On August 4, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the second quarter ended June 30, 2021 (Press release, Zymeworks, AUG 4, 2021, View Source [SID1234585718]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second half of 2021 is an exciting time at Zymeworks as we prepare to present important data readouts at upcoming medical conferences in support of the planned launch of our pivotal trial for zanidatamab in first-line HER2-positive gastric cancer," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "The first data presentation will be at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting in September and highlights results from our Phase 2 clinical trial evaluating zanidatamab plus chemotherapy in first-line gastric cancer, a setting where the current standard of care is Herceptin plus chemotherapy. These results will be integral to our goal of establishing zanidatamab as the new foundational HER2-targeted therapy and bring us one step closer to realizing our mission of enabling patients to return home to their loved ones, disease free."

Second Quarter 2021 Business Highlights and Recent Developments

Zanidatamab in First-Line Gastroesophageal Adenocarcinoma (GEA) to be Presented at ESMO (Free ESMO Whitepaper) Annual Meeting
The presentation will feature new clinical data for our lead product candidate, zanidatamab, in combination with chemotherapy, as a first-line treatment for patients with HER2-positive GEA. The presentation will be available on Thursday, September 16 at 8:30 AM CEST (Central European Summer Time) on both the ESMO (Free ESMO Whitepaper) and Zymeworks websites.
Enrollment Initiated for First-Line Biliary Tract Cancer and Colorectal Cancer Cohorts in Zanidatamab Phase 2 Clinical Trial
The ongoing Phase 2 study is evaluating zanidatamab in combination with standard of care chemotherapy as a first-line treatment for patients with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastrointestinal cancers including biliary tract cancer, colorectal cancer, and GEA. Results from this study are expected to inform future potential pivotal trials.
First Patient Dosed with Zanidatamab in Combination with Tukysa (Tucatinib) and Chemotherapy in Advanced HER2-Positive Breast Cancer
The first patient has been dosed in a new cohort of a Phase 1 trial investigating the safety, tolerability, and efficacy of zanidatamab in combination with tucatinib and capecitabine. This new cohort will evaluate HER2-positive breast cancer patients with locally advanced (unresectable) and/or metastatic disease that have received prior therapy with trastuzumab, pertuzumab and T-DM1.
First Patient Dosed for Janssen-Developed Bispecific Antibody Utilizing Zymeworks’ Azymetric and EFECT Therapeutic Platforms
The new bispecific antibody developed by Janssen, JNJ-78278343, represents Zymeworks’ fourth pharmaceutical partnership with programs reaching clinical development. Zymeworks will receive a payment in connection with this milestone under Zymeworks’ 2017 licensing agreement with Janssen.
ZW49 Cohort Expansion Study Opens New Sites in South Korea and Australia
Zymeworks has opened new sites in South Korea and Australia to accelerate the cohort expansion portion of the Phase 1 clinical trial for ZW49. This will support Zymeworks’ goal of identifying the recommended Phase 2 dose and schedule by the end of this year. Dose escalation continues in weekly and once every three week schedules while three indication-specific expansion cohorts utilizing the 2.5 mg/kg once every three week regimen are ongoing.
Financial Results for the Quarter Ended June 30, 2021

Zymeworks’ revenue relates primarily to non-recurring upfront fees, expansion payments or milestone payments from collaboration and license agreements, which can vary in timing and amount from period to period, as well as research support and other payments. Revenue for the three months ended June 30, 2021 was $1.8 million compared to $12.4 million for the same period of 2020. Revenue for the second quarter of 2021 related to research support and other payments from our partners. Revenue for the same period in 2020 included recognition of a $12.0 million expansion fee resulting from an amendment to our collaboration agreement with BMS, as well as $0.4 million in research support and other payments from our partners.

For the three months ended June 30, 2021, research and development expenses were $50.7 million compared to $39.8 million for the same period of 2020. The increase was primarily due to higher salaries and benefits expense from additional headcount as well as higher stock-based compensation expense and third-party research and development program expenses. For the three months ended June 30, 2021, research and development expenses included non-cash stock-based compensation expense of $5.8 million from equity-classified equity awards and $0.2 million from the non-cash mark-to-market revaluation of certain historical liability classified equity awards. Excluding stock-based compensation expense, research and development expenses increased by $8.1 million for the three months ended June 30, 2021 compared to the same period in 2020.

