Beruflich Dokumente
Kultur Dokumente
annual report
PART 1 AEROCRINE IN WORDS
k n o w l e d g e i n e v e r y b r e at h
Contents
Key figures
28
Aerocrine in brief
CEOs comments
7
89
1011
1214
1517
Aerocrine products
1819
2021
Aerocrines share
20
2527
Sustainability
2830
18
Future
reporting dates
First-quarter Interim Report:
12 May 8.00 AM
Annual General Meeting in Stockholm: 12 May 5.00 PM
Second-quarter Interim Report:
24 July 8.00 AM
Third-quarter Interim Report:
6 November 8.00 AM
Year-end report 2014:
19 February 2015 8.00 AM
93,498
72%
72%
69%
neg
neg
neg
27%
76%
29%
-0.73
-0.86
-2.09
Liquid ratio %
613%
392%
312%
133
107
71
3,320
5,468
6,108
75,127
75,511
53,198
25%
25%
27%
2224
Risk factors
Glossary
147,009
Gross margin %
136,168
25
Jan 1, 2011
Dec 31, 2011
Jan 1, 2012
Dec 31, 2012
45
Market overview
Jan 1, 2013
Dec 31, 2013
31
AEROCRINE IN BRIEF
Aerocrine in brief
Aerocrine AB (publ) sells medical technology products and tests used in healthcare to facilitate the
diagnosis, and improve the treatment and monitoring of patients with inflammation of the airways.
This allows physicians to apply the correct treatment or adjust on-going treatment if the patients
adherence is shown to be inadequate. In addition to enhanced quality of life for patients, this can
also entail major savings for society.
SWEDISH RESEARCH
These products are also used in research on respiratory diseases.
The method is based on Swedish research demonstrating that
raised levels of NO, nitric oxide, in exhaled air can be an indi
cator of inflammation in the airways. Aerocrine has developed
proprietary products that measure NO levels in exhaled air and
currently markets NIOX MINO and NIOX VERO in Europe,
small, handheld instruments, to physicians and healthcare units.
Aerocrines Vision
To improve the management of inflammatory
airway disease and the quality of patient lives
worldwide.
OWN PRODUCTS
NIOX MINO is sold worldwide. The US is currently the largest
market, with very rapid growth following the publication of
clinical guidelines in September 2011. Germany is currently the
largest market in Europe, with 80 percent of the countrys private
lung specialists as customers. The Companys most promising
markets are currently the US, alongside Japan and China.
Aerocrines Mission
To establish FeNO testing as part of the
standard of care in the management of
patients with inflammatory airway disease.
This will enable healthcare providers to
more effectively and efficiently diagnose
and manage patients, leading to a higher
quality of life and better clinical outcomes.
Aerocrine AB (Sweden)
Aerocrine Inc.
(US)
Aerocrine AG
(Germany)
Aerocrine Ltd
(UK)
Aerocrine
ESOP AB
CEOS COMMENTS
Many Achievements,
Challenging Financial Results
Aerocrine experienced growth in the US during 2013 which was one
of our main goals but our worldwide sales were flat year over year
which was not our expectation. We achieved a number of significant
milestones and continue to develop as a commercial organization.
We remain committed to creating a growing and valued company,
CEO of Aerocrine Scott Myers says.
from the field. We also introduced an enhanced device evaluation program and new
pricing models. During the fourth quarter,
we saw some disruption on the results due
to our sales leadership changes but we are
convinced that the positive effects of strengthened market expertise, a novel method for
clinicians to experience the value of NO and
strengthened sales management will help us
improve our execution and performance in
the US. It will take time to see the output from
our efforts.
The markets outside US were more or
less flat. In the EU, we did not see the
expected growth through our partnership
with Stallergenes in the key countries of
France and Italy.
CEOS COMMENTS
EXTENDED COLLABORATION
AND SUB-DISTRIBUTORS
In order to improve our commercial approach
in our RoW territories in a cost effective
manner, we extended the collaboration with
our Danish distributor, Intramedic AB. They
will now cover the Swedish market and
we are also evaluating if adding additional
distributors or amending our existing partnerships would improve our performance.
In China, we are now able to negotiate
directly with sub-distributors of our choosing
since Shanghai Pharma is no longer our exclusive importer. This will provide more flexibility
for us as we look to expand and diversify our
commercialization efforts in China. In 2014,
we will need to re-register our products in
China. We have taken over this process with
the help of new regulatory consultants.
