EX-99.2 3 tm2427187d1_ex99-2.htm EXHIBIT 99.2

譲渡異議申立書 99.2

2024年第3四半期決算 Organon

 

 

免責事項声明 前向きな声明に関する注意事項 歴史的な情報を除く、このプレゼンテーションには、1995年の米国民事訴訟改革法の安全港規定の意味での「前向きな声明」が含まれており、Organonの将来の財務業績や見通しに関する経営陣の期待、2024年の通年ガイダンス見積もりやその他の財務情報や指標、今後のフランチャイズや製品のパフォーマンスおよび戦略に関する予測などが含まれています。前向きな声明は、「will」、「pursuing」、「expects」、「intends」、「plans」、「believes」、「seeks」、「estimates」、「will」などの言葉によって特定されることがあります。 これらの声明は、現在の経営陣の信念と期待に基づいており、重大なリスクと不確実性の対象となっています。基本となる仮定が不正確であるか、リスクや不確実な要素が実現した場合、前向きな声明に記載された結果と大きく異なる可能性があります。リスクおよび不確実性には、世界的な価格競争圧力、マネージドケアグループのルールや慣行、メディケア、メディケイド、ヘルスケア改革に関連する司法の決定や政府の法律、製薬品の償還や一般的な価格設定などが挙げられます。アメリカ、ヨーロッパ、および国際的に商品開発および商品化計画を十分に実行できない; いかなる失敗も、産業全体の高度に割引されたチャネルへのトレンドへの適応である。また、Organonの買収戦略の実施や実行が困難である、そのような買収(特に最近のDermavant Sciences Ltd.の買収)の統合が困難である、またはそのような買収の利益を認識できない失敗がある可能性があります。税法の変更やその他の税務ガイダンスの変更が現金税負担、有効税率、運用利益を不利にする可能性があり、監査の厳格な審査を受ける可能性があります。会社が活動する市場でのブランドやクラスの競争の拡大; 世界的な緊張が広範囲にわたるグローバル経済環境に混乱をもたらす可能性があります; 中国などで特に広告活動に不利な政府イニシアチブ; 当社の株価の変動; 政治および社会的圧力、または需要、入手可能性、および避妊または不妊製品への患者のアクセスに不利な影響を与える規制当局と彼らのルールメイキングに影響を与える最高裁判所の判決など、改革; および関連する金融市場の反応、税制計画、および国際貿易慣行に影響を与える2024年のアメリカ大統領選挙の影響、女性とそのヘルスケアの選択肢に影響を及ぼす可能性がある金融結果につながる、候補者のヘルスケアに関する項目、および選挙後に関連する法律、規制、および政策に可能な影響; セリングコストや販促費の増加の影響; およびOrganonの情報技術システムまたは第三者の情報技術システムに影響を及ぼす可能性があるサイバー攻撃やその他のイベントの影響に関するリスク。会社は、新しい情報、将来の出来事、またはその他の理由により、前向きな声明を公に更新する義務を負いません。前向きな声明に記載された内容と大きく異なる結果を引き起こす追加要因は、SEC(米国証券取引委員会)の書類に記載されている可能性があります。変わることができる。会社の最新の年次報告書(Form 10-K)およびその後のSEC提出書類は、SECのインターネットサイト(www.sec.gov)で入手できます。2

 

 

