UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE TO
TENDER OFFER STATEMENT UNDER SECTION 14(d)(1) OR 13(e)(1)
OF THE SECURITIES EXCHANGE ACT OF 1934
CTI BIOPHARMA CORP.
(Name of Subject Company (Issuer))
CLEOPATRA ACQUISITION CORP.
(Name of Filing PersonOfferor)
An Indirect Wholly Owned Subsidiary of
SWEDISH ORPHAN BIOVITRUM AB (PUBL)
(Name of Filing PersonParent of Offeror)
Common Stock, par value $0.001 per share
(Title of Class of Securities)
12648L601
(CUSIP Number of Class of Securities)
Torbjörn Hallberg
Swedish Orphan Biovitrum AB (publ)
General Counsel and Head of Legal Affairs
Tomtebodavägen 23A
SE-112 76
Stockholm, Sweden
+46 8 697 20 00
(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Persons)
Copy to:
R. Scott Shean, Esq.
Leah R. Sauter, Esq.
Latham & Watkins LLP
650 Town Center Drive
20th Floor
Costa Mesa, CA
(714) 540-1235
☒ | Check the box if the filing relates solely to preliminary communications made before the commencement of a tender offer. |
Check the appropriate boxes below to designate any transactions to which the statement relates:
☒ | Third-party offer subject to Rule 14d-1. |
☐ | Issuer tender offer subject to Rule 13e-4. |
☐ | Going-private transaction subject to Rule 13e-3. |
☐ | Amendment to Schedule 13D under Rule 13d-2. |
Check the following box if the filing is a final amendment reporting the results of the tender offer: ☐
If applicable, check the appropriate box(es) below to designate the appropriate rule provision(s) relied upon:
☐ | Rule 13e-4(i) (Cross-Border Issuer Tender Offer) |
☐ | Rule 14d-1(d) (Cross-Border Third Party Tender Offer) |
This filing relates solely to preliminary communications made before the commencement of a planned tender offer by Cleopatra Acquisition Corp., a Delaware corporation (Purchaser), an indirect wholly-owned subsidiary of Swedish Orphan Biovitrum AB (publ), a Swedish public limited liability company (Parent), for all of the outstanding common stock, par value $0.001 per share (the Shares), of CTI BioPharma Corp., a Delaware corporation (the Company), for $9.10 per Share, net to the seller in cash, without interest and subject to any applicable withholding taxes, pursuant to the Agreement and Plan of Merger, dated as of May 10, 2023 by and among Parent, Purchaser and the Company.
The description contained herein is for informational purposes only and is not a recommendation, an offer to buy or the solicitation of an offer to sell any of the Companys Shares. The tender offer for the Shares described in this report has not commenced. At the time the offer is commenced, Purchaser will file a tender offer statement on Schedule TO with the Securities and Exchange Commission (the SEC), and the Company will file a solicitation/ recommendation statement on Schedule 14D-9, with respect to the offer. The tender offer statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the solicitation/recommendation statement, when they become available will contain important information that should be considered carefully before any decision is made with respect to the tender offer. Free copies of the offer to purchase, the related letter of transmittal and certain other offering documents will be made available by Parent and when available may be obtained by directing a request to the Information Agent for the tender offer which will be named in the Schedule TO. In addition, all of those materials (and any other documents filed with the SEC) will be available at no charge on the SECs website at www.sec.gov.
Exhibit Index
Exhibit No. |
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99.1 | Press Release issued by Swedish Orphan Biovitrum AB (publ) on May 10, 2023. | |
99.2 | Presentation slides made available by Swedish Orphan Biovitrum AB (publ) to investors, analysts and media on May 10, 2023. |
Exhibit 99.1
Press release Stockholm, Sweden, 10 Maj, 2023 |
|
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF THAT JURISDICTION. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER OF OR THE SOLICITATION OF AN OFFER TO BUY SECURITIES IN ANY JURISDICTION.
Sobi to acquire CTI BioPharma Corp. enhancing Sobis position in rare haematology
Swedish Orphan Biovitrum AB (publ) (Sobi®) (STO:SOBI) today announced that it has entered into an agreement and plan of merger with CTI BioPharma Corp. (CTI) under which Sobi has agreed to acquire CTI, a biopharmaceutical company focused on blood related cancers and rare diseases, by means of a tender offer.
