On August 5, 2021 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported financial results for the second quarter ended June 30, 2021 and provided recent corporate updates (Press release, Bicycle Therapeutics, AUG 5, 2021, View Source [SID1234585901]).

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"We have made significant progress executing on our ongoing company-sponsored clinical programs over the first half of the year and, looking forward, intend to announce interim clinical data from the Phase I portion of our Phase I/II clinical trials of BT5528 and BT8009, along with the expected Phase I/II BT7840 trial initiation, in the second half of the year," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "Additionally, we believe our recent license and collaboration agreement with Ionis provides further validation for our contention that Bicycles have the potential to become a leading technology for the development of precision medicines. We remain well-funded and look forward to announcing multiple upcoming key clinical milestones in the second half of the year."

Second Quarter 2021 and Recent Highlights

Entered into an Exclusive License and Collaboration Agreement with Ionis Pharmaceuticals to Develop Targeted Oligonucleotide Therapeutics. In July 2021, Ionis exercised its option under the terms of a December 2020 evaluation and option agreement and entered into an exclusive worldwide license and collaboration agreement for tissue-targeted delivery of oligonucleotide therapeutics using Bicycles with high affinity to the transferrin receptor (TfR1). Bicycle received $45 million upfront, which included a license fee, an option fee, and an $11 million equity investment. Bicycle is also eligible to receive development, regulatory and commercial milestone payments and royalties for programs developed under the collaboration.
Continued to Strengthen the Balance Sheet in the Second Quarter of 2021. The Company recognized gross proceeds from Bicycle’s at-the-market (ATM) offering program during the second quarter of 2021 totaling $14.4 million as of June 30, 2021, with an additional $30.8 million received in July 2021. Cash as of June 30, 2021 does not include $42 million of proceeds from the Ionis license and collaboration agreement or net proceeds from the ATM offering program received subsequent to the end of the second quarter of 2021.
Financial Results

Cash was $198.7 million as of June 30, 2021, compared to $136.0 million as of December 31, 2020. The increase in cash during the first six months of 2021 is primarily due to net proceeds of $72.8 million from the ATM offering program and net proceeds of $15.0 million from the debt facility with Hercules Capital, Inc., offset by cash used in operating activities. Cash of $198.7 million at June 30, 2021 is expected to provide financial runway through multiple clinical milestones and into 2024.
Research and development expenses were $11.7 million for the three months ended June 30, 2021, compared to $8.0 million for the three months ended June 30, 2020. The increase in expense of $3.7 million for the three months ended June 30, 2021 as compared to the same period in the prior year was primarily due to increased clinical program expenses for BT8009, a second-generation Bicycle Toxin Conjugate (BTC) targeting Nectin-4, increased other unallocated discovery and platform related expenses due to the timing of development activities, and increased personnel-related expenses, including $0.6 million of incremental non-cash share-based compensation expense.
General and administrative expenses were $7.3 million for the three months ended June 30, 2021, compared to $6.2 million for the three months ended June 30, 2020. The increase of $1.1 million for the three months ended June 30, 2021 as compared to the same period in the prior year was primarily due to an increase in personnel-related costs, including $0.7 million of incremental non-cash share-based compensation expense, offset by a decrease in professional and consulting fees.
Net loss was $17.9 million, or $(0.74) basic and diluted net loss per share, for the three months ended June 30, 2021, compared to net loss of $12.1 million, or $(0.67) basic and diluted net loss per share for three months ended June 30, 2020.

On August 5, 2021 Cardinal Health (NYSE: CAH) reported that fourth-quarter fiscal 2021 revenue increased 16% to $42.6 billion (Press release, Cardinal Health, AUG 5, 2021, View Source [SID1234585900]). This increase includes the favorable prior year comparison from reduced pharmaceutical demand related to COVID-19. Fiscal year 2021 revenues were $162.5 billion, a 6% increase from fiscal year 2020.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

Both GAAP and Non-GAAP operating earnings during the fourth quarter and fiscal year 2021 were adversely impacted by a $197 million COVID-19-related inventory reserve related to certain Personal Protective Equipment (PPE) in the Medical segment. Fourth-quarter and full year GAAP diluted earnings per share (EPS) were also negatively impacted by $149 million and $1.17 billion pre-tax charges, respectively, related to opioid lawsuits brought by states and local governmental entities.