For the three months ended June 30, 2021, general and administrative expenses were $19.9 million compared to $12.9 million for the same period in 2020. The increase was primarily due to higher salaries and benefits due to additional headcount, stock-based compensation expense and professional fees. For the three months ended June 30, 2021, general and administrative expenses included non-cash stock-based compensation expense of $5.3 million from equity-classified equity awards and $1.5 million from the non-cash mark-to-market revaluation of certain historical liability-classified equity awards. Excluding stock-based compensation expense, general and administrative expenses increased by $3.9 million for the three months ended June 30, 2021 compared to the same period in 2020.

Net loss for the three months ended June 30, 2021 was $67.5 million compared to $39.0 million for the same period of 2020. This was primarily due to the decrease in revenue and interest income and increase in research and development and general and administrative expenses referred to above.

Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of the Company’s clinical development of its product candidates, as well as its ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of June 30, 2021, Zymeworks had $359.8 million in cash resources consisting of cash, cash equivalents and short-term investments. We anticipate this will enable us to fund our planned operations into the second half of 2022 and potentially beyond.

On August 4, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed retiring Founding CEO Rachel King (Press release, GlycoMimetics, AUG 4, 2021, View Source [SID1234585717]). Mr. Semerjian, a seasoned executive with strong oncology commercialization experience, will lead the company as it advances its registrational trials on its lead clinical candidate, uproleselan, in acute myeloid leukemia (AML), accelerates planning for potential commercialization, and continues to build out the company’s pipeline.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Tim Pearson, Chairman of the Board of Directors of GlycoMimetics, said, "On behalf of the entire Board, I offer sincere thanks to Rachel for her leadership of GlycoMimetics and for her commitment to the company’s employees and to patients who will hopefully benefit from GlycoMimetics’ technology. We look forward to her continued contributions as a board member."

Mr. Pearson continued, "Harout is ideally positioned to lead GlycoMimetics into the company’s next phase of growth as we anticipate the completion of our Phase 3 trial and potential commercialization of uproleselan. He possesses the right leadership and operational skills as well as tremendous know-how from his many years at Novartis overseeing several oncology and hematology product launches and from subsequent C-level positions he has held within the industry. I am confident Harout will be an effective leader for GlycoMimetics into the future."

Mrs. King, who has served as CEO for 18 years, has decided to retire for personal reasons and will continue her involvement with the company through her role on the Board of Directors and serving as an advisor during this transition. Mrs. King led GlycoMimetics’ evolution from an early venture-backed company through its initial public offering, strategic partnerships and the advancement of two late-stage clinical candidates. She also shepherded the company’s unique and productive glycochemistry platform to build a multi-faceted pipeline of drug candidates targeting key unmet needs in oncology, sickle cell disease and other indications.

"It has been a privilege and a pleasure to lead GlycoMimetics and to work with such an extraordinary team of colleagues," said Mrs. King. "I am extremely proud of what we have collectively accomplished in the 18 years since the company was founded. When I approached the Board to let them know that I was considering retirement, I committed to do all I can to ensure a smooth transition. I look forward to working with Harout and the team as a board member to continue to advance our programs. My decision to focus on spending more time with my family seems appropriately timed as we near an opportunity to commercialize our first product candidate."

Mr. Semerjian is a global biopharmaceutical veteran. Over the last 25 years, he acquired extensive US, European and international commercialization experience having led multiple successful hematology/oncology product launches, including preparation for the launch of midostaurin in AML. During his 16-year tenure at Novartis, Mr. Semerjian held both strategic and operational leadership roles including US Hematology franchise head. He then served as EVP, chief commercial officer at Ipsen where he was accountable for worldwide commercialization and portfolio strategy. Most recently, he briefly served as CEO of Immunomedics before its sale to Gilead Sciences, Inc.

