Full Press Release Details
| Media Contacts: | Karissa Peer | Investor Contacts: | Jennifer Halchak |
| (614) 314-8094 Kate Vossen (732) 675-8448 | (201) 275-2711 Edward Barger (267) 614-4669 |
Organon reports results for the second quarter
| Second quarter 2022 revenues of $1,585 million | ||
| Second quarter diluted earnings per share from continuing operations of $0.92 and non-GAAP adjusted diluted earnings per share from continuing operations of $1.25 | ||
| Both reported and non-GAAP adjusted diluted earnings per share include a negative impact of $0.30 for acquired in-process research and development (IPR&D) and milestones | ||
| Adjusted EBITDA of $512 million, inclusive of $97 million of acquired IPR&D and milestones | ||
| Board of Directors declares quarterly dividend of $0.28 per share | ||
| Full year 2022 financial guidance ranges updated: |
| Revenues range narrowed to $6.1 billion to $6.3 billion, and reflects persisting foreign currency headwinds | ||
| Adjusted EBITDA margin range now 32%-34% to incorporate acquired IPR&D and milestone expenses from recent business development |
Jersey City, N.J., August 4, 2022 - Organon (NYSE: OGN)
(the "company"), today announced its results for the second quarter ended June 30, 2022.
"During the second quarter, Organon delivered constant currency
growth across all our reported geographies and in all three franchises. Our Established Brands franchise grew in almost every therapy
area, demonstrating the sustainability and untapped potential of these brands," said Kevin Ali, Organon's Chief Executive Officer.
"Additionally, we continued to invest for growth during the quarter adding Shanghai Henlius Biotech as another R&D and manufacturing
collaborator for biosimilars, underscoring our commitment to this business. And importantly, we further expanded our offerings in Women's
Health recently signing a research collaboration with Cirqle Biomedical for a novel investigational non-hormonal, on-demand contraceptive
Second quarter 2022 revenues
| in $ millions | Q2 2022 | Q2 2021 | VPY | VPY ex-FX | ||||||||||||
| Women's Health | $ | 408 | $ | 417 | (2 | )% | 1 | % | ||||||||
| Biosimilars | 119 | 86 | 39 | % | 42 | % | ||||||||||
| Established Brands | 1,018 | 1,045 | (2 | )% | 4 | % | ||||||||||
| Other (1) | 40 | 47 | (17 | )% | (18 | )% | ||||||||||
| Revenues | $ | 1,585 | $ | 1,595 | (1 | )% | 5 | % |
includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin
revenue hedging activities.
Total net revenues were $1,585 million for the second quarter of 2022,
a decrease of 1% as-reported and an increase of 5% excluding the impact of foreign currency (ex-FX), compared with the second quarter
Women's Health declined 2% as-reported, but increased 1% ex-FX
in the second quarter of 2022 compared with the second quarter of 2021. During the second quarter of 2022, Nexplanon (etonogestrel
implant) grew 8% ex-FX, primarily driven by favorable pricing and demand uptake in the United States and volume growth outside the United
States. Nuvaring (etonogestrel/ethinyl estradiol vaginal ring) continues to be impacted by generic competition and declined
18% ex-FX in the second quarter of 2022 compared with the prior year period. Follistim AQ (follitropin beta injection), declined
9% ex-FX in the second quarter of 2022, primarily due to COVID-related disruptions in China and an unfavorable channel mix in the United
States, that offset solid demand.
Biosimilars revenue grew 39% as-reported and 42% ex-FX in the second
quarter 2022 compared with the second quarter of 2021. Organon's current portfolio includes certain immunology and oncology treatments.
All five of the biosimilars in Organon's portfolio have launched in certain countries globally, including two biosimilars, Renflexis
(infliximab-abda) and Ontruzant (trastuzumab-dttb), in the United States. Renflexis grew 39% ex-FX in the second quarter
of 2022 compared with the prior year period, primarily due to continued demand growth in the United States since its launch in 2017. Ontruzant
grew 61% ex-FX driven by timing of an order in Brazil, as well as continued uptake in the United States since its launch in July 2020,
partially offset by increased competition in Europe.
Established Brands represents a broad portfolio of well-known medicines,
which are generally beyond market exclusivity, including leading brands in cardiovascular, respiratory, dermatology and non-opioid pain
management, and for which generic competition varies by market. The portfolio's exposure to loss of exclusivity (LOE) risk peaked in 2021
and no longer represents a significant impediment to stable performance in the Established Brands franchise. Revenues for Established
Brands decreased 2% as-reported and increased 4% ex-FX in the second quarter of 2022 compared with the second quarter of 2021. During
the second quarter of 2022, the cardiovascular portfolio grew 3% ex-FX primarily driven by strong Atozet TM (ezetimibe and
atorvastatin calcium) sales in Europe and Cozaar (losartan potassium) /Hyzaar (losartan potassium and hydrochlorothiazide) sales
in China. The Established Brands franchise also benefited from a continuation of a temporary supply disruption affecting several competitors
in the Japanese market, most notably in the respiratory portfolio. Year to date, the franchise has not experienced significant impacts
from the implementation of Volume Based Procurement (VBP) in China, which the company expects will be more pronounced in the second half
of 2022. Still, based on the strong year to date performance, the company expects the Established Brands franchise to deliver relatively
flat constant currency revenue growth for the full year 2022.
