QUARTERLY RELEASE FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022
Corporate Release No 728/2022
Financial report for the period January 1 to June 30, 2022
Lundbeck’s sales increased by +7% (+3% in local
currencies) to DKK 8,847 million in the first half of 2022
HIGHLIGHTS
Strategic brands are significant growth drivers of strong operational performance growing +27% (+19% in local
currencies) in the first half of 2022 representing 63% of overall revenue
• Brintellix
®
/Trintellix
®
: +24% reported to DKK 2,051 million (+17% in local currencies)
• Rexulti
®
/Rxulti
®
: +29% reported to DKK 1,771 million (+17% in local currencies)
• Abilify Maintena
®
: +16% reported to DKK 1,393 million (+11% in local currencies)
• Vyepti
®
: +120% reported to DKK 390 million (+100% in local currencies)
All markets contribute to revenue momentum
• United States: +12% reported to DKK 4,132 million (+1% in local currencies)
• International Markets: +13% reported to DKK 2,695 million (+6% in local currencies)
• Europe: +10% reported to DKK 2,066 million (+10% in local currencies)
Currency favorability nearly fully offset by negative hedging effects. Additional investments in marketing and sales
costs underpinning the launch of Vyepti in several markets during 2022. Core EBIT in addition impacted by lower
amortization of product rights and a lower usage of restructuring related provisions
• EBIT: +1% reported to DKK 1,497 million
• Core EBIT: -3% reported to DKK 2,073 million
• EPS: -9% reported to DKK 0.92
• Core EPS: +7% reported to DKK 1.652
Positive results of the phase III in the treatment of agitation in patients with Alzheimer's dementia
• In June 2022, Lundbeck and its partner Otsuka Pharmaceutical announced positive results of the phase
III clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia
• Demonstrated statistically significant difference (p=0.0026) in the mean change from baseline to Week 12
in the Cohen-Mansfield Agitation Inventory (CMAI) total score between brexpiprazole and placebo.
Statistical significance achieved in key secondary endpoints
• Regulatory filing to the FDA planned later in 2022
The Asia approval directed studies with eptinezumab, SUNRISE and SUNLIGHT, are on track. The small,
spearhead trial, SUNLIGHT, conceived as a potential accelerated path for migraine patients with MOH in China, did
not achieve statistical separation from placebo. The placebo effect in this study was greater than in prior
eptinezumab trials.
In connection with the financial report, Lundbeck’s President and CEO, Deborah Dunsire said:
“I am really pleased with the progress we are making in the business for the first half months of the year. Our
strategic brands continue to perform strongly across all markets and deliver robust growth. Vyepti uptake continues
and the efficacy profile is welcomed by severely impacted patients who have had inadequate response to other
therapies. The market roll out has continued with three market launches in first half and additional seven planned in
second half of the year. Our recent study read-out on brexpiprazole showed meaningful outcomes for people with
agitation in Alzheimer’s disease, a disease that has no approved treatment options available. We are now
progressing this indication forward for FDA approval. We look forward to the second half of the year, where we
continue to forge ahead implementing our Expand and Invest to Grow strategy.”
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 2
Corporate Release No 728/2022
2022 GUIDANCE
Guidance in reported currency for 2022 updated ahead of this quarterly release to account for strong organic
revenue momentum in strategic brands and appreciation of Lundbeck’s main currencies while considering
concurrent investment in acceleration and global launch of Vyepti
• Revenue expected at DKK 17.2 – 17.7 billion
• Core EBIT expected at DKK 3.8 – 4.1 billion
• EBIT expected at DKK 2.4 – 2.7 billion
Key figures:
1 For definition of the measures “Core Revenue”, “Core EBIT”, “Core EPS” and “Core EBIT-margin”, see note 4 Core reporting.
2 The calculation of EPS is based on a share denomination of DKK 1 as a result of the share split completed on June 8, 2022. Comparative figures have been restated to
reflect the change in trading unit from a nominal value of DKK 5 to DKK 1.
DKK million
H1 2022
H1 2021
Growth
Core Revenue
1
8,847
8,233
7%
Core EBIT
1
2,073
2,147
(3%)
Core EPS
1
,
2
1.65
1.54
7%
Core EBIT-margin
1
23.4%
26.1%
Reported Revenue
8,847
8,233
7%
Reported EBIT
1,497
1,478
1%
Reported EPS
2
0.92
1.01
(9%)
Reported EBIT-margin
16.9%
18.0%
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 3
Corporate Release No 728/2022
CONTENTS
FINANCIAL HIGHLIGHTS AND KEY FIGURES ..................................................4
MANAGEMENT REVIEW ..............................................................................5
Financial guidance and forward-looking statements .....................................5
Revenue ...............................................................................................6
Expenses and profit ............................................................................. 11
Cash flows .......................................................................................... 13
Financial position ................................................................................. 13
Lundbeck's development portfolio ........................................................... 14
Sustainability update ............................................................................ 18
General corporate matters .................................................................... 19
STATEMENT OF THE BOARD OF DIRECTORS AND THE REGISTERED EXECUTIVE
MANAGEMENT ........................................................................................ 22
CONDENSED FINANCIAL STATEMENTS ....................................................... 23
FINANCIAL CALENDAR 2022 ..................................................................... 31
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 4
Corporate Release No 728/2022
FINANCIAL HIGHLIGHTS AND KEY FIGURES
H1 2022
H1 2021
Q2 2022
Q2 2021
FY 2021
Financial highlights (DKK million)
Core revenue
8,847
8,233
4,475
3,960
16,299
Core profit from operations (core EBIT)
2,073
2,147
889
894
3,517
Reported revenue
8,847
8,233
4,475
3,960
16,299
Operating profit before depreciation and amortization
(EBITDA)
2,339
2,347
1,049
995
3,720
Reported profit from operations (EBIT)
1,497
1,478
622
596
2,010
Net financials, expenses
322
197
(25)
112
429
Profit before tax
1,175
1,281
647
484
1,581
Tax
258
282
142
106
263
Profit for the period
917
999
505
378
1,318
Equity
19,596
17,540
19,596
17,540
18,279
Assets
37,275
34,036
37,275
34,036
34,653
Cash flows from operating and investing activities (free cash
flow)
(516)
476
852
452
1,662
Purchase of property, plant and equipment, gross
143
144
87
82
410
Key figures
Core EBIT margin (%)
23.4
26.1
19.9
22.6
21.6
EBIT margin (%)
16.9
18.0
13.9
15.1
12.3
Return on equity (%)
4.8
5.8
2.7
2.2
7.5
Return on equity (%) – rolling four quarters
6.7
11.5
6.7
11.5
7.5
Return on capital invested (%) – rolling four quarters
7.4
9.9
7.4
9.9
7.9
Net debt/EBITDA (x) – rolling four quarters
1.2
0.9
1.2
0.9
0.9
Share data
Number of shares for the calculation of EPS (millions)
1
992.9
993.4
992.8
993.2
993.3
Number of shares for the calculation of DEPS (millions)
1
992.9
993.4
992.8
993.2
993.3
Earnings per share, basic (EPS) (DKK)
1
0.92
1.01
0.51
0.38
1.33
Earnings per share, diluted (DEPS) (DKK)
1
0.92
1.01
0.51
0.38
1.33
Other
Number of employees (FTE) – end of period
5,437
5,603
5,437
5,603
5,348
1 The calculation of EPS is based on a share denomination of DKK 1 as a result of the share split completed on June 8, 2022. Comparative figures have been restated,
to reflect the change in trading unit from a nominal value of DKK 5 to DKK 1.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 5
Corporate Release No 728/2022
MANAGEMENT REVIEW
Financial guidance and forward-looking statements
Financial guidance
DKK
FY 2021 actual
2022 guidance
Revenue
16,299 million
DKK 17.2 – 17.7 billion
EBITDA
3,720 million
DKK 4.2 – 4.5 billion
Core EBIT
3,517 million
DKK 3.8 – 4.1 billion
Profit from operations (EBIT)
2,010 million
DKK 2.4 – 2.7 billion
Lundbeck’s financial guidance for 2022 which was
raised on August 9, 2022 is maintained. Revenue will
be driven by the strong appreciation of the main
currencies and the continued growth of Abilify
Maintena, Brintellix/Trintellix, Rexulti/Rxulti and the
strong growth of Vyepti.
Lundbeck has foreign currency risk mainly in USD,
CNY and CAD. The financial guidance for 2022 is
based on the currencies by the end of the first half
year. The hedging rates for the main currencies, i.e.,
USD/DKK (6.40), CNY/DKK (0.99) and CAD/DKK
(4.98) and the financial guidance include an expected
hedging loss of approximately DKK 500 million
compared to a hedging gain of DKK 53 million for the
full year of 2021.
Based on the assumptions for product and
geographical mix, it is estimated that a 5% change of
the USD/DKK exchange rate will impact revenue by
around DKK 150 million.
The current positive impact on product revenue from
the appreciating currencies is partly offset by the
negative hedging effect which is recognized in total
revenue.
Lundbeck plans to launch Vyepti in around eight
markets during the remaining part of 2022 including
the first markets in EU. Therefore, SG&A is expected
to increase over the coming quarters.
The Russian war against Ukraine has had limited
impact on Lundbeck’s financial results for the first half
of 2022. Lundbeck has ceased new investments and
further spend in clinical trials as well as diminished
promotional activities in Russia. The situation has
increased general uncertainty and Lundbeck
continues to monitor any potential impact on an
ongoing basis.
The A- and B-share structure
In order to ensure increased financial capacity, a new
share structure has been implemented after which
each of Lundbeck’s shares was split into one (1) A-
share carrying ten votes and four (4) B-shares each
carrying one vote. The A-shares and the B-shares are
ordinary, fully paid shares carrying equal economic
rights in all respects.
In connection with the split of Lundbeck’s existing
shares into A-shares and B-shares completed in June
2022, the Lundbeck Foundation (via its fully owned
subsidiary Lundbeckfond Invest A/S) offered eligible
shareholders a 1:1 exchange of their A-shares with
the Lundbeck Foundation’s B-shares.
Following the completion of the exchange offer, the
Foundation now holds approximately 80% of the A-
shares and approximately 66% of the B-shares. The
total share capital held by the Foundation is
approximately 69% and the total voting rights held by
the Foundation in Lundbeck is approximately 76%.