"I believe GlycoMimetics has exciting opportunities ahead. Uproleselan is a differentiated drug candidate already recognized by both FDA and the Chinese regulatory authority with Breakthrough Therapy Designations and the potential for significant impact across the spectrum of AML. The enthusiasm of independent investigators as well as the clinicians participating in our registration trials provides a foundation for a successful commercialization plan, should the readout and regulatory interactions prove positive. While there are just a few glycobiology-based therapeutics on the market today, the field of glycobiology is rapidly advancing and ripe with opportunity. The expertise resident in GlycoMimetics underlies my confidence in its platform’s productivity. Across the pipeline, I’m seeing novel and potentially game-changing therapies," said Mr. Semerjian. "I look forward to working with the outstanding team at GlycoMimetics as we strive to make a difference in the lives of patients with cancer and other diseases."

On August 4, 2021 McKesson Corporation (NYSE:MCK) reported results for the first quarter ended June 30, 2021 (Press release, McKesson, AUG 4, 2021, View Source [SID1234585716]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fiscal 2022 First-Quarter Result Summary

"McKesson delivered record first-quarter earnings, marking another quarter of solid performance across all four operating segments," said Brian Tyler, chief executive officer. "As we execute against our strategic priorities, we are evolving our portfolio to drive long-term growth and create shareholder value. We remain optimistic that the momentum we’ve generated will continue given the strength we see across our businesses. Based on our first-quarter operating performance and current trends, we are raising our previous guidance range for fiscal 2022 Adjusted Earnings per diluted share to $19.80 to $20.40."

First-quarter revenues were $62.7 billion, an increase of 13% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to higher volumes from retail national account customers and market growth, partially offset by branded to generic conversions.

During the first quarter of fiscal 2022, McKesson committed to donate certain personal protective equipment (PPE) to charitable organizations to assist in COVID-19 recovery efforts. First-quarter earnings per diluted share from continuing operations of $3.09 included $164 million of pre-tax inventory charges on certain PPE and related products. First-quarter Adjusted Earnings per diluted share excluded $155 million of these charges for inventory which the company no longer intends to sell and will instead direct to charitable organizations.

First-quarter Adjusted Earnings per diluted share was $5.56 compared to $2.77 a year ago, an increase of 101%, driven by the recovery of prescription volumes and primary care patient visits following the onset of the COVID-19 pandemic. Adjusted Earnings per diluted share growth was also driven by a lower tax rate and the contribution from COVID-19 vaccine distribution and kitting programs with the U.S. government.

For the first three months of the fiscal year, McKesson returned $1.1 billion of cash to shareholders, which included $1.0 billion of common stock repurchases and $69 million of dividend payments. During the first three months of the fiscal year, McKesson used cash from operations of $1.6 billion, and invested $159 million in capital expenditures, resulting in negative Free Cash Flow of $1.8 billion. McKesson also used $1.0 billion of cash for payments related to the exercises of a put right option available to non-controlling shareholders of McKesson Europe that expired in June 2021.

Business Highlights

McKesson is playing a central role in the COVID-19 response efforts in the U.S. and abroad through the distribution of COVID-19 vaccines, ancillary supply kits, and COVID-19 tests.
McKesson’s partnership with the U.S. government was expanded to support the U.S. government’s international COVID-19 vaccine donation mission. Including vaccine distribution in the U.S. and related to the U.S. government’s international donation mission, McKesson has successfully shipped over 250 million COVID-19 vaccines on behalf of the U.S. government through July 31, 2021.
On July 7, 2021, McKesson announced that it has entered into an agreement to sell its European businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX group for approximately $1.5 billion, subject to certain adjustments under the agreement. The transaction is subject to customary closing conditions, including regulatory review, and is expected to close in fiscal 2023. McKesson is committed to exploring strategic alternatives for all remaining European businesses.
U.S. Pharmaceutical Segment

First-quarter revenues were $50.0 billion, an increase of 12%, driven by higher volumes from retail national account customers and market growth, partially offset by branded to generic conversions.
First-quarter Segment Operating Profit was $682 million. Adjusted Segment Operating Profit was $682 million, an increase of 16%, driven by the contribution from COVID-19 vaccine distribution and growth in distribution of specialty products to providers and health systems.
Prescription Technology Solutions Segment

