Biogen (BIIB) closes $5.3B Apellis deal, adds EMPAVELI and SYFOVRE growth
Rhea-AI Filing Summary
Biogen Inc. completed its acquisition of Apellis Pharmaceuticals, which is now a wholly owned subsidiary. Biogen’s tender offer valued Apellis at $41.00 in cash per share plus one contingent value right (CVR) per share, with each CVR allowing up to an additional $4.00 in cash if specified sales milestones are met. Approximately 105,687,831 Apellis shares, or about 82.4% of outstanding shares, were tendered before closing. The total cash consideration for the offer and merger is about $5.3 billion, funded with cash and a new $2 billion unsecured term loan split into two $1 billion tranches. Apellis’ key products, EMPAVELI and SYFOVRE, generated $689 million in 2025 net product revenue, and Biogen expects the deal to be accretive to its non‑GAAP diluted EPS in 2027 and to support longer‑term earnings growth.
Positive
- Strategic revenue growth and pipeline expansion: The Apellis acquisition adds EMPAVELI and SYFOVRE, which generated $689 million in 2025 net product revenue, broadens Biogen’s portfolio into complement‑driven diseases, and is expected to be accretive to non‑GAAP diluted EPS in 2027 with a higher long‑term EPS CAGR.
- Flexible, investment‑grade style financing: Biogen secured a $2 billion unsecured term loan split into short‑ and medium‑term tranches, with relatively low margins over Term SOFR and a leverage covenant that accommodates further material acquisitions under defined limits.
Negative
- None.
Insights
Biogen closes a $5.3B Apellis acquisition, funded partly with $2B term debt.
Biogen has finalized its purchase of Apellis Pharmaceuticals for cash plus CVRs, valuing the transaction at about $5.3 billion excluding potential CVR payouts. The structure combines an upfront cash premium with up to $4.00 per share in contingent value tied to future SYFOVRE sales milestones.
To support the deal, Biogen entered a new unsecured term loan credit agreement for $2 billion, split into a $1 billion 364‑day tranche and a $1 billion two‑year tranche, with interest based on Term SOFR or a base rate plus modest margins. A leverage covenant caps the consolidated leverage ratio at 3.75 to 1.0, with a temporary step‑up to 4.25 to 1.0 available for qualifying acquisitions.
Apellis adds two commercial products, EMPAVELI and SYFOVRE, which generated $689 million in 2025 net product revenue and expand Biogen into nephrology. Biogen states the acquisition should be accretive to non‑GAAP diluted EPS in 2027 and materially increase non‑GAAP EPS CAGR through the end of the decade, though actual results will depend on execution, CVR milestone achievement, and integration of Apellis’ pipeline and commercial infrastructure.
8-K Event Classification
Key Figures
Key Terms
Contingent Value Right financial
Term SOFR financial
non-GAAP diluted EPS financial
Risk Evaluation and Mitigation Strategy (REMS) regulatory
Section 251(h) regulatory
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Item 1.01 Entry into a Material Definitive Agreement.
CVR Agreement
As previously disclosed, on March 31, 2026, Biogen Inc., a Delaware corporation (“Biogen”), entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Apellis Pharmaceuticals, Inc., a Delaware corporation (“Apellis”), and Aspen Purchaser Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Biogen (“Purchaser”).
Pursuant to the Merger Agreement and in connection with the irrevocable acceptance for payment by Purchaser of all outstanding shares of common stock, par value $0.0001 per share, of Apellis (the “Shares”) validly tendered and not validly withdrawn pursuant to the Offer (as defined below), on May 14, 2026, Biogen, Apellis and Equiniti Trust Company, LLC, a New York limited liability trust company, entered into a Contingent Value Rights Agreement (the “CVR Agreement”) governing the terms of the CVRs (as defined below) issued pursuant to the Offer and the Merger (as defined below).
Each CVR represents a non-transferable contractual contingent right to receive the following cash payments, without interest and subject to reduction for any applicable tax withholding (the “Milestone Payments”) if the following milestones (each, a “Milestone”) are achieved:
| • | $2.00 per CVR, upon the achievement of Annual Net Sales (as defined in the CVR Agreement) of at least $1,500,000,000 attributable to SYFOVRE® and related products in the aggregate during the 2027, 2028, 2029 or 2030 calendar years (the “Net Sales Milestone 1”); and |
| • | $2.00 per CVR, upon the achievement of Annual Net Sales (as defined in the CVR Agreement) of at least $2,000,000,000 attributable to SYFOVRE® and related products in the aggregate during the 2027, 2028, 2029, 2030 or 2031 calendar years (the “Net Sales Milestone 2”), provided that if the Net Sales Milestone 1 is not met prior to December 31, 2030 but the Net Sales Milestone 2 is achieved during the 2031 calendar year, then the Net Sales Milestone 2 will be worth $4.00 per CVR. |
Each Milestone may only be achieved and paid once; if the Annual Net Sales threshold is met in multiple calendar years, only the first achievement triggers payment.
