UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

SCHEDULE TO

TENDER OFFER STATEMENT UNDER SECTION 14(d)(1) OR 13(e)(1)
OF THE SECURITIES EXCHANGE ACT OF 1934
(Amendment No. 2)
LONGBOARD PHARMACEUTICALS, INC.
(Name of Subject Company (Issuer))
LANGKAWI CORPORATION
(Offeror)
A Direct Wholly Owned Subsidiary of
LUNDBECK LLC
(Parent of Offeror)
An Indirect Wholly Owned Subsidiary of
H. LUNDBECK A/S
(Parent of Offeror)
(Names of Filing Persons (identifying status as offeror, issuer or other person))
Common Stock, par value $0.0001 per share
(Title of Class of Securities)
54300N103
(CUSIP Number of Class of Securities)
Ole Wendler Pedersen
H. Lundbeck A/S
SVP, Global General Counsel
Ottiliavej 9
DK-2500 Valby
Denmark
+45 36 30 13 11
(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Persons)
Copies to:
Alan Zoccollilo, Esq.
Piotr Korzynski, Esq.
Baker & McKenzie LLP
452 Fifth Avenue
New York, NY 10018
(212) 626-4100

Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer.


Check the appropriate boxes below to designate any transactions to which the statement relates:


 
Third-party offer subject to Rule 14d-1.
 
Issuer tender offer subject to Rule 13e-4.
 
Going-private transaction subject to Rule 13e-3.
 
Amendment to Schedule 13D under Rule 13d-2.

Check the following box if the filing is a final amendment reporting the results of the tender offer:  ☐
If applicable, check the appropriate box(es) below to designate the appropriate rule provision(s) relied upon:

Rule 13e-4(i) (Cross-Border Issuer Tender Offer)
Rule 14d-1(d) (Cross-Border Third-Party Tender Offer)



This Amendment No. 2 to the Tender Offer Statement on Schedule TO (this “Amendment”) amends and supplements the Tender Offer Statement on Schedule TO filed with the Securities and Exchange Commission on October 30, 2024 (as it may be amended and supplemented from time to time, the “Schedule TO”) and relates to the offer by Langkawi Corporation, a Delaware corporation (“Purchaser”), a direct wholly owned subsidiary of Lundbeck LLC, a Delaware limited liability company (“Payor”), and an indirect wholly owned subsidiary of H. Lundbeck A/S, a Danish aktieselskab (“Parent”), to acquire all of the outstanding shares of common stock, par value $0.0001 per share (the “Shares”) of Longboard Pharmaceuticals, Inc., a Delaware corporation, for $60.00 per Share, in cash, without interest and subject to any applicable withholding taxes, upon the terms and subject to the conditions set forth in the Offer to Purchase, dated October 30, 2024 (as it may be amended or supplemented from time to time, the “Offer to Purchase”), and the related Letter of Transmittal, copies of which are attached hereto as Exhibits (a)(1)(i) and (a)(1)(ii) to the Schedule TO, respectively.

Except as otherwise set forth in this Amendment, the information set forth in the Schedule TO and the Offer to Purchase remains unchanged and is incorporated herein by reference to the extent relevant to the items in this Amendment. This Amendment is being filed to reflect certain updates as set forth below. Capitalized terms used but not defined herein shall have the meanings ascribed to such terms in the Offer to Purchase.

Item 12. Exhibits.

Item 12 of the Schedule TO is hereby amended and supplemented by adding the following exhibits:

Exhibit No.
 
Description
 
Press Release issued by H. Lundbeck A/S on November 13, 2024.
 
Presentation Slides issued by H. Lundbeck A/S on November 13, 2024.
 
Excerpt of transcript of H. Lundbeck A/S Investor/Analyst Conference Call on November 13, 2024.

*      Filed herewith


SIGNATURES
After due inquiry and to the best knowledge and belief of the undersigned, each of the undersigned certify that the information set forth in this statement is true, complete and correct.

