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 22, 2021 Hoffmann-La Roche reported that (Press release, Hoffmann-La Roche, JUL 22, 2021, View Source [SID1234585063])

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Group sales up 8%1 at constant exchange rates (CER); 5% in Swiss francs
Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars
Diagnostics Division sales grow 51% due to high demand for COVID-19 tests and strong momentum in routine testing
IFRS net income increases by 2% (-3% in Swiss francs), while core earnings per share up 6%
Highlights in the second quarter:
Pipeline: Positive study results for immunotherapy Tecentriq in early lung cancer; encouraging data strengthen Roche’s portfolio in neurosciences and hard-to-treat blood cancers
EU approvals: Tecentriq (specific type of metastatic non-small cell lung cancer), Venclyxto-based combinations (acute myeloid leukaemia) and Enspryng (neuromyelitis optica spectrum disorder, a rare autoimmune disease of the CNS)
GenMark Diagnostics: Acquisition, completed in April, broadens Roche’s molecular lab portfolio and reinforces our commitment to fight infectious diseases and antibiotic resistance
COVID-19: Additional positive study results for antibody combination Ronapreve (co-developed with Regeneron) and AT-527 (co-developed with Atea); Japan becomes first country to approve Ronapreve for the treatment of mild to moderate COVID-19; FDA Emergency Use Authorization for Actemra/RoActemra; launch of further tests reinforces Roche’s position as a global leader in COVID-19 diagnostics
Outlook for 2021 confirmed

Commenting on the Group’s performance in the first six months, Roche CEO Severin Schwan said: "We have achieved good results in the first half, primarily thanks to the demand for our new medicines and COVID-19 tests. The Pharma Division began to grow again in the second quarter. The base diagnostics business shows strong momentum. As expected, demand for COVID-19 tests peaked in the second quarter. I’m particularly excited about the significant progress we made in our product pipeline, including very promising study results for Tecentriq in early-stage lung cancer, as well as additional positive data for Evrysdi in spinal muscular atrophy and for COVID-19 medicines. Based on the good results of the first half of 2021, we confirm the outlook for the full year."

Outlook confirmed for 2021
Despite the continued strong impact of biosimilars, sales are expected to grow in the low- to mid-single digit range, at constant exchange rates. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to increase its dividend in Swiss francs further.

Group results
In the first half of the year, Group sales rose 8% (5% in CHF) to CHF 31 billion. IFRS net income increased 2% (-3% in CHF), while core earnings per share up by 6%. The appreciation of the Swiss franc against most currencies had a negative impact on the results expressed in Swiss francs compared to constant exchange rates.

Sales in the Pharmaceuticals Division were CHF 22 billion, a decrease of 3%. However, while sales in the first quarter were still strongly affected by COVID-19 (-9%), the second quarter showed signs of recovery in some regions (+4%). The ongoing impact from biosimilars, particularly in the US, resulted in a sales decrease of CHF 2.8 billion.

The new medicines (launched since 20122) continued their strong growth (+30%, or +CHF 2.6 billion). In the first six months, they generated sales of over CHF 11 billion, thus already contributing more than 50% to the division’s total sales.

In the United States, sales decreased by 8%, due to the launches of biosimilars for the cancer medicines MabThera/Rituxan, Avastin and Herceptin (combined -49% or CHF 1.7 billion) and the pandemic. This decline was partially compensated for by the new medicines – mainly Ocrevus (multiple sclerosis), Hemlibra (haemophilia), Evrysdi (spinal muscular atrophy) and Tecentriq (cancer immunotherapy). Here too, business is showing signs of recovery: after -14% in the first quarter, sales in the second quarter were stable, i.e. at the previous year’s level.

Sales in Europe grew by 4%, with new product sales more than compensating for the impact from biosimilars and the pandemic. Ronapreve, the antibody combination against COVID-19, was the key growth driver, mainly in Germany, Italy and France.

In Japan, sales were stable. Growth of recently launched medicines, such as Tecentriq and Enspryng, was offset by the impact from biosimilars and government price cuts.

