QUARTERLY RELEASE FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022
Corporate Release No 730/2022
Financial report for the period January 1 to September 30, 2022
Lundbeck’s sales increased by 11% (+6% in local
currencies) to DKK 13.6 billion in the first nine months of
2022
HIGHLIGHTS
Growth of Lundbeck’s strategic brands accelerates further growing 30% (+19% in local currencies) in the first nine
months of 2022 thereby reaching DKK 8.8 billion, representing 65% of overall revenue.
• Brintellix
®
/Trintellix
®
: +24% reported to DKK 3,177 million (+15% in local currencies)
• Rexulti
®
/Rxulti
®
: +33% reported to DKK 2,817 million (+19% in local currencies)
• Abilify Maintena
®
: +20% reported to DKK 2,164 million (+13% in local currencies)
• Vyepti
®
: +105% reported to DKK 672 million (+82% in local currencies)
All markets contribute to revenue momentum with total revenue growing 11% (+6% in local currencies to DKK
13,566 million
• United States: +19% reported to DKK 6,585 million (+6% in local currencies)
• International Markets: +13% reported to DKK 4,023 million (+5% in local currencies)
• Europe: +11% reported to DKK 3,154 million (+11% in local currencies)
Currency favorability on product sales partially offset by negative hedging effects of DKK 401 million. Individual cost
items significantly impacted by exchange rates. However, Core EBIT margin improved from 24.3% to 24.9% for the
first nine months of 2022 and further improved from 20.6% to 27.5% in the third quarter despite investments in
marketing and sales costs underpinning the launch of Vyepti in several markets during 2022.
• EBITDA: +14% reported to DKK 3,753 million
• EBIT: +22% reported to DKK 2,449 million
• Core EBIT: +13% reported to DKK 3,372 million
• EPS: +22% reported to DKK 1.62
• Core EPS: +24% reported to DKK 2.61
In connection with the financial report, Lundbeck’s President and CEO, Deborah Dunsire said:
“Reporting 11% growth in our total revenues with our strategic brands themselves growing 30% underlines the
strong momentum in the Lundbeck business. Our R&D transformation is advancing strongly. Lundbeck has
substantial growth ahead and we will invest behind those opportunities.”
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 generally
increased activity level and concurrent investments in acceleration and global launch of Vyepti
• Revenue expected at DKK 17.9 – 18.2 billion
• EBITDA expected at DKK 4.4 – 4.6 billion
• Core EBIT expected at DKK 3.9 – 4.1 billion
• EBIT expected at DKK 2.6 – 2.8 billion
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 2
Corporate Release No 730/2022
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
9M 2022
9M 2021
Growth
Q3 2022
Q3. 2021
Growth
Core Revenue
1
13,566
12,246
11%
4,719
4,013
18%
Core EBIT
1
3,372
2,973
13%
1,299
826
57%
Core EPS
1
,
2
2.61
2.10
24%
Core EBIT-margin
1
24.9%
24.3%
27.5%
20.6%
Reported Revenue
13,566
12,246
11%
4,719
4,013
18%
Reported EBIT
2,449
2,004
22%
952
526
81%
Reported EPS
2
1.62
1.33
22%
0.69
0.32
116%
Reported EBIT-margin
18.1%
16.4%
20.2%
13.1%
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 3
Corporate Release No 730/2022
CONTENTS
FINANCIAL HIGHLIGHTS AND KEY FIGURES ..................................................4
MANAGEMENT REVIEW ..............................................................................5
Financial guidance and forward-looking statements .....................................5
Revenue ...............................................................................................5
Expenses and profit ............................................................................. 11
Cash flows .......................................................................................... 13
Financial position ................................................................................. 14
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 2023 ..................................................................... 31
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 4
Corporate Release No 730/2022
FINANCIAL HIGHLIGHTS AND KEY FIGURES
9M 2022
9M 2021
Q3 2022
Q3 2021
FY 2021
Financial highlights (DKK million)
Core revenue
13,566
12,246
4,719
4,013
16,299
Core profit from operations (core EBIT)
3,372
2,973
1,299
826
3,517
Reported revenue
13,566
12,246
4,719
4,013
16,299
Operating profit before depreciation and amortization
(EBITDA)
3,753
3,280
1,414
933
3,720
Reported profit from operations (EBIT)
2,449
2,004
952
526
2,010
Net financials, expenses
392
311
70
114
429
Profit before tax
2,057
1,693
882
412
1,581
Tax
452
373
194
91
263
Profit for the period
1,605
1,320
688
321
1,318
Equity
20,919
18,083
20,919
18,083
18,279
Assets
39,305
35,119
39,305
35,119
34,653
Cash flows from operating and investing activities (free cash
flow)
872
1,557
1,388
1,081
1,662
Purchase of property, plant and equipment, gross
230
244
87
100
410
Key figures
EBITDA-margin (%)
27.7
26.8
30.0
23.2
22.8
Core EBIT margin (%)
24.9
24.3
27.5
20.6
21.6
EBIT margin (%)
18.1
16.4
20.2
13.1
12.3
Return on equity (%)
8.2
7.5
3.4
1.8
7.5
Return on equity (%) – rolling four quarters
8.2
10.8
8.2
10.8
7.5
Return on capital invested (%) – rolling four quarters
8.9
9.9
8.9
9.9
7.9
Net debt/EBITDA (x) – rolling four quarters
0.7
0.8
0.7
0.8
0.9
Share data
Number of shares for the calculation of EPS (millions)
1
992.9
993.3
992.8
993.2
993.3
Number of shares for the calculation of DEPS (millions)
1
992.9
993.3
992.8
993.2
993.3
Earnings per share, basic (EPS) (DKK)
1
1.62
1.33
0.69
0.32
1.33
Earnings per share, diluted (DEPS) (DKK)
1
1.62
1.33
0.69
0.32
1.33
Other
Number of employees (FTE) – end of period
5,452
5,588
5,452
5,588
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 SEPTEMBER 30, 2022 Page 5
Corporate Release No 730/2022
MANAGEMENT REVIEW
Financial guidance and forward-looking statements
Financial guidance
DKK
FY 2021 actual
2022 guidance
Revenue
16,299 million
DKK 17.9 – 18.2 billion
EBITDA
3,720 million
DKK 4.4 – 4.6 billion
Core EBIT
3,517 million
DKK 3.9 – 4.1 billion
Profit from operations (EBIT)
2,010 million
DKK 2.6 – 2.8 billion
Lundbeck’s financial guidance for 2022 which was
raised on November 8, 2022 is maintained.
