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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report
(Date of earliest event reported): October 31, 2024
Organon &
Co.
(Exact name of registrant
as specified in its charter)
| Delaware |
|
001-40235 |
|
46-4838035 |
| (State or other jurisdiction of |
|
(Commission File Number) |
|
(I.R.S. Employer Identification
No.) |
| incorporation) |
|
| |
|
| |
|
|
|
|
30 Hudson Street, Floor 33,
Jersey City, NJ |
|
|
|
07302 |
| (Address and principal executive offices) |
|
|
|
(Zip Code) |
| Registrant’s telephone number, including area code: (551) 430-6900 |
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of
each exchange on which registered |
| Common Stock, par value $0.01 per share |
|
OGN |
|
NYSE |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ¨
| Item 2.02 |
Results of Operations and Financial Condition. |
On October 31, 2024, Organon & Co.
(the “Company”) issued a press release (the “Earnings Release”) regarding its results for the quarter
ended September 30, 2024. The Earnings Release is included as Exhibit 99.1 to this report.
The information contained in this Item 2.02, including
Exhibit 99.1 attached hereto, is considered to be “furnished” and shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to
liability under that Section. The information in this Current Report shall not be incorporated by reference into any filing or other document
pursuant to the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, except as shall be expressly
set forth by specific reference in such filing or document. The release contains forward-looking statements regarding the Company and
includes a cautionary statement identifying important factors that could cause actual results to differ materially from those anticipated.
| Item 7.01 |
Regulation FD Disclosure. |
In connection with the conference call announced
in the Earnings Release, on October 31, 2024, the Company made available the Company Information Presentation relating to its financial
results for the quarter ended September 30, 2024. The Company Information Presentation may be accessed within the investor relations
section of the Company’s website, https://www.organon.com. A copy of the Company Information Presentation is attached hereto as
Exhibit 99.2 and is incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.2
attached hereto, is considered to be “furnished” and shall not be deemed “filed” for purposes of Section 18
of the Exchange Act or otherwise subject to liability under that Section. The information in this Current Report shall not be incorporated
by reference into any filing or other document pursuant to the Securities Act or the Exchange Act, except as shall be expressly set forth
by specific reference in such filing or document. The Company Information Presentation contains forward-looking statements regarding the
Company and includes a cautionary statement identifying important factors that could cause actual results to differ materially from those
anticipated.
| Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the
undersigned, hereunto duly authorized.
| |
Organon &
Co. |
| |
|
| |
By: |
/s/Matthew
Walsh |
| |
|
Name: |
Matthew Walsh |
| |
|
Title: |
Chief Financial Officer |
Dated: October 31, 2024
Exhibit 99.1
| Media Contacts: |
Karissa Peer |
Investor Contacts: |
Jennifer Halchak |
| |
(614) 314-8094 |
|
(201) 275-2711 |
| |
Kate Vossen |
|
Renee McKnight |
| |
(732) 675-8448 |
|
(551) 204-6129 |
Organon Reports Results for the Third Quarter
Ended September 30, 2024
| · | 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 |
Jersey City, N.J., October 31, 2024 – 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 (1) | |
| 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 (1) | |
| 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.
TABLE 4
| Organon & Co. |
| Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued) |
| (Unaudited, $ in millions except per share amounts) |
| | |
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.
Exhibit 99.2
Third Quarter 2024 Earnings Organon
Disclaimer statement Cautionary Note Regarding Forward - Looking Statements Except for historical information, this presentation 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 pr osp ects, 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. For ward - 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 bas ed 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 material ize , 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 ca re 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; diffi culties 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 th e 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 scrut iny ; 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 initiativ es 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 o f, 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 reac tio ns, 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 service s a s agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our pr oducts 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 a nd any resulting public policy changes affecting women and their health care decisions, including changes in financial outcomes resulting from candidate pos iti ons 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 ot her 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, f uture 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 Securiti es 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). 2
Disclaimer statement, cont. Cautionary Note Regarding Non - GAAP Financial Measures This presentation contains “non - GAAP financial measures,” which are financial measures that either exclude or include amounts t hat 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”). Speci fic ally, 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 dilu ted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This presentation also provides certain measures t hat 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 com paring 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 GAA P. 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 pages 20 - 22 of this presentation 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 co mpany 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 expens es, 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 on going 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 t o meaningfully communicate its underlying business performance, financial condition and results of operations. 3 See Slides 20 - 22 of this presentation for a reconciliation of non - GAAP measures.
