Latest news with #Ayrmid
Yahoo
27-05-2025
- Business
- Yahoo
BioLineRx Reports First Quarter 2025 Financial Results and Provides Corporate Update
- Reports continued progress in the evaluation of assets for potential in-licensing and development in the areas of oncology and rare disease - - New data from pilot phase of ongoing CheMo4METPANC Phase 2b combination trial of motixafortide in PDAC, sponsored by Columbia University, to be presented at upcoming 2025 ASCO Annual Meeting – - APHEXDA performing well under Ayrmid stewardship - - Management to host conference call today, May 27th, at 8:30 am EDT - TEL AVIV, Israel, May 27, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update. "Following our announcement last November that we out-licensed APHEXDA®, our FDA-approved stem cell mobilization agent, to Ayrmid Ltd., we have been actively evaluating new assets in the areas of oncology and rare disease where we can leverage our drug development and regulatory expertise to bring new medicines to market," said Philip Serlin, Chief Executive Officer of BioLineRx. "I remain optimistic that we will announce a meaningful transaction this year." "At the same time, APHEXDA is performing well under the stewardship of Ayrmid, and I believe this license agreement will contribute significant long-term value to our company," Mr. Serlin concluded. Financial Updates Completed financing in January 2025 raising gross proceeds of $10 million. Successfully reduced operating expense run rate by over 70% beginning January 1, 2025, through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the Company's U.S. commercial operations in Q4 2024, as well as additional headcount and other operating expense reductions. Reaffirms cash runway through the second half of 2026. APHEXDA Performance Update APHEXDA generated sales of $1.4 million in the first quarter of 2025, providing royalty revenues to the Company of $0.3 million. Clinical Updates Motixafortide Pancreatic Ductal Adenocarcinoma (mPDAC) Additional trial sites were activated for the CheMo4METPANC Phase 2b clinical trial, which is expected to have a positive impact on patient recruitment. Full enrollment in the randomized trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx, is planned for completion in 2027, with a prespecified interim analysis planned when 40% of progression free survival (PFS) events are observed. An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial has been accepted for a poster presentation at the 2025 ASCO Annual Meeting on Saturday, May 31st. Key highlights include: Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response. An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination. Sickle Cell Disease (SCD) & Gene Therapy Enrollment is continuing into the multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children's Research Hospital. Reported continued progress of a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial is sponsored by Washington University School of Medicine in St. Louis. Financial Results for the Quarter Ended March 31, 2025 Revenues for the three-month period ended March 31, 2025 were $0.3 million, a decrease of $6.6 million, compared to revenues of $6.9 million for the three-month period ended March 31, 2024. The significant decrease in revenues from 2024 to 2025 reflects the one-time revenues recorded in 2024 relating to the out-licensing transaction with Gloria during the fourth quarter of 2023, as well as the change in the Company's operations following the out-licensing of APHEXDA to Ayrmid during the fourth quarter of 2024. The revenues in 2025 reflect the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The revenues in 2024 primarily reflect a portion of the up-front payment received by the Company and a milestone payment achieved under the license agreement with Gloria, which collectively amounted to $5.9 million, as well as $0.9 million of net revenues from product sales of APHEXDA in the U.S. Cost of revenues for the three-month period ended March 31, 2025 was immaterial, compared to cost of revenues of $1.5 million for the three-month period ended March 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects sub-license fees on a milestone payment received under the Gloria license agreement and royalties on net product sales of APHEXDA in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales. Research and development expenses for the three months ended March 31, 2025 were $1.6 million, a decrease of $0.9 million, or 34.9%, compared to $2.5 million for the three months ended March 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount. There were no sales and marketing expenses for the three months ended March 31, 2025, compared to $6.3 million for the three months ended March 31, 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction. General and administrative expenses for the three months ended March 31, 2025 were $1.0 million, a decrease of $0.4 million, or 28.6%, compared to $1.4 million for the