Date: November 14, 2024
   
H. LUNDBECK A/S
   
By:
/s/ Joerg Hornstein
Name:
Joerg Hornstein
Title:
Executive Vice President
   
LUNDBECK LLC
   
By:
/s/ Thomas Gibbs
Name:
Thomas Gibbs
Title:
President
   
LANGKAWI CORPORATION
   
By:
/s/ Thomas Gibbs
Name:
Thomas Gibbs
Title:
President




Exhibit (a)(5)(x)

CORPORATE RELEASE

NOVEMBER 13, 2024

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% CER1 (+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 franchise2: DKK 2,618 million (+10% CER; +10% DKK)
 
Vyepti®: DKK 2,116 million (+76% CER; +76% DKK)
 
Adjusted EBITDA3 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

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
%


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.

Corporate Release No 763/2024
Ottiliavej 9
Phone: +45 3630 1311
Page 1
 
2500 Valby
www.lundbeck.com
 
 
Copenhagen
CVR-no.: 56759913
 

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.

Corporate Release No 763/2024
Page 2

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
CONTENT

1 Financial highlights
4
2 Business performance
5

2.1 Revenue by product
5

2.2 Revenue by geographical area
7

2.3 Gross profit
8

2.4 EBIT and adjusted EBITDA
9

2.5 Net profit and adjusted EPS
10

2.6 Cash flow and balance sheet
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

Corporate Release No 763/2024
Page 3

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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 profit2
   
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
%
               
EBITDA3
   
4,495
     
4,463
     
6
%
   
1
%
EBITDA margin
   
27.3
%
   
29.9
%
               
Adjusted EBITDA4
   
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 profit5
   
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.

Corporate Release No 763/2024
Page 4

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.
 

Corporate Release No 763/2024
Page 5

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.


Corporate Release No 763/2024
Page 6

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.


Corporate Release No 763/2024
Page 7

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.


Corporate Release No 763/2024
Page 8

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.
 

Corporate Release No 763/2024
Page 9

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 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 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.
 
Corporate Release No 763/2024
Page 10

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.
 
Corporate Release No 763/2024
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FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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 profit2
   
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
%
               
EBITDA3
   
1,278
     
1,385
     
(2
%)
   
(8
%)
EBITDA margin
   
22.3
%
   
28.0
%
               
Adjusted EBITDA4
   
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 profit5
   
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 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.

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FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.
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 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.

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.

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FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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) growth1
Around 3 percentage points lower than at CER
Adjusted EBITDA growth1
Around 8 percentage points lower than at CER
Adjusted gross margin2 
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.

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FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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 CER1
   
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 CER1
   
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.
 
Corporate Release No 763/2024
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FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.
 
Project
Area
Phase I
Phase II
 
Phase III
 
Filing/Launch
Hormonal / neuropeptide signaling:
           
Eptinezumab (anti-CGRP)1
Migraine prevention
     
SUN-studies2
   
 
Cluster headache
 
CHRONICLE3
 
ALLEVIATE
   
Lu AG09222 (anti-PACAP mAb)4
Migraine prevention
 
PROCEED
       
Lu AG13909 (anti-ACTH mAb)5
Neuro-hormonal dysfunctions
           
               
Circuitry / neuronal biology:
             
Brexpiprazole6
PTSD
           
MAGLi program7
Neurology
     
Lu AF28996 (D1/D2 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
           
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-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A 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, with a target date (PDUFA date) for completion of the review of February 8, 2025.
 
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FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.


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FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024

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.
 
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FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
ENVIRONMENTAL PERFORMANCE

Category1 
   
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

Category1 
   
9M 2024
     
9M 2023
   
Change2
 
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.

