First quarter 2022 revenue of $1,567 million
Net income from continuing operations of $348 million, or $1.36 per diluted share; Adjusted net income from continuing operations of $420 million, or $1.65 per diluted share
Adjusted EBITDA of $647 million
Board of Directors declares quarterly dividend of $0.28 per share
Full year 2022 financial guidance ranges affirmed
JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) (the “company”), today announced its results for the first quarter ended March 31, 2022.
"The first quarter marked a solid start to the year. We continued to expand our Women's Health offerings by acquiring the rights to Marvelon™ (ethinylestradiol, desogestrel) and Mercilon™ (ethinylestradiol, desogestrel) in certain markets, as well as by entering into a licensing agreement to commercialize XaciatoTM (clindamycin phosphate) vaginal gel," said Kevin Ali, Organon's CEO. "Additionally, with LOE risk in the Established Brands business largely behind us, together with continued focus on maximizing the potential of these well-known brands, we are starting to see the stability we knew was possible in that franchise."
First quarter 2022 revenue |
||||||||||||
in $ millions |
|
Q1 2022 |
|
Q1 2021 |
|
VPY |
|
VPY ex-FX |
||||
Women’s Health |
|
$ |
378 |
|
$ |
399 |
|
(5)% |
|
(3)% |
||
Biosimilars |
|
|
99 |
|
|
81 |
|
22% |
|
25% |
||
Established Brands |
|
|
1,053 |
|
|
957 |
|
10% |
|
15% |
||
Other (1) |
|
|
37 |
|
|
69 |
|
(45)% |
|
(46)% |
||
Revenue |
|
$ |
1,567 |
|
$ |
1,506 |
|
4% |
|
8% |
(1) Other 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 revenue was $1,567 million for the first quarter of 2022, an increase of 4% as-reported and an increase of 8% excluding the impacts of foreign currency (ex-FX), compared with the first quarter of 2021.
Women’s Health declined 5% as-reported and declined 3% ex-FX in the first quarter 2022 compared with the first quarter of 2021, driven by Nuvaring® (etonogestrel/ethinyl estradiol vaginal ring) which declined 6% ex-FX in the first quarter of 2022 compared with the first quarter of 2021, and the Authorized Generic of Nuvaring (AG), both of which continue to be impacted by generic competition. The decline in the Women's Health portfolio was also due to a 5% ex-FX decline in Nexplanon® (etonogestrel implant) which was driven by distributors' buying patterns in the United States in prior periods, partially offset by strong performance in Latin America and volume growth in Europe. The decline in the company's contraception portfolio was partially offset by double digit growth in the fertility franchise, led by Follistim AQ® (follitropin beta injection), which grew 20% ex-FX, primarily due to higher demand in China and volume growth in the United States.
Biosimilars revenue grew 22% as-reported and grew 25% ex-FX in the first quarter 2022 compared with first quarter 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 21% ex-FX in the first quarter of 2022 compared with the first quarter of 2021 primarily due to continued demand growth in the United States since its launch in 2017. Ontruzant grew 5% ex-FX driven by continued uptake in the United States since its launch in July 2020, partially offset by competitive pressures 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. Revenue for Established Brands increased 10% as-reported and increased 15% ex-FX in the first quarter of 2022 compared with the first quarter of 2021. The first quarter of 2022 benefited from fluctuations in demand in certain markets, including a temporary supply issue currently impacting several competitors in the Japanese market. This compares to weaker performance in Japan in the first quarter of 2021 due to anticipated government-led price actions in that market and lingering effects from the LOE of Zetia® (ezetimibe). Additionally, the first quarter of last year was negatively impacted by the implementation of the third round of Volume Based Procurement (VBP) initiatives in China, as well as by LOE exposure. There was minimal impact from these factors in the first quarter of 2022. Volume growth in products in China, Europe and the LAMERA region also contributed to the favorable performance of Established Brands in the first quarter of 2022.
First 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 March 31, 2021 and March 31, 2022 are not meaningfully comparable.
in $ millions, except per share amounts |
|
Q1 2022 |
|
Q1 2021
|
|
VPY |
||||
Revenue |
|
$ |
1,567 |
|
$ |
1,506 |
|
4% |
||
Cost of sales |
|
|
561 |
|
|
591 |
|
(5)% |
||
Gross profit |
|
|
1,006 |
|
|
915 |
|
10% |
||
Non-GAAP Adjusted gross profit (*) |
|
|
1,042 |
|
|
937 |
|
11% |
||
Adjusted EBITDA (*) |
|
|
647 |
|
|
566 |
|
14% |
||
Net Income, continuing operations (*) |
|
|
348 |
|
|
395 |
|
(12)% |
||
Non-GAAP Adjusted net income, continuing operations (*) |
|
|
420 |
|
|
451 |
|
(7)% |
||
Diluted Earnings per Share, continuing operations |
|
|
1.36 |
|
|
1.56 |
|
(13)% |
||
Non-GAAP Adjusted Diluted Earnings per Share, continuing operations (*) |
|
|
1.65 |
|
|
1.78 |
|
(7)% |
Gross margin |
|
64.2% |
|
60.8 % |
|
Non-GAAP adjusted gross margin (*) |
|
66.5% |
|
62.2 % |
|
Adjusted EBITDA margin (*) |
|
41.3% |
|
37.6 % |
|
(*) See Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP financial measures |
Gross margin was 64.2% as-reported and 66.5% on an adjusted basis in the first quarter of 2022 compared with 60.8% as-reported and 62.2% on an adjusted basis in the first quarter of 2021. The year-over-year improvement in gross margin primarily reflects reduced lower margin supply sales in the first quarter of this year.
Adjusted EBITDA margin was 41.3% in the first quarter of 2022 compared with 37.6% in the first quarter of 2021. The improvement in Adjusted EBITDA margin is largely driven by higher Adjusted gross profit in the period, and also reflects lower SG&A costs compared with the prior year, pre-spin period, partially offset by increased research and development costs in the first quarter of 2022 associated with the company's recent acquisitions of clinical stage assets. Adjusted EBITDA margin in the first quarter of 2022 incorporates SG&A costs that are expected to be at the lowest point for full year 2022.
Net income from continuing operations for the first quarter of 2022 was $348 million, or $1.36 per diluted share, compared with $395 million, or $1.56 per diluted share, in the first quarter of 2021. Non-GAAP Adjusted net income from continuing operations was $420 million, or $1.65 per diluted share, compared with $451 million, or $1.78 per diluted share, in 2021.
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 June 16, 2022 to stockholders of record at the close of business on May 16, 2022.
As of March 31, 2022, cash and cash equivalents were $694 million, and debt was $9,094 million, resulting in net debt of $8,400 million.
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.
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. These changes are being made to align with views expressed by the U.S. Securities and Exchange Commission. There are no such expenses or charges for in-process research and development for the periods ended March 31, 2022 or March 31, 2021. Relevant prior periods have been recast to reflect these changes and can be found in Tables 7 and 8 of this press release.
Organon's financial guidance does not assume an estimate for future in-process research and development for business development transactions not yet executed.
The company affirmed the full year 2022 financial guidance previously provided on February 17, 2022, which is presented on a non-GAAP basis.
|
|
Previous guidance |
|
Current guidance |
Revenue |
|
$6.1B - $6.4B |
|
Unchanged |
Adjusted gross margin |
|
Mid 60% |
|
Unchanged |
SG&A as % of revenue |
|
Mid 20% |
|
Unchanged |
R&D as % of revenue |
|
Mid to upper single digit |
|
Unchanged |
Adjusted EBITDA margin |
|
34%-36% |
|
Unchanged |
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 |
Webcast Information
Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its first 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# 6895016 and by clicking on this link: http://www.directeventreg.com/registration/event/6895016. 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 through a spin-off from Merck & Co., Inc., Rahway, NJ, USA (NYSE: MRK) 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 reach, world-class commercial capabilities, and approximately 9,300 employees with headquarters located in Jersey City, New Jersey.
For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.
Non-GAAP financial measures
This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are 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 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. 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. You should refer to the appendix of this press release for 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 2022 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 and other items not reflective of the company's ongoing operations.
The company uses non-GAAP financial measures in its operational and financial decision making, and believes that it is useful to exclude certain items in order to focus on what it regards to be a more meaningful representation of the underlying operating performance of the business.