Lundbeck’s revenue is driven by continued strong
underlying positive momentum in the strategic brands
(Abilify Maintena®, Brintellix®/Trintellix®, Rexulti®
and Vyepti®). Revenue is also benefitting
significantly from the appreciation of Lundbeck’s
main currencies and especially the U.S. Dollar.
Profitability gains due to underlying demand will be
largely offset by hedging effects, normalization of
promotional activity levels and investments in global
development and launch of Vyepti.
Lundbeck has foreign currency risk mainly in USD,
CNY and CAD. The financial guidance for 2022 is
based on the exchange rates by the end of the third
quarter. The hedging rates for the main currencies,
i.e., USD/DKK (6.45), CNY/DKK (1.01) and
CAD/DKK (5.08) and the financial guidance include
an expected hedging loss of approximately DKK 600
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 85 million.
The Russian war against Ukraine has had limited
impact on Lundbeck’s financial results for the first
nine months 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.
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
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 13,566 million in the first nine
months of 2022 compared to DKK 12,246 million in
the first nine months of 2021, representing a growth
of 6% in local currencies (11% reported). The
strategic brands (Abilify Maintena, Brintellix/Trintellix,
Rexulti/Rxulti and Vyepti) grew 30% (+19% in local
currencies) and reached DKK 8,830 million or 65% 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 offset
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 6
Corporate Release No 730/2022
by the negative effect from hedging. Lundbeck’s
biggest markets are the U.S., China, Canada, Spain,
Italy 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 401 million for the first nine
months of 2022, compared to a positive impact of
DKK 78 million for the first nine months of 2021.
Revenue - products and regions
DKK million
9M
2022
9M
2021
Growth
Growth in local
currencies
Q3
2022
Q3
2021
Growth
Growth in local
currencies
Q2
2022
Brintellix/Trintellix
3,177
2,565
24%
15%
1,126
909
24%
13%
1,061
Rexulti
2,817
2,112
33%
19%
1,046
734
43%
23%
940
Abilify Maintena
2,164
1,810
20%
13%
771
613
26%
16%
716
Vyepti
672
328
105%
82%
282
151
87%
60%
220
Strategic brands
8,830
6,815
30%
19%
3,225
2,407
34%
20%
2,937
Cipralex/Lexapro
1,874
1,835
2%
0%
620
600
3%
0%
572
Sabril
482
487
(1%)
(12%)
160
151
6%
(9%)
170
Onfi
317
382
(17%)
(26%)
108
97
11%
(4%)
127
Other pharmaceuticals
2,259
2,438
(7%)
(13%)
756
724
4%
(3%)
691
Other revenue
205
211
(3%)
(4%)
49
58
(16%)
(16%)
91
Effects from hedging
(401)
78
(199)
(24)
(113)
Total revenue
13,566
12,246
11%
6%
4,719
4,013
18%
11%
4,475
United States
6,585
5,533
19%
6%
2,453
1,828
34%
15%
2,214
International Markets
4,023
3,572
13%
5%
1,329
1,185
12%
4%
1,239
Europe
3,154
2,852
11%
11%
1,087
966
13%
12%
1,044
Products
Brintellix/Trintellix (vortioxetine) is Lundbeck’s
largest product and is approved for the treatment of
major depressive disorder (MDD). Sales grew 15% in
local currencies (24% reported) and reached DKK
3,177 million following continued strong demand
especially in markets outside the U.S. The regional
distribution of sales was 37%, 33% and 30% in the
U.S., International Markets and Europe, respectively.
The 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 2,817 million for the first nine months of 2022
representing a growth of 19% in local currencies
(33% reported). The regional distribution of sales was
94%, 5% 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 2,164 million
representing a growth of 13% in local currencies
(20% reported). The regional distribution of sales was
36%, 18% and 46% in the U.S., International Markets
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 7
Corporate Release No 730/2022
and Europe, respectively. The largest markets are the
U.S., Spain, Canada, Australia and Italy.
Vyepti (eptinezumab) doubled in sales and reached
sales of DKK 672 million in the first nine months of
2022 compared to the same period last year mainly
following strong demand. The product is approved in
around 40 markets including the U.S., Australia,
Canada and Europe for the preventive treatment of
migraine in adults. Vyepti was launched in April 2020
in the U.S. and it has since been launched in
Australia, Finland, Germany, Kuwait, Singapore,
Switzerland and United Arab Emirates (U.A.E.) For
the remainder of 2022, Vyepti is expected to be
launched in around 5 markets.
Cipralex
®
/Lexapro
®
(escitalopram) is approved for
the treatment of MDD. Sales reached DKK 1,874
million in the first nine months of 2022. 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 2,259 million compared to DKK 2,438
million in the first nine months of 2021 following lower
sales of mature products such as Northera. Northera
lost exclusivity in February 2021 and is reported
together with Other pharmaceuticals. Sales of
Northera reached DKK 361 million compared to DKK
536 million in the first nine months 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 205 million compared
to DKK 211 million in the first nine months of 2021.
