EX-99.1 2 tm2131080d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

 

 

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 third quarter ended September 30, 2021

 

Third quarter 2021 revenue of $1,600 million

Net income from continuing operations of $323 million, or $1.27 per diluted share; Adjusted net income from continuing operations of $424 million, or $1.67 per diluted share

Adjusted EBITDA of $636 million

Board of Directors declares quarterly dividend of $0.28 per share

Financial guidance affirmed; ranges for revenue and Adjusted EBITDA margin, narrowed

Executing on business development; announces acquisition of Forendo Pharma

 

Jersey City, N.J., November 11, 2021 – Organon (NYSE: OGN) (the “company”), today announced its results for the third quarter and year to date ended September 30, 2021.

 

Organon also announced that its 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 16, 2021 to stockholders of record at the close of business on November 22, 2021.

 

"Just months after becoming a standalone company, we are delivering on what we set out to do. Our year to date results are very much in line with expectations, and with good visibility into the remainder of the year, we are affirming our financial guidance," said Kevin Ali, Organon's CEO. "Importantly, we have also been disciplined in actioning business development opportunities that have been in the works well prior to spin. Including today's announcement regarding the proposed acquisition of Forendo Pharma, we have executed three transactions in the last six months, demonstrating our commitment to advance innovation in large, underserved markets, which women’s health has lacked for decades."

 

Third quarter 2021 revenue

 

in $ millions  Q3 2021   Q3 2020   VPY   VPY ex-FX 
Women’s Health   381    424    (10)%   (11)%
Biosimilars   140    99    41%   39%
Established Brands   1,027    1,088    (6)%   (8)%
Other(1)   52    2    NM    NM 
Revenue   1,600    1,613    (1)%   (3)%

 

(1) Other represents manufacturing sales to the company’s former parent company and other third parties and pre-spin allocated revenue hedge activities

 

 

 

Total net revenue was $1,600 million for the third quarter of 2021, a decrease of 1% as-reported and 3% excluding the impacts of foreign currency (ex-FX), compared with the third quarter of 2020.

 

Women’s Health declined 10% as-reported and 11% ex-FX in the third quarter 2021 compared with the third quarter of 2020, driven primarily by a 17% ex-FX decline in NUVARING® (etonogestrel/ethinyl estradiol vaginal ring) which continues to be impacted by generic competition, and also NEXPLANON® (etonogestrel implant), which declined 8% ex-FX in the third quarter 2021. In September 2020, there was short-lived resurgence in patient well visits that positively impacted third quarter 2020 NEXPLANON sales, which is a physician-administered product. Throughout the current year, well visits in the US continue to be suppressed by the COVID-19 pandemic, hampering NEXPLANON sales. The decline in the company's contraception portfolio was partially offset by the fertility franchise, led by FOLLISTIM®, AQ Cartridge (follitropin beta injection) which grew 18% ex-FX, and was positively impacted by a combination of COVID-19 recovery and increased demand.

 

Biosimilars revenue grew 41% as-reported and 39% ex-FX in the third quarter 2021 compared with third quarter 2020, driven by continued demand growth in the US for RENFLEXIS® (infliximab-abda), since its launch in 2017 as well as growth in Canada. The biosimilars portfolio also benefited from the continued uptake of ONTRUZANT® (trastuzumab-dttb) in the US since the July 2020 launch in the US, as well as strong performance in Brazil, partially offset by a decrease in the EU reflecting increasing competitive pressures and tenders lost.

 

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. Revenue for Established Brands was down 6% as-reported and down 8% ex-FX in the third quarter of 2021. Excluding the impact of loss of exclusivity (LOE), Established Brands revenue was down 4% ex-FX. During the quarter, retail expansion in China grew 20% and partially offset impacts from decreases in the hospital channel due to Volume Based Procurement (VBP). The portfolio impacts from LOE as well as VBP were partially offset by a 3% ex-FX increase in respiratory medicines. SINGULAIR® (montelukast) was up 20% ex-FX due to higher volume and recovery from the COVID-19 pandemic in China, despite its exposure to VBP, and NASONEX® (mometasone) was up 13% ex-FX due to higher demand in China and favorable performance in Russia, partially offset by generic competition in Japan.