Diversity, Equity and Inclusion
Lundbeck is a diverse company determined to build an inclusive high-performance culture, where all employees can enrich their professional skills and career paths. We are committed to fostering a diverse workforce and an inclusive culture of belonging where everybody can thrive, be their authentic selves, and perform at their best. This includes taking action on gender equality, and Lundbeck has a target to increase the share of the underrepresented gender at senior management level year-on-year.
In the first nine months of 2024, the Gender balance in senior management decreased to 35.7% women, compared to 36.4% in the first nine months of 2023. Despite the decrease compared to the first nine months of 2023, Lundbeck increased the share by 0.4 percentage points in the third quarter of 2024 compared to the second quarter of 2024. The development is due to changes in the Executive Management and their direct reporting lines.
 
GOVERNANCE PERFORMANCE
Corporate Release No 763/2024
Page 19

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
Category1 
   
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.
 
Corporate Release No 763/2024
Page 20

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.
 
Corporate Release No 763/2024
Page 21

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
STATEMENT OF THE BOARD OF DIRECTORS AND THE REGISTERED EXECUTIVE MANAGEMENT
The Board of Directors and the Registered Executive Management have discussed and adopted the financial report of H. Lundbeck A/S for the period January 1 to September 30, 2024. The financial report is presented in accordance with IAS 34 Interim Financial Reporting, as adopted by the EU and additional Danish disclosure requirements for interim financial reports of listed companies.

We consider the accounting policies applied to be appropriate. Accordingly, the financial report gives a true and fair view of the Group’s assets, liabilities and financial position as of September 30, 2024, and of the results of the Group’s operations and cash flows for the period, which ended on September 30, 2024.

In our opinion, the Management’s Review (pages 5-21) gives a true and fair view of activity developments, the Group’s general financial position and the results for the period. It also gives a fair view of the significant risks and uncertainty factors that may affect the Group relative to the disclosures in the Annual Report 2023.

The financial report has not been subject to audit or reviewed by the company’s independent auditors.

Valby, November 13, 2024

Registered Executive Management

Charl Gerhard Van Zyl
Lars Bang
Joerg Hornstein
Per Johan Luthman
President and CEO
Executive Vice President,
Executive Vice President,
Executive Vice President,
  Product Development & Supply
CFO
Research & Development

Board of Directors

Lars Søren Rasmussen
Lene Skole-Sørensen
Santiago Arroyo
Jeffrey Berkowitz
Chair of the Board
Deputy Chair of the Board
   
       
Lars Erik Holmqvist
Jakob Riis
Ilse Dorothea Wenzel
Camilla Gram Andersson
     
Employee representative
       
Hossein Armandi
Dorte Clausen
Lasse Skibsbye
 
Employee representative
Employee representative
Employee representative
 

Corporate Release No 763/2024
Page 22

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
3 CONDENSED FINANCIAL STATEMENTS
 
CONDENSED STATEMENT OF PROFIT OR LOSS

DKK million
   
9M 2024
     
9M 2023
     
Q3 2024
     
Q3 2023
 
Revenue
   
16,463
     
14,934
     
5,722
     
4,952
 
Cost of sales
   
3,159
     
3,277
     
1,094
     
1,098
 
Gross profit
   
13,304
     
11,657
     
4,628
     
3,854
 
 
                               
Sales and distribution costs
   
5,746
     
5,297
     
1,952
     
1,796
 
Administrative expenses
   
1,080
     
915
     
342
     
351
 
Research and development costs
   
3,385
     
2,481
     
1,523
     
816
 
Profit from operations (EBIT)
   
3,093
     
2,964
     
811
     
891
 
                                 
Net financials, (income)/expenses
   
54
     
146
     
79
     
8
 
Profit before tax
   
3,039
     
2,818
     
732
     
883
 
 
                               
Tax on profit for the period
   
486
     
662
     
(45
)
   
207
 
Profit for the period
   
2,553
     
2,156
     
777
     
676
 
 
                               
Earnings per share, basic (EPS) (DKK)
   
2.57
     
2.17
     
0.78
     
0.68
 
Earnings per share, diluted (DEPS) (DKK)
   
