Be 1 MARKETING PLATFORM. July 2018

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1 Be 1 MARKETING PLATFORM July 2018

2 Breakthrough Technology, unique in Stoma care colostomates in EU BE 1 AT A GLANCE! B. Braun Solutions provider for colostomates Strong IP 45 patents and drawings Acquisition in M Targeted sales after 3 years 3M Only on Be1 2

3 Be 1 EXECUTIVE SUMMARY With the purchase of an innovative disruptive new technology in 2014, B. Braun seized the opportunity to further develop the Flexima /Softima 3S sales by offering colostomates a new option enabling them to control their stools and gas evacuation while feeling continent on top of a clinically proven Safe, Secure and Simple system. Furthermore and taking into account the fact that B. Braun will be the unique provider of such a solution to accelerate its sales development, it has been decided to use this disruptive technology to gain additional market shares by converting patients using other appliances systems from one of the 3 major competitors (Coloplast, Convatec and Hollister-Dansac) in a second step. Having this breakthrough innovation in the B Braun portfolio will be also a great door opener and will help the company to create interest around the B Braun company and possibly take advantage of cross projects like colorectal surgery patient s pathway to increase sales at a group level. 3

4 SCOPE OF THE PROJECT From Concept to a Revolution EC marking Soft Launch in FRANCE Proposal Nov 2014 Jan 2018 June 2018 Proposal 2 Selection Proposal 3 Initial Discussion with Stimatix Fine-tuning & Optimization: 2 clinical studies Investment in machines Design validation Acquisition of technology compatible with Flexima /Softima 3S & competitors base plates (Coloplast + Convatec) No more bag 4

5 Be 1 MARKETING PLATFORM CONTENT 1 2 Market Technical Documentation 3 4 Promotional Documentation & Tools Sales Strategy 5

6 1 MARKET Global overview Ostomy market 2B +4-5% per year incl. accessories Market ( 270M +5-7%/year) Urostomates Ileostomates Colostomates (+2,6%) Global ostomy market represents 1 Million of patients among which 40% [ patients] can be estimated as permanent ostomates. Overall, we can estimate the number of permanent colostomates patients using either a 2-Piece system or a 1- Piece system to as it represents 60% of ostomates. [Source: Stimatix2nd_business_plan_compatible competition2.xlsx] 6

7 1 MARKET DATA & DYNAMICS Ostomates Enterostomates (80%) Urostomates (20%) + 7% (France B.Braun growth) Temporary (60%) Permanent (40%) Ileostomates (85%) Colostomates (15%) Ileostomates (60%) Colostomates (40%) + 14% (France B.Braun growth) The global colostomy bags market including 1- Piece & 2-Piece bags, was valued at USD million in 2011 and is expected to reach USD million in 2018 growing at a CAGR of 2.6% from 2012 to [Source: Transparency Market Research. Global Ostomy Drainage Bags Market 2012_2018]. 7

8 1 MARKET DATA & DYNAMICS Focus on left colostomates (Left) Colostomates Temporary Permanent 1-Piece 1-Piece By addressing unmet needs for permanent left colostomates, this breakthrough technology will be considered as an alternative or additional solution for patients using already: 2-Piece 2-Piece - Closed pouches (1-Piece and 2-Piece systems) - Irrigation options (Gravity or Electrical) Irrigation Irrigation It will also help growing the market share of B. Braun for colostomates as it will place us as a UNIQUE complete OFFER provider. 8

9 20% #of publications 1 MARKET DATA & DYNAMICS - Expectations NEEDS & VALUES CHANGE WITH TIME More literature about continence and body image improvement for ostomates but still unmet needs. 150 PubMed Ostomy continence of ostomates experience clinically significant psychological symptoms (major depression and anxiety disorders) post operatively. [ ] Stoma management contributes significantly to anxiety and is a major concern for patients. WHAT CAN B. BRAUN BRING AS AN EXPERT IN STOMA CARE? 9

10 1 MARKET DATA & DYNAMICS - Expectations First pain point for ostomates: lose faith! Why should ostomates lose control of their body? 10

