aim italia conference 2018 - kolinpharma 2019. 5. 30. · over the years 2013-2016 the nutraceutical...
TRANSCRIPT
AIM Italia Conference 2018Borsa Italiana – May 28th, 2018
Disclaimer
This document was prepared by KOLINPHARMA S.p.A. (the “Company”) exclusively for the purpose of this Roadshow Presentation and in relation to the admission to trading of the Company’ shares (the “Shares”) on the multilateral trading system AIMItalia / Mercato Alternativo del Capitale, organized and managed by Borsa Italiana S.p.A.
This document is not drafted for advertising purposes and it is neither an offer nor an invitation to purchase and/or subscribe the Shares nor it, or part of it, shall be deemed as the reason for or the ground of the execution of contracts, undertaking ofobligations or whatsoever investment decisions. The Company has neither drafted nor it will draft any prospectus for the placement of Shares among Italian professional investors and foreign institutional investors (the “Private Placement”). Anydecision to purchase or to subscribe the financial instruments relating to the Private Placement shall be taken independently from this presentation.
This presentation is not to be deemed as a recommendation for the purchase or subscription of financial instruments that are the object of the Private Placement and it was drafted exclusively for the purpose of the Private Placement of the Shares bythe Company. The information contained in this document were not verified by an independent body and no direct or indirect representation and warranty was granted in this respect by the Company, no reliance on the correctness, accurateness,completeness and exactness of such information is allowed.
The Company or its affiliates, consultants and representatives shall not be liable (for negligence or for other grounds) for damages arising out from this document or its content or, in any case, arising out from this document.
THIS PRESENTATION IS ADDRESSED EXCLUSIVELY TO QUALIFIED INVESTORS IN ITALY PURSUANT TO ARTICLE 34-TER, PARAGRAPH 1, LETTER B) OF ISSUERS’ REGULATION NO. 11971 DATED 14 MAY 1999 AS SUBSEQUENTLY AMENDED AND TO SOMEOTHER ENTITIES HAVING THEIR RESIDENCE IN OTHER STATES OF THE EUROPEAN ECONOMIC AREA (“EEA”) OTHERS THAN ITALY (IN WHICH STATE THE REGULATION MENTIONED ABOVE AND THE RELEVANT REQUIREMENTS DO APPLY) THAT AREDEFINED AS “QUALIFIED INVESTORS” PURSUANT TO ARTICLE 2(1)(E) OF THE SO CALLED PROSPECTUS DIRECTIVE NO. 2003/71/CE. THE INSTITUTIONAL OFFER OF THE COMPANY’S SHARES SHALL BE CARRIED OUT IN THE CONTEXT OF THE ADMISSION OFTHE COMPANY’S SHARES TO TRADING ON AIM ITALIA AND IT IS A CONDITION PRECEDENT OF SUCH AN ADMISSION. THIS DOCUMENT IS NOT ADDRESSED TO THE PUBLIC IN ITALY OR ABROAD. NO PUBLIC OFFER SHALL TAKE PLACE IN ITALY AND ABROAD.
This presentation may not be disseminated and it is not an offer to purchase financial instruments in United States, Canada, Australia, Japan and/or in any other jurisdiction in which such dissemination is not allowed. Neither this presentation nor anyof its copies may be distributed or disseminated directly and indirectly in the United States of America or to US citizens. The breach of such restrictions could be a breach of the applicable laws in matter of financial instruments in the United States ofAmerica. The Shares that are object of the Private Placement by the Company neither are nor will be registered according to Regulation S set forth by United States Securities Act of 1933; they will not be registered with any authority of financialregulation of any kind belonging to United States of America and they will not be offered or sold in the United States of America in the absence of the requirements set forth by Securities Act or by other applicable laws. The Company will neither carryout the placing of Shares, in total or in part, in the United States of America nor will carry out a public offer of financial instruments in the United States of America.
This document and its content are confidential and were prepared exclusively for information purpose and they cannot be copied, recorded, transmitted, disseminated to other persons or published, in whole or in part, through any means or form orfor any other purpose.
Some information contained in this presentation could contain forecasts and projections characterized by a certain degree of risk and uncertainty and subject to possible amendments.
The actual results may differ significantly from the ones contained in the forecasts and projections due to the risks and future events that are out of Company’s control and that cannot be evaluated in advance, including the global economic framework,the activities carried out by competitors and other entities that are active in the market. Such forecasts and projections are valid only at the date of this presentation. The Company warns that the forecasts and projections that are set forth in thisdocument are not a guarantee for the future and the current financial situation of the Company, business strategy and management objectives for future transactions may differ significantly from the ones presented or suggested by forecasts andprojections that are contained in this presentation. In addition, should the Company’s financial situation, business strategy and management objectives for future transactions be in line with the forecasts and projections contained in this documentthey will not be deemed indicative of the results and the development of subsequent periods. The Company does not undertake any obligation to disseminate any update and/or review of the projections forecasts contained in this document in orderto represent any changes of Company’s projections or any change of the facts, the conditions or circumstances that are forecasts contained in this presentation.
The information contained in this document are valid at the date of this presentation and may be amended without prior notice. The addressee is the only person and entity responsible for its own evaluation of the information contained in thisdocument and of the relevant decision to carry out any transactions suggested or arising out from this presentation. This Company did not engage any independent body for carrying out an evaluation of the Shares and of the assets and liabilities(actual or not) of the Company.
Through the acceptance of this document, the addressee acknowledges and accepts to be bounded to the limits and obligations above.
