I3 Pharmaceuticals, LLC

Sales of $10.6 billion driven by strong underlying base business performance Reported sales growth of 4.9 percent; organic sales growth for underlying base business of 8.2 percent1, led by double-digit growth in Medical DevicesContinues to strengthen portfolio with steady cadence of new product approvals, reimbursement coverage, and clinical dataABBOTT PARK, Ill., Oct. 16, 2024 /PRNewswire/ -- Abbott (NYSE: ABT) today announced financial results for the third quarter ended Sept. 30, 2024. Third-quarter GAAP diluted EPS of $0.94 and adjusted diluted EPS of $1.21, which excludes specified items.Abbott maintains its full-year 2024 organic sales growth guidance range of 9.5% to 10.0%, excluding COVID-19 testing-related sales2.Abbott now projects full-year diluted EPS on a GAAP basis of $3.34 to $3.40 and projects adjusted diluted EPS of $4.64 to $4.70, which represents an increase at the midpoint of the guidance range.In October, Abbott's board of directors authorized a new share repurchase program of up to $7 billion of the company's common shares.In August, Abbott announced a unique global partnership with Medtronic to collaborate on connecting Abbott's world-leading continuous glucose monitoring (CGM) system with Medtronic's insulin delivery devices.In September, Abbott announced the U.S. launch of Lingo™, the company's first continuous glucose monitoring system available without a prescription and designed for people interested in improving their overall health and wellness.In September, Abbott announced a partnership with the Big Ten Conference® to conduct a nationwide blood donation competition to help increase the U.S. blood supply.In September, Abbott completed enrollment ahead of schedule in its VOLT-AF IDE trial, which is designed to evaluate the Volt™ Pulsed Field Ablation (PFA) System for treating patients with heart rhythm disorders such as atrial fibrillation (AFib)."Our results this quarter demonstrate the strength of our diversified business model," said Robert B. Ford, chairman and chief executive officer, Abbott. "We're well-positioned to achieve the upper end of our initial guidance ranges for the year and have great momentum heading into next year." THIRD-QUARTER BUSINESS OVERVIEWManagement believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect® product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests. Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.  Third Quarter 2024 Results (3Q24) Sales 3Q24 ($ in millions) Total Company Nutrition Diagnostics EstablishedPharmaceuticals Medical Devices U.S. 4,202 950 1,032 — 2,216 International 6,433 1,116 1,380 1,406 2,531 Total reported 10,635 2,066 2,412 1,406 4,747 % Change vs. 3Q23 U.S. 10.1 10.4 1.8 n/a 14.2 International 1.7 (7.9) (3.8) 2.7 9.6 Total reported 4.9 (0.3) (1.5) 2.7 11.7 Impact of foreign exchange (2.5) (3.1) (2.9) (4.3) (1.6) Impact of business exit* (0.2) (0.6) — — — Organic 7.6 3.4 1.4 7.0 13.3 Impact of COVID-19 testing sales (3) (0.6) — (1.9) — — Organic (excluding COVID-19 tests) 8.2 3.4 3.3 7.0 13.3     U.S. 11.0 11.9 2.4 n/a 14.2     International 6.5 (2.6) 3.8 7.0 12.5   First Nine Months 2024 Results (9M24) Sales 9M24 ($ in millions) Total Company Nutrition Diagnostics Established Pharmaceuticals Medical Devices U.S. 11,982 2,761 2,775 — 6,435 International 18,994 3,523 4,046 3,926 7,499 Total reported 30,976 6,284 6,821 3,926 13,934 % Change vs. 9M23 U.S. 4.2 8.1 (16.2) n/a 14.3 International 3.4 (1.1) (2.4) 2.1 10.1 Total reported 3.7 2.7 (8.5) 2.1 12.0 Impact of foreign exchange (3.0) (3.1) (2.9) (7.3) (1.6) Impact of business exit and acquisition* 0.1 (0.4) — — 0.4 Organic 6.6 6.2 (5.6) 9.4 13.2 Impact of COVID-19 testing sales (3) (2.8) — (10.4) — — Organic (excluding COVID-19 tests) 9.4 6.2 4.8 9.4 13.2     U.S. 10.0 9.0 3.0 n/a 13.3     International 9.0 4.2 5.9 9.4 13.1   Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue. *Quarter to date Sept. 30, 2024, reflects the impact of discontinuing the ZonePerfect® product line in the Nutrition business in March 2024.  Year to date Sept. 30, 2024, reflects the impact of discontinuing the ZonePerfect  product line in the Nutrition business in March 2024 and the acquisition of CSI on April 27, 2023. Organic sales growth excludes the impact of the acquired business from January through April 2024.   Nutrition Third Quarter 2024 Results (3Q24) Sales 3Q24 ($ in millions) Total Pediatric Adult U.S. 950 568 382 International 1,116 387 729 Total reported 2,066 955 1,111 % Change vs. 3Q23 U.S. 10.4 12.2 7.9 International (7.9) (21.6) 1.5 Total reported (0.3) (4.5) 3.6 Impact of foreign exchange (3.1) (1.8) (4.4) Impact of business exit* (0.6) — (1.1) Organic 3.4 (2.7) 9.1     U.S. 11.9 12.2 11.5     International (2.6) (18.0) 8.0   Worldwide Nutrition sales decreased 0.3 percent on a reported basis and increased 3.4 percent on an organic basis in the third quarter, led by growth in Adult Nutrition. In Adult Nutrition, global sales increased 3.6 percent on a reported basis and 9.1 percent on an organic basis, which was led by growth of Ensure®, Abbott's market-leading complete and balanced nutrition brand.  First Nine Months 2024 Results (9M24) Sales 9M24 ($ in millions) Total Pediatric Adult U.S. 2,761 1,646 1,115 International 3,523 1,377 2,146 Total reported 6,284 3,023 3,261 % Change vs. 9M23 U.S. 8.1 11.8 3.2 International (1.1) (6.8) 2.8 Total reported 2.7 2.5 3.0 Impact of foreign exchange (3.1) (1.6) (4.4) Impact of business exit* (0.4) — (0.7) Organic 6.2 4.1 8.1     U.S. 9.0 11.8 5.0     International 4.2 (3.6) 9.7 *Reflects the impact of discontinuing the ZonePerfect® product line. This action was initiated in March 2024.   Diagnostics Third Quarter 2024 Results (3Q24) Sales 3Q24 ($ in millions) Total Core Laboratory Molecular Point of Care RapidDiagnostics U.S. 1,032 332 37 103 560 International 1,380 982 91 43 264 Total reported 2,412 1,314 128 146 824 % Change vs. 3Q23 U.S. 1.8 4.5 (2.8) 6.0 (0.2) International (3.8) (1.5) (3.9) 0.7 (12.2) Total reported (1.5) — (3.6) 4.4 (4.4) Impact of foreign exchange (2.9) (4.3) (1.5) (0.2) (1.4) Organic 1.4 4.3 (2.1) 4.6 (3.0) Impact of COVID-19 testing sales (3) (1.9) (0.2) (3.9) — (3.4) Organic (excluding COVID-19 tests) 3.3 4.5 1.8 4.6 0.4     U.S. 2.4 4.8 4.5 6.0 (1.0)     International 3.8 4.4 0.8 1.3 2.8   As expected, Diagnostics sales growth in the third quarter was negatively impacted by year-over-year declines in COVID-19 testing-related sales3. Worldwide COVID-19 testing sales were $265 million in the third quarter of 2024 compared to $305 million in the third quarter of the prior year. Excluding COVID-19 testing-related sales, global Diagnostics sales increased 0.2 percent on a reported basis and increased 3.3 percent on an organic basis. Excluding COVID-19 testing-related sales, global Core Laboratory Diagnostics sales grew 0.1 percent on a reported basis and increased 4.5 percent on an organic basis, led by continued adoption of Abbott's Alinity® family of diagnostics systems and testing portfolios.   