XCSE:HLUN-B ESEF Annual Report
H. LUNDBECK A/S (XCSE:HLUN-B)
ESEF Annual Report
2024-11-26
For: 2024-09-30
View Original
Added on
September 22, 2026
CORPORATE RELEASE
NOVEMBER 13, 2024
Corporate Release No 763/2024
Phone: +45 363 0 1311
Copenhagen
CVR-no.: 5675991 3
Page 1
Financial report for the period January 1 to September 30, 2024
Accelerated growth for strategic brands (+21% CER) drives
revenue up 13% CER in the first nine months of 2024
Key highlights
Lundbeck’s total revenue grew by +13% CER
1
(+10% DKK) to DKK 16,463 million in the first nine months of 2024, with
all regions contributing to growth
• United States: DKK 8,342 million (+14% CER; +14% DKK)
• Europe: DKK 3,815 million (+12% CER; +10% DKK)
• International Operations: DKK 4,062 million (+9% CER; +3% DKK)
The revenue of Lundbeck’s strategic brands increased by +21% CER (+20% DKK), reaching DKK 12,116 million,
representing 74% of total revenue and with all four products showing double-digit growth rates both CER and reported
• Rexulti®: DKK 3,806 million (+16% CER; +15% DKK)
• Brintellix®/Trintellix®: DKK 3,576 million (+14% CER; +12% DKK)
• Abilify LAI franchise
2
: DKK 2,618 million (+10% CER; +10% DKK)
• Vyepti®: DKK 2,116 million (+76% CER; +76% DKK)
Adjusted EBITDA
3
increased to DKK 5,196 million (+12% CER; +7% DKK) reflecting the strong revenue growth across all
strategic brands. Adjusted EBITDA margin (DKK) reached 31.6% equivalent to a decrease of 0.9 percentage points due
to higher raw material and manufacturing costs and increased R&D investments in the maturing pipeline. Furthermore,
unfavorable net currency and hedging effects of DKK 185 million, negatively impacting the adjusted EBITDA margin by
0.6 percentage points. EBITDA increased to DKK 4,495 million (+6% CER; +1% DKK), impacted by an impairment loss
from a negative read-out of one of the MAGLi projects affecting R&D costs, while the first nine months of 2023 included
a provision for Vyepti obsolescence.
Lundbeck has raised the lower end of its full year guidance range, and the revenue growth is now expected to be 12%
to 14% at CER, previously 11% to 14% at CER, when compared to revenue of the prior year excluding the effect from
hedging. The Adjusted EBITDA growth is now expected to be 17% to 20% at CER, previously 15% to 20% at CER, when
compared to adjusted EBITDA of the prior year excluding effects from hedging.
Lundbeck’s President and CEO, Charl van Zyl said:
“I am pleased with our strong performance throughout the first nine months of 2024, which during the third quarter was
further bolstered by accelerating growth of our strategic brands including Vyepti® and Rexulti®. The expected
acquisition of Longboard Pharmaceuticals and its lead asset bexicaserin will complement the promising developments
in our internal pipeline, enabling us to take decisive steps towards the establishment of the neuro-rare franchise that
will be a cornerstone in the realization of our Focused Innovator strategy.”
Key figures
1
Change at CER (Constant Exchange Rates) does not include effects from hedging.
2
Abilify long-acting injectable (LAI) franchise comprises following products: Abilify Maintena®, Abilify Maintena® 960 mg and Abilify Asimtufii®
3
EBITDA refers to Earnings Before Interest, Taxes, Depreciation and Amortization, including impairment losses. Adjusted EBITDA is defined as EBITDA adjusted by certain items,
for details see section 4 Notes, note 4 Adjusted EBITDA.
DKK million
9M 2024
9M 2023
Change
(CER)
1
Change
(DKK)
Q3 2024
Q3 2023
Change
(CER)
1
Change
(DKK)
Revenue
16,463
14,934
13%
10%
5,722
4,952
18%
16%
EBITDA
4,495
4,463
6%
1%
1,278
1,385
(2%)
(8%)
Adjusted EBITDA
5,196
4,859
12%
7%
1,831
1,521
26%
20%
EPS (DKK)
2.57
2.17
18%
0.78
0.68
15%
Adjusted EPS (DKK)
3.94
3.65
8%
1.30
1.17
11%
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 2
Recent events
On October 31, 2024, Lundbeck announced that Vyepti® (eptinezumab) met the primary and all key secondary
endpoints in SUNRISE, a phase III pivotal clinical trial predominantly conducted in Asia evaluating the efficacy and
safety in patients with chronic migraine. Based on the trial results Lundbeck plans to initiate discussions with relevant
regulatory authorities with the aim of making Vyepti available for people suffering from migraine across Asia.
On October 23, 2024, Lundbeck hosted a Capital Markets Event (CME) in Valby, Denmark where Lundbeck provided a
broad progress update on its Focused Innovator strategy.
On October 14, 2024, Lundbeck and Longboard Pharmaceuticals, Inc. (Longboard) announced an agreement for
Lundbeck to acquire 100% of the company, a publicly owned U.S. company based in La Jolla, California, listed on
Nasdaq. Under the terms of the agreement, Lundbeck will commence a tender offer for all outstanding shares of
Longboard common stock for USD 60.00 per share, to be paid in cash. The total consideration is valued at USD 2.5
billion (approximately DKK 17 billion), on a fully diluted basis, excluding the company’s cash holdings. The transaction
is expected to close in December 2024, subject to the tender of at least a majority of the total number of Longboard
outstanding voting shares, receipt of required regulatory clearances, and other customary conditions.
On October 3, 2024, Lundbeck announced taking one further step in developing treatments for indications in the
neuroimmunology and neuroinflammatory space with the initiation of the first clinical trial of its CD40L blocker, Lu
AG22515, in patients. Lundbeck’s proof-of-concept trial will evaluate the efficacy, safety, and tolerability of Lu
AG22515 as a potential treatment for Thyroid Eye Disease, an autoimmune disease causing a debilitating, disfiguring,
and potentially blinding periocular condition.
On September 27, 2024, Lundbeck announced data from the TALISMAN natural history study, as well as additional data
from the AMULET trial of amlenetug (Lu AF82422) in Multiple System Atrophy (MSA) at the International Congress of
Parkinson’s Disease and Movement disorders (MDS congress) in Philadelphia, USA.
On September 26, 2024, Lundbeck and Iambic Therapeutics, a clinical-stage biotechnology company developing novel
therapeutics using its unique AI-driven discovery platform, announced that the companies have entered a strategic
research collaboration to focus on discovery of a small molecule therapeutic for the treatment of migraine.
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, 2024
Corporate Release No 763/2024
Page 3
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 .................................................................................................... 11
2.7 Summary of key developments in the third quarter of 2024 ......................................................... 12
2.8 Outlook ................................................................................................................................... 13
2.9 Lundbeck’s development portfolio ............................................................................................ 16
2.10 Sustainability update .............................................................................................................. 18
2.11 General corporate matters ...................................................................................................... 20
3 Condensed financial statements ............................................................................................... 23
4 Notes ....................................................................................................................................... 28
Financial calendar 2025 ............................................................................................................... 30
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 4
1 FINANCIAL HIGHLIGHTS
For the nine months ended September 30
DKK million
9M 2024
9M 2023
Change
(CER)
1
Change
(DKK)
Revenue
16,463
14,934
13%
10%
Gross profit
13,304
11,657
17%
14%
Gross margin
80.8%
78.1%
Adjusted gross profit
2
14,563
13,343
11%
9%
Adjusted gross margin
88.5%
89.3%
Sales and distribution costs
5,746
5,297
10%
8%
S&D ratio
34.9%
35.5%
Administrative expenses
1,080
915
19%
18%
Administrative expenses ratio
6.6%
6.1%
Research and development costs
3,385
2,481
36%
36%
R&D ratio
20.6%
16.6%
EBIT (profit from operations)
3,093
2,964
12%
4%
EBIT margin
18.8%
19.8%
EBITDA
3
4,495
4,463
6%
1%
EBITDA margin
27.3%
29.9%
Adjusted EBITDA
4
5,196
4,859
12%
7%
Adjusted EBITDA margin
31.6%
32.5%
Net financials, (income)/expenses
54
146
-
(63%)
Profit before tax
3,039
2,818
-
8%
Income taxes
486
662
-
(27%)
Effective tax rate (reported)
16.0%
23.5%
Net profit
2,553
2,156
-
18%
Adjusted net profit
5
3,911
3,620
-
8%
Other key numbers
Assets
39,516
37,672
-
5%
Equity
23,836
22,305
-
7%
Cash flows from operating and investing activities
(free cash flow)
4,134
2,777
-
49%
Net cash flow for the period
3,326
713
-
366%
Return on invested capital – rolling four quarters
13.1%
11.1%
Net debt/EBITDA – rolling four quarters
(0.8)
0.0
-
-
Number of shares for the calculation of EPS (millions)
991.5
992.3
-
0%
Earnings per share, basic (EPS) (DKK)
2.57
2.17
-
18%
Adjusted earnings per share, basic (DKK)
3.94
3.65
-
8%
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, including impairment losses.
