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efta-efta01099293DOJ Data Set 9Other

STOCKHOLM

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EFTA Disclosure
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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 AGENDA 1. The Company and go to market strategy 2. The Market 3. Investment Case 4. Appendix KONFIDDITIELLT STOCKHOLM CORPORATE FINANCE EFTA01099294 Dignitana in short Dignitana, founded 2007, is a world leader in medical scalp cooling technology. The company is listed om Nasdaq First North DigniCap reduces hair loss when patients are going through chemotherapy is used worldwide. In December 2015, the DigniCap scalp cooling system was cleared by the FDA. Chairman of the board is Semmy Ralf. former Viuolife, Jolife, ProstaLund. current board member Xvivo Perfusion and the CEO is Jan Richardsson. former Nedemian, HemoCue and current board member in Phase Holographic Imaging. NOW031111118.LT Full year Fu0 year Ellinitana 2016 2014 (Group) (Al) IKSEKI Total revenues S 901 21 219 Net profit after Mandel items -16 569 -10 914 Cash and bank balances 19042 1 094 flort0 1015 Pr tocos of at 010'Nev 103 ett• to ncewe me 104 atrovoe.“.014. 0.41.40 OrOtr1ViCkOet Rest tatneiCS ANC fOriCuslt eat. IttS0t comb... wry IF war. Shareholder en 11 December 1015 Number fl ares Pimento...I capital end fin Eur0tund Anna PMNaO C3 Dena Panne." LP nortinet Pennon WON% Pitt SA Colt Vonturos 101, Flotco, Fenner & Smith Inc. Somme Ball Ceibonlc I atiT-0-orks Schnb. New Tort. Citibank COLDN-USS, London %Hum Cron 01hott 3 750122 2 112 906 1 653 551 601 756 629 397 371066 315 079 251 233 151000 107021 6 727 015 2 Sum 16 774 154 100 3 EFTA01099295 DigniCap — Components STOCKHOLM CORPORATE FINANCE 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 ondrol peon DigniCap IMgnl l ham Sdkiat w Dian c.r. EFTA01099296 Patents  Temperature Sensors 4-1From Coo,. nei in - 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 of life 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 VS Without DigniCap Before After With DigniCap 6 nOlVi0E•J EaT EFTA01099301 Business Model Worldwide CC CC CiL a a KONFIDOTEILT Region/Saks Channel Comments LISA - Own sales organization Asia IC~onica Minolta & raphie Ine a a Lease & Pay per treatment Sold as stand-alone systems Sold as stand-alone systems - Own sales force in Sweden STOCKHOLM CORPORATE FINANCE EFTA01099302 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. • Taking over personnel who previously worked with scalp cooling enabled direct access to customers. - Standard contract: two year lease at 600-1,000 USD/month plus 175-350 USD/treatment. - Service agreement with Siemens. KONFIDENTIDAT STOCKHOLM CORPORATE FINANCE FDA News Reloaso FDA allows marketing of cooling cap to reduce hair loss during chemotherapy I ewe e a 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 Production in Sweden S: K CO S : : : %T r FIN V1 • 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. • Approx. 1.5 million new breast cancer patients are diagnosed worldwide each year. • The US market for scalp cooling is worth approx. $400 million/year. Approx. 235,000 new breast cancer patients are diagnosed per year in the United States, of which approx. 60% can use DigniCap. I lulliUSI HEALTHY LIVING The FDA Just Approved Something That Could Make Cancer More Bearable a Scalp Gaoling cops could PIO) breast cancer patients keep their hair. 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 60.older 100 anunelyeldrig Onto las reduce la Na erne thentalharrn R 2016 utnx !meta int Celt" talmens. KONF11111MEILT 14 EFTA01099309 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 STOCKHOLM CORPORATE FINANCE I5 EFTA01099310 Ranking of Chemotherapy Side-Effects • Among 36 who have been diagnosed with cancer Ranked lst 7.5% 5.6 — aS• 06 adon down by CA ono** DITIratild owrei. 