CORPORATE RELEASE
15 MAY 2024
Corporate Release No 757/2024
Financial report for the period 1 January to 31 March 2024
Lundbeck grows strategic brands by +17% CER reaching total revenue of
DKK 5.3 billion in the first quarter of 2024
Key highlights
Lundbeck’s revenue increased by 7% CER
1
(+5% DKK) to DKK 5,288 million in the first quarter of 2024, mainly
driven by growth in the U.S. and Europe
• United States: DKK 2,498 million (+9% CER; +7% DKK)
• Europe: DKK 1,248 million (+9% CER; +6% DKK)
• International Markets: DKK 1,481 million (+4% CER; -1% DKK)
The revenue of Lundbeck’s strategic brands increased by 17% CER (+15% DKK), reaching DKK 3,759 million,
representing 71% of total revenue
• Brintellix
®
/Trintellix
®
: DKK 1,168 million (+11% CER; +8% DKK)
• Rexulti
®
: DKK 1,115 million (+7% CER; +5% DKK)
• Abilify Maintena
®
/Asimtufii: DKK 859 million (+10% CER; +9% DKK)
• Vyepti
®
: DKK 617 million (+79% CER; +76% DKK)
Adjusted EBITDA
2
decreased to DKK 1,746 million (-2% CER; -5% DKK) as a result of a lower adjusted gross
margin, following quarterly fluctuations in stock valuation. In addition, the first quarter of 2024 reflects higher R&D
costs to support the pipeline in progress and targeted investments in sales and promotion mainly for Rexulti
®
and
Vyepti
®
in the U.S.
Adjusted EBITDA margin reached 33.0% equivalent to a decrease of 3.6 percentage points. Adjusted earnings per
share (EPS) reached DKK 1.38 (+1%). Excluding the effect from quarterly fluctuations in stock valuation, the
underlying growth in the adjusted EBITDA was 6% CER, constituting an adjusted EBITDA margin decrease of 0.6
percentage points.
In connection with the corporate release, Lundbeck’s President and CEO, Charl van Zyl said:
“I am pleased to present another solid quarter for Lundbeck with a robust operational performance and a 7%
revenue growth driven by the continued strong performance of our strategic brands. In line with our Focused
Innovator strategy, we are driving forward promising scientific innovations such as our potential first-in-class therapy
for migraine prevention, anti-PACAP, and a possible first treatment option targeting the rare neurological condition,
Multiple System Atrophy.”
Key figures
1
Change at CER (Constant Exchange Rates) 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
Q1 2024
Q1 2023
Change
(CER)
1
Change
(DKK)
Revenue
5,288
5,044
7%
5%
EBITDA
1,746
1,744
4%
0%
Adjusted EBITDA
1,746
1,845
(2%)
(5%)
EPS (DKK)
1.01
0.89
13%
Adjusted EPS (DKK)
1.38
1.36
1%
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 2
Corporate Release No 757/2024
Recent events
On 30 April 2024, U.S. Food and Drug Administration (FDA) communicated to Lundbeck that Lu AF82422 orphan
drug designation request has been granted for treatment of Multiple System Atrophy (MSA).
On 9 April 2024, Lundbeck and Otsuka Pharmaceutical Co., Ltd. submitted a supplemental New Drug Application
(sNDA) for U.S. FDA review of brexpiprazole as combination therapy with sertraline for the treatment of post-
traumatic stress disorder (PTSD) in adults. The sNDA submission is based on previously disclosed results, including
data from the two clinical phase III trials and the clinical phase II trial. All three trials investigated the treatment of
PTSD in adults treated with brexpiprazole in combination with sertraline versus sertraline plus placebo.
On 27 March 2024, Lundbeck and Otsuka Pharmaceutical Europe Ltd. announced that the European Commission
(EC) has approved Abilify Maintena
®
960 mg (aripiprazole) as a once-every-two-months long-acting injectable (LAI)
formulation for the maintenance treatment of schizophrenia in adult patients stabilized with aripiprazole. The EC
decision applies to all European Union (EU) member states, as well as Iceland, Norway and Liechtenstein.
On 15 March 2024, Lundbeck announced the advancement of the clinical development of Lu AG09222 for migraine
prevention with the initiation of PROCEED, a randomized, double-blind, phase IIb, dose-finding trial to assess
efficacy and safety of multiple subcutaneously administered doses. The PROCEED trial builds on the positive results
of the HOPE phase IIa Proof-of-Concept trial demonstrating efficacy of intravenously administered Lu AG09222 in
migraine prevention.
On 5 March 2024, Lundbeck announced clinical data from the AMULET phase II, double-blind, randomized trial of
Lu AF82422 in MSA at the International Conference on Alzheimer's and Parkinson's Diseases and related
neurological disorders (AD/PD 2024). Based on the encouraging AMULET trial outcomes, Lundbeck plans to initiate
a phase III study, following further dialogue with health authorities.
Lundbeck announced key leadership changes on 23 February 2024. Michala Fischer-Hansen joined as Executive
Vice President and Head of Europe & International Markets. Additionally, Tine Østergaard Hansen and Dianne Hol
were appointed Senior Vice President of Corporate Communication & Public Affairs and Executive Vice President
of People & Organization, respectively. Furthermore, on 13 May 2024, Lundbeck announced the appointment of
Maria Alfaiate as Executive Vice President Commercial and Corporate Strategy.
Financial guidance 2024 maintained
On 7 February 2024, Lundbeck communicated the financial guidance for 2024 focusing on revenue performance
and adjusted EBITDA at CER.
The revenue growth is expected to be 7% to 10% at CER when compared to revenue of the prior year excluding
the effect from hedging. The adjusted EBITDA growth is expected to be 10% to 16% at CER when compared to
adjusted EBITDA of the prior year excluding effects from hedging. Further details are available in section 2.7
Outlook.
