedation during bronchoscopy Remimazolam know-how and tech transfer from Ono completed Start of EU Phase III trial of Remimazolam for general anesthesia March May June July August David Bernstein M.D. joins PAION as medical advisor Leave of Dr. Mariola Söhngen at the end of October 2015 announced Tim Morris joins PAION as non-executive Director 12

13 Remimazolam 13

14 PAION s lead product Remimazolam Product Ultra short-acting anesthetic/ sedative Providing fast onset of sedation and rapid recovery period Trials ~ 1,000 volunteers/ patients have had the product administered in trials Current focus is conducting phase III trials Market Market exclusivity expected until at least 2027 Attractive peak sales potential of ~US$ 500m worldwide per year in each indication 14

15 Product features of Remimazolam Propofol Remimazolam Midazolam CV/Respiratory depression No reversal agent Pain on injection Rapid onset/offset Predictable recovery time Less resources for supervision (after procedure) Lower safety issues Reversal agent Less resources for supervision (during procedure) Variable and prolonged periods of sedation Re-sedation risk Slow onset 15

16 Remimazolam Clinical development Completed Studies with ~ 1,000 volunteers/patients on drug Ongoing/Planned Studies with further ~ 1,000 patients Procedural Sedation General Anesthesia Procedural Sedation General Anesthesia 4 Phase I/II trials in the U.S. 5 Phase I/II trials in Japan (Ono) Phase III program in the U.S. Phase III program in the EU 2 Phase III trials in Japan (Ono) 1 Hepatic impairment study in the U.S. (Ono) 1 Phase II trial in Germany Phase III in colonoscopy started in March 2015 Phase III in bronchoscopy started in June 2015 Phase I studies ongoing ASA III/IV patients (planned) Phase III in cardiac surgery patients started in August

17 Remimazolam U.S. Strategy 17

18 Market Opportunity: Primary focus Colonoscopy Rapidly growing market, big push for colorectal cancer screening: Colonoscopy = the only diagnostic proven to prevent cancer Regular and appropriate colorectal cancer screening is both recommended and covered by all major health plans including CMS More than 4 million patients turn 50 and are newly eligible each year, baby boomers are all of age for screening, i.e. > 50 years There will be 48 million more covered lives in the U.S. as a result of the Affordable Care Act U.S. Market Size Total U.S. market for procedural sedation = 33 million procedures National Health Statistics Report Number 11 Jan. 28, 2009 revised; procedure estimates from the NSAS National Survey of Ambulatory Surgery 20 million procedures were performed outside of hospitals and represent the most attractive segment for PAION 29 million unique procedure claims for colonoscopy and endoscopy in 2013 Colonoscopy/endoscopy procedures updated with 2013 CPT, ICD9, HCPCS procedure code data from Symphony Health Solutions. 18

19 Colonoscopy Market in the U.S. is split into 2 main segments ~20 million GI Procedures per year outside of hospitals Providers using midazolam (65-70 %): Dominant in West, Midwest and South No anesthesiologist required Slower patient recovery to alert Less procedures due to slower throughput for clinician Lower cost for Insurers and CMS Problem: Less revenue for providers Providers using Propofol (30-35 %): Dominant in Northeast & Eastern U.S. Must use anesthesiologist Rapid patient recovery to alert More procedures for clinician as a result of faster throughput More revenue for providers Problem: Higher cost for insurers and CMS Each market has a different problem, Remimazolam offers solutions for both Midazolam users: Increased efficiency, throughput, and revenues for the provider and insurer Improved patient experience Propofol users: PAION assumes that anesthesiologists want to use Remimazolam instead of propofol Alternative sedation option allowing providers to maintain high throughput An alternative for patients with certain complicating risk factors 19

20 Midazolam = million patients in Conscious Sedation Remimazolam offers many potential advantages Both are: Similarities In the benzodiazepine family Administered intravenously Do/will not require anesthesiology assistance (anticipated) Remimazolam Advantages Mechanistic advantage Metabolism by tissue esterase Inactive metabolite Shorter half life Fast on Fast off Potential impact No re-sedation Earlier patient discharges Clinic efficiency Higher patient turnover/throughput (more procedures) Improved patient experience 20

21 Additional reasons to believe in Remimazolam Requires minimal behavioral changes for current midazolam users Low reimbursement uncertainty or formulary risks No competitive response/no counter detailing No new entries/competitors coming to market One product in Phase 1 development 21