Forward-looking statements
Forward-looking statements are subject to risks,
uncertainties, and inaccurate assumptions. This may
cause actual results to differ materially from
expectations. Various factors may affect future
results, including interest rates and exchange rate
fluctuations, delay or failure of development projects,
production problems, unexpected contract breaches
or terminations, governance-mandated or market-
driven price decreases for products, introduction of
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 6
Corporate Release No 728/2022
competing products, Lundbeck’s ability to
successfully market both new and existing products,
exposure to product liability and other lawsuits,
changes in reimbursement rules and governmental
laws, and unexpected growth in expenses.
Revenue
Revenue reached DKK 8,847 million in the first half
of 2022 compared to DKK 8,233 million in the first half
of 2021, representing a growth of 3% in local
currencies (7% reported). Adjusted for Northera, the
growth reached 6% and 10%, respectively. The
strategic brands (Abilify Maintena, Brintellix/Trintellix,
Rexulti/Rxulti and Vyepti) grew 27% (19% in local
currencies) and reached DKK 5,605 million or 63% of
total revenue. Lundbeck’s biggest markets for the
strategic brands are the U.S., Canada, Spain, Italy
and Australia.
The growth in total sales is primarily due to strong
growth of the strategic brands and appreciation of
main currencies which to some extent has been
countered by the negative effect from hedging.
Lundbeck’s biggest markets are the U.S., China,
Canada, Italy, Spain and Japan.
Hedging
Lundbeck hedges a significant part of the currency
risk for a period of 12 - 18 months. Hedging had a
negative impact of DKK 202 million for the first half of
2022, compared to a positive impact of DKK 102
million for the first half of 2021.
Revenue - products and regions
DKK million
H1
2022
H1
2021
Growth
Growth in local
currencies
Q2
2022
Q2
2021
Growth
Growth in local
currencies
Q1
2022
Brintellix/Trintellix
2,051
1,656
24%
17%
1,061
852
25%
17%
990
Rexulti
1,771
1,378
29%
17%
940
706
33%
19%
831
Abilify Maintena
1,393
1,197
16%
11%
716
613
17%
11%
677
Vyepti
390
177
120%
100%
220
101
118%
95%
170
Cipralex/Lexapro
1,254
1,235
2%
(1%)
572
569
1%
(2%)
682
Sabril
322
336
(4%)
(13%)
170
169
1%
(11%)
152
Onfi
209
285
(27%)
(34%)
127
139
(9%)
(18%)
82
Other pharmaceuticals
1,503
1,714
(12%)
(17%)
691
705
(2%)
(7%)
812
Other revenue
156
153
2%
1%
91
72
26%
25%
65
Effects from hedging
(202)
102
(113)
34
(89)
Total revenue
8,847
8,233
7%
3%
4,475
3,960
13%
8%
4,372
United States
4,132
3,705
12%
1%
2,214
1,758
26%
13%
1,918
International Markets
2,695
2,387
13%
6%
1,239
1,131
10%
2%
1,456
Europe
2,066
1,886
10%
10%
1,044
965
8%
9%
1,022
Products
Brintellix/Trintellix (vortioxetine) is Lundbeck’s
largest product and is approved for the treatment of
major depressive disorder (MDD). Sales grew 17% in
local currencies (24% reported) and reached DKK
2,051 million following continued strong demand in
markets outside the U.S. The regional distribution of
sales was 36%, 33% and 31% in the U.S.,
International Markets and Europe, respectively. The
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 7
Corporate Release No 728/2022
largest markets for the product are the U.S., Canada,
Spain, Italy and China.
Rexulti/Rxulti (brexpiprazole) is Lundbeck’s second
largest product and is approved as an adjunctive
therapy for the treatment of adults with MDD and as
a treatment for adults with schizophrenia in markets
such as the U.S., Canada and Saudi Arabia. In
Australia and Europe, the product is approved for
schizophrenia. Lundbeck’s share of revenue reached
DKK 1,771 million for the first half of 2022
representing a growth of 17% in local currencies
(29% reported). The regional distribution of sales was
93%, 6% and 1% in the U.S., International Markets
and Europe, respectively. The largest markets are the
U.S., Canada, Brazil, Australia and Mexico.
Abilify Maintena (aripiprazole once-monthly
injection) is approved for the treatment of
schizophrenia in the EU and for both schizophrenia
and bipolar I disorder in the U.S., Canada and
Australia. Sales reached DKK 1,393 million
representing a growth of 11% in local currencies
(16% reported). The regional distribution of sales was
35%, 18% and 47% in the U.S., International Markets
and Europe, respectively. The largest markets are the
U.S., Spain, Canada, Australia and Italy.
Vyepti (eptinezumab) is approved in around 40
markets including the U.S., Australia, Canada and
Europe for the preventive treatment of migraine in
adults. The product doubled in sales and reached
sales of DKK 390 million in the first half of 2022
mainly following strong demand. Vyepti was
launched in April 2020 in the U.S. and it has since
been launched in Australia, Kuwait, Singapore,
Switzerland and U.A.E. During 2022, Vyepti is
expected to be launched in around 10 markets
including the first countries in the EU.
Cipralex
®
/Lexapro
®
(escitalopram) is approved for
the treatment of MDD. Sales reached DKK 1,254
million. The regional distribution of sales was 73%
and 27% in International Markets and Europe,
respectively. The largest markets are Japan, China,
South Korea, Italy and Brazil.
Revenue from Other pharmaceuticals, which
comprise the remainder of Lundbeck’s products,
reached DKK 1,503 million compared to DKK 1,714
million in the first half of 2021 following lower sales of
mature products such as Northera. Northera lost
exclusivity in February 2021 and is now reported
together with Other pharmaceuticals. Sales of
Northera reached DKK 237 million compared to DKK
439 million in the first half of 2021. The largest
markets for Other pharmaceuticals are China, the
U.S., France, South Korea and Mexico.
Other revenue, which mainly consists of contract
manufacturing, reached DKK 156 million compared
to DKK 153 million in the first half of 2021.
Figure 1 – Revenue per region H1 2022 vs H1 2021 (excluding Other revenue and Effects from hedging)
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 8
Corporate Release No 728/2022
Key developments in the second quarter of 2022
In the second quarter of 2022, revenue reached DKK
4,475 million compared to DKK 3,960 million in 2021.
The strategic brands grew by 19% in local currencies
(29% reported) for the period, thereby reaching DKK
2,937 million or 66% of total revenue. Other revenue
is positively impacted by quarterly fluctuations.
United States
Revenue reached DKK 4,132 million in the first half
of 2022 compared to DKK 3,705 million for the same
period in 2021. The strategic brands increased by
17% in local currency (29% reported) and reached
DKK 3,263 million or 79% of sales. The sales growth
was significantly impacted by strong demand but also
appreciation of the USD.
Revenue – United States
DKK million
H1
2022
H1
2021
Growth
Growth in local
currencies
Q2
2022
Q2
2021
Growth
Growth in local
currencies
Q1
2022
Rexulti
1,653
1,294
28%
16%
879
658
34%
19%
774
Trintellix
736
657
12%
1%
387
340
14%
1%
349
Abilify Maintena
487
398
22%
11%
255
202
26%
13%
232
Vyepti
387
177
119%
98%
220
101
118%
95%
167
Sabril
322
336
(4%)
(13%)
170
169
1%
(11%)
152
Onfi
209
285
(27%)
(34%)
127
139
(9%)
(18%)
82
Other pharmaceuticals
338
558
(39%)
(45%)
176
149
18%
8%
162
Total revenue
4,132
3,705
12%
1%
2,214
1,758
26%
13%
1,918
Products
Lundbeck’s share of Rexulti revenue reached DKK
1,653 million following a growth of 16% in local
currency (28% reported). Rexulti has a stable volume
market share of 2.2% by April 2022 (source: IQVIA).
Patient data suggest that more than 3/4 of
prescriptions are for major depression (MDD). In
December 2021, the U.S. Food and Drug
Administration (FDA) approved the supplemental
new drug application (sNDA) of Rexulti for the
treatment of schizophrenia in pediatric patients 13 to
17 years of age.
Trintellix sales reached DKK 736 million in revenue
for Lundbeck representing a growth of 1% in local
currency (12% reported). The MDD market in the US
is recovering after the pandemic but total NBRx in the
market remains lower than pre-COVID-19 but is
improving. The volume market share has been stable
around 0.8% by April 2022 (source: IQVIA). The
value market share of the total anti-depressant
market has increased from 24.2% by January 2021
to 26.0% by April 2022 (source: IQVIA).
Abilify Maintena revenue reached DKK 487 million,
representing Lundbeck’s share of total net sales.
Abilify Maintena has a stable volume market share of
around 23% by April 2022 (source: IQVIA).
Vyepti was approved by the U.S. Food and Drug
Administration (FDA) on February 21, 2020, for the
preventive treatment of migraine in adults. The
product was made available on April 6, 2020 and
reached a doubling of sales to DKK 387 million in the
first half of 2022 compared to the first half of 2021.
Sabril
®
is stable and reached DKK 322 million and
Onfi
®
revenue reached DKK 209 million. In Other
pharmaceuticals, Northera sales reached DKK 237
million for the period compared to DKK 439 million
last year following the launch of several generic
versions in February 2021.
Key developments in the second quarter of 2022
In the second quarter of 2022, revenue reached DKK
2,214 million compared to DKK 1,758 million last
year. The strategic brands grew by 34% (19% in local
currencies) for the period thereby reaching DKK
1,741 million or 79% of total revenue. The quarter
benefitted from 37% growth of Northera due to
stocking.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 9
Corporate Release No 728/2022
International Markets
Revenue from International Markets, which now also
includes Canada (see note 1 Accounting policies)
and therefore comprises all Lundbeck’s markets
outside of Europe and the U.S., reached DKK 2,695
million in the first half of 2022. The growth of 6% in
local currencies (13% reported) was mainly driven by
Rexulti and Brintellix. The biggest markets are China,
Canada, Japan, Brazil and Australia. China and
Japan constitute approximately 34% of regional
revenue. The strategic brands increased by 26% in
local currencies (35% reported) and reached DKK
1,035 million or 38% of sales.