Forward-Looking Statement
Except for historical information herein, 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. Forward-looking statements may be identified by words such as “expects,” “intends,” “anticipates,” “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, an inability to execute on our business development strategy or realize the benefits of our planned acquisitions; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
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 Annual Report on Form 10-K for the year ended December 31, 2021 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 share and per share amounts) |
|||||||
|
Three Months Ended March 31, |
||||||
|
2022 |
|
|
2021 |
|
||
Revenues |
$ |
1,567 |
|
$ |
1,506 |
|
|
Costs, Expenses and Other |
|
|
|
||||
Cost of sales |
|
561 |
|
|
591 |
|
|
Selling, general and administrative |
|
371 |
|
|
382 |
|
|
Research and development |
|
96 |
|
|
67 |
|
|
Restructuring costs |
|
— |
|
|
1 |
|
|
Other (income) expense, net |
|
97 |
|
|
(2 |
) |
|
|
|
1,125 |
|
|
1,039 |
|
|
Income From Continuing Operations Before Income Taxes |
|
442 |
|
|
467 |
|
|
Taxes on Income |
|
94 |
|
|
72 |
|
|
Net Income From Continuing Operations |
|
348 |
|
|
395 |
|
|
Income From Discontinued Operations - Net of Tax |
|
— |
|
|
4 |
|
|
Net Income |
|
348 |
|
|
399 |
|
|
Earnings per Share Attributable to Organon & Co. Stockholders - Basic: |
|
|
|
||||
Continuing operations |
$ |
1.37 |
|
$ |
1.56 |
|
|
Discontinued operations |
|
— |
|
|
0.02 |
|
|
Net Earnings per Share Attributable to Organon & Co. Stockholders |
$ |
1.37 |
|
$ |
1.58 |
|
|
Earnings per Share Attributable to Organon & Co. Stockholders - Diluted: |
|
|
|
||||
Continuing operations |
$ |
1.36 |
|
$ |
1.56 |
|
|
Discontinued operations |
|
— |
|
|
0.02 |
|
|
Net Earnings per Share Attributable to Organon & Co. Stockholders |
$ |
1.36 |
|
$ |
1.58 |
|
|
Weighted Average Shares Outstanding: |
|
|
|
||||
Basic |
|
253,583,000 |
|
|
253,516,000 |
|
|
Diluted |
|
255,052,000 |
|
|
253,516,000 |
|
TABLE 2 |
|||||||||||||||||||||||
Organon & Co. Sales by top products |
|||||||||||||||||||||||
|
Three Months Ended March 31, |
||||||||||||||||||||||
|
2022 |
|
2021 |
||||||||||||||||||||
($ in millions) |
U.S. |
|
Int’l |
|
Total |
|
U.S. |
|
Int’l |
|
Total |
||||||||||||
Women’s Health |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Nexplanon/Implanon NXT |
$ |
116 |
|
$ |
55 |
|
$ |
171 |
|
$ |
141 |
|
|
$ |
42 |
|
$ |
183 |
|||||
Follistim AQ |
|
30 |
|
|
31 |
|
|
61 |
|
|
25 |
|
|
|
27 |
|
|
52 |
|||||
NuvaRing |
|
16 |
|
|
24 |
|
|
41 |
|
|
21 |
|
|
|
24 |
|
|
45 |
|||||
Ganirelix Acetate Injection |
|
8 |
|
|
22 |
|
|
30 |
|
|
8 |
|
|
|
21 |
|
|
29 |
|||||
Cerazette |
|
— |
|
|
18 |
|
|
18 |
|
|
— |
|
|
|
17 |
|
|
17 |
|||||
Other Women's Health (1) |
|
27 |
|
|
31 |
|
|
57 |
|
|
40 |
|
|
|
33 |
|
|
73 |
|||||
Biosimilars |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Renflexis |
|
42 |
|
|
4 |
|
|
46 |
|
|
35 |
|
|
|
4 |
|
|
38 |
|||||
Ontruzant |
|
7 |
|
|
15 |
|
|
22 |
|
|
4 |
|
|
|
19 |
|
|
22 |
|||||
Brenzys |
|
— |
|
|
14 |
|
|
14 |
|
|
— |
|
|
|
10 |
|
|
10 |
|||||
Aybintio |
|
— |
|
|
10 |
|
|
10 |
|
|
— |
|
|
|
8 |
|
|
8 |
|||||
Hadlima |
|
— |
|
|
6 |
|
|
6 |
|
|
— |
|
|
|
2 |
|
|
2 |
|||||
Established Brands |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Zetia |
|
3 |
|
|
96 |
|
|
99 |
|
|
2 |
|
|
|
89 |
|
|
92 |
|||||
Vytorin |
|
2 |
|
|
36 |
|
|
38 |
|
|
3 |
|
|
|
38 |
|
|
41 |
|||||
Atozet |
|
— |
|
|
119 |
|
|
119 |
|
|
— |
|
|
|
112 |
|
|
112 |
|||||
Rosuzet |
|
— |
|
|
22 |
|
|
22 |
|
|
— |
|
|
|
15 |
|
|
15 |
|||||
Cozaar/Hyzaar |
|
8 |
|
|
86 |
|
|
93 |
|
|
3 |
|
|
|
87 |
|
|
90 |
|||||
Other Cardiovascular (1) |
|
1 |
|
|
38 |
|
|
39 |
|
|
1 |
|
|
|
38 |
|
|
39 |
|||||
Respiratory |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Singulair |
|
3 |
|
|
127 |
|
|
130 |
|
|
5 |
|
|
|
102 |
|
|
107 |
|||||
Nasonex |
|
9 |
|
|
65 |
|
|
75 |
|
|
2 |
|
|
|
41 |
|
|
43 |
|||||
Dulera |
|
31 |
|
|
9 |
|
|
40 |
|
|
31 |
|
|
|
8 |
|
|
38 |
|||||
Clarinex |
|
1 |
|
|
37 |
|
|
38 |
|
|
1 |
|
|
|
23 |
|
|
25 |
|||||
Other Respiratory (1) |
|
12 |
|
|
11 |
|
|
22 |
|
|
16 |
|
|
|
6 |
|
|
23 |
|||||
Non-Opioid Pain, Bone and Dermatology |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Arcoxia |
|
— |
|
|
60 |
|
|
60 |
|
|
— |
|
|
|
56 |
|
|
56 |
|||||
Fosamax |
|
1 |
|
|
40 |
|
|
41 |
|
|
1 |
|
|
|
37 |
|
|
38 |
|||||
Diprospan |
|
— |
|
|
31 |
|
|
31 |
|
|
— |
|
|
|
26 |
|
|
26 |
|||||
Other Non-Opioid Pain, Bone and Dermatology (1) |
|
3 |
|
|
66 |
|
|
69 |
|
|
(1 |
) |
|
|
62 |
|
|
61 |
|||||
Other |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Proscar |
|
— |
|
|
24 |
|
|
24 |
|
|
— |
|
|
|
32 |
|
|
32 |
|||||
Propecia |
|
1 |
|
|
29 |
|
|
30 |
|
|
2 |
|
|
|
29 |
|
|
31 |
|||||
Other (1) |
|
8 |
|
|
74 |
|
|
83 |
|
|
11 |
|
|
|
78 |
|
|
89 |
|||||
Other (2) |
|
— |
|
|
37 |
|
|
37 |
|
|
— |
|
|
|
69 |
|
|
69 |
|||||
Total Revenue |
$ |
329 |
|
$ |
1,238 |
|
$ |
1,567 |
|
$ |
351 |
|
|
$ |
1,155 |
$ |
1,506 |
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) |
Includes sales of products not listed separately. Revenue from an arrangement for the sale of generic etonogestrel/ethinyl estradiol vaginal ring is included in Other Women's Health. | |
(2) |
Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities. |
TABLE 3 |
|||||||
Organon & Co. Sales by geographic area (Unaudited, $ in millions) |
|||||||
|
Three Months Ended March 31, |
||||||
($ in millions) |
2022 |
|
2021 |
||||
Europe and Canada |
$ |
436 |
|
$ |
434 |
||
United States |
|
329 |
|
|
351 |
||
Asia Pacific and Japan |
|
314 |
|
|
278 |
||
China |
|
236 |
|
|
206 |
||
Latin America, Middle East, Russia and Africa |
|
209 |
|
|
167 |
||
Other (1) |
|
43 |
|
|
70 |
||
Revenue |
$ |
1,567 |
|
$ |
1,506 |
(1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities. |
TABLE 4 |
|||||||
Reconciliation of GAAP Gross Margin to Non-GAAP Adjusted Gross Profit and Adjusted Gross Margin ($ in millions) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2022 |
|
|
|
2021 |
|
Revenue |
$ |
1,567 |
|
|
$ |
1,506 |
|
Cost of sales |
|
561 |
|
|
|
591 |
|
Gross Profit |
|
1,006 |
|
|
|
915 |
|
Gross Margin |
|
64.2 |
% |
|
|
60.8 |
% |
Amortization |
|
28 |
|
|
|
20 |
|
One-time costs (1) |
|
5 |
|
|
|
— |
|
Stock-based compensation |
|
3 |
|
|
|
2 |
|
Non-GAAP Adjusted Gross Profit (2) |
$ |
1,042 |
|
|
$ |
937 |
|
Non-GAAP Adjusted Gross Margin |
|
66.5 |
% |
|
|
62.2 |
% |
(1) One-time costs for the three months ended March 31, 2022 primarily include costs to stand up the Company. |
(2) Non-GAAP Adjusted Gross Profit is calculated by excluding amortization, one-time costs, and the portion of stock-based compensation expense allocated to Cost of sales. |
TABLE 5 |
|||||||
Organon & Co. Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Adjusted EBITDA ($ in millions) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2022 |
|
|
|
2021 |
|
Income from continuing operations before income taxes |
$ |
442 |
|
|
$ |
467 |
|
Depreciation |
|
25 |
|
|
|
18 |
|
Amortization (1) |
|
28 |
|
|
|
20 |
|
Interest expense |
|
97 |
|
|
|
— |
|
EBITDA |
|
592 |
|
|
|
505 |
|
Restructuring costs |