2.57
     
2.17
     
0.78
     
0.68
 

STATEMENT OF COMPREHENSIVE INCOME

DKK million
   
9M 2024
     
9M 2023
     
Q3 2024
     
Q3 2023
 
Profit for the period
   
2,553
     
2,156
     
777
     
676
 
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
)
   
182
     
(447
)
   
307
 
Exchange rate gains/losses on additions to net investments in foreign subsidiaries
   
(29
)
   
(86
)
   
35
     
(46
)
Hedging of net investments in foreign subsidiaries
   
-
     
17
     
-
     
-
 
Deferred gains/losses on cash flow hedge, exchange rate
   
57
     
(91
)
   
302
     
(214
)
Deferred gains/losses on cash flow hedge, interest rate
   
-
     
(21
)
   
-
     
(5
)
Deferred gains/losses on cash flow hedge, price
   
(14
)
   
(58
)
   
1
     
(17
)
Exchange gains/losses, hedging (transferred to the hedged items)
   
43
     
(44
)
   
8
     
(50
)
Tax
   
(13
)
   
63
     
(77
)
   
74
 
Items that may be reclassified subsequently to profit or loss
   
(61
)
   
(38
)
   
(178
)
   
49
 
 
                               
Other comprehensive income
   
(61
)
   
(38
)
   
(178
)
   
49
 
Comprehensive income
   
2,492
     
2,118
     
599
     
725
 

Corporate Release No 763/2024
Page 23

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
CONDENSED STATEMENT OF FINANCIAL POSITION

DKK million
   
30.09.2024
     
31.12.2023
 
Assets
               
Intangible assets
   
18,929
     
20,692
 
Property, plant and equipment
   
2,589
     
2,499
 
Right-of-use assets
   
418
     
382
 
Other financial assets
   
87
     
99
 
Other receivables
   
244
     
208
 
Deferred tax assets
   
251
     
238
 
Non-current assets
   
22,518
     
24,118
 
 
               
Inventories
   
4,354
     
4,427
 
Receivables
   
4,322
     
3,852
 
Cash and cash equivalents
   
8,322
     
5,010
 
Current assets
   
16,998
     
13,289
 
 
               
Assets
   
39,516
     
37,407
 
 
               
Equity and liabilities
               
Share capital
   
996
     
996
 
Foreign currency translation reserve
   
981
     
1,109
 
Hedging reserve
   
130
     
63
 
Retained earnings
   
21,729
     
19,877
 
Equity
   
23,836
     
22,045
 
 
               
Retirement benefit obligations
   
220
     
216
 
Deferred tax liabilities
   
2,524
     
2,283
 
Provisions
   
596
     
388
 
Bank debt and bond debt
   
3,718
     
3,714
 
Lease liabilities
   
393
     
351
 
Other payables
   
454
     
420
 
Non-current liabilities
   
7,905
     
7,372
 
 
               
Retirement benefit obligations
   
1
     
1
 
Provisions
   
1,065
     
934
 
Trade payables
   
4,262
     
4,410
 
Lease liabilities
   
77
     
86
 
Income taxes payable
   
450
     
571
 
Other payables
   
1,920
     
1,988
 
Current liabilities
   
7,775
     
7,990
 
 
               
Liabilities
   
15,680
     
15,362
 
 
               
Equity and liabilities
   
39,516
     
37,407
 

Corporate Release No 763/2024
Page 24

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
STATEMENT OF CHANGES IN EQUITY

DKK million
 
Share
capital
   
Foreign
currency
translation
reserve
   
Hedging
reserve
   
Retained
earnings
   
Total
equity
 
Equity at January 1, 2024
   
996
     
1,109
     
63
     
19,877
     
22,045
 
 
                                       
Profit for the period
   
-
     
-
     
-
     
2,553
     
2,553
 
Other comprehensive income
   
-
     
(128
)
   
67
     
-
     
(61
)
Comprehensive income
   
-
     
(128
)
   
