On May 6, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a corporate and financial update for the first quarter ended March 31, 2021 (Press release, Athenex, MAY 6, 2021, View Source [SID1234579376]).

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"We continue to work diligently with our advisers to analyze and respond to the complete response letter received from the FDA on oral paclitaxel plus encequidar (oral paclitaxel). We are collecting additional data and doing additional analyses in support of our application. We expect to have a type A meeting with the FDA before end of the second quarter." said Johnson Lau, CEO and Chairman of Athenex. "We remain committed to pursuing regulatory approval of oral paclitaxel and aim to bring this important product to market to benefit metastatic breast cancer patients. We hope to align with the FDA, work to resolve its concerns and reach agreement on the path forward required to obtain approval. In parallel, we continue our efforts to deepen our pipeline and are excited to add Kuur Therapeutics and its innovative allogeneic CAR-NKT technology to the Athenex platform."

First Quarter 2021 and Recent Business Highlights

Clinical Programs

Oral Paclitaxel for Metastatic Breast Cancer

Athenex received a Complete Response Letter (CRL) from the US Food & Drug Administration (FDA) for the New Drug Application (NDA) for oral paclitaxel in metastatic breast cancer on February 26, 2021.
Klisyri in actinic keratosis

Almirall, S.A. (BLM: ALM), Athenex’s U.S. partner, launched Klisyri in the U.S. on February 18, 2021, triggering a $20 million milestone payment from Almirall
In February 2021, the New England Journal of Medicine published Phase 3 trial results on the efficacy and safety of tirbanibulin ointment for the topical treatment of actinic keratosis of the face or scalp
Cell Therapy

Acquired Kuur Therapeutics (privately held), a leading developer of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies in May 2021
Athenex will pay $70 million upfront, comprised primarily of equity in Athenex common stock, to Kuur shareholders and certain of its former employees and directors
Additionally, Kuur shareholders and certain of its former employees and directors are eligible to receive up to $115 million of milestone payments, which Athenex may elect to pay in cash, additional Athenex common stock, or a combination of both
Acquisition provides an allogeneic NKT platform that can be applied to our high affinity TCR in solid tumors
High-affinity TCR-T in NY-ESO-1 to enter the clinic in a Phase 1 trial at Baylor in 1H 2021
Commercial Business

Product sales growth in the first quarter was primarily attributable to an increase in sales of 503B products
Athenex Pharmaceutical Division (APD) currently markets a total of 34 products with 61 SKUs
Athenex Pharma Solutions (APS) currently markets 6 products with 19 SKUs
Key Anticipated 2021 Milestones

Request a meeting with the FDA to discuss and align on next steps to obtain approval for oral paclitaxel in metastatic breast cancer
Begin expansion portion of the oral paclitaxel plus pembrolizumab Phase I trial into lung cancer and gastric cancer
Present oral paclitaxel plus pembrolizumab Phase I trial data at a medical conference
EMA approval of Klisyri in 2021
Present abstract on oral docetaxel in metastatic prostate cancer at ASCO (Free ASCO Whitepaper) 2021
Present abstract on oral paclitaxel plus encequidar in metastatic breast cancer at ASCO (Free ASCO Whitepaper) 2021
Expect TCR-T NY-ESO-1 IRB approval and to initiate Phase 1 trial enrollment in 1H 2021
Additional GINAKIT2 Phase I data to be presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th Annual Meeting on May 14, 2021
Results from the I-SPY 2 trial of oral paclitaxel plus anti PD-1 expected in 2022
Clinical Data Presentations

American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2021

Natural Killer T Cells Expressing a GD2- CAR and IL-15 Are Safe and Can Induce Complete Remission in Children with Relapsed Neuroblastoma – A First-in-Human, Phase I Trial
Dr. Andrus Heczey is the principal investigator. The abstract and work were selected for presentation at this year’s Clinical Trials Spotlight Symposium at ASGCT (Free ASGCT Whitepaper) on May 14, 2021, at 11 am ET
American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021