2
3
1. Overview Rita Paola Petrelli, Co-founder, Chairwoman and CFO
Highlights KOLINPHARMA
KOLINPHARMA, founded in 2013 as Innovative Start-up, now Innovative SME, is specialized in R&S and in the sale of ownbranded food supplement based on natural raw materials, to support pharmacological treatments.
In 2017 KOLINPHARMA registered sales of € 4.1 million, with a growth of 62.3% vs. 2016, and an EBITDA more thandoubled (+130%) to € 0,6 million (EBITDA margin 14.8%).
Even if the competition level of the nutraceutical industry is high and despite the recent history of the Company,KOLINPHARMA is among the top 200 companies (*) for sales in Italy.
The product portfolio consists of 5 KOLINPHARMA branded nutraceuticals, distributed through pharmacies andparapharmacies: Almetax and Ivuxur in the gynecological-urological field, Dolatrox, Milesax and Xinepa in the orthopedic-physiatric field.
KOLINPHARMA is owner of 4 patents in Italy and 9 certifications, of which 2 on the company and 7 on the products.
The nutraceutical sector, that in Italy refers to food supplements that can be marketed only after notification to theMinistry of Health, is characterized by a constant development in Italy. In the years 2013-2017 it constantly grew both invalue (CAGR: +14%) and in volume (CAGR: +17%), reaching a sell-out of € 2.92 billion in 2017. It provides an answer to amore and more relevant need of well-being, in a preventive and not curative way.
With the listing on the AIM Italia on March 9th, 2018 at a IPO price of € 7 and a capital raised of € 3.1 million,KOLINPHARMA aims at speeding up the process of business growth, strengthening R&D and the sales network, currentlymade of 66 medical-scientific informers (MSI), as well as setting up new partnerships.
4(*) Source: QuintilesIMS, data updated as of April 2017
5
2. Nutraceutical market analysis
Dynamics of the nutraceutical market in Italy
PHARMACEUTICAL AND
NUTRACEUTICAL MARKET
ETHICAL SEGMENT
COMMERCIAL SEGMENT
OTC (Over the Counter) SEGMENT
Composed of medications withoutprescription and of all the products
belonging to the nutraceutical market
Drugs prescribed by the physician, all having patent protection
Source: QuintilesIMS Italy – «Il mercato degli integratori alimentari in Italia», Giornale Italiano di Farmacoeconomia e Farmacoutilizzazione 2017
6Source: New Line
Sell-out evolution of nutraceutical segment in pharmacies in Italy(€ bn)
Total sell-out evolution of the nutraceutical segment in ItalyPharmacies, parapharmacies, hyper/super market channels (€ bn)
1,211,38 1,44
1,62 1,66 1,711,86
2,36
2,732,92
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
1,51,7
2,02,3
2,5 2,62,8
3,0
2009 2010 2011 2012 2013 2014 2015 2016
Source: New Line 7
Dynamics of the nutraceutical market in Italy
Evolutive hypothesis of nutraceutical market sell-out in pharmacies in Italy in value
(€ mld)
Evolutive hypothesis of nutraceutical market sell-out in pharmacies in Italy in value
(milioni di unità)
Over the years 2013-2016 the nutraceutical market in Italy has constantly grown both in value (CAGR: +17%) and in volume (CAGR: +21%).
Hence, it is expected that, assuming a constant growth rate, in 2020 sell-out may be equal to 3,70 Euro billion in terms of value and to 257 millions in terms of volumes.
1,71 1,86
2,362,74
2,923,18
3,433,70
2013 2014 2015 2016 2017 2018 2019 2020
112 120
156
197212
225240
257
2013 2014 2015 2016 2017 2018 2019 2020
Analysis of the Italian nutraceutical sector
Source: IMS Health – Multichannel view 8
The nutraceutical market is composed of about 1,800 firmsoperating through the pharmaceutical and parapharmaceuticalchannels. Top 270 firms realize over 1 Euro billion of sell-outand represent 92% of total sell-out of the market.
Market composition
Nutraceutical enterprises: market shares
15% of nutraceutical market’s firms with sell-out > € 1 mln
85% of nutraceutical market’s firms with sell-out < € 1 mln
8% of total nutraceuticalmarket’s sell-out
92% of totalnutraceutical
market’s sell-out
The kind of products launched by KOLINPHARMA on the marketis prescribed by the specialised physician, as part of thetherapy, to the patient, who buys them at pharmacies orparapharmacies.
Actors of the prescriptions
% weight of the prescriptions by medical fields
55,1%
8,6%
8,5%
4,3%
2,9%
2,8%
2,7%
2,5%
2,5%1,9%
8,1%General physicians
Pediatricians
Gynaecologists
Ortho Rheumatologists
Pharmacists a.p.
Ophthalmologists
Neurologists
Internists
Gastroenterologists
Urologists
Other Specialists
Competitive arena and KOLINPHARMA’s positioning
Source: IMS Health – Multichannel view(*) Source: QuintilesIMS
9
Top 15 firms of the nutraceutical sector by sell-out in ItalyPharmacy channel (€ 000, April 2017)
Based on sales as of April 2017 KOLINPHARMA is ranked, still growing, among the top 200 firms (*) of the segment with respect to aninitial ranking based on FY 2014 sales that collocated it among the bottom 400.
Because of the progressive contraction of the ethical segment (pharmaceutical industry), it is necessary to meet a more and morerelevant need of well-being, in a preventive and not curative way.
The offer side of the nutraceutical segment is composed of two types of firms: a) multinational companies of pharma, which look at thenutraceutical market only as a secondary business b) exclusively nutraceutical firms.