免責声明、続き。 非GAAP財務指標に関する注意事項 このプレゼンテーションには「非GAAP財務指標」と呼ばれる財務指標が含まれており、これは米国一般会計原則(GAAP)に準拠して計算および提示される最も直接的に比較可能な指標から除外または含まれない金額を除外または含む財務指標を指します。 具体的には、当社は非GAAP財務指標である調整後のEBITDA、調整後のEBITDA率、調整後の粗利率、調整後の粗利益、調整後の当期純利益、および調整後の希釈されたepsを利用していますが、これらはGAAPの下で認識される用語ではなく、当社のGAAP財務諸表に追加情報としてのみ提示されます。 このプレゼンテーションには、外国為替の影響を除外した特定の指標も提供されています。 通貨に関して、当社は、前期の平均通貨レートを使用して現時点の現地通貨の財務結果を換算し、これらの調整された金額を現時点の結果と比較して外国為替を計算しています。 当社は、これらの非GAAP財務指標が当社の財務業績を理解するのに役立つと考えています。 しかし、これらの指標の提示には分析ツールとしての限界があり、単独でまたはGAAPに報告された企業の結果の代替として考慮すべきではありません。 すべての企業が同一の計算を使用しているわけではないため、これらの非GAAP指標の提示は他の企業の同様に題された指標と比較できない場合があります。 このプレゼンテーションの追加情報は、該当する定義や当該非GAAP財務指標とGAAP指標との直接比較を含む20〜22ページを参照してください。 さらに、2024年の通期予測目標(売上高を除く)は、特定の項目を合理的に予測できないため、その会計処理を含むGAAP指標で提供されています。 これらの項目には、取得関連費用、再編および関連費用、株式ベースの報酬、訴訟の最終結果、異例の利益と損失、GAAP税の影響を与える事項、および当該企業の継続的な運営活動とは異なるその他の項目などが含まれます。 当社の経営陣は、上記の非GAAP財務指標を使用して、企業のパフォーマンスを評価し、運営および財務上の意思決定を導くためのガイドとしています。 さらに、当社の経営陣は、特定の項目を除外したこれらの非GAAP財務指標が、その根本的なビジネスパフォーマンス、財務状態、および業績を有意義に伝達する能力を高めるのに役立つと信じています。 3 このプレゼンテーションの20〜22スライドを参照して、非GAAP指標の調整に関する対応はこちらをご覧ください。

 

 

Third quarter 2024 highlights 4 • Revenue of $1.6 billion, up 5% ex - FX • Diluted EPS of $1.38, Adjusted Diluted EPS of $0.87 • Adjusted EBITDA of $459 million, inclusive of $51 million of IPR&D and milestones See Slides 20 - 22 of this presentation for a reconciliation of non - GAAP measures.

 

 

Women's Health 5 AhR = aryl - hydrocarbon receptor agonist, PDE - 4 = phosphodiesterase 4 inhibitor, JAK = janus kinase inhibitor, IL - 4 = interleukin 4 receptor alpha antagonist Biosimilars Women's Health Proposed label vs non - steroidal treatments IL - 4 JAK PDE 4 AhR Dupixent ® 16 Weeks Opzelura ® 8 Weeks Zoryve ® 4 Weeks Eucrisa ® 4 Weeks VTAMA ® 8 Weeks Once Every 2 Weeks - Once Every 4 Weeks Subcutaneous injection Twice Daily Topical cream Short term, ≤20% Body Surface Area Once Daily Topical Cream Twice Daily Topical Ointment Once Daily Topical Cream Dosing regimen Second line Second line First line First line First line Indication >6 months >12 years >6 years >3 months >2 years Population Mod. - Severe Mild - Moderate Mild - Moderate Mild - Moderate Mild - Severe Disease severity No Yes Yes No No Limitations No Yes No No No Boxed Warning No Yes No Yes No Warnings & Precautions 36% / 38% 10% / 9% 54% / 51% 15% / 8% 32% / 29% 15% / 12% 33% / 32% 25% / 18% 45% / 46% 14% / 18% Investigator Global Assessment Score placebo 41% / 36% 12% / 10% 52% / 51% 15% / 16% 34% / 30% 21% / 12% N/A 56 % / 53% 34% / 24% Peak Pruritus placebo *Eucrisa is a trademark registered in the United States in the name of Anacor Pharmaceuticals, LLC. * Zoryve is a trademark registered in the United States in the name of Arcutis Biotherapeutics, Inc. *Opzelura is a trademark registered in the United States in the name of Incyte Holdings Corporation. *Dupixent is a trademark registered in the United States in the name of Sanofi Biotechnology. *Proposed label currently under discussion with FDA, subject to change pending regulatory feedback. * Information based on product labeling as of October 11, 2024, and does not reflect results from a head - to - head study. Differen ces exist between trial designs and subject characteristics, and caution should be exercised when comparing data across studi es.