|
— |
|
|
|
1 |
|
One-time costs (2) |
|
40 |
|
|
|
49 |
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
Stock-based compensation |
|
15 |
|
|
|
11 |
|
Adjusted EBITDA |
$ |
647 |
|
|
$ |
566 |
|
Adjusted EBITDA margin |
|
41.3 |
% |
|
|
37.6 |
% |
(1) Amortization in all periods is included in Cost of sales. |
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon. For the three months ended March 31, 2022, approximately $25 million of the one-time costs are recorded in Selling, general and administrative expenses, $6 million are recorded in Other (income) expense, $5 million are recorded in Cost of sales, and $4 million are recorded in Research and development. For the three months ended March 31, 2021, $49 million of the one-time costs are classified in Selling, general and administrative expenses. |
TABLE 6 |
|||||||
Organon & Co. Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Non-GAAP Adjusted Net Income ($ in millions, except per share amounts) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2022 |
|
|
|
2021 |
|
Income from continuing operations before income taxes |
$ |
442 |
|
|
$ |
467 |
|
Adjustments: |
|
|
|
||||
Amortization (1) |
|
28 |
|
|
|
20 |
|
Restructuring costs |
|
— |
|
|
|
1 |
|
One-time costs (2) |
|
40 |
|
|
|
49 |
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
Stock-based compensation |
|
15 |
|
|
|
11 |
|
Total Adjustments |
|
83 |
|
|
|
81 |
|
Non-GAAP pre-tax income from continuing operations |
|
525 |
|
|
|
548 |
|
Taxes on income as reported in accordance with GAAP |
|
94 |
|
|
|
72 |
|
Tax benefit on adjustments |
|
14 |
|
|
|
15 |
|
Tax (deduction)/benefit on GAAP-only discrete items |
|
(3 |
) |
|
|
10 |
|
Non-GAAP adjusted taxes on income |
|
105 |
|
|
|
97 |
|
Non-GAAP adjusted net income, continuing operations |
|
420 |
|
|
|
451 |
|
Non-GAAP adjusted net income, continuing operations per diluted share |
$ |
1.65 |
|
|
$ |
1.78 |
(1) Amortization in all periods is included in Cost of sales. |
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon. For the three months ended March 31, 2022, approximately $25 million of the one-time costs are recorded in Selling, general and administrative expenses, $6 million are recorded in Other (income) expense, $5 million are recorded in Cost of sales, and $4 million are recorded in Research and development. For the three months ended March 31, 2021, $49 million of the one-time costs are classified in Selling, general and administrative expenses. |
TABLE 7 |
|||||||||||||||||||||||||||||||||||
Organon & Co. |
|||||||||||||||||||||||||||||||||||
Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Adjusted EBITDA |
|||||||||||||||||||||||||||||||||||
($ in millions) |
|||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
Q1 2021 |
|
Q2 2021 |
|
Q3 2021 |
|
Q4 2021 |
|
FY 2021 |
||||||||||||||||||||||||||
|
As
|
|
As
|
|
As
|
|
Impact of
|
|
Recast |
|
As
|
|
Impact of
|
|
Recast |
|
As
|
|
Impact of
|
|
Recast |
||||||||||||||
Income from continuing operations before income taxes |
$ |
467 |
|
$ |
437 |
|
$ |
389 |
|
$ |
— |
|
|
$ |
389 |
|
$ |
236 |
|
$ |
— |
|
|
$ |
236 |
|
$ |
1,529 |
|
$ |
— |
|
|
$ |
1,529 |
Depreciation |
|
18 |
|
|
21 |
|
|
25 |
|
|
— |
|
|
|
25 |
|
|
28 |
|
|
— |
|
|
|
28 |
|
|
92 |
|
|
— |
|
|
|
92 |
Amortization (1) |
|
20 |
|
|
22 |
|
|
27 |
|
|
— |
|
|
|
27 |
|
|
34 |
|
|
— |
|
|
|
34 |
|
|
103 |
|
|
— |
|
|
|
103 |
Interest expense |
|
— |
|
|
62 |
|
|
98 |
|
|
— |
|
|
|
98 |
|
|
98 |
|
|
— |
|
|
|
98 |
|
|
258 |
|
|
— |
|
|
|
258 |
EBITDA |
$ |
505 |
|
$ |
542 |
|
$ |
539 |
|
$ |
— |
|
|
$ |
539 |
|
$ |
396 |
|
$ |
— |
|
|
$ |
396 |
|
$ |
1,982 |
|
$ |
— |
|
|
$ |
1,982 |
Restructuring costs |
|
1 |
|
|
1 |
|
|
1 |
|
|
— |
|
|
|
1 |
|
|
— |
|
|
— |
|
|
|
— |
|
|
3 |
|
|
— |
|
|
|
3 |
One-time costs (2) |
|
49 |
|
|
66 |
|
|
56 |
|
|
— |
|
|
|
56 |
|
|
59 |
|
|
— |
|
|
|
59 |
|
|
231 |
|
|
— |
|
|
|
231 |
Acquired in-process research and development (3) |
|
— |
|
|
— |
|
|
25 |
|
|
(25 |
) |
|
|
— |
|
|
79 |
|
|
(79 |
) |
|
|
— |
|
|
104 |
|
|
(104 |
) |
|
|
— |
Stock-based compensation |
|
11 |
|
|
18 |
|
|
15 |
|
|
— |
|
|
|
15 |
|
|
15 |
|
|
— |
|
|
|
15 |
|
|
59 |
|
|
— |
|
|
|
59 |
Adjusted EBITDA |
$ |
566 |
|
$ |
627 |
|
$ |
636 |
|
$ |
(25 |
) |
|
$ |
611 |
|
$ |
549 |
|
$ |
(79 |
) |
|
$ |
470 |
|
$ |
2,379 |
|
$ |
(104 |
) |
|
$ |
2,275 |
(1) Amortization in all periods is included in Cost of sales. |
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon as well as acquisition related costs. Refer to the Company's previously filed Current Reports on Form 8-K for a further description of these costs for each reported period. |
(3) Costs represent upfront licensing payment associated with ObsEva of $25 million during the third quarter of 2021 and Forendo of $79 million in the fourth quarter of 2021, which were recorded in Research and development expense. |
(4) The change does not affect the previously reported Adjusted EBITDA results for the first and second quarter of 2021 as there were no adjustments which affected either of the periods. |
TABLE 8 |
|||||||||||||||||||||||||||||||||||
Organon & Co. |
|||||||||||||||||||||||||||||||||||
Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Non-GAAP Adjusted Net Income |
|||||||||||||||||||||||||||||||||||
($ in millions, except per share amounts) |
|||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
Q1 2021 |
|
Q2 2021 |
|
Q3 2021 |
|
Q4 2021 |
|
FY 2021 |
||||||||||||||||||||||||||
|
As
|
|
As
|
|
As
|
|
Impact of
|
|
Recast |
|
As
|
|
Impact of
|
|
Recast |
|
As
|
|
Impact of
|
|
Recast |
||||||||||||||
Income from continuing operations before income taxes |
$ |
467 |
|
$ |
437 |
|
$ |
389 |
|
$ |
— |
|
|
$ |
389 |
|
$ |
236 |
|
$ |
— |
|
|
$ |
236 |
|
$ |
1,529 |
|
$ |
— |
|
|
$ |
1,529 |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Amortization (1) |
|
20 |
|
|
22 |
|
|
27 |
|
|
— |
|
|
|
27 |
|
|
34 |
|
|
— |
|
|
|
34 |
|
|
103 |
|
|
— |
|
|
|
103 |
Restructuring costs |
|
1 |
|
|
1 |
|
|
1 |
|
|
— |
|
|
|
1 |
|
|
— |
|
|
— |
|
|
|
— |
|
|
3 |
|
|
— |
|
|
|
3 |
One-time costs (2) |
|
49 |
|
|
66 |
|
|
56 |
|
|
— |
|
|
|
56 |
|
|
59 |
|
|
— |
|
|
|
59 |
|
|
231 |
|
|
— |
|
|
|
231 |
Acquired in-process research and development (3) |
|
— |
|
|
— |
|
|
25 |
|
|
(25 |
) |
|
|
— |
|
|
79 |
|
|
(79 |
) |
|
|
— |
|
|
104 |
|
|
(104 |
) |
|
|
— |
Stock-based compensation |
|
11 |
|
|
18 |
|
|
15 |
|
|
— |
|
|
|
15 |
|
|
15 |
|
|
— |
|
|
|
15 |
|
|
59 |
|
|
— |
|
|
|
59 |
Total Adjustments |
|
81 |
|
|
107 |
|
|
124 |
|
|
(25 |
) |
|
|
99 |
|
|
187 |
|
|
(79 |
) |
|
|
108 |
|
|
500 |
|
|
(104 |
) |
|
|
396 |
Non-GAAP pre-tax income from continuing operations |
$ |
548 |
|
$ |
544 |
|
$ |
513 |
|
$ |
(25 |
) |
|
$ |
488 |
|
$ |
423 |
|
$ |
(79 |
) |
|
$ |
344 |
|
$ |
2,029 |
|
$ |
(104 |
) |
|
$ |
1,925 |
Taxes on income as reported in accordance with GAAP |
|
72 |
|
|
6 |
|
|
66 |
|
|
— |
|
|
|
66 |
|
|
34 |
|
|
— |
|
|
|
34 |
|
|
178 |
|
|
— |
|
|
|
178 |
Tax benefit on adjustments |
|
15 |
|
|
20 |
|
|
23 |
|
|
(2 |
) |
|
|
21 |
|
|
35 |
|
|
(17 |
) |
|
|
18 |
|
|
93 |
|
|
(19 |
) |
|
|
74 |
Tax benefit on GAAP-only discrete items (4) |
|
10 |
|
|
81 |
|
|
— |
|
|
— |
|
|
|
— |
|
|