Figure 1 – Revenue per region 9M 2022 vs 9M 2021 (excluding Other revenue and Effects from hedging)
Key developments in the third quarter of 2022
In the third quarter of 2022, revenue reached DKK
4,719 million compared to DKK 4,013 million in 2021.
The strategic brands grew by 20% in local currencies
(+34% reported) for the period, thereby reaching DKK
3,225 million or 68% of total revenue.
United States
Revenue reached DKK 6,585 million in the first nine
months of 2022 compared to DKK 5,533 million for
the same period in 2021. The strategic brands
increased by 17% in local currency (33% reported)
and reached DKK 5,237 million or 80% of sales. The
sales growth was driven by strong demand but also
positively impacted by the appreciation of the USD.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 8
Corporate Release No 730/2022
Revenue – United States
DKK million
9M
2022
9M
2021
Growth
Growth in local
currencies
Q3
2022
Q3
2021
Growth
Growth in local
currencies
Q2
2022
Rexulti
2,636
1,982
33%
18%
983
688
43%
23%
879
Trintellix
1,178
1,036
14%
0%
442
379
17%
(2%)
387
Abilify Maintena
766
607
26%
12%
279
209
33%
14%
255
Vyepti
657
327
101%
78%
270
150
80%
55%
220
Strategic brands
5,237
3,952
33%
17%
1,974
1,426
38%
18%
1,741
Sabril
482
487
(1%)
(12%)
160
151
6%
(9%)
170
Onfi
317
382
(17%)
(26%)
108
97
11%
(4%)
127
Other pharmaceuticals
549
712
(23%)
(31%)
211
154
37%
19%
176
Total revenue
6,585
5,533
19%
6%
2,453
1,828
34%
15%
2,214
Products
Rexulti is Lundbeck’s largest product in the U.S.
Lundbeck’s share of revenue reached DKK 2,636
million following a growth of 18% in local currency
(33% reported). Rexulti has a stable volume market
share of 2.3% by July 2022 (source: IQVIA). Patient
data suggest that more than 3/4 of prescriptions are
for major depression (MDD).
Trintellix sales reached DKK 1,178 million in
revenue for Lundbeck representing a growth of nil in
local currency (14% reported). Prescribing dynamics
in the MDD market in the US have changed following
the pandemic which may be attributed to several
factors including the continued increased use of
telehealth among psychiatrists, lower impact on
generics from the pandemic compared to branded
products and medications for adjunct MDD and total
NBRx that remains at a lower level for the total market
than pre-pandemic. While Lundbeck and our partner
Takeda have optimized the promotional efforts for
Trintellix to a lower level over recent years we are
actively addressing the changed prescribing patterns
in the US. The volume market share has been stable
around 0.9% by July 2022 (source: IQVIA). The value
market share of the total anti-depressant market has
increased from 24.2% by January 2021 to 30.0% by
July 2022 (source: IQVIA).
Abilify Maintena revenue reached DKK 766 million,
representing Lundbeck’s share of total net sales.
Abilify Maintena has a stable volume market share of
around 23% by July 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 657 million in the
first nine months of 2022 compared to the first nine
months of 2021.
Sabril
®
revenue is stable and reached DKK 482
million and Onfi
®
revenue reached DKK 317 million.
In Other pharmaceuticals, Northera sales reached
DKK 361 million for the period compared to DKK 536
million for the same period last year following the
launch of several generic versions in February 2021.
Key developments in the third quarter of 2022
In the third quarter of 2022, revenue reached DKK
2,453 million compared to DKK 1,828 million for the
same period last year. The strategic brands grew by
18% in local currency (+38% reported) for the period
thereby reaching DKK 1,974 million or 80% of total
revenue. Trintellix declined by 2% in local currency
(+17% reported) as a consequence of continued
general lower brand prescriptions post-COVID19 and
also reduced promotion efforts as Lundbeck and
Takeda have adjusted their commercial organization.
International Markets
Revenue from International Markets, which as of
January 1, 2022, also includes Canada (see note 1
Accounting policies) and therefore comprises all
Lundbeck’s markets outside of Europe and the U.S.,
reached DKK 4,023 million in the first nine months of
2022. The revenue growth of 5% in local currencies
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 9
Corporate Release No 730/2022
(13% reported) was mainly driven by Brintellix and
Rexulti. The biggest markets are China, Canada,
Japan, Brazil and Australia. China and Japan
constitute approximately 33% of regional revenue.
The strategic brands increased by 25% in local
currencies (+35% reported) and reached DKK 1,592
million or 40% of sales.
Revenue – International Markets
DKK million
9M
2022
9M
2021
Growth
Growth in local
currencies
Q3
2022
Q3
2021
Growth
Growth in local
currencies
Q2
2022
Brintellix
1,034
752
38%
28%
349
269
30%
20%
345
Abilify Maintena
397
314
26%
17%
148
103
44%
28%
131
Rexulti
151
110
37%
26%
53
37
43%
30%
52
Vyepti
10
1
900%
800%
7
1
600%
500%
-
Strategic brands
1,592
1,177
35%
25%
557
410
36%
24%
528
Cipralex/Lexapro
1,361
1,316
3%
(1%)
444
417
6%
1%
406
Other pharmaceuticals
1,070
1,079
(1%)
(8%)
328
358
(8%)
(16%)
305
Total revenue
4,023
3,572
13%
5%
1,329
1,185
12%
4%
1,239
Products
Brintellix/Trintellix is Lundbeck’s second largest
product in the region. Sales reached DKK 1,034
million or an increase of 28% in local currencies
(+38% reported). Brintellix realized solid growth
across several markets including Japan, China,
Brazil and Canada, but the growth is also impacted
by quarterly fluctuations in shipments. 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 7.5% and 9.1%,
respectively by September 2022 (source: IQVIA). In
December 2021, Trintellix had a value share of 5.8%.