 

 

Women’s Health Women’s Health Ex - FX VPY Act VPY 2023 YTD 2024 YTD Ex - FX VPY Act VPY Q3 - 23 Q3 - 24 Revenues $ mil 18% 17% 599 704 11% 10% 220 243 Nexplanon ® (contraception) (32)% (34)% 137 90 (45)% (45)% 43 23 NuvaRing ® (contraception) 8% 6% 97 103 (2)% (3)% 30 29 Marvelon / Mercilon (contraception) (3)% (4)% 179 171 16% 16% 54 63 Follistim AQ ® (fertility) (6)% (7)% 88 82 4% 3% 25 26 Ganirelix Acetate Injection (fertility) 40% 40% 31 43 24% 24% 13 16 Jada ® (device) 13% 12% 106 119 25% 23% 33 40 Other Women's Health products 7% 6% 1,237 1,312 6% 5% 418 440 Total Women's Health • Strong growth in Nexplanon and Fertility offset expected impact from generics of NuvaRing • Continued uptake in Jada Totals may not foot due to rounding . Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group of companies . 6

 

 

Biosimilars Biosimilars Ex - FX VPY Act VPY 2023 YTD 2024 YTD Ex - FX VPY Act VPY Q3 - 23 Q3 - 24 Revenues $ mil 4% 4% 201 210 4% 3% 69 72 Renflexis ® 15% 15% 93 107 (49)% (49)% 40 20 Ontruzant ® 39% 38% 45 63 99% 98% 13 27 Brenzys (35)% (35)% 34 22 (44)% (44)% 12 7 Aybintio NM NM 20 98 NM NM 8 40 Hadlima ® 27% 27% 394 499 17% 16% 142 165 Biosimilars 7 • Hadlima uptake continues following U.S. launch • Ontruzant performance reflects timing of tenders in Brazil and lower demand in the U.S. and Europe • Renflexis reaching mature part of lifecycle Totals may not foot due to rounding . Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group of companies .

 

 

Established Brands Established Brands Ex - FX VPY Act VPY 2023 YTD 2024 YTD Ex - FX VPY Act VPY Q3 - 23 Q3 - 24 Revenues $ mil (7)% (9)% 1,139 1,039 (5)% (7)% 354 331 Cardiovascular (1)% (4)% 790 761 (4)% (5)% 248 237 Respiratory 11% 9% 595 652 5% 4% 210 218 Non - Opioid Pain, Bone & Derm 15% 13% 408 462 36% 35% 123 166 Other 1% (1)% 2,932 2,915 3% 2% 935 951 Total Est. Brands 8 • New migraine products and recovery in injectable steroids offset unfavorable pricing in Japan • Expect flat performance for the franchise in 2024 ex - FX Totals may not foot due to rounding .

 

 

+4% as reported, and +5% at constant currency $ mil 9 Volume growth offsets price erosion; minimal LOE and VBP impact (1) LOE = Loss of Exclusivity (2) VBP = Volume Based Procurement (3) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ and other third parties. (3) (1) (2) ~ ~ ~ ~ ~ ~ ~(130) bps headwind

 

 

Containment of operating costs partially offset gross margin pressure Actual VPY 2023 YTD 2024 YTD Actual VPY Q3 - 23 Q3 - 24 All numbers presented on non - GAAP basis except revenue and IPR&D (1) 3% 4,665 4,811 4% 1,519 1,582 Revenue 8% 1,699 1,832 7% 568 606 Cost of sales — % 2,966 2,979 3% 951 976 Adjusted Gross profit — % 1,155 1,154 — % 392 391 Selling, general and administrative (14)% 373 321 (19)% 129 105 R&D NM 8 81 NM — 51 Acquired IPR&D and milestones 6% 381 402 21% 129 156 Total research and development including IPR&D 1% 1,495 1,510 3% 447 459 Adjusted EBITDA (2)% 3.26 3.21 — % 0.87 0.87 Adjusted diluted EPS NM (0.03) (0.25) NM — (0.16) Per share impact to diluted EPS from acquired IPR&D and milestones 63.6% 61.9% 62.6% 61.7% Adjusted Gross margin 32.0% 31.4% 29.4% 29.0% Adjusted EBITDA margin (1) See Slides 20 - 22 of this presentation for a reconciliation of non - GAAP measures to their respective GAAP measures. 10