22 U.S. Phase IIb data support business case vs. midazolam With an average reduction of 5 min/procedure and an average number of procedures of 10-20/day/doctor centres gain procedures/doctor per day if they switch from midazolam to Remimazolam Time to start procedure after initial dose Min Remimazolam - 5.0/3.0 mg 2.65 (1.42) Midazolam - 2.5/1.0 mg 4.80 (3.19) Time to be ready for discharge after last dose Min Remimazolam - 5.0/3.0 mg 11.3 (4.86) Midazolam - 2.5/1.0 mg 15.3 (8.13) 22

23 Current reimbursement levels make products very attractive that can allow for additional procedures Colonoscopy and anesthesia reimbursement level may vary significantly depending on commercial MCO * type. Reimbursements paid by a given commercial MCO may vary significantly, as payers look to negotiate rates and contract for provider services. Future Bundle Payer Type CPT Colonoscopy Reimbursement In-patient Out-patient CPT 0080/00740 Anesthesiology Reimbursement Medicare $466 $836 $158 Commercial HMO ** Commercial (Non-HMO) $326 - $373 $585 - $669 $110 - $126 $560 - $699 $1,003 - $1,254 $189 - $236 Sources: accessed 05/11/2015. Campbell Alliance preliminary primary research interviews (n=3) conducted with one GI, one anesthesiologist and one CRNA. *Managed care organization, **Health maintenance organization Note: Reimbursement values shown are estimated national averages. Medicare national average was determined from the state reimbursement levels shown previously and the distribution in medicare patient share (see appendix). 23

24 Remimazolam U.S. program conscious sedation Pivotal Studies Colonoscopy: Remimazolam (n=300) vs placebo (n=60) and midazolam (n=100) Started in March 2015 Completion expected end 2015/beginning 2016 Bronchoscopy: Remimazolam (n=300) vs. placebo (n = 60) and midazolam (n = 100) Started in June Completion expected in 2016 Safety Studies Phase III: Colonoscopy ASA III/IV patients (Remimazolam n = 30 vs midazolam n = 30 vs placebo n = 15) Phase I Studies ongoing Thorough QT Study, Renal Impairment, Abuse Liability Pediatric Study After filing Pediatric Plan agreed with FDA Labelling comparable to midazolam primary goal Midazolam labelling does not require an anesthesiologist to provide conscious sedation Filing scheduled in

25 U.S. business case non-hospital Conscious Sedation Highly attractive NPV PAION is exploring both a going-alone and a partnering strategy as well as a combination of both Significant Upside: Use in numerous other out-patients conscious sedation settings Additional Indications General Anesthesia ICU Sedation Pediatric Building a solid basis for a go-it-alone in all indications Attractive asset for Specialty Pharma with hospital focus as an alternative 25

26 Remimazolam EU Strategy 26

27 EU General Anesthesia - room for improvement Little innovation in anesthetic drug development in recent years Complication rates associated with GA/surgery are increasing due to increasing age of patients Low awareness concerning post-operative complications & mortality related to intra-operative hypotension events Intra-operative hypotension is a strong predictor of myocardial necrosis leading to higher 1 year postsurgical mortality (1-4) Even short durations of intra-operative hypotension are associated with acute kidney failure, myocardial injury, cardiac complications and 30 day mortality (4) Remimazolam has a significantly lower incidence of hypotension in surgical patients undergoing general anesthesia compared to propofol (5) The connection between intra-operative hypotension and post-operative cognitive dysfunction is not widely recognized These under-recognized issues, combined with an ageing population with increasing levels of co-morbidity, represent an opportunity for PAION & Remimazolam to impact patient care and outcomes in GA 1.Brady _Anesth_2013_119_495-7, 2.Bjiker_Anesthesiology_2009; 111: , 3. Monk_Anesth Analg 2005; 100:4 10, 4. Walsh_Anesth_2013_119_507-15, 5. ONO study report _Data on file, 27

28 Remimazolam safety data Remimazolam with or w/o opioids has less negative effect on blood pressure compared to propofol at the same level of sedation Remimazolam or Propofol (mg/kg) >= ED50 LRR ED20 BP >= Remimazolam Remimazolam Remimazolam Propofol Propofol Propofol Separation Hypotension/Sedation (ED20 BP / ED50 LRR) >= Rem. Prop. Remimazolam Propofol Rem. Prop. >= Rem. Prop. alone + fentanyl + remifentanil alone + fentanyl + remifentanil Source: PAION data on file 28

29 Phase II and Phase III studies in General Anesthesia with high success rate & excellent cardiostability Ono Phase III Study confirms efficacy and safety of Remimazolam compared to propofol Multicenter, randomized, parallel-group study in 375 patients undergoing surgery requiring general anesthesia Remimazolam showed a success rate of 100 %, met all endpoints and has a clinically meaningful lower cardio depressive effect compared to standard treatment (e. g. propofol) No adverse events of concern were observed Excellent safety profile of Remimazolam confirmed PAION Phase II Study confirms efficacy and safety of Remimazolam compared to propofol/sevoflurane Randomized, parallel-group study in 90 patients undergoing cardiac surgery using a heart-lung machine Remimazolam showed a success rate of 98 % and confirmed excellent cardiovascular stability Good safety profile of Remimazolam confirmed Clinically meaningful differentiation by reduced use of norepinephrine (36.7 %) as an indicator for cardiodepressive effects compared to propofol/sevoflurane Summary 29