4
Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see section 4 Notes, note 4 Adjusted EBITDA.
5
Adjusted net profit is the net profit excluding depreciation and amortization and other adjustments, net of taxes.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 5
2 BUSINESS PERFORMANCE
2.1 REVENUE BY PRODUCT
Revenue reached DKK 16,463 million representing a
growth of +13% CER (+10% DKK). All regions
contributed to the strong growth in strategic brands of
+21% CER (+20% DKK) reaching DKK 12,116 million,
equivalent to 74% of total revenue. Approximately 70%
of the strategic brand growth can be attributed to the
strong performance of Vyepti
®
, growing +66% CER
(+66% DKK) and accelerated growth of Rexulti
®
with
+14% CER (+14% DKK) both in the U.S. based on
overall demand and market share gains. Vyepti has
also shown exceptional growth in Europe at +245%
CER (+245% DKK) as well as in the International
Operations at +173% CER (+170% DKK), together
comprising 12% of the total revenue in the period from
Vyepti sales. The largest markets for the strategic
brands are the U.S., Canada, Spain, Italy and Australia.
DKK million
9M 2024
9M 2023
Growth
(CER)
Growth
(DKK)
Q3 2024
Q3 2023
Growth
(CER)
Growth
(DKK)
Rexulti
®
3,806
3,309
16%
15%
1,425
1,174
22%
21%
Brintellix
®
/Trintellix
®
3,576
3,207
14%
12%
1,225
1,051
19%
17%
Abilify LAI franchise
2,618
2,374
10%
10%
893
790
13%
13%
Vyepti
®
2,116
1,201
76%
76%
774
444
74%
74%
Strategic brands
12,116
10,091
21%
20%
4,317
3,459
25%
25%
Cipralex
®
/Lexapro
®
1,627
1,701
2%
(4%)
511
501
7%
2%
Other pharmaceuticals
2,476
2,905
(13%)
(15%)
772
881
(11%)
(12%)
Mature brands
4,103
4,606
(7%)
(11%)
1,283
1,382
(5%)
(7%)
Other revenue
287
193
48%
49%
130
61
113%
113%
Total revenue before hedging
16,506
14,890
13%
11%
5,730
4,902
18%
17%
Effects from hedging
(43)
44
(8)
50
Total revenue
16,463
14,934
13%
10%
5,722
4,952
18%
16%
Strategic brands
Rexulti
®
(brexpiprazole) revenue reached DKK 3,806
million representing a growth of +16% CER (+15%
DKK). In the U.S., revenue growth was driven by robust
underlying demand growth in MDD partially attributed
to the continued Direct-to-consumer (DTC) campaign
re-launched at the end of February 2024 and continued
strong long-term care segment uptake in AADAD which
now constitutes approximately 13% of sales in the U.S.
In Europe and International Operations, sales growth
was primarily driven by increased demand and market
share gains in countries such as Canada and Brazil.
The revenue distribution by region was 92%, 2% and
6% in the U.S., Europe and International Operations,
respectively. The largest markets are the U.S., Brazil,
Canada, Australia and Mexico. Rexulti
®
is approved as
an adjunctive therapy for the treatment of adults with
major depressive disorder (MDD) and for the treatment
of adults with schizophrenia as well as agitation
associated with dementia due to Alzheimer’s Disease
(AADAD) in the U.S. Rexulti
®
is approved as an
adjunctive therapy for the treatment of adults with
MDD and schizophrenia in Brazil and Canada. In
Canada, the product is additionally approved for the
treatment of agitation associated with Alzheimer’s
Dementia. Moreover, Rexulti
®
is approved for
schizophrenia in Australia and Europe.
Brintellix
®
/Trintellix
®
(vortioxetine) revenue reached
DKK 3,576 million representing a growth of +14% CER
(+12% DKK), contributed by all regions, with strong
performance primarily in Europe and International
Operations, mainly driven by continued higher
demand in markets such as Spain, Italy and Japan,
while the U.S. executes on strategy by transitioning
sales operation to Takeda as part of the agreement
signed in July 2024. The revenue distribution by region
was 32%, 36% and 32% in the U.S., Europe and
International Operations, respectively. The largest
markets for the product are the U.S., Spain, Canada,
Italy and Brazil. Brintellix
®
/Trintellix
®
is approved for the
treatment of MDD.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 6
Abilify LAI franchise revenue reached DKK 2,618
million representing a growth of +10% CER (+10% DKK)
contributed by all regions. In the U.S., sales growth
was primarily driven by a combination of continued
higher demand and price increase as well as the
continued growth due to increasing conversions to
Abilify Asimtufii
®
from oral aripiprazole. In Europe,
sales growth was driven by higher demand with solid
contribution from Spain, France, Belgium and
Portugal. The continued demand uptake in Canada
and Australia also contributed strongly to International
Operations sales growth. The revenue distribution by
region was 38%, 45% and 17% in the U.S., Europe and
International Operations, respectively. The largest
markets are the U.S., Spain, Canada, Australia and
Italy. Abilify Maintena
®
(aripiprazole) is approved for
the treatment of schizophrenia in Europe and for both
schizophrenia and bipolar I disorder as a once-
monthly injection in the U.S., Canada and Australia. In
April 2023, FDA approved aripiprazole as an every-two-
months injection branded as Abilify Asimtufii
®
which
was launched in the U.S. in June 2023. In March 2024,
the European Commission approved Abilify
Maintena
®
960 mg (aripiprazole) as a once-every-two-
months long-acting injectable formulation for the
maintenance treatment of schizophrenia in adult
patients stabilized with aripiprazole. This applies to all
European Union members as well as Iceland, Norway
and Liechtenstein.
Vyepti
®
(eptinezumab) continued to deliver strong
growth in the first nine months of 2024 and revenue
reached DKK 2,116 million following an increase of
+76% CER (+76% DKK) across all regions. Vyepti
®
sales
growth was mainly driven by continued demand
uptake with strong performance in the U.S., France
and Canada, followed by launches across the world. In
the U.S., Vyepti
®
had 9.4% of the prevention market by
late September, which constitutes all-time high
market share. The revenue distribution by region was
88%, 8% and 4% in the U.S., Europe and International
Operations, respectively. Vyepti
®
is approved as a
preventive treatment of migraine in adults and has
established a global presence since its initial U.S.
launch in April 2020. Vyepti
®
has been launched in
approximately 30 markets worldwide.
Mature brands
Cipralex
®
/Lexapro
®
(escitalopram) revenue reached
DKK 1,627 million representing a growth of +2% CER
(-4% DKK) mainly due to demand growth in China and
price increases in Turkey and Argentina due to
inflation, partially offset by continued erosion in Japan
and Switzerland. The revenue distribution by region
was 69% and 31% in International Operations and
Europe, respectively. The largest markets are China,
Brazil, Italy, South Korea and Saudi Arabia.
Cipralex
®
/Lexapro
®
is approved for the treatment of
MDD.
Revenue from Other pharmaceuticals, which
comprises the remainder of Lundbeck’s products,
reached DKK 2,476 million representing a decline of
-13% CER (-15% DKK), mainly due to the expected
lower sales of mature products such as Northera
®
,
Sabril
®
, Onfi
®
and Deanxit
®
. As of January 1, 2024,
Sabril
®
is being reported together with Other
pharmaceuticals, comparative figures for 2023 have
been restated accordingly. The largest markets for
Other pharmaceuticals are the U.S., China, France,
South Korea and U.K.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 7
2.2 REVENUE BY GEOGRAPHICAL AREA
DKK million
9M 2024
9M 2023
Growth
(CER)
Growth
(DKK)
Q3 2024
Q3 2023
Growth
(CER)
Growth
(DKK)
United States
Rexulti
®
3,512
3,074
14%
14%
1,323
1,094
20%
21%
Vyepti
®
1,858
1,119
66%
66%
678
415
62%
63%
Trintellix
®
1,134
1,057
8%
7%
407
362
12%
12%
Abilify LAI franchise
992
866
15%
15%
351
286
22%
23%
Strategic brands
7,496
6,116
23%
23%
2,759
2,157
27%
28%
Mature brands
846
1,201
(29%)
(30%)
276
373
(27%)
(26%)
Revenue – United States
8,342
7,317
14%
14%
3,035
2,530
19%
20%
Europe
Brintellix
®
1,282
1,106
17%
16%
435
361
21%
20%
Abilify LAI franchise
1,171
1,072
9%
9%
391
357
9%
10%
Vyepti
®
169
49
245%
245%
66
22
200%
200%
Rexulti
®
57
42
38%
36%
22
14
57%
57%
Strategic brands
2,679
2,269
19%
18%
914
754
21%
21%
Mature brands
1,136
1,185
0%
(4%)
384
367
7%
5%
Revenue – Europe
3,815
3,454
12%
10%
1,298
1,121
16%
16%
International Operations
Brintellix
®
/Trintellix
®
1,160
1,044
17%
11%
383
328
24%
17%
Abilify LAI franchise
455
436
5%
4%
151
147
3%
3%
Rexulti
®
237
193
34%
23%
80
66
38%
21%
Vyepti
®
89
33
173%
170%
30
7
343%
329%
Strategic brands
1,941
1,706
19%
14%
644
548
24%
18%
Mature brands
2,121
2,220
1%
(4%)
623
642
1%
(3%)
Revenue – International
Operations
4,062
3,926
9%
3%
1,267
1,190
12%
6%
Other revenue
287
193
48%
49%
130
61
113%
113%
Total revenue before hedging
16,506
14,890
13%
11%
5,730
4,902
18%
17%
Effects from hedging
(43)
44
(8)
50
Total revenue
16,463
14,934
13%
10%
5,722
4,952
18%
16%
Lundbeck’s largest markets are the U.S., China,
Canada, Spain and Italy constituting 69% of the total
revenue.