First-quarter revenues were $881 million, an increase of 34%, driven by higher volumes of technology and service offerings to support biopharma customers and the recovery of prescription volumes.
First-quarter Segment Operating Profit was $104 million. Adjusted Segment Operating Profit was $139 million, an increase of 62%, driven by organic growth from access and adherence solutions and the recovery of prescription volumes.
Medical-Surgical Solutions Segment

First-quarter revenues were $2.5 billion, an increase of 40%, driven by improvements in primary care patient visits and increased sales of COVID-19 tests.
First-quarter Segment Operating Profit was $75 million and included $164 million of pre-tax inventory charges on certain PPE and related products. During the first quarter of fiscal 2022, McKesson committed to donate certain PPE to charitable organizations to assist in COVID-19 recovery efforts. First-quarter Adjusted Segment Operating Profit excluded $155 million of these charges for inventory which the company no longer intends to sell and will instead direct to charitable organizations.
Adjusted Segment Operating Profit was $257 million, an increase of 107%, driven by improvements in primary care patient visits and the contribution from kitting and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
International Segment

First-quarter revenues were $9.2 billion. On an FX-Adjusted basis, revenues were $8.3 billion, a decline of 3%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance which was completed during the third quarter of fiscal 2021, partially offset by volume recovery in the pharmaceutical distribution and retail pharmacy businesses.
First-quarter Segment Operating Profit was $53 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $151 million, an increase of 107%, driven by volume recovery in the pharmaceutical distribution and retail pharmacy businesses and distribution of COVID-19 tests and vaccines.
Company Updates

On July 21, 2021, McKesson announced that it 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.
McKesson’s Board of Directors declared an increase in the regular quarterly dividend to $0.47 per share of common stock, demonstrating McKesson’s commitment to returning cash to shareholders and confidence in its outlook.
For the sixth consecutive year, McKesson was named a "Best Place to Work for Disability Inclusion." McKesson earned a top-ranking score of 100 on the 2021 Disability Equality Index, a joint initiative of the American Association of People with Disabilities and Disabilities:IN.
Fiscal 2022 Outlook

McKesson raised fiscal 2022 Adjusted Earnings per diluted share guidance to $19.80 to $20.40 from the previous range of $18.85 to $19.45 to reflect strong first-quarter operating performance and increased contribution from the U.S. government’s COVID-19 vaccine distribution and kitting programs. Fiscal 2022 Adjusted Earnings per diluted share guidance assumes $0.45 to $0.55 related to U.S. government COVID-19 vaccine distribution and does not assume any contribution from COVID-19 vaccines designated for pediatric patients or booster shots. Guidance also assumes $0.35 to $0.45 related to the kitting and distribution of ancillary supplies. Additional modeling considerations will be provided in the earnings call presentation.

Conference Call Details

The company has scheduled a conference call for today, Wednesday, August 4th at 4:30 PM ET to discuss the company’s financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

Morgan Stanley 19th Annual Healthcare Conference, September 13, 2021
Audio webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community, including details and updates, will be available on the company’s Investor Relations website.

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

On August 4, 2021 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) ("Protagonist" or "the Company") reported its financial results for the second quarter ended June 30, 2021, and an overview of recent company progress (Press release, Protagonist, AUG 4, 2021, View Source [SID1234585715]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter of 2021 was one of enormous progress, achievement, and growth for our Company," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer. "In April, we announced completion of enrollment for our Phase 2 study of rusfertide in polycythemia vera, data from which supported the U.S. Food and Drug Administration’s Breakthrough Therapy Designation. In mid-June, we shared updated results from this Phase 2 study in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper)’s 2021 Virtual Congress. This data, from 63 patients, continues to demonstrate rusfertide’s potential as the first-in-class, non-cytoreductive treatment option for this disease. The durability of effect and symptom improvements observed provided further support for the advancement of rusfertide into Phase 3 clinical development, expected to commence in early 2022."

