Case File
efta-efta01099293DOJ Data Set 9OtherSTOCKHOLM
Date
Unknown
Source
DOJ Data Set 9
Reference
efta-efta01099293
Pages
31
Persons
0
Integrity
No Hash Available
Extracted Text (OCR)
Text extracted via OCR from the original document. May contain errors from the scanning process.
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
Technical Artifacts (2)
View in Artifacts BrowserEmail addresses, URLs, phone numbers, and other technical indicators extracted from this document.
Phone
1.4114011Wire Ref
referenceForum Discussions
This document was digitized, indexed, and cross-referenced with 1,400+ persons in the Epstein files. 100% free, ad-free, and independent.
Annotations powered by Hypothesis. Select any text on this page to annotate or highlight it.