67
     
2,553
     
2,492
 
 
                                       
Distributed dividends, gross
   
-
     
-
     
-
     
(697
)
   
(697
)
Dividends received, treasury shares
   
-
     
-
     
-
     
3
     
3
 
Buyback of treasury shares
   
-
     
-
     
-
     
(46
)
   
(46
)
Incentive programs
   
-
     
-
     
-
     
31
     
31
 
Tax on other transactions in equity
   
-
     
-
     
-
     
8
     
8
 
Other transactions
   
-
     
-
     
-
     
(701
)
   
(701
)
 
                                       
Equity at September 30, 2024
   
996
     
981
     
130
     
21,729
     
23,836
 
                                         
                                         

DKK million
 
Share
capital
   
Foreign
currency
translation
reserve
   
Hedging
 reserve
   
Retained
earnings
   
Total
equity
 
Equity at January 1, 2023
   
996
     
1,438
     
156
     
18,189
     
20,779
 
 
                                       
Profit for the period
   
-
     
-
     
-
     
2,156
     
2,156
 
Other comprehensive income
   
-
     
128
     
(166
)
   
-
     
(38
)
Comprehensive income
   
-
     
128
     
(166
)
   
2,156
     
2,118
 
 
                                       
Distribution of dividends, gross
   
-
     
-
     
-
     
(578
)
   
(578
)
Dividends received, treasury shares
   
-
     
-
     
-
     
2
     
2
 
Buyback of treasury shares
   
-
     
-
     
-
     
(43
)
   
(43
)
Incentive programs
   
-
     
-
     
-
     
26
     
26
 
Tax on other transactions in equity
   
-
     
-
     
-
     
1
     
1
 
Other transactions
   
-
     
-
     
-
     
(592
)
   
(592
)
 
                                       
Equity at September 30, 2023
   
996
     
1,566
     
(10
)
   
19,753
     
22,305
 

Corporate Release No 763/2024
Page 25

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
CONDENSED STATEMENT OF CASH FLOWS

DKK million
   
9M 2024
     
9M 2023
     
Q3 2024
     
Q3 2023
 
Profit from operations (EBIT)
   
3,093
     
2,964
     
811
     
891
 
 
                               
Adjustments for non-cash items
   
2,324
     
1,888
     
1,000
     
520
 
Change in working capital
   
(559
)
   
(1,311
)
   
613
     
170
 
Cash flows from operations before financial receipts and payments
   
4,858
     
3,541
     
2,424
     
1,581
 
 
                               
Financial receipts and payments
   
17
     
(93
)
   
(20
)
   
(8
)
Cash flows from ordinary activities
   
4,875
     
3,448
     
2,404
     
1,573
 
 
                               
Income taxes paid
   
(395
)
   
(309
)
   
(102
)
   
(83
)
Cash flows from operating activities
   
4,480
     
3,139
     
2,302
     
1,490
 
 
                               
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)
   
4,134
     
2,777
     
2,201
     
1,393
 
 
                               
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
   
3,326
     
713
     
2,177
     
579
 
 
                               
Cash and cash equivalents at beginning of period
   
5,010
     
3,548
     
6,153
     
3,663
 
Unrealized exchange gains/losses on cash and bank balances
   
(14
)
   
(13
)
   
(8
)
   
6
 
Net cash flow for the period
   
3,326
     
713
     
2,177
     
579
 
Cash and cash equivalents at end of period
   
8,322
     
4,248
     
8,322
     
4,248
 
 
                               
Interest-bearing debt, cash, cash equivalents and securities, net, is composed as follows:
                               
Cash and cash equivalents
   
8,322
     
4,248
     
8,322
     
4,248
 
Interest-bearing debt
   
(4,340
)
   
(4,294
)
   
(4,340
)
   
(4,294
)
Net cash/(net debt)
   
3,982
     
(46
)
   
3,982
     
(46
)

Corporate Release No 763/2024
Page 26

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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
%

Corporate Release No 763/2024
Page 27

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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 assets1
   
33
     
-
     
28
 
Derivatives1
   
-
     
166
     
35
 
Total
   
33
     
166
     
63
 
 
                       
Financial liabilities
                       
Contingent consideration1
   
-
     
-
     
367
 
Derivatives1
   
-
     
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.