There can be no assurance that any Milestone will be achieved prior to the expiration or termination of the CVR Agreement, or that payment will be required of Biogen with respect to any Milestone.
The foregoing description of the CVR Agreement does not purport to be complete and is qualified in all respects by reference to the full text of the CVR Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Term Loan Credit Agreement
On May 12, 2026, Biogen entered into a Credit Agreement with U.S. Bank National Association (“U.S. Bank”), as administrative agent, and the lenders party thereto (the “Credit Agreement”). The Credit Agreement provides for unsecured term loan facilities in an aggregate principal amount of $2 billion (the “Term Facilities”), comprised of a $1 billion 364-day tranche (“Tranche A”) and a $1 billion two-year tranche (“Tranche B”). On May 13, 2026, in connection with the completion of the Offer and the Merger, Biogen borrowed the full amount available under the Credit Agreement.
The proceeds from the borrowings under the Term Facilities were used to pay a portion of the consideration for the Offer and the Merger and for other purposes in connection with the Transactions (as defined in the Credit Agreement).
Loans under the Credit Agreement are denominated in dollars. Tranche A loans bear interest at a rate per annum equal to either, at Biogen’s option, (a) Term SOFR (as defined in the Credit Agreement), subject to a floor of 0.000% per annum, plus an applicable margin of 0.750% or (b) Base Rate (as defined in the Credit Agreement), plus an applicable margin of 0.000%. Tranche B loans bear interest at a rate per annum equal to either, at Biogen’s option, (a) Term SOFR, subject to a floor of 0.00% per annum, plus an applicable margin ranging from 0.750% to 1.000% based on the ratings of Biogen’s non-credit enhanced, senior unsecured long-term debt, as determined by S&P Global Ratings and Moody’s or (b) Base Rate plus an applicable margin of 0.000%.
All amounts outstanding under the Term Facility shall become due and payable (a) in the case of Tranche A, May 12, 2027 and (b) in the case of Tranche B, May 12, 2028. Under the Term Facility, voluntary prepayments are permitted, in whole or in part, in minimum amounts without premium or penalty, other than customary breakage costs.
The Credit Agreement contains customary representations and warranties, affirmative and negative covenants and events of default that are, in each case, substantially similar to the equivalent terms of that certain Credit Agreement dated as of August 12, 2024 (as amended, restated, amended and restated, supplemented and/or otherwise modified prior to the date hereof), among Biogen, the lenders party thereto and Bank of America, N.A., as administrative agent.
The Credit Agreement also includes a financial covenant requiring Biogen to maintain, as of the end of each fiscal quarter, a maximum consolidated leverage ratio of 3.75 to 1.0 (which shall be temporarily increased, at the option of Biogen, to 4.25 to 1.0 upon notice by Biogen to U.S. Bank as a result of other material acquisitions from time to time, subject to customary limitations).
A copy of the Credit Agreement is attached hereto as Exhibit 10.2 and is incorporated herein by reference. The foregoing description of the Credit Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Credit Agreement.
Item 2.01 Completion of Acquisition or Disposition of Assets.
Pursuant to the Merger Agreement, on April 14, 2026, Purchaser commenced a tender offer (the “Offer”) to acquire any and all of the issued and outstanding Shares, in exchange for (i) $41.00 per Share, net to the seller in cash, without interest and subject to reduction for any applicable tax withholding (the “Cash Amount”), plus (ii) one contractual, non-transferable contingent value right per Share (each, a “CVR”) representing the right to receive contingent cash payments of up to an aggregate of $4.00 in cash, without interest and subject to reduction for any applicable tax withholding, upon the achievement of certain specified milestones (the Cash Amount plus one CVR, collectively, the “Offer Price”), upon the terms and subject to the conditions set forth in the Offer to Purchase, dated April 14, 2026 (as amended or supplemented from time to time, the “Offer to Purchase”) and in the related Letter of Transmittal.