United States revenue reached DKK 8,342 million
representing a growth of +14% CER (+14% DKK). The
strategic brands reached DKK 7,496 million increasing
+23% CER (+23% DKK), representing 90% of the
revenue. The revenue growth is mainly driven by the
increasing market share as well as the continued
demand uptake of Rexulti
®
following the AADAD
approval and the strong performance of Vyepti
®
, offset
by erosion of mature brands such as Northera
®
, Onfi
®
and Sabril
®
.
Europe revenue reached DKK 3,815 million
representing a growth of +12% CER (+10% DKK). The
strategic brands reached DKK 2,679 million increasing
+19% CER (+18% DKK), representing 70% of revenue.
The revenue growth is mainly driven by higher demand
for Brintellix
®
and Abilify Maintena
®
as well as
continued strong performance of Vyepti
®
across the
region mainly in France and Spain. Mature brands have
been impacted by ongoing erosion of certain brands
such as Cipralex
®
in Switzerland, Cipramil
®
and
Cisordinol
®
. The largest markets in Europe are Spain,
Italy, France, Switzerland and U.K.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 8
International Operations comprises all Lundbeck’s
markets outside the U.S. and Europe. Revenue
reached DKK 4,062 million representing a growth of
+9% CER (+3% DKK). The strategic brands reached
DKK 1,941 million increasing by +19% CER (+14%
DKK), representing 48% of revenue. The revenue
growth is mainly driven by higher demand across all
four brands with solid contribution from the biggest
markets. Mature brands have been impacted by
ongoing erosion of certain brands such as Lexapro
®
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,
Australia and South Korea. China and Canada
constitute approximately 43% 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 43 million in the first nine months of
2024, compared to a positive impact of DKK 44 million
in the same period last year.
2.3 GROSS PROFIT
DKK million
9M 2024
9M 2023
Change
(CER)
Change
(DKK)
Q3 2024
Q3 2023
Change
(CER)
Change
(DKK)
Revenue
16,463
14,934
13%
10%
5,722
4,952
18%
16%
Cost of sales
3,159
3,277
(1%)
(4%)
1,094
1,098
1%
0%
thereof adjustments
(2)
327
101%
101%
-
67
-
-
thereof amortization of product rights
1,093
1,173
(7%)
(7%)
362
384
(6%)
(6%)
thereof depreciation/amortization
168
186
(10%)
(10%)
58
63
(8%)
(8%)
Gross profit
13,304
11,657
17%
14%
4,628
3,854
23%
20%
Gross margin (%)
80.8%
78.1%
80.9%
77.8%
Adjusted gross profit
14,563
13,343
11%
9%
5,048
4,368
18%
16%
Adjusted gross margin (%)
88.5%
89.3%
88.2%
88.2%
Cost of sales reached DKK 3,159 million, decreasing
by -1% CER (-4% DKK) mainly driven by lower
amortization due to fully amortized product rights of
one of our products and a favorable volume and mix
impact in the first nine months of 2024. Moreover,
adjustments of DKK 327 million were made in the first
nine months of 2023 to account for the impact of the
negative effect of Vyepti
®
inventory obsolescence of
DKK 312 million and restructuring costs of DKK 15
million due to the closure of the sterile manufacturing
line in France. Excluding the effect of those
extraordinary items in the first nine months of 2023,
cost of sales increased +10% CER (+7% DKK) primarily
driven by continued sales growth as well as higher raw
materials and manufacturing costs due to inflation,
offset by lower amortization costs as well as a
favorable volume and mix impact in the first nine
months of 2024.
Gross profit reached DKK 13,304 million, increasing
by +17% CER (+14% DKK). The gross margin was
80.8% representing an increase of 2.7 percentage
points. This increase was primarily driven by lower
amortization costs as well as a favorable volume and
mix impact, offset by higher raw material and
manufacturing costs in the first nine months of 2024.
Additionally, gross margin in the first nine months of
2023 was impacted by the negative effect of Vyepti
®
inventory obsolescence of DKK 312 million and
restructuring costs of DKK 15 million due to the closure
of the sterile manufacturing line in France, of which
DKK 2 million was reversed during the third quarter of
2024.
Adjusted gross profit is the gross profit excluding
depreciation and amortization and other adjustments
linked to sales and cost of sales. The adjusted gross
margin was 88.5% representing a decrease of 0.8
percentage points. This decrease is primarily driven by
higher raw material and manufacturing costs in the
first six months of 2024 due to inflation, partially offset
by a favorable volume and mix impact.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 9
2.4 EBIT AND ADJUSTED EBITDA
DKK million
9M 2024
9M 2023
Change
(CER)
Change
(DKK)
Q3 2024
Q3 2023
Change
(CER)
Change
(DKK)
Revenue
16,463
14,934
13%
10%
5,722
4,952
18%
16%
Gross profit
13,304
11,657
17%
14%
4,628
3,854
23%
20%
thereof adjustments
(2)
327
101%
101%
-
67
-
-
thereof depreciation/amortization
1,261
1,359
(7%)
(7%)
420
447
(6%)
(6%)
Sales and distribution costs
5,746
5,297
10%
8%
1,952
1,796
10%
9%
thereof adjustments
8
-
-
-
8
-
-
-
thereof depreciation/amortization
66
70
(3%)
(6%)
22
23
0%
(4%)
S&D ratio
34.9%
35.5%
34.1%
36.3%
Administrative expenses
1,080
915
19%
18%
342
351
(1%)
(3%)
thereof adjustments
148
69
114%
114%
(2)
69
(103%)
(103%)
thereof depreciation/amortization
15
16
(6%)
(6%)
5
6
(17%)
(17%)
Administrative expenses ratio
6.6%
6.1%
6.0%
7.1%
Research and development costs
3,385
2,481
36%
36%
1,523
816
86%
87%
thereof adjustments
547
-
-
-
547
-
-
-
thereof depreciation/amortization
60
54
11%
11%
20
18
11%
11%
R&D ratio
20.6%
16.6%
26.6%
16.5%
Total operating expenses
10,211
8,693
18%
17%
3,817
2,963
29%
29%
OPEX ratio
62.0%
58.2%
66.7%
59.8%
EBIT (profit from operations)
3,093
2,964
12%
4%
811
891
(1%)
(9%)
Depreciation/amortization
1,402
1,499
(6%)
(6%)
467
494
(5%)
(5%)
EBITDA
4,495
4,463
6%
1%
1,278
1,385
(2%)
(8%)
EBITDA margin (%)
27.3%
29.9%
22.3%
28.0%
Restructuring expenses
4
15
(73%)
(73%)
6
-
-
-
Other adjustments
697
381
83%
83%
547
136
302%
302%
Adjusted EBITDA
5,196
4,859
12%
7%
1,831
1,521
26%
20%
Adjusted EBITDA margin (%)
31.6%
32.5%
32.0%
30.7%
Total operating expenses (OPEX) reached DKK
10,211 million corresponding to an increase of +18%
CER (+17% DKK). The OPEX ratio reached 62.0%,
increasing by 3.8 percentage points. The increase of
OPEX is primarily driven by the effect of an impairment
loss of DKK 547 million due to a negative read-out of
one of the MAGLi projects as well as continued R&D
investments. The increase in the OPEX ratio was also
impacted by higher administrative expenses mainly
due to higher legal costs in the first nine months of
2024. Adjusted for the impairment loss of DKK 547
million as well as the legal provisions in 2023 and 2024,
OPEX increased +11% CER (+10% DKK).
Sales and distribution costs reached DKK 5,746
million corresponding to an increase of +10% CER
(+8% DKK) compared to revenue growth of +13%
(CER). The S&D ratio reached 34.9%, representing a
slight decrease of 0.6 percentage points. The
development reflects the strong revenue growth,
which offsets the continued investments in sales and
promotion activities in strategic brands such as
Rexulti
®
and Vyepti
®
in the U.S., including PTSD
preparation for Rexulti
®
pending FDA review and the
global roll-out of Vyepti
®
. Furthermore, sales and
distribution costs for the first nine months of 2024
were negatively impacted by the recognition of DKK 8
million for restructuring costs.