An open-label, pharmacokinetic study to determine the bioavailability, safety and tolerability of single dose oral docetaxel (Oradoxel) in metastatic prostate cancer (mPC) patients treated with IV docetaxel
Dr. Christopher Jackson is the primary author of the abstract, #5050, to be presented during the Genitourinary Cancer – Prostate, Testicular, and Penile, poster session
Confirmed tumor response by molecular subtype in patients with metastatic breast cancer: Sub-analysis from a phase 3 clinical study comparing oral paclitaxel and encequidar to IV paclitaxel
Dr. Gerardo Umanzor is the primary author of the abstract, #1073, to be presented during the Breast Cancer – Metastatic, poster session
An open-label, fixed-sequence study to evaluate the effect of encequidar (HM30181) an oral P-gp inhibitor, on the pharmacokinetics of dabigatran etexilate (a P-gp substrate) in healthy male volunteers
Dr. Christopher Jackson is the primary author of the abstract, #E15060, an online publication
The virtual scientific program of the ASCO (Free ASCO Whitepaper) will be held June 4-8, 2021
First Quarter 2021 Financial Highlights

Revenue from product sales increased to $20.4 million for the three months ended March 31, 2021, from $18.5 million for the three months ended March 31, 2020, an increase of $1.8 million or 10%. This increase was primarily attributable to an increase of $2.8 million in sales of 503B products. API product sales increased by $0.8 million, and contract manufacturing revenue from supply of Klisyri, to our partner Almirall, increased by $0.4 million due to the launch of the drug in February 2021. These increases were partially offset by a decrease of $2.3 million in APD sales.

License fees and other revenue decreased by $7.7 million, or 27%. For the three months ended March 31, 2021, we recorded $20.0 million of license revenue pursuant to the 2017 Almirall License Agreement upon the launch of Klisyri in the U.S., and $0.5 million related to the upfront fee pursuant to the Second Amendment to the 2011 PharmaEssentia License Agreement. For the three months ended March 31, 2020, we recognized $28.3 million in license revenue, net of $1.7 million value added tax ("VAT"), pursuant to the 2019 Xiangxue License Agreement.

Cost of sales for the three months ended March 31, 2021 totaled $16.4 million, a decrease of $3.2 million, or 16%, as compared to $19.6 million for the three months ended March 31, 2020. The decrease was primarily due to the royalty payment to Hanmi incurred in 2020 on the license revenue from Xiangxue. The decrease in cost of specialty product sales was in-line with the decrease in revenue.

R&D expenses for the three months ended March 31, 2021 totaled $23.1 million, an increase of $5.9 million, or 34%, as compared to $17.2 million for the three months ended March 31, 2020. This was primarily due to an increase in pre-launch product development costs, particularly in the first two months of 2021 prior to the receipt of the CRL, preclinical operations costs, drug licensing costs in relation to our specialty drug product in-licenses, and R&D related compensation expenses. The increase in these R&D expenses was partially offset by a decrease in clinical studies and patient costs on oral paclitaxel after completion of the Phase 3 studies and regulatory, API development, and 503B development costs.

SG&A expenses for the three months ended March 31, 2021, totaled $22.1 million, a decrease of $3.6 million, or 14%, as compared to $25.7 million for the three months ended March 31, 2020. This was primarily due to a decrease of $4.4 million related to the costs of preparing to commercialize oral paclitaxel as significant pre-launch activities occurred in 2020, and slowed upon receipt of the CRL in 2021. This was partially offset by an increase of $0.7 million of general and administrative costs related to increased hiring, professional fees, IT costs, and other operational costs.

Interest expense totaled $4.9 million and $1.7 million for the three months ended March 31, 2021, and 2020, respectively. Interest expense in the current period was incurred from the Senior Credit Agreement with Oaktree, while interest expense in the prior period was incurred from the debt with Perceptive.

Income tax expense for the three months ended March 31, 2021, was $0.2 million, compared to $2.9 million for the same period in 2020. The decrease was primarily attributable to foreign income tax withholdings on our revenue earned under our out-license arrangements in the prior year.

Net loss attributable to Athenex for the three months ended March 31, 2021, was $25.1 million or ($0.27) per diluted share, respectively, as compared to a net loss of $19.4 million or ($0.24) per diluted share, for the same period in 2020.

As of March 31, 2021, the Company had cash and cash equivalents of $48.0 million, restricted cash of $16.5 million, and short-term investments of $123.2 million.