Third quarter 2024 highlights 4 • Revenue of $1.6 billion, up 5% ex - FX • Diluted EPS of $1.38, Adjusted Diluted EPS of $0.87 • Adjusted EBITDA of $459 million, inclusive of $51 million of IPR&D and milestones See Slides 20 - 22 of this presentation for a reconciliation of non - GAAP measures.
Women's Health 5 AhR = aryl - hydrocarbon receptor agonist, PDE - 4 = phosphodiesterase 4 inhibitor, JAK = janus kinase inhibitor, IL - 4 = interleukin 4 receptor alpha antagonist Biosimilars Women's Health Proposed label vs non - steroidal treatments IL - 4 JAK PDE 4 AhR Dupixent ® 16 Weeks Opzelura ® 8 Weeks Zoryve ® 4 Weeks Eucrisa ® 4 Weeks VTAMA ® 8 Weeks Once Every 2 Weeks - Once Every 4 Weeks Subcutaneous injection Twice Daily Topical cream Short term, ≤20% Body Surface Area Once Daily Topical Cream Twice Daily Topical Ointment Once Daily Topical Cream Dosing regimen Second line Second line First line First line First line Indication >6 months >12 years >6 years >3 months >2 years Population Mod. - Severe Mild - Moderate Mild - Moderate Mild - Moderate Mild - Severe Disease severity No Yes Yes No No Limitations No Yes No No No Boxed Warning No Yes No Yes No Warnings & Precautions 36% / 38% 10% / 9% 54% / 51% 15% / 8% 32% / 29% 15% / 12% 33% / 32% 25% / 18% 45% / 46% 14% / 18% Investigator Global Assessment Score placebo 41% / 36% 12% / 10% 52% / 51% 15% / 16% 34% / 30% 21% / 12% N/A 56 % / 53% 34% / 24% Peak Pruritus placebo *Eucrisa is a trademark registered in the United States in the name of Anacor Pharmaceuticals, LLC. * Zoryve is a trademark registered in the United States in the name of Arcutis Biotherapeutics, Inc. *Opzelura is a trademark registered in the United States in the name of Incyte Holdings Corporation. *Dupixent is a trademark registered in the United States in the name of Sanofi Biotechnology. *Proposed label currently under discussion with FDA, subject to change pending regulatory feedback. * Information based on product labeling as of October 11, 2024, and does not reflect results from a head - to - head study. Differen ces exist between trial designs and subject characteristics, and caution should be exercised when comparing data across studi es.
Women’s Health Women’s Health Ex - FX VPY Act VPY 2023 YTD 2024 YTD Ex - FX VPY Act VPY Q3 - 23 Q3 - 24 Revenues $ mil 18% 17% 599 704 11% 10% 220 243 Nexplanon ® (contraception) (32)% (34)% 137 90 (45)% (45)% 43 23 NuvaRing ® (contraception) 8% 6% 97 103 (2)% (3)% 30 29 Marvelon / Mercilon (contraception) (3)% (4)% 179 171 16% 16% 54 63 Follistim AQ ® (fertility) (6)% (7)% 88 82 4% 3% 25 26 Ganirelix Acetate Injection (fertility) 40% 40% 31 43 24% 24% 13 16 Jada ® (device) 13% 12% 106 119 25% 23% 33 40 Other Women's Health products 7% 6% 1,237 1,312 6% 5% 418 440 Total Women's Health • Strong growth in Nexplanon and Fertility offset expected impact from generics of NuvaRing • Continued uptake in Jada 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 . 6
Biosimilars Biosimilars Ex - FX VPY Act VPY 2023 YTD 2024 YTD Ex - FX VPY Act VPY Q3 - 23 Q3 - 24 Revenues $ mil 4% 4% 201 210 4% 3% 69 72 Renflexis ® 15% 15% 93 107 (49)% (49)% 40 20 Ontruzant ® 39% 38% 45 63 99% 98% 13 27 Brenzys (35)% (35)% 34 22 (44)% (44)% 12 7 Aybintio NM NM 20 98 NM NM 8 40 Hadlima ® 27% 27% 394 499 17% 16% 142 165 Biosimilars 7 • Hadlima uptake continues following U.S. launch • Ontruzant performance reflects timing of tenders in Brazil and lower demand in the U.S. and Europe • Renflexis reaching mature part of lifecycle 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 .