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 1 JANUARY TO 31 MARCH 2024 Page 3
Corporate Release No 757/2024
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 Outlook ......................................................................................................................................................... 11
2.8 Lundbeck’s development portfolio ................................................................................................................ 13
2.9 Sustainability update .................................................................................................................................... 14
2.10 General corporate matters ......................................................................................................................... 16
3 Condensed financial statements .......................................................................................................................... 19
4 Notes ................................................................................................................................................................... 24
Financial calendar 2024 .......................................................................................................................................... 26
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 4
Corporate Release No 757/2024
1 FINANCIAL HIGHLIGHTS
For the three months ended 31 March
DKK million
Q1 2023
Change
(CER)
1
Change
(DKK)
Revenue
5,044
7%
5%
Gross profit
4,003
9%
7%
Gross margin
79.4%
Adjusted gross profit
2
4,568
5%
3%
Adjusted gross margin
90.6%
Sales and distribution costs
1,673
9%
7%
S&D ratio
33.2%
Administrative expenses
258
2%
0%
Administrative expenses ratio
5.1%
Research and development costs
839
14%
14%
R&D ratio
16.6%
EBIT (profit from operations)
1,233
9%
4%
EBIT margin
24.4%
EBITDA
3
1,744
4%
0%
EBITDA margin
34.6%
Adjusted EBITDA
4
1,845
(2%)
(5%)
Adjusted EBITDA margin
36.6%
Net financials, (income)/expenses
83
-
135%
Profit before tax
1,150
-
14%
Income taxes
270
-
11%
Effective tax rate (reported)
23.5%
Net profit
880
-
14%
Adjusted net profit
1,355
-
1%
Other key numbers
Assets
36,624
-
3%
Equity
20,980
-
7%
Cash flows from operating and investing activities
(free cash flow)
301
-
188%
Net cash flow for the period
(654)
-
116%
Return on invested capital – rolling four quarters
10.5%
Net debt/EBITDA – rolling four quarters
0.5
-
(140%)
Number of shares for the calculation of EPS (millions)
992.9
-
0%
Earnings per share, basic (EPS) (DKK)
0.89
-
13%
Adjusted earnings per share, basic (DKK)
1.36
-
1%
1
Change at CER (Constant Exchange Rates) 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 1 JANUARY TO 31 MARCH 2024 Page 5
Corporate Release No 757/2024
2 BUSINESS PERFORMANCE
2.1 REVENUE BY PRODUCT
Revenue reached DKK 5,288 million representing a
growth of 7% CER (+5% DKK). The revenue growth
is driven by the strong performance of the strategic
brands reaching DKK 3,759 million, representing a
growth of 17% CER (+15% DKK) and equivalent to
71% of total revenue. The largest markets for the
strategic brands are the U.S., Canada, Spain, Italy
and France.
DKK million
Q1 2024
Q1 2023
Growth
(CER)
Growth
(DKK)
Brintellix
®
/Trintellix
®
1,168
1,077
11%
8%
Rexulti
®
1,115
1,060
7%
5%
Abilify Maintena
®
/Asimtufii
859
785
10%
9%
Vyepti
®
617
351
79%
76%
Strategic brands
3,759
3,273
17%
15%
Cipralex
®
/Lexapro
®
618
664
1%
(7%)
Other pharmaceuticals
850
1,073
(18%)
(21%)
Mature brands
1,468
1,737
(11%)
(15%)
Other revenue
70
63
11%
11%
Total revenue before hedging
5,297
5,073
7%
4%
Effects from hedging
(9)
(29)
Total revenue
5,288
5,044
7%
5%
Strategic brands
Brintellix
®
/Trintellix
®
(vortioxetine) is approved for
the treatment of MDD. Revenue reached DKK 1,168
million representing a growth of 11% CER (+8%
DKK), contributed by all regions, with strong
performance in Europe, driven by higher demand,
with solid contribution from Spain. In the U.S., growth
was driven by price increase, offset by lower demand.
The continued higher sales in Japan also contributed
to the growth in International Markets. The revenue
distribution by region was 31%, 36% and 33% in the
U.S., Europe and International Markets, respectively.
The largest markets for the product are the U.S.,
Spain, Canada, Italy and Brazil.
Rexulti
®
(brexpiprazole) is approved as an adjunctive
therapy for the treatment of adults with major
depressive disorder (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. Following the approval, the brand
has seen a continued strong growth in latest claims
data especially led by the strong uptake in long-term-
care facilities. In addition, AADAD has been approved
in Canada and has been filed in certain other
countries. In Australia and Europe, the product is
approved for schizophrenia. Revenue reached DKK
1,115 million representing a growth of 7% CER (+5%
DKK), contributed by all the regions. In the U.S., sales
performance was mainly driven by continued growth
following the AADAD approval, however growth for
the brand in the U.S. has been negatively impacted
by a temporary suspension of Direct-to-consumer
(DTC) spend in MDD since November 2023. The
activity has restarted in February 2024. In Europe and
International Markets, sales growth was driven by
higher demand. The revenue distribution by region
was 91%, 2% and 7% in the U.S., Europe and
International Markets, respectively. The largest
markets are the U.S., Brazil, Canada, Australia and
Mexico.
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. In
March 2024, the European Commission (EC)
approved Abilify Maintena
®
960 mg (aripiprazole) as
a once-every-two-months long-acting injectable (LAI)
formulation for the maintenance treatment of
schizophrenia in adult patients stabilized with
aripiprazole. This applies to all EU member states, as
well as Iceland, Norway and Liechtenstein. In April
2023, FDA approved a New Drug Application (NDA)
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 6
Corporate Release No 757/2024
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 859 million
representing a growth of 10% CER (+9% DKK)
contributed by all regions. In the U.S., sales growth
was mainly driven by higher demand for Abilify
Asimtufii
®
. In Europe, sales growth was driven by
higher demand. The continued demand uptake in
Canada also contributed strongly to International
Markets sales growth. The revenue distribution by
region was 35%, 47% and 18% in the U.S., Europe
and International Markets, respectively. The largest
markets are the U.S., Spain, Canada, Australia and
Italy.
Vyepti
®
(eptinezumab) is approved as a preventive
treatment of migraine in adults. Vyepti
®
delivered
significant growth in the first quarter of 2024 and
revenue reached DKK 617 million following an
increase of 79% CER (+76% DKK) across all the
regions. In the U.S., Vyepti
®
sales growth was mainly
driven by prescription volume growth and market
share gains, reflecting the continued demand uptake
of Vyepti
®
. In Europe and International Markets, sales
growth was driven by market share gains as part of
the continued demand uptake, with strong
performance in Canada as well as the launches
across the world. Vyepti
®
was initially launched in
April 2020 in the U.S. and has since been launched
in around 25 markets in total. In October 2023,
Vyepti
®
received public formulary coverage from
certain provinces in Canada. Combined, this
coverage allows more than 80% of eligible Canadian
patients living with migraine to have access to
Vyepti
®
. The revenue distribution by region was 88%,
7% and 5% in the U.S., Europe and International
Markets, respectively.
