Oncternal Provides Business Update and Announces First Quarter 2021 Financial Results

On May 6, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the first quarter of 2021 (Press release, Oncternal Therapeutics, MAY 6, 2021, View Source [SID1234579338]). Oncternal management will host a webcast today at 5:00 p.m . ET to discuss its first quarter of 2021 financial results and to provide a business update.

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"We are continuing to advance our ROR1-focused platform in both liquid and solid tumors, while laying the groundwork for developing new ROR1 targeting cell therapies. Based on encouraging data recently reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, we are evaluating cirmtuzumab for other clinical development opportunities in solid tumors while continuing our FDA dialogue on a potential registration strategy in mantle cell lymphoma (MCL). In addition, we are supporting TK216, an ETS inhibitor which has generated encouraging results in Ewing sarcoma," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We also look forward to presenting several key clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held virtually from June 4-8, 2021."

Recent Highlights

In April 2021, we presented two scientific posters at the AACR (Free AACR Whitepaper) Annual Meeting, which showcased the promise of cirmtuzumab in treating solid tumors.
In a Phase 1b investigator-initiated clinical trial in heavily pre-treated patients with metastatic HER2-negative breast cancer treated with a combination of cirmtuzumab and paclitaxel, eight of 14 evaluable patients had a partial response (PR), one of which remained durable for 52 weeks, for an objective response rate (ORR) of 57%. Four additional patients (29%) had stable disease (SD). These results were consistent with the previously reported interim results of the study, and compared favorably to historical results for single-agent paclitaxel, particularly for patients such as these who had received a median of six prior therapies for metastatic disease. Cirmtuzumab when given with paclitaxel was well-tolerated and demonstrated no added toxicity over what was expected with paclitaxel alone. The trial is expected to enroll a total of 15 evaluable patients.
In a preclinical study of cirmtuzumab used to treat high-grade serous ovarian cancer (HGSOC) and endometrial cell lines in vitro alone or in combination with chemotherapeutic agents cisplatin and paclitaxel, cirmtuzumab demonstrated single agent activity and enhanced the anti-proliferative effects of chemotherapeutic agents in both ovarian and endometrial cancer cell models. Oncternal is currently evaluating next steps for cirmtuzumab in solid tumors including breast and ovarian cancer.
In April 2021, we appointed Chase Leavitt as General Counsel.
In April 2021, we announced that updated interim clinical trial results from Oncternal’s study of TK216 in patients with Ewing sarcoma will be presented in an oral session, and updated interim clinical trial results from Oncternal and UCSD’s study of cirmtuzumab plus ibrutinib in patients with MCL or chronic lymphocytic leukemia (CLL) will be presented in a poster session at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2021.
Expected Upcoming Milestones

Cirmtuzumab (ROR1 antibody) programs
Clinical data update for patients with MCL and CLL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting
Preclinical data in additional ROR1-expressing tumors is expected to be available in the third quarter of 2021
ROR1 CAR-T program
First-in-human dosing is expected in the first half of 2022
TK216 (ETS inhibitor) program
Clinical data update for patients with Ewing sarcoma treated in the ongoing Phase 1/2 study will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting
Preclinical data in additional ETS-driven tumors is expected to be available in the third quarter of 2021
First Quarter 2021 Financial Results

Our grant revenue was $0.7 million for the first quarter ended March 31, 2021. Our grant revenue is derived from a sub-award under a grant from the California Institute for Regenerative Medicine (CIRM) to UC San Diego, which was awarded to advance our Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL or CLL.

Our total operating expenses for the first quarter ended March 31, 2021 were $6.7 million. Research and development expenses for the quarter totaled $3.9 million, and general and administrative expenses for the quarter totaled $2.8 million. Net loss for the first quarter was $5.9 million, or a loss of $0.12 per share, basic and diluted.

As of March 31, 2021, we had $111.2 million in cash and cash equivalents. We believe these funds will be sufficient to fund our operations into 2023. As of March 31, 2021, we had approximately 49.4 million shares of common stock outstanding.

