EFTA01099293.pdf

STOCKHOLM CORPORATE FINANCE DIGNITANA Management Presentation Increasing the quality of life for breast cancer patients undergoing chemotheraphy by helping them keep their hair Jan Richardsson, Dignitana AB April 2016 10:4040B01131T EFTA01099293  STOCKHOLM CORPORATE FINANCE AGENDA 1. The Company and go to market strategy 2. The Market 3. Investment Case 4. Appendix KONFIDDITIELLT EFTA01099294  Dignitana in short • Dignitana, founded 2007, is a world leader in medical Full year Fu0 year scalp cooling technology. Ellinitana 2016 2014 (Group) (Al) • The company is listed om Nasdaq First North IKSEKI • DigniCap reduces hair loss when patients are going Total revenues S 901 21 219 through chemotherapy is used worldwide. • In December 2015, the DigniCap scalp cooling Net profit after Mandel items -16 569 -10 914 system was cleared by the FDA. Cash and bank balances 19042 1094 • Chairman of the board is Semmy Ralf. former flort0 1015 Pr tocos of at 010'Nev 103 ett• to ncewe me 104 atrovoe.“.014. Viuolife, Jolife, ProstaLund. current board member 0.41.40 OrOtr1ViCkOet Rest tatneiCS ANC fOriCuslt eat. IttS0t comb...wry IF war. Xvivo Perfusion and the CEO is Jan Richardsson. Number Pimento...I former Nedemian, HemoCue and current board Shareholder en 11December 1015 capital end member in Phase Holographic Imaging. fl ares fin Eur0tund 3 750122 2 Anna PMNaO 2 112 906 C3 Dena Panne." LP 1653 551 nortinet Pennon 601756 WON% Pitt SA Colt Vonturos 629 397 101, Flotco,Fenner & Smith Inc. 371066 Somme Ball 315 079 Ceibonlc I atiT-0-orks Schnb.New Tort. 251233 Citibank COLDN-USS, London 151000 %Hum Cron 107021 01hott 6 727 015 Sum 16 774 154 100 3 NOW031111118.LT EFTA01099295  STOCKHOLM CORPORATE FINANCE DigniCap — Components The DigniCap-system consists of four main parts: - A cooling and control system (DigniC3). • A form-fitting silicone cap (DigniCap) connected through tubes to the cooling unit. - An isolated outer neoprene cap, which is placed over the silicone cap. Orgy.< 1 DigniCap IMgnl l ham ondrol peon Sdkiat w Dian c.r. EFTA01099296  Patents ✓ Temperature Sensors 4-1From Coo,. neiin - mem rapin, :OM -N.. 6,41NS 'II :OM ✓ 2 Separate Coolant Circuits Temperature Sensors DigniCapTM has patented temperature sensors integral to the cap itself and which are positioned on the scalp — one at the front section, one at the rear and a safety sensor positioned midway between the two to prevent the temperature falling below 0°C, for example in a system failure. The system has self-regulating functions to immediately detect and EFTA01099297 adjust any temperature deviations. Benefits: i? Software picks up temperature variations i? Controlled temperature regulation i? Constant temperature regulation i? Measurable temperature regulation i? Optimum, system-regulated cooling front and back i? Automated temperature regulation with minimal interruption to and supervision by Nursing staff i? Patient safety EFTA01099298 2 Separate Coolant Circuits DigniCap TM has two independent sections — Front and Rear. The front of the scalp is naturally warmer on any person and can become warmer, perhaps due to stress, worry, physical reactions to anti-emetics/ pre-meds and vesicant, irritant and active drugs. The DigniCap TM system sensors and software, instantly record and correct any temperature variations on the patients scalp i.e. the correct amount of coolant is provided to whichever fluid labyrinth to stabilize and maintain an even scalp temperature. A pulse function has been EFTA01099299 implemented for even distribution of the liquid coolant through. i? Optimum