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Published: 2024-04-25 07:47:51 ET
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EX-99.2 3 q12024earningspresentati.htm PRESENTATION MATERIALS OF BRISTOL-MYERS SQUIBB COMPANY DATED APRIL 25, 2024 q12024earningspresentati
Q1 2024 Results April 25, 2024


 
Q1 2024 Results Not for Product Promotional Use Forward Looking Statements and Non-GAAP Financial Information 2 This presentation contains statements about Bristol-Myers Squibb Company’s (the “Company”) future financial results, plans, business development strategy, anticipated clinical trials, results and regulatory approvals that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Actual results may differ materially from those expressed in, or implied by, these statements as a result of various factors, including, but not limited to: (i) new laws and regulations, (ii) our ability to obtain, protect and maintain market exclusivity rights and enforce patents and other intellectual property rights, (iii) our ability to achieve expected clinical, regulatory and contractual milestones on expected timelines or at all, (iv) difficulties or delays in the development and commercialization of new products, (v) difficulties or delays in our clinical trials and the manufacturing, distribution and sale of our products, (vi) adverse outcomes in legal or regulatory proceedings, (vii) risks relating to acquisitions, divestitures, alliances, joint ventures and other portfolio actions and (viii) political and financial instability, including changes in general economic conditions. These and other important factors are discussed in the Company’s most recent annual report on Form 10-K and reports on Forms 10-Q and 8-K. These documents are available on the U.S. Securities and Exchange Commission’s website, on the Company’s website or from Bristol-Myers Squibb Investor Relations. No forward-looking statements can be guaranteed. In addition, any forward-looking statements and clinical data included herein are presented only as of the date hereof. Except as otherwise required by applicable law, the Company undertakes no obligation to publicly update any of the provided information, whether as a result of new information, future events, changed circumstances or otherwise. This presentation includes certain non-generally accepted accounting principles (“GAAP”) financial measures that we use to describe the Company’s performance. The non-GAAP financial measures are provided as supplemental information and are presented because management has evaluated the Company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the Company’s baseline performance, supplement or enhance management’s, analysts’ and investors’ overall understanding of the Company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods. This presentation also provides certain revenues and expenses excluding the impact of foreign exchange (“Ex-FX”). We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. Ex-FX financial measures are not accounted for according to GAAP because they remove the effects of currency movements from GAAP results. The non-GAAP information presented herein provides investors with additional useful information but should not be considered in isolation or as substitutes for the related GAAP measures. Moreover, other companies may define non-GAAP measures differently, which limits the usefulness of these measures for comparisons with such other companies. We encourage investors to review our financial statements and publicly filed reports in their entirety and not to rely on any single financial measure. An explanation of these non-GAAP financial measures and a reconciliation to the most directly comparable financial measure are available on our website at www.bms.com/investors. Also note that a reconciliation of forward-looking non-GAAP measures, including non-GAAP earnings per share (EPS), to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the Company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results.


 
Chris Boerner, PhD Board Chair and Chief Executive Officer 3 Q1 2024 Results


 
Q1 2024 Results Not for Product Promotional Use Q1 2024 overview 4 Executing productivity initiative Advanced our Pipeline Solid Commercial Performance Actions underway to increase productivity & efficiency across the organization Multiple regulatory approvals & clinical development milestones Topline growth: +5% or +6% Ex-FX* Closed Four Significant Deals No change to the underlying business outlook from February 2024 Strengthened long-term growth profile by diversifying in Oncology & expanding in Neuroscience *See “Forward-Looking Statements and Non-GAAP Financial Information”


 
Q1 2024 Results Not for Product Promotional Use 5 Research & Development1Commercial Regulatory approvals: • Breyanzi in 3L+ CLL/SLL in U.S. • Abecma in 3L+ MM in U.S. & EU • Reblozyl 1L MDS in EU & Japan Achieved multiple clinical development milestones: • Opdualag PoC in NSCLC established2 • Krazati 2L+ NSCLC (confirmatory trial) • KarXT long-term efficacy & safety data • GPRC5D CAR T in RRMM & golcadomide in NHL in registrational trials Business Development Q1 2024 Performance *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Not an exhaustive list of assets, programs, or indications; 2. Moving to registrational trial in a segment of NSCLC based on pre-specified analysis Closed key acquisitions & global licensing deal $4.4 $4.8 Q1 2023 Q1 2024 Legacy Growth +51% +76% +72% >100% $ in billions Growth Portfolio Revenues: +8% or +11% Ex-FX* YoY >100% $11.9$11.3