The Aerocrine Global Strategic Account
sales are impacted by the size and timing of
clinical trials, which we do not control. As
Scott Myers
Solna, April, 2014
2013 in summary
Q1 2013
Q3 2013
Financial events
Financial events
Operational events
Operational events
Q2 2013
Q4 2013
Financial events
Financial events
Operational events
4 April Summons to AGM published.
4 April Georgia Medicaid program adds coverage for
Aerocrines FeNO testing in asthma management.
4 April NIOX MINO version 08 receives market
clearance in Japan.
10 April NIOX MINO version 09 receives market
clearance in Canada.
20 May Aerocrine Announces Presentation of Data
on FeNO testing in Overlap Syndrome at ATS 2013.
Operational events
11 October Swedish primary care trial supports
FeNO-guided asthma treatment is published.
8 November British National Institute for Health and
Care Excellence (NICE) publishes preliminary recom
mendations for the use of FeNO testing to help diagnose
and treat asthma.
25 November NIOX MINO version 09 receives market
clearance in Japan.
18 December Aerocrine enters into distribution agree
ment with Intramedic regarding the Swedish market.
For further information visit the Aerocrine homepage.
VD
MARKET
har
orde t OVERVIEW
CONTINUOUS BUSINESS
Aerocrines instrument includes a sensor that
analyzes the amount of nitric oxide in the
exhaled air. The instrument has a lifetime of
three years, corresponding to about 3,000
MARKET OVERVIEW
MARKET-LEADING
100
50
Q1-12
Q2-12
Q3-12
Q4-12
Q1-13
Q2-13
Q3-13
Q4-13
99
MARKET POTENTIAL
HEALTH ECONOMY
QUALITY OF LIFE
10
MARKET
Aerocrines pre-programmed
sensors secures recurrent
revenues.
RECURRING REVENUES
Consumption
INITIAL REVENUES
Product
RESEARCH,
DEVELOPMENT
Specialist physicians
Specialist physicians and allergy experts often meet the patients with the most
severe symptoms. Inflammation testing facilitates fast and correct diagnosis while
alleviating patient suffering. The impact of FeNO testing in Germany, where
more than 80 percent of pulmonary specialists use the method, is unique and the
Company is working actively to increase sales in the same way to specialist clinics
in several other markets. The potential is extensive in the US alone, there are some
8,000 specialist hospitals/clinics.
HEALTH ECONOMICS
AND QUALITY OF LIFE
FeNO testing is a preventive measure that
enhances the patients quality of life while
allowing considerable sums to be saved
in healthcare budgets. By means of continuous measurements, increased levels
of inflammation can be discerned and
the correct treatment can be prescribed.
In the US alone, direct and indirect costs
for asthma care total about SEK 50 billion.
If asthma is controlled well, the patients
suffering can be reduced tangibly. This
is beneficial in terms of social economy
since healthcare costs related to respiratory
diseases can be reduced.
Patients with respiratory problems often turn to outpatient and primary care clinics
first. For these clinics to have access to FeNO testing, the method must first be included
in the relevant countrys national guidelines for asthma treatment and there must be a
functioning system for cost reimbursement. One of the markets where these parameters
are beginning to fall into place is the US. There is a large and significant target group
here in the countrys approximately 80,000 primary care physicians.
Patients
A sensor with pre-
programmed number of
tests is the corner-stone
in the Companys business
model to charge per test.
A precondition for people with asthma to be able to monitor and treat their own
condition is that they be provided with their own equipment. Here, there is a clear
parallel with diabetes and blood sugar testing whereby diabetics have their own
instruments and can continuously monitor their condition and administer their insulin.
11
Actions taken to
strengthen our position
The clinical sales for Aerocrine Inc grew 21% (26% in local currency)
year over year. Key milestones were reached including an exit install
base of over 2,000 devices and cumulative test for clinical use for the
year of almost 612,000.
Publication
FeNO-guided
Number of patients
Asthma-attacks/year
Traditional
guidance
Number of patients
Asthma-attacks/year
Weight
Shaw 2007
Smith 2005
Powell 2011
Metaanalysis
52
46
111
209
0.33
0.49
0.288
0.32
51
48
109
208
0.42
0.9
0.615
0.59
29.4%
10.9%
59.7%
100%
By guiding the dose of corticosteroids based on a patients FeNO-value, the number of asthma attacks is reduced
by 40% compared to traditional methods. This is shown by a new meta-analysis on over 400 asthma patients.
Ref: Donohue , J.F. and N. Jain, Exhaled nitric oxid to predict corticosteroid responsiveness and reduce
a sthma exacerbation rates, Respiratory medicine, 2013.