5 |
|
|
— |
|
|
|
5 |
|
|
96 |
|
|
— |
|
|
|
96 |
Non-GAAP adjusted taxes on income |
$ |
97 |
|
$ |
107 |
|
$ |
89 |
|
$ |
(2 |
) |
|
$ |
87 |
|
$ |
74 |
|
$ |
(17 |
) |
|
$ |
57 |
|
$ |
367 |
|
$ |
(19 |
) |
|
$ |
348 |
Non-GAAP adjusted net income, continuing operations |
$ |
451 |
|
$ |
437 |
|
$ |
424 |
|
$ |
(23 |
) |
|
$ |
401 |
|
$ |
349 |
|
$ |
(62 |
) |
|
$ |
287 |
|
$ |
1,662 |
|
$ |
(85 |
) |
|
$ |
1,577 |
Non-GAAP adjusted net income from continuing operations per diluted share |
$ |
1.78 |
|
$ |
1.72 |
|
$ |
1.67 |
|
$ |
(0.09 |
) |
|
$ |
1.58 |
|
$ |
1.37 |
|
$ |
(0.24 |
) |
|
$ |
1.13 |
|
$ |
6.54 |
|
$ |
(0.33 |
) |
|
$ |
6.20 |
(1) Amortization in all periods is included in Cost of sales. |
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon as well as acquisition related costs. Refer to the Company's previously filed Form 8-Ks for a further description of these costs for each reported period. |
(3) Costs represent upfront licensing payment associated with ObsEva of $25 million during the third quarter of 2021 and Forendo of $79 million in the fourth quarter of 2021, which were recorded in Research and development expense. |
(4) Amounts include a tax benefit of approximately $70 million recorded in the second quarter of 2021 and a tax benefit of $5 million recorded in the fourth quarter of 2021 related to a portion of non-US step up in tax basis as a result of its separation from Merck & Co., Inc., Rahway, NJ, USA. |
(5) The change does not affect the previously reported Non-GAAP results for the first and second quarter of 2021 as there were no adjustments which affected either of the periods. |
Выручка за первый квартал 2022 года составила $1,567 млн.
Чистая прибыль от продолжающейся деятельности составила 348 миллионов долларов, или 1,36 доллара на разводненную акцию; Скорректированная чистая прибыль от продолжающейся деятельности составила 420 миллионов долларов, или 1,65 доллара на разводненную акцию
Скорректированная EBITDA составила 647 миллионов долларов
Совет директоров объявляет ежеквартальные дивиденды в размере 0,28 доллара на акцию
Подтверждены диапазоны финансовых ориентиров на весь 2022 год
ДЖЕРСИ-СИТИ, Нью-Джерси - (BUSINESS WIRE) -Organon (NYSE: OGN) (“компания”) сегодня объявила о своих результатах за первый квартал, закончившийся 31 марта 2022 года.
"Первый квартал ознаменовал уверенное начало года. Мы продолжили расширять наши предложения по охране здоровья женщин, приобретя права на Marvelon™ (этинилэстрадиол, дезогестрел) и Mercilon™ (этинилэстрадиол, дезогестрел) на определенных рынках, а также заключив лицензионное соглашение на коммерциализацию вагинального геля XaciatoTM (клиндамицин фосфат)", - сказал Кевин Али, генеральный директор Organon.. "Кроме того, поскольку риски LOE в бизнесе известных брендов в значительной степени позади, а также постоянное внимание к максимизации потенциала этих известных брендов, мы начинаем видеть стабильность, которая, как мы знали, была возможна в этой франшизе".
First quarter 2022 revenue |
||||||||||||
in $ millions |
|
Q1 2022 |
|
Q1 2021 |
|
VPY |
|
VPY ex-FX |
||||
Women’s Health |
|
$ |
378 |
|
$ |
399 |
|
(5)% |
|
(3)% |
||
Biosimilars |
|
|
99 |
|
|
81 |
|
22% |
|
25% |
||
Established Brands |
|
|
1,053 |
|
|
957 |
|
10% |
|
15% |
||
Other (1) |
|
|
37 |
|
|
69 |
|
(45)% |
|
(46)% |
||
Revenue |
|
$ |
1,567 |
|
$ |
1,506 |
|
4% |
|
8% |
(1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities. |
Общая чистая выручка за первый квартал 2022 года составила 1 567 миллионов долларов, увеличившись на 4% по сравнению с отчетным периодом и увеличившись на 8% без учета влияния иностранной валюты (ex-FX) по сравнению с первым кварталом 2021 года.
Состояние здоровья женщин снизилось на 5%, как сообщалось, и снизилось на 3% в первом квартале 2022 года по сравнению с первым кварталом 2021 года, что обусловлено Новарингом® (вагинальное кольцо с этоногестрелом /этинилэстрадиолом), которое снизилось на 6% в первом квартале 2022 года по сравнению с первым кварталом 2021 года. 2021 года и Авторизованный дженерик Nuvaring (AG), на оба из которых продолжает влиять конкуренция дженериков. Сокращение портфеля продуктов Women's Health также было вызвано 5%-ным снижением цены на Nexplanon® (имплантат этоногестрела) в пересчете на валюту, что было обусловлено покупательской деятельностью дистрибьюторов в Соединенных Штатах в предыдущие периоды, что частично компенсировалось высокими показателями в Латинской Америке и ростом объема продаж в Европе. Сокращение портфеля контрацептивов компании было частично компенсировано двузначным ростом франшизы fertility, возглавляемой Follistim AQ® (инъекция фоллитропина бета), которая выросла на 20% в пересчете на валюту, в первую очередь из-за более высокого спроса в Китае и роста объемов в Соединенных Штатах.
Выручка от биоаналогов выросла на 22%, как сообщалось, и выросла на 25% без учета иностранной валюты в первом квартале 2022 года по сравнению с первым кварталом 2021 года. Текущий портфель Organon включает в себя определенные методы лечения в области иммунологии и онкологии. Все пять биоаналогов из портфеля Organon были запущены в определенных странах по всему миру, в том числе два биоаналога, Renflexis® (инфликсимаб-abda) и Ontruzant® (трастузумаб-dttb), в Соединенных Штатах. Renflexis вырос на 21% без учета иностранной валюты в первом квартале 2022 года по сравнению с первым кварталом 2021 года, главным образом из-за продолжающегося роста спроса в Соединенных Штатах с момента его запуска в 2017 году. Ontruzant вырос на 5% без учета иностранной валюты благодаря продолжающемуся росту в Соединенных Штатах с момента его запуска в июле 2020 года, что частично компенсировалось конкурентным давлением в Европе.
Известные бренды представляют широкий ассортимент хорошо известных лекарств, которые, как правило, выходят за рамки эксклюзивности на рынке, включая ведущие бренды в области сердечно-сосудистой, респираторной, дерматологической и неопиоидной терапии боли, и конкуренция за которые варьируется в зависимости от рынка. Подверженность портфеля риску потери эксклюзивности (LOE) достигла своего пика в 2021 году и больше не представляет существенного препятствия для стабильной работы франшизы Известных брендов. Выручка Известных брендов увеличилась на 10% по сравнению с отчетным периодом и увеличилась на 15% без учета иностранной валюты в первом квартале 2022 года по сравнению с первым кварталом 2021 года. Первый квартал 2022 года выиграл от колебаний спроса на определенных рынках, включая временную проблему с поставками, которая в настоящее время затрагивает нескольких конкурентов на японском рынке. Это сопоставимо с более слабыми показателями в Японии в первом квартале 2021 года из-за ожидаемых действий правительства по снижению цен на этом рынке и сохраняющихся последствий снижения стоимости Zetia® (эзетимиба). Кроме того, на первый квартал прошлого года негативно повлияла реализация третьего раунда инициатив по объемным закупкам (VBP) в Китае, а также воздействие LOE. В первом квартале 2022 года влияние этих факторов было минимальным. Рост объемов продаж продукции в Китае, Европе и регионе ЛАМЕРА также способствовал благоприятным показателям известных брендов в первом квартале 2022 года.