Dr. Patel continued, "Looking ahead to the remainder of this year and into early 2022, Protagonist has multiple catalysts in view and underway. We intend to announce a third indication for rusfertide, beyond polycythemia vera and hereditary hemochromatosis. We look forward to sharing, for the first time, data from our clinical proof-of-concept study of rusfertide in hereditary hemochromatosis. In the fourth quarter, we are excited to share data from the completed Phase 2 study of rusfertide in polycythemia vera, meanwhile preparing diligently for the Phase 3 study. Finally, we remain intensely engaged in the successful execution of our Phase 2 study of PN-943 in ulcerative colitis and intend to share data from this study in the second quarter of 2022."

Second Quarter 2021 Recent Developments and Upcoming Milestones

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

Completed enrollment in the Phase 2 study of rusfertide in PV.
Reported updated results from the Phase 2 study of rusfertide in PV at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress, which was selected for an oral presentation. The Company expects to report further updated data in PV by the end of 2021.
Secured Breakthrough Therapy Designation from the FDA for rusfertide in PV.
Plan to announce third indication beyond PV and hereditary hemochromatosis (HH) by the end of 2021.
Intend to report preliminary data from Phase 2 proof-of-concept study in HH by the end of 2021.
On track to commence Phase 3 study of rusfertide in PV in early 2022.
PN-943: Oral, gut-restricted, alpha-4-Beta-7 Integrin Antagonist for Ulcerative Colitis

Announced significant progress in the enrollment and execution of the Phase 2 study of PN-943 in ulcerative colitis, revising guidance in anticipation of a sooner-than-expected data readout of the completed study. The Company expects to report results of the completed study in the second quarter of 2022.
Oral IL-23 Receptor Antagonists (Janssen Biotech and Protagonist Collaboration)

As disclosed in July 2021, the oral IL-23 receptor antagonists collaboration between Janssen Biotech and Protagonist has advanced and expanded through an amendment to the original agreement.
The amended agreement provides for Janssen to lead worldwide development, manufacturing, and commercialization, and also broadens the range of indications contemplated for these drug candidates. Protagonist’s development and expense obligations are now limited to the ongoing PTG-200 Phase 2a study in Crohn’s disease and to the ongoing Phase 1 studies investigation PN-232 and PN-235.
Under the amended agreement, Protagonist remains eligible for approximately $900M in future milestone payments, in addition to the $80M in payments already received under the original agreement.
The Phase 1 study of PN-235, the first of the second-generation oral IL-23 receptor antagonists included in the Janssen collaboration, is in progress, with study completion expected in the fourth quarter of 2021.
Announced the dosing of the first human subject in a Phase 1 study of PN-232, the second of the second-generation oral IL-23 receptor antagonist peptides included in the collaboration with Janssen.
Second Quarter 2021 Financial Results

Financial Update

In the second quarter of 2021, Protagonist announced the commencement and closing of an underwritten public offering of 3,503,311 shares of its common stock, including 456,953 shares sold pursuant to the underwriters’ option to purchase additional shares, at a price to the public of $37.75 per share. Aggregate gross proceeds to Protagonist from the offering were approximately $132.2 million, before deducting underwriting discounts and commissions and offering expenses.
Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2021 were $380.4 million. The company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through 2024.
License and Collaboration Revenue: License and collaboration revenues were $2.3 million and $8.5 million for the three and six months ended June 30, 2021, respectively, in comparison to $6.2 million and $9.9 million reported for the same periods of 2020. The revenue was lower in the second quarter and year to date 2021 compared to the prior year due primarily to the Company delivering a lower amount of collaboration related services during 2021 when compared to 2020. This follows as the Company in 2021 is now nearing completion of its remaining service obligations being provided under the collaboration. In particular, we are near the end of both the ongoing phase 1 trials in PN-235 & PN-232, which are expected to be completed in the fourth quarter of 2021 and early 2022, respectively.
Research and Development ("R&D") Expenses: R&D expenses for the three and six months ended June 30, 2021 were $26.4 million and $50.7 million, respectively, as compared to $20.3 million and $39.0 million, respectively, for the same periods of 2020. The increases were primarily due to additional costs associated to advancing our clinical trials with our pipeline assets rusfertide and PN-943, as well as our second-generation IL-23 receptor antagonist assets under the Janssen collaboration (PN-235 and PN-232). The increases also relate to higher research spending and employee related costs, including stock-based compensation expenses following recent hiring in support of our advancing research and development programs.
General and Administrative ("G&A") Expenses: G&A expenses for the three and six months ended June 30, 2021 were $6.7 million and $12.7 million, respectively, as compared to $4.2 million and $8.8 million for the same periods of 2020. The increases were primarily related to professional fees, insurance costs and employee compensation related expenses, including stock-based compensation expenses, supporting the growth in our operations.
Net Loss: The second quarter 2021 net loss was $30.8 million, or a net loss of $0.69 per share, and the six months ended June 30, 2021 net loss was $54.8 million, or a net loss of $1.23 per share, compared to the second quarter of 2020 net loss of $19.4 million, or a net loss of $0.59 per share, and the six months ended June 30, 2020 net loss of $39.5 million, or a net loss of $1.31 per share.