Established Brands Established Brands Ex - FX VPY Act VPY 2023 YTD 2024 YTD Ex - FX VPY Act VPY Q3 - 23 Q3 - 24 Revenues $ mil (7)% (9)% 1,139 1,039 (5)% (7)% 354 331 Cardiovascular (1)% (4)% 790 761 (4)% (5)% 248 237 Respiratory 11% 9% 595 652 5% 4% 210 218 Non - Opioid Pain, Bone & Derm 15% 13% 408 462 36% 35% 123 166 Other 1% (1)% 2,932 2,915 3% 2% 935 951 Total Est. Brands 8 • New migraine products and recovery in injectable steroids offset unfavorable pricing in Japan • Expect flat performance for the franchise in 2024 ex - FX Totals may not foot due to rounding .
+4% as reported, and +5% at constant currency $ mil 9 Volume growth offsets price erosion; minimal LOE and VBP impact (1) LOE = Loss of Exclusivity (2) VBP = Volume Based Procurement (3) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ and other third parties. (3) (1) (2) ~ ~ ~ ~ ~ ~ ~(130) bps headwind
Containment of operating costs partially offset gross margin pressure Actual VPY 2023 YTD 2024 YTD Actual VPY Q3 - 23 Q3 - 24 All numbers presented on non - GAAP basis except revenue and IPR&D (1) 3% 4,665 4,811 4% 1,519 1,582 Revenue 8% 1,699 1,832 7% 568 606 Cost of sales — % 2,966 2,979 3% 951 976 Adjusted Gross profit — % 1,155 1,154 — % 392 391 Selling, general and administrative (14)% 373 321 (19)% 129 105 R&D NM 8 81 NM — 51 Acquired IPR&D and milestones 6% 381 402 21% 129 156 Total research and development including IPR&D 1% 1,495 1,510 3% 447 459 Adjusted EBITDA (2)% 3.26 3.21 — % 0.87 0.87 Adjusted diluted EPS NM (0.03) (0.25) NM — (0.16) Per share impact to diluted EPS from acquired IPR&D and milestones 63.6% 61.9% 62.6% 61.7% Adjusted Gross margin 32.0% 31.4% 29.4% 29.0% Adjusted EBITDA margin (1) See Slides 20 - 22 of this presentation for a reconciliation of non - GAAP measures to their respective GAAP measures. 10
11 YTD Sept. 2023 YTD Sept. 2024 (USD millions) $1,495 $1,510 Adjusted EBITDA (312) (292) Less: Net cash interest expense (145) (152) Less: Cash taxes (492) (297) Less: Change in net working capital (93) (76) Less: CapEx $453 $693 Free Cash Flow Before One - Time Costs (238) (137) Less: One - time spin - related costs (15) (129) Less: Other one - time costs (1) $200 $427 Free Cash Flow (2) • Timing - related improvement in YTD net working capital • Significant decline in spin - related OTC • Expect one - time spin - related costs of ~$150M for full year 2024 • Increase in Other OTC due to Restructuring, MSA Exits and Microspherix settlement On track to deliver ~$1B of free cash flow before one - time spin - related costs for full year 2024 (1) Includes cash payments associated with restructuring initiatives ($60M), planned exits from supply agreements with Merck & C o., Inc., Rahway, NJ. ($44M), and the second payment on the Microspherix settlement ($25M). (2) Free cash flow represents net cash flows provided by operating activities plus capital expenditures and the effect of exc han ge rate changes on cash and cash equivalents.
12 Net leverage ratio ~4.0x at September 30, 2024 Sep 2024 Jun 2024 Mar 2024 Dec 2023 Dec 2022 Dec 2021 $ mil 763 704 575 693 706 737 Cash and cash equivalents 8,749 8,656 8,714 8,760 8,913 9,134 Gross Debt (1) 7,986 7,952 8,139 8,067 8,207 8,397 Net Debt (1) * The definition of net debt is in the company's credit agreement and excludes unamortized fees; but includes capitalized lea se obligations. Additionally, the LTM EBITDA calculation excludes acquired IPR&D and milestone expense. (1) Debt figures are net of discounts and unamortized fees of $124 million, $105 million, $84 million, $79 million, $108 mill ion and $105 million as of December 31, 2021, December 31, 2022, December 31, 2023, March 31, 2024, June 30, 2024 and September 30, 2024, respectively.