30 Remimazolam is safe and effective in patients undergoing cardiac and general surgery with less hypotension and need for catecholamine use Summary Catecholamine use has a strong correlation with longer length of ICU stay Catecholamine usage during surgery is a predictor for potential negative outcomes: myocardial infarction, stroke, kidney injury and increased 30-day and 1 year-mortality Outcome of the Ono Phase III and PAION Phase II studies in general anesthesia: The need for first line vasopressor was statistically significantly lower with Remimazolam compared to propofol/sevoflurane The proportion of patients experiencing intraoperative hypotensive adverse events (during general anesthesia) and needing vasopressors or other treatment was lower with Remimazolam compared to propofol Remimazolam reduces concomitant use of catecholamines both in general surgery and cardiac surgery compared to propofol and to propofol/sevoflurane 30

31 Europe - launch indication targets hospital general surgical anesthesia, representing 28.6 million patients/year In-Patient Out-Patient Remimazolam ICU sedation Surgical general anesthesia Hospital procedural sedation Procedural sedation 31

32 Europe*: Remimazolam s launch target population 14 million high risk patients Remimazolam 70.4 m 32.2 m 28.6 m 14 m Surgical procedures in hospital + ambulatory All anesthesias General anesthesias Patient potential * Modeled data combining 2010 and 2012 national and regional statistics 32

33 Remimazolam EU program EU Phase III Anesthesia Randomized, prospective, propofol controlled multi-center study in anesthesia In adult patients during cardiac surgery Countries: Switzerland, Germany, France, Belgium, Poland Patient recruitment: n = 530 (n = 424 on Remimazolam and n = 106 on propofol) Started in August 2015 Completion expected in 2016 End points: Primary endpoint: Efficacy Secondary endpoint: Tolerability (hemodynamic stability) Filing scheduled in

34 Remimazolam Strategy Japan / Asia 34

35 Remimazolam Japan Remimazolam rights for Japan returned from Ono to PAION in July 2015 Know-how transfer (ONO -> PAION) completed Data from 6 clinical trials and preclinical studies will now be integrated into PAION s database Phase I bolus in healthy volunteers (Japan) Phase I infusion in healthy volunteers (Japan) Phase II induction and maintenance of anesthesia in general surgery (Japan) Phase II/III in surgical patients (Japan) Phase III in ASA III or higher surgical patients (Japan) Hepatic impairment study (USA) PAION has been contacted by parties interested in Japan Partnering process for a Remimazolam license for Japan ongoing KOLs confirmed that Remimazolam is regarded a needed innovation for the Japanese anesthesia market PMDA: PAION can directly apply for a Pre-NDA meeting CMC meeting with PMDA in second half of 2015 to discuss framework of the future production Pre-NDA meeting is expected to take place in the beginning of 2016 Japanese CRO is preparing the draft dossier that is required for this Pre-NDA meeting 35

36 Summary 36

37 Outlook 2015 and strategy Remimazolam Conduct Phase III programs in the U.S. and EU Pre-marketing and market access activities for Remimazolam Validation of manufacturing process at market scale Establishment of supply chain, stock piling and Japan activities EUR 10 million expected over the next 2 3 years Partnering and commercialization: EU and U.S.: Evaluation of partnering and independent commercialization strategies Japan: Alternative filing strategy under evaluation and decision about future manufacturing for Japan All other regions: Continuation of development activities by cooperation partners (Yichang Humanwell, Pendopharm, Hana Pharm, R-Pharm, TR-Pharm) New cooperations with license or distribution partners 37

38 Investment Highlights Lead product Remimazolam will potentially provide benefits over current standards of care Remimazolam has the potential to be an efficient alternative to existing products Addresses growing markets in procedural sedation and general anesthesia Currently undergoing Phase III trials in the U.S. and EU - late stage product with short time to headline data Numerous partnerships with regional anesthesia specialist partners have validated the product value Remimazolam has the potential in three indications + further potential in pediatric use 38

39 PAIONEERS GO WEST Our Vision To be the accepted PAIONeer in sedation and anesthesia in the U.S., the EU and beyond via our own commercial activities and successful partnerships 39

40 Thank you very much for your attention! Contact: PAION AG Martinstrasse Aachen Germany Phone

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