First Nine Months 2024 Results (9M24) Sales 9M24 ($ in millions) Total Core Laboratory Molecular Point of Care Rapid Diagnostics U.S. 2,775 969 112 308 1,386 International 4,046 2,879 272 133 762 Total reported 6,821 3,848 384 441 2,148 % Change vs. 9M23 U.S. (16.2) 5.6 (12.3) 6.6 (29.8) International (2.4) 0.3 (7.2) 4.8 (10.6) Total reported (8.5) 1.5 (8.7) 6.0 (24.0) Impact of foreign exchange (2.9) (4.8) (0.8) (0.1) (1.1) Organic (5.6) 6.3 (7.9) 6.1 (22.9) Impact of COVID-19 testing sales (3) (10.4) (0.2) (6.3) — (25.0) Organic (excluding COVID-19 tests) 4.8 6.5 (1.6) 6.1 2.1     U.S. 3.0 5.9 (3.3) 6.6 (0.1)     International 5.9 6.7 (0.9) 5.1 5.7   Established Pharmaceuticals Third Quarter 2024 Results (3Q24) Sales 3Q24 ($ in millions) Total Key EmergingMarkets Other U.S. — — — International 1,406 994 412 Total reported 1,406 994 412 % Change vs. 3Q23 U.S. n/a n/a n/a International 2.7 0.7 8.1 Total reported 2.7 0.7 8.1 Impact of foreign exchange (4.3) (4.7) (3.1) Organic 7.0 5.4 11.2     U.S. n/a n/a n/a     International 7.0 5.4 11.2   Established Pharmaceuticals sales increased 2.7 percent on a reported basis and 7.0 percent on an organic basis in the third quarter. Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott's branded generics product portfolio. Sales in these geographies increased 0.7 percent on a reported basis and increased 5.4 percent on an organic basis, led by growth in several geographies and therapeutic areas, including gastroenterology, cardiometabolic, and central nervous system/pain management.  First Nine Months 2024 Results (9M24) Sales 9M24 ($ in millions) Total Key EmergingMarkets Other U.S. — — — International 3,926 2,910 1,016 Total reported 3,926 2,910 1,016 % Change vs. 9M23 U.S. n/a n/a n/a International 2.1 0.7 6.4 Total reported 2.1 0.7 6.4 Impact of foreign exchange (7.3) (9.0) (2.2) Organic 9.4 9.7 8.6     U.S. n/a n/a n/a     International 9.4 9.7 8.6   Medical Devices Third Quarter 2024 Results (3Q24) Sales 3Q24 ($ in millions) Total Rhythm Management Electro- physiology HeartFailure Vascular StructuralHeart Neuro-modulation DiabetesCare U.S. 2,216 288 285 252 258 270 190 673 International 2,531 309 325 70 441 288 46 1,052 Total reported 4,747 597 610 322 699 558 236 1,725 % Change vs. 3Q23 U.S. 14.2 6.0 15.8 16.7 2.8 21.1 0.8 23.6 International 9.6 5.7 9.2 5.2 4.5 9.2 17.8 13.3 Total reported 11.7 5.9 12.2 14.0 3.9 14.6 3.8 17.1 Impact of foreign exchange (1.6) (1.1) (2.1) (0.4) (1.0) (1.9) (1.4) (2.0) Organic 13.3 7.0 14.3 14.4 4.9 16.5 5.2 19.1     U.S. 14.2 6.0 15.8 16.7 2.8 21.1 0.8 23.6     International 12.5 7.9 13.0 6.6 6.2 12.6 25.7 16.5   Worldwide Medical Devices sales increased 11.7 percent on a reported basis and 13.3 percent on an organic basis in the third quarter, including double-digit organic growth in both the U.S. and internationally. Sales growth was led by double-digit growth in Diabetes Care, Structural Heart, Heart Failure, and Electrophysiology. Several products contributed to the strong performance, including FreeStyle Libre®, Navitor®, TriClip®, Amplatzer® Amulet®, and AVEIR®. In Electrophysiology, sales grew 12.2 percent on a reported basis and 14.3 percent on an organic basis, which included double-digit growth in catheters and cardiac mapping-related products. In Diabetes Care, sales of continuous glucose monitors exceeded $1.6 billion and grew 19.1 percent on a reported basis and 20.7 percent on an organic basis.  First Nine Months 2024 Results (9M24) Sales 9M24 ($ in millions) Total RhythmManagement Electro- physiology HeartFailure Vascular StructuralHeart Neuro-modulation Diabetes Care U.S. 6,435 851 841 733 787 761 563 1,899 International 7,499 915 983 215 1,325 876 142 3,043 Total reported 13,934 1,766 1,824 948 2,112 1,637 705 4,942 % Change vs. 9M23 U.S. 14.3 6.4 15.3 11.0 7.4 16.7 6.5 24.3 International 10.1 4.8 12.6 8.2 4.2 10.3 16.5 13.5 Total reported 12.0 5.6 13.8 10.4 5.4 13.2 8.4 17.4 Impact of foreign exchange (1.6) (1.2) (2.6) (0.1) (1.3) (1.9) (1.5) (1.9) Impact of acquisition* 0.4 — — — 2.8 — — — Organic 13.2 6.8 16.4 10.5 3.9 15.1 9.9 19.3     U.S. 13.3 6.4 15.3 11.0 0.1 16.7 6.5 24.3     International 13.1 7.1 17.4 8.9 6.0 13.7 24.6 16.5 *Abbott completed the acquisition of CSI on April 27, 2023. For purposes of calculating organic sales growth, the impact from this acquired business has been excluded from January through April 2024.   ABBOTT'S EARNINGS-PER-SHARE GUIDANCEAbbott projects full-year 2024 diluted earnings per share under GAAP of $3.34 to $3.40. Abbott forecasts specified items for the full-year 2024 of $1.30 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $4.64 to $4.70 for the full-year 2024. Abbott projects fourth-quarter 2024 diluted earnings per share under GAAP of $0.96 to $1.02. Abbott forecasts specified items for the fourth-quarter 2024 of $0.35 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $1.31 to $1.37 for the fourth quarter 2024. ABBOTT DECLARES 403RD CONSECUTIVE QUARTERLY DIVIDENDOn Sept. 19, 2024, the board of directors of Abbott declared the company's quarterly dividend of $0.55 per share. Abbott's cash dividend is payable Nov. 15, 2024, to shareholders of record at the close of business on Oct. 15, 2024. Abbott has increased its dividend payout for 52 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years. About Abbott: Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube. Abbott will live-webcast its third-quarter earnings conference call through its Investor Relations website at www.abbottinvestor.com at 8 a.m. Central time today. An archived edition of the webcast will be available later in the day. — Private Securities Litigation Reform Act of 1995 —A Caution Concerning Forward-Looking Statements Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, "Risk Factors" in our Annual Report on Form 10-K for the year ended Dec. 31, 2023, and are incorporated herein by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 1 In the third quarter of 2024, total worldwide sales were $10.635 billion and COVID-19 testing-related sales were $265 million. In the third quarter of 2023, total worldwide sales were $10.143 billion and COVID-19 testing-related sales were $305 million. 2 Abbott has not provided the related GAAP financial measure for organic sales growth, excluding COVID-19 testing-related sales, on a forward-looking basis because the company is unable to predict with reasonable certainty the impact of foreign exchange due to the unpredictability of future changes in foreign exchange rates, which could significantly impact reported sales growth. In addition, as the COVID-19 pandemic has shifted to an endemic state, the company has determined that it is unable to predict with reasonable certainty future COVID-19 test sales due to the unpredictability of demand for COVID-19 tests. 