 

 

11 YTD Sept. 2023 YTD Sept. 2024 (USD millions) $1,495 $1,510 Adjusted EBITDA (312) (292) Less: Net cash interest expense (145) (152) Less: Cash taxes (492) (297) Less: Change in net working capital (93) (76) Less: CapEx $453 $693 Free Cash Flow Before One - Time Costs (238) (137) Less: One - time spin - related costs (15) (129) Less: Other one - time costs (1) $200 $427 Free Cash Flow (2) • Timing - related improvement in YTD net working capital • Significant decline in spin - related OTC • Expect one - time spin - related costs of ~$150M for full year 2024 • Increase in Other OTC due to Restructuring, MSA Exits and Microspherix settlement On track to deliver ~$1B of free cash flow before one - time spin - related costs for full year 2024 (1) Includes cash payments associated with restructuring initiatives ($60M), planned exits from supply agreements with Merck & C o., Inc., Rahway, NJ. ($44M), and the second payment on the Microspherix settlement ($25M). (2) Free cash flow represents net cash flows provided by operating activities plus capital expenditures and the effect of exc han ge rate changes on cash and cash equivalents.

 

 

12 Net leverage ratio ~4.0x at September 30, 2024 Sep 2024 Jun 2024 Mar 2024 Dec 2023 Dec 2022 Dec 2021 $ mil 763 704 575 693 706 737 Cash and cash equivalents 8,749 8,656 8,714 8,760 8,913 9,134 Gross Debt (1) 7,986 7,952 8,139 8,067 8,207 8,397 Net Debt (1) * The definition of net debt is in the company's credit agreement and excludes unamortized fees; but includes capitalized lea se obligations. Additionally, the LTM EBITDA calculation excludes acquired IPR&D and milestone expense. (1) Debt figures are net of discounts and unamortized fees of $124 million, $105 million, $84 million, $79 million, $108 mill ion and $105 million as of December 31, 2021, December 31, 2022, December 31, 2023, March 31, 2024, June 30, 2024 and September 30, 2024, respectively.

 

 

2024 expected to be third consecutive year of revenue growth at constant currency $ mil 13 (1) LOE = Loss of Exclusivity (2) VBP = Value Based Procurement (3) Other includes manufacturing sales to Merck and other third parties. (1) (2) (3) +1.8% to +2.6% reported 3.1% to +3.8% constant currency ~(120) - (135) bps headwind to growth in 2024 ~ ~ ~ ~ ~ ~ $6,375 - $6,425

 

 

14 Mid - point of range provided October 31, 2024 Productivity, base business Dermavant Nov/Dec impact Unfavorable product mix $51 million IPR&D expense in Q3 2024 Mid - point of range provided August 6, 2024 30.5% ~10 bps ~(30) bps ~(50) bps ~(80) bps 32.0% Full Year 2024 Adjusted EBITDA range revised for IPR&D, product mix

 

 

Full Year 2024 Guidance 15 Current guidance Prior guidance as of August 6, 2024 Provided on a non - GAAP basis, except revenue $6.375 B - $6.425 B $6.250 B - $6.450 B Revenues ~61.5% 61.0% - 63.0% Adjusted gross margin $1.55B - $1.60B $1.50 B - $1.70 B SG&A $430M - $470M $400M - $500M R&D $81M* $30M IPR&D $510M - $550M $430M - $530M Total R&D 30.0% - 31.0% 31.0% - 33.0% Adjusted EBITDA margin (Non - GAAP) Unchanged ~$520M Interest Unchanged ~$130M Depreciation Unchanged 18.5% - 20.5% Effective non - GAAP tax rate Unchanged ~259M Fully diluted weighted average shares outstanding *Updated R&D expense guidance includes $51 million of IPR&D and milestone expense incurred year - to - date September 30, 2024. R&D guidance does not take into consideration a forward looking view of IPR&D and milestone expense.