Mature brands
Cipralex
®
/Lexapro
®
(escitalopram) is approved for
the treatment of MDD. Revenue reached DKK 618
million representing a growth of 1% CER (-7% DKK)
mainly due to strong performance in-market sales in
China and price increase in Turkey due to inflation,
partially offset by continued erosion in Japan and
Switzerland. The revenue distribution by region was
73% and 27% in International Markets and Europe,
respectively. The largest markets are China, Saudi
Arabia, Brazil, South Korea and Italy.
Revenue from Other pharmaceuticals, which
comprises the remainder of Lundbeck’s products,
reached DKK 850 million representing a decline of
18% CER (-21% DKK), mainly due to lower sales of
certain mature products such as Northera
®
,
Sabril
®
and Deanxit
®
. As of 1 January 2024, Sabril
®
is being
reported together with Other pharmaceuticals,
comparative figures for 2023 have been adjusted
accordingly. The largest markets for Other
pharmaceuticals are the U.S, China, France, South
Korea and Thailand.
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 7
Corporate Release No 757/2024
2.2 REVENUE BY GEOGRAPHICAL AREA
DKK million
Q1 2024
Q1 2023
Growth
(CER)
Growth
(DKK)
United States
Rexulti
®
1,018
979
6%
4%
Vyepti
®
544
328
69%
66%
Trintellix
®
358
338
7%
6%
Abilify Maintena
®
/Asimtufii
301
282
9%
7%
Strategic brands
2,221
1,927
17%
15%
Mature brands
277
410
(31%)
(32%)
Revenue – United States
2,498
2,337
9%
7%
Europe
Brintellix
®
423
371
16%
14%
Abilify Maintena
®
400
355
12%
13%
Vyepti
®
45
12
275%
275%
Rexulti
®
18
13
38%
38%
Strategic brands
886
751
19%
18%
Mature brands
362
423
(9%)
(14%)
Revenue – Europe
1,248
1,174
9%
6%
International Markets
Brintellix
®
/Trintellix
®
387
368
10%
5%
Abilify Maintena
®
158
148
10%
7%
Rexulti
®
79
68
21%
16%
Vyepti
®
28
11
155%
155%
Strategic brands
652
595
14%
10%
Mature brands
829
904
(2%)
(8%)
Revenue – International Markets
1,481
1,499
4%
(1%)
Other revenue
70
63
11%
11%
Total revenue before hedging
5,297
5,073
7%
4%
Effects from hedging
(9)
(29)
Total revenue
5,288
5,044
7%
5%
Lundbeck’s largest markets are the U.S., China,
Canada, Spain and Italy.
United States revenue reached DKK 2,498 million
representing a growth of 9% CER (+7% DKK). The
strategic brands reached DKK 2,221 million
increasing by 17% CER (+15% DKK), representing
89% of the revenue. The revenue growth is mainly
driven by the continued demand uptake of Vyepti
®
.
Additionally, strategic brands were positively
impacted by continued growth since the AADAD
approval. Mature brands such as Northera
®
, Onfi
®
and Sabril
®
have been impacted by lower sales.
Europe revenue reached DKK 1,248 million
representing a growth of 9% CER (+6% DKK). The
strategic brands reached DKK 886 million increasing
19% CER (+18% DKK), representing 71% of
revenue. The revenue growth is mainly driven by
higher demand for Brintellix
®
and Abilify Maintena
®
as
well as continued demand uptake of Vyepti
®
. Mature
brands have been impacted by continued price
pressure as well as continued erosion of certain
brands such as Cipralex
®
in Switzerland, Cipramil
®
and Cisordinol
®
. The largest markets in Europe are
Spain, Italy, France, Switzerland and Greece.
International Markets comprises all Lundbeck’s
markets outside the U.S. and Europe. Revenue
reached DKK 1,481 million representing a growth of
4% CER (-1% DKK). The strategic brands reached
DKK 652 million increasing by 14% CER (+10%
DKK), representing 44% of revenue. The revenue
growth is mainly driven by higher demand across all
four brands. Mature brands have been impacted by
ongoing erosion of certain brands such as Lexapro
®
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 8
Corporate Release No 757/2024
in Japan following the entry of generic competition
since the end of 2022 as well as the erosion of
Deanxit
®
in China. The biggest markets are China,
Canada, Brazil, Saudi Arabia and Australia. China
and Canada constitute approximately 41% of the
regional revenue.
Effects from hedging
Lundbeck hedges a significant part of the currency
risk for a period of 12 – 18 months. Hedging had a
negative impact of DKK 9 million in the first quarter of
2024, compared to a negative impact of DKK 29
million in the same period last year.
2.3 GROSS PROFIT
DKK million
Q1 2024
Q1 2023
Change
(CER)
Change
(DKK)
Revenue
5,288
5,044
7%
5%
Cost of sales
1,009
1,041
0%
(3%)
thereof adjustments
-
101
-
-
thereof amortization of product rights
368
404
(8%)
(9%)
thereof depreciation/amortization
53
60
(12%)
(12%)
Gross profit
4,279
4,003
9%
7%
Gross margin (%)
80.9%
79.4%
Adjusted gross profit
4,700
4,568
5%
3%
Adjusted gross margin (%)
88.9%
90.6%
Cost of sales reached DKK 1,009 million and
remained unchanged at CER (-3% DKK) mainly
driven by higher sales, offset by lower amortization
due to fully amortized product rights in the first quarter
of 2024. The first quarter of 2023 was impacted by
the negative effect of Vyepti
®
inventory obsolescence
of DKK 101 million and a favourable effect from
quarterly fluctuations in stock valuation.
Gross profit reached DKK 4,279 million, increasing
by 9% CER (+7% DKK). The gross margin was
80.9% representing an increase of 1.5 percentage
points. The increase was mainly driven by higher
sales as well as the effect of lower amortization costs
in the first quarter of 2024. The first quarter of 2023
was impacted by the negative effect of Vyepti
®
inventory obsolescence and a favourable effect from
quarterly fluctuations in stock valuation.