Fourth-quarter GAAP operating earnings decreased 40% to $162 million and GAAP diluted EPS decreased to $0.40. Non-GAAP operating earnings decreased 28% to $320 million and Non-GAAP diluted EPS decreased 26% to $0.77 in the quarter.

Fiscal year 2021 GAAP operating earnings were $472 million and non-GAAP operating earnings decreased 5% to $2.3 billion. GAAP diluted EPS for fiscal year 2021 were $2.08, while non-GAAP diluted EPS were $5.57.

"We’re disappointed with our fourth quarter results. Throughout the past year we have been taking action to drive performance, and we will continue to move forward with urgency," said Mike Kaufmann, CEO of Cardinal Health. "For example, we divested the Cordis business, extended our Red Oak Sourcing agreement with CVS Health, identified $250 million of additional cost savings opportunities and made important leadership changes. With the actions we’ve taken to date and our plans for fiscal year 2022, we feel confident in our strategy, and are encouraged by the tailwinds behind our growth areas and strong cash flow generation."

COVID-19
The COVID-19 pandemic adversely affected fiscal year 2021 results. The company estimates that COVID-19 had a total net negative impact to both GAAP and non-GAAP operating earnings of approximately $300 million in fiscal year 2021, or approximately $200 million on a year-over-year basis.

Fourth-quarter revenue for the Pharmaceutical segment increased 15% to $38.3 billion driven primarily by sales growth from large Pharmaceutical Distribution and Specialty Solutions customers. This increase also includes the favorable prior year comparison from reduced pharmaceutical demand related to COVID-19.

Pharmaceutical segment profit was flat at $358 million in the fourth quarter. This reflects COVID-19-related volume recovery in the Nuclear and Precision Health Solutions business, offset by the adverse impact of Pharmaceutical Distribution customer contract renewals.

Fourth-quarter revenue for the Medical segment increased 23% to $4.2 billion, driven by a net positive impact from COVID-19 on products and distribution. This increase was primarily due to a recovery in elective procedure volumes and the positive pricing impact of PPE.

Medical segment loss of $63 million in the fourth quarter was due to an adverse impact from COVID-19. This was primarily due to an inventory reserve on certain PPE products, partially offset by a recovery in elective procedure volumes. Additionally, benefits from cost savings initiatives were offset by elevated supply chain costs.

Tax rate
The GAAP effective tax rates for the fourth quarter of fiscal year 2021, fiscal year 2021 and fiscal year 2020 included net tax benefits related to the treatment of the tax impacts of the opioid litigation charges. Included in the GAAP effective tax rate for fiscal 2021 was a benefit from the net operating loss carryback primarily related to a self-insurance pre-tax loss.

Fiscal year 2022 non-GAAP EPS guidance reflects a net tailwind related to COVID-19 of approximately $200 million compared to the prior year. Additionally, the company expects incremental investments of approximately $120 million in technology enhancements to drive growth and efficiencies, as well as an approximate $80 million negative impact to operating earnings due to the Cordis divestiture. Fiscal year 2022 non-GAAP EPS guidance reflects share repurchases in the range of $500 million to $1.0 billion.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Recent highlights

Cardinal Health amended its Red Oak Sourcing agreement with CVS Health to extend the term of the generic pharmaceutical sourcing venture through June 2029.
Cardinal Health announced the completion of the previously announced sale of Cardinal Health’s Cordis business to Hellman & Friedman for a sale price of approximately $1 billion.
Cardinal Health, along with pharmaceutical distribution peers, announced that they have negotiated a comprehensive proposed settlement agreement which, if all conditions are satisfied, would result in the settlement of a substantial majority of opioid lawsuits filed by state and local governmental entities.
Cardinal Health Board of Directors approved a quarterly dividend of $0.4908 per share. The dividend will be payable on October 15, 2021 to shareholders of record at the close of business on October 1, 2021.
Cardinal Health has been named one of the 2021 Best Companies for Multicultural Women by Seramount (formerly Working Mother Media), an honor recognizing companies that create and use best practices in hiring, retaining and promoting multicultural women in the United States.
Upcoming webcasted investor events

Morgan Stanley 19th Annual Global Healthcare Conference at 8:00 a.m. Eastern, September 14, 2021
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss fourth-quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until August 5, 2022.