Management Webcast

As previously announced, Oncternal will host a webcast today, May 6, 2021, at 5:00 p.m. ET (2:00 p.m. PT). The live webcast will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

McKESSON REPORTS FISCAL 2021 FOURTH-QUARTER AND FULL-YEAR RESULTS

On May 6, 2021 McKesson Corporation (NYSE:MCK) reported results for the fourth quarter and fiscal year ended March 31, 2021 (Press release, McKesson, MAY 6, 2021, View Source [SID1234579354]).

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"Our notable performance in fiscal 2021 reflects the continued momentum in our businesses and is a testament to the leadership role McKesson plays in the healthcare supply chain. McKesson’s differentiated capabilities make us the partner of choice for our customers and government entities in their COVID-19 response efforts. I am proud of our employees and what we have accomplished together," said Brian Tyler, chief executive officer. "Despite the dynamic macro environment, the business demonstrated strong execution as we grew Adjusted Earnings per diluted share by 15%. These results allowed us to generate $3.9 billion of Free Cash Flow."

"As we enter fiscal 2022, our top priorities remain the safety of our employees, the success of our customers, and fulfilling our leadership responsibility as the centralized distributor of COVID-19 vaccines and ancillary supplies in the U.S.," Mr. Tyler continued. "We have positioned the business for long-term growth through strategic investments in the areas of oncology and biopharma services and successful transformation of our operating model. Our accomplishments in fiscal 2021 are the foundation for the future and we remain confident in our ability to create long-term value for our shareholders."

Fourth-quarter revenues were $59.1 billion, up 1% from a year ago, driven by market growth and higher volumes from retail national account customers in the U.S. Pharmaceutical segment, partially offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic. Full-year revenues were $238.2 billion, up 3% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to market growth and higher specialty volumes, partially offset by branded to generic conversions.

Fourth-quarter earnings per diluted share from continuing operations was $4.15 compared to $5.82 a year ago, a decrease of 29%. Full-year loss per diluted share from continuing operations of ($28.26) included a pre-tax $8.1 billion expense accrual related to the estimated liability for opioid-related claims. This charge was taken in the company’s third-quarter and is not included in full-year Adjusted Earnings per diluted share.

Fourth-quarter Adjusted Earnings per diluted share was $5.05 compared to $4.27 a year ago, an increase of 18%, primarily driven by the contribution from COVID-19 vaccine distribution and kitting programs with the U.S. government and a lower share count, partially offset by a higher tax rate and the prior year contribution from the company’s now separated investment in Change Healthcare LLC ("Change Healthcare"). Fourth-quarter Adjusted Earnings per diluted share included pre-tax net gains of approximately $44 million, or $0.21 per diluted share, associated with McKesson Ventures’ equity investments.

Full-year Adjusted Earnings per diluted share was $17.21 compared to $14.95 a year ago, an increase of 15%, primarily driven by a lower share count and the contribution from COVID-19 vaccine distribution and kitting programs with the U.S. government, partially offset by the prior year contribution from the company’s now separated investment in Change Healthcare. Full-year Adjusted Earnings per diluted share included pre-tax net gains of approximately $133 million, or $0.60 per diluted share, associated with McKesson Ventures’ equity investments.

For the full year, McKesson returned $1.0 billion of cash to shareholders, which included $770 million of common stock repurchases and $276 million of dividend payments. During the fiscal year, McKesson generated cash from operations of $4.5 billion, and invested $641 million in capital expenditures, resulting in Free Cash Flow of $3.9 billion.

Business Highlights

U.S. Pharmaceutical’s operational excellence and scaled distribution network was highlighted by the successful distribution of over 150 million COVID-19 vaccines through April 30, 2021.
McKesson continued to invest in Ontada, the company’s differentiated oncology technology and insights business and also joined MYLUNG, a collaborative real-world research consortium designed to advance precision medicine for non-small cell lung cancer patients.
Prescription Technology Solutions finished fiscal 2021 with positive momentum and Access for More Patients (AMP) contributed to profit growth in the fourth quarter.
Medical-Surgical Solutions played a central role in the COVID-19 response efforts, assembling and distributing the ancillary supply kits needed for COVID-19 vaccinations and distributing COVID-19 tests to healthcare provider customers.
Segment Financials

U.S. Pharmaceutical Segment

Fourth-Quarter:

Revenues were $47.0 billion, an increase of 3%, driven by market growth and higher volumes from retail national account customers, partially offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic and branded to generic conversions.
Segment Operating Profit was $892 million. Adjusted Segment Operating Profit was $813 million, an increase of 7% from a year ago, driven by the contribution from COVID-19 vaccine distribution, offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic and higher operating costs to support oncology growth initiatives.
Full-Year:

Revenues were $189.3 billion, an increase of 4%, driven by market growth and higher specialty volumes, partially offset by branded to generic conversions.
Segment Operating Profit was $2.8 billion. Adjusted Segment Operating Profit was $2.7 billion, an increase of 3% from a year ago, driven by growth in distribution of specialty products to providers and the contribution from COVID-19 vaccine distribution, offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic and higher operating costs to support oncology growth initiatives.
Prescription Technology Solutions Segment

Fourth-Quarter:

Revenues were $789 million, an increase of 7%, driven by higher volumes of technology and service offerings to support biopharma customers.
Segment Operating Profit was $125 million. Adjusted Segment Operating Profit was $146 million, an increase of 11%, driven by organic growth from access and adherence solutions including the contribution from AMP.
Full-Year:

Revenues were $2.9 billion, an increase of 7%, driven by higher volumes of technology and service offerings to support biopharma customers.
Segment Operating Profit was $395 million. Adjusted Segment Operating Profit was $467 million, flat to prior year. Organic growth from access and adherence solutions was offset by higher operating costs to support biopharma services growth initiatives.
Medical-Surgical Solutions Segment

Fourth-Quarter:

Revenues were $2.7 billion, an increase of 23%, driven by demand for COVID-19 tests.
Segment Operating Profit was $171 million. Adjusted Segment Operating Profit was $192 million, an increase of 13%, driven by demand for COVID-19 tests and the contribution from kitting and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program, partially offset by inventory charges on certain personal protective equipment (PPE) incurred to support customers through the extraordinary demand related to the COVID-19 pandemic.
Full-Year:

Revenues were $10.1 billion, an increase of 22%, driven by demand for COVID-19 tests and personal protective equipment in the Primary Care and Extended Care businesses.
Segment Operating Profit was $707 million. Adjusted Segment Operating Profit was $805 million, an increase of 19%, driven by demand for COVID-19 tests and the contribution from kitting and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program, partially offset by inventory charges on certain PPE and related products.
International Segment

Fourth-Quarter:

Revenues were $8.6 billion. On an FX-adjusted basis, revenues were $7.9 billion, a decline of 18%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance.
Segment Operating Profit was $76 million. On an FX-adjusted basis, Adjusted Segment Operating Profit was $126 million, a decline of 8%.
Full-Year:

Revenues were $36.0 billion. On an FX-adjusted basis, revenues were $34.9 billion, a decline of 9%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance.
Segment Operating Loss was ($37) million, primarily driven by a GAAP-only pre-tax long-lived asset impairment charge of $115 million. On an FX-adjusted basis, Adjusted Segment Operating Profit was $466 million, an increase of 1%.
Company Updates

McKesson’s commitment to transform its operating model resulted in annual pre-tax cost savings in excess of $400 million, achieving the company’s three-year target of $400 million to $500 million by the end of Fiscal 2021.
Susan Shiff joined McKesson as president of Ontada, the company’s oncology technology and insights business within the U.S. Pharmaceutical segment.
As part of the company’s strategy and actions towards better health for people and the planet, McKesson committed to set science-based targets to reduce the company’s greenhouse gas emissions.
Fiscal 2022 Outlook

McKesson expects full-year fiscal 2022 Adjusted Earnings per diluted share of $18.85 to $19.45, which reflects Adjusted Operating Profit growth in all segments coupled with disciplined, efficient capital deployment, including approximately $2 billion of share repurchases. Fiscal 2022 Adjusted Earnings per diluted share guidance assumes $0.40 to $0.50 related to U.S. government COVID-19 vaccine distribution and $0.10 to $0.20 related to the kitting and distribution of ancillary supplies.

The fiscal 2022 outlook is based on the following key assumptions and expectations and is subject to risks and uncertainties such as those described in the Cautionary Statements below:

Additional modeling considerations will be provided in the earnings call presentation.