12
A method
correlating to
inflammation
13
Thanks to regular measuring of airway inflammation with FeNO, patients with asthma can
be kept under better control. Studies also show
that FeNO can be very useful for doctors in
detecting patients who are not compliant to
their medication and as a guide regarding
choice of therapy.
14
Reimbursement
in the US market
Reimbursement for FENO-testing
has remained steady in the US
market for 2013.
Reimbursement by private insurance
companies as well as government
programs including Medicare and
Medicaid continue to cover more
than 60% of US lives.
Medicare, the first to cover 100
percent of its lives, has done so since
the introduction of FeNO-testing.
FeNO is covered under Medicaid in
36 states and the District of Columbia;
key additions in 2013 include Texas,
Georgia and Virginia Medicaid. As
managed Medicaid continues to grow
access should continue to increase.
The two largest private payers in the
US, United Healthcare and WellPoint,
continued to cover FeNO in 2013, as do
more than half of the Blue Cross Blue
Shield plans in the nation. BlueCross
BlueShield is a federation of 38 separate health insurance organizations and
companies around the United State.
marketing and promotion and KOL management to ensure continued high profile of
Aerocrine and FeNO.
The challenges of the Chinese market that
we experienced during quarters 2 and 3 of
2013 began to abate in the final quarter of the
year as hospitals across the country returned
to normal procurement operations and we
started to see a good uptake in placement of
NIOX MINO devices in new hospital accounts
as well as increased activity in existing sites.
Additionally we have signed new import and
distribution agreements to extend our coverage
of the Chinese market.
2013 also saw the launch of the new
NIOX VERO at the ERS Congress in Barcelona
in September. Sweden, UK and Germany
commenced handling and evaluation studies
of the NIOX VERO in Q4 with a variety of
key accounts in both primary and secondary
care settings. The first commercial sales of
the NIOX VERO were registered in the UK in
October which ensured that we ended 2013
on a high note with our first product launch
in 5 years a great success. Everyone at
Aerocrine is excited about the prospects for
the NIOX VERO as we continue the launch
programme globally in 2014.
REIMBURSEMENT IS A KEY
TO SUCCESS
One of the main obstacles in markets throughout Europe and Asia continues to be the lack
of payer acceptance in the form of reimbursement and lack of strong positive guidelines in
many countries.
It continues to be a challenge for the business and we work constantly at it. We have
made a number of positive steps in some key
markets in 2013 and we expect to see further
improvement in 2014 with the publication in
April of guidance on FeNO from the UKs
National Institute for Health and Clinical
Excellence (NICE) and later in the year the
German Federal Joint Committee of Physicians
and Insurers (GBA).
15
Market Updates
GERMANY
It was a challenging start to 2013 for Germany
with a large turnover of sales staff during
quarter 1 which did however allow us to
restructure and refocus with a new sales
organisation. Sales were subsequently behind
previous year in Q2 and Q3; however the
last quarter of the year showed a stabilisation
and good growth of the installed base and
demonstrated the potential of the new sales
team for 2014. An important success during
the year was the winning of a substantial
tender for an epidemiological study with
200,000 participants in which FeNO will
be measured and monitored using the new
NIOX VERO device. Aerocrine AG also
applied for reimbursement of FeNO at the
Gemeinsamer Bundesausschuss (German
Federal Joint Committee of Physicians and Insurers). In the initial investigation period of the
method the potential for FeNO has been identified and we will be working in 2014 towards
potential reimbursement along with continuing
engagement with the German guidelines.
UK
The United Kingdom saw excellent test-kit
growth in 2013 as a result of a concerted
effort to increase the installed customer base
across the secondary care hospital market. At
the same time considerable efforts were also
focused on raising the profile of FeNO and
Aerocrine within the primary care (GPs) and
pharmacy sectors. Further progress was also
made with the publication of the initial draft
CHINA
KOREA
JAPAN
After a long and extensive review by the
regulatory authority, PMDA in Japan, the
NIOX MINO -08 was approved for commercialization on the 28th of March. As this older
version device was a no longer manufactured
Aerocrine the impact of sales was limited.
As the NIOX MINO -08 had previously been
approved by the PMDA the current model
NIOX MINO -09 version was approved much
quicker and we received regulatory approval
in mid-November 2013. During this time the
Japanese distributor Chest M.I Inc., had built
up a substantial number of customer orders
16
SWITZERLAND
Switzerland has a favourable market for the
implementation of FeNO in the standard care
of asthma, especially in the patients followed
by pneumology and allergology. In 2013 the
Swiss market continued to develop in a positive manner. We are working closely with the
distributor in 2014 to extend reimbursement
to additional medical specialities.
