CORPORATE RELEASE
NOVEMBER 8, 2023
Corporate Release No 747/2023
Financial report for the period January 1 to September 30, 2023
Lundbeck's revenue in the first nine months of 2023 climbed to
DKK 15 billion
Key highlights
Lundbeck’s revenue increased by 10% (+9% CER
1
) to DKK 14,934 million in the first nine months of 2023, driven
mainly by growth in the U.S. and Europe
• United States: DKK 7,317 million (+11%; +13% CER)
• Europe: DKK 3,454 million (+10%; +11% CER)
• International Markets: DKK 3,926 million (-2%; +3% CER)
The revenue of Lundbeck’s strategic brands increased by 14% (+16% CER), reaching DKK 10,091 million,
representing 68% of total revenue
• Rexulti
®
/Rxulti
®
: DKK 3,309 million (+17%; +19% CER)
• Brintellix
®
/Trintellix
®
: DKK 3,207 million (+1%; +4% CER)
• Abilify Maintena
®
/Asimtufii: DKK 2,374 million (+10%; +11% CER)
• Vyepti
®
: DKK 1,201 million (+79%; +81% CER)
Adjusted EBITDA
2
increased to DKK 4,859 million (+31%; +20% CER) and adjusted EBITDA margin reached 32.5%
equivalent to an increase of 5.2 percentage points. Adjusted earnings per share (EPS) reached DKK 3.65 equivalent
to an increase of 27%.
In connection with the corporate release, Lundbeck’s President and CEO, Charl van Zyl said:
“In my first two months at Lundbeck, I have witnessed a highly skilled team and a solid foundation for advancing
the company's objectives of long-term growth. Lundbeck has strong momentum and is delivering a robust
performance, achieving a revenue of DKK 15 billion in the first nine months, and allowing for a slight guidance
upgrade. We are committed to investing in our pipeline, building upon a successful R&D transformation for the
company's future progress.”
Key figures
1
Constant Exchange Rates (CER) previously denominated Local Currency (LC). Change at CER does not include effects from hedging.
2
EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization. Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see section
4 Notes, note 3 Adjusted EBITDA.
DKK million
9M 2023
9M 2022
Change
Change
(CER)
1
Q3 2023
Change
(CER)
1
Revenue
14,934
13,566
10%
9%
4,952
7%
EBITDA
4,463
3,753
19%
9%
1,385
(7%)
Adjusted EBITDA
4,859
3,705
31%
20%
1,521
1%
EPS (DKK)
2.17
1.62
34%
0.68
Adjusted EPS (DKK)
3.65
2.87
27%
1.17
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 2
Corporate Release No 747/2023
Recent events
On September 1, 2023, Charl van Zyl joined as new President and CEO of Lundbeck as announced on June 26,
2023.
On September 7, 2023, Lundbeck and Otsuka Pharmaceutical, Co., Ltd. announced topline results from two phase
III trials of brexpiprazole as combination therapy with sertraline for the treatment of Post-Traumatic Stress Disorder
in adults. Overall, the safety and tolerability results were consistent with the profile of brexpiprazole as observed in
the clinical trials for schizophrenia, agitation associated with dementia due to Alzheimer’s disease (AADAD), and
adjunctive treatment of major depressive disorder (MDD).
On September 14, 2023, Lundbeck presented clinical data from a phase IIa Proof of Concept trial on Lu AG09222
in migraine prevention at the International Headache Congress in Seoul, Korea. The data supports Lu AG09222 as
a potential preventive treatment of migraine and based on this positive outcome. Lu AG09222 is progressing into
further trials to expand its route of administration opportunities and dose-response relationship.
2023 Guidance
Lundbeck has narrowed its full-year guidance for revenue and now expects revenue to reach DKK 19.8 to 20.1
billion compared to previously DKK 19.5 to 20.1 billion. The financial guidance for Adjusted EBITDA has been
narrowed and raised due to lower than expected R&D costs. Adjusted EBITDA is now expected to reach DKK 5.6
to 5.8 billion compared to previously DKK 5.2 to 5.6 billion. Further details are available in section 2.8 Outlook.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 3
Corporate Release No 747/2023
CONTENT
1 Financial highlights ................................................................................................................................................ 4
2 Business performance ........................................................................................................................................... 5
2.1 Revenue by product ....................................................................................................................................... 5
2.2 Revenue by geographical area ...................................................................................................................... 7
2.3 Gross profit ..................................................................................................................................................... 8
2.4 EBIT and adjusted EBITDA ............................................................................................................................ 9
2.5 Net profit and adjusted EPS ......................................................................................................................... 10
2.6 Cash flow and balance sheet ....................................................................................................................... 10
2.7 Summary of the key developments in the third quarter of 2023 ................................................................... 11
2.8 Outlook ......................................................................................................................................................... 13
2.9 Lundbeck’s development portfolio ................................................................................................................ 14
2.10 Sustainability update .................................................................................................................................. 17
2.11 General corporate matters ......................................................................................................................... 18
3 Condensed financial statements .......................................................................................................................... 22
4 Notes ................................................................................................................................................................... 27
Financial calendar 2024 .......................................................................................................................................... 29
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 4
Corporate Release No 747/2023
1 FINANCIAL HIGHLIGHTS
For the nine months ended September 30
DKK million
9M 2023
9M 2022
Change
Change
(CER)
1
Revenue
14,934
13,566
10%
9%
Gross profit
11,657
10,794
8%
6%
Gross margin
78.1%
79.6%
Adjusted gross profit
2
13,343
11,944
12%
10%
Adjusted gross margin
89.3%
88.0%
Sales and distribution costs
5,297
4,740
12%
15%
S&D ratio
35.5%
34.9%
Administrative expenses
915
756
21%
22%
Administrative expenses ratio
6.1%
5.6%
Research and development costs
2,481
2,849
(13%)
(12%)
R&D ratio
16.6%
21.0%
EBIT (profit from operations)
2,964
2,449
21%
6%
EBIT margin
19.8%
18.1%
EBITDA
3
4,463
3,753
19%
9%
EBITDA margin
29.9%
27.7%
Adjusted EBITDA
4
4,859
3,705
31%
20%
Adjusted EBITDA margin
32.5%
27.3%
Net financials, expenses
146
392
(63%)
-
Profit before tax
2,818
2,057
37%
-
Income taxes
662
452
46%
-
Effective tax rate (reported)
23.5%
22.0%
Net profit
2,156
1,605
34%
-
Adjusted net profit
3,620
2,847
27%
-
Other key numbers
Assets
37,672
39,305
(4%)
-
Equity
22,305
20,919
7%
-
Cash flows from operating and investing activities
(free cash flow)
2,777
872
218%
-
Net cash flow for the period
713
1,041
(32%)
-
Return on invested capital – rolling four quarters
11.1%
8.9%
Net debt/EBITDA – rolling four quarters
0.0
0.7
-
-
Number of shares for the calculation of EPS (millions)
992.3
992.9
0%
-
Earnings per share, basic (EPS) (DKK)
2.17
1.62
34%
-
Adjusted earnings per share, basic (DKK)
3.65
2.87
27%
-
1
Constant Exchange Rates (CER) previously denominated Local Currency (LC). Change at CER does not include effects from hedging.
2
Adjusted gross profit is the gross profit excluding depreciation and amortization and other adjustments linked to sales.
3
EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization.
4
EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization. Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see
section 4 Notes, note 3 Adjusted EBITDA.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 5
Corporate Release No 747/2023
2 BUSINESS PERFORMANCE
2.1 REVENUE BY PRODUCT
Revenue reached DKK 14,934 million representing a
growth of 10% (+9% CER). The revenue growth is
driven by strong performance of strategic brands
reaching DKK 10,091 million, representing a growth
of 14% (+16% CER) and equivalent to 68% of total
revenue. The largest markets for the strategic brands
are the U.S., Canada, Spain, Italy and Australia.