Administrative expenses reached DKK 1,080 million
increasing by +19% CER (+18% DKK). The
administrative expense ratio reached 6.6%, increasing
by 0.5 percentage points, primarily driven by higher
legal costs mainly due to DKK 150 million of legal
provisions for ongoing litigations recognized in the
second quarter of 2024.
Research and development costs reached DKK
3,385 million with an R&D ratio of 20.6% increasing
+36% CER (+36% DKK). Lundbeck recognized an
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 10
impairment loss on part of the carrying amount of one
of the MAGLi projects following a negative data read
out from a phase I project in the third quarter of 2024,
resulting in an impact of DKK 547 million. Adjusted for
the impairment loss of DKK 547 million, R&D costs
increased +14% CER (+14% DKK), mainly driven by the
progression of the phase IIb dose finding trial for Lu
AG09222 anti-PACAP, progress of phase III
preparations for amlenetug (anti-a-synuclein mAb) as
well as general higher discovery and development
costs across early-stage programs during the first nine
months of 2024, offset by lower Vyepti
®
phase IV trial
costs. Further details are available in section 2.9
Lundbeck’s development portfolio.
EBIT reached DKK 3,093 million, increasing by +12%
CER (+4% DKK) reflecting an improved gross profit
development driven by higher gross margin and lower
sales and distribution ratio, offset by increased R&D
costs due to continued pipeline investments as well as
the effect of the impairment loss due to the negative
MAGLi read-out, followed by higher administrative
expenses mainly related to DKK 150 million in legal
provisions due to ongoing litigations. Furthermore,
EBIT for the first nine months of 2023 was negatively
affected by the recognition of a provision of DKK 312
million for Vyepti
®
inventory obsolescence, DKK 69
million regarding legal provisions for ongoing
litigations and restructuring costs of DKK 15 million
due to the closure of the sterile manufacturing line in
France.
Amortization of product rights amounted to DKK
1,093 million corresponding to a decrease of -7% CER
(-7% DKK). Total amortization and depreciation
reached DKK 1,402 million representing a decrease of
-6% CER (-6% DKK) mainly driven by a decrease in the
amortization recognized in the first nine months of
2024 due to fully amortized product rights since the
beginning of 2024.
Adjusted EBITDA reached DKK 5,196 million
representing an increase of +12% CER (+7% DKK)
reflecting the strong revenue growth driven by
performance of strategic brands. The adjusted
EBITDA margin was 31.6% representing a decrease of
0.9 percentage points primarily due to increased cost
of sales driven by higher raw materials and
manufacturing costs due to inflation, higher R&D costs
and unfavorable net currency and hedging effects of
DKK 185 million, negatively impacting the adjusted
EBITDA margin by 0.6 percentage points, offset by
OPEX ratio improvements on the strong revenue
growth.
2.5 NET PROFIT AND ADJUSTED EPS
DKK million
9M 2024
9M 2023
Change
(DKK)
Q3 2024
Q3 2023
Change
(DKK)
EBIT (profit from operations)
3,093
2,964
4%
811
891
(9%)
Net financials, (income)/expenses
54
146
(63%)
79
8
888%
Profit before tax
3,039
2,818
8%
732
883
(17%)
Net profit
2,553
2,156
18%
777
676
15%
thereof other adjustments
701
396
77%
553
136
307%
thereof depreciation/amortization
1,402
1,499
(6%)
467
494
(5%)
thereof tax on adjustments
462
431
7%
224
143
57%
thereof tax adjustments
283
-
-
283
-
-
EPS (DKK)
2.57
2.17
18%
0.78
0.68
15%
Adjusted net profit
3,911
3,620
8%
1,290
1,163
11%
Adjusted EPS (DKK)
3.94
3.65
8%
1.30
1.17
11%
Net profit
Net financial (income)/expenses) amounted to an
expense of DKK 54 million equivalent to a decrease of
63% reflecting the positive development in interest
income due to underlying change in net debt/cash
position offset by unfavorable currency impact.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 11
The effective tax rate for the first nine months of 2024
was 16.0% (23.5% for the first nine months of 2023).
The tax rate is positively impacted by the reversal of an
uncertain tax position of DKK 283 million related to a
tax audit closed in the third quarter of 2024.
Net profit reached DKK 2,553 million corresponding to
a growth of 18%.
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 3,911
million, increasing +8%, reflecting the EBIT
development, offset by lower positive net financial
results.
Adjusted EPS was DKK 3.94 corresponding to an
increase of +8%.
2.6 CASH FLOW AND BALANCE SHEET
DKK million
9M 2024
9M 2023
Q3 2024
Q3 2023
Profit from operations (EBIT)
3,093
2,964
811
891
Cash flows from operating activities
4,480
3,139
2,302
1,490
Cash flows from investing activities
(346)
(362)
(101)
(97)
Cash flows from operating and investing activities
(free cash flow)
4,134
2,777
2,201
1,393
Cash flows from financing activities
(808)
(2,064)
(24)
(814)
Net cash flow for the period
3,326
713
2,177
579
Cash flows from operating activities amounted to an
inflow of DKK 4,480 million compared to an inflow of
DKK 3,139 million in the first nine months of 2023
mainly driven by a combination of a slightly higher
EBIT, lower inventory build-up due to the completion of
the fixed supply agreement for Vyepti
®
in September
2023 and short-term liabilities due to Rexulti
®
milestone paid-out in the first quarter of 2023, offset by
higher receivables.
Lundbeck’s net cash flows from investing activities
were an outflow of DKK 346 million compared to an
outflow of DKK 362 million in the first nine months 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 808 million compared to an
outflow of DKK 2,064 million in the first nine months of
2023 mainly related to the repayment of the revolving
credit facility in 2023 offset by higher dividend paid in
March 2024.
The net cash inflow reached DKK 3,326 million
compared to an inflow of DKK 713 million in the first
nine months of 2023.
Net debt has decreased from DKK 46 million at the end
of September 2023 to net cash of DKK 3,982 million at
the end of September 2024. Net debt/EBITDA ratio is
-0.8x at the end of September 2024 compared to 0.0x
at the end of September 2023. Interest-bearing debt
was DKK 4,340 million at the end of September 2024
compared to DKK 4,294 million at the end of
September 2023.
On September 30, 2024, Lundbeck’s total assets
amounted to DKK 39,516 million compared to DKK
37,407 million at the end of 2023.
On September 30, 2024, Lundbeck’s equity amounted
to DKK 23,836 million.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 12
2.7 SUMMARY OF KEY DEVELOPMENTS IN THE THIRD QUARTER OF 2024
For the quarter ended September 30
DKK million
Q3 2024
Q3 2023
Change
(CER)
1
Change
(DKK)
Revenue
5,722
4,952
18%
16%
Gross profit
4,628
3,854
23%
20%
Gross margin
80.9%
77.8%
Adjusted gross profit
2
5,048
4,368
18%
16%
Adjusted gross margin
88.2%
88.2%
Sales and distribution costs
1,952
1,796
10%
9%
S&D ratio
34.1%
36.3%
Administrative expenses
342
351
(1%)
(3%)
Administrative expenses ratio
6.0%
7.1%
Research and development costs
1,523
816
86%
87%
R&D ratio
26.6%
16.5%
EBIT (profit from operations)
811
891
(1%)
(9%)
EBIT margin
14.2%
18.0%
EBITDA
3
1,278
1,385
(2%)
(8%)
EBITDA margin
22.3%
28.0%
Adjusted EBITDA
4
1,831
1,521
26%
20%
Adjusted EBITDA margin
32.0%
30.7%
Net financials, expenses
79
8
-
888%
Profit before tax
732
883
-
(17%)
Income taxes
(45)
207
-
122%
Effective tax rate (reported)
(6.1%)
23.5%
Net profit
777
676
-
15%
Adjusted net profit
5
1,290
1,163
-
11%
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, including impairment losses.
4
Adjusted EBITDA is defined as EBITDA adjusted by certain items, for details see section 4 Notes, note 4 Adjusted EBITDA.
5
Adjusted net profit is the net profit excluding depreciation and amortization and other adjustments, net of taxes.
REVENUE
Revenue reached DKK 5,722 million representing a
growth of +18% CER (+16% DKK) in the third quarter of
2024. The increase in revenue is mainly driven by
strong performance across the strategic brands
reaching DKK 4,317 million, representing a growth of
+25% CER (+25% DKK), equivalent to 75% of total
revenue (see section 2.1) in the third quarter of 2024.
Approximately 68% of the strategic brand growth in the
third quarter of 2024 can be attributed to the strong
performance of Vyepti
®
growing +62% CER (+63%
DKK), as the continued investments in the brand
leading to sustained growth in market shares and
Rexulti
®
growing +20% CER (+21% DKK) both in the U.S.
due to uptake in long-term care AADAD segment and
continued uptake in MDD due to the successful Direct-
to-consumer campaign.
Moreover, Brintellix
®
/Trintellix
®
revenue grew by
contribution from all regions especially with a strong
performance in Europe and International Operations
driven by growth in market share leading to higher
demand, particularly in China, Spain and Japan.