On August 5, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Jounce Therapeutics, AUG 5, 2021, View Source [SID1234585899]).

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"I am very pleased with the progress Jounce has made this quarter as we continued to advance our two proof of concept studies, INNATE and SELECT, achieved IND clearance on our fourth internally discovered program and expanded our discovery programs to include additional LILRB family members. Our team has made important and rapid progress in our INNATE study with the announcement today of monotherapy dose escalation enrollment completion and target dose selection. We look forward to beginning the next stages of the trial in third quarter of this year," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We remain steadfast in our commitment to discover and develop novel IO therapies to meet the growing unmet medical need experienced in cancer patients, particularly in the area of PD-(L)1 inhibitor resistance. We believe our focus on translational science, biomarker approaches, and targeting new immune mechanisms leads us closer to bringing the right immunotherapies to the right patients."

Pipeline Update:

JTX-8064 (LILRB2 / ILT4)

Completed enrollment in monotherapy dose escalation portion of INNATE: Jounce announces today that the monotherapy dose escalation portion of the Phase 1 trial of JTX-8064 is complete. The monotherapy dose escalation included seven doses ranging from 50 mg to the highest planned dose of 1200 mg. To date, JTX-8064 has been well-tolerated with no dose limiting toxicities.
Identified target dose for next stages of INNATE: Jounce announces today the selection of its target dose of 700 mg. The selected target dose was based on a combination of safety, pharmacokinetic, and receptor occupancy data in the first three-week cycle. During the third quarter of 2021, Jounce expects to open eight expansion cohorts for enrollment, one with JTX-8064 monotherapy at its target dose and seven with JTX-8064 in combination with pimivalimab.
Presented trial in progress posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting: In June 2021, Jounce presented a trial in progress poster at the ASCO (Free ASCO Whitepaper) Annual Meeting on INNATE. The poster included the study design and the rationale for indications chosen for the expansion cohorts.
Vopratelimab (ICOS) and Pimivalimab (PD-1)

Continued enrollment in Phase 2 SELECT trial of vopratelimab: Enrollment continues in SELECT, a randomized Phase 2 trial to evaluate vopratelimab in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer (NSCLC) patients. The SELECT trial also aims to provide additional important single agent data for pimivalimab in a new biomarker selection paradigm. Jounce is on track to report data from the SELECT trial in 2022.
Presented trial in progress poster at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting: In June 2021, Jounce presented a trial in progress poster at the ASCO (Free ASCO Whitepaper) Annual Meeting on SELECT. The poster described the study design, TISvopra biomarker, and patient selection strategy of the SELECT trial.
JTX-1811 (CCR8)

Clearance of IND triggering first milestone under Gilead license agreement: In June 2021, Jounce received clearance from the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for JTX-1811, a potential first-in-class antibody designed to bind to CCR8 and selectively deplete immunosuppressive tumor-infiltrating T regulatory cells. The IND clearance triggered a $25.0 million milestone payment to Jounce which was received in July 2021. Gilead now has sole rights to develop and commercialize the JTX-1811 program, which will be referred to as GS-1811 in their pipeline.
Discovery Pipeline

Announced new discovery program targets: Jounce continues to invest in and advance its growing immuno-oncology pipeline. The broad discovery pipeline includes multiple programs targeting diverse immune cell types and PD-(L)1 inhibitor resistance mechanisms. Jounce is rapidly advancing two additional LILRB family programs through discovery, one targeting LILRB1 and the other targeting LILRB4. With the goal of submitting a new IND every 12 to 18 months, Jounce expects at least one of its next development candidates to target the LILRB family of receptors.
Second Quarter 2021 Financial Results:

Cash position: As of June 30, 2021, cash, cash equivalents and investments were $246.1 million, compared to $213.2 million as of December 31, 2020. The increase was primarily due to receipt of $90.9 million in net proceeds from the follow-on public offering and sales under Jounce’s at-the-market offering program completed during the period, offset by operating expenses incurred. This amount excludes the $25.0 million milestone Jounce received from Gilead in July 2021.
License and collaboration revenue: Jounce recognized $25.4 million of license and collaboration revenue during the second quarter of 2021. License and collaboration revenue recognized during the period was related to milestone achievement and research and transition services performed under the license agreement with Gilead. No revenue was recognized for the same period in 2020.
Research and development expenses: Research and development expenses were $22.1 million for the second quarter of 2021, compared to $21.0 million for the same period in 2020. The increase in research and development expenses was primarily due to increased manufacturing activities performed for Jounce’s development programs and increased clinical and regulatory spend on JTX-8064 offset by decreased spend on vopratelimab.
General and administrative expenses: General and administrative expenses were $7.3 million for the second quarter of 2021, compared to $7.2 million for the same period in 2020. The increase in general and administrative expenses was primarily due to increased insurance expense.
Net loss: Net loss was $4.0 million for the second quarter of 2021, resulting in basic and diluted net loss per share of $0.08. Net loss was $28.0 million for the same period in 2020, resulting in a basic and diluted net loss per share of $0.82. The decrease in net loss and net loss per share was attributable to revenue recognized in the second quarter of 2021.
Financial Guidance:

Based on its current operating and development plans, Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2021 to be approximately $95.0 million to $110.0 million.

Given the strength of its balance sheet, Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements through the third quarter of 2023.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4291658. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

On August 5, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2021 and provided a business update (Press release, Regeneron, AUG 5, 2021, View Source [SID1234585898]).

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"Regeneron had outstanding performance in the second quarter during which we delivered to the U.S. government the entire order for our COVID-19 antibody cocktail and recognized record global sales from our EYLEA and Dupixent franchises," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We continue to advance Dupixent’s potential to help new patient groups, with recent positive Phase 3 data in chronic spontaneous urticaria and additional late-stage read-outs expected later this year in prurigo nodularis, eosinophilic esophagitis, and pediatric atopic dermatitis. With today’s positive Phase 3 results in combination with chemotherapy in non-small cell lung cancer, Libtayo yet again demonstrates its potential to be a leading checkpoint inhibitor. We also progressed our genetics medicines platform, with landmark clinical data alongside our collaborator Intellia using a CRISPR therapeutic and the discovery of a promising new obesity target from the Regeneron Genetics Center."

"Regeneron performed exceptionally well in the second quarter with the core business on a strong growth trajectory as we invest in our diverse and differentiated pipeline for long-term and sustainable growth," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron.

Business Highlights

Key Pipeline Progress

Regeneron has approximately 30 product candidates in clinical development, including six marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

EYLEA (aflibercept) Injection

Enrollment in the Phase 3 studies for high-dose formulation in diabetic macular edema (DME) and neovascular age-related macular degeneration (wet AMD) was completed.
Enrollment in the Phase 3 study for retinopathy of prematurity (ROP) was also completed.
Dupixent (dupilumab)

The Company and Sanofi announced a Phase 3 trial in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints at 24 weeks. The trial showed that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naive patients, compared to antihistamines alone in the first of two trials of this clinical program.
In June 2021, the U.S. Food and Drug Administration (FDA) approved a 200 mg single-dose pre-filled pen for Dupixent.
REGEN-COVTM (casirivimab and imdevimab)(2), a dual antibody cocktail to SARS-CoV-2 virus