DKK million
9M 2023
9M 2022
Change
Change
(CER)
Q3 2023
Q3 2022
Growth
Growth
(CER)
Rexulti
®
/Rxulti
®
3,309
2,817
17%
19%
1,174
1,046
12%
20%
Brintellix
®
/Trintellix
®
3,207
3,177
1%
4%
1,051
1,126
(7%)
0%
Abilify Maintena
®
/Asimtufii
2,374
2,164
10%
11%
790
771
2%
7%
Vyepti
®
1,201
672
79%
81%
444
282
57%
69%
Strategic brands
10,091
8,830
14%
16%
3,459
3,225
7%
14%
Cipralex
®
/Lexapro
®
1,701
1,874
(9%)
(5%)
501
620
(19%)
(10%)
Sabril
®
318
482
(34%)
(34%)
94
160
(41%)
(38%)
Other pharmaceuticals
2,587
2,576
0%
3%
787
864
(9%)
(1%)
Mature brands
4,606
4,932
(7%)
(3%)
1,382
1,644
(16%)
(8%)
Other revenue
193
205
(6%)
(7%)
61
49
24%
24%
Total revenue before hedging
14,890
13,967
7%
9%
4,902
4,918
0%
7%
Effects from hedging
44
(401)
50
(199)
Total revenue
14,934
13,566
10%
9%
4,952
4,719
5%
7%
Strategic brands
Rexulti
®
/Rxulti
®
(brexpiprazole) 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 Brazil.
Further, it is approved for the treatment of agitation
associated with dementia due to Alzheimer’s disease
(AADAD) in the U.S. since May 2023. In the early
weeks following the approval, the brand has seen an
increased usage in 65+ patients. In addition, AADAD
is approved in other countries including Canada. In
Australia and Europe, the product is approved only
for schizophrenia. Revenue reached DKK 3,309
million representing a growth of 17% (+19% CER) as
a result of strong demand and price increases. The
revenue distribution by region was 93%, 1% and 6%
in the U.S., Europe and International Markets,
respectively. The largest markets are the U.S., Brazil,
Canada, Australia and Mexico.
Brintellix
®
/Trintellix
®
(vortioxetine) is approved for
the treatment of major depressive disorder (MDD).
Revenue reached DKK 3,207 million representing a
growth of 1% (+4% CER) following continued growth
in Europe and International Markets, mainly in Spain,
Canada, Japan and Brazil. The development is
mainly driven by higher demand in Europe and a
combination of higher demand and growth in some
regions of International Markets, offset by lower
demand and higher gross-to-net in the U.S. as well
as lower sales in China. The revenue distribution by
region was 33%, 34% and 33% in the U.S., Europe
and International Markets, respectively. The largest
markets for the product are the U.S., Canada, Spain,
Italy and Brazil.
Abilify Maintena
®
(aripiprazole) is approved for the
treatment of schizophrenia in Europe and for both
schizophrenia and bipolar I disorder in the U.S.,
Canada and Australia as a once-monthly injection.
On April 27, 2023 FDA approved a New Drug
Application (NDA) for aripiprazole as an every-two-
months injection branded as Abilify Asimtufii
®
which
was launched in the U.S. in June 2023. Revenue for
Abilify Maintena
®
and Abilify Asimtufii
®
reached DKK
2,374 million representing a growth of 10% (+11%
CER) driven by strong demand and price increases.
All regions presented revenue growth in the first nine
months of 2023. The revenue distribution by region
was 37%, 45% and 18% in the U.S., Europe and
International Markets, respectively. The largest
markets are the U.S., Spain, Canada, Australia and
Italy.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 6
Corporate Release No 747/2023
Vyepti
®
(eptinezumab) is approved as preventive
treatment of migraine in adults. Vyepti
®
presented
continued significant performance in the first nine
months of 2023 and revenue reached DKK 1,201
million following a growth of 79% (+81% CER) driven
by demand uptake in the U.S., continued launches
across the world. Vyepti
®
was launched in April 2020
in the U.S. and has since been launched in around 20
markets in total. In October 2023, Vyepti
®
received
public formulary coverage from the provinces of
Ontario, Alberta, Quebec, New Brunswick, Nova
Scotia, Northwest Territories, and the Non-Insured
Health Benefits Program (NIHB). Combined, this
coverage allows more than 70% of eligible Canadian
patients living with migraine to have access to Vyepti
®
who rely on public drug plans for reimbursement of
their treatments. In the last quarter of 2023, Vyepti
®
is expected to be launched in a few additional
markets. The revenue distribution by region was
93%, 4% and 3% in the U.S., Europe and
International Markets, respectively.
Mature brands
Cipralex
®
/Lexapro
®
(escitalopram) is approved for
the treatment of MDD. Revenue reached DKK 1,701
million representing a decline of 9% (-5% CER)
mainly as a consequence of generic competition in
Japan since the end of 2022, partially offset by growth
in Europe driven mainly by price favorability and stock
build-up. The revenue distribution by region was 69%
and 31% in International Markets and Europe,
respectively. The largest markets are China, South
Korea, Brazil, Italy and Japan.
Sabril
®
(vigabatrin) is approved for the treatment of
refractory complex partial seizures (rCPS) and
infantile spasms (IS). Revenue reached DKK 318
million representing a decline of 34% (-34% CER)
mainly driven by generic erosion and supply outage
as a consequence of a third-party manufacturing
quality issue.
Revenue from Other pharmaceuticals, which
comprise the remainder of Lundbeck’s products, was
unchanged (+3% CER) at DKK 2,587 million,
benefiting from quarterly fluctuations partially offset
by lower sales of certain mature products such as
Northera
®
. As of January 1, 2023, Onfi
®
is being
reported together with Other pharmaceuticals,
comparative figures for 2022 have been adjusted
accordingly. The largest markets for Other
pharmaceuticals are the U.S, China, France, South
Korea and Mexico.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 7
Corporate Release No 747/2023
2.2 REVENUE BY GEOGRAPHICAL AREA
DKK million
9M
2023
9M
2022
Change
Change
(CER)
Q3
2023
Q3
2022
Growth
Growth
(CER)
United States
Rexulti
®
3,074
2,636
17%
18%
1,094
983
11%
19%
Vyepti
®
1,119
657
70%
73%
415
270
54%
64%
Trintellix
®
1,057
1,178
(10%)
(8%)
362
442
(18%)
(11%)
Abilify Maintena
®
/Asimtufii
866
766
13%
14%
286
279
3%
10%
Strategic brands
6,116
5,237
17%
19%
2,157
1,974
9%
17%
Mature brands
1,201
1,348
(11%)
(10%)
373
479
(22%)
(17%)
Revenue – United States
7,317
6,585
11%
13%
2,530
2,453
3%
11%
Europe
Brintellix
®
1,106
965
15%
16%
361
335
8%
12%
Abilify Maintena
®
1,072
1,001
7%
7%
357
344
4%
3%
Vyepti
®
49
5
880%
895%
22
5
340%
421%
Rexulti
®
/Rxulti
®
42
30
40%
38%
14
10
40%
48%
Strategic brands
2,269
2,001
13%
14%
754
694
9%
11%
Mature brands
1,185
1,153
3%
6%
367
393
(7%)
3%
Revenue – Europe
3,454
3,154
10%
11%
1,121
1,087
3%
8%
International Markets
Brintellix
®
1,044
1,034
1%
6%
328
349
(6%)
2%
Abilify Maintena
®
436
397
10%
17%
147
148
(1%)
10%
Rexulti
®
193
151
28%
32%
66
53
25%
30%
Vyepti
®
33
10
230%
234%
7
7
0%
21%
Strategic brands
1,706
1,592
7%
13%
548
557
(2%)
7%
Mature brands
2,220
2,431
(9%)
(4%)
642
772
(17%)
(8%)
Revenue – International
Markets
3,926
4,023
(2%)
3%
1,190
1,329
(10%)
(2%)
Other revenue
193
205
(6%)
(7%)
61
49
24%
24%
Total revenue before hedging
14,890
13,967
7%
9%
4,902
4,918
0%
7%
Effects from hedging
44
(401)
50
(199)
Total revenue
14,934
13,566
10%
9%
4,952
4,719
5%
7%
Lundbeck’s largest markets are the U.S., China,
Canada, Spain and Italy.
United States revenue reached DKK 7,317 million
representing a growth of 11% (+13% CER). The
strategic brands reached DKK 6,116 million
increasing by 17% (+19% CER), representing 84% of
the revenue. The revenue growth was driven by
strong demand for Vyepti
®
, Rexulti
®
and Abilify
Maintena
®
/Asimtufii. Sales of Trintellix
®
continues to
be negatively impacted by declining demand and
higher gross-to-net following a shift in the payer mix.
Revenue development in the U.S. is furthermore
impacted by the erosion of mature brands such as
Northera
®
and Sabril
®
as well as a supply outage of
Sabril
®
as a consequence of a third-party
manufacturing quality issue.