 

 

 

Third quarter 2021 profitability

 

in $ millions, except per share amounts  Q3 2021   Q3 2020   VPY 
Revenue  $1,600   $1,613    (1)%
Cost of goods sold   609    535    14%
Gross profit   991    1,078    (8)%
Gross margin   61.9%   66.8%     
Non-GAAP Adjusted gross profit(1)   1,038    1,106    (6)%
Non-GAAP Adjusted gross margin   64.9%   68.6%     
Adjusted EBITDA, continuing operations(1,2)   636    751    (15)%
Adjusted EBITDA margin, continuing operations   39.8%   46.6%     
Net Income, continuing operations(2)   323    560    (42)%
Non-GAAP Adjusted net income, continuing operations(1,2)   424    604    (30)%
Diluted Earnings per Share, continuing operations(2)   1.27    2.21    (43)%
Non-GAAP Adjusted Diluted Earnings per Share, continuing operations(1,2)   1.67    2.38    (30)%

 

(1) See Tables 4,5 and 6 for reconciliations of GAAP to non-GAAP measures

 

(2) Discontinued operations includes Merck Retained Products

 

Gross margin was 61.9% as-reported and 64.9% on an adjusted basis in the third quarter of 2021 compared with 66.8% as-reported and 68.6% on an adjusted basis in the third quarter of 2020. The year-over-year decrease reflects costs of standing up Organon as an independent company, including certain costs related to manufacturing agreements between the company and its former parent company, which have lower gross margin percentages compared to third party product sales and purchases. Those manufacturing agreements had an approximate 180 basis point negative impact to gross margins.

 

Adjusted EBITDA margin was 39.8% in the third quarter of 2021 compared with 46.6% in the third quarter of 2020, which reflects costs incurred to establish Organon as a stand alone entity.

 

Net income from continuing operations for the third quarter of 2021 was $323 million, or $1.27 per diluted share, compared with $560 million, or $2.21 per diluted share, in the third quarter of 2020. Non-GAAP Adjusted net income from continuing operations was $424 million, or $1.67 per diluted share, compared with $604 million, or $2.38 per diluted share, in 2020.

 

 

 

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 16, 2021 to stockholders of record at the close of business on November 22, 2021.

 

As of September 30, 2021, cash and cash equivalents were $1,008 million, and debt was $9,298 million, resulting in net debt of $8,290 million.

 

Full year guidance – all guidance provided on a Non-GAAP basis

 

Organon does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty and without unreasonable effort, the ultimate outcome of legal proceedings, unusual gains and losses, 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 affirmed all financial guidance, and narrowed the ranges for revenue and Adjusted EBITDA margin. The financial guidance is presented on a non-GAAP basis and is proforma as if Organon was a standalone company for the entire year.

 

Guidance on proforma non-GAAP basis  Previous guidance  Current guidance
Revenue  $6.1B - $6.4B  $6.2B - 6.3B
Gross margin(*)  Low to mid-60% range  Unchanged
SG&A as % of sales(*)  Mid 20% range  Unchanged
R&D as % of sales(*)  Mid single-digit  Unchanged
Adjusted EBITDA margin  36%-38%  36.5%-37.5%
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  ~254 million  Unchanged

 

(*) Guidance provided in connection with the spin-off and unlikely to be a recurring component of the company’s annual guidance

 

 

 

Webcast Information

 

Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its third quarter 2021 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 by clicking on this link: http://www.directeventreg.com/registration/event/2594964. 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 a global healthcare company formed in June 2021 through a spin-off from Merck (NYSE: MRK) known as MSD outside of the United States and Canada, to focus on improving the health of women throughout their lives. "Here for her health", the company has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive 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 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 and world-class commercial capabilities. The company's approximately 9,000 employees conduct business in more than 140 countries and territories. Organon's headquarters are located in Jersey City, New Jersey.