Financial Guidance

In terms of product sales guidance, the Company is limiting financial guidance to only the existing product portfolio, which excludes any proprietary products, until meaningful sales data from the proprietary product, Klisyri, become available. In 2020, the Company recorded a significant amount of revenues from international customers as a result of the global pandemic. However, the Company does not see these revenues as recurring in nature. The Company continues to expand its product portfolio. The Company is affirming the guidance it provided on March 1, 2021, as it currently expects its product sales in 2021, excluding any royalties from Klisyri, to be in line with 2020 levels.

Cash Conservation Update

Given uncertainty stemming from the CRL for oral paclitaxel, the Company identified and adopted certain cash conservation measures. Considering these initial measures, and based on our current operating plan, we now expect that our cash and cash equivalents, restricted cash and short-term investments as of March 31, 2021, will enable us to meet our current operational liquidity needs and fund operations into 2H 2022.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Thursday, May 6, 2021, at 8:00 am Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

On May 6, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported it will publish first quarter 2021 financial results and provide a business update on Thursday, May 13, 2021 (Press release, Precision Biosciences, MAY 6, 2021, View Source [SID1234579375]).

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On May 6, 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 first quarter ended March 31, 2021 and discussed recent corporate updates (Press release, Bicycle Therapeutics, MAY 6, 2021, View Source [SID1234579374]).

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"We’ve had a great start to 2021, as we advance multiple Bicycle Toxin Conjugates (BTCs) in the clinic, prepare for BT7480, our lead tumor-targeted immune cell agonist, to enter the clinic later this year and continue to expand the use of our platform outside of oncology, while also significantly strengthening our balance sheet," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We plan to build on this momentum during the year, and our presentation of preclinical data at AACR (Free AACR Whitepaper) serves to highlight the potential therapeutic benefits that Bicycles may offer toward improving the treatment paradigms for people living with cancer and other serious diseases."

First Quarter 2021 and Recent Highlights

Presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. In April 2021, Bicycle presented new preclinical data describing the discovery of BT7480, a novel Nectin-4/CD137 Bicycle tumor-targeted immune cell agonistTM (Bicycle TICA) during a "New Drugs on the Horizon" session. The Company expects BT7480 to enter the clinic in the second half of 2021. Additionally, the Company presented five posters and one presentation highlighting preclinical data across multiple programs in Bicycle’s oncology pipeline. The posters and presentations are available on the Publications section of bicycletherapeutics.com.

Provided Pipeline Progress Update Across Multiple Therapeutic Programs Beyond Oncology. In March 2021, Bicycle announced progress updates for its Bicycle programs outside of oncology:

Achieved first milestone in the collaboration with Dementia Discovery Fund (DDF) and the University of Oxford’s Alzheimer’s Research UK Oxford Drug Discovery Institute (ODDI): The Company identified and optimized nM affinity Bicycles to transferrin receptor 1 (TfR1), a molecular shuttle. The three parties are collaborating to identify and characterize Bicycles that bind to and activate TREM2, a genetically validated dementia target.

Advanced the platform in multiple anti-infective areas, including antimicrobials and antivirals: Innovate UK’s Biomedical Catalyst (BMC) awarded the Company funding to advance a Bicycle inhibitor for a key cell wall biosynthesis target in Enterobacterales, Penicillin Binding Protein 3 (PBP3). Bicycle, working with investigators at the University of Warwick, intends to progress these PbP3 inhibitors, potentially the first novel class of antibiotics identified in decades, to candidate and initial toxicology testing. Additionally, under a specific Innovate UK program targeting key technologies to rapidly respond to the challenge of the COVID-19 pandemic, Bicycle received funding to support its efforts to discover new healthcare solutions to SARS-CoV-2.

Made significant progress through partnerships: Bicycle successfully discovered and advanced targets outside of oncology through its ongoing collaboration with AstraZeneca, a global biopharmaceutical company, to discover novel agents for the treatment of respiratory and cardiometabolic diseases. Two assets were transitioned to AstraZeneca’s pipeline for further development. Bicycle also identified targets in its collaboration with Bioverativ (acquired by Sanofi) for the treatment of rare hematological diseases. The collaborations successfully identified nM multi-valent inhibitors to P-Selectin, which inhibited neutrophil binding and rolling, with potential applications in sickle cell disease and other inflammatory diseases. The Bioverativ collaboration also identified the first small molecule Factor VIII mimetic for the potential treatment of Hemophilia A. Upon termination of the collaboration in 2019, these "lead stage" assets have been returned to Bicycle.