Other remaining businesses

Other reflects equity earnings and charges for retrospective periods for the company’s previous investment in Change Healthcare, which was separated from the company during the fourth quarter of fiscal 2020.

Conference Call Details

The company has scheduled a conference call for today, Thursday, May 6th 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:

BofA Securities Virtual 2021 Healthcare Conference, May 13, 2021
Goldman Sachs 42nd Annual Global Healthcare Conference, June 8, 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 Equity Income from Change Healthcare, 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, gains from antitrust legal settlements, 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.

Regeneron Reports First Quarter 2021 Financial and Operating Results

On May 6, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the first quarter of 2021 and provided a business update (Press release, Regeneron, MAY 6, 2021, View Source [SID1234579371]).

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"Regeneron had a strong first quarter highlighting our continued evolution into a company with multiple durable product lines helping people with a range of serious diseases including COVID-19," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We recently reported positive Phase 3 results for REGEN-COV in both the COVID-19 outpatient treatment and prevention settings and are working with national and state authorities to improve access. We expect continued growth with EYLEA in retinal diseases, as well as with Dupixent through further penetration in existing indications and a broad Phase 3 development program. In oncology, we are in the early days of launching Libtayo for advanced basal cell carcinoma and non-small cell lung cancer and recently announced positive pivotal data in cervical cancer with regulatory submissions planned for later this year."

"Our business is off to a strong start in 2021 with double-digit top- and bottom-line growth," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "Our financial strength and solid execution across the business continue to position the Company for sustainable long-term growth."

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

In March 2021, JAMA Ophthalmology announced initial results from the National Institutes of Health-sponsored Protocol W trial evaluating EYLEA in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR). The two-year data confirmed results from the Company-sponsored PANORAMA trial and demonstrated that EYLEA significantly reduced the risk of developing vision-threatening complications with an every-16-weeks dosing regimen. The Company plans to submit a supplemental Biologics License Application (sBLA) for an every-16-weeks dosing regimen in patients with NPDR later this year.
Dupixent (dupilumab)

The U.S. Food and Drug Administration (FDA) accepted for review, with a target action date of October 21, 2021, the sBLA for Dupixent for children aged 6 to 11 years with moderate-to-severe asthma. A regulatory application for Dupixent for children aged 6 to 11 years with severe asthma was also submitted in the European Union (EU).
REGEN-COVTM (casirivimab with imdevimab), a dual antibody cocktail to SARS-CoV-2 virus

In March 2021, the Company announced positive top-line results from the Phase 3 treatment trial in high-risk COVID-19 outpatients. The trial met its primary endpoint, showing that REGEN-COV significantly reduced the risk of hospitalization or death by approximately 70% with both REGEN-COV doses (1,200 mg and 2,400 mg) compared to placebo. The trial also met key secondary endpoints, including the ability to reduce symptom duration. Based on these results, the Company submitted a request to the FDA to update the Emergency Use Authorization (EUA) to the lower 1,200 mg dose.
In April 2021, the National Institutes of Health (NIH) COVID-19 Treatment Guidelines were updated to strongly recommended that REGEN-COV be used in non-hospitalized COVID-19 patients at high risk of clinical progression.
In April 2021, the Company announced positive results from the Phase 3 COVID-19 prevention trial in uninfected household contacts of SARS-CoV-2 infected individuals. The trial met its primary and key secondary endpoints, showing that REGEN-COV 1,200 mg administered subcutaneously reduced the risk of symptomatic infections by 81%. The Company has shared this data with the FDA and requested that the EUA be expanded to include COVID-19 prevention for appropriate populations.
In April 2021, the Company also announced positive data from a Phase 3 treatment trial in recently infected asymptomatic COVID-19 patients. The trial met all primary and key secondary endpoints, and demonstrated that the 1,200 mg subcutaneous injection of REGEN-COV reduced the risk of progressing to symptomatic COVID-19 by 31%, and by 76% after the third day.
In January 2021, the Company announced a second agreement with the U.S. government to manufacture and deliver REGEN-COV. The U.S. government has agreed to acquire up to 1.25 million additional doses at the lowest treatment dose authorized or approved by the FDA for the indication authorized under the EUA, resulting in payments to the Company of up to $2.625 billion in the aggregate. The Company anticipates being able to provide at least 1 million doses by June 30, 2021 if the EUA is updated to the lower 1,200 mg dose. The U.S. government is obligated to purchase all filled and finished doses of drug product delivered by June 30, 2021, and may accept additional doses through September 30, 2021 at its discretion. A number of factors may impact the quantity of filled and finished product supplied by June 30, 2021, including manufacturing considerations and authorized dose levels.
Libtayo (cemiplimab)

