宏观因素对生物技术行业的影响-总体温和，但需关注FDA工作负担过重问题

Macro impact to Biotech - modestoverall, but watch for FDA workoverload U.S. Small & Mid Cap BiotechnologyPOSITIVE We conducted macro analysis and see minimal impact of theBig Beautiful Bill, minimal/moderate impact oftariffs/IP,modest impact of MFN pricing, FDA leadership change amajor impact on COVID vaccines, no impact on rare diseasespace (remains flexible), major focus on emerging FDA workoverload. U.S. Small & Mid Cap Biotechnology Gena Wang, PhD, CFA+1 212 526 4252gena.wang@barclays.comBCI, US Tony Deng, MD+1 212 526 0350tony.deng@barclays.comBCI, US Extel matters to me and Barclays. The Wang team has worked tirelessly to providedifferentiated,high-quality research. We appreciate your5-star supportin the2025 Extel All-America ResearchSurveyin theSMid Cap Biotech category.View our analysts » Vote 5 Stars for Barclays » Justin Kong, MD+1 212 526 1961justin.kong@barclays.comBCI, US Hang Hu, PhD+1 212 526 6364hang.hu@barclays.comBCI, US Key takeaways. Our analysis of recent macro updates covered 4 topics: the Big Beautiful Bill,MFN pricing,tariff/IPand HHS/FDA leadership. We see an overall minimal to moderate impactwhen excluding the COVID vaccine space. We would pay close attention to the emerging issuewith FDA's heavy workload and its impact on drug review and approval timelines. Big BeautifulBill: Based on Medicaid exposure, we estimate the impact on 2034E WW revenues of ~0-3.7%(worst for SRPT/PTCT, least for ALNY/LEGN). MFN pricing: Based on EU vs. US pricing, weestimate the impact on WW revenues of ~0-45% (worst for BCRX/VRTX, least for ALNY/LEGN).Tariffsand IP: Based ontariffrates and ex-US exposure, we estimate the impact on grossmargin of ~0-4% (worst for BMRN/VRTX, least for BCRX/LEGN). FDA/HHS leadershipchanges: Recent commentary, personnel changes, and regulatory updates were mixed (worstfor MRNA, positive for rare diseases). FDA workload constraints could have a broad negativeread-through to biopharma. We continue to see ALNY, CYTK and LEGN as our favorite picks for2025 given minimal impact from macro, along with robust revenue growth potential in 2025 andbeyond. Big Beautiful Bill. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Medicaid enrollment reduction possibly ~7.5% - minimal/moderate impact to our coverage. . . 3Most impact on PTCT/SRPT and least on ALNY/LEGN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Most-Favored Nation Pricing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Negative impact to our coverage, although strategies available to address the issue . . . . . . . . . . 7Most impact on BCRX/VRTX and least on ALNY/LEGN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Tariffsand IP Domicile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Mild to moderate impact to our coverage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Most impact on BMRN/IONS and least on BCRX/LEGN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10HHS and FDA Updates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Vaccine policy subject to uncertainties, with negative impact to MRNA. . . . . . . . . . . . . . . . . . . . . . 13FDA seemingly more flexible in rare diseases, positive across our coverage. . . . . . . . . . . . . . . . . . 17Emerging issue of FDA heavy workload raises attention to drug approval timelines. . . . . . . . . . . 17 Big Beautiful Bill Medicaid enrollment reduction possibly ~7.5% - minimal/moderateimpact to our coverage •One Big Beautiful Bill Act passed by house to senate, with goal for enactment of July 4,•2025.On May 22, the House passed (215-214) a budget reconciliation bill ("One Big BeautifulBill Act"). In June, the bill would begin review by the senate for consideration and possiblechanges. A goal for enactment was set for July 4. The CBO (Congressional BudgetOffice)estimated budget reductions could be ~$698B (LINK) from 2026-2034, and CBOpreviously estimated total budget from 2026-2034 of ~$6,862B (LINK). We note the bill has notpassed, and could be rejected/modified by the senate before potential enactment. •Medicaid policy changes could reduceaffordabilityand access.Budget reductions would•result from policy changeseffectiveatdifferenttimes (LINK). Cost-sharing cap was at $35 (“inno case may a deduction, cost sharing, or similar charge imposed under the State plan withrespect to an item or service furnished to a specified individual exceed $35"). Retroactivecoverage period was reduced from ~3 to ~1 mon (“striking the third month and inserting themonth"). Enactment of eligibility and enrollment final rules (“Streamlining Medicaid,Medicare saving program eligibility”) for low-income pts would be delayed until at least"January 1, 2035.” There would also be stricter eligi