11 1 MARKET DATA & DYNAMICS - Expectations 11

12 1 MARKET DATA & DYNAMICS - Expectations 12

13 1 MARKET DATA & DYNAMICS - Expectations 13

14 1 PROJECT s OBJECTIVES Get beyond Basics! Control Be able to control evacuation and feel continent Discretion Maintain activity and Quality of Life Comfort Safety Flexibility Reduced learning curve Ease of use No leakage No skin complication 14

15 episodes Focus on the customer journey holistic 1 PROJECT s OBJECTIVES Get beyond Basics! Lean back technology Process oriented Marketing Customer Experience innovation Therapeutic area! Not to miss option! Satisfaction management Touchpoint innovation convenience Result with customer delight 15

16 1 CURRENT OPTIONS FOR LEFT COLOSTOMATES Any other option??? Collection bags Irrigation 16

17 1 Vitala Continence Control Device Single-use system designed to release stool from a terminal colostomy Expandable reservoir Umbrella valve ensuring air to escape when high pressure Connecting ring enhancing security Microporous plug to control inflation and deflation and to prevent problems and leakage Cap made of a waterproof filter Integrated filter No device related safety issues, but the sponsor decided to stop the clinical study because of high leakage rates due to partial or complete disconnection of the device from the skin barrier during use. Product withdrawn from the market 17

18 1 PROJECT s OBJECTIVES Get beyond Basics! What s behind a brandname? BUT 18

19 1 PROJECT s OBJECTIVES Get beyond Basics! Impactful and different Naming process within the stoma care portfolio Be 1 Stands for: The B from B. BRAUN Be as To be Stands for: INTEGRITY restoration for the patient UNICITY of the solution FIRST continence system On the long term, the brandname could become a common noun (like Kleenex, Post-It ) 19

20 1 PROJECT s OBJECTIVES Get beyond Basics! 20

21 1 PROJECT s OBJECTIVES Get beyond Basics! An ambitious plan to build a whole family Step1 B. Braun Capsule Step2 Competitors Capsule Small diameter Large diameter Mio Click Natura Be 1 Clic Be 1 Nature 55 mm 65 mm 50 mm 60 mm 57 mm - Conform 2 Image Be 1 2 (for Europe) Be 1 Image (US/CA/Australia) 55 mm - 21

22 1 MARKET DATA & DYNAMICS Conversion funnel Aware Consider Convert Become loyal Advocate Make the checkout as easy and quick as possible. Interesting content Full information. Transparency. Competitors BP Close customer relationship. Trust. Social Media. 22

23 Be 1 MARKETING PLATFORM CONTENT 1 2 Market Technical Documentation 3 4 Promotional Documentation & Tools Sales Strategy 23

24 2 TECHNICAL DOCUMENTATION Product Description Be 1 is the First Capsule for colostomates featuring: A closed folded pouch with an integrated filter (A) A guiding tab with a safety button (B) A capsule cover (C) A degassing button (D) C A D Be 1 Capsules are compatible with: Flexima /Softima 3S flat base plates but Flexima /Softima 3S Be 1 flat base plates are recommended (see following slides) for an easiest handling. B 24

25 2 TECHNICAL DOCUMENTATION Product Description 25

26 2 TECHNICAL DOCUMENTATION Product Description 14mm vs 15mm 26

27 2 TECHNICAL DOCUMENTATION Product Description Use of Be 1 with and Difficult 27% Difficult 49% Ease of use Easy 73% Easy 51% Coupling Verification Bad 20% Good 80% Bad 71% Good 29% *40 participants 27

28 2 TECHNICAL DOCUMENTATION Product Description Use of Flexima /Softima 3S closed pouch with and Difficult 6% Difficult 31% Ease of use Easy 94% Easy 69% 12% 9% Coupling Verification N.S. 88% bad good 91% bad good *40 participants *40 participants 28

29 2 TECHNICAL DOCUMENTATION Product Description Range presentation capsules Be 1 Diameter 55mm Stoma diameter <30 mm Pack of 10 units Pack of 30 units Diameter 65mm Stoma diameter <40 mm Pack of 10 units Pack of 30 units Range presentation Flexima /Softima 3S Be 1 Diameter 55mm Stoma diameter <30 mm Diameter 65mm Stoma diameter <40 mm Pack of 5 units Pack of 10 units Pack of 5 units Pack of 10 units 29

