[144] Alaska Air Group, Inc. SEC Filing

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.

Form 144 Filer Information	UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 144 NOTICE OF PROPOSED SALE OF SECURITIES PURSUANT TO RULE 144 UNDER THE SECURITIES ACT OF 1933
FORM 144

144: Filer Information

Filer CIK
Filer CCC
Is this a LIVE or TEST Filing?	LIVE TEST
Submission Contact Information
Name
Phone
E-Mail Address

144: Issuer Information

Name of Issuer

SEC File Number

Address of Issuer

Phone

Name of Person for Whose Account the Securities are To Be Sold

See the definition of "person" in paragraph (a) of Rule 144. Information is to be given not only as to the person for whose account the securities are to be sold but also as to all other persons included in that definition. In addition, information shall be given as to sales by all persons whose sales are required by paragraph (e) of Rule 144 to be aggregated with sales for the account of the person filing this notice.

Relationship to Issuer

144: Securities Information

Title of the Class of Securities To Be Sold	Name and Address of the Broker	Number of Shares or Other Units To Be Sold	Aggregate Market Value	Number of Shares or Other Units Outstanding	Approximate Date of Sale	Name the Securities Exchange
Common	Charles Schwab & Co., Inc. 3000 Schwab Way Westlake TX 76262	7600	404501.00	121392507	07/28/2025	NYSE

Furnish the following information with respect to the acquisition of the securities to be sold and with respect to the payment of all or any part of the purchase price or other consideration therefor:

144: Securities To Be Sold

Title of the Class	Date you Acquired	Nature of Acquisition Transaction	Name of Person from Whom Acquired	Is this a Gift?	Date Donor Acquired	Amount of Securities Acquired	Date of Payment	Nature of Payment *
Common	02/09/2024	Restricted Stock Lapse	ALASKA AIR GROUP, INC			203	02/09/2024	Equity Compensation
Common	02/13/2024	Performance Stock Lapse	ALASKA AIR GROUP, INC			6327	02/13/2024	Equity Compensation
Common	02/07/2025	Restricted Stock Lapse	ALASKA AIR GROUP, INC			1070	02/07/2025	Equity Compensation

* If the securities were purchased and full payment therefor was not made in cash at the time of purchase, explain in the table or in a note thereto the nature of the consideration given. If the consideration consisted of any note or other obligation, or if payment was made in installments describe the arrangement and state when the note or other obligation was discharged in full or the last installment paid.

Furnish the following information as to all securities of the issuer sold during the past 3 months by the person for whose account the securities are to be sold.

144: Securities Sold During The Past 3 Months

Name and Address of Seller	Title of Securities Sold	Date of Sale	Amount of Securities Sold	Gross Proceeds
ANDREW R HARRISON 19300 INTERNATIONAL BOULEVARD SEATTLE WA 98188	ALASKA AIR GROUP, INC.	05/19/2025	7500	401330.00

144: Remarks and Signature

Remarks

Date of Notice

ATTENTION:

The person for whose account the securities to which this notice relates are to be sold hereby represents by signing this notice that he does not know any material adverse information in regard to the current and prospective operations of the Issuer of the securities to be sold which has not been publicly disclosed. If such person has adopted a written trading plan or given trading instructions to satisfy Rule 10b5-1 under the Exchange Act, by signing the form and indicating the date that the plan was adopted or the instruction given, that person makes such representation as of the plan adoption or instruction date.

Signature

ATTENTION: Intentional misstatements or omission of facts constitute Federal Criminal Violations (See 18 U.S.C. 1001)

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.