On May 14, 2026, Biogen announced that the Offer and related withdrawal rights expired as scheduled at one minute after 11:59 p.m., Eastern Time, on May 13, 2026 (the “Expiration Time”) and that immediately prior to the Expiration Time, based on the information provided by the depositary for the Offer, a total of 105,687,831 Shares were validly tendered (and not validly withdrawn) pursuant to the Offer, representing approximately 82.4% of the Shares outstanding immediately prior to the Expiration Time. The number of Shares validly tendered (and not validly withdrawn) pursuant to the Offer (excluding Shares tendered pursuant to guaranteed delivery procedures that have not yet been “received”, as such term is defined by Section 251(h)(6)(f) of the General Corporation Law of the State of Delaware (the “DGCL”)), together with any Shares beneficially owned by Biogen or any of its subsidiaries, satisfied the Minimum Condition (as defined in the Offer to Purchase), and all other conditions to the consummation of the Offer having been satisfied or waived, on May 14, 2026, Purchaser irrevocably accepted for payment all Shares that were validly tendered (and not validly withdrawn) pursuant to the Offer, and payment for such Shares will be made promptly in accordance with the terms of the Offer and the Merger Agreement.
Following the completion of the Offer, the remaining conditions to the Merger (as defined below) set forth in the Merger Agreement were satisfied or waived, and on May 14, 2026, pursuant to the terms of the Merger Agreement, Purchaser merged with and into Apellis, without a vote of the stockholders of Apellis in accordance with Section 251(h) of the DGCL, with Apellis continuing as the surviving corporation of the Merger (the “Surviving Corporation”) and as a wholly owned subsidiary of Biogen (the “Merger”, and the date and time at which the Merger became effective is referred to as the “Effective Time”). Pursuant to the Merger Agreement, at the Effective Time, each Share (other than Shares that were (i) held in the treasury of Apellis, (ii) irrevocably accepted for purchase in the Offer by Purchaser and “received” (as such term is defined by Section 251(h)(6)(f) of the DGCL) by Purchaser, (iii) held by Biogen, Purchaser or any other wholly owned subsidiary of Biogen as of both the commencement of the Offer and immediately prior to the Effective Time and (iv) held by stockholders who were entitled to, and properly demanded, appraisal for such Shares in accordance with Section 262 of the DGCL) was cancelled and converted into the right to receive the Offer Price without interest, subject to reduction for any applicable withholding taxes (the “Merger Consideration”).
Pursuant to the terms of the Merger Agreement, effective as of immediately prior to the Effective Time, any outstanding and unexercised warrant to purchase Shares (each, an “Apellis Warrant”) was deemed to be exercised in full in a “cashless exercise” pursuant to its terms, and any Shares issued upon such deemed cashless exercise were automatically converted into the right to receive the Merger Consideration, without interest and subject to applicable withholding taxes. Apellis has confirmed that, as of immediately prior to the Effective Time, no Apellis Warrants were outstanding.
At the Effective Time, subject to all required withholding taxes and with each CVR payable in accordance with the CVR Agreement, each outstanding Apellis equity award was treated as follows: (i) each option to purchase Shares (each, an “Apellis Option”) that had vested as of immediately prior to the Expiration Time (including any Apellis Option that vested as a result of the transactions) with an exercise price less than the Cash Amount was automatically cancelled and converted into the right to receive from the Surviving Corporation a cash payment equal to the product of the total number of Shares underlying such vested Apellis Option multiplied by the excess of the Cash Amount over the exercise price per Share of such vested Apellis Option, plus one CVR per Share underlying such vested Apellis Option; (ii) each vested Apellis Option with an exercise price equal to or greater than the Cash Amount but less than the Aggregate Amount (as defined in the Merger Agreement) was cancelled and converted into the right to receive one CVR per Share underlying such vested Apellis Option (with any Milestone Payment reduced by the excess, if any, of the applicable exercise price per Share over the Cash Amount, as set forth in the CVR Agreement); (iii) each Apellis Option with an exercise price equal to or greater than the Aggregate Amount was cancelled for no consideration; (iv) each unvested Apellis Option was cancelled and converted into a contingent right to receive the same consideration as a comparably priced vested Apellis Option (including the right to receive one CVR per Share underlying such unvested Apellis Option, subject to the terms of the CVR Agreement), payable in cash, subject to the holder’s continued service through the applicable vesting dates and otherwise subject to the same terms and conditions (including any double-trigger vesting provisions, as extended under the terms of the Merger Agreement) as the original award; (v) each award of restricted stock units with respect to Shares (each, an “Apellis RSU”), including awards subject to both a time-based and performance-based vesting schedule (each, an “Apellis PSU”), that had vested as of immediately prior to the Expiration Time was automatically cancelled and converted into the right to receive a cash payment equal to the product of the total number of Shares underlying such vested Apellis RSU or vested Apellis PSU multiplied by the Cash Amount, plus one