SPAIN
Despite a severe financial crisis in Spain,
our distributor, Thermo Fisher managed to
increase sales in 2013 compared to 2012, a
great feat under the circumstances. Aerocrine,
keen to support such a pro-active partner,
focused on the training of the sales team
FRANCE
This was an important year to validate our
market access strategy in the French market.
With the low penetration and awareness of
FeNO in the secondary care segment we
understand that we need to increase the work
with the main university centres to position
FeNO measurement as key information in the
management of patients with inflammatory
airway diseases. During 2013 we have begun
building the foundations necessary to have
FeNO implemented in clinical guidelines
and in the clinical practice in several French
specialty centres.
BENELUX
The sales in the region started off with a very
good Q1, but lost momentum due to high
turnover of sales reps at the distributor. The
later part of the year showed some recovery,
following the focus to quickly rebuild a strong
sales team with active support by Aerocrine.
SWEDEN
During the year Aerocrine continued to
grow the market in the world with highest
penetration in terms of FeNO usage in primary
care. In December, an exclusive distribution
agreement was signed with Intramedic AB for
the sales and distribution of NIOX VERO in
Sweden. This is part of Aerocrines strategy of
substantially growing the European business
in a cost-efficient manner. We are maintaining a direct presence in the Swedish market
to support development of FeNO guidelines,
KOL (Key Opinion Leader) management and
engagement with payers.
DENMARK
There is a high FeNO awareness among
specialists in the region, and there is also
reimbursement for adult specialists, resulting
in virtually every hospital in the country using
FeNO routinely with many times several NIOX
MINO devices in each site. The main opportunity for the coming period is payer acceptance,
achieving reimbursement for pediatricians.
17
AEROCRINE PRODUCTS
18
CE labelling
Patents
The patent dispute between Aerocrine
and Belgian company Medisoft S.A. was
concluded in March 2013 and resulted in
a licence agreement between the parties
and entailed all patent suits between
them being dropped.
An important part of the development
strategy involves continuously applying
for new patents. As per 31 December
2013, the Companys broad patent
portfolio included 216 patents, divided
among 25 separate patent families.
These cover aspects including method,
design and critical technical functions.
Of 22 patents issued in the US, 15
have also been issued in key European
countries and 10 (9) in Japan. In the
Companys priority markets, it is the
basic and central aspects of respiratory
NO testing that are protected.
AEROCRINE PRODUCTS
Aerocrines method
Aerocrines discovery that exhaled
nitric oxide (FeNO) acts as a marker of
the underlying respiratory inflammation,
has resulted in a proactive method for
measuring the underlying inflammation
that causes asthma.
The more traditional diagnosis methods,
such as disease history, spirometry and
bronchial provocation, currently used in
accordance with guidelines on asthma,
have thus gained a valuable complement
in the shape of FeNO testing.
It is a quick and simple method that
provides valuable information on the
level of a patients airway inflammation.
Approximately 30 percent of patients
who are diagnosed with asthma, do not
have asthma when objectively assessed.
Compounding this problem is the fact that
of these patients incorrectly diagnosed
with asthma up to 70 percent of these
patients are receiving medications they
do not need or will respond to.
Testing of NO values using Aerocrines
instrument helps primary and secondary
care physicians provide the patient with
a more secure diagnosis. The test results
will provide the physician with information to a llow them to more a ppropriately
predict what medication the patient
with respond to their medication and
benefitted by it.
19
20
Inflammation or not?
1 FIRST ASSESSMENT
1)
Anti-inflammatory medication is
the basic treatment for asthma but
there are several other illnesses
besides allergic asthma that display similar symptoms. Untreated
allergic inflammation leads to an
increased risk of deterioration in,
and impaired, lung function.
A normal FeNO indicates
that no allergic inflammation is
present. This means that treatment
using steroids will not make any
difference.
A raised FeNO value
confirms an ongoing allergic
inflammation in the airways,
which is highly likely to be
reduced by treatment using
steroids. It is also likely that the
patient will respond to the
treatment, which is monitored
using FeNO.
2 MONITORING AND
2)
CONTROL
Symptom and lung function examinations alone cannot control
inflammation following treatment.