cooling front i? Optimum cooling back Conclusion The DigniCap TM system sensors and software, instantly record and correct any temperature variations on the patients scalp i.e. the correct amount of coolant is provided to whichever fluid labyrinth to stabilize and maintain an even scalp temperature. EFTA01099300 A high demand for scalp cooling • Hair loss associated with chemotherapy is a very distressing side effect — reducing hair loss contributes significantly to the increased well-being and quality oflife for patients. • Most will lose their hair during chemotherapy. • Approximately 3 out 4 patients who use Dignitana's system when treated with chemotherapy for breast cancer can keep their hair. • 400 systems have been delivered worldwide and more than 15.000 patients have been treated. Before After Before After VS Without DigniCap With DigniCap 6 nOlVi0E•J EaT EFTA01099301  STOCKHOLM CORPORATE FINANCE Business Model Worldwide Region/Saks Channel Comments LISA Lease & Pay per - Own sales a treatment organization CC CC Asia IC~onica Minolta Sold as stand-alone a systems & CiL raphie Ine Sold as stand-alone a a systems - Own sales force in Sweden KONFIDOTEILT EFTA01099302  STOCKHOLM CORPORATE FINANCE Business Model U.S. • U.S. is the main market for the Company and represents half of the total medical device market. The Company has since the FDA (Dec. 2015) clearance established its own organization in the U.S with headquarter in Dallas. FDA News Reloaso • Taking over personnel who previously worked with FDA allows marketing scalp cooling enabled direct access to customers. of cooling cap to - Standard contract: two year lease at 600-1,000 reduce hair loss during USD/month plus 175-350 USD/treatment. chemotherapy I ewe e a - Service agreement with Siemens. KONFIDENTIDAT EFTA01099303  Signed Sites since Jan.-16 in the U.S. • Charleston Hematology Oncology Associates • Chesapeake Oncology and Hematology Associates • Florida Cancer Specialists & Research Institute • Mount Sinai Comprehensive Cancer Center • Orange County Blood and Cancer Care • The Angeles Clinic and Research Institute, an afailiate of Cedars-Sinai • Toledo Clinic Cancer Center • UCSF Helen Diller Family Comprehensive Cancer Center • UT Health Science Center San Antonio's Cancer Therapy & Research Center • Wake Forest Baptist Medical Center Approx. 80 quotations have been sent to customers 9 EFTA01099304 Target USA • Target Comprehensive Cancer Centers (42) —reference sites • 2016: > 100 units delivered • 2017: > 250 units delivered • 2016: > 4,000 treatments • 2017: > 20,000 treatments • Reimbursement ready by 2017 10 EFTA01099305  Agenda 1. The Company and go to market strategy 2. The Market 3. Investment Case 4. Appendix KONFIDOITIELLT EFTA01099306  S: K COS : : : %T r FIN V1 Production in Sweden • There are no bottlenecks in production • Cooling unit: Scanfil, Atvidaberg Sweden • Cooling cap: GGF, Gotland Sweden • Potential: 3000 units/year xcesternacr EFTA01099307  Market size breast cancer • Breast cancer is the most common malignancy in women worldwide. I lulliUSI • Approx. 1.5 million new breast cancer patients are diagnosed worldwide each year. HEALTHY LIVING The FDA Just Approved • The US market for scalp cooling is Something That Could Make worth approx. $400 million/year. Cancer More Bearable a Approx. 235,000 new breast cancer Scalp Gaoling cops could PIO) breast patients are diagnosed per year in the cancer patients keep their hair. United States, of which approx. 