[Form 4] KeyCorp Insider Trading Activity

Rhea-AI Filing Summary

Alvotech’s July 2025 Form 6-K details governance, commercial, regulatory and financing actions since its Q1 report.

• Governance: Six directors re-elected; veteran executive Linda Jónsdóttir appointed CFO; COO Faysal Kalmoua exits board and management.
• Commercial: Advanz Pharma partnership broadened to three new biosimilars (milestones up to €160 m) and separate AVT10 (Cimzia) deal; global Keytruda biosimilar co-development with Dr. Reddy’s.
• M&A: Acquired Swiss packager Ivers-Lee and Xbrane’s Swedish R&D team plus Cimzia candidate for c.SEK 275 m.
• Pipeline: CHMP positive opinion for AVT06 (Eylea); AVT23 (Xolair) study shows therapeutic equivalence.
• Manufacturing risk: FDA pre-approval inspection (26 Jun–4 Jul) issued Form 483 citing operational, documentation and quality control deficiencies; detailed response submitted 25 Jul.
• Financing: Oversubscribed SDR IPO (SEK 39 m) and institutional placement (SEK 750 m) add >3,000 new holders; term-loan amendment folds second tranche, trims margin to SOFR+6.0%, facility now $1.081 bn, cash $152 m.

New capital and partnerships enhance growth prospects, but regulatory remediation is critical for near-term BLA approvals.

Positive

• €160 m milestone expansion of Advanz Pharma partnership covering three new biosimilars
• Global Keytruda biosimilar collaboration with Dr. Reddy’s broadens high-value oncology pipeline
• CHMP positive opinion for AVT06 and successful AVT23 efficacy study de-risk European approvals
• SEK 789 m equity raises were oversubscribed, adding >3,000 shareholders and improving liquidity
• Term-loan amendment lowers interest by 50 bp and simplifies capital structure, reducing financing costs

Negative

• FDA Form 483 cites multiple manufacturing and documentation deficiencies that could delay four pending BLAs
• Executive turnover with COO departure may disrupt operational continuity during critical remediation phase

Insights

Pharmaceutical Equity Analyst

TL;DR – Strong deals and financing offset by FDA Form 483 risk; net impact neutral.

Commercial wins with Advanz (€160 m milestones) and Dr. Reddy’s expand the oncology & autoimmune pipeline while Ivers-Lee adds downstream capacity. SEK 789 m of fresh equity plus a 50 bp interest cut strengthen liquidity and reduce cash burn. However, the Form 483 covers multiple quality-system gaps tied to four BLAs; approval timing for AVT02/03/05/06 now depends on FDA classification, creating binary regulatory risk. Overall, strategic momentum is positive but valuation upside is capped until inspection issues are fully resolved.

Regulatory Risk Analyst

TL;DR – Form 483 elevates approval risk; remediation plan is submitted but outcome uncertain.

The inspection observations span manufacturing controls, documentation and lab practices—areas often requiring re-inspection. While management claims some issues are historical, FDA follow-up could delay launch-ready assets and trigger additional costs. Positive CHMP feedback on AVT06 underscores EU progress, yet U.S. revenue inflection depends on clearing the Form 483. Investors should monitor FDA’s classification letter (OAI, VAI or NAI) and potential impact on 2025–26 launch schedules.

SEC Form 4

FORM 4

UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP

Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934
or Section 30(h) of the Investment Company Act of 1940

OMB APPROVAL

OMB Number:			3235-0287
Estimated average burden
hours per response:			0.5

Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).

1. Name and Address of Reporting Person^*

Evans Trina M

(Last) (First) (Middle)

C/O KEYCORP

127 PUBLIC SQUARE

(Street)

CLEVELAND OH 44114

(City) (State) (Zip)

2. Issuer Name and Ticker or Trading Symbol
KEYCORP /NEW/ [ KEY ]

5. Relationship of Reporting Person(s) to Issuer
(Check all applicable)

	Director		10% Owner
X	Officer (give title below)		Other (specify below)
	Director, Corporate Center

3. Date of Earliest Transaction (Month/Day/Year)
07/24/2025

4. If Amendment, Date of Original Filed (Month/Day/Year)

6. Individual or Joint/Group Filing (Check Applicable Line)

X	Form filed by One Reporting Person
	Form filed by More than One Reporting Person

Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1. Title of Security (Instr. 3)	2. Transaction Date (Month/Day/Year)	2A. Deemed Execution Date, if any (Month/Day/Year)	3. Transaction Code (Instr. 8)		4. Securities Acquired (A) or Disposed Of (D) (Instr. 3, 4 and 5)			5. Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4)	6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4)	7. Nature of Indirect Beneficial Ownership (Instr. 4)
			Code	V	Amount	(A) or (D)	Price
Common Shares	07/24/2025		S		17,000	D	$18.67	82,719	D

Table II - Derivative Securities Acquired, Disposed of, or Beneficially Owned (e.g., puts, calls, warrants, options, convertible securities)
1. Title of Derivative Security (Instr. 3)	2. Conversion or Exercise Price of Derivative Security	3. Transaction Date (Month/Day/Year)	3A. Deemed Execution Date, if any (Month/Day/Year)	4. Transaction Code (Instr. 8)		5. Number of Derivative Securities Acquired (A) or Disposed of (D) (Instr. 3, 4 and 5)		6. Date Exercisable and Expiration Date (Month/Day/Year)		7. Title and Amount of Securities Underlying Derivative Security (Instr. 3 and 4)		8. Price of Derivative Security (Instr. 5)	9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4)	10. Ownership Form: Direct (D) or Indirect (I) (Instr. 4)	11. Nature of Indirect Beneficial Ownership (Instr. 4)
				Code	V	(A)	(D)	Date Exercisable	Expiration Date	Title	Amount or Number of Shares

Explanation of Responses:

Remarks:

	Adam J. Larkins POA for Trina M. Evans	07/28/2025
	** Signature of Reporting Person	Date
Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly.
* If the form is filed by more than one reporting person, see Instruction 4 (b)(v).
** Intentional misstatements or omissions of facts constitute Federal Criminal Violations See 18 U.S.C. 1001 and 15 U.S.C. 78ff(a).
Note: File three copies of this Form, one of which must be manually signed. If space is insufficient, see Instruction 6 for procedure.
Persons who respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB Number.

FAQ

What regulatory setback did Alvotech (ALVO) disclose in the July 2025 6-K?

The FDA issued a Form 483 after a 26 Jun–4 Jul pre-approval inspection of the Reykjavik plant, noting quality-system deficiencies.

How much capital did Alvotech raise through recent share offerings?

Alvotech raised SEK 39 m via an SDR IPO and SEK 750 m through a private placement in June 2025.

What are the financial terms of the amended term-loan facility?

Post-amendment, the entire $1.081 bn facility bears SOFR + 6.0% cash interest, 50 bp lower than before, maturing July 2029.

Which pipeline assets received positive European feedback?

AVT06 (biosimilar to Eylea) received a positive CHMP opinion, and AVT23 (Xolair) met its primary endpoint in a confirmatory study.

What is the potential value of the expanded Advanz Pharma partnership?

The agreement includes up to €160 m in development and commercial milestones plus revenue sharing.