 

Non-GAAP financial measures

 

Non-GAAP results, such as Adjusted EBITDA, Adjusted Net Income, and Adjusted Diluted EPS, are presented only as a supplement to the company’s financial statements based on GAAP. Non-GAAP financial information is provided to enhance understanding of the company’s financial performance, but none of these non-GAAP financial measures are recognized terms under GAAP, and non-GAAP measures should not be considered in isolation from, or as a substitute analysis for, the company’s results of operations as determined in accordance with GAAP. Definitions and reconciliations of non-GAAP

 

 

 

measures to the most directly comparable GAAP measures are provided within the schedules attached to this release. The company uses non-GAAP 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. The company also believes that investors may find non-GAAP financial measures useful for the same reasons, although investors are cautioned that non-GAAP financial measures are not a substitute for GAAP disclosures. The non-GAAP financial measures are not presented in accordance with GAAP. Please refer to the appendix of this press release for reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures. The company’s full-year 2021 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.

 

Forward-Looking Statement of Organon

 

Except for historical information herein, this news 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; the company’s ability to accurately predict future market conditions; 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 its registration statement on Form 10, 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 September 30,   Nine Months Ended September 30, 
   2021   2020   2021   2020 
Sales  $1,600   $1,613   $4,701   $4,919 
Costs, Expenses and Other                    
Cost of sales   609    535    1,783    1,533 
Selling, general and administrative   388    321    1,186    922 
Research and development   111    54    254    150 
Restructuring costs   1    12    3    43 
Other (income) expense, net   102    10    182    44 
    1,211    932    3,408    2,692 
Income From Continuing Operations Before Income Taxes   389    681    1,293    2,227 
Taxes on Income   66    121    144    347 
Net Income From Continuing Operations   323    560    1,149    1,880 
Loss From Discontinued Operations - Net of Tax       (13)       (88)
Net Income  $323   $547   $1,149   $1,792 
                     
Earnings (Loss) per Share Attributable to Organon & Co. Stockholders - Basic:                    
Continuing operations  $1.27   $2.21   $4.53   $7.42 
Discontinued operations       (0.05)       (0.35)
Net Earnings per Share Attributable to Organon & Co. Stockholders  $1.27   $2.16   $4.53   $7.07 
                     
Earnings (Loss) per Share Attributable to Organon & Co. Stockholders - Diluted:                    
Continuing operations  $1.27   $2.21   $4.52   $7.42 
Discontinued operations       (0.05)       (0.35)
Net Earnings per Share Attributable to Organon & Co. Stockholders  $1.27   $2.16   $4.52   $7.07 
                     
Weighted Average Shares Outstanding:                    
Basic   253,534,000    253,516,000    253,530,000    253,516,000 
Diluted   254,172,000    253,516,000    254,011,000    253,516,000 

 

 

 

TABLE 2

 

Organon & Co.

Sales by top products

 