Europe revenue reached DKK 3,454 million
representing a growth of 10% (+11% CER). The
strategic brands reached DKK 2,269 million
increasing by 13% (+14% CER), representing 66% of
revenue. The revenue growth is driven by strong
performance across all strategic brands. Europe
contributed positively to the performance of mature
brands reaching DKK 1,185 million representing a
growth of 3% (+6% CER), offset by a negative
currency impact in Turkey. The largest markets in
Europe are Spain, Italy, France and Switzerland.
International Markets comprise all Lundbeck’s
markets outside the U.S. and Europe. Revenue
reached DKK 3,926 million representing a decline of
2% (+3% CER). The strategic brands reached DKK
1,706 million increasing by 7% (+13% CER),
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 8
Corporate Release No 747/2023
representing 43% of revenue. The development is
mainly driven by the erosion of Lexapro
®
in Japan
following the entry of generic competition since the
end of 2022 as well as a negative currency impact in
China and Canada, partially offset by higher sales in
China. The biggest markets are China, Canada,
Brazil, Australia and South Korea. China and Canada
constitute approximately 43% of regional revenue.
Lundbeck hedges a significant part of the currency
risk for a period of 12 – 18 months. Hedging had a
positive impact of DKK 44 million in the first nine
months of 2023, compared to a negative impact of
DKK 401 million in the same period last year.
2.3 GROSS PROFIT
DKK million
9M
2023
9M
2022
Change
Change
(CER)
Q3
2023
Q3
2022
Change
Change
(CER)
Revenue
14,934
13,566
10%
9%
4,952
4,719
5%
7%
Cost of sales
3,277
2,772
18%
21%
1,098
961
14%
20%
thereof adjustments
327
-
-
-
67
-
-
-
thereof amortization of product rights
1,173
971
21%
21%
384
347
11%
14%
thereof depreciation/amortization
186
179
4%
4%
63
62
2%
2%
Gross profit
11,657
10,794
8%
6%
3,854
3,758
3%
4%
Gross margin (%)
78.1%
79.6%
77.8%
79.6%
Adjusted gross profit
13,343
11,944
12%
10%
4,368
4,167
5%
6%
Adjusted gross margin (%)
89.3%
88.0%
88.2%
88.3%
Cost of sales reached DKK 3,277 million increasing
by 18% (+21% CER), mainly driven by higher sales,
Vyepti
®
provision for inventory obsolescence of DKK
312 million and increased Vyepti
®
amortization
recognized in the first nine months of 2023 related to
the European approval of Vyepti
®
.
Gross profit reached DKK 11,657 million, increasing
by 8% (+6% CER) in the first nine months of 2023.
The gross margin was 78.1% representing a decline
of 1.5 percentage points.
Adjusted gross profit is the gross profit excluding
depreciation and amortization and other adjustments
linked to sales. The adjusted gross margin was
89.3% representing an increase of 1.3 percentage
points and in line with revenue performance.
Amortization of product rights was DKK 1,173 million,
increasing by 21% (+21% CER) driven mainly by
increase in Vyepti
®
amortization.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 9
Corporate Release No 747/2023
2.4 EBIT AND ADJUSTED EBITDA
DKK million
9M
2023
9M
2022
Change
Change
(CER)
Q3
2023
Q3
2022
Change
Change
(CER)
Revenue
14,934
13,566
10%
9%
4,952
4,719
5%
7%
Gross profit
11,657
10,794
8%
6%
3,854
3,758
3%
4%
thereof adjustments
327
-
-
-
67
-
-
-
thereof depreciation/amortization
1,359
1,150
18%
19%
447
409
9%
12%
Sales and distribution costs
5,297
4,740
12%
15%
1,796
1,653
9%
16%
thereof adjustments
-
(43)
-
-
-
-
-
-
thereof depreciation/amortization
70
77
(9%)
(6%)
23
30
(23%)
(20%)
S&D-ratio
35.5%
34.9%
36.3%
35.0%
Administrative expenses
915
756
21%
22%
351
247
42%
45%
thereof adjustments
69
-
-
-
69
-
-
-
thereof depreciation/amortization
16
13
23%
15%
6
5
20%
0%
Administrative expenses ratio
6.1%
5.6%
7.1%
5.2%
Research and development costs
2,481
2,849
(13%)
(12%)
816
906
(10%)
(8%)
thereof adjustments
-
(5)
-
-
-
-
-
-
thereof depreciation/amortization
54
64
(16%)
(14%)
18
18
0%
0%
R&D-ratio
16.6%
21.0%
16.5%
19.2%
Total operating expenses
8,693
8,345
4%
6%
2,963
2,806
6%
11%
OPEX-ratio
58.2%
61.5%
59.8%
59.5%
EBIT (profit from operations)
2,964
2,449
21%
6%
891
952
(6%)
(14%)
Depreciation/amortization
1,499
1,304
15%
15%
494
462
7%
10%
EBITDA
4,463
3,753
19%
9%
1,385
1,414
(2%)
(7%)
EBITDA margin (%)
29.9%
27.7%
28.0%
30.0%
Restructuring expenses
15
(48)
(131%)
(131%)
-
-
-
-
Other adjustments
381
-
-
-
136
-
-
-
Adjusted EBITDA
4,859
3,705
31%
20%
1,521
1,414
8%
1%
Adjusted EBITDA margin (%)
32.5%
27.3%
30.7%
30.0%
Total operating expenses (OPEX) reached DKK
8,693 million corresponding to an increase of 4%
(+6% CER) mainly driven by higher sales and
distribution costs as well as administrative expenses
offset by lower R&D costs. The OPEX-ratio declined
by 3.3 percentage points.
Sales and distribution costs reached DKK 5,297
million corresponding to an increase of 12% (+15%
CER) mainly driven by higher Rexulti
®
and Vyepti
®
sales activity in the U.S. and global roll-out of Vyepti
®
.
Sales and distribution costs corresponded to 35.5%
of revenue, representing an increase of 0.6
percentage points.
Administrative expenses reached DKK 915 million
increasing by 21% (+22% CER) corresponding to
6.1% of total revenue mainly driven by higher legal
provisions for ongoing litigations, expenses from
digital investments and the CEO transition.
Research and development costs reached DKK
2,481 million with an R&D ratio of 16.6%. Lower R&D
costs of 13% (-12% CER) reflect reduced late
development and phase IV activities for the first nine
months of 2023. Last year, the phase IV trials on
Brintellix
®
/Trintellix
®
were completed and the pivotal
trial on Rexulti
®
was finalized. Further decreases in
the first nine months of 2023 can be attributed to
lower costs for Lu AG09222 (aPACAP) phase IIa
HOPE trial and Lu AF82422 phase II AMULET trial.
EBIT reached DKK 2,964 million increasing by 21%
(+6% CER) reflecting the operating leveraging effect
of higher revenue, combined with a lower OPEX-
ratio.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 10
Corporate Release No 747/2023
Amortization of product rights amounted to DKK
1,173 million corresponding to an increase of 21%
(+21% CER). Total amortization, depreciation and
impairment losses reached DKK 1,499 million
representing an increase of 15% (+15% CER) mainly
driven by increase of Vyepti
®
amortization.
Adjusted EBITDA reached DKK 4,859 million
representing a growth of 31% (+20% CER) reflecting
EBIT and EBITDA development in addition to
adjustments of DKK 312 million of Vyepti
®
inventory
obsolescence, DKK 69 million regarding higher legal
provisions for ongoing litigations and DKK 15 million
of restructuring costs for the closure of the sterile
manufacturing line in France.
2.5 NET PROFIT AND ADJUSTED EPS
DKK million
9M 2023
9M 2022
Change
Q3 2023
Q3 2022
Change
EBIT (profit from operations)
2,964
2,449
21%
891
952
(6%)
Net financials, (income)/expenses
146
392
(63%)
8
70
(89%)
Profit before tax
2,818
2,057
37%
883
882
0%
Net profit
2,156
1,605
34%
676
688
(2%)
thereof other adjustments
396
(48)
(925%)
136
-
-
thereof depreciation/amortization
1,499
1,304
15%
494
462
7%
thereof adjustments on financial items
-
278
-
-
-
-
thereof tax on adjustments
431
292
48%
143
107
34%
EPS (DKK)
2.17
1.62
34%
0.68
0.69
(1%)
Adjusted net profit
3,620
2,847
27%
1,163
1,043
12%
Adjusted EPS (DKK)
3.65
2.87
27%
1.17
1.05
11%
Net profit
Net financial expenses reached DKK 146 million
equivalent to a decline of 63%. The first nine months
of 2022 was impacted by the European approval of
Vyepti
®
which triggered a fair value adjustment of
contingent consideration of CVR to former Alder
shareholders amounting to DKK 278 million. In
addition, the lower debt levels have positively
impacted the performance being partially offset by
currency impact.