 
Q1 2024 Results Not for Product Promotional Use KarXT: Potential first-in-class M1/M4 agonist with multi-billion-dollar peak sales opportunities 6 • Compelling efficacy: >75% patients achieving >30% improvement in PANSS • Differentiated safety: Continued lack of weight gain, metabolic dysfunction, & extrapyramidal symptoms Differentiated profile supported by long-term data2,3,4 U.S. FDA PDUFA date September 26, 2024; Launch preparations underway 1. DRG – Clarivate, as of July 2023; 2. Kaul I, et al. SIRS 2024 (poster # F264). 3. Claxton A, et al. SIRS 2024 (oral). 4. Marcus R, et al. SIRS 2024 (poster #F74). AEs=Adverse Events, PANSS=Positive and Negative Syndrome Scale, SOC=Standard of Care Significant market opportunity • Large population: 1.6M1 adults treated for schizophrenia in the U.S. • ~70% of patients1 on current therapies not well managed • Current SOC options associated with significant AEs including serious metabolic dysfunction


 
Q1 2024 Results Not for Product Promotional Use Strengthening the Company for the Transition Period & long-term growth 7 • Identifying key assets and programs with highest potential • Streamlining decision-making & reducing management layers • Focusing R&D on higher ROI programs • Investing in highest-priority growth brands Cost savings to be reinvested in the highest potential opportunities *The Company does not reconcile forward-looking non-GAAP measures. See “Forward-Looking Statements and Non-GAAP Financial Information” Realizing internal cost savings of ~$1.5B by the end of 2025*


 
Q1 2024 Results Not for Product Promotional Use 2024 Guidance Highlights*1 Total Revenues Reported Rates Low single-digit increase affirmed Total Revenues Ex-FX Low single-digit increase affirmed Revised Non-GAAP EPS $0.40 - $0.70 Continued confidence delivering underlying growth in 2024 8 Includes (~$6.73) impact from Acquired IPR&D & dilution from recently closed transactions2 *The Company does not reconcile forward-looking non-GAAP measures. See “Forward-Looking Statements and Non-GAAP Financial Information” 1. 2024 EPS Guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items, and the impact of future Acquired IPRD charges 2. Comprised of net impact of Acquired IPR&D charge of ($6.30) mainly from Karuna Therapeutics & SystImmune and dilution for certain interest and/or operational expenses for Karuna Therapeutics (~$0.30) & RayzeBio (~$0.13)


 
David Elkins Executive Vice President and Chief Financial Officer 9 Q1 2024 Results


 
Q1 2024 Results Not for Product Promotional Use Composition of revenue is rapidly transitioning to the Growth Portfolio 10 $4.4 $4.8 $6.9 $7.1 Q1 2023 Q1 2024 Legacy Growth Growth Portfolio Other Growth Brands1 Legacy Portfolio Other Mature Brands *See “Forward-Looking Statements and Non-GAAP Financial Information”; 1. Other Growth Brands: Onureg, Inrebic, Nulojix, Empliciti, & Royalty revenues $ in billions +3% Ex-FX* +8% YoY +2% YoY +11% Ex-FX* +5% YoY, +6% Ex-FX*


 
Q1 2024 Results Not for Product Promotional Use Q1 2024 Oncology product summary 11 Opdivo: • U.S. impacted by inventory work down & timing of customer orders vs PY; continued demand growth across indications (e.g., upper GI & 1L lung) • Ex-U.S. demand growth & expanded access Opdualag: • U.S. growth driven by strong demand; achieved 25%+ market share3 in 1L melanoma • Focused on driving share from PD-1 mono (<15%), dual I-O, & BRAF/MEK settings Krazati: • Pro forma full quarter global sales ~$27M including ~$25M in U.S. • Focused on driving 2L+ NSCLC demand • Priority Review U.S. PDUFA in 3L+ CRC: June 21, 2024 Global Net Sales *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Represents BMS sales since closure of Mirati acquisition on January 23, 2024; 2. U.S. Priority Review PDUFA June 15, 2024 (NTRK); U.S. approval Nov 2023; application under review in EU (ROS1+/NTRK) & Japan (ROS1+) 3. BMS Internal Analysis $M YoY % Ex-FX* % $2,078 (6%) (2%) $583 +15% +18% $217 (9%) (3%) $206 +76% +76% $21 --- --- $6 --- ---2 1