Corporate Release No 763/2024
Page 28

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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.

Corporate Release No 763/2024
Page 29

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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
PALO@lundbeck.com
THMR@lundbeck.com
+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.

Corporate Release No 763/2024
Page 30

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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 IR@LongboardPharma.com.

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.

Corporate Release No 763/2024
Page 31

FINANCIAL REPORT FOR THE PERIOD JANUARY 1 TO SEPTEMBER 30, 2024
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 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.


Corporate Release No 763/2024
Page 32


Exhibit (a)(5)(xi)


 Business update & financial results  9M 2024  Martha  Living with depression 
 

 Safe Harbor/Forward-Looking Statements  2  9M 2024 – November 13, 2024  This presentation 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 presentation, 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 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 presentation 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 presentation 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. 
 

 IMPORTANT INFORMATION FOR INVESTORS AND SECURITY HOLDERS  2  9M 2024 – November 13, 2024  This presentation 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 IR@LongboardPharma.com.  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. 
 

 Strong performance across the business in 9M 2024  HSR waiting period has expired and Longboard deal remains on track for an expected December 2024 closing  Revenue grew 13% to DKK 16.5bn  Adjusted EBITDA grew in line with revenue  Adjusted EBITDA margin reached 31.6%  Raised lower end of FY2024  guidance range  All growth rates shown at constant exchange rates (CER). HSR: Hart-Scott-Rodino. TED: Thyroid Eye Disease. 1) Longboard transaction subject to deal closure. Expected December 2024.  Accelerating growth for strategic  brands (+21%)  Exceptional Vyepti growth of +76%  Strong growth for Rexulti (+16%) driven by AADAD  In the pivotal SUNRISE trial, Vyepti significantly reduced mean monthly migraine days compared to placebo  Amlenetug ready to start phase III  Bexicaserin DEEp phase III program started by Longboard1  Solid operational performance  5  9M 2024 – November 13, 2024  Strong growth of strategic brands  Achieved key R&D pipeline milestones 
 

 The R&D pipeline progress continues  Key regulatory activities and major events  Bexicaserin  Phase III program: DEEp SEA (n=160 DS patients1) has been started by Longboard; DEEp OCEAN starting up2  Lu AG22515 (CD40L blocker)  PoC study initiated in Q3 2024 in TED  Amlenetug  MASCOT phase III trial in MSA with highly innovative approach including Bayesian statistics starting up  Vyepti  Asian SUNRISE trial: Vyepti significantly reduced mean monthly  migraine days compared to placebo  All key secondary efficacy endpoints were met  Treatment was well-tolerated  1) NCT06660394. 2) Subject to deal closure. Expected December 2024. DS: Dravet Syndrome. TED: Thyroid Eye Disease. MSA: Multiple System Atrophy. PoC: Proof of Concept.  12  9M 2024 – November 13, 2024 
 

 Guidance FY2024  Raised lower end of financial guidance range for 2024  Expected deal closure of Longboard reflected in updated soft guidance parameters  Guidance FY 2024 based on organic development; (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. Reflects the Longboard acquisition.  Other relevant financial information  Total revenue growth at reported1  Around 3%-points lower than CER  Adjusted EBITDA growth at reported1  Around 8%-points lower than CER  Adjusted gross margin2  88% to 89%  R&D costs  DKK 4.4 to 4.6 billion  Depreciation & amortization  DKK 1.8 to 2.0 billion  Net financial, (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  Previous guidance  Revised guidance  Total revenue growth (CER)  11% - 14%  14%  12%  Adjusted EBITDA growth (CER)  20%  15% - 20% 17%  20  9M 2024 – November 13, 2024 
 