30 2 Be 1 vs Vitala Capsule Be 1 Vitala [Convatec] Cost Similar to pouch X10 (Pouch) Continence 24/7 Partial, up to 12h/day Contra-indications None Regular bowel pattern Collection capacity Standard Small Bag shape Standard Flat Cylindrical Gas release Active + Passive Passive Need to evacuate Sensing Auto-deployment No No Interference with the body Flexible Rigid Pression before deployment <60mmHg >120mmHg 30

31 2 TECHNICAL DOCUMENTATION Technical Data Sheet 31

32 2 TECHNICAL DOCUMENTATION Article numbers Capsule Be 1 (Box of 30, box of 10) How to read the Be 1 range refs? FFTCPDD DD = Diameter XX XX mm Flexima /Softima 3S Be 1 (Box of 5, box of 10) FF = Family code 93 Flexima 3S 95 Coloplast 96 Convatec 97 Hollister P = Packaging 1 10 units, 3 30 units C = Colour code 0 Beige 1 Transparent T = Type of pouch 1 Closed pouches 2 Roll Up pouches 3 High Flow pouches 4 Urostomy pouches 5 Capsule 32

33 2 TECHNICAL DOCUMENTATION Packaging Box of 30 units Name of the product 55mm Diameter of the capsule 65mm Reference of the base plate to be used with the capsule cap 33

34 2 TECHNICAL DOCUMENTATION Packaging Box of 10 units 55mm 65mm 34

35 2 TECHNICAL DOCUMENTATION Labelling Inner vs outer packaging (x10) The 3 indicates the box belongs to a box of 30units. The 1 indicates the box belongs to a box of 10units. No reimbursement label on the pack. Internal code for picking in the logistics areas including latefit. 35

36 2 TECHNICAL DOCUMENTATION Packaging 30 units box 36

37 2 TECHNICAL DOCUMENTATION Packaging 10 units box 37

38 2 TECHNICAL DOCUMENTATION Packaging 2 units box Daily pack Communication support Neutral pack Fancy layout 38

39 2 TECHNICAL DOCUMENTATION IFU/Leaflet In the Flexima /Softima 3S Be 1 base plates boxes In the Be 1 capsules boxes (x10) 39

40 2 TECHNICAL DOCUMENTATION Technology Prof Schachtrupp s statements regarding the intra-abdominal pressure (lap) : Normal IAP is 5-7mm Hg Obese patients may have > 10 mm Hg An IAP of 12mmHg or higher is considered to be pathological and is called intra-abdominal hypertension (IAH) An IAP > 20 mm Hg together with organ dysfunction is called abdominal compartment syndrome, a highly lethal condition mostly encountered in intensive care medicine Gas evacuation Automatic Secured system for opening Manual 40

41 2 TECHNICAL DOCUMENTATION Clinical Data # 1 Pilot Study Between October 2015 & December 2016 in 10 centers in France 14 patients monitored. Proof of concept Improve the use of the gas release button Adjust the pressure to have a spontaneous detachment of the cap cover and avoid base plate detachment with high gas stools pressure 41

42 2 TECHNICAL DOCUMENTATION Safety Study # 2 Safety Study Safety Study conducted to evaluate the efficacy of the device used to assure continence in terms of stool collection and leakage prevention in 7 centers in France [30 patients] (June to November 2017). Primary endpoints: the type of capsule cap cover removal (manual or spontaneous) due to pressure feeling or an other reason than pressure feeling the level of leakage (leakage under the base plate or leakage between the base plate and the capsule cap or leakage through the gas release button). The primary efficacy outcome is the occurrence of the combination of manual capsule cap cover removal due to pressure feeling (or in link with stools or gas arrival) and no leakage. 42

43 2 TECHNICAL DOCUMENTATION Safety Study Inclusion criteria Age > 18yo Colostomy > 1month Stoma height < 10mm Flat base plate Patient able to change his appliance 2/3 1/3 63,7years 77% 23% Permanent 77% 23% Temporary 35 months 30 patients enrolled 472 capsules used 43