The acquisition complements and further strengthens Sobis leading haematology franchise by adding VONJO® (pacritinib), a novel oral kinase inhibitor that inhibits JAK2, IRAK1 and ACRV1, while sparing JAK1. VONJO obtained accelerated approval by the FDA in February 2022 for treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L.
Rationale of the acquisition and transaction in brief:
| Adds VONJO, a differentiated product in the treatment of myelofibrosis, specifically addressing patients with severe thrombocytopenia, an unmet medical need. |
| Highly complementary to Sobis existing portfolio, specifically Doptelet®, expands Sobis leading position in rare haematology and accelerates access for patients to both therapies globally. |
| Both VONJO and Doptelet address rare haematological platelet disorders and are prescribed by haemato-oncologists and haematologists. The acquisition accelerates Sobis strategy to build a leading franchise in rare haematology. |
| The addition of VONJO brings a uniquely differentiated therapy, serving an unmet medical need for patients suffering from myelofibrosis. |
| The acquisition is expected to accelerate Sobis revenue growth, and to improve margins, adding a commercial-stage asset in the U.S., with the potential for further expansion globally. |
| Sobi to commence a cash tender offer to acquire all issued and outstanding shares of CTI for USD 9.10 per share, corresponding to a total equity value of USD 1.7 billion (approximately SEK 17.1 billion). |
| Fully funded through committed debt financing, up to half of which is anticipated to be refinanced through a rights issue after the closing of the acquisition, with a commitment from Investor AB to subscribe for its pro rata share of the rights issue, corresponding to approximately 34.7% of the shares to be issued in the rights issue. |
Swedish Orphan Biovitrum AB (publ) (Sobi®) SE-112 76 Stockholm, Sweden Visiting address: Tomtebodavägen 23A, Solna, Sweden +46 8 697 20 00 | info@sobi.com | sobi.com |
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CTI represents a perfect fit for Sobis haematology franchise today, adding a powerful and highly differentiated new product that will make a significant difference for patients, said Guido Oelkers President and CEO of Sobi. There is a large unmet medical need within myelofibrosis, in particular for patients suffering from thrombocytopenia who are inadequately treated by existing medicines. The combination of the talented team at CTI, together with Sobis broad US and global haematology capabilities, will help get this much needed new therapy to patients faster and more effectively. The acquisition of CTI is the latest in a series of transformative transactions Sobi has conducted to build its leading rare haematology franchise.
Financial highlights
The acquisition is expected to be highly accretive to Sobis revenue and margins, starting in the near-term. Revenue and cost synergies are expected from leveraging the highly complementary nature of Sobis existing U.S. commercial operations and global sales infrastructure in haematology and rare diseases.
Sobi has obtained committed debt financing from Bank of America and Danske Bank. Sobi anticipates that up to half of the merger consideration will be refinanced through an issuance of new ordinary shares of Sobi with preferential rights for existing shareholders of Sobi, after the closing of the acquisition.
Sobis main shareholder, Investor AB, has undertaken to vote in favor of the implementation of the rights issue at an extraordinary general meeting. Investor AB has also undertaken to subscribe for its pro rata share of the rights issue, corresponding to approximately 34.7% of the shares to be issued in the rights issue. A detailed time plan and the forms for the implementation of the rights issue will be announced at a later stage.
Transaction details
Under the terms of the merger agreement, Sobi, through a wholly owned, indirect subsidiary, will initiate a tender offer to acquire all the outstanding shares of CTI for a cash purchase price of USD 9.10 per share, representing a premium of 95% based on CTIs 30-day volume-weighted average price of USD 4.67 preceding announcement of the transaction price of USD 9.10. The Board of Directors of CTI has unanimously approved the transaction and recommended that the shareholders of CTI tender their shares in the tender offer. Sobi has received an irrevocable undertaking from certain entities affiliated with BVF Partners L.P. (BVF) to tender all of their common shares, representing 6.7% of all outstanding common shares.
The closing of the tender offer will be subject to customary conditions, including the tender of shares which represent at least a majority of the total number of CTIs outstanding common shares and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Upon the successful completion of the tender offer, Sobi would acquire any shares of CTIs common stock not tendered through a second-step merger effected for the same per common share consideration. The transaction is expected to close in Q3 2023.