 
Q1 2024 Results Not for Product Promotional Use Q1 2024 Cardiovascular product summary 12 Eliquis: Best-in-class & leading OAC within category • U.S. growth driven by strong underlying demand • Ex-U.S. continues to be #1 OAC in key international markets Camzyos: First-in-class myosin inhibitor • Strong increase in total treated & commercial dispensed patients; Q1 net sales impacted by inventory & gross-to-net dynamics ‒ Momentum strengthening in new patient starts • International expansion based on reimbursement timing Global Net Sales % $M YoY % Ex-FX* % $3,720 +9% +9% $84 ** ** As of Dec 31, 2023 Mar 31, 2024 Patients in hub1 ~6,100 ~7,500 Patients on commercial drug1 ~4,500 ~5,600 *See “Forward-Looking Statements and Non-GAAP Financial Information”; **In excess of 100%; 1. BMS internal analysis & patient figures are U.S. only


 
Q1 2024 Results Not for Product Promotional Use Q1 2024 Hematology product summary 13 Reblozyl: • Strong U.S. launch in 1L MDS-associated anemia • Growth across a broad RS agnostic patient population, gaining momentum in the RS negative population • EU 1L approval with a broad label Breyanzi: • U.S. approval in 3L+ CLL/SLL • Tailwinds expected from Q2 onwards from additional manufacturing capacity & expanded indications Abecma: • KarMMa-3 approval expands the addressable patient population into earlier lines • U.S. & EU approval in 3L+ MM 1 $M YoY % Ex-FX* % $1,669 (5%) (4%) $865 +4% +4% $374 (13%) (11%) $354 +72% +72% $107 +51% +51% $82 (44%) (44%) Global Net Sales *See “Forward-Looking Statements and Non-GAAP Financial Information”


 
Q1 2024 Results Not for Product Promotional Use Q1 2024 Immunology product summary 14 Sotyktu: First-in-class TYK2 inhibitor • Achieved goal of ~10K commercial scripts in Q1 • Additional momentum driven by continued volume growth and access improvement • Continued focus on demand growth and access improvements Global Net Sales *See “Forward-Looking Statements and Non-GAAP Financial Information”; **In excess of +100%; 1. Symphony METYS TRx Data for U.S. paid scripts Q2’23 Q3’23 Q4’23 Q1’24 ~4,400 ~6,500 ~8,700 ~9,800 Sotyktu Commercially Paid Scripts1 % $M YoY % Ex-FX* % $798 +4% +6% $110 +41% +41% $44 ** **


 
Q1 2024 Results Not for Product Promotional Use US GAAP Non-GAAP $ in billions, except EPS Q1 2024 Q1 2023 Q1 2024 Q1 2023 Total Revenues, net 11.9 11.3 11.9 11.3 Gross Margin % 75.3% 77.4% 75.5% 77.8% Operating Expenses1 5.1 4.1 4.3 4.0 Acquired IPR&D 12.9 0.1 12.9 0.1 Amortization of Acquired Intangibles 2.4 2.3 - - Effective Tax Rate (3.4%) 18.2% (9.0%) 15.5% Diluted EPS (5.89) 1.07 (4.40) 2.05 Diluted Shares Outstanding (# in millions) 2,023 2,113 2,023 2,113 Q1 2024 Financial Performance 15 US P Non- P* Diluted EPS Impact from Acquired IPR&D2 (6.30) (0.01) (6.30) (0.01) *See “Forward-Looking Statements and Non-GAAP Financial Information”; 1. Operating Expenses = MS&A and R&D; 2. Represents the net impact from Acquired IPRD & Licensing income reported through Q1