Abilify LAI franchise revenue growth is driven by
higher demand in all regions, aided by the launch of
Abilify Asimtufii
®
, and favorable gross-to-net in the U.S.
Mature brands decreased -5% CER (-7% DKK) due to
the continued generic erosion.
GROSS PROFIT
Cost of sales decreased to DKK 1,094 million
increasing by +1% CER (0% DKK) mainly driven by
lower amortization due to fully amortized product
rights. Moreover, the third quarter of 2023 was
impacted by the negative effect of Vyepti
®
inventory
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 13
obsolescence of DKK 67 million. Excluding the effect
of this extraordinary item in the period, cost of sales
increased +8% CER (+6% DKK) primarily driven by the
sales growth.
In the third quarter of 2024, gross profit reached DKK
4,628 million increasing by +23% CER (+20% DKK).
The gross margin was 80.9% representing an increase
of 3.1 percentage points. Adjusted gross margin was
88.2% in the third quarter of 2024, in line with the same
period last year.
EBIT AND ADJUSTED EBITDA
Total operating expenses (OPEX) reached DKK 3,817
million corresponding to an increase of +29% CER
(+29% DKK). The OPEX ratio increased by 6.9
percentage points primarily driven by higher R&D costs
due to continued pipeline investments and the
impairment loss resulting from the effect of the
negative MAGLi read-out of DKK 547 million, offset by
lower sales and distribution costs as well as
administrative expenses.
Sales and distribution costs reached DKK 1,952
million corresponding to an increase of +10% CER
(+9% DKK). The S&D ratio was 34.1% in the third
quarter of 2024 representing a decrease of 2.2
percentage points.
Administrative expenses reached DKK 342 million
decreasing by -1% CER (-3% DKK). The administrative
expense ratio reached 6.0%, decreasing by 1.1
percentage points mainly driven by higher legal costs
in the third quarter of 2023 regarding legal provisions
for ongoing litigations.
Research and development costs reached DKK
1,523 million corresponding to an increase of +86%
CER (+87% DKK) with an R&D ratio of 26.6%. The
increase in R&D costs is mainly due to continued
pipeline investments as well as the impairment loss
resulting from the effect of the negative MAGLi read-
out of DKK 547 million.
EBIT reached DKK 811 million decreasing by -1% CER
(-9% DKK) reflecting an improved gross profit
development driven by higher gross margin and lower
sales and distribution and administrative costs ratio,
offset by increased R&D costs due to continued
pipeline investments as well as the impairment loss
resulting from the effect of the negative MAGLi read-
out.
Amortization of product rights amounted to DKK 362
million corresponding to a decrease of -6% CER (-6%
DKK). Total amortization and depreciation reached
DKK 467 million representing a decrease of -5% CER
(-5% DKK) mainly driven by lower product rights
amortization.
Adjusted EBITDA reached DKK 1,831 million
representing an increase of +26% CER (+20% DKK)
reflecting the strong revenue growth driven by
performance of strategic brands. The adjusted
EBITDA margin was 32.0% representing an increase of
1.3 percentage points mainly due to the OPEX ratio
favorability on the strong revenue growth, offset by
higher R&D costs as well as unfavorable net currency
and hedging effects of DKK 27 million, negatively
impacting the adjusted EBITDA margin by 0.7
percentage points.
NET PROFIT AND ADJUSTED EPS
Net financial (income)/expenses reached DKK 79
million equivalent to an increase of +888% and is
primarily driven by the change in currency impact.
The effective tax rate for the third quarter of 2024 was
-6.1%. The tax rate is positively impacted by the
reversal of an uncertain tax position of DKK 283 million
related to a tax audit closed in Q3 2024.
Net profit reached DKK 777 million corresponding to
an increase of +15%.
Adjusted net profit reached DKK 1,290 million,
representing an increase of +11%, reflecting the strong
performance across the strategic brands.
2.8 OUTLOOK
Financial guidance 2024
Lundbeck has raised the lower end of its full year
guidance range for 2024, where revenue is now
expected to grow 12% to 14% at CER, previously 11%
to 14% 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.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 14
The outlook for 2024 reflects the confidence in the
continuous high expectations for Rexulti
®
and Vyepti
®
volumes sold in the U.S. as well as higher
Brintellix
®
/Trintellix
®
demand in Europe and Asia.
Lundbeck’s expectations for adjusted EBITDA has
been raised in the lower end of its full year guidance.
Adjusted EBITDA is expected to grow 17% to 20% at
CER in 2024, previously 15% to 20% at CER, 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 now expected to be around 8
percentage points lower than at CER. Lundbeck
continues to expect increase in sales growth, partially
offset by higher investments in R&D and sales as well
as distribution due to increased Vyepti
®
and Rexulti
®
promotion activities, including PTSD preparation for
Rexulti
®
pending FDA review.
Lundbeck has also updated the other relevant
financial information related to its financial guidance
for 2024 to reflect the revised guidance. R&D costs
increased to DKK 4.4 to 4.6 billion to reflect the MAGLi
impairment loss of DKK 547 million recognized in the
third quarter of 2024. Lundbeck expects higher net
financial expenses between DKK -50 and -100 million
predominantly due to the depreciation of the USD in
the third quarter of 2024. The negative effects from
hedging are now expected between DKK -20 and -45
million compared to previously DKK -130 to -155
million. Furthermore, the effective tax rate has been
updated to reflect the positive impact of the reversal of
an uncertain tax position of DKK 283 million related to
a tax audit closed in the third quarter of 2024. Net cash
position is now projected to be a net debt position
between DKK 12 and 13 billion due to the foreseen
acquisition of Longboard.
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 (6.73);
CNY/DKK (0.95); CAD/DKK (5.09); BRL/DKK (1.30);
AUD/DKK (4.99).
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 guidance for 2024
Previous 2024 guidance
Revised 2024 guidance
Total revenue growth at CER
11% to 14%
12% to 14%
Adjusted EBITDA growth at CER
15% to 20%
17% to 20%
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 4.4 to 4.6 billion
Depreciation & amortization
DKK 1.8 to 2.0 billion
Net financials, (expenses)/gains
DKK -50 to -100 million
Effects from hedging, (losses)/gains
DKK -20 to -45 million
Effective tax rate
13% to 15%
Net cash/(net debt)
3
DKK -12 to -13 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 JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 15
Revenue at CER
DKK million
9M 2024
Total revenue (IFRS)
16,463
Effects from hedging
(43)
Total revenue (IFRS) before hedging
16,506
Effects from exchange rate
(283)
Total revenue at CER
16,789
Increase/(decrease) in total revenue
10%
Increase/(decrease) in total revenue at CER
1
13%
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
9M 2024
Adjusted EBITDA
5,196
Effects from hedging
(43)
Adjusted EBITDA before hedging
5,239
Effects from exchange rate
(142)
Adjusted EBITDA at CER
5,381
Increase/(decrease) in adjusted EBITDA
7%
Increase/(decrease) in adjusted EBITDA at CER
1
12%
1
Adjusted EBITDA at CER for the period divided by adjusted EBITDA before hedging for the comparative period.
Mid-term targets
As part of the company’s Capital Market Event on
October 23, 2024, Lundbeck adjusted its mid-term
financial targets by extending the period by one year to
include 2027 (compared to previously ending in 2026).
Based on organic growth, the company expects
revenue to show a mid-single digit compound annual
growth rate (CAGR) over the mid-term period (2023 to
2027). The company revised its targeted adjusted
EBITDA-margin from previously 30%-32% to now more
than 30% at the end of the mid-term period in 2027, to
account for the expected impact of the Longboard
acquisition and excluding any business development
activities.
Lundbeck plans to ensure appropriate investments in
R&D and prelaunch activities for bexicaserin following
the expected successful closure of the Longboard
acquisition. Moreover, in accordance with the
Focused Innovator strategy, Lundbeck has initiated its
most significant capital reallocation program in its
history to sustain the company’s growth with
increased focus on innovation.
Forward-looking statements
Forward-looking statements are subject to risks,
uncertainties, and inaccurate assumptions. This may
cause actual results to differ materially from
expectations. Various factors may affect future
results, including interest rates and exchange rate
fluctuations, delay or failure of development projects,
production problems, unexpected contract breaches
or terminations, governance-mandated or market-
driven price decreases for products, introduction of
competing products, Lundbeck’s ability to
successfully market both new and existing products,
exposure to product liability and other lawsuits,
changes in reimbursement rules and governmental
laws, and unexpected growth in expenses.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 16
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. Two phase Ib trials are currently ongoing in Congenital Adrenal Hyperplasia and
Cushing’s Disease. For technical reasons, the latter has been officially categorized as a Phase II trial to adhere to local requirements in Georgia.
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”).
8
Ph1b trial ongoing in TED (Thyroid Eye Disease).
Hormonal / neuropeptide signaling
Lu AG09222 – phase II
Lu AG09222 represents a potential new therapeutic
option for the treatment of migraine, which, unlike the
calcitonin gene-related peptide (CGRP) migraine
treatment drug class, is a monoclonal antibody
targeting pituitary adenylate cyclase-activating
polypeptide (PACAP). PACAP and its receptors are
broadly expressed in the nervous systems and
inflammatory cells. By interfering with the PACAP
signaling 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 enroll
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.