Adjusted gross profit is the gross profit excluding
depreciation and amortization and other adjustments
linked to sales. The adjusted gross margin was
88.9% representing a decrease of 1.7 percentage
points. The decrease reflects mainly higher sales and
the effect of a favourable effect from quarterly
fluctuations in stock valuation.
Amortization of product rights was DKK 368 million,
decreasing by 8% CER (-9% DKK).
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 9
Corporate Release No 757/2024
2.4 EBIT AND ADJUSTED EBITDA
DKK million
Q1 2024
Q1 2023
Change
(CER)
Change
(DKK)
Revenue
5,288
5,044
7%
5%
Gross profit
4,279
4,003
9%
7%
thereof adjustments
-
101
-
-
thereof depreciation/amortization
421
464
(9%)
(9%)
Sales and distribution costs
1,789
1,673
9%
7%
thereof depreciation/amortization
22
24
(8%)
(8%)
S&D-ratio
33.8%
33.2%
Administrative expenses
259
258
2%
0%
thereof depreciation/amortization
5
5
0%
0%
Administrative expenses ratio
4.9%
5.1%
Research and development costs
953
839
14%
14%
thereof depreciation/amortization
20
18
11%
11%
R&D-ratio
18.0%
16.6%
Total operating expenses
3,001
2,770
10%
8%
OPEX-ratio
56.8%
54.9%
EBIT (profit from operations)
1,278
1,233
9%
4%
Depreciation/amortization
468
511
(8%)
(8%)
EBITDA
1,746
1,744
4%
0%
EBITDA margin (%)
33.0%
34.6%
Other adjustments
-
101
-
-
Adjusted EBITDA
1,746
1,845
(2%)
(5%)
Adjusted EBITDA margin (%)
33.0%
36.6%
Total operating expenses (OPEX) reached DKK
3,001 million corresponding to an increase of 10%
CER (+8% DKK) mainly driven by higher sales and
distribution costs as well as R&D costs. The OPEX-
ratio increased by 1.9 percentage points.
Sales and distribution costs reached DKK 1,789
million corresponding to an increase of 9% CER
(+7% DKK) reflecting the continued investments in
sales and promotion activities in strategic brands
such as Rexulti
®
and Vyepti
®
in the U.S. and the
global roll-out of Vyepti
®
.
Sales and distribution costs corresponded to 33.8%
of revenue, representing an increase of 0.6
percentage points.
Administrative expenses reached DKK 259 million,
increasing by 2% CER (0% DKK) corresponding to
4.9% of total revenue.
Research and development costs reached DKK
953 million with an R&D ratio of 18.0%. Higher R&D
costs of 14% CER (+14% DKK) reflects mainly
investments in Lundbeck’s progressing pipeline
encompassing eight projects. Further details are
available in section 2.8 Lundbeck’s development
portfolio. The main development in R&D costs comes
from the progression of the phase II pipeline with
initiation of a phase IIb dose finding trial for anti-
PACAP and phase III preparations for Lu AF82422
(anti-alpha-synuclein mAb).
EBIT reached DKK 1,278 million, increasing by 9%
CER (+4% DKK) reflecting the operating leverage
effect of higher revenue and lower product rights
amortization, offset by higher operating expenses
regarding investments in sales and distribution and
R&D costs. Furthermore, EBIT for the first quarter of
2023 was negatively affected by the recognition of a
provision of DKK 101 million for Vyepti
®
inventory
obsolescence and a favourable effect from quarterly
fluctuations in stock valuation.
Amortization of product rights amounted to DKK
368 million corresponding to a decrease of 8% CER
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 10
Corporate Release No 757/2024
(-9% DKK). Total amortization, depreciation and
impairment losses reached DKK 468 million
representing a decrease of 8% CER (-8% DKK)
mainly driven by a decrease in the amortization
recognized in the first quarter of 2024 due to fully
amortized product rights.
Adjusted EBITDA reached DKK 1,746 million
representing a decline of 2% CER (-5% DKK)
reflecting EBIT and EBITDA development.
Excluding the favourable effect from quarterly
fluctuations in stock valuation, the underlying growth
in the adjusted EBITDA was 6% CER, constituting an
adjusted EBITDA margin decrease of 0.6 percentage
points.
2.5 NET PROFIT AND ADJUSTED EPS
DKK million
Q1 2024
Q1 2023
Change
(DKK)
EBIT (profit from operations)
1,278
1,233
4%
Net financials, (income)/expenses
(29)
83
135%
Profit before tax
1,307
1,150
14%
Net profit
1,006
880
14%
thereof other adjustments
-
101
-
thereof depreciation/amortization
468
511
(8%)
thereof tax on adjustments
103
137
(25%)
EPS (DKK)
1.01
0.89
13%
Adjusted net profit
1,371
1,355
1%
Adjusted EPS (DKK)
1.38
1.36
1%
Net profit
Net financial expenses amounted to an income of
DKK 29 million equivalent to an increase of 135% due
to the positive development in interest expenses,
favourable currency impact as well as lower interest-
bearing debt.
The effective tax rate for the first quarter of 2024
was 23.0% (23.5% for the first quarter of 2023). The
tax rate is in line with the full-year expectation.
Net profit reached DKK 1,006 million corresponding
to a growth of 14%.
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 1,371
million, representing an increase of 1%. The
adjustments are mainly related to amortization of
product rights in the first quarter of 2024.
Adjusted EPS was DKK 1.38 corresponding to an
increase of 1%.
2.6 CASH FLOW AND BALANCE SHEET
DKK million
Q1 2024
Q1 2023
Profit from operations (EBIT)
1,278
1,233
Cash flows from operating activities
961
378
Cash flows from investing activities
(94)
(77)
Cash flows from operating and investing activities (free cash flow)
867
301
Cash flows from financing activities
(760)
(955)
Net cash flow for the period
107
(654)
Cash flows from operating activities amounted to
an inflow of DKK 961 million compared to an inflow of
DKK 378 million in the first quarter of 2023 mainly
driven by a combination of higher EBIT, lower
inventory build-up and lower short-term liabilities due
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 11
Corporate Release No 757/2024
to Rexulti
®
milestone paid-out in the first quarter of
2023.