In the second quarter of 2021, the Company fulfilled its second agreement with the U.S. government to manufacture and deliver 1.25 million doses of REGEN-COV at the lowest treatment dose authorized by the FDA, and recognized $2.59 billion of REGEN-COV sales.
In June 2021, the FDA updated the REGEN-COV EUA by lowering the dose to 1,200 mg and permitting administration by subcutaneous injection when intravenous infusion is not feasible.
In July 2021, based on positive Phase 3 data announced in April 2021 which were recently published in the New England Journal of Medicine, the FDA also expanded the EUA to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and who have been exposed to a SARS-CoV-2 infected individual or are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons). For people who are not expected to mount an adequate immune response to vaccination, REGEN-COV can also now be administered monthly for the duration of ongoing exposure to SARS-CoV-2.
In July 2021, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved the casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19, making Japan the first country to grant a full approval for the antibody cocktail.
Positive results were announced from the Phase 3 UK-based RECOVERY trial in hospitalized COVID-19 patients, demonstrating that adding REGEN-COV to usual care reduced the risk of death by 20% in seronegative patients (patients who had not mounted a natural antibody response on their own against SARS-CoV-2), compared to seronegative patients receiving usual care alone. The Company has requested that the EUA be further expanded to include appropriate hospitalized patients.
Libtayo (cemiplimab)

In June 2021, the European Commission (EC) approved Libtayo for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).
In June 2021, the EC also approved Libtayo for the treatment of metastatic or locally advanced basal cell carcinoma (BCC).
In August 2021, the Company and Sanofi announced that the Phase 3 trial of Libtayo in combination with platinum-doublet chemotherapy was stopped early after meeting its overall survival primary endpoint in patients with advanced NSCLC. These data are planned to form the basis of regulatory submissions in the United States and European Union (EU).
Odronextamab, a CD20xCD3 bispecific antibody

The Company is resuming enrollment of patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), following amendment of trial protocols and the FDA’s lifting of the partial clinical hold, in its monotherapy trials of odronextamab.
Fianlimab, an antibody to LAG-3

Positive data from the Phase 1 trial in combination with Libtayo in advanced melanoma were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting; the Company intends to initiate a Phase 3 study in 2022.
REGN1908-1909, a multi-antibody therapy to Fel d 1

The Company initiated a Phase 3 study in cat allergic asthmatics.
Genetics Medicines

Intellia Therapeutics, Inc. and the Company announced positive interim data from the Phase 1 study of NTLA-2001, a CRISPR/Cas9 therapeutic for TTR gene knockout in people living with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). These are the first-ever clinical data supporting safety and efficacy of in vivo CRISPR genome editing in humans and provide proof of concept for the ongoing multi-target collaboration between the companies.
The Regeneron Genetics Center published their discovery of GPR75 gene mutations that protect against obesity. This target is the focus of a small molecule collaboration agreement with AstraZeneca announced in July 2021, under which the companies will equally share research and development costs and any potential future profits.
Corporate Updates

The Company intends to invest approximately $1.8 billion over six years to expand its research, preclinical manufacturing, and support facilities at the Company’s Tarrytown, New York campus.

Second Quarter 2021 Financial Results

Revenues

Total revenues increased by 163% to $5.139 billion in the second quarter of 2021, compared to $1.952 billion in the second quarter of 2020. Total revenues excluding (i) REGEN-COV (casirivimab and imdevimab) net product sales in the United States and (ii) the Company’s share of gross profits in connection with Roche’s sales of casirivimab and imdevimab outside the United States, increased by 22% to $2.379 billion in the second quarter of 2021, compared to the second quarter of 2020(1).

Net product sales of EYLEA in the United States increased in the second quarter of 2021, compared to the second quarter of 2020, primarily due to higher sales volume as well as a favorable comparison given the adverse impact of the COVID-19 pandemic on U.S. EYLEA demand during the second quarter of 2020.