112.335
108.555
78.192
71.000
58.427
48.659
45.274
39.338
38.822
38.189
37.159
37.119
35.714
33.314
31.947
Aboca
Pfizer
Sofar
Meda Pharma
Montefarmaco OTC
Named
Pool Pharma
Unifarco
Laborest Italia
Shedir Pharma
Biofutura Pharma
Johnson & Johnson
ESI
Solgar Italia
Giuliani
KOLINPHARMA’s positioning among the 1,800 firms of the market
Nutraceuticals are the new frontier of the
pharmaceutical market
2014 2016 2017
Bottom 400 firms by sales
Top 200 firmsby sales
10
3. Business model
The history of KOLINPHARMA The Company was founded in 2013 by the cooperation of Emanuele Lusenti, manager with a long and consolidate experience in thepharmaceutical and nutraceutical industry, and Rita Paola Petrelli, professional with twenty years of administrative and financial experience.
2013
2014
KOLINPHARMA starts up with the aimof creating food supplements based onnatural raw materials to supportpharmacological treatments of certaindiseases
The Company markets its first fourproducts: Almetax, Dolatrox (formerlyDolasix), Ivuxur and Milesax.
KOLINPHARMA obtains 2 certificationsand the qualification of «InnovativeStart-up»
2015
In March, the fifth nutraceuticalproduct of KOLINPHARMA is released:Xinepa
2016
KOLINPHARMA starts scientificreasearch collaborations with thePharma Department of PaviaUniversity
KOLINPHARMA obtains 3 patents on itsproducts Almetax, Milesax and Xinepa(patent on formulation)
Source: KOLINPHARMA 11
2017
Excellence recognition for Horizon2020 Project
Achievement of the 4th patent Xinepa 2(industrial patent)
Agreement with Calabria Universityfor the experimental cultivation ofplants for nutraceutical use
KOLINHARMA achieves the «InnovativeSME» qualification
March 9th: listing on the AIM Italia market;capital raised € 3.1 million and IPO price € 7
The empirical study conducted at theUmberto I hospital in Rome states theeffectiveness of Xinepa® for the treatment ofperipheral neuropathies
Tender INNODRIVER-S3 – 2017 Edition –Measures A-B-C
Placing on the market of two newpharmaceutical forms, soluble in the mouth:Almetax easy and Xinepa easy
2018
Shareholding and corporate governance
Rita Paola Petrelli Emanuele Lusenti
KOLINPHARMA S.p.A.
52.61% 19.21%
BOARD OF AUDITORS
President: Sergio Saiani In charge auditor: Luigino TonioloIn charge auditor: Francesco Gianluca PecereSubstitute auditor: Nicolò Giuseppe ManzoniSubstitute auditor: Luca Persona
12Source: KOLINPHARMA
Market(other investors < 5%)
28.18%
Rita Paola PetrelliPresident and CFO
Emanuele LusentiCEO
Francesco Maria SpanoIndependent director
Edoardo FerraginaNon-excecutive director
Giannunzio CorazzaNon-excecutive director
Maurizio AltiniIndependent director
BOARD OF DIRECTORS
The subscribed and paid-up share capital amounts to 1,639,571 Euro, consisting of 1,639,571 shares with no par value, of which 1,459,571 are ordinary shares and 180,000 are Price Adjustment Shares (PAS) not listed on AIM Italia and held by the two founding shareholders (Rita Paola Petrelli and Emanuele Lusenti); they alsohave a lock-up of 24 months from the IPO date. The free float of KOLINPHARMA is currently equal to 31.65% of ordinary shares.List vote for the election of the Board: 5% of the capital.
Management Team
Source: KOLINPHARMA 13
Emanuele LusentiCEO
He professionaly debuted as Pharmaceutical Scientific Informer,then covering important executive positions, hence acquiring theexperience necessary to know in depth the operational andstrategic dynamics of both the pharmaceutical and nutraceuticalindustries.
His professional curriculum counts, in executive positions above all,important pharmaceutical firms as Schiapparelli, Sigma Tau, AlfaWassermann, Bracco, as well as firms as Citeza Medicali, leader inthe elastic-compression field, and Laborest Italia, leader in thenutraceutical sector. With respect to KOLINPHARMA, he is co-founderof the Company.
Rita Paola PetrelliPresident of the BoD and CFO
Chartered Accountant, auditor, techinical office consultant for theCatanzaro Court since 2004, still exercising the profession.
Among her professional experiences, she covered the role of SoleDirector of Finanza e Tributi Consulting S.r.l., specialized incorporate services, both fiscal and financial, as well as consultingactivities in the administrative and management field for CalabriarEGION – Environment and Territory Department. With respect toKOLINPHARMA, she is co-founder of the Company.