Appointed Jose-Carlos Gutierrez-Ramos, Ph.D., to its Board of Directors: In March 2021, Bicycle announced the appointment of industry veteran Dr. Gutierrez-Ramos to its Board of Directors. Dr. Gutierrez-Ramos previously served as Chair of Bicycle’s Scientific Advisory Board and has extensive experience in leading biopharmaceutical companies and in academia.

Continued to Strengthen the Balance Sheet in 2021. Since January 2021, Bicycle has completed the sale of $75.0 million through its at-the-market (ATM) offering program. Gross proceeds during the first quarter of 2021 totaled $60.6 million, with an additional $14.4 million in gross proceeds recognized in April 2021. Also during the second quarter of 2021, the Company received $2.0 million from Genentech for achieving specified criteria under the collaboration research plan. Cash as of March 31, 2021 does not include the April 2021 ATM proceeds or Genentech proceeds. In addition, in March 2021, the Company drew an additional $15.0 million available under its debt facility with Hercules Capital, Inc. and amended the loan and security agreement to extend the interest-only payment period until the second half of 2023, with the potential to further extend it into 2024, contingent on the satisfaction of performance milestones.
Financial Results

Cash was $195.9 million as of March 31, 2021, compared to $136.0 million as of December 31, 2020. The increase in cash was primarily due to net proceeds of $58.8 million from the ATM offering and net proceeds of $15.0 million from the debt facility with Hercules Capital Inc., offset by cash used in operating activities. Cash at March 31, 2021 does not include net proceeds from the ATM offering received in April 2021. Cash of $195.9 million at March 31, 2021 is expected to provide financial runway through multiple clinical milestones and into 2024.
Research and development expenses were $9.7 million for the three months ended March 31, 2021, compared to $7.8 million for the three months ended March 31, 2020. The increase in expense of $1.9 million for the three months ended March 31, 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, and increased other unallocated discovery and platform related expenses due to the timing of development activities, and increased personnel-related expenses, including $0.5 million of incremental non-cash share-based compensation expense.
General and administrative expenses were $8.1 million for the three months ended March 31, 2021, compared to $5.0 million for the three months ended March 31, 2020. The increase of $3.1 million for the three months ended March 31, 2021 as compared to the same period in the prior year was primarily due to an unfavorable effect of foreign exchange rates and an increase in personnel-related costs, including $1.2 million of incremental non-cash share-based compensation expense for the three months ended March 31, 2021.
Net loss was $16.2 million, or $(0.73) basic and diluted net loss per share, for the three months ended March 31, 2021, compared to net loss of $11.3 million, or $(0.63) basic and diluted net loss per share for three months ended March 31, 2020.

On May 6, 2021 Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported first quarter 2021 financial results (Press release, Epizyme, MAY 6, 2021, View Source [SID1234579373]).

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"Adoption of TAZVERIK has steadily increased as we continue to navigate the unique launch environment presented by COVID-19. We saw month-over-month commercial demand growth, with March 2021 representing our most successful month since launch and we look to build on this momentum as the pandemic-associated challenges begin to ease," said Robert Bazemore, President and Chief Executive Officer of Epizyme. "TAZVERIK net revenues in the first quarter of 2021 increased by 37% from the fourth quarter of 2020, driven primarily by increased adoption in follicular lymphoma. The environment we operated in during the first quarter was not substantially different from the end of last year, however we are beginning to see some encouraging signs that things are slowly beginning to return to normal as vaccine adoption progresses.

"In early March, we hosted a strategic vision call to outline the pipeline-in-a-drug potential we see in TAZVERIK and plans to expand our portfolio starting with the anticipated IND submission for our novel SETD2 inhibitor in mid-2021. We plan to share additional pre-clinical data supporting the advancement of our SETD2 program at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2021. During the Vision Call we also shared encouraging preliminary safety and activity data from ongoing combination trials in follicular lymphoma and prostate cancer and look forward to providing a steady stream of data updates from these and our many other planned and ongoing trials over the next few years."