Revenue – International Markets
DKK million
H1
2022
H1
2021
Growth
Growth in local
currencies
Q2
2022
Q2
2021
Growth
Growth in local
currencies
Q1
2022
Brintellix
685
483
42%
32%
345
246
40%
30%
340
Abilify Maintena
249
211
18%
11%
131
111
18%
10%
118
Rexulti
98
73
34%
25%
52
42
24%
14%
46
Vyepti
3
-
-
-
-
-
-
-
3
Cipralex/Lexapro
917
899
2%
(2%)
406
395
3%
(2%)
511
Other pharmaceuticals
743
721
3%
(5%)
305
337
(9%)
(16%)
438
Total revenue
2,695
2,387
13%
6%
1,239
1,131
10%
2%
1,456
Products
Brintellix/Trintellix reached DKK 685 million in
revenue or an increase of 32% in local currencies
(42% reported). Brintellix realized solid growth across
several markets including China, Canada, Brazil and
Japan, but the growth is also impacted by quarterly
fluctuations. Canada, China, Brazil, Japan and South
Korea are the largest markets for Brintellix in the
region. In Japan, Trintellix is showing a strong
momentum and has reached a volume and value
market share of 6.7% and 8.0%, respectively by June
2022 (source: IQVIA). Measured by volume market
share, it is the highest market share achieved by the
product in the main markets at this point of the
launch. Brintellix is not included in the National
Reimbursement Drug List (NRDL) in China and is not
reimbursed.
Abilify Maintena reached DKK 249 million in
revenue representing a growth of 11% in local
currencies (18% reported). Sales are mainly derived
from Australia and Canada, where Abilify Maintena
shows robust sales performance in spite of
pandemic-related restrictions last year. In Australia,
the volume share has reached 30.4% and in Canada,
it has reached 33.8% by April 2022 (source: IQVIA).
Countries such as Malaysia, Saudi Arabia and United
Arab Emirates (U.A.E.) also contributed positively.
Rexulti reached DKK 98 million in sales and grew by
25% in local currencies. In International Markets, the
product has its highest sales in Canada followed by
Brazil and Australia. In Canada, Rexulti has
increased its market share to 3.4% by April 2022
compared to 2.6% in April 2021 (source: IQVIA). In
Australia, Rexulti has maintained a market share of
around 2.2% in volume by April 2022 (source: IQVIA).
In Brazil, Rexulti has reached a volume share of 1.8%
compared to 0.9% by January 2021 (source: IQVIA)
and most of the product growth in the region came
from Brazil during the period.
Vyepti was introduced in U.A.E. and in Kuwait in the
second half of 2021. In the beginning of 2022, Vyepti
has been launched in Singapore and Australia.
Additional launches are planned for 2022. Revenue
for these markets will be booked when shipped and
quarterly variations will occur especially in the
beginning of the roll-out.
Cipralex/Lexapro generated revenue of DKK 917
million representing a growth of 2% (down 2% in local
currencies). Japan, China, South Korea, Brazil and
Canada are the largest markets for Cipralex/Lexapro
in the region.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 10
Corporate Release No 728/2022
Other pharmaceuticals generated revenue of DKK
743 million. Azilect is promoted by Lundbeck in some
countries in Asia. Azilect generated revenue of DKK
111 million while Ebixa generated revenue of DKK
218 million.
Key developments in the second quarter of 2022
In the second quarter of 2022, revenue increased
10% (2% in local currencies) and reached DKK 1,239
million. The strategic brands grew by 32% (23% in
local currencies) for the period, thereby reaching DKK
528 million or 43% of total revenue.
Europe
Revenue reached DKK 2,066 million in the first half
of 2022 compared to DKK 1,886 million in 2021. In
general, Europe continues to realize robust
underlying demand countering a continuous negative
average price development and continued generic
erosion on the mature product portfolio. The strategic
brands increased by 17% both reported and in local
currencies and reached DKK 1,307 million or 63% of
sales. The largest markets in Europe are Spain, Italy,
France, Switzerland and the UK.
Revenue – Europe
DKK million
H1
2022
H1
2021
Growth
Growth in local
currencies
Q2
2022
Q2
2021
Growth
Growth in local
currencies
Q1
2022
Abilify Maintena
657
588
12%
11%
330
300
10%
9%
327
Brintellix
630
516
22%
22%
329
266
24%
24%
301
Rexulti/Rxulti
20
11
82%
73%
9
6
50%
50%
11
Cipralex
337
336
0%
4%
166
174
(5%)
(2%)
171
Other pharmaceuticals
422
435
(3%)
(2%)
210
219
(4%)
(3%)
212
Total revenue
2,066
1,886
10%
10%
1,044
965
8%
9%
1,022
Products
Abilify Maintena is Lundbeck’s largest product in the
region. Sales uptake of Abilify Maintena is robust with
revenue reaching DKK 657 million, a growth of 11%
in local currencies compared to first half of 2021. In
Europe, the penetration of long-acting atypical
antipsychotics is generally higher than seen in the
U.S. (volume). Driven by increasing demand from
patients, sales of Abilify Maintena are growing across
Europe. The market share is still increasing in some
markets and the product has achieved 25% or more
market share (volume) in most markets (source:
IQVIA). In some markets including Italy and
Switzerland, the volume market share in April 2022 is
approaching or has exceeded 35% (source: IQVIA).
Abilify Maintena is the second most prescribed long-
acting injectable treatment for patients with
schizophrenia in many markets. Spain, Italy and
France are the largest European markets for Abilify
Maintena.
Brintellix revenue grew 22% reaching DKK 630
million. Brintellix is Lundbeck’s second largest
product in Europe and realized solid growth across
many markets. In main countries, Spain, Italy and
France, the product has increased value market
shares to 12.4%, 10.7% and 11.4%, respectively by
April 2022 (source: IQVIA). The volume shares have
increased to around 4.4%, 4.2% and 3.7%,
respectively (source: IQVIA).
Rexulti/Rxulti revenue reached DKK 20 million
following a growth of 73% in local currencies. The
product was launched in Italy in 2021 where it has a
volume share of around 0.7% by April 2022 (source:
IQVIA). Rexulti/Rxulti is in most markets co-promoted
with Otsuka Pharmaceuticals.
Vyepti was granted marketing authorization in the
European Union (EU) in January 2022 for the
prophylactic treatment of migraine in adults who have
at least four migraine days per month. The marketing
authorization is valid in all EU Member States,
Iceland, Norway and Liechtenstein. The formal EU
approval means that the milestone for the Contingent
Value Rights (CVRs) of USD 2 per share relating to
the acquisition of Alder BioPharmaceuticals, Inc. in
2019 was met. The amount payable by Lundbeck to
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 11
Corporate Release No 728/2022
the CVR holders was totaling approximately USD 230
million (DKK ~1.5 billion) and was paid in the first
quarter of 2022. Additionally, Vyepti is now approved
and launched in Switzerland. Lundbeck plans to
launch in some markets in EU in 2022 and many
more markets from 2023 and onwards following
pricing and market access discussions in each
market.
Cipralex generated revenue of DKK 337 million. The
product has been resilient and sees good growth but
is also positively impacted by quarterly fluctuations
and stock build-up in selected markets.
Revenue from Other pharmaceuticals was DKK
422 million, a decline of 2% in local currencies
compared to 2021, as a result of continued generic
erosion of mature products.
Key developments in the second quarter of 2022
In the second quarter of 2022, revenue increased by
8% (9% in local currencies) and reached DKK 1,044
million compared to DKK 965 million for the same
period in 2021. The strategic brands grew by 17% for
the period, thereby reaching DKK 668 million or 64%
of total revenue. Spain and Italy are key drivers of
growth and especially Brintellix benefits from
continued strong growth in these markets.
Expenses and profit
In the first half of 2022, total costs increased by 9%
to DKK 7,350 million compared to DKK 6,755 million
for the same period in 2021 as a consequence of
increased sales and appreciation of main currencies.
Distribution of costs
DKK million
H1 2022
H1 2021
Growth
Q2 2022
Q2 2021
Growth
Q1 2022
Cost of sales
1,811
1,797
1%
966
851
14%
845
COS-ratio
20.5%
21.8%
21.6%
21.5%
19.3%
Sales and distribution costs
3,087
2,712
14%
1,652
1,394
19%
1,435
S&D-ratio
34.9%
32.9%
36.9%
35.2%
32.8%
Administrative expenses
509
425
20%
273
215
27%
236
G&A-ratio
5.8%
5.2%
6.1%
5.4%
5.4%
Research & development costs
1,943
1,821
7%
962
904
6%
981
R&D-ratio
22.0%
22.1%
21.5%
22.8%
22.4%
Total costs
7,350
6,755
9%
3,853
3,364
15%
3,497
Cost of sales increased by 1% to DKK 1,811 million
in the first half of 2022 and the gross margin was
79.5% compared to 78.2% for the same period in
2021 benefitting from FX appreciation. Cost of sales
was furthermore positively impacted by the loss of
exclusivity on Northera, as the asset was fully
depreciated during the first quarter of 2021, and, also
by reduced royalty costs. Part of cost of sales relates
to amortization of product rights which was DKK 624
million for the period compared to DKK 669 million for
the same period in 2021. Core gross margin
increased from 86.3% to 86.6%.
Sales and distribution costs were DKK 3,087
million in the first half of 2022, an increase of 14%
compared to the same period in 2021 as the activity
level in general is increasing especially for Vyepti
launch preparation. Sales and distribution costs
corresponded to 34.9% of revenue in the first half of
2022, compared to 32.9% for the same period in
2021.
Administrative expenses compared to 2021
increased by 20% to DKK 509 million, corresponding
to 5.8% of total revenue. The increase is mainly a
result of cloud-based software that as of 2021 is
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 12
Corporate Release No 728/2022
recognized directly in the income statement and a
donation to Red Cross.
SG&A costs were DKK 3,596 million in the first half
of 2022 compared to DKK 3,137 million the same
period in 2021. The SG&A ratio was 40.6%,
compared to 38.1% in 2021 as activities were
increased with the lifting of pandemic restrictions.
Research & development costs were DKK 1,943
million in the first half of 2022 with an R&D ratio of
22.0%. Compared to 2021, the R&D costs increased
7% mainly driven by the initiation of phase II studies.
Total operational costs (OPEX) reached DKK 5,539
million in the first half of 2022 compared to DKK 4,958
million the same period in 2021.
Key developments in the second quarter of 2022
In the second quarter of 2022, total costs amounted
to DKK 3,853 million, representing an increase of
15% compared to 2021, partly due to appreciating
currencies and increased activity level. Core gross
margin declined from 86.0% to 85.5% due to higher
production costs.