Рентабельность за первый квартал 2022 года
Organon был выделен из Merck & Co., Inc., Рауэй, Нью-Джерси, США 2 июня 2021 года. Финансовые результаты за период до выпуска были представлены на основе бухгалтерского учета и не претендуют на то, чтобы отражать финансовые результаты Organon, которые были бы, если бы Organon работала как отдельная публичная компания. Таким образом, за исключением Выручки, финансовые результаты за периоды, закончившиеся 31 марта 2021 года и 31 марта 2022 года, не являются сопоставимыми по существу.
in $ millions, except per share amounts |
|
Q1 2022 |
|
Q1 2021
|
|
VPY |
||||
Revenue |
|
$ |
1,567 |
|
$ |
1,506 |
|
4% |
||
Cost of sales |
|
|
561 |
|
|
591 |
|
(5)% |
||
Gross profit |
|
|
1,006 |
|
|
915 |
|
10% |
||
Non-GAAP Adjusted gross profit (*) |
|
|
1,042 |
|
|
937 |
|
11% |
||
Adjusted EBITDA (*) |
|
|
647 |
|
|
566 |
|
14% |
||
Net Income, continuing operations (*) |
|
|
348 |
|
|
395 |
|
(12)% |
||
Non-GAAP Adjusted net income, continuing operations (*) |
|
|
420 |
|
|
451 |
|
(7)% |
||
Diluted Earnings per Share, continuing operations |
|
|
1.36 |
|
|
1.56 |
|
(13)% |
||
Non-GAAP Adjusted Diluted Earnings per Share, continuing operations (*) |
|
|
1.65 |
|
|
1.78 |
|
(7)% |
Gross margin |
|
64.2% |
|
60.8 % |
|
Non-GAAP adjusted gross margin (*) |
|
66.5% |
|
62.2 % |
|
Adjusted EBITDA margin (*) |
|
41.3% |
|
37.6 % |
|
(*) See Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP financial measures |
Валовая прибыль составила 64,2%, как сообщалось, и 66,5% на скорректированной основе в первом квартале 2022 года по сравнению с 60,8%, как сообщалось, и 62,2% на скорректированной основе в первом квартале 2021 года. Улучшение валовой прибыли по сравнению с предыдущим годом в первую очередь отражает снижение продаж с более низкой маржой в первом квартале этого года.
Скорректированная рентабельность по EBITDA составила 41,3% в первом квартале 2022 года по сравнению с 37,6% в первом квартале 2021 года. Улучшение скорректированной рентабельности по EBITDA в значительной степени обусловлено более высокой скорректированной валовой прибылью за отчетный период, а также отражает более низкие затраты на НИОКР по сравнению с предыдущим годом, периодом до запуска, частично компенсируемые увеличением затрат на исследования и разработки в первом квартале 2022 года, связанных с недавними приобретениями компанией клинических сценические активы. Скорректированная рентабельность по EBITDA в первом квартале 2022 года включает затраты на НИОКР, которые, как ожидается, будут на самом низком уровне за весь 2022 год.
Чистая прибыль от продолжающейся деятельности за первый квартал 2022 года составила 348 миллионов долларов, или 1,36 доллара на разводненную акцию, по сравнению с 395 миллионами долларов, или 1,56 доллара на разводненную акцию, в первом квартале 2021 года. Скорректированная без учета GAAP чистая прибыль от продолжающейся деятельности составила 420 миллионов долларов, или 1,65 доллара на разводненную акцию, по сравнению с 451 миллионом долларов, или 1,78 доллара на разводненную акцию, в 2021 году.
Распределение капитала
Сегодня Совет директоров Organon объявил о выплате ежеквартальных дивидендов в размере 0,28 доллара США за каждую выпущенную и находящуюся в обращении обыкновенную акцию компании. Дивиденды выплачиваются 16 июня 2022 года акционерам record на момент закрытия бизнеса 16 мая 2022 года.
По состоянию на 31 марта 2022 года денежные средства и их эквиваленты составляли 694 миллиона долларов, а долг - 9 094 миллиона долларов, в результате чего чистый долг составил 8 400 миллионов долларов.
Руководство на весь год
Organon не предоставляет прогнозные финансовые показатели по GAAP, поскольку компания не может с достаточной уверенностью и без необоснованных усилий предсказать конечный результат судебного разбирательства, необычные прибыли и убытки, возникновение вопросов, создающих налоговые последствия по GAAP, и расходы, связанные с приобретением. Эти статьи являются неопределенными, зависят от различных факторов и могут иметь существенное значение для результатов Organon, рассчитанных в соответствии с GAAP.
Начиная с 2022 года Organon больше не будет исключать из своих результатов, не относящихся к GAAP, расходы на авансовые и поэтапные платежи, связанные с сотрудничеством и лицензионными соглашениями, или расходы, связанные с предварительно одобренными активами, полученными в результате операций, учитываемых как приобретение активов. Эти изменения вносятся в соответствии с мнениями, выраженными Комиссией по ценным бумагам и биржам США. За периоды, закончившиеся 31 марта 2022 года или 31 марта 2021 года, такие расходы или сборы на исследования и разработки в процессе производства отсутствуют. Соответствующие предыдущие периоды были изменены, чтобы отразить эти изменения, и их можно найти в таблицах 7 и 8 настоящего пресс-релиза.
Финансовое руководство Organon не предполагает оценки будущих текущих исследований и разработок для еще не выполненных операций по развитию бизнеса.
Компания подтвердила финансовые рекомендации на весь 2022 год, ранее представленные 17 февраля 2022 года, которые представлены на основе, отличной от GAAP.
|
|
Previous guidance |
|
Current guidance |
Revenue |
|
$6.1B - $6.4B |
|
Unchanged |
Adjusted gross margin |
|
Mid 60% |
|
Unchanged |
SG&A as % of revenue |
|
Mid 20% |
|
Unchanged |
R&D as % of revenue |
|
Mid to upper single digit |
|
Unchanged |
Adjusted EBITDA margin |
|
34%-36% |
|
Unchanged |
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 |
Информация о веб-трансляции
Сегодня в 8:30 утра по восточному времени Organon проведет телефонную конференцию, на которой обсудит финансовые результаты за первый квартал 2022 года. Чтобы прослушать мероприятие и просмотреть слайды презентации через веб-трансляцию, зарегистрируйтесь на веб-сайте Organon по связям с инвесторами по адресу https://www.organon.com/investor-relations /. Повтор веб-трансляции будет доступен примерно через два часа после завершения прямого эфира на веб-сайте компании. Институциональные инвесторы и аналитики, заинтересованные в участии в конкурсе, должны зарегистрироваться заранее, используя идентификатор конференции # 6895016 и перейдя по этой ссылке: http://www.directeventreg.com/registration/event/6895016 . После регистрации участники получат электронное письмо с подтверждением, содержащее подробную информацию о том, как присоединиться к конференц-звонку, включая информацию о наборе номера, уникальный код доступа и идентификатор владельца регистрации. Предварительная регистрация позволит участникам обойти оператора и подключиться непосредственно к вызову.
Organon - глобальная медицинская компания, созданная путем выделения из Merck & Co., Inc., Рауэй, Нью-Джерси, США (NYSE: MRK), чтобы сосредоточиться на улучшении здоровья женщин на протяжении всей их жизни. Organon располагает портфелем из более чем 60 лекарственных средств и продуктов в различных терапевтических областях. Возглавляемая портфелем продуктов women's health в сочетании с расширяющимся бизнесом биоаналогов и стабильной франшизой известных лекарств, продукция Organon обеспечивает значительные денежные потоки, которые поддержат инвестиции в инновации и будущие возможности роста в области женского здоровья. Кроме того, Organon ищет возможности для сотрудничества с инноваторами в области биофармацевтики, стремящимися коммерциализировать свои продукты, используя свои масштабы и присутствие на быстрорастущих международных рынках.
Organon имеет глобальное присутствие со значительным масштабом и географическим охватом, коммерческими возможностями мирового класса и примерно 9300 сотрудниками со штаб-квартирой, расположенной в Джерси-Сити, штат Нью-Джерси.
Для получения дополнительной информации посетите http://www.organon.com и свяжитесь с нами через LinkedIn и Instagram.