three months ended March 31, 2024. The decrease resulted primarily from a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses. Net non-operating income for the three months ended March 31, 2025 was $7.6 million, compared to net non-operating income of $4.5 million for the three months ended March 31, 2024. Non-operating income for both periods primarily relates to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company's share price. Net financial expenses for the three months ended March 31, 2025 were $0.1 million, compared to net financial expenses of $0.4 million for the three months ended March 31, 2024. Net financial expenses for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits. Net income for the quarter ended March 31, 2025 was $5.1 million, compared to $0.7 million for the quarter ended March 31, 2024. As of March 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $26.4 million Conference Call and Webcast Information To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until May 29, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally. About BioLineRx BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's first approved product is APHEXDA® (motixafortide), with an indication in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, which is being developed and commercialized by Ayrmid Ltd. (globally, excluding Asia) and Gloria Biosciences (in Asia). BioLineRx is utilizing its end-to-end expertise in development, regulatory affairs and manufacturing to advance its innovative pipeline and ensure life-changing discoveries move beyond the bench to the bedside. Learn more about who we are, what we do, and how we do it at or on Twitter and LinkedIn. Forward Looking Statement Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential success of the license agreement with Ayrmid and the commercial potential of motixafortide, expectations with regard to clinical trials of motixafortide, the expected cash runway, and BioLineRx's business strategy. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials, whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; and statements as to the impact of the political and security situation in Israel on BioLineRx's business, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2025. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law. BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED)December 31,March 31,20242025in USD thousands AssetsCURRENT ASSETSCash and cash equivalents 10,4369,036 Short-term bank deposits 9,12617,333 Trade receivables 2,4761,469 Prepaid expenses 443312 Other receivables 1,478452 Inventory 3,1453,315 Total current assets 27,10431,917 NON-CURRENT ASSETSProperty and equipment, net 386299 Right-of-use assets, net 967863 Intangible assets, net 10,44910,431 Total non-current assets 11,80211,593 Total assets 38,90643,510 Liabilities and equityCURRENT LIABILITIESCurrent maturities of long-term loan 4,4794,684 Accounts payable and accruals: Trade 5,5834,693 Other 3,1311,751 Current maturities of lease liabilities 522440 Warrants 1,6912,462 Total current liabilities 15,40614,030 NON-CURRENT LIABILITIESLong-term loan, net of current maturities 8,9587,633 Lease liabilities 1,081985 Total non-current liabilities 10,0398,618 COMMITMENTS AND CONTINGENT LIABILITIES Total liabilities 25,44522,648 EQUITYOrdinary shares 38,09762,570 Share premium 353,693333,627 Warrants 5,3673,686 Capital reserve 17,54717,095 Other comprehensive loss (1,416)(1,416) Accumulated deficit (399,827)(394,700) Total equity 13,46120,862 Total liabilities and equity 38,90643,510 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED)Three months ended March 31,20242025in USD thousands REVENUES: License revenues 5,931255 Product sales, net 924- Total revenues 6,855255 COST OF REVENUES (1,455)(34) GROSS PROFIT 5,400221 RESEARCH AND DEVELOPMENT EXPENSES (2,494)(1,623) SALES AND MARKETING EXPENSES (6,342)- GENERAL AND ADMINISTRATIVE EXPENSES (1,386)(989) OPERATING LOSS (4,822)(2,391) NON-OPERATING INCOME (EXPENSES), NET 4,4907,644 FINANCIAL INCOME 565294 FINANCIAL EXPENSES (929)(420) NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) (696)5,127in USD EARNINGS )LOSS( PER ORDINARY SHARE - BASIC AND DILUTED (0.00)0.00 WEIGHTED AVERAGE NUMBER OF SHARES USED INCALCULATION OF EARNINGS )LOSS( PER ORDINARY SHARE 1,086,589,1652,217,728,234 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED) Ordinary shares Share pre-mium Warrants Capital re-serveOther compre-hensive lossAccumulated deficit Totalin USD thousands BALANCE AT JANUARY 1, 2024 31,355355,4821,40817,000(1,416)(390,606)13,223 CHANGES FOR THREE MONTHS ENDED MARCH 31, 2024:Share-based compensation ---533--533 Comprehensive loss for the period -----(696)(696) BALANCE AT MARCH 31, 2024 31,355355,4821,40817,533(1,416)(391,302)13,060 Ordinary shares Share pre-mium Warrants Capital re-serveOther compre-hensive loss Accumulated deficit Totalin USD thousands BALANCE AT JANUARY 1, 2025 38,097353,6935,36717,547(1,416)(399,827)13,461 