Advisors
Bank of America Europe DAC, Stockholm branch (BofA Securities) is acting as Sobis exclusive financial advisor in connection with the transaction and Latham & Watkins LLP is acting as legal advisor to Sobi on this transaction. Mannheimer Swartling is acting as legal advisor to Sobi in relation to the debt financing and rights issue.
Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden Visiting address: Tomtebodavägen 23A, Solna, Sweden +46 8 697 20 00 | info@sobi.com | sobi.com |
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About VONJO
VONJO is approved for the treatment of adults with intermediate- or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under FDA accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). CTI is conducting the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement. For more information, please visit https://www.ctibiopharma.com.
About CTI
CTI is a commercial biopharmaceutical company focused on the development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. CTI has one FDA-approved product, VONJO® (pacritinib), a JAK2, ACVR1, and IRAK1 inhibitor, that spares JAK1. CTI is based in Seattle, USA, and has approximately 144 employees. In 2022, CTIs revenue amounted to USD 53.9 million. For more information, please visit www.ctibiopharma.com.
Important information
The tender offer for the outstanding shares of CTI common stock referenced in this press release has not yet commenced. This document is for informational purposes only and it is neither an offer to purchase nor a solicitation of an offer to sell shares of CTIs common stock, nor is it a substitute for the tender offer materials that Sobi and Cleopatra Acquisition Corp., a Delaware corporation and indirect, wholly owned subsidiary of Sobi (Purchaser) will file with the United States Securities and Exchange Commission (the SEC), upon commencement of the tender offer. At the time any such tender offer is commenced, Sobi and Purchaser will file a tender offer statement on Schedule TO, containing an offer to purchase, a form of letter of transmittal and other related tender offer documents with the SEC, and CTI will file a Solicitation/Recommendation Statement on Schedule 14D-9 relating to such tender offer with the SEC. CTIs stockholders are strongly advised to read these tender offer materials carefully and in their entirety when they become available, as they may be amended from time to time, because they will contain important information about such tender offer that CTIs stockholders should consider prior to making any decisions with respect to such tender offer. Once filed, stockholders of CTI will be able to obtain a free copy of these documents at the website maintained by the SEC at www.sec.gov. or on CTIs website at https://www.ctibiopharma.com.
The press release is for informational purposes only and does not constitute an offer to sell or issue, or the solicitation of an offer to buy or acquire, or subscribe for, any securities in Sobi mentioned herein (collectively, the Securities) or any other financial instruments in Sobi. Any offer in respect of any Securities will only be made through the prospectus that Sobi expects to publish in due course. Offers will not be made to, and application forms will not be approved from, subscribers (including shareholders), or persons acting on behalf of subscribers, in any jurisdiction where applications for such subscription would contravene applicable laws or regulations, or would require additional prospectuses, filings, or other measures in addition to those required under Swedish law. Measures in violation of the restrictions may constitute a breach of relevant securities laws.
Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden Visiting address: Tomtebodavägen 23A, Solna, Sweden +46 8 697 20 00 | info@sobi.com | sobi.com |
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No Securities have been or will be registered under the United States Securities Act of 1933, as amended (the Securities Act), or the securities laws of any state or other jurisdiction in the United States, and may not be offered, pledged, sold, delivered or otherwise transferred, directly or indirectly, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with applicable other securities laws. There will not be any public offering of any Securities in the United States.
This announcement does not constitute an investment recommendation. The price and value of securities and any income from them can go down as well as up and investors could lose their entire investment. Past performance is not a guide to future performance. Information in this announcement cannot be relied upon as a guide to future performance.
Forward-looking statements
This press release contains forward-looking statements by Sobi that involve risks and uncertainties and reflect Sobis judgment as of the date of this press release. These forward- looking statements generally are identified by words such as believe, project, expect, anticipate, estimate, intend, strategy, future, opportunity, plan, may, should, will, would, and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements include, without limitation, statements regarding: the timing of the anticipated acquisition and when and whether the anticipated acquisition ultimately will close; the potential contributions the acquisition is expected to bring to Sobi; and the expected impact on Sobis future financial and operating results. Actual events or results may differ from Sobis expectations due to risks and uncertainties inherent in Sobis business, including, without limitation: the risk that the conditions to the closing of the transaction are not satisfied, including the risk that Sobi may not receive sufficient number of shares tendered from CTIs stockholders to complete the tender offer; litigation relating to the transaction; uncertainties as to the timing of the consummation of the transaction and the ability of each of Sobi, Purchaser or CTI to consummate the transaction; risks that the proposed transaction disrupts the current plans and operations of Sobi or CTI; the ability of CTI to retain key personnel; competitive responses to the proposed transaction; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; Sobis ability to achieve the growth prospects and synergies expected from the transaction, as well as delays, challenges and expenses associated with integrating CTI with its existing businesses; legislative, regulatory and economic developments; and other risks described in Sobis prior press releases. These forward-looking statements are made only as of the date hereof and Sobi disclaims any intent or obligation to update these forward-looking statements after the date hereof, except as required by law.