Second quarter 2022 profitability
Organon was spun-off from Merck & Co., Inc., Rahway,
NJ, USA on June 2, 2021. Financial results during the pre-spin period were presented on the carve-out basis of accounting and do
not purport to reflect what Organon's financial results would have been had Organon operated as a standalone public company. Therefore,
with the exception of revenue, financial results for the periods ending June 30, 2022 and June 30, 2021 are not meaningfully
| in $ millions, except per share amounts | Q2 2022 | Q2 2021 mid-year spin | VPY | |||||||||
| Revenues | $ | 1,585 | $ | 1,595 | (1 | )% | ||||||
| Gross profit | 997 | 1,012 | (1 | )% | ||||||||
| Non-GAAP Adjusted Gross Profit (1) | 1,047 | 1,047 | - | % | ||||||||
| Adjusted EBITDA (1,2) | 512 | 627 | (18 | )% | ||||||||
| Net Income, continuing operations | 234 | 431 | (46 | )% | ||||||||
| Non-GAAP adjusted net income, continuing operations (1) | 319 | 437 | (27 | )% | ||||||||
| Diluted Earnings per Share (EPS), continuing operations | 0.92 | 1.70 | (46 | )% | ||||||||
| Non-GAAP adjusted diluted EPS, continuing operations (1) | 1.25 | 1.72 | (27 | )% | ||||||||
| Acquired IPR&D and milestones | 97 | - | NM | |||||||||
| Per share impact to diluted EPS from acquired IPR&D and milestones | (0.30 | ) | - | NM |
| Q2 2022 | Q2 2021 mid-year spin | |||||||||||
| Gross margin | 62.9 | % | 63.4 | % | ||||||||
| Non-GAAP Adjusted Gross Margin (1) | 66.1 | % | 65.6 | % | ||||||||
| Adjusted EBITDA margin (1,2) | 32.3 | % | 39.3 | % |
Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP financial measures
EBITDA and Adjusted EBITDA margin include $97 million in the second quarter of 2022 related to acquired IPR&D and milestones
Gross margin in the second quarter of 2022 was 62.9% as-reported, and
comparable to 63.4% in the prior year period. Adjusted Gross Margin was 66.1% in the second quarter of 2022 compared with 65.6% on an
adjusted basis in the second quarter of 2021.
Adjusted EBITDA margin was 32.3% in the second quarter of 2022 compared
with 39.3% in the second quarter of 2021. Adjusted EBITDA margin in the second quarter of 2022 is inclusive of $97 million of acquired
IPR&D and milestones. Higher R&D spend associated with the company's recent acquisitions of clinical stage assets as well as higher
employee related costs contributed to the decline in Adjusted EBITDA margin year over year.
Net income from continuing operations for the second quarter of 2022
was $234 million, or $0.92 per diluted share, compared with $431 million, or $1.70 per diluted share, in the second quarter of 2021. Non-GAAP
Adjusted net income from continuing operations was $319 million, or $1.25 per diluted share, compared with $437 million, or $1.72 per
diluted share, in 2021.
Beginning in 2022, Organon will no longer exclude expenses for upfront
and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions
accounted for as asset acquisitions from its non-GAAP results. The change to include all acquired IPR&D and milestone expenses negatively
impacted Adjusted diluted EPS by $0.30 in the second quarter of 2022. There was no similar impact in the second quarter of 2021. In connection
with this change, acquired IPR&D expenses are now reported as a separate income statement line item. These costs were previously recorded
within the R&D expenses line. Prior period amounts have been revised to conform to the current period presentation.
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 September 15,
2022 to stockholders of record at the close of business on August 15, 2022.
As of June 30, 2022, cash and cash equivalents were $545 million,
and debt was $8.9 billion. Total debt as of June 30, 2022 reflects a discretionary second quarter prepayment of $100 million on the
company's U.S. dollar denominated term loan.
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.
The company is updating its full year 2022 guidance ranges previously
provided on May 5, 2022. The range for full year 2022 revenue is narrowed to $6.1 billion to $6.3 billion, which reflects persisting
foreign exchange headwinds. The range for full year Adjusted EBITDA margin is now 32% to 34% to incorporate approximately $110 million
of IPR&D and milestone expenses from business development through August 4, 2022. Organon's financial guidance does not assume
an estimate for future IPR&D and milestone payments for business development transactions not yet executed.
| Previous guidance | FX impact | IPR&D | Current guidance | |||||
| Revenues | $6.1B - $6.4B | From 300-475 bps to 550-650 bps | $6.1B - $6.3B | |||||
| Adjusted Gross margin | Mid 60% | Unchanged | ||||||
| SG&A (as % of revenue) | Mid 20% | Unchanged | ||||||
| R&D (as % of revenue) | Mid-upper single digit | Upper single-digit | ||||||
| Adjusted EBITDA margin | 34%-36% | ~($110)M | 32% - 34% | |||||
| Interest | ~$400 million | Unchanged | ||||||
| Depreciation | $100-$115 million | Unchanged | ||||||
| Effective Non-GAAP tax rate | 17.5%-19.5% | Unchanged | ||||||
| Fully diluted weighted avg. shares outstanding | ~255 million | Unchanged |
host a conference call at 8:30 a.m. Eastern Time today to discuss its second quarter 2022 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/.
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 using conference ID# 58511-993
and by clicking on this link: https://conferencingportals.com/event/ZGyfDfjk. 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.
Organon is a global healthcare company formed to focus on improving
the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic
areas. Led by the women's health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines,
Organon's products produce strong cash flows that will support investments in innovation and future growth opportunities in women's
health. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their
products by leveraging its scale and presence in fast growing international markets.
Organon has a global footprint with significant scale and geographic