3 Diagnostic sales and COVID-19 testing-related sales in 2024 and 2023 are summarized below:   Sales 3Q24 COVID Tests Sales 3Q24 ($ in millions) U.S. Int'l Total U.S. Int'l Total Total Diagnostics 1,032 1,380 2,412 206 59 265 Core Laboratory 332 982 1,314 1 2 3 Molecular 37 91 128 2 1 3 Rapid Diagnostics 560 264 824 203 56 259 Sales 3Q23 COVID Tests Sales 3Q23 ($ in millions) U.S. Int'l Total U.S. Int'l Total Total Diagnostics 1,013 1,436 2,449 207 98 305 Core Laboratory 317 997 1,314 2 3 5 Molecular 38 95 133 5 3 8 Rapid Diagnostics 561 301 862 200 92 292 Sales 9M24 COVID Tests Sales 9M24 ($ in millions) U.S. Int'l Total U.S. Int'l Total Total Diagnostics 2,775 4,046 6,821 428 143 571 Core Laboratory 969 2,879 3,848 3 5 8 Molecular 112 272 384 7 3 10 Rapid Diagnostics 1,386 762 2,148 418 135 553 Sales 9M23 COVID Tests Sales 9M23 ($ in millions) U.S. Int'l Total U.S. Int'l Total Total Diagnostics 3,309 4,145 7,454 1,031 267 1,298 Core Laboratory 917 2,872 3,789 6 10 16 Molecular 128 293 421 19 17 36 Rapid Diagnostics 1,975 853 2,828 1,006 240 1,246   Abbott Laboratories and Subsidiaries Condensed Consolidated Statement of Earnings Third Quarter Ended September 30, 2024 and 2023 (in millions, except per share data) (unaudited) 3Q24 3Q23 % Change Net Sales $10,635 $10,143 4.9 Cost of products sold, excluding amortization expense 4,698 4,605 2.0 Amortization of intangible assets 470 496 (5.1) Research and development 713 672 6.1 Selling, general, and administrative 2,895 2,723 6.3 Total Operating Cost and Expenses 8,776 8,496 3.3 Operating Earnings 1,859 1,647 12.8 Interest expense, net 51 69 (26.0) Net foreign exchange (gain) loss (11) (10) n/m Other (income) expense, net (121) (83) n/m Earnings before taxes 1,940 1,671 16.1 Taxes on earnings 294 235 25.6 Net Earnings $1,646 $1,436 14.6 Net Earnings excluding Specified Items, as described below $2,119 $2,000 5.9 1) Diluted Earnings per Common Share $0.94 $0.82 14.6 Diluted Earnings per Common Share, excluding Specified Items, as described below $1.21 $1.14 6.1 1) Average Number of Common Shares Outstanding Plus Dilutive Common Stock Options 1,748 1,748   NOTES: See table tilted "Non-GAAP Reconciliation of Financial Information" for an explanation of certain non-GAAP financial information. n/m = Percent change is not meaningful. See footnotes on the following section. 1) 2024 Net Earnings and Diluted Earnings per Common Share, excluding Specified Items, excludes net after-tax charges of $473 million, or $0.27 per share, for intangible amortization, charges related to intangible impairment, expenses associated with acquisitions and a divestiture, and other net expenses. 2023 Net Earnings and Diluted Earnings per Common Share, excluding Specified Items, excludes net after-tax charges of $564 million, or $0.32 per share, for intangible amortization, charges related to the impairment of R&D intangible assets, expenses associated with acquisitions, restructuring and cost reduction initiatives and other net expenses.   Abbott Laboratories and Subsidiaries Condensed Consolidated Statement of Earnings Nine Months Ended September 30, 2024 and 2023 (in millions, except per share data) (unaudited) 9M24 9M23 % Change Net Sales $30,976 $29,868 3.7 Cost of products sold, excluding amortization expense 13,764 13,419 2.6 Amortization of intangible assets 1,413 1,485 (4.9) Research and development 2,095 2,041 2.6 Selling, general, and administrative 8,790 8,225 6.9 Total Operating Cost and Expenses 26,062 25,170 3.5 Operating Earnings 4,914 4,698 4.6 Interest expense, net 170 182 (6.4) Net foreign exchange (gain) loss (17) 17 n/m Other (income) expense, net (222) (370) n/m Earnings before taxes 4,983 4,869 2.3 Taxes on earnings 810 740 9.6 1) Net Earnings $4,173 $4,129 1.0 Net Earnings excluding Specified Items, as described below $5,851 $5,708 2.5 2) Diluted Earnings per Common Share $2.38 $2.35 1.3 Diluted Earnings per Common Share, excluding Specified Items, as described below $3.33 $3.25 2.5 2) Average Number of Common Shares Outstanding Plus Dilutive Common Stock Options 1,749 1,750   NOTES: See table tilted "Non-GAAP Reconciliation of Financial Information" for an explanation of certain non-GAAP financial information. n/m = Percent change is not meaningful. See footnotes on the following section. 1) 2024 Taxes on Earnings includes the recognition of approximately $35 million of net tax expense as a result of the resolution of various tax positions related to prior years. 2023 Taxes on Earnings includes the recognition of approximately $59 million of net tax expense as a result of the resolution of various tax positions related to prior years. 2) 2024 Net Earnings and Diluted Earnings per Common Share, excluding Specified Items, excludes net after-tax charges of $1.678 billion, or $0.95 per share, for intangible amortization, charges related to intangible impairment, charges related to restructuring and cost reduction initiatives, expenses associated with acquisitions and a divestiture, and other net expenses. 2023 Net Earnings and Diluted Earnings per Common Share, excluding Specified Items, excludes net after-tax charges of $1.579 billion, or $0.90 per share, for intangible amortization, charges related to restructuring and cost reduction initiatives, expenses associated with acquisitions and other net expenses.   Abbott Laboratories and Subsidiaries Non-GAAP Reconciliation of Financial Information Third Quarter Ended September 30, 2024 and 2023 (in millions, except per share data) (unaudited) 3Q24 As Reported (GAAP) SpecifiedItems As Adjusted Intangible Amortization $            470 $          (470) $              — Gross Margin 5,467 516 5,983 R&D 713 (19) 694 SG&A 2,895 (5) 2,890 Other (income) expense, net (121) (12) (133) Earnings before taxes 1,940 552 2,492 Taxes on Earnings 294 79 373 Net Earnings 1,646 473 2,119 Diluted Earnings per Share $           0.94 $           0.27 $           1.21   Specified items reflect intangible amortization expense of $470 million and other net expenses of $82 million associated with charges related to intangible impairment, acquisitions, a divestiture and other net expenses. See table titled "Details of Specified Items" for additional details regarding specified items. 3Q23 As Reported(GAAP) SpecifiedItems As Adjusted Intangible Amortization $            496 $          (496) $              — Gross Margin 5,042 542 5,584 R&D 672 (46) 626 SG&A 2,723 (43) 2,680 Other (income) expense, net (83) (23) (106) Earnings before taxes 1,671 654 2,325 Taxes on Earnings 235 90 325 Net Earnings 1,436 564 2,000 Diluted Earnings per Share $           0.82 $           0.32 $           1.14   Specified items reflect intangible amortization expense of $496 million and other net expenses of $158 million associated with restructuring actions, costs associated with acquisitions and other net expenses. See table titled "Details of Specified Items" for additional details regarding specified items. Abbott Laboratories and Subsidiaries Non-GAAP Reconciliation of Financial Information Nine Months Ended September 30, 2024 and 2023 (in millions, except per share data) (unaudited) 9M24 As Reported(GAAP) SpecifiedItems As Adjusted Intangible Amortization $         1,413 $       (1,413) $              — Gross Margin 15,799 1,540 17,339 R&D 2,095 (81) 2,014 SG&A 8,790 (96) 8,694 Other (income) expense, net (222) (183) (405) Earnings before taxes 4,983 1,900 6,883 Taxes on Earnings 810 222 1,032 Net Earnings 4,173 1,678 5,851 Diluted Earnings per Share $           2.38 $           0.95 $           3.33   Specified items reflect intangible amortization expense of $1.413 billion and other net expenses of $487 million associated with restructuring actions, acquisitions, a divestiture and other net expenses. See table titled "Details of Specified Items" for additional details regarding specified items. 