60% can use DigniCap. December 8 3315. murce: buffpom 13 KONciDEVI- Eur EFTA01099308  Consumer (online) Survey US Market • 400 females was selected: - All ethnicities - All states - Wide range of household incomes - Without pre-knowledge of previous diagnoses diseases - Age: n•400 10.49 125 5059 175 anunelyeldrig Onto las reduce la Na erne thentalharrn 60.older 100 R 2016 utnx !meta int Celt" talmens. KONF11111MEILT 14 EFTA01099309  STOCKHOLM CORPORATE FINANCE Interest Level on Scalp Cooling After a short Introduction on scalp cooling, among 400 females: 96.1% would be interested in scalp cooling woad der witty .ninieresied r. W swebrery be ..inlerened I S. . Moog POMMY b ninitede Woula 001n4yin Lri.Vreca0 Mullprob./31y b• Irallettild VIOJCIprObaD y .ri ,naceritcl denley trevirentosiel xowternacr I5 EFTA01099310 Ranking of Chemotherapy Side-Effects • Among 36 who have been diagnosed with cancer Ranked lst adon down by CA 7.5% 5.6 — aS• 06 ono** DITIratild owrei. 16 Pus Lan Allman Uksaza an.ao neon Perbrilltif O. 666,6 60666 frint.n. red CrOterel papa eints too mann ••• UMW, ■ • • • ■Calm • • • 16 KOMFIDOMELLT 16 EFTA01099311 Selection of Medical Center After a short introduction on scalp cooling, among 400 females: 80.5% find the availahility of cralp cooling important brewery uni•Ipslini Zosawhal veal...Mani 4% N.WW.imponani ma. 138% leare•al Enormity inpalaill ■ SOSIONNIrrpalent 110010I101:0111/010t ■ 54ppµ,prpp.porrll EnomVy unrcutani 17 Kopanownewr 17 EFTA01099312  S7 ( .KHO, ',1 CORPORATE FINA\CE Dignitana Media Strategy CBS hlOining News 1.4114011. a Devic• May Spar* Hair Of Gamin' Moots A Lt.:Tiers-- Lehd•Ilikillt0.••••••••••••114144 mi... • immow••••• •••• 1.1••••••• • • •.N• l•• ••••• Soot OEM • •••••••ali••••••••••••••• gms•••m. Imams •.••••• •••••••••••• •••••m•••••• •••••• %sm. arect• - 47 ===r--r- •••••••••••••••• ••••••••• •miamm •rws•••• NBC Nightly he‘. • In addition the DigniCap-system has also been included in New York Times Science I8 SION:i0ENTST EFTA01099313  STOCKHOLM CORPORATE FINANCE Agenda I . The Company and go to market strategy 2. The Market 3. Investment Case 4. Appendix KONFIDEN11ELLT EFTA01099314  The people to execute the business plan Board Distnitana: t& una: Seamy Rig Magnas Nilsson Born 1950 Born 1956 Chairman of the board since 2014 CEO X‘ivo Perfusion AB Others: Board member Xsivo Perfusion AB and Incentive Others: CEO Virrolife AB and senior posirions at KaroBio and AB. Fortner CEO of Axis and ProstaLund (holds 335 079 Phannacia & Upjohn AB shire% in Me company) Others: Chairman of the boordAridieare. member of the bord Jaen Stamby Xvitn Perfusion. Sensodeci All & Camera Makeeh AB. !km 1961 Former CEO Jobfe AB & lastm AB Chairman ofMe boon! Burresund AB. major shareholder in (holds 30 5S4 shares in the company) Digniuna AB. Bill Cronin Others: Member ofMe boon! in Precella AB. Nartilus AB. Born 1961 Pere>: AB and Tochnovolais COO Ommiana Im (holds 3 835 676 shams in the company) Others: Former CFO Direct Trading Instiumonal and Erik won Seiwak Managing Director at Knight Capital Group. Founder Chan Born 1964 Cold Cap VP Physio-Control Inc (bolds 1800 572 Mares in *re company) Others: Chairman of the board/Valente. member of the hoard %vivo Perfusion. Seroodcet All & Carom Medrech AB. Former CEO Sol ifc AD de Junta AB (holds 10000 Mare% in Me company) 20 nOtici00 vriEly. EFTA01099315  The people to execute the business plan, cont. Xlarnament Divnitarta: Xlanasunent Dionimm: Jan Abbate-son £r&a Bigeraan CEO Dioniuna An Born 1979 Born 1960 Clinical Affairs Director Dignitana All Others: Former VP Sales Nnicroun tinkling AB. Sales Others: Master of Science Biomedical Chemistry. PhD Experimental Director IlemoCue AB. Board