CHANGES FOR THREE MONTHS ENDED MARCH 31, 2025:Issuance of share capital, pre-funded warrants and warrants, net 16,415(14,836)501---2,080 Pre-funded warrants exercised 8,058(5,876)(2,182)---- Employee stock options expired -646-(646)--- Share-based compensation ---194--194 Comprehensive income for the period -----5,1275,127 BALANCE AT MARCH 31, 2025 62,570333,6273,68617,095(1,416)(394,700)20,862 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED)Three months ended March 31,20242025in USD thousands CASH FLOWS - OPERATING ACTIVITIESComprehensive income (loss) for the period (696)5,127 Adjustments required to reflect net cash used in operating activities (see appendix below) (13,413)(7,718) Net cash used in operating activities (14,109)(2,591) CASH FLOWS - INVESTING ACTIVITIESInvestments in short-term deposits -(12,307) Maturities of short-term deposits 16,7194,130 Purchase of property and equipment (32)- Net cash provided by (used in) investing activities 16,687(8,177) CASH FLOWS - FINANCING ACTIVITIESIssuance of share capital, pre-funded warrants and warrants, net of issuance costs -10,697 Repayments of loan (765)(1,120) Repayments of lease liabilities (129)(127) Net cash provided by (used in) financing activities (894)9,450 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 1,684(1,318) CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD 4,25510,436 EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS 51(82) CASH AND CASH EQUIVALENTS - END OF PERIOD 5,9909,036 BioLineRx Ltd. APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED)Three months ended March 31,20242025in USD thousands Adjustments required to reflect net cash used in operating activities: Income and expenses not involving cash flows: Depreciation and amortization 897165 Exchange differences on cash and cash equivalents (51)82 Fair value adjustments of warrants (4,444)(8,311) Warrant issuance costs -702 Share-based compensation 533194 Interest on short-term deposits (163)(30) Interest on loan 610- Exchange differences on lease liabilities (25)(7)(2,643)(7,205) Changes in operating asset and liability items:Decrease (increase) in trade receivables (2,474)1,007 Increase in inventory (936)(170) Decrease in prepaid expenses and other receivables 811,157 Decrease in accounts payable and accruals (3,511)(2,507) Decrease in contract liabilities (3,930)-(10,770)(513)(13,413)(7,718)Supplemental information on interest received in cash 357236 Supplemental information on interest paid in cash 255361 Supplemental information on non-cash transactions: Changes in right-of-use asset and lease liabilities 3244 Warrant issuance costs -237 Logo: Contacts: United StatesIrina KofflerLifeSci Advisors, LLCIR@ IsraelMoran MeirLifeSci Advisors, LLCmoran@ View original content: SOURCE BioLineRx Ltd.
Yahoo
17-04-2025
- Business
- Yahoo
Bluebird bio reaffirms Carlyle deal as Ayrmid misses deadline
Bluebird bio (bluebird) has reaffirmed its support for a proposed acquisition by Carlyle and SK Capital after rival bidder Ayrmid failed to deliver a binding offer or secure financing by the extended deadline. The announcement marks the second time Ayrmid has initiated discussions with bluebird without producing a fully financed proposal. Bluebird said it had engaged with Ayrmid for three weeks following the private equity firm's unsolicited bid in March, including extending the original deadline to allow more time for due diligence and deal structuring. However, Ayrmid did not submit a definitive proposal by the agreed-upon 15 April cut-off date and has yet to secure the necessary capital to proceed. As a result, bluebird's board of directors is reiterating its unanimous support for the acquisition agreement with Carlyle and SK Capital, which was first announced in February 2025. The board is urging shareholders to tender their shares by the updated deadline of 2 May, extending the previous expiration date of 18 April. bluebird's board chairman Mark Vachon said: 'Ayrmid's proposal remains highly conditional. bluebird has engaged with Ayrmid on two separate occasions—neither of which has resulted in a binding or fully-financed offer. The board unanimously reaffirms its support of the previously announced agreement with Carlyle and SK Capital in the strongest possible terms.' Bluebird has been under significant financial pressure for several years. The company currently faces the risk of defaulting on a $175m loan from Hercules Capital, secured in 2024 to support ongoing operations. Without a new capital injection, the board said, the company's liquidity position remains precarious. Carlyle and SK Capital's proposal offers $3 per share in cash, along with a potential additional payment of $6.84 per share if certain clinical and commercial milestones are met. Ayrmid's offer, disclosed last month, proposed $4.50 per share upfront and the same milestone-based payout structure. However, bluebird confirmed that Ayrmid has not demonstrated access to committed funding. bluebird noted that Ayrmid