   Three Months Ended September 30,   Nine Months Ended September 30, 
   2021   2020   2021   2020 
($ in millions)  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  $120   $55   $175   $137   $52   $189   $389   $154   $543   $374   $142   $515 
Follistim AQ   29    32    61    20    31    50    81    97    178    60    75    135 
NuvaRing   21    28    49    25    33    58    68    79    147    86    98    184 
Ganirelix Acetate Injection   5    20    25    4    21    25    19    66    85    7    48    55 
Cerazette       18    18        18    18        53    53        51    51 
Other Women's Health (1)   18    35    53    45    39    84    80    111    191    121    103    224 
Biosimilars                                                            
Renflexis   48    6    54    34    4    38    119    17    136    88    8    96 
Ontruzant   9    47    56        37    37    20    81    101    1    77    78 
Brenzys       14    14        23    23        35    35        52    52 
Other Biosimilars (1)       16    16        1    1        34    34        1    1 
Established Brands                                                            
Cardiovascular                                                            
Zetia   1    90    91    (1)   103    103    6    276    282    (4)   389    384 
Vytorin   3    38    41    3    44    47    8    119    127    9    130    139 
Atozet       114    114        111    111        347    347        348    348 
Rosuzet       15    15        32    32        48    48        94    94 
Cozaar/Hyzaar   3    84    87    5    86    91    9    256    265    17    274    291 
Zocor   1    17    18    1    17    18    3    46    49    1    56    57 
Other Cardiovascular (1)       31    31        37    37        99    99        124    124 
Respiratory                                                            
Singulair   2    98    100    4    78    82    10    289    300    14    324    338 
Nasonex       49    48        41    41    3    141    144    9    151    160 
Dulera   48    8    56    51    8    59    121    25    146    155    26    181 
Clarinex   2    27    28    2    23    25    5    78    83    5    104    109 
Asmanex   14    2    15    20    1    21    43    5    48    58    5    64 
Other Respiratory (1)       3    3        11    11        15    16    1    25    26 
Non-Opioid Pain, Bone and Dermatology                                                            
Arcoxia       65    65        68    68        184    184        204    204 
Fosamax   1    45    46    1    45    46    3    130    132    3    137    140 
Diprospan       34    34        33    33        92    92        87    87 
Diprosone       22    22        22    22    1    64    65    1    58    59 
Other Non-Opioid Pain, Bone and Dermatology (1)   9    47    57    3    49    52    11    137    148    5    140    144 
Other                                                            
Proscar       27    27        59    60    1    91    92    1    152    154 
Propecia   1    33    34    2    30    32    5    96    101    7    83    91 
Sinemet       17    17        18    18        54    54    (1)   58    58 
Remeron   1    17    19    1    16    16    3    48    51    2    46    47 
Other (1)   9    49    59    15    48    63    29    128    157    44    135    179 
Other (2)   1    51    52    (1)   3    2    (2)   171    168    4    46    50 
Total sales  $346   $1,254   $1,600   $371   $1,242   $1,613   $1,035   $3,666   $4,701   $1,068   $3,851   $4,919 

 

U.S. plus international may not equal total due to rounding.

 

(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)Includes manufacturing sales to Merck and third parties for current and prior periods and allocated amounts from revenue hedging activities through the date of Separation.

 

 

 

TABLE 3

 

Organon & Co.

Sales by geographic area

(Unaudited, $ in millions)

 

   Three Months Ended September 30,   Nine Months Ended September 30, 
($ in millions)  2021   2020   2021   2020 
Europe and Canada  $410   $426   $1,314   $1,286 
United States   346    371    1,035    1,068 
Asia Pacific and Japan   287    354    874    1,190 
China   252    225    693    655 
Latin America, Middle East, Russia and Africa   238    228    595    649 
Other(1)   67    9    190    71 
Revenue  $1,600   $1,613   $4,701   $4,919 

 

(1)Primarily reflects manufacturing sales to Merck and third parties for current and prior periods and allocated amounts from revenue hedging activities through the date of Separation.

 

TABLE 4

 

Reconciliation of GAAP Gross Margin to Non-GAAP Adjusted Gross Profit and Adjusted Gross Margin

($ in millions)

 

   Three Months Ended September 30,   Nine Months Ended September 30, 
   2021   2020   2021   2020 
Revenue  $1,600   $1,613   $4,701   $4,919 
Cost of Goods Sold   609    535    1,783    1,533 
Gross Profit   991    1,078    2,918    3,386 
Gross Margin   61.9%   66.8%   62.1%   68.8%
Amortization   27    23    69    65 
One-time costs(1)   17        27     
Stock-based compensation   3    5    8    14 
Non-GAAP Adjusted Gross Profit(2)   1,038    1,106    3,022    3,465 
Non-GAAP Adjusted Gross Margin   64.9%   68.6%   64.3%   70.4%

 

(1)One-time costs primarily include inventory discards related to separation re-labeling and other 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 Goods Sold.

 

 

 

TABLE 5

 

Organon & Co.