The effective tax rate for the first nine months of
2023 was 23.5% (22.0% for the first nine months of
2022). The tax rate is in line with the full-year
expectation, reflecting the reduced deduction benefit
from the Danish research & development incentive of
108% (130% in 2022).
Net profit reached DKK 2,156 million corresponding
to a growth of 34%.
Adjusted net profit and EPS
Adjusted net profit is the net profit excluding
depreciation and amortization and other adjustments,
net of taxes. Adjusted net profit reached DKK 3,620
million, representing an increase of 27%. The
adjustments mainly related to amortization of product
rights, higher legal provisions for ongoing litigations
and Vyepti
®
provision for obsolescence.
Adjusted EPS was DKK 3.65 corresponding to an
increase of 27%.
2.6 CASH FLOW AND BALANCE SHEET
Cash flows from operating activities amounted to
an inflow of DKK 3,139 million compared to an inflow
of DKK 2,232 million in the first nine months of 2022.
The positive development is primarily driven by
higher revenue and EBITDA, which was partly offset
by higher working capital mainly driven by a decrease
in short-term liabilities due to Rexulti
®
milestone
payment in the first nine months of 2023. Inventory
development in the first nine months of 2023 was
lower compared to the first nine months of 2022
driven by the fixed batch quantity supply entirely
delivered by September 2023.
Lundbeck’s net cash flows from investing
activities were an outflow of DKK 362 million mainly
due to milestone payments in the first nine months of
2023 and to an outflow of DKK 1,360 million in the
first nine months of 2022 related to the CVR payment
triggered by the European approval of Vyepti
®
.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 11
Corporate Release No 747/2023
Lundbeck’s net cash flows from financing
activities were an outflow of DKK 2,064 million
compared to an inflow of DKK 169 million in the first
nine months of 2022. The financing cash flows in the
first nine months of 2023 mainly relate to dividend
payment approved at the Annual General Meeting in
March 2023 as well as repayment of debt. The first
nine months of 2022 were impacted by a drawdown
on a loan to pay the CVR following the European
approval of Vyepti
®
.
The net cash inflow reached DKK 713 million
compared to an inflow of DKK 1,041 million in the first
nine months of 2022.
Net debt has decreased from DKK 3,021 million at
the end of September 2022 to DKK 46 million at the
end of September 2023. Net debt/EBITDA ratio is
0.0x at the end of September 2023 compared to 0.7x
at the end of September 2022. Interest-bearing debt
was DKK 4,294 million at the end of September 2023
compared to DKK 6,427 million at the end of
September 2022.
On September 30, 2023, Lundbeck’s total assets
amounted to DKK 37,672 million compared to DKK
37,452 million at the end of 2022.
On September 30, 2023, Lundbeck’s equity
amounted to DKK 22,305 million.
2.7 SUMMARY OF THE KEY DEVELOPMENTS IN THE THIRD QUARTER OF 2023
For the quarter ended September 30
DKK million
Q3 2023
Q3 2022
Change
Change
(CER)
1
Revenue
4,952
4,719
5%
7%
Gross profit
3,854
3,758
3%
4%
Gross margin
77.8%
79.6%
Adjusted gross profit
2
4,368
4,167
5%
10%
Adjusted gross margin
88.2%
88.3%
Sales and distribution costs
1,796
1,653
9%
16%
S&D ratio
36.3%
35.0%
Administrative expenses
351
247
42%
45%
Administrative expenses ratio
7.1%
5.2%
Research and development costs
816
906
(10%)
(8%)
R&D ratio
16.5%
19.2%
EBIT (profit from operations)
891
952
(6%)
(14%)
EBIT margin
18.0%
20.2%
EBITDA
3
1,385
1,414
(2%)
(7%)
EBITDA margin
28.0%
30.0%
Adjusted EBITDA
4
1,521
1,414
8%
1%
Adjusted EBITDA margin
30.7%
30.0%
Net financials, expenses
8
70
(89%)
Profit before tax
883
882
0%
Income taxes
207
194
7%
Effective tax rate (reported)
23.5%
22.0%
Net profit
676
688
(2%)
Adjusted net profit
1,163
1,043
12%
1
Change at CER does not include effects from hedging.
2
Adjusted gross profit is the gross profit excluding depreciation and amortization and other adjustments linked to sales.
3
EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization.
4
EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization. Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see section
4 Notes, note 3 Adjusted EBITDA.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 12
Corporate Release No 747/2023
REVENUE
The increase in revenue is mainly driven by strong
performance across the strategic brands reaching
DKK 3,459 million, representing a growth of 7%
(+14% CER), equivalent to 70% of total revenue (see
section 2.1) in the third quarter of 2023. This
development was mainly driven by a combination of
revenue growth for Vyepti
®
, Rexulti
®
/ Rxulti
®
and
Abilify Maintena
®
/Asimtufii, offset by a decline in
Brintellix
®
/Trintellix
®
revenue due to reduced sales in
U.S. and China as well as a negative currency impact
in China and Canada.
Mature brands revenue decline was mainly driven by
Sabril
®
and Cipralex
®
/Lexapro
®
, respectively, in the
U.S. and International Markets, negatively impacted
by currency in China.
GROSS PROFIT
In the third quarter of 2023, gross profit reached
DKK 3,854 million increasing by 3% (+4% CER).
The gross margin was 77.8% representing a decline
of 1.8 percentage points. Adjusted gross margin
was 88.2% in the third quarter of 2023 representing a
decrease of 0.1 percentage point.
Cost of sales increased to DKK 1,098 million, driven
by higher revenue, impact from increased Vyepti
®
amortization and provision for Vyepti
®
obsolescence
of DKK 67 million recognized in the third quarter of
2023.
EBIT AND ADJUSTED EBITDA
Total operating expenses (OPEX) reached DKK
2,963 million corresponding to an increase of 6%
(+11% CER) mainly driven by higher sales and
increase in distribution costs and administrative
expenses, offset by lower R&D costs. The OPEX-
ratio increased by 0.3 percentage points.
Sales and distribution costs reached DKK 1,796
million corresponding to an increase of 9% (+16%
CER) mainly driven by higher sales activity level for
Vyepti
®
and Rexulti
®
mainly in the U.S.
Administrative expenses reached DKK 351 million
increasing by 42% (+45% CER) corresponding to
7.1% of total revenue mainly driven by higher legal
provisions for ongoing litigations.
Research and development costs reached DKK
816 million with a R&D ratio of 16.5%. The decrease
in R&D costs of 10% (-8% CER) are due to lower
project costs in the third quarter of 2023.
EBIT reached DKK 891 million declining by 6% (-14%
CER) reflecting higher revenue combined with a
slightly increased OPEX-ratio driven by a negative
impact of Vyepti
®
provision for obsolescence,
increase in Vyepti
®
amortization and higher legal
provisions for ongoing litigations.
Amortization of product rights amounted to DKK
384 million corresponding to an increase of 11%
(+14% CER). Total amortization, depreciation and
impairment losses reached DKK 494 million
representing an increase of 7% (+10% CER) mainly
driven by increase in Vyepti
®
amortization.
Adjusted EBITDA reached DKK 1,521 million
representing a growth of 8% (1% CER) reflecting
EBIT and EBITDA development in addition to the
adjustments of DKK 67 million of Vyepti
®
inventory
obsolescence and DKK 69 million regarding higher
legal costs provisions for ongoing litigations.
NET PROFIT AND ADJUSTED EPS
Net financial (income)/expenses reached DKK 8
million equivalent to a decline of 89%.
The effective tax rate for the third quarter of 2023
was 23.5%.
Net profit reached DKK 676 million corresponding to
a decline of 2%.
Adjusted net profit reached DKK 1,163 million,
representing an increase of 12%.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 13
Corporate Release No 747/2023
2.8 OUTLOOK
Financial guidance 2023
Based on robust business performance year to date
and Lundbeck’s expectations for the remaining year,
Lundbeck has narrowed the financial guidance range
for the full-year. The financial guidance range for
Adjusted EBITDA has also been raised largely due to
lower than planned R&D costs.
Lundbeck expects revenue to reach DKK 19.8 to 20.1
billion compared to previously DKK 19.5 to 20.1
billion. The growth is driven by robust demand of the
strategic brands which more than offsets the
continued erosion of the mature portfolio and despite
depreciation of the main currencies when compared
to 2022. The revised financial guidance for 2023 is
provided based on the exchange rates at the end of
October 2023.