is continuing to seek financing and may provide further updates in the coming days. bluebird's financial position has deteriorated over time, despite achieving several key regulatory milestones. The company currently markets three US Food and Drug Administration (FDA)-approved gene therapies – Zynteglo (betibeglogene autotemcel) for transfusion-dependent beta-thalassemia, Skysona (elivaldogene autotemcel) for cerebral adrenoleukodystrophy, and Lyfgenia (lovotibeglogene autotemcel) for sickle cell disease – but has struggled with slow uptake, high costs, and reimbursement hurdles. In 2023, the company suffered a major setback when the FDA denied a priority review voucher (PRV) for Lyfgenia. Bluebird had already arranged to sell the voucher to Novartis for $103m, but the agency ruled that the therapy's active ingredient had previously been used in Zynteglo, for which the company had already received a PRV in 2022. The loss of the expected funds deepened bluebird's financial strain. To fill the gap, bluebird pursued emergency financing through a $150m public stock offering underwritten by Goldman Sachs and JP Morgan, as well as up to $100m in receivables financing from Alterna Capital Solutions. The company has also undergone repeated cost-cutting efforts, including workforce reductions of 30% in 2022 and an additional 25% last year. Despite these efforts, bluebird's therapies continue to face stiff competition. Lyfgenia is priced at $3.1m per patient, while a competing treatment, Casgevy (exagamglogene autotemcel) from Vertex Pharmaceuticals and CRISPR Therapeutics, is listed at $2.2m. Both therapies were approved on the same day in December 2023 to treat sickle cell disease. Going public in 2013, bluebird has seen its stock decline sharply in recent years. Following the 16 April update, shares closed down by 7%. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. "Bluebird bio reaffirms Carlyle deal as Ayrmid misses deadline" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
16-04-2025
- Business
- Yahoo
bluebird bio confirms that Ayrmid, Ltd. has not delivered a binding offer or obtained necessary financing despite extensive engagement
bluebird Board reaffirms unanimous recommendation in support of transaction with Carlyle and SK Capital and recommends all stockholders tender into the current agreement by May 2, 2025 SOMERVILLE, Mass., April 16, 2025--(BUSINESS WIRE)--bluebird bio, Inc. (NASDAQ: BLUE) ("bluebird" or "the Company") today announced that after three weeks of engagement, including a timeline extension, Ayrmid Ltd. ("Ayrmid") has not submitted a binding proposal to acquire bluebird and has not obtained necessary financing. In consultation with its financial and legal advisors, the bluebird Board of Directors (the "Board") reaffirms its recommendation in support of the transaction with Carlyle and SK Capital and recommends all stockholders tender into the current agreement by May 2, 2025. "Ayrmid's proposal remains highly conditional, despite an extension to the previously agreed-upon timeline to complete confirmatory diligence and submit a binding offer," said Mark Vachon, chairman of the bluebird bio Board of Directors. "bluebird has engaged with Ayrmid on two separate occasions—neither of which has resulted in a binding or fully-financed offer. After careful consideration with our financial and legal advisors, discussions with Hercules Capital, and taking into account that absent a significant infusion of capital, bluebird continues to be at significant risk of defaulting on its loan covenants, the Board unanimously reaffirms its support of the previously announced agreement with Carlyle and SK Capital in the strongest possible terms." Background on the Board's Recommendation As announced on February 21, 2025, bluebird entered into a definitive agreement (the "Merger Agreement") with funds managed by global investment firms Carlyle and SK Capital, LP to be acquired and taken private for $3.00 per share in cash and a one-time contingent value right of $6.84 per share payable upon achievement of a net sales milestone, contingent upon certain offer conditions. The Board unanimously approved the agreement following a comprehensive review of bluebird's strategic alternatives that included meeting with more than 100 potential investors and partners over a period of five months, and a third and final denial by the Federal Drug Administration of bluebird's appeal for a priority review voucher. After commencing the tender offer with Carlyle and SK Capital, bluebird subsequently received an unsolicited non-binding written proposal from Ayrmid to acquire bluebird for an upfront cash payment of $4.50 per share and a one-time contingent value right of $6.84 per share payable upon achievement of a net sales milestone. The Ayrmid Proposal was subject to significant conditions and further negotiations between the parties, including confirmatory diligence. Consistent with its fiduciary duties, bluebird and the Board agreed