Newsletter · 2026-05-01 · Ashutosh Agarwal

Eli Lilly Posts a Strong Q1 and the FDA Restricts GLP-1 Compounding - Healthcare Podcast Weekly Digest - Week of April 27 – May 1, 2026

Healthcare sector podcast and news synthesis for April 27 – May 1, 2026. Eli Lilly's blowout Q1 and the Foundayo oral GLP-1 launch, UnitedHealth's turnaround quarter, the FDA's 503B compounding crackdown, and a biopharma M&A market running its hottest in years.

Healthcare Podcast Weekly Digest

Week of April 27 – May 1, 2026: Eli Lilly Posts a Strong Q1 and the FDA Restricts GLP-1 Compounding

Opening Summary

It was a defining week for the healthcare sector, dominated by Eli Lilly's blowout Q1 print (revenue +56% to $19.8B, FY26 guidance raised to $82–85B) and the early read on Foundayo (orforglipron), the first oral GLP-1 pill approved in the US, with management disclosing >20,000 patients started and >80% new to GLP-1 therapy. UnitedHealth's reset-and-raise quarter (now on Goldman's Conviction List with a $435 PT) catalyzed a broad managed-care relief rally, while the FDA's April 30 proposal to exclude semaglutide/tirzepatide/liraglutide from the 503B bulks list effectively closes the door on legal mass-scale compounding. Underneath the headlines, biopharma M&A remains "the hottest in years" (4–5 deals already > $5B in 2026 vs. zero in all of 2024), with Lilly alone closing three $1B+ deals plus seven alliances in Q1.

Key People This Week

Hot Topics

Eli Lilly (LLY), The Print of the Quarter

• Q1 2026 revenue $19.8B vs. consensus $17.8B; non-GAAP EPS $8.55 vs. $6.79 consensus (52¢ IPR&D drag).
• FY26 revenue guide raised to $82–85B from $80–83B; FY26 EPS raised to $35.50–37.00 from $33.50–35.00. (thefly, Apr 30)
• Mounjaro Q1 ~$8.7B (+125% YoY); Zepbound +$4.2B; Lilly ~60% of US incretin market vs. Novo's ~39%. (heygotrade.com)
• Foundayo launch: >20,000 patients started; >80% new to GLP-1; ~35% via DTC. STAT's Allison DeAngelis: "really goes to show how much of the obesity market there is still to tap into." (The Readout Loud, Apr 30)
• 2025 ranking flip: Lilly became the #1 pharma globally (up from 10th); top-line +45%; Mounjaro and Zepbound contributed $20B of growth. (Citeline, Apr 21)
• Tuck-in M&A: Lilly to acquire Ajax (oral Type II JAK2 inhibitor for myelofibrosis) for up to $2.3B. (thefly, Apr 27)

UnitedHealth (UNH), Turnaround Confirmed

• Q1 stock +6% to $342.89; raised FY26 EPS guide to >$18.25; MCR improved to 84% from 85% prior; Optum Health margins reaffirmed at 6–8%. (thefly, Apr 21)
• AI commitment: $1.5B investment in FY26 AI initiatives. (thefly, Apr 21)
• Goldman added UNH to US Conviction List May 1, $435 PT, citing the company "is nearing the bottom of its underwriting cycle for Medicare Advantage" (40% of the business). (thefly, May 1)
• PT raises across the Street post-print: JPMorgan $420 (from $389), Piper Sandler $420, Oppenheimer $405, Argus upgrade to Buy/$400, Morgan Stanley $395, Wells Fargo $397, RBC $400. Lone holdout: Baird (Underperform, $287). (thefly, Apr 22–28)
• Standardizing electronic prior authorization across >50% of PA volume, climbing to >70% by year-end 2026. (thefly, Apr 24)

Compounding Cliff

• FDA proposes to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list (Apr 30): "no clinical need for outsourcing facilities to compound these drugs from bulk substances." (FDA via thefly, Apr 30)
• Earlier in the week: BPI halted GLP-1 production (Apr 23), following ProRx (Apr 8). 503As capped at 4 scripts/month per Apr 2 FDA enforcement memo. (On The Pen, Apr 23)
• Lilly–Hims distribution: Hims & Hers expanded LillyDirect access to Zepbound vials, KwikPen, and Foundayo; HIMS +7% pre-market on the news. BofA raised PT to $32. (thefly, Apr 23–24)

Medicare BALANCE Model, Effectively Stalled

• Apr 20 was the deadline for Medicare insurers to opt in. CVS opted out; Lilly/Novo dropped 3% / 2%. (thefly, Apr 21)
• UNH's Bobby Hunter cited "notable challenges and outstanding questions with the currently planned structure." (thefly, Apr 21)
• The original $245/month Medicare price + $50 copay structure now indefinitely delayed; Bridge program extended through end of 2027 at potentially "tens of billions" in federal cost (Elaine Chen, STAT). (The Readout Loud, Apr 23)

2025 Global Drug Sales Reshuffle (Citeline, Apr 21)

• Keytruda #1 at $31.6B (+7%), with 2028 patent expiry; Keytruda Culex (sub-Q) targeted for ~⅓ of Keytruda sales by 2030.
• Mounjaro #2 (sales doubled YoY).
• Ozempic #3 (still grew ~$2B; "may have been Ozempic's last year of growth").
• Dupixent #4; Zepbound #9 ($13.6B FY25); Pfizer slipped to #2 company globally on $1.2B revenue decline (sole top-12 decliner).