Depreciation, amortization and impairment
losses
Depreciation, amortization and impairment losses,
which are included in the individual expense
categories, amounted to DKK 842 million in the first
half of 2022 compared to DKK 869 million in 2021.
Amortization of product rights was DKK 624 million in
the first half of 2022 compared to DKK 669 million in
2021.
Depreciation, amortization and impairment charges
DKK million
H1 2022
H1 2021
Growth
Q2 2022
Q2 2021
Growth
Q1 2022
Cost of sales
741
763
(3%)
373
345
8%
368
Sales and distribution cost
47
47
0%
24
24
0%
23
Administrative expenses
8
11
(27%)
4
6
(33%)
4
Research & development costs
46
48
(4%)
26
24
8%
20
Total depreciation, amortization
and impairment charges
842
869
(3%)
427
399
7%
415
Profit from operations (EBIT and core EBIT)
Reported EBIT grew by 1% thereby reaching DKK
1,497 million in the first half of 2022. The EBIT
margin reached 16.9% for the period compared to
18.0% the same period in 2021. Core EBIT declined
by 3% to DKK 2,073 million compared to the same
period in 2021 and Core EBIT margin was 23.4%.
This development should be seen in the light of the
expected increasing activity level following the
waning COVID-19 restrictions.
In the second quarter of 2022, EBIT reached DKK
622 million and Core EBIT reached DKK 889 million.
The Core EBIT margin declined from 22.6% to
19.9%.
For definitions of the measures “Core Revenue”,
“Core EBIT”, “Core EPS” and “Core EBIT margin”,
see note 4 Core reporting.
Net financials, expenses
Lundbeck generated a net financial expense of DKK
322 million for the first half of 2022, compared to a net
financial expense of DKK 197 million for the first half
of 2021.
The expenses are primarily derived from the fair
value adjustments on contingent consideration for the
European Medicines Agency’s (EMA) approval of
Vyepti amounting to DKK 319 million, along with
interest costs on the debt portfolio (including interest
rate swaps), and banking costs.
Tax
The effective tax rate for the first half of 2022 was
22.0%. The tax rate was negatively impacted by the
non-deductible CVR payment regarding Vyepti EMA
approval but offset by the Danish research &
development incentive.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 13
Corporate Release No 728/2022
Profit and EPS
Profit reached DKK 917 million for the first half of
2022 compared to DKK 999 million in 2021, due to a
more normalized activity level following the
pandemic. The reported net profit corresponded to an
EPS of DKK 0.92 versus an EPS of DKK 1.01 in 2021.
Core EPS reached DKK 1.65 in the first half of 2022,
compared to a Core EPS of DKK 1.54 in 2021. Please
note that the calculation of EPS is based on a share
denomination of DKK 1 as a result of the share split
completed on June 8, 2022. Comparative figures
have been restated to reflect the change in trading
unit from a nominal value of DKK 5 to DKK 1.
Cash flows
Cash flows from operating activities amounted to
an inflow of DKK 711 million in the first half of 2022
compared to an inflow of DKK 670 million in the first
half of 2021. The development compared to 2021 is
impacted by the realized financial expense in
connection with the payment of the contingent
consideration for the EMA approval of Vyepti. The
EMA approval of Vyepti triggered a payment to
former Alder shareholders of USD 2 per share. This
resulted in a payment of DKK 1,566 million,
consisting of DKK 490 million in operating activities
and DKK 1,076 million in investing activities.
Lundbeck’s net cash flows from investing
activities were an outflow of DKK 1,227 million in the
first half of 2022 compared to an outflow of DKK 194
million in the first half of 2021. In 2022, the cash flow
was driven by the payment of contingent
consideration related to the EMA approval of Vyepti.
The cash flows from financing activities were an
inflow of DKK 480 million in the first half of 2022
compared to an outflow of DKK 2,723 million in the
first half of 2021. The cash inflow mainly related to the
drawing on the RCF needed for the payment
triggered by the EMA approval of Vyepti.
In the first half of 2022, the net cash outflow reached
DKK 36 million compared to an outflow of DKK 2,247
million in 2021 which included repayment of DKK 2.0
billion loan. The net cash flow in 2022 is impacted by
the EMA approval of Vyepti and the dividend payout
of DKK 397 million which was approved at the Annual
General Meeting in March 2022.
Selected cash flow figures
DKK million
H1 2022
H1 2021
Q2 2022
Q2 2021
Profit from operations (EBIT)
1,497
1,478
622
596
Cash flows from operating activities
711
670
916
562
Cash flows from investing activities
(1,227)
(194)
(64)
(110)
Cash flows from operating and investing
activities (free cash flow)
(516)
476
852
452
Cash flows from financing activities
480
(2,723)
(189)
(420)
Net cash flow for the period
(36)
(2,247)
663
32
Financial position
At June 30, 2022, Lundbeck’s total assets amounted
to DKK 37,275 million compared to DKK 34,653
million at the end of 2021.
At June 30, 2022, Lundbeck's equity amounted to
DKK 19,596 million, corresponding to an equity ratio
of 52.6% compared to 52.7% at the end of 2021.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 14
Corporate Release No 728/2022
Net debt has increased from DKK 4,239 million at the
end of first half 2021 to DKK 4,287 million at June 30,
2022. Interest bearing debt was DKK 6,585 million
at the end of the first half of 2022 compared to DKK
5,930 million at the end of the first half of 2021.
Selected balance sheet figures
Lundbeck's development portfolio
Lundbeck is developing several new and promising
medicines for the treatment of brain diseases.
Pipeline developments are summarized below.
1) CGRP: Calcitonin gene-related peptide. 2) Three phase III clinical trials, supporting registration in Asia, including China and Japan: SUNLIGHT, SUNRISE, and SUNSET
trials. 3) Long-term safety study. 4) PACAP: Pituitary adenylate cyclase activating peptide. 5) Acts as a partial agonist at 5-HT
1A
and dopamine D
2
receptors at similar potency,
and an antagonist at 5-HT
2A
and noradrenaline alpha
1B/2C
receptors. 6) Monoacylglycerol lipase inhibitor (“MAGlipase”). 7) Spasticity in participants with Multiple Sclerosis.
Hormonal / neuropeptide signaling:
Eptinezumab - development and regulatory
status
Eptinezumab is a monoclonal antibody (mAb) that
binds to calcitonin gene-related peptide (CGRP), a
neuropeptide believed to play a key role in mediating
and initiating migraines, with high specificity and
potency. Eptinezumab is administered as a 30-
minute intravenous (IV) infusion, providing immediate
and complete bioavailability.
In February 2020, Vyepti (eptinezumab-jjmr) was
approved by the U.S. Food and Drug Administration
(FDA) as the first FDA-approved IV treatment for the
treatment of migraine in adults. In January 2022,
Lundbeck announced that the European Commission
has granted marketing authorization for Vyepti in the
European Union (EU) for the prophylactic treatment
of migraine in adults who have at least four migraine
days per month. The approval follows the positive
opinion on November 11, 2021, from the European
Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP). The EU marketing
authorization is valid in all EU Member States,
Iceland, Norway, and Liechtenstein.
Furthermore, Vyepti has been approved in U.A.E.
(December 2020), Canada (January 2021), Kuwait
(May 2021), Australia (June 2021), Singapore
(September 2021), Switzerland (October 2021),
DKK million
H1 2022
H1 2021
FY 2021
Total assets
37,275
34,036
34,653
Shareholder’s equity
19,596
17,540
18,279
Project
Area
Phase I
Phase II
Phase III
Filing/
Launch
Hormonal / neuropeptide signaling:
Eptinezumab (anti-CGRP)
1)
Migraine prevention
PROMISE 1 & 2
Migraine prevention (Asia)
2)
SUN-studies
Episodic cluster headache
ALLEVIATE
Chronic cluster headache
3)
CHRONICLE
Lu AG09222 (anti-PACAP mAb)
4)
Migraine prevention
HOPE
Circuitry / neuronal biology:
Brexpiprazole
5)
Agitation in Alzheimer’s disease
PTSD
Aripiprazole 2-months injectable
Schizophrenia/bipolar I disorder
Lu AG06466
5)
MS spasticity
7)
, PTSD
Lu AF28996 (D
1
/D
2
agonist)
Parkinson’s disease
Protein aggregation, folding and clearance:
Lu AF82422 (anti-α-synuclein mAb)
Multiple system atrophy
AMULET
Lu AF87908 (anti-Tau mAb)
Tauopathies
Neuroinflammation / neuroimmunology:
Lu AG22151 (CD40L inhibitor)
Neurology
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 15
Corporate Release No 728/2022
Israel (December 2021), Great Britain (January
2022), Brazil (February 2022) and Indonesia (May
2022).
Eptinezumab has been submitted for regulatory
review in several additional markets.
During 2021, Lundbeck initiated three phase III
clinical trials, supporting registration in Asia, including
China and Japan. The SUNLIGHT trial
(NCT04772742) is a smaller trial designed to test the
efficacy of eptinezumab to prevent migraine and
headache in patients with the combined diagnosis of
chronic migraine and medication overuse headache.
This first trial including Asian patients was conceived
as an accelerated path to launch in China. Patients
are randomly allocated to placebo or eptinezumab
100 mg given by IV infusion (n=182). The total study
duration is approximately 36 weeks and includes a
Screening Period (28-30 days), a Placebo-controlled
Period (12 weeks), an Open-Label Period (12
weeks), and a Safety Follow-up Period (8 weeks).
The placebo-controlled period has completed. While
the outcomes numerically favored the eptinezumab
arm for the primary and key secondary endpoints, the
study did not reach statistically significant separation
from placebo for the primary endpoint. A more
significant placebo effect was noted vs all prior
eptinezumab studies. Further analyses are ongoing
and the open label and safety follow-up portions of
the study continue.
The SUNRISE trial (NCT04921384) evaluates the
efficacy of eptinezumab to prevent migraine and
headache in patients with chronic migraine. This
study forms the base case for Asian approval across
Japan, China and Korea. Patients will be randomly
allocated to placebo or two treatment groups:
eptinezumab 100 mg or 300 mg given by IV infusion
(n=513). The total study duration is either
approximately 36 weeks, including screening period
and safety follow-up; or 24 weeks for patients in
Japan that enter a separate open label extension trial,
the SUNSET trial (NCT05064371). The SUNSET
study will enroll approximately 100 patients with a
total study duration of approximately 68 weeks.