 Majority of DEEs have no approved treatment options  Numbers from U.S. Dravet Syndrome Foundation and U.S. LGS Foundation. Longboard Pharmaceuticals subject to deal closure. Expected December 2024.  Bexicaserin has the potential to address all DEEs  DEE: Developmental and Epileptic Encephalopathies; TSC: Tuberous Sclerosis Complex; CDKL5: Cyclin Dependent Kinase Like 5; EMAS: Epilepsy with Myoclonic-Atonic Seizures.  32  9M 2024 – November 13, 2024  U.S. patient population of approximately 220,000 and half not served by licensed therapies  Sizable opportunities across all DEEs  DEEs without approved drugs  Approximately 100,000 patients  DEEs with approved drugs  Approximately 120,000 patients  Lennox-Gastaut syndrome  Dravet  syndrome  Other  DEEs  Bexicaserin  Pipeline in a mechanism 
 

 Bexicaserin in phase III backed by strong clinical data  A differentiated, highly selective 5-HT2C agonist with a compelling efficacy and safety profile  5-HT: 5-hydroxytryptamine (serotonin) receptors; VHD: Valvular Heart Disease; PAH: Pulmonary Arterial Hypertension; SAD: Single Ascending Dose; CSF: Cerebrospinal Fluid; EEG: Electroencephalogram. Longboard Pharmaceuticals subject to deal closure. Expected December 2024.  Greater selectivity and specificity  Designed to only bind 5-HT2C receptors  No detected activity at receptors associated with significant adverse events with either  5-HT2B (VHD and PAH) or 5-HT2A (psychiatric)  Bexicaserin  Pre-clinical evidence  Reduced seizure, epileptiform activity, duration and number of epileptiform events in fish and rodent models  Phase I – Healthy volunteers  No observed food effect in SAD trial  Plasma and CSF concentration increased in a dose-dependent & consistent manner  Phase II – Multiple DEE populations (PACIFIC)  Topline data communicated in Q1 2024  Global phase III program initiated in Q4 2024 by Longboard  Recent 9-month open-label data confirms strong and durable  seizure reduction of 57.7% in countable motor seizures  33  9M 2024 – November 13, 2024 
 

 Sustainable effects shown in open-label extension study  More than 50% reduction across treatment groups  Longboard Pharmaceutical Investor & Analyst Day September 16, 2024. Longboard Pharmaceuticals subject to deal closure. Expected December 2024.  Median percent reduction in monthly seizure frequency from PACIFIC baseline  9-month open-label extension (OLE)  Transition  to OLE  Month 2  -100  -80  0  -40  -60  -20  Month 3  Month 4  Month 5  Month 6  Month 7  Month 8  Month 9  Month 1  50% reduction  Bexicaserin PACIFIC to bexicaserin OLE Placebo PACIFIC to bexicaserin OLE  Overall  PACIFIC  data set  36  9M 2024 – November 13, 2024 
 

 Solid financial foundation from which to execute on our strategy  9M 2024: Cash flow negatively impacted by  Dividend amounting to DKK 694m  CAPEX investments  Net cash reached DKK 3,982m in 9M 2024 and Net debt/EBITDA was below zero  Following the expected acquisition of Longboard, net debt is expected to reach DKK 12 - 13bn by the end of the year  Strong cash flow leading to continuous deleveraging  711  3.982  -6,000  -4,000  -2,000  0  2,000  4,000  6,000  8,000  1.0  -2.0  -1.5  -1.0  -0.5  0.0  0.5  -8,000  1.5  2.0  Net cash, Net debt and Net debt/EBITDA  DKKm  Net cash/(net debt)  2018  2023  6,635  -6,566  2019  -4,106  -3,189  -2,183  9M 2024  2020  Net cash  2021  Net debt  2022  Net debt/EBITDA  Net debt/EBITDA  68  9M 2024 – November 13, 2024 
 



Exhibit (a)(5)(xii)

The following are excerpts from a transcript from Lundbeck A/S’s presentation held on November 13, 2024.
 