Recent Progress

Commercial Execution: TAZVERIK generated net product revenue in Epithelioid Sarcoma (ES) and Follicular Lymphoma (FL) of $6.2 million in the first quarter of 2021, with March 2021 representing our highest level of commercial demand since launch. Commercial bottle demand growth was 31% in the first quarter compared to the fourth quarter of 2020, while total revenue grew by 37%. New prescribing accounts increased 38% in the first quarter of 2021 compared to the fourth quarter of 2020, including broader adoption among community practice. This is despite the continued negative impact COVID-19 had on patient visits to physicians and new patient starts across all lines of treatment as well as the ability of our field-based teams to fully access physicians treating ES and FL patients.
EZH-302 Phase 1b/3 Confirmatory Study of TAZVERIK in Follicular Lymphoma: The combination of TAZVERIK with R2 (Lenalidomide and Rituximab) is being evaluated in a Phase 1b/3 confirmatory study in relapsed / refractory FL patients. Preliminary safety and activity data of 13 patients from the 400 mg, 600 mg and 800 mg cohorts of the Phase 1b safety run-in were presented during Epizyme’s Vision Call in March showing encouraging initial treatment responses in each dose group, and adverse events that were in line with expectations based on the respective safety profiles of the individual agents. Epizyme plans to submit an update to this safety run-in for presentation at the 2021 ASH (Free ASH Whitepaper) Annual Meeting later this year.

Based on recent discussions with the U.S. Food and Drug Administration (FDA), Epizyme has aligned on an important change to the Phase 3 protocol whereby the second interim analysis will include an efficacy evaluation once 65% of progression free survival (PFS) events have occurred. This allows access to efficacy data earlier than previously expected and may provide an opportunity to stop the study early should the predefined treatment effect be realized. Based on these discussions with FDA, Epizyme has also expanded the Phase 1b portion of the study to include a minimum of 15 patients in the cohorts of 600 mg BID and 800 mg BID to help inform selection of the Phase 3 dose. Enrollment is nearly complete in these two cohorts and patients are being evaluated for follow-up of three months before initiating the Phase 3 randomization portion of the trial.
Additional Ongoing Clinical Trials of Tazemetostat in Follicular Lymphoma: EZH-1401, the Company’s Phase 2 trial evaluating TAZVERIK plus Rituxan in relapsed / refractory FL continues to move forward as planned and is actively enrolling. Patient enrollment also continues in the Lymphoma Study Association (LYSA) trial in front-line FL and Diffuse Large B-cell Lymphoma (DLBCL), as well as other investigator sponsored trials.
EZH-1101 Phase 1b/2 Study of Tazemetostat in Prostate Cancer: The combination of tazemetostat with standard-of-care treatments, enzalutamide or abiraterone, was evaluated in the Phase 1b safety run-in portion of the EZH-1101 trial which enrolled a total of 21 men with metastatic prostate cancer. The Phase 1b protocol allowed patients to enroll who had previously failed enzalutamide, abiraterone, first generation anti-androgen receptor therapies or short course chemotherapy. In the study, patients received either abiraterone plus tazemetostat plus prednisone or enzalutamide plus tazemetostat. Based on encouraging preliminary safety and activity data, particularly in the enzalutamide plus tazemetostat group, Epizyme has initiated enrollment in the Phase 2 efficacy portion of this study which will evaluate enzalutamide plus tazemetostat compared to enzalutamide alone. Epizyme plans to submit an update to the Phase 1b safety run-in for presentation at a medical congress later this year.
EZH-301 Confirmatory Phase 1b/3 Study of TAZVERIK in Epithelioid Sarcoma: The combination of TAZVERIK with doxorubicin compared with doxorubicin plus placebo is being evaluated in a Phase 1b/3 confirmatory study as a front-line treatment for ES patients. We have completed the planned enrollment in the Phase 1b safety run-in portion of the trial and the Phase 3 efficacy expansion portion of the trial remains on track for initiation. Preliminary data from the Phase 1b portion of this study has been accepted as a poster presentation at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting in June.
Tazemetostat Basket Trials in Additional Hematologic Malignancies and Solid Tumors: Epizyme plans to initiate two signal finding basket studies to evaluate tazemetostat safety and efficacy across multiple new types of hematologic malignancies and solid tumors. With this approach, the Company plans to study multiple combinations with standard-of-care therapies and novel mechanisms of action to expand the potential of tazemetostat. Epizyme plans to initiate both basket studies in the second half of 2021.
Planned IND Submission for Epizyme’s Novel SETD2 Inhibitor: Based on the potential of SETD2 inhibition in multiple settings, including high risk t(4;14) multiple myeloma and in other B-cell malignancies such as large-cell lymphoma, as monotherapy and in combination with existing and emerging therapies including tazemetostat, Epizyme is planning to submit an Investigational New Drug (IND) application with the FDA in mid-2021 and expects to initiate a first-in-human clinical trial this year.
First Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $298.9 million as of March 31, 2021, as compared to $373.6 million as of December 31, 2020.
Revenue: Total revenue for the first quarter of 2021 was $7.6 million, compared to $1.4 million for the first quarter of 2020. Total revenue for the first quarter of 2021 comprised of $6.2 million in net sales of TAZVERIK in the U.S. and $1.4 million in collaboration and other revenue.
Operating Expenses: Total GAAP operating expenses were $72.0 million for the first quarter of 2021 compared to $52.7 million for the first quarter of 2020. Total non-GAAP adjusted operating expenses were $63.7 million for the first quarter of 2021 compared to $45.7 million for the first quarter of 2020.
Cost of revenue: GAAP cost of revenue, which reflects the costs of TAZVERIK units sold, amortization of intangible assets, third-party royalties on net product revenue and costs of tazemetostat API and drug product sold to the Company’s licensees or collaborators, was $2.9 million for the first quarter of 2021 compared to $0.6 million in the first quarter of 2020. Non-GAAP adjusted cost of revenue was $1.8 million for the first quarter of 2021 compared to $0.3 million for the first quarter of 2020.
R&D expenses: GAAP R&D expenses were $32.7 million for the first quarter of 2021 compared to $25.2 million for the first quarter of 2020. Non-GAAP adjusted R&D expenses were $30.3 million for the first quarter of 2021 compared to $22.9 million for the first quarter of 2020.
SG&A expenses: GAAP SG&A expenses were $36.4 million for the first quarter of 2021 compared to $27.0 million for the first quarter of 2020. Non-GAAP adjusted SG&A expenses were $31.5 million for the first quarter of 2021 compared to $22.5 million for the first quarter of 2020.
Net Loss (GAAP): Net loss attributable to common stockholders was $70.3 million, or $0.69 per share, for the first quarter of 2021, compared to $50.9 million, or $0.51 per share, for the first quarter of 2020.
2021 Financial Guidance