On August 4, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the second quarter of 2021, and associated Company developments (Press release, Supernus, AUG 4, 2021, View Source [SID1234585714]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The approval and commercial launch of Qelbree for pediatric patients with ADHD mark an important milestone for children and families searching for new treatment options for ADHD," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "As a non-controlled substance that has a unique profile of proven efficacy, safety and tolerability, Qelbree provides patients living with ADHD a novel treatment option like no other ADHD medication."

Net Product Sales

Second quarter 2021 net product sales were $138.6 million, 12% higher than the same period in 2020.

(1) Net product sales of APOKYN, MYOBLOC and XADAGO from June 9, 2020 to June 30, 2020.

Qelbree Launch Update

At the end of May 2021, Supernus launched Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. Net product sales for the second quarter of 2021 were $0.3 million.
The early performance of Qelbree is on track with our expectations. Current trends in prescriptions reflect the heavy sampling programs with patients. Over 25,000 starter kits have been distributed to physicians since the launch and in preparation for the back-to-school season.
Early clinical feedback about the performance of Qelbree in patients is positive and in line with the Phase III clinical results.
Product Pipeline Update

Qelbree (viloxazine, extended-release capsules) – Novel non-stimulant for the treatment of ADHD in adults

The Company recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Qelbree for adult patients with ADHD.
SPN-830 (apomorphine infusion pump) – Continuous treatment of motor fluctuations ("on-off" episodes) in Parkinson’s disease (PD)

The Company continues to plan to resubmit the SPN-830 NDA in the second half of 2021.
SPN-820 – Novel first-in-class activator of mTORC1

A randomized Phase II clinical study of SPN-820 in treatment-resistant depression is expected to start by the end of 2021.
Financial Highlights

Second quarter 2021 operating earnings were $34.1 million, as compared to $45.5 million in the second quarter of 2020. Operating earnings for the second quarter of 2021 included amortization of intangible assets expense of $5.9 million, compared to $2.4 million in the second quarter of 2020.

Second quarter 2021 net earnings and diluted earnings per share were $23.7 million and $0.43, respectively, as compared to $34.7 million, or $0.65 per diluted share, in the same period last year.

As of June 30, 2021, the Company had $855.3 million in cash, cash equivalents, current and long-term marketable securities, compared to $772.9 million as of December 31, 2020.

Full Year 2021 Financial Guidance

For full year 2021, the Company reiterates its prior financial guidance including an increase to the lower end of its operating earnings guidance as set forth below:

(1) Total revenues include net product sales and royalty revenue. Includes $10 million for Qelbree net product sales.
(2) Combined research and development and selling, general and administrative expenses.
(3) Operating earnings include amortization of intangible assets and contingent consideration expense (gain). Reflects an increase from the original guidance of $65 – $90 million.
(4) The full year 2021 effective tax rate guidance of 28% – 31% is above the normally expected range of 26% – 28% due to the effect of discrete tax items in the period.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer and Jim Kelly, Executive Vice President and Chief Financial Officer, to discuss these results at 4:30 p.m. Eastern Time, today, August 4, 2021.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Following the live call, a replay will be available on the Company’s website, www.supernus.com, under "Investor Relations".