Sales in the International region grew by 2%. Growth in China (+3%) was mainly due to strong sales of Perjeta, Alecensa, Tecentriq and Herceptin, partly offset by biosimilar competition for Avastin and MabThera/Rituxan. Excluding China, sales increased by 1%, mainly due to orders for Ronapreve in India, again partially offset by the impact from biosimilars, mainly in Canada and Brazil.

The Diagnostics Division achieved very strong sales growth of 51% to CHF 9 billion. The base business (i.e. routine diagnostics), which was heavily impacted by the pandemic in 2020, grew strongly: +17% in the first quarter and +31% in the second quarter. Roche’s industry-leading portfolio of COVID-19 tests contributed total sales of CHF 2.5 billion (CHF 0.7 billion in 2020); the demand for COVID-19 tests is likely to decrease in the second half of 2021.

The division recorded high sales growth in all regions: Europe, Middle East and Africa +70%, Asia-Pacific +44%, North America +25% and Latin America +77%.

In April, Roche acquired the US company GenMark Diagnostics for USD 1.9 billion. GenMark’s novel technology detects a wide range of pathogens from a single patient sample. It broadens Roche’s molecular lab portfolio, and reinforces our commitment to help control infectious diseases and antibiotic resistance.

Roche’s response to the COVID-19 pandemic
Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, more treatment options are still needed. In the second quarter, Roche and/or its partners shared positive news:

Antibody combination Ronapreve (co-developed with Regeneron): Preliminary phase III data from a University of Oxford-led trial demonstrated that the antibody combination casirivimab/imdevimab reduced the risk of death when given to patients hospitalised with severe COVID-19 who had not mounted a natural antibody response of their own. In July, Japan became the first country to approve Ronapreve for the treatment of patients with mild to moderate COVID-19.
AT-527 (co-developed with Atea): Interim results from a phase II trial indicated rapid and sustained antiviral activity against SARS-CoV-2 in hospitalised COVID-19 patients. AT-527 continues to be evaluated for the treatment and prevention of COVID-19.
Actemra/RoActemra:3 Roche’s intravenous anti-inflammation medicine received FDA Emergency Use Authorization (EUA) for the treatment of severe COVID-19 in hospitalised adults and children.
Manufacturing: Roche is currently ramping up its production capacity for AT-527, which requires a complex manufacturing process, as much as possible. For Actemra, Roche has already increased its own production capacity significantly and has been working with external manufacturers on transferring its technologies to increase the global supply further.
Roche has also reinforced its position as a world-leading supplier of COVID-19 diagnostics. In June, the SARS-CoV-2 Antigen Self Test Nasal obtained the CE mark,4 and the cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System was granted first FDA EUA for PCR testing of both symptomatic and asymptomatic individuals at the point of care (with results within 20 minutes).

On July 22, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported financial results for the second quarter ended June 30, 2021, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, JUL 22, 2021, View Source [SID1234585083]).

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"Our focus remains on completion of our Phase 1 dose escalation ReSPECT-GBM trial, which is evaluating the Company’s lead investigational drug, Rhenium-186 NanoLiposome (186RNL) in recurrent glioblastoma (GBM), expansion of our 186RNL pipeline, and GMP production of 186RNL to be available in mid-2022 for a potential registrational trial," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "We believe that the evolving clinical data in ReSPECT shows that high doses of precisely delivered beta radiation in patients with recurrent GBM is both feasible and safe. We intend to provide a comprehensive update on the data later this year."