 
Q1 2024 Results Not for Product Promotional Use Strategic approach to Capital Allocation 16 *Cash includes cash, cash equivalents and marketable debt securities; **Subject to Board approval $B Q1 2024 Total Cash* ~$10.0 Total Debt ~$55.7 • Prioritize opportunities to further diversify portfolio & strengthen long-term outlook focused mainly on bolt-ons & licensing opportunities ‒ Completed acquisitions of Mirati Therapeutics, Karuna Therapeutics & RayzeBio • Maintain strong investment-grade credit rating • Planned debt pay down of ~$10B over 2 years Business Development Balance Sheet Strength Returning Cash to Shareholders • Continued annual dividend growth** • ~$5B in share repurchase authorization remaining as of March 31, 2024 Strong operating cash flow generation $3.0 $1.9 $4.8 $4.3 $2.8 Q1 2023 Q2 2023 Q3 2023 Q4 2023 Q1 2024 Cash flow from Operations $B


 
Q1 2024 Results Not for Product Promotional Use Actions to enhance productivity 17 Realizing internal cost savings of ~$1.5B by the end of 2025* Strengthening the Company to navigate the Transition Period & Drive Long-Term Growth Cost savings to be reinvested in the highest potential opportunities Cost savings across the organization that include: • Reduction of management layers • ~2,200 employees impacted in 2024 • Pipeline rationalization • Site consolidation • Reduced third-party spend • Optimize operations across the organization • Prioritize investment in key growth brands • Focus on opportunities with the highest potential ROI to drive long-term growth *The Company does not reconcile forward-looking non-GAAP measures. See “Forward-Looking Statements and Non-GAAP Financial Information”


 
Q1 2024 Results Not for Product Promotional Use 2024 Non-GAAP EPS guidance adjusted for impact of recently closed transactions 18 February Diluted EPS (Prior) $7.10 - $7.40 Acquired IPR&D Impact ($6.30) Dilution Impact (RayzeBio) ($0.13) Dilution Impact (Karuna) ($0.30) Total Deals Impact ($6.73) Revised Diluted EPS1,2 $0.40 - $0.70 2024 Non-GAAP EPS Guidance* Reflects consistent underlying outlook for 2024 *The Company does not reconcile forward-looking non-GAAP measures. See “Forward-Looking Statements and Non-GAAP Financial Information” 1. 2024 EPS Guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items, and the impact of future Acquired IPRD charges 2. Comprised of net impact of Acquired IPR&D charge of ($6.30) primarily from Karuna Therapeutics & SystImmune and dilution for certain interest and/or operational expenses for Karuna Therapeutics (~$0.30) & RayzeBio (~$0.13)


 
Q1 2024 Results Not for Product Promotional Use February (Prior) April (Revised) Total Revenues Reported Rates Low single-digit increase No Change Total Revenues Ex-FX Low single-digit increase No Change Gross Margin % ~74% No Change Operating Expenses1 Low single-digit increase No Change Other Income/(Expense) ~$250M ~($250M) Tax Rate ~17.5% ~69% Diluted EPS2 $7.10 - $7.40 $0.40 - $0.70 Revised 2024 Guidance 19 Non-GAAP* *The Company does not reconcile forward-looking non-GAAP measures. See "Forward-Looking Statements and Non-GAAP Financial Information”; 1. Operating Expenses = MS&A and R&D, excluding Acquired IPR&D and Amortization of acquired intangibles; 2. April 2024 EPS Guidance comprised of Acquired IPR&D charge of (~$6.30) mainly from Karuna Therapeutics & SystImmune and dilution for certain interest and/or operational expenses for Karuna Therapeutics (~$0.30) & RayzeBio (~$0.13) and excludes the impact of any potential future strategic acquisitions, divestitures, specified items, and the impact of future Acquired IPRD charges Key Highlights • No change to Revenue or Gross Margin • No change to Operating Expenses • Other Income/(Expense) updated for financing costs of Karuna and RayzeBio • ~$13B of debt at 5.3% • Acquired IPR&D consists primarily of: • Karuna ~$12.1B • SystImmune ~$0.8B • Underlying Tax Rate excluding Acquired IPR&D: • Q1 at ~19.5% • FY’24 estimated at ~18%


 
Chris Boerner, PhD Board Chair, Chief Executive Officer David Elkins Executive VP, Chief Financial Officer Samit Hirawat, MD Executive VP, Chief Medical Officer, Global Drug Development Adam Lenkowsky Executive VP, Chief Commercialization Officer 20 Q1 2024 Results Q&A