In 2022, Lundbeck has initiated an explorative,
randomized, pragmatic open label study to evaluate
the comparative effectiveness of eptinezumab
against other advanced preventive medications in a
real-world community setting in adult participants with
episodic or chronic migraine (EVEC, NCT05284019).
The objectives include exploring the comparative
effectiveness on patient-reported outcomes. The
study is planned to enroll 200 patients.
Also, in 2022, Lundbeck has initiated a phase IV
study investigating the add-on efficacy of
eptinezumab treatment to brief educational
intervention, for the preventive treatment of migraine
in patients with a dual diagnosis of migraine and
medication overuse headache (RESOLUTION). The
study (NCT05452239) is planned to recruit around
570 patients that will be randomly assigned to receive
either eptinezumab or placebo given by IV infusion.
The total study duration is approximately 36 weeks
including screening period and safety follow-up.
In December 2020, Lundbeck initiated a phase III
clinical study investigating the efficacy of
eptinezumab in patients with episodic cluster
headache (ALLEVIATE). The study (NCT04688775)
is planned to recruit around 300 patients that will be
randomly assigned to receive treatment consisting of
two infusions of either eptinezumab or placebo in a
cross-over manner. The total duration of the study is
24 weeks, including a safety follow up period of 8
weeks. During 2021, Lundbeck further initiated a 1-
year safety and tolerability trial in participants with
chronic cluster headache (CHRONICLE). The study
(NCT05064397) recently completed recruitment.
Lu AG09222 – phase II
Lu AG09222 represents a potential new therapeutic
option for the treatment of migraine, which unlike the
recently available calcitonin gene-related peptide
(CGRP) migraine treatment drug class, targets
pituitary adenylate cyclase-activating polypeptide
(PACAP). PACAP and its receptors are broadly
expressed in the nervous system, including at sites
implicated in migraine pathophysiology. In pre-clinical
and clinical studies in healthy subjects, Lu AG09222
has shown to bind with high affinity to PACAP,
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Corporate Release No 728/2022
thereby preventing PACAP from activating its
receptors.
In 2021, Lundbeck completed a study confirming the
target engagement of Lu AG09222 with PACAP
(NCT04976309). In this study, the preventive effect
of Lu AG09222 on vasodilation induced by PACAP
was investigated and confirmed. Subsequently, in
November 2021, Lundbeck initiated the HOPE-study,
a randomized, double-blind, phase II, proof of
concept study to assess efficacy, safety, and
tolerability of Lu AG09222 as a treatment for the
prevention of migraine (NCT05133323) which is
currently ongoing. A total of 230 patients, recruited
from specialist settings, will be randomly allocated to
one of three treatment groups: high/low dose of Lu
AG09222 or placebo. In parallel with this, in 2021,
Lundbeck initiated a multiple dose safety,
pharmacokinetic (PK) and pharmacodynamic (PD)
trial in subjects with allergic rhinitis (NCT05126316)
to explore effects of Lu AG09222 in patients with
elevated, circulating inflammatory biomarkers.
Participants receive AG09222 high dose, low dose,
or placebo. The study completed enrollment.
Circuitry / neuronal biology:
Brexpiprazole – phase III in Alzheimer’s agitation
In April 2021, Lundbeck and Otsuka Pharmaceutical
announced the decision to continue the recruitment
of patients in a third phase III clinical trial of
brexpiprazole in the treatment of agitation in patients
with dementia of the Alzheimer's type
(NCT03548584). The decision to continue the trial
was based on the results of an independent interim
analysis, supporting to progress the trial to the
planned full enrollment of 330 patients.
Trial 331-14-213 (NCT03548584; Trial 213) was
designed to assess the safety, tolerability and
efficacy of two fixed doses of brexpiprazole (2 mg/day
and 3 mg/day) in the treatment of patients with
agitation in Alzheimer’s dementia. The trial consisted
of a continuous 12-week double-blind treatment
period with a 30-day follow-up. The randomized trial
population included 345 male and female patients,
aged 55–90 years (inclusive), with a diagnosis of
probable Alzheimer’s disease, and meeting criteria of
agitation as defined by the International
Psychogeriatric Association (IPA). The primary
outcome was the change in the Cohen-Mansfield
Agitation Inventory CMAI total score at week 12 for
all patients treated with brexpiprazole versus those
treated with placebo. The key secondary outcome
was the change in the Clinical Global Impression –
Severity of Illness (CGI-S) score, as related to
symptoms of agitation. Participating countries include
Bulgaria, Hungary, Serbia, Slovakia, Spain, Ukraine,
and USA. The study included both patients who were
living at home and those living in institutionalized
settings.
In June 2022, Lundbeck and Otsuka Pharmaceutical
reported positive results showing reduced agitation in
patients with Alzheimer’s dementia treated with
brexpiprazole. In the study, the improvements from
baseline on the primary endpoint of CMAI for patients
receiving brexpiprazole or 2 mg/day or 3 mg/day were
statistically greater than for those receiving placebo
(p=0.0026). This result was supported by a
statistically superior improvement on the key
secondary endpoint of CGI-S, as related to agitation
(p=0.0055).
Brexpiprazole was generally well tolerated, and no
new safety signals were observed. The only
Treatment Emergent Adverse Event (TEAE) with
more than 5% incidence in patients treated with
brexpiprazole was headache (6.6% vs. 6.9% for
placebo). The following TEAEs occurred at an
incidence of at least 2% in brexpiprazole treatment
group and greater than that of placebo: somnolence,
nasopharyngitis, dizziness, diarrhea, urinary tract
infection, and asthenia. There was one death
observed in the 3 mg/day treatment group, assessed
as not related to treatment by the investigator.
Based on this outcome Lundbeck and Otsuka are
planning a regulatory filing to the FDA later in 2022.
The Supplemental New Drug Application will be
comprised of this study as well as two earlier trials. In
February 2016, the FDA granted fast track
designation for brexpiprazole for treatment of
agitation in patients with Alzheimer’s dementia.
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Corporate Release No 728/2022
Brexpiprazole – phase III in Post-Traumatic
Stress Disorder (PTSD)
PTSD is a psychiatric disorder that can develop as a
response to traumatic events, such as interpersonal
violence, combat, life-threatening accidents or
natural disasters. Core features of PTSD include a
variety of symptoms, such as re-experiencing
phenomena (i.e., flashbacks and nightmares),
avoidance behavior, numbing (i.e., amnesia,
anhedonia, withdrawal, negativism) and increased
arousal (i.e., insomnia, irritability, poor concentration,
hypervigilance). Psychiatric co-morbidities are
common, and PTSD sufferers can also present with
substance abuse, mood and other anxiety disorders,
impulsive and dangerous behavior, and self-harm.
Lundbeck and Otsuka Pharmaceutical reported
positive phase II data for the combination treatment
of brexpiprazole and sertraline for the treatment of
PTSD in November 2018. On basis of these data,
Lundbeck and Otsuka Pharmaceutical initiated two
pivotal phase III trials (NCT04124614; n=577 and
NCT04174170; n=733), investigating the use of
brexpiprazole in combination with sertraline in the
treatment of PTSD, subsequent to an End of Phase
II meeting with the U.S. FDA in May 2019. The
execution of those two ongoing studies is challenged
by the COVID-19 pandemic, primarily impacting
enrollment rates. Therefore, Lundbeck and Otsuka
Pharmaceutical have been seeking phase III program
advice from the U.S. FDA. At a Type C meeting, the
proposal for how to address the slow enrollment rates
by reducing sample size was discussed with the FDA.
Headline results are expected sometime during first
half 2023.
Aripiprazole – 2-Month Injectable (LAI)
formulation
In July 2019, Lundbeck and Otsuka Pharmaceutical
initiated a pivotal phase Ib study (NCT04030143) to
determine the safety, tolerability, and
pharmacokinetics of multiple-dose administrations of
aripiprazole to adult participants with schizophrenia
or bipolar I disorder. The study was an open-label,
multiple-dose, randomized, parallel-arm, multicenter
study. In addition to assessment of safety and
tolerability, the objective was to establish the
similarity of aripiprazole concentrations on the last
day of the dosing interval and the exposure in the last
dosing interval following the final administration of
aripiprazole into the gluteal muscle site. The study
showed that the new 2-month formulation provided
effective plasma concentrations of aripiprazole for
two months, while being safe and tolerable.
A long-acting injectable formulation ensures
continuous exposure to medication and through a
simplified treatment regimen, many of the challenges
with poor treatment adherence may be mitigated,
resulting in a potential positive impact on patient
outcomes.
The new 2-month formulation is an innovative
addition to the LAI franchise and has patent
protection until the early part of the next decade.
Lundbeck and Otsuka Pharmaceutical submitted the
Marketing Authorisation Application (MAA) for
aripiprazole as a 2-month ready-to-use (RTU) long-
acting injectable (LAI) for the maintenance treatment
of schizophrenia in adult patients stabilized with
aripiprazole to the European Medicines Agency
(EMA) as well as to the U.S FDA for the treatment of
schizophrenia and bipolar disorder in second quarter
of 2022.
Lu AG06466 – phase Ib
Lu AG06466 (formerly ABX1431) is an inhibitor of the
monoacylglycerol lipase (MAGL) and selective
modulator of the endocannabinoid system, and
thereby works to reduce excessive neuro-
transmission and neuroinflammation that are known
pathophysiological hallmarks for a range of
psychiatric and neurological disorders. A phase Ib
study was initiated in September 2020 with the
purpose to investigate the effect of Lu AG06466 after
multiple doses in patients with PTSD
(NCT04597450). Another phase Ib investigational
study was initiated in multiple sclerosis spasticity in
September 2021 (NCT04990219). A phase Ib study
in patients with treatment resistant focal epilepsy was
terminated in July 2022 due to recruitment
challenges.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 18
Corporate Release No 728/2022
Lu AF28996 – phase I
Lu AF28996 is a small molecule with agonistic
properties towards D1 and D2 receptors. Continuous
D1 and D2 dopamine receptor stimulation may play
an important role in motor control of Parkinson’s
disease patients. A phase Ib study was initiated in
February 2020 with the purpose to investigate the
safety and tolerability as well as pharmacokinetics of
Lu AF28996 in patients with Parkinson's disease
(NCT04291859).