9M23 As Reported(GAAP) SpecifiedItems As Adjusted Intangible Amortization $         1,485 $       (1,485) $              — Gross Margin 14,964 1,591 16,555 R&D 2,041 (144) 1,897 SG&A 8,225 (67) 8,158 Other (income) expense, net (370) 34 (336) Earnings before taxes 4,869 1,768 6,637 Taxes on Earnings 740 189 929 Net Earnings 4,129 1,579 5,708 Diluted Earnings per Share $           2.35 $           0.90 $           3.25   Specified items reflect intangible amortization expense of $1.485 billion and other net expenses of $283 million associated with restructuring actions, costs associated with acquisitions and other expenses. See table titled "Details of Specified Items" for additional details regarding specified items. A reconciliation of the third-quarter tax rates for 2024 and 2023 is shown below: 3Q24 ($ in millions) Pre-Tax Income Taxes on Earnings Tax Rate As reported (GAAP) $         1,940 $            294 15.2 % Specified items 552 79 Excluding specified items $         2,492 $            373 15.0 % 3Q23 ($ in millions) Pre-Tax Income Taxes on Earnings Tax Rate As reported (GAAP) $         1,671 $            235 14.0 % Specified items 654 90 Excluding specified items $         2,325 $            325 14.0 %   A reconciliation of the year-to-date tax rates for 2024 and 2023 is shown below:  9M24 ($ in millions) Pre-Tax Income Taxes on Earnings Tax Rate As reported (GAAP) $         4,983 $            810 16.3 % 1) Specified items 1,900 222 Excluding specified items $         6,883 $         1,032 15.0 % 9M23 ($ in millions) Pre-Tax Income Taxes on Earnings Tax Rate As reported (GAAP) $         4,869 $            740 15.2 % 2) Specified items 1,768 189 Excluding specified items $         6,637 $            929 14.0 % 1) 2024 Taxes on Earnings includes the recognition of approximately $35 million of net tax expense as a result of the resolution of various tax positions related to prior years. 2) 2023 Taxes on Earnings includes the recognition of approximately $59 million of net tax expense as a result of the resolution of various tax positions related to prior years.   Abbott Laboratories and Subsidiaries Non-GAAP Revenue Reconciliation Third Quarter and Nine Months Ended September 30, 2024 and 2023 ($ in millions) (unaudited) 3Q24 3Q23 % Change vs. 3Q23 Non-GAAP Abbott Reported Impact frombusiness exit (b) Adjusted Revenue Abbott Reported Impact frombusiness exit (b) Adjusted Revenue Reported Adjusted Organic Total Company 10,635 (5) 10,630 10,143 (17) 10,126 4.9 5.1 7.6 U.S. 4,202 (5) 4,197 3,817 (17) 3,800 10.1 10.4 10.4 Intl 6,433 — 6,433 6,326 — 6,326 1.7 1.7 5.8 Total Nutrition 2,066 (5) 2,061 2,073 (17) 2,056 (0.3) 0.3 3.4 U.S. 950 (5) 945 860 (17) 843 10.4 11.9 11.9 Intl 1,116 — 1,116 1,213 — 1,213 (7.9) (7.9) (2.6) Adult Nutrition 1,111 (5) 1,106 1,072 (17) 1,055 3.6 4.7 9.1 U.S. 382 (5) 377 354 (17) 337 7.9 11.5 11.5 Intl 729 — 729 718 — 718 1.5 1.5 8.0 Total Medical Devices 4,747 — 4,747 4,249 — 4,249 11.7 11.7 13.3 U.S. 2,216 — 2,216 1,940 — 1,940 14.2 14.2 14.2 Intl 2,531 — 2,531 2,309 — 2,309 9.6 9.6 12.5 Vascular 699 — 699 672 — 672 3.9 3.9 4.9 U.S. 258 — 258 251 — 251 2.8 2.8 2.8 Intl 441 — 441 421 — 421 4.5 4.5 6.2   9M24 9M23 % Change vs. 9M23 Non-GAAP Abbott Reported Impact of acquisition (a) Impact frombusiness exit (b) AdjustedRevenue AbbottReported Impact frombusiness exit (b) AdjustedRevenue Reported Adjusted Organic Total Company 30,976 (57) (13) 30,906 29,868 (32) 29,836 3.7 3.6 6.6 U.S. 11,982 (53) (13) 11,916 11,503 (32) 11,471 4.2 3.9 3.9 Intl 18,994 (4) — 18,990 18,365 — 18,365 3.4 3.4 8.3 Total Nutrition 6,284 — (13) 6,271 6,116 (32) 6,084 2.7 3.1 6.2 U.S. 2,761 — (13) 2,748 2,553 (32) 2,521 8.1 9.0 9.0 Intl 3,523 — — 3,523 3,563 — 3,563 (1.1) (1.1) 4.2 Adult Nutrition 3,261 — (13) 3,248 3,167 (32) 3,135 3.0 3.7 8.1 U.S. 1,115 — (13) 1,102 1,081 (32) 1,049 3.2 5.0 5.0 Intl 2,146 — — 2,146 2,086 — 2,086 2.8 2.8 9.7 Total Medical Devices 13,934 (57) — 13,877 12,444 — 12,444 12.0 11.6 13.2 U.S. 6,435 (53) — 6,382 5,631 — 5,631 14.3 13.3 13.3 Intl 7,499 (4) — 7,495 6,813 — 6,813 10.1 10.0 13.1 Vascular 2,112 (57) — 2,055 2,004 — 2,004 5.4 2.6 3.9 U.S. 787 (53) — 734 733 — 733 7.4 0.1 0.1 Intl 1,325 (4) — 1,321 1,271 — 1,271 4.2 3.9 6.0 (a) Abbott completed the acquisition of CSI on April 27, 2023. For purposes of calculating organic sales growth, the impact from this acquired business has been excluded from January through April 2024. (b) Reflects the impact of discontinuing the ZonePerfect® product line in the Nutrition business. This action was initiated in March 2024.   Abbott Laboratories and Subsidiaries Details of Specified Items Third Quarter Ended September 30, 2024 (in millions, except per share data) (unaudited) Acquisition or Divestiture- related (a) Restructuring and Cost Reduction Initiatives (b) Intangible Amortization Other (c) Total Specifieds Gross Margin $                  — $                    2 $                470 $                  44 $                516 R&D — — — (19) (19) SG&A (7) 2 — — (5) Other (income) expense, net (5) — — (7) (12) Earnings before taxes $                  12 $                  — $                470 $                  70 552 Taxes on Earnings (d) 79 Net Earnings $                473 Diluted Earnings per Share $               0.27 The table above provides additional details regarding the specified items described on tables titled "Non-GAAP Reconciliation of Financial Information." a) Acquisition-related expenses include integration costs, which represent incremental costs directly related to integrating acquired businesses. b) Restructuring and cost reduction initiative expenses include severance, outplacement and other direct costs associated with specific restructuring plans and cost reduction initiatives. c) Other includes incremental costs to comply with the European Union's Medical Device Regulations (MDR) and In Vitro Diagnostics Medical Device Regulations (IVDR) requirements for previously approved products and investment and intangible asset impairment charges. d) Reflects the net tax benefit associated with the specified items.   Abbott Laboratories and Subsidiaries Details of Specified Items Third Quarter Ended September 30, 2023 (in millions, except per share data) (unaudited) Acquisition or Divestiture- related (a) Restructuring and Cost Reduction Initiatives (b) Intangible Amortization Other (c) Total Specifieds Gross Margin $                    3 $                  19 $                496 $                  24 $                542 R&D (1) (13) — (32) (46) SG&A (22) (22) — 1 (43) Other (income) expense, net 5 — — (28) (23) Earnings before taxes $                  21 $                  54 $                496 $                  83 654 Taxes on Earnings (d) 90 Net Earnings $                564 Diluted Earnings per Share $               0.32 The table above provides additional details regarding the specified items described on tables titled "Non-GAAP Reconciliation of Financial Information." a) Acquisition-related expenses include integration costs, which represent incremental costs directly related to integrating acquired businesses, as well as legal and other costs related to business acquisitions. b) Restructuring and cost reduction initiative expenses include severance, outplacement and other direct costs associated with specific restructuring plans and cost reduction initiatives. c) Other includes incremental costs to comply with the European Union's Medical Device Regulations (MDR) and In Vitro Diagnostics Medical Device Regulations (IVDR) requirements for previously approved products and charges for intangible asset impairments. d) Reflects the net tax benefit associated with the specified items.   