- Third quarter 2024 revenue of $1.582 billion, up 4% as-reported
and up 5% at constant currency
- Third quarter 2024 diluted earnings per share of $1.38 and
non-GAAP Adjusted diluted earnings per share of $0.87; both
reported and non-GAAP Adjusted diluted earnings per share include
$51 million of expense, or $0.16 per share, for acquired in-process
research and development (IPR&D) and milestones
- Third quarter 2024 net income of $359 million and Adjusted
EBITDA (non-GAAP) of $459 million
- Guidance range for full year 2024 revenue narrowed to $6.375
billion to $6.425 billion, mid-point of the range raised by $50
million; Guidance range for Adjusted EBITDA margin (non-GAAP)
revised to 30.0% to 31.0%, inclusive of the $51 million of
IPR&D expense incurred in the third quarter
Organon (NYSE: OGN) today announced its results for the third
quarter ended September 30, 2024.
"In 2024 our commercial execution has been very strong. Our
largest product, Nexplanon, is well positioned to deliver $1
billion of revenue next year and we've added other notable growth
drivers with Emgality and most recently, VTAMA," said Kevin Ali,
Organon's Chief Executive Officer. "Further, we have been extremely
disciplined on operating costs and driving Adjusted EBITDA growth
in support of achieving $1 billion of free cash flow before
one-time costs for full year 2024."
Third Quarter 2024
Revenue
in $ millions
Q3 2024
Q3 2023
VPY
VPY ex-FX
Women’s Health
$
440
$
418
5%
6%
Biosimilars
165
142
16%
17%
Established Brands
951
935
2%
3%
Other (1)
26
24
4%
7%
Revenues
$
1,582
$
1,519
4%
5%
Totals may not foot due to rounding and
percentages are computed using unrounded amounts.
(1) Other includes manufacturing sales to
third parties.
For the third quarter of 2024, total revenue was $1.582 billion,
up 4% as-reported and up 5% excluding the impact of foreign
currency (ex-FX).
Women's Health revenue increased 5% as-reported and 6% ex-FX in
the third quarter of 2024 compared with the third quarter of 2023
primarily driven by 11% ex-FX growth in Nexplanon® (etonogestrel
implant). Nexplanon's strong performance was primarily due to
increased demand, favorable price and discount rates in the United
States and increased demand in international markets, partially
offset by the timing of tenders in Latin America. The company's
fertility portfolio grew 14% ex-FX as a result of increased demand
in the United States, and to a lesser extent, launches in various
international markets, partially offset by unfavorable discount
rates in the United States.
Performance in the Women's Health franchise was partially offset
by sales of NuvaRing® (etonogestrel / ethinyl estradiol vaginal
ring), a vaginal contraceptive product, which declined 45% ex-FX
during the period due to ongoing generic competition and the
negative impact of increased government discount rates in the
United States.
Biosimilars revenue grew 16% as-reported basis and 17% ex-FX in
the third quarter of 2024, compared with the third quarter of 2023,
primarily due to the uptake of Hadlima® (adalimumab-bwwd) since its
July 2023 launch in the U.S. Sales of Renflexis® (infliximab-abda)
increased 4% ex-FX in the third quarter primarily due to continued
demand growth in the U.S. and Canada partially offset by
unfavorable discount rates in the U.S. Sales of Ontruzant®
(trastuzumab-dttb) declined 49% ex-FX in the period due to the
timing of tenders in Brazil and lower demand in the U.S. and
Europe.
Established Brands revenue grew 2% as-reported 3% ex-FX in the
third quarter of 2024. Contribution from the recent licensing of
Emgality® (galcanezumab-gnlm)(1), growth in China and recovery in
injectable steroids were the strongest drivers of third quarter's
9% volume growth which more than offset unfavorable pricing in
Japan. The company expects revenue growth in the Established Brands
franchise to be approximately flat for full year 2024 on an ex-FX
basis.
(1) Emgality is a trademark registered in the United States in
the name of Eli Lilly and Company (used under license).