 

 

Q&A

 

 

Appendix

 

 

Franchise performance Ex - FX VPY Actual VPY 2023 YTD 2024 YTD Ex - FX VPY Actual VPY Q3 2023 Q3 2024 $ mil 7% 6% 1,237 1,312 6% 5% 418 440 Women’s Health 27% 27% 394 499 17% 16% 142 165 Biosimilars 1% (1)% 2,932 2,915 3% 2% 935 951 Est. Brands (17)% (17)% 102 85 7% 4% 24 26 Other (1) 5% 3% 4,665 4,811 5% 4% 1,519 1,582 Total Revenues Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to Merck & Co., Inc., Rahway, NJ and other third parties. 18

 

 

Ex - FX VPY Actual VPY 2023 YTD 2024 YTD Ex - FX VPY Actual VPY Q3 - 23 Q3 - 24 $ mil 7% 7% 1,259 1,343 12% 11% 392 436 Europe and Canada 8% 8% 1,067 1,156 8% 8% 370 398 United States (3)% (7)% 869 806 (6)% (8)% 284 260 Asia Pacific and Japan 16% 12% 687 768 5% 2% 239 243 Latin America, Middle East, Russia and Africa (2)% (4)% 661 634 5% 5% 202 212 China (15)% (15)% 122 104 2% (1)% 32 33 Other (1) 5% 3% 4,665 4,811 5% 4% 1,519 1,582 Total Revenues 19 Totals may not foot due to rounding, and percentages are computed using unrounded amounts. (1) “Other” includes manufacturing sales to Merck and Co., Inc., Rahway, NJ and other third parties. ~75% of YTD sales generated ex - US Strength in EUCAN, US offsetting mandatory pricing revisions in Japan

 

 

Reconciliation of GAAP Reported to Non - GAAP Adjusted Metrics ($ in millions) 2023 YTD 2024 YTD Q3 2023 Q3 2024 $ 2,833 $ 2,819 $ 907 $ 923 GAAP Gross Profit Adjusted for: $ 30 $ 6 $ 10 $ — Spin - related costs (1) — 39 $ — $ 14 Manufacturing network costs (2) 13 13 $ 5 $ 4 Stock - based compensation 88 102 $ 29 $ 35 Amortization 2 — — — Other $ 2,966 $ 2,979 $ 951 $ 976 Adjusted Non - GAAP Gross Profit (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 22 . (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc. , R ahway NJ, US. For additional details refer to the EBITDA reconciliation on page 22 . 2023 YTD 2024 YTD Q3 2023 Q3 2024 60.7 % 58.6 % 59.7 % 58.3 % GAAP Gross Margin 2.9 % 3.3 % 2.9 % 3.4 % Total impact of Non - GAAP adjustments 63.6 % 61.9 % 62.6 % 61.7 % Adjusted Non - GAAP Gross Margin 2023 YTD 2024 YTD Q3 2023 Q3 2024 $ 1,424 $ 1,290 $ 538 $ 422 GAAP Selling, general and administrative expenses Adjusted for: $ (131) $ (79) $ (41) $ (10) Spin - related costs (1) (50) (53) (18) (17) Stock - based compensation (88) (4) (87) (4) Other $ 1,155 $ 1,154 $ 392 $ 391 Adjusted Non - GAAP Selling, general and administrative expenses (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 22 . 20

 

 