Lundbeck’s net cash flows from investing
activities were an outflow of DKK 94 million
compared to an outflow of DKK 77 million in the first
quarter of 2023. The investing activities mainly
include capital expenditures in property, plant and
equipment as well as intangible assets.
Lundbeck’s net cash flows from financing
activities were an outflow of DKK 760 million
compared to an outflow of DKK 955 million in the first
quarter of 2023 mainly relate to repayment of debt,
offset by higher dividend paid in March 2024.
The net cash inflow reached DKK 107 million
compared to an outflow of DKK 654 million in the first
quarter of 2023.
Net debt has decreased from DKK 2,491 million at
the end of March 2023 to net cash of DKK 799 million
at the end of March 2024. Net debt/EBITDA ratio is
-0.2x at the end of March 2024 compared to 0.5x at
the end of March 2023. Interest-bearing debt was
DKK 4,314 million at the end of March 2024
compared to DKK 5,373 million at the end of March
2023.
On 31 March 2024, Lundbeck’s total assets
amounted to DKK 37,852 million compared to DKK
37,407 million at the end of 2023.
On 31 March 2024, Lundbeck’s equity amounted to
DKK 22,435 million.
2.7 OUTLOOK
Financial guidance 2024
On 7 February 2024, Lundbeck communicated the
financial guidance for 2024 focusing on revenue
performance and adjusted EBITDA at CER.
Lundbeck maintains its full year guidance for 2024,
where revenue is expected to grow 7% to 10% at
CER when compared to revenue of the prior year
excluding effects from hedging. Assuming the current
exchange rates versus DKK, the revenue growth
reported in DKK is expected to be around 3
percentage points lower than at CER. Lundbeck
expects revenue growth is mainly driven by the
demand of the strategic brands.
The guidance range reflects continued strong growth
of Vyepti
®
in the U.S. and the continued global roll-
out. Additionally, the guidance expects robust growth
of Rexulti
®
following AADAD indication in the U.S.
Furthermore, the guidance range comprises growth
of Brintellix
®
in Europe and International Markets as
well as slight growth for Abilify Maintena
®
/Asimtufii in
the U.S.
For the financial guidance for 2024, published in
February 2024, Lundbeck expected the most relevant
generic erosion impacts for the year coming from
brands such as Cipralex
®
/Lexapro
®
, Deanxit
®
and
Sabril
®
. For the coming quarters, Lundbeck expects
slightly growth to Cipralex
®
/Lexapro
®
and Deanxit
®
as
well as lower level of erosion for Sabril
®
despite
higher than expected generic erosion from Northera
®
and Xenazine
®
.
Adjusted EBITDA is expected to grow 10% to 16% at
CER in 2024 when compared to adjusted EBITDA of
the prior year excluding effects from hedging.
Assuming the current exchange rates versus DKK,
the adjusted EBITDA growth reported in DKK is
expected to be around 8 percentage points lower
than at CER. Lundbeck expects higher R&D costs
driven by the progression of the pipeline, higher sales
and distribution costs due to increased Vyepti
®
and
Rexulti
®
promotion activities.
Lundbeck mainly carries foreign currency risk in USD,
CNY, CAD, BRL and AUD. Other relevant financial
information for FY 2024 at reported rates presented
below has been monitored and reviewed considering
actual exchange rates for the period already incurred
and the following estimated exchanges rates for the
remaining period of the year: USD/DKK (6.90);
CNY/DKK (0.95); CAD/DKK (5.09); BRL/DKK (1.38);
AUD/DKK (4.49).
All the above expectations are based on assumptions
that the global or regional macroeconomic and
political environment will not significantly change
business conditions for Lundbeck during 2024,
including the impact of any potential material
business development activities and the potential
implications.
In the table below, the expectations and additional
relevant information have been summarized.
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 12
Corporate Release No 757/2024
Revenue at CER
DKK million
Q1 2024
Total revenue (IFRS)
5,288
Effects from hedging
(9)
Total revenue (IFRS) before hedging
5,297
Effects from exchange rate
(154)
Total revenue at CER
5,451
Increase/(decrease) in total revenue
5%
Increase/(decrease) in total revenue at CER
1
7%
1
Total revenue at CER for the period divided by total revenue (IFRS) before hedging for the comparative period.
Adjusted EBITDA at CER
DKK million
Q1 2024
Adjusted EBITDA
1,746
Effects from hedging
(9)
Adjusted EBITDA before hedging
1,755
Effects from exchange rate
(87)
Adjusted EBITDA at CER
1,842
Increase/(decrease) in adjusted EBITDA
(5%)
Increase/(decrease) in adjusted EBITDA at CER
1
(2%)
1
Adjusted EBITDA at CER for the period divided by adjusted EBITDA before hedging for the comparative period.
Mid-term targets
Lundbeck’s mid-term targets communicated in
February 2023 remain unchanged. Lundbeck is in a
period with limited impact from major regional losses
of exclusivity and anticipates solid growth of its
strategic brands.
In 2024 and 2025, Lundbeck plans 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 next three 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 material business development
activities, by the end of the mid-term period (2026).
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,
Financial guidance for 2024
As of 7 February 2024
Total revenue growth at CER
7% to 10%
Adjusted EBITDA growth at CER
10% to 16%
Other relevant financial information for FY 2024 at reported rates
Total revenue (IFRS) growth
1
Around 3 percentage points lower than at CER
Adjusted EBITDA growth
1
Around 8 percentage points lower than at CER
Adjusted gross margin
2
88% to 89%
R&D costs
DKK 3.9 to 4.1 billion
Depreciation & amortization
DKK 1.8 to 2.0 billion
Net financials, expenses
DKK 0 to 50 million
Effects from hedging
DKK -130 to -155 million
Effective tax rate
22% to 24%
Net cash/(net debt)
3
DKK 4.2 to 4.7 billion
1
Includes effects from hedging and exchange rate impact.
2
Adjusted gross margin is the gross margin excluding depreciation and amortization and other adjustments linked to sales.
3
Net cash/(net debt) is defined as Interest-bearing debt, cash, cash equivalents and securities, net.
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 13
Corporate Release No 757/2024
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.
2.8 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”).
Hormonal / neuropeptide signalling
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
(anti-PACAP mAb). PACAP and its receptors are
broadly expressed in the nervous systems and
inflammatory cells. By interfering with the PACAP
signalling there is a potential to affect multiple
symptoms of headache disorders.