Third Quarter 2024
Profitability
in $ millions, except per share
amounts
Q3 2024
Q3 2023
VPY
Revenues
$
1,582
$
1,519
4%
Cost of sales
659
612
8%
Gross profit
923
907
2%
Non-GAAP Adjusted gross profit (1)
976
951
3%
Net income
359
58
519%
Non-GAAP Adjusted net income (1)
226
223
1%
Diluted Earnings per Share (EPS)
1.38
0.23
500%
Non-GAAP Adjusted diluted EPS (1)
0.87
0.87
—%
Acquired IPR&D and milestones
51
—
NM
Per share impact to diluted EPS from
acquired IPR&D and milestones
(0.16
)
—
NM
Adjusted EBITDA (Non-GAAP) (1,2)
459
447
3%
Q3 2024
Q3 2023
Gross margin
58.3
%
59.7
%
Non-GAAP Adjusted gross margin (1)
61.7
%
62.6
%
Adjusted EBITDA margin (Non-GAAP) (1,
2)
29.0
%
29.4
%
(1)
See Tables 4 and 5 for
reconciliations of GAAP to non-GAAP financial measures.
(2)
Adjusted EBITDA and Adjusted
EBITDA margin included $51 million in the third quarter of 2024
related to Acquired IPR&D and milestones. There was no Acquired
IPR&D in the third quarter of 2023.
Gross margin was 58.3% as-reported and 61.7% on a non-GAAP
adjusted basis in the third quarter of 2024 compared with 59.7%
as-reported and 62.6% on a non-GAAP adjusted basis in the third
quarter of 2023. The lower Adjusted gross margin was primarily
related to unfavorable product mix and price.
Net income for the third quarter of 2024 was $359 million, or
$1.38 per diluted share, compared with $58 million, or $0.23 per
diluted share, in the third quarter of 2023. Non-GAAP Adjusted net
income was $226 million, or $0.87 per diluted share, compared with
$223 million, or $0.87 per diluted share, in 2023. GAAP net income
benefited from the release of a valuation allowance in the amount
of $210 million against a tax asset of one of the company's Swiss
entities.
Non-GAAP Adjusted EBITDA margin was 29.0% in the third quarter
of 2024 compared with 29.4% in the third quarter of 2023 primarily
due to $51 million of IPR&D expense in the third quarter of
2024 compared with no such expense in the prior year period.
Selling, general and administrative and research and development
expenses were down 5% year over year as a result of the company's
cost containment efforts including lower clinical spend and a
reduction in headcount related to restructuring initiatives and
lower cost associated with the implementation of the company's ERP
system.
Capital Allocation
Today, Organon’s Board of Directors declared a quarterly
dividend of $0.28 for each issued and outstanding share of the
company's common stock. The dividend is payable on December 12,
2024, to stockholders of record at the close of business on
November 12, 2024.
As of September 30, 2024, cash and cash equivalents were $763
million, and debt was $8.7 billion.
Full Year Guidance
Organon does not provide GAAP financial measures on a
forward-looking basis because the company cannot predict with
reasonable certainty and without unreasonable effort, the ultimate
outcome of legal proceedings, unusual gains and losses, the
occurrence of matters creating GAAP tax impacts, and
acquisition-related expenses. These items are uncertain, depend on
various factors, and could be material to Organon’s results
computed in accordance with GAAP.
Full year 2024 financial guidance is presented below on a
non-GAAP basis, except revenue.
Previous guidance as
of
August 6, 2024
Current guidance
Revenues
$6.250 B - $6.450 B
$6.375 B - $6.425 B
Adjusted gross margin
61.0% - 63.0%
~61.5%
SG&A
$1.50 B - $1.70 B
$1.55B - $1.60B
R&D
$400M - $500M
$430M - $470M
IPR&D
$30M
$81M*
Total R&D
$430M - $530M
$510M - $550M
Adjusted EBITDA margin (Non-GAAP)
31.0% - 33.0%
30.0% - 31.0%
Interest
~$520M
Unchanged
Depreciation
~$130M
Unchanged
Effective non-GAAP tax rate
18.5% - 20.5%
Unchanged
Fully diluted weighted average shares
outstanding
~259M
Unchanged
*Updated R&D expense guidance includes $51 million of
IPR&D and milestone expense incurred in the quarter ended
September 30, 2024. R&D guidance does not take into
consideration a forward-looking view of IPR&D and milestone
expense.
Webcast Information
Organon will host a conference call at 8:30 a.m. Eastern Time
today to discuss its third quarter 2024 financial results. To
listen to the event and view the presentation slides via webcast,
join from the Organon Investor Relations website at
https://www.organon.com/investor-relations/events-and-presentations/.