KOLINPHARMA workforce: 27 employees
The KOLINPHARMA Project
Source: KOLINPHARMA 14
The Project is part of the sector socalled
PHARMACEUTICAL NUTRITIONALNUTRACEUTICAL
The plan aims at creating a series of food supplements, exclusively naturally based, that could support pharmacological therapies with respect to the recognized diseases, principally in the
gynecological-urological and in the orthopedic-physiatric fields
Strategical positioning
15
KOLINPHARMA’s products are placed between the generic common food supplement and the drug. This allows the Company to market its
products adopting a premium price policy, which positions themamong the high-end products within the nutraceutical market,
without any negative effects on the demand side.HIG
H
«TH
ERA
PEU
TIC
»A
CTI
ON
ON
SP
ECIF
IC P
ATH
OLO
GY
MED
IUM
-H
IGH
MED
IUM
-LO
WLO
W
DRUGS
NUTRACEUTICALS
WITH SPECIFIC ACTION
GENERAL COMMON FOOD SUPPLEMENTS
Source: KOLINPHARMA
Business model
Source: KOLINPHARMA 16
INTERNAL FUNCTIONS IN KOLINPHARMA
Research and Development
Marketing
Commercial
Information Technology
Production – PHARCOTERM e PHARMAXIMA
Storage, logistics and transport – BOMI ITALIA
OUTSOURCED FUNCTIONS
Human Resources – ADECCO
NUTRACEUTICAL MARKET
Focus on Research and Development
Source: KOLINPHARMA 17
RESEARCH AND DEVELOPMENT:
Managed internally with the external collaboration
of Italian Universities
Strategic approach based on quality and product
specialisation
The activity of Research & Development, a key activity for the Issuer, is managed internally, with the externalcollaboration of important Italian Universities in order to achieve the best formulative results, using innovativesubstances aiming at achieving the intellectual property. Under the formulation aspect, the Company identifiesthe ingredients in order to realize the compound and it outsources the formulative development.
In 2014 the Company signed a scientific research contract with Pavia University, Pharma Department, having asobjective a monographic research on the antibacterial activity of plant extracts to be used in the healthy productsproduction. In FY 2017 the Firm established an agreement with Calabria University, Pharma Department, for theexperimental cultivation of plants for nutraceutical use.
Through a strategic positioning based on quality, KOLINPHARMA wants to approach the market with a strategyfocused on specific segment of specialization, such as orthopaedics, traumatology and gynaecology.
Moreover the Company takes advantage of the assistance of Consulfarm S.r.l. in the regulatory field, as asupport of the business function, and for the direct relationships with the Health Ministry.
MILESAXDOLATROX ALMETAX IVUXURXINEPA ALMETAX easyXINEPA easy
KOLINPHARMA’s 4 patents
Source: KOLINPHARMA 18
Certifications on Company and on products
Source: KOLINPHARMA 19
Since 2013 KOLINPHARMA aimed at achieving important quality certifications for both the firm itself and for the products, involving theGlobal leader among the Certification Institutions: Bureau Veritas. The achieved certifications are the following:
FOR THE COMPANY:
ISO 9001 and ISO 22000
FOR THE PRODUCTS:
Kosher, Halal, Associazione Italiana Celiachia, Milk Free, Eccellenza di Casa Savoia, Unione Italiana Ciechi (UIC) and Play Sure Doping Free
LAST BUSINESS SUCCESS: PLAY SURE DOPING FREE
In 2016 KOLINPHARMA achieved the certification for the products “Play Sure Doping Free”, released by the company Doping Free S.A.
The certification highlights the composition of the products, guaranteeing that the identity and quantity of the alimentary ingredients asdeclared on the product label does not contain forbidden substances. The list of forbidden substances includes all those banned by the mainsport organizations, such as the World Anti-Doping Agency (WADA).
(being released))
KOLINPHARMA’s under development projects
Source: KOLINPHARMA 20
INNOVATIVE PRODUCTS ALSO FOR NEW MEDICAL SPECIALTIES:
NEUROLOGY AND GASTROENTEROLOGY
INNOVATIVE PHARMACEUTICAL FORMS FOR THE PRODUCTS
UNDER STUDY
INNOVATIVE SUBSTANCES IN THE NEW FORMULAS AND PATENTED
PRODUCTS
INTERNATIONAL PROJECTS NATIONAL PROJECTS INNODRIVER-S3 – 2017 Edition – Measures A-B-C, which will allow to partecipate to the II phase of the HORIZON 2020 project.
The primary marketing function is managed internally through an informative network of 66 medical-scientificinformers (MSIs), specialised professionals mono-agents and graduated in science disciplines. They have therole of promoting KOLINPHARMA’s nutraceutical products directly to physicians, focusing on raising awarenessof Specialists (key opinion leaders, KOLs).KOLs collaborate with the Company on occasional basis in scientific research, development and promotion of theproducts to colleagues and patients; they are therefore the link between the identification of a specifictherapeutic need (on the basis of their daily experience in contact with patients) and the relative R&D of aproduct, with particular reference to those pathologies only partially covered by drugs or other foodsupplements.
Focus Marketing
Source: KOLINPHARMA 21
MARKETING
Function managed internally and based on a
wide network of MSIs, specialised professionals
and graduated in scientific disciplines
Before starting their activity, every MSI have to attend a 4 week training course and assume obligations topromote KOLINPHARMA branded products on an exclusive basis and non-competition restrictions in favour ofthe Company.
The activity of the medical-scientific informers (MSIs) is organized in interim periodical cycles, in line with thecriteria of the pharmaceutical industry:1) identification of a reference disease for each period of the year;2) role playing, i.e. definition of the interviews to be carried out with physicians or pharmacies;3) identification of the reference medical target, according to potentiality categorisation based on the number
of patients and hospital beds;4) use of appropriate communication tools, specifically studied by the scientific, medical and marketing
department.
Medical-scientificinformer (MSI)
Specialisedphysician – KeyOpinion Leader
(KOL)
The direct customers of KOLINPHARMA are the wholesalers, leading pharmaceutical distribution companieslocated throughout Italy. The Company, through the Sales Manager Italy, does not formalize supply agreementswith individual wholesalers, but it agrees individual supply orders from time to time .The MSIs are not authorized to sell the products, which takes place directly by the Company in favour ofwholesalers.