Lundbeck has initiated the PROCEED trial, a phase
IIb trial with subcutaneously administered Lu
AG09222 that builds on the positive results of the
HOPE trial.
PROCEED is an interventional, randomized, double-
blind, parallel-group, placebo-controlled, dose-finding
phase IIb trial that will be conducted in Europe, Japan
and the U.S. It assesses four different doses of Lu
AG09222 versus placebo, administered
subcutaneously once monthly for three months. The
trial is intended to establish the optimal dose for
future global pivotal trials designed to confirm the
efficacy and safety of Lu AG09222 as a migraine
preventive treatment. PROCEED is planned to enrol
approximately 498 patients and will assess the
efficacy, safety and tolerability of Lu AG09222. The
target population for this trial is defined as patients
diagnosed with migraine as outlined in the
International Classification of Headache Disorders
Third Edition (ICHD-3) and with failure to 2-4 different
preventive migraine medications in the past 10 years.
Study completion is expected in H2 2025.
Circuitry / neuronal biology
Brexpiprazole – phase III in Post-Traumatic
Stress Disorder (PTSD)
On 7 September 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. The
safety and tolerability results were consistent with the
profile of brexpiprazole as observed in the clinical
trials for schizophrenia, AADAD and adjunctive
treatment of MDD.
On 9 April 2024 Lundbeck submitted a supplemental
New Drug Application (sNDA) for U.S. Food and Drug
Administration (FDA) review of brexpiprazole as
Project
Area
Phase I
Phase II
Phase III
Filing/
Launch
Hormonal / neuropeptide signalling:
Eptinezumab (anti-CGRP)
1
Migraine prevention
SUN-studies
2
Cluster headache
CHRONICLE
3
ALLEVIATE
Lu AG09222 (anti-PACAP mAb)
4
Migraine prevention
PROCEED
Lu AG13909 (anti-ACTH mAb)
5
Neuro-hormonal dysfunctions
Circuitry / neuronal biology:
Brexpiprazole
6
PTSD
MAGLi programs
7
Neurology
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 AG22515 (anti-CD40L blocker)
Neurology
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 14
Corporate Release No 757/2024
combination therapy with sertraline for the treatment
of Post-Traumatic Stress Disorder (PTSD) in adults.
FDA validation of the submission dossier, prior to
FDA’s decision whether to proceed with a full review,
is expected in June 2024 including information on
whether FDA assigns priority or standard review.
The sNDA submission is based on the two recently
completed clinical phase III trials and a phase trial,
which all investigated the treatment of PTSD in adults
treated with brexpiprazole in combination with
sertraline versus sertraline plus placebo. Detailed
data from all three trials will be presented at the
American Society of Clinical Psychopharmacology
(ASCP) 28 – 31 May 2024 in Miami, Florida.
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. A phase II randomized,
double-blind, placebo-controlled exploratory proof-of-
concept (PoC) trial (AMULET) testing Lu AF82422 in
MSA patients was initiated in November 2021
(NCT05104476) in the U.S and Japan.
In January 2024, Lundbeck announced results of the
AMULET PoC trial. The trial included 61 MSA
patients randomized 2:1 (40 on Lu AF82422 versus
21 on placebo) and treated for 48-72 weeks. The
primary endpoint in the trial measured slowing of
progression of MSA as measured by Unified Multiple
System Atrophy Rating Scale (UMSARS) Total Score
Part I and II, while the key secondary endpoints
included Modified UMSARS Part I as well as several
other clinical outcome measures and biomarkers.
The primary statistical approach consisted of a
Bayesian slope analysis. While the trial did not reach
statistical significance on its primary endpoint, a trend
towards slowing MSA disease progression was
observed in the group exposed to Lu AF82422
compared to the placebo group, and additional
signals of efficacy were observed across other clinical
and biomarker endpoints. Lu AF82422 was generally
well tolerated. Lundbeck plans to initiate a phase III
study, following further dialogue with health
authorities.
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. In April 2024, Lundbeck
also obtained orphan drug designation for the Lu
AF82422 in MSA by the FDA.
2.9 SUSTAINABILITY UPDATE
Lundbeck’s sustainability strategy aims to ensure that
we mitigate our most significant sustainability risks
and adverse impacts, while acting on the
opportunities to make a positive impact on the
environment, patients and the communities.
In this sustainability update, progress is presented for
Environmental, Social and Governance matters
supported by key performance metrics.
ENVIRONMENTAL PERFORMANCE
Category
1
Q1 2024
Q1 2023
2
Change (%)
Scope 1 GHG emissions (Tonne CO₂ₑ)
5,983
5,917
1%
Scope 2 GHG emissions (Market Based) (Tonne CO₂ₑ)
1,122
974
15%
Scope 1+2 GHGs (Tonne CO2e)
7,105
6,891
3%
Energy consumption (MWh)
32,411
30,736
5%
1
See Lundbeck Sustainability Report 2023 for accounting policies and definitions.
2
All comparative figures were updated to reflect changes in estimates.
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 15
Corporate Release No 757/2024
Climate Action
Lundbeck is committed to protecting the environment
and believes that a healthy environment is a
precondition for good health and wellbeing. Lundbeck
has targets to reduce its total carbon footprint across
its own operations, supply chain, and distribution.
In the quarter of 2024, Scope 1 + 2 GHG emissions
increased by 3%, compared to the first quarter of
2023. Scope 1 and Scope 2 emissions increased by
1% and 15%, respectively, due to the
commencement of operation of a new production unit
at our production site in Padova (Italy).
Despite the increased emissions in the first quarter of
2024, Lundbeck remains on track to meet its climate
targets, as the planned actions in the low carbon
transition plan will come into effect.
Other topics
In 2022, traces of PFAS (per- and polyfluoroalkyl
substances) were found at Lundbeck’s Lumsås
production facility. The pollution stems from the use
of fire-retardant foam containing the PFAS type
PFOS (perfluorooctane sulfonate) until 2011, in
compliance with national fire safety and
environmental regulations at the time. Lundbeck
switched to a supply of PFOS-free fire-retardant foam
more than 11 years ago.
Since the pollution was detected, Lundbeck has been
engaged in a close dialogue with the Danish
Environmental Protection Agency (EPA) and local
authorities regarding the mapping and remediation
possibilities of the pollution.