to a two-week period of confirmatory diligence with Ayrmid to conclude with submission of a binding offer ready for signature. On April 11, 2025, at the request of Ayrmid, bluebird agreed to extend this period by four additional days. Ayrmid did not deliver a binding offer at the conclusion of that period and also acknowledged that it had not obtained necessary financing for its proposal. Ayrmid indicated they are continuing to pursue financing and expected to provide an update in the coming week. In addition to the most recent three-week diligence period Ayrmid was also party to the strategic process prior to announcement of the agreement with Carlye and SK Capital. In light of Ayrmid's failure to deliver a binding offer after three weeks of engagement, or as part of the earlier strategic review process, the Board reiterates its unanimous recommendation in support of the transaction with Carlyle and SK Capital. In making this determination, the Board considered that absent a significant infusion of capital, bluebird continues to be at significant risk of defaulting on its loan covenants and the transaction with Carlyle and SK Capital Partners is the only currently viable solution to generate value for stockholders. About bluebird bio Founded in 2010, bluebird has been setting the standard for gene therapy for more than a decade—first as a scientific pioneer and now as a commercial leader. bluebird has an unrivaled track record in bringing the promise of gene therapy out of clinical studies and into the real-world setting, having secured FDA approvals for three therapies in under two years. Today, we are proving and scaling the commercial model for gene therapy and delivering innovative solutions for access to patients, providers, and payers. With a dedicated focus on severe genetic diseases, bluebird has the largest and deepest ex-vivo gene therapy data set in the field, with industry-leading programs for sickle cell disease, ß-thalassemia, and cerebral adrenoleukodystrophy. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward. bluebird continues to forge new paths as a standalone commercial gene therapy company, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds. ADDITIONAL INFORMATION AND WHERE TO FIND IT This communication is not an offer to buy nor a solicitation of an offer to sell any securities of bluebird. The solicitation and the offer to buy shares of bluebird's common stock is being made pursuant to a Tender Offer Statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials, that were filed by Parent and Merger Sub with the SEC on March 7, 2025. In addition, bluebird has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer with the SEC on March 7, 2025. The tender offer materials and the Solicitation/Recommendation statement, as they may be amended from time to time, contain important information that should be read carefully when they become available and considered before any decision is made with respect to the tender offer. Investors will be able to obtain a free copy of these materials and other documents filed by Parent, Merger Sub and bluebird with the SEC at the website maintained by the SEC at Investors may also obtain, at no charge, copies of these materials and other documents by calling Innisfree M&A Incorporated, the information agent for the Offer, toll-free at (877) 825-8793 for stockholders or by calling collect at (212) 750-5833 for banks or brokers. INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THESE DOCUMENTS, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 OF BLUEBIRD AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER. Forward-Looking Statements The statements included in this press release that are not a description of historical facts are forward-looking statements. Words or phrases such as "believe," "may," "could," "will," "estimate," "continue," "anticipate," "intend," "seek," "plan," "expect," "should," "would" or similar expressions are intended to identify forward-looking statements. The forward-looking statements are based on bluebird's current beliefs and expectations and include, but are not limited to: statements regarding beliefs about the potential benefits of the transaction contemplated by the Merger Agreement; the planned completion and timing of the transaction contemplated by the Merger Agreement; statements regarding bluebird's future results of operations and financial position; bluebird's expectations with respect to the commercialization of its products, including without limitation, patient demand, the timing and amount of revenue recognition; and bluebird's ability to establish favorable coverage for its therapies. Risks and uncertainties that could cause results to differ from expectations include: uncertainties as to the timing and completion of the Offer and the Merger; uncertainties as to the percentage of bluebird stockholders tendering their shares in the Offer; the possibility that competing offers will be made; the possibility that