Reconciliation of GAAP Reported to Non - GAAP Adjusted Metrics ($ in millions, except per share amounts) 2023 YTD 2024 YTD Q3 2023 Q3 2024 $ 394 $ 339 $ 137 $ 111 GAAP Research and development expenses Adjusted for: (10) (5) (4) (2) Spin - related costs (1) (11) (13) (4) (4) Stock - based compensation $ 373 $ 321 $ 129 $ 105 Adjusted Non - GAAP Research and development expenses (1) Spin - related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to t he EBITDA reconciliation on page 22 . 2023 YTD 2024 YTD Q3 2023 Q3 2024 $ 477 $ 755 $ 58 $ 359 GAAP Reported Net Income Adjusted for: 133 160 44 53 Cost of sales adjustments 269 136 146 31 Selling, general and administrative adjustments 21 18 8 6 Research and development adjustments 4 23 — — Restructuring 13 14 3 4 Other expense, net (82) (276) (36) (227) Tax impact on adjustments above (1) $ 835 $ 830 $ 223 $ 226 Non - GAAP Adjusted Net Income (1) For the three months ended September 30, 2024 and 2023, the GAAP income tax rates were (73.7)% and 27.0%, respectively, the non - GAAP income tax rates were 24.7% and 20.8%, respectively. For the nine months ended September 30, 2024 and 2023, the GAAP income tax rates were (11.3)% and 16.1% , respectively, the non - GAAP income tax rates were 19.3% and 17.3%, respectively. These adjustments represent the estimated tax impacts on the reconciling items by a ppl ying the statutory rate and applicable law of the originating territory of the non - GAAP adjustments. For additional details refer to the EBITDA reconciliation on page 22 . 2023 YTD 2024 YTD Q3 2023 Q3 2024 $ 1.86 $ 2.92 $ 0.23 $ 1.38 GAAP Diluted Earnings per Share $ 1.40 $ 0.29 $ 0.64 $ (0.51) Total impact of Non - GAAP adjustments $ 3.26 $ 3.21 $ 0.87 $ 0.87 Non - GAAP Diluted Earnings per Share 21

 

 

GAAP Net Income to Adjusted EBITDA 2023 YTD 2024 YTD Q3 2023 Q3 2024 Unaudited, $ in millions $ 477 $ 755 $ 58 $ 359 Net income 88 93 32 32 Depreciation (1) 88 102 29 35 Amortization 398 388 134 126 Interest expense 92 (77) 22 (152) Tax (benefit) expense $ 1,143 $ 1,261 $ 275 $ 400 EBITDA 4 23 — — Restructuring costs 184 104 58 16 Spin - related costs (2) — 39 — 14 Manufacturing network related (3) 90 4 87 4 Other costs (4) 74 79 27 25 Stock - based compensation $ 1,495 $ 1,510 $ 447 $ 459 Adjusted EBITDA (Non - GAAP) 32.0 % 31.4 % 29.4 % 29.0 % Adjusted EBITDA margin (Non - GAAP) 22 (1) Excludes accelerated depreciation included in one - time costs. (2) Spin - related costs reflect certain costs incurred in connection with activities taken to separate Organon from Merck & Co., Inc., Rahway, NJ, US. These costs include, but are not limited to, $7 million and $32 million for the three months ended September 30, 2024 and 2023, respectively, and $47 million and $100 million for the nine months ended September 30, 2024 and 2023, respectively, for information technology infrastructure, primarily related to the implementation of a stand - alone enterprise resource planning system and redu ndant software licensing costs, as well as $6 million for the three months ended September 30, 2023 and $20 million and $20 million for the nine months ended September 30, 2024 and 2023, respectively, as sociated with temporary transition service agreements with Merck & Co., Inc., Rahway, NJ, US. (3) Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., In c., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third - party contractor costs. (4) Other costs for the three and nine months ended September 30, 2024 and 2023, respectively, include $4 million related to tra nsaction costs associated with the Dermavant transaction incurred in 2024 and $80 million related to the Microspherix legal matter incurred in 2023. As the costs described in (1) through (4) above are directly related to the separation of Organon and therefore arise from a one - time event outside of the ordinary course of the company’s operations, the adjustment of these items provide meaningful, supplemental, information that the company believes will enhance an investor's und erstanding of the company's ongoing operating performance.

 

 

Number of products 14 5 56 Women’s Health Biosimilars Established Brands Broad and diverse portfolio 23 TM TM