Lundbeck continues the global roll-out of Vyepti
®
.
Rexulti
®
was launched with the additional AADAD
indication in June 2023 together with Abilify
Asimtufii
®
, both in the U.S. Brintellix
®
/Trintellix
®
is
impacted by low growth in the U.S. and China as well
as increased generic pressure in Brazil.
The mature brands are expected to face stronger
generic erosion, especially on Cipralex
®
/Lexapro
®
in
Japan, Deanxit
®
in China and Sabril
®
in the U.S. The
rest of 2023 is also expected to be dampened when
compared to the first half of 2023 by timing of
shipments in the first half of the year to countries such
as Saudi Arabia and Taiwan. Additionally, currency
devaluation in Egypt will constrain Letter of Credit
insured shipments, and in Turkey, local inflation
levels are expected to reduce local demand.
Lundbeck’s expectations for Adjusted EBITDA has
been narrowed and raised. Lundbeck now expects
Adjusted EBITDA to reach DKK 5.6 to 5.8 billion
compared to previously DKK 5.2 to 5.6 billion. The
change to Adjusted EBITDA is largely driven by lower
than planned R&D costs. The financial guidance for
2023 reflects the investments needed in the important
launches driving significant future growth. Adjusted
EBITDA will be impacted by the required investments
in the U.S. to launch Rexulti
®
in AADAD and Abilify
Asimtufii
®
as well as the continued roll-out of Vyepti
globally in line with previously communicated.
R&D costs are now expected to be lower than
planned due to i) transition from early-stage to mid-
stage development for projects such as Lu AG09222
(aPACAP mAb), Lu AF82422 (anti-α-synuclein mAb)
and Lu AG22151 (aCD40L blocker) moved into 2024,
ii) costs related to Vyepti clinical trials such as
SUNLIGHT China MoH, DELIVER and ALLEVIATE
Cluster Headache, and iii) costs tied to studies with
Otsuka for AADAD and PTSD.
Lundbeck mainly carries foreign currency risk in USD,
CNY and CAD. The financial guidance for 2023 is
based on expected hedging rates for the main
currencies, i.e. USD/DKK (~7.36), CNY/DKK (~1.00)
and CAD/DKK (~5.12) and includes an expected
hedging gain of approximately DKK 66 million.
Based on assumptions for product and geographical
mix, it is estimated that a 5% change of the USD/DKK
exchange rate will impact revenue by approximately
DKK 50 million for the remaining period of 2023.
FY 2022 actual
Previous
FY 2023 guidance
Revised
FY 2023 guidance
Revenue
DKK 18.2 billion
DKK 19.5 – 20.1 billion
DKK 19.8 – 20.1 billion
Adjusted EBITDA
DKK 4.8 billion
DKK 5.2 – 5.6 billion
DKK 5.6 – 5.8 billion
Mid-term targets are confirmed
Lundbeck is in a period with limited impact from major
regional losses of exclusivity and anticipates solid
growth of its strategic brands.
In 2023 and 2024, we plan targeted investments
behind the potential blockbuster opportunity for
Rexulti
®
in the treatment of AADAD. Based on
organic growth, we expect revenue to show a mid-
single digit compound annual growth rate (CAGR)
over the mid-term (3-4 years).
At the same time, we remain focused on driving
efficiencies and being prudent in our spending. Based
on these assumptions, we target an adjusted
EBITDA-margin of 30-32% for the current business,
excluding any business development activities, by
the end of the mid-term period.
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
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 14
Corporate Release No 747/2023
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.
2.9 LUNDBECK’S DEVELOPMENT PORTFOLIO
Lundbeck is developing several new and promising
medicines for the treatment of brain diseases.
The 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
Adrenocorticotropic hormone.
6
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 alpha1B/2C receptors.
7
Monoacylglycerol lipase inhibitor (“MAGlipase”) program.
8
Approved in the U.S.
Hormonal / neuropeptide signaling
Eptinezumab – development and regulatory
status
In December 2020, Lundbeck initiated a phase III
clinical trial investigating the efficacy of eptinezumab
in patients with episodic cluster headache
(ALLEVIATE). In this trial (NCT04688775), patients
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 one-year safety and
tolerability trial in participants with chronic cluster
headache (CHRONICLE). The CHRONICLE trial
(NCT05064397) has completed recruitment and
results show that patients with chronic cluster
headache receiving open-label treatment with
eptinezumab report reductions in attack frequency,
pain severity, and improvement on patient global
impression. In the ALLEVIATE trial, further
recruitment was halted following a planned interim
analysis. Full data for eptinezumab in cluster
headache will be shared with the scientific community
at upcoming meetings.
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 November 2021, Lundbeck initiated the HOPE-
trial, 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
recently reported results. The target population for
this trial was defined as patients diagnosed with
migraine as outlined in the International Classification
of Headache Disorders Third Edition (ICHD-3) and
with unsuccessful prior preventive treatments. A total
of 237 patients were randomly allocated to one of
three treatment groups: high/low dose of Lu AG09222
or placebo. The primary analysis concluded that there
was a statistically significant difference (p=0.01)
between Lu AG09222 and placebo in the mean
change from baseline in the number of monthly
Project
Area
Phase I
Phase II
Phase III
Filing/
Launch
Hormonal / neuropeptide signaling:
Eptinezumab (anti-CGRP)
1
Migraine prevention
SUN-studies
2
Cluster headache
CHRONICLE
3
ALLEVIATE
Lu AG09222 (anti-PACAP mAb)
4
Migraine prevention
Lu AG13909 (anti-ACTH mAb)
5
Neuro-hormonal dysfunctions
Circuitry / neuronal biology:
Brexpiprazole
6
Agitation in Alzheimer’s disease
8
PTSD
Aripiprazole 2-months injectable
Schizophrenia/bipolar I disorder
8
MAGLi program
7
Neurology/psychiatry
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
Neuroinflammation / neuroimmunology:
Lu AG22151 (anti-CD40L blocker)
Neurology
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 15
Corporate Release No 747/2023
migraine days over weeks 1 to 4. Lu AG09222 was
generally well tolerated.
A phase IIb trial is planned to start up in the first half
of 2024 with the purpose to establish dose range
relationship when Lu AG09222 is given after
subcutaneous multiple dosing. The trial will be
conducted across the world with a target population
of patients diagnosed with migraine as outlined in the
International Classification of Headache Disorders
Third Edition (ICHD-3) and with unsuccessful prior
preventive treatment.
Lu AG22515 – phase I
Lu AG22515 is a novel first in class mAb with
potential to offer a safe and efficacious treatment
alternative to patients suffering from conditions with
elevated ACTH levels e.g. Congenital Adrenal
Hyperplasia (CAH) and Cushing's disease (CD).
A phase I study testing safety and efficacy of multiple
ascending doses of Lu AG22515 in CAH patients
(NCT05669950) was initiated December 2022.
Circuitry / neuronal biology
Brexpiprazole – phase III in patients with agitation
associated with dementia due to Alzheimer’s
Disease
A supplemental New Drug Submission (sNDS) was
formally accepted by Health Canada for review as of
April 12, 2023, with anticipated action in 2024, while
a joint application using the Access pathway was
submitted on May 31, 2023 for Australia, Singapore
and Switzerland with anticipated action in the second
quarter of 2024.
The submissions were based on two positive phase
III, 12-week, randomized, double-blind, placebo-
controlled fixed-dose studies that evaluated the
frequency of agitation symptoms in patients with
dementia due to Alzheimer’s disease based on the
Cohen-Mansfield Agitation Inventory (CMAI) total
score.
Brexpiprazole – phase III in adolescent patients
(13-17 years old) with schizophrenia
The phase III trial 331-10-234 in adolescent patients
with schizophrenia (NCT03198078) read out during
the second quarter of 2023, with the trial meeting its
primary endpoint, as measured by the PANSS total
score change from baseline to week 6 and
demonstrated a significant improvement for
brexpiprazole compared to placebo (p<0.05).
The active reference for the study, aripiprazole, also
separated from placebo on the primary efficacy
analysis, thus validating the study methodology and
patient population.
Brexpiprazole was generally well tolerated in the trial,
and the safety profile was similar to that observed in
adult patients with schizophrenia.
The trial forms part of the brexpiprazole EMA
Paediatric Investigation Plan (PIP), as well as an FDA
Post Marketing Requirement (PMR) following the
U.S. approval of brexpiprazole for treatment of
schizophrenia in adolescent patients. The U.S.
indication was obtained in December 2021 based on
pediatric PK comparability data and extrapolation of
adult efficacy data. For Europe, results of the study
will be submitted to EMA later in 2023.