Based on its current operating plans, Epizyme expects its current cash runway to extend into 2023. Additionally, the Company expects its non-GAAP adjusted operating expenses for 2021 to be between $235 and $255 million.
A reconciliation of non-GAAP adjusted financial measures directly comparable to GAAP financial measures is presented in the table attached to this press release.
Conference Call Information

Epizyme will host a conference call today, May 6, at 7:30 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 4139845. A webcast, as well as supplemental slides to support the webcast, will be available in the investor section of the Company’s website at www.epizyme.com, and will be archived for 60 days following the call.

About Non-GAAP Financial Measures

In addition to financial information prepared in accordance with the U.S. generally accepted accounting principles (GAAP), this press release includes the following non-GAAP financial measures: total non-GAAP adjusted operating expenses on a historical and projected basis, non-GAAP adjusted R&D expenses on a historical basis and non-GAAP adjusted SG&A expenses on a historical basis. Epizyme derives these non-GAAP financial measures by excluding certain expenses and other items from the respective GAAP financial measure, that is most directly comparable to each non-GAAP financial measure. Specifically, the non-GAAP financial measures exclude stock-based compensation expense and depreciation and amortization of intangibles. The company’s management believes that these non-GAAP financial measures are useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to total operating expenses is not available without unreasonable effort primarily due to the company’s inability to predict with reasonable certainty the amount of future stock-based compensation expense.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

On May 6, 2021 Cardinal Health (NYSE: CAH) reported third-quarter fiscal year 2021 revenue of $39.3 billion, in-line with the third quarter of last year (Press release, Cardinal Health, MAY 6, 2021, View Source [SID1234579372]). Third-quarter GAAP operating earnings decreased 16% to $473 million, primarily due to the write-down of the net assets held for sale from the planned divestiture of the Cordis business. Third-quarter GAAP diluted earnings per share (EPS) decreased to $0.40, due to the previously-disclosed tax effect of the litigation charge in the first quarter.