Charl van Zyl - President & CEO
 
And also, the next disclosure I would like to make is also to the agreement between Longboard and Lundbeck that is subject, of course, to closing of the tender offer to be completed.
 
 
And of course, the advance of Bexicaserin into the phase three programme that is started by Longboard.
 
 
Johan Luthman - Executive Vice President, R&D
 
[B]efore I go into those programmes, I'd like to add to Charl's comment on Longboard. The company recently initiated a pivotal Bexicaserin trial in Dravet Syndrome, called DEEp SEA. That trial is now joined by another trial called DEEp OCEAN, which studies a mixed population of developmental and epileptic encephalopathies, with Lennox-Gastaut syndrome patients included.
 
 
Joerg Hornstein - CFO & Executive Vice President, Corporate functions
 
The first nine months of 24, ended with the net cash position of 4 billion, compared to a net debt of 46 million in the first nine months of 23, effectively deleveraging the company ahead of the foreseen closing of the Longboard acquisition.
 
Next slide, please. We have raised the lower end of our financial guidance for 24, and also reflected the impact of the foreseen acquisition of Longboard and the other relevant financial information.  ..
 
Please keep in mind that we have communicated approximately 550 million of integration transaction costs tied to the foreseen acquisition of Longboard. We have the majority will be incurred in Q4 2024 and adjusted for.
 
...
 
Furthermore, the effective tax rate has been updated to reflect the reversal of the uncertain tax position, and our net cash position is now projected to be a net debt position between 12 to 13 billion due to the foreseen acquisition of Longboard.
 
 
Charl van Zyl - President & CEO
 
But also, when we think about long term, clearly the pipeline is evolving, and the work that Johan is doing around evolving the pipeline, including Bexicaserin, subject to closing, will allow us to be in a position in the mid-term to have four programmes that could be in phase three.
 
 
Joerg Hornstein - CFO & Executive Vice President, Corporate functions
 
And, of course, we'll invest into our progressing timeline and also the integration, hopefully, on the foreseen closure of Longboard.
 
 
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Charles Pitman-King          (Barclays)          
 
[A] very quick clarification to your comment on slide 20 and your guidance referring to it as soft guidance parameters. Can I just make sure, are you admitting that there's a potential to end up outside this range, or are you allowing for uncertainty with the relation to Longboard closure? Thank you.
 
 
Charl van Zyl- President & CEO
 
[J]ust to be very clear, I think what Joerg was referring to are the other financial information. So relevant information on slide 20, but maybe not a reference to a soft guidance. We are very firm on our guidance based on what we said today. But I think it was just for completeness to share also the other relevant financial information. So hopefully that clarifies that point.
 
 
Mattias Haeggblom (Handelsbanken)
 
[R]eading the SEC filings with background of the merger related to the proposed acquisition of Longboard, it became even clearer that the breakthrough designation for Bexicaserin, issued by FDA in July, was a driving force for Lundbeck's willingness to hike the offer substantially from its opening offer. So can you perhaps expand with regards to the importance of the breakthrough designation in light of risks and uncertainties with drug development, not least in neurology?
 
 
Charl van Zyl- President & CEO
 
Thank you, Mattias. And Johan can comment in a second. But there’s two drivers, breakthrough designation, but also the willingness from the FDA on a much broader label in the broader population. Those are two big value drivers that came from the end of phase two meeting. But, Johan, do you want to comment on that?
 
Johan Luthman - Executive Vice President, R&D
 
Yes, I think that's pretty much it. It's a unique breakthrough. Designation has not been given before. And this is an area with many smaller indications and a few bigger ones, [inaudible]. And then in August they were even slightly bigger. So, this is the first time to really have this go at a broad label for all these epilepsies. And the breakthrough designation shows how committed FDA is to do something here, but it also adds value to a product like this.
 

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