On July 22, 2021 Biogen Inc. (Nasdaq: BIIB) reported second quarter 2021 financial results (Press release, Biogen, JUL 22, 2021, View Source,%24448%20million%20and%20%242.99%2C%20respectively.&text=Second%20quarter%20Non%2DGAAP%20net,%24852%20million%20and%20%245.68%2C%20respectively. [SID1234585115]).

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"We were pleased with our operational performance in the second quarter," said Michel Vounatsos, Biogen’s Chief Executive Officer. "Biogen has the market-leading portfolio of therapies for MS, has launched the first approved and market-leading therapy for SMA, and now has the first approved therapy to address a defining pathology of Alzheimer’s disease. In addition, we recently reported positive data in depression and stroke, and we look forward to the expected Phase 3 data for tofersen, the first genetically-targeted potential therapy for ALS, for which we have begun offering individual compassionate use access." Second Quarter 2021 Financial Results

• Second quarter total revenue of $2,775 million decreased 25% versus the prior year at actual currency and decreased 26% at constant currency*. o Multiple sclerosis (MS) revenue, including royalties on sales of OCREVUS, of $1,786 million decreased 24% versus the prior year at both actual and constant currency. o SPINRAZA revenue of $500 million increased 1% versus the prior year at actual currency and decreased 3% at constant currency. o ADUHELM revenue was $2 million. o Biosimilars revenue of $202 million increased 18% versus the prior year at actual currency and increased 9% at constant currency. 2 o Other revenue of $99 million decreased 76% versus the prior year at both actual and constant currency, primarily due to approximately $330 million in revenue in the second quarter of 2020 related to the license of certain manufacturingrelated intellectual property to one of our corporate partners.

• Second quarter GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. were $448 million and $2.99, respectively.

• Second quarter Non-GAAP net income and diluted EPS attributable to Biogen Inc. were $852 million and $5.68, respectively. A reconciliation of GAAP to Non-GAAP financial measures included in this news release can be found in Table 4 at the end of this news release. * Percentage changes in revenue growth at constant currency are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. The current period’s foreign currency revenue values are converted into U.S. dollars using the average exchange rates from the prior period Beginning in the second quarter of 2021 material upfront payments and premiums paid on the acquisition of common stock associated with significant collaboration and licensing arrangements along with the related transaction costs incurred are no longer excluded from Non-GAAP R&D and SG&A expenses. Non-GAAP financial results for the second quarter of 2020 have been updated to reflect the $208 million payment related to the collaboration with Sangamo Therapeutics, Inc. along with the associated transaction costs and income tax effect. o Second quarter 2021 GAAP and Non-GAAP R&D expense includes a $30 million upfront payment related to a commercialization and license agreement with Bio-Thera Solutions, Ltd. (Bio-Thera) in addition to $20 million in upfront payments related to collaboration agreements with Capsigen Inc. (Capsigen) and Ginkgo Bioworks (Ginkgo).

• Second quarter 2021 GAAP amortization and impairment of acquired intangible assets was $604 million, including an impairment charge of approximately $350 million 3 related to BIIB111 (timrepigene emparvovec) in choroideremia and a $192 million impairment charge related to BIIB112 (cotoretigene toliparvovec) in X-linked retinitis pigmentosa, both of which were based on recent data readouts. These amounts are excluded from Non-GAAP financial results.

• Second quarter 2021 GAAP and Non-GAAP collaboration profit sharing reduced our net operating expenses by $15 million, which includes a reimbursement of $85 million from Eisai Co., Ltd. (Eisai) related to the commercialization of ADUHELM in the U.S.

• Second quarter 2021 GAAP other income was $96 million, primarily driven by unrealized gains on our strategic equity investments of $154 million. Second quarter 2021 Non-GAAP other expense was $58 million, primarily driven by interest expense.

• Second quarter 2021 effective GAAP and Non-GAAP tax rates were (70%) and 16%, respectively. The second quarter 2021 effective GAAP tax rate was impacted by a deferred tax benefit associated with the accelerated approval of ADUHELM by the U.S. Food and Drug Administration (FDA). We recorded a deferred tax asset of approximately $500 million related to Neurimmune SubOne AG’s (Neurimmune) tax basis in ADUHELM, with an equal and offsetting amount assigned to noncontrolling interest, resulting in zero net impact to net income attributable to Biogen Inc.