Continued measurement of the
FeNO value is a fundamental
prerequisite for having improved
control and management of the
FeNO normalized*
FeNO
not normalized*
Normal FeNO*
Consider:
Elevated FeNO**
Strong predictor
of allergic asthma
(or eosinophilic bronchitis)
ICS responsiveness likely
Inflammation
controlled
and patient
symptom-free
Inflammation
controlled
but patient
symptomatic
Consider:
Continue
theraphy
Morbidities
LTRA3 or LABA 2
add-on theraphy
Inflammation
not controlled
Address:
Adherence and
inhaler technique
Persistent allergen
exposure
Management and
control with FeNO
Consider:
FeNO level:
Anti-inflammatory medication:
HIGH
>50 ppb (adults)
>35 ppb (children)
MEDIUM
2550 ppb (adults)
2035 ppb (children)
LOW
<25 ppb (adults)
<20 ppb (children)
Oral corticosteroid
treatment
Anti-IgE treatment
*525 ppb for adults, 520 ppb for children <12 years
**above 25 (20) ppb
Based on group consensus cut-offs given in: Taylor DR, Pinjenburg MW, Smith AD, De Jongste JC. Thorax 2006;61:817-27
1)
21
AEROCRINES SHARE
SHARE STRUCTURE
There are 154,628,698 Aerocrine shares.
All shares have the same voting rights. The
shares have a quotient value of SEK 0.50.
OWNERSHIP STRUCTURE
There were around 5,000 (3,315) shareholders
in Aerocrine AB (publ) on 28 December
2013. The five largest shareholders accounted
for around 64.3 percent of voting rights and
capital. It is the Companys continued ambition to increase the spread of its ownership.
22
AEROCRINE HAS:
Sustainable and profitable business model.
Strong cooperation partner, Panasonic, which facilitates the development of
future products for outpatient care and for use directly in the home. Comparable
with diabetics and blood glucose testing, but with greater potential.
Strong owners who guarantee a long-term approach.
Strong and protected patent portfolio.
The method and Aerocrines products have achieved broad acceptance from
pharmaceutical companies and are used in almost all ongoing clinical studies
for the development of new asthma medicines.
The method is now included in clinical guidelines for the treatment of asthma
patients and in reimbursement systems, which is a fundamental prerequisite for
broader market penetration. Inflammation testing using FeNO is now included in
the guidelines issued by the American Thoracic society (ATS). The proportion of
US health insurance companies who reimburse physicians
for inflammation tests performed is increasing steadily.
New clinical data published that demonstrate improved
control at lower costs if treatment is guided using
FeNO testing.
FACTS IN BRIEF
Quoted on the stock exchange
since 2007
One share, one vote
Total number of outstanding
shares: 154,628,698
Ticker code: AERO
Market value on 30 December
2013: SEK 1,136.5 million
AEROCRINES SHARE
Shere price
SEK
15
5,000,000
12
4,000,000
3,000,000
2,000,000
1,000,000
0
Jan -13
Feb
March
April
May
June
July
Aug
Sept
Oct
Nov
Dec
Jan -14
Feb
March
Amount per
Dec 28, 2012
New
share issue
Amount per
Dec 30, 2013
Voting value
Share capital
Dec 30, 2013
B-shares
145,637,781
8,990,917
154,628,698
154,628,698
100.0
77,314,349:00
100.0
Total
145,637,781
8,990,917 154,628,698
154,628,698
100.0
77,314,349:00
100.0
Shareholders at the annual general meeting on 7 May, 2013 authorized the Board on one or more occasions
up to the next annual general meeting at the latest to issue new shares, warrants and convertible. The number
of shares, warrant or convertible bonds that can be issued shall not exceed a dilution of 10 percent. The quota
value amounts to SEK 0.50 per share.
Outstanding shares
currently and on full
conversion
Maturity
Number
20072016
959,732
1,158,259
0:50
20092018
180,232
200,304
0:50
155,987,261
20112021
9,382,430
9,888,395
0.50X*
165,875,656
Type
(Remaining)
154,628,698
155,786,957
SAP-2012
20122022
39,697
39,697
0.50
165,915,353
SAP-2013
20132023
50,807
50,807
0.50
165,966,160
*Redemption price varies between quotient value and market price at the time of allocation.
23
AEROCRINES SHARE
Total
number
of shares
Share
of capital
and votes
Novo A/S
Invifed AB c/o Investor
39,160,713
35,821,770
25.3%
23.2%
Health Cap*
Tredje A-P fonden
Avanza Pension Frskring AB
Handelsbanken fonder
Catella Sverige Select
Carnegie fonder (Luxemburg)
Founders
Others
17,032,835
4,233,324
3,183,926
2,570,235
2,316,000
2,275,000
508,443
47,526,452
11.0%
2.7%
2.1%
1.7%
1.5%
1.5%
0.3%
30.7%
Total
154,628,698
100.0%
Source: Euroclear
Convertible debenture
The convertible debenture issued in 2010 was
converted into shares in May 2012 in accordance
with the terms of the loan. The conversion entailed
a further 12,857,142 shares being issued.