Abbott Laboratories and Subsidiaries Details of Specified Items Nine Months Ended September 30, 2024 (in millions, except per share data) (unaudited) Acquisition or Divestiture- related (a) Restructuring and Cost Reduction Initiatives (b) Intangible Amortization Other (c) Total Specifieds Gross Margin $                    2 $                  76 $             1,413 $                  49 $             1,540 R&D (4) (1) — (76) (81) SG&A (32) (17) — (47) (96) Other (income) expense, net (140) — — (43) (183) Earnings before taxes $                178 $                  94 $             1,413 $                215 1,900 Taxes on Earnings (d) 222 Net Earnings $             1,678 Diluted Earnings per Share $               0.95 The table above provides additional details regarding the specified items described on tables titled "Non-GAAP Reconciliation of Financial Information." a) Includes the loss on the sale of a non-core business. Acquisition-related expenses include integration costs, which represent incremental costs directly related to integrating acquired businesses, as well as other costs related to business acquisitions. b) Restructuring and cost reduction initiative expenses include severance, outplacement and other direct costs associated with specific restructuring plans and cost reduction initiatives. c) Other includes incremental costs to comply with the MDR and IVDR regulations for previously approved products and charges for investment and intangible asset impairments. d) Reflects the net tax benefit associated with the specified items and tax expense as a result of the resolution of various tax positions related to prior years.   Abbott Laboratories and Subsidiaries Details of Specified Items Nine Months Ended September 30, 2023 (in millions, except per share data) (unaudited) Acquisition or Divestiture- related (a) Restructuring and Cost Reduction Initiatives (b) Intangible Amortization Other (c) Total Specifieds Gross Margin $                  15 $                  51 $             1,485 $                  40 $             1,591 R&D (13) (5) — (126) (144) SG&A (43) (28) — 4 (67) Other (income) expense, net 46 — — (12) 34 Earnings before taxes $                  25 $                  84 $             1,485 $                174 1,768 Taxes on Earnings (d) 189 Net Earnings $             1,579 Diluted Earnings per Share $               0.90 The table above provides additional details regarding the specified items described on tables titled "Non-GAAP Reconciliation of Financial Information." a) Acquisition-related expenses include legal and other costs related to business acquisitions as well as integration costs, which represent incremental costs directly related to integrating acquired businesses. b) Restructuring and cost reduction initiative expenses include severance, outplacement and other direct costs associated with specific restructuring plans and cost reduction initiatives. c) Other includes incremental costs to comply with the MDR and IVDR regulations for previously approved products and charges for intangible asset impairments. d) Reflects the net tax benefit associated with the specified items and tax expense as a result of the resolution of various tax positions related to prior years.   SOURCE Abbott

October 1, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces the positive outcome of the LIONHEART study, confirming vamorolone’s distinctive action also as a mineralocorticoid receptor antagonist, setting it apart from other corticosteroids. The LIONHEART study, an open-label randomized, placebo- and eplerenone-controlled study involving 30 healthy adult male subjects, met its primary endpoint. It demonstrated a statistically significant increase in the urinary sodium/potassium ratio in the vamorolone arm compared to placebo (p<0.0001) following a fludrocortisone challenge. This increased ratio in urine provides clinical evidence for vamorolone’s unique mode of action also as a mineralocorticoid receptor antagonist (MRA) in humans. Combined with its known properties as a dissociative glucocorticoid receptor agonist, these findings further differentiate vamorolone’s pharmacological profile, distinguishing it from other corticosteroids. Cardiac complications such as cardiomyopathy are a leading cause of morbidity and mortality in boys with Duchenne muscular dystrophy (DMD). While treatment with corticosteroids (and ACE inhibitors) has demonstrated a delay in the onset of cardiomyopathy, the addition of MRAs including eplerenone to standard of care has also shown an improvement in left ventricular systolic dysfunction, the benefit of which increases with earlier initiation [1-3]. “Mineralocorticoid receptor antagonists are strongly recommended but late when cardiac function is already reduced and tend to be used in the presence of myocardial fibrosis as detected in magnetic resonance imaging,” explained Prof Karim Wahbi, PhD, MD, Cardiologist at the APHP Hospital Cochin, Paris, France. “What is intriguing about this mechanistic study is whether there is a synergistic benefit of the anti-inflammatory and MRA effects of vamorolone on the evolution of cardiac disease in children who started treatment early or if vamorolone could be of benefit to those who are already experiencing cardiac symptoms and wish to remain on a corticosteroid” “The LIONHEART study is an important milestone to establish the proof of concept for a cardioprotective potential of vamorolone,” stated Shabir Hasham, MD, Chief Medical Officer of Santhera. “We continue to collect data from patients who have been on vamorolone for up to seven years allowing us to better characterize long-term outcomes including any beneficial impact on cardiac complications in DMD.” AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity. Moreover, it is not a substrate for the 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes that may be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues [4-7]. This mechanism has shown the potential to ‘dissociate’ efficacy from steroid safety concerns and therefore AGAMREE is positioned as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD [4-7]. In the pivotal VISION-DMD study, AGAMREE met the primary endpoint Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment and showed a good safety and tolerability profile [4]. The most commonly reported side effects were cushingoid features, vomiting, weight increase and irritability. Side effects were generally of mild to moderate severity. Currently available data show that AGAMREE, unlike corticosteroids, has been shown to be a dual mineralocorticoid antagonist and a dissociative glucocorticoid agonist based on animal experiments [7]. It has no restriction of growth [8] and no negative effects on bone metabolism as demonstrated by normal bone formation and bone resorption serum markers [9]. AGAMREE (vamorolone), an orphan medicinal product, is approved for use in the United States (Prescribing Information), the European Union (Summary of Product Characteristics) and the United Kingdom for the treatment of DMD. The LIONHEART study (SNT-I-VAM-026) is an open label randomized, 3-arm, parallel-group, placebo and eplerenone controlled study to evaluate the mineralocorticoid receptor antagonism (MRA) effect of vamorolone in 30 healthy adult male subjects after challenge with fludrocortisone, a known mineralocorticoid receptor agonist. The primary endpoint was defined as the ratio of sodium to potassium (Na/K) and the corresponding logarithm of the ratio (log10(10*Na/K) in urine at different time-points. Further analysis of the data is ongoing and will be presented at medical conferences. References: [1] Birnkrant et al. (2018) Lancet Neurol. 