CVR per Share underlying such vested Apellis RSU or vested Apellis PSU; and (vi) each unvested Apellis RSU and unvested Apellis PSU was cancelled and converted into the contingent right to receive the same consideration as a vested award of the same type (including the right to receive one CVR per Share underlying such unvested Apellis RSU and unvested Apellis PSU, subject to the terms of the CVR Agreement), subject to the holder’s continued service through the applicable vesting dates (in the case of Apellis PSUs, through the end of the applicable performance period) and otherwise subject to the same terms and conditions (including any double-trigger vesting provisions, as extended under the terms of the Merger Agreement, but, in the case of Apellis PSUs, no longer subject to performance-based vesting conditions) as the original award. The number of Shares underlying each Apellis PSU was determined based on (A) actual performance as determined by the Compensation Committee of the Apellis Board as of the latest practicable date prior to the Effective Time with respect to total stockholder return-based Apellis PSUs granted in January 2026 and (B) the target performance levels for all other Apellis PSUs.
The aggregate amount to be paid by Purchaser in the Offer and the Merger is approximately $5.3 billion, excluding related fees and expenses and, for the avoidance of doubt, any amounts that may become payable pursuant to the CVRs. Biogen and Purchaser will fund the acquisition of the Shares in the Offer and the Merger through a combination of cash and borrowings. Biogen estimates it would need approximately $582 million to pay the maximum aggregate amount that the holders of CVRs (including holders of certain Apellis Options, Apellis RSUs, Apellis PSUs and Apellis Warrants who received CVRs pursuant to the Merger Agreement) would be entitled to if all of the Milestones are achieved.
The foregoing description of the Merger Agreement and the related transactions does not purport to be complete and is qualified in its entirety by reference to the full text of the Merger Agreement, a copy of which was filed as Exhibit 2.1 to the Current Report on Form 8-K filed by Biogen on March 31, 2026 and is incorporated herein by reference.
Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement.
The information set forth in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 2.03.
Item 7.01 Regulation FD Disclosure.
On May 14, 2026, Biogen issued a press release announcing, among other things, the consummation of the Merger. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information contained in this Item 7.01 and in Exhibit 99.1 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(a) Financial statements of businesses acquired.
The audited consolidated financial statements of Apellis for the fiscal year ended December 31, 2025 are incorporated herein by reference to Apellis’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission (the “SEC”) on February 24, 2026.
The unaudited condensed consolidated financial statements of Apellis for the quarterly period ended March 31, 2026 are incorporated herein by reference to Apellis’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2026, filed with the SEC on May 7, 2026.
(b) Pro forma financial information.
The unaudited pro forma financial information required by this Item 9.01(b) will be filed by amendment to this Current Report on Form 8-K no later than 71 calendar days after the date on which this Current Report on Form 8-K is required to be filed.
(d) Exhibits.
| Exhibit No. |
Description | |
| 2.1 | Agreement and Plan of Merger, dated as of March 31, 2026, by and among Apellis Pharmaceuticals, Inc., Biogen Inc. and Aspen Purchaser Sub, Inc. (incorporated herein by reference to Exhibit 2.1 of the Current Report on Form 8-K filed by Biogen with the SEC on March 31, 2026).† | |
| 10.1 | Contingent Value Rights Agreement, dated as of May 14, 2026, by and among Biogen, Apellis and Equiniti Trust Company, LLC. | |
| 10.2 | Credit Agreement, dated as of May 12, 2026, by and among Biogen, U.S. Bank National Association and the lenders party thereto. | |
| 99.1 | Press Release issued by Biogen, dated May 14, 2026. | |
| 99.2 | Audited consolidated financial statements of Apellis for the fiscal year ended December 31, 2025 (incorporated herein by reference to Apellis’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 24, 2026). | |
| 99.3 | Unaudited condensed consolidated financial statements of Apellis for the quarterly period ended March 31, 2026 (incorporated herein by reference to Apellis’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2026, filed with the SEC on May 7, 2026). | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL). | |
| † | Certain exhibits and schedules have been omitted pursuant to Item 601(b)(2) of Regulation S-K. Biogen hereby undertakes to furnish supplemental copies of any of the omitted exhibits and schedules upon request by the SEC. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Biogen Inc. | |||||
| Date: May 14, 2026 |
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By: | /s/ Wendell Taylor | |||
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Name: Wendell Taylor | ||||
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Title: Secretary | ||||
Exhibit 99.1
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Biogen Completes Acquisition of Apellis Pharmaceuticals
Cambridge, Mass. – May 14, 2026 – Biogen Inc. (Nasdaq: BIIB) today announced the successful completion of the acquisition of Apellis Pharmaceuticals, Inc. (Nasdaq: APLS). Apellis, a leader in advancing treatments for serious, complement-driven diseases, is now a wholly owned subsidiary of Biogen.