• Second quarter 2021 GAAP and Non-GAAP income attributable to noncontrolling interest were $577 million and $84 million, respectively, which includes a milestone payment of $100 million to Neurimmune related to the launch of ADUHELM in the U.S. GAAP income attributable to noncontrolling interest also includes the offset to a deferred tax benefit related to Neurimmune’s tax basis in ADUHELM of approximately $500 million. Financial Position

• As of June 30, 2021, Biogen had $7,269 million in total debt. Cash, cash equivalents, and marketable securities totaled $3,966 million. This resulted in net debt of $3,303 million.

• In the second quarter of 2021 Biogen repurchased approximately 1.6 million shares of the Company’s common stock for a total value of $450 million. As of June 30, 2021, there was $3,550 million remaining under the share repurchase program authorized in October 2020.

• For the second quarter of 2021 the Company’s weighted average diluted shares were 150 million.

• Second quarter 2021 cash from operations was $1,227 million. Capital expenditures were $72 million, and free cash flow, defined as cash flow from operations less capit

al expenditures, was $1,155 million.This financial guidance continues to assume modest ADUHELM revenue in 2021, ramping thereafter. This guidance also continues to assume erosion of TECFIDERA and RITUXAN in the U.S. Biogen expects the decreased revenue from these high margin products to reduce its gross margin percentage compared to 2020.

Non-GAAP R&D expense is expected to be between $2.45 billion and $2.55 billion, an increase from prior guidance primarily due to an expected $125 million upfront payment in the third quarter of 2021 associated with our recently announced collaboration with InnoCare Pharma Limited (InnoCare).

This payment was not included in our prior guidance. Non-GAAP SG&A expense is expected to be between $2.6 billion and $2.7 billion, consistent with our previous guidance. This guidance continues to reflect our expectation that both Non-GAAP R&D and Non-GAAP SG&A expenses will be higher in the second half of the year than they were in the first half due to collaborations, program readouts, and investments in ADUHELM.

We expect that we will utilize a portion of the remaining share repurchase authorization of $3,550 million throughout 2021. This guidance assumes that foreign exchange rates as of June 30, 2021, will remain in effect for the remainder of the year, net of hedging activities.

On July 22, 2021 Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage platform technology that enables antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported the signature of a license and option agreement with ProfoundBio, an emerging oncology biotherapeutics company (Press release, Synaffix, JUL 22, 2021, View Source [SID1234590210]).

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The deal provides access to multiple novel linker-payload technologies developed by Synaffix and includes access to the GlycoConnect glycan conjugation and HydraSpace polar spacer technologies, both of which are known to optimize the therapeutic properties (efficacy and safety) of ADCs. Upon signature, ProfoundBio was granted non-exclusive license rights to deploy the above technologies for one therapeutic program that targets an undisclosed specific tumor associated antigen (TAA). Additionally, ProfoundBio retains license option rights to a second TAA that can be nominated later.

Under the terms of the agreement, Synaffix is eligible to receive upfront and potential milestone payments worth up to $246 million, plus tiered royalties­­ on net sales. No further financial details are disclosed.

ProfoundBio will be responsible for the research, development, manufacturing and commercialization of the ADC products. Synaffix will closely support ProfoundBio’s research activities and be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect, and HydraSpace technologies.

Baiteng Zhao, CEO of ProfoundBio said:

"Selecting the right linker-payload for each ADC is critical for success. Through our collaboration with Synaffix, we can access multiple potent ADC linker-payloads and efficiently optimize the competitive position of our therapeutic pipeline."

"With the solid experience and track record of our founding management team and a strong venture capital syndicate behind us, we are well positioned to rapidly progress multiple best-in-class and first-in-class ADC candidates to the clinic. We look forward to working closely with Synaffix to achieve this."

Peter van de Sande, CEO of Synaffix said:

"This collaboration is another example of Synaffix’ proprietary technologies helping biotech and pharma companies optimize the competitive positions of their ADC pipelines."

"The ProfoundBio team brings multiple decades of valuable ADC development experience from Seattle Genetics (now Seagen) and MSD. into our collaboration. We are looking forward to continuing our close collaboration with ProfoundBio on their emerging ADC portfolio and supporting the development of multiple ADCs into the clinic and beyond."