2018 Apr;17(4):347-361. doi: 10.1016/S1474-4422(18)30025-5. [2] Raman et a. (2015) Lancet Neurol 14: 153–161 doi:10.1016/s1474-4422(14)70318-7 [3] Raman et al. (2017) Orphanet J Rare Dis 12: 39. doi:10.1186/s13023-017-0590-8 [4] Dang UJ et al. (2024) Neurology 2024;102:e208112. doi.org/10.1212/WNL.0000000000208112. Link. [5] Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link. [6] Liu X et al (2020). Proc Natl Acad Sci USA 117:24285-24293 [7] Heier CR et al (2019). Life Science Alliance DOI: 10.26508 [8] Ward et al., WMS 2022, FP.27 - Poster 71. Link. [9] Hasham et al., MDA 2022 Poster presentation. Link. Duchenne muscular dystrophy (DMD) is a rare inherited X-chromosome-linked disease, which almost exclusively affects males. DMD is characterized by inflammation which is present at birth or shortly thereafter. Inflammation leads to fibrosis of muscle and is clinically manifested by progressive muscle degeneration and weakness. Major milestones in the disease are the loss of ambulation, the loss of self-feeding, the start of assisted ventilation, and the development of cardiomyopathy. DMD reduces life expectancy to before the fourth decade due to respiratory and/or cardiac failure. Corticosteroids are the current standard of care for the treatment of DMD. Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE® (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Medicines Agency (EMA), and in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Santhera has out-licensed rights to AGAMREE for North America to Catalyst Pharmaceuticals and for China to Sperogenix Therapeutics. For further information, please visit www.santhera.com. The content above comes from the network. if any infringement, please contact us to modify.

Industry veteran Doug Williams is back with a new approach to CAR-T cell therapies that he expects to take into the clinic in the US by year’s end. After a brief stint at Sana Biotechnology , leaving his R&D chief post in the spring, Williams is returning to the role of CEO at a little-known biotech. In recent weeks, he took the top spot at China-born and now California-headquartered biotech TriArm Therapeutics . It’s a position he held at Codiak BioSciences , a startup that tried turning exosomes into medicines, but the relatively nascent idea couldn’t survive on the public markets in 2023. Now, he’s driving TriArm’s mission to “democratize” CAR-T cell therapies using what it calls a “fast-in-time” (FIT) and non-viral manufacturing process, Williams told Endpoints News . He said TriArm’s technology platform has led to a two-day manufacturing process. “There’s also some potential advantages to cell fitness, the actual fitness of the CAR, the composition of cells that we’re reinfusing back into the patient,” Williams said. “We’re preserving a population of cells using this FIT process that may end up being more fit from a biologic perspective because they’re enriched in STEM and naïve T cells,” he added. TriArm has been relatively quiet since launching in 2019. Its financial backers include Panacea Venture , MSD Capital and Lombard Odier , and it employs about 100 people across Shanghai, Taipei and San Mateo, CA. The company aims to speed up the testing of CAR-T therapies and make faster go/no-go R&D decisions by employing an investigator-initiated model in China and then moving into clinical studies in the US, Williams said. “As somebody that is a drug developer by choice and by training, to be able to get a glimpse of what is arguably real data in a population of patients as sort of a preamble to filing an IND and really moving ahead in larger, much more expensive trials, it’s a fantastic setup to have available,” Williams said. Its first US-based trial, testing a CD19-directed autologous therapy, is slated to start later this year, Williams said. A gene therapy could soon enter a similar patient setting with the emergence this week of a new biotech called Vironexis . — Kyle LaHucik → Biogen ’s board continues to evolve under chair Caroline Dorsa , who replaced Stelios Papadopoulos last year. On Jan. 1, ex- AstraZeneca BioPharmaceuticals R&D chief Mene Pangalos will take a seat on the board, and Lloyd Minor — the dean of Stanford University’s School of Medicine — will become a board member much earlier on Oct. 1. After the hubbub surrounding the departure of board member Alex Denner and the appointment of his romantic partner Susan Langer in June 2023, Biogen then elected ex- 3M president and CFO Monish Patolawala to the board in November. Richard Mulligan and William Jones also left the board last year. Pangalos retired from AstraZeneca in April and was replaced by Sharon Barr . → Vir Biotechnology ’s revamp took the spotlight in early August, as CEO Marianne De Backer made the decision to prop up its hepatitis B and D development and wind down its Covid-19, flu and T cell-based viral vector programs. On Wednesday, Vir said that Jason O’Byrne will succeed Sung Lee as CFO on Oct. 2. O’Byrne had the same title at Caribou Biosciences since February 2021 and is the former SVP of finance at Audentes Therapeutics . He spent 13 years with Genentech in a number of roles, including head of commercial finance for the Asia-Pacific region. To accommodate the makeover, Vir laid off about a quarter of its staff. → BridgeBio Oncology Therapeutics has selected Yong Ben as chief medical and development officer. Readers may know Ben from BeiGene , where he was CMO, solid tumors from 2019-22, and he’s been a venture partner at Eight Roads for the past two years. Ben was the global clinical leader of immuno-oncology clinical development at AstraZeneca when Imfinzi received its first approval for advanced bladder cancer in May 2017, and a week later, he became CMO of BioAtla . BridgeBio’s oncology spinout debuted in May with a $200 million infusion from Cormorant Asset Management , Omega Funds , GV and others. → As Endpoints News reported on Monday, Eli Lilly ended a three-month search by promoting Lucas Montarce to CFO. He replaces current Alphabet finance chief Anat Ashkenazi , with an interim stint by controller Gordon Brooks sandwiched in between. Montarce’s career at Lilly began in 2001 and has held enough positions to scroll through ever since. He was elevated to president and general manager for the Spain, Portugal and Greece hub in February after nearly three years as group VP, corporate controller and