Lu AG13909 – Phase I/II
Lu AG13909 is a first-in-class monoclonal antibody,
which has the potential to offer a treatment alternative
to patients suffering from conditions related to the
hypothalamic-pituitary-adrenal (HPA) axis, leading to
increased levels of ACTH, adrenocorticotropic
hormone. By binding to ACTH with high affinity Lu
AG13909B aims to reduce elevated ACTH levels
potentially providing therapeutic benefits for
individuals with neurohormonal dysfunctions.
Lundbeck has initiated a first-in-human trial in patients
with Congenital Adrenal Hyperplasia (CAH) in
December 2022, and a trial in Cushing’s disease (CD)
in June 2024.
Circuitry / neuronal biology
Brexpiprazole in Post-Traumatic Stress Disorder
(PTSD)
On June 25, 2024, Lundbeck announced that a
supplemental new drug application (sNDA) for
brexpiprazole in combination with sertraline for the
treatment of adults with post-traumatic stress
disorder (PTSD) was accepted and filed by the FDA,
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
PROCEED
Lu AG13909 (anti-ACTH mAb)
5
Neuro-hormonal dysfunctions
Circuitry / neuronal biology:
Brexpiprazole
6
PTSD
MAGLi program
7
Neurology
Lu AF28996 (D
1
/D
2
agonist)
Parkinson’s disease
Protein aggregation, folding and clearance:
Amlenetug (anti-α-synuclein mAb)
Multiple system atrophy
AMULET
Neuroinflammation / neuroimmunology:
Lu AG22515 (anti-CD40L blocker)
8
Neurology
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 17
with a target date (PDUFA date) for completion of the
review of February 8, 2025.
The sNDA is based on data from three randomized
clinical trials evaluating the safety and efficacy of
brexpiprazole in combination with sertraline in adult
patients with PTSD, namely the phase II trial 061 and
the two phase III trials 071 and 072.
The primary endpoint for all three trials was the change
from week 1 to week 10 in the Clinician-Administered
PTSD Scale (CAPS-5) total score for brexpiprazole and
sertraline combination therapy versus sertraline plus
placebo in patients diagnosed with PTSD according to
the Diagnostic and Statistical Manual of Mental
Disorders, Fifth Edition (DSM-5).
The trials were randomized, double blind, active-
controlled, and Trial 061 and 071 were flexible-dose
trials, while Trial 072 was a fixed-dose trial. In Trial 061
and 071, brexpiprazole in combination with sertraline
was associated with a statistically significant
reduction (p<0.05) in PTSD symptoms compared to
sertraline plus placebo, as measured by the change in
the CAPS-5 total score from week 1 to week 10
(primary endpoint). In Trial 072, while the primary
endpoint was not met, reductions in PTSD symptom
severity with brexpiprazole in combination with
sertraline were consistent with Trials 061 and 071.
Across the three randomized trials, the combination of
brexpiprazole and sertraline in adult patients with
PTSD were generally well-tolerated, and no new safety
observations were identified.
Brexpiprazole – phase III in adolescent patients (13-
17 years old) with schizophrenia
A Type II variation to apply for pediatric schizophrenia
indication (for adolescents aged 13 to 17 years old)
was successfully submitted to European Medicines
Agency (EMA) on June 26, 2024. The expected action
date is in Q2 2025.
The submission is based on the phase III trial 331-10-
234 in adolescent patients with schizophrenia
(NCT03198078) which demonstrated a significant
improvement for brexpiprazole compared to placebo.
In the trial, brexpiprazole was generally well tolerated,
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).
Aripiprazole – two-month long-acting injectable
(LAI) formulation
The new two-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.
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. In July 2023, Lundbeck received a drug
product data-related Notice of Deficiency (NOD) from
Health Canada. The NOD response was submitted by
Lundbeck in Q1 2024 with anticipated
Review/Issuance of Notice of Compliance (NOC) by
Q1 2025.
Based on PK modelling, two supplemental New Drug
Applications (sNDA) to update the Abilify Asimtufii
®
and Abilify Maintena
®
USPIs with a 1-day initiation
regimen (1-IR) in addition to the currently approved
initiation regimens, was accepted and filed by the FDA
in August, 2024 with a target date (PDUFA date) for
completion of the review of March 30, 2025 for both
products. If approved, patients stabilized on oral
Abilify will be able to initiate the every-two-months
Abilify Asimtufii
®
treatment regimen in a single day by
administering one injection of Abilify Maintena
®
960
mg, one injection of Abilify Maintena 400 mg and a
single oral dose of aripiprazole 20 mg. For Abilify
Maintena
®
, the 1-IR consists of two separate injections
of Abilify Maintena 400 mg and a single oral dose of
aripiprazole 20 mg.
MAGLi program – phase I
Following a recent completion of a mechanism of
action phase I trial with Lu AG06474, emanating from
the acquisition of Abide Therapeutics, Inc., it has been
decided to write down part of the carrying amount of
this asset in the financial report for the first nine
months of 2024. There is still significant potential value
remaining from this acquisition, including an
additional ongoing program and a unique discovery
platform.
Vortioxetine – Pediatric development program in
MDD in Japan
Given a large unmet medical need and no medicines
approved in Japan for treatment of MDD in children,
Lundbeck has decided to initiate a pediatric
development program in collaboration with alliance
partner Takeda.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 18
The phase III trial is a randomized double-blind,
placebo-controlled 10-weeks study evaluating
efficacy and safety of flexible dose vortioxetine (10-
20mg) in MDD in adolescents 12-17 years old with
First-Patient-First-Visit planned for Q4 2025.
In August, 2024, based on the development program,
Lundbeck and Takeda received positive opinion from
the Pharmaceutical Affairs Council Committee on
Drug I (Bukai) of MHLW (Ministry of Health, Labour and
Welfare), that vortioxetine was granted a two-year
extension until 2029 of the re-examination period for
the adult indication in MDD, meaning that vortioxetine
LoE in Japan will be extended by two years. This
extension is unrelated to the phase III trial outcome.
Protein aggregation, folding and clearance
amlenetug (Lu AF82422) – phase II
Amlenetug 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 amlenetug 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 amlenetug 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 amlenetug compared to the placebo
group, and additional signals of efficacy were
observed across other clinical and biomarker
endpoints. Amlenetug was generally well tolerated.
Lundbeck plans to initiate a phase III study around
year-end 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. In April 2024, Lundbeck also
obtained orphan drug designation for the amlenetug in
MSA by the FDA.
Neuroimmunology/Neuroinflammation
Lu AG22515 – Phase Ib
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. Furthermore, Lu AG22515 is a promising
therapeutic candidate being developed under a
licensing and collaboration agreement between
Lundbeck and AprilBio Co., Ltd. It is a differentiated
anti-CD40L blocker fusion-protein, which exhibits high
potency, an extended half-life due to its SAFA
technology, and an improved safety profile. By
targeting the CD40L pathway, which is involved in the
activation of complex T-cell mediated autoimmune
responses, Lu AG22515 represents a novel approach
in the treatment landscape of TED and has potential in
a range of neuro-immunological diseases.
Lundbeck has initiated a phase IB trial to assess the
efficacy, safety, and tolerability of Lu AG22515 as a
potential treatment for Thyroid Eye Disease, an
autoimmune disease causing a debilitating,
disfiguring, and potentially blinding periocular
condition. The phase IB trial is planned to enroll 19
patients.
2.10 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 where we operate.
In this sustainability update, progress is presented for
Environmental, Social and Governance matters
supported by key performance metrics.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 19
ENVIRONMENTAL PERFORMANCE
Category
1
9M 2024
9M 2023
2
Change (%)
Scope 1 GHG emissions (Tonne CO₂ₑ)
16,432
15,944
3%
Scope 2 GHG emissions (Market Based) (Tonne CO₂ₑ)
3,204
2,889
11%
Scope 1+2 GHG emissions (Tonne CO₂ₑ)
19,636
18,833
4%
Energy consumption (MWh)
79,629
78,324
2%
1
See Lundbeck Sustainability Report 2023 for accounting policies and definitions.
2
All comparative figures were updated to reflect changes in estimates.
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 net-zero targets to reduce its total carbon footprint
across its own operations, supply chain, and
distribution.
In the first nine months of 2024, Scope 1 + 2 GHG
emissions increased by 4%, compared to the first nine
months of 2023. Scope 1 increased by 3%, mainly due
to an increase in emissions from the U.S. car fleet,
offset by a reduction in emissions from the production
sites. Scope 2 emissions increased by 11% primarily
due to the commencement of operation of a new
production unit at the production site in Padova (Italy).
Despite the increased emissions in the first nine
months of 2024, Lundbeck remains on track to meet its
climate targets for Scope 1 + 2 GHG emissions, 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 and recurring dialogue with the
Danish Environmental Protection Agency (EPA) and
local authorities regarding the mapping and
remediation possibilities of the pollution. Lundbeck
continues this close dialogue with the authorities and
affected stakeholders and is also conducting
additional testing to determine more precisely the
extent of the pollution.