Финансовые показатели, не относящиеся к ОПБУ
Настоящий пресс-релиз содержит “финансовые показатели, не относящиеся к GAAP”, которые представляют собой финансовые показатели, которые либо исключают, либо включают суммы, которые не исключаются или не включаются в наиболее непосредственно сопоставимые показатели, рассчитанные и представленные в соответствии с общепринятыми принципами бухгалтерского учета США (“GAAP”).). В частности, компания использует финансовые показатели, не относящиеся к GAAP, Скорректированную EBITDA, Скорректированную Чистую прибыль и Скорректированную разводненную прибыль на акцию, которые не признаются в соответствии с GAAP и представлены только в качестве дополнения к финансовой отчетности компании по GAAP. Компания считает, что эти финансовые показатели, не относящиеся к GAAP, помогают лучше понять финансовые показатели компании. Однако представление этих показателей в качестве аналитического инструмента имеет ограничения и не должно рассматриваться изолированно или в качестве замены результатов компании, представленных в соответствии с GAAP. Поскольку не все компании используют идентичные расчеты, представления этих показателей, не относящихся к GAAP, могут быть несопоставимы с другими аналогичными показателями других компаний. Вам следует обратиться к приложению к настоящему пресс-релизу для получения соответствующих определений и сверки финансовых показателей, не относящихся к GAAP, содержащихся здесь, с наиболее непосредственно сопоставимыми показателями GAAP.
Кроме того, ориентировочные показатели компании на весь 2022 год (кроме выручки) предоставляются на основе, отличной от GAAP, поскольку компания не может разумно прогнозировать определенные статьи, содержащиеся в показателях GAAP. Такие статьи включают, но не ограничиваются ими, расходы, связанные с приобретением, реструктуризацией и сопутствующими расходами, компенсацией на основе акций и другими статьями, не отражающими текущую деятельность компании.
Компания использует финансовые показатели, не относящиеся к GAAP, при принятии своих операционных и финансовых решений и считает, что полезно исключить определенные статьи, чтобы сосредоточиться на том, что, по ее мнению, является более значимым представлением основных операционных показателей бизнеса.
Прогнозное заявление
За исключением приведенной здесь исторической информации, этот пресс-релиз включает “заявления прогнозного характера” по смыслу положений Закона о реформе судебных разбирательств по частным ценным бумагам США 1995 года о безопасной гавани, включая, но не ограничиваясь, заявлениями об ожиданиях руководства относительно будущих финансовых показателей и перспектив Organon. Заявления прогнозного характера могут быть идентифицированы такими словами, как “ожидает”, “намеревается”, “ожидает”, “планирует”, “полагает”, “стремится”, “оценивает”, “будет” или словами аналогичного значения. Эти заявления основаны на текущих убеждениях и ожиданиях руководства компании и подвержены значительным рискам и неопределенностям. Если лежащие в основе допущения окажутся неточными или возникнут риски или неопределенности, фактические результаты могут существенно отличаться от тех, которые изложены в прогнозных заявлениях.
Риски и неопределенности включают, но не ограничиваются ими, неспособность реализовать нашу стратегию развития бизнеса или реализовать преимущества наших запланированных приобретений; общие условия в отрасли и конкуренция; общие экономические факторы, включая колебания процентных ставок и валютных курсов; влияние продолжающейся пандемии COVID-19 и появление различные штаммы; влияние регулирования фармацевтической промышленности и законодательства в области здравоохранения в Соединенных Штатах и на международном уровне; глобальные тенденции к сдерживанию расходов на здравоохранение; технологические достижения; новые продукты и патенты, полученные конкурентами; проблемы, связанные с разработкой новых продуктов, включая получение одобрения регулирующих органов; способность компании точно прогнозировать свое будущее финансовые результаты и производительность; производственные трудности или задержки; финансовая нестабильность международной экономики и суверенный риск; трудности в развитии и поддержании отношений с коммерческими контрагентами; зависимость от эффективности патентов компании и других средств защиты инновационных продуктов; и подверженность судебным разбирательствам, включая патентные споры, и/или действия регулирующих органов.
Компания не берет на себя никаких обязательств по публичному обновлению каких-либо прогнозных заявлений, будь то в результате новой информации, будущих событий или иным образом. Дополнительные факторы, которые могут привести к существенному отличию результатов от тех, которые описаны в прогнозных заявлениях, можно найти в заявках компании в Комиссию по ценным бумагам и биржам ("SEC"), включая Годовой отчет компании по форме 10-K за год, закончившийся 31 декабря 2021 года, и последующие SEC заявки, доступные на интернет-сайте SEC (www.sec.gov ).
TABLE 1 |
|||||||
Organon & Co. Condensed Consolidated Statement of Income (Unaudited, $ in millions except share and per share amounts) |
|||||||
|
Three Months Ended March 31, |
||||||
|
2022 |
|
|
2021 |
|
||
Revenues |
$ |
1,567 |
|
$ |
1,506 |
|
|
Costs, Expenses and Other |
|
|
|
||||
Cost of sales |
|
561 |
|
|
591 |
|
|
Selling, general and administrative |
|
371 |
|
|
382 |
|
|
Research and development |
|
96 |
|
|
67 |
|
|
Restructuring costs |
|
— |
|
|
1 |
|
|
Other (income) expense, net |
|
97 |
|
|
(2 |
) |
|
|
|
1,125 |
|
|
1,039 |
|
|
Income From Continuing Operations Before Income Taxes |
|
442 |
|
|
467 |
|
|
Taxes on Income |
|
94 |
|
|
72 |
|
|
Net Income From Continuing Operations |
|
348 |
|
|
395 |
|
|
Income From Discontinued Operations - Net of Tax |
|
— |
|
|
4 |
|
|
Net Income |
|
348 |
|
|
399 |
|
|
Earnings per Share Attributable to Organon & Co. Stockholders - Basic: |
|
|
|
||||
Continuing operations |
$ |
1.37 |
|
$ |
1.56 |
|
|
Discontinued operations |
|
— |
|
|
0.02 |
|
|
Net Earnings per Share Attributable to Organon & Co. Stockholders |
$ |
1.37 |
|
$ |
1.58 |
|
|
Earnings per Share Attributable to Organon & Co. Stockholders - Diluted: |
|
|
|
||||
Continuing operations |
$ |
1.36 |
|
$ |
1.56 |
|
|
Discontinued operations |
|
— |
|
|
0.02 |
|
|
Net Earnings per Share Attributable to Organon & Co. Stockholders |
$ |
1.36 |
|
$ |
1.58 |
|
|
Weighted Average Shares Outstanding: |
|
|
|
||||
Basic |
|
253,583,000 |
|
|
253,516,000 |
|
|
Diluted |
|
255,052,000 |
|
|
253,516,000 |
|
TABLE 2 |
|||||||||||||||||||||||
Organon & Co. Sales by top products |
|||||||||||||||||||||||
|
Three Months Ended March 31, |
||||||||||||||||||||||
|
2022 |
|
2021 |
||||||||||||||||||||
($ in millions) |
U.S. |
|
Int’l |
|
Total |
|
U.S. |
|
Int’l |
|
Total |
||||||||||||
Women’s Health |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Nexplanon/Implanon NXT |
$ |
116 |
|
$ |