chief financial officer for Lilly Research Laboratories . He takes over as CFO at a time when the Indianapolis pharma’s market cap has exceeded $800 billion. → Pfizer CSO Mikael Dolsten has nabbed a spot on the board of directors at Rocket Pharmaceuticals . Dolsten announced in July that he would leave Pfizer after 15 years, but he’s sticking around until the company finds a successor. In late June, questions about manufacturing resulted in a CRL for marnetegragene autotemcel ( marne-cel ), Rocket’s gene therapy to treat an ultra-rare disease called severe leukocyte adhesion deficiency-I. → Meg Alexander has been promoted to president and COO of Ovid Therapeutics , which is on the verge of starting a Phase 2 study of its Graviton -partnered ROCK2 inhibitor in cerebral cavernous malformations. This is Alexander’s third appearance in as many years after she was named chief strategy officer last year and corporate affairs chief in 2022. “Her extensive experience, operational expertise, and business acumen position her well to lead the next phase of the company’s evolution,” Ovid CEO Jeremy Levin said in a statement . → Sana Biotechnology finance chief Nate Hardy will resign “for personal reasons” on Oct. 4, according to an SEC filing . Hardy was on the finance team at Juno Therapeutics with CEO Steve Harr before he took the CFO job at Sana in 2018. The Seattle-based biotech just hired UCB ’s Dhaval Patel as its CSO. → After five years on the job, Forge Biologics CEO Tim Miller is stepping down , making way for commercial chief John Maslowski to take over Oct. 1. Maslowski initially joined Forge as chief commercial officer in June 2021. Before that, he was president and CEO of Castle Creek Biosciences and Fibrocell Science . → Matt Shaulis is headed to BeiGene as general manager of North America on Sept. 25, while Josh Neiman — the chief commercial officer for North America and Europe — has stepped down “to pursue a new entrepreneurial opportunity at a healthcare technology startup,” according to a release . For the last year and a half, Shaulis has been chief commercial officer and US president for Swedish drug developer Hansa Biopharma , and he took on the role of president, inflammation and immunology for the international developed markets at Pfizer from 2018-21. At the end of his seven-year tenure with the pharma giant, he was elevated to SVP for global commercial and medical go-to-market model transformation. → Jeff Hartness has been named chief commercial officer at I&I biotech Apogee Therapeutics , which hit the Nasdaq with Sagimet Biosciences on July 14, 2023. Hartness spent more than 15 years with Sanofi before jumping to Bausch Health in 2016 as VP, strategic account management. Last year, he was promoted to EVP and head of Bausch Health’s market access, commercial operations, policy and government affairs teams, while serving as general manager of the neurology portfolio and generics businesses. Chaired by ex- Prometheus Biosciences chief and current Mirador Therapeutics CEO Mark McKenna , Apogee is trying to distinguish itself in the atopic dermatitis space with its monoclonal antibody APG777 . → The team at non-opioid pain biotech Latigo Biotherapeutics is quickly taking shape under new CEO Nima Farzan , who succeeded Westlake Village BioPartners ’ Desmond Padhi in late July. After bringing in medical chief Neil Singla last month, Latigo has tapped William Blair analyst Tim Lugo as CFO. Lugo joined William Blair as a senior associate in 2005 and would eventually become a partner, leading the biotechnology equity research team. Latigo also added Westlake managing director Beth Seidenberg and Foresite Capital ’s Jim Tananbaum to the board of directors. → Now that Rytelo ( imetelstat ) is being sold in the US for lower-risk myelodysplastic syndromes with transfusion dependent anemia, Geron Corporation has recruited Jim Ziegler as chief commercial officer. Ziegler had been EVP, commercial for Iovance , which secured the long-awaited FDA approval of its TIL therapy Amtagvi for melanoma in February. He also spent a decade in two separate stints with Gilead , culminating in his role as VP of the cardiopulmonary and inflammation business unit. → Alan List is retiring as CMO of Precision BioSciences , and 12-year Merck vet Murray Abramson has jumped on board to lead clinical development. Abramson left Merck in 2011 to become VP of global clinical operations at Biogen, a position he held for nine years. From 2020-22, Abramson was SVP of clinical innovation for Tempus . Precision also said in a release that ex- Aligos Therapeutics EVP John Fry will be a strategic clinical advisor for its hepatitis B program. Following his resignation as president and CEO of Moffitt Cancer Center over his connections to China, List reemerged as Precision’s medical chief in 2021. → Rami Daoud has made his way to gene therapy developer Affinia Therapeutics as chief business and financial officer. Daoud comes off a yearlong stint as president of GeneScience Pharmaceuticals USA and was a corporate development exec with Amarin . Rick Modi ’s crew was an Endpoints 11 winner in 2021 and had IPO aspirations that ultimately faded in late 2022. → HC Bioscience has recruited Simon Tsang to replace Christine Foster as CBO. Tsang is an Amgen corporate development alum who was VP, business development for Tesaro from 2016-19. After GSK bought Tesaro for $5.1 billion, he landed at Pivotal bioVenture Partners as an operating partner. HC Bioscience is in a small-but-emerging group of biotechs working on tRNA-based drugs, along with Flagship ’s Alltrna and Tevard Biosciences . → Rivus Pharmaceuticals , which claimed a Phase 2a win last month with its drug for obesity-related heart failure with preserved ejection fraction, has appointed Tom O’Neil as CFO and ex- ProfoundBio COO/CFO Erin Lavelle to the board of directors. As finance chief, O’Neil helped lead Satsuma Therapeutics to its IPO in 2019 and its sale to Shin Nippon Biomedical Laboratories last year. Lavelle orchestrated ProfoundBio ’s $112 million Series B in February, and Genmab would agree to buy the ADC biotech less than two months later. She also picked up another board seat this week at Aviceda Therapeutics. → We have an impressive lineup of CMO appointments: First, Eli Lilly’s obesity and metabolic disease partner HAYA Therapeutics has named Jordan Shin as CMO. Shin had been SVP of clinical development and translational science (cardiology) for gene therapy player Lexeo Therapeutics , which went public last November with a $100 million IPO. Earlier, he worked for Renovacor as SVP of clinical development and translational science until it was sold to Rocket Pharmaceuticals . Up to $1 billion is on the line with HAYA and Lilly’s recent drug discovery pact . → Canadian psychedelic biotech Reunion Neuroscience has brought in Mark Pollack as medical chief. Pollack briefly worked for Sage as SVP for global medical affairs and was part of a leadership shakeup that also involved the departures of CSO Al Robichaud and development chief Jim Doherty . Reunion went private last summer with the help of MPM BioImpact , and a $103 million Series A followed in May from MPM, Novo Holdings and several other investors. → A week after Reunion’s