Brintellix is not included in the National
Reimbursement Drug List (NRDL) in China and is not
reimbursed, but the product is showing strong growth.
Abilify Maintena reached DKK 397 million in
revenue representing a growth of 17% in local
currencies (+26% 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 31% and in Canada, it
has reached 34.1% by July 2022 (source: IQVIA).
Countries such as Saudi Arabia, U.A.E. and Kuwait
also contributed positively.
Rexulti reached DKK 151 million in sales and grew
by 26% in local currencies. In International Markets,
the product has its highest sales in Canada followed
by Brazil and Australia. In Canada, Rexulti’s volume
share has reached 3.2% by July 2022 unchanged
compared to 3.2% in December 2021 (source:
IQVIA). In Australia, Rexulti has maintained a market
share of around 2.2% in volume by July 2022 (source:
IQVIA). In Brazil, Rexulti has reached a volume share
of 1.8% compared to 1.6% by December 2021
(source: IQVIA) and most of the product growth in the
region came from Brazil during the period.
Vyepti was launched 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 including Canada are planned for
the remainder of 2022. Sales reached DKK 10 million
in the first nine months of 2022. In the U.A.E., Vyepti
has achieved a 13% volume market share among all
CGRP products in the market (source: IQVIA).
Cipralex/Lexapro continues to be Lundbeck’s
largest product in the region. The product generated
revenue of DKK 1,361 million representing a growth
of 3% (down 1% 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 SEPTEMBER 30, 2022 Page 10
Corporate Release No 730/2022
Other pharmaceuticals generated revenue of DKK
1,070 million. Azilect is promoted by Lundbeck in
some countries in Asia. Azilect generated revenue of
DKK 146 million while Ebixa generated revenue of
DKK 329 million.
Key developments in the third quarter of 2022
In the third quarter of 2022, revenue increased 4% in
local currencies (+12% reported) and reached DKK
1,329 million. The strategic brands grew by 24% in
local currencies (+36% reported) for the period,
thereby reaching DKK 557 million or 42% of total
revenue.
Europe
Revenue reached DKK 3,154 million in the first nine
months of 2022 compared to DKK 2,852 million in
2021, which represents a growth of 11%. In general,
Europe continues to realize very robust underlying
demand countering a continuous negative average
price development and continued generic erosion on
the mature product portfolio. The strategic brands
increased by 18% in local currencies (+19% reported)
and reached DKK 2,001 million or 63% of sales. The
largest markets in Europe are Spain, Italy, France,
Switzerland and Greece.
Revenue – Europe
DKK million
9M
2022
9M
2021
Growth
Growth in local
currencies
Q3
2022
Q3
2021
Growth
Growth in local
currencies
Q2
2022
Abilify Maintena
1,001
889
13%
12%
344
301
14%
14%
330
Brintellix
965
777
24%
24%
335
261
28%
27%
329
Rexulti/Rxulti
30
20
50%
45%
10
9
11%
11%
9
Vyepti
5
-
-
-
5
-
-
-
-
Strategic brands
2,001
1,686
19%
18%
694
571
22%
20%
668
Cipralex
513
519
(1%)
1%
176
183
(4%)
(3%)
166
Other pharmaceuticals
640
647
(1%)
(1%)
217
212
2%
1%
210
Total revenue
3,154
2,852
11%
11%
1,087
966
13%
12%
1,044
Products
Abilify Maintena is Lundbeck’s largest product in the
region. Sales uptake of Abilify Maintena is robust with
revenue reaching DKK 1,001 million, a growth of 12%
in local currencies compared to the first nine months
of 2021. 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 July 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 24% reaching DKK 965
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 13.4%, 11.0% and 11.4%, respectively by
July 2022 (source: IQVIA). The volume shares have
increased to around 4.9%, 4.3% and 4.6%,
respectively (source: IQVIA).
Rexulti/Rxulti revenue reached DKK 30 million
following a growth of 45% in local currencies. The
product was launched in Italy in 2021 where it has a
stable volume share of around 0.7% by July 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 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
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 11
Corporate Release No 730/2022
2019 was met. The amount payable by Lundbeck to
the CVR holders was totaling approximately USD 230
million (DKK ~1.5 billion) and was paid in the first
quarter of 2022. Vyepti is now launched in Finland,
Germany and Switzerland. Lundbeck plans to launch
in additional markets in EU in 2022 and many more
markets from 2023 and onwards following pricing and
market access discussions in each market. Sales
reached DKK 5 million in the first nine months of
2022. Early launch experiences from the markets
indicate that the launches are going well and in
Switzerland where the product was first launched in
Europe the volume market share among the CGRP
products have reached almost 4%.
Cipralex generated revenue of DKK 513 million in the
first nine months of 2022. The product has been quite
resilient. Sales are generally also impacted by
quarterly fluctuations.
Revenue from Other pharmaceuticals was DKK
640 million, a decline of 1% in local currencies
compared to 2021, as a result of continued generic
erosion of mature products.
Key developments in the third quarter of 2022
In the third quarter of 2022, revenue increased by
12% in local currencies (+13% reported) and reached
DKK 1,087 million compared to DKK 966 million for
the same period in 2021. The strategic brands grew
by 20% in local currencies for the period, thereby
reaching DKK 694 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 nine months of 2022, total costs increased
by 9% to DKK 11,117 million compared to DKK
10,242 million for the same period in 2021. Revenue
increased 11% in the same period.