55 |
|
$ |
171 |
|
$ |
141 |
|
|
$ |
42 |
|
$ |
183 |
|||||
Follistim AQ |
|
30 |
|
|
31 |
|
|
61 |
|
|
25 |
|
|
|
27 |
|
|
52 |
|||||
NuvaRing |
|
16 |
|
|
24 |
|
|
41 |
|
|
21 |
|
|
|
24 |
|
|
45 |
|||||
Ganirelix Acetate Injection |
|
8 |
|
|
22 |
|
|
30 |
|
|
8 |
|
|
|
21 |
|
|
29 |
|||||
Cerazette |
|
— |
|
|
18 |
|
|
18 |
|
|
— |
|
|
|
17 |
|
|
17 |
|||||
Other Women's Health (1) |
|
27 |
|
|
31 |
|
|
57 |
|
|
40 |
|
|
|
33 |
|
|
73 |
|||||
Biosimilars |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Renflexis |
|
42 |
|
|
4 |
|
|
46 |
|
|
35 |
|
|
|
4 |
|
|
38 |
|||||
Ontruzant |
|
7 |
|
|
15 |
|
|
22 |
|
|
4 |
|
|
|
19 |
|
|
22 |
|||||
Brenzys |
|
— |
|
|
14 |
|
|
14 |
|
|
— |
|
|
|
10 |
|
|
10 |
|||||
Aybintio |
|
— |
|
|
10 |
|
|
10 |
|
|
— |
|
|
|
8 |
|
|
8 |
|||||
Hadlima |
|
— |
|
|
6 |
|
|
6 |
|
|
— |
|
|
|
2 |
|
|
2 |
|||||
Established Brands |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cardiovascular |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Zetia |
|
3 |
|
|
96 |
|
|
99 |
|
|
2 |
|
|
|
89 |
|
|
92 |
|||||
Vytorin |
|
2 |
|
|
36 |
|
|
38 |
|
|
3 |
|
|
|
38 |
|
|
41 |
|||||
Atozet |
|
— |
|
|
119 |
|
|
119 |
|
|
— |
|
|
|
112 |
|
|
112 |
|||||
Rosuzet |
|
— |
|
|
22 |
|
|
22 |
|
|
— |
|
|
|
15 |
|
|
15 |
|||||
Cozaar/Hyzaar |
|
8 |
|
|
86 |
|
|
93 |
|
|
3 |
|
|
|
87 |
|
|
90 |
|||||
Other Cardiovascular (1) |
|
1 |
|
|
38 |
|
|
39 |
|
|
1 |
|
|
|
38 |
|
|
39 |
|||||
Respiratory |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Singulair |
|
3 |
|
|
127 |
|
|
130 |
|
|
5 |
|
|
|
102 |
|
|
107 |
|||||
Nasonex |
|
9 |
|
|
65 |
|
|
75 |
|
|
2 |
|
|
|
41 |
|
|
43 |
|||||
Dulera |
|
31 |
|
|
9 |
|
|
40 |
|
|
31 |
|
|
|
8 |
|
|
38 |
|||||
Clarinex |
|
1 |
|
|
37 |
|
|
38 |
|
|
1 |
|
|
|
23 |
|
|
25 |
|||||
Other Respiratory (1) |
|
12 |
|
|
11 |
|
|
22 |
|
|
16 |
|
|
|
6 |
|
|
23 |
|||||
Non-Opioid Pain, Bone and Dermatology |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Arcoxia |
|
— |
|
|
60 |
|
|
60 |
|
|
— |
|
|
|
56 |
|
|
56 |
|||||
Fosamax |
|
1 |
|
|
40 |
|
|
41 |
|
|
1 |
|
|
|
37 |
|
|
38 |
|||||
Diprospan |
|
— |
|
|
31 |
|
|
31 |
|
|
— |
|
|
|
26 |
|
|
26 |
|||||
Other Non-Opioid Pain, Bone and Dermatology (1) |
|
3 |
|
|
66 |
|
|
69 |
|
|
(1 |
) |
|
|
62 |
|
|
61 |
|||||
Other |
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Proscar |
|
— |
|
|
24 |
|
|
24 |
|
|
— |
|
|
|
32 |
|
|
32 |
|||||
Propecia |
|
1 |
|
|
29 |
|
|
30 |
|
|
2 |
|
|
|
29 |
|
|
31 |
|||||
Other (1) |
|
8 |
|
|
74 |
|
|
83 |
|
|
11 |
|
|
|
78 |
|
|
89 |
|||||
Other (2) |
|
— |
|
|
37 |
|
|
37 |
|
|
— |
|
|
|
69 |
|
|
69 |
|||||
Total Revenue |
$ |
329 |
|
$ |
1,238 |
|
$ |
1,567 |
|
$ |
351 |
|
|
$ |
1,155 |
$ |
1,506 |
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) |
Includes sales of products not listed separately. Revenue from an arrangement for the sale of generic etonogestrel/ethinyl estradiol vaginal ring is included in Other Women's Health. | |
(2) |
Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities. |
TABLE 3 |
|||||||
Organon & Co. Sales by geographic area (Unaudited, $ in millions) |
|||||||
|
Three Months Ended March 31, |
||||||
($ in millions) |
2022 |
|
2021 |
||||
Europe and Canada |
$ |
436 |
|
$ |
434 |
||
United States |
|
329 |
|
|
351 |
||
Asia Pacific and Japan |
|
314 |
|
|
278 |
||
China |
|
236 |
|
|
206 |
||
Latin America, Middle East, Russia and Africa |
|
209 |
|
|
167 |
||
Other (1) |
|
43 |
|
|
70 |
||
Revenue |
$ |
1,567 |
|
$ |
1,506 |
(1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ, USA and other third parties, and allocated amounts from pre-spin revenue hedging activities. |
TABLE 4 |
|||||||
Reconciliation of GAAP Gross Margin to Non-GAAP Adjusted Gross Profit and Adjusted Gross Margin ($ in millions) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2022 |
|
|
|
2021 |
|
Revenue |
$ |
1,567 |
|
|
$ |
1,506 |
|
Cost of sales |
|
561 |
|
|
|
591 |
|
Gross Profit |
|
1,006 |
|
|
|
915 |
|
Gross Margin |
|
64.2 |
% |
|
|
60.8 |
% |
Amortization |
|
28 |
|
|
|
20 |
|
One-time costs (1) |
|
5 |
|
|
|
— |
|
Stock-based compensation |
|
3 |
|
|
|
2 |
|
Non-GAAP Adjusted Gross Profit (2) |
$ |
1,042 |
|
|
$ |
937 |
|
Non-GAAP Adjusted Gross Margin |
|
66.5 |
% |
|
|
62.2 |
% |
(1) One-time costs for the three months ended March 31, 2022 primarily include costs to stand up the Company. |
(2) Non-GAAP Adjusted Gross Profit is calculated by excluding amortization, one-time costs, and the portion of stock-based compensation expense allocated to Cost of sales. |
TABLE 5 |
|||||||
Organon & Co. Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Adjusted EBITDA ($ in millions) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2022 |
|
|
|
2021 |
|
Income from continuing operations before income taxes |
$ |
442 |
|
|
$ |
467 |
|
Depreciation |
|
25 |
|
|
|
18 |
|
Amortization (1) |
|
28 |
|
|
|
20 |
|
Interest expense |
|
97 |
|
|
|
— |
|
EBITDA |
|
592 |
|
|
|
505 |
|
Restructuring costs |
|
— |
|
|
|
1 |
|
One-time costs (2) |
|
40 |
|
|
|
49 |
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
Stock-based compensation |
|
15 |
|
|
|
11 |
|
Adjusted EBITDA |
$ |
647 |
|
|
$ |
566 |
|
Adjusted EBITDA margin |
|
41.3 |
% |
|
|
37.6 |
% |
(1) Amortization in all periods is included in Cost of sales. |
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon. For the three months ended March 31, 2022, approximately $25 million of the one-time costs are recorded in Selling, general and administrative expenses, $6 million are recorded in Other (income) expense, $5 million are recorded in Cost of sales, and $4 million are recorded in Research and development. For the three months ended March 31, 2021, $49 million of the one-time costs are classified in Selling, general and administrative expenses. |
TABLE 6 |
|||||||
Organon & Co. Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Non-GAAP Adjusted Net Income ($ in millions, except per share amounts) |
|||||||
|
Three Months Ended March 31, |
||||||
|
|
2022 |
|
|
|
2021 |
|
Income from continuing operations before income taxes |
$ |
442 |
|
|
$ |
467 |
|
Adjustments: |
|
|
|
||||
Amortization (1) |
|
28 |
|
|
|
20 |
|
Restructuring costs |
|
— |
|
|
|
1 |
|
One-time costs (2) |
|
40 |
|
|
|
49 |
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
Stock-based compensation |
|
15 |
|
|
|
11 |
|
Total Adjustments |
|
83 |
|
|
|
81 |
|
Non-GAAP pre-tax income from continuing operations |
|
525 |
|
|
|
548 |
|
Taxes on income as reported in accordance with GAAP |
|
94 |
|
|
|
72 |
|
Tax benefit on adjustments |
|
14 |
|
|
|
15 |
|
Tax (deduction)/benefit on GAAP-only discrete items |
|
(3 |
) |
|
|
10 |
|
Non-GAAP adjusted taxes on income |
|
105 |
|
|
|
97 |
|
Non-GAAP adjusted net income, continuing operations |
|
420 |
|
|
|
451 |
|
Non-GAAP adjusted net income, continuing operations per diluted share |
$ |
1.65 |
|
|
$ |
1.78 |
(1) Amortization in all periods is included in Cost of sales. |