The Company fulfilled its second agreement with the U.S. government and delivered 1.25 million doses of REGEN-COV. Other than $34 million of expected REGEN-COV net product sales in the third quarter of 2021 related to this agreement, the Company does not anticipate recording any additional net product sales of REGEN-COV in the United States during the third quarter of 2021. U.S. net product sales of REGEN-COV in the fourth quarter of 2021 will be dependent upon acceleration of COVID-19 cases and related drug utilization.

Total revenues also include collaboration revenues(3) of $955 million in the second quarter of 2021, compared to $513 million in the second quarter of 2020. Sanofi collaboration revenue increased primarily due to the Company’s share of profits from commercialization of antibodies, which were $328 million in the second quarter of 2021, compared to $172 million in the second quarter of 2020. The change in the Company’s share of profits from commercialization of antibodies was driven by higher Dupixent profits. In the second quarter of 2021, the Company also recorded Roche collaboration revenue of $168 million in connection with the Company’s share of gross profits from Roche’s sales of the casirivimab and imdevimab antibody cocktail outside the United States.

Refer to Table 4 for a summary of collaboration revenue.

Other revenue decreased in the second quarter of 2021, compared to the second quarter of 2020, primarily due to lower amounts recognized in connection with the Company’s agreements with the Biomedical Advanced Research Development Authority (BARDA) related to funding of certain development activities for antibodies for the treatment of COVID-19.

GAAP R&D expenses in the second quarter of 2020 included $85 million in up-front payments in connection with the collaboration agreement with Intellia. The decrease in GAAP R&D expenses in the second quarter of 2021 was offset primarily by higher costs incurred in connection with development activities related to REGEN-COV, which also drove the increase in non-GAAP R&D expenses.
The increase in GAAP and non-GAAP SG&A expenses in the second quarter of 2021 was primarily due to higher headcount-related costs, an increase in commercialization-related expenses for EYLEA and Libtayo, and costs associated with educational campaigns related to COVID-19.
The increase in COGS in the second quarter of 2021 was primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV in the United States. In addition, the Company recognized higher inventory write-offs and reserves in the second quarter of 2021, compared to the second quarter of 2020.
Other operating (income) expense, net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with the Company’s collaborative arrangements.
Other Financial Information

GAAP other income (expense), net, includes the recognition of net unrealized and realized gains on equity securities of $409 million in the second quarter of 2021, compared to $228 million in the second quarter of 2020.

In the second quarter of 2021, the Company’s GAAP effective tax rate was 17.4%, compared to 2.4% in the second quarter of 2020. The increase in the second quarter 2021 GAAP effective tax rate, compared to the second quarter of 2020, was primarily due to the significant positive impact of stock-based compensation in the second quarter of 2020. In the second quarter of 2021, the non-GAAP effective tax rate was 17.0%, compared to 0.9% in the second quarter of 2020.

GAAP net income per diluted share was $27.97 in the second quarter of 2021, compared to GAAP net income per diluted share of $7.61 in the second quarter of 2020. Non-GAAP net income per diluted share was $25.80 in the second quarter of 2021, compared to non-GAAP net income per diluted share of $7.16 in the second quarter of 2020. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

Net cash provided by operating activities in the first half of 2021 was $1.295 billion, compared to $1.641 billion in the first half of 2020, resulting in $1.031 billion in free cash flow for the first half of 2021, compared to $1.341 billion for the first half of 2020. The Company expects a significant increase in free cash flow in the third quarter of 2021 as the Company collected all amounts due from the U.S. government in connection with second quarter 2021 REGEN-COV sales in July 2021.

2021 Financial Guidance(4)

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its second quarter 2021 financial and operating results on Thursday, August 5, 2021, at 8:30 AM Eastern Time. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 9098036. A link to the webcast may be accessed from the "Investors and Media" page of Regeneron’s website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days.

On August 5, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported it will host a conference call to discuss the second quarter 2021 financial results and provide a corporate update on Thursday, August 12, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, AUG 5, 2021, View Source [SID1234585897]).

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Conference Call and Webcast:

Thursday, August 12, 2021 @ 4:30 p.m. Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID# 2398834
International: (973) 796-5077, Conference ID# 2398834

The conference call will also be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.