Lundbeck has received orders from the EPA requiring
the installation of a pump and treat solution for subsoil
water. The implementation work has been initiated,
and it is estimated that the pump and treat solution will
be operational in the second half of 2025.
SOCIAL PERFORMANCE
Category
1
9M 2024
9M 2023
Change
2
Gender balance (women % in senior management)
35.7%
36.4%
(0.7)
1
See Lundbeck Sustainability Report 2023 for accounting policies and definitions.
2
Variation in percentage points.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 20
GOVERNANCE PERFORMANCE
Category
1
9M 2024
9M 2023
Change (%)
Due Diligence screenings of Suppliers and Third Parties (Number)
198
150
32%
1
See Lundbeck Sustainability Report 2023 for accounting policies and definitions.
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 nine months of 2024 increased by 32%,
compared to the first nine months of 2023. This
increase is due to continued growing awareness
across the organization on the importance of ethical
business conduct in the value chain.
2.11 GENERAL CORPORATE MATTERS
Pending legal proceedings
Lundbeck is involved in several 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 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
defense in the third quarter of 2023. The hearing on
whether the claim is time-barred was held in the
second quarter of 2024 and the Competition Appeal
Tribunal has subsequently issued a decision in favor of
the UK health authorities. Lundbeck has been granted
permission to appeal the decision to the Court of
Appeal and the substantive proceedings have been
stayed pending appeal.
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 was held in the second
quarter of 2024, and Lundbeck currently expects that
additional procedural steps will be taken before a first
instance court ruling, likely in the first half of 2025. The
first instance court ruling may be appealed, and it may
take several years before a final conclusion is reached
by the German courts.
In October 2024, Lundbeck received a claim form from
the health authority in one of the regions
(comunidades autónomas) in Spain and in November
2024 Lundbeck filed its defense.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 21
Lundbeck has been informed about potential claims in
several other European countries, however, it is still
uncertain whether the potential claims will be actively
pursued.
In Canada, Lundbeck is involved in two product liability
class-action lawsuits relating to Cipralex
®
/Celexa
®
(one case alleging various Celexa-induced birth
defects and one case against several SSRI
manufacturers (incl. Lundbeck) alleging that SSRI
(Celexa
®
/Lexapro
®
) induces autism birth defect), three
relating to Abilify Maintena
®
(alleging i.a. failure to warn
about compulsive behavior side effects) and one
relating to Rexulti
®
(also alleging i.a. failure to warn
about compulsive behavior side effects). 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’s
case against the last of the four generic companies,
Sandoz Pty Ltd, went up to the High Court of Australia,
who has decided that Sandoz Pty Ltd infringed
Lundbeck’s escitalopram patent between 2009 and
2012. The High Court has 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. Lundbeck’s appeal of the
Australian Patent Office’s decision to grant Sandoz a
license has now been decided, and the license was
substantially limited. Sandoz can still appeal the
license decision to the Federal 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.
Otsuka and Lundbeck have received paragraph IV
certifications from Sun Pharma and Apotex with
respect to certain of the patents listed for Abilify
Maintena
®
in the U.S. and commenced patent
infringement proceedings against both companies.
The FDA will stay approval to Sun and Apotex until 30
months from receipt of the respective paragraph IV
certifications or a court decision in Sun’s and/or
Apotex’ favor.
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 JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 22
Registered Executive Management
Board of Directors
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 23
3 CONDENSED FINANCIAL STATEMENTS
CONDENSED STATEMENT OF PROFIT OR LOSS
DKK million
9M 2024
9M 2023
Q3 2024
Q3 2023
Revenue
Cost of sales
Gross profit
Sales and distribution costs
Administrative expenses
Research and development costs
Profit from operations (EBIT)
Net financials, (income)/expenses
Profit before tax
Tax on profit for the period
(45 )
Profit for the period
Earnings per share, basic (EPS) (DKK)
Earnings per share, diluted (DEPS) (DKK)
STATEMENT OF COMPREHENSIVE INCOME
DKK million
9M 2024
9M 2023
Q3 2024
Q3 2023
Profit for the period
Actuarial gains/losses
Tax
Items that will not be reclassified subsequently to profit or loss
Exchange rate gains/losses on investments in foreign subsidiaries
(105 )
(447 )
Exchange rate gains/losses on additions to net investments in
foreign subsidiaries
(29 )
(86 )
(46 )
Hedging of net investments in foreign subsidiaries
Deferred gains/losses on cash flow hedge, exchange rate
(91 )
(214 )
Deferred gains/losses on cash flow hedge, interest rate
(21 )
(5 )
Deferred gains/losses on cash flow hedge, price
(14 )
(58 )
(17 )
Exchange gains/losses, hedging (transferred to the hedged items)
(44 )
(50 )
Tax
(13 )
(77 )
Items that may be reclassified subsequently to profit or loss
(61 )
(38 )
(178 )
Other comprehensive income
(61 )
(38 )
(178 )
Comprehensive income
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 24
CONDENSED STATEMENT OF FINANCIAL POSITION
DKK million
30.09.2024
31.12.2023
Assets
Intangible assets
Property, plant and equipment
Right-of-use assets
Other financial assets
Other receivables
Deferred tax assets
Non-current assets
Inventories
Receivables
Cash and cash equivalents
Current assets
Assets
Equity and liabilities
Share capital
Foreign currency translation reserve
Hedging reserve
Retained earnings
Equity
Retirement benefit obligations
Deferred tax liabilities
Provisions
Bank debt and bond debt
Lease liabilities
Other payables
Non-current liabilities
Retirement benefit obligations
Provisions
Trade payables
Lease liabilities
Income taxes payable
Other payables
Current liabilities
Liabilities
Equity and liabilities
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 25
STATEMENT OF CHANGES IN EQUITY
DKK million
Share
capital
Foreign
currency
translation
reserve
Hedging
reserve
Retained
earnings
Total
equity
Equity at January 1, 2024
Profit for the period
Other comprehensive income
(128 )
(61 )
Comprehensive income
(128 )
Distributed dividends, gross
(697 )
(697 )
Dividends received, treasury shares
Buyback of treasury shares
(46 )
(46 )
Incentive programs
Tax on other transactions in equity
Other transactions
(701 )
(701 )
Equity at September 30, 2024
DKK million
Share
capital
Foreign
currency
translation
reserve
Hedging
reserve
Retained
earnings
Total
equity
Equity at January 1, 2023
Profit for the period
Other comprehensive income
(166 )
(38 )
Comprehensive income
(166 )
Distribution of dividends, gross
(578 )
(578 )
Dividends received, treasury shares
Buyback of treasury shares
(43 )
(43 )
Incentive programs
Tax on other transactions in equity
Other transactions
(592 )
(592 )
Equity at September 30, 2023
(10 )
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 26
CONDENSED STATEMENT OF CASH FLOWS
DKK million
9M 2024
9M 2023
Q3 2024
Q3 2023
Profit from operations (EBIT)
Adjustments for non-cash items
Change in working capital
(559 )
(1,311 )
Cash flows from operations before financial receipts and
payments
Financial receipts and payments
(93 )
(20 )
(8 )
Cash flows from ordinary activities
Income taxes paid
(395 )
(309 )
(102 )
(83 )
Cash flows from operating activities
Purchase and sale of intangible assets and property, plant and
equipment
(346 )
(362 )
(101 )
(97 )
Cash flows from investing activities
(346 )
(362 )
(101 )
(97 )
Cash flows from operating and investing activities
(free cash flow)
Repayment of bank loans and borrowings
(1,377 )
(789 )
Dividends paid in the financial year, net
(694 )
(576 )
Other financing activities
(114 )
(111 )
(24 )
(25 )
Cash flows from financing activities
(808 )
(2,064 )
(24 )
(814 )
Net cash flow for the period
Cash and cash equivalents at beginning of period
Unrealized exchange gains/losses on cash and bank balances
(14 )
(13 )
(8 )
Net cash flow for the period
Cash and cash equivalents at end of period
Interest-bearing debt, cash, cash equivalents and securities, net,
is composed as follows:
Cash and cash equivalents
Interest-bearing debt
(4,340 )
(4,294 )
(4,340 )
(4,294 )
Net cash/(net debt)
(46 )
(46 )
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 27
STATEMENT OF PROFIT OR LOSS – ADJUSTED EBITDA RECONCILIATION (9M AND Q3)
9M 2024
9M 2023
DKK million
Reported
Adjusted
Reported
Adjusted
Revenue
16,463
16,463
14,934
14,934
Cost of sales
3,159
1,900
3,277
1,591
Gross profit
13,304
14,563
11,657
13,343
Sales and distribution costs
5,746
5,672
5,297
5,227
Administrative expenses
1,080
917
915
830
Research and development costs
3,385
2,778
2,481
2,427
Profit from operations (EBIT)
3,093
-
2,964
-
Depreciation/amortization
1,402
-
1,499
-
EBITDA
4,495
5,196
4,463
4,859
EBITDA margin
27.3%
31.6%
29.9%
32.5%
Adjustments to EBITDA
Integration costs
-
-
-
-
Restructuring expenses
4
-
15
-
Gains/losses on divestment of businesses
-
-
-
-
Acquisition expenses
-
-
-
-
Other adjustments
697
-
381
-
Adjusted EBITDA
5,196
5,196
4,859
4,859
Adjusted EBITDA margin
31.6%
31.6%
32.5%
32.5%
Q3 2024
Q3 2023
DKK million
Reported
Adjusted
Reported
Adjusted
Revenue
5,722
5,722
4,952
4,952
Cost of sales
1,094
674
1,098
584
Gross profit
4,628
5,048
3,854
4,368
Sales and distribution costs
1,952
1,922
1,796
1,773
Administrative expenses
342
339
351
276
Research and development costs
1,523
956
816
798
Profit from operations (EBIT)
811
-
891
-
Depreciation/amortization
467
-
494
-
EBITDA
1,278
1,831
1,385
1,521
EBITDA margin
22.3%
32.0%
28.0%
30.7%
Adjustments to EBITDA
Integration costs
-
-
-
-
Restructuring expenses
6
-
-
-
Gains/losses on divestment of businesses
-
-
-
-
Acquisition expenses
-
-
-
-
Other adjustments
547
-
136
-
Adjusted EBITDA
1,831
1,831
1,521
1,521
Adjusted EBITDA margin
32.0%
32.0%
30.7%
30.7%
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 28
4 NOTES
4.1 BASIS OF PREPARATION
The interim condensed consolidated financial statements for the first nine months ended September 30, 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 December 31, 2023,
published February 7, 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 2.11 General
corporate matters.