Key Debates (Bull vs. Bear)

Debate 1: GLP-1 Long-Term Equity Value

• Bull (Goldman / STAT): Foundayo's 80% new-to-GLP-1 mix proves massive untapped TAM; LLY raising into +56% growth quarter; pricing reductions reliably translate into volume. (Closing Bell, Apr 27)
• Bear (Shkreli): "Eventually GLPs…they're perfect…Ozempic going generic. Mounjaro eventually…going generic. So Lilly's kind of screwed." Consumers have "zero brand identity." (The a16z Show, Apr 23)

Debate 2: Foundayo vs. Oral Wegovy Launch Trajectory

• Bear read (STAT/Chen): Novo's oral Wegovy reportedly ~50K weekly scripts "a few weeks into launch" vs. Foundayo's >20K total starts so far, "Wegovi pill launch may have been going stronger." (The Readout Loud, Apr 30)
• Bull read (STAT/Feuerstein + Goldman): Tracker services "may be undercounting Foundayo." Goldman is "very comfortable" with the consensus number. (The Readout Loud, Apr 30)

Debate 3: Compounding Crackdown, Branded Tailwind or Patient-Access Risk?

• Bull (LLY/NVO): 503B shutdowns + FDA bulks-list exclusion accelerate brand recapture.
• Bear (Hemi): "If people literally can't get their prescriptions, it's more likely to be gray [market]…a lot of people on compounded medication genuinely can't afford the Lilly Direct numbers." (On The Pen, Apr 23)

Debate 4: UNH, Buy the Turnaround or Wait for Stars/2028 Notice?

• Bull (Goldman Conviction List, JPM, Piper, Argus): MA cycle bottoming; conservative guide; OptumHealth strength removes downside multiple case. (thefly, Apr 22–May 1)
• Bear (Baird, Underperform $287): OptumHealth fine but "Insight remains concerning"; BofA Neutral awaiting visibility on Stars and 2028 MA rate notice. (thefly, Apr 22)

Debate 5: In Vivo vs. Ex Vivo CAR-T

• Bull (Roberts/Venrock): Colonia ASH data (4/4 MM patients in MRD-negative CR) suggests "ex vivo is done" if results hold; targeting 70× return. (The Readout Loud, Apr 23)
• Counter: Ex vivo CAR-Ts (Carvykti tracking to $5–6B in 2029–30) still own commercial momentum; viral vs. LNP delivery represent distinct risk profiles.

Debate 6: FDA Real-Time Trial Data Review (AZ, AMGN pilot)

• Pro: Faster approvals, better safety signal-detection.
• Con (Chen/STAT): "Interim results don't always translate to the final outcomes…would we be advancing some programs too quickly?" (The Readout Loud, Apr 30)

Emerging Themes

1. The "Pivot to Pills" reframes the obesity TAM. With Foundayo's 80% new-to-GLP-1 mix and Hims/LillyDirect distribution, oral GLP-1s are positioned to expand the addressable population well beyond injectable adopters.
2. MFN pricing is starting to bite at the franchise level. Novo Nordisk guided to 5–13% sales decline in 2026, primarily attributed to its US MFN agreement. The White House completed MFN deals with all 17 named pharma companies (Regeneron last). (Citeline, Apr 21 / Telltales, Apr 29)
3. Pharma–AI infrastructure deals are now a recurring capex line. Lilly + NVIDIA $1B/5-yr SF Bay AI lab; Novartis CEO joined Anthropic's board; Novo–OpenAI integration; Novartis–Relation deal "potentially worth over $1.75B." (Citeline, Apr 27)
4. Mid-cap pharma as M&A acquirer cohort. Cooley's Bill Roegge: BioMarin, Neurocrine, Lundbeck, Jazz, BioNTech, Lantheus, Genmab "have done billion-plus deals recently." (Citeline, Apr 22)
5. China in-licensing has gone from anecdote to structural. Notable example: Kylera's ribupetide platform fully in-licensed from Hengrui. (Citeline, Apr 27)
6. LP(a) emerging as next major cardiovascular battleground. Goldman: "We don't even have placeholders in our models outside of Novartis for these drugs right now." Watch Amgen and Lilly CERNAS programs. (Closing Bell, Apr 27)
7. Generics manufacturers as patent-cliff beneficiaries. Telltales' Wallace: "the winner of [patent cliffs] is the generics manufacturers." Teva's pivot fits this thesis, with the third-largest biosimilar portfolio in the world. (Telltales, Apr 29 / CNBC Money Movers, Apr 29)
8. Iran blockade / freight disruption is the supply-chain wildcard. Freight rates "nearly doubled"; Asian solvent costs spiking; ASHP's Gagneau: no immediate impact yet, but contract drug manufacturers may invoke "force majeure clauses." (Citeline, Apr 27)