Dividend policy
Proposals regarding dividends to shareholders will not
occur until sustainable profitability has been attained.
Accordingly, no dividends will be considered for the
coming years.
24
No of
A shares
No of
B shares
100,000
900,000
360 ,000
Date
Event
Nov 1997
Dec 1997
Dec 1997
Aug 1999
Aug 1999
Okt 1999
Jun 2000
Dec 2000
Jun 2001
Dec 2002
Jan 2003
Maj 2003
Formation of company
New share issue
Bonus issue
Reclassification
Directed share issue to
HealthCap and Investor
New share issue
New share issue
Reclassification
New share issue
New share issue
New share issue
Reclassification
Jun 2003
Aug 2003
Dec 2004
Jan 2005
Maj 2005
Aug 2005
Aug 2005
Jun 2006
Jun 2006
Maj 2007
Jun 2007
Dec 2008
9,000,000
45,968,236
20,523,669
2009
Sep 2010
Okt 2010
Nov 2010
Under 2010
Under 2011
Q1 2012
Maj 2012
Maj 2012
Q2 2012 I
Q2 2012 II
Q3 2012
Q4 2012
Q1 2013
Maj 2013
Q4 2013
Options subscribed
New share issue
New share issue
New share issue
Options subscribed
Options subscribed
Options subscribed
Conversion convertible bond
New share issue
Options subscribed
Options subscribed
Options subscribed
Options subscribed
Options subscribed
New share issue
Options subscribed
11,006
16,071,428
18,174,161
1,265,170
233,843
98,856
326,556
12,857,143
28,882,516
102,050
107,286
326,079
689,782
318,624
8,625,000
47,293
-100,000
No of
preference
shares)
Class P
100,000
1,600,000
P1
711,687
-30,693
1,732,414
1,526,142
171,454
-875
-2,430
2,013,508
378,030
3,196,436
4,000,000
999,457
4,000,000
1,304,348
4,000,000
1,304,348
P2
P2
P3
P4
P4
P2
P3
P1
P1
P1
P5
P5
P5
P5
P5
P5
288,451
30,693
3,305
3,020,262
567,045
4,794,654
-45,968,236
Total no of
shares
Quota value
per share,
SEK
Share
capital after
change, SEK
1,000,000
1,360 000
1,360,000
1,360,000
0.10
0.10
0.50
0.50
100,000
136,000
680,000
680,000
2,960,000
3,248,451
3,960,138
3,960,138
5,692,552
7,218,694
7,390,148
0.50
0.50
0.50
0.50
0.50
0.50
0.50
1,480,000
1,624,226
1,980,069
1,980,069
2,846,276
3,609,347
3,695,074
12,423,918
13,368,993
21,360,083
25,360,083
26,359,540
30,359,540
31,663,888
35,663,888
36,968,236
45,968,236
45,968,236
66,491,905
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
6,211,959
6,684,496:50
10,680,041:50
12,680,041:50
13,197,770
15,197,770
15,831,944
17,831,944
18,484,118
22,984,118
22,984,118
33,245,952:50
66,502,911
82,574,339
100,748,500
102,013,670
102,247,513
102,346,369
102,672,925
115,530,068
144,412,584
144,514,634
144,621,920
144,947,999
145,637,781
145,956,405
154,581,405
154,628,698
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
33,251,455:50
41,287,169:50
50,374,250
51,006,835
51,123,756:50
51,123,756:50
51,336,462:50
57,765,034
72,206,292
72,257,317
72,310,960
72,473,999:50
72,818,890:50
72,978,820:50
77,290,702:50
77,314,349:00
Subscrip
tion price,
SEK
70
25
25
50
70
23.33
23.33
10
10
10
10
10
10
11.50
10
11.50
25
4.25
0.50
7
7
7
0.50
0.50
0.50
8.75
9.00
0.50
8.20
0.50
0.50
0.50
11.00
0.50
RISK FACTORS
Risk factors
Aerocrines operations are subject to a number of risk factors that are
entirely or partly beyond the Companys control and that thus affect
or may come to affect the Companys operations, financial position
and/or earnings and consequently the value of shares. Described
below are the risk factors deemed to be of particular importance for
the future development of the Company.