A replay of the webcast will be available approximately two hours
after the conclusion of the live event on the company’s website.
Institutional investors and analysts interested in participating in
the call must register in advance by clicking on this link:
https://registrations.events/direct/Q4I58511172
Following registration, participants will receive a confirmation
email containing details on how to join the conference call,
including dial-in information and a unique passcode and registrant
ID. Pre-registration will allow participants to bypass an operator
and be placed directly into the call.
About Organon
Organon is an independent global healthcare company with a
mission to help improve the health of women throughout their lives.
Organon’s diverse portfolio offers more than 60 medicines and
products in women’s health, biosimilars, and a large franchise of
established medicines across a range of therapeutic areas. In
addition to Organon’s current products, the company invests in
innovative solutions and research to drive future growth
opportunities in women’s health and biosimilars. In addition,
Organon is pursuing opportunities to collaborate with
biopharmaceutical partners and innovators looking to commercialize
their products by leveraging its scale and agile presence in fast
growing international markets.
Organon has geographic scope with significant reach, world-class
commercial capabilities, and approximately 10,000 employees with
headquarters located in Jersey City, New Jersey.
For more information, visit http://www.organon.com and connect
with us on LinkedIn, Instagram, X (formerly known as Twitter) and
Facebook.
Cautionary Note Regarding Non-GAAP
Financial Measures
This press release contains “non-GAAP financial measures,” which
are financial measures that either exclude or include amounts that
are correspondingly not excluded or included in the most directly
comparable measures calculated and presented in accordance with
U.S. generally accepted accounting principles (“GAAP”).
Specifically, the company makes use of the non-GAAP financial
measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted gross
margin, Adjusted gross profit, Adjusted net income, and Adjusted
diluted EPS, which are not recognized terms under GAAP and are
presented only as a supplement to the company’s GAAP financial
statements. This press release also provides certain measures that
exclude the impact of foreign exchange. We calculate foreign
exchange by converting our current-period local currency financial
results using the prior period average currency rates and comparing
these adjusted amounts to our current-period results. The company
believes that these non-GAAP financial measures help to enhance an
understanding of the company’s financial performance. However, the
presentation of these measures has limitations as an analytical
tool and should not be considered in isolation, or as a substitute
for the company’s results as reported under GAAP. Because not all
companies use identical calculations, the presentations of these
non-GAAP measures may not be comparable to other similarly titled
measures of other companies. Please refer to Table 4 and Table 5 of
this press release for additional information, including relevant
definitions and reconciliations of non-GAAP financial measures
contained herein to the most directly comparable GAAP measures.
In addition, the company’s full-year 2024 guidance measures
(other than revenue) are provided on a non-GAAP basis because the
company is unable to reasonably predict certain items contained in
the GAAP measures. Such items include, but are not limited to,
acquisition related expenses, restructuring and related expenses,
stock-based compensation, the ultimate outcome of legal
proceedings, unusual gains and losses, the occurrence of matters
creating GAAP tax impacts and other items not reflective of the
company's ongoing operations.
The company’s management uses the non-GAAP financial measures
described above to evaluate the company’s performance and to guide
operational and financial decision making. Further, the company’s
management believes that these non-GAAP financial measures, which
exclude certain items, help to enhance its ability to meaningfully
communicate its underlying business performance, financial
condition and results of operations.