In February 2021, the FDA approved Libtayo for the first-line treatment of patients with advanced NSCLC.
In February 2021, the FDA also approved Libtayo for the treatment of metastatic or locally advanced BCC.
In March 2021, the Company and Sanofi announced positive results from the Phase 3 trial in cervical cancer, which was stopped early based on a recommendation by the Independent Data Monitoring Committee (IDMC). The results demonstrated an overall survival benefit compared to chemotherapy. Regulatory submissions are planned for later this year.
Evkeeza, an antibody to ANGPTL3

In February 2021, the FDA approved Evkeeza for the treatment of adults and adolescents with HoFH.
Bispecific Antibodies

The Company retained the exclusive rights to develop and commercialize two bispecific antibodies targeting BCMAxCD3 (REGN5458 and REGN5459) and a bispecific antibody targeting MUC16xCD3 (REGN4018) as Sanofi did not exercise its options to license rights to these product candidates under the companies’ immuno-oncology collaboration. REGN5458 and REGN5459 are in clinical development for multiple myeloma, and REGN4018 is being studied in ovarian cancer.
REGN1908-1909, a multi-antibody therapy to Fel d 1

In February 2021, the Company announced that the Phase 2 study in cat allergic patients with mild asthma met its primary and key secondary endpoints. The Company plans to initiate a Phase 3 study in cat allergic asthmatics later this year.
First Quarter 2021 Financial Results

Revenues

Total revenues increased by 38% to $2.529 billion in the first quarter of 2021, compared to $1.828 billion in the first quarter of 2020. Total revenues excluding REGEN-COV increased by 20% to $2.200 billion in the first quarter of 2021, compared to the first quarter of 2020.

Net product sales recorded by the Company consist of the following:

Total revenues also include collaboration revenues(2) of $754 million in the first quarter of 2021, compared to $528 million in the first quarter of 2020. Sanofi collaboration revenue increased primarily due to the Company’s share of profits from commercialization of antibodies, which were $261 million in the first quarter of 2021, compared to $171 million in the first quarter of 2020. The change in the Company’s share of profits from commercialization of antibodies was primarily driven by higher Dupixent profits. In the first quarter of 2021, the Company also recorded Roche collaboration revenue of $67 million in connection with the Company’s share of gross profits from sales of the casirivimab with imdevimab antibody cocktail (known as REGEN-COV in the United States).

Refer to Table 4 for a summary of collaboration revenue.

The higher GAAP and non-GAAP R&D expenses in the first quarter of 2021 were primarily due to costs incurred in connection with development activities related to REGEN-COV.
The increase in GAAP and non-GAAP SG&A expenses in the first quarter of 2021 was primarily due to an increase in product launch-related costs and higher headcount-related costs.
The increase in COGS in the first quarter of 2021 was primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV in the United States, as well as Praluent in the United States (which were recorded by Sanofi prior to April 1, 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 gains on equity securities of $144 million in the first quarter of 2021, compared to net losses of $57 million in the first quarter of 2020.

In the first quarter of 2021, the Company’s GAAP effective tax rate was 11.0%, compared to 6.6% in the first quarter of 2020. The GAAP effective tax rate for the first quarter 2021 was positively impacted, compared to the U.S. federal statutory rate, primarily by the reversal of liabilities related to uncertain tax positions, stock-based compensation, income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, and federal tax credits for research activities. In the first quarter of 2021, the non-GAAP effective tax rate was 10.5%, compared to 9.5% in the first quarter of 2020.