Lundbeck received an order from the EPA with the
technical specification for environmental remediation
of one area of the site. The order requires the
installation of a pump and treat solution for subsoil
water. Lundbeck continues a close dialogue with the
authorities and affected stakeholders and keep an
eye on the development of technologies to efficiently
clean PFAS pollution from the contaminated soil and
water.
SOCIAL PERFORMANCE
Category
1
Q1 2024
Q1 2023
Change
2
Gender balance (women % in senior management)
32.9%
34.7%
(1.8)
1
See Lundbeck Sustainability Report 2023 for accounting policies and definitions.
2
Variation in percentage points.
Diversity, Equity and Inclusion
Lundbeck is a diverse company determined to build
an inclusive high-performance culture, where all
employees can enrich their professional skills and
career paths. We are committed to fostering a diverse
workforce and an inclusive culture of belonging where
everybody can thrive, be their authentic selves, and
perform at their best. This includes taking action on
gender equality, and Lundbeck has a target to
increase the share of the underrepresented gender at
senior management level year-on-year.
In the first quarter of 2024, the Gender balance in
senior management decreased to 32.9% women,
compared to 34.7% in the first quarter of 2023. The
decrease is due to changes in the Executive
Management in the end of 2023 and beginning of
2024.
Access to Brain Health
Lundbeck has a responsibility to support disease
awareness and help address the societal burden
thereof. Lundbeck has provided the Red Cross with a
grant of DKK 5 million, which will be used to expand
mental health support activities in Ukraine, such as
its psychological first aid, creating child-friendly
spaces and providing training for their volunteers and
staff.
GOVERNANCE PERFORMANCE
Category
1
Q1 2024
Q1 2023
Change (%)
Due Diligence screenings of Suppliers and Third Parties (Number)
75
52
44%
1
See Lundbeck Sustainability Report 2023 for accounting policies and definitions.
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 16
Corporate Release No 757/2024
Responsible Business Conduct
Responsible business conduct is crucial to Lundbeck
as a global pharmaceutical company. It translates
into how Lundbeck upholds stakeholder integrity and
minimizes the risk of financial repercussions.
The number of Due Diligence screenings
conducted in the first quarter of 2024 increased by
44%, compared to the first quarter of 2023. This
increase is due to continued growing awareness
across the organization on the importance of ethical
business conduct in the value chain.
2.10 GENERAL CORPORATE MATTERS
Pending legal proceedings
Lundbeck is involved in a number of legal
proceedings, including patent disputes and
environmental matters, 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 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 legal proceedings
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
defence 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 was held in April 2024 and a ruling on time-
barring is expected in the second or third quarter of
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
defence in May 2022 and the parties have
subsequently exchanged additional pleadings. The
first instance court hearing has been postponed to the
second 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
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 behaviour side
effects) and one relating to Rexulti
®
(also alleging i.a.
failure to warn about compulsive behaviour 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
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 17
Corporate Release No 757/2024
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 will
be heard on 24 August 2024, 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.
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 favour. The trial has been re-
scheduled to start on 17 June 2024 and a District
Court decision is currently expected by October 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 and is
currently under appeal.
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
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.
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 18
Corporate Release No 757/2024
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 1 January to 31 March 2024. 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 31 March 2024, and of the results of the Group’s
operations and cash flows for the period, which ended on 31 March 2024.
In our opinion, the Management’s Review (pages 5-17) 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 2023.
The financial report has not been subject to audit or reviewed by the company’s independent auditors.
Valby, 15 May 2024
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
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
Jakob Riis
Ilse Dorothea Wenzel
Camilla Gram Andersson
Employee representative
Hossein Armandi
Dorte Clausen
Lasse Skibsbye
Employee representative
Employee representative
Employee representative
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 19
Corporate Release No 757/2024
3 CONDENSED FINANCIAL STATEMENTS
CONDENSED STATEMENT OF PROFIT OR LOSS
DKK million
Q1 2024
Q1 2023
Revenue
5,288
5,044
Cost of sales
1,009
1,041
Gross profit
4,279
4,003
Sales and distribution costs
1,789
1,673
Administrative expenses
259
258
Research and development costs
953
839
Profit from operations (EBIT)
1,278
1,233
Net financials, (income)/expenses
(29)
83
Profit before tax
1,307
1,150
Tax on profit for the period
301
270
Profit for the period
1,006
880
Earnings per share, basic (EPS) (DKK)
1.01
0.89
Earnings per share, diluted (DEPS) (DKK)
1.01
0.89
STATEMENT OF COMPREHENSIVE INCOME
DKK million
Q1 2024
Q1 2023
Profit for the period
1,006
880
Actuarial gains/losses
-
-
Tax
-
-
Items that will not be reclassified subsequently to profit or loss
-
-
Exchange rate gains/losses on investments in foreign subsidiaries
236
(170)
Exchange rate gains/losses on additions to net investments in foreign subsidiaries
(40)
(1)
Hedging of net investments in foreign subsidiaries
-
18
Deferred gains/losses on cash flow hedge, exchange rate
(110)
134
Deferred gains/losses on cash flow hedge, interest rate
-
(9)
Deferred gains/losses on cash flow hedge, price
(17)
(41)
Exchange gains/losses, hedging (transferred to the hedged items)
9
29
Tax
35
(28)
Items that may be reclassified subsequently to profit or loss
113
(68)
Other comprehensive income
113
(68)
Comprehensive income
1,119
812
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 20
Corporate Release No 757/2024
CONDENSED STATEMENT OF FINANCIAL POSITION
DKK million
31.03.2024
31.12.2023
Assets
Intangible assets
20,607
20,692
Property, plant and equipment
2,509
2,499
Right-of-use assets