Distribution focus and commercial network
Source: KOLINPHARMA 22
DISTRIBUTION MODEL AND COMMERCIAL NETWORK
Direct clients of the Company are the pharmaceutical
wholesalers, who buy products with a 39.09%
discount of the public price (the same law discount for
drugs)
The manufacturer sells KOLINPHARMA’s products to the wholesaler applying a 39.09% discount compared tothe price tag indicated on the product.The wholesaler then sells the products purchased to the pharmacy or parapharmacy, applying a discount thatvaries according to the relative operating margins.The pharmacy or parapharmacy sells the products bought from the wholesaler to the final consumer, at the pricetag.
Sales Manager WholesalerPharmacies and Parapharmacies
REBATE
PAYMENTS
Law discount on medications – 39.09%
Art. 62 – 60 days
UNPAID None
(+extra discounts from 2% to 4% in July and November)
(+extra 30 days in July and November)
KOLINPHARMA’s strengths
Source: KOLINPHARMA 23
Scientific research and productdevelopment managed internally
Specialisation and expertise of the medical-scientific informers network
Innovative packaging: FSC paper, Tamper Evident closing and Braille for expiration date
and QR code
Patents and quality certifications for the products
and the Company
Use of exclusively natural innovative substances and
«Innovative SME»
24
4. Innovation and R&DValeria Curti, Scientific Manager
Innovative research in KOLINPHARMA
Source: KOLINPHARMA 25
•KOLINPHARMA carries out a detailed study on the raw materials to know all their key characteristics, so that it is able to enhance its benefits (physicaland chemical properties, biological properties and known action mechanisms, human effects) and overcome its limits (physical-chemical and organolepticproperties, bio-availability).
•In the case of plant extracts, these are all standardized and appointed in the active substance that is responsible of the activity. All the raw materials arefirst appropriately dosed to be efficient, based on published scientific evidences.
•The research for new ingredients to be launched in a specific specialized area is constant, thanks to the exhaustive collaboration and the dense networkof suppliers (e.g. ASI in osteoarticular pain, CURCUMA technologically advanced in the orthopaedic and gynaecological fields).
Study of the formulation: choice of the pharmaceutical formula and of the most adequate excipients, evaluation of their compatibility with theactive raw materials, industrial scale-up, execution of stability studies according to harmonized protocols (ICH), suitability of the final product to theorganoleptic specificities and to the normative requirements.
KOLINPHARMA’s interest is shifting from conventional pharmaceutical formulas (e.g. tablets, capsules, hydro-soluble granulates) to innovative ones(e.g. buccal, sublingual, mucus-adhesive, etc.) in order to maximize the therapeutic efficiency of its products.
Exploitation of the final product:- High qualitative standards: the product needs to meet not only sector specific regulatory requirements (e.g. permitted ingredients, dosage of theexcipients), but also to quality and dietary requirements (HACCP of process and product, analytical plan of similar-pharmaceutical batch release);- Scientific validation (in vitro studies and human studies, designed internally and carry out with the collaboration of important research centres);- Patenting: the products need to satisfy the requirements of INNOVATIVE ACTIVITY, INNOVATION AND COMMERCIABILITY. Today KOLINPHARMA canboast 6 filed patent applications in Italy, extended also to foreign countries; 4 of these are granted Italian patents and one in the process ofpublication.
FUTURE OBJECTIVES: to launch on the market new products characterized by an innovative formula, scientifically validated, together with a patent application, all meeting high quality and control standards for consumers.
Innovative research in KOLINPHARMA
Source: KOLINPHARMA 26
ANNUAL GLOBAL EVENT IN THE FIELD OF NUTRACEUTICS
UPDATE ON INNOVATIVE RAW MATERIALS
SCIENTIFIC UPDATES
MEETING PLACE WITH SUPPLIERS
MARKET TRENDS
Scientific approach in KOLINPHARMA
Source: KOLINPHARMA 27
Our scientific communication is based on informative transparency and is targeted to the specific recipient
SPECIALISED PHYSICIAN
Drug-centric approach
Evidence-based medicine Evidence-based nutraceuticals
Scientific rational
Razionale scientifico
Hospital Meeting
PHARMACIST
Formulation quality because it is supported by innovative raw materials
Company’s and products’ certifications (gluten free, milk free)
Drug-centric approach
Store Meeting
The innovation in KOLINPHARMA’s products
Source: KOLINPHARMA 28
Food supplement as a solution against arthropathies andosteoarthritis, based on MSM, ASI, SAM and Vitamin C, Copperand Manganese. The Vitamin C contributes to the formation ofcollagen for the normal functioning of gristles, Copper andManganese to the maintaining of normal connective tissues.
MILESAXDOLATROX (EX DOLASIX)XINEPA – XINEPA easy
Food supplement indicated for mechanical peripheral, post-traumatic or crush neuropathies, based on alpha-lipoic acid, N-acetyl L-carnitine, curcuma, vitamin B, E and C. Vitamins B1, B2,B6 and B12 contribute to the normal functioning of the nervoussystem and of the energy metabolism; also B2, B6 and B12 canhelp in the case of tiredness and fatigue.
Food supplement recommended for muscle relaxant and anti-inflammatory treatment, based on magnesium, boswelia, L-tryptophan (a precursor of serotonin). Magnesium contributes to the normal muscular and psychological function. Bosweliacombats localised states of tension.