Series A financing, San Diego upstart Aardvark Therapeutics raised $85 million in a Series C to bankroll late-stage trials for its Prader-Willi syndrome asset ARD-101 . And like Reunion, Aardvark has found a new medical chief. Manasi Sinha Jaiman was promoted to the same position at stem cell therapy maker ViaCyte before it was sold to Vertex in 2022 for $320 million , and she would stay at Vertex as a VP. In the same release, Aardvark included the appointment of regulatory affairs leader Tom Bicsak , who came on board in July. → Milan-based AAVantgarde Bio is picking up Jayashree Sahni as CMO. Sahni is taking over the reins from Naveed Shams , who had served in the role since 2022. Sahni joins the team from Novartis , where she was senior global program clinical lead. Earlier in her career, Sahni was with Roche , where she worked on the Phase 1 and 2 clinical trials for Vabysmo . → Elsewhere, RA Capital -backed Tyra Biosciences has recruited Doug Warner as CMO. Warner joins the California-based crew from eFFECTOR Therapeutics , where he served in the same role. Previously, Warner had an 18-year stint at Amgen, where he led development of drugs like Vectibix , Xgeva and Prolia . Warner’s appointment comes after Tyra picked up $200 million in PIPE financing in February to progress its oral FGFR3-selective inhibitor, TYRA-300 . → Longwood ’s Solu Therapeutics , which debuted in August 2023 with a $31 million seed round, has welcomed Sergio Santillana as CMO. Peer Review told you about Santillana’s resignation from the same position at Ikena Oncology in February, and he’s also the ex-CMO at Merrimack Pharmaceuticals and Ariad Pharmaceuticals . Earlier in his career, Santillana had a string of roles at Eli Lilly, GSK and Takeda . → Maud Brandely is retiring after eight years as CMO of French cancer biotech Transgene , and Sanofi Genzyme vet Emmanuelle Dochy has replaced her . Dochy just completed a seven-year run at Bayer , where she recently served as VP of global medical affairs for the tyrosine kinase inhibitor (TKI) oncology franchise and scientific partnerships head. Meanwhile, Transgene has also enlisted Roche oncology alum Maurizio Ceppi as CSO. → KalVista Pharmaceuticals has named Brian Piekos as CFO. Far from his first run as finance chief, Piekos served in the role at Elicio Therapeutics , Gemini Therapeutics and AMAG Pharmaceuticals . In May, KalVista announced that it was dropping its preclinical program in hereditary angioedema in favor of focusing on its HAE pill sebetralstat . At the time, KalVista said it would find a partner for its dropped program. → Beverley Carr has taken the CBO post at London-based Charm Therapeutics , a startup co-founded by the University of Washington’s David Baker that uses its 3D deep learning tech DragonFold to discover new drugs. Carr is a GSK business development vet who had been chief business and operating officer for Amphista Therapeutics and then stepped into the role of interim CEO when Nicki Thompson left. → In July, Cue Biopharma announced that it was prioritizing its autoimmune pipeline and slashing 25% of its staff. Now, J&J vet Lucinda Warren has joined the Boston team as CBO. Warren’s 10-year stint at J&J culminated in her role as VP of business development for neuroscience and Japan regionally. Earlier in her career, Warren was with Janssen Cilag Australia and Centocor / Janssen Biologics . → Verily , the healthcare company spun out of Google parent Alphabet , has rolled out the welcome mat for Michael Radwin as its new head of data science and AI. Radwin joins from the CDC, where he was a founding member of the Office of Public Health Data, Surveillance, and Technology. Radwin’s résumé also includes roles at Intuit and Yahoo . Earlier in June, Verily announced that it was jumping into the GLP-1 business with the launch of a new virtual program to help patients manage cardiometabolic diseases with care teams and medications. → Dutch biotech VarmX , which is developing a reversal agent for blood thinners, has promoted Martijn Negen to the role of COO. Negen joined VarmX last September as SVP of global commercial strategy & business development from AM-Pharma . He also has experience from Portola Pharmaceuticals , Teva Global Specialty Medicines and Genentech. → Opthea has announced a slew of changes to its leadership team. First, the company is losing commercial chief Judy Robertson , CFO Peter Lang and SVP, global clinical operations Bruno Gagnon , effective Sept. 9. Filling in for Lang and Robertson in the interim will be Danforth Advisors managing director Daniel Geffken and Genentech and Novartis vet Mike Campbell , respectively. Meanwhile, Jen Watts will succeed Gagnon. That’s not all: Opthea is also picking up Dayong Li as SVP, biometrics and Anthony Bonifazio as VP, market access. → UK respiratory disease biotech Enterprise Therapeutics has introduced Annabella Amatulli as head of regulatory affairs. The Janssen vet was the global regulatory sciences leader for Alfasigma , the Italian company that bought Ocaliva maker Intercept Pharmaceuticals . → Tonix Pharmaceuticals has brought aboard Thomas Englese as EVP of commercial operations. Englese was formerly chief commercial officer of Tris Pharmaceuticals and Aziyo Biologics . Before that, he had an 11-year run with Mallinckrodt , culminating in his role as SVP and general manager of North America hospital therapies. → A handful of VCs have been making some moves. First up: Abingworth has turned to SFJ Pharmaceuticals founder and executive chair Robert DeBenedetto to tackle the role of managing director, clinical co-development; Sofinnova Partners has added a new partner. Karl Naegler just completed a four-year run as managing partner with Wellington Partners Life Sciences in June; and finally, Frazier Healthcare Partners has named Willis Chandler as an executive-in-residence on the growth buyout team. Chandler left Cencora (formerly AmerisourceBergen ) in June after nearly three years as president of global pharma services and six years overall. → Co-founded by Jim Wilson , Passage Bio has elected Ultragenyx CBO Tom Kassberg to the board of directors. One of Wilson’s new companies, GEMMA Biotherapeutics , licensed a trio of gene therapy candidates from Passage Bio in early August. → Enoch Kariuki has joined the board of directors at Cyrus Mozayeni ’s ADC shop Pheon Therapeutics , which is chaired by ex- Blueprint Medicines chief Jeff Albers . Kariuki became president of Endeavor BioMedicines this year and ran Lengo Therapeutics until it was purchased by Blueprint in 2021. → Yoshiharu Mizui now has a seat on the board of directors at SEED Therapeutics , the biotech near Philadelphia that struck a “molecular glue” deal with Eisai last month. Mizui is the president of Eisai’s VC arm, Eisai Innovation , and he also juggles two other roles as head of collaboration & incubation in the DHBL (Deep Human Biology Learning) office and head of academic & industry alliance. → Creyon Bio has made room for DCVC Bio operating partner Serge Messerlian and Lux Capital principal Shaq Vayda on the board of directors. Messerlian has board seats at Auron Therapeutics and Plexium , and Vayda’s numerous board credits include Atavistik Bio and Enveda Biosciences .