44 Results 2 TECHNICAL DOCUMENTATION Safety Study Type of capsule cover removal 404 capsules analyzed 75% Opening linked to arrival of gas or stools 59% Manual 41% Automatic opening opening Continence feeling validated! 44

45 Results 2 TECHNICAL DOCUMENTATION Safety Study Level of leakages 472 capsules Leakages? NO 85% YES 15% Similar to Flexima /Softima 3S! Safety validated! 45

46 Results 2 TECHNICAL DOCUMENTATION Safety Study 60 % good body image 70 % have a safety feeling 67 % comfortable 79 % no stomarelated noise 56 % willing to continue to use the Be 1 QoL: Non significant difference 46

47 Results 2 TECHNICAL DOCUMENTATION Safety Study Peristomal skin condition: unchanged Easy to handle 77% Easy opening of the pouch 80% Easy removal 90% Easy degassing button 33% 47

48 2 TECHNICAL DOCUMENTATION Safety Study Frequency of use in the future Daily 23% Never 44% Regularly 20% Daily = 2/day Regularly=3/week Sometimes=1/week Sometimes 13% 48

49 Be 1 MARKETING PLATFORM CONTENT 1 2 Market Technical Documentation 3 4 Promotional Documentation & Tools Sales Strategy 49

50 3 INSIGHT FOR VALUE (I4V) MESSAGING Continence The desire to achieve continence of the stoma remains a common cause among persons with an ostomy and those involved in their care. Continence must be redefined as the ability to gain some level of control or predictability of fecal elimination. Most patients with a colostomy would like to restore control of stool and flatus [ ] referred as colostomy continence 50

51 3 INSIGHT FOR VALUE (I4V) MESSAGING Continence Body image 50% of colostomates feel their body is out of their control within a 4-month period postop 1/3 patients avoid social and leisure activities 51

52 3 INSIGHT FOR VALUE (I4V) MESSAGING Continence Body image Formation of an ostomy will affect every aspect of the person s daily life, with new issues for the patient to overcome including: Uncontrolled evacuation Fear of odor Restricted leisure activity Issues with regard to privacy Impaired body image Uncontrollable noise (flatus) Restricted sexual activity Fear of soiling/embarrassment 52

53 3 INSIGHT FOR VALUE (I4V) MESSAGING Security Comfort Body image Painful or irritated peristomal skin and odor and noise from the appliance were the most commonly reported stoma-related difficulties. 53

54 3 INSIGHT FOR VALUE (I4V) MESSAGING Body image Problems associated with pouch use such as flatus, odor, noise and frequent pouch changes can often become stressful and embarrassing. 54

55 3 INSIGHT FOR VALUE (I4V) MESSAGING Continence Body image End colostomy surgery is an important life-changing event for patients. The main postoperative concerns [ ] can include incontinence, restriction in social life, change in body image, sexual problems and impaired self-esteem. 55

56 3 INSIGHT FOR VALUE (I4V) MESSAGING Body image Bryant RA, Hampton BG. Ostomies and continent diversions: nursing management St Louis: Mosby-Year book, 1992 (cited in The pursuit of colostomy ) Common concerns include bathing, clothing, management of the ostomy at work, during exercise, recreational activity, travel, management of the ostomy during sexual activity and disclosure issues 56

57 3 PRODUCT BROCHURE Our assets (Clinical results) Continence 75% of patients say they are able to control their continence for gas and stool emission FOCUS MUST HAVE Body image 79% of patients judge that Be 1 is quiet and prevents stomarelated noise 60% of patients consider they have good or very good body image while wearing Be 1 Safety 85% of Be 1 capsules without leakage on 472 capsules used Comfort 67% of patients find the Be 1 comfortable even patients who usually wear 1-Piece appliances 57