ALMETAX – ALMETAX easy IVUXUR
Food supplement for women in their menopause, based onalpha-lipoic acid, L-tryptophan, Curcuma, Vitamins B5, B6,Chromium picolinate, Zinc and Vitamin C. Especially, Vitamin B5helps the digestion of fats, Chromium contributes to themaintenance of normal glucose levels in the blood; Zinc helps tokeep normal testosterone levels in the bloodstream; Vitamin B6contributes to the regulation of the hormonal activity; Curcumais recommended to combat the symptoms of the menstrualcycle and to inhibit factors of inflammation.
Food supplement to prevent and contrast urinary tractinfections. The product is made of cranberry (dry extractedfrom pulp, seeds and peel of blueberries), D-mannose,bearberry and Zinc. Cranberry and bearberry are useful for thewellness and functionality of the urinary tracts. Zinc, as well asbeing helpful for the normal functioning of the immune system,contributes to the protection of cells from oxidative stress. D-mannose performs an anti-bacteria action.
29
5. Financial highlights
2016-2017 Profit and Loss account
Source: KOLINPHARMA’s annual reports and Management Accounts 30
2.504
4.063
2016 2017
Sales 2016-2017(€ 000)
EBITDA 2016-2017(€ 000)
EBT 2016-2017(€ 000)
The Company, founded in 2013, today Innovative SME, in 2017 registred a turnover of 4.1 Euro million, with a growth of 62.3% with respect to 2016, and with an EBITDA more than doubled (+130%) to 0.6 Eu million (EBITDA margin 14,8%).
+62.3%
262
603
2016 2017
(390)
(43)
2016 2017
+130.2%
+88.9%
2016-2017 sales breakdown
Source: KOLINPHARMA’s annual reports and Management Accounts 31
2016
Almetax 12,5%
Dolatrox16,0%
Ivuxur 16,5%Milesax
25,6%
Xinepa29,4%
2017
Almetax 11,6%
Dolatrox17,1%
Ivuxur 15,9%Milesax
28,5%
Xinepa 26,9%
€ 2.5 mln € 4,1 mln
KOLINPHARMA’s products prescriptions 2015-1st quarter 2018
Source: Quintiles IMS 32
Number of prescription per IMS per geographical area (thousands)
Distribution throughout the national territory
(only top 10 Italian regions)
2018: data as of March 31st growing in all the top 10 Italian regions
12
15
68
25 4 4 4
7
23
28
1716
6
13
1011
87
43
32
30
26
2421
19
14 1312
14
9 98 8
6 63 4 4
LOMBARDY CAMPANIA LAZIO PIEDMONT VENETO TUSCANY PUGLIA ABRUZZO CALABRIA SICILY
2015 2016 2017 1st quarter 2018
2016-2017 Profit and Loss account
Source: KOLINPHARMA’s annual reports and Management Accounts 33
Values in thousands of Euros 2015 2016 2017
Sales 1,255 2,504 4,063
YoY growth 99.5% 62.3%
Changes in inventories of in progress, semi-finished and finished products
29 209 42
Increases in fixed assets for internal works 901 1,011 1,208
Other revenues and income 37 52 35
Value of Production 2,222 3,777 5,349
Costs for raw materials, ancillaries, consumables and goods (626) (1,208) (1,329)
Services costs (1,355) (1,895) (2,610)
Costs for enjoyment of third parties’ assets (13) (21) (78)
Personnel costs (527) (357) (676)
Other operating charges (51) (33) (52)
EBITDA (348) 262 603
EBITDA margin -27.7% 10.5% 14.8%
Depreciations and Amortisations (613) (586) (572)
EBIT (961) (324) 31
Net financial income (charges) (23) (66) (75)
EBT (984) (390) (43)
Taxes 232 24 (23)
Net result (752) (366) (66)
COMMENTS
Sales growth (€ 2.5 million in 2016 and € 4.1 million in2017) was linked to: development of the commercial network (from 35 to
58 MSIs as of December 31st, 2017); increase of the number of prescriptions by the
medical class; prices increase of 3% with respect to the previous
year.
EBITDA margin improved from 10.5% in 2016 to 14.8%in 2017, mainly thanks to: lower incidence of samples’ costs (free trial samples).
With the consolidation of KOLINPHARMA within thenutraceutical market, the necessity of promotingproducts through samples’ distribution decreases;
on the contrary an increase in R&D costs andpersonnel costs (employees went from 8 to 12 as ofDecember 31st, 2017) was registered.
Break-even point was reached at EBIT level and almostreached at net result level.
2016-2017 Balance sheet
Source: KOLINPHARMA’s annual reports and Management Accounts 34
COMMENTSValues in thousands of Euros 12/31/2015 12/31/2016 12/31/2017
Trade receivables 704 1,128 2,141Inventory 120 329 371Trade payables (739) (1,172) (1,717)Trade Working Capital 85 285 795Other current assets 319 456 422Other current liabilities (110) (215) (269)Net Accruals and Prepayments (14) (140) (299)Net Working Capital 280 386 648Net intangible assets 1,998 2,433 3,089Net tangible assets 26 30 43Net financial assets 2 0 11Net fixed assets 2,027 2,463 3,143Severance pay fund (16) (29) (50)NET CAPITAL EMPLOYED 2,291 2,820 3,742Financial liquidity (274) (28) (15)Third-party financing 0 180 180(Net) short term bank debts 343 944 1,535Medium-long term bank debts 1,029 766 796Net financial debt (Cash) 1,099 1,862 2,496Share capital 1,000 1,000 1,000Reserves and capital increase account 208 268 1,430Retained profits (losses) 0 (752) (1,118)Net result of the fiscal year (752) (366) (66)Equity 456 150 1,246Sheareholders’ loan 736 807 0Own financial resources 1,192 957 1,246TOTALE SOURCES 2,291 2,820 3,742
Net Working Capital raised, which reflects the start-upphase where KOLINPHARMA is.