The acquisition adds two best-in-class commercialized products, EMPAVELI® and SYFOVRE®, significantly bolstering Biogen’s near-term growth outlook and accelerating the Company’s expansion into nephrology. Together, the products recorded $689 million in net product revenue in 2025. This transaction will strengthen Biogen’s revenue and EPS growth potential by being accretive to Biogen’s Non-GAAP diluted EPS in 2027 and is expected to materially increase Biogen’s non-GAAP EPS compound annual growth rate (CAGR) through the end of the decade. Updated financial guidance will be provided in conjunction with the Q2 earnings report in July.
Apellis also brings an established nephrology commercial and medical infrastructure to accelerate Biogen’s launch readiness for felzartamab, with a first Phase 3 readout in antibody-mediated rejection in kidney transplant patients anticipated in the first half of 2027.
Biogen’s tender offer, to acquire all of the outstanding shares of Apellis common stock for $41 per share in cash and one contractual, non-transferable contingent value right per share representing the right to receive contingent cash payments of up to an aggregate of $4 in cash upon the achievement of certain annual global net sales thresholds for SYFOVRE®, expired one minute after 11:59 p.m., Eastern Time, on May 13, 2026. Equiniti Trust Company, LLC, the depositary for the tender offer, has advised Biogen that approximately 105,687,831 shares were validly tendered and not validly withdrawn in the tender offer, representing approximately 82.4% of the total outstanding shares as of the expiration time. All conditions to the tender offer having been satisfied or waived on May 14, 2026, Aspen Purchaser Sub, Inc. (Aspen), a wholly owned subsidiary of Biogen, accepted for payment all shares that were validly tendered and not validly withdrawn pursuant to the tender offer.
Following the consummation of the tender offer, Aspen merged with and into Apellis in accordance with Section 251(h) of the General Corporation Law of the State of Delaware without a vote of Apellis shareholders, with Apellis continuing as the surviving corporation of the merger and a wholly owned subsidiary of Biogen. In connection with the merger, the shares that were not tendered in the tender offer were acquired by Biogen and converted into the right to receive the offer price. In connection with the completion of the transaction, the Apellis shares ceased trading on Nasdaq.
About SYFOVRE® (pegcetacoplan injection)
SYFOVRE® (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (GA) secondary to AMD. By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States and Australia for the treatment of GA secondary to age-related macular degeneration.
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About Geographic Atrophy
Geographic atrophy is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, impacting more than one million Americans and five million people worldwide.1,2 It is a progressive and irreversible disease caused by the growth of lesions, which destroys the retinal cells responsible for vision. Vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. While rates of progression vary between patients, on average, it takes 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.3
About EMPAVELI®/Aspaveli® (pegcetacoplan)
EMPAVELI® (Aspaveli® in the EU) (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. It is the first treatment approved in the United States for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age or older, to reduce proteinuria. EMPAVELI®/Aspaveli® is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally, and for the treatment of C3G and primary IC-MPGN in the European Union and other countries globally. EMPAVELI is being evaluated for the treatment of additional rare diseases. Sobi has commercial rights to EMPAVELI®/Aspaveli® outside the U.S.