2024 expected to be third consecutive year of revenue growth at constant currency $ mil 13 (1) LOE = Loss of Exclusivity (2) VBP = Value Based Procurement (3) Other includes manufacturing sales to Merck and other third parties. (1) (2) (3) +1.8% to +2.6% reported 3.1% to +3.8% constant currency ~(120) - (135) bps headwind to growth in 2024 ~ ~ ~ ~ ~ ~ $6,375 - $6,425
14 Mid - point of range provided October 31, 2024 Productivity, base business Dermavant Nov/Dec impact Unfavorable product mix $51 million IPR&D expense in Q3 2024 Mid - point of range provided August 6, 2024 30.5% ~10 bps ~(30) bps ~(50) bps ~(80) bps 32.0% Full Year 2024 Adjusted EBITDA range revised for IPR&D, product mix
Full Year 2024 Guidance 15 Current guidance Prior guidance as of August 6, 2024 Provided on a non - GAAP basis, except revenue $6.375 B - $6.425 B $6.250 B - $6.450 B Revenues ~61.5% 61.0% - 63.0% Adjusted gross margin $1.55B - $1.60B $1.50 B - $1.70 B SG&A $430M - $470M $400M - $500M R&D $81M* $30M IPR&D $510M - $550M $430M - $530M Total R&D 30.0% - 31.0% 31.0% - 33.0% Adjusted EBITDA margin (Non - GAAP) Unchanged ~$520M Interest Unchanged ~$130M Depreciation Unchanged 18.5% - 20.5% Effective non - GAAP tax rate Unchanged ~259M Fully diluted weighted average shares outstanding *Updated R&D expense guidance includes $51 million of IPR&D and milestone expense incurred year - to - date September 30, 2024. R&D guidance does not take into consideration a forward looking view of IPR&D and milestone expense.
Q&A
Appendix
Franchise performance Ex - FX VPY Actual VPY 2023 YTD 2024 YTD Ex - FX VPY Actual VPY Q3 2023 Q3 2024 $ mil 7% 6% 1,237 1,312 6% 5% 418 440 Women’s Health 27% 27% 394 499 17% 16% 142 165 Biosimilars 1% (1)% 2,932 2,915 3% 2% 935 951 Est. Brands (17)% (17)% 102 85 7% 4% 24 26 Other (1) 5% 3% 4,665 4,811 5% 4% 1,519 1,582 Total Revenues Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ and other third parties. 18
Ex - FX VPY Actual VPY 2023 YTD 2024 YTD Ex - FX VPY Actual VPY Q3 - 23 Q3 - 24 $ mil 7% 7% 1,259 1,343 12% 11% 392 436 Europe and Canada 8% 8% 1,067 1,156 8% 8% 370 398 United States (3)% (7)% 869 806 (6)% (8)% 284 260 Asia Pacific and Japan 16% 12% 687 768 5% 2% 239 243 Latin America, Middle East, Russia and Africa (2)% (4)% 661 634 5% 5% 202 212 China (15)% (15)% 122 104 2% (1)% 32 33 Other (1) 5% 3% 4,665 4,811 5% 4% 1,519 1,582 Total Revenues 19 Totals may not foot due to rounding, and percentages are computed using unrounded amounts. (1) “Other” includes manufacturing sales to Merck and Co., Inc., Rahway, NJ and other third parties. ~75% of YTD sales generated ex - US Strength in EUCAN, US offsetting mandatory pricing revisions in Japan
Reconciliation of GAAP Reported to Non - GAAP Adjusted Metrics ($ in millions) 2023 YTD 2024 YTD Q3 2023 Q3 2024 $ 2,833 $ 2,819 $ 907 $ 923 GAAP Gross Profit Adjusted for: $ 30 $ 6 $ 10 $ — Spin - related costs (1) — 39 $ — $ 14 Manufacturing network costs (2) 13 13 $ 5 $ 4 Stock - based compensation 88 102 $ 29 $ 35 Amortization 2 — — — Other $ 2,966 $ 2,979 $ 951 $ 976 Adjusted Non - GAAP Gross Profit (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 22 . (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc. , R ahway NJ, US. For additional details refer to the EBITDA reconciliation on page 22 . 