In 2017 the Company made € 1.2 million of gross capex (vs.€ 1 million in 2016) in intangible assets and, in particular:
industrial patents and intellectual property rights for €597 thousand;
plant and expansion costs (R&D costs, expenses for thepurchase of Nutraceutica database and website, costs forlisting on AIM, commission payments to MSIs and theirtraining courses) for € 569 thousand;
trademarks registration costs, but above all priorresearches for these registrations, for € 42 thousand.
Net financial debt as of December 31st, 2017 was equal to €2.5 million.
Equity as of December 31st, 2017 was equal to € 1.2 million.
35
6. Strategy
Strategic guidelines
Source: KOLINPHARMA
1Reinforcement and acceleration of the scientific research projects and development of new products with new pharmaceutical forms
2Strengthening of the MSIs network in the Italian market and creation of a comparable structure in the target foreign markets
3External growth through agreements with other players and extraordinary transactions, also abroad
4Increasing of the patent portfolio of all the products in development and those commercialised in Italy
5Carry out clinical research activities, also supported by ethical committees, in support of scientific communication
6Highly scientific communication to the reference specialised medical class and available throughout the national territory
Use of IPO proceeds
37Source: KOLINPHARMA
N° OF MSIs 37 66 150
N° OF PRODUCTS 5 5 15
LABORATORY OR RESEARCH CENTER
0 0 1
POSITIONINGAmong the top 200
nutraceutical companies in Italy
Among the top 200 nutraceutical companies
in Italy
Aims at ranking among the top 20 nutraceutical
companies in Italy
2017A TODAY 2020E
38
7. Partners & Contacts
Partners
39
NomAd & Global Coordinator Financial Advisor Legal Advisor
(collocatore online e retail)
Auditing FirmEquity Research Investor & Media Relations
40
ContactsKOLINPHARMA S.p.A.REGISTERED OFFICEVia Larga n°8 – 20122 Milan (MI)
OPERATIONAL HEADQUARTERSCorso Europa n°5 – 20020 Lainate (MI)Ph. +39 02 94324300
Milan Companies RegisterNum. Reg., F.C. and P. IVA: 08331990963R.E.A.: Mi 2018304
IR Top Consulting S.r.l. Investor & Media Relations Floriana Vitale, Domenico Gentile [email protected], [email protected] C. Cantù n°1 – 20123 Milan (MI)Ph. +39 02 4547 3883/4
EnVent Capital Markets Ltd. Nominated Adviser (NomAd) Francesca Martino [email protected] Berkeley Square – London W1J 5AW Italian branch, Via Barberini n°95 – 00187 Rome (RM)Ph. +39 06 896841
41
Appendices
Price Adjustment Shares (PAS)
Source: Admission Document (*) not listed on AIM Italia
Rita Paola Petrelli&
Emanuele Lusenti
FOUNDING SHAREHOLDERS
N° 180.000 (*)Price Adjustment Shares
(PAS)
hold
CANCELLATION/CONVERSION MECHANISMS
EBITDA 12/31/2017
EBITDA 12/31/2018
< € 500,000.00 > € 500,000.00 > € 1,400,000.00 < € 1,400,000.00
Cancellation of 166.667 PAS
PAS will remain at the service of
conversion into ordinary shares (no
PAS will be cancelled or converted)
Outstanding PAS will be converted
into ordinary shares
All the outstanding PAS will be cancelled
If the EBITDA as of December 31st, 2018 was higher than € 1,400,000.00 but the EBITDA as of December 31st, 2017 had been lower than € 500,000.00, hence only
the remaining 13,333 PAS will be converted into ordinary shares
42
The Company adopted a mechanism according to which, in case of failure to achieve certain profitability targets for FY 2017 and 2018, thenumber of shares hold by the Founding Shareholders will decrease and, consequently, the percentage share of capital hold by othershareholders will increase.
The profitability targets included in the mechanism are, for 2017, an EBITDA higher than € 500,000.00 and, for 2018, an EBITDA higher than€ 1,400,000.00. In case of partial or total failure to achieve these targets PAS are cancelled, in order to increase the share of capital hold byother shareholders. Vice versa, if the targets are achieved, PAS will be converted, totally or partially, into KOLINPHARMA ordinary shares.
President
Rita Paola Petrelli
CEO
Emanuele Lusenti
HR
Emanuele Lusenti*
Payroll
**
Purchasing office
Patrizia Cafaro*
Events & Meetings
**
Processes
Patrizia Cafaro
Logistics
Gruppo Bomi (**)
IT / EDP
**
CFO
Rita Paola Petrelli
Accounting
Stephane Sossou
Marketing
Emanuele Lusenti*
Product Specialist
Danilo TrentinElena Pasoski
Sales in Italy
Carmine Di Vincenzo
Key Area Manager
Silvio Di Foggia
Area Manager
MSIs
QA Regulatory AffairsVeronica Di Pietro
Quality management
Patrizia Cafaro
13485
RSPPPrivacy
**
231Superv. Board
**
R&D
Arianna Di Lorenzo
Technical Scientific Man.