GAAP net income per diluted share was $10.09 in the first quarter of 2021, compared to GAAP net income per diluted share of $5.43 in the first quarter of 2020. Non-GAAP net income per diluted share was $9.89 in the first quarter of 2021, compared to non-GAAP net income per diluted share of $6.60 in the first quarter of 2020. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

In January 2021, the Company’s board of directors authorized a new share repurchase program to repurchase up to $1.5 billion of the Company’s common stock. Repurchases may be made from time to time at management’s discretion through a variety of methods. The program has no time limit and can be discontinued at any time. During the first quarter of 2021, the Company repurchased shares of common stock under the program, and recorded the cost of the shares received, or $323 million, as Treasury Stock. As of March 31, 2021, $1.177 billion remained available for share repurchases under the program.

Net cash provided by operating activities in the first quarter of 2021 was $669 million, compared to $698 million in the first quarter of 2020, resulting in $553 million in free cash flow for the first quarter of 2021, compared to $528 million for the first quarter of 2020.

2021 Financial Guidance(3)

The Company’s full year 2021 financial guidance consists of the following components:

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its first quarter 2021 financial and operating results on Thursday, May 6, 2021, at 8:30 AM Eastern Time. To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 7794757. 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.

UroGen Pharma to Report First Quarter 2021 Financial Results on Thursday, May 13, 2021

On May 6, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that it will report first quarter 2021 financial results on Thursday, May 13, 2021, prior to the open of the market (Press release, UroGen Pharma, MAY 6, 2021, View Source [SID1234579387]). The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

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Audio Webcast
The webcast will be made available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

Gossamer Bio Announces First Quarter 2021 Financial Results and Provides Corporate Update

On May 6, 2021 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the first quarter of 2021 and provided a corporate update (Press release, Gossamer Bio, MAY 6, 2021, View Source [SID1234579405]).

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Clinical-Stage Product Candidate Updates

Seralutinib (GB002): Inhaled PDGFR, CSF1R and C-KIT Inhibitor for PAH

Enrollment ongoing in the TORREY Study, a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance (PVR) from baseline at week 24. Topline data from the TORREY study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Key opinion leader-led webcast and presentation regarding PAH and seralutinib held on December 15, 2020 available through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com.
GB004: Oral, Gut-Targeted HIF-1α Stabilizer for Inflammatory Bowel Disease (IBD)

Enrollment ongoing in the SHIFT-UC Study, a Phase 2 clinical trial in patients with active UC despite treatment with 5-ASAs. The primary endpoint is proportion of patients with clinical remission at week 12. Topline data from the SHIFT-UC study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Key opinion leader-led webcast and presentation regarding IBD and GB004 held on February 18, 2021 available through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com.
GB1275: Oral CD11b Modulator for Solid Tumor Oncology Indications

Enrollment ongoing in a Phase 1 expansion cohort studying the recommended Phase 2 dose in KEYNOTE-A36, a Phase 1/2 clinical trial, including patients with gastric or esophageal cancer who have progressed after initial response to anti-PD-1 therapy and patients with advanced MSS colorectal cancer.
Additional clinical data from the ongoing GB1275 Phase 1/2 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting being held virtually from June 4 – 8, 2021. Oral presentation details:
Abstract Number: 2505
Abstract Title: Preliminary clinical and biologic results of GB1275, a first-in-class oral CD11b modulator, alone and with pembrolizumab, in advanced solid tumors (KEYNOTE-A36)
Session Title: Developmental Therapeutics – Immunotherapy
Session Date and Time: Monday, June 7, 2021 from 3:00 pm – 6:00 pm ET
Corporate Updates

Gossamer announced the promotion of Laura Carter, Ph.D. and Caryn Peterson to Chief Scientific Officer and Executive Vice President, Regulatory Affairs, respectively.
Financial Results for the Quarter Ended March 31, 2021

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2021, were $453.3 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the second half of 2023.
Research and Development (R&D) Expenses: For the quarter ended March 31, 2021, R&D expenses were $41.8 million, compared to R&D expenses of $41.4 million for the same period in 2020.
General and Administrative (G&A) Expenses: For the quarter ended March 31, 2021, G&A expenses were $11.3 million, compared to $10.7 million for the same period in 2020.
Net Loss: Net loss for the quarter ended March 31, 2021, was $57.6 million, or $0.78 per share, compared to a net loss of $54.1 million, or $0.87 per share, for the same period in 2020.