The EMA PIP includes two further studies that are
currently ongoing:
1) A phase III open-label 2-year extension
study 331-10-236 (NCT03238326) enrolling
patients completing Trial 234
2) An extrapolation study 3331-201-00185
assessing the long-term efficacy in
adolescent subjects with schizophrenia, by
extrapolating data from completed
brexpiprazole trials in both adolescents and
adult subjects with schizophrenia.
Brexpiprazole – phase III in Post-Traumatic
Stress Disorder (PTSD)
On September 7, 2023, Lundbeck announced topline
results from two phase III trials of brexpiprazole as
combination therapy with sertraline for the treatment
of Post-Traumatic Stress Disorder in adults, namely
the flexible dose trial 071 (NCT04124614) and the
fixed dose trial 072 (NCT04174170). The flexible
dose trial met its primary endpoint, while the fixed
dose phase III trial missed its primary endpoint.
Lundbeck and Otsuka will discuss these results with
FDA to determine next steps.
Aripiprazole – 2-month Injectable (LAI)
formulation
The new 2-month formulation is an innovative
addition to the long-acting injectable (LAI) franchise
and has patent protection until the early part of the
next decade.
Lundbeck and Otsuka submitted the Marketing
Authorization Application (MAA) for aripiprazole as
an every-two months ready-to-use (RTU) long-acting
injectable for the maintenance treatment of
schizophrenia in adult patients stabilized with
aripiprazole to the European Medicines Agency
(EMA) on May 26, 2022. Due to a Committee for
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 16
Corporate Release No 747/2023
Medicinal Products for Human Use (CHMP)
procedural objection, Lundbeck withdrew its MAA
under the “hybrid” procedure and re-submitted to
EMA in June 2023, under the “line-extension”
procedure instead. This change is procedural only,
and unrelated to product quality or safety.
A supplemental New Drug Submission (sNDS) was
filed with Health Canada for the treatment of
schizophrenia and bipolar I disorder in the third
quarter of 2022. Following a CMC related Notice of
Deficiency (NOD) from Health Canada received in
July 2023, a response is under development, which
once submitted will start a new review cycle.
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 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 trial (AMULET) was initiated in
November 2021 (NCT05104476) and is presently
fully accrued with ongoing follow-up 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.
Headline result is expected during first half of 2024.
Orphan drug designation for MSA was granted by
EMA in April 2021 and SAKIGAKE pioneering drug
designation was granted by the Japanese Health
Authorities in March 2023.
Neuroinflammation / neuroimmunology
Lu AG22515 – phase I
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
potential in the treatment 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. Results showed
Lu AG22515 to be safe and well tolerated at all dose
levels tested. Furthermore, free soluble serum
CD40L showed a sharp, robust, and sustained dose-
dependent decrease, indicating target engagement.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 17
Corporate Release No 747/2023
2.10 SUSTAINABILITY UPDATE
Through Lundbeck’s sustainability strategy we
reduce negative impacts, address business risks and
opportunities, and contribute to addressing societal
challenges where possible.
In this sustainability update, progress is presented for
Environmental, Social and Governance matters
supported by key performance metrics.
ENVIRONMENTAL PERFORMANCE
Category
9M 2023
9M 2022
Change (%)
Scope 1 GHG emissions (Tonne CO₂ₑ)
1, 2
16,987
17,205
(1%)
Scope 2 GHG emissions (Market Based) (Tonne CO₂ₑ)
1, 3
3,088
3,086
0%
1
Comparative figures were updated to reflect changes in estimates.
2
Scope 1: Direct emissions from company owned and controlled resources (including emissions from production processes and transport). See Lundbeck Sustainability
Report 2022 for accounting policies and definitions
3
Scope 2: Indirect emissions from the generation of purchased energy. See Lundbeck Sustainability Report 2022 for accounting policies and definitions.
Climate Action
Saving energy and reducing CO₂ emissions are long-
standing strategic priorities for Lundbeck, both in own
operations and throughout the supply and distribution
chain.
In the first nine months of 2023, Scope 1 GHG
emissions decreased by 1% compared to the first
nine months of 2022 mainly driven by an increase in
use of renewable energy sources on sites. Even
though Scope 2 GHG emissions are at the same
level compared to the first nine months of 2022, it is
consistent with Lundbeck’s Low Carbon Transition
Plan for the period. Based on the developments in the
first nine months of 2023, Lundbeck remains on track
to meet the climate targets. Performance metrics
for scope 3 GHG emissions are updated twice per
year, in the half-year release and in the annual
sustainability report.
Circularity
Lundbeck continuously optimizes its manufacturing
processes based on circular economy principles to
limit materials use, waste, and carbon emissions. In
August 2023, a DKK 38 million investment in a
solvent recovery unit was approved. The facility will
be operational in 2025 and will allow Lundbeck to
increase the recycling of chemicals used in the active
pharmaceutical ingredients (API) production to meet
the global milestone in the low carbon transition plan
of 85% chemical recovery in 2030.
Performance metrics for circularity are updated
twice per year, in the half-year release and in the
annual sustainability report.
SOCIAL PERFORMANCE
Category
9M 2023
9M 2022
Change
2
Gender balance (women % in senior management)
1
36.4%
33.8%
2.6
1
Includes all Executive Vice Presidents, Senior Vice Presidents and Vice Presidents. Gender is assigned as female or male. Gender balance reported as female/male shares
of total. See Lundbeck Sustainability Report 2022 for accounting policies and definitions.
2
Variation in percentage points
Diversity, Equity and Inclusion
Everywhere Lundbeck operates, we strive to make a
positive contribution to the people and communities
we touch. This means safeguarding and developing
Lundbeck’s employees, taking action on gender
equality, neurodiversity and unconscious bias.
In the first nine months of 2023, the Gender balance
in senior management increased to 36.4% women,
which is up from 33.8% in the first nine months of
2022, equivalent to an increase of 2.6 percentage
points.
Access to Brain Health
Lundbeck has a responsibility to support disease
awareness and help address the societal burden.
During Migraine Awareness Week in September
2023, Lundbeck ran an awareness campaign to
elevate the understanding and education on
migraine. This is the latest example of Lundbeck's
position as a strong partner in brain health and
showcases Lundbeck's commitment to raise
awareness about migraine and helping people
suffering from it.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 18
Corporate Release No 747/2023
GOVERNANCE PERFORMANCE
Category
9M 2023
9M 2022
Change (%)
Due Diligence screenings of Suppliers and Third Parties (Number)
1
150
94
60%
1
Comparative figure was updated to reflect changes in estimates.
2
See Lundbeck Sustainability Report 2022 for accounting policies and definitions.
Responsible Business Conduct
Responsible business conduct is crucial to Lundbeck
as a pharmaceutical company. It is how Lundbeck
safeguard patient safety, uphold stakeholder
integrity, and minimize the risk of financial
repercussions.
Lundbeck’s Code of Conduct is the backbone of
Lundbeck’s ethics and compliance culture. The
annual Code of Conduct E-learning will be launched
in Q4 2023, and it is one of the important targets to
have all employees at work complete the training.
Lundbeck reports the completion rate in its annual
report.
Another important element of Lundbeck’s compliance
program is supplier and third-party management.
Lundbeck have systematic due diligence and
monitoring procedures for business collaborations,
aimed at identifying and mitigating specific risks. In
the first nine months of 2023 the Group have
conducted Due Diligence screenings of 150
Suppliers and Third Parties. This is a 60% increase
compared to the first nine months of 2022. This
increase is a testament to continuously growing
awareness across the organization on the
importance of ethical business conduct in the value
chain.
2.11 GENERAL CORPORATE MATTERS
Pending legal proceedings
Lundbeck is involved in a number of cases and legal
proceedings, including patent disputes, the most
significant of which are described below. Some of
these involve significant amounts and are subject to
considerable uncertainty. Management continuously
assesses the risks associated with the cases and
legal proceedings, and their likely outcome. It is the
opinion of the management that, apart from items
recognized in the financial statements, the outcome
of these cases and disputes are not probable or
cannot be reliably estimated in terms of amount or
timing. Such proceedings may, however, develop
over time, and new proceedings may occur, in a way
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 violation of competition law,
often arise when decisions and fines issued by the
European Commission are upheld by the European
Court of Justice. The below mentioned “follow-on
claims” are ongoing or threatened. Lundbeck
disagrees with all claims and intends to defend itself
against them.