**
Scientific area
Emanuele Lusenti
Scientific Manager
Valeria Curti
Medical Manager
Daniele De Filippis
Statistic Manager
**
Legal
**
International Manager
Luigi Sprovieri
• Ad interim ** External consultantsSource: KOLINPHARMA
43
N° of employees: 27N° of MSIs: 66 (95% graduated)
Organizational chart
Key roles in the KOLINPHARMA model
44
Every pharmaceutical formula, being it solid, semisolid or liquid, chosen for a launching product, must be studied by TSM, a role with deeptechnical-scientific knowledge, in such a way that the active substances and the used excipients can make the product more bio-available andthat can grant the industrial process with absolute ease and quality.
The product manager is an extremely important role in the Company, because he studies a lot factors, essentials for the development of eachproject: from the market of interest, the firms that are part of it, the launched products, to the medical fields involved, from the studiedtherapeutically areas, to the referred disease, from the communication to the physician, to the target under study, from the policy price, tothe specialised marketing.
He/She intermediates between the requirements of the Ministry of Health and all the needs expressed by the specific functional areas ofthe Company. When he/she submits an application for the launch of a new product in the market, the function has to provide, in support ofthe authorization request, a specific documentation covering a lot of aspects, among which: the prescription, the product label, the usedbrand, the used formula and the package leaflet. He/She interacts with the regulatory manager of the industrial manufacturer of the productthe Company is interested to launch.
Source: KOLINPHARMA
A fundamental role to develop the products portfolio of the Company. He/She is always looking for innovative substances, with high titlingand that can well respond to the therapeutical segment under study. Innovative substances are essential to create of formulas that can answerto synergies of actions, hence aiming at making them patentable. To achieve and support this objective, he/she carries out important pre-clinical studies.
R&D MANAGER
TECHNICAL SCIENTIFIC MANAGER
PRODUCT MANAGER
REGULATORY AFFAIRS MANAGER
Key roles in the KOLINPHARMA model
45
Each new product launched has to provide, in advance, besides the in vitro studies, also and most of all human clinical studies. Real-life,observational, multicentre, with the involvement of ethical committees, are some examples of studies that need to be carried out accordingto predefined protocols, also with the medical class involved. The Medical Manager has to validate that every kind of communication to thephysician is coherent, valuable and demonstrated.
There is no clinical study without an involved mathematical figure in the analysis of the collected data. The more complex are the protocoland the geography of the data collected by the KOL physicians involved in the clinical studies, the more necessary is to have a statistician thatcan represent the trial results through appropriate communication tools, that will be brought to the physician. The studies can be real-life,monocentral or multicentre, observational, … etcetera.
An extremely important figure which, by cooperating with R&D, studies the formulation and then defines the communication processes tothe specialist, according to the studies carried out on the product and the international literature which supports its value. He/She preparesthe scientific material to be used during meetings with the doctor in support of the product, the used substances and the active ingredient,besides proving its effectiveness.
Source: KOLINPHARMA
With the new International Division it is important to come at the direct construction of know-how, essential for achieving internationalmarkets, carrying out activities such as: analysis of the international market (focus on the European market), identification of strengths andbusiness opportunities (regulations and market proposals), research for new developing markets, selection of countries with regulatorysimilarities and analysis of the market even at the intercontinental level. Create an own assets of dialogue with associations, federations andgovernment institutions.
MEDICAL MANAGER
STATISTIC MANAGER
SCIENTIFIC MANAGER
INTERNATIONAL MANAGER NEW
46
Innovation and R&DArianna di Lorenzo, R&S e Regulatory e Valeria Curti, Scientific Manager
Regulatory Affairs aspects of the nutraceutical market
Source: IMS Health – Multichannel view 47
Food supplements are defined as alimentary products aimed at integrating every-day diet and that are a concentratedsource of nutritive substances, such as minerals and vitamins or other substances with a nutritive or physiological effect,especially but not only, amino acids, essential fatty acids, fibers and vegetal extracts, both single-substances products andproducts made up of more substances, in pre-dosed formulas suitable to the assumption of small quantities.
Pre-dosed formulas: kinds of products
sold on the market
Capsules and tablets Small bags with powder Liquid vials Bottles
2002/46/CEDIRECTIVE
All the nutritive substances or others that characterize the product (like vitamins, minerals,amino acids and probiotics) must be written on the label, as well as the daily dosagerecommended to achieve the desired result. Moreover, additional warnings/instructions mustbe indicated too (Reg. 1169/2011 on labels and D.Lgs. 145/2017 on the requirement toindicate the production plant).
Neither false, ambiguous or misleading; they cannot leave space to any doubt on the clearnessand adequateness of other foods, neither they can encourage or tolerate excessiveconsumption of a dietary or food supplement; they must not refer to changes in thephysiological functions that could worry consumers.
They need to be scientifically tested, well defined and verifiable, since it is not possible to confer to food, hence also to food supplements, any health properties and general benefits
Nutritive and physiological effect: Claim Reg. 194/2006 and Reg. 432/2012
Nutritive substances
Grocery productsBeing grocery products, food supplementsneed to satisfy the dietary Quality andControl requirements
Reg. 178/2002 (general rule); Reg. 852/2004 (alimentary hygiene); Reg. 882/2004 (official controls); Reg. 1333/2008 (additives) and 1334/2008 (aromas); Reg. 1881/2006 (taints); Reg. 2073/2005 (microbiological criteria); Reg 396/2005 and following updates (residual pesticides); Reg. 828/2014 (gluten).Voluntary-based norm ISO 22000:2005.
Vitamins e Minerals (Reg 1170/2009) DM 24/03/2014 (still under review) Other substances and nutrients National Guide Lines
The horizontal and vertical guide line restricts the use of substances within food supplements,in terms of kind, source, dosage, and if occurring, of warnings to be reported on the label.