Distribution of costs
DKK million
9M 2022
9M 2021
Growth
Q3 2022
Q3 2021
Growth
Q2 2022
Cost of sales
2,772
2,648
5%
961
851
13%
966
COS-ratio
20.4%
21.6%
20.4%
21.2%
21.6%
Sales and distribution costs
4,740
4,103
16%
1,653
1,391
19%
1,652
S&D-ratio
34.9%
33.5%
35.0%
34.7%
36.9%
Administrative expenses
756
663
14%
247
238
4%
273
G&A-ratio
5.6%
5.4%
5.2%
5.9%
6.1%
Research & development costs
2,849
2,828
1%
906
1,007
(10%)
962
R&D-ratio
21.0%
23.1%
19.2%
25.1%
21.5%
Total costs
11,117
10,242
9%
3,767
3,487
8%
3,853
Cost of sales increased by 5% to DKK 2,772 million
in the first nine months of 2022 and the gross margin
was 79.6% compared to 78.4% for the same period
in 2021. The increase in gross margin was impacted
by product mix and reduced royalty costs on the
mature neurology products in the U.S partially offset
by FX appreciation and slightly higher utility costs due
to inflation. Part of cost of sales relates to
amortization of product rights which was DKK 971
million for the period compared to DKK 969 million for
the same period in 2021. Core gross margin
increased from 86.3% to 86.7%.
Sales and distribution costs were DKK 4,740
million in the first nine months of 2022, an increase of
16% compared to the same period in 2021 driven by
FX appreciation and generally increasing activity
level especially for Vyepti development and launch
preparation and patient activation programs in the
U.S. Sales and distribution costs corresponded to
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 12
Corporate Release No 730/2022
34.9% of revenue in the first nine months of 2022,
compared to 33.5% for the same period in 2021.
Administrative expenses compared to 2021
increased by 14% to DKK 756 million, corresponding
to 5.6% of total revenue. The increase is mainly a
result of cloud-based software that is recognized
directly in the income statement, FX development
and a donation to Red Cross communicated in the
financial report for the first half of 2022.
Research & development costs were DKK 2,849
million in the first nine months of 2022 with an R&D
ratio of 21.0%. R&D costs are mainly impacted by
timing of payments and the completion of phase IV
study on vortioxetine.
Total operational costs (OPEX) reached DKK 8,345
million in the first nine months of 2022 compared to
DKK 7,594 million the same period in 2021
corresponding to an increase of 10%.
Key developments in the third quarter of 2022
In the third quarter of 2022, total costs amounted to
DKK 3,767 million, representing an increase of 8%
compared to 2021. Core gross margin increased
from 86.3% to 87.0%.
Depreciation, amortization and impairment
losses
Depreciation, amortization and impairment losses,
which are included in the individual expense
categories, amounted to DKK 1,304 million in the first
nine months of 2022 compared to DKK 1,276 million
in 2021 driven by FX and increased Vyepti
amortizations.
Amortization of product rights was DKK 971 million in
the first nine months of 2022 compared to DKK 969
million in 2021.
Depreciation, amortization and impairment charges
DKK million
9M 2022
9M 2021
Growth
Q3 2022
Q3 2021
Growth
Q2 2022
Cost of sales
1,150
1,111
4%
409
348
18%
373
Sales and distribution cost
77
71
8%
30
24
25%
24
Administrative expenses
12
22
(45%)
4
11
(64%)
4
Research & development costs
65
72
(10%)
19
24
(21%)
26
Total depreciation, amortization
and impairment charges
1,304
1,276
2%
462
407
14%
427
EBITDA and Profit from operations (EBIT
and core EBIT)
Following the solid growth in revenue and prudent
cost spend, EBITDA increased 14% thereby
reaching DKK 3,753 million. EBITDA-margin
increased from 26.8% to 27.7%.
Reported EBIT grew by 22% thereby reaching DKK
2,449 million in the first nine months of 2022. The
EBIT margin reached 18.1% for the period compared
to 16.4% the same period in 2021. Core EBIT
increased by 13% to DKK 3,372 million compared to
the same period in 2021 and Core EBIT margin was
24.9% compared to 24.3% in 2021.
In the third quarter of 2022, EBITDA reached DKK
1,414 million representing a growth of 52% compared
to the same period in 2021 due to lower R&D costs
and slower growth in administration costs in the
quarter. The EBITDA margin increased from 23% to
30%. EBIT reached DKK 952 million and Core EBIT
reached DKK 1,299 million. The Core EBIT margin
increased from 20.6% to 27.5%.
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
392 million for the first nine months of 2022 compared
to a net financial expense of DKK 311 million for the
first nine months of 2021.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 13
Corporate Release No 730/2022
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 in the first
quarter of 2022, along with interest costs on the debt
portfolio (including interest rate swaps), and banking
costs.
Tax
The effective tax rate for the first nine months of 2022
is 22.0%. The tax rate is negatively impacted by the
non-deductible CVR payment regarding Vyepti EMA
approval but offset by the Danish research and
development incentive.
Profit and EPS
Profit reached DKK 1,605 million for the first nine
months of 2022 compared to DKK 1,320 million for
the same period in 2021. The reported net profit
corresponded to an EPS of DKK 1.62 versus an EPS
of DKK 1.33 in 2021. Core EPS reached DKK 2.61 in
the first nine months of 2022, compared to a Core
EPS of DKK 2.10 in 2021. 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 2,232 million in the first 9 months of
2022 compared to an inflow of DKK 1,889 million in
the first nine months of 2021. The development
compared to 2021 is impacted by higher EBITDA,
offset 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 1,360 million in the
first nine months of 2022 compared to an outflow of
DKK 332 million in the first 9 months of 2021. In 2022,
the cash flow was driven by the payment of
contingent consideration related to the EMA approval
of Vyepti and CAPEX investments.