Invitation to conference call
Following the announcement of the acquisition, investors, analysts and media are invited to participate in a conference call which will include a presentation and a Q&A session today, 10 May at 15:00 CEST. The event will be hosted by Sobis President and CEO, Guido Oelkers, and the presentation will be held in English. The presentation can be followed live or afterwards on sobi.com. The slides will be made available on sobi.com.
Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden Visiting address: Tomtebodavägen 23A, Solna, Sweden +46 8 697 20 00 | info@sobi.com | sobi.com |
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To participate in the conference call, please use the following dial-in details:
Sweden: +46 (0)8 5051 0031
United Kingdom: +44 (0) 207 107 06 13
United States: +1 (1) 631 570 56 13
Other international numbers available HERE
Webcast
Participants Link:
https://media.choruscall.eu/mediaframe/webcast.html?webcastid=9tQW6rrU
Sobi
Sobi is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,600 employees across Europe, North America, the Middle East, Asia and Australia. In 2022, revenue amounted to SEK 18.8 billion. Sobis share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube.
Important notice
BofA Securities, a subsidiary of Bank of America Corporation, is acting exclusively for Sobi in connection with the transaction and for no one else and will not be responsible to anyone other than Sobi for providing the protections afforded to its clients or for providing advice in relation to the transaction.
Contacts
For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.
This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, on 10 May 2023 at 07:00 CEST.
Camilla Sandström
Interim Head of IR, External Communication and Sustainability
Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden Visiting address: Tomtebodavägen 23A, Solna, Sweden +46 8 697 20 00 | info@sobi.com | sobi.com |
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10th May, 2023 Acquisition of CTI Biopharma Expanding Sobi’s position in rare haematology Exhibit 99.2
This presentation contains forward-looking statements by Sobi that involve risks and uncertainties and reflect Sobi’s judgment as of the date of this presentation. These forward-looking statements generally are identified by words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements include, without limitation, statements regarding: the timing of the anticipated acquisition and when and whether the anticipated acquisition ultimately will close; the potential contributions the acquisition is expected to bring to Sobi; and the expected impact on Sobi’s future financial and operating results. Actual events or results may differ from Sobi’s expectations due to risks and uncertainties inherent in Sobi’s business, including, without limitation: the risk that the conditions to the closing of the transaction are not satisfied, including the risk that Sobi may not receive sufficient number of shares tendered from CTI’s stockholders to complete the tender offer; litigation relating to the transaction; uncertainties as to the timing of the consummation of the transaction and the ability of each of Sobi, Purchaser or CTI to consummate the transaction; risks that the proposed transaction disrupts the current plans and operations of Sobi or CTI; the ability of CTI to retain key personnel; competitive responses to the proposed transaction; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; Sobi’s ability to achieve the growth prospects and synergies expected from the transaction, as well as delays, challenges and expenses associated with integrating CTI with its existing businesses; legislative, regulatory and economic developments; and other risks described in Sobi’s press releases and presentations. These forward-looking statements are made only as of the date hereof and Sobi disclaims any intent or obligation to update these forward-looking statements after the date hereof, except as required by law. Forward looking statements
Additional Information and Where to Find It The Offer for all of the outstanding shares of common stock (the “Shares”) of CTI BioPharma Corp. (the “Company”) referenced in this communication has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities, nor is it a substitute for the tender offer materials that Swedish Orphan Biovitrum AB (publ), a Swedish public limited liability company (“Parent”) and Cleopatra Acquisition Corp., a Delaware corporation and indirect, wholly owned subsidiary of Parent (“Purchaser”) will file with the SEC, upon the commencement of the Offer. At the time the Offer is commenced, Parent and Purchaser will file a tender offer statement on Schedule TO, and thereafter the Company will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the Offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WILL CONTAIN IMPORTANT INFORMATION. THE COMPANY’S STOCKHOLDERS ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF THE COMPANY’S SECURITIES SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES. Holders of Shares can obtain these documents when they are filed and become available free of charge from the SEC’s website at www.sec.gov or on the Company’s website at www.ctibiopharma.com.