RECENT HIGHLIGHTS

Rhenium-186 NanoLiposome ( 186 RNL), a novel radiotherapy in development for several rare cancer targets

Recurrent Glioblastoma (GBM)

The U.S. multi-center ReSPECT-GBM Phase 1 dose-finding clinical trial is designed to safely and effectively deliver high doses of radiation directly to brain tumors. Thus far, 22 patients with recurrent GBM have been treated in the ReSPECT-GBM trial across eight cohorts. Absorbed radiation doses of up to 740 Gray per tumor have been achieved without dose-limiting toxicities.
In June 2021, the Data and Safety Monitoring Board (DSMB) recommended the Company proceed to the eighth dosing cohort of the ReSPECT-GBM trial, which implemented a 40% increase in total radioactivity and volume. The first patient in the eighth cohort was treated in July 2021.
Leptomeningeal Metastases (LM)

In the second quarter of 2021, the Company received a positive response to the 186RNL pre-Investigational New Drug (IND) meeting briefing package that it submitted in the first quarter of 2021 to the U.S. Food and Drug Administration (FDA) for the treatment of LM.
The Company intends to submit an IND application to the FDA and, upon approval, begin a ReSPECT-LM Phase 1 clinical trial of 186RNL for the treatment of LM by the end of 2021.
Pediatric Brain Cancer (PBC)

In the first quarter of 2021, the Company submitted a 186RNL pre-IND meeting briefing package to the FDA for treatment of various pediatric brain cancers.
Based on the feedback from the FDA, the Company is not required to perform additional preclinical or toxicology studies and intends to submit an IND application to begin a ReSPECT-PBC Phase 1 clinical trial of 186RNL for the treatment of pediatric brain cancer in 2022.
On June 10, 2021, a poster titled, "A two-part, Phase I study of Rhenium-186 Nanoliposomes (186RNL) delivered by convection enhanced delivery (CED) for recurrent, refractory, or progressive ependymoma and high-grade glioma (HGG)" was presented at the 6th Biennial Pediatric Neuro-Oncology Research Conference. The data included a review of relevant preclinical research, the Company’s Phase 1 ReSPECT-GBM clinical trial and a proposed design for initiating a Phase I clinical trial in PBC.
Commercial Manufacturing and Supply Chain

Thus far in 2021, the Company has entered into four collaboration agreements to support the Company’s process development and analytical chemistry activities, as well as to strengthen its commercial supply chain in compliance with current good manufacturing practices (cGMP), for the manufacture of commercial grade 186RNL.
EXPECTED UPCOMING CLINICAL MILESTONES AND EVENTS FOR 2021

During the remainder of 2021, the Company intends to focus on the following key business objectives and milestones:

Complete enrollment of the eighth cohort in the company’s ReSPECT-GBM Phase 1 clinical trial.
Complete pivotal trial planning in conjunction with the FDA feedback for 186RNL in recurrent GBM.
Submit IND applications to initiate clinical investigation of 186RNL for LM and PBC.
Complete planned 2021 CMC activities such that cGMP 186RNL will be available in mid-2022.
SECOND QUARTER 2021 FINANCIAL RESULTS

As of June 30, 2021, the Company’s cash balance was $17.2 million, compared to $8.3 million as of December 31, 2020.
Total operating expenses for the second quarter of 2021 were $2.6 million, compared to total operating expenses of $2.5 million for the same quarter in 2020.
Net loss for the second quarter of 2021 was $2.8 million, or $(0.25) per share, compared to a net loss of $1.8 million, or $(0.45) per share, for the same quarter in 2020. The increase in net loss is primarily due to the gain in the fair value of warrants in the second quarter of 2020.
Second Quarter 2021 Results Conference Call

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

Event: Plus Therapeutics Second Quarter 2021 Results Conference Call
Date: Thursday, July 22, 2021
Time: 5:00 p.m. Eastern Time
Live Call: 877-876-9174 (toll free); 785-424-1669 (Intl.); Conference ID: PSTVQ221
The webcast can be accessed live via the investor section of the Plus Therapeutics website at ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.

On July 22, 2021 DURECT Corporation (Nasdaq: DRRX) reported that it will report its second quarter 2021 financial results and host a conference call after the market close on Thursday, July 29, 2021 (Press release, DURECT, JUL 22, 2021, https://investors.durect.com/news-releases/news-release-details/durect-corporation-announce-second-quarter-2021-financial [SID1234585100]).

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