About C3 Glomerulopathy (C3G) and Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring lifelong dialysis therapy or a burdensome kidney transplant.4-6 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.7
About Paroxysmal Nocturnal Hemoglobinuria (PNH)
Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired, rare, chronic, and potentially life-threatening blood disease that is associated with persistently low (below normal) hemoglobin levels, thrombosis, and debilitating symptoms. PNH can appear at any age and in any race or gender, and is most often diagnosed in people in their early 30s.8,9
U.S. Important Safety Information for SYFOVRE® (pegcetacoplan injection)
CONTRAINDICATIONS
| • | SYFOVRE® is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred. |
WARNINGS AND PRECAUTIONS
| • | Endophthalmitis and Retinal Detachments |
| • | Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. |
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| • | Retinal Vasculitis and/or Retinal Vascular Occlusion |
| • | Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay. |
| • | Neovascular Age-related Macular Degeneration (AMD) |
| • | In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. |
| • | Intraocular Inflammation |
| • | In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE. |
| • | Increased Intraocular Pressure |
| • | Acute increase in intraocular pressure may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed. |
ADVERSE REACTIONS
| • | Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage. |
Please see full Prescribing Information for more information.
U.S. Important Safety Information for EMPAVELI® (pegcetacoplan)
BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA
EMPAVELI®, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
| • | Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor. |
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| • | Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected. |
Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS.
CONTRAINDICATIONS
| • | Hypersensitivity to pegcetacoplan or to any of the excipients |
| • | For initiation in patients with unresolved serious infection caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B |
WARNINGS AND PRECAUTIONS
Serious Infections Caused by Encapsulated Bacteria
EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria.
Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.
Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections.
EMPAVELI is available only through a restricted program under a REMS.
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EMPAVELI REMS
EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following:
Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients’ vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified.
Further information is available at www.empavelirems.com or 1-888-343-7073.
Infusion-Related Reactions
Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved.
Monitoring Paroxysmal Nocturnal Hemoglobinuria (PNH) Manifestations after Discontinuation of EMPAVELI
After discontinuing treatment with EMPAVELI, closely monitor for signs and symptoms of hemolysis, identified by elevated Lactate Dehydrogenase (LDH) levels along with sudden decrease in PNH clone size or hemoglobin, or reappearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinues EMPAVELI for at least 8 weeks to detect hemolysis and other reactions. If hemolysis, including elevated LDH, occurs after discontinuation of EMPAVELI, consider restarting treatment with EMPAVELI.
Interference with Laboratory Tests
There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels.
ADVERSE REACTIONS
Most common adverse reactions in adult patients with PNH (incidence ≥10%) were injection site reactions, infections, diarrhea, abdominal pain, respiratory tract infection, pain in extremity, hypokalemia, fatigue, viral infection, cough, arthralgia, dizziness, headache, and rash.
Most common adverse reactions in adult and pediatric patients 12 years of age and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) (incidence ≥10%) were injection-site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea.
USE IN SPECIFIC POPULATIONS
Females of Reproductive Potential
EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose.
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Please see full Prescribing Information, including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and Medication Guide.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Facebook, Instagram, LinkedIn, X, YouTube.
Biogen Forward Looking Statements
This press release contains forward-looking statements that are being made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995 (the PSLRA) with the intention of obtaining the benefits of the “Safe Harbor” provisions of the PSLRA. This press release contains forward-looking statements, relating to: the anticipated benefits of the Apellis Pharmaceuticals, Inc. acquisition (the “Acquisition”), our strategy and our future financial and operating results, including with respect to launch readiness for felzartamab, costs and other anticipated financial impacts of the Acquisition, including Biogen revenue, non-GAAP EPS and non-GAAP EPS growth, and the expected revenue growth for EMPAVELI® and SYFOVRE® following the Acquisition. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements.
Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part.
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pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.
These statements speak only as of the date of this presentation and the discussions during this conference call and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated, or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
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| 7. | Tarragón, B, et al. C3 Glomerulopathy Recurs Early after Kidney Transplantation in Serial Biopsies Performed within the First 2 Years after Transplantation. Clinical Journal of the American Society of Nephrology. August 2024; 19(8)1005-1015. |
| 8. | Paroxysmal nocturnal hemoglobinuria (PNH). The Sidney Kimmel Comprehensive Cancer Center Web site. https://www.hopkinsmedicine.org/kimmel_cancer_center/types_cancer/paroxysmal_nocturnal_hemoglobinuria_PNH.html. Accessed November 20, 2019. |
| 9. | Besa EC. Paroxysmal nocturnal hemoglobinuria (PNH). MedScape 2017; https://emedicine.medscape.com/article/207468-overview. Accessed November 20, 2019. |
| MEDIA CONTACT:
Biogen
Madeleine Shin + 1 781 464 3260 public.affairs@biogen.com |
INVESTOR CONTACT:
Biogen
Tim Power +1 781 464 2442 IR@biogen.com |
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