393
382
Other financial assets
87
99
Other receivables
228
208
Deferred tax assets
258
238
Non-current assets
24,082
24,118
Inventories
4,513
4,427
Receivables
4,144
3,852
Cash and cash equivalents
5,113
5,010
Current assets
13,770
13,289
Assets
37,852
37,407
Equity and liabilities
Share capital
996
996
Foreign currency translation reserve
1,314
1,109
Hedging reserve
(29)
63
Retained earnings
20,154
19,877
Equity
22,435
22,045
Retirement benefit obligations
221
216
Deferred tax liabilities
2,385
2,283
Provisions
413
388
Bank debt and bond debt
3,717
3,714
Lease liabilities
361
351
Other payables
451
420
Non-current liabilities
7,548
7,372
Retirement benefit obligations
1
1
Provisions
1,082
934
Trade payables
4,188
4,410
Lease liabilities
85
86
Income taxes payable
685
571
Other payables
1,828
1,988
Current liabilities
7,869
7,990
Liabilities
15,417
15,362
Equity and liabilities
37,852
37,407
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 21
Corporate Release No 757/2024
STATEMENT OF CHANGES IN EQUITY
DKK million
Share
capital
Foreign
currency
translation
reserve
Hedging
reserve
Retained
earnings
Total
equity
Equity at 1 January 2024
996
1,109
63
19,877
22,045
Profit for the period
-
-
-
1,006
1,006
Other comprehensive income
-
205
(92)
-
113
Comprehensive income
-
205
(92)
1,006
1,119
Distributed dividends, gross
-
-
-
(697)
(697)
Dividends received, treasury shares
-
-
-
3
3
Buyback of treasury shares
-
-
-
(43)
(43)
Incentive programs
-
-
-
7
7
Tax on other transactions in equity
-
-
-
1
1
Other transactions
-
-
-
(729)
(729)
Equity at 31 March 2024
996
1,314
(29)
20,154
22,435
DKK million
Share
capital
Foreign
currency
translation
reserve
Hedging
reserve
Retained
earnings
Total
equity
Equity at 1 January 2023
996
1,438
156
18,189
20,779
Profit for the period
-
-
-
880
880
Other comprehensive income
-
(157)
89
-
(68)
Comprehensive income
-
(157)
89
880
812
Distribution of dividends, gross
-
-
-
(578)
(578)
Dividends received, treasury shares
-
-
-
2
2
Buyback of treasury shares
-
-
-
(43)
(43)
Incentive programs
-
-
-
8
8
Other transactions
-
-
-
(611)
(611)
Equity at 31 March 2023
996
1,281
245
18,458
20,980
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 22
Corporate Release No 757/2024
CONDENSED STATEMENT OF CASH FLOWS
DKK million
Q1 2024
Q1 2023
Profit from operations (EBIT)
1,278
1,233
Adjustments for non-cash items
645
623
Change in working capital
(886)
(1,361)
Cash flows from operations before financial receipts and payments
1,037
495
Financial receipts and payments
32
(51)
Cash flows from ordinary activities
1,069
444
Income taxes paid
(108)
(66)
Cash flows from operating activities
961
378
Purchase and sale of intangible assets and property, plant and equipment
(94)
(77)
Cash flows from investing activities
(94)
(77)
Cash flows from operating and investing activities
(free cash flow)
867
301
Repayment of bank loans and borrowings
-
(314)
Dividends paid in the financial year, net
(694)
(576)
Other financing activities
(66)
(65)
Cash flows from financing activities
(760)
(955)
Net cash flow for the period
107
(654)
Cash and cash equivalents at beginning of period
5,010
3,548
Unrealized exchange gains/losses on cash and cash equivalents
(4)
(12)
Net cash flow for the period
107
(654)
Cash and cash equivalent at end of period
5,113
2,882
Interest-bearing debt, cash, cash equivalents and securities, net, is
composed as follows:
Cash and cash equivalents
5,113
2,882
Interest-bearing debt
(4,314)
(5,373)
Net cash/(net debt)
799
(2,491)
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 23
Corporate Release No 757/2024
STATEMENT OF PROFIT OR LOSS – ADJUSTED EBITDA RECONCILIATION (Q1)
Q1 2024
Q1 2023
DKK million
Reported
Adjusted
Reported
Adjusted
Revenue
5,288
5,288
5,044
5,044
Cost of sales
1,009
588
1,041
476
Gross profit
4,279
4,700
4,003
4,568
Sales and distribution costs
1,789
1,767
1,673
1,649
Administrative expenses
259
254
258
253
Research and development costs
953
933
839
821
Profit from operations (EBIT)
1,278
-
1,233
-
Depreciation/amortization
468
-
511
-
EBITDA
1,746
1,746
1,744
1,845
EBITDA margin
33.0%
33.0%
34.6%
36.6%
Adjustments to EBITDA
Integration costs
-
-
-
-
Restructuring expenses
-
-
-
-
Gains/losses on divestment of businesses
-
-
-
-
Acquisition expenses
-
-
-
-
Other adjustments
-
-
101
-
Adjusted EBITDA
1,746
1,746
1,845
1,845
Adjusted EBITDA margin
33.0%
33.0%
36.6%
36.6%
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 24
Corporate Release No 757/2024
4 NOTES
4.1 BASIS OF PREPARATION
The interim condensed consolidated financial statements for the three months ended 31 March 2024, 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 31 December 2023,
published 7 February 2024. The accounting policies, judgements and significant estimates are consistent with those
applied in the Annual Report 2023.
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
2.10 General corporate matters.
A number of new amendments came into effect from 1 January 2024. 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
31 March 2024
Level 1
Level 2
Level 3
Financial assets
Other financial assets
1
32
-
28
Derivatives
1
-
33
33
Total
32
33
61
Financial liabilities
Contingent consideration
1
-
-
355
Derivatives
1
-
100
-
Bond debt²
3,371
-
-
Total
3,371
100
355
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 2024 and going forward, Lundbeck will focus on revenue and adjusted EBITDA at
constant exchange rates (CER), instead of revenue and adjusted EBITDA at reported rates, to provide a more
focused view of the underlying operational performance.
FINANCIAL REPORT FOR THE PERIOD 1 JANUARY TO 31 MARCH 2024 Page 25
Corporate Release No 757/2024
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
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 1 JANUARY TO 31 MARCH 2024 Page 26
Corporate Release No 757/2024
FINANCIAL CALENDAR 2024
21 August 2024: Financial statements for the first six months of 2024
13 November 2024: Financial statements for the first nine months of 2024
5 February 2025: Corporate release for the full year 2024
5 February 2025: Annual Report 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
About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of
experience in improving the lives of people with neurological and psychiatric diseases.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex
challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.
Our goal is to create long term value and make a positive contribution to people and societies, everywhere we
operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people
we serve and the communities we are part of.
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, 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.
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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