2023 YTD 2024 YTD Q3 2023 Q3 2024 60.7 % 58.6 % 59.7 % 58.3 % GAAP Gross Margin 2.9 % 3.3 % 2.9 % 3.4 % Total impact of Non - GAAP adjustments 63.6 % 61.9 % 62.6 % 61.7 % Adjusted Non - GAAP Gross Margin 2023 YTD 2024 YTD Q3 2023 Q3 2024 $ 1,424 $ 1,290 $ 538 $ 422 GAAP Selling, general and administrative expenses Adjusted for: $ (131) $ (79) $ (41) $ (10) Spin - related costs (1) (50) (53) (18) (17) Stock - based compensation (88) (4) (87) (4) Other $ 1,155 $ 1,154 $ 392 $ 391 Adjusted Non - GAAP Selling, general and administrative expenses (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 22 . 20
Reconciliation of GAAP Reported to Non - GAAP Adjusted Metrics ($ in millions, except per share amounts) 2023 YTD 2024 YTD Q3 2023 Q3 2024 $ 394 $ 339 $ 137 $ 111 GAAP Research and development expenses Adjusted for: (10) (5) (4) (2) Spin - related costs (1) (11) (13) (4) (4) Stock - based compensation $ 373 $ 321 $ 129 $ 105 Adjusted Non - GAAP Research and development expenses (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 22 . 2023 YTD 2024 YTD Q3 2023 Q3 2024 $ 477 $ 755 $ 58 $ 359 GAAP Reported Net Income Adjusted for: 133 160 44 53 Cost of sales adjustments 269 136 146 31 Selling, general and administrative adjustments 21 18 8 6 Research and development adjustments 4 23 — — Restructuring 13 14 3 4 Other expense, net (82) (276) (36) (227) Tax impact on adjustments above (1) $ 835 $ 830 $ 223 $ 226 Non - GAAP Adjusted Net Income (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 a ppl ying the statutory rate and applicable law of the originating territory of the non - GAAP adjustments. For additional details refer to the EBITDA reconciliation on page 22 . 2023 YTD 2024 YTD Q3 2023 Q3 2024 $ 1.86 $ 2.92 $ 0.23 $ 1.38 GAAP Diluted Earnings per Share $ 1.40 $ 0.29 $ 0.64 $ (0.51) Total impact of Non - GAAP adjustments $ 3.26 $ 3.21 $ 0.87 $ 0.87 Non - GAAP Diluted Earnings per Share 21
GAAP Net Income to Adjusted EBITDA 2023 YTD 2024 YTD Q3 2023 Q3 2024 Unaudited, $ in millions $ 477 $ 755 $ 58 $ 359 Net income 88 93 32 32 Depreciation (1) 88 102 29 35 Amortization 398 388 134 126 Interest expense 92 (77) 22 (152) Tax (benefit) expense $ 1,143 $ 1,261 $ 275 $ 400 EBITDA 4 23 — — Restructuring costs 184 104 58 16 Spin - related costs (2) — 39 — 14 Manufacturing network related (3) 90 4 87 4 Other costs (4) 74 79 27 25 Stock - based compensation $ 1,495 $ 1,510 $ 447 $ 459 Adjusted EBITDA (Non - GAAP) 32.0 % 31.4 % 29.4 % 29.0 % Adjusted EBITDA margin (Non - GAAP) 22 (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 redu ndant 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, as sociated 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., In c., 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 tra nsaction 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 provide meaningful, supplemental, information that the company believes will enhance an investor's und erstanding of the company's ongoing operating performance.
Number of products 14 5 56 Women’s Health Biosimilars Established Brands Broad and diverse portfolio 23 TM TM
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Organon (NYSE:OGN)
Historical Stock Chart
From Nov 2024 to Dec 2024
Organon (NYSE:OGN)
Historical Stock Chart
From Dec 2023 to Dec 2024