Protein aggregation, folding and clearance:
Lu AF82422 – phase II
Lu AF82422 is a monoclonal antibody (mAb)
targeting the pathological form of the protein alpha-
synuclein that is believed to play a pivotal role in the
development and progression of multiple system
atrophy (MSA), Parkinson’s disease (PD), and other
neurodegenerative diseases, such as
synucleinopathies. By targeting pathological alpha-
synuclein with an antibody that will inhibit aggregation
and potentially clear pathological alpha-synuclein
from the brain, the project aims to demonstrate delay
of disease progression with a therapeutic effect on
disease burden and function. Lu AF82422 has been
demonstrated to be well-tolerated in a phase I single-
ascending dose study, which was completed in July
2021. A phase II study (AMULET) was initiated in
November 2021 (NCT05104476). The primary
objective of the study is to evaluate the efficacy of Lu
AF82422 versus placebo on disease progression in
patients with MSA. Orphan drug designation for MSA
was granted by EMA in April 2021.
Lu AF87908 – phase I
Lu AF87908 is a monoclonal antibody (mAb)
targeting the pathological form of the hyper-
phosphorylated tau protein, which is believed to play
a pivotal role in the development and progression of
Alzheimer’s disease and other tau-driven
neurodegenerative disorders (primary tauopathies).
Lu AF87908 binds to a specific tau epitope (pS396-
tau) which is a dominating phosphorylation site in
pathological tau. A phase I program on Lu AF87908
was initiated in September 2019 to investigate the
safety and tolerability as well as pharmacokinetics of
a single dose of Lu AF87908, in healthy subjects and
patients with Alzheimer's Disease (NCT04149860).
Trial execution has been delayed as accrual of
patients has been impacted by COVID-19.
Neuroinflammation / neuroimmunology:
In October 2021, Lundbeck acquired an exclusive
license to Lu AG22515 (formerly APB-A1) from
AprilBio Co. Ltd in South Korea. Lu AG22515 is a
high-affinity human mAb that blocks the
CD40L/CD40 pathway through direct neutralization
of CD40L, thereby affecting adaptive and innate
immune responses. Lu AG22515 holds strong
promise in the treatment of a wide range of
autoimmune-related CNS disorders and neurological
diseases with autoreactive T-cells, B-cells and
marked presence of autoantibodies and
inflammation. An Investigational New Drug (IND) has
been opened in the U.S., and a First in Human study
(NCT05136053) testing single ascending doses of Lu
AG22515 in healthy volunteers was initiated in March
2022.
Sustainability update
Climate and energy
Lundbeck is committed to climate neutrality and is
working towards a 15-year climate target approved by
the Science Based Target initiative in 2021. When
comparing first half of 2022 with first half of 2021
Scope 1 and 2 emissions are down by 17% primarily
due to full conversion to renewable electricity at the
two Danish sites from January 2022. Scope 3 GHG
emissions from business travel has increased due to
removal of travel restrictions after the pandemic,
however, it is still below 2019 pre-pandemic level. A
Climate friendly travel policy and campaign will be
rolled out during the third quarter of 2022 to curb
emissions.
General waste recycling rate
The corporate recycling rate of general waste in the
first half of 2022 is 66.4%, slightly decreased overall
since same period last year. Mainly due to better
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 19
Corporate Release No 728/2022
waste sorting facilities of packaging material at the
Valby site.
Health & Safety
In the first half of 2022, similar to second half of 2021,
the number of work-related accidents with absence is
11, which gives a frequency of 6.2 (the target being
5.0). Accidents and near-misses are analyzed to
identify the root cause and preventive actions are
continuously being taken including training. Action
plans as well as global initiatives to address the
number of accidents on all sites have been agreed
upon and will be launched in 2022 and 2023.
Additionally, a new employee well-being framework
was designed in H1 2022. Actions and activities to
build on Lundbeck’s well-being culture, which also
addresses mental health, will be launched in 2022
and 2023.
Business Ethics
50 new Compliance Hotline reports were received in
the first half of 2022. The increase is largely attributed
to an update in the accounting principles to more
accurately reflect the number of reports received.
From 2022, Lundbeck records each report
separately, regardless of whether they are found to
be substantially duplicative or out of scope. In the first
and second quarter of 2022, Lundbeck received a
large volume of separate but related reports. Using
the old accounting principles, we have calculated that
18 cases would have been reported in the first half of
2022 compared with 14 cases in the same period in
2021.
In the first half of 2022, Due Diligence assessments
of 67 potential third parties were conducted, which
identified 11 potential cases where one of more
issues will be mitigated and monitored if the
collaboration agreement is executed. In response to
the rapidly changing sanctions & export controls
environment, Lundbeck implemented controls to
secure existing and new high-risk third parties were
screened for restrictions and is reviewing its
governance to meet these obligations.
Sustainability Key Performance Indicators
Category
H1 2022
H1 2021
Change (%)
Number of employees (FTE)
5,437
5,603
(3.0%)
Scope 1 GHGs (Tonne CO
2-
e)
11,153
12,501
(-11%)
Scope 2 GHGs – market based (Tonne CO
2-
e)
2,307
3,775
(-39%)
Scope 1+2 GHGs (Tonne CO
2-
e)
13,460
16,276
(-17%)
Scope 3 GHG's: Purchased goods and services (Tonne CO
2-
e)
56,857
57,396
(-1%)
Scope 3 GHG's: Up-stream transportation and distribution (Tonne CO
2-
e)
4,863
5,286
(-8%)
Scope 3 GHG's: Business travel (Tonne CO
2-
e)
5,047
1,294
(290%)
Energy consumption (MWh)
55,654
56,591
(-1,7%)
Recycling rate – General waste (%)
66.4
69.2
(4.0%)
Frequency of lost time accidents (Frequency)
6.2
6.2
0%
Work-related accidents with absence (Number)
11
11
0%
Compliance Hotline reports (Number)
50
14
N/A
Due Diligence screenings of suppliers and third parties (Number)
67
67
0%
Note: See Lundbeck Sustainability Report 2021 for accounting principles and definitions. 2021 company car emission estimated based on annual emission. Compliance
Hotline accounting principles have been updated to reflect the total number of cases received, including multiple reports involving the same issues and out-of-scope reports.
Using the old accounting principles, we have calculated that 18 cases would have been reported in the first half of 2022 compared with 14 cases in H1 2021
General corporate matters
Pending legal proceedings
Lundbeck is involved in a number of legal
proceedings, including patent disputes, the most
significant of which are described below. The
outcome of these proceedings is not expected to
have a material impact on the Group’s financial
position or cash flows beyond the amount already
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 20
Corporate Release No 728/2022
provided for in the financial statements, or it is too
uncertain to make a reliable provision. Such
proceedings will, however, develop over time, and
new proceedings may occur which could have a
material impact on the Group’s financial position
and/or cash flows.
In June 2013, Lundbeck received the European
Commission’s decision that agreements concluded
with four generic competitors concerning citalopram
violated competition law. The decision included fining
Lundbeck EUR 93.8 million (approximately DKK 700
million). Lundbeck paid and expensed the fine in the
third quarter of 2013. In March 2021 the European
Court of Justice rejected Lundbeck’s final appeal of
the European Commission’s decision. So-called
“follow-on claims” for reimbursement of alleged
losses, resulting from alleged violation of competition
law, often arise when decisions and fines issued by
the European Commission are upheld by the
European Court of Justice. Health authorities in the
UK and an umbrella organization of Dutch health
insurance companies have taken formal protective
steps against Lundbeck with the principal purpose of
preventing potential claims from being time-barred
under the applicable statutes of limitation. In
September 2021, the UK proceedings were
transferred from the High Court to the Competition
Appeal Tribunal at the request of the parties.
Lundbeck expects that the UK health authorities will
now pursue their alleged claims. Further, in late
October 2021, Lundbeck received a writ of summons
from a German health care company claiming
compensation for an alleged loss of profit plus
interest payments, allegedly resulting from
Lundbeck’s conclusion of agreements with two of the
four generic competitors, which were comprised by
the EU Court of Justice ruling. Lundbeck has filed its
defense in May 2022 and it may take several years
before a final conclusion is reached by the German
courts. Finally, in March and April 2022 several
Lundbeck entities received letters from a number of
the regional health authorities in Spain specifically
stating that they are intended to interrupt the statute
of limitation. It is still uncertain whether the health
authorities in Spain will actively pursue any claims.
Lundbeck disagrees with all claims and intends to
defend itself against them.
In Canada, Lundbeck is involved in three product
liability class-action lawsuits relating to
Cipralex/Celexa
®
(two cases alleging various Celexa-
induced birth defects and one case against several
SSRI manufacturers (incl. Lundbeck) alleging that
SSRI (Celexa/Lexapro) induces autism birth defect),
three relating to Abilify Maintena (alleging i.a. failure
to warn about compulsive behavior side effects) and
one relating to Rexulti (also alleging i.a. failure to
warn about compulsive behavior side effects). The
cases are in the preliminary stages and as such there
is significant uncertainty as to how these lawsuits will
be resolved. Lundbeck strongly disagrees with the
claims raised.
In 2018, Lundbeck entered into settlements with three
of four generic companies involved in an Australian
federal court case, in which Lundbeck was pursuing
patent infringement and damages claims over the
sale of escitalopram products in Australia. Lundbeck
received AUD 51.7 million (DKK 242 million) in 2018.
In Lundbeck’s case against the last of the four generic
companies, Sandoz Pty Ltd, the Federal Court found
that Sandoz Pty Ltd had infringed Lundbeck’s
escitalopram patent between 2009 and 2012 and
awarded Lundbeck AUD 26.3 million in damages.
Sandoz’ appeal of the decision was heard in May
2019 and the Full Federal Court has in August 2020
allowed Sandoz' appeal and decided that Sandoz is
not liable for damages. The High Court of Australia
has now allowed Lundbeck’s appeal and overturned
the Full Federal Court decision on all major issues.
The case will be sent back to the Federal Court for
recalculation of damages and Lundbeck’s appeal of
the Australian Patent Office’s decision to grant
Sandoz a license will be restarted.
Together with Takeda, Lundbeck instituted patent
infringement proceedings against 16 generic
companies in response to their filing of Abbreviated
New Drug Applications (“ANDAs”) with the U.S. FDA
seeking to obtain marketing approval for generic
versions of Trintellix in the U.S. Two opponents have
since withdrawn and Lundbeck has settled with eight
opponents. As communicated by Lundbeck in
company release no. 706 dated October 1, 2021, the
cases against the six remaining opponents (the
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 21
Corporate Release No 728/2022
“ANDA Filers”) has been decided by the U.S. District
Court for the District of Delaware (the ‘Court’). The
Court found that Lundbeck’s patent protecting the
active ingredient in Trintellix, vortioxetine (U.S.