Deals & M&A Tracker

Industry M&A firepower ~$650B (Goldman/Haider, levered ~2.5× EBITDA). Lilly alone closed 3× $1B+ deals + 7 alliances in Q1 2026, "Lilly is doing these deals from a position of strength" (Roegge). (Closing Bell, Apr 27 / Citeline, Apr 22)

Biggest IPO of the year: Kylera Therapeutics grossed $625M on Apr 16 (potentially $718.8M with overallotments), closing +63% on day one, potentially the largest US drug-developer IPO ever. Ribupetide (GLP-1/GIP) Phase 3 obesity data expected 2028. (Citeline, Apr 27)

Regulatory Watch

• FDA proposes to exclude semaglutide, tirzepatide, liraglutide from the 503B bulks list (Apr 30), Commissioner Makary: "When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need." (thefly, Apr 30)
• FDA approves Axsome's Auvelity for Alzheimer's agitation (Apr 30), only the second drug approved for this indication. (neurologylive.com)
• Travere Therapeutics / Filspari approved (Apr 13), first FDA-approved drug for FSGS (~40K US patients); Travere holds monopoly. (Citeline, Apr 21)
• Revolution Medicines daraxonrasib Phase 3, pancreatic cancer OS 13.2 mo vs. 6.7 mo control; Evercore's Kazimov: "unequivocally practice-changing." Filing imminent; possible 2026 launch. (Citeline, Apr 21)
• Recent gene-therapy approvals: Rocket's Kresladi (LAD-I); Otarmeni (OTOF hearing loss).
• FDA real-time data review pilot, starting with AZ and Amgen oncology trials on Paradigm Health platform; broader pilot in summer 2026. (The Readout Loud, Apr 30)
• Medicare BALANCE Model effectively stalled after CVS and other insurers declined to opt in by the Apr 20 deadline. (thefly, Apr 21)
• Prior authorization reform, UnitedHealthcare scaling standardized e-PA to >70% of volume by year-end. (thefly, Apr 24)
• Most-Favored-Nation pricing, White House completed MFN contracts with all 17 named pharma companies; Regeneron last to sign. (Telltales, Apr 29)
• Lilly v. Mochi Health, federal judge denied Mochi's motion to dismiss; discovery proceeding. (On The Pen, Apr 23)

Week Ahead

• Wed, May 6, Novo Nordisk Q1 2026 earnings. Read-throughs: oral Wegovy script trajectory, US MFN impact on guide (already framed at -5 to -13%), defense vs. Foundayo. (heygotrade.com)
• Imminent FDA decisions: Grace Therapeutics' IV nimodipine (GTx-104) for aneurysmal SAH; rare-disease readouts including Regenxbio's RGX-121 for Hunter syndrome. (primetherapeutics.com)
• End of May, ASCO 2026. Watch: Colonia / Lilly in vivo CAR-T myeloma update; Merck next-gen oncology targets; Revolution Medicines daraxonrasib filing momentum.
• Friday morning Foundayo script tracking. Goldman: "Investors are going to be scrutinizing every Friday morning…what these script trends look like." (Closing Bell, Apr 27)
• Bristol-Myers, Merck, Cigna earnings already underway (BMY consensus $1.42; MRK ($1.47) loss; CI $7.60). (thefly, Apr 29)
• GSK B7H4 ADC (MORES) Phase 3 starts "in the next few months" (5 trials).
• Compounding transition window. With FDA bulks-list exclusion proposed Apr 30 and the BPI/ProRx 503B shutdowns, expect supply disruption signals over the next 30–60 days; Lilly Direct / gray-market monitoring required.

Sources

• The Readout Loud, Apr 23 & Apr 30
• Closing Bell, Apr 27
• CNBC Money Movers, Apr 29
• On The Pen, Apr 23
• The a16z Show, Apr 23
• Citeline, Apr 21, Apr 22 & Apr 27
• Telltales, Apr 29
• thefly, Apr 21–May 1

This digest is based on podcast, news, and web sources from April 21 – May 1, 2026. It is for informational purposes and does not constitute investment advice.