Cautionary Note Regarding
Forward-Looking Statements
Except for historical information, this press release includes
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, including, but not limited to, statements about management’s
expectations about Organon’s future financial performance and
prospects, including full-year 2024 guidance estimates and
predictions regarding other financial information and metrics, and
franchise and product performance and strategy expectations for
future periods. Forward-looking statements may be identified by
words such as “will,” “pursuing,” “expects,” “intends,” “plans,”
“believes,” “seeks,” “estimates,” “will” or words of similar
meaning. These statements are based upon the current beliefs and
expectations of the company’s management and are subject to
significant risks and uncertainties. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual
results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include, but are not limited to, pricing
pressures globally, including rules and practices of managed care
groups, judicial decisions and governmental laws and regulations
related to Medicare, Medicaid and health care reform,
pharmaceutical reimbursement and pricing in general; an inability
to fully execute on our product development and commercialization
plans in the United States, Europe, and elsewhere internationally;
an inability to adapt to the industry-wide trend toward highly
discounted channels; difficulties implementing or executing on
Organon’s acquisition strategy, difficulties integrating such
acquisitions (including its recent acquisition of Dermavant
Sciences Ltd.) or any other failure to recognize the benefits of
such acquisitions; changes in tax laws or other tax guidance which
could adversely affect our cash tax liability, effective tax rates,
and results of operations and lead to greater audit scrutiny;
expanded brand and class competition in the markets in which the
company operates; global tensions, which may result in disruptions
in the broader global economic environment; governmental
initiatives that adversely impact our marketing activities,
particularly in China; volatility in our stock price; political and
social pressures, or regulatory developments, that adversely impact
demand for, availability of, or patient access to contraception or
fertility products; recent Supreme Court decisions and other
developments impacting regulatory agencies and their rule making,
including related financial market reactions, tax planning and
international trade practices; difficulties with performance of
third parties we rely on for our business growth; the failure of
any supplier to provide substances, materials, or services as
agreed; the increased cost of supply, manufacturing, packaging, and
operations; difficulties developing and sustaining relationships
with commercial counterparties; competition from generic products
as our products lose patent protection; any failure by us to obtain
an additional period of market exclusivity in the United States for
Nexplanon subsequent to the expiration of certain current patents
in 2027; the impact of the 2024 United States presidential election
and any resulting public policy changes affecting women and their
health care decisions, including changes in financial outcomes
resulting from candidate positions on healthcare topics and the
possible impact on related laws, regulations and policies following
the election; the impact of higher selling and promotional costs;
and the impact of cyberattacks or other events that may affect
Organon’s information technology systems or those of third
parties.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s filings
with the Securities and Exchange Commission ("SEC"), including the
company’s most recent Annual Report on Form 10-K and subsequent SEC
filings, available at the SEC’s Internet site (www.sec.gov).
TABLE 1
Organon & Co.
Condensed Consolidated
Statement of Income
(Unaudited, $ in millions except
shares in thousands and per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Revenues
$
1,582
$
1,519
$
4,811
$
4,665
Cost of sales
659
612
1,992
1,832
Gross Profit
923
907
2,819
2,833
Selling, general and administrative
422
538
1,290
1,424
Research and development
111
137
339
394
Acquired in-process research and
development and milestones
51
—
81
8
Restructuring costs
—
—
23
4
Interest expense
126
134
388
398
Exchange losses
6
14
11
25
Other expense, net
—
4
9
11
Income before income taxes
207
80
678
569
Tax (benefit) expense
(152
)
22
(77
)
92
Net income
$
359
$
58
$
755
$
477
Earnings per share:
Basic
$
1.39
$
0.23
$
2.94
$
1.87
Diluted
$
1.38
$
0.23
$
2.92
$
1.86
Weighted average shares outstanding:
Basic
257,498
255,588
256,830
255,112
Diluted
259,757
256,349
258,908
256,162
TABLE 2
Organon & Co.
Sales by top products
(Unaudited, $ in millions)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
U.S.
Int’l
Total
U.S.
Int’l
Total
U.S.
Int’l
Total
U.S.