Patent No. 7,144,884) is valid. The active ingredient
patent expires on June 17, 2026, with an expected
six-month pediatric exclusivity period extending to
December 17, 2026. Assuming the ruling is confirmed
at appeal, final approval will not be granted to the
relevant ANDA Filers until after expiration of the
active ingredient patent, including any extension or
additional periods of exclusivity. A total of seven other
patents asserted at trial were found by the Court to
be valid or their validity was not challenged during the
trial. The Court decided that none of the seven other
patents were infringed by the relevant ANDA Filers,
except that Lupin was found to infringe a patent
covering Lundbeck’s process for manufacturing
vortioxetine. Unless and until the Court’s ruling is
reversed on appeal, the patents found not infringed
by a particular ANDA Filer will not prevent that ANDA
Filer from receiving final approval. For details on each
of the patents comprised by the case, please see the
company release no. 706. The Court’s decision has
been appealed by Lundbeck to the U.S. Court of
Appeals for the Federal Circuit. Lupin has appealed
with respect to the process patent and the ANDA
Filers have cross appealed with respect to the validity
of two of the seven other patents. The validity of the
compound patent has not been challenged under the
appeal.
Together with Otsuka Pharmaceutical, Lundbeck has
instituted patent infringement proceedings against
several generic companies that have applied for
marketing authorization for generic versions of
Rexulti in the U.S. Lundbeck has strong confidence
in the Rexulti patents. The U.S. FDA cannot grant
marketing authorization in the U.S. to the generic
companies before the patents expire unless the
generic companies receive decisions in their favor.
Trial is scheduled to be held in October 2022. The
compound patent, including patent term extensions,
will expire in the U.S. on June 23, 2029. A patent for
the specific formulation used will expire September
12, 2032.
Lundbeck received a Civil Investigative Demand
(“CID”) from the U.S. Department of Justice (“DOJ”)
in March 2020. The CID seeks information regarding
the sales, marketing, and promotion of Trintellix.
Lundbeck is cooperating with the DOJ.
Lundbeck and Otsuka have received a Paragraph IV
certification from Mylan Pharmaceuticals with respect
to certain of the patent listed for Abilify Maintena in
the U.S., and Lundbeck and Otsuka have instituted
patent infringement proceedings against Mylan and
Viatris Inc. The U.S. FDA cannot grant marketing
authorization in the U.S. to Mylan or Viatris Inc.
before the patents expire unless they receive a
decision in their favor. A District Court decision is
currently expected by August 2024. Abilify Maintena
is covered by several US patents relating to specific
forms of the active ingredient, formulations,
processes, devices, indications and methods of use,
which will expire in different years, with the latest
patent expiry date in the U.S. being in 2034.
In June 2022 in the U.S., several entities created for
the purpose of receiving assignment of claims from
payors providing health insurance coverage pursuant
to Medicare Parts C and D and Medicaid filed a
complaint against Lundbeck and others. The
complaint alleges that Lundbeck and the other
defendants conspired to increase the unit price and
quantity dispensed of Xenazine. Lundbeck denies the
allegations in the complaint and intends to defend
itself.
Conference call
Today at 13.00 CET, Lundbeck will be hosting a
conference call for the financial community. You can
find dial-ins and a link for webcast online at
www.lundbeck.com under the Investor section.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 22
Corporate Release No 728/2022
STATEMENT OF THE BOARD OF DIRECTORS AND THE
REGISTERED EXECUTIVE MANAGEMENT
The Board of Directors and the Registered Executive Management have discussed and adopted the interim report
of H. Lundbeck A/S for the period January 1 to June 30, 2022. The interim report is presented in accordance with
IAS 34 Interim Financial Reporting, as adopted by the EU and additional Danish disclosure requirements for the
interim reports of listed companies.
We consider the accounting policies applied to be appropriate. Accordingly, the interim report gives a true and fair
view of the Group’s assets, liabilities and financial position as of June 30, 2022, and of the results of the Group’s
operations and cash flows for the period, which ended on June 30, 2022.
In our opinion, the Management’s Review gives a true and fair view of activity developments, the Group’s general
financial position and the results for the period. It also gives a fair view of the significant risks and uncertainty factors
that may affect the Group relative to the disclosures in the Annual Report 2021.
The interim report has not been subject to audit or reviewed by the company’s independent auditors.
Registered Executive Management
Board of Directors
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 23
Corporate Release No 728/2022
CONDENSED FINANCIAL STATEMENTS
Statement of profit or loss
DKK million
H1 2022
H1 2021
Q2 2022
Q2 2021
FY 2021
Revenue
Cost of sales
Gross profit
Sales and distribution costs
Administrative expenses
Research and development costs
Profit from operations (EBIT)
Net financials, expenses
(25 )
Profit before tax
Tax on profit for the period
Profit for the period
Earnings per share, basic (EPS) (DKK)
Earnings per share, diluted (DEPS) (DKK)
Statement of comprehensive income
DKK million
H1 2022
H1 2021
Q2 2022
Q2 2021
FY 2021
Profit for the period
Actuarial gains/losses
(1 )
Tax
Items that will not be reclassified subsequently to profit or
loss
(1 )
Exchange rate gains/losses on investments in foreign subsidiaries
(122 )
Exchange rate gains/losses on additions to net investments in
foreign subsidiaries
(48 )
(85 )
(40 )
(157 )
Hedging of net investments in foreign subsidiaries
(168 )
(67 )
(142 )
(127 )
Deferred gains/losses on cash flow hedge, exchange rate
(408 )
(141 )
(265 )
(340 )
Deferred gains/losses on cash flow hedge, interest rate
Deferred gains/losses on cash flow hedge, price
Exchange gains/losses, hedging (transferred to the hedged items)
(102 )
(34 )
(53 )
Tax
Items that may be reclassified subsequently to profit or loss
(23 )
Other comprehensive income
(23 )
Comprehensive income
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 24
Corporate Release No 728/2022
Condensed statement of financial position
DKK million
30.06.2022
30.06.2021
31.12.2021
Assets
Intangible assets
Property, plant and equipment
Other financial assets
Other receivables
Deferred tax assets
Non-current assets
Inventories
Receivables
Cash and bank balances
Current assets
Assets
Equity and liabilities
Share capital
Foreign currency translation reserve
Hedging reserve
(183 )
(62 )
(162 )
Retained earnings
Equity
Retirement benefit obligations
Deferred tax liabilities
Provisions
Bank debt and bond debt
Lease liabilities
Other payables
Non-current liabilities
Retirement benefit obligations
Provisions
Trade payables
Lease liabilities
Income taxes payable
Other payables
Current liabilities
Liabilities
Equity and liabilities
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 25
Corporate Release No 728/2022
Statement of changes in equity
DKK million
Share capital
Foreign
currency
translation
reserve
Hedging
reserve
Retained
earnings
Total equity
Equity at January 1, 2022
(162 )
Profit for the period
Other comprehensive income
(21 )
Comprehensive income
(21 )
Distributed dividends, gross
(398 )
(398 )
Dividends received, treasury shares
Buyback of treasury shares
(45 )
(45 )
Incentive programmes
Tax on other transactions in equity
Other transactions
(429 )
(429 )
Equity at June 30, 2022
(183 )
DKK million
Share capital
Foreign
currency
translation
reserve
Hedging
reserve
Retained
earnings
Total equity
Equity at January 1, 2021
Profit for the period
Other comprehensive income
(157 )
Comprehensive income
(157 )
Distribution of dividends, gross
(498 )
(498 )
Dividends received, treasury shares
Buyback of treasury shares
(34 )
(34 )
Incentive programmes
Tax on other transactions in equity
Other transactions
(511 )
(511 )
Equity at June 30, 2021
(62 )
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 26
Corporate Release No 728/2022
Condensed statement of cash flows
DKK million
H1 2022
H1 2021
Q2 2022
Q2 2021
FY 2021
Profit from operations (EBIT)
Adjustments for non-cash items
Change in working capital
(816 )
(728 )
(305 )
Cash flows from operations before financial receipts and
payments
Financial receipts and payments
(488 )
(95 )
(3 )
(91 )
(132 )
Cash flows from ordinary activities
Income taxes paid
(118 )
(304 )
(54 )
(236 )
(449 )
Cash flows from operating activities
Contingent consideration, payment from acquisitions of business
(1,076 )
Purchase and sale of intangible assets and property, plant and
equipment
(151 )
(194 )
(64 )
(110 )
(610 )
Cash flows from investing activities
(1,227 )
(194 )
(64 )
(110 )
(610 )
Cash flows from operating and investing activities
(free cash flow)
(516 )
Proceeds from loans and issue of bonds
Repayment of bank loans and borrowings
(266 )
(2,552 )
(168 )
(400 )
(3,123 )
Dividends paid in the financial year, net
(397 )
(497 )
(497 )
Other financing activities
(91 )
(74 )
(21 )
(20 )
(116 )
Cash flows from financing activities
(2,723 )
(189 )
(420 )
(3,336 )
Net cash flow for the period
(36 )
(2,247 )
(1,674 )
Cash and bank balances at beginning of period
Unrealized exchange gains/losses on cash and bank balances
(2 )
Net cash flow for the period
(36 )
(2,247 )
(1,674 )
Cash and bank balances at end of period
Interest-bearing debt, cash, bank balances and securities, net,
is composed as follows:
Cash and bank balances
Interest-bearing debt
(6,585 )
(5,930 )
(6,585 )
(5,930 )
(5,468 )
Net cash/(net debt)
(4,287 )
(4,239 )
(4,287 )
(4,239 )
(3,189 )
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 27
Corporate Release No 728/2022
Statement of profit or loss – Core results reconciliation (H1)
H1 2022
DKK million
Reported
result
Amortization
of product
rights
Impairment
and
inventory
valuation
Major
restructuring
Acquisition
and
integration
costs
Legal fees
and
settlements
Divestments
/ sales
milestones
Core result
Revenue
8,847
-
-
-
-
-
-
8,847
Cost of Sales
1,811
(624)
-
-
-
-
-
1,187
Gross profit
7,036
624
-
-
-
-
-
7,660
Sales and distribution costs
3,087
-
-
43
-
-
-
3,130
Administrative expenses
509
-
-
-
-
-
-
509
Research and development costs
1,943
-
-
5
-
-
-
1,948
Profit from operations (EBIT)
1,497
624
-
(48)
-
-
-
2,073