16 Pus Lan neon Perbrilltif O. 666,6 60666 papa eints too ••• UMW, Allman Uksaza an.ao frint.n. red CrOterel mann ■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 110010I101:0111/010t Enormity inpalaill ■ SOSIONNIrrpalent EnomVy unrcutani Kopanownewr ■ 54ppµ,prpp.porrll 17 17 EFTA01099312 Dignitana Media Strategy NBC Nightly he‘. A Lt.:Tiers-- arect• - 47 ===r--r- • In addition the DigniCap-system has also been included in New York Times Science SION:i0ENTST Lehd•Ilikillt0.••••••••••••114144 OEM • S7 ( .KHO, ',1 CORPORATE FINA\CE CBS hlOining News 1.4114011. a Devic• May Spar* Hair Of Gamin' Moots mi... • immow•••• • •••• 1.1•••••• • • • • .N • l• • ••••• Soot •••••••ali••••••••••••••• gms•••m. Imams •.••••• •••••••••••• •••••m•••••• •••••• %sm. •••••••••••••••• ••••••••• •miamm •rws•••• I8 EFTA01099313 Agenda I . The Company and go to market strategy 2. The Market 3. Investment Case 4. Appendix KONFIDEN11ELLT STOCKHOLM CORPORATE FINANCE EFTA01099314 The people to execute the business plan Board Distnitana: Seamy Rig Born 1950 Chairman of the board since 2014 Others: Board member Xsivo Perfusion AB and Incentive AB. Fortner CEO of Axis and ProstaLund (holds 335 079 shire% in Me company) Jaen Stamby !km 1961 Chairman of Me boon! Burresund AB. major shareholder in Digniuna AB. Others: Member of Me boon! in Precella AB. Nartilus AB. Pere>: AB and Tochnovolais (holds 3 835 676 shams in the company) Erik won Seiwak Born 1964 VP Physio-Control Inc 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) nOtici 00 vriEly. t& una: Magnas Nilsson Born 1956 CEO X‘ivo Perfusion AB Others: CEO Virrolife AB and senior posirions at KaroBio and Phannacia & Upjohn AB Others: Chairman of the boordAridieare. member of the bord Xvitn Perfusion. Sensodeci All & Camera Makeeh AB. Former CEO Jobfe AB & lastm AB (holds 30 5S4 shares in the company) Bill Cronin Born 1961 COO Ommiana Im Others: Former CFO Direct Trading Instiumonal and Managing Director at Knight Capital Group. Founder Chan Cold Cap (bolds 1800 572 Mares in *re company) 20 EFTA01099315 The people to execute the business plan, cont. Xlarnament Divnitarta: Jan Abbate-son CEO Dioniuna An Born 1960 Others: Former VP Sales Nnicroun tinkling AB. Sales Director IlemoCue AB. Board member Phase tro)ographic Imaging, Moran Faxtighet, AB (holds 40547 shares and 1O1 OD warrants in the company) Tobias Frit. Born 1979 COO Dignitara AM in charge of productica. development Others: Master of Science. Lands University (holds 5016 shares and 10000 warrants in the company) KOKIO€TELLT Xlanasunent Dionimm: £r&a Bigeraan Born 1979 Clinical Affairs Director Dignitana All Others: Master of Science Biomedical Chemistry. PhD Experimental Oncology (holds 796$ shares and ID 000warrants in the company) Maelthrine Roos Born 1979 CVO Others: Matto; of Science Business Administration and Economics (holds 6416 shares and 10 000 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 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 about 10%-15% Other activities 5.10 MSEK Pro-money valuation: ILO MSEK Subscription once: Bock bulking Subscription period (prehrninaty): Second half of PO 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 Principle of Scalp Cooling Car r Reduced iemperanue Reduced blood few (Perfueron) • An Individual has an average of approximately 100,000 strands of hair 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 renew roe will inevitably be transported to the 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 cytosta icle. tic drugs, pass to the hair foll !roc, snob and ddinn Hair cell survival xcesterinewr 27 EFTA01099322 rip DIGNE6,N., EFTA01099323

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