Guido Oelkers | Chief Executive Officer Henrik Stenqvist | Chief Financial Officer Tony Hoos | Head of R&D and Medical Affairs, Chief Medical Officer Presenters
Highly accretive to Sobi’s revenue and margins Complementary haematology reach and expertise Severe thrombocytopenic MF represents an unmet clinical need VONJO® has a differentiated profile in myelofibrosis (MF) Sobi and CTI Biopharma: Combined Leadership In Haematology
Sobi is excited to add VONJO® to its haematology franchise Business: Commercial biopharmaceutical company focused on the development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers Headquarters: Seattle, Washington Founded: 1991 Employees: 144 Publicly traded since 1997 – Market: Nasdaq; Ticker: CTIC Novel oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK1 Approved in the US for the treatment of intermediate or high-risk primary or secondary myelofibrosis with a platelet count below 50 k/μL Received accelerated approval based on spleen volume reduction Phase 3 PACIFICA confirmatory study for myelofibrosis in patients with severe thrombocytopenia in progress VONJO is the only agent specifically studied for cytopenic myelofibrosis Lead product VONJO (pacritinib)
VONJO is a great fit to Sobi’s strategy Lead in Haematology Go Global Capture the value of the pipeline Address severe unmet clinical need in a rare blood disorder Strong US potential with further opportunities in international markets Potential for expansion into new indications1 1. Future indications will need to be evaluated.
Rationale for the transaction: CTI acquisition is a transformational step for Sobi Differentiated asset by clinical data and mode of action in an area of unmet medical need Highly skilled workforce in the area of Haemato-Oncology Confidence in impactful execution Significant accelerator for Sobi’s mid-term growth in our core business Accelerate US business by creating sales synergies with Sobi franchise Internationalize the franchise in a step wise approach Develop the product beyond its current label
The acquisition of VONJO continues our journey to build the leading rare haematology franchise Leading products in Haemophilia A and B Only oral TPO-RA with no food restrictions and clean safety profile First and only JAK1-sparing inhibitor that targets both JAK2 and IRAK11 Safe and efficacious CD-19 ADC in severe DLBCL First in class C3 inhibitor and only sub-cutaneous therapy in PNH 1: Approved in the US for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythaemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 k/μL
Myelofibrosis is a rare haematological condition affecting more than 78,0001 patients worldwide ~1/3 of patients have severe thrombocytopenia5, with poor median overall survival of 15 months6 1. GlobalData 2022 analysis for diagnosed patients in 8 major markets; 2: Mehta et al., Leukemia & Lymphoma, 2014; 3: Harrison CN, et al. Leukemia 2016, Masarova et al. Leukemia Research 2020; 4: Mascaranhas et al., Leukemia, 2022, Rampal et al., Blood, 2014; 5: Masarova et al. Leukemia Research 2020, Sastov et al., Clin Lym Myelom Leuk, 2022, Masarova et al. Leukemia Research 2020; 6: Alhuraiji et al 2016, Hernández-Boluda et al 2018, Masarova et al 2018, Scotch et al 2017; 7: Verstovsek et al., NEJM, 2010 Myelofibrosis is a rare blood disease characterised by scarring of the bone marrow, as well as disruption of the normal production of blood cells Myelofibrosis is often characterised by upregulation of JAK-STAT target genes4 Myelofibrosis causes impaired blood cell production leading to anaemia and thrombocytopenia3 Large unmet medical need with limited treatment options for patients with severe thrombocytopenia7 More than 78,000 patients worldwide1, with approximately 20,000 patients in the US2