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon. For the three months ended March 31, 2022, approximately $25 million of the one-time costs are recorded in Selling, general and administrative expenses, $6 million are recorded in Other (income) expense, $5 million are recorded in Cost of sales, and $4 million are recorded in Research and development. For the three months ended March 31, 2021, $49 million of the one-time costs are classified in Selling, general and administrative expenses. |
TABLE 7 |
|||||||||||||||||||||||||||||||||||
Organon & Co. |
|||||||||||||||||||||||||||||||||||
Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Adjusted EBITDA |
|||||||||||||||||||||||||||||||||||
($ in millions) |
|||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
Q1 2021 |
|
Q2 2021 |
|
Q3 2021 |
|
Q4 2021 |
|
FY 2021 |
||||||||||||||||||||||||||
|
As
|
|
As
|
|
As
|
|
Impact of
|
|
Recast |
|
As
|
|
Impact of
|
|
Recast |
|
As
|
|
Impact of
|
|
Recast |
||||||||||||||
Income from continuing operations before income taxes |
$ |
467 |
|
$ |
437 |
|
$ |
389 |
|
$ |
— |
|
|
$ |
389 |
|
$ |
236 |
|
$ |
— |
|
|
$ |
236 |
|
$ |
1,529 |
|
$ |
— |
|
|
$ |
1,529 |
Depreciation |
|
18 |
|
|
21 |
|
|
25 |
|
|
— |
|
|
|
25 |
|
|
28 |
|
|
— |
|
|
|
28 |
|
|
92 |
|
|
— |
|
|
|
92 |
Amortization (1) |
|
20 |
|
|
22 |
|
|
27 |
|
|
— |
|
|
|
27 |
|
|
34 |
|
|
— |
|
|
|
34 |
|
|
103 |
|
|
— |
|
|
|
103 |
Interest expense |
|
— |
|
|
62 |
|
|
98 |
|
|
— |
|
|
|
98 |
|
|
98 |
|
|
— |
|
|
|
98 |
|
|
258 |
|
|
— |
|
|
|
258 |
EBITDA |
$ |
505 |
|
$ |
542 |
|
$ |
539 |
|
$ |
— |
|
|
$ |
539 |
|
$ |
396 |
|
$ |
— |
|
|
$ |
396 |
|
$ |
1,982 |
|
$ |
— |
|
|
$ |
1,982 |
Restructuring costs |
|
1 |
|
|
1 |
|
|
1 |
|
|
— |
|
|
|
1 |
|
|
— |
|
|
— |
|
|
|
— |
|
|
3 |
|
|
— |
|
|
|
3 |
One-time costs (2) |
|
49 |
|
|
66 |
|
|
56 |
|
|
— |
|
|
|
56 |
|
|
59 |
|
|
— |
|
|
|
59 |
|
|
231 |
|
|
— |
|
|
|
231 |
Acquired in-process research and development (3) |
|
— |
|
|
— |
|
|
25 |
|
|
(25 |
) |
|
|
— |
|
|
79 |
|
|
(79 |
) |
|
|
— |
|
|
104 |
|
|
(104 |
) |
|
|
— |
Stock-based compensation |
|
11 |
|
|
18 |
|
|
15 |
|
|
— |
|
|
|
15 |
|
|
15 |
|
|
— |
|
|
|
15 |
|
|
59 |
|
|
— |
|
|
|
59 |
Adjusted EBITDA |
$ |
566 |
|
$ |
627 |
|
$ |
636 |
|
$ |
(25 |
) |
|
$ |
611 |
|
$ |
549 |
|
$ |
(79 |
) |
|
$ |
470 |
|
$ |
2,379 |
|
$ |
(104 |
) |
|
$ |
2,275 |
(1) Amortization in all periods is included in Cost of sales. |
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon as well as acquisition related costs. Refer to the Company's previously filed Current Reports on Form 8-K for a further description of these costs for each reported period. |
(3) Costs represent upfront licensing payment associated with ObsEva of $25 million during the third quarter of 2021 and Forendo of $79 million in the fourth quarter of 2021, which were recorded in Research and development expense. |
(4) The change does not affect the previously reported Adjusted EBITDA results for the first and second quarter of 2021 as there were no adjustments which affected either of the periods. |
TABLE 8 |
|||||||||||||||||||||||||||||||||||
Organon & Co. |
|||||||||||||||||||||||||||||||||||
Reconciliation of GAAP Income from Continuing Operations Before Income Taxes to Non-GAAP Adjusted Net Income |
|||||||||||||||||||||||||||||||||||
($ in millions, except per share amounts) |
|||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
Q1 2021 |
|
Q2 2021 |
|
Q3 2021 |
|
Q4 2021 |
|
FY 2021 |
||||||||||||||||||||||||||
|
As
|
|
As
|
|
As
|
|
Impact of
|
|
Recast |
|
As
|
|
Impact of
|
|
Recast |
|
As
|
|
Impact of
|
|
Recast |
||||||||||||||
Income from continuing operations before income taxes |
$ |
467 |
|
$ |
437 |
|
$ |
389 |
|
$ |
— |
|
|
$ |
389 |
|
$ |
236 |
|
$ |
— |
|
|
$ |
236 |
|
$ |
1,529 |
|
$ |
— |
|
|
$ |
1,529 |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Amortization (1) |
|
20 |
|
|
22 |
|
|
27 |
|
|
— |
|
|
|
27 |
|
|
34 |
|
|
— |
|
|
|
34 |
|
|
103 |
|
|
— |
|
|
|
103 |
Restructuring costs |
|
1 |
|
|
1 |
|
|
1 |
|
|
— |
|
|
|
1 |
|
|
— |
|
|
— |
|
|
|
— |
|
|
3 |
|
|
— |
|
|
|
3 |
One-time costs (2) |
|
49 |
|
|
66 |
|
|
56 |
|
|
— |
|
|
|
56 |
|
|
59 |
|
|
— |
|
|
|
59 |
|
|
231 |
|
|
— |
|
|
|
231 |
Acquired in-process research and development (3) |
|
— |
|
|
— |
|
|
25 |
|
|
(25 |
) |
|
|
— |
|
|
79 |
|
|
(79 |
) |
|
|
— |
|
|
104 |
|
|
(104 |
) |
|
|
— |
Stock-based compensation |
|
11 |
|
|
18 |
|
|
15 |
|
|
— |
|
|
|
15 |
|
|
15 |
|
|
— |
|
|
|
15 |
|
|
59 |
|
|
— |
|
|
|
59 |
Total Adjustments |
|
81 |
|
|
107 |
|
|
124 |
|
|
(25 |
) |
|
|
99 |
|
|
187 |
|
|
(79 |
) |
|
|
108 |
|
|
500 |
|
|
(104 |
) |
|
|
396 |
Non-GAAP pre-tax income from continuing operations |
$ |
548 |
|
$ |
544 |
|
$ |
513 |
|
$ |
(25 |
) |
|
$ |
488 |
|
$ |
423 |
|
$ |
(79 |
) |
|
$ |
344 |
|
$ |
2,029 |
|
$ |
(104 |
) |
|
$ |
1,925 |
Taxes on income as reported in accordance with GAAP |
|
72 |
|
|
6 |
|
|
66 |
|
|
— |
|
|
|
66 |
|
|
34 |
|
|
— |
|
|
|
34 |
|
|
178 |
|
|
— |
|
|
|
178 |
Tax benefit on adjustments |
|
15 |
|
|
20 |
|
|
23 |
|
|
(2 |
) |
|
|
21 |
|
|
35 |
|
|
(17 |
) |
|
|
18 |
|
|
93 |
|
|
(19 |
) |
|
|
74 |
Tax benefit on GAAP-only discrete items (4) |
|
10 |
|
|
81 |
|
|
— |
|
|
— |
|
|
|
— |
|
|
5 |
|
|
— |
|
|
|
5 |
|
|
96 |
|
|
— |
|
|
|
96 |
Non-GAAP adjusted taxes on income |
$ |
97 |
|
$ |
107 |
|
$ |
89 |
|
$ |
(2 |
) |
|
$ |
87 |
|
$ |
74 |
|
$ |
(17 |
) |
|
$ |
57 |
|
$ |
367 |
|
$ |
(19 |
) |
|
$ |
348 |
Non-GAAP adjusted net income, continuing operations |
$ |
451 |
|
$ |
437 |
|
$ |
424 |
|
$ |
(23 |
) |
|
$ |
401 |
|
$ |
349 |
|
$ |
(62 |
) |
|
$ |
287 |
|
$ |
1,662 |
|
$ |
(85 |
) |
|
$ |
1,577 |
Non-GAAP adjusted net income from continuing operations per diluted share |
$ |
1.78 |
|
$ |
1.72 |
|
$ |
1.67 |
|
$ |
(0.09 |
) |
|
$ |
1.58 |
|
$ |
1.37 |
|
$ |
(0.24 |
) |
|
$ |
1.13 |
|
$ |
6.54 |
|
$ |
(0.33 |
) |
|
$ |
6.20 |
(1) Amortization in all periods is included in Cost of sales. |
(2) One-time costs primarily include costs incurred in connection with the spin-off of Organon as well as acquisition related costs. Refer to the Company's previously filed Form 8-Ks for a further description of these costs for each reported period. |
(3) Costs represent upfront licensing payment associated with ObsEva of $25 million during the third quarter of 2021 and Forendo of $79 million in the fourth quarter of 2021, which were recorded in Research and development expense. |
(4) Amounts include a tax benefit of approximately $70 million recorded in the second quarter of 2021 and a tax benefit of $5 million recorded in the fourth quarter of 2021 related to a portion of non-US step up in tax basis as a result of its separation from Merck & Co., Inc., Rahway, NJ, USA. |
(5) The change does not affect the previously reported Non-GAAP results for the first and second quarter of 2021 as there were no adjustments which affected either of the periods. |