Reconciliation of GAAP Net Income from Continuing Operations to Adjusted EBITDA

($ in millions)

 

   Three Months Ended September 30,   Nine Months Ended September 30, 
   2021   2020   2021   2020 
Net income from continuing operations before income tax  $389   $681   $1,293   $2,227 
Depreciation   25    17    64    42 
Amortization(1)   27    23    69    65 
Interest expense   98        160     
EBITDA   539    721    1,586    2,334 
Restructuring costs   1    12    3    43 
One-time costs(2)   56    7    171    30 
Acquired in-process research and development(3)   25        25     
Stock-based compensation   15    11    44    32 
Adjusted EBITDA  $636   $751   $1,829   $2,439 
Adjusted EBITDA margin   39.8%   46.6%   38.9%   49.6%

 

(1)Amortization in all periods is included in Cost of goods sold.

 

(2)One-time costs primarily include cost incurred in connection with the spin-off of Organon as well as $23 million of costs incurred in June 2021 pertaining to the Alydia acquisition. For the three months ended September 30, 2021, approximately $35 million of the one-time costs are recorded in Selling, general and administrative expenses, and approximately $17 million are recorded in Cost of goods sold. For the three months ended September 30, 2020, $7 million of the one-time costs are classified in Selling, general and administrative expenses. For the nine months ended September 30, 2021, approximately $139 million of the one-time costs are recorded in Selling, general and administrative expenses, and approximately $27 million are recorded in Cost of goods sold. For the nine months ended September 30, 2020, $30 million of one-time costs are classified in Selling, general and administrative expenses.

 

(3)Costs represent upfront licensing payment associated with ObsEva of $25 million during the third quarter 2021, which was recorded in Research and development expense.

 

 

 

TABLE 6

 

Organon & Co.

Reconciliation of GAAP Net Income to Non-GAAP Adjusted Net Income

($ in millions, except per share amounts)

 

   Three Months Ended September 30,   Nine Months Ended September 30, 
   2021   2020   2021   2020 
Net income from continuing operations before income tax  $389   $681   $1,293   $2,227 
Adjustments:                    
Amortization(1)   27    23    69    65 
Restructuring costs   1    12    3    43 
One-time costs(2)   56    7    171    30 
Acquired in-process research and development(3)   25        25     
Stock-based compensation   15    11    44    32 
Total Adjustments   124    53    312    170 
Non-GAAP pre-tax income from continuing operations   513    734    1,605    2,397 
Taxes on income as reported in accordance with GAAP   66    121    144    347 
Tax benefit on adjustments   23    9    58    22 
Tax benefit on GAAP-only discrete items(4)           91     
Non-GAAP adjusted taxes on income   89    130    293    369 
Non-GAAP adjusted net income, continuing operations   424    604    1,312    2,028 
Non-GAAP adjusted net income, continuing operations per diluted share  $1.67   $2.38   $5.17   $8.00 

 

(1)Amortization in all periods is included in Cost of goods sold.

 

(2)One-time costs primarily include cost incurred in connection with the spin-off of Organon as well as $23 million of costs incurred in June 2021 pertaining to the Alydia acquisition. For the three months ended September 30, 2021, approximately $35 million of the one-time costs are recorded in Selling, general and administrative expenses, and approximately $17 million are recorded in Cost of goods sold. For the three months ended September 30, 2020, $7 million of the one-time costs are classified in Selling, general and administrative expenses. For the nine months ended September 30, 2021, approximately $139 million of the one-time costs are recorded in Selling, general and administrative expenses, and approximately $27 million are recorded in Cost of goods sold. For the nine months ended September 30, 2020, $30 million of one-time costs are classified in Selling, general and administrative expenses.

 

(3)Costs represent upfront licensing payment associated with ObsEva of $25 million during the third quarter 2021, which was recorded in Research and development expense.

 

(4)For the three months ended June 30, 2021, the company recorded a tax benefit of approximately $70 million related to a portion of non-US step up in tax basis as a result of its separation from Merck.