The cash flows from financing activities were an
inflow of DKK 169 million in the first nine months of
2022 compared to an outflow of DKK 2,995 million in
the first nine months 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 nine months of 2022, the net cash inflow
reached DKK 1,041 million compared to an outflow of
DKK 1,438 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
9M 2022
9M 2021
Q3 2022
Q3 2021
Profit from operations (EBIT)
2,449
2,004
952
526
Cash flows from operating activities
2,232
1,889
1,521
1,219
Cash flows from investing activities
(1,360)
(332)
(133)
(138)
Cash flows from operating and investing
activities (free cash flow)
872
1,557
1,388
1,081
Cash flows from financing activities
169
(2,995)
(311)
(272)
Net cash flow for the period
1,041
(1,438)
1,077
809
QUARTERLY RELEASE FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022
Corporate Release No 730/2022
Financial position
At September 30, 2022, Lundbeck’s total assets
amounted to DKK 39,305 million compared to DKK
34,653 million at the end of 2021.
At September 30, 2022, Lundbeck's equity
amounted to DKK 20,919 million, corresponding to an
equity ratio of 53.2% compared to 52.7% at the end
of 2021.
Net debt has been reduced from DKK 3,214 million
at the end of September 2021 to DKK 3,021 million at
September 30, 2022. Interest bearing debt was
DKK 6,427 million at the end of September 2022
compared to DKK 5,718 million at the end of
September 2021. Interest bearing debt is driven by
drawings on loans, higher cash balance and loans
partly being USD-denominated.
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) Two phase III clinical trials, supporting registration in Asia, including China and Japan: 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
DKK million
9M 2022
9M 2021
FY 2021
Total assets
39,305
35,119
34,653
Lundbeck’s share of equity
20,919
18,083
18,279
Net-interest bearing debt
3,021
3,214
3,189
Invested capital, end of period
15,365
13,822
13,185
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
6)
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 SEPTEMBER 30, 2022 Page 15
Corporate Release No 730/2022
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),
Israel (December 2021), Great Britain (January
2022), Brazil (February 2022), Indonesia (May 2022),
Mexico (July 2022), Saudi Arabia (August 2022) and
Hong Kong (September 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. 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.
Based on the outcome of the SUNLIGHT trial,
Lundbeck is increasing the sample size of the
SUNRISE trial.
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.
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.
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Corporate Release No 730/2022
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.
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,
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 Lu AG09222 high dose, low
dose, or placebo. The study has completed
enrollment.
Circuitry / neuronal biology:
Brexpiprazole – phase III in Alzheimer’s agitation
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
by the investigator as not related to treatment.
Based on this outcome, Lundbeck and Otsuka are
planning a regulatory filing to the FDA in the fourth
quarter of 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 the
treatment of agitation in patients with Alzheimer’s
dementia.
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,
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 17
Corporate Release No 730/2022
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.
In November 2018, Lundbeck and Otsuka
Pharmaceutical reported data from an explorative
phase II study in PTSD, with positive findings from the
treatment arm that examined a combination
treatment of brexpiprazole and sertraline. 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 was
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. Given the
obtained FDA guidance, the program will continue,
however with reduced sample size and with
estimated headline results in the second half of 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 have
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
and Health Canada for the treatment of schizophrenia
and bipolar disorder. The MAA was submitted May
26, 2022. The U.S. NDA was submitted June 27,
2022 – PDUFA date April 27, 2023.
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).
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
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 18
Corporate Release No 730/2022
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 neurodegenerative
diseases such as multiple system atrophy (MSA),
Parkinson’s disease (PD), and other
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 and 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) and is presently
ongoing in the U.S. and Japan. The primary objective
of the study is to evaluate the efficacy of Lu AF82422
versus placebo on disease progression in patients
with MSA.
A natural history study (TALISMAN) for early MSA
patients has been initiated in China in June 2022, and
opened for recruitment in the EU (France, Germany,
Italy) in October 2022.
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
CD40L/serum-albumin bispecific antibody-fragment
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. A First-in-Human study
(NCT05136053) testing single ascending doses of Lu
AG22515 in healthy volunteers was initiated in the
U.S. in March 2022.
Sustainability update
Climate and energy
In the first nine months of 2022, energy consumption
decreased by 0.8% compared to same period last
year. This is attributed to energy reduction initiatives
at the Padova site (Italy) and the Valby site
(Denmark).
GHG emissions from our sites have increased by
15% due to limited supply of biooil leading to
increased consumption of gasoil. However, our
overall Scope 1 emissions decreased by 7% due to a
15% decrease in emissions from our company cars
which constitute 2/3 of our Scope 1 GHGs.
Scope 2 GHG emissions have decreased by 69%
due to the power purchase agreement supplying the
Danish sites with renewable solar electricity since the
start of the year. In total we have achieved a 17%
reduction in Scope 1 and 2 GHG emissions.
Health & Safety
The number of work-related accidents with absence
is 17 in the first nine months of 2022, the same as in
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 19
Corporate Release No 730/2022
2021, giving a frequency of 6.3 which is above our
target of 5.0. Three of the 17 accidents are
categorized as high consequence, which means that
the employee is not expected to recover fully to pre-
injury health status within six months. Our target is to
have no more than 4 such accidents per year. One
third of all the accidents are related to ergonomic and
back injuries. Action plans are in place to minimize
accidents and risks on all sites, including retraining in
lifting techniques.