Net financials, expenses
322
-
-
-
-
-
(278)
44
Profit before tax
1,175
624
-
(48)
-
-
278
2,029
Tax on profit for the period
258
144
-
(10)
-
-
-
392
Profit for the period
917
480
-
(38)
-
-
278
1,637
Earnings per share, basic (EPS)
0.92
0.49
-
(0.04)
-
-
0.28
1.65
H1 2021
DKK million
Reported
result
Amortization
of product
rights
Impairment
and
inventory
valuation
Major
restructuring
Acquisition
and
integration
costs
Legal fees
and
settlements
Divestments
/ sales
milestones
Core result
Revenue
8,233
-
-
-
-
-
-
8,233
Cost of sales
1,797
(669)
-
-
-
-
-
1,128
Gross profit
6,436
669
-
-
-
-
-
7,105
Sales and distribution costs
2,712
-
-
-
-
-
-
2,712
Administrative expenses
425
-
-
-
-
-
-
425
Research and development costs
1,821
-
-
-
-
-
-
1,821
Profit from operations (EBIT)
1,478
669
-
-
-
-
-
2,147
Net financials, expenses
197
-
-
-
-
-
-
197
Profit before tax
1,281
669
-
-
-
-
-
1,950
Tax on profit for the period
282
137
-
-
-
-
-
419
Profit for the period
999
532
-
-
-
-
-
1,531
Earnings per share, basic (EPS)
1
1.01
0.53
-
-
-
-
-
1.54
1 The calculation of EPS is based on a share denomination of DKK 1 as a result of the share split completed on June 8, 2022. Comparative figures have been restated, to
reflect the change in trading unit from a nominal value of DKK 5 to DKK 1.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 28
Corporate Release No 728/2022
Statement of profit or loss – Core results reconciliation (Q2)
Q2 2022
DKK million
Reported
result
Amortization
of product
rights
Impairment
and
inventory
valuation
Major
restructuring
Acquisition
and
integration
costs
Legal fees
and
settlements
Divestments
/ sales
milestones
Core result
Revenue
4,475
-
-
-
-
-
-
4,475
Cost of Sales
966
(315)
-
-
-
-
-
651
Gross profit
3,509
315
-
-
-
-
-
3,824
Sales and distribution costs
1,652
-
-
43
-
-
-
1,695
Administrative expenses
273
-
-
-
-
-
-
273
Research and development costs
962
-
-
5
-
-
-
967
Profit from operations (EBIT)
622
315
-
(48)
-
-
-
889
Net financials, expenses
(25)
-
-
-
-
-
-
(25)
Profit before tax
647
315
-
(48)
-
-
-
914
Tax on profit for the period
142
73
-
(10)
-
-
-
205
Profit for the period
505
242
-
(38)
-
-
-
709
Earnings per share, basic (EPS)
0.51
0.24
-
(0.04)
-
-
-
0.71
Q2 2021
DKK million
Reported
result
Amortization
of product
rights
Impairment
and
inventory
valuation
Major
restructuring
Acquisition
and
integration
costs
Legal fees
and
settlements
Divestments
/ sales
milestones
Core result
Revenue
3,960
-
-
-
-
-
-
3,960
Cost of sales
851
(298)
-
-
-
-
-
553
Gross profit
3,109
298
-
-
-
-
-
3,407
Sales and distribution costs
1,394
-
-
-
-
-
-
1,394
Administrative expenses
215
-
-
-
-
-
-
215
Research and development costs
904
-
-
-
-
-
-
904
Profit from operations (EBIT)
596
298
-
-
-
-
-
894
Net financials, expenses
112
-
-
-
-
-
-
112
Profit before tax
484
298
-
-
-
-
-
782
Tax on profit for the period
106
69
-
-
-
-
-
175
Profit for the period
378
229
-
-
-
-
-
607
Earnings per share, basic (EPS)
1
0.38
0.23
-
-
-
-
-
0.61
1 The calculation of EPS is based on a share denomination of DKK 1 as a result of the share split completed on June 8, 2022. Comparative figures have been restated, to
reflect the change in trading unit from a nominal value of DKK 5 to DKK 1.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 29
Corporate Release No 728/2022
Notes
Note 1: Accounting policies
The interim condensed consolidated financial statements for the six months ended June 30, 2022, have been prepared in
accordance with IAS 34 Interim Financial Reporting as adopted by the EU and additional Danish disclosure requirements
for the interim reports of listed companies. The interim condensed consolidated financial statements do not include all the
information and disclosures required in the annual financial statements and should be read in conjunction with the Group’s
annual consolidated financial statements as at December 31, 2021, published February 9, 2022. The accounting policies,
judgements and significant estimates are consistent with those applied in the Annual Report 2021.
A number of new amendments came into effect from January 1, 2022. None of the amendments have a material impact
on the accounting policies and/or on the condensed consolidated financial statements.
Lundbeck’s geographical structure was changed effective January 1, 2022. Following the change, the geographical split
of revenue has been subject to modifications. With the new geographical structure, Canada moved from North America to
International Markets and smaller entities were moved between International Markets and Europe. The North America
region has been renamed United States to better reflect its new composition. Comparative figures for 2021 have been
adjusted following the new geographical structure.
On June 8, 2022, the Company’s shareholders approved a share split of Lundbeck’s existing shares. The approval entailed
that each existing Lundbeck-share with a nominal value of DKK 5 was split into one A share with a nominal value of DKK
1 and four B shares each with a nominal value of DKK 1. The A-share is carrying ten votes and the B-share is carrying one
vote. The A-shares and the B-shares are ordinary, fully paid shares carrying equal economic rights in all respects. As a
result, all share and per share information has been retrospectively adjusted for all periods presented to reflect the impacts
of the share split transaction.
Note 2: Fair value measurement
Financial assets and financial liabilities measured or
disclosed at fair value
Level 1
Level 2
Level 3
(DKKm)
(DKKm)
(DKKm)
June 30, 2022:
Financial assets
Other financial assets
1
86
-
28
Derivatives
1
-
226
140
Total
86
226
168
Financial liabilities
Contingent consideration
1
-
-
448
Derivatives
1
-
593
Bank debt²
-
2,219
-
Bond debt²
3,300
-
-
Total
3,300
2,812
448
December 31, 2021:
Financial assets
Other financial assets
1
22
-
35
Derivatives
1
-
41
-
Total
22
41
35
Financial liabilities
Contingent consideration
1
-
-
1,623
Derivatives
1
-
243
-
Bank debt2²
-
1,083
-
Bond debt2²
3,755
-
-
Total
3,755
1,326
1,623
1) Measured at fair value. 2) Disclosed at fair value.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 30
Corporate Release No 728/2022
The fair value of securities is based on publicly quoted prices of the invested assets. The fair value of derivatives is
calculated by applying recognized measurement techniques, whereby assumptions are based on the market conditions
prevailing at the balance sheet date. The fair value of contingent consideration is calculated as the discounted cash
outflows (DCF method) from future milestone payments, taking probability of success into consideration.
During the first quarter of 2022, the Vyepti EMA approval triggered a payment of CVR to former Alder shareholders
(consequently changed to Lundbeck Seattle BioPharmaceuticals, Inc.). The CVR payment amounted to DKK 1,566 million.
The fair value adjustment of contingent consideration amounted to a net loss of DKK 326 million as a result of changes in
the fair value of the CVR of which DKK 278 million relates to the update of the probability of success of milestone payments
occurred in the first quarter 2022.
Total contingent consideration amounted to DKK 448 million at June 30, 2022 (DKK 1,623 million at December 31, 2021).
Besides the CVR payment and fair value adjustment, the only change in contingent consideration is exchange rate
adjustments of DKK 65 million.
The carrying amount of other receivables, trade receivables, prepayments, other debt, trade payables and other payables
is believed to be equal to or close to fair value.
Note 3: EBITDA calculation
DKK million
H1 2022
H1 2021
Q2 2022
Q2 2021
FY 2021
EBIT
1,497
1,478
622
596
2,010
+ Depreciation, amortization and
impairment losses
842
869
427
399
1,710
= EBITDA
2,339
2,347
1,049
995
3,720
Note 4: Core reporting
As a general rule, Lundbeck adjusts for amortization of product rights and for each non-recurring item that Management
deems exceptional and/or which accumulates or is expected to accumulate to an amount exceeding a DKK 100 million
threshold. Lundbeck’s core reporting is a non-IFRS performance measurement. Lundbeck’s core results, including core
operating income (core EBIT) and core EPS, exclude:
Amortization of product rights
Impairment of intangible assets and property, plant and equipment as well as inventory valuation adjustments
Major restructurings
Acquisition and integration costs, including:
• Accounting adjustments relating to the consolidation of material acquisitions and disposals of associates,
products and businesses
• Costs associated with the integration of newly acquired companies
• Retention costs
• Transaction costs
Legal fees and settlements, including:
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO JUNE 30, 2022 Page 31
Corporate Release No 728/2022
• Legal costs (external), charges (net of insurance recoveries) and expenses related to settlement of litigations,
government investigations and other disputes
• Income from settlements of litigations and other disputes
Divestments/milestones, including:
• Income/expenses from discontinued operations
• Gains/losses on divestments of assets
• Received or expensed upfront sales and development milestones
• Adjustments in probability of success embedded in milestone calculations
The adjusted core result is taxed at the underlying corporate tax rate.
FINANCIAL CALENDAR 2022
9 November 2022: Financial statements for the first nine months of 2022
Lundbeck contacts
Investors:
Media:
Palle Holm Olesen
Thomas Mikkel Mortensen
Vice President, Investor Relations
Media Relations Lead
PALO@lundbeck.com
THMR@lundbeck.com
+45 30 83 24 26
+45 36 43 40 00
About Lundbeck
For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to
restoring brain health, so every person can be their best.
Too many people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless
take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination
against people living with brain diseases and advocating for broader social acceptance of people with brain health
conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.
We have approximately 5,600 employees in more than 50 countries, and our products are available in more than
100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our
pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any
therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are
located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR ~2.2 billion;
USD ~2.6 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on
Instagram (h_lundbeck), Twitter at @Lundbeck and via LinkedIn.