Int’l
Total
Women’s Health
Nexplanon/Implanon NXT
$
172
$
70
$
243
$
146
$
74
$
220
$
497
$
207
$
704
$
418
$
181
$
599
Follistim AQ
26
37
63
22
32
54
59
113
171
74
105
179
NuvaRing (1)
7
17
23
23
20
43
33
57
90
70
67
137
Ganirelix Acetate Injection
5
20
26
4
21
25
16
65
82
15
74
88
Marvelon/Mercilon
—
29
29
—
30
30
—
103
103
—
97
97
Jada
15
—
16
12
—
13
42
1
43
30
—
31
Other Women’s Health (1) (2)
14
28
40
11
22
33
41
78
119
32
74
106
Biosimilars
Renflexis
56
16
72
57
12
69
167
43
210
172
29
201
Ontruzant
5
15
20
11
28
40
23
84
107
36
57
93
Brenzys
—
27
27
—
13
13
—
63
63
—
45
45
Aybintio
—
7
7
—
12
12
—
22
22
—
34
34
Hadlima
29
11
40
2
6
8
71
27
98
2
18
20
Established Brands
Cardiovascular
Zetia (1)
2
80
81
2
68
69
5
235
240
5
248
253
Vytorin
1
25
26
2
31
33
4
78
82
5
95
100
Atozet
—
125
125
—
126
126
—
396
396
—
397
397
Rosuzet
—
11
11
—
17
17
—
36
36
—
52
52
Cozaar/Hyzaar
2
57
59
3
65
68
7
179
186
8
217
225
Other Cardiovascular (1) (2)
—
27
29
1
39
41
2
97
99
2
110
112
Respiratory
Singulair
2
83
85
3
88
91
7
268
275
8
282
290
Nasonex (1)
—
63
63
—
60
60
—
200
200
—
197
197
Dulera
38
10
48
40
9
49
120
31
151
116
28
144
Clarinex
1
26
27
2
26
28
2
97
100
4
103
107
Other Respiratory (1) (2)
11
3
14
17
3
20
26
10
35
42
10
52
Non-Opioid Pain, Bone and Dermatology
Arcoxia
—
69
69
—
64
64
—
211
211
—
207
207
Fosamax
1
37
38
1
40
41
3
109
112
2
121
123
Diprospan
—
37
37
—
31
31
—
102
102
—
58
58
Other Non-Opioid Pain, Bone and
Dermatology (2)
5
69
74
4
70
74
15
212
227
11
196
207
Other
Emgality/Rayvow
—
29
29
—
—
—
—
69
69
—
—
—
Proscar
—
23
23
—
25
25
1
72
73
1
76
77
Propecia
2
27
28
2
21
22
5
74
79
5
86
92
Other (2)
3
80
84
5
72
76
12
229
241
10
231
240
Other (3)
1
26
26
—
24
24
(2
)
87
85
(1
)
103
102
Revenues
$
398
$
1,184
$
1,582
$
370
$
1,149
$
1,519
$
1,156
$
3,655
$
4,811
$
1,067
$
3,598
$
4,665
Totals may not foot due to rounding.
Trademarks appearing above in italics are trademarks of, or are
used under license by, the Organon group of companies.
(1) Sales of the authorized generic versions of
NuvaRing,
Zetia and
Nasonex were previously included in other and
have been reclassified to their respective brand name product.
(2) Includes sales of products not listed
separately.
(3) Includes manufacturing sales to third
parties.
TABLE 3
Organon & Co.
Sales by geographic
area
(Unaudited, $ in millions)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Europe and Canada
$
436
$
392
$
1,343
$
1,259
United States
398
370
1,156
1,067
Asia Pacific and Japan
260
284
806
869
China
212
202
634
661
Latin America, Middle East, Russia, and
Africa
243
239
768
687
Other (1)
33
32
104
122
Revenues
$
1,582
$
1,519
$
4,811
$
4,665
(1) Primarily reflects manufacturing sales
to third parties.
TABLE 4
Organon & Co.
Reconciliation of GAAP
Reported to Non-GAAP Adjusted Metrics
(Unaudited, $ in millions)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP Gross Profit
$
923
$
907
$
2,819
$
2,833
Adjusted for:
Spin-related costs (1)
—
10
6
30
Manufacturing network costs (2)
14
—
39
—
Stock-based compensation
4
5
13
13
Amortization
35
29
102
88
Other
—
—
—
2
Adjusted Non-GAAP Gross Profit
$
976
$
951
$
2,979
$
2,966
(1) Spin-related costs include costs from
the separation of Merck & Co., Inc., Rahway, NJ, US. For
additional details refer to Table 5.
(2) Manufacturing network related costs
include costs from exiting manufacturing and supply agreements with
Merck & Co., Inc., Rahway NJ, US. For additional details refer
to Table 5.
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP Gross Margin
58.3
%
59.7
%
58.6
%
60.7
%
Total impact of Non-GAAP adjustments
3.4
%
2.9
%
3.3
%
2.9
%
Adjusted Non-GAAP Gross Margin
61.7
%
62.6
%
61.9
%
63.6
%
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP Selling, general and
administrative expenses
$
422
$
538
$
1,290
$
1,424
Adjusted for:
Spin-related costs (1)
(10
)
(41
)
(79
)
(131
)
Stock-based compensation
(17
)
(18
)
(53
)
(50
)
Other
(4
)
(87
)
(4
)
(88
)
Adjusted Non-GAAP Selling, general and
administrative expenses
$
391
$
392
$
1,154
$
1,155
(1) Spin-related costs include costs from
the separation of Merck & Co., Inc., Rahway, NJ, US. For
additional details refer to Table 5.