VONJO is the first FDA-approved treatment for cytopenic Myelofibrosis ~30% of Myelofibrosis patients suffer from very low platelets. This represents a particularly high unmet need due to a significantly worse prognosis1,2 Clinically, one hallmark of this disease is the strongly increased spleen size3 However, patients with very low platelets would often not be eligible for existing medicines until recently due to drug-induced cytopenias further worsening the platelet count4 VONJO represents an important novel treatment option, and the first FDA-approved medicine for severely affected Myelofibrosis patients suffering from low platelets 1: Low platelets defined as <100k/μL; 2: Alhuraiji et al 2016, Hernández-Boluda et al., Br J Hematol, 2018, Masarova et al 2018, Scotch et al., Leuk Res, 2017; Masarova et al. Leukemia Research 2020; 3: O'Reilly RA et al., West J Med, 1998; 4: Verstovsek et al., NEJM, 2010
VONJO is the first and only JAK1-sparing inhibitor that targets both JAK2 and IRAK1 Ref. CTI Company investor presentation; 1. Jarocha J, et al. Blood 2018;132(Supplement 1):2559. 2. Mascarenhas J, et al. Haematologica 2017;102(2):327-335. 3. Singer J, et al. Abstract #1874. Oral presentation ASH 2014. 4. Fisher D, et al. Leukemia 2019;33(8):1978-1995. 5. Lai HY, et al. Blood Adv 2019;3(2):122-131. 6. Balka KR, et al. J Leukoc Biol. 2019;105(2):339-351. 7. Oh S, et al. Oral Presentation ASH 2022. Abstract #628. Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1), although the clinical relevance of this activity is unknown. ACVR1= Activin A receptor type 1. Sparing JAK1 avoids drug-induced myelosuppression Inhibiting JAK2 can reduce MF-related symptoms IRAK1 inhibition can reduce MF-related symptoms VONJO's unique Mechanism of Action JAK1 JAK Pathway IRAK Pathway Not inhibited JAK2 IRAK1 Inhibited by VONJO® ACVR1 inhibition can lead to anaemia benefits NF-κB Pathway ACVR1
VONJO has shown substantial evidence on Spleen Volume Reduction in Myelofibrosis with thrombocytopenia Percentage of patients with platelet counts <50k/µL achieving ≥35% Spleen Volume Reduction (SVR) at week 24 Ref. PERSIST-2 clinical trial; FDA analysis in patients with platelets counts less than 50 k/μL VONJO has a predictable and manageable safety profile in PERSIST-2 Patients with a platelet count ≤100k/µL Potential Best in Class Benefit Only JAK inhibitor to demonstrate meaningful clinical benefit in cytopenic myelofibrosis Attractive Hematologic Profile Platelet count stability in the severe thrombocytopenia setting <50k/μL)ts less than 50 k/ 29% 3.1%
Summary of the transaction terms Consideration Financial benefit Timing All-cash offer of $9.10 per share Transaction value of $1.7bn (approximately SEK 17.1bn) on a fully-diluted basis 100% cash acquisition funded by committed debt financing Anticipate funding up to half of the transaction value via an equity raise post-closing of the acquisition by way of a rights issue where Investor AB has undertaken to subscribe for its pro rata share Expected cash flow generation to support rapid de-leveraging profile, preserving financial flexibility for future growth Sobi to initiate tender offer to acquire all outstanding shares Transaction expected to close in Q3 2023, subject to customary closing conditions Funding Expected to be accretive to Sobi’s revenue growth, and improve margin profile over the near-term Revenue and cost synergies expected from leveraging Sobi’s highly skilled and complementary US commercial infrastructure in rare haematology
Financing Overview Anticipated acquisition financing $, bn Ref. 1. Spot exchange rate as of 8 May 2023; USD/SEK 10.16 and EUR/USD 1.10. Fully committed bank financing Long-term bank debt of EUR 800m / USD 883m1 Short-term equity bridge of SEK 8bn / USD 787m1 Equity bridge to be refinanced through a rights issue post transaction close Long-term debt to be syndicated in the bank market Positions Sobi with strong balance sheet to continue executing its strategy
Differentiated asset by clinical data and mode of action in an area of unmet medical need Highly skilled workforce in the area of Haemato-Oncology Significant accelerator for Sobi’s mid-term growth in our core business Confidence in impactful execution Financially attractive Conclusion
Sobi is a trademark of Swedish Orphan Biovitrum AB (publ). © 2023 Swedish Orphan Biovitrum AB (publ) – All rights reserved Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm • Sweden www.sobi.com