58 3 WHAT DO THEY SAY? Verbatim from Be 1 patients «Our intimate life is much better» 1-Piece permanent colostomate (and her husband) «I feel less sick with this system» 1-Piece permanent colostomate «Wonderful device, hard to go back to a pouch, now!» 1-Piece temporary colostomate «I feel much cleaner and safe with this product compared to my usual pouch» 2-Piece permanent colostomate «I can feel when gas/ stools are coming» 1-Piece permanent colostomate 58

59 3 PROMOTIONAL DOCUMENTATION - Brochure Key Visual Colostomates can have various profiles: they can be active or retired, Men or Women, Young or old Simply because you could be one of them Key visual to enable easy identification within a group of persons. 59

60 3 Content PROMOTIONAL DOCUMENTATION - Brochure 60

61 3 Content PROMOTIONAL DOCUMENTATION - Brochure INSIGHTS 61

62 3 Content PROMOTIONAL DOCUMENTATION - Brochure SOLUTION 62

63 3 Content PROMOTIONAL DOCUMENTATION - Brochure EVIDENCE 63

64 3 Content PROMOTIONAL DOCUMENTATION - Brochure SOLUTION 64

65 3 PROMOTIONAL DOCUMENTATION - Brochure Slogan: Empower your body control Feeling continent Control the stoma-related noise Improve your self-esteem and body image Front page as a Teaser, no product is shown as it enables the patient to keep their stoma secret! 65

66 3 PICTURES DATABASE - Product 66

67 3 PICTURES DATABASE - Product 3D rendering \\BBMF05\markint\Global_Com\CURRENT MARCOM 3 SBAs\010_Pictures\Stoma Care\Be 1\B1 renderings 67

68 3 PICTURES DATABASE - Personas Mindset transformation (Sadness => Hope => Solution!) 68

69 3 PICTURES DATABASE - Personas Mindset transformation (Sadness => Hope => Solution!) 69

70 3 PICTURES DATABASE - Personas Mindset transformation (Sadness => Hope => Solution!) 70

71 3 PICTURES DATABASE - Personas Mindset transformation (Sadness => Hope => Solution!) 71

72 3 PICTURES DATABASE - Personas Every one deserves it! 72

73 3 IFU VIDEO (Without stoma) Technologie v2.mp4 73

74 3 IFU VIDEO (3D rendering with stoma) French version (Flexima ) GB version (Flexima ) GB version (Softima ) 74

75 3 IFU VIDEO (With stoma) Shooting done on July

76 3 Testimonial VIDEO (With patient) 76

77 3 Testimonial VIDEO (With ETnurse) 77

78 Be 1 MARKETING PLATFORM CONTENT 1 2 Market Technical Documentation 3 4 Promotional Documentation & Tools Sales Strategy 78

79 4 STAKEHOLDERS in STOMA CARE Hospital market MoH Registration & Reimbursement Departments Community market User Decision maker Retailers Family, Relatives Hospital and Community market nurses association Scientific societies patients associations 79

80 4 BUYING CENTER ANALYSIS Registration & Reimbursement Departments MoH Payer, Gatekeeper patients associations Community market Hospital market Influencer Influencer Prescriber Payer Influencer Prescriber Hospital market User, Payer Retailers Payer,Influencer Community market Decision maker nurses association Influencer Community market Scientific societies Influencer Community market Hospital market Family, Relatives Influencer Community market 80

81 4 WHERE TO FOCUS? patients associations Scientific societies nurses association Influencer B2B B2C MoH Gatekeeper Decision Maker User Buyer B2C2B We need to convince the end-user (= patient)! Create the BUZZ! Retailers 81

82 4 MARKET SEGMENTATION Macro segmentation using the colostomates needs according to the Maslow s hierarchy into 4 main levels. Control Discretion Be able to control evacuation and feel continence. Maintain activity and Quality of Life Micro segmentation? 1P VS 2P No need as demonstrated by the second clinical study ACTIVITY Users can be active or retired TEMP VS PERM Patients can be permanent or temporary colostomates Comfort Flexibility, reduced learning curve, easy to use Patients looking for both satisfying safety and comfortable products (including ease of use and reduced learning curve). Security No leakage, no skin complications Patients looking for leakfree ostomy appliances with skin friendly adhesive solutions. 82