At the end of first quarter 2023, the UK health
authorities served their claim form on Lundbeck and
several generic companies, and Lundbeck filed its
defense in the third quarter of 2023. In September
2023, a Case Management Conference was held, at
which the Competition Appeal Tribunal approved an
application for a preliminary issue hearing on whether
the claim is time-barred. The preliminary issue
hearing is expected to be held in the second quarter
of 2024 and a ruling on time-barring is expected later
in 2024.
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 filed its first
defense in May 2022 and the parties have
subsequently exchanged additional pleadings. The
first instance court hearing has been postponed to the
first quarter of 2024. It may take several years before
a final conclusion is reached by the German courts.
Lundbeck has been informed about potential claims
in other European countries, however, it is still
uncertain whether the potential claims will be actively
pursued.
In Canada, Lundbeck is involved in three product
liability class-action lawsuits relating to
Cipralex
®
/Celexa
®
(two cases alleging various
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 19
Corporate Release No 747/2023
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.
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.
Lundbeck’s case against the last of the four generic
companies, Sandoz Pty Ltd, went up to the High
Court of Australia, who has now decided that Sandoz
Pty Ltd infringed Lundbeck’s escitalopram patent
between 2009 and 2012. The High Court has now
sent the case back to the first instance court for
recalculation of the damages awarded to Lundbeck in
first instance which amounted to AUD 26.3 million. In
the meantime, Lundbeck’s appeal of the Australian
Patent Office’s decision to grant Sandoz a license is
restarted and if a license is maintained in any form,
the first instance court will have to decide if such a
license can have impact on the damage awarded by
the High Court.
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 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”) have been decided by the U.S. District
Court for the District of Delaware (the ‘Court’). The
Court found that Lundbeck’s compound patent (U.S.
Patent No. 7,144,884) is valid. The compound patent
expires 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
compound 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
Trintellix
®
. 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
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. The appeal hearing was held in September
2023 and a decision by the Court of Appeals is
expected late 2023 or early 2024.
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 (including the
promotional speaker program) 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 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. The trial has been scheduled
to start on April 1, 2024 and a District Court decision
is currently expected by August 2024. Abilify
Maintena
®
is covered by several U.S. 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
®
. The case was
dismissed with prejudice earlier in 2023.
In June 2023 in the U.S., Humana Inc., an insurer,
filed a complaint against Lundbeck U.S. legal entities.
The complaint alleges that Lundbeck engaged in an
illegal kickback scheme to increase the sales and
sale price of Lundbeck’s Xenazine
®
. The complaint
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 20
Corporate Release No 747/2023
alleges that Lundbeck’s activities targeted Humana
Inc. and other private Medicare insurers who were
forced to bear the costs of the alleged illegally
subsidized drug sales. 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, 2023 Page 21
Corporate Release No 747/2023
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 financial report
of H. Lundbeck A/S for the period January 1 to September 30, 2023. The financial report is presented in accordance
with IAS 34 Interim Financial Reporting, as adopted by the EU and additional Danish disclosure requirements for
interim financial reports of listed companies.
We consider the accounting policies applied to be appropriate. Accordingly, the financial report gives a true and fair
view of the Group’s assets, liabilities and financial position as of September 30, 2023, and of the results of the
Group’s operations and cash flows for the period, which ended on September 30, 2023.
In our opinion, the Management’s Review (pages 5-20) 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 2022.
The financial report has not been subject to audit or reviewed by the company’s independent auditors.
Valby, November 8, 2023
Registered Executive Management
Charl Gerhard Van Zyl
Lars Bang
Joerg Hornstein
Per Johan Luthman
President and CEO
Executive Vice President,
Product Development & Supply
Executive Vice President,
CFO
Executive Vice President,
Research & Development
Jacob Tolstrup
Executive Vice President,
Commercial Operations
Board of Directors
Lars Søren Rasmussen
Lene Skole-Sørensen
Santiago Arroyo
Jeffrey Berkowitz
Chair of the Board
Deputy Chair of the Board
Lars Erik Holmqvist
Jeremy Max Levin
Jakob Riis
Ilse Dorothea Wenzel
Hossein Armandi
Dorte Clausen
Lasse Skibsbye
Camilla Gram Andersson
Employee representative
Employee representative
Employee representative
Employee representative
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 22
Corporate Release No 747/2023
3 CONDENSED FINANCIAL STATEMENTS
CONDENSED STATEMENT OF PROFIT OR LOSS
DKK million
9M 2023
9M 2022
Q3 2023
Q3 2022
Revenue
14,934
13,566
4,952
4,719
Cost of sales
3,277
2,772
1,098
961
Gross profit
11,657
10,794
3,854
3,758
Sales and distribution costs
5,297
4,740
1,796
1,653
Administrative expenses
915
756
351
247
Research and development costs
2,481
2,849
816
906
Profit from operations (EBIT)
2,964
2,449
891
952
Net financials, expenses
146
392
8
70
Profit before tax
2,818
2,057
883
882
Tax on profit for the period
662
452
207
194
Profit for the period
2,156
1,605
676
688
Earnings per share, basic (EPS) (DKK)
2.17
1.62
0.68
0.69
Earnings per share, diluted (DEPS) (DKK)
2.17
1.62
0.68
0.69
STATEMENT OF COMPREHENSIVE INCOME
DKK million
9M 2023
9M 2022
Q3 2023
Q3 2022
Profit for the period
2,156
1,605
676
688
Actuarial gains/losses
-
-
-
-
Tax
-
-
-
-
Items that will not be reclassified subsequently to profit or
loss
-
-
-
-
Exchange rate gains/losses on investments in foreign subsidiaries
182
1,819
307
802
Exchange rate gains/losses on additions to net investments in
foreign subsidiaries
(86)
(69)
(46)
(21)
Hedging of net investments in foreign subsidiaries
17
(295)
-
(127)
Deferred gains/losses on cash flow hedge, exchange rate
(91)
(739)
(214)
(331)
Deferred gains/losses on cash flow hedge, interest rate
(21)
46
(5)
7
Deferred gains/losses on cash flow hedge, price
(58)
188
(17)
48
Exchange gains/losses, hedging (transferred to the hedged items)
(44)
401
(50)
199
Tax
63
106
74
51
Items that may be reclassified subsequently to profit or loss
(38)
1,457
49
628
Other comprehensive income
(38)
1,457
49
628
Comprehensive income
2,118
3,062
725
1,316
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 23
Corporate Release No 747/2023
CONDENSED STATEMENT OF FINANCIAL POSITION
DKK million
30.09.2023
31.12.2022
Assets
Intangible assets
21,599
22,500
Property, plant and equipment
2,470
2,515
Right-of-use assets
376
427
Other financial assets
119
173
Other receivables
228
195
Deferred tax assets
232
230
Non-current assets
25,024
26,040
Inventories
4,386
4,046
Receivables
4,014
3,818
Cash and bank balances
4,248
3,548
Current assets
12,648
11,412
Assets
37,672
37,452
Equity and liabilities
Share capital
996
996
Foreign currency translation reserve
1,566
1,438
Hedging reserve
(10)
156
Retained earnings
19,753
18,189
Equity
22,305
20,779
Retirement benefit obligations
207
213
Deferred tax liabilities
2,316
2,152
Provisions
307
190
Bank debt and bond debt
3,715
5,096
Lease liabilities
351
395
Other payables
433
428
Non-current liabilities
7,329
8,474
Retirement benefit obligations
1
1
Provisions
1,044
1,132
Trade payables
4,065
4,251
Lease liabilities
80
88
Income taxes payable
692
535
Other payables
2,156
2,192
Current liabilities
8,038
8,199
Liabilities
15,367
16,673
Equity and liabilities
37,672
37,452
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 24
Corporate Release No 747/2023
STATEMENT OF CHANGES IN EQUITY
DKK million
Share
capital
Foreign
currency
translation
reserve
Hedging
reserve
Retained
earnings
Total
equity
Equity at January 1, 2023
996
1,438
156
18,189
20,779
Profit for the period
-
-
-
2,156
2,156
Other comprehensive income
-
128
(166)
-
(38)