25
RISK FACTORS
ECONOMIC CLIMATE
DELAYED LAUNCHES
Aerocrine is heavily dependent on a number
of key individuals. The possible loss of any of
these individuals could lead to the development or commercialisation of the Companys
products being delayed or diminished. Aerocrines capacity to retain and recruit qualified
employees is important in safeguarding the
level of competence within the Company.
Aerocrine has signed employment agreements
with key individuals on what it considers to
be market terms. Nonetheless, there is no
guarantee that the Company will be able to
retain these key individuals and the loss of
any of them could, in the short term, have
a negative impact on Aerocrines business,
earnings and financial position.
DEPENDENCY ON SUB
CONTRACTORS AND DISTRIBUTORS
Aerocrine is, and will remain, dependent
on collaboration with other players for the
manufacture of the Companys products.
If one or more of Aerocrines suppliers were
to discontinue its cooperation with the
Company, or if production disruptions, such
as delayed deliveries or issues of quality,
were to arise, that could cause problems
26
DISPUTES
PRODUCT LIABILITY
Aerocrines operations involve trials, marketing and sales of medical technology products,
which means that Aerocrine risks having
to remedy, compensate, recall or buy back
products that fail to work as intended. There
is a risk that Aerocrine, as the manufacturer,
be held responsible if a product were to cause
personal injury or damage to property. To
counteract this risk, Aerocrine holds product
liability insurance that, in the Companys
view, provides adequate insurance against
current product liability risks. New product
liability insurance policies are secured on
an ongoing basis and to the extent deemed
necessary. Despite this, there is no guarantee
that the Companys current or future insurance
cover will be sufficient for potential product
liability claims that may arise. Consequently,
it cannot be precluded that such claims may
impact Aerocrines business, earnings and
financial position negatively.
Because Aerocrines research and development, production and marketing are subject
to constant review by the authorities there
are no guarantees that the Companys current
permits will be renewed under the same terms
as before. Nor are there any guarantees that
such permits will not be revoked or limited.
Changes to legislation, insurance systems
or permit rules, problems discovered with a
product or at a manufacturer can therefore
negatively impact Aerocrines business, earnings and financial position.
NEW METHODS
COMPETITION
RISK FACTORS
CREDIT RISKS
When Aerocrine sells its products to customers, it incurs a risk of payment not being
made. Although the Group has guidelines to
ensure that sales are made to customers with
a suitable credit history, inadequate payment
capacity among customers could result in a
negative impact on the Companys operations,
earnings and financial position.
LIQUIDITY RISKS
Financial Risks
CURRENCY RISKS TRANSACTION
AND TRANSLATION EXPOSURE
TAX RISK
SIGNIFICANTLY
INFLUENTIAL OWNERS
27
SUSTAINABILITY
COMPLIANCE
During 2013, several serious cases of corruption were uncovered in the pharmaceuticals
industry, mainly in Asia. Aerocrine has not
been involved in any way, but the incidents
have nonetheless had negative effects on
Aerocrines sales. The explanation is that purchasers of medical equipment in certain markets have more or less halted all purchases for
fear of being accused of erroneous conduct.
With regard to Aerocrines external contacts, the company regulates anti-corruption
In this section, we account for how we are working towards more sustainable development the indicators we report find their inspiration in the Global Reporting Initiative
(GRI), internationally the most widespread format for sustainability reporting.
Corrugated
Electronics 30%
cardboard 23%
Metal 6%
Other 3%
Plastic 38%
28
SUSTAINABILITY
ENVIRONMENTALLY AWARE
PRODUCTION AND LOGISTICS
Aerocrines greatest environmental impact
occurs in the production and transportation
of its products, as well as in connection with
employees business trips. Efforts to manage
these environmental aspects are conducted
within the framework of Aerocrines environmental management system, which is largely
based on the methodology of the ISO 14001
standard.
preceding year.
29
SUSTAINABILITY
ATTRACTIVE EMPLOYER
All employees at Aerocrine have at least one
individual development interview per year at
which their performance and development
opportunities are reviewed. Personal training
Personnel turnover,
recruitments and departures
2013
Men
2012
Women
Men
14
20
48
20
Women
61
Sweden
UK
Switzerland
46
Overall, Aerocrine has an even balance between women and men. The background to
this is that we work actively on equality issues
within the framework of our equality plan.
Aerocrine seeks diversity and an even gender
distribution, since we believe this engenders
a more innovative and successful company
Instructor-led
training (hrs.)
22
Average, women
Women 45%
2013
2012
6
22
Men 55%
Absence due
to illness (%)
2013
2012
Gender
distribution 2013
Women
Men
Total
US
16
21
US
0.2
0.3
US
31
32
63
Sweden
Sweden
3.0
1.4
Sweden
18
26
44
Germany
1.7
3.4
Germany
Germany
UK
Switzerland
36
17
Number of newly recruited employees and the number of departing employees by gender and country.