On July 21, 2021 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 1,433 million in the second quarter of 2021. Net trade sales were USD 770 million in the U.S. and USD 663 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC formulations, under the exclusive worldwide license to Janssen Biotech, Inc. (Janssen) to develop, manufacture and commercialize daratumumab. As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.

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About DARZALEX(daratumumab)
DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat multiple myeloma and has become a backbone therapy in the treatment of this disease. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of multiple myeloma and the first and only approved treatment for patients with light-chain (AL) amyloidosis. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). 1,2,3,4,5,6,7

Please see local country prescribing information for all labeled indication and safety information.

On July 21, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has launched Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), also known as JZP458 (Press release, Ligand, JUL 21, 2021, View Source [SID1234585015]). Rylaze, which was approved by the FDA on June 30, 2021, is a recombinant erwinia asparaginase used as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

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Under the terms of the license agreement with Jazz Pharmaceuticals, Ligand received a $2 million payment upon FDA’s acceptance for review of the product BLA and is entitled to receive a $5 million payment upon the first commercial sale following launch. Ligand is eligible to receive up to an additional $155.5 million in milestone payments and tiered low to mid-single digit royalties based on worldwide net sales of any products resulting from this collaboration, including Rylaze.

"This partnership with Jazz Pharmaceuticals is one of the core scientific programs that catalyzed our acquisition of Pfenex last year. The Rylaze commercial launch really showcases our highly productive partnership with Jazz and the exceptional ability of our Pelican Expression Technology to enable life-saving therapeutics," said John Higgins, CEO of Ligand. "The robust manufacturing afforded by Ligand’s Pelican Expression Technology combined with Jazz’s demonstrated success in development and commercialization has enabled the delivery of a high-quality recombinant asparaginase option for patients with hypersensitivity to E. coli-derived asparaginase with reliable supply."

About the Pelican Expression Technology

Pelican is a robust, validated, cost-effective and scalable platform for recombinant protein production, and is especially well-suited for complex, large-scale protein production where traditional systems are not suitable. Multiple global manufacturers have demonstrated consistent success with the platform and the technology is currently out-licensed for numerous commercial and development-stage programs. The versatility of the platform has been demonstrated in the production of enzymes, peptides, antibody derivatives and engineered non-natural proteins. Partners seek the platform as it can contribute significant value to biopharmaceutical development programs by reducing development timelines and costs for manufacturing therapeutics and vaccines. Given pharmaceutical industry trends toward large molecules with increasing structural complexities, Pelican is well positioned to meet these growing needs as the most comprehensive broadly available protein production platform in the industry. For more information, please visit www.pelicanexpression.com.

On July 21, 2021 RefleXion Medical, Inc., a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality that will one day treat all stages of cancer, reported the sale of its RefleXion X1 machine to The Center for Cancer and Blood Disorders, a free-standing cancer treatment center with 15 locations throughout northern Texas (Press release, RefleXion Medical, JUL 21, 2021, View Source [SID1234585031]).

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"We are thrilled to bring the promise of biology-guided radiotherapy to the Dallas-Fort Worth Metroplex," said Barry Russo, CEO of The Center for Cancer and Blood Disorders. "We have a long history of offering our patients the latest advances in cancer therapies, clinical trials and cancer research, and BgRT continues this convention. The multi-modality nature of the X1 will allow us to eventually offer advanced radiotherapy for all stages of solid tumor cancers, even in cancers where it has been traditionally infeasible to do so."

The RefleXion X1 machine is cleared for clinical use in stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS), intensity modulated radiotherapy (IMRT), and forms of conventional radiotherapy indicated for early-stage cancers, or palliative relief of symptoms for later-stage cancers. BgRT, currently under development, is designed to treat both early and late-stage cancers.

BgRT uses biological emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope known as a PET tracer to guide radiotherapy. As the PET tracer binds to the tumor cells, it produces emissions that signal the cancer’s location. The RefleXion X1 machine detects these emissions using PET detectors and responds in real-time to direct radiotherapy to each tumor and destroy it, even in moving tumors.

"We are gratified by the commitment and enthusiasm of the clinicians at The Center for Cancer and Blood Disorders for our RefleXion X1 platform," said Todd Powell, president and CEO at RefleXion. "This sale expands our commercial momentum into the southern United States, a large and growing market known for embracing new technologies that deliver cutting-edge patient care."

Installation of the RefleXion X1 machine, which will be located at the main campus in Fort Worth, is expected to begin in early 2022.