Comprehensive income
-
128
(166)
2,156
2,118
Distributed dividends, gross
-
-
-
(578)
(578)
Dividends received, treasury shares
-
-
-
2
2
Buyback of treasury shares
-
-
-
(43)
(43)
Incentive programs
-
-
-
26
26
Tax on other transactions in equity
-
-
-
1
1
Other transactions
-
-
-
(592)
(592)
Equity at September 30, 2023
996
1,566
(10)
19,753
22,305
DKK million
Share
capital
Foreign
currency
translation
reserve
Hedging
reserve
Retained
earnings
Total
equity
Equity at January 1, 2022
996
874
(162)
16,571
18,279
Profit for the period
-
-
-
1,605
1,605
Other comprehensive income
-
1,538
(81)
-
1,457
Comprehensive income
-
1,538
(81)
1,605
3,062
Distribution of dividends, gross
-
-
-
(398)
(398)
Dividends received, treasury shares
-
-
-
1
1
Buyback of treasury shares
-
-
-
(45)
(45)
Incentive programs
-
-
-
20
20
Tax on other transactions in equity
-
-
-
-
-
Other transactions
-
-
-
(422)
(422)
Equity at September 30, 2022
996
2,412
(243)
17,754
20,919
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 25
Corporate Release No 747/2023
CONDENSED STATEMENT OF CASH FLOWS
DKK million
9M 2023
9M 2022
Q3 2023
Q3 2022
Profit from operations (EBIT)
2,964
2,449
891
952
Adjustments for non-cash items
1,888
1,110
520
474
Change in working capital
(1,311)
(691)
170
125
Cash flows from operations before financial receipts and
payments
3,541
2,868
1,581
1,551
Financial receipts and payments
(93)
(484)
(8)
4
Cash flows from ordinary activities
3,448
2,384
1,573
1,555
Income taxes paid
(309)
(152)
(83)
(34)
Cash flows from operating activities
3,139
2,232
1,490
1,521
Contingent consideration, payment from acquisition of company
-
(1,076)
-
-
Purchase and sale of intangible assets and property, plant and
equipment
(362)
(284)
(97)
(133)
Cash flows from investing activities
(362)
(1,360)
(97)
(133)
Cash flows from operating and investing activities
(free cash flow)
2,777
872
1,393
1,388
Proceeds from loans and issue of bonds
-
1,234
-
-
Repayment of bank loans and borrowings
(1,377)
(552)
(789)
(286)
Dividends paid in the financial year, net
(576)
(397)
-
-
Other financing activities
(111)
(116)
(25)
(25)
Cash flows from financing activities
(2,064)
169
(814)
(311)
Net cash flow for the period
713
1,041
579
1,077
Cash and bank balances at beginning of period
3,548
2,279
3,663
2,298
Unrealized exchange gains/losses on cash and bank balances
(13)
86
6
31
Net cash flow for the period
713
1,041
579
1,077
Cash and bank balances at end of period
4,248
3,406
4,248
3,406
Interest-bearing debt, cash, bank balances and securities, net,
is composed as follows:
Cash and bank balances
4,248
3,406
4,248
3,406
Interest-bearing debt
(4,294)
(6,427)
(4,294)
(6,427)
Net cash/(net debt)
(46)
(3,021)
(46)
(3,021)
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 26
Corporate Release No 747/2023
STATEMENT OF PROFIT OR LOSS – ADJUSTED EBITDA RECONCILIATION (9M AND Q3)
9M 2023
9M 2022
DKK million
Reported
Adjusted
Reported
Adjusted
Revenue
14,934
14,934
13,566
13,566
Cost of sales
3,277
1,591
2,772
1,622
Gross profit
11,657
13,343
10,794
11,944
Sales and distribution costs
5,297
5,227
4,740
4,706
Administrative expenses
915
830
756
743
Research and development costs
2,481
2,427
2,849
2,790
Profit from operations (EBIT)
2,964
-
2,449
-
Depreciation/amortization
1,499
-
1,304
-
EBITDA
4,463
4,859
3,753
3,705
EBITDA margin
29.9%
32.5%
27.7%
27.3%
Adjustments to EBITDA
Integration costs
-
-
-
-
Restructuring expenses
15
-
(48)
-
Gains/losses on divestment of businesses
-
-
-
-
Acquisition expenses
-
-
-
-
Other adjustments
381
-
-
-
Adjusted EBITDA
4,859
4,859
3,705
3,705
Adjusted EBITDA margin
32.5%
32.5%
27.3%
27.3%
Q3 2023
Q3 2022
DKK million
Reported
Adjusted
Reported
Adjusted
Revenue
4,952
4,952
4,719
4,719
Cost of sales
1,098
584
961
552
Gross profit
3,854
4,368
3,758
4,167
Sales and distribution costs
1,796
1,773
1,653
1,623
Administrative expenses
351
276
247
242
Research and development costs
816
798
906
888
Profit from operations (EBIT)
891
-
952
-
Depreciation/amortization
494
-
462
-
EBITDA
1,385
1,521
1,414
1,414
EBITDA margin
28.0%
30.7%
30.0%
30.0%
Adjustments to EBITDA
Integration costs
-
-
-
-
Restructuring expenses
-
-
-
-
Gains/losses on divestment of businesses
-
-
-
-
Acquisition expenses
-
-
-
-
Other adjustments
136
-
-
-
Adjusted EBITDA
1,521
1,521
1,414
1,414
Adjusted EBITDA margin
30.7%
30.7%
30.0%
30.0%
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 27
Corporate Release No 747/2023
4 NOTES
4.1 BASIS OF PREPARATION
The interim condensed consolidated financial statements for the nine months ended September 30, 2023, have
been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the EU and additional Danish
disclosure requirements for interim financial reporting 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 at December 31, 2022,
published February 8, 2023. The accounting policies, judgements and significant estimates are consistent with those
applied in the Annual Report 2022.
Further IAS 34 disclosure requirements for interim financial reporting are included in section 2, Business
Performance. For disclosures regarding revenue and segment information see section 2.1 Revenue by product and
section 2.2 Revenue by geographical area, for disclosures regarding inventory obsolescence see section 2.4 EBIT
and adjusted EBITDA and for disclosures regarding pending legal proceedings (contingent liabilities) see section
2.11 General corporate matters.
A number of new amendments came into effect from January 1, 2023. The Group did not have to change its
accounting policies or make retrospective adjustments as a result of adopting these amended standards.
4.2 FAIR VALUE MEASUREMENT
Financial assets and financial liabilities measured or disclosed at fair value
DKK million
September 30, 2023
Level 1
Level 2
Level 3
Financial assets
Other financial assets
1
35
-
29
Derivatives
1
-
116
69
Total
35
116
98
Financial liabilities
Contingent consideration
1
-
-
346
Derivatives
1
-
198
-
Bond debt²
3,244
-
-
Total
3,244
198
346
1
Measured at fair value
2
Disclosed at fair value
The fair value of listed 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. The fair value of other financial assets is calculated through the financial performance of the market
inputs (i.e. interest swap rates) and other market conditions prevailing at the balance sheet date.
4.3 ADJUSTED EBITDA
For the financial guidance for 2023 and onwards, Lundbeck will focus on revenue performance and adjusted
EBITDA.
Lundbeck’s previous performance measure (Core EBIT) adjusted for amortization of product rights and for each
non-recurring item that Management deemed exceptional and/or which accumulates or was expected to accumulate
to DKK 100 million.
Adjusted EBITDA provides an improved and more consistent indicator, measuring the underlying operational
profitability. Adjusted EBITDA enables a better understanding of the underlying operational performance, as the
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 28
Corporate Release No 747/2023
operating result is adjusted to exclude depreciation and amortization, impairment losses and reversals of impairment
losses, as well as adjustments restricted to the following categories:
• Integration expenses,
• Restructuring expenses,
• Gains/losses on divestment of businesses,
• Acquisition expenses,
• Other adjustments.
Adjusted EBITDA, adjusted gross profit and adjusted EPS are non-IFRS performance measures.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2023 Page 29
Corporate Release No 747/2023
FINANCIAL CALENDAR 2024
February 6, 2024: Deadline for the company’s receipts of shareholder proposals for the Annual General
Meeting 2024
February 7, 2024: Corporate release for the full year 2023
February 7, 2024: Annual Report 2023
March 20, 2024: Lundbeck Annual General Meeting 2023
March 25, 2024: Dividends for 2023 at the disposal of shareholders (if proposed/approved)
May 15, 2024: Financial statements for the first three months of 2024
August 21, 2024: Financial statements for the first six months of 2024
November 13, 2024: Financial statements for the first nine months of 2024
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 30 83 30 24
Sophia Nørskov Bech
Senior Manager, Investor Relations
SONQ@lundbeck.com
+45 30 83 24 60
About Lundbeck
H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC) is a global pharmaceutical company specialized in
brain diseases. 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 5,700 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 18.2 billion in 2022 (EUR ~2.5 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) and via LinkedIn.
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