Business Ethics
62 new Compliance Hotline reports were received in
the first nine months of 2022. The increase compared
to the same period last year is largely attributed to an
update in the accounting policies 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. 23 cases would have
been reported so far in 2022 if the accounting policies
had not been updated, this is compared to 15 cases
in the same period in 2021.
In the first nine months of 2022, Due Diligence
assessments of 102 potential third parties were
conducted, which identified 9 potential cases where
one of more issues will be mitigated and monitored if
the collaboration agreement is executed. This is
compared to 99 assessments conducted in the first
nine months of 2021.
Lundbeck’s annual Code of Conduct training has
been prepared in the third quarter of 2022, to be
launched companywide in fourth quarter of 2022.
Under the theme of ‘Doing the right thing’, the training
covers key aspects of the Code of Conduct such as
anticorruption and bribery, social media, HCP
interactions and data privacy. The training is
mandatory for all to complete and we report on the
completion rate in our annual sustainability report.
Sustainability Key Performance Indicators
Category
9M 2022
9M 2021
Change (%)
Energy consumption (MWh)
1
78,180
78,825
(0.8%)
Scope 1 GHGs (Tonne CO
2-
e)
16,965
18,194
(7.2%)
Scope 2 GHGs – market based (Tonne CO
2-
e)
3,328
5,638
(69%)
Scope 1+2 GHGs (Tonne CO
2-
e)
20,293
23,832
(17%)
Frequency of lost time accidents (Frequency)
6.3
6.3
0%
Work-related accidents with absence (Number)
17
17
0%
Compliance Hotline reports (Number)
2
62
16
N/A
Due Diligence screenings of suppliers and third parties (Number)
102
99
2.9%
Note: See Lundbeck Sustainability Report 2021 for accounting policies and definitions
1 The 2021 energy consumption data updated
2 Update in accounting policies for number of Compliance Hotline reports
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
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
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 20
Corporate Release No 730/2022
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. In early
October 2022 Lundbeck received a required 8 weeks’
notice, which means that the UK health authorities
may submit its claim to the court after 25 November
2022. 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
first defense in May 2022 and the parties have
subsequently exchanged additional pleadings. It may
take several years before a final conclusion is
reached by the German courts. Finally, in March and
April 2022 Lundbeck received letters from several
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
“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
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 21
Corporate Release No 730/2022
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 (brexpiprazole) in the U.S. The proceedings
have now been resolved. The compound patent
remains valid until June 23, 2029, including expected
pediatric extensions.
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 Otsuka and Lundbeck 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 United States 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 SEPTEMBER 30, 2022 Page 22
Corporate Release No 730/2022
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 September 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 September 30, 2022, and of the results of the
Group’s operations and cash flows for the period, which ended on September 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 SEPTEMBER 30, 2022 Page 23
Corporate Release No 730/2022
CONDENSED FINANCIAL STATEMENTS
Condensed statement of profit or loss
DKK million
9M 2022
9M 2021
Q3 2022
Q3 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
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
9M 2022
9M 2021
Q3 2022
Q3 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
Exchange rate gains/losses on additions to net investments in
foreign subsidiaries
(69 )
(103 )
(21 )
(18 )
(157 )
Hedging of net investments in foreign subsidiaries
(295 )
(104 )
(127 )
(37 )
(127 )
Deferred gains/losses on cash flow hedge, exchange rate
(739 )
(206 )
(331 )
(65 )
(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)
(78 )
(53 )
Tax
Items that may be reclassified subsequently to profit or loss
Other comprehensive income
Comprehensive income
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 24
Corporate Release No 730/2022
Condensed statement of financial position
DKK million
30.09.2022
30.09.2021
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
(243 )
(91 )
(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 SEPTEMBER 30, 2022 Page 25
Corporate Release No 730/2022
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
(81 )
Comprehensive income
(81 )
Distributed dividends, gross
(398 )
(398 )
Dividends received, treasury shares
Buyback of treasury shares
(45 )
(45 )
Incentive programs
Tax on other transactions in equity
Other transactions
(422 )
(422 )
Equity at September 30, 2022
(243 )
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
(186 )
Comprehensive income
(186 )
Distribution of dividends, gross
(498 )
(498 )
Dividends received, treasury shares
Buyback of treasury shares
(34 )
(34 )
Incentive programs
Tax on other transactions in equity
Other transactions
(501 )
(501 )
Equity at September 30, 2021
(91 )
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 26
Corporate Release No 730/2022
Condensed statement of cash flows
DKK million
9M 2022
9M 2021
Q3 2022
Q3 2021
FY 2021
Profit from operations (EBIT)
Adjustments for non-cash items
Change in working capital
(691 )
(214 )
(305 )
Cash flows from operations before financial receipts and
payments
Financial receipts and payments
(484 )
(30 )
(132 )
Cash flows from ordinary activities
Income taxes paid
(152 )
(507 )
(34 )
(203 )
(449 )
Cash flows from operating activities