Total personnel turnover is also presented, which also includes temporary employees.
30
Average, men
23
Germany
UK
2.8
2.6
UK
Switzerland
0.3
0.0
Switzerland
Average
1.3
0.9
Total
56
69
125
Glossary
ALLERGY
CHEMILUMINESCENCE
ANTI-INFLAMMATORY MEDICINE
Medication that suppresses inflammation;
generally some form of cortisone. Cortisone
is usually administered as an inhaled spray
used once or twice daily.
ASTHMA
Asthma is an inflammatory syndrome that
affects the airways. The symptoms are often
caused by a limitation of airflow (airway
obstruction), which is reversible, either
spontaneously or in response to treatment.
The obstruction is caused by contraction of
the airway muscles, as well as swelling and
increased production of mucus in the airways. Severity may vary from mild to life
threatening. Asthma is traditionally divided
into two types: allergic asthma and non-allergic asthma. Allergic asthma usually begins in
childhood, while non-allergic asthma is more
common in adults. However, there are also
other classifications.
CE-MARKED/CE CERTIFICATION
Regulations that ensure that a product is safe
and effective to use; a seal of quality and a
necessity for the use of medical devices in
routine practice.
CORTISONE
A vital steroid hormone produced by the
adrenal glands. Corticosteroids are widely
used anti-inflammatory medications.
Cortisone is used to relieve or stop allergic
reactions, but also for autoimmune inflammatory diseases such as rheumatism.
FDA
US Food & Drug Administration.
HEALTH ECONOMICS
Science that uses and develops economic
theory and economic analytical methods to
answer questions concerning human health.
The basic premise is that resources are limited
and in principle can be used in a variety of
ways. The problem is to choose among the
various alternatives so the money yields
maximum health, welfare and quality of life.
Health economics therefore serves as a basis
to provide guidance for policy decisions and
how to use and distribute limited resources.
INFLAMMATION
In a broad sense, the bodys defence against
injurious factors. Inflammation causes redness,
swelling, pain, local heat reaction and reduced
function. Redness and heat are caused by an
increase in blood flow to the inflamed area,
KOL
Key opinion leader.
COPD
Chronic Obstructive Pulmonary Disease.
MDD
EU Medical Device Directive.
NICE
National Institute for Health and Care
Excellence (UK).
NO
Nitric oxide, a gas.
REIMBURSEMENT
Reimbursement system, compensation from
healthcare authorities for tests performed.
RoHS
EU directive (Restriction of Hazardous
Substances Directive) aimed at ensuring
that all electronics products that are sold
are lead-free. The entire production process,
as well as materials and purchases, must be
adapted to meet the new production conditions. Since 1 July 2006 essentially all electronic products must comply with the RoHS
Directive in order to be sold at all in the EU;
however, exemptions may be granted.
STEROIDS
SPIROMETRY
Pulmonary function test based on measurement of exhaled air volume and air flow rate
during exhalation. Carried out using a special
gas volume measurement instrument known
as a spirometerr.
WEEE
The EU Waste Electrical and Electronic
Equipment Directive (WEEE) establishes
targets for collecting, recycling and reusing
electronic products in order to reduce
hazardous electronics waste. WEEE is linked
to the RoHS.
NIOX, NIOX MINO , NIOX VERO and Aerocrine are trademarks registrated by Aerocrine AB.
Aerocrine AB
Visiting address: Rsundavgen 18, Solna
P. O. Box 1024
171 71 Solna
Sweden
Phone: +46(0)8-629 07 80
Fax: +46(0)8-629 07 81
E-mail: info@aerocrine.com
Aerocrine Inc.
5151 McCrimmon Parkway
Suite 260
Morriisville, NC 27560
USA
Phone:: 1-866-275-6469
Fax: 1-866-630-6469
E-mail: info.US@aerocrine.com
sales.US@aerocrine.com
Aerocrine Ltd
The Tannery,
19 Kirkstall Road,
Leeds,
West Yorkshire, LS3 1HS
UK
Phone: +44 (0)845 548 1511
Fax: +44 (0)845 548 1512
E-mail:sales.uk@aerocrine.com
Aerocrine AG
Louisenstrae 21
61348
Bad Homburg
Germany
Phone: +49 6172 49560 0
Fax: +49 6172 683414
E-mail:Info@aerocrine.de
www.aerocrine.com www.nioxmino.com