A number of new amendments came into effect from January 1, 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
September 30, 2024
Level 1
Level 2
Level 3
Financial assets
Other financial assets
1
33
-
28
Derivatives
1
-
166
35
Total
33
166
63
Financial liabilities
Contingent consideration
1
-
-
367
Derivatives
1
-
33
-
Bond debt²
3,496
-
-
Total
3,496
33
367
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 IMPAIRMENT LOSS
An impairment loss of DKK 547 million was recognized, as a result of the negative read-out, related to a Compound of
MAGLi family (Lu AG06474 and Lu AG12947), that were acquired in 2019 through a business combination. Management
has decided to close development of molecule Lu AG06474 after readout results did not support additional studies,
resulting in the individual asset being fully impaired. No impact is expected for Lu AG12947.
The value of the family of compounds recognized as product rights prior to impairment was DKK 1,871 million. As of 30
September 2024, the remaining gross carrying amount is 1,324 million, exclusively related to Lu AG12947. Impairment
expenses are presented as research and development costs on the statement of profit or loss.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 29
These impairments were calculated using value in use models, no changes in methodology occurred compared to 31
December 2023.
4.4 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.
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 JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 30
FINANCIAL CALENDAR 2025
February 5, 2025: Corporate release for the full year 2024
February 5, 2025: Annual Report 2024
February 11, 2025: Deadline for the company’s receipts of shareholder proposals for the Annual
General Meeting
March 26, 2025: Lundbeck Annual General Meeting
March 31, 2025: Dividends for 2024 at the disposal of shareholders (if proposed/approved)
May 14, 2025: Financial statements for the first three months of 2025
August 20, 2025: Financial statements for the first six months of 2025
November 12, 2025: Financial statements for the first nine months of 2025
Lundbeck contacts
Investors:
Media:
Palle Holm Olesen
Thomas Mikkel Mortensen
Vice President, Investor Relations
Media Relations Lead
+45 30 83 24 26
+45 30 83 30 24
About H. Lundbeck A/S
Lundbeck is a biopharmaceutical company focused exclusively on brain health. With more than 70 years of experience
in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.
Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly
improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by
curiously exploring new opportunities for treatments.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex
neurological challenges. We develop transformative medicines targeting people for whom there are few or no
treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and
neurology.
We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our
shareholders by making a positive contribution to patients, their families and society as a whole.
Lundbeck has approximately 5,500 employees in more than 50 countries and our products are available in more than
80 countries. For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect
with us via LinkedIn.
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 31
IMPORTANT INFORMATION FOR INVESTORS AND SECURITY HOLDERS
This corporate release is not an offer to buy or the solicitation of an offer to sell any securities. The solicitation
and the offer to buy shares of Longboard common stock have been made pursuant to a tender offer statement
on Schedule TO, containing an offer to purchase and related materials, filed by Lundbeck with the U.S. Securities
and Exchange Commission (the SEC) on October 30, 2024. Longboard filed a Solicitation/Recommendation
Statement on Schedule 14D-9 with respect to the tender offer with the SEC on October 30, 2024. Investors and
Longboard’s stockholders are strongly advised to read the tender offer materials carefully (including the offer to
purchase, the related letter of transmittal and certain other offer documents) and any amendments thereto from
time to time, as well as the Solicitation/Recommendation Statement on Schedule 14D-9, and any other
documents filed with the SEC, because they contain important information about such tender offer that
Longboard’s stockholders should consider prior to making any decision regarding tendering their shares. All of
these materials (and all other materials filed with the SEC) will be available at no charge from the SEC through
its website at www.sec.gov. Free copies of the offer to purchase, the related letter of transmittal and certain
other offering documents will be made available by Lundbeck and when available may be obtained by directing
a request to the Information Agent for the tender offer named in the Schedule TO. Copies of the documents filed
with the SEC by Longboard will be made available free of charge on Longboard’s internet website at
https://ir.longboardpharma.com/financial-information/sec-filings or by contacting Longboard’s investor
relations contact at [email protected].
In addition to the offer to purchase, the related letter of transmittal and certain other tender offer documents
filed by Lundbeck, as well as the solicitation/recommendation statement filed by Longboard, Longboard will also
file annual, quarterly and current reports with the SEC. You may read and copy any reports or other information
filed by Lundbeck or Longboard at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549.
Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. Longboard’s filings
with the SEC are also available to the public from commercial document-retrieval services and at the website
maintained by the SEC at http://www.sec.gov.
Safe Harbor/Forward-Looking Statements
This corporate release contains forward-looking statements that provide our expectations or forecasts of future
events such as new product introductions, product approvals and financial performance. Forward-looking
statements include, without limitation, any statement that may predict, forecast, indicate or imply future
results, performance or achievements, and may contain words like "believe", "anticipate", "expect", "estimate",
"intend", "plan", "project", "will be", "will continue", "will result", "could", "may", "might", or any variations of
such words or other words with similar meanings. All statements other than statements of historical facts
included in this corporate release, including, without limitation, those regarding Lundbeck and Longboard’s
financial position, business strategy, plans and objectives of management for future operations (including
development plans and objectives relating to Lundbeck and Longboard's products), are forward-looking
statements.
Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may
cause Lundbeck and Longboard's actual results, performance or achievements to be materially different from
any future results, performance or achievements expressed or implied by such forward-looking statements.
Factors that may affect future results include, among others, interest rate and currency exchange rate
fluctuations; delay or failure of development projects, production or distribution problems; unexpected contract
breaches or terminations; government-mandated or market-driven price decreases for Lundbeck's 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
related interpretation thereof; and unexpected growth in costs and expenses. Additional risks and uncertainties
include, but are not limited to, risks related to Lundbeck’s ability to complete the transaction on the proposed
terms and schedule; whether the tender offer conditions will be satisfied; whether sufficient stockholders of
Longboard tender their shares in the transaction; the outcome of legal proceedings that may be instituted
FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Corporate Release No 763/2024
Page 32
against Longboard and/or others relating to the transaction; the failure to receive (or delay in receiving) the
required regulatory approvals relating to the transaction; the possibility that competing offers will be made; risks
associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such
integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the
transaction will not occur; risks related to future opportunities and plans for Longboard and its products,
including uncertainty of the expected financial performance of Longboard and its products; disruption from the
proposed transaction, making it more difficult to conduct business as usual or maintain relationships with
customers, employees or suppliers; the occurrence of any event, change or other circumstance that could give
rise to the termination of the acquisition agreement; and other uncertainties pertaining to the business of
Longboard, including those detailed in Longboard’s public filings with the SEC from time to time, including
Longboard’s most recent Annual Report on Form 10-K for the year ended December 31, 2023 and its subsequent
Quarterly Reports on Form 10-Q. The reader is cautioned not to unduly rely on these forward-looking statements.
The forward-looking statements in this corporate release and any oral presentations speak only as at the date of
this corporate release. Longboard and Lundbeck disclaim any intent or obligation to update or revise these
forward-looking statements, or to confirm such statements to reflect subsequent events or circumstances after
the date of the company release or in relation to actual results, other than as may be required under applicable
law or applicable stock exchange regulations.
Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material
corporate information. Some assumptions, including assumptions relating to sales associated with products
that are prescribed for unapproved uses, are made considering past performances of other similar drugs for
similar disease states or past performance of the same drug in other regions where the product is currently
marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in
the U.S., prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck,
promotion of unapproved uses is strictly prohibited.