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Non-GAAP operating earnings decreased 4% to $689 million in the quarter due to the negative impact from COVID-19, primarily concentrated in the Pharmaceutical segment. Non-GAAP diluted EPS decreased 6% to $1.53 in the quarter, reflecting a higher non-GAAP effective tax rate, partially offset by lower interest expense.

"We remain focused on serving our customers and their patients and continue to advance our strategic priorities," said Mike Kaufmann, CEO of Cardinal Health. "With our resilient business model and strong fundamentals, we are navigating the effects of the pandemic and finding opportunities to adapt, innovate and invest for future growth."

Third-quarter revenue for the Pharmaceutical segment was flat at $35.1 billion. This reflects sales growth from Pharmaceutical Distribution and Specialty Solutions customers in the current period compared against the unfavorable prior-year comparison of the COVID-19-related acceleration in overall pharmaceutical sales.

Pharmaceutical segment profit decreased 4% to $511 million in the third quarter, primarily due to COVID-19-related volume declines in the company’s generics program. This was partially offset by a higher contribution from brand sales mix.

Third-quarter revenue for the Medical segment increased 3% to $4.2 billion, driven by a net positive impact from COVID-19 on products and distribution. This increase was primarily due to the impact of personal protective equipment (PPE) sales and higher volumes in our Lab business, partially offset by the adverse effects of reduced elective procedures.

Medical segment profit decreased 2% to $174 million in the third quarter. Cost savings, including global manufacturing efficiencies, were offset by a decline in products and distribution. Additionally, the segment experienced a slight negative impact due to COVID-19.

Tax rate
During the third quarters of fiscal 2021 and 2020, GAAP effective tax rates were 72.8% and 26.8%, respectively. The increase was primarily due to the previously-disclosed tax effect of the litigation charge in the first quarter. Non-GAAP effective tax rates were 31.2% and 25.7%, respectively, for the third quarters of fiscal 2021 and 2020. Third-quarter fiscal 2021 effective tax rates reflect the resolution of all open issues with the IRS for fiscal years 2008 to 2010 as well as certain transfer pricing matters for fiscal years 2011 to 2014, which also impacted reserves for later years.

Fiscal year 2021 outlook1
Cardinal Health narrowed its fiscal year 2021 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to $5.90 to $6.05, from the prior range of $5.85 to $6.10.

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 Board of Directors approved a 1% increase in the company’s quarterly dividend from $0.4859 per share to $0.4908 per share, or $1.96 on an annualized basis. The dividend will be payable on July 15, 2021 to shareholders of record at the close of business on July 1, 2021.
Cardinal Health announced that it signed a definitive agreement to sell its Cordis business to Hellman & Friedman (H&F) for approximately $1 billion. The company anticipates the transaction to close in the first quarter of fiscal 2022.
Cardinal Health recently launched Outcomes, a digital ecosystem that provides personalized medication therapy management, patient engagement and telepharmacy through its Connect platform, connecting pharmacists, payers and pharmaceutical companies to improve medication adherence, drive better outcomes and lower the cost of care.
Cardinal Health recently announced a partnership with FourKites, the largest predictive supply chain visibility platform, to create a cognitive supply chain network that combines real-time visibility, machine learning and artificial intelligence to facilitate the flow of inventory throughout the supply chain.
Cardinal Health Specialty Solutions launched Cardinal Health Navista Tech Solutions (TS), an advanced suite of technology solutions to help community oncologists improve outcomes and costs associated with patient treatment as they transition to value-based care.
Cardinal Health was awarded a $57.8 million contract, including options that if exercised by the U.S. Department of Health and Human Services (HHS) could reach $91.6 million, for the storage and distribution of 80,000 pallets of personal protective equipment (PPE) to support the Strategic National Stockpile (SNS).
Upcoming webcasted investor events

Bank of America Healthcare Conference at 8:45 a.m. Eastern, May 11
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss third-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 May 5, 2022.