various closing conditions for the Offer or the Merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable regulatory and/or governmental entities (or any conditions, limitations or restrictions placed on such approvals); risks relating to bluebird's liquidity during the pendency of the Offer and the Merger or in the event of a termination of the Merger Agreement; risks that the milestone related to the contingent value right is not achieved; the effects of disruption caused by the transaction making it more difficult to maintain relationships with employees, collaborators, vendors and other business partners; risks related to diverting management's attention from bluebird's ongoing business operations; the risk that stockholder litigation in connection with the transactions contemplated by the Merger Agreement may result in significant costs of defense, indemnification and liability; delays and challenges in bluebird's commercialization and manufacturing of its products, including challenges in manufacturing vector for ZYNTEGLO and SKYSONA to meet current demand; the internal and external costs required for bluebird's ongoing and planned activities, and the resulting impact on expense and use of cash, has been, and may in the future be, higher than expected, which has caused bluebird, and may in the future cause bluebird, to use cash more quickly than it expects or change or curtail some of its plans or both; substantial doubt exists regarding bluebird's ability to continue as a going concern; bluebird's expectations as to expenses, cash usage and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than bluebird's assumptions; the risk that additional funding may not be available on acceptable terms, or at all; risks related to bluebird's loan agreement, including the risk that operating restrictions could adversely affect bluebird's ability to conduct its business, the risk that bluebird will not achieve milestones required to access future tranches under the agreement, and the risk that bluebird will fail to comply with covenants under the agreement, including with respect to required cash and revenue levels, which could result in an event of default; the risk that the efficacy and safety results from bluebird's prior and ongoing clinical trials will not continue or be seen in the commercial context; the risk that the QTCs experience delays in their ability to enroll or treat patients; the risk that bluebird experiences delays in establishing operational readiness across its supply chain; the risk that there is not sufficient patient demand or payer reimbursement to support continued commercialization of bluebird's therapies; the risk of insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation, including the risk of hematologic malignancy; the risk that bluebird's products, including LYFGENIA, will not be successfully commercialized; and other risks and uncertainties pertaining to bluebird's business, including the risks and uncertainties detailed in bluebird's prior filings with the SEC, including under the heading "Risk Factors" in bluebird's Annual Report on Form 10-K for the year ended December 31, 2024, and any subsequent Quarterly Reports on Form 10-Q filed with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update these statements to reflect events or circumstances after the date hereof, except as required by law. View source version on Contacts Investors: Courtney O'Leary978-621-7347coleary@ Media: Jess Sign in to access your portfolio
Reuters
29-03-2025
- Business
- Reuters
Bluebird bio receives non-binding bid for up to $110.5 million
March 28 (Reuters) - Gene therapy maker bluebird bio (BLUE.O), opens new tab said on Friday it had received a non-binding offer from peer Ayrmid for up to $110.5 million, sending its shares up 9.8% at $4.40 in extended trading. Bluebird bio, which has been facing a cash crunch, first raised going-concern doubts three years ago. It laid off a quarter of its workforce last year to focus on launching three gene therapies, including Lyfgenia for sickle cell disease, which has had slow uptake. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Ayrmid, the parent company of cell therapy developer Gamida Cell, offered to acquire bluebird for $4.50 per share upfront, totalling about $43.8 million, according to Reuters calculations using data compiled by LSEG. The privately held UK company also offered an additional $6.84 per share, representing about $66.6 million, contingent upon bluebird achieving certain sales milestones. In February, bluebird bio said it had agreed to be taken private by Carlyle Group (CG.O), opens new tab and SK Capital Partners, for $3 per share upfront along with the same $6.84 per share, contingent upon it achieving certain sales milestones. Bluebird said its board is reviewing the Ayrmid proposal in consultation with its legal and financial advisors, and the board has not changed its recommendation in support of the Carlyle and SK Capital Partners deal.