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP Research and development
expenses
$
111
$
137
$
339
$
394
Adjusted for:
Spin-related costs (1)
(2
)
(4
)
(5
)
(10
)
Stock-based compensation
(4
)
(4
)
(13
)
(11
)
Adjusted Non-GAAP Research and development
expenses
$
105
$
129
$
321
$
373
(1) Spin-related costs include costs from
the separation of Merck & Co., Inc., Rahway, NJ, US. For
additional details refer to Table 5.
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP Reported Net Income
$
359
$
58
$
755
$
477
Adjusted for:
Cost of sales adjustments
53
44
160
133
Selling, general and administrative
adjustments
31
146
136
269
Research and development adjustments
6
8
18
21
Restructuring
—
—
23
4
Other expense, net
4
3
14
13
Tax impact on adjustments above(1)
(227
)
(36
)
(276
)
(82
)
Non-GAAP Adjusted Net Income
$
226
$
223
$
830
$
835
(1) For the three months ended September
30, 2024 and 2023, the GAAP income tax rates were (73.7)% and
27.0%, respectively, the non-GAAP income tax rates were 24.7% and
20.8%, respectively. For the nine months ended September 30, 2024
and 2023, the GAAP income tax rates were (11.3)% and 16.1%,
respectively, the non-GAAP income tax rates were 19.3% and 17.3%,
respectively. These adjustments represent the estimated tax impacts
on the reconciling items by applying the statutory rate and
applicable law of the originating territory of the non-GAAP
adjustments.
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP Diluted Earnings per Share
$
1.38
$
0.23
$
2.92
$
1.86
Total impact of Non-GAAP adjustments
$
(0.51
)
$
0.64
$
0.29
$
1.40
Non-GAAP Diluted Earnings per Share
$
0.87
$
0.87
$
3.21
$
3.26
TABLE 5
Organon & Co.
Reconciliation of GAAP Net
Income to Non-GAAP Adjusted EBITDA
(Unaudited, $ in millions)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Net income
$
359
$
58
$
755
$
477
Depreciation (1)
32
32
93
88
Amortization
35
29
102
88
Interest expense
126
134
388
398
Tax (benefit) expense
(152
)
22
(77
)
92
EBITDA
$
400
$
275
$
1,261
$
1,143
Restructuring costs
—
—
23
4
Spin-related costs (2)
16
58
104
184
Manufacturing network related (3)
14
—
39
—
Other costs (4)
4
87
4
90
Stock-based compensation
25
27
79
74
Adjusted EBITDA (Non-GAAP)
$
459
$
447
$
1,510
$
1,495
Adjusted EBITDA margin (Non-GAAP)
29.0
%
29.4
%
31.4
%
32.0
%
(1) Excludes accelerated depreciation
included in one-time costs.
(2) Spin-related costs reflect certain
costs incurred in connection with activities taken to separate
Organon from Merck & Co., Inc., Rahway, NJ, US. These costs
include, but are not limited to, $7 million and $32 million for the
three months ended September 30, 2024 and 2023, respectively, and
$47 million and $100 million for the nine months ended September
30, 2024 and 2023, respectively, for information technology
infrastructure, primarily related to the implementation of a
stand-alone enterprise resource planning system and redundant
software licensing costs, as well as $6 million for the three
months ended September 30, 2023 and $20 million and $20 million for
the nine months ended September 30, 2024 and 2023, respectively,
associated with temporary transition service agreements with Merck
& Co., Inc., Rahway, NJ, US.
(3) Manufacturing network related costs,
including exiting of temporary manufacturing and supply agreements
with Merck & Co., Inc., Rahway, NJ, US, reflect accelerated
depreciation, exit premiums, technology transfer costs, stability
and qualification batch costs, and third-party contractor
costs.
(4) Other costs for the three and nine
months ended September 30, 2024 and 2023, respectively, include $4
million related to transaction costs associated with the Dermavant
transaction incurred in 2024 and $80 million related to the
Microspherix legal matter incurred in 2023.
As the costs described in (1) through (4)
above are directly related to the separation of Organon and
therefore arise from a one-time event outside of the ordinary
course of the company’s operations, the adjustment of these items
provides meaningful, supplemental, information that the company
believes will enhance an investor's understanding of the company's
ongoing operating performance.
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