member Phase tro)ographic Oncology Imaging, Moran Faxtighet, AB (holds 796$ shares and ID 000warrants in the company) (holds 40547 shares and 1O1 OD warrants in the company) Maelthrine Roos Tobias Frit. Born 1979 Born 1979 CVO COO Dignitara AM in charge of productica. development Others: Matto; of Science Business Administration and Economics Others: Master of Science. Lands University (holds 6416 shares and 10 000 warrants in the company) (holds 5016 shares and 10000 warrants in the company) &moot Ljeagetrim Born 1964 Duality Assurance Director Others: Minter of Science Biotechnology. Research Scientist & OA manager within device and phamuceutical industry at AstraZenica and Gambro ilekl• in blare Isikant.04 21 KOKIO€TELLT EFTA01099316 Investment case • Large market potential in the U.S. • Breakthrough in December 2015 with FDA clearance. • First mover advantage. • Own organization established in the U.S. • Improved business model in U.S., pay-per-treatment + leasing of the machine. • High margins. • Ten contracts already signed in the USA as of end of march. • The US market is valued to approx. $400 m yearly. 51 ACW,OENT Ear EFTA01099317  Investment case - High demand with proven effect • Approx. 400 systems world wide have been delivered and more than 15,000 patients have been treated worldwide with DigniCap. • Excellent new management with proven track record from the medical device sector. • Chairman Semmy RiiIf has a long experience from the medtech- sector. • CEO Jan Richardsson previously VP sales Nederman and HemoCue with proven track record from developing sales organizations. • In the USA Bill Cronin is the COO of the US office and is also a large shareholder. Former CEO Managing Director at Knight Capital Group. Founder Chemo Cold Cap. • Large media coverage in the USA since the launch drives market demand from patients and clinics. 23 • ..t=ioe sr ELL EFTA01099318  The Offer and Use of Proceeds The Offer Use of proceeds Transaobare Directed Snare true us. ate 2043 MSEK Total transaction sure: 40 MSEK Product deveopment 10-15 A1SEK New shares in orected share issue: about 1.9m2.5m Other activities 5.10 MSEK about 10%-15% Pro-money valuation: ILO MSEK Subscription once: Bock bulking Subscription period (prehrninaty): Second half ofPO 2018 Payroll data (pearrina End May 2018 • After the directed share issue is completed, the Company intends to cony out a rights issue of about 15 MSEK at same terms as in the directed share issue. $.00/giOESIT EU? EFTA01099319  Agenda I . The Company and go to market strategy 2. The Market 3. Investment Case 4. Appendix Komnotoineur EFTA01099320 The Share Volume wheighted average share price: SEK 15-d 19,2 30-d 21,3 Since beginning year 20,9 Share volume: 15-d 479 575 30-d 508 319 Since beginning year 906 996 26 EFTA01099321  Car r Principle of Scalp Cooling • An Individual has an average of approximately 100,000 strands of hair Reduced iemperanue on the head and each hair grows In a follicle. In the scalp there are small blood vessels that supply the follicle cells with nutrients and oxygen as well as remove waste products. • When an individual is undergoing chemotherapy treatment, eflostatic Reduced blood few Reduced renew roe will inevitably be transported to the (Perfueron) IMMEO31/5/A) follicle through the blood vessels. • By cooling the scalp in conjunction with a chemotherapy, blood vessels in the scalp becomes smaller and thus less blood, and consequently less cytostatic drugs, pass to the hair follicle. !roc, snob and ddinn Hair cell survival 27 xcesterinewr EFTA01099322 ripDIGNE6,N., EFTA01099323