83 4 TARGETING End-User Profile Act as a normal consumer More & More Left Colostomate Have the choice between various options Active Digitally Connected Men (50%) Women (50%) - Age of patients vary between 18 and Etiology (heavy pathology: tumours, cancers ) - Temporary and permanent - Similar distribution between male and female 83

84 4 TARGETING New Ostomates Target group: New ostomates Enterostomy, colostomy patients Temporary and permanent patients Total potentially accessible market share = 20 % Temporary (60%) Enterostomates (80%) New ostomates (100%) Urostomates (20%) Permanent (40%) Ileostomates (85%) Colostomates (15%) Ileostomates (60%) Colostomates (40%) 1-Piece 2-Piece 1-Piece 2-Piece 1-Piece 2-Piece 1-Piece 2-Piece B. Braun B. Braun B. Braun B. Braun B. Braun B. Braun B. Braun B. Braun Competition Competition Competition Competition Competition Competition Competition Competition 84

85 4 TARGETING Existing Ostomates Target group: Existing ostomates Enterostomy, colostomy patients Temporary and permanent patients Total potentially accessible market share = 20 % Temporary (60%) Existing ostomates Enterostomates (80%) Urostomates (20%) Permanent (40%) Ileostomates (85%) Colostomates (15%) Ileostomates (60%) Colostomates (40%) 1-Piece 2-Piece 1-Piece 2-Piece 1-Piece 2-Piece 1-Piece 2-Piece B. Braun B. Braun B. Braun B. Braun B. Braun B. Braun B. Braun B. Braun Coloplast Coloplast Coloplast Coloplast Coloplast Coloplast Coloplast Coloplast Convatec Convatec Convatec Convatec Convatec Convatec Convatec Convatec 85

86 4 SALES STRATEGY - PRICING 86

87 4 SALES STRATEGY Success stories 87

88 4 PRODUCT POSITIONING Nespresso Vocabulary Community (Club) Innovation (lifecycle) Pricing Expertise Luxury Sales strategy (capture, accessories) 88

89 4 PRODUCT POSITIONING CibaVision TM Efficiency Fashion Lifestyle Aesthetic Body image Self esteem Discretion Accessory 89

90 4 PRODUCT POSITIONING Be 1 Efficiency Community (Club) Innovation (lifecycle) Lifestyle Fashion Aesthetic Vocabulary Pricing Expertise Self esteem Discretion Luxury Accessory Sales strategy (capture, accessories) 90

91 4 POSITIONING & SALES STRATEGY Be 1 Efficiency Self esteem Lifestyle Aesthetic Expertise Clinical studies + soft launch results Capture NEW patients with the Be 1 Invent a new vocabulary for Be 1 users Set an appropriate Pricing vs 3S Closed pouch for an increased perceived value Community (Club) propose a subscription (Create a group of Be 1 ambassadors) More than 40y of expertise in Stoma Care 91

92 4 MARKETING CAMPAIGN Umbrella Positioning statement for the Stoma Care SBA OSTOMY CARE The right to live free from fear. People with a stoma want to live their lives as normal individuals. B. Braun offers holistic strategies to accompany individual pathways. Longterm experience combined with innovation is paving the road for all those involved to guarantee comfort and security in the lives of people with a stoma. 92

93 4 MARKETING CAMPAIGN Concept 93

94 4 MARKETING CAMPAIGN Roadmap Work in progress with the agency within a global project to have a GLOBAL CAMPAIGN for STOMA CARE based on the Positioning Statement (using our I4V Messaging database for each patient pathway. As Be 1 belongs to the colostomates pathway, the project is to adapt the photo shooting we already have to reinforce the messagings based on the verbatim we received so far from the clinical study. By Q Videos of testimonials (Patient + ETnurse) By Q Digital and B2C supports will be adapted then and will have to be consistent with the Global OPM Digital Communication plan and the work currently being done on the patient pathway to set appropriate touchpoints for both patients and healthcare professionals. 98

95 Thank you for your attention! Questions? Diane Ganan Division OPM Stoma Care Global Product Manager Stoma Care Céline Lilloni, PhD Division OPM Stoma Care Head of Global Marketing 99

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