Contingent consideration pmt. from acquisitions of company
(1,076 )
Purchase and sale of intangible assets and property, plant and
equipment
(284 )
(332 )
(133 )
(138 )
(610 )
Cash flows from investing activities
(1,360 )
(332 )
(133 )
(138 )
(610 )
Cash flows from operating and investing activities
(free cash flow)
Proceeds from loans and issue of bonds
Repayment of bank loans and borrowings
(552 )
(2,802 )
(286 )
(250 )
(3,123 )
Dividends paid in the financial year, net
(397 )
(497 )
(497 )
Other financing activities
(116 )
(96 )
(25 )
(22 )
(116 )
Cash flows from financing activities
(2,995 )
(311 )
(272 )
(3,336 )
Net cash flow for the period
(1,438 )
(1,674 )
Cash and bank balances at beginning of period
Unrealized exchange gains/losses on cash and bank balances
Net cash flow for the period
(1,438 )
(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
(6,427 )
(5,718 ) (6,427 )
(5,718 )
(5,468 )
Net cash/(net debt)
(3,021 )
(3,214 ) (3,021 )
(3,214 )
(3,189 )
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 27
Corporate Release No 730/2022
Statement of profit or loss – Core results reconciliation (9M)
9M 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
13,566
-
-
-
-
-
-
13,566
Cost of Sales
2,772
(971)
-
-
-
-
-
1,801
Gross profit
10,794
971
-
-
-
-
-
11,765
Sales and distribution costs
4,740
-
-
43
-
-
-
4,783
Administrative expenses
756
-
-
-
-
-
-
756
Research and development costs
2,849
-
-
5
-
-
-
2,854
Profit from operations (EBIT)
2,449
971
-
(48)
-
-
-
3,372
Net financials, expenses
392
-
-
-
-
-
(278)
114
Profit before tax
2,057
971
-
(48)
-
-
278
3,258
Tax on profit for the period
452
224
-
(10)
-
-
-
666
Profit for the period
1,605
747
-
(38)
-
-
278
2,592
Earnings per share, basic (EPS)
1.62
0.75
-
(0.04)
-
-
0.28
2.61
9M 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
12,246
-
-
-
-
-
-
12,246
Cost of sales
2,648
(969)
-
-
-
-
-
1,679
Gross profit
9,598
969
-
-
-
-
-
10,567
Sales and distribution costs
4,103
-
-
-
-
-
-
4,103
Administrative expenses
663
-
-
-
-
-
-
663
Research and development costs
2,828
-
-
-
-
-
-
2,828
Profit from operations (EBIT)
2,004
969
-
-
-
-
-
2,973
Net financials, expenses
311
-
-
-
-
-
-
311
Profit before tax
1,693
969
-
-
-
-
-
2,662
Tax on profit for the period
373
206
-
-
-
-
-
579
Profit for the period
1,320
763
-
-
-
-
-
2,083
Earnings per share, basic (EPS)
1
1.33
0.77
-
-
-
-
-
2.10
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 SEPTEMBER 30, 2022 Page 28
Corporate Release No 730/2022
Statement of profit or loss – Core results reconciliation (Q3)
Q3 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
4,719
-
-
-
-
-
-
4,719
Cost of Sales
961
(347)
-
-
-
-
-
614
Gross profit
3,758
347
-
-
-
-
-
4,105
Sales and distribution costs
1,653
-
-
-
-
-
-
1,653
Administrative expenses
247
-
-
-
-
-
-
247
Research and development costs
906
-
-
-
-
-
-
906
Profit from operations (EBIT)
952
347
-
-
-
-
-
1,299
Net financials, expenses
70
-
-
-
-
-
-
70
Profit before tax
882
347
-
-
-
-
-
1,229
Tax on profit for the period
194
80
-
-
-
-
-
274
Profit for the period
688
267
-
-
-
-
-
955
Earnings per share, basic (EPS)
0.69
0.27
-
-
-
-
-
0.96
Q3 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
4,013
-
-
-
-
-
-
4,013
Cost of sales
851
(300)
-
-
-
-
-
551
Gross profit
3,162
300
-
-
-
-
-
3,462
Sales and distribution costs
1,391
-
-
-
-
-
-
1,391
Administrative expenses
238
-
-
-
-
-
-
238
Research and development costs
1,007
-
-
-
-
-
-
1,007
Profit from operations (EBIT)
526
300
-
-
-
-
-
826
Net financials, expenses
114
-
-
-
-
-
-
114
Profit before tax
412
300
-
-
-
-
-
712
Tax on profit for the period
91
69
-
-
-
-
-
160
Profit for the period
321
231
-
-
-
-
-
552
Earnings per share, basic (EPS)
1
0.32
0.24
-
-
-
-
-
0.56
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 SEPTEMBER 30, 2022 Page 29
Corporate Release No 730/2022
Notes
Note 1: Accounting policies
The interim condensed consolidated financial statements for the nine months ended September 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)
September 30, 2022:
Financial assets
Other financial assets
1
50
-
31
Derivatives
1
-
306
188
Total
50
306
219
Financial liabilities
Contingent consideration
1
-
-
473
Derivatives
1
-
798
Bank debt²
-
2,060
-
Bond debt²
3,142
-
-
Total
3,142
2,858
473
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 debt²
-
1,083
-
Bond debt²
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 SEPTEMBER 30, 2022 Page 30
Corporate Release No 730/2022
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 320 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 473 million at September 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 96 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
9M 2022
9M 2021
Q3 2022
Q3 2021
FY 2021
EBIT
2,449
2,004
952
526
2,010
+ Depreciation, amortization and impairment losses
1,304
1,276
462
407
1,710
= EBITDA
3,753
3,280
1,414
933
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
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 31
Corporate Release No 730/2022
Legal fees and settlements, including:
• 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 2023
February 6, 2023: Deadline for the company’s receipts of shareholder proposals for the Annual General
Meeting 2023
February 8, 2023: Financial statements for the full year 2022
February 8, 2023: Annual Report 2022 (PDF)
March 21, 2023: Lundbeck Annual General Meeting 2022
March 24, 2023: Dividends for 2022 at the disposal of shareholders
May 10, 2023: Financial statements for the first three months of 2023
August 16, 2023: Financial statements for the first six months of 2023
November 8, 2023: